fabian HFO Service Manual Ver 1.08

fabian HFO Servicemanual

Manufacturer: ACUTRONIC Medical Systems AG Fabrik im Schiffli 8816 Hirzel / Switzerland Phone: +41 44 729 70 80 Fax: +41 44 729 70 81 E-Mail: [email protected] www.acutronic-medical.ch

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fabian HFO Servicemanual

Table of Contents 1

Preface ... 7

2

CMOS Handling Precautions... 8

3

Warranty ... 8

4

Maintenance ... 9

5

Liability for proper function and damage ... 10

6

Revision History ... 11 6.1

Hardware ... 11

6.2

Software / Firmware ... 12

7

Service and maintenance intervals ... 13

8

fabian components ... 14 8.1

Manifold Ports ... 14

8.2

Manifold backside ... 15

8.3 Back Panel ... 16 8.3.1 External alarm connector ( Nurse call )... 17 8.3.2 24 V DC Connector ... 18 8.3.3 Back Panel – component side - ... 19 8.4

Mainboard – overview – Rev. 2.0 ... 20

8.5 Mainboard – overview – Rev. 2.1 ... 21 8.5.1 Mainboard – Watchdog LED - ... 22 8.6

Battery board – overview -... 23

8.7 Proportional gas blender ... 24 8.7.1 Proportional gas blender ( Board Rev. 1.0 ) HW Rev. 1.0... 24 8.7.2 Proportional gas blender ( Board Rev. 1.1 ) HW Rev. 1.0... 25 8.8 HFO Module... 26 8.8.1 Hardware revision ... 26 8.8.2 HFO Board ... 28 8.8.3 HFO pneumatic ... 28 9

Pneumatic diagrams / Drawings ... 29 9.1

Proportional blender ( with HFO module < 2.0 ) ... 29 4 / 86

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fabian HFO Servicemanual 9.2

Proportional blender ( with HFO module ≥ 2.0 ) ... 30

9.3 Proportional blender ( with purge flow ) ... 31 9.3.1 Proportional blender - drawing – ... 32 9.4 Manifold ... 33 9.4.1 Manifold - drawing – ... 34 9.5

HFO module ( HW < 2.0 ) ... 35

9.1 HFO module ( HW ≥ 2.0 ) ... 36 9.1.1 HFO Module – drawing – ... 37 10 Software update Instruction ... 38 10.1

Required tools for SW update ... 39

10.2 HMI update... 40 10.2.1 Software update with USB stick ... 41 10.2.2 Software update, Unit is not booting from USB ... 42 10.3 Software update, procedure ... 43 10.3.1 Update PIC ressources ... 43 10.3.2 Update fabian HFO Resources ( HMI ) ... 44 10.3.3 Loading factory defaults ... 45 10.4 PIC upgrade Blender / Alarm / Battery board ... 46 10.4.1 PIC Connector Mainboard ... 46 10.4.2 PIC Connector Blender ... 47 10.4.3 PIC Connector Battery board ... 48 10.4.4 PIC Processor upgrade with ICD3 programmer... 49 10.4.5 PIC Processor upgrade with Softlog ICP2 programmer ... 52 10.4.6 Update the Softlog programmer ... 53 11 Tools / Repair Info ... 54 11.1

Alarms OFF ... 54

11.2

Required Tools ... 54

11.3

Breathing tube test set... 55

11.4

Holding device ... 56

12 Repair / HW upgrade instruction ... 57 12.1.1 12.1.2 12.1.3 12.1.4

Exchange of fuses ... 57 Replacing Air and O 2 inlet filters ... 58 Replacing Oxygen sensor ... 59 Replacing the exhalation valve membrane ... 60 5 / 86

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fabian HFO Servicemanual 12.2

