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Legendair XL2 Clinician`s Manual.book

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1. ccc cece ee eee eee eees 4 3 Power Cable Connected to the Ventilator 0 0 ccc cc ccc ccc ce cece teen eees 4 3 POW CE INGICALONS va ae 4 4 Connecting the Ventilator to an External DC Power Source 0e eee eees 4 5 Connecting the DC Power Cable to the Ventilator ccc cece cece eee eee 4 6 Single Limb Patient Circuit s0 54244s0 cia siceeeRtues Ciand Midaded ns Hades Gua ARS 4 8 Double Limb Patient Circuit eese yi n dala ales salvea stea ad seder es E a 4 9 Close up of Exhalation Valve Tube and Proximal Pressure Tube 08 4 9 ATEN sca actitronsts st atelier debe E dh Snr Sareea O pao eens eee t 4 11 BaCCehla Tiel EEE EE SE TE EE Peta E E E eed Cee 4 11 pe 10 2 M PEER EEE SEE VE nese his bei INE T NN 4 12 Removing the Exhalation BIOCK ccc ccc ccc cece eee eee e eee eennenes 4 13 Rear Panel Oxygen CONNECtOFr 0 ccc ccc cece tence eee eee eee eee eeeeneees 4 14 Connecting the Oxygen Supply SysteM ccc eee eee cece ee eeeeeees 4 15 Disconnecting the Oxygen Supply SysteM ccc ccc cc cee eee e eee eeeeees 4 15 Using the Dual Bag ACCeSSONY osc 2ixeveduaweiawd oe eedeeeodencaden danas kakene 4 17 Connecting the Nurse Call Cable 0 ccc cece eee eee e ence eee eeeeeeee 4 18 Turning on the Ventilator vas a esd esoi hace hdata Sine iblea cde ad ive Wades bev es vee es 5 1 Welcome Menu Screen aaauuuununnnannnnnenennuununnnunannnenenennnnnnnene 5 2 Prompt
2. Verify the proper appearance and cleanliness of the ventilator the proper appearance and cleanliness Verify the proper appearance and cleanliness of the ventilator the ventilator Verify all of the labels and markings on the ventilator are clear and legible Pass E 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 Pass 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 VENTILATOR ON OFF key flash Ensure also that the two alarm buzzers sound Perform the Functioning Alarms Test pA Verify the alarm volume is adapted to the patient environment Ensure that you know how to charge the internal battery Refer to E Pass chapter 6 Internal Battery Puritan Bennett 540 Ventilator User s Manual B 1 Operational Verification Checklist Table B 1 Operational Verification Checklist Continued Verify that the preventive maintenance schedule for the ventilator is I followed L nass Ensure the patient breathing circuit is correctly attached to the ventilator with all the necessary components and is free f
3. e The ventilator and patient circuit should always be placed so as to provide a secure comfortable fit for the patient e The patient circuit should always be positioned to avoid hindering the patient s movements to prevent accidental disconnection and to minimize the risk of patient strangulation Puritan Bennett 540 Ventilator User s Manual Patient Circuit N WARNING e The patient circuit is intended for single use by a single patient and should be changed according to the manufacturer s recommendations Refer to the instructions for use supplied by the manufacturer of the patient circuit included with the ventilator Before assembling or reassembling the patient circuit and on a daily basis inspect the hoses and all other components to ensure that there are no cracks or leaks and that all connections are secure To ensure correct performance of the ventilator the patient circuit used must be one of those recommended by Puritan Bennett in this manual The connections of the outlet towards the patient and the return to the exhalation block with a double limb circuit must be made with a 3 6 feet 1 10 m to 6 6 feet 2 00 m long tube between the ventilator and the patient The tube must conform to applicable standards and be fitted with 22 mm terminals that also conform to standards Ensure that the length and the internal volume of the patient circuit are compatible with the patient s tidal volume a ringed tub
4. Figure 4 6 Connecting the DC Power Cable to the Ventilator 2 Push the DC power cable onto the ventilator s DC power connector Figure 4 6 item 2 e You will hear a locking click e The DC POWER indicator on the top left corner of the ventilator illuminates see Figure 4 4 To disconnect the DC power cable from the ventilator slide the locking ring Figure 4 6 item 3 back and pull the plug away from the ventilator s rear panel to disengage it An ON INTERNAL BATTERY alarm signals an automatic switch to the internal battery in case the external DC power source fails or becomes disconnected Patient Circuit N WARNING J 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 e If exhaled volume monitoring is required such as ventilator dependant patients use the double limb circuit for exhaled tidal volume or minute volume monitoring In this configuration the expired volume is monitored to ensure correct patient ventilation and identify any leaks or other problems in the patient circuit Similarly the Low VTE setting must be properly set to warn in the event of patient suffocation e The ventilator and patient circuit should always be placed so as not to hinder the patient s movements prevent accidental disconnection and reduce the risk of patient strangulation by the circuit
5. IF PERSISTS REPLACE VENT Have a qualified technician replace the Defective inspiratory flow sensor defective component s and call your customer service representative No connection of the proximal pressure i ne Reconnect the proximal pressure line tube when ventilation starts CHECK PROXIMAL LINE Proximal pressure line disconnected or Reconnect the connection line or IE PERSISTS obstructed replace it if obstructed REPLACE VENT Have a qualified technician replace the defective component s and call your customer service representative Loss of memorized parameters i CHECK SETTINGS Check and nes the prescribed Software versions have changed parameters If necessary Large leakage detected on the patient CHECK CHANGE circuit return limb during the inspiratory ROP Ge Wee ONE EXH VALVE1 phase control tube Defective proximal pressure sensor or internal leak of the machine Have a qualified technician replace the IF PERSISTS Contaminated or defective expiratory flow ea U andal REPLACE VENT sensor efective components and Call your customer service representative 3 16 Puritan Bennett 540 Ventilator User s Manual Troubleshooting Table 3 2 Alarms and Corrective Actions Continued Alarm Message or Possible Reason s For The Alarm Event Corrective Action s Symptom CHK VOL INSP TIMESETTINGS Defective inspiratory flow sensor or internal Replace the defective device s and ha
6. 6 Place the battery cover containing the replacement battery back onto its slide rails within the ventilator Caution When tightening the screws in the next step push on the battery cover from the rear towards the front to take pressure off the cover mounting brackets otherwise the cover mounting brackets may break when the screws are tightened 7 Install the three Torx screws Figure 6 3 item 1 to secure the battery cover Figure 6 3 item 2 to the ventilator and tighten the screws with the Torx T10 screwdriver Puritan Bennett 540 Ventilator User s Manual 6 7 This page intentionally blank 7 Cleaning N 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 double limb circuit is used is recommended To reduce the risk of infection be sure to wash your hands thoroughly before and after handling the ventilator or its accessories 7 1 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
7. Identification and Instruction Information Table 1 1 Ventilator Symbols Continued Year of Manufacture KV Audio Paused EX This symbol means the sounding of audible alarms is currently disabled For more information refer to section 3 4 Silencing the Audible Portion of Alarms N Alarm Paused reset cancelled N This symbol means one or more alarms have been paused or reset cancelled For more information refer to section 3 5 Resetting Pausing Alarms Single patient use only ISO 7000 1051 This symbol means that the labeled device is for use by a single patient only Refer to Table 1 2 item 5 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 via a USB connector See Figure 2 2 item 10 Not currently used PC connector This symbol indicates a port that can be used by authorized Puritan Bennett service personnel for software maintenance See Figure 2 2 item 7 1 5 Labels Identification and Instruction Information Various labels or specific markings are affixed to the ventilator that describe precautions to be taken for the
8. Table 8 1 Consumables and Replacement Intervals Elements Recommended Replacement Intervals Air Inlet Filter Every two months or more often depending on Foam Fine Particle the extent of soiling Inspiratory Bacteria Filter See manufacturer s recommendation Patient Circuit See manufacturer s recommendation Exhalation Block 3 months for each new patient Note For more information regarding parts and accessories for the Puritan Bennett 540 Ventilator contact your service representative or www puritanbennett com N WARNING e 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 Failure to observe these recommendations may result in a loss of performance excessive overheating a loss of certain 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 Puritan Bennett 540 Ventilator User s Manual 8 3 Service Assistance 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
9. The 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 4 18 Puritan Bennett 540 Ventilator User s Manual Connecting the Nurse Call Cable e The ventilator signals an alarm using a normally open NO or a normally closed NC signal e Aremote 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 540 Ventilator User s Manual 4 19 Installation and Assembly This page intentionally blank 4 20 Puritan Bennett 540 Ventilator User s Manual 5 Operating Procedures 5 1 Turning on The Ventilator Caution After storage of the Puritan Bennett 540 Portable Ventilator in an atmosphere that differs significantly in temperature from where it is installed typically 36 F 20 C stabilize the device at room temperature for at least two 2 hours prior to starting it To turn the ventilator on do the following 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 5 1 below NOTE I O switch cover not shown here Figure 5 1 Turning on the Ventilator The following events occur e The v
10. before any maintenance operation and before storing the ventilator 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 7 1 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 The ventilator should never be immersed in any liquid and any liquid on the surface of the device should be wiped away immediately To clean the surface of the ventilator do the following iF 4 Dip a clean soft cloth into a mixture of mild soap and water or other approved cleaning solution Refer to Table 7 1 for a list of approved cleaning solutions Squeeze the cloth thoroughly to remove excess liquid Lightly wipe the external casing of the ventilator taking care not to allow excess moisture to enter any of the openings on the ventilator s surface See the warning above Dry the ventilator surface with a clean soft lint free cloth Table 7 1 Approved Cleaning Solutions for Exterior Ventilator Surfaces Description Product Names Mild dishwashing detergent Joy or equivalent 10 chlorine bleach 90 tap water Clorox or equivalent Puritan Bennett 540 Ventilator User s Manual 7 1 Cleaning Table 7 1 Approved Cleaning Solutions for E
11. C the ventilator can be expected to operate on internal battery power for the average durations shown in Table 6 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 Puritan Bennett 540 Ventilator User s Manual 6 1 Internal Battery Table 6 1 Internal Battery Reserve Capacity Displayed Values Average Operating Time on Internal Battery Power Vt 200 ml 5 ml PIP 10 cmH 0 2 cmH gt 0 11 hours 10 Rtot 20 bpm Vt 300ml 5 ml PIP 20 cmH30 2 cmH 0 9 hours 10 Rtot 15 bpm Vt 500 ml 5 ml PIP 30 cmH30 2 cmH gt 0 6 5 hours 10 Rtot 15 bpm Vt 750 ml 5ml PIP 45 cmH30 2 cmH 0 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 6 2 Battery Operation Caution Before operating the ventilator on its internal battery ensure that the battery is fully charged and that the charge holds see section 6 4 Recharging the Battery on page 6 4 Note Speaker and battery alarms may occur when the unti is f
12. Safety Information NOTE To view labels items 11 and 14 Battery Cover and Internal Battery must be removed Refer to section 6 6 Replacing the Battery Figure 1 5 Location of Labels Bottom Front View 1 18 Puritan Bennett 540 Ventilator User s Manual 2 Ventilator Overview 2 1 Indications for Use The Puritan Bennett 540 Ventilator is indicated for the continuous or intermittent mechanical ventilatory support of patients weighing at least 111b 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 physician It is essential to read understand and follow these instructions before using the Puritan Bennett 540 Ventilator Target Patients Specifically the ventilator is applicable for adult and pediatric patients who require the following general types of ventilatory support as prescribed by an attending physician 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 Target Operators The ventilator may be operated by e Respiratory therapists e Physicians e Nurses e Home care providers e Patient and patient s
13. 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 Puritan Bennett 540 Ventilator User s Manual Alarm Logs Menu In the event several alarms are activated at the same time the highest priority audible and visual alarm is highlighted however all active messages are displayed in the sequence in which they occurred 3 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 cD key to access the alarm setting menu if this is not the menu currently displayed 2 Press the DOWN y 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 Itt 1266 me MAP gt OcmH20 PEEP demH20 LE 14 2 DEVICE FAULT2 REPLACE VENT ALARM LOG AC POWER DISCONNECTION LOW PRESSURE DISCONNECT APNEA HlisH PRESSURE AC POWER DISCONNECTION LOW BATTERY APNEA JUN 02 06 11 20pm LOW PRESSURE DISCONNECT JUN 02 06 10 14am INVERSED E MAY 17 06 12 24pm O Reactivate Paused Alarm m Back Note W
14. controlled by the selected Inspiratory Time setting Used in Assist Control mode Pressure 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 expiratory sensitivity setting for the inspiration when the ventilator cycles into exhalation Available in SIMV or Spontaneous modes PSI Pounds Per Square Inch Rebreathing The patient breathes his her exhaled gas Puritan Bennett 540 Ventilator User s Manual Respiration rate The number of breath cycles inspiration expiration completed within one minute Normal resting adult respiratory rates are from 16 20 breaths per minute bpm Rtot Parameter measured by the ventilator equal to the total number of breaths per minute bpm Volume breath Inspiration of the selected volume delivered over the selected inspiratory time 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 of a spontaneous breath The Puritan Bennett 540 Ventilator is flow triggered with sensitivity levels in the range from 1 to 5 the lower the number the more sensitive the trigger Spontaneous A ventilation mode that delivers assisted breaths only Spontaneous mode does not provide breaths
15. correct 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 through Figure 1 5 Puritan Bennett 540 Ventilator User s Manual 1 13 Safety Information Table 1 2 Ventilator Labels and Markings See the User s Manual for more Information on how and when to test the ventilator CHECKOUT TEST 1 Verify the appearance and cleanliness of the ventilator 2 Inspect the AC power cord and replace if damaged 3 Connect the AC power cord 4 Check that all power indicators flash once 5 Turn the ventilator s power switch 1 0 on 1 6 Check that a single tone sounds VENT STD BY and alarm LEDs flash once then two tones sound ALARMS TEST WARNING Do not perform the Alarms Test with the patient connected to the ventilator Provide an alternate means of ventilation 1 Attach the patient circuit to the ventilator 2 Start ventilation using the ON OFF key 3 With the patient s end of the breathing circuit open walt several seconds and ensure that the PATIENT DISCONNECTION alarm Is triggered the red HP indicator flashes an alarm sounds and an error message Is displayed 4 Press the ALARM CONTROL key once to silence the alarm 5 Disconnect the AC power cord from the ventilator 6 Ensure
16. customer service representative POST FLASH Checksum Error Startup Replace the ventilator and call your DEVICE FAULT10 FLASH computed checksum does not customer service representative REPLACE VENT match memory setting DEVICE FAULT11 POST EEPROM Error Startup EEPROM does Replace the ventilator and call your REPLACE VENT not match memory setting customer service representative DEVICE FAULT12 POST Reference Voltage Error 5V or 10V Replace the ventilator and call your REPLACE VENT reference voltage error customer service representative DEVICE FAULT13 Replace the ventilator and call your Reconnect the device to an AC power outlet connect it to an external DC power source or replace the battery Internal battery capacity is less than EMPTY BATTERY 10 min or 2 battery operation Reminder the internal battery can be charged only when the ventilator connected to an AC power supply EXHSENS FAULT OR ae Check and properly connect the patient CIRCUIT FAULT Pete PaU Snir circuit connections overextended Puritan Bennett 540 Ventilator User s Manual 3 17 Alarms and Troubleshooting Table 3 2 Alarms and Corrective Actions Continued Alarm Message or Possible Reason s For The Alarm Event Symptom Adjustment of the High VTE level too low Inappropriate patient circuit Expiratory flow sensor not calibrated HIGH EXH VOLUME properly Defective expiratory flow sensor Adjustment of the High VTI le
17. use of Electrostatic Discharge ESD protection devices and knowledge of the following symbol s meaning id as well as using original spare parts and respecting quality assurance and traceability rules approved by Puritan Bennett Warranty Information regarding your product warranty is available from your sales representative or Puritan Bennett Extended Service The Puritan Bennett 540 Portable Ventilator offers extended service contracts warranties for purchase when the ventilator is purchased Please contact your local Covidien Puritan Bennett Sales or Service Representative for additional information Puritan Bennett 540 Ventilator User s Manual Preface 1 Preface For online technical support visit the SolvIT Center Knowledge Base by clicking the link at l http www puritanbennett com Here you will find answers D 0 V to frequently asked questions about the Puritan Bennett 540 Ventilator and other Puritan Bennett products 24 CENTER hours a day 7 days a week If you require further assistance contact your local Puritan Bennett representative or call Puritan Bennett Technical Support at 1 800 255 6774 Knowledge base Preface 2 Puritan Bennett 540 Ventilator User s Manual 1 Safety Information 1 1 Definitions This manual uses three indicators to highlight critical information Warning Caution and Note They are defined as follows N WARNING Indicates a condition that can endanger th
18. 0 Start Ventilation senioare inie ses oop beer cada 5 3 NN TIN 5 4 Internal Battery Indicator s rer S TT NTS 6 3 Power Indicators When Charging the Battery ccc cece cece eee e eens 6 5 Replacing the Battery ccc ccc ccc cece cence eee eee e eee e nese eeeeeeeees 6 6 Replacing the Air Inlet Filter 00 ccc ccc cece cece nent eee eeeeeeees 8 2 Puritan Bennett 540 Portable Ventilator 0 ccc ccc ccc ccc cee cette eeees C 2 BIE DET FEE EE EE ENE EEE ET EE EEE C 3 Puritan Bennett 540 Ventilator User s Manual vii This page intentionally blank Tables Table 1 1 Table 1 2 Table 3 1 Table 3 2 Table 3 3 Table 6 1 Table 7 1 Table 8 1 Table A 1 Table A 2 Table A 3 Table A 4 Table A 5 Table A 6 Table A 7 Table A 8 Table A 9 Table A 10 Table A 11 Table A 12 Table A 13 Table A 14 Table A 15 Table A 16 Table A 17 Table A 18 Table A 19 Table A 20 Table A 21 Table A 22 Table A 23 Table B 1 Table E 1 Table E 2 Ventilator SVIMDOIS gergasi Tin amie E ET a Seem cncerin wage Ge wig ea 1 10 Ventilator Labels and MarkingS cc ccc ccc ccc cece eee eee eee eeeeees 1 14 OVeEIVICW OL AIGINS eeann anea turns tuenehdoneh duis dduled baie ey dats en 3 7 Alarms and Corrective Actions 2 0 cc ccc ccc ccc ccc eee eee eee eee eeeeeees 3 14 Additional Problems and Corrective Actions 0 ccc ccc ccc cece eee eeees 3 22 Internal Battery Reserve Capaci
19. 12 replacement interval 8 2 Puritan Bennett 540 Ventilator User s Manual EXHSENS FAULT OR CRKT LEAK alarm message 3 10 3 17 F Faults technical 3 1 Filters 4 10 air inlet 4 10 antibacterial 4 1 I Front panel 2 3 H Heat safety device battery 4 1 HIGH DEVICE TEMP COOL VENT alarm message 3 10 HIGH EXH VOLUME alarm message 3 10 3 18 HIGH INSP VOLUME alarm message 3 10 3 18 HIGH MINUTE VOLUME alarm message 3 10 3 18 HIGH PRESSURE alarm message 3 11 3 18 HIGH RATE alarm message 3 11 3 19 Holder AC power cable 4 2 Holes air circulation 1 3 4 1 Hot surfaces ventilator 5 5 Humidifier 4 1 I I IATA regulations air transport of the ventilator 6 1 Ignition sources warning 4 1 Indications for Use 2 1 Indications for use 2 1 Indicator VENT STDBY 5 1 Indicator and alarm specifications A 2 Indicators AC power 6 5 INTERNAL BAT 6 2 6 5 Installation 4 1 placing the ventilator 4 1 Installation and Assembly 4 1 INTERNAL BAT indicator 6 5 Internal battery charging Warning 1 4 6 5 cover removing 6 6 maintenance none required 8 2 recharging 6 4 replacement interval 8 3 replacing 6 6 storing 6 5 test interval 8 3 testing 6 4 Internal battery replacing figure 6 6 INVERSED IE RATIO alarm message 3 11 3 19 I O switch figure 5 1 Puritan Bennett 540 Ventilator User s Manual Index K Keyboard 2 5 KEYPAD FAULT CALL SERVICE alarm message 3 11 3 19 Keys VENTILATION ON OFF 5 1 L Labels 1 13 Liqu
