Impact DMR-0754 User manual

IMPACT Instrumentation, Inc.

Quality Procedure Manual

Proprietary

Section
DMR/0754
(M)/Test

Prepared By:

Approved By:

ISSUE _______

Date:

Date:

Rev.

G

754(M) PORTABLE VENTILATOR

TEST

PROCEDURES

Page

1 of 29

Revision Record

Date: CRO #: Revision:

6/26/98 98006 O to A
8/31/98 98027 A to B
4/22/99 99041 B to C

6/2/99 99056 Page 3 C to D
8/3/99 99080 Pages 28,29 C to D

8-20-01 01092 Pg 28 D to E

02-26-03 03018 F to G

IMPACT Instrumentation, Inc.

Quality Procedures Manual

Ref.DMR/0754(M)/Test
Page 2 of 29
Rev. G

ISSUE: ____

754(M) TEST PROCEDURE

1 GENERAL:

A. All tests performed with calibrated in house test equipment.
B. Burn In unit per DHR Operational Settings.

1.1 CONNECTIONS

1.1.1 Connect oxygen and external air to 754, pressurize to 50 PSI.

1.1.2 Connect disposable ventilator circuit to its respective gas outlet, transducer,
and exhalation valve connectors.

1.1.3 Connect AC Power Supply between External Power Jack and external power
source.

1.1.4 Connect battery pack.

1.2 SETTINGS

1.2.1 Unless otherwise stated, use the following settings

1.2.1.1 Mode = A/C

1.2.1.2 Rate = 15 BPM

1.2.1.3 I time = 1.0 second

1.2.1.1 Vt = 500 ml

1.2.1.2 FIO2 = 21%

1.2.1.3 External Air = ON

1.2.1.4 Sigh = OFF

1.2.1.5 Peep = 0 cmH2O

1.2.1.6 Pressure Plateau = OFF

1.2.1.7 High Pressure Alarm = 100 cmH2O

1.2.1.8 Low Pressure Alarm = 0 cmH2O.

Note: When going from one setting to another, a learning breath occurs as the unit’s

internal controls adjust. A Vt Alarm may occur during the learning breath, it
deactivates on the next breath. This is acceptable.

1.3 RT-200

1.3.1 When referring to the RT-200, the number in parenthesis given after the
reference is the operating mode the RT-200 should be in for that test
(Example: RT-200 (41) is the volume reading for oxygen).

1.3.2 A Disconnect Alarm may occur while using the RT-200 (especially during
low gas flows). This happens because the RT-200 flow sensor’s negligible
backpressure produces no pressure rise sensed by the ventilator’s airway
transducer. This is acceptable.

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Quality Procedures Manual

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1.4 TEST LUNG

1.4.1 When using test lung, unless otherwise stated, use settings:

1.4.1.1 R = 5

1.4.1.2 Compliance = .050 L/cmH2O.

2 TIDAL VOLUME

2.1 OXYGEN

2.1.1 Set Air/Oxygen mixer control to 100%.

2.1.2 Connect disposable ventilator circuit to RT-200 (41).

2.1.3 Test the tidal volumes from 200 - 3000 ml using the settings given in Table 1.
Work from smallest to highest values:

TABLE 1

Vt Set I Time Rate

200 ml 0.4 Sec 50bpm
300 ml 1.2 Sec 17bpm
500 ml 0.5 Sec 40bpm
500 ml 0.6 Sec 33bpm
500 ml 1.0 Sec 20bpm
500 ml 1.5 Sec 13bpm
500 ml 2.0 Sec 10bpm

750 ml 1.0 Sec 20bpm
1600 ml 2.4 Sec 12bpm
3000 ml 3.0 Sec 6bpm

2.1.4 When going from one setting to another, allow a learning breath to occur
before taking measurements.

2.1.5 Tidal volume readings from RT-200 must be within +/- 10% of Vt setting.

2.2 EXTERNAL AIR

2.2.1 Set Air/Oxygen Mixer to 21%. Set external air to “ON”.

2.2.2 Connect disposable ventilator circuit to RT-200 (42).

2.2.3 Test the tidal volumes from 200 - 3000 ml using the settings given in 2.1.3.
Work from smallest to highest values.

2.2.4 When going from one setting to another, allow a learning breath to occur
before taking measurements.

2.2.5 Tidal volume readings from RT-200 must be within +/- 10% of Vt setting.

2.3 COMPRESSOR

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2.3.1 Set Air/Oxygen Mixer to 21%. Set external air to “OFF”.

