CCV: Functional Checks During Installation

The following checks are intended to verify that a newly-installed Gradian CCV is functioning correctly
and ready for clinical use. The procedure below should be followed during installation, and the outcome
recorded on the provided form.

Setup Procedure:

1. Attach a silicone breathing circuit to the Gradian CCV, and ensure that the exhalation
valve is properly assembled.
2. Attach a test lung to the end of the breathing circuit.
3. Plug the CCV into mains power.
4. Turn the CCV on and set it to “Volume AC” mode with the following parameters: Vt =
500 ml, It = 2.00, BPM = 10, High Pressure Alarm = 55, Low Pressure Alarm = 5, %O2 =
21.
5. Allow the CCV to run for a full minute, until the test lung is full and no alarms are
sounding. Press the red Alarm Silence/Reset button to clear any alarms that had been
activated.
6. Connect the CCV to the facility’s preferred high-concentration oxygen source (cylinder,
pipeline, or concentrator).

Custom Mode Initialization

1. Press the Adult Quick Start button mode twice, and confirm that the CCV begins
operating in the Adult Quick Start Mode (the blue light underneath the button is solid).
If the ventilator beeps and does not enter the Adult Quick Start mode, the mode has not
been initialized.
2. Repeat for the Child Quick Start mode.
3. Press Custom Mode Selection, and use the Parameter/Mode Adjustment arrows to
select Custom Mode #1, then press Custom Mode Selection again. Verify that the
ventilator begins operating in Custom Mode #1.
4. Repeat for Custom Mode #2 and #3.

External Battery Pack

1. Connect the external battery pack to the CCV, and verify that the “External Batt. Power
Connected When Lit” light is illuminated.
2. Disconnect the external battery pack from the CCV, and confirm that both the external
battery pack and CCV internal battery are charging.
%O2:

1. With the %O2 set at 21, verify that the internal compressor is running. If an oxygen
analyzer is available, measure and record the output oxygen concentration.
2. Set the %O2 to 100 (if possible with the available oxygen sources) and verify that the internal
compressor is no longer running. If an oxygen analyzer is available, measure and record the
output oxygen concentration.
3. Set the %O2 back to 21.

High Pressure Alarm (HPA)

1. Verify that the general alarm indicator light is not illuminated, and that no alarm lights
are illuminated. If any alarm lights are illuminated, press the red Alarm Silence/Reset
button and ensure no alarms are currently active.
2. Remove the test lung and cover the output of the patient circuit with your thumb.
3. Verify that the audible and visual alarm indicators are activated, and that the HPA
individual indicator light is illuminated.
4. Replace the test lung on the breathing circuit and verify that the audible and visual
indicators are deactivated, but that the HPA individual indicator light remains
illuminated.
5. Press the red Alarm Silence/Reset button to clear the alarm, and verify that the
individual indicator light is no longer illuminated.

Low Pressure Alarm (LPA)

1. Disconnect the test lung from patient circuit and verify that the audible and visual alarm
indicators and individual LPA alarm light are activated.
2. Reconnect the test lung to the patient circuit.
3. Press the red Alarm Silence/Reset button to clear the alarm.

Low O2 Source Alarm

Note: If no high-pressure oxygen source is available, skip this test

1. Set the %O2 to 100.

2. Shut off the O2 source gas and verify that the Low O2 source alarm, audible alarm and
general alarm indicator are activated.
3. Turn the O2 source back on.
4. Set the %O2 back to 21.
5. Press the red “Alarm Silence/Reset” button to clear the alarm.

Operation With a Concentrator

Note: If no oxygen concentrator is available, skip this test
 1. Attach a concentrator to the CCV reservoir, and attach the reservoir to the CCV with the
green high-flow oxygen hose.
2. Turn the concentrator on and set the flow to its maximum setting.
3. Press O2 Conserve Mode and verify that the indicator light is illuminated.
4. Increase the %O2 until the red light labeled “” is illuminated. Decrease the %O2 by one
(1) and verify that the red light goes off.
5. Shut off the concentrator and verify that the Low O2 source alarm, audible alarm and
general alarm indicator are activated.
6. Set the %O2 back to 21.
7. Press the red “Alarm Silence/Reset” button to clear the alarm.

Apnea Alarm

1. Set BPM to 0.
2. Verify that the Apnea alarm is activated after approximately 20 seconds, and that the
ventilator changes to “Pressure AC” mode and delivers a breath.
3. Draw negative pressure through the breathing circuit to trigger a breath two times, and
verify that the ventilator returns to the previous settings.
4. Set the BPM back to 10.