20. 3 15 PC Connection marking Figure 1 4 18 ESD Located inside the Device 12 30V CI I DO DO Location of DC Power Cable Connector O G O O 83 3 3 A 10 External DC Power Cable Connector Marking Figure 1 4 two 2 hours before starting ventilation See the User s Manual for more information CAUTION Portable external 115 VAC power supplies should not be used to power the ventilator unless the user that the voltage from such a power supply is within the ventilator s operating limits See the User s Manual for more information WARNING Do not connect the ventilator s power cord to an electrical outlet controlled by a wall switch 3827500 Rev A 13 Warning Caution Label Figure 1 2 Figure 1 4 16 USB Port marking Figure 1 4 ATTENTION CAUTION 100 240V 19 AC Mains Warning Located Inside the Device Note The item number callouts in the following figures refer to those listed in Table 1 2 Puritan Bennett 540 Ventilator User s Manual Safety Information Figure 1 1 Locations of Labels Top Front View Figure 1 2 Locations of Labels Front Left View 1 16 Puritan Bennett 540 Ventilator User s Manual Labels Identification and Instruction Information Figure 1 3 Location of Labels Front Right View Figure 1 4 Location of Labels and Markings Back Left View Puritan Bennett 540 Ventilator User s Manual 1 17
21. 3 s to 6 0 s for VOL A C and PRES A C 0 3 5 to 4 0 s for V SIMV and P SIMV Resolution 0 1 s Accuracy 10 Default value 1 5 s Depends on R Rate Vt Respiratory rate R Rate Range 5 bpm to 60 bpm in VOL A C and PRES 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 High Rtot Insp Time Vt Inspiratory sensitivity Insp Sens Range 1P 5 Resolution 1 Accuracy NA Default value 2 Exhalation sensitivity Exh Sens Range 5 to 95 of peak flow Resolution 5 Accuracy 4 lpm 10 of target exhalation flow based on Exh Sense Default value 25 In CPAP V SIMV and P SIMV Exh Sens is fixed at 25 and is not adjustable Ventilator Settings Cont d Puritan Bennett 540 Ventilator User s Manual A 5 Specifications Table A 11 Ventilator Range Resolution and Accuracy Continued Setting or Monitored Parameter Range Resolution and Accuracy Mode Range VOL A C PRES A C V SIMV P SIMV PSV CPAP Resolution N A Accuracy N A Default value PRES A C Flow Pattern flow pattern Range Square descending ramp Resolution N A cmH O Default value Square descending ramp In V SIMV flow pattern is set to square and is not adjustable PEEP Range OFF 0 5 cmH 0 to 20 cmH50 Resolution 1 cmH5O Accuracy 1 cm H50 10 cmH20 Default value OFF Rise time Range 1 4 Resolution 1 Default value 2 Depends on Insp tim
22. 3s Low I time Resolution 0 1 s Default value AUTO Rise time 300 ms Depends on High I time Backup R Rise time Maximum inspiratory time Range 0 8 to 3 s High I time Resolution 0 1 s Default value AUTO Min 3 s 30 R Rate Depends on Low I time R Rate Low Peak Inspiratory Pressure Range PIP 20 not adjustable Low PIP Resolution N A High Peak Inspiratory Pressure Range PIP 20 not adjustable High PIP Resolution N A Low PIP Range 2 cmH gt 0 to 52 cmH70 Resolution 1 cmH50 Default value 2 cmH30 Depends on PEEP P support High PIP High PIP Range 12 cmH gt 0 to 60 cmH O Resolution 1 cmH 0 Default value 40 cmH 0 Depends on PEEP P support Low PIP Low Inspired Tidal Volume Range 30 mL to 1990mL Low VTI Resolution 10 mL Default value OFF Depends on Vt High VTI High Inspired Tidal Volume Range 80 mL to 3000 mL High VTI Resolution 10 mL Default value 2000 mL Depends on Vt Low VTI V SIMV Mode Cont d A 8 Puritan Bennett 540 Ventilator User s Manual Range Resolution and Accuracy Table A 11 Ventilator Range Resolution and Accuracy Continued Setting or Monitored Parameter Range Resolution and Accuracy Low Exhaled Tidal Volume Range 30 mL to 1990mL Low VTE Resolution 10 mL Default value OFF Depends on Vt High VTE High Exhaled Tidal Volume Range 80 mL to 3000 mL High VTE Resolution 10 mL Default value OFF Depends on Vt
23. 4 10 mounting on a wheelchair 4 16 parts and accessories E 1 patient outlet port connections figure 4 9 potentially hot surfaces 5 5 specifications A 1 turning off 5 5 Turning on 5 1 unpacking and preparation C 1 Ventilator and liquid ingress Warning 1 3 7 1 W Warnings definition of 1 1 general list of 1 2 Warranty Preface 1 Waveforms menu 2 8 Welcome Menu screen display of 5 1 skipping 5 2 Puritan Bennett 540 Ventilator User s Manual Wheelchair mounting the ventilator onto 4 16 Index Index 5 Puritan co Bennett COVIDIEN Nellcor Puritan Bennett LLC 6135 Gunbarrel Avenue Boulder CO 80301 U S A Telephone Toll Free 1 800 255 6774 RX ony 2009 Nellcor Puritan Bennett LLC All rights reserved 10028295Rev B 0109
24. Connector Used to connect the ventilator to the nurse call system Refer to section 4 10 Mounting the Ventilator on the Utility Cart on page 4 17 USB Key connection USB functionality to allow for system upgrades Not currently used Air Inlet Filter Filters air as it enters the ventilator Figure 2 2 Back Panel Puritan Bennett 540 Ventilator User s Manual 2 7 Control Panel Control Panel PURITAN BENNETT 540 Ventilator 1 Display screen 6 Display of modes ventilation settings patient data and waveforms configuration of the ventilator and alarm management 2 Alarm indicators 7 Red indicator e High priority HP alarm activated Yellow indicator e Medium priority MP alarm activated 3 ALARM CONTROL key 8 e Press once to silence an audible alarm for 60 seconds e Press twice to halt visual and audible alarms If alarm is remedied the alarm is cancelled other than the high pressure alarm 4 UP UNFREEZE Key 9 e Moves the cursor up and increases parameter values e During ventilation reactivates waveform tracing in the Waveform menu 5 ENTER key 10 e Access to a setting value and validation of the modification of this setting e Access to a sub menu DOWN FREEZE key e Moves the cursor down and decreases parameter values e During ventilation freezes displayed waveform in the Waveform menu MENU key Changes the displayed menu From the Ventilation
25. However the battery charge status should be checked MONTHLY by disconnecting the ventilator from external power supplies refer to section 6 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 Caution Do not store the internal battery either installed within or removed from the ventilator for more than two 2 years Storage here is taken to mean a period of continuous non use 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 its 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 Service Assistance WARNING e Ifa 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 e Donot attempt to repair or otherwise service the ventilator yourself Doing so might endang
26. Low VTE Low Minute Volume Range 0 5 L to 50 L Low min vol Resolution 0 5 L Default value OFF Depends on Vt R Rate High Min vol High Minute Volume Range 2 L to 99 L High min vol Resolution 0 5 L Default value OFF Depends on Vt R Rate Low Min vol High Respiratory Rate Range 10 bom to 70 bom High Rtot Resolution 1 bpm Default value OFF Depends on R Rate Minimum inspiratory time Range RISE TIME 300ms not adjustable Low time Maximum inspiratory time Range Min 3s 30 R Rate not adjustable High time P SIMV Mode Low Inspired Tidal Volume Range 30 mL to 2000 mL Low VTI Resolution 10 mL Default value OFF Depends on High VTI High Inspired Tidal Volume Range 80 mL to 3000 mL High VTI Resolution 10 mL Default value 2000 mL Depends on Low VTI Low Exhaled Tidal Volume Range 30 mL to 1990mL Low VTE Resolution 10 mL Default value OFF Depends on High VTE High Exhaled Tidal Volume Range 80 mL to 3000 mL High VTE Resolution 10 mL Default value OFF Depends on Low VTE P SIMV Mode Cont d Puritan Bennett 540 Ventilator User s Manual A 9 Specifications Table A 11 Ventilator Range Resolution and Accuracy Continued Setting or Monitored Parameter Range Resolution and Accuracy Low Minute Volume Low Min Vol High Minute Volume High Min Vol High Respiratory Rate High Rtot Low Peak Inspiratory Pressure Low PIP High Peak Insp
27. Paused Alarm line The following graphic shows the resulting display ALARM LOG AC POWER DISCONNECTION AUG 22 06 11 21am LOW PRESSURE DISCONNECT AUG 09 06 12 24am APNEA AUG 05 06 07 14pm HIGH PRESSURE JUL 07 06 08 01pm AC POWER DISCONNECTION JULO7 06 08 24am LOW BATTERY JUN 27 06 09 24am APNEA JUN 02 06 11 20pm LOW PRESSURE DISCONNECT JUN 02 06 10 14am INVERSED E MAY 17 06 12 24pm o Reactivate Paused Alarm m Back 5 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 Analarm 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 EN disappears if it was displayed e The Alarm Paused symbol AN disappears 3 6 Puritan Bennett 540 Ventilator User s Manual 3 7 Overview of Alarms Note Overview of Alarms The message IF PERSISTS REPLACE VENT will occur only if the alarm condition continues for longer than 30 seconds Table 3 1 Overview of Alarms Alarm Message Cause Ventilator Response Cut off of the AC mains power supply Alarm activation occurs e After 5 seconds if ventilation is stopped AC POWER At the start of a ventilation DISCONNECTION cycle when ventilation is in progress Consequence switch over to external DC power supply if present otherwise to the internal battery No
28. Puritan Bennett 540 Ventilator User s Manual 6 3 Internal Battery 6 3 6 4 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 See the following graphic PRES A C O 04n00 F Control F3cmH20 M op T _OFF i A0 cmH20 Rise Time 2 NE F Rate 13 bpm 141 mL InspTime 1 s 0 0L Insp Sens 13 2 I bom qi cmH20 The LOW BATTERY and EMPTY BATTERY alarms refer to chapter 3 Alarms and Troubleshooting are triggered when the internal battery reserve is reduced WARNING e Due to its limited internal battery s reserve capacity the ventilator should only be operated occasionally while powered by its internal battery Ensure that the internal battery never becomes fully discharged e 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 ventilation may be interrupted at any time during this phase Note The EMPTY BATTERY alarm symbol may disappear shortly before the ventilator completely stops but i
29. Response Priority In VOL A C or V SIMV modes if Inspiratory Pressure is higher than High PIP during three consecutive cycles or In PSV CPAP PRES A C or P SIMV modes if Inspiratory Pressure is higher than P Support or P Control PEEP 5 cmH 0 up to 29 cmH30 or 10 cmH 0 over condition 30 cmH 0 during three becomes consecutive cycles false alarm HIGH PRESSURE or priority indicator In PSV CPAP mode and P must be Support is set to off if Inspiratory Pressure is higher manually than PEEP 10cmH20 during reset by three consecutive cycles pressing Alarm activation occurs the key e After three consecutive y breaths Consequence e Switch to exhalation phase Rate measured greater than High Rtot set during three consecutive breaths HIGH RATE Alarm activation occurs e After three consecutive breaths An Insp Time setting that results in an inspiratory time greater than the exhalation time INVERSED I E Alarm activation occurs RATIO e Upon setting parameter values such that the Insp Time value exceeds the limit described above Yes KEYPAD FAULT CALL SERVICE Keyboard key held down for more than 45 seconds IF PERSISTS REPLACE VENT Internal battery capacity LOW BATTERY lt 30min or 5 HP Yes No Expired tidal volume less than Low VTE set during three consecutive breaths in double LOW EXH VOLUME SER MP Yes No Alarm activation occurs e After three consecutiv
30. 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 fall and possibly cause damage and or personal injury N WARNING 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 Do not place the ventilator in a position where a child could 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 room temperature at the device s installed location is greater than 95 F 35 C the flow supplied at the device outlet may exceed 106 F 41 C This may lead to undesirable effects such as excessive discomfort for the patient In this case the de
31. cmH gt 0 at 30 lpm flow a Includes exhalation valve b Values obtained from the manufacturer s DAR directions for use Table A 16 Air Inlet Resistance Filter 0 057 cmH 0 5 6 pascals at 24 lpm flow a All testing conducted on 3 inch diameter test piece Table A 17 Oxygen Inlet Specifications Maximum pressure Maximum flow 7 25 psi 50 kPa 15 lpm Puritan Bennett 540 Ventilator User s Manual Manufacturer s Declaration Table A 18 Performance Specifications Working Sound pressure Maximum Internal Inspiratory pressure level pressure limit compliance triggering ventilator response time Ttr 30 dBA per NF 61 2 cmH20 0001 I cmH 0 EN ISO 17510 1 60 mbar test conditions A 9 Manufacturer s Declaration The following tables Table A 19 through Table A 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 N WARNING e Portable and mobile RF communications equipment can affect the performance of the Puritan Bennett 540 Install and use this device according to the information contained in this manual e 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 observe
32. e Inthe 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 PRES A C and VOL 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 Proximal pressure lt 0 6 cmH2O for 100 ms during inspiration phase of 2nd breath cycle Ventilator response Switch to internal pressure sensor for pressure measurement Abnormally high expired flow during the inspiratory phase of three consecutive breaths in double limb setup Alarm activation occurs After three consecutive breaths Alarm activation occurs e Systematically after software versions have changed e Loss of memorized parameters Consequence e Locking Key disabled e Out of range settings are replaced by their default values Faulty pressure valve sensor signal at ventilation start i i Yes Yes Yes Yes Puritan Bennett 540 Ventilator User s Manual Overview of Alarms Table 3 1 Overview of Alarms Continued Alarm Message Cause Ventilator Response Priority Inspired tidal volume during E Eula EXH exhalation lt 40 of Inspired VALVET Tidal volume and inspired tidal volume inspired tidal volume gt HP Yes No IF PERSISTS oe REPLACE VENT Measurement and calculation of tidal volume do not match Vt set CHK VOL INSP TIME during six consecutive breaths in SETTINGS VOL i
33. 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 Synchronous Intermittent Mandatory Ventilation SIMV A ventilator mode which provides a mechanism for synchronizing 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 Puritan Bennett 540 Ventilator User s Manual F 5 Glossary This page intentionally blank F 6 Puritan Bennett 540 Ventilator User s Manual Index A AC power connecting to 4 2 indicator 6 5 AC power cable disconnecting 4 4 holder 4 2 securing to ventilator 4 3 AC POWER DISCONNECTION alarm message 3 7 3 14 Accessories cleaning 7 2 Dual Bag 4 17 Address corporate 8 3 ADR regulations international transport of the ventilator Europe 6 1 Air circulation Warning 1 3 4 1 Air inlet filter 4 10 checking regularly Caution 8 1 replacement interval 8 2 replacing 8 1 Air inlet filter replacing figure 8 2 Air outlet antibacterial filter replacement interval 8 2 Air transport of the ventilator Warning 6 1 Alarm levels 3 1 Alarm Logs menu dismissing automatically 3 4 dismissin
34. inlet filter e bacteria filter Air Inlet Filter Consisting of foam and fine particle filter media and located at the rear of the ventilator this filter cleans the air as it enters the ventilator Refer to the figure below Puritan Bennett 540 Ventilator User s Manual 4 6 Humidifier AIR INLET DO NOT OBSTRUCT A ke o A KOM IP 31 Figure 4 10 Air Inlet Filter Caution The air inlet filter is not reusable Do not attempt to wash clean or reuse the filter Bacteria Filter It is highly recommended that you install an bacteria filter see Figure 4 11 on both single and double limb circuits In a double limb configuration two bacteria filters are used one at the port labeled TO PATIENT and the other at the port labeled FROM PATIENT e Connected to the TO PATIENT port This filter protects the ventilator from contamination by the patient primarily rebreathed air that contains a high concentration of carbon dioxide Refer to Figure 4 8 item 1 e Connected to the FROM PATIENT port This filter protects the internal expiratory flow sensor from any obstruction from the gases exhaled by the patient Refer to Figure 4 8 item 10 Figure 4 11 Bacteria Filter Refer to the manufacturer s instructions for more information about the use and maintenance of the bacteria filter s Humidifier The humidifier Figure 4 12 adds moisture water vapor and warms the air in the patient circuit It is inse
35. inspiratory trigger detected by the ventilator after the apnea time set in PSV CPAP P SIMV and V SIMV modes Automatically clears itself after two successive patient breaths Ventilator has detected an BATT FAULT1 internal battery fault CALL SERVICE Consequence the internal battery is disabled from use BATT FAULT2 No internal battery detected CALL SERVICE The internal battery is not BATT FAULT3 recognized as a CALL SERVICE Puritan Bennett battery Internal battery charging failure BATT FAULT4 Consequence charging of the REPLACE VENT internal battery impossible BATT TEMP FAULT Battery temperature out of tolerance Consequence battery charging IF PERSISTS stops REPLACE VENT Failure of one calibration point of the internal exhaled flow CAL FAULT RA SEE USER MNL Consequence failed calibration point is replaced by the default point Puritan Bennett 540 Ventilator User s Manual Yes except for CPAP Alarms and Troubleshooting Table 3 1 Overview of Alarms Continued Alarm Message CHECK PROXIMAL LINE1 IF PERSISTS REPLACE VENT CHECK PROXIMAL LINE2 IF PERSISTS REPLACE VENT CHECK CHANGE EXH VALVE2 CHECK SETTINGS CHK EXH VALV RESTART VENT IF PERSISTS REPLACE VENT Cause Ventilator Response 1 Loss of signal from the proximal pressure sensor Consequence switch to internal pressure sensor for the pressure measurement Alarm activation occurs
36. is greater Range 0s to 59 9 s Resolution 0 1 s Accuracy 50 ms or 10 whichever is greater Specifications A 7 A 8 Environmental The following environmental conditions shall be observed Table A 12 Environmental Conditions for Storage or Transport Temperature Humidity 40 F to 158 F Atmospheric 40 C to 70 C pressure 40 F to 158 F 10 to 95 RH 7 2 psi to 15 4 psi 500ft to 13 000 ft 40 C to 70 C 50 kPa to 106 kPa 152 m to 3964 m Table A 13 Environmental Conditions for Operation Temperature Humidity Atmospheric pressure 41 F to10 4 F 5 C to 40 C 10 to 95 8 7 psi to 16 0 psi 500ft to 13 000 ft RH 60 kPa to 110 kPa 152 m to 3964 m 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 113 F 45 C and humidity of 75 HR 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 Pneumatic Table A 14 Airway Resistances 1 0 cmH 0 at 30 lpm flow 0 5 cmH 0 at 30 Ipm 3 7 cmH gt 0 at 60 lpm flow 1 1 cmH 0 at 60 lpm Table A 15 Patient Circuit Resistances Adult Double Limb Pediatric Double Limb lt 2 cmH 0 at 60 lpm flow lt 2
37. kler uv4av4rrsrsarser ee 8 1 8 2 Recommended Schedule of Maintenance 0 ccc ccc cece eee eee eeeees 8 2 Oo SEMEN ITERA Tee 8 3 SDECITICATIONS accro a TT A 1 AL Ave A 1 eZ BEL ST A 1 AS gt KANG OPS and Alai sa 0 red A 2 AM POTTER A 3 P SOCCIICATIONS lt 2 44446 NR A 3 FAT TE REN sr A 3 A gt Monitored P ramelers spr trinien anaE a RTE aar eres A 4 A 6 Range Resolution and Accuracy ccc cece ete cece e TERI A 5 AZ lt EAVINOMMACIILAN dic dinero aw en A AA AONAN TSEAN Er EAA A 12 AS PHEUMAUC tcedtindeuevaedarewdancucercomastoncal ancaleusewemnsetaeeneaeccd A 12 Puritan Bennett 540 Ventilator User s Manual Contents A 9 Manufacturer s Declaration 0 ccc ccc cece ee cece eee eeeeeeeeees A 13 A 10 Standards Compliance and IEC Classification ccc cece cece cece eens A 17 B Operational Verification Checklist 0 0 B 1 C Unpacking and Preparation 0 ccc ccc ccc cece cence een eenens C 1 D ModesandBreathTypes raravananannavenrnenvenanrnrenevenrnranenene D 1 Dil Modes of Ventil tion L sagaene aker D 1 D 1 1 Assist Control A C ModeS 0 ccc cece eee cece eee e te eeenees D 1 DD SN MOE olan aE E E A N D 1 Di e HEP PAO EEE EEE EE NE EE D 1 DIA PSV CPAP Mode saja snus eenaa aaa a D 2 E Parts and Accessories aursnssarsresresaaereu ske eeehedeedasam E 1 F Glossary s F 1 NA ae re id Hd ea nd ae ee one soo Soe Index 7 Puritan B
38. manually and the cause of the alarm remains Status monitored data window e Ventilation stopped Standby displays the message PRESS C 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 patient actively triggers a breath 1 2 3 E Alarm Lag 1 2 3 Alarm Log Alarm settings Displays the specific alarm parameter values for the currently selected ventilation mode which are e Low and High alarm threshold settings and Current monitored patient readings or hyphen when ventilation is in standby Alarm message window e For Active alarms scrolls through active alarm messages in flashing reverse video For Inactive alarms displays the last alarm along with its trigger date and end of event time Refer to chapter 3 Alarms and Troubleshooting for more information Figure 2 5 Alarm Menu Alarm Menu O a TO START VENTILATION VTL 474945mL MAP BcmHi0 PEEP FemH20 FE Access line to Alarm Log menu Highlight this line and press the ENTER Q key to display the Alarm Log menu Refer to manual section 3 3 Alarm Logs Menu on page 3 3 2 7 Ventilator Overview 2 10 Waveforms Menu The display of waveforms Figure 2 6 is optional and can be selected in the using the Menu CD key refer to chapter 4 Monitored Parameter
39. of the battery may sometimes be incomplete regardless of charge time when the ambient temperature is above 104 F 40 C 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 during operation 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 about four 4 hours if the ventilator is on standby and about 10 hours if ventilation is operating N WARNING Using the ventilator on an external 12 30 VDC power source does not enable charging of its internal battery 6 5 Storing the Battery If the device is to be stored for an extended period of time it is not necessary to remove the battery However the battery should be stored in cool dry well ventilated environment as follows Puritan Bennett 540 Ventilator User s Manual 6 5 Internal Battery e Temperature approximately 70 F 21 C e Humidity less than 80 RH If the battery is stored for more than one month at a temperature greater than 70 F 21 C or for more than one or two weeks at a temperature greater than 113 F 45 C the reserve capacity of the battery may be affected It will then be necessary to recharge the battery before using it again The battery should not be stored for more than two years whatever the
