ATMOS HL 21 LED. Gebrauchsanweisung. Operating Instructions. English. MedizinTechnik. Please store this document near the device for later use!

Transcription

1 MedizinTechnik English ATMOS HL 21 LED Gebrauchsanweisung Operating Instructions B B B B B B B Index: 09 Please store this document near the device for later use!

2 Table of contents 1.0 Introduction Notes on operating instructions Explanation of symbols Notes on safety Intended use Setting up and starting up Individual components of the headlight Adjustment to head measurement Functionality of rechargeable LED battery Operation Variants of the headlight ATMOS HL 21 LED Switching on Focusing the headlight ATMOS HL 21 LED Notes on cleaning and care Recommended surface disinfectants Maintenance and servicing Trouble-shooting Accessories, spare parts, consumables Technical specifications Disposal Notes on Electromagnetic Compatibility (EMC)...18 ATMOS MedizinTechnik GmbH & Co. KG Ludwig-Kegel-Str Lenzkirch / Germany Phone: Fax: (Sales National) Fax: (Export) atmos@atmosmed.de 2

3 1.0 Introduction 1.1 Notes on operating instructions These operating instructions are valid for following devices: ATMOS HL 21 LED REF Examination set ATMOS HL 21 LED REF OT set ATMOS HL 21 LED REF Unit set in connection with the accessories mentioned in chapter 9.0. These operating instructions contain important information on how to operate the ATMOS HL 21 LED safely, correctly and effi ciently. ALWAYS STORE 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 care and maintenance of the 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 authorised by ATMOS. Only original spare parts may be used for repairs. This will guarantee that the safety, readiness for operation and value of your device will be maintained. The ATMOS HL 21 LED bears the CE identifi cation symbol CE in accordance with the EU Medical Devices Directive (MDD) - Directive 93/42/EEC and meets the basic requirements of Annex I to this Directive. The product ATMOS HL 21 LED complies with all applicable requirements of the directive 2011/65/EC 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 The quality management system used at ATMOS has been certifi ed for quality management in accordance with the relevant international standards. These operating instructions correspond to the design of the device and the status of basic safety engineering standards on going to press. Reproduction of these instructions - even in part - only with the written permission of ATMOS. Abbreviations / symbols in these operating instructions: Identifi es a list Subdivision of a list/activity. The recommended sequence must be adhered to in each case! Important notes! 3

4 1.0 Introduction 1.2 Explanation of symbols The following symbols are on the ATMOS HL 21 LED, on the rechargeable LED battery or on the charging power pack. Please remember their meaning. Symbol "Pay attention to operating instructions". This symbol shall draw your attention to the safety information contained in the operating instructions. It serves as a reference to particular notes which are important for the application of the headlight. The CE identifi cation symbol shows that this device complies with the appropriate requirements of the EU guidelines. Protective insulation, class II equipment Type B device SN Serial number REF Order number ECO Half performance O Lamp switched off POWER Full performance Test button for battery test Connection for lamp to rechargeable LED battery Connection for charging power pack with identifi cation of the polarity 4

5 2.0 Notes on safety Prior to starting up the headlight ATMOS HL 21 LED, read these operating instructions carefully. ATMOS cannot guarantee perfect functioning neither will it be 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, resetting, alterations, extensions and repairs are not carried out by people authorised 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 EMC area described in the Annex. Only use the charging power pack supplied by ATMOS. Exclusively use the headlight ATMOS HL 21 LED in connection with the rechargeable ATMOS LED battery or ATMOS current sources. Separation of the charging power pack from the supply is only guaranteed with the charging power pack being disconnected 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 fi t of the headlight ATMOS HL 21 LED. Note: The headlight ATMOS HL 21 LED is not sterile! This fact might be important for medical operations. Always make sure that you do not shine in patient's eyes resp. that the patient does not look directly into the light exit as, otherwise, EYE INJURIES MIGHT BE THE CONSEQUENCE. Charging of the LED battery must be checked regularly as the light expires very fast when the battery gets fl at. When the headlight ATMOS HL 21 LED is applied by several users, regular cleaning and disinfection is necessary. When not in use, switch off the headlight ATMOS HL 21 LED. 5

