ATMOS HL 21 LED Operating Instructions Index 10 Nov 2021

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Table of contents

1.0 1.1 1.2 1.3 1.4 1.5 1.6

Introduction...3 Notes on operating instructions...3 Explanation of pictures and symbols...4 Intended purpose...6 Function...7 Scope of supply... 7 Transport and storage...7

2.0

For your safety...8

3.0 3.1 3.2 3.3

Setting up and starting up...9 Individual components of the headlamp...9 Adjustment to head circumference...10 Functionality of the rechargeable LED battery...12

4.0 4.1 4.2 4.3

Operation...13 Different variants of the headlamp ATMOS HL 21 LED...13 Switching on...14 Focusing the headlamp...14

5.0 5.1

Cleaning and care...15 Recommended surface disinfectants...15

6.0 6.1

Maintenance and service...16 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

1.0 Introduction 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 headlamp ATMOS HL 21 LED safely, correctly, and effectively. - 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. • The quality management system used at ATMOS has been certified for quality management in accordance with the relevant international standards. • Reproduction of these operating instructions-even in part-only with the written permission of ATMOS.

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1.0 Introduction 1.2 Explanation of pictures and symbols In the operating instructions Abbreviations / symbols in these operating instructions: • Identifies a list - 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

SN

Serial number

Warning, pay special attention

IPX0

Specification of the degree of protection against the ingress of solids and moisture

This device complies with the relevant requirements of EU regulations.

Type B applied part

This device complies with the relevant requirements of the Eurasian Economic Union.

Professional disposal Recyclable

Manufacturer

Do not look directly into the light source

Date of manufacture

DE

4

Connection for lamp to rechargeable LED battery

Date of manufacture Country of manufacture: Germany

REF

Reference number

UDI

Unique Device Identifier of a medical device

MD

Medical device

Connection for charging power pack with polarity marking Test button for battery test

ECO

Half performance

1.0 Introduction

O

Lamp is switched off

POWER

Full performance Handle with care Fragile, handle with care Keep dry Keep away from sunlight Temperature limit Humidity limitation

1060

Atmospheric pressure limitation 700

UDI application identifier

(01)

UDI-DI: Identification of the manufacturer and the device

(11)

Date of manufacture

(21)

Serial number

5

1.0 Introduction 1.3 Intended purpose

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Product name:

ATMOS HL 21 LED

Main functions:

Medical LED cold light source with headband for fixation on the head of examiner

Intended purpose:

Illumination of orifices (e.g. ear/nose/throat) for visual diagnostics

Intended Users / User profile:

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/specific microbial status:

Non sterile

Single use product / reprocessing:

No single use product. Reprocessing according to instructions for use.

1.0 Introduction 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. The device is an electrical product. It contains an LED whose luminous flux is focused 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 1 1 1 1 1 HL 21 LED Charging power 1 1 pack (Euro/UK/US/ Aus) 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.

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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! • During each application, pay attention to proper fit of the headlamp ATMOS HL 21 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 quickly when the battery goes flat. • If the headlamp ATMOS HL 21 LED is used by several users, regular cleaning and disinfection must be carried out. • Switch off the headlamp ATMOS HL 21 LED when not in use. • Report all serious incidents that have occurred in connection with this product to the manufacturer and your national competent authority.

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3.0 Setting up and starting up 





 

Fig. 1a + 1b. Individual components

  3.1 Individual components of the headlamp 1 2 3 4 5 6 7

Headlamp ATMOS HL 21 LED Different power plugs for charging power pack (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

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3.0 Setting up and starting up 





Fig. 2. Headlamp ATMOS HL 21 LED 1 Headlamp frame 2 Turning knob for adjusting the circumference 3 Strap for adjusting the height Prior to first operation, pay attention to the safety information in chapter 2.0. Prior to using the headlamp for the first time, charge the LED battery by means of the 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 comfortable and correct fit by means of the turning knob ( 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.

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3.0 Setting up and starting up 





Fig. 3. 4 Cable holder 5 Cable clip 6 Front pad 7 Headlamp connection



Fig. 4.

