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MedizinTechnik
ATMOS® i View DENT
538.8000.B539.8000.B
2014-08 Index: 03
Ope
rati
ng in
stru
ctio
ns
English
2
ATMOSMedizinTechnik GmbH & Co. KGLudwig-Kegel-Straße 1679853 LenzkirchGermany
Phone +49 7653 689-0Fax: +49 7653 689-190 +49 7653 689-292 (Service Center)
E-mail: [email protected]: www.atmosmed.de
5.0 Cleaning and Care ..........................................................20-215.1 Instructions for cleaning and care .........................................205.2 Cleaning the mechanical microscope surface .......................205.3 Cleaning of lenses / eyepieces .............................................215.3.1 Cleaning optical surfaces ......................................................215.3.2 Optical surface of the endoscope port ..................................215.3.3 Fogging of optical surfaces ...................................................215.4 Hygienic plan .........................................................................21
6.0 Maintenance and Service ...................................................226.1 General advice ......................................................................22
7.0 Troubleshooting ..................................................................23
8.0 Options and Accessories ...................................................24
9.0 Technical data......................................................................26
10.0 Disposal ...............................................................................27
11.0 Notes on EMC .................................................................28-30
ATMOS General terms and conditions
1.0 Introduction ........................................................................3-71.1 Notes on operating instructions................................................31.2 Intended use............................................................................41.3 Functions..................................................................................51.4 Explanation of pictures and symbols........................................61.5 Scope of supply........................................................................71.6 Transport and storage..............................................................7
2.0 For your safety ......................................................................8 3.0 Setting up and starting up ...............................................9-133.1 Overview DENT...................................................................... 93.2 Assembly ...............................................................................103.2.1 Connection to the mains supply ............................................103.2.2 Microscope DENT .................................................................103.2.3 Operating elements at the microscope ................................. 113.2.4 Rear overview of the control device ATMOS® i View 21 DENT ...................................................... 113.2.5 Rear view of the control device ATMOS® i View 31 DENT ...................................................... 113.3 Integration options .................................................................123.1 Mobile stand DENT ...............................................................123.2 Wall stand ..............................................................................123.4 Start up ..................................................................................123.5 Operating requirements ........................................................123.6 Starting up at a glance ..........................................................13
4.0 Operation ........................................................................14-194.1 Microscope suspension .........................................................144.2 Mechanical arm DENT ..........................................................144.3 Hand grips .............................................................................144.3.1 Lateral double hand grip .......................................................144.4 Adjusting the interocular distance .........................................154.5 Adjusting the eye pieces .......................................................154.6 Exchange of lenses ...............................................................164.7 Exchange of lenses with manual fi ne focusing .....................164.8 Adjustment of the 5 fold magnifi cation changer ....................164.9 Focussing ..............................................................................174.9.1 Fine focussing .......................................................................174.10 Exchange of lense tubes .......................................................174.11 Binocular rotary disk with detent ...........................................174.12 Pivoting colour fi lter ...............................................................184.13 Microscope zoom and object fi eld size .................................184.14 Measuring scale ....................................................................184.15 Integrated camera .................................................................194.16 Endoscope adapter ...............................................................194.17 HD adapter ............................................................................19
Table of contents
3
1.1 Notes on operating instructions
These operating instructions contain important notes on how to operate the ATMOS® i View DENT safely, correctly and effectively. Their reading helps to avoid risks, and also to reduce repair costs and down-times. This increases, amongst other things, the reliability and service-life of the device.These operating instructions serve not only for new operating personnel to be instructed in its use, but also for use as a reference manual. Reprints (also in extracts) only with permission in written form by ATMOS.These operating instructions must always be kept available near the device.
Care and safety inspections in conjunction with professional execution provide for operational safety and readiness for use of your ATMOS® i View DENT and are therefore a must besides regular cleaning. Repair work and safety inspections may be carried out only by expert personnel authorised by ATMOS. By applying only original spare parts you will have the guarantee that operational safety, readiness for work and the value of your ATMOS® i View DENT will be preserved.
