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QT Medical QT ECG Recorder, Руководство пользователя

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QT Medical QT ECG Recorder Скачать руководство пользователя страница 9

8

"SERIAL NUMBER" : The 

manufacturer's serial number.

The PWR LED indicates the power 

and charging status.

The CON LED indicates the 

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 

ECG Recorder.

The REC LED indicates the 

recording status of the QT ECG 

Recorder.

The QT ECG Recorder

Symbol/Marking

Description

Содержание QT ECG Recorder

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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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