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Introduction

2067634-131 Revision E

SEER ™ 1000

11

Regulations and safety information

This section contains information on the safe use of this system and compliance with legal
requirements. Familiarize yourself with this information, and read and understand all instructions
before attempting to use this system. The system software is seen as a medical software. As
such, it was designed and built in accordance with the relevant regulations and health controls.

NOTE

Failure to follow the safety instructions is regarded as improper use of this system and
can cause injury, loss of data or void the warranty.

The meaning of the signal words

A risk is defined as a source of potential injury to a person or damage to property.

The terms "Warning", "Caution" or "Warning" are used in this manual to indicate the risk and
severity of a threat. Familiarize yourself with the following settings:

Definition of signal words

Signal word

Definition

DANGER

It indicates an immediate risk that, if not avoided, could result in
death or serious injury. (Not used in this instruction manual.)

NOTICE

indicates a potential hazard or unsafe practices which, if not
avoided, could result in death or serious injury.

CAUTION

indicates a potential hazard or unsafe practices which, if not
avoided, could result in minor or moderate injury.

ATTENTION

indicates a potential hazard or unsafe practices which, if not avoided,
could result in damage to the product or other property, and loss of
data.

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Содержание SEER 1000

Страница 1: ...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 ...

Страница 2: ... 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 ...

Страница 3: ...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 in...

Страница 4: ...s 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 4 Measures after...

Страница 5: ...ion 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...

Страница 6: ...th 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 9 Maintenance 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 Di...

Страница 7: ...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 ...

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Страница 9: ...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 ...

Страница 10: ...re 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 reco...

Страница 11: ...ignal words A risk is defined as a source of potential injury to a person or damage to property The terms Warning Caution or Warning are used in this manual to indicate the risk and severity of a threat Familiarize yourself with the following settings Definition of signal words Signal word Definition DANGER It indicates an immediate risk that if not avoided could result in death or serious injury ...

Страница 12: ...o a diagnosis incorrectly assigned Be especially careful to always select the correct recording and the right patient Between in case of digital management of patients where the patient ID or enter the patient ID in the door data to ensure that a recording is not assigned to the wrong patient NOTICE ELECTROSURGERY There is a risk of burns and damage to the patient When an electrosurgical instrumen...

Страница 13: ...tice of patient care Proceed in all circumstances in accordance with good medical practice NOTICE DANGER OF CONTAMINATION OR INFECTION The recorder and its accessories may be contaminated with bacteria or viruses after use When the recorder is contaminated in some way observe the standard procedures for handling contaminated objects and the following precautions O Wear gloves when touching the obj...

Страница 14: ...ygienic reasons in particular to protect our personal assistance service before sending them back for inspection or maintenance INDICATIONS OF ATTENTION ATTENTION Damage to the cable the cable can be damaged if it is bent strongly curved or curled When placing and connecting the ECG cable ensure that it can not be damaged Never wrap the cord around the burner The correct handling is explained in s...

Страница 15: ... a patient ATTENTION A malfunction or damage in the unit Changes in temperature or humidity may cause condensation in the burner Wait at least two hours beyond the visible drying outside the recorder to use it again ATTENTION MACHINE DAMAGE On the recorder only can open the battery compartment Do not apply in any way force the recorder ATTENTION ONLY WITH SAFETY ACCESSORIES APPROVED A safe and rel...

Страница 16: ...ecorder and ECG cables are needed to find the faults and repair them For service or repair to the unit always send also the ECG cable used Not wrap the cord around ECG recorder as this may damage the cable Use a tape recorder to always the same ECG cable Note that when multiple recorders are available in a facility that a recorder is always in conjunction with a specific ECG cable Thus errors can ...

Страница 17: ...can reduce the signal quality Do not use the recorder with an electric blanket Medical Device Classification The device is classified as follows according to IEC 60601 1 Medical Device Classification Category ranking protection against electric shock Degree Type CF application component not protected defibrillator Protection against ingress of dust and water The recorder s protection class is IP43...

Страница 18: ...ss of the first pulse flank is less than 10 Playback of all pulses of a triangular pulse sequence of 1 5 mV 40 ms which simulates a next series of R waves is within 80 to 110 reproduction of a sequence of triangular pulse 1 5 mV 200 ms Warning EMS CEM AF The system was designed and tested to meet the requirements for electromagnetic compatibility EMC System changes or additions to this system not ...

Страница 19: ...Reference Manual of spare parts and accessories for your system O Or authorized representatives GE Healthcare GE Healthcare O Or authorized representatives GE Healthcare GE Healthcare O Annex on electromagnetic compatibility in this manual O Annex on electromagnetic compatibility in this manual instructions biocompatibility The system components described in this manual including accessories that ...

