fabian HFO Service Manual Rev 2.10 April 2019

Table of Contents

Table of Contents Sales and Service Information ... 2 Table of Contents... 3 1

Preface ... 6

1.1

Document Structure ...6

1.2

List of abbreviations ...7

1.3

Service manual revision history ...7

2

Hardware and Software information... 8

2.1

Serial number description ...8

2.2

Hardware and Software version on Service Sticker ...8

2.3

Hardware Revision History ...9

3

Important preliminary remarks ...10

3.1 3.2

ESD Precautions ... 10 Warranty ... 10

3.3

Liability for functionality/ damages ... 10

3.4 3.5

Service, Repair, Maintenance, Calibration & Testing ... 11 Contact ... 11

4

System overview...12

4.1

Manifold user side ... 13

4.2

Rear panel ... 14

4.2.1 4.2.2

External alarm connector (Nurse call)... 15 Connector for 12 - 24 VDC ... 15

4.3

Hardware components ... 16

4.3.1 4.3.2 4.3.3 4.3.4 4.3.5 4.3.6

Mainboard ... 16 NetDCU ... 20 Power module ... 21 Manifold ... 24 HFO module... 26 Proportional gas blender with the O2 sensor ... 28

4.4

Internal tubing ... 32

4.5

PDMS/ Network/ acuLink connection ... 33

fabian HFO | SM-Rev. 2.10 Ref: 113010.03EN / Date: 24.04.2019

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Table of Contents

5

Failure analysis ...34

5.1

Alarm messages on device ... 34

5.2

Power PCB - status LEDs and fuses ... 36

5.3

Mainboard – watchdog LEDs ... 37

5.4 5.5

Software Watchdog ... 38 Alarm messages about the Proportional Gas Blender ... 38

5.6

Trends, Log files, Device info ... 40

6

Calibration and Service information ...46

6.1 6.2

Battery calibration ... 47 System and service information ... 47

6.3

Calibration submenu ... 51

6.4

Blenderboard submenu ... 52

6.5 6.6

MonitorPIC submenu ... 53 Valves submenu ... 54

6.7

Display submenu ... 55

6.8 6.9

Settings submenu ... 57 Licensing submenu and License handling ... 60

6.10

Maintenance submenu ... 63

7

Software Information ...65

8

Servicing ...66

8.1

Cleaning and disinfection... 66

8.2

Transportation ... 66

8.3

List of test equipments and special tools ... 66

8.4

Alarms off ... 67

8.5

Service password off ... 67

8.6

Spare parts list ... 67

8.7

Handling of the used components... 67

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fabian HFO | SM-Rev. 2.10 Ref: 113010.03EN / Date: 24.04.2019

Table of Contents

9

Repair and various replacements/ Disassembly and assembly ...68

9.1

Expiratory membrane ... 69

9.2

Proximal connector ... 70

9.3

User knob ... 70

9.4 9.5

Main fuses (Power inlet module) ... 71 Housing removal (open the device) ... 72

9.5.1 9.5.2 9.5.3 9.5.4 9.5.5 9.5.6 9.5.7

Internal battery (Powerpack/ Batterypack) ... 77 Power PCB ... 79 Flow sensor connector PCB... 81 Proportional Gas Blender with O2 sensor... 84 Mainboard ... 94 NetDCU ... 98 HFO module – Membrane exchange ... 101

9.6

Complete Front Panel removal... 109

9.6.1 9.6.2

Encoder ... 111 LCD Display ... 112

9.7 9.8

Manifold ... 113 Rear panel removal ... 114

9.8.1 9.8.2 9.8.3 9.8.4 9.8.5

Loudspeaker ... 116 Fan ... 117 Power inlet module ... 118 Power supply “XP” ... 120 VDC, Video connector board ... 121

10

Technical specifications ... 123

10.1 10.2

Ambient conditions ... 123 Dimensions/ Weight ... 123

10.3

Ratings ... 123

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1 Preface

1 Preface This service manual is intended for use by ACUTRONIC Medical Systems AG trained and authorized service personnel. ACUTRONIC Medical Systems AG does not condone or approve of service activity on its products by other than ACUTRONIC Medical Systems AG trained or authorized personnel and ACUTRONIC Medical Systems AG is not responsible for any unauthorized repairs or modifications, or any repairs or modifications made by unauthorized procedures. Use of the incorrect part, or failure to exercise due care in the installation, removal, servicing, checkout or calibration of parts and equipment or the use of unauthorized accessories, may result in damage to the equipment which may in turn result in damage in property and injury (including death) to persons. The purchaser and installer of these parts shall bear full responsibility and liability for the above. All maintenance performed within the applicable warranty period must be authorized in advance by an ACUTRONIC Medical Systems AG service representative in order to retain the warranty status of the subject unit.

