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Check Item

Check Procedure

Criteria

13. Electrical Safety

01 Patient

Leakage

Current-I (NC)

Measure the patient leakage current-I
in normal condition using a leak
measurement safety tester. Connect
with the DSC-8500 and measure.

According to test procedure of IEC 60601-1 19.

【

AC/DC

】

Patient Leakage Current-I

(NC)

≤

0.01mA

02 Patient

Leakage

Current-I (SFC)

Measure the patient leakage current-I
in single failure condition using a leak
measurement safety tester. Connect
with the DSC-8500 and measure.

According to test procedure of IEC 60601-1 19.

【

AC/DC

】

Patient Leakage Current-I

(SFC)

≤

0.05mA

03 Patient

Leakage

Current-III (SFC)

Measure the patient leakage current-III
in single failure condition using a leak
measurement safety tester. Connect
with the DSC-8500 and measure.

According to test procedure of IEC 60601-1 19.

Patient Leakage Current-III

(SFC)

≤

0.05mA

04 Patient Current (NC)

Measure normal patient current (NC)
using a leak measurement safety
tester. Connect with the DSC-8500 and
measure.

According to test procedure of IEC 60601-1 19.

Patient Current (NC)

≤

0.01mA

05 Patient Current (SFC) Measure single failure patient current

(SFC) using a leak measurement
safety tester. Connect with the
DSC-8500 and measure.

According to test procedure of IEC 60601-1 19.

Patient Current (SFC)

≤

0.05mA

No Check Item

Check Procedure

Criteria

13. Electrical Safety (*)

Perform the following check item as appropriate. Check these items when you have
disassembled the equipment to check or replace the boards inside the unit or the unit.

06 Withstand

Voltage

Test (A-a2)

Apply AC3000V for 1 minute between
primary power source and exterior
without protective ground (A-a2).
Connect with the DSC-98550 and
measure.

According to test procedure of IEC 60601-1 20.

Should resist the applied

voltage.

07 Withstand

Voltage

Test (B-a)

Apply AC3000V for 1 minute between
primary power source and applied part
(B-a).

According to test procedure of IEC 60601-1 20.

Should resist the applied

voltage.

08 Withstand

Voltage

Test (B-d)

Apply AC1500V for 1 minute between
the exterior and applied part (B-d).

According to test procedure of IEC 60601-1 20.

Should resist the applied

voltage.

－

Содержание HS-8000 Series

Страница 1: ...Super Unit HS 8000 Series Service Manual z Before setting up maintenance please read this Service Manual thoroughly z After reading keep this manual for future use ...

Страница 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...

Страница 3: ...Revision History Model Name HS 8000 Series Service Manual Edition Revised Items Reason of the Revision Revised Date 1 New Edition 2011 8 ...

Страница 4: ...Blank Page ...

Страница 5: ...ystem v ECG Recording by the Mason Likar System v Electrode Placement v Electrosurgery Safety vi Precautions about Magnetic Resonance Imaging vi Precautions about Connections to Peripheral Devicesvii Accessories and Optional Accessories vii Precautions about the HS 8000 System viii Precautions for Use of SpO2 Sensor xi Precautions about Masimo SpO2 measurement unit HS 8312M xii Precautions for Use...

Страница 6: ...nformation about the correct use and operating procedures to prevent incorrect operation and malfunction of the equipment Graphic Symbols Refer to the following for the meaning of the symbols indicated on the equipment Symbol used in the Unit Symbol Description Caution refer to accompanying documents Indicates the need to refer to related accompanying documents before operation Electrostatic Sensi...

Страница 7: ...nt and danger y Ensure all patient connections are proper and secure 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 t...

Страница 8: ...pairs are carried out by authorized personnel y Components are used in accordance with Fukuda Denshi operating instructions Precautions about the Pacemaker WARNING z Minute ventilation rate adaptive implantable pacemakers can occasionally interact with the bedside monitor including this unit and diagnostic equipment causing the pacemakers to pace at their maximum programmed rate The cardiac monito...

Страница 9: ...e disconnected cable may result in electrical shock by the discharged energy z When defibrillating do not touch the patient and the metal part of the device or cables Electric shock may result by the discharged energy Precautions about the Mason Likar System ECG Recording by the Mason Likar System CAUTION The 12 lead ECG recorded with the torso placement of the limb leads Mason Likar 12 lead syste...

Страница 10: ...ctrode Placement The amount of interference is considerably different depending on the electrode position and surgery site Place the ECG electrodes as far away as possible from the surgery site Do not place electrodes in the path between the surgery site and the ground plate If the electrodes are placed in this path the amount of interference will be quite large Position and electrodes as close as...

Страница 11: ...or on this unit analog output connector is insulated from the circuit applied to the patient z The circuit connected to this unit on the peripheral side is not necessarily insulated Therefore since touching the peripheral directly may result in electric shock to the patient always position the peripheral away from the patient When connecting peripheral devices to this unit it is the user s respons...

Страница 12: ...ry z For the following case accurate measurement may not be possible y Patient with excessive abnormal hemoglobin COHb MetHb y Patient with the pigment injected to the blood y Patient receiving CPR treatment y When a sensor is applied to a limb with NIBP cuff arterial catheter or intracatheter y When measuring at site with venous pulse y Patient with body motion y Patient with small pulse z Before...

Страница 13: ...n a fusion beat QRS detection will be suspended and the heart rate will be reduced y If a pacemaker pulse is continuously detected due to AC frequency interference QRS detection will be suspended and the heart rate will be reduced z Arrhythmia Analysis y For proper arrhythmia detection and ECG monitoring verify proper electrode placement lead selection and ECG waveform size If necessary turn ON th...

Страница 14: ... NIBP Monitoring y Select the appropriate cuff size which best fits the arm circumference If the cuff size is inappropriate it may cause measurement error y Do not use a cuff which is worn out The cuff may burst during inflation y Make surethat the cuff hose connection is secure If there is any air leakage correct NIBP measurement cannot be performed y Correct NIBP measurement cannot be performed ...