Страница 20: ... where the labels used on your device and its packaging First the symbols used on the labels are explained symbols The following symbols can be found on the device and system packaging To become familiar with the meaning of these symbols you are ensuring a safe use and disposal of the equipment The meaning of the symbols not listed here are the information of the original equipment manufacturer OE...

Страница 21: ...d address of the manufacturer of the appliance Manufacturing date year Refers to the original date of manufacture of this device Application Component type CF It features a CF application component type in a medical device which corresponds to the IEC 60601 1 standard This device complies with electric shock protection requirements for a floating application component floating which is intended fo...

Страница 22: ... 60 to the vertical ATTENTION The DEGREE OF PROTECTION IS LIMITED TO THE FOLLOWING CONDITIONS IP43 only applies if the battery cover is closed and locked and the ECG cable is connected properly to the recorder Before starting recording make sure that the battery cover is closed and locked and that the ECG cable is connected properly to the recorder CAUTION SEE THE ATTACHED DOCUMENTS There may be s...

Страница 23: ...m contains electrical or electronic components that must not be disposed of with household waste but separately You can get information about the disposal of your device from an authorized representative of the manufacturer Rx Only Rx Only In the US a national law only allows the appliance to be used by a physician or under his order period of use compatible with the environment Environment Friend...

Страница 24: ...ne should not stack more than 5 product packages and that you should not put any weight on top of the upper package Do not stack Stresses that one should not stack the product packages and you should not put weight on the package Protect from moisture It indicates that it should protect the rain product packages and other sources of moisture humidity limits Refers to the upper and lower limit of h...

Страница 25: ...lications and AUTHORIZATIONS for industrial scientific and medical ISM equipment requirements for industrial scientific and medical applications TÜVRheinland Indicates that the test of the TÜV Technical Inspection Association the device or the product complied with the technical requirements and applicable safety disposable alkaline battery This symbol is selected in the SEER 1000 applications whe...

Страница 26: ...ale patients Delete This symbol is used in applications to delete a patient or a technician Continue This symbol is used in Microsoft Windows application to call the next step Modify This symbol is used in Microsoft Windows application to change patient data or technical Search for This symbol is used in Microsoft Windows application to search for a writer to the wireless connection Event button B...

Страница 27: ...ed explanations section symbols On page 20 are more detailed explanations Label Local description 1 Rear apparatus See Rating plate on the See Rating plate on the See Rating plate on the page 28 2 Packing Information expedition Product Designation Serial number Compliance with the authorities devices manufacturer and distributor information 3 Packing Information handling and safety as well as the ...

Страница 28: ...ame information In the section symbols On page 20 are more detailed explanations In the section symbols On page 20 are more detailed explanations In the section symbols On page 20 are more detailed explanations Object description SEER 1000 Model 24 Hour Recording duration Distributed by distributed GE Medical Systems Information Technologies Inc Canada Private Label Manufacturer GE Medical Systems...

Страница 29: ...of device fabrication Values between 00 and 99 For example 13 2013 3 product sequence A five digit code that represents the sequence of production of the devices of this model Values between 00101 and 99999 Information about maintenance This section contains information about maintenance and system care Familiarize yourself with this information before charge GE Healthcare or authorized representa...

Страница 30: ...to answer your questions and to respond to problems that arise during installation maintenance and use of this product If you need further assistance contact your local GE Healthcare representative Information on this instruction manual In this section are information about the proper use of this manual Always keep this manual near the equipment and read it carefully If necessary should request as...

Страница 31: ...sed and released then For example C Press TRL AND SC To press the C key TRL and hold and then press Press TRL AND SC To press the C key TRL and hold and then press Press TRL AND SC To press the C key TRL and hold and then press Press TRL AND SC To press the C key TRL and hold and then press Press TRL AND SC To press the C key TRL and hold and then press Press TRL AND SC To press the C key TRL and ...

Страница 32: ...stem 2 Select from the menu System settings to Select from the menu System settings to Select from the menu System settings to open the menu Settings open the menu Settings 3 Select from the menu Settings options Select from the menu Settings options to open the window Activation of the option to open the window Activation of the option Illustrations All illustrations in this manual serve only as ...

Страница 33: ...ders can record long term ECG with 2 or 3 channels The number of channels depends on the recorded ECG cables used The recorders automatically detect pacemaker pulses without the need and entries To exchange data wirelessly with an external recorder there are external Apps for both Apple iPad iPod or iPhone as well as a standard PC with a Microsoft Windows operating system Both Apps are used for th...

