Atmos HL 21 Bedienungsanleitung
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 Dierentvariantsoftheheadlamp
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
headlampATMOSHL21LEDsafely,correctly,andeectively.
- 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.
• ThequalitymanagementsystemusedatATMOShasbeencertiedforquality
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:
• Identiesalist
- 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 UniqueDeviceIdentierofa
medical device
MD Medical device
1.0 Introduction
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
rechargeable LED battery
Connection for charging power
pack with polarity marking
Test button for battery test
ECO Half performance
5
1.0 Introduction
OLampisswitchedo
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 identier
(01) UDI-DI:Identicationofthemanufacturerandthedevice
(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
xationontheheadofexaminer
Intended purpose: Illuminationoforices(e.g.ear/nose/throat)for
visual diagnostics
Intended Users / User prole: 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/specic 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.
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
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!
• Duringeachapplication,payattentiontopropertoftheheadlampATMOSHL21
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
quicklywhenthebatterygoesat.
• If the headlamp ATMOS HL 21 LED is used by several users, regular cleaning and
disinfection must be carried out.
• SwitchotheheadlampATMOSHL21LEDwhennotinuse.
• 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
Dierentpowerplugsforchargingpowerpack(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
Priortorstoperation,payattentiontothesafetyinformationinchapter2.0.
Priortousingtheheadlampforthersttime,chargetheLEDbatterybymeansofthe
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
comfortableandcorrecttbymeansoftheturningknob( 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
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