6 3.0 Intended use Name: Main functions: ATMOS HL 21 LED Headlight for medical examination: Illumination of orifi ces for the examination in the ENT field. OT-headlight: Illumination of the operating fi eld, natural body orifi ces. Med. indications/ application: Illumination of body orifi ces. Specification of the main function: Due to the long-life light source with power-white light LED (service life approx h) in combination with a high-end-battery system the ATMOS HL 21 LED enables a homogenous illumination of the examination resp. operating fi eld. Application organ: Application time: Application site: Contraindications: Ear, nose, throat Headlight for medical examination: Temporary application the operation and application of the headlight may only be performed by trained staff. OT-headlight: For short-term application (max. 4 hours) the operation and application of the headlight may only be performed by trained staff. Headlight for medical examination: Application environment are ENT clinics and practices. OT-headlight: Application environment are operating rooms. None The product is: X active not active Sterility: Not necessary Single use product / reprocessing: No single use product 6

7 4.0 Setting up and starting up Fig. 1a + 1b. Single components 4.1 Individual components of the headlight Headlight ATMOS HL 21 LED Different mains plugs for charging power pack (Euro/UK/US/Aus) Charging power pack 12 V DC Rechargeable LED battery Connecting cable; length: 40 cm, 140 cm and 200 cm Cable holder on headlight rack Adjusting instruments on the headlight rack. 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 following extent of supply). Please document and report damages in transit immediately. For complaints or return deliveries, please use enclosed form QD 434. Extent of supply Extent of supply Extent of supply of Examination Set of OT Set of Unit Set REF REF REF Headlight 1 Headlight 1 Headlight ATMOS HL 21 LED ATMOS HL 21 LED ATMOS HL 21 LED 1 Charging power pack 1 Charging power pack 1 Cable 200 cm (Euro/UK/US/Aus) (Euro/UK/US/Aus) 1 Cable clip 1 Rechargeable LED batteries 2 Rechargeable LED batteries 1 Cable 40 cm 1 Cable 40 cm 1 Battery holder 1 Cable 140 cm 1 Cable clip 1 Battery holder 7

8 4.0 Setting up and starting up Fig. 2. Headlight ATMOS HL 21 LED Headlight rack Turning knob for adjusting the measurement Strap for adjusting the level Prior to fi rst operation, pay attention to the safety information in chapter 2.0. Prior to fi rst use of the headlight, charge the LED battery by means of the supplied charging power pack. 4.2 Adjustment to head measurement At first, take the headlight rack incl. headlight (, fig. 2) and put it on a table in front of you. Adjusting the headlight rack: Depending on your head measurement, adjust the headlight rack gradually to a comfortable and correct position by means of the turning knob (, fig. 2). The level of the headlight rack is adjusted by means of a strap (, fig. 2). The lower edge of the headlight rack is to be positioned directly above the ears. 8

9 4.0 Setting up and starting up Fig. 3. Cable holder Cable clip Front pad headlight connection Fig. 4. Connection of LED battery 4.2 Adjustment to head measurement (contin.) Take one of the enclosed connecting cables and join it with the headlight connection (, fig. 3). Use the short connecting cable if you want to carry the LED battery on the headband. (fi g. 8, page 11). 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 headlight is to be supplied from an ATMOS current source. If necessary, lead the cable under the front pad and through the cable holders in the joint of the headlight ATMOS HL 21 LED. Use the enclosed cable clip (, fi g. 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 current source in your ATMOS ENT examination unit. Note: By means of its rear cable clip, the rechargeable LED battery can be fi xed to your coat pocket, to your belt or to the battery holder on the headlight ATMOS HL 21 LED. 9

10 4.0 Setting up and starting up Fig. 5. Test button Indication of battery capacity (green LED) Fig. 6. Connecting socket for headlight Charging socket on LED battery 4.3 Functionality of the rechargeable LED battery Capacity indication Charging of the LED battery must be checked regularly as the light expires very fast when the battery gets fl at. We recommend to change resp. charge the battery when the capacity is <50%. As long as the test button (, fi g. 5) of the rechargeable LED battery is pressed, the battery capacity is shown for about 3 seconds (, fig. 5, green LEDs for levels ) Charging the LED battery Use the primary adapter fi tting for your power supply (Euro/US/ UK/Aus). See information enclosed to the charging power pack. To charge the LED battery, separate it from the headlight ATMOS HL 21 LED. Join round connector of the power pack cable with the socket (, fig. 6) on the LED battery. During the charging process, the current battery capacity is indicated (, fig. 5, LEDs for levels ). The battery is fully charged when all 5 LEDs expire again. During charging, operation of the headlight is impossible! 10

