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560 VENTILATOR CLINICIAN`S MANUAL

1. VEN 10004 Figure 6 11 Air Inlet Filter f WARNING The air inlet filter is not reusable do not attempt to wash clean or reuse it Failing to replace a dirty air inlet filter or operating the ventilator without a filter may cause serious damage to the ventilator Bacteria Filter It is highly recommended that you install a bacteria filter see Figure 6 12 on both single and double limb circuits In a double limb configuration two bacteria filters are used one at the TO PATIENT A port and the other at the FROM PATIENT K port e e Connected to the TO PATIENT 49 port This filter protects the ventilator from contamination by the patient primarily rebreathed gas Refer to Figure 6 8 item 1 e Connected to the FROM PATIENT aK port This filter protects the internal exhalation flow sensor from the gases exhaled by the patient Refer to Figure 6 8 item 10 Figure 6 12 Bacteria Filter Refer to the manufacturer s instructions for more information about the use and maintenance of the bacteria filter s Puritan Bennett 560 Ventilator Clinician s Manual 6 11 Installation and Assembly 6 6 Humidifier 6 7 A The humidifier Figure 6 13 adds moisture water vapour and warms the gas in the patient circuit It is inserted into the patient circuit between the main outlet and the patient refer to Figure 6 7 and Figure 6 8 WARNING During invasive ventilation when an artificial
2. Volume Volume Time Time A C mode guarantees a maximum period between breaths as determined by the Breath Rate setting In the waveform below the ventilator delivers a controlled machine breath and calculates the time before another controlled breath must be delivered The ventilator delivers a second controlled breath at the conclusion of the machine calculated breath time for simplicity we will use the term period for machine calculated breath time Following the second controlled breath but before another period can elapse the patient s effort triggers an assisted or patient initiated breath This restarts the period At the conclusion of the period the ventilator delivers another controlled breath Puritan Bennett 560 Ventilator Clinician s Manual Breath Types Period Period Period Airway Pressure Patient Initiated Breath Machine breath Machine breath Machine breath Time D 2 2 Pressure Control Breaths in Assist Control Mode In Assist Control mode P A C each delivered breath will maintain the selected pressure P Control maintained over the selected inspiratory time calculated with R Rate and I E I T ratio Inspiration is triggered by patient generated flow for assisted breaths or by the ventilator for controlled breaths breath rate R Rate is the controlling parameter For both controlled and assisted breaths the inspir
3. mbar o Alarms Logs Figure 3 2 Menus in PSV Mode with leakage configuration The ventilation parameters and setting ranges available in PSV mode are listed in Table 3 1 Puritan Bennett 560 Ventilator Clinician s Manual Operating Parameters Table 3 1 Ventilation Parameters in PSV Menu Min Max Adjustment Default Linked Para Value Value Resolution Value meters Standby 2 Standby 55 P Support cmH 0 oe ces 1 15 PEEP mbar or Valve configuration 5 Valve configuration 55 hPa Leak configuration 6 Leak configuration 30 Standby OFF A P an y a 20 1 OFF P Support alve configuration iis Leak configuration 4 ferme te l e sa s a e se er e O o o ae en mwa C a o wo ue sees rs eos Backup R Apnea Time Min I Time Max Time Ls a Refer to chapter 7 Operating Procedures for information on positive and negative E Sens settings Table 3 2 lists the available alarm settings in PSV mode Table 3 2 Alarm Parameters in PSV Mode Adjustment Linked Value Max Value Resolution Default Value Parameters Min VTI 2000 Max VTI Max VTI 3000 Min VTI Min VTE with 1990 Max VTE exhalation valve Max VTE with exhalation valve Min FiO2 Max Leak with i Backup R P Support Pressure Support When Relative Pressure is set to YES in the Setup Menu P Support allows you to determine inspiratory pressure added to PEEP during the inspiratory phase gt I
4. Title line Graphic zone 3 Numeric zone Displays ventilation mode and the Displays the patient s pressure and Displays monitored data following symbols flow waveforms as a function of Battery if the ventilator is time powered by the internal battery For more information refer to x Audio paused 4 if an alarm is chapter 4 Monitored Parameters currently inhibited Alarm paused 4X if an alarm has been cancelled manually and the cause of the alarm remains Apnea Alarm deactivation wR Freeze Waveforms if the tracing of patient waveforms has been halted during ventilation Exhalation valve symbol No exhalation valve x symbol Figure 2 6 Waveforms Menu Puritan Bennett 560 Ventilator Clinician s Manual 2 9 2 11 USB Memory Device Menu USB MEMORY DEVICE 1 Pa InAN 2 gN 40966K0004 E Transfer Continuously OFF 3 O Transfer Trends OFF o Erase Key OFF 4 Figure 2 7 USB Memory Device Menu 1 Title line 3 USB Memory Device Menu 2 Ventilator serial number 4 Dialogue box 2 12 If Ventilator Failure Occurs If a problem with the ventilator is suspected FIRST CHECK THAT THE PATIENT IS NOT IN DANGER If necessary remove the patient from the ventilator and provide an alternate means of ventilation Keep in mind that troubleshooting information is available in this manual to assist you in the event of a problem Refer to chapter 5 Alarms and Troubleshooting
5. If you cannot determine the cause of a problem contact your equipment supplier or Covidien Refer to chapter 10 5 Service Assistance PSV Mode Parameters and Setting Ranges 3 Operating Parameters This chapter describes ventilation and alarm parameters and their setting ranges for each ventilation mode For a listing of operating parameters and monitored patient data refer to Table B 11 on page B 8 For further information about the different ventilation modes and breath types provided by the Puritan Bennett 560 Ventilator refer to Appendix D Modes and Breath Types WARNING If APNEA TIME is set to a value higher than 60 Rate then the APNEA alarm will not activate 3 1 PSV Mode Parameters and Setting Ranges The menus for PSV Pressure Support Ventilation mode are shown in Figure 3 1 and Figure 3 2 PB560C08 a PSV ST o P Support o PEEP o Rise Time o Backup R o Apnea time AUTO oO t Target o Preferences PB560CO8A Support o PEEP o Rise Time m Sens o E Sens O Backup R o Apnea time AUTO oO t Target o Preferences PB560C09 ABS 45 mbar OFF PIP 30 mbar G bpm OFF mbar o Alarms Logs Figure 3 1 Menus in PSV Mode with exhalation valve configuration PB560C09A ABS 15 mbar Ambar P AUTO aelag Current Max i Min PIP met 1491mL F0 mbar Bi eak 0 0Lpm BE iio 0 0L 3 Rate 23bpm Mec 1 21 MA FiO2 OFF
6. Figure 6 1 The Power Cable Holder Puritan Bennett 560 Ventilator Clinician s Manual Connecting to External AC Power To secure the AC power cable 1 Insert the power cable holder Figure 6 2 item 1 into the notch of the battery cover Figure 6 2 Inserting the Power Cable Holder Into the Notch 2 Push the AC power cable into the power cable holder Figure 6 2 item 2 3 Connect the female end of the ventilator s AC power cable to the AC connector on the back of the ventilator W L 1 j i Wee Figure 6 3 Power Cable Connected to the Ventilator 4 Connect the male end of the AC power cable to the AC power outlet e The AC POWER indicator on the top left corner of the ventilator illuminates e The indicator q 4 flashes while the battery charges and then turns off when the battery is fully charged Refer to Figure 6 4 on page 6 4 If the AC power cable becomes disconnected or the AC power source fails an AC POWER DISCONNECTION alarm signals an automatic switch to the external DC power source if the DC power cable is connected or to the ventilator s internal battery One of three power indicators located on the upper left of the ventilator s front panel illuminates to signal which of the three possible power sources are currently in use by the device refer to Figure 6 4 Note The only time the AC POWER and indicators are illuminated at the same time is when th
7. Operating Procedures 2 Put the cursor next to the alarm parameter to be modified using the UP Car or DOWN A v_ key 3 Confirm your intention to modify the parameters using the ENTER G key e The cursor changes to Figure 7 22 item 1 e The parameter in the Min column flashes Figure 7 22 item 2 e Azoom of the min parameter is displayed on the right side of the screen Figure 7 22 item 3 PB560C62 O Alarms Logs Figure 7 22 Modifying Alarm Parameters Min Value 4 Press UP uA or DOWN lt gt to modify the value of the parameter 5 Press ENTER GA to confirm the value selected e The new value for the Min column is continuously displayed Figure 7 23 item 1 e The value of the Max column flashes Figure 7 23 item 2 e Azoom of the Max parameter value is displayed on the right side of the window Figure 7 23 item 3 PB560C62 o Alarms Logs Figure 7 23 Modifying Alarm Parameters Max Value 6 Press UP a or DOWN A vy to modify the value of the parameter 7 Press ENTER GA to confirm the value selected 7 20 Puritan Bennett 560 Ventilator Clinician s Manual USB Menu Parameters e The new value is continuously displayed e The zoom disappears e The cursor returns to normal When an alarm is set to OFF the alarm will not be triggered automatically when its maximum setting limit for the Max value or its minimum setting limit for the Min value is
8. e Loss of memorised parameters Consequence e Locking Key disabled e Out of range settings are replaced by their default values No exhalation valve connected with PEEP set to less than 4 mbar or PIP set to more than 30 mbar when relative pressure is set to OFF The ventilator is delivering apnea ventilation at set back up rate Ventilator cooling fan operating speed not suited to the internal ambient temperature of the device Cut off of the external DC power supply Consequence switch over to the internal battery Failure in the 24 V power supply Detection of a fault in the electrical power supply system Consequence the internal battery capacity is not displayed beside the battery symbol Detection of a fault in internal voltage measurement POST RAM Error RAM Read Write does not match memory setting Puritan Bennett 560 Ventilator Clinician s Manual Alarms and Troubleshooting Table 5 1 Overview of Alarms Continued Alarm Message Cause Ventilator Response POST FLASH Checksum Error Startup FLASH computed checksum does not match memory setting DEVICE FAULT10 RESTART SRVC DEVICE FAULT11 POST EEPROM Error Startup RESTART SRVC EEPROM does not match memory setting DEVICE FAULT12 POST Reference Voltage Error 5V RESTART SRVC or 10V reference voltage error DEVICE FAULT13 Software Version Error RESTART SRVC At least four of the last six spontaneous breaths
9. o Alarms Logs Figure 4 4 Alarm Menu Pressure Leakage Modes CPAP PSV S PSV ST PCV P A C PB560C22 PIP 30 mbar 00 PEEP 3 mbar Mol 0 0L joo IE 1 2 2 PB560C23 o Alarms Logs Figure 4 6 Alarm Menu Volume Modes CV V A C SIMV 4 2 Puritan Bennett 560 Ventilator Clinician s Manual Digital Monitoring PB560C24 Rate Leak 25 0 0 bpm Lpm Figure 4 7 Waveform Menu Pressure Leakage Modes CPAP PSV S PSV ST PCV P A C PB560C25 PB560C26 M Vol 0 0 L Vd 985 mL Rate 131 mL Figure 4 9 Waveform Menu Volume Mode CV V A C SIMV Monitored parameter values are updated every two breath cycles and are displayed in the form of inserts as shown in Figure 4 10 PB560C26A PIP 1 PB560C26 30 i 3 mbar 3 j M vol 0 0 1 Parameter name wi 985 2 mL 15 4 amp FiO2 Ti Te ILE Rate VE S S bpm mL Figure 4 10 Monitored Parameter Inserts Measured or calculated value Unit of measure Puritan Bennett 560 Ventilator Clinician s Manual 4 3 Monitored Parameters 4 4 If the monitored value for a parameter is not applicable or unavailable the value is replaced by a hyphen as shown in Figure 4 11 ae PAC ABS PB560C27 o PIP 15 mbar o PEEP OF o Rise Time 7 2 o Rate 13 bpm o LE 1 2 0 o l Sens 2 ovtTarget OFF e ERRES H eee o Preferences mbar Figure 4 11 Display Showing Unavailable Parameter Values
10. 12 I E I T 3 11 3 15 I Sens 3 3 3 8 3 9 3 12 3 16 3 20 Sens Inspiratory Sensitivity 3 25 Time 3 21 3 26 I O switch figure 7 2 I T IE 3 717 3 15 Ignition sources warning 6 7 Indications for use 2 7 Indicator VENT STDBY 7 2 Indicator and alarm specifications B 3 Indicators AC power 8 4 INTERNAL BATTERY 8 2 8 4 Inhalation port closeup figure 6 9 INSP FLOW alarm message 5 77 5 22 Insp Time 3 20 3 25 Inspiratory Sensitivity 3 12 3 16 3 20 Inspiratory Tidal Volume 3 6 3 8 Inspiratory trigger 4 4 Installation 6 7 placing the ventilator 6 7 Installation and Assembly 6 7 INTENTIONAL VENT STOP alarm message 5 12 5 22 Internal battery charging Warning 6 2 8 4 maintenance none required 10 7 recharging 8 4 replacement interval 70 7 Storing 8 5 test interval 70 7 testing 8 4 F 4 INTERNAL BATTERY indicator 8 4 Involuntary stop test F 4 K Key sound setting of 7 12 Keyboard 2 6 locking of 7 25 unlocking 7 26 KEYPAD FAULT alarm message 5 12 5 22 Keys VENTILATION ON OFF 7 2 L Labels 7 13 Linked ventilation parameters setting 7 19 Liquids avoid ingress into ventilator Warning 7 3 Locking key disabling 7 26 enabling 7 26 Locking Key and SETUP menu 7 3 Locking the keyboard 7 25 Logs menu alarms 5 3 LOW BATTERY alarm message 7 4 5 12 5 22 8 3 LOW FIO2 alarm message 5 12 5 22 Low pressure test F 7 LOW VTE alarm
11. Alarm activation occurs if conditions remain for the maximum time between e disconnection time and 60 R Rate in PA C and V A C mode disconnection time and Apnea time 2 sec in CPAP and PSV mode disconnection time and PATIENT 60 R Rate Insp time in DISCONNECTION P SIMV and V SIMV mode HP Yes No IF PERSISTS If the flow is greater than RESTART SRVC 130 lpm during the inspiratory phase In VA C and V SIMV modes if patient pressure is lower than Min PIP In PSV CPAP P A C modes and P SIMV if patient pressure is lower than P Support PEEP 20 or P Control PEEP 20 Detection of a fault in the POWER FAULT i electrical power supply system 1 Electrical power supply to the machine is interrupted with the I O switch when ventilation is in progress or 2 Battery fully discharged when POWER SUPPLY LOSS i it ies the es source of power VHP No Yes no message to the ventilator Consequence ventilation stops immediately Ventilation restarts immediately when the switch is pressed in case 1 above or after restoration of the AC or DC supply in case 2 above Faulty internal pressure sensor PRES SENS FLT1 signal RESTART SRVC Alarm activation occurs HP Yes No e After 15 seconds Faulty proximal pressure sensor PROX SENS FLT2 signal RESTART SRVC Alarm activation occurs MP yes Yes e After 15 seconds The ventilation settings are not REMOVE VALVE compatible with the type of CPAP MODE pat
12. cece cece eee eee 7 8 7 3 Preferences Menu Parameters c cece cece eee eees 7 8 7 3 1 Preferences Menu ccc ccc cece eee e eee ees 7 9 32 Backi ouss ous venu sche ecunawstaoaeerdeutenads 7 10 Too LONE ea ER TEREE ERER ss 7 11 7 3 4 Alarm VOlIUMe 0 cc ccc ccc cece eee eees 7 11 Poe Ky SOUN ese o ceca R 7 12 7 3 6 Intentional Vent Stop Alarm 00 eee 7 12 7 3 7 Apnea Alarm lt 65s uscnevacsscsewadeaeanseeun aden 7 12 7 3 8 Disconnection Alarm 0c ccc cee eee ees 7 13 7 3 9 Waveforms Display cece cece eeee 7 13 7 3 10 Pediatric Circuit oe socicndepreensendavaaereenedies 7 14 7 3 11 Ventilation REport ccc cc ccc eee eee ees 7 14 74 Setting the Ventilation Mode cc eee cece 7 14 7 4 1 Changing Modes While Ventilation is on Standby 7 15 Puritan Bennett 560 Ventilator Clinician s Manual 10 7 4 2 Changing Modes During Ventilation 7 16 7 5 Setting Ventilation Parameters cece eee eee 7 18 7 5 1 Links between Ventilation Parameters 7 19 7 5 2 Links between Ventilation and Alarm Parameters 7 19 7 6 Setting Alarm Parameters c cece cece ee eeeeee 7 19 7 7 USB Menu Parameters lt 6 lt cscdeevers toveestascreeneeseans 7 21 7 7 1 USB Memory Device Specifications 7 22 F MOO WOU eeir ri eer TE 7 22 7 7 3 Transfer Continuously cc cece eee eee 7 22 7 7 4 Tran
13. or DOWN v_ to set the message to YES Setting the ventilator to NO configures the device for an Adult circuit 4 Press ENTER GA Note The default setting is NO the ventilator is set for Adult use 7 3 11 Ventilation Report Accessing the Ventilation Report 1 Use the UP 245 or DOWN 6 v_ arrows to place the cursor at the Ventilation Report position 2 Press ENTER GA PB560C33 VENTILATION REPORT vent Time 8h O min on 27 APR 2007 Machine 00042h Patient 00009 45min m Back Figure 7 14 Accessing the Ventilation Report Note The menu is displayed for five minutes then screen reverts to the Preferences Menu To exit the Ventilation report 1 Press ENTER GW Setting the Ventilation Mode The ventilation mode can be changed from the ventilation parameters menu or the alarm parameters menu as long as the Locking Key is not enabled refer to section 7 8 Locking the Control Panel on page 7 25 and section 7 9 Unlocking the Control Panel on page 7 26 Puritan Bennett 560 Ventilator Clinician s Manual Setting the Ventilation Mode The procedure to change the ventilation mode depends on the ventilation status as described in section 7 4 1 and section 7 4 2 A N WARNING In the SIMV mode the use of a double limb circuit is recommended The VTE Min setting should remain active in the event that pressure losses are present on the patient circuit downstream from the
14. 41 17865010 Puritan Bennett 560 Ventilator Clinician s Manual Covidien Italia S p A Via Rivoltana 2 D 20090 Segrate Italy Tel 39 027 031 72 61 Fax 39 027 031 72 84 Covidien Nederland BV Hogeweg 105 5301 LL Zaltbommel Nederland Tel 31 41 857 66 68 Fax 31 41 857 67 96 Covidien Polska Al Jerozolimskie 162 Warszawa 02 342 Polska Tel 48 223 122 130 Fax 48 223 122 020 Covidien Russia 53 bld 5 Dubininskaya Street Moscow RUSSIA 119054 Poccun Tel 70 495 933 64 69 Fax 70 495 933 64 68 Covidien Spain S L c Fructuos Gelabert 6 pl S tano 08970 Sant Joan Despi Barcelona Spain Tel 34 93 475 86 69 Fax 34 93 373 87 10 Covidien UK amp Ireland Unit 2 Talisman Business Park London Road Bicester OX26 6HR United Kingdom Tel 44 0 1869 328092 Fax 44 0 1869 327585 Covidien Japan Inc Technical Support Center 83 1 Takashimadaira 1 Chome Itabashi ku Tokyo 175 0082 Japan Tel 81 0 3 6859 0120 Fax 81 0 3 6859 0142 Covidien Norge AS Postboks 343 1372 Asker Norway Tel 47 668 522 22 Fax 47 668 522 23 Covidien Portugal Lda Estrada do Outeiro de Polima Lote 10 1 Ab boda 2785 521 S Domingos de Rana Portugal Tel 35 121 448 10 36 Fax 35 121 445 1082 Covidien Saglik A S Maslak Mahallesi Bilim Sokak No 5 Sun Plaza Kat 2 3 Sisli Istanbul 34398 Turkey Tel 90 212 366 20 00 Fax 90 212 276 35 25 Covidien Sverige AB Box 54 171 74 Solna Sw
15. 560 Ventilator Clinician s Manual Specifications Table B 22 Electromagnetic Immunity Conducted and Radiated RF The ventilator is intended for use in the electromagnetic environment specified below The customer or the user of the ventilator should assure that it is used in such an environment IEC EN 60601 1 2 Test Electromagnetic Environment Immunity Test Level Compliance Level Guidance Portable and mobile RF communica tions equipment should be used no closer to any part of the ventilator including cables than the recom mended separation distance calculated from the equation applicable to the fre quency of the transmitter Recommended separation distance Conducted RF 3 Vrms 3 Vrms IEC EN 61000 4 6 150 kHz to 80 MHz outside 150 kHz to 80 MHz outside d 0 35 P ISM bands ISM bands 10 Vrms 10 Vrms inside ISM bands inside ISM bands Radiated RF 10 V m 80 MHz to 2 5 GHz 10 V m 80 MHz to 2 5 GHz IEC EN 61000 4 3 d 1 2 P80 MHz to 800 MHz d 2 3VP 800 MHz to 2 5 GHz where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufac turer and d is the recommended sepa ration distance in metres m P Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol
16. Cleaning the Exhalation Block The exhalation block should be changed every 4 months and cannot be reused with any other patient Ensure that the exhalation block is completely dried after cleaning and prior to use Puritan Bennett 560 Ventilator Clinician s Manual 1 7 Safety Information 1 8 When an exhalation block is set up each time it is removed or after installing a new exhalation block on the machine it is essential that the exhalation flow sensor be recalibrated before the exhalation block is used Refer to section 10 1 Calibrating the Exhalation Flow Sensor The patient circuit is intended for single use by a single patient D and should be changed according to the manufacturer s recommendations and according to the patient circuit lifetime Refer to the instructions for use supplied by the manufacturer of the patient circuit included with the ventilator and chapter 6 Installation and Assembly A patient treated by mechanical ventilation is highly vulnerable to the risks of infection Dirty or contaminated equipment is a potential source of infection Clean the ventilator and its accessories regularly and systematically before and after each use and following any maintenance procedure to reduce the risks of infection The use of a bacterial filter at the ventilator s outlet or both ports if a double limb circuit is used is recommended Refer to chapter 9 Cleaning Regularly check the cleanli
17. Inspiratory Trigger During each inspiration phase triggered by the patient the Inspiratory Effort Detected symbol is displayed beside the cycling I E ratio in the ventilation alarm or waveform menus see Figure 4 12 The patient triggers the ventilator by inhaling the amount of flow and the ventilator responds by delivering either a pressure based or volume based breath PB560C28 PB560C29 a PAC ABS oP AIC i monet f min c urrent Max i o PEEP OF an nee PP 30 mbar o Rise Time 72 1 70 i eee 975 FALI PEEP 3 mbar o Rate 13bpm o LE 4 2 0 3 nem 300 2 000 aO o Sens 2 pi ovtTarget OFF o Rtot bpm OFIO2 o Preferences mbar o Alarms Logs Figure 4 12 Inspiratory Effort Detected Indicator Displayed Monitored Parameters Table 4 1 Displayed Monitored Parameters Patient exhaled flow is measured by the exhalation Exhaled Tidal Volume 20 to 9999 ml flow transducer and that measurement is used to calculate volume the flow transducers do not directly measure volume The displayed value is updated at each inspiration but is available only in the double limb patient circuit configuration Exhalation ti Exhalation Time E Time 0 to 59 9 ana EO Eear The displayed value waveform only is updated at each inspiration P t f inspired by the patient Fraction of Inspired FIO2 0 to 99 ap Bu ie ore Ba Ox The displayed value waveform only is updated at ygen ie ae each inspiration Purita
18. Modify the Max VTI level Note Always consult the clinician before changing PEEP FIO3 pressure volume or Rate settings Modify the pressure level A leak in the patient circuit causing Check and properly connect the patient increased bias flow circuit Inappropriate patient circuit Replace the patient circuit Have a qualified technician replace the defective component s and call your customer service representative Note Always consult the clinician before changing PEEP FIO3 pressure volume or Rate settings Increase the Max PIP threshold Defective flow sensor or internal leak in the machine Adjustment of Max PIP too low only for V A C and V SIMV modes Check patient s trachea and clear the obstruction If the filter is obstructed replace the filter Proximal pressure tube or patient circuit Clean the proximal pressure tube or the obstructed patient circuit or replace them Airway obstruction HIGH PRESSURE Coughing or other high flow exhalation Treat patient s cough efforts Silence the alarm if necessary Patient inspiratory resistance or Have physician determine if ventilator compliance changes settings are appropriate for the patient Defective internal circuits of the machine or Replace the ventilator and call your pressure sensor customer service representative 5 21 Puritan Bennett 560 Ventilator Clinician s Manual Alarms and Troubleshooting Table 5 2 Alarms and
19. Rate 3 25 Rise Time 3 26 Volume Control Vt 3 24 VT Target Target Tidal Volume 3 5 Parts and accessories H 1 Patient outlet port connections figure 6 9 Patient circuit 6 6 attaching to ventilator 6 6 choosing 6 6 double limb connecting 6 7 installing 6 6 length and internal volume 6 10 replacement interval 10 6 single limb connecting 6 7 6 9 Patient counter 7 2 PATIENT DISCONNECTION alarm message 5 13 5 24 Patient hours changing the setting of 7 6 Patient Caregiver Checklist A 7 Patients vi targeted for use of ventilator 2 7 Peak inspiratory flow 3 4 3 21 Peak inspiratory pressure 3 10 PEEP 3 3 3 8 3 11 3 15 3 19 3 24 Performance specifications B 3 Physical specifications B 7 PIP 3 10 3 16 3 27 Placing the ventilator installing 6 7 Pneumatic specifications B 9 Positive end expiratory pressure 3 77 Power failure test F 2 POWER FAULT alarm message 5 13 5 24 Power On Self Test POST 7 2 POWER SUPPLY LOSS alarm message 5 13 5 24 Precautions for use electromagnetic interference 7 70 Precautions for use cautions general 7 10 installation environment 7 70 maintenance 7 10 Precautions for use warnings general 7 7 installation electrical power supplies 7 3 maintenance 7 10 oxygen 7 70 settings 7 70 Preference menu changing the settings in 7 9 displaying 7 9 7 22 PRES SENS FLT1 alarm message 5 13 5 24 Pressu
20. a When set to YES Sigh Vt and Sigh Rate are displayed A Sigh Rate of 50 means a sigh is delivered every 50 breaths Rate Min VTE Max VTE Vt Sigh Min PIP Max PIP The alarm parameters adjustable in V A C mode are as follows Table 3 8 V A C Mode Alarm Parameters Min Max Adjustment Default Value Value Resolution Value Linked Parameters Min PIP cmH 0 mbar 2 52 PEEP or hPa Max PIP 12 PEEP Min PIP Max PIP cmH 0 mbar or hPa 3 14 Puritan Bennett 560 Ventilator Clinician s Manual V A C Mode Parameters and Setting Ranges Table 3 8 V A C Mode Alarm Parameters Continued Min Max Adjustment Default Value Value Resolution Value Linked Parameters Vt VOLUME CONTROL Vt allows you to set the tidal volume to be delivered to the patient at each inspiratory phase For physiological and safety reasons the Vt setting is limited by the settings of Insp Time and Rate The ratio of Vt to Insp Time Vt Insp Time is 3 lt Vt x 60 Insp Time x 1000 lt 100 A WARNING Ensure that the patient circuit is appropriate for the tidal volume setting tube 22 mm for adults and 15 mm for pediatric tidal volumes lower than 200 ml PEEP POSITIVE END EXPIRATORY PRESSURE PEEP allows you to determine the level of pressure maintained during the exhalation phase The ventilation mode can be adjusted without PEEP PEEP is nearly 0 mbar when set to OFF Ramp Pattern FLOW SHAPE This parameter is
21. gt B 12 Puritan Bennett 560 Ventilator Clinician s Manual Specifications Table B 22 Electromagnetic Immunity Conducted and Radiated RF Continued Note e At 80 MHz and 800 MHz the higher frequency range applies e These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a The ISM industrial scientific and medical bands between 150 kHz and 80 MHz are 6 765 MHz to 6 795 MHz 13 553 MHz to 13 567 MHz 26 957 MHz to 27 283 MHz and 40 66 MHz to 40 70 MHz P The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2 5 GHz are intended to decrease the likelihood that mobile portable communications equipment could cause interference if it is inadvertently brought into patient areas For this reason an additional factor of 10 3 is used in calculating the recommended separation distance for transmitters in these frequency ranges Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the ventilator is used exceeds the
22. however all active messages are displayed in the sequence in which they occurred Puritan Bennett 560 Ventilator Clinician s Manual Alarms and Troubleshooting 5 3 Alarm Logs Menu All alarms are recorded in the internal memory of the ventilator at the time they are activated The Alarm Logs menu is used to display the last eight 8 alarms activated along with their date and time of activation To access the Alarm Logs menu do the following 1 Press the MENU EH key to access the alarm setting menu if this is not the menu currently displayed 2 Press the DOWN 6 key several times or press until the cursor is on the Alarm Logs line at the bottom of the page The display appears as follows o PC P A C TO START AC POWER DISCONNECTION m Alarms Logs PB560C36 Figure 5 2 Accessing Alarm Logs Menu 1 Press the ENTER WY key The Alarm Logs screen is displayed ALARM LOGS peace AC POWER DISCONNECTION 01 jAN 09 12 05 am gw User s clear alerts o Back Figure 5 3 Displaying the Alarm Logs Screen Note When no alarm has been activated NO DATA is displayed on the screen see graphic below ALARM LOGS PB560C43 gw User s clear alerts o Back Figure 5 4 Alarm Logs Display when No Alarm Activated 5 3 Puritan Bennett 560 Ventilator Clinician s Manual Alarms and Troubleshooting 5 4 5 4 For more information on the USER S CLEAR ALERTS line r
23. maximum VTE alarm parameters must be properly set to warn in the event of patient disconnection Puritan Bennett 560 Ventilator Clinician s Manual Warnings e Failing to replace a dirty air inlet filter or operating the ventilator without a filter may cause serious damage to the ventilator e Before cleaning the ventilator first disconnect the ventilator and the patient circuit e Ifthe ventilator is used indoors the condition of the air inlet filter should be checked monthly If the ventilator is used outdoors or in a dusty environment the filter should be checked weekly and replaced as necessary e The air inlet filter is not reusable do not attempt to wash clean or reuse it e The patient circuit should always be positioned to avoid hindering the patient s movements to prevent accidental disconnection or leakage and to minimise the risk of patient strangulation e For pediatric use ensure that the patient circuit type fits and in all respects is suitable for use witha child Use a pediatric circuit for patients that weigh under 53 Ib 23 kg To ensure proper performance of the ventilator See Table H 2 List of Circuits on page H 2 for a list of recommended patient circuits e Resistance of the exhalation valve and accessories water traps filters HMEs etc must be as low as possible e Adding attachments to the ventilator breathing system can cause the pressure during exhalation at the patient connection port
24. power source cut off Cancel the alarm then check the power AC POWER cable availability of a voltage on the AC DISCONNECTION power mains outlet Starting with 12 30 VDC external power Cancelthealarm supply Current limiting fuse of the device blown RepiacE mG venata A eal OENE maintenance technician Ensure the patient is breathing and adjust the inspiratory setting appropriately based on patient s respiratory needs Patient s breathing effort less than the Sensitivity control setting Examine the patient for breathing effort and stimulate if necessary Patient apnea If patient status has changed adjust the ventilator settings based on patient s respiratory needs Have a qualified technician replace the Defective sensors defective component s and call your customer service representative Restart ventilator to see if alarm clears If not replace the ventilator and call your customer service representative Puritan Bennett 560 Ventilator Clinician s Manual Alarms and Troubleshooting Table 5 2 Alarms and Corrective Actions Continued Alarm Message or Possible Reason s For The Alarm Event Corrective Action s Symptom BATTERY FAULT2 a RESTART SRVC Internal battery missing or not detected Defective operation of the buzzers BUZZER FAULT1 RESTART SRVC Consequence no audible tone when an alarm is activated Internal technical problem that prevents the very high priority POWER SUPPL
25. representative NO PROXIMAL LINE2 The proximal pressure line is disconnected Connect proximal pressure line LOW VTI Defective flow sensor or internal leak in the machine 5 23 Puritan Bennett 560 Ventilator Clinician s Manual Alarms and Troubleshooting Table 5 2 Alarms and Corrective Actions Continued plate Messagen Possible Reason s For The Alarm Event Corrective Action s Symptom Adjustment of Min PIP too high Decrease the Min PIP threshold Leak or loose connection in the patient Check the patient circuit connections to circuit the ventilator examine all connections for leakage and tightness PATIENT Circuit disconnection from patient or DISCONNECTION ventilator Replace the patient circuit if necessary EE S AITEN Check Min PIP alarm setting nspiratory flow exceeds IF PERSISTS i Adjust Apnea alarm setting RESTART SRVC Plas ae Inappropriate patient circuit Replace the patient circuit Restart ventilator to see if alarm clears If Defective internal circuits of the machine or not have a qualified technician replace pressure sensor the defective component s or call your customer service representative OCCLUSION CHECK CIRCUIT Clean unblock and or properly connect Patient circuit obstructed the patient circuit IF PERSISTS RESTART SRVC The built in LEAK in the mask may be OCCLUSION obstructed CHECK CIRCUIT The built in leak for the mask is not sufficient for the
26. s oxygen connector s locking stud item 4 retracts the ventilator s oxygen connector s locking tab item 5 is released ensuring that the oxygen connection is locked and secured in place tl 5 Figure 6 16 Connecting the Oxygen Supply System Installation and Assembly To disconnect the oxygen supply system from the ventilator Note Ensure the oxygen source is turned off prior to placing the ventilator in Standby or turning off the ventilator 1 Stop the oxygen flow from the oxygen supply 2 Press the locking tab of the ventilator s oxygen connector as shown in Figure 6 17 to unlock the oxygen connection Figure 6 17 Disconnecting the Oxygen Supply System 3 Disconnect the oxygen supply s oxygen connector by pulling it towards you The ventilator s oxygen connector s locking stud Figure 6 16 item 4 will then extend outwards which is required before the oxygen connector can be reconnected WARNING The coupler must not remain connected to the oxygen connector unless it also connected to a leak proof external oxygen gas source When an oxygen supply is not being used with the ventilator disconnect the oxygen source completely from the ventilator In the event of an oxygen leak shut down the supply of oxygen at its source In addition remove and or keep any incandescent source away from the device which may be enriched with oxygen Circulate fresh air into the room to bring the oxygen level
27. the rear of the ventilator I O Leave to charge for at least 15 minutes An FiO sensor is detected and has not CALIBRATE FIO2 Bde calibrated Calibrate FiO sensor Too large a difference between a calibration point and its tolerance range CALIBRATION FAIL Exhalation block defective or not properly aligned Defective exhalation flow sensor CHECK BATTERY CHARGE Battery charging impossible Incorrect circuit type selected in the Preferences menu Restart calibration There may be a leak in the circuit Ensure an approved circuit is in use refer to circuit documentation Verify the circuit selection in the Preferences matches the circuit in use Reset alarm message and ensure all connections are secure verify circuit integrity and verify the exhalation block is properly seated Have a qualified technician replace the defective component s and call your customer service representative Do not disconnect the ventilator from the AC power supply Ensure that the power cable is installed according to the instructions in chapter 6 Installation and Assembly so that the power cable cannot be involuntarily disconnected In the event the internal battery capacity is low use an alternate device to ventilate the patient Call your customer service representative Puritan Bennett 560 Ventilator Clinician s Manual Alarms and Troubleshooting Table 5 2 Alarms and Corrective Action
28. the ventilator can be expected to operate on internal battery power for the average durations shown in Table 8 1 Checking the battery charge level requires that the ventilator be running on battery power at the time of the battery check To check the battery charge level temporarily disconnect the ventilator from AC power while in Stand By mode or while providing ventilation and read the percent charge level displayed adjacent to the battery icon displayed at the top of the ventilator s display screen Table 8 1 Internal Battery Reserve Capacity Displayed Values Average Operating Time on Internal Battery Power Vt 200 ml 5 ml PIP 10 mbar 2 mbar 11 hours 10 Rtot 20 bpm Vt 300ml 5 ml PIP 20 mbar 2 mbar 9 hours 10 Rtot 15 bpm Puritan Bennett 560 Ventilator Clinician s Manual 8 1 Internal Battery Table 8 1 Internal Battery Reserve Capacity Continued Displayed Values Average Operating Time on Internal Battery Power Vt 500 ml 5 ml PIP 30 mbar 2 mbar 6 5 hours 10 Rtot 15 bpm Vt 750 ml 5 ml PIP 45 mbar 2 mbar Rtot 20 bpm Maximum Ventilation Parameters 4 5 hours 10 a Average durations shown are with a fully charged battery having less than 50 charge recharge cycles 8 2 Battery Operation A N WARNING Before using the ventilator s internal battery ensure that the battery is fully charged and that the charge holds Back
29. visit the SolvIT Center Knowledge Base by clicking the link at http www puritanbennett com or contact you customer representative 6 4 2 Installing the Patient Circuit The patient circuit is mounted depending on the setup of the circuit used and the accessories used Puritan Bennett 560 Ventilator Clinician s Manual Patient Circuit The following procedures describe the installation of the patient circuit with a humidifier To add other accessories refer to the installation instructions for the specific accessories used To connect a single limb circuit with an exhalation valve refer to Figure 6 7 1 Hi S O Inspect the components of the patient circuit for any signs of damage such as cracks which might cause leakage Do not use damaged components to assemble the patient circuit yz Install the bacteria filter item 1 on the TO PATIENT outlet port as shown Attach one end of the short circuit tubing item 2 to the bacteria filter item 1 Attach the other end of the circuit tubing item 2 to the inlet port of the humidifier item 3 Place a water trap item 4 between the outlet port of the humidifier and the inlet of the exhalation valve item 5 Ensure the exhalation valve item 5 is placed as close as possible to the patient Connect one end of the proximal pressure tubing item 7 to the proximal pressure port on the exhalation valve item 5 and the other end onto the ventilator patient pressur
30. 1 PSV Mode Parameters and Setting Ranges 3 1 3 2 CPAP Mode Parameters and Setting Ranges 3 7 3 3 P A C Mode Parameters and Setting Ranges 3 9 3 4 V A C Mode Parameters and Setting Ranges 3 14 3 5 P SIMV Mode Parameters and Setting Ranges 3 18 3 6 VSIMV Mode Parameters and Setting Ranges 3 23 3 7 FiO2 For Various Oxygen and Ventilator Settings 3 29 4 Monitored Parameters ccccccccccccccccccccccccececs 4 1 4 1 Digital Monitoring sssssnssnsssrsssssnessesseeses 4 1 4 2 Bargraph Display snnnnsnnsunsnnsesnnsoesosreseese 4 5 4 3 Waveform Display 0 cc ccc ccc cece cent eens 4 6 44 Ventilation Report ccc ccc ccc cece eee eees 4 7 5 Alarms and Troubleshooting ccccccccccccccececes 5 1 5 1 Alarm Level of Priority tso vasdccsove orev eddagaadeerneoer lt s 5 1 5 2 Alarm Display ccc ccc ccc ccc cc ccc ee eee ee ees 5 2 Puritan Bennett 560 Ventilator Clinician s Manual 5 3 Alarm Logs Menu ja cnedu onde x iowmaeen enema pe cunie sesame 5 3 5 4 Silencing the Audible Portion of Alarms 5 4 5 5 Pausing Resetting AlarMms ccc cece cece eee eees 5 5 5 6 Re activating Alarms ccc ccc ccc cece eee eeeneees 5 5 5 7 Overview of Alarms 0 ccc ccc ccc cece e eee e ee eeees 5 7 5 8 IPOWVDICSNOOUNG yivorn 59550 kewwnds tweets deus eeeores 5 15 DO PAWNS assasme
31. 10 Table 3 11 Table 3 12 Table 4 1 Table 5 1 Table 5 2 Table 5 3 Table 7 1 Table 7 2 Table 8 1 Table 9 1 Table 10 1 Table A 1 Table B 1 Table B 2 Table B 3 Table B 4 Table B 5 Table B 6 Table B 7 Table B 8 Table B 9 Table B 10 Table B 11 Table B 12 Table B 13 Table B 14 Table B 15 Table B 16 Table B 17 Table B 18 Table B 19 Table B 20 Ventilator SYM OIS ses cccccececeaveteieeuyendotesensdete beecwndasasinteawedueeien 1 10 Ventilator Labels and MarkingS cc ccc ccc cece eee e eee e ee eeeeeeeeennnes 1 14 Ventilation Parameters in PSV M nu ccc ccc eee eee cece eee e eee eneneeees 3 2 Alarm Parameters in PSV Mode ccc ccc cece cece eee e eee e seen eeeaeeeeens 3 2 Ventilation Parameters in CPAP Menu ccc cece cece eee e eee e eee eeaeees 3 7 Alarm Parameters in CPAP Mode 4 44404 carte sis yee ene eae eReose ses seaewess 3 7 Ventilation Parameters in P A C Mode Menu c cece eee ee cence eeeeeeees 3 10 Alarm Parameters in P A C Mode ccc cece cece cece eect eee e eee eeneeeeeees 3 10 Ventilation Parameters in V A C Ventilation Mode cece cece eee e ees 3 14 V A C Mode Alarm Parameters iss 650s4444 24 604040 14 sesso erties erased ovesewswaes 3 14 Ventilation Parameters in P SIMV Ventilation Mode 00 cece eee eee eeees 3 18 Alarm Parameters in P SIMV Ventilation Mode cc cc cece cece eee eee
32. 10 8 Patient Caregiver Checklist cccccccccccccsceccces A 1 Specifications sivecaevaeeotussaeestrerGheretenvsaesennnes B 1 B 1 PHYSIC ceap EEEE EEES EE sone setgerneneseeesines B 1 B 2 PICCTIICAL ean raa aE E EE panmneN aa EEES B 1 B 3 Indicators and AlalinGei os nck wngpecansagowe veeeeden eens B 3 B4 Performance sesissisrriitenrecede reitir ti n tare B 3 B 4 1 Specifications icis0cdcbecnsteescsanddadieeesaewes B 3 B 5 Monitored Parameters ccc ccc ccc cee eee eeeee D 3 B 6 Range Resolution and ACCUracy cece cece neces B 5 B 7 Environmental dusacves oucuanoneetetwanneetereeeaaeaese B 8 Puritan Bennett 560 Ventilator Clinician s Manual DS WOR oee es eeaannee row aneusueaunteeueaeaneu ans B 8 B 9 PHCUINGUG o4 0dqae Gadakeee otiwactae oreauseseworecdsecaeecn B 9 B 10 Manufacturer s Declaration 00 ccc cece eee ee eee B 9 B 11 Standards Compliance and IEC Classification B 14 Theory Of Operation cccccccccccccccccccccscscssceces C 1 C 1 APC ITC CIN tara anive on se ceeearwneeerecneuearss seve resees C 1 C 2 ODEI Ol seers ho edaue 4 hes eae eeadieoseeeyeecesagosus C 1 Modes and Breath Types ccccccccccccccccccccccecs D 1 D 1 Modes of Ventilation 0 e ee eee eees D 1 D 1 1 Assist Control A C Modes 0 cece D 1 D 1 2 SIMV I MOOCS ones oduaseasaeer eas necaseweanauans D 1 D13 CRAP MOQE eos cecknss aveoosseshasdasieeesenhaeee D 1 D14 PSY MOG
33. 2 6 item 7 This key is used to access the ventilator s menus via the ventilator s front panel LCD display This symbol IEC 60417 5009 appears on the ventilator s front panel VENTILATION ON OFF button see Figure 2 3 on page 2 6 item 8 This key is used to Start and Stop ventilation To patient port This symbol appears on the front right of the ventilator adjacent to the To Patient port see Figure 1 1 on page 1 15 item 1 From patient port double limb option This symbol appears on the front left of the ventilator adjacent to the From Patient port see Figure 1 1 on page 1 15 item 4 Patient proximal pressure port This symbol appears on the front right of the ventilator adjacent to the From Patient port see Figure 1 1 on page 1 15 and Figure 1 4 on page 1 17 item 3 Exhalation valve pilot port This symbol appears on the front right of the ventilator adjacent to the To Patient port indicating the connection of the tubing between the patient circuit exhalation valve see Figure 1 1 on page 1 15 and Figure 1 4 on page 1 17 item 3 Oxygen inlet This marking appears on the back panel of the ventilator adjacent to the oxygen inlet port see Figure 1 3 on page 1 16 item 2 Nurse Call connector This symbol appears on the back panel of the ventilator adjacent to the nurse call connector see Figure 1 3 on page 1 16 item 2 Switch in Off position IEC 60417 5008 This symbol appears on the I O power
34. 4 e The confirmation line Accept Mode YES is displayed on the bottom left figure below item 5 PB560C5 1 Eo a V AIC INACTIVE IPAC ACTIVE 2 y 500m Ma OFF Prea B k 1428 mL 3 gt o Rate 13bpm f Rate 10bpm ie i LE 4 2 0 lt 4 2 ie Fi02 21 OFF MA Vol 0 0L 5 c gt YES Figure 7 17 Changing Ventilation Modes During Ventilation 2 7 16 Puritan Bennett 560 Ventilator Clinician s Manual Setting the Ventilation Mode The Alarm menu screen is shown below that shows the same active and inactive mode information being displayed along with the Accept Mode Yes line alarm parameter settings and patient values PB560C58 m V A C INACTIVE Vil 96 mL PEEP 3 mbar vol 0 0L 1 2 3 Figure 7 18 Changing Ventilation Modes During Ventilation 3 5 Change the settings of the new mode including alarms if necessary 6 Press DOWN 6 to place the cursor on the Accept Mode YES line 7 Press ENTER G to confirm the mode change e The new mode selected is displayed with its settings It is applied at the beginning of the next exhalation phase if it occurs during inspiration or immediately if it occurs during exhalation It is not mandatory to change modes during ventilation see steps 6 and 7 above The settings of the next INACTIVE mode can be prepared while ventilation is in progress in the current ACTIVE mode The modifications will b
35. 78 PSV Mode Menu 3 2 V A C Mode Menu 3 14 V SIMV Mode Menu 3 24 Alarm tests Apnea test F 7 Involuntary stop test F 4 Alarm thresholds and linked Ventilation parameters 7 19 Alarms Calibration Fail 70 3 display of 5 2 Level of priority 5 7 Logs menu 5 3 menu 2 8 NO DATA message 5 3 overview of 5 7 re activating 5 5 resetting 5 5 setting parameters 7 19 silencing 5 4 tests F 7 thresholds blocking when linked to a ventilation pa rameter 7 21 Troubleshooting 5 75 volume setting of 7 11 Alarms and troubleshooting 5 7 Alarms tests continuing pressure F 2 high pressure F 3 low pressure F 7 power failure F 2 Alarms utilisation 5 7 Alarms ventilation 5 7 Altitude compensation feature C 7 Antibacterial filter 6 11 Apnea and Backup Rate 3 25 3 26 and ventilation modes D 6 APNEA alarm message 5 7 5 15 Apnea alarm test F 7 Apnea Time 3 4 3 8 3 20 3 26 Audible alarms silencing 5 4 Back panel 2 5 Backlight display setting of 7 10 Backup R 3 4 Backup Rate and R Rate setting 3 24 3 25 Bar chart pressure 4 7 Bargraph display 4 5 Battery heat safety device 1 4 6 2 BATTERY FAULT1 alarm message 5 7 5 15 8 4 BATTERY FAULT2 alarm message 5 7 5 16 Battery internal Capacity 8 7 indicator front panel figure 8 2 operation 8 2 reserve capacity display ventilation running figure 8 3 reserve capacity
36. 8 The setting of the Min PIP alarm must be adjusted for the patient but must also be set high enough to allow the PATIENT DISCONNECTION alarm to trigger properly Perform the Low Pressure Test refer to section F 1 Low Pressure Test on page F 1 to ensure the Min PIP alarm is properly set Note Most of these tests require that an approved patient circuit be connected to the ventilator Ensure that your patient circuit is properly connected prior to performing these tests F 1 Low Pressure Test WARNING The setting of the Min PIP alarm must be adjusted for the patient but must also be set high enough to allow the PATIENT DISCONNECTION alarm to trigger properly Perform the following test to ensure the Low PIP alarm is properly set 1 Before proceeding set the ventilation and alarm parameters specified by the patient s clinician and specify a single or dual circuit setup 2 Press the VENTILATION ON OFF key to start ventilation Keep the patient s end of the breathing circuit open and allow ventilation to continue 4 Wait for Apnea Time 2 seconds Apnea time is not always 5 seconds then ensure that e the High priority indicator red colour lights up e the PATIENT DISCONNECTION alarm is displayed e the audible alarm sounds 5 Press the ALARM CONTROL key once to silence the alarm 6 Press the VENTILATION ON OFF key for three 3 seconds then release it The ventilator will switch to Standby mode and
37. BF Applied Parts e IP31 with respect with respect to access to hazardous parts and ingress of moisture e Not suitable for use in the presence of flammable anesthetic mixtures e Not suitable for sterilisation e Suitable for continuous operation e Detachable power supply cable e Supplement No 1 94 to CAN CSA C22 2 No 601 1 M90 Medical Electrical Equipment Part 1 General Requirements for Safety e UL60601 1 Medical Electrical Equipment Part 1 General Requirements for Safety 2003 Collateral Standards e Medical Electrical Equipment Part 1 General Requirements for Safety 2 Collateral standard Electro Magnetic Compatibility requirements and tests IEC 60601 1 2 2007 and EN 60601 1 2 2007 e Medical Electrical Equipment Part 1 General Requirements for Safety 2 Collateral standard Programmable Electrical Medical Systems IEC 60601 1 4 2000 and EN 60601 1 4 2004 e Medical Electrical Equipment Part 1 General Requirements for Safety 2 Collateral standard Usability IEC 60601 1 6 2006 and EN 60601 1 6 2007 B 14 Puritan Bennett 560 Ventilator Clinician s Manual Standards Compliance and IEC Classification General Requirements tests and guidance for alarm systems in medical electrical equipment and medical electrical systems IEC 60601 1 8 2003 and EN 60601 1 8 2007 Particular Standards Lung Ventilators for Medical Use Particular Requirements for Basic Safety and Essential Performance Part 2 Home Care Vent
38. Corrective Actions Continued Alarm Message or Possible Reason s For The Alarm Event Corrective Action s Symptom Adjustment of the Max Rtot level too low Re adjust Max Rtot Adjustment of the Sens level too low Adjust Sens according to the patient HIGH RATE INSP FLOW RESTART SRVC INTENTIONAL VENT STOP KEYPAD FAULT RESTART SRVC LOW BATTERY LOW FIO2 5 22 Patient hyperventilating Defective inspiratory flow sensor Inspiratory flow is constant 1 lpm with normal turbine temperature and speed conditions The user caregiver has stopped ventilation by holding down the VENTILATION ON OFF key for three 3 seconds by and ventilation is in stand by Pressing a key for more than 45 seconds A key on the keyboard is stuck Internal battery capacity is less than 30 min or 8 battery operation overextended The level of oxygen being delivered to the patient is below the Min FIO2 limit set Silence the alarm and call for a medical team if the symptoms persist Check for auto cycling and adjust inspiratory sensitivity manage leaks or drain condensation from patient circuit Have a qualified technician replace the defective component s and call your customer service representative Restart ventilator to see if alarm clears If not replace the ventilator and call your customer service representative Check that the ventilation was switched off on purpose This alarm
39. Max VTE 3000 1000 Vt Min VTE Ton tae a Tor mnro Vt VOLUME CONTROL Vt allows you to set the tidal volume delivered to the patient at each inspiration phase of intermittent or successive controlled breath cycles triggered by the ventilator in the event of patient apnea a A ma For physiological and safety reasons the Vt setting is limited by the settings of Insp Time and Rate The ratio of Vt to Insp Time Vt Insp Time must be 3 lpm lt Vt 60 60 Rate I T Insp Time 1000 lt 100 lpm Note The Backup R value applied depends on the Rate setting Hence Backup R is at least equal to 8 bpm and takes the Rate value if Rate is greater than 8 bpm WARNING Ensure that the patient circuit is appropriate for the tidal volume setting tube 22 mm for adults and 15 mm for pediatric tidal volumes lower than 200 ml P Support PRESSURE SUPPORT When Relative Pressure is set to YES in the Setup Menu P Support allows you to determine inspiratory pressure added to PEEP during the inspiratory phase of spontaneous breaths In this configuration the sum of P Support and PEEP must not exceed 55 mbar When Relative Pressure is set to OFF in the Setup Menu P Support allows you to determine inspiratory Absolute pressure of spontaneous breaths In this configuration P Support and PEEP are related and their settings must maintain a minimum difference between the two of 2 mbar in leak configuration and 5 mbar i
