QT Medical QT ECG Recorder User Manual Download Page 33 | Manualshive

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Customer Service Support

1360 Valley Vista Dr., Suite 203
Diamond Bar, CA 91765 U.S.A.

TEL : +1 855-722-6006
FAX : +1 310-755-3108

[email protected]

www.qtmedical.com

For customer service support, please contact:

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Summary of Contents for QT ECG Recorder

Page 1: ...QT ECG RECORDER USER S MANUAL service qtmedical com 855 722 6006 O 310 755 3108 F Contact Us Version V3 R1...

Page 2: ...ocedures 26 4 1 Attaching the Electrode Strip 26 4 2 Connecting the QT ECG Recorder 27 4 3 Recording the ECG 29 Preventive Maintenance 29 5 1 QT ECG Recorder 29 5 2 QT ECG Electrode Strip 29 5 3 Wall...

Page 3: ...d cautions listed in this manual to ensure safe and reliable performance of the system The Electrode Strip is for one time use only Do not reuse To prevent transmission of infection or disease dispose...

Page 4: ...trip Disposable patented electrodes that are prepositioned on a self adhesive strip The QT ECG App Software that allows you to use your mobile device to operate the QT ECG recorder You can send the re...

Page 5: ...n near real time to enable review at a physician s office hospital or other medical centers 1 3 Intended Use The QT ECG System is intended to condition an electrocardiographic signal so that it can be...

Page 6: ...ssion The degree of protection provided by the enclosure from particulate matter and water First Number 2 indicates protection against object sized 12 5mm Fingers or similar objects Second Number 2 in...

Page 7: ...erence from the device is under limits approved by the NCC FCC ID is a unique identifier assigned to a device registered with the United States Federal Communications Commission IC ID is the product I...

Page 8: ...ation conditions temperature range REFERENCE NUMBER The reference number of product same as model number UDI data matrix barcode it is intended to assign a unique identifier to medical devices within...

Page 9: ...Bluetooth connection status of the QT ECG Recorder to the mobile computing device Rated direct current input supply voltage and current Power Button Press and hold for 5 seconds to turn on off the QT...

Page 10: ...Date of manufacture General warning sign Keep away from sunlight The QT ECG Electrode Strip Symbol Marking Description The same symbols as recorder will not be explained Lot No the manufacturer s lot...

Page 11: ...G Electrode Strip to contact any other conductive objects including the earth 2 1 6 Keep the device away from flammables such as nitrous oxide and anesthetic mixtures with oxygen and air 2 1 7 To prev...

Page 12: ...Strip other than those specified or provided by QT Medical could result in increased electromagnetic emissions or decreased electromagnetic protection of the QT ECG system and lead to improper functio...

Page 13: ...nt may affect the quality of signals recorded by the QT ECG system 2 2 13 Do not open the QT ECG Electrode Strip package until time of use If not stored properly the QT ECG Electrode Strip might dry o...

Page 14: ...e patient movement can lead to poor quality data 2 3 7 For optimal data collection the patient s skin should be free of oil and or lotions before placing the QT ECG Electrode Strip on the chest 2 3 8...

Page 15: ...14 Prior to Operation 3 1 Know your Unit Your package contains the following items A QT ECG Recorder B Quick Guide C Wall Charger Micro USB Cable D Sizing Guide Quick Guide PCA 500 A D B C Fig 3 1 a...

Page 16: ...15 The QT ECG Recorder can be used with the following a Electrode Strip packaged and sold separately a Fig 3 1 b...

Page 17: ...3 1 1a Warning Do not attempt to charge the Recorder and plug in the Electrode Strip at the same time Do not use any charger other than the one provided in the original case To avoid risk of product...

Page 18: ...o connect with the QT ECG Electrode Strip Connector Fig 3 1 2b D LED Indicators There are three LED indicators PWR CON and REC which indicate the device status Table 3 1 1a Operation of the LED Indica...

Page 19: ...ireless Technology Bluetooth 4 0 dual mode Operation frequency range 2 402 GHz 2 480 GHz BLE 2 402 MHz to 2 480 MHz BT LED PWR Power Status LED RGB CON Connection LED Blue REC Recording LED Amber Exte...

Page 20: ...the recorder Battery Replacement Not user replaceable Charging Indicator Soft white Low Battery Indicator Blinking green Shelf Life 6 months Note It is recommended to charge the device every 30 days...

Page 21: ...ge 399 mV Multichannel Crosstalk 15 uV CMRR 99 dB Noise Level 10 uV Overload Tolerance Up to 1 V Wireless Distance 10 m Bluetooth Transmission Rate 3 Mbps Standard Leads Acquired I II III aVR aVL aVF...