Страница 34: ...t of buttons 3 combined ECG cable connection and USB cable connection 3 combined ECG cable connection and USB cable connection 3 combined ECG cable connection and USB cable connection 3 combined ECG cable connection and USB cable connection 3 combined ECG cable connection and USB cable connection 4 LED of electrodes 4 LED of electrodes 5 Battery compartment 5 Battery compartment 6 battery compartm...

Страница 35: ...n It is pressed while recording is activated the wireless connection to the App Start a recording without the use of an application Press the button and release it A double beep confirms that recording has started During recording select an event Press the button and release it An acoustic signal confirms that the event was logged Enable wireless connection to the App Press and hold the button for...

Страница 36: ... On inform the service that the recorder is faulty On page 109 are more detailed explanations quickly flashes alternately in green and yellow LED of electrodes Before recording this bicolor LED indicates the respective state of the electrodes State of electrodes Indication LED Electrodes connected correctly illuminated in green electrodes loose Except for the electrode for grounding flashing yello...

Страница 37: ...tically as follows state ringer tape recorder simple acoustic signal recording began Double acoustic signal The recording can not be started Eg due to low battery or because the ECG cable is not connected Three serious acoustic signals event marked by pressing the Event button event marked by pressing the Event button simple acoustic signal Wireless connection to the App is activated Effect of aco...

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Страница 39: ...n in step 6 you can use one of Apps to enter patient data and verify signal quality We recommend recording prepare the following steps explained in detail below Each step is explained in more detail in the following sections 1 Explain to the patient the necessary precautions and recording protocol 2 Prepare the patient s skin 2 Prepare the patient s skin 3 Apply the electrodes on the patient 3 App...

Страница 40: ...der in her purse and in the case of unfavorable weather conditions wear it under a jacket Do not expose the recorder to extreme temperatures The operating temperature of the burner should not exceed 45 C even be below 5 C In case of different climatic conditions remains in the temperate areas as possible and place the recorder under clothing if it gets cold To protect the burner against temperatur...

Страница 41: ... to the patient that he should briefly press the Event button during recording to mark Explain to the patient that he should briefly press the Event button during recording to mark Explain to the patient that he should briefly press the Event button during recording to mark a patient event A second tag can be used to mark the end of an event The doctor may use patient events to evaluate the ECG se...

Страница 42: ...ake sure that the conductive parts of electrodes wires do not come into contact with any other conductive parts 5 See if the LEDs electrodes indicate any problems 5 See if the LEDs electrodes indicate any problems 5 See if the LEDs electrodes indicate any problems 5 See if the LEDs electrodes indicate any problems electrodes NOTE Only use electrodes and adhesive materials recommended by GE Healthc...

Страница 43: ...t colors to record an ECG three channels color coding AHA Color coding IEC AHA colors IEC color Channel Position Red Green 1 front left axillary line fifth rib White Red 1 manubriosternal right edge right of the sternum Brown White 2 Right edge of the sternum fourth rib black Yellow 2 The left edge of the sternum Orange Orange 3 The left edge of the sternum the fourth intercostal space Blue Blue 3...

Страница 44: ...rent colors to record an ECG two channels color coding AHA Color coding IEC AHA colors IEC color Channel Position Red Green 1 front left axillary line fifth rib White Red 1 manubriosternal right edge right of the sternum Brown White 2 Right edge of the sternum fourth rib black Yellow 2 The left edge of the sternum Green black Earth bottom edge of right rib cage in bone ...

Страница 45: ...ecord ECG three non independent channels three electrodes are placed and connected with wires of different color AHA Color Coding IEC Color Coding Color AHA Designation Color IEC Designation Position White Red manubriosternal right edge right of the sternum black Yellow Right margin of the sternum seventh rib Red Green lower left thorax ...

Страница 46: ...ngs Control cable before connecting the electrodes ATTENTION DAMAGES IN CONNECTION AND RECORDER The plug ECG cable or USB download cable can only be inserted in a position recorder If the plug ECG cable or USB download cable is inserted incorrectly this could cause serious damage to the machine The damage caused by improper use are not covered The plug and the recorder are correctly positioned if ...

Страница 47: ...ttery or a fully charged battery is required A low quality cell and without an appointment or an accumulator that is not fully loaded could not last seven days Before each recording the LED event of buttons should be green If it flashes once Before each recording the LED event of buttons should be green If it flashes once Before each recording the LED event of buttons should be green If it flashes...

Страница 48: ...om the recorder housing To replace or replace the battery cover hold the cover as shown in the graph below left and press it into its compartment ATTENTION RECORDER DAMAGE The the battery cover It can only be inserted into the RECORDER DAMAGE The the battery cover It can only be inserted into the RECORDER DAMAGE The the battery cover It can only be inserted into the recorder in one position hold t...

