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Revision B

SEER Light Ambulatory Recorder/Controller

1-11

2019818-008

Introduction: Responsibility of the Manufacturer

Information Technology Equipment

The hardware components supplied by GE for the MARS

®

Holter

analysis workstation, on which the SEER Light Connect application
runs, are considered to be Information Technology Equipment (ITE).
These individual components have been found to comply with the
standard for Safety of Information Technology Equipment, including
Electrical Business Equipment EN60950 (UL 60950).

The software used in the MARS

®

Holter analysis workstation

is

considered as medical software. The software has been designed and
manufactured to the appropriate medical regulations and controls.

In order for the MARS

®

Holter analysis workstation to comply with

medical equipment standard leakage current requirements, a medical
grade uninterruptible power supply (UPS) must be used (UL 60601-1,
CSA 22.2 No. 60601-1, EN 60601-1) to power all non-medical equipment.

In addition, non-medical electrical equipment must comply with IEC and
ISO safety standards that are relevant to that equipment (i.e., IEC
60950, Safety of Information Technology Equipment.)

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Summary of Contents for SEER Light

Page 1: ... Recorder Controller Service Manual Software Version 1 2019818 008 Revision B Service Instructions for SEER Light SEER Light Extend Compact Digital Holter Recorder SEER Light SEER Light Extend Controller SEER Light Connect ...

Page 2: ...to earlier software versions Due to continuing product innovation specifications in this manual are subject to change without notice Marquette MARS MUSE and SEER are trademarks owned by GE Medical Systems Information Technologies a General Electric Company going to market as GE Healthcare All other marks are owned by their respective owners 2005 General Electric Company All rights reserved ...

Page 3: ... Light Extend Recorder 2 1 Component Names and Locations 2 3 Structure 2 3 Troubleshooting 2 5 Self Test Mode 2 5 No Buzzer Sound After Installing the Batteries 2 6 Beep Sound Will Not Stop After Installing the Batteries 2 7 ECG Cannot Be Previewed with Controller I R 2 8 ECG Cannot be Previewed with Controller Cable 2 9 ECG Cannot Be Previewed with SEER Light Connect Device 2 10 Recording Cannot ...

Page 4: ...eviewed by the Controller Cable 3 8 Cannot Start Recording I R 3 9 Pressing the Appropriate Key s Does Not Start Operation 3 10 Beep Sounds While the Flash Card is Inserted 3 11 Data Cannot be Transferred from the Recorder 3 12 Recording Start Date Time is Not Correct 3 13 Time is Not Correct 3 13 Inspection 3 14 4 SEER Light Connect 4 1 Component Names and Locations 4 3 Structure 4 3 Troubleshoot...

Page 5: ...ications A 3 SEER Light SEER Light Extend Ambulatory Recorder A 3 SEER Light Ambulatory Controller A 4 SEER Light Connect Device A 5 Electromagnetic Compatibility B 1 Electromagnetic Compatibility EMC B 3 Guidance and Manufacturer s Declaration Electromagnetic Emissions B 3 Guidance and Manufacturer s Declaration Electromagnetic Immunity B 4 Recommended Separation Distances B 6 Compliant Cables an...

Page 6: ...iv SEER Light Ambulatory Recorder Controller Revision B 2019818 008 ...

Page 7: ...Revision B SEER Light Ambulatory Recorder Controller 1 1 2019818 008 1 Introduction ...

Page 8: ...1 2 SEER Light Ambulatory Recorder Controller Revision B 2019818 008 For your notes ...

Page 9: ...r the instructions necessary to operate the equipment safely in accordance with its function and intended use Definitions Items shown in Black text are keys on the keyboard text to be entered or hardware items such as buttons or switches on the equipment Items shown in Italicized text are software terms which identify menu items buttons or options in various windows To perform an operation which a...

Page 10: ...1 4 SEER Light Ambulatory Recorder Controller Revision B 2019818 008 Introduction Manual Information Enter means to press the Enter or Return key on the keyboard Do not type enter ...

Page 11: ...ntroller 1 5 2019818 008 Introduction Related Manuals Related Manuals See the documents listed below for additional information Table 2 SEER Light Documents Part Number Name 2019818 007 SEER Light Ambulatory Recorder Controller Operator s Manual ...