The product ATMOS® i View DENT bears CE marking CE 0124 according to the EC Directive of the council for medical products 93/42/EEC and meets the basic requirements of Appendix I of the directive. The product ATMOS® i View DENT 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 can be obtained on our website at www.atmosmed.com. The quality management system applied at ATMOS has been certified according to international standards EN ISO 9001 and EN ISO 13485. Prior to start-up please peruse chapter 2.0 „For your safety“, in order to be prepared for any possible dangerous situations.
Please keep this document for future consultation!
These operating instructions are valid for the following devices:
ATMOS® View 21 DENT Set..............................REF 538.9000.0
ATMOS® View 31 DENT Set..............................REF 539.9000.0
1.0 Introduction
4
1.2 Intended useName: ATMOS® i View 21 DENT ATMOS® i View 31 DENT
Main functions: Optical instrument for magnifi cation and illumination from the mouth to the pharynx and the teeth including root canal. It can be used for observation and documentation as well as for the treatment of humans.
Med. indications/ application: Standard dental examination for visual inspection in the fi eld of endodontics, periodontology, oral surgery, implantology, prosthodontics, aesthetic dentistry, conservative dentistry, oral maxillofacial surgery
Specifi cation of the main function: The application organ is illuminated by an integrated, fanless high transmission high performance LED light source, 5-step magnifi cation changer (0,4 / 0,6 / 1,0 / 1,6 / 2,5), integrated camera modules, pivoting colour fi lters and an automatic light control via tilt sensor. The light output is min. 80 kLux (250 mm) and a colour temperature of 5.500 K ± 10%. The illuminated organ can be visualized on a monitor if desired.
Application organ: Oral cavity, teeth, periodontal apparatus, jaw, jaw bone, maxillary sinus
Application time: Short term use on the patient (up to 30 days)
Application site: Application sites are dental clinics, dental practices and dental ORs as well as oral and maxillofacial surgeons and dental laboratory. The examination with the microscope may only be executed by medically trained persons. The microscope may only be used in closed rooms, on the ground, on the wall or to the ceiling. In ORs an appropriate protective sleeve must be used for the microscope.
Contraindications: No application in ophthalmology.
The product is: X active not active
Sterility: The microscope is no sterile product.
Single use product / reprocessing: The microscope is intended for multiple use. The device and part of the accessories are reusable, for information on reprocessing and disinfection please see the operating instructions.
1.0 Introduction
5
1.3 FunctionsThe ATMOS® i View DENT is a complete microscope system, consisting of optics and lighting and patent registered optics. It produces outstanding pictures for examination purposes with the use of latest LED technology and patent registered optics. The interaction between the integrated fanless, high transmission, high performance LED, the apochromatic optics and the precisely fi tting options offer best working quality.The ergonomically assorted buttons, two selectable hand grips and the integrated operator panel gives the user the highest level of ergonomic comfort and suitability for daily use as well as an and outstanding and intuitive handling. Via the operator panel the individual options of the ATMOS® i View DENT can be activated. Besides the triggering of the camera (freeze frame) and starting / stopping of possible video sequences the operator is capable of manually switching the LED light source on and off despite the activated light control by use of a mode-button. Due to the variety of options whicht the ATMOS® i View DENT has to offer the user is in a position to confi gurate a microscope to suit his requirements. The following functions can be chosen optionally:
4 lenses with different focal distances (200, 250, 300 and 400 mm) with or without fi ne focus (easy exchange of lenses due to the respective thread on the microscope head) 5 fold magnifi cation changer, exact adjustments due to rotating disks on both sides. Binocular straight lens tube, binocular angled lens tube and binocular swivel tube simple adaption due to the dove tail. Pivoting colour fi lter Measuring scale
Due to the LED light source and the integratable camera solution (SD integrated, resp. as HD- or as an endoscope adapter for the connection of an external camera) the ATMOS® i View DENT is a guarantor for best image quality.
In connection with the mechanical support arm and the numerous connection possibilities to units and stands the ATMOS® i View DENT offers countless system possibilities, which can be individually adapted to suit the users environment.
