Zimmer Sonido Smart, Инструкция по эксплуатации, Страница: 23 / 173

8
Non-approved devices
CAUTION:
DO NOT use ANY non-approved devices.
If devices are connected without the approval of ZIMMER MEDIZINSYSTEME, the warranty will become
VOID.
The system cannot be used with RF surgical equipment, otherwise there is a risk of causing burns to the
patient.
Any device connected to this system must conform to one or more of the requirements listed
below:
-
EN 60601-1 or EN 60950
-
The devices must be connected to a protective conductor.
CAUTION:
Unsafe operation or malfunction may result. Use only accessories, options and replacement parts ap-
proved or recommended in this operating manual.
Peripheral devices that can be used in the patient environment
The system has been tested for general safety, compatibility and compliance with the following integrated image-capturing
devices:
B/W video printer: Mitsubishi P93W, SONY UP-711MD, Sony UP-D898MD
Colour video printer: Mitsubishi CP31W
The system may also be used safely while connected to devices other than those recommended above if the devices
and their specifications, installation and connection data, installation and interconnection with the system conform to
the requirements of EN60601-1.
An adapter is considered part of the medical electrical device
Connecting equipment other than that specified in the operating manual may result in a risk of electric shock. Re-
placement or alternative devices and connections need to be checked for compatibility and compliance with stand-
ard EN 60601-1 by the system manufacturer. The operator assumes sole liability for device modifications and
possible malfunctions arising therefrom.
General precautions for installing an alternative peripheral device or a network include:
The additional device(s) must have meet the appropriate safety standards and possess a CE mark.
It must be ensured that the device has appropriate mechanical mounting, and that the combination is stable.
The risk and leakage current of the combination must comply with standard EN 60601-1.
The combination's electromagnetic emissions and interference immunity must conform to EN 60601-1-2.
Peripheral devices that cannot be used in the patient environment
The system has been verified for compatibility and compliance for connection to a local area network (LAN) and is con-
nected via a LAN cable, provided the components are EN 60601-1 compliant.