Page 12: ...on DANGER indicates an imminent hazard which if not avoided will result in death or serious injury WARNING indicates a potential hazard or unsafe practice which if not avoided could result in death or serious injury CAUTION indicates a potential hazard or unsafe practice which if not avoided could result in minor personal injury or product property damage NOTE provides application tips or other us...

Page 13: ...of its electrically connected peripheral devices are isolated from mains power to prevent excessive leakage current to the patient This can be accomplished through the use of isolated mains power or a medical grade isolation transformer in compliance with UL 60601 CAN CSA C22 2 No 601 1 IEC 60601 1 with this system All non medical peripheral devices shall comply with IEC and ISO safety standards t...

Page 14: ...ion of the device it is necessary to periodically have the device checked by authorized service personnel Check the patient cable and connectors every month by connecting them to an ECG simulator INSTALLATION Adhere to the following recommendations during installation Install and keep device away from splashing water Do not install the device where it may be affected by humidity ventilation direct...

Page 15: ...n Safety Information Disposal of the Device When disposing the device follow the applicable national rules and regulations of disposal of medical equipment When disposing the recyclable battery follow the applicable national rules and regulations concerning the environmental issues ...

Page 16: ...or use under the direct supervision of a licensed health care practitioner To ensure patient safety use only parts and accessories manufactured or recommended by GE Contact GE for information before connecting any devices to this equipment that are not recommended in this manual Parts and accessories used must meet the requirements of the applicable IEC 60601 series safety standards and or the sys...

Page 17: ...cal Business Equipment EN60950 UL 60950 The software used in the MARS Holter analysis workstation is considered as medical software The software has been designed and manufactured to the appropriate medical regulations and controls In order for the MARS Holter analysis workstation to comply with medical equipment standard leakage current requirements a medical grade uninterruptible power supply UP...

Page 18: ...hould have when you insert it into the unit This unit requires you to insert the batteries so that the polarities are oriented in alternating directions Power Stop Input connector Output connector This symbol indicates that the waste of electrical and electronic equipment must not be disposed as unsorted municipal waste and must be collected separately Please contact an authorized representative o...

Page 19: ...Revision B SEER Light Ambulatory Recorder Controller 2 1 2019818 008 2 SEER Light SEER Light Extend Recorder ...

Page 20: ...2 2 SEER Light Ambulatory Recorder Controller Revision B 2019818 008 For your notes ...

Page 21: ...he LED will flash every second B start event button Use to start recording Use to mark events during recording C battery compartment cover Slide the cover to open and set the batteries in the battery compartment D A data output connector For transfer of data to the SEER Light controller or to the SEER Light Connect device E access LED Will flash during communication with the SEER Light controller ...

Page 22: ... Revision B 2019818 008 SEER Light SEER Light Extend Recorder Component Names and Locations I patient cable connector Used to connect patient cable for ECG input J Stop button Push to stop recording Table 3 SEER Light Ambulatory Recorder Continued ...

Page 23: ...with an ECG simulator To enter the pacemaker detection mode set the batteries while pressing the STOP button Confirm the audible sound synchronizes with the pacemaker signal input through the patient input connector Remove the batteries to end the self test 2 Self test II accelerometer sensor check mode After setting the batteries press the STOP button three times within a second Confirm the audib...

Page 24: ...nstalling the batteries Are the batteries installed properly Install the batteries properly Are the batteries new Replace with new batteries Were the batteries reinstalled over 10 seconds after the batteries were removed Reinstall the batteries over 10 seconds after removing them Are the battery electrodes clean and properly soldered Call GE service Call GE service Yes Yes Yes Yes No No No No ...

Page 25: ...xtend Recorder Troubleshooting Beep Sound Will Not Stop After Installing the Batteries Beep sound will not stop after installing the batteries Are the batteries new Replace with new alkaline batteries Are the alkaline batteries installed Set new alkaline batteries Call GE service Yes Yes No No ...

Page 26: ... 5 m Position the controller within 4 9 ft 1 5 m Is the I R window facing the controller properly Reposition the I R window properly to the controller or remove any obstacle between the recorder and the controller Were the batteries set within one hour Reset the batteries Has recording already started Call GE service Preview ECG with the cable Cannot preview ECG by I R operation if more than 3 min...