Страница 15: ... relay cables frequently so stains can be removed easily y To prevent injury it is recommended to wear gloves when cleaning the equipment y Do not allow liquids or cleaning solution to enter the equipment or connectors y Do not use organic solvents thinner toluene or benzene to avoid damaging the resin case y Do not polish the housing with abrasive or chemical cleaner y When sterilizing the entire...

Страница 16: ...cification for Environmental Conditions during transportation Precautions about RTC or Data Backup CAUTION z This unit is equipped with a built in clock and its time links with the time of the main unit Even if the power of this equipment is turned OFF a lithium battery updates backup of the time Every time the main unit is turned ON the time of the main unit is set up z Even if the power is turne...

Страница 17: ...d function of this unit Chapter 5 Spare Parts List This chapter describes electrical parts and cables inside equipment Chapter 6 Assembly Diagram This chapter describes assembly diagram Chapter 7 Software Upgrade Procedure This chapter describes software upgrade of this unit Chapter 8 Troubleshooting This chapter describes points to be checked and procedure toward trouble symptoms Chapter 9 Mainte...

Страница 18: ...Super Unit HS 8000 4 2 HS 8000 Main Unit Configuration Diagram 4 2 Main CPU block diagram 4 5 CPU Board Circuit Explanation 4 6 ECG Board Block Diagram 4 11 Analog Board Circuit Explanation 4 12 Multi AMP Board Block Diagram 4 16 Multi AMP Board Circuit Explanation 4 17 Mother Board Block Diagram 4 20 Mother Board Circuit Explanation 4 21 NIBP Module NIBP 801 4 25 NIBP 801 Module Configuration Dia...

Страница 19: ...eriodic Check Maintenance Check Daily and Periodic Check 10 2 About Maintenance Check 10 2 Daily Check 10 2 Periodic Check 10 2 Periodic Replacement Period for Each Part 10 2 Daily Check 10 3 Daily Check Procedure 10 3 Daily Check List 10 4 Periodic Check 10 5 Introduction 10 5 Service tools Measurement Device 10 5 Periodic Check Item 10 6 Periodic Check Procedure 10 6 Periodic Check List 10 12 ...

Страница 20: ...xvi Blank Page ...

Страница 21: ...General Description Chapter 1 General Description 1 2 Features 1 3 1 1 ...

Страница 22: ...odel available depending on the number of ECG electrodes 5 or 10 And also the arterial oxygen saturation SpO2 models with built in SpO2 modules manufactured by Nellcor TM or MASIMO are available Also the HS 8000 series has Multiconnector and can selects and measures the parameters such as TEMP BP and CO Lineup of Super Unit Model Type Fixed SpO2 module Multiparameter Measuring Items CO2 Measuremen...

Страница 23: ...n y The equipment has keys for alarm silence BP zero balance and NIBP start stop y The equipment also has an analog output connector to output analog signal 1ch ECG waveform 2ch BP waveform and QRS SYNC signal y By connecting the HPD 800 Gas Unit I F or the HCP 800 CO2 Gas Unit both external option to an AUX connector CO2 measurement is possible 1 3 ...

Страница 24: ...1 4 Blank Page ...

Страница 25: ...Specification Chapter 2 Specification Performance 2 2 Specification 2 2 Performance 2 4 2 1 ...

Страница 26: ...s 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 Systems EMC ...

Страница 27: ...etics Operation Mode Continuously operation equipment Power Requirements Voltage DC 12V Usable Life 6 years According to self certification Refer to Chapter 9 Maintenance for the usable life of periodic replacement parts 2 3 ...

Страница 28: ...n 1 4 2 5mm mV 1 2 5mm mV 1 10mm mV 2 20mm mV 4 40mm mV Waveform Display Accuracy Less than 10 Defibrillation Proof Provided Transient Characteristic 3 2 sec 0 3 sec 0 1 sec time constant can be changed Respiration Method Impedance Method Frequency Characteristic 1 5Hz Adult Child 2 5Hz Neonate Current 100μA or less Measurement Range 0 4 to 150Bpm Measurement Accuracy 3 Bpm Waveform Display Accura...

Страница 29: ...red light Approx 905nm infrared light Output 15mW or less Measurement Method Masimo Rainbow R Sensor Wavelength 8 different wavelengths are used within the range of 610nm to 905nm Output 25mW or less Measurement Range 1 to 100 Resolution 1 Measurement Accuracy Adult 70 to 100 2 Neonate 70 to 100 3 PR Measurement Range 26 to 239bpm PR Accuracy 3bpm when 26 to 239bpm without body motion Measurement ...

Страница 30: ...8 wavelengths spectroscopic measurement method Measurement Range 1 to 99 Resolution 1 Measurement Accuracy 1 to 40 3 SpMet Arterial Oxygen Saturation MASIMO Unit HS 8312M Measurement Method Masimo Rainbow R SET 8 wavelengths spectroscopic measurement method Measurement Range 1 to 99 9 Resolution 0 1 Measurement Accuracy 1 to 15 1 Analog Waveform Output Output Voltage ECG output 1V mV fixed BP outp...

Страница 31: ...Names of Parts and Their Functions Chapter 3 Name of Parts and Their Functions 3 2 HS 8312N 8312M 3 2 Front Side 3 2 Rear Side 3 2 Left Side 3 3 3 1 ...

Страница 32: ...tatus Alarm Suspend Key Suspends the alarm NIBP start stop Key Starts stops the NIBP measurement ECG Connector Connects ECG relay cable Multiconnector Connects the relay cable for BP TEMP or CO NIBP Connector Connects the NIBP air hose AUX Connector Connects the HPD 800 Gas Unit I F SpO2 Connector Connects the SpO2 sensor or relay cable patient cable Rear Side HS Adapter Connector Connects the HSA...

Страница 33: ...ety hazard z Do not connect other than an analog output cable specified for the HS 8000 series to analog output connector If done so by mistake the equipment cannot deliver its maximum performance and the connected units may be damaged resulting in a safety hazard z Do not connect the HS 8000 series analog output cable to the device other than main unit If the cable is connected to the other devic...

