Atmos LS 31 LED User manual

Operating Instructions
ATMOS LS 31 LED
English
GA1GB.150304.0
2021-06 Index 04

2
Table of contents
1 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 delivery ................................7
1.6 Transport and storage .......................7
2 Hints for your safety...................... 8
2.1 General safety information...............8
2.2 Dangers for users, patients, and third
parties..................................................8
2.3 Damage to the device ........................9
3 Setting up and starting up .......... 10
3.1 Device overview ................................10
3.2 Use with other devices.....................10
3.3 Connecting the device .....................11
4 Operation...................................... 13
4.1 Ambient conditions during
operation...........................................13
4.2 Switch on the device ........................13
4.3 Switchothedevice ........................13
4.4 Connect the light guide cable .........13
4.5 Remove the light guide cable..........13
4.6 Adjust the color temperature .........13
4.7 Change the adapter .........................13
5 Cleaning and disinfection ........... 14
5.1 Disinfection of the product .............14
5.2 Recommended disinfectant............15
5.2.1 Surface disinfectant ......................15
6 Maintenance and service............ 16
6.1 Periodic tests.....................................16
6.2 Function check..................................16
6.3 Replacing the fuse............................16
6.4 Sending in the device.......................16
7 Troubleshooting ........................... 18
8 Accessories ................................... 19
9 Disposal......................................... 20
10 Technical data .............................. 21
11 Notes on EMC ............................... 23

3Introduction
1 Introduction
1.1 Notes on operating instructions
These operating instructions contain important notes on how to
operatetheATMOSLS31LEDsafely,correctly,andeectively.
The instructions are intended for the training and teaching of operating
personnel and are intended as a reference. Reproduction, even partial,
is only permitted with written permission from ATMOS.
These operating instructions must always be kept available near
the device.
Care, periodic tests, regular cleaning, and proper application are
indispensable. They guarantee the operational safety and usability of
the ATMOS LS 31 LED.
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.
Read Chapter “2 Hints for your safety” on page 8 before using the
deviceforthersttime.Thishelpsyouavoidpotentiallydangerous
situations.
This device bears the CE marking CE in accordance with the European
Medical Device Regulation (MDR) 2017/745.
The ATMOS LS 31 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atATMOShasbeencertied
according to international standards EN ISO 13485.
These operating instructions are valid for the following devices:
• ATMOS LS 31 LED 507.4800.0
• ATMOS LS 31 LED (S 61 Servant vision) 531.2100.0

4Introduction
1.2 Explanation of pictures and symbols
In the operating instructions
DANGER
Warning of a danger which causes immediate death or serious injury. Observe the
necessary measures.
WARNING
Beware of a danger which can cause death or serious injury. Observe the necessary
measures.
CAUTION
Beware of a danger which can easily hurt you. Observe the necessary measures.
NOTICE
Indication of a danger where the product or other items can be damaged. Observe the
necessary measures.
Warning of a danger which can cause death or serious injury.
Information regarding possible material damage which can be caused.
Useful information on the handling of the device.
1. Action. Go step by step
»Result of an action.
On device, type plate, and packaging
Follow operating instructions (blue)
Observe operating instructions
This device complies with the relevant requirements of EU regulations.
This device complies with the relevant requirements of the Eurasian
Economic Union.
Manufacturer
DE
Manufacturing date
Country of manufacture: Germany
REF Reference number
UDI UniqueDeviceIdentierofamedicaldevice
MD Medical device
SN Serial number

5Introduction
IPX0 Specicationofthedegreeofprotectionagainsttheingressofsolidsand
moisture
Type BF applied part
Professional disposal
Potential equalization
Fuse
Alternating current
On, connected to the power supply
O,disconnectedfromthepowersupply
Increase color temperature (light becomes whiter)
Reduce color temperature (light becomes more yellow)
K
Adjust color temperature
Signal input and signal output
This side up
Handle with care
Fragile, handle with care
Keep dry
Keep away from sunlight
Temperature limit
Humidity limitation
700
1060
Atmospheric pressure limitation