Page 27: ...EER Light Extend Recorder Troubleshooting ECG Cannot be Previewed with Controller Cable ECG cannot be previewed with the controller by the preview cable Is cable connection proper Connect the cable properly Is the cable damaged Replace with a new cable Call GE service Yes No No Yes ...

Page 28: ...hin 4 9 ft 1 5 m Is the I R window facing the controller properly Reposition the I R window properly or remove any obstacle between the recorder and the controller Were the batteries installed within one hour Reinstall the batteries Has recording already started Call GE service Cannot preview ECG by I R operation if more than 3 minutes has elapsed since recording started Yes No Yes Yes No No No Ye...

Page 29: ...ress the START button when the controller displays Data still remains Does the controller display Already started Reset the batteries over 30 seconds after removing them Is the distance from the controller within 4 9 ft 1 5 m Adjust the position within 4 9 ft 1 5 m from the controller Does the I R window face the controller properly Reposition the I R windows to face each other properly Remove any...

Page 30: ...controller display Already started Reinstall the batteries over 30 seconds after removing them Is the distance from the Connect within 4 9 ft 1 5 m Adjust the position within 4 9 ft 1 5 m from the Connect Does the I R window face the Connect properly Reposition the I R windows to face each other properly Remove any obstacles between the recorder and the Connect Call GE Service Yes Yes No No Yes Ye...

Page 31: ... Recorder Troubleshooting Cannot Start by Pressing the Start Button Cannot start by pressing the START button Was the START button pressed over 1 5 seconds Press the START button longer than 1 5 seconds Is it within one hour of setting the batteries Reset the batteries Call GE Service Yes Yes No No ...

Page 32: ...ifacts in the ECG recording Refer to flow chart on artifact later in this chapter Were the batteries removed before recording for 24 hours Don t remove the batteries before recording for 24 hours Were alkaline batteries used Use alkaline batteries Are the battery electrodes dirty or improperly soldered Clean the battery electrodes or improve soldering Call GE Service Yes No No No Yes Yes No Yes ...

Page 33: ...rtifact later in this chapter Were the batteries removed before recording for 48 hours Don t remove the batteries before recording for 48 hours Were alkaline batteries used Use alkaline batteries Are the battery electrodes dirty or improperly soldered Clean the battery electrodes or improve soldering Call GE Service Yes No No No Yes Yes No Yes Is the recorder labeled SEER Light Extend The recorder...

Page 34: ...ller Is the transfer cable properly connected Connect the cable properly Does the controller display No data in the recorder No data in the recorder Record ECG again Does the controller display Recorder contains data error Call GE Service Is the data output connector clean Clean the data output connector Call GE Service No Yes Yes No No Yes Yes No Is the transfer cable damaged Call GE Service No Y...

Page 35: ...Connect the cable properly Does the controller display No data in the recorder No data in the recorder Record ECG again Is the data output connector clean Clean the data output connector Call GE Service No Yes Yes No Yes No Is the transfer cable damaged Call GE Service No Yes Is the USB cable from the Connect plugged in Plug it in Yes No Is the orange LED on the Connect on Attach the Connect to th...

Page 36: ...ized Was the recording started by pressing the START button Call GE Service Were the batteries removed during or after recording Record start date time will be initialized if the batteries are removed before transferring the ECG data after the START button is pressed to start recording Replace the batteries Yes No No Yes Did more than one week pass from the last recording Call GE Service No Yes ...

Page 37: ...cording Artifact on ECG recording Are electrodes connected properly on the patient Attach electrodes properly Is the patient cable connected properly Connect the patient cable properly Is the patient cable connector clean Clean the patient cable connector Is the patient cable damaged Call GE Service Call GE Service Yes No Yes Yes No No No Yes ...

Page 38: ...e Insert the batteries while pressing the STOP button Disconnect the patient cable and touch the electrode connector with a finger Does audible beep sound Normal pacemaker detection circuit Confirm pacemaker pulse detection by the Preview function of the controller Reposition the CH1 if the pulse signals are too small Call GE Medical Systems Information Technologies Service No Yes ...