Страница 49: ...button in the center of the recorder housing to start recording CAUTION SIGNAL QUALITY For the case that the ECG presents severe muscle tremors or artifacts when you lightly touch the electrodes or when the patient moves it may be that the electrodes are not fixed properly Attaching the electrodes correctly again ATTENTION RECORDING OF TIME COULD NOT BE REACHED To achieve the complete recording pe...

Страница 50: ...minutes The eight minutes of time period begins again each time that a wireless connection is established when the cable status changes eg if the cable is connected or disconnected or when the Event button It is pressed but recording does not start due to a low battery when the Event button It is pressed but recording does not start due to a low battery when the Event button It is pressed but reco...

Страница 51: ...ch time that a wireless connection is established when the cable status change for example if the cable is connected or disconnected or if the event button is pressed but recording can be started due to a low battery or due if the event button is pressed but recording can be started due to a low battery or due if the event button is pressed but recording can be started due to a low battery or due ...

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Страница 53: ...he use of an App a recording can only be terminated early if the battery is removed If the battery is removed before it was reached the recording time the recording ends at this point but it is however stored correctly For information about how to end a recording using an App see The tab Devices On page 78 For information about how to end a recording using an App see The tab Devices On page 78 For...

Страница 54: ...ion Connect the ECG cable to the recorder and the electrodes Page 46 and the electrodes Page 46 Since the recorder performs various internal tests one must wait until the Event button LED is Since the recorder performs various internal tests one must wait until the Event button LED is Since the recorder performs various internal tests one must wait until the Event button LED is highlighted in yell...

Страница 55: ...ired in writing by patients or their representatives before entering the data into a patient database or evaluate your medical data ATTENTION SOFTWARE VIRUS Systems and software are checked for viruses before delivery However they can be infected by viruses We recommend the following O Install a powerful antivirus scanning program and O Install a powerful antivirus scanning program and update it r...

Страница 56: ... secure wireless connection to a recorder transferring patient identification and demographic data to a recorder download the technical ID to a recorder display recorder settings set the duration of recording define the type of battery disposable battery of 1 5 V or accumulator Rechargeable 1 2 V display the battery status display on the recorder patient data stored display the date and time of th...

Страница 57: ...dministrator can enter one Technician ID and assign it to a technician ECG Only the administrator can enter one Technician ID and assign it to a technician ECG Only the administrator can enter one Technician ID and assign it to a technician ECG The ECG technician enters the default password specified in this user s manual and change it to your personal password After that only the administrator ca...

Страница 58: ...p used in the Reset iOS App Page 106 or in the Reset explanations are depending on the App used in the Reset iOS App Page 106 or in the Reset explanations are depending on the App used in the Reset iOS App Page 106 or in the Reset with Microsoft Windows App Page with Microsoft Windows App Page 107 Users of CardioDay CardioDay can also use CardioDay rather than an App to transmit patient data to th...

Страница 59: ...in the Using a Bluetooth adapter On page 82 a Bluetooth adapter On page 82 If Bluetooth connection interruptions try the following Keep a distance between the apparatus not less than 0 5 m and not more than 10 m Remove any objects from the line of sight between the two devices Remove any devices that may interfere with the radio transmission the proximity of the two devices Once the recorder is co...

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Страница 61: ...ts description in the App Store Install and launch the application 1 Tap the icon to open App Store Tap the icon to open App Store 2 look for the SEER 1000 Mobile App 2 look for the SEER 1000 Mobile App 2 look for the SEER 1000 Mobile App 3 tap Install tap Install 4 Tap the application icon to launch the application NOTE Make sure that Bluetooth is enabled on your iOS device Open on your Apple dev...

Страница 62: ...lways change the password if necessary for example if you have been advised to unauthorized persons NOTE Only the administrator can create Technical IDs or reset to the default password Only the administrator can create Technical IDs or reset to the default password Only the administrator can create Technical IDs or reset to the default password The application is always open with window Login The...

Страница 63: ... password tap Set a new administrator password Opens the window technician Opens the window technician Add technical or reset the password coach Only the application administrator can add Technical IDs and reset to the default password Only the application administrator can add Technical IDs and reset to the default password Only the application administrator can add Technical IDs and reset to the...

Страница 64: ...ication settings In the section Change the administrator password Page 62 is information relating to Change In the section Change the administrator password Page 62 is information relating to Change In the section Change the administrator password Page 62 is information relating to Change In the section Change the administrator password Page 62 is information relating to Change password Admin In t...