Страница 34: ...3 4 Blank Page ...

Страница 35: ... Block Diagram 4 11 Analog Board Circuit Explanation 4 12 Multi AMP Board Block Diagram 4 16 Multi AMP Board Circuit Explanation 4 17 Mother Board Block Diagram 4 20 Mother Board Circuit Explanation 4 21 NIBP Module NIBP 801 4 25 NIBP 801 Module Configuration Diagram 4 25 NIBP Module Board Block Diagram 4 26 NIBP Module Board and Display Panel Board Circuit Explanation 4 27 ...

Страница 36: ...4 2 Super Unit HS 8000 The diagram below explains the block diagram of the HS 8000 and its function HS 8000 Main Unit Configuration Diagram NIBPUnit ...

Страница 37: ...2220 MX 1 Flex Instrument Cable MX 1 HS 8000 External Equipment Connector AUX Connector No Signal Type Note Signal Level 1 12V 12V 2 12V 12V 12V power supply 500mA 3 P_GND Power GND 4 P_GND Power GND 5 5V 5V 6 5V 5V 5V power supply 300mA 7 D_GND Digital GND 8 D_GND Digital GND 9 TxD Serial Transmission Data Output RS232C 10 RxD Serial Receive Data Input RS232C 11 RESET RESET Signal Output Negative...

Страница 38: ...nection SD Card Slot No Signal Type Note Signal Level 1 DAT3 CS Data Signal 3 2 CMD DI Command Signal 3 VSS GND 4 VDD Power Supply 5 CLK SCLK Clock 6 VSS GND 7 DAT0 DO Data Signal 0 8 DAT1 RSV Data Signal 1 9 DAT2 RSV Data Signal 2 10 CARD_DETECT Card Detection Signal 11 COMMON Common Signal GND 12 PROTECT Card Protect Detection Signal 13 SHIELD Shield GND 14 SHIELD Shield GND pin3 pin2 pin1 pin6 ...

Страница 39: ...ART3 UART2 TPU PWM Membrane Connector UART I2C UART0 UART1 UART4 MPX MPX Control I Oポート SD Card Slot Analog Board Connector UART5 Buzzer WDT EtCO2 UNIT Connector RTC I2C Thermistor LOCAL BUS CMD DATA CLK Mother Board Connector SD Card Controller EEPROM FLASH MEMORY SRAM SDRAM Dip SW 100Base T FPGA I O port ...

Страница 40: ...T Monitoring Power Supply WDT Monitoring Power Supply will reset the system when the program functionsabnormally or a power voltage reduction of CPU is detected A D Converter The CPU built in A D converter always monitors each power voltage on the board board temperature inside housing temperature and each status FPGA FPGA communicates with and measure ECG board RTC Real Time Clock RTC Real Time C...

Страница 41: ...all data Module LAN Module LAN is the LAN interface to communicate between the main unit and special protocol and is controlled by a special controller The basic insulation is installed in the I O signal line of this interface GAS Unit I F GAS Unit I F is equipped with control circuit to supply power and RS 232C to the interface circuit ...

Страница 42: ...M_VER I Mother board version signal 12 12V_ POD For Gas Unit 12V 37 ANA_V_ DOWN I Power Supply Status signal for A OUT 13 GND Signal GND 38 5V_SH UT O 5V Power Supply Control Signal 14 GND Signal GND 39 GND Signal GND 15 RDP I LAN Receive Signal 40 GND Signal GND 16 TDP O LAN Transmission Signal 41 CHG_A D I Reserved 17 RDN I LAN Receive Signal 42 3 3V 3 3V 18 TDN O LAN Transmission Signal 43 CHG_...

Страница 43: ...CG board TEMP signal 25 P_M_DE TECT I Pacemaker detection signal 11 ECG_T X O ECG Communication TXD 26 E_5V_F AIL I ECG board power supply status signal 12 ECG_R X I ECG Communication RXD 27 5V 5V 13 ECG_C LK O Reserved 28 5V 5V 14 ECG_ RESET O RESET for ECG board 29 GND Signal GND 15 GND Signal GND 30 GND Signal GND Membrane Key Connector CN4 No Signal Type Note 1 ZERO_LED Zero Balance LED contro...

Страница 44: ...ND Digital GND 8 D_GND Digital GND 9 TXD TXD for GAS Unit I F 10 RXD RXD for GAS Unit I F 11 RESET Reset Signal Negative Logic 12 POD_ON GAS Unit I F detection signal 13 POD_DETECT GAS Unit I F control signal 14 RESET Reset Signal Positive Logic ICE Connector CN1 No Signal Type Note Signal Level Due to factory adjustment no description ...

Страница 45: ...3 a3 4 a4 b1 b2 b3 b4 5 6 7 8 Vcc1 0 GND 0 HPF LPF Pace Maker Detect ADC ADC ADC ADC ADC ADC ADC ADC ADC RA LA V1 V2 V3 V4 V5 V6 LF RF ADC Detect ADC MUX DC ADC G A 8bit Shift Register Latch HPF LPF TxD RxD RESET LF RESP RA RESP ECG ISO DC DC EEPROM MUX DC DC ...

Страница 46: ...G A D value for Lead OFF the detached electrode is detected Since all ECG signals take differential to the left leg the A D converter converts to detect the detached electrode only for the left leg aside from ECG Pacemaker Detection Pulse Amplitude 2 to 700mV Pulse Width 0 1 to 2ms ECG input signal is received in buffer amplifier and combined in the lead set from CPU by a multiplexer Pulse is outp...

Страница 47: ...putted to the gate array Subsequent process is the same as 4 5 10 ECG electrode To stop impedance detection By setting the main unit oscillation can be stopped Internal connector Connector wired inside ECG CN1 No Signal Type Note 1 RA RA signal 2 C2 C2 signal 3 LA LA signal 4 C3 C3 signal 5 RF RF signal 6 C4 C4 signal 7 LF LF signal 8 C5 C5 signal 9 C1 C1 signal 10 C6 C6 signal 11 GND Signal GND 1...

