Use Instructions

General Information
9
EN
WARNING!
Reprocessing of sterile disposable products
Infection hazard for patients and/or users and impairment of product function-
ality due to reuse. Risk of injury, illness or death due to contamination and/or
impaired functionality of the product! Do not reprocess the product.
WARNING!
Sterilize reusable instruments and tubing before surgery to prevent infections.
Check all the single-use/disposable items before removing them from the pack-
age to ensure that the packaging is intact and that the expiration date is still val-
id.
WARNING!
Do not touch the patient and the On/Off button at the same time.
WARNING!
Disconnecting device from mains power supply
However, the ON/OFF switch does not disconnect the device from the mains
power supply. This requires pulling the plug located in the rear of the device.
WARNING!
Use only parts and/or devices from ME systems (see chapter 20 Glossary) in pa-
tient environments in compliance with the standard IEC60601-1 in the respec-
tive currently valid version.
WARNING!
Connect only items, that have been specified as part of the ME system or speci-
fied as being compatible with ME system.
WARNING!
Additional equipment
Additional equipment connected to medical electrical devices must be demon-
strably compliant with their respective IEC or ISO standards (IEC 60601-1, IEC
60950 or IEC 62368 for data processing equipment). Furthermore, all configura-
tions 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.