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iVent201 Service Manual

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1. Before Pressure Adjustment After Pressure Adjustment Manometer Reading 58 cmH20 Figure 5 5 Calibrate Pressure Sensors 5 4 5 4 PEEP RPM Connect the test lung to the patient circuit 2 From the Calibration window select the Calibrate PEEP RPM option and press Start 3 Waituntil the calibration is finished for about 50 seconds The message Working flashes on the screen during the calibration step Issued 15 Aug 05 83 i m Figure 5 6 Calibrate PEEP RPM 5 4 5 5 Flow Sensor Disconnect the test lung from the patient circuit From the Calibration window select the Calibrate Flow Sensor option and press Start 3 Wait until the calibration is finished about 15 seconds The message Working flashes on the screen during the calibration step Figure 5 7 Calibrate Flow Sensor 84 VersaMed Vent2o1 Service Manual 5 4 5 6 Volume 1 Remove the plug from the patient circuit and connect the 500ml calibration syringe 2 Push the syringe piston all the way in to place it into a starting position 3 From the Calibration window select the Calibrate Volume option and press Start 4 Pump the syringe 10 times slowly and steadily each stroke should last 1 5 2 seconds The system counts the cycles displays the final values and then exits automatically At the end of each cycle both the inhale and exhale volume will update After the 10th count these values should
2. 69 AC power disconnect 31 Cepal 34 A eig aceiri A EE 31 description P E ENE E 34 battery disconnect 32 disposal iio 72 CP DIEE orrian 32 DOUG E A AN 72 73 77 inhalation exhalation 31 maintenance cccccccesescsessceeess 73 inspiratory pressure 31 gauge initialization 136 37 leak cte a ste uud 31 o i To ties IN MN RUN 32 LOW atte ly ceassco eee ts atedt irte 32 level indicator 35 low tidal volume 31 maintenance 34 74 75 78 TUL vol mensa 31 recharge HMC nase cea detis teu 28 over temperature oo eee 32 Bal CEN a 34 ORY SEN 31 A 91 patient circuit disconnect 31 VOIE ON 62 patient disconnect 31 Wa niodo osea Ed 28 patient disconnect alarm test 104 blower assembly 46 49 52 53 54 Press Usb 79 calibration 21 74 78 87 143 151 162 respiratory Tate insisti 31 165 sensor disconnect 32 diagnosis of observed low sensor disconnect alarm test 105 pressures during 162 A EE EAEE 32 flow Sensor coo ovooceccecccccceccecee 79 84 pis T 90 91 22 99 102 Or system eR RESI ANTA UA EAE 79 85 86 tube disconnect 31 PEEP REN i eee eee ne 83 tube disconnect alarm test 103 104 pressure sensors 79 82 vol
3. eren nennen nnn nnne nnus 75 32 1 SOO Four PM eenean radial 76 9 2 AAA 76 A Nte 77 PER E ae 015 E aa A A 78 II ror Te a O 78 5 4 Calibration Procedure c cecececececeneececececececeneecececececeneaeeceneaeaeaes 78 ER E E S EE AE A E E E E E MUN 79 Dd CODO ien a ET T T T SA 79 Dd Tools c EQUIPO rdiet Ta A Ovi aao DRE 79 SAATA RR ER TENER 79 O E eee eh eue ee UE e e 79 525 1 InittallZatlOfks omues tesis nere ahh a oat mes cuve endis 80 e 5 2 Zero SetiSOE S ean aaa ra iscsa dim E ED Ml LR EI INC DD LM D eL AE 81 54 59 Pressure Senso ta ud 82 Bod sd PEEP RP M adieren ETE E oc eU Spe ssevomedtervas deex utes ec Lotes 83 54 5 5 BIOW SONS OK totis ceti teteienta eee chic ieee 84 GPL Sa o RR IRR RR ER 85 S NM DN SUC IN M vals E A E E E 85 5 4 5 8 Save New Calibration cccccseccccccccccccccecccccccccacccccsccueceeeeseeaes 86 Section 6 Ventilator Test Procedures 88 6 1 Operational Verification Test s 88 SIN PU OSC caps ies ha E E naan se vetted EEE 88 OZ velo dM as 88 oye Frc TOS amp EquIDISELIE sri I TS 88 6 1 4 Initialization oe rer EE bod qu Re es 88 6 1 5 Proced ITO oie a dc M RM LLLI 88 6 2 Ventilator Verification Test VVT Procedure 90 SEVA MI Irure Nc EUH 90 D 2 719060 rita nr ti mas dod tut tuu ecu deese denied 90 6 2 3 Tools S EGU PME cR 90 6 2 4 InitialiZation
4. 162 Appendix A Parts and Accessories 164 Appendix B Service Report Form 166 Illustrations Isure 1 1 The Vento LEOTE VIEW uste ii e patina E gU lid 19 Ligure L 2 Thel Ventoy rear VIG W secat cuspodtecespoextup ane dcun sontes licores 20 Figure 3 1 External AC and DC POW llas 34 Figure 3 2 Oxy cen Inlet Comme ct On salda 36 Figure 3 3 Low Pressure Oxygen Supply System eese 37 iure oA aten bc iaa 38 Pearce 5 5 Patient Circuit Connech Oi A0 E1gure 0 PUSE SA toties aui 43 FIG UPS 9 7 VCE ALON CONTOS sionin a A Ded cele 44 Iisure4 I Eneumatuec DIDI uu e dana 47 Iugure 4 2 Phneumadtuc UNI OVer vie Willi 48 Figure des Electronic Module cdta ista ou Cd ius 97 Figure 4 4 Ventilator Overview uccisi tad verear toe iii 98 Figure 5 1 Cooling Vent left and Cooling Air Inlet Filter right 76 Figure 5 2 Entering the Maintenance Menu eese eee 81 Figure 5 3 Entering the Calibration Mens la 81 PIC ULC od AO DEN tede telam te Dicta e pa tura NEN Ee TRE di Uto e MER TER 82 Lieure 5 5 Calibrale Pressure Senso utensilio 83 Figure 5 0 Calibrate PEE PIE NN castas RON oan da 84 Pre aires 5 d Cali bate Porco 84 Fiure 5 5 Calibrate VOLS 85 Pieire s Capra te Oye saluos 86 Figure 5 107 Save Calibration sereia AETA A 87 o A sera ci ceatge cectitasotysmbua se catia hooattuot amisan gc amtas ss cameehi easteytcesansec
5. 1 Clean the rear cooling vents and the front cooling air inlet using a vacuum device Tilt the ventilator back to access the front cooling air inlet filter see Figure 5 1 page 76 2 Fully discharge then recharge the internal battery and allow the battery gas gauge to measure the total battery capacity as outlined in Section 7 5 page 136 3 Perform all 500 hour PM steps piesietas O O breath arm a o os al am charg e Figure 5 1 Cooling Vent left and Cooling Air Inlet Filter right 76 VersaMed Vent201 Service Manual 5 2 3 Annual PM The following steps should be carried out annually 1 Disassemble the ventilator enclosure as outlined in steps 1 9 of Section 7 4 Perform steps 1 9 only since the LCD cable does not need to be detached for this service 2 Remove the used cooling air inlet filter and install the replacement filter see Figure 5 1 page 76 and Figure 7 7 page 116 Be sure to examine the installation from the front and verify that there is adequate coverage of the air intake opening 3 Remove the existing air inlet muffler as outlined in Section 7 4 5 2 steps 3 amp 4 4 Install the replacement air inlet muffler as outlined in Section 7 4 5 3 steps 10 12 5 Remove the 3 3mm x 8mm Phillips head screws and washers from the outlet port mounting ears 6 Remove the existing outlet port and install the replacement port with the 3 screws and washers 7
6. Performance Turbine is Unit appears to Turbine is Replace Pneumatic Call Service for noisy pressurize deteriorating Unit Parts normally mechanically 142 VersaMed Vent201 Service Manual Symptom Possible Cause Part Number No blower pressure or turbine doesn t turn Error Codes 345 347 in technical log Defective Electronic Module Replace Electronic Module Defective Replace Pneumatic Call Service for Turbine Unit Part Call Service for Part Fails O2 Error Code 375in O sensorrange Replace O sensor 130B0002 Calibration technical log is inadequate Slow rise or decay of pressure on graph and PIP bar Error Code 360 found in technical log Unit won t pass OVT Fails OVT Patient Circuit Failed Unit displays Patient Circuit Failed alarm during normal operation Kinked or pinched internal sensor tubing Measurement values are slow to change but actual ventilation sounds normal and fast Unit passes VVT and Functional Tests Sensors Disconnect alarm was generated Flow offset on graph Sensing lines of patient circuit partially contaminated with fluid Internal tubing is contaminated with fluid Flow offset on graph with different circuits Missing or non functioning one way valve Sensing lines of patient circuit partially contaminated with fluid Pressure graph waveform is noisy 8 2 Diagnostics and Repairs
7. 11 Detach the green LCD cable ground wire from the LCD shield by removing the 1 3mm x 14mm Phillips head screw and lock washer located in the corner near the LCD connector 12 Use the nutdriver to remove the 2 4mm lock nuts from the LCD connector location on the front enclosure see Figure 7 7 page 116 Remove the aluminum U shaped bracket from the LCD connector site and pull out the LCD connector and cable 13 Remove the aluminum U shaped bracket from the LCD connector site and pull out the LCD connector and cable Issued 15 Aug 05 115 Top Screws 2 Bottom Screws 2 LCD Cable Ground Point LCD Connector Inverter Cable Encoder Cable Connector opeaker Connector opeaker MEMOTE ALARM IB nu LCD Shield Sensor Line Fittings Figure 7 6 Enclosure Rear View 1 Ground Wire Ribbon Cable Connector Interface Board Cooling Air Inlet Filter Figure 7 7 Front Enclosure Inside View 1 116 VersaMed Vent2o1 Service Manual Inverter Connector Electronic Module Ribbon Cable Sensor Lines LCD Cable O Sensor Pneumatic Unit Outlet Port Figure 7 8 Rear Enclosure Inside View 1 7 4 3 3 Enclosure Assembly 1 Position the front enclosure face down on a protective surface so that it is upside down and to the left of the rear enclosure assembly Plug in LCD connector cable into the connector located through the LCD shield Install the U shaped alum
8. 3006000201 Extemal Battery Charger 220VAC 01000101 Estemal Battery Case 630B0007 01 External Battery Holder for Roll Stand 3 iVent201 Service Manual OM 01 04 Nent201 Operator s Manual Appendix B Service Report Form The following 2 pages are the Service Report Form This form should be copied utilized and remitted to Versamed whenever a PM upgrade or service is performed on a ventilator 166 VersaMed Vent201 Service Manual SERVICE REPORT COUNTRY WARRANTY CONTRACT CUSTOMER NON WARRANTY BILLABLE IV NUMBER MACHINE HOURS SOFTWARE VERSION SERVICE TYPE REPAIR UPGRADE PM PROBLEM REPORTED FOUND ACTION TAKEN PARTS USED Issued 15 Aug 05 167 FINAL TESTING CALIBRATION PASS FAIL OVT PASS FAIL ENDURANCE TEST for 2Hrs PASS FAIL VVT TEST PASS FAIL TRIGGERS With PEEP 20 and Max PASS FAIL OXYGEN CHECK 70 100 PASS El FAIL BATTERY INDICATION PASS FAIL TECHNICIAN NAME SIGNATURE 168 VersaMed Vent201 Service Manual Index AQCLU d OE serrana da 51 147 148 battery 21 22 28 29 33 34 35 63 65 Sib gs baile O PE O O 24 36 54 07 66 69 72 73 19 76 77 133 134 l 136 137 139 140 162 See also power maintenance 74 76 77 pack ie notes toe 25 062 sige el cds capaci pd 28 73 E MINS EMEN 31 charger block
9. Calibration Screen Maintenance Menu Calibration Menu Figure 5 3 Entering the Calibration Menu 5 4 5 2 Zero Sensors 1 From the Calibration window select the Zero Sensors option The Zero Sensors window will appear 2 Disconnect the test lung and Rp20 resistor from the patient circuit and press start 3 Wait until the calibration is finished for about 6 seconds The message Working flashes on the screen during the calibration step Issued 15 Aug 05 81 po SIMU Uctrl Cali ae is Zero Sensors Disconnect the test lung from the patient circuit G Press START when ready E Cancel Figure 5 4 Zero Sensors I A L A 5 4 5 3 Pressure Sensors 1 Connect the reference manometer to the patient circuit Be sure that the manometer tee is capped so that there is no flow out of the unit 2 From the Calibration window select the Calibrate Pressure Sensors option and press Start 3 Adjust the value in the Manometer Reading field so that it equals the pressure measured by the external manometer and press the control knob to enter the new value Since repeating the Pressure Sensors calibration step will not display the value that was just entered it cannot be used to verify the pressure calibration The pressure calibration may be verified by the Ventilator Verification Test See Pressure Tests page 93 82 VersaMed Vent201 Service Manual
10. Replace Power Pack fuse 15A 137A0153 Fails VVT Battery capacity Replace Power 503A0012 Battery check is inadequate Pack or battery LCD connector is partially dislodged Display image is upside down reversed monocolored fuzzy etc Display is dim or flickers Unit power up sequence is normal but the display is black Buzzer is audibly too low in volume Screen Capture image is correct Display connector is connected adequately Can see correct image under extremely bright lieht Alarm Volume level is not adequate in options menu Defective LCD Display or Inverter Board Disconnected Backlight or Inverter Board cable Defective Interface Board Reconnect LCD connector and bend retaining bracket outward 503A0013 Replace Front Enclosure w LCD Reconnect Backlight or Inverter Board cable Replace Interface 506B0106 or Board 506B0006 140 VersaMed Vent2o1 Service Manual Symptom Possible Cause Solution Part Number Front LED Conductive Solntion _ away coating shorting coating from LED leads inside front enclosure doesn t light or is intermittent Defective Replace keypad 155K0003 keypad assembly Defective Replace Interface 506B0006 or encoder Board or Encoder 310C0002 Switch Assembly Cursor moves without touching control knob Control knob Encoder Tighten Encoder feels loose or mounting shaft mounting shaft
11. EQUIPO lie 110 LOT LIOSCOUEG oops au nT PRIMUM a en em errr ene 110 7 3 Option Package Update eeeeeesee eren e enne 112 PAT DOSE D UM 112 9 2 DE ODO iust eng and aa Ono Dp Don Oc ditio tod one d uoDo Doo uut Oa Sod ow Dro e Tau 112 LA 10015 G amp EGQUIDITIGDE o oto ed T tust E 112 V AT FOCA UTO tinet ds NM a ta Es IUIUS 112 7 4 Ventilator Disassembly and Assembly 114 FILM EUA ol ol cere werent 114 fo 2 PE ODO T P 114 7 4 3 Enclosure Disassembly amp Assembly sess 114 74 gt Tools S EQqUIDIBOBLU aaepe t DR A 114 74152 Enclosure Disassembly n dod SU dutem e 114 7 55 5 Enclosute ASSORIDIN sees eei E DR tse leonum eS 117 7 4 4 Electronic Module Removal and Installation 118 AAA TOOLS Sc EQUIDIBODL tadas 118 71442 Electronic Module Removal siii 119 7 4 4 3 Electronic Module Installation sees 120 7 4 5 Pneumatic Unit Removal and Installation 121 EL OO ls Egui p MeN il ia 121 7 4952 1InetimateUnt Removal a 121 Zb55Ineumate Unit installato 123 7 4 6 LCD Assembly Removal and Installation 126 746 L Tools and Equipment iaa 126 744 62 LCD Assembly Removal scinni ninnaa 126 FAC S bCD Assembly Ins
12. Microswitch This limit switch detects when the O valve has reached an extreme end of the usable range It prevents mechanical jamming and prevents the control system from spending time in ineffectual ranges It is a short travel double throw switch with a roller type actuator It is usually in a closed state actuated by the high area of the cam When a gate limit point is reached 100 or 21 O the armature falls into a low spot on the cam This sends a signal to the control system The stepper motor reverses direction 40 steps resets the step count and awaits further instruction The geometric relationship between the rotating actuating cam and O valve requires precise alignment It is recommended that VersaMed service perform this task and subsequent verification tests This component is automatically checked during the VVT Issued 15 Aug 05 51 4 1 2 6 Oxygen Sensor The oxygen sensor is a galvanic partial pressure sensor that is specific to oxygen It measures the O concentration of the gas mixture at the output of the blower This value is then used to adjust the O blender to a higher or lower position to match the targeted FiO The nominal sensor life is rated at 1 000 000 O hours This means that the sensor is expected to last for a little more than a year exposed to 100 O continuously or 5 years exposed to ambient O The voltage output from the sensor changes proportionally with the partial press
13. Pressure Test Results 6 2 5 3 Flow Tests 1 Remove the plug from the patient circuit and press OK 2 Waituntil the test step is finished about 6 seconds The VVT Instruction window will appear Figure 6 7 Flow Tests 6 2 5 4 O Tests 3 Verify that there is no O supply connected to the ventilator and press OK 4 Wait until the test step is finished about one 1 minute The VVT Instruction window will appear 94 VersaMed Vent2o1 Service Manual Figure 6 8 O Tests 21 5 Connect the O supply to the ventilator and press OK 6 Wait until the test step is finished about two 2 minutes The VVT Instruction window will appear Figure 6 9 O2 Tests 100 6 2 5 5 Battery Test 1 Disconnect the AC power cable from the ventilator and verify that the amber charge LED is off and the AC plug icon is crossed out 2 Press OK and wait until the test step is finished about 20 seconds The VVT Instruction window will appear Issued 15 Aug 05 95 Figure 6 10 Battery Test 6 2 5 6 Watchdog Timer Tests 1 Reconnect the AC power cable to the ventilator and press OK The Ventilator Verification window will appear Figure 6 11 Reconnect AC Power 2 Press Finish and wait for the test steps to finish about 1 minute During this time the ventilator will restart The System Message window will appear stating that the Ventilator verificati
14. The Vent201 can use medical oxygen from a cylinder or from a central supply system at 40 60 psi When the ventilator is ready for operation connect the oxygen supply to the male DISS oxygen connector on the back of the ventilator see Figure 3 2 page 36 WARNING To prevent hazard of explosion always make sure the oxygen connector is free from oil Issued 15 Aug 05 35 CAUTION Before connecting the ventilator to an oxygen supply verify the oxygen supply has the correct pressure range as specified above in Section 2 1 4 page 28 Periodic verification of the accuracy of oxygen concentration is highly recommended E Oxygen DISS Inlet Connector 100138 Figure 3 2 Oxygen Inlet Connector 3 3 2 Low Pressure Oxygen Supply When a high pressure oxygen source is not available the Vent201 can accept oxygen from a low pressure oxygen source such as an oxygen concentrator or flow meter This is accomplished by using an optional low pressure oxygen enrichment system that is attached to the ventilator air inlet port through an optional VersaMed adapter see Figure 3 3 Low Pressure Oxygen Supply System Adjust the flow of oxygen to reach the desired value of FiO2 The measured value is displayed in the FiO field in the Main window upon selection of Low Oxygen Supply Pressure option in the Advanced Settings menu The FiO value can also be measured with a calibrated external oxygen analyzer 36 VersaMed
15. cccccccsccccccccccccccccccucccccccccccccaucccuceceucccuecesausccuccceusecs 90 OE AKOTE E S LV i i PAEA EEE EA EAA AA TEA AT 90 62 5 Tati cound Tests ooo cies vetet T E A AA 91 02502 Pressure Testo a a a EEA 93 0 2 5 9 FOW ToS A TE 94 5 2 5 4 95 Tests oenina a e a a e iaeiei 94 200 Battery Testa aaa as 95 62 526 VW atehdos Timer Les Sacate 96 6 3 Functional Verification Test Procedure 98 SES Mi eL ol ofc ohne NOE cc E t 98 Dz CODO e aid 98 63 10015 EGU MeD Eerens init 98 A Oee a a a ved a Tii 98 Oo Procedur A E AES 99 6 9 5 L Delivery and Linea e dog a ee adeo dede 99 5 9 5 2 10070 Oo SUCHOI TESE cesta a related qetitone ovs a engine 100 00 00 Sale ALIS Testa 102 ban Eloy Pressure Mat a tana 102 E A gl arc ya icy A EN 102 6 3 5 3 3 Tube Disconnect AlarM ccooccnnnccnnnocnnnnonnononnnnocnnnnnnnnaconnnoso 103 6 3 5 3 4 Patient Disconnect Alarm eere 104 6 3 5 3 5 Sensor Disconnect Alarm eere 105 Section 7 Service Procedures 106 7 1 Software Upgrade Procedure eese 106 VI T EUPDOSE A n ated Serre a t ern icem ient diss 106 ASCO S cb dE MT ailes Mv duo MI v rec A E D n DE 106 LOOSE qu Ca 106 dod PROCOC UES A exui dator i ime Uds 107 7 2 Technical Logs Download se 109 A o OD v Det dE CIE M 110 DD A 110 2 LOCOS
16. to change a defective power switch you do not have to desolder wires The contact assembly will slide out of the back of the switch body see Figure 8 1 Press Here to Release Gray Body Style Press Here to Release Black Body Style Figure 8 1 Power Switch Assembly 144 VersaMed Vent201 Service Manual 8 2 2 Demand Valve There are two 2 versions of the demand valve One has a manual actuation button and the other does not The unit with the button needs a slight positive pressure 2 cmH20 to shut off the flow while the other version will shut off automatically just from the small amount of back pressure present at its output connector This component can be verified for proper function independently 1 Connect an O2 supply to the DISS fitting of the demand valve and apply 50 psi 2 Initiate a flow though the device by actuating the manual button found on top The unit without the button can still be actuated manually by gently pushing a small diameter rod through the center hole on top 3 Using the palm of your hand slowly occlude the demand valve outlet and verify that the device shuts off flow with no appreciable buildup of back pressure 4 Verify that the device remains off and there is no perceptible leakage Some demand valves will shut off as soon as manual actuation is lifted While this is normal nevertheless there should be no detectable leakage If the demand valve functi
17. worn out nut is loose nut Error code 316 User pressed a Instruct users to found in error key on the make momentary log keypad or selections control knob for more than 5 seconds Keypad is Replace Keypad 155K0003 defective or Assembly intermittent Unit displays Error Code 304 in Cooling fan Reconnect cooling temperature technical log disconnected or fan or repair error defective contact connector contact Cabling Reroute wires interfering with away from cooling cooling fan fan and secure Fails VVT Solenoid valves Defective contact Repair contact Solenoid failure able to move on Main mechanically Pneumatic Error code330in connector Pneumatic Unit Unit part Fails VVT Flow Patient Circuit Pneumatic leak Replace Patient 620B0006 sensor leak connections to the atsensing tubes Circuit front panel are connection secure Pneumatic leak Locate internal at internal tubing leak See tubing Section 8 2 5 Defective Replace Electronic Call Service for Electronic Module Part Module Fails VVT PIP reaches lt 65 Unit out of Recalibrate Zero Blower or cmH O during calibration Sensors and Patient VVT Pressure Sensors Issued 15 Aug 05 141 Symptom Possible Cause Part Number Pressure PIP reaches 65 Outlet Muffler is Replace Outlet 504A0111 cmH 5O during broken and Muffler VVT and unit is leaking Ventilator Outlet calibrated Fails VVT O O supply
18. yamg Jagd jguondo zods mo wieg 24903 DJEcqABM F 39 4138 Jo euondo Lno INI 2 esu INQ O3PIA VersaMed Vent2o1 Service Manual 58 4 2 1 Computer The computation platform of the electronics system is an embedded PC with an AMD 5x86 133 processor The standard PC components of memory serial ports floppy and IDE drive support and VGA support are present In addition the CPU board is embedded with such PC specific features as watchdog timer LCD display support and PC104 bus The exposed connectors on the back panel of the ventilator are for a keyboard RS 232 serial port and a VGA monitor Other interfaces are only used for debugging The CPU board interfaces with the main board via the PC104 bus and also receives power through the power connector from the switching board The CPU board connects directly to the LCD display and is also connected to a buzzer on the front panel Some CPU boards may have ethernet connectors This port is not utilized at this time 4 2 1 1 System Memory System memory consists of FPM EDO onboard 8MB SIMM x 1 In addition to the standard locking socket a bracket is used for increased mechanical security Newer ventilators S N 1900 and higher use 32 MB SDRAM 4 2 1 2 BIOS The flash BIOS with VersaMed Logo supports CRT TFT LCD display DiskOnChip PC Watchdog etc 4 2 1 3 DiskOnChip M Systems DiskOnChip r is a flash device used to store the Ventooi
