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BIO-MED DEVICES Crossvent-2i+ Operation & Service Manual Download Page 12

I .  

P A T I E N T   S A F E T Y -   C O N T .  

 

7

 

SYMBOLS 

 

Follow Instructions for Use 

 

Product should be kept dry 

 

MR Unsafe 

 

Type BF Equipment 

 

Manufacturer 

 

Date of Manufacture 

 

Country of Origin & Manufacture 

 

Direct Current (DC) 

 

It is essential that these instructions be read and complied with prior to operating this product. 

 

Must be disposed of in accordance with WEEE Directive. 

At the unit’s “end of life”, it may be returned to the manufacturer for proper reclamation. 

 

 

Do not rotate the power supply plug when it is engaged with the jack. 

 

Alarm Reset Switch 

 

Power On/Off Switch 

 

Power On 

 

Power Off/Valve Closed 

 

Valve Open 

Summary of Contents for Crossvent-2i+

Page 1: ...TRANSPORT VENTILATOR OPERATION SERVICE MANUAL CATALOG 2204iC Revision 102621 Bio Med Devices Inc 61 Soundview Road Guilford CT 06437 800 224 6633 FAX 203 458 0440 Web Site www biomeddevices com COPYRI...

Page 2: ...ARM RESET SWITCH 12 2 REAR OF VENTILATOR 13 GAS SUPPLY INLET 13 EXTERNAL ELECTRICAL SUPPLY CONNECTOR 13 BATTERY 13 PATIENT OUTLET 14 EXHALATION VALVE CONNECTOR 14 AIRWAY PRESSURE CONNECTOR 14 PNEUMOTA...

Page 3: ...EFERENCE 29 5 LANGUAGES 29 6 VER Version 29 7 SN Serial Number 29 B CALIBRATION MENU CAL 30 C OPERATIONAL TROUBLESHOOTING 31 VI CLEANING STERILIZATION AND PACKING 33 A CLEANING AND STERILIZATION 33 B...

Page 4: ...L VOLUME 47 ALARM MENUS 48 FLOW TRIGGER 48 CONSTANT FLOW MODE 48 SIMV BACKUP RATE 48 PRESSURE SUPPORT 48 MANUAL 48 C RECOMMENDED TOOLS AND TEST EQUIPMENT 49 1 Special Tools and Test Equipment 49 D PRE...

Page 5: ...BBREVIATIONS 81 APPENDIX B 82 DEFAULT SETTINGS 82 APPENDIX C 83 SUMMARY OF DISABLED FUNCTIONS 83 APPENDIX D 84 AUDIBLE ALARM CODES 84 APPENDIX E 84 CHARGERS AND INVERTERS 84 APPENDIX F 86 EMC Compatib...

Page 6: ...he POWER SOURCE window On a fully charged battery there will be approximately 2 hours of autonomous operation No further alarm will be sounded until the battery is low It is imperative to restore AC p...

Page 7: ...note that once a sensor has been turned off the alarms for that sensor are inoperative Breathing through the negative pressure relief valve requires a greatly increased work of breathing and only air...

Page 8: ...er decay The pneumotach must be in the circuit and connected to the ventilator when using Flow Triggering If the pneumotach is not being used then Constant Flow should be the ventilator mode Without t...

Page 9: ...gas Touch screen control keys should be pressed by hand only Care should be taken not to allow keys to be contacted by sharp objects as damage may result Clean touch screen only with alcohol Clean the...

Page 10: ...ssure Support is only active during SIMV and CPAP with Constant Flow off It is disabled when in Assist Control The wall plug in power supply is furnished for 117 vac 60 hz or 220 vac 50 hz operation a...

Page 11: ...nsumed and does not calibrate properly it should be discarded and a new sensor installed and calibrated Exhaled minute volume indicates a projected or anticipated minute volume based on the current ex...

Page 12: ...urrent DC It is essential that these instructions be read and complied with prior to operating this product Must be disposed of in accordance with WEEE Directive At the unit s end of life it may be re...

Page 13: ...I P A T I E N T S A F E T Y C O N T 8 Rx Only Caution Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner Medical Device Unique Device Identifier...

Page 14: ...pment Prior to using the Crossvent charge the unit until the green charging indicator stops blinking and remains solidly lit Refer to the performance checks in the service section prior to placing thi...

Page 15: ...ggering An absolute pressure transducer monitors atmospheric pressure and automatically compensates for altitude changes The Crossvent 2i has an internal battery that provides power during transport a...

