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QT Medical QT ECG Recorder User Manual

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

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

  • Page 2: Table Of Contents

    Prior to Operation 3.1 Know your Unit 3.2 Patient Preparation Operating Procedures 4.1 Attaching the Electrode Strip 4.2 Connecting the QT ECG Recorder 4.3 Recording the ECG Preventive Maintenance 5.1 QT ECG Recorder 5.2 QT ECG Electrode Strip 5.3 Wall Charger Troubleshooting 6.1 QT ECG Recorder...

  • Page 3: Important Warnings

    MR Unsafe! Do not expose the device to a magnetic resonance (MR) environment. Do not try to charge the QT ECG Recorder while it is connected to the Electrode Strip. Read this manual thoroughly before using the QT ECG system. For your safety,...

  • Page 4: Introduction

    (smartphone, tablet, etc.) via Bluetooth. A Bluetooth-enabled mobile device (not included) is required in order to operate the QT ECG Recorder. The Electrode Strip Disposable, patented electrodes that are prepositioned on a self-adhesive strip.

  • Page 5: Indication For Use

    1.2 Indication for Use The QT ECG System is intended to acquire, record and process an electrocardiographic signal so that it can be transmitted digitally via Bluetooth technology to a cell-phone or mobile device, then to a remote location.The QT ECG System is indicated for use on adult patients and pediatric patients age 18 –...

  • Page 6: Symbols

    1.6 Symbols The following symbols are used in this manual and on the product and/or packaging: The QT ECG Recorder Symbol/Marking Description FCC Declaration of Conformity mark. Certification mark employed on electronic products manufactured or sold in the United States which certifies that...
  • Page 7 Republic of China (Taiwan) which certifies that the electromagnetic interference from the device is under limits approved by the NCC. The QT ECG Recorder model Model Number: QTERD100 number. FCC ID is a unique identifier assigned to a device registered...
  • Page 8 The QT ECG Recorder Symbol/Marking Description “MANUFACTURER” : The name and the address of the manufacturer. UDI data matrix barcode: it is intended to assign a unique identifier to medical devices within the United States. Caution: Federal law restricts this device to sale by or on the order of a licensed medical practitioner.
  • Page 9 ECG Recorder. 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. The REC LED indicates the recording status of the QT ECG Recorder.
  • Page 10 The QT ECG Electrode Strip Symbol/Marking Description Lot No.: the manufacturer’s lot number or batch code. Do not reuse. Do not use if package is damaged. General warning sign. Keep away from sunlight. Date of manufacture. * The same symbols as recorder will not be explained.

  • Page 11: Safety Information

    2.1.7. To prevent potential transmission of infection or disease, the one-time use QT ECG Electrode Strip must be properly disposed of after each use. The QT ECG Recorder may be cleaned before usage. refer to the section “Preventive Maintenance” to find information about cleaning methods.

  • Page 12: Cautions

    2.1.12. To avoid strangulation and suffocation, use under adult supervision. 2.1.13. The summation of electrical current leakage when a QT ECG Recorder and a QT ECG Electrode Strip are in use and interconnected is at most 50 2.1.14.
  • Page 13 2.2.9. Do not attempt to autoclave or sterilize the QT ECG Recorder and its accessories. 2.2.10. Do not attempt to charge the QT ECG Recorder when it is connected to the QT ECG Electrode Strip. 2.2.11. The QT ECG Electrode Strip should be applied only to intact, clean skin (i.e., not over open wounds, lesions, infected, or inflamed areas).

  • Page 14: Note

    2.3 Note 2.3.1. Caution: Federal law restricts this device to sale by or on the order of a licensed medical practitioner. 2.3.2. The device does not require calibration. 2.3.3. Always use the latest version of the QT ECG App. 2.3.4. Before placing the QT ECG Electrode Strip on the patient’ s chest, locate the landmarks on the chest as described in the User’...

  • Page 15: Prior To Operation

    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 PCA 500 Quick Guide Fig. 3.1 a...
  • Page 16 The QT ECG Recorder can be used with the following: a. Electrode Strip (packaged and sold separately) Fig. 3.1 b...
  • Page 17 3.1.1. QT ECG Recorder (Main Device) The three-view diagram of the QT ECG Recorder is shown in Fig 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.
  • Page 18 5 seconds. The Power (PWR) LED indicator will turn solid green when the power is on. B. Micro USB Port : Used for charging the QT ECG Recorder with the wall charger (included) (Fig. 3.1.1b) C. Recorder Receptacle : Used to connect with the QT ECG Electrode Strip Connector (Fig.
  • Page 19 Table 3.1.1b Specification of the QT ECG Recorder Feature Specification Brand Name QT ECG Model Name PCA 500 Model Number QTERD100 72x68.02x18.60 mm (2.83 x 2.68 x Dimension 0.735 in) Weight 67 g Enclosure Material Polycarbonate Bluetooth 4.0 dual mode Operation frequency range: 2.402 GHz...
  • Page 20 Specification 17 hours of continuous use Battery Operating Time 24 hours of normal use (use: standby = 1:5) with new battery Connect the QT ECG Recorder to wall Battery Charging Procedure charger through the Micro USB port on the recorder...
  • Page 21 Feature Specification 6% maximum reduction 20 ms vs 200 Triangle Response ms triangle wave Filters Default off. Input Impedance 6.875 MΩ DC-offset Voltage +/- 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...
  • Page 22 Feature Specification Pacemaker Detection Operating Temperature 5~40°C; 41~104ºF Operating Relative Humidity 15% – 93%, Non-condensing Operating Atmospheric Pressure 700 hPa – 1060 hPa Storage and Transport Temperature -25~70ºC ; -13~158ºF Storage and Transport Relative 10% – 93%, Non-condensing Humidity Storage and Transport Atmospheric 700 hPa –...
  • Page 23 3.1.2. QT ECG Electrode Strip All 10 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. Fig. 3.1.2a Fig. 3.1.2b...
  • Page 24 Do not use it past the expiration date. 3.1.3. Wall Charger This medical-grade AC-to-DC power adapter provides external isolation from AC mains. Use the provided wall charger to charge your QT ECG Recorder. Only use 100-240 V wall-socket outlets. Warning : Do not use any external power supply such as a portable battery charger or PC to charge the QT ECG Recorder.
  • Page 25 MedNet EC-REP GmbH Borkstrasse 10, 48163 Muenster, Germany 3.1.4. Equipment Preparation 1. Charge the QT ECG Recorder fully before the first use. Warning : Visually inspect the QT ECG Recorder and all accessories before use. Do not use if any component appears damaged. For support contact service@qtmedical.com.