6Introduction
UDI application identier
(01) UDI-DI:Identicationofthemanufacturerandthedevice
(11) Date of manufacture
(21) Serial number
1.3 Intended use
Product name: ATMOS LS 31 LED
Main functions: LED cold light source for optical instruments. Provides
adjustable color temperature and includes an external
trigger function.
Intended use /
intended purpose:
Illuminationofnaturaloricesfordiagnosis(e.g.,ear/nose/
throat)
Intended users / user
prole:
Doctors and medical specialists
Intended patient
population:
All patients without restrictions
Medical condition
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: The light source may be used along with other instruments
for visual inspection of the anatomy.
Medical
contraindications:
None
Other
contraindications:
None
Warnings: None
The product is: Active
Sterility / specic
microbial state:
Non-sterile
Single-use product /
reprocessing:
Not a single-use device. Reprocessing according to the
operating instructions.

7Introduction
1.4 Function
This product is a cold light source for medical use. In combination with a light guide
cable and an instrument connected to it, the light source enables the illumination of the
viewing area for diagnostic purposes.
Thedeviceisanelectricallydrivendevice.ItcontainsanLEDwhoseluminousuxis
focused on a small diameter output. Here, light guide cables can be adapted for the
transmission of light.
1.5 Scope of delivery
ATMOS LS 31
LED
Power supply
cord
Storz adapter Operating
Instructions
1.6 Transport and storage
Onlytransportthedeviceinashippingcartonwhichispaddedandoerssucient
protection.
If damage occurs during transport:
1. Document and report the transport damage.
2. Send the device to ATMOS; see chapter “6.4 Sending in the device” on page 16.
Environmental conditions for transport and storage:
• Temperature: −20...+80°C
• Humidity without condensation: 30...95%
• Pressure: 500...1060hPa

8Hints for your safety
2 Hints for your safety
Please read and pay attention to the safety instructions prior to using the product.
2.1 General safety information
Report all serious incidents that have occurred in connection with this product to the
manufacturer and your national competent authority.
Onlyuseaccessoriesandoptionswhicharespecicallysuitedforcombinationwiththe
product and which meet the performance and safety requirements.
If you wish to connect more than one device or applied part, you must always observe
their safety instructions.
Please ensure that the light source is illuminated even if there is no light guide cable
connected.
2.2 Dangers for users, patients, and third parties
Protect yourself against an electric shock!
Burns and cardiac arrhythmia and even death are possible.
• Disconnect the device from the mains before cleaning or disinfecting it.
• Prior to each use check whether the device is damaged. Do not operate the device
if you notice any damage. In this case, clean and disinfect the device and send it to
ATMOS for repair.
• Only connect the device to a power supply with a protective conductor.
• Never touch the device’s interfaces and the patient at the same time!
• Only use original accessories and original spare parts from ATMOS.
• Please pay attention to the periodic tests in chapter “6.1 Periodic tests” on page
16.
• Do not change the device without the manufacturer's permission.
• Assembly,newsettings,modications,extensions,andrepairsmayonlybecarried
out by authorized persons.
Danger of blinding due to the high light intensity.
Eyeinjuryispossible.Peoplewithoutblinkreexorwithparticularlightsensitivitycould
go blind.
• Never look directly into the light source or in the light guide cable.
• Never direct the light source into the patient’s eyes.
• Never permit the patient to look into the light source or light guide cable.
• Thelightsourcemayonlybeoperatedbyqualiedpersonnel.
Heat development on the light source.
Burns are possible.
• Pay attention to the heat development of the light source.
• Switchothelightsourcewhennotinuse.
• Do not touch the connection for the light guide adapter.
• Do not place the product in a closed environment or beside other heat sources.
The device must always be functional.
Your patient could be injured during the treatment as a result of a missing diagnosis or
light failure.

