Vitalograph BT12 ECG User Training Manual Download Page 1 | Manualshive

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ECG

BT12 ECG

User Training Manual

07657_3

file:///C:/Users/mike/Downloads/07657-3 (1)/07657_3.html

1 of 28

6/27/17, 1:41 PM

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Summary of Contents for BT12 ECG

Page 1: ...ECG BT12 ECG User Training Manual 07657_3 file C Users mike Downloads 07657 3 1 07657_3 html 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: ...est 99th Street Lenexa Kansas 66215 USA Toll Free 800 255 6626 Tel 913 730 3200 Fax 913 730 3232 E mail vitcs vitalograph com www vitalograph com Vitalograph Ireland Ltd Gort Road Business Park Ennis...

Page 4: ...ECG device 1 Preparing the ECG recording 2 Switching the ECG measuring unit on off 3 Electrode contact 4 Heart rate monitoring 5 ECG data transmission 6 Displays and signals 7 6 CLEANING INSTRUCTIONS...

Page 5: ...and or data and as such Vitalograph cannot be held responsible and the device will no longer be supported 1 1 Indications for use The BT12 hereafter referred to as the BT Device is a battery powered d...

Page 6: ...lectrodes If there is any externally visible damage or if the self test fails the device may no longer be used The ambient conditions specified in the technical data are to be complied with The ECG me...

Page 7: ...mended separation distance between the ECG measuring unit and devices which emit High Frequency radiation e g cell or mobile phones to ensure correct operation see Section 12 Technical Specifications...

Page 8: ...nge of each BT ECG device Furthermore any WLAN sender or receiver e g WLAN USB dongles for PCs should be placed more than 1 meter away from the BT12 and the BT receiver BT USB dongle for PCs respectiv...

Page 9: ...re missing or damaged do not use the device Contact the distributor or the manufacturer directly for replacement parts ATTENTION Packaging material can pose a suffocation danger Keep it away from chil...

Page 10: ...rding to the valid regulations of your country 5 3 Clip The device can be worn on the patient s clothing with the clip To fasten the device to clothing push the clip in a loop of clothing or on a belt...

Page 11: ...trodes can pose a suffication aspiration danger do not use without supervision on children under the age of 3 or mentally confused patients 5 5 Electrode position The following table provides an overv...

Page 12: ...nection is established with a monitor such as a PC running appropriate software the ECG measuring unit is paired to this monitor If the Bluetooth driver requests a PIN number during this pairing opera...

Page 13: ...contact by flashing the respective point on the display If one or more points flash check the contact of the corresponding electrode s and replace if necessary The ECG transmission begins when all el...

Page 14: ...nal transmission is interrupted until the electrode has been replaced or correctly attached The recording is not interrupted if one of the V leads comes loose If the measured heart rate is above or be...

Page 15: ...atteries 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 manufactu...

Page 16: ...ard on the cables For disinfection rub the cable off with a cloth soaked in Incidin Foam or Mikrozid AF Liquid Please refer to the specific manufacturers instructions for use prior to disinfecting CAU...

Page 17: ...ing obstacle If necessary carry out pairing again See section 17 Troubleshooting guide for pairing the BT12 for details on resolving all known issues Displaying too few channels for desired 12 channel...

Page 18: ...addresses of approved Vitalograph Service Agents or to arrange training please refer to the contact information at the start of this manual 10 CONSUMABLES AND ACCESSORIES Cat no Description 41384 2 x...

Page 19: ...erence EN 55011 EN 61000 4 parts 2 3 6 8 Degree of protection against penetration of water IPX3 Variants BT12 12 channel 3 leads acc to Einthoven 3 acc to Goldberger 6 Wilson leads Electrodes Standard...

Page 20: ...1000 4 2 6 kV contact 8 kV air 6 kV contact 8 kV air Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Electrical...

Page 21: ...ng of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not a...

Page 22: ...of the Essential Requirements Annex I via compliance with Annex II of the Medical Devices Directive as per Article 11 section 3a excluding point 4 of Annex II FDA Quality System Regulation QSR 21 CFR...

Page 23: ...e has been installed and used in accordance with the user manual Notwithstanding this clause the software is not warranted to be free of errors This Guarantee does not cover any faults caused by accid...

Page 24: ...e ovens fluorescent lighting wireless cameras or security systems baby monitors wireless speakers remote control toys wireless pointing devices wireless networking devices Wi Fi base station wireless...

Page 25: ...e batteries when the BT12 ECG device display battery symbol flashes or shows no more bars 1 Set Spirotrac line filter to the correct mains power frequency for the country location by opening Spirotrac...

Page 26: ...om the BT12 and the BT receiver BT USB dongle for PCs respectively Otherwise BT12 will lose data packets The user is responsible for ensuring that data transmission is not corrupted by too many wirele...

Page 27: ...L DRIVERS Uninstall any BlueSoleil entries from Control Panel Programs and Features as these will create a driver conflict Windows 7 Users Click on Start at the bottom left of the screen 1 Select Cont...

Page 28: ...another BT12 device that is also within range 10 Clinical risk safety impact information and rational for non generation of FSCA The potential reportability and potential for a Field Safety Corrective...

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