Excessive Patient Circuit Leak

1. Set the ventilator to “Pressure AC” mode, It = 2.0, BPM = 10, %02 = 21, PIP = 40, PEEP =
0, HPA = 55, LPA = 5.
2. Disconnect the test lung from the breathing circuit, and cover the circuit output partially
with your thumb so that the LPA is not triggered but so that the PIP stays below 30.
3. Monitor that the “Delivered Tidal Volume” is increasing with each subsequent breath.
4. Verify that in 4 or 5 breaths, after flow exceeds 60 LPM (and PIP has not reached 30),
that the “Excessive Patient Circuit Leak” LED, audible alarm and general alarm indicator
are active. (This test may take approximately 15 to 20 breaths.)
5. Reattach the test lung to the breathing circuit, and verify that the alarm clears in
approximately 5 to 10 breaths.

Continuous Positive Airway Pressure (CPAP)

1. Put the ventilator in CPAP mode, and set PEEP/CPAP to 8 cmH2O.

2. Verify that the displayed PIP on the ventilator is between 6 and 10 cmH2O.
3. Set the PEEP/CPAP to 15 cmH2O.
4. Verify that the displayed PIP is between 13 and 17 cmH2O.

Manual Breath

1. Set the ventilator to Volume AC mode with the following parameters, Vt = 500 ml, It =
2.00, BPM = 5, %O2 = 21.
 2. Press the “Manual Breath” button, and verify the “Manual Breath” LED lights briefly and
a breath is delivered.

Spontaneous Trigger

1. Draw negative pressure through the breathing circuit and verify that the “Spontaneous
Breath LED” light illuminates briefly and a breath is delivered.

Pressure Control

1. Set the ventilator to “Pressure AC” ventilation mode, with It = 2.00, BPM = 10, PEEP = 0,
PIP = 15, HPA = 55, LPA = 5 and %O2 = 21.
2. Verify that the ventilator’s displayed “PIP” pressure is between 13 and 17 cmH2O.
3. Change the PIP setting to 30, and verify that the ventilator’s displayed “PIP” pressure is
between 27 and 33 cmH2O.
4. Change the PIP setting to 50, and verify that the ventilator’s displayed “PIP” pressure is
between 45 and 55 cmH2O.

Tidal Volume, Inspiratory Time and BPM

1. Set the ventilator to “Volume AC” mode, LPA = 5, HPA = 55, %O2 = 60 (or as close as
possible with the oxygen sources available).
2. Set the ventilator to the settings detailed in Test 1 on the CCV Functional Check Report.
3. Allow the ventilator to run for 30 seconds.
4. Using a watch, count the number of breaths delivered in one minute, and record under
“Measured BPM”.
5. Once the ventilator output has stabilized (after roughly 10 breaths), record the delivered
tidal volume under “Delivered Vt”.
6. If both measured values fall within their respective allowable ranges, mark “Pass”.
Otherwise, write “Fail”.
7. Repeat for the remaining test configurations.

CCV Functional Check Report

Health Facility Name: ________________________________

Ventilator Serial Number: _________________________________

Ventilator Location Within Facility: _______________________________

Primary and Secondary Oxygen Sources: _______________________________

Setup & Ventilator Checks
Test Pass/Fail Notes
Handle, Hooks, Stand Plate Installed
Breathing Circuits & HMEs Present
Condition of Stand & Cables
Air Filter Installed & Clean
Custom Mode Initialization
External Battery Pack
%O2
High Pressure Alarm
Low Pressure Alarm
Low O2 Source Alarm
Operation With a Concentrator
Apnea Alarm
Excessive Patient Circuit Leak
CPAP
Manual Breath
Spontaneous Trigger
Pressure Control

Tidal Volume, Inspiratory Time and BPM

Delivered Vt
Test Ti Set BPM BPM Range Measured BPM Set Vt Vt Range Displayed / Measured Pass/Fail
1 2 10 9 to 11 2000 1800 - 2200 /
2 1.5 20 18 to 22 1250 1125 - 1375 /
3 1 30 27 to 33 675 607 - 743 /
4 0.75 40 36 to 44 375 337 - 413 /
5 0.75 40 36 to 44 250 225 - 275 /
6 0.5 50 45 to 55 100 90 - 110 /
7 0.5 60 54 to 66 40 30 - 50 /

Technician Name: ___________ Hospital Personnel Name: _______________

Technician Signature: __________ Hospital Personnel Signature: ____________

Date: _______ Date: _______