Connection of LED light battery

• Take one of the enclosed connecting cables and join it to the ATMOS HL 21 LED headlamp connection ( 7 , Fig. 3). • Use the short connecting cable if you want to carry the LED battery on the headband (Fig. 8, page 13). • Use the long connecting cable if you want to carry the LED battery in your coat pocket, in your trouser pocket, or on your belt. This cable is also to be used if the headlamp is to be supplied from an ATMOS power source. If necessary, lead the cable under the front pad and through the cable holders in the joint of the headlamp ATMOS HL 21 LED. • Use the enclosed cable clip ( 5 , Fig. 3) to fix the long cable to your clothes. • Join the other end of the connecting cable with the socket on the rechargeable LED battery (Fig. 4) or with the power source in your ATMOS ENT treatment unit. • Note: By means of its rear cable clip, the rechargeable LED battery can be fixed to your coat pocket, to your belt, or to the battery holder on the headlamp ATMOS HL 21 LED.

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3.0 Setting up and starting up 



  Fig. 5. 1 Test button 2 Indication of the battery capacity (green LED)

Fig. 6. 1 Connecting socket for headlamp 2 Charging socket on LED battery

3.3 Functionality of the rechargeable LED battery 3.3.1 Capacity indication Charging of the LED battery must be checked regularly, as the light goes out very quickly when the battery goes flat. We recommend changing or charging the battery when the capacity is <50%. • As long as the test button ( 1 , Fig. 5) of the rechargeable LED battery is pressed, the battery capacity is shown for approx. 3 seconds ( 2 , Fig. 5, green LEDs for levels 1...5).

3.3.2 Charging the LED battery • Use the primary adapter fitting your power supply (Euro/US/UK/Aus). See information enclosed with the charging power pack. • To charge the LED battery, disconnect it from the headlamp ATMOS HL 21 LED. • Join the round connector of the power pack cable with the socket ( 2 , Fig. 6) on the LED battery. • During the charging process, the current battery capacity is indicated ( 2 , Fig. 5, green LEDs for levels 1...5). The battery is fully charged when all 5 LEDs go out again. During charging, operation of the headlamp is impossible!

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4.0 Operation

Fig. 7.

Headlamp without battery holder

Fig. 8.

Headlamp with battery holder

4.1 Different variants of the headlamp ATMOS HL 21 LED • Fig. 7: Headlamp ATMOS HL 21 LED with long cable, supply from the LED battery in the coat pocket or from a suitable ATMOS power source in an ENT treatment unit. Also pay attention to the respective operating instructions of the ATMOS ENT treatment unit. • Fig. 8: Headlamp ATMOS HL 21 LED with short cable, LED battery in battery holder on the headlamp. • For removing the battery holder, proceed as follows: - Use the turning knob to adjust the headlamp frame quite tight. - Remove the center cover in the turning knob and then take a Phillips-head screwdriver to remove the screw. - Remove the turning knob and remove the battery holder. - Add the turning knob again. Make sure that the tight adjustment of the headlamp frame has not changed. Otherwise, the headlamp frame must be pushed together again. - Insert screw and replace the cover cap.

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4.0 Operation 



Fig. 9. Focusing 1 Headlamp frame 2 Focusing ring

4.2 Switching on • Adjust the lateral switch on the LED battery to the desired position: - ECO mode: operation for approx. 4 hours. - POWER mode: operation for approx. 2 hours.

4.3 Focusing the headlamp • The size of the light spot can be adjusted by turning the focusing ring ( 2 , Fig. 9).

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5.0 Cleaning and care The measures described for cleaning and disinfection are not intended to replace the regulations applicable for the respective operation! Always comply on principle with the relevant manufacturer’s information regarding concentration and material compatibility. Do not use any: • disinfectants containing concentrated organic or inorganic acids or bases since these may cause corrosion damage. • disinfectants containing chloramines, phenol derivatives, or anionic surfactants since these may cause stress cracks in the plastics used. If the headlamp ATMOS HL 21 LED is used by several users, regular cleaning and disinfection must be carried out. Do not touch the lens in the light object. • Fingerprints can be wiped down with a soft cloth. If necessary, you may use ethanol. • The surfaces can be cleaned with a moist cloth. If necessary, you may use ethanol. • The headlamp ATMOS HL 21 LED cannot be sterilized. • The light body and the rigid headlamp frame can be wiped down on the outside with a cloth moistened with a surface disinfectant (see chapter 5.1). • The front pad can be cleaned using a brush, clear water, and soap. If necessary, you may use a 70%-ethanol solution. The cleaning agent must not contain toluene. The front pad may also be washed in the washing machine at 30 °C. It may not be spin-dried or be put in the tumble dryer.

