Service Manual
52 Pages
Preview
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fabian therapy
Service manual Version 1.01
Manufacturer: ACUTRONIC Medical Systems AG Fabrik im Schiffli 8816 Hirzel / Switzerland Phone: Fax: E-Mail:
+41 44 729 70 80 +41 44 729 70 81 [email protected] www.acutronic-medical.ch
0124
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PREFACE ... 4 WARNINGS ... 5 SYMBOLS AND ABBREVIATIONS ... 6
CMOS HANDLING PRECAUTIONS ... 7 WARRANTY ... 7 MAINTENANCE ... 8 INTERVALS FOR MAINTENANCE ... 9 FABIAN COMPONENTS ... 11
REPAIR INSTRUCTIONS ... 17 SERVICE TOOLS ... 17 EXCHANGE OF FUSES ... 19 REPLACING AIR AND O2 INLET FILTERS ... 20 REPLACING OXYGEN SENSOR ... 21 REMOVING THE HOUSING ... 22 REPLACING THE MAINBOARD ... 24 REPLACING AIR / OXYGEN BLENDER ... 26 REPLACING INLET PRESSURE REGULATORS ... 29 REPLACING THE BACKUP LITHIUM BATTERY ... 30 REPLACING THE BATTERY CONTROLLER BOARD ... 31 REPLACING THE BATTERY PACK... 32
UPDATE ... 33 SOFTWARE UPDATE... 33 INITIAL OPERATION WITH NEW SOFTWARE ... 35 SYSTEM DIAGNOSIS ... 37 TURN OFF SYSTEM ALARMS ... 39 LOAD NEW SW ON BATTERY CONTROLLER BOARD ... 40
CALIBRATION ... 42 CALIBRATION - TOOLS... 42 CALIBRATION PRESSURE SENSOR ... 44 PROXIMAL SENSOR CALIBRATION ON THE BLENDER BOARD ... 45 CALIBRATION INPUT PRESSURE REGULATORS ... 47 COMPLETE DEVICE CHECK ... 48 TECHNICAL DATA ... 52
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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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Warnings The use of the fabian presupposes the exact knowledge and attention of this operating instruction. The equipment is intended only for the described use.
fabian shall only be used under supervision of qualified personnel to ensure, in case of a malfunction of the equipment, corrective action is taken immediately.
When using the fabian in a clinical setting, an independent ventilation method, for example, manual ventilation equipment, must be available at all times.
In the case of a visible malfunction of fabian, when its life supporting function is no longer guaranteed, fabian must be replaced immediately by an independent ventilation method such as for example a manual resuscitator.
Never use fabian in combination with flammable anaesthetics. fabian is designed for use with air and oxygen only.
Acoustic and visible alarms indicate either a patient or a system alarm and require immediate intervention of qualified medical personnel.
If during the self-check or system test a failure or malfunction is recognised, under no circumstances fabian should be used on a patient.
The use of fabian in conjunction with electrical or electronic equipment others than those mentioned in this manual are not permitted. Contact ACUTRONIC Medical Systems AG in case of special request.
It is not allowed to cover or to set up fabian so that its operation is influenced negatively.
Disconnect power cord before open the housing.
To avoid any malfunctions of fabian based on radio frequency, do not use any cellular phone closer than 10m to it. Mobile phones may cause malfunctions to medical equipment.
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It is not allowed to use antistatic or electrically conductive hoses.
Symbols and Abbreviations Symbol
Description Read instructions for use
To consider
Before opening the housing disconnect power cord
General warning
Warning of in flammability
Warning of electrical injury
Do not cover
Do not use mobile phones
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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
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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Maintenance fabian is a Neonatal and Infant Ventilator and classified as Il b according all applicable requirements for th 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 6 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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Intervals for Maintenance fabian and accessories must be cleaned and sterilised prior any maintenance or repair work, also in case of returning fabian to ACUTRONIC Medical Systems AG.
Every 6 month
-
Maintenance and electrical safety check with protocol (EN 62353) Check alarm limits for proper function Check connections for air and oxygen (Leakage test) Check mechanical and electrical connections Calibration
-
Maintenance and electrical safety check with protocol (EN 62353) Check alarm limits for proper function Check connections for air and oxygen (Leakage test) Check mechanical and electrical connections Calibration
-
O2-Sensor O2 inlet filter Air inlet filter
Every 12 month
( Art.No.: 7003 ) ( Art.No.: 3697 ) ( Art.No.: 3697 )
If O2-Sensor alarm is displayed, the sensor must be replaced at earliest convenience to assure a proper function of apparatus. Disposal of old sensor like battery according local rules.
Every 3 years
-
Air / Oxygen blender Input pressure regulators Lithium battery (coin) Battery Pack
(Art. No.: 7078 ) if working hour > 10.000 h (Art. No.: 7025 ) (Art. No.: CR2450) (Art. No.: 7036)
Repairs and general overhaul of fabian shall be carried out by ACUTRONIC Medical Systems AG trained and authorised service personnel only.
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WARNING Hazardous voltages exist within the ventilator. Always observe appropriate safety precautions when workings 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.
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fabian components Rear side
1
Main power supply 100 – 240 V AC Connector for external power supply 12 - 24 V DC
2
3
Earth connection
4
RS 232 serial port
5
Air gas input 2.0 – 6.5 bar
6
Input pressure regulator Air
7
O2 Sensor compartment
8
Input pressure regulator OXYGEN
9
Oxygen gas input 2.0 – 6.5 bar
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Connections frontpanel
Mainboard
PC / 104 board
Proximal pressure sensor
Connection powermodule
Loudspeaker
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PC / 104 board
System EPROM LO
System EPROM HI
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PIC processor
PC / 104 board
Parallel PIC 40 DIP monitoring processor Serial PIC 28 DIP controller processor
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Battery module
Battery controller board
Battery pack
Power Supply
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REPAIR INSTRUCTIONS Service Tools
Some steps are equal to fabian + nCPAP. This is the reason for some fabian + nCPAP Pictures in this Service manual. Required Tools: - Philips screwdriver PH1 - Philips screwdriver PH2 - Screwdriver size 1 - Allen key 4 mm - Socket key 5 mm & 5.5 mm - IC extractor - ESD set - Screwdriver for potentiometer adjustment - Gripper
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ESD Set:
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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.
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Replacing Air and O2 inlet filters
1.) Unscrew the 4mm Allen screw inside the compressed air and oxygen connection.
2.) Remove the filter by tilting the unit backwards. 3.) Install a new filter. 4.) Install the retaining screw.
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