2.3.2 Connect disposable ventilator circuit to adult test lung.

2.3.3 Use a resistance of 5 and a compliance of .050 L/cmH2O.

2.3.4 Use one lung for tidal volumes from 200 - 2000 ml. Use dual lungs for 3000
ml setting.

2.3.5 Test the tidal volumes from 200 - 3000 ml using the settings given in Table
One. Work from smallest to highest values.

2.3.6 When going from one setting to another, allow a learning breath to occur
before taking measurements.

2.3.7 Tidal volume readings from test lung must be within +/- 10% of Vt setting.

3 FIO2

Note: The Oxygen Analyzer must be calibrated on a daily basis before initial use.

3.1 EXTERNAL AIR & O2

3.1.1 Setup

3.1.1.1 Set Air/Oxygen mixer control to 21%.

3.1.1.2 Set External Air to "On".

3.1.1.3 Connect disposable ventilator circuit to adult test lung.

3.1.1.3.1 Use a resistance of 5 and a compliance of .050 L/cmH2O.

3.1.1.4 Set I time to 1.0 sec and Vt to 500 ml.

3.1.1.5 Connect oxygen sensor to 22 mm gas outlet. Connect 22 mm disposable

hose to oxygen sensor.

3.1.2 Measure oxygen concentrations

3.1.2.1 Take oxygen concentration measurements at 21%, 40%, 60%, and 100%.

3.1.2.2 When making setting adjustments, allow a few breaths for the readings to

settle.

3.1.2.3 Readings must be within +/- 10% of FIO2 settings.

3.2 COMPRESSOR & O2

3.2.1 Setup

3.2.1.1 Set Air/Oxygen mixer control to 21%.

3.2.1.2 Set External Air to "Off".

3.2.1.3 Connect disposable ventilator circuit to adult test lung.

3.2.1.3.1 Use a resistance of 5 and a compliance of .050 L/cmH2O.

3.2.1.4 Set I time to 1.0 sec and Vt to 500 ml.

3.2.1.5 Connect oxygen sensor to 22 mm gas outlet. Connect 22 mm disposable

hose to oxygen sensor.

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3.2.2 Measure oxygen concentrations

3.2.2.1 Take oxygen concentration measurements at 21%, 40%, 60%, and 100%.

3.2.2.2 When making setting adjustments, allow a few breaths for the readings to

settle.

3.2.2.3 Readings must be within +/- 10% of FIO2 settings.

3.2.2.4 Readings may fluctuate more with compressor than with external air.

4 PEEP

4.1 SETUP

4.1.1 The default value for peep is 0 cmH2O.

4.1.2 Connect disposable ventilator circuit to test lung.

4.1.3 Use a resistance of 5 and a compliance of .050 L/cmH2O.

4.1.4 Use following unit settings

4.1.4.1 Mode = A/C

4.1.4.2 Rate = 15 BPM;

4.1.4.3 I = 1.0 SEC;

4.1.4.4 Vt = 500 ml.

4.1.4.5 FI02 = 21%; External Air = “OFF”.

4.2 CONTROL

4.2.1 Press the peep push-button once.

4.2.2 An audible beep should occur.

4.2.3 The peep LCD indicator should increase by 1 cmH2O.

4.2.4 Repeatedly press Peep push-button. Each time the push-button is pressed:

4.2.4.1 An audible beep should be heard.

4.2.4.2 The peep LCD indicator should increase by 1 cmH2O.

4.2.5 After reaching a value of 20 cmH2O, press the button once.

4.2.5.1 An audible beep should be heard.

4.2.5.2 The LCD indicator should read 0 cmH2O.

4.2.6 Press and hold the peep button.

4.2.6.1 One audible beep is heard.

4.2.6.2 The LCD indicator should begin to scroll up in value as long as the peep

button is held.

