Ambient Conditions - CareFusion Vyntus WALK Instrucciones De Uso

Instructions for Use Vyntus WALK
Page 38/332
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Electrical Safety
As far as Protection Category I equipment/systems are concerned, their touchable
and maybe voltage-carrying metal parts are electrically conductively connected to
each other and connected to the grounding cable of the mains power supply.
A circuit breaker will be tripped should the insulation fail.
Do not perform a measurement during charging process.
Patient Safety according to EN 60601-1
With your CareFusion unit the patient is as safely insulated from the mains
voltage as required in the safety regulations on leakage current according to EN
60601-1.
Nevertheless, a patient environment must be defined. That means the patient
has to keep a distance of at least 1.5 meters from all open interfaces, connectors
and information processing devices (e.g. PC, monitor) to avoid any contact with
electrical voltage. The physician/operator must not touch any voltage-carrying parts
and the patient at the same time.
Valid for all CareFusion Devices
The installation of the ME (medical electrical) system must be performed by
authorized personnel only.
The medical system of CareFusion consists of medical products and EN 60950
components.
Additional equipment connected to medical electrical equipment must comply
with the respective EN (IEC) or ISO standards (e.g. EN 60950 for data processing
equipment). Furthermore all configurations shall comply with the requirements
for medical electrical systems ((section 16 of the 3rd ed. of EN 60601-1). Anybody
connecting additional equipment to medical electrical equipment configures a
medical system and is therefore responsible that the system complies with the
requirements for medical electrical systems. Attention is drawn to the fact that
local laws take priority over the above mentioned requirements. If in doubt,
consult your local representative or the CareFusion Global Customer Support.
Radiated Interference
This medical device meets the regulations according to EN 60601-1-2 regarding
the interference radiated and received.

Ambient Conditions

The medical device must not be operated in rooms or in the presence of
flammable anesthetic mixture with air or flammable anesthetic mixture with
oxygen or nitrous oxide.
If gases and pharmacological substances (aerosol) are used, a good ventilation is
necessary.
The medical device must be operated in rooms where only non-conductive
pollution occurs; however, occasional temporary conductivity due to condensation
is to be expected. The medical device is designed for operation in medically used
rooms.
Version 05.00 • 06-06-2017