19. 12V 7 2 9 Ah rechargeable Recharge Time 8 to 10 hours Operating Time Up to 2 hours varies with ventilation internal battery parameters 2 1 4 Oxygen Supply High Pressure 40 to 60 psi 2 8 to 4 1 bar 2 1 5 Size and Weight Height 13 in 33 cm Width 9 5 in 24 cm Depth 10 3 in 26 cm Display 8 4 in 21 3 cm diagonal Weight 15 4 Ib 7 kg without battery Battery Weight 6 5 lb 3 kg Overall Weight 22 Ib 10 kg VersaMed Vent2o1 Service Manual 2 1 6 Environmental Specifications Operating Temperature 15 to 50 C 5 to 122 F Storage Temperature 15 to 70 C 5 to 158 F without battery 15 to 30 C 5 to 86 F with battery Relative Humidity 15 to 95 30 C 86 F Water and Dust Resistance P54 splash proof Atmospheric Pressure 430 825 mmHg up to 15 000 feet Vibration IEC 68 2 6 IEC 68 2 34 MIL STD 810E Shock IEC 68 2 27 100G MIL STD 810E Total External Sound Level 40 45 dB A at one meter 2 2 Standards and Safety Requirements The Vent201 meets or exceeds the following international standards ISO 10651 2 Particular requirements for Home Care Ventilators ISO 10651 3 Requirements for Emergency and Transport Ventilators ASTM F1100 90 Standard Specifications for Ventilators intended for use in Critical Care IEC 60601 1 Electrical Safety IEC 60601 1 2 Electromagnetic Compatibility EMC IEC 60601 2 12 Medical Electrical Equipment Particular Requirements for
20. 2 Verify that a Theaudible alarm sounds continuously b Ared pop up Warnings window appears stating Sensor disconnect c There is a red Sens disc indicator in the lower left part of the display window d The mode field changes to a blinking OPEN LOOP oop l BACKUP MODE ACTIVATED Warnings Figure 6 21 Sensor Disconnect Alarm 3 Reconnect the flow sensor lines to the ventilator front panel and verify that the alarm automatically recovers Issued 15 Aug 05 105 Section 7 Service Procedures The following section provides step by step instructions for upgrading and servicing of the Vent201 including the disassembly and reassembly of the unit IMPORTANT It is extremely important that Versamed is kept apprised of all servicing activities that affect the final configuration of the unit including traceable components A form is provided in Appendix B to facilitate this This form should be copied from the manual filled out and remitted to Versamed whenever a PM upgrade or service is performed on the ventilator The form can be faxed to 845 770 2850 7 1 Software Upgrade Procedure 7 1 1 Purpose The purpose of this procedure is to provide clear instruction for the upgrade of the ventilator to a new software version 7 1 2 Scope This procedure applies to Vent201 Version 1 4 ventilators manufactured by VersaMed Medical Systems Inc and running software version 19 11 or hig
21. Alarm Sound Tests page 91 and Pressure Tests page 93 e if Flow sensor leak is Failed the cause is not the blower pressure or exhalation valve control tubes e if Flow sensor leak is OK the location of the leak is along the blower pressure and exhalation valve control tubes A leak that is located anywhere from the blower port tee to the blower pressure transducer will probably fail the Blower pressure part of the VVT but not the Flow sensor leak This suggests that the probable location of the leak is one of the following e the barbed connector just behind the front panel luer of exhalation valve control line or 152 VersaMed Vent201 Service Manual e thesmall barb of the blower pressure connection tee 8 2 5 4 Negative Flow Port vs Positive Flow Port The two bottom left side luer connectors on the front panel are the flow sensing ports The leftmost port is a metal male locking luer it is the negative flow port If this port is pressurized or it is at a higher pressure than the right port the flow graph trace on the display will go below the baseline The right port is a female locking luer it is the positive flow port If this port is pressurized or it is at a higher pressure than the left the flow graph trace will go above the baseline Again note that a leak along either branch will have the opposite effect if there is a leak along the tubing of the negative left side port the flow graph wil
22. Demand Valve e Proportioning Valve e Controller Valve Limit Switch e Oxygen Sensor Issued 15 Aug 05 49 4 1 2 1 O Pressure Switch The O pressure switch detects whether or not high pressure gt 10 psi is present at oxygen inlet The switch is normally open absence of high pressure O and closes with adequate pressure This component is automatically checked during the VVT 4 1 2 2 Demand Valve The demand valve s primary function is to reduce the pressure of oxygen from the nominal 50 psi found at its inlet to a 60 cmH20 potential The maximum flow of oxygen through this device is 120 Ipm Its second function is to open only if there is a negative pressure at its outlet If the valve were held open by mechanical means 60 cmH20 could be measured at the outlet however by definition any positive pressure will shut it off Therefore the 60 cmH20 of outlet pressure is only theoretical and not a part of normal operation The actual pressure at the demand valve outlet is approximately 0 cmH5O or ambient This component is automatically checked during the VVT 4 1 2 3 Proportioning Valve This is a gate type valve that slides between the O inlet port and ambient port of the pneumatic unit housing inlet manifold Each port is 22mm in diameter When the mixture is equal or 6076 oxygen the valve occludes about one half of each opening There is also a one way valve attached directly to the gate valve that directs f
23. O sensor Disconnect the main connector from the right side of the pneumatic unit by pressing in the side clips of the connector and pulling it out 8 Disconnect the power pack connector from the bottom right of the electronic module EM 9 Remove the 2 4mm x 8mm screws and lock washers from the electronic module mounting plate located at the top of the electronic module 10 Pull the entire electronic module out from the front of the unit Be sure to guide the O inlet cap and chain through the large opening at the rear of the enclosure The rear enclosure assembly can be tilted back so that it rests on the power pack handle Issued 15 Aug 05 119 Electronic Module Mounting Screws 2 Power Pack Handle Figure 7 9 Enclosure Rear View 2 EM Mounting Screws 2 Air Inlet Muffler Electronic Module EM Ground Wire Power Pack Connector O Sensor Connector Main Connector Blower Pressure Pneumatic Unit Sensing Tube Outlet Port Figure 7 10 Rear Enclosure Inside View 2 7 4 4 3 Electronic Module Installation 1 Guide the O cap and chain through the large opening at the rear of the enclosure and slide the electronic module into the top cavity Be sure that the tubes coming out of the bottom of the electronic module do not kink or bind on the top of the pneumatic unit 120 VersaMed Vent201 Service Manual 2 Install the 2 4mm x 8mm screws and lock washers
24. The temperature measurement site is located in the center of the electronic module 4 2 2 1 5 Battery Voltage The battery voltage is divided buffered and presented without amplification or filtering to the ADC 4 2 2 2 Digital Analog Interface The interface between the software operating the system and the physical analog measurements made by the system is through an 8 channel 12 bit analog to digital converter ADC Writing command to the internal registers accesses the ADC and reading measured results from the internal registers The ADC voltage reference is a precision Issued 15 Aug 05 63 low noise integrated circuit whose output is buffered and also used by all analog components requiring precise voltage A 4 chamnel 8 bit DAC provides bias reference voltages to compensate for the offset voltages in the sensor paths 4 2 2 3 Control and Status Reading and writing registers access control and status features of the main board Most writable register locations are also readable The software recognizes the board as seven 16 bit registers 4 2 2 4 Motor Interface The motor interface consists of control signals to enable slow down and brake the motor a register for controlling motor speed and a register for measuring motor RPM A Programmable Logic Device Lattice PLD primarily controls the motor The PLD translates the value in the speed control register using PWM Pulse Width Modulation to generate the av
25. Vent201 Service Manual Figure 3 3 Low Pressure Oxygen Supply System CAUTION Use of the low pressure oxygen system at concentrations above 60 is NOT recommended as higher values combined with varying minute volume due to spontaneous breathing of the patient may cause inadvertent PEEP When using the low pressure oxygen system None may also be selected This option will disable both the internal O monitoring and alarms The FiO field will display 0 3 4 Patient Circuit The iVentz breathing circuit contains the following components Tubing Exhalation Valve and a Wye Flow Sensor see Issued 15 Aug 05 37 Control Line blue Exhalation Valve A S d y Exhalation Valve Enxpiratory Limb Sensor Lines ONS Q Inspiratory Limb One way Valve Expiratory Limb Exhalation Valve Exhalation Valve Control Line Patient Wye One way valve Sensor Lines Inspiratory Limb Figure 3 4 Patient Circuit The ventilator circuit is intended for single patient use only and consists entirely of disposable components A Heat and Moisture Exchanger HME should be used and placed between the flow sensor and the 38 VersaMed Vent201 Service Manual patient connection An adapter for MDI treatment user supplied may be placed between the flow sensor and the patient connection for the temporary administration of medication If an HME is also being used place the Metered Do
26. an electrical power supply failure is detected CAUTION The Vent must be used at all times with a properly functioning battery in order to ensure the correct operation of the ventilator 3 2 1 Battery Charging The internal battery is automatically charged when an adequate external power source is connected to the ventilator Prior to operating the ventilator for the first time or after prolonged storage of the unit 90 days or more the battery must be charged by connecting the ventilator to an external power source for a period of at least ten 10 hours 34 VersaMed Vent2o1 Service Manual After prolonged storage the battery charge level icon may indicate full The unit should still be charged for ten hours 3 2 2 Internal Battery Charge Level Indicator The internal battery indicator or charge level icon shows the status of the battery charge and is located at the bottom center of the display screen When the battery is fully charged the message FULL is displayed inside the indicator When the battery is fully discharged the work EMPTY is displayed inside the indicator Table 3 1 Internal Battery Charge Level Indicator Indicator Colors Description Green Clear Green portion of indicator moves across in 10 increments Changes to red when the Cm peeled measurement is less than 30 Clear Displays EMPTY when the measurement is less than 7 3 3 Oxygen Supply 3 3 1 High Pressure Supply
27. artificial higher exhale volume This issue is easily resolved by placing a bacterial filter at the outlet of the patient circuit wye 160 VersaMed Vent201 Service Manual Figure 8 11 Test Lung 190 and Vent201 Waveforms 8 4 Miscellaneous Issues Some issues cause misleading symptoms as described below 8 4 1 Black Screen Sometimes this symptom is reported as unit doesn t boot up or defective display Most of the time a black screen is a minor problem with the LCD backlight or inverter A disconnected or defective LCD displays an all white screen If the screen blacks out try reflecting a very bright light off of the screen surface and see if you can detect a dim graphical image If so generally the cable is unplugged or one of the three wires or connector contacts is disconnected or broken 8 4 2 Fails Calibrate Flow Sensor The unit fails the calibration step Calibrate Flow Sensor but most of the time it is in fact an O2 problem for instance the O mixer is in the 100 O position and the unit cannot generate the flow that it needs 8 4 3 Erratic O Control Normally when a FiO value is set the unit will seek the targeted O mix and stabilize If the control or stability of O2 appears to be erratic the root cause may actually be an unstable minute volume Usually the cause of an unstable minute volume is extra breaths being delivered due to auto triggering Auto triggering can occur fo
28. bottom of the electronic module to be discharged through the rear of the unit 4 3 LCD Display The LCD display is mounted to the front panel but connects directly to the CPU board which provides both power and data A 640 x 480 TFT color display is currently in use but other displays can also be used The display uses dual compact fluorescent backlights that require a high voltage AC source supplied from an inverter The inverter board is an off the shelf component which receives its 12V input from the switching board CAUTION The LCD inverter produces a high voltage Verify that the system is powered off before attempting to handle the inverter or components close to it Connection to the LCD panel is made using a 31 pin Hirose connector There is an aluminum bracket securing it in place Most display abnormalities such as reversed screens mono colors etc are remedied by resecuring this connector Issued 15 Aug 05 71 4 4 Interface Board The interface board receives input signals from the keypad and rotational control and transmits them to the main board The interface board also passes the LED signals from the main board through to the keypad audible alarm buzzer and speaker There are two 2 versions of the interface board One supports a speaker and the other supports a second buzzer 4 5 Power Pack The battery power pack is a removable unit which slides into the back of the ventilator and provides power w
29. directly from VersaMed call Y 800 475 9239 Customer Care and Service Assistance Line Or 866 483 6820 866 1V ent201 If you have a ventilator problem that you cannot solve and you purchased your ventilator from an authorized VersaMed distributor please contact your distributor directly to report the problem If this ventilator has not been purchased directly from VersaMed please ensure that it has been purchased from an authorized distributor of VersaMed To obtain a list of authorized distributors contact VersaMed at sales versamed com visit our website www versamed com Table of Contents Section 1 InNtrOdUCION mission 18 1 4 ONO OCG US RR A A RARA 18 iz General Descrip ati bid 19 TS Saf ty INTOFMATION a 20 to Sal Oly Resta cons asuntos sd 21 132 Techician padece 21 LS ZE lazard NOCES ai dl cn 21 1 3 2 2 Calibration and Verification Test 21 1 9 2 9 Handline TG Boards sssini ene A NEN 22 1 3 3 Important Safety Considerations eene 22 1 4 Labels and Symbols 1 e eeeeeeeeee eere enne nnns 23 E titu cuidas eue eer eee ere eee ues 23 FAZ rio c O a oes heat eaie teats pa esec touts 24 Section 2 System Specifications 27 2 1 Specifications ici 27 2 1 Ventilation Modest tibiae tee say aes nude ada 27 2 1 2 Ventilation Performance and Controlled Parameters 27 PAR IBS LOW SUD sida 28 RAA ndo oo o A
30. exhale tidal volume accuracy Cap DOSiS cunsistia 157 158 exhale tidal volumes A e Eee 162 o EEE pedites bored dan rend 40 O 41 170 O EAEE 41 54 bacterial teca cnn bs 40 41 43 Wastra ON toda 43 low pressure oxygen 41 maintenance cccccncnennnccnannnnnnnnnnss 76 Nuclear Biological Chemical NBC mm as 41 OXY O Car R E EERE 41 HOW mete aio 36 TOW a 62 66 fails calibration 161 SA 55 149 PUT iaa 67 flow transducer 62 66 151 Functional Verification Test 98 105 10076 O test sss 99 100 O System test aoo 99 100 safety alarms test 99 102 Heat and Moisture Exchanger HME TON DOE RUPEM 38 40 humidification TO AOC a ose niet a Ep t RR Re 56 inhale tidal volume accuracy danos ide 158 interface board 46 72 128 129 140 141 removal and installation 128 30 Verter Un dali edil 22 iVent201 calibration See calibration CO Doo ias 59 GODLFOL KHOD autore ERR 44 CESCLI PD HOM eener 19 disassembly and assembly 114 34 front panel controls 44 front panel LEDS 45 indicators and icons 32 VersaMed Vent20o1 Service Manual intended use sse 18 Kev pa daa 44 45 Ee ue tnm outta 32 maintenance s 4 78 OPETI OT ce ac picto oa 45 EOL een eats chiang 46 option pack
31. faster manipulation with the exhalation valve control line such as the Easy Exhale feature CAUTION When the patient circuit is used with active humidification the one way valve needs to be moved to the inlet of the humidifier water chamber to allow for proper drainage 4 2 Electronic Module The electronic module of the Vent201 ventilator is a computing and control platform with multiple functions enabling the built in software to operate the ventilator s pneumatic unit The electronic module senses monitors and displays the ventilation parameters It also controls interaction between the user and ventilator through the user interface The electronic module consists of the following components and sub systems see Figure 4 3 e CPU Board e Main Board e Zeroing Purge Board e Switching Board e Power Supply e Cooling Fan 56 VersaMed Vent2o1 Service Manual Zero Purge Board Main Board owitching Board Power Supply Figure 4 3 Electronic Module The following diagram shows how the electronic module components interact with each other and with the other components of the iVent20 Issued 15 Aug 05 57 uo aleyn wey anpa 3 JELUNAU d JowX4eads 043105 BUOoIeJOy Jazzng Dig pJeog 93EJ187U SUE 16014 USA 01971 ejdsig 21 pieog Bui23iMs pieog Wep piec Jd 93ug ur v Apddng Jamg alnpo py ynduj aT ynduj 50 Figure 4 4 Ventilator Overview
32. for 2 minutes without attempting to ventilate It will also deflect any errant signals the technician may create via extensive manipulation of the sensor tubing This setup can be especially handy for troubleshooting pneumatic leaks 1 Connectthe AC power and patient circuit to the ventilator 2 Turn on the ventilator and select the 70 kg patient weight setting in the opening screen 162 VersaMed Vent2o1 Service Manual 3 Highlight the mode field in the upper right hand corner of the display and select CPAP PSV The parameters setting window appears This mode does not require any mandatory breaths and the set rate defaults to zero 4 Select PEEP and adjust the value to 20 cmH20 If the ventilator is configured for Extended Ranges then you can adjust the PEEP to 40 cmH2O 5 Select Triggers and adjust both Press and Flow to Off 6 Highlight and select Accept 7 From the Main Menu select the Alarm Settings option The Alarm Settings window appears If no cursor movement is sensed by the ventilator for 1 minute it will timeout and return to the Main Menu 8 Select Apnea Time and adjust the setting to 120 sec 9 Highlight and select Accept in order to keep these settings The Standby screen appears 10 From the Main Menu select the Advanced Settings option The Advanced Settings window appears 11 Select the Purge Every option and set it to Off 12 Block the patient circuit wit
33. non volatile files contained within the ventilator The log files contain recorded data of events or errors that occurred during previous usages The files are accessed using a proprietary download utility named ivDownload The files are downloaded from the ventilator one at a time and are selected by a specific file name either events log or error log The files must be renamed after they are successfully downloaded from the ventilator onto the PC s hard drive in order to ensure that subsequent downloads can proceed and that no data is overwritten Issued 15 Aug 05 109 This function can be performed at any time that the ventilator is powered up including during ventilation This function should be performed only by a qualified technician 7 2 1 Purpose The purpose of this procedure is to provide clear instruction for the retrieval of the Vent201 error and event logs 7 2 2 Scope This procedure applies to Vent201 Version 1 3 and 1 4 ventilators manufactured by VersaMed Medical Systems Inc and running software version 9 xx or higher 7 2 3 Tools amp Equipment e PC running Windows 95 OS or higher with the new Vent201 software version installed and a free RS 232 port Coml to Coma e RS 232 communication cable DB 9 female female null modem 7 2 4 Procedure 1 Connect the RS 232 port of the PC to the RS 232 port of the ventilator using the null modem serial communication cable 2 Double click on
34. open configuration but is usually actuated by the high area of the cam The switch goes to an open condition when the actuator falls into a low area located on the extreme ends of the cam This component can be verified for proper function independently Issued 15 Aug 05 147 Microswitch Armature Disassemble the front enclosure from the rear assembly as outlined in Section 7 4 3 2 Enclosure Disassembly page 114 With the unit powered off manually rotate the shaft of the stepper motor so that the microswitch actuator is at an end position on the cam see Figure 8 4 Connect an ohmmeter to pins 7 amp 8 in the PU main connector Figure 8 5 and verify that the switch is in an open state Manually rotate the shaft of the stepper motor so that the microswitch actuator is at a mid position on the cam and verify that the switch is in a closed state Reassemble the front enclosure to the rear assembly as outlined in Section 7 4 3 3 Enclosure Assembly page 117 Figure 8 4 O2 Mixer Top View 148 VersaMed Vent2o1 Service Manual Figure 8 5 Main Connector Front View Microswitch Pinout 8 2 5 Flow Sensor Leak If you have replaced the patient circuit and verified that the plug cap or manometer that you are using to occlude the outlet of the patient circuit does not leak Most flow leaks occur at a tubing connection point Occasionally a connected component such as a pressure transducer check va
35. performance 6 2 2 Scope This procedure applies to Vent2o1 Version 1 4 ventilators manufactured by VersaMed Medical Systems Inc and loaded with software version 19 11 or higher This procedure should be performed after any repair calibration upgrade preventive maintenance or shipment 6 2 3 Tools amp Equipment e O supply 40 60 psi e O supply hose Versamed P N 620B0001 01 or 620B0002 01 e Cap 22mm supplied with every patient circuit 6 2 4 Initialization 1 Connectthe AC power and patient circuit to the ventilator 2 Turn on the ventilator and select the 70 kg patient weight setting in the opening screen 6 2 5 Procedure The VVT checks the functionality of the following ventilator components 90 VersaMed Vent2o1 Service Manual Alarm sounders two Patient pressure transducer and pressure performance Blower pressure transducer Transducer tubes leak Motor speed measurement Positive relief valves Solenoid valves two Solenoid safety release mechanism Flow performance Flow zeroing function 2176 F1O Pressure Switch status at 21 Demand Valve Leak 100 FiO Pressure Switch status at 10076 Dattery status Motor watchdog safety device PC watchdog safety device 6 2 5 1 Alarm Sound Tests jm From the Main Menu select the Maintenance option A Caution window appears stating that only trained service personnel should enter the restricted Maintenance area Select Yes and the Maintenanc
36. stamps can be reviewed by selecting Show Log Book from the Main Menu The typical run time under these parameters Is approximately one hour 9 Reconnect the AC power cord and place the unit into Standby mode 10 Allow the unit to recharge for at least 10 hours 11 Operate the unit normally and verify that the battery icon on the display indicates full Issued 15 Aug 05 137 Section 8 Troubleshooting 8 1 Troubleshooting Guide Prior to utilization of the following troubleshooting table it is assumed that the following basic steps and verifications have been implemented whenever possible Verify that 1 The unit conforms to upgrade changes mandated by Technical Notification TN distributed by VersaMed Medical Systems Inc including installation of the current released software revision Complete and remit any Field Change Order FCO forms supplied by VersaMed Medical Systems Inc 2 The periodic maintenance schedule is current and follows the guidelines outlined in Section 5 of this Service Manual and Section 8 of the Operators Manual 3 All external tubing cables and connections are properly secured and reliable 4 The OVT and VVT procedures have been conducted with all failures noted 5 The unit can be calibrated successfully and re verified by OVT and VVT 6 The technical log files error log and events log have been downloaded and archived Files should be e mailed to techsu
