Vers. 1.09 Rev. 1.17 Service Manual fabian HFO fabian HFO Servicemanual Servicemanual Revision History Version Change 1.02 first edition 1.03 Revision History change in blender pneumatic diagram description Nurse call connector 1.04 Pneumatic Pressure relief Valve ( nCPAP, approx. . 400 mbar ) Revision History Software update instructions 1.05 Pneumatic diagram for HFO module 2.0 and blender revised chapter 9.5 / 9.7 / 10 1.06 SW upgrade – Processor type revised ( Chapt. 11 ) Processor upgrade with Softlog programmer important information regarding spring type in HFO module ( Chapter 9.8 ) Screenshot updated ( Chapter 13.5 ) New Chapter 13.5.11 Licensing Revision History , revised 1.07 24 VDC Plug is Series 680 NOT Series 830 New picture Back panel Manual complete revised 1.08 HW revision list revised Chapter “pneumatic diagram” , revised Chapter “ calibration “ revised Chapter “ repair / HW upgrade , revised and new 1.09 Chapter - 13 Calibration removed. Test and calibration now in own document 6.1 Serial number description 7.1 Information maintenance internal battery 12.1.5. Replace battery pack 2 / 84 SM fabian-HFO- 1.17.docx fabian HFO Servicemanual 1.10 Service interval: Change HFO Membrane not complete HFO module 8.3 Manifold V2 8.5 Rear panel V2 8.6 Info netDCU 8.10 Power board rev. 2.1 8.12 Blender V2 8.13 Info proportional valve 8.14p Internal tubing 9.7 Manifold V2 pneumatic 9.7.2 Manifold V2 drawing 10.3 revised 10.3.4 revised 1.11 PIC programming with PICkit 3 1.12 Update “ registry “ and “ copy files “ implemented Chapter 8.5.2 New 24 VDC connector 1.13 Chapter 10.2 file structure update stick New Chapter 10.4 SW update with netDCU 1.14 Battery board now called “ power board “ Chapter 10.5 renamed in: Processor port connections Delete chapter 10.5.4 - 10-5.7 PIC Processor upgrade See new Document: “Processor update instruction” 1.15 Chapter 8.15.4 colour coded tubing 10.2 removed. See new document: fabian update instruction 10.3.4 Removed. See new Document: Processor update instruction 12.2 NEW chapter. Error codes 1.16 Chapter 12.2 revised 1.17 New chapter 10.3 3 / 84 SM fabian-HFO- 1.17.docx 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: info@acutronic-medical.ch www.acutronic-medical.ch 4 / 84 SM fabian-HFO- 1.17.docx fabian HFO Servicemanual Table of Contents 1) Preface................................................................................................................. 8 2) CMOS Handling Precautions ............................................................................... 9 3) Warranty .............................................................................................................. 9 4) Maintenance ...................................................................................................... 10 5) Liability for proper function and damage ............................................................ 11 6) Revision History ................................................................................................. 12 6.1 Serialnumber description : ........................................................................... 12 6.2 Hardware Revision History .......................................................................... 12 6.3 Software / Firmware .................................................................................... 13 7) Service and maintenance intervals .................................................................... 14 7.1 Maintenance internal battery ....................................................................... 15 8) fabian components ............................................................................................. 16 8.1 Manifold Ports ............................................................................................. 16 8.2 Manifold rear side ( V1 ) .............................................................................. 17 8.3 Manifold rear side ( V2 ) .............................................................................. 18 8.4 Rear Panel V1 ............................................................................................. 19 8.5 Rear Panel V2 ............................................................................................. 20 8.5.1 Nurse call connector ............................................................................. 21 8.5.2 24 V DC Connector ............................................................................... 22 8.5.3 Rear Panel – component side -............................................................. 23 8.6 Mainboard – overview – Rev. 2.0 ................................................................ 24 8.7 Mainboard – overview – Rev. 2.1 ................................................................ 25 8.8 Mainboard – overview – Rev. 3.0 ................................................................ 26 8.8.1 Mainboard – Watchdog LED - ............................................................... 