BIO-MED DEVICES

IC-2A ADULT
INTENSIVE CARE VENTILATOR
INSTRUCTION MANUAL

CATALOG #8050A
REV 042716

BIO-MED DEVICES, INC.

61 SOUNDVIEW ROAD, GUILFORD, CT 06437
(203) 458-0202 Fax (203) 458-0440
www.biomeddevices.com
 TABLE OF CONTENTS
ADDENDUMS ................................................................................................................. 1
MAGNETIC RESONANCE ENVIRONMENT ............................................................... 1
SYMBOL EXPLANATION ............................................................................................ 1
IC-2A WITH TOP MOUNTED BLENDER .................................................................... 3
BLENDER SETUP INSTRUCTIONS WITH HEAVY DUTY STAND ............................ 4
UNPACKING .................................................................................................................. 7
WARRANTY ................................................................................................................... 9
WARNINGS .................................................................................................................. 10
CAUTIONS ................................................................................................................... 10
I. GENERAL ................................................................................................................. 12
A. INTENDED USE................................................................................................... 12
B. MODES OF OPERATION .................................................................................... 12
C. FEATURES .......................................................................................................... 12
D. PERFORMANCE CHARACTERISTICS .............................................................. 12
II. DESCRIPTION ......................................................................................................... 14
A. PRINCIPLES OF OPERATION ............................................................................ 14
B. CONTROLS, INDICATORS AND CONNECTIONS ............................................. 16
C. SPECIFICATIONS ............................................................................................... 18
III. INSTALLATION CONSIDERATIONS ..................................................................... 20
A. EQUIPMENT REQUIRED .................................................................................... 20
B. SUPPLY GAS....................................................................................................... 20
C. MOUNTING BRACKET ........................................................................................ 20
D. ANCILLARY EQUIPMENT ................................................................................... 20
IV. SET UP ................................................................................................................... 22
A. CONNECTION OF GAS SUPPLY........................................................................ 22
B. CONNECTION OF PATIENT CIRCUIT ................................................................ 22
V. SELECTION OF VENTILATION PARAMETERS AND ADJUSTMENT OF
CONTROLS .................................................................................................................. 23
A. INTERMITTENT POSITIVE PRESSURE VENTILATION (IPPV) WITH OR
WITHOUT PEEP ....................................................................................................... 24
B. SYNCHRONIZED INTERMITTENT MANDATORY VENTILATION (SIMV) ......... 25
C. CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) ................................... 26
D. MANUAL CYCLING ............................................................................................. 27
VI. PRECAUTIONS ...................................................................................................... 28
VII. MAINTENANCE ................................................................................................ 3030
A. NORMAL CARE ................................................................................................... 30
B. CHECKOUT PROCEDURE ................................................................................. 30
C. CALIBRATION ..................................................................................................... 33
D. IF SERVICE IS REQUIRED ............................................................................... 333
TABLE I ...................................................................................................................... 344
RATE & I/E RATIO .................................................................................................. 344
TABLE II ..................................................................................................................... 355
TIDAL VOLUME ...................................................................................................... 355
APPENDIX A .............................................................................................................. 366
AUTHORIZED REPRESENTATIVE IN THE EUROPEAN COMMUNITY ............... 366
APPENDIX B .............................................................................................................. 377
IC-2A Ventilator MR Information .............................................................................. 377
ADDENDUMS

MAGNETIC RESONANCE ENVIRONMENT

WARNING: ONLY AN IC-2A ORIGINALLY MANUFACTURED BY BIO-MED DEVICES
FOR MRI USE OR RECEIVING AN MRI CONVERSION BY BIO-MED DEVICES IS TO
BE USED IN AN MR ENVIRONMENT. THESE UNITS WILL BE DESIGNATED BY AN
MRI LABEL AND AN “M” AS A SUFFIX TO THE SERIAL NUMBER.

WHEN USING THE MR-CONDITIONAL IC-2A VENTILATOR IN AN MR

ENVIRONMENT, THE FOLLOWING PRECAUTIONS MUST BE TAKEN:

 THE VENTILATOR MUST NOT BE PLACED INSIDE THE MR BORE (SEE

APPENDIX B).

 DO NOT USE ANY ACCESSORIES, INCLUDING OXYGEN AND AIR

CYLINDERS, REGULATORS, MOUNTING BRACKETS AND SUPPORT
STANDS, THAT ARE MADE OF ANY METAL THAT COULD BE ATTRACTED
BY A MAGNET.

SYMBOL EXPLANATION

MR Conditional

MR Unsafe

Follow Instructions for Use

Caution: Consult accompanying documents

Consult Accompanying Documents / IFU

1
 Product should be kept dry

Warning: Condensed water in air supply can cause malfunction of this

device

Warning: Do not obstruct bleed holes on the back of this device

Rx Caution: Federal law restricts this device to sale by or on the order of a

Only licensed healthcare practitioner

Date of Manufacture

Manufacturer

SN Serial Number

REF Catalog Number

Authorized Representative in the European Community.

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 the CE mark, Bio-Med Devices operates
under an ISO 13485 compliant quality system (covering the design and
manufacture of medical devices). The four-digit code underlying the CE
mark (0086) pertains to Bio-Med's Notified Body, the British Standards
Institute, whose function is to investigate and attest to the validity of CE-
mark claims.

2
IC-2A WITH TOP MOUNTED BLENDER

The following instructions explain how to make the connections between your IC-2A and
blender using the Bio-Med Blender Hose Kit, catalog #2005IC.

1. Mount the blender to the IC-2A using the

nut to nut 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. Use the coupler (C) to connect the other

leg of the high pressure wye to the O2 supply
fitting on the blender.

5. Connect the O2 supply hose (1010) to the

wye.

