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CAUTION

FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON
THE ORDER OF A PHYSICIAN.

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.

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

CAUTION:

•

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 due to

improvement in the equipment.

No part of this document may be copied or transmitted in any form without the prior written
permission of Fukuda Denshi Co., Ltd.

Printed in Japan

Содержание HBX-800

Страница 1: ...BISx I F Unit HBX 800 Service Manual z Before setting up maintenance please read this Service Manual thoroughly z After reading keep this manual for future reference ...

Страница 2: ...or 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 due to improvement...

Страница 3: ...Revision History Model Name HBX 800 Service Manual Edition Revised Items Reason of the Revision Date 1 New Edition 2014 02 ...

Страница 4: ...Blank Page ...

Страница 5: ...equipment which the HBX 800 is connected to and the BISx Module to measure the BIS SQI SR and EMG Connecting the HBX 800 BISx I F Unit and HS 8312N HS 8312M Super Unit For details on BIS SQI SR and EMG measurement refer to the operation manuals of the DS 8500 System Patient Monitor and HS 8000 series Super Unit 1 ...

Страница 6: ...l 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 Requirements for Safety Collateral standard Safety Requirements for Medical Electrical...

Страница 7: ...c Trend Suppression Ratio SR 0 100 Spectral Edge Frequency SEF 0 5 30 0Hz Total Power TOTPOW 40 100dB Wave Scale 25uV 50uV 100uV 250uV Filter ON 2 0 70Hz Notch filter 50 60Hz Filter OFF 0 25 100Hz Notch filter OFF Alarm Range BIS Upper alarm 2 99 OFF Lower alarm 1 98 OFF Adjustment 1step BIS Measurement BIS measurement specification depends on the specification of the BISx connected Input Impedanc...

Страница 8: ...e HS 8312N HS 8312M WARNING Do not connect a unit or cable not authorized by Fukuda Denshi to any I O connector If done so by mistake this equipment cannot deliver its maximum performance and the connected equipments may be damaged resulting in a safety hazard CAUTION If the indicator does not light or lights red when connected to the patient monitor disconnect it and cease using the equipment Con...

Страница 9: ... 1 12V 12V Power Supply from HS 8000 2 12V 12V Power Supply from HS 8000 3 GND_P GND 4 GND_P GND 5 5V 5V Power Supply from HS 8000 6 5V 5V Power Supply from HS 8000 7 GND GND 8 GND GND 9 HOST_TxD Serial Data Input from HS 8000 RS 232C 10 HOST_RxD Serial Data Output to HS 8000 RS 232C 11 _RESET Reserved 5V TTL Negative Logic 12 POD_ON Unit I F Detection Signal 13 POD_DETECT Unit I F Information Sig...

Страница 10: ... If the indicator lights red it could not supply 5V to BISx PCB 7604 READY LED board is installed in front of the HBX 800 Internal Connector on the PCB 7605 POD Cable Connector CN1 DF11C 14DP 2V No Signal Type Description Note 1 12V 12V Power Supply from HS 8000 2 12V 12V Power Supply from HS 8000 3 GND_P GND 4 GND_P GND 5 5V 5V Power Supply from HS 8000 6 5V 5V Power Supply from HS 8000 7 GND GND...

Страница 11: ...x RS 232 11 Baud Select 0 9600 1 57600 Normal 1 12 COM Select 0 USB 1 other Normal 1 13 RESET Reset Signal Output 5V TTL Positive Logic 14 BIS_Detect Driving power supply of BISx LED Interface Connector CN3 FI S10P HFE No Signal Type Description Note 1 VDD_GREEN1 Power Supply for Green LED1 2 VDD_RED1 Power Supply for Red LED1 3 LED_GREEN2 Power Supply for Green LED2 4 LED_RED2 Power Supply for Re...

