Atmos LS 21 LED Manuel utilisateur
ATMOS LS 21
LED
Light source
GA1GB.150302.0
2021-06 Index: 16
Operating Instructions
English
3
Table of contents
1.0 Introduction.........................................................4
1.1 Notes on operating instructions ............................4
1.2 Explanation of pictures and symbols ....................4
1.3 Intended use .........................................................6
1.4 Function ................................................................6
2.0 For your safety....................................................7
3.0 Scope of supply and connection.......................8
4.0 Operation.............................................................9
4.1 Attaching the application part................................9
4.2 Connection possibilities of the light source...........9
4.3 Operation of the optional LED battery.................10
4.3.1 Indication of capacity ..........................................10
4.3.2 Reloading the LED battery..................................10
4.3.3 Maintenance of battery .......................................10
5.0 Cleaning.............................................................11
6.0 Repairs and servicing.......................................12
6.1 Sending in the device..........................................12
7.0 Troubleshooting................................................12
8.0 Accessories.......................................................13
9.0 Technical data ...................................................14
10.0 Disposal.............................................................14
11.0 Notes on EMC....................................................15
4
1.1 Notes on operating instructions
1.0 Introduction
These operating instructions contain important notes on how to operate the ATMOS LS 21 LED safely,
correctly, and eectively. Their reading helps to avoid risks, and also to reduce repair costs and down-
times. This increases, amongst other things, the reliability and service life of the device.
These operating instructions serve not only for new operating personnel to be instructed in its use, but
also for use as a reference manual. Reprints (also in extracts) only with permission in written form by
ATMOS.
These operating instructions must always be kept available near the device.
• This device bears the CE marking CE in accordance with the European Medical Device Regulation
(MDR) 2017/745.
• The product ATMOS LS 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 declaration of conformity and our general standard terms and conditions can be obtained on our
website at www.atmosmed.com.
• The quality management system applied at ATMOS has been certied according to international
standards EN ISO 13485.
• Prior to start-up, please peruse chapter 2.0 “For your safety” in order to be prepared for any possible
dangerous situations.
These operating instructions are valid for the following devices:
ATMOS LS 21 LED 507.4600.0
ATMOS LS 21 LED, warm white 507.4602.0
ATMOS LS 21 LED 541.4300.0
ATMOS LS 21, warm white 541.4400.0
ATMOS LS 21 LED set, white 507.4610.0
ATMOS LS 21 LED set, warm white 507.4615.0
ATMOS LS 21 LED 600.0011.0
1.2 Explanation of pictures and symbols
On devices, type plates and packaging
Consult operating instructions
Warning, pay special attention
This device complies with the relevant re-
quirements of EU regulations.
This device complies with the relevant require-
ments of the Eurasian Economic Union.
Manufacturer
CC
Date of manufacture
Country of manufacture
REF Reference number
SN Serial number
UDI Unique Device Identier of a medical device
MD Medical device
Humidity limitation
700
1060
Atmospheric pressure limitation
Temperature limit
Professional disposal
Keep dry
Fragile, handle with care
5
1.0 Introduction
Handle with care
Type BF applied part
Connection for lamp to LED battery
Connection for charging power pack with
polarity marking
Test button for battery test
Recyclable
UDI application identier
(1) UDI-DI: Identication of the manufacturer and
the device
(11) Date of manufacture
(21) Serial number
6
1.4 Function
The device is intended to illuminate natural orices (e.g. ear/nose/ throat) for visual diagnosis.
The product is an electrical product. It contains an LED whose luminous ux is focused on a small diameter output. Here, instru-
ments can be adapted for illumination.
1.3 Intended use
Name: ATMOS LS 21 LED
Main function: LED cold light source for optical instruments.
Intended use / intended purpose: Illumination of natural orices (e.g. ear/nose//throat) for diagnosis.
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 depart-
ments, medical care centers
Patient selection criteria: None
Indications: Light source may be used along with other instruments for visual inspection of
anatomy.
Medical contraindications: None
Other contraindications: 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.
1.0 Introduction
7
!
General safety information
Risk of injury! Danger to the device!
• Please make sure that the ATMOS LS 21 LED is used
in an EMC area described in the appendix.
• Please use the ATMOS LS 21 LED light source only in
connection with the rechargeable ATMOS LED battery
or ATMOS current sources.
• Pay also attention to the safety information of the
attached devices/parts as well as to the safety informa-
tion in the following chapters.
• The ATMOS LS 21 LED may be operated only in rooms
used for medical purposes, but not in areas subject to
explosion hazards and in oxygen-rich environments.
• Make sure prior to every application of the equipment
that it is technically safe and in proper condition. Dam-
aged cables must be replaced immediately!
• Pay attention to the correct t of the light source in the
holders.
• Prior to starting up the ATMOS LS 21 LED light source,
read these operating instructions carefully.
• Attention: The light handle gets warmer during applica-
tion.
• ATMOS is not liable for personal injury and damage to
property or malfunctions if:
- no original ATMOS parts are being used
- the advice for use in these operating instructions is
not being observed,
- assembly, new settings, alterations, extensions
and repairs have been carried out by personnel not
authorized by ATMOS.
• Report all serious incidents that have occurred in con-
nection with this product to the manufacturer and your
national competent authority.
• 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! Never look directly into the
light source!
> EYE INJURY
• There are no warranty claims whatsoever on defects
which arise from the use of third-party accessories or
consumables.
• For cleaning, never use alcohol or alcoholic cleaning
agents. Avoid any contact of the lens with alcohol!
2.0 For your safety
8
3.0 Scope of supply and connection
Scope of delivery
Operating
Instructions
.....
ATMOS LS
21 LED
Endoscope
adapter Wolf
Danger to the device!
CAUTION!
• If the light source is used with unsuitable adapters, the lens could be badly damaged!
- Use optics only with the supplied and/or optional adapters!
- Make sure the endoscopes with adapter engage in the light source!
!
9
4.1 Attaching the application part
4.0 Operation
click
Endoscopes
ATMOS Strobo 21 LED
...
ATMOS LS 21 LED
light source
Endoscopes with light conduct-
ing cable
LED battery
4.2 Connection possibilities of the light source
OR
Adapter Storz
Adapter Wolf
10
4.3 Operation of the optional LED battery
4.3.1 Indication of capacity
During charging process
Check regularly!
At the end of the battery capacity, the light expires quickly.
• We therefore recommend:
Change or reload battery
Test button
Indication of the
battery capacity
Keep pressed
For 3 s:
Indication of battery capacity
4.3.2 Reloading the LED battery
• Use the primary adapter tting your power supply (Euro/US/UK/Aus).
• During charging, operation of the headlight is not possible!
Connection LED
light source
Connection charging
power pack
4.0 Operation
Constant indication
of the current battery
capacity
Fully charged: when all 5
LEDs expire again
1
2
4.3.3 Maintenance of battery
During storage During usage
Do not:
• “Suck it out”! When the capacity indication shows “emp-
ty” (all LEDs are out), do not use the battery any more.
- Recharge immediately! For awless operation, the
battery needs a residue capacity.
• Expose the battery to solar radiation or put it close to
heaters.
- This will reduce the lifespan of the battery.
After approx. 500 charging cycles, the battery is at.
• Get a replacement in time.
Do not: Always do:
• Store discharged over a
longer period of time.
• Do not continuously con-
nect the light handle to the
recharging unit. Over-
charging will destroy the
batteries.
• Store in charged condi-
tion.
• Charge at least all 3
months.
The cooler you store the LED battery, the longer it works.
• Store frost-free!
• Store charged up and cool (e.g. in the fridge).
!
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