3
BLENDER SETUP INSTRUCTIONS WITH HEAVY DUTY STAND

Setup instructions for the IC-2A and optional blender using hose kit #2005ICHC

This hose kit is intended for use when cylinders are used with the IC-2A complete
package, Catalog #8001AMBC.

Prior to mounting the pole to the base, slip the cylinder brackets over the end of the
pole. Put the open bracket on first and then the one with the bars across the rings. The
bars should be down (closest to the end of the pole). Install the pole to the base.
Secure the pole to the base with the washer and nut.

Mount the blender bracket (pins down) approximately 12" from the top of the pole.

Place the blender in the bracket.

Place the IC-2A in the top tilt bracket.

Install the oxygen cylinder with regulator in the cylinder bracket to the right and with the
supply output fitting facing forward. If using Bio-Med's Deluxe Regulator, then the 50
PSI Out fitting should face forward.

Install the air cylinder with 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 threads to outside of blender air fitting.

The high pressure wye is to be used to split your oxygen source before the blender so
the short leg goes to the blender input and the long leg goes to the IC-2A logic
input. Connect one end of a 2' oxygen supply hose to the input of this wye and the
other end to the output fitting on the oxygen cylinder regulator.

Connect one end of the 2' air supply hose to the output fitting on the air cylinder
regulator and the other end to the blender air input.

Connect the remaining 2' supply hose from the elbow on the blender output to the IC-2A
patient supply input.

If using Bio-Med's Deluxe Regulators, use the 10' air & oxygen hoses and connect the
50 PSI Input fittings to corresponding wall sources, if desired.

4
Setup instructions for the IC-2A and optional blender using hose kit #2005ICH

This hose kit is intended for use when cylinders are NOT used.

Mount the blender bracket (pins down) approximately 12" from the top of the pole.

Place the blender in the bracket.

Place the IC-2A in the top tilt bracket.

Use the elbows (3) in the following locations. Face the threads to the rear.
Logic supply input on the IC-2A.
Patient 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 supply input.

Connect the 10' air supply hose to the blender air input.

Connect one end of the 2' supply hose to the elbow on the blender output and the other
end to the elbow on the IC-2A patient supply input.

5
6
UNPACKING
When received, the instrument should be immediately unpacked and checked to see
that all component parts have been received, and that there is no damage from transit.

If the IC-2A was shipped directly to you and damage due to shipment is found, notify the
carrier at once. Only you, the consignee, can make a claim against the carrier for
damage in shipment.

If you received the equipment from a BMD dealer, return it to the dealer for adjustment.

In addition to the ventilator, the following items are shipped standard as part of the IC-
2A equipment. Check to assure that all items have been received.

For IC-2A, Catalog #8001A or 8001AM

QTY CAT. # DESCRIPTION
1 CCAP005 CAP ON IC-2A PATIENT OUTLET
1 2013 MOUNTING BRACKET FOR 1" POLE
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 MR-CONDITIONAL VENTILATOR
1 CCAP005 CLEAR CAP ON IC-2A PATIENT OUTLET
1 2001M HIGH/LOW FLOW MR-CONDITIONAL BLENDER
1 1060-5HM 5-LEGGED HEAVY DUTY MR-CONDITIONAL STAND
1 PFIT143 SUPPLY ELBOW ADAPTERS
1 1020 ADULT TEST LUNG
2 8002A DISPOSABLE PATIENT CIRCUIT
1 8050A IC-2A INSTRUCTION MANUAL
1 2120 BLENDER INSTRUCTION MANUAL
1 1005M MR-CONDITIONAL DELUXE REGULATOR FOR O2 E-CYLINDER
1 1006M MR-CONDITIONAL DELUXE REGULATOR FOR AIR E-CYLINDER
1 1061M E-CYLINDER BRACKET SET FOR HEAVY DUTY STAND
2 MLAB024 WARRANTY CARD
7
QTY CAT. # DESCRIPTION
1 8001AM IC-2A MR-CONDITIONAL VENTILATOR
1 CCAP005 CLEAR CAP ON IC-2A PATIENT OUTLET
1 2001M HIGH/LOW FLOW MR-CONDITIONAL BLENDER
1 1060-5HM 5-LEGGED HEAVY DUTY MR-CONDITIONAL STAND
1 PFIT143 SUPPLY ELBOW ADAPTERS
1 1020 ADULT TEST LUNG
2 8002A DISPOSABLE PATIENT CIRCUIT
1 8050A IC-2A INSTRUCTION MANUAL
1 2120 BLENDER INSTRUCTION MANUAL
1 1005M MR-CONDITIONAL DELUXE REGULATOR FOR O2 E-CYLINDER
1 1006M MR-CONDITIONAL DELUXE REGULATOR FOR AIR E-CYLINDER
1 1061M E-CYLINDER BRACKET SET FOR HEAVY DUTY STAND
2 MLAB024 WARRANTY CARD
1 2005ICHC HOSE KIT FOR 8001AMBC (see below)

2005ICHC HOSE 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

8
WARRANTY
The IC-2A Ventilator is warranted to be free from defects in workmanship and material
for one (1) year from the date of purchase. To insure its performance is maintained, any
repair during this warranty period must be performed by BMD.

The warranty does not apply to the patient circuit and hoses supplied with the
instrument. 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 with the paperwork.

There is no oral or implied warranty of the instrument's fitness for a particular purpose
other than its intended use.

9
WARNINGS
If the IC-2A is used with a blender, a separate, calibrated oxygen analyzer (complying
with ISO 7767) should be used.

Clean, dry, regulated gas supplies at 50 ±5 PSI (345 ±34.5 kPa) must be used at all
times or malfunction may result. Note carefully that the logic gas supply should be
100% oxygen at all times to give the greatest accuracy of the control settings and to
assure the most trouble-free operation. The supply connected to the patient supply
connector may be either: 100% oxygen, air from a dry gas medical air compressor
system, or a blended mixture of air and oxygen.