4.2.6.3 After reaching 20 cmH2O, the peep value should scroll back to 0 cmH2O.

4.3 PEEP LEAK

4.3.1 Using 1/8 hosebarb tee, 1/8 ID tubing, and a 3/16 hosebarb x 1/8 hosebarb
adapter, connect transducer line to RT-200 (12).

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4.3.2 Set peep value to 4 cmH2O.

4.3.2.1 Unit will "learn" the peep value. Allow a minute or so for the unit to

learn peep. You may need to lower the rate to 10 BPM to decrease
learning time. During the learning phase, there may be some
autotriggering. This is acceptable.

4.3.2.2 When the unit has reached 4.0 cmH2O (+/- 1.5 cmH2O), record the value.

4.3.2.3 Turn rate to 1 BPM.

4.3.2.3.1 In 18 seconds after the last breath (19 sec - I time), an Apnea alarm

should occur.

4.3.2.3.2 If an Assisted breath occurs before the Apnea alarm, the unit fails

Peep Leak test.

4.3.2.3.3 Peep should cancel during Apnea alarm.

4.3.2.4 Cancel Apnea alarm. Peep should reset itself to pre-apnea setting.

4.3.3 Set Peep value to 20 cmH2O and Rate to 15 BPM.

4.3.3.1 Unit will “learn” the peep value. Allow a minute or so for the unit to

learn peep. You may need to lower the rate to 10 BPM to decrease
learning time. During the learning phase, there may be some
autotriggering. This is acceptable.

4.3.3.2 When the unit has reached 20.0 cmH2O (+/- 1.5 cmH2O), record the

value.

4.3.3.3 Turn rate to 1 BPM.

4.3.3.3.1 In 18 seconds after the last breath (19 sec - I time), an Apnea alarm

should occur.

4.3.3.3.2 If an Assisted breath occurs before the Apnea alarm, the unit fails

Peep Leak test.

4.3.3.3.3 Peep should cancel during Apnea alarm.

4.3.3.4 Cancel Apnea alarm. Peep should reset itself to pre-apnea setting.

4.4 COUGH PROTECTION

4.4.1 Allow a minute or so for the unit to learn peep of 20 cmH2O.

4.4.2 Once peep is learned, during expiratory pause, push down on lung. This is
simulating a patient cough.

4.4.2.1 The exhalation valve should open up.

4.4.2.2 Airway pressure should start to go down to 0 cmH2O.

4.4.2.3 An Assisted breath will be triggered when the airway pressure drops

below baseline.

4.5 HIGH PEEP ALARM

4.5.1 Setup

4.5.1.1 Set Rate = 100 BPM.

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4.5.1.2

4.5.1.3 Vt = 180 ml.

4.5.1.4 FIO2 = 21%.

4.5.1.5 Peep = 4 cmH2O.

4.5.1.6 External Air = “OFF.

I time = .2 Sec.

4.5.2 Slowly increase rate until unit begins to autopeep. When the autopeep value
goes higher than 4 cmH2O, the High Peep alarm will activate.

5 APNEA:

5.1 SETUP

5.1.1 Set External Air = “ON”.

5.1.2 Connect disposable ventilator circuit to test lung.

5.1.2.1 Use a resistance of 5 and a compliance of .015 L/cmH2O.

5.2 APNEA IN A/C & SIMV

5.2.1 Use settings

5.2.1.1 Mode = A/C.

5.2.1.2 Rate = 15 BPM.

5.2.1.3 I time = 1.0 Sec.

5.2.1.4 Vt = 500 ml.

5.2.1.5 FIO2 = 21%.

5.2.1.6 Peep = 0 cmH2O.

5.2.2 Reduce rate to 1 BPM.

5.2.2.1 Apnea alarm should trigger in 18 Sec (19 Sec - I time) after last breath.

5.2.2.2 Put hose circuit on RT-200 (45) and measure the rate. It should be 12

BPM (+/- 10%).

5.2.2.3 Using RT-200, measure I time (46) and Vt (42). They should both be at

the current unit settings (+/- 10%).