Страница 48: ... 6 12V 12V 21 E_R_SD A I O ECG board EEPROM data signal 7 12V 12V 22 E_R_SC L I ECG board EEPROM clock signal 8 12V 12V 23 3 3V 3 3V 9 ECG_B _VER I ECG board version signal 24 GND Signal GND 10 ECG_B _TEMP I ECG board TEMP signal 25 P_M_DE TECT O Pacemaker Detection Signal 11 ECG_T X I ECG communication TXD Receiving from CPU board 26 E_5V_F AIL O ECG board power supply status signal 12 ECG_R X O ...

Страница 49: ...GND Signal GND 3 12V 12V 13 3 3V 3 3V 4 12V 12V 14 GND Signal GND 5 P_GND Power GND 15 MLT_TX O Multi AMP communication TXD 6 P_GND Power GND 16 MLT_RX I Multi AMP communication RXD 7 P_GND Power GND 17 MLT_R ST O RESET for Multi AMP board 8 P_GND Power GND 18 GND Signal GND 9 5V 5V 19 RSRV Reserved 10 5V 5V 20 RSRV Reserved ...

Страница 50: ...7315 IBP TEMP1 Tb TEMP2 Ti IBP IBP_Vexe MUX 8 in 1 MUX Ref TEMP1 Tb TEMP2 Ti GND IBP IBP TEMP1 Tb TEMP2 Ti IBP IBP_Vexe MUX 8 in 1 MUX Ref TEMP1 Tb TEMP2 Ti GND IBP Multi CH1 Multi CH2 ADC SpO2 Unit CPU EEPROM 1 Wire MUX Tb_Vexe MUX Tb_Vexe Multi ISO DC DC ...

Страница 51: ...nd transferred to the CPU board YSI 700 Detection YS 700 is detected by distinguishing the difference between YSI 700 series Thermistor which has 3 electrode plug and YSI 400 series Thermistor which has 2 electrode plug If there is the potential difference in 2 terminals which should be in the same electric potential in YSI 400 series the terminals are detected as YSI 700 CO CO assigns Multiparame...

Страница 52: ...EMP1 I CH2TEMP1 signal 12 CH1_TI TE MP2 I CH1TEMP2 signal 27 CH2_TI T EMP2 I CH2TEMP2 signal 13 CH1_VEX C_TB O EXC voltage for CH1TEMP 28 CH2_VEX C_TB O EXC voltage for CH2TEMP 14 CH1_MLT_ PRB I CH1 cable unit type signal 29 CH2_MLT _PRB I CH2 cable unit type signal 15 SHIELD Shield GND 30 SHIELD Shield GND Multiparameter 2ch Connector CN2 No Signal Type I O Note No Signal Type I O Note 1 CH3_BP1 ...

Страница 53: ...utput 9 RxD Receive Data NELL 3 input 10 5VA Analog Power Supply 11 CTS CTS NELL 3 input 12 GND 13 5VF Power Supply 14 GND ECG Board Connector CN6 No Signal Type I O Note No Signal Type I O Note 1 12V 12V 11 GND Signal GND 2 12V 12V 12 GND Signal GND 3 12V 12V 13 3 3V 3 3V 4 12V 12V 14 GND Signal GND 5 P_GND Power GND 15 MLT_TX I Multi AMP Communication TXD Receiving from ECG board 6 P_GND Power G...

Страница 54: ...4 20 Mother Board PCB 7316 Mother Board Block Diagram Module LAN Hot Swap DC DC CPU Connector D A Analog Out ECG OUT 1 IBP OUT 2 TxD RxD NIBP Unit Connector DC Power ...

Страница 55: ...pply of Gas Unit I F Module LAN Interface Circuit Pulse transformer for Module LAN interface is set up Analog Output Circuit Analog waveforms of ECG waveform 1CH and IBP waveform 2CH are outputted Serial interface signal from CPU board is converted into D A and outputted Also analog output part provides basic insulation withstanding voltage 1 5kV Specification of analog output is as follows Range ...

Страница 56: ... LAN Reception 4 PWR_ENA Power Supply Enable Signal 5 GND GND 6 TX_LAN Module LAN Transmission 7 RESET Power Supply Control Reset Signal 8 GND GND 9 TX_LAN Module LAN Transmission 10 12Vin HS 8000 Power Supply 11 12Vin HS 8000 Power Supply 12 GND GND 13 12Vin HS 8000 Power Supply 14 12Vin HS 8000 Power Supply 15 GND GND ...

Страница 57: ...For Gas Unit 12V 36 M_VER O Mother board version signal 12 12V_ POD For Gas Unit 12V 37 ANA_V_ DOWN O Power Supply Status signal for A OUT 13 GND Signal GND 38 5V_SH UT I 5V Power Supply Control Signal 14 GND Signal GND 39 GND Signal GND 15 RDP O LAN Reception Signal 40 GND Signal GND 16 TDP I LAN Transmission Signal 41 CHG_A D I Reserved 17 RDN O LAN Reception Signal 42 3 3V 3 3V 18 TDN I LAN Tra...

Страница 58: ... NIBP Serial Transmission Data 10 RX232 NIBP Serial Receive Data 11 12V_P NIBP pump activation power supply 12 12V_P NIBP pump activation power supply 13 GND_P NIBP Pump power supply GND 14 GND_P NIBP Pump power supply GND 15 TTL 232C Communication Interface Selection 16 RESERVE Reserved Analog Output Connector CN5 No Signal Type Note 1 ECG_OUT ECG Analog Output 2 IBP1_OUT IBP Analog Output1 3 IBP...

Страница 59: ...nt exhaust valve to reduce the internal pressure of the cuff at a constant rate and rapid exhaust valve which exhausts air from the cuff when the measurement ends or an error occurs NIBP 801 Module Configuration Diagram Cuff Connecting Port PCB 7342 CN6 Constant Exhaust Valve CN5 CN3 CN4 Mother Board Pressure Sensor 1 Manifold Pressure Sensor 2 Rapid Exhaust Valve Pump CN2 ...

