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Performance - Technical Data
   
DEFIBRILLATION  
Operating modes HeartSave myPAD Semi-automated external defibrillator
  HeartSave myPAD Fully-automated external defibrillator
   
Waveform type Biphasic truncated exponential, auto-compensation according to patient impedance
   
Optional output energy For adults: 150 J, 170 J, 200 J
  For children: 50 J
   
Default shock series Default adult energy sequence:
  Level 1: 150 J
  Level 2: 170 J
  Level 3: 200 J
  Default children energy sequence:
  Level 1: 50 J
  Level 2: 50 J
  Level 3: 50 J
  The energy configuration of the latter level must be greater than or equal to the energy of the previous level.
  Meeting ERC guidelines 2021 and AHA guidelines 2020 by default
   
Charge duration Parameter of HeartSave for charging to first shock:
  1) new battery 3C
  From switch on to charge 150/200 J done: no more than 17/22 s
  From AED analysis to charge 150/200 J done: no more than 8/12 s
  2) new battery 3G
  From switch on to charge 150/200 J done: no more than 13/16 s
  From AED analysis to charge 150/200 J done: no more than 5/8 s
  3) battery 3C after 15 times of max energy discharges
  From switch on to charge 150/200 J done: no more than 17/22 s
  From AED analysis to charge 150/200 J done: no more than 8/12 s
  4) battery 3G after 15 times of max energy discharges
  From switch on to charge 150/200 J done: no more than 13/16 s
  From AED analysis to charge 150/200 J done: no more than 5/8 s
   
Applicable impedance range 25 - 200Ω
   
ELECTRODES  
Manufacture Baisheng Medical Co., Ltd.
Trade name and model SavePads PLUS C
  OBS-DE/P 303A1206 (Adult and child without CPR feedback sensor)
  SavePads PLUS CS
  OBS-DE/P 303A1207 (Adult and child with CPR feedback sensor)
Shelf life with sealed pouch 60 months (Shelf-life duration verified under environment condition of 25°C, higher ambient temperature may reduce shelf life)
Total area 117 ± 10 cm²
Effective area 86 ± 10 cm²
Cabel length 1.40 ± 0.2 m
Maximum number of defibrillation shocks 50 shocks
Positioning of electrodes Electrode placement depends on the patient's age. Refer to Section 7.5.2 for details
CPR feedback sensor 1 cable connected (for electrodes with CPR feedback sensor only)
   
SSCP EUDAMED link preparation ongoing.
(Summary of safety and clinical performance)  
   
BATTERY  
Model Battery 3C (NRL03C)
  Battery 3G (NRL03G)
Battery type LiMnO2, 12V, 2.8Ah, non-rechargeable (NRL03C)
  Li-ion, 14.4V, 2.95Ah, rechargeable (NRL03G)
Standby life Battery 3C: 5 years
  Condition: The device is powered by a new battery at 20 °C± 5 °C of ambient temperature, weekly self-test, no switch on of device, no network connection.
  Battery 3G: 12 years
  Condition: The device is powered by a new battery at 20 °C± 5 °C of ambient temperature, weekly self-test, no switch on of device, no network connection, under charging cycle of no more than 500 times.
Operating time Battery 3C
  Operate 9 hours by a new battery at 20°C ± 5°C of ambient temperature, not performing defibrillation charges or discharges, voice volume set to low, display brightness set to indoor.
  Battery 3G
  Operate 14 hours by a new battery at 20°C ± 5°C of ambient temperature, not performing defibrillation charges or discharges, voice volume set to low, display brightness set to indoor.
Discharge times Battery 3C
  130 times 200 J discharge by a new battery at 20°C ± 5°C of ambient temperature, voice volume set to low, display brightness set to indoor.
  Battery 3G
  230 times 200 J discharge by a new battery at 20°C ± 5°C of ambient temperature, voice volume set to low, display brightness set to indoor.
Discharge times after shelf-life time After shelf-life time of standby under storage condition, Battery 3C is expected to support approximately 6 times of shocks.
  Battery 3G is expected to support more than 6 times of shocks if fully charged.
Remaining charge after 'Battery low' is prompted When the remaining battery capacity is low, the device will announce 'Battery low' when device switched on.
  Device can keep standby mode for more than 1 month.
  The device can perform at least 10 times 150J or 6 times 200 J discharge, then operate 40 minutes. (The device is powered by a battery at 20 °C± 5 °C of ambient temperature). If charging is no longer possible, the device automatically switches to cardiopulmonary resuscitation mode.
   
CPR FEEDBACK SPECIFICATION Range of compression frequency: 100-120cpm. Accuracy of compression frequency: ±3cpm.
  Range of compression depth:50-60mm. Accuracy of compression depth: ±5 mm or ±10%, whichever is larger.
   
