Atmos LS 21 LED User manual

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 e󰀨ectively. 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 certied 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 Identier 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 identier
(1) UDI-DI: Identication of the manufacturer and
the device
(11) Date of manufacture
(21) Serial number

6
1.4 Function
The device is intended to illuminate natural orices (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 orices (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 / specic 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).
!

11
• For cleaning, never use alcohol or alcoholic cleaning agents. Avoid any contact of the lens with alcohol!
• Please observe the operating instructions for use prescribed by the manufacturers of disinfectants. Pay attention regarding
concentration and material compatibility.
• Do not use:
- disinfectants which contain concentrated organic or inorganic acids as they could cause corrosion damage.
- disinfectants containing chloramides, phenol derivatives or anionic tensides, as these may cause stress cracks in the
material used for the housing of the unit.
• Do not moisten the lens in the light object with liquids.
• The surfaces can be cleaned with a moist cloth.
• The device has to be cleaned and disinfected regularly if it is applied by several users.
Surface disinfectants
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 hexahy-
drate
95.8 g Bode Chemie, Hamburg
5.0 Cleaning

12
6.0 Repairs and servicing
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 test-
ing 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 for the electrical safety. ATMOS rec-
ommends a test every 24 months.
• Make sure prior to every application of the equipment that it is technically safe and in proper condition. Damaged cables must
be replaced immediately!
• The light source ATMOS LS 21 LED is low-maintenance. The instructions and regulations for the respective eld of applica-
tion should be observed.
• Repair work may be carried out only by expert personnel authorized by ATMOS. For this, pay attention to chapter 2.0 “For
your safety”.
• There are no warranty claims whatsoever on defects or malfunctions which arise from the use of third-party accessories or
consumables.
6.1 Sending in the device
• Remove and properly dispose of consumables.
• Clean and disinfect the product and accessories according to the operating instructions.
• Place used accessories with the product.
• 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.
• The device must be well padded and packed in suitable packaging.
• Place the form QD 434 “Delivery complaint / return shipment” and the respective decontamination certicate in an enve-
lope.
• A󰀩x the envelope to the outside of the package.
• Send the product to ATMOS or to your dealer.
The ATMOS LS 21 LED was subjected to a thorough quality control in the factory. If, however, any problems should occur, you
can possibly eliminate these personally by observing the following notes.
Error indication Cause of error Troubleshooting
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 LED battery is required
• New charging power pack is re-
quired
7.0 Troubleshooting

13
8.0 Accessories
Accessories REF
ATMOS LS 21 LED adapter (Storz) 507.4611.0
ATMOS LS 21 LED adapter (ex. light guide Wolf) 507.0949.0
Lithium-ion battery 507.4510.0

14
9.0 Technical data
Voltage Charging power pack 100–240 V~ ± 10%; 50/60 Hz
secondary 12V
LED battery Charging with 12 V DC, max. 0.8 A, lithium-ion battery with 3.7 V nominal
voltage and 1950 mAh capacity; at least 500 charging cycles
Current consumption light emitter 700 mA, max 1000 mA
Power consumption 2 W
Light emitter white LED
Light intensity:
Light ux:
Color temperature:
Min. 220 klx
Min. 175 lm
Typically 6000 K
Light emitter warm white LED
Light intensity:
Light ux:
Color temperature:
Min. 150 klx
Min. 120 lm
Typically 3900 K
Operating time Battery: switch with 2 operating modes (Power and ECO): 240 min operating
time in Power mode and at least 330 min in ECO mode
Ambient conditions for transport/storage
• Temperature
• Humidity without condensation
• Pressure
−10...+50 °C
30...95% air humidity without condensation
at an air pressure of 500...1060 hPa
Ambient conditions for operation
• Temperature
• Humidity without condensation
• Pressure
+10...+35 °C
30...95% air humidity without condensation
at an air pressure of 700...1060 hPa
Maximum operational altitude 3000 m (above MSL)
Contamination level Class 2
Dimensions Max. ø 37 mm, length 104 mm
Weight 200 g (light emitter); 80 g (battery)
Periodic tests: Recommended: Testing every 24 months
Overvoltage category I
Protection class (EN 60601-1) II (Charging power pack)
Degree of protection Type BF applied parts
Type of protection IPX0
Classication according to Annex IX, EC
Directive 93/42/EEC
Class I according to Rule 12
Risk class (according to MDR) Class I according to Rule 13
CE marking
ID no. (REF) 507.4600.0 ATMOS LS 21 LED
507.4602.0 ATMOS LS 21 LED, warm white
541.4300.0 ATMOS LS 21 LED
541.4400.0 ATMOS LS 21 LED, warm white
507.4610.0 ATMOS LS 21 LED set, white
507.4615.0 ATMOS LS 21 LED set, warm white
600.0011.0 ATMOS LS 21 LED
• The light source ATMOS LS 21 LED does not contain any hazardous goods.
• The LED battery (lithium-ion) must be disposed of correctly.
• Device and accessories must be decontaminated prior to disposal.
• Pay attention to a careful separation of the di󰀨erent materials.
• Please observe national disposal regulations.
10.0 Disposal

15
11.0 Notes on EMC
)Medical electrical equipment is subject to special precautions with regard to EMC and must be installed acc. to following
EMC notes.
Guidance and manufacturer’s declaration – ambient conditions
The ATMOS LS 21 LED is suitable for use in the following environments:
• 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.
The customer or user of the ATMOS LS 21 LED must ensure that the device is used in a prescribed environment.
Guidance and manufacturer’s declaration – key features
)Please note the Technical Data in this manual. The essential features are fully usable even in the presence of electromagnet-
ic disturbances.
Guidance and manufacturer’s declaration – electrical components
The ATMOS LS 21 LED has the following electrical components:
Type REF Max. cable length
Power cable 008.0840.0 2 m
Guidance and manufacturer’s declaration – warnings
WARNING
The use of electrical components and accessories other than those specied or provided by the manufacturer may cause
increased electromagnetic interference or reduced immunity to electromagnetic interference and result in faulty operation of the
device.
WARNING
Portable RF communications equipment (e.g. radios, antenna cables) should be used no closer than 30 cm* to any part of the
ATMOS 21 LED, including cables, specied by the manufacturer. Otherwise, degradation of the performance of this equipment
could result.
)*The distance may be reduced at higher immunity test levels.
WARNING
Avoid using this device in close proximity to other devices or with other devices in a stack, as this may cause interference. If use
in the manner described above is nevertheless necessary, this device and the other devices should be observed to ensure that
they are working properly.

ATMOS MedizinTechnik GmbH & Co. KG
Ludwig-Kegel-Straße 16
79853 Lenzkirch / Germany
Phone: [phone]
[email protected]
www.atmosmed.com