Page 39: ...Revision B SEER Light Ambulatory Recorder Controller 3 1 2019818 008 3 SEER Light SEER Light Extend Controller ...

Page 40: ...3 2 SEER Light Ambulatory Recorder Controller Revision B 2019818 008 For your notes ...

Page 41: ...A A 1 2 in 30 mm 3 5 in 90 mm 7 9 in 200 mm C D E F G H I J K B L Table 4 Controller Parts List Item Name Description A input connector Used to connect to the SEER Light recorder to check recording conditions NOTE This feature is reserved for future use B infrared terminal Used to communicate with the SEER Light recorder Transfer the instructions to a SEER Light recorder before recording Receive E...

Page 42: ...ating conditions G F1 button Used to enter the preview mode wired or wireless to confirm the quality of ECG recording H F2 button Used to enter the data transfer mode to transmit data to a Holter card I F3 button Used to start recording of the SEER Light recorder and to start transferring data to a Holter card J set up button Used to select settings K patient information entry buttons Enter the pa...

Page 43: ...lay mode Press the number 0 at the Factory Settings display mode The name of the button that was pressed will be displayed and an audible sound will be heard when the respective button is pressed once NOTE If the ENTER button is pressed three times the unit will enter into the LCD check mode Turn off the power to end this function test 2 LCD check mode Enter the Set up Condition display mode by pr...

Page 44: ...rting Batteries and Pressing Power Button No operation after inserting batteries and pressing the POWER button Are the batteries set properly Set the batteries properly Do the batteries have sufficient power of 4 5 V Replace with new batteries Did the beep sound when the POWER button was pressed Call GE service No Yes Yes No No Yes Call GE service ...

Page 45: ...ion over 3 minutes after recording started ECG cannot be previewed with the controller I R Communication Error Is the distance from the recorder within 4 9 ft 1 5 m Position the recorder within 4 9 ft 1 5 m Is the I R window facing the recorder properly Reposition the I R window properly to the recorder or remove any obstacle between the recorder and the controller Has recording already started No...

Page 46: ...ht SEER Light Extend Controller Troubleshooting ECG Cannot be Previewed by the Controller Cable ECG cannot be previewed by the controller by the preview cable Is cable connection proper Connect the cable properly Is the cable damaged Call GE service Call GE service Yes No No Yes ...

Page 47: ...he SEER Light cannot start by I R operation Does the controller display Already started Reset the batteries over 30 seconds after removing them Is the distance from the recorder within 4 9 ft 1 5 m Adjust the position within 4 9 ft 1 5 m from the recorder Does the I R window face the controller properly Reposition the I R windows to face each other properly Remove any obstacles between the recorde...

Page 48: ...ontroller Troubleshooting Pressing the Appropriate Key s Does Not Start Operation Pressing the appropriate key s does not start operation Can the operation panel key s be pressed properly Call GE service Is there debris between PC board and key sheet panel Call GE service Call GE service Yes No No Yes ...

Page 49: ...roller Troubleshooting Beep Sounds While the Flash Card is Inserted Beep sounds while the flash card is inserted The display is distorted Is the flash card inserted completely Insert the card completely Is the card inserted in the opposite direction Insert the card properly Call GE service Yes No No Yes ...

Page 50: ... the recorder Is the data output connector clean Clean the connector Is the connector damaged Replace the connector Call GE service Yes No No Yes Has the compact flash card been formatted Format the compact flash card Is the card defective Replace with a new card Yes No No Yes Does data remain on the card Transfer the data to the PC Are there distorted card connector pins Call GE service No No Yes...

Page 51: ... Date Time is Not Correct Time is Not Correct Recording start date time is not correct Is date within one month Adjust date See next flowchart Yes No Time is not correct Is it within 5 years of use Call GE service Are the battery electrodes clean or properly solder Clean the electrodes or improve soldering Replace the PC boards Yes Yes No No ...

Page 52: ...tch and check buzzer sound and LED blinking are stopped 7 Start test Ensure that the SEER Light is starting straight line 1 5 m 8 IrDA preview check Use SEER Light which is pre installed with ECG wave and ensure that the displayed waveform of 1 ch 2 ch and 3 ch are normal under the preview function 9 Preview check with cable Use SEER Light which is pre installed with ECG wave and ensure that the d...

