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BIO-MED DEVICES 2005IC, Инструкция по эксплуатации

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11

I.  GENERAL 

 

A.  INTENDED USE 

 

The Model IC-2A Ventilator is for respiratory support of adult patients both in 
hospital and during transport.  It may be used either volume or pressure limited and 
with a wide range or I\E ratios less than or greater that 1:1. 
 

WARNING

: Do not use in a MRI room unless the IC-2A has been built by Bio-Med 

Devices for such an environment. This will be indicated by a MRI plaque on the top 
of the unit and a “M” at the end of the serial NUMBER.

 

 
B.  MODES OF OPERATION 

 

It is a pulsatile flow Ventilator which may be used in any of the following operating 
modes: 

 

• 

Time cycled, either volume or pressure limited, with or without 
Positive End Expiratory Pressure (PEEP). 

• 

Intermittent Positive Pressure Ventilation (IPPV) 

• 

Synchronized Intermittent Mandatory Ventilation (SIMV) 

• 

Continuous Positive Airway Pressure (CPAP). 

• 

Manual 

 

C.  FEATURES 

 

Portable:  Compact and light weight.  May be hand carried or attached to stand; 
used without interruption during transportation; compatible with masks, 
endotracheal tubes and tracheostomy tubes. 

 

Gas Powered:  Portable pressurized tank or wall outlet, providing 50 psi oxygen or 
air. 

 

Operable in Hazardous Areas:  Non-electric, no shock hazard, case constantly self-
purged. 

 

High Reliability:  Controlled by miniature pneumatic logic elements; with negligible 
frictional wear. 

 

Very low compliance. 

 

Readily usable with standard accessories: humidifier, oxygen blender, oxygen 
analyzer, pressure alarms, and patient circuit. 

 

D.  PERFORMANCE CHARACTERISTICS 

 

Direct control is provided for inspiratory and expiratory times, flow rate, and 
maximum pressure and PEEP or CPAP levels within the patient circuit. 

 

Содержание 2005IC

Страница 1: ...DEVICES IC 2A ADULT INTENSIVE CARE VENTILATOR INSTRUCTION MANUAL CATALOG 8050A PRICE 25 00 REV 122606 BIO MED DEVICES INC 61 SOUNDVIEW ROAD GUILFORD CT 06437 203 458 0202 Fax 203 458 0440 www biomeddevices com ...

Страница 2: ...A EQUIPMENT REQUIRED 18 B SUPPLY GAS 18 C MOUNTING BRACKET 18 D ANCILLARY EQUIPMENT 18 IV SET UP 20 A CONNECTION OF GAS SUPPLY 20 B CONNECTION OF PATIENT CIRCUIT 20 V SELECTION OF VENTILATION PARAMETERS AND ADJUSTMENT OF CONTROLS 21 A INTERMITTENT POSITIVE PRESSURE VENTILATION IPPV WITH OR WITHOUT PEEP 21 B SYNCHRONIZED INTERMITTENT MANDATORY VENTILATION SIMV 22 C CONTINUOUS POSITIVE AIRWAY PRESSU...

Страница 3: ...ERS REGULATORS MOUNTING BRACKETS AND SUPPORT STANDS THAT ARE MADE OF ANY METAL THAT COULD BE ATTRACTED BY A MAGNET SYMBOL EXPLANATION Attention See Instructions for Use Date of Manufacture SN Serial Number REF Catalog Number The CE mark displayed on this product signifies that this device is in compliance with the European Medical Devices Directive Council Directive 93 42 EEC As a prerequisite for...

Страница 4: ...ut coupler D blender primary outlet to IC 2A patient supply 2 Connect the air supply hose 1011 to the air supply fitting on the blender 3 Connect the elbow fitting B to the leg of the high pressure wye A and the other side of the elbow to the logic supply fitting on the IC 2A 4 Using the coupler C connect the other leg of the high pressure wye to the O2 supply fitting on the blender 5 Connect the ...

Страница 5: ... regulator in the cylinder bracket to the left and with the supply output fitting facing to the rear If using Bio Med s Deluxe Regulator then the 50 psi out fitting should face forward Use the elbows 3 in the following locations Face the threads as indicated Logic supply input on the IC 2A face threads to the rear Patient supply input on the IC 2A face threads to the rear Blender output face threa...