5.1 Recommended surface disinfectants Disinfectant Incidin® Plus

Ingredients Glucoprotamin

(Application concentrate)

non-ionic surfactants

Dismozon® pur

Solvents, complexing agents Magnesium monoperoxyphthalate hexahydrate

80 g Bode Chemie, Hamburg

Magnesium monoperoxyphthalate hexahydrate

95.8 g Bode Chemie, Hamburg

Alkyldimethylbenzylammonium chloride

< 1 g Metasys, Rum (Austria)

(Application concentrate) End of product 12/2014 Dismozon® plus (Application concentrate) Green & Clean SK (Application concentrate)

(in 100 g) Manufacturer 26.0 g Henkel, Düsseldorf

Dialkyl-dimethyl-ammonium chloride

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6.0 Maintenance and service • Prior to each application, check the device's functions and its proper condition. Damaged cables must be replaced immediately! • The headlamp ATMOS HL 21 LED is low-maintenance. However, the regulations and instructions applying to the respective field of application have to be observed. • 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 unaffected. • Please comply with the country-specific guidelines regarding regular testing, especially with regard to electrical safety. ATMOS recommends a test every 24 months. • For repair, this device can be returned to ATMOS. • 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 not been carried out by personnel 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. • Rechargeable batteries are wearing parts and therefore excluded from the general 2-year product liability!

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6.0 Maintenance and service 6.1 Sending in the device • Clean and disinfect the product and accessories according to the operating instructions. • Place any used accessories with the product. • Fill in form QD 434 “Delivery complaint / return shipment” and the corresponding Decontamination certificate. ) This form is enclosed with each delivery and can be found at www.atmosmed.com . • The product must be well padded and packed in suitable packaging. • Place form QD 434 “Delivery complaint / return shipment” and the respective Decontamination certificate in an envelope. • Affix the envelope to the outside of the package. • Send the product to ATMOS or your dealer.

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7.0 Troubleshooting The ATMOS HL 21 LED was subjected to a thorough quality control in the factory. If, however, a problem should occur, you may solve it yourself if you follow these notes. Error symptom No light

LED battery cannot be charged

Cause of error LED battery is flat Cable is not connected properly Cable is defective LED battery is defective Charging power pack is defective

Remedy Charge LED battery Connect cable New cable New battery New charging power pack

8.0 Accessories Description...REF Lithium-ionic battery...507.4510.0

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9.0 Technical data Mains voltage

Current consumption: Power consumption: Illuminance: Life-span LED Light emitter: Rechargeable battery

Power cycle

Environmental conditions: Transport/Storage • Temperature range • Air humidity without condensation • Air pressure Environmental conditions: Operation: • Temperature range • Air humidity without condensation • Air pressure Maximum operating altitude Contamination level Overvoltage category

Charging power pack: 100–240 V~ 50/60 HZ; secondary 12 V DC Rechargeable battery: Charging with 12 V DC, lithiumionic battery with 3,7 V nominal voltage and a 1950 mAh capacity Charging power pack: 0,8 A via non-medical 1,8 m cable with DC plug 5,5 x 2,5 mm Light emitter: 2 watt 100.000 Lux Max 50.000 h White high-performance LED, Type 5500 K, light spot focusing with a diameter of 25 to 55 mm in 25 cm distance to the eye approx. 120 Min charging time after complete discharge; automatic switchover battery to compensation; capacity indication by 5 LEDs at the touch of a button and during the charging process, at least 500 charging cycles possible Rechargeable battery: switch with 2 operating modes (Power and ECO): 120 min operation with full light performance and at least 240 min with reduced light performance

−30...+50°C 5...90 % 700...1060 hPa

+10...35°C 20...80 % 700...1060 hPa 3000 m (NN) Class 2 I

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9.0 Technical data Dimensions (H x W x D)

Weight: Periodical tests: Protection class against electric shock (acc to EN 60601-1) Degree of protection against electric shock Degree of protection against Ingress CE mark Ident-No. (REF)

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Heading rack: Head measurement adjustable from 50–64 cm, level 92–115 mm Connecting cable: 40 cm, 140 cm and 200 cm long With emitter: approx. 200g Recommended: Check every 24 months / 2 years. II (Charging power pack) Applied parts type B IP X0

530.4020.0 ATMOS HL 21 LED 506.7551.0 ATMOS HL 21 LED 507.4505.0 ATMOS HL 21 LED (examination set) 507.4506.0 ATMOS HL 21 LED (OT set) 507.4500.0 ATMOS HL 21 LED