
6
General safety instructions
2.0 For your safety
Riskofinjury!
Danger to the device!
!
• ATMOS neither guarantees for fault-free op-
eration nor for personal injuries 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, exten-
sions and repairs have been carried out by
personnelnotauthorizedbyATMOS.
• The ATMOS Strobo 21 LED is:
- designed in line with IEC 601 / EN 60601.
- assigned to VDE safety class I
- and the class I (93/42/EEC).
• The ATMOS Strobo 21 LED meets the
immunity to interference requirements of IEC
601-1-2 / EN 60601-1-2 “Electromagnetic
Compatibility – Medical Electrical Devices".
• Pleasecheckthedeliveryoncompleteness
and intactness.
• Please note:
A medical insulating transformer with earth
leakagemonitororanysimilarsafetysystem
acc. to EN 60 601-1 is required if several
devices are connected over one common
power supply. The transformer must corre-
spond to the power consumption of all the
devices to be connected.
• The ATMOS Strobo 21 LED may only be
usedunderthesupervisionofskilledsta
whohavebeenauthorizedbyATMOSand
trained in its operation (IEC 601-1 / EN
60601-1).
• There are no warranty claims whatsoever on
defects which arise from the use of third-par-
ty accessories or consumables.
• When connecting several devices on one
grounding receptacle, the allowed strain and
leakagecurrenthavetobeobserved.
• Pay also attention to the safety information of
the attached devices / parts as well as to the
safety information in the following chapters.
• The ATMOS Strobo 21 LED may be operat-
ed only in rooms used for medical purposes,
butnotinareassubjecttoexplosionhazards
and in oxygen-rich environments.
• All additional equipment which is connected
to the analogue and digital interfaces of
the device must meet the requirements of
relevantENspecications(e.g.EN60950
for data processing equipment and EN
60601 for electrical medical equipment). In
addition,congurationsmustsatisfysystem
specicationEN60601-1-1.Whenadditional
equipment is connected to the signal input or
signal output section on the device, the per-
son carrying out the connection is deemed „a
systemcongurationoperator“andassuch
is responsible for meeting the requirements
ofsystemspecicationEN60601-1-1.For
answers to additional questions, please
contact your local specialist supplier or the
ATMOS Technical Service.
• Report all serious incidents that have oc-
curred in connection with this product to the
manufacturer and your national competent
authority.
• Do not allow any liquid to get into the device.
If liquids have penetrated the device, it
may not be operated again until it has been
checkedbythecustomerservicecentre.
• If the endoscope is used combined with
energetic operated accessories the patient
leakagecurrentcansumup.
• Neverlookdirectlyintothelightsource!
• Never touch the device’s interfaces and the
patient at the same time!
• Priortorststartingup,allconnectingleads
mustbecheckedondamage.Damaged
cablesmustbereplaced!Checkfunctionsof
the device prior to use.
• The treating doctor is responsible for the
proper procedure and technology! The
appropriatenessandthekindofapplication
must be decided by a trained doctor on a
case-by-case basis.
• Priortocleaning,switchothedeviceand
separate it from the mains supply respective-
ly from other devices.
• Thexationofmicrophonemayjustbe
tightened enough as absolutely necessary
for the function.
• Only endoscopes which previously have
been cleaned and disinfected may be stored
in the endoscope quivers.
• To disconnect the device from the mains
supply,rstremovetheplugfromthewall
outlet. Then disconnect the power cable from
the device. Never touch plug or cable with
wet hands!
• The ATMOS Strobo 21 LED may be operated
only in rooms used for medical purposes, but
notinareassubjecttoexplosionhazards.
• Explosion-hazardousareasmaybecaused
bytheuseofammableanaesthetics,skin
cleansingproductsandskindisinfectants.
• Priortoeachusechecktheoutersurfaceof
all endoscope parts and endoscopic used
accessories parts which are implemented
inthepatient.Makesurenoharshsurface,
sharp-edged angles or salient parts are
existing, they may cause a danger.
• Please observe, it could happen that body
parts get caught in the foot controller!
• Switchothedevicewhenyounishyour
daily business.
• Wheninstallingtheunit,makesurethat
there is enough cooling air supply.
• The ATMOS Strobo 21 LED System may
not be operated with devices not comply-
ing with the requirements of standard EN
60601-1“Medical Electrical Equipment“ and
EN 60601-1-2 “Electromagnetic Compatibili-
ty“ (Medical Electrical Equipment).
• The device may only be connected to a prop-
erlyinstalledprotectivecontactsocket.
• For mains supply, only use the power cable
supplied (or an equivalent one).
• Pay attention to the ambient conditions spec-
iedinchapter8.0.
• Please pay attention to the period tests in
chapter 6.0 „Service and maintenance“.
• Priortorststartingup,checkwhetherthe
mainsvoltagespeciedonthetypeplate
matches the local mains voltage.
• Checkproperassignmentwhenassembling
country-specicconnections:
- green/yellow: protective conductor (PE)
- blue: neutral conductor (N)
-blackorbrown:phase(L)
• Protect the device against direct solar radia-
tionandkeepitawayfromheaters.
• Always set up the device in such a way that
the operating elements are in clear view and
within easy reach of the operator.
The device must be placed on a stable, level
surface.