Page 53: ...Revision A SEER Light Ambulatory Recorder Controller 4 1 2019818 008 4 SEER Light Connect ...

Page 54: ...4 2 SEER Light Ambulatory Recorder Controller Revision A 2019818 008 For your notes ...

Page 55: ...part on the SEER Light Connect 084A A B D C Name Function A data transfer cable Used to transfer data from the SEER Light recorder to the SEER Light Connect B infrared terminal Used to communicate with the SEER Light recorder Receives ECG waveform data from a SEER Light recorder to preview Transfers patient demographics to the SEER Light recorder Starts the SEER Light recorder C USB Connection Use...

Page 56: ...ains power to prevent excessive leakage current to the patient This can be accomplished through the use of isolated mains power or a medical grade isolation transformer in compliance with UL 60601 CAN CSA C22 2 No 601 1 IEC 60601 1 with this system All non medical peripheral devices shall comply with IEC and ISO safety standards that are relevant to that equipment i e IEC 60950 UL 60950 Use of the...

Page 57: ... 1 5 m Is the I R window facing the controller properly Reposition the I R window properly or remove any obstacle between the recorder and the controller Were the batteries installed within one hour Reinstall the batteries Has recording already started Call GE service Cannot preview ECG by I R operation if more than 3 minutes has elapsed since recording started Yes No Yes Yes No No No Yes Is the U...

Page 58: ... display Already started Reinstall the batteries over 30 seconds after removing them Is the distance from the Connect within 4 9 ft 1 5 m Adjust the position within 4 9 ft 1 5 m from the Connect Does the I R window face the Connect properly Reposition the I R windows to face each other properly Remove any obstacles between the recorder and the Connect Call GE Service Yes Yes No No Yes Yes No No Is...

Page 59: ...e cable properly Does the controller display No data in the recorder No data in the recorder Record ECG again Is the data output connector clean Clean the data output connector Call GE Service No Yes Yes No Yes No Is the transfer cable damaged Call GE Service No Yes Is the USB cable from the Connect plugged in Plug it in Yes No Is the orange LED on the Connect on Attach the Connect to the recorder...

Page 60: ...rder Controller Revision A 2019818 008 SEER Light Connect Troubleshooting Recording Start Date Time is Not Correct Recording start date time is not correct Is date correct on the PC Adjust date time on the PC Call GE Service Yes No ...

Page 61: ...Revision B SEER Light Ambulatory Recorder Controller 5 1 2019818 008 5 Maintenance ...

Page 62: ...5 2 SEER Light Ambulatory Recorder Controller Revision B 2019818 008 For your notes ...

Page 63: ...rols for proper operation Inspect the LCD to make sure all the segments function Precautions Do not immerse any part of the equipment in water Do not use organic solvents ammonia based solutions or abrasive cleaning agents which may damage equipment surfaces NOTE Remove the batteries before cleaning Cleaning Clean the exterior surfaces with a clean soft cloth and a mild dishwashing detergent dilut...

Page 64: ...B 2019818 008 Maintenance Storing the Recorder Storing the Recorder When the SEER Light Recorder Controller will not be in use for a period of time Remove the batteries Disconnect and properly store any patient cables Memory card may remain in the recorder ...

Page 65: ...Revision B SEER Light Ambulatory Recorder Controller 5 5 2019818 008 Maintenance Maintenance Repair Log Maintenance Repair Log Unit Serial Number Institution Name Date Maintenance Repair Technician ...

Page 66: ...5 6 SEER Light Ambulatory Recorder Controller Revision B 2019818 008 Maintenance Maintenance Repair Log Maintenance Repair Log Unit Serial Number Institution Name Date Maintenance Repair Technician ...

Page 67: ...Revision B SEER Light Ambulatory Recorder Controller A 1 2019818 008 Appendix A Technical Specifications ...

Page 68: ...A 2 SEER Light Ambulatory Recorder Controller Revision B 2019818 008 For your notes ...

