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SECTION 9 SPECIFICATIONS AND WARRANTY
_______________________________________________________________________

9-5

9.2

Electromagnetic Compatibility Specifications

The BIS VIEW Monitoring System requires special precautions regarding Electromagnetic
Compatibility (EMC). The BIS VIEW system must be installed and put into service
according to the EMC guidance information provided in this section.

Portable and mobile radio frequency communications equipment can affect the operation of
the BIS VIEW Monitoring System. Refer to the EMC guidance information and Cautions
provided in this manual.

9.2.1

Accessories

The BIS VIEW Monitoring System complies with the requirements of IEC 60601-1-2:2001
when used with the accessories listed in Section 2 of the Operating Manual. In addition, the
BIS VIEW system must be used only with the power cord provided.

When using the Software Upgrade Device to load new versions of software into the BIS
VIEW monitor, no cables or other accessories should be connected to the device. The BIS
VIEW monitor should be connected to the mains through the appropriate power cord, and
the Software Upgrade Device should be plugged into the USB-A connector on the back of
the device.

Caution:

Using accessories other than those specified may result in increased
electromagnetic emissions or decreased electromagnetic immunity of
the BIS VIEW Monitoring System.

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Summary of Contents for BIS VIEW

Page 1: ... Aspect Medical Systems Inc Aspect Medical Systems International B V One Upland Road 3454 PV De Meern Norwood MA 02062 USA Rijnzathe 7d2 0123 Tel 617 559 7000 The Netherlands Tel 888 BIS INDE X U S only Tel 31 30 662 9140 Fax 617 559 7400 Fax 31 30 662 9150 bis_info aspectms com amsint aspectms com www aspectmedical com 075 1000 1 01 ...

Page 2: ......

Page 3: ...l rights reserved Copying or other reproduction of this document is prohibited without prior written consent of Aspect Medical Systems BIS VIEW BISx and the BISx logo are trademarks of Aspect Medical Systems Inc Aspect Bispectral Index BIS the BIS logo and Zipprep are trademarks of Aspect Medical Systems Inc and are registered in the USA EU and other countries ...

Page 4: ......

Page 5: ...3 3 Monitor Data Memory 3 8 3 3 4 BISx Data Memory 3 9 3 3 5 Saved Settings 3 9 3 3 6 Battery Operation 3 9 3 3 7 Data Transfer and Software Updates 3 10 4 PREPARATION FOR USE AND INSTALLATION 4 1 4 1 ENVIRONMENT 4 1 4 1 1 Shipping and Storage Environment 4 1 4 1 2 Operating Environment 4 1 4 1 3 Power Requirements and System Grounding 4 2 4 1 4 Site Preparation Mounting the Monitor 4 2 4 2 INSTRU...

Page 6: ...8 6 8 7 1 Parts and Tools Required 8 6 8 7 2 Procedure 8 6 8 8 REPLACING THE BISX BULKHEAD CONNECTOR 8 9 8 8 1 Parts and Tools Required 8 9 8 8 2 Procedure 8 10 8 9 USING THE RESET BUTTON 8 13 8 10 BISX CHECKOUT AND SAFETY TESTS 8 13 8 11 PERFORMING A SOFTWARE UPDATE 8 14 8 12 WHAT TO DO WITH A COMPONENT THAT REQUIRES SERVICE 8 15 8 13 REPACKAGING FOR SHIPPING AND STORAGE 8 15 9 SPECIFICATIONS AND...

Page 7: ...m Block Diagram 3 2 Figure 6 The BIS VIEW Data Flow Diagram 3 3 Figure 7 Pole Clamp 4 3 Figure 8 Schematic of the BIS Sensor Simulator 10 2 Figure 9 BIS Sensor Simulator individual electrode impedance range 10 3 Figure 10 BIS Sensor 10 4 Figure 11 Connecting electrodes 2 and 4 10 4 Figure 12 Connecting electrode 3 with 4 and 1 with 2 10 4 Figure 13 Safety Tester Contact Points 10 6 ...

Page 8: ...therefore limited by design to replacement of major component assemblies such as the Patient Interface Cable PIC BISx the BIS VIEW monitor or the monitor s power supply and battery This manual in conjunction with the BIS VIEW Monitoring System Operating Manual contains the maintenance and diagnostic troubleshooting information necessary for customer qualified technical personnel to test and replac...

Page 9: ...ance on the BIS alone for intraoperative anesthetic management is not recommended As with any monitored parameter artifacts and poor signal quality may lead to inappropriate BIS values Potential artifacts may be caused by poor skin contact high impedance muscle activity or rigidity head and body motion sustained eye movements improper sensor placement and unusual or excessive electrical interferen...

Page 10: ...iii ...

