Cardioline ECG100+ - Device Classification and Environmental Conditions

ECG100+ - ECG200+ - ECG100S - ECG200S
2. SAFETY INFORMATION
 If the electrodes are not properly connected to the patient, or one or more patient leads are
damaged, the display will indicate a lead failure. When the ECG is printed, these leads will come out
on paper as a square wave.
 As defined by the IEC 60601-1 and IEC 60601-2-25 safety standards, the device is classified as
follows:
 IP class equipment (internal power ME) - class I on external AC/DC power supply
 Defibrillation-proof Type CF applied parts.
 Ordinary equipment.
 Not suitable for use in the presence of flammable anaesthetics.
 Continuous operation
NOTE: From a safety view point, the external power supply is declared “Class I” based on IEC 60601-1
standard. A three-pole plug is used to guarantee earthing together with the power lines. The earth
terminal of the power cable is the only point where the unit is earthed. Exposed metal parts which are
accessible during standard operation have a double insulation from the power lines. The internal
earth connections are a functional earthing.
 Accuracy of measurements taken with the device is compliant with IEC 60601-2-25.
 Power Supply has the following characteristics:
 Model: AFM60US18
 Manufacturer: XP Power Limited
 Rated Input: 100-240 VAC, 50-60 Hz, 1.5-0.9 A
 Rated Output: 60 W, 18 V, 3.34 A
 Protection Class: I
 Degree of Protection: IP20
 The device is a Class IIa in compliance with Directive 93/42/EEC.
 The device is a prescription device according to FDA regulation
 In order to prevent damage to the device during transportation and storage (when still in its original
packaging), comply with the following environmental conditions:
Ambient temperature .....................
5°C to 40°C
Relative humidity ............................
20% to 90%
Atmospheric pressure .....................
700 mBar to 1060 mBar
 The device is intended for use in hospitals or doctor's offices and should comply with the following
environmental requirements:
Ambient temperature .....................
+10°C to 40°C
Relative humidity ............................
50% to 90%