Page 69: ...y 10 to 95 relative humidity no condensation allowed Storage temperature 20 to 65 C 4 to 149 F Storage humidity 5 to 90 relative humidity no condensation allowed Material Aluminum ABSPC main body Recording time within 24 hours SEER Light within 48 hours SEER Light Extend Recording method Digital memory Power supply 2 x AAA Alkaline battery Recording channel ECG 3 channels Movement level 1 channel ...

Page 70: ...90 mm 3 5 in Depth 25 mm 1 2 in Weight 285 g 9 9 oz including batteries Operating temperature 10 to 35 C 50 to 95 F Operating humidity 10 to 95 relative humidity no condensation allowed Storage temperature 20 to 65 C 4 to 149 F Storage humidity 5 to 90 relative humidity no condensation allowed Power supply 4 x AAA Alkaline battery Vibration endurance Operation 0 5 G 10 to 20 Hz Non operation 3 0 G...

Page 71: ...cification Dimensions Height 13 mm 51 in Width 90 mm 3 54 in Depth 51 mm 2 01 in Cable length 260 mm 10 24 in Weight 87 g 19 lbs Operating temperature 10 to 35 C 50 to 95 F Operating humidity 10 to 95 relative humidity no condensation allowed Storage temperature 20 to 65 C 4 to 149 F Storage humidity 5 to 90 relative humidity no condensation allowed Power supply DC 5V Recorders SEER Light Recorder...

Page 72: ...A 6 SEER Light Ambulatory Recorder Controller Revision B 2019818 008 Appendix A Technical Specifications For your notes ...

Page 73: ...Revision B SEER Light Ambulatory Recorder Controller B 1 2019818 008 Appendix B Electromagnetic Compatibility ...

Page 74: ...B 2 SEER Light Ambulatory Recorder Controller Revision B 2019818 008 For your notes ...

Page 75: ...to verify normal operation in the configuration in which it is being used Guidance and Manufacturer s Declaration Electromagnetic Emissions The SEER Light recorder and controller are intended for use in the electromagnetic environment specified below It is the responsibility of the customer or user to ensure that the SEER Light recorder and controller are used in such an environment Emissions Test...

Page 76: ...ansient burst EN 61000 4 4 2 kV for power supply lines 1 kV for input output lines 2 kV for power supply lines 1 kV for input output lines Not applicable The SEER Light recorder and controller are not powered by Mains power Surge EN 61000 4 5 1 kV differential mode 2 kV common mode 1 kV differential mode 2 kV common mode Not applicable The SEER Light recorder and controller are not powered by Main...

Page 77: ...itter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site surveya should be less than the compliance level in each frequency rangeb Interference may occur in the vicinity of equipment marked with the following symbol NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guid...

Page 78: ... the maximum output power of the communications equipment For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts w according to the transmitter manufacturer NOTE These guidelines may not a...

Page 79: ...ssions or decreased immunity performance of the equipment or system The table below lists cables transducers and other applicable accessories with which GE Medical Systems claims EMC compliance NOTE Any supplied accessories that do not affect EMC compliance are not included Part No Description Maximum Lengths 2008750 002 SEER Light 64MB Compact Flash NA 2008751 001 Compact Flash to PC Adapter NA 2...

Page 80: ...B 8 SEER Light Ambulatory Recorder Controller Revision B 2019818 008 Electromagnetic Compatibility Electromagnetic Compatibility EMC For your notes ...

Page 81: ...Revision B SEER Light Ambulatory Recorder Controller Index 1 2019818 008 Index ...

Page 82: ...Index 2 SEER Light Ambulatory Recorder Controller Revision B 2019818 008 ...

Page 83: ...on 7 E Electrosurgery warning 7 Equipment Symbols 12 Equipment symbols 9 Event 12 F Function buttons F1 F2 F3 4 H Holter card slot 4 I IEC 10 immersion in water 3 information technology equipment 11 Infrared terminal 3 Input connector 12 3 Intended use 6 L LCD 4 Leakage current warning 7 4 M Maintenance 5 3 manual definitions 3 purpose 3 revision history 3 manuals related 5 Modifications caution 8...

Page 84: ...Index Index 4 SEER Light Ambulatory Recorder Controller Revision B 2019818 008 ...

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