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Summary of Contents for Vitalograph BT12 ECG
- Page 1 07657_3 file:///C:/Users/mike/Downloads/07657-3 (1)/07657_3.html BT12 ECG User Training Manual 1 of 28 6/27/17, 1:41 PM...
- Page 2 07657_3 file:///C:/Users/mike/Downloads/07657-3 (1)/07657_3.html 2 of 28 6/27/17, 1:41 PM...
- Page 3 Ennis, Co. Clare, V95 HFT4, Ireland Tel: +353 65 6864100 Fax: : +353 65 6829289 E-mail: sales@vitalograph.ie www.vitalograph.ie Vitalograph Ltd. Hong Kong /China Unit 2001, Floor 20, Block A, New Trade Plaza, 6 On Ping Street, Shatin Hong Kong Phone: +852 2117 2678 Fax: : +852 2117 2679 E-mail: sales@vitalograph.cn...
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Page 4: Table Of Contents
Table of Contents DESCRIPTION OF THE VITALOGRAPH BT12 ECG Indications for use CONTRAINDICATIONS, WARNINGS, PRECAUTIONS AND ADVERSE REACTIONS MAIN COMPONENTS OF THE VITALOGRAPH BT12 ECG FEATURES OF THE VITALOGRAPH BT12 ECG GETTING THE VITALOGRAPH ECG READY FOR USE Unpack device... -
Page 5: Description Of The Vitalograph Bt12 Ecg
1. DESCRIPTION OF THE VITALOGRAPH BT12 ECG The BT12 ECG measuring unit is an active medical product and in connection with a receiving unit serves as a mains- independent, wireless ECG device which can be worn on the body for the following purposes:... -
Page 6: Contraindications, Warnings, Precautions And Adverse Reactions
07657_3 file:///C:/Users/mike/Downloads/07657-3 (1)/07657_3.html 2. CONTRAINDICATIONS, WARNINGS, PRECAUTIONS AND ADVERSE REACTIONS Read this User Training Manual carefully, it is a component of the device and must be available at all times. Only use the device for the described purpose (see Section 1.1). Please also observe the User Training Manual of the PC software used with the measuring unit PN 07402. - Page 7 07657_3 file:///C:/Users/mike/Downloads/07657-3 (1)/07657_3.html The ECG measuring unit, especially the electrodes and electrode cables, may only come into contact with healthy patient skin. Wear the ECG measuring unit on a piece of clothing or carry it in its pouch (accessory). While the ECG is recording, don’t make any changes to the electrodes or the device as this may result in faulty measurements.
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Page 8: Main Components Of The Vitalograph Bt12 Ecg
Refer to the appendix at the end of this User Training Manual for a troubleshooting guide on pairing the Vitalograph ECG. 3. MAIN COMPONENTS OF THE VITALOGRAPH BT12 ECG Figure 2 8 of 28... -
Page 9: Features Of The Vitalograph Bt12 Ecg
5.1 Unpack device Remove all components of the Vitalograph BT12 ECG device carefully from the packaging. Check them against the contents list to ensure that they are all present and check them for damage. If any are missing or damaged do not use the device. -
Page 10: Clip
07657_3 file:///C:/Users/mike/Downloads/07657-3 (1)/07657_3.html Figure 3: Opened battery compartment with inserted batteries The battery status for the activated device is visible on the battery icon at the bottom left of the screen. It is recommended to change the batteries when the display shows no bars and the battery icon flashes. In measuring mode, the ECG measuring unit is designed for between 9 to 13 hours of operation, depending on the type of batteries used. -
Page 11: Electrode Position
07657_3 file:///C:/Users/mike/Downloads/07657-3 (1)/07657_3.html Shave off any excess hair which could prevent good electrode contact The application positions (see section 5.5) must be clean and dry Remove the foil from the adhesive electrodes The electrodes may only be applied to healthy skin Do not use any electrodes past their expiration date or if the gel is dried out Make sure that electrodes are exchanged according to manufacturer specifications Press the electrodes firmly onto the patient’s skin at the corresponding places, depending on the desired lead... -
Page 12: Functional Check
Contact the distributor or manufacturer to have the device repaired or replaced, please refer to the contact information at the start of this manual. 6. OPERATING THE VITALOGRAPH BT12 ECG 6.1 Pairing the ECG device The first time a connection is established with a monitor such as a PC running appropriate software, the ECG measuring unit is paired to this monitor. -
Page 13: Preparing The Ecg Recording
07657_3 file:///C:/Users/mike/Downloads/07657-3 (1)/07657_3.html Refer to section 17. Appendix for a complete troubleshooting guide on pairing the ECG device. 6.2 Preparing the ECG recording Examine the ECG measuring unit and the electrode cable for externally visible damage. If any damage is noted, have the unit repaired or replaced before using it. -
Page 14: Displays And Signals
07657_3 file:///C:/Users/mike/Downloads/07657-3 (1)/07657_3.html automatically. With the monitor software, ECG data can be shown online on the PC. In addition, measured values can be saved and revised (not available in every monitor software version). Observe the user instructions for the respective monitor software. -
Page 15: Cleaning Instructions
Remove the batteries if storing the device for a long period of time without using it to avoid damage to the device. An annual service is recommended. Service and repairs should be carried out only by the manufacturer or by Service Agents specifically approved by Vitalograph. 7.2 Disposal The device must be taken to separate collection at the product end-of-life. -
Page 16: Cleaning And Disinfecting The Electrode Cable
07657_3 file:///C:/Users/mike/Downloads/07657-3 (1)/07657_3.html CAUTION: Never submerge the device in disinfectant or other liquids as it may cause damage to it. 7.4 Cleaning and disinfecting the electrode cable To clean the electrode cable, rub the cable off with a soft, moist cloth. Only use a mild cleaning agent to avoid damage. Make sure you don’t pull too hard on the cables. - Page 17 Afterwards, switch on the device again. If the error code is still present stop using the device and contact Vitalograph. The “Radio active” symbol does not The wireless connection cannot be Reduce the distance to the receiver appear on the display or disappears established or has been broken.
