The energy configuration of the next energy level must be greater than or equal to the energy of the previous energy level.
It meets the ERC Guidelines 2021 and AHA Guidelines 2020 by default.

Provide energy accuracy

The tolerance in the data is ±15%.

Waveform parameters (200J)

Waveform parameters (170J)

Waveform parameters (150J)

Waveform parameters (50J)

Charging duration

Preservation parameters of the heart for the first charge impact:

1. New Battery 3C
   From opening to charging at 150/200 J: completed in no more than 17/22 seconds.
   From AED analysis to charging to 150/200 J completed: no more than 8/12 seconds
2. New battery 3G
   From switching on to charging (150/200 J): completion time no more than 13/16 seconds. From AED analysis to charging (150/200 J): completion time no more than 5/8 seconds.
3. After 3C testing, the battery discharges 15 times its maximum energy from switching on to charging at 150/200 J in no more than 17/22 seconds.
   From AED analysis to charging to 150/200 J completed: no more than 8/12 seconds
4. After the battery reaches 3G, the maximum energy discharge of 15 times is completed from power-on to charging at 150/200 J in no more than 13/16 seconds. Analysis by the AED shows that the charging process from 150/200 J to charging is completed in no more than 5/8 seconds.

electrode

Battery

Backup life

Battery 3C: Up to 48 months + 12 months warranty conditions: The device is powered by a new battery with an ambient temperature of 20°C ± 5°C, performs a weekly self-test, and is not powered on or connected to the network.

Battery 3G: Maximum service life of 12 years. Conditions: The device is powered by a new battery with an ambient temperature of 20°C±5°C, performs a weekly self-test, is not powered on, has no network connection, and has no more than 500 charging cycles.

runtime

Battery 3C: Operate for 9 hours with a new battery at an ambient temperature of 20°C±5°C, without defibrillation charging or discharging, with volume set to low and display brightness set to indoor.

Battery 3G: Operate for 14 hours with a new battery at an ambient temperature of 20°C±5°C, without defibrillation charging or discharging, with volume set to low and display brightness set to indoor.

Discharge performance

Battery 3C: 130 times 200 J discharge, ambient temperature 20℃±5°, voice volume set to low, display brightness set to indoor.

Battery 3G: 230 times 200 J discharge, ambient temperature 20℃±5°C, voice volume set to low, display brightness set to indoor.

After the shelf life under safe storage conditions, the battery for 3C devices is expected to withstand approximately 6 times the impact. The battery for 3G devices, when fully charged, is expected to withstand more than 6 times the impact.

When the remaining battery power is low, the device will display a "Low Battery Power" message when turned on. The device can be left in standby mode for more than one month.

The device can perform at least 10 discharges of 150J or 6 discharges of 200J, followed by 40 minutes of operation. (The device is powered by a battery at 20°C ± 5°C). If recharging is no longer possible, the device will automatically switch to CPR mode.

CPR Feedback Guidelines

Compression frequency range: 100-120 cpm.
Compression accuracy frequency: ±3cpm.
Compression depth range: 50-60 mm.
Compression depth accuracy: ±5 mm or ±10%, whichever is greater.

USB Specification

USB ports: 1 USB
Electrode socket: Serial communication port

Wireless LAN specifications (if any)

WLAN standard: IEEE 802.11 b/g/n
Frequency: 2.4 GHz Maximum radiated output power: 20.5 dBm EIRP (RF power, including maximum antenna gain (3.37 dBi))
Wireless transmission rate: up to 150 Mbps

LTE specifications (if any)

aisle:
LTE-FDD: B1/B3/B7/B8/B20/B28A
LTE-TDD: B38/B40/B41
Transmission power:
LTE-FDD: 23±2 dBm
LTE-TDD: 23±2 dBm
Standard: 3GPP E-UTRA Version 11

monitor

Data storage

MYPRIMEDIC Configuration Application

Safety category label

Devices with internal power supply, defibrillator type high-intensity ignition

The product bears the CE mark, indicating that it complies with the provisions of the Medical Devices Regulation (EU) 2017/745 concerning medical devices and meets the essential requirements of Annex I to this Directive.

