fabian HFO Calibration and Test Instructions V06

Table of contents: 1) Configuration 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 4.3 Purge flow ... 7 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 5.7 Exhalation valve calibration ... 15 5.8 Pressure relief valve calibration ... 16 5.9 O2 Sensor calibration ... 17 5.10 Flow Sensor calibration ... 17 6) Functional test ... 18 7) Trigger Check ... 19 8) Volume guarantee Check (if licence installed)... 19 9) O2 / Air blender ... 19 10) HFO ... 20 11) Patient alarms ... 21 11.1 Tube leak and Apnea ... 21 11.2 ET tube check ... 21 11.3 Pressure high ... 21 12) System Alarms... 22 13) CPAP Mode ... 22 14) DUOPAP Mode (if licence installed) ... 22 15) SpO2 functional test (if module installed) ... 23 16) etCO2 functional test (if module installed) ... 23 17) Maintenance ... 24 18) Setting check ... 24 19) Safety Test Protocol ... 24 20) Battery calibration ... 25

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Used Test equipment: Calibrated tester for: • • •

Flow measurement Pressure measurement Oxygen measurement

Test-Set for intubated ventilation modes Part No. 7398 / 111291 Test Set1

Test-Set for non-intubated ventilation modes Part No. 7398.N / 111292 Test Set2

Test lung Part No. 1116 / 151901

Test lung small Part No. 7204 / 151900

Flowsensor Part No. 1031 / 151120

Flowsensor cable Part No. 1016 / 151100.xx

SpO2 Tester, Part. No. 152402

(if module installed)

etCO2 unit, e.g. Micro Pod Binder Part No: 7227.B / 152301

(if module installed)

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1)

Configuration 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 flowsensor before going ahead with this instruction. 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

Inspect the device for general condition. 3)

Start-up / 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 self-test The SOFTWARE REVISION, the CHECK SUMS and the status of the interfaces will be checked (ok ≙ no error)

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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 and block the lowest tube of the blender, “Purge flow”. See picture below 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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4.3

Purge flow

• •

Connect a tube to the proximal sensor port. (see picture below) Switch ON fabian

Settings: Mode I - Flow E - Flow PEEP P Insp Frequency I - Time Oxygen •

•

IPPV 8 l/min 5 l/min 5 mbar 30 mbar 30 bpm 1.00 sec. 21 Vol.%

Connect your flow meter or respirator tester to the prox. port. ( see picture below ) Start manual inspiration by pressing: Reading on the tester between 150 and 350 ml/min

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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, if not available use o IPPV mode with I-Flow 3l/min 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

Air Figure 1

•

Figure 2

If adjusted secure the regulators.

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5.3

Blender calibration

Calibration must be done by a calibrated mass flow meter Power OFF the device The measurement unit must set to the following setting: Gas standardisation: 20 oC / 1013 mbar Gas type: Air

Supply Air and O2 connection with compressed air!

• • • •

Connect the flowmeter to the inspiratory port of the fabian Switch ON fabian Wait until the calibration of the blender is done! Quit the Alarm from the 100% calibration! Let the fabian run for 5 minutes with an O2 saturation of 60%

Settings: Mode

IPPV

O2 Therapy

I - Flow

10 l/min

10 l/min

E - Flow

5 l/min

PEEP

5 mbar

P Insp

30 mbar

Frequency

10 bpm

I - Time

2.00 sec.

