QT ECG RECORDER USER’S MANUAL Version: V3-R9-03 Update Date: 07/31/2024 https://www.qtmedical.com

3.1 Know your Unit 14 4.1 Attaching the Electrode Strip 26 Appendix C. Advice for Electromagnetic Interference 33 Appendix D. Compliance for Emissions and Immunity Standard 37 Appendix E. WIRELESS TECHNOLOGY 38 Customer Service Support 41

• Caution: Federal law restricts this device to sale by or on the order of a licensed medical practitioner. • This device is not defibrillator-proof. • 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, follow the operating instructions and all safety measures, including warnings and cautions, listed in this manual to ensure safe and reliable performance of the system. • The Electrode Strip is for one-time...

Introduction This user’s manual provides information about the QT ECG system and instructions on how to use it. 1.1 System Description The QT ECG system is a hand-held, cordless 12-lead electrocardiograph (ECG) system with Bluetooth connectivity. The QT ECG system consists of 5 major components: The QT ECG Recorder Compact device that records 12-lead, resting electrocardiograms and transmits the recorded data to a mobile device (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,...

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 infants, children and adults. It is designed to be operated by adults in the home, or by healthcare workers in non-acute care clinical facilities (such as nursing homes, skilled nursing facilities), to record and transmit a 12-lead ECG and rhythm strip in near real-time to enable review at a physician's office, hospital...

The following symbols are used in this manual and on the product and/or packaging: Symbol/Marking Description FCC Declaration of Conformity mark. Certification mark employed on electronic products manufactured or sold in the United States which certifies that the electromagnetic interference from the device is under limits approved by the Federal Communications Commission. "REFER TO MANUAL” : Follow operating instructions. 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...

The WEEE symbol, indicating separate collection for WEEE-Waste of Electrical and Electronic Equipment. Non-ionizing radiation Bluetooth wireless technology incorporated. Non-ionizing radiation. Model Number: QTERD100 FCC ID: 2AIBAQTERD100 IC: 21780-QTERD100 NCC Declaration of Conformity mark. Certification mark employed on electronic products manufactured or sold in the 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 number. FCC ID is a unique identifier assigned to a device registered...

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. Rx Only - USA Caution: Federal law restricts this device to sale by or on the order of a licensed medical practitioner. Type CF is the most stringent classification, being required for those applications where the applied part is in direct conductive contact with the heart or other applications as considered necessary. Storage and transportation conditions: humidity range. Storage and transportation...

SN "SERIAL NUMBER" : The manufacturer's serial number. Input5Vdc___1A Rated direct current input supply voltage and current. Power Button: Press and hold for 5 seconds to turn on/off the QT ECG Recorder. PWR The PWR LED indicates the power and charging status. The CON LED indicates the Bluetooth connection status CON of the QT ECG Recorder to the mobile computing device. REC The REC LED indicates the recording status of the QT ECG Recorder.

The QT ECG Electrode Strip Symbol/Marking Description Lot No.: the manufacturer’s lot number or batch code. General warning sign. Keep away from sunlight. * The same symbols as recorder will not be explained.

Make sure you are familiar with the safety information in this section before using the QT ECG system. Pay attention to all warnings and cautions to avoid personal injury and/or equipment damage. Indicates a potentially hazardous situation which, if not avoided, could result in personal injury. Indicates a potentially hazardous situation which, if not avoided, may result in damage to the equipment or other property. 2.1.1. Inspection: Visually inspect the QT ECG system and all accessories to use. Do not use if any COMPONENTS ARE DAMAGED. 2.1.2. The QT ECG system is not defibrillator-proof. Remove...

2.1.10. The QT ECG Electrode Strip is for one-time use only. Do not reuse. 2.1.11. Once the data has been collected, remove the QT ECG Electrode Strip right away. Prolonged use of the QT ECG Electrode Strip may cause allergic reaction or skin irritation. Contact your doctor if you have an allergic reaction or if skin irritation persists. 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 uA. 2.1.14. Remove the device if it...

2.2.5. Only use the QT ECG Recorder with compatible firmware as specified in the User's Manual. 2.2.6. Follow the User's Manual when connecting the device to its components. Ensure all accessories and the device are properly connected. 2.2.7. Cleaning the device incorrectly or exposure to harsh or abrasive cleanser and disinfectant can damage the device. Please follow the cleaning instructions carefully. 2.2.8. Do not use non-recommended cleaning or disinfection solutions with the QT ECG Recorder and its accessories. Please follow the cleaning instructions carefully. 2.2.9. Do not attempt to...