40. of the device stopped immediately e 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 Speaker and battery alarms may occur when the unti is first powered on after the internal battery has been completely drained Connect to an AC power source and recycle power Table 3 3 Additional Problems and Corrective Actions No access to the Display waveform set to NO in Preference Set Display waveform to YES in waveforms menu Preference menu The screen backlight eae Backlight set to NO in Preference menu Set Backlight to YES in Preference menu witches off during ventilation Adjustment of the alarm sound level is pa sound ie incompatible with the patient s Re adjust sound level Solow orton environment Poor visibility of Contrast adjustment is incompatible Readjustcontrasi the displays with the luminosity of the environment Call your customer service representative if the problem persists CAUTION Do not expose the ventilator to direct radiation from the sun Unusual display on Problem with the display unit the screen roblem with the display unit The ventilator does not operate after pressing I O switch rere ens Replace the ventilator and call your gn NOISE l customer service representative Filter and or turbine silencer Replace the ventilator and call your Whistling noise or deteriorated customer service re
41. 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 AN 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 a If exhaled volume monitoring is required use the double limb circuit for exhaled tidal volume or minutes volume monitoring Figure 2 1 Front Panel Puritan Bennett 540 Ventilator User s Manual 2 3 Ventilator Overview 2 6 Back Panel 11 1 Ergonomic carrying handle 2 On Off I O switch with protective cover Device powered on in position I device switched off in position 0 3 AC power Mains cable connector 4 AC power Mains cable holding system Prevents accidental disconnection of the AC power cable 5 Access cover for the internal battery 6 DC power cable connector with key 10 11 PC Cable Connector USB mini B connector used for Puritan Bennett Ventilator Test Software O Inlet Port Connects the ventilator to a low pressure oxygen source via an adaptor connected to the Oj Inlet refer to section 4 8 Oxygen on page 4 13 Nurse Call Output
42. 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 and so on must be as low as possible Settings particularly the LOW PRESSURE DISCONNECT 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 e To ensure proper performance of the ventilator use a patient circuit recommended by Puritan Bennett in this manual refer to chapter 4 Installation and Assembly The total specified length of the patient circuit tubing as measured from the ventilator outlet to the ventilator inlet is 3 6 feet 1 10 meters to 6 6 feet 2 00 meters 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 When using non invasive ventilation niv use a non vented nose or face mask e Before using the Nurse Call system ensure that its conne
43. representative Adjustment of the Low Min Vol level too Under the guidance of a Clinician modify high the Low Min Vol level nappropriate patient circuit appropriate one LOW MINUTE VOLUME Patient circuit obstructed or disconnected Cen URDOCY ANOOI prepely one the patient circuit Have a qualified technician replace the defective component s and call your customer service representative i Under the guidance of a Clinician Me ORLON PIOR decrease the Low PIP threshold Check the patient circuit connections to Leak or loose connection in the patient the ventilator examine all connections for circuit leakage and tightness LOW INSP VOLUME Defective flow sensor or internal leak in the machine Defective flow sensor or internal leak of the machine LOW PRESSURE DISCONNECT Replace the patient circuit if necessary VENT Inappropriate patient circuit Replace the patient circuit Have a qualified technician replace the defective component s and call your customer service representative IF PERSISTS REPLACE Defective internal circuits of the machine or pressure sensor OCCLUSION CHECK CIRCUIT Clean unblock and or properly connect Patient circuit obstructed the patient circuit IF PERSISTS REPLACE VENT Cancel the alarm then check the supply re pe alae PPY CUT OWEN wiring and or the effective availability of there is no AC mains power supply ON INTERNAL BATTERY v
44. 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 Puritan Bennett 540 Ventilator User s Manual C 1 Unpacking and Preparation WARNING 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 Puritan Bennett 5 Clean the ventilator with a mild soap solution if necessary refer to chapter 7 Cleaning 6 Ensure that the air inlet filter is installed Figure C 1 Puritan Bennett 540 Portable Ventilator C 2 Puritan Bennett 540 Ventilator User s Manual Puritan Bennett 540 Ventilator User s Manual Figure C 2 Dual Bag Unpacking and Preparation C 4 This page intentionally blank Puritan Bennett 540 Ventilator User s Manual D 1 D Modes and Breath Types Modes of Ventilation This chapter is a general description of the various modes of ventilation and breath types available with the Puritan Bennett 540 Ventilator Note The default ventilation mode setting is PRES A C for more information see below D 1 1 Assist Control A C Modes When set to an Assist Control mode machine initiated breaths are delivered at a clinician set volume
45. the patient circuit connections Replace the patient circuit with an appropriate one Have a qualified technician replace the defective component s and call your customer service representative Under the guidance of a Clinician increase the High PIP threshold Check patient s trachea and clear the obstruction If the filter is obstructed Proximal pressure tube or patient circuit obstructed Coughing or other high flow expiratory efforts Patient inspiratory resistance or compliance changes Defective internal circuits of the machine or pressure sensor HIGH PRESSURE replace the filter Clean the proximal pressure tube or the patient circuit or replace them e Silence the alarm if necessary e Treat patient s cough Have physician determine new ventilator settings Replace the ventilator and call your customer service representative Puritan Bennett 540 Ventilator User s Manual Troubleshooting Table 3 2 Alarms and Corrective Actions Continued Meme Jer Possible Reason s For The Alarm Event Corrective Action s Symptom Under the guidance of a Clinician re Adjustment of the High Rtot level too low adjust High Rtot Adjustment of the Insp Sens level too low CnaT IE guidance m inican aes Insp Sens according to the patient HIGH RATE es Silence the alarm and call for a medical Patient s hyperventilation team if the symptoms persist Have a qualified technician replace the
46. to malfunction The alarms or faults generated by your Puritan Bennett 540 Ventilator are classified into two categories e Ventilation or utilization alarms e Technical faults Some of the ventilator alarms are adjustable depending on ventilation modes refer to chapter 3 Operating Parameters Automatic unadjustable alarms also exist to create a safety net for safe patient ventilation Alarms indicate events likely to affect the ventilation in the short term and necessitate rapid intervention refer to section 3 8 Troubleshooting on page 3 14 Technical faults do not directly affect machine operation Therefore the user is not alerted to technical faults Only authorized and trained technicians may consult the maintenance menu refer to the Puritan Bennett 540 Service Manual Note Default alarm setting preferences should be entered prior to using the ventilator 3 1 Alarm Level of Priority The alarm hierarchy for signaling 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 Frequency Sou
47. visual alarm message Apnea The absence of breathing or a breathing pattern capable of supporting an individual s respiratory needs 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 EN 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 540 Ventilator User s Manual F 1 Glossary F 2 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 The total number of breaths both machine and spontaneous delivered by a ventilator in one minut
48. 3 VTI min ml vam ma na ao sso 250 so wa na VTI min ml m te na ona vo rao so 70 wa Note NA in Table A 9 indicates data not applicable to the patient groups tested represented by designators a and R Monitored Parameters Table A 10 Monitored Parameter Specifications and Tolerances Expiratory Minute Volume Min VE 0 to 99 9 20ml 20 in CPAP mode above 200ml a The PB 540 does not have the capability to reduce pressure below the PEEP pressure during the expiratory phase Puritan Bennett 540 Ventilator User s Manual Range Resolution and Accuracy A 6 Range Resolution and Accuracy Table A 11 lists the ranges resolutions and accuracies for ventilator settings alarm settings and patient data Table A 11 Ventilator Range Resolution and Accuracy Setting or Monitored Parameter Range Resolution and Accuracy Ventilator Settings 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 Pressure control Range 5 cmH gt 0 to 55 cmH gt 0 P Control Resolution 1 cmH5O Accuracy 1 cmH 0 10 of P Control PEEP setting Default value 15 cmH zO0 Pressure support Range OFF or 5 cmH gt 0 to 55 cmH gt 0 P Support Resolution 1 cmH O Accuracy 1 cmH gt 0 10 of P Support PEEP setting Default value 15 cmH5 0 Inspiratory time Insp Time Range 0
49. A TA KEDI Babe coniun K Q E single patient IP31 use only 5 Exhalation Limb 6 Air Inlet Label 7 Exhaled Gas Outlet Label Connection of Patient Circuit l i eee Single Use Exhalation Block Figure 1 4 Figure 1 2 Figure 1 4 Label Figure 1 1 Figure 1 2 Figure 1 5 1 14 Puritan Bennett 540 Ventilator User s Manual Labels Identification and Instruction Information Table 1 2 Ventilator Labels and Markings Continued PURITAN BENNETT 540 Ventilator ade Tyco Healthcare Group LP 70 C Nellcor Puritan Bennett LLC 6135 Gunbarrel Avenue Boulder CO 80301 USA 40 C Made in Ireland STORAGE 3831700 Rev A 8 Identification Label Figure 1 5 11 Direction of Installation of Internal Battery Label Figure 1 5 14 See Instructions For Use Label Figure 1 5 17 Nurse Call Cable Connector Marking Figure 1 4 Location of AC Power Cable Connector 100 240V 50 60 Hz EO YA 9 AC Power Mains Cable Connector Marking Figure 1 4 WARNING Federal 3827500 Rev A WARNING Electrical shock hazard Service should performed by qualified personnel only WARNING Risk of explosion if used in the presence of flammable anesthetics WARNING Disconnect power cord and remove battery before servicing the ventilator This device in whole or in part may be protected by one or more U S or foreign patents or patent applications 3827500 Rev A 12 Warning Caution Label Figure 1
50. ANGE EXH VALVE1 alarm message 3 8 3 9 3 16 CHECK CHANGE EXH VALVE2 alarm message 3 8 CHK EXH VALV RESTART VENT alarm message 3 8 3 16 CHK VOL INSP TIME SETTINGS alarm message 3 9 3 17 Classification of device 2 2 Cleaning Index 2 Accessories 7 2 ventilator 7 1 Cleaning solutions and products approved 7 1 Connecting the oxygen supply 4 14 Connecting to AC power 4 2 DC power 4 5 oxygen 4 14 oxygen supply figure 4 15 Consumables replacement intervals 8 2 Contraindications against use of ventilator 2 1 D Dangerous Goods Classification 6 I DC power connecting to 4 5 DC power cable connecting to ventilator 4 6 disconnecting from ventilator 4 6 Device classification 2 2 DEVICE FAULT1 REPLACE VENT alarm message 3 9 3 17 DEVICE FAULT2 REPLACE VENT alarm message 3 9 3 17 DEVICE FAULT3 REPLACE VENT alarm message 3 9 3 17 DEVICE FAULT4 REPLACE VENT alarm message 3 9 3 17 DEVICE FAULT5 REPLACE VENT alarm message 3 9 3 17 DEVICE FAULT6 REPLACE VENT alarm message 3 9 3 17 DEVICE FAULT7 REPLACE VENT alarm message 3 9 3 17 Display of alarms 3 2 Dual bag accessory 4 17 Dual Bag figure 4 17 C 3 E Electrical specifications A 1 Electromagnetic compatibility and mobile portable communications equipment 4 2 Electromagnetic emissions and use of accessories 4 2 EMPTY BATTERY alarm message 3 10 3 17 6 4 Environment suitable for use of ventilator 2 1 Environmental specifications A 12 Exhalation block 4
51. Defective inspiratory flow sensor defective component s and call your customer service representative Decrease the adjustment threshold of Insp Time INVERSED Adjusted Insp Time inducing an inspiratory A N WARNING I E RATIO time higher than the expiratory time P a g P y Ensure the Insp Time setting is compatible with the physiological requirements of the patient Press and release keys in the normal Pressing a key for more than 45 seconds prescribed manner Do not press keys for KEYPAD FAULT CALL SERVICE 45 seconds or more Attempt to activate each key If unsuccessful in releasing the stuck key s A key on the keyboard is stuck replace the device and call your customer service representative if the situation persists Adjustment of a Low VTE threshold when A WARNING Immediately connect the ventilator to an i avis h AC power outlet or connect it to an Interna battery capacity is less than external DC power source LOW BATTERY 30 min or 5 battery operation over aviended Reminder the internal battery can be charged only when the ventilator is connected to an AC power supply the patient circuit is in a single limb If exhaled volume monitoring is Patient circuit obstructed Cean meer ander prepeny connect the patient circuit Leak in the patient circuit Check and properly connect the patient circuit connections Exhalation block missing or disconnected ean me EP Me or clinician configu
52. E VENT DEVICE FAULT12 REPLACE VENT EMPTY BATTERY EXHSENS FAULT OR CRKT LEAK HIGH DEVICE TEMP COOL VENT IF PERSISTS REPLACE VENT HIGH EXH VOLUME HIGH INSP VOLUME HIGH MINUTE VOLUME Cause Ventilator Response POST RAM Error RAM Read Write does not match 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 Internal battery capacity lt 10 min or 2 battery voltage lt 22 5V Consequence ventilation comes to a halt At least four of the last six spontaneous breaths are terminated by time Device internal ambient temperature out of tolerance range Expired tidal volume greater than High VTE set during three consecutive breaths in double limb setup Alarm activation occurs e After three consecutive breaths Inspired tidal volume greater than High VTI set during three consecutive breaths in PSV CPAP PRES A C P SIMV and V SIMV modes Alarm activation occurs e After three consecutive breaths Minute volume higher than High MinVol set during three consecutive breaths Alarm activation occurs e After three consecutive breaths Puritan Bennett 540 Ventilator User s Manual Overview of Alarms Table 3 1 Overview of Alarms Continued Alarm Message Cause Ventilator
53. Install the bacteria filter item 1 on the TO PATIENT 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 and the inlet ports of the exhalation valve item 5 Ensure the exhalation valve item 5 is placed at the level of the patient Connect one end of the proximal pressure tubing item 6 to the proximal pressure port on the exhalation valve item 5 and the other end onto the ventilator patient pressure port item 8 Connect one end of the exhalation valve tubing item 7 to the exhalation valve port on the exhalation valve item 5 and the other end onto the ventilator exhalation valve port item 9 Puritan Bennett 540 Ventilator User s Manual 4 7 Installation and Assembly NOTE Although shown here the humidifier item 2 water trap er item 3 and tubes upstream of 10 the single limb patient circuit are not included with the ventilator Contact your supplier for more information DN N 7 de aA See also Figure 4 9 6 me on page 4 9 J Figure 4 7 Single Limb Patient Circuit 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 ite
54. Performance Specifications sassseess iver seede eee A 13 FIECEFOMAGNE EG EMISSIONS anse des A 13 Electromagnetic Immunity 6 ccc ccc ee eee tence eee ee eee eeeeneeeeees A 14 Electromagnetic Immunity Conducted and Radiated RF 0ceee eens A 15 Recommended Separation Distances 0 c cece cece cece eee cee eeeeeeees A 16 Compliant Cables and Accessories 0 cece cece cece teen ene e ee eeeeeees A 16 Operational Verification Checklist 0 0 0 0 0 c ccc ccc ccc ccc ccc cece teen eeeees B 1 List of Consumables and Accessories ccc eect eee e eee eeeeeeees E 1 NNN E 2 Puritan Bennett 540 Ventilator User s Manual ix This page intentionally blank Preface Purpose of This Manual This manual contains important information regarding the safe operation of your Puritan Bennett 540 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 Chapter 1 Safety Information Qualification of Personnel Installation and maintenance of the device must be made by authorized and trained personnel In particular training for the handling of products sensitive to electrostatic discharges must include the
55. Puritan Bennett 540 Ventilator oe PURITAN BENNETT 540 Ventilator nP AUDIO PAUSED 442 Pang ER HI ALARM PAUSED ALARM RESET FOUOW INSTRUCTIONS FOR USE VENT sro ay VENTHATION ON Orr User s Manual COVIDIEN Copyright information Copyright 2009 Nellcor Puritan Bennett LLC All rights reserved Puritan Bennett 540 is a trademark of Nellcor Puritan Bennett LLC and or its affiliates COVIDIEN COVIDIEN with Logo and marked brands are trademarks of Covidien AG or an affiliate The information contained in this manual is the sole property of Nellcor Puritan Bennett LLC and may not be duplicated without permission This manual may be revised or replaced by Nellcor Puritan Bennett LLC at any time and without notice You should ensure that you have the most current applicable version of this manual if in doubt contact Puritan Bennett s Technical Support department or visit the Puritan Bennett product manual web page at http www puritanbennett com serv manuals aspx While the information set forth herein is believed to be accurate it is not a substitute for the exercise of professional judgment The ventilator should be operated and serviced only by trained professionals Nellcor Puritan Bennett LLC s sole responsibility with respect to the ventilator and its use is as stated in the limited warranty provided Nothing in this manual shall limit or restrict in any way Nellc
56. V CPAP PRES A C and P SIMV modes Alarm activation occurs e After three consecutive breaths Cut off of the external DC power supply Consequence switch over to the internal battery l l Yes Yes l Yes Yes Puritan Bennett 540 Ventilator User s Manual Table 3 1 Overview of Alarms Continued Alarm Message POWER FAULT REPLACE VENT POWER SUPPLY LOSS no message REMOTE ALARM FAULT SOFTWARE VERSION ERROR SPKR FAULT 1 REPLACE VENT SPKR FAULT2 REPLACE VENT SPKR FAULT3 REPLACE VENT SPKR FAULT4 REPLACE VENT Cause Ventilator Response Detection of a fault in the 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 it was the only source of power 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 No activation of Nurse Call when an alarm is in progress Detection of a wrong software version Defective operation of the buzzers Consequence no audible tone when an alarm is activated Failure detected in the Very High Priority buzzer Consequence no audible alarm in case of involuntary stop of the ventilation Battery Charge Failure due to incorrect voltage Contact your servi
57. 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 3 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 Oxygen Enrichment Oxygen may be supplied from an external low pressure source but the oxygen flow must be limited to 15 lpm at 7 25 psi 50 kPa The ventilator automatically compensates for the extra flow created by the external oxygen supply refer to chapter 4 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 or minutes volume monitoring For more information refer to section 4 4 Patient Circuit on page 4 6 Note It is highly recommended that users always possess an additional breathing circuit and valve while using the Puritan Bennett 540 Ventilator Device Classification The ventilators IEC 60601 1classification is as follows e Protection Insulation class e
58. alarms for 60 seconds at a time cancel an alarm For more information refer to section 3 Alarms and Troubleshooting This symbol appears on the ventilator s front panel MENU key see Figure 2 3 on page 2 5 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 5 item 8 This key is used to Start and Stop ventilation Air outlet towards patient This symbol appears on the front right of the ventilator adjacent to the TO PATIENT port see Figure 1 3 item 2 and Figure 4 9 on page 4 9 Air return from patient double limb option This symbol appears on the front left of the ventilator adjacent to the From Patient port see Figure 1 2 item 5 Patient proximal pressure port This symbol appears on the front right of the ventilator adjacent to the From Patient port see Figure 1 1 item 4 and Figure 4 9 on page 4 9 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 item 4 and Figure 4 9 on page 4 9 Oxygen inlet This marking appears on the back panel of the ventilator adjacent to the oxygen inlet port see Figure 1 4 item 3 and Figure 4 14 on page 4 14 Puritan Benne
59. arm Log If several alarms are activated at the same time pressing the ALARM CONTROL key affects all current alarms Puritan Bennett 540 Ventilator User s Manual Resetting Pausing Alarms The audible portion of activated alarms is automatically reactivated 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 3 5 Resetting Pausing Alarms N WARNING e 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 e 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 ceases these 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 the audible portion light indicator and message are all halted for the alarms which can be paused manually e The Alarm Paused ZX symbol is displayed at the top r
60. assification and regulatory requirements may vary depending upon the country and mode of transport In addition air transport of the Puritan Bennett 540 Ventilator is only allowed as carry on baggage which may include up to two 2 individually packaged spare Lithium ion batteries it is recommended that users verify specific requirements limitations with the airline carriers as to which measures to take before the voyage e To minimize the risk of damage you must use the ventilator Dual Bag to transport the ventilator e The ventilator should never be immersed in any liquid and any liquid on the surface of the device should be wiped away immediately e To avoid damage to the ventilator 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 installed and operated in the environmental conditions recommended in Appendix A Specifications 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 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 c