Dental Due to the dental microscope‘s (or „operation microscope“) 30 times magnifi cation and its optimised illumination of the working sur-roundings structures such as • very thin root canal orifi ces, • additional root canals • obliterated or root canals which are closed up with hard tooth substance • branched root canals • hairline cracks in the hard tooth substance can be easier or only be seen. Details which might otherwise remain invisible and untreated and thus become the reason for unsuc-cessful root canal treatment. Furthermore the treatment possibilities for such teeth which already have a root canal fi lling which does not comply with quality standards are increased.
These operating instructions describe all functions at maximum confi guration of the ATMOS® i View 31 DENT.
1.0 Introduction
6
1.4 Explanation of pictures and symbols
!
→
clickclick
Graphic symbols contained in this manual
Warning, special diligent notice!
Short cuts / symbols contained in this manual
Please press where dot indicates
Subnumeration
Numeration
General informationFollow the arrows whilst proceeding, sequence
Replace
Check
Please read, important information
Move, plug... in this direction
Engage, check correct fi t
Turn, shift... in this direction
Important information
Buttons on the operator panel / symbols of ATMOS® i View DENT
Light on / off (independent of automatic light control)
SN Serial number
Switch between the two light modes REF Order number
Video (start / stopp) Manufacturing date
Freeze frame The CE sign shows that this product meets the appropriate requirements of the ECDirectives.
Fuse Observe operator manual!
Output of the electronical current supply of the microscope(ATMOS® i View 21 DENT)
Potential equalisation acc. to IEC 60417-5021
Microscope (ATMOS® i View 31 DENT) Foot switch (ATMOS® i View 31 DENT)
S-video-output (ATMOS® i View 31 DENT) Output signals of the tilt sensor in the carri-er arm system (ATMOS® i View 31 DENT)
Record function (ATMOS® i View 31 DENT)
Freeze (ATMOS® i View 31 DENT)
2 Single use product - not for reuse.Exchange after use.
USB port (ATMOS® i View 31 DENT)
Do not look directly into the light source of the ATMOS® i View.
The carrier arm of the mobile stand must be brought into a position suitable for transportDo not lean against the device.
Weight adjustment for the carrier arm
1.0 Introduction
060.0604.0
Schild Transportst. MikolpLabel transport position Mikolp
1:1
01 9463/13 15.07.13 OEI
24.07.13 O.Eirich
Blatt(sheet) 1
Bl.1/1
(index)Zust.
(revision)Änderung Datum
(date)Name(name)
Maßstab (scale) Konstr. Nr.
Gepr.
Bearb.
Name
Erstellt
Datum
Ers.f. : Ers.d. :
Benennung (description)
Zeichnungs /Artikel-Nr.(part no.)
Alle Maße in mm/all dimensions in mmAllgemeintoleranzen /General tolerancesDIN ISO 2768 - mK
79853 Lenzkirch / Germany
ATMOS Medizin T echnik GmbH & Co. KG
Ludwig - Kegel - Str. 16
Tel: +49 7653 689 -0
Fax: +49 7653 689 -190
www.atmosmed.de
Sch
utz
verm
erk
(C
opyr
ight notic
e)
DIN
IS
O16016
A4
3M Folie7876EC+Laminat 7730FL
nicht bemaßte Radien R5
weißtransparentRAL 5005 SignalblauRAL 3001 Signalrotschwarz
02 9576/13 22.11.13 OEI
C.Reinhardt09.01.14
09.01.14 C.Reinhardt
7
1.5 Scope of supply
1.6 Transport and storage
The ATMOS® i View DENT may only be transported in a upholstered and protective shipping box.
Please note down and immediately report any damages which occured during shipping. Please use the attached QD 434 delivery complaint / return shipment - form when com-plaining or sending back. This form can also be downloaded from our website in the service section
www.atmosmed.com.
