Atmos HL 21 LED Unit set User manual
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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
11
Fig. 3.
Cable holder
Cable clip
Front pad
Headlampconnection
4
5
6
7
Fig. 4. Connection of LED battery
• TakeoneoftheenclosedconnectingcablesandjoinittotheATMOSHL21LED
headlampconnection( 7,Fig.3).
• UsetheshortconnectingcableifyouwanttocarrytheLEDbatteryonthehead-
band(Fig.8,page13).
• UsethelongconnectingcableifyouwanttocarrytheLEDbatteryinyourcoat
pocket,inyourtrouserpocket,oronyourbelt.Thiscableisalsotobeusedifthe
headlampistobesuppliedfromanATMOSpowersource.Ifnecessary,leadthe
cableunderthefrontpadandthroughthecableholdersinthejointoftheATMOS
HL21LEDheadlamp.
• Usetheenclosedcableclip( 5,Fig.3)toxthelongcabletoyourclothes.
• Connect the other end of the connecting cable to the socket on the LED battery
(Fig.4)orthepowersourceinyourATMOSENTtreatmentunit.
• NOTE:Withitsrearcableclip,therechargeableLEDbatterycanbexedto
yourcoatpocket,toyourbeltortothebatteryholderontheATMOSHL21LED
headlamp.
3.0 Setting up and starting up
12
3.3 Functionality of the LED battery
3.3.1 Capacity indication
ChargingoftheLEDbatterymustbecheckedregularly,asthelightgoesoutvery
quicklywhenthebatterygoesat.Werecommendexchangingorchargingthebattery
when the capacity is < 50%.
• Aslongasthetestbutton( 1,Fig.5)oftherechargeableLEDbatteryispressed,
thebatterycapacityisshownforapprox.3seconds( 2,Fig.5,greenLEDsfor
levels1...5).
3.3.2 Charging the LED battery
• Usetheprimaryadaptersuitableforyourpowersupply(Euro/US/UK/Aus).See
information enclosed with the charging power pack.
• TochargetheLEDbattery,disconnectitfromtheATMOSHL21LEDheadlamp.
• Connecttheroundconnectorofthepowerpackcabletothesocket( 2,Fig.6)of
the LED battery.
• Duringthechargingprocess,thecurrentbatterycapacityisindicated( 2,Fig.5,
greenLEDsforlevels1...5).ThebatteryisfullychargedwhenallveLEDsgoout
again.
Duringcharging,operationoftheheadlampisimpossible!
Fig. 6.
Connecting socket for headlamp
Charging socket of LED battery
1
2
Fig. 5.
Test button
Indication of the battery capacity
(greenLED)
1
2
3.0 Setting up and starting up
13
4.0 Operation
4.1 Diff erent variants of the ATMOS HL 21 LED headlamp
• Fig.7:ATMOSHL21LEDheadlampwithlongcable,supplyfromtheLEDbatteryin
thecoatpocketorfromasuitableATMOSpowersourceinanENTtreatmentunit.
AlsopayattentiontotherespectiveoperatinginstructionsoftheATMOSENTtreat-
ment unit.
• Fig.8:ATMOSHL21LEDheadlampwithshortcable,LEDbatteryinbatteryholder
of the headlamp.
• Toremovethebatteryholder,proceedasfollows:
-Usethelockingscrewtoadjusttheheadlampframequitetight.
- Remove the central cover in the locking screw and then take a Phillips-head
screwdriver to remove the screw.
- Remove the locking screw and remove the battery holder.
-Addthelockingscrewagain.Makesurethatthetightadjustmentofthehead-
lampframehasnotchanged.Otherwise,theheadlampframemustbepushed
together again.
- Insert the screw and replace the cover cap.
Fig. 7. Headlamp without battery holder Fig. 8. Headlamp with battery holder
14
Fig. 9. Focusing
Headlampframe
Focusing ring
1
2
4.2 Switching on
• Adjust the lateral switch on the LED battery to the desired position:
- ECO mode:Operationforapprox.4hours.
- POWER mode:Operationforapprox.2hours.
4.3 Focusing the headlamp
• Thesizeofthelightspotcanbeadjustedbyturningthefocusingring( 2,Fig.9).
4.0 Operation
15
The described measures relating to cleaning and disinfection do not replace the valid
regulations for operation!
Always comply on principle with the operating instructions of the manufacturer regard-
ing concentration and material compatibility.
Do not use any:
• disinfectants containing concentrated organic or inorganic acids or bases since they
may cause corrosion damage.
• Disinfectantscontainingchloramines,phenolderivatives,oranionicsurfactants
since these may cause stress cracks in the plastics used.
IftheATMOSHL21LEDheadlampisusedbyseveralusers,regularcleaningand
disinfection must be carried out.
Do not touch the lens in the light object.
Fingerprintscanberemovedwithasoftcloth.Ifnecessary,youmayuseethanol.
• Thesurfacescanbecleanedwithamoistcloth.Ifnecessary,youmayuseethanol.
• TheATMOSHL21LEDheadlampcannotbesterilised.
• The light body and the rigid headlamp frame can be wiped on the outside with
aclothmoistenedwithasurfacedisinfectant(seechapter5.1).
• Thefrontpadcanbecleanedusingabrush,clearwater,andsoap.Ifnecessary,
you may use a 70%-ethanol solution. The cleaning agent must not contain toluene.
The front pad may also be washed in the washing machine at 30 °C. It must not be
spin-dried or be put in the tumble dryer.