A TWO-WAY SAFETY RELIEF VALVE is installed internally. This valve opens when
pressure in the hose delivering gas to the patient rises above 120 cmH 2O ±10 cmH2O or
falls below -4 cmH2O. Its purpose is to limit maximum circuit pressure and to allow
patient inspiration in the unlikely event of failure of the gas supply. Its screen must be
maintained clear and unobstructed. It is meant to allow spontaneous breathing for a
short time only until the operator can respond to the disconnect alarm and rectify the
supply malfunction. In such a situation, its use in a contaminated environment could be
hazardous.

Do not re-use disposable breathing circuits. Re-use of disposable (single-use) breathing

circuits can result in contamination (patient infection) or circuit degradation (circuit can
fall apart, develop holes, or exhibit polymer decay).

Do not use in an MRI room unless the IC-2A has been built by Bio-Med Devices for
such an environment. This will be indicated by an MR-conditional label on the unit and
an “M” at the end of the serial NUMBER.

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.

Do not continue to use a ventilator which has been impacted or abused.

Volume-limited ventilators should not be used on unattended patients.

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 pressure jet will render the
SAFETY RELIEF VALVE ineffective.

CAUTIONS
The IC-2A ventilator is intended for use by qualified clinical personnel only. This
instruction manual should be read in its entirety before using the equipment.

Always test the IC-2A each time before connecting to the patient.

As noted later in the text of this manual, the IC-2A time cycle settings are affected by
large changes in barometric pressure, flow rates, and gas composition. They are
repeatable, however, within 5% under constant conditions. As with any ventilator,
10
periodic blood gas studies should be made to ensure proper levels of ventilation.

A one-way valve is installed internally in the patient manifold. This valve opens when
pressure in the hose delivering gas to the patient falls below -4 cmH2O. Its purpose is
to allow patient inspiration in the event of gas supply failure. It is meant to allow
spontaneous breathing for a short time only until the operator can respond to the
disconnect alarm and rectify the supply malfunction.

A patient bacterial filter should always be used with the IC-2A to prevent cross
contamination and protect the patient.

Always turn on the IC-2A before attaching 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 with the IC-2A.

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 than 1:1.

WARNING: Do not use in an MR room unless the IC-2A has been built by Bio-
Med Devices for such an environment. This will be indicated by an MR-
conditional label on the unit and an “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: From 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.

12
 Oxygen concentration: variable, 21% to 100% with external blender.

Respiratory rate: variable, 1⅟₃ to 66 breaths/min.

Tidal volume: variable, 0 to over 3000 ml.

I/E ratio: variable.

Respiratory and I/E ratio are determined by INSP. TIME and EXP. TIME control
settings. These settings are repeatable within 5%.1 For greater accuracy of
settings an external monitoring device may be used.

Oxygen concentration is varied by the use of an external accessory blender or

premixed gas supply. Care should be taken to select a blender capable of
maintaining constant supply pressure over the full range of flow rates the IC-2A
provides. The O2 concentration should be monitored with a separate calibrated
oxygen monitor.

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 slightly by flow. When flow is increased, the pressure levels set by
these controls will increase somewhat. These changes may be noted on the
pressure gauge, and the settings readjusted.

1
At elevations above sea level, the intervals set by the INSP. TIME and EXP. TIME controls are
increased due to lower barometric pressure. The difference is about 2.5% per 1000' of elevation.
With an air supply connected to the POWER OXYGEN inlet fitting, the time intervals are about 10%
less than with pure oxygen connected.

13
II. DESCRIPTION

A. PRINCIPLES OF OPERATION
1. IPPV
With the CYCLE/CPAP-MANUAL selector set in cycle and
NORMAL/SIMV selector set in normal, the IC-2A acts as a controller or
assist/controller. A pilot valve operated by the timing signal from the fluid
logic opens for a preset length of time (Insp. Time) allowing gas to flow at
some rate established by the flow rate control. During this time the
exhalation valve is pressurized, closing the exhalation port and thus
insuring that all gas is directed to the patient. The gas supply is a high
pressure source and since the pressure reached in the patient is relatively
low, the flow rate remains constant, independent of changes in patient
pressure. The ventilator is a constant flow generator.

a. Volume Limited
The pressure developed in the system depends on the total
compliance and the volume of gas delivered. If the adjustable
pressure limit is set higher than the pressure that is reached, then
no gas is dumped to atmosphere and the ventilator is volume
limited. In this mode the tidal volume (Vt) is the product of
inspiratory time and flow rate.
Vt = T l x Vl

In this mode the pressure limit is normally set 5-10 cmH2O above
the pressure attained. It then acts as an upper level failsafe. If
patient resistance or compliance causes 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 pressure reached within the patient circuit is equal to
the maximum pressure limit established using the maximum
pressure control on the rear panel, the excess gas is dumped to
atmosphere and the unit is operating in a pressure-limited mode.
The ventilator may be used continuously in the pressure limited
mode by setting the maximum pressure and adjusting the
inspiratory time and flow rate to give a large enough volume of gas
per breath to insure that the preset pressure level is reached on
each cycle. When the pressure limit is reached, it is held until the
end of inspiration thus producing a "plateau" type pressure
waveform.

The lowest rate attainable in the IPPV mode is established by the

backup timer at 6 breaths per minute.

2. Synchronized Intermittent Mandatory Ventilation (SIMV)

The IC-2A provides a unique triggered demand-flow system for the
14
 addition of a constant flow source. It obviates the need of check valve,
flowmeter, bag, etc. The expiratory time is set in the IMV range allowing
the patient one or more spontaneous breaths between the machine
assisted breaths. It should be noted that in the SIMV mode it is essential
that the inspiratory effort control be set so that the patient can trigger the
machine at all times. When the NORMAL/SIMV selector is set in the
SIMV position it will be observed that while the ventilator cycles with each
inspiratory effort, the pressure builds up in the patient circuit only after the
end of the expiratory time. This is achieved by pressurizing the exhalation
valve only after the patient triggered breath at the end of the expiratory
time (assisted breath). At the end of the expiratory time the machine waits
for the next inspiratory effort and therefore when the assisted breath is
provided it is synchronized to the patient's breathing effort. In the SIMV
mode, in the event no patient inspiratory effort is sensed for a period of ten
seconds, a "backup timer" will provide a "backup breath." Every time an
inspiratory effort is sensed, whether for a spontaneous or an assisted
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.