USB SPECIFICATION  
USB port 1 x USB
  Electrodes socket: serial communication port
   
WLAN SPECIFICATION (if available)
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 Max. 150 Mbps
   
LTE SPECIFICATION (if available)
Channel 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 Release 11
   
COLOUR DISPLAY (if available)
Type Colour LCD display (only for 675, 675A)
  Touch LCD display (only for 678, 678A)
Working mode Auto, in-door, outdoor
  (Self-adjust display brightness based on environment brightness)
Size 4.3 inch (10,9 cm)
Resolution 800 x 480
ECG waveform animation 1-Channel
   
DATA STORAGE  
Internal storage 8G
ECG wave 160 hours
Event 10 000 events
Audio log 32 hours
CPR data 160 hours
Self-test report 36 500 reports
Log data 100 000 events
   
MYPRIMEDIC CONFIG APP
Minimum requirement of device iOS Android
CPU 2.5 GHz 2.0 GHz
RAM 3 GB 6 +1 GB
Storage 64 GB 64 GB
Display 1792 x 828 2408 x 1080
Bluetooth 5.0 5.1
OS iOS14 Android 11
SAFETY  
Classification Device with internal power supply, Defibrillation-proof type BF
Identification The product bears CE mark indicating its conformity with the provisions of the Medical Device Regulation (EU) 2017/745 concerning medical devices and fulfil the essential requirements of Annex I of this directive.
Classification IP66
   
ENVIRONMENT SPECIFICATION  
Constant operating conditions -5 °C to 55 °C,
  0 to 95 % rel. humidity, but without condensation
  540 hPa to 1062 hPa
  (The device supports operate at least 20 minutes under -20 °C if device is stored in terms of storage condition before)
Conditions for storage or transport between uses -30 °C to 70 °C,
  0 to 95 % rel. humidity, but without condensation
  510 hPa to 1062 hPa
Conditions for transport with original package -30 °C to 70 °C,
  0 to 95 % rel. humidity, but without condensation
  510 hPa to 1062 hPa
Dimensions 670, 671, 670A, 671A:
(L x W x H) 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:
  approx. 1.0 kg (±0.2 kg)
  675, 678, 675A, 678A:
  approx. 1.1 kg (±0.2 kg)
Minimum lifetime with combined device, electrodes and battery At least 5 years with storage condition of temperature 15°C-35°C, humidity ≤ 80%, air pressure 540hPa to 1060hPa.
Drop test Test with height 1.6m.
Shock test Complies with requirements of 10.1.3a), IEC 60601-1-12:2014+ AMD1:2020 and 10.1.3, IEC 60601-1-11:2015+AMD1:2020 CSV
Vibration test Complies with requirements of 10.1.3b), IEC 60601-1-12:2014+ AMD1:2020 and 10.1.3, IEC 60601-1-11:2015+AMD1:2020 CSV
   
SOFTWARE INFORMATION OF THE DEVICE AED embedded software (version: 01.00.00.00)

 

 

SAFETY - DANGER, WARNING, CAUTION
 
Medical indication
Devices are intended for treatment of victims of cardiac arrest. Victims of cardiac arrest exhibit the following symptoms:
  • Unconsciousness
  • Absence of normal breathing
 
Medical contraindications
Devices should not be used if the patient shows signs of life. Signs of life are:
  • Consciousness
  • Breathing
Devices should not be used on patients younger than one year.
 
Dangers:
The device should not be used in the vicinity of flammable materials (e.g. cleaning solvents or similar) or in an atmosphere enriched with oxygen or flammable gases/vapours. Always check the environment condition during usage of the device.
To use the device on a patient, you must:
  • Check the device before use to guarantee it is in good condition.
  • Use new, undamaged, and unexpired electrodes for every patient to avoid any possible burns to the skin.
  • Only connect SavePads electrodes to the device.
  • Do not use the device close or near to other sensitive equipment (e.g. some measuring equipment are always sensitive to magnetic fields) or strong sources of interference. Keep a sufficient distance away from other energy sources (e.g. microwave oven, induction stove, etc.). These equipments may cause the device not working properly or doesn’t work. Please make sure to disconnect all other devices from the patient before defibrillation.
  • Prior to defibrillation, disconnect all other electrically operated medical devices which are not defibrillation-proof from the patient.
  • Keep defibrillation electrodes away from other electrodes, metal objects and earthed objects.
  • Do not use the device on infants under 1-year old.
  • Place electrodes precisely according to graphic guidance.
  • Dry patient chest with provided towel and use razor to remove hair if available before applying the electrodes.
  • Do not place the electrodes over any implanted pacemaker to avoid unexpected damage from defibrillation energy.
  • Do not touch the patient during ECG analysis.
  • Stop CPR during ECG analysis.
  • Keep away from other medical devices, a danger to the patient may apply.
Warn surrounding people loudly and clearly before defibrillation to make sure they have no contact with the patient.
 
Warnings:
Keep the device away from children.
 
Only use the device on a patient if:
  • You have ensured its operational safety before using it and that it is in good condition.
  • the state of the patient requires or allows an application of defibrillator.
Before using the device, ensure the environment temperature is in the range of operating temperature specification.
Do not apply the device if it is defect or visible damaged (e.g. damage of cables or housing of the device)
 
Be aware of the electrodes cable:
Strangulation may occur by electrodes cables to the patient.
 
Be aware of shock energy:
AED defibrillation works by depolarizing the cardiac muscle with electric current. To achieve the intended purpose, AEDs need to release a large amount of electrical energy (less than 200J). This electrical energy can potentially lead to myocardial damage.
Repair and installation of the device should be carried out by professional authorized persons only.
  • Use original accessories from the manufacturer only.
  • Clean the device as guided in this instruction of use.