40. Positive End Expiratory Pressure PEEP allows you to determine the level of pressure maintained during the exhalation phase The ventilation mode can be adjusted without PEEP PEEP is nearly 0 mbar when set to OFF A PEEP value can be set to determine the level of pressure maintained during the inspiratory phase and the exhalation phase Apnea Time Apnea time allows the user to monitor and detect interruptions to the patient s spontaneous breathing pattern The ventilator declares apnea when no breath has been delivered by the time that the operator selected apnea interval elapses The Apnea Time AUTO setting is 30 seconds Apnea Time is not available if Apnea Alarm is set to OFF in the Preferences Menu VTI Min and or Max Alarm Settings INSPIRATORY TIDAL VOLUME It is possible to set a Min and or Max Tidal Volume alarm threshold for the patient s inspired tidal volume during a cycle This setting is used to trigger an alarm if the Tidal volume inspired by the patient is lower than the minimum threshold set LOW VTI alarm or greater than the maximum threshold set HIGH VTI alarm Refer to chapter 5 Alarms and Troubleshooting Min VTI and Max VTI are related and their settings must be set to values that maintain a minimum difference of 20 ml between the two It is not mandatory to set the minimum and maximum VTI alarm limits When the minimum and maximum VTI alarm limits are not set the display wi
41. Press ENTER Q amp Q when the cursor is on the Back to Ventilation You will automatically exit from the Preferences menu when e No keyboard action is detected before 15 seconds elapse or e AHigh Priority alarm is triggered 7 3 2 Backlight To set the Backlight 1 Select the Backlight parameter on the display 2 Set the backlight a Toset the backlight to standby select OFF The effect of this setting is that if no keyboard action occurs before one minute elapses the display s backlight fades almost to off The display will illuminate when the following occurs e Any one of the keys on the keyboard is pressed e Analarm is triggered b To set the backlight to light continuously select YES This setting ensures that the display is continuously lit Note If running the ventilator on its internal battery or on an external battery we recommend keeping the backlight setting to OFF to reduce power consumption 7 10 Puritan Bennett 560 Ventilator Clinician s Manual Preferences Menu Parameters 3 Confirm the new Backlight setting before seven 7 seconds elapse The default setting for Backlight is YES backlight lit continuously 7 3 3 Contrast To set the Contrast 1 Select the Contrast parameter on the display 2 Set the Contrast level l i a To increase the contrast press UP 4 This change can be observe as the cursor moves to the right a a The display contrast progressively in
42. Section 3 Operating Parameters each Oo Ventilator alarm settings understanding the purpose and function of each Section 5 7 Overview of Alarms LJ Recognising alarm priority level Section 5 1 Alarm Level of Priority C What to do in case of ventilator alarms and problems Section 5 Alarms and Troubleshooting C What to do if the ventilator alarms inappropriately Section 5 8 Troubleshooting The oxygen setting and why it is required Clinician A 2 Puritan Bennett 560 Ventilator Clinician s Manual Table A 1 Patient Caregiver Checklist Continued How to connect the oxygen source to the ventilator Clinician section 6 8 Oxygen How to determine the quantity of oxygen being ree l i L delivered and how to adjust the quantity SCIEN SEENON GR a ae Chapter 1 Safety Information L Safety rules for the use of oxygen section 6 8 Oxygen C Howto connect the FIO2 sensor to the ventilator Clinician section 6 8 Oxygen go How to recognise and respond to problems with the oxygen supply Techniques to prevent aspiration of vomit Clinician Puritan Bennett 560 Ventilator Clinician s Manual A 3 Patient Caregiver Checklist A 4 This page intentionally blank Puritan Bennett 560 Ventilator Clinician s Manual Specifications B Specifications B 1 Physical Table B 1 Physical Description Excluding Accessories Ventilator Dimensions 9 25 in wide
43. To set the Intentional Vent Stop Alarm amp a gt n 1 Use the UP 4 or DOWN 6 v_ arrows to place the cursor at the Intentional Vent Stop alarm position 2 Press ENTER B a yn Press UP X 4 or DOWN 6 vy to set the message to YES 4 Press ENTER G5 7 3 7 Apnea Alarm To set the Apnea Alarm 1 Use the UP Q A t or DOWN A v_ arrow keys to place the cursor at the Apnea Alarm position 2 Press ENTER G5 3 Press UP Q A t or DOWN A y to set the message to YES Setting the key to OFF means the Apnea Alarm will not sound when the ventilator is stopped 4 Press ENTER A Puritan Bennett 560 Ventilator Clinician s Manual Preferences Menu Parameters WARNING The Apnea Alarm should be set to YES for ventilator dependant patients PB560C86 PREFERENCES oO Backlight OFF o Contrast hz alarm m o Key Sound OFF J o Intentional vent Stop YES EEEE YES C 45s oO Display YWavetorms A o Pediatric circuit OFF o Ventilation Report O Back to Ventilation Figure 7 13 Setting the Apnea Alarm Note This activates disactivates the Apnea alarm but not the Apnea Time Setting The Apnea Time Setting can be set in the Ventilation Menu 7 3 8 Disconnection Alarm To set Disconnection Alarm 1 Use the UP E At or DOWN vy Jarrow keys to place the cursor at the Disconnection Alarm position 2 Press ENTER CY 3 Press UP x a or
44. Vt Apnea Time C m a e e a i oome o oe pe Table 3 10 shows the adjustable alarm parameters in P SIMV mode Table 3 10 Alarm Parameters in P SIMV Ventilation Mode Min Max Adjustment Default Value Value Resolution Value a 3 18 Puritan Bennett 560 Ventilator Clinician s Manual P SIMV Mode Parameters and Setting Ranges Table 3 10 Alarm Parameters in P SIMV Ventilation Mode Continued P Control PRESSURE CONTROL When Relative Pressure is set to YES in the Setup Menu P Control allows you to determine inspiratory pressure added to PEEP during the inspiratory phase of controlled breaths In this configuration the sum of P Control and PEEP must not exceed 55 mbar When Relative Pressure is set to OFF in the Setup Menu P Control allows you to determine inspiratory Absolute pressure of controlled breaths In this configuration P Control and PEEP are related and their settings must maintain a minimum difference between the two of 2 mbar in leak configuration and 5 mbar in valve configuration P Support PRESSURE SUPPORT When Relative Pressure is set to YES in the Setup Menu P Support allows you to determine inspiratory pressure added to PEEP during the inspiratory phase of spontaneous breaths In this configuration the sum of P Support and PEEP must not exceed 55 mbar When Relative Pressure is set to OFF in the Setup Menu P Support allows you to determine inspiratory Absolute pressure of spont
45. a WEST CARE MEoDitsECAL L T D 060 VENTILATOR CLINICIAN S MANUAL Tel 604 540 8288 Fax 604 570 8245 Website www westcaremedical com Rev Contents PREACC oie 55 4000 0s4see eles se sateen e tee eenceee eens Preface 1 1 Safety Information 6 5 00 5 0 0 6 4 509 46 540054 508050 esevewes anes 1 1 kgl DEON err EERE AE OREA 1 1 1 2 Wa eere Ee E E 1 1 1 3 Symbols and WMatKINGS ca uieameryaudune wayne aeeseaees 1 10 1 4 Labels Identification and Instruction Information 1 13 2 Ventilator Overview ccc cece cece e ccc ececcccccccvens 2 1 2 1 Indications for USC unc d cesacddestend cteiaeanie wiaeestanee 2 1 2 2 ContraindicationS ssssesseesessuessresoreseseeeso 2 2 2 3 Operational Use cc sccsunts cane cans basse edhe esas wan oes na 2 2 2 4 Device Classification lt 205sssiwwsernaydsGehes creas lt tees 2 3 2 5 PRONE AMC ssn ee nd obdeet wa nsr EPE Er SEAE 2 4 2 6 Back Panel conde uscer bed eueewrecersis eaccareerrsen teres 2 5 2 7 Control Pan hci acgees ce wednes aveeseeeteaucsrscaunacs 2 6 2 8 Ventilation Menu avis satesdsuGen4etatsceiaaqsavesesceeses 2 7 2 9 Alarm MenU sessnnnnnsunnnensnsssesereseesorssreso 2 8 2 10 Waveforms Menu cc cece eee e eee eeeeeees 2 9 2 11 USBMemory Device Menu ccc cece eee eee 2 10 2 12 If Ventilator Failure Occurs lt 5 csiiecrsatarsrssniacanace eee 2 10 3 Operating Parameters cccccccccccccccccccccccceeces 3 1 3
46. airway bypasses the patient s upper respiratory system the patient s upper respiratory system cannot humidify the incoming gas For this reason the use of a humidifier to minimise drying of the patient s airways and subsequent irritation and discomfort must be used Always position a humidification device so that it is lower than both the ventilator and the patient Use water traps if necessary to limit water in the patient circuit and periodically empty these water traps If a heated humidifier is used you should always monitor the temperature of the gas delivered to the patient Gas delivered from the ventilator that becomes too hot may burn the patient s airway Adding accessories to the ventilator breathing circuit such as a humidifier and water trap s may result in a decrease in tidal volume delivered to the patient due to the added compressible volume of the accessory Always assure that the patient is receiving the appropriate inspired volume when altering the breathing circuit configuration Figure 6 13 Humidifier When a humidification device is used any condensation that forms in the patient circuit is collected in the water trap If you notice any moisture in the patient circuit you need to replace the wet circuit components with dry ones Refer to the humidification device s instruction for information on operating cleaning and sterilising the humidifier Exhalation Block AN WARNING The exhalation block
47. and buttons Section 2 7 Control Panel C The meaning of symbols and markings Section 1 3 Symbols and Markings How to connect the patient to the ventilator via the patient breathing circuit C The parts and purpose of the breathing circuit Chapter 6 Installation and Assembly Chapter 1 Safety Information Chapter How and when to inspect clean and replace the 9 Cleaning Section 10 4 patient circuit Recommended Schedule of Maintenance Section 6 4 Patient Circuit How to recognise and respond to problems with the breathing circuit n Chapter 5 Alarms and Troubleshooting The parts and purpose of the nasal interface or mask Clinician or manufacturer s instructions for use Care of the nasal interface or mask Clinician or manufacturer s instructions for use How to recognise and respond to problems with the Clinician or manufacturer s instructions nasal interface or mask for use LJ Howto install the humidifier Section 6 6 Humidifier go How to perform alarms tests and how to respond if the Appendix F Alarms Tests alarms tests fail Chapter 5 Alarms and Troubleshooting C Howto change the Exhalation Block Section 6 7 Exhalation Block go Replacement interval for outlet filters per the filter Section 10 4 Recommended Schedule manufacturer s instructions of Maintenance g Setting ventilation parameters and the importance of
48. be set to OFF if an FiO sensor is not connected Settings are automatically restored once a sensor is reconnected These settings are the same for all ventilation modes Puritan Bennett 560 Ventilator Clinician s Manual FiO2 For Various Oxygen and Ventilator Settings 3 7 FiO2 For Various Oxygen and Ventilator Settings 50 hae N 40 30 30 Inhalation Flow l min Inhalation flow LPM Volume L x 60 Inspiratory time S Note Tests conducted in a valve configuration Results can vary according to whether the circuit is configured with or without a valve and patient lung characteristics A WARNING The Puritan Bennett 560 Ventilator can be used with an optional oxygen analyser with minimum and maximum concentration alarms Always measure the delivered oxygen with a calibrated oxygen analyser FiO kit that features a minimum and maximum concentration alarm in order to ensure that the prescribed oxygen concentration is delivered to the patient Puritan Bennett 560 Ventilator Clinician s Manual 3 29 Operating Parameters This page intentionally blank 3 30 Puritan Bennett 560 Ventilator Clinician s Manual Digital Monitoring 4 Monitored Parameters 4 1 During ventilation ventilator parameters measured or calculated are highlighted in the menus used for setting the ventilation parameters the alarms and the waveforms In addition to the display of monitored ventilatio
49. be used in order to detect leaks In this case both the minimum and maximum VTE alarm parameters must be properly set to warn in the event of patient suffocation The patient circuit should always be positioned to avoid hindering the patient s movements to prevent accidental disconnection or leakage and to minimise the risk of patient strangulation Ensure that the ventilator s immediate surroundings allow for the proper operational connection of the device without folding pinching or damaging any of the required cables or tubes and that the connection of the patient circuit to the patient provides for a secure comfortable fit The patient circuit is intended for single use by a single patient and should be changed according to the manufacturer s recommendations and according to the patient circuit lifetime Refer to the instructions for use supplied by the manufacturer of the patient circuit included with the ventilator and chapter 6 Installation and Assembly After assembling cleaning or reassembling the patient circuit and on a daily basis inspect the hoses and other components to ensure that there are no cracks or leaks and that all connections are secure To ensure proper performance of the ventilator use a patient circuit recommended by Puritan Bennett in this manual refer to chapter 6 Installation and Assembly and Appendix H Parts and Accessories The total specified length of the patient circuit tubing
50. before the using the ventilator This process is automatic and does not require the use of a measurement device Note Calibration may be done with either an adult or pediatric circuit however Pediatric YES NO must be appropriately selected in the ventilator Preferences Menu To calibrate the exhalation flow sensor Refer to Figure 10 1 as required 1 Ensure the ventilator is on and in Standby mode 2 Ensure the Locking Key is disabled refer to section 7 9 Unlocking the Control Panel on page 7 26 Figure 10 1 Blocking the Patient Wye Double Limb Circuit Shown 3 Obstruct the patient wye s open connector using the fleshy portion of your palm to make a good seal as shown in Figure 10 1 Puritan Bennett 560 Ventilator Clinician s Manual 10 1 Routine Maintenance 4 Press the MENU key to access the alarm settings menu if this is not the menu currently displayed 5 Press the UP x 4 or DOWN QY key to place the cursor on the VTE setup line 6 Press the ENTER WY key twice to access the Patient column central column of the VTE setup line e OFF flashes in the central column e Azoom of OFF is displayed flashing in the window on the right e The message Calibration Exp Flow is displayed in the window on the right Min Current Max j o Alarms Logs Figure 10 2 Calibrating the Exhalation Flow Sensor 1 7 Press the UP 4 or DOWN 6 vy key YES is di
51. cannot be set in V SIMV or P SIMV mode In both the V SIMV and P SIMV modes the Min Time defaults to a setting equal to RISE TIME 300 ms and the Max Time defaults to the lesser of 3 seconds or 30 Rate Rise Time The Rise Time during the inspiratory phase can be set in P SIMV mode and the range is 1 5 The device is configured with a default Rise Time setting of two 2 or a pressure rise time of 200 ms to 800 ms E Sens EXHALATION SENSITIVITY E sens is available in the P SIMV V SIMV and PSV modes In CPAP E Sens is defaulted to 25 and is not adjustable E Sens allows you to determine sensitivity of switching to exhalation and thus indirectly determines the inspiratory time of a breath The end of inspiration will occur when Inspiratory Flow has decreased to the preset E Sens setting The exhalation trigger is only taken into account after the Rise Time which constitutes a default minimum inspiratory time has elapsed If the flow drop is insufficient exhalation is automatically triggered independently of the E Sens which is defined as a percentage of peak inspiratory flow Exhalation may be triggered if the maximum inspiratory time of three 3 seconds has elapsed which corresponds to an I E Ratio of 1 1 0 to ensure that the patient has enough time to exhale Insp a nanni i Figure 3 9 Exhalation trigger sensitivity Note Refer to chapter 7 Operating Procedures for positive and negative E Sens sett
52. ccc cc cece eee eee e eee eeeneeeeees 7 7 Resetting Patient Hours to Zero 2 screcnsesgaeaetwe thes chainsaw one eee wears eers 7 7 Resetting Patient Hours to Zero 3 ccs venawewavaresardcadeanctus beedbeasansiueues 7 8 Resetting Patient Hours to Zero 4 1 0 ccc ccc cece cette eee e eee eeeeeeeees 7 8 Selecting the Preferences Menu cece cece etn e eee e eee e eset ee eeeeennees 7 9 Changing Settings in the Preferences MeENuU ccc cece cece cece ee eeeeeeees 7 9 Setting the Apnea Alarm 6 ccc ccc ccc cece cece eee eeeeeeeeeeeeeeeenees 7 13 Accessing the Ventilation Report cece cece cc eee ee eee e eee eeeeeeeee 7 14 Changing Ventilation Modes While on Standby cc cece cece eee eeeeees 7 15 Changing Ventilation Modes During Ventilation 1 ccc cece eee eens 7 16 Changing Ventilation Modes During Ventilation 2 ccc ccc eee eens 7 16 Changing Ventilation Modes During Ventilation 3 0 ccc cece eee eens 7 17 Changing Ventilation Modes During Ventilation 4 ccc cece eee eens 7 17 Modifying a Ventilation Parameter cece ccc cece een eee eee n ee eeeees 7 18 Setting Links Between Ventilation Parameters ccc ccc ccc cece eee eeeee 7 19 Modifying Alarm Parameters Min Value cece cece cee e teen eee ennes 7 20 Modifying Alarm Parameters Max Valu ccc cece cece teen eeneeeeees 7 20 Selecting the
53. double limb circuit is used is highly recommended Refer to chapter 9 Cleaning To reduce the risk of infection wash your hands thoroughly before and after handling the ventilator or its accessories Cleaning the Ventilator Clean all external panels and surfaces before and after each patient use and as often as necessary to keep the ventilator clean You should clean the ventilator periodically whenever it is soiled or dirty before any maintenance operation and before storing the ventilator A N WARNING Use all cleaning solutions and products with caution Read and follow the instructions associated with the cleaning solutions you use to clean your ventilator Use only those solutions listed in Table 9 1 The ventilator should never be immersed in any liquid and any liquid on the surface of the device should be wiped away immediately To avoid damage to the ventilator in particular the batteries or electrical components fluids must not be allowed to enter the device particularly through the air inlet filter or the cooling apertures located in the side rear and bottom panels of the ventilator To clean the surface of the ventilator 1 Dip a clean soft cloth into a mixture of mild soap and water or other approved cleaning solution Refer to Table 9 1 for a list of approved cleaning solutions 2 Squeeze the cloth thoroughly to remove excess liquid 3 Lightly wipe the external casing of the ventilator taking care
54. down to normal To prevent any interference with the internal sensors of the ventilator do not install a humidifier upstream of the ventilator 6 8 3 Connecting the FIO sensor When administering oxygen it is recommended to use a FiO oxygen sensor that can be connected to the front of the apparatus by means of a FiO measurement kit Puritan Bennett 560 Ventilator Clinician s Manual 6 9 Puritan Bennett 560 Ventilator Clinician s Manual Mounting the Ventilator on a Wheelchair To install the FiO sensor Fam j ib a l j D a L H A D A l p er F E en ae 2 Ze ff ie a i i E k i i r E f fs k i t 1 iON Nf ee Ti S F i ae ae el _ cH A en i r CO es i Iv oe _ Figure 6 18 Connecting the FiO sensor 1 Remove the sensor from the airtight packaging 2 Install the FiO connector to the FiO socket on the ventilator item 1 3 Connect the FiO sensor item 2 onto 15mm adaptor item 3 4 Install the adaptor on the TO PATIENT oN outlet port as shown Fit the patient circuit after the adaptor Note When using a new sensor allow its temperature to become stable for about 20 minutes in ambient air before installing it calibrating it and starting ventilation Mounting the Ventilator on a Wheelchair WARNING Due to its limited internal battery s reserve capacity the ventilator should only be operated on the internal batte
55. external DC power prior to using internal battery power To connect the ventilator to an external power source do the following 1 Ensure the car s engine is started prior to connecting the ventilator 2 Firstly connect the DC power cable into the ventilator 3 Then connect the DC power cable into the car auxiliary adapter Note Whenever AC power is unavailable the ventilator can operate from a continuously powered external 12 30 VDC power source via a DC power cable Figure 6 5 item 1 that connects to the ventilator s rear panel DC power input connector Figure 6 5 item 2 The DC power cable is optional refer to Appendix H Parts and Accessories for more information It is possible to use the DC auxiliary port cigarette lighter in a car as a power source as well Puritan Bennett 560 Ventilator Clinician s Manual Connecting to an External DC Power Source X amp e ii iv i li ii jig h Hf ji NN PA Ss Ze Figure 6 5 Connecting the Ventilator to an External DC Power Source WARNING Connect the external DC power source by first connecting the power cable to the ventilator and then to the external DC source Follow the reverse procedure to disconnect the device from the external DC power source A To connect the DC power cable to the ventilator 1 Line up the red marker dot on the ventilator s DC power connector with the marker on the DC power cable Figure 6 6 item
56. functions and in the long term compromise the longevity of the ventilator Maintenance of the Internal Battery The internal battery does not need to be removed to verify its correct operation Periodic Test of the Internal Battery Your ventilator continuously and automatically checks the state of the internal battery even when the internal battery is not used as the main power source However the battery charge status should be checked MONTHLY by disconnecting the ventilator from external power supplies refer to section 8 2 Battery Operation Such a test is imperative after opening the ventilator or after a prolonged period of non use one month or more in order to ensure the correct operation of internal connections linking the battery to other components J N WARNING The maximum recommended shelf life of the internal battery is two 2 years Do not use a battery that has been stored for two years prior to its first use Periodic recharging is important to help maximize useful life of the battery Do not store the internal battery for extended periods without recharging as this may reduce the maximum life Replacement of the Internal Battery The internal battery should be replaced when the battery capacity drops below 3450 mAh Keep in mind that for environmental protection the ventilator and its components including its internal battery cannot be disposed of with household waste You must submit the ventilator and it
57. if the Tidal volume expired by the patient is lower than the minimum threshold set LOW VTE alarm or greater than the maximum threshold set HIGH VTE alarm Refer to chapter 5 Alarms and Troubleshooting Min VTE and Max VTE are related and their settings must be set to values that maintain a minimum difference of 20 ml between the two VTE is displayed when ventilating with an exhalation valve Setting Min VTE and Max VTE is not mandatory they can be set to OFF but the display of the measured value is always active in double limb configuration Max Leak The setting of a high leakage threshold enables a HIGH LEAKAGE alarm to be triggered in the event the calculated leakage flow exceeds this limit The displayed value corresponds to the mean parasite leakage flow observed during the exhalation phase Max Rtot Max Alarm Setting TOTAL BREATH RATE The maximum rate threshold setting is used to warn of hyperventilation or autotriggering of the ventilator This setting is used to trigger the HIGH RATE alarm Refer to chapter 5 Alarms and Troubleshooting The Max Rtot threshold must always be set at least 5 bpm higher than the Rate If the Rate is readjusted the Max Rtot is automatically readjusted to maintain a minimum difference of 5 bpm Setting the Max Rtot is not mandatory it can be set to OFF but the measured value is always displayed FIO2 Min and or Max Alarm Settings FR
58. in order to avoid the risk of false triggering or autotriggering of the ventilator For example Level 1P the most sensitive mode is recommended for pediatric use However for an adult this setting may result in autotriggering Apnea Time Apnea time allows the user to monitor and detect interruptions to the patient s spontaneous breathing pattern The ventilator declares apnea when no breath has been delivered by the time that the operator selected apnea interval elapses The APNEA TIME adjustment range shall be 1 to 60 seconds The Ventilator shall enable the operator to set an auto setting which shall automatically calculate the APNEA TIME according to the following APNEA TIME 60 BACKUP R for PSV ST mode or 12 s for V SIMV and P SIMV modes The Apnea Time AUTO setting in seconds is calculated using the formula Auto Maximum value between 3 seconds and 60 Backup R or Auto 30 if Backup R OFF Note e During apnea ventilation the ventilator delivers machine controlled breaths according to a backup rate Backup R as long as no inspiratory trigger has been detected e The Backup R value applied depends on the Rate setting Hence Backup R is at least equal to 8 bpm and takes the Rate value if Rate is greater than 8bpm I Time Min and Max The minimum Min I Time and maximum Max I Time duration of the inspiratory phase cannot be set in V SIMV or P SIMV mode In both the V SIMV and P SIMV modes the Min I
59. is less than one minute Other USB memory device functions are not available during deletion Once deletion of the USB memory device has been started it cannot be paused stopped or cancelled All ventilator menus remain accessible during deletion In case of USB memory device disconnection or deletion error the message TRANSFER ERROR USB DISCONNECTION or ERASE ERROR TECHNICAL PROBLEM is displayed In this case restart the transfer process If the problem persists contact your technical service 7 8 Locking the Control Panel When the machine is in service at a patient s home it is strongly recommended that you prevent accidental or unauthorised ventilator adjustments from occurring by enabling the Locking Key The Locking Key is a software function that prohibits access to the ventilation and alarm parameter settings and changes to the ventilation mode Puritan Bennett 560 Ventilator Clinician s Manual 7 25 Operating Procedures To enable the Locking Key Simultaneously press the UP x a and the DOWN 6 v_ keys for at least six 6 seconds e The Locking Key symbol Figure 7 28 item 1 appears in the top left corner of the screen e Lines which are no longer accessible are preceded by a dash Figure 7 28 item 2 e Lines which remain operational keep their initial line access EJ symbol PB560C63 1 Ej PAC ABS FIF 15 mbar PEEP OF 2 Rise Time fk 2 Fate AF bom LE
60. its control tube Restart ventilator to see if alarm clears If not have a qualified technician replace the defective component s and call your customer service representative If oxygen is to be delivered to the patient connect FIO sensor If no oxygen is to be delivered to the patient deactivate FIO alarms Check the level of oxygen corresponds to the patient s prescription or Increase the FIO alarm threshold Note Always consult the clinician before changing PEEP FIO3 pressure volume or Rate settings Puritan Bennett 560 Ventilator Clinician s Manual Alarms and Troubleshooting Table 5 2 Alarms and Corrective Actions Continued Alarm Message or Possible Reason s For The Alarm Event Corrective Action s Symptom Note Ensure that you are operating the ventilator within the proper temperature range refer to Appendix B Specifications Put the device in a warmer environment if the ambient temperature is too low or in a cooler environment if the ambient temperature is too high For example ensure the ventilator is not in direct sunlight or next to an air conditioning vent A WARNING In case of operation in a high ambient Internal ambient temperature of the device temperature handle the ventilator with out of the tolerance ranges care some portions of the device may have high surface temperatures HIGH INT TEMP COOL VENT AN WARNING In the case of high ambient temperatur
61. message 5 10 Electrical specifications B 7 Electromagnetic compatibility and mobile portable communications equipment 6 2 Electromagnetic emissions and use of accessories 6 2 EMPTY BATTERY alarm message 5 10 5 18 8 3 Environment suitable for use of ventilator 2 7 Environmental specifications B 8 Erase Data USB Memory Device 7 25 EXH VALVE LEAKAGE alarm message 5 10 5 19 Exhalation block 6 12 cleaning 9 2 replacement interval 70 6 Exhalation flow sensor calibrating 10 1 Expired Tidal Volume VTE 3 6 F FAA requirements 2 7 Faults technical 5 7 Filters 6 10 air inlet 6 77 antibacterial 6 77 FIO2 3 6 3 9 3 13 3 17 3 22 3 28 oxygen and ventilator settings 3 29 FIO2 sensor calibrating 10 3 calibration 10 3 FIO2 SENSOR MISSING alarm message 5 10 5 19 Fraction of Inspired Oxygen 3 6 3 9 3 13 3 17 3 22 3 28 Freeze function Freezing a waveform trace 4 7 Front panel 2 4 G Gas delivery system diagram C 2 H Heat safety device battery 7 4 6 2 HIGH FIO2 alarm message 5 10 5 19 HIGH INT TEMP COOL VENT alarm message 5 10 5 20 HIGH LEAKAGE alarm message 5 10 5 217 HIGH PRESSURE alarm message 5 71 5 217 High pressure test F 3 HIGH RATE alarm message 5 17 5 22 HIGH VTE alarm message 5 17 5 21 HIGH VTI alarm message 5 17 5 21 HIGH LOW BATTERY TEMP alarm message 5 10 5 20 Holes air circulation 7 3 6 1 Hot surfaces ventilator 7 29 Humidifier 6
62. on off switch on the back panel of the ventilator to indicate the switch s Off position See Figure 2 2 on page 2 5 item 2 Switch in On position IEC 60417 5007 This symbol appears on the I O power on off switch on the back panel of the ventilator to indicate the switch s On position See Figure 2 2 on page 2 5 item 2 Software Lock Enabled This symbol appears on the upper left of the ventilator s LCD display when the keyboard Locking Key is enabled see section 7 8 Locking the Control Panel Internal Battery This symbol appears on the top center of ventilator s LCD display to indicate that the ventilator is being powered by its internal battery See Figure 2 4 on page 2 7 item 1 and refer to chapter 8 Internal Battery for more information Pressure rise times inspiratory phase parameter These symbols appear on the ventilation mode menu screens For more information refer to chapter 3 Operating Parameters In pressure ventilation modes you can select one of four rise times with setting 1 representing the fastest rise time and setting 4 representing the slowest Puritan Bennett 560 Ventilator Clinician s Manual 1 11 Safety Information Table 1 1 Ventilator Symbols Flow shape flow distribution shape inspiratory phase parameter Msa b s These symbols appear on the ventilation mode menu screens selectable for V A C mode only For more information ref
63. over the selected inspiratory time Insp Time Inspiration is triggered by patient generated flow for assisted breaths or by the ventilator for controlled breaths breath rate R Rate is the controlling parameter For both controlled and assisted breaths the inspiration is limited by the volume and is cycled by volume and time The shape of the flow of volume cycles is of the Square type See the waveforms below Amway Start of Inspiration End of Inspiration Pressure Flow l Volume Time SIMV mode will also deliver pressure supported breaths refer to the description for Pressure supported breaths The SIMV mode is a combination of mandatory volume breaths and pressure supported breaths The alternation between them is determined by the setting of breath rate R Rate or period In addition the back up rate will enable the ventilator to ventilate in the case of patient apnea The back up rate is equal to the maximum between 8 and the breath rate R Rate The controlled cycles following an apnea event will be volume cycles These cycles end as soon as a new inspiration trigger is detected When the patient triggers a breathing effort the volume and pressure cycles alternate between each other according to the breath rate setting R Rate All the cycles are synchronised on inspiration triggers A period always includes a volume cycle plus as many
64. proximal pressure link In such cases the PATIENT DISCONNECTION alarm would not be systematically activated in case of a disconnection of the circuit Most breaths are triggered by the patient You should carefully modify the inspiration trigger threshold in order to avoid the risk of false triggering or autotriggering of the ventilator For example Level 1P the most sensitive mode is recommended for pediatric use However for an adult this setting may result in autotriggering 7 4 1 Changing Modes While Ventilation is on Standby To change ventilation modes while on standby 1 Place the cursor on the first line of the menu general information line using the UP Q A t key PB560C40 a PAC ABS o PIP 45 mbar o PEEP OF o Rise Time 72 x D o Rate 13 bpm OME 1 2 0 e ARETE TO START o Sens 2 ovtTarget OFF BE VENTILATION O Preferences Figure 7 15 Changing Ventilation Modes While on Standby 2 Press ENTER G5 e The cursor changes to P e The mode name flashes 3 Press UP x t or DOWN a v_ until the required mode is displayed 4 Press ENTER Cv to confirm the mode selected e The cursor returns to normal e The new mode is displayed with its ventilation parameters If the ventilation mode change is not confirmed by pressing ENTER WY before seven 7 seconds elapse the ventilator restores the previous mode Puritan Bennett 560 Ventilator Clinician s Manual 7 15 Operating P
65. reached by successively or continuously pressing UP a t or DOWN 6 v_ respectively If a parameter change is not confirmed by pressing ENTER G before seven 7 seconds elapse the ventilator restores the parameter s previous value Blocking of an Alarm Threshold Linked to a Ventilation Parameter Setting a ventilation parameter takes priority over an alarm threshold setting Therefore if a ventilation parameter is modified when linked to an alarm threshold the alarm setting threshold is automatically adjusted so that the interdependences linking them are always maintained However if the alarm setting threshold is modified it cannot be changed beyond the limit of the interdependence with the ventilation parameter to which it is linked When the alarm setting limit is reached the message Setting limited by indicates the name of the linked ventilation parameter s that are limiting the parameter s setting value For more information on the relationship between alarm setting limits and ventilation parameters refer to chapter 7 Operating Procedures Four possibilities exist in this case e The alarm parameter remains set to OFF e Thealarm parameter setting is changed in relation to the value required at the start and the limits on the ventilation parameter s remain unchanged e The setting of the ventilation parameter s is changed to enable the alarm threshold to be set to the required value e The al
66. regulatory requirements may vary depending upon the country and mode of transport Therefore it is recommended that users verify with the carrier airline as to which measures to take before the voyage Target Operators The ventilator may be operated by e Respiratory therapists e Doctors e Nurses e Homecare providers Puritan Bennett 560 Ventilator Clinician s Manual 2 1 2 2 2 3 2 2 e Patient and patient s families For more details on the knowledge and skill requirements for operating the Puritan Bennett 560 Ventilator refer to Appendix A Patient Caregiver Checklist A N WARNING This ventilator must be used only under the responsibility and on the prescription of a doctor Contraindications This ventilator is not for use with anesthetic gases and is not intended for use as an emergency transport ventilator Operational Use The Puritan Bennett 560 Portable Ventilator uses a micro turbine to provide ventilatory support to patients Clinicians may use a variety of interfaces to connect patients to the ventilator nasal masks or full face masks endotracheal or tracheotomy tubes User selectable ventilation modes are e Assisted Controlled Volume V A C e Assisted Controlled Pressure P A C e Volume Synchronised Intermittent Mandatory Ventilation V SIMV e Pressure Synchronised Intermittent Mandatory Ventilation P SIMV e Continuous Positive Airway Pressure CPAP e Pressure Support Ventilation
67. settings Clean unblock and or properly connect the vented mask or check that the built in leak is sufficient for the PEEP setting Restart ventilator to see if alarm clears If not replace the ventilator and call your customer service representative POWER FAULT Internal problem in the electrical power RESTART SRVC supply Press the I O switch to restore electrical power to the ventilator and allow ventilation to continue Electrical power supply cut off by the main switch when ventilation is in progress To stop ventilation press the POWER SUPPLY LOSS VENTILATION ON OFF key for three seconds refer to chapter 7 Operating without message Procedures Immediately connect the ventilator to an The internal battery that supplies the AC power outlet or an external DC power ventilator is entirely discharged source otherwise use an alternate device to ventilate the patient Restart ventilator to see if alarm clears If not have a qualified technician replace the defective component s and call your customer service representative PRES SENS FLT1 RESTART SERV Defective internal pressure sensor Restart ventilator to see if alarm clears If PROA SENS PEIZ Defective proximal pressure sensor or not have a qualified technician replace RESTART SRVC internal leak of the machine the defective component s and call your customer service representative Remove exhalation valve to start The ventilation settings
68. specified below The customer or the user of the ventilator should assure that it is used in such an environment RF emissions The ventilator uses RF energy only for CISPR 11 EN 55011 its internal functions Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions Class B The ventilator is suitable for use in all CISPR 11 EN 55011 establishments including domestic 4 establishments and those directly PONE ENAREN Crds connected to the public low voltage IEC EN 61000 3 2 power supply network that supplies Voltage fluctuations Complies buildings used for domestic flicker emissions purposes IEC EN 61000 3 3 B 10 Puritan Bennett 560 Ventilator Clinician s Manual Specifications Table B 21 Electromagnetic Immunity The ventilator is intended for use in the electromagnetic environment specified below The customer or the user of the ventilator should ensure that it is used in such an environment Electromagnetic Immunity Test IEC EN 60601 Test Level Compliance Level Environment Guidance Electrostatic discharge ESD IEC EN 61000 4 2 Electrical fast transient burst IEC EN 61000 4 4 Surge IEC EN 61000 4 5 Voltage dips short interruptions and voltage variations on power supply input lines IEC EN 61000 4 11 Power frequency 50 60 Hz magnetic field IEC EN 61000 4 8 6 kV contact 8 kV air 2 kV for po
69. the Puritan Bennett respiratory insight software Puritan Bennett 560 Ventilator Clinician s Manual PB560C71 USB MEMORY DEVICE SIN 40966K0001 USB Menu Parameters PB560C72 USB MEMORY DEVICE SIN 40966K0001 Transfer Continuously YES o Transfer Trends OFF Transfer Continuously YES Transfer Trends OFF o Erase Key OFF Erase Key OFF TRANSFER IN PROGRESS Remaining Time OHO min Figure 7 25 Selecting Transfer Continuously To transfer continuous data from a ventilator to a USB memory device 1 Use the UP 4 or DOWN 6 Y arrow keys to place the cursor at the Transfer Continuously position 2 Press ENTER GA e The cursor changes to the plus minus symbol e The parameter selected to be modified flashes 3 Press UP 4 or DOWN CY to change the selected parameter s value 4 Press ENTER CY to confirm the new parameter setting e The new parameter setting is displayed continuously e The cursor is placed at the STOP position 5 To manually stop continuous transfer press the ENTER key If a parameter change is not confirmed by pressing ENTER G before seven 7 seconds elapse the ventilator resets the parameter to its previous value Note All ventilator menus remain accessible during transfer time The message TRANSFER IN PROGRESS REMAINING TIME is displayed during the transfer time Other functions of the USB memory device are not available dur
70. the device to an AC power outlet connect it to an external DC power source or replace the battery Reminder the internal battery can be charged only when the ventilator connected to an AC power supply Puritan Bennett 560 Ventilator Clinician s Manual Alarms and Troubleshooting Table 5 2 Alarms and Corrective Actions Continued Alarm Message or Symptom E SENS FAULT OR CIRC LEAK EXH VALVE LEAKAGE FIO2 SENSOR MISSING HIGH FIO2 Leak in the patient circuit leak in patient artificial airway or vented mask interface E sensitivity setting not properly adjusted Large leakage detected on the patient circuit return limb during the inspiratory phase Contaminated or defective exhalation flow sensor There is no FIO sensor and FIO alarms are active The level of oxygen being delivered to the patient is higher than the Max FIO limit set Possible Reason s For The Alarm Event Corrective Action s Note Always consult the clinician before changing PEEP FIO gt pressure volume or Rate settings Check and properly connect the patient circuit connections Minimise the leak Ensure O connector is removed Reduce inspiratory time Increase E Sensitivity setting Check tracheotomy cuff Refit mask Use non vented mask Check E Sensitivity setting Note Always consult the clinician before changing PEEP FIO gt pressure volume or Rate settings Replace the exhalation valve and or
71. the patient s environment Alarm sound level 00 low or too high Re adjust sound level refer to section 7 3 Preferences Menu Parameters 5 25 Puritan Bennett 560 Ventilator Clinician s Manual Alarms and Troubleshooting Table 5 3 Additional Troubleshooting and Corrective Actions Continued Poor visibility of Contrast adjustment is incompatible Re adjust contrast refer to section 7 3 the displays with the luminosity of the environment Preferences Menu Parameters Adjust contrast or call your customer service representative if the problem Problem with the display unit persists Ensure that the ventilator is not exposed to direct radiation from the sun Unusual display on the screen The ventilator does not operate after pressing No external power source and the internal battery is completely discharged Connect the ventilator to the AC power source I O switch tiahthoi Torbimenene Replace the ventilator and call your Enzi customer service representative Filter and or turbine silencer Replace the ventilator and call your Whistling noise or deteriorated customer service representative vibrations Replace the ventilator and call your Valve membranes damaged l customer service representative Excessive heat Obstruction of main or secondary air Remove obstructions from all blocked emitted inlets of the casings ventilator air inlets and outlets Condensation Liquid entered the device Repla
72. to 99 mbar Vae Pa A pi oo The displayed value is updated at each inspiration Flow delivered at each breath to the patient is Minute Volume M Vol 0 to 99 9 measured by the inspiratory transducer and that measurement is used to calculate minute volume Vt x Rtot the flow transducers do not directly measure volume The displayed value is updated at each exhalation Highest circuit pressure during each inspiration Peak Inspiratory 0 to 99 mbar phase measured with the proximal pressure sensor Pressure The displayed value is updated at each exhalation End exhalation pressure is measured by the ils Expiratory PEEP 0 to 99 mbar proximal pressure sensor heads The displayed value is updated at each inspiration Total ber of breaths measured per minute Riot 0 to 99 bpm ota aun ero es ured p inu The displayed value is based on each breath and is updated at each inspiration Bargraph Display In the ventilation menu the highlighted bargraph dynamically displays pressures established throughout the breath cycle Figure 4 13 Puritan Bennett 560 Ventilator Clinician s Manual 4 5 Monitored Parameters a PAC ABS o PIP 15 mbar o PEEP OFF m 14267 mL o Rise Time 72 a gt 454m 13bpm f Vol 0 0L 1 1 2 0 gt 15bpm ee 99259 oOvVtTarget _ 0 o Preferences mbar Figure 4 13 Bargraph Display PB560C30 The PIP value reached during a cycle is represented by a line at the top of the bargraph Figure 4 1
73. to increase e The exhalation valve must allow rapid discharge of the circuit pressure Ensure that the exhalation valve is always clean and its evacuation aperture exhaust port is never obstructed e Users must always possess an additional breathing circuit and exhalation valve while using the Puritan Bennett 560 Ventilator e Always ensure that the humidification device is positioned lower than both the ventilator and the patient Use water traps if necessary to limit water in the patient circuit and periodically empty these water traps e Ifaheated humidifier is used you should always monitor the temperature of the gas delivered to the patient Gas delivered from the ventilator that becomes too hot may burn the patient s airway e Adding accessories to the ventilator breathing circuit such as a humidifier and water trap s may result in a decrease in tidal volume delivered to the patient due to the added compressible volume of the accessory Always assure that the patient is receiving the appropriate inspired volume when altering the breathing circuit configuration e The level of inspiratory resistance of the circuit and accessories bacteria filter humidifier HMEs etc must be as low as possible Settings particularly the PATIENT DISCONNECTION alarm maximum inspired volume Max VTI and minimum inspired volume Min VTI settings must be periodically adjusted according to changes in the patient circuit resistance especiall
74. to silence an audible alarm for Changes the displayed menu From the Ventilation menu 60 seconds screen press this key to display the Alarm menu screen e Press twice to halt visual and audible alarms When a USB memory device is inserted into the ventilator If alarm is remedied the alarm is cancelled press this key to display the USB memory device screen other than the high pressure alarm 3 Display screen 8 VENTILATION ON OFF button Display of modes ventilation settings patient e Press briefly and release to start ventilation data and waveforms configuration of the e Press for three 3 seconds to stop ventilation ventilator and alarm management 4 UP UNFREEZE Key 9 Ventilation status indicator e Moves the cursor up and increases e Blue indicator illuminated device is powered on and parameter values ventilation is off on standby e During ventilation reactivates waveform e Blue indicator off ventilation is on tracing in the Waveform menu 5 ENTER key 10 Electrical power source indicators e Access to a setting value and validation of e AC POWER indicator lit AC power source connected the modification of this setting e DC POWER indicator lit DC power source connected e Access to a sub menu e INTERNAL BATTERY indicator lit continuously Internal battery in use no external power source connected e INTERNAL BATTERY indicator flashing battery charging Figure 2 3 Control Panel 2 6 Puritan Bennett 5
75. use with medical grade oxygen Under no circumstances should the oxygen hose be modified by the user In addition the hose must be installed without the use of lubricants e Ensure that the only gas supplied to the ventilator through the dedicated oxygen supply connector is medical grade oxygen e The coupler must not remain connected to the oxygen connector unless it also connected to a leak proof external oxygen gas source When an oxygen supply is not being used with the ventilator disconnect the oxygen source completely from the ventilator e To prevent any interference with the internal sensors of the ventilator do not install a humidifier upstream of the ventilator e To ensure stability when the Puritan Bennett 560 Ventilator is mounted on a cart the weight of the oxygen bottle should not exceed 14 kg 30 Ibs e The oxygen supply hose ages even when it is not in use and should be replaced periodically The expiration date may be located on the back of the hose end piece e The oxygen supply must be regulated using a flow meter connected to the source gas outlet e The oxygen supply must be shut off when ventilation is interrupted Before disconnecting the oxygen hose allow the ventilator to continue for a few cycles without oxygen to flush the patient circuit of excess oxygen e Before connecting the oxygen supply ensure that the stud on the oxygen connector is protruding outwards e Inspect the oxygen coupler before
76. used to adjust the flow distribution shape or ramp pattern during the inspiratory phase The three flow patterns available are e Ramp Pattern sa square waveform or constant flow e Ramp Pattern p Decelerated sawtooth waveform or decreasing flow e Ramp Pattern Jay Sinusoidal flow Rate RESPIRATORY RATE Rate allows you to define the frequency of ventilation cycles triggered by the ventilator If the patient actuates the inspiratory trigger Total Rate may increase For physiological and efficiency reasons Rate setting is limited by the settings of Vt and I E I T IE I T Ratio INSPIRATION AND EXHALATION RATIO E allows you to determine the ratio between the inspiratory breath phase duration and the exhalation breath phase duration I T allows you to determine the ratio between the inspiratory breath phase duration and the total breath duration inhalation exhalation Note Puritan Bennett 560 Ventilator Clinician s Manual 3 15 Operating Parameters Insp Time is not a setting and is displayed as Ti when the I E or I T ratio is adjusted I Sens INSPIRATORY TRIGGER SENSITIVITY Sens allows you to set the level of inspiratory effort the patient has to provide to initiate a machine breath The sensitivity levels decrease from 1P to 5 the lower the number the more sensitive the trigger sensitivity These levels correspond to differences in flow compared to the bias flow Sens 1 P Bias fl
