3 Important safety information
ASTOPAD
®
Instructions for Use
13
CAUTION
Misinterpretation!
Shadows of the internal cables and sensors may be captured in diagnostic images
(CT, X-ray) taken when the patient is using the ASTOPAD applied parts. The im-
ages should be assessed by clinical experts to determine the quality and diagnostic
suitability of the image.
CAUTION
Risk of radio interference!
Due to the presence of electromagnetic interference, essential performance char-
acteristics may be unusable or only usable to a limited extent. This results in a
risk of hypothermia for the patient.
According to Standard IECEN 60601-1-2, medical electrical equipment requires
special precautionary measures in regard to electromagnetic compatibility (EMC).
The ASTOPAD may cause radio interference or may interfere with the operation of
equipment in close proximity. It may be necessary to take appropriate corrective
action, such as a realignment, a new configuration of the ASTOPAD or shielding.
3.4 Notices
NOTICE
The specified moisture resistance IPX2 for the ASTOPAD applied parts is en-
sured only when the connector
- is connected to a suitable extension cable, or
- the attached protective cap is used.
Actions to avoid damaging the ASTOPAD:
- Do not immerse the ASTOPAD control unit, the applied parts or the plugs of the
connection cables in liquid.
- Do not disinfect the ASTOPAD control unit and/or the applied parts with:
Steam (e.g. in autoclaves)
Hot air
Thermochemical cleaning solutions
- The ASTOPAD applied parts must not be disinfected with bleach solution
(hypochlorite or other agents containing chlorine).
- Do not use any cleaning or decontamination methods other than those recom-
mended by the manufacturer.
The customer is responsible for the proper packaging and labelling of returns.
The specified defibrillation protection is ensured only when the ASTOPAD applied
part is connected to the extension connection cable and the ASTOPAD control
unit.