Page 16: ...1 1 Readings below 10 ml may beconsidered relativeratherthan absolute values 2 NOTE All values are expressed under ATPD conditions ambient temperature pressure dry C ADDITIONAL SPECIFICATIONS Base Flo...

Page 17: ...bar graph or with the PEEP CPAP readout on the secondary alarm menu NOTE The PIP should always be set higher than PEEP in order to achieve the PEEP setting NOTE To conserve gas the PIP and PEEP contro...

Page 18: ...as listed in Section III Part B CAUTION When it is necessary to operate the Crossvent from an AC inverter only inverters in compliance with NEMA standards should be used see Appendix E B AT T ERY The...

Page 19: ...expiration it provides a zero or PEEP level to the exhalation valve diaphragm A I RW AY PR E SS U RE C O N N EC T OR Provides connection of the proximal airway pressure tube to the internal pressure t...

Page 20: ...H2O WARNING IT SHOULD NEVER BE OBSTRUCTED N E G A TI VE P RE S SU R E RE L I E F VA LVE A preset negative pressure valve also exits the rear of the unit It allows the patient to breathe ambient air if...

Page 21: ...ows the user to move between menus as well as lock the display and quiet the alarms The bottom row provides information on what type of breath is being delivered power conditions as well as allowing f...

Page 22: ...sist Control key changes to CMV and the SIMV key is eliminated If the unit is in SIMV mode when Constant Flow is pressed it will shift to CMV mode and the SIMV RATE key changes to RATE The Rate key wi...

Page 23: ...s been pressed Press the Setup key and then press TV INSP The currently preferred parameter Tidal Volume in this case will be highlighted Press INSP TIME if you want to set an inspiratory time rather...

Page 24: ...alarm menu and flashes the alarm parameter that is out of limit If more than one alarm sounds simultaneously they each flash If alarms occur in more than one menu the menus are prioritized The CROSSV...

Page 25: ...NG 2 SHORT VENTILATOR FAILURE SOLENOID D3 2 LONG 3 SHORT VENTILATOR FAILURE SOLENOID E2 2 LONG 4 SHORT VENTILATOR FAILURE PNEUMOTACH TRANSDUCER 1 LONG ___ NOTE For a full list of beeper codes see Appe...

Page 26: ...OMMON TO ALL MENUS L O C K Locks all keys except ALARM QUIET and the MENU keys making them inactive if pressed When active this key is highlighted and the touchscreen is locked To unlock it press this...

Page 27: ...y until full charge is reached Whenever the CROSSVENT is powered on without external power the Power Source key will alarm alerting the user the unit is operating on battery power This alarm will cont...

Page 28: ...E C I F I C A T I O N S C O N N E C T I O N S A N D U S E R I N T E R F A C E C O N T 23 CALIBRATION This menu is accessed from the SETUP menu It is reserved for maintenance procedures for service pe...

Page 29: ...thing circuits 1 PATIENT CIRCUIT CONNECTIONS The breathing circuit for the CV2i is BMD catalog 2030 If the isolette does not have an Oxygen Sensor tee built in then 2030 O may be used which has a tee...

Page 30: ...the receiver connect the equipment into an outlet on a circuit different from that to which the receiver is connected or consult the dealer or an experienced radio TV technician for help WARNINGS ONL...

Page 31: ...s Press the AUTO SET key It is necessary to press this key twice within 5 seconds in order to activate the auto limit function This initiates the automatic computation of high and low limits for all p...

Page 32: ...n this sensor is off it may be disconnected while the ventilator is in use without causing an alarm 3 SUMMARY OF OPERATING INSTRUCTIONS Turn on Select mode Set primary functions in MAIN Menu Press AUT...

Page 33: ...g circuit with a test lung to the tee 4 With the O2 sensor cable still plugged into the ventilator install the O2 sensor into the tee 5 Apply 100 oxygen to the ventilator input and set 15 cmH2O of PEE...

Page 34: ...hin 20 of the set TV of 20 16 24 ml Example 11 61 ml 9 50 ml 21 11 ml 4 TV INSP PREFERENCE Allows the user to choose between setting Inspiratory Time or Tidal Volume in the Main Menu when not using Co...

Page 35: ...he CROSSVENT Ventilator Refer to the MAINTENANCE SERVICE SECTION of this manual under Setup Calibration Menu Overview for explanations of functions contained in this menu WARNING Only qualified traine...