77. wh ean insae kaa B 3 Filan tin WICNCALOUS 5 044 454 EE 2b ie E E wa wa a AO eee Oren ben E EET B 3 AUGO AI E e cu gare cts rach 3 4414 45 4 b ho an 8 eee va ee ee eee ewes aia ees B 3 Performance Parameter Specifications and Tolerances ccc cece cece ee eeees B 3 Monitored Parameter Specifications and Tolerances c cece eee e cece ee eees B 3 Ventilator Range Resolution and ACCUraCcy ccc cece cece cece eee eee eeenaes B 5 Environmental Conditions for Storage or Transport ccc cece eee eee eens B 8 Environmental Conditions for Operation 0 ccc ccc ccc ccc ccc eee eee eeeees B 8 USB Memory Device Specifications 0 ccc ccc ccc een cece e etn e eee eeeeeeennes B 8 Data Transfer Characteristics iis 04444454 sndndee teeettens ae eedeeeesan poneteues anaus B 9 PIIRWAY RESISTANCES 222 nnccaneatandn save tagueetaes eh vesheognenuaerecdewasutexnectes B 9 Patient Circuit Resistances ptecuceresceateenedecas cs eaedawed Gu auaeee eke wetee ees B 9 Air Inlet Resistance Fiter s cccsrrssrrusesandrnad ass E SEE ss ew eenes Chane penne ens B 9 Oxygen Inlet Specifications sssri cry ooen veer enceuvey IRERE E E ERR B 9 Performance Specifications 0 0 ccc cece eee cece cece e ee eeeeeeeeneees B 9 Electromagnetic EMISSIONS cctccanicrawctddvdomnhreaauigpirtadatatatireentanes B 10 Puritan Bennett 560 Ventilator Clinician s Manual ix Table B 21 Table B 22 Table B 23 Table B 24 Table E 1 Tabl
78. x 12 40 in deep x 6 0 in high femme easmmnterssnm eor sammon Connectors Inspiratory limb connector ISO 22 mm OD conical Exhalation limb connector on exhalation block ISO 22 mm ID conical Oxygen inlet Female Connector with valve Breathingcraitvoume SSCS Air Inlet Filter Dimensions 70 mm long x 60 mm wide Composition Polypropylene fiber electrostatic filter material which is laminated onto polyurethane open celled foam Efficiency 99 54 at 24 lpm filtering microbes 2 5 um to 3 um Inspiratory Bacteria Filter Maximum allowable flow resistance 4mbar at 60 lpm Requirement B 2 Electrical Table B 2 AC Electrical Supply Table B 3 Internal Lithium lon Battery Voltage 25 2 VDC Full load capacity 4 8 Ah Ampere hour rating On standby 1 5 Ah During ventilation 0 5 Ah Watt hour rating 124Wh to 126Wh B 1 Puritan Bennett 560 Ventilator Clinician s Manual Specifications B 2 Table B 3 Internal Lithium lon Battery Continued Charging current e Standby mode e Ventilation mode Vt 200 ml 5 ml PIP 10 mbar 2 mbar Rtot 20 bpm Vt 300 ml 5 ml PIP 20 mbar 2 mbar Rtot 15 bpm Vt 500 ml 5 ml PIP 30 mbar 2 mbar Vt 750 ml 5 ml PIP 45 mbar 2 mbar Rtot 20 bpm maximum settings Table B 4 Remote Alarm Remote Alarm Port Also known as the Nurse s Call port it provides for remote alerts of ventilator alarm conditions An exampl
79. you to determine that the correct level of oxygen is being delivered to the patient Min and Max FiO thresholds can be set to trigger LOW FIO2 or HIGH FIO2 alarms FiO Min and FiO Max thresholds are related and their settings must maintain a minimum difference of 10 between the two Min and Max FiO settings can be set to OFF if an FiO sensor is not connected Settings are automatically restored once a sensor is reconnected These settings are the same for all ventilation modes Puritan Bennett 560 Ventilator Clinician s Manual 3 17 Operating Parameters 3 5 PSIMV Mode Parameters and Setting Ranges The menus in the P SIMV Synchronised Intermittent Mandatory Ventilation Pressure ventilation mode are shown in Figure 3 8 PB560C14 PB560C15 e P SIMY ABS o F Control 15 mbar o P Support 15 mbar 994mL o PEEP OFF z 429mL o Rise Time 72 1 o D 0 0L o Rate 13 bpm ee gt 21 bpm o Insp Time 1 5s M 4 2 4 o Sens 2 Me io o 241 oESens 25 i o Apnea time AUTO O Preferences ae Si o Alarms Logs Figure 3 8 Menus in P SIMV Ventilation Mode Table 3 9 shows the adjustable Ventilation parameters in P SIMV mode Table 3 9 Ventilation Parameters in P SIMV Ventilation Mode Min Max Adjustment Default Value Value Resolution Value Linked Parameters P Control cmH 30 mbar or hPa cmH 0O mbar or hPa cmH 0O P Support mbar or hPa P Control Max Rtot Insp Time Rate
80. 1 Align the red markers dots and or lines before connecting the cable Push in to Connect the 2 DC Power Cable Figure 6 6 Connecting the DC Power Cable to the Ventilator 2 Push the DC power cable onto the ventilator s DC power connector Figure 6 6 item 2 e You will hear a locking click e The DC POWER Figure 6 4 indicator on the top left corner of the ventilator illuminates see To disconnect the DC power cable from the ventilator slide the locking ring Figure 6 6 item 3 back and pull the plug away from the ventilator s rear panel to disengage it An DC POWER DISCONNECTION alarm signals an automatic switch to the internal battery in case the external DC power source fails or becomes disconnected Puritan Bennett 560 Ventilator Clinician s Manual 6 5 Installation and Assembly 6 4 Patient Circuit 6 6 A WARNING Before opening the packaging for the Patient Circuit ensure that no damage is evident to the packaging or its contents Do not use if evidence of damage exists For pediatric use ensure that the patient circuit type fits and in all respects is suitable for use with a child Use a pediatric circuit for patients that weigh under 53 Ib 23 kg See Table H 2 List of Circuits on page H 2 for a list of recommended patient circuits If exhaled tidal volume measurements are required to ensure correct patient ventilation a double limb patient circuit configuration must
81. 1 P Bias flow 0 4 lpm to 1 lpm P Pediatric use Sens 2 Bias flow 0 7 lpm to 1 3 lpm Sens 3 Bias flow 0 9 lpm to 1 5 lpm Sens 4 Bias flow 1 0 lpm to 1 6 lpm Sens 5 Bias flow 1 2 lpm to 1 8 lpm The bias flow consists of turbine flow through the patient circuit during the exhalation phase that helps the patient avoid rebreathing exhaled gas CO The inspiratory trigger is initiated after a time delay of between 700 ms to 1500 ms depending on the preceding peak inspiratory flow Sens can be set to OFF AN WARNING The inspiration trigger threshold should be carefully modified in order to avoid the risk of false triggering or autotriggering of the ventilator For example Level 1P the most sensitive mode is recommended for pediatric use However for an adult this setting may result in autotriggering VT Target TARGET TIDAL VOLUME VT Target allows the ventilator to deliver a target volume of air to the patient When a VT Target is set the ventilator constantly adjusts the target inspiratory pressure between PIP and Max P to ensure the inspired tidal volume remains as close as possible to the VT target VT Target should be more than 10 ml higher than Min VTE and more than 10 ml lower than Max VTI to avoid triggering VTI or VTE alarms The minimum increase or decrease of target inspiratory pressure is 0 5 mbar and the maximum is 2 mbar Setting the Vt Target is not mandator
82. 1 2 0 Sens 2 VtTarget OFF Figure 7 28 Installing the Locking Key 7 9 Unlocking the Control Panel To disable the Locking Key Simultaneously press the UP a and the DOWN A v_ keys for at least six 6 seconds e The Locking Key symbol disappears e The initial line access symbol is displayed in front of each line 7 10 Starting Ventilation Before starting ventilation refer to Appendix E Operational Verification Checklist and set the parameter values in the Preferences menu refer to section 7 3 Preferences Menu Parameters on page 7 8 WARNING Verify the functionality of the alarm conditions before connecting the patient to the ventilator Before starting ventilation ensure that the device is properly assembled and that the air inlet cooling vents and alarm sound diffusion holes are not obstructed Ensure also that the patient circuit is of the proper configuration double or single limb properly connected to the ventilator and that the circuit hoses are neither damaged nor compressed and contain no obstructions or foreign bodies 7 26 Puritan Bennett 560 Ventilator Clinician s Manual Starting Ventilation When the ventilator is in standby the ventilator is on but ventilation has not started a message that prompts the ventilator operator to press VENTILATION ON OFF to start ventilation is displayed in the right hand window of the ventilation and alarm menus Figure
83. 12 volt DC outlet Nurse call cable 5 metres Exhalation block single patient use blue Inlet air combi filter fine pack of 6 Note This is the foam plus fine particle filter listed in Table 10 1 Consumables and Replacement Intervals on page 10 6 Internal battery External battery DAR Inspiratory Bacteria Filters Barrierbac Barrierbac S Barrierbac S Angled Hygrobac Hygrobac S Hygrobac S Angled Puritan Bennett 560 Ventilator Clinician s Manual H 1 Parts and Accessories Table H 1 List of Consumables and Accessories Description Hygroboy Hygroster Hygroster Mini Sterivent Sterivent S Sterivent Mini Hygrolife Il Table H 2 provides a list of consumable parts available for the ventilator WARNING To ensure proper performance of the ventilator use a patient circuit recommended by Covidien in this manual refer to chapter 6 Installation and Assembly and Appendix H Parts and Accessories The total specified length of the patient circuit tubing as measured from the ventilator outlet to the ventilator inlet is 1 1 metres 3 6 ft to 2 0 metres 6 6 feet The tubing must conform to all applicable standards and must be fitted with 22 mm terminals that also conform to all applicable standards Ensure that both the length and the internal volume of the patient circuit are appropriate for the tidal volume a corrugated tube of 22 mm for adult patients and a corrugated tu
84. 15 Ventilation Report Note The values displayed in the Ventilation Report are reinitalised when the software is updated or the patient counter is reset to zero Puritan Bennett 560 Ventilator Clinician s Manual 4 7 The following data is displayed in the Ventilation Report Vent Time Ventilation Time The ventilation duration data is based on the patient counter and shows the total ventilation time in hours and minutes over the precious 24 hour period VTI Inspired Tidal Volume When ventilating with an exhalation valve the VTI is the average inspired tidal volume during each ventilation cycle over the previous 24 hour period When ventilating in leak mode the VTI is the average volume delivered by the ventilator during each ventilation cycle over the previous 24 hour period VTE Exhaled Tidal Volume When ventilating with a double limb circuit configuration and an exhalation valve the VTE is the average exhaled volume during each ventilation cycle over the previous 24 hour period In a single limb circuit configuration this value is not measured PAW Peak Airway Pressure The Peak Airway Pressure is the average peak pressure during the inspiratory phase measured by each cycle and over the previous 24 hour period Rate Respiratory Rate The Respiratory Rate is the average of the total respiratory frequency of the patient and the ventilator measured over the previous 24 hour period Leak When ventilati
85. 2 skipping 7 3 Wheelchair mounting the ventilator onto 6 17 Puritan Bennett 560 Ventilator Clinician s Manual
86. 20 C 36 F from the temperature in which it will be operating the ventilator should be allowed to stabilise in its operating environment for at least two 2 hours prior to use e Ifthe ambient temperature where the device is operated is greater than 35 C 95 F the flow supplied at the device outlet may exceed 41 C 106 F This may lead to undesirable side effects for the patient To avoid injury to the patient move the patient and the ventilator to a cooler location For more information contact Covidien e The default setting for altitude compensation is YES Altitude compensation should always be set to YES for accurate volume delivery calculations at all elevations e To reduce the risk of a fire hazard keep matches lighted cigarettes and all other sources of ignition such as flammable anesthetics and or heaters away from the ventilator and oxygen hoses e Regularly check the cleanliness of the air inlet filter located on the rear of the ventilator If necessary replace the filter before the recommended replacement period is over see chapter 10 Routine Maintenance This is particularly important when the ventilator is installed on a wheelchair because environmental conditions may cause the filter to become dirty more rapidly e Handle the ventilator with care during and after use particularly when ambient temperatures are high Some ventilator surfaces may become hot even if safety specifications are not exce
87. 3 item 1 which remains displayed until the maximum value of the following cycle has been reached The PEEP value is represented by a line at the bottom of the bargraph Figure 4 13 item 2 4 3 Waveform Display The waveform screen is only accessible during ventilation from the alarm parameters screen using the MENU key Its display has been configured in the Preferences menu refer to chapter 7 Operating Procedures e The Pressure waveform and the Flow waveform are referenced to Time On these waveforms the maximum Pressure and Flow lines are updated each time the graphic window is refreshed every two breath cycles e The scales for Pressure and Flow automatically adjust according to the maximum levels measured over the last three cycles The time scale also adjusts automatically according to the breath rate frequency which allows the display of two consecutive cycles The waveform screen is shown in Figure 4 14 1 PAC 4 mbar EE E EE 2 3 4 IRR SRR a yer sip sce eee ET mene eer EE A ea re Fin Oe ys Dea pent 2 mL Figure 4 14 Waveform Screen PB560C31 1 Ventilation Mode Pressure over last two cycles Maximum Flow over last two cycles Frozen waveform symbol Inspiratory trigger symbol Pressure and flow scales are adjusted over three cycles but only two cycles are displayed Waveform tracing can be frozen at any time which enables the analysis of
88. 6 4 oxygen 6 14 oxygen supply figure 6 75 the oxygen supply 6 14 Consumables replacement intervals 10 6 Continuing pressure test F 2 Contraindications against use of ventilator 2 2 Contrast display setting 7 11 CONTROLLED CYCLES alarm message 5 9 5 18 Cooling fan C 7 COOLING FAN alarm message 5 9 5 18 CPAP mode 3 7 CPAP Mode Menu Alarm parameters 3 7 D DC power cable connecting to ventilator 6 5 disconnecting from ventilator 6 5 connecting to 6 4 DC POWER DISCONNECTION alarm message 5 9 5 18 6 5 Device classification 2 3 DEVICE FAULT 11 alarm message 5 10 DEVICE FAULT10 alarm message 5 10 5 18 DEVICE FAULT11 alarm message 5 10 5 18 DEVICE FAULT12 alarm message 5 10 5 18 DEVICE FAULT13 alarm message 5 10 DEVICE FAULT3 alarm message 5 9 5 18 DEVICE FAULT5 alarm message 5 9 5 18 DEVICE FAULT7 alarm message 5 9 5 18 DEVICE FAULT9 alarm message 5 9 5 18 Digital monitoring 4 7 Display of alarms 5 2 setting the backlight 7 10 setting the contrast 7 11 showing waveforms 7 13 waveforms 4 6 Display Waveforms parameter 7 13 Display bargraph 4 5 Displayed parameters Puritan Bennett 560 Ventilator Clinician s Manual monitored 4 4 Dual bag accessory 6 18 Dual Bag figure 6 18 G 2 E E Sens 3 4 exhalation sensitivity 3 26 E Sens exhalation sensitivity 3 21 E SENS FAULT 5 79 E SENS FAULT OR CIRC LEAK alarm
89. 60 Ventilator Clinician s Manual 2 8 Ventilation Menu Ventilation menu with ventilation on standby Ventilation menu during ventilation oL O Preferences 4 General information line Displays the current ventilation mode along with the following Battery symbol if the device is powered by the internal battery Audio paused X symbol if an alarm is currently inhibited Alarm paused ZX symbol if an alarm has been cancelled manually and the cause of the alarm remains Apnea Alarm deactivation wR Exhalation valve symbol No exhalation valve x symbol Absolute ABS symbol Relative REL symbol Bargraph Displays pressure generation during ventilation Puritan Bennett 560 Ventilator Clinician s Manual ABS 500m OFF rt AF bom 1 2 0 OFF OFF o PC E F Control o FEEP o Rise Time o R Rate DIE o insp Sens o t Target ABS 0 mbar 10 mbar AF bom i OFF OFF O Preferences Se Ventilation settings Displays the specific ventilation parameter values for the currently selected ventilation mode Refer to chapter 3 Operating Parameters for more information Status monitored data window e Ventilation stopped Standby displays the message PRESS TO START VENTILATION e Ventilation on parameters are monitored and displayed e The Inspiratory Effort Detected symbol appears adjacent to the monitored I E ratio when the pati
90. 7 29 PB560C64 oP A C ABS o PIP 145 mbar m FEEF OF o Rise Time 2 o Rate 136pm 1 2 0 4 TO START ovtTarget OFF me VENTILATION O Preferences mbar Figure 7 29 Prompt to Start Ventilation To start ventilation Press and release VENTILATION ON OFF Figure 7 30 item 1 e The blue light indicator at the upper right of the VENTILATION ON OFF Q key see Figure 7 30 item 2 turns off e A beep sounds e The ventilation starts e The values of the monitored parameters are displayed in the right hand window Front Panel Keyboard E J COVIDIEN Puritan Bennett 560 Ventilator a fia i VEN _10037_C Figure 7 30 Starting Ventilation Puritan Bennett 560 Ventilator Clinician s Manual 7 27 Operating Procedures 7 11 Stopping Ventilation WARNING Do not allow a patient to remain connected to the ventilator when ventilation is stopped because a sub stantial quantity of expiratory gas primarily carbon dioxide may be inhaled by the patient In some cir cumstances inhaling carbon dioxide may lead to under ventilation suffocation and serious injury or death You can stop your ventilator at any time To stop the ventilator 1 Hold down the VENTILATION ON OFF key Figure 7 30 item 1 for about three 3 seconds e Amessage prompting the user to keep the button pressed appears on the monitoring window as shown in the graphic below PB560C65 oP AC ABS o P
91. 7 8 Locking the Control Panel on page 7 25 and section 7 9 Unlocking the Control Panel on page 7 26 The Setup menu cannot be accessed if the ventilator had been powered off without first placing the device into standby 1 Check the ventilator s I O switch is set to OFF O position 2 Press and hold the ALARM CONTROL key while switching the I O switch to the ON I Hold the key until the Setup menu appears approximately three seconds Refer to Figure 7 4 PB560C52 SETUP Machine Hrs 00000h m Language ENGLISH O Date 01 JAN 2099 o Time 00 30 39 o Cycling Mode mH o Relative pressure OFF o Pressure Unit mbar o E Sens Settings POSITIVE O Patient Hours 00000h OOmin o Reset Hours OFF o Maintenance Figure 7 4 Setup Menu 3 Release the ALARM CONTROL key Puritan Bennett 560 Ventilator Clinician s Manual 7 3 Operating Procedures 7 2 2 Changing the Setup Menu Parameters To change the Setup Menu settings 1 2 Press ENTER V e The cursor changes to 4 Note Press UP a or DOWN y to position the cursor beside the parameter to be modified e The selected parameter value flashes Press UP a or DOWN A v_ to modify the value of the selected parameter Press ENTER v to confirm the newly selected value When a parameter contains several setup fields such as Date and Time press ENTER WY to move from one field to the next If you do not conf
92. 9 Refer to the Dual Bag s instructions for further information z j T UUA IN q TH TEN 107A Figure 6 19 Using the Dual Bag Accessory 6 10 Mounting the Ventilator on the Utility Cart Match the mounting holes item 1 on the bottom of the Puritan Bennett 560 Ventilator to the mounting studs item 2 on the top of the utility cart platform 6 18 Puritan Bennett 560 Ventilator Clinician s Manual 6 11 Connecting the Nurse Call Cable Connecting the Nurse Call Cable Connect the Nurse Call cable Figure 6 20 item 1 to the Nurse Call Monitor Connector item 2 at ry a i a i O2 e 7 bi P INLET Figure 6 20 Connecting the Nurse Call Cable WARNING Before using the Nurse Call system ensure that its connections are secure and it operates properly For more information contact Covidien To connect the ventilator to a Nurse Call device contact Covidien to check the ventilator s compatibility with the Nurse Call device and order a suitable connection cable Before using the Nurse Call system ensure that its connections are secure and it operates properly Do not use Nurse Call devices that operate based on the closure of an electrical circuit because the devices often do not take into account possible cable disconnection or a total loss of power Ensure that the Nurse Call device is always connected to the ventilator Th
93. ACTION OF INSPIRED OXYGEN An FiO sensor connected to the patient circuit allows you to determine that the correct level of oxygen is being delivered to the patient Min and Max FiO thresholds can be set to trigger LOW FIO2 or HIGH FIO2 alarms Min and Max FiO thresholds are related and their settings must maintain a minimum difference of 10 between the two Min and Max FiO settings can be set to OFF if an FiO sensor is not connected Settings are automatically restored once a sensor is reconnected These settings are the same for all ventilation modes Puritan Bennett 560 Ventilator Clinician s Manual 3 13 Operating Parameters 3 4 VA C Mode Parameters and Setting Ranges The menus in the V A C Volume Assisted Controlled ventilation mode are shown in Figure 3 7 PB560C12 PB560C13 500 mL hh hee ee pe OFF z 30 mbar Min Current Max A 997mL B Be 427 me IP mbar PEEP 3mbar 13 bpm me Rate 11 bpm Myo 0 0L 1 2 0 R IE 4 2 4 VIE m 300 12 RX IE 14 24 2 m Fio 21 OFF MA Vol 0 0L o Preferences mbar gt o Alarms Logs Figure 3 7 Menus in the V A C Mode The ventilation parameters that are adjustable in the V A C mode are shown in Table 3 7 on page 3 14 Table 3 7 Ventilation Parameters in V A C Ventilation Mode Min Max Adjustment Default Value Value Resolution Value Linked Parameters Et PEEP cmH 0 mbar or hPa pe aaa 1 0 1 bot 50 1 33 a Ts
94. B 4 Performance B 4 1 Specifications Table B 8 Performance Parameter Specifications and Tolerances Settings Tolerances B 5 Monitored Parameters Table B 9 Monitored Parameter Specifications and Tolerances Peak Inspiratory Pressure PIP 0 to 99 mbar 2 mbar 8 Positive End Expiratory Pressure PEEP 0 to 99 mbar 2 mbar 8 Inspiratory Tidal Volume VTI 0 to 9999 ml 10 ml 10 VTI Rate Exhalation Tidal Volume VTE 20 to 9999 ml 10 ml 10 VTE VTE Total Breath Rate Rtot 0 to 99 bpm B 3 Puritan Bennett 560 Ventilator Clinician s Manual Specifications Table B 9 Monitored Parameter Specifications and Tolerances Continued E Ratio I E 9 9 1 to 1 9 9 50 ms or 10 whichever is greater I T Ratio I T 50 ms or 10 whichever is greater Inspiratory Minute Volume Min VI 0 to 99 9 10ml 10 Vt Sigh Vt x1 to Vtx 2 20ml 20 a The PB560 does not have the capability to reduce pressure below the PEEP pressure during the exhalation phase B 4 Puritan Bennett 560 Ventilator Clinician s Manual Specifications B 6 Range Resolution and Accuracy Table B 10 lists the ranges resolutions and accuracies for ventilator settings alarm settings and patient data Table B 10 Ventilator Range Resolution and Accuracy Ventilator Settings Range Resolution and Accuracy Mode Range V A C PA C V SIMV P SIMV PSV CPAP Resolution N A Accuracy N A Default
95. CPAP mode The device is configured with a default E Sens of 25 FIO2 Min and or Max Alarm Settings Fraction of Inspired Oxygen An FiO sensor connected to the patient circuit allows you to determine that the correct level of oxygen is being delivered to the patient Min and Max FiO thresholds can be set to trigger LOW FIO2 or HIGH FIO2 alarms Min FiO and Max FiO thresholds are related and their settings must maintain a minimum difference of 10 between the two Min and Max FiO settings can be set to OFF if an FiO sensor is not connected Settings are automatically restored once a sensor is reconnected These settings are the same for all ventilation modes 3 3 P A C Mode Parameters and Setting Ranges The menus in P A C Pressure Assisted Controlled ventilation mode are shown inFigure 3 5 PB560C10 PB560C11 a PAC ABS o PIP 15 mbar 90 oPEEP OFF 983 mL o Rise Time 2 i 429 mL A3bpm i 0 0L 1 2 0 A 29 bpm j 1 2 3 ovVtTarget OFF E 941 o Preferences mbar i o Alarms Lo gs Figure 3 5 Menus in P A C Mode with exhalation valve configuration PB560C10A PB560C11A o PC P A C ABS m PIP 15 mbar 90 r i OPEEP 4mbar mvt 1488 mL PIP 70mbar o Rise Time 2 1 BA Leak 0 0 Lpm o Rate 13 bpm me iiol 0 0L o LE 1 2 0 Rate 22bpm o I Sens OFF mic 4 2 0 ovVtTarget OFF _ io o Preferences Aa ae o Alarms Logs Figure 3 6 Menus in P A C Mode with leakage confi
96. DOWN E v arrows to adjust the setting between 5 and 62 seconds 4 Press ENTER G5 Note Values set in the ventilation mode may supercede disconnection alarm values Refer to chapter 5 Alarms and Troubleshooting 7 3 9 Waveforms Display To set Waveforms Display 1 Select the Waveforms Display parameter on the display 2 Select either e YES Displays pressure and flow waveforms as a function of time refer to section 4 3 Waveform Display e OFF Results in no waveform display hence no waveform menu 3 Confirm the new Waveforms Display setting before seven 7 seconds elapse The default setting for Waveforms Display is OFF The waveform screen on which the waveforms are displayed is accessed using MENU EH from the Alarm Setting menu This screen is available ONLY when ventilation is in progress Puritan Bennett 560 Ventilator Clinician s Manual 7 13 Operating Procedures 7 4 7 3 10 Pediatric Circuit To choose a pediatric circuit 1 Select the Pediatric Circuit parameter on the display 2 Select either e YES Selects a pediatric patient circuit e OFF Selects an adult patient circuit 3 Confirm the new patient circuit before seven 7 seconds elapse The default setting for Pediatric Circuit is OFF To set up the ventilator for a pediatric circuit 1 Use the UP g 4 or DOWN 6 v_ arrows to place the cursor at the Pediatric Circuit position 2 Press ENTER 3 Press UP 4
97. H 600 hPa to 1100 hPa 152 m to 3964 m TE 8 7 psi to 16 0 psi 500 ft to 13 000 ft Under extreme conditions of use that are beyond the recommendations above but within the limits of a supply voltage of 20 compared to the nominal temperature or the combination of a temperature of 45 C 113 F and humidity of 75 RH the ventilator should not malfunction nor endanger the user However operating the device for prolonged periods or repeatedly under such extreme conditions could result in premature aging of components and more frequent maintenance USB Table B 13 USB Memory Device Specifications USB compatibility USB flash memory USB 2 0 or USB 1 1 Memory file format USB 32 bit format sector size 512 2 048 bytes Number of files Maximum 999 Puritan Bennett 560 Ventilator Clinician s Manual Specifications B 9 B 10 B 9 Table B 14 Data Transfer Characteristics Trends capacity 86Mb Monitorings capacity 42 Mo 48 hours Pneumatic Table B 15 Airway Resistances inspirators emaon 1 0 mbar at 30 lpm flow 0 5 mbar at 30 lpm 3 7 mbar at 60 lpm flow 1 1 mbar at 60 lpm Table B 16 Patient Circuit Resistances Adult Double Limb Pediatric Double Limb lt 2 mbar at 60 lpm flow lt 2 mbar at 30 lpm flow a Includes exhalation valve b Values obtained from the manufacturer s directions for use Table B 17 Air Inlet Resistance Filter 0 057 mbar 0 0057 kPa at 24 lpm flow a All t
98. IP 145 mbar m PEEP OF o Rise Time 2 o Fate TF bpr 1 2 0 F OvVtTarget OFF o Preferences Figure 7 31 Stopping Ventilation 1 e While keeping the VENTILATION ON OFF O key pressed a new message appears that directs the user to release the key to stop ventilation shown in the graphic below PB560C66 oP T H ABS o PIP 5 mbar m FEEF OF o Rise Time 2 z D o Rate 13 bpm OE 1 2 0 o Sens F oOvtTarget OFF 4 STOF iL RELEASE FOR COMPLETE o Preferences Figure 7 32 Stopping Ventilation 2 e A double beep sounds 2 Release the VENTILATION ON OFF Q key e Ventilation stops 7 28 Puritan Bennett 560 Ventilator Clinician s Manual Turning Off the Ventilator e The blue LED located to the upper right of the VENTILATION ON OFF Q key Figure 7 30 item 2 illuminates to indicate ventilation is on Standby e A prompt for anew start of ventilation is displayed see Figure 7 29 on page 7 27 7 12 Turning Off the Ventilator WARNING When the ventilator is switched back on it will immediately begin ventilating without the user first hav ing to press the VENTILATION ON OFF f key Handle the ventilator with care after use particularly when ambient temperatures are high Some ventila tor surfaces may be very hot even if safety specifications are not exceeded Set the I O switch to the O position to power off the ventilator e The blue LED to the righ
99. LATION ON OFF button To reduce the risk of infection wash your hands thoroughly before and after handling the ventilator or its accessories A patient treated by mechanical ventilation is highly vulnerable to the risks of infection Dirty or contaminated equipment is a potential source of infection Clean the ventilator and its accessories regularly and systematically before and after each use and following any maintenance procedure to reduce the risks of infection The use of a bacterial filter at the ventilator s outlet or both ports if a double limb circuit is used is recommended Refer to chapter 9 Cleaning Handle the ventilator with care during and after use particularly when ambient temperatures are high Some ventilator surfaces may become hot even if safety specifications are not exceeded AN Warnings Regarding Installation and Environment of Use Even though the Puritan Bennett 560 Ventilator meets current safety standards the internal Lithium ion battery of the device exceeds the 100Wh threshold and is therefore considered to be Dangerous Goods DG Class 9 Miscellaneous when transported in commerce As such the Puritan Bennett 560 Ventilator and or the associated Lithium ion battery are subject to strict transport conditions under the Dangerous Goods Regulation for air transport IATA International Air Transport Association International Maritime Dangerous Goods code for sea and the European Agreement concer
100. NGE PRESS 5 9 5 17 Puritan Bennett 560 Ventilator Clinician s Manual CONTROLLED CYCLES 5 9 5 78 COOLING FAN 5 9 5 78 DC POWER DISCONNECTION 5 9 5 78 6 5 DEVICE FAULT 115 10 DEVICE FAULT10 5 70 5 178 DEVICE FAULT115 170 5 18 DEVICE FAULT12 5 70 5 18 DEVICE FAULT13 5 70 5 18 DEVICE FAULT3 5 9 5 718 DEVICE FAULT5 5 9 5 718 DEVICE FAULT7 5 9 5 178 DEVICE FAULT9 5 9 5 78 E SENS FAULT OR CIRC LEAK 5 70 5 19 EMPTY BATTERY 5 10 5 18 8 3 EXH VALVE LEAKAGE 5 10 5 19 FIO2 SENSOR MISSING 5 10 5 19 HIGH FIO2 5 10 5 19 HIGH INT TEMP COOL VENT 5 10 5 20 HIGH LEAKAGE 5 70 5 21 HIGH PRESSURE 5 77 5 217 HIGH RATE 5 77 5 22 HIGH VTE 5 11 5 21 HIGH VTI 5 11 5 21 HIGH LOW BATTERY TEMP 5 10 5 20 INSP FLOW 5 11 5 22 INTENTIONAL VENT STOP 5 72 5 22 KEYPAD FAULT 5 12 5 22 LOW BATTERY 1 4 5 12 5 22 8 3 LOW FIO2 5 12 5 22 LOW VTE 5 12 5 23 LOW VTI5 12 5 23 NO PROXIMAL LINE2 5 12 5 23 OCCLUSION CHECK CIRCUIT 5 12 5 24 PATIENT DISCONNECTION 5 73 5 24 POWER FAULT 5 13 5 24 POWER SUPPLY LOSS 5 13 5 24 PRES SENS FLT1 5 13 5 24 PROX SENS FLT2 5 13 5 24 REMOVE VALVE CPAP MODE 5 13 5 24 REMOVE VALVE OR CHANGE PRES 5 74 5 24 SOFTWARE VERSION ERROR 5 14 5 25 TURB OVERHEAT 5 14 5 25 UNKNOWN BATTERY 5 14 5 25 VALVE MISSING CONNECT VALVE 5 14 5 25 VTI NOT REACHED 5 14 5 25 Alarm parameters CPAP Mode Menu 3 7 P A C Mode Menu 3 10 P SIMV Mode Menu 3
101. P P SIMV and V SIMV modes Automatically clears itself after two successive patient breaths Ventilator has detected an internal battery fault Consequence the internal battery is disabled from use No internal battery detected Occurs when the buzzer battery is too low to sound the POWER SUPPLY LOSS alarm Defective operation of the buzzers Failure detected in the Very High Priority buzzer Consequence no audible alarm in case of POWER SUPPLY LOSS alarm Battery Charge Failure due to incorrect voltage Contact your service representative for assistance Yes except for CPAP Puritan Bennett 560 Ventilator Clinician s Manual Alarms and Troubleshooting Table 5 1 Overview of Alarms Continued Alarm Message BUZZER FAULT4 RESTART SRVC Cause Ventilator Response Buzzer Battery Failure The Battery Buzzer Voltage is too low Internal technical problem that prevents the battery sounding the POWER SUPPLY LOSS alarm Priority An FiO sensor is detected and CALIBRATION FAIL CHECK BATTERY CHARGE IF PERSISTS RESTART SRVC CHECK EXH VALVE IF PERSISTS RESTART SRVC CHECK EXH VALVE PRESSURE CHECK FIO2 SENSOR CHECK PROXIMAL LINE1 IF PERSISTS RESTART SRVC 5 8 Failure of one calibration point of the internal exhaled flow sensor Consequence failed calibration point is replaced by the default point Internal battery charging failure Consequence
102. POST routine and then return to Standby mode Preferences Menu Parameters The Preferences menu is only accessible if the Locking Key has not been enabled refer to section 7 8 Locking the Control Panel on page 7 25 and section 7 9 Unlocking the Control Panel on page 7 26 The Preferences menu is accessed from the Ventilation Parameters menu when ventilation is either on or Off WARNING Setting Alarm limits to extreme values can cause the ventilator alarms to malfunction Puritan Bennett 560 Ventilator Clinician s Manual Preferences Menu Parameters Note Default alarm setting preferences should be entered prior to using the ventilator 7 3 1 Preferences Menu To display the Preferences menu 1 Press DOWN y gt several times or continue to press DOWN v until the cursor is on the Preferences line as shown in the following graphic 2 Press ENTER WY The Preferences menu is displayed ape PB560C53 oP AIC ABS o PIP 15 mbar 90 oPEEP OFF ac seoneinising o Rise Time 72 x 434mL 13bpm 0 0L ie z 24bpm 2 z 1 2 1 ovtTarget OFF i 21 m Preferences mbar Figure 7 11 Selecting the Preferences Menu PREFERENCES reeuees o Backlight OFF o Contrast E n L o Alarm Volume SE o Key Sound OFF o Intentional Yent Stop YES o Apnea Alarm YES o Dis ectionalarm 15s o Display Waveforms YES o Pediatric circuit OFF o Ventilation Report m Back to Ventilat
103. PURITAN BENNETT 560 Copyright 2010 COVIDIEN Figure 7 2 Welcome Menu Screen If the ventilator had been previously stopped by use of the I O switch while ventilation was in progress the ventilator starts directly in ventilation mode and does not show the Welcome Menu screen The Alarm Technical Fault and Event logs are stored in non volatile memory on the Main CPU PCB ensuring that the information is retained when the ventilator is powered off and during power loss conditions Puritan Bennett 560 Ventilator Clinician s Manual 7 2 Setup Menu Parameters To skip the Welcome Menu e Press VENTILATION ON OFF to start ventilation immediately The Ventilation menu is then displayed PB560C51 ae PAC ABS o PIP 15 mbar oO PEEP OFF o Rise Time 72 re ch o Rate 13 bpm a o LE 4 2 0 ae TO START o Sens 2 ovtTarget OFF Me VENTILATION O Preferences rere Figure 7 3 Ventilation Menu Parameters By default the starting ventilation mode is the last one used the settings being those that were active when the machine was last stopped If the ventilator s memory of the settings is faulty a CHECK SETTINGS alarm is activated If this occurs the desired parameters should be reset and saved otherwise the machine will operate on default parameter values Setup Menu Parameters 7 2 1 Accessing Setup Configuration Note The Locking Key prevents access to the Setup menu refer to section
104. Parameters and Setting Ranges Min and Max FiO settings can be set to OFF if an FiO sensor is not connected Settings are automatically restored once a sensor is reconnected These settings are the same for all ventilation modes 3 2 CPAP Mode Parameters and Setting Ranges The menus in CPAP Continuous Positive Airway Pressure ventilation mode are shown below PB560C06 PB560C07 CPAP ABS o PEEP 10 mbar i o Apnea time AUTO a vtl 986 mL E Leak 0 0 Lpm BE iiio 0 0L Rate 24bpm ac 1 3 4 Ba Fi02 24 O Preferences mbar o Alarms Logs Figure 3 4 Menus in CPAP Mode in leakage configuration The ventilation parameters and setting ranges available in CPAP mode are listed in Table 3 3 Table 3 3 Ventilation Parameters in CPAP Menu Min Adjustment Default Es Value Max Value Resolution Value Es cmH 0 mbar or hPa a not available if Apnea Alarm is set to OFF in Preferences Menu Table 3 4 lists the available alarm settings in CPAP mode Table 3 4 Alarm Parameters in CPAP Mode Min Adjustment Linked Value Max Value Resolution Default Value Parameters im m s O w o s e mnro w e o O o S ore mro A N WARNING The CPAP mode does not feature control cycles Do not use this mode for ventilator dependent patients Note Puritan Bennett 560 Ventilator Clinician s Manual 3 7 Operating Parameters 3 8 Only leak configuration is available in CPAP mode PEEP
105. S line Refer to the following graphic ALARM LOGS AC POWER DISCONNECTION 01 jAN 09 12 05 am gw User s clear alerts o Back PB560C42 Figure 5 8 Alarm Logs 1 Press the ENTER WY key for at least three 3 seconds The following events occur e A beep sounds e An audible alarm sounds e An alarm indicator illuminates e The messages of all active alarms are displayed in a loop in the Ventilation and Alarm menus e The Audio Paused symbol disappears if it was displayed e The Alarm Paused symbol JX disappears 5 6 Puritan Bennett 560 Ventilator Clinician s Manual Alarms and Troubleshooting 5 7 5 7 Overview of Alarms Note The message IF PERSISTS RESTART SRVC will occur only if the alarm condition continues for longer than 30 seconds Table 5 1 Overview of Alarms Alarm Message AC POWER DISCONNECTION BATTERY FAULT1 RESTART SRVC BATTERY FAULT2 RESTART SRVC BUZZER LOW BATTERY BUZZER FAULT1 RESTART SRVC BUZZER FAULT2 RESTART SRVC BUZZER FAULT3 RESTART SRVC Cause Ventilator Response Cut off of the AC mains power supply Alarm activation occurs e After 5 seconds if ventilation is stopped At the start of a ventilation cycle when ventilation is in progress Consequence switch over to external DC power supply if present otherwise to the internal battery No inspiratory trigger detected by the ventilator after the apnea time set in PSV CPA
106. SIMV mode when Relative Pressure is set to YES Range 1 4 Resolution 1 Default value 2 Depends on Insp time Puritan Bennett 560 Ventilator Clinician s Manual Specifications Table B 10 Ventilator Range Resolution and Accuracy Continued Ventilator Settings Range Resolution and Accuracy Range OFF or 5 40 bpm Backup rate Apnea time Minimum Inspired Tidal Volume Min VTI Maximum Inspired Tidal Volume Max VTI Minimum Exhaled Tidal Volume Min VTE Maximum Exhaled Tidal Volume Max VTE Maximum Respiratory Rate Max Rtot Minimum Peak Inspiratory Pressure Min PIP Maximum Peak Inspiratory Pressure Max PIP Minimum inspiratory time Min time B 7 Resolution 1 bpm Default value 13 Depends on Min time In P SIMV and V SIMV Backup rate Max 8 R Rate Range AUTO or 1 60 s Resolution 1 s Default value AUTO Depends on Backup R In PSV Apnea time AUTO 60 Backup R In V SIMV or P SIMV Apnea Time AUTO 12 In CPAP Apnea Time AUTO 30 Range 30 mL to 1990mL Resolution 10 mL Default value 300 Depends on Max VTI Range 80 mL to 3000 mL Resolution 10 mL Default value 2000 mL Depends on Min VTI Range 30 mL to 1990 mL Resolution 10 mL Default value 300 Depends on Max VTE Range 80 mL to 3000 mL Resolution 10 mL Default value 1000 Depends on Min VTE Range 10 bpm to 70 bpm Resolution 1 bpm Default value OFF Depends o
107. SISTS RESTART SRVC OCCLUSION CHECK CIRCUIT Cause Ventilator Response Ventilation has been stopped voluntarily by the caregiver or patient Keyboard key held down for more than 45 seconds Internal battery capacity lt 30 min or 8 The level of oxygen delivered by the ventilator is below the Min FiO level set Expired tidal volume less than Min VTE set during three consecutive breaths in double limb setup Alarm activation occurs e After three consecutive breaths Inspired tidal volume less than Min VTI set during three consecutive breaths in PSV CPAP P A C P SIMV and V SIMV modes Alarm activation occurs e After three consecutive breaths Proximal pressure lt 0 6 mbar for 100 ms during inspiration phase of 3 breath cycle Ventilator response Switch to internal pressure sensor for pressure measurement Tidal volume measured negligible during three consecutive breaths for PSV CPAP P A C and P SIMV modes Alarm activation occurs e After three consecutive breaths Occurs in LEAK configuration when the LEAK level is not sufficient to flush the CO from patient exhalation The built in LEAK in the mask may be obstructed The built in leak for the mask is or not sufficient for the settings l Puritan Bennett 560 Ventilator Clinician s Manual Alarms and Troubleshooting Table 5 1 Overview of Alarms Continued Alarm Message Cause Ventilator Response
108. Time defaults to a setting equal to RISE TIME 300 ms and the Max Time defaults to the lesser of 3 seconds or 30 Rate Ramp The distribution shape or flow pattern of the flow rate during the inspiratory phase cannot be set in V SIMV mode The device is configured by default with a square wave flow pattern that represents a constant flow rate sQ Rise Time The Rise Time during the inspiratory phase can be set in V SIMV mode and the range is 1 5 The ventilator has a default Rise Time of 2 or a pressure rise time of 400 ms E Sens EXHALATION SENSITIVITY E Sens is available in the P SIMV V SIMV and PSV mode E Sens allows you to determine sensitivity of switching to exhalation and thus indirectly determines the inspiratory time of a breath The end of inspiration will occur when Inspiratory Flow has decreased to the preset E Sens setting The exhalation trigger is only taken into account after the Rise Time which constitutes a default minimum inspiratory time has elapsed If the flow drop is insufficient exhalation is automatically triggered independently of the E Sens which is defined as a percentage of peak inspiratory flow Exhalation may be triggered if the maximum inspiratory time of three 3 seconds has elapsed which corresponds to an I E Ratio of 1 1 0 to ensure that the patient has enough time to exhale Note Refer to chapter 7 Operating Procedures for positive and negative E Sens settings Puritan Benne
109. USB MeNnu cece cece cece cece teen eee eeeeeeeeeeeeeeees 7 22 Selecting Transfer Continuously a i500 d05sd2e4G40044e0 paaw ese rdameenwteean dane 7 23 Selecting Transfer Trends sii ws ssivedeveievesneenesadedstedeaasvasiesdaeseiesd s 7 24 Erasing Data from the USB Memory Device cece cece eee een eeeennes 7 25 Puritan Bennett 560 Ventilator Clinician s Manual Figure 7 28 Installing the LOCKING Key 220 icc2 dcnnisaseedvdcdsvaseweetetewetadeed cncdedad aces 7 26 Figure 7 29 Prompt to Start Ventilation xia iceosenedesnswee andes eawsninann send beaded sdeemens 7 27 Figure 7 30 Starting Ventilation 0 ccc ccc ccc cece cece cece eee e eee eee eeeeeeeeeeeees 7 27 Figure 7 31 Stopping Ventilation 1 s sciciriesicdedanesoeedawe nes swad ewer iwiedaparedenaw ends 7 28 Figure 7 32 St pping Ventilation 2 ecesdetctcccuduewesesieceaasaneeon deus d iou akd aante 7 28 Figure 8 1 Internal Battery Indicator 0 ccc ccc ccc cece eee eee n enna eee eneneees 8 2 Figure 8 2 Battery Reserve Capacity as a Percentage 1 eo ccc cece eee reece ee eeeeees 8 3 Figure 8 3 Battery Reserve Capacity in Hours and Minutes ccc cee cece eee eeeeees 8 3 Figure 8 4 Power Indicators When Charging the Battery ccc cece e cece eee ee eeenes 8 4 Figure 10 1 Blocking the Patient Wye Double Limb Circuit Shown c cece ewes 10 1 Figure 10 2 Calibrating the Exhalation Flow Sens
110. Unpacking and Preparation The Puritan Bennett 560 Ventilator is delivered with the following items 1 Printed User s Manual language as requested by the customer 1 Clinician s Manual on CD a print copy is available upon request by the customer 1 1 Patient circuit and valve 1 Carrying bag 1 Oxygen connector Set of six 6 combination foam fine particle air inlet filters 1 AC power cable JN WARNING Users must always possess an additional circuit and valve while using the Puritan Bennett 560 Ventilator To minimise the risk of damage you must use the Dual Bag to transport the Puritan Bennett 560 Ventilator Refer to Figure G 2 To unpack and prepare the ventilator follow the steps below 1 From the plastic bag remove the following e Plastic pocket containing the Clinician s Manual e The ventilator and its components and or accessories 2 Remove the patient circuit the AC Mains power cable and the set of fine particle air inlet filters 3 Inspect the ventilator and ensure that e the ventilator s outer casing and the I O switch s protective cover do not have any dents or scratches which may indicate possible damage e the ventilator s labels and markings are clear and legible e the AC power cable does exhibit any signs of damage such as kinks breaks or cuts WARNING Never use a ventilator or any components or accessories that appear
111. VENTILATOR ON OFF key flash Ensure also that the two alarm buzzers sound 7 Perform the Functioning Alarms Test refer to Appendix F Alarms Tests Check Verify the alarm volume is adapted to the patient environment Refer to section 7 3 Preferences Menu Parameters on page 7 8 for instructions on changing the alarm volume setting Ensure the patient breathing circuit is correctly attached to the ventilator with all the necessary components and is free from any signs of damage and leaks If exhaled volume monitoring is required use the double limb circuit for exhaled tidal volume monitoring Puritan Bennett 560 Ventilator Clinician s Manual E 1 Operational Verification Checklist This page intentionally blank E 2 Puritan Bennett 560 Ventilator Clinician s Manual Low Pressure Test F Alarms Tests Before connecting the ventilator to the patient perform the following tests to ensure the ventilator s alarms are working properly nN WARNING Do not perform ventilator alarm tests while the patient is connected to the ventilator Provide the patient with an alternate means of ventilation before conducting these tests If the ventilator fails any alarm test or if you cannot complete these tests see the Troubleshooting section refer to chapter 5 Alarms and Troubleshooting of this manual or call your equipment supplier or Covidien refer to section 10 5 Service Assistance on page 10
112. Y LOSS alarm from triggering BUZZER FAULT2 RESTART SRVC BUZZER FAULT3 technical h RESTART SRVC nternal technical problem that prevents the battery from correctly charging Internal technical problem that prevents the battery warning buzzer from sounding POWER SUPPLY LOSS alarm BUZZER FAULT4 RESTART SRVC Buzzer battery is too low to sound POWER BUZZER LOW BATTERY SUPPLY LOSS alarm Restart ventilator to see if alarm clears If not replace the ventilator and call your customer service representative Restart ventilator to see if alarm clears If not replace the ventilator and call your customer service representative Ensure that the protective cover over the I O switch located on the rear of the device is intact and functioning properly This cover helps prevent accidental pressing of the I O switch and stoppage of the ventilation Ensure that the device is stabilised Call your customer service representative Restart ventilator to see if alarm clears If not replace the ventilator and call your customer service representative Connect the ventilator to AC power and switch on the device using the on off at the rear of the ventilator I O Leave to charge for at least 15 minutes If persists restart ventilator to see if alarm clears If not replace the ventilator and call your customer service representative Connect the ventilator to AC power and switch on the device using the on off at
113. ables a HIGH LEAKAGE alarm to be triggered in the event the calculated leakage flow exceeds this limit The displayed value corresponds to the mean parasite leakage flow observed during the exhalation phase Max Leak is displayed when ventilating without an exhalation valve Setting the Max Leak is not mandatory it can be set to OFF but the measured value is always displayed Max Rtot Max Alarm Setting TOTAL BREATH RATE The maximum rate threshold set is used to warn of hyperventilation or ventilator autotriggering The alarm setting is used to trigger the HIGH RATE alarm Refer to chapter 5 Alarms and Troubleshooting When set the Max Rtot threshold must always exceed the Backup Rate by 5 bpm If the Backup Rate is readjusted the Max Rtot is automatically readjusted to maintain a minimum difference of 5 bpm Setting the Max Rtot is not mandatory it can be set to OFF but the measured value is always displayed FiO Min and or Max Alarm Settings FRACTION OF INSPIRED OXYGEN An FiO sensor connected to the patient circuit allows you to determine that the correct level of oxygen is being delivered to the patient Min and Max FiO thresholds can be set to trigger LOW FIO2 or HIGH FIO2 alarms Min FiO and Max FiO thresholds are related and their settings must maintain a minimum difference of 10 between the two Puritan Bennett 560 Ventilator Clinician s Manual CPAP Mode
114. al 1 5 Safety Information 1 6 To connect the ventilator to a Nurse Call device contact Covidien to check the ventilator s compatibility with the Nurse Call device and order a suitable connection cable Do not use Nurse Call devices that operate based on the closure of an electrical circuit because the devices often do not take into account possible cable disconnection or a total loss of power Ensure that the Nurse Call device is always connected to the ventilator Warnings Regarding Settings Before starting ventilation always verify that all settings are properly set in accordance with the required prescription Before starting ventilation ensure that the device is properly assembled and that the air inlet cooling vents and alarm sound diffusion holes are not obstructed Ensure also that the patient circuit is of the proper configuration double or single limb properly connected to the ventilator and that the circuit hoses are neither damaged nor compressed and contain no obstructions or foreign bodies The CPAP mode does not provide a set respiratory rate Do not use this mode for ventilator dependent patients Do not allow a patient to remain connected to the ventilator when ventilation is stopped because a substantial quantity of exhalation gas primarily carbon dioxide may be inhaled by the patient Alarm volume should be adjusted with respect to the ventilator s operating environment and so that the patient s caretak
115. alarms is currently disabled For more information refer to section 5 4 Silencing the Audible Portion of Alarms Alarm Paused reset cancelled This symbol means one or more alarms have been paused or reset cancelled For more information refer to section 5 5 Pausing Resetting Alarms Apnea Alarm Deactivated This symbol means that the Apnea Alarm has been deactivated For more information refer to section 5 5 Pausing Resetting Alarms Exhalation Valve detected This symbol means that an exhalation valve has been detected during ventilation 1 12 Puritan Bennett 560 Ventilator Clinician s Manual Labels Identification and Instruction Information Table 1 1 Ventilator Symbols No Exhalation Valve detected This symbol means that no exhalation valve has been detected during ventilation Single patient use only ISO 7000 1051 This symbol means that the labeled device is for use by a single patient only Freeze Waveforms This symbol means the tracing of patient pressure and flow waveforms is currently paused or frozen For more information refer to section 4 3 Waveform Display Follow instructions for use ISO 7000 1641 This symbol directs the user to observe and adhere to the instructions contained in the product s user manuals USB port This symbol indicates a communications port for interfacing with a USB connector See Figure 2 2 item 11 PC connector This sym