37. the Safety of Lung Ventilators Critical Care Ventilators UL 94 HB Flammability Issued 15 Aug 05 29 2 3 Monitoring and Displayed Parameters The following table lists specifications for all parameters the 7Ventz201 displays in each applicable mode whether set or measured Table 2 1 Displayed Parameters and Indicators During Ventilation Applies to Mode T E Lo measured mi mi cmH O cmH O min min cmH O cmH O cmH O cmH O cmH O min on Symbo con Symbo o Ext Ext on Fill Date Time eje e ejeje e jo M Manual mode only S Spontaneous breath measurement only A Adaptive mode only L Low O Pressure mode only V measured value only not settable MEDICUM el ae reni Tieras P See pispivea min Sy LAL eve ojojojojol fe jojojo jofjejmia Vpolviv fe MiA ll leje peleleoleleleole peleleolelelele ll feted jojo o feje ejojojo feje ojojojojol fe o jojojeje fe pelele LE LL pe epe TI Fm A 3 O Iz D O OCIS Lr O LIIL O IN OIO o 2 SES ODED PEPE O va 30 VersaMed Vent201 Service Manual 2 4 Adjustable Non Displayed Parameters Sigh Breath Interval Breaths 25 50 75 100 125 150 Off Rise Time Drive Mid High Max Auto Easy Exhale On Off Oxygen Supply Pressure High Low None Adaptive Peak Flow Off Low Mid High Purge Interval Minutes 1 2 5 10 Off 2 5 User Adjustable Alarms Res
38. the cap from the exhalation valve only and press Start The unit will pressurize briefly and then the alarm will sound while the O V T Confirmation window appears Remove cap on exhalation value onlu Leave cap on the WYE sensor riggers cm L GI 8 8 M Uol 4 8 NLFT JP Ais MENU Figure 6 2 OVT 2 4 Press Yes if the alarm is audible The O V T Results window appears Press OK and the unit will return to the Standby screen If the ventilator fails to pass the O V T verify that both caps are pushed onto their respective ports all the way Also verify that the flow sensor and exhalation valve control tubes are adequately mated to the front panel luer fittings and repeat the test Issued 15 Aug 05 89 CAUTION If the ventilator repeatedly fails the O V T replace the patient circuit and repeat the test If the O V T still fails after the circuit exchange then run the Ventilator Verification Test V V T described in the next section to isolate the specific failure mode 6 2 Ventilator Verification Test VVT Procedure The Ventilator Verification Test VVT is a set of simple ventilator self tests to check the ventilator functionality User intervention is required to alter various external connections to the ventilator as well as the confirmation of audible alarms 6 2 1 Purpose The purpose of this procedure is to establish a method of properly verifying the ventilator functions and
39. the file named ivDownload exe on the PC to start up the download application 3 Verify that communication is established the message CONNECTED TO COM number should appear at the bottom left of the application window If it does not check the RS 232 connection and cable You may also be required to select the appropriate COM port com1 to com4 from the Com menu 4 Type error log or events log into the Insert file name box depending upon which log file you wish to download 110 VersaMed Vent201 Service Manual Jll Download Application 3 lol x Fie Com Options Help Insert file name Qo Instructions Press the DOWNLOAD button to start dv vent Events Log CONNECTED TO COMM 1 Not Synchronized ll Download Application 10 x File Com Options Help Insert file name E i elg Download 8 Instructions Went SS j CONNECTED TO COMM 1 Not Synchronized Figure 7 4 ivDownload PC Application Screens 5 Pressthe Download button to start The message Downloading File please wait will appear on the PC 6 When completed the message Download ended successfully will be displayed in a pop up box on the PC 7 Press OK and the PC application will automatically close 8 Locate the file error log or events log that you just created in the appropriate PC directory 9 Rightclick on the file and select Rename from the pop up window Rename the file to IVxxx err
40. through the electronic module mounting plate located at the top of the electronic module Do not tighten the screws at this time 3 Install the 2 3mm x 8mm Phillips head screws to the rear of the enclosure see Figure 7 9 page 120 4 Tighten the rear and front mounting screws of the electronic unit Facing the front of the rear enclosure connect the green ground wire to the left side of the electronic module EM see Figure 7 10 page 120 6 Connect the O sensor connector marked cable 6 to the top of the O sensor 7 Connect the blower pressure sensing tube to the top of the outlet port 8 Connect the main connector to the right side of the pneumatic unit 9 Connect the power pack connector to the bottom right of the electronic module EM 10 Screw the green O inlet cap to the DISS fitting on the rear of the unit 11 Assemble the front enclosure to the rear enclosure as outlined in Enclosure Assembly Section 7 4 3 3 7 4 5 Pneumatic Unit Removal and Installation 7 4 5 1 Tools amp Equipment e Screwdriver Phillips 2 e Wrench Open End 11 16 inch e Wrench Open End 9 16 inch 7 4 5 2 Pneumatic Unit Removal 1 Disassemble the front enclosure from the rear enclosure as outlined in Enclosure Disassembly Section 7 4 3 2 page 114 Issued 15 Aug 05 121 Remove the electronic module as outlined in Electronic Module Removal Section 7 4 4 2 page 119 Remove the air inlet filter f
41. 1 Version 1 3 and 1 4 ventilators manufactured by VersaMed Medical Systems Inc and running software version 10 xx or higher 7 5 3 Tools Equipment e Test lung 2L Versamed P N 910V0005 01 e Pneumatic resistor Rp20 Versamed P N 910V0004 A0 7 5 4 Procedure 1 Plug the AC power cord into the ventilator verify that the amber charge LED comes on and allow the unit to charge the battery for at least 8 hours 2 Power up the ventilator and select the 70 kg patient weight setting in the opening screen Even if the battery icon doesn t show FULL it should be ignored at this time 3 Set the pressure alarm to 60 cmH O 136 VersaMed Vent201 Service Manual 4 Connect the Rp20 resistor and test lung to the patient circuit wye and then connect the patient circuit to the ventilator 5 Press START on the ventilator 6 Adjust the tidal volume Vt so that a PIP of at least 40 cmH20O is attained on each and every breath 850 mL is a typical value 7 Disconnect the AC power cord and remove the pop up window by pressing clear 8 Allow the ventilator to run off the battery continuously until the Empty battery alarm activates If the low battery alarm activates clear it and allow the unit to continue operation until the empty battery alarm The battery run time may be measured during this time by monitoring the time from AC disconnect to the empty battery alarm These events and their respective time
42. 28 IMSS e AM i n ana oi aai 28 2 1 6 Environmental Specifications eene 29 2 2 Standards and Safety Requirements 29 2 3 Monitoring and Displayed Parameters 30 2 4 Adjustable Non Displayed Parameters 31 2 5 User Adjustable Alarms eeeeee eere eene 31 2 6 Additional Alarms and Indicators 31 2O MP Fe G12 cian E O 31 2 6 2 Indicators and CONS DESTRUERE ee eae eee 32 Section 3 Installation and Setup 33 3 1 External Electrical Supply isccexsvomc exa vocet ta PN Fon Ear ERR Ex SEES REXV UC 33 3 2 Internal Bate Vienes cincel 34 E AU rela yC Nare ba co PEREDA O O n ica nutu ri r 34 3 2 2 Internal Battery Charge Level Indicator 35 3 9 OXY g n SUDDIV rte 35 Den Pressure SUP alte 35 5 9 2 LOW Pressure Oxy Cen Supply ers a E 36 34 Patient IDG UNE fm m 37 oA Patient Circuit Connect etae te c eo EH ee ta 39 A ace pe ee aa ape ce ee eee eee edencesnareece ere 40 OD AXE Inlet e Pr 41 3 5 1 1 Low Pressure Oxygen Adapter and Filter 41 IO CBRN TF OE tiatotu N 41 54 9 Datena Foi ooo ed 41 3 6 Ventilator CONTO c 44 3 6 1 Rotational Control Knob Encoder sess 44
43. 3 Perform a full calibration as outlined in Section 5 4 Run the Ventilator Verification Test VVT as outlined in Section 6 2 Perform the Functional Verification Tests as in Section 6 3 5 3 Storage When storing the ventilator for three days or more disconnect the oxygen supply When the ventilator is stored for a prolonged period of time the internal battery should be recharged at a minimum interval of every 90 days 5 4 Calibration Procedure The Calibration procedure will perform a full calibration of the Vent201 by adjusting sensor outputs to match quantitative measurements 78 VersaMed Vent201 Service Manual 5 4 1 Purpose The purpose of this procedure is to provide proper calibration of the Vent201 ventilator 5 4 2 Scope This procedure applies to Vent201 Version 1 4 ventilators manufactured by VersaMed and loaded with software version 19 01 or higher This procedure should be performed after any repair software upgrade or significant environmental changes e g elevation Additionally this procedure should be performed annually or any time that the unit fails the Ventilator Verification Test VVT 5 4 3 Tools amp Equipment Certified manometer pressure gauge with 22mm female adapter 0 120 cmH20 Versamed P N 920C0002 01 Certified volume syringe 500ml Versamed P N 920C0001 01 Test lung 2L Versamed P N 910V0005 01 5 4 4 Initialization 1 Froma power off state connect the ventila
44. 6 3 5 3 1 High Pressure Alarm 1 Enter the Alarm Settings window from the Main Menu and highlight the Pressure group Reset the high pressure alarm so that it is at least 5 cmH5O below the average PIP value approximately 30 cmH20 Click on the Accept button 2 Verify that a red pop up Warnings window appears stating High pressure 3 Return to the Alarm setting window and reset the high pressure alarm to 60 cmH O Total Warnings High pressure ME i Tris pee mH High press No EXT MM o2 se 2004 Figure 6 17 High Pressure Alarm 6 3 5 3 2 Apnea Alarm The following test requires simulating patient triggers by quickly squeezing and releasing the test lung in between breaths while the flow is zero 102 VersaMed Vent201 Service Manual 5 6 1 Set the rate to 2 bpm After approximately 20 to 25 seconds verify that a A red pop up Warnings window appears stating Apnea b The mode field changes to a blinking APNEA c The ventilator starts cycling at a higher rate Press clear on the keypad to remove the pop up window then select the blinking APNEA and answer Yes to restore the previous mode APNEA Warnings Restore previous mode and ventilation params EZE Figure 6 18 Apnea Alarm After another 20 to 25 seconds the unit will go back into APNEA alarm Simulate patient triggers and Verify that a During the first minute the unit does not resp
45. Air Inlet gt INLET AIR FILTER DO NOT OBSTRUCT Cooling Fan Vent COOLING FAN DO NOT OBSTRUCT Connector DC Fuse Er Device ID S N IV1813 Device Product Model i Ventoo IC 24 VersaMed Vent201 Service Manual Ethernet Connector not on all units External Display OR Connector EXT SCREEN High Pressure Oxygen Inlet OXYGEN INLET 40 60 psi 2 8 4 2 bar Use 50 psi 3 5 bar DISCONNECT WHEN NOT IN USE K S KEYBOARD onnector Power Pack Fuse T15A 250V ON J L OFF l Power Switch Remote Alarm Connector REMOTE ALARM Serial Communication Connector Issued 15 Aug 05 25 Power Pack Product inside POWER PACK P N 503A0012 Caution This Power Pack contains a sealed Lead Acid Battery Disposal ofthis unit should be according to Environmental Safety Requirements for Lead A cid batteries Pulse Oximetry Probe connector optional not on all units VersaMed VersaMed Medical Systems Inc CAUTION US Federal Law restricts this device to sale by or on the order of a physician WARNING Before use read Operator s Manual thoroughly Before each use check equipment for proper operation To be used by qualified medical or rescue personnel only Versamed Medical Systems Inc 2 Blue Hill Plaza E C 0473 C Pearl River NY 10965 US USA 26 VersaMed Vent201 Service Manual Section 2 System Specifications 2 1 Specification
46. Assemble the ventilator enclosure as outlined in Section 7 4 3 3 page 117 Perform steps 6 12 only if the LCD cable was not detached 8 Remove the power pack assembly replace the battery and reinitialize the gas gauge as outlined in Sections 7 4 9 through 7 5 If the entire power pack assembly is to be replaced perform steps 1 2 only 9 Perform all 500 hours PM steps 10 Perform a full calibration as outlined in Section 5 4 11 Run the Ventilator Verification Test VVT as outlined in Section 6 2 Issued 15 Aug 05 Z4 12 Perform the Functional Verification Tests as outlined in Section 6 3 5 2 4 15000 Hour PM The 15000 Hour PM requires that the entire pneumatic unit be replaced This process will replace virtually all moving parts of the ventilator The following steps should be carried out every 15000 hours 1 Disassemble the ventilator enclosure as outlined in Section 7 4 3 Enclosure Disassembly page 114 Remove the electronic module as outlined in Section 7 4 4 Remove the pneumatic unit as outlined in Section 7 4 5 Install the new pneumatic unit as outlined in Section 7 4 5 3 CAUTION Remember to position the O microswitch actuation cam to a middle position The new O sensor may be packaged in a sealed can along with the pneumatic unit 4 Install the electronic module as outlined in Section 7 4 4 3 Assemble the front enclosure to the rear enclosure as outlined in Section 7 4 3
47. At the 70 kg default settings the baseline for the tidal volume occurs at the 5 cmH2O PEEP value After injecting another 700 ml into the test lung an additional 29 cmH2O is generated above the starting PEEP value The result is a PIP peak inspiratory pressure of 34 cmH5O To summarize if the ventilator generates a PIP of approximately 34 at the 70 kg default settings with a VersaMed test lung the inhale accuracy has been verified The test lung compliance measurement can be viewed by selecting Show Mechanics from the main menu To return to the standard display select Show Graphs 8 3 2 Exhale VT Accuracy Interferences We will assume that the ventilator has been propertly calibrated and verified by the VVT the accuracy of the inhale volume measurement has been evaluated the patient circuit has been substituted and yet you continue to observe a difference of greater than 1076 between the set tidal volume and the exhale measurements This section will discuss known interferences that can cause inaccurate exhale tidal volume measurements 8 3 3 Leakage If the test lung that you are using has a leak the exhale volume will be smaller than the inhale volume Moreover if you set up the ventilator as described in Section 8 5 the flow graph will show a positive offset 158 VersaMed Vent201 Service Manual 8 3 4 Velocity Any test load that can cause a high velocity exhale may create an artificially low exhale tidal v
48. BOUE E APRA o o acad cid M uM CI M IE I IEEE 44 9 0 9 LED IndteatOfS ia 45 3 7 Ventilator Opera 45 Section 4 Theory of Operation 46 4 T1Pmunatuc Uni o si 46 LIT blower Assembly TUTDING itenim o one Deere eiit a 49 412 Oxysemblendthag SY SLC sae ipotesi epap etus otia i epa collie 49 AZ O Pressure ic la 50 41 22 Demand Valve dino dn 50 41 25 l rOportioDiie Valy8 naci 50 4 124 Valve Controlled 51 4 1 2 5 Valve Limit Switch O Microswitch ooooncccccoccnoccconaccnnnccnnnnnnnos 51 Ae 2 6 O KY CCM SersOE mudan ipianda 92 ALS SO lendla Valve Systems diia latas 53 AA Filters and Mirer estera fuse pre bton netus Rte aes nr bct tme 54 n Mss A UE 54 ci e nessuna pret cre errr ert o4 A161 Wye and Flow Senso nsisians iia 54 4 1 6 2 Exhalation Val Vr lesbi 55 AEO 9 B6 Way Vale easet Onn rer eer tere vera mene meer err re 55 4 2 Electronic MOGU ua 56 A ado deni dubai cod Cement Tener du diu aT i ners 59 AZ Nel OY Ste Wl eno 59 AA DIOD A 59 42 Lo DION CUP ae 59 DN a ia eee Um DM EM EM ian ae at 60 42 T5 VGA DISPIAV cac oom Dai dale etd I et aut 60 2 SPA EOR VDOT MN On O See ern enn tre enne enn eet nero 61 EET ch gs duisi PO Cae ree ee pert eer eer ear ere ree eee eer eet 61 42 Wise POC V Evel gol e uos ated ener Ren reer em met eaten 61 1219 Deva rie oy Steni Onee e N 61 22 NAMIE Boar opos ec unitaire mud unn aM e M 61 2 2 1 Sensors ter aCe cosciente mE a E Uer ttp es 62 122 T VOW SE
49. Inside View 1 sees 116 Figure 7 8 Rear Enclosure Inside View f 1 sees 117 Fieure 7 9 Enclosute Reat View Hi te e M edo Uds den pel pede 120 Figure 7 10 Rear Enclosure Inside View 2 seen 120 Figure 7 11 Rear Enclosure Inside View 3 eese 123 Figure 7 12 O2 Mixer Cam to Mid Point Position eere 124 Fioure 7 13 PU Ground Point Locator a 125 I1sure7 HE Front Enclosure Inside View PD vi e t e n edt estere 127 Figure 7 15 Front Enclosure Inside View 3 eene 129 Figure 7 16 BM Cover Screw Loca lo Suscriba 132 Figure 17 Power Fack Rear View calloso 133 Pipure 519 Power Pack Removed uestes usto linderos Oise aee d 134 Figure 8 1 Power Switch Assembly eene 144 Figure o 2 O0 Inlet Pipe and Demand Valve 146 Figure 8 3 PU Main Connector Front View Pressure Switch Pinout 147 Eigureod Oo Mixer TOP View utentes tdt ditas isa utei aca ane ullos Gehe 148 Figure 8 5 Main Connector Front View Microswitch Pinout 149 Heare 0 07 Dneumatie Sensors Connec Hons mbr an 150 Figure 8 7 Test Setup Unit Operating Disassembled sss 156 Figure 8 8 Flow Graphs Occluding the Negative Flow Sensor Port 156 Figure 8 9 Flow Graphs Occluding the Positive Flow S
50. K MO LEE 33 SW TEC seur doc 67 power pack 25 26 46 72 75 77 133 134 135 140 disassembly and assembly 133 36 power supply 28 56 71 power SWIC s oir edes i eit tus 25 69 TODO ooi ON Son dL 144 troubleshooting 143 pressure SensOEs ini occu ieted 62 63 pressure switch i e M M aves 91 troubleshooting 146 172 Programmable Logic Device PLD 64 65 proportioning valve 49 50 Pulse Oximetry Probe connector 26 relief valves repair See Vent201 disassembly and assembly REI TOE O IN 67 71 REL filter block 68 safety2 18 20 21 22 23 33 43 50 52 53 61 75 91 112 151 screen icons DOWBL pem f MAUS 33 serial POT asd quu ta et nee 25 60 software upgrading enana 106 9 Versio A eee 79 88 90 solenoid 46 53 62 91 141 151 solenoids eee 53 65 67 status DIOCK entes adeste 70 Step peT sisi adi 62 65 stepper motor 51 123 142 148 switching block 68 switching board 56 67 143 temperature sensor 62 test lung 79 98 101 136 158 160 test procedures aco itn exta S UM 88 transducer O daft 91 troubleshooting AS eee a a 138 turbine 46 49 142 143 VersaMed Vent20o1 Service Manual valvesotbut
51. LPOUWetOowIEtc O eu uir EU M E MER LI 143 9 2 2 Demand Lo NER 145 0 2 9 Pressure SWIC 146 8 2 4 Valve Limit Switch Oz Microswitch oocoooccconccnonccononononccnnnnanancnnnness 147 8 2 5 Flow Sensor Leak cccccsccccssccccccccccccccccccaccccaccccusccucccescsceccecacsceusess 149 8 2 5 1 Root Cause Pneumatic vs Electronic 151 8 2 5 2 Isolation of Internal Tube Leak eeeesseeess 151 8 2 5 3 Blower Pressure amp Exhalation Valve Control 152 8 2 5 4 Negative Flow Port vs Positive Flow Port 153 8 2 5 5 Negative Flow Port amp Patient Pressure 153 95 2 5 6 P osi ve T Blow POEU suu ue a 157 5 9 Exhiale VT ACCURACY Vai 157 Sod Inhale V T ACCU ati ei CO E nes tbe 158 8 3 2 Exhale VT Accuracy Interferences eene 158 o DY cis da 158 xot Rr ae TC cS 159 8 3 5 MAQUET Siemens 190 Test lung eene 160 8 4 Miscellaneous ISSUES eeeeeeeeeerreeenreeeenrnn 161 AAN sn 161 8 4 2 Fails Calibrate Flow Sensor eese 161 O49 Erratic Controla 161 8 4 4 Erratic Exhale Tidal Volumes esee 162 8 4 5 Low Pressure During Calibration or VVT esses 162 8 5 Setting Up the Ventilator for Static Pressure
52. Maintenance Table 5 2 summarizes preventive maintenance intervals and procedures Table 5 2 Preventive Maintenance Schedule Every 500 hours or 1 Air inlet Filter Replace the air inlet filter Month BENE 1 20 Ventilator Outlet Port Replace the Outlet Port muffler muffler Cooling Inlet Filter Replace the cooling inlet filter Internal Battery Replace internal battery and reinitialize the gas gage e MEME full calibration Ere VVT Perform functional tests Perform safety checks Every 15000 hours Replace pneumatic unit CAUTION Remember that the 1500 annual and 15000 hour PM steps also include most of the other PM steps Perform periodic electrical safety checks as mandated by your facility s internal policies as well as local and national regulations Issued 15 Aug 05 75 5 2 1 500 Hour PM The following steps should be carried out every 500 hours or monthly 1 Remove the used air inlet filter by turning it counter clockwise Ensure that existing o ring remains on the side inlet port 2 Install the new air inlet filter onto the side inlet port CAUTION Take care not to over torque the filter when installing CAUTION Do not attempt to clean and or reuse the air inlet filter Perform the O calibration Run the Ventilator Verification Test VVT as outlined in Section 6 2 page 90 5 2 2 1500 Hour PM The following steps should be carried out every 1500 hours or every 3 months
53. NSE lala 62 4 2 2 1 2 Pressure SerisoES is oii er REED ode A di 63 AA OXY eM OC O A A 63 422 T Tem perature OCASO ara 63 AZ to DOtter VO AO Bo tetas Seely E at ca idest uu ec nest 63 412221 italy Analog Interface natillas 63 4225 Controland Status aaa 64 t22 E MOr TAE AC E esit dto oae d etu adt 64 ADD ONDAS HWER ICE tato 64 412 206 0lenolds IM aaa 65 4227 7 DLC Per nie acusa dd Rd n ME 65 4 228 Watchdog TIME esiaren aE ER dest espe Ea 65 BD IREME ATIT o OO AT T ET 65 ADD PO a 66 42 9 Zeromep Purse DOGEG oae eased aca ame i Hb den Do epi cin aat pee dicus 66 24 5witchitie DOAPQo utes o eU id peat iut hts i eee tees 67 ADA NSW MIS Docena pantalon 68 1242 SM lh BIO A Ne o eee re 68 425 Protective DeVICOS is a 68 4244 Battery Charser Block cercado ooo 69 4 2 4 5 5V Output DC DC Converter esee 69 42 16 Power Ons Off SWIGCDIDS iiem ad 69 qos ortus DIOC ae vett enm eda tenia Ue rdi 70 A us e Nr c m 70 4 2 4 9 External DC DC Converter and External DC Source 70 AZA TO Amalia Power 50 pp Hes untar o eet dent 70 4125 Power supply XC DE Converter quede tbt tee ettet eodd 71 Prats NM rero hig E ha eee c 71 4 9 CCD DISHIAY test 71 4 4 Interface Board init 72 A Di OW GI eG dud E TN 12 BON Gas Gauge EE O ep MONI UL Un b Suet Put Es 72 Section 5 Maintenance and Calibration 74 5 1 1 Cleaning and Routine Maintenance eene 74 5 2 Preventive Maintenance
54. Notice Alarm will sound when the ventilator is powered up Clear the pop up window and ignore the alarm Alternately yu may remove the O Sensor from the pneumatic unit and plug it into the connector coming from the electronic module Use a 1 stopper to plug off the hole vacated by the sensor 6 Temporarily disconnect the two check valves from the purge pumps 7 Adjust the range setting on the flow graph to 210 lpm Use hemostats or needle nosed pliers to slowly occlude the diameter of the suspect sensor tube 9 Observe the flow graph and determine if the flow rate holds or rises If any alarm pop up window appears press the front panel silence button and continue to observe the flow graph Normally when there is no leak present if you occlude the negative port sensing tube the flow graph trace will go in a negative direction or hug close to the baseline depending upon how fast the tube is occluded Even if the unit is trying to ventilate the flow graph trace will spend most of its duration in the negative region see Figure 8 8 page 156 If there is a leak in front of the occlusion the flow graph will go positive or spend most of its duration in the positive range see Figure 8 8 Keep in mind that the patient pressure tube transducer and check valve purge pump are branches off of the main line which ultimately dead end and are leak tight Each branch is connected by a Y adapter When the patient pressure bra
55. Raise O supply Pr Switch on pressure is less pressure so that it 100 than 40 psi is 40 psi or greater during the entire test O supply press is O Pressure Replace O 511A0126 or 40 psi and above Switch is out of Pressure Switch 504A0206 at all times acceptable range Service Notice Error Code 359 in Mixer was Manually turn Alarm after technical log started in stepper motor power up extreme 21 counter clockwise position until microswitch cam is in mid position technical log calibration system sensor and recalibrate Error Codes 330 Main Pneumatic Reconnect Main Pneumatic Harness in technical log disconnected from Pneumatic Unit O2 is higher than Leakage at 333 345 347 359 connector Reinstall Demand Valve fittings Fails VVT Demand Valve Leak Demand Valve setting only when outlet silicone closer to O inlet high pressure O connection pipe is supplied Demand Valve is Replace Demand 318C0002 entraining O Valve O2 is higher than O2 system is out Calibrate O2 21 at 21 of calibrationat system setting when high 21 pressure O is not supplied Need Cal alarm Error Code 306 in O2 system out of Calibrate O2 after power up technical log calibration system 21 at 21 Fails VVT Flow Zeroing Purge Plug Zeroing Zeroing right Board Purge Board into after Flow disconnected Main Board and check retainment
