2. CONTRAINDICATIONS, WARNINGS, PRECAUTIONS AND ADVERSE REACTIONS
Read this User Training Manual carefully, it is a component of the device and must be available at all times. Only use the
device for the described purpose (see Section 1.1). Please also observe the User Training Manual of the PC software
used with the measuring unit PN 07402.
2.1 General
The ECG measuring unit may only be used by persons who can guarantee that it will be used properly based on
their training/education or knowledge e.g. instruction.
If original accessories are not used, this could result in function failures and bio-compatibility cannot be assured.
Observe that in such cases, any warranty or liability claims are void when neither the accessories recommended
in the User Training Manual nor the original replacement parts are used.
The ECG measuring unit is not suitable for use in rescue helicopters or ambulances.
Observe section 5 “CLEANING AND DISINFECTION” to avoid contamination.
Only allow repair work be done by the manufacturer or other expert personnel.
Before each use, visually inspect the device, the electrode cables and the adhesive electrodes. If there is any
externally visible damage or if the self-test fails the device may no longer be used.
The ambient conditions specified in the technical data are to be complied with.
The ECG measuring unit may not be submerged in liquids or have liquids poured on it, be intentionally sprayed
or be exposed to rain.
The ECG measuring unit may only be opened by authorized expert personnel. If the device is opened without
permission, the warranty is void.
The manufacturer is not liable for the function of the ECG measuring unit if the device is improperly maintained
by the owner/operator or if it is treated in a way which doesn’t correspond with its proper use in accordance with
this user manual.
The signals output by the measuring unit do not meet the alarm standard for medical electrical devices, DIN EN
60601-1-8.
To guarantee patient safety, the receiver unit and peripheral devices are to be operated outside of the patient’s
immediate surroundings, i.e. with a minimum distance of 1.5 m to the patient.
All parts of the measuring unit, including accessories, which come into contact with the patient during intended
use, meet the requirements of the applicable standards with regard to bio-compatibility.
2.2 Operating the device
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