Страница 65: ... 130 114 The new password must be at least eight characters Then the technician can use the application To reset the password coach run as administrator the following steps 1 Log on as administrator tap Administrator in the upper right corner and enter the administrator tap Administrator in the upper right corner and enter the administrator tap Administrator in the upper right corner and enter the...

Страница 66: ...corner Administrator and enter the administrator password 2 In down menu bar on the screen select the menu config 2 In down menu bar on the screen select the menu config 2 In down menu bar on the screen select the menu config urações request 3 Enter the settings for the connection order interface WebAPI MUSE Contact the administrator of your MUSE website or service personnel of GE Healthcare for i...

Страница 67: ...changed when a recording request from this MUSE starts With the state of the application Open the application will continue to be displayed as a result when the function question Open the application will continue to be displayed as a result when the function question Open the application will continue to be displayed as a result when the function question order is again executed In this mode work...

Страница 68: ... technical IDs and passwords will erase all patient data stored in the application will erase all information stored recorder To reset the application 1 tap Reset the application in the window Administrator tap Reset the application in the window Administrator tap Reset the application in the window Administrator tap Reset the application in the window Administrator 2 Enter the Password manager St...

Страница 69: ...the function Save technical ID is enabled the App features in the field Technical ID the When the function Save technical ID is enabled the App features in the field Technical ID the When the function Save technical ID is enabled the App features in the field Technical ID the When the function Save technical ID is enabled the App features in the field Technical ID the When the function Save techni...

Страница 70: ...ding On page 39 you can use the guide Patient to start recording you can use the guide Patient to start recording you can use the guide Patient to start recording Once you have registered appears to guide Patient Once you have registered appears to guide Patient Select your patient and continue as explained in section Find device Page 74 Select your patient and continue as explained in section Fin...

Страница 71: ...e Page 74 tap Continue to continue as explained in section Find device Page 74 tap Continue to continue as explained in section Find device Page 74 tap Save to include this patient in the patient list tap Save to include this patient in the patient list tap Save to include this patient in the patient list tap Add next patient to add another patient tap Add next patient to add another patient tap A...

Страница 72: ...k in question order to open the applications list NOTE MUSE only are applications for long term ECG recordings to the state Open If no application MUSE only are applications for long term ECG recordings to the state Open If no application MUSE only are applications for long term ECG recordings to the state Open If no application meets this criterion the list will be empty ...

Страница 73: ...ually Page 71 Change or delete patient input NOTE The inputs of patients were collected from MUSE requests can not be changed so it is not presented any information icon near the entrance To change a patient input touch the Information icon shown on the right of the entrance Opens the window Edit patient in which realizes and shown on the right of the entrance Opens the window Edit patient in whic...

Страница 74: ...ecorder is not connected press the Event button until you hear a beep If the recorder is not connected press the Event button until you hear a beep If the recorder is not connected press the Event button until you hear a beep 2 tap Find device tap Find device The recorder s input is displayed in the window Select accessory The recorder s input is displayed in the window Select accessory NOTE It ma...

Страница 75: ...nd and paired successfully with App iOS it appears in the list of connected devices 4 Select the desired recorder from the list of connected devices to switch to the overview In the section Arrangement of electrodes and signal quality Page 76 the overview In the section Arrangement of electrodes and signal quality Page 76 the overview In the section Arrangement of electrodes and signal quality Pag...

Страница 76: ...s or if they result from the patient s movements it is possible that the electrodes are not properly protected To improve the accuracy of analysis ensure that the QRS complex channel displays a large amplitude If the amplitude is small the electrodes move to find a suitable position for arrangement of the electrodes The application shows the image of a torso with the layout of electrodes recommend...

Страница 77: ...Check or change the settings With the application you can select or change the type of battery and recording time Select a disposable battery or accumulator For an accurate indication of battery status select the icon in the lower left corner of the window if a disposable battery or accumulator is used disposable alkaline battery standardized NiMH battery Select the recording duration To select th...

Страница 78: ...ication detects when it has changed AutoDelete The application detects when it has changed To delete records automatically after being read into the analysis system select On To delete records automatically after being read into the analysis system select On AutoDelete To erase recordings manually after they have been read in the analysis system select Autodelete To erase recordings manually after...

Страница 79: ...corders to the application tap Find device to engage new recorders to the application If you select the list of the recorder you can O while recording ECG to view O while recording ECG to view O while recording ECG to view O while recording ECG to view O patient data the number recorder series the number O patient data the number recorder series the number cable series the time of the recorder and...

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Страница 81: ...ssword On page 87 Install and configure the application NOTICE POSSIBLE DISTURBANCES A safe and effective use of SEER 1000 Mobile Application is only possible with the appropriate hardware The PC used should correspond to the latest version of the international standard IEC 60950 Hardware Specifications The hardware used must meet the following minimum requirements Component Specification PRAÇA AT...