61. ator User s Manual Connecting to External AC Power To secure the AC power cable proceed as follows 1 Insert the power cable holder Figure 4 2 item 1 into the notch of the battery cover GE KRG SN af IV JEG Figure 4 2 Inserting the Power Cable Holder Into the Notch 2 Push the AC power cable into the power cable holder Figure 4 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 HF HdA md Figure 4 3 Power Cable Connected to the Ventilator 4 Connect the male end of the AC power cable to the AC power outlet e The ACPOWER NUY indicator on the top left corner of the ventilator illuminates The INTERNAL BAT indicator flashes while the battery charges and then turns off when the battery is fully charged Refer to Figure 4 4 on page 4 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 4 4 Note The only time the AC POWER and INTERNAL BAT indicators are illuminated at the same time is when the
62. call your ALERT any other technical anomaly customer service representative APNEA Patient s breathing effort less than the Sensitivity control setting Under the guidance of a Clinician adjust the Insp Sens setting that which is appropriate for the patient Examine the patient for breathing effort Patient apnea l and stimulate if necessary Defective sensors Have a qualified technician replace the defective component s and call your customer service representative BATT FAULT1 Battery problem that prevents it from Replace the ventilator and call your CALL SERVICE operating customer service representative BATT FAULT2 ae Replace the ventilator and call your CALL SERVICE Internal battery missing or not detected BATT FAULT3 Internal battery not recognized as a i CALL SERVICE Puritan Bennett battery Call your customer service representative BATT FAULT4 REPLACE VENT Battery charging impossible Puritan Bennett 540 Ventilator User s Manual Do not disconnect the ventilator from the AC power supply Ensure that the power cable is installed according to the instructions in chapter 4 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 Alarms and Troubleshooting Table 3 2 Alarms and Corrective Action
63. ce representative e Call your customer service representative e Connect the ventilator to its AC power supply Ensure that the internal battery SPKR FAULT1 SPKR is completely charged FAULT2 Internal technical problem that prevents REPLACE VENT the very high priority POWER SUPPLY e Ensure that the protective cover over LOSS alarm from triggering 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 e Ensure that the device is stabilized Replace the ventilator and call your customer service representative SPKR FAULT3 REPL ACE VENT Internal technical problem that prevents the battery from correctly charging SPKR FAULT4 Internal technical problem that prevents Replace the ventilator and call your REPLACE VENT the battery warning buzzer from operating customer service representative 3 8 2 Other Problems Table 3 3 provides other possible ventilator problems causes and corrective actions Puritan Bennett 540 Ventilator User s Manual 3 21 Alarms and Troubleshooting 3 22 N WARNING e Ifthe 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 odor alarms not triggered during the start up procedure the oxygen and power supplies should be disconnected and use
64. ce representative for assistance Buzzer Battery Failure The Battery Buzzer Voltage is too low disabling the buzzer Contact your service representative for assistance Puritan Bennett 540 Ventilator User s Manual Overview of Alarms Alarms and Troubleshooting 3 8 Troubleshooting Caution e This manual tells you how to respond to ventilator alarms but it does NOT tell you how to respond to the patient e To ensure proper servicing of the ventilator and reduce the possibility of physical injury only qualified personnel should attempt to service the Puritan Bennett 540 Ventilator 3 8 1 Alarms WARNING 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 Table 3 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 cleaning the device 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 Table 3 2 Alarms and Corrective Actions Alarm Message or Possible Reason s For The Alarm Event Corrective Action s Symptom Cancel the alarm then check the suppl
65. conditions 6 6 Replacing the Battery N WARNING e The ventilator must be disconnected from all external power supplies and be turned off during this operation e Batteries should be disposed of according to environmental legislation in your country and locality e Never expose any batteries to direct flame e Never touch the ventilator s internal components including the battery and the patient simultaneously To replace the Battery refer to Figure 6 3 and proceed as follows 1 Place the ventilator on a work table 2 Remove the three 3 screws Figure 6 3 item 1 securing the battery cover with a Torx T10 screwdriver These screws consist of two 2 Torx head screws on the rear panel and one 1 Torx head screw on the bottom of the ventilator as shown depending on the version of the device Torx Head Screw Figure 6 3 Replacing the Battery 3 Slide the battery cover Figure 6 3 item 2 off by pulling it towards the back of the ventilator 4 Remove the old battery Figure 6 3 item 3 from the battery cover 5 Remove the replacement battery from its package and install it into the battery cover Ensure that e You remove the protective pull tabs if they are present from the battery s contacts e The battery s contacts align with those of the ventilator according to the drawing on the label on the back of the battery cover Puritan Bennett 540 Ventilator User s Manual Replacing the Battery
66. ctions are secure and it operates properly For more information contact Puritan Bennett Puritan Bennett 540 Ventilator User s Manual 1 5 Safety Information 1 6 Precautions Regarding Settings N WARNING J 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 Do not allow a patient to remain connected to the ventilator when ventilation is stopped because a substantial quantity of expiratory 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 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 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 I
67. cy 99 54 at 24 lpm filtering microbes 2 5 um to 3 um Inspiratory Bacteria Filter Maximum allowable flow resistance 4cmH20 at Requirement 60 Ipm Electrical Table A 2 AC Electrical Supply 100 VAC to 240 VAC 50 Hz 60 Hz 180 VA max Puritan Bennett 540 Ventilator User s Manual Specifications A 3 Table A 3 Internal Lithium lon Battery Ampere hour rating Charging current e Standby mode 1 5 A hr duration lt 6 hr e Ventilation mode 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 Vt 200 ml 5 ml PIP 10 cmH30 2 cmH gt 0 Rtot 20 bpm 11 hr 10 Vt 300 ml 5 ml PIP 20 cmH30 2 cmH 0 Rtot 15 bom 9 hr 10 Vt 500 ml 5 ml PIP 30 cmH30 2 cmH gt 0 Rtot 15 bpm 6 5 hr 10 Vt 750 ml 5 ml PIP 45 cmH30 2 cmH gt 0 Rtot 20 bpm 4 5 hr 10 maximum settings Table A 4 Remote Alarm Remote Alarm Port Also known as the Nurse s Call port it provides for remote alerts of ventilator alarm conditions An example 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 oe 1 relay common black condition occurs unless either o
68. d 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 A Specifications 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 Due to its limited internal battery s reserve capacity the ventilator should only be operated occasionally while powered by its internal battery 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 Even if the INTERNAL BAT indicator is off charge of the battery may sometimes be incomplete regardless of charge time when the ambient temperature is above 104 F 40 C This is due to the characteristics 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 When replacing the ventilator s internal battery the ventilator must be disconnected from all external power supplies and turne
69. d off Batteries should be disposed of according to environmental legislation in your country and locality Never expose any batteries to direct flame Never touch the ventilator s internal components including the battery and the patient simultaneously Puritan Bennett 540 Ventilator User s Manual Warnings N WARNING Hoses and Accessories e The ventilator must not use nor be connected to any anti static or electrically conductive hoses tubing or conduits High and Low VTE alarm parameters must be properly set to warn in the event of patient suffocation e During invasive ventilation when an artificial airway bypasses the patient s upper respiratory system the patient s upper respiratory system cannot humidify the incoming air For this reason the use of a humidifier to minimize drying of the patient s airways and subsequent irritation and discomfort must be used e If exhaled tidal volume or exhaled minute 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 High and Low VTE alarm parameters must be properly set to warn in the event of patient suffocation e The patient circuit should always be positioned to avoid hindering the patient s movements to prevent accidental disconnection and to minimize the risk of patient strangulation e For pediatric use ensure that the patient circuit t
70. d to verify normal operation in the configurations in which it will be used Table A 19 Electromagnetic Emissions The Puritan Bennett 540 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 RF emissions The ventilator uses RF energy only for CISPR 11 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 establishments including domestic a establishments and those directly pasion SON Class A connected to the public low voltage IEC 61000 3 2 power supply network that supplies Voltage fluctuations Complies buildings used for domestic flicker emissions purposes IEC 61000 3 3 Puritan Bennett 540 Ventilator User s Manual A 13 Specifications Table A 20 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 60601 1 2 Test Level Compliance Level Environment Guidance Electrostatic discharge ESD IEC 61000 4 2 Electrical fast transient burst IEC 61000 4 4 Surge IEC 61000 4 5 Voltage dips short interruptions and voltage variations on
71. dio 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 applicable RF compliance level above the Legendair XL2 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 540 d Over the frequency range 150 kHz to 80 MHz field strengths should be less than 10 V m Table A 22 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 Rated Maximum Output Power of Transmitter W outside ISM bands in ISM bands d 0 35 P d 1 2 P d 1 2 P d 2 3 P For transmitters rated at a maximum output power not listed above the recommended se
72. e 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 0O An abbreviation for centimeters of water which is a unit of measure for pressure Continuous Positive Airway Pressure CPAP Continuous airway pressure maintained throughout a spontaneous breath cycle Controlled breath A volume or pressure breath triggered controlled and terminated by the ventilator 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 expiratory block for expiratory 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 Expiratory minute volume Min VE Volume exhaled by the patient at each expiratory phase and multiplied times the respiratory rate Exhalation sensitivity The exhalation sensitivity Exh Sens level is a percentage of peak flow at which a pressure supported breath will be terminated Expiratory Tidal Volume VTI V
73. e 22 mm for adults and a ringed tube 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 circuit and valve while using the Puritan Bennett 540 Ventilator 4 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 4 4 2 Installing the Patient Circuit The patient circuit is mounted depending on the setup of the circuit used and the accessories used 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 do the following and refer to Figure 4 7 1 a eo 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
74. e In P SIMV and V SIMV rise time is set to 2 and is not adjustable Backup rate Range 5 40 bom Resolution 1 bpm Default value 13 Depends on Min Insp time In P SIMV and V SIMV Backup rate Max 8 R Rate Apnea time Range AUTO or 1 60 s Resolution 1 s Default value AUTO Depends on Backup R In PSV Apnea time AUTO 60 Backup R s or Apnea time AUTO 30s In V SIMV or P SIMV Apnea Time AUTO 12 Alarm settings based on breath mode Pressure A C Mode Low Inspired Tidal Volume Range 30 mL to 1990mL Low VTI Resolution 10 mL Default value 300 Depends on High VTI High Inspired Tidal Volume Range 80 mL to 3000 mL High VTI Resolution 10 mL Default value 2000 mL Depends on Low VTI Pressure A C Mode Cont d A 6 Puritan Bennett 540 Ventilator User s Manual Range Resolution and Accuracy Table A 11 Ventilator Range Resolution and Accuracy Continued Setting or Monitored Parameter Range Resolution and Accuracy Low Exhaled Tidal Volume Low VTE High Exhaled Tidal Volume High VTE Low Minute Volume Low Min Vol High Minute Volume High Min Vol High Respiratory Rate High Rtot Low Peak Inspiratory Pressure High Peak Inspiratory Pressure PSV CPAP Mode Low inspired tidal volume Low VTI High inspired tidal volume High VTI Low exhaled tidal volume Low VTE High exhaled tidal volume High VTE PSV CPAP Mode Cont d Puritan Bennett 540 Ventila
75. e breaths Puritan Bennett 540 Ventilator User s Manual 3 11 Alarms and Troubleshooting Table 3 1 Overview of Alarms Continued Alarm Message LOW INSP VOLUME LOW MINUTE VOLUME LOW PRESSURE DISCONNECT IF PERSISTS REPLACE VENT LOW SPKR BATTERY OCCLUSION CHECK CIRCUIT IF PERSISTS REPLACE VENT ON INTERNAL BATTERY with Periodic Audible Signal Cause Ventilator Response Inspired tidal volume less than Low VTI set during three consecutive breaths in PSV CPAP PRES A C P SIMV and V SIMV modes Alarm activation occurs e After three consecutive breaths Minute volume lower than Low Min Vol set during three consecutive breaths Alarm activation occurs e After three consecutive breaths If the flow is greater than 130 lpm during the inspiratory phase or In VOL A C and V SIMV modes if patient pressure is lower than Low PIP or In PSV CPAP PRES A C modes and P SIMV if patient pressure is lower than P Support PEEP 20 or P Control PEEP 20 Alarm activation occurs If one of these three conditions remains for more than 15 seconds or the maximum time between 15 seconds and Apnea Time 2 seconds Occurs when the buzzer battery is too low to sound an alarm when ventilating using battery power Connecting the ventilator to AC power for 15 minutes should clear the alarm Tidal volume measured negligible during three consecutive breaths for PS
76. e CPAP mode PSV CPAP mode maintains a constant level of pressure in the patient s airway In addition the ventilator 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 air into his or her lungs D 2 Puritan Bennett 540 Ventilator User s Manual E Parts and Accessories Table E 1 provides a list of accessories that are available for the Puritan Bennett 540 Ventilator To order parts or accessories contact your equipment supplier or Puritan Bennett representative Note The ventilator is shipped from the factory 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 dual bag one O connector and one AC power cable US version Table E 1 List of Consumables and Accessories Description Carrying bag grey Oxygen inlet connector Carrying belt Suspension belt Backpack Padded Straps Remote Alarm Box and Cable Ventilator Cart Dual Bag delivered with Backpack Padded Straps 2 ea Suspension belt Carrying belt WARNING To minimize the risk of damage you must use the ventilator Dual Bag to transport the ventilator AC mains power cable DC power cable for connection to an external DC power source such as a car c
77. e and should be replaced periodically The exhalation date may be located on the back of the hose end piece The oxygen supply must be regulated using a flow meter connected to the source gas outlet 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 Precautions Regarding Electromagnetic Interference Caution The Puritan Bennett 540 requires special precautions for electromagnetic compatibility and should be installed and started according to the recommendations found in Appendix A 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 A 9 Manufacturer s Declaration in the Clinician s Manual The use of any accessory other than those specified with the exception of the power supplies or cables sold by Puritan Bennett 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 1 4 Symbols and Markings Table 1 1 Ventilator Symbol
78. e cable disconnection or a total loss of power Ensure that the Nurse Call device is always connected to the ventilator Caution Hoses and Accessories e Before opening the packaging for the Patient Circuit ensure that no damage is evident to the packaging or its contents If evidence of damage exists contact your supplier Maintenance Precautions Caution e Before cleaning the ventilator first disconnect the ventilator and the circuit e 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 e 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 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 Failing to replace a dirty air inlet filter or operating the ventilator without a filter may cause serious damage to the ventilator e Except for changing the battery as required by qualified technicians or the Clinician do not attempt to open the ventilator s enclosure Doing so might result in damage to the device and or may void your warranty Puritan Bennett 540 Ventilator User s Manual 1 9 Safety Information Precautions Regarding Oxygen Caution The oxygen supply hose ages even when it is not in us
79. e 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 540 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 and 1 3 Cautions as well as all warnings and cautions contained throughout this manual Puritan Bennett 540 Ventilator User s Manual 1 1 Safety Information 1 2 Warnings 1 2 General Precautions For Use N WARNING e Federal law restricts this device to sale by or on the order of a licensed physician The ventilator must be used only under the responsibility and on the prescription of a doctor The ventilator must be used according to its intended use Refer to section 2 1 Indications for Use Be aware this manual describes how to respond to ventilator alarms but it does NOT tell you how to respond to the patient 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 To ensure that ventilation continues uni
80. ector s black O ring item 2 is not missing 2 Push the oxygen supply s oxygen connector item 1 into the ventilator s oxygen connector Figure 4 15 item 3 e the ventilator s oxygen connector s locking stud item 4 retracts e the ventilator s oxygen connector s locking tab item 5 is released ensuring that the oxygen connection is locked and secured in place Figure 4 15 Connecting the Oxygen Supply System To disconnect the oxygen supply system from the ventilator proceed as follows 1 Stop the oxygen flow from the oxygen supply 2 Press the locking tab of the ventilator s oxygen connector as shown in Figure 4 16 to unlock the oxygen connection Figure 4 16 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 4 15 item 2 will then extend outwards which is required before the oxygen connector can be reconnected Puritan Bennett 540 Ventilator User s Manual 4 15 Installation and Assembly 4 9 N WARNING J Never use the ventilator with an unregulated unadjustable oxygen source The connecting hose between the ventilator and the O source must be designed for use exclusively with medical grade oxygen Under no circumstances should this hose be modified by the user and it must be installed without the use of lubricants Disconnect the oxygen supply s oxygen connector
81. educe 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 7 Cleaning e When replacing the ventilator s internal battery the ventilator must be disconnected from all external power supplies and turned off e Never touch the ventilator s internal components including the battery and the patient simultaneously 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 section 10 Routine Maintenance in the Clinician s Manual This is particularly important when the ventilator is installed on a wheelchair because environmental conditions may cause the filter to become dirty more rapidly Puritan Bennett 540 Ventilator User s Manual 1 7 Safety Information N WARNING Maintenance Precautions Cont d 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 emi
82. eeeeees 4 14 4 9 Mounting the Ventilator on a Wheelchair 0 cc cece eee e eee eens 4 16 4 10 Mounting the Ventilator on the Utility Cart 0 ccc eee eee eens 4 17 4 11 Connecting the Nurse Call Cable ccc ccc cece eee eee enes 4 18 Operating Procedures a aanaananannvnannvnannvnennenennenenneneeneneee 5 1 5 1 Turning on The Ventilator 0 ccc cee cece eee e eee e eee eeeeaeannes 5 1 5 2 Starting Ventilation sesia ase Gere GT dekan 5 2 535 StOPDING VENTIAUOM 10 5 60 2uieweb bewe bene ks abd eke eh ce tale EG Ne 5 4 54 Turning Off the Ventilator ss sessed adcat nda dwidinitindadiaiaddwiatiae ea 5 5 Internal Battery vaare SM akariakoyidide tiaras 6 1 Oo Battery Capacity isescitasceccccusaccudncce Senad debts dakicdtase 6 1 62 Batey Operaio Vvs a a a eaa n at 6 2 6 3 Testing the Battery ua dated toda ed AEA ENERG 6 4 6 4 Recharging the Battery ccc ccc cece eect e eee e eens eeeeeees 6 4 65 S NNO ne Battery tmnt ccrrchacdesadeetedehtadenaavenielsmiebtaurteensacrneted 6 5 66 Replacing the Battery ic cccetsetetdeewe Geel washes asuae TRENTON GEVA TTL 6 6 CIO ANING 50 tar edt aed aaae daw e teense uetewdndewineewdadactnss 7 1 7 1 Cleaning the Ventilator 0 0 0 ccc ccc ccc ccc cee cee eee eee eee eee ananasen 7 1 72 Cleaning ne ACCESSONES sansene ke tee kadre 7 2 Routine Maintenance 0 ccc ccc cece cence cence cence sense eenens 8 1 81 Replacing the Arinet
83. elchair Environmental conditions may cause the filter to become dirty more rapidly Caution e Failing to replace a dirty filter or operating the ventilator without a filter may cause serious damage to the ventilator e 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 proceed as follows 1 Hold the filter between your fingers see Figure 8 1 item 1 2 Remove the filter Figure 8 1 item 2 and discard it 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 Puritan Bennett 540 Ventilator User s Manual 8 1 Routine Maintenance M UR Figure 8 1 Replacing the Air Inlet Filter 8 2 Recommended Schedule of Maintenance 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 and so on the intervals for replacing the ventilator s consumable elements are as follows