1.1 Document Structure Please carefully read the Service manual before using or servicing the ventilator. The table of contents will assist you in quickly locating the respective topic.

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fabian HFO | SM-Rev. 2.10 Ref: 113010.03EN / Date: 24.04.2019

1 Preface

1.2 List of abbreviations Abbreviations which are not generally known, but are used in this manual, are listed below. nCPAP DIO ESD GUI HFO HL7 IfU IVOI O2 P PCB PDMS PIF RS232 SpO2

non-invasive Continuous Positive Airway Pressure Digital Input Output Interface Module Electrostatic Discharge Graphical User Interface High-frequency oscillation Health Level 7 Instruction for Use Protocol from Philips for Intellibridge/Vuelink Oxygen Pressure Printed Circuit Board Patient Data Management System Parallel interface Serial communication transmission of data Peripheral Oxygen Saturation

1.3 Service manual revision history Version

Change

1.00

•

First edition

• • • • •

Complete revision Chapter varying Content modification Battery calibration added Chapter numbering adapted

2.00 2.10

fabian HFO | SM-Rev. 2.10 Ref: 113010.03EN / Date: 24.04.2019

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2 Hardware and Software information

2 Hardware and Software information 2.1 Serial number description Example 1: Example 2:

AI18AA-0001 AI-00832

A: T:

only for internal use Model

10:

HW Revision

AA:

Date of manufacture

0001:

Sequential number

(Before 1st of January 2016) (From 1st of January 2016) N – fabian + nCPAP evolution T – fabian Therapy evolution H – fabian HFO classic I – fabian HFO K – fabian HFO light L – fabian HFO without HFO Module 10 – 1.0 A – January B – February etc.

A – 2012 B – 2013 etc.

From 1st of January 2016 the serial number have been changed to AI, for the device and xxxxx is a sequential number: AI-xxxxx

2.2 Hardware and Software version on Service Sticker You can recognize the hardware and software versions of the components on the Service Sticker (Service Sticker have to be on the EMC shield above the Mainboard.) In any cases if you exchange a component (HW or SW) in the fabian you have to fill out the next column in the Service Sticker. Insofar there was not any modification in the machine you find the factory hardware and software components list in the first column of the Service Sticker

1. Service Sticker (Any modification in the machine is not occurred) 8 / 123

fabian HFO | SM-Rev. 2.10 Ref: 113010.03EN / Date: 24.04.2019

2 Hardware and Software information Always check the version of a PCB in the sticker (Rev.: XX, next to the QR code) on the PCB directly. For example see picture 2:

2. Sticker on the Mainboard shows the HW version is 4.1

2.3 Hardware Revision History Serial no.

Rev.

Change

-

≤AI10DD-00014

1.0

• Prototype

-

≥ AI10ED-00015

1.0

-

≥ AI-00098

-

≥ AI-00101

• New mainboard Rev. 3.2

-

≥ AI-00215

• New mainboard Rev. 3.3

-

≥ AI-00224

• New Accu-PCB Rev. 2.3

-

≥ AI-00401

• New power supply (backward compatible) • New back panel • New blue Inspiration port

-

≥ AI-00590

• New front housing (backward compatible)

-

≥ AI-00702

• New Membrane holder transparent

-

≥ AI-00800

• New mainboard Rev. 4.1 • (only compatible with SW version ≥ 5.0.8)

fabian HFO | SM-Rev. 2.10 Ref: 113010.03EN / Date: 24.04.2019

• • • •

Manifold Rev. 3.1 New HFO-module Type 2 New display (backward compatible) Manifold Rev. 4.1

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3 Important preliminary remarks

3 Important preliminary remarks 3.1 ESD Precautions Always take standard ESD precautions when working on fabian ventilator systems. Ensure the ventilator is disconnected from the AC power supply before performing service or repairs or maintenance.

3.2 Warranty We warranty that this product is free from defects in material and workmanship and, when properly used, will perform in accordance with applicable specifications. If within two years after the original shipment it is found not to meet this standard, it will be repaired at Acutronic Medical Systems AG, or replaced at no charge when returned to an Acutronic Medical Systems AG service facility. Any modification to the equipment, rework or repair by other than Acutronic Medical Systems AG approved personnel will render this warranty null and void. Acutronic Medical Systems AG shall not be liable for any indirect, special or consequential damages, even if notice has been given of the possibility of such damages. THIS WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. The policy of ACUTRONIC Medical Systems AG is to maintain product repair capability for a period of five years after the official sales stop. The two years warranty can only be guaranteed when the yearly maintenance with the preventive maintenance kit was done. All maintenance performed within the applicable warranty period must be authorized in advance by an ACUTRONIC Medical Systems AG service representative in order to retain the warranty status of the subject unit.

