Fukuda CardiMax 2 Service Manual Download Page 2

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Fukuda Denshi Co., Ltd.
3-39-4 Hongo, Bunkyo-ku, Tokyo, Japan

2017 Fukuda Denshi Co., Ltd.

No part of this document may be reproduced or transmitted in any form without the prior written

permission of Fukuda Denshi Co., Ltd.
If this manual has pages missing or out of order, contact Fukuda Denshi for replacement.

●

Only physician or persons instructed by physicians are allowed to use the equipment.

●

The information contained in this document is subject to change without notice due

to improvement in the equipment.

CAUTION

Fukuda Denshi UK
Unit 7, Genesis Business Park, Albert Drive, Woking, Surrey GU21 5RW, United Kingdom

This device bears the CE label in accordance with the provisions of Medical Device Directive
93/42/EEC.

This device bears the CE label in accordance with the provisions of RoHS Directive 2011/65/EU.

Summary of Contents for CardiMax 2

Page 1: ...ELECTROCARDIOGRAPH Service Manual Before installation maintenance read this service manual thoroughly After reading this service manual store it in a safe place ...

Page 2: ... Only physician or persons instructed by physicians are allowed to use the equipment The information contained in this document is subject to change without notice due to improvement in the equipment CAUTION Fukuda Denshi UK Unit 7 Genesis Business Park Albert Drive Woking Surrey GU21 5RW United Kingdom This device bears the CE label in accordance with the provisions of Medical Device Directive 93...

Page 3: ...1 Model Name FX 8200 Service Manual Revision History Edition Revised Items Reason of the Revision Revised Date 1 New Edition June 2017 bl5928 ...

Page 4: ...2 ...

Page 5: ...dical Electrical Equipment vi Precautions Concerning the LAN viii Storage Transportation and Disposal ix Cleaning and Disinfection x Precautions for Safe Operation under Electromagnetic Influence x EMC Guidance xi Chapter 1 General Description Features of this ECG 1 1 Names of Parts and Their Functions 1 1 Types and Functions of Operation Panel Keys 1 3 Specifications 1 4 Chapter 2 Operational Des...

Page 6: ...lock 2 2 5 7 Lower Case Block 5 8 General Assembly Diagram 5 10 External Appearance 5 10 Removing the Lower Case 5 11 Removing the Recorder Block 5 12 Removing the CPU Board 5 13 Removing the Power Supply Unit 5 14 Removing the LCD 5 15 Chapter 6 Software Update Software Updating Procedure 6 1 Chapter 7 Troubleshooting When Malfunction Occurs 7 1 When the ECG Waveform is Unstable 7 1 When the Equi...

Page 7: ... 8 9 AMP Status 8 10 Adjust Perforations 8 10 MAC Address 8 11 Adjust Touch Panel 8 11 Screen Capture 8 11 Backup Battery Replacement 8 12 Main Battery 8PH 4 3A3700 H J18 Replacement 8 13 Replacement of Display Unit Backlight 8 15 Motor Replacement 8 16 Thermal Print Head Replacement 8 17 Adjusting the Thermal Recorder 8 17 Cleaning and Disinfecting 8 19 Cleaning the Equipment 8 19 Cleaning the Ac...

Page 8: ...is applied to SIP SOP 9 7 Patient Leakage Current When external voltage is applied to patient connection of Type F Applied Part 9 8 Patient Auxiliary Current 9 8 Replacement of the Accessories 9 8 Replacement Period of Consumable Parts 9 8 Chapter 10 Appendix Combination Example of Medical and Non Medical Equipments 10 1 Check List 10 1 ...

Page 9: ... Equipment iii Safety iv Precautions when Using with Other Equipment iv Optional Accessories v Application to Heart vi Connecting the Power Cable vi Leakage Current vi Precautions for Safe Operation of Medical Electrical Equipment vi Precautions Concerning the LAN viii Storage Transportation and Disposal ix Cleaning and Disinfection x Precautions for Safe Operation under Electromagnetic Influence ...

Page 10: ...Contents ...

Page 11: ...lly to ensure correct and safe use of the FX 8200 Make sure to follow the warnings and precautions indicated below as these are important messages related to safety DANGER Do not make changes to the medical electronic equipment Otherwise the safety of FX 8200 cannot be ensured and the patient or the operator may be exposed to dangerous situation Chapter Title Description Preface Introduction Preca...

Page 12: ...attery terminal Please handle FX 8200 according to the FX 8200 operation manual Please refer to the operation manual for precautions for use Safety Notations The following safety notations are used throughout this manual Each of these notations has a different meaning as shown below Read the following information thoroughly to ensure proper correct and safe use of the product An Example of Safety ...

Page 13: ...age the labels Symbols on the Equipment The following is a list of symbols used on this equipment bl5635 bl5636 Indicates failure to observe the instructions in this manual may pose a risk to the operator or the patient Indicates the relevant accompanying documents need to be referred to before operation Indicates a matter of Danger Warning that calls attention for safety General Precaution Indica...

Page 14: ...quipment is in safe operating conditions at all times and prevent potential future problems Perform preventive maintenance at least once every three months Inspect the main unit and all connectors and cables for any external damage Perform maintenance if one of the following should occur Do not repair or perform maintenance when the equipment is in use When the equipment gets a strong impact due t...