9Hints for your safety
• ATMOS always recommends having an alternative light source ready to hand.
• Prior to each use, a function check has to be performed.
• Please observe the notes on electromagnetic compatibility (EMC) of the device.
Explosion and re hazard!
Burns and injuries are possible.
• Never operate the device in explosion-hazardous areas or areas which are
oxygenated.
• Only use original accessories and original spare parts from ATMOS.
Only a fully functional product meets the safety requirements of users, patients, and
third parties. Please therefore read the following instructions carefully.
2.3 Damage to the device
Storage and operation in an unsuitable environment.
The electronics could be damaged.
• Please observe the ambient conditions regarding transport, storage, and operation.

10 Setting up and starting up
3 Setting up and starting up
3.1 Device overview
Front view
1
2
3
1Controller Color temperature
2Connection adapter
3on/off key
Rear view
4
5
7
6
4Connection f I/o for the ATMOS
Strobo 21 LED
5Connection power supply cord
6Fuses
7Connection equipotential bonding
3.2 Use with other devices
Onlyqualiedpersonnelmayinstallelectricalsystems.Themanufacturerofamedical
electrical system is responsible for ensuring that the performance, installation and
commissioning,safety,specications,andintendeduseoftheATMOSLS31LEDarenot
aected.
Observe the following information when connecting the device in the required
combination:
• RefertothespecicationsofIECEN60601-1onmedicalelectricalsystems.
• Note in particular the information on the patient environment, multiple sockets, and
leakage current.

11Setting up and starting up
3.3 Connecting the device
Light failure during a treatment.
Your patient could be injured.
• Only connect a stroboscope from ATMOS.
• Only use the provided interlink cable or an original spare part from ATMOS.
Heat development on the light source.
Burns are possible.
• Do not place the product in a closed environment or beside other heat sources.
Carefully read the safety instructions in chapter “2 Hints for your safety” on page 8
before using the product.
Transport damage
1. Check the device for any transport damage.
2. If the device is damaged: document and report the transport damage. Send the
device to ATMOS, see Chapter “6.4 Sending in the device” on page 16.
Connect the adapter
1. Insert a suitable adapter into the connection adapter.
Connect a stroboscope
1. Refer to the guidelines for medical electrical systems in Chapter “3.2 Use with other
devices” on page 10.
2. Connect the ATMOS Strobo 21 LED as follows:
Type of stroboscope Connection
ATMOS Strobo 21 LED with
date of production up to
2016-09
Trigger cable 507.4837.0 (Y-cable):
Connection F I/O 1 1to the connection LED light handle
2and connection F-Out 3.
ATMOS LS 31 LED
ATMOS Strobo 21 LED up to 2016-09
1
3
2
CAUTION

12 Setting up and starting up
Type of stroboscope Connection
ATMOS Strobo 21 LED with
date of construction from
2016-10
Trigger cable 507.4838.0
Connection F I/O 1 1to connection F I/O 4.
ATMOS Strobo 21 LED from 2016-10ATMOS LS 31 LED
1
4
Equipotential bonding and power supply
1. Connect the equipotential bonding if required.
The equipotential bonding must be connected if the spatial environment in which
theproductisusedrequiresthis.RefertothespecicationsofIECEN60601-1.
2. Check that the mains voltage and device voltage match.
The device's details can be found on the type plate.
3. If the mains voltage and mains frequency correspond: connect the device with the
supplied power supply cord to a power supply with a protective conductor.
4. Perform a function check, see Chapter “6.2 Function check” on page 16.