27 8.9 Power board – overview –Rev. 1.0 .............................................................. 28 8.10 Power board – overview –Rev. 2.1 / 2.1.1 ................................................... 29 8.11 Proportional gas blender V1 ........................................................................ 30 8.11.1 Proportional gas blender ( Board Rev. 1.0 ) HW Rev. 1.0 ................. 30 8.11.2 Proportional gas blender ( Board Rev. 1.1 ) HW Rev. 1.0 ................. 31 8.12 Proportional gas blender V2 ........................................................................ 32 8.13 Proportional valve ........................................................................................ 33 8.14 Internal tubing .............................................................................................. 34 8.14.1 Internal tubing fabian HFO with blender V1 and manifold V1 ............ 34 8.14.2 Internal tubing fabian HFO with blender V1 and manifold V2 ............ 35 8.14.3 Internal tubing fabian HFO with blender V2 and manifold V1 ............ 36 5 / 84 SM fabian-HFO- 1.17.docx fabian HFO Servicemanual 8.14.4 8.14.5 Internal tubing fabian HFO with blender V2 and manifold V2 ............ 37 Colour coded tubing........................................................................... 38 8.15 HFO Module ................................................................................................ 39 8.15.1 Hardware revision .............................................................................. 39 8.15.2 HFO Board ........................................................................................ 41 8.15.3 HFO pneumatic ................................................................................. 41 9) Pneumatic diagrams / Drawings ........................................................................ 42 9.1 Proportional blender V1 ( with HFO module < 2.0 ) ..................................... 42 9.2 Proportional blender V1 (with HFO module ≥ 2.0 ) ...................................... 43 9.3 Proportional blender V1 (with purge flow ) ................................................... 44 9.4 Proportional blender V2 connected to manifold V1 ..................................... 45 9.5 Proportional blender V2 connected to manifold V2 ..................................... 46 9.5.1 Proportional blender V1 - drawing –..................................................... 47 9.5.2 Proportional blender V2 – drawing ........................................................ 47 9.6 Manifold V1 pneumatic diagram .................................................................. 48 9.7 Manifold V2 pneumatic diagram .................................................................. 49 9.7.1 Manifold V1 drawing ........................................................................... 50 9.7.2 Manifold V2 drawing ............................................................................. 51 9.8 HFO module ( HW < 2.0 ) ............................................................................ 52 9.9 HFO module ( HW ≥ 2.0 ) ............................................................................ 53 9.9.1 HFO Module – drawing – ...................................................................... 54 10) Software update ................................................................................................. 55 10.1 Required tools for SW update ..................................................................... 56 10.2 Software update .......................................................................................... 57 10.3 Configure USB update ( AcuInstall.ini ) ....................................................... 57 10.4 Processor port connections ......................................................................... 58 10.4.1 PIC Connector Mainboard ................................................................. 58 10.4.2 PIC Connector Blender ...................................................................... 59 10.4.3 PIC Connector Power board .............................................................. 60 10.4.4 PIC Processor upgrade ..................................................................... 61 11) Tools / Repair Info .............................................................................................. 62 11.1 Alarms OFF ................................................................................................. 62 11.2 Required Tools ............................................................................................ 62 11.3 Holding device ............................................................................................. 63 12) Repair / HW upgrade instruction ........................................................................ 64 12.1.1 12.1.2 12.1.3 12.1.4 Exchange of fuses ............................................................................. 