Each time the machine is cycled it provides gas flow to the patient even
when the exhalation valve is not pressurized. If the inspiratory time and
flow rate are set in a way that provides more gas than needed by the
patient, the excess passed to the atmosphere. Should the patient require
more gas during a spontaneous breath than is provided, and if a negative
pressure is still 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
spontaneous tidal volume as possible. With this triggered demand-flow
system, it is only necessary to trigger the unit initially. The IC-2A then
provides a bolus of gas equal to the product of inspiratory time and flow
rate. Unlike other systems it is not necessary to maintain a constant
negative pressure of several cmH2O during each spontaneous breath.
This eliminates the oscillations observed in other systems at low flow rates
and makes possible the use of a normal bubble type humidifier with the
bubbler in place. Note that during the spontaneous breaths, even though
the exhalation valve is not pressurized, there may be a buildup of 3-5
cmH2O pressure depending on flow rate set. This is due to slight
resistance of the exhalation valve at high flow rates.

3. Positive End Expiratory Pressure (PEEP)

The PEEP/CPAP control applies a constant pressure to the exhalation
valve which may be adjusted to give a pressure in the patient circuit from
0 to 25 cmH2O. The PEEP/CPAP control is operative in all modes of
operation. The inspiratory effort control may be set to compensate for the
PEEP/CPAP pressure level in the patient circuit. Whenever the
PEEP/CPAP level is changed, the inspiratory effort control should be
readjusted.

15
 4. Continuous Positive Airway Pressure (CPAP)
When the CYCLE/CPAP selector switch is placed in the CPAP-MANUAL
position the function of the IC-2A is very similar to the SIMV mode. In the
CPAP mode, an inspiratory effort triggers the flow of a volume of gas
equal to the product of inspiratory time and flow rate. However, in this
mode the high pressure is not applied intermittently to the exhalation
valve. Only the PEEP/CPAP control is operative. The PEEP/CPAP
control may be turned fully clockwise, thus applying zero pressure to the
exhalation valve. In this way the ventilator may be used to administer, on
demand, gas of a preset oxygen concentration at ambient pressure. In
both the SIMV and CPAP modes there may be a momentary fluctuation of
a few cmH2O pressure depending on the flow rate, inspiratory time,
system compliance and gauge response.

Note that in this mode, the expiratory time should be turned to maximum
(fully clockwise) and the NORMAL/SIMV selector should be in the SIMV
position. This will prevent false cycling and help to reduce gas
consumption. It is also advisable, for added safety, the maximum
pressure control be turned off (fully clockwise) when using the CPAP
mode.

5. Manual Mode
The manual control can be used for hyperventilating before suctioning,
sighing the patient or synchronizing 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 time set with
the inspiratory time control. The tidal volume is then equal to the product
of inspiratory time and flow rate (volume limited).

If the manual button is held in for a time greater than the preset inspiratory
time, then inspiration will last during the entire time that the manual button
is depressed. In this case the volume delivered is unknown. The
pressure gauge may be observed as an indicator of degree or ventilation.
By using the PEEP/CPAP control it is possible to ventilate manually with
PEEP. The MAX. PRESSURE control may also be used in manual mode
to pressure limit each breath.

B. CONTROLS, INDICATORS AND CONNECTIONS

1. Controls
a. CYCLE/CPAP-MANUAL Switch
Selects non-cycling (CPAP) or time-cycled (cycle) modes or
operation.

b. Inspiratory Time
Sets inspiratory time in time cycled modes. Calibrated from 0.4 to
16
 2.0 seconds.

c. Expiratory Time
Sets expiratory time in time-cycle modes. Calibrated from 0.5 to
4.0 seconds (may be set to 45 seconds or more in IMV range).

d. Flow rate
Sets inspiratory flow rate. Calibrated from 0 to 75 LPM.

e. Inspiratory Effort
Adjusts the patient trigger sensitivity.

f. PEEP/CPAP
Sets PEEP level when cycle selector switch is in the CYCLE
position or CPAP level when switch is set to CPAP.

g. NORMAL/SIMV Switch
Selects between normal time cycled mode and SIMV mode.

h. On/Off Switch
Controls main power to the fluid logic.

i. Manual Button
Provides manually controlled inspirations.

j. Maximum Pressure (Rear Panel)

Sets the upper pressure limit of each cycle.
2. Indicators
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. Patient Gas Supply

DISS oxygen fitting for connection to source of clean, dry, 50 5
PSI (345 ±34.5 kPa ) supply of patient breathing gas mixture, e.g.,
from a blender.

c. Patient Hose Connection

22mm connector (inside 15mm) for attaching main patient hose.

17
 d. Exhalation Valve Connector
Powers the exhalation valve.

e. Pressure Gauge
Connects to pressure gauge line "T" adapter to give proximal
airway pressure.

C. SPECIFICATIONS
Gas Supply
Logic Oxygen: Clean, dry, medical grade 50 ±5 PSI (345
±34.5 kPa ) 100% oxygen.

Patient Supply: Clean, dry, oil free 50 ±5 PSI (345 ±34.5 kPa )
patient breathing gas mixture.

Inspiratory Time: Calibrated2 from 0.5 to 4.0 seconds (variable to

45 seconds or more, uncalibrated, in the IMV
range).

Flow rate: Calibrated from 0 to 75 LPM.