13Operation
4 Operation
4.1 Ambient conditions during operation
• Temperature: +10...+35°C
• Humidity without condensation: 30...95%
• Pressure: 700...1060hPa
4.2 Switch on the device
Prior to each use, perform a function check; see chapter “6.2 Function check” on
page 16.
1. Press the button on/ off.
» The light source is illuminated.
4.3 Switch o the device
1. Press the button on/ off.
» The light source is no longer illuminated.
4.4 Connect the light guide cable
1. Switchothedevice.
2. Insert the light guide cable into the adapter until it engages easily.
4.5 Remove the light guide cable
1. Switchothedevice.
2. Remove the light guide cable from the adapter.
4.6 Adjust the color temperature
1. Turn the controller Color temperature.
Turn it clockwise and the light becomes whiter or anti-clockwise and the light
becomes more yellow.
2. If a camera is connected, perform white balance.
4.7 Change the adapter
1. Switchothedevice.
2. Remove the light guide cable from the adapter.
3. Unscrew the adapter from the adapter connection.
4. Insert the desired adapter into the adapter connection.
5. Insert the light guide cable into the adapter until it engages easily.
Perform a function check; see chapter “6.2 Function check” on page 16.

14 Cleaning and disinfection
5 Cleaning and disinfection
We recommend that you always document all maintenance work and exchange of parts
in writing.
It is the responsibility of the operator to ensure that the required results for cleaning
and disinfection are adhered to. Generally, validation, and routine monitoring of the
procedure are necessary.
Risk of infection due to germs on equipment and accessories.
Diseases may be transmitted.
• Wear disposable gloves during all cleaning and disinfection measures.
• Clean and disinfect the device if required.
• Clean and disinfect the device according to the operating instructions.
5.1 Disinfection of the product
Electric shock caused by liquid inside the device.
Burns and cardiac arrhythmia and even death are possible.
• Do not rinse the device under running water and do not immerse it in liquids.
• Make sure that the cleaning cloth is only damp and not wet.
• Do not subject the device to an autoclave or sterilization.
• Do not immerse the device in disinfectant solution.
Liquid in the light channel.
Damaged lens.
• Please ensure that liquid does not penetrate the light channel.
1. Switchothedevice.
2. Remove the light guide cable.
3. Clean the device with a damp, clean, lint-free cloth.
4. Disinfect the device with a clean, lint-free cloth and a recommended disinfectant.
See chapter “5.2 Recommended disinfectant” on page 15.
Clean and disinfect the light guide cable according to the respective operating
instructions of the manufacturer.
5. Attach the light guide cable.
6. Perform a function check; see chapter “6.2 Function check” on page 16.
WARNING
WARNING
NOTICE

15Cleaning and disinfection
5.2 Recommended disinfectant
Unsuitable disinfectant.
Damage to the device surface, corrosion damage, and stress cracks are possible.
• Only use disinfectants which are recommended by ATMOS.
• Do not use disinfectants which contain the following ingredients:
- Alcohol.
- Organic or inorganic acids or bases.
- Chloramines.
- Phenol derivatives.
- Anionic surfactants
5.2.1 Surface disinfectant
Observe the instructions for use of the disinfectant manufacturers. Note in particular
the information on the concentration and material compatibility.
Disinfectant Ingredients in 100 g Manufacturer
Green & Clean SK Di alkyl dimethyl ammonium chloride < 1 g Metasys, Rum
(Austria)
Alkyl dimethyl ethyl benzyl ammonium
chloride
< 1 g
Alkyl dimethyl benzyl ammonium chloride < 1 g
Dismozon® plus
(Granulate)
magnesium monoperoxyphthalate
hexahydrate
95.8 g Bode Chemie,
Hamburg
Incidin® Plus
(application
concentrate)
glucoprotamin 26 g Ecolab,
Düsseldorf
NOTICE

