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A-10

Patient Data Module

2030047-001A

Appendix A–Technical Specifications

Cardiac output

Certifications

Method:

Thermodilution

Parameters Displayed:

Cardiac output, blood temperature, injectate temperature,
real-time cardiac output washout curve, last average CO

Cardiac output range:

0.2 to 15 liters per minute

Blood temperature range:

17°C to 42°C (62°F to 107°F)

Blood temperature
accuracy:

±0.5°C 17°C to 30°C

Injectate temperature
range:

0°C to 30°C (32°F to 86°F)

Injectate temperature
accuracy:

±0.3°C

Cardiac output review:

Accept/reject individual measurements and store average

Catheter sizes:

5, 6, 7, 7.5, or 8 French

Injuectate volume
selections:

3, 5, or 10

IEC/EN/UL 60601-1

CAN/CSA C22.2 No. 601.1

IEC/EN 60601-1-2

IEC/EN 60601-2-27

IEC/EN 60601-2-30

IEC/EN 60601-2-34

IEC/EN 60601-2-49

IEC/EN 60601-2-51

EN 12470-4

EN ISO 9919

ANSI/AAMI SP10

ANSI/AAMI EC11

ANSI/AAMI EC13

CE Marking: Medical Devices Directive - 93/42/EEC

JJG 760

YY 91079

Содержание PDM

Страница 1: ...GE Healthcare Patient Data Module English 2030048 001 cd 2030046 001A paper 2007 General Electric Company All rights reserved Patient Data Module PDM Service Manual Software version 1 ...

Страница 2: ...ll other trademarks contained herein are the property of their respective owners UNITY NETWORK DASH SOLAR TRAM and TRIM KNOB are trademarks of GE Medical Systems Information Technologies registered in the United States Patent and Trademark Office CARESCAPE is a trademark of GE Medical Systems Information Technologies For technical documentation purposes the abbreviation GE is used for the legal en...

Страница 3: ...ds 1 4 Equipment symbols 1 4 Service information 1 5 Service requirements 1 5 Equipment Identification 1 6 2 Equipment Overview 2 1 Overview 2 2 Front view 2 2 Rear view 2 3 Side view 2 3 Controls 2 4 Indicators 2 4 Connector 2 4 Basic components 2 5 Battery 2 5 Patient Data Module ePort host interface cable 2 5 Docking stations 2 5 Theory of operation 2 7 Overview 2 7 3 Installation 3 1 Battery 3...

Страница 4: ...ce tool modules 4 7 Device Information 4 7 Configuration 4 8 Diagnostics 4 10 Calibration 4 10 5 Maintenance 5 1 Maintenance schedule 5 2 Manufacturer recommendations 5 2 Manufacturer responsibility 5 2 Inspection 5 2 Cleaning 5 3 Precautions 5 3 Cleaning procedures 5 3 Storage 5 4 Consequences of using improper cleaning product 5 4 Cleaning products to avoid 5 4 Expansion interface cleaning 5 5 B...

Страница 5: ...ostatic discharge ESD precautions 7 3 Replacement procedures 7 4 Battery 7 4 Labels 7 5 Battery door and tray 7 6 Mount rail and pull tab 7 7 Top housing 7 9 Main board 7 11 NBP hose coupling and elbow 7 12 NBP assembly with manifold hose 7 12 A Appendix A Technical Specifications A 1 Technical Specifications A 2 Physical A 2 Environmental A 2 Battery A 2 ECG A 3 Respiration A 5 Temperature A 5 In...

Страница 6: ...Compatibility B 1 Electromagnetic compatibility EMC B 2 Guidance and manufacturer s declaration electromagnetic emissions B 2 Guidance and manufacturer s declaration electromagnetic immunity B 3 Recommended separation distances B 4 Compliant cables and accessories B 5 ...

Страница 7: ...2030047 001A Patient Data Module 1 1 1 Introduction ...

Страница 8: ...r copy of this manual will be provided upon request Contact your local GE representative and request the part number on the first page of the manual Safety information Responsibility of the manufacturer GE is responsible for the effects of safety reliability and performance only if Assembly operations extensions readjustments modifications or repairs are carried out by persons authorized by GE The...

