Has electrical safety

2 years

Replacement of internal battery pack.

1 year

Replacement of high-pressure inlet filters.

Replacement of the internal oxygen sensor.

Cleaning and Inspection – Inspect the ventilator’s fan inlet filter.

Cleaning and Inspection – Verify that the air and oxygen fittings and water traps are securely attached to
the ventilator.

Cleaning and Inspection – Inspect the inlet filters for excessive discoloration.

Cleaning and Inspection – Inspect the ventilator chassis for cleanliness.

Cleaning and Inspection – Visually inspect the ventilator’s interior and exterior for any obvious problems
such as missing or broken parts; loose assemblies, disconnected wires, connectors or tubes.

Test Equipment Set Up – Check each device is in full working order and, as appropriate, they hold valid
calibration certificates.

Performance Testing – Verify that you have followed all procedures correctly, and that all required
settings are correct, before attempting to perform any repairs on the device.

Perform the Fabrication Test 5 – Sensor Adjust.

Perform the Performance Verification Tests – Pneumatic Analyzer.

Perform the Performance Verification Tests – Unit Under Test (UUT) Configuration.

Perform the Performance Verification Tests – Unit Under Test (UUT) Set-Up.

Performance Test 1 – Gas Volume Accuracy (Vt / Vte / RR) – Infant Volume Check – Verify the machine
cycles with no alarms.

Performance Test 1 – Gas Volume Accuracy (Vt / Vte / RR) – Infant Volume Check – Verify the delivered
tidal volume (Vti) is in the range 20ml ± 3ml.

Performance Test 1 – Gas Volume Accuracy (Vt / Vte / RR) – Infant Volume Check – Verify the exhaled
tidal volume (Vte) is in the range 20ml ± 3ml.
Performance Test 1 – Gas Volume Accuracy (Vt / Vte / RR) – Infant Volume Check – Verify the delivered
respiratory rate (Rate) in the range 39.5-40.5 b/min.

Performance Test 1 – Gas Volume Accuracy (Vt / Vte / RR) – Pediatric Volume Check – Verify the
delivered tidal volume (Vti) is in the range 100ml ± 15ml.

Performance Test 1 – Gas Volume Accuracy (Vt / Vte / RR) – Pediatric Volume Check – Verify the exhaled
tidal volume (Vte) is in the range 100ml ± 15ml.

Performance Test 1 – Gas Volume Accuracy (Vt / Vte / RR) – Pediatric Volume Check – Verify the
delivered respiratory rate (Rate) in the range 29.6-30.4 b/min.

Performance Test 1 – Gas Volume Accuracy (Vt / Vte / RR) – Adult Volume Check – Verify the delivered
tidal volume (Vti) is in the range 300ml ± 25ml.

Performance Test 1 – Gas Volume Accuracy (Vt / Vte / RR) – Adult Volume Check – Verify the exhaled
tidal volume (Vte) is in the range 300ml ± 25ml.

Performance Test 1 – Gas Volume Accuracy (Vt / Vte / RR) – Adult Volume Check – Verify the delivered
respiratory rate (Rate) in the range 19.7-20.3 b/min.

Performance Test 1 – Gas Volume Accuracy (Vt / Vte / RR) – Adult Volume Check – Verify the delivered
tidal volume (Vti) is in the range 600ml ± 40ml.

Performance Test 1 – Gas Volume Accuracy (Vt / Vte / RR) – Adult Volume Check – Verify the exhaled
tidal volume (Vte) is in the range 600ml ± 40ml.

Performance Test 1 – Gas Volume Accuracy (Vt / Vte / RR) – Adult Volume Check – Verify the delivered
respiratory rate (Rate) in the range 14.75-15.25 b/min.

Performance Test 1 – Gas Volume Accuracy (Vt / Vte / RR) – Adult Volume Check – Verify the delivered
tidal volume (Vti) is in the range 1000ml ± 60ml.

Performance Test 1 – Gas Volume Accuracy (Vt / Vte / RR) – Adult Volume Check – Verify the exhaled
tidal volume (Vte) is in the range 1000ml ± 60ml.

Performance Test 1 – Gas Volume Accuracy (Vt / Vte / RR) – Adult Volume Check – Verify the delivered
respiratory rate (Rate) in the range 7.82-8.18 b/min.

Performance Test 1 – Gas Volume Accuracy (Vt / Vte / RR) – Adult Volume Check – Verify that after 20
normal cycles the device delivers 5 consecutive breaths at sigh volume.

Performance Test 1 – Gas Volume Accuracy (Vt / Vte / RR) – Adult Volume Check – Verify that on the 5th
of 5 consecutive sigh breaths the volume delivered is in the range 702.5-797.5 ml.

Performance Test 1 – Gas Volume Accuracy (Vt / Vte / RR) – Adult Volume Check – Verify the Vte
reading is in the range 702.5-797.5 ml.

Performance Test 2 – Pressure Accuracy (Pcontrol/PEEP) – Pressure Checks – Verify that it is in the range
10cmH2O ± 2.25cmH2O.
Performance Test 2 – Pressure Accuracy (Pcontrol/PEEP) – Pressure Checks – Verify that it is in the range
50cmH2O ± 3.25cmH2O.