64 Replacing Air and O2 inlet filters ........................................................ 65 Replacing Oxygen sensor.................................................................. 66 Replacing the exhalation valve membrane ........................................ 67 6 / 84 SM fabian-HFO- 1.17.docx fabian HFO Servicemanual 12.1.5 Replacing battery pack ...................................................................... 68 12.2 Error codes .................................................................................................. 69 12.2.1 Blender codes .................................................................................... 69 12.2.2 Watchdog / Software ......................................................................... 70 12.2.3 Hardware ........................................................................................... 70 12.3 HFO module upgrade .................................................................................. 71 12.4 Purge flow upgrade ..................................................................................... 73 13) Calibration .......................................................................................................... 76 13.1 Calibration - tools......................................................................................... 76 14) Service Mode Screens ....................................................................................... 77 14.1 System ........................................................................................................ 77 14.1.1 Calibration ......................................................................................... 77 14.1.2 Blenderboard ..................................................................................... 78 14.1.3 Monitor PIC ........................................................................................ 79 14.1.4 Accuboard ......................................................................................... 80 14.1.5 Valves ................................................................................................ 80 14.1.6 Display ............................................................................................... 81 14.1.7 Settings.............................................................................................. 81 14.1.8 Interfaces ........................................................................................... 82 14.1.9 Info..................................................................................................... 82 14.1.10 Licensing ........................................................................................... 83 15) AcuLink / PDMS / Network connection .......................................................... 84 16) Complete Device Check..................................................................................... 84 17) System - check .................................................................................................. 84 18) Spare parts ........................................................................................................ 84 19) Technical Specifications..................................................................................... 84 7 / 84 SM fabian-HFO- 1.17.docx 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. 8 / 84 SM fabian-HFO- 1.17.docx 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 9 / 84 SM fabian-HFO- 1.17.docx fabian HFO Servicemanual 4) Maintenance Fabian HFO is a Neonatal and Infant Ventilator and classified as Il b according all applicable requirements for Medical Products according 93/42 EWG council of European Union dated June 14th, 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. 10 / 84 SM fabian-HFO- 1.17.docx fabian HFO Servicemanual 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 11 / 84 SM fabian-HFO- 1.17.docx fabian HFO Servicemanual 6) Revision History 6.1 Serialnumber description : Example : AN10AA-0001 ( new SN from HW Rev. 1.7 ) A: N: only for internal use Model 10 HW Revision AA Date of manufacture 0001 Sequential number 6.2 N – fabian +nCPAP evolution T – fabian therapy evolution H – fabian HFO K – fabian HFO without HFO Module 10 – 1.0 11 – 1.1 etc. A – January A - 2012 B – February etc. B – 2013 etc. Hardware Revision History Serial no. Rev. 20-00101-P to 0.9 20-00109-P Prototype from 20-00110-S from 20-00130-S from Change 1.0 1.1 1.2 20-00150-S from 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 12 / 84 SM fabian-HFO- 1.17.docx 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 now Inspiratory ! ! No Bleed flow ! fabian HFO Servicemanual from 1.4 20-00189-S and upgraded equipment from 1.5 20-00208-S from 20-00304-S – 20-00354-S 1.6 and upgraded equipment from AH17HA-00355 1.7 From xx18xx-00450 1.8 6.3 Mainboard Rev. 2.1 New print on rear panel New Air and O2 inlet filter Part..