Страница 9: ...ce that the safety certification of the accessory has been performed in accordance to the appropriate IEC 60601 1 and or IEC 60601 1 1 harmonized national standard If the installation of the equipment in the USA will use 240V rather than 120V the source must be a center tapped 240V single phase circuit Hazard definitions Warnings and Cautions are used throughout this manual and designate a degree ...

Страница 10: ...nt is specifically designed for applications intentional external and internal application to the patient excluding direct cardiac application Type BF equipment is type B equipment with an F type isolated floating part The paddles indicate the equipment is defibrillator proof Medical Equipment With respect to electric shock fire and mechanical hazards only in accordance with UL 60601 1 CAN CSA C22...

Страница 11: ...the need for service to GE Medical Systems Information Technologies or to one of their authorized agents Failure on the part of the responsible individual hospital or institution using this equipment to implement a satisfactory maintenance schedule may cause undue equipment failure and possible health hazards Regular maintenance irrespective of usage is essential to ensure that the equipment is al...

Страница 12: ...s a unique serial number for identification A sample of the information found on a serial number label is shown below Description 1 Product code1 1 Product code for the Patient Data Module is SA3 2 Year manufactured 3 Fiscal week manufactured 4 Production sequence number 5 Manufacturing site 6 Miscellaneous characteristic 1 2 3 4 5 6 ...

Страница 13: ...2030047 001A Patient Data Module 2 1 2 Equipment Overview ...

Страница 14: ...patient processes the patient data signals and stores a limited amount of patient data 24 hours captured at 1 minute resolution for seamless transport Front view 404B 1 Expansion cover expansion mount for future expansion modules 2 Communication icon and indicator 3 Power icon and indicator 4 Power ON IBP Zero All button 5 Patient cable connectors 6 Defib Sync for auxiliary equipment 2 1 3 5 6 4 ...

Страница 15: ...Equipment Overview 2030047 001A Patient Data Module 2 3 Rear view 405B Side view 406A 1 ePort host interface connection 2 Battery door 1 2 1 Expansion cover 2 Docking station 3 Pull tab 1 2 3 ...

Страница 16: ...r No light indicates no communication Solid amber indicates an application reset Solid green indicates communication Flashing amber indicates communication failure Alternately flashing with the power LED indicates software transfer Power The following LED condition identifies the power status No light indicates no power applied Solid amber indicates software booting up Solid green indicates powere...

Страница 17: ... Bedside dock for use with Solar 8000M i patient monitor Transport dock for use with Transport Pro patient monitor Fixed mount adapter mini dock for use with mounting hardware Patient Data Module bedside dock The Patient Data Module bedside dock is used for mounting the Patient Data Module to a bedside patient monitor It has a host interface connection which delivers power provides communication a...

Страница 18: ...2 6 Patient Data Module 2030047 001A Equipment Overview Views Patient Data Module bedside dock 480A Patient Data Module fixed mount adapter mini dock 481A ...

Страница 19: ...up information such as blood pressure zero points and alarm limit settings The patient history is stored so that the collected information is transferred when a patient is transferred to a different monitor 413B The Patient Data Module shares power and communicates with host devices through the host interface connection called the ePort The Patient Data Module connects directly to a transport pati...

Страница 20: ...2 8 Patient Data Module 2030047 001A Equipment Overview Up to four channels of invasive blood pressure and cardiac output or two channels of temperature Defibrillator sync analog out interface ...

Страница 21: ...2030047 001A Patient Data Module 3 1 3 Installation ...

Страница 22: ... capacity Three LEDs illuminated 50 74 9 of full charge capacity Two LEDs illuminated 25 49 9 of full charge capacity One LED illuminated 10 24 9 of full charge capacity One LED flashing 10 of full charge capacity remaining Install or change the battery 1 Open the battery door by gently pulling on the battery door pull tab 862A 2 Pull the battery tray out of the Patient Data Module using the batte...

Страница 23: ...are installed If you need to install the software contact your GE representative Mounting options WARNING For safety reasons all connectors for patient cables and sensor leads are designed to prevent inadvertent disconnection should someone pull on the leads Do not route cables in a way that they may present a stumbling hazard WARNING PHYSICAL INJURY Do not hang articles on the IV pole that are no...

Страница 24: ...7 001A Installation 482A Mounting options include mounting to a bed headboard or footboard an IV pole or a roll stand using one of the docking stations Mounting kits include all necessary hardware and installation instructions 483A ...