Maximum Pressure Setting: Variable from 0 to 120 ±20 cmH2O. This is

dependent upon the type of exhalation valve
used. The IC-2A is calibrated using the Bio-
Med Devices disposable patient circuit and
exhalation valve, Part #8002A.

Pressure Gauge: -10 to +120 cmH2O; ±3% full-scale accuracy.

(at ATPD- ambient temperature & pressure dry)

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.

Insp Breathing Circuit Resistance: 0.01 cm H2O / lpm, at 60 lpm flow (model 8002A)
Exp Breathing Circuit Resistance: 0.05 cm H2O / lpm, at 60 lpm flow (model 8002A)

Weight: 4.1 kg (9 lbs.)

Physical Dimensions: 8.57 X 15.56 X 26.04 cm (3-1/8 x 6-1/8 x 10-
1/4 in.)

2
INSP. TIME and EXP. TIME control settings are calibrated at sea level and 20 degrees Celsius,
ATPD, using USP oxygen. Large changes of barometric pressure or altitude changes, or use of
diluted oxygen will affect time calibration. Time settings are repeatable within 5%.

18
Storage Temperature: 32° to 122°F (0° to 50°C)

Operating Temperature: 14° to 122°F (-10° to 50°C)

19
III. INSTALLATION CONSIDERATIONS

A. EQUIPMENT REQUIRED
All equipment required for use of the IC-2A has been supplied with the
instrument, except for the gas supply, possibly the blender, and any patient
appliances. No special tools are needed.

It will be convenient to have available a test lung, BMD Part #1020, when setting
the ventilator parameters, before connecting to a patient.

B. SUPPLY GAS
The supply gas is normally a pressurized tank(s) or wall source of medical or
therapy grade oxygen and/or air. The pressurized tanks should be fitted with
regulators adjusted to 50 5 PSI (345 ±34.5 kPa).

NO FLOW-RESTRICTING DEVICE (e.g. FLOWMETER, THROTTLING VALVE)

SHOULD BE PLACED IN THE SUPPLY LINE. A flow-restricting device
interferes with the operation of the pneumatic logic and may render the time-
cycling inoperative.

The IC-2A will operate with a supply pressure outside of the 50 ±5 PSI (345
±34.5 kPa ) range, but accuracy of settings may be impaired. IN NO 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 that provides sufficient flow rates at the
specified constant pressure may be used. BMD recommends use of the BIO-
MED High Flow Blender, catalog #2001 or #2002, with supply disconnect alarms.
It should be connected to the "patient gas" connection.

Humidifier- any adult intensive care humidifier intended for use with a ventilator
(such as the Fisher & Paykel model available from Bio-Med Devices) may be
used. It should be connected in line in the main patient hose. Due to the unique
triggered demand-flow system of the IC-2A, a bubble tower, if present in the
humidifier used, may be left in place without adversely affecting the operation of
the IC-2A.

20
Pressure Alarms- a high/low pressure alarm (such as the Bio-Med Devices’ M-10
or M-1) may be connected to the pressure gauge line or main patient hose. IT
MUST ALWAYS BE USED WHENEVER THE IC-2A IS USED UNATTENDED.

Rate-I/E Ratio Monitor- (such as the Bio-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.

21
IV. SET UP
CAUTION: Antistatic or electrically conductive hoses or tubing should not be used.

A. CONNECTION OF GAS SUPPLY

1. Connect a 50 PSI (345 kPa) oxygen source to the logic power gas supply
connector. Only 100% oxygen should be used for proper operation.

2. Connect the patient gas supply to the DISS fitting labeled "patient gas
supply." This may be from the output of a blender or any pre-blended gas
mixture of the desired oxygen concentration. The oxygen concentration
delivered to the patient is the same as the oxygen concentration supplied
to the ventilator in the patient gas fitting.

It is essential that:

THE SUPPLIES ARE REGULATED 50 PSI (345 kPa) SOURCES

WITHOUT FLOW RESTRICTING DEVICES (E.G., FLOWMETER,
NEEDLE VALVE, ETC.);

HOSE FITTINGS SHOULD BE HAND TIGHTENED TO AVOID

DAMAGE TO FITTINGS;

THE GAS SUPPLY SHOULD BE CLEAN AND DRY.

B. CONNECTION OF PATIENT CIRCUIT

1. Connect the corrugated humidifier hose 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.
After selecting desired operating parameters observe proper functioning
before attaching to the patient.
CAUTION: Do not re-use disposable breathing circuits.
Note:
The IC-2A is supplied with the Bio-Med Devices patient circuit, catalog #8002A.
It is recommended using this circuit only, as the maximum pressure limit and
maximum PEEP pressure are calibrated using this exhalation valve. If another
exhalation valve is used in an emergency situation, there may be a difference in
the maximum pressure limit and maximum PEEP pressure attainable, depending
on the area ratios of the particular exhalation valve used.

22
 Exhalation Valve
w/ Collection Head

Airway Pressure
Tee

To the Patient

Airway Pressure Patient Connection

Exhalation Valve

23
V. SELECTION OF VENTILATION PARAMETERS AND
ADJUSTMENT OF CONTROLS

A. INTERMITTENT POSITIVE PRESSURE VENTILATION (IPPV) WITH

OR WITHOUT PEEP
Determine and note patient requirements for respiratory rate, I/E ratio and tidal volume.
Refer to Table I to find inspiratory time (TI) and expiratory time (TE). Obtain the correct
flow rate setting for the desired title volume at the set inspiratory time, from Table II.

Step 1- set ON/OFF selector to ON.

Step 2- set CYCLE/CPAP-MANUAL switch to cycle position.

Step 3- set NORMAL/SIMV switch to normal position.

Step 4- set maximum pressure control fully counterclockwise (maximum),

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 = 2.0 sec.
From Table II:
Flow rate = 30 LPM (0.5 L/sec.)
[Tidal volume (liters) = flow rate (L/sec) x Insp. Time (sec.)]

