Table of contents Introduction........3 Cleaning and disinfection ... 14 1.1 Notes on operating instructions ..3 5.1 Disinfection of the product .....14 1.2 Explanation of pictures and 5.2 Recommended disinfectant ....15 symbols..........4 5.2.1 Surface disinfectant ......15 1.3 Intended use ........6 Maintenance and service ....
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”).
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.
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Specification of the degree of protection against the ingress of solids and IPX0 moisture Type BF applied part Professional disposal Potential equalization Fuse Alternating current On, connected to the power supply Off, disconnected from the power supply Increase color temperature (light becomes whiter) Reduce color temperature (light becomes more yellow) Adjust color temperature Signal input and signal output This side up Handle with care Fragile, handle with care...
UDI-DI: Identification 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 / Illumination of natural orifices for diagnosis (e.g., ear/nose/...
1.6 Transport and storage Only transport the device in a shipping carton which is padded and offers sufficient 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 •...
• 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 •...
• 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 fire hazard! Burns and injuries are possible.
3.1 Device overview Front view Controller C olor temperature Connection a dapter Rear view Connection f I/o for the ATMOS Strobo 21 LED Connection power supply cord Fuses Connection equipotential bonding 3.2 Use with other devices Only qualified personnel may install electrical systems. The manufacturer of a medical electrical system is responsible for ensuring that the performance, installation and commissioning, safety, specifications, and intended use of the ATMOS LS 31 LED are not affected.
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.
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F I/O 2016-10 ATMOS LS 31 LED ATMOS Strobo 21 LED from 2016-10 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 specifications of IEC EN 60601-1.
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.
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.
NOTICE 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.
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 unaffected.
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6. Stick the envelope on the outside of the package. 7. Send the product to ATMOS or to your dealer. Maintenance and service...
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 1.
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 Accessories...
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- specific laws and regulations.
10 Technical data Voltage 100–230 V~ ± 10%; 50/60 Hz Power consumption Max. 55 VA Fuses 2 x T 2.0 A / H Power supply cord 2 m length, earthing contact plug, non-heating Light intensity Max. 150 klx (in 5 cm distance of a 4.7 mm high- performance light guide) Color temperature Adjustable 5500 K to 6500 K Flash frequency 70 to 1000 Hz flash light and continuous light...
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ID no. (REF) 507.4800.0 ATMOS LS 31 LED 531.2100.0 ATMOS LS 31 LED (S 61 Servant vision) 22 Technical data...
It is not suitable for use in the vicinity of HF surgical devices and in settings outside of an HF-shielded room of a magnetic resonance imaging system. The customer or user of the ATMOS LS 31 LED must ensure that the device is used in a prescribed environment.