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Page 18: Customer Service
Service and repairs should be carried out only by the manufacturer or by Service Agents specifically approved by Vitalograph. For the names and addresses of approved Vitalograph Service Agents or to arrange training, please refer to the contact information at the start of this manual. - Page 19 13. CE MARK Marking by the symbol indicates compliance of the Vitalograph BT12 ECG to the Medical Devices Directive of the European Community. Such marking is indicative that the Vitalograph BT12 ECG meets or exceeds the following technical standards: 19 of 28...
- Page 20 07657_3 file:///C:/Users/mike/Downloads/07657-3 (1)/07657_3.html Guidance and Manufacturer’s Declaration – Electromagnetic Emissions The BT12 is intended for use in the electromagnetic environment specified below. The customer or the user of the BT12 should assure that it is used in such an environment. Emissions Test Compliance Electromagnetic Environment –...
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Page 21: Fda Notice
Medical Devices may be affected by cellular telephones and other personal or household devices not intended for medical facilities. It is recommended that all equipment used near the Vitalograph product comply with the medical electromagnetic compatibility standard and to check before use that no interference is evident or possible. If interference is suspected or possible, switching off the offending device is the normal solution, as is required in aircraft and medical facilities. -
Page 22: Declaration Of Conformity
15. DECLARATION OF CONFORMITY Product: Model 4130 Vitalograph BT12 ECG Vitalograph hereby ensures and declares that the above product associated with this user manual, is designed and manufactured in accordance with the following QMS regulations and standards: European Medical Devices Directive {MDD} 93/42/EEC, as amended. -
Page 23: Guarantee
(1)/07657_3.html 16. GUARANTEE Subject to the conditions listed below, Vitalograph Ltd. and its associated companies, (hereinafter called the Company) guarantee to repair or at its option replace any component thereof, which, in the opinion of the Company is faulty or below standard as a result of inferior workmanship or materials. -
Page 24: Appendix
Some Laptops or PC’s may have an internal built-in Bluetooth adapter. It should be possible to pair the BT12 ECG device to the computer without the need for the supplied external Startech USB BT adaptor dongle. Reference NOTE 1 on how to turn this On/Off. - Page 25 Reduce the distance between the patient and PC. During a recording, the radio symbol on the BT12 ECG device may flash or disappear from the BT12 display to indicate the wireless connection has been interrupted. Black bars may appear on the ECG recording. To resolve the issue,...
- Page 26 Bluetooth icon, there is no built-in Bluetooth adaptor on the computer so in this case, the external Startech Dongle must be used) Verify BT12 ECG device battery charge status. Replace the batteries when the BT12 ECG device display “battery symbol” flashes or shows no more bars.
- Page 27 07657_3 file:///C:/Users/mike/Downloads/07657-3 (1)/07657_3.html NOTE 2 – CONFIRM MICROSOFT DRIVERS ARE USED WITH BT ADAPTOR To confirm/check if these drivers are installed: Connect the Bluetooth adapter Open Windows Device Manager Expand the “Bluetooth Radios” tree node. There should be two drivers listed “Generic Bluetooth Radio” and “Microsoft Bluetooth Enumerator”...
- Page 28 Launch Spirotrac Pair ECG (Tools – Options – ECG – Add/Pair) Verify that BT12 ECG device serial number listed on the BT12 ECG device serial number label is the same as the BT12 device serial number listed in the device configuration field in Spirotrac Tools\Options\ECG.
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