84. ennett 540 Ventilator User s Manual v This page intentionally blank Figures Figure 1 1 Figure 1 2 Figure 1 3 Figure 1 4 Figure 1 5 Figure 2 1 Figure 2 2 Figure 2 3 Figure 2 4 Figure 2 5 Figure 2 6 Figure 3 1 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 4 16 Figure 4 17 Figure 4 18 Figure 5 1 Figure 5 2 Figure 5 3 Figure 5 4 Figure 6 1 Figure 6 2 Figure 6 3 Figure 8 1 Figure C 1 Figure C 2 Locations of Labels Top Front View ccc ccc ccc eee eee teen tenes eeeees 1 16 Locations of Labels Front Left View ccc cece cece cece een e ee eeeeeneees 1 16 Location of Labels Front Right View cc cece cece cece e eee e eee eeeeees 1 17 Location of Labels and Markings Back Left View 0 ccc cece cece eee eees 1 17 Location of Labels Bottom Front View cc cece ccc cen eee e eee eeees 1 18 FOM PN ane eud salen aaah ea aula theses te 2 3 Back Panel arva ee 2 4 Goa 11 0 EE EEE T Bnparne a ENA ER 2 5 Ventilation Menu Display 0 cc ccc cece cece cece eee a ee eeeeeeees 2 6 AAN NE 2 7 Waveforms Mensa eee Eker 2 8 Alarm DiSpl ys usage hasteeeesenu eee 3 2 AG Power Cable Holder vaare tende ne Aa Ged AI ere A 4 2 Inserting the Power Cable Holder Into the Notch
85. ent 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 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 Verify the functionality of the alarms conditions before connecting the patient to the ventilator If the ventilator fails the alarm tests or if you cannot complete the tests refer to chapter 3 Alarms and Troubleshooting or call your equipment supplier or Puritan Bennett 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 the ventilation will resume without having to press the VENTILATION 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 infec
86. entilator is powered on e 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 and the audible alarms briefly sound e The display s backlight turns on e The PURITAN BENNETT logo is momentarily displayed e The blue VENT STDBY indicator to the right of the VENTILATION ON OFF key illuminates indicating the device is in standby mode e A Welcome Menu screen is displayed for about five 5 seconds which includes the machine counter and the patient counter as shown in Figure 5 2 Puritan Bennett 540 Ventilator User s Manual 5 1 Operating Procedures 5 2 JAN 01 2009 HELLO 12 00 54 am Machine 000004 Patient 00000 00min Software version LU01007c AL01003a PURITAN BENNETT 540 1 Copyright 2009 COVIDIEN Figure 5 2 Welcome Menu Screen Note e 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 e 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 To Skip the Welcome Menu Screen To skip the Welcome Menu screen press the VENTILATION ON OFF key to start ve
87. er damaged nor compressed and contain no obstructions or foreign bodies e You must start the ventilator and allow it to complete one full breath cycle prior to connecting the patient Do not connect the patient before the first full breath cycle is completed When the ventilator is on standby the ventilator is on but ventilation has not started a message that prompts the ventilator operator to press the VENTILATION ON OFF key to start ventilation is displayed in the right hand window of the ventilation and alarm menus Figure 5 3 VOL A C H 04n15 vit S00mL M a BEEF OFF Ramp E F Rate 13 bpm InspTime 1 55s 3 al TO START Insp Sens VENTILATION Preferences c mH20 Figure 5 3 Prompt to Start Ventilation To start ventilation proceed as follows Press and release the VENTILATION ON OFF key Figure 5 4 item 1 e The blue light indicator at the upper right of the VENTILATION ON OFF key see Figure 5 4 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 Puritan Bennett 540 Ventilator User s Manual 5 3 Operating Procedures VENT STD BY O 2 Front Panel Keyboard PURITAN BENNETT 540 Ventilator VENTILATION ON OFF Figure 5 4 Starting Ventilation 5 3 Stopping Ventilation N WARNING Do not allow a patient to remain connected to the ventilator when ventilation is s
88. er the patient damage the ventilator and or void your warranty Only qualified service personnel should repair or service the ventilator In the event of a problem with the ventilator refer to chapter 3 Alarms and Troubleshooting If you cannot determine the cause of the problem contact your equipment supplier or Puritan Bennett Corporate Address Technical Service Phone Numbers Covidien Troubleshooting your portable ventilator 1 800 255 6774 6135 Gunbarrel Avenue Servicing your portable ventilator 1 800 255 6774 Boulder CO 80301 U S A Puritan Bennett 540 Ventilator User s Manual 8 3 Routine Maintenance 8 4 This page intentionally blank Puritan Bennett 540 Ventilator User s Manual A 1 A 2 Specifications Physical Table A 1 Physical Description Excluding Accessories Ventilator Weight 9 9 Ib 4 5 kg Ventilator Dimensions 9 25 in wide x 12 40 in deep x 6 0 in high 235 mm wide x 315 mm deep x 154 mm high Connectors Inspiratory limb connector ISO 22 mm OD conical Expiratory limb connector on expiratory block ISO 22 mm ID conical Oxygen inlet Female Connector with valve e Adult dual limb 1150 ml e Pediatric dual limb 670 ml e Adult single limb 550 ml e Pediatric single limb 300 ml 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 Efficien
89. es lighted cigarettes and all other sources of ignition such as flammable anesthetics and or heaters away from the ventilator and oxygen hoses If the ambient temperature is above 104 F 40 C the battery s thermal cut off circuit may prevent the battery from recharging fully even if the INTERNAL BAT charging indicator indicates the battery is completely recharged 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 8 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 Handle the ventilator with care during and after use particularly when room temperatures are high Some ventilator surfaces may become hot even if safety specifications are not exceeded Electrical Power Supplies 1 4 Never connect your ventilator to an electrical outlet controlled by a wall switch because the power may be inadvertently turned off 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 4 2 Connecting to External AC Power The power supply to which the ventilator is connecte
90. ever 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 Fluid or moisture of any kind must not be allowed to seep inside the ventilator Particular areas of vulnerability include the air inlet filter and the cooling apertures located in the side rear and bottom panels of the ventilator If exhaled tidal volume or exhaled minute 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 High and Low VTE alarm parameters must be properly set to warn in the event of patient suffocation To minimize the risk of damage you must use the ventilator s Dual Bag to transport the ventilator Regularly check the cleanliness of the air inlet filter located on the rear of the ventilator Replace the filter as often as necessary to maintain cleanliness even before the recommended replacement period is over This is critical particularly when the ventilator is installed on a wheelchair because environmental conditions may cause the filter to become dirty more rapidly Puritan Bennett 540 Ventilator User s Manual Mounting the Ventilator on the Utility Cart Caution Before using the ventilator on the internal battery ensure that it is charged and that the charge hold
91. f the following is true a normally closed NC orange e Audio paused function is active e Ventilator power switch is turned off an normally open NO The remote alarm port is an 8 pin female connector Allowable current is 100 mA at 24 VDC maximum remote supply not used remote supply not used pe AE Indicators and Alarms Puritan Bennett 540 Ventilator User s Manual Performance Table A 5 Power Indicators Ventilation ON OFF INTERNAL BAT 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 A 6 Alarm Indicators High Priority Medium Priority Red flashing LED Yellow flashing LED Table A 7 Audio Alarms Audio Paused Alarm Volume 60s 15 65 to 85 dBA 10 at 1 meter A 4 Performance A 4 1 Specifications Table A 8 Performance Parameter Specifications and Tolerances semings range Tolerances A 4 2 Test Results Table A 9 Volume Performance Test Results vem s o s 2 0 o o oo O prms 40 20 13 vo o7 os oa 03 VTI min ml Mime ma 1000 900 700 ao na na ma mme Tf Iumlmlm Puritan Bennett 540 Ventilator User s Manual A 3 Specifications A 5 Table A 9 Volume Performance Test Results ver s o o 0 wo so pre a0 20 13 10 o7 og oa 0
92. f the exhalation valve and accessories water traps filters etc must be as low as possible 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 Donot start ventilation until you ensure that the device is suitably assembled and that there is proper clearance all around the unit Ensure that the air inlet filter is properly installed and is not obstructed 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 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 Filters WARNING Regularly check the cleanliness of the air inlet filter located on the rear of the ventilator Replace the filter as often as necessary to maintain cleanliness even before the recommended replacement period is over This is critical particularly 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
93. families For more details on the knowledge and skill requirements for operating the Puritan Bennett 540 Ventilator Ventilator refer to Appendix A Patient Caregiver Checklist in the Clinician s Manual N WARNING Federal law restricts this device to sale by or on the order of a licensed physician 2 2 Contraindications This ventilator is not for use with anesthetic gases and is not intended for use as an emergency transport ventilator Puritan Bennett 540 Ventilator User s Manual 2 1 Ventilator Overview 2 3 2 4 Operational Use The Puritan Bennett 540 Ventilator uses a micro turbine and the patient circuit with integral exhalation valve to provide ventilatory support to patients Clinicians may use a variety of interfaces to connect patients to the ventilator nasal or full face masks endotracheal or tracheotomy tubes User selectable ventilation modes are e Assisted Controlled Volume VOLUME A C e Assisted Controlled Pressure PRESSURE A C e Synchronous Intermittent Mandatory Ventilation Volume V SIMV e Synchronous Intermittent Mandatory Ventilation Pressure P SIMV e Continuous Positive Airway Pressure CPAP e Pressure Support Ventilation PSV 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
94. from the ventilator whenever the oxygen supply is not in use or the connector is not connected to a leak proof external oxygen supply Otherwise a leak may occur and compromise the performance of the ventilator In the event of an oxygen leak immediately shut down the oxygen supply at its source and keep away from any incandescent source or other possible sources of ignition Thoroughly air the room to bring the oxygen concentration down to normal To prevent any interference with the internal sensors of the Puritan Bennett 540 Ventilator do not install a humidifier upstream of the ventilator Caution The oxygen supply hose ages and degrades even when it not in use and should be replaced periodically The exhalation date of the hose may be indicated on the back of the hose s end piece The oxygen supply must be shut off whenever ventilation is interrupted Allow the ventilator to continue for a few cycles without oxygen whenever ventilation is stopped or started The external oxygen source must also have independent means of flow adjustment from the ventilator Mounting the Ventilator on a Wheelchair N WARNING Do not rely solely on the ventilator s internal battery to sustain the ventilation Always provide an alternative external power source Due to its limited internal battery s reserve capacity the ventilator should only be operated occasionally while powered by its internal battery Ensure that the internal battery n
95. g manually 3 4 Alarm messages AC POWER DISCONNECTION 3 7 3 14 AMBIENT TEMP 3 15 APNEA 3 7 3 15 BATT FAULT1 CALL SERVICE 3 7 3 15 6 4 BATT FAULT2 CALL SERVICE 3 7 3 15 BATT FAULT3 CALL SERVICE 3 7 3 15 BATT FAULT4 REPLACE VENT 3 7 3 15 BATT TEMP FAULT 3 7 BATTERY TEMP 3 16 CAL FAULT 3 7 CALIBRATION FAIL 3 16 CHECK PROXIMAL LINE1 3 8 3 16 CHECK CHANGE EXH VALVE2 3 8 CHK EXH VALV RESTART VENT 3 8 3 16 CHK VOL INSP TIME SETTINGS 3 9 3 17 DEVICE FAULT1 REPLACE VENT 3 9 3 17 DEVICE FAULT2 REPLACE VENT 3 9 3 17 DEVICE FAULT3 REPLACE VENT 3 9 3 17 DEVICE FAULT4 REPLACE VENT 3 9 3 17 DEVICE FAULT5 REPLACE VENT 3 9 3 17 DEVICE FAULT6 REPLACE VENT 3 9 3 17 DEVICE FAULT7 REPLACE VENT 3 9 3 17 EMPTY BATTERY 3 10 3 17 6 4 EXHSENS FAULT OR CRKT LEAK 3 10 3 17 HIGH DEVICE TEMP COOL VENT 3 10 HIGH EXH VOLUME 3 10 3 18 HIGH INSP VOLUME 3 10 3 18 HIGH MINUTE VOLUME 3 10 3 18 HIGH PRESSURE 3 11 3 18 HIGH RATE 3 11 3 19 INVERSED IE RATIO 3 11 3 19 KEYPAD FAULT CALL SERVICE 3 11 3 19 LOW BATTERY 1 4 3 11 3 19 6 4 LOW EXH VOLUME 3 11 3 19 LOW INSP VOLUME 3 12 3 20 LOW MINUTE VOLUME 3 12 3 20 LOW PRESSURE DISCONNECT 3 12 3 20 OCCLUSION CHECK CIRCUIT 3 12 3 20 ON INTERNAL BATTERY 3 12 3 20 4 6 POWER FAULT REPLACE VENT 3 13 3 20 POWER SUPPLY LOSS no message 3 13 3 21 REMOTE ALARM FAULT 3 13 3 21 SOFTWARE VERSION ERROR 3 13 3 21 SPKR FAULT REPLACE VENT 3 13 3 21 Alarms display of 3 2 Level of p
96. gh Min Vol High Respiratory Rate High Rtot Monitored Patient Data Range 2 L to 99 L Resolution 0 5 L Default value OFF Depends on Vt R Rate Low Min vol Range 10 bpm to 70 bpm Resolution 1 bpm Default value OFF Depends on R Rate Peak inspiratory pressure PIP Positive end expiratory pressure PEEP Inspiratory tidal volume VTI Expiratory tidal volume VTE Inspiratory minute volume Min VI Expiratory minute volume Min VE Total respiratory rate R tot Mean airway pressure MAP LE ratio I E Inspiratory time I time Expiratory time E time Puritan Bennett 540 Ventilator User s Manual Range 0 cmH30 to 99 cmH 0 Resolution 1 cmH5O Accuracy 0 2 cmH5 0 8 Range 0 cmH gt 0 to 99 cmH 0 Resolution 1 cmH0 Accuracy 0 2 cmH gt 0 8 Range 0 mL to 9 995 mL Resolution 5 mL Accuracy 10ml 10 Range 50 mL to 9 995 mL Resolution 5 mL Accuracy 10ml 10 for volumes gt 50ml A symbol is displayed for volumes below 50ml Range OL to 99 9 L Resolution 0 1 L Accuracy 20 Range 0 L to 99 9 L Resolution 0 1 L Accuracy 20 Range 0 bpm to 99 bpm Resolution 1 bpm Accuracy 1 bpm Range 0 cmH30 to 99 cmH50 Resolution 1 Accuracy 0 2 cmH20 8 Range 9 9 1 to 1 9 9 Resolution 0 1 Accuracy 50ms or 10 whichever is greater Range 0s to 59 9 s Resolution 0 1 s Accuracy 50 ms or 5 whichever
97. he Puritan Bennett 540 Portable Ventilator General Precautions For Installation Caution Environment 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 Electrical Power Supplies e Before using the ventilator s internal battery ensure that the battery is fully charged and that the charge holds e Do not store the internal battery either installed within or removed from the ventilator for more than two 2 years e To connect the ventilator to an external power source first ensure the ventilator s I O switch is off 0 Then connect the desired power cable to the ventilator Finally connect the power cable to the external power source e 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 e Do not leave power cables lying on the ground where they may pose a hazard e Ensure that the AC power cable is in perfect condition and not compressed e To connect the ventilator to a Nurse Call device contact Puritan Bennett 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 possibl
98. he 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 Symbols _ Symbols N TO AN FROM PATIENT AG FS single patient ANY protection against water dripping or falling vertically as well as an environment featuring water vapor condensation and or light rain This rating appears on the ventilator s back panel see Table 1 2 item 6 CSA Canadian Standards Association This symbol appears on the ventilator s back panel see Table 1 2 item 6 This symbol appears on the ventilator s front panel UP UNFREEZE key see Figure 2 3 on page 2 5 item 6 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 5 item 5 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 5 item 4 This key is used to confirm command actions This symbol appears on the ventilator s front panel ALARM CONTROL key see Figure 2 3 on page 2 5 item 3 This key is used to cancel the audible portion of
99. he second group consists of persons that transport the goods because they need the product to execute their job s The later group is able to carry transport certain hazardous materials such as the Puritan Bennett 540 Ventilator and the associated Lithium ion battery ies under the established Materials of Trade MOT provisions detailed in 49 CFR 173 6 For any other group or purpose transport must be compliant with the applicable Hazardous Materials Dangerous Goods regulations specific to the origin destination and mode of transport Air transport of the Puritan Bennett 540 Ventilator in only allowed as carry on baggage which may include up to two 2 individually packaged spare Lithium ion batteries it is recommended that users verify specific requirements limitations with the airline carriers as to which measures to take before the voyage e Even though the Puritan Bennett 540 Ventilator meets current safety standards the internal Lithium ion battery of this device contains more than 8g equivalent lithium and exceeds a power rating of 100 Wh watt hour and therefore considered to be a Hazardous Material Dangerous Good Class 9 Miscellaneous when transported in commerce As such the Puritan Bennett 540 Ventilator and or the associated Lithium ion battery are subject to strict transport conditions established by the US Department of Transportation 49 CFR 173 185 as well as other international transportation regulations This cl
100. he wet circuit components with dry ones Refer to the humidification device s instruction for information on operating cleaning and sterilizing the humidifier Exhalation Block N WARNING The exhalation block is for single use by a single patient 2 It may be periodically cleaned but it cannot be disinfected or sterilized To maintain good measurement quality when the ventilator is in continuous use change it every three months Each time an exhalation block is installed the expiratory flow sensor must be recalibrated before using the ventilator Caution Ensure that the exhalation block has been completely dried after it is cleaned Puritan Bennett 540 Ventilator User s Manual Oxygen The exhalation block requires calibration and should only be removed or cleaned by qualified personnel Figure 4 13 Removing the Exhalation Block 4 8 Oxygen N WARNING The ventilator must not be used with flammable anesthetic substances 4 8 1 Administering Oxygen N WARNING Oxygen therapy for patients with respiratory failure is a common and effective medical prescription However oxygen therapy should always be used with the utmost care too high an oxygen flow is likely to lead to serious complications for the patient 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 del
101. hen no alarm has been activated NO DATA is displayed on the screen see graphic below Puritan Bennett 540 Ventilator User s Manual 3 3 Alarms and Troubleshooting 3 4 ALARM LOG O REACTIVATE PAUSED ALARM m Back For more information on the Reactivate Paused Alarm line refer to section 3 6 Re activating Alarms on page 3 6 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 540 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 EN is displayed at the top right of the screen while the audio pause function is active VTL 976mm MAP OcmH20 PEEP FemH20 IE 4 2 LOW PRESSURE DISCONNECT J 09r21 07 10 34 am o Al
102. here the 11 humidifier item 2 water traps See alco ere item 3 and their connecting on page 4 9 10 tubes are not included with the patient circuit or ventilator Contact your supplier for more 1 information D G SR D HH 9 2 7 2 E Figure 4 8 Double Limb Patient Circuit 9 Place the exhalation valve item 9 on the exhaust port 10 Place a bacteria filter item 10 between the exhalation valve item 9 and the inlet port of the ventilator exhalation block item 11 11 Connect one end of the small exhalation valve tubing item 8 to the exhalation valve port of the exhalation valve item 11 and the other end onto the ventilator exhalation valve port Figure 4 9 shows details of the connections of the proximal pressure tube Figure 4 8 item 6 and the exhalation valve tube Figure 4 8 item 8 Exhalation Inhalation Port Valve Tube Proximal Pressure Tube Figure 4 9 Close up of Exhalation Valve Tube and Proximal Pressure Tube 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 best to modify the LOW PRESSURE DISCONNECT triggering threshold by doing one of the following set the high VTI alarm limit for pressure modes or
103. ids avoid ingress into ventilator Warning 1 3 7 1 Lithium internal battery Dangerous Goods classification 6 1 Logs menu alarms 3 3 LOW BATTERY alarm message 1 4 3 11 3 19 6 4 LOW EXH VOLUME alarm message 3 11 3 19 LOW INSP VOLUME alarm message 3 12 3 20 LOW MINUTE VOLUME alarm message 3 12 3 20 LOW PRESSURE DISCONNECT alarm message 3 12 3 20 M Machine counter 5 1 Maintenance schedule recommended 8 2 Manufacturer s declaration specifications A 13 Markings 1 10 1 13 Menu alarms 2 7 ventilation 2 6 waveforms 2 8 Modes of Ventilation D I Monitored parameter specifications A 4 N NO DATA message Alarm Logs screen 3 3 Non Invasive Ventilation NIV 4 10 Nose or face mask use of 4 10 Notes definition of 1 1 Nurse Call cable 4 18 Nurse call system connecting the cable to the ventilator 4 18 O OCCLUSION CHECK CIRCUIT alarm message 3 12 3 20 ON INTERNAL BATTERY alarm message 3 12 3 20 4 6 Operational verification checklist B 1 Operator Users Index 3 Index targeted for use of ventilator 2 1 O ring oxygen coupler Caution 4 14 Oxygen connecting the supply 4 14 connecting the supply to the ventilator 4 15 connector stud 4 14 disconnecting the supply from the ventilator 4 15 enrichment 2 2 flow adjustment 4 16 rear panel connector figure 4 14 shut off supply when ventilation stops Caution 4 16 special coupler 4 14 supply connection 4 14 supply hose expiration date Caution 4 1 using
