Environmental Conditions; Declaration Of Conformity; Intended Use, Intended User, Contra-Indications And Precautions, Residual Risks - D-Heart 4021 Manual De Instrucciones

3. ENVIRONMENTAL CONDITIONS

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Operating Temp (battery discharging): -10°C to 40°C
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Operating Temp (battery charging): +5°C to +35°C
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Storage Temp: -20°C to +30°C
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Storage Humidity: 45% ~ 75% (relative)
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Atmospheric pressure range: 700 hPa to 1060 hPa

4. DECLARATION OF CONFORMITY

The D-Heart Portable ECG Device is compliant with the following standards:
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ETSI EN 301 489-1 V2.1.1 (2017-02)
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ETSI EN 301 489-17 V2.2.1 (2012-09)
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CEI EN 60601-1-2:2016-04
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CEI EN 60601-2-25:2016-04 (*)
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ETSI EN 300 328: v2.1.1 (2016-11)
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CEI EN 60601-1-11:2015
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IEC 60601-1:2005+A1:2012
5. INTENDED USE, INTENDED USER, CONTRA-INDICATIONS AND
PRECAUTIONS, RESIDUAL RISKS
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The device is intended for supporting or providing useful information regarding the process of
diagnosis or care of users at risk for or with heart diseases.
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The device is intended to be operated in hospital, general physician's office, out-of-hospital
locations such as homecare environment.
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The device is intended for adults. Keep the device away from young children up high, out of sight,
and out of reach to prevent potential ingestion hazards of small parts (e.g. disposable electrodes).
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The conductive parts of electrodes should not contact any other conductive parts including earth.
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Use ONLY disposable electrodes provided with the device or other electrodes of the same model.
Contact [email protected] to be informed on how purchasing the disposable electrodes.
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The device shall not be operated in combination with a cardiac defibrillator.
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The device shall not be operated in combination with high frequency surgical equipment.
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The device shall not be operated in combination with flammables.
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The device shall not be operated in combination with flammable anaesthetics.
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The device shall not be operated in environments saturated by oxygen.
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The device is classified as Class B according to CISPR 11:2009 (Radio-frequency disturbance
characteristics).
(*) The conformity is limited to the applicable tests (as reported in the relevant Test Reports).
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User Manual Smartphone ECG Device
D-Heart