HFO module upgrade ... 61

12.3

Purge flow upgrade ... 63

13 Calibration... 66 13.1

Calibration - tools ... 66

13.2

Proximal pressure sensor calibration ( without purge flow ) ... 67

13.3

Proximal pressure sensor calibration ( with purge flow ) ... 69

13.4

Inspiration pressure sensor calibration ( pmix ) ... 71

13.5

Calibration Blender ( Rev. 1.1 ) ... 73

13.6

Exhalation Valve Calibration ... 75

13.7 Service Mode Screens ... 77 13.7.1 System ... 77 13.7.2 Calibration ... 77 13.7.3 Blenderboard... 78 13.7.4 Monitor PIC ... 79 13.7.5 Accuboard ... 80 13.7.6 Valves... 80 13.7.7 Display ... 81 13.7.8 Settings ... 81 13.7.9 Interfaces ... 82 13.7.10 Info... 82 13.7.11 Licensing ... 83 14 User Manual Testlung ... 84 15 Complete Device Check ... 86 16 System - check ... 86 17 Spareparts ... 86 18 Technical Specifications ... 86

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fabian HFO Servicemanual

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 a ACUTRONIC Medical Systems AG service representative in order to retain the warranty status of the subject unit. Statements in the operating instructions preceded by words “Warning,” “Caution,” and “Note” carry special significance. The definitions of these words are as follows: WARNING ! Means there is a possibility of injury to oneself or others CAUTION ! Means there is a possibility of damage to the instrument or other property

NOTE !

Indicates points of particular interest for more efficient and convenient operation.

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fabian HFO Servicemanual

2 CMOS Handling Precautions The following precautions must be observed whenever a circuit board or an integrated circuit is handled. Failure to do so may result in serious damage to the fabian. Place fabian and parts on a grounded, conductive work surface Ground yourself (with a strap having about 1 MOhm resistance ) Ground the frame of any test instrument or soldering iron to be used If any circuit boards are to be stored or transported, enclose them in conductive (anti-static) envelopes

3 Warranty We warrant that this product is free from defects in material and workmanship and, when properly used, will perform in accordance with applicable specifications. If within one year after the original shipment it is found not to meet this standard, it will be repaired, at Acutronic Medical Systems AG option, or replaced at no charge when returned to an Acutronic Medical Systems AG service facility. Any modification to the equipment or 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 ten years after the original shipment and to make this capability available at the then prevailing schedule of charge. All maintenance performed within the applicable warranty period must be authorized in advance by a ACUTRONIC Medical Systems AG service representative in order to retain the warranty status of the subject unit

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fabian HFO Servicemanual

4 Maintenance Fabian HFO is a Neonatal and Infant Ventilator and classified as Il b according all applicable th requirements for Medical Products according 93/42 EWG council of European Union dated June 14 , 1993 for Medical Products. 1.) The apparatus must be inspected by experts at regular 12 months interval . 2.) We recommend obtaining a service contract with ACUTRONIC Medical Systems AG exclusive distributor in your country. 3.) Repairs and general overhaul on the apparatus may only be carried out by ACUTRONIC Medical Systems AG Service. 4.) Only original ACUTRONIC Medical Systems AG spare parts may be used for maintenance. 5.) Power connection: The apparatus is to be used only in rooms with mains power supply installations complying with national standards. The standards laid down in IEC-601/1 Safety for Medical Electrical Equipment, are applicable for electrically powered equipment.

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5 Liability for proper function and damage 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. ACUTRONIC Medical Systems AG

Service: Repair: Maintenance:

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

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6 Revision History 6.1 Hardware

Serial no.

Rev.

20-00101-P to

0.9

20-00109-P

Prototype

from 20-00110-S

from 20-00130-S

from

1.0

1.1

1.2

20-00150-S

from

Change •

Prototype

• • •

Mainboard Rev. 2.0 no extra grounding wire New Multiplexer (74HCT4052D)

•

HW upgrade on mainboard for CO2 measurement.

• •

Fan with speed signal 5 volt connection for CO2 measurements directly soldered on printed circuit boards T501 Label with HW Revision below type plate

•

1.3

20-00160-S from 20-00173-S

1.4

from 20-00173-S

1.4 and upgraded equipment

•

Schurter Power Entry module 4301.5202 • Sound absorber ( strainer insert ) integrated in proportional blender • new hose connection between blender and manifold with F400 filter instead of strain insert. To avoid whistling noise from blender. • HFO Module with new “ trapezoidal spring “ SN ≥ HB-A036 • See label below type plate HFO Rev.2.0 • ! HFO feed Inspiratory ! • ! No Bleed flow !

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fabian HFO Servicemanual

Serial no.