Step 8- ATTACH TEST LUNG TO PATIENT PORT AND OBSERVE PROPER

CYCLING.

Step 9- connect to patient.

Step 10- set inspiratory effort control for proper patient triggering.

Step 11- volume-limited or pressure limited operation is established as follows:

a) For volume limited operation - set the MAX. PRESSURE control fully
counterclockwise.
24
 With patient airway connected to patient port observe and note maximum
pressure during cycle.

Detach patient airway from WYE and block patient port.

Adjust MAX. PRESSURE control to a level 5 to 10 cmH2O above that

reached with patient connected.

Re-connect the patient airway to the WYE.

The IC-2A will now be limited to the tidal volume set, but maximum
pressure will be limited in the event of changes in resistance or
compliance.

b) For pressure-limited operation:

Adjust MAX. PRESSURE control until the desired pressure limit is attained
during inspiration. Note that the MAX. PRESSURE level is somewhat
affected by the flow rate. It should be set with the particular flow rate
used.

The IC-2A will now be limited to the pressure set. When operating in this
mode, the exact Tidal Volume is unknown, since gas is vented to the
atmosphere through the exhalation valve as soon as the present pressure
limit is reached during each inspiration.

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.

Note:
During IPPV an assist control breath will cause response of both the cycle and
demand indicators. A control cycle will activate only the cycle indicator.

B. SYNCHRONIZED INTERMITTENT MANDATORY VENTILATION

(SIMV)
Step 1- set NORMAL/SIMV selector to SIMV position.

Step 2- set inspiratory effort control for proper patient triggering.

The volume of gas delivered during spontaneous breaths, equal to the product of
insp. time and flow rate, should be as close as possible to the patient's tidal
volume. However, if it is set too high the excess gas not breathed by the patient
is vented to atmosphere through the exhalation valve. If it is too low and the

25
 patient requires more gas, another bolus of gas will automatically be delivered to
the patient as long as the inspiratory effort sensor detects a negative pressure.

Step 3- set PEEP level, making certain to readjust the inspiratory effort control
to compensate for PEEP.

Note:
In the SIMV mode it is unnecessary to add an external constant flow source due
to the triggered demand flow system. It is necessary, however, that the
inspiratory effort control be properly adjusted at all times to assure proper
operation.

Step 4- observe assisted breath following termination of expiratory time.

Adjust tidal volume, equal to the product of inspiratory time and flow
rate, to its proper level.

Note:
In the SIMV mode, in the event no patient inspiratory effort is sensed for a period
of ten seconds, a "backup timer" will provide a "backup breath." Every time an
inspiratory effort is sensed, whether for a spontaneous or an assisted 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 the SIMV mode, 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 THE PATIENT
BEFORE TURNING THE VENTILATOR BACK ON, IN ORDER TO AVOID
ERRONEOUS BREATHS.

THE MAXIMUM PRESSURE CONTROL MUST BE TURNED OFF (FULLY

CLOCKWISE) IN THE CPAP MODE.

Step 1- set PEEP/CPAP control fully clockwise (zero).

Step 2- set CYCLE/CPAP-MANUAL switch to CPAP-MANUAL position.

Step 3- turn expiratory time control fully clockwise to maximum.

Step 4- set NORMAL/SIMV switch to SIMV.

Step 5- adjust inspiratory time and flow rate to give administered gas volume
sufficient to meet patient demand.

Step 6- connect to test lung.

26
 Step 7- set desired CPAP level using the PEEP/CPAP control.

Step 8- adjust inspiratory effort for pre-set CPAP level, for proper patient
triggering.

NOTE THAT IT IS ESSENTIAL WITH THE TRIGGERED DEMAND FLOW OF

THE IC-2A, THAT THE INSPIRATORY EFFORT BE PROPERLY ADJUSTED
TO ASSURE THAT THE PATIENT CAN OBTAIN GAS.

As in the SIMV mode, no external constant flow source is necessary.

Step 9- connect to patient and observe pressure gauge. Adjust inspiratory

time and/or flow rate to assure that sufficient gas is provided and that
the CPAP level is maintained.

In CPAP, only the demand indicator will be activated.

D. MANUAL CYCLING
Step 1- set CYCLE/CPAP-MANUAL selector to CPAP-MANUAL position.

Step 2- 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 lung by depressing manual button and observing

pressure gauge for proper operation.

Step 7- connect to patient and ventilate by depressing manual button long

enough on each cycle to set the inspiratory timer. If the manual button
is held in longer than the preset inspiratory time, then inspiration will
continue during the entire time that the manual button is depressed.
Observe chest excursion and pressure gauge for proper operation.

27
VI. PRECAUTIONS
 To assure that operation will be trouble-free, attention should be given to the
following points:

 ALWAYS TEST THE IC-2A EACH TIME BEFORE ATTACHING TO A PATIENT.

 All hoses should be securely fastened to fittings. Hand-tighten to avoid damage

to fittings.

 Gas supplies must be maintained at 50 ±5 PSI (345 ±34.5 kPa).

 Flow restrictions (e.g., flowmeter, check valves, etc.) must not be placed in
supply lines.

 Gas going to patient should not be super-saturated, as evidenced by excessive

rain-out in the tubing. Condensation droplets on the inner walls of the tubing is
normal.

 Humidifier, when used, must be placed between PATIENT connection on IC-2A

and hose in patient circuit. DO NOT PLACE IN SUPPLY LINE.

 When setting INSP. TIME and EXP. TIME controls, for optimum repeatability,
always approach setting by turning knob in a counterclockwise direction.

 Humidifier should have low compliance, and water maintained at a high level to
minimize compliance changes.