Environmental Standards

Operating conditions

Temperature: -5°C to 55°C
Humidity: 0 to 95%, but no condensation; Pressure: 540 hPa to 1062 hPa

(If the device was previously stored in a suitable environment, it can operate at -20°C for at least 20 minutes.)

Short-term transport and storage conditions (<1 week)

Temperature: -30°C to 70°C
Humidity: 0 to 95%, but no condensation; Pressure: 510 hPa to 1062 hPa

Long-term transportation and storage conditions (>1 week)

Temperature: -5°C to 55°C
Humidity: 0 to 95%, but no condensation; Pressure: 510 hPa to 1062 hPa

size

670, 671, 670A, 671A: 151 mm x 151 mm x 73 mm (±2 mm)
675, 678, 675A, 678A: 151 mm x 151 mm x 76 mm (±2 mm)

weight

670, 671, 670A, 671A: Approximately 1.0 kg (±0.2 kg)
675, 678, 675A, 678A: Approximately 1.1 kg (±0.2 kg)

Minimum lifespan of the combined device, electrodes, and battery

For at least 4 years, the temperature is between 15°C and 35°C, the humidity is 80%, and the air pressure is between 540 hPa and 1060 hPa.

Test Standards

Drop test: Test height 1.6m
Impact testing: Compliant with IEC 60601-1-12:2014+AMD1:2020 and IEC 60601-1-11:2015+AMD1:2020 CSV
Vibration test: Compliant with IEC 60601-1-12:2014+AMD1:2020 and IEC 60601-1-11:2015+AMD1:2020 CSV

Software Information

AED Embedded Software (Version: 01.00.00.00)

Appendix B: Warranty

During the 8-year warranty period, the manufacturer will remedy any defects in the equipment free of charge if the defects are due to material or manufacturing errors. The equipment can be restored to its original functionality as selected by the manufacturer through repair or replacement.

Claims under the warranty will not extend the original warranty period.

All other claims against the manufacturer are excluded unless such claims are based on intent or gross negligence or mandatory legal liability standards.

If you have a warranty claim, please return the device to your dealer or manufacturer with proof of purchase (such as an invoice) showing your name and address.

Metrax is happy to provide after-sales service, even after the warranty period has expired.

Appendix C: Rhythm Detection System

The rhythm detection system on the heart preserver can analyze the patient's electrocardiogram and detect rhythms that are either shock-prone or not.

The algorithm

• Filtering interference and detecting artifacts
• Calculate multiple electrocardiogram signal parameters, including frequency and morphological parameters.
• Reject implantable pacemakers and artificial products

Rhythm Category

■ A shockingly fast pace:
Ventricular fibrillation (VF): Amplitude 0.2mV
pulseless ventricular tachycardia (pVT)

■ Non-shock rhythm:
Normal sinus rhythm, supraventricular tachycardia, atrial fibrillation/flutter, sinus bradycardia, unique ventricular rhythm, polyvinyl chloride (extraventricular systole) characteristic sinus rhythm, cardiac arrest.

Rhythm database source:

The ECG evaluation data in the algorithm evaluation database comes from international standard databases. ECG data from each database can be downloaded from https://www.physionet.org. To collect ECG data for different rhythms, we selected the following databases, described below:

• VFDB: MIT-BHI Database of Malignant Ventricular Ectopicities
• CUDB: CU Database of Ventricular Tachyarrhythmias
• MITDB: MIT-BHI Arrhythmia Database
• European ST-T Database
• SVDB: MIT-BHI Supraventricular Arrhythmia Database
• MIT-BHI Atrial Fibrillation Database
• LTAFDB: Long-Term A/F Database
• SDDB: Dynamic Electrocardiogram Database for Sudden Cardiac Death
• Shaoxing: A 12-lead electrocardiogram database for arrhythmia research
• AHADB: American Heart Association Database
• NSTDB: MIT-BHI Noise Stress Test Database
• MDB: Metax GmbH Database

Test results of the device's performance configured with a heartbeat preservation and impact rhythm analysis algorithm. Complies with IEC 60601-2-4 requirements.

The test results for the requirements of IEC 60601-2-4 are shown below.