Страница 25: ...ort dock mounting rails 2 Slide the Patient Data Module toward the ePort until the locking key secures it to the transport dock Connect to bedside monitor If using the Patient Data Module with a bedside monitor 1 Connect one end of the ePort host interface cable to the Patient Data Module ePort connector 2 Connect the other end of the ePort host interface cable to the Solar to Patient Data Module ...

Страница 26: ...3 6 Patient Data Module 2030047 001A Installation ...

Страница 27: ...2030047 001A Patient Data Module 4 1 4 Service Tool and Configuration ...

Страница 28: ...tient Data Module using a Solar 8000M I patient monitor PC with Microsoft Windows XP or 2000 operating system a CD ROM drive and a network card Category 5 crossover cable 2028822 001 ePort to host interface cable 2017098 002 Solar 8000M i patient monitor with PDM service adapter 2028845 002 Patient Data Module software CD with GEHC MS Service Tool If servicing the Patient Data Module without a hos...

Страница 29: ...t to host interface cable between the ePort on the Patient Data Module and the ePort connector on the PDM service adapter 3 If the PDM service adapter is not connected to a Solar 8000M i patient monitor connect the external power supply to the PDM service adapter 4 Remove the Patient Data Module battery 5 Press the power button on the Patient Data Module 6 Power on the PC ePort to host cable cross...

Страница 30: ...s double click the service e g Black ICE and Security Accounts Manager to be disabled Windows XP Windows 2000 1 From the toolbar select Start Run 2 Type cmd and press Enter 3 Type ipconfig space all and press Enter 4 If the IP address and subnet mask are defined record them IP address _______________________________________ Subnet mask _________________________________________ 5 From the toolbar s...

Страница 31: ... Configuration 2030047 001A Patient Data Module 4 5 455A 3 In the specific service e g BlackICE and Security Accounts Manager properties window select Stop 456A 4 Verify that the Service status reads Stopped Click Stop ...

Страница 32: ...C contact your local IT administrator for details Windows 2000 and XP PC s allow you to send a list of services to your IT administrator Enter the Patient Data Module service tool 1 Properly connect and configure the Patient Data Module and service laptop as described in Set up the PC on page 4 2 2 Insert the Patient Data Module software CD in the CD ROM drive The GEHC MS Tool application opens au...

Страница 33: ...y updates in 30 second intervals The GEHC MS Service Tool provides a basic description of each module in the Help file From the toolbar in the module click Help Help Device Information The Device Information module displays general information about the Patient Data Module and calibration information It also displays the last date and times that NBP calibration analog out IP calibration and analog...

Страница 34: ...turer s serial number and the user assigned asset number 1 Enter the serial number and click Submit NOTE The manufacturer s serial number must follow the specific format found on the serial number label on the Patient Data Module The manufacturer s serial number must be edited if the main cpu board is replaced 464A 2 Enter the user assigned asset number and click Submit NOTE The user assigned asse...

Страница 35: ...MAC address See the How to Reach Us page included with this manual for contact information Enter the activation code and click Activate to complete the installation Click Remove to remove a license NOTE After installation perform the checkout procedures provided in the host patient monitor service manual A new activation code must be requested and entered if the main cpu board is replaced Software...

Страница 36: ...very 30 seconds After replacing the NBP pump assembly clear all NBP statistics and perform the checkout procedures provided in the host patient monitor service manual If a value in the Service Metrics module is out of specification the data field will be highlighted red Contact GE technical support See the How to Reach Us page included with this manual for contact information Calibration The Calib...

Страница 37: ... the following pins 5 Type in or use the scroll buttons to enter the measured voltage from the digital voltmeter 6 Click OK to confirm the measured voltage NOTE Perform calibration if the main cpu board is replaced After calibration perform the checkout procedures provided in the host patient monitor service manual Pin Wire color Signal name 1 Brown ECG_ANALOG_OUT 6 Green ANALOG_RETURN Pin Wire co...

Страница 38: ...4 12 Patient Data Module 2030047 001A Service Tool and Configuration ...

Страница 39: ...2030047 001A Patient Data Module 5 1 5 Maintenance ...

Страница 40: ... the use of this device to implement the recommended maintenance schedule may cause equipment failure and possible health hazards The manufacturer does not in any manner assume the responsibility for performing the recommended maintenance schedule unless an Equipment Maintenance Agreement exists The sole responsibility rests with the individuals hospitals or institutions utilizing the device Inspe...

