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Precautions for Safe Operation of Medical Electrical Equipment 

C A U T I O N  

Read the following precautions thoroughly to correctly operate the 
device. 

z

  Users should have a thorough knowledge of the operation before using 

this system. 

z

  Pay attention to the following when installing and storing the equipment.

y

  Do not install or store in an area where the equipment will be subject 

to splashing water. 

y

  Do not install or store in an area where the environmental conditions, 

such as atmospheric pressure, temperature, humidity, ventilation, 
sunlight, dust, sodium, sulfur, will adversely affect the system. 

y

  Place the equipment on a stable surface where there is no 

inclination, vibration, or shock (including during transportation). 

y

  Do not install or store in an area where there are chemical or gasses 

stored. 

y

  Verify the power frequency, voltage and allowable current (or power 

consumption). 

y

  Ensure the grounding is proper by connecting the accompanying 

power cable to the hospital grade outlet. 

z

  Before operating the equipment, verify the following items. 

y

  Check the cable connection and polarity to ensure proper operation 

of the unit. 

y

  Make sure the power system has adequate earth ground. 

y

  Ensure that all cables are firmly and safely connected. 

y

  Pay special attention when the equipment is used in conjunction with 

other equipment as it may cause erroneous judgment and danger. 

z

  During operation of the system, verify the following items. 

y

  Always observe the system and patient to ensure safe operation of 

the equipment. 

y

  If any abnormality is found on the equipment or patient, take 

appropriate measures such as ceasing operation of the equipment in 
the safest way for the patient. 

y

  Do not allow the patient to come in contact with the device. 

y

  Make sure not to touch all Signal Input/Output parts in the device 

with the patient at the same time. 

z

  After using the system, verify the following items. 

y

  When unplugging the cables, do not apply excessive force by pulling 

on the cord. Pull by the connector part of the cable. 

y

  Clean the accessories and cables, and keep them together in one 

place. 

y

  Keep the unit clean to ensure proper operation of the next use. 

z

  If the equipment is damaged and in need of repair, user should not 

attempt service. Label the unit 

OUT OF ORDER

  and contact our 

service representative. 

z

  Do not remodel the equipment. 

z

 Maintenance 

Check 

y

  Make sure to periodically check the equipment, accessories and 

cables. 

y

  Before reusing the device that has been left unused for a while, make 

sure that the device works normally and safely. 

 

 

iii 

Summary of Contents for HR-800

Page 1: ...HR 800 Recorder Module Service Manual z Before setting up maintenance please read this Service Manual thoroughly z After reading keep this manual for future reference ...

Page 2: ...is service manual verify that there is no paging disorder or missing page You are requested to kindly fill the underlined area below in this sheet and send it back to us after verification Please be noted that photocopying of this manual is strictly prohibited Also for improvement of the future service manual your comment and request will be appreciated If you have any comment or request on usabil...

Page 3: ...Revision History Model Name HR 800 Service Manual Edition Revised Items Reason of the Revision Revised Date 1 New Edition 2011 08 ...

Page 4: ...Blank Page ...

Page 5: ...pment iii Precautions about the Maintenance iv Non Explosion Proof iv Precautions about Magnetic Resonance Imaging iv Precautions about Connections to Peripheral Devices v Accessories and Optional Accessories v Precautions about the HR 800 System v Disposing of Equipment Accessories or Components vi Precautions about Transportation vi Electromagnetic Compatibility vii Precautions for Safe Operatio...

Page 6: ...s message may result in death or serious injury or complete failure of the equipment CAUTION Failure to follow this message may cause injury or failure to the equipment NOTE A note is not related to product safety but provides information about the correct use and operating procedures to prevent incorrect operation and malfunction of the equipment Graphic Symbols Refer following for the meaning of...

Page 7: ...ground y Ensure that all cables are firmly and safely connected y Pay special attention when the equipment is used in conjunction with other equipment as it may cause erroneous judgment and danger z During operation of the system verify the following items y Always observe the system and patient to ensure safe operation of the equipment y If any abnormality is found on the equipment or patient tak...

Page 8: ...rade outlet as it may result in electric shock Maintenance Modifications and Repairs Fukuda Denshi is liable for the safety reliability and performance of its equipment only if y Maintenance modifications and repairs are carried out by authorized personnel y Components are used in accordance with Fukuda Denshi operating instructions Non Explosion Proof DANGER Never operate the equipment in the pre...

