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BREAS PV 403 PEEP

1. If you have changed the ventilation mode always check the settings and perform a complete function test see the chapter Complete function check on page 49 You must adjust all applicable settings for each of the PSV PCV or VCV modes that are to be used by the patient see the table matrix below Applicable setting PCV mode PSV mode VCV mode Pressure X X Rate X X X Inspiration time X X Inspiration trigger X X X Plateau X X Expiration trigger X Tidal volume X PEEP X X X a The setting parameter is active for 5 seconds after the latest press on a button Thereafter the parameter must be reselected in order to be adjusted Locking unlocking the settings panel The lock function is used for locking the settings panel to prevent accidental changes to the settings When the settings panel of the PV 403 PEEP is locked only the On Off but ton is active The settings panel should normally be locked when the ventilator is used away from the clinic BREAS MEDICAL Doc No 003 176 En Issue X 1 Operating Manual PV 403 PEEP Setting the PV 403 PEEP 9 2 9 3 9 4 When the lock function is activated the Lock function LED on the settings panel shows a green light To lock unlock the settings panel Press and hold down the and buttons on the settings panel for 5 seconds Selecting the ventilation mode The ventilator always starts in the mode that was active when it was switched off To sele
2. Press the Function button on the settings panel OO The muted alarm LCD is lit and the audible alarm remains muted for 1 minute Power failure alarm The power failure alarm is alerted if the internal battery voltage drops below21 2 V for more than 15 seconds during operation or if you try to start the ventilator without any power source connected and the internal battery is faulty or discharged The following are the alarm levels for power failure Internal battery 21 2 V The power failure alarm is indicated as follows The red alarm LED for power failure is lit A continuous audible alarm is given A message about low voltage is displayed on the LCD display depending on the current power source Doc No 003 176 En Issue X 1 BREAS MEDICAL Page 43 Alarm 10 3 Operating Manual PV 403 PEEP The audible alarm and alarm indicator LED may continue for 5 minutes without any power source available The PV 403 PEEP will then automatically switch to standby mode for low current consumption To stop the alarm 1 Switch off the ventilator using the On Off button 2 Restore the mains power supply battery back up source Alarm for low pressure The alarm for low pressure is activated if the set alarm level for low pressure is not reached within 15 seconds This can be due to leakage from the mask or any component of the patient circuit and or the tidal volume being too low When the alarm for low pressure i
3. In case of facial surgery the ventilator shall not be used with a nasal mask After abdominal surgery cautious use of ventilatory therapy is necessary because of pressure changes transmitted to the abdomen Doc No 003 176 En Issue X 1 BREAS MEDICAL Page 5 Introduction 1 3 Page 6 Operating Manual PV 403 PEEP About this manual n Read this manual before setting up and using the PV 403 PEEP to ensure cor rect usage maximum performance and serviceability This manual is primarily intended for care providers clinical personnel doctors and oth ers who require a working knowledge of the PV 403 PEEP However the chapter Patient instructions BREAS ventilator PV 403 PEEP on page 76 is intended for the end user Icon In thi Service personnel may order the BREAS PV 403 PEEP Service Manual which contains detailed service and repair information such as technical instructions cal ibration data electrical diagrams component lists and so on It also contains infor mation on the installation and maintenance of accessories S s manual icons are used to alert you to specific information The meaning of each icon is explained in the table below Icon Type of Explanation information Note A note provides information that is not of critical impor il tance but may nevertheless be valuable such as tips and tricks Warning A warning is used when there is a risk of personal injury D
4. Operating Manual PV 403 PEEP Setting the PV 403 PEEP Breaths per minute 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 22 24 26 28 30 32 34 36 38 0 51 1 19 41 16 1 14 1 12 1 11 1 10 19 18 18 17 17 1 6 16 15 15 14 14 14 13 13 13 13 12 1 2 0 6 1 16 1 13 1 12 1 10 1 9 1 8 17 17 16 16 15 15 15 14 14 14 13 13 13 12 1 2 119 1 18 1 16 0 7 1 13 1 11 1 10 1 9 1 8 1 7 1 6 1 6 1 5 1 5 1 4 1 4 14 14 13 13 13 1 2 1 2 11 9 1 1 7 1 1 5 1 1 4 1 1 3 a 0 81 1 12 1 10 1 8 1 7 1 7 1 6 1 5 1 5 1 4 1 4 14 13 13 13 13 1 2 1 2 1 19 1 1 7 1 1 5 1 1 3 1 12 1 1 1 c 9 0 9 1 10 1 9 1 7 16 16 15 15 14 14 13 13 13 13 13 12 12 1 18 1 1 6 1 1 4 1 1 2 1 1 1 o A100 1 9 1 8 1 7 1 6 1 5 1 4 14 14 13 13 1 3 1 3 1 2 1 22 1 2 121 7 1 1 5 1 1 3 1 1 1 1 1 0 1 2 1 7 1 6 15 15 14 14 13 13 13 1 2 1 2 1 19 1 1 8 1 1 6 1 1 5 1 1 3 1 1 1 5 1 5 1 6 1 5 14 13 13 13 1 22 1 2 1 1 9 1 1 7 1 1 5 1 1 4 1 1 2 1 1 1 1 1 0 2 2 0 1 4 1 3 1 3 4 2 1 2 1 1 7 1 1 5 1 1 3 1 1 1 1 1 0 2 5 1 3 1 2 1 2 1 1 7 1 1 4 1 1 2 1 1 0 3 01 1 2 1 19 1 15 1 12 1 1 0 4 0 1 1 5 1 1 4 1 1 1 4 5 1 1 2 1 11 5 0 1 1 0 9 7 Incorrect settings for rate and inspiration time If the set values for inspiration time and rate are outside the ventilator s working range and cannot be achieved the Rate and Insp Time LEDs will flash as a warning In the PSV mode only the Rate LED will flash if the patient triggers too many breaths To stop the warning indicatio
5. S I A J1 J2 Page 70 BREAS MEDICAL Doc No 003 176 En Issue X 1 Doc No 003 176 En Operating Manual PV 403 PEEP Technical specifications 16 3 Compliance of Standards Standard Specification IEC 60601 1 1988 Medical electrical equipment Part 1 General require Al 1991 ments for safety A2 1995 IEC 60601 1 1 2000 Medical electrical equipment Part 1 1 General requirements for safety Collateral standard Safety requirements for medical electrical systems IEC 60601 1 2 2001 Medical electrical equipment Part 1 2 General requirements for safety Collateral standard Electro magnetic compatibility requirements and tests IEC 60601 1 4 2000 Medical electrical equipment Part 1 4 General requirements for safety Collateral Standard Program mable electrical medical systems IEC 60601 1 8 2003 Medical electrical equipment Part 1 8 General requirements for safety Collateral standard Alarm systems requirements tests and guidelines ISO 10651 2 2004 Lung Ventilators for Medical use Particular require ments for basic safety and essential performance Part 2 Home care ventilators for ventilator dependent patients ISO 10651 6 2004 Lung ventilators for medical use Particular require ments for basic safety and essential performance Part 6 Home care ventilatory support devices ISO 17510 1 2001 Sleep apne
6. Patient instructions BREAS ventilator PV 403 PEEP on page 76 Perform a complete function check if you have changed the ventilation mode or if you need to control the ventilation function for any other reason see the chapter Complete function check on page 49 Doc No 003 176 En Issue X 1 BREAS MEDICAL Page 21 Using the PV 403 PEEP Operating Manual PV 403 PEEP 4 8 To monitor the exhaled volume If you want to check the tidal volume using a volume monitor you need an exhalation valve with a PEEP valve connector Connect the volume monitor to the PEEP valve out let on the exhalation valve outlet KK PEEP ee Volume monitor Fig 2 a Checking the tidal volume Page 22 BREAS MEDICAL Doc No 003 176 En Issue X 1 Operating Manual PV 403 PEEP Using a battery supply 5 5 1 5 2 5 3 Using a battery supply This chapter describes the use of external and internal battery back up sources for the PV 403 PEEP D The additional battery supply of the PV 403 PEEP must be controlled and or replaced regularly when used as a back up power source Power source priority The PV 403 PEEP automatically selects the power source as follows if both mains power and battery power are available 1 2 Normally the mains supply is selected first The external battery source is selected if no mains supply is connected or if the main
7. The ventilator will switch over to the internal battery supply in case the battery voltage drops below 21 2 V 10 6 V during operation Using an internal battery The PV 403 PEEP is equipped with a 24 V 3200 mAh internal battery as a back up power source Operating time The operating time of the internal battery depends on the settings enviromental condi tions and the patient s physiological characteristics Examples of battery operating time at 25 degrees Celcius with a new and fully charged internal battery Setting 1 Parameter Value Result Mode PCV Pressure 30 mbar Rate 12 BPM Insp time 2 0 Sec Insp trig OFF Plateau 5 Exp trig 30 Volume appr 700 ml PEEP OFF Operating time 10 hours Setting 2 Parameter Value Result Mode PCV Pressure 50 mbar Rate 20 BPM Insp time 2 0 Sec Insp trig OFF Plateau 9 Exp trig 30 Volume appr 600 ml PEEP 5 mbar Operating time 4 hours BREAS MEDICAL Doc No 003 176 En Issue X 1 Operating Manual PV 403 PEEP Using a battery supply Setting 3 Parameter Value Result Mode PCV Pressure 18 mbar Rate 8 BPM Insp time 2 0 Sec Insp trig OFF Plateau 5 Exp trig 30 Volume appr 200 ml PEEP 5 mbar Operating time 15 hours Low battery voltage The ventilator will start the low battery alarm if the battery voltage drops below 23 3 V during operation D Doc No 003 176 En Issue X 1 The ventilator will start the power failure
8. or equipment damage Moreover it is used when you may risk losing data getting an unexpected result or having to redo part of a procedure Reference A reference guides you to other manuals where you will find additional information on a specific topic BREAS MEDICAL Doc No 003 176 En Issue X 1 Operating Manual PV 403 PEEP Safety precautions 2 Safety precautions This chapter lists all safety precautions for the PV 403 PEEP Furthermore the safety symbols on the equipment designation label are described General Do not use the PV 403 PEEP for any other treatment than the intended use recom mended by BREAS Clinic personnel and the end user must read this operating manual and understand how the PV 403 PEEP is used before setting up and using the apparatus The PV 403 PEEP may be used for total life support provided that emergency equipment resuscitation bag is available and either an external battery and or an internal back up battery pack is installed The battery supply serves as a back up power supply if the mains power supply fails or is disconnected For more informa tion see the chapter Using a battery supply on page 23 Adjustment of settings should always be based on medical advice and must be car ried out by authorised clinic personnel only Blood gas measurement shall be per formed when changing settings or changing to another device All the patient alarms of the PV 403 PEEP must be set at
9. Manual PV 403 PEEP Alarm o The low pressure alarm must be set for the exact configuration of the patient circuit components If you add remove or change components readjust the low pressure alarm n The low pressure alarm level is recommended to be set at a level below the set pressure that will effectively warn the user of any disconnection or loss of pres sure in the patient circuit This should be assessed in accordance with the patient s needs To set the alarm level for low tidal volume 7 Press the Function button until the Volume LED is lit 8 Adjust the setting using the and or button Setting range 0 05 to 1 4 litres To exit the alarm setting 9 To exit press the Function button until the QUIT LED is lit Press the button to quit The value of the alarm level is automatically saved when you quit or when the display switches back to the standard setting display 10 10 Setting the alarm levels in VCV mode In the VCV mode you should set the alarm levels for high and low pressure and high rate If you have started the alarm setting procedure and do not press any button within 10 seconds the display will return to the standard display Press the Function but ton once to return to the alarm setting function To start the alarm setting 1 Press the Alarm set button on the settings panel PRESSURE ALARM so mbar The display will change as shown in the figure RATE SET BPM 2 Select Ye
10. No Remarks Page 64 BREAS MEDICAL Doc No 003 176 En Issue X 1 Operating Manual PV 403 PEEP 16 Doc No 003 176 En Technical specifications Technical specifications The technical specifications of the PV 403 PEEP are listed in the tables below This chapter also contains detailed descriptions of the analog digital connector and the alarm output connector of the PV 403 PEEP Setting ranges performance Specifications Modes PSV Pressure Supported Ventilation PCV Pressure Controlled Ventilation VCV Volume Controlled Ventilation Patient pressure 6 50 mbar tolerance 10 of set value Rate 4 40 breaths per minute BPM tolerance 10 of set value Inspiration time 0 5 5 seconds tolerance 10 of set value Inspiration trigger 2 to 8 mbar tolerance 10 of set value Pressure plateau Adjustable tolerance 10 of set value Expiration time 10 50 of max flow tolerance 10 of set value Tidal volume 0 3 1 6 litres tolerance 10 of set value PEEP 0 10 mbar tolerance 2 mbars Minute volume 2 50 l min tolerance 10 Maximum flow 120 l min tolerance 10 Maximum limited pressure during single fault condition 60 mbar Display Output Specifications Patient pressure 0 50 mbar tolerance 4 of max value and 8 of actual value Delivered tidal volume 0 1 1 6 litres
