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Preparing the Recording

2067634-077 Revision B

SEER™ 1000

Electrode Placement with 3 Leads for the Recording of
3 Non-Independent ECG Channels

To record 3 non-independent ECG channels, three electrodes are at-
tached and connected to the color-coded leads.

AHA Color Coding

IEC Color Coding

AHA Color

IEC Color

Location

White

Red

Right manubrial border of sternum

Black

Yellow

Right border of sternum, 7th rib

Red

Green

Left lower rib cage

Summary of Contents for SEER 1000

Page 1: ...hcare SEER 1000 ECG Recorder and Mobile Application English 2014 General Electric Company All Rights Reserved SEER 1000 ECG Recorder and Mobile Application Operating Manual Version 1 0 2067634 077 Rev...

Page 2: ...en designed to connect specifically to the iPod iPhone or iPad respectively and has been certified by the developer to meet Apple performance stand ards Apple is not responsible for the operation of t...

Page 3: ...tion 16 Certification 17 Input Signal Reproduction Accuracy 17 EMI EMC RF Caution 17 Biocompatibility 18 Supply and Accessory Information 19 Manufacturer Responsibility 19 Product and Package Informat...

Page 4: ...th 7 Leads for 3 Channel Recordings 41 Electrode Placement with 5 Leads for 2 Channel Recordings 42 Electrode Placement with 3 Leads for the Recording of 3 Non Independent ECG Channels 43 Connecting t...

Page 5: ...the App and Changing the Technician Password 61 Patient Hookup 62 Add or Select a Patient 63 Find Device 63 Electrode Placement and Waveform Preview 64 Verify or Change Settings 65 Start the Recording...

Page 6: ...dows System 90 Resetting the Recorder with the Microsoft Windows App 90 How to Notify Service if the Recorder is Defective 91 9 Maintenance 93 Notices 93 Cleaning and Disinfecting the Recorder 94 Clea...

Page 7: ...cording to IEC 60601 1 2 100 General Specifications Table 201 100 General Specifications Table 202 101 Non Life Sustaining Systems Table 204 102 Recommended Separation Distances from Portable and Mobi...

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Page 9: ...e for use with both adult and pediatric patients including those patients weighing less than 10 kg Please refer to the manual of your Holter analysis software for restrictions There are two applicatio...

Page 10: ...y record ECG data The SEER 1000 performs no cardiac analysis by itself and is in tended to be used with an ECG analysis software package The recorded data are downloaded to a PC for analysis and subse...

Page 11: ...ndicates 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 in...

Page 12: ...from the recorder WARNING EXPLOSION HAZARD Electrical sparks can cause explosions in the presence of certain gases Do not use device in an oxygen enriched environment or around other flammable or expl...

Page 13: ...uitable packaging and labeling o Contact the addressee before sending the equipment o Clean the recorder and accessories after every use For infor mation refer to the chapter Maintenance on page 93 WA...

Page 14: ...epara tion can cause unsatisfactory ECG quality Prepare the patient for the recording as described in the chapter Preparing the Recording on page 37 NOTICE INSUFFICIENT RECORDING QUALITY Defective dev...

Page 15: ...proper training to repair the device Repairs carried out by unauthorized personnel could result in damage to the device or accessories Send the device for inspection to an authorized facility if you f...

Page 16: ...esponsibility of the medical doctor to provide the patient with the information required for the ECG recording See Instructing the Patient on page 38 for more information NOTICE INTERFERENCE Electrica...

Page 17: ...01 2 47 Input Signal Reproduction Accuracy The frequency response meets the following IEC 60601 2 47 Part 51 5 9 requirements The response of the recorder to a 5 mV 100 ms rectangular pulse does not s...

Page 18: ...d portable phones or other electronic equipment that may emit radio frequency RF near this system WARNING ACCESSORIES COMPONENTS Adding accessories or components or modifying the medical device or sys...

Page 19: ...s used in accordance with the instructions for use GE Healthcare is contacted for information before any devices that are not recommended in this manual are connected to the equip ment Product and Pac...

