The WECARDIO ECG Event Recorder is a portable device designed for real-time ECG signal acquisition, storage, and wireless transmission for patients with arrhythmia. It is intended for non-clinical use as a reference for medical diagnosis and is not a replacement for diagnostic clinicians.
Function Description:
The ECG Event Recorder captures single-lead ECG signals over a 30-second duration. It connects wirelessly via Bluetooth 4.0 to a smartphone or iPad (with Bluetooth and Wi-Fi/Data enabled) running the AIRCardio APP. The device supports various checks including Arrhythmia Check, ST Check, and HRV/ANS Check. The metal sheets on the side and front of the device serve as the application parts for ECG signal collection.
Important Technical Specifications:
- Models: WeCardio UN; WeCardio WF
- Dimensions:
- WeCardio UN: 87mm × 49mm × 7mm
- WeCardio WF: 90mm × 50mm × 10mm
- Weight (with battery):
- WeCardio UN: 33g
- WeCardio WF: 38g
- Carton Material: PC plastic
- Battery: Lithium-ion battery/d.c.3.7V
- Working Hours: Approximately 8 hours (480 recordings)
- Bandwidth: 0.5Hz – 40Hz
- Input Impedance: ≥ 3.0 Mohm
- Input Range: 0.05 ~ 6 mV
- Sample Rate: 200 Hz
- Sampling Precision: 12 bits
- Transmission Mode: Bluetooth 4.0
- Recording Duration: 30 seconds, single-lead ECG
- Operating Conditions:
- Temperature: +5°C to +40°C
- Humidity: 25% to 93% RH (without condensation)
- Pressure Altitude: 700 hPa to 1060 hPa
- Storage and Shipping Conditions:
- Temperature: -25°C to 55°C
- Humidity: 15% to 93% RH (without condensation)
- Pressure Altitude: 700 hPa to 1060 hPa
- Classification: Class II / Internally powered equipment; Type BF applied part; IP22; Continuous operation mode.
- Regulatory Compliance: Conforms to IEC60601-1, IEC60601-1-2-2014 Class IIa, IEC60601-1-11, IEC 60601-2-25, FCC Rules Part 15, EMC & R&TTE. Quality System conforms to ISO13485.
Usage Features:
The device requires a smartphone or iPad with Bluetooth 4.0 (Android 4.3+ or iOS) and the AIRCardio APP.
- APP Download: Available on Google Play (Android) or App Store (iOS) by searching "WECARDIO," or via a provided QR code/download link.
- User Login: Users can register with email, sign in with existing credentials, or use a "Try Out" option for testing (without result feedback). Multiple user accounts can be managed, beneficial for family members.
- Bluetooth Pairing: To pair, users touch the two metal pads on the device, wait for a red light, and enter the pairing code "000000" when prompted by the app.
- Arrhythmia Check: Users gently grip the metal sheets with forefinger and middle finger of both hands, resting hands on a desktop or thigh, maintaining a relaxed state. The app displays a progress bar, and users should remain still and silent during the 30-second recording. After recording, symptoms can be selected, and waveforms are displayed. Results are updated in the recording list.
- ST Check: Similar to Arrhythmia Check, users grip the metal sheets. For specific lead positions (I, II, V1, V2, V4, V6), the side electrode is placed on the corresponding chest position. If the light doesn't show red, slightly wetting the skin is recommended. The check is performed 5 times.
- HRV/ANS Check: This check takes 5 minutes. Users maintain a comfortable, relaxed pose while gripping the metal sheets. This feature evaluates heart self-regulation capability and is recommended every two weeks for users with high stress or poor sleep.
- Recording List:
- Local Recordings: Data stored on the mobile phone. These are removed when clearing phone cache but can be re-downloaded if uploaded to the cloud.
- Cloud Recordings: Data successfully uploaded to the server. These can be re-downloaded even after clearing phone cache.
- Result Icons: Green indicates stable heart rate; Red indicates arrhythmia (requires double-check); Yellow indicates artifact (requires re-check). Users are advised to seek hospital consultation if results consistently show red, even with proper usage.
- Detailed View: Clicking a recording provides details, including waveform viewing (with cursor movement and zooming) and PDF report download/email options.
- Settings: Users can adjust checking time (10 or 30 seconds), select devices, and change account passwords.
Maintenance Features:
- Battery: Uses rechargeable Lithium batteries. Risk of explosion if replaced with an incorrect type. Dispose of used batteries according to instructions. Battery replacement should be done by BORSAM. Charging is done via a certified USB cable (DC 5V, 115mA). The device will not work properly during charging. Recharge when mobile telecom equipment indicates low power.
- General Care:
- Do not open or attempt to repair the device; only authorized service personnel should perform repairs.
- Avoid dropping or subjecting the device to severe impacts.
- Do not use extreme force when pressing the display or keys.
- Clean only with a soft, dry, lint-free cloth. Do not use solvents, abrasives (wire-wool, metal polish), or allow liquids to enter the device.
- Avoid temperatures exceeding 45°C (113°F) during cleaning.
- Environment:
- Keep away from extreme heat (e.g., car dashboard, heater).
- Avoid extremely damp or dusty places.
- The product is not waterproof; do not use or store it where fluids (rain, spray, juice, coffee, steam, perspiration) can splash onto it.
- Preventive Maintenance: Monthly cleaning of the device exterior with a lint-free dry cloth is recommended.
- User Responsibility: Patients are the operators and are responsible for cleaning the device with a soft cloth and setting their information. Repairing the device or replacing the battery must be done by the manufacturer.
- Interference: Magnetic and electrical fields can interfere with performance. Ensure nearby external devices comply with EMC requirements. Wireless communication equipment (phones, cordless phones, walkie-talkies, MRI devices) can be sources of interference.
- Safety: Not suitable for use in the presence of flammable anesthetic mixtures. Not a diagnostic device and should not be used with pacemakers or implanted defibrillators. Not defibrillation-proof.
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