3.3 Liability for functionality/ damages The liability for proper function of the apparatus is irrevocably transferred to the owner or operator to the extent the apparatus has been serviced or repaired by personnel not employed or authorised by ACUTRONIC Medical Systems AG Service or when the apparatus was used in a manner not conforming to its intended use. ACUTRONIC Medical Systems AG cannot be held responsible for damage caused by non-compliance with the above-mentioned recommendations. The warranty and liability provisions of the terms of sale and delivery of ACUTRONIC Medical Systems AG are likewise not modified by the recommendations mentioned above.

Description of: Service: Repair: Maintenance:

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measures to maintain desired condition to restore desired condition inspection, service and if applicable, repair

fabian HFO | SM-Rev. 2.10 Ref: 113010.03EN / Date: 24.04.2019

3 Important preliminary remarks

3.4 Service, Repair, Maintenance, Calibration & Testing The Device is a ventilator classifies as Class IIb according to the European directive, as such: • Inspection as per manufacturer specifications is required every 12 months • Maintenance must be performed by Acutronic Medical System AG trained experts with access to appropriate test and measuring equipment. We strongly recommend Acutronic Medical System AG exclusive representatives for service agreements and repairs. Use only original Acutronic Medical System AG parts for repair. Always clean and disinfect equipment or equipment components prior to any maintenance – including when returning the equipment for repair.

Every 12 months Perform the following work: • Maintenance and safety inspections according to the following documents: o TS-AA-17e, Calibration and Test instruction, See Software Release Package, website o TS-FB-27e, Test protocol for service & maintenance, See Software Release Package, website • Preventive Maintenance kit for the device, see “Spare Part Price List” on the website.

Every 4 years Perform the following work: • Maintenance and safety inspections according to the following documents: o TS-AA-17e, Calibration and Test instruction, See Software Release Package, website o TS-FB-27e, Test protocol for service & maintenance, See Software Release Package, website • Preventive Maintenance kit for the device, see “Spare Part Price List” on the website.

Maintenance and the safety check may only be carried out by specialists trained by Acutronic Medical System AG , who have suitable measuring equipment and test facilities. Original packaging should be kept for the possible return of the unit. Only original packaging ensures optimal protection of the equipment during transport. If it is necessary to return the equipment during the warranty period, the manufacturer is not liable for damages caused by incorrect packaging. Original packaging should be kept for the possible return of the unit. Only original packaging ensures optimal protection of the equipment during transport. If it is necessary to return the equipment during the warranty period, the manufacturer is not liable for damages caused by incorrect packaging.

3.5 Contact Phone:

+41 44 729 70 80 +41 44 729 70 86

E-mail:

[email protected]

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4 System overview

4 System overview

3. Acutronic fabian HFO medical ventilator

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fabian HFO | SM-Rev. 2.10 Ref: 113010.03EN / Date: 24.04.2019

4 System overview

4.1 Manifold user side

4. Connectors on the user side of the fabian (without and with silicon caps)

1

Inspiratory tube port/ HFO port

2

Expiratory tube port

3

Proximal pressure measuring tube port

4

External bias flow port and port for nCPAP system based on flow generators (single limb systems)

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4 System overview

4.2 Rear panel

5. Connectors on the back side of the fabian

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1

Connector for 24V DC external power supply (no battery charging!)

2

Network jack for data management, PDMS

3

USB port for data output, Software update and SpO2 Module (MASIMO)

4

RS232 port for PDMS

5

Flow sensor connector

6

Nurse call connector

7

Video In, VGA (not yet implemented)

8

Loudspeaker

9

Fan

10

CO2 sensor

11

Option

12

O2 supply connector 2.0 – 6.5 bar / 40 l/min

13

Pressurised air connector 2.0 – 6.5 bar / 40 l/min

14

Power Connector (Fuse 1.25 AT)

15

Pin for potential equalisation fabian HFO | SM-Rev. 2.10 Ref: 113010.03EN / Date: 24.04.2019

4 System overview For adapting to the DISS system you need: AIR adapter NIST-f to DISS-m / 90 degrees O2 adapter NIST-f to DISS-m / 90 degrees

Warning: Do not connect Ethernet, Nurse call, USB, R232, Flow Sensor ports to anything other than specified devices.