Page 15: ...siderably different depending on the electrode position and surgery site Place the ECG electrodes as far away as possible from the surgery site and the ground plate Plug the electrosurgical instrument into a hospital grade outlet as far away as possible from the outlet of this equipment This will reduce interference from the electrosurgical instrument While using a high frequency surgical device E...

Page 16: ...needs to be below the allowable limit for safety purposes Follow the instructions in the operation manual of the pacemaker or other heart equipment using electrical stimulation When using this device with other devices perform equipotential grounding to prevent potential difference between the devices If potential difference occurs between the devices danger may result to the patient and operator ...

Page 17: ...overheating or explosion may occur Inspections Perform daily checks to maintain safety Perform periodic checks once a year to maintain safety Check all cables equipment accessories earth impedance leakage current and accuracy User should have a thorough knowledge of the operation before using this system For installation and storage of the equipment pay attention to the following Install or store ...

Page 18: ...uch as damage or loss of ECG data The warranty does not cover data retrieval or repair that is required when problems such as these are caused by using unspecified items When the specified media is inserted corresponding icon will be displayed on the status display area Do not remove media while data is being saved to the media The data may become unreadable This may include the data that was alre...

Page 19: ...the parts or into the circuit of the wireless LAN adapter which may damage the wireless LAN adapter Make sure to follow the precautions below to protect the wireless LAN adapter and this equipment from damage caused by static electricity Remove static electricity from the body before using Hold the end of the wireless LAN adapter when handling it Never touch the metal part of the wireless LAN adap...

Page 20: ...ng element System products Clean the connected equipments according to the instructions in their respective manuals Precautions for Safe Operation under Electromagnetic Influence Measures to ensure Electromagnetic Compatibility EMC While this device complies with the IEC60601 1 2 2007 AC 2010 and IEC 60601 2 25 2011 safety standards malfunctions may occur if there are strong electromagnetic waves ...

Page 21: ...oise interference on the waveform or failure to the peripheral device occurs stop using the equipment and follow the instruction of the technical engineer The following is the information relating to EMC Electromagnetic Compatibility When using the FX 8200 verify that it is used within the environment specified below Compliance to the Electromagnetic Emissions The FX 8200 is intended for use in th...

Page 22: ...nvironment Surge IEC 61000 4 5 0 5 1kV Differential Mode 0 5 1 2kV Common Mode 0 5 1kV Differential Mode 0 5 1 2kV Common Mode Mains power quality should be that of a typical commercial or hospital environment Power supply input lines fluctuation in input supply line IEC 61000 4 11 For 0 5 cycles 5 UT 95 UT drop For 5 cycles 40 UT 60 UT drop For 25 cycles 70 UT 30 UT drop For 5 seconds 5 UT 95 UT ...

Page 23: ...may occur in the vicinity of equipment marked with the following symbol Note 1 At 80MHz and 800MHz the separation distance for the higher frequency range applies Note 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a Field strengths from fixed transmitters such as base stations for radio cell...

Page 24: ...evel Compliance Level Electromagnetic Environment Guidance Incision mode Output power 300 W Output power 300 W When an electrosurgical instrument generates high frequency energy the noise level of the displayed recorded waveforms increase but it returns to original level within 10 seconds If the waveforms during the generation of high frequency energy are analyzed effective analysis result may not...

Page 25: ... 1 Chapter 1 General Description Contents Chapter 1 General Description Features of this ECG 1 1 Names of Parts and Their Functions 1 1 Types and Functions of Operation Panel Keys 1 4 Specifications 1 5 ...

Page 26: ...Chapter 1 General Description Contents ...

Page 27: ...pplied lead cable The use of a lead cable other than the specified defibrillation proof type may damage the equipment or compromise safety when the equipment is used along with a defibrillator CAUTION Do not bend drop or apply impact to the USB memory Do not apply impact to the equipment while the USB memory is in operation It may damage the data or break the media Do not touch the terminal parts ...

Page 28: ...ht in orange 5 Control Panel Buttons for turning ON OFF the power or starting the ECG recording are located 6 LCD Monitor Displays ECG waveforms and patient information NOTE Although the color LCD utilizes highly advanced technologies occasionally there may be a few pixels which do not light dots or constantly light Temperature changes may also cause some irregularities due to the characteristics ...

Page 29: ...onnectors 1 to 2 Connects a USB memory optional or external device such as a barcode reader NOTE Do not unplug a USB memory or turn OFF the power while the USB memory is in operation 11 AC Power Supply Connector Connects the power cable To disconnect from the power source unplug the power cable from this connector 12 Potential Equalization Terminal Connects an equipotential line 13 Battery Inserti...

Page 30: ...ower Hold down the button 2 seconds or longer to turn off 2 Lead Key Changes the lead during an ECG examination Moves the cursor to left or right while typing 3 Sensitivity Key Changes the sensitivity during an ECG examination 4 Reset Key Resets the waveforms 5 1mV key Inserts a calibrated waveforms 6 Review key Starts stops printing a review during an ECG examination 7 Start Stop key Starts stops...

Page 31: ...ignal Suppression 103 dB and above 2 mm p p and below at sensitivity level 1 Leads Standard 12 lead Lead selector Error within 5 Skew between leads 0 sec Noise level 30μV p p and below input conversion Filter AC filter 20 dB or less at 50 Hz or 60 Hz Muscle filter 3 dB 6 dB oct or less at 35 Hz or 25 Hz Drift 3 dB 6 dB oct or less at 0 25 Hz or 0 5 Hz Printing Thermal Head Method Printing Speed 5 ...

