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SECTION IX APPENDICES

Safety Testing: Leakage Current

Leakage Current testing should be performed by a qualified Biomedical
Engineering Technician or authorized personnel only.

Connect sensor simulator to the patient interface cable of the BIS monitor as if it was

a sensor connection.

Short the two circular terminals at the end of the simulator using conventional

methods such as jumpers or alligator clips. Wire attached with screws will work also.

Connect the test signal to the shorted terminals. Make sure that you are not touching

the simulator beyond this point.
Proceed to test instrument for Leakage current as per established facility protocols
and procedure for safety testing of medical devices.

For technical assistance contact:
Aspect Medical Systems, Inc.
Technical Service
2 Vision Drive
Natick, MA 01760

(800)442-2051 (USA)
(508)653-0603

Содержание BISPECTRAL INDEX A-2000

Страница 1: ...or on the order of a physician Copyright 1999 Aspect Medical Systems All rights reserved Copying or other reproduction of this document is prohibited without prior written consent of Aspect Medical Sy...

Страница 2: ...1 3 Cautions 2 3 2 2 KEY TO SYMBOLS 2 5 3 PRINCIPLES OF OPERATION 3 1 3 1 SYSTEM ARCHITECTURE 3 1 3 1 1 The Digital Signal Converter DSC 3 1 3 1 2 The A 2000 Monitor 3 7 3 1 3 A 2000 Printer 3 8 4 PR...

Страница 3: ...c Diagnostics 6 8 6 2 3 Manual Diagnostics 6 13 7 DISASSEMBLING AND REASSEMBLING THE A 2000 7 1 7 1 REQUIRED TOOLS AND SUPPLIES 7 2 7 2 THE MONITOR CASE 7 3 7 2 1 Opening the Monitor Case 7 3 7 2 2 Cl...

Страница 4: ...00 SPECIFICATIONS 8 1 8 1 GENERAL SPECIFICATIONS 8 1 8 1 1 Type of Protection against Electric Shock of the System 8 3 8 1 2 Degree of Protection against Electric Shock of the System 8 3 8 1 3 Degree...

Страница 5: ...h needle nose pliers 7 15 Figure 7 10 The L bracket 7 15 Figure 7 11 Gently pull and flex to separate PCBs 7 16 Figure 7 12 Line up Interconnect PCB pins to Main PCB socket 7 16 Figure 7 13 Align stan...

Страница 6: ...ttempting to set up or service the A 2000 please familiarize yourself with the safety information provided in this section Section III describes the A 2000 monitor hardware and how it operates Include...

Страница 7: ...The system is composed of a monitor and a digital signal converter with a patient interface cable PIC and BIS Sensor 1 2 1 1 Monitor The monitor contains the operator control panel an electro lumines...

Страница 8: ...Please refer to the A 2000 Operating Manual 070 0015 for additional information 1 3 INSTRUMENT IDENTIFICATION 1 3 1 A 2000 Monitor Monitor identification information is permanently marked on the rear...

Страница 9: ...SECTION I INTRODUCTION 1 4 Figure 1 1 The A 2000 BIS Monitoring System...

Страница 10: ...SECTION I INTRODUCTION 1 5 Figure 1 2 Rear View of Monitor Clamp Shoe Fuse Holder Serial Port Potential Equalization Terminal...

Страница 11: ...SECTION I INTRODUCTION 1 6...

Страница 12: ...STHETICS MAY OCCUR FOR PROPER GROUNDING THE POWER RECEPTACLE MUST BE A THREE WIRE GROUNDED OUTLET A HOSPITAL GRADE OUTLET IS REQUIRED NEVER ADAPT THE THREE PRONG PLUG FROM THE MONITOR TO FIT A TWO SLO...

Страница 13: ...ATTERY OPERATION POSSIBLE WITH NO AC CONNECTED EXTREME CARE MUST BE USED WHEN DISASSEMBLING AND ASSEMBLING THE A 2000 MONITOR WITH AC DISCONNECTED AND BATTERY POWER ON HIGH VOLTAGE IS PRESENT ON THE E...

Страница 14: ...connected from the wall socket and which has been charging the battery for at least four hours After long periods of storage e g 1 month it may be necessary to cycle discharge then charge the battery...