104. igarette lighter Remote alarm cable 5 meters USB cable mini B 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 8 1 Consumables and Replacement Intervals on page 8 2 Internal battery External battery Puritan Bennett 540 Ventilator User s Manual Parts and Accessories Table E 1 List of Consumables and Accessories Description DAR Inspiratory Bacteria Filters Barrierbac Barrierbac S Barrierbac S Angled Hygrobac Hygrobac S Hygrobac S Angled Hygroboy Hygroster Hygroster Mini Sterivent Sterivent S Sterivent Mini Hygrolife II Table E 2 provides a list of consumable parts available for the ventilator N WARNING e To ensure proper performance of the ventilator use a patient circuit recommended by Puritan Bennett in this manual refer to chapter 4 Installation and Assembly The total specified length of the patient circuit tubing as measured from the ventilator outlet to the ventilator inlet is 3 6 feet 1 10 meters to 6 6 feet 2 00 meters 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 pediat
105. ight of the Ventilation Alarms and Waveforms screens See the sample screen below vr 976m MAP OcmH20 PEEP f cmH20 IE 14 2 HiH TEMPERATURE COOL VENT J 09r21 07 10 34 arn E Alarm Log 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 as shown above The High Pressure alarm must be manually reset Refer to section 3 7 Overview of Alarms on page 3 F To manually reset the High Pressure Alarm proceed as follows Press the ALARM CONTROL X key twice e The visual alarms will be reset Puritan Bennett 540 Ventilator User s Manual 3 5 Alarms and Troubleshooting 3 6 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 CD key to access the Alarm Setting menu if this is not the menu currently displayed 2 Press the DOWN 6 v key to position the cursor on the Alarm Logs line if this is not already the case The following graphic shows an example of the resulting display Witt 1120m MAP OcmH20 PEEP FemH20 LE 4 2 INVERSED E RATIO 0924 07 08 42 am E Alarm Log 3 Press the ENTER WY key to confirm access to the Alarm Logs menu 4 Press the UP 4 key to position the cursor on the Reactivate
106. iratory Pressure High PIP Range 0 5 L to 50 L Resolution 0 5 L Default value OFF Depends on High Min vol Range 2 L to 99 L Resolution 0 5 L Default value OFF Depends on Low Min vol Range 10 bpm to 70 bpm Resolution 1 bpm Default value OFF Depends on R Rate Range PIP 20 not adjustable Resolution N A Range PIP 20 not adjustable Resolution N A Minimum Inspiratory time Range RISE TIME 300ms not adjustable Low I time Maximum Inspiratory time Range Min 3s 30 R Rate not adjustable High time Volume A C Mode Low PIP High PIP Low Exhaled Tidal Volume Low VTE High Exhaled Tidal Volume High VTE Low Minute Volume Low Min Vol Range 2 cmH30 to 52 cmH 0 Resolution 1 cmH30 Default value 2 cmH 0O Depends on PEEP High PIP Range 12 cmH 0 to 60 cmH 0 Resolution 1 cmH0 Default value 40 cmH 0 Depends on PEEP Low PIP Range 30 mL to 1990mL Resolution 10 mL Default value OFF Depends on Vt High VTE Range 80 mL to 3000 mL Resolution 10 mL Default value OFF Depends on Vt Low VTE Range 0 5 L to 50 L Resolution 0 5 L Default value OFF Depends on Vt R Rate High Min vol Puritan Bennett 540 Ventilator User s Manual Range Resolution and Accuracy Table A 11 Ventilator Range Resolution and Accuracy Continued Setting or Monitored Parameter Range Resolution and Accuracy High Minute Volume Hi
107. irst 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 4 symbol is displayed at the top on the general information line e Battery reserve capacity is displayed on the right of the 4 symbol e The INTERNAL BAT indicator at the top left of the ventilator s front panel is continuously lit Figure 6 1 6 2 Puritan Bennett 540 Ventilator User s Manual Battery Operation INTERNAL BAT FOLLOW INSTRUCTIONS FOR USE Figure 6 1 Internal Battery Indicator e A loss of external supply alarm is activated e A beep sounds every five 5 minutes to remind the user that the ventilator is being powered by its internal battery If ventilation is stopped the internal battery reserve capacity is displayed as a percentage of battery charge as shown in the following graphic PRES A C 1 45 P Control 75cmH20 m PEEP OFF pr 40 rmHa0 Rise Time 2 1105m0 R Rate 13 bpm AFAd mi InspTime 1 5s Insp Sens 3 0 0L 2 I bpm o E 1 2 20 10 E cmH20 If the ventilator is running the internal battery reserve is momentarily displayed as a percentage Then after the ventilator calculates the battery time remaining which takes about two minutes
108. is the recommended sepa ration distance in meters m 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 GY Puritan Bennett 540 Ventilator User s Manual A 15 Specifications Table A 21 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 ra
109. ivered air It is recommended that the oxygen ports on the ventilator be capped when 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 setting 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 Note To monitor patient Oxygen levels use an external sensor alarm Puritan Bennett 540 Ventilator User s Manual 4 13 Installation and Assembly N WARNING 4 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 25 psi 49 99 kPa or a flow of 15 Ipm Refer to Table A 17 on page A 12 ThePuritan Bennett 540 does not include an oxygen analyzer Always measure the delivered oxygen with a calibrated oxygen analyzer that features a high and low concentration alarm in order to ensure that the prescribed oxygen concentration is delivered to the patient 8 2 Connecting the Oxygen Supply N WARNING Ensure that the only gas supp
110. k 8 2 patient circuit 8 2 Replacing air inlet filter 8 1 Replacing the internal battery 6 6 Resetting alarms 3 5 Risk of fire warning 4 1 S Safety onboard alarm system 2 2 Service assistance information 8 3 SOFTWARE VERSION ERROR alarm message 3 13 3 21 Specifications electrical A 1 environmental A 12 indicators and alarms A 2 manufacturer s declaration A 13 monitored parameters A 4 performance A 3 physical A 1 pneumatic A 12 range resolution and accuracy A 5 standards compliance and IEC classification A 17 ventilator A 1 SPKR FAULT REPLACE VENT alarm message 3 13 3 21 Standards compliance and IEC clasiification specifica tions A 17 Starting ventilation 5 2 Stopping ventilation 5 4 Storing the internal battery 6 5 Stud oxygen connector 4 14 Puritan Bennett 540 Ventilator User s Manual Symbols 1 10 T Technical faults 3 1 Technical Services Puritan Bennett 2 8 Testing internal battery 6 4 Tidal volume and pediatric use Warning 1 6 Transport emergency ventilator not intended for 2 1 Troubleshooting alarms 3 14 other problems 3 21 Turning off the ventilator 5 5 Turning on the ventilator 5 1 U Unpacking and preparing the ventilator C 1 V VENT STDBY indicator 5 1 Ventilation menu 2 6 starting 5 2 stopping 5 4 Ventilation modes 2 2 D 1 VENTILATION ON OFF key 5 1 Ventilator cleaning 7 1 connecting the nurse call cable 4 18 connections proper warning 1 3 4 1 failure of 2 8 filters
111. lectric shock Class II e Protection index of enclosure IP31 e Medical device directive classification II B e Degree of protection against risk of electric shock BF e Power External AC mains or DC cigarette lighter or internal DC battery e Operation mode Continuous operation Puritan Bennett 540 Ventilator User s Manual Front Panel For additional information refer to section A Specifications 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 the ventilation on and off configuring ventilation modes silencing and canceling alarms and setting device and alarm parameters Patient Connection Port Provides an outlet for the air to be delivered to the patient via the patient circuit Patient Pressure Monitoring Port Nipple for monitoring proximal patient pressure 8 Exhalation Valve Port Nipple for providing piloting pressure to the exhalation valve Controls the open closed position
112. lied 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 no 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 4 14 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 and a locking tab item 4 Figure 4 14 Rear Panel Oxygen Connector Caution Before connecting the oxygen supply ensure that the stud on the oxygen connector Figure 4 14 item 3 is protruding outwards Inspect the oxygen coupler Figure 4 15 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 Puritan Bennett 540 Ventilator User s Manual Oxygen To connect the oxygen supply system to the ventilator proceed as follows and refer to Figure 4 15 1 Inspect the oxygen supply s connector Figure 4 15 item 1 to ensure that conn
113. lity IEC 60601 1 6 2006 e General Requirements tests and guidance for alarm systems in medical electrical equipment and medical electrical systems IEC 60601 1 8 2004 Particular Standards e Lung Ventilators for Medical Use Particular Requirements for Basic Safety and Essential Performance Part 2 Home Care Ventilators for Ventilator Dependent Patient IS010651 2 2004 e Standard Specification for Ventilators Intended for Use in Critical Care ASTM F 1100 1997 Puritan Bennett 540 Ventilator User s Manual A 17 Specifications This page intentionally blank Puritan Bennett 540 Ventilator User s Manual B Operational Verification Checklist The operational verification and safety checks listed in Table B 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 3 8 Troubleshooting on page 3 14 or call the equipment supplier or Puritan Bennett N WARNING e Provide the patient with an alternate means of ventilation before conducting these tests e To reduce the risk of infection wash your hands thoroughly before and after handling the ventilator or its accessories Table B 1 Operational Verification Checklist
114. low shape flow distribution shape inspiratory phase parameter These symbols appear on the ventilation mode menu screens selectable for Vol A C mode only For more information refer to chapter 3 Operating Parameters In volume ventilation modes you can select between Square SQ or Descending D flow patterns Selected line filled square When making menu choices this graphic indicates the line on which the cursor is currently positioned 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 5 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 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 6 Puritan Bennett 540 Ventilator User s Manual Labels
115. m 10 To connect a double limb circuit do the following and refer to Figure 4 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 2 Install the bacteria filter item 1 on the TO PATIENT outlet port 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 humidifier s inlet port 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 a water trap item 3 between the patient wye and the inlet port of exhalation filter item 5 7 Connect one end of the small proximal pressure tubing item 6 as close as possible to the patient at the level of the double limb patient wye circuit connection item 5 and the other end on the ventilator patient pressure port 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 8 Ensure that the water trap item 3 on the expiratory limb of the patient circuit item 7 is securely installed between the patient wye item 5 and the exhalation valve item 9 4 8 Puritan Bennett 540 Ventilator User s Manual Patient Circuit NOTE Although shown
116. medical grade only Warning 1 8 4 14 P Parts and accessories E Patient outlet port connections figure 4 9 Patient Circuit 4 6 choosing 4 7 installing 4 7 Patient circuit attaching to ventilator 4 6 double limb connecting 4 8 length and internal volume 4 10 replacement interval 8 2 single limb connecting 4 7 Patient counter 5 1 Patient wye blocking for expiratory flow sensor calibration fig ure 8 1 Patients targeted for use of ventilator 2 1 Performance specifications A 3 Personnel Qualification of Preface 1 Physical specifications A 1 Placing the ventilator installing 4 1 Pneumatic specifications A 12 POWER FAULT REPLACE VENT alarm message 3 13 3 20 Power On Self Test POST 5 1 POWER SUPPLY LOSS no message alarm 3 13 3 21 Precautions for use cautions electromagnetic interference 1 10 general 1 9 installation environment 1 9 maintenance 1 9 oxygen 1 10 Precautions for use warnings general 1 2 Index 4 installation electrical power supplies 1 4 environment 1 3 maintenance 1 7 oxygen 1 8 settings 1 7 Problems 3 2 1 Puritan Bennett Technical Services 2 8 R Range resolution and accuracy specifications A 5 Reactivating alarms 3 6 Recharging the internal battery 6 4 REMOTE ALARM FAULT alarm message 3 13 3 21 Repairing the ventilator qualified personnel only Warning 8 1 8 2 Replacement intervals air inlet filter 8 2 air outlet antibacterial filter 8 2 consumables 8 2 exhalation bloc
117. menu screen press this key to display the Alarm menu screen VENTILATION ON OFF button e Press briefly and release to start ventilation e Press for three 3 seconds to stop ventilation Ventilation status indicator e Blue indicator illuminated device is powered on and ventilation is off on standby e Blue indicator off ventilation is on Electrical power source indicators e AC POWER indicator lit AC power source connected e DC POWER indicator lit DC power source connected e INTERNAL BAT indicator lit continuously Ventilator powered by internal battery no external power source connected e INTERNAL BAT indicator flashing battery charging Figure 2 3 Control Panel Puritan Bennett 540 Ventilator User s Manual Ventilator Overview 2 8 Ventilation Menu VOL A C vt 500mL Ma PEEP OFF is Ramp ct 0 Ventilation menu with ventilation on R Rate 13bpm s standby InspTime EE ee ae 5 Insp Sens 13 VENTILATION 6 Preferences awa VOL A C Vt ELL rn PEEP OFF ies ae Ramp E Ventilation menu during ventilation R Rate 43bpm InspTime 1 5s z 5 Insp Sens 3 B 6 O Preferences cores 1 General information line Ventilation settings 3 Preference menu access line Displays the current ventilation Displays the specific ventilation Highlight this line and press the mode along with the parameter values for the currently ENTER Q key to display the following selected ventilation mode Prefe
118. n cycle Minimum Exhalation Time Minimum exhalation time before allowing the patient inspiratory trigger Puritan Bennett 540 Ventilator User s Manual F 3 Glossary Minimum Inspiratory Time Minimum inspiratory time before allowing the patient to exhale Minute Volume Minute Volume represents the total amount of gas volume moved into the lungs over a 60 second period It is calculated by multiplying the average breath to breath inspired gas volume Tidal Volume in liters or milliliters by the respiratory rate in breaths per minute Minute volume is usually expressed in Liters per minute and is a better reflection of the patient s total ventilation status than either respiratory rate or tidal volume alone Pause Waveforms freezing function Patient Breath Breathing cycle initiated by the patient 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 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 Augmentation of the patient s ventilation synchronously with inspiratory effort until a preset pressure is met Pressure is maintained throughout patient inspiratory flow and is cycled to expiration by time
119. n page 5 3 5 4 Turning Off the Ventilator N WARNING e When ventilation is in progress if the ventilator is stopped using the I O switch without previously stopping the ventilation a continuous audible alarm is activated e When the ventilator is switched back on it will immediately begin ventilating without the user first having to press the VENTILATION ON OFF key Set the I O switch to the O position to power off the ventilator e The blue LED to the right of the VENTILATION ON OFF 0 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 N WARNING Handle the ventilator with care after use particularly when room temperatures are high Some ventilator surfaces may be very hot even if safety specifications are not exceeded Puritan Bennett 540 Ventilator User s Manual 5 5 Operating Procedures This page intentionally blank 5 6 Puritan Bennett 540 Ventilator User s Manual 6 Internal Battery 6 1 N WARNING Because the internal battery of the Puritan Bennett 540 Ventilator contains more than 8 grams equivalent lithium it is categorized as Dangerous Goods DG Class 9 even though the ventilator meets current safety standards The ventilator because of this categorization is subject to strict transport condi
120. n the case of pediatric use ensure that the adjusted tidal volume is compatible with the needs of the child Ensure that the tidal volume setting in VC is compatible with the needs of 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 If APNEA TIME is set to a value higher than 60 Control R then the APNEA alarm will not activate Setting Alarm limits to extreme values can cause the ventilator alarms to malfunction 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 540 Ventilator User s Manual Warnings Maintenance Precautions N WARNING J 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 Puritan Bennett e 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 e Except for replacing the internal battery and cleaning the device do no
121. nd 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 Frequency Sound Signaling Flashing Yellow LED Illumination With Message With Display Lighting Note There are currently no Low Priority LP Alarms Puritan Bennett 540 Ventilator User s Manual 3 1 Alarms and Troubleshooting 3 2 3 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 An alarm tone sounds e A message is displayed and flashes in reverse video at the bottom of the Ventilation Menu or Alarm Menu AUDIO PAUSED AC POWER DE TOER Vannet w ALARM PAUSED ALARM RESET ALARM INDICATORS ALARM MENU VOL A C vt 500m Gan PEEP eee F0cmH20 Ramp Em MT 2 1266 ml R Rate 13 bpm TE 157 Min O 0L F tot 24 bom IE 4 2 10 HIGH PRESSURE emH20 O Alarm Log NS ALARM MESSAGES vr 1266 me MAP BcmHi0 PEEP FemH20 LE 4 2 InspTime 1 55 Insp Sens AP HIGH PRESSURE Preferences Figure 3 1 Alarm Displays Note
122. nd power supplies should be disconnected and use of the device stopped immediately e The exhalation block is intended for single use by a single patient It may periodically be cleaned but it cannot be disinfected or sterilized To maintain good measurement quality when used continuously trained personnel should clean the exhalation block periodically The exhalation block should be changed every 3 months and cannot be reused with any other patient e Ensure that the exhalation block is completely dried after cleaning and prior to use e 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 expiratory flow sensor be recalibrated before the exhalation block is used refer to section 10 1 Calibrating the Expiratory Flow Sensor in the Clinician s Manual e The patient circuit is intended for single use by a single patient and should be changed according to the manufacturer s recommendations Refer to the instructions for use supplied by the manufacturer of the patient circuit included with the ventilator and chapter 4 Installation and Assembly e 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 r
123. ns 3 1 31 Alarm LevelonPnonity 0025065 tereti Go ST Seas Canes 3 1 3 AD DI Vaaa en EO ON destotnes 3 2 33 Alarm Logs MMU sae her boots cas etd dele GSE 3 3 3 4 Silencing the Audible Portion of Alarms 0 cc cece cece cette eee eens 3 4 3 5 Resetting Pausing Alarms ccc ccc ccc ccc cee cee eect eee ee eeeeeeees 3 5 36 Re activating Alani ci3 2224000 sets ecatasamoisdeedwsGu dee etaakei fant shawl sheeed 3 6 2 OE NE OE EE ETE OE EE ined Bi tacbelawitaeiws 3 7 38 Toublesnooimg as vavsrvssassneeTe enes 3 14 MN 3 14 382 Other Problems myosesssaseterea Bee tn debe eee a 3 21 4 Installation and Assembly 0 c ccc cence cence nee ee een eee 4 1 4 1 Installing the Ventilator 0 cece vnr ee eee T E 4 1 4 2 Connecting to External AC POWEl cece cece cece eee e ee eeeeeeeeee 4 2 4 3 Connecting to an External DC Power Source cece ccc cee eee eee eeee 4 5 Puritan Bennett 540 Ventilator User s Manual iii Contents AA Patient CWGCUIG se surs t eder 4 6 4 4 1 Choosing the Patient Circuit Type ccc ccc cece eee eee eenes 4 7 4 4 2 Installing the Patient Circuit ccc cc ee ee ee eee e eee e ee eeenes 4 7 45 n E E E E See 4 10 26 nl rase 4 11 47 vEXWalatlon BIOCK cenena rer 4 12 AD OV JENS 4 13 4 8 1 Administering Oxygen ccc ccc cc ccc eee cece nent eeeeeeeeees 4 13 4 8 2 Connecting the Oxygen Supply ccc cece cece e ee e
124. nspired and V SIMV modes Alarm activation occurs HP Yes No IF PERSISTS e After six consecutive REPLACE VENT breaths once the ventilator has reached its performance limits Faulty internal pressure sensor DEVICE FAULT1 a a REPLACE VENT Alarm activation occurs HP Yes No e After 15 seconds Faulty proximal pressure sensor DEVICE FAULT2 es REPLACE VENT Alarm activation occurs MP Yes Yes e After 15 seconds DEVICE FAULT3 Failure in the 24 V REPLACE VENT power supply ui IER ne Ventilator cooling fan operating DEVICE FAULT4 speed not suited to the internal REPLACE VENT ambient temperature of the MP Yes Yes device Detection of a fault in the electrical power supply system DEVICE FAULTS Consequence the internal MP Yes Yes REPLACE VENT battery capacity is not displayed beside the battery symbol Turbine speed too high with high temperature DEVICE FAULT6 Consequence ventilation stops HP No No REPLACE VENT immediately and 02 supply stops DEVICE FAULT7 Detection of a fault in sensor HP Yes No REPLACE VENT voltage measurement Inspiratory flow is constant 1 lpm with normal turbine HP Yes No DEVICE FAULTS temperature and speed REPLACE VENT conditions Contact your service representative for assistance Puritan Bennett 540 Ventilator User s Manual 3 9 Alarms and Troubleshooting Table 3 1 Overview of Alarms Continued Alarm Message DEVICE FAULT9 REPLACE VENT DEVICE FAULT10 REPLACE VENT DEVICE FAULT11 REPLAC
125. nterrupted 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 Do not allow a patient to remain connected to the ventilator when ventilation is stopped because a substantial quantity of expiratory 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 The ventilator must not be used with flammable anesthetic substances 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 circuit including all hoses is not damaged or obstructed You must start the ventilator and allow it to complete one full breath cycle prior to connecting the patient Do not connect the patient before this cycle completes Due to its limited internal battery s reserve capacity the ventilator should only be operated occasionally while powered by its internal battery Ensure that the internal battery never becomes fully discharged A ventilator dependent pati
