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2067634-077 Revision B

SEER™ 1000

Contents

Introduction...................................................................................................................9

Intended User.............................................................................................................. 10

Indications for Use ..................................................................................................... 10

Intended Use ............................................................................................................... 10

Contraindications ....................................................................................................... 10

Prescription Device Statement................................................................................ 10

Regulatory and Safety Information ....................................................................... 10

Safety Conventions ....................................................................................... 11

Safety Hazards............................................................................................... 11

Medical Device Classification ..................................................................... 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 Information ............................................................ 19

Equipment Identification .......................................................................................... 26

Product Label ................................................................................................. 26

Serial Number Format and Product Code ............................................... 27

Service Information ................................................................................................... 27

Service Requirements .................................................................................. 27

Warranty Information .................................................................................. 28

Additional Assistance ................................................................................... 28

Manual Information ................................................................................................... 28

Manual Purpose............................................................................................. 28

Document Conventions ............................................................................... 28

Related Documents ...................................................................................... 30

Содержание SEER 1000

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 8: ......

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 36: ......

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 56: ......

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 104: ......

Страница 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...

Страница 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...

Страница 107: ......

Страница 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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