56. Reroute tubing and recheck Ventilator settings were not optimized for the particular patient or connecting interface Replace Patient Circuit Remove fluid with appropriate syringe and hypodermic Install one way valve or replace Patient Circuit Replace Patient Circuit 620B0006 620B0006 620B0006 The following sections expand on the troubleshooting guide and describe failures requiring more extensive diagnosis and repair 8 2 1 Power Switch The power switch connects to the Switching Board via a 3 pin white connector located at J8 When the unit is powered off there is continuity Issued 15 Aug 05 143 between the black and yellow wires When the unit is powered up there is continuity between the black and red wires Historically virtually all power switch problems are mechanical in nature and confined to the actuating and hold mechanism of the alternate action If a unit will power up only as long as you hold the power switch button in then check for the following 1 Usea needlenose or slip joint pliers to pull the power switch button cap straight out from the back of the unit 2 Visually check that there is no gray ring gasket present If the gasket is present then remove it 3 Reinstall the button by lining up the slot on the hollow shaft of the button with the white dot on the recessed collar and pressing straight in 4 Verify the alternating action of the power switch Normally
57. Service Manual Part No SM 01 04 Rev 4 Revised August 2005 CE 0473 2005 VersaMed All Rights Reserved No part of this document may be photocopied reproduced stored in a retrieval system or transmitted in any form or by any means electronic mechanical or otherwise without the prior written permission of VersaMed No warranty of accuracy is given concerning the contents of the information contained in this publication To the extent permitted by law no liability including liability to any person by reason of negligence will be accepted by VersaMed its subsidiaries or employees for any direct or indirect loss or damage caused by omissions from or inaccuracies in this document VersaMed reserves the right to change details in this publication without notice Adaptive Flow and Adaptive Time are registered trademarks of VersaMed SAFETY Before attempting to service or test the Vent o ventilator please read this manual and the Operator s Manual in their entirety to familiarize yourself with all Cautions and Warnings Manufacturer s Address VersaMed Medical Systems Inc 2 Blue Hill Plaza Bldg 2 Pearl River NY 10965 845 770 2840 Authorized Representative in the European Community Obelis S A Avenue de Tervuren 34 Bte 44 B 1040 Brussels Belgium 32 2 732 59 54 Fax 32 2 732 60 03 Calling For Help If you have a ventilator problem that you cannot solve and you purchased your ventilator
58. acing up and place it on the right side of the ventilator enclosure see Figure 8 7 page 156 Position the front enclosure in front of the ventilator enclosure and electronic unit and connect the following a Connect the main connector from the electronic module to the pneumatic unit b Connect the power pack connector from the rear enclosure to the electronic module c Connect the ribbon cable from the electronic module to the front enclosure s interface board d Connect the LCD cable from the electronic module to the front enclosure e Connect the inverter cable from the front enclosure to the electronic module f Connect the tube with the blue stripe to the leftmost fitting when viewed from the front g Connect the tube from the Y adapter to the right fitting on the left side h Connect the remaining tube to the barbed port on top of the ventilator outlet and the right most front panel fitting Try to connect the sensor tubing to alternate external luer fittings if possible see Figure 8 7 page 156 If no external fittings are available connect the flow sensor tubes as outlined in steps f and g and connect the blower sensor tube to the barbed port of the ventilator outlet and then insert the remaining tube over the male luer nipple of the patient circuit exhalation valve control line 154 VersaMed Vent2o1 Service Manual Since the O sensor is not connected to the electronic module a Service
59. age update 112 13 OVC Ac QM NNNM 20 overview of electronics 58 PEEP RPM calibration 79 A A A es 33 software application 60 specifications 27 28 environmental specifications 29 Standards A IA 29 ME C EHE 21 23 29 OO A 29 A EEEE AE 29 test procedures See test procedures Warran a 2 keyboard external 25 59 61 LCD display urna 46 60 71 140 removal and installation 126 troubleshooting 71 161 leak 55 91 125 141 145 158 162 CUP noS oers 149 57 flow sensor enn 149 or EM 60 138 downloading 109 11 luer connection 39 55 89 97 149 152 153 154 main board 56 61 66 67 142 See also microswitch actuation cam 51 78 motor 49 54 62 64 65 67 68 70 Speed tes taa em DON 91 ds A gehen ee 91 Multa da 46 142 O 21 30 31 32 37 44 49 50 51 52 62 74 75 76 78 79 80 85 86 90 91 94 95 98 99 100 101 103 119 120 12T 122 125 124 125 155 142 145 145 146 147 146 155 161 162 calibra HOM 76 erratic control 161 O microswitch See valve limit switch O pressure switch 49 50 142 O sensor 51 98 121 135 155 maintenance 74 135 Oo BIO A CIN 51 Operation
60. al Verification Test 40 88 90 138 o tleb pont 54 135 OVT See Operational Verification Test oxygen 22 25 26 27 28 35 36 37 41 44 49 50 51 52 63 78 165 See also Or COMME CEN atada dada 35 low pressure supply 36 E a A E ied 35 36 oxygen blending system 46 49 oxygen concentrator 36 OXygen sensor 49 52 62 63 replacement esse 52 patient circuit 31 37 38 39 40 46 54 85 88 89 141 143 computer CPU board CANS M 88 90 manometer 2 aa 79 82 93 COMMECCTION iaa 39 Metered Dose Inhaler MDI 39 CODLEOL Be scita neos 54 Issued 15 Aug 05 171 OW SENS OP aliadas 54 one way valve 55 88 SEIS e DM E MN 39 40 PC Watchdog see under computer 59 PEEP 32 37 53 55 79 83 84 158 163 pneumatic resistor 79 81 98 101 136 pneumatic system 46 62 149 pneumatic unit 46 47 48 74 121 123 141 142 143 149 maintenance 74 75 78 removal and installation121 26 121 power 45 See also power pack Arias 21 23 24 28 33 34 AC input connector 71 AC DC CONV CITED a c ci tiro 71 CHEN sata 68 CODVOESIO ri 67 DC 21 23 24 28 32 33 34 69 70 external 33 68 70 O soc d ico 67 A A UE LER ISOE 24 68 SOC
61. be 500 10 Repeat this calibration step if the values are not satisfactory 5 Disconnect the calibration syringe from the patient circuit E 20 an SIN Vete s Calibration lo Connect a half litre syringe to the patient circuit Press 1 Y l pr mm a i Start and pump the syringe 10 times slowly and steadily Count Inhale volume Exhale volume E Start Cancel i Wo EXT EE uris MENU Figure 5 8 Calibrate Volume 5 4 5 7 O2 System 1 From the Calibration window select the Calibrate O2 System option and press Start 2 Waituntil the calibration is finished for about 100 seconds The message Working flashes on the screen during the calibration step 3 Press Close to return to the Calibration window Issued 15 Aug 05 85 ig Figure 5 9 Calibrate O2 System 5 4 5 8 Save New Calibration 1 From the Calibration window press Close 2 Press YES to save the new calibration factors or NO to discard the calibration and retain the previous values CAUTION VVT should always be performed after calibration 86 VersaMed Vent201 Service Manual Lh e Save Calibrations us MESS _MENU Figure 5 10 Save Calibration Issued 15 Aug 05 67 Section 6 Ventilator Test Procedures 6 1 Operational Verification Test The Operational Verification Test O V T is an automated test designed to check the connections of the breathing circui
62. ble assembly under the interface board and plug it in to the mating connector Issued 15 Aug 05 129 8 Slide the interface board into the vertical tracks with the component side facing the bottom of the front enclosure Verify that the interface board has been inserted all the way and that the sides of the board are flush with the mounting holes 9 Install the 2 3mm x 8mm Phillips head screws and 4mm washers into the mounting holes located on each end of the PC Board While tightening the screws push the washers toward the center so that they hang over the tracks CAUTION Be careful not to over tighten the screws 10 Connect the front keypad 9 pin flex cable assembly to the mating connector of the interface board 11 Connect the green ground cable s to the tab s on the interface board 12 Identify the interface board type and follow the corresponding steps a Front enclosure has a speaker i Connect the blue 6 pin encoder connector and white 2 pin speaker connector to the mating connector of the interface board b Front enclosure has no speaker i Install the encoder into the mounting hole and radially orient it so that the ribbon cable is closest to the bottom Be sure that it is seated within the raised rectangular area ii Use the 11mm nut driver to install the nut and tooth washer onto the mounting threads of the encoder ili Radially orient the rotational control knob so that the indent of the k
63. bly Removal 1 Disassemble the front enclosure from the rear enclosure as outlined in Section 7 4 3 2 Enclosure Disassembly page 114 Remove the 1 3mm x 18mm Phillips head screw lock washer and washer from the LCD shield located at the inverter cable ground junction corner see Figure 7 14 Remove the remaining 2 3mm x 14mm Phillips head screws and lock washers from the LCD shield Disconnect the backlight connector from the inverter board see Figure 7 14 Lift out the LCD shield and screen as one unit Remove the 4 2mm x 8mm Phillips flathead screws from the corners of the black LCD mask and lift it out Lift out the clear LCD protection window and inverter carrier 126 VersaMed Vent2o1 Service Manual LCD Shield Backlight Connector Inverter Board Ground Point Inverter Cable wv isW 2 7 4 6 3 LCD Assembly Installation 1 Place the LCD protection window and inverter carrier into the top inside of the front enclosure The assembly is keyed so there is only one valid position 2 Place the black LCD mask on top of the LCD protection window so that the cutout is to the right and the lip is facing out 3 Install the 4 2mm x 8mm Phillips flathead screws into the corners of the black LCD mask Now is the best time to dust and clean the inside of the protection window and the LCD screen A glass cleaner works well for this purpose 4 Place the LCD shield and screen on to
64. e power pack assembly and lift off the cover Turn the battery pack assembly upside down and slide the battery out of the casing Using the pliers remove the two spade connectors from the exposed battery terminals Figure 7 17 Power Pack Rear View Issued 15 Aug 05 133 Figure 7 18 Power Pack Removed 7 4 9 3 Power Pack Assembly 1 Connect the red wire to the positive terminal of the battery and the black wire to the negative terminal CAUTION Reversing the polarity of the wires will destroy the battery gas gauge located within the power pack 2 Slide the battery into the casing Be sure that the red and black wires are located towards the recessed part of the battery cavity 3 Position the cover into the casing and fasten the 5 3mm x 10mm Phillips head screws and lock washers to the back of the power pack housing 4 Slide the assembled power pack into the ventilator compartment until the cover is flush with the back of the unit Power up the unit briefly and verify that the connection was successful by listening for the cooling fan operation 5 Install the 4 3mm x 20mm Phillips head screws into the corners of the power pack assembly 134 VersaMed Vent201 Service Manual 7 4 10 O Sensor Removal and Installation 7 4 10 1 Tools amp Equipment e Screwdriver Phillips 1 e Hex Key 3mm 9 inch length 7 4 10 2 O Sensor Removal 1 Disassemble the ventilator enclosure as o
65. e window will appear Select the Ventilator Verification option and the Ventilator Verification window appears Issued 15 Aug 05 91 SIMU Uctrl A Exhale eru nu d 0 SC Main Mew Ratecse 12 Un Alarm Settings Advanced Settings el QU Restore Defaults Graphs Patient W er Caution Loops Mechanics STANDBY Sees mer Display L m i Set parameters and press O U T Hae LL ELISELE HE REL LL SULL emt Offon Offi lo EI Of fen Offi Al A 8 8 M Uol 8 8 03 18 2004 C wg rxr E MENU Figure 6 3 Entering the Maintenance Window S ve Exnaie so ern n E itrl a sn Exhale Maintenance 27 SIMU Uctrl sao ume Calibration Screen Ever lator Uerification Ventilator Verification 5 rai start the WT process i er Configuration Screen Bx 48 Seruice Screen E Technical Log Book Commun ication Rate 38400 a Local ization 20 Total Operating Hours 320 Se Note Press Start to begin Clone Cancel TEAT ers CM j O No EXT E 0046 2000 MENU v No EXT Dam us L4 MENU Maintenance Window Ventilator Verification Figure 6 4 Entering VVT 4 PressStart and the VVT Confirmation window will appear asking if the first alarm tone is audible The volume of the first alarm is adjustable i
66. ear stating that only trained service personnel should enter the restricted Maintenance area Select Yes and the Maintenance window appears Select the SERVICE SCREEN option Select the UPDATE PACKAGE KEY option The new window will display the old key code The characters are presented in groups of four separated by hyphens and are limited to hexadecimal format 0 9 A F It may not be necessary to re enter all 16 characters Typically less than half of the characters will need to be changed and quite possibly only one may require changing 112 VersaMed Vent201 Service Manual 6 Using the rotational control knob highlight and select the first character of the package key that needs to be changed 10 11 12 15 14 15 16 17 Figure 7 5 Update Package Key Scroll through the values until the desired character appears and press in the control knob Repeat steps 7 and 8 until all the relevant characters have been changed Highlight and press OK A system message appears stating The package was successfully installed Restart the iVent for update Highlight and press OK Power off the ventilator and then power it up again for the changes to take effect Select the 70 kg patient weight in the opening screen From the Main Menu select the Maintenance option A Caution window will appear stating that only trained service personnel should enter the restrict
67. ed Maintenance area Select Yes and the Maintenance window appears Select the CONFIGURATION option View the Package to ensure that it has been changed to the desired option level Press clear twice to return to the Standby screen Issued 15 Aug 05 113 7 4 Ventilator Disassembly and Assembly Full or partial disassembly and reassembly of the ventilator will be required for PM component replacement or diagnostics and repair The following subsections are organized by sequential stages of disassembly and reassembly For instance if you go through all of the disassembly procedures in the order presented the entire ventilator will have been disassembled down to any replaceable component If you go through all of the reassembly procedures in the reverse order the entire unit will have been rebuilt from basic components and modules 7 4 1 Purpose The purpose of this procedure is to provide clear instruction for the disassembly and reassembly of the Vent201 ventilator 7 4 2 Scope This procedure applies to Vent201 Version 1 4 ventilators manufactured by VersaMed Medical Systems Inc 7 4 3 Enclosure Disassembly amp Assembly 7 4 3 1 Tools amp Equipment e Screwdriver Phillips 1 e Hex Key 3mm 9 inch length e Pliers needle nosed e Nutdriver 7mm 7 4 3 2 Enclosure Disassembly 1 Place the ventilator face down on an appropriate protective surface The foam inserts from the original Vent201 ship
68. en the inspiratory limb of the patient circuit and the ventilator outlet 3 5 Filters The Vent utilizes the following filters see Figure 3 6 e A protective filter at the ventilator air inlet e Auser supplied bacterial filter at the ventilator outlet e Auser supplied filter or HME filter at the patient circuit outlet 40 VersaMed Vent2o1 Service Manual 3 5 1 Air Inlet Filter The Vent is shipped with the protective air inlet filter in place This filter should be replaced every 500 hours or monthly There are two other types of filters that may be used at this location e A low pressure oxygen filter adapter supplied by VersaMed e AChemical Biological Radiological Nuclear Filter 3 5 1 1 Low Pressure Oxygen Adapter and Filter This filter is used with the low pressure oxygen supply system outlined in Section 3 3 2 It has the same protective media used in the standard filter but terminates in a 22mm female port CAUTION The low pressure oxygen adapter should not be used when entraining ambient air Unlike the standard air inlet filter the 22mm port of the low pressure oxygen adapter could be inadvertently blocked 3 5 1 2 CBRN Filter In the event of environmental contamination by hazardous or toxic compounds the air inlet filter may be removed and replaced with a CBRN Chemical Biological Radiological Nuclear filter P N 620B0012 01 or another active carbon filtration device using a VersaMed su
69. ensor Port 157 Figure 8 10 Flow Graphs High Velocity Exhale esses 160 Figure 8 11 Test Lung 190 and Vent Waveforms esee 161 Tables Table 2 1 Displayed Parameters and Indicators During Ventilation 30 Table 3 1 Internal Battery Charge Level Indicator esses 35 Table 5 1 Cleaning and Routine Maintenance eene 74 Table 5 2 Preventive Mamtenance Schedule 75 Table 8 17 Troubleshooting Guide resistiendo dida 139 Section 1 Introduction 1 1 Intended Use This Service Manual describes the service maintenance and test procedures for the 7Ventzo1 hardware version 1 4 It is intended to ensure optimal functional operation and safety of the device This Service Manual should only be used by authorized VersaMed trained technicians This Service Manual must be used in conjunction with the Operator s Manual OM 01 04 and is complementary to it The contents of this document are not binding If any significant difference is found between the product and this document please contact VersaMed for further information VersaMed reserves the right to modify the product without amending this document or advising the user IMPORTANT Technical information is supplied in this manual that is intended to facilitate a complete understanding of the ventilator s structure and function Not e
70. entilator via a three pin XLR male connector with an input for the direct 12V to 15V source or for an external DC DC converter and a common ground Both sources have a user accessible fuse on the back panel 4 2 4 10 Auxiliary Power Supplies In addition to the 12V and 5V power supplies auxiliary power supplies are provided for the analog section and for an optional LCD power supply A precisely regulated quiet 5V analog supply powers most of the analog circuits except for a separate adjustable quiet supply for the pressure sensors A negative analog supply is also provided for the input instrumentation amplifiers in the flow sensor path VersaMed Vent2o1 Service Manual In addition a digitally controlled voltage source exists for LCD displays which require a voltage of up to 27V Assembly wiring determines negative or positive voltages 4 2 5 Power Supply AC DC Converter The ventilator has an internal AC DC converter which accepts universal AC voltages from 85 to 265V 40 440Hz and outputs a 14 2VDC voltage The AC input connector also includes a RFI filter and dual 3 15A slow blow fuses The DC output of the converter goes directly to the switching board 4 2 5 1 Cooling Fan The cooling fan is mounted inside the electronic module and exhausts all of the heat generated inside the entire ventilator Air is entrained through the filtered inlet located at the front of the unit and then through the vented slots located at the
71. eps for the following e O System test e 100 O Suction test e Safety Alarms test 6 3 5 1 O Delivery and Linearity Adjust the external O2 analyzer calibration so that it reads 21 Connect the O2 supply to the ventilator Wait for 20 breaths and verify that the external O2 analyzer measurement is equal to the FiO setting of the ventilator 10 FiO2 Issued 15 Aug 05 99 By selecting Alarm Settings from the Main Menu you can view the O value that the ventilator is currently measuring This number is in blue and located to the left of the min max alarm bar Note If no cursor movement is sensed by the ventilator for one 1 minute it will timeout and return to the Main Menu Internal Os Measurement Figure 6 15 Internal O2 Measurement Set the FiO to 6076 and repeat step 3 Set the FIO to 100 and repeat step 3 From the Main Menu select Restore Defaults A Warning window will appear stating that this operation will change the mode and all of the current parameters Select Confirm and then select 40 kg Repeat steps 3 through 5 From the Main Menu select Restore Defaults A Warning window will appear stating that this operation will change the mode and all of the current parameters Select Confirm select 70 kg and set the pressure limit to 60 cmH20 6 3 5 2 100 O Suction Test 1 Press the 100 O button on the ventilator front panel keypad Verify that a green pop up window a
72. er Pack RS 232 Comnector Power Pack Handle AC Power Cord Figure 1 2 The jVent o rear view 1 3 Safety Information In accord with the important information herein always comply with applicable national and local safety regulations Responsibility for the safe function of this equipment reverts to the owner or user in all cases where an unauthorized person performs service or repair and when the equipment is not used for its intended purpose 20 VersaMed Vent201 Service Manual 1 3 1 Safety Regulations The following medical electrical equipment safety standards have been met IEC 60601 1 1 Medical Electrical Equipment Part 1 General requirements for safety 1 Collateral standard Safety requirements for medical electrical systems IEC 60601 1 2 Medical Electrical Equipment Part 1 General requirements for safety 2 Collateral standard Electromagnetic Compatibility EMC IEC 60601 1 4 Medical Electrical Equipment Part 1 General requirements for safety 4 Collateral standard Programmable Electrical oystems IEC 60601 2 12 Medical Electrical Equipment Part 2 12 Particular requirements for the safety of lung ventilators Critical care ventilators UL 94 HB Flammability 1 3 2 Technician Safety 1 3 2 1 Hazard Notices Before disassembling or assembling the ventilator ensure that e The O gas supply is disconnected e The AC or DC power cords are disconnected e The power switch is set t
73. er the weight of the rear enclosure and assembly the seam around the entire perimeter of the unit should be closed and even If it is not then there is interference from the tubes and or cables that were just connected 13 Install the 2 4mm x 30mm screws and lock washers to the bottom rear of the enclosure 14 Install the 2 4mm x 50mm screws and lock washers to the top rear of the enclosure 15 Attach the roll stand adapter plate to the bottom of the unit by installing the 4 3mm x 8mm Phillips head screws and lock washers Be sure to orient the plate so that the single middle hole is toward the rear of the unit 7 4 4 Electronic Module Removal and Installation 7 4 4 1 Tools amp Equipment e Screwdriver Phillips 2 118 VersaMed Vent201 Service Manual 7 4 4 2 Electronic Module Removal 1 Disassemble the front enclosure from the rear enclosure as outlined in Enclosure Disassembly Section 7 4 3 2 page 114 2 Unscrew the green Oz inlet cap from the DISS fitting on the rear of the unit see Figure 7 9 page 120 3 Remove the 2 3mm x 8mm Phillips head screws from the rear of the enclosure 4 From a point of view facing the inside front of the rear enclosure disconnect the green ground wire from the left side of the electronic module EM see Figure 7 10 page 120 5 Disconnect the blower pressure sensing tube from the top of the outlet port 6 Disconnect the connector from the top of the