Страница 6: ...supply input on the IC 2A Blender output The enclosed high pressure wye is to be used to split the oxygen source before the blender so one leg goes to the blender input and the other to the IC 2A logic input Connect the 10 oxygen supply hose to the input of the wye Connect the short hose leg of the wye to the blender oxygen input Connect the long hose leg of the wye to the elbow on the IC 2A logic...

Страница 7: ...5 ...

Страница 8: ...8001A or 8001AM QTY CAT DESCRIPTION 1 CCAP005 CAP ON IC 2A PATIENT OUTLET 1 2013 MOUNTING BRACKET 1 8005 HIGH PRESSURE WYE 2 PFIT143 SUPPLY ELBOW ADAPTERS 1 1010 10 HIGH PRESSURE O2 SUPPLY HOSE 1 1020 ADULT TEST LUNG 2 8002A DISPOSABLE PATIENT CIRCUIT 1 8050A IC 2A INSTRUCTION MANUAL 1 WARRANTY CARD For IC 2A Complete Package Catalog 8001AMBC QTY CAT DESCRIPTION 1 8001AM IC 2A MRI VENTILATOR 1 CCA...

Страница 9: ...KIT INCLUDES THE FOLLOWING QTY CAT DESCRIPTION 2 PFIT143 SUPPLY ELBOW ADAPTERS 1 8005BH HIGH PRESSURE WYE FOR BLENDER ON STAND 2 1010 2 2 OXYGEN SUPPLY HOSE 1 1010 10 OXYGEN SUPPLY HOSE 1 1011 2 2 AIR SUPPLY HOSE 1 1011 10 AIR SUPPLY HOSE 1 2013BH BLENDER BRACKET FOR HEAVY DUTY STAND ...

Страница 10: ... Nor does the warranty cover abuse or misuse of the instrument or damage due to unauthorized servicing If service is required the instrument must be properly packed and shipped pre paid directly or through your dealer to BIO MED DEVICES INC 61 SOUNDVIEW ROAD GUILFORD CT 06437 203 458 0202 An explanation of the problem should accompany the equipment Please include your name and telephone number wit...

Страница 11: ...UMBER If the ventilator is to be used unattended or without remote monitoring a high low pressure alarm must be used at all times with the user within visual and or audible range of this alarm Recommended monitors for this purpose are Bio Med Devices M 1 or M 10 Any HUMIDIFIER used with the IC 2A must be a flow through type having a low pressure drop Use of a humidifier with a bubbler tube or pres...

Страница 12: ...ng to patient to avoid erroneous breaths Whenever the IC 2A is turned off disconnect the patient before turning the ventilator back on in order to avoid erroneous breaths Antistatic or electrically conductive hoses or tubing should not be used ...

Страница 13: ...ssure Ventilation IPPV Synchronized Intermittent Mandatory Ventilation SIMV Continuous Positive Airway Pressure CPAP Manual C FEATURES Portable Compact and light weight May be hand carried or attached to stand used without interruption during transportation compatible with masks endotracheal tubes and tracheostomy tubes Gas Powered Portable pressurized tank or wall outlet providing 50 psi oxygen o...

Страница 14: ...dically with an oxygen analyzer The tidal volume when the ventilator is operated in a volume limited mode is the product of flow rate converted to ml sec and inspiratory time TIDAL VOLUME ml FLOW RATE ml sec X INSPIRATORY TIME sec NOTE Flow rate is not Minute Volume MINUTE VOLUME TIDAL VOLUME X RESPIRATORY RATE It should be noted that the MAX PRESSURE and PEEP CPAP control settings are affected sl...

Страница 15: ... limit is normally set 5 10 cmH2O above the pressure attained It then acts as an upper level failsafe If patient resistance or compliance cause a significant increase in pressure the pressure will be limited at the preset level When this occurs the ventilator is no longer volume limited since some gas is dumped to atmosphere and therefore the tidal volume is unknown b Pressure Limited Whenever the...

Страница 16: ...ll being generated following the termination of the inspiratory period another inspiratory period and as many more as necessary will be initiated thus providing as much gas as required The patient may exhale at any time during spontaneous breathing since the exhalation valve is not pressurized It is however desirable to set the flow rate and inspiratory time to give a tidal volume as close to the ...

