GE HEALTHCARE SEER 1000 Parts list manual

GE Healthcare
SEER ™ 1000 ECG recorder and software-Portuguese app
© 2016 General Electric Company All rights
reserved
SEER ™ 1000
ECG recorder and software-app usage
instructions
version 1.0
2067634-131 Revision E

2 SEER ™ 1000 2067634-131 Revision E
November 3, 2015
About this documentation
The information in this manual are for SEER ™ 1000 ECG recorder and software-app version 1.0. They do not apply to prior versions. Due to progressive product
innovation, the specifications listed in this manual are subject to change without notice.
This manual is the development and ownership of GETEMED Medizin- und Informationstechnik AG, Oderstr. 77, 14513 Teltow, Deutschland. The product has
a registered protective trademark of GE Healthcare.
SEER and MARS are the property of brand names GE Medical Systems Information Technologies, Inc., a business of General Electric Company, which stands as
GE Healthcare.
CardioDay is a brand owned by GETEMED AG.
iPad, iPhone, and iPod touch are trademarks of Apple Inc., registered in the US and other countries. "Made for iPod," "Made for iPhone," and "Made for iPad"
mean que an electronic accessory Has Been designed to connect Specifically to the iPod, iPhone, or iPad, respectivamente, and Has Been certified by the
developer to meet Apple performance standards. Apple is not Responsible for the operation of this device or its compliance with safety and regulatory standards.
Please note that the use of this device with an iPod, iPhone, or iPad may Affect wireless performance.
Microsoft and Windows are either registered trademarks or trademarks of Microsoft Corporation in the United States and / or other countries.
This product meets the regulatory requirements for medical devices of the following:
Revision History
The document number of the piece and the appointment of the review appear at the bottom of each page. The review refers to the level of document review.
The historical revision of this document is summarized in the following table.
Review Release date of description
THE November 8, 2013 first publication
B April 8, 2014 modified:
"Basic information about the wireless Bluetooth connection"
W May 26, 2015 EAC
D November 3, 2015 " Connect the ECG cable to the recorder and the electrodes "Page 46" Data protection on the " Connect the ECG cable to the recorder and the electrodes "Page 46" Data protection on the " Connect the ECG cable to the recorder and the electrodes "Page 46" Data protection on the " Connect the ECG cable to the recorder and the electrodes "Page 46" Data protection on the
recorder "57 page" Using the Apple iOS App ", Page 61 recorder "57 page" Using the Apple iOS App ", Page 61 recorder "57 page" Using the Apple iOS App ", Page 61 recorder "57 page" Using the Apple iOS App ", Page 61
Please contact the site is representative of GE Healthcare regarding other applicable documents.

2067634-131 Revision E SEER ™ 1000 3
Content
1Introduction ................................................. .................................................. .......... 9
Target group ............................................... .................................................. ...................................... 10
Indication ................................................. .................................................. ....................................... 10
Goal ................................................. .................................................. ...................................... 10
Contraindications ............................................... .................................................. ....................... 10
Device subject to prescription .............................................. .............................................. 10
Regulations and safety information ............................................. ................... 11
The meaning of the signal words ............................................ ........... 11
Safety instructions ............................................... ........................................... 12
Medical device classification .............................................. ..................... 17
Certification ................................................. .................................................. ................... 18
Accuracy of the input signal ............................................. ..................................... 18
Warning EMS / CEM / AF ............................................ .................................................. ..... 18
Biocompatibility ................................................. .................................................. .... 19
Information on spare parts and accessories ........................... 19
manufacturer's responsibility ............................................... ............................ 20
Information on the product and packaging ............................................ ........... 20
Identification of equipment ............................................... ............................................... 28
Nameplate ............................................... .............................................. 28
serial number and format of the product code ..................................... 29
Maintenance information .............................................. ....................................... 29
Maintenance requirements: .............................................. ....................................... 29
warranty information ............................................... .............................................. 30
Additional help ................................................ .................................................. ............. 30
Information on this instruction manual ............................................ ................ 30
Manual Purpose instructions ............................................. ...................... 30
Convention for the manual ............................................ .......... 31
Other applicable documents ............................................... ............................... 32