Page 11: ...at may appear on the BIS VIEW Monitoring System appears at the end of this section 1 1 Warnings GROUND WIRE LEAKAGE CURRENT MUST BE CHECKED BY A QUALIFIED BIOMEDICAL ENGINEERING TECHNICIAN WHENEVER INSTRUMENT CASE IS OPENED EXPLOSION HAZARD DO NOT USE THE BIS VIEW SYSTEM IN A FLAMMABLE ATMOSPHERE OR WHERE CONCENTRATIONS OF FLAMMABLE ANESTHETICS MAY OCCUR ELECTRICAL SHOCK HAZARD DO NOT REMOVE MONIT...

Page 12: ...ULD NOT CONTACT OTHER CONDUCTIVE PARTS INCLUDING EARTH TO REDUCE THE HAZARD OF BURNS IN THE HIGH FREQUENCY SURGICAL NEUTRAL ELECTRODE CONNECTION THE SENSOR OR ELECTRODES SHOULD NOT BE LOCATED BETWEEN THE SURGICAL SITE AND THE ELECTRO SURGICAL UNIT RETURN ELECTRODE TO REDUCE THE HAZARD OF BURNS DURING USE OF BRAIN STIMULATING DEVICES e g TRANSCRANIAL ELECTRICAL MOTOR EVOKED POTENTIAL PLACE STIMULAT...

Page 13: ... A REDUCED LEVEL OF SAFETY OF THE RESULTING SYSTEM CONSIDERATION RELATING TO THE CHOICE SHALL INCLUDE USE OF THE ACCESSORY IN THE PATIENT VICINITY EVIDENCE THAT THE SAFETY CERTIFICATION OF THE ACCESSORY HAS BEEN PERFORMED IN ACCORDANCE TO THE APPROPRIATE IEC 60601 1 AND OR IEC 60601 2 26 HARMONIZED NATIONAL STANDARD POWER SUPPLY IS INTERNALLY FUSED REPLACE POWER SUPPLY ONLY WITH ASPECT MEDICAL SYS...

Page 14: ...in accordance with the national laws of the country Contact Aspect Medical Systems Inc or the local distributor for a replacement battery P N 186 0208 All repairs to the BIS VIEW Monitoring System should be made only by a qualified Biomedical Engineering Technician or other authorized personnel Use only the parts and tools specified Use of any others may damage the instrument Using accessories oth...

Page 15: ...he exposed contacts of either connector Damage due to electrostatic discharge may result All work involving opening the instrument case must be performed in a static safe environment to prevent damage to electronic components and assemblies This environment includes the operator work area and tools and any other test or storage items that might touch the monitor or BISx assemblies Exposed metal pa...

Page 16: ...andby Mode Do not Reuse Use by YYYY MM DD or YYYY MM Latex free product PVC free product Manufacturer Date of Manufacture EC REP Authorized Representative in the European Community Catalog Number Batch Code Serial Number Conformité Européenne CE Marking of Conformity to European Medical Device Directive CEXXXX represents the Notified Body number Classified by Underwriters Laboratories Inc with res...

Page 17: ... Medical Systems International B V for a Return Materials Authorization RMA number or contact your municipality or the nearest collection site to dispose of waste equipment According to the WEEE Directive 2002 96 EC all waste electrical and electronic equipment EEE should be disposed of and collected separately and treated according to the best available and environmentally friendly techniques EEE...

Page 18: ..._______ 1 8 Operating on Battery No Battery is Installed in Monitor Ringing Bell Icon High Priority Alarm Condition exists The alarm sounds unless the alarm key has been pressed to silence it Yellow Bell with dotted X Alarms Paused Red Bell with X Alarms Silenced Figure 1 Symbol Key page 3 of 3 ...

Page 19: ...IS which correlates to the patient s level of hypnosis It operates from an AC power source of 100V to 240V 50 60Hz and provides approximately 45 minutes of automatic back up battery power The monitor is menu driven A detailed description of how the BIS VIEW Monitoring System works is included in the BIS VIEW Operating Manual Please refer to the BIS VIEW Operating Manual for additional information ...

Page 20: ...sed to make all selections These keys are designed to function even when the user is wearing examination gloves Alarm Key The Alarm Key is used to pause silence or reinstate audible alarms ON Standby button The ON Standby button is located in the lower right corner of the monitor and is used to put the monitor in ON or in Standby mode When the small LED light to the right of the ON Standby button ...

Page 21: ...n Figure 3 They include two USB ports Type A and B the clamp shoe an RS 232 port the Reset button the Battery Power Supply cover and the power cord receptacle The clamp shoe allows the monitor to slide into the pole clamp so that it can be attached to a 1 diameter vertical pole Clamp Shoe Serial Port USB Port Type A USB Port Type B Reset Button Battery Power Supply Cover Power Cord Receptacle ...