 Expiration Valve must be positioned with diaphragm cap (white section with pilot
hose connection) up. Exhaust port, on bottom, should be unimpeded. (Clear
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 USED UNATTENDED, ALWAYS USE

WITH AN ALARM SYSTEM, SUCH AS THE BIO-MED DEVICES M-10 OR M-1.
PRESSURE ALARMS SHOULD BE T-CONNECTED TO PRESSURE TUBING
ATTACHED TO GAUGE FITTING OF IC-2A.

 When setting controls, always start with PEEP/CPAP control fully clockwise, and
MAX PRESSURE control fully counterclockwise to avoid setting PEEP/CPAP
above the maximum pressure limit.

 Never force the needle valve controls. (INSP. TIME, EXP. TIME, PEEP/CPAP,
and MAX. PRESSURE). When they are seated (fully clockwise) they must be
firm, but not over-tightened.

 Should the INSP. TIME, EXP. TIME, or FLOW RATE control knobs come loose
for any reason, do not attempt to re-fasten them. The calibration of these

28
 controls depends on the position of the knob on the shaft. If the control knobs
come loose, the ventilator must be returned to BMD for recalibration.

 When the Ventilator is used at altitudes significantly above sea level, or in non-
pressurized aircraft, the calibration of INSP. TIME and EXP. TIME must be
corrected. The actual times will be greater than the panel marking by
approximately 2 ½% for every 1000' of altitude.

 The pressure levels set by the MAX. PRESSURE and PEEP/CPAP controls are
somewhat affected by the flow rate. These controls should be set with the flow
rate used. If flow rate is changed, the MAX. PRESSURE and PEEP/CPAP levels
should be checked.

 When a compressor is used as the power 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 model # 8002A be used with the
IC-2A. The use of other valves may cause the attainable upper level of PEEP
and maximum pressure to change. If necessary, the unit may be recalibrated for
available exhalation valves.

 Always turn on the IC-2A before attaching to the patient, to avoid erroneous
breaths.

 If ventilator internal contamination results from not using a patient filter, do not try
to clean the ventilator internally; instead return it to the factory for evaluation.

 Negative pressure (subatmospheric) is not available with this ventilator during the
expiratory phase.

 Whenever the IC-2A is turned off, disconnect the patient before turning the
ventilator back on, in order to avoid erroneous breaths.

29
VII. MAINTENANCE

A. NORMAL CARE
The IC-2A Ventilator requires very little maintenance. It should be protected from
abusive mechanical shock and kept in a clean condition.

The IC-2A should only be cleaned by wiping the outside surfaces with alcohol
applied to a tissue or cloth. It should never be sprayed with or immersed in any
other liquid.

The instrument should be returned to BMD for repair.

The patient circuit supplied, BMD part #8002A, is disposable and should be
replaced for every patient, or during extended periods for a single patient. It is
recommended that the patient circuit be changed at least every 24 hours.

Care should be taken in connecting supply hoses to the POWER OXYGEN and
AIR fittings. Hand tightening of these fittings is sufficient. Do not over-tighten
with a wrench, as the fittings could be damaged. Never connect 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 kPa) to LOGIC GAS SUPPLY

Connect 100% 02 supply at 50 PSI (345 kPa) to PATIENT GAS SUPPLY
CYCLE/MANUAL CPAP to CYCLE
INSPIRATORY TIME to 1 sec
EXPIRATORY TIME to 2 sec
FLOW RATE to 30 LPM
MAXIMUM PRESSURE fully CCW
PEEP PRESSURE fully CW
NORMAL/SIMV to NORMAL
INSPIRATORY EFFORT fully CW
ON/OFF valve to OFF
Attach patient circuit - patient end occluded

NOTE: Read through each numbered procedure thoroughly before proceeding

with that check. Before starting each check, return unit to above settings.

1. LOGIC SUPPLY INTEGRITY

Turn patient gas supply off. Place your ear near the back of case. There should
be no indication of internal leak.

30
2. PILOT VALVE BLEED
With both supplies on, place your ear near back of case. An audible internal leak
is normal.

3. PILOT VALVE SEAL

With both supplies pressurized and ON/OFF valve set to OFF, occlude the circuit
exhalation valve exhaust port and observe the manometer on the unit. There
should be no continuous rise in pressure indicated by manometer.

4. MANOMETER
Using a variable low-pressure source and known standard, verify 3% full-scale
accuracy and a zero of ±1 cm.

5. RELIEF VALVE
CAUTION: Proceed with care. If the relief valve is malfunctioning, damage to the
manometer may occur during this check.

NOTE: The point at which the relief valve begins to fully open may cause
oscillation in the manometer. This is normal.

Set Flow Rate to minimum flow. Set ON/OFF switch to ON. Occlude circuit
exhalation valve exhaust port and observe manometer. Slowly increase the flow
rate to 20 LPM. A minimum of 100 cm of pressure should be indicated during
inspiratory. Continue to slowly increase flow to 75 LPM. The pressure during
inspiratory should not be less than 100 cm or greater than 130 cm.

6. MAXIMUM PRESSURE
Set INSPIRATORY TIME to 2 seconds. 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. Except at start of inspiratory, no more than 1 cm rise in pressure
should be observed.

8. FAILSAFE
Set ON/OFF switch to ON. Manometer should indicate Maximum Pressure
during Inspiratory. Slowly decrease the logic supply pressure. At a supply
pressure of 30 PSI or less, the patient circuit should stop pressurizing while the
unit continues to cycle.

9. PEEP PRESSURE
Turn PEEP knob fully CCW and install test lung at patient end of circuit. Set
ON/OFF switch to ON. The test lung should fill by the second breath and the
manometer should indicate a PEEP pressure of 25 cm ±3. Switch
CYCLE/MANUAL CPAP switch to MANUAL CPAP. Unit will continue cycling
without inspiratory pressurization and with no CYCLE INDICATOR action. PEEP
pressure should be 25 cm ±3. Press and release the Manual Button. A
pressurized bolus of gas will be delivered.
31
10. PEEP ZERO
Set ON/OFF switch to ON. Observe manometer. No pressure should be
indicated during the expiratory phase.

