Summary of Contents for Inventec Q21
- Page 1 Model: Q21 Chiline ECG Recorder Instruction Manual MOHW-MD-No. 006588 Please read the instruction manual carefully before using the product.
- Page 2 1. Product Description This product is a single-lead ECG recorder. It can record, display and analyze the ECG signals detected through simple steps. 2. Product Features 1. Integrated design allows the recording and results being displayed on the cellphone screen for bigger and better viewing.
- Page 3 oxygen. Do not use this product on individuals under 18 years old. Keep the conductive part of the product away from charged objects and from the ground. Do not self-diagnose using the results from this product nor thereby alter the treatment plan on your own.
- Page 4 6.2 Start recording 1) Open the Chiline app, then tap “Record an ECG”. 2) The cellphone will search for the ECG recorder. A blue light will remain on when the Bluetooth connection is successful (below image). 3) Choose a recording mode, type of electrodes and duration in the Chiline app to begin recording. 6.3 Recording mode This device supports two types of recording: •...
- Page 5 shown for every 30 seconds of recording (no result available for recording less than 30 seconds). Finger electrodes: Please follow the instructions in the app: 1) Rest both arms comfortably on a table. Orient the device so the power button is facing away from you.
- Page 6 4) When recording is completed, the app will display the results (below image). (Viewing available in both landscape and portrait orientations.) Cable electrodes: Instructions for using the cable electrodes are the same as that for recording in “ambulatory mode”. 6.3.2 Ambulatory mode: Only cable electrodes can be used in ambulatory mode.
- Page 7 Step 1: Plug the cable into the USB port. Step 2: Attach the wires with the electrodes, then place the electrodes at the correct location on the body (below image). White electrode: Place at “RA”, below the right collarbone. Green electrode: Place at “RL”. Red electrode: Place at “LL”.
- Page 8 • Subject • Total time recorded • Number of discomfort marked • ECG results, number of results and percentage of each type of result. 7) If “Recording offline” is tapped or if the Bluetooth connection is off before the recording ends, the device will continue to detect your ECG signals until the end of recording.
- Page 9 (below image illustrates real-time waveforms) 9) When recording is completed, press the power button for three seconds to turn off the device (the device will also turn off automatically after three minutes of inactivity). Note 1: When recording in ambulatory mode, press the power button if you feel pain or discomfort in the chest.
- Page 10 No abnormal waveforms detected (average HR = 51 – 99 bpm) Tachycardia suspected (average HR = 100 – 129 bpm). Relax, stay still and record again with cable electrodes. Please consult a doctor if you have chest pain or discomfort. Tachycardia suspected (average HR ≥...
- Page 11 7. Product Specifications Product Model Product Wireless Bluetooth ECG Recorder (wireless Bluetooth 4.1) Leads Single-lead, Lead I: finger electrodes, Lead II: cable electrodes Product Size 1. Main unit: 66 mm (L) x 40 mm (W) x 12 mm (H) 2. Main unit with storage case: 90 mm (L) x 90 mm (W) x 25 mm Weight 1.
- Page 12 Shelf Life 2 years Note: Please use a charger that meets the requirements. This product uses built-in lithium battery. Users cannot replace the battery on their own. Please recycle batteries 1. Device Notifications and Solutions Indication light The indication light provides three colors for indication: orange, blue and green. Status Indication Light Green light remains on.
- Page 13 connectivity of cable electrodes or finger recording in resting mode. electrodes. Unable to detect ECG signal. Please confirm Disconnection (lead-off) of cable electrodes or heart rate connectivity of cable electrodes. detected is 0 when recording in ambulatory mode. Less than 20% storage space left. A data Less than 20% storage space left in the device.
- Page 14 5) Clean the area of skin that will have contact with the electrode pads. 6) Stop using the product if allergic reactions or inflammation of the skin occurs. 7) Avoid placing the electrode pads on wounded skin. 8) Ensure that the electrode pads are not expired. 9.2 Device care Part Device care...
- Page 15 9.6 Manufacturer’s declarations 9.6.1 Guidance and manufacturer’s declaration—electromagnetic emissions The device is intended for use in the electromagnetic environment specified below. The user must ensure that the device is used in such environment. Emission test Compliance Electromagnetic environment— guidance Radiofrequency emissions CISPR Group 1 The device uses radiofrequency (RF) energy only for its internal function.
- Page 16 For transmitters rated at a maximum not listed, the recommended distance d in meters (m) can be determined using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. Note: •...
- Page 17 9.6.3 Guidance and manufacturer’s declaration—electromagnetic immunity The device is intended for use in the electromagnetic environment specified below. The user must ensure that the device is used in such environment. Electromagnetic Immunity test IEC 60601 Compliance level environment—guidance Test level 8 kV contact 8 kV contact Electrostatic...
- Page 18 for 5 sec for 5 sec Power frequency 3 A/m 3 A/m Power frequency magnetic (50/60 Hertz) fields should be at levels magnetic field characteristic of a typical location in a typical IEC 61000-4-8 commercial or hospital environment. Note: UT is the AC mains voltage prior to application of the test level.
- Page 19 9.6.4 Guidance and manufacturer’s declaration—electromagnetic immunity The device is intended for use in the electromagnetic environment specified below. The user must ensure that the device is used in such environment. Immunity test IEC 60601 test level Compliance Electromagnetic environment—guidance level Portable and mobile RF communications equipment should be used no closer to any part of the device, including cables,...
- Page 20 Note 1: At 80 MHz and 800 MHz, the higher frequency range applies. Notes 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio and AM and FM radio broadcast, cannot be predicted theoretically with accuracy.
- Page 21 Pharmaceutical company address: 1F, No. 37, Wugong 5 Road, Wugu District, New Taipei City, Taiwan, R.O.C. Manufacturer: Manufactured by ACME Portable Corp. for Inventec Appliances Corporation Manufacturer address: 5F, No. 25, Wu-Quan Third Road, Wu-Gu District, New Taipei City, Taiwan, R.O.C.
- Page 22 FEDERAL COMMUNICATIONS COMMISSION INTERFERENCE STATEMENT This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation.
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