Page 32: ...nal power supply equipment Type CF Applied Part Cardiac defibrillator recovery time Within 10 seconds Power Supply AC power 100 240 V AC 50 60 Hz DC power 9 6 V DC Battery pack Power Consumption 70 VA AC 40 W DC On board 12 V power supply Unusable Dimensions Approximately 260 mm W 206mm D 66mm H Weight Approximately 1 8 kg main unit only Approximately 2 3 kg including options such as battery and w...

Page 33: ...2 Operational Description Contents Chapter 2 Operational Description Hardware Overview 2 1 Operational Description 2 1 Primary Power Source 2 1 CPU Board 2 2 ECG Input Unit 2 6 Operation Panel Touch Panel Unit 2 6 ...

Page 34: ...Chapter 2 Operational Description Contents ...

Page 35: ... the jumper setting or switch position on the main unit board The equipment operation may become unstable or may cease Operational Description Primary Power Source The functional block diagram of the primary power source is shown below 90 V AC to 264 V AC can be input to the primary power source 18 V DC is output by rectification and switching control bl5929 Patient DMS Battery Electrocardiopraph ...

Page 36: ...d through the operation panel The external monitor is connected through the connector board USB Communication Controls the USB memory communication LAN Communication Controls the 10 100Base T compliant LAN communication Sound Controls the speaker generating a warning tone etc Connects to the speaker bl5931 LAN USB x 3 CPU Board CPU i MX515 800MHz DDR2 FPGA Motor Driver Local And Power Supply Contr...

Page 37: ...Unit The block diagram of the bus I F unit is shown below The main bus is connected to the FPGA and FLASH ROM and has a bus width of 16 bits DDR2 SDRAM is connected to the SDRAM dedicated 32 bit bus 㻡㼂㼋㻿㼀㻮㻗㻤㻚㻜䡚㻗㻥㻚㻢㼂㻰㻯㻟㻚㻟㼂㻡㼂㻺㼕㻹㻴㻌㼏㼔㼍㼞㼓㼑㼞㻌㼣㼕㼠㼔㻌㻿㼥㼟㼠㼑㼙㻌㻼㼛㼣㼑㼞㻌㻿㼑㼘㼑㼏㼠㼛㼞㻠㻌㻯㼑㼘㼘㻌㻺㼕㻹㻴㻰㻯㻛㻰㻯㻌㻞㻚㻜㻭㻰㻯㻛㻰㻯㻌㻠㻚㻡㻭㻰㻯㻛㻰㻯㻌㻟㻚㻜㻭㻰㻯㻛㻰㻯㻌㻝㻚㻢㻚㻭㻰㻯㻛㻰㻯㻌㻜㻚㻤㻭㻰㻯㻛㻰㻯㻌㻜㻚㻤㻭㻸㻰㻻㻌㻜㻚㻞㻭㻸㻰㻻㻌㻜㻚㻞㻭㻸㻰㻻㻌㻞㻜㼙㻭㻗㻝㻤㼂㻰㻯㻞㻠㼂㻝㻚㻞㻞㻡㼂㼋㻯㻼㼁㻝㻚㻤㼂...

Page 38: ...by ceasing the data transmission and thermal print head strobe signal Motor Drive Unit The block diagram of the motor drive unit is shown below The motor is controlled as follows The CPU sets the printing speed data for the FPGA When paper end or tray up is not detected FPGA outputs the motor pulse to the motor driver based on the set data The motor driver drives the stepping motor with the freque...

Page 39: ... The block diagram of the USB I F unit is shown below The USB I F unit has a full speed compliant circuit for three ports A data communication with the CPU is performed via dedicated transceiver Communication with each port is performed by USB hub device A USB power control device is mounted to protect against overcurrent When overcurrent is detected the power supply to the USB device is ceased an...

Page 40: ...P block is electrically isolated by photo isolater and isolation power Operation Panel Touch Panel Unit The block diagram of the operation panel touch panel unit is shown below A resistive touch panel is used The touch panel is a 7 inch 4 wire type and transmits the data to the CPU by the touch controller with I2C I F The key data of operation panel is transmitted to the CPU with I2C I F The statu...

Page 41: ...3 1 Chapter 3 Wire Connection Diagram Block Diagram Contents Chapter 3 Wire Connection Diagram Block Diagram Wire Connection Diagram 3 1 Block Diagram 3 2 Pin Arrangement of External Connector 3 3 ...

Page 42: ...Chapter 3 Wire Connection Diagram Block Diagram Contents ...

Page 43: ...nnection Diagram Block Diagram Wire Connection Diagram Chapter 3 Wire Connection Diagram Block Diagram Wire Connection Diagram The connection diagram of FX 8200 is shown below bl5934 PCB 7798 TRAY UP TO ALTERA TRAY UP SENS ...

Page 44: ...let Cable Primary Power Source Cable between power source and CPU board CPU BOARD PCB 7785 FPGA NiMH Battery OP AMP ADC Flash RTouch C N Isolator Charge Circuit CLK Motor Driver C N Recorder Sensor ASSY THERMAL 110mm 8dot mm STEPPING MOTOR Mark Sensor Board PCB 7798 Paper Tray Up Sensor Board PCB 6862 RECORDER UNIT Sensor I F Driver Thermal I F Circuit Recorder I F Circuit RTC Lithium Battery Key ...