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 New Serial numbers Mainboard and Power board “Retrofitting” Manifold cover New Mainboard Rev. 3.0 New Power Board Rev. 2.1 New internal housing New Rear panel New Power supply New Side panel Software / Firmware This service manual covers the following SW revision Firmware Version Version NetDCU Kernel 1.27 HMI Software ≥ 3.0.0 Conductor / Controller PIC ≥ 3.3.16 Monitor PIC ≥ 3.9.15 Alarm PIC ≥ 3.02 Blender PIC ≥ 5.2 Accu PIC ( HW Rev. 1.0 ) ≥ 5.1 Accu PIC ( HW Rev. 2.1 ) ≥ 5.3 13 / 84 SM fabian-HFO- 1.17.docx 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 months Perform the following work: Filter (casing bottom), replace if necessary Every 12 months 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 Input filter Filter (casing bottom) O2 sensor Every 4 years Replace the following components: Air and oxygen Input filter Filter (casing bottom) O2 sensor Proportional valves. pressurised air / oxygen mixer ( Type MiM or FAS ) Input pressure regulator pressurised air / oxygen 2 pcs. calibration valve Lithium battery CR2032 HFO Membrane Maintenance and safety inspections must be performed by Acutronic trained experts with access to suitable testing and measuring equipment. 14 / 84 SM fabian-HFO- 1.17.docx fabian HFO Servicemanual 7.1 Maintenance internal battery The internal battery is maintenance free ! Under normal use the battery has no wear and tear. Due to the high quality of the battery and environmental reasons a regular battery replacement is not required. Check the capacity of the battery annually A full charged battery must have a operating time of 2 hours. Mode: IPPV, pediatrics standard settings, gas supply connected 15 / 84 SM fabian-HFO- 1.17.docx fabian HFO Servicemanual 8) fabian components 8.1 Manifold Ports 1 Inspiratory tube port. Centre port for connecting the nCPAP system and O2 Therapy 2 Expiratory tube port. 3 Pressure measuring tube port proximal 4 HFO port 16 / 84 SM fabian-HFO- 1.17.docx fabian HFO Servicemanual 8.2 Manifold rear side ( V1 ) Figure without purge flow connection. See chapter 8.14 internal tubing for more details. 1 Inspiratory tube port. 2 Inspiratory pressure port 3 Proximal pressure port 4 Pneumatic pressure relief valve ( 120 + 5 mbar ) 5 Safety valve coil ( opens 10 mbar above set pmax ) 6 Exhalation valve coil 7 HFO port 8 Calibration pot ( p insp 60 mbar ) 9 Calibration pot ( p insp 0 mbar ) 10 Pressure sensor ( p insp ) 11 Pressure sensor ( p prox ) 12 Pressure sensor board 13 Connector to Mainboard 17 / 84 SM fabian-HFO- 1.17.docx fabian HFO Servicemanual 8.3 Manifold rear side ( V2 ) 1 Inspiratory tube port. 2 Inspiratory pressure port 3 Purge flow inlet from blender 4 Proximal pressure port 5 Safety valve coil ( opens 10 mbar above pmax ) 6 Exhalation valve coil 7 HFO port 8 Calibration pot ( pinsp. 60 mbar ) 9 Calibration Pot ( pinsp 0 mbar ) 10 Pressure sensor ( p insp ) 11 Pressure sensor ( p prox ) 12 Pressure sensor board 13 Connector to Mainboard 1 Pneumatic pressure relief valve (. 120 + 5 mbar ) 18 / 84 SM fabian-HFO- 1.17.docx fabian HFO Servicemanual 8.4 Rear Panel V1 1 Connector for 24V DC external power supply (no charging!) 2 Network jack for data management , PDMS 3 USB port for data output and update 4 RS232 port for CO2 Option OR PDMS 5 Flow sensor connector 6 Nurse call connector 7 Loudspeaker 8 Fan 9 Optional ports 10 Power Connector ( fuse 1 AT ) 11 Pin for potential equalisation 12 O2 supply connector 2.0 – 6.5 bar / 40 l/min 13 Pressurised air connector 2.0 – 6.5 bar / 40 l/min 19 / 84 SM fabian-HFO- 1.17.docx fabian HFO Servicemanual 8.5 Rear Panel V2 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 4 RS232 port for PDMS 5 Flow sensor connector 6 Nurse call connector 7 Video In , VGA ( option ) 8 Loudspeaker 9 Fan 10 CO2 sensor ( option ) 11 Nebulizer, ultrasonic ( 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 20 / 84 SM fabian-HFO- 1.17.docx fabian HFO Servicemanual 8.5.1 Nurse call connector PIN 1-2 Normal open ( NO ) 1-3 Normal closed ( NC ) Nurse call plug Art. Nr. 99-0405-00-03 (manufacturer no. ) Typ Series 712 ( 3 pin ) Manufacturer Binder ( www.binder-connector.de ) 21 / 84 SM fabian-HFO- 1.17.docx fabian HFO Servicemanual 8.5.2 24 V DC Connector Rear panel V1 Plug: Manufacturer: Binder Series 680, 2 pin PIN 1 GND 2 + 24 V DC View on soldering side Rear panel V2 Plug: Manufacturer: Binder Series 680, 4 pin PIN 1/2 GND 3/4 + 24 V DC View on soldering side ( Plug ) 22 / 84 SM fabian-HFO- 1.17.docx fabian HFO Servicemanual 8.5.3 Rear Panel – component side - Power Supply: fabian HFO Rear panel V1 fabian HFO Rear panel V2( HW Rev. from 1.8 ): XP Power RCL175PS24C FRIWO OF 150-24 Please see also Spare part list fabian HFO for details 23 / 84 SM fabian-HFO- 1.17.docx fabian HFO Servicemanual 8.6 Mainboard – overview – Rev. 2.0 24 / 84 SM fabian-HFO- 1.17.docx fabian HFO Servicemanual 8.7 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 