Page 22: ...e attachment clip on the BISx is used to secure it in a convenient location near the patient s head 2 3 Instrument Identification BIS VIEW Monitor Monitor identification information is permanently marked on the rear panel This information includes instrument model and serial numbers power ratings cautions and the Aspect Medical Systems shipping address BISx The BISx identification information is p...

Page 23: ...and Devices Information and descriptions contained in this guide are the property of Aspect Medical Systems and may not be copied reproduced or distributed without prior written permission Portions of the BIS VIEW Monitoring System design are proprietary and are the subject of patents and patents pending See the BIS VIEW Operating Manual for details ...

Page 24: ...SECTION 2 BIS VIEW MONITORING SYSTEM OVERVIEW _______________________________________________________________________ 2 6 ...

Page 25: ...gital signal processing techniques then sends the data to the monitor for display The purpose of processing the EEG waveform data is to extract characteristic features from the complex signal in order to provide easier pattern recognition of changes over time during the recording 3 2 System Architecture Hardware is divided into three main components the monitor the BISx and the Patient Interface C...

Page 26: ... USB Host J2 USB Client J3 Serial Port J4 DIGITIZER BOARD PROCESSOR BOARD BISx P102 P103 Patient P101 P100 J301 J300 CONNECTOR BOARD J1 J12 BATTERY ON STANDBY SWITCH SPEAKER DISPLAY INTERFACE BOARD POWER SUPPLY MOTHER BOARD BIS VIEW MONITOR Bulk head AC Power DISPLAY SOFT KEYS BISx Connector J103 J11 J8 J1 J2 J10 J7 J9 CARD ENGINE J4A J4B J4C P4A P4B P4C J100 J102 J101 ...

Page 27: ... to the Digital Signal Processor DSP The DSP filters the signals and computes the processed variables The results are passed to the monitor for display 3 2 1 The BISx The BISx contains the inputs amplifiers and digitizers for two channels of EEG and contains the circuits to digitally process the EEG data and compute the processed parameters It has a single point connection that connects via a Pati...

Page 28: ...ed into each electrode at 128 Hz just above the EEG band The resulting voltages are measured Equal but opposite currents are injected into the and electrodes simultaneously while the digital signal processor measures the resulting voltage BIS monitoring is performed while combined impedance is checked The BISx measures the individual electrode impedance during a sensor check by injecting current i...

Page 29: ...itiated when the BISx detects the presence of the smart chip After the data is read it is discontinued during the monitoring process to prevent interference with the EEG signal If the current exceeds 25 mA it is assumed there is something wrong with the smart chip and power to the chip is switched off Cautery Detector The cautery detector detects the common mode current passing through the sensor ...

Page 30: ... processed parameters from the BISx to display the data on the screen and to communicate with other devices via USB and RS 232 ports The monitor also contains the circuits for powering the monitor and the BISx An on board annunciator generates alarm sounds A block diagram depicting the monitor subassemblies appears in Figure 5 A data flow diagram appears in Figure 6 The signals are acquired digiti...

Page 31: ...Hz with output of 12 VDC 24 watt maximum It charges the battery 7 2 V nominal 2150 mA hr The power supply contains internal fuses that are not user accessible Signals from the motherboard are provided to the processor to indicate A C or battery powered and low battery Caution To turn off all A C power disconnect power cord from A C outlet Battery can be removed to shut down unit completely 3 2 2 4...

Page 32: ...PIC It checks to make certain that a valid unexpired sensor is in use 3 3 1 5 Impedance Check Sensor Check Electrode impedance is tested when the BISx PIC and sensor are connected and is monitored continuously unless the user has turned impedance checking off in the menu system Caution Continuous impedance checking may need to be disabled if the 1 nanoampere 128 Hz impedance check signal interfere...

Page 33: ...s that have been set up and then saved using the SAVE ACTIVE selection from the Settings menu Note The SAVE ACTIVE option is disabled when in Battery Backup Low Power condition The following settings are not saved by the SAVE ACTIVE option Impedance Checking always returns to ON Diagnostics Codes returns to OFF To restore factory settings go to MENU Maintenance Default Settings and press Restore 3...

Page 34: ...over for contact information WARNINGS THE USE OF ACCESSORY EQUIPMENT NOT COMPLYING WITH THE EQUIVALENT SAFETY REQUIREMENTS OF THIS EQUIPMENT MAY LEAD TO A REDUCED LEVEL OF SAFETY OF THE RESULTING SYSTEM CONSIDERATION RELATING TO THE CHOICE SHALL INCLUDE USE OF THE ACCESSORY IN THE PATIENT VICINITY EVIDENCE THAT THE SAFETY CERTIFICATION OF THE ACCESSORY HAS BEEN PERFORMED IN ACCORDANCE TO THE APPRO...