11. PEEP LEDs will flash as a warning that is followed by the low tidal volume alarm To stop the warning indication 1 Press the Function button until the Pressure or PEEP LED is lit DoE 20 eo INSP TIME os 3 3 5 Sec 2 Press the buttons to adjust the settings for INSP TRIG orr 2 0 5 s mbar pressure or PEEP PRESSURE 15 50 mbar PLATEAU L Born EXPTRIG 1 so VOLUME o 0 75 6 Litres POWER M 10 PEEP Page 42 BREAS MEDICAL Doc No 003 176 En Issue X 1 Operating Manual PV 403 PEEP Alarm 10 10 1 10 2 Alarm This chapter describes the alarm functions used for the PV 403 PEEP and how to adjust the alarm levels for each ventilation mode The alarm function of the PV 403 PEEP consists of the alarm LEDs on the settings panel an audible alarm and for some alarm functions messages on the LCD display The following alarms are used by the ventilator f ALARM POWER e Power failure alarm nen RE SET VOLUME Alarm for low pressure RATE e Alarm for high pressure BATTERY Alarm for low tidal volume Alarm for high rate Alarm for low battery e Function error alarm Audible alarm You can adjust the audible alarm to a suitable sound level The audible alarm can be muted for low pressure low tidal volume and high rate Adjustment To adjust the alarm sound level K screw Adjust the screw on the ventilator s rear panel using a screwdriver ee To mute the audible alarm OOO
12. The front panel of the PV 403 PEEP is shown in the illustration below Front connectors The table below describes the connectors of the front of the PV 403 PEEP Operating Manual PV 403 PEEP No Connector Function 1 Patient air outlet Used for connecting the ventilator to the patient tube Diameter 22 mm ISO cone male 2 Exhalation valve Used for connecting the white control tube to the exhalation connector valve Diameter 4 mm tube 3 Pressure measuring Used for connecting the green pressure tube to the exhala connector tion valve Diameter 3 mm tube BREAS MEDICAL Doc No 003 176 En Issue X 1 Operating Manual PV 403 PEEP 3 3 Settings panel Main components and panels The user controls and the LEDs on the settings panel that is located on the top of the PV 403 PEEP are shown in the illustration below PRESSURE 1 PPP rrrirrirrirrirrrrrrrrrriritridid 10 20 30 40 mbar cmH20 2 3 J A PRESSURE so mbar B RATE 4 2 BPM 6 C INSP TIME os s N Sec D INSP TRIG orr 2 e mbar 7 E PLATEAU L nm xX F EXP TRIG 10 s RD G VOLUME o 16 Litres H POWER PEEP 3 8 POWER ALARM PRESSURE 9 4 SET VOLUME A RATE psv MA BATTERY 5 PCV VCV 10 o b Doc No 003 176 En Issue X 1 BREAS MEDICAL Page 13 Main components and panels Operating Manual PV 403 PEEP User controls and indicator LEDs The table below describes the user controls
13. an e Check the low tidal volume alarm audible alarm is given after 15 seconds only in the PSV and PCV modes The low tidal volume alarm should be reset once the pressure reaches the alarm level 5 e Check that the air inlet in the filter cassette at Replace the filter after 500 operating hours or the rear of the ventilator is not blocked more often if needed for example in high e Check the filter pollution environments see page 56 in the operating manual 6 e Block the tube when the ventilator delivers an Instructions on how to perform a leakage test inspiration Check by listening that there is no leakage from the patient circuit Make sure that all hoses are connected prop erly If a mask is used perform a leakage test of the mask after the mask has been fitted of the mask should be given by the doctor depending on what type of mask is used Page 76 BREAS MEDICAL Doc No 003 176 En Issue X 1 Operating Manual PV 403 PEEP Patient instructions BREAS ventilator o If the alarm indication FAIL is shown on the display and an audible alarm is heard switch off the ventilator and then on again If the fault persists call for service personnel immediately and do not use the ventilator At the slightest doubt about the ventilator operating incorrectly always contact the medical staff Cleaning the ventilator The responsible clinic must always instruct on how to best clean the patient circuit and m
14. and LEDs on the settings panel of the PV 403 PEEP No User controls Function indicator LEDs 1 Patient pressure Used for displaying the current patient pressure measured meter at the exhalation valve 2 LCD display Used for controlling various settings and functions of the PV 403 PEEP see the following table 3 Setting buttons User control used for e checking the voltage of the current power source e locking the settings panel increasing and decreasing the value of the selected setting parameter e adjusting the alarm levels for low and high pressure high rate and low tidal volume e setting the actual date and time 4 Alarm set button Used for displaying and setting the alarm levels for high and low pressure high rate and low tidal volume 5 Mode button Used for displaying and setting the active ventilation mode PCV PSV or VCV mode 6 Muted alarm LED Indicates that the audible alarm is temporarily muted 7 Function button User control used for e lighting the background illumination of the LCD display e selecting the setting parameters to be adjusted e displaying the actual date and time e muting the audible alarms for low pressure low tidal volume and high rate 8 Lock function LED Used for indicating that the settings panel of the PV 403 PEEP is locked green light 9 Alarm indicator Used for activating the alarm settings panel The alarm LEDs lights as follows High priority alarms re
15. arrow in pressure field in LCD display Low tidal volume Red flashing LED high priority audible alarm High rate Yellow flashing LED medium priority audible alarm Low battery Yellow flashing LED medium priority audible alarm Function error Continous audible alarm fault code on LCD display Dimensions Weight Specifications Dimensions WxHxD 350x175x260 mm BREAS MEDICAL Doc No 003 176 En Issue X 1 Operating Manual PV 403 PEEP Technical specifications Dimensions Weight Specifications Weight 5 5 kg Doc No 003 176 En Issue X 1 BREAS MEDICAL Page 67 Technical specifications Operating Manual PV 403 PEEP 16 1 Analog Digital output connector A D sub 25 pin female connector is provided in the rear panel of the ventilator for ana log and digital communication It is used for connecting the PV 403 PEEP to a PC when downloading patient data for analysis Follow the instructions below when using the output connection Only use BREAS cables for the connection Accessory equipment connected to the analog or digital interface must be certified according to the respective IEC standards for example IEC 950 for data processing equipment and IEC 601 1 for medical equipment Furthermore all configurations shall comply with the valid version of the system standard IEC 601 1 1 Everybody who connects additional equipment to the signal input part or signal output part
16. extemal DAtlery ns HS NE NS Ne 23 5 4 Using an internal battent votent Neue tons 24 6 Using a humidifier with the PV 403 PEEP aaaaasnnnnnnnnnnnnnnnnnn 26 6 1 Humidification devices Le nd dennenn de dan QUE 26 6 2 Placing a heated humidifier lt s sense nement s 26 6 3 Connecting the humidifier En nee 26 7 Supplying OXygen sssssssssssnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn nnmnnn nnmnnn nnna 27 7 1 OXY EM SOURCE ia RU ARR A cece E rales Maen aat 27 7 2 OXY BET MOMON Asror ero teo EEO CAE AER 27 7 3 Pressure DORE Wiad ete TE ne nine 27 74 Connecting the oxygen Supply cecccieiseacioc sd atcedaareereacenimedadtseiates 28 7 5 Adjusting the tidal volume and the oxygen flow VCV mode 29 8 Ventilation modes and parameters 30 8 1 Setting parameter Snoot eaen re Rise Aes 30 8 2 PCV mode Pressure Control Ventilation cc0ccececeeeeeeeeeeees 32 8 3 PSV mode Pressure Support Ventilation 0 0 0 0 ecceeeeeseeeeseeeeeneeees 33 8 4 Comparing PCV and PSV modes saine ists nr te not see see 34 8 5 VCV mode Volume Control Ventilation cccccccceeeeeeeeeeeees 35 Doc No 003 176 En Issue X 1 BREAS MEDICAL Page 1 Table of contents Operating Manual PV 403 9 Setting the PV 403 PEEP ccsscecseeeseeeeeeeeeeeeees 36 9 1 Locking unlocking the settings panel ceesceeesseceeseeeeeeteeeeeneeeees 36 9 2 Selecting the ventilation mode rnmememendetnunaetotins 37 9 3 SCENE
17. for high pressure is activated if the actual patient pressure reaches the set alarm level When the alarm for high pressure is alerted the following happens The red alarm LED for pressure flashes Page 44 BREAS MEDICAL Doc No 003 176 En Issue X 1 Operating Manual PV 403 PEEP Alarm 10 5 10 6 10 7 The high priority alarm signal is given On the LCD display a flashing up arrow is shown in the pressure field The alarm is reset once the pressure drops below the alarm level The ventilator bellow returns to its end position and a new inspiration is started when the expiration phase of the previous breath has finished or when a breath is triggered by the patient Alarm for low tidal volume The alarm for low tidal volume is activated if the delivered tidal volume does not reach the alarm level within 15 seconds The alarm is only used in the PSV and PCV modes When the alarm for low tidal volume is alerted the following happens The red alarm LED for volume flashes The high priority alarm signal is given The alarm is reset once the tidal volume reaches its set value again Alarm for high rate The alarm for high rate is activated if the patient hyperventilates or if the ventilator starts to self trigger because of incorrect settings The alarm is alerted if the actual rate exceeds the alarm level for more than 15 seconds The delivery setting for the alarm for high rate is Off As the use of th
18. of pressure in the patient circuit This should be assessed in accordance with the patient s needs To exit the alarm setting 9 To exit press the Function button until the QUIT LED is lit Press the button to quit The value of the alarm level is automatically saved when you quit or when the display switches back to the standard setting display Page 48 BREAS MEDICAL Doc No 003 176 En Issue X 1 Operating Manual PV 403 PEEP 11 11 1 D Complete function check Complete function check This chapter describes the complete function check of the PV 403 PEEP This function check should be performed after changing the ventilation mode or if the ventilator func tion needs to be checked for any other reason For information on the short function check which should be performed once a day see the chapter Patient instructions BREAS ventilator PV 403 PEEP on page 76 You must perform all checks for each of the PSV PCV or VCV modes that are to be used by the patient see the table matrix below Function check PCV mode PSV mode VCV mode Low pressure alarm Inspiration Exhalation High pressure alarm Inspiration trigger Expiratory trigger Tidal volume Low tidal volume alarm High rate alarm if used PEEP Power failure X X X X X X X X X X X X X X X X X X X X X X X X X X X X If anything is unclear or if there are doubts perform a new function check reading the description for e
19. safe levels that will effec tively warn the user of any incident The alarm levels should be assessed consider ing the patient settings and the exact configuration of the patient circuit components Any change of settings or components may require the readjustment of the alarm levels Do not use an autoclave to sterilise the PV 403 PEEP Always perform a function check before use see page 21 If the PV 403 PEEP is used continuously 24 hours a day it must be switched off and on again once a day while connected to the power source mains supply exter nal battery or internal battery This is necessary in order for the PV 403 PEEP to perform a self test If the electronics fail the PV 403 PEEP cannot deliver a pressure higher than 60 mbar at single fault condition To ensure maximum operational reliability the PV 403 PEEP must be serviced at the specified intervals by authorised service personnel Environmental conditions Do not use the PV 403 PEEP in environments where there are explosive gases or other flammable anaesthetic agents present Do not place the ventilator so that the air inlet at the rear can be blocked Do not use the PV 403 PEEP when placed in direct sunlight Doc No 003 176 En Issue X 1 BREAS MEDICAL Page 7 Safety precautions Operating Manual PV 403 PEEP The performance of the ventilator and the treatment of the patient may deteriorate if the operation conditions are not fulfilled see the chapter Te
20. tHepressUi enecens 37 9 4 Setting th falee ei nie iE E EEE E E 37 9 5 Setting the inspiration time Insp Time 38 9 6 VE Ratio able sainte iranienne enr 38 9 7 Incorrect settings for rate and inspiration time 39 9 8 Setting the inspiration trigger Insp Trig 39 9 9 SELENE the plateia rere Cer helen ctey aut E A EE ORN 40 9 10 Setting the expiratory trigger Exp Trig seseessesssesssserssssressesesssees 40 9 11 Setting the tidal volume ve nie MM sean anale es 41 9 12 Incorrect settings for rate and tidal volume s nsosssseseseeeesssesseresssee 41 9 13 Setting the PEEP Gun COM name benne 42 9 14 Incorrect settings for pressure and PEEP cc eeeeeceesseceesteeeeeeees 42 a E en ets 43 10 1 Audible Alaris nesinu aene a e Eaire 43 102 _ Power lire ss iniret praterie pe iea e 43 10 3 Alarm for low pressure sa sii Apacs a tae ees 44 10 4 Alarm for high pressure israel datent 44 10 5 Alarm for low tidal Volume cessesacsteveteyassereressceyieansaevestesoseneedsnuntoseees 45 10 6 Alarm for high Pate sentent tenir deedenes 45 TOF LOW DATENT eas ae i Sealed aa Vac dieters toate ne 45 10 8 Function error alarm s ssciasoscssa nied cis has chairs Ewa Ares 46 10 9 Setting the alarm levels in PSV and PCV modes eceeeeeeeeeeees 46 10 10 Setting the alarm levels in VCV mode ceesseceeeeeeeeeeeee