Page 45: ...tial data output 3 RXD 10 BASE T received differential data output 4 NC 5 NC 6 RXD 10 BASE T received differential data output 7 NC 8 NC Pin No Signal Name Remarks 1 VBus Power supply 5 V 2 DATA Differential data I O 3 DATA Differential data I O 4 GND Ground DG Pin No Signal Name Remarks 1 VBus_1 Power supply 5 V 2 DATA_1 Differential data I O 3 DATA_1 Differential data I O 4 GND_1 Ground DG 5 VBu...

Page 46: ... CN15 ECG Model RDAG1 15SE1 Pin No Signal Name Remarks 1 RXD Received data input 2 TXD Transmitt data output 3 5V 4 GND Ground DG Pin No Signal Name Remarks 1 C2 Chest C2 2 C3 Chest C3 3 C4 Chest C4 4 C5 Chest C5 5 C6 Chest C6 6 RE 7 NC 8 NC 9 R Right arm 10 L Left arm 11 F Left leg 12 C1 Chest C1 13 NC 14 RF Right leg 15 NC ...

Page 47: ...4 1 Chapter 4 Spare Parts List Contents Chapter 4 Spare Parts List ...

Page 48: ...Chapter 4 Spare Parts List Contents ...

Page 49: ...C015732 LCD Support 1 6C015733 ECG Shield Cover 1 6C015734 LCD Lid 162 mm 2 6C015735 LCD Lid 100 mm 2 6C015677 LCD Support Plate 1 6C015678 Recorder Shield Plate 1 6C015737 Potential Equalization Terminal Cover 1 1K001800 Potential Equalization Terminal POAG S6 15 1 6C015761 Shielding Gaskets STGPF2 10 8 mm 1 1Z010527 Core HF70SH41X08X12 1 9H011499 Lower Case SU 1 6C015714 Recorder Sheet 1 6C01571...

Page 50: ...SU 1 9H011506 Hook Holder A SU 1 6C015706 Hook Holder B 1 6C015707 Paper Guide 1 6C015708 Paper Tray Attachment Shaft 1 6C015709 Paper Cutter 1 6C015710 Motor Mounting Bracket 1 6C015711 Soft Gasket UC 300284 V O 15mm 1 6C015760 Shielding Gaskets STGPF8 8 10 mm 1 5T010029 Polystyrene Washer STW FT60 0 25 2 5T010028 Polystyrene Washer STW FT30 0 25 1 6C015722 Brass Spacer BSB 2607 2 5T007004 E Ring...

Page 51: ...5 2 Recorder Block 1 3 5 3 Recorder Block 2 3 5 4 Recorder Block 3 3 5 5 Upper Case Block 1 2 5 6 Upper Case Block 2 2 5 7 Lower Case Block 5 8 General Assembly Diagram 5 9 External Appearance 5 10 Removing the Lower Case 5 11 Removing the Recorder Block 5 11 Removing the CPU Board 5 12 Removing the Power Supply Unit 5 14 Removing the LCD 5 14 ...

Page 52: ...Chapter 5 Disassembly and Assembly Procedure Contents ...

Page 53: ...ure Power Supply Block 6 Potential Equalization Terminal Cover 1 5 Grounding Plug POAG S6 15 1 Common with FX 8222 4 Cable between power supply and CPU board 1 3 AC Inlet Cable 1 2 Power Supply Unit SNP GK65 MG 1 1 Power Supply Plate 1 No Item Model Type Q ty Remarks bl6735 2 Double washer sems M3 x 8 2 M6 Nut ...

Page 54: ...r Support SU 1 8 Platen Roll 1 7 Gear B 1 6 DDL 1150ZZRP0P25LY551 2 5 Shaft for Hook Attachment 1 4 Spring for Buttons 1 3 Push Button SU 1 2 Hook 2 1 Paper Tray 1 No Item Model Type Q ty Remarks bl6736 2 E type retaining rings Nominal diameter 4 2 E type retaining rings Nominal diameter 3 ...

Page 55: ...e Screw 2 5 Thermal Print Head Fixed Color 1 4 Thermal Print Head Fixing Shaft 1 3 Spring B for Thermal Print Head 1 2 Platen Roller Guide Plate SU 1 1 Recorder Base SU 1 No Item Model Type Q ty Remarks bl6738 2 Double washer sems M3 x 8 2 Double washer sems M3 x 6 2 Double washer sems M2 6 x 5 E type retaining ring Nominal designation 2 E type retaining ring Nominal designation 2 5 Glass cloth ad...

Page 56: ...ecorder Block 2 3 6 BSB 2607 Brass Spacer Hexagon 2 5 Hook Holder B 1 4 Hook Holder A SU 1 3 Mark Sensor Paper Tray Up Sensor Cable ASSY 1 2 Paper Guide 1 1 Paper Case SU 1 No Item Model Type Q ty Remarks bl6739 2 Double washer sems M2 6 x 5 2 Double washer sems M2 6 x 5 ...

Page 57: ...ps Screwdriver 2 5 Paper Cutter 1 4 Paper Tray Attachment Shaft 1 3 Recorder Block 2 3 1 2 Recorder Block 1 3 1 1 Paper Tray Block 1 No Item Model Type Q ty Remarks bl6740 Double washer sems M2 6 x 5 Double washer sems M2 6 x 5 2 E type retaining rings Nominal designation 3 2 Flat head screws M3 x 6 ...