Page 35: ...0 feet below sea level to 360mm Hg 20 000 feet above sea level Protect the monitor from sudden temperature changes that can lead to condensation within the instrument To minimize condensation avoid moving the system 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 ...

Page 36: ...ACTURER NEVER ADAPT THE PLUG FROM THE MONITOR TO FIT A NON STANDARD OUTLET U S A REQUIREMENT 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 SLOT OUTLET IF THE OUTLET HAS ONLY TWO SLOTS MAKE SURE THAT IT IS REPLACED WITH A THREE SLOT GROUNDED OUTLET BEFORE ATTEMPTING TO...

Page 37: ...ide monitor down to fit The bottom of the clamp shoe should be seen well below the bottom of the pole clamp and the monitor should snap securely into place Figure 7 Pole Clamp To remove the monitor press tab on top of clamp shoe before sliding monitor up The pole clamp may be locked onto the monitor so that the two do not get separated To do this 1 Line up the clamp shoe on back of monitor with th...

Page 38: ... and pull DO NOT pull or twist the cable 2 Connect the PIC to the BISx Turn the 10 pin connector of the PIC so that the BIS logo is facing up then plug it into the BISx Note Once connected the PIC need not be disconnected again however if you wish to disconnect the PIC grasp the connector housing and pull firmly DO NOT twist or pull apart by the cable wire 4 2 2 Power Cord Connections The BIS VIEW...

Page 39: ...fy next screen says Connect BISx 4 Connect BISx to monitor Connect PIC and sensor to BISx Verify screen says BISx Initialization Complete Verify SENSOR CHECK begins 5 Disconnect power cord from rear of monitor Verify OPERATING ON BATTERY BACKUP is displayed Verify battery icon displays below BIS number 6 Reconnect power cord Verify battery icon is not displayed below BIS number Verify OPERATING ON...

Page 40: ...SECTION 4 PREPARATION FOR USE AND INSTALLATION _______________________________________________________________________ 4 6 ...

Page 41: ...the towel with detergent and lukewarm water to aid in cleaning After cleaning wipe the PIC connector ends with alcohol and allow to dry completely Residual moisture inside the connector may affect BISx performance 5 1 2 Disinfecting the Monitor and BISx Use lint free absorbent towels dampened with a 10 bleach solution or a commercial disinfectant e g Lysol Professional Disinfectant Foam Cleaner Sp...

Page 42: ...ts Avoid liquid ingress to the Patient Interface Cable Contact of fluids with the PIC sensor connectors can interfere with PIC performance 5 1 3 Cleaning the Monitor Display Clean the monitor display screen with a mild solution of detergent and warm water or a commercial display screen cleaner available through personal computer dealers To avoid scratching the screen never use abrasive cleaners ...

Page 43: ... joining surfaces to insure the integrity of the splash resistance seal 3 Inspect the cables and strain relief mechanisms 4 Inspect the connectors for damage faulty strain relief or contamination 6 2 Replacing the PIC Patient Interface Cable The Patient Interface Cable also known as the PIC cable is considered a consumable part of the system and is expected to wear out due to normal usage The inte...

Page 44: ...the monitor 2 Connect power cord to monitor Plug power plug into appropriate wall outlet Verify that the light to the right of the ON Standby button is yellow 3 Start up monitor by pressing the ON Standby button lower right corner Verify that the light to the right of the ON Standby button is green Verify all self tests complete successfully A beep tone sounds Verify next screen says Connect BISx ...

Page 45: ...ge and verification that the BISx will pass the DSC Self Test Begin this procedure with the system components disconnected The successful completion of this test verifies that the BISx circuits are functioning properly and that it is recognized by and communicates with the monitor IF ANY FAILURES ARE NOTED SEE SECTION 7 3 BIS VIEW System Messages And Corrective Actions 1 Using a known good BIS VIE...

Page 46: ...e and a known good BISx see section 6 3 2 BISx Checkout Procedure connect the PIC that you are testing to the BISx and connect the BISx to the BIS VIEW monitor 2 Press the monitor s ON Standby button to start up the monitor and BISx At the completion of the power up self test verify that the screen message Connect sensor or cable displays 3 Connect a Sensor Simulator see Section 10 2 or Test Senso...

Page 47: ...by pressing the SENSOR CHECK soft key The Sensor Check Graphic Screen displays During the test sequence flex the cable and connections at the PIC SENSOR and PIC BISx connections Note that gentle flexing of these cables and connectors should not cause the Sensor Check to fail NOTE Sensor Check is used in clinical application as an indicator of the patient s skin conductivity When used with a Sensor...