Страница 12: ...1M0105820 BIS IF unit LED cable Other Spare Parts Item Code Item Name Note 6C0128890 Rear bracket Same as HPD 810 6C0114470 Rear hole Cover Same as HPD 810 6C0128880 Rear Cover Same as HPD 810 6C0117230 LED lens Same as HPD 810 9H0107810 Board Plate SU 9H0107800 HBX front cover SU EXP 6C0136260 HBX front panel EXP 9H0106170 Case L SU Same as HPD 810 6C0128870 Case R Same as HPD 810 Labels Item Cod...

Страница 13: ...ont cover SU EXP 1 5 9H0107810 310 17481 Board plate SU 1 6 6C0117230 310 14363 LED lens 1 7 6C0128880 310 16260 Rear cover 1 8 6C0114470 310 13940 Rear hole cover 1 9 6C0128890 310 16261 Rear bracket 1 10 1M0105820 310 17490 BIS IF unit LED cable 1 11 1M0105810 310 17491 BIS IF unit Input connector cable 1 12 1M010503A 310 16753 AUX inner cable for HPD 810 Same as HPD 810 1 13 9F0106870 BIS IF bo...

Страница 14: ...ackage to ensure correct sensor placement Cause 3 Patient interface cable is defective Solution Replace the patient interface cable Cause 4 BISx is defective Solution Replace the BISx BIS Sensor Disconnected is displayed Cause 1 Sensor is disconnected Solution Connect the sensor Cause 2 Poor or contaminated connection between the sensor and patient interface cable Solution Connect clean connection...

Страница 15: ...mpt to determine and eliminate cause Cause 3 Patient interface cable is defective Solution Make sure that sensor check passes If not replace the patient interface cable Cause 4 BISx is defective Solution Replace the BISx BIS SQI 15 is displayed Situation The signal quality is too low to accurately calculate a BIS value The BIS value and other trend variables that are adversely affected by artifact...

Страница 16: ...se Sensor has been connected and disconnected too many times Solution Replace the sensor Replace BIS Sensor Invalid Sensor is displayed Cause Sensor is invalid Solution Replace the sensor Sensor Usage 24hrs is displayed Cause Sensor was attached to the system for more than 24 hours Solution Replace the sensor BISx Failure is displayed Cause 1 Poor connection between the BISx and monitor Solution F...

Страница 17: ...S 8500 service manual The HBX 800 test menu is operated from the display of the DS 8500 system main unit 1 Press the Menu Maintenance Test Menu keys and enter password 11111111 NOTE The Test Menu screen may differ depending on the software version 2 On the Test Menu screen press the Maintenance CO2 HBX key The serial communication status with BISx will be displayed 13 ...

Страница 18: ...ries 13F0 will be displayed for AUX EEPROM Loop Back START STOP To perform loop back test press this key Checking the Power Supply Indicator of HBX 800 When the power is turned ON and BISx is not connected it will light in orange When the BISx is connected it will light in green If HBX 800 is defective it will light in red or turns off In such case HBX 800 needs to be repaired 14 ...

Страница 19: ...d to investigate and possibly replace the PIC or BISx Expected Impedance Values Sensor Simulator Values Electrode Typical Range 1 5K Ohms 4 6 K Ohms 2 10K Ohms 8 17 K Ohms 3 4K Ohms 3 5 K Ohms 4 3K Ohms 2 4 K Ohms Checking Leakage Current Safety Testing Leakage Current Leakage Current testing should be performed by a qualified Biomedical Engineering Technician or authorized personnel only The syst...

Страница 20: ...using 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 furniture or sharp edged tools The surface resin coating may be damaged resulting in discoloration scratches and other problems Cleaning and Disinfecting the BISx Module Clean any spillage of blood or solutions ...

Страница 21: ...Printed in Japan 4R0101000 201402 3 39 4 Hongo Bunkyo ku Tokyo Japan Tel 81 3 5684 1455 Fax 81 3 3814 1222 http www fukuda com ...

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