Страница 15: ...ality Continuous impedance checking may need to be disabled if the 1 nanoampere 128 Hz impedance check signal interferes with other equipment e g evoked potential monitors VERY IMPORTANT Use only the...

Страница 16: ...he mains OFF power disconnection from the mains Audible Alarm Silenced Operating on Battery Type BF Equipment Attention Consult Accompanying Documents J1 Attention J1 RS 232 Serial Port Consult Accomp...

Страница 17: ...SECTION II SAFETY PRECAUTIONS 2 6 Fuse Replace only with same Type and Rating Equipotential Alternating Current Dangerous Voltage Protective Earth ground Storage Temperature Limits...

Страница 18: ...gram appears in Figure 3 2 After passing through input protection circuits in the DSC the EEG signals are differentially amplified and filtered to remove DC and high frequency components The signals a...

Страница 19: ...SECTION III PRINCIPLES OF OPERATION 3 2 Figure 3 1 The A 2000 System Block Diagram...

Страница 20: ...SECTION III PRINCIPLES OF OPERATION 3 3 Figure 3 2 The A 2000 Signal Flow Diagram...

Страница 21: ...ifiers also serve as filters to prevent aliasing by the converters 3 1 1 3 DSC Impedance Testing In the default state of the DSC the combined channel electrodes impedance is continuously checked A sma...

Страница 22: ...led onto a balanced twisted pair line The transformer provides the required patient isolation The communications board decodes the control information coming from the host via a command line Commands...

Страница 23: ...SECTION III PRINCIPLES OF OPERATION 3 6 Figure 3 3 The Digital Signal Converter DSC DSC 2 Monitor Interface Cable DSC pigtail Patient Interface Cable PIC...

Страница 24: ...ock and DSC interface All software and firmware can be downloaded through the serial port 3 1 2 2 Digital Signal Processor The functions of the DSP include decimation filters for up to 2 channels of E...

Страница 25: ...ondary has two outputs which are rectified and filtered to create 5 V and 10 V outputs The 10 V signal drives a DC to DC converter to create the 12 V output and charges the battery The battery driven...

Страница 26: ...stem between heated buildings and outside storage Once moved inside allow the monitor to stabilize in the unopened shipping container at the inside ambient temperature before unpacking and placing int...

Страница 27: ...PLUG FROM THE MONITOR TO FIT A TWO SLOT OUTLET IF THE OUTLET HAS ONLY TWO SLOTS MAKE SURE THAT IT IS REPLACED WITH A THREE SLOT GROUNDED OUTLET BEFORE ATTEMPTING TO OPERATE THE MONITOR IF THE INTEGRIT...

Страница 28: ...le into the port opening with your thumb and index finger squeeze and pull back on the gray cylindrical connector housing Do not twist or pull on cord 4 2 2 Power Cord Connections The A 2000 is design...

Страница 29: ...ord Verify OPERATING ON BATTERY BACKUP E33 is displayed Verify battery icon displays in BIS banner top left corner of screen 7 Reconnect power cord Verify battery icon is not displayed in BIS banner V...

Страница 30: ...g the Monitor and Digital Signal Converter Use lint free absorbent towels dampened with 10 bleach solution or a commercial disinfectant e g Lysol Professional Disinfectant Foam Cleaner Spray or PDI Ge...

Страница 31: ...cordance with the national laws of the country Contact Aspect Medical Systems Inc or the local distributor for a replacement battery WARNING ELECTRICAL SHOCK HAZARD DO NOT REMOVE MONITOR COVERS DURING...

Страница 32: ...IED THAT THE GROUND LEAKAGE CURRENT AND THE PATIENT SAFETY CURRENT WERE LESS THAN THE SPECIFIED LIMITS ESTABLISHED BY THE APPLICABLE SAFETY STANDARDS AS A MATTER OF SAFE PRACTICE THE INSTITUTION SHOUL...

Страница 33: ...by passing impedance check or by exiting with MENU EXIT key 5 Disconnect power cord Verify OPERATING ON BATTERY BACKUP E33 is displayed Verify battery icon displays in BIS banner top left corner of sc...