74. erage voltage presented to the motor and thus the speed The tachometer output from the motor after level shifting and filtering is used to measure RPM The PLD measures the width of the tachometer pulse and presents this value in the RPM register for use by the software When an unexpected signal is detected the motor can be disabled by either the watchdog or by the software When booting the system an enable sequence is transmitted from the software to the PLD which prevents the motor from running freely before the software is active 4 2 2 5 Bus Interface The PC104 bus mediates all transactions between the CPU board and the main board A Lattice programmable logic device PLD recognizes accesses to the main board and translates them into control signals to the registers All bus transfers are 16 bit transfers Data and address buffers isolate the main board bus from the CPU board bus The bus is implemented as a stack through a connector This allows future VersaMed Vent2o1 Service Manual expansion boards to be stacked above the main board using the same connector 4 2 2 6 Solenoids Interface FET switches drive the solenoids to the 12V supply The system supports two solenoids Writing bits to the Lattice PLD activates the solenoids This either opens the switch continuously to open the valve or presents various PWM levels so that a constant voltage keeps the valves open The appropriate PWM level is determined by the soft
75. g Teflon Tape 548 REF Figure 8 2 O Inlet Pipe and Demand Valve 8 2 3 Pressure Switch There are two 2 versions of this component and connecting inlet pipe It is best to call VersaMed service before attempting replacement This component can be verified for proper operation independently by connecting an ohmmeter to the terminals and measuring the corresponding switch state The switch is normally open no O2 and should close with the presence of high pressure O 146 VersaMed Vent201 Service Manual 1 With the unit powered off disassemble the front enclosure as outlined in Enclosure Disassembly Section 7 4 3 2 page 114 2 Identify the O pressure switch type and connect the ohmmeter to the corresponding connector contacts a For silver colored metal which is threaded directly onto the O inlet pipe e Pins 1 amp 2 red wire amp white wire b For the brass colored switch metal body mounted to the back wall of the rear enclosure e The two tabs located on the rear of the switch body Regardless of the O pressure switch type the switch terminals are connected to pins 9 amp 17 in the PU main connector see Figure 8 3 Figure 8 3 PU Main Connector Front View Pressure Switch Pinout 3 Reassemble the front enclosure to the rear assembly as outlined in Section 7 4 3 3 Enclosure Assembly page 117 8 2 4 Valve Limit Switch O Microswitch The O microswitch is wired for a normally
76. ge over time and correcting the measurement for environmental and operating conditions yields the available battery charge The current battery charge is displayed as a symbol on the LCD A low battery message is activated when the measured battery charge has depleted to a remaining 20 or the battery voltage has depleted to 11 3V An empty battery alarm will activate when the battery voltage depletes to 11 0V When there are a lot of partial discharges such as in transport applications errors will accumulate and the gas gauge must be re educated or allowed it to measure the total battery capacity This procedure is outlined in Section 7 5 page 136 Although the gas gauge will track the amount of battery charge it cannot detect when the battery capacity has deteriorated to an unacceptable value The best method for determining the battery capacity is to run the unit and measure the total run time under typical parameters It is important to distinguish between the low battery message and the empty battery alarm The low battery message issues a warning The run time doesn t end until the empty battery alarm activates Typically 3 12 minutes of operation remain left after this alarm While the battery is automatically checked during VVT to determine if it is severely deteriorated the VVT cannot measure adequate capacity Only functional testing can determine adequate capacity run time Issued 15 Aug 05 73 Section 5 Ma
77. gh speed DC brushless motor with internal commutation The motor speed is adjusted by changing the voltage of the power input The voltage is varied by PWM Pulse Width Modulation control of the motor driver on the switching board The motor sets the impeller in motion with variable speeds which adjusts the pressure and flow parameters Gas is drawn into the blower from a manifold located at the bottom of the blower assembly The blower can reach speeds of 22 000 RPM and generate 80 90 cmH2O max It is powered by the 12VDC supply and draws 4 amps maximum It has a tachometer for monitoring speed and is supervised by a watchdog circuit A braking function is provided which connects the motor terminals together via a low resistance power resistor It is rated for 15 000 hours and must be replaced periodically The blower assembly is carefully balanced inside the pneumatic unit housing by the manufacturer and cannot be serviced in the field Replacement of the blower assembly due to failure or scheduled PM requires the replacement of the entire pneumatic unit assembly This device is automatically checked during the Ventilator Verification Test VVT 4 1 2 Oxygen Blending System The gas delivered to the patient by the ventilator is a mixture of air and pure oxygen The oxygen blending system controls the oxygen concentration of the gas mixture The oxygen blending system consists of the following components e O Pressure Switch e
78. h the rubber stopper or equivalent 13 Press START when ready When the Apnea alarm window appears press Close then select the blinking Apnea message in the mode field and select Yes to the restore previous mode question If the Check Sensor alarm window appears press Close and then Restore Issued 15 Aug 05 163 Appendix A Parts and Accessories Ventilators Part Number Description 50112201 IC Nent201 IC System 50112201 AB Nent201 AB System 50112201 IC AB Nent201 IC AB System 50112201 HC Nent201 HC Home Care System Nent201 Transport EMS System 809A0005 A0 AB Adaptive Bi Level software option for IC Systems only 809A0007 A0 IC ICU software option for AB systems only Accessories Part Number Description 660B0001 12 Disposable Breathing Circuit type box of 12 620B0017 20 Disposable Breathing Circuit Y type box of 20 620B0006 20 Disposable Breathing Circuit Y type box of 20 620B0008 A0 Multi use Patient Breathing Circuit Y type 1 unit Polysulfone Sensor and Silicone Tubing 620B0008 10 Multi use Patient Breathing Circuit Y type box of 10 Polysulfone Sensor and Silicone Tubing 660A0001 12 Air filter inlet box of 12 disposable 660L0001 12 Low Pressure Oxygen Adaptor amp Filter box of 12 disposable 620B0009 01 Valve Assembly Low Pressure Oxygen 620B0010 01 Reservoir Bag 1 Liter Low Pressure Oxygen 164 VersaMed Vent201 Service Manual 630B0003 A0 Oxygen Cylinder Holde
79. he main board e Motor period tachometer from the motor The primary outputs from the switching board are e 12V supply to the system Issued 15 Aug 05 67 e 5V supply to the system e Variable voltage to the motor e Charging current to the battery e Status signals to the main board e Miscellaneous control signals to the main board 4 2 4 1 Switching Block The switching block switches between the three 3 power sources using Schottky power diodes The sources are e AC DC power supply 14 2VDC e External 12V to 15VDC supply e Internal 12V battery All of the external power sources are connected together through signal diodes to indicate that an external source is present CHEN The common node of the power diodes is the board main power bus VSUM The voltage on VSUM may vary depending on which source is present nonetheless this is referred to as the 12V supply 4 2 4 2 RF Filter Block The RFI filter block filters conduct electromagnetic noise on the DC power supplies This provides electromagnetic immunity from external noise inwards and prevents conducted emissions from propagating outwards The filter is an LC filter with a differential stage and a separate common stage Inductors are formed by common windings on a ferrite core and capacitors are provided between the source FIN15V and the return wire FGND and to the chassis ground 4 2 4 3 Protective Devices The system is protected against over current by
80. hen an external power source is not available The battery pack connects to the ventilator by means of an internal connector that contains a charging input a power output a communication line to the battery gauge and a common ground A 12V rechargeable sealed lead acid battery with a capacity of 7 2 to 9 0 Ah is used With a fresh fully charged battery 4 8 to 5 6 amp hours are used until the battery voltage reaches 11 0 The ventilator draws approximately 4 amps under typical parameters Therefore the unit should run for 1 2 to 1 4 hours The battery is a perishable component and should be replaced every year CAUTION The power pack contains a sealed lead acid battery Disposal of this component should be in accordance with Environmental Safety Requirements for lead acid batteries 4 5 1 Gas Gauge The battery gauge determines battery capacity by monitoring the amount of charge input to or charge output from the rechargeable battery The gauge measures discharge and charge currents estimates self discharge and monitors the battery for low battery voltage thresholds It compensates for temperature and various charge rates Monitoring the voltage across a small value series sense resistor 72 VersaMed Vent201 Service Manual between the battery s negative terminal and ground makes the charge measurable The battery gauge monitors the charge and discharge current as voltage across a sense resistor Monitoring this volta
81. her 7 1 3 Tools amp Equipment e PC running Windows 95 OS or higher with the new Vent201 software version installed and a free RS 232 port Coml to Coma e 5 222 communication cable DB 9 female female null modem 106 VersaMed Vent201 Service Manual 7 1 4 Procedure 1 Turn on the PC connect the RS 232 port of the PC to the RS 232 port of the ventilator using the null modem serial communication cable 2 Connectthe AC power to the ventilator and switch it on Select the 70 kg patient weight in the opening screen 3 From the Main Menu select the Maintenance option A Caution window will appear stating that only trained service personnel should enter the restricted Maintenance area Select Yes and the Maintenance window will appear Select the SERVICE SCREEN option 6 Select the UPGRADE SOFTWARE VERSION option Figure 7 1 RS 232 Cable to iVentzo Issued 15 Aug 05 107 Figure 7 2 Upgrade Vent201 Software Screen 7 Double click on the file named install exe on the PC or shortcut placed on the desktop to start up the install application 8 Verify that communication is established the message CONNECTED TO COM number should appear at the bottom left of the application window If it does not check the RS 232 connection and cable You may also be required to select the appropriate COM port com1 to com 4 from the Com menu 9 Press CONNECT on the application sc
82. ine e Oxygen Blending System e Solenoid Valve System e Filter and Muffler e Cooling Fan e The Patient Circuit 46 VersaMed Vent2o1 Service Manual O2 Inlet Solenoid Valves Demand Valve O2 Pressure Switch Air Inlet Blower Motor O2 Sensor _ y Main PU Comnector Stepper Motor Fan Outlet Muffler Figure 4 1 Pneumatic Unit The diagram on the following page shows the basic pneumatic components and their relative positions along the flow path It is a good idea to reference this diagram when reading the component descriptions Issued 15 Aug 05 47 JeyI4 Jeuejoeg NOJO juegeg 974 PAR Y v xr E KE JWH HONS MSS x juened XO ft hE eoan j O OO O 9oJnss9Jd JOSUSS MO 9JnssoJd JON Elgin S mold ene ean 19414 eju atv vyjepo be are JOje nuoA eee UL LER ROOD OZHW9 06 0 NdjNO J XIN ZO eutgun 1 je olg HOd 1elU JI V ZO ON ISA QI ZO Sd OL lt YIIMS eJnssaJd ZO OZHWO 09 0 ndino isd OS isd QG jndu Hog je U ZO 9A EBA pueuie J3 01JUO 9 INBA JOSU8S ZO y SOAJEA Jairo 9INSSIIANIAO SOA BA plousjos ssed g Figure 4 2 Pneumatic Unit Overview VersaMed Vent2o1 Service Manual 48 4 1 1 Blower Assembly Turbine The function of the blower assembly is to generate pressure and flow of the gas mixture to be delivered by the ventilator The blower assembly includes a motor impeller blower cover housing and manifold The motor is a hi
83. intenance and Calibration 5 1 1 Cleaning and Routine Maintenance To ensure correct ventilator operation perform the following maintenance procedures at the recommended intervals The cleaning and routine maintenance for the iVentz01 is summarized in Table 5 1 below Table 5 1 Cleaning and Routine Maintenance Ventilator Wipe exterior clean with a Do not allow liquid to penetrate damp cloth and mild into the ventilator detergent Cooling Vents amp Cooling Clean every 1500 hours or3 Use vacuum device to clean the Inlet Filter months of use or as cooling vent outlet and cooling necessary inlet filter Replace cooling inlet filter annually or as necessary Air Inlet Filter Replace every 500 hours or 1 Do not attempt to clean or reuse the month of operation or as air inlet filter necessary Battery Pack Recharge every 90 days of Actual life depends on history of storage use and storage Replace every one year or as necessary O Sensor Replace as necessary Actual life depends on history of use and storage Air Inlet Muffler Replace annually or as Actual life depends on history of necessary use and storage Ventilator Outlet Port Replace annually or as Actual life depends on history of Muffler necessary use and storage Pneumatic Unit Replace every 15000 hours of operation or as necessary Other accessories Follow the manufacturer s instructions 74 VersaMed Vent201 Service Manual 5 2 Preventive
84. inum bracket oriented foam side down onto the studs protruding from the LCD shield Thread the 2 4mm lock nuts onto the studs While pressing down on the center of the bracket tighten both lock nuts Attach the green LCD ground wire to the corner of the LCD shield with the 1 3mm x 14mm Phillips head screw and lock washer Position the front enclosure standing up so that it is approximately 4 inches from the rear enclosure Connect the inverter cable to the top of the electronic module Connect the ribbon cable from the bottom of the electronic module to the interface PC board located in the middle of the front enclosure Verify that the connector s side retaining clips are snapped into place Issued 15 Aug 05 117 9 Connect the ground cable to the spade terminal located just above the outlet port 10 Connect the three 3 tubes to the barbed fittings located along the bottom of the inside of the front enclosure Be sure to reconnect them to the same locations that they were removed from a The tube from the outlet port tee is connected to the left most fitting when viewed from the inside b The blue tube or tube with a blue stripe is connected to the right most fitting c Theremaining tube is connected to the last remaining fitting 11 Bring the front and rear enclosures together Orient the tubing and cables so that none are kinked or crimped 12 Place the unit face down on the protective surface Und
85. is activated and temporarily replaces the date time field at the bottom right area of the display Additionally a bell symbol appears with a black X crossing it out A short press on the silence key reactivates the timer to 2 minutes A long press 1 second of the silence key cancels the operation e 100 O This key provides 3 minutes of 100 oxygen delivery and 2 minutes of alarm silence during suction procedures A second press of the key cancels the process This key is only active during ventilation and will not work in Standby mode e Manual Breath This key enables the operator to deliver a single breath on demand In CPAP PSV ventilation mode where there is no definition for a machine breath the manual breath will be set according to the default volume control for the specified patient weight 44 VersaMed Vent201 Service Manual e Hold This will invoke an inspiratory or expiratory hold maneuver on an upcoming breath Pressing the key once will initiate an inspiratory hold maneuver while pressing this key twice will initiate an expiratory hold maneuver If the hold key is pressed again the hold maneuver will be canceled Some units may not be equipped to support this feature e Clear This key is used to mute the alarm sound for 30 seconds and minimize the red alarm warning pop up message If this key is pressed again within the 30 seconds the alarm warning reappears A long press 1 second clears all inact
86. ive green alarm messages at the bottom left of the display This key also aborts the last operator action and returns to the previous position It is similar to the escape key on a computer keyboard 3 6 3 LED Indicators The front panel keypad also includes the following LED indicators e Alarm This red LED flashes during an alarm condition It also lights briefly whenever the rotational control or keypad is pressed or when the audible alarm volume is adjusted e Charge This amber LED lights when the ventilator is connected to an external AC or DC power supply e On This green LED lights whenever the unit is powered up 3 7 Ventilator Operation Please refer to the Operator s Manual Section 3 and 4 for in depth information Issued 15 Aug 05 45 Section 4 Theory of Operation The Vent is a positive pressure mechanical ventilator This section describes the ventilator s components and shows diagrams of the electro pneumatic system The Vent201 ventilator operates by means of continuous interaction between the following modules e Pneumatic Unit e Electronic Module e LCD Display e Interface Board e Power Pack Assembly 4 1 Pneumatic Unit The pneumatic unit provides the mechanics for ventilation and it is the heart of the ventilator It is the most important component and the key to understanding the entire system The pneumatic unit is divided into the following see Figure 4 1 e Blower Assembly Turb
87. ize inadvertent reset or user activation of the hard switch The 12V output is switched whenever the 5V supply is above a threshold Only the charge circuit is powered whenever AC or external DC is plugged in using 12V from VSUM Issued 15 Aug 05 69 4 2 4 7 Status Block The status block provides information to the main board about the external sources that are present The voltage from the source is compared with a reference voltage to provide a logic bit and a LED indication when the source is present 4 2 4 8 Motor Driver The motor driver provides a high current variable voltage to the motor A PWM signal from the main board controls a driver chip which switches power MOSFETs alternately connecting the motor to a 12V source or to the ground The motor coils are thus presented with a voltage which is proportional to the duty cycle of the PWM signal which in turn controls the speed of the motor A voltage is provided to power the motor Hall effect sensors The motor can be halted in case of a malfunction by switching off a power MOSFET between the motor negative terminal and the ground A brake function is provided which connects the motor terminals together via a low resistance power resistor The motor can also be stopped by effectively disconnecting the motor driver whereupon the motor will decelerate passively 4 2 4 9 External DC DC Converter and External DC Source The DC sources are connected to the back panel of the v
88. l go above the baseline If there is a leak along the tubing of the positive port the flow graph will go below the baseline The following steps will determine which branch the leak is located 1 Setup the ventilator and patient circuit as outlined in Section 6 2 4 page 90 2 Observe whether the flow offset on the flow graph is above or below the baseline 0 cmH O The flow graph range may need to be set to 60 to gain enough resolution to visibly detect the flow offset 3 If the flow is above the baseline then the leak is along the left side negative port 4 If the flow is below the baseline then the leak is along the right side positive port 8 2 5 5 Negative Flow Port amp Patient Pressure This branch of the pneumatic measurement system has the most connection junctions This is because it shares the flow signal with the patient pressure To isolate the leak location conduct the following steps Issued 15 Aug 05 153 Disassemble the front enclosure from the rear enclosure as outlined in Section 7 4 3 2 Enclosure Disassembly page 114 Remove the electronic module from the rear enclosure as outlined in Section 7 4 4 2 Electronic Module Removal page 119 Remove the top cover and tubing cover from the electronic module as outlined in Section 7 4 8 Electronic Module Cover Removal page 130 steps 1 5 Orient the opened electronic unit on its side so that the zeroing purge board is f
89. low out through the ambient port when the gate is in the 100 position This valve has a multiple functions The first is as a safety device The second is to further reduce the small amount of pressure from the demand valve down to ambient pressure This assures that both the O2 port and the ambient port of the O2 mixer are exactly equal in potential The third function is to provide a path back to the air inlet for all of the solenoid bypass functions when the valve is in the 10076 O2 position VersaMed Vent2o1 Service Manual This functionality of this component is automatically checked during the VVT 4 1 2 4 Valve Controller This system consists of a stepper motor and a mechanical linkage to the proportioning valve It can turn in either direction and drive the valve to a precise position based upon feedback from the O sensor It takes approximately 1000 steps move the valve from one extreme to the other It is powered by the 12V DC supply and draws 17 amps The mechanical linkage consists of a worm gear cam shaft spring and coupling It is lubricated with medical grade silicone grease The microswitch actuation cam is also attached to the main shaft This system is automatically checked during the VVT This assembly cannot be serviced because disassembly of the entire pneumatic unit is required However this system is historically reliable and seldom is the cause of an oxygen problem 4 1 2 5 Valve Limit Switch O
90. lve or one of the front panel luer connectors will develop a leak There are approximately 50 possible leak points Without a method of leak isolation a single problem can become time consuming and tedious There is usually no audible hiss to help isolate the root cause and visual inspections of suspected areas can escape detection Additionally the flow graph on the display can be very misleading if it is interpreted literally Refer back to Figure 4 2 Pneumatic Unit Overview on page 48 and Section 4 1 6 1 Wye and Flow Sensor on page 54 to familiarize yourself with the patient circuit s role in the pneumatic system The following diagram shows the pneumatic sensor s system components and pneumatic wiring All components are shown in their relative sizes and positions Issued 15 Aug 05 149 Zeroing Purge Board Female Luer Exhalation Valve Blue Dot Purge Pump 1 0 MG1 Of F LI EHE Ventilator Outlet i IN a cm Front Panel Connectors To Lower Port To Upper Port Male Luer N N gt S e I Pressure Pressure Sensor X pd A Flow Sensor U58 i XS Main Board Figure 8 6 Pneumatic Sensors Connections 150 VersaMed Vent201 Service Manual 8 2 5 1 Root Cause Pneumatic vs Electronic The first step of isolating the root cause of a VVT flow sensor leak is to determine whether the problem is pneumatic or electronic It is pos