Page 36: ...ncontrolled auto cycle remains in inspiratory mode 1 Flow Trigger setting is too sensitive 2 Pressure transducer malfunction 1 Increase Flow Trigger setting 2 Submit for service Peak pressure high lim...

Page 37: ...fferential pressure transducer 1 Reconnect the pneumotach and or tubes 2 Service needed Incorrect tidal volume reading 1 Incorrect flow calibration 2 Blocked or kinked pneumotach tubes 3 Leak in patie...

Page 38: ...h Screen Keypad The touch screen of the Crossvent 2i is made of transparent plastic and may be damaged by chemical solvents and abrasive cleaners Use only alcohol when cleaning this area Great care sh...

Page 39: ...with the unit must also be returned as outlined here Procedure 1 Cover CROSSVENT with the poly bag and secure with twist tie or tape 2 Wrap the CROSSVENT in the foam or bubble wrap with at least 2 inc...

Page 40: ...35 MAINTENANCE AND SERVICE SECTION...

Page 41: ...ntire system becomes inoperative During the period of time when valve A is open and gas flows solenoid valve B is actuated allowing gas from the PIP valve to pressurize the diaphragm of the exhalation...

Page 42: ...his small difference in pressure The signal from the transducer is then converted by the microprocessor into a measurement of exhaled tidal volume and minute volume This transducer is also used to sen...

Page 43: ...ting Inspiration may be initiated by either a patient inspiratory effort or in the absence of that the backup setting At the start of inspiration gas flows to the patient at the flow rate established...

Page 44: ...dal volume than that which is set he need only continue to inhale As long as pressure below baseline zero or PEEP is detected the ventilator will continue to deliver boluses of gas as determined by th...

Page 45: ...th additional boluses available with continued effort until the patient is satisfied Whatever gas is not inspired by the patient is vented to atmosphere Pressure Support See SIMV above When Constant F...

Page 46: ...lso the backup rate When in CPAP mode the backup rate is set with the Backup Rate key In the event of apnea the ventilator will deliver control breaths at this rate WARNING IT IS IMPORTANT TO ALWAYS S...

Page 47: ...nu or any menu accessed from this menu is displayed It is possible to go to the CALIBRATION menu by pressing the CAL MENU key or to return to normal operation at any time by pressing the MAIN MENU key...

Page 48: ...splayed here is compared with the actual flow being delivered as measured by a test instrument Refer to the Pneumatic Calibration section later in this manual for detailed instructions T O U C HS CR E...

Page 49: ...ey will change its state from OFF to ON or vice versa Only three valves may be on simultaneously H O U R S Indicates the total accumulated hours the ventilator has been powered on F A CT O RY S ERV I...

Page 50: ...he integrity of the patient circuit and its connections Connect the patient circuit along with a test lung to the Crossvent Set the PIP to its maximum setting Set the flow control to 10 LPM Press ente...

Page 51: ...on the circuit while observing the test instrument reading It should indicate between 64 and 96 cmH2O Increase the flow until it is at its maximum setting The pressure should not exceed 96 cmH2O 3 MAI...

Page 52: ...s for 120 sec Press it a third time to cancel B AC K L I G HT While operating on battery press the middle of Pressure Bar Graph hold until a second beep is heard 3 seconds and verify that the BACKLIGH...

Page 53: ...the level again and repeat It should require slightly more effort this time to make the unit cycle C O N S TA NT F L O W M O D E Turn on Constant Flow Mode and verify flow remains ON Turn OFF when do...

Page 54: ...Anti Static mat ground cable assembly Anti Static Mat Workbench cover Anti Static Strap Wrist Strap Digital Voltmeter Fluke 85 or Equivalent Syringe and tee 25 or 50 ml with 170 barb tee DC Power Sup...

Page 55: ...allow it to cool and check again If there is no voltage and it won t take a charge but the charging circuit is good replace the battery The battery should be checked before each use To check Turn on t...

Page 56: ...e by qualified personnel as the rear panel of the ventilator must be removed to access the RS232 jack used to download the software When requesting new software the serial number of the Crossvent is r...

Page 57: ...P Valve 132 Proximal Flush Variable Resistor 10 D A R V Diaphragm Actuated Relief Valve 131 PEEP Variable Resistor 128 2 Way Pressure Relief Valve 153 Base Flow Resistor 22 PIP Valve 154 Auxiliary Reg...

Page 58: ...ification it should be replaced IF IT FAILS THE ABOVE TEST CALIBRATE AS FOLLOWS d Clamp off the blue PEEP line between the small cross fitting and the white bleed manifold mounted to the top of the D...