Страница 82: ... equipped with an internal Bluetooth module this must be turned off before the USB adapter is connected Consult your system administrator or do the following 1 Click the Windows field Start 1 Click the Windows field Start 1 Click the Windows field Start 2 click in Settings 2 click in Settings 2 click in Settings 3 click in System control and select manager 3 click in System control and select mana...

Страница 83: ...pen System control on the PC select Add and Remove To remove the PC application open System control on the PC select Add and Remove To remove the PC application open System control on the PC select Add and Remove Programs or Programs and resources and remove SEER 1000 Programs or Programs and resources and remove SEER 1000 Programs or Programs and resources and remove SEER 1000 Programs or Program...

Страница 84: ... The application is always open with window Login 1 If you start the application the first time you will be prompted to enter the default If you start the application the first time you will be prompted to enter the default administrator password This is necessary to create a new technical or technical reset passwords 2 Enter the default administrator password 14 012 013 2 Enter the default admini...

Страница 85: ... 4 click in to save to set the Technician ID and close the dialog 4 click in to save to set the Technician ID and close the dialog 4 click in to save to set the Technician ID and close the dialog 4 click in to save to set the Technician ID and close the dialog 4 click in to save to set the Technician ID and close the dialog 5 click in Cancel to return to the technical record 5 click in Cancel to r...

Страница 86: ...he technical record 6 click in Cancel to return to the technical record 6 click in Cancel to return to the technical record 6 click in Cancel to return to the technical record Reset the application If the administrator forgets the administrator password the system can be reset to the default settings ATTENTION The function Reset the application will erase all data and reset the application to the ...

Страница 87: ...strator password 14 012 013 2 Enter the default administrator password 14 012 013 3 click in Register 3 click in Register 3 click in Register 4 Confirm the query 4 Confirm the query Start the application and change the technician password NOTE Make sure that the external Bluetooth adapter is installed The application is password protected against inadvertent access the recorder By registering for ...

Страница 88: ...ing for recording On page 39 you can If you prepared the recording as described in the Preparing for recording On page 39 you can use the guide EKG to start recording use the guide EKG to start recording use the guide EKG to start recording Once you have registered appears to guide EKG Once you have registered appears to guide EKG Add or select a patient connect to a recorder 1 Click the symbol to...

Страница 89: ...ouble click the patient s name or click on the patient entry and then click the icon double click the patient s name or click on the patient entry and then click the icon 5 press Event button to turn on the recorder 5 press Event button to turn on the recorder 5 press Event button to turn on the recorder 5 press Event button to turn on the recorder 6 Click the symbol to start the device search 6 C...

Страница 90: ... sought 8 Double click on the recorder s input or click the entry 8 Double click on the recorder s input or click the entry the recorder and then click the icon the recorder and then click the icon By registering for the first time you will be asked to enter the PIN code 1234 or to confirm the PIN code that is displayed This is the prerequisite for a Bluetooth connection to this unit can be made I...

Страница 91: ...nsure that the QRS complex channel displays a large amplitude If the amplitude is small the electrodes move to find a suitable position for arrangement of the electrodes The application shows the image of a torso with the layout of electrodes recommended The system automatically detects the type of cable and shows the corresponding arrangement of the electrodes Double click the ECG curve or trunk ...

Страница 92: ...heck or change the settings With the application you can select or change the type of battery and recording time Select a disposable battery or accumulator For an accurate indication of battery status select the icon in the lower left corner of the window if a disposable battery or accumulator is used disposable alkaline battery standardized NiMH battery Select the recording duration To select the...

Страница 93: ...the analysis system select On AutoDelete To erase recordings manually after they have been read in the analysis system select Autodelete To erase recordings manually after they have been read in the analysis system select Autodelete Off Start recording Click the start symbol at the top of the window to start recording Click the start symbol at the top of the window to start recording Click the sta...

Страница 94: ...e two options To add a patient click the symbol and enter patient data Then you have two options To add a patient click the symbol and enter patient data Then you have two options O To save the recording of the patient and return to the list O To save the recording of the patient and return to the list patients click To save patients click To save O To add more patients to the patient list click O...

Страница 95: ...tion are not displayed before the recorder and the application being coupled for the first time Double click the device entry or click the device entry and then click the icon Double click the device entry or click the device entry and then click the icon If you select the list of the recorder you can O while recording ECG to view O while recording ECG to view O while recording ECG to view O while...

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Страница 97: ...art recording The voltage disposable battery or accumulator is too low The disposable battery is low or the battery is not sufficiently charged or a stack has been inserted wrong type Place a new disposable alkaline battery ouum sufficiently charged NiMH battery The LED electrodes The LED electrodes blink in yellow once per second An acoustic signal error if you try to start recording At least one...