Page 22: ...g Relative Humidity 15 93 Non condensing Operating Atmospheric Pressure 700 hPa 1060 hPa Storage and Transport Temperature 25 70 C 13 158 F Storage and Transport Relative Humidity 10 93 Non condensing...

Page 23: ...electrodes are integrated into the self adhesive QT ECG Electrode Strip It is attached to the body and plugs into the QT ECG Recorder as shown in Figure 3 1 2a 3 1 2 QT ECG Electrode Strip Fig 3 1 2a...

Page 24: ...ars 1 5 year for aviation use Do not use it past the expiration date This medical grade AC to DC power adapter provides external isolation from AC mains Use the provided wall charger to charge your QT...

Page 25: ...ifferent sizes for adults For a layperson a cardiologist or ECG technician should determine the size of the Electrode Strip for you 3 1 4 Equipment Preparation Android iOS Warning Visually inspect the...

Page 26: ...est is clean dry and free from lotion or oil For males with dense hair on the chest shave the chest along the area indicated in the following illustration The patient should rest sit still or lie down...

Page 27: ...en the QT ECG Electrode Strip package Remove the release liner using the Attaching the Electrode Strip 4 1 2 With the adhesive side facing the patient place the strip on the patient s chest First posi...

Page 28: ...the Electrode Strip and all electrodes to ensure the attachments are secure 4 2 Connecting the QT ECG Recorder Connect the QT ECG Recorder to the Strip or Patient Cable by inserting the connector on t...

Page 29: ...recording when Power PWR is Green Connection CON is Blue and Recording REC is blinking Amber In a low humidity environment electrodes may dry up preventing adhesion to the skin If the electrodes have...

Page 30: ...larly inspect the QT ECG Recorder for damage such as warping or cracking If there is any damage do not use the QT ECG Recorder and contact QT Medical customer service The following sections describe h...

Page 31: ...does not work please contact QT Medical customer service Problem Unable to connect the QT ECG Recorder to the mobile device iPad Android tablet etc via Bluetooth Solution If Bluetooth is not connected...

Page 32: ...er service Problem One or more of the 10 electrodes 7 chest leads and 3 limb leads are damaged or missing out of the box Solution Do not use the Electrode Strip Contact QT Medical customer service Pro...

Page 33: ...ustomer Service Support 1360 Valley Vista Dr Suite 203 Diamond Bar CA 91765 U S A TEL 1 855 722 6006 FAX 1 310 755 3108 service qtmedical com www qtmedical com For customer service support please cont...

Page 34: ...t to the following two conditions 1 This device may not cause harmful interference and 2 This device must accept any interference received including interference that may cause undesired operation NOT...

Page 35: ...c interference and advice on how to avoid or minimize such interference Guidance for Electromagnetic Emissions Appendix B IC Statement Appendix C Advice for Electromagnetic Interference QT ECG system...

Page 36: ...2 kV line s to earth Mains power quality should be that of a typical commercial or hospital environment Interruptions and voltage variations on power supply input lines IEC 61000 4 11 5 UT 95 dip in...

Page 37: ...romagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol NOTE 1 At 80 MHz and 80...

Page 38: ...tance according to frequency of transmitter m 150 kHz to 80 MHz d 1 2 80 MHz to 800 MHz d 1 2 800 MHz to 2 5 GHz d 2 3 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23...

Page 39: ...012 IEC 60601 1 11 2015 EN 60601 1 2006 A1 2013 A12 2014 US deviation IEC 60601 2 25 2011 Electromagnetic Compatibility EMC Safety IEC 60601 1 2 2014 Electrode ANSI AAMI EC12 2000 R 2010 Battery IEC 6...

Page 40: ...the wireless QoS needed for safe and effective operation Functions and performance of the wireless data transmissions including data rate and data integrity A brief description of the recommended wir...

Page 41: ...dulation 8 DPSK PI 4 DQPSK GFSK Channel width 1 MHz Output power BR EDR Class 2 4 dBm BLE 10 dBm Sensitivity 0 1 BER at 88 dBm Antenna Chip Antenna Data Transmission Range 10 meters Data Rate 3 Mbps t...

Page 42: ...active 255 total Unlimited Device Address Privacy None Private device addressing available Max Data Rate 1 3 Mbps 1 Mbps via GFSK modulation Pairing Algorithm Prior to 2 1 E21 E22 SAFER P 256 Elliptic...

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