Page 59: ...do not force the valve If abnormal resistance is felt prior to the valve closing to within this specification it should be replaced NOTE In the zero position the valve gear should be flush with the en...

Page 60: ...17 1 psi IF IT FAILS THE ABOVE TEST CALIBRATE AS FOLLOWS c Set up the same as steps a b d Adjust the pressure to 16 18 psi by turning the hex screw in the top of the regulator 8 PEEP SIGNAL 10 cmH2O p...

Page 61: ...LIEF VALVE 96 cmH2O perform first 5 6 TO TEST a Connect the Patient Connector on the back of the CV 2i to a low pressure test instrument using a single length of tubing b Occlude the opening of the D...

Page 62: ...If it is not within the 10 limits press the 2 in the table on the display The displayed flow on the Crossvent should now display 2 lpm The flow knob is now calibrated to the actual flow for that setti...

Page 63: ...h Bio Med Devices part PRT2268 Do not substitute NOTE After installing a new battery it must be discharged the battery gauge must be reset in the calibration menu and the battery then fully charged an...

Page 64: ...e bezel as it is removed The power switch and reset switch will remain with the unit Watch the button on the reset switch which may fall off 5 To re install make sure the RFI conductive gaskets are in...

Page 65: ...ide of the case and remove the assembly from the studs 7 The pneumatics are now free from the case and may be removed 8 Reassemble in the reverse order 7 PNEUMATIC VALVE BRACKET ASSEMBLY 1 Remove rear...

Page 66: ...h Remove the gear l Rotate the Flow Valve shaft 180 CCW from the closed position m Position the gear on the shaft so that the setscrews are at the top approximately 11 1 o clock positions and secure t...

Page 67: ...ced they will need to be calibrated Refer to the Pneumatic Calibration Procedures for these instructions 3 The process for removal and replacement is the same for each line as described here a Observe...

Page 68: ...charged D103 or DC103 open Charge battery Replace D103 or DC103 External power failure alarm BATT flashing Loss of external power AC adaptor defective Fuse F101 open Defective D101 D104 DC101 Check in...

Page 69: ...e too low PIP not on or defective Flow restriction or leak Input filter clogged Regulator set too low Flow valve defective Check supply pressure at ventilator input fitting while gas is flowing Should...

Page 70: ...SINGLE SUPPLY INLET 6 PRT2268 ASSY BATTERY 7 2V 6 C CELL NiMH Do not substitute 13 PRT3316 ASSY LCD DISPLAY WITH TOUCHSCREEN 14 PRT4410 LED ALARM 16 PRT2266 PC BOARD NO DISPLAY INCL D 17 PRT2267 PC B...

Page 71: ...PICAL SOLENOID ARROW NOT INDICATIVE OF DIRECTION OF FLOW ATM ATMOSPHERE SOLENOID VALVE SOLENOID VALVE TO A SOLENOID PATIENT OUTPUT MANIFOLD FROM SOLENOID E2 ATM PEEP PIP SOLENOID VALVE BASE FLOW TO PA...

Page 72: ...OID BASE FLOW TO PATIENT OUTPUT MANIFOLD MICROPROCESSOR CONTROL CIRCUITRY SOLENOID VALVE SOLENOID VALVE SOLENOID VALVE SOLENOID VALVE SOLENOID VALVE PILOT VALVE CHECK VALVE 2 WAY RELIEF VALVE FLOW VAL...

Page 73: ...TIOMETER JPOT TD AIRWAY TD PNEUMO TD ATMOS JSOL JPOWER JCON JTS ESD 02 JACK ALARM LED B A C K L I G H T SOLENOID PCB JSOL BATTERY ALTITUDE TRANSDUCER AIRWAY PRESSURE TRANSDUCER PNEUMOTACH TRANSDUCER J...

Page 74: ...IX P A R T S L I S T A N D S C H E M A T I C D I A G R A M S C O N T 69 3 CIRCUIT SCHEMATICS GROUND TEST POINTS POWER SUPPLY Main PCB schematic page 1 of 6...

Page 75: ...IX P A R T S L I S T A N D S C H E M A T I C D I A G R A M S C O N T 70 BATTERY CHARGER Main PCB schematic page 2 of 6...

Page 76: ...IX P A R T S L I S T A N D S C H E M A T I C D I A G R A M S C O N T 71 MAIN PROCESSOR Main PCB schematic page 3 of 6...

