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custo guard holter mit den Klebeelektroden custo wing auf transparentem Hintergrund. Das Bild zeigt die richtige Anlage der Elektroden.



Technical specifications

Intended use

custo guard holter is a wearable Holter recording device with an internal powersupply, and is used to record a 3-channel ECG signal in accordance with Holter standards.
custo guard holter includes pacemaker detection. In addition to the ECG signal, the patient’s movement data (walking, running, prone, seated, etc.) is also recorded and later displayed in the custo diagnostic evaluation.

The recording time is 24 up to 120 hours. The recording is saved directly in the custo guard holter recording device.custo guard holter can be used safely on patients with pacemakers.

The system is intended for use by trained specialist staff or physicians in clinics and medical practices. Patients are only allowed to use the recording device after receiving instruction by trained specialist staff.

Patients who are not capable of understanding and following the instructions given are not allowed to use the device. This applies in particular to senile patients or patients
suffering from dementia. The system is not suitable for electrocardiographic monitoring of patients as per DIN EN 60601-2-27, e.g. use in intensive care.

The device is not suitable for intracardiac use.




Number of channels3

Sampling Frequency

(Depending on recording duration)

  • 533 Hz (24 h, high resolution)
  • 400 Hz (24 h, 48 h, 72 h)
  • 100 Hz (5 days, 7 days, unlimited duration)
Resolution

18 bit

3-dB bandwidth ECG amplifier
(depending on sampling frequency)
  • f0 Hz – 105 Hz (with a sampling frequency of 533 Hz)
  • 0 Hz – 80 Hz (with a sampling frequency of 400 Hz)
  • 0 Hz – 20 Hz (with a sampling frequency of 100 Hz)
Minimum detection threshold
(depending on sampling frequency
  • 10.46 μV (with a sampling frequency of 533 Hz)
  • 5.51 μV (with a sampling frequency of 400 Hz)
  • 5.51 μV (with a sampling frequency of 100 Hz)
ECG measurement range+/- 685.7 mV.
Radio frequency bandISM 2.4 GHz
Radio transmission power
  • 10 mW
Radio communicationFHSS Frequency Hopping Spread Spectrum
Running Time
  • internal rechargeable Battery approx. 10h
  • AAA-Batteries approx. 5h
Radio modulationGFSK

Radio transmission rate

1Mbit/s

Connection to PC

via custo guard base charging and communication unit
(USB) and Bluetooth

Power supply

Lithium polymer battery

Battery runtime)1

up to 168 h/7 days

Battery charging time

approx. 2 hours, charging current max. 130 mA

Status display

LED indicators for ECG quality and charging status

Dimensions

approx. 70 * 42 * 12 mm (L * W * H)

Weight

approx. 30 g

Ingress protection level

IP 65

Operating life

approx. 5 years (after this time has elapsed, the recording
duration of up to 168 h can no longer be guaranteed)

Operating conditions

  • Temperature: +5°C ... +45°C
  • Humidity: 10 ... 95 % rH
  • Air pressure: 700 ... 1060 hPa

Transport and storage conditions)2

Temperature: -20°C ... +45°C
Humidity: 10 ... 95 % rH
Air pressure: 700 ... 1060 hPa
Only for storage in a medical environment, under
consideration of the conditions mentioned here.

Classification

Device with internal power supply, Class IIa, Type BF

Applied standards

DIN EN ISO 13485, DIN EN ISO 14971, DIN EN ISO 20417, DIN EN ISO 15223-1, DIN EN 60601-1, DIN EN 60601-1-2, DIN-IEC 60601-1-6, DIN EN 62304, DIN EN 62366-1, DIN EN ISO 10993-1, DIN EN 60601-2-47, DIN EN 60601-1-11, DIN EN ISO 10993-5, DIN EN ISO 10993-10


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