Page 9: ...1 1 Collateral Standard Safety Requirements for Medical Electrical Systems Accessories and Optional Accessories WARNING Use only the cables specified by Fukuda Denshi Use of other cables may result in increase in emission or decrease in immunity Precautions about the HR 800 System DANGER When connecting to other equipments contact our service representative Danger such as electric shock may result...

Page 10: ...rasive or chemical cleaner y When sterilizing the entire room using a spray solution pay close attention not to have liquids get into the monitor or connectors y Use only neutral detergent to clean the housing Do not use chemical cloth scrub brush abrasive polishing powder hot water volatile solvent and chemicals cleanser thinner toluene benzine benzol and synthetic detergent for house and furnitu...

Page 11: ...th operator and patient should remove any static electricity before entering the room y Humidify the room z Lightning y A lightning nearby may induce excessive voltage to the equipment If any danger is suspected use the uninterruptible power supply system z High frequency noise interference from other device through the power outlet y Check where the noise is originated and remove it using filteri...

Page 12: ...viii Blank Page ...

Page 13: ...es wiring diagram Chapter 6 Spare Parts List This chapter describes electrical parts and cables inside equipment Chapter 7 Assembly Diagram This chapter describes assembly diagram Chapter 8 Software Upgrade Procedure This chapter describes Software Upgrade Chapter 9 Caution Label This chapter describes caution labels attached to this unit Chapter 10 Troubleshooting This chapter describes points to...

Page 14: ... 2 HR 800 Recorder Module Name of Parts and Their Functions 3 2 Chapter 4 Operational Description HR 800 Recorder Module 4 2 HR 800 Recorder Module Block Diagram 4 2 HR 800 Recorder Module Board Block Diagram 4 3 Circuit Explanation 4 5 Chapter 5 Wiring Diagram HR 800 Recorder Module 5 2 Wiring Diagram wiring diagram of each block 5 2 Wiring Diagram Block Diagram of the Recorder Unit 5 3 Chapter 6...

Page 15: ... Chapter 12 Periodic Check Periodic Check Daily and Periodic Check 12 2 About the Periodic Check 12 2 Daily Check 12 2 Periodic Check 12 2 Daily Check 12 3 Daily Check Procedure 12 3 Daily Check List 12 4 Periodic Check 12 5 Introduction 12 5 ...

Page 16: ...xii Blank Page ...

Page 17: ...1 1 General Description Chapter 1 HR 800 Recorder Module 1 2 HR 800 Recorder Module General Description 1 2 ...

Page 18: ... Module HR 800 is used to record waveforms numeric data and graphic trend monitored on the DS 8500 system on the recording paper With its high end thermal head up to 3 channels of waveforms can be recorded in high resolution Furthermore graphics such as trend graph and tabular trend can also be recorded The recording speed can be set to 25mm s or 50mm s ...

Page 19: ...Specification Chapter 2 HR 800 Recorder Module 2 2 HR 800 Recorder Module Specification 2 2 2 1 ...

Page 20: ...ndard CE EN 60601 1 2 Ed 3 0 2007 Medical electrical equipment Part 1 2 General requirements for basic safety and essential performance Collateral standard Electromagnetic compatibility Requirements and tests General Standard IEC 60601 1 1998 A1 1991 A2 1995 Medical Electrical Equipment Part 1 General Requirements for Safety IEC 60601 1 1 2000 Medical Electrical Equipment Part 1 1 General Requirem...

Page 21: ...mm s 50mm s individually 5 Recording Pape Width 50mm OP 050 01TDR Recording Waveforms Maximum 3 waveforms Feed Continuously feeding the recording paper to the top page Printing Density Waveform Amplitude Direction 8dot mm Feed direction of recording paper 40line mm For 25mm s 20line mm For 50mm s 2 3 ...

Page 22: ...t Summary Printing Hemodynamics calculation data Waveform Recording of ST Measurement Record of CO measurement result OCRG Record Σ Record Ventilator P V Curve Record Ventilator Measurement Detection Paper out Magazine Open paper jam Page mark Control Key or CAUTION For quality improvement specifications are subject to change without prior notice 2 4 ...

Page 23: ...Names of Parts and Their Functions Chapter 3 HR 800 Recorder Module 3 2 HR 800 Recorder Module Features 3 2 HR 800 Recorder Module Name of Parts and Their Functions 3 2 3 1 ...

Page 24: ... monitors as a module HR 800 Recorder Module Features Up to 3 channels waveforms and patient data can be recorded on the 50 mm wide recording paper Once the paper holder is open it is easy to set the recording paper HR 800 Recorder Module Name of Parts and Their Functions Front Side 1 Open Close Lever 2 Paper Holder 3 READY LED 4 Record Key Record 5 Paper Feed Key Feed 3 2 ...