Страница 41: ... these rules may melt distort or dull the finish of the case blur lettering on the labels or cause equipment failures 1 Remove power all cables and batteries 2 Close the battery door 3 Wipe the exterior with a soft lint free cloth using one of the following solutions recommended in the APIC Guidelines for Selection and Use of Disinfectants 1996 Sodium hypochlorite 5 2 household bleach minimum 1 50...

Страница 42: ... connected to a patient causing false alarms instead of a leads fail alarm and possibly not providing a visual or audible leads fail alarm Brittle and breaking device case Overall system performance degradation Melting dulling or distorting the case Total medical device failure requiring replacement Unit malfunction Void warranty Cleaning products to avoid Cleaning products known to cause the type...

Страница 43: ...the following solutions recommended in the APIC Guidelines for Selection and Use of Disinfectants 1996 Sodium hypochlorite 5 2 household bleach minimum 1 500 dilution minimum 100 ppm free chlorine and maximum 1 10 dilution Any sodium hypochlorite wipe product that meets the above guidelines NOTE Wring excess disinfectant from cloth before using Contact of disinfectant solutions with metal parts ma...

Страница 44: ...ause the unit to malfunction and void the warranty 1 Remove the battery from the battery compartment 2 Clean the device with a gauze pad or cloth lightly moistened with one of the following Water Soap 3 Use a cloth lightly moistened with distilled water to rinse away the cleaning solution Make sure moisture does not enter the electronics area below the battery compartment floor 4 Dry thoroughly wi...

Страница 45: ...pacity The actual amount of charge the battery can store and deliver Remaining charge capacity The amount of full charge capacity currently remaining in the battery This is a percent of full charge capacity Use recommendations GE recommends the following methods to improve battery performance Location Position the equipment in a location that does not artificially increase the operating temperatur...

Страница 46: ...th a Cadex Smart2 battery charger 1 Insert the battery into the battery charger The RUN LED lights 2 Leave the battery in the charger until the READY LED lights NOTE If the FAIL LED lights remove the battery from the battery charger and reinsert it This corrects any battery charger time out errors If the FAIL LED still lights replace the battery Charge inside the Patient Data Module The battery ch...

Страница 47: ...Battery Recycling Corporation RBRC can help locate your nearest rechargeable battery collection site Contact them by telephone 1 800 8 BATTERY 800 822 8837 internet www rbrc org Checkout procedures and NBP calibration GE recommends that qualified service personnel perform system checkout procedures including electrical safety tests parameter tests and NBP calibration found in the Solar 8000M i pat...

Страница 48: ...5 10 Patient Data Module 2030047 001A Maintenance ...

Страница 49: ...2030047 001A Patient Data Module 6 1 6 Troubleshooting ...

Страница 50: ...DM service adapter 2028845 002 PC with Microsoft Windows XP or 2000 operating system a CDROM drive and a network card Category 5 crossover cable 2028822 001 ePort to host interface cable 2017098 002 If troubleshooting the Patient Data Module without a host patient monitor PDM Service Tool Kit 2030924 001 Before you begin Before beginning any detailed troubleshooting complete a thorough visual insp...

Страница 51: ...ng replace the battery External surface is damaged Check the Patient Data Module s top housing as follows 1 Check for cracks or other damage to the top housing If damaged replace the top housing See chapter 7 Field Replaceable Units for ordering parts and replacement procedures 2 Check for cracks or other damage to the bottom housing If damaged contact GE technical support to service the Patient D...

Страница 52: ...al for contact information 3 Check for licensing using the GEHC MS service tool See chapter 4 Service Tool and Configuration Go to Configuration Licensing If license is not activated install the license s 4 Check that the patient monitor is configured to display the parameter Noisy waveforms missing markers or inaccurate patient data Check for ECG configuration filter using the GEHC MS service too...

Страница 53: ...rror messages display at the patient monitor if there is a serious problem with the Patient Data Module Error message Action COMMUNICATION FAILURE Go to See Problems and solutions on page 6 3 BATTERY FAIL Go to See Battery care on page 5 7 SERVICE THE PDM Contact GE technical support ...

Страница 54: ...6 6 Patient Data Module 2030047 001A Troubleshooting ...