Page 20: ...one intended for contact with patients for cardiac application IP43 IP Code Ingress Protection Rating Classifies and rates the degree of protection provided against the intrusion of solid objects such...

Page 21: ...or product As a mandatory action sign this symbol is identified by a blue background and white symbol Temperature Limits Indicates the upper and lower temperature limitations for the transportation a...

Page 22: ...Indicates the device or product meets the regulations limit or ban for specific substances in new electronic and elec tric equipment in Japan The Green Mark with the G indi cates the product is within...

Page 23: ...uct complies with FCC Rule Part 18 Subpart B 18 203 General information regarding applications and authorizations for industrial scientific and medical ISM equipment T VRheinland Indicates the device...

Page 24: ...the apps for female patients Male This symbol is selected in the apps for male patients Select for deletion This symbol is selected in the Apple iOS app to select a pa tient or technician for deletio...

Page 25: ...ent Label Locations This section identifies the labels and their locations on the product and packaging See the Symbols section on page 19 for detailed descrip tions Item Label Location Description 1...

Page 26: ...epending on the product the label may vary slightly in format but it contains the same in formation For explanations of the symbols see the Symbols section on page 19 Item Description SEER 1000 Model...

Page 27: ...evice wasmanufactured Val ues for production range from 00101 to 99999 Service Information This section provides information pertaining to the maintenance and ser vicing of the system Familiarize your...

Page 28: ...ct use of this manual Keep this manual with the equipment at all times and periodically review it You should request training assistance from GE Healthcare if needed Manual Purpose This manual provide...

Page 29: ...ise text string with one or more spaces the point where you must press the spacebar is indicated as space This en sures that the correct number of spaces is inserted in the correct positions within th...

Page 30: ...called out from the body text through a flag word and indentation Related Documents The following documents are referenced in this manual and provide addi tional information that may be helpful in th...

Page 31: ...ecorded depends solely on the type of ECG cable used The devices automatically detect pacemaker pulses as a standard fea ture No user settings are required for pacemaker detection The recorders may be...

Page 32: ...are transferred to the evaluation workstation using a spe cial USB cable Operating Elements of the Recorder 1 Event Button 2 Event Button LED 3 Combined ECG Cable Connector and USB Cable Connector 4 H...

Page 33: ...holding the Event Button will activate the wireless connectivity Start a recording with out the app Press and release A double beep will sound to confirm the recording has started Mark an event during...

Page 34: ...Refer to the section How to Notify Service if the Recorder is Defective on page 90 for more information Fast flashing green and yellow al ternating Hookup Guidance LED Prior to recording this two colo...

Page 35: ...ble Notifications The SEER 1000 provides the following audible feedback Status Buzzer Notification Recorder is turned on Short single beep Recording has started Double beep Recording cannot start e g...

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Page 37: ...tep 6 you can proceed using the respective app for entering patient demographic data and for checking the signal quality We recommend the following steps to prepare the recording Each step is describe...

Page 38: ...w 5 C 41 F or above 45 C 113 F In hot climates stay in temperature controlled environments as much as possible In cold climates wear the re corder under outer garments Do not expose the device to sudd...

Page 39: ...iefly during a recording to mark an event A short beep informs the patient that the event has been marked A second marker can be used to indicate the end of an event The physician can use the patient...

Page 40: ...Use only electrodes and contact agents recommended by GE Healthcare Placing the Electrodes This section describes the placement of the electrodes for 2 channel and 3 channel Holter ECG CAUTION PROPER...

Page 41: ...lor Coding IEC Color Coding AHA Color IEC Color Channel Location Red Green CH 1 Left anterior axillary line 5th rib White Red CH 1 Right manubrial border of sternum Brown White CH 2 Right border of st...

Page 42: ...ached and connected to the color coded leads AHA Color Coding IEC Color Coding AHA Color IEC Color Channel Location Red Green CH 1 Left anterior axillary line 5th rib White Red CH 1 Right manubrial bo...

