Atmos HL 21 LED Unit set Manuale utente
Please keep this document for future consultation!GA1GB.150303.0
2023-12 Index: 11
ATMOS
HL 21 LED
MedizinTechnik
Operating Instructions
English
2
Table of contents
1.0 Introduction.........................................................3
1.1 Notes on operating instructions ............................3
1.2 Explanation of pictures and symbols ....................4
1.3 Intended use .........................................................6
1.4 Function ................................................................7
1.5 Scope of supply ................................................... 7
1.6 Transport and storage...........................................7
2.0 For your safety....................................................8
3.0 Setting up and starting up .................................9
3.1 Individual components of the headlamp ..............9
3.2 Adjustment to head circumference .....................10
3.3 Functionality of the LED battery..........................12
4.0 Operation...........................................................13
4.1 DierentvariantsoftheATMOSHL21LED
headlamp ............................................................13
4.2 Switching on........................................................14
4.3 Focusing the headlamp.......................................14
5.0 Cleaning and care.............................................15
5.1 Recommended surface disinfectants..................15
6.0 Maintenance and service .................................16
6.1 Sending in the device..........................................17
7.0 Troubleshooting................................................18
8.0 Accessories.......................................................18
9.0 Technical data ...................................................19
10.0 Disposal.............................................................21
11.0 Notes on EMC....................................................22
3
1.1 Notes on operating instructions
These operating instructions apply to the following devices:
• ATMOSHL21LED(examinationset) 507.4505.0
• ATMOSHL21LED(OTset) 507.4506.0
• ATMOSHL21LED 507.4500.0
• ATMOSHL21LED 530.4020.0
• ATMOSHL21LED 506.7551.0
in connection with the accessories mentioned in chapter 8.0.
• These operating instructions contain important information on how to operate the
ATMOSHL21LEDheadlampsafely,correctlyandeectively.
- Always keep these operating instructions close to the device!
• The device’s operating safety and its readiness for use depend not only on your ex-
pertise,butalsoonthecareandmaintenanceoftheATMOSHL21LEDheadlamp.
Regular cleaning and preventive maintenance work are therefore essential.
• Maintenanceandrepairsmaybecarriedoutonlybyaskilledpersonauthorizedby
ATMOS.
• In case of repairs you should insist that only original spare parts are used. This will
guaranteethatthesafety,readinessforoperation,andvalueofyourdevicewillbe
maintained.
• ThisdevicebearstheCEmarkingCEinaccordancewiththeEuropeanMedical
DeviceRegulation(MDR)2017/745.
• TheproductATMOSHL21LEDcomplieswithallapplicablerequirementsofthe
directive2011/65/EUrestrictingtheuseofcertainhazardoussubstancesinelectri-
calandelectronicequipment(“RoHS”).
• The declarations of conformity and our general terms and conditions can be viewed
on our website at www.atmosmed.com.
• ThequalitymanagementsystemusedatATMOShasbeencertiedforqualityman-
agement in accordance with the relevant international standards.
• Reproduction of these operating instructions — even in part — only with the written
permissionofATMOS.
1.0 Introduction
4
1.2 Explanation of pictures and symbols
In the operating instructions
Abbreviations/symbols in these operating instructions:
• Indicating a list
-Subdivisionofalist/activity
Therecommendedsequencemustbefollowedineachcase!
Important notes!
On the device, type plate and packaging
Consult the operating
instructions
Warning! Pay special attention
This product meets the
relevantrequirementsof
EUstatutoryordinances.
This product meets the
relevantrequirementsofthe
EurasianEconomicUnion.
Manufacturer
Date of manufacture
DE
Date of manufacture
Country of manufacture:
Germany
REF Article number
UDI Uniqueidentierofamedical
device
1.0 Introduction
MD Medicaldevice
SN Serial number
IPX0 Specicationofthedegreeof
protection against the ingress
of solids and moisture
Type B applied part
Professional disposal
Recyclable
Do not look directly into the
light source
Connection for lamp to LED
battery
Connection for charging power
pack with polarity marking
Test button for battery test
5
1.0 Introduction
ECO Halfperformance
OLampisswitchedo
POWER Full performance
Handlewithcare
Fragile,handlewithcare
Store in a dry place
Protect from sunlight
Temperature limit
Humiditylimitation
700
1060
Atmospheric pressure
limitation
UDI application identi er
(01) UDI-DI:Identicationofthemanufacturerandthedevice
(11) Date of manufacture
(21) Serial number
6
1.0 Introduction
1.3 Intended use
Product name: ATMOSHL21LED
Main functions: MedicalLEDcoldlightsourcewithheadbandfor
xationontheheadoftheexaminer
Intended use / purpose: Illuminationoforices(e.g.ear/nose/throat)for
visual diagnostics
Intended users / user prole: Physicians and medical specialists
Intended patient group: All patients without any restrictions
Medical conditions to be
diagnosed, treated, or
monitored:
Diagnostic examination of anatomy of all kinds
Application organ: Withoutrestrictions(mainlyear/nose,throat)
Application time: < 60 min.