126. ntilation immediately The Ventilation menu is then displayed along with a prompt to press the VENTILATION ON OFF O key to start ventilation as shown in the following graphic PRES A C F Control 1 cmH20 f ap FEEF OF sa RiseTime 2 a ch R Rate 43 bom is InspTime 1 55 TO START Insp Sens 1P VENTILATION 10 IR otorS arog o 1 o Preferences enH20 By default the starting ventilation mode that follows the Welcome menu is the last one used the settings are 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 re saved otherwise the machine will operate on default parameter values Starting Ventilation Before starting ventilation refer to Appendix B Operational Verification Checklist and set the parameter values in the Preferences menu Puritan Bennett 540 Ventilator User s Manual Starting Ventilation N WARNING e Verify the functionality of the main alarms 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 is properly connected to the ventilator and that the circuit hoses are neith
127. oltage on the external source Ventilator s current limiting fuse blown Be prach E venator andea your customer service representative POWER FAULT Internal problem in the electrical power Replace the ventilator and call your REPLACE VENT supply customer service representative 3 20 Puritan Bennett 540 Ventilator User s Manual Troubleshooting Table 3 2 Alarms and Corrective Actions Continued Alarm Message or Possible Reason s For The Alarm Event Corrective Action s Symptom 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 5 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 Connect the Nurse Call cord to the Nurse Call is disconnected ventilator REMOTE ALARM FAULT Call for the maintenance technician and Relay control voltage problem carefully monitor the patient to detect possible alarm triggering gt me ON Incorrect software version detected Call your customer service representative Defective internal buzzers ep tne rd ane ca as customer servi
128. olume exhaled by the patient at each expiratory phase Puritan Bennett 540 Ventilator User s Manual Flow Volume of gas delivered by the ventilator compared to time expressed in liters per minute lpm Freeze Interruption of the waveform plot tracing on the ventilator s display LE ratio Inspiratory time versus exhalation time ratio Inspiratory minute volume Min VI Volume delivered to the patient at each inspiratory phase and multiplied times the respiratory rate Inspiratory Phase Phase of the breath cycle during which the patient inspires Inspiratory Sensitivity Level of inspiratory effort the patient has to provide during the initiation of a machine breath The sensitivity levels from 1 to 5 correspond to differences in flow compared to the bias flow The level 1 is the most sensitive for a pediatric use and requires the least effort to trigger breath The 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 I Time Inspiratory time measure L Liters a unit of volume LED Light Emitting Diode used as indicator lights on the ventilator s front panel lpm Liters 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 ventilatio
129. onnection of the patient circuit to the patient provides for a secure comfortable fit e 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 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 If the ventilator has been transported or stored at a temperature that differs more than 36 F 20 C from the temperature in which it will be operating the ventilator should be allowed to stabilize in its operating environment for at least two 2 hours prior to use Puritan Bennett 540 Ventilator User s Manual 1 3 Safety Information N WARNING Environment Cont d If the room temperature where the device is operated is greater than 95 F 35 C the flow supplied at the device outlet may exceed 106 F 41 C 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 Puritan Bennett The default setting for altitude compensation is YES Altitude compensation should always be set to YES for accurate volume delivery calculations at all elevations To avoid a fire hazard keep match
130. or Puritan Bennett LLC s right to revise or otherwise change or modify the equipment including its software described herein without notice In the absence of an express written agreement to the contrary Nellcor Puritan Bennett LLC has no obligation to furnish any such revisions changes or modifications to the owner or user of the equipment including its software described herein Contents PCT ACO EE EE OE NN NE ET Preface 1 1 S retylnformatlon Lvva4vaovressasegasendassemmedabroeasnnalng 1 1 DENISE See et 1 1 12 WaN S eeceneicr earainn on an N 1 2 15 US NN ANN 1 9 14 Symbol and M rkngssusssarsrarrd sa eda 1 10 1 5 Labels Identification and Instruction Information eee eee eee 1 13 2 Ventilator Overview 0 ccc ccc nce nee n ence nen e beeen eens 2 1 ZA IMGICAONSTONUSC ae eee 2 1 22 COnMtrdinGICatlonsS j 0cse55t Sedat icokestatadeccuiidawiin Tre 2 1 23 Operational ERE EE EN aeaa 2 2 24 DEVICE ClaSsITICAtlON sassavrrnadre druer levetid iaria ke end s 2 2 25 JFFOMNUP ANG Se 2 3 ZG BIK Panele orren a meditate hannte E a a Wack vais Maceo diate aie combs Obie keen 2 4 27 COMO Panel ng i005 0826 64385 a datas hen he OA Sik eh kas 2 5 28 Venton Mena s f045 ase re LE 2 6 20 Am Menig see 2 7 210 Wavefomis Menti sanere 2 8 2 11 If Ventilator Failure Occurs 2 0 0 ccc eee cece eee nee e eee eeeeenes 2 8 3 Alarms and Troubleshooting 0 ccc cece cence nee e nen e ee
131. or pressure inspiratory time and rate If the patient triggers a spontaneous 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 VOL A C if the breaths are based on a volume setting e PRES A C if the breaths are based on a pressure setting D 1 2 SIMV Modes When set to a SIMV Synchronized Intermittent Mandatory Ventilation Mode machine initiated breaths are delivered at a clinician set volume or pressure inspiratory time and rate These mandatory breaths are synchronized with patient effort If the patient triggers a soontaneous 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 If your clinician has prescribed CPAP you should talk to him or her for a further explanation of how CPAP operates Puritan Bennett 540 Ventilator User s Manual D 1 Modes and Breath Types D 1 4 PSV CPAP Mode Lik
132. paration distance d in meters 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 e At 80 MHz and 800 MHz the separation distance for the higher frequency range applies e 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 e 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 e These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Table A 23 Compliant Cables and Accessories Cable or Accessory Maximum length AC power cable North America part no 2971999 5 9 ft 1 8 m Nurse call cable part no 3829800 16 4 ft 5 m 12V DC cables 3824600 TBD A 16 Puritan Bennett 540 Ventilator User s Manual Standards Compliance and IEC Classification N WARNING The use of accessories and cables other than those specified with the exception of par
133. power supply input lines IEC 61000 4 11 Power frequency 50 60 Hz magnetic field IEC 61000 4 8 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 Ur for 0 5 cycle 40 Ur 60 dip in Uy for 5 cycles 70 Ur 30 dip in Ur 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 Ur for 0 5 cycle 40 Ur 60 dip in Uy for 5 cycles 70 Ur 30 dip in Ur for 25 cycles lt 5 Ur gt 95 dip in Ur for 5 s Note U is the AC mains voltage prior to application of the test level 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 f
134. presentative vibrations Replace the ventilator and call your Valve membranes damaged 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 Replace the ventilator and call your inside the device customer service representative No external power source and the internal battery is completely discharged Connect the ventilator to the AC power source Puritan Bennett 540 Ventilator User s Manual 4 Installation and Assembly 4 1 N WARNING The device must not be connected to anti static tubes conduits or electrical conductors 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 Installing the Ventilator To install your Puritan Bennett 540 Ventilator correctly we recommend that you proceed in the following manner Choose an area where air can circulate freely avoid proximity to loose fabrics such as curtains Avoid direct exposure to sunlight
135. r But when AC power is available the ventilator will automatically select AC power as its operating power source N 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 Never connect your ventilator to an electrical outlet controlled by a wall switch because the power may be inadvertently turned off To be held correctly the AC power cable must be fitted into the cable holder incorporated in the battery access cover and located under the AC power socket Refer to the following instructions Caution 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 Ensure that the AC power cable is in perfect condition and not compressed Do not leave power cables lying on the ground where they risk being stepped on and damaged To prevent accidental disconnection of the AC power cable use the power cable holder Figure 4 1 item 1 that is inserted into the notch Figure 4 1 item 2 of the battery cover follow the instructions on the next page HI Hatt Ld 1 ce Pang Jen He i Figure 4 1 AC Power Cable Holder Puritan Bennett 540 Ventil
136. r to Appendix E Parts and Accessories for more information It is also possible to use the DC auxiliary port cigarette lighter in a car as a power source as Ensure the car s engine is started prior to connecting the ventilator Note e When away from a wall power source or using an external battery carry at least two external battery packs with the ventilator e An alternative means of ventilation should always be available particularly when the patient is in transit or away from wall power e While using the ventilator on external battery power it is vital that a qualified caregiver capable of providing the necessary corrective actions in the event of alarm conditions is present 2 Wee Fe tl Figure 4 5 Connecting the Ventilator to an External DC Power Source Caution 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 Puritan Bennett 540 Ventilator User s Manual 4 5 Installation and Assembly 4 4 To connect the DC power cable to the ventilator proceed as follows 1 Line up the red marker dot on the ventilator s DC power connector with the marker on the DC power cable Figure 4 6 item 1 1 Align the red markers Y dots and or lines before connecting the cable Push in to Connect the 2 DC Power Cable
137. ration required use the double limb circuit LOW EXH VOLUME IF PERSISTS REPLACE VENT Set the Low VTE alarm limit to OFF for exhaled tidal volume or minute volume monitoring ae Replace the patient circuit with an Inappropriate patient circuit appropriate one Expiratory flow sensor not properly Call your customer service representative calibrated or clinician Replace the defective component s and Defective expiratory flow sensor Call your customer service representative or clinician Under the guidance of a Clinician modify Adjustment of the Low VTE level too high the Low VTE level Puritan Bennett 540 Ventilator User s Manual 3 19 Alarms and Troubleshooting Table 3 2 Alarms and Corrective Actions Continued Alarm Message or Possible Reason s For The Alarm Event Corrective Action s Symptom Adjustment of the Low VTI level too high for PSV CPAP PRES A C PRES SIMV and VOL SIMV modes Under the guidance of a Clinician modify the Low VTI level Adjustment of the pressure level not enough to reach the volume required for Under the guidance of a Clinician modify PSV CPAP PRES A C PRES SIMV and VOL the pressure level SIMV modes Patient circuit obstructed or disconnected Clean unblock and or reconnect the patient circuit Inappropriate patient circuit Replace the patient circuit Have a qualified technician replace the defective component s and call your customer service
138. rence menu Battery symbol if the Refer to chapter 3 Operating device is powered by the Parameters for more information internal battery e Audio paused XX symbol if an alarm is currently inhibited e Alarm paused XX symbol if an alarm has been canceled manually and the cause of the alarm remains A Bargraph Status monitored data window 6 Alarm conditions window Displays pressure generation e Ventilation stopped Standby e For Active alarms scrolls during ventilation displays the message PRESS through active alarm I TO START VENTILATION messages in flashing reverse Ventilation on parameters are video monitored and displayed e For Inactive alarms displays e The Inspiratory Effort Detected the last alarm along with its symbol appears adjacent to trigger date and end of event the monitored I E ratio when time the patient actively triggers a Refer to chapter 3 Alarms and breath Troubleshooting for details Figure 2 4 Ventilation Menu Display 2 6 Puritan Bennett 540 Ventilator User s Manual 2 9 Alarm Menu Alarm menu with ventilation on standby Alarm menu when not in standby 4 Puritan Bennett 540 Ventilator User s Manual Title line Displays ventilation mode and the following symbols e Battery if the ventilator is powered by the internal battery e Audio paused X if an alarm is currently inhibited e Alarm paused XX if an alarm has been canceled
139. requency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment Puritan Bennett 540 Ventilator User s Manual Manufacturer s Declaration Table A 21 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 Electromagnetic Immunity Test IEC 60601 1 2 Test Level Compliance Level Environment 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 d 0 35 P Conducted RF 3 Vrms 3 Vrms IEC 61000 4 6 150 kHz to 80 MHz outside 150 kHz to 80 MHz outside ISM bands ISM bands 10 Vrms 10 Vrms inside ISM bands inside ISM bands P 80 MHz to 800 MHz Radiated RF 20 V m per Draft 20 V m per Draft IEC 61000 4 3 Reviewer Guidance for Reviewer Guidance for Ventilators July 1995 Ventilators July 1995 80 MHz to 1 0 GHz 80 MHz to 1 0 GHz 10V m 10V m 1 0 GHz to 2 5 GHz 1 0 GHz to 2 5 GHz d 23 p 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
140. ric patients with a tidal volume lower than 200 ml Table E 2 List of Circuits Double limb patient circuit with exhalation valve 180 cm 5094000 PVC sterile ADULT Double limb patient circuit with exhalation valve 180 cm 5093900 PVC sterile PEDIATRIC Single limb patient circuit with exhalation valve 180 cm 5093600 PVC sterile ADULT Single limb patient circuit with exhalation valve 180 cm 5093500 PVC sterile PEDIATRIC Hudson single limb patient circuit ADULT 1696 Hudson double limb patient circuit ADULT 690 50 Allegiance Cardinal Airlife single limb patient circuit 6463 H08 ADULT Hudson Allegiance Cardinal and Airlife are the property of their respective owners For more information regarding parts and accessories for the Puritan Bennett 540 Ventilator contact your service representative or www puritanbennett com Puritan Bennett 540 Ventilator User s Manual F Glossary AC Power Alternating current Alarm Pause The audible and visual alarms cease and the AN 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
141. riority 3 1 Logs menu 3 3 menu 2 7 NO DATA message 3 3 overview of 3 7 re activating 3 6 resetting 3 5 silencing 3 4 Troubleshooting 3 14 Alarms and troubleshooting 3 1 Alarms utilization 3 1 Alarms ventilation 3 1 CHECK PROXIMAL LINE2 3 8 CHECK SETTINGS 3 8 3 16 CHECK CHANGE EXH VALVE1 3 8 3 9 3 16 Puritan Bennett 540 Ventilator User s Manual Index 1 Index AMBIENT TEMP 3 15 Antibacterial filter 4 1 I Anti static tubes do not use warning 4 1 APNEA alarm message 3 7 3 15 Audible alarms silencing 3 4 B Back panel 2 4 BATT FAULT1 CALL SERVICE alarm message 3 7 3 15 6 4 BATT FAULT2 CALL SERVICE alarm message 3 7 3 15 BATT FAULT3 CALL SERVICE alarm message 3 7 3 15 BATT FAULT4 REPLACE VENT alarm message 3 7 3 15 BATT TEMP FAULT alarm message 3 7 Battery heat safety device 4 1 BATTERY TEMP 3 16 Battery internal capacity 6 1 indicator front panel figure 6 3 operation 6 2 reserve capacity display ventilation running fig ure 6 3 reserve capacity display ventilation stopped fig ure 6 3 reserve capacity displayed 6 2 symbol 6 2 Beep 6 5 Breathing Circuit 4 6 C CAL FAULT 3 7 CALIBRATION FAIL alarm message 3 16 Capacity of the battery 6 1 Carbon dioxide risk of inhalation and suffocation 1 2 1 6 5 4 Cautions definition of 1 1 general list of 1 9 CHECK PROXIMAL LINET alarm message 3 8 3 16 CHECK PROXIMAL LINE2 alarm message 3 8 CHECK SETTINGS alarm message 3 8 3 16 CHECK CH
142. rom any signs of damage and leaks If exhaled volume monitoring is required use the Pass double limb circuit for exhaled tidal volume or minute volume monitoring B 2 Puritan Bennett 540 Ventilator User s Manual C Unpacking and Preparation The Puritan Bennett 540 Ventilator is shipped from the factory with the following items 1 Printed User s Manual 1 Clinician s Manual on CD a print copy is available upon request by the customer 1 Patient circuit and valve in one of the following configurations as requested by the customer e Adult Single Limb e Adult Double Limb e Pediatric Single Limb e Pediatric Double Limb 1 Set of six 6 combination foam fine particle air inlet filters 1 Dual bag 1 Oxygen connector 1 1 AC power cable US version WARNING e Users must always possess an additional breathing circuit and valve while using the Puritan Bennett 540 Ventilator e To minimize the risk of damage you must use the Dual Bag part no 2967200 to transport the e Puritan Bennett 540 Ventilator To unpack and prepare the ventilator follow the steps below 1 From the plastic bag remove the following e Plastic pocket containing the User s and Clinician s Manual e The ventilator and its components and or accessories6 2 Remove the patient circuit the AC Mains power cable and the set of fine particle air inlet filters see Figure C 1 3 Inspect the ventilator and ensure
143. rted into the patient circuit between the main outlet and the patient refer to Figure 4 7 and Figure 4 8 Puritan Bennett 540 Ventilator User s Manual 4 11 Installation and Assembly 4 7 N WARNING J During invasive ventilation the patient s upper airways may become dry and irritated causing discomfort For this reason the use of a humidifier is strongly recommended Always position any humidification device so that it is at a lower height than both the ventilator and the patient Use water traps if necessary to limit water flow towards the ventilator and the patient and periodically empty these water traps If a heated humidifier is used you should always monitor the temperature of the air delivered to the patient Air that becomes too hot may burn the patient s airway Consult with your Customer Support representative before attempting to use a heated humidifier 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 4 12 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 t
144. s The Waveform menu is only accessible when ventilation is active 1 VOL A C an 4 CMH20 PIF T cmH20 PEEP D t e 7 A cMmH20 2 i Km j 3 EN Time E Time elol bpm Title line Graphic zone 3 Numeric zone Displays ventilation mode and the Displays the patient s Displays monitored data following symbols pressure and flow e Battery 4 if the ventilator is waveforms as a function powered by the internal of time battery 2 11 Audio paused 7 if an alarm is currently inhibited Alarm paused XX if an alarm has been canceled manually and the cause of the alarm remains Freeze Waveforms 11 if the tracing of patient waveforms has been halted during ventilation Figure 2 6 Waveforms Menu If Ventilator Failure Occurs Ifa 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 3 Alarms and Troubleshooting If you cannot determine the cause of a problem contact your equipment supplier or Puritan Bennett Puritan Bennett Technical Services USA 1 800 255 6774 Puritan Bennett 540 Ventilator User s Manual 3 Alarms and Troubleshooting N WARNING Setting Alarm limits to extreme values can cause the ventilator alarms
145. s It is essential to read understand and follow these instructions before using the Puritan Bennett 540 Ventilator ISO 7000 0434A This symbol appears on the ventilator s back panel and internal battery see Table 1 2 item 11 Type BF 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 6 Direct current DC IEC 60417 5031 This symbol appears on the ventilator s back panel see Figure 1 4 item 10 Figure 4 5 on page 4 5 This symbol appears on the ventilator s back panel and keyboard see Figure 1 4 item 9 and Figure 2 3 on page 2 5 item 10 x Alternating current AC IEC 60417 5032 Internal Battery This symbol appears on the ventilator s keyboard see Figure 2 3 on page 2 5 item 10 Insulation class Il equipment IEC 60417 5172 mj 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 6 Puritan Bennett 540 Ventilator User s Manual Symbols and Markings Table 1 1 Ventilator Symbols Continued Index of Protection rating for the ventilator s enclosure defined in IEC 60529 BSEN60529 1991 The first digit 3 indicates protection against t
146. s Continued Alarm Message or Possible Reason s For The Alarm Event Corrective Action s Symptom CAUTION Ensure that ventilator is being used according to the operating instructions found in Appendix A 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 tolerance ranges BATTERY TEMPERATURE FAULT Defective internal temperature probe or AN WARNING any other technical anomaly inside the battery In case of operation in a high ambient temperature handle the ventilator with care some portions of the device may have high surface temperatures Call your customer service representative CAUTION Do not attempt to charge a defective battery such a battery cannot be charged Too large a difference between a aot Restart calibration calibration point and its tolerance range Have a qualified technician replace the Defective expiratory flow sensor defective component s and call your customer service representative Obstruction or abnormal damage of the Clean or replace the exhalation valve CHECK exhalation valve and or its control tube EXH VALVE Reconnect the valve or replace the RESTART VENT exhalation valve and or the exhalation valve pilot pressure tube CALIBRATION FAULT Defective connection or defective exhalation valve tubing