116. ameters Two possibilities exist in this case e Allow the PEEP setting to remain at 20 but the P Support cannot be increased e Reduce PEEP so that the P Support setting can be set higher than 35 to ensure that their sum is no greater than 55 7 5 2 Links between Ventilation and Alarm Parameters Setting a ventilation parameter takes priority over an alarm threshold setting and leads to automatic readjustment of the alarm setting threshold so that the interdependence between the two remains unchanged Once the ventilator is in service at the patient s home you should use the Locking Key to block access to changing any settings see section 7 8 Locking the Control Panel on page 7 25 7 6 Setting Alarm Parameters Alarm parameters can be changed from the Alarm menu if the Locking Key is not enabled refer to section 7 8 Locking the Control Panel on page 7 25 and section 7 9 Unlocking the Control Panel on page 7 26 Note e Adjustable alarms should not be systematically cancelled they should be adjusted according to the needs and condition of the patient e Default alarm setting preferences should be entered prior to using the ventilator To modify an Alarm Parameter 1 Ensure that the Alarm menu is displayed showing a list of alarm parameters and columns for the minimum current and maximum alarm parameter values Figure 7 22 on page 7 20 Puritan Bennett 560 Ventilator Clinician s Manual 7 19
117. an alarm if the Tidal volume inspired by the patient is lower than the minimum threshold set LOW VTI alarm or greater than the maximum threshold set HIGH VTI alarm Refer to chapter 5 Alarms and Troubleshooting Min VTI and Max VTI are related and their settings must be set to values that maintain a minimum difference of 20 ml between the two It is not mandatory to set the minimum and maximum VTI alarm limits When the minimum and maximum VTI alarm limits are not set the display will read OFF for these settings VTE Min and or Max Alarm Settings EXHALATION TIDAL VOLUME Use a double limb patient circuit configuration when setting the minimum and or maximum Exhalation Tidal Volume alarm parameters These thresholds can be set to trigger an alarm if the Tidal volume expired by the patient is lower than the minimum threshold set LOW VTE alarm or greater than the maximum threshold set HIGH VTE alarm Refer to chapter 5 Alarms and Troubleshooting Min VTE and Max VTE are related and their settings must be set to values that maintain a minimum difference of 20 ml between the two VTE is displayed when ventilating with an exhalation valve It is not mandatory to set the minimum and maximum VTE alarm limits When the minimum and maximum VTE alarm limits are not set the display will read OFF for these settings Max Leak Max Alarm Settings The setting of a high leakage threshold en
118. an check them RESTART SERV time is not long enough to deliver set VT Increase time or decrease VT 5 8 2 Additional Troubleshooting Table 5 3 provides other possible ventilator problems causes and corrective actions Z WARNING If the device is damaged its external housing is not correctly closed or it behaves in a way that is not described in this manual excessive noise heat emission unusual odour alarms not triggered during the start up procedure the oxygen and power supplies should be disconnected and use of the device stopped immediately If you cannot determine the cause of the problem contact your equipment supplier Do not use the ventilator until the problem has been corrected Note Buzzer and battery alarms may occur when the unit is first powered on after the internal battery has been completely drained Connect to an AC power source and recycle power Table 5 3 Additional Troubleshooting and Corrective Actions Conditions Possible Causes Corrective Actions Set Display waveform to YES in Preferences menu refer to section 7 3 Preferences Menu Parameters No access to the Display waveform set to NO in waveforms Preferences menu The screen backlight never Switches off during ventilation Set Backlight to YES in Preferences menu Backlight set to NO in Preferences menu refer to section 7 3 Preferences Menu Parameters Adjustment of the alarm sound level is incompatible with
119. and is proportionally controlled during the exhalation phase to obtain the bias flow The speed of the turbine adapts to the exhalation pressure threshold during the entire exhalation phase to maintain the operator set PEEP The flow measurement completes the system by enabling detection of patient inspiratory effort and the triggering of inspiration phases The flow measurement can also be used to determine the end of the inspiration phase in certain ventilation modes The flow measurement is automatically corrected as a function of the atmospheric pressure measured inside the ventilator with the Altitude Compensation feature The flow and volume are in Body Temperature Pressure Saturated BTPS conditions This necessitates that periodic inspections for calibrating the sensors be performed by maintenance technicians authorised by Covidien refer to the Puritan Bennett 560 Ventilator Service Manual If the Altitude Compensation feature is active a corrective algorithm is applied to the inspiration and exhalation flow for volume calculation and the flow set point in volume breath 1 The Altitude Compensation feature is enabled set to YES on the Setup Screen by default and should remain at this setting Puritan Bennett 560 Ventilator Clinician s Manual C 1 Theory of Operation The sensor measurement range is software limited from 600 to 1100 hpa A cooling fan is provided to maintain the internal temperature of the ventilat
120. aneous breaths In this configuration P Support and PEEP are related and their settings must maintain a minimum difference between the two of 2 mbar in leak configuration and 5 mbar in valve configuration PEEP POSITIVE END EXPIRATORY PRESSURE PEEP allows you to determine the level of pressure maintained during the exhalation phase When Relative Pressure is set to YES in the Setup Menu the sum of P Control or P Support and PEEP must not exceed 55 mbar When relative pressure is set to OFF P Control or P Support and PEEP are related and their settings must maintain a minimum difference between the two of 2 mbar in leak configuration and 5 mbar in valve configuration The ventilation mode can be adjusted without PEEP PEEP is nearly 0 mbar when set to OFF in valve configuration In leak configuration the minimum PEEP setting is 4 mbar Rate RESPIRATORY RATE R Rate is the rate at which the ventilator control pressure cycles are initiated excluding apnea phases Rate and Insp Time are related so that if Rate is greater than 12 bpm then Insp Time must be between 20 and 80 of the breath cycle duration as determined by Rate Insp Time lt 0 33 x 60 R Rate if Rate gt 8 Insp Time lt 2 4 if Rate lt 8 Puritan Bennett 560 Ventilator Clinician s Manual 3 19 Operating Parameters Note e During apnea ventilation the ventilator delivers controlled breaths according to a backup rate Backup R as long as no
121. applicable RF compliance level above the Puritan Bennett 560 Ventilator should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the Puritan Bennett 560 Ventilator d Over the frequency range 150 kHz to 80 MHz field strengths should be less than 10 V m Table B 23 Recommended Separation Distances The ventilator is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the ventilator can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the ventilator as recommended below according to the maximum output power of the communications equipment Separation Distance According to Frequency of Transmitter 150 kHz to 80 MHz 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz outside ISM bands in ISM bands d 0 35 yP d 1 2 yP d 1 2 yP d 2 3 yP Rated Maximum Output Power of Transmitter W For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres m can be determined using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer Note At 80 MHz and 800 MHz the separation distance
122. applied part IEC 60417 5333 A regulatory standard classification for protection against electrical shock for the part of the device that contacts the patient This symbol appears on the ventilator s back panel see Table 1 2 item 5 Direct current DC IEC 60417 5031 This symbol appears on the ventilator s back panel see Figure 1 4 item 9 Alternating current AC IEC 60417 5032 This symbol appears on the ventilator s back panel and keyboard see Figure 1 4 item 8 and Figure 2 2 on page 2 5 item 10 Internal Battery This symbol appears on the ventilator s keyboard see Figure 2 3 on page 2 6 item 10 Insulation class Il equipment IEC 60417 5172 A regulatory standard classification for protection against electric shock Class Il equipment relies on double insulation rather than protective earthing This symbol appears on the ventilator s back panel see Table 1 2 item 5 Index of Protection rating for the ventilator s enclosure defined in IEC 60529 BSEN60529 1991 The first digit 3 indicates protection against the intrusion of small foreign bodies including fingers tools wires etc with a diameter greater than 2 5 mm into the ventilator The second digit 1 indicates protection against water dripping or falling vertically as well as an environment featuring water vapour condensation and or light rain This rating appears on the ventilator s back panel see Table 1 2 item 5 CSA Canadian Sta
123. are terminated by time E SENS FAULT OR CIRC LEAK Internal battery capacity lt 10min or 3 battery voltage lt 22 5V Consequence ventilation comes to a halt EMPTY BATTERY Abnormally high expired flow EXH VALVE during the inspiratory phase of LEAKAGE three consecutive breaths in double limb setup Alarm activation occurs After three consecutive breaths No FiO sensor detected and the FIO2 SENSOR FiO alarm is active MISSING HIGH LOW BATTERY TEMP IF PERSISTS Consequence battery charging RESTART SRVC stops The level of oxygen delivered by pone the ventilator exceeds the Max Yes No FIO2 level set Device internal ambient HIGH INT TEMP temperature out of tolerance COOL VENT range IF PERSISTS RESTART SRVC Battery temperature out of tolerance Yes Yes The LEAK estimated by the ventilator exceeds the Max LEAK Yes No alarm threshold HIGH LEAKAGE 5 10 Puritan Bennett 560 Ventilator Clinician s Manual Alarms and Troubleshooting Table 5 1 Overview of Alarms Continued Alarm Message Cause Ventilator Response In VA C or V SIMV modes if Inspiratory Pressure is higher than Max PIP during three consecutive cycles or In PSV CPAP P A C or P SIMV modes if Inspiratory Pressure is higher than P Support or P Control PEEP 5 mbar up to 29 mbar or 10 mbar over 30 mbar during three HIGH PRESSURE consecutive cycles or In PSV or CPAP mode and P Suppo
124. are not compatible ventilation with less than 5 mbar of REMOVE VALVE OR with the type of patient circuit used difference between PEEP and PIP or CHANGE PRES Increase the difference between PEEP and PIP to a minimum of 5 mbar The ventilation settings are not compatible Remove exhalation valve to start CPAP REMOVE VALVE with the type of patient circuit used ventilation CPAP MODE 5 24 Puritan Bennett 560 Ventilator Clinician s Manual Alarms and Troubleshooting Table 5 2 Alarms and Corrective Actions Continued Alarm Message or Possible Reason s For The Alarm Event Corrective Action s Symptom SOFTWARE VERSION Incorrect software version detected Call your customer service representative ERROR Ensure lateral and front openings are not obstructed TURB OVERHEAT Turbine overheated because of blockage Check air inlet filter RESTART SRVC during operation Restart ventilator to see if alarm clears If not replace the ventilator and call your customer service representative Internal battery not recognised as a l UNKNOWN BATTERY Puritan Bennett product battery Call your customer service representative The ventilation settings are not compatible Connect exhalation valve VALVE MISSING with the type of patient circuit used CONNECT VALVE oe ee Restart ventilator to see if alarm clears If VTI NOT REACHED a flow sensor or internal not replace the defective device s and IF PERSISTS have a skilled technici
125. arm parameter is not set to OFF but the ventilation parameter change has no impact on the alarm setting A N WARNING The level of inspiratory resistance of the circuit and accessories bacteria filter humidifier must be as low as possible Settings particularly the PATIENT DISCONNECTION alarm maximum inspired volume Max VTI and minimum inspired volume Min VTI settings must be periodically adjusted according to changes in the patient circuit resistance especially when filters are replaced Adjustable alarms should not be systematically cancelled instead they should be adjusted according to the needs and condition of the patient 7 7 USB Menu Parameters The USB menu is accessible even if the Locking Key has been enabled refer to section 7 8 Locking the Control Panel on page 7 25 and section 7 9 Unlocking the Control Panel on page 7 26 The USB menu is automatically displayed when the USB memory device is connected to the ventilator when ventilation is either on or off Only one USB memory device shall be connected at any time otherwise an error message will be displayed The USB Menu is not accessible from the Setup Menu or Maintenance menu Puritan Bennett 560 Ventilator Clinician s Manual 7 21 Operating Procedures 7 22 To access patent data via a PC a dedicated software package Puritan Bennett respiratory insight software is available for Clinicians Contact Covidien or your Puritan Benne
126. as measured from the ventilator outlet to the ventilator inlet is 1 1 metres 3 6 feet to 2 0 metres 6 6 feet The tubing must conform to all applicable standards and must be fitted with 22 mm terminals that also conform to all applicable standards Ensure that both the length and the internal volume of the patient circuit are appropriate for the tidal volume a corrugated tube of 22 mm for adult patients and a corrugated tube of 15 mm for pediatric patients with a tidal volume lower than 200 ml Adding accessories to the ventilator breathing circuit such as a humidifier and water trap s may result in a decrease in tidal volume delivered to the patient due to the added compressible volume of the accessory Always assure that the patient is receiving the appropriate inspired volume when altering the breathing circuit configuration Users must always possess an additional breathing circuit and exhalation valve while using the Puritan Bennett 560 Ventilator 6 4 1 Choosing the Patient Circuit Type Single limb circuits are used with breathing modes where spirometry measurements are not required and double limb circuits are used with breathing modes where spirometry is required Be sure to choose the appropriate circuit in the menu preferences in particular ensure that Pediatric Circuit Yes No is set to YES when using a pediatric circuit refer to Appendix H Parts and Accessories For information regarding validated circuits
127. aths both machine and spontaneous delivered by a ventilator in one minute Caregiver An individual who assists a patient with the tasks of daily living This may be a family member a live in assistant or the nursing staff of a health care facility cmH 0 An abbreviation for centimetres of water which is a unit of measure for pressure CPAP Continuous Positive Airway Pressure Continuous airway pressure maintained throughout a spontaneous breath cycle Controlled breath A volume or pressure breath triggered controlled and terminated by the ventilator DC Power Direct current Double Limb Patient Circuit Patient circuit with a tube between the ventilator gas outlet and the patient for inspiratory gas and another tube between the patient and the exhalation block for exhalation gas Exhalation Block Part of the ventilator that allows the connection of the exhalation limb of the patient circuit The exhalation block is for single patient use only Exhalation Phase Phase of the breath cycle during which the patient exhales Exhaled Tidal Volume VTE Exhaled volume measured for all breath types through the exhalation block Monitored value available only with double limb patient circuit Exhalation Sensitivity The exhalation sensitivity E Sens level is a percentage of peak flow at which a pressure supported breath will be terminated Exhalation Tidal Volume VTE Volume exhaled by the patient at each exha
128. ation Refer to section B 10 Manufacturer s Declaration on page B 9 The ventilator must not use nor be connected to any anti static or electrically conductive hoses tubing or conduits Connecting to External AC Power Any of four power sources AC power 12 30 VDC power Internal Battery power or Auxiliary DC car adapter cigarette lighter can be used to power the ventilator But when AC power is available the ventilator will automatically select AC power as its operating power source AN WARNING The power supply to which the ventilator is connected both AC and DC must comply with all current and applicable standards and provide electrical power corresponding to the voltage characteristics inscribed on the rear of the ventilator to ensure correct operation Ensure that the AC power cable is in perfect condition and not compressed The device should not be turned on if the AC power cable is damaged Connect the external electrical power source by first connecting the power cable to the ventilator and then to the external power source Follow the reverse procedure to disconnect the device from electrical power sources Do not leave power cables lying on the ground where they may pose a hazard To prevent accidental disconnection of the AC power cable use the power cable holder Figure 6 1 item 1 that is inserted into the notch Figure 6 1 item 2 of the battery cover AC Power Cable Holder SAATI I ALAA LM
129. ator applies a clinician set pressure Pressure Support to each of the patient s breaths This has the same benefits as CPAP with the additional benefit of assisting the patient in moving gas into his or her lungs Puritan Bennett 560 Ventilator Clinician s Manual D 1 Modes and Breath Types D 2 D 2 Breath Types Breath types available from the ventilator are e Volume controlled breaths in Assist Control mode in V A C or V SIMV e Pressure controlled breaths in Assist Control mode in P A C or P SIMV e Pressure supported breaths in SIMV mode V SIMV and P SIMV or PSV e CPAP D 2 1 Volume Breaths in Assist Control Mode In V A C each delivered breath will be of the selected volume Vt delivered over the selected inspiratory time calculated with R Rate and I E I T ratio Inspiration is triggered by patient generated flow for assisted breaths or by the ventilator For controlled breaths breath rate R Rate is the controlling parameter For both controlled and assisted breaths the inspiration is limited by the volume and is cycled by inspiratory time Insp Time The shape of the flow waveform can be either a decelerated D a SQ square or sinusoidal S flow patterns according to the Flow Pattern setting Start of Inspiration End of Inspiration Start of Inspiration End of Inspiration Airway Airway Pressure Pressure Flow Flow
130. atory pressure is limited to the pressure P Control setting and is cycled by time The shape of the pressure waveform depends on the setting of the pressure rise time Rise Time Start of Inspiration End of Inspiration Start of Inspiration End of Inspiration l l Airway i Airway Pressure Pressure Flow Flow Time Time P A C mode guarantees a maximum period between breaths as determined by the Breath Rate setting In the next waveform shown on the following page the ventilator delivers a controlled machine breath and calculates the time before another controlled breath must be delivered The ventilator delivers a second controlled breath at the conclusion of the machine calculated breath time for simplicity we will use the term period for machine calculated breath time Following the second controlled breath but before another period can elapse the patient s effort triggers an assisted or patient initiated breath This restarts the period At the conclusion of the period the ventilator delivers another controlled breath Period Period Period Airway Pressure Machine breath Machine breath Patient Initiated Breath Machine breath Time Puritan Bennett 560 Ventilator Clinician s Manual D 3 Modes and Breath Types D 4 D 2 3 Volume Breaths in V SIMV Mode In V SIMV the mandatory volume breaths deliver the selected volume Vt
131. be of 15 mm for pediatric patients with a tidal volume lower than 200 ml Table H 2 List of Circuits Description Part Number DAR Double limb patient circuit with exhalation valve 180 5094000 cm PVC ADULT DAR Double limb patient circuit with exhalation valve 180 5093900 cm PVC PEDIATRIC DAR Single limb patient circuit with exhalation valve 180 5093600 cm PVC ADULT DAR Single limb patient circuit with exhalation valve 180 5093500 cm PVC PEDIATRIC DAR Single limb patient circuit without exhalation valve 5093300 180 cm PVC ADULT DAR Single limb patient circuit without exhalation valve 5093100 180 cm PVC PEDIATRIC For more information regarding parts and accessories for the Puritan Bennett 560 Ventilator contact your service representative or www puritanbennett com H 2 Puritan Bennett 560 Ventilator Clinician s Manual Glossary AC Power Alternating current Alarm Pause The audible and visual alarms cease and the ZX symbol appears The symbol will remain until the cause of the alarm is addressed For example when the ventilator is running on internal battery the AC Disconnection alarm may be paused and the alarm paused symbol will appear until the device is plugged into AC The paused alarm will be captured in the alarm log screen and can be reactivated Alarm Reset Used only for the High Pressure alarm this function resets the visual alarm message Apnea The absence of breathing
132. bol indicates a port that can be used by authorised Puritan Bennett product service personnel or Covidien service personnel for software maintenance See Figure 2 2 item 10 Atmospheric pressure limitation Humidity limitations Temperature limitations Fragile Keep dry Keep away from direct sunlight Keep aay fron sunlaght jj t This side up This side up 1 4 Labels Identification and Instruction Information Various labels or specific markings are affixed to the ventilator that describe precautions to be taken for the cor rect use of the ventilator and contribute to the traceability of the product Refer to Table 1 2 and the figures on the following pages for illustrations of these labels and markings and their locations on the ventilator Use the item numbers in the following tables to locate the labels in Figure 1 1 to Figure 1 4 Puritan Bennett 560 Ventilator Clinician s Manual 1 13 Safety Information Table 1 2 Ventilator Labels and Markings 1 Patient Gas Inlet Label Figure 1 1 Figure 1 4 4 From Patient Port Exhalation Limb Connection of Patient Cir cuit Single Use Exhalation Block Label Figure 1 1 Figure 1 2 Figure 1 4 Ea COVIDIEN Puritan Bennett 560 Ventilator 5n w TC ECIREP Taci heakicam LIF Liri Baki St Tarchi STORAGE Calapan Harrah Pl Gee UE Tipe Heitia wis hae up LP Melber Pur went herera Cert ware or ochonchs Dekar tamaai A triin iri blaaie br
133. c cece eee eee ee 6 9 Pil WMG FINCY anew naetaceeetasanecemese coueeenacsesee eet qbascs aeeesecusesasseaues 6 11 Bacteria FING su rerccecscacegucet ac busetantieetecetacdabasueeeseeasacuerasueas ens 6 11 man E 4440 credvaadotcacarasas aurcineiwenascnarengandeauadenadeweadeneneaa cede 6 12 Removing the Exhalation BIOCK vss a0 isn0005s snde n cuss deed Pa eeee esse ee wan wess 6 13 Rear Panel Oxygen Connector os lt s20ceenewsnsecectaeaesscestadtaretiwessence ces 6 15 Connecting the Oxygen Supply SysteM ccc cece cece eee e eee eeeeeeeees 6 15 Disconnecting the Oxygen Supply System ccc cece eee ence eee e eens 6 16 Connecting the FiO2 sensor ny csarccco arene ees Rees ou ager gss ened ada yaks 6 17 Using the Dual Bag Accessory 22 cx scs0cia0ccestesedaseivedicadivadavedeceebena ba 6 18 Connecting the Nurse Call Cable 15250 ss00ssu0d coueeade Gand dxekerwncaens ewan news 6 19 T rning on the Ventilator ances crakennewecusonnns aenen ud haute gaaeaaweds eeaane dans 7 2 Welcome Menu Screen 2454240245 4ecsunenaadcdneanss ene teadteet neeonesedwaanenex 7 2 Ventilation Menu Parameters ccc ccc cece cece cece e eee e eee ee eeeeneenees 7 3 DELO WICH 4 aa vs cacti eh ata ec eTEN ENEN eee es oat eNsaow EN SONS Ara 7 3 Absolute and Relative PresSul iv 00 ss0sddeuesewdstieeiGaubiesscuedevaneasd ev eecs 7 6 E SENS SEWING Ss a as tae ene EErEE NEEE ATRAN EE enue eens amaenire EA AREENA 7 6 Resetting Patient Hours to Zero 1 0
134. cable and the DC power cable if it is connected from the ventilator e aPOWER DISCONNECTION alarm will trigger 2 Press the ALARM CONTROL key twice to pause the alarm Ensure that the following events occur e the INTERNAL BATTERY indicator to the upper left of the display illuminates e the BATTERY fj symbol is displayed at the top of the screen along with its reserve capacity 3 Connect the AC mains power supply Ensure that the following events occur e the AC POWER indicator to the upper left of the display illuminates e the indicator to the upper left of the display is flashing which indicates that the battery is charging this only occurs if the ventilator has run on battery power long enough to lose enough charge that the charger will turn on e the BATTERY f to the upper left of the display symbol is no longer displayed at the top of the screen Involuntary Stop Test To verify proper functioning of the Very High Priority audible alarm perform the following 1 d Press the VENTILATION ON OFF key to start ventilation Set the I O switch to the O off position to power down the ventilator during ventilation Ensure that the following events occur e An audible alarm sounds continuously e The ventilator turns off There should be no alarm indicators illuminated and no alarm messages displayed Press the ALARM CONTROL key once to silence the audible alarm Puritan Bennett 560 Ventilator Clinician s Manual G
135. can be deactivated Refer to chapter 7 3 1 Preferences Menu Press and release keys in the normal prescribed manner Do not press keys for 45 seconds or more If unsuccessful in releasing the stuck key s restart ventilator to see if alarm clears If not replace the device and call your customer service representative if the situation persists Immediately connect the ventilator to an AC power outlet or connect it to an external DC power source Reminder the internal battery can be charged only when the ventilator is connected to an AC power supply Note Always consult the clinician before changing PEEP FIO3 pressure volume or Rate settings Check the level of oxygen corresponds to the patient s prescription or Decrease the FIO alarm threshold Puritan Bennett 560 Ventilator Clinician s Manual Alarms and Troubleshooting Table 5 2 Alarms and Corrective Actions Continued oa Message or Possible Reason s For The Alarm Event Corrective Action s ymptom the patient circuit Check and properly connect the patient circuit connections Leak in the patient circuit May be caused by increased resistance across exhalation filter such as excessive moisture Restore or connect the exhalation block refer to section 6 7 Exhalation Block on page 6 12 If the exhalation block has been removed or replaced calibrate the exhalation flow sensor see section 10 1 Calibrating the Exhalati
136. cancel the alarms F 2 Apnea Test Apnea breaths only apply in PSV CPAP and SIMV modes Puritan Bennett 560 Ventilator Clinician s Manual F 1 Alarms Tests F 3 F 4 F 2 1 Connect the patient end of the patient circuit to a test lung 2 Verify that the pressure tube of the patient circuit is properly connected to the appropriate fitting on both the ventilator and the proximal pressure port refer to section 6 4 Patient Circuit on page 6 6 3 Press the VENTILATION ON OFF key to start ventilation The ventilator will deliver a mandatory breath Before the second mandatory breath is delivered verify that the following events occur e the Medium priority indicator yellow colour illuminates e the APNEA alarm is displayed e an audible alarm sounds 4 Press the ALARM CONTROL key twice to reset the alarm 5 Press the VENTILATION ON OFF key for three 3 seconds before releasing it Ventilation stops Power Failure Test Note If the ventilator is operating on either the external power supply or the internal battery you must plug it in to an AC power source before beginning this test 1 Disconnect the ventilator from its AC power supply Ensure that the following events occur e the Medium priority indicator yellow colour illuminates e the AC POWER DISCONNECTION alarm activates e anaudible alarm sounds e the DC POWER indicator illuminates if the DC power source is connected othe
137. ce the ventilator and call your inside the device customer service representative 5 26 Puritan Bennett 560 Ventilator Clinician s Manual Troubleshooting Puritan Bennett 560 Ventilator Clinician s Manual 5 27 Alarms and Troubleshooting 5 28 Puritan Bennett 560 Ventilator Clinician s Manual Installing the Ventilator 6 Installation and Assembly nN WARNING Before operating the ventilator read understand and strictly follow the information contained in Chap ter 1 Safety Information A patient treated by mechanical ventilation is highly vulnerable to the risks of infection Dirty or contaminated equipment is a potential source of infection Clean the ventilator and its accessories regularly and systematically before and after each use and following any maintenance procedure to reduce the risks of infection The use of a bacterial filter at the ventilator s outlet or both ports if a double limb circuit is used is highly recommended Refer to chapter 9 Cleaning 6 1 Installing the Ventilator To install your Puritan Bennett 560 Ventilator e Choose an area where air can circulate freely avoid proximity to loose fabrics such as curtains e Avoid direct exposure to sunlight e Set the ventilator on a flat and stable surface so that its feet are all in contact with the surface The ventilator may operate in any position provided that the air inlets are not obstructed and the device cannot
138. charging of the internal battery impossible Inspired tidal volume during exhalation lt 20 of Inspired tidal volume and Inspired tidal volume gt 20ML Exhalation valve obstructed Internal ventilation fault related to exhalation valve detection sensor pressure sensor FiO measurement is less than 18 Recalibrate or change FiO sensor 1 Loss of signal from the proximal pressure sensor Consequence switch to internal pressure sensor for the pressure measurement Alarm activation occurs In the event of signal loss 1 After one ventilation cycle Or In the event of signal loss 2 and after the 17 breath cycle After 17 seconds for P A C and V A C modes or after the maximum time between 17 seconds and Apnea Time 4 seconds for CPAP PSV P SIMV and V SIMV modes i Puritan Bennett 560 Ventilator Clinician s Manual Alarms and Troubleshooting 5 9 Table 5 1 Overview of Alarms Continued Alarm Message CHECK REMOTE ALARM CHECK SETTINGS CONNECT VALVE OR CHANGE PRESS CONTROLLED CYCLES COOLING FAN RESTART SRVC DC POWER DISCONNECTION DEVICE FAULT3 RESTART SRVC DEVICE FAULT5 RESTART SRVC DEVICE FAULT7 RESTART SRVC DEVICE FAULT9 RESTART SRVC Cause Ventilator Response No activation of Nurse Call or remote alarm system when an alarm is in progress Alarm activation occurs e Systematically after software versions have changed
139. cluded from these regulations although for air transport some requirements apply For air transport the Puritan Bennett 560 Ventilator is permitted as checked in or carry on baggage Two spare batteries per person may be taken on board as carry on luggage only with the prior approval of the airline This classification and regulatory requirements may vary depending upon the country and mode of transport Therefore it is recommended that users verify with the carrier airline as to which measures to take before the voyage Ensure that the ventilator s internal battery is fully charged before connecting the ventilator to an external DC power source Powering the ventilator using an external 12 30 VDC power source via the DC power cable does not enable charging of its internal battery The maximum recommended shelf life of the internal battery is two 2 years Do not use a battery that has been stored for two years prior to its first use Periodic recharging is important to help maximize useful life of the battery Do not store the internal battery for extended periods without recharging as this may reduce the maximum life 8 1 Battery Capacity The reserve capacity offered by the internal battery depends on the level of ventilation parameters the environmental conditions primarily in terms of temperature and the physiological characteristics of the patient With a fully charged battery at a normal room temperature of 25 C 5 C
140. creases b To decrease the contrast press DOWN This change can be observe as the cursor moves to the left The display contrast progressively decreases 3 Confirm the new Contrast setting by pressing ENTER WY before seven 7 seconds elapse When ventilation is stopped the contrast can also be changed directly from the currently displayed menu by pressing ALARM CONTROL continuously while repeatedly pressing UP X 4 or DOWN Y The default setting for Contrast is the medium setting the middle of the bar graph 7 3 4 Alarm Volume A N WARNING The sound level of the alarms should be adjusted according to the installation environment and the size of the area monitored by the patient s caregiver Ensure that the alarm sound apertures at the front of the device are never obstructed To set the Alarm Volume 1 Select the Alarm Volume parameter on the display 2 Set the Alarm Volume level a To increase the sound level of alarms press UP g a This change can be observed as the cursor moves to the right El The buzzer activates and increases in sound level as the setting increases b To decrease the sound level of alarms press DOWN v_ This change can be observed as the cursor moves to the left The buzzer activates and decreases in sound level as the setting decreases Puritan Bennett 560 Ventilator Clinician s Manual 7 11 Operating Procedures 3 Confirm the ne
141. ctivated e After 60 seconds if the cause s of the alarm s persist s e Whenever a new alarm is activated Note If a key is stuck or held down for 45 seconds a keypad alarm will occur Puritan Bennett 560 Ventilator Clinician s Manual Alarms and Troubleshooting 5 9 5 6 5 5 Pausing Resetting Alarms A N WARNING Alarm volume should be adjusted with respect to the ventilator s operating environment and so that the patient s caretakers can hear the alarms The audible alarm vents located at the front of the device should never be obstructed The alarm can be paused with the Alarm Pause function by pressing the ALARM CONTROL key twice once the alarm has been declared When an alarm condition is triggered or there is evidence of a patient ventilator fault or problem examine the patient first before examining the ventilator Some alarms are not automatically cancelled when the condition causing the alarm clears e g HIGH PRESSURE Some alarms can be paused manually even if the cause s of their activation remain s To manually pause an alarm proceed as follows Press the ALARM CONTROL key twice e The alarm is paused until the alarm condition is corrected and the condition reoccurs the audible portion light indicator and message are all halted for the alarms which can be paused manually e The Alarm Paused yan symbol is displayed at the top right of the Ventilation Alarms and Waveforms screens Refer to Figu
142. d 5 20 Puritan Bennett 560 Ventilator Clinician s Manual Alarms and Troubleshooting Table 5 2 Alarms and Corrective Actions Continued Alarm Message or Symptom HIGH LEAKAGE Inappropriate patient circuit HIGH VTE Exhalation flow sensor not calibrated properly Defective exhalation flow sensor Adjustment of the Max VTI level too low for PSV CPAP P A C P SIMV and V SIMV modes HIGH VTI for the volume required for PSV CPAP P A C P SIMV and V SIMV modes Adjustment of the Max VTE level too low Adjustment of the pressure level too high Possible Reason s For The Alarm Event Corrective Action s The LEAK estimated by the ventilator Readjust mask to reduce leakage or exceeds the Max LEAK alarm threshold Increase the alarm settings Note Always consult the clinician before changing PEEP FIO gt pressure volume or Rate settings Modify the Max VTE level Replace the patient circuit Ensure there is not excessive airflow near the exhalation block such as a fan Calibrate the exhalation flow sensor refer to section 10 1 Calibrating the Exhalation Flow Sensor on page 10 1 Replace the exhalation block and calibrate the exhalation flow sensor see section 10 1 Calibrating the Exhalation Flow Sensor on page 10 1 Call your customer service representative Note Always consult the clinician before changing PEEP FIO3 pressure volume or Rate settings
143. d Markings Rear View Puritan Bennett 560 Ventilator Clinician s Manual Labels Identification and Instruction Information Figure 1 4 Location of Labels Bottom View Puritan Bennett 560 Ventilator Clinician s Manual 1 17 Safety Information This page intentionally blank 1 18 Puritan Bennett 560 Ventilator Clinician s Manual 2 Ventilator Overview 2 1 Indications for Use The Puritan Bennett 560 Ventilator is indicated for the continuous or intermittent mechanical ventilatory support of patients weighing at least 11 Ib 5 kg who require mechanical ventilation The ventilator is a restricted medical device intended for use by qualified trained personnel under the direction of a doctor It is essential to read understand and follow these instructions before using the Puritan Bennett 560 Ventilator Target Patients Specifically the ventilator is applicable for adult and pediatric patients who require the following general types of invasive or non invasive ventilatory support as prescribed by an attending doctor e Positive Pressure ventilation e Assist Control SIMV or CPAP modes of ventilation e Breath types including Volume Control Pressure Control and Pressure Support Target Environments The ventilator is suitable for use in institutional home and portable settings It is not intended for use as an emergency transport ventilator The Puritan Bennett 560 Ventilator is suitable
144. d and operated in the environmental conditions recommended in Appendix B Specifications e Do not leave power cables lying on the ground where they may pose a hazard e Do not operate the ventilator in direct sunlight near heat sources outdoors or near installations where liquid may pose a risk without first providing adequate protection for the device e Avoid using the ventilator if possible in dusty environments Dusty environments may require more vigilant monitoring cleaning and or replacement of air intake and other filters e Ensure that the ventilator s immediate surroundings allow for the proper operational connection of the device without folding pinching or damaging any of the required cables or tubes and that the connection of the to the patient provides for a secure comfortable fit e Place the ventilator in a safe place when ventilating and according to the recommendations in this manual e Donot place the ventilator in a position where a child can reach it or in any position that might cause it to fall on the patient or someone else e To ensure correct and lasting operation of the ventilator ensure that its air circulation holes main inlet or cooling are never obstructed Place the device in an area where air can freely circulate around the ventilator and avoid installing it near floating fabrics such as curtains e Ifthe ventilator has been transported or stored at a temperature that differs more than
145. device disconnection or transfer error the message TRANSFER ERROR USB DISCONNECTION or TRANSFER ERROR TECHNICAL PROBLEM is displayed In this case restart the transfer process If the problem persists contact your technical service Puritan Bennett 560 Ventilator Clinician s Manual Locking the Control Panel 7 7 5 Erase Data from the USB Memory Device To erase data from the USB memory device 1 Use the UP 24 or DOWN _ arrow keys to place the cursor at the Erase key position TD CY 2 Press ENTER GA e The cursor changes to the plus minus symbol The parameter selected to be modified flashes Press UP 4 or DOWN A y to change the selected parameter s value T y Press ENTER CY to confirm the new parameter setting e The new parameter setting is displayed continuously e The cursor is placed at the STOP position PB560C75 PB560C76 USB MEMORY DEVICE USB MEMORY DEVICE SiN 40966K0001 SiN 40966K0001 o Transfer Continuously OFF Transfer Continuously OFF o Transfer Trends OFF Transfer Trends OFF Erase Key YES Erase Key YES ERASE IN PROGRESS Remaining Time OhHOmin m Stop Figure 7 27 Erasing Data from the USB Memory Device A WARNING Deletion erases ALL files present on the USB memory device Note The message ERASE IN PROGRESS REMAINING TIME is displayed during the deletion time The deletion time of a full USB memory device
146. display ventilation stopped figure 8 3 reserve capacity displayed 8 2 symbol 8 2 Beep 8 4 10 3 Blocking an alarm threshold 7 21 Breath types D 2 Breathing Circuit 6 6 BUZZER FAULT1 alarm message 5 7 5 16 BUZZER FAULT2 alarm message 5 7 5 16 BUZZER FAULT3 alarm message 5 7 5 16 BUZZER FAULT4 alarm message 5 8 5 16 BUZZER LOW BATTERY alarm message 5 7 5 16 C CALIBRATE FIO2 alarm message 5 8 5 16 Calibrating exhalation flow sensor 10 1 Calibrating the FIO2 sensor 10 3 calibrating the FIO2 sensor 10 3 Calibration Fail alarm 10 3 CALIBRATION FAIL alarm message 5 8 5 16 10 3 Capacity of the battery 8 7 Carbon dioxide risk of inhalation and suffocation 7 7 7 28 Carrying bag ventilator figure G 7 Changing ventilation modes 7 16 CHECK BATTERY CHARGE alarm message 5 8 5 16 CHECK EXH VALVE alarm message 5 8 5 17 CHECK EXH VALVE PRESSURE alarm message 5 8 5 17 CHECK FIO2 SENSOR alarm message 5 8 5 17 CHECK PROXIMAL LINE1 alarm message 5 8 5 17 CHECK REMOTE ALARM alarm message 5 9 5 17 CHECK SETTINGS alarm message 5 9 5 17 Classification of device 2 3 Cleaning accessories 9 2 exhalation block 9 2 solutions and products approved 9 7 ventilator 9 7 Puritan Bennett 560 Ventilator Clinician s Manual Clinician responsibilities A 7 CONNECT VALVE OR CHANGE PRESS alarm message 5 9 DAT Connecting to AC power 6 2 DC power
147. e APNEA alarm will not activate If an APNEA alarm is required set the APNEA setting to YES in the Preferences Menu The Apnea Alarm should be set to YES for ventilator dependant patients Setting Alarm limits to extreme values can cause the ventilator alarms to malfunction Ensure the Insp Time setting is compatible with the physiological requirements of the patient Adjustable alarms should not be systematically cancelled instead they should be adjusted according to the needs and condition of the patient A continuous alarm condition will be activated if the ventilator power switch is turned off while ventilation is in progress When the power switch is turned back on again the ventilation will resume without having to press the VENTILATION ON OFF button Puritan Bennett 560 Ventilator Clinician s Manual Warnings In the SIMV mode the use of a double limb circuit is recommended The Min VTE setting should remain active in the event that pressure losses are present on the patient circuit downstream from the proximal pressure link In such cases the PATIENT DISCONNECTION alarm would not be systematically activated in case of a disconnection of the circuit The inspiration trigger threshold should be carefully modified in order to avoid the risk of false triggering or autotriggering of the ventilator For example Level 1P the most sensitive mode is recommended for pediatric use However for an adult this setting may res
148. e H 1 Table H 2 Electromagnetic IMMUNITY ssncacces sooo cedexrcsssscaceaad dower norii iain atai B 11 Electromagnetic Immunity Conducted and Radiated RF 0eeeeees B 12 Recommended Separation Distances 0c cece cece cece cent eee e eee e eee eeeees B 13 Compliant Cables and Accessories 0 0 0 cece cece eee eee eee e cece cece eeeeeeees B 14 Operational Verification Checklist 0 0 cece cece cece eee e eee eeeeeeees E 1 List of Consumables and Accessories 1 ccc ccc ccc ce cee ee enn en eeeeeeeeees H 1 Litor C U errer iirde ninar AREALE EAA H 2 Puritan Bennett 560 Ventilator Clinician s Manual Preface Purpose of This Manual This manual contains important information regarding the safe operation of your Puritan Bennett 560 Ventilator Your ventilator is an electrical device that can provide years of useful service with the proper care as described in this manual Ensure that you read and understand the instructions contained in this manual before operating the ventilator WARNING Before operating the ventilator read understand and strictly follow the information contained in Chap ter 1 Safety Information Qualification of Personnel Installation and maintenance of the device must be made by authorised and trained personnel In particular training for the handling of products sensitive to electrostatic discharges must include the use of Electrostatic Discharge ESD pro
149. e Nurse call function provides for remote alerts of ventilator alarm conditions for example when the ventilator is used in an isolation room and features the following e The ventilator signals an alarm using a normally open NO or a normally closed NC signal e A remote alarm is activated when an alarm condition occurs unless either of the following is true e The audio paused function is active e The ventilator power switch is OFF e The remote alarm port is an 8 pin female connector allowable current is 100mA at 24VDC max Puritan Bennett 560 Ventilator Clinician s Manual 6 19 Installation and Assembly This page intentionally blank 6 20 Puritan Bennett 560 Ventilator Clinician s Manual Turning on the Ventilator 7 Operating Procedures 7 1 Turning on the Ventilator A N WARNING Before operating the ventilator read understand and strictly follow the information contained in Chap ter 1 Safety Information If the ventilator has been transported or stored at a temperature that differs more than 20 C 36 F from the temperature in which it will be operating the ventilator should be allowed to stabilise in its oper ating environment for at least two 2 hours prior to use To reduce the risk of a fire hazard keep matches lighted cigarettes and all other sources of ignition such as flammable anesthetics and or heaters away from the ventilator and oxygen hoses While the ventilator is in
150. e Vt 250ml e PEEP OFF e Flow Pattern D e R Rate 30 bpm e L E 1 4 or I T 20 e Insp Sens 3 e High Pressure Alarm 12 mbar e Low Pressure Limit must be 4 or lower 2 Connect the patient end of the patient circuit to a Maquet test lung 3 Verify that the pressure tube of the patient circuit is properly connected to the appropriate fitting on both the ventilator and the proximal pressure port refer to section 6 4 Patient Circuit on page 6 6 4 Press the VENTILATION ON OFF key to start ventilation 5 Allow the ventilator to deliver three 3 consecutive breaths At the beginning of the fourth breath ensure that e the High priority indicator red colour illuminates e the HIGH PRESSURE ALARM activates Puritan Bennett 560 Ventilator Clinician s Manual F 3 Alarms Tests F 6 F 7 F 4 tS o e an audible alarm sounds Press the ALARM CONTROL key once to silence the alarm Set the High Pressure parameter value to 40 mbar e The alarm is cancelled Press the VENTILATION ON OFF key for three 3 seconds e Ventilation stops Testing the Battery The ventilator is capable of testing the power of the battery refer to chapter 8 Internal Battery You can determine which power source the ventilator is using by checking the power indicator located on the top panel The indicator light will be lit to indicate which power source is currently available 1 Disconnect the AC power supply
151. e as the default and automatically switches to the next calibration point Ifa CALIBRATION FAIL alarm occurs do the following 1 Ensure the exhalation block is properly seated 2 Ensure an approved circuit is in use refer to circuit documentation 3 Check the integrity of the circuit and all connections 4 Ensure the correct circuit type is selected in the ventilator preferences 5 Repeat the calibration procedure keeping a tight seal over the end of the circuit during calibration For more information on the CALIBRATION FAIL alarm refer to section 5 8 Troubleshooting 10 2 Calibrating the FiO sensor Each time the FiO sensor is removed and reinstalled and on a weekly basis the FiO sensor must be recalibrated before using the ventilator This process does not require the use of a measurement device To calibrate the FiO sensor refer to Figure 10 5 if required Figure 10 5 Calibrating the FiO sensor 1 Puritan Bennett 560 Ventilator Clinician s Manual 10 3 Routine Maintenance 1 Ensure the ventilator is on and in Standby mode 2 Ensure the Locking Key is disabled refer to section 7 9 Unlocking the Control Panel on page 7 26 Connect the FiO sensor to the ventilator Refer to chapter 6 8 3 Connecting the FIO2 sensor 4 Press the MENU key to access the alarm settings menu if this is not the menu currently displayed 5 Press the UP At or DOWN 6 vy
152. e of a setting that requires such a feature is when the ventilator is used in an isolation room The ventilator signals an alarm using a normally open NO or a normally closed NC signal A remote alarm is activated when an alarm condition occurs unless either of the following is true e Audio paused function is active e Ventilator power switch is turned off The remote alarm port is an 8 pin female connector Allowable current is 100 mA at 24 VDC maximum Rtot 15 bpm 1 5 A hr duration lt 6 hr 0 5 A hr duration lt 13 hr Average operating time at 25 C 5 C with a fully charged battery having less than 50 charge discharge cycles at the following displayed values 11 hr 10 9 hr 10 6 5 hr 10 4 5 hr 10 Nurse call pin out view from back of ventilator Alarm Wire color relay common black 5 4 remote supply not used 7 remote supply not used Puritan Bennett 560 Ventilator Clinician s Manual Specifications B 3 Indicators and Alarms Table B 5 Power Indicators e Blue in standby mode Green Green e Flashing if the battery e Not lit if ventilation is in charge is in progress progress Continuously lit if the ventilator is powered by the internal battery Table B 6 Alarm Indicators High Priority Medium Priority Red flashing LED Yellow flashing LED Table B 7 Audio Alarms Audio Paused Alarm Volume 65 to 85 dBA 10 at 1 meter