Surrounding conditions: Transport / storage: -10...+50 °C; 30...95 % humidity no condensation at an air pressure of 500...1060 hPa
Operation: +10...+35 °C; 30...95 % humidity no condensation at an air pressure of 700...1060 hPa
Microscope
Operating instructions
Microscope arm
Protective cover
Prior to dispatch, the ATMOS® i View DENT was subjected to an extensive functional test and was carefully packed. Nevertheless, please compare the contents of the shipment on completeness immediately upon receipt (see delivery note).
After transport of the ATMOS® i View DENT at temperatures below 0°C it should be kept at room temperature for at least six hours. If the ATMOS® i View DENT is not acclimatized it should not be used as damage to the electronic compo-nents could occur.
1.0 Introduction
8
!For your safety
The ATMOS® i View DENT is a device designed in line with IEC 60601-1-1/EN60601-1 and it is a device with protec- tion class I. In order to avoid the RISK of electrical shock, this unit may only be connected to a mains supply with properly installed earth conductor.
Power cables, accessories and access cables need to be checked for defects prior to setting up the ATMOS® i View DENT. Defect cables need to be replaced immediately.
The ATMOS® i View DENT may be used in supervised operation by qualifi ed personnel which has been trained for operating the appliance only.
The ATMOS® i View DENT is not designed to be used in an explosion-hazardous environment (M and G). This enviroment may be caused by the use of fl amable anaes- thetics, skin cleansing products and skin disinfectants.
If fl uids penetrated the ATMOS® i View DENT it needs to be sent in and may only be used after the check up of an ATMOS authorised person.
After the transport of the ATMOS® i View DENT in tempe- ratures below 0°C it needs to be kept at room temepe- rature for at least six hours. If the ATMOS® i View DENT is not acclimatised it may not be used as damages to the electronic components may be the result.
Do not plug in electric connections (plug, socket) under the use of force. If this is not possible check whether the plug fi ts the socket. If you should ascertain a defect in the con- nection you should have it repaired by our service.
Never look straight into the sun with lenses or eye lenses.
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! Make sure never to look directly into the light source yourself. > Damages to the eyes due to blinding may be the result.
An annual safety check needs to be executed and documented
Prior to every use the stands (all joints included) need to be checked for safe connections.
Take care that the patient is not touching the device or gets in contact with the device.
Risk of injuries! Take care not to roll the mobile stand over your feet when moving the stand
Please make sure to never blind the patient with the light source. Do never look directly into the light source.
Please observe the EMC guideline. Failure to follow this guideline can result in a hazard.
Dispose of wrappings accordingly.
Before connecting the ATMOS® i View DENT it needs to be checked whether the requested main voltage of the ATMOS® i View DENT matches the mains voltage of the mains power supply.
Use correct and undamaged plugs and extension cables only.
Unplug the ATMOS® i View DENT from the socket fi rst. Disconnect the connection line on the ATMOS® i View DENT afterwards only. Never touch plug or line with wet hands.
Take notice of the environmental conditions stated in the technical data (chapter 9.0).
The ATMOS® i View DENT fully complies with the electro magnetic immunity requirements of standard IEC 60601- 1-2 / EN 60601-1-2 „Electromagnetic compatibility - Medi- cal Electrical Equipment“.
ATMOS is not liable for personal injury and damage to property if • no original ATMOS parts are being used, • the advice for use in these operating instructions is not being observed, • assembly, new settings, alterations, extensions and repairs have been carried out by personnel not authorised by ATMOS.
Unplug the device immediately if you observe fumes, sparks or weird noises.
With every light source a warming of tissue due to absorp- tion may occur. Please make sure to reduce duration of use to a minimum. Switch off the light source when not in use, check heat development if neccessary.
Consider, when setting up the microscope, that the elastic force of the arm – without microscope head – is excee- dingly strong. Operate the break of the height adjustment carefully.
These operating instructions correspond with the construc- tion of the unit and with the current status of safety-related standards at the time of printing. Proprietary rights are existing for all described circuits, processes, names, soft- ware programs and units.
Make sure that the unit is positioned so that all the controls and the on/off switch are always accessible.