Страница 55: ...2030047 001A Patient Data Module 7 1 7 Field Replaceable Units ...

Страница 56: ...ry door and tray 2031069 003 Battery 2031069 004 Patient Data Module mount rail and pull tab 2031069 005 Label kit Nellcor 2031069 006 Label kit Masimo 2031069 007 NBP assembly with MFLD hose 2031069 008 NBP MFLD hose coup elbow only 2031069 009 Top housing 2031069 010 Main cpu includes software CD 2031069 011 Expansion cover 2028783 001 Solar to Patient Data Module adapter 2017098 001 2017098 002...

Страница 57: ...mbly and assembly Wearing safety glasses is recommended Before disassembly Before disassembling the Patient Data Module always do the following Remove all cables Remove the battery Provide appropriate electrostatic discharge protection to prevent damaging the Patient Data Module See Electrostatic discharge ESD precautions below for details Hardware precautions Observe the following guidelines when...

Страница 58: ...ors or assemblies containing semiconductors from antistatic containers Velo stat bags until absolutely necessary Make sure power to an assembly is turned off before removing or inserting a semiconductor Do not slide semiconductors or electrical electronic assemblies across any surface Do not touch semiconductor leads unless absolutely necessary Semiconductors and electronic assemblies should be st...

Страница 59: ...URY Make sure the battery is completely inserted and that the battery door is securely sealed Falling batteries could seriously or fatally injure neonatal or other vulnerable patients 5 Press the Power button on the Patient Data Module 6 Verify that the Power LED illuminates amber while the Patient Data Module boots up then illuminates green 404B Power LED ...

Страница 60: ...as shown 404B 464A Battery door and tray 1 Remove 1 screw that holds the battery door to the housing and remove the door and washer 462A 2 Remove the battery if one is in the tray 3 Use a flathead screw driver to lift the catch tab on the tray as you pull it out of the housing screw ...

Страница 61: ...A Mount rail and pull tab 1 Remove 2 screws on the latch stop Remove the latch stop 463A 2 Grasp the pull tab between thumb and index finger as shown and gently pull it straight out about a half inch Lift the assembly out of the rail slot catch tab Latch stop screws ...

Страница 62: ...assembly comes apart when pulled from the rail slot reassemble as shown below 470A 471A 3 Remove 2 short screws at the rear of the mount rail and 2 long screws at the front of the mount rail 464A 4 Unseat the mount rail by twisting it slightly Lift mount rail off the top housing Long screws Short screws ...

Страница 63: ... rail and pull tab per above steps 2 Remove 4 machine screws that hold the top and bottom housing together 464A 3 Turn the Patient Data Module right side up and lift off the top housing 4 Install the top housing as follows a Inspect the gasket in the top housing to be sure it is securely placed in the groove 472A b Make sure the flex connector to the front panel board is connected securely Gasket ...

Страница 64: ... rear of the module position alignment pins of the top housing into the bottom housing holes then close the housing straight down 474A d Squeeze the top and bottom housings together to eliminate gaps Install the screw near the Power ON button first Front panel connector Alignment pins ...

Страница 65: ...ve the main board NOTE When installing the main board position it into the alignment pins See figures above and below fold the flex material over the top of the board and hold in place while installing screws 5 Load new software from the CD included in the Main board FRU kit Go to Software Transfer on page 4 9 for instructions 6 Calibrate analog out Go to Calibration on page 4 10 for instructions ...

Страница 66: ...e manufacturer s serial number 9 Go to the Solar 8000M i patient monitor service manual and complete checkout procedures NBP hose coupling and elbow 1 Remove the top housing and main board per above steps 2 Disconnect the front panel connector 477A 3 Disconnect the main board flex pump connector 4 Hold flex out of the way and disconnect the NBP hose from the coupling 5 Remove hose from the manifol...

Страница 67: ...NBP hose coupling and elbow per above steps 2 Remove 4 screws from the battery cover 467A 3 Grasp and slide the battery cover out to the rear 4 Remove 1 screw under the pump tube connection 466A 5 Lift off the manifold with pump 6 Remove the interface gasket Front panel board connector Main board flex pump connector Battery cover ...