Page 25: ...green When the recording paper is used up LED or will light in orange 4 Record Key RECORD While the recording is being performed LED or will light in blue Pressing the key again will stop the recording 5 Paper Feed Key FEED Even if the recording is not performed the LED or will light in blue while the key is being pressed Releasing the key turns off or and stops feeding the paper Rear Side 6 U LIN...

Page 26: ...3 4 Blank Page ...

Page 27: ...Operational Description Chapter 4 HR 800 Recorder Module 4 2 HR 800 Recorder Module Block Diagram 4 2 HR 800 Recorder Module Board Block Diagram 4 3 Circuit Explanation 4 5 4 1 ...

Page 28: ...owing is the block diagram of the hardware composition HR 800 Membrane Sheet CN1 The parts list for the HR 800 block diagram is as follows No Item Code Item Name 1 9F0101390 HR 800 IF BOARD 2 1M010211B Intermediation Cable 3 9D0105020 HR 800UNIT 4 6C0118260 HR 800 Membrane Sheet 2 1 3 CN1 4 HR 800 IF BOARD PCB 7332A HR 800CPU BOARD PCB 7333B HR 800UNIT CN2 4 2 ...

Page 29: ...G_ON_PLD 基板側コネクタ DF20F 20DP 1V 56 I Fコネクタ 高密度D sub26ピン オス C0575 26MIABGWR I Fコネクタ 高密度D sub26ピン メス C0575 26FIANGWR メンブレンSW用コネクタ 08 6262 009 340 829 CS3 RD WRL A16 0 D7 0 8MHz SG 8002CE 8 0000M PCMB EXTAL LAT IRQ0 I O REC_EXE 7 RESET RNA52A10MMEL E RES RESET1 RESET2 CNT2 RESET2 CNT2 基板側コネクタ DF20F 20DP 1H 50 DC 3 3V 2 DC 3 3V WDT ΦI 64MHz ΦP 16MHz DC 18V ホットスワップ LT1641 2 ブザー PS1440 P02BT I O TH2 2 GN...

Page 30: ...gital GND 8 V Digital GND 9 V Digital GND 10 TX1 Serial Transmission Data Output 1 RS422Output 11 RX1 Serial Reception Data Input 1 RS422 Input 12 TX2 Serial Transmission Data Output 2 RS422Output 13 RX2 Serial Reception Data Input 2 RS422 Input 14 V 18V 15 V 18V 16 V Digital GND 17 V Digital GND 18 V Digital GND 19 RESET1 Reset Signal 1 TTL Low Level Reset 20 RESET2 Reset Signal 2 TTL Low Level R...

Page 31: ...us Bφ 32 MHz Peripheral Pφ 16 MHz System Clock Utilizes 8MHz crystal oscillator output as CPU system clock Buzzer Activates the buzzer with 4KHz frequency clock PLD The motor activation and strobe output timing is controlled inside the PLD Speed 25mm s 50mm s Strobe Width Adjustable Range 0 to 1000μs Resolution 50μs Temperature Detection by the Software Overheat OVH will be detected when 80 is exc...

Page 32: ...vercurrent Monitor Monitors the current of 1 5A or above by the comparator and if it is detected for 3ms or more stops the 24V supply to the printhead and 18V supply to the 24V output DC DC converter 4 6 ...

Page 33: ... O MT A 14 GND 29 O MT B 15 GND 30 O MT B Membrane Switch Connector HR8CPU Board CN2 Connector 08 6262 009 340 829 Kyocera Elco Pin No I O Item Pin No I O Item 1 3 3V 6 I LED_FEED 2 3 3V 7 I SW_REC 3 I LED_PWR_G 8 I SW_FEED 4 I LED_PWR_R 9 COMMON GND 5 I LED_REC Board Connector HR8CPU Board CN1 Connector DF20F 20DP 1V 56 Hirose Pin No I O Item Pin No I O Item 1 24V 11 GND 2 24V 12 GND 3 24V 13 GND...

Page 34: ... Connector XG4C 1031 Omron Pin No I O Item Pin No I O Item 1 I TCK 6 NC 2 GND 7 NC 3 O TDO 8 NC 4 3 3V 9 I TDI 5 I TMS 10 GND JTAG Debug Connector HR8CPU Board Connector XG4C 1431 Omron Pin No I O Item Pin No I O Item 1 I TCK 8 O VCC 2 NC 9 I TMS 3 I TRST 10 NC 4 I ASEMD0 11 I TDI 5 O TDO 12 GND 6 GND 13 O RESET 7 IO ASEBRKAK ASEBRK 14 GND Serial Connector HR8CPU Board Connector DF11 8DP 2DSA 08 H...