21. the apparatus For detailed instructions on how to set the PV 403 PEEP for the patient see the chapter Setting the PV 403 PEEP on page 36 Ventilation modes The following ventilation modes can be selected for the PV 403 PEEP PCV mode Pressure Control Ventilation PSV mode Pressure Support Ventilation VCV mode Volume Control Ventilation The modes are described in detail in the following sections Setting parameters All the parameters that are used for controlling the breathing by the PV 403 PEEP are listed below Pressure The pressure parameter is used for defining the patient s airway pressure during the inspiration phase measured at the exhalation valve on the patient circuit or Y piece if used This setting is used in the PCV and PSV mode Rate The rate setting corresponds to the patient s breathing rate expressed as the number of breaths per minute BPM The ventilator gives the set number of breaths plus any trig gered breaths Inspiration time Insp Time The inspiration time parameter controls the length of each inspiration This setting is used in the PCV and VCV mode Plateau The plateau parameter sets the speed at which the pressure increases to the desired value This setting is used in the PCV and PSV mode The setting has 9 steps where 1 is the lowest and 9 is the highest A low setting will give a slow increase and therefore a shorter plateau A higher setting will give a fa
22. the patient s airway pressure during the exhala tion phase If the PEEP function is activated the ventilator lets the patient exhale until the set PEEP value is reached When the pressure in the patient circuit is equal to or lower than the set PEEP value the exhalation valve closes The ventilator does not compensate for a lower expiratory pressure caused by leakage Therefore make sure the patient circuit and mask are not leaking o Do not use the internal PEEP function together with an external PEEP valve on the patient circuit Doc No 003 176 En Issue X 1 BREAS MEDICAL Page 31 Ventilation modes and parameters Operating Manual PV 403 PEEP 8 2 PCV mode Pressure Control Ventilation In the PCV mode the ventilation is controlled by the PV 403 PEEP This is done by the pressure rate inspiration time and plateau settings An inspiration is started either when the set rate starts a breath or when the patient trig gers a breath if the trigger function is activated The ventilator tries to reach and main tain the set pressure until the expiration starts The inspiration stops and an exhalation starts in three cases e The inspiration time expires The bellows reaches its end position The limit for the high pressure alarm is reached The figure below shows how the pressure plateau and inspiration time settings control the ventilator s function in the PCV mode The following settings have been used Pressure
23. the trigger is not used by the patient it is recommended to set the trigger function to Off so that the patient cannot trigger any extra breaths o In the range 0 to 8 mbar there is a risk of the ventilator self triggering To set the inspiration trigger RATE a 10 BPM 1 Press the Function button until the Insp Trig INSP TIME os 1 8 5 Sec LED is lit ae M ee INSP TRIG orr 0 5 s mbar The current inspiration trigger setting is dis played PLATEAU L E amp L 2 Press the buttons to decrease increase the aaa 7 setting if required If you want to turn off the inspiration trigger press the button repeatedly until Off is displayed Setting the plateau The plateau parameter is used for setting the speed at which the set pressure increase is reached This setting is used in the PCV and PSV mode As the increase is experienced differently by each patient it should be adjusted to give each patient the best possible breathing comfort Setting range 1 to 9 To set the plateau INSP TIME os 1 8 5 Sec 1 Press the Function button until the Plateau LED INSP TRIG orr0 5 3 mbar is lit oe PLATEAU ai The current plateau setting is displayed EXP TRIG 1 77 50 2 Press the buttons to decrease increase the setting if required Setting the expiratory trigger Exp Trig The expiratory trigger setting is the set percentage of the maximum inspiration flow at which the inspiration phase shoul
24. ventila tor s function in the VCV mode The following settings have been used Volume 1 0 litre Inspiration time 1 8 seconds Volume litres 1 0 Tidal volume setting Start of breath seconds Flow 100 The set tidal volume is reached Patient exhales seconds Doc No 003 176 En Issue X 1 BREAS MEDICAL Page 35 Setting the PV 403 PEEP Operating Manual PV 403 PEEP 9 9 1 Page 36 Setting the PV 403 PEEP This chapter describes how to set the different parameters that are used for controlling the ventilation of the PV 403 PEEP It is only intended for clinic personnel The ventilation modes and setting parameters are described in detail in the chapter Ven tilation modes and parameters on page 30 For information on how to set the alarm lev els for the PV 403 PEEP see the chapter Alarm on page 43 o Adjustment of settings should always be based on medical advice and must be carried out by authorised clinic personnel only Any adjustment of settings may require readjustment of the alarm levels Follow the instructions below when setting the PV 403 PEEP Adjust the settings to find the best possible breathing comfort for each patient Always measure the blood gases during the set up period and when the settings have been changed Always document the set values before the patient returns home Do not change the ventilation mode when the patient is connected to the apparatus
25. well above this HME generated pressure To connect a heated humidifier Follow the manufacturer s instructions 0 The use of an HME or a heated humidifier may require readjustment of the PV 403 PEEP s low pressure alarm see page 44 o When using a heated humidifier condensation may form in the patient circuit over time Periodically check for moisture in the patient circuit When present remove the moisture Before attempting to dry the circuit disconnect it from the ventilator The frequency at which these checks must be performed will depend on the patient s own condition and the device used You should assess this on an individual basis in accordance with the patient s needs If the condensation in the patient circuit is excessive the use of a heated humidifier may require the installation of a water trap in the circuit The water trap prevents any condensated water in the patient circuit from run ning into the patient airways and causing personal injury BREAS MEDICAL Doc No 003 176 En Issue X 1 Operating Manual PV 403 PEEP Supplying oxygen 7 7 1 7 2 7 3 Supplying oxygen This chapter describes how to connect the PV 403 PEEP to an additional oxygen source Oxygen can be supplied to the patient circuit if the oxygen level of the inspiration air needs to be increased o Do not smoke in a room where oxygen is being used n Precautions must be taken when using oxygen as its presence can speed
26. 15 mm 13 cm length 000 278 Exhalation valve PV 403 PEEP PV 401 BREAS 000 486 Oxygen adapter PV 403 PEEP disposable 000 256 Adapter 22 22 15F 000 250 PEEP adapter for exhalation valve BREAS 000 521 Diaphragm kit exhalation valve 000 518 External pressure limiter 5 50 mbar 000 229 Arm for patient circuit including mount table mounting 000 273 Nylon carry bag PV 403 PEEP PV 401 003317 Ventilator trolley VB 301 000 259 Filter LF 403 5 pcs package disposable 001 428 Battery cable BK 524 12 24 V DC 001 508 EB 2 External battery pack 24 V including cable charger and 000 538 bag Filter grey foam rubber 3 pcs package 001 445 Communication cable for Calendar Data software 001 488 PV 403 PEEP Communication cable for Calendar Data software 001 980 all BREAS ventilators Doc No 003 176 En Issue X 1 BREAS MEDICAL Page 73 Patient settings BREAS PV 403 PEEP Operating Manual PV 403 PEEP Va de Page 74 Patient settings BREAS PV 403 PEEP Patente 5252 51 ne nn ae tnt Mode PSV PRESSURE RATE INSPIRATION TIME INSPIRATION TRIGGER PLATEAU A EXPIRATORY TRIGGER TIDAL VOLUME PEEP LOW TIDAL VOLUME ALARM LOW PRESSURE ALARM HIGH PRESSURE ALARM HIGH RATE ALARM BREAS MEDICAL Doc No 003 176 En Issue X 1 Operating Manual PV 403 PEEP Patient settings BREAS PV 403 PEEP Doc No 003 176 En Issue X 1 BREAS MEDICAL Pag
27. 20 mbar Inspiration time 1 8 seconds Plateau 5 Pressure mbar 20 Pressure setting a Guna oT Patient exhales CL sone PL Peine Start of breath seconds Insp time PCV Pere er rrr errr l l Flow I I l I l l 100 1 lt u Max flow and sel pressure is reached Patient exhales seconds Page 32 BREAS MEDICAL Doc No 003 176 En Issue X 1 Operating Manual PV 403 PEEP Ventilation modes and parameters 8 3 PSV mode Pressure Support Ventilation In the PSV mode the patient normally controls both the inspiration through the inspira tion trigger and the exhalation by the expiratory trigger The ventilator has basic settings which are usually suitable to start with during the set up An inspiration is started when either the patient triggers a breath if the trigger is acti vated or the back up rate setting of the apparatus takes over The ventilator tries to reach and maintain the set pressure until the expiration starts The inspiration stops and an exhalation starts in four cases The inspiration flow has dropped to the value set for expiratory trigger The inspiration is longer than 3 seconds The ventilator bellows reaches its end position The limit for the high pressure alarm is reached The figure below shows how the pressure plateau and expiratory trigger settings control the ventilator s function in the PSV mode The following settings have been used Pressure 20 m
28. En Issue X 1 BREAS MEDICAL Page 27 Supplying oxygen Operating Manual PV 403 PEEP 7 4 Page 28 Follow the instructions below for the pressure limiter The tube connection of the pressure limiter must comply with requirements of the EN 739 standard The pressure limiter should be set to approximately 5 mbar higher than the maxi mum expected patient pressure Instructions for the setting procedure can be found in the operating instructions that accompany the pressure limiter Connecting the oxygen supply To connect the oxygen supply to the patient circuit 1 Connect the pressure limiter to the patient air outlet on the PV 403 PEEP 2 Connect the oxygen adapter for the oxygen connector to the pressure limiter 3 Fitthe T adapter for the oxygen sensor between the exhalation valve and the patient circuit tube Fit the oxygen sensor to the T adapter and connect it to the oxygen monitor Start the PV 403 PEEP and the oxygen monitor Adjust the alarm levels for the oxygen monitor NOAOA Connect as described in the monitor s operating instructions the monitor s oxygen alarm Connect the oxygen source to the patient circuit tube and the oxygen adapter Adjust the oxygen flow at the oxygen source flow meter until the oxygen monitor shows the prescribed value Op analyser Oe ee ee es CTH mm Pressure limiter BREAS MEDICAL Doc No 003 176 En Issue X 1 Operating Manual PV 403 PEEP Supply
29. Issue X 1 Operating Manual PV 403 PEEP Complete function check 11 10 Alarm check high rate To check the alarm for high rate 1 Press the Alarm set button RATE 4 20 4 BPM 2 Select the Rate parameter INSP TIME 0 5 5 Sec 3 Set the alarm level for high rate to 20 BPM 4 Exit the alarm setting function os INSP TIME o5 Le 5 Sec 5 Set the inspiration trigger to 1 0 mbar to INSP TRIG orr 1 0 3 mbar PLATEAU L Eon make the ventilator self trigger see page 39 6 Check that the yellow alarm LED for rate flashes and an audible alarm is given when the ALARM rate has exceeded the set alarm level ALI ee 7 Readjust the alarm level to its original setting gar a RATE BATTERY 11 11 PEEP function check 1 Press the Function button to select any setting EXP TRIG w 50 parameter Check the PEEP setting on the dis VOLUME o O56 Litres play POWER M 5 PEEP 2 Wait for 5 seconds until no parameter is selected Using a reservoir bag check that the PEEP setting is equal to the actual expiratory pressure now shown on the pressure meter 11 12 Power failure check o The alarm check below should be done without an internal and or external bat tery supply connected To check the alarm for power failure 1 Disconnect the power cord while the ventilator is run pao POWER ning ALARM PRESSURE 2 Check that the red alarm LED for power is lit and an oa cg audible alarm is given BATTERY 3 Reconnect the p
30. Issue X 1 Operating Manual PV 403 PEEP Patient instructions BREAS ventilator Doc No 003 176 En Issue X 1 BREAS MEDICAL Page 79 Patient instructions BREAS ventilator PV 403 PEEP Operating Manual PV 403 PEEP Page 80 BREAS MEDICAL Doc No 003 176 En Issue X 1 Operating Manual PV 403 PEEP Patient instructions BREAS ventilator Doc No 003 176 En Issue X 1 BREAS MEDICAL Page 81 Patient instructions BREAS ventilator PV 403 PEEP Operating Manual PV 403 PEEP Page 82 BREAS MEDICAL Doc No 003 176 En Issue X 1 Operating Manual PV 403 PEEP Patient instructions BREAS ventilator Doc No 003 176 En Issue X 1 BREAS MEDICAL Page 83 Patient instructions BREAS ventilator PV 403 PEEP Operating Manual PV 403 PEEP Page 84 BREAS MEDICAL Doc No 003 176 En Issue X 1