Page 43: ...Independent ECG Channels To record 3 non independent ECG channels three electrodes are at tached and connected to the color coded leads AHA Color Coding IEC Color Coding AHA Color IEC Color Location...

Page 44: ...CONNECTOR AND RECORDER DAMAGE The cable can be connected to the recorder in one orientation only For correct orientation align the marks on connector and recorder as shown in the left graphic below D...

Page 45: ...or a rechargea ble battery which is not fully charged or aged may not last 7 days Before every recording the Event Button LED must be green If it flashes yellow once every second a new battery is nec...

Page 46: ...sh it into its bearings NOTICE RECORDER DAMAGE The Battery Compartment Door can be at tached to the recorder housing in one orientation only Attach the Battery Compartment Door as shown in the left gr...

Page 47: ...aged may not last 7 days Before every recording the Event Button LED must be green If it flashes yellow once every second a new battery is necessary NOTE If a previous recording is still stored in the...

Page 48: ...the Mi crosoft Windows App on page 90 The Apple iOS version of the application does not allow the recorder to be reset NOTE While the auto start function helps to prevent the patient from carry ing t...

Page 49: ...order to another patient Switching Off Before the Recording Duration Has Been Reached NOTE The only way to prematurely terminate a recording without using an app is to open the battery compartment to...

Page 50: ...power down completely Use a USB cable to connect the recorder to a PC containing ECG analysis and evaluation software As the recorders perform a series of internal tests after being switched on you ne...

Page 51: ...their representatives before entering their data into a database or viewing their medical data NOTICE SOFTWARE INTRUSION PCs and software delivered are scanned for viruses but can nevertheless be intr...

Page 52: ...duration of a recording Set the type of battery i e 1 5 V single use type or 1 2 V rechargeable type Display the battery status View patient demographic information stored in a recorder View the date...

Page 53: ...ssword Recorder Data Protection Once communication with a recorder has been established using an app a protection key which is automatically generated from the administrator password is downloaded to...

Page 54: ...emographic data to a recorder before starting a recording If the CardioDay administrator also has the same password as the app admin istrator then the ECG technicians may use their apps to communicate...

Page 55: ...uetooth wireless technology try one of the following measures Do not position the devices closer than 50 cm 19 7 inches to each other or more than 10 m 10 9 yards from each other Remove any objects fr...

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Page 57: ...ian Password on page 61 Installing and Setting up the App The following Apple products running iOS 6 or greater are supported iPhone 5 iPhone 4S iPhone 4 iPad 4rd and 3th generation iPad mini iPad 2 a...

Page 58: ...replace it with your new password NOTICE UNAUTHORIZED ACCESS TO THE RECORDER The administrator pass word is used to secure the recorder from unauthorized access Change the password whenever necessary...

Page 59: ...d Technician or Reset Technician Password Only the app administrator can create Technician IDs and reset pass words to the default password To create a new Technician ID 1 Touch Add Technician 2 Enter...

Page 60: ...ight of the technician entry 3 Touch Reset Password The password of this technician is reset to the technician default password 20130114 4 Touch Save 5 Touch Logout to return to the Technician Login s...

Page 61: ...013 3 Touch Continue Starting the App and Changing the Technician Password NOTE Verify that your iOS device has Bluetooth enabled On your Apple de vice open Settings select Bluetooth and verify that i...

Page 62: ...ering and confirming your new password Your new password must be at least eight characters long Patient Hookup If you have prepared the recording as explained in the Preparing the Re cording section o...

Page 63: ...ting a patient you will be taken to the Find Device screen 1 If the recorder is not turned on press the Event Button until you hear a beep to switch on the recorder 2 Touch Find Device The recorder id...

Page 64: ...the connec tions only Do not use these preview waveforms for diagnostic purposes CAUTION SIGNAL QUALITY If there is a severe muscle interference or artifact on the ECG when you tap the top of the ele...