Page 58: ...Gaskets STGPF2 10 8 mm 1 8 LCD Lid 100 mm 2 7 LCD Lid 162 mm 2 6 LCD Support Plate 1 5 LCD Support 1 4 RFF70ZG AIW DNS 1 3 Power Supply Block 1 2 FM AP08 165A B 1 1 Upper Case SU Export 1 No Item Model Type Q ty Remarks bl6741 P type Nominal designation 3 x 10 P type Nominal designation 3 x 10 4 P type Nominal designation 3 x 10 ...

Page 59: ... 2 6 Shielding Gaskets STGPF8 8 10 mm 1 5 ECG Shield Cover 1 4 PCB 7785 ASSY 1 3 Recorder Shield Plate 1 2 Recorder Block 3 3 1 1 Upper Case Block 1 2 1 No Item Model Type Q ty Remarks bl6742 3 P type Nominal designation 3 x 10 3 P type Nominal designation 3 x 10 Double washer sems M3 x 8 ...

Page 60: ...er Case Block 7 Screw Retaining Washer TM 147 1 2 6 Rubber Foot 4 5 Cushioning Material 32 x 65 1 4 Battery Cover 1 3 Recorder Sheet 1 2 Paper Sheet 1 1 Lower Case SU 1 No Item Model Type Q ty Remarks bl6744 2 P type Nominal designation 3 x 10 2 Double washer sems M3 x 8 ...

Page 61: ... Assembly Diagram 6 FX 8200 EXP Rating Label with number assigned 1 5 Follow Operating Instructions Mark Label 1 4 Caution Mark Label 1 3 Caution Label Battery 1 2 Lower Case Block 1 1 Upper Case Block 2 2 1 No Item Model Type Q ty Remarks bl6745 5 P type Nominal designation 3 x 10 ...

Page 62: ...5 10 Chapter 5 Disassembly and Assembly Procedure External Appearance External Appearance bl5947 206 10 mm 66 10 mm 260 10 mm ...

Page 63: ...river 2 1Remove five screws P tight with washer head M3x10 on the bottom side of the main unit and remove the lower case Removing the Recorder Block Tool Phillips Screwdriver 2 1Disconnect the cables connected to the CPU board Thermal Flexible Cable Motor Cable Mark Sensor Paper Tray Up Sensor Cable ASSY bl5948 bl5950 ...

Page 64: ...rd 2Remove four screws P tight with washer head M3x10 and remove the recorder block Removing the CPU Board Tool Phillips Screwdriver 2 1Disconnect the flexible cables connected to the CPU board Key Sheet Flexible Cable LCD Flexible Cable Touch Panel Flexible Cable bl5949 ...

Page 65: ... Disassembly and Assembly Procedure Removing the CPU Board 2Remove five screws P tight with washer head M3x10 3Lift up the CPU board to disconnect the cable between power supply and CPU board and remove the CPU board ...

Page 66: ...Tool Phillips Screwdriver 2 1Remove one screw P tight with washer head M3x10 and remove the power supply part 2Remove two screws double washer sems M3x8 and remove the power supply unit Removing the LCD Tool Phillips Screwdriver 2 1Remove five screws P tight with washer head M3x10 and remove the LCD bl5951 bl5953 ...

Page 67: ...6 1 Chapter 6 Software Update Contents Chapter 6 Software Update Software Updating Procedure 6 1 ...

Page 68: ...Chapter 6 Software Update Contents ...

Page 69: ...tion of the main unit or USB memory or software update may not be possible When updating the software make sure to operate with AC power supply 1Insert the USB memory containing the software update program into USB memory slot 1 2Turn ON the power while pressing the LEAD key on the operation panel 3The installation screen will be displayed When the message Installation complete is displayed discon...

Page 70: ...6 2 Chapter 6 Software Update Software Updating Procedure ...

Page 71: ...er 7 Troubleshooting When Malfunction Occurs 7 1 When the ECG Waveform is Unstable 7 1 When the Equipment does not Operate 7 1 Messages and Remedies 7 2 Battery 7 2 File 7 3 Hardware Trouble 7 3 Trouble at Startup 7 4 Trouble during Operation 7 5 ...

Page 72: ...Chapter 7 Troubleshooting Contents ...

Page 73: ...ughly wiped with alcohol swab and cleaned with a skin cleaner Are the electrodes within expiration date and electrode gel not dried If expired or dried use new electrodes Are proper electrodes used New and old electrodes or different types of electrodes should not be mixed up Are the electrodes attached to the correct positions NOTE If the electrode attachment is loose or if the cable is pulled no...

Page 74: ...ot performed within the specified duration Turn the power OFF and then turn it back ON Battery is running low Please recharge the battery During battery operation the power will automatically turn OFF when the battery capacity becomes low Connect the power cable to switch to AC power operation or charge the battery Cannot record due to low battery voltage The printing could not be started due to l...

Page 75: ...sage is displayed the data is not saved Insert a new media and save the data again Cannot store data Failed to save the data to the media The failure of the media can be considered Write down the error code at the end of the message and contact your local Fukuda Denshi service representative Please set media The media is not set Set the media Failed to read from the file Failed to read the data fr...

Page 76: ...supplied Key Sheet Replace the key sheet 6C0156790 Power ON circuit is not functioning Key Sheet Replace the key sheet 6C0156790 Power ON signal is not transmitted to CPU PCB 7785 Replace the PCB 7785 9F0110900 The system does not activate with a battery Battery Capacity Shortage Battery Capacity Charge the battery Replace the battery 1U000337D Disconnection of Battery Cable Battery Replace the ba...