31. Operating Manual PV 403 Table of contents Table of contents T Introduction ii isnmnannsssstes ren isa estate see adesina iinei 5 1 1 Intended MIS 558s cere ai ee Oa oa 5 1 2 Contraindicati nS 5 ie ocrecsacnecsunacesuaesaporaesmeisene KETONO EREKE TENERSE a 5 1 3 About this mandats ananas e aE s 6 2 Safety PreCAUTIONS sisisi andaria innara es ssn tunes near nnnennssne 7 2 1 Safety Symbols Een RM nn nes RE ee ete 10 3 Main components and panels sn 11 3 1 Main COMPONCNtS s Reina a a a a i a ae 11 32 Front panels orao nn tn rennes 12 3 3 Settings atl ice eee ue E EE E een T T aeat agen 13 3 4 NC TSG S play enre RE Re ee a A ee ee 16 3 5 Rear pate lente ns ne en S re 17 4 Using the PV 403 P EP iiccansssannnemmanneciaennssstdacunseuaencnten 19 4 1 Installing the PV 403 PEEP nt SR ct ce Ne 19 4 2 Placing the PV 403 PEEP vernie n a Re me ste ts 19 4 3 Connecting the pPalenteireUIt Sn tiendennes 19 4 4 Connecting the PV 403 PEEP to the mains eesseeesseeeeereeeeeees 20 4 5 Switching the PV 403 PEEP on and Off cee eeeceesneceesteeeeeneeeeeees 21 4 6 Displaying the voltage of the current power source seeeeeeeee 21 4 7 Checking the PV 403 PEEP before use 21 4 8 To monitor the exhaled volume 22 5 Using a battery SUPPIY css sien ss sataaasteesreneennss 23 5 1 Power source PHOTOS nn er nr nn en ne 23 5 2 Indicating battery operation p20 lt e scveccssacececesatestecnpeot saa ysteveedesesesteeaetiee 23 5 3 Using an
32. a breathing therapy Part 1 Sleep apnea breathing therapy devices Classification Class IT IEC 60601 1 Specification Class IL Type BF Electrical equipment with dual isolation and body floating isolated applied part according to IEC 60601 1 Class Hb Classification according to the European Medical Device Directive 93 42 EEC IPX1 Degree of protection provided by enclosure a The PV 403 PEEP and it s packaging does not contain any natural rubber latex Issue X 1 BREAS MEDICAL Page 71 Technical specifications Operating Manual PV 403 PEEP 16 4 Delivery settings Parameter Setting Mode PCV Pressure 10 mbar Rate 8 BPM Inspiration time 1 5 Seconds Inspiration trigger 0 5 mbar Plateau 7 Expiration trigger Alarm for low volume 0 05 Litres Alarm for low pressure 5 mbar Alarm for high rate OFF Page 72 BREAS MEDICAL Doc No 003 176 En Issue X 1 Operating Manual PV 403 PEEP 17 Accessories Accessories This chapter presents the BREAS accessories that are currently available for the PV 403 PEEP In the following section you will also find user instructions for the external battery pack Use only BREAS accessories for maximum performance and safety Description Part no Patient circuit PV 403 PEEP PV 401 with exhalation valve 000 402 Flex tube 22 22 mm 8 5 cm length 000 297 Flex tube 22
33. ach function Preparing the function check To prepare the PV 403 PEEP for the function check 1 Connect the ventilator to the mains supply 2 Make sure the patient circuit is correctly connected see page 19 3 Start the ventilator by pressing the On Off button for 2 seconds The green Power and On Off LEDs are lit and the ventilator starts 4 Ifthe lock function LED shows a green light the settings panel has been locked Press and hold both the and buttons for 5 seconds to unlock the settings panel If necessary change the selected mode by using the Mode button 5 Adjust the ventilator settings as follows Doc No 003 176 En Issue X 1 BREAS MEDICAL Page 49 Complete function check Operating Manual PV 403 PEEP 11 2 11 3 Page 50 Pressure 15 mbar Rate 10 BPM PRESSURE 6 15 mbar Insp Time PSV mode TE 4 10 BPM VCV PCV mode 1 8 seconds 1 os Sec Insp Trig aA INSP TRIG orrz0 5 s mbar Plateau PSV PCV mode Setting 6 167 VCV mode EXP TRIG 1 30 s Exp Trig PSV mode 30 SR VCV PCV mode oe s Pac Volume VCV mode 0 5 litres PSV PCV mode Alarm check low pressure To check the low pressure alarm f ALARM 1 Make sure that the red alarm LED for pressure starts to wee aan flash after 15 seconds and that an audible alarm is heard SET VOLUME 2 Block the exhalation valve with your hand to create a aoe pressure 3 Check that the set pressure is indicated on the pressure met
34. alarm and then will be switched off if the internal battery voltage drops below 21 2 V for more than 15 seconds BREAS MEDICAL Page 25 Using a humidifier with the PV 403 PEEP Operating Manual PV 403 PEEP 6 6 1 Page 26 6 2 6 3 Using a humidifier with the PV 403 PEEP This chapter describes how to use the PV 403 PEEP with an optional humidifier If humidification is needed when using the PV 403 PEEP make sure you follow the instructions below as well as the instructions from the manufacturer of the humidifier Humidification devices These instructions relate to the following types of humidification devices Heat and moisture exchanger HME or artificial nose Heated humidifier that complies with the ISO 8185 standard Placing a heated humidifier If a heated humidifier is used always place the humidifier lower than the patient and the PV 403 PEEP This prevents the water from causing personal injury or equipment dam age when running down if the humidifier tips over Connecting the humidifier To connect an HME Connect the device to the patient circuit between the trach connector and the flex tube or follow the manufacturer s instructions The HME increases resistance to airflow especially when saturated with exhaled mois ture The HME may cause the PV 403 PEEP to show a small pressure on the display bars even when not connected to a patient The low pressure alarm must be readjusted to a safe level
35. ask Follow the instructions below when cleaning the ventilator see also page 55 in the operating manual Always be careful when cleaning so as not to damage any equipment Step Procedure Comment 1 e Wipe the outside of the ventilator using a damp cloth witha The fluid must not enter into the little mild washing up liquid or window cleaning fluid ventilator 2 e Remove all tubes before cleaning Make sure that no water enters e Clean the patient hose exhalation valve flex tube and into the tubes mask when required using warm water and a mild deter The thin tube to the exhalation gent valve does not need to be cleaned 3 e Unscrew the cover to the exhalation valve No water must enter into the Let the thin tube remain connected to the exhalation valve membrane or the thin tube e Clean the membrane assembly while still fitted to the cover A e Let all parts dry before reconnecting them see figure Always perform a leakage test when you have cleaned disconnected the patient circuit before connecting it to the patient Doc No 003 176 En Issue X 1 BREAS MEDICAL Page 77 Patient instructions BREAS ventilator PV 403 PEEP Operating Manual PV 403 PEEP Maintenance The ventilator complete with patient circuit power cord and operating manual must be handed in every 12 months or 6 months if used 24 hours a day to authorised personnel for maintenance service Page 78 BREAS MEDICAL Doc No 003 176 En
36. ask when the PV 403 PEEP is to be used by a new patient Use a bacteria filter between the patient outlet and the tube if the PV 403 PEEP is used by different patients at the clinic 12 6 Cleaning the BREAS exhalation valve The exhalation valve should be cleaned according to the clinic s instructions To clean the exhalation valve 1 Unscrew the cover completely together with the membrane assembly A The membrane can be cleaned properly while still fitted to its cover The membrane assembly is replaced as a complete unit 2 Use warm water and a mild detergent to clean the exhalation valve 3 Let the thin tube remain connected to the nipple B to prevent water from entering into the mem brane Take care not to allow water to enter into the thin tube The inside of this tube does not need to be cleaned 4 Always perform a leakage test after cleaning the a exhalation valve before reconnecting the patient circuit see the chapter Patient instructions BREAS ventilator PV 403 PEEP on page 76 12 7 Change of patient If the PV 403 PEEP is taken over by another patient take the following steps 1 Change bacteria filter and air filters fine and coarse dust filters 2 Clean the outside of the PV 403 PEEP and if contamination is suspected carry out a bacteriological investigation 3 If step 2 is positive the air carrying parts should be disinfected in the Aseptor ster iliser 4 If step 2 is negative clea
37. ation 1 Model designation 2 Serial number 3 Read Disposal on page 60 for information about recycling et and disposal a 4 E Class II equipment dual isolation 5 Li Body floating 6 Read the operating manual thoroughly before connecting the N PV 403 PEFP to the patient 7 CE marking applies according to the directive MDD 93 42 AA fan 0123 EEC BREAS MEDICAL Doc No 003 176 En Issue X 1 Operating Manual PV 403 PEEP Main components and panels 3 3 1 Main components and panels This chapter gives an overview of the main components and the panels of the PV 403 PEEP For more information on the settings of the ventilator see the chapter Setting the PV 403 PEEP on page 36 Main components The figure below displays the main components of the PV 403 PEEP Main components The table below describes the main components of the PV 403 PEEP No Component Description 1 Front panel Panel used for connecting PV 403 PEEP to the patient circuit 2 Settings panel Panel with user controls indicator LEDs and LCD display used for adjusting the patient settings 3 Rear panel Panel used for connecting the PV 403 PEEP to the power source and to external equipment 4 Air inlet and filter The filter is used for filtering incoming air cassette For details see page 55 Doc No 003 176 En Issue X 1 BREAS MEDICAL Page 11 Main components and panels 3 2 Page 12 Front panel
38. bar Expiratory trigger 25 and Plateau 5 Pressure mbar Pressure 20 setting seconds Exp Trig 25 Lg 4 Flow has dropped to set Exp Trig setting New breath is triggered seconds Patient exhales l a VU Doc No 003 176 En Issue X 1 BREAS MEDICAL Page 33 Ventilation modes and parameters Operating Manual PV 403 PEEP 8 4 Comparing PCV and PSV modes The figure below shows the previous two examples superimposed to illustrate how the PCV and PSV modes differ Pressure mbar 20 a BOLE TTT seconds q Insp time PSV l TELEECEELEECEE LEE seconds Page 34 BREAS MEDICAL Doc No 003 176 En Issue X 1 Operating Manual PV 403 PEEP Ventilation modes and parameters 8 5 VCV mode Volume Control Ventilation In the VCV mode the ventilation is controlled by the PV 403 PEEP This is done by the volume rate and inspiration time settings An inspiration is started either when the set rate of the ventilator starts a breath or when the patient triggers a breath if the trigger function is activated The ventilator calculates at which speed the volume must be increased to reach the set volume during the set inspiration time The inspiration stops and an exhalation starts in two Cases The set value for volume has been reached e The limit for the high pressure alarm is reached The figure below shows how the volume and inspiration time settings control the
39. ceeeeeeenes 47 11 Complete function Check nssssssnnnnnnneneene 49 11 1 Preparing the function check ss nantes an antenne 49 11 2 Alarm check low pressures rations tmmnonssnsesne ner eu nt 50 113 Inspiration CMCC xs es annee nr 50 PAA XhATONCRECRS SR rn we coals ane 51 11 5 Alarm check high Pressure si cesacoxe conccacariaeteeceoncorineceamneeenton cues 51 11 6 Inspiration trigger check seseeeeseenssesesestesseeesseeesereesseresseessereesseesse 51 11 57 EXxXpitatoty trigger echeck us enr nat naine 52 11 82 Tidal volume CHR nana dirt 52 11 9 Alarm check low tidal volume 52 11 10 Alarm check ie MATOS Re ne te 53 11 11 PEEP f nctiom echeck En nan E AETA 53 1112 Power Pare CHECK cede nueecenacessanicneaussies sad conde nsncy rieien een a 53 11 13 Completing the function CR CI ESS RIR Re ee Re 54 12 Cleaning the PV 403 PEEP and replacing the filters 55 12 1 Cleanine disinfection in the chimie hassan 55 12 2 Cleaning disinfection in the HOME Lens tentant 56 12 3 Cleaning and replacing the patient air filter 56 124 Using a Bacteria Ternes er ARR 57 12 5 Cleaning the mask and tubes san deenvanesossterexoasnsnsetes 57 12 6 Cleaning the BREAS exhalation valve 58 12 7 Change or patient eee en eee eee tae arenas 58 Page 2 BREAS MEDICAL Doc No 003 176 En Issue X 1 Operating Manual PV 403 Table of contents 13 MAINTON ANG Cio cosas cesses dendancntinswawceceasauanssaddaatinan
40. charged The PV 403 PEEP can also be operated from an external or internal battery supply see the chapter Using a battery supply on page 23 0 The ventilator will start the power failure alarm and then will be switched off if the mains voltage drops below 85 V AC and there is no back up battery source installed Switching the PV 403 PEEP on and off To switch on the PV 403 PEEP Press the On Off button on the settings panel for 2 seconds The LED on the On Off button is used as follows Steady green light the PV 403 PEEP is switched on running from the mains sup ply Flashing green light the PV 403 PEEP is switched on running from the external or internal battery supply To switch off the PV 403 PEEP 1 Press the On Off button on the settings panel for 2 seconds The alarm LEDs start flashing and an audible alarm is heard 2 Press the On Off button once again to switch off the ventilator If you do not press the button within 5 seconds the ventilator will return to normal operation Displaying the voltage of the current power source To check the voltage Press the button on the settings panel The voltage of the current power source used by the ventilator is displayed M mains power E external battery I internal battery Checking the PV 403 PEEP before use Before using the PV 403 PEEP perform the following checks Perform a short function check once a day see the chapter