Page 48: ...ER IS CONNECTED TO MONITOR LEAKAGE CURRENT MUST BE CHECKED BY A QUALIFIED BIOMEDICAL ENGINEERING TECHNICIAN WHENEVER INSTRUMENT CASE IS OPENED Caution Check the battery periodically by operating a BIS VIEW monitor that has been disconnected from the wall socket and that has been charged to full capacity at least 6 hours of charge time After long periods of storage charge the battery for 6 hours to...

Page 49: ...NT SUCH AS SPILLAGE OF BLOOD OR SOLUTIONS OCCURS RE TEST BEFORE FURTHER USE Leakage Current testing should be performed by a qualified Biomedical Engineering Technician or authorized personnel only The BIS VIEW Monitoring unit does not contain a Protective Earth Stud GND Stud Since the exposed metal parts on the rear of the BIS VIEW Monitor Communication serial port and USB ports are separated fro...

Page 50: ...the PIC To check BISx patient isolation 1 Connect the Sensor Simulator to the PIC in place of a sensor See Appendix 2 Use a jumper to short the two terminals at the end of the simulator 3 Connect the test lead to the shorted terminals Make sure that you are not touching the simulator beyond this point 4 Proceed to test instrument for leakage current as per established facility protocols and proced...

Page 51: ...ostics run automatically the first time the unit is powered on after the battery or power supply have been replaced or after the Reset button has been pressed Software image checksums and trend data memory are tested and repaired if necessary The automatic diagnostics run continuously in the background while the unit operates These procedures check the BISx for the following conditions interface f...

Page 52: ...c troubleshooting information necessary for qualified technical personnel to test and replace those parts of the equipment that are replaceable by the customer Aspect does not authorize nor provide information to service or repair the internal electronic components of the BISx or the BIS VIEW monitor The qualified user may replace the BISx cables by following the procedures in Section 8 Servicing ...

Page 53: ...ognized the Monitor cable is likely suspect This failure may also be related to a PCB problem in the BISx in which case the BISx must be replaced If test indicates PASS continue to step 2 2 Connect Sensor Simulator or Test Simulator Run Sensor Check see Section 7 2 3 PIC Checkout Procedure If failure is noted swap PIC with known good PIC cable and run again If failure repeats the BISx or the BISx ...

Page 54: ...onnect equipment or press keys during this time 2 If several minutes have passed restart monitor 3 Reset monitor 4 Replace monitor Connect BISx 1 BISx disconnected 2 Defective BISx cable 3 Defective BISx 4 Defective monitor 1 Connect BISx Verify all cable connections 2 Replace Monitor Interface Cable 3 Replace the BISx 4 Replace monitor Re prep Sensor 0013 1 Sensor is not fully in contact with pat...

Page 55: ... Sensor Check Failed 0016 1 At least one element of sensor has too high impedance and EXIT pressed before sensor check completes 2 Poor sensor connection 3 Incorrect sensor application 4 Defective PIC 5 Defective BISx 1 Verify Sensor Check passes 2 Check sensor connection 3 Read Instructions on sensor package and re apply sensor 4 Replace the PIC 5 Replace BISx Bulkhead Connector or replace BISx U...

Page 56: ...n 2 EMG Bar indicates electrical activity that may be interfering with EEG recognition 3 PIC is defective 4 BISx is defective Note This message may occur as a result of artifact non EEG signal such as those generated from motion patient movement or eye blinks or the presence of electro cautery warming blankets or other devices 1 If ARTIFACT label appears above the EEG waveform box attempt to ident...

Page 57: ... that may be interfering with EEG recognition 3 PIC is defective 4 BISx is defective Note This message may occur as a result of artifact non EEG signal such as those generated from motion patient movement or eye blinks or the presence of electro cautery warming blankets or other devices 1 If ARTIFACT label appears above the EEG waveform box attempt to identify and eliminate artifact source 2 If EM...

Page 58: ...itor is running on the battery The battery keeps the monitor operating for approximately 45 minutes when the battery is fully charged 1 Restore the AC power 2 Verify power cord 3 Replace power supply Battery Voltage Low 0034 There are only a few minutes of battery life left Restore AC power to avoid automatic shutdown Sensor Negative Ground Fault 0092 Sensor Positive Ground Fault 0093 Problem is d...

Page 59: ...ugged during upgrade or battery ran out unexpectedly and software did not have time to detect it check error log for low battery entries 1 Unplug BISx and power cord and turn monitor off 2 Reconnect AC power and restart monitor 3 Press the reset button 4 If error persists replace monitor Data export error 512 See Message 3000 Date and time not changed 513 A case was in progress when the time date ...

Page 60: ...ve full 540 1 Removable drive is not connected properly to USB A port 2 Drive write protect is locked 3 Drive is incompatible or defective 4 Drive is full 1 Check connection 2 Verify write protect switch on the drive is set to unlock position 3 Replace drive Contact your Aspect Technical Service representative for a list of compatible drives 4 Replace drive Export halted BISx not detected 541 1 BI...