2.0 For your safety
9
Please note that only PCs and monitors with IEC 60601- 1/EN 60601-1/EN 60950-1 approval may be connected to the S-video outlet of the ATMOS® i View DENT supply module!
2.0 For your safety
During operation, the user is obliged to regularly check the microscope for proper function. In the unlikely
event of failure of the microscope, the user must take precautions to continue the treatment of the patient with suitable methods.
10
3.2 Assembly
5 fold magnifi cation changer (optional)
Wide fi eld eye piece lenses
Binocular tube
lens with fi ne focussing (optional)
Pivoting colour fi lters (optional)
brightness control
Lateral double hand grip (optional)
HD version(optional)
Endoscope adapter(optional)
Operator panel
Brake of the coupling
Measuring scale(optional) (see page 18)
Please make sure that the static conditions stated by ATMOS MedizinTechnik are met (for details see the separately enclosed document „Static requirements for installing the ATMOS i View“). The fulfi lment of these requirements must be confi rmed by an authorized expert.Mains voltage and fuse:Mains voltage: 100-240 V; 50/ 60 Hz, Fuse: 2 x T 3,15 APlease note that only PCs and monitors with IEC 606010-1/EN 60601-1 approval may be connected to the S-video outlet of the ATMOS® i View DENT supply module!
3.2.1 Connection to the mains supplyIn order to safely disconnect the device from the power supply the power cable must be removed from the IEC power connector of the power supply module! Potential equalisation:The ATMOS® i View DENT supply module has a rear connection for potential equalisation which can be connected to the potential equalisation rail in the room if need be. Hereby safety of user or patient can be increased especially in case of a defective earth con-ductor. For connecting the device’s potential equalisation plug with the potential equalisation rail of the room, please use the potential equalisation cord with REF 530.0030.0.
3.2.2 Microscope overview
3.0 Setting up and starting up
!
11
Ers.d. :
Zeichnungs /Artikel-Nr.(part no.)
Benennung (designation)
Werkstoff (material)
Konstr. - Nr:Mikolp-200-030.
Blatt(sheet)
Zust.(index)
Änderung(revision)
Datum(date)
Name(name)
Gepr.
Bearb.
NameDatum
Maßstab (scale)
1
Alle Maße in mmall dimensions in mmAllgemeintoleranzen /General tolerancesDIN ISO 2768 - mKüber 30 mm ±0,3
Ers.f.:
Erstellt
79853 Lenzkirch / Germany
ATMOS Medizin T echnik GmbH & Co. KG
Ludwig - Kegel - Str. 12, 14-16, 18
Tel: +49 7653 689 -0
Fax: +49 7653 689 -190
www.atmosmed.de
Sch
utz
verm
erk
DIN
IS
O 16016
-
13.01.2012 C.Reinhardt
1:1 -
Tasterfolie Gyn mit Atmos Logo
060.0600.0
16.03.2012 C.Reinhardt
Output of the electronical cur-rent supply of the microscope
Connection forpotential equalizationperformance acc. to IEC 60417-5021
IEC power plug with fuse inlay for the connection to the mains power supply
3.2.5 Rear View of the control device of the ATMOS® i View 31 DENT
USB-port for the transfer of the key status of the „Freeze frame“ and „Video recording functions“
Output signal of the „record function“
Output signal of the „Freeze framefunction“
Output signals of the tilt sensor in the carrier arm system
S-video-output of the integrated SD-camera
Connection for the supply of the microscope elec-tronics and control performance
Connection to the foot switch. Switches between light channels
3.2.3 Operating elements at the microscope
Light on / off (independent from the automatic light control)
Video recording(start / stopp)
Freezeframe
IEC power plug with fuse inlay for con-nection to the mains power supply
Display of the „permanent light“ mode - by pressing the mode but-ton a single time, the „permanent light“ mode can be switched on.
Connection forpotential equalizationperformance acc. to IEC 60417-5021
3.2.4 Rear view of the control device of the ATMOS® i View 21 DENT
3.0 Setting