Страница 60: ... Pressure Sensor 1 DC DC Converter Pump Drive Circuit DC Power Supply Control Circuit Sub CPU A D Converter Pressure Sensor 2 Constant Exhaust Valve Circuit Rapid Exhaust Valve Circuit to Mother Board PCB 7316 EEPROM 7 Segment LED 4 Switch 3 Air hose identification circuit ...

Страница 61: ...l to analyze pulse wave in Main CPU Pressure Sensor 1 Output Signal is converted into A D by the A D converter and transmitted to Main CPU Pressure Sensor 2 Output is used as a signal to monitor anomalous pressure converted into A D by built in A D converter in Sub CPU and its signal process is performed Pressure Pump Drive Circuit Using PWM control signal of Main CPU the circuit controls pump rot...

Страница 62: ...4 28 Blank Page ...

Страница 63: ...Spare Parts List Chapter 5 The spare parts in this chapter mainly include electrical parts and cables inside equipment HS 8000 Main Unit Block Spare Parts 5 2 NIBP Module NIBP 801 Spare Parts 5 2 5 1 ...

Страница 64: ...6C0115810 Multiconnector with 1CH FFC cable DS8000 FPC1 1M0101990 NIBP Connector Cable 1M0102160 NIBP 801 I F Cable TCSD 08 D 02 00 01 F N 9D0111130 Membrane Sheet HS 8000 Membrane Switch sheet The spare parts cables of the HS 8000 main unit are as follows Item Code Item Name Note 1M0102170 Cable wired inside ECG 1M0102200 POD Connector Cable 1M0102210 Analog output cable NIBP Module NIBP 801 Spar...

Страница 65: ...mbly1 HS 8312M 01A 6 2 HS 8312M Assembly2 HS 8312M 02A 6 3 HS 8312M Assembly3 HS 8312M 03A 6 4 HS 8312M Assembly4 HS 8312M 04A 6 5 HS 8312N Assembly1 HS 8312N 01A 6 6 HS 8312N Assembly2 HS 8312N 02A 6 7 NIBPS 801 Assembly NIBP 801 01A 6 8 6 1 ...

Страница 66: ...HS 8312M Accembly1 HS 8312M 01A 6 2 ...

Страница 67: ...HS 8312M Assembly2 HS 8312M 02A 6 3 ...

Страница 68: ...HS 8312M Assembly3 HS 8312M 03A 6 4 ...

Страница 69: ...HS 8312M Assembly4 HS 8312M 04A 6 5 ...

Страница 70: ...HS 8312N Assembly1 HS 8312N 01A 6 6 ...

Страница 71: ...HS 8312N Assembly2 HS 8312N 02A 6 7 ...

Страница 72: ...6 8 NIBPS 801 Assembly NIBP 801 01A ...

Страница 73: ...Software Upgrade Procedure Chapter 7 Software Upgrade 7 2 Upgrading method using the HS 8000 7 2 Upgrading method using the Main Unit 7 5 Software Version 7 6 7 1 ...

Страница 74: ...rading is performed using a Compact Flash Card for software upgrading hereafter CF Card The software of the Main CPU board Multi AMP board each CPU software of NIBP module can be upgraded Copy the program file to be installed in the SD Card or CF Card Upgrading method using the HS 8000 1 Remove the HS 8000 from the HSA 80 Hold down the Lock Release Button and pull out the HS 8000 2 On the bottom o...

Страница 75: ... with the Module LAN connecting cable and then turn on the power of the Main Unit The installation of the program file in the SD Card will automatically start During software upgrade each LED at the top of the front side repeatedly light up and off The following can be possible causes if the installation is not performed The program files are not in the SD Card The SD Card is not formatted Boot bl...

Страница 76: ...ftware upgrade is completed 6 Remove the HS 8000 and open the slot cover in the same manner as 1 and 2 remove the SD Card and attach the HS 8000 again 7 Confirm that the power is supplied Power Supply LED turns in green and make sure that no error messages are displayed on the Main Unit 7 4 ...

Страница 77: ...040 10 06 11 SUPER MODULE HS 8000 3 Press the Start Install key The installation of the program file in the CF Card will automatically start The progress bar indicator displays the progress of the installation The following can be possible causes if the installation is not performed The program files are not in the CF Card The CF Card is not formatted for the DS 8000 series Boot block was deleted ...

Страница 78: ...enu Maintenance The software version of the HS 8000 will be displayed Main CPU BOOT Multi AMP MPA NIBP Module Main and Sub Check if the installed version is displayed V01 01 0012 10 03 28 V01 01 0130 10 05 14 V01 01 0006 V01 01 0012 V01 01 0008 10 03 31 V01 01 0008 10 03 31 V01 01 0008 10 03 31 V01 01 0008 10 03 31 V01 01 0013 10 05 06 HS 8312N V01 01 0038 10 05 11 7 6 ...

Страница 79: ...g Chapter 8 HS 8000 series Super Unit 8 2 ECG 8 3 Respiration 8 6 Non Invasive Blood Pressure 8 7 SpO2 HS 8312N 8 10 SpO2 HS 8312M 8 11 Invasive Blood Pressure 8 13 Temperature 8 13 CO Measurement 8 14 Analog Output 8 17 ...

Страница 80: ...Unit is malfunctioning Solution Immediately turn off the power and stop using the device The HS 8000 Out of Operating Temp Range is displayed on the main unit Cause The inside temperature of the Super Unit is too high Solution The operation cannot be assured Immediately turn off the power and stop using the device The HS 8000 Analog Unadjuted is displayed on the main unit Cause Any of ECG Respirat...

Страница 81: ...s defective replace it If any noise source is near the patient move it away from the patient as far as possible Cause 3 Even though the 3 lead Override ECG Parameter Setup Screen is set to ON electrodes other than L R F are connected Solution Set the 3 lead Override to OFF Or detach the electrodes other than L R F ECG waveform of the main unit contains noise The Artifact message is displayed on th...