4 SEER ™ 1000 2067634-131 Revision E
2 Product Overview .............................................. ......................................... 33
Recorder App - General ............................................. ............................................ 33
Control elements of the recorder ............................................. ................................... 34
Event button ............................................... .................................................. ............ 35
LED of the event buttons ............................................. ........................................... 36
LED of electrodes ............................................... .................................................. 36 .........
Acoustic messages ................................................ .................................................. 37
3Preparing for recording ............................................... ........................................... 39
Inform the patient ............................................... .................................................. ................... 40
Safety notes for the patient ............................................ ..................... 40
Recording daily ............................................... .................................................. ...... 41
Mark patient event .............................................. ........................................... 41
Prepare the patient's skin ............................................. .................................................. .... 41
electrodes installation ............................................... .................................................. ........... 42
Arrangement electrodes 7 to three ECG channels ......................................... 43
5 Electrode arrangement for two ECG channels ......................................... 44
Layout of 3 electrodes for recording 3-channel ECG nãoindependentes
..................................... .................................................. ........ 45
Connect the ECG cable to the recorder and the electrodes ...................................... 46
Place the stack ............................................... .................................................. .............................. 47
Replace or replace the battery cover ........................................... ............................ 48
Connecting Recorder ............................................... .................................................. .......................... 49
Start recording ............................................... .................................................. ....................... 49
Auto-Start ............................................... .................................................. ......................... 50
Automatic shutdown ................................................ ........................................ 51
4Measures after the end of the recording ............................................ ...................... 53
Turn off the recorder before the end of the recording .......................................... ............... 53
Drop electrodes ................................................ .................................................. ........................... 53
Import recording to the PC ............................................ ................................................ 54
compatible evaluation software .............................................. ........................ 54

2067634-131 Revision E SEER ™ 1000 5
5Apps - General information .............................................. ................................. 55
Functionality ................................................. .................................................. ........................... 56
Privacy policy ............................................... .................................................. ............. 57
data protection in the App ............................................. .......................................... 57
Data protection on the recorder ............................................. .............................. 57
Basic information about the wireless connection Bluetooth ..................................... 58
6 Using the Apple iOS App ............................................. ................................ 61
Install and configure the application ............................................. ............................................ 61
Install and launch the application ............................................. ...................................... 61
Change the admin password ............................................. ........................... 62
Add technical or reset the password coach ........................................ 63
Configure the connection to MUSE wish list .......................................... ..66
Reset the application ............................................... .................................................. ..... 68
Start the application and change the technician password ......................................... ..................... 68
Save technician ID .............................................. .................................................. ................ 69
The tab "Patient" - Prepare and start ECG recording ...................................... .... 70
Add patients ................................................ .................................................. ... 70
Change or delete patient input ............................................ ................ 73
Search appliance ................................................ .................................................. ....... 74
Arrangement of electrodes and signal quality ........................................... ..76
Check or change the settings ............................................. .................... 77
Start recording ............................................... .................................................. ........ 78
The "Device" tab ............................................. .................................................. .................... 78
7 Using Microsoft Windows App ............................................. ............... 81
Install and configure the application ............................................. ............................................ 81
Hardware specifications ............................................... .................................... 81
Using a Bluetooth adapter .............................................. ................................. 82
Install and launch the PC application ........................................... ........................... 83
Remove PC App ............................................... .................................................. ........... 83
Change the admin password ............................................. ........................... 83
Add technical or reset the password coach ........................................ 85
Reset the application ............................................... .................................................. ..... 86
Start the application and change the technician password ......................................... ..................... 87