153. e patient has been ventilated 7 6 Puritan Bennett 560 Ventilator Clinician s Manual Note Setup Menu Parameters Resetting the patient hours will also reset the trends stored in the device memory in preparation for a new patient To reset the Patient Hours counter to zero 1 Press DOWN v to place the cursor at the Patient Hours line as shown in the following graphic Machine Hrs O Language O Date o Time o Cycling Mode o Relative pressure O Pressure Unit o E Sens Settings o Patient Hours Reset Hours o Maintenance SETUP 00000h ENGLISH 01 JAN 2099 02 12 04 RE YES mbar POSITIVE 00000h O0min PB560C80 OFF Figure 7 7 Resetting Patient Hours to Zero 1 2 Press ENTER WY e The cursor is placed on the Reset Hours line OFF 3 Press ENTER WY e OFF flashes 4 Press UP 4 or DOWN A to change the OFF message to YES as shown in the following graphic Machine Hrs o Language O Date o Time o Cycling Mode o Relative pressure o Pressure Unit o E Sens Settings o Patient Hours Reset Hours o Maintenance PB560C81 SETUP 00000h ENGLISH 01 JAN 2099 02 32 54 mH YES mbar POSITIVE 00000h OOmin YES Figure 7 8 Resetting Patient Hours to Zero 2 5 Press ENTER V e YES is displayed continuously e Along beep sounds e The patient counter display
154. e port item 8 Connect one end of the exhalation valve tubing item 6 to the exhalation valve port on the exhalation valve item 5 and the other end onto the ventilator exhalation valve port item 9 To protect the exhalation port as it will not be used in this configuration place the cap if provided with the breathing circuit over the exhalation port opening item 10 See also Figure 6 9 on page 6 9 NOTE Although shown here the humidifier item 3 water trap item 4 and tubes upstream of the single limb patient circuit are not included with the ventilator Contact your supplier for more information VEN_10101_6 Figure 6 7 Single Limb Patient Circuit With Exhalation Valve To connect a double limb circuit refer to Figure 6 8 1 Inspect the components of the patient circuit for any signs of damage such as cracks which might cause leakage Do not use damaged components to assemble the patient circuit ys 2 Install the bacteria filter item 1 on the TO PATIENT q outlet port Puritan Bennett 560 Ventilator Clinician s Manual 6 7 Installation and Assembly 3 Attach one end of the short circuit tubing item 4 to the filter item 1 4 Attach the other end of the circuit tubing to the inlet port of the humidifier item 2 5 Place a water trap item 3 between the outlet port of the humidifier and the patient wye item 5 on the double limb circuit 6 Place asecond water trap
155. e saved for this next mode whether or not it is used immediately afterwards When setting the parameters of the future and currently inactive mode the monitoring data for the mode in progress are displayed in the window to the right of the menu and also in the central Patient column of the table on the Alarm menu screen When changing the value of a parameter in this inactive mode the monitoring data displayed in the window on the right side of the screen are temporarily hidden by the display of the value currently being changed This is shown in the following figure as the PEEP setting is adjusted in the inactive V A Cmode PB560C59 INACTIVE 500 mL OFF ot 43 bpm 1 2 0 i OFF o Accept Mode YES 0 mbar 5 Figure 7 19 Changing Ventilation Modes During Ventilation 4 If an alarm is triggered during the setting of an inactive mode its message is displayed in the alarm message display When the menu of an inactive mode is displayed and no changes are made by the user on the keyboard within 14 seconds the display of the active ventilation mode in use reappears on the screen and the Accept Mode YES line disappears The menu of the active mode can also be recalled without waiting for this delay by directly restoring the name of the mode on the general information line Puritan Bennett 560 Ventilator Clinician s Manual 7 17 Operating Procedures 7 5 The ventilation parameters of the
156. e ventilator is connected to an AC supply and the battery is charging indicator is flashing Puritan Bennett 560 Ventilator Clinician s Manual 6 3 Installation and Assembly 6 3 6 4 a amp a x rr 5 Cia OKO Figure 6 4 Power Indicators WEN_ 10028 C To disconnect the AC power cable 1 Disconnect the AC power cable from the AC power outlet 2 Disconnect the AC power cable from the ventilator s AC connector at the rear of the device 3 Grasp the AC power cable at the level of the power cable holder and turn the cable counterclockwise while lifting it upwards and out of the holder Connecting to an External DC Power Source WARNING Ensure that the ventilator s internal battery is fully charged before connecting the ventilator to an external DC power source Powering the ventilator using an external 12 30 VDC power source via the DC power cable does not enable charging of its internal battery When using a car auxiliary adapter cigarette lighter ensure the car has been started prior to plugging in the ventilator s DC adapter Note An alternative means of ventilation should always be available particularly when the patient is in transit or away from wall power While using the ventilator on external battery power it is vital that a qualified caregiver capable of providing necessary corrective actions in the event of alarm conditions is present When AC power is not available use an
157. ecting Transfer Trends To transfer trend data from a ventilator to a USB memory device 1 Use the UP a t or DOWN A v arrow keys to place the cursor at the Transfer Trends position Press ENTER CD The cursor changes to the plus minus symbol The parameter selected to be modified flashes Press UP 4 or DOWN Cv to change the selected parameter s value Press ENTER G to confirm the new parameter setting The new parameter setting is displayed continuously The cursor is placed at the STOP position To manually stop trend transfer press ENTER GA If a parameter change is not confirmed by pressing ENTER G before seven 7 seconds elapse the ventilator resets the parameter to its previous value Note Table 7 3 Time taken to transfer trends data from the ventilator to a USB memory device Amount of trends data Transfer time from ventilator in months to USB memory device The message TRANSFER IN PROGRESS REMAINING TIME is displayed during the transfer time Other USB memory device functions are available during transfer of trends If the memory capacity on the USB memory device is insufficient the message TRANSFER NOT ALLOWED USB CAPACITY INSUFFICIENT is displayed and data transfer is not allowed Delete the data on the USB memory device before restarting data transfer Refer to deletion process Refer to chapter 7 7 5 Erase Data from the USB Memory Device In case of USB memory
158. ed for the parameter continuing to press on these keys speeds up the progression of values displayed 4 Press ENTER GA to confirm the selected value e The new parameter value is displayed continuously e The zoom disappears e The cursor returns to normal Note If a parameter change is not confirmed by pressing ENTER OD before seven 7 seconds elapse the ventilator restores the parameter s previous value Puritan Bennett 560 Ventilator Clinician s Manual Setting Alarm Parameters 7 5 1 Links between Ventilation Parameters The adjustment ranges of certain parameters are limited in order to remain compatible with the levels of other previously set parameters For additional information on the interdependence between ventilation parameters refer to chapter 3 Operating Parameters The message Setting limited by is displayed and identifies the parameter s that is are blocking the setting Figure 7 21 item 1 shows that P Support cannot be set above 35 when PEEP is set to 20 and relative pressure is set to YES this value is limited by PEEP because their sum cannot exceed 55 mbar PB560C61 o PSW ST INACTIVE IPAC ACTIVE 1 FP Support 35 mbar 30 PEEP 20 mbar ee F Suppor PEEP Rise Time 2 z sera Insp Sens 2 T Exh Sens AUTO 3 5 Backup F 13 bpm Apnea time AUTO M Setting limited by gt ViTarget OFF A PEEP Accept Mode YES o mbar Figure 7 21 Setting Links Between Ventilation Par
159. eded AN Warnings Regarding Electrical Power Supplies e Never connect your ventilator to an electrical outlet controlled by a wall switch because the power may be inadvertently turned off e The operator should connect the ventilator to an AC power source whenever available for safer operation e The maximum recommended shelf life of the internal battery is two 2 years Do not use a battery that has been stored for two years prior to its first use e Periodic recharging is important to help maximize useful life of the battery Do not store the internal battery for extended periods without recharging as this may reduce the maximum life Puritan Bennett 560 Ventilator Clinician s Manual 1 3 Safety Information 1 4 For the AC mains power cable to be properly secured the attachment located on the power cable must be fitted into the power cable holder incorporated in the battery access cover and located under the AC mains power socket Refer to section 6 2 Connecting to External AC Power The power supply to which the ventilator is connected both AC and DC must comply with all applicable standards and provide electrical power corresponding to the voltage characteristics inscribed on the rear of the ventilator to ensure correct operation Refer also to the electrical specifications found in Appendix B Specifications Ensure that the ventilator s internal battery is fully charged before connecting the ve
160. eden Tel 46 858 56 05 00 Fax 46 858 56 05 29 Asia Tyco Healthcare Pte Ltd Singapore Regional Service Centre 15 Pioneer Hub 06 04 Singapore 627753 Tel 65 6578 5187 8 9 Fax 65 6515 5260 Email Tech_support covidien com Preface 3 This page intentionally blank Preface 4 Puritan Bennett 560 Ventilator Clinician s Manual Definitions 1 Safety Information 1 1 Definitions This manual uses three indicators to highlight critical information Warning Caution and Note They are defined as follows A WARNING Indicates a condition that can endanger the patient or the ventilator operator Caution Indicates a condition that can damage the equipment Note Indicates points of particular emphasis that make operation of the ventilator more efficient or convenient It is essential to read understand and follow these instructions before using the Puritan Bennett 560 Ventilator In order to use the ventilator correctly and efficiently and to help prevent incidents please pay particular atten tion to sections 1 2 Warnings as well as all warnings and cautions contained throughout this manual 1 2 Warnings AN General Warnings Regarding Use e The ventilator must be used only under the responsibility and on the prescription of a doctor e The ventilator must be used according to its intended use Refer to section 2 1 Indications for Use e Be aware this manual describes how to respond to vent
161. ee 3 18 Ventilation Parameters in VSIMV Mode ccc ccc cc cece eee ee eeeeneaes 3 23 Alarm Parameters in the V SIMV Mode Menu 0cceeeeeeeeeeeeeeeeeeeees 3 24 Displayed Monitored Parameters cece cece cece eee eeeeeeeeeeeeees 4 4 Overview Or Alans 4445654500 wivens sedans ao roo UTEE SSE ENAERE TEENIE ERER AAE 5 7 Alarms and Corrective Actions ssssussesuesessnsresersersesoesersesersee 5 15 Additional Troubleshooting and Corrective ACtiOns 0c cece cece eees 5 25 LAMGQUWAOGS sascansecacnanpee 2 aioe Gk wane ue aenasesooteasceeesueneuesenaseseaeeeeeess 7 5 USB Memory Device Specifications ccc ccc ccc cence eee e ence eee ene eens 7 22 Internal Battery Reserve Capacity ccc cece ccc cece tence eee eee eee eeeeees 8 1 Approved Cleaning Solutions for Exterior Ventilator Surfaces 0000 ees 9 1 Consumables and Replacement Intervals ccc cece ce cece eee ee eeeees 10 6 Patlent Caregiver Checklist die c6dcc0 cure cect wee retinneheteegeteeteu ravidenarenons A 1 Physical Description Excluding ACCe SSOrie S 0 cece cece cece eens eee e eens B 1 AC Electrical SUD O22 ccccacamaeencscaeee ater eaer En EREDE EDSA B 1 internal Lithium lom Batte cserisrsriss erered sonr 0645 secleneessens EDET N ESETA B 1 Remote Alarm cates inp arpetad oan rirdi 6 We ods ANAREN EET EEEE ERRANTE EREE B 2 Power NGICALONS 4 6 54 4404 04656 56 5 09 00a eee a oe EOC ETEEN emer ea
162. efer to section 5 6 Re activating Alarms on page 5 5 To dismiss the Alarm Logs screen manually Press the ENTER WY key when the cursor is on the Back line The Alarm Logs screen is dismissed automatically e After 15 seconds if no keyboard action is detected e When a High Priority alarm is triggered Note Only qualified service personnel may access all alarms and events recorded by the ventilator Qualified personnel should refer to the Puritan Bennett 560 Service Manual for further information Silencing the Audible Portion of Alarms You may silence the audible portion of alarms for 60 seconds at a time This is referred to as the Audio Paused function To silence the audible portion of activated alarms Press the ALARM CONTROL key e The audible portion of all activated alarms is paused e The visual portions light indicator and message of activated alarms remain visible e The Audio Paused symbol EX is displayed at the top right of the screen while the audio pause function is active PB560C38 a PAC ABS o PIP 15 mbar OPEEP OF o Rise Time 72 13bpm 1 2 0 2 ovtTarget OFF BE VENTILATION 10 ACPOWER me DISCONNECTION Figure 5 5 Silencing the Audible Portion of Alarms TO START o Preferences If several alarms are activated at the same time pressing the ALARM CONTROL key affects all current alarms The audible portion of activated alarms is automatically rea
163. eform Menu Pressure Valve Modes PSV S PSV ST PCV PA C 0008 4 3 Waveform Menu Volume Mode CV V A C SIMV 0 0 0 cece cece eee ee eee eeeees 4 3 Monitored Parameter Inserts ccc ccc ccc ccc cece eee e eee eeeeeeeeeeeaeaes 4 3 Display Showing Unavailable Parameter Values cc cee cece eee e ee eees 4 4 Inspiratory Effort Detected Indicator lt si ccxdsesestederscaanierednvas paeed sawenexe 4 4 Bargrapn Displayecsirresir iieri aR Garne korene RENNENE ER 4 6 Waveform Screen i pcasuo ches ewre evades ine ieuneaewn ki deseeeecienaserageereret es 4 6 Ventilation REDONE ws dc os serura Seabee tewawouscbes octet de s645 0tencaun ee cs boxe ce lt 4 7 Aarm OSD VG ciecccaua dated ee went ee eae eeue eeu erhe cunese orca eoeniaeaenecday 5 2 Accessing Alarm Logs MeNnu cc cece cece eee e eee e eee eee ee eeeeeeee 5 3 Displaying the Alarm LOGS Screen 2 2 lt 1i 2casccegecaieeeesdnawa deed esenedeneds sds 5 3 Alarm Logs Display when No Alarm Activated cece cee cece cece eee e cece 5 3 Silencing the Audible Portion of Alarms ccc cece cece eee ence eee eeeeees 5 4 Manually Pausing AlanniSis o gs0edectsiteussdestevatetseessteksieeueeeeinedeeiads 5 5 Reactivating Alans ss srss snien ror EENE EROE wks ees dda AREAS SE ORNS Cow ees 5 6 Aan OOS rarer anna E ends env ewes eae a eae ER 5 6 Puritan Bennett 560 Ventilator Clinician s Manual Vv Figure 6 1 Figure 6 2 Figure 6 3 Fig
164. egulator and special oxygen connector Puritan Bennett 560 Ventilator Clinician s Manual Warnings e To avoid injury to the patient and or possible damage to the ventilator before connecting the ventilator to the oxygen supply ensure a flow meter flow regulator is connected to the ventilator to regulate the oxygen supply to the required specification e The Puritan Bennett 560 Ventilator can be used with an optional oxygen analyser with minimum and maximum concentration alarms Always measure the delivered oxygen with a calibrated oxygen analyser FiO kit that features a minimum and maximum concentration alarm in order to ensure that the prescribed oxygen concentration is delivered to the patient e The Puritan Bennett 560 Ventilator is designed to deliver a percentage of oxygen equal or lower than 50 Do not exceed this value as this may cause the ventilator to malfunction and put the patient at risk e Ensure that the oxygen supply pressure to the machine never exceeds 7 psi 50 kPa ora flow of 15 Ipm Refer to Table B 8 on page B 3 for volume and sensitivity tolerances e Inthe event of an oxygen leak shut down the supply of oxygen at its source In addition remove and or keep any incandescent source away from the device which may be enriched with oxygen Circulate fresh air into the room to bring the oxygen level down to normal e The hose connecting the ventilator to the oxygen source must be designed exclusively for
165. ent actively triggers a breath mbar PB560C01 TO START 5 VENTILATION 6 PB560C02 Meth 928m a Leak O 0Lom E iio 0 0L M Fate 25 bpm 5 10 lE 1 2 0 M Fio 6 3 Preferences menu access line Highlight this line and press the ENTER key to display the Preferences menu Refer to manual section 7 3 Preferences Menu Parameters on page 7 8 for more information 6 Alarm conditions window e For Active alarms scrolls through active alarm messages in flashing reverse video e For Inactive alarms displays the last alarm along with its trigger date and end of event time Refer to chapter 5 Alarms and Troubleshooting for details Figure 2 4 Ventilation Menu Display 2 7 2 9 Alarm Menu 1 o CVW V AC l Min Current Max j BPIP mbar Alarm menu with ventilation on standby 2 Alarm menu when not in standby 1 Title line 2 Alarm settings Displays ventilation mode and the Displays the specific alarm parameter following symbols values for the currently selected e Battery 4 if the ventilator is ventilation mode which are powered by the internal battery e Min and Max alarm threshold a e Audio paused 3 if an alarm is settings and currently inhibited Current monitored patient e Alarm paused 4X if an alarm has readings or hyphen when been cancelled manually and the ventilation is in standby cause of the alarm remains e Apnea Alarm deactivation R e Exhalation
166. entilation may be interrupted at any time during this phase Note The EMPTY BATTERY alarm symbol may disappear shortly before the ventilator completely stops but it always triggers a final continuous alarm Puritan Bennett 560 Ventilator Clinician s Manual 8 3 Internal Battery 8 3 8 4 Testing the Battery Your ventilator continuously and automatically checks the state of the internal battery even when the battery is not used as the main source of energy The BATTERY FAULT1 alarm is activated whenever a problem is detected in the battery or the charger However on a monthly basis you should disconnect the ventilator from the external power supply to check the integrity of the connections linking the internal battery to other ventilator components Recharging the Battery In the event that the battery charge level is considered insufficient as per the reserve capacity display recharge of the internal battery is necessary In general it is recommended that the ventilator be allowed to charge when the battery drops below 80 and that the ventilator be recharged systematically after storage and before using it again Note To avoid cycling and extend battery life while connected to an AC power source the battery will not begin charging until it has dropped below an 85 90 charge To charge the internal battery do the following Connect the ventilator to the AC power source e The AC POWER indicat
167. er to chapter 3 Operating Parameters In volume ventilation mode you can select between Square SQ Descending D or Sinusoidal S flow patterns Selected line filled square When making menu choices this graphic indicates the line on which the cursor is currently positioned See Figure 7 11 Selecting the Preferences Menu on page 7 9 Non selected line empty square When making menu choices this graphic indicates a line on which the cursor is currently not positioned Locked parameter line When making menu choices this graphic indicates a line that cannot be selected the Locking Key is enabled Active parameter line When making menu choices this graphic indicates that the current parameter is selected and can be changed See chapter 7 Operating Procedures Inspiratory Effort Detected This symbol appears in the front panel display s Status window when the patient triggers a breath Parameter adjustment bar This graphic shows the current setting for parameters such as display contrast and alarm volume in the Preferences menu Refer to section 7 3 Preferences Menu Parameters y WEEE Waste Electrical and Electronic Equipment This symbol means that this product must not be disposed of with household waste Observe local ordinances for proper disposal Refer to Table 1 2 item 5 k PAN Year of Manufacture Manufacturer Audio Paused This symbol means the sounding of audible
168. erating Parameters 3 4 E Sens EXHALATION SENSITIVITY E sens is available in the PSIMV VSIMV and PSV modes E Sens allows you to determine sensitivity of switching to exhalation and thus indirectly determines the inspiratory time of a breath The end of inspiration will occur when Inspiratory Flow has decreased to the preset E Sens setting The exhalation trigger is only taken into account after the Rise Time which constitutes a default minimum inspiratory time has elapsed If the flow drop is insufficient exhalation is automatically triggered independently of the E Sens which is defined as a percentage of peak inspiratory flow Exhalation may be triggered if the maximum inspiratory time of three 3 seconds has elapsed which corresponds to an I E Ratio of 1 1 0 to ensure that the patient has enough time to exhale 120 Insp 80 AO V LPM 6 Sec 40 80 Exh 120 Figure 3 3 Exhalation Trigger Sensitivity Note Refer to chapter 7 2 2 Changing the Setup Menu Parameters for positive and negative E Sens settings Backup R Backup R allows you to determine the frequency of ventilation breaths to be applied in the event of prolonged apnea as long as no inspiratory trigger is detected The inspiratory time of the backup breaths applied in the event of apnea still depends on the detection of Exhalation trigger E Sens and the safety maximum inspiratory time see above comment on E Sens The rise time
169. ers can hear the alarms The audible alarm vents located at the front of the device should never be obstructed The alarm can be paused with the Alarm Pause function by pressing the ALARM CONTROL key twice once the alarm has been declared Ensure that the I Sens setting is not set to OFF when ventilating patients capable of triggering spontaneous breaths Monitor the patient s state of health in order to ensure that the ventilator s settings are always suited to the patient s current physiological requirements In adult or pediatric use ensure that the adjusted tidal volume is compatible with the needs of the patient When changing the mode during ventilation significant transitions of pressure flow or cycling rate might occur depending on the difference between the modes Before setting the new mode first ensure that the settings between the different modes are compatible This reduces the risk of discomfort and harm to the patient Do not conduct the ventilator alarm test while the patient is connected to the ventilator Switch the patient to an alternate means of ventilation before testing The setting of the Low PIP alarm must be adjusted for the patient but must also be set high enough to allow the PATIENT DISCONNECTION alarm to trigger properly Perform the Low Pressure Test refer to section F 1 Low Pressure Test to ensure the Low PIP alarm is properly set If APNEA TIME is set to a value higher than 60 Control R then th
170. es it may take a significant period of time to cool the internal temperature of the ventilator to the proper operating range To avoid injury to the patient ensure that the air inspired by the patient does not exceed 41 C 106 F If in doubt replace the ventilator Defective internal temperature probe or Replace the ventilator and call your any other technical anomaly customer service representative CAUTION Ensure that ventilator is being used according to the operating instructions found in Appendix B Specifications If the ambient temperature is too low place the device in a warmer environment If the ambient temperature is too high place the ventilator in a cooler environment Battery temperature out of the For example ensure the ventilator is not in direct sunlight or next to an air conditioning vent The temperature fault alarm does not interfere with the HIGH LOW BATTERY TEMP tolerance ranges Defective internal temperature probe or operation of the ventilator any other technical anomaly inside the battery AN WARNING In case of operation in a high ambient temperature handle the ventilator with care some portions of the device may have high surface temperatures IF PERSISTS RESTART SRVC Restart ventilator to see if alarm clears if the alarm message persists please contact technical services CAUTION Do not attempt to charge a defective battery such a battery cannot be charge
171. esting conducted on 3 inch diameter test piece Table B 18 Oxygen Inlet Specifications Maximum pressure Maximum flow 50 kPa 7 25 psi 15 lpm Table B 19 Performance Specifications Working Sound pressure Maximum Internal Inspiratory pressure level pressure limit compliance triggering ventilator response time Ttr 5 mbar 55 mbar 30 dBA per NF 60 mbar 0001 mbar 100 ms EN ISO 17510 1 test conditions Manufacturer s Declaration The following tables Table B 20 through Table B 23 contain the manufacturer s declarations for the ventilator s electromagnetic emissions electromagnetic immunity and recommended separation distances between the ventilator and portable and mobile RF communications equipment as well as a list of compliant cables Puritan Bennett 560 Ventilator Clinician s Manual Specifications AN WARNING Portable and mobile RF communications equipment can affect the performance of the Puritan Bennett 560 Ventilator Install and use this device according to the information contained in this manual The ventilator should not be used adjacent to or stacked with other equipment except as specified in this manual If adjacent or stacked use is necessary the ventilator should be observed to verify normal operation in the configurations in which it will be used Table B 20 Electromagnetic Emissions The Puritan Bennett 560 Ventilator is intended for use in the electromagnetic environment
172. evel is not reached during a fixed time the alarm is triggered WARNING The setting of the LOW PIP alarm must be adjusted for the patient but must also be set high enough to allow the PATIENT DISCONNECTION alarm to trigger properly Perform the Low Pressure Test refer to section F 1 Low Pressure Test on page F 1 to ensure the LOW PIP alarm is properly set The Max PIP or Max Pressure setting determines the level of pressure which is not to be exceeded during the inspiratory phase Once this level is reached inspiration is terminated ventilation switches to exhalation and a High PIP alarm is triggered Refer to chapter 5 Alarms and Troubleshooting The difference between the Min PIP and Max PIP settings is limited to a minimum of 8 mbar This setting is also limited by the setting of PEEP thus the Min PIP setting must exceed the PEEP setting by at least 2 mbar In addition the Max PIP setting must exceed the PEEP setting by at least 10 mbar A change in the PEEP level may lead to automatic changes in the Min PIP and or Max PIP thresholds in order to maintain these setting differences Puritan Bennett 560 Ventilator Clinician s Manual V A C Mode Parameters and Setting Ranges VTE Min and or Max Alarm Settings EXPIRED TIDAL VOLUME Minimum and or maximum expired tidal volume settings are adjustable but can only be used with a double limb circuit configuration These thresholds can be set to trig
173. f false triggering or autotriggering of the ventilator For example Level 1P the most sensitive mode is recommended for pediatric use However for an adult this setting may result in autotriggering Apnea Time Apnea time allows the user to monitor and detect interruptions to the patient s spontaneous breathing pattern The ventilator declares apnea when no breath has been delivered by the time that the operator selected apnea interval elapses The APNEA TIME adjustment range shall be 1 to 60 seconds The ventilator shall enable the operator to set an auto setting which shall automatically calculate the APNEA TIME according to the following APNEA TIME 60 BACKUP R for PSV ST mode or 12 s for V SIMV and P SIMV modes The Apnea Time AUTO setting in seconds is calculated using the formula Auto Maximum value between 3 seconds and 60 Backup R or Auto 30 if Backup R OFF 3 20 Puritan Bennett 560 Ventilator Clinician s Manual P SIMV Mode Parameters and Setting Ranges Note e During apnea ventilation the ventilator delivers machine controlled breaths according to a backup rate Backup R as long as no inspiratory trigger has been detected e The Backup R value applied depends on the Rate setting Hence Backup R is at least equal to 8 bpm and takes the Rate value if Rate is greater than 8 bpm Time Min and Max Settings The minimum Min I Time and maximum Max Time duration of the inspiratory phase
174. f ventilation After assembling cleaning or reassembling the patient circuit and on a daily basis inspect the hoses and other components to ensure that there are no cracks or leaks and that all connections are secure Use all cleaning solutions and products with caution Read and follow the instructions associated with the cleaning solutions you use to clean your ventilator Use only those solutions listed in Table 9 1 Never use a liquid cleaner inside the patient circuit or on any component of a gas pathway Clean the patient circuit only as specified by the manufacturer s instructions Do not attempt to open repair or otherwise service the ventilator yourself Doing so might endanger the patient damage the ventilator and or void your warranty Only personnel authorised and qualified by Covidien should repair open or service the ventilator If the ventilator is damaged or its external housing is not correctly closed or it behaves in a way that is not described in this manual excessive noise heat emission unusual odor alarms not triggered during the start up procedure the oxygen and power supplies should be disconnected and use of the device stopped immediately The exhalation block is intended for single use by a single patient FA It may periodically be cleaned but it cannot be disinfected or sterilised To maintain good measurement quality when used continuously clean the exhalation block periodically refer to section 9 3
175. fall and possibly cause damage and or personal injury AN WARNING The operator should connect the ventilator to an AC power source whenever available for safer operation To ensure correct and lasting operation of the ventilator ensure that its air circulation holes main inlet or cooling are never obstructed Place the device in an area where air can freely circulate around the ventilator and avoid installing it near floating fabrics such as curtains Do not place the ventilator in a position where a child can reach it or in any position that might cause it to fall on the patient or someone else Ensure that the ventilator s immediate surroundings allow for the proper operational connection of the device without folding pinching or damaging any of the required cables or tubes and that the connection of the patient circuit to the patient provides for a secure comfortable fit Do not operate the ventilator in direct sunlight near heat sources outdoors or near installations where liquid may pose a risk without first providing adequate protection for the device If the ambient temperature where the device is operated is greater than 35 C 95 F the flow supplied at the device outlet may exceed 41 C 106 F This may lead to undesirable side effects for the patient To avoid injury to the patient move the patient and the ventilator to a cooler location For more information contact Covidien To reduce the risk of a fire haza
176. ficio San Jose Costa Rica Tel 506 256 1170 Fax 506 256 1185 Fax 506 290 8173 Covidien Deutschland GmbH Technisches Service Center Raffineriestr 18 93333 Neustadt Donau Germany Tel 49 944 595 93 80 Fax 49 944 595 93 65 Covidien France SA Parc d affaires Technopolis Bat Sigma 3 Avenue du Canada LP 851 Les Ulis 91975 Courtaboeuf Cedex France Tel 33 169 821 400 Fax 33 169 821 532 Covidien Ireland Commercial Ltd Block G Ground Floor Cherrywood Technology Park Loughlinstown County Dublin Ireland Tel 353 1 4381613 Puritan Bennett 560 Ventilator Clinician s Manual Technical Service Contacts Covidien Israel 5 Shacham St North Industrial Park Caesarea 38900 Israel Tel 97 246 277 388 Fax 97 266 277 688 Covidien Mexico Calz Ermita Iztapalapa 1514 Col Barrio San Miguel Del Iztapalapa Mexico D F 09360 Mexico Tel 5255 5804 1524 Fax 5255 5685 1899 Covidien Panama Parque Industrial Costa del Esta Calle Primera Edifio 109 Panama City Panama Tel 507 264 7337 Fax 507 236 7408 Covidien Puerto Rico Palmas Industrial Park Road 869 Km 2 0 Bdlg 1 Catano PR 00962 Tel 787 993 7250 Ext 7222 amp 7221 Fax 787 993 7234 Covidien South Africa Corporate Park North 379 Roan Crescent Randjespark Midrand South Africa Tel 27 115 429 500 Fax 27 115 429 547 Covidien Switzerland Roosstr 53 Wollerau 8832 Schweiz Tel 41 17865050 Fax
177. for the higher frequency range applies The ISM industrial scientific and medical bands between 150 kHz and 80 MHz are 6 765 MHz to 6 795 MHz 13 553 MHz to 13 567 MHz 26 957 MHz to 27 283 MHz and 40 66 MHz to 40 70 MHz An additional factor of 10 3 is used in calculating the recommended separation distance for transmitters in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2 5 GHz to decrease the likelihood that mobile portable communications equipment could cause interference if it is inadvertently brought into patient areas These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people B 13 Puritan Bennett 560 Ventilator Clinician s Manual Specifications Table B 24 Compliant Cables and Accessories Cable or Accessory UK AC power cable assembly Japan AC power cable assembly China AC power cable assembly 18m GIN sm r64i sm 6a FOngeninltcomector o PFiozmessurementkt FiO2 sensor Pe l B 11 Standards Compliance and IEC Classification General Standards e Medical Electrical Equipment General Requirements for Safety IEC 60601 1 1990 and EN 60601 1 1990 and all its amendments up to 1995 e The ventilator will be constructed to comply with the following product Classifications as detailed in Clause 5 of 60601 1 e Class Il Equipment e Internally Powered Equipment e Type
178. for use on commercial aircraft per FAA requirements Refer to chapter B 11 Standards Compliance and IEC Classification Patients traveling with the Puritan Bennett 560 Ventilator may be required by their airline to demonstrate evidence of compliance with the RTCA DO 160F standard as well as other requirements Contact your airline prior to travel to determine airline specific requirements and documentation A N WARNING Even though the Puritan Bennett 560 Ventilator meets current safety standards the internal Lithium ion battery of the device exceeds the 100Wh threshold and is therefore considered to be Dangerous Goods DG Class 9 Miscellaneous when transported in commerce As such the Puritan Bennett 560 Ventilator and or the associated Lithium ion battery are subject to strict transport conditions under the Dangerous Goods Regulation for air transport IATA International Air Transport Association International Maritime Dangerous Goods code for sea and the European Agreement concerning the International Carriage of Dangerous Goods by Road ADR for Europe Private individuals who transport the device are excluded from these regulations although for air transport some requirements apply For air transport the Puritan Bennett 560 Ventilator is permitted as checked in or carry on baggage Two spare batteries per person may be taken on board as carry on luggage only with the prior approval of the airline This classification and
179. ful life of the battery Do not store the internal battery for extended periods without recharging as this may reduce the maximum life To connect the ventilator to an external power source first ensure the ventilator s I O switch is off O Then connect the desired power cable to the ventilator Finally connect the power cable to the external power source To disconnect the ventilator from an external power source first power down the ventilator Then disconnect the power cable from the external power source and finally the ventilator Connect the external DC power source by first connecting the power cable to the ventilator and then to the external DC source Follow the reverse procedure to disconnect the device from the external DC power source Connect the external electrical power source by first connecting the power cable to the ventilator and then to the external power source Follow the reverse procedure to disconnect the device from electrical power sources AN Warnings Regarding Oxygen The ventilator must not be used with flammable anesthetic substances Oxygen therapy for patients with respiratory failure is a common and effective medical prescription However be aware that inappropriate oxygen use may potentially lead to serious complications including but not limited to patient injury Strictly follow the instructions provided in section 6 8 2 Connecting the Oxygen Supply which include the use of a flow r
180. ger an alarm if the tidal volume expired by the patient is lower than the minimum threshold set LOW VTE alarm or greater than the maximum threshold set HIGH VTE alarm Refer to chapter 5 Alarms and Troubleshooting Min VTE and Max VTE are linked to Vt so that Vt must be greater than Min VTE by at least 10 ml but lower than Max VTE by at least 10 ml If Vt is changed Min VTE and Max VTE are automatically readjusted so that the difference between them is always maintained VTE is displayed when ventilating with an exhalation valve Setting Min VTE and Max VTE is not mandatory they can be set to OFF which is the default setting but the measured value is always displayed when using double limb configurations Max Rtot Max Alarm Setting TOTAL BREATH RATE The maximum rate threshold set monitors the risk of hyperventilation or ventilator autotriggering Its setting is used to trigger the HIGH RATE alarm Refer to chapter 5 Alarms and Troubleshooting When set the Max Rtot threshold must always exceed the Rate setting by at least 5 bpm If the Rate is readjusted the Max Rtot is automatically readjusted to maintain a minimum difference of 5 bpm Setting the Max Rtot is not mandatory it can be set to OFF the default setting but the measured value is always displayed FIO2 Min and or Max Alarm Settings FRACTION OF INSPIRED OXYGEN An FiO sensor connected to the patient circuit allows
181. guration The Ventilation parameters adjustable in P A C mode are listed in Table 3 5 Puritan Bennett 560 Ventilator Clinician s Manual 3 9 Operating Parameters Table 3 5 Ventilation Parameters in PA C Mode Menu Min Value Max Adjustment Default Linked Value Resolution Value Parameters Standby 2 Standby 55 Valve configuration 5 Valve configuration 55 1 15 PEEP Leak configuration 6 Leak configuration 30 Standby OFF cmH 0O anaby mbaror Valve configuration OFF hPa Leak configuration 4 Rate Rise Time 1 4 1 2 I T Max Rtot Rate bpm 5 1 13 i E 1 4 1 1 1 0 1 1 2 S aN 20 50 1 33 Min VTE Max VTE VT Target 2000 Min VTI Max VTI Table 3 6 lists the adjustable alarm parameters in P A C mode Table 3 6 Alarm Parameters in P A C Mode Min Max Adjustment Default Linked a PA a E OO Minn VTI 2 2 000 en VTI Min VTE 1 990 Max VTE with exhalation valve Max VTE 3 000 10 1000 Min VTE with exhalation valve Max Leak leakage configuration ee aa ae PIP Peak Inspiratory Pressure When Relative Pressure is set to YES in the Setup Menu PIP allows you to determine inspiratory pressure added to PEEP during the inspiratory phase 3 10 Puritan Bennett 560 Ventilator Clinician s Manual P A C Mode Parameters and Setting Ranges In this configuration the sum of PIP and PEEP must not exceed 55 mbar When Relative Pressure is set to OFF in the Se
182. h memory setting POST FLASH Checksum Error Startup FLASH computed checksum does not match memory setting POST EEPROM Error Startup EEPROM does not match memory setting POST Reference Voltage Error 5V or 10V reference voltage error Incorrect software version detected Internal battery capacity is less than 10 min or 3 battery operation overextended Restart ventilator to see if alarm clears If not replace the ventilator and call your customer service representative Restart ventilator to see if alarm clears If not replace the ventilator and call your customer service representative Restart ventilator to see if alarm clears If not replace the ventilator and call your customer service representative If patient has been disconnected reconnect patient to reset the fault If persists restart ventilator to see if alarm clears If not replace the ventilator and call your customer service representative Restart ventilator to see if alarm clears If not replace the ventilator and call your customer service representative Restart ventilator to see if alarm clears If not replace the ventilator and call your customer service representative Restart ventilator to see if alarm clears If not replace the ventilator and call your customer service representative Restart ventilator to see if alarm clears If not replace the ventilator and call your customer service representative Reconnect
183. he patient circuit including all hoses is not damaged or obstructed A ventilator dependent patient should always be monitored by trained and competent medical personnel Ensure that the patient s caregiver is able and prepared to take suitable action in the event the ventilator identifies an alarmed condition or experiences a problem Do not use a patient circuit with a leak accessory for ventilator dependent patients Before dispensing the ventilator to caregivers or the patient for home use ensure the Locking Key is activated so that critical ventilator settings are not modified Do not perform ventilator alarm tests while the patient is connected to the ventilator Provide the patient with an alternate means of ventilation before conducting these tests Verify the functionality of the alarm conditions before connecting the patient to the ventilator Refer to chapter F Alarms Tests If the ventilator fails the alarm tests or if you cannot complete the tests refer to chapter 5 8 Troubleshooting or call your equipment supplier or Covidien When an alarm condition is triggered or there is evidence of a patient ventilator fault or problem examine the patient first before examining the ventilator A continuous alarm condition will be activated if the ventilator power switch is turned off while ventilation is in progress When the power switch is turned back on again ventilation will resume without having to press the VENTI
184. he Min I Time so that the Min Time setting cannot be greater than half the inspiratory phase of a cycle triggered by the ventilator If Backup R is changed Min Time is if necessary automatically readjusted so that the difference between them is always maintained The minimum time by default if no parameter is set Min Time AUTO corresponds to the lower value in the range of the Rise Time to which an operating margin of 0 3 seconds is added See Rise Time on page 3 3 for details about Rise Time Max Time defines the maximum duration of time during which the inspiratory phase is maintained The switch over to exhalation occurs at the latest after this time has expired By default if no parameter is set the maximum time Max Time AUTO is the shortest time between a fixed time of three 3 seconds and half the duration of the patient s inspiratory breaths expressed in seconds AUTO equals Rise Time 0 3 seconds This default value will be applied if it is lower than the Max Time setting Min Time and Max Time are related so that the Max Time cannot be set to a value lower than the Min Time Puritan Bennett 560 Ventilator Clinician s Manual 3 5 Operating Parameters 3 6 VTI Min and or Max Alarm Settings INSPIRATORY TIDAL VOLUME It is possible to set a minimum and or maximum Tidal Volume alarm threshold for the patient s inspired tidal volume during a cycle This setting is used to trigger
185. ibar which is a unit of measure for atmospheric pressure Mean Airway Pressure Average patient pressure during each breath Minimum Exhalation Time Minimum exhalation time before allowing the patient inspiratory trigger Minimum Inspiratory Time Minimum inspiratory time before allowing the patient to exhale M Vol Minute Volume Flow delivered at each breath to the patient is measured by the inspiratory flow sensor and that measurement is used to calculate minute volume Vt x Rtot P A C Pressure Assist Control A ventilator mode which provides machine initiated breaths delivered at a clinician set pressure inspiratory time and rate Patient Breath Breathing cycle initiated by the patient Puritan Bennett 560 Ventilator Clinician s Manual Patient Counter Counter of ventilation time for the patient Patient effort Inspiratory effort initiated by the patient Patient circuit Tubing between the ventilator and the patient Pause Waveforms freezing function PAW Peak Airway Pressure The Peak Airway Pressure is the average peak pressure during the inspiratory phase measured by each cycle and over the previous 24 hour period Peak Inspiratory Pressure PIP The highest pressure measured in the patient circuit during the inspiration phase Positive End Expiratory Pressure PEEP Pressure in the patient circuit at the end of expiration Pressure Control P Control Augmentation of the patient s ven
186. ient To ensure proper servicing and avoid the possibility of physical injury to personnel or damage to the ventilator only personnel authorised and qualified by Covidien should attempt to service or make authorised modifications to the Puritan Bennett 560 Ventilator 5 8 1 Alarms Table 5 2 offers a guide to the most likely ventilator alarms possible reasons for the alarms and corrective actions WARNING Except for replacing the internal battery and performing the recommended maintenance described in Chapters 8 through 10 of this manual do not try to repair or otherwise service the ventilator yourself or modify the ventilator its components or accessories Doing so might endanger the patient cause damage to the ventilator and or void your warranty Only qualified service personnel should attempt repair of the ventilator When an alarm condition is triggered or there is evidence of a patient ventilator fault or problem examine the patient first before examining the ventilator Note The ventilator screen must be unlocked before setting and parameters can be changed Table 5 2 Alarms and Corrective Actions Alarm Message or Possible Reason s For The Alarm Event Corrective Action s Symptom BATTERY FAULT1 Battery problem that prevents it from RESTART SRVC operating Cancel the alarm then check the supply cable and or the effective availability of a ee voltage on the AC power mains port AC mains
187. ient circuit used HP Ves No Remove exhalation valve to start CPAP ventilation 5 13 Puritan Bennett 560 Ventilator Clinician s Manual Alarms and Troubleshooting Table 5 1 Overview of Alarms Continued Alarm Message REMOVE VALVE OR CHANGE PRES SOFTWARE VERSION ERROR TURB OVERHEAT RESTART SRVC UNKNOWN BATTERY VALVE MISSING CONNECT VALVE VTI NOT REACHED IF PERSISTS RESTART SRVC Cause Ventilator Response The ventilation settings are not compatible with the type of patient circuit used With a valve circuit the difference between PIP and PEEP should not be less than 5 mbar Detection of a wrong software version Turbine speed too low and temperature too high Consequence ventilation stops immediately and O supply stops The internal battery is not recognised as a Puritan Bennett product battery Connect exhalation valve to start ventilation in V A C or V SIMV P SIMV modes Measurement and calculation of tidal volume do not match Vt set during six consecutive breaths in VOL inspired and V SIMV modes Alarm activation occurs e After six consecutive breaths once the ventilator has reached its performance limits Priority Puritan Bennett 560 Ventilator Clinician s Manual Alarms and Troubleshooting 5 8 Troubleshooting uN WARNING This manual tells you how to respond to ventilator alarms but it does NOT tell you how to respond to the pat
188. iew see ead onidecaenuedeseaaagee wanders 5 15 5 8 2 Additional Troubleshooting 5 25 Installation and Assembly ccccccccccccccccccccece 6 1 6 1 Installing the Ventilator 0 0 ccc ccc cece eect eees 6 1 6 2 Connecting to External AC Power c cece eens 6 2 6 3 Connecting to an External DC Power Source 6 4 6 4 PANE CCE e rE E Eaa 6 6 6 4 1 Choosing the Patient Circuit Type 6 6 6 4 2 Installing the Patient Circuit 6 6 6 5 o EEEE TEEN E TEATE EEE TTTS 6 10 6 6 Humidifier snnnnnunnnnnnesusnrnesesnereresoerene 6 12 6 7 Exhalation Block 4 ciira aw econ ceriseedegeeeeereseseapansas 6 12 6 8 Ora E E EEE ee ee ee ee ee 6 13 6 8 1 Administering Oxygen ccc cece eee eens 6 14 6 8 2 Connecting the Oxygen Supply 6 14 6 8 3 Connecting the FIO2 sensor 0065 6 16 6 9 Mounting the Ventilator on a Wheelchair 6 17 6 10 Mounting the Ventilator on the Utility Cart 6 18 6 11 Connecting the Nurse Call Cable 0000 6 19 Operating Procedures ccc ceccccccccccccccccccccccees 7 1 7 1 Turning on the Ventilator ccc ccc cece eee ees 7 1 7 2 Setup Menu Parameters 0 cece cc eee eee e ences 7 3 7 2 1 Accessing Setup Configuration 065 7 3 7 2 2 Changing the Setup Menu Parameters 7 4 7 2 3 Exiting the Setup Screen
189. il 828m o PEEP 10 mbar a vti 1055mL o Rise Time 72 1 Me Leak 0 0 Lpr u Rise Time 2 1 BE Leak 0 01pm o R Rate 43 bpm f Mol 0 0L o R Rate 13 bpm te M vol 0 0L o IE 1 2 0 ME Rate 25 bpm o IE 1 2 0 BE Rate 16bpm o Insp Sens OFF J IE 41 2 0 o Insp Sens OFF ji IE 41 2 4 ovtTarget OFF BE ioo ovtTarget OFF WE o o Preferences mbar O Preferences mbar Figure 7 5 Absolute and Relative Pressure Pressure Unit The unit of pressure can be set here It can be displayed as mbar cmH20 or hPa E Sens Settings E Sens enables the operator to adjust the sensitivity of the expiratory trigger in pressure support breaths in PSV P SIMV and V SIMV modes which will cycle the breath into the expiratory phase During a Pressure Support inspiration the delivered flow will reach a peak value and then begin to decelerate toward zero The E Sens setting allows the operator to set the flow value as a percentage of peak flow that will cycle the breath to exhalation The E Sens setting can be set to either POSITIVE or NEGATIVE If set to POSITIVE E Sens is based on the percentage of inspiratory peak flow If set to NEGATIVE E Sens is based on the percentage of inspiratory peak flow by which the flow must decrease before exhalation is declared 120 Insp 80 40 V LPM 6 Sec 40 80 120 Exh VEN_IDIBE_A Figure 7 6 E Sens Settings Patient Hours The value of this parameter is equal to the total number of hours that th