Страница 82: ...xxx Cause The heart rate is outside the measurement range Solution Check the electrode application Replace the electrode or check the lead cable Heart rate is not counted Heart rate is low Cause The ECG waveform amplitude is below the QRS detection level 0 3mV Solution 1 Change the electrode site or select a lead with higher QRS amplitude Caution Using 4 electrode 5 electrode or 10 electrode inste...

Страница 83: ... the main unit Cause While the ECG is being monitored the relay cable is unplugged Solution 1 To silence the alarm press the Alarm Silence key Solution 2 To continue monitoring plug in the relay cable This will clear the message and silence the alarm The Cannot Analyze or ECG EMG Interference message is displayed on the main unit Cause A noise is interfering on the ECG and arrhythmia analysis is s...

Страница 84: ...e respiration waveform amplitude is below the detection level 0 2Ω Solution 1 Change the electrode site Solution 2 Increase the waveform size of the main unit Cause 2 The impedance respiration measurement has ceased on the main unit Solution Turn ON the impedance respiration measurement on admit discharge or RESP Parameter Setup menu of the main unit Caution If the pacemaker with the minute ventil...

Страница 85: ...ame message is displayed again a failure of the equipment can be considered Cause 2 The air hose is disconnected Solution Check if the air hose is tightly connected and then measure again If the same message is indicated air may internally leak The NIBP Check patient type air hose message is displayed on the main unit Cause Although an air hose for Adult or Child is connected the patient classific...

Страница 86: ...or and measure Cause 2 The air hose is clogged after it is bent or pressed during measurement Solution Check the air hose for any bend or press and then measure C04 xx Inflation for the patient blood pressure is insufficient Cause Blood pressure significantly increases from the previous measurement Solution Check the cuff application or size perform manual measurement C05 xx C06 xx The pulse signa...

Страница 87: ...or E08 09 Air hose identification error E09 A Maximum cuff pressure is exceeded E09 B Inflation time has been exceeded E09 C Quick mode timeout E09 D Measurement started during the long term mode pause period E09 E Measurement Time Over E09 F Timeout of pressure data transmission from main CPU E09 G Pressure Sensor 1 5V Power Supply Failure E09 H Zero Calibration Timeout E09 I ROM Test Error Sub C...

Страница 88: ... displayed on the main unit Cause The amplitude of the pulse waveform is too low or the sensor is not positioned correctly Solution Check if the light emitting and light receiving parts of the sensor LED are aligned The SpO2 No Pulse Detect message is displayed on the main unit Cause The amplitude of the pulse waveform is too low or the sensor is not positioned correctly Solution Check if the ligh...

Страница 89: ...es in the HS 800 series Super Unit Operation Manual The SpO2 Disconnected message is displayed on the main unit Cause The SpO2 relay cable is disconnected during monitoring the SpO2 Solution 1 To cease monitoring press the Alarm Silence key to clear the message and silence the alarm Solution 2 To continue monitoring plug in the SpO2 relay cable This will clear the message and silence the alarm SpO...

Страница 90: ...energy is interfering with the measurement Solution Remove the external interference The SpO2 Check Sensor Conn message is displayed on the main unit Cause Unrecognizable sensor is connected Solution Replace the sensor The SpO2 Low Signal IQ message is displayed on the main unit Cause There is excessive body motion or the sensor position is not appropriate Solution 1 Check if the light emitting an...

Страница 91: ...on Perform zero balance again The BP Disconnected message is displayed on the main unit Cause While blood pressure is being monitored BP relay cable has been disconnected from the 2ch BP Conversion Cable Solution 1 To cease monitoring press the Alarm Silence key to clear the message and silence the alarm Solution 2 To continue monitoring plug the 2ch BP Conversion Cable in the BP relay cable This ...

Страница 92: ...Multiconnector This will clear the message and silence the alarm CO Measurement For consecutive measurements the measurement value on the main unit varies 10 or more Cause 1 The injection method is not appropriate Solution Inject within 1 to 3 seconds Cause 2 Injection temperature is not appropriate Solution If iced injectate is used pay attention not to warm the injector with hands Cause 3 The th...

Страница 93: ... wait for 30 to 60 seconds and check that Ready is displayed before performing the next measurement The thermodilution curve displayed on the main unit is low The PEAK FAULT message is displayed on the main unit Cause The peak of the thermodilution curve can not be detected 22 sec 45 sec After the measurement starts the peak of the thermodilution curve was not determined within 22 seconds when the...

Страница 94: ...ilence the alarm The Check CO2 Airway Adapter is displayed on the main unit Cause 1 The airway adapter is unclean Solution A clean airway adapter must be used If reusing an airway adapter clean and air dry it Then wipe the window with a swab and sterilize EOG etc before use Cause 2 The airway adapter is disconnected from the sensor Solution 1 Securely connect the airway adapter to the sensor Solut...

Страница 95: ...utputted Cause The external output cable is wrongly wired Solution Properly connect the ECG waveform of external output cable green and the ground Shielded wire Note 1V 1mV 10 1kΩ to Ω Terminal The BP waveform is not outputted Cause The external output cable is wrongly wired Solution For BP waveform1 properly connect BP1 white and ground shield For BP waveform2 properly connect BP2 black and groun...

Страница 96: ...8 18 Blank Page ...

Страница 97: ... 8000 DIP Switch Setup 9 2 Test Menu 9 3 To Display the Test Menu 9 3 Test Menu Description 9 3 Test Menu Details 9 5 Storage 9 17 Storing the Device 9 17 Cleaning 9 18 Cleaning the Housing 9 18 Periodic Replacement 9 19 Replacement of NIBP Unit 9 20 ...

Страница 98: ... mode 7 OFF Use only for factory adjustment AUX debug mode 8 OFF Force Installation EEPROM Installation 1 When the power is turned ON with this mode the user settings will be initialized 2 Set up only when installing the software upgrading boot program 5 Set this function OFF for ordinary use since this function is used for factory inspection and periodical check 6 Set this function OFF for ordina...

Страница 99: ...oftware version Test Menu Description Analog Parameter Indicate all the parameters numeric data measured in the DS 8500 system MAINTENANCE HS 8000 The hardware information of the HS 8000 can be checked on this display For details refer to the section of MAINTENANCE HS 8000 MAINTENANCE M_LAN The Module LAN information of the equipment can be checked on this display MAINTENANCE MODULE I F The Module...