6 SEER ™ 1000 2067634-131 Revision E
Prepare and start the ECG guide - ECG .......................................... .......................................... 88
Add or select a patient, connect to a recorder .......................................
.................................................. ....................... 88
Arrangement of electrodes and signal quality ........................................... ..91
Check or change the settings ............................................. .................... 92
Start recording ............................................... .................................................. ........ 93
The tab "Patient" ............................................. .................................................. ........................... 93
The "Device" tab ............................................. .................................................. .................... 94
8 Problems solution ............................................... ........................................ 97
Solving problems Recorder ............................................. ...................................... 97
Application error messages ............................................. ........................................... 99
Bluetooth connection malfunctions .............................................. ............................................. 104
Connection faults MUSE .............................................. .................................................. .... 105
Bluetooth messages Microsoft Windows System ......................................... 106
Reset iOS App .............................................. .................................................. .................... 106
Reset with Microsoft Windows App ............................................. .................................... 107
How to inform the service that the recorder is defective .............................. 109
9Maintenance ................................................. .................................................. .... 111
Attention indications ............................................... .................................................. .......... 111
Clean and disinfect recorder .............................................. ............................................... 112
Clean the recorder bag ............................................. .................................................. . 113
Cleaning, disinfection and storage of ECG cables ................................ 113
Clear ECG cable ............................................... .................................................. ....... 113
Disinfect ECG cable ............................................... .................................................. 114
Storing ECG cable ............................................... 114 ................................................
Clean the battery contacts ............................................. .................................................. . 114
Check the ECG cables and connections .......................................... ......................... 114
THE Technical data ................................................ .................................................. 115
General ................................................. .................................................. .......................... 115

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Electronics ................................................. .................................................. 116 ....................................
Mechanical ................................................. .................................................. ..................................... 116
Environmental conditions ................................................ .................................................. .......... 117
Bluetooth module ................................................ .................................................. .................... 117
Specifications EMC IEC 60601-1-2 ........................................ ............ 118
General specifications table 201 ............................................. 118 ........................
General specifications table 202 ............................................. ........................ 119
Systems of non-life support table 204 .................................. 121
protection recommended distances between portable and mobile HF communication
devices and the device table 206 .............................. ..................................................
...................................... 122

1
2067634-131 Revision E SEER ™ 1000 9
1Introduction
This document describes the SEER 1000 ECG recorders and softwareapps SEER 1000, also
known as "systems", "device", "products" or "equipment". This manual is intended for users of
these devices.
There are three SEER 1000 ECG recorders, which differ in maximum recording time and
the color of the face;
• 24 hours (blue)
•48 hours (purple)
•7 days * (green)
* Long-term MARS ECG analysis system supports the ECG recording during a period of up to three days.
All three SEER 1000 ECG recorders are for use both in adults, but also suitable for pediatric
patients (including patients weighing less than 10 kg). Inquire please about any restrictions on the
long-term ECG analysis seusoftware operating instructions.
They can be purchased two software applications, one for the Apple iOS App and the other as a
software application for the Microsoft Windows operating system. Both applications are designed
to transmit patient data to a recorder for recording the preparation, visually examine the ECG
curves, changing the recorder settings, and start recording. The use of these apps is optional.

Introduction
10 SEER ™ 1000 2067634-131 Revision E
This chapter contains general information that is necessary for proper use of the goods and this
instruction manual. Familiarize yourself with this information before using the system.
Target group
The devices are intended for use by trained users in hospitals and medical centers, under
the direct supervision of a qualified physician.
Indication
The SEER 1000 is a recorder to ECG long-term, indicated for patients who could benefit from a
continuous long-term ECG recording. These are for example patients who complain of
palpitations, chest pain or shortness of breath, or patients who should be monitored for their
ability current heart can be evaluated.
Goal
The ECG SEER 1000 long-term recorder is designed for continuous recording of ECG data. The
recorder does not make any cardiac analysis and is intended to be used in conjunction with a
long-term ECG analysis software. The recorded data are downloaded on a PC, to be then be
analyzed and evaluated by a doctor or experienced specialist.
Contraindications
Contraindications to the use of the equipment are not known.
subject to prescription device
CAUTION
Note that in the US a national law only allows the appliance to be used by a physician or
under his order.