Страница 17: ...ing with chest compressions for cardiopulmonary resuscitation The manual button is inoperative until the CYCLE CPAP MANUAL selector is switched to the CPAP MANUAL position The inspiration time is set with the inspiratory time control The manual button should be depressed long enough on each cycle to set the inspiratory timer and then released The inspiratory period will then last as long as the ti...

Страница 18: ...ators a Pressure Gauge Indicates proximal airway pressure Calibrated from 20 to 120 cmH2O b Cycle Indicator Indicates any time cycled inspiratory period c Demand Indicator Indicates any cycle initiated by patient breathing effort or backup timer 3 Connections a Logic Power Supply 100 O2 A DISS oxygen fitting for connection to source of clean dry 50 5 psi 345 34 5 kPa oxygen to power logic b Patien...

Страница 19: ...art 8002A Pressure Gauge 10 to 120 cmH2O 3 full scale accuracy Failsafe Two Way Relief Valve Installed internally opens at pressures above 120 20 cmH2O or below 4 1 cmH2O PEEP CPAP Range Variable from 0 to 25 5 cmH2O Logic Gas Consumption Approximately 12 LPM Varies with control settings Higher pressure increases consumption Weight 4 1 kg 9 lbs Physical Dimensions 8 57 X 15 56 X 26 04 cm 3 1 8 x 6...

Страница 20: ...CASE SHOULD A SUPPLY PRESSURE LESS THAN 35 PSI 242 kPa OR OVER 80 PSI 552 kPa BE CONNECTED TO THE IC 2A AS IT WILL CAUSE MALFUNCTION OF THE VENTILATOR C MOUNTING BRACKET The supplied mounting bracket may be installed on any column up to 1 5 in diameter D ANCILLARY EQUIPMENT Other standard equipment that may be used with the IC 2A at the option of the user includes Oxygen Blender any oxygen blender...

Страница 21: ... Med Devices M 10 may be connected if desired to simplify use of the ventilator by supplying readout of rate and I E ratio It should be connected in the same way as the high low pressure alarm Spirometer any spirometer may be used to verify the tidal volume administered by the IC 2A NO DEVICE SHOULD EVER BE CONNECTED TO THE EXHALATION VALVE LINE OR MALFUNCTION MAY RESULT ...

Страница 22: ... to the main patient output fitting Connect the other end to the input port of the humidifier 2 Connect the main patient hose corrugated tube to the output connector of the humidifier 3 Attach the exhalation valve line to the exhalation valve fitting 4 Connect the proximal airway pressure line to the pressure gauge fitting 5 Attach patient port of exhalation valve to a test lung BMD Part 1020 Afte...

Страница 23: ...m PEEP CPAP control fully clockwise zero Step 5 adjust insp time and exp time controls to required settings Step 6 set flow rate control to proper position to give desired tidal volume according to Table II Step 7 set desired oxygen concentration with blender control Example Prescribed parameters Tidal Volume 500 ml Respiratory Rate 20 I E Ratio 1 2 From Table I Insp Time 1 0 sec Expiratory Time 2...

Страница 24: ...piration Step 12 If PEEP is to be used set the desired level using the PEEP CPAP control Adjust control until the pressure gauge indicates the desired level during the expiratory time Note that the PEEP level is somewhat sensitive to flow rate The PEEP control should be set with the flow rate used When using PEEP the inspiratory effort control should be reset to compensate for each PEEP level used...

Страница 25: ...isted breath the backup timer is reset The interval between assisted breaths may still be set to the maximum expiratory time of at least 45 seconds In SIMV the demand indicator alone will show spontaneous breaths while both demand and cycle indicators together indicate an assisted breath or a backup breath C CONTINUOUS POSITIVE AIRWAY PRESSURE CPAP NOTE WHENEVER THE IC 2A IS TURNED OFF DISCONNECT ...

Страница 26: ...set NORMAL SIMV selector to SIMV Set expiratory time to maximum Step 3 set desired inspiratory flow rate and inspiratory time Step 4 set maximum pressure level rear panel control by occluding patient port depressing manual control and adjusting maximum pressure Step 5 adjust PEEP level in manner similar to maximum pressure if it is desired to have PEEP during manual cycles Step 6 ventilate test lu...

