Atmos HL 21, Operating Instructions Manual

Page 1: ...Please store this document near the device for later use GA1GB 150303 0 2021 11 Index 10 ATMOS HL 21 LED MedizinTechnik Operating Instructions English ...

Page 2: ...al components of the headlamp 9 3 2 Adjustment to head circumference 10 3 3 Functionality of the rechargeable LED battery 12 4 0 Operation 13 4 1 Different variants of the headlamp ATMOS HL 21 LED 13 4 2 Switching on 14 4 3 Focusing the headlamp 14 5 0 Cleaning and care 15 5 1 Recommended surface disinfectants 15 6 0 Maintenance and service 16 6 1 Sending in the device 17 7 0 Troubleshooting 18 8 ...

Page 3: ...tial 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 H...

Page 4: ...ice complies with the relevant requirements of the Eurasian Economic Union Manufacturer Date of manufacture DE Date of manufacture Country of manufacture Germany REF Reference number UDI Unique Device Identifier of a medical device MD Medical device 1 0 Introduction SN Serial number IPX0 Specification of the degree of protection against the ingress of solids and moisture Type B applied part Profes...

Page 5: ...with care Fragile handle with care Keep dry Keep away from sunlight Temperature limit Humidity limitation 700 1060 Atmospheric pressure limitation UDI application identifier 01 UDI DI Identification of the manufacturer and the device 11 Date of manufacture 21 Serial number ...

Page 6: ...gnosed 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 con...

Page 7: ... 0 Headlamp ATMOS HL 21 LED 1 1 1 1 1 Charging power pack Euro UK US Aus 1 1 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 immediatel...

Page 8: ...S 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 t...

Page 9: ...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 1 2 3 4 5 6 7 Fig 1a 1b Individual components 3 0 Setting up and starting up ...

Page 10: ...d 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 lo...

Page 11: ...his 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 powe...

Page 12: ...e 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 fu...

Page 13: ...y 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 no...

Page 14: ...n 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 4 0 Operation ...

Page 15: ... 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...

Page 16: ...ly 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 origin...

Page 17: ...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 6 0 Ma...

Page 18: ...If however a problem should occur you may solve it yourself if you follow these notes Error symptom Cause of error Remedy No light LED battery is flat 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 battery New charging power pack ...

Page 19: ...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 Power cycle 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 Environmental co...

Page 20: ... Recommended Check every 24 months 2 years Protection class against electric shock acc to EN 60601 1 II Charging power pack Degree of protection against electric shock Applied parts type B Degree of protection against Ingress IP X0 CE mark Ident No REF 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...

Page 21: ...tain any hazardous goods The LED battery lithium ion must be disposed of correctly Prior to disposal device and accessories must be decontaminated Make sure that materials are separated carefully Pay attention to country specific regulations regarding disposal ...

Page 22: ...hielded room of a magnetic resonance imaging system The customer or user of the ATMOS HL 21 LED must ensure that it is used in a prescribed environment Guidance and manufacturer s declaration key features Please note the Technical Data in these instructions The essential features are fully usable even in the presence of electromagnetic disturbances Guidance and manufacturer s declaration removable...

Page 23: ...r Otherwise degradation of the performance of this equipment could result The distance may be reduced at higher immunity test levels WARNING Avoid placing the device on top of or next to another device This could result in faulty operation If such placement cannot be avoided the proper functioning of the device must be monitored regularly If possible please switch off any nearby devices that are n...

Page 24: ...ATMOS MedizinTechnik GmbH Co KG Ludwig Kegel Str 16 79853 Lenzkirch Germany Phone 49 7653 689 0 info atmosmed com www atmosmed com ...