User Manual

General Information
11
en
DANGER!
Additional equipment
Additional equipment connected to medical electrical devices must be demon-
strated to be compliant with their respective IEC or ISO standards (IEC 60601-1,
IEC 60950 or IEC 62368 for data processing equipment). Furthermore, all config-
urations must comply with the normative requirements for medical systems (see
section 16 of the last valid edition of IEC 60601-1). Anyone who connects addi-
tional devices to medical electrical equipment is a system configurator and as
such is responsible for the system's compliance with the normative require-
ments for systems. Please contact the technical service if you have additional
questions.
DANGER!
Hypothermia (monitoring body temperature)
The continuous flow of the distension liquid may lower the body temperature of
the patient. Lower body temperatures can cause coronary and cardiovascular
problems. Always monitor the patient's body temperature during the entire sur-
gical procedure. Make especially sure that the following, hypothermia promot-
ing, operation conditions are avoided as best as possible:
• longer operating times
• use of cold irrigation fluid.
3.3.2 Precautionary Measures
WARNING!
The pressure chamber diaphragm is fragile and can be replaced if damaged. Re-
placement diaphragms are supplied with reusable tubes. The reusable tube sets
must be prepared before each use. See chapter 7.2 Care and Maintenance of Re-
usable Tube Set for further instructions.
WARNING!
Connecting the tube
The tube outlet may only be connected to instruments which are intended for in-
tra-abdominal fluid suction and irrigation.
WARNING!
The day tube must be replaced at the end of the day of surgery but not later than
after 24 hrs.
WARNING!
The indicated drying time depends on several variables, including the following:
Altitude, humidity, type of packaging, preconditioning, size of chamber, mass of
load, and placement in chamber. Users must verify that the drying time set in
their autoclave yields dry surgical equipment when using the method of saturat-
ed steam sterilization described here.
WARNING!
Connecting the tube
The tube outlet may only be connected to instruments which are intended for in-
tra-abdominal fluid suction and irrigation.