25 / 84 SM fabian-HFO- 1.17.docx fabian HFO Servicemanual 8.8 Mainboard – overview – Rev. 3.0 26 / 84 SM fabian-HFO- 1.17.docx fabian HFO Servicemanual 8.8.1 Mainboard – Watchdog LED A watchdog circuit monitors the processors of the device. The led lights when the processor is ok. D600 Monitor PIC D601 Controller PIC D602 NetDCU D603 Alarm PIC 27 / 84 SM fabian-HFO- 1.17.docx fabian HFO Servicemanual 8.9 Power board – overview –Rev. 1.0 Power board 1.0 is compatible to Mainboard 2.x and 3.x LED 1 “Power OFF” LED LED 2 State of charge OFF Flashes ( quickly ) Flashes ( 1 / sec ) Flashes ( 1 / min ) Unit in Battery mode Battery failure / Battery disconnected Charging Battery full / Unit in mains operation LED 3 ON 5V OK LED 4 ON 12 V OK LED 5 Flashes Power board in normal condition F1 24V connection ( 10 AT FF ) F2 Main fuse ( 10 A FF ) F3 Safety OFF function ( 3 A T ) 28 / 84 SM fabian-HFO- 1.17.docx fabian HFO Servicemanual 8.10 Power board – overview –Rev. 2.1 / 2.1.1 Power board 2.1 / 2.1.1 is compatible to Mainboard 2.x and 3.x LED 1 State of charge OFF Flashes ( quickly ) Flashes ( 1 / sec ) Flashes ( 1 / min ) Unit in Battery mode Battery failure / Battery disconnected Charging Battery full / Unit in mains operation LED 2 “Power OFF” LED LED 3 Flashes Power board in normal condition LED 4 ON 5 Volt OK LED 5 ON 12 Volt OK F1 Fuse 24V connection ( 10 A FF ) F2 Main fuse ( 10 A FF ) F3 Fuse Safety OFF function ( 3 A T ) 29 / 84 SM fabian-HFO- 1.17.docx fabian HFO Servicemanual 8.11 Proportional gas blender V1 8.11.1 Proportional gas blender ( Board Rev. 1.0 ) HW Rev. 1.0 The connections of Proportional valves may mounted ( soldered ) directly on the board. ( only the first Blender with Rev. 1.0 ) 1 Pressure regulator O2 2 Pressure regulator Air 3 Gas inlet O2 4 Gas inlet Air 5 Calibration valve O2 ( Oxygen sensor ) 6 Calibration valve Air ( Oxygen sensor ) 7 Pressure sensor O2 8 Pressure sensor Air 9 Proportional valve O2 ( FAS ) 10 Proportional valve Air ( FAS ) 11 Bleed Air to HFO Module ( only HFO module < 2.0 ) 12 O2 sensor compartment with O2 sensor 13 Bleed gas outlet 14 O2 measurement inlet 15 Patient gas 16 Pneumatic Pressure relief Valve ( nCPAP, 500 ± 100 mbar ) 17 Processor port 30 / 84 SM fabian-HFO- 1.17.docx fabian HFO Servicemanual 8.11.2 Proportional gas blender ( Board Rev. 1.1 ) HW Rev. 1.0 Changes since revision 1.0: - new position of the processor port new calibration pots for flow 1 Calibration pot, flow 2 Processor port 31 / 84 SM fabian-HFO- 1.17.docx fabian HFO Servicemanual 8.12 Proportional gas blender V2 With Purge flow connector. 1 Pressure regulator O2 15 Purge flow connector to manifold 2 Pressure regulator Air 16 Pneumatic Pressure relief Valve ( nCPAP, 500 ± 100 mbar ) 3 Gas inlet O2 17 Flow sensor 4 Gas inlet Air 18 Calibration pot Air valve 5 Calibration valve O2 19 Calibration poi Oxygen valve 6 Calibration valve Air 20 Connector to ,mainboard 7 Pressure sensor O2 21 Processor port 8 Pressure sensor Air 9 Proportional valve O2 ( MIM ) 10 Proportional valve Air ( MIM ) 11 O2 sensor compartment 12 Bleed gas outlet 13 O2 measurement inlet 14 Patient gas 32 / 84 SM fabian-HFO- 1.17.docx fabian HFO Servicemanual 8.13 Proportional valve TYPE : FAS Installed in blender V1 Type : MiM Installed in blender V2 Both valves have the same function and are compatible to the blender PCB 1.1 To change the FAS with a MIM Valve you must change the mounting block ! To use the MiM proportional valve the installed FW on the blender board must be ≥ 3.2 33 / 84 SM fabian-HFO- 1.17.docx fabian HFO Servicemanual 8.14 Internal tubing 8.14.1 Internal tubing fabian HFO with blender V1 and manifold V1 34 / 84 SM fabian-HFO- 1.17.docx fabian HFO Servicemanual 8.14.2 Internal tubing fabian HFO with blender V1 and manifold V2 35 / 84 SM fabian-HFO- 1.17.docx fabian HFO Servicemanual 8.14.3 Internal tubing fabian HFO with blender V2 and manifold V1 36 / 84 SM fabian-HFO- 1.17.docx fabian HFO Servicemanual 8.14.4 Internal tubing fabian HFO with blender V2 and manifold V2 Nozzle for purge flow is integrated in the manifold 37 / 84 SM fabian-HFO- 1.17.docx fabian HFO Servicemanual 8.14.5 Colour coded tubing Colour coded from Serial number: 00738 RED: BLUE: YELLOW: GREEN: mixed gas to patient purge flow (only fabian +nCPAP ) proximal pressure sensor Pinsp. Pressure sensor 38 / 84 SM fabian-HFO- 1.17.docx fabian HFO Servicemanual 8.15 HFO Module 8.15.1 Hardware revision Revision < 2.0 Amplitude max 60 mbar Cylindrical spring Air bleed HFO connected to expiratory port Spring type must set to cylindrical! Otherwise the HFO module will be demaged. 