Atmos HL 21 User manual

Please store this document near the device for later use!GA1GB.150303.0
2021-11 Index: 10
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 purpose..................................................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 rechargeable LED battery....12
4.0 Operation...........................................................13
4.1 Di󰀨erentvariantsoftheheadlamp
ATMOS HL 21 LED .............................................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 are valid for 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
headlampATMOSHL21LED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
competence, but also on the care and maintenance of the headlamp ATMOS HL 21
LED. Regular cleaning and preventive maintenance work is therefore essential.
• Maintenance and repairs may only be carried out 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
electrical 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
management 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:
• Identiesalist
- Subdivision of a list/activity.
The recommended sequence must be adhered to in each case!
Important notes!
On device, type plate, and packaging
Consult operating instructions
Warning, pay special attention
This device complies with the
relevant requirements of EU
regulations.
This device complies with the
relevant requirements of the
Eurasian Economic Union.
Manufacturer
Date of manufacture
DE
Date of manufacture
Country of manufacture:
Germany
REF Reference number
UDI UniqueDeviceIdentierofa
medical device
MD Medical device
1.0 Introduction
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
rechargeable LED battery
Connection for charging power
pack with polarity marking
Test button for battery test
ECO Half performance

5
1.0 Introduction
OLampisswitchedo󰀨
POWER Full performance
Handle with care
Fragile, handle with care
Keep dry
Keep away 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 purpose
Product name: ATMOS HL 21 LED
Main functions: Medical LED cold light source with headband for
xationontheheadofexaminer
Intended purpose: Illuminationoforices(e.g.ear/nose/throat)for
visual diagnostics
Intended Users / User prole: Doctors and medical specialists
Intended Patient population: All patients without any restrictions
Medical conditions to
be diagnosed, treated or
monitored:
Diagnostic examination of anatomy of all kinds
Application organ: No restrictions (mainly ear, nose, throat)
Application time: < 60 min.
Application site: Outpatient medical facilities, e.g. ENT practices,
hospital outpatient departments, medical care
centers
Patient selection criteria: None
Indications: Whenever visual examination is indicated
Medical contra-indications: None
Other contra-indications: None
Warnings: None
The product is: active
Sterility/specic microbial
status:
Non sterile
Single use product /
reprocessing:
No single use product. Reprocessing according to
instructions for use.

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
Headlamp ATMOS
HL 21 LED
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
instructions carefully.
• ATMOS cannot guarantee perfect functioning nor will it be held liable for damage to
people or property if
- any non-original ATMOS parts are used,
- the instructions for use contained in these operating instructions are
disregarded,
- assembly, new settings, alterations, extensions, and repairs have been 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 rechargeable
ATMOS LED battery or ATMOS current sources.
• Disconnection of the charging power pack from the power supply is only guaranteed
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headlampATMOSHL21
LED.
• During surgery, please note that the headlamp ATMOS HL 21 LED 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 headlamp ATMOS HL 21 LED is used by several users, regular cleaning and
disinfection must be carried out.
• Switcho󰀨theheadlampATMOSHL21LEDwhennotinuse.
• 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
Headlamp ATMOS HL 21 LED
Di󰀨erentpowerplugsforchargingpowerpack(Euro/UK/US/Aus)
Charging power pack 12 V DC
Rechargeable LED battery
Connecting cable 40 cm, 140 cm and 200 cm long
Cable holder on the headlamp frame
Adjusting instruments on 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. Headlamp ATMOS HL 21 LED
Headlamp frame
Turning knob for adjusting the circumference
Strap for adjusting the height
1
2
3
Priorto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bymeansof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 your head circumference, adjust the headlamp frame gradually to a
comfortableandcorrecttbymeansoftheturningknob( 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

11
Fig. 3.
Cable holder
Cable clip
Front pad
Headlamp connection
4
5
6
7
Fig. 4. Connection of LED light battery
• Take one of the enclosed connecting cables and join it to the ATMOS HL 21 LED
headlamp connection ( 7, Fig. 3).
• Use the short connecting cable if you want to carry the LED battery on the
headband (Fig. 8, page 13).
• Use the long connecting cable if you want to carry the LED battery in your coat
pocket, in your trouser pocket, or on your belt. This cable is also to be used if the
headlamp is to be supplied from an ATMOS power source. If necessary, lead the
cable under the front pad and through the cable holders in the joint of the headlamp
ATMOS HL 21 LED.
• Use the enclosed cable clip ( 5,Fig.3)toxthelongcabletoyourclothes.
• Join the other end of the connecting cable with the socket on the rechargeable LED
battery (Fig. 4) or with the power source in your ATMOS ENT treatment unit.
• Note:Bymeansofitsrearcableclip,therechargeableLEDbatterycanbexedto
your coat pocket, to your belt, or to the battery holder on the headlamp ATMOS HL
21 LED.