190. ilator but it does NOT tell you how to respond to the patient e While the ventilator is in use an alternative means of ventilation should always be available in the event of a ventilator problem This is particularly true for ventilator dependent patients Supplementary observation appropriate for the patient s condition is also recommended e To ensure that ventilation continues uninterrupted ensure alternative power sources are available AC power source extra batteries or an auxiliary DC car adapter Be prepared for the possibility of power failure by having an alternative means of ventilation ready for use particularly for ventilator dependent patients e Donotallow a patient to remain connected to the ventilator when ventilation is stopped because a substantial quantity of exhalation gas primarily carbon dioxide may be inhaled by the patient In some circumstances inhaling carbon dioxide may lead to under ventilation suffocation and serious injury or death e The ventilator must not be used with flammable anesthetic substances Puritan Bennett 560 Ventilator Clinician s Manual 1 1 Safety Information 1 2 Do not start ventilation until you ensure that the device is suitably assembled that the air inlet filter is properly installed and is not obstructed and that there is proper clearance all around the unit Also ensure that the patient circuit is suitably connected to both the ventilator and the patient and that t
191. ilators for Ventilator Dependent Patient EN 1S010651 2 2009 Lung Ventilators for Medical Use Particular Requirements for Basic Safety and Essential Performance Part 1 Home Care Ventilator Support YY 0600 1 2007 ISO 10651 6 2004 MOD Lung ventilators for medical use Particular requirements for basic safety and essential performance Part 2 Home care ventilators for ventilator dependent patients YY 0600 2 2007 ISO 10651 2 2004 MOD Medical electrical equipment Part 2 Particular requirements for the safety of lung ventilators Critical care ventilators GB 9706 28 2006 IEC EN 60601 2 12 2001 MOD Anesthetic and respiratory equipment Conical connectors Part 1 Cones and sockets EN ISO 5306 1 2004 Air Transportation Standards Environmental Conditions and Test Procedures for Airborne Equipment RTCA DO 160 2007 Puritan Bennett 560 Ventilator Clinician s Manual B 15 Specifications This page intentionally blank B 16 Puritan Bennett 560 Ventilator Clinician s Manual C 1 C 2 Architecture Theory of Operation Architecture The Puritan Bennett 560 Ventilator s gas delivery system is primarily composed of an airflow generator and a three way valve to control the patient circuit exhalation valve The flow generator is a low inertia micro turbine driven by a brushless DC electric motor while the three way valve is a proportional solenoid valve These two actuators are microprocess
192. inactive mode and the current mode remain in memory until some or all of the parameters are modified again this is true even after the machine is stopped Setting Ventilation Parameters Ventilation parameters can be changed as long as the Locking Key is not activated refer to section 7 9 Unlocking the Control Panel on page 7 26 WARNING In adult or pediatric use ensure that the adjusted tidal volume is compatible with the needs of the patient Ventilation is not interrupted by the adjustment of a value It continues according to previous settings The new settings are applied ONLY after they are confirmed and synchronised in the next breath cycle except for the Sens setting which is applied immediately To modify a ventilation parameter 1 o the cursor on the line of the parameter to be modified using the UP q a or DOWN A v ey 2 Validate your intention to modify the parameters using the ENTER GA button Refer to the figure below e The cursor changes to item 1 below e The parameter value flashes item 2 below e Azoom ofthe parameter value is displayed in the right side of the window item 3 below 2 i PB560C60 o P A C ABS 1 gt PIP 15 mbar oO PEEP OF o Rise Time 72 o Rate 43 bpm js o IE 1 2 0 a 1 5 lt L 3 o l Sens 2 ovtTarget OFF o Preferences Ps Oe Figure 7 20 Modifying a Ventilation Parameter 3 Press UP 24 or DOWN 7 to select the value desir
193. indicates 00000h as shown in the following graphic Puritan Bennett 560 Ventilator Clinician s Manual 7 7 Operating Procedures 7 3 7 8 PB560C80 SETUP Machine Hrs 00000h o Language ENGLISH o Date 01 JAN 2059 o Time 02 12 04 o Cycling Mode mH o Relative pressure YES o Pressure Unit mbar o E Sens Settings POSITIVE o Patient Hours 00000h Ormin Reset Hours OFF O Maintenance Figure 7 9 Resetting Patient Hours to Zero 3 6 Press UP 4 or DOWN a Y e The display indicates Reset Hours OFF as shown in the following graphic SETUP PB560C52 Machine Hrs 00000h m Language ENGLISH O Date 01 JAN 2099 o Time 00 30 39 o Cycling Mode aH o Relative pressure OFF o Pressure Unit mbar o E Sens Settings POSITIVE o Patient Hours 000001 V E o Reset Hours OFF o Maintenance Figure 7 10 Resetting Patient Hours to Zero 4 Maintenance This option is reserved for maintenance operators qualified by Covidien to ensure correct maintenance and operation of the device For information on using the Maintenance option refer to the Puritan Bennett 560 Ventilator Service Manual 7 2 3 Exiting the Setup Screen To exit the SETUP Screen you must cycle the ventilator s power 1 Set the ventilator s rear panel I O switch to OFF O Wait 30 seconds 2 Set the ventilator s I O switch ON I The ventilator will run through a Power On Self Test
194. ing and cancelling alarms and setting device and alarm parameters FiO Sensor Connection Connection for FiO sensor which monitors the amount of oxygen in the patient circuit Patient Connection Port Provides an outlet for the gas to be delivered to the patient via the patient circuit Patient Pressure Monitoring Port Nipple for monitoring proximal patient pressure a If exhaled tidal volume monitoring is required use the double limb circuit 2 4 if E a COVIDIEN Puritan Bennett 560 Ventilator VEM_10025_ A Exhalation Valve Port Nipple for providing piloting pressure to the exhalation valve Controls the open closed position of the exhalation valve Lateral and Front Openings Vents that allow for air circulation to cool the ventilator s internal components In addition these openings function as sound ports for audible alarms A N WARNING Do not cover or obstruct these openings From Patient Port Exhaled volume measurements are taken from this port through which a portion of the exhaled gas is diverted to the exhalation flow sensor VTE is calculated from this flow measurement Exhaled Gas Outlet Exhalation Valve connects here Figure 2 1 Front Panel Puritan Bennett 560 Ventilator Clinician s Manual 2 6 Back Panel 1 2 3 11 F 4 AILE i VEN_10023_B 10 9 8 7 6 5 1 Ergonomic carrying handle 7 PC Cable Connector USB mini B connector u
195. ing continuous recording If the memory capacity on the USB memory device is insufficient the message TRANSFER NOT ALLOWED USB CAPACITY INSUFFICIENT is displayed and data transfer is not allowed Delete the data on the USB memory device before restarting data transfer Refer to deletion process Refer to chapter 7 7 5 Erase Data from the USB Memory Device In case of USB memory device disconnection or transfer error the message TRANSFER ERROR USB DISCONNECTION or TRANSFER ERROR TECHNICAL PROBLEM is displayed In this case restart the transfer process If the problem persists contact your technical service 7 7 4 Transfer Trends Up to one year s worth of trend data can be transferred from a ventilator to a USB memory device Ventilation trends such as leaks VTI VTE Rate I E M Vol PIP and PEEP measurements can be transferred from the ventilator to a USB memory device The data can be accessed by a doctor or service provider using the Puritan Bennett respiratory insight software Puritan Bennett 560 Ventilator Clinician s Manual 7 23 Operating Procedures 7 24 PB560C73 PB560C74 USB MEMORY DEVICE USB MEMORY DEVICE SiN 40966K0001 SiN 40966K0001 o Transfer Continuously OFF Transfer Continuously OFF Transfer Trends 3 months Transfer Trends 3 months o Erase Key OFF Erase Key OFF TRANSFER IN PROGRESS Remaining Time Oh Omin m Stop Figure 7 26 Sel
196. ings VTI Min and or Max Alarm Settings INSPIRATORY TIDAL VOLUME It is possible to set a Min and or Max Tidal Volume alarm threshold for the patient s inspired tidal volume Puritan Bennett 560 Ventilator Clinician s Manual 3 21 Operating Parameters This setting is used to trigger an alarm if the Tidal volume inspired by the patient is lower than the minimum threshold set LOW VTI alarm or greater than the maximum threshold set HIGH VTI alarm Refer to chapter 5 Alarms and Troubleshooting Min VTI and Max VTI are related and their setting must maintain a minimum difference of 20 ml between them It is not mandatory to set the minimum and maximum VTI alarm limits When the minimum and maximum VTI alarm limits are not set the display will read OFF for these settings VTE Min and or Max Alarm Settings EXPIRED TIDAL VOLUME A Min and or Max Tidal volume expired by the patient can be set but can only be used in a double limb circuit configuration These thresholds can be set to trigger an alarm if the Tidal volume expired by the patient is lower than the minimum threshold set LOW VTE alarm or greater than the maximum threshold set HIGH VTE alarm Refer to chapter 5 Alarms and Troubleshooting Min VTE and Max VTE are related and their settings must be set to values that maintain a minimum difference of 20 ml between them VTE is displayed when ventilating with an exhalatio
197. inspiratory trigger has been detected e The Backup R value applied depends on the Rate setting Hence Backup R is at least equal to 8 bpm and is equal to the Rate value if Rate is greater than 8 bpm Insp Time INSPIRATORY TIME CONTROLLED Insp Time allows you to determine the duration of the inspiratory phase of controlled breaths triggered by the ventilator and is limited to a 1 2 I E ratio Backup R and Insp Time are related Sens INSPIRATORY TRIGGER SENSITIVITY Sens allows you to set the level of inspiratory effort the patient has to provide to initiate a machine breath The sensitivity levels decrease from 1P to 5 the lower the number the more sensitive the trigger sensitivity These levels correspond to differences in flow compared to the bias flow Sens 1 P Bias flow 0 4 lpm to 1 lpm P Pediatric use Sens 2 Bias flow 0 7 lpm to 1 3 lpm Sens 3 Bias flow 0 9 lpm to 1 5 lpm Sens 4 Bias flow 1 0 lpm to 1 6 lpm Sens 5 Bias flow 1 2 lpm to 1 8 lpm The bias flow consists of turbine flow through the patient circuit during the exhalation phase that helps the patient avoid rebreathing exhaled gas CO3 The inspiratory trigger is initiated after a time delay of between 700 ms to 1500 ms depending on the preceding peak inspiratory flow Sens can be set to OFF A WARNING The inspiration trigger threshold should be carefully modified in order to avoid the risk o
198. ion Figure 7 12 Changing Settings in the Preferences Menu To change the settings in the Preferences menu 1 Press UP 4 to place the cursor on the parameter line to be modified 2 Press ENTER Cy e The cursor changes to the plus minus W symbol e The parameter selected to be modified flashes or for certain parameters featuring a bar graph the indicator triangle under the bar graph becomes filled Refer to the following graphics PB560C101 PB560C100 Waveforms display OFF Alarm Yolume i Cursor Parameter value Indicator triangle plus minus symbol flashing filled Puritan Bennett 560 Ventilator Clinician s Manual 7 9 Operating Procedures 3 Press UP 4 or DOWN Y to change the selected parameter s value 4 Press ENTER WY to confirm the new parameter setting e The new parameter setting is displayed e The cursor returns to its initial form If a parameter change is not confirmed by pressing ENTER WY before seven 7 seconds elapse the ventilator resets the parameter to its previous value The parameters in this menu are e Backlight e Contrast e Alarm Volume e Key Sound e Intentional Vent Stop Alarm e Apnea Alarm e Disconnection Alarm e Waveforms Display e Pediatric Circuit e Ventilation Report To adjust the various Preferences menu parameters or to view the Ventilation Report refer to the instructions provided in this section To manually exit from the Preferences menu e
199. ion B 14 ventilator B 7 Standards compliance and IEC classification specifica tions B 14 Starting ventilation 7 26 Stopping ventilation 7 28 Storing the internal battery 8 5 Stud oxygen connector 7 9 6 175 T Target Tidal Volume 3 5 Target tidal volume 3 5 3 12 Technical faults 5 7 Puritan Bennett 560 Ventilator Clinician s Manual Test tube figure 70 7 Testing internal battery 8 4 F 4 Transfer continuously USB Memory Device 7 22 Transfer Trends USB Memory Device 7 23 Transport emergency ventilator not intended for 2 2 Trigger threshold setting modifying Caution 3 3 Troubleshooting alarms 5 15 other problems 5 25 TURB OVERHEAT alarm message 5 14 5 25 Turning off the ventilator 7 29 Turning on the ventilator 7 7 U Unfreeze function Unfreezing a waveform trace 4 7 UNKNOWN BATTERY alarm message 5 14 5 25 Unlocking the keyboard 7 26 Unpacking and preparing the ventilator G 7 USB Memory Device Characteristics 7 22 Erase Data 7 25 Specifications 7 22 Supported formats 7 22 Transfer continuously 7 22 Transfer Trends 7 23 USB Menu 7 22 USB Menu parameters 7 21 V V A C mode 3 14 V A C Mode Menu alarm parameters 3 14 V SIMV mode 3 23 V SIMV Mode Menu Alarm parameters 3 24 Ventilation parameters 3 23 VALVE MISSING CONNECT VALVE alarm message 5 14 5 25 VENT STDBY indicator 7 2 Ventilation menu 2 7 Starting 7 26
200. irm a change by pressing ENTER WY before seven 7 seconds elapse the ventilator restores the setup field s previous value The parameters in this menu are Machine Hours Language Date Time Cycling Mode Relative pressure Pressure Unit E Sens settings Patient Hours Maintenance Machine Hours The counter records the total ventilation time in hours to the nearest hour since manufacture Note The machine hour meter is reset when the CPU board is changed Puritan Bennett 560 Ventilator Clinician s Manual Setup Menu Parameters Language The language can be set here All messages and denominations are automatically displayed in the selected language The languages available are Table 7 1 Languages Engish US Engish UK tosh e Swedish Korean Date The current date can be set here The date is displayed in the format DD MMM YYYY Time The current time can be set here The time is displayed in the format HH MM SS Cycling Mode The cycling mode determines the duration of inspiratory time in P A C and V A C It can be set to either I E or I T and enables the operator to set the duration of inspiratory and exhalation phases The two cycling modes represent the relationship between inspiration time to exhalation time as follows 1 I T Inspiratory time Ti as a percentage of the total breath cycle time Ti Te I T Ti Ti Te x 100 2 1 E The inspiration time Ti to exhalati
201. is intended for single use by a single patient It may periodically be cleaned but it cannot be disinfected or sterilised To maintain good measurement quality when used continuously clean the exhalation block periodically refer to section 9 3 Cleaning the Exhalation Block on page 9 2 The exhalation block should be changed every 4 months and cannot be reused with any other patient Ensure that the exhalation block is completely dried after cleaning and prior to use Puritan Bennett 560 Ventilator Clinician s Manual Oxygen The exhalation block can be easily removed from the device for inspection cleaning and replacement No special tools are required It is held in place by a single captive screw located on the bottom of the device To remove the exhalation block Refer to Figure 6 14 if required 1 Ensure the ventilator is turned off 2 Loosen the captive screw located on the bottom of the ventilator that secures the exhalation block Figure 6 14 item 1 Grasp the exhalation port and slide the exhalation block to the left to remove it from its slot Figure 6 14 item 2 Figure 6 14 Removing the Exhalation Block After removal the exhalation block can either be cleaned or if required replaced with a new one For information on cleaning refer to section 9 3 Cleaning the Exhalation Block To install either a cleaned or a new exhalation block Refer to Figure 6 14 if required 1 Slide the exhala
202. is momentarily displayed as a percentage Then after the ventilator calculates the battery time remaining which takes about two minutes depending on the power consumption of the ventilator the internal battery reserve is then displayed in hours and minutes rounded to the nearest fifteen minutes Refer to Figure 8 3 a PC P AC REL 04h124 o PIP 15 mbar o PEEP OF o Rise Time 2 B Leak 0 0 Lpm o Rate 13bpm k M vol 0 0L o lE 1 2 0 m Rate 18bpm olSens 2 M E 1 24 ovtTarget 120 mL B ee gt Max P 48 mbar o Preferences bar Figure 8 3 Battery Reserve Capacity in Hours and Minutes The LOW BATTERY and EMPTY BATTERY alarms refer to chapter 5 Alarms and Troubleshooting are triggered when the internal battery reserve is reduced AN WARNING Due to its limited internal battery s reserve capacity the ventilator should only be operated on the internal battery when no other power source is available Ensure that the internal battery never becomes fully discharged When the LOW BATTERY alarm is triggered immediately connect the ventilator to an AC power supply to maintain ventilation and recharge the internal battery From the time that an EMPTY BATTERY alarm is activated if no external supply is connected to the ventilator other alarms may be triggered due to insufficient supply voltage In the final discharge phase the EMPTY BATTERY alarm will become continuous and v
203. item 3 between the patient wye item 5 and the inlet port of exhalation bacteria filter item 12 7 Connect the exhalation bacterial filter item 12 between the FROM PATIENT cK inlet port item 10 and the exhalation limb of the patient circuit 8 Connect one end of the small proximal pressure tubing item 6 to the double limb patient wye circuit connection item 5 and the other end on the ventilator patient pressure port item 13 9 Place the exhalation valve assembly item 9 on the exhaust port 10 Connect the tubing item 8 from the exhalation valve assembly to the exhalation valve port item 13 of the ventilator Note When shipped the proximal pressure tube may already be connected to the patient wye If so simply verify that the connection is secure and the tube shows no signs of damage kinks or obstructions 11 See also Figure 6 9 on page 6 9 14 een settee D TD Dy eee nee MTT TTT TTTTITITTTTTTTTTTTTTTTTTT E Serres rer iri TEE LL VEN 10032 C 3 Figure 6 8 Double Limb Patient Circuit Note Although shown here the humidifier item 2 water traps item 3 and their connecting tubes are not included with the patient circuit or ventilator Contact your supplier for more information 6 8 Puritan Bennett 560 Ventilator Clinician s Manual Patient Circuit Inhalation Port Exhalation Valve Tube VENA Proximal Pressure Tube Figure 6 9 Close up of Exhalation Va
204. key to place the cursor on the FiO setup line 6 Press the ENTER GA key twice to access the Patient column central column of the FiO setup line e OFF flashes in the central column e Azoom of OFF is displayed flashing in the window on the right e The message FIO2 Calibration is displayed in the window on the right i Min Current Max j OPIP mbar o Rtot bpm iim OFF eldi o Alarms Logs Figure 10 6 Calibrating the FiO2 Sensor 2 7 Press the UP q a or DOWN a v_ key YES is displayed instead of OFF f min Current Max o Alarms Logs Figure 10 7 Calibrating the FiO2 Sensor 3 8 Press the ENTER CY key to start calibration 10 4 Puritan Bennett 560 Ventilator Clinician s Manual Replacing the Air Inlet Filter e The message FIO2 calib Processing is displayed in the window on the right while calibration is in process FiO2 calib Processing o Alarms Logs Figure 10 8 Calibrating the FiO2 Sensor 4 e Ashort beep sounds to confirm that the FiO sensor has been calibrated 9 Press the ENTER G4 key to exit the FiO setup line Note The FiO sensor calibration procedure once initiated must run to its conclusion In the event of calibration errors the following events occur e Analarm is activated and the message FIO2 CALIBRATION FAIL is displayed e The ventilator takes the previously saved value as the default For more informati
205. lation phase Fraction of Inspired Oxygen FiO5 Amount of oxygen delivered to the patient Puritan Bennett 560 Ventilator Clinician s Manual FiO Sensor The sensor which measures the amount of oxygen being delivered to the patient Flow Volume of gas delivered by the ventilator compared to time expressed in litres per minute lpm Flow Pattern Ramp Setting This is the flow distribution shape during the inspiration phase There are three flow patterns available Square waveform or constant flow Decelerated sawtooth waveform or decreasing flow and Sinusoidal flow Freeze Interruption of the waveform plot tracing on the ventilator s display hPa An abbreviation for hectopascal which is a unit of measure for atmospheric pressure LE ratio Inspiratory time versus exhalation time ratio Inspiratory Phase Phase of the breath cycle during which the patient inspires Inspiratory Sensitivity I Sens Level of inspiratory effort the patient has to provide during the initiation of a machine breath The sensitivity levels from 1P to 5 correspond to differences in flow compared to the bias flow Level 1P is the most sensitive for a pediatric use and requires the least effort to trigger a breath Level 5 requires the most amount of effort to trigger a breath Inspiratory Tidal Volume VTI Volume delivered to the patient at each inspiratory phase Time Inspiratory Time Inspiratory time measure Inten
206. lator Settings Range Resolution and Accuracy Inspiratory time Insp Time Respiratory rate R Rate Inspiratory sensitivity I Sens Exhalation sensitivity E Sens Ramp Flow Pattern Rise time B 6 Range 0 3 s to 2 4 s Resolution 0 1 s Accuracy 50 ms or 10 whichever is greater Default value 1 5 s Depends on R Rate Vt in V SIMV mode Depends on R Rate in P SIMV mode Range 5 bpm to 60 bpm in V A C and P A C modes 1 bpm to 40 bpm in P SIMV and V SIMV modes Resolution 1 bpm Accuracy 1 bpm Default value 13 Depends on Insp Time and Vt in V SIMV mode Depends on Insp Time in P SIMV modes Depends on Vt in V A C mode Range 1P 5 Resolution 1 Accuracy NA Default value 2 in CPAP I Sens is set to 2 and is not adjustable Range 5 to 95 of peak flow Resolution 5 Accuracy 4 pm 10 of target exhalation flow based on E Sens within 50ms Default value 25 In CPAP E Sens is fixed at 25 and is not adjustable Range Square SQ descending ramp D sinusoidal S Resolution N A Default value Descending ramp D In V SIMV flow pattern is set to square and is not adjustable Range OFF 0 5 mbar to 20 mbar Resolution 1 mbar Accuracy 1 mbar 10 mbar Default value OFF Depends on PIP in P A C and PSV modes when Relative Pressure is set to YES Depends on P Support and P Control in P SIMV mode when Relative Pressure is set to YES Depends on P Support in V
207. le shooting or call your equipment supplier or Covidien Due to its limited internal battery s reserve capacity the ventilator should only be operated on the inter nal battery when no other power source is available Ensure that the internal battery never becomes fully discharged To turn the ventilator on e Set the I O switch a covered rocker type switch located at the rear of the ventilator to the I position as shown in Figure 7 1 below Puritan Bennett 560 Ventilator Clinician s Manual 7 1 Operating Procedures NOTE I O switch cover not shown here a LILIAN LS VEN _10043_A Figure 7 1 Turning on the Ventilator The following events occur Note The ventilator is powered on A Power On Self Test POST is carried out when plugged in to an AC power source The front panel indicators flash except for the indicator showing the type of power supply in use which remains lit The audible alarms briefly sound The display s backlight turns on The PURITAN BENNETT logo is displayed momentarily The blue VENT STDBY indicator to the right of the VENTILATION ON OFF key illuminates indicating the device is in standby mode A Welcome Menu screen is displayed for about five 5 seconds which includes the machine counter and the patient counter as shown in Figure 7 2 01 JAN 2099 HELLO 00 00 03 PB560C50 Machine 00000h Patient 00000h 00min Software version LMO01004a AL10101c
208. le other patients may require additional information The Clinician s Responsibility It is the responsibility of the clinician or clinical educator to ensure that both the patient and the caregiver fully understand the topics listed below Table A 1 Patient Caregiver Checklist Clinician Appendix G Unpacking and L Supplies required for ventilation and their sources Preparation Appendix H Parts and Accessories What to note about the patient s skin mucus a O i KORE Clinician membranes and secretions and their significance O How to recognise the signs of infection and how to respond go Whom to contact for medical emergencies equipment Clinician section 5 8 Troubleshooting emergencies or power emergencies section 10 5 Service Assistance go Equipment and phone numbers to have available in Clinician Section 10 5 Service cases of emergency Assistance Puritan Bennett 560 Ventilator Clinician s Manual A 1 Patient Caregiver Checklist Table A 1 Patient Caregiver Checklist Continued go How to contact other resources for assistance health Clinician aides attendants therapists and so on go The importance of routine medical appointments and anne medical testing Section 6 2 Connecting to External AC go Power sources for the ventilator and how to connect Power and section 6 3 Connecting to them an External DC Power Source O The meaning of keys
209. lied depends on the Rate setting If the Apnea Alarm is set to OFF in the Preferences Menu the Apnea Time setting will still be active VT Target TARGET TIDAL VOLUME VT Target allows the ventilator to deliver a target volume of gas to the patient When a VT Target is set the ventilator constantly adjusts the target inspiratory pressure between PIP and Max P to ensure the inspired tidal volume remains as close as possible to the VT target VT Target should be more than 10 ml higher than Min VTE and more than 10 ml lower than Max VTI to avoid triggering VTI or VTE alarms The minimum increase or decrease of target inspiratory pressure is 0 5 mbar and the maximum is 2 mbar Setting the Vt Target is not mandatory it can be set to OFF Max P MAXIMUM INSPIRATION PRESSURE Max P allows the ventilator to adjust the inspiratory pressure up to a maximum limit in order to reach the Target Tidal Volume Vt Target P Support and MaxP are related and the difference between them must be less than 20 mbar Max P is not displayed when VT Target is set to OFF Min and Max I Time MINIMUM MAXIMUM INSPIRATION TIME Min Time and Max Time are ventilation parameters that can be adjusted in the alarm menu Min Time defines the minimum duration of time the inspiratory phase is maintained It takes priority over activation of the exhalation trigger which can only be triggered after the Min Time has expired The Backup R is linked to t
210. lised To maintain good measurement quality when used continuously clean the exhalation block periodically The exhalation block should be changed every 4 months and AN cannot be reused with any other patient 9 2 Ensure that the exhalation block is completely dried after cleaning and prior to use The exhalation block can be removed easily from the device by first removing a captive screw accessible through the bottom of the device refer to section 6 7 Exhalation Block on page 6 12 Whenever the exhalation block is removed or after installing a new one you must calibrate the exhalation flow sensor Refer to section 10 1 Calibrating the Exhalation Flow Sensor on page 10 1 Puritan Bennett 560 Ventilator Clinician s Manual Calibrating the Exhalation Flow Sensor 10 Routine Maintenance J WARNING On a DAILY basis inspect the patient circuit to ensure that it shows no signs of damage is properly connected and is operating correctly without leakage Do not attempt to open repair or otherwise service the ventilator yourself Doing so might endanger the patient damage the ventilator and or void your warranty Only personnel authorised and qualified by Covidien should repair open or service the ventilator 10 1 Calibrating the Exhalation Flow Sensor Each time the exhalation block or circuit is removed and reinstalled or after installing a new exhalation block the exhalation flow sensor must be recalibrated
211. ll read OFF for these settings Max Leak Max Alarm Settings The setting of a high leakage threshold enables a HIGH LEAKAGE alarm to be triggered in the event the calculated leakage flow exceeds this limit The displayed value corresponds to the mean parasite leakage flow observed during the exhalation phase It is not mandatory to set the minimum and maximum LEAK alarm limits When the minimum and maximum LEAK alarm limits are not set the display will read OFF for these settings Max Rtot Max Alarm Setting TOTAL BREATH RATE The maximum rate threshold set is used to warn of hyperventilation or ventilator autotriggering The alarm setting is used to trigger the HIGH RATE alarm Refer to chapter 5 Alarms and Troubleshooting When set the Max Rtot threshold must always exceed the Backup Rate by 5 bpm If the Backup Rate is readjusted the Max Rtot is automatically readjusted to maintain a minimum difference of 5 bpm Setting the Max Rtot is not mandatory it can be set to OFF but the measured value is always displayed I Sens INSPIRATORY TRIGGER SENSITIVITY The trigger threshold for switching to inhalation cannot be set in CPAP mode The device is configured with a default Sens of 2 Puritan Bennett 560 Ventilator Clinician s Manual P A C Mode Parameters and Setting Ranges E Sens EXHALATION TRIGGER SENSITIVITY The trigger threshold for switching to exhalation cannot be set in
212. lova 1410 1 140 00 Praha Ceska Republika Tel 42 024 109 57 35 Fax 42 02 3900 0437 Covidien ECE Galvaniho 7 a 821 04 Bratislava Slovenska Republika Tel 42 124 821 45 73 Fax 42 124 821 45 01 Covidien Hellas SA 8 Fragoklisias Street Maroussi 151 25 Greece Tel 30 211 180 36 00 Fax 30 210 614 63 80 Covidien Australia 52A Huntingwood Drive Huntingwood NSW 2148 Australia Telephone 61 1800 350702 Fax 612 9671 8118 Covidien Brazil Av Na es Undias 23013 A Vila Almeida Sao Paulo SP Brasil 04795 100 Tel 5511 5683 8300 Fax 5511 5683 8349 Covidien Colombia Edificio Prados de la Morea Carretera Central Del Norte Cra 7a Kilometro 18 Chia Cundinamarca Bogota Colombia Tel 571 619 5469 Fax 571 619 5425 Covidien Danmark A S Langebrogade 6E 4 sal 1411 K benhavn K Danmark Tel 45 702 753 50 Fax 45 702 756 50 Covidien Finland Oy L kkisep ntie 23 00620 Helsinki Finland Te 35 896 226 84 10 Fax 35 896 226 84 11 Covidien Hungary 1095 Budapest Mariassy u 7 Magyarorszag Hungary Tel 36 1880 7975 Fax 36 1777 4932 Covidien Austria GmbH Campus21 Europaring F09402 Brunn am Gebrige A 2345 sterreich 43 223 637 88 39 43 223 637 88 39 40 Covidien Canada 19600 Clark Graham Baie d Urfe QC H9X 3R8 Canada Tel 1 514 695 1220 Ext 4004 Fax 1 514 695 4965 Covidien Costa Rica La Uruca 75 Metros al Oseste de Faco Oficentro La Virgen Edi
213. lve Tube and Proximal Pressure Tube Figure 6 9 shows details of the connections of the proximal pressure tube Figure 6 8 item 6 and the exhalation valve tube Figure 6 8 item 8 To connect a single limb circuit without an exhalation valve NIV only refer to Figure 6 10 l a pi oe w W Inspect the components of the patient circuit for any signs of damage such as cracks which might cause leakage Do not use damaged components to assemble the patient circuit Install the bacteria filter item 1 on the TO PATIENT Ps outlet port as shown Attach one end of the short circuit tubing item 4 to the filter item 1 Attach the other end of the circuit tubing item 4 to the inlet port of the humidifier item 2 Place a water trap item 3 between the outlet port of the humidifier and the patient end Place a vented NIV interface to the end of the patient circuit item 5 VEN_10103_A Figure 6 10 Single limb Patient Circuit Without Exhalation Valve For both types of circuits shown previously you should connect the end of the proximal pressure tube as close as possible to the patient at the mask or cannula entry if possible so that the ventilator can account for all load losses due to the circuit and its potential accessories If this is not possible it is Puritan Bennett 560 Ventilator Clinician s Manual 6 9 Installation and Assembly 6 5 best to modify the PATIENT DISCONNECTION triggering threshold by d
214. message 5 12 5 23 LOW VTI alarm message 5 12 5 23 M Machine counter 7 2 Maintenance configuration 7 3 option reserved for service personnel 7 8 schedule recommended 10 6 Manufacturer s declaration specifications B 9 Markings 7 10 7 13 Max Leak 3 6 3 8 3 13 Max P Maximum Inspiration Pressure 3 5 Max P Maximum inspiration pressure 3 72 Max Rtot 3 6 3 8 3 13 3 22 3 28 Maximum inspiration pressure 3 5 3 12 Menu alarms 2 8 Preferences parameters 7 8 ventilation 2 7 waveforms 2 9 4 6 Min Max Time 3 5 Modes ventilation Puritan Bennett 560 Ventilator Clinician s Manual setting 7 14 Modes of Ventilation D 1 Monitored parameters displayed 4 4 specifications B 3 Waveform menu figure 4 2 Monitoring digital 4 7 N NO DATA message Alarm Logs screen 5 3 NO PROXIMAL LINE2 alarm message 5 12 5 23 Notes definition of 7 7 Nurse Call cable 6 19 Nurse call system connecting the cable to the ventilator 6 19 O OCCLUSION CHECK CIRCUIT alarm message 5 12 5 24 OCCULSION CHECK CIRCUIT alarm message 5 24 Operational verification checklist E 1 Operator Users targeted for use of ventilator 2 1 O ring oxygen coupler Caution 1 9 6 15 Oxygen connecting the supply 6 14 connector stud 1 9 6 15 disconnecting the supply from the ventilator 6 16 enrichment 2 2 rear panel connector figure 6 75 special coupler 7 9 6 14 6 15
215. mum and maximum VTE alarm parameters must be properly set to warn in the event of patient disconnection Before opening the packaging for the Patient Circuit ensure that no damage is evident to the packaging or its contents Do not use if evidence of damage exists The patient circuit should not be changed during ventilation On a DAILY basis inspect the patient circuit to ensure that it shows no signs of damage is properly connected and is operating correctly without leakage Single Use accessories should not be reused The exhalation block is intended for single use by a single patient Q It may periodically be cleaned but it cannot be disinfected or sterilised To maintain good measurement quality when used continuously clean the exhalation block periodically refer to section 9 3 Cleaning the Exhalation Block The exhalation block should be changed every 4 months and cannot be reused with any other patient During invasive ventilation when an artificial airway bypasses the patient s upper respiratory system the patient s upper respiratory system cannot humidify the incoming gas For this reason the use of a humidifier to minimise drying of the patient s airway and subsequent irritation and discomfort must be used If exhaled tidal volume measurements are required to ensure correct patient ventilation a double limb patient circuit configuration must be used in order to detect leaks In this case both the minimum and
216. n 0 cece eee e eect eeees 3 1 Exhalation Trigger Sensitivity 0 0 cece ccc cece eee cece een e eee eeeeeeneas 3 4 Menus in CPAP Mode in leakage configuration cece cece cece eee ee eens 3 7 Menus in P A C Mode with exhalation valve configuration 0cceee eee 3 9 Menus in P A C Mode with leakage configuration 0c ce cece eee ee ees 3 9 Menus in the V A C Mode ccc ccc cece eee eee ence te eee eeeeeneeeeeees 3 14 Menus in P SIMV Ventilation Mode 545535 s10c00enereor ew ovewa eure ise ie se eoaKees 3 18 Exhalation trigger sensitivity sc 4224 m a scenester weak one tece eeeceeeeness ci ee wes 3 21 Menus in V SIMV Ventilation Mode ccc ccc ccc eee eee e eee eeeeeeeeees 3 23 Exhalation trigger sensitivity s10 lt lt anicraucdeesiwwssuedsatkeaas tadetetetaenataraes 3 27 Ventilation Menu Pressure Leakage Configuration Modes CPAP PSV S PSV ST PCV P A C 4 1 Ventilation Menu Pressure Valve Configuration Modes PSV S PSV ST PCV P A C 4 1 Ventilation Menu Volume Mode CV V A C SIMV 0 ccc cece cece eeees 4 2 Alarm Menu Pressure Leakage Modes CPAP PSV S PSV ST PCV P A C 4 2 Alarm Menu Pressure Valve Modes PSV S PSV ST PCV P A C cece eee 4 2 Alarm Menu Volume Modes CV V A C SIMV ccc ccc cece cece eee eee eeeeee 4 2 Waveform Menu Pressure Leakage Modes CPAP PSV S PSV ST PCV P A C 4 3 Wav
217. n R Rate Range PIP 20 not adjustable in pressure breath Range 2 52 in volume breath Resolution N A Range PIP 20 not adjustable in pressure breath Range 8 60 in Volume breath Resolution N A Range 0 1 to 3s Resolution 0 1 s Default value AUTO Rise time 300 ms Depends on Max Time Backup R Rise time Puritan Bennett 560 Ventilator Clinician s Manual Specifications B 7 B 8 B 8 Table B 10 Ventilator Range Resolution and Accuracy Continued Ventilator Settings Range Resolution and Accuracy Maximum inspiratory time Range 0 8 to 3 s Max time Resolution 0 1 s Default value AUTO Min 3 s 30 R Rate Depends on Min Time R Rate Minimum Fraction of Inspired Oxygen Range 18 to 90 Min FiO gt Resolution 1 Default value 18 Depends on Max FiO Maximum Fraction of Inspired Oxygen Range 30 to 100 Max FiO Resolution 1 Default value 100 Depends on Min FiO Environmental The following environmental conditions shall be observed Table B 11 Environmental Conditions for Storage or Transport Temperature Humidity 40 C to Atmospheric 70 C 40 F to 158 F pressure 40 C to 70 C 40 F to 10 to 95 RH 500 hPa to 1060 hPa 152 m to 3964 m 158 F 7 2 psi to 15 4 psi 500ft to 13 000 ft Table B 12 Environmental Conditions for Operation Temperature Humidity Atmospheric pressure 5 C to 40 C 41 F to10 10 to 95 R
218. n Bennett 560 Ventilator Clinician s Manual 4 2 Bargraph Display Table 4 1 Displayed Monitored Parameters Continued Ratio of inspiratory time measured to exhalation I E Ratio LE 1 9 9 to 9 9 1 fieaeineacniadk The displayed value is updated at each inspiration Flow delivered by the ventilator to the patient at Inspiratory Tidal Volume VTI 0 to 9999 ml aac e cha is measured by the inspiratory transducer and that measurement is used to calculate volume the flow transducers do not directly measure volume The displayed value is updated at each inspiration Currently when a Pressure Controlled or Pressure Support breath is delivered in valve ventilation and a leak is present the ventilator will increase flow to reach the pressure target The monitored VTI in Pressure Controlled or Pressure Support breaths reflects the amount of flow the ventilator delivers from the outlet port during inhalation The monitored value will increase possibly to an abnormally high number when a leak is present This displayed value is not what is delivered to the patient Inspiratory time measured Inspiratory Time Time 0to9 9s ea a j The displayed value only in waveform menu is updated at each exhalation Available only in the single limb patient circuit in Leak Leak 0 to 200 Ipm leak configuration The displayed value only in waveform menu is updated at each inspiration A tient during each breath Mean Airway Pressure MAP 0
219. n parameters ventilation is displayed graphically as follows e Pressure bar chart in the ventilation parameters setting menu e Pressure and flow rate waveforms according to time in the graphic menu if waveforms was selected in the preferences menu Refer to chapter 7 Operating Procedures Note To monitor patient Oxygen levels use an external sensor alarm Digital Monitoring The ventilation parameters monitored or calculated are highlighted in each of the main menus e Ventilation menu Figure 4 1 Figure 4 2 Figure 4 3 e Alarm menu Figure 4 4 Figure 4 5 Figure 4 6 e Waveform menu Figure 4 7 Figure 4 8 Figure 4 9 PB560C18 15 mbar ool OF ii 141009mL EN 3 Leak 0 0 Lpr A3 bpm M ivo 0 0L 4 2 0 M Rate 24 bpm 2 M IE e 1 2 2 OFF oS 241 CPAP PSV S PSV ST PCV P A C a PAC ABS A PB560C19 o PIP 15 mbar o PEEP OF o Rise Time 72 1 o Rate 13 bpm o LE 1 2 0 o l Sens 2 ovtTarget OFF o Preferences Figure 4 2 Ventilation Menu Pressure Valve Configuration Modes PSV S PSV ST PCV P A C Puritan Bennett 560 Ventilator Clinician s Manual 4 1 Monitored Parameters ae PB560C20 H00 mL OFF i 30 mbar B Mc 129m 13bpm mm Rate gt 23bpm 1 2 0 mee 1 2 4 2 M Fio 24 o Sigh OFF i 0 0L O Preferences mar Figure 4 3 Ventilation Menu Volume Mode CV V A C SIMV PB560C21 PIP 30 mbar p000 PEEP 3 mbar Mol 0 0L IE 1 2 4
220. n this configuration the sum of P Support and PEEP must not exceed 55 mbar When Relative Pressure is set to OFF in the Setup Menu P Support allows you to determine inspiratory Absolute pressure 3 2 Puritan Bennett 560 Ventilator Clinician s Manual PSV Mode Parameters and Setting Ranges In this configuration P Support and PEEP are related and their settings must maintain a minimum difference between the two of 2 mbar in leak configuration and 5 mbar in valve configuration PEEP Positive End Expiratory Pressure PEEP allows you to determine the level of pressure maintained during the exhalation phase When Relative Pressure is set to YES in the Setup Menu the sum of P Support and PEEP must not exceed 55 mbar When relative pressure is set to OFF P Support and PEEP are related and their settings must maintain a minimum difference between the two of 2 mbar in leak configuration and 5 mbar in valve configuration The ventilation mode can be adjusted without PEEP PEEP is nearly 0 mbar when set to OFF in valve configuration In leak configuration the minimum PEEP setting is 4 mbar Rise Time This parameter is used during the inspiration phase to determine how the target pressure will be reached This setting indirectly defines the minimum inspiratory time The different levels available are as follows Rise time 200 ms Rise time 21 400 ms Rise time 31 600 ms Rise time 4 800 ms These time ra
221. n valve Setting Min VTE and Max VTE is not mandatory set to OFF but the display of the measured value is always active in double limb configuration Max Rtot Max Alarm Setting TOTAL BREATH RATE The maximum rate threshold set monitors the risk of hyperventilation or ventilator autotriggering Its setting is used to trigger the HIGH RATE alarm Refer to chapter 5 Alarms and Troubleshooting When set the Max Rtot threshold must always exceed the Rate setting by at least 5 bpm If the Rate is readjusted the Max Rtot is automatically readjusted to maintain a minimum difference of 5 bpm Setting the Max Rtot is not mandatory it can be set to OFF the default setting but the measured value is always displayed FIO2 Min and or Max Alarm Settings FRACTION OF INSPIRED OXYGEN An FiO sensor connected to the patient circuit allows you to determine that the correct level of oxygen is being delivered to the patient Min and Max FiO thresholds can be set to trigger LOW FIO2 or HIGH FIO2 alarms Min and Max FiO Max thresholds are related and their settings must maintain a minimum difference of 10 between the two Min and Max FiO settings can be set to OFF if an FiO sensor is not connected Settings are automatically restored once a sensor is reconnected These settings are the same for all ventilation modes 3 22 Puritan Bennett 560 Ventilator Clinician s Manual V SIMV Mode Paramete
222. n valve configuration PEEP POSITIVE END EXPIRATORY PRESSURE PEEP allows you to determine the level of pressure maintained during the exhalation phase Puritan Bennett 560 Ventilator Clinician s Manual V SIMV Mode Parameters and Setting Ranges When Relative Pressure is set to YES in the Setup Menu the sum of P Support and PEEP must not exceed 55 mbar When relative pressure is set to OFF P Support and PEEP are related and their settings must maintain a minimum difference between the two of 2 mbar in leak configuration and 5 mbar in valve configuration The ventilation mode can be adjusted without PEEP PEEP is nearly 0 mbar when set to OFF in valve configuration In leak configuration the minimum PEEP setting is 4 mbar Rate RESPIRATORY RATE Rate is the rate at which ventilator controlled breaths are triggered excluding apnea ventilation Rate and Insp Time are related so that if Rate is greater than 8 bpm then Insp Time must be 0 2 x 60 Rate lt Insp Time lt 0 8 x 60 Rate Note e During apnea ventilation the ventilator delivers controlled breaths according to a backup rate Backup R as long as no inspiratory trigger has been detected e The Backup R value depends on the Rate setting Hence Backup R is at least equal to 8 bpm and becomes equal to the Rate value if Rate is greater than 8 bpm Insp Time INSPIRATORY TIME Insp Time allows you to determine the inspiratory phase duration of ventilato
223. nccaedeut nunca ieee suewheccansetewiesneurs D 1 D 2 Breath Types acne cue nad ep eawneidesauerenueerenbee pecs D 2 D 2 1 Volume Breaths in Assist Control Mode D 2 D 2 2 Pressure Control Breaths in Assist Control Mode D 3 D 2 3 Volume Breaths in V SIMV Mode 006 D 4 D 2 4 Pressure Supported Breaths in SIMV and PSV Modes D 5 D23 CPAP rer eE SEEI EAO D 6 D 3 Ventilation Modes and Apnea 0c cece eee eee D 6 Operational Verification Checklist cccescccccceces E 1 Alarma TESIS cic encase ies aemessanene nen beer iene ee eeuneeen F 1 F 1 Low Pressure Test 0 cece cece ccc cece eee eeeeeeeees F 1 PZ Apnea lest noses antgevesaeaiywe nes ieee nadeaeneaseaouens F 1 R3 Power Failure Test 2c satcaxicicucssadesw ats caaseecntohass F 2 F 4 Occlusion ASU oo is aan insnee eduee ketene geese ssanencaeaes F 2 F 5 High Pressure CSUs 05 0sva uve cewses seaedvwitwedkbaawinaes F 3 F 6 Testing the Baltely ec ictncdateawersnboemeionde paawtarecess F 4 F 7 Involuntary Stop Test 4 osntgartucuetasusesag hoseceaoe genes F 4 Unpacking and Preparation cceccccccccccsccceces G 1 Parts and ACCESSOMICS ccc ccc ccc c cece cccsccscscececes H 1 Ce La N E E E E eons ceases l 1 Puritan Bennett 560 Ventilator Clinician s Manual Figures Figure 1 1 Figure 1 2 Figure 1 3 Figure 1 4 Figure 2 1 Figure 2 2 Figure 2 3 Figure 2 4 Figure 2 5 Figure 2 6 Figure 2 7 Figure 3 1 Fig
224. ndards Association This symbol appears on the ventilator s back panel see Table 1 2 item 5 CE Conformity European Signifies compliance with the medical device directive 2007 47 EC This symbol appears on the ventilator s back panel see Table 1 2 item 5 This symbol appears on the ventilator s front panel UP UNFREEZE key see Figure 2 3 on page 2 6 item 4 This key is used to move the LCD display s cursor upwards line by line increase the value of displayed and selected parameter settings restart unfreeze waveforms tracing This symbol appears on the ventilator s front panel DOWN FREEZE key see Figure 2 3 on page 2 6 item 6 This key is used to move the LCD display s cursor downwards line by line decrease the value of displayed and selected parameter settings stop freeze waveforms tracing This symbol appears on the ventilator s front panel ENTER key see Figure 2 3 on page 2 6 item 5 This key is used to confirm command actions Puritan Bennett 560 Ventilator Clinician s Manual Symbols and Markings Table 1 1 Ventilator Symbols This symbol appears on the ventilator s front panel ALARM CONTROL key see Figure 2 3 on page 2 6 item 3 This key is used to cancel the audible portion of alarms for 60 seconds at a time cancel an alarm For more information refer to section F Alarms Tests This symbol appears on the ventilator s front panel MENU key see Figure 2 3 on page
225. ness of the air inlet filter located on the rear of the ventilator If necessary replace the filter before the recommended replacement period is over see chapter 10 Routine Maintenance This is particularly important when the ventilator is installed on a wheelchair because environmental conditions may cause the filter to become dirty more rapidly For environmental protection the ventilator and its components whatever their respective conditions of operation cannot be disposed of with household waste and must be submitted for suitable selective collection and possible recycling Observe all applicable regulations when disposing of the ventilator and any of its components If the device is damaged its external housing is not correctly closed or it behaves in a way that is not described in this manual excessive noise heat emission unusual odour alarms not triggered during the start up procedure the oxygen and power supplies should be disconnected and use of the device stopped immediately Before using the ventilator s internal battery ensure that the battery is fully charged and that the charge holds Back up ventilators or those in storage should be connected to an AC power source to protect the integrity of the battery The maximum recommended shelf life of the internal battery is two 2 years Do not use a battery that has been stored for two years prior to its first use Periodic recharging is important to help maximize use
226. nformation refer to section 6 4 Patient Circuit on page 6 6 A N WARNING Users must always possess an additional breathing circuit and exhalation valve while using the Puritan Bennett 560 Ventilator Puritan Bennett 560 Ventilator Clinician s Manual 2 4 Device Classification The ventilator s IEC EN 60601 1classification is as follows Protection Insulation class electric shock Class Il Protection index of enclosure IP31 Medical device directive classification Il B Degree of protection against risk of electric shock BF Power External AC mains or DC cigarette lighter or internal DC battery Operation mode Continuous operation For additional information refer to section B Specifications Puritan Bennett 560 Ventilator Clinician s Manual 2 5 Front Panel LCD Display Displays information about the ventilator including patient hours and software version ventilation modes and settings and monitored and calculated patient data and waveforms The display also allows the user to view and using the Control Panel adjust the ventilator s operating and alarm configuration settings Control Panel Features the controls for setting up and operating the ventilator and LEDs to indicate the ventilator s power source ventilation On Off status and alarm priority level Control functions include turning on and off the ventilation configuring ventilation modes silenc
227. ng with a leak configuration circuit it is the average parasitic leak during each cycle and over the past 24 hour period When ventilating with a single limb circuit there is no average leak Al Apnea Index The Apnea index is average number of apnea events per hour of ventilation It is based on the Apnea Alarm Apnea Ti Apnea Time Accumulated apnea time over the previous 24 hour period Spont Cyc Spontaneous Cycling This is the percentage of ventilation cycles initiated by the patient and the ventilator over the previous 24 hour period Machine Total time in hours that the ventilator has been switched on since manufacture Patient Total time in hours and minutes that the current patient has been ventilated Ventilation Report Puritan Bennett 560 Ventilator Clinician s Manual 4 9 Monitored Parameters This page intentionally blank Puritan Bennett 560 Ventilator Clinician s Manual Alarms and Troubleshooting 5 Alarms and Troubleshooting 5 1 5 1 uN WARNING Setting Alarm limits to extreme values can cause the ventilator alarms to malfunction When an alarm condition is triggered or there is evidence of a patient ventilator fault or problem examine the patient first before examining the ventilator The alarms or faults generated by your Puritan Bennett 560 Ventilator are classified into two categories e Ventilation or utilisation alarms e Technical faults Some of the ventilator alarm