11 5.0 Operation Fig. 7. Headlight without battery holder Fig. 8. Headlight with battery holder 5.1 Different variants of the headlight ATMOS HL 21 LED Fig. 7: Headlight ATMOS HL 21 LED with long cable, supply from the LED battery in the coat pocket or from a suitable ATMOS current source in an ENT examination unit. Also pay attention to the respective operating instructions of the ATMOS ENT examination unit. Fig. 8: Headlight ATMOS HL 21 LED with short cable, LED battery in battery holder on the headlight. For removing the battery holder, proceed as follows: Use the turning knob to adjust the headlight rack quite tight. Remove the centric cover in the turning knob and then take a Philips head screwdriver to remove the screw. Remove the turning knob. Remove the battery holder. Add the turning knob again. Make sure that the tight adjustment of the headlight rack has not changed. Otherwise, the headlight rack is to be pushed together again. Add screw and cover again. 11

12 5.0 Operation Fig. 9. Focusing Headlight rack Focusing ring 5.2 Switching on Adjust the lateral switch on the LED battery to the desired position: ECO mode: operation for about 4 hours. POWER mode: operation for about 2 hours. 5.3 Focusing the headlight The size of the light spot can be adjusted by turning the focusing ring (, fig. 9). 12

13 6.0 Cleaning 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 organic or inorganic acids or bases since these may cause corrosion damage. Disinfectants containing chloramines, phenol derivatives or anionic tensides since these may cause stress cracks in the plastics used. When the headlight ATMOS HL 21 LED is applied by several users, regular cleaning and disinfection is necessary. 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 headlight ATMOS HL 21 LED cannot be sterilised. The light body and the rigid headlight rack can be wiped down with a cloth moistened with a surface disinfectant (see page 14). 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 tuluol. The front pad may also be cleaned in the washing machine (30 ). Nevertheless, it may not be spin-dried or be put in the tumbledrier. 6.1 Recommended surface disinfectants Disinfectant Ingredients (in 100 g) Manufacturer Incidin Plus Glucoprotamin 26,0 g Henkel, Düsseldorf (Application concentrate) Nonionic tensides Solvents, complexing agents Dismozon pur magnesium monoperoxyphthalate 80 g Bode Chemie, Hamburg (Application concentrate) hexahydrate End of product 12/2014 Dismozon plus magnesium monoperoxyphthalate 95,8 g Bode Chemie, Hamburg (Application concentrate) hexahydrate Green & Clean SK alkyl-dimethyl-benzyl-ammonium (Application concentrate) chloride dialkyl-dimethyl-ammonium <1 g Metasys, Rum (Austria) chloride 13

14 7.0 Maintenance and servicing Prior to each application, check the device's functions and its proper condition. Damaged cables must be replaced immediately! The headlight ATMOS HL 21 is low-maintenance. However, the regulations and instructions applying to the respective fi eld of application have to be taken into account. Maintenance, repairs and period 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 specifi c guidelines regarding regular testing especially for the electrical safety. ATMOS recommends a test every 24 months. For repair, this device can be returned to ATMOS. Prior to effecting a return shipment, clean and disinfect the device. ATMOS cannot guarantee perfect functioning neither will it be 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, resetting, alterations, extensions and repairs are not carried out by people authorised 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 2 years product liability! 8.0 Trouble-shooting Prior to dispatch, the headlight ATMOS HL 21 LED was subjected to an extensive functional test. If, nevertheless, a failure should appear, you may possibly clear it yourself if you follow these notes: Symptom Cause Remedy No light LED battery is fl at Charge LED battery LED battery cannot be charged Cable is not correctly connected Cable is defective LED battery is defective Charging power pack is defective Connect cable New cable is required New LED battery is required New charging power pack is required 14

15 9.0 Accessories, spare parts, consumables 9.1 Accessories Description REF Connecting cable for LED battery, 40 cm Connecting cable for LED battery, 140 cm Connecting cable for LED battery, 200 cm Clip - for fixing the cable to clothes Spare parts Description REF Light body complete Headlight rack Universal battery quick-charging power pack with primary adapters assortment (Euro/UK/US/Aus) Cable holder Consumables Description REF Replacement LED battery (lithium-ionic) Front pad Nape pad