Page 77: ...IX P A R T S L I S T A N D S C H E M A T I C D I A G R A M S C O N T 72 DISPLAY TOUCHSCREEN Main PCB schematic page 4 of 6...

Page 78: ...IX P A R T S L I S T A N D S C H E M A T I C D I A G R A M S C O N T 73 ALARM PROCESSOR Main PCB schematic page 5 of 6...

Page 79: ...IX P A R T S L I S T A N D S C H E M A T I C D I A G R A M S C O N T 74 TRANSDUCERS Main PCB schematic page 6 of 6...

Page 80: ...IX P A R T S L I S T A N D S C H E M A T I C D I A G R A M S C O N T 75...

Page 81: ...r Jack as seen from rear of adaptor MODULAR TO DB9 ADAPTOR MODULAR CABLE View of Modular Jack as seen from rear of Crossvent JCON ON MAIN PCB ADAPTOR WIRING RESIN and RESOUT shorted at modular end DTR...

Page 82: ...IX P A R T S L I S T A N D S C H E M A T I C D I A G R A M S C O N T 77 MAIN COMPONENT LOCATIONS...

Page 83: ...IX P A R T S L I S T A N D S C H E M A T I C D I A G R A M S C O N T 78 SOLENOID COMPONENT LOCATIONS...

Page 84: ...IX P A R T S L I S T A N D S C H E M A T I C D I A G R A M S C O N T 79 RS232 CONNECTOR PCB...

Page 85: ...S INC will pay any shipping charges required in repairing or replacing any part or all of this Ventilator within three 3 months from the date of purchase Thereafter shipping charges will be paid by th...

Page 86: ...iratory Pressure CPAP Continuous Positive Airway Pressure SIMV Synchronized Intermittent Mandatory Ventilation IMV Intermittent Mandatory Ventilation DISS Diameter Index Safety System I E Inspiratory...

Page 87: ...est routine is performed Mode Assist Control Rate 12 bpm Tidal Volume 100ml Flow Trigger 3 SIMV rate 4 bpm Pressure support off Alarm limits Peak low 29 Peak high 30 Rate low 78 Rate high 79 ExhMV low...

Page 88: ...CPAP MODE MAIN RATE DISABL CF CPAP EXP TIME NONE REMOVED FROM DISPLAY I E RATIO NONE REMOVED FROM DISPLAY AUTO SET NONE KEY IS INACTIVE FLOW TRIGGER OFF PRESSURE SUPPORT DISABL BY CF ALARM 1 RATE ALA...

Page 89: ...run the Crossvent or to charge the batteries only the Jerome Industries model WSZ116M 16VDC 3A charger supplied by Bio Med Devices should be used The Bio Med charger has been thoroughly tested for pr...

Page 90: ...appropriate fusing This will keep extraneous interference and current leakage to a minimum 3 INVERTER OPERATION If it is necessary to operate the Crossvent from an AC inverter similar to KGS Electroni...

Page 91: ...t be installed and put into service according to the EMC information provided in the following documentation 3 Cables Accessories or Transducers Use of accessories transducers and cables other than th...

Page 92: ...vent is intended for use in the electromagnetic environment specified below The customer or the user of the Crossvent should assure that it is used in such an environment Immunitytest Compliancelevel...

Page 93: ...icEnvironment Guidance Conducted RF IEC 61000 4 6 Radiated RF IEC 61000 4 3 6 V rms i 10 V m The Crossvent is suitable for the electromagnetic environment of typical commercial or hospital settings Th...

Page 94: ...in its entirety and follow their own facility s training guidelines for new equipment Bio Med Devices also recommends the use of the further training resources including in service videos available at...

Page 95: ...bly Hazards for service or EOL device disposal Once the front bezel is removed the copper finger strips installed around the edges of the front bezel can cut fingers and hands when handling the assemb...

Page 96: ...Disassembly 55 Display Test 40 Expiratory 17 External Power 10 12 Factory Service 41 Filter 34 47 Filter Replacement 58 Flow 11 15 17 Flow Calibration 42 53 Flow Trigger 16 Flush 33 Gas Supply 4 12 H...

Page 97: ...16 17 36 SIMV Rate 17 36 Software Upgrade 48 Specifications 10 Spontaneous SPONT 21 Spontaneous Breaths 16 Temperature 10 Theory of Operation 33 Tidal Volume 17 26 Touch Screen 30 Touchscreen Calibra...

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