Страница 100: ...urs This information can be used to find solution when equipment failure occurs Maintenance CO2 Displays the status of the EtCO2 measurement unit When measurement interference occurs write down the status and contact our service representative CF Card Is used when the SD card used for HS 8000 needs to be formatted Do not format the SD card when the patient data storage function Trend Tabular Trend...

Страница 101: ...3V 0202h 3 31 V OK NIBP OK 00000000 00000000 00000000 00000000 5V SpO2 02FAh 4 92 V OK POD OFF 00000000 00000000 00000000 00000000 5V AMP 0305h 5 00 V OK SpO2 OK 00000000 00000000 00000000 00000000 Board Temp 01BCh 40 0 degC OK Version 0136h 1 Task Performance min max real stack size Main us 20 374776 8024 907 1ms us 8 288 108 1953 4ms us 352 924 648 2002 24ms us 20 2808 52 1880 100ms us 164 6808 ...

Страница 102: ...packet count byte count Display Interrupt Interrupt packet count byte count Display Module LAN Error counter Displays Module LAN communication error status MAINTENANCE M_LAN This is the status for development MAINTENANCE MODULE I F This is the status for development NIBP Test NIBP function test is conducted Pressing the START STOP key for each test item will start each test Pressing ALL TEST START...

Страница 103: ...n be considered Constant displacement 10mmHg sec Deflation speed control high speed deflation of the Constant Exhaust Valve is tested If the test result is NG malfunction of the NIBP module Constant Exhaust Valve can be considered Rapid displacement Deflation control of Rapid Exhaust Valve is tested If the test result is NG malfunction of the NIBP module Rapid Exhaust Valve can be considered NIBP ...

Страница 104: ...ates current status ALARM STATUS Alarm Status of the unit is displayed OXISMART STATUS The operating condition is displayed SENSOR CONDITION SENSOR MESSAGE The operating condition of the sensor is displayed ERROR STATUS Error condition of the SpO2 measurement unit is displayed SERIOUS ERROR MODULE ERROR REQUIRES RESET TRANSIENT ERROR COMMUNICATION ERROR Sensor Condition ...

Страница 105: ...asurement unit SENSOR TYPE Used sensor information is displayed USER SELECTED Information such as measurement mode set on the monitor is displayed BOARD FAILURE CODE When the SpO2 module is malfunctioning the code indicates malfunctioning status Arrhythmia Analysis This is a status for development Log 1 HS 8000 This is a status for development ...

Страница 106: ...nostat 5 Current ETCO2 Time Period Displays EtCO2 measurement time set on the Capnostat 5 Current CO2 Unit Displays the CO2 Unit set on the Capnostat 5 Sleep Mode Displays operating mode set on the Capnostat 5 For standard usage Normal Operating Mode is displayed Zero Gas Type Displays calibration mode set on the Capnostat 5 For standard usage zero on room air is displayed Gas Compensation Display...

Страница 107: ...xx xx xx 04 Capnostat 5 sleep mode Capnostat 5 is in sleep mode xx xx xx xx 05 Capnostat 5 is zeroing Capnostat 5 is in Zero Calibration xx xx xx xx 06 Capnostat 5 is Warming Up Capnostat 5 is in warm up condition xx xx xx xx 07 Zero calibration for Capnostat 5 is required Capnostat 5 is in need of Zero calibration xx xx xx xx 08 Out of CO2 range for Capnostat 5 CO2 numeric data of Capnostat 5 bec...

Страница 108: ...TION This unit does not correctly operate with the SD Card formatted using general computers Make sure to format the SD Card on this unit This unit does not correctly operate with the SD Card formatted for other products Make sure to format the SD Card used for the HS 8000 using this unit If the SD Card is formatted the data in the SD Card will be deleted Do not format on an SD card with the patie...

Страница 109: ...e tools Measurement Device For Analog Adjust prepare the following adjusting jig and measurement device Item Model Type Note Comprehensive tester MEDSIM300 FLUKE ECG RESP BP Standard voltage and current generators 2554 or equivalent Yokogawa Electric Corporation ECG The following adjusting jig can be used as the above used jig and measurement device For how to adjust when the following adjusting j...

Страница 110: ...inus terminal of the Standard voltage and current generator Connect the other electrodes to the plus terminal of the Standard voltage and current generator 3 Set the output of Standard voltage and current generator to 800mV and output the voltage 4 Press the Gain key 5 After the adjustment press the Prev Disp key and then YES key in the message to check that the adjustment data updates the adjustm...

Страница 111: ...eck that RESP waveform becomes stable and press the offset gain key 5 Press the II Lead key 6 Set up the comprehensive tester as follows Base Impedance 1500Ω Lead Select II Rate 60Bpm Ohm 1 0Ω Ratio 1 1 Ins Exp 7 Check that RESP waveform becomes stable and press the offset gain key 8 After the adjustment press the Prev Disp key and then YES key in the message to check that the adjustment data upda...

Страница 112: ...g 3 Press the offset key 4 Set up the comprehensive tester output to 100mmHg or 250mmHg 5 According to the comprehensive tester output press the Gain key Gain 100mmHg key or Gain 250mmHg key 6 After the adjustment press the Prev Disp key and then YES key in the message to check that the adjustment data updates the adjustment data ...

Страница 113: ...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 Storage Humidity 10 to 95 at 60 C Storage Atmospher...

Страница 114: ...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 powder ...

Страница 115: ...y starts Back up the Setup and Patient Data in the CF Card just in case For details on how to back up the data in the CF Card refer to the DS 8500 system Operation Manual Operation before disassembling the case CAUTION Make sure to conduct the operation below to prevent electric shock or breakdown and deterioration of electronic parts by electrostatic discharge Main Power Switch OFF Unplug Power C...