Страница 34: ...ppendix 9 2 If a simulator is not available use the following procedure to make a test sensor 1 Remove a new sensor from its plastic carrier sheet and place on flat surface with the adhesive facing up...

Страница 35: ...SECTION V PREVENTIVE MAINTENANCE CARE AND CLEANING 5 6...

Страница 36: ...s The corrective procedures include replacing assemblies Corrective actions are arranged according to probability of cause Table 6 1 Troubleshooting the A 2000 Monitor Symptoms Causes Corrective Proce...

Страница 37: ...fective Replace main board Printer inoperative Printer out of paper Replace printer paper Printer off line Place printer on line A 2000 in battery backup mode Replace A C line cord power Printer defec...

Страница 38: ...r replace sensor as required Notch filter OFF Check notch filter setting DSC is defective Replace DSC Fails impedance test Electrode impedance too high Initiate impedance check re prep or replace sens...

Страница 39: ...BIS Engine and printer and can be used to check for impedance The manual diagnostics are operator initiated using the A 2000 keys and menu choices These procedures check for the proper functioning of...

Страница 40: ...useful if a hardware failure prevents the display from working Each audible error code consists of a long tone followed by one or more short tones and finally another long tone The specific error cond...

Страница 41: ...splay Host DRAM failure Replace main board 9 short tones no display Host SRAM failure Replace main board Program Memory Checks 1 short tone no display Bad checksum or signature in Boot Block Replace m...

Страница 42: ...rrupted in real time clock Check real time clock battery Data Memory Data Memory FAILED SYSTEM HALTED Data Memory failed erase or write Replace main board Data Memory ERASED DATA MEMORY LOST Check Tim...

Страница 43: ...le connections 2 Inspect repair cable at connector end 3 Replace the DSC 4 Replace the main board E02 DSC Overcurrent 1 Defective DSC cable 2 Defective DSC 3 Defective monitor 1 Replace the DSC 2 Repl...

Страница 44: ...eplace the main board E16 Last Sensor Check Failed 1 At least one electrode has too high impedance 2 Poor lead connection 3 Defective PIC 4 Defective DSC 5 EXIT pressed prematurely 1 Check impedance r...

Страница 45: ...ion or the presence of electrocautery devices 1 Re prep the Sensor 2 Check impedances E28 Bad Signal Quality The Signal Quality Index is unacceptable The Primary Trend variable cannot be calculated an...

Страница 46: ...to avoid automatic shutdown Software E35 E39 E43 E45 E48 E65 Software Error A serious software error has occurred The monitor may stop operating 1 Turn the monitor off then on again 2 Update the soft...

Страница 47: ...Corrective Actions Printer E66 Printer Out of Paper Printer is out of paper Replace the paper E67 Printer Error 1 Printer is off line 2 Print head is up 3 Printer is disconnected 4 Print head tempera...

Страница 48: ...screen will display 2 The following information appears DSC Test Results In Progress Ch1 Ch2 Noise V Hi Pass Blocked V Hi Pass Normal V Gain V The DSC test consists of four sub tests The first checks...

Страница 49: ...T to start test Press MENU EXIT to end test When SELECT is pressed the display will start to cycle through 3 test screens a All pixels on b Alternating pixels on checkerboard c Reverse of b The test w...

Страница 50: ...starting up does not have full epoch yet 7 00000080 not used 8 00000100 Total Power Too Small 9 00000200 Motion Sudden Change Low frequency or eye blink artifact detected 10 00000400 Glitch High Freq...

Страница 51: ...mode The IPU sets the DSC into the blocking state when both channels are clipped When either the left or right channel is unclipped for 1 second then blocking is turned off but the blocking artifact...

Страница 52: ...ng in the Diagnostic Menu 1 Highlight Impedance Checking then press the SELECT key until OFF appears in reverse video 2 Use the arrows to go to the next option or press MENU EXIT to exit Impedance lev...

Страница 53: ...SECTION VI DIAGNOSTICS AND TROUBLESHOOTING 6 18...

Страница 54: ...Y A QUALIFIED BIOMEDICAL ENGINEERING TECHNICIAN POWER OFF THE UNIT USING THE POWER SWITCH UNPLUG THE MONITOR BEFORE DISASSEMBLING REASSEMBLING THE A 2000 IF METAL COMES IN CONTACT WITH THE TERMINALS O...

