fabian Therapy Evolution Calibration and Test Instruction V11

Table of contents: 1) Configuration, PM-Kit and working hours ... 4 2) Visual inspection ... 5 3) Start-up / Self-test ... 5 4) Blender / purge flow ... 6 4.1 Blender tightness ... 6 4.2 Tightness calibration valves ... 6 5) Calibration ... 8 5.1 Set date and time ... 8 5.2 Pressure regulator calibration ... 8 5.3 Blender calibration ... 9 5.3.1 Calibration AIR valve / Flow sensor ... 10 5.3.2 Calibration O2 valve / Flow sensor ... 10 5.4 Inspiration Sensor (p insp.) ... 11 5.4.1 Pinsp 0 mbar calibration ... 11 5.4.2 Pinsp 60 mbar calibration ... 12 5.5 Proximal Sensor... 13 5.5.1 Pprox 0 mbar calibration ... 13 5.5.2 Pprox 60 mbar calibration ... 13 5.6 Touch screen calibration ... 15 5.8 Pressure relief valve calibration ... 16 5.9 O2 Sensor calibration ... 17 5.10 Flow Sensor calibration ... 17 6) O2 / Air blender ... 19 7) nCPAP Mode ... 22 8) DUOPAP Mode (if licence installed) ... 22 9) System Alarms (if module installed) ... 23 10) SPO2 functional test (if module installed) ... 23 11) Maintenance ... 24 12) Setting check ... 24 13) Safety Test Protocol ... 24 14) Battery calibration ... 24

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Test equipment Requirements: Name Calibration analyser for the measurement of: - Flow - Pressure - Oxygen Test-Set for non-intubated ventilation modes

Sample picture

Article number N/A

111292.01

Test Lung – Single Bellows

151900

Flow sensor (SPU or Reusable) Optional

151120 151111 151112 151121

Flow sensor cable - Optional

151100.01 151100.02

Masimo module (if module installed)

USB: 152401 Lemo: 152406

Masimo SpO2 tester (if module installed)

152402

Note: It is reccomended to switch on calibration analyser to allow it to warm up for 15-30 minutes before commencing the calibration and test process. Once warmed up, zero all sensors and the O2 sensor of the calibration analyser. It may be neccessary to zero sensors periodically during the course of the test process.

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1)

Configuration, PM-Kit and working hours

Adjust the Altitude settings in the Service-mode Calibration screen. Set here the proper altitude for the flow compensation. One step is 100m. After this, calibrate the flow sensor before going ahead with this instruction. If a PM was performed, document the Lot-/Serial-Nr. of the parts in the PM-Kit. Info Screen: From Main screen press 2x then INFO • • • • • • • •

Device ID Version Software Monitor PIC Conductor PIC Blender PIC Kernel Version Language Version Hours device, battery, HFO-Module

In Service mode – open Accuboard screen •

Accu PIC

All this information’s are also available when you save the “Device-Info” in the menu TOOLS. Menu point Content of the file

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2)

Visual inspection • • • •

3)

Before proceeding with calibration and functional test examine the general condition of the device. Inspect the ventilator chassis for any signs of physical damage. Inspect cabling, internal tubing and connectors for any signs of damage. Examine the exhalation membrane and cover for wear or damage, and ensure that they are correctly mounted to the device.

Start-up / Self-test / HFO Configuration Check

3.1 Power On / System Self Test • Use the ON / OFF button on fabian to power on the equipment. • When the device is powered on the start-up screen will appear and the equipment will perform a system self test. • During system self test the software revisions, the check sums and status of interfaces will be checked along with critical areas of system operation. • Confirm that the device powers up normally without unexpected alarms or errors. 3.2 Audible Alarm Test • As part of the start up procedure, following system self test you will be prompted to perform a test of the audible alarm. • Press the audio test soft key to confirm and perform the test. • The high priority audible alarm signal will be emitted. • If the alarm signal audible, confirm by pressing the Yes soft key and record the test result in the test protocol. • If the alarm signal is not audible then the device must be investigated further prior to proceeding.

