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1.2 Intended purpose

Product name:

ATMOS i View 21
ATMOS i View 31

Main functions:

The device is a microscope intended to give a magnified illuminated spacial

view on human tissue for diagnostic and treatment purposes.

Intended purpose:

Standard ENT examination and treatment of ear, nose and throat

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:

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:

Standard ENT examination and / or therapy

Medical contra-indications:

None

Other contra-indications:

None

Warnings:

None

The product is:

active

Sterility/specific microbial status:

Not steril

Single use product / reprocessing:

Not a single use product. Reprocessing according to instructions for use.

1.0 Introduction

Содержание i View 21

Страница 1: ...ATMOS i View GA1GB 120101 0 2022 08 Index 26 Operating Instructions English ...

Страница 2: ... 3 2 3 Operating elements on the microscope 11 3 2 4 Rear view of the control device of the ATMOS i View 21 11 3 2 5 Rear view of the control device of the ATMOS i View 31 not with an integrated HD camera 11 3 2 6 Rear view of the control device of the ATMOS i View 31 with an integrated HD camera 12 3 3 Integration options 12 3 4 Starting up 13 3 5 Operating requirements 13 3 6 Starting up at a gl...

Страница 3: ...ur ATMOS i View will be preserved This device bears the CE marking CE in accordance with the European Medical Device Regulation MDR 2017 745 The product ATMOS i View complies with all applicable requirements of Directive 2011 65 EU restrict ing the use of certain hazardous substances in electrical and electronic equipment RoHS The Declarations of Conformity and our General Terms and Conditions can...

Страница 4: ...dical conditions to be diagnosed treated or monitored Diagnostic examination of anatomy of all kinds Application organ 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 Standard ENT examination and or therapy Medical contra indications None Other ...

Страница 5: ...ually switching the LED light source on and off despite the activated automatic light control Due to the variety of options the ATMOS i View has to offer the user is in a position to configure a microscope to suit his or her requirements The following functions can be chosen optionally 4 lenses with different fixed focal distances 200 250 300 and 400 mm with or without fine focusing or a VarioFocu...

Страница 6: ...rating instructions blue Weight adjustment for the carrier arm Professional disposal Alternating current Fuse 2 Do not reuse Exchange after use This device complies with the relevant require ments of EU regulations Do not look directly into the light source of the ATMOS i View UL Listing Mark This device complies with the relevant require ments of the Eurasian Economic Union MD Medical device UDI ...

Страница 7: ...th an integrated HD camera Sensor Strobo Extern 2 PC USB Video In Record Freeze Foot Switch Out 1 Out 2 Out 3 Video Out Microscope Intern 1 Video In 2 x T 3 15A 100 240V Output video signal only with an integrated HD camera 1 5 Scope of supply Prior to dispatch the ATMOS i View was subjected to an extensive functional test and was carefully packed Neverthe less please compare the contents of the s...

Страница 8: ...e control device The ATMOS i View is a device designed in line with IEC 60601 1 EN 60601 1 and is a protection class I device In order to avoid the RISK of electrical shock this device may only be connected to a power supply with a properly installed earth conductor Power cables accessories and access cables need to be checked for defects prior to starting up the ATMOS i View Damaged cables must b...

Страница 9: ... stereo effect Measuring scale Optional Optional Integrated control panel Optional Optional Color filter Optional Optional Integrated camera Optional HD camera HD adapter for an external camera Optional Endoscope adapter Optional Mains voltage 100 240 V 100 240 V Light output min 120 klx 200 mm min 80 klx 250 mm min 55 klx 300 mm min 30 klx 400 mm min 120 klx 200 mm min 80 klx 250 mm min 55 klx 30...

Страница 10: ...e removed from the IEC connector of the control de vice Potential equalization The ATMOS i View s supply module has a rear connection for potential equalization which can be connected to the potential equali zation rail in the room if need be Hereby user patient safety can be increased especially in the case of a defective earth conductor For connecting the device s potential equalization plug wit...

Страница 11: ...record ing function Output signal of the Freeze frame function Output signals of the tilt sensor in the carrier arm system Output for the triggering signal from the ATMOS Strobo 21 LED S video outputs of the integrated SD camera Connection for the supply to the micro scope electronics and control line Connection to the foot switch for switching between the light channels Connection for potential e...

Страница 12: ...ounting plate and pipe system on the ceiling The structural requirements must be met The ceiling mount is suitable for accommodating the ATMOS i View and a monitor up to 10 5 kg Only the supply module of the ATMOS i View and the monitor may be connected to the power supply outlets of the ceiling mount Risk of injury Do not put any additional weight on the ceiling mount Do not lean against the carr...

Страница 13: ...ould result in damage to biological tissue Please keep the luminosity and duration of use to a minimum Switch off the light source when not in use and check the heat development if necessary 3 0 Setting up and starting up 3 4 Starting up Check whether the voltage values on the type plate correspond to the line voltage provided Check the scope of delivery Peruse the safety information in part 2 0 p...

Страница 14: ... glasses on push eyepieces in direction of the lens tube until they engage audibly Adjust diopter scale to zero Remove glasses and adjust diopter scale to matching number eyepieces are pulled out Remove glasses and adjust both eyepieces to 5 dpt Remove the lens tube from the microscope head and focus on an object in the distance The object still looks blurred Turn the diop ter ring of the first ey...