16 10.0 Technical Data Charging power pack V~ 50/60 Hz; exchangeable primary adapters (Euro/ UK/US/Aus); secondary 12 V DC; 0.8 A via non-medical 1.8 m cable with DC plug 5.5 x 2.5 mm; protection class II; only for dry rooms Rechargeable battery Charging with 12 V DC; approx. 120 min charging time after complete discharge; automatic switchover battery to compensation charging; capacity indication by 5 LEDs at the touch of a button and during the charging process; lithium-ionic battery with 3.7 V nominal voltage and a 1950 mah capacity; at least 500 charging cycles possible; switch with 2 operating modes (Power and ECO): 120 min operation with full light performance and at least 240 min with reduced light performance; weight approx. 80 g Light emitter White high-performance LED; Type 5500K; 2 watt; light spot focusing with a diameter of 25 to 55 mm in 25 cm distance to the eye Illuminance 100,000 Lux Life-span LED max. 50,000 h Headlight rack Head measurement adjustable from cm, level mm, weight with emitter: approx. 200 g Connecting cable 40 cm, 140 cm and 200 cm long Ambient conditions Transport/storage C, % humidity without condensing, air pressure hpa Operation C, % humidity without condensing, air pressure hpa Period tests Recommended: Testing every 24 months. Classifi cation acc. to Annex IX EEC I directions 93/42/EWG Protection class (EN ) II (charging power pack) Protection category IP X0 Degree of protection Device / application part: Type B CE identifi cation CE UMDNS-Code GMDN-Code Canadian Classifi cation Device group: PNC Risk Class Description Ophthalmology 86KAF 1 Issue of Technical Specifi cations:

17 11.0 Disposal The headlight ATMOS HL 21 LED does not contain any hazardous goods. The LED battery (lithium-ionic) must be disposed of correctly. Prior to disposal, device and accessories must be de-contaminated. Make sure that materials are separated carefully. Pay attention to country-specifi c regulations regarding the disposal. 17

18 12.0 Notes on EMC Medical electrical equipment is subject to special precautions with regard to EMC and must be installed acc. to following EMC notes. Portable and mobile HF communication facilities can infl uence medical electrical equipment. The use of other accessories, other converters and cables than stated may lead to an increased emission or a reduced interference immunity of the equipment or system. Guidelines and Manufacturer's Declaration - Emissions The headlight ATMOS HL 21 LED is intended for use in the electromagnetic environment specifi ed below. The customer or user of the ATMOS HL 21 LED should ensure that it is used in such an environment. Emissions Test Compliance Electromagnetic Environment - Guidance "RF Emissions CISPR 11" "RF Emissions CISPR 11" "Harmonics IEC " "Flicker IEC " Group 1 Class B Inapplicable Inapplicable The headlight ATMOS HL 21 LED uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. The headlight ATMOS HL 21 LED is suitable for use in all establishments, including domestic, and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. 18

19 12.0 Notes on EMC The device may not be used when being set up directly besides another equipment resp. when being stacked with other equipment. If, nevertheless, one of these arrangements is necessary, the device is to be observed to check its intended use. Guidelines and Manufacturer's Declaration - Immunity The headlight ATMOS HL 21 LED is intended for use in the electromagnetic environment specifi ed below. The customer or user of the ATMOS HL 21 LED should ensure that it is used in such an environment. Immunity Test IEC Test Level Compliance Level Electromagnetic Environment - Guidance "ESD IEC " "EFT IEC " "Surges IEC " ± 6 kv Contact ± 8 kv Air ± 2 kv Mains ± 1 kv l/os ± 1 kv Differential ± 2 kv Common ± 6 kv Contact ± 8 kv Air ± 2 kv for mains cables Inapplicable ± 1 kv symmetric Inapplicable Floors should be wood, concrete, or ceramic tile. If floors are synthetic, the relative humidity should be at least 30 %. Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. 19

20 12.0 Notes on EMC Guidelines and Manufacturer's Declaration - Immunity The headlight ATMOS HL 21 LED is intended for use in the electromagnetic environment specifi ed below. The customer or user of the ATMOS HL 21 LED should ensure that it is used in such an environment. Immunity Test IEC Test Level Compliance Level Electromagnetic Environment - Guidance "Voltage Dips/ Dropout IEC " "Power Frequency 50/60 Hz Magnetic Field IEC " NOTE < 5 % U T (> 95 % Dip of the U T ) for 0.5 Cycle 40 % U T (60 % Dip of the U T ) for 5 Cycles 70% U T (30 % Dip of the U T ) for 25 Cycles < 5 % U T (>95 % Dip of the U T ) for 5 s < 5 % U T (> 95 % Dip of the U T ) for 0.5 Cycle 40 % U T (60 % Dip of the U T ) for 5 Cycles 70% U T (30 % Dip of the U T ) for 25 Cycles < 5 % U T (>95 % Dip of the U T ) for 5 s Mains power quality should be that of a typical commercial or hospital environment. If the user of the ATMOS HL 21 LED demands continued function even in case of interruptions of the energy supply, it is recommended to supply the ATMOS HL 21 LED from an uninterruptible current supply or a battery. 3 A/m Inapplicable Power frequency magnetic fi elds should be that of a typical commercial or hospital environment UT is the mains alternating current prior to application of the test levels. 20

21 12.0 Notes on EMC Guidelines and Manufacturer's Declaration - Immunity The headlight ATMOS HL 21 LED is intended for use in the electromagnetic environment specifi ed below. The customer or user of the ATMOS HL 21 LED should ensure that it is used in such an environment. Immunity Test IEC Test Level Compliance Level Electromagnetic Environment - Guidance Portable and mobile communications equipment should be separated from the ATMOS HL 21 LED incl. the cables by no less than the distances calculated/listed below. Conducted RF IEC Radiated RF IEC V eff 150 khz to 80 MHz 3 V/m 80 MHz to 2.5 GHz 10 V 10 V/m Recommended distances: D = 0,35 P D = 0,35 P D = 0,7 P where P is the max. power in watts (W) and D is the recommended separation distance in meters (m). Field strengths from fi xed transmitters, as determined by an electromagnetic sitea survey, should be less than the compliance level b. Interference may occur in the vicinity of equipment containing following symbol. 21

22 12.0 Notes on EMC Guidelines and Manufacturer's Declaration - Immunity The headlight ATMOS HL 21 LED is intended for use in the electromagnetic environment specifi ed below. The customer or user of the ATMOS HL 21 LED should ensure that it is used in such an environment. Immunity Test IEC Test Level Compliance Level Electromagnetic Environment - Guidance NOTE 1 With 80 MHz and 800 MHz the higher frequency range applies. NOTE 2 These guidelines may not be applicable in every case. The propagation of electromagnetic sizes is infl uenced by absorptions and refl ections of buildings, objects and people. a The fi eld strength of stationary transmitters, such as base stations of cellular phones and mobile terrain radio equipment, amateur radio transmitters, cbm broadcast and TV stations cannot be predestined exactly. To determine the electromagnetic environment in regard to stationary transmitters, a study of the location is to be considered. If the measured fi eld strength at the location where the ATMOS HL 21 LED is used exceeds the above compliance level, the ATMOS HL 21 LED is to be observed to verify the intended use. If abnormal performance characteristics are noted, additional measures might be necessary, e.g. a changed arrangement or another location for the ATMOS HL 21 LED. b Within the frequency range of 150 khz to 80 MHz the fi eld strength is to be below 10 V/m. 22

23 12.0 Notes on EMC Recommended separations between portable and mobile RF Communications equipment and the headlight ATMOS HL 21 LED The headlight ATMOS HL 21 LED is intended for use in electromagnetic environment in which ratiated disturbances are controlled. The customer or user of the ATMOS HL 21 LED can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF Communications equipment and the ATMOS HL 21 LED as recommended below, according to the maximum output power of the communications equipment. Nominal output of the transmitter Separation distance, depending on transmit-frequency m 150 khz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2,5 GHz W D = 0,35 P D = 0,35 P D = 0,7 P m m 0.07 m m 0.11 m 0.22 m m 0.35 m 0.70 m m 1.11 m 2.22 m m 3.5 m 7.0 m For transmitters for which the maximum nominal output isn't indicated in the above table, the recommended separation distance d in meters (m) can be determined using the equation belonging to the respective column whereas P is the maximum nominal output of the transmitter in watts (W) acc. to manufacturer's specifi cation. NOTE 1 With 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not be applicable in every case. The propagation of electromagnetic sizes is infl uenced by absorptions and refl ections of buildings, objects and people. 23

24 ATMOS MedizinTechnik GmbH & Co. KG Ludwig-Kegel-Str Lenzkirch / Germany Phone: atmos@atmosmed.de