Страница 55: ...and Main board Needle nose pliers Stripping off the switch set releasing standoff tabs to separate boards Wire cutter Cutting cable ties used to anchor battery Wrench for special connector nut 820 000...

Страница 56: ...re attach the cable 7 To remove the small flex circuit cable of the switch panel gently pry up the tension flange on the connector at the Interconnect PCB releasing the flex circuit cable See Figure 7...

Страница 57: ...ct the power cord 9 Check continuity for less than 10 Ohms between chassis ground lug on rear of monitor and pin 5 of the DSC connector on front panel of monitor Refer to section 8 2 5 for pin out inf...

Страница 58: ...SECTION VII DISASSEMBLING AND REASSEMBLING THE A 2000 7 5 Figure 7 1 Opening the Monitor Case Tape Figure 7 2 The E L Display Cable...

Страница 59: ...SECTION VII DISASSEMBLING AND REASSEMBLING THE A 2000 7 6 Flange Figure 7 3 The Keypad Cable Tension Flange...

Страница 60: ...1 Carefully position the gasket in the gasket groove with gap located at the top 2 Place the E L display board into position trapping the gasket 3 Replace the four mounting screws loosely 4 Align the...

Страница 61: ...SECTION VII DISASSEMBLING AND REASSEMBLING THE A 2000 7 8 Figure 7 4 The Four Mounting Screws...

Страница 62: ...discard switch set 5 Using isopropyl alcohol and a cloth remove any residue remaining on bezel surface Allow surface to dry completely before installing new switch set 7 4 2 Installing the New Switch...

Страница 63: ...SECTION VII DISASSEMBLING AND REASSEMBLING THE A 2000 7 10 EMI strip Figure 7 5 The Cable Access Port Figure 7 6 Remove the covering on the back of the new switch set...

Страница 64: ...or rear case shell are now ready for further service activities 7 5 2 Installing the Printed Circuit Board Assembly Refer to Figures 7 7 7 8 and 7 21 Note On newer A 2000 units copper tape has been ad...

Страница 65: ...ghten nylon screw first Do not over tighten nylon screw Then tighten L bracket screw Note It is important to follow the instructions regarding the sequence of tightening the screws in step 6 above Fai...

Страница 66: ...SECTION VII DISASSEMBLING AND REASSEMBLING THE A 2000 7 13 Equipotential Stud Flat screw Nylon screw Figure 7 7 Place rear case assembly face down on a scratch free work surface Figure 7 8 Fan Cable...

Страница 67: ...e PCBs BE CAREFUL NOT TO BEND PINS ON INTERCONNECT PCB See Figure 7 11 7 6 2 Installing the Main PCB Refer to Figures 7 9 through 7 14 1 To connect Main PCB to Interconnect assembly line up pins of In...

Страница 68: ...SECTION VII DISASSEMBLING AND REASSEMBLING THE A 2000 7 15 Figure 7 9 Release standoff tab by squeezing with needle nose pliers L bracket Figure 7 10 The L bracket...

Страница 69: ...BLING THE A 2000 7 16 Interconnect PCB Main PCB Power Supply PCB Figure 7 11 Gently pull and flex to separate PCBs Interconnect PCB pins Main PCB socket Interconnect PCB Notch Figure 7 12 Line up Inte...

Страница 70: ...II DISASSEMBLING AND REASSEMBLING THE A 2000 7 17 Figure 7 13 Align standoffs and push in until standoff tabs snap into place Figure 7 14 Install L bracket by holding long side short side connects to...

Страница 71: ...SECTION VII DISASSEMBLING AND REASSEMBLING THE A 2000 7 18 L bracket Figure 7 15 The L Bracket Installed...

Страница 72: ...UL NOT TO BEND PINS ON INTERCONNECT PCB See Figure 7 16 6 Remove battery assembly by removing four screws on rear of Power Supply PCB See Figure 7 17 7 Remove shield from rear of Power Supply PCB See...

Страница 73: ...SECTION VII DISASSEMBLING AND REASSEMBLING THE A 2000 7 20 Figure 7 16 Gently flex and pull Power Supply PCB free of pins Figure 7 17 Remove four screws on rear of Power Supply PCB...