Page 35: ...Wiring Diagram Chapter 5 HR 800 Recorder Module 5 2 Wiring Diagram wiring diagram of each block 5 2 Wiring Diagram Block Diagram of the Recorder Unit 5 3 5 1 ...

Page 36: ...800 Recorder Module wiring diagram of each block Wiring Diagram wiring diagram of each block MENBRANE SWITCH CSK ET 0120 CN1 CN1 HR 800 IF BOARD PCB 7332A HR 800 CPU BOARD PCB 7333B CN2 CN3 1 CN3 Thermal Printer LTPD247B Recorder Unit Recorder Module 5 2 ...

Page 37: ...Wiring Diagram Block Diagram of the Recorder Unit 5 3 ...

Page 38: ...re board or contact your local Fukuda Denshi factory for service Parts may be damaged when reparing detaching connectors on the board as they are very small and pin pitch is very narrow Connection Cable List No Cable Note Intermediation cable 1M010211B 5 4 ...

Page 39: ...Spare Parts List Chapter 6 The spare parts in this chapter mainly include electrical parts and cables inside equipment HR 800 Spare Parts 6 2 6 1 ...

Page 40: ... Electrical Parts are as follows Item Code Item Name Model Type Note 6C0118260 HR 800 membrane sheet 9D0105020 HR 800UNIT The spare parts cables of the HR 800 are as follows Item Code Item Name Note 1M010211B Intermediation cable 6 2 ...

Page 41: ...7 1 Assembly Diagram Chapter 7 HR 800 Assembly1 HR 800 01A 7 2 HR 800 Assembly2 HR 800 02A 7 3 ...

Page 42: ...7 2 HR 800 Assembly1 HR 800 01A ...

Page 43: ...7 3 HR 800 Assembly2 HR 800 02A ...

Page 44: ...7 4 Blank Page ...

Page 45: ...8 1 Software Upgrade Procedure Chapter 8 Software Upgrade Procedure 8 2 Preparation 8 2 Upgrade 8 2 Upgrade check 8 2 ...

Page 46: ...ot on the Main Unit Upgrade Press in the following keys Menu Maintenance Module Install to display the Module Install screen Check the current HR 800 version Check the software version inside the CF Card To display the version of install file press the HR 800 key Check the version start the installation by pressing the Start Install key if there is no problem When the Install completed message app...

Page 47: ...Caution Label Chapter 9 Caution Label 9 2 HR 800 9 2 9 1 ...

Page 48: ...Caution Label HR 800 HR 800 9 2 ...

Page 49: ...Troubleshooting Chapter 10 HR 800 Recorder Module 10 2 Troubleshooting 10 2 Troubleshooting for HR 800 Main Unit 10 2 Troubleshooting for the DS 8500system Technical Alarm Sound 10 3 10 1 ...

Page 50: ...nearest service representative Situation Pressing the Record key or Paper Feed Key does not feed the recording paper Cause The recording paper is jammed inside the paper holder Solution Open the paper holder properly set the recording paper Although the recording paper is fed printing is not performed Situation Pressing the Record Key feeds the recording paper though printing is not performed Caus...

Page 51: ...olution 2 Check the U LINK cable connection The Check Built in Recorder message is displayed and recording cannot be conducted Cause 1 Thermal Head temperature exceeds 70 Solution 1 Resume printing under the condition where the Thermal Head temperature is below 60 Check the Recorder Adjust screen for Thermal Head temperature Cause 2 The HR 800 detects a hardware failure Solution 2 If the situation...

Page 52: ...10 4 Blank Page ...

Page 53: ...ce Chapter 11 Test Menu 11 2 How to Display the Test Menu 11 2 Test Menu Description 11 2 Storage of the Equipment and Recording Paper 11 9 Storage 11 9 Cleaning 11 10 Cleaning the Housing and cables 11 10 11 1 ...

Page 54: ... Menu To Display the Maintenance Screen Menu Maintenance Test Menu Password For the password request enter 11111111 NOTE The Test Menu screen may differ according to the software version Test Menu Description Printer Adjust Adjusts the HR 800 Recorder Module Printer Adjust key is located on the third row in the middle Print density adjustment feed speed software version serial communication status...