39 / 84 SM fabian-HFO- 1.17.docx fabian HFO Servicemanual Revision ≥ 2.0 Amplitude max 80 mbar Trapeziodal spring ( conical ) NO Air bleed HFO connected to inspiratory port Spring type must set to conical! Otherwise the HFO module working with Amplitude not higher than 60 mbar. 40 / 84 SM fabian-HFO- 1.17.docx fabian HFO Servicemanual 8.15.2 HFO Board 1 Connector mainboard 2 Processor port 3 Connector HFO Valve / Air bleed ( only HFO module Rev. < 2.0 ) 8.15.3 HFO pneumatic Vers. < 2.0 Vers. 2.0 1 HFO Valve ( open / close ) 2 HFO outlet port 3 Valve and connector , HFO Air bleed ( only HFO module Rev. < 2.0 ) 41 / 84 SM fabian-HFO- 1.17.docx fabian HFO Servicemanual 9) Pneumatic diagrams / Drawings 9.1 Proportional blender V1 ( with HFO module < 2.0 ) 42 / 84 SM fabian-HFO- 1.17.docx fabian HFO Servicemanual 9.2 Proportional blender V1 (with HFO module ≥ 2.0 ) 43 / 84 SM fabian-HFO- 1.17.docx fabian HFO Servicemanual 9.3 Proportional blender V1 (with purge flow ) 44 / 84 SM fabian-HFO- 1.17.docx fabian HFO Servicemanual 9.4 Proportional blender V2 connected to manifold V1 45 / 84 SM fabian-HFO- 1.17.docx fabian HFO Servicemanual 9.5 Proportional blender V2 connected to manifold V2 46 / 84 SM fabian-HFO- 1.17.docx fabian HFO Servicemanual 9.5.1 Proportional blender V1 - drawing – 9.5.2 Proportional blender V2 – drawing 47 / 84 SM fabian-HFO- 1.17.docx fabian HFO Servicemanual 9.6 Manifold V1 pneumatic diagram 48 / 84 SM fabian-HFO- 1.17.docx fabian HFO Servicemanual 9.7 Manifold V2 pneumatic diagram 49 / 84 SM fabian-HFO- 1.17.docx fabian HFO Servicemanual 9.7.1 Manifold V1 drawing 50 / 84 SM fabian-HFO- 1.17.docx fabian HFO Servicemanual 9.7.2 Manifold V2 drawing - Integrated purge flow nozzle Pneumatic pressure relief valve on bottom side 16 51 / 84 SM fabian-HFO- 1.17.docx fabian HFO Servicemanual 9.8 HFO module ( HW < 2.0 ) 52 / 84 SM fabian-HFO- 1.17.docx fabian HFO Servicemanual 9.9 HFO module ( HW ≥ 2.0 ) 53 / 84 SM fabian-HFO- 1.17.docx fabian HFO Servicemanual 9.9.1 HFO Module – drawing – 54 / 84 SM fabian-HFO- 1.17.docx fabian HFO Servicemanual 10) Software update A Software “update” can also be an “upgrade “ with new features. The fabian HFO Ventilator uses a basic pneumatic structure that is controlled by two PIC micro controllers on the main board. A single board computer (CPU) on the main board provides the user interface and supervises the pneumatic controllers. The ventilator can be used in different operating (ventilation) modes that are completely software controlled. The control of the fabian HFO essentially consists of following component located Update via Processor User Interface Mainboard NetDCU USB RISC Controller PIC Conductor PIC Mainboard USB or ICSP PIC18F2520 Monitor PIC Mainboard USB dsPIC33FJ128GP706 Alarm PIC Mainboard ICSP PIC16F627A HFO PIC HFO board USB or RJ11 PIC18F2420 Power board PIC Power board RJ11 PIC18F2520 Blender PIC Blender board ICSP dsPIC33FJ128GP706 55 / 84 SM fabian-HFO- 1.17.docx fabian HFO Servicemanual 10.1 Required tools for SW update USB Stick for upgrade the following modules : - HMI Interface Controller PIC Monitor PIC HFO PIC Processor programmer: “ICD 3” “ or “Softlog” Programmer with ICSP Adapter, Windows PC ( XP or Windows 7 ) with installed MBLAP ( ICD3) or ICP (Softlog) Software for upgrade the following modules: - Alarm PIC Power board PIC Blender PIC Microchip ICD 3 programmer Softlog portable programmer ( available from Acutronic # 7215 ) PICkit 3 programmer ( available from Acutronic # 7327 ) After an update a calibration of the device is mandatory 56 / 84 SM fabian-HFO- 1.17.docx fabian HFO Servicemanual 10.2 Software update See Document: fabian update instruction 10.3 Configure USB update ( AcuInstall.ini ) On the USB update stick in the folder: \SETUP\ you will find the file: AcuInstall.ini With help of this file, the update process can be adjusted. There are the following settings are available: MANUAL: enables the manual installation, does not read the [CONFIGURATION] AUTO: installs the update using the current configuration of NetDCU, does not read the [CONFIGURATION] CONFIG: installs the update with new configuration settings of [CONFIGURATION] COLDBOOT: for production or a complete first installation DISPLAYCAL: calls only the display calibration, does not read the [CONFIGURATION] Open the file with an editor program. Look for this entry: INSTALLTYPE= Change the entry after “Installtype=” Save the new Acuinstall.ini Perform the update 57 / 84 SM fabian-HFO- 1.17.docx fabian HFO Servicemanual 10.4 Processor port connections 10.4.1 PIC Connector Mainboard Blender / Alarm and Power board processors cannot be updated by USB. To update the PIC you need a ICD3 or Softlog Programmer. The following pictures show the connections of the processors. 58 / 84 SM fabian-HFO- 1.17.docx fabian HFO Servicemanual 10.4.2 PIC Connector Blender PIC Processor Blender PCB rev.1.0 PIC Processor Blender PCB rev.1.1 / 1.2 59 / 84 SM fabian-HFO- 1.17.docx fabian HFO Servicemanual 10.4.3 PIC Connector Power board 60 / 84 SM fabian-HFO- 1.17.docx fabian HFO Servicemanual 10.4.4 PIC Processor upgrade See Document: Processor update instruction 61 / 84 SM fabian-HFO- 1.17.docx fabian HFO Servicemanual 11) Tools / Repair Info 11.1 Alarms OFF During repair and troubleshooting it is possible to disable the system and patient alarms. Simultaneously press and In the upper right corner the symbol , hold for approx. 