91. me approximately 60 minutes can be guaranteed only if it is used according to the instructions provided in the Operator s Manual Old or used non functioning batteries and oxygen sensors must be returned to the place of purchase or to a place where they can be properly disposed of Batteries and oxygen sensors must not be discarded with ordinary waste A high voltage of 1800 Vrms exists on the DC AC inverter unit Do not touch this unit for at least 5 minutes after the ventilator is powered off Only genuine VersaMed replacement parts should be used Failure to comply may seriously impair the ventilator s performance safety or reliability Alteration or repair of the Vent201 beyond the scope of the service and maintenance instructions or by anyone other than an 22 VersaMed Vent2o1 Service Manual authorized VersaMed service person could result in the product s failure to perform as designed 1 4 Labels and Symbols 1 4 1 Symbols The following IEC 601 1 symbols appear on the ventilator Refer to documentation for further information Potential equalization Ground Point Direct Current DC and Alternating Current AC Dangerous voltage Type BF equipment Defibrillation proof Type BF applied part IP54 Degree of protection provided by the enclosure dust protected and splash proof Issued 15 Aug 05 23 1 4 2 Labels AC Connector AC IN 100 240V 50 60Hz 1 6A AC Fuses le 15AL 250V BM
92. move the 2 3mm x 8mm Phillips head screws and 4mm washers located on each end of the PC Board Disconnect the green ground cable s from the interface board Disconnect the front keypad 9 pin flex cable assembly from the interface board Disconnect the front keypad 2 pin flex cable assembly from the interface board Identify the interface board type and follow the corresponding steps 128 VersaMed Vent2o1 Service Manual a Front enclosure has a speaker i Disconnect the blue 6 pin encoder connector and white 2 pin speaker connector from the interface board ii Slide the interface board up vertically to remove it from the front enclosure b Front enclosure has no speaker i Orient the front enclosure so that the front is facing up ii Use the slot bladed screwdriver to pry the rotational control knob off of the encoder shaft iii Use the 11mm nut driver to remove the nut and lock washer from the mounting threads of the encoder iv Orient the front enclosure face down and pull the encoder out of the mounting hole v Slide the interface board up vertically to remove it from the front enclosure Interface Board Mounting Screws amp Washers 2 Ground Cable Connector Encoder Cable Connector opeaker Ribbon Cable Connector Connectors 2 opeaker Interface Board Figure 7 15 Front Enclosure Inside View 3 7 4 7 3 Interface Board Installation 7 Route the front keypad 2 pin flex ca
93. n external power supply connect the appropriate power cord to the AC or the DC power inlets Once the ventilator is in operation icons located at the bottom of the screen indicate the use of an external power source When connected to AC power the 3 prong AC plug symbol is displayed When disconnected from AC power the symbol is displayed crossed out with a red X When connected to an external DC power source such as a battery the text EXT appears in blue When no external power source is detected the text No EXT appears in black If the text EXT flashes in red the external battery voltage is low and needs to be substituted or recharged WARNING TO PREVENT HAZARD OF ELECTRICAL SHOCK o Connect the ventilator power cord to a properly grounded outlet Replace the power cord immediately if damaged or frayed Issued 15 Aug 05 33 External DC AC Power Input Figure 3 1 External AC and DC Power To prevent accidental disconnection of the AC power card secure it in place with the cable clamp as shown When connected to an external DC and or AC power supply the charge LED on the front panel is ON This indicates that the internal battery is being charged 3 2 Internal Battery The Vent201 contains an internal battery that can supply up to 2 hours of power depending upon the ventilator settings and the initial battery charge level The ventilator automatically switches to the internal battery when
94. n the Alarm Settings Options menu The default value is 8 5 Press Continue if there is an audible tone or Failed if there is none Another prompt will appear asking if the second alarm tone is audible 6 Press Continue if there is an audible tone or Failed if there is none The VVT Instruction window will appear 02 VersaMed Vent201 Service Manual 6 2 5 2 Pressure Tests Block the patient circuit with the 22mm cap or equivalent 2 Press OK and the unit will automatically run through a series of tests for about 30 seconds As it is goes through each step it will display an OK or Failed next to it The results items will continue to accumulate throughout the rest of the test If a calibration manometer is available and is known to be free from leaks block the patient circuit with it instead and compare the pressure reading from the manometer with the pressure reading from the display s left side bar graph This is an opportunity to determine full scale accuracy If the two pressure readings differ by more than 3 cmH20O recalibrate the pressure gt 8o T a egy 7 SIMU Uctel ra Ventilator Verification gt a an Fi Start the WI process EP 5 TUE UUT Instruction Block the flow sensor Press OK when ready o Skt ete cm 1 e B 0 CJ No EXT u vic deni Figure 6 5 Pressure Tests ITE da ji IIM Issued 15 Aug 05 93 Figure 6 6
95. nch is occluded the left side pressure bar will rapidly deflate if there is a leak along this line When the check valve purge pump branch is occluded the flow offset will return to zero if there is a leak along this line The flow graph range may have to be reset to 40 lpm to observe the flow offset By continuing to occlude the suspected branch off of the main line and running the first part of the VVT you can quickly confirm that flow sensor leak now passes Issued 15 Aug 05 155 Figure 8 7 Test Setup Unit Operating Disassembled BACKUP MODE ACTIVATED restore previous mode ES No Leak Leak Figure 8 8 Flow Graphs Occluding the Negative Flow Sensor Port 156 VersaMed Vent201 Service Manual 8 2 5 6 Positive Flow Port To isolate a leak that was determined to be along this branch follow all of the steps and considerations outlined in the previous section The main difference is that the criteria for determining leak vs no leak on the flow graph are exactly the opposite Normally when there is no leak present if you occlude the positive port sensing tube the flow graph trace will go in a positive direction or hug close to the baseline depending upon how fast the tube is occluded Even if the unit is trying to ventilate the flow graph trace will remain in the positive region see Figure 8 9 If there is a leak in front of the occlusion the flow graph will go negative
96. nob is 180 from the flat part of the encoder shaft and push it on 13 Assemble the front enclosure to the rear enclosure as outlined in Enclosure Assembly Section 7 4 3 3 page 117 7 4 8 Electronic Module Cover Removal and Installation 7 4 8 1 Tools amp Equipment e Screwdriver Phillips 1 130 VersaMed Vent201 Service Manual 7 4 8 2 Electronic Module Cover Removal CAUTION Use ESD protection when removing the cover from the electronic module 1 Toexpose the edges of all the PC boards and the top side of the zeroing purge board a Remove the electronic module as outlined in Section 7 4 4 2 Electronic Module Removal page 119 b Remove the 4 4 Phillips flat head screws from the top of the electronic module see Figure 7 16 c Remove the 2 4 Phillips flathead screws from the left side of the electronic module d Remove the 1 4 Phillips head screw lock washer and ground tab from the left side of the electronic module and lift off the cover 2 To gain access to the sensor tubing connections at the transducers a Remove the 4 4 Phillips flathead screws from the tubing cover located at the bottom of the electronic module and lift off the cover 3 To gain access to the power supply and switching board a Remove the 2 4 Phillips flathead screws from the front right top corner and rear left top corner of the electronic module b Lower the right side hinged cover of the electronic mod
97. o OFF WARNING If the power switch is set to ON the internal battery will continue to supply power to the PC Boards 1 3 2 2 Calibration and Verification Test After any servicing of the Vent201 ventilator perform a Calibration and Verification Test according to the instructions in Section 5 and Section 6 Issued 15 Aug 05 21 1 3 2 3 Handling PC Boards The PC boards contain components that are highly sensitive to static electricity When coming into contact with circuit boards containing sensitive components you must take precautions to avoid damaging the components ESD protection Always use a grounded wristband and grounded work surface when working with ESD sensitive components Adequate service tools must also be used PC boards spare or exchanged parts must always be kept in protective packaging for ESD sensitive devices Remove and insert the PC boards very carefully to avoid damage to the connectors 1 3 3 Important Safety Considerations Specially trained personnel must service the Vent201 at the specified periodic intervals described in Section 5 Any service or maintenance must be noted in a log book provided for that purpose in accordance with legal and civic regulations It is recommended that service be performed as part of a service contract with VersaMed The internal battery must be replaced every every year according to the instructions in this Service Manual The stated battery backup ti
98. olume measurement The high velocity flow from the test lung lowers the pressure of the first port port creating an artificial lower exhale volume The first set of Vent201 screen captures below Figure 8 11 show the effects of an undersized test lung for the application settings Note the high inspiratory pressure as well as the sharply spiking velocity of the exhale flow with a significantly low measured exhale volume Clinically this high amplitude short period exhale waveform is most like a patient cough and is not a common steady state flow pattern The critical point is that the analysis of the flow graph can lead you to the root cause and corrective action In this case the proper remedy for this situation is replacement of the 1 liter test lung with a 2 liter test lung and installation of an Rp20 resistor Issued 15 Aug 05 159 1 Liter Test Lung no resistor 1 Liter Test Lung w Rp20 resistor 2 Liter Test Lung no resistor 2 Liter Test Lung w Rp20 resistor Figure 8 10 Flow Graphs High Velocity Exhale 8 3 5 MAQUET Siemens 190 Test lung Two 2 characteristics of this lung interfere with correct tidal volume measurements e The test lung has a built in pneumatic resistor with a value of Rp4o e The connector fits into the 15mm F connector of the patient circuit wye The high velocity jet that is emitted from the test lung orifice lowers the pressure of the second port port creating an
99. on is verified but still fails VVT when it is reinstalled into the unit there may be a problem with its position relative to the pneumatic unit s O intake port Earlier versions of the O2 inlet pipe utilized NPT type threads and were sealed with Teflon tape This could cause the demand valve to be positioned ahead of the intake port of the pneumatic unit While the flexible silicone tubing used to connect the demand valve to the intake port compensated for variability in distance over time as the tubing lost flexibility the seal would leak and the demand valve would fail to detect the back pressure necessary to close and shut off O flow If the connecting silicone tube is viewed from the side the offset from the vertical axis should be discernable To remedy the problem do the following Issued 15 Aug 05 145 1 Remove the female DISS fitting and nut gland from the O inlet pipe using a 3 8in open end wrench 2 Remove the existing Teflon tape completely from the threads of the fitting Cut a 1 5 1 75in L x 0 5in W piece of Teflon tape With the threads end of the fitting facing you wrap the tape clock wise around the threads 5 Install the DISS fitting and nut gland into the O2 pipe manifold so that 1 8in of threads is visible 3 or 4 threads When the demand valve is properly installed onto the O inlet pipe assembly there should be a 70mm distance from center to center See Figure 8 2 DISS Fittin
100. on tests were completed successfully or a WARNING window will appear stating that errors were detected during VVT 96 VersaMed Vent201 Service Manual xli uu SIMU Uctrl A ea Verification Fi Flow performance OK Flow zeroing OK 21 Fi02 OK 02 Pr Switch on 21 OK Demand Value leak OK 1887 Fi02 OK 02 Pr Switch on 1887 OK Battery OK Se Note Press Finish for the LAST test Rosana REA mis iggers Figure 6 12 Watchdog Timer Tests I DE PIP v SIMU Uctrl TEES 40 UARNI NG Ventilator verification tests completed successfully Mel ELISELE HE ls L LL SUL Hae ig EL ISELE HE Rs LE LL SUL VVT Passed wut ance Figure 6 13 VVT Test Results 3 Press OK and the weight selection window will appear Select a weight and the unit will be in the Standby mode If the ventilator does not pass the VVT verify that the flow sensor and exhalation valve control tubes are adequately mated to the front panel luer fittings perform the calibration procedure and repeat the test Issued 15 Aug 05 97 6 3 Functional Verification Test Procedure The Functional Verification Test is a series of operational simulations designed to qualify all of the critical functions of the ventilator 6 3 1 Purpose This procedure verifies ventilator functions and performance not measured or detectable by the VVT alone 6 3 2 Scope This procedure applie
101. ond to patient triggers b After the first minute the unit does automatically switch back to previous mode after detecting three 3 patient triggers within a minute Reset the rate to 12 bpm 3 5 3 3 Tube Disconnect Alarm Disconnect the external analyzer O sensor and patient circuit from the ventilator outlet port Verify that a Theaudible alarm sounds continuously b Ared pop up Warnings window appears indicating Tube disconnect c Ared Tube disc indicator appears in the lower left part of the display window d The mode field changes to a blinking DISCONNECT Issued 15 Aug 05 103 Figure 6 19 Tube Disconnect Alarm 3 Connect the patient circuit to the ventilator outlet port and verify that the alarm automatically recovers 6 3 5 3 4 Patient Disconnect Alarm Disconnect the test lung and Rp20 resistor from the patient circuit Verify that a Theaudible alarm sounds continuously b Ared pop up Warnings window appears showing Patient disconnect and a red Pat disc indicator appears in the lower left part of the display window Figure 6 20 Patient Disconnect Alarm 3 Connect the test lung and Rp20 resistor to the patient circuit and verify that the alarm automatically recovers 104 VersaMed Vent201 Service Manual 6 3 5 3 5 Sensor Disconnect Alarm 1 Disconnect the patient circuit flow sensor connectors two clear lines at lower left from the ventilator front panel
102. ontyaes 89 PiU 0 A OVIT 2 AAA 89 Figure 6 3 Entering the Maintenance Window eere 92 ligureo f Enteans V Viki 92 Petrel Pressure estadia E 93 Ligure 0 6 Pressure Test Results oed peint bic Do Armee testa 94 MS oV Lestat alone apela 94 Metre bor Or Tests 2 taa aa 95 Rrure 0 7 C Teste 10076 erat platos 95 Picaro PU Bater Testi 96 Ingure o LT ISeconnect AG POWER tion 96 Figure 6 12 Watchdog Timer Tests vivos cou LEE ceut ntc lad Pu EO HA ER ReGU 97 Moure 6 19 V VT Test RESONS ea E N N Qu suoi 97 Figure 6 14 External O gt Analyzer Test 56 Ups nonet e a 29 Figure 6 15 Internal O Measure Men ancor oe aerarii Gades Qc oxide o abe 100 Metre 6 16 100 0 15ucton Modesto strass osos tweed camas ici 101 Herec 1 1 Fite BSPRESSUEO O a 102 Ido ues Bova OQ lore Wa Ls e INCA ioter tendere er em er een S 103 bieureo 19 Tube Disconnect AX Var tia oe t Cose ia Co opta oc iere Pudet ed antes 104 Iieure 6 20 Patient Disconnect Alai 104 Figure 6 21 Sensor Disconnect Alisa saciar 105 Ligure 7 1 RS 232 Cable to V eN DOT see na piibds 107 Figure 7 2 Upgrade Vent201 Software Screen eere 108 Figure 7 3 Upgrade Vent201 PC Application Screens ess 108 Figure 7 4 ivDownload PC Application Screens eene 111 Pisure755 Update Packat e Kennel de ce dedi Cue aget Ue ip qoe Ded 113 Figure 7 6 Enclosure Rear View 4t lanas 116 Figure 7 7 Front Enclosure
103. or lie in the negative range see Figure 8 9 oop BACKUP MODE ACTIVATED restore preu ious mode No Leak Leak Figure 8 9 Flow Graphs Occluding the Positive Flow Sensor Port 8 3 Exhale VT Accuracy In general after performing a calibration and subsequent VVT there should be a high confidence level in the volume accuracy The patient circuit would have to be defective and unusable or the strokes during volume calibration would have to be unusually fast to cause a miscalibration In clinical applications there is a wide variety of normal reasons for low exhale tidal volume such as leakage at the interface inspiratory time set too low or pressure limitation set too low This section will deal with volume inaccuracy issues that can be verified on the test bench under controlled conditions Issued 15 Aug 05 157 8 3 1 Inhale VT Accuracy The Ventooi patient circuit flow sensor measures flow in both directions The pressure calibration is independent of the flow calibration or the patient circuit that is used It is also easy to compare the pressure that is generated to a variety of external pressure measurement devices At the very least it can be compared and verified by the certified manometer that was used to calibrate the unit The VersaMed 2 liter test lung P N 910V0005 01 has a consistent compliance of approximately C24 This means that for every 24 ml injected into the test lung it will generate 1 cmH5O
104. or or IVxxx event where xxx is the serial number of the unit CAUTION The downloaded files will be date time stamped with the PC s current date time setting If the date or time values are incorrect either adjust the PC clock or include the correct date in the filename 10 These file s may be sent to technical support techsupport versamed net for evaluation Issued 15 Aug 05 111 7 3 Option Package Update The Vent201 ventilator contains all of the software needed to run under any configuration as long as the hardware is present By manually entering a key code that is unique to each unit different ventilator features can be enabled or disabled The code is provided by the VersaMed Support Services only The activation of some features may require special permission since it may affect clinical safety 7 3 1 Purpose The purpose of this procedure is to provide clear instruction for reconfiguration of the operational modes and features of the ventilator 7 3 2 Scope This procedure applies to Vent201 1 3 and 1 4 ventilators manufactured by VersaMed Medical Systems Inc and running software version 9 01 or higher 7 3 3 Tools amp Equipment e New Package Key Code as generated by Support Services 7 3 4 Procedure 1 Connect the AC power to the ventilator and switch it on Select the 70 kg patient weight in the opening screen 2 From the Main Menu select the Maintenance option A Caution window will app
105. out or Module Part intervention technical log defective Electronic Module Unit was running AC fuse is blown Replace AC fuses 137A3150 on battery power or discharged or recharge AC power battery battery disconnect in event log Unit doesn t Charge LED AC Fuse blown Replace both AC 137A3150 boot up on doesn t light with fuses and charge battery power AC power cord battery for 8 hours Issued 15 Aug 05 139 Symptom Possible Cause Part Number Battery run time too short or Battery indicator never displays full Battery indicator displays empty after recharge and gas gage reconditioning Unit displays Call Service Battery Disconnect or Battery Damaged error Charge LED lights with AC power cord plugged in Unit continues to function but displays Low Battery or Empty Battery alarm Unit goes into functional failure but no Empty Battery Alarm Replacement Power Pack displays empty battery icon Charge LED lights with AC power cord plugged in Battery discharged Battery gas gage accumulated too much error or improperly initialized Battery capacity is inadequate Defective Electronic Module Power Pack fuse is blown Charge battery for 8 hours Charge battery for 8 hours discharge battery until empty then recharge battery for 10 hours Replace Power Pack 503A0012 Replace Electronic Call Service for Module Part
106. p of the black LCD mask so that the shield cutout is facing right and the LCD screen is facing down 5 Plug in the backlight connector into the inverter board so that the red wire is up 6 Install the 2 3mm x 14mm Phillips head screws and lock washers into the upper right and lower left holes of the LCD shield Issued 15 Aug 05 127 Position the green ground wire and tab between the LCD shield and the inverter cable clamp and install the 3mm x 18mm Phillips head screw lock washer and washer Assemble the front enclosure to the rear enclosure as outlined in Section 7 4 3 3 Enclosure Assembly page 117 7 4 7 Interface Board Removal and Installation There are two 2 versions of the interface board e The older version has a hard wired encoder two 2 sounders 16 pin main connector and one 1 ground point e The newer version has an encoder connector speaker connector and one 1 sounder 20 pin main connector and two 2 ground points From an assembly viewpoint the only difference is that the encoder may have to be removed along with the interface board 7 4 7 1 Tools Equipment e Screwdriver Phillips 1 e Pliers needle nosed e Nut driver 11mm To remove amp install encoder e Screwdriver Slotted To remove amp install encoder 7 4 7 2 Interface Board Removal e Disassemble the front enclosure from the rear enclosure as outlined in Section 7 4 3 2 Enclosure Disassembly page 114 Re
107. ping carton are well suited for this purpose 2 Detach the roll stand adapter plate from the bottom of the unit by removing the 4 3mm x 8mm Phillips head screws and lock washers 114 VersaMed Vent201 Service Manual 3 Usethe hex key to remove the 2 4mm x 30mm screws and washers from the bottom rear of the enclosure see Figure 7 6 Enclosure Rear View 1 page 116 4 Liftthe ventilator carrying handle and use the hex key to remove the 2 4mm x 50mm screws and washers from the top rear of the enclosure see Figure 7 6 5 Stand the unit back to an upright position and pull the front enclosure apart from the rear enclosure approximately 4 inches 6 Disconnect the three tubes from the barbed fittings along the bottom of the inside of the front enclosure Be sure to note where they were connected See Figure 7 7 page 116 7 Disconnect the ribbon cable from the interface PC board located in the middle of the front enclosure See Figure 7 7 and Figure 7 8 page 116 8 Disconnect the green ground wire and receptacle from the pneumatic unit just above the outlet port 9 Disconnect the inverter cable from the top of the electronic module See Figure 7 7 and Figure 7 8 page 116 10 With the LCD cable still tethered lay the front enclosure face down on the protective surface It is best to orient the front enclosure so that it is facing you upside down with the tethered LCD cable towards the right
108. piratory Rate bpm High 4 80 Low 1 77 Minute Volume L min High 1 99 Off Low 0 60 Inspiratory Pressure High 4 80 Low 1 77 cmH20 FiO 76 High 22 100 Low 21 99 Apnea Time sec 5 120 Leak 76 0 100 Low Tidal Volume 76 15 85 Off Inverse I E Ratio On Off Patient Circuit Disconnect On Off A Bi Level only other modes optional Alarm Volume Level 1 10 Loudness 2 6 Additional Alarms and Indicators 2 6 1 Alarms Low O Pressure Patient Disconnect AC Power Disconnect Tube Disconnect Issued 15 Aug 05 31 Low Battery Check Sensor Empty Battery High PEEP battery Disconnect Service Notice Over Temperature Need Cal Sensor Disconnect Auto Start Patient Circuit Failed 2 6 2 Indicators and Icons Power Source Breath Type Internal Battery Charge Level Zeroing Alarm Silence and Countdown Timer Purging Date and Time 10076 O Suction Mode LEDs On Charge Alarm External DC Work Hour Counter VersaMed Vent2o1 Service Manual Section 3 Installation and Setup 3 1 External Electrical Supply The Vent201 can use either external AC or DC power and is supplied with a hospital grade AC power cord The AC and DC sockets are located at the back of the ventilator see Figure 3 1 CAUTION Before connecting the ventilator to an AC or DC outlet verify that the external power supply is the correct voltage and frequency When the ventilator is operated from a
