Atmos HL 21 LED Unit set User manual

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 Di󰀨erentvariantsoftheATMOSHL21LED
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:
• ATMOSHL21LED(examinationset) 507.4505.0
• ATMOSHL21LED(OTset) 507.4506.0
• ATMOSHL21LED 507.4500.0
• ATMOSHL21LED 530.4020.0
• ATMOSHL21LED 506.7551.0
in connection with the accessories mentioned in chapter 8.0.
• These operating instructions contain important information on how to operate the
ATMOSHL21LEDheadlampsafely,correctlyande󰀨ectively.
- 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,butalsoonthecareandmaintenanceoftheATMOSHL21LEDheadlamp.
Regular cleaning and preventive maintenance work are therefore essential.
• Maintenanceandrepairsmaybecarriedoutonlybyaskilledpersonauthorizedby
ATMOS.
• In case of repairs you should insist that only original spare parts are used. This will
guaranteethatthesafety,readinessforoperation,andvalueofyourdevicewillbe
maintained.
• ThisdevicebearstheCEmarkingCEinaccordancewiththeEuropeanMedical
DeviceRegulation(MDR)2017/745.
• TheproductATMOSHL21LEDcomplieswithallapplicablerequirementsofthe
directive2011/65/EUrestrictingtheuseofcertainhazardoussubstancesinelectri-
calandelectronicequipment(“RoHS”).
• The declarations of conformity and our general terms and conditions can be viewed
on our website at www.atmosmed.com.
• ThequalitymanagementsystemusedatATMOShasbeencertiedforqualityman-
agement in accordance with the relevant international standards.
• Reproduction of these operating instructions — even in part — only with the written
permissionofATMOS.
1.0 Introduction

4
1.2 Explanation of pictures and symbols
In the operating instructions
Abbreviations/symbols in these operating instructions:
• Indicating a list
-Subdivisionofalist/activity
Therecommendedsequencemustbefollowedineachcase!
Important notes!
On the device, type plate and packaging
Consult the operating
instructions
Warning! Pay special attention
This product meets the
relevantrequirementsof
EUstatutoryordinances.
This product meets the
relevantrequirementsofthe
EurasianEconomicUnion.
Manufacturer
Date of manufacture
DE
Date of manufacture
Country of manufacture:
Germany
REF Article number
UDI Uniqueidentierofamedical
device
1.0 Introduction
MD Medicaldevice
SN Serial number
IPX0 Specicationofthedegreeof
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 Halfperformance
OLampisswitchedo󰀨
POWER Full performance
Handlewithcare
Fragile,handlewithcare
Store in a dry place
Protect from sunlight
Temperature limit
Humiditylimitation
700
1060
Atmospheric pressure
limitation
UDI application identi er
(01) UDI-DI:Identicationofthemanufacturerandthedevice
(11) Date of manufacture
(21) Serial number

6
1.0 Introduction
1.3 Intended use
Product name: ATMOSHL21LED
Main functions: MedicalLEDcoldlightsourcewithheadbandfor
xationontheheadoftheexaminer
Intended use / purpose: Illuminationoforices(e.g.ear/nose/throat)for
visual diagnostics
Intended users / user prole: 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: Withoutrestrictions(mainlyear/nose,throat)
Application time: < 60 min.
Application site: Outpatientmedicalfacilities,e.g.ENTpractices,
hospitaloutpatientdepartments,medicalcare
centres
Patient selection criteria: None
Indications: Whenever visual examination is indicated
Medical contraindications: None
Other contraindications: None
Warnings: None
The product is: Active
Sterility / specic 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.
Thedeviceisanelectricalproduct.ItcontainsanLEDwhoseluminousuxisfocused
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
ATMOSHL21
LED headlamp
1 1 1 1 1
Charging
power pack
(Euro/UK/US/Aus)
- 1 1 - -
LED battery - 1 2 - -
Cable,40cm - 1 1 - -
Cable,140cm - - 1 - -
Cable,200cm - - - 1 1
Battery holder 1 1 1 - -
Cable clip - 1 1 1
1.6 Transport and storage
• Priortodispatch,thisATMOSdevicewassubjectedtoanextensivefunctionaltest
andhasbeencarefullypacked.Nevertheless,pleasecomparethecontentsofthe
shipmentoncompletenessimmediatelyuponreceipt(seescopeofsupply).
• Please document and report damages in transit immediately. For complaints or
returndeliveries,pleaseuseenclosedformQD434Delivery complaint / return
shipment.
1.0 Introduction

8
2.0 For your safety
• PriortostartinguptheheadlampATMOSHL21LED,readtheseoperatinginstruc-
tions carefully.
• ATMOSneitherguaranteesforfault-freeoperationnorforpersonalinjuriesand
damage to property if
- nooriginalATMOSpartsarebeingused,
- The instructions for use included in these operating instructions are disregarded.
- Assemblywork,newsettings,alterations,extensionsandrepairsarecarriedout
bypersonnelnotauthorizedbyATMOS.
• No warranty rights shall exist in the event of damage or failure caused by the use of
non-ATMOSaccessoriesornon-ATMOSconsumables.
• PleasemakesurethattheATMOSHL21LEDisusedinthedescribedEMC
environment.
• OnlyusethechargingpowerpacksuppliedbyATMOS.
• UsetheheadlampATMOSHL21LEDonlyinconnectionwiththeATMOSLED
batteryorATMOScurrentsources.
• 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.
• Priortoeachapplication,checkthedevice'sfunctionsanditspropercondition.
Damaged cables must be replaced immediately!
• Duringeachapplication,payattentiontopropertoftheATMOSHL21LED
headlamp.
• Duringsurgery,pleasenotethattheATMOSHL21LEDheadlampisnotsterile.
• 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
• ChargingoftheLEDbatterymustbecheckedregularly,asthelightgoesoutvery
quicklywhenthebatterygoesat.
• IftheATMOSHL21LEDheadlampisusedbyseveralusers,regularcleaningand
disinfection must be carried out.
• Switcho󰀨theATMOSHL21LEDheadlampwhennotinuse.
• Report all serious incidents that have occurred in connection with this product to the
manufacturer and your national competent authority.

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3.1 Individual components of the headlamp
ATMOSHL21LEDheadlamp
Di󰀨erentpowerplugsforchargingpowerpack(Euro/UK/US/Aus)
Chargingpowerpack,12VDC
LED battery
Connectingcables,40cm,140cmand200cmlong
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
Headlampframe
Locking screw for adjusting the circumference
Strap for adjusting the height



1
2
3
Priortotherstoperation,payattentiontothesafetyinformationinchapter2.0.
Priortousingtheheadlampforthersttime,chargetheLEDbatterywiththesupplied
charging power pack.
3.2 Adjustment to head circumference
• First,taketheheadlampframeincl.headlamp( 1,Fig.2)andputitonatablein
front of you.
Adjusting the headlamp frame:
• Dependingontheheadcircumference,adjusttheheadlampframegraduallyto
acomfortableandcorrecttwiththelockingscrew( 2,Fig.2).Theheightofthe
headlampframeisadjustedbymeansofastrap( 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