GE SEER 1000 - Page 107

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Table of Contents3
Introduction9
Intended User10
Indications for Use10
Intended Use10
Contraindications10
Prescription Device Statement10
Regulatory and Safety Information10
Safety Conventions11
Safety Hazards11
Medical Device Classification16
Certification17
Input Signal Reproduction Accuracy17
EMI/EMC/RF Caution17
Biocompatibility18
Supply and Accessory Information19
Manufacturer Responsibility19
Product and Package Information19
Equipment Identification26
Product Label26
Serial Number Format and Product Code27
Service Information27
Service Requirements27
Warranty Information28
Additional Assistance28
Manual Information28
Manual Purpose28
Document Conventions28
Related Documents30
Product Overview31
Recorder and Application - General31
Operating Elements of the Recorder32
Event Button33
Event Button LED34
Hookup Guidance LED34
Audible Notifications35
Preparing the Recording37
Instructing the Patient38
Safety Precautions38
Recording Diary38
Marking a Patient Event39
Preparing the Patient's Skin39
Placing the Electrodes40
Electrode Placement with 7 Leads for 3-Channel Recordings41
Electrode Placement with 5 Leads for 2-Channel Recordings42
Electrode Placement with 3 Leads for the Recording of43
Non-Independent ECG Channels43
Connecting the ECG Cable to the Recorder and to the Electrodes44
Inserting a Battery45
Reattaching or Replacing the Battery Compartment Door46
Switching on the Recorder46
Starting the Recording47
Auto-Start47
Auto-Switch-Off48
After Completing the Recording49
Switching off before the Recording Duration Has Been Reached49
Removing the Electrodes50
Transferring the ECG Data to a PC50
Compatible Evaluation Software50
Applications (Apps) - General Information51
Functionality52
Data Protection53
App Data Protection53
Recorder Data Protection53
Basic Information on Wireless Bluetooth Connection54
Using the Apple Ios App57
Installing and Setting up the App57
Installing and Starting the App57
Changing the Administrator Password58
Add Technician or Reset Technician Password59
Reset Application60
Starting the App and Changing the Technician Password61
Patient Hookup62
Add or Select a Patient63
Find Device63
Electrode Placement and Waveform Preview64
Verify or Change Settings65
Start the Recording66
Patients Tab67
Devices Tab68
Using the Microsoft Windows App69
Installing and Setting up the App69
Hardware Specifications69
Using the Bluetooth Adapter70
Installing and Starting the PC App70
Removing the PC App71
Changing the Administrator Password71
Add Technician or Reset Technician Password72
Reset Application73
Starting the App and Changing the Technician Password74
Patient Hookup76
Add or Select a Patient76
Electrode Placement and Waveform Preview78
Verify or Change Settings79
Start the Recording80
Patients Tab80
Devices Tab81
Troubleshooting83
Recorder Troubleshooting83
Application Troubleshooting85
Bluetooth Troubleshooting89
Bluetooth Messages from the Microsoft Windows System90
Resetting the Recorder with the Microsoft Windows App90
How to Notify Service if the Recorder Is Defective91
Maintenance93
Notices93
Cleaning and Disinfecting the Recorder94
Cleaning the Carrying Pouch95
Cleaning, Disinfecting, and Storing ECG Cables95
Cleaning ECG Cables95
Disinfecting ECG Cables96
Storing ECG Cables96
Cleaning the Battery Contacts96
Checking ECG Cable and Connectors96
Specifications97
General97
Electrical98
Mechanical98
Environmental99
Bluetooth Module99
EMC Specifications According to IEC 60601-1-2100
General Specifications, Table 201100
General Specifications, Table 202101
Non Life-Sustaining Systems, Table 204102
Recommended Separation Distances from Portable and Mobile RF Communications Equipment, Table 206103
Index105

GE SEER 1000 - Page 107

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