Страница 27: ...hanges Expiration Valve must be positioned with diaphragm cap white section with pilot hose connection up Exhaust port on bottom should be unimpeded White adapter section on exhaust port of the exhalation valve may be removed to limit the amount of noise produced due to resonance Do not connect any devices such as spirometer alarms monitors etc to exhalation valve line WHEN THE VENTILATOR MUST BE ...

Страница 28: ...r source steps should be taken to filter and dehumidify the room air before introducing it into the IC 2A Do not lean on or place excessive weight on the IC 2A while it is mounted on a bracket since the bracket is designed to support only the IC 2A Moisture or dirt in the IC 2A will cause it to function improperly It is recommended that the BMD patient circuit 8002A be used with the IC 2A The use ...

Страница 29: ...nnect a water supply to these fittings Only clean dry oil free medical grade gas may be used B CHECKOUT PROCEDURE For the following tests the unit will require supply connections of 50 5 PSI 345 34 5 kPa medical grade oxygen an adult patient circuit Bio Med 8002A and a test lung Bio Med 1020 Unless otherwise stated all controls and switches are set as follows Connect 100 02 supply at 50 PSI 345 kP...

Страница 30: ...ould not be less than 100 cm or greater than 130 cm 6 MAXIMUM PRESSURE Set INSPIRATORY TIME to 2 sec Set ON OFF switch to ON Observe the manometer while increasing the flow rate through its entire range The circuit pressure during inspiratory must be 100 cm or greater through entire flow range 7 MAXIMUM PRESSURE ZERO Turn Maximum Pressure knob fully CW Set ON OFF switch to ON Observe the manometer...

Страница 31: ...INSPIRATORY TIME knob in a CCW direction verify that all indicated times are within 10 of panel values 13 EXPIRATORY TIMES Set up as in 12 While turning the EXPIRATORY TIME knob in a CCW direction verify that all indicated times are within 10 of panel values While the unit is in inspiratory move the EXPIRATORY TIME knob CW to the full IMV position against the stop For an accurate reading of the ba...

Страница 32: ...ont dial of the gauge If the calibration of any of the indicators or controls is in error then the instrument should be returned to BMD for adjustment D IF SERVICE IS REQUIRED The IC 2A Ventilator should be returned to BMD for any repair or service that may be required Maintenance scheduling of the Bio Med Devices IC 2A Pneumatic Ventilator is dependent upon frequency of use condition of supply ga...

Страница 33: ...1 3 1 1 7 1 2 5 1 3 3 1 52 48 40 34 27 22 75 1 1 9 1 1 5 1 1 1 3 1 2 1 2 7 1 43 40 34 30 24 20 1 00 1 2 5 1 2 1 1 3 1 1 1 5 1 2 1 32 30 27 24 20 17 1 50 1 3 8 1 3 1 2 1 1 5 1 1 1 3 1 25 24 22 20 17 15 2 00 1 5 1 4 1 2 7 1 2 1 1 3 1 1 14 13 13 12 11 10 EXPIRATORY TIME SEC 4 00 1 10 1 8 1 5 3 1 4 1 2 7 1 2 60 RESPIRATORY RATE INSP TIME EXP TIME 60 R TI TE ...

Страница 34: ...20 130 170 250 330 500 670 30 200 250 375 500 750 1000 40 270 330 500 670 1000 1330 50 330 420 630 830 1250 1670 60 400 500 750 1000 1500 2000 70 470 580 875 1170 1750 2330 FLOW RATE LPM 75 500 630 940 1250 1880 2500 TIDAL VOLUME ml INSP TIME X FLOW RATE ml sec VT TI X VI ...

Страница 35: ...3 APPENDIX A EUROPEAN AGENT Bio Med Devices Official Agent in Europe is HORST HÖRNLA H H Intermed Schwedenstraße 32 87463 Dietmannsried Reicholzried United Germany Telefon 08 31 6 31 86 Fax 08 31 6 09 54 ...

Страница 36: ...uss The results of the test were as follows 1 There was no detectable magnetic attraction of the ventilator 2 The operation of the ventilator was not affected 3 There was no effect on the MRI image Although this test was performed within the bore of the MRI unit Bio Med Devices does not recommend the ventilator be placed inside the bore in practice Minimum proximity of one meter should be observed...

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