Safety Advice - Atmos Variotherm plus Operating Instructions Manual

2.0

2.0 Safety advice

 The Variotherm plus unit is produced according to IEC 601/
EN 60601 and listed in the following classes:
• VDE Class of protection 1
• Class IIa (EEC 93/42).
 The appliance may be connected only to a socket outlet with
earthing contact installed according to the rules of the
trade.
 The unit is only to be installed by a specialist authorized
by ATMOS (see chapter 3.3).
The Variotherm plus may be used in supervised operation

by qualified personnel only which has been authorised by
ATMOS and which has been trained for operating the
appliance (IEC 601-1/EN 60601-1).
 The mains voltage specified on the type plate must
correspond with the data of the power supply system.
 Make sure prior to every application of the equipment that it
is technically safe and in proper condition. Damaged leads
must be replaced immediately!
 Correct configuration in assembly of country-specific con-
nections
green/yellow:
blue:
black resp. brown:
 It is essential that the country-specific requirements for
connection of medical equipment to the public drinking
water supply are considered.
When in doubt, please contact your local ATMOS partner.
 The control panel must be well visible to and in reach of the
operator. Pay attention to sufficient stability of the place of
installation.
 In the thermal process for reducing bacterial count hot

water is being ducted through the irrigation handle. Please
do not take the handle from its holder or spray water!
 Metal parts can be hot!

 Prior to spraying, the water temperature must be checked

by the user!
 Switch off main switch after finishing work in practice and
close water cock of water supply.
 The Variotherm plus may be operated only in rooms used
for medical purposes, but not in areas subject to explosion
hazards and in oxygen rich environments.
12
protective conductor (PE)
neutral conductor (N)
phase (L)
UK
 Additional equipment, which is to be connected to the ana-
log and digital interfaces of the appliance, must provably
meet the requirements of relevant EN specifi-cations (for
inst. EN 60950 for data processing equipment and EN
60601 for electrical medical appliances). Furthermore, all
configurations must satisfy system specification EN 60601-
1-1. Whoever connects additional equipment to the signal
input or signal output section is a system configuration ope-
rator and as such responsible for meeting the requirements
of system specification EN 60601-1-1. In case of further
questions please contact your local specialist supplier or
the technical service.
 The irrigation jet must not get into contact with contaminated
material.
 Application of the warm water jet only with tube tip put
on !
 Caution to be paid to avoid injury to eardrum when
introducing the jet !
For hygienic reasons jet connections must be changed

after each patient. This prevents also retrograde ger-
mination of the warm water system.
 Use only for irrigation of auditory canal !
 ATMOS is not liable for personal injury and damage to
property if
• no original ATMOS parts are being used,
• the advice for use in these operating instructions is not
being observed,
• assembly, new settings, alterations, extensions and repairs
have been carried out by personnel not authorised by
ATMOS.
 The validity for the enclosed certificate of conformity ex-
pires if the customer himself or a third party mani-pulates
the appliance, e.g. with modifications of any kind, by
installing non-authorized accessories, removing danger
and information signs as well as in case of inappropriate
applications.
 Please note:
A medical insulating transformer with earth leakage
monitor or any similar safety system acc. to EN 60 601-1 is
required, if several devices are connected over one com-
mon power supply. The transformer must correspond to the
power consumption of all the devices to be connected.
 The flow rate has to be checked after switch on or
at least once a day with a measuring cup. The quantity
of 500 ml/min may not be exceeded. The water jet has
to be straight.
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