3.0 Setting up and starting up

12
3.3 Functionality of the rechargeable LED battery
3.3.1 Capacity indication
Charging of the LED battery must be checked regularly, as the light goes out very
quicklywhenthebatterygoesat.Werecommendchangingorchargingthebattery
when the capacity is <50%.
• As long as the test button ( 1, Fig. 5) of the rechargeable LED battery is pressed,
the battery capacity is shown for approx. 3 seconds ( 2, Fig. 5, green LEDs for
levels 1...5).
3.3.2 Charging the LED battery
• Usetheprimaryadapterttingyourpowersupply(Euro/US/UK/Aus).See
information enclosed with the charging power pack.
• To charge the LED battery, disconnect it from the headlamp ATMOS HL 21 LED.
• Join the round connector of the power pack cable with the socket ( 2, Fig. 6) on the
LED battery.
• During the charging process, the current battery capacity is indicated ( 2, Fig. 5,
green LEDs for levels 1...5). The battery is fully charged when all 5 LEDs go out
again.
During charging, operation of the headlamp is impossible!
Fig. 6.
Connecting socket for headlamp
Charging socket on LED battery
1
2
 
Fig. 5.
Test button
Indication of the battery capacity
(green LED)
1
2


3.0 Setting up and starting up

13
4.0 Operation
4.1 Di󰀨erent variants of the headlamp ATMOS HL 21 LED
• Fig. 7: Headlamp ATMOS HL 21 LED with long cable, supply from the LED battery
in the coat pocket or from a suitable ATMOS power source in an ENT treatment
unit.
Also pay attention to the respective operating instructions of the ATMOS ENT
treatment unit.
• Fig. 8: Headlamp ATMOS HL 21 LED with short cable, LED battery in battery holder
on the headlamp.
• For removing the battery holder, proceed as follows:
- Use the turning knob to adjust the headlamp frame quite tight.
- Remove the center cover in the turning knob and then take a Phillips-head
screwdriver to remove the screw.
- Remove the turning knob and remove the battery holder.
- Add the turning knob again. Make sure that the tight adjustment of the headlamp
frame has not changed. Otherwise, the headlamp frame must be pushed
together again.
- Insert screw and replace the cover cap.
Fig. 7. Headlamp without battery holder Fig. 8. Headlamp with battery holder

14

Fig. 9. Focusing
Headlamp frame
Focusing ring
1
2
4.2 Switching on
• Adjust the lateral switch on the LED battery to the desired position:
- ECO mode: operation for approx. 4 hours.
- POWER mode: operation for approx. 2 hours.
4.3 Focusing the headlamp
• The size of the light spot can be adjusted by turning the focusing ring ( 2, Fig. 9).
4.0 Operation

15
The measures described for cleaning and disinfection are not intended to replace the
regulations applicable for the respective operation!
Always comply on principle with the relevant manufacturer’s information regarding
concentration and material compatibility.
Do not use any:
• disinfectants containing concentrated organic or inorganic acids or bases since
these may cause corrosion damage.
• disinfectants containing chloramines, phenol derivatives, or anionic surfactants
since these may cause stress cracks in the plastics used.
If the headlamp ATMOS HL 21 LED is used by several users, regular cleaning and
disinfection must be carried out.
Do not touch the lens in the light object.
• Fingerprints can be wiped down with a soft cloth. If necessary, you may use
ethanol.
• The surfaces can be cleaned with a moist cloth. If necessary, you may use ethanol.
• The headlamp ATMOS HL 21 LED cannot be sterilized.
• The light body and the rigid headlamp frame can be wiped down on the outside with
a cloth moistened with a surface disinfectant (see chapter 5.1).
• The front pad can be cleaned using a brush, clear water, and soap. If necessary,
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 may not be
spin-dried or be put in the tumble dryer.
5.1 Recommended surface disinfectants
Disinfectant Ingredients (in 100 g) Manufacturer
Incidin®Plus
(Application concentrate)
Glucoprotamin
non-ionic surfactants
Solvents, complexing agents
26.0 g Henkel,
Düsseldorf
Dismozon®pur
(Application concentrate)
End of product 12/2014
Magnesium monoperoxyphthalate
hexahydrate
80 g Bode Chemie,
Hamburg
Dismozon®plus
(Application concentrate)
Magnesium monoperoxyphthalate
hexahydrate
95.8 g Bode Chemie,
Hamburg
Green & Clean SK
(Application concentrate)
Alkyldimethylbenzylammonium
chloride
Dialkyl-dimethyl-ammonium chloride
< 1 g Metasys, Rum
(Austria)
5.0 Cleaning and care