11. INSPIRATORY EFFORT

Remove occlusion from patient end of circuit. Set ON/OFF switch to ON. With 15
±5 cm of negative pressure applied to the patient circuit, the DEMAND
INDICATOR should activate and the unit should trigger (initiate a breath). Turn
the INSPIRATORY EFFORT knob CCW until the unit auto-cycles (demand
triggers at the end of every inspiratory phase). Slowly turn the knob back CW
until the unit stops auto-cycling. A demand of 0.5 cm of negative pressure
applied to the patient circuit should trigger a pressurized breath.

Install the test lung on patient circuit. Turn the PEEP knob fully CCW. Turn the
INSPIRATORY EFFORT fully CCW. If the unit does not auto-cycle at this point,
slowly decrease the PEEP pressure until the unit does auto-cycle. This must
occur before the PEEP pressure has been reduced to less than 20 cm.

12. INSPIRATORY TIMES

Attach the patient end of the patient circuit to a test instrument used for
measuring inspiratory time. Set ON/OFF valve to ON. While turning the
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 back-up timer it is
important that the expiratory knob be positioned against the stop before the end
of the inspiratory phase. The back-up timer should trigger the unit into
inspiratory, indicating an expiratory time between 9.0 and 12.0 sec. As the unit
continues to be cycled by the back-up timer, the expiratory times should not
decrease to less than 9.0 seconds.

14. MAXIMUM IMV TIME

Set up as in #12. Set EXPIRATORY TIME knob against the stop in the IMV
range. Set NORMAL/SIMV to SIMV. Set ON/OFF switch to ON. Turn the
INSPIRATORY EFFORT knob CCW until the unit auto-cycles. Using a
stopwatch, measure the time between observed pressurized breaths. This time
should be between 45-150 sec.

15. FLOW RATES

Attach the patient end of the patient circuit to a test instrument used for
measuring flow. Set ON/OFF valve to ON. Verify that indicated flow rates are
within ±10% of panel values. Turn FLOW RATE knob in a CCW direction.

32
C. CALIBRATION
The accuracy of the instrument's indicators and controls should be retained over
its life as long as it has not been subject to abuse. The calibration of the
pressure gauge, flow control, and timing controls may be checked with relative
ease.

Note:
The calibration of the two timing controls (INSP. TIME and EXP. TIME) and the
flow rate control depends on the fixed position of the knobs on their shafts.
Should these knobs come loose, do not attempt to refasten. Return the
instrument to Bio-Med Devices for repair.

The pressure gauge readings can be compared to a standard by teeing into the
hose connected to the GAUGE fitting of the IC-2A, and connecting it to the
standard gauge.

Should the gauge need zeroing, this may be accomplished while the instrument
is inoperative by removing the gauge’s lens and setting the zero screw adjust on
the front 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 gases, and handling. It is
recommended that units operated on a regular basis be factory serviced
annually. For units used infrequently, a maximum of 3 years between factory
service is recommended. Qualified personnel following prescribed checkout
procedures may periodically verify calibration. The annual service procedure
should be performed by experienced personnel at the factory. Field service
beyond minor adjustment is not recommended due to the IC-2A's unique
pneumatic logic circuit.

PACK THE INSTRUMENT SO THAT ITS METERS, CONTROL KNOBS, AND

CONNECTIONS ARE ADEQUATELY PROTECTED. SHIP PRE-PAID TO:

BIO-MED DEVICES INC.

61 SOUNDVIEW ROAD
GUILFORD, CT 06437 USA

33
TABLE I

RATE & I/E RATIO

INSPIRATORY TIME (SEC.)

.40 .50 .75 1.00 1.50 2.00

67 60 48 40 30 24
.50
1:1.3 1:1 1.5:1 2:1 3:1 4:1
60 55 44 38 29 23
.60
EXPIRATORY TIME (SEC.)

1:1.5 1:1.2 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
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)

34
TABLE II

TIDAL VOLUME

INSPIRATORY TIME (SEC.)

.40 .50 .75 1.00 1.50 2.00

20 130 170 250 330 500 670

30 200 250 375 500 750 1000

FLOW RATE (LPM)

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

75 500 630 940 1250 1880 2500

TIDAL VOLUME (ml.) = INSP. TIME X FLOW RATE (ml/sec.)

VT = T I X V I

35
APPENDIX A

AUTHORIZED REPRESENTATIVE IN THE EUROPEAN COMMUNITY

Bio-Med Devices’ Official Agent in Europe is:

Medical Market I.N.T. AB

Sehlstedtsgatan 6
115 28 Stockholm
Sweden

Telephone: +46-08-767 70 00
Fax: +46-08-731 90 09

36
APPENDIX B

IC-2A Ventilator MR Information

Non-clinical testing has demonstrated that the IC-2A adult/pediatric MRI ventilator is MR
Conditional. It can be scanned safely under the following conditions:

 Static magnetic field of 3-Tesla

 Spatial gradient field of 262-Gauss/cm or less

 Maximum MR system reported, whole body averaged specific absorption rate

(SAR) of 2-W/kg for 15 minutes of scanning

 MR image quality may be compromised if the area of interest is in the same area
or relatively close to the position of the device. Therefore, it may be necessary to
optimize MR imaging parameters for the presence of this device.

 Additional requirements:

The IC-2A must be used with the BMD MR-conditional stand, and the stand’s wheels
that have integral wheel locks must be locked.

Do not place the IC-2A & stand closer than one foot away from the MR bore (do not
place the IC-2A inside the MR bore).

If using supply gas cylinders and regulators, use only MR-conditional aluminum gas
cylinders and regulators (observe manufacturer’s published MR-conditional
requirements).

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