41. chnical specifications on page 65 Do not use the PV 403 PEEP immediately after storage or transport outside the rec ommended operating conditions The device complies with the requirements of IEC 601 1 2 with regards to Elec tromagnetic compatibility Necessary measures must be taken in order to ascertain that the specified limits are not exceeded as this may impair the safety of the venti lator Such measures should include but not be limited to normal precautions with regard to relative humidity and conductive characteris tics of clothing in order to minimise the build up of electrostatic charges avoiding the use of radio emitting devices in close proximity to the equipment such as high frequency surgery apparatus or cordless mobile telephones CB radios microwave ovens etc resulting in a field level exceeding 10 V m avoiding the use of patient hoses or tubes made of static or electrically conduc tive material User precautions Use a new patient circuit for each new user of the PV 403 PEEP Patient connected parts and filter must be replaced regularly to ensure correct func tion of the PV 403 PEEP All replaced parts must be disposed of according to local environmental regulations regarding the disposal of used equipment and parts If the PV 403 PEEP is used in a clinic by several users a bacteria filter must be fit ted between the air outlet and the patient circuit to prevent contamination C
42. configures a medical system and is therefore responsible that the system complies with the requirements of the valid version of the system standard IEC 601 1 1 If in doubt consult the technical service department or your local representative All connected equipment must be placed at least 1 5 metres away from the patient n When the PV 403 PEEP is being used by a patient it must not be connected to a PC Analog connection The analog connection is used for registering the patient pressure and the estimated tidal volume during operation at night It is normally connected to an analog printer or sleep registering equipment Pins Input Output Pins 1 7 21 23 24 25 Ground Pin 4 Reference Pin 9 Analog 1 0 5 V input Pin 10 Analog 1 Ground Pin 11 Analog 2 0 5 V input Pin 12 Analog 2 Ground Pin 16 Pressure 0 mbar 1 V 10 mbar 2 V etc output Pin 17 Volume 0 5 litre 0 5 V 1 litre 1 V etc output Page 68 BREAS MEDICAL Doc No 003 176 En Issue X 1 Operating Manual PV 403 PEEP Technical specifications 16 2 Digital connection The digital connection may be used for connecting the PV 403 PEEP to a PC for patient data analysis Pins Input Output Pin 2 TX Pin 3 RX Pin 7 Ground Pin 18 12 V DC Pin 19 12 V DC Alarm output connector The alarm output connector in the rear panel is used for connecting the PV 403 PEEP to an external alarm de
43. ct the ventilation mode 1 To select the PCV PSV or VCV mode press the Mode PSV MODE button for 1 second The LED of the next mode in sequence starts to flash VCV 2 Press the Mode button once more to activate this mode The LED shows a steady light 3 If necessary repeat the steps above until you have selected and activated the right mode Setting the pressure The pressure parameter is used for setting the patient s airway pressure during the inspi ration phase The pressure is measured at the exhalation valve on the patient circuit This setting is done in the PCV and PSV mode The green Pressure LED on the left hand side of PRESSURE settings panel indicates an inspiration The actual patient pressure is displayed in the pressure meter on the settings panel mbar cmH20 Ce 0 10 20 30 40 Setting range 6 to 50 mbar If the control electronics fail the PV 403 PEEP cannot deliver a pressure higher than 60 mbar at a single fault condition To set the inspiratory pressure 1 Press the Function button until the Pressure PRESSURE 6 15 so mbar LED is lit RATE 10 BPM 2 Press the buttons to decrease increase INSP TIME os 1 85 Sec the setting Setting the rate The rate setting corresponds to the patient s breathing rate expressed as the number of breaths per minute BPM The ventilator gives the set number of breaths plus any triggered breaths The display always shows the set or triggered valu
44. d LEDs e Power power failure during operation steady light e Pressure the delivered pressure is higher or lower than the set alarm levels e Volume the tidal volume is below the set alarm level Medium priority alarms yellow LEDs e Rate the breath rate has exceeded the set alarm level e Battery the internal battery voltage drops below 23 3 V during operation Page 14 BREAS MEDICAL Doc No 003 176 En Issue X 1 Operating Manual PV 403 PEEP Main components and panels No User controls Function indicator LEDs 10 On Off button Used for switching the PV 403 PEEP on or off LED indicating that the ventilator is switched on and connected to power source e Steady light running from mains supply e Flashing light running from battery supply Doc No 003 176 En Issue X 1 BREAS MEDICAL Page 15 Main components and panels Operating Manual PV 403 PEEP 3 4 LCD display The table below describes the user controls and the corresponding indicator LEDs on the LCD display of the PV 403 PEEP No User controls Function and indicator LEDs A Pressure User control used for reading and setting the patient pressure Left LED indicating inspiration B Rate User control used for setting and displaying the patient s breathing rate C Insp Time User control used for setting and displaying the inspiration time D Insp Trig Used for setting and displaying the
45. d stop and an exhalation phase should start This setting can only be selected in the PSV mode Setting range 10 to 50 of the maximum flow BREAS MEDICAL Doc No 003 176 En Issue X 1 Operating Manual PV 403 PEEP Setting the PV 403 PEEP 9 11 9 12 10 gives a relatively longer inspiration time and larger volume 50 gives a relatively shorter inspiration time and smaller volume A normal setting is 25 to 30 To set the expiratory trigger PLATEAU L JoL 1 Press the Function button until the Exp Trig EXP TRIG 1 39 0 LEDs it a VOLUME o 0 7516 Litres The current expiratory trigger setting 1s dis played POWER M PEEP 2 Press the buttons to decrease increase the setting if required Setting the tidal volume The tidal volume setting controls the volume delivered by the ventilator at each breath You can only adjust this setting in the VCV mode However the measured tidal volume delivered by the ventilator is shown on the display in the PSV and PCV modes If the patient uses an oxygen supply with the ventilator you must adjust the setting to balance the additional apparatus see page 29 Setting range 0 3 litre to 1 6 litre To set the tidal volume EXP TRIG 1 50 1 Press the Function button until the Volume LED VOLUME o 44 16 Litres is lit POWER M PEEP 2 Press the buttons to adjust the tidal volume setting Incorrect settings for rate and tidal volume If the settings combination for
46. e 56 BREAS MEDICAL Doc No 003 176 En Issue X 1 Operating Manual PV 403 PEEP Cleaning the PV 403 PEEP and replacing the filters Mn My My 1 Mun mM To wash the air filter 1 2 A Pull out the filter cassette and take the air filter out of its holder Wash the filter using warm water and if necessary a mild detergent Rinse thor oughly Dry the filter by squeezing it out in a towel Do not wring the filter Fit the filter to its holder when the filter is dry Switch on the ventilator and make sure it operates normally 12 4 Using a bacteria filter Use a bacteria filter between the patient and the PV 403 PEEP This is intended to pro tect the patient from contamination from the unit and the unit from bacteria and viruses from the patient In the case of non invasive ventilation the bacteria virus filter must be replaced at least once a week With invasive ventilation after 48 hours at most 0 Observe the bacteria filter life stated by the manufacturer 12 5 Cleaning the mask and tubes Follow the instructions below when cleaning the mask and tubes Clean the mask each day according to the instructions from the responsible clinic or manufacturer Hang up the cleaned mask and tubes so that they dry before they are used again Doc No 003 176 En Issue X 1 BREAS MEDICAL Page 57 Cleaning the PV 403 PEEP and replacing the filters Operating Manual PV 403 PEEP Always clean the mask and tubes or use a new m
47. e 75 Patient instructions BREAS ventilator PV 403 PEEP Operating Manual PV 403 PEEP Patient instructions BREAS ventilator PV 403 PEEP These instructions must be thoroughly explained to the patient together with the doctor before the patient or care giver takes over the operation at home D Daily function check The settings of the ventilator may be adjusted by clinic personnel only The ventilator casing may be opened by authorised personnel only Before using the ventilator always perform the following function check Step Function check Comment 1 e Start the ventilator by pressing the On Off Mains power Green On Off LED M in button power field on LCD display e Check the power source Battery supply Flashing green On Off LED E external or T internal in power field on LCD display 2 e Connect the complete patient circuit The alarm LED for pressure is lit and an including HME if used and tracheostomy audible alarm is given after 15 seconds extension flex tube or mask Make sure it is not blocked The low pressure alarm should be reset once e Check that the low pressure alarm is acti the pressure reaches the alarm level vated If not adjust the low pressure alarm setting e Block the patient circuit and check that the alarm is reset e Check the high pressure alarm See page 44 in the operating manual e Block the patient circuit The alarm LED for volume is lit and
48. e regulated breathing In the PSV mode Pressure Support Ventilation the ventilator s expiratory sense can also be adjusted allowing the ventilator to more easily match each patient s needs In the VCV mode Volume Controlled Ventilation the ventilator provides assisted or controlled volume regulated breathing The internal PEEP Positive End Expiratory Pressure function is used for controlling the patient s airway pressure during the exhalation phase The internal patient data memory of the PV 403 PEEP can be downloaded to a PC printed out and analysed via the Patient Data Analysis software package For more information about this software package please contact your BREAS representative Intended use The PV 403 PEEP is intended for treatment in institutions and patients homes e by qualified trained personnel under the direction of a physician of adult and pediatric patients with reduced lung function using either a nasal mask or a trach tube that may be life supporting provided that an internal or external battery back up source is used and emergency equipment resuscitation bag is available Contraindications The contraindications for treatment by the PV 403 PEEP could be as follows Generally after thoracic surgery the surgeon has to be consulted to avoid organ damage After heart surgery care should be taken to choose ventilator parameters which do not adversely affect haemodynamics
49. e setting up and using the PV 403 PEEP 4 1 Installing the PV 403 PEEP When using the PV 403 PEEP for the first time check the device for damage and to be sure that all ordered accessories are included according to the packing note or the invoice 4 2 Placing the PV 403 PEEP Follow the instructions below for the placement of the PV 403 PEEP Do not use the PV 403 PEEP when exposed to direct sunlight Place the PV 403 PEEP on a solid flat surface Make sure that nothing can block the filter cassette air inlet at the rear right hand side of the ventilator Check that the PV 403 PEEP cannot be affected by any electromagnetic fields emit ted by other nearby equipment 4 3 Connecting the patient circuit To connect the PV 403 PEEP to the patient circuit 1 D Connect the patient circuit to the patient air outlet on the front panel see figure below If a bacteria filter oxygen adapter 1s used connect it between the hose and the patient air outlet Connect the other end of the patient tube to the exhalation valve Connect the thin white control tube to the exhalation valve connector indicated by a white symbol on the front panel Connect the other end to the membrane nipple Connect the green pressure sensor tube to the pressure measuring connector indi cated by a green symbol on the front panel Connect the other end to the pressure sensor nipple of the exhalation valve Connect the exhalation valve to the flex tube Con
50. e the ventilator is currently working at Setting range 4 to 40 BPM Doc No 003 176 En Issue X 1 BREAS MEDICAL Page 37 Setting the PV 403 PEEP Operating Manual PV 403 PEEP 9 5 9 6 Page 38 To set the rate 1 Press the Function button until the Rate LED is PRESSURE 6 15 so _ mbar lit RATE 4 10 42 BPM The current rate setting is displayed INSP TIME os 1 8 5 Sec 2 Press the buttons to decrease increase the INSP TRIG orr 20 5 8 setting if necessary mbar Setting the inspiration time Insp Time The inspiration time setting controls the length of each inspiration This setting can be selected in the PCV and VCV modes An accurate setting of the inspiration time is required for maximum patient comfort and the most effective result Setting range 0 5 to 5 seconds To set the inspiration time PRESSURE 6 15 50 mbar 1 Press the Function button until the Insp Time LED is lit RATE 4 10 BPM The current inspiration time setting is displayed INSP TIME os 1 8 5 Sec 2 Press the buttons to decrease increase the INSP TRIG orr 2_0 5 s mbar setting if required ee _ VE Ratio table The table below displays the values used for calculating the I E ratio based on the inspi ration time and rate In the example below see the markings in the table the inspiration time is set to 1 5 sec onds and rate to 12 BPM This gives an VE ratio of 1 2 BREAS MEDICAL Doc No 003 176 En Issue X 1