16
• Prior to each application, check the device's functions and its proper condition.
Damaged cables must be replaced immediately!
• The headlamp ATMOS HL 21 LED is low-maintenance. However, the regulations
andinstructionsapplyingtotherespectiveeldofapplicationhavetobeobserved.
• Maintenance, repairs, and periodic tests may only be carried out by persons who
have the appropriate technical knowledge and are familiar with the product. To carry
out these measures, the person must have the necessary test devices and original
spare parts.
ATMOS recommends: work should be carried out by an authorized ATMOS service
partner. This ensures that repairs and testing are carried out professionally, original
sparepartsareused,andwarrantyclaimsremainuna󰀨ected.
• Pleasecomplywiththecountry-specicguidelinesregardingregulartesting,
especially with regard to electrical safety. ATMOS recommends a test every 24
months.
• For repair, this device can be returned to ATMOS.
• ATMOS cannot guarantee perfect functioning nor will it be held liable for damage to
people or property if
- any non-original ATMOS parts are used,
- the instructions for use contained in these operating instructions are
disregarded,
- assembly, new settings, alterations, extensions, and repairs have not been
carried out by personnel 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.
• Rechargeable batteries are wearing parts and therefore excluded from the general
2-year product liability!
6.0 Maintenance and service

17
6.1 Sending in the device
• Clean and disinfect the product and accessories according to the operating
instructions.
• Place any used accessories with the product.
• Fill in form QD 434 “Delivery complaint / return shipment” and the corresponding
Decontamination certicate.
)This form is enclosed with each delivery and can be found at www.atmosmed.com .
• The product must be well padded and packed in suitable packaging.
• Place form QD 434 “Delivery complaint / return shipment” and the respective
Decontamination certicate in an envelope.
• A󰀩xtheenvelopetotheoutsideofthepackage.
• Send the product to ATMOS or your dealer.
6.0 Maintenance and service

18
8.0 Accessories
7.0 Troubleshooting
Description .................................................................................................REF
Lithium-ionic battery ..........................................................................507.4510.0
The ATMOS HL 21 LED was subjected to a thorough quality control in the factory. If,
however, a problem should occur, you may solve it yourself if you follow these notes.
Error symptom Cause of error Remedy
No light LEDbatteryisat
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
Mains voltage Charging power pack: 100–240 V~ 50/60 HZ;
secondary 12 V DC
Rechargeable battery: Charging with 12 V DC, lithium-
ionic battery with 3,7 V nominal voltage and a 1950 mAh
capacity
Current consumption: Charging power pack: 0,8 A via non-medical 1,8 m cable
with DC plug 5,5 x 2,5 mm
Power consumption: Light emitter: 2 watt
Illuminance: 100.000 Lux
Life-span LED Max 50.000 h
Light emitter: White high-performance LED, Type 5500 K, light spot
focusing with a diameter of 25 to 55 mm in 25 cm
distance to the eye
Rechargeable battery approx. 120 Min charging time after complete discharge;
automatic switchover battery to compensation;
capacity indication by 5 LEDs at the touch of a button
and during the charging process, at least 500 charging
cycles possible
Power cycle Rechargeable battery: switch with 2 operating modes
(Power and ECO): 120 min operation with full light
performance and at least 240 min with reduced light
performance
Environmental conditions:
Transport/Storage
• Temperature range −30...+50°C
• Air humidity without
condensation
5...90 %
• Air pressure 700...1060 hPa
Environmental conditions:
Operation:
• Temperature range +10...35°C
• Air humidity without
condensation
20...80 %
• Air pressure 700...1060 hPa
Maximum operating
altitude
3000 m (NN)
Contamination level Class 2
Overvoltage category I
9.0 Technical data

20
9.0 Technical data
Dimensions (H x W x D) Heading rack: Head measurement adjustable from
50–64 cm, level 92–115 mm
Connecting cable: 40 cm, 140 cm and 200 cm long
Weight: With emitter: approx. 200g
Periodical tests: Recommended: Check every 24 months / 2 years.
Protection class against
electric shock (acc to EN
60601-1)
II (Charging power pack)
Degree of protection
against electric shock
Applied parts type B
Degree of protection
against Ingress
IP X0
CE mark
Ident-No. (REF) 530.4020.0 ATMOS HL 21 LED
506.7551.0 ATMOS HL 21 LED
507.4505.0 ATMOS HL 21 LED (examination set)
507.4506.0 ATMOS HL 21 LED (OT set)
507.4500.0 ATMOS HL 21 LED