Use Instructions

General Information
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WARNING!
Lowest gas flow and pressure
Depending on age and health condition of the patient, the smallest possible gas
flow and pressure for establishing the cavity should be selected. It is not recom-
mended to exceed insufflation pressures of 15mmHg in transanal minimally invas-
ive surgery procedures.
3.4 General Precautions
CAUTION!
Continuous operation
After 24 hours of continuous operation, a device self-test must be carried out.
Switch device off and on again.
CAUTION!
Endoscope
The device may only be connected with endoscopes designed for and featuring the
technical specification permitting such a combined use. Any utilized endoscopes
must comply with the most recent versions of EC60601-2-18 and ISO8600. Com-
bining/connecting with other devices generates a medical electrical system (MES).
The system configurator is responsible for compliance with the standard
IEC60601-1 / EN60601-1 in its latest version.
CAUTION!
Electrical interference
(See ChapterElectromagnetic compatibility [}62]). Care was taken during the de-
velopment and testing of this device that electrical interference of or from other
devices or instruments was practically eliminated. However, if you still detect or
suspect such interference, please follow these suggestions:
• Move this, the other, or both devices to a different location
• Increase distance between used devices
• Consult an electro-medical expert
CAUTION!
Use of other accessories, other transducers and cables
The use of accessories, transducers, and cables other than those specified, with the
exception of transducers and cables sold by the MANUFACTURER of the ME EQUIP-
MENT or ME SYSTEM (see ChapterGlossary) as replacement parts for internal com-
ponents, may result in increased EMISSIONS or decreased IMMUNITY of the ME
EQUIPMENT or ME SYSTEM.
CAUTION!
ME Device in Rack
The ME device may not be used when stacked or stored directly adjacent to or with
other devices. If it should be necessary to operate the device close to stacked with
other devices, the ME device or ME system should be monitored to ensure it works
properly as configured.
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DRAFT