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4)

Blender / purge flow

Gas standardisation: 20/1013 Gas type: Air 4.1

Blender tightness

• • • • •

4.2

Connect fabian to gas supply fabian is switched OFF Connect a tube to the middle connector “patient gas” from the blender. Place the other end in a glass filled with water OR connect to your flow meter or Respirator tester. With water it is more accurate NO bubbles coming out of the tube OR 0.00 l/min on your Respirator tester

Tightness calibration valves

• • •

•

Connect a tube to the Oxygen sensor calibration outlet. ( see picture below ) Place the other end in a drinking glass filled with water OR connect to your flow meter or Respirator tester NO bubbles coming out of the tube OR 0.00 l/min on your Respirator tester

Reconnect the tube from the blender back to its position, see white finger in picture above

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5)

Calibration

5.1

Set date and time

• 5.2

In menu date / time Pressure regulator calibration

• • • • • • •

Connect Air and O2 supply Start fabian: o In O2 Therapy mode with a setting of 3l/min of flow. Set. O2 value to 60 Vol.% Service menu -> Monitor PIC -> compare values P-AIR and P-Oxy. (Fig. 1) Adjust pressure regulator to 2400 ± 200 (Fig. 2). “Old” version. Lift the cap from the pressure regulator to adjust the value “New” version. Loosen the ring and adjust with a flat screwdriver and secure with the ring OLD Type

•

New Type

Check the values after 5 minutes again to be sure the regulator is working properly

O2

Figure 1

•

Figure 2

If adjusted secure the regulators.

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5.3

Blender calibration

5.3.1 Blender Calibration Setup

Blender calibration must be performed using a calibrated mass flow meter, IMT Analytics PF300 or Citrex, or direct equivalent. On the mass flow meter set the Gas Measurement Standard as follows: Gas standardization: 20˚C / 1013mbar Gas type: Air Power OFF the fabian ventilator. Set up for blender calibration using Citrex or PF300

Connect to Citrex main flow port Connect to fabian O2 therapy port

Connect to PF300 low flow port

Using a Y-hose fixture connect a single compressed air source to the O2 and Air Connector.

• • • • •

Connect the Air and Oxygen inlets of the fabian ventilator to a single source of compressed Air (as shown). Connect flow port of the calibration analyser to the inspiratory port of the fabian. Switch ON fabian and allow the device to complete the start up sequence. Wait until the calibration of the blender is done, silence the audible alarms as necessary through the process. Allow the fabian to run for a minimum of 5 minutes, using the appropriate group of settings shown below for the selected test method, but with O2 setting of 60%. Mode / Setting I-Flow O2 (initial)

•

O2 Therapy 10 l/min 21%

Note: Before adjusting the potentiometers it is recommended to try and restart the device 2-3 times and normally the value is coming into the range. If this is not the case, you then have to adjust the potentiometers as it is described below.

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5.3.1 Calibration AIR valve / Flow sensor Set O2: 21%

Measured Value: 9.5 ± 0.1 l/min Adjust with potentiometer 21% (Fig. 3) 5.3.2 Calibration O2 valve / Flow sensor

Set O2: 100% Measured Value: 9.5 ± 0.1 l/min Adjust with potentiometer 100% (Fig. 3)

-

+

Figure 3

Switch OFF, Switch On again. Re-check the values at 9.5 lpm for Air and O2. Recalibrate if necessary (note may require 2-3 restarts). When the calibration has been successfully completed, switch the device OFF and connect AIR / O2 as in normal use. Restart the device

5.4

Inspiration Sensor Calibration (P insp.)

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5.4.1 Accessing Inspiration Sensor Calibration • Enter fabian service mode • Initially enter the System screen and make note of the Manifold (ATG) HW version. Exit System. • Enter Monitor PIC screen. • Remove all patient tubing from the device.

5.4.2 Pinsp 0 mbar Calibration • Disconnect the inspiratory pressure tube from the manifold Ref. 3 on figures 5 and 6 and leave tubing open. • On Monitor PIC screen P-Insp / PMix should display a value in the following range ▪ 570 ±10 • P-Insp value may be adjusted using potentiometer Ref 1 on figures 5 and 6. 5.4.3 Pinsp 60 mbar Calibration • Using a tee connect calibration syringe and pressure meter to the P-insp transducer. • Apply 60 mbar to the transducer using the calibration syringe, referencing pressure meter. • On Monitor PIC screen P-Insp / P-Mix should display a value in the following range ▪ 2400 ±10 • P-Insp value may be adjusted using potentiometer Ref 2 on figures 5 and 6. • Disconnect test set-up and recconnect transducer tubing to connector Ref 3.