  • Page 26: Patient Preparation

    3.2 Patient Preparation Make sure the skin on the chest 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) for at least 5 minutes before taking an ECG recording.

  • Page 27: Operating Procedures

    Operating Procedures 4.1 Attaching the Electrode Strip Caution : Do not tug the cables attaching the external electrodes (RA, LA, LL) to the Electrode Strip. Keep the cables and the 3 external electrodes clear of the adhesive side on the Electrode Strip. 4.1.1.

  • Page 28: Connecting The Qt Ecg Recorder

    Connect the QT ECG Recorder to the Strip or Patient Cable by inserting the connector on the Electrode Strip or Patient Cable into the Recorder Receptacle on the QT ECG Recorder. Insert the connector firmly until it is fully attached (see Fig. 3.1.2a).
  • Page 29 Do not place the QT ECG Recorder directly on the body; place a piece of gauze under the Recorder to separate the device from skin. Press and hold the Power button for 5 seconds to turn on the QT ECG Recorder.

  • Page 30: Recording The Ecg

    The QT ECG Recorder should be gently cleaned before every use. To disinfect the QT ECG Recorder, dampen a soft cloth with isopropyl alcohol and gently wipe the Recorder.

  • Page 31: Troubleshooting

    Press and hold power button for 30 seconds. If still unable to turn off the QT ECG Recorder, please contact QT Medical customer service. Problem : Unable to connect the QT ECG Recorder to the mobile device (iPad, Android tablet, etc) via Bluetooth...

  • Page 32: Qt Ecg Electrode Strip

    Problem : Package or contents arrive opened or damaged out of the box Solution : Do not use the Electrode Strip. Contact QT Medical customer service. Problem : One or more of the 10 electrodes (7 chest leads and 3 limb leads)

  • Page 33: Customer Service Support

    Customer Service Support For customer service support, please contact: 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...

  • Page 34: Warranty

    During this warranty period, if a defect arises in the QT ECG Recorder, QT Medical will at its option, to the extent permitted by law, either (i)

  • Page 35: Appendix B. Ic Statement

    Appendix B. IC Statement This device complies with Industry Canada license-exempt RSS standard(s). Operation is subject to the following two conditions: (1) this device may not cause interference, and (2) this device must accept any interference, including interference that may cause undesired operation of the device. Le présent appareil est conforme aux CNR d’Industrie Canada applicables aux appareils radio exempts de licence.
  • Page 36 Guidance for Electromagnetic Immunity: QT ECG is intended for use in the electromagnetic environment specified below. The customer or the user of QT ECG should assure that it is used in such an environment. Electromagnetic Immunity test IEC 60601 test level Compliance level environment –guidance Floors should be wood,...
  • Page 37 QT ECG is intended for use in the electromagnetic environment specified below. The customer or the user of QT ECG should assure that it is used in such an environment. Electromagnetic environment – Immunity test IEC 60601 test level Compliance level guidance Portable and mobile RF communications equipment should...
  • Page 38 Recommended Separation Distances between Mobile RF Communications Equipment and QT ECG: QT ECG is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of QT ECG can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters).

  • Page 39: Appendix D. Compliance For Emissions And Immunity Standard

    Appendix D. Compliance for Emissions and Immunity Standard Standard Edition ISO 10993-10:2002/Amd 1:2006, Biological evaluation of medical devices - Part 10: Tests for irritation Biocompatibility and skin sensitization; ISO 10993-5:1999, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity. IEC 60601-1:2005+AMD1:2012 CSV/ COR1:2012, IEC 60601-1-11:2015,...

  • Page 40: Appendix E. Wireless Technology

    Appendix E. WIRELESS TECHNOLOGY This appendix covers the following topics: • A summary of wireless functions and specific wireless technology incorporated into the device including equipment or system specifications. • A summary of the operating characteristics of the wireless technology, effective RF radiated power output and operating range, modulation, specification of each RF frequency or frequency band of transmission, and bandwidth of receiving section.
  • Page 41 10 meters Data Rate 3 Mbps (typical 1.6 Mbps) Encryption Best effort Done by Bluetooth link layer. Moreover, the QT ECG Recorder uses sequence Data integrity check numbers to make sure no data are lost during bulk ECG data transfer.
  • Page 42 Bluetooth BR/EDR Bluetooth Low Energy Characteristic Prior to 4.1 4.1 onwards Prior to 4.2 4.2 onwards 79 channels with 1 MHz 40 channels with 2 MHz RF Physical Channels channel spacing channel spacing Discovery / Connect Inquiry / Paging Advertising Number of Piconet 7 (active) / 255 (total) Unlimited...

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