Page 77: ...B 7785 9F0110900 Noise is interfering to the ECG waveform Specific lead Disconnection of lead cable shielded wire Lead cable Replace the lead cable 9D011664C ECG Amp Failure ECG Amp Circuit Replace the PCB 7785 9F0110900 AD Converter Circuit Failure AD Converter Circuit Replace the PCB 7785 9F0110900 Lead OFF is detected Lead OFF is not detected Disconnection of Lead Cable Lead cable Replace the l...

Page 78: ...d Replace the PCB 7785 9F0110900 Noise is interfering to the ECG waveform Specific lead Disconnection of lead cable shielded wire Lead Cable Replace the lead cable 9D011664C ECG Amp Failure ECG Amp Circuit Replace the PCB 7785 9F0110900 AD Converter Circuit Failure AD Converter Circuit Replace the PCB 7785 9F0110900 Lead OFF is detected Lead OFF is not detected Disconnection of Lead Cable Lead Cab...

Page 79: ...r is not correct The backup battery is depleted Backup Battery Replace the backup battery 1U0002210 Refer to Backup Battery Replacement12 RTC IC Failure RTC Replace the PCB 7785 9F0110900 Fuse is blown Circuit Failure PCB 7785 Replace the PCB 7785 9F0110900 Fuse Failure Fuse Replace the power supply unit 1T010131A Power does not turn OFF Power OFF Circuit Failure Key Sheet Replace the key sheet Fr...

Page 80: ...7 8 Chapter 7 Troubleshooting Hardware Trouble ...

Page 81: ...8 LCD Brightness Adjustment 8 9 Self Diagnosis Manufacturer Maintenance 8 9 Manufacturer Maintenance Menu 8 9 AMP Status 8 10 Adjust Perforations 8 10 MAC Address 8 11 Adjust Touch Panel 8 11 Screen Capture 8 11 Backup Battery Replacement 8 12 Main Battery 8PH 4 3A3700 H J18 Replacement 8 13 Replacement of Display Unit Backlight 8 15 Motor Replacement 8 16 Thermal Print Head Replacement 8 17 Adjus...

Page 82: ...Chapter 8 Maintenance Contents ...

Page 83: ...Touch Back to return to the menu display Test Pattern Waveform Select an ECG test pattern waveform to be used for operation check and demonstration 1Select Simulator Waveform on the Maintenance menu The screen to select the test pattern waveform will be displayed Simulator Waveform Set Date Time Display Status General Test 1 General Test 2 Key Test Sound Test LCD test Thermal Printing Test Touch P...

Page 84: ...pattern information will not be backed up When the power is turned ON or when the setting is initialized the test pattern will not be output Date Time Set the date time 1Select Set Date Time on the Maintenance menu 2Touch Set Date Time Pattern Description Pattern 1 Normal Waveform Pattern 2 Myocardial Infarction Pattern 3 Extrasystole Pattern 4 Brugada Type Pattern 5 Brugada Risk bl5964 1 2 ...

Page 85: ...ntenance 3Set the year month day time and touch Status Display Battery status etc can be checked 1Select Status Display on the Maintenance menu The status screen will be displayed 2Touch Back Back To exam to return to the examination screen 3 bl5965 2 ...

Page 86: ...tion panel On the touch panel test screen touch the cross shaped marks and check that the marks change to circle The screen will switch each time the mark is touched Check that there are no missing dots or uneven colors in each screen 3Press the operation panel key and check that the corresponding key displayed on the screen is highlighted To end the key test touch Next 4Touch the buzzer mark and ...

Page 87: ...ral Test 2 Test the recording memory external I O 1Select General Test 2 on the Maintenance menu The General Test 2 screen will be displayed 2Prepare test cables USB memory LAN recording paper and press the Start Stop key on the operation panel The test will start and OK or NG will be displayed for each test item If the judgement is OK for all test items OK will be displayed for General bl5967 3 ...

Page 88: ...e key test screen will be displayed 2Press the operation panel key and check that the corresponding key displayed on the screen is highlighted 3Touch Back Back To exam to return to the examination screen Sound Test Test the sound operation 1Select Sound Test on the Maintenance menu The sound test screen will be displayed 2Touch the buzzer mark and check that the corresponding sound is generated 3T...

Page 89: ...n by Return to Test Touch Panel Test Test the touch panel operation 1Select Touch Panel Test on the Maintenance menu The screen to test the touch panel will be displayed 2Touch the cross shaped marks and check that the marks change to circle 3Touch End Back To exam to return to the examination screen Thermal Printing Test Test the thermal printing operation 1Select Thermal Printing Test on the Mai...

Page 90: ...he Maintenance menu I O Test menu will be displayed 2Connect the LAN cable to the LAN connector and connect to the PC using a HUB When IP address window is displayed by touching LAN enter the IP address of the electrocardiograph 3Touch LAN to start the test and check that OK is displayed 4Set the USB memory to all the USB ports 5Touch USB1 USB2 USB3 to start the test and check that OK is displayed...

Page 91: ... 0 maximum brightness is 5 Adjust to the appropriate brightness 3Touch Back Back To exam to return to the examination screen Self Diagnosis Manufacturer Maintenance There are following five items on the manufacturer maintenance menu Manufacturer Maintenance Menu 1Touch the Menu Maintenance keys 2Touch Manufacturer Maintenance and enter the password Enter the password 9001 on the following window A...