Страница 68: ... housing and carefully press to seat connector d Install the screw then connect the hose Slide hose all the way onto the manifold fitting so that the hose lays flat e Make sure the pump is resting between the positioning protrusions 8 After replacing the NBP assembly with manifold use the GEHC MS service tool to clear all NBP statistics and perform the checkout procedures in the Solar 8000M i serv...

Страница 69: ...2030047 001A Patient Data Module A 1 A Appendix A Technical Specifications ...

Страница 70: ...al convection Operating heat dissipation 10 2 Btu Hr NOTE System may not meet its performance specifications if stored or used outside the manufacturer s specified temperature and humidity ranges Operating temperature and humidity 10º C to 35º C 50º F to 95º F 15 to 95 RH non condensing Storage temperature and humidity 40º C to 60º C 40º F to 140º F 15 to 95 RH non condensing Type Exchangeable lit...

Страница 71: ...A Input specifications QRS detection range Signal width Heart rate range Common mode rejection Gain accuracy Linearity deviation Noise 0 5 mV to 5 mV 40 ms to 120 ms Q to S 30 to 300 beats per minute 90 dB minimum at 60 Hz 5 diagnostic mode 5 30 μV referred to input Output specifications Frequency response Monitoring mode 0 05 to 100 Hz 0 05 to 40 Hz 0 05 to 25 Hz Diagnostic mode 0 05 to 150 Hz An...

Страница 72: ...iption ST segment deviation is measured and displayed for all acquired leads ST display Lead label ST deviation current complex superimposed over a reference complex J point indicator and 15 minute mini trends are shown for all acquired leads Measurement point Measured at user selectable measurement points 0 30 40 50 60 and 80 ms following the J point Measurement range Display resolution ST measur...

Страница 73: ... 4 to 10 Ohms impedance variation Respiration rate alarm range 1 to 200 breaths minute No breath alarm range 3 to 30 seconds Number of channels Up to 2 with Y adapter cable Input specifications Probe type Series 400 or 700 determined by input cable Temperature range 0 C to 45 C 32 F to 113 F Resolution 0 01 C internal Output specifications Parameters displayed T1 T2 Error independent of source 0 1...

Страница 74: ...ransducer requirements Transducers meeting the following specifications can be used however have not been evaluated by UL NOTE Note UL Classification covers the following invasive blood pressure transducers Utah Deltran IV CPT 400 Edwards PX600 Bekton Dikinson P23XL 1 Abbot 42582 08 Accuracy 2 or 1 mmHg whichever is greater exclusive of transducer 2 or 3 mmHg whichever is greater exclusive of Pati...

Страница 75: ...clusive of transducer 0 to 12 Hz or 0 to 40 Hz 3dB user selectable 0 30 0 40 0 60 0 100 0 160 0 200 0 300 mmHg 1 V 100 mmHg User selectable upper and lower limits for systolic diastolic and mean pressures 99 to 350 mmHg Measurement technique Oscillometric Displayed parameters Systolic diastolic and mean pressures pulse rate time of last measurement Measurement modes Manual Auto and Stat Heart rate...

Страница 76: ...atic cycle times Auto zero Tubing length Automatic cuff deflation Static 2 or 3 mmHg whichever is greater Clinical 5 mmHg average error 8 mmHg standard deviation 0 to 24 hours Zero pressure reference prior to each cuff inflation Variable Cycle time exceeding 3 minutes 85 seconds neonatal power off or cuff pressure exceeds 290 mmHg 6 mmHg for adult 250 mmHg 5mmHg for pediatric or 150 mmHg 3mmHg for...

Страница 77: ...nts This device is covered under one or more of the following U S A patents 5 758 644 5 823 950 6 011 986 6 157 850 6 263 222 6 501 975 and other applicable patents listed at http www masimo com patents htm Nellcor range SpO2 1 to 100 Pulse rate 20 to 250 beats per minute Nellcor accuracy1 70 to 100 SpO2 Adult 2 neonatal 3 69 SpO2 Unspecified Pulse rate 3 beats per minute without motion Analog out...

Страница 78: ... temperature accuracy 0 5 C 17 C to 30 C Injectate temperature range 0 C to 30 C 32 F to 86 F Injectate temperature accuracy 0 3 C Cardiac output review Accept reject individual measurements and store average Catheter sizes 5 6 7 7 5 or 8 French Injuectate volume selections 3 5 or 10 IEC EN UL 60601 1 CAN CSA C22 2 No 601 1 IEC EN 60601 1 2 IEC EN 60601 2 27 IEC EN 60601 2 30 IEC EN 60601 2 34 IEC...