O2

21 Vol.%

21 Vol.%

O2-Flush

100 Vol.%

100 Vol.%

Set the manual Breath time to the maximum of 30 Seconds. See Settings menu on the left side or in the Ventilation menu •

You can Switch OFF all Alarms by pressing Simultaneously

and

, hold for approx. 5 sec

In the upper right corner, the symbol will appear From now on ALL alarms are disabled until restart of the Unit

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Before adjusting the potentiometers try to 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. 5.3.1

Calibration AIR valve / Flow sensor

Set O2: 21% Reading: 9.5 ± 0.1 l/min Adjust with potentiometer 21% (Fig. 3) For IPPV-Mode you have to press and hold the button for “manual breath” 5.3.2

Calibration O2 valve / Flow sensor

Activate the O2 Flush (100%) Reading: 9.5 ± 0.1 l/min Adjust with potentiometer 100% (Fig. 3) For IPPV-Mode you have to press and hold the button for “manual breath”

-

+

Figure 3

• • • •

Switch OFF fabian Switch ON fabian Compare the values 9.5 l/min for AIR and O2 Possibly recalibrate (sometimes need 2 or 3 restarts)

When the calibration is done, power OFF the device and connect AIR / O 2 as in normal use. Restart the device

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5.4

Inspiration Sensor (p insp.)

5.4.1 Pinsp 0 mbar calibration • fabian Service Mode • Monitor PIC • Disconnect the tube from the manifold (Fig. 5, mark 2)

• No patient tubing connected. • Value p-insp for: HW 1 - 3: 1480 ± 10 HW 4: 1095 ± 10 ( Fig. 4) 1095

• Adjust with potentiometer ( Fig. 5, mark 9 )

Figure 4

The information for the hardware of the manifold can be found in the „ServiceMenu / System“ ATG: or in the „Device-Info“ file.

SN prefix 20-, AH-, AK-

SN prefix AI-, AL-

Figure 5 TS-AA-17e V06 TI fabian HFO

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5.4.2

Pinsp 60 mbar calibration

• Apply 60mbar to the disconnected tube from the manifold (Fig. 7, mark 2) • Value p-insp for: HW 1 - 3: 2940 ± 10 HW 4: 2255 ± 10 ( Fig. 6 )

2255

• Adjust with potentiometer ( Fig. 5, mark 8 ) Figure 6

•

Connect the tube again to the manifold (Fig 5, tube from mark 2 to mark 10)

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5.5

Proximal Sensor Before you start the calibration, do the following: - Connect gas supply - Ventilation Mode: select CPAP - Setting: CPAP = 5mbar, Flow = 4l/min

Figure 7

5.5.1

• • • •

Pprox 0 mbar calibration Service menu -> calibration Prox. Port is open / no tube connected Press – Calibrate Confirm 0 mbar

5.5.2 Pprox 60 mbar calibration There are two ways to perform the 60 mbar calibration. Option A is the recommended way once the device is open. In cases when the device is not open, the 60 mbar calibration can be done without opening it by following Option B. 5.5.2.1 Option A

• • • •

Connect calibration set on prox. port. ( Fig. 7 ) Set 60 mbar on prox. port Confirm 60 mbar button Sensor is calibrated

If the measurement can’t be done, you have to block the lowest tube of the blender, “Purge flow”

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5.5.2.2 Option B

• • • •

• • • •

Connect “Test Set 1” and test lung „ small „ Connect measurement device with T Piece (Prox. port) Press 60 mbar Cal. Confirm the next message

Keep the “manual breath” button pushed Check the external pressure Release the “manual breath” button Adjust the difference with +/-, you can use the buttons or the knob. You have to confirm the value. As long the value is “green” it is not taken, it has to be dark blue.

• • • • •

Redo a “manual breath” Check the external pressure Adjust the difference with +/Redo a “manual breath” When the pressure is okay on the external device, push the SAVE button during the “manual breath” • Now the calibration is stored. Redo the whole procedure until you get a stable value with a maximal difference of 0.2mbar.

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5.6

Touch screen calibration

• • • •

5.7

Service menu Display Calibration Follow messages on the screen (possibly you must perform the calibration more than one time!)