5.1 Recommended surface disinfectants
Disinfectant Ingredients (in 100 g) Manufacturer
Incidin®Plus
(Applicationconcentrate)
Glucoprotamin
Non-ionic surfactants
Solvents,complexingagents
26.0 g Henkel,
Düsseldorf
Dismozon®pur
(Applicationconcentrate)
Endofproduct12/2014
Magnesiummonoperoxyphthalate
hexahydrate
80 g BodeChemie,
Hamburg
Dismozon®plus
(Applicationconcentrate)
Magnesiummonoperoxyphthalate
hexahydrate
95.8 g BodeChemie,
Hamburg
Green&CleanSK
(Applicationconcentrate)
Alkyldimethylbenzylammonium
chloride
Dialkyl-dimethyl-ammonium chloride
< 1 g Metasys,Rum
(Austria)
5.0 Cleaning and care
16
• Priortoeachapplication,checkthedevice'sfunctionsanditspropercondition.
Damaged cables must be replaced immediately!
• TheATMOSHL21LEDheadlampislow-maintenance.Theinstructionsandregula-
tionsfortherespectiveeldofapplicationshouldbeobserved.
• Maintenance,repairsandperiodtestsmaybecarriedoutonlybypersonswhohave
the appropriate technical knowledge and are familiar with the product. The person in
questionmustpossessthetestdevicesandoriginalsparepartsrequiredtotakethe
mentioned measures.
ATMOSrecommendcommissioninganauthorizedATMOSservicepartner.Thiswill
ensurethattherepairsandtestsarecarriedoutappropriately,originalspareparts
areusedandanywarrantyclaimsremainunaected.
• Pleasecomplywiththecountry-specicguidelinesregardingregulartesting,espe-
ciallywithregardtoelectricalsafety.ATMOSrecommendatestevery24months.
• ThisdevicecanbereturneddirectlytoATMOSforrepairs.
• ATMOSneitherguaranteefault-freeoperationnorassumeanyliabilityforpersonal
injuries and damage to property if:
- NooriginalATMOSpartsareused.
- The instructions for use included in these operating instructions are disregarded.
- Assembly,newsettings,alterations,extensionsandrepairsarecarriedoutby
ATMOSauthorisedpersonnel.
• No warranty rights shall exist in the event of damage or failure caused by the use of
non-ATMOSaccessoriesornon-ATMOSconsumables.
• Batteries are wearing parts and therefore excluded from the general two-year prod-
uct liability!
6.0 Maintenance and service
17
6.1 Sending in the device
• Clean and disinfect the product and accessories in accordance with the operating
instructions.
• Enclose any used accessories with the product.
• FillintheQD434form“DeliveryComplaint/ReturnShipment”andthecorrespond-
ing decontamination certicate.
)This form is enclosed with each delivery and can be found at www.atmosmed.com .
• The device must be well padded and packed in suitable packaging.
• PlacetheQD434form“DeliveryComplaint/ReturnShipment”andthecorrespond-
ing decontamination certicate in an envelope.
• Axtheenvelopetotheoutsideofthepackage.
• SendtheproducttoATMOSoryourdealer.
6.0 Maintenance and service
18
8.0 Accessories
7.0 Troubleshooting
Description .................................................................................................REF
Lithium-ion battery.............................................................................507.4510.0
TheATMOSHL21LEDwassubjectedtothoroughqualitycontrolatthefactory.If,
however,anyproblemsshouldoccur,youmaybeabletoeliminatethemyourselfby
observing the following notes.
Error symptom Cause of error Troubleshooting
No light LEDbatteryisat
Cable is not connected properly
Cable is defective
Charge LED battery
Connect cable
New cable
LED battery cannot
be charged
LED battery is defective
Charging power pack is defective
New battery
New charging power pack
19
Voltage Batteryrechargingunit:100-240V~50/60HZ;
secondary,12VDC
LEDbatteryChargewith12VDClithium-ionbatterywith
3.7Vnominalvoltageanda2200mAhcapacity
Current consumption Battery recharging unit: 0.8 A via non-medical 1.8 m
cable with 5.5 x 2.5 mm DC plug
Headlamp:max.700mADC
Power consumption Light emitter 3 watts
Light intensity 100,000lux
Lifespan,LED Max50,000h
Light emitter: Whitehigh-performanceLED,type5500K,lightspot
focusing with a diameter of 25 to 55 mm in at a distance
of 25 cm to the eye.
LED battery Approx.120minchargingtimeaftercompletedischarge;
automaticswitchoverbatterytocompensation;
capacityindicationbyveLEDsatthetouchofabutton
andduringthechargingprocess,atleast500charging
cycles possible.
Operatingtime LEDbatteryswitchwithtwooperatingmodes(Powerand
ECO);120minutesofoperationwithfulllightperfor-
mance and at 240 min. with reduced light performance.
Ambient conditions for
transport/storage
• Temperature -30 to +50°C
• Air humidity 5...90% air humidity without condensation
• Pressure At air pressure of 700...1060 hPa
Environmental conditions
for operation
• Temperature +10 to 35°C
• Air humidity 20...80% air humidity without condensation
• Pressure At air pressure of 700...1060 hPa
Maximumoperational
altitude
3000m(NN)
Contamination level 2
Overvoltagecategory I
Dimensions(HxWxD) Headlampframe:Circumference:Adjustablefrom
50–64cm;height92–115mm
Connectingcable:40cm,140cmand200cminlength
Weight With emitter: approx. 200g
Period tests Recommended:Testevery24months/2years.
9.0 Technical data
20
9.0 Technical data
Protection class
(EN60601-1)
II(chargingpowerpack)
Type of protection IP X0
CE mark
IDno.(REF) 530.4020.0ATMOSHL21LED
506.7551.0ATMOSHL21LED
507.4505.0ATMOSHL21LED(examinationset)
507.4506.0ATMOSHL21LED(OTset)
507.4500.0ATMOSHL21LED
Other manuals for HL 21 LED Unit set
2
Table of contents
Other Atmos Headlamp manuals