Страница 74: ...SECTION VII DISASSEMBLING AND REASSEMBLING THE A 2000 7 21 Figure 7 18 Remove shield from rear of Power Supply PCB...

Страница 75: ...en the monitor case as described in Section 7 2 1 9 Remove the Interconnect PCB as described in Section 7 5 1 10 Disconnect battery cable by depressing securing tab and lifting connector from J300 jac...

Страница 76: ...SECTION VII DISASSEMBLING AND REASSEMBLING THE A 2000 7 23 Tie Wraps J 300 Figure 7 19 Battery and cable...

Страница 77: ...e Figure 7 20 4 Remove four mounting screws Retain fan gasket and soft washers Note Newer versions of the A 2000 have only two mounting screws 7 9 2 Installing the Fan 1 Position fan over gasket with...

Страница 78: ...A 2000 7 25 Clamp Shoe Screws Wiring Fan Mounting Screws 4 Figure 7 20 Fan wiring orientation and Clamp Shoe screws Rubber Bumper Fan Mounting Screws 2 Conductive Copper Tape Figure 7 21 Updated Syst...

Страница 79: ...Section 7 5 1 3 Remove three screws securing shoe clamp assembly See Figure 7 20 7 10 2 Installing the Clamp Shoe Assembly 1 Install screws securing clamp shoe assembly using Loctite 425 2 Install the...

Страница 80: ...the monitor 3 Locate the plastic locking tabs securing the fuse holder in place 4 Insert the tip of a ball point pen or similar tool into the slots provided to release the plastic locking tabs allowin...

Страница 81: ...SECTION VII DISASSEMBLING AND REASSEMBLING THE A 2000 7 28 Figure 7 22 Releasing the plastic locking tabs of the fuse holder Figure 7 23 Re installing the fuse holder...

Страница 82: ...rter Weight 4 7 oz 0 134 kg including integral cable Dimensions 2 60 in wide x 1 00 in high x 4 25 in deep 6 6 cm x 2 5 cm x 10 8 cm Cable Length 12 ft 3 7 m integral DSC cable 3 ft 0 9 m Patient Inte...

Страница 83: ...onds for Trend DSA Event Markers User selected Alarms Auditory and visual user adjustable limits Filters ON 2 70 Hz with notch or OFF 25 100 Hz Note Filter setting does not effect computed parameters...

Страница 84: ...is isolated from all other parts of the equipment to such a degree that the patient leakage current allowable in single fault condition is not exceeded when a voltage equal to 1 1 times the highest r...

Страница 85: ...SECTION VIII A 2000 SPECIFICATIONS 8 4 8 3 Digital Signal Converter DSC Connector LEMO 5 female...

Страница 86: ...ped by Purchaser under this warranty shall be packaged in the original shipping container or equivalent packaging to protect the Product If Purchaser ships a Product to Aspect in unsuitable packaging...

Страница 87: ...SECTION VIII A 2000 SPECIFICATIONS 8 6 LOSS OF USE OF ANY PRODUCT EXCEPT AS SET FORTH HEREIN ALL PRODUCTS ARE SUPPLIED AS IS WITHOUT WARRANTY OF ANY KIND EITHER EXPRESS OR IMPLIED...

Страница 88: ...0003 Front Bezel Assembly 1 185 0071 A 2000 DSC Assembly 1 186 0067 Patient Interface Cable PIC S 1 Patient Interface Cable only 1 channel referential for use with BIS Sensor 186 0105 Sensor Simulato...

Страница 89: ...ce cable The Inputs and are where one connects the test signals to test the BIS Monitor Test types allowed Sensor check This checks and verifies that the monitor is reporting the proper impedances tha...

Страница 90: ...he end of the simulator using conventional methods such as jumpers or alligator clips Wire attached with screws will work also Connect the test signal to the shorted terminals Make sure that you are n...

Страница 91: ......

Страница 92: ...Business Fax 508 653 6788 Customer Service 888 BIS INDE X press 6 OR 800 442 7688 press 6 Technical Service 800 442 2051 Email bis_info aspectms com Web www aspectms com Aspect Medical Systems Interna...

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