Страница 98: ...ording was automatically stopped before reaching the duration of the scheduled recording Possibly the recording was started with a low battery Save or delete the recording and insert a new battery to start a new recording Make sure the machine is damaged Please contact the customer service center if the device is damaged At LED event keys At LED event keys and LED electrodes and LED electrodes fla...

Страница 99: ...e Apple iOS App NOTE If the administrator has changed your password no longer have access to their recorder which is protected by the old password until the data has been read or deleted NOTE If the recording was started automatically or manually with the button event is automatically generated a protection code by the recorder Wireless is not possible until the data has been read or deleted The p...

Страница 100: ...ysis software for example for example to read a record wait until the data transfer is completed Then you should disconnect the USB cable before trying again delete the data Error setting the recorder s password Try again Possibly the wireless connection has been broken Error setting the recording time Try again Possibly the wireless connection has been broken Error setting the cell type Try again...

Страница 101: ...the patient record manually If the recording is not running but the ECG waveforms are displayed LED event keys lit in green try to start recording again If the recording is not running and are not displayed ECG curves repeat the process and start by choosing the patient Error saving the setting to automatic cancellation Try again Possibly the wireless connection has been broken Error saving patien...

Страница 102: ...smission must be turned off On wireless data transmission must be turned off On page 82 Recorder SN can no longer be attached to this PC Want to repeat the coupling to this recorder Microsoft Windows message Select Yes The coupling is carried out automatically Technical ID not found The technician ID does not exist Please enter a valid technician ID There is already a technician with the same ID E...

Страница 103: ...at the coupling to this recorder Apple iOS Post 1 Close the application 2 Call the Settings menu 3 Select the Bluetooth tab 4 Select the Ignore this device option 5 Select the recorder 6 Repeat coupling to the recorder The data are stored on the recorder you wish to select a different recorder Erasing the data stored on the recorder or transfer them to a long term ECG analysis software You can als...

Страница 104: ...oth function of the device application is turned on Objects between the recorder and the application of the device damage the connection Remove all line of sight of the objects between the recorder and an application device AF Interference Device environmental harm the connection Remove any devices that emit interference AF vicinity of the recorder device and application After the start of recordi...

Страница 105: ...rks Try to enter the IP address of the MUSE system in the URL a wrong IP port was used to WebAPI MUSE The correct port number WebAPI service default 8100 must be part of the URL configuration Service WebAPI MUSE not active Ensure with the MUSE administrator or technical assistance from GE that WebAPI MUSE service is correctly configured and works without error The username or password do not match...

Страница 106: ... Bluetooth is turned on the recorder and try again If a recording being performed press and and hold the event button for approx 3 seconds until a series of beeps indicates that the wireless connection is enabled Disconnect on your Microsoft Windows device any embedded Bluetooth module Details can be found in the A module already installed for wireless data transmission must be turned be found in ...

Страница 107: ...he tab Patient 6 Switch to tab Devices 6 Switch to tab Devices 6 Switch to tab Devices 7 If the recorder that you want to perform a reset does not appear in the list click Search If the recorder that you want to perform a reset does not appear in the list click Search appliance 8 If the recorder that you want to perform a reset appears in the list click the information icon displayed on the screen...

Страница 108: ...rd the second line 5 click in Register 5 click in Register 5 click in Register Opens the tab ECG Opens the tab ECG 6 Switch to tab Devices 6 Switch to tab Devices 6 Switch to tab Devices 7 Select the recorder 8 If the recorder that you want to reset does not appear in the list click the symbol If the recorder that you want to reset does not appear in the list click the symbol 9 With the recorder y...

Страница 109: ...ne the type of that the LED event of keys flash green the support service personnel can determine the type of that the LED event of keys flash green the support service personnel can determine the type of defect The following table shows which defect is often indicated by a flashing LED Error number number frequency of blinking LED Error 1 The CRC Cyclic Redundancy Check self test firmware has not...

Страница 110: ...Problems solution 110 SEER 1000 2067634 131 Revision E ...

Страница 111: ...Moreover some substances are conductive or electrically insulating and may affect the signal quality Use only detergents and disinfectants according to the manufacturer s instructions Follow especially all the rules necessary for dilution Squeeze out excess disinfectant cloth before use Never immerse the appliance or the ECG cable ECG electrode lines in liquids This can lead to corrosion of the me...

Страница 112: ...vice cable lines and electrodes must never be sterilized by autoclaving or steam Do not use any of the accessories if they are not completely dry Clean and disinfect recorder Note the following for the recorder cleaning Remove the battery before cleaning the device Clean the device before disinfecting the surface For the external cleaning of the device use a cloth lint free lightly moistened with ...