Application site: Outpatientmedicalfacilities,e.g.ENTpractices,
hospitaloutpatientdepartments,medicalcare
centres
Patient selection criteria: None
Indications: Whenever visual examination is indicated
Medical contraindications: None
Other contraindications: None
Warnings: None
The product is: Active
Sterility / specic microbial
condition:
Non-sterile
Single-use product /
re-sterilization:
Not a disposable product. Reprocessing accord-
ing to operating instructions.
7
1.4 Function
This product is a cold light source for medical use. The light source can be worn on the
head and enables the illumination of the viewing area for diagnostic purposes.
Thedeviceisanelectricalproduct.ItcontainsanLEDwhoseluminousuxisfocused
on an output of adjustable diameter at a suitable working distance.
1.5 Scope of supply
REF 507.4500.0 507.4505.0 507.4506.0 530.4020.0 506.7551.0
ATMOSHL21
LED headlamp
1 1 1 1 1
Charging
power pack
(Euro/UK/US/Aus)
- 1 1 - -
LED battery - 1 2 - -
Cable,40cm - 1 1 - -
Cable,140cm - - 1 - -
Cable,200cm - - - 1 1
Battery holder 1 1 1 - -
Cable clip - 1 1 1
1.6 Transport and storage
• Priortodispatch,thisATMOSdevicewassubjectedtoanextensivefunctionaltest
andhasbeencarefullypacked.Nevertheless,pleasecomparethecontentsofthe
shipmentoncompletenessimmediatelyuponreceipt(seescopeofsupply).
• Please document and report damages in transit immediately. For complaints or
returndeliveries,pleaseuseenclosedformQD434Delivery complaint / return
shipment.
1.0 Introduction
8
2.0 For your safety
• PriortostartinguptheheadlampATMOSHL21LED,readtheseoperatinginstruc-
tions carefully.
• ATMOSneitherguaranteesforfault-freeoperationnorforpersonalinjuriesand
damage to property if
- nooriginalATMOSpartsarebeingused,
- The instructions for use included in these operating instructions are disregarded.
- Assemblywork,newsettings,alterations,extensionsandrepairsarecarriedout
bypersonnelnotauthorizedbyATMOS.
• No warranty rights shall exist in the event of damage or failure caused by the use of
non-ATMOSaccessoriesornon-ATMOSconsumables.
• PleasemakesurethattheATMOSHL21LEDisusedinthedescribedEMC
environment.
• OnlyusethechargingpowerpacksuppliedbyATMOS.
• UsetheheadlampATMOSHL21LEDonlyinconnectionwiththeATMOSLED
batteryorATMOScurrentsources.
• The disconnection of the charging power pack from the power supply is only guar-
anteed when the charging power pack is unplugged from the power socket.
• Priortoeachapplication,checkthedevice'sfunctionsanditspropercondition.
Damaged cables must be replaced immediately!
• Duringeachapplication,payattentiontopropertoftheATMOSHL21LED
headlamp.
• Duringsurgery,pleasenotethattheATMOSHL21LEDheadlampisnotsterile.
• Always make sure that you do not blind patients with the light source! Watch out
that patients do not look directly into the light source!
- Danger of eye injury
• ChargingoftheLEDbatterymustbecheckedregularly,asthelightgoesoutvery
quicklywhenthebatterygoesat.
• IftheATMOSHL21LEDheadlampisusedbyseveralusers,regularcleaningand
disinfection must be carried out.
• SwitchotheATMOSHL21LEDheadlampwhennotinuse.
• Report all serious incidents that have occurred in connection with this product to the
manufacturer and your national competent authority.
9
3.1 Individual components of the headlamp
ATMOSHL21LEDheadlamp
Dierentpowerplugsforchargingpowerpack(Euro/UK/US/Aus)
Chargingpowerpack,12VDC
LED battery
Connectingcables,40cm,140cmand200cmlong
Cable holder on the headlamp frame
Adjusting instruments of the headlamp frame
1
2
3
4
5
6
7
Fig. 1a + 1b. Individual components
3.0 Setting up and starting up
10
Fig. 2. ATMOS HL 21 LED headlamp
Headlampframe
Locking screw for adjusting the circumference
Strap for adjusting the height
1
2
3
Priortotherstoperation,payattentiontothesafetyinformationinchapter2.0.
Priortousingtheheadlampforthersttime,chargetheLEDbatterywiththesupplied
charging power pack.
3.2 Adjustment to head circumference
• First,taketheheadlampframeincl.headlamp( 1,Fig.2)andputitonatablein
front of you.
Adjusting the headlamp frame:
• Dependingontheheadcircumference,adjusttheheadlampframegraduallyto
acomfortableandcorrecttwiththelockingscrew( 2,Fig.2).Theheightofthe
headlampframeisadjustedbymeansofastrap( 3,Fig.2).
The lower edge of the headlamp frame is to be positioned directly above the ears.
3.0 Setting up and starting up
Altri manuali per HL 21 LED Unit set
2
Indice
Altri manuali Atmos Lampada frontale