TS-AA-03e_V11 TI fabian +nCPAP evolution

Connect P-insp transducer on manifold PCB

Set up for P-insp calibration (60mbar) using Citrex or PF300

Connect to Citrex low pressure port

Connect to PF300 low pressure port Apply 60 mbar though calibration syringe

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Figure 5 – Old version 5.5

Figure 6 – New version

Proximal Sensor Calibration (P Prox.)

5.5.1 Preparation for Proximal Sensor Calibration • Connect the device to gas supply. • Switch the device on in normal ventilation mode. • Apply the following settings: ▪ Mode: O2 Therapy ▪ Flow: 0 l/min 5.5.2 Proximal Sensor 0 mbar Calibration • Enter fabian service mode • Enter Calibration screen. • Remove any tubing from the proximal pressure connector on the device • Press 0 mbar Cal. To initiate the calibration. • Press 0 mbar to calibrate. • Confirm 0 mbar displayed

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5.5.3 Proximal Sensor 60 mbar Calibration

Set up for P-prox calibration (60mbar) using Citrex or PF300 Connect to Prox connector on front panel

Connect to Citrex low pressure port

Connect to PF300 low pressure port Apply 60 mbar though calibration syringe

•

•

• • • •

Using a tee connect calibration syringe and pressure meter to the proximal pressure connector on the front panel. Apply 60 mbar to the proximal connector using the calibration syringe, referencing pressure meter. Press 60 mbar Cal. To initiate the calibration. Press 60 mbar to calibrate. Confirm 60 mbar displayed Note: If calibration is not successful then repeat the full process starting with 0 mbar.

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5.6

Touch Screen Calibration

• • • • •

Enter the Service menu Enter the Display screen Select Calibrate to perform the touch screen calibration Perform the calibration by touching on each calibration point accurately and in the sequence shown on the screen. When prompted on completion touch the screen within 30 seconds to save the calibration data.

•

•

5.7 Pressure Relief Valve Calibration •

•

• •

Set the device in normal operation mode with the following settings: ▪ Mode: nCPAP ▪ CPAP: 5 mbar ▪ Pmanual: 15 mbar Connect the CPAP port of the device directly to high pressure port of the pressure meter. Apply a manual breath. Safety valve must open at a measured presssure between 450-600 mbar.

Set up for safety valve calibration on Therapy using Citrex or PF300

Connect to Citrex high pressure port

Connect nCPAP port to pressure meter Connect to PF300 high pressure port

Devices with AT serial prefix

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• • • • •

5.9

• • • • •

If adjustment is required, take the following steps. Adjust safety valve by turning the calibration screw (Allen key 8 mm). Clockwise will increase pressure. Note: The screw can be very tight, because it is secured with Loctite 480. If adjustment was necessary resecuree Screw with Loctite 480 or similar.

O2 Sensor calibration

Ensure that the device is connected with medical air and oxygen before proceeding. Press the calibration button on the fabian front panel to access preuse calibration routines. Select O2 Sensor calibration. Select the 21 + 100% calibration button and 2 point calibration will be performed. In the event of a calibration failure please trouble shoot gas supply, O2 sensor etc, before proceeding with further tests.

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Calibration Screen Button

O2 Sensor calibration button

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5.10 Flow Sensor calibration (Optional) • • •

• •

Press the calibration button on the fabian front panel to re-enter the calibration routines. Make certain appopriate patient range is selected (300g – 10kg) for the neonatal flow sensor. Disconnect the flow sensor from the wye, hold firmly and firmly occlude both ends for a good calibration. Press flow cal and the calibration routine will proceed. On successful calibration the screen will be updated to show last calibration reflecting present date and time.

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Calibration Screen Button

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6)

O2 / Air Delivery Accuracy Test All tests have to be done with the Gas Standard ATP Activate also “enable O2 comp.” in “Service-Menu / Calibration”

We have adapted the gas-standard from BTPS to ATP as in the field it is easier to work without a humidifier in the system.

Set up for Air/O2 accuracy test using Citrex or PF300

Connect to Citrex main flow port

Connect to fabian O2 therapy port

Connect to PF300 high flow port

• •

• •

The O2 / Air delivery accuracy test will be performed in O2 therapy mode. To perform in O2 Therapy mode please reconfigure and connect O2 therapy port of the device to the flow inlet of calibration analyser (as shown above) and with the test lung removed. Apply the following settings on the device and record the measured values in turn for each of the O2 test cases on the test protocol. If necessary, recalibrate the O2 sensor for the devices and calibration analyser.