Page 61: ...ny 2 Turn the monitor off then on again 3 Reset monitor 4 Replace monitor Data Export Error 3000 3999 The data export was not successful 1 Removable drive is not connected properly to USB A port 2 Drive write protect is locked 3 Drive is not formatted properly 4 Drive is incompatible or defective 5 Drive is full 5 Make sure the removable drive is connected properly to the USB A port 6 Verify that ...

Page 62: ...SECTION 7 DIAGNOSTICS AND TROUBLESHOOTING ________________________________________________________________________ 7 12 ...

Page 63: ...place the PIC unplug the PIC cable from the BISx Bulkhead Connector by grasping the connectors NOT the cable and firmly pulling the two sections apart DO NOT twist or pull apart by the cable wire To attach the replacement PIC cable to the BISx align and press the PIC and BISx connectors together firmly 8 2 Replacing the BISx Parts Required Tools Required BISx with Patient Interface Cable P N 185 0...

Page 64: ... from the front of the monitor To do this grasp the connector on the BISx Monitor Interface Cable and pull DO NOT twist or pull on the cable 4 If necessary dismount monitor from pole clamp by removing set screw from clamp then depressing top of clamp shoe blue plastic clip at top of aluminum pole clamp and slide the monitor up and off of the clamp 5 To install the replacement monitor insert power ...

Page 65: ... Follow the instructions below 1 Unplug A C line cord from the monitor 2 Lay monitor screen side down on a scratch free work surface so that the Battery Power Supply cover is accessible 3 Remove 4 screws from the Battery Power Supply cover and remove the cover Note the position of the battery cable 4 Squeeze the battery connector latch to disengage it from the back of the monitor and remove the ol...

Page 66: ...plug A C line cord from the BIS VIEW monitor 2 Lay the monitor screen side down on a scratch free work surface so that the Battery Power Supply cover is accessible 3 Remove 4 screws from the Battery Power Supply cover and remove the cover The power supply is located inside the cover 4 Unplug squeeze and pull to remove the battery and the power supply connectors 5 Remove screws from the power suppl...

Page 67: ... screws from the Battery Power Supply cover and remove the cover The power supply is located inside the cover 4 Unplug squeeze and pull to remove the power supply connector 5 Remove screws from the power supply bracket and remove the power supply 6 Remove the three screws that attach the Clamp Shoe to the back panel 7 Replace the Clamp Shoe and attach it to the back panel with the three new screws...

Page 68: ...he parts and tools specified Use of any others may damage the instrument 8 7 1 Parts and Tools Required Parts Required Tools Required BISx Monitor Cable Replacement Kit P N 186 0201 AMS includes Torque screwdriver with Torx bit size T 7 BISx Monitor Interface Cable P N 175 0061 GA Gasket P N 150 0187 Torx head screws P N 606 0008 8 7 2 Procedure 1 Disconnect BISx from the monitor 2 Remove screws f...

Page 69: ...ERVICING THE BIS VIEW MONITORING SYSTEM 8 7 3 Open the ZIF connector by pulling away from the bulkhead 4 Disconnect from the flex cable Discard the old gasket 5 Set the new gasket in the groove of the BISx housing ...

Page 70: ... the flex cable from the BISx to the ZIF connector on the replacement cable 7 Ensure that the flex cable is fully inserted into the ZIF and close the ZIF connector by pushing toward the bulkhead Carefully feed the flex cable into the housing and seat the cable bulkhead to the BISx housing Key feature ZIF open ZIF closed ...

Page 71: ...ing System should be made only by a qualified Biomedical Engineering Technician or other authorized personnel Use only the parts and tools specified Use of any others may damage the instrument 8 8 1 Parts and Tools Required Parts Required Tools Required BISx Bulkhead Replacement Kit P N 186 0202 includes Torque screwdriver with Torx bit size T 7 BISx Bulkhead P N 175 0052 Gasket P N 150 0187 Torx ...

Page 72: ...MONITORING SYSTEM 8 10 8 8 2 Procedure 1 Disconnect BISx from the monitor and remove Patient Interface Cable from BISx 2 Remove screws from the bulkhead Discard screws 3 Open the ZIF connector by pulling away from the bulkhead ZIF open ...

Page 73: ...SECTION 8 SERVICING THE BIS VIEW MONITORING SYSTEM 8 11 4 Disconnect from the flex cable Discard the old gasket 5 Set the new gasket in the groove of the BISx housing ...

Page 74: ...ch the flex cable from the BISx to the ZIF connector on the replacement bulkhead 7 Ensure that the flex cable is fully inserted into the ZIF and close the ZIF connector by pushing toward the bulkhead Carefully feed the flex cable into the housing and seat the bulkhead to the BISx housing Key feature ZIF open ZIF closed ...