Page 55: ...s opened Recording paper Status Set Nil Paper is present Paper is out Thermal Head Temperature The temperature display is 1 resolution Status Normal Abnormal Thermal Head temperature is below 70 When the thermal head temperature is 70 or above it will be detected as abnormal Once this condition is detected printing and feeding will stop until the temperature drops to 60 or below 11 3 ...

Page 56: ...re If the printing is too light Press the Dark key The maximum adjustable value offset is 7 Adjust to the value which is not too dark and can be cleary read If the printing is too dark Press the Light key The minimum adjustable value offset is 7 Adjust to the value which is not too light and can be cleary read 11 4 ...

Page 57: ... the paper cassette 2 Check the print result according to the following criteria Print Speed Criteria 25mm s By adjusting the scale to 10cm the printing should be within 9 7cm to 10 3cm Print Speed Criteria 50mm s By adjusting the scale to 10cm the printing should be within 9 7cm to 10 3cm Note 25mm speed test and 50mm speed test will be automatically performed by just pressing the Test Print A ke...

Page 58: ...han 70cm and is properly installed in the paper cassette 2 Check the print result according to the following criteria Printhead Voltage Criteria Printhead Voltage There should be no patches inside the blocks Printhead Contact Criteria Vertical Lines All vertical lines should be printed evenly 11 6 ...

Page 59: ...should be clearly visible Note If the print is too dark or too light adjust the printing using the keys of Thermal Head Strobe Duration Adjustment If the printing is suitable this adjustment is not necessary After the adjustment press the Test Print B key again and check if the printing is properly performed 11 7 ...

Page 60: ...ON When the communication is interrupted the initial communication will start As this will be performed at power ON a value above 1 will be displayed NAK Count Displays the integrated value of NAK reception count since the power of the DS 8500 was turned ON When an error occurs on HR 800 reception data NAK reception count will increase CRC Error Count Displays the integrated value of CRC error cou...

Page 61: ...e equipment will not be adversely affected by atmospheric pressure temperature humidity ventilation sunlight dust or atmosphere containing salt or sulfur y Place the equipment on a stable surface where there is no inclination vibration or shock including during transportation y The following environmental conditions should be observed when storing the equipment Storage Temperature 10 to 60 C Stora...

Page 62: ...ctors z Do not use organic solvents thinner toluene and benzene to avoid damaging the resin case z Do not polish the housing with abrasive or chemical cleaner z When sterilizing the entire room using a spray solution pay close attention not to have liquids get into the equipment or connectors z Use only neutral detergent to clean the housing Do not use chemical cloth scrub brush abrasive polishing...

Page 63: ... 12 Periodic Check Daily and Periodic Check 12 2 About the Periodic Check 12 2 Daily Check 12 2 Periodic Check 12 2 Daily Check 12 3 Daily Check Procedure 12 3 Daily Check List 12 4 Periodic Check 12 5 Introduction 12 5 12 1 ...

Page 64: ...nd high performance a Daily Check and Periodic Check must be performed Please be aware that Fukuda Denshi is not liable of any accidents arising from lack of maintenance check CAUTION Do not open the housing Avoid alcohol or other liquids from getting into the equipment Daily Check Perform daily check using a Daily Check List Periodic Check Periodic inspection of medical electronic equipment is ma...

Page 65: ...uipment is installed in a place susceptible to adverse environment The environmental condition e g temperature humidity of the installed place should be as specified The equipment should not be subjected to splashing water 03 Cables Check that neither damage nor broken wire is found in all cables Neither damage nor broken wire should be found 04 Periodic Check Check the date of the previous period...

Page 66: ...s specified The unit should not be subjected to splashing water OK NG Pressing the or key should light the Recorder Busy indicator and start the printing Pressing the key again should stop the printing OK NG Pressing the or key should light the Feed indicator and starts the feeding OK NG Functions Turn ON the power of the monitor and check that it functions properly Install a small amount of paper...

Page 67: ...tails of the electrical safety check procedure refer to IEC 60601 1 EN60601 1 Periodic Check List No Item Details Criteria Judgment Note Repair 1 Operation Manual Check visually and by cable conduction test OK NG Accessories 2 Recording Paper Check storage condition of the stock OK NG 1 Exterior scratch crack deformation No damage should be found OK NG 2 Loose label panel stain Indication should b...

Page 68: ...12 6 Blank Page ...

Page 69: ...ON This device for sale by or on the order of a physician The company and product names used in this manual are trademarks or registered trademarks 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 du...

Page 70: ...Printed in Japan 4R0100670 201108 39 4 Hongo 3 chome Bunkyo ku Tokyo Japan Phone 81 3 3815 2121 Fax 81 3 3814 1222 ...

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