Страница 79: ...Appendix A Technical Specifications 2030047 001A Patient Data Module A 11 Warranty One year warranty ...

Страница 80: ...A 12 Patient Data Module 2030047 001A Appendix A Technical Specifications ...

Страница 81: ...2030047 001A Patient Data Module B 1 B Appendix B Electromagnetic Compatibility ...

Страница 82: ...mal operation in the configuration in which it is being used Guidance and manufacturer s declaration electromagnetic emissions The Patient Data Module is intended for use in the electromagnetic environment specified below It is the responsibility of the customer or user to assure that the Patient Data Module is used in such an environment Emissions Test Compliance Electromagnetic Environment Guida...

Страница 83: ...nput output lines Mains power should be that of a typical commercial or hospital environment Surge EN 61000 4 5 1 kV differential mode 2 kV common mode 1 kV differential mode 2 kV common mode Mains power should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines EN 61000 4 11 5 Ut 95 dip in Ut for 0 5 cycles 40...

Страница 84: ...m output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site surveys should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol Note 1 ...

Страница 85: ...ries WARNING The use of accessories transducers and cables other than those specified may result in increased emissions or decreased immunity performance of the equipment or system The table below lists cables transducers and other applicable accessories with which GE claims EMC compliance NOTE Any supplied accessories that do not affect EMC compliance are not included Separation Distance in Meter...

Страница 86: ...9 in Lead wire set Multi Link individual grabber 130 cm 51 in Lead wire set Multi Link individual snap 130 cm 51 in Lead wire set Multi Link individual grabber V2 V6 130 cm 51 in Lead wire set 5 lead Multi Link snap 130 cm 51 in Lead wire set 5 lead Multi Link group snap 130 cm 51 in Lead wire set 3 lead Multi Link group snap 130 cm 51 in Lead wire set Multi Link neonatal mini clip DIN 60 cm 24 in...

Страница 87: ... Cable 20 cm 8 in Dual Temp Cable 1 2 m 4 ft Temp Probe Interconnect cable 400 series 3 6 m 12 ft Care cable dual temp 400 700 series 0 5 m 1 6 ft Care cable temp 400 700 series 0 5 m 1 6 ft Care cable temp single to disp 400 700 series 3 6 m 12 ft SpO2 cables and sensors Cable Masimo LNC 10 GE connector 3 0 m 9 8 ft Patient adapter cable Nellcor DIGICAL 3m one wire removed 3 0 m 0 8 ft Care SpO2 ...

Страница 88: ...check sensor N A Masimo sensor LNOPTF I reusable forehead sensor N A Masimo sensor LNOP NEO L neonate adhesive sensor N A Masimo sensor LNOP NEOPT L sensitive skin neo adhesive sensor N A Masimo sensor LNOP INF L infant adhesive sensor N A Masimo sensor LNOP NEO bridge neonate adhesive sensor N A Masimo sensor LNOP NEOPT sensitive skin bridge neonate adhesive sensor N A Masimo sensor LNOPv In disp...

Страница 89: ...and OXI P I pediatric infant reusable N A Nellcor Dura Y D YS multi site sensor N A Nellcor D YSE ear clip for Dura_Y sensor N A Nellcor PediCheck D YSPD pediatric spot check sensor N A Nellcor OxiCliq adhesive sensor adult N A Nellcor OxiCliq adhesive sensor neonatal adult N A Nellcor OxiCliq adhesive sensor infant N A Nellcor OxiCliq adhesive sensor pediatric N A Accessories Cable defib sync to ...

Страница 90: ...B 10 Patient Data Module 2030047 001A Appendix B Electromagnetic Compatibility ...

Страница 91: ......

Страница 92: ...s GmbH Munzinger Straße 3 5 D 79111 Freiburg Germany Tel 49 761 45 43 0 Fax 49 761 45 43 233 Asia Headquarters GE Medical Systems Information Technologies Asia GE China Co Ltd 24th Floor Shanghai MAXDO Center 8 Xing Yi Road Hong Qiao Development Zone Shanghai 200336 P R China Tel 86 21 5257 4650 Fax 86 21 5208 2008 GE Medical Systems Information Technologies a General Electric Company going to mar...

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