Rev.

from

1.4

20-00189-S

and upgraded equipment

from

Change

1.5

20-00208-S

1.6 from 20-00304-S

and upgraded equipment

6.2 Software / Firmware This service manual covers the following SW revision

Firmware Version

Version

NetDCU Kernel

≤ 1.22

HMI Software

≤ 1.2.0.38

Conductor PIC

≤ 3.0.3

Monitor PIC

≤ 2.6.7

Alarm PIC

≤ 2.6

Blender PIC

≤ 2.5

Accu PIC

≤ 4.7

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•

Mainboard Rev. 2.1

• • • • •

New print on rear panel New Air and O2 inlet filter Art.Nr.: 20-01-0088 Cooling air filter in bottom case New rubber feet ( h=15 mm ) Some Improvements in the inner housing

• •

New LCD with LED backlight Purge flow in Proximal line

fabian HFO Servicemanual

7 Service and maintenance intervals Always clean and disinfect equipment or equipment components prior to any maintenance – including when returning the equipment for repair.

Every 6 month Perform the following work:  Clean cooling air filter (casing bottom), replace if necessary

Every 12 month Maintenance and safety inspections Perform the following work:  Check alarm and limit value functions  Check pressure connections  Check electrical connections  Check safety shutdown calibration Replace the following components:  Air and oxygen inlet filter ( 2 pieces Part no.: 3697 ) from SN 20-00208-S , 2 pieces Part no.: 7714  Cooling air filter (casing bottom) ( 2 pieces Part no.: 20-01-0059 )  O2 sensor ( Part no. 7003 )

Every 4 years Replace the following components:  Proportional valves air and oxygen ( 2 pieces Part no.: 20-01-0018 )  Input pressure regulator pressurised air / oxygen ( Part no.: 20-03-0017 )  2 pcs. calibration valve ( Part no.: 20-01-0023 )  Lithium battery CR2032 ( Part no.: 20-01-0060 )  Complete HFO module ( in exchange )

Maintenance and safety inspections must be performed by Acutronic trained experts with access to suitable testing and measuring equipment.

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8 fabian components 8.1 Manifold Ports

1 2

Inspiratory tube port. Centre port for connecting the nCPAP system Expiratory tube port.

3

Pressure measuring tube port Prox

4

HFO port

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8.2 Manifold backside

1 2

Inspiratory tube port. Inspiratory pressure port

3

to proximal port

4

Pneumatic pressure relief valve ( approx. 90 mbar )

5

Safety valve coil

6

Exhalation valve coil

7

HFO port

8

Calibration poti ( pmix 60 mbar )

9

Calibration Poti ( pmix 0 mbar )

10

Pressure sensor ( inspiratory )

11

Pressure sensor ( proximal )

12

Pressure sensor board

13

Connector to Mainboard

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8.3 Back Panel

1 2

Connector for 24V DC external power supply (no charging!) Network jack for data management , PDMS

3

USB port for data output and update

4

RS232 port for CO 2 Option OR PDMS

5

Flow sensor connector

6

Nurse call connector

7

Loudspeaker

8

Fan

9

Optional ports

10

Power Connector

11

Pin for potential equalisation

12

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

13

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fabian HFO Servicemanual 8.3.1 External alarm connector ( Nurse call )

PIN 1-2

Normal open ( NO )

1-3

Normal closed ( NC )

External alarm plug

Art. Nr. 99-0405-00-03 ( manufacturer ) Other versions available

Typ Series 712 ( 3 pin )

Manufacturer Binder ( www.binder-connector.de )

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fabian HFO Servicemanual 8.3.2 24 V DC Connector

PIN 1

+ 24 V DC ( plus )

2

GND

24 V DC Plug

Art. Nr. 09-0302-00-02 ( manufacturer )

Typ Series 680 ( 2 pin )

Manufacturer Binder ( www.binder-connector.de )

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fabian HFO Servicemanual 8.3.3 Back Panel – component side -

Please see also Sparepartslist fabian HFO for details

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fabian HFO Servicemanual

8.4 Mainboard – overview – Rev. 2.0

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8.5 Mainboard – overview – Rev. 2.1 Changes since revision 2.0: -

5V for RS232 now internal wired Fuse 1 AT mounted directly on Mainboard Improved “ clean sensor alarm “ detection in HFO mode

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