228. nges are determined by the pressure setting required the breath rate and the physiological condition of the patient Sens Inspiratory Trigger Sensitivity Sens allows you to set the level of inspiratory effort the patient has to provide during the initiation of a machine breath The sensitivity levels decrease from 1P to 5 the lower the number the more sensitive the trigger sensitivity These levels correspond to differences in flow compared to the bias flow Sens 1 P Bias flow 0 4 lpm to 1 lpm P Pediatric use Sens 2 Bias flow 0 7 lpm to 1 3 lpm Sens 3 Bias flow 0 9 lpm to 1 5 lpm Sens 4 Bias flow 1 0 lpm to 1 6 lpm Sens 5 Bias flow 1 2 lpm to 1 8 lpm The bias flow consists of turbine flow through the patient circuit during the exhalation phase that helps the patient avoid rebreathing exhaled gas CO3 The inspiratory trigger is initiated after a time delay of between 700 ms to 1500 ms depending on the preceding peak inspiratory flow A N WARNING Ensure that the I Sens setting is not set to OFF when ventilating patients capable of triggering spontaneous breaths Carefully modify the trigger threshold setting to reduce the risk of ventilator autotriggering Level 1P the most sensitive inspiratory trigger is recommended for pediatric use For an adult this setting may result in ventilator autotriggering Puritan Bennett 560 Ventilator Clinician s Manual 3 3 Op
229. ning the International Carriage of Dangerous Goods by Road ADR for Europe Private individuals who transport the device are excluded from these regulations although for air transport some requirements apply For air transport the Puritan Bennett 560 Ventilator is permitted as checked in or carry on baggage Two spare batteries per person may be taken on board as carry on luggage only with the prior approval of the airline This classification and regulatory requirements may vary depending upon the country and mode of transport Therefore it is recommended that users verify with the carrier airline as to which measures to take before the voyage To minimise the risk of damage you must use the ventilator s Dual Bag to transport the ventilator See Table H 1 List of Consumables and Accessories Regularly clean the ventilator s Dual Bag according to manufacturer s recommendations The ventilator should never be immersed in any liquid and any liquid on the surface of the device should be wiped away immediately Puritan Bennett 560 Ventilator Clinician s Manual Warnings e To avoid damage to the ventilator in particular the batteries or electrical components fluids must not be allowed to enter the device particularly through the air inlet filter or the cooling apertures located in the side rear and bottom panels of the ventilator e To ensure correct and lasting operation of the device ensure that the ventilator is installe
230. not to allow excess moisture to enter any of the openings on the ventilator s surface See the warning above 4 Dry the ventilator surface with a clean soft lint free cloth Table 9 1 Approved Cleaning Solutions for Exterior Ventilator Surfaces Description Mild dishwashing detergent 70 isopropyl alcohol rubbing alcohol 10 chlorine bleach 90 tap water Puritan Bennett 560 Ventilator Clinician s Manual 9 1 Cleaning 9 2 9 3 A Table 9 1 Approved Cleaning Solutions for Exterior Ventilator Surfaces Continued Description Glutaraldehyde Hospital disinfectant cleaners Hydrogen peroxide 15 ammonia 85 tap water Ammonia based household cleaners Household cleaners Cleaning the Accessories Follow the accessory manufacturer s instructions for cleaning the ventilator s accessories and components including the patient circuit WARNING After assembling cleaning or reassembling the patient circuit and on a daily basis inspect the hoses and other components to ensure that there are no cracks or leaks and that all connections are secure Never use a liquid cleaner inside the patient circuit or on any component of a gas pathway Clean the patient circuit only as specified by the manufacturer s instructions Cleaning the Exhalation Block WARNING The exhalation block is intended for single use by a single patient D It may periodically be cleaned but it cannot be disinfected or steri
231. ns 25 Refer to the waveforms shown below Airway Start of Inspiration End of Inspiration Pressure Flow Ventilation Modes and Apnea In SIMV mode with apnea time Apnea Time settings the ventilator will sound an APNEA alarm if no patient effort occurs during the apnea time During an APNEA alarm the ventilator delivers breaths at a breath rate backup rate equal to the maximum of eight 8 and the breath rate setting R Rate If the patient initiates a spontaneous breath the ventilator will stop the controlled breaths and return to the previous operating parameters In PSV mode the back up rate is activated so that the ventilator will automatically begin to deliver breaths at the breath rate Backup R setting if no patient effort occurs for the Apnea Time setting The pressure during a back up breath is equal to the Pressure Support P Support setting before the apnea condition began If the patient initiates a spontaneous breath while the back up rate is in effect the ventilator will return to the previous operating parameters In CPAP a backup rate is not set but the operator must still set an apnea time Apnea Time In that case the ventilator will sound an APNEA alarm if no breath is triggered by the patient in the apnea time however no back up breaths will be generated Puritan Bennett 560 Ventilator Clinician s Manual E Operational Verification Checklist The operational verification and safety checks lis
232. ntilator to an external DC power source Powering the ventilator using an external 12 30 VDC power source via the DC power cable does not enable its internal battery to recharge Due to its limited internal battery s reserve capacity the ventilator should only be operated on the internal battery when no other power source is available Ensure that the internal battery never becomes fully discharged When using a car auxiliary adapter cigarette lighter ensure the car has been started prior to plugging in the ventilator s DC adapter Refer to chapter 6 3 Connecting to an External DC Power Source Even if the INTERNAL BATTERY charging indicator is off charging of the battery may sometimes be incomplete if the ambient temperature is above 40 C 104 F because of the battery s internal heat safety device When the LOW BATTERY alarm is triggered immediately connect the ventilator to an AC power supply to maintain ventilation and recharge the internal battery Batteries should be disposed of according to environmental legislation in your country and locality Never expose any batteries to direct flame Ensure that the AC power cable is in perfect condition and not compressed The device should not be turned on if the AC power cable is damaged AN Warnings Regarding Hoses and Accessories The ventilator must not use nor be connected to any anti static or electrically conductive hoses tubing or conduits Mini
233. o circumstances should the oxygen hose be modified by the user In addition the hose must be installed without the use of lubricants A connector Figure 6 15 item 1 for an external low pressure oxygen source is available at the rear of the ventilator It is essential that you also use the special coupler item 2 supplied with the ventilator to attach the external low pressure oxygen source to the connector The connector is also fitted with a non return airtight valve system The non return airtight valve system includes a stud item 3 anda locking tab item 4 Puritan Bennett 560 Ventilator Clinician s Manual Oxygen pa Figure 6 15 Rear Panel Oxygen Connector A N WARNING Before connecting the oxygen supply ensure that the stud on the oxygen connector Figure 6 15 item 3 is protruding outwards Inspect the oxygen coupler Figure 6 16 item 2 before use to ensure it has its black O ring attached and in good condition Do not use an oxygen coupler with a missing damaged or worn O ring To connect the oxygen supply system to the ventilator Refer to Figure 6 16 as required 1 Puritan Bennett 560 Ventilator Clinician s Manual Inspect the oxygen supply s connector Figure 6 16 item 1 to ensure that connector s black O ring item 2 is not missing Push the oxygen supply s oxygen connector item 1 into the ventilator s oxygen connector Figure 6 16 item 3 the ventilator
234. of a spontaneous breath The Puritan Bennett 560 Ventilator is flow triggered with sensitivity levels in the range from 1 to 5 the lower the number the more sensitive the trigger Sigh A sigh is an increased volume of gas delivered to the patient at a set rate i e every 50 breaths Spont Cyc Spontaneous Cycling This is the percentage of ventilation cycles initiated by the patient over the previous 24 hour period Spontaneous A ventilation mode that delivers assisted breaths only Soontaneous mode does not provide breaths if the patient does not make an inspiratory effort greater than the sensitivity settings and there is no apnea backup rate Standby The operational mode of the ventilator where it is powered power supply I O button set to the I position but is not ventilating the patient SIMV Synchronised Intermittent Mandatory Ventilation A ventilator mode which provides a mechanism for synchronising the ventilator delivered breaths with a patient s inspiration as detected by the ventilator Tidal volume Vt Volume of gas delivered to the patient in a breath Unfreeze Resumption of the waveform plot tracing on the ventilator s display V A C Volume Assist Control A ventilator mode which provides machine initiated breaths are delivered at a clinician set volume inspiratory time and rate Vent Time Ventilation Time The ventilation duration data is based on the patient counter and shows the total
235. of these cycles is identical to the ventilation cycle previously set The controlled cycles following apnea are interrupted as soon as a new spontaneous inspiration of the patient is detected The Backup R is linked to the Min I Time so that the Min Time setting cannot be greater than half the inspiratory phase of a ventilator controlled breath Backup R breath is delivered at the Pressure Support settings Setting a Backup Rate is not optional it is always set Apnea Time Apnea time allows the user to monitor and detect interruptions to the patient s spontaneous breathing pattern The ventilator declares apnea when no breath has been delivered by the time that the operator selected apnea interval elapses Puritan Bennett 560 Ventilator Clinician s Manual PSV Mode Parameters and Setting Ranges The APNEA TIME adjustment range shall be 1 to 60 seconds The ventilator shall enable the operator to set an auto setting which shall automatically calculate the APNEA TIME according to the following APNEA TIME 60 BACKUP R for PSV ST mode or 12 s for V SIMV and P SIMV modes The Apnea Time AUTO setting in seconds is calculated using the formula Auto Maximum value between 3 seconds and 60 Backup R or AUTO 30 in CPAP mode Note During apnea ventilation the ventilator delivers machine controlled breaths according to a backup rate Backup R as long as no inspiratory trigger has been detected The Backup R value app
236. oing one of the following set a Max VTI alarm limit for pressure modes or a Min VTE alarm limit for all ventilation modes if using a dual limb circuit As a reminder Ensure that the length and the internal volume of the patient circuit are compatible with the tidal volume ringed tube 22 mm for adults and ringed tube 15 mm for pediatric patients with tidal volumes lower than 200 ml Use if necessary a 22F 15M link on the outlet and a 15M 22M link on the exhalation block for a double limb circuit WARNING When using non invasive ventilation NIV without an exhalation valve use a vented nose or face mask or a non vented combined with a leak accessory When using non invasive ventilation NIV with an exhalation valve use a non vented mask The level of inspiratory resistance of the circuit and accessories bacteria filter humidifier and so on must be as low as possible Settings particularly the PATIENT DISCONNECTION alarm High inspired volume High VTI and Low inspired volume Low VTI settings must be periodically adjusted according to changes in the patient circuit resistance especially when filters are replaced Resistance of the exhalation valve and accessories water traps filters HMEs etc must be as low as possible The exhalation valve must allow rapid discharge of the circuit pressure Ensure that the exhalation valve is always clean and its evacuation aperture exhaust port is never obstructed Do not sta
237. on Flow Sensor on page 10 1 Call your customer service representative Exhalation block missing or disconnected Set the Min VTE alarm limit to OFF LOW VTE Adjustment of a Min VTE threshold when the patient circuit is in a single limb A WARNING configuration If exhaled tidal volume monitoring is required use the double limb circuit Replace the patient circuit with an Inappropriate patient circuit appropriate one Calibrate the exhalation flow sensor refer to section 10 1 Calibrating the Exhalation Flow Sensor on page 10 1 Exhalation flow sensor not properly calibrated Replace the defective component s and calibrate the exhalation flow sensor see Defective exhalation flow sensor section 10 1 Calibrating the Exhalation Flow Sensor on page 10 1 Call your customer service representative Adjustment of the Min VTE level too high Modify the Min VTE level Adjustment of the Min VTI level too high for PSV CPAP P A C P SIMV and V SIMV Modify the Min VTI level modes Adjustment of the pressure level not enough to reach the volume required for Modify the pressure level according to the PSV CPAP PA C P SIMV and V SIMV physician s prescription modes Patient circuit obstructed or disconnected Clean unblock and or reconnect the patient circuit Inappropriate patient circuit Replace the patient circuit Check patient replace the device and call your technician or customer service
238. on of the rate setting and the Insp Time setting e Rise Time is always possible e Rise Time is established only if Insp Time 0 7 seconds e Rise Time is established only if Insp Time 0 9 seconds e Rise Time is established only if Insp Time 1 1 seconds Note Insp Time is not a setting and is displayed as Ti when the I E or I T ratio is adjusted Rate RESPIRATORY RATE Rate allows you to define the minimal frequency of mandatory ventilator breaths If the patient actuates the inspiration trigger Total Rate may increase Note Insp Time is not a setting and is displayed as Ti when the I E or I T ratio is adjusted I E I T Cycling rate E allows you to determine the ratio between the inspiratory breath phase duration and the exhalation breath phase duration Puritan Bennett 560 Ventilator Clinician s Manual 3 11 Operating Parameters I T allows you to determine the ratio between the inspiratory breath phase duration and the total breath duration inhalation exhalation Note Insp Time is not a setting and is displayed as Ti when the I E or I T ratio is adjusted I Sens INSPIRATORY TRIGGER SENSITIVITY Sens allows you to set the level of inspiratory effort the patient has to provide to initiate a machine breath The sensitivity levels decrease from 1P to 5 the lower the number the more sensitive the trigger sensitivity These levels correspond to differences in flow compared to the bias flow Sens
239. on on the FIO2 CALIBRATION FAIL alarm Refer to chapter 5 8 Troubleshooting 10 3 Replacing the Air Inlet Filter J N WARNING Regularly check the cleanliness of the air inlet filter located on the rear of the ventilator If necessary replace the filter before the recommended replacement period is over This is particularly important when the ventilator is installed on a wheelchair because environmental conditions may cause the filter to become dirty more rapidly Failing to replace a dirty air inlet filter or operating the ventilator without a filter may cause serious damage to the ventilator The air inlet filter is not reusable do not attempt to wash clean or reuse it If the ventilator is used indoors the condition of the air inlet filter should be checked monthly If the ventilator is used outdoors or in a dusty environment the air inlet filter should be checked weekly and replaced as necessary To replace the air inlet filter 1 Hold the filter between your fingers see Figure 10 9 item 1 2 Remove the filter Figure 10 9 item 2 and discard it Puritan Bennett 560 Ventilator Clinician s Manual 10 5 Routine Maintenance 3 Place the new filter in the device while ensuring that a The fine particle side of the filter faces outwards away from the ventilator b The filter is properly installed in its housing Proper installation of the filter prevents particles from entering the device Figu
240. on time Te ratio I E 1 Te Ti In P A C and V A C modes the cycling ratio changes based on patient inspiration however the inspiratory time remains constant and corresponds to the rate and cycling ratio settings Note When adjusting I E or I T ratio the corresponding calculated Ti is displayed below the parameter zoom in the monitoring and information window Absolute and Relative Pressure The relative pressure for the inspiratory pressure setting P Control and P Support in PSV P A C and P SIMV can be set to OFF or YES and allows the choice between setting the inspiratory pressure relative to PEEP or setting an absolute inspiratory pressure The default value is absolute ABS If relative pressure is set to YES the PEEP is added to the inspiratory pressure setting to determine the peak inspiratory pressure If relative pressure is set to OFF the inspiratory pressure setting will determine the peak inspiratory pressure regardless of the PEEP setting Relative pressure YES Inspiratory pressure setting PEEP Peak Inspiratory pressure Puritan Bennett 560 Ventilator Clinician s Manual 7 5 Operating Procedures Relative pressure OFF ABS Inspiratory pressure setting Peak Inspiratory pressure The symbol ABS for absolute or REL for relative will be displayed at the top of the screen as follows PB560C02 PB560C02A o PC p gt ABS z o PC m F Control 3 mbar an m FP Control 30 mbar i o PEEP 10 mbar D M
241. onment as follows e Temperature approximately 21 C 70 F e Humidity less than 80 RH Note When the device is in storage it should be recharged monthly to maximise battery life If the battery is stored for more than one month at a temperature greater than 21 C 70 F or for more than one or two weeks at a temperature greater than 45 C 113 F the reserve capacity of the battery may be affected It will then be necessary to recharge the battery before using it again If the ventilator has been in storage for longer than 30 days connect it to an AC power source turn on the unit by the I O switch at the rear of the ventilator and let it charge for 15 minutes prior to starting ventilation Note Fully charge the internal battery prior to disconnecting from AC Power source mains The battery should not be stored for more than two years whatever the conditions Puritan Bennett 560 Ventilator Clinician s Manual 8 5 This page intentionally blank Cleaning the Ventilator 9 Cleaning 9 1 AN WARNING A patient treated by mechanical ventilation is highly vulnerable to the risks of infection Dirty or contaminated equipment is a potential source of infection Clean the ventilator and its accessories regularly and systematically before and after each use and following any maintenance procedure to reduce the risks of infection The use of a bacterial filter at the ventilator s outlet or both ports if a
242. or 1 cece eee cece nent eee eeeenee 10 2 Figure 10 3 Calibrating the Exhalation Flow Sensor 2 ccc cece cece ee ee eee eeeeeee 10 2 Figure 10 4 Calibrating the Exhalation Flow Sensor 3 ccc cece cece eee e eee eeeeeeee 10 2 Figure 10 5 Calibrating the FiO2 sensor 1 cece ccc cece cence eee eee eeeeeeeeeeees 10 3 Figure 10 6 Calibrating the FiO2 Sensor 2 s2206 lt scacsesseudetecavevacesucdened ess siaaeeawen 10 4 Figure 10 7 Calibrating the FiO2 Sensor 3 i e lt 4 ee esessseeesieeaneeeceedbaeas ie edewadeeeees 10 4 Figure 10 8 Calibrating the FiO2 Sensor 4 ccc cece cece cee eee n eee e ee eeeeeenes 10 5 Figure 10 9 Replacing the Air Inlet filter 0 ccc cee eect e een n seen eeeees 10 6 FIGUIe CL Gas Deliver System 2200244 d2tcceasvewcndaceun sea edap ER EE Daraa Ei C 2 Figure F 1 Blocking the Patient End of a Single Limb Circuit 0 0c ccc cece ence eens F 3 Figure G 1 Puritan Bennett 560 Ventilator 0 0 ccc ccc ccc cece cence eee e eee eeenees G 2 FIOUKE G2 Dual BAG ic0n cars ereire E r EEEE ESEESE EIEE pedatetedaue eked aes enweenenenened G 2 Puritan Bennett 560 Ventilator Clinician s Manual vii This page intentionally blank viii Puritan Bennett 560 Ventilator Clinician s Manual Tables Table 1 1 Table 1 2 Table 3 1 Table 3 2 Table 3 3 Table 3 4 Table 3 5 Table 3 6 Table 3 7 Table 3 8 Table 3 9 Table 3
243. or a breathing pattern capable of supporting an individual s respiratory needs Al Apnea Index The Apnea index is average number of apnea events per hour of ventilation It is based on the Apnea Alarm Apnea Time Time allowed between breath starts before APNEA alarm occurs when no patient effort is detected Assist Control In Assist Control mode the ventilator delivers an assisted breath of a set volume or set pressure when the patient s breathing effort creates a flow or pressure drop that is greater than the SENSITIVITY setting In absence of patient breathing effort the ventilator will deliver a controlled breath of the set volume or pressure Does not apply in PSV CPAP mode Assisted Breath A volume or pressure breath triggered by the patient but then controlled and terminated by the ventilator Audio Pause Pauses the audible alarm for 60 seconds at a time and shows the x symbol often referred to as Alarm Silence Back Up Rate Rate of control cycles in PSV or SIMV modes during apnea phase Battery Level Display of the remaining battery capacity located adjacent to the battery symbol Puritan Bennett 560 Ventilator Clinician s Manual l 1 Glossary Bias flow Turbine flow during exhalation phase through the patient circuit to avoid rebreathing bpm An abbreviation for breaths per minute which is the unit of measure for breath rate see below Breath Rate Back Up R The total number of bre
244. or controlled and perform according to specific control algorithms The microprocessor control circuit receives its data from the various servo controlled pressure and feedback flow sensors that11 are built into the ventilator An electrical supply management system performs the energy conversions necessary for operation and switching between the available power sources and the regulated load of the internal battery A cooling fan helps maintain the proper operating temperature range for the internal environment of the ventilator This fan is servo controlled to maintain the proper temperature for the most heat sensitive of the ventilator s components Operation The operation of the device is based on a self adapting closed loop drive system The speed of the flow generator turbine is servo controlled according to the patient pressure signal or the inspired flow signal The turbine speed control algorithms themselves are based on equations that vary according to the ventilation modes settings and the respiratory cycle phases Thus fixing the pressure rise time or flow pattern has an influence on the level of turbine acceleration at the start of the inspiration phase The transition between the inspiration phase and expiration phase is controlled by a deceleration or braking algorithm proportional to the pressure difference between the two phases The exhalation solenoid valve three way valve is fully closed during the inspiratory phase
245. or illuminates Figure 8 4 item 1 e The INTERNAL BATTERY indicator flashes Figure 8 4 item 2 Figure 8 4 Power Indicators When Charging the Battery When the battery charge is complete the INTERNAL BATTERY indicator turns off WARNING Even if the INTERNAL BATTERY indicator is off charge of the battery may sometimes be incomplete regardless of charge time when the ambient temperature is above 40 C 104 F This is due to the characteristics of the battery s internal heat safety device Although it is not necessary to start the ventilator to charge the battery charging the battery duringoperation will increase the time required to fully charge the internal battery When recharging a depleted internal battery it may be necessary to leave the ventilator on charge for up to six 6 hours if the ventilator is on standby and about 13 hours if ventilation is operating Puritan Bennett 560 Ventilator Clinician s Manual 8 5 Storage A N WARNING Ensure that the ventilator s internal battery is fully charged before connecting the ventilator to an external DC power source Powering the ventilator using an external 12 30 VDC power source via the DC power cable does not enable charging of its internal battery Storage If the ventilator is to be stored for an extended period of time it is not necessary to remove the battery However the ventilator should be stored in cool dry well ventilated envir
246. or within specified limits and to help ensure proper performance and longevity of the device Finally the various measurement signals used in control and detection are protected and specifically filtered in order to limit any risk of disturbance to the device and possible problem Figure C 1 for an illustration of the ventilator s gas delivery system 560 Ventilator Air filter Not shown with Screen Ph B lt F i022 Port sa humidifier i i H an aai nebulizer nspa tay GA or additional water iter Air Inlet 02 Solenoid Exhalation Valve P ilot tube Low Pressure O Inlet Nurse Call Cable Nurse FOR xO Nurse ap ttlldseccsescecescsesscese h l SpO2 a o jan lt Type A a Port Not Used r a USB Porshe E xpiratory Water Trap Mini F ilter Type B C PERPE PCP 7 ee BETES v B E l J ini Exhalation DC H DELS F t AC ENA Lh x Input ort Exhaust Port p Power E pwr Mgt PCB VEN_10115_C Figure C 1 Gas Delivery System Puritan Bennett 560 Ventilator Clinician s Manual Modes of Ventilation D Modes and Breath Types D 1 Modes of Ventilation This chapter is a general description of the various modes of ventilation and breath types available with the Puritan Bennett 560 Ventilator Note The default ventilation mode setting is P A C for more information see below D 1 1 Assist Control A C Modes When
247. ow 0 4 lpm to 1 lpm P Pediatric use Sens 2 Bias flow 0 7 lpm to 1 3 lpm Sens 3 Bias flow 0 9 lpm to 1 5 lpm Sens 4 Bias flow 1 0 lpm to 1 6 lpm Sens 5 Bias flow 1 2 lpm to 1 8 lpm The bias flow consists of turbine flow through the patient circuit during the exhalation phase that helps the patient avoid rebreathing exhaled gas CO3 The inspiratory trigger is initiated after a time delay of between 700 ms to 1500 ms depending on the preceding peak inspiratory flow Sens can be set to OFF WARNING The inspiration trigger threshold should be carefully modified in order to avoid the risk of false triggering or autotriggering of the ventilator For example Level 1P the most sensitive mode is recommended for pediatric use However for an adult this setting may result in autotriggering Sigh VT A sigh is an increased volume of gas delivered to the patient at a set rate i e every 50 breaths The Vt multiplied by Sigh Vt gives the amount of volume delivered to the patient during a Sigh Sigh Rate Sigh Rate is the frequency with which Sigh breaths are delivered PIP Min and Max Alarm Settings PEAK INSPIRATORY PRESSURE A minimum and maximum inspiratory pressure alarm threshold must be set The Min PIP or Low Pressure setting determines the trigger threshold for the PATIENT DISCONNECTION alarm Refer to chapter 5 Alarms and Troubleshooting If this pressure l
248. pressure and flow waveforms while continuing patient ventilation 4 6 Puritan Bennett 560 Ventilator Clinician s Manual Ventilation Report To freeze the waveform trace Press the DOWN 6 v key e The waveform display is frozen e The display of the last numerical monitored values remains fixed e The Freeze Waveform il symbol is displayed in the upper part of the screen To unfreeze the waveform trace Press the UP a key e Waveform tracing continues e The display of the numerical values monitored is refreshed e The Freeze Waveform il symbol disappears The Freeze Waveform function remains active even when changing the ventilation or alarm menu or stopping ventilation Accessing the Preferences Menu or the Alarm logs screen while the Freeze Waveform function is active deactivates this function To dismiss the waveform screen manually Press the MENU key The waveform screen is automatically dismissed e When a High priority alarm is triggered e When you press the VENTILATION ON OFF key to stop ventilation 4 4 Ventilation Report The Ventilation Report is available in the Preferences Menu refer to chapter 7 Operating Procedures The Ventilation Report updates daily at 8am and shows the average readings from the previous 24 hours Refer to Figure 4 15 VENTILATION REPORT PB560C33 Vent Time E n min on 27 APR 2007 tl t Machine OOO0d2h Patient 00009h445min m Hack Figure 4
249. pressure cycles as have been triggered by the patient beyond the period the following inspiration trigger will initiate a new volume cycle and so forth Refer to the waveforms on the following page Puritan Bennett 560 Ventilator Clinician s Manual Breath Types Airway Pressure Flow D 2 4 Pressure Supported Breaths in SIMV and PSV Modes In P SIMV or Synchronised and PSV modes the supported breaths maintain the selected pressure P Support Inspiration is triggered by patient generated flow The inspiration is terminated when inspiratory flow drops to the Exhalation Sensitivity E Sens setting In P SIMV additional mandatory pressure breaths will be delivered dependent on the selected Breath Rate Rate The shape of the pressure waveform depends on the setting of the pressure rise time Rise Time Refer to the waveforms shown below End of Inspiration End of Inspiration Airway l Airway Pressure Pressure Time Flow 50 Time Puritan Bennett 560 Ventilator Clinician s Manual D 5 Modes and Breath Types D 3 D 6 D 2 5 CPAP In Continuous Positive Airway Pressure CPAP the ventilator maintains pressure at the selected PEEP over the entire breath cycle Inspiration is triggered by patient generated flow Inspiration is limited by the pressure and is cycled by the patient when inspiratory flow drops to the Exhalation Sensitivity threshold E Se
250. r controlled breaths For physiological and efficiency reasons its setting is limited by those of Vt and Rate The ratio Vt Insp Time must be between 3 litres and 100 litres 3 lt Vt x 60 InspTime x 1000 lt 100 Note The Backup R value depends on the Rate setting Hence Backup R is at least equal to 8 bpm and becomes equal to the Rate value if Rate is greater than 8 bpm Sens INSPIRATORY TRIGGER SENSITIVITY Sens allows you to set the level of inspiratory effort the patient has to provide during the initiation of a machine breath The sensitivity levels decrease from 1P to 5 the lower the number the more sensitive the trigger sensitivity These levels correspond to differences in flow compared to the bias flow Sens 1 P Bias flow 0 4 lpm to 1 lpm P Pediatric use Sens 2 Bias flow 0 7 lpm to 1 3 lpm Sens 3 Bias flow 0 9 lpm to 1 5 lpm Sens 4 Bias flow 1 0 lpm to 1 6 lpm Sens 5 Bias flow 1 2 lpm to 1 8 lpm The bias flow consists of turbine flow through the patient circuit during the exhalation phase that helps the patient avoid rebreathing exhaled gas CO The inspiratory trigger is initiated after a time delay of between 700 ms to 1500 ms depending on the preceding peak inspiratory flow Puritan Bennett 560 Ventilator Clinician s Manual 3 25 Operating Parameters 3 26 AN WARNING The inspiration trigger threshold should be carefully modified
251. rd keep matches lighted cigarettes and all other sources of ignition such as flammable anesthetics and or heaters away from the ventilator and oxygen hoses Never connect your ventilator to an electrical outlet controlled by a wall switch because the power may be inadvertently turned off Puritan Bennett 560 Ventilator Clinician s Manual 6 1 Installation and Assembly 6 2 6 2 Even if the INTERNAL BATTERY charging indicator is off charging of the battery may sometimes be incomplete if the ambient temperature is above 40 C 104 F because of the battery s internal heat safety device The use of any accessory other than those specified with the exception of the power supplies or cables sold by Covidien may lead to an increase in electromagnetic emissions or a decrease in the equipment protection against electromagnetic emissions If the ventilator is used adjacent to such accessories or stacked with such devices the ventilator s performance should be monitored to verify normal operation The Puritan Bennett 560 Ventilator requires special precautions for electromagnetic compatibility and should be installed and started according to the recommendations found in Appendix B Specifications In particular the use of nearby mobile and portable communications equipment using radio frequencies such as mobile telephones or other systems exceeding the levels set in the IEC EN 60601 1 2 standard may affect its oper
252. re 10 9 Replacing the Air Inlet filter 10 4 Recommended Schedule of Maintenance 10 6 Consumables and Replacement Intervals When used under normal circumstances a relatively dust free atmosphere and without damage to the device and its components shocks cracks significant dirt the intervals for replacing the ventilator s consumable elements are as follows Table 10 1 Consumables and Replacement Intervals Elements o Recommended Replacement Intervals Air Inlet Filter Once a month or more often depending on Foam Fine Particle the extent of soiling Inspirited Bacteria Filter See manufacturer s recommendation See manufacturer s soatent Patient Circuit Single use Single patient Q 14 to 18 months or more often in case of persistent calibration failure Exhalation Block 4 months and for each new patient Note For a list of parts and accessories refer to Appendix H Parts and Accessories or contact your service representative or consult www puritanbennett com The exhalation block replacement frequency may be 3 months for patients ventilated by tracheotomy gt 12 hours day The replacement frequency may be extended to 6 months for patients ventilated lt 12hours day depending on the frequency of technician visits This minimum replacement period is based on bench test validation performed under 24 24 continuous ventilation and active humidification conditions over a period of 3 mon
253. re 5 6 PB560C40 sPA C ABS o PIP 15 mbar o PEEP OFF o Rise Time 2 z D o Rate 13bpm Ka o LE 1 2 0 Se o Sens ovtTarget OFF me VENTILATION TO START Hk mbar o Preferences Figure 5 6 Manually Pausing Alarms When no other alarms are currently activated the last alarm cancelled is displayed continuously in the alarm message window in the Alarms menu along with the date and time of its activation The High Pressure alarm must be manually reset Refer to section 5 7 Overview of Alarms on page 5 7 To manually reset the High Pressure Alarm proceed as follows Press the ALARM CONTROL key twice e The visual alarms will be reset Re activating Alarms Alarms that have been paused and whose activation conditions continue to exist can be reactivated To reactivate alarms proceed as follows 1 Press the MENU CEH key to access the Alarm Setting menu if this is not the menu currently displayed Puritan Bennett 560 Ventilator Clinician s Manual Alarms and Troubleshooting 2 Press the DOWN 6 v key to position the cursor on the Alarm Logs line if this is not already the case Refer to the following graphic o PC P A C a A DAA Ne f X Pan A PB560C39 m Alarms Logs Figure 5 7 Reactivating Alarms 1 Press the ENTER WY key to confirm access to the Alarm Logs menu 2 Press the UP 2a key to position the cursor on the USER S CLEAR ALERT
254. re bar chart 4 1 Principles of operation C 7 Problems 5 25 PROX SENS FLT2 alarm message 5 13 5 24 PSV mode 3 1 PSV Mode Menu Alarm parameters 3 2 R Ramp 3 15 3 26 Range resolution and accuracy specifications B 5 Rate 3 75 3 19 3 25 Rate Respiratory Rate 3 77 Reactivating alarms 5 5 Recharging the internal battery 8 4 REMOVE VALVE CPAP MODE alarm message 5 13 5 24 REMOVE VALVE OR CHANGE PRES alarm message 5 14 5 24 Repairing the ventilator Puritan Bennett 560 Ventilator Clinician s Manual qualified personnel only Warning 10 1 10 5 10 7 Replacement intervals air inlet filter 70 6 air outlet antibacterial filter 70 6 consumables 10 6 exhalation block 10 6 patient circuit 70 6 Replacing air inlet filter 10 5 Resetting alarms 5 5 RESTART 5 70 Rise Time 3 3 3 171 3 21 3 26 Risk of fire warning 6 7 Rtot 3 17 S Safety onboard alarm system 2 2 Service assistance information 10 8 Setting ventilation parameters 7 18 Setup Configuration SETUP menu 7 3 SETUP screen changing parameters 7 4 screen shot 7 3 Sigh Rate 3 16 Sigh VT 3 16 SOFTWARE VERSION ERROR alarm message 5 14 5 25 Specifications electrical B 7 environmental B 8 indicators and alarms B 3 manufacturer s declaration B 9 monitored parameters B 3 performance B 3 physical B 1 pneumatic B 9 range resolution and accuracy B 5 standards compliance and IEC classificat
255. re linked to Vt such that Vt must be greater than Min VTE by at least 10 ml but lower than Max VTE by at least 10 ml If Vt is changed Min VTE and Max VTE are if necessary automatically readjusted so that the difference between them is always maintained VTE is displayed when ventilating with an exhalation valve Setting Min VTE and Max VTE is not mandatory each can be set to OFF but the measured value is always displayed using a double limb patient circuit Max Rtot Max Alarm Setting TOTAL BREATH RATE The maximum rate threshold set is used to monitor and alarm for ventilator autotriggering The alarm setting is used to trigger the HIGH RATE alarm Refer to chapter 5 Alarms and Troubleshooting When set the Max Rtot threshold must always exceed the Backup Rate by 5 bpm the Max Rtot is automatically readjusted to maintain a minimum difference of 5 bpm Setting the Max Rtot is not mandatory it can set to OFF but the measured value is always displayed FIO2 Min and or Max Alarm Settings FRACTION OF INSPIRED OXYGEN An FiO sensor connected to the patient circuit allows you to determine that the correct level of oxygen is being delivered to the patient Min and Max FiO thresholds can be set to trigger LOW FIO2 or HIGH FIO2 alarms Min FiO and Max FiO thresholds are related and their settings must maintain a minimum difference of 10 between the two Min and Max FiO settings can
256. rective Actions Continued ji Message or Possible Reason s For The Alarm Event Corrective Action s ymptom Check that the patient circuit is correctly attached and the patient is correctly ventilated The ventilator is delivering apnea ventilation at set back up rate CONTROLLED CYCLES Restart ventilator to see if alarm clears If COOLING FAN RESTART SRVC DC POWER Operating speed of the cooling fan not properly adjusted for the internal ambient temperature of the device 12 30 VDC power supply cut off when there is no AC mains power supply not replace the ventilator and call your customer service representative Cancel the alarm then check the supply wiring and or the effective availability of voltage on the external source f ini Replace the ventilator and call your Ventilator s current limiting fuse blown j customer service representative DISCONNECTION DEVICE FAULT3 IF PERSISTS RESTART SRVC DEVICE FAULTS IF PERSISTS RESTART SRVC DEVICE FAULT7 IF PERSISTS RESTART SRVC DEVICE FAULT9 IF PERSISTS RESTART SRVC DEVICE FAULT10 IF PERSISTS RESTART SRVC DEVICE FAULT11 IF PERSISTS RESTART SRVC DEVICE FAULT12 IF PERSISTS RESTART SRVC DEVICE FAULT13 IF PERSISTS RESTART SRVC EMPTY BATTERY 24 V supply failure Internal problem in the electrical power supply Internal technical problem POST RAM Error RAM Read Write does not matc
257. rocedures 7 4 2 Changing Modes During Ventilation WARNING When changing the mode during ventilation significant transitions of pressure flow or cycling rate might occur depending on the difference between the modes Before setting the new mode first ensure that the settings between the different modes are compatible This reduces the risk of discomfort and harm to the patient Changing ventilation modes during ventilation 1 Place the cursor on the first line of the menu general information line using the UP a key PB560C68 a PAC ABS o PIP 15 mbar OoPEEP OF meth 87 9mL o Rise Time 72 z Leak 0 0 Lpm o Rate 13bpm _ Mol 0 0L o lE 1 2 0 if Rate 10bpm o l Sens 2 ME E e 1 2 3 ovtTarget OFF y o Preferences Figure 7 16 Changing Ventilation Modes During Ventilation 1 2 Press ENTER GA e The cursor changes to e The mode name flashes Press UP TaD or DOWN D until the required mode is displayed 4 Press ENTER A to confirm the mode selected e The name of the new mode selected is displayed at the top left followed by the flashing INACTIVE status indicator figure below item 1 e The name of the mode in progress is displayed at the top right followed by the continuous ACTIVE status indicator figure below item 2 e The settings for the new mode are displayed on the left figure below item 3 and the monitored values for the mode in progress on the right figure below item
258. rs and Setting Ranges 3 6 VSIMV Mode Parameters and Setting Ranges The menus in the V SIMV Synchronised Intermittent Mandatory Ventilation Volume ventilation mode are shown in Figure 3 10 PB560C16bis PB560C17bis 500 mL OP Support 15 mbar o PEEP OFF 70 4 ePIP mbar D o Rise Time 72 a o Rate A3bpm so VIE m ee eee J TO START TO START o Insp Time 1 5s i i Min Current Max _ VENTILATION o Sens 2 an VENTILATION ORtot bpm i o E Sens 25 3 o Apnea time AUTO o Preferences mbar 5 A 7 o Alarms Lo qs Figure 3 10 Menus in V SIMV Ventilation Mode Table 3 11 shows the adjustments and limits in V SIMV mode Table 3 11 Ventilation Parameters in V SIMV Mode Min Max Adjustment Default Value Value Resolution Value Links 2000 Min VTE Max VTE P Support cmH 0 mbar or hPa PEEP cmH 0O mbar or hPa 7 i Insp Time PEEP Min PIP Max PIP P Support Max PIP Min PIP Vt Max Rtot Insp Time Vt a oe Alarm parameters that are adjustable in the V SIMV mode menu and their adjustment limits are listed in Table 3 12 UI UI O aie N D N MEENE 5 95 Puritan Bennett 560 Ventilator Clinician s Manual 3 23 Operating Parameters 3 24 Table 3 12 Alarm Parameters in the V SIMV Mode Menu Min Max Adjustment Default Value Value Resolution Value Links Min PIP cmH30 mbar PIP or hPa PEEP Lt Max PIP Max PIP cmH 0O mbar PIP or hPa PEEP Min PIP 7 Vt
259. rt is set to off if Inspiratory Pressure is higher than PEEP 10 mbar during three consecutive cycles Alarm activation occurs e After three consecutive breaths Consequence e Switch to exhalation phase Rate measured greater than Max Rtot set during three HIGH RATE consecutive breaths Alarm activation occurs e After three consecutive breaths Expired tidal volume greater HIGH VTE than Max VTE set during three consecutive breaths in double limb setup Alarm activation occurs e After three consecutive breaths Inspired tidal volume greater HIGH VTI than Max VTI set during three consecutive breaths in PSV CPAP PA C P SIMV and V SIMV modes Alarm activation occurs e After three consecutive breaths Inspiratory flow is constant 1 INSP FLOW lpm with normal turbine RESTART SRVC temperature and speed conditions Contact your service representative for assistance Priority condition No clears alarm priority indicator must be manually reset by pressing the X key The visual portion of the alarm may be paused Puritan Bennett 560 Ventilator Clinician s Manual Alarms and Troubleshooting Table 5 1 Overview of Alarms Continued Alarm Message INTENTIONAL VENT STOP KEYPAD FAULT RESTART SRVC IF PERSISTS RESTART SRVC LOW BATTERY LOW FIO2 LOW VTE LOW VTI NO PROXIMAL LINE2 IF PERSISTS RESTART SRVC OCCLUSION CHECK CIRCUIT IF PER
260. rt ventilation until you ensure that the device is suitably assembled that the air inlet filter is properly installed and is not obstructed and that there is proper clearance all around the unit Also ensure that the patient circuit is suitably connected to both the ventilator and the patient and that the patient circuit including all hoses is not damaged or obstructed Adding accessories to the ventilator breathing circuit such as a humidifier and water trap s may result in a decrease in tidal volume delivered to the patient due to the added compressible volume of the accessory Always assure that the patient is receiving the appropriate inspired volume when altering the breathing circuit configuration Filters WARNING Regularly check the cleanliness of the air inlet filter located on the rear of the ventilator If necessary replace the filter before the recommended replacement period is over see chapter 10 Routine Maintenance This is particularly important when the ventilator is installed on a wheelchair because environmental conditions may cause the filter to become dirty more rapidly The ventilator features two filter types e air inlet filter e bacteria filter Puritan Bennett 560 Ventilator Clinician s Manual Filters Air Inlet Filter Consisting of foam and fine particle filter media and located at the rear of the ventilator this filters the air as it enters the ventilator l l a AN
261. rwise the INTERNAL BATTERY indicator illuminates 2 Press the ALARM CONTROL key twice to reset the alarm 3 Reconnect the ventilator to its AC power supply Occlusion Test Note Occlusion testing can only be done in Pressure modes 1 When using a single limb circuit do the following 2 Verify that the pressure tube of the patient circuit is properly connected to the appropriate fitting on both the ventilator and the proximal pressure port refer to section 6 4 Patient Circuit on page 6 6 3 Block the exhalation port on the exhalation valve of the patient circuit Refer to Figure F 1 on page F 3 Puritan Bennett 560 Ventilator Clinician s Manual High Pressure Test 1 l Eaa Wh Pa AI Figure F 1 Blocking the Patient End of a Single Limb Circuit J Press the VENTILATION ON OFF key to start ventilation 5 Allow the ventilator to deliver three 3 consecutive breaths At the beginning of the fourth breath ensure that the following events occur e the High priority indicator red colour illuminates e the Occlusion alarm activates e an audible alarm sounds Press the ALARM CONTROL key to silence the alarm 7 Unblock the exhalation port Di e The alarm is cancelled 8 Press the VENTILATION ON OFF key for three 3 seconds before releasing it e Ventilation stops F 5 High Pressure Test 1 Set the ventilator to V A C mode and set the following parameter values
262. ry when no other power source is available Ensure that the internal battery never becomes fully discharged Do not operate the ventilator in direct sunlight near heat sources outdoors or near installations where liquid may pose a risk without first providing adequate protection for the device To avoid damage to the ventilator in particular the batteries or electrical components fluids must not be allowed to enter the device particularly through the air inlet filter or the cooling apertures located in the side rear and bottom panels of the ventilator If exhaled tidal volume measurements are required to ensure correct patient ventilation a double limb patient circuit configuration must be used in order to detect leaks In this case both the minimum and maximum VTE alarm parameters must be properly set to warn in the event of patient suffocation To minimise the risk of damage you must use the ventilator s Dual Bag to transport the ventilator See Table H 1 List of Consumables and Accessories Before using the ventilator s internal battery ensure that the battery is fully charged and that the charge holds Back up ventilators or those in storage should be connected to an AC power source to protect the integrity of the battery Installation and Assembly The Dual Bag accessory consists of a carrying bag that allows the Puritan Bennett 560 Ventilator to be both mounted onto a wheelchair or carried as a backpack see Figure 6 1
263. s Continued oa messagera Possible Reason s For The Alarm Event Corrective Action s ymptom Excessive moisture in the exhalation block CHECK EXH VALVE Defective connection or defective exhalation valve tubing Defective inspiratory flow sensor The exhalation valve may not be detected by the ventilator when ventilation is started CHECK EXH VALVE PRESSURE Or the exhalation valve may be falsely detected when ventilation is started CHECK FIO2 SENSOR FiO measured is less than 18 Proximal pressure line disconnected or obstructed CHECK PROXIMAL LINE1 IF PERSISTS RESTART SRVC Defective proximal pressure sensor or internal leak of the machine CHECK REMOTE ALARM Relay control voltage problem CHECK SETTINGS with the type of patient circuit used No exhalation valve connected with PEEP CONNECT VALVE set to less than 4 mbar OR CHANGE PRESS or PIP set to more than 30 mbar when relative pressure is set to OFF Obstruction or abnormal damage of the Clean or replace the exhalation valve exhalation valve and or its control tube Remove moisture from exhalation block and valve Verify exhalation valve is seated properly Reduce temperature of the humidifier Reconnect the valve or replace the exhalation valve and or the exhalation valve pilot pressure tube Have a qualified technician replace the defective component s and call your customer service representative Restart ventilator
264. s components for suitable selective collection and possible recycling and observe all applicable regulations Note As the total number of battery charge discharge cycles approaches 300 a drop in potential of as much as 20 may be detected Puritan Bennett 560 Ventilator Clinician s Manual 10 7 Routine Maintenance 10 5 Service Assistance J N WARNING If a problem with the ventilator is suspected FIRST CHECK THAT THE PATIENT IS NOT IN DANGER If necessary remove the patient from the ventilator and provide an alternative means of ventilation Do not attempt to open repair or otherwise service the ventilator yourself Doing so might endanger the patient damage the ventilator and or void your warranty Only qualified service personnel should open repair or service the ventilator In the event of a problem with the ventilator refer to chapter 5 Alarms and Troubleshooting If you cannot determine the cause of the problem contact your equipment supplier or Covidien For more information and local Covidien Technical Service Contact details refer to chapter Technical Support in Preface chapter 10 8 Puritan Bennett 560 Ventilator Clinician s Manual A Patient Caregiver Checklist What the Patient and Caregiver Must Understand Table A 1 presents a summary of the topics that patients and caregivers must understand in order to use the ventilator successfully Some topics may not apply to some patients whi