51. er PRESSURE The alarm should stop once the pressure exceeds Sa ag PEER es the set alarm level mbar cmH20 a The low tidal volume alarm may be alerted when you are blocking the exhalation valve Inspiration check To check the inspiration 1 Connect a 0 5 litre reservoir bag to the patient circuit 2 Check that the membrane in the exhalation valve seals properly 3 Check that the reservoir bag inflates The pressure meter should show a pressure of approximately 15 mbar before the inspira tion stops Depending on the compliance of the reservoir bag the breaths can be stopped more quickly for different reservoir bags BREAS MEDICAL Doc No 003 176 En Issue X 1 Operating Manual PV 403 PEEP Complete function check 11 4 Exhalation check 11 5 11 6 To check the exhalation Check that the air flows easily from the reservoir bag out through the exhalation valve Alarm check high pressure To check the high pressure alarm PSV PCV mode The alarm is only activated under exceptional conditions in PSV and PCV modes such as a strong cough during the ventilator s inspiration phase or an internal error of the PV 403 PEEP Normally the ventilator adjusts the pressure to the set level 1 During the inspiration phase press the reser EEND voir bag to alert the high pressure alarm by POWER nitat ALARM imitating for example a cough zi os 2 Atthe same time control the pressure meter to RATE see at what pre
52. ervice Setting the alarm levels in PSV and PCV modes In the PSV and PCV modes you should set the alarm levels for low pressure high rate and low tidal volume If you have started the alarm setting procedure and do not press any button within 10 seconds the display will return to the standard setting display Press the Func tion button once to return to the alarm setting function To start the alarm setting 1 Press the Alarm set button on the settings panel PRESSURE ALARM so mbar The display will change as shown in the figure RATE a SET BPM 2 Select Yes by pressing the button INSP TIME os Sec The display shows the current alarm settings see INSPTRIG orra te figure below PLATEAU 3 L TL EXP TRIG a 5 voume b L s bites POWER i PEEP To set the alarm level for high rate 3 Press the Function button until the Rate LED is PRESSURE 6 z mbar lit RATE 4 40 40 BPM 4 Adjust the setting using the and or button INSP TIME o s 5 Sec If you want to turn off the alarm press the but INSP TRIG orMIN 158 mbar ton repeatedly until Off is displayed Setting range 10 to 60 BPM Off PLATEAU L TL EXP TRIG 10 50 To set the alarm level for low pressure VOLUME o 449 16 Litres 5 Press the Function button until the Insp Trig POWER QUITE PEEP LED is lit 6 Adjust the setting using the and or button Setting range 3 to 40 mbar BREAS MEDICAL Doc No 003 176 En Issue X 1 Operating
53. ing oxygen 7 5 Adjusting the tidal volume and the oxygen flow VCV mode When oxygen is supplied to the ventilator in VCV mode the tidal volume setting and oxygen flow should be reduced to balance the additional volume of the oxygen appara tus To adjust the tidal volume 1 Use the following formula for calculating the adjusted tidal volume V Vr FI1O 0 79 where V Adjusted tidal volume setting for the PV 403 PEEP in litres Vr Prescribed tidal volume for the patient in litres FIO The oxygen s fractional concentration for the patient in 100 for example 45 0 45 2 Set the tidal volume of the ventilator see page 41 To adjust the oxygen flow 1 Use the following formula for calculating the adjusted oxygen flow Oz flow Vr_ V xfr where O gt flow Oxygen flow litres min Vr Prescribed tidal volume for the patient in litres V Adjusted tidal volume setting for the PV 403 PEEP in litres fr The patient s breath rate BPM 2 Set the oxygen flow at the oxygen supply equipment Doc No 003 176 En Issue X 1 BREAS MEDICAL Page 29 Ventilation modes and parameters Operating Manual PV 403 PEEP 8 8 1 Page 30 Ventilation modes and parameters This chapter includes descriptions of the modes and parameters used for controlling the ventilation of the PV 403 PEEP Clinic personnel should read this reference chapter to fully understand the function of the PV 403 PEEP before setting up
54. inspiration trigger setting Left LED indicating that the patient triggers a breath E Plateau Used for setting and displaying the speed at which the pres sure or volume increases to the desired value F Exp Trig Used for setting and displaying the expiratory trigger G Volume User control used for setting and displaying the delivered tidal volume H Power User control used for displaying e the current power source M mains power E external battery or I internal battery e the voltage of the current power source Left LED indicating that the PV 403 PEEP is connected to the mains I PEEP Used for setting and displaying the internal PEEP function J Indicator LEDs LEDs on the right hand side of the display that indicate which of the functions listed above is selected when pressing the Function button Pressure mbar Rate BPM Inspiration time Sec Inspiration trigger mbar Plateau Expiratory trigger Tidal volume Litre PEEP mbar Page 16 BREAS MEDICAL Doc No 003 176 En Issue X 1 Operating Manual PV 403 PEEP 3 5 Rear panel The components and the user controls on the rear panel of the PV 403 PEEP are shown in the illustration below 1 Main components and panels 2 3 4 5 6 User controls and components The table below describes the functions of the user controls the connectors and other components on the rear panel No User controls and c
55. is alarm is optional you may keep it turned off during operation When the alarm for high rate is alerted the following happens The yellow alarm LED for high rate flashes The medium priority alarm signal is given The alarm is reset once the rate drops below the alarm level Low battery alarm The low battery alarm is alerted when the PV 403 PEEP is run from the internal battery source and the voltage drops below 23 3V The low battery alarm is indicated as follows The yellow alarm LED for battery failure flashes The meduim priority alarm signal is given The alarm will be reset once the battery voltage reaches or exceeds the alarm level If operated from an external battery the PV 403 PEEP will switch over to the internal battery source in case the voltage drops below 21 2 V 10 6 V The ventilator will continue to run for approximately 10 minutes and then it will be switched off Doc No 003 176 En Issue X 1 BREAS MEDICAL Page 45 Alarm 10 8 10 9 Page 46 Operating Manual PV 403 PEEP Function error alarm If an internal fault occurs the following happens A continous audible alarm is given On the LCD display a fault code is shown for example GAUGE MATCH FAIL CHECK TUBE see the chapter Troubleshooting on page 61 or the BREAS Ser vice Manual Follow the instructions below Switch off the machine If the fault persists do not use the machine and send it for s
56. l of used equipment and parts Cleaning disinfection in the clinic PV 403 PEEP Follow the instructions below when cleaning the casing of the PV 403 PEEP Do not sterilise the machine using an autoclave Clean the outside of the machine using a lint free cloth and a mild detergent such as washing up liquid or surface disinfectant Fluid or moisture must not be allowed to enter into the PV 403 PEEP Disinfection agents Preparations in which the active agent is one of the following will not harm the material Aldehydes Alcohols Agents based on the following may damage the materials Compounds that release halogens Strong organic acids Compounds that release oxygen 0 Follow the manufacturer s instructions for use Ventilator accessories The following accessories can be sterilised in steam sterilisers at up to 126 C e Patient circuit tube Hytrel Silicone exhalation valve line Silicone PAP pressure line Exhalation valve dismantled e AMBU PEEP valve Pressure limiter Doc No 003 176 En Issue X 1 BREAS MEDICAL Page 55 Cleaning the PV 403 PEEP and replacing the filters Operating Manual PV 403 PEEP 12 2 Cleaning disinfection in the home PV 403 PEEP Follow the instructions below when cleaning the casing of the PV 403 PEEP Clean the outside of the machine using a lint free cloth and a mild detergent such as washing up liquid Fluid or moisture must not be al
57. lowed to enter into the PV 403 PEEP Ventilator accessories All parts that come into contact with the respiration gas must be cleaned as follows 1 Place the dismantled parts in hot water containing washing up liquid 2 Remove fouling with a brush 3 Rinse parts thoroughly under running hot water 4 Shake water out of all parts especially the control and metering hose and the bal loon of the exhalation valve 5 Dry the parts completely 6 Store in dust free location If the parts need to be disinfected this can be done in a bath of Virkon or Lysetol Med for instance Then rinse the parts well in clear water and dry them thoroughly o Follow the manufacturer s instructions for use n Any water left behind in the control hose or the exhalations valve may lead to malfunctions 12 3 Cleaning and replacing the patient air filter The patient air filter is located in the filter air inlet cassette at the rear of the ventilator see figure below There are two types of filters washable filters and disposable filters Filter Usage Washable filter grey colour Mandatory filter Wash the filter at least once a week Replace the washable filter at least once a year Disposable filter white colour Mandatory filter Replace the filter at least every month after 500 opera tion hours or more often when used in high pollution or pollen rich environments o Do not wash and reuse the disposable filter Pag
58. m Possible cause Remedial action Fault code FAIL 66 or e The green pressure tube in Connect the patient circuit correctly GAUGE MATCH FAIL the patient circuit is incor CHECK TUBE is rectly connected shown on the display e Humidity in green pres e Dry the green pressure tube sure tube e If the fault persists contact service personnel Fault code LOW e The power voltage e Check the power source VOLTAGE is shown on mains or battery is too the display low Fault code FAIL XX is The ventilator does not e Send the ventilator for service shown on the display function where XX is a number Page 62 BREAS MEDICAL Doc No 003 176 En Issue X 1 Operating Manual PV 403 PEEP Service 15 15 1 Service Service of the PV 403 PEEP must be carried out by authorised personnel only Authorised service workshops may order the BREAS Service Manual that con tains all technical documentation such as instructions calibration data circuit diagrams component lists and so on required for the maintenance and service of the PV 403 PEEP Yearly maintenance check The PV 403 PEEP should be tested and inspected by the responsible clinic with the fol lowing frequency Once a year if the ventilator is used only at night 10 12 hours a day Twice a year if the ventilator is used day and night This maintenance service must be carried out according to the maintenance scheme in the BREAS Service Manual and a
59. me PLATEAU _ LM O5IL 1 Press the Function button until the correspond ing LED for the required setting 1s lit EXP TRIG 0 50 VOLUME o SET 16 Litres 2 Press the buttons to increase or decrease the DATE PEEP tti I POWER setting value TIME 3 Continue by stepping down through the settings to the last setting M minutes 4 Switch off the ventilator The new date and or time setting is saved Doc No 003 176 En Issue X 1 BREAS MEDICAL Page 59 Maintenance Operating Manual PV 403 PEEP 13 3 Disposal The PV 403 PEEP any accessories and all replaced parts must be disposed of and recy cled in accordance with the local environmental regulations regarding the disposal of used equipment and waste Batteries used with the PV 403 PEEP shall be recycled in accordance with the local il environmental regulations Page 60 BREAS MEDICAL Doc No 003 176 En Issue X 1 Operating Manual PV 403 PEEP 14 Troubleshooting Troubleshooting If the PV 403 PEEP does not work properly try to identify the problem in the table below Check the possible causes and carry out the suggested remedial actions The alarm functions of the PV 403 PEEP are described in detail in the chapter Alarm on page 43 The fault codes below are only examples BREAS Service Manual includes a complete list of all fault codes used for the PV 403 PEEP Problem Possible cause Remedial action The power indicator LED is li