Page 92: ...ct an item AMP Status Check the AMP status On the manufacturer maintenance menu select AMP Status Adjust Perforations Adjust the recording paper perforation position On the manufacturer maintenance menu select Adjust perforations Touch the right and left arrows to adjust the perforation position bl5977 bl5978 ...

Page 93: ...s setting is not necessary as it is factory configured Adjust Touch Panel Touch the center part of displayed on the screen Screen Capture The hard copy function can be enabled disabled When enabled the displayed screen can be saved on the USB memory in png format by pressing the RESET key on the operation panel bl5979 bl5980 bl5981 ...

Page 94: ...e that OK is displayed on the status display area of the maintenance menu Tool Phillips Screwdriver 2 1Remove the lower case block Refer to the assembly diagram General Assembly Diagram P5 9 2Remove the lithium battery located at the position shown in the following picture 3As shown in the following picture hold one side and hook the edge with a finger to remove it bl5982 ...

Page 95: ...losion may occur Do not disassemble or remodel the battery If the battery breaks and the acid leaks onto the skin or clothing wash it off with water immediately If the acid gets into the eyes rinse with clean water and consult a doctor immediately Do not use the battery with any other equipment Otherwise acid leakage overheating or explosion may occur Do not short circuit the terminal Otherwise ac...

Page 96: ...hen remove the battery cover 2Take out the battery from the main unit and disconnect the battery connector from the main unit 3Connect the new battery connector to the main unit and then insert the new battery into the main unit 4Place the battery cover back in its original position and tighten the screws NOTE Pay attention to the connector orientation Place the convex side of the battery facing d...

Page 97: ...y from the equipment and store it Every three months install the battery in the equipment and fully charge it If left for a long period of time the battery may self discharge to the point where it can no longer be used Avoid storing the battery in a place where the temperature is lower than 0 C or higher than 35 C Replacement of Display Unit Backlight The display unit backlight is a component of L...

Page 98: ... adjustment will automatically end Motor Replacement When replacing the motor it is necessary to remove the recorder block After the replacement make sure to adjust the meshing of gear Tool Phillips Screwdriver 2 E Ring Plier 1Remove the recorder block Refer to General Assembly Diagram General Assembly Diagram P5 9 2Remove the motor Remove the motor from the recorder block Remove the E ring gear w...

Page 99: ...ing section Recorder Block 1 Recorder Block 1 3 P5 3 Recorder Block 2 Recorder Block 2 3 P5 4 Recorder Block 3 Recorder Block 3 3 P5 5 3Adjust the thermal recorder Refer to Adjusting the Thermal Recorder Adjusting the Thermal Recorder P8 17 Adjusting the Thermal Recorder Adjust the contact between the print head and recording paper of the thermal recorder After replacing the motor and thermal prin...

Page 100: ...st menu select the printing pattern and speed for test printing 1 Touch Print Head Test to test the print density 2 Touch Rectangular Pattern and verify that the rising line is not faded and the phase shift is within 0 5 mm 6Tighten the screws loosened in step 3 4 7Touch Rectangular Pattern and verify that the phase shift is within 0 5 mm If the phase shift exceeds 0 5 mm repeat steps 3 to 6 ...

Page 101: ...tc hot water volatile solvent and chemicals thinner benzine benzol and synthetic detergent for home and furniture or sharp edged tools Cleaning the Thermal Print Head Printing paper dust adhering to the thermal print head lowers the print quality If printed ECG data or characters begin to fade or become unclear clean the thermal array head Use a cotton swab moistened with alcohol to wipe them off ...

Page 102: ...le and connection cables Wipe gently with neutral detergent or 70 isopropyl alcohol for cleaning Do not use organic solvents such as thinner or toluene Clip electrodes Wipe gently with neutral detergent or alcohol for cleaning Do not use organic solvents such as thinner or toluene bl5992 ...

Page 103: ... Specification of this Equipment 9 6 Earth Leakage Current 9 6 Touch Current 9 7 Patient Leakage Current From Patient Connection to Ground 9 7 Patient Leakage Current When external voltage is applied to SIP SOP 9 7 Patient Leakage Current When external voltage is applied to patient connection of Type F Applied Part 9 8 Patient Auxiliary Current 9 8 Replacement of the Accessories 9 9 Replacement Pe...

Page 104: ...Chapter 9 Maintenance and Inspection Contents ...

Page 105: ...eck List P10 2 the overall judgment will be Fail Repair the equipment so that it passes all the check items Use the equipment only if the judgments for all the items are OK Daily Check Procedure Appearance Visually check the following points according to the description of the table below Item Inspection Item Procedure Criteria Main Unit 1 Enclosure Verify that there is no scratch crack deformatio...

Page 106: ...tion without abnormal noise Accessories 1 Power cable Lead cable Check whether the power cable and the lead cable can be connected to or disconnected from the main unit smoothly The power cable and the lead cable should be connected to or disconnected from the main unit smoothly 2 Clip electrode chest electrode Check the connection of the lead cables The cables should be connected properly Item In...

Page 107: ...o scratch or damage 2 Clip electrode chest electrode Check for dirt rust scratch and damage Should be free of dirt rust scratch or damage 3 Recording paper Check the condition of loading of the recording paper The recording paper should be loaded properly 4 Operation Manual Verify that the operation manual is kept in the specified storage location It must be kept in the specified storage location ...