265. s maintained VTI Min and or Max Alarm Settings INSPIRATORY TIDAL VOLUME It is possible to set a Min and or Max alarm threshold for the inspired tidal volume received by the patient VTI allows you to trigger an alarm during breath delivery if the tidal volume inspired by the patient is lower than the minimum threshold set LOW VTI alarm or greater than the maximum threshold set HIGH VTI alarm Refer to chapter 5 Alarms and Troubleshooting Min VTI and Max VTI are related to Vt such that Vt must be higher than Min VTI by at least 10 ml but lower than Max VTI by at least 10 ml If Vt is changed Min VTI and Max VTI are if necessary automatically readjusted so that the difference between them is maintained Setting Min VTI and Max VTI is not mandatory set to OFF but the display of the measured value is always active in a double limb configuration Puritan Bennett 560 Ventilator Clinician s Manual 3 27 Operating Parameters 3 28 VTE Min and or Max Alarm Settings EXPIRED TIDAL VOLUME A double limb patient circuit configuration must be used when setting the Min and or Max Tidal volume alarm limits These thresholds can be set to trigger an alarm if the Tidal volume expired by the patient is lower than the minimum threshold set LOW VTE alarm or greater than the maximum threshold set HIGH VTE alarm Refer to chapter 5 Alarms and Troubleshooting Min VTE and Max VTE a
266. s are adjustable depending on ventilation modes refer to chapter 3 Operating Parameters Automatic non adjustable alarms also exist to create a safety net for safer patient ventilation Alarms indicate events likely to affect the ventilation in the short term and necessitate rapid intervention refer to section 5 8 Troubleshooting on page 5 15 Technical faults do not directly affect machine operation Therefore the user is not alerted to technical faults Only authorised and trained technicians may consult the maintenance menu refer to the Puritan Bennett 560 Service Manual Note Default alarm setting preferences should be entered prior to using the ventilator Alarm Level of Priority The alarm hierarchy for signalling the level of alarm criticality is listed below e Very High Priority VHP Immediate critical situation ventilation is impossible Continuous Sound Signaling With or Without Continuous Red LED Illumination With or Without Message With or Without Display Lighting it is possible for an alarm condition to occur that may not have both a message and lighting e High Priority HP Critical situation in the short term ventilation is potentially compromised High Speed Intermittent Sound Signaling Flashing Red LED Illumination With Message With Display Lighting e Medium Priority MP Critical situation in the long term ventilation is not affected in the short term Medium Speed In
267. sed for Puritan Bennett Ventilator Test Software 2 On Off I O switch with protective cover 8 O Inlet Port Device powered on in position l device Connects the ventilator to a low pressure oxygen switched off in position 0 source via an adaptor connected to the O Inlet refer to section 6 8 Oxygen on page 6 13 3 AC power Mains cable connector 9 Nurse Call Output Connector Used to connect the ventilator to the nurse call system 4 AC power Mains cable holding system 10 USB Memory Device connection Secures AC power cable to avoid accidental USB connection to be used with Puritan Bennett disconnection respiratory insight software There are two USB type A ports 5 Access cover for the internal battery 11 Air Inlet Filter Filters air as it enters the ventilator 6 DC power cable connector with key Figure 2 2 Back Panel Puritan Bennett 560 Ventilator Clinician s Manual 2 5 2 7 Control Panel E m COVIDIEN Puritan Bennett 560 Ventilator 1 E s r D 7 X 10 ox gt 2 ca 2 E 3 9 8 5 7 6 VEN T0027 _A 1 Alarm indicators two LEDs 6 DOWN FREEZE key Red indicator e Moves the cursor down and decreases parameter values e Continuous Very High Priority VHP alarm e During ventilation freezes displayed waveform in the activated Waveform menu e High priority HP alarm activated Yellow indicator e Medium priority MP alarm activated 2 ALARM CONTROL key 7 MENU key e Press once
268. set to an Assist Control mode machine initiated breaths are delivered at a clinician set volume or pressure inspiratory time and rate If the patient triggers a soontaneous breath between machine breaths the ventilator will deliver a breath based on the volume or pressure settings and inspiratory time Whether initiated by the patient or the ventilator all breaths are delivered at the same preset volume or pressure and inspiratory time The names of the Assist Control modes are e VA C if the breaths are based on a volume setting e PA C if the breaths are based on a pressure setting D 1 2 SIMV Modes When set to a SIMV Synchronised Intermittent Mandatory Ventilation Mode machine initiated breaths are delivered at a clinician set volume or pressure inspiratory time and rate These mandatory breaths are synchronised with patient effort If the patient triggers a spontaneous breath between machine breaths the ventilator will deliver a soontaneous breath which is pressure supported CPAP spontaneous breaths are not available in SIMV modes The names of the SIMV modes are e VSIMV if mandatory breaths are based on a volume setting e PSIMV if mandatory breaths are based on a pressure setting D 1 3 CPAP Mode In CPAP the ventilator maintains a constant level of pressure in the patient s airway D 1 4 PSV Mode PSV mode maintains a constant level of pressure in the patient s airway during exhalation In addition the ventil
269. sfer IWONGS cs os ia 450d coed dar deetonsdeasev eee 7 23 7 7 5 Erase Data from the USB Memory Device 7 25 7 8 Locking the Control Panel cc cece eee eee anes 7 25 7 9 Unlocking the Control Panel ccc cece eee 7 26 7 10 Starting Ventilation nu25 an eoeyediweeetaenerwemieredeeners 7 26 7 11 Stopping Ventilation 2ch4e0 casa satenkeeredamincanenes 7 28 7 12 Turning Off the Ventilator ccc cece eee ee ees 7229 INCEMNal BATLCly 6 cccsovds b5440 00006040eee ustnie r n r are 8 1 8 1 Battery Capacity sa stot asenswe a eetelwrereeesreneeeesases 8 1 8 2 Battery ODealION a 2s4osueesanceaneersgeeeweuneaasseeaen 8 2 8 3 Testing the Battery 0 ccc ccc ccc eee eee e eee ees 8 4 8 4 Recharging the Battery c cece cece cece eee e anes 8 4 8 5 oC 2 E PEPEE ee ere 8 5 CIGANING EEEE E E E EE TETEE 9 1 9 1 Cleaning the Ventilator 0 ccc cece cece cece eee 9 1 9 2 Cleaning the ACCeSSOPI S ccc cece cece eee e ee eeee 9 2 9 3 Cleaning the Exhalation Block 0eeeeeeeee 9 2 Routine Maintenance ccccccccccccccccccccccccece 10 1 10 1 Calibrating the Exhalation Flow Sensor 10 1 10 2 Calibrating the FiO2 sensor cc ccc cc eens 10 3 10 3 Replacing the Air Inlet Filter 0 ccc ccc eee eee 10 5 10 4 Recommended Schedule of Maintenance 10 6 10 5 Service Assistance sesessssesesecseressrosesece
270. splayed instead of OFF f mMin Current Max o Alarms Logs Figure 10 3 Calibrating the Exhalation Flow Sensor 2 8 Press the ENTER WY key to start calibration e The message Exp calib Processing is displayed in the window on the right while calibration is in progress j Min Current Max i Exp calib Processing o Alarms Logs Figure 10 4 Calibrating the Exhalation Flow Sensor 3 e The ventilator adjusts the speed of the blower to reach the initial calibration point 10 2 Puritan Bennett 560 Ventilator Clinician s Manual Calibrating the FiO2 sensor e A short beep sounds to confirm that the first point has been adjusted e The ventilator automatically increases and adjusts the speed of the blower to reach the next calibration point e Ashort beep sounds to confirm that the second calibration point has been adjusted e This process continues until all eight calibration points have been adjusted Note The exhalation flow sensor calibration procedure once initiated must run to its conclusion No message is displayed when the ventilator passes calibration a message only is displayed if the calibration has failed In the event of calibration errors the following events occur e The ventilator sounds along beep at each point that fails calibration e Analarm is activated and the message CALIBRATION FAIL is displayed e The ventilator takes the previously saved valu
271. stopping 7 28 Ventilation modes 2 2 D 1 and apnea D 6 changing during ventilation 7 16 changing while on standby 7 15 vii setting 7 14 VENTILATION ON OFF key 7 2 Ventilation parameters digital monitoring 4 7 modifying 7 18 setting 7 18 setting when linked to alarm thresholds 7 19 setting when linked to other parameters 7 19 V SIMV Mode Menu 3 23 Ventilator architecture of C 7 carrying bag figure G 7 cleaning 9 1 connecting the nurse call cable 6 19 connections proper warning 7 3 6 1 6 6 failure of 2 10 filters 6 70 mounting on a wheelchair 6 17 operation description of C 7 parts and accessories H 7 patient outlet port connections figure 6 9 potentially hot surfaces 7 29 principles of operation C 7 specifications B 1 symbols and markings 7 10 turning off 7 29 turning on 7 7 unpacking and preparation G 7 Ventilator and liquid ingress Warning 7 3 viii Volume alarms 7 11 Vt3 15 3 24 VT Target 3 12 VT Target Target Tidal Volume 3 5 VTE 3 6 3 13 3 17 3 22 3 28 VTI3 6 3 8 3 12 3 21 3 27 VTI NOT REACHED alarm message 5 14 5 25 W Warnings definition of 1 7 general list of 7 7 ventilator dependent patients 3 7 Warranty Preface 1 Waveform menu monitored parameters figure 4 2 Waveform tracing 4 7 Freezing 4 7 unfreezing 4 7 Waveforms display 4 6 7 13 menu 2 9 4 6 Welcome Menu screen display of 7
272. supply connection 6 14 using medical grade only Warning 1 9 6 14 P P A C mode 3 9 P A C Mode Menu Alarm parameters 3 10 P Control 3 19 P SIMV mode 3 18 P SIMV Mode Menu Alarm parameters 3 78 P Support 3 2 3 19 3 24 Parameter values unavailable display 4 4 Parameters alarms setting 7 19 ventilation modifying 7 18 setting of 7 18 Parameters operating Puritan Bennett 560 Ventilator Clinician s Manual CPAP mode 3 7 Apnea Time 3 8 Fraction of Inspired Oxygen FIO2 3 9 Inspiratory Tidal Volume VTI 3 8 Inspiratory Trigger Sensitivity I Sens 3 8 3 9 Max Leak 3 8 Max Rtot 3 8 Positive End Expiratory Pressure PEEP 3 8 P A C mode 3 9 Expired Tidal Volume VTE 3 73 Fraction of Inspired Oxygen FIO2 3 73 LE I T 3 177 Sens Inspiratory Sensitivity 3 12 Inspiratory Tidal Volume VTI 3 12 Max Leak 3 13 Max Rtot 3 73 3 17 3 28 Peak inspiratory pressure PIP 3 70 Positive End Expiratory Pressure PEEP 3 77 Respiratory Rate Rate 3 77 Rise Time 3 11 VT Target Target Tidal Volume 3 72 P A C mode Max P Maximum inspiration pressure 3 12 P SIMV mode 3 18 Apnea Time 3 20 E Sens exhalation sensitivity 3 27 Expired Tidal Volume VTE 3 22 Fraction of Inspired Oxygen FIO2 3 22 Sens Inspiratory Sensitivity 3 20 Time 3 27 Inspiratory Tidal Volume VTI 3 27 Inspiratory Time Insp Time 3 20 Max Rtot 3 22 Posi
273. t of the VENTILATION ON OFF key turns off e The ventilator screen switches off Note When the ventilator is completely stopped but is still connected to the AC power source the green AC POWER indicator is illuminated the internal battery continues charging A continuous alarm condition will be activated if the ventilator power switch is turned off while ventilation is in progress When the power switch is turned back on again the ventilation will resume without having to press the VENTILATION ON OFF button Puritan Bennett 560 Ventilator Clinician s Manual 7 29 Operating Procedures This page intentionally blank 7 30 Puritan Bennett 560 Ventilator Clinician s Manual Battery Capacity 8 Internal Battery WARNING Even though the Puritan Bennett 560 Ventilator meets current safety standards the internal Lithium ion battery of the device exceeds the 100Wh threshold and is therefore considered to be Dangerous Goods DG Class 9 Miscellaneous when transported in commerce As such the Puritan Bennett 560 Ventilator and or the associated Lithium ion battery are subject to strict transport conditions under the Dangerous Goods Regulation for air transport IATA International Air Transport Association International Maritime Dangerous Goods code for sea and the European Agreement concerning the International Carriage of Dangerous Goods by Road ADR for Europe Private individuals who transport the device are ex
274. tection devices and knowledge of the following symbol s meaning ta as well as using original spare parts and respecting quality assurance and traceability rules approved by Covidien Warranty Information regarding your product warranty is available from your sales representative or Covidien Extended Service The Puritan Bennett 560 Ventilator offers extended service contracts warranties for purchase when the ventilator is purchased Please contact your local Covidien Sales or Service Representative for additional information For online technical support visit the SolvITM Center Knowledge Base by clicking the link at O 1 http www puritanbennett com Here you will find answers to frequently asked questions about C E N T E R the product and other Covidien products 24 hours a day 7 days a week If you require further Kn ow ledge b ase assistance contact your local Covidien representative Puritan Bennett 560 Ventilator Clinician s Manual Preface 1 Preface 2 Technical Support Technical Service Contacts Covidien Argentina Aguero 351 Capital Federal 1171 ABC Argentina Tel 5411 4863 5300 Fax 5411 4863 4142 Covidien Belgie S A N V Generaal De Wittelaan 9 5 Mechelen 2800 Belgi Tel 32 152 981 37 Fax 32 152 167 83 Covidien Chile Rosario Norte 530 Piso 12 Las Condes Santiago de Chile Chile Tel 562 231 3411 Fax 562 231 3527 Covidien Czech Republic Vyskoci
275. ted in Table E 1 below should be performed to ensure the ventilator is operating properly in the following circumstances e Prior to using the ventilator with a patient e Monthly while the ventilator is in use e Following maintenance or changes in ventilator settings If the ventilator fails any of the safety checks below or if you cannot complete these checks refer to section 5 8 Troubleshooting on page 5 15 or call the equipment supplier or Covidien refer to section 10 5 Service Assistance on page 10 8 A N WARNING Provide the patient with an alternate means of ventilation before conducting these tests To reduce the risk of infection wash your hands thoroughly before and after handling the ventilator or its accessories Table E 1 Operational Verification Checklist 1 Verify the proper appearance and cleanliness of the ventilator a 2 Verify all of the labels and markings on the ventilator are clear and E legible Confirm the air inlet filter is clean and correctly installed 4 Ensure the AC power cable does not exhibit any signs of damage such as kinks breaks or damaged insulation Connect the AC power cable Ensure that all power supply indicators on the front panel flash except for the AC power supply mains indicator which should remain lit Push the power switch I O to the I position to activate the ventilator test Check that the two alarm indicators and the Standby indicator located close to the
276. termittent Sound Signaling Flashing Yellow LED Illumination With Message With Display Lighting Note There are currently no Low Priority LP Alarms Puritan Bennett 560 Ventilator Clinician s Manual Alarms and Troubleshooting 5 2 5 2 Note If there is no corrective action and if the audible alarm is not inhibited Audio Paused or reset Alarm Reset within 60 seconds High Priority alarms will sound at the maximum level of 85 dB A Alarm Display During operation when an alarm is activated e One of the red or yellow alarm indicators to the left of the ALARM CONTROL key illuminates and flashes e Analarm tone sounds e A message is displayed and flashes in reverse video at the bottom of the Ventilation Menu or Alarm Menu Note a PAC oO PIP o PEEP o Rise Time o Rate OE o I Sens o t Target o Preferences PB560C34 ABS 45 mbar OFF 13 bpm 1 2 0 ee OFF TO START VENTILATION AC POWER DISCONNECT ALARM MENU o PC P A C o Alarms Logs ALARM MESSAGES PB560C35 Figure 5 1 Alarm Displays There are currently no Low Priority LP Alarms When an alarm is triggered if the current menu displayed is not the Ventilation parameters or Alarm menu the display automatically switches to one of these menus to display the alarm message In the event several alarms are activated at the same time the highest priority audible and visual alarm is highlighted
277. ths Test report N O8DE265 Test report results show that no condensation or drops of water that would affect flow measurement were found in the exhalation block or the Piezzo valve Puritan Bennett 560 Ventilator Clinician s Manual Recommended Schedule of Maintenance Note For all additional accessories not necessarily considered as consumables consult the manufacturer s recommendations To prevent any risk of cross contamination we recommend the use of STERIVENT filters Ref 351 5856 or equivalent to protect the patient outlet port and the exhalation block port WARNING Regularly check the cleanliness of the air inlet filter located on the rear of the ventilator Replace it when necessary even before the recommended replacement period has elapsed and particularly when the ventilator is installed on the wheelchair Environmental conditions may cause the filter to become dirty more rapidly The exhalation block is intended for single use by a single patient D It may periodically be cleaned but it cannot be disinfected or sterilised To maintain good measurement quality when used continuously clean the exhalation block periodically refer to section 9 3 Cleaning the Exhalation Block on page 9 2 The exhalation block should be changed every 4 months and cannot be reused with any other patient Failure to observe these recommendations may result in a loss of performance excessive overheating a loss of certain
278. tilation synchronously with inspiratory effort until a preset pressure is met Pressure is maintained throughout patient inspiratory flow and is cycled to expiration by time controlled by the selected Inspiratory Time setting Used in Assist Control mode Pressure Support P Support Augmentation of the patient s ventilation synchronously with inspiratory effort until a preset pressure is met Pressure is maintained until inspiratory flow is reduced to a percentage of peak flow that depends on the exhalation sensitivity setting for the inspiration when the ventilator cycles into exhalation Available in SIMV or Spontaneous modes PSI Pounds Per Square Inch PSV Pressure Support Ventilation Pressure support ventilation Rebreathing The patient breathes his her exhaled gas Respiration rate The number of breath cycles inspiration expiration completed within one minute Normal resting adult respiratory rates are from 12 20 breaths per minute bpm Rise Time This determines how the target pressure will be reached and indirectly defines the minimum inspiration time Puritan Bennett 560 Ventilator Clinician s Manual l 5 Glossary Rtot Parameter measured by the ventilator equal to the total number of breaths per minute bpm Sensitivity This adjustable parameter determines the amount of inspiratory effort required by the patient before the ventilator delivers an assisted breath or demands flow in the case
279. ting should be adjusted for each patient and established in relation to a calibrated oxygen monitor measurement Since the factors that affect administered oxygen flow may change over time you must ensure that these settings always correspond to the current oxygen therapy objectives specified by the physician Refer to chapter 3 7 FiO2 For Various Oxygen and Ventilator Settings WARNING To avoid injury to the patient and or possible damage to the ventilator before using the ventilator use a flow meter flow regulator to regulate the oxygen supply to specifications before connecting the ventilator to the oxygen supply Ensure that the oxygen supply pressure to the machine never exceeds 7 psi 50 kPa or a flow of 15 Ipm Refer to Table B 8 on page B 3 for volume and sensitivity tolerances e The Puritan Bennett 560 Ventilator can be used with an optional oxygen analyser with minimum and maximum concentration alarms Always measure the delivered oxygen with a calibrated oxygen analyser FiO kit that features a minimum and maximum concentration alarm in order to ensure that the prescribed oxygen concentration is delivered to the patient 6 8 2 Connecting the Oxygen Supply WARNING Ensure that the only gas supplied to the ventilator through the dedicated oxygen supply connector is medical grade oxygen The hose connecting the ventilator to the oxygen source must be designed exclusively for use with medical grade oxygen Under n
280. tion block into its slot 2 Tighten the captive screw to secure the exhalation block in place 3 Recalibrate the exhalation flow sensor Refer to section 10 1 Calibrating the Exhalation Flow Sensor on page 10 1 WARNING When an exhalation block is set up each time it is removed or after installing a new exhalation block on the machine it is essential that the exhalation flow sensor be recalibrated before the exhalation block is used Refer to section 10 1 Calibrating the Exhalation Flow Sensor on page 10 1 6 8 Oxygen WARNING The ventilator must not be used with flammable anesthetic substances Puritan Bennett 560 Ventilator Clinician s Manual 6 13 Installation and Assembly 6 8 1 Administering Oxygen WARNING Oxygen therapy for patients with respiratory failure is a common and effective medical prescription However be aware that inappropriate oxygen use may potentially lead to serious complications including but not limited to patient injury Oxygen administered to the patient is introduced from an external source into the machine through the oxygen connector at the rear of the ventilator It is then integrated into the total volume of delivered gas Remove the oxygen inlet connector from the back of the ventilator when external oxygen is not in use The specific oxygen flow to the patient depends on the physiological characteristics of the patient and the ventilator settings The oxygen flow set
281. tional Vent Stop Alarm Intentional Ventilation Stop Alarm Ventilation has been switched off by the user caregiver and the ventilator is in stand by I T Ratio Inspiratory time versus total breath time ratio L litres a unit of volume Leak When ventilating with a double limb circuit in leak configuration it is the average parasitic leak during each cycle and over the past 24 hour period When ventilating with a single limb circuit there is no average leak Puritan Bennett 560 Ventilator Clinician s Manual l 3 Glossary LED Light Emitting Diode used as indicator lights on the ventilator s front panel lpm Litres Per Minute a unit of volume flow rate Machine Hours Counter for the total ventilation time since manufacture or the last CPU board change Mains AC power supply MAP Mean Airway Pressure Average pressure during a ventilation cycle Max Leak The maximum alarm setting of a high leakage threshold An alarm will be triggered in the event the calculated leakage is exceeded Max Rtot Total breath rate The maximum alarm setting to prevent hyperventilation or ventilator autotriggering The HIGH RATE alarm will be triggered if the total breath rate exceeds the maximum limit set Max P Maximum Inspiration Pressure Max P allows the ventilator to adjust the inspiratory pressure up to a maximum limit in order to reach the target tidal volume Vt Target Mbar An abbreviation for mill
282. tive End Expiratory Pressure PEEP 3 19 Pressure Control P Control 3 79 Pressure Support P support 3 19 Respiratory rate Rate 3 19 Rise Time 3 27 PSV mode 3 1 Apnea Time 3 4 Backup R 3 4 Expired Tidal Volume VTE 3 6 Fraction of Inspired Oxygen FIO2 3 6 Inspiratory Tidal Volume VTI 3 6 Inspiratory Trigger Sensitivity I Sens 3 3 Max Leak 3 6 Max P Maximum Inspiration Pressure 3 5 Max Rtot 3 6 Min Max Inspiration Time Min Time Max Time 3 5 Positive End Expiratory Pressure PEEP 3 3 Pressure Support P Support 3 2 Rise Time 3 3 VT Target Target Tidal Volume 3 5 PSV mode Exhalation sensitivity E Sens Exhalation Sensitivity 3 4 V A C mode 3 14 Expired Tidal Volume Control VTE 3 17 Flow Shape Ramp 3 15 Fraction of Inspired Oxygen FIO2 3 17 LE I T 3 15 Sens Inspiratory Sensitivity 3 16 Peak Inspiratory Pressure PIP 3 16 Positive End Expiratory Pressure PEEP 3 15 Rate 3 75 Sigh rate 3 16 Sigh VT 3 16 Volume Control Vt 3 75 V SIMV mode 3 23 3 26 Apnea Time 3 26 E Sens exhalation sensitivity 3 26 Expired Tidal Volume VTE 3 28 Fraction of Inspired Oxygen FIO2 3 28 Sens Inspiratory Sensitivity 3 25 Time 3 26 Inspiratory Tidal Volume VTI 3 27 Inspiratory Time Insp Time 3 25 Peak Inspiratory Pressure PIP 3 27 Positive End Expiratory Pressure PEEP 3 24 Pressure Support P support 3 24
283. to be damaged If any signs of damage are evident contact your equipment supplier or Covidien 4 Clean the ventilator with a mild soap solution if necessary refer to chapter 9 Cleaning 5 Ensure that the air inlet filter is installed Puritan Bennett 560 Ventilator Clinician s Manual G 1 Unpacking and Preparation Figure G 1 Puritan Bennett 560 Ventilator Figure G 2 Dual Bag G 2 Puritan Bennett 560 Ventilator Clinician s Manual H Parts and Accessories Table H 1 provides a list of accessories that are available for the Puritan Bennett 560 Ventilator To order parts or accessories contact your equipment supplier or Covidien representative Note The ventilator is delivered with the following items a printed User s Manual a CD with Clinician s Manual printed copy available upon request one patient circuit with valve one set of six 6 combination foam fine particle air inlet filters one carrying bag one O connector and one AC power cable Table H 1 List of Consumables and Accessories Description Carrying bag grey Oxygen inlet connector Ventilator Cart Dual Bag delivered with Backpack Padded Straps 2 ea Suspension belt Carrying belt To minimise the risk of damage you must use the ventilator s Dual Bag to transport the ventilator See Figure G 2 on page G 2 AC mains power cable DC power cable for connection to an external DC power source such as a car
284. to see if alarm clears If not replace the ventilator and call your customer service representative Check that FIO sensor is properly connected or Recalibrate FIO sensor or Replace FIO sensor No connection of the proximal pressure l ees Reconnect the proximal pressure line tube when ventilation starts Reconnect the connection line or replace it if obstructed Check for moisture or occlusion of the proximal line Reduce humidifier temperature Switch to a heated wire circuit Restart ventilator to see if alarm clears If not have a qualified technician replace the defective component s and call your customer service representative Nurse Call or remote alarm system is Connect the Nurse Call or remote alarm disconnected cable to the ventilator Carefully monitor the patient to detect possible alarm triggering and call for the maintenance technician Check and adjust the prescribed Loss of memorised parameters parameters if necessary Software versions have changed enre ana ses baal TO PEARES parameters if necessary The ventilation settings are not compatible Connect exhalation valve Decrease PIP to less than 30 mbar in absolute pressure Increase PEEP to more than 3 mbar Note Always consult the clinician before changing PEEP FIO pressure volume or Rate settings Puritan Bennett 560 Ventilator Clinician s Manual Alarms and Troubleshooting Table 5 2 Alarms and Cor
285. tt 560 Ventilator Clinician s Manual V SIMV Mode Parameters and Setting Ranges Insp Exh VEN 101SE A Figure 3 11 Exhalation trigger sensitivity PIP Min and Max Alarm Settings PEAK INSPIRATORY PRESSURE A minimum and maximum pressure alarm threshold must be set The Min PIP or Min Pressure setting determines the trigger threshold for the PATIENT DISCONNECTION alarm Refer to chapter 5 Alarms and Troubleshooting A WARNING The setting of the LOW PIP alarm must be adjusted for the patient but must also be set high enough to allow the PATIENT DISCONNECTION alarm to trigger properly Perform the Low Pressure Test refer to section F 1 Low Pressure Test on page F 1 to ensure the LOW PIP alarm is properly set The Max PIP or Max Pressure setting determines the level of pressure which is not to be exceeded during the inspiratory phase When this level is reached inspiration is terminated the device switches to exhalation and a High PIP alarm is triggered Refer to chapter 5 Alarms and Troubleshooting The difference between the Min PIP and Max PIP settings is limited to a minimum of 8 mbar Their settings are also limited by that of PEEP thus Min PIP must be greater than PEEP by at least 2 mbar and Max PIP must be greater than PEEP by at least 10 mbar A change in the PEEP level may lead to automatic changes in the Min PIP and or Max PIP thresholds so that these differences are alway
286. tt product representative for further information 7 7 1 USB Memory Device Specifications Table 7 2 USB Memory Device Specifications USB compatibility USB flash memory USB 2 0 or USB 1 1 32 bit format Number of files Maximum 999 sector size 512 2 048 bytes USB size 128 Mb to 4Gb To guarantee accuracy of transfer time at least 10 of the USB memory device capacity must be free 7 7 2 USB Menu To access the USB menu when a USB memory device is connected Press the MENU key several times until the USB Menu appears USB MEMORY DEVICE PB560C70 SiN 40966K0001 m Transfer Continuously OFF O Transfer Trends OFF o Erase Key OFF Figure 7 24 Selecting the USB Menu In case of high priority alarm activation the ventilator will automatically display the alarm page To return to the USB Menu press the MENU CD key The adjustable parameters in this menu are e Transfer continuously e Transfer trends e Erase key 7 7 3 Transfer Continuously Up to 48 hours worth of data can be transferred from a ventilator to a USB memory device To record continuously the USB memory device must be permanently connected to the ventilator and ventilation is active The following data will be recorded to the USB memory device e Monitoring pressure inspired flow exhaled flow and leak waveforms e Trends leaks VTI VTE Rate I E M Vol PIP and PEEP measurements The data can be accessed by a doctor or service provider using
287. tup Menu PIP allows you to determine inspiratory Absolute pressure In this configuration PIP and PEEP are related and their settings must maintain a minimum difference between the two of 2 mbar in leak configuration and 5 mbar in valve configuration PEEP Positive End Expiratory Pressure PEEP allows you to determine the level of pressure maintained during the exhalation phase When Relative Pressure is set to YES in the Setup Menu the sum of PIP and PEEP must not exceed 55 mbar When relative pressure is set to OFF PIP and PEEP are related and their settings must maintain a minimum difference between the two of 2 mbar in leak configuration and 5 mbar in valve configuration The ventilation mode can be adjusted without PEEP PEEP is nearly 0 mbar when set to OFF in valve configuration In leak configuration the minimum PEEP setting is 4 mbar Rise Time This parameter is used during the inspiration phase to adjust how the pressure setpoint will be reached This setting indirectly defines the minimum inspiratory time The different levels available are as follows Rise time 200 ms Rise time 2 400 ms Rise time 31 600 ms Rise time 74 800 ms These time ranges are determined by the combination of the pressure setting required the breath rate and the physiological conditions of the patient The pressure rise time built up at each cycle depends on the inspiratory time corresponding to the combinati
288. ult in autotriggering The sound level of the alarms should be adjusted according to the installation environment and the size of the area monitored by the patient s caregiver Ensure that the alarm sound apertures at the front of the device are never obstructed A Warnings Regarding USB Memory Device Always verify the file ID before using a USB memory device to transfer data between the ventilator and a PC AN Warnings Regarding Maintenance Never use a ventilator or any components or accessories that appear to be damaged If any signs of damage are evident contact your equipment supplier or Covidien To ensure proper servicing and avoid the possibility of physical injury to personnel or damage to the ventilator only personnel authorised and qualified by Covidien should attempt to service or make authorised modifications to the Puritan Bennett 560 Ventilator If you cannot determine the cause of a problem with your ventilator contact your equipment supplier Do not use the ventilator until the problem has been corrected To ensure proper performance of the ventilator the preventative maintenance schedule should be followed For further information contact Covidien On a daily basis ensure the proper connection and operation of the patient circuit If a problem with the ventilator is suspected FIRST CHECK THAT THE PATIENT IS NOT IN DANGER If necessary remove the patient from the ventilator and provide an alternative means o
289. up ventilators or those in storage should be connected to an AC power source to protect the integrity of the battery Note Buzzer and battery alarms may occur when the unit is first powered on after the internal battery has been completely drained Connect to an AC power source and recycle power In the event of AC power interruption or disconnection of the external AC or DC power supply the ventilator automatically switches to its internal battery and the following events occur e The Battery fj symbol is displayed at the top on the general information line e Battery reserve capacity is displayed on the right of the fj symbol e The INTERNAL BATTERY indicator at the top left of the ventilator s front panel is continuously lit Figure 8 1 Ea covi ows A Figure 8 1 Internal Battery Indicator 8 2 Puritan Bennett 560 Ventilator Clinician s Manual Battery Operation e A loss of external supply alarm is activated If ventilation is stopped the internal battery reserve capacity is displayed as a percentage of battery charge Refer to Figure 8 2 a PC P A C reL 145 o PIP 15 mbar OoPEEP OFF meth 14359 mL o Rise Time 72 i Leak 0 0 Lpm o Rate 13bpm y M vol 0 0L o lE 1 2 0 m Rate 18bpm o l Sens 2 B IE 41 2 4 ovtTarget 420mL Eey gt Max P 48 mbar i o Preferences mbar Figure 8 2 Battery Reserve Capacity as a Percentage If the ventilator is running the internal battery reserve
290. ure 3 2 Figure 3 3 Figure 3 4 Figure 3 5 Figure 3 6 Figure 3 7 Figure 3 8 Figure 3 9 Figure 3 10 Figure 3 11 Figure 4 1 Figure 4 2 Figure 4 3 Figure 4 4 Figure 4 5 Figure 4 6 Figure 4 7 Figure 4 8 Figure 4 9 Figure 4 10 Figure 4 11 Figure 4 12 Figure 4 13 Figure 4 14 Figure 4 15 Figure 5 1 Figure 5 2 Figure 5 3 Figure 5 4 Figure 5 5 Figure 5 6 Figure 5 7 Figure 5 8 Locations of Labels Top Front View 0 ccc ccc cece ence eee eeeeeeeeees 1 15 Locations of Labels Front Left View 0 ccc cece cece cece eee e enna eeeenes 1 16 Location of Labels and Markings Rear VieW cccce eee e cece eee eeeees 1 16 Location of Labels Bottom View cece cece eee eee e enn e eee eeeenes 1 17 FROME ANG errer rera R AES EEEE corereue pxeannecesaseseeas eat 2 4 BACK ANliac cues eedetaqeacecns sense sndas EE I EE 2 5 COMMOMP ANG P near aeeave cospensteesssessecohedee anes E E E 2 6 VeEMUlaIONMCMUNDISDIAN lt t 025eecetuae baanseaecccecesutetethuceesasd cacccaeseaeses 2 7 AE MONU 4 j224 d24ceeeerteued se2e0seeeeaseeerassnecamtaaesiensecsetaaceaeeeass 2 8 Waveforms MenU i554 nssosenebesheeneeenaesdes Kengusnyeysdcwata were renee naeas 2 9 USB Memory Device Menu 2 cece cece e cece eee eeeeeeeeeeeennnes 2 10 Menus in PSV Mode with exhalation valve configuration cce eee ee eee 3 1 Menus in PSV Mode with leakage configuratio
291. ure 6 4 Figure 6 5 Figure 6 6 Figure 6 7 Figure 6 8 Figure 6 9 Figure 6 10 Figure 6 11 Figure 6 12 Figure 6 13 Figure 6 14 Figure 6 15 Figure 6 16 Figure 6 17 Figure 6 18 Figure 6 19 Figure 6 20 Figure 7 1 Figure 7 2 Figure 7 3 Figure 7 4 Figure 7 5 Figure 7 6 Figure 7 7 Figure 7 8 Figure 7 9 Figure 7 10 Figure 7 11 Figure 7 12 Figure 7 13 Figure 7 14 Figure 7 15 Figure 7 16 Figure 7 17 Figure 7 18 Figure 7 19 Figure 7 20 Figure 7 21 Figure 7 22 Figure 7 23 Figure 7 24 Figure 7 25 Figure 7 26 Figure 7 27 vi The Power Cable Holder 0 0 cc ccc ccc cece cece eee e eect e eee e eee neeeeeenaes 6 2 Inserting the Power Cable Holder Into the Notch cee ee cece eeeeeeees 6 3 Power Cable Connected to the Ventilator 0 0 ccc cece cece cence eee eeees 6 3 Power INGICALONS s secccceaasenseguacsnsnteeeuaserceasanrennecersaaaeasecndauaraes 6 4 Connecting the Ventilator to an External DC Power Source cece eee eees 6 5 Connecting the DC Power Cable to the Ventilator cc ccc ccc eee eee eee 6 5 Single Limb Patient Circuit With Exhalation Valve ccc cece cece eee eens 6 7 Double Limb Patient Circuit 0 ccc cece ccc eee cece tee e ee ee seen eeeeees 6 8 Close up of Exhalation Valve Tube and Proximal Pressure Tube 005 6 9 Single limb Patient Circuit Without Exhalation Valve cc
292. use an alternative means of ventilation should always be available in the event of a ventilator problem This is particularly true for ventilator dependent patients Supplementary observa tion appropriate for the patient s condition is also recommended To ensure that ventilation continues uninterrupted ensure alternative power sources are available AC power source extra batteries or an auxiliary DC car adapter Be prepared for the possibility of power fail ure by having an alternative means of ventilation ready for use particularly for ventilator dependent patients Do not start ventilation until you ensure that the device is suitably assembled that the air inlet filter is properly installed and is not obstructed and that there is proper clearance all around the unit Also ensure that the patient circuit is suitably connected to both the ventilator and the patient and that the patient cir cuit including all hoses is not damaged or obstructed Users must always possess an additional breathing circuit and exhalation valve while using the Puritan Bennett 560 Ventilator Verify the functionality of the alarm conditions before connecting the patient to the ventilator Refer to chapter F Alarms Tests Before starting ventilation always verify that all settings are properly set in accordance with the required prescription If the ventilator fails the alarm tests or if you cannot complete the tests refer to chapter 5 8 Troub
293. use to ensure it has its black O ring attached and in good condition Do not use an oxygen coupler with a missing damaged or worn O ring A Warnings Regarding Electromagnetic Interference e The Puritan Bennett 560 requires special precautions for electromagnetic compatibility and should be installed and started according to the recommendations found in Appendix B Specifications In particular the use of nearby mobile and portable communications equipment using radio frequencies such as mobile telephones or other systems exceeding the levels set in the IEC 60601 1 2 standard may affect its operation Refer to section B 10 Manufacturer s Declaration e The use of any accessory other than those specified with the exception of the power supplies or cables sold by Covidien may lead to an increase in electromagnetic emissions or a decrease in the equipment protection against electromagnetic emissions If the ventilator is used adjacent to such accessories or stacked with such devices the ventilator s performance should be monitored to verify normal operation Puritan Bennett 560 Ventilator Clinician s Manual 1 9 Safety Information 1 3 Symbols and Markings Table 1 1 Ventilator Symbols It is essential to read understand and follow these instructions before using the Puritan Bennett 560 Ventilator ISO 7000 0434A This symbol appears on the ventilator s back panel see Table 1 2 item 5 Type BF
294. value P A C Tidal volume Vt Range 50 mL to 2000 mL Resolution 10 mL Accuracy 10 ml 10 of setting Default value 500 mL Depends on Insp time R Rate in V SIMV and P SIMV Depends on Rate and I E I T in V A C Peak Inspiratory Pressure Range 5 mbar to 55 mbar in valve configuration PIP Range 5 mbar to 30 mbar in leak configuration Resolution 1 mbar Accuracy 1 mbar 10 of P Control PEEP setting Default value 15 mbar Depends on PEEP when Relative Pressure is set to YES Pressure control Range 5 mbar to 55 mbar in valve configuration P Control Range 5 mbar to 30 mbar in leak configuration Resolution 1 mbar Accuracy 1 mbar 10 of P Control PEEP setting Default value 15 mbar Depends on PEEP when Relative Pressure is set to YES Pressure support Range OFF or 5 mbar to 55 mbar in valve configuration P Support Range 5 mbar to 30 mbar in leak in valve configuration Resolution 1 mbar Accuracy 1 mbar 10 of P Support PEEP setting Default value 15 mbar Depends on PEEP when Relative Pressure is set to YES E Ratio I E Range from 1 1 to 1 4 Resolution 1 0 1 s Accuracy 50 ms or 10 whichever is greater Default value 1 2 I T Ratio I T Range 20 to 50 Resolution 1 Accuracy 50 ms or 10 whichever is greater Default value 33 B 5 Puritan Bennett 560 Ventilator Clinician s Manual Specifications Table B 10 Ventilator Range Resolution and Accuracy Continued Venti
295. valve symbol e No exhalation valve x symbol 4 Status monitored data window 5 Alarm message window e Ventilation stopped Standby e For Active alarms scrolls through displays the message PRESS active alarm messages in flashing TO START VENTILATION reverse video e Ventilation on parameters are For Inactive alarms displays the last monitored and displayed alarm along with its trigger date e The Inspiratory Effort Detected and end of event time symbol C appears adjacent to the Refer to chapter 5 Alarms and monitored I E ratio when the Troubleshooting for more 2 8 ORtot bpm OFiO co A 3 oO Alarms Logs 1 Ena is 3 a Alarms Logs patient actively triggers a breath information Figure 2 5 Alarm Menu PB560C03 4 TO START VENTILATION 5 PB560C04 TAFAL FEEF mbar Mol 0 0L 4 1 2 2 5 Access line to Alarm Logs menu Highlight this line and press the ENTER G key to display the Alarm Logs menu Refer to manual section 5 3 Alarm Logs Menu on page 5 3 Puritan Bennett 560 Ventilator Clinician s Manual 2 10 Waveforms Menu The display of waveforms Figure 2 6 is optional and can be selected using the Menu key refer to chapter 4 Monitored Parameters The Waveform menu is only accessible when ventilation is active PB560C05 FIP 70 mbar PEEF 0 A mbar 2 n i Pho i E 1468 mL Rate WIE 13 178 bpm mL
296. ventilation time in hours and minutes over the previous 24 hour period Volume breath Inspiration of the selected volume delivered over the selected inspiratory time Puritan Bennett 560 Ventilator Clinician s Manual Index Symbols 5 18 A AC power connecting to 6 2 indicator 8 4 AC power cable disconnecting 6 4 securing to ventilator 6 3 AC POWER DISCONNECTION alarm message 5 7 5 15 Accessories cleaning 9 2 Dual Bag 6 18 Air circulation Warning 7 3 6 1 Air inlet filter 6 11 replacement interval 70 6 replacing 10 5 Air inlet filter replacing figure 10 6 Air outlet antibacterial filter replacement interval 70 6 Air transport air transport warning 8 7 Air transportation standard B 15 rules for carry on baggage 8 1 use on commercial aircraft 2 7 Alarm levels 5 7 Alarm Logs menu dismissing automatically 5 4 dismissing manually 5 4 Alarm messages AC POWER DISCONNECTION 5 7 5 15 APNEA 5 7 5 15 BATTERY FAULT15 7 5 15 8 4 BATTERY FAULT2 5 7 5 16 BUZZER FAULT1 5 7 5 16 BUZZER FAULT2 5 7 5 16 BUZZER FAULT3 5 7 5 16 BUZZER FAULT4 5 8 5 16 BUZZER LOW BATTERY 5 7 5 16 CALIBRATE FIO2 5 8 5 16 CALIBRATION FAIL 5 8 5 16 10 3 CHECK BATTERY CHARGE 5 8 5 16 CHECK EXH VALVE 5 8 5 17 CHECK EXH VALVE PRESSURE 5 8 5 17 CHECK FIO2 SENSOR 5 8 5 17 CHECK PROXIMAL LINE1 5 8 5 77 CHECK REMOTE ALARM 5 9 5 17 CHECK SETTINGS 5 9 5 17 CONNECT VALVE OR CHA
297. w Alarm Volume setting before seven 7 seconds elapse Current hospital standards require a minimum sound level of 55 dB A at a distance of 3 metres 9 84 feet which corresponds to the lowest possible volume setting The alarm sound level range is 65 dB A to 85dB A measured at 1 metre 3 28 feet If a high priority alarm is not paused within 60 seconds of activation the sound level automatically raises to 85 dBA regardless of the original setting The default setting for Alarm Volume corresponds to a level of 75 dB A 7 3 5 Key Sound This setting is used to select the sound emitted when pressing keys on the ventilator s keyboard To set Key Sound 1 Select the Key Sound parameter on the display 2 Select one of the following four options e OFF No sound is emitted when a key is pressed e Key tone A clock sound is emitted when a key is pressed e Accept tone A beep sounds when ENTER Cv is pressed to confirm a setting e All tones on A clock sound is emitted when all keys are pressed and a beep sounds when ENTER Vv is pressed to confirm a setting 3 Confirm the new Key Sound setting by pressing ENTER WY before seven 7 seconds elapse The default setting for Key Sound is Accept tone Note Whatever the selected Key Sound setting pressing the VENTILATION ON OFF key triggers a beep at ventilation start and a double beep at ventilation stop 7 3 6 Intentional Vent Stop Alarm
298. wer supply lines 1 kV for input output lines 1 kV lines lines 2 kV lines earth lt 5 Ur gt 95 dip in U for 0 5 cycle 40 Ur 60 dip in U for 5 cycles 70 U7 30 dip in U for 25 cycles lt 5 Ur gt 95 dip in Ur for 5 s 6 kV contact 8 kV air 2 kV for power supply lines 1 kV for input output lines 1 kV lines lines 2 kV lines earth lt 5 Ur gt 95 dip in U for 0 5 cycle 40 U 60 dip in Uy for 5 cycles 70 Ur 30 dip in Uy for 25 cycles lt 5 Ur gt 95 dip in U for 5 s Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 AC power mains quality should be that of a typical commercial or hospital environment AC power mains power quality should be that of a typical commercial or hospital environment AC power mains power quality should be that of a typical commercial or hospital environment If the user of the ventilator requires continued operation during power mains interruptions it is recommended that the ventilator be powered from an uninterruptible power supply or a battery Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment Note Uvis the AC mains voltage prior to application of the test level Puritan Bennett
299. with apnea ventilation PSV ST Safety Net Incorporated in the ventilator design is an alarm system that continuously monitors both patient and machine for signs of specific errors or faults that could lead to an unsafe condition Should any of these errors or faults be detected the alarm system announces the specific alarm condition both audibly and visually The machine related alarm conditions are factory set whereas the patient related alarm conditions are defined by alarm threshold values selected by an operator a clinician or a caregiver For more information refer to chapter 5 Alarms and Troubleshooting Settings A software key known as the Locking Key restricts access to ventilation parameter settings and ventilation mode changes in order to distinguish between clinician usage and patient usage refer to section 7 8 Locking the Control Panel on page 7 25 Oxygen Enrichment Oxygen may be supplied from an external low pressure source but the oxygen flow must be limited to 15 lpm 50 kPa 500 mbar The ventilator automatically compensates for the extra flow created by the external oxygen supply refer to chapter 6 Installation and Assembly Breathing Circuit The ventilator can be used with a single or double limb patient circuit If exhaled volume monitoring is required such as ventilator dependant patients use the double limb circuit for exhaled tidal volume monitoring For more i
300. y it can be set to OFF Max P MAXIMUM INSPIRATION PRESSURE Max P allows the ventilator to adjust the inspiratory pressure up to a maximum limit in order to reach the Target Tidal Volume Vt Target PIP and Max P are related and the difference between them must be less than 20 mbar Max P is not displayed when VT Target is set to OFF VTI Min and or Max Alarm Settings INSPIRATORY TIDAL VOLUME It is possible to set a Min and or Max Tidal Volume alarm threshold for the patient s inspired tidal volume during a cycle This setting is used to trigger an alarm if the tidal volume inspired by the patient is lower than the minimum threshold set LOW VTI alarm or greater than the maximum threshold set HIGH VTI alarm Refer to chapter 5 Alarms and Troubleshooting Puritan Bennett 560 Ventilator Clinician s Manual P A C Mode Parameters and Setting Ranges Min VTI and Max VTI are related and their settings must be set to values that maintain a minimum difference of 20 ml between the two It is not mandatory to set the minimum and maximum VTI alarm limits When the minimum and maximum VTI alarm limits are not set the display will read OFF for these settings VTE Min and or Max Alarm Settings EXPIRED TIDAL VOLUME A Min and or Max Tidal volume expired by the patient can always be set but can only be used ina double limb circuit configuration These thresholds can be set to trigger an alarm
301. y jelin 10 ae Rew f 7 Identification Label Figure 1 4 10 PC Connection marking Figure 1 3 7 psi max 50 kPa max 15 lpm max INLET 2 Oxygen Inlet Marking and Label Figure 1 3 5 Air Inlet Label Figure 1 3 A gt Sn Location of AC Power Cable Connector 100 240 V Y 60 60 Hz 180 VA 8 AC Power Mains Cable Connector Marking Figure 1 3 i 11 USB Port marking Figure 1 3 Puritan Bennett 560 Ventilator Clinician s Manual 3 Exhalation Valve and Patient Pressure Connection Label Figure 1 1 Figure 1 4 rol 6 Exhaled Gas Outlet Label Figure 1 2 12 30V EN Co Co Co Location of DC oO oO Power Cable O O Connector O O 83 a BPS A 9 External Cable Connector Marking Figure 1 3 12 Nurse Call Cable Connector Marking Figure 1 3 Labels Identification and Instruction Information Table 1 2 Ventilator Labels and Markings Continued 13 FiO Label Figure 1 1 Figure 1 4 Note The item number callouts in the following figures refer to those listed in Table 1 2 Figure 1 1 Locations of Labels Top Front View Puritan Bennett 560 Ventilator Clinician s Manual 1 15 Safety Information VEN_10029_6 6 Figure 1 2 Locations of Labels Front Left View Linn oo ma eee Mees 11 NM 10 Ic i H 8 Or Or 5 I F 7 i E ni ww U VEN War _ A Figure 1 3 Location of Labels an
302. y when filters are replaced e To ensure proper performance of the ventilator use a patient circuit recommended by Puritan Bennett in this manual refer to chapter 6 Installation and Assembly and Appendix H Parts and Accessories The total specified length of the patient circuit tubing as measured from the ventilator outlet to the ventilator inlet is 1 1 metres 3 6 feet to 2 0 metres 6 6 feet The tubing must conform to all applicable standards and must be fitted with 22 mm terminals that also conform to all applicable standards Ensure that both the length and the internal volume of the patient circuit are appropriate for the tidal volume a corrugated tube of 22 mm for adult patients and a corrugated tube of 15 mm for pediatric patients with a tidal volume lower than 200 ml e To ensure proper performance of the ventilator use only accessories including oxygen accessories approved and recommended by Covidien See Appendix H Parts and Accessories or contact your customer services e When using non invasive ventilation NIV without an exhalation valve use a vented nose or face mask or anon vented combined with a leak accessory When using non invasive ventilation NIV with an exhalation valve use a non vented mask e Before using the Nurse Call system ensure that its connections are secure and it operates properly For more information contact Covidien Puritan Bennett 560 Ventilator Clinician s Manu

560 VENTILATOR CLINICIAN`S MANUAL

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