4.2.1 External alarm connector (Nurse call) Plug: Manufacturer: Binder Series 712, 3 pins PIN 2/1

Normal open (NO)

2/3

Normal Closed (NC)

4.2.2 Connector for 12 - 24 VDC The fabian evolution can likewise be operated with an external power supply. An external supply with a voltage of 12 – 24 volts must be connected to the back of the device in this case. Plug: Manufacturer: Binder Series 680, 4 pins PIN 3/4

12 - 24 V DC

1/2

GND

fabian HFO | SM-Rev. 2.10 Ref: 113010.03EN / Date: 24.04.2019

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4 System overview

4.3 Hardware components 4.3.1 Mainboard

6. Mainboard Marks in picture 6 and 7. 1 2

3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18

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Component name NetDCU connector Lithium Battery cell of the Real Time Clock (Type CR2032) UDP connector Touch screen connector Patient gas supply connector Blender connector Fan connector Loud speaker connector Backlight connector Safety relays LCD display connector Flow sensor connector Nurse call connector O2sensor connector Programmer pin strips Hardware version (HW-Rev) Power PCB connector HFO module connector

Comment

If the fabian does not show the correct time, even after refreshment, please exchange the battery of the Real Time Clock.

Monitor, Alarm-PIC, Conductor e.g.: Rev.: 4.1

fabian HFO | SM-Rev. 2.10 Ref: 113010.03EN / Date: 24.04.2019

4 System overview

7. Hardware version of the Mainboard You can identify the version of the Mainboard with the Service sticker or with the Sticker on the Mainboard directly.

fabian HFO | SM-Rev. 2.10 Ref: 113010.03EN / Date: 24.04.2019

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4 System overview

8. Cables which connected to the Mainboard

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fabian HFO | SM-Rev. 2.10 Ref: 113010.03EN / Date: 24.04.2019

4 System overview No. in pic. 8.

Cable name

1

Touch

2

UDP

3

Keyboard

4

Backlight

5

LCD-Display

6

Patient Gas Supply

7

Blender

8

O2 Sensor

9

CO2

10

Flow sensor

11

Speaker

12

Nurse Call

13

Fan

14

Power supply

15

HF-Module

(Meaning of the colours: Lead the cables through the appropriate gaps on the metal housing!)

fabian HFO | SM-Rev. 2.10 Ref: 113010.03EN / Date: 24.04.2019

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4 System overview

4.3.2 NetDCU The NetDCU PCB can be found on the Mainboard, connected via pin strips. The NetDCU contains an exchangeable SD memory card to store the trends, log files and special font characters. Log and trend files can be exported via USB. The NetDCU uses embedded WinCE operation system, therefore the used USB device has to be WinCE compatible (for example: USB1.1). For more information about the downloading of the log files, trends and device information please see Chapter 5.6. The Device ID of the fabian and licenses are stored in the inner memory of the NetDCU, therefore at replacing the NetDCU module, the fabian will get a new device ID (and a new service-password) and the licenses has to be reinstalled as well (See Licensing submenu and License handling, Chapter 6.8.).

9. NetDCU (SD Card socket is on the upper right) The hardware version of the NetDCU see on the Service Sticker.

10. HW version of the NetDCU

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fabian HFO | SM-Rev. 2.10 Ref: 113010.03EN / Date: 24.04.2019

4 System overview

4.3.3 Power module The device can be operated from an external power source, but features an internal battery (NiMH Powerpack) also. For detailed description on the topic please read the Battery operation Chapter in the IfU. In this document the power module expression means the sum of the following components: - Power PCB - Powerpack NiMH/ Inner battery - Power supply “XP” - Power inlet module The most important components of the Power PCB are shown on the picture below.

11. Power PCB Comp. name on PCB 1 2 3

LED 1 LED 2 LED 3

Function State of charge (See Chapter 5.2) “Power OFF” LED (See Chapter 5.2) Power board in normal condition (See Chapter 5.2) 5V OK (See Chapter 5.2)

4

LED 4

5

12 V OK

(See Chapter 5.2)

Fuse3: Safety OFF function

(See Chapter 5.2)

8

LED 5 F3 (SMD, 3 AT, 125 V” MELF 6125” 6.1mm x 2.7mm) F2 (SMD, 3 AT, 125 V” MELF 6125” 6.1mm x 2.7mm) AKKU

9

J1

ICP2 programmer connector

10

EXT + / EXT -

External power supply connector

11

24V + / 24V -

24V

12

SV1

Mainboard connection

6 7

fabian HFO | SM-Rev. 2.10 Ref: 113010.03EN / Date: 24.04.2019

Fuse2: 24V connection (Power off alarm) (See Chapter 5.2) NiMH Powerpack (Internal battery) connector

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