Page 75: ...2 The BISx Checkout Procedure or refer to the BIS VIEW Monitoring System Operating Manual 2 Verify that all test sections PASS 3 Install a known good PIC cable 4 Connect a Sensor Simulator or Test Sensor tool as described in Section 10 Appendix I 5 Perform a Patient Interface Cable PIC Checkout Procedure as described in Section 6 3 3 PIC Checkout Procedure For more detail refer to the BIS VIEW Mon...

Page 76: ...ngs for instructions 2 Power the monitor down completely by unplugging the power cord and then pressing the ON Standby button until the light on the right side of the button goes out 3 Re connect the power cord to AC power then press the ON Standby button to start up the monitor The light should be green 4 Insert the USB drive containing the software update into the USB port Type A at the rear of ...

Page 77: ...Service phone number is printed on the back cover of this manual The RMA number must appear on the outside of the shipping container Use the original shipping container if available or equivalent packaging to protect the product Seal the package with reinforced packing tape rather than plastic or masking tape Mark shipping or storage container FRAGILE If the repair or replacement is covered by war...

Page 78: ...SECTION 8 SERVICING THE BIS VIEW MONITORING SYSTEM 8 16 ...

Page 79: ...toring System General Specifications Product Description BIS Bispectral Index monitoring system for display of processed data and real time EEG waveforms Monitor Weight 2 65 lbs 1 2 kg Monitor Dimensions 6 in wide x 6 5 in high x 5 in deep 15 2 cm x 16 5 cm x 12 7 cm Display Size 3 6 in 9 1 cm Digital Output USB ports A B RS232 serial port Power Requirements 100 240 VAC 50 60 Hz 0 7 ampere max Ele...

Page 80: ...tomatic Input Amplifier Range 1 mV EEG Scales One Channel Display 25 μV div 50 μV full scale EEG Sweep Speed 25 mm sec Computed Parameters Bispectral Index EMG SR and Signal Quality Indicator User defined Displays Trend and real time EEG waveforms Update Rate 1 second for BIS number 10 seconds for Trend Alarms Auditory and visual user adjustable limits Filters 2 70 Hz with notch ...

Page 81: ...ter x 2 5 in thick 9 5 cm x 6 3 cm 9 ft 2 7 m Integral BISx Cable 4 ft 1 4 m from BISx to sensor connector Analog to Digital Converter Noise shaped sigma delta Sampling Rate 16 384 samples second Resolution 16 Bits at 256 samples second Input Impedance 50 Mohms typical Noise 0 3 μV RMS 2 0 μV peak to peak 0 25 Hz to 50 Hz Common Mode Rejection Isolation mode 110 dB at 50 60 Hz to earth ground Freq...

Page 82: ...t electric shock regarding allowable leakage currents and reliability of the protective earth ground connection with an F type applied part An F type applied part 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 rated AC supply voltage is applied betw...

Page 83: ...al 9 2 1 Accessories The BIS VIEW Monitoring System complies with the requirements of IEC 60601 1 2 2001 when used with the accessories listed in Section 2 of the Operating Manual In addition the BIS VIEW system must be used only with the power cord provided When using the Software Upgrade Device to load new versions of software into the BIS VIEW monitor no cables or other accessories should be co...

Page 84: ...e RF Emissions CISPR 11 Group 1 The BIS VIEW Monitoring System uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF Emissions CISPR 11 Class A Harmonic Emissions IEC 61000 3 2 Class A Voltage Fluctuations Flicker Emissions IEC 61000 3 3 Complies The BIS VIEW Monitoring System is suitable...

Page 85: ...spital environment Surge IEC 61000 4 5 1 kV differential mode 2 kV common mode 1 kV differential mode 2 kV common mode Mains power quality should be that of a typical hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 5 UT 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in U...

Page 86: ...d mobile RF communications equipment should be used no closer to any part of the BIS VIEW system including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance d 1 2 d 1 2 80 MHz to 800 MHz d 2 3 800 MHz to 2 5 GHz where P is the maximum output power rating of the transmitter in watts according t...

Page 87: ... FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the BIS VIEW system is used exceeds the applicable RF compliance level above the BIS VIEW system should be observed to verify normal ope...

Page 88: ...communications equipment Rated maximum output power of equipment W Separation distance according to frequency of transmitter m 150 kHz to 80 MHz d 1 2 80 MHz to 800 MHz d 1 2 800 MHz to 2 5 GHz d 2 3 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can...

Page 89: ...hereof If Aspect reasonably determines that a repair or replacement is covered by the warranty Aspect shall bear the costs of shipping the repaired or replacement Product to Purchaser All other shipping costs shall be paid by Purchaser Risk of loss or damage during shipments under this warranty shall be borne by the party shipping the Product Products shipped by Purchaser under this warranty shall...

