Use Instructions

General Information
11
EN
scopes must comply with the most recent versions of IEC 60601-2-18 and ISO
8600. Combining/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 15). Care was taken during the development and testing of this de-
vice that electrical interference of or from other devices or instruments was prac-
tically 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
EQUIPMENT or ME SYSTEM (see chapter 20) as replacement parts for internal
components, may result in increased EMISSIONS or decreased IMMUNITY of the
ME EQUIPMENT or ME SYSTEM.
CAUTION!
The medical electrical (ME) device is suitable for integration in ME equipment
systems (see chapter 15). Operation of the ME device in vicinity of non-ME devic-
es may result in voiding the intended use of the ME device.
CAUTION!
Peripheral devices
Additional peripheral equipment connected to interfaces of the medical monitor
has to meet the requirements of the following specifications in the respective
current valid version: IEC 60601-2-18 / EN 60601-2-18 for endoscopic devices
and IEC 60601-1 / EN 60601-1 for electrical medical devices. All configurations
have to comply with IEC 60601-1 / EN 60601-1 specifications. Whoever connects
additional equipment to signal output or signal input is considered the system
configurator and as such is responsible for complying with requirements of the
standard IEC 60601-1 / EN 60601-1.
CAUTION!
The device is transportable. The rollers of the cart/scale system are used for po-
sitioning at the usage site. To transport the device, remove all fluid bags from
the hooks and make sure there are no canisters or only completely emptied can-
isters on the cart/scale. Inflow and outflow tubes must be completely removed.
Make sure power supply line does not touch the ground and there are no other
objects located on the GYN-Pump oder Bilanzierungseinheit. Always use the
handle to move the system safely.