Model/ Setting I-Flow O2 (Test 1) O2 (Test 2) O2 (Test 3) O2 (Test 4)

O2 Therapy 5 l/min 21% 40% 60% 100%

7) nCPAP Mode Tests TS-AA-03e_V11 TI fabian +nCPAP evolution

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•

To perform the nCPAP modes test, connect Test Set 2 to the device, with the Wye in the proximal line connected to the low pressure port of PF300 or Citrex (as shown below).

Connect Prox Line to low pressure (rear connection on Citrex) Prox Line

Drive Line

Wye

Exhaust Test Set 2

Set Up for nCPAP & DuoPAP Tests with PF300 or Citrex •

Apply the following setting changes in turn for each test case on the unit under test and record the relevant values (Pmean) on the test protocol. Mode

nCPAP Pressure

Oxygen

Man Breath

nCPAP

5 mbar

21 Vol %

15 mbar

nCPAP

10 mbar

21 Vol %

15 mbar

8) DUOPAP Mode Tests • •

DUOPAP Mode tests will use Test Set 2 configured as shown above with the Wye in the proximal line connected to the low pressure port of PF300 or Citrex. Configure the calibration analyser with Ventilations parameter pressure source (settings > measurements) to Pressure Difference

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•

•

• •

Configure the unit under test with the following initial settings: Mode

DuoPAP

CPAP

10 l/min

PDuo

5 l/min

Frequency

10 bpm

I-Time

2.00 sec

Oxygen

21 Vol %

Configure the calibration analyser with the following initial Trigger settings: Trigger Type

Paediatric

Trigger Source

Internal Flow (Low)

Start Condition

Pressure (in flow), 5 mbar, positive edge

Stop Condition

Pressure (in flow), 5 mbar, negative edge

Delay

10 ms

Work through the 3 test cases shown below, adjusting ventilator settings and calibration analyser settings as directed. Record values for Ppeak, Pmean, PEEP in test protocol TS-FB-12e. Device Settings

Calibration Analyser Settings

Set CPAP

Set P-DUO

Start Condition

Stop Condition

Test Case 1

3 mbar

8 mbar

5 mbar

5 mbar

Test Case 2

5 mbar

10 mbar

7 mbar

7 mbar

Test Case 3

10 mbar

15 mbar

12 mbar

12 mbar

9) System Alarm Tests • • • •

Disconnect the Oxygen high pressure hose from source. Verify Oxygen Supply Pressure high priority alarm is displayed on the device. Reconnect the Oxygen high pressure hose to source. Verify Oxygen Supply Pressure alarm has been reset. Disconnect the Air high pressure hose from source. Verify Air Supply Pressure high priority alarm is displayed on the device Reconnect the Air high pressure hose to source. Verify Air Supply Pressure alarm has been reset.

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• • • •

Disconnect inspiratory tube from the device, verify Disconnect high priority alarm is displayed on the device. Reconnect inspiratory tube to the device, verify the Disconnect alarm has been reset. Disconnect the proximal pressure tube from the device, verify that the Disconnect high priority alarm is displayed on the device. Reconnect the proximal pressure tube to the device, verify that the Disconnect alarm has been reset.

10) SPO2 Functional Check • •

If the device is equipped with SPO2 Measurement function then this additionally must be functionally test as follows: Firstly identify the hardware generation of the device by observing the rear panel. Newer 4th edition devices have a Lemo type connector labelled for SPO2, all older devices have a USB type connector labelled for SPO2 as shown below:

4th edition Lemo – Use 152406 • • •

(if module installed)

Legacy USB – Use 152401

Connect the appropriate version of SPO2 module to the SPO2 connector at the rear of the device (if available use customer module), connect to it the Masimo SPO2 simulator. Navigate to the calibration screen on the user interface and enable the SPO2 function by pressing the SPO2 button. Adjust user interface to display SPO2 measurements screen, and verify the that displayed values are within defined ranges below:

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Parameter

•

Simulator (preset)

Measured Value

SPO2

81 %

X % ±3%

PR

61 bpm

X bpm ± 1 bpm

When the test has been completed, switch off the SPO2 sensor and disconnect the SPO2 module and simulator

11 Set Maintenance Date •

• • •

If calibration and functional test have been performed following execution of preventive maintenance, then it is recommended to set a “Next Service Date” to correspond with the anniversary of the service date. Enter the service mode and access the Maintenance screen. Press the button to enable “Next service date” and set the date to match the anniversary of the date of service. The user will observe the icon shown on the alert bar of the device with effect from 30 days in advance of the next service date.

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