Page 90: ...ULAR PURPOSE ASPECT S MAXIMUM LIABILITY ARISING OUT OF THE SALE OF THE PRODUCTS OR THEIR USE WHETHER BASED ON WARRANTY CONTRACT TORT OR OTHERWISE SHALL NOT EXCEED THE ACTUAL PAYMENTS RECEIVED BY ASPECT IN CONNECTION THEREWITH ASPECT SHALL NOT BE LIABLE FOR ANY INCIDENTAL SPECIAL OR CONSEQUENTIAL LOSS DAMAGE OR EXPENSE INCLUDING WITHOUT LIMITATION LOST PROFITS DIRECTLY OR INDIRECTLY ARISING FROM TH...

Page 91: ... 0104 BIS Sensor Dispenser 186 0137 Sensor Simulator PARTS 186 0208 Battery Replacement Kit 186 0216 Power Supply Replacement Kit 186 0217 Shoe Clamp Replacement Kit 186 0201 AMS BISx Host Cable Monitor Cable Replacement Kit 186 0202 BISx Bulkhead Replacement Kit 186 1003 Battery Power Supply Cover Assembly with Shoe Clamp 150 0272 Handle VIEW monitor 675 0022 Cable wrap Blue hook loop MISCELLANEO...

Page 92: ... test equipment to the monitor via the patient interface cable PIC Figure 8 Schematic of the BIS Sensor Simulator Schematic of the 2CH 4CH BIS Sensor Simulator circuitry IO3 IO6 connect to 4 input signal pins on a 2 channel patient interface cable IO1 IO6 connect to 6 input signal pins on a 4 channel patient interface cable The Inputs and are where one connects the test signals to test the BIS Mon...

Page 93: ... jumpers or alligator clips Connect the test signal to the shorted terminals Make sure that you are not touching the BIS Sensor Simulator beyond this point Proceed to test instrument for Leakage current as per established facility protocols and procedure for safety testing of medical devices Simulator Cleaning Wipe simulator surfaces with a wet cloth soaked in lukewarm tap water containing bleach ...

Page 94: ...per clip at the midpoint of electrode 2 then lay it across electrode 4 See Figure 11 Figure 11 Connecting electrodes 2 and 4 3 Fold electrode 3 over onto electrode 4 pressing adhesive surfaces together and making sure the paper clip remains in place 4 Fold electrode 1 over onto electrode 2 Figure 12 Connecting electrode 3 with 4 and 1 with 2 1 2 4 3 ...

Page 95: ... PIC All impedance tests should complete successfully with low impedance values Typical values using this alternative Test Sensor are less than 5 K ohms The following chart shows expected Test Sensor values Test Sensor Values Electrode Typical Range 1 1 K ohm 1 2 K ohms 2 1 K ohm 1 3 K ohms 4 1 K ohm 1 2 K ohms 3 1 K ohm 1 2 K ohms ...

Page 96: ...IC Patient Interface Cable sensor cable to other end of BISx 3 Verify sensor for test is of current date code Connect sensor to PIC cable 4 Remove gel and green pad from each sensor contact point 5 Connect safety tester leads per tester instructions to sensor contact point pads i e via alligator clips 6 Apply power to the BIS VIEW system per safety tester instructions Make required leakage measure...

Page 97: ...______ 11 1 11 APPENDIX II 11 1 Data Flow Diagram Patient Connection BISx Input Protection Amplification and Filtering Sigma Delta Modulators FPGA Digital Signal Processor DSP Serial Comm Key switch Serial Comm Color Display Host Processor USB Host Port RS 232 Port BIS VIEW Monitor ...

Page 98: ...Client J3 Serial Port J4 DIGITIZER BOARD PROCESSOR BOARD BISx P102 P103 Patient P101 P100 J301 J300 CONNECTOR BOARD J1 J12 BATTERY ON STANDBY SWITCH SPEAKER DISPLAY INTERFACE BOARD POWER SUPPLY MOTHER BOARD BIS VIEW MONITOR Bulk head AC Power DISPLAY SOFT KEYS BISx Connector J103 J11 J8 J1 J2 J10 J7 J9 CARD ENGINE J4A J4B J4C P4A P4B P4C J100 J102 J101 ...

Page 99: ......

Page 100: ...ce 888 BIS INDE X press 6 or 800 442 7688 press 6 Technical Service 800 442 2051 Email bis_info aspectms com Web www aspectmedical com Service Information www aspectmedical com ASRS EC REP Aspect Medical Systems International B V Rijnzathe 7d2 3454 PV De Meern The Netherlands Main Business Phone 31 30 662 9140 Main Business Fax 31 30 662 9150 Email amsint aspectms com ...

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