16 Maintenance and service
6 Maintenance and service
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.
6.1 Periodic tests
At least every 24 months a repeat test of the electrical safety should be performed
according to IEC 62353.
ATMOSrecommendsaninspectionaccordingtothemanufacturer‘sspecications.
6.2 Function check
Prior to each use, a function check has to be performed.
Never operate the device if you detect any damage. In this case, clean and disinfect the
device and send it to ATMOS for repair.
1. Check whether the device, the power supply cord, or connected parts are damaged.
2. Check whether the adapter is connected properly.
3. Connect a light guide cable or check whether the light guide cable is connected
properly.
4. Aim the light guide cable at a white surface.
5. Press the on/off button to switch on the device.
» The light source is illuminated.
6. Turn the controller Color temperature and check whether the light changes accordingly.
6.3 Replacing the fuse
1. Switchothedevice.
2. Remove the power supply cord from the device.
3. Remove the fuse holder from the mains connection.
4. Replace both fuses.
5. Attach the fuse holder.
6. Connect the device to the mains supply.
6.4 Sending in the device
1. Clean and disinfect the products and accessories according to the operating
instructions.
2. Place used accessories with the device.
3. Fill in the form QD 434 “Delivery complaint / return shipment” and the respective
Decontamination certicate.
This form is enclosed with each delivery and can be found at www.atmosmed.com.
4. The device must be well padded and packed in suitable packaging.
5. Place form QD 434 “Delivery complaint / return shipment” and the corresponding
Decontamination certicate in an envelope.

17Maintenance and service
6. Stick the envelope on the outside of the package.
7. Send the product to ATMOS or to your dealer.

18 Troubleshooting
7 Troubleshooting
The ATMOS LS 31 LED was subjected to a thorough quality control in the factory.
However, should an error occur, you may be able to solve this yourself.
Light source
Error indication Possible cause Remedy
No light. Device is not switched
on.
1. Switch on the device.
Device is not connected
to the power supply.
1. Connect the device.
2. Check that the connections are
ttedproperly.
Defective power supply
cord.
1. Change the power supply cord.
Defective fuse. 1. Replace the fuse.
Insucientlight. Adapter is not
connected properly.
1. Checkwhethertheadapteristted
properly.
Adapter is not suitable
for the light guide cable.
1. Use an adapter which is suitable
for the light guide cable.
Light guide cable is
defective.
1. Replace the light guide cable.
The colors are
unnatural.
Color temperature is not
coordinated.
1. Adjust the color temperature.
2. If a camera is connected, perform a
white balance.
Stroboscopy
Error indication Possible cause Remedy
Stroboscopy does
not work.
Trigger cable is not
connected properly.
1. Check the trigger cable.
Pleaseobservethedierenttrigger
cables; see chapter “3.3 Connecting
the device” on page 11.

19Accessories
8 Accessories
Accessories REF
LED Light Cube Adapter ATMOS/Storz 530.6100.0
LED Light Cube Adapter Olympus 530.6101.0
LED Light Cube Adapter Pentax 530.6102.0
LED Light Cube Adapter Wolf 530.6103.0
High-perf.lightguidecable,Ø4.8mm,L=1.8m 950.0152.0
Lightguidecable,Ø3.5mm,L=1.7m 508.0663.0
Lightguidecable,Ø3.5mm,L=1.8m,90°angled 508.0664.0
ATMOS LS 31 LED trigger cable (Strobo up to 09/16) 507.4837.0
ATMOS LS 31 LED trigger cable 507.4838.0

20 Disposal
9 Disposal
Packaging
1. Please recycle the packaging.
ATMOS LS 31 LED
Do not dispose of the device with household waste.
The ATMOS LS 31 LED does not contain any hazardous goods.
1. Clean and disinfect the device.
2. In Germany: send in the device to ATMOS or your specialized dealer. They
will dispose of the device professionally.
3. In other countries: dispose of the device professionally and according to country-
speciclawsandregulations.
In Germany, the device is excluded from the Electrical and Electronic Equipment Act
(ElektroG) in accordance with the National Register for waste electric equipment
because it may be contaminated. Do not dispose of the device with electronic waste.
Thehousingisfullyrecyclable.Refertothecountry-speciclawsandregulations.