5 sec. will appear. From now on ALL alarms are disabled till you press the buttons again or restart the Unit. 11.2 Required Tools - Philips screwdriver PH 1 - Philips screwdriver PH 2 - Torx Screwdriver TX 20 - Screwdriver size 0.8 - Allen key 4 mm / 8 mm - Socket key 5 mm & 6 mm - ESD set 62 / 84 SM fabian-HFO- 1.17.docx fabian HFO Servicemanual 11.3 Holding device The holding device is required for the exchange of HFO module. If not used, the front frame will break Holding device Part.Nr.:: 7219 Mounted holding device fabian HFO turned 63 / 84 SM fabian-HFO- 1.17.docx fabian HFO Servicemanual 12) Repair / HW upgrade instruction 12.1.1 Exchange of fuses General note: Fuses shall be replaced by fuses of the same type and value indicated on fabian only. ACUTRONIC Medical Systems AG recommends the exchange of fuses by authorised service personnel only. The main fuses are located in the fuses compartment of the power entry module at the rear panel of fabian. Procedure: 1. Disconnect power cord from machine to avoid electrical shock! 2. With a forceps, open the fuses compartment. Pull out the drawer, which contains the fuses. 3. Exchange the fuses with fuses of the same type and value. 4. Install the compartment back. 5. Make sure, that the arrow directs to the right side. 6. The correct values for the fuses are indicated on the label above the power entry module. 64 / 84 SM fabian-HFO- 1.17.docx fabian HFO Servicemanual 12.1.2 Replacing Air and O2 inlet filters 1) 2) 3) 4) Unscrew the 4 mm Allen screw inside the compressed air and oxygen connection. Remove the filter Install a new filter. Install the retaining screw. The NEW filter Part. No.: 3697 can be used for ALL fabian devices 65 / 84 SM fabian-HFO- 1.17.docx fabian HFO Servicemanual 12.1.3 Replacing Oxygen sensor Switch off fabian HFO. Loosen 3 screws on fabian housing cover. Lift off housing cover. The oxygen sensor is located at the front right inside the fabian, viewing from the back. Unplug oxygen sensor cable. Unscrew oxygen sensor counter-clockwise. Screw in new sensor and connect sensor cable. Reinstall housing cover. Switch on Fabian. Calibrate oxygen sensor at 21 %Vol. and 100 %Vol. 66 / 84 SM fabian-HFO- 1.17.docx fabian HFO Servicemanual 12.1.4 Replacing the exhalation valve membrane ! Make sure the membrane is correctly aligned ! 67 / 84 SM fabian-HFO- 1.17.docx fabian HFO Servicemanual 12.1.5 Replacing battery pack The internal battery is maintenance free ! Under normal use the battery has no wear and tear. If a replacement is necessary please follow these steps: 1. 2. 3. 4. 5. 6. 7. Replace battery Connect mains power AND gas supply Start fabian and let the fabian run till the battery is fully charged Remove mains power supply Let the fabian run until the unit shuts off Follow steps 2 – 5 one more time Now the battery pack is ready to use 68 / 84 SM fabian-HFO- 1.17.docx fabian HFO Servicemanual 12.2 Error codes 12.2.1 Blender codes CODE PROBLEM CAUSE 0 Connection Problem - Check connection cable Blender / Mainboard 1 AIR control 2 O2 control - Proportional valve Pressure sensor Blender PCB Blender flow sensor Pressure regulator 3 Override Voltage Proportional valve - 24 Volt fail ( PIN 7,8,9 ) 4 Communication between blender / Mainboard - Blender PCB Mainboard Connection cable - 8 Hot wire Air Contact problem AIR : U101, L100, R117, 118, T101, R113 Contact problem O2 : U101, L101, R119, 120, T102, R114 Blender Flow sensor 16 Hot wire O2 - 24 - Hot wire Air AND O2 - Contact problem U101, L100, L101 Blender Flow sensor 32 FRAM / Memory check - Try to load new Software Blender PCB 64 Zero calibration - Proportional Valve ( Leak ) Blender Flow sensor - Blender PCB 128 / 160 FRAM 69 / 84 SM fabian-HFO- 1.17.docx fabian HFO Servicemanual 12.2.2 Watchdog / Software CODE PROBLEM WDST_0 User Interface WDST_1 Controller PIC WDST_2 Monitor PIC WDST_3 Alarm PIC CAUSE - Software - PIC Mainboard Multiplexer 12.2.3 Hardware Message CAUSE Safety relay defect - Mainboard Voltage monitoring - Power board Mainboard SPI Interface DIO Interface COM Interface PIF Interface I2C Interface - NetDCU Mainboard Serial Terminal interface - AcuLink communication Cooling fan defect - Cooling fan Low physical memory - please reboot! - NetDCU Battery defect - Battery Connection Battery / power board 70 / 84 SM fabian-HFO- 1.17.docx fabian HFO Servicemanual 12.3 HFO module upgrade Modification / Description: Change HFO module Rev. < 2.0 ( Amp. max. 60 mbar ) Remove the Top, right and left housing from fabian HFO Mount the holding device ( Art. No.: 7219 ) Turn the fabian HFO Remove the bottom cover Remove the complete Air tube form the blender and replace with the tube from the upgrade kit. Replace the HFO Module with the new one. Pay attention to the Hytrel tube ! You can easily remove the tube by disassembly the HFO connector. To remove the HFO connector, loose the screw which is located at the lower side of the Manifold. 