Page 65: ...each channel To zoom in on a channel or to zoom out again double tap the respective waveform Verify or Change Settings The Apple iOS app allows you to verify or change both the battery type and record...

Page 66: ...f the recorder The default setting of the recorder is Autodelete On If this is changed the application detects it To automatically delete recordings after they are read into the Holter analysis system...

Page 67: ...ot with the minus sign to the left of the patient entry Then touch the Delete button that is dis played to the right of the entry To edit a patient entry touch the blue arrow to the right of the en tr...

Page 68: ...ds until a multi beep sounds Touch Find Device to pair new recorders to the app If you select the recorder in the list you can o view the Hookup screen while a recorder is recording o view patient dat...

Page 69: ...of the SEER 1000 Mobile Application can only be performed with suited hardware The personal computer PC used must comply with the most recent version of the international standard IEC 60950 Hardware S...

Page 70: ...ivated How to Disable a Built in Bluetooth Module If your computer has an internal Bluetooth module it must be deactivated before the supplied Bluetooth USB Adapter is connected Ask your system admini...

Page 71: ...ed If all previous settings need to be removed follow the Reset Application procedure described later in this chapter Changing the Administrator Password The app is password protected to avoid uninten...

Page 72: ...the Default Administrator Password 14012013 3 Replace the Default Administrator Password by entering and setting your new password Your new password must be at least eight characters long Add Technici...

Page 73: ...ng steps 1 Log in as administrator Touch Administration in the upper right corner and enter the ad ministrator password 2 Select the technician in the list 3 Click the U symbol to open the Edit Techni...

Page 74: ...Administration screen 2 Enter the Default Administrator Password 14012013 3 Click Login 4 Confirm the prompt Starting the App and Changing the Technician Password NOTE Verify that the external Blueto...

Page 75: ...R 1000 75 2 Enter the ID that has been set up for you by your administrator 3 Enter the default password 20130114 4 Click Login 5 Replace the default password by entering and setting your new password...

Page 76: ...dd or Select a Patient Connect to the Recorder 1 Click the I symbol to add a new patient 2 Enter the patient demographic data You have to enter at least the Patient ID Use the tab key to skip between...

Page 77: ...c onds to several minutes depending on the number of Blue tooth devices in the area and on other electronic conditions 7 Click Cancel after the message Searching for new device has changed to Number n...

Page 78: ...or artifact on the ECG when you tap the top of the electrodes lightly or when the patient moves it is possible that the electrodes are not attached properly To increase the accuracy of analysis make...

Page 79: ...ngs The app allows you to verify or change both the battery type and record ing duration Select Standard or Rechargeable Battery To get an accurate battery life reading identify the type of battery be...

Page 80: ...set Autodelete to On To manually delete recordings after they are downloaded into the Holter analysis system set Autodelete to Off Start the Recording Click the start button at the top of the screen...

Page 81: ...o the patient list o Click Add Next Patient to add more patients to the list Devices Tab In the Devices tab you can connect to a recorder while it is recording or after having finished NOTE If the rec...

Page 82: ...rding o view patient data recorder serial number cable serial number recorder time battery level o stop and delete existing recordings or delete patient information stored on the recorder and o start...

Page 83: ...ry second An error tone sounds when you try to start the recording Battery power is low The battery is not fully charged or the wrong battery type has been inserted Replace with new alkaline battery o...

Page 84: ...g green during specified record ing duration The recording has stopped before the specified record ing duration has been reached The recording may have been started with a low battery Download or dele...

Page 85: ...e the recording duration Battery low Recorder is shutting down Insert a new alkaline or a fully charged NiMH battery Data could not be deleted Please check if the SEER recorder is connected to another...

Page 86: ...he app 2 Call up the Apple iOS Settings menu 3 Select the Bluetooth tab 4 Select the Forget this device op tion 5 Select the recorder 6 Repeat the pairing process for this recorder Recorder is recordi...