Exhalation valve calibration • • •

Connect fabian to gas supply Service mode - > calibration Connect “Test Set1”

•

Exhalation valve calibration

•

Follow messages on the screen Be sure to have the test lung removed from the Y Piece. Hold Y Piece tight

•

When the values show p peak / PIP 50 mbar ± 1 and PEEP 5mbar ± 0.5 push the “Home button” data

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to store the calibration

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5.8

Pressure relief valve calibration

•

Start fabian in nCPAP mode Set CPAP 5 mbar Set P manual 15 mbar Connect pressure gauge ( range 0 - 1 bar ) directly to the CPAP port .( Fig. 8 )

• •

•

SN prefix 20-, AH-, AK-

CPAP

SN prefix AI-, AL-

CPAP

Figure 8

• • • •

•

Apply manual breath Safety valve opens between 450 to 600 mbar Adjust safety valve by turning the calibration screw (Allen key 8 mm) Clockwise will increase pressure (Fig. 9) REMARK: The screw can be very strong, because it is secured with Loctite 480 Secure Screw with Loctite 480 or similar

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Figure 9

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5.9

O2 Sensor calibration

Access the calibration menu directly via the calibration key: Start the calibration with pressing 21+100%

5.10 Flow Sensor calibration

First you have to go into the “IPPV” mode. Go into the calibration menu directly via the calibration key: Ensure no gas will flow through the flow sensor during calibration. The best way is to hold both sides tighten with your fingers.

Following successful calibration, the date of the last calibration will be displayed in the corresponding field.

Close the device now. All the tests have to be done with a closed device to be sure that no cables or tubes are kinked.

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6)

Functional test All tests have to be done with the Gas Standard ATP Activate also “enable O2 comp.” in “Service-Menu / Calibration” and also to have the correction factors for flow sensors to 0.960

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. Connect “Test Set 1” and test lung „ small „

Trigger settings for the measurement device, e.g. Flow Analyser PF-300 are:

0.2

-0.2

The “Test Set 1” with small lung has to be connected in the “low flow” line of the tester. The test settings are then shown in the “TS-FB-27e V06 TI fabian HFO” protocol

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7)

Trigger Check

Use the following settings for the test: Mode

S - IPPV

Trigger

5

I - Flow

8 l/min

E - Flow

5 l/min

PEEP

5 mbar

P Insp

15 mbar

Frequenz

15 bpm

I - Time

2.00 sec.

Oxygen

21 Vol.%

At Expiration phase pull the test lung small to initiate a trigger If a trigger is applied the breathing curve will turn green 8)

Volume guarantee Check

(if licence installed)

Connect test tube set and test lung „ small „ Set the Patient range to Neonatal (Ventilation Mode) and calibrate the flowsensor Important: The leakage must be 0, otherwise the measurements are different Use the following settings for the test: Mode

IPPV

I - Flow

6 l/min

E - Flow

6 l/min

PEEP

5 mbar

P Insp

25 mbar

Pmax

35 mbar

I - Time

1.00 sec.

Frequenz

30 bpm

If you do not pass this test, try it with another flow sensor. Most of the time the flow sensor is causing the problem At the end of this test, set VG off 9)

O2 / Air blender

Use the following settings for the test: Mode

IPPV

O2 Therapy

I - Flow

5 l/min

5 l/min

E - Flow

5 l/min

PEEP

5 mbar

CPAP

-

P Insp

20 mbar

P duo I - Time

0.5 sec.

Frequenz

60 bpm

In O2 Therapy you can connect only the flow tube. For IPPV connect “Test Set1” without lung direct to the insp. port of the fabian

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10) HFO Connect “Test Set1” and test lung „ small „ HFO-Mode, Screen 2/3

SN prefix 20-, AH-, AK-

SN prefix AI-, AL-

Trigger settings for the measurement device, e.g. Flow Analyser PF-300 are:

3.00

3.00

The “Test Set1” with small lung has to be connected in the “high flow” line of the tester Use the following settings for the test: Mode

HFO

Flow

5

I:E

1:1

O2

21 Vol. %

The test settings are then shown in the “TS-FB-27e V06 TI fabian HFO” protocol

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