Performance Test 2 – Pressure Accuracy (Pcontrol/PEEP) – Pressure Checks – Verify that after 20 normal
cycles the device delivers 5 consecutive breaths at sigh pressure.

Performance Test 2 – Pressure Accuracy (Pcontrol/PEEP) – Pressure Checks – Verify a peak pressure
during inspiration of 15cmH20 ± 2.375cmH2O.

Performance Test 2 – Pressure Accuracy (Pcontrol/PEEP) – Pressure Checks – Verify the reading is in the
range 5cmH2O ± 2.2cmH2O.

Performance Test 2 – Pressure Accuracy (Pcontrol/PEEP) – Pressure Checks – Verify the reading is in the
range 30cmH2O ± 3.2cmH2O.

Performance Test 2 – Pressure Accuracy (Pcontrol/PEEP) – Pressure Checks – Verify the reading is in the
range 50cmH2O ± 4.0cmH2O.

Performance Test 3 – Oxygen Delivery Accuracy – Verify the O2 reading on the test monitor is 21% ± 3%.

Performance Test 3 – Oxygen Delivery Accuracy – Verify the O2 reading on the UUT is 21% ± 6%.

Performance Test 3 – Oxygen Delivery Accuracy – Verify the monitored O2 reading on the test monitor is
60% ± 3%.

Performance Test 3 – Oxygen Delivery Accuracy – Verify the O2 reading on the UUT is 60% ± 6%.

Performance Test 3 – Oxygen Delivery Accuracy – Verify the O2 reading on the test monitor is 100% ±
3%.

Performance Test 3 – Oxygen Delivery Accuracy – Verify the O2 reading on the UUT is 100% ± 6%.

Performance Test 4 – Alarm Operation – Verify, that after a small number of breaths the high priority
audible alarm is enunciated.

Performance Test 4 – Alarm Operation – Verify that it is accompanied by a flashing alarm LED and the
Disconnect alarm message is visible on screen.

Performance Test 4 – Alarm Operation – Verify that, by pressing the Alarm Mute button only once; the
audible alarm is silenced but the visual alarm indicators remain active.

Performance Test 4 – Alarm Operation – Verify that, by pressing the Alarm Mute button again, the
audible alarm is active once more and the visual alarm indicators remain active.

Performance Test 4 – Alarm Operation – Verify that, by pressing the Alarm Mute button once again, the
audible alarm is silenced and after a period of 108-132 seconds is active once more.

Performance Test 4 – Alarm Operation – Verify the Disconnect and all appended alarm conditions cancel
after a number of breaths.

Performance Test 4 – Alarm Operation – Verify, that after a small number of breaths the high priority
audible alarm is ennunciated.
Performance Test 4 – Alarm Operation – Verify it is accompanied by a flashing alarm LED, the High
Pressure alarm message is visible on screen and that breath delivery truncates upon hitting the high
pressure alarm limit.

Performance Test 4 – Alarm Operation – Verify, that after a small number of breaths all alarm conditions
auto reset.

Performance Test 4 – Alarm Operation – Verify that after a period of 17-23 seconds a high priority
audible alarm is enunciated and it is accompanied by the alarm LED and an Apnea alarm message on the
screen

Performance Test 4 – Alarm Operation – Verify that apnea back up ventilation has been initiated at the
settings programmed from the table above.

Performance Test 4 – Alarm Operation – Verify that apnea back ventilation discontinues and that SPONT
mode is restored.

Performance Test 5 – Gas Sources – Verify that, after a number of cycles, a medium priority alarm is
enunciated and that it is accompanied by a flashing alarm LED and an Oxygen Supply alarm message.

Performance Test 5 – Gas Sources – Verify that ventilation continues uninterrupted.

Performance Test 5 – Gas Sources – Verify that a high priority alarm is enunciated and it is accompanied
by a flashing alarm LED and a Low Oxygen alarm message.

Performance Test 5 – Gas Sources – Verify that ventilation continues uninterrupted. (repeated)

Performance Test 5 – Gas Sources – Verify that after a number of breaths each of the above alarm
conditions reset.

Units with Internal Compressor Only – Verify that a medium priority air supply alarm is enunciated after
which the internal compressor system starts.

Units with Internal Compressor Only – Verify also that an information message FIO2 and delivery can
vary is displayed on screen.

Units with Internal Compressor Only – Verify the internal compressor system ceases to operate and any
alarms reset.

All Units – Verify that a medium priority alarm is enunciated and that it is accompanied by a flashing
alarm LED and an Air Supply alarm message.

All Units – Verify that ventilation continues uninterrupted.

All Units – Verify that a high priority alarm is enunciated and that it is accompanied by a flashing alarm
LED and a High Oxygen alarm message.

All Units – Verify that ventilation continues uninterrupted.

All Units – Verify that after a number of breaths a high priority Internal Pressure Low alarm message is
displayed, and that after a further number of breaths breath delivery ceases.
All Units – Verify that breath delivery is restored and that all alarms conditions reset.