Page 87: ...in the app and the patient has not been automatically deleted from the list after the start of the re cording In this case go to the Pa tients tab and delete the patient manually If the recording is...

Page 88: ...administrator pass word are no longer accessible until the data has been downloaded and deleted NOTE If the recorder has started auto matically or has been manually started using the Event Button a p...

Page 89: ...or more than 10 m ap prox 11 yards from each other The app device s Bluetooth connectivity is not enabled Verify that your device s Blue tooth connectivity is enabled Objects between recorder and app...

Page 90: ...ows system administrator You can try the following Check if Bluetooth is enabled on the recorder and try again If a recording is running press and hold the Event Button until the multi beep indicates...

Page 91: ...vice if the Recorder is Defective If the recorder is defective it will be detected during the self test when the recorder is switched on In case a defect is detected during the self test the following...

Page 92: ...ammed 2 The internal RAM is defective or has a soldering problem 3 One or more of the different internal clocks fails 4 The communication between the C and the NAND Flash fails 5 The NAND Flash has to...

Page 93: ...ty Use cleaning and disinfection agents only in accordance with the manufacturer s instructions and especially be sure to use the correct dilution factor given in these instructions Wring excess disin...

Page 94: ...rve the following guidelines when cleaning the recorder Remove the battery before cleaning the recorder Clean the device before performing surface disinfection Use a lint free cloth slightly moistened...

Page 95: ...ir life and protect patients Proper cleaning and disinfecting prolongs the life of the cables and leadwires Failure to use the proper cleaning solutions or to follow the proper procedures can result i...

Page 96: ...chlorine and maxi mum 1 10 dilution Any sodium hypochlorite wipe product that meets the previ ous guidelines 3 Dry the cables with a clean cloth or paper towel Storing ECG Cables Store cables and lead...

Page 97: ...channels Recording time 24 hours 48 hours or 7 days depending onmodel Lead off detection Yes Defibrillator Proof No Connectors One connector for ECG and USB combined LEDs Event Button LED Hookup Guida...

Page 98: ...Hz 12 bit 2 93 V Input voltage range ECG 6 mV Common mode rejection CMR 80 dB per channel Input impedance 10 M Mechanical Component Description Dimensions Height 63 mm 2 48 inches Width 70 mm 2 75 inc...

Page 99: ...ndensing Ambient pressure 106 to 50 kPa Storage temperature 20 to 65 C 4 to 149 F Storage humidity 5 to 95 relative humidity non condensing Bluetooth module Component Description Transmission technolo...

Page 100: ...omagnetic environment guidance RF emissions CISPR 11 Group 1 The device uses RF energy only for its internal function There fore its RF emissions are very low and are not likely to cause any interfere...

Page 101: ...applicable Mains power quality should be that of a typi cal commercial or hospital environment Voltage dips short inter ruptions and voltage vari ations on power supply input lines IEC 61000 4 11 5 U...

Page 102: ...Field strengths from fixed RFtransmitters as determined by an electromagnetic site surveya should be less than the compliance level in each frequency range b Interference may occur in the vicinity of...

Page 103: ...ipment Rated maximum output power of transmitter W Separation distance according to frequency of transmitter m 150 kHz to 80 MHz P 1 2 d 80 MHz to 800 MHz P 1 2 d 800 MHz to 2 5 GHz P 2 3 d 0 01 0 12...

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Page 105: ...28 E electrode placement 40 equipment identification 26 I illustration conventions 29 indications for use 10 intended user 10 L label locations 25 product 26 M manual purpose 28 N notes 30 P package...

Page 106: ...manufacturer 19 S safety conventions 11 hazards 11 information 10 serial number format 27 service information 27 requirements 27 signal reproduction accuracy of 17 skin preparation 39 supplies 19 sym...

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Page 108: ...558 7044 US Only Fax 1 414 355 3790 Distributor European Headquarters GE Medical Systems Information Technologies GmbH Munzinger Str 5 79111 Freiburg Germany Tel 49 761 45 43 0 Fax 49 761 45 43 233 D...

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