109. ppears next to the FiO field and the 2 minute alarm silence count down timer is initiated in the time date field 100 VersaMed Vent201 Service Manual 2 Verify that the FiO delivery elevates to 10076 nominal SIMU Uctrl Pci 80 aaa 8 6 coa m Xs mENU Figure 6 16 100 O Suction Mode 3 During the first 2 minutes detach the test lung and Rp20 resistor and verify that the audible alarm sounds only once and a red Pat disc Patient disconnect indicator appears in the lower left part of the display window A Low press Low pressure indicator may also appear 4 Reconnect the test lung and Rp20 resistor and verify that the red Pat disc indicator changes to green 5 After the 2 minute alarm silence counts down to zero detach the test lung and Rp20 resistor Verify that a Theaudible alarm sounds continuously b A red pop up Warning window appears showing Patient disconnect c There is a red Pat disc indicator in the lower left part of the display window 6 Reconnect the test lung and Rp20 resistor and clear all alarms by long pressing the clear or silence button on the keypad 7 Verify that the FiO setting and delivery return to 21 one 1 minute after the count down timer expires Issued 15 Aug 05 101 6 3 5 3 Safety Alarms Test The Safety alarms test checks the following e High pressure e Apnea e Tube disconnect e Patient disconnect e Sensor disconnect
110. pplied adapter P N 504A0110 A0 3 5 1 3 Bacterial Filter A user supplied bacterial filter must be placed at the ventilator outlet Issued 15 Aug 05 41 WARNING The bacterial filter is intended to prevent the contamination of the patient circuit components and to prevent the penetration of bacteria excessive humidity and liquids into the ventilator Failure to use an adequate filter may cause severe damage to internal pressure and flow sensors which may result in ventilator failure It is recommended that an HME filter be used when connecting to the patient 42 VersaMed Vent2o1 Service Manual Air Inlet Filter Adapter CBRN Bacterial Filter at Ventilator Filter Outlet HME Filter at Patient Wye Figure 3 6 Filters Issued 15 Aug 05 43 3 6 Ventilator Controls The front panel of the Vent201 includes the rotational control knob and the keypad see Figure 3 7 Figure 3 7 Ventilator Controls 3 6 1 Rotational Control Knob Encoder The rotational control knob is used by rotating the knob in either direction to scroll through and highlight the various fields or values found on the display The choice is then selected by pushing in the control knob An audible click can be heard from the speaker 3 6 2 Keypad The five push keys on the keypad include e Silence This key is used to mute the alarm sound and minimize pop up messages When pressed a 2 minute countdown timer
111. pport versamed net 7 Allinternal tubing cables connectors and contacts are properly secured reliable and routed away from any moving component 8 Suspected defective component has been temporarily substituted and the unit re verified by OVT and VVT 138 VersaMed Vent2o1 Service Manual Table 8 1 Troubleshooting Guide Possible Cause Unit powers off Power Switch Gasket still Remove Power when the power doesn tlatch into present in switch Switch gasket See switch is the ON position body Power Switch released Sect Defective Replace On Off 135D0003 On Off switch switch Unit does not No continuity Defective Replace On Off 135D0003 power up on through the power On Off switch switch dd ad A Defective Replace Electronic Call Service for Electronic Module Part Module Unit powers up Green LED lights Wrong software Replace Electronic Call Service for but does not revision installed Module Part boot up or installation was interrupted Defective Replace Electronic Call Service for Electronic Module Part Module Unit powers up Defective Replace Electronic Call Service for but restarts over Electronic Module Part and over again Module Unit blows AC Defective Replace Electronic Call Service for fuse Electronic Module Part immediately Module upon power up Unit powered Error Code 1 or Power surge Replace Electronic Call Service for off without user Warm restart in drop
112. program The DiskOnChip DOC is designed for PC environments It is a flash disk that is fully compatible with hard disk emulation The monolithic design of the DiskOnChip ensures high reliability even when subjected to levels of shock vibration and temperature changes that would destroy a conventional magnetic disk drive When the ventilator is booted up the program is read into RAM volatile memory from the DiskOnChip Data that is unique to the specific unit Issued 15 Aug 05 59 such as calibration configuration last set parameters and the events and error logs are stored on the DOC non volatile memory 4 2 1 4 RS 232 RS 232 is a serial communication interface that conforms to the EIA232 standard The 7Ventzo1 uses this interface to download new software from an external PC to the ventilator to download collected data from the ventilator to external PC and for real time diagnostics and remote control of the ventilator The Vent201 uses a male DB 9 connector and communication is enabled by connecting a null modem cable from the ventilator to an RS232 port of the external computer The Vent201 uses comm port 1 Com1 while the external PC can be selected for Com1 through Com4 This port selection is a property of the VersaMed software application that is running on the PC The external computer must have a Com1 through Com4 available and unused by any other application such as a mouse modem PDA Sync utility or ano
113. r 630B0004 A0 Breathing Circuit Support Arm 620B0001 01 Oxygen Supply Hose six 6 feet DISS oxygen fittings 620B0002 01 Oxygen Supply Hose fifteen 15 feet DISS oxygen fittings 900K0004 01 Calibration Kit 1 calibration syringe 1 manometer 2 test lungs 2 Rp20 resistors 1 stopper 507A0052 B0 Remote Alarm Interface for central alarm system call for details Normally Closed 51K 507A0053 B0 Remote Alarm Interface for central alarm system call for details Normally Closed Phone Jack 507A0054 B0 Remote Alarm Interface for central alarm system call for details Normally Open Phone Jack 507A1020 A0 D C Power Cord 12 volt vehicle adapter 507A1022 A0 D C Power Cord 12 volt clip on adapters 910V0004 A0 Pneumatic Resistor 6mm Rp20 630B0001 01 Roll Stand w Handle and Mounting Bracket 375B0005 01 Hard Case for Ventilator Shipping and Transport 375B0004 01 Soft Case for Ventilator 504A0110 AO Adaptor for Bio Chemical Filter 920C0001 01 Calibration Syringe 500ml 920C0002 01 Calibration Manometer 910V0005 01 Test Lung 2 Liter 504A0050 A0 External Battery Assembly 110VAC 301B0001 01 12V External Battery 32Ah 801C0002 01 External Battery Charger 110VAC Issued 15 Aug 05 165 301D0001 01 External Battery Case Do 507A1019 01 External Battery Cable 630B0007 01 External Battery Holder for Roll Stand 504A0051 A0 External Battery Assembly 220VAC 80HB00T01 JTAVExemalBaley SUA
114. r output connected internally to the buzzer driver to a relay output normally open This output also filters out short pulses such as keypad clicks and latches on for 0 5 sec for filtering pulses from this output The connector also provides two signal lines and a 5V line If a female 8 pin RJ45 modular connector is present a VersaMed supplied cable of the desired output type must be used The following output types are available for both configurations of remote alarm e NO Normally Open Relay Output switch closure upon alarm e NC Normally Closed Relay Output switch closure upon alarm e NC5IK Normally Closed Relay Output with 51kOhm resistor in series switch opens upon alarm 4 2 2 10 SpO2 Provision has been made for a possible future add on to the main board enabling pulse oximetry measurements and alarms 4 2 3 Zeroing Purge Board The zeroing purge board is a daughter board of the main board Its function is to conduct periodic maintenance of the flow sensor lines The zeroing function is accomplished by momentarily switching both ports of the differential flow transducer to ambient pressure using two 2 small solenoid valves The unit recalibrates itself to a new zero value compensating for transducer drifts or changes in barometric pressure Simultaneously the sensor lines are held closed and no flow measurement is made during this short period 0 4 sec VersaMed Vent2o1 Service Manual This can be ob
115. r the following reasons Issued 15 Aug 05 161 e There is a leak at the patient interface usually the test lung e The test lung is bouncing or hitting against an object e There is a flow offset due to calibration error e The flow sensitivity is set too low If O2 repeatedly becomes unstable try setting the trigger sensitivities to Off and see if the O control and minute volume stabilize 8 4 4 Erratic Exhale Tidal Volumes Erratic exhale tidal volumes means that although the ventilator is set up to deliver consistent breaths you observe some breaths to be smaller than normal This problem is very similar to the previous one Section 8 4 3 Generally the ventilator is running in a volume control mode and the smaller breaths are extra breaths based on the pressure support settings You should see a pink person breath type icon accompanying these breaths Possible root causes are listed in the previous section 8 4 5 Low Pressure During Calibration or VVT If during calibration or VVT you observe pressures that are lower than normal the ventilator may be running on battery power Simply plug in the AC power and restart the calibration or VVT process 8 5 Setting Up the Ventilator for Static Pressure To aid the technician in the troubleshooting effort it may become necessary to change the ventilator parameters The following procedure will set up the ventilator so that it will hold a 20 cmH20O static pressure
116. reen and wait for a connection The ventilator card number and the current 5 W version will be displayed da e T 11 mn d X Erie d yrs um Re Figure 7 3 Upgrade Vent201 PC Application Screens 108 VersaMed Vent201 Service Manual 10 Press the INSTALL button on the application screen and verify that the progress indicator advances at the bottom of the application screen while simultaneously the loaded percentage increases incrementally on the ventilator screen 11 At the end of the software installation the ventilator reboots automatically After restart the message INSTALLATION COMPLETED SUCCESSFULLY will appear Press OK and then select the 70 kg default 12 Click OK on the PC screen pop up window and the install application will automatically close 13 Select the CONFIGURATION SCREEN option from the maintenance menu 14 Confirm that the Software version number is updated to the new value 15 While still in the Configuration screen select the Default FiO Setting and change the value to 21 if desired If no cursor movement is sensed by the ventilator for one 1 minute it will timeout and return to the Maintenance menu 16 Press the front panel clear button two 2 times to clear out of the Configuration and Maintenance screen and return to the Standby screen 17 Calibrate the unit and run the VVT 7 2 Technical Logs Download The Vent201 Technical Logs are two 2
117. roll8E nuca eea 51 HOS PIPALOLY l Caa 27 valve limit Switeh 51 seta lada 31 troubleshooting 147 eal VOR ME 27 AES trigger sensitivity 28 Ade Ld 37 Ventilator Verification Test 21 49 50 apuve DI beVOl ccseonsssvi nee deeas 51 58 73 75 76 77 78 79 82 86 90 CPAP ul a 27 97 138 ee a M alarmi soundiin ecaa 91 92 EIS D UU MM PIETY NN 95 S a ML RE 2 BIO WEG SO Ar 94 M OS 94 volume controlled 27 DAMEN 36 Pressure TOSS acento rafa 93 VERBO poe NIU troubleshooting 97 Adaptive Peak Flow 91 watchdog timer 96 IDSpIEatory TINE cris 27 VersaMed andar DIEA Uode inten E contacta 2 3 138 peak LOW escrita raton 27 volume SF 79 Pee elite eed 27 E C MEN 27 A o A uc 68 69 Leon e Ed 28 VVT See Ventilator Verification Test purge interval suse 31 watchdog timer 62 65 96 97 purging cycle interval 28 WAY COLT ies 53 67 159 recommended for troubleshooting zeroing purge board 56 66 142 PYOCE CULES rta 162 Issued 15 Aug 05 173
118. rom the side of the rear enclosure Be sure that the O ring remains on the side inlet port Slide the air inlet muffler straight out and simultaneously disconnect the blue air inlet tube Tilt the rear enclosure back onto the power pack handle in order to gain convenient access to the underside of the unit Remove the 4 4mm x 10mm Phillips head screws from the bottom of the rear enclosure Use the 11 16 inch and 9 16 inch Open End wrenches to loosen and detach the DISS collar to the demand valve Identify the O pressure switch type and disconnect the corresponding connector s a For the Silver colored metal switch which is threaded directly onto the O inlet pipe Follow the cable assembly coming out of the back of the pressure switch and disconnect the black 3 pin hanging connector b For the brass colored metal body which mounted to the back wall of the rear enclosure disconnect the two 2 crimped connectors from the tabs on the rear of the O pressure switch Disconnect the green ground wire assembly from the dual tabs located just above the outlet port 10 Pull the pneumatic unit straight out of the rear enclosure 122 VersaMed Vent2o1 Service Manual Air Inlet Filter a amp O ring 4 Air Inlet Muffler O Pressure Switch Demand Valve Air Inlet Tube Ground Point Pneumatic Unit Outlet Port Figure 7 11 Rear Enclosure Inside View 3 7 4 5 3 Pneumatic Unit Installation Rota
119. s 2 1 1 Ventilation Modes Assist Control A C e Volume Controlled A C Vctrl e Pressure Controlled A C Pctrl Pressure Controlled A C Pctrl e Volume Controlled SIMV Vctrl e Pressure Controlled SIMV Pctrl Continuous Positive Airway Pressure CPAP Pressure Support Ventilation PSV Adaptive Bi Level A BI LEVEL 2 1 2 Ventilation Performance and Controlled Parameters Respiratory Rate 1 to 12 1 bpm 12 to 50 2 bpm Tidal Volume 100 to 2000 mL Accuracy of Tidal Volume 10 or 10 mL whichever is Delivery from the set value greater Accuracy of Respiratory exhale 15 above 100 mL from actual tidal Volume Measurement reading or 10 mL below 100 mL Inspiratory Pressure Limit 5 to 80 5 cmH20 Inspiratory Time Adaptive Time or 0 3 to 3 10 seconds Peak Flow PIF Adaptive Flow M or 1 to 120 10 L min Spontaneous to 180 10 L min Oxygen Mix FiO 21 to 100 5 FiO 0 to 20 1 cmH20 or 10 whichever is greater Issued 15 Aug 05 27 Trigger Sensitivity Flow Off or 1 to 20 L min Trigger Sensitivity Pressure Off or 0 5 to 20 cmH20 PSV 0 to 60 10 cmH20 Positive Pressure Relief Valve 80 cmH O Controlled Pressure 5 to 80 5 cmH20 FiO at Power up 21 4076 60 100 selectable Purging Cycle Interval 1 2 5 10 or off 2 1 3 Power Supply External AC 100 to 240 V 50 60 Hz max 1 6 A External DC 12 to 15 V max 8 5 A Internal Battery Sealed Lead Acid
120. s determined by the spring characteristics which are chosen to match the requirement Since each valve can pop off independently there are actually two 2 safety relief valves This assembly cannot be serviced because disassembly of the entire pneumatic unit is required However this system is historically reliable and is seldom the cause of a problem This system is automatically checked during the VVT Issued 15 Aug 05 53 4 1 4 Filters and Mufflers Air is drawn into the manifold through a user replaceable air intake filter which provides highly efficient filtration of particles exceeding 5 microns The air passes through a muffler which reduces the noise level before going to the air intake hose The air intake muffler consists of baffling and sound absorbent foam The air inlet filter is screwed directly to this muffler through a 3 5 inch diameter hole on the left side of the ventilator housing There is also an O ring to assure a good seal The ventilator outlet port is also a muffler and consists of baffling and sound absorbent foam It is fastened to the pneumatic unit via a gasket adapter plate and o ring There is also a small diameter barbed connector for the blower pressure sensing tube 4 1 5 Cooling Fan The pneumatic unit cooling fan is directed towards the blower motor and solenoid valves to conduct heat away from these components 4 1 6 Patient Circuit Gas is transferred from the ventilator to the pa
121. s to Vent201 Version 1 4 ventilators manufactured by VersaMed Medical Systems Inc and loaded with software version 19 11 or higher This procedure should be performed after any repair software upgrade or annual preventive maintenance 6 3 3 Tools amp Equipment e QO supply 40 60 psi e QO supply hose Versamed P N 620B0001 01 or 620B0002 01 e Certified external O2 analyzer Puritan Bennett 7820 or equivalent e Test lung 2L Versamed P N 910V0005 01 e Pneumatic resistor Rp20 Versamed P N 910V0004 A0 6 3 4 Initialization 1 From a power off state connect the ventilator to AC power 2 Turn on the O analyzer and connect its O2 sensor to the ventilator outlet port and the patient circuit to the O sensor Connect the Rp20 resistor and test lung to the patient circuit wye Turn on the ventilator and select the 70 kg patient weight setting in the opening screen Set the pressure alarm P Limit to 60 cmH20 Press START and allow the ventilator and O2 analyzer probe to warm up for 15 minutes prior to the test 98 VersaMed Vent2o1 Service Manual IET AN Y YN j cy EJ n E j i7 fe AL TN WS n b iF e re 4 eT OG a 415 uhh ANS 5p BR i 2 ird be gt co i dd FS m 2 G M 4 Tor Lu M eo notte PR Ae on gt x DJ b i HH Figure 6 14 External O Analyzer Test Setup 6 3 5 Procedure The Functional Verification test procedure includes st
122. se Inhaler MDI adapter between the HME and the patient connection CAUTION Do not use an HME filter that appears to be contaminated or filled with water Use of a contaminated filter can interfere with the function of the Patient Disconnect alarm CAUTION Take care to remove the HME filter and install water traps on the tubes to prevent penetration of water into the ventilator or circuit valves CAUTION Do not clean or re use the single use breathing circuit or its components For correct handling of the Patient Circuit refer to the User Instructions that are packaged with every circuit 3 4 1 Patient Circuit Connection Before operating the system the following must be connected see Figure 3 5 e The inspiratory limb of the patient circuit to the ventilator outlet e The sensor lines to the luer connectors on the lower left side of the front e The exhalation valve control line blue to the single luer connector on the lower right side of the front There is a blue dot indicating the proper location Issued 15 Aug 05 39 Figure 3 5 Patient Circuit Connection WARNING Always perform an operation verification test OVT when connecting a new patient circuit to the ventilator CAUTION Use only breathing circuit accessories approved and or suppled by VersaMed or authorized VersaMed distributors When the ventilator is intended to be used clinically on a patient a bacterial filter should be placed betwe
123. served in the flow waveform on the ventilator display Every three 3 minutes at the start of exhalation the flow measures zero even though there is no change in the pressure graph There are also two 2 purge pumps teed off of the flow sensor lines and zeroing solenoids Their function is to pressurize the flow sensor lines and flush any condensate or obstruction that could interfere with an accurate measurement The purge pumps are capable of producing approximately 10 psi and are powered by the 12V supply The frequency is selected via the user menu The purging process is detectable on the front panel pressure waveform Some units are equipped with a zeroing board only 4 2 4 Switching Board The switching board is the power conversion and distribution utility board All power functions occur here including external DC power management The switching board contains all of the power interfaces and the motor driver The switching board handles the power functions of the system and performs the following functions e Switching between different power source e EMI RFI Filtering of DC sources e Protecting against over current and over voltage e Battery charging e Converting 10 15V Input to 5V Output DC DC e Power on off switching e Determining the status of connected sources e Motor Drive Circuitry The primary inputs to the switching board are e External power sources and internal battery e Motor control signals from t
124. sible that there is no actual leak and the unit only believes that there is a leak If there is no flow signal sent to the flow transducer during the pressurization portion of the VVT it should fail everything but flow sensor leak Conduct the following experiment 1 Setup the ventilator and patient circuit as outlined in Section 6 2 4 page 90 2 Runthe first part of the VVT as outlined in Section 6 2 4 Alarm Sound Tests page 91 and Pressure Tests page 93 several times and determine whether or not flow sensor leak fails each and every time This will help you to determine if the failure is borderline and avoid drawing false conclusions 3 Disconnect the two flow sensor lines from the left side of the front panel and repeat the test Patient pressure Solenoid 1 Solenoid 2 and Solenoid safety should fail due to the lack of a pressure signal e If Flow sensor leak is OK the cause of the failure is a pneumatic leak e If Flow sensor leak is Failed the cause of the failure is electronic If you have determined that the cause of the failure is electronic failing the VVT for flow sensor leak without the presence of a flow signal then conduct the Zero Sensors step of the Calibration procedure as outlined in Section 5 4 5 2 page 81 and repeat the VVT without the patient circuit attached If the unit fails VVT for flow sensor leak again then the electronic module must be replaced 8 2 5 2 Isolation of Internal T
125. t to the ventilator as well as the function of the one way valve on the inspiratory limb The O V T also checks the apnea detection function and audible alarm 6 1 1 Purpose The purpose of this procedure is to establish a method of properly verifying the patient circuit connections and functionality 6 1 2 Scope This procedure applies to Vent201 Version 1 4 ventilators manufactured by VersaMed Medical Systems Inc and loaded with software version 19 11 or higher This procedure should be performed after attaching a new patient circuit to the ventilator 6 1 3 Tools amp Equipment e Caps 22mm supplied with every circuit 6 1 4 Initialization 1 Connect the patient circuit to the ventilator 2 Power up the ventilator and select a patient weight setting in the opening screen 6 1 5 Procedure 1 Highlight and select O V T from the Standby screen O V T can also be selected from the Main Menu The O V T Instructions window will appear 2 Connect the caps to the patient circuit wye and exhalation valve opening and then press Start The system will pressurize to approximately 80 cmH20 for about six 6 seconds 88 VersaMed Vent201 Service Manual 0 U T NEU E e Please make sure the patient circuit is sealed BY CAPS in both ends patient and exhalation value opyri c Heri bs ri Er S i E S n E c 2005 by e Em eS e EN Figure 6 1 OVT 1 3 When prompted remove