Страница 116: ... of NIBP measurement Displays the number of measurement since the beginning of use Use only as a guide for NIBP unit replacement 1 Press the Menu Maintenance Usage Time keys The Usage Time window will be displayed The number of NIBP measurement will be displayed Disassemble and assemble Pay attention to wiring and tubing and follow the procedure below to replace 1 Remove the screws x 3 on the rear...

Страница 117: ...crews x3 Disconnect the following connectors membrane key ECG and AUX and remove the front panel 6 Remove the screws x3 on the mother board and remove the mother board 7 Remove the screws x3 on the CPU board and the screw on the bottom side x1 and remove remove the CPU bracket2 8 Disconnect the NIBP Receptacle Connector and Silicone Tube and then remove the NIBP unit ...

Страница 118: ... in a stress free situation If the air connector is under stress BP cannot be correctly measured since the connector is loose and the air leaks 10 Turn ON the power with the Rotary SW of the DSC 8500 to C then press the Menu Maintenance Usage Time keys press the RESET key in the NIBP Meas Frequency on the Usage Time screen and reset the NIBP Measurement Frequency And then return the Rotary SW of t...

Страница 119: ...ly Check 10 2 Periodic Check 10 2 Periodic Replacement Period for Each Part 10 2 Daily Check 10 3 Daily Check Procedure 10 3 Daily Check List 10 4 Periodic Check 10 5 Introduction 10 5 Service tools Measurement Device 10 5 Periodic Check Item 10 6 Periodic Check Procedure 10 6 Periodic Check List 10 12 10 1 ...

Страница 120: ...lcohol or other liquids from getting into the device Daily Check Perform daily inspection using the Daily Check List on the next page Periodic Check The safety check conformed to IEC 60601 must be performed at least once every 2 years Periodic inspection of medical electronic equipment is mandatory to prevent failures and accidents and to ensure safety and reliability Periodic check may be perform...

Страница 121: ... adverse environment The environmental condition ex temperature humidity of the installed place should be as specified The unit should not be subjected to splashing water 03 Cables Check that neither damage nor broken wire should be found in all cables Neither damage nor broken wire should be found 04 Periodic Check Check the date of the previous periodic check Should be within 1 year No Check Ite...

Страница 122: ...environmental condition ex temperature humidity of the installed place should be as specified The unit should not be subjected to splashing water OK NG With BP relay cable and BP transducer connected pressing the BP Zero Balance Switch should start the zero balance OK NG Pressing the NIBP Start Stop key should inflate the NIBP cuff OK NG Functions Turn ON the monitor and check if it operates norma...

Страница 123: ...ame Model Type Reference Comprehensive Tester SG 2000 or equivalent Chunichi ECG RESP BP TEMP CMRR Waveform Simulator 217A or equivalent DNI NEVADA ECG RESP BP TEMP CO Leakage Measurement Safety tester 3155 3156 or equivalent HIOKI Exterior Leakage Current Exterior Line Exterior Ground Exterior Exterior Patient Leakage Current I II III Patient Measurement Current 500cc Air Tank NIBP AC Resistance ...

Страница 124: ...on and rust Neither damage nor broken wire should be found 03 Operation Manual Instruction Check that accompanying documents such as Operational Manual or instruction are stored in specified location Should be stored in specified location No Check Item Check Procedure Criteria 2 Power Supply Part 01 Ready LED display Check by connecting the power cable of the main unit and turning the switch ON OF...

Страница 125: ...nt Mode 15Hz 3dB or more Baseline filter should be OFF 05 Heartbeat rhythm detection With comprehensive tester input both positive and negative polarity of 0 3mV and 3mV with sensitivity 1 and check if the heartbeat rhythm is detected Comply with the test method of IEC60601 2 27 2005 50 102 15 The heartbeat rhythm should be detected with sensitivity 1 and bipolar signal of 0 3mV and 3mV 06 ECG Dis...

Страница 126: ... 2mm 02 Respiration Rate display accuracy Input the reference respiration signal to the comprehensive tester or respiration simulator and check the respiration rate display Test at respiration reference load signal in 60 or 120 per minute NOTE Check with I Lead and II Lead Measurement error should be within 5bpm or less 03 Frequency Characteristic 1 Input 0 5Hz 1 5Hz or 2 5Hz from the comprehensiv...

Страница 127: ...ure pulse rate error Error should be within the below range Nellcor HS 8305N HS 8312N 3bpm from 20 to 250bpm Masimo HS 8305M HS 8312M 3bpm from 26 to 239bpm Measure healthy people using other reference equipment and compare the numeric data Error between two devices should be within 6 03 SpO2 Probe off detection Check the display by connecting and disconnecting the probe Waveform and numeric data ...

Страница 128: ...edure Criteria 11 External Output Analog Output 01 ECG output accuracy Input ECG using a comprehensive tester Connect oscilloscope to output and observe the waveform Should be within 10 of output 1V to input 1mV Should be within 0 1V to input 0mV 02 BP output accuracy Input BP using a comprehensive tester Connect oscilloscope to output and observe the waveform Should be within 10 of output 1V to i...

Страница 129: ... DSC 8500 and measure According to test procedure of IEC 60601 1 19 Patient Current NC 0 01mA 05 Patient Current SFC Measure single failure patient current SFC using a leak measurement safety tester Connect with the DSC 8500 and measure According to test procedure of IEC 60601 1 19 Patient Current SFC 0 05mA No Check Item Check Procedure Criteria 13 Electrical Safety Perform the following check it...

Страница 130: ...tails of malfunction and repair Checked by Consignee Lead Cable SpO2 SpO2 Accuracy Not applicable BP Accuracy Analog Replace Pulse Detection Accuracy BP Withstand Voltage Test B a Temperature Temperature display error Automatic Check Recording Sensitivity CO Accuracy Frequency Characterist ECG Sensitivity CO Temperature Measurement Input Impedance Suppression Characteristic of Common Mode Signal E...

Страница 131: ...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...

Страница 132: ...39 4 Hongo 3 chome Bunkyo ku Tokyo Japan Phone 81 3 3815 2121 Fax 81 3 3814 1222 Printed in Japan 4R0100640 201108 ...

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