Страница 113: ...system keep the cables and lines cleaned and disinfected electrodes This section provides instructions for cleaning disinfection and storage of cables and electrodes lines to extend its life and to protect patients The correct cleaning and disinfecting will prolong the life of the cables and lines of electrodes If the wrong cleaning agent is used or if the procedures are not respected this can cau...

Страница 114: ...for the selection and use of disinfectants Sodium hypochlorite domestic bleach 5 2 minimal dilution of 1 500 at least 100 ppm free chlorine and maximum dilution of 1 10 Any sodium hypochlorite solution that meets all the criteria of the directive 3 Clean the surfaces with a clean cloth or paper towel Storing ECG cable Always store the cables hanging them vertically in a dry well ventilated area Do...

Страница 115: ...ding on the type of cable connected pacemaker pulses Detection of pacemaker On all channels Recording duration 24 hours 48 hours or 7 days depending on the model Lead off detection Yes defibrillation protection No connections 1 ECG and USB connection combined LEDs Event buttons LED electrodes keys 1 key to on off as well as to mark patient events Time until the data is read Within a month ...

Страница 116: ...Component description Battery Type 1 x disposable alkaline battery LR03 AAA 1 5 V 1 x HR03 AAA 1 2 V NiMH battery 1000 mAh Replacement frequency range 0 05 to 70 Hz analog to digital converter 1024 Hz 12 bit 2 93 uV ECG data storage with 256 Hz 12 bit 2 93 uV ECG input voltage range 6 mV synchronization suppression CMRR 80 dB per channel Input Impedance 10 M mechanical Component description dimens...

Страница 117: ...ng operation 5 to 45 C Humidity during operation relative air humidity 10 to 90 non condensing Ambient pressure during operation 106 50 kPa Temperature during storage 20 to 65 C air humidity during storage relative air humidity 5 to 90 non condensing Bluetooth Module Component description Transmission process Bluetooth 2 1 EDR Class 2 reach Up to 10 m in open field Frequency range AF From 2400 to ...

Страница 118: ...ELECTROMAGNETIC ENVIRONMENT Policies AF emissions CISPR 11 Group 1 The device uses HF energy only for its internal function Therefore its HF emissions are very low and are not likely to suffer near electronic equipment due to interference AF emissions CISPR 11 Class B The SEER 1000 is exclusively intended for use in all establishments including domestic establishments and those directly connected ...

Страница 119: ... cables 1 kV for cable entry and exit Not applicable The supply voltage should correspond to the quality of a typical commercial or hospital environment Transient voltage Surges according to IEC 61000 4 5 Voltage of 1 kV between the external conductive external conductor Voltage of 2 kV between the external ground conductor Not applicable The supply voltage should correspond to the quality of a ty...

Страница 120: ...3 A m Not applicable If there are faults it may be necessary to place the device further away from sources of magnetic fields of power frequency or install magnetic shielding the magnetic field energy frequency must be measured at the designated installation location to ensure that it is sufficiently small NOTE UT is the mains alternating voltage before application of the test level ...

Страница 121: ...ess transmitters field is at all frequencies as an essay on site The less than CORRELATION LEVEL B Nearby devices marked with this than CORRELATION LEVEL B Nearby devices marked with this than CORRELATION LEVEL B Nearby devices marked with this symbol there is possibility of having interference AF quantities of radiated interference per IEC 61000 4 3 3 V m 80 MHz 2 5 GHz 3 V m NOTE 1 At 80 MHz and...

Страница 122: ...r of the communications equipment nominal power transmitter W protection distance according to frequency Transmission m 150 kHz to 80 MHz P 1 2 d d 80 MHz to 800 MHz P 1 2 d d 800 MHz to 2 5 GHz P 2 3 d d 0 01 0 12 0 12 0 23 0 1 00 37 00 37 0 74 1 1 17 1 17 2 34 10 3 69 3 69 7 38 100 11 67 11 67 23 33 For transmitters whose rated power is not specified in the above table the distance can be determ...

Страница 123: ......

Страница 124: ...y Fax 3790w 1414355 Distributor European Headquarters GE Medical Systems Information Technologies GmbH Munzinger Information Technologies GmbH Munzinger Str 5 79111 Freiburg Germany Tel 49 761 45 43 0 Fax 49 761 45 43 233 Distributor Asian Headquarters GE Medical Systems Information Technologies Inc Asia GE Information Technologies Inc Asia GE China Co Ltd No 1 Huatuo Road Zhangjiang Hi tech Park ...

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