126. ta llo auo tenebre eroi ide 127 7 4 7 Interface Board Removal and Installation 128 7 71 Tools Egu PME N avete dede ehe ores tipi as 128 7 4 7 2 Interface Board Remowval cessere 128 7 4 7 3 Interface Board Installation eren 129 7 4 8 Electronic Module Cover Removal and Installation 130 TAO TODOS EQUIP diia 130 7 4 8 2 Electronic Module Cover Removal eren 131 7 4 8 3 Electronic Module Cover Installation 132 7 4 9 Power Pack Disassembly and Assembly s 133 AOL TOOIS EQUIP isc 133 74 9 2 Power Pack Disassembly 5 tete ete ego aedis e edi mod ins 133 REI Power Pack Asset ae aaa 134 7 4 10 O Sensor Removal and Installation eren 135 Z4 IO0 T Tools EquiIpEIBODL s ent ME a 135 74102 Oo Sensor Removal zi UE t ERAN MA Com ea VE 135 7 4 10 3 O Sensor Installation eeeeeeerrreenn nennen 135 7 5 Battery Gas Gauge Initialization Procedure 136 PESA BOSSES A A ME tene e 136 Jos Goo MNT 136 7 9 9 VOOIS Ce Egui PMen tati 136 T bs Proceed an 136 Section 8 Troubleshooting 138 6 1 Troublesnoolig GUI eiii 138 8 2 Diagnostics and Repairs 1e eeeeere eene nenne 143 O2
127. te the shaft of the O2 mixer stepper motor by hand so that the 1 O microswitch actuating arm is in the center of the high area of the cam see Figure 7 12 123 Issued 15 Aug 05 is 1 4 E Figure 7 12 O2 Mixer Cam to Mid Point Position Place the pneumatic unit into the bottom of the rear enclosure Align the demand valve of the pneumatic unit with the DISS fitting of the O inlet pipe and hand tighten the collar 4 Place the green ground wire and tab between the front left leg of pneumatic unit and the mounting plate 5 Tilt the rear enclosure back onto the power pack handle in order gain convenient access to the underside of the unit 6 Beginning with the front left leg of the pneumatic unit install the 4 4mm x 10mm Phillips head screws lock washers and washers through the bottom of the enclosure mounting plate and leg Ensure that the first screw feeds through the ground wire tab of the front left leg 124 VersaMed Vent201 Service Manual Figure 7 13 PU Ground Point Locations 7 Usethe 11 16 inch and 9 16 inch Open End wrenches to tighten the DISS fitting to the demand valve Ensure that the demand valve does not twist and remains vertical on the pneumatic unit Apply the high pressure O to the rear DISS inlet and verify that the demand valve shuts off and does not audibly leak Disengage the O supply 8 Identify the O pressure switch type and connect the corresponding connec
128. the front panel Of the two luer connections the left port is more often misconnected although it can visually appear to be OK This system is automatically checked during the VVT 4 1 6 2 Exhalation Valve This valve is attached to the expiratory limb of the patient circuit Its main function is to close off the exhalation path during the inspiratory phase and to open during the expiratory phase allowing the patient to exhale It is also used for PEEP control The exhalation valve control line is color coded blue and is connected to the bottom right luer fitting Internally it is connected to the ventilator outlet and shares the blower pressure sensing line The exhalation valve control line is open to the top of the valve diaphragm During the exhalation phase of the breath cycle the patient s lungs are allowed to deflate until they reach the same pressure that is on both sides of the diaphragm At this point the exhalation valve closes and holds this PEEP value until something changes the equilibrium usually the next breath cycle This component is automatically checked during the VVT 4 1 6 3 One way Valve This valve is connected between the wye and the inspiratory limb of the circuit It prevents any flow from going back towards the ventilator and ensures that all inspired gas is exhausted out of the exhalation port This reduces CO rebreathing characteristics of the circuit while allowing for Issued 15 Aug 05 55
129. ther VersaMed application 4 2 1 5 VGA Display The CPU board supports LCD and CRT displays The LCD display connects directly to the CPU board which provides both power and data A TFT color display is currently in use but other displays can also be used The display uses dual compact fluorescent backlights that require a high voltage AC source supplied from an inverter The inverter is an off the shelf component which receives its input power from a connector on the switching board There is a standard DB 15 VGA connector for simultaneous external monitoring 60 VersaMed Vent201 Service Manual 4 2 1 6 Keyboard The CPU board supports a keyboard using a PS2 port It is intended to be used for factory servicing and has no useful purpose for the field A mouse is not supported 4 2 1 7 Ethernet The CPU supports a 10 100 Base T RJ45 port It is not active at this time and is reserved for future applications 4 2 1 8 PC Watchdog The PC Watchdog is a circuit that automatically monitors the PC This is a safety feature that will force the ventilator to resume operation in case of a temporary overwhelming malfunction In this rare event the unit will restart within 31 seconds while activating alarms WARNING This is fail safe feature and not a part of normal operation If this occurs the unit should be removed from service as soon as possible You should notify the VersaMed service department to make arrangements to ha
130. tient via the patient circuit The patient circuit consists of two standard 22mm corrugated hoses a wye with integral flow sensor and sensing lines exhalation valve and control line and a one way valve see Figure 3 4 4 1 6 1 Wye and Flow Sensor The wye flow sensor is a proprietary component that connects to patient interfaces such as ET tubes masks etc It has an integrated flow sensing system that connects to the ventilator front panel see Figure 3 5 The flow sensor portion of the wye is a differential pneumatic that measures the small difference in pressure at the two ports which are 1 2 inch apart This differential pressure is then translated to equivalent flow and direction by the electronic module VersaMed Vent2o1 Service Manual The flow sensing lines are connected to the ventilator front panel using medical luer fittings one male and one female which are connected to a differential pressure transducer located within the electronic module The flow sensor measurement is very dependent upon leak tight seals beginning with the differential ports of the flow sensor and ending at the transducer The closer a leak point is to the transducer the greater the error Thus for a 1 Ipm leak at the ET tube the flow would be measured accurately 1 lpm but for a 1 lpm leak located directly next to the transducer the flow measurement would be 140 Ipm The most common location of a flow sensor leak is at the luer connections to
131. tor s a Silver colored metal switch which is threaded directly onto the O inlet pipe e Route the cable assembly coming out of the back of the pressure switch under the blue air inlet tube and connect the black 3 pin hanging connector b Brass colored metal body mounted to the back wall of the rear enclosure e Connect the two 2 crimped receptacles coming from the back of pneumatic unit s main connector to the rear of the O2 pressure switch 9 Connect the green ground wire and crimped receptacle onto the dual tabs located just above the outlet port Issued 15 Aug 05 125 10 11 12 13 14 Align the air inlet muffler with the tracks found on the left inside of the rear enclosure and slide the muffler all the way to the back Connect the blue air inlet tube to the outlet of the air inlet muffler Install the air inlet filter onto the side air inlet port Ensure that the O ring was retained on the port If the air inlet filter does not install easily and without interference then the air inlet muffler was not inserted all the way back Install the electronic module as outlined in Section 7 4 4 3 Electronic Module Installation page 120 Assemble the front enclosure to the rear enclosure as outlined in Section 7 4 3 3 Enclosure Assembly page 117 7 4 6 LCD Assembly Removal and Installation 7 4 6 1 Tools and Equipment e Screwdriver Phillips 1 e Pliers needle nosed 7 4 6 2 LCD Assem
132. tor to AC power 2 Turn on the ventilator and select the 70 kg patient weight setting in the opening screen Set the pressure alarm to 60 cmH O Connect the ventilator with a patient circuit to the Rp20 resistor and test lung 5 Press START and allow the ventilator to warm up for 15 minutes prior to calibration 5 4 5 Procedure The Calibration procedure includes steps for the following Zero Sensors Pressure Sensors calibration PEEP RPM calibration Flow Sensor calibration Volume calibration O System calibration Issued 15 Aug 05 79 CAUTION The calibration process described in this procedure should be carried out sequentially and in full each time a calibration is required Failure to perform all of the steps in sequence can result in an un calibrated system Zero Sensors Volume and O calibrations may be carried out separately 5 4 5 1 Initialization 1 From the Main Menu select the Maintenance option A Caution window will appear stating that only trained service personnel should enter the restricted Maintenance area Select Yes and the Maintenance window appears Select the Calibration option and the Calibration window will appear listing the calibration steps 80 VersaMed Vent201 Service Manual Alarm Settingz Advanced Settings Restore Defaults Graphs Trends Loops Mechanics Log Book Main Window Caution Window Figure 5 2 Entering the Maintenance Menu
133. ube Leak The pneumatic sensing measurement system consists of three 3 main branches of tubing that are analogous with the three tubes that are connected to the ventilator front panel Issued 15 Aug 05 151 e Blower Pressure amp Exhalation Valve Control e Negative Flow Port amp Patient Pressure e Positive Flow Port CAUTION Although historically rare a leak at more than one site Is possible Although you can isolate the leak to one of these three branches without disassembling the unit the remedy will require you to at least remove the front panel Disassemble the front enclosure from the rear enclosure as outlined in Section 7 4 3 2 Enclosure Disassembly page 114 Do not disconnect any tubing or cables 8 2 5 3 Blower Pressure amp Exhalation Valve Control A leak that occurs along the blower pressure sensing tube and exhalation valve control line isn t actually detected by the VVT If the leak causes the blower pressure to be less than the patient pressure the exhalation valve will not be held totally closed The air flow that escapes out of the exhalation valve lowers the pressure at the flow sensing port and creates a small negative flow measurement The following steps will determine if the leak is located along this branch 1 Setup the ventilator and patient circuit as outlined in Section 3 4 1 2 Block the exhalation valve outlet 22mm male 3 Run the first part of the VVT as outlined in
134. ule Issued 15 Aug 05 131 Hinged Cover ocrews 2 EM Cover Z ocrews 7 Tu EE n Figure 7 16 EM Cover Screw Locations 7 4 8 3 Electronic Module Cover Installation Raise the right side hinged cover of the electronic module Install the 2 4 Phillips flathead screws to the front right top corner and rear left top corner of the electronic module 3 Position the tubing cover over the top of the electronic module and install the 4 4 Phillips flathead screws 4 Position the right angled cover over the top of the electronic module and install the 4 4 Phillips flathead screws 5 Install the 2 4 Phillips flathead screws to the left side of the electronic module 6 Install the 1 4 Phillips head screw lock washer and ground tab to the left side of the electronic module 7 Install the electronic module as outlined in Section 7 4 4 3 Electronic Module Installation page 120 132 VersaMed Vent2o1 Service Manual 7 4 9 Power Pack Disassembly and Assembly 7 4 9 1 Tools amp Equipment e Screwdriver Phillips 1 e Pliers needle nosed 7 4 9 2 Power Pack Disassembly 1 Remove the 4 3mm x 20mm Phillips head screw from the corners of the power pack see Figure 7 17 Grasp the black handle of the power pack and pull it straight out from its compartment see Figure 7 18 Remove the 5 3mm x 10mm Phillips head screws and lock washers from the back of th
135. ume level 31 save new calibration 86 analos FIIO ondas 62 VOMO 79 85 analog to digital converter ADC 62 ZETO BONS Sa 79 81 63 COMPU 59 65 appe sce atas reU Qni RE 31 88 I Dm 59 alarm test ssss 102 lors MR RE RERO 62 64 CPU board 59 See also main board Issued 15 Aug 05 169 DiskOnC DID densitate idis 59 external display 60 MEMO c oed m ta ate 29 60 specifications esses 59 motor interface eeeeeeeene 64 operating system 61 PC Watchdog 59 61 VGA connector eeee 60 controller valve limit switch 49 cooling fan 46 54 56 71 VEN undue uude A eta esed 24 cooling inlet maintenance eene 74 75 CPU board 56 60 61 62 64 71 demand valve 49 50 91 122 124 125 142 145 146 troubleshooting and repair145 146 digital to analog converter DAC 63 digital analog interface 62 63 Gis Play se See also LCD display EXENA Perras 25 specifications eeseeess 28 Easy Exalead 31 56 electronic module 46 54 56 57 118 120 122 126 130 131 132 139 140 141 143 154 removal and installation 118 21 electronic module cover removal and installation 130 32 ethernet connector 25 59 61
136. ure sensor This voltage is amplified by an instrumentation amplifier and filtered by a 4 pole analog filter The voltage is sampled by the analog to digital converter ADC for measurement of high flow levels The voltage is then filtered and amplified for measurement 62 VersaMed Vent2o1 Service Manual of low flows via a second ADC channel A reference voltage biases the measured voltages so that at zero flow the signal is in the center of the ADC input range Reference voltage may be either fixed or adjusted using a calibration digital to analog converter DAC 4 2 2 1 2 Pressure Sensors The system supports two pressure sensors Similar to the flow sensor pressure is converted to a low level voltage amplified and filtered However only a 2 pole filter is used and a second level of amplification is not required Reference biasing is also similar but is not at mid scale as pressure has a higher positive range than negative range i e the reference pressure would be positive The channels used are for patient pressure and blower pressure 4 2 2 1 3 Oxygen Sensor The oxygen sensor voltage is amplified and filtered in a single stage The ADC then samples the output voltage 4 2 2 1 4 Temperature Sensor An integrated circuit temperature sensor measures temperature which is presented without amplification or filtering to the ADC An analog multiplexer selects between the temperature channel and the low flow channel
137. ure of the O that it is exposed to At the beginning of the sensor s life the output is approximately 65 mV at 100 O and 15 mV at 21 As the sensor degrades the maximum output decreases When the sensor output at 21 O is less than 7 25 mV the Vent201 will no longer accept the calibration value and the sensor must be replaced The output value from the sensor is compensated for pressure and temperature via the internal software This means that there is usually a slight difference between external O analyzer measurements and the internal O2 measurement system The ventilator specification for O2 control is 5 FiO but when comparing the values to an external O2 analyzer additional tolerance must be added to compensate for the uncertainties presented by the external analyzer The rule of thumb should be an additional 5 This component is automatically checked during the VVT The sensor is a perishable component and should be replaced periodically CAUTION The oxygen sensor is a sealed device containing a mild acid electrolyte lead Pb and lead acetate Lead and lead acetate are hazardous waste constituents and require proper disposal CAUTION Never use ethylene oxide sterilization or immerse the sensor in any cleaning solution or autoclave 02 VersaMed Vent2o1 Service Manual 4 1 3 Solenoid Valve System The solenoid valve system performs two primary functions It provides positive pressure relief safet
138. using fuses and against over voltage by using transient voltage suppressors TVS The fuses are e AC power supply dual fuse inside the power entry unit VersaMed Vent2o1 Service Manual e External 12V to 15VDC supply input an external fuse 15A 250V Internal 12V battery an internal fuse in the battery pack 15A 250V TVS devices are provided on the VSUM power bus and on the 5V and 12V supplies The use of diodes prevents damage resulting from polarity reversal of the sources 4 2 4 4 Battery Charger Block The battery charger is a constant voltage current limited linear regulator The input is VSUM and the output is a constant 13 8V voltage limited to 1 14 maximum current The charger can be disabled under software control 4 2 4 5 5V Output DC DC Converter The 5V power for the CPU and main board is achieved by using a switching regulator that converts the voltage on VSUM 10 to 14 Volts to a regulated 5V The layout is provided for either a 3 amp or 5 amp supply depending on an alternate assembly 4 2 4 6 Power On Off Switching The main power switch on the back panel is a two position switch which is operated by the user The on off logic is redundant so that if any device fails the system does not inadvertently switch off The hard switch directly pulls the 5V enable input low to switch on the system Releasing the hard switch disables the 5V converter A bit is also provided for the software to recogn
139. utlined in steps 1 9 of Section 7 4 Perform steps 1 9 only since the LCD cable does not need to be detached for this service 2 Disconnect the tube from the top of the outlet port to provide clearance Disconnect the gray cable from the top of the existing O sensor Remove the existing O sensor and o ring by turning it counter clockwise The translucent adapter and o ring that connects the O sensor to the pneumatic unit may also come off If it does unscrew the O sensor and reinstall the adapter and o ring to the pneumatic unit 7 4 10 3 0 Sensor Installation 1 Install the replacement sensor and o ring by screwing it into the translucent adapter 2 Reconnect the cable to the O sensor Reinstall the blower sensor tubing to the barbed connector on top of the outlet port 4 Assemble the ventilator enclosure as outlined in Section 7 4 3 3 page 117 Issued 15 Aug 05 135 Perform steps 6 12 only if the LCD cable was not detached 7 5 Battery Gas Gauge Initialization Procedure Whenever the internal battery has been replaced or the gas gauge has accumulated significant error the gas gauge needs to measure the total battery capacity in order to provide meaningful information see Section 4 5 1 page 72 7 5 1 Purpose The purpose of this procedure is to set the gas gauge to accord properly with initial internal battery measurements 7 5 2 Scope This procedure applies to Vent2o
140. ve the unit analyzed repaired and recertified 4 2 1 9 Operating System OS The operating system is pSOS pSOS stands for plug in Silicon Operating System This real time operating system RTOS later evolved to pSOS It is an optimal environment for embedded systems 4 2 2 Main Board Essentially the main board is what makes the Vent201 a ventilator instead of a PC The main board contains all of the sensing control and interface functions required to operate the ventilator except for the power Issued 15 Aug 05 61 interfaces and the motor driver which are controlled by the switching board The main board is the primary interface between the CPU board and the ventilator pneumatic system It has the following primary interface functions Sensors Interface Digital Analog Interface Control and Status Motor Interface Bus Interface Solenoids Interface Stepper Interface Watchdog Timer Remote Alarm SpO 4 2 2 1 Sensors Interface The sensor interface amplifies and filters the low level signals from the sensors for sampling by the analog to digital converter ADC The following sensors are interfaced Flow Sensor Pressure Sensors Oxygen Sensor Temperature Sensor Battery Voltage 4 2 2 1 1 Flow Sensor The flow sensor in the system presents a low flow and a high flow signal for measurement A differential pressure applied to the flow transducer is converted to a low level voltage by the press
141. very component or subsystem discussed in this manual Is accessible or repairable in the field The Vent gt o was designed to provide easy access to serviceable areas of the ventilator Whenever possible this manual describes the practical hands on aspect of a component or system Issued 15 Aug 05 18 1 2 General Description The iVentz is a portable computer controlled electrically powered ventilator providing continuous or intermittent ventilatory support to patients requiring mechanical ventilation as prescribed by an attending physician The Ventoo1 features advanced software electronic and mechanical technologies which along with easy operation provide effective and reliable ventilation Air Inlet Filter ae eg LCD Display LED Indicators Keypad Ventilator Outlet Rotational Control Sensor Lines Connectors m E opeaker Exhalation Valve Control Line Connector Patient Circuit Figure 1 1 The iVentzo front view Issued 15 Aug 05 19 Carrying Handle Keyboard Connector Cooling Fan Outlet Vents Remote Alarm Connector Ground Post External Display DC Power Cord Connector Connector TT145AL 250V opO Probe Connector Optional b IN High Pressure EN ACM 110240V 5060H 1 64 MM M ee VersaMed Medical Systeme L omm T E O Connector AC Power Cord ap Ld Connector Power Switch Internal Battery gt a Pow
142. ware as a function of the power supply or the battery voltage When a serious system failure is detected the solenoids are disabled either by the watchdog or by the software Status bits indicate the voltage of the solenoid which are used to detect a malfunction 4 2 2 7 Stepper Interface Setting bits in a register accesses the stepper interface which sends control signals to a driver device The stepper can be advanced clockwise or counter clockwise in full or half steps and the driver enabled or switched off An indication of the voltage on the stepper coils is available at the stepper status register 4 2 2 8 Watchdog Timer A watchdog timer monitors that the software is active If software input is not toggled every 1 6 seconds the watchdog disables the solenoids and the motor and activates an alarm The watchdog also generates a clean reset pulse and indicates when the analog 5V supply is below normal 4 2 2 9 Remote Alarm The remote alarm output provides a means of sending the ventilator alarm signal to a remotely located central nurse call station or remote alarm Issued 15 Aug 05 65 There are two types of remote alarm schemes and connecting accessories depending upon the type of connector present If the ventilator has a female 4 pin RJ11 modular handset connector a VersaMed supplied interface box is required When ordering the output type must be specified The Interface Box is used to change the open collecto
143. y valve and helps to create the desired pressure waveform The solenoid valve system includes two identical solenoids with different size conical valves plungers and springs The solenoid valves are normally closed so that the air under pressure is delivered to the patient during the inhale phase When open the solenoid system short circuits the blower and helps to achieve a fast pressure drop The solenoid valves open and close a pneumatic path between the blower outlet and inlet Additionally each solenoid valve is a different diameter and can be controlled separately Solenoid 1 has a large diameter and solenoid 2 has a small diameter There are four possible combinations of solenoid valves states both closed both open only the large valve open and only the small valve open Manipulation of these valves along with turbine speed can produce a wide variety of pneumatic waveforms The desired waveform is created under software control The valves are opened at the beginning of every exhale in order to obtain a quick pressure drop to the PEEP level The control over the two solenoids also allows for the Easy Exhale feature during which the pressure is reduced to a level below PEEP for a short time at the beginning of each exhale Both valves are spring loaded to the normally closed position and will begin to open at a nominal pressure of 80 cmH20O This provides the over pressure relief function The safety pressure level i

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