147. s refer to chapter 6 Internal Battery The Dual Bag accessory consists of a carrying bag that allows the Puritan Bennett 540 Ventilator to be both mounted onto a wheelchair and carried as a backpack see Figure 4 1 7 Refer to the Dual Bag s instructions for further information NO E N M NN Figure 4 17 Using the Dual Bag Accessory 4 10 Mounting the Ventilator on the Utility Cart Match the mounting holes item 1 on the bottom of the Puritan Bennett 540 Ventilator to the mounting studs item 2 on the top of the utility cart platform Puritan Bennett 540 Ventilator User s Manual Installation and Assembly 4 11 Connecting the Nurse Call Cable Connect the Nurse Call cable Figure 4 18 item 1 to the Nurse Call Monitor Connector item 2 Figure 4 18 Connecting the Nurse Call Cable e Before using the Nurse Call system ensure that its connections are secure and it operates properly For more information contact Puritan Bennett Caution e To connect the Puritan Bennett 540 Ventilator to a nurse call device first contact Puritan Bennett to verify device compatibility and to obtain a suitable connection cable e 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
148. set low VTE alarm limit for all ventilation modes if using a dual limb circuit Puritan Bennett 540 Ventilator User s Manual Installation and Assembly 4 5 WARNING In the SIMV mode we recommend using a double limb circuit and leaving the VTE Min setting active in the event that pressure losses are present on the patient circuit downstream from the proximal pressure link This is because in such cases the PATIENT DISCONNECTION alarm would not be systematically activated in case of a disconnection of the 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 expiratory block for a double limb circuit WARNING e When a nose mask or face mask is used in Non Invasive Ventilation NIV the mask must NOT contain an expiration aperture or exhaust port no leakage e The level of inspiratory resistance of the circuit and accessories bacterial filter humidifier and so on must be as low as possible Settings particularly the LOW PRESSURE DISCONNECT 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 e Resistance o
149. ssion 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 After replacing the ventilator s internal battery push on the battery s cover from the rear towards the front to take pressure off the cover mounting brackets thereby avoiding breakage when the screws are tightened Precautions Regarding Oxygen N WARNING o 1 8 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 excessive oxygen use is likely to lead to serious complications including but not limited to patient injury Strictly follow the instructions provided in section 4 8 2 Connecting the Oxygen Supply which include the use of a flow regulator and special coupler 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 The Puritan Bennett 540 Ventilator does not include an oxygen analyzer Always measure the delivered oxygen with a calibrated oxygen analyzer that features a high and low concentration alarm in order to ensure that the prescribed oxygen concentration is delivered to the patient Ensure that the oxygen supply pres
150. sure to the machine never exceeds 7 25 psi 49 99 kPa or a flow of 15 Ipm Refer to Table A 8 on page A 3 for volume and sensitivity tolerances 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 Air the affected room to bring the oxygen level down to normal The hose connecting the ventilator to the oxygen source must be designed exclusively for 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 Ensure that the only gas supplied to the ventilator through the dedicated oxygen supply connector is medical grade oxygen 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 To prevent any interference with the internal sensors of the ventilator do not install a ventilator humidifier upstream of the ventilator Puritan Bennett 540 Ventilator User s Manual Cautions 1 3 Cautions General Precautions For Use Caution e To ensure proper servicing and avoid the possibility of physical injury to personnel or damage to the ventilator only qualified personnel should attempt to service t
151. t always triggers a final continuous alarm 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 BATT FAULT1 CALL SERVICE 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 Puritan Bennett 540 Ventilator User s Manual Storing the Battery allowed to charge when it not in use and that the ventilator be recharged systematically after storage and before using it again To charge the internal battery do the following Connect the ventilator to the AC power source e The AC POWER indicator illuminates Figure 6 2 item 1 e The INTERNAL BAT indicator flashes Figure 6 2 item 2 INTERNAL BAT FOLLOW INSTRUCTIONS FOR USE Figure 6 2 Power Indicators When Charging the Battery When the battery charge is complete the INTERNAL BAT indicator turns off N WARNING Even if the INTERNAL BAT indicator is off charge
152. t 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 e Ona daily basis ensure the proper connection and operation of the patient circuit e Ifaproblem 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 e 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 e 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 7 1 e Donot attempt to 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 repair or service the ventilator e Ifthe 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 a
153. that the AC POWER DISCONNECTION alarm Is triggered the yellow MP indicator flashes an alarm sounds and an error message Is displayed 7 Ensure that the battery symbol with Its reserve capacity appears and the INTERNAL BAT indicator illuminates 8 Press the ALARM CONTROL key twice to cancel the alarm then stop ventilation using the ON OFF key HANDLING ALARMS When an alarm is activated examine the patient before checking the ventilator Then consult the Alarms and Troubleshooting chapter of the User s manual In most cases 1 You will have to check the entire patient circuit 2 The clinician should verify that the alarm settings are appropriate for the patient For specific alarm situations LOW or EMPTY BATTERY or ON INTERNAL BATTERY Connect the ventilator to AC power or a fully charged external DC power source For technical support call 1 800 255 6774 or visit the SolvITs Center Knowledge Base at www puritanbennett com AC POWER DISCONNECTION Check the power cord and or the power cord connection To obtain service call 1 800 875 8062 or contact your local respresentative 3829200 Rev B 1 Alarms Test Label Figure 1 1 Figure 1 4 A 7 psi max 15 ipm max Va Or O2 INLET lt Q Patient TO PATIENT Press 3 Oxygen Inlet Marking 4 Exhalation Valve and Patient Pressure 2 Patient Gas Inlet Label re Connection Label Figure 1 1 Figure 1 5 Figure 1 4 Figure 1 1 Figure 1 3 g Figure 1 5 Lp AIR INLET PEN
154. tion 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 7 Cleaning Handle the ventilator with care during and after use particularly when room temperatures are high Some ventilator surfaces may become hot even if safety specifications are not exceeded Puritan Bennett 540 Ventilator User s Manual Warnings General Precautions For Installation N WARNING Environment e Because the internal Lithium ion battery of the Puritan Bennett 540 Ventilator contains more than 8g equivalent lithium and has a power rating greater than 100 Wh watt hour it is categorized as Hazardous Material Dangerous Good Class 9 Miscellaneous even though the ventilator meets current safety standards The ventilator because of this categorization is subject to strict transport conditions under the US Department of Transportation US DOT regulations for the transport of hazardous materials 49 CFR 173 185 As US DOT regulations cover commercial transportation only there are two groups that can be exempted from these regulations The first group consists of private individuals providing that the goods are for their own personal use and measures have been taken to prevent leakage T
155. tions under the Dangerous Goods Regulation for air transport IATA Internal Maritime Dangerous Goods code for sea as well as the European Agreement concerning the International Carriage of Dangerous Goods by Road ADR for Europe As ADR regulations cover commercial transport only there are two groups that can be exempted from these regulations The first group consists of private individuals providing that the goods are for their own personal use and measures have been taken to prevent leakage The second group consists of persons that transport the goods because they need the product to execute their job s For any other group or purpose transport must be compliant with Dangerous Goods Regulations In the case of air transport of the ventilator whether as checked or carry on baggage it is recommended that the users ask the carrier which measures to take prior to transport 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 Battery Capacity The reserve capacity offered by the internal battery depends on the level of adjustments made 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
156. topped because a substantial quantity of expiratory 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 You can stop your ventilator at any time regardless of which menu is currently displayed To stop the ventilator proceed as follows 1 Hold down the VENTILATION ON OFF key Figure 5 4 item 1 for about three 3 seconds e A message prompting the user to keep the button pressed appears on the monitoring window as shown in the graphic below VOL A C 04h15 vit 500mL BREER OFF Ramp to R Fate 13 bpm InspTime 1 55 PRESSED FOR Insp Sens 3 3 SEG TO STOP 5 4 Puritan Bennett 540 Ventilator User s Manual Turning Off the Ventilator e While keeping the VENTILATION ON OFF key pressed a new message appears that directs the user to release the key to stop ventilation shown in the graphic below VOL A C 04h15 vi 500 mL PEEP OFF Ramp d ias i i D R Fate 13 bom ity InspTime 1 55 RELEASE er eee FOR COMPLETE Insp Sens 3 STOF Preferences c mHC e A double beep sounds 2 Release the VENTILATION ON OFF key e Ventilation stops e The blue LED located to the upper right of the VENTILATION ON OFF key Figure 5 4 item 2 illuminates to indicate ventilation is on Standby e A prompt for a new start of ventilation is displayed see Figure 5 3 o
157. tor User s Manual Range 30 mL to 1990 mL Resolution 10 mL Default value 300 Depends on High VTE Range 80 mL to 3000 mL Resolution 10 mL Default value 1000 Depends on Low VTE Range 0 5 L to 50 0 L Resolution 0 1 L Default value 4 0 Depends on High Min vol Range 2 0 L to 99 0 L Resolution 0 1 L Default value 13 Depends on Low Min vol Range 10 bpm to 70 bpm Resolution 1 bpm Default value OFF Depends on R Rate Range PIP 20 not adjustable Resolution N A Range PIP 20 not adjustable Resolution N A Range 30 mL to 1990mL Resolution 10 mL Default value OFF Depends on High VTI Range 80 mL to 3000 mL Resolution 10 mL Default value 2000 mL Depends on Low VTI Range 30 mL to 2000 mL Resolution 10 mL Default value OFF Depends on High VTE Range 80 mL to 3000 mL Resolution 10 mL Default value OFF Depends on Low VTE Specifications Table A 11 Ventilator Range Resolution and Accuracy Continued Setting or Monitored Parameter Range Resolution and Accuracy Low Minute Volume Range 0 5 L to 50 0 L Low Min Vol Resolution 0 5 L Default value OFF Depends on High Min vol VTI R Rate High Minute Volume Range 2 0 L to 99 0 L High Min Vol Resolution 0 5 L Default value OFF Depends on Low Min vol VTI R Rate High respiratory rate Range 10 bpm to 70 bom High Rtot Resolution 1 bpm Default value OFF Depends on Backup R Minimum inspiratory time Range 0 1 to
158. ts sold by Puritan Bennett as replacements for internal components may result in increased emissions or decreased immunity of the ventilator A 10 Standards Compliance and IEC Classification General Standards e Medical Electrical Equipment General Requirements for Safety IEC60601 1 1990 and all its amends up to 1996 e The ventilator will be constructed to comply with the following product Classifications as detailed in Clause 5 of 60601 1 Class II Equipment Internally Powered Equipment Type BF Applied Parts IP31 with respect with respect to access to hazardous parts and ingress of moisture Not suitable for use in the presence of flammable anesthetic mixtures Not suitable for sterilization Suitable for continuous operation Detachable power supply cord 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 June 30 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 e Medical Electrical Equipment Part 1 General Requirements for Safety 2 Collateral standard Programmable Electrical Medical Systems IEC 60601 1 4 2000 e Medical Electrical Equipment Part 1 General Requirements for Safety 2 Collateral standard Usabi
159. tt 540 Ventilator User s Manual 1 11 Safety Information Table 1 1 Ventilator Symbols Continued Nurse Call connector This symbol appears on the back panel of the ventilator adjacent to the nurse call connector see Figure 1 4 item 3 and Figure 4 18 on page 4 18 Switch in Off position IEC 60417 5008 This symbol appears on the I O power on off switch on the back panel of the ventilator to indicate the switch s Off position See Figure 2 2 on page 2 4 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 4 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 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 6 item 1 and refer to chapter 6 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 F
160. ty ccc ccc cece cece e eee e ee eneeneees 6 2 Approved Cleaning Solutions for Exterior Ventilator Surfaces 00 00 eee 7 1 Consumables and Replacement Intervals ccc ccc ccc cece ee eee eee cece eeeees 8 2 Physical Description Excluding ACCeSSOIiI S cece ccc cece cece eee e ene eneees A 1 Este ee SUDDIN EE natant nm ET EE PE EE A 1 Internal Lithium lon Battery ccc ccc ccc ee eee e tenn eee eeeeeeeenenes A 2 Remote Alarin eeaeee Hasan Cet eneieeetiiescuroatuie etek antes aniowetliothiines A 2 POWEl INCI G ALON mnene Aesth hc nails lhe eden Ge Ges aw Gatine a same seneesen A 3 Alarm INNES ra ere A 3 PIG ee A 3 Performance Parameter Specifications and Tolerances cece cece eect eees A 3 Volume Performance Test Results uuusssra sn dere a e TaN A 3 Monitored Parameter Specifications and Tolerances 0 0 c cece cece eee eeeee A 4 Ventilator Range Resolution and ACCUraCy cece cece cece e eee e een eeeenee A 5 Environmental Conditions for Storage or Transport ccc cece eee eee ees A 12 Environmental Conditions for Operation cc ccc cece cece cette teen ee eeees A 12 Airway INCSISLANCES seede A 12 Patient Circuit Resistances saarsaaarsskae stars edu d eeee staawsieeedueweads A 12 Air Inlet Resistance Filter esacess shes soe sedeous Miwswcios ENAA eee A 12 Oxygen Inlet Specifications sarsies siron E ccc cee ene cee eee e eee een ene eee eeaes A 12
161. vea leak of the machine qualified technician check them IF PERSISTS REPLACE VENT Have a qualified technician replace the Defective internal pressure sensor defective component s and call your customer service representative DEVICE FAULT1 REPLACE VENT Have a qualified technician replace the defective component s and call your customer service representative DEVICE FAULT3 Replace the ventilator and call your Operating speed of the cooling fan not Replace the ventilator and call your DEVICE FAULT4 REPLACE properly adjusted for the internal ambient customer service representative temperature of the device DEVICE FAULT2 REPLACE Defective proximal pressure sensor or VENT internal leak of the machine VENT DEVICE FAULT5 REPLACE Internal problem in the electrical power Replace the ventilator and call your VENT supply customer service representative DEVICE FAULT6 REPLACE Turbine overheated because of blockage Replace the ventilator and call your VENT during operation customer service representative DEVICE FAULT7 REPLACE Replace the ventilator and call your VENT eee customer service representative Inspiratory flow is constant 1 lpm with DEVICE FAULT8 REPLACE normal turbine temperature and speed Replace the ventilator and call your customer service representative VENT conditions DEVICE FAULT9 REPLACE POST RAM Error RAM Read Write does not Replace the ventilator and call your VENT match memory setting
162. vel too low for PSV CPAP PRES A C PRES SIMV and VOL SIMV modes Adjustment of the pressure level too high for the volume required for PSV CPAP PRES A C PRES SIMV and VOL SIMV modes Leak in the patient circuit Inappropriate patient circuit Defective flow sensor or internal leak in the HIGH INSP VOLUME machine Adjustment of the High Min Vol level too low Leak in the patient circuit Inappropriate patient circuit HIGH MINUTE VOLUME Defective flow sensor or internal leak of the machine Adjustment of High PIP too low only for VOL A C and VOL SIMV modes Airway obstruction Corrective Action s Under the guidance of a Clinician modify the High VTE level Replace the patient circuit Calibrate the expiratory flow sensor refer to section 8 1 Replacing the Air Inlet Filter on page 8 1 Replace the exhalation block and calibrate the expiratory flow sensor see section 8 1 Replacing the Air Inlet Filter on page 8 1 Call your customer service representative Under the guidance of a Clinician and modify the High VTI level Under the guidance of a Clinician and modify the pressure level Check and properly connect the patient circuit Replace the patient circuit Have a qualified technician replace the defective component s and call your customer service representative Under the guidance of a Clinician modify the High Min Vol level Check and properly connect
163. ventilator is connected to an AC supply and the battery is charging INTERNAL BAT indicator is flashing Puritan Bennett 540 Ventilator User s Manual 4 3 Installation and Assembly e Front Panel Keyboard C INTERNAL BAT PURITAN BENNETT 540 Ventilator Figure 4 4 Power Indicators 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 4 4 Puritan Bennett 540 Ventilator User s Manual Connecting to an External DC Power Source 4 3 Connecting to an External DC Power Source N WARNING J The use of the device on an external 12 30 VDC power source does not allow charging of its internal battery Ensure that the internal battery is fully charged before connecting the DC power cable e When using a car auxiliary adapter cigarette lighter ensure the car has been started prior to plugging in the ventilator s DC adapter 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 4 5 item 1 that connects to the ventilator s rear panel DC power input connector Figure 4 5 item 2 The DC power cable is optional refe
164. vice should be used with additional precautions including installation in a cooler location To reduce the risk of fire keep matches lighted cigarettes and all other sources of ignition such as flammable anesthetics and heaters away from the ventilator and its oxygen supply and hoses Even if the INTERNAL BAT charging indicator is off charging of the battery may sometimes be incomplete if the ambient temperature is above 104 F 40 C because of the battery s internal heat safety device Puritan Bennett 540 Ventilator User s Manual 4 1 Installation and Assembly 4 2 Caution The use of any accessory other than those specified by Puritan Bennett may lead to an increase in electromagnetic emissions or a decrease in the equipment s insulation against electromagnetic emissions The Puritan Bennett 540 Ventilator requires special precautions for electromagnetic compatibility and should be installed and started according to the recommendations stated in Appendix A 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 the ventilator s operation 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 ventilato
165. xterior Ventilator Surfaces Continued Glutaraldehyde Cidex or equivalent Hospital disinfectants e Professional Amphyl e Cavicide e Control III Hydrogen sammon esne 7 2 Cleaning the Accessories Follow the accessory manufacturer s instructions for cleaning the ventilator s accessories and components including the patient circuit AN 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 Caution Never use a liquid cleaner inside the patient circuit or on any component of a gas or air pathway 7 2 Puritan Bennett 540 Ventilator User s Manual 8 Routine Maintenance N WARNING e Ona DAILY basis inspect the patient circuit to ensure that it shows no signs of damage is properly connected and is operating correctly without leakage e Donot attempt to 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 repair or service the ventilator 8 1 Replacing the Air Inlet Filter N WARNING e 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 whe
166. y AC mains power source cut off cable and or the effective a of a voltage on the AC power mains port AC POWER DISCONNECTION a d a a Powel Cancel the alarm Current limiting fuse of the device blown Replace ne ventilator and call for the maintenance technician Puritan Bennett 540 Ventilator User s Manual Table 3 2 Alarms and Corrective Actions Continued Alarm Message or Possible Reason s For The Alarm Event Corrective Action s Symptom AMBIENT TEMP ALERT Internal ambient temperature of the device out of the tolerance ranges Troubleshooting CAUTION Ensure that you are operating the ventilator within the proper temperature range refer to Appendix A 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 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 AN WARNING In the case of high ambient temperatures 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 106 F 41 C If in doubt replace the ventilator AMBIENT TEMP Defective internal temperature probe or Replace the ventilator and
167. ype 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 E 2 List of Circuits on page E 2 for a list of recommended patient circuits e Resistance of the exhalation valve and accessories water traps filters and so on 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 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 540 Ventilator e Consult with your Customer Support representative before attempting to use a heated humidifier e 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 e Ifaheated humidifier is used you should always monitor the temperature of the air delivered to the patient Air 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

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