5.2.3 Press the Mute/Cancel button and cancel Apnea. Settings should go back to
pre-apnea conditions.

5.3 APNEA IN CPAP

5.3.1 Connect disposable ventilator circuit to test lung.

5.3.2 Use a resistance of 5 and a compliance of .015 L/cmH2O

5.3.3 Use Settings

5.3.3.1 Mode = CPAP.

5.3.3.2 FIO2 = 21%.

5.3.3.3 Peep = 0 cmH2O.

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5.3.4 Generate an assisted breath by pulling up on test lung.

5.3.4.1 The Apnea-CPAP alarm should occur 10 seconds after the assisted breath.

5.3.4.2 The unit should have a PIP relief of 40 cmH2O (+/- 10%). Use the gauge

on the test lung to measure this value.

5.3.4.3 Using RT-200 (#45), measure the Rate. It should be 12 BPM (+/- 10%).

5.3.4.4 Using RT-200 (#46), measure the I time. It should be 1.667 Sec (+/-

10%).

5.3.4.5 Using RT-200 (#36), measure the flow. It should be 30 LPM (+/-10%).

5.3.5 Press the Mute/Cancel button and cancel Apnea. Settings should go back to
pre-apnea conditions.

6 OPERATIONAL

6.1 EXTERNAL POWER

6.1.1 Connect AC Power Supply between External Power Jack and external power
source.

6.1.2 Disconnect battery.

6.1.3 Verify unit operates while using external power.

6.2 BATTERY

6.2.1 Connect battery.

6.2.2 Disconnect external power.

6.2.2.1 An External Power Fail alarm should occur. Check off this alarm in the

Alarms section.

6.2.2.2 Cancel alarm by pushing Mute/Cancel button.

6.2.2.3 Power Information Center should read Battery icon "OK".

6.2.3 Verify unit operates while using battery power.

6.2.4 Reconnect External Power Supply and measure charging current going into
battery.

6.3 POWER UP DEFAULTS

6.3.1 With external air connected and pressurized.

6.3.1.1 Set External Air button to "OFF".

6.3.1.2 Set Peep = 4 cmH2O.

6.3.1.3 Set Sigh = “ON”.

6.3.2 Turn off unit. Turn unit back on.

6.3.2.1 External Air LCD should read "ON"

6.3.2.2 Peep = 0 cmH2O

6.3.2.3 Sigh = Off.

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6.3.3 Pressure Plateau also defaults to the Off position when the unit is first turned
on. Sigh defaults to "OFF" when Pressure Plateau is turned on.

6.4 A/C MODE

6.4.1 Control Breath

6.4.1.1 Verify in the Assist/Control mode that unit gives control breaths at the

given settings.

6.4.1.2 Use the following settings to verify the disposable ventilator circuit

mushroom inflates and deflates properly and that there is no retard of
patient exhalation. The airway pressure must reach 0 cmH2O before the
start of the next breath.

6.4.1.2.1 Resistance = 20

6.4.1.2.2 Compliance = .050 L/cmH2O

6.4.1.2.3 Rate = 20 BPM

6.4.1.2.4 I time = 1.0 sec.

6.4.1.2.5 Vt = 500 ml

6.4.1.2.6 Using compressor.

6.4.2 Assisted Breath

6.4.2.1 Put rate to 8 BPM.

6.4.2.2 Connect hose circuit to test lung.

6.4.2.3 During expiratory pause, pull up on lung to generate a negative pressure.

When a negative pressure is sensed, an assisted breath should be given at
the current settings.

6.5 SIMV

6.5.1 Control Breath

6.5.1.1 Verify in the SIMV mode that unit gives control breaths at the given

settings.

6.5.2 Assisted Breath

6.5.2.1 Put rate to 8 BPM and connect hose circuit to test lung.

6.5.2.2 During expiratory pause, pull up on lung to generate a negative pressure.

6.5.2.3 When a negative pressure is sensed in the “time window”,

6.5.2.3.1 An Assisted breath is generated

6.5.2.3.2 The inspiratory cycle is synchronized with the patient’s ventilatory

effort.

6.5.3 Demand Breath

6.5.3.1 Put rate to 8 BPM.

6.5.3.2 Connect hose circuit to test lung.