71 / 84 SM fabian-HFO- 1.17.docx fabian HFO Servicemanual Reinstall the housing Stick down the label : “HFO module 2.0” Software Setup for HFO module 2.0 ( Installer 1.0.0.33 ) Start the fabian HFO with USB update stick connected. Select “ Hardware configuration “ Select “ Spring type : conical “ Followed by “done” Reboot fabian HFO - Perform a complete System check with calibration Connecting to HFO module Rev ≥ 2.0 72 / 84 SM fabian-HFO- 1.17.docx fabian HFO Servicemanual 12.4 Purge flow upgrade The following SW /FW Versions must be installed prior us of the purge flow kit. HMI Software Language Version Blender PIC Accu PIC Controller PIC Monitor PIC ≥ 1.2.0.38 ≥ 1.0.0.63 ≥ 2.5 ≥ 4.7 ≥ 3.03 ≥ 2.6.7 Modification / Description: Under certain circumstances it is possible that moisture reaches close to the proximal connector of the fabian HFO. To prevent this, the proximal port must be modified. After the modification a small continous flow from the proximal port to the Y Piece is given. pneumatic with purge flow Modification Kit ( Art. No. 7244 ) 73 / 84 SM fabian-HFO- 1.17.docx fabian HFO Servicemanual Remove the Top, right and left housing from fabian HFO Remove the tube from the blender Connect the modification Kit to blender Remove the Silicon tube from the proximal pressure sensor. Connect the new tubes to the proximal sensor as shown. 74 / 84 SM fabian-HFO- 1.17.docx fabian HFO Servicemanual Stick down the label : “purge flow” Calibrate the proximal sensor at 0 and 60 mbar. Perform a function test in all breathing modes. 75 / 84 SM fabian-HFO- 1.17.docx fabian HFO Servicemanual 13) Calibration Detailed calibration and test instruction in Document: Test instruction fabian 13.1 Calibration - tools Special test procedures and instruments are required to perform the testing. Only use test instrument which is regularly checked and calibrated by certified calibration service, to guarantee that they have the required accuracy. The following equipment is required: - Respirator tester e.g. PF300 flow analyser (IMT) - fabian test lung ( part no. 1116 ) - Test lung small ( part no.: 7204 ) - Miniature pressure regulator. Range approx. 60 mbar e.g. Aircom Art No.: R900-3,5WK - Electrical safety tester WARNING Hazardous voltages exist within the ventilator. Always observe appropriate safety precautions when working on the ventilator while the machine is connected to an electrical power source to prevent possible accidental injurious electrical shock. WARNING After calibration and/or replacement of any assembly(ies), always repeat the complete test procedure according the fabian checklist. 76 / 84 SM fabian-HFO- 1.17.docx fabian HFO Servicemanual 14) Service Mode Screens 14.1 System 14.1.1 Calibration 77 / 84 SM fabian-HFO- 1.17.docx fabian HFO Servicemanual 14.1.2 Blenderboard Flow Correction default setting is 1.000. Only change at the direction of Acutronic 78 / 84 SM fabian-HFO- 1.17.docx fabian HFO Servicemanual 14.1.3 Monitor PIC Oxy1 Data of Oxygen Cell: Oxy2 522 21 Vol%O2, Sensor new ( typical ) 435 – 626 21 Vol%O2, Sensor new ( range ) ≤ 327 Sensor nearly defect ( at 21% ) ≤ 246 Sensor defect ( at 21% ) ≥ 839 Sensor defect ( at 21% ) ≤ 1561 Sensor nearly defect ( at 100 % ) ≤ 1172 Sensor defect ( at 100 % ) ≥ 4000 Sensor defect ( at 100 % ) ≤ 65 Sensor disconnect, Cable broken P – Air Dynamic condition 2300 ± 100 ( approx. 1.6 bar ) P – O2 P insp. 0 mbar 1480 ±10 60 mbar 2940 ±10 79 / 84 SM fabian-HFO- 1.17.docx fabian HFO Servicemanual 14.1.4 Accuboard 14.1.5 Valves - Perform a “ Burn In “ after replacing the O2 calibration valves for 15 minutes. 80 / 84 SM fabian-HFO- 1.17.docx fabian HFO Servicemanual 14.1.6 Display - Same function as in the user menu 14.1.7 Settings - Switch Nursecall ON /OFF Load and save User settings 81 / 84 SM fabian-HFO- 1.17.docx fabian HFO Servicemanual 14.1.8 Interfaces 14.1.9 Info 82 / 84 SM fabian-HFO- 1.17.docx fabian HFO Servicemanual 14.1.10 Licensing The Licensing is done by Acutronic at factory side. Should it be necessary to re-enter the keys, please contact Acutronic. It is also possible to setup the keys via the update USB stick. The license key (available from Acutronic) must be located in the following directory on the USB update stick \ LICENSE Start fabian in manual update mode. 83 / 84 SM fabian-HFO- 1.17.docx fabian HFO Servicemanual 15) AcuLink / PDMS / Network connection Please find the instruction how to use : - AcuLink - PDMS - IVIO - Network In the Documentation: - acuLink Protocol Definition - acuLink IVOI Protocol Definition 16) Complete Device Check See Document: fabian Test Record 17) System - check See User manual 18) Spare parts See Document: fabian HFO Spare parts 19) Technical Specifications See User manual 84 / 84 SM fabian-HFO- 1.17.docx