60. n PRESSURE 5 20 so _ mbar 1 Press the Function button until the Rate or ee 20 Insp Time LED is lit INSP TIME os 3 3 s Sec 2 Press the or buttons to adjust the settings SE occ 0 5 for rate or inspiration time PLATEAU L Eon EXP TRIG 1 50 VOLUME o 0 75 16 Litres POWER M PEEP 9 8 Setting the inspiration trigger Insp Trig Doc No 003 176 En The inspiration trigger setting is used for defining the pressure when the patient initiates a breath assisted by the ventilator If the patient cannot trigger a breath the ventilator will automatically take over and deliver breaths according to the set rate For each breath the patient triggers the green Insp Trig LED on the left hand side of settings panel is lit Setting range Off 2 to 8 mbar Follow the instructions below when setting the pressure of the inspiration trigger Choose a setting comfortable for the patient normally between 0 2 and 0 5 mbar Issue X 1 BREAS MEDICAL Page 39 Setting the PV 403 PEEP 9 9 9 10 Page 40 Operating Manual PV 403 PEEP If a PEEP valve or the PV 403 PEEP s internal PEEP function is used the trigger setting can be set to a positive value that depends on the pressure resistance of the PEEP Example The PEEP gives a pressure resistance of 4 mbar Therefore to maintain the value of the 0 5 mbar required to trigger a breath the trigger setting is set at 3 5 mbar If
61. n as described in this chapter 5 Install a clean patient circuit etc Page 58 BREAS MEDICAL Doc No 003 176 En Issue X 1 Operating Manual PV 403 PEEP Maintenance 13 Maintenance 13 1 Checking the operation hours and software version To check the operation hours and software version Switch on the PV 403 PEEP The display on the settings panel will show the fol lowing settings for approximately 1 second before the PRESSURE 6 493 50 __ mbar ventilator starts working RATE 4 MDH v BPM Model designation INSP TIME os SBC 5 Sec e Installed master software version INSP TRIG orr 2 a mbar e Installed slave software version ie de itai b ooh EXP TRIG 10 50 otal number of operation hours F VOLUME o 91238 Litres The display only shows whole operation hours HOURS POWER PEEP 13 2 Setting the date and time As part of the data analysis function of the PV 403 PEEP the date and time are recorded The recording allows detailed time analysis of the patient data in the different printouts that are available for the ventilator a The clock function uses the 24 hour clock standard To check the date and time Switch on the ventilator by pressing the On Off PRESSURE YOO 50 mbar button for 2 seconds At the same time press and RATE M02 BPM hold down the Function button until the display shows the current date and time see figure 4 INSP TIME os D25 Sec INSP TRIG orr H 11 8 mbar To set the date and ti
62. nect the other end of the flex tube to the mask or the trachea cannula Always follow the mask manufacturer s instructions when applying a nasal mask Doc No 003 176 En Issue X 1 BREAS MEDICAL Page 19 Using the PV 403 PEEP Operating Manual PV 403 PEEP 4 4 Page 20 To adjust the mask and patient circuit 1 Adjust the mask straps so that it feels comfortable for the patient 2 Route the patient circuit in a way convenient for the patient Try different ways to find the best one Do not strap the patient mask too tight Start with loose straps and tighten as neces ij sary to prevent leakage from the mask Connecting the PV 403 PEEP to the mains To connect the PV 403 PEEP 1 Plug the power cord into the power socket of the PV 403 PEEP 2 Connect the cord to the mains supply 3 Secure the power cord in the cable strain relief clamp on the rear panel to prevent that the power cord is accidentally disconnected The Power LED on the settings panel is lit when the PV 403 PEEP is connected to the mains o Make sure that the power cord is undamaged before it is connected to the machine n To isolate the PV 403 PEEP from the mains supply remove the power cord BREAS MEDICAL Doc No 003 176 En Issue X 1 Operating Manual PV 403 PEEP Using the PV 403 PEEP 4 5 4 6 4 7 o The ventilator should be connected to the mains supply even when not in use in order to keep the alarm batteries and the internal batteries
63. nvadeniaubananaseenedvus 59 13 1 Checking the operation hours and software version 59 132 petling the date and tM coccissszscsasucsugeroncescotesaonmsonteateseessewtsesecotevageas 59 13 3 DISPOSONS 60 14 Troubleshooting Sec ne a unten 61 19 Oe Or erra So Sir 63 15 1 Yearly maintenance CH CK Rene de a er et 63 15 2 Service record Sise TA SAR St en 64 16 Technical specifications sn 65 16 1 Analog Digital output connector ss 68 16 2 Alarm output connector sc ia RSR SE Re eee 69 16 3 Compliance of Standards sente nm uns 71 16 4 Delivery SELLES ss Sonnerie esse 72 17 ACCRSSONES nn en nn tt use 73 18 Patient settings BREAS PV 403 PEEP 74 19 Patient instructions BREAS ventilator PV 403 PEEP 76 Doc No 003 176 En Issue X 1 BREAS MEDICAL Page 3 Table of contents Operating Manual PV 403 Page 4 BREAS MEDICAL Doc No 003 176 En Issue X 1 Operating Manual PV 403 PEEP Introduction 1 1 1 2 Introduction The PV 403 PEEP is a pressure controlled pressure support and volume controlled ventilator for patients who require continuous or intermittent support by mechanical ven tilation It has three modes of operation PSV PCV and VCV All modes have an adjustable trig ger sensitivity setting which allows the patient to initiate ventilator assisted breaths In the PCV mode Pressure Controlled Ventilation the ventilator provides assisted or controlled pressur
64. ny amendments issued The inspection should include checking that all the functions of the unit and accessories are operating correctly check ing for damage and materials ageing verifying that the correct pressure is delivered checking and or replacing the battery supply etc Doc No 003 176 En Issue X 1 BREAS MEDICAL Page 63 Service Operating Manual PV 403 PEEP 15 2 Service records The form below should be used when recording the results of the yearly maintenance check 1st yearly service Work Order No Remarks Date performed Name of Servicing Technician Workshop Signature d vez a a Work Order No Remarks Date performed Name of Servicing Technician Workshop Signature d vez a a Work Order No Remarks Date performed Name of Servicing Technician Workshop Signature Work Order No Remarks Date performed Name of Servicing Technician Workshop Signature or raer NO Remarks Date performed Name of Servicing Technician Workshop Signature Work Order No Remarks Date performed Name of Servicing Technician Workshop Signature Work Order No Remarks Date performed Name of Servicing Technician Workshop Signature Work Order No Remarks Date performed Name of Servicing Technician Workshop Signature Work Order No Remarks 10th yearly service Work Order
65. omponents Function 1 Mains power socket Used for connecting the PV 403 PEEP to the mains through the power cord 2 Alarm output Used for connecting the PV 403 PEFP to an external alarm connector device Read the operating manual thoroughly before using the alarm connector see page 69 3 Fastening clamp Used for securing the power cord 4 Alarm buzzer Used for the audible alarm of the PV 403 PEEP 5 Adjust screw for Used for adjusting the sound level of the audible alarm sound level 6 Connector for external battery supply Used for connecting the PV 403 PEEP with BREAS external battery EB 2 or another 24 V DC power source Read the operating manual thoroughly before using the battery connector see page 23 Doc No 003 176 En Issue X 1 BREAS MEDICAL Page 17 Main components and panels Operating Manual PV 403 PEEP No User controls Function and components 7 Analog Digital Used for connecting the PV 403 PEEP to a remote alarm a output connector PC or other external equipment Read the operating manual thoroughly before using the analog digital connector see page 68 Page 18 BREAS MEDICAL Doc No 003 176 En Issue X 1 Operating Manual PV 403 PEEP Using the PV 403 PEEP 4 Using the PV 403 PEEP This chapter describes the basic procedure for operating the PV 403 PEEP It is mainly intended for clinic personnel Read the chapter Safety precautions on page 7 befor
66. ontact your responsible clinic if any of the following symptoms appear dryness of air passages or nose skin sensitivity runny nose ear pain sinus discomfort mood change disorientation irritability or memory lapse Use of humidifier Page 8 If a heated humidifier is used together with the PV 403 PEEP it must comply with the ISO 8185 standard If a heated humidifier is used always place the humidifier lower than the patient and the PV 403 PEEP This prevents the water from causing personal injury or equipment damage when running down if the humidifier tips over The use of an HME or a heated humidifier may require readjustment of the PV 403 PEEP s low pressure alarm When using a heated humidifier condensation may form in the patient circuit over time Periodically check for moisture in the patient circuit When present remove the moisture Before attempting to dry the circuit disconnect it from the ventilator The frequency at which these checks must be performed will depend on the BREAS MEDICAL Doc No 003 176 En Issue X 1 Operating Manual PV 403 PEEP Safety precautions patient s own condition and the device used You should assess this on an individ ual basis in accordance with the patient s needs If the condensation in the patient circuit is excessive the use of a heated humidi fier may require the installation of a water trap in the circuit The water trap pre vents any condensated water in the
67. ower supply The ventilator will start automatically o The check below should be done if an internal and or external battery supply is connected to the ventilator To check the battery supply in case of mains power failure 1 Disconnect the power cord while the ventilator is running from the mains power 2 Make sure the ventilator switches to the external internal battery source connected Doc No 003 176 En Issue X 1 BREAS MEDICAL Page 53 Complete function check Operating Manual PV 403 PEEP 11 13 Completing the function check To complete the function check 1 Press the On Off button on the settings panel for 2 seconds The alarm LEDs start flashing and an audible alarm is heard 2 Press the On Off button once again to switch off the ventilator The function check is now completed o After the function test always adjust the settings to the values prescribed for the patient by the doctor Page 54 BREAS MEDICAL Doc No 003 176 En Issue X 1 Operating Manual PV 403 PEEP Cleaning the PV 403 PEEP and replacing the filters 12 12 1 Cleaning the PV 403 PEEP and replacing the fil ters This chapter describes how to clean the different parts of the PV 403 PEEP and how to replace the patient air filters The patient connected parts and the filters must be replaced regularly to ensure correct function of the PV 403 PEEP All replaced parts must be disposed of according to local environmental regulations regarding the disposa
68. patient circuit from running into the patient airways and causing personal injury Use of oxygen D Oxygen must only be supplied through the patient hose using the BREAS oxygen adapter In some cases an external pressure limiter may be required when adding supple mental oxygen to the patient circuit The following precautions must be taken when using oxygen as its presence can speed up the combustion of flammable materials Naked lights and other sources of ignition must be kept well away from the oxygen cylinder at least two metres Do not smoke in a room where oxygen is being used The room must be well ventilated Do not use aerosols or solvents close to the oxygen supply even when switched off Doc No 003 176 En Issue X 1 BREAS MEDICAL Page 9 Safety precautions 2 1 Page 10 Safety symbols Operating Manual PV 403 PEEP The safety symbols are printed on the equipment designation label of the PV 403 PEEP The equipment designation label and the model serial number label are located under neath the machine They are displayed in the figure below PV 403 PEEP Serial no V510001 01 0073218214351 9 21 V510001 100 240V 50 60 Hz 0 8A 2155 12 24 VDC Max 4A AG al CE BREAS Med cal ab Fofetagsvagen 1 M lnlycke Sweden 3 4 5 6 7 This table describes the symbols on the model serial number label and the equipment designation label No Symbol Explan
69. s by pressing the button INSP TIME os Sec The display shows the current alarm settings see INSP TRIG orr 2 ma figure below PLATEAU L TL EXP TRIG a S voume b Litres POWER i PEEP Doc No 003 176 En Issue X 1 BREAS MEDICAL Page 47 Alarm Operating Manual PV 403 PEEP To set the alarm level for high pressure 3 Press the Function button until the Pressure LED PRESSURE MAX 5050 mbar is lit RATE 4 40 4 BPM 4 Adjust the setting using the and or button INSP TIME os 5 Sec Setting range 10 to 50 mbar INSP TRIG orrMIN 15s mbar To set the alarm level for high rate PLATEAU L JL 5 Press the Function button until the Rate LED is EXP TRIG 10 lit VOLUME 0 1 6 Litres 6 Adjust the setting using the and or button POWER QUIT PEEP If you want to turn off the alarm press the but ton repeatedly until Off is displayed Setting range 10 to 60 BPM Off To set the alarm level for low pressure 7 Press the Function button until the Insp Trig LED is lit 8 Adjust the setting using the and or button Setting range 3 to 40 mbar o The low pressure alarm must be set for the exact configuration of the patient circuit components If you add remove or change components readjust the low pressure alarm 0 The low pressure alarm level is recommended to be set at a level below the average peak airway pressure that will effectively warn the user of any discon nection or loss
70. s alerted the following happens The red alarm LED for pressure flashes The high priority alarm signal is given On the LCD display a flashing down arrow is shown in the pressure field The alarm is reset once the pressure reaches its set value again 0 Some patients will be in danger if they become disconnected from the ventila tor The purpose of the low pressure alarm is to detect such a disconnection but the ventilator can only do so if the alarm is adjusted properly o Some patient circuit components will defeat a low pressure alarm by keeping the pressure in the circuit above the alarm limit Examples of such components include artificial noses HMEs and tracheostomy extension flex tubes 0 If the tubing set is accidentally disconnected from the patient and the set alarm level for low pressure is misleadingly reached owing to an occlusion caused by a nearby object the low pressure alarm will not be activated 10 4 Alarm for high pressure In the PSV and PCV modes the alarm for high pressure is activated if the actual patient pressure is the interval between min 20 mbar and max 55 mbar and e exceeds the set patient pressure by 50 il The alarm is only activated under exceptional conditions in PSV and PCV modes such as a strong cough during the ventilator s inspiration phase or an internal error of the PV 403 PEEP Normally the ventilator adjusts the pressure to the set level In the VCV mode the alarm
71. s power supply fails during operation The ventilator will use the internal battery supply if no external battery is con nected or its voltage is too low The ventilator will automatically return to the mains power once it is restored Indicating battery operation The battery operation is indicated as follows The LED of the On Off button on the settings panel shows a flashing green light In the Power field on the LCD display the letter E external battery or I internal battery is displayed A short audible alarm is given in case the PV 403 PEEP switches to the internal battery Using an external battery The PV 403 PEEP can be operated from a 24 V or a 12 V DC external battery Following the instructions below when connecting an external battery Use BREAS battery cable or the BREAS external EB 2 Battery Pack If using other DC power than BREAS external EB 2 Battery Pack check carefully that the volt age is 12 or 24 V Always check the polarity of the external battery before connecting it to the PV 403 PEEP To connect the external battery 1 2 Connect the battery cable to the external battery connector in the rear panel of the PV 403 PEEP Connect the other end of the cable to the battery source or for example the ciga rette lighter socket in a vehicle Doc No 003 176 En Issue X 1 BREAS MEDICAL Page 23 Using a battery supply Operating Manual PV 403 PEEP 5 4 Page 24 Low battery voltage
72. ssure the high pressure alarm us starts 3 Make sure the pressure shown on the pressure meter is 50 higher than the set patient pressure and in the interval between min 20 mbar and max 55 mbar To check the high pressure alarm PRESSURE 30 so mbar VCV mode MAX 1 Set the alarm level for high pressure to 30 ae Se ae mbar see page 44 a 2 During the inspiration phase start pressing the reservoir bag to alert the high pressure alarm POWER by imitating for example a cough The audi sees su ble alarm will start on the third inspiration RATE exceeding the alarm level for high pressure BATTERY 3 Control the pressure meter to see at what pres sure the high pressure alarm starts 4 Compare the pressure shown on the pressure meter to the set alarm level for high pressure 5 Readjust the alarm level to its original setting Inspiration trigger check To check the inspiration trigger 1 2 INSP TIME os __ 5 Sec INSPTRIG orr20 5 8 mbar PLATEAU L fen EXP TRIG 10 so Create a negative pressure in the patient circuit Check that the Insp Trig LED shows a green light and a breath is started Doc No 003 176 En Issue X 1 BREAS MEDICAL Page 51 Complete function check 11 7 11 8 11 9 Page 52 Expiratory trigger check The expiratory trigger check can only be performed in the PSV mode To check the expiratory trigger EXPTRIG w 10 VOLUME o 0 5 16 POWER M 1 Create a pressure in the patient circ
73. ster increase and therefore a longer plateau Inspiration trigger Insp Trig The inspiration trigger setting is used for defining the pressure at which the patient ini tiates a breath assisted by the ventilator BREAS MEDICAL Doc No 003 176 En Issue X 1 Operating Manual PV 403 PEEP Ventilation modes and parameters When the patient starts a breath a negative pressure is created in the patient circuit It is registered by the ventilator that immediately starts an inspiration If the patient cannot trigger a breath the ventilator will automatically take over and deliver breaths according to the set rate Expiratory trigger Exp Trig The expiratory trigger setting is defined as a percentage of the maximum inspiration flow This setting is used only in the PSV mode The ventilator measures the internal maximum flow during the inspiration When the flow drops below the set percentage of the expiration trigger setting the inspiration phase stops and an exhalation phase starts The expiratory trigger setting allows the tidal volume to be matched to different types of diagnosis compliance A low percentage gives a relatively larger tidal volume A high percentage gives a relatively lower tidal volume Tidal volume The tidal volume setting controls the volume delivered by the ventilator at each breath This setting is only used in the VCV mode PEEP Positive End Expiratory Pressure The PEEP setting is used for controlling
74. t and the ventilator alarms at start up The power cord is not properly connected Connect the power cord Check the connec tion at the rear of the ventilator and at the power socket If the fault persists contact service personnel The PV 403 PEEP does not run from the external battery The external battery cable is not connected properly or is faulty The external battery fuse is blown The fuse blows immedi ately after connecting the external battery cable Connect the cable Check for open circuit and replace the cable if necessary Replace the fuse Check the polarity of the connector If the fault persists contact service personnel The PV 403 PEEP does not run from the internal battery The internal battery is incorrectly installed or has not been properly charged A fuse has blown Contact service personnel The ventilator does not give adequate pressure volume Leakage from the patient circuit or the mask The filter is dirty The PEEP function may have been activated or switched off without your knowledge Check the tubes mask and exhalation valve for leakage Check the pressure line green for humidity and dry if humid Clean or replace the filter Check the PEEP function If the fault persists contact service personnel Doc No 003 176 En Issue X 1 BREAS MEDICAL Page 61 Troubleshooting Operating Manual PV 403 PEEP Proble
75. tidal volume and rate in the VCV mode is outside the ven tilator s working range the correct tidal volume will always be delivered but the actual rate may be incorrect On the settings panel the Volume and Rate LEDs will thus flash as a warning To stop the warning indication 1 Press the Function button until the Rate or Vol ume LED is lit 2 Press the buttons to adjust the settings for rate or volume PRESSURE 6 20 s _ mbar RATE 4 20 BPM INSP TIME os 3 3 s Sec INSP TRIG orr r0 5 s PLATEAU L Bon EXP TRIG 1 so VOLUME o 0 75 5 Litres POWER M PEEP Doc No 003 176 En Issue X 1 BREAS MEDICAL Page 41 Setting the PV 403 PEEP Operating Manual PV 403 PEEP 9 13 Setting the PEEP function The PEEP setting is used for controlling the patient s airway pressure during the exhala tion phase If the PEEP function is activated the ventilator keeps a positive end expira tory pressure when the patient exhales n Do not use the internal PEEP function together with an external PEEP valve on the patient circuit Setting range 0 mbar to 10 mbar To set the internal PEEP function EXP TRIG 10 50 1 Press the Function button until the PEEP LED VOLUME o 44 15 Litres is lit POWER M 5 PEE 2 Press the buttons to adjust the PEEP set ting 9 14 Incorrect settings for pressure and PEEP If the set patient pressure in the PCV mode or the PSV mode is lower than the set PEEP value the Pressure and
76. tolerance 4 of max value and 8 of actual value Analog output 0 6 V Digital output PC connector Alarm output Connector for external alarm equipment Power supplies Specifications Mains supply 100 240 V AC 50 60 Hz 0 8 A External battery operation 12 V or 24 V DC max 4 A Issue X 1 BREAS MEDICAL Page 65 Technical specifications Operating Manual PV 403 PEEP Operating conditions Specifications Operating temperature range 5 to 35 C 41 to 95 F Storage and transport tempera ture 20 to 60 C 4 to 140 F Ambient pressure range 700 1060 mbar Humidity lt 95 Indications Specifications Mains Green Power LED Green On Off LED M in power field on LCD display External battery operation Flashing green On Off LED E in power field on LCD display Internal battery operation Flashing green On Off LED TV in power field on LCD display Inspiration Green LED Trigger Green LED Lock function Green LED Alarms Specifications Auditory alarm signal pressure 60 dB A 5 dB A Measured at 1 m Power failure Red LED continous audible alarm message on LCD display Low pressure Red flashing LED high priority audible alarm flashing down arrow in pressure field in LCD display High pressure Red flashing LED high priority audible alarm flashing up
77. uit run ning the ventilator in normal operation 2 Set the expiratory trigger to 10 see page 40 On the LCD display check the mea sured tidal volume delivered by the ventilator 3 Set the expiration trigger to 50 and check the measured tidal volume again Operating Manual PV 403 PEEP Litres PEEP The measured tidal volume should be lower when the expiration trigger is set to 50 Tidal volume check This check is done in the VCV mode and only if you have a volume meter at hand To check the tidal volume 1 Check the tidal volume setting on the display EXP TRIG 10 50 VOLUME o 0 5 16 Litres 2 Connect the volume meter to the POWER M PEEP PV 403 PEEP 3 Check that the delivered tidal volume dis played on the volume meter is equal to the set tidal volume Alarm check low tidal volume This check is done in the PSV and PCV mode To check the alarm for tidal volume 1 Press the Alarm set button EXP TRIG 10 50 2 Select the tidal volume parameter see VOLUME o 91 16 Litres page 45 POWER QUIT PEEP 3 Set the alarm level for low tidal volume to 0 1 4 _ Exit the alarm setting function 5 Block the patient circuit 6 Check that the red alarm LED for volume flashes and POWER an audible alarm is given when the tidal volume has ee PRESSURE dropped below the set alarm level for more than 15 sec Seii onds BATTERY 7 Readjust the alarm level to its original setting BREAS MEDICAL Doc No 003 176 En
78. up the combustion of flammable materials o When oxygen is added the tidal volume delivered by the PV 403 PEEP increases slightly and thus the tidal volume setting needs to be adjusted in VCV mode In addition the trigger sensitivity may need to be readjusted Oxygen source An oxygen concentrator or an oxygen container with a flow meter can be used as an oxy gen source Follow the instructions below when applying the oxygen source Oxygen must be added via a BREAS oxygen adapter only The tube connection of the oxygen source should meet the requirements of the har monised European standard EN 737 0 Naked lights and other sources of ignition must be kept well away from the cyl inder at least two meters Oxygen monitor The oxygen content of the inspiration air should be controlled continuously using an oxygen monitor with both visual and audible alarms Follow the instructions below when using the oxygen monitor The lower and upper alarm levels must be set according to the doctor s medical instructions The oxygen monitor should meet the requirements of the ISO 7767 standard and the CE directives and MPG for the German market Read carefully the supplier s operating instructions for the oxygen monitor before use Pressure limiter When oxygen is supplied a pressure limiter should be installed between the patient air outlet and the patient circuit to prevent pulmonary injury Doc No 003 176
79. vice This way any signal from the ventilator s audible alarm can also be given through the external alarm equipment Follow the instructions below when using the alarm connection e Only use equipment approved according to the relevant IEC standard If in doubt consult the technical service personnel or your local BREAS representative o A function test of the connected alarm equipment must be performed before using the alarm the first time and then at least every 24 hours in continuous operation Switching the alarm connection The alarm connection setting can be changed to suit the external alarm device o The alarm connector settings must be adjusted by authorised service personnel only To switch the alarm connection 1 Switch off and disconnect the ventilator from the power source 2 Unscrew the alarm connector 3 Use a pair of pincers to move the plastic jumper J1 and or J2 to the desired position 4 Replace the alarm connector Doc No 003 176 En Issue X 1 BREAS MEDICAL Page 69 Technical specifications Operating Manual PV 403 PEEP The following are the settings of the alarm connector J2 position B 10 K ohm in series with the relay output default setting J2 position A Resistance short circuited J1 position A At alarm the relay closes J1 position B At alarm the relay opens default setting RELAY OUTPUT REAR PANEL ALARM RELAY K4 ALARMING 10 K ohm B PL B

BREAS PV 403 PEEP

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