Страница 15: ...the suspension prior to every use 4 2 Mechanical arm The mechanical microscope arm can be adjusted via four set screws according to the individual requirements of the user Choose the strength of the clamping so that the free movement of the arm suits your requirements Turn the set screw in clockwise direction to fixate the arm To loosen the arm turn the set screw counterclockwise To align the arm ...

Страница 16: ...opter ring to zero People with defective vision with known refraction val ues should take their glasses off and adjust the diopter scale on the eyepieces to the matching number the eye cups of the eyepieces are pulled out The process of focusing is performed as described in chapter 4 10 People with defective vision without glasses with un known refraction values adjust both eyepieces to 5 dpt Remo...

Страница 17: ...etting dial The setting dial can be positioned on either side of the VarioFocus lens Attention During the process firmly hold the VarioFocus lens just in case it may loosen itself from the microscope head and fall off Loosen the three grub screws on the lens Continue to hold the lens and turn the setting dial in the desired position Tighten the three grub screws 4 9 Adjusting the 5 fold magnificat...

Страница 18: ...inocular tube The tube s focal distance of 160 mm allows for more comfortable and fatigue free observation of the object with both eyes Working is made easier due to the exceptional ly large exit pupil and an increased stereo base of 24 mm Please hold the lens tube with one hand while loosening the screw Otherwise the lens tube could drop Loosen the screw on top of the binocular tube and remove th...

Страница 19: ...eneath the lens a true to scale dimension scale can be faded into the field of the illumination light path This documentation display enables the measurement of objects regardless of the selected magnification The scale will be displayed in both the 3D picture and on all camera pictures and if required it can be faded out at any time To fade in the scale turn the knob 45 in clockwise direction Via...

Страница 20: ...age Start stop the recording of a video frequency Adjust the light mode of the integrated HD camera The data are transmitted to a connected PC USB interface The ATMOSoft software can process the data Only with an integrated HD camera You can change between the integrated HD camera and external video sources by switching the LED light on or off As soon as the LED light goes off the integrated camer...

Страница 21: ...an external digital camera a special adapter which is suitable for the respective digital cam era is required 4 18 HD adapter Via the specially developed HD adapter it is possible to connect a SONY digital camera with e mount bayonet to the ATMOS i View This camera enables you to take and archive HD resolution pictures At dispatch the HD adapter is covered with a cover cap This cap protects agains...

Страница 22: ...epieces lenses results in optimum image quality Image quality could be reduced even by the slightest contamination of the optics or by fingerprints In order to protect the inter nal optics from dust the microscope should never be left without a safety cover HD adapter lens binocular tube or eyepieces installed when it is not in use After use the microscope should be covered in order to protect it ...

Страница 23: ... as they could cause stress cracks in the material used for the hous ing Disinfectant Suitable for Microscope Handle Control unit Other mechanical surfaces Optical surfaces Green Clean SK x x Bacillol 30 Foam x Kohrsolin FF Application concentrate x x x Kohrsolin extra Application concentrate x x x Mikrobac forte Application concentrate x x x Mikrozid sensitive wipes x x SaniCloth Active x x 5 5 H...

Страница 24: ...ssembly new settings alterations extensions and repairs have not been carried out by personnel author ized by ATMOS There are no warranty claims whatsoever on defects or malfunctions that arise from the use of third party acces sories or consumables The instructions and regulations for the respective field of application should be observed 6 2 Sending in the device Remove and properly dispose of a...

Страница 25: ...er is defective Contact ATMOS Service Arm follows Tie bar is not adjusted vertically The coverings of the set screws are worn out or not fixed in place Adjust tie bar Exchange or fix the coverings Too little or no light at all The ATMOS i View was moved into parking position and thereby the light was switched off Pull ATMOS i View into working position Malfunction of the LED light source Contact A...

Страница 26: ...us lens 200 500 mm 538 4500 0 Splash protection 538 3700 0 Lens tube REF Binocular straight tube 10 times 538 3900 0 Binocular straight tube 16 times 605 2000 0 45 adaption binocular tubes 606 1106 0 Binocular swivel tube i View PRO 538 9200 0 Cable only for the ATMOS i View 31 REF Cable HDMI type A C L 5 m only with an integrated HD cam era 538 1902 0 Cable HDMI extension L 5 m only with an integ...

Страница 27: ...a Environmental conditions Operation Temperature range 10 35 C Air humidity without condensation 30 95 Air pressure 700 1060 hPa Maximum operating altitude 3000 m Contamination level 2 Overvoltage category II Weight 3 65 5 6 kg Periodical tests Repeat test of the electrical safety every 24 months Protection class against electric shock acc to EN 60601 1 Recommended inspection according to the manu...

Страница 28: ...ing national laws and rules for disposal of old devices in the respective country Disposal within the Federal Republic of Germany In the Federal Republic of Germany the law for electrical devices ElektroG regulates the disposal of electrical devices It must be assumed that these devices could be contaminated Therefore according to the regulations of the EAR foundation Used Electrical Appliances Re...

Страница 29: ...ven in the presence of electro magnetic disturbances Guidance and manufacturer s declaration removable components that can be replaced by the operator The ATMOS i View has the following removable components that can be replaced by the operator Type REF Max cable length Power cable 507 0859 0 3 0 m Guidance and manufacturer s declaration warnings WARNING The use of electrical components and accesso...

Страница 30: ...30 12 0 Notes ...

Страница 31: ...31 12 0 Notes ...

Страница 32: ...ATMOS MedizinTechnik GmbH Co KG Ludwig Kegel Str 16 79853 Lenzkirch Germany Phone 49 7653 689 0 info atmosmed com www atmosmed com ...

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