Page 108: ...s 0 39in Within 3 Feeding rate 0 49in s 0 49in Within 3 Feeding rate 0 98in s 0 98in Within 3 Feeding rate 50 mm s 50 mm Within 3 3 LCD test Touch LCD Test on the maintenance menu screen All dots should appear The colors must be correct 4 Key test 1 Touch Key Test on the maintenance menu screen 2 Touch each key The display corresponding to the pressed key must be highlighted 4 Touch panel test 1 T...

Page 109: ...Power cable Perform continuity test using a tester Perform a continuity test using a tester and check that the equipment is conducting 1 Earth Leakage Current Leakage current that runs to the protective earth conductor 2 Touch Current Leakage current that runs through the ground from the enclosure of the device 3 Patient Leakage Current From patient connection to earth Leakage current that runs th...

Page 110: ...ble value Leakage Current Unit mA Type B Type BF Type CF Normal Condition Single Failure Normal Condition Single Failure Normal Condition Single Failure Earth Leakage Current 5 10 5 10 5 10 Touch Current 0 1 0 5 0 1 0 5 0 1 0 5 Patient Leakage Current From patient connection to earth Direct Current 0 01 0 05 0 01 0 05 0 01 0 05 Alternating Current 0 1 0 5 0 1 0 5 0 01 0 05 Patient Leakage Current ...

Page 111: ...akage Current From Patient Connection to Ground 1 Measurement wiring diagram 2 Allowable value Patient Leakage Current When external voltage is applied to SIP SOP 1 Measurement wiring diagram Normal condition Single failure 0 1mA 0 5mA Normal condition Single failure Direct Current 0 01mA 0 05mA Alternating Current 0 01mA 0 05 mA bl5870 bl5871 bl5872 ...

Page 112: ...n of Type F Applied Part 1 Measurement wiring diagram 2 Allowable value Patient Auxiliary Current 1 Measurement wiring diagram 2 Allowable value Normal condition Single failure Direct Current 0 01mA 0 05 mA Alternating Current 0 01mA 0 05 mA Single failure 0 05 mA Normal condition Single failure Direct Current 0 01 mA 0 05 mA Alternating Current 0 01 mA 0 05 mA bl5873 bl5874 ...

Page 113: ...ead lowers the overall printout density and causes missed dots 3 Paper driver motor approx 1 000 hours of use of continuous printing A worn paper drive motor results in unstable printing due to irregular paper feed and fluctuating paper speed 4 Display unit backlight 20 000 hours A worn LCD backlight lowers the LCD brightness and may prevent the LCD from illuminating 5 Battery for the clock 6 year...

Page 114: ...9 10 Chapter 9 Maintenance and Inspection Replacement of the Accessories ...

Page 115: ...10 1 Chapter 10 Appendix Contents Chapter 10 Appendix Combination Example of Medical and Non Medical Equipments 10 1 Check List 10 2 ...

Page 116: ...Chapter 10 Appendix Contents ...

Page 117: ...cal equipments that comply with IEC 60601 1 in the patient environment The system must be as safe as non medical electrical equipments that comply with other IEC or ISO safety standards outside the patient environment IEC 60601 1 specifies that the level of safety offered by non medical electrical equipments used outside the patient environment is acceptable if it conforms to the technical standar...

Page 118: ...G 4 Operation Manual Check that it is stored in specified location OK NG Mechanical Check Main Unit 1 Key Check that the key operation is smooth OK NG 2 Printer Check that the operation is smooth and that abnormal sound is not heard OK NG Accessories 1 Power cable lead cables nip lead Check for smooth operation without looseness OK NG 2 when used Clip electrode chest electrode Check that no proble...

Page 119: ... NG 3 Printing Paper Check that paper is properly loaded OK NG 4 Operation Manual Check that it is stored in specified location OK NG Mechanical Check Main Unit 1 Key Check that the key operation is smooth OK NG 2 Printer Check that the operation is smooth and that abnormal sound is not heard OK NG Accessories 1 Power cable lead cables nip lead Check for smooth operation without looseness OK NG 2 ...

Page 120: ... Sound Test Check that the pressed key is displayed the LED lights and buzzer sounds OK NG Item Inspection Item Procedure Measurement Criteria Judgment Remarks Repair required Electrical Safety 1 Earth Leakage Current Normal Condition 5 mA and below mA OK NG Single Failure Condition 10 mA and below mA OK NG 2 Touch Current Normal Condition 0 1 mA and below mA OK NG Single Failure Condition 0 5 mA ...

Page 121: ... mA and below mA OK NG 6 Patient Auxiliary Current Direct Current Normal Condition 0 01 mA and below mA OK NG Single Failure Condition 0 05 mA and below mA OK NG Alternating Current Normal Condition 0 01 mA and below mA OK NG Single Failure Condition 0 05 mA and below mA OK NG Item Inspection Item Procedure Measurement Criteria Judgment Remarks Repair required Item Inspection Item Procedure Measur...

Page 122: ...10 6 Chapter 10 Appendix Check List ...

Page 123: ...The company and product names used in this manual are trademarks or registered trademarks of respective companies ...

Page 124: ...3 39 4 Hongo Bunkyo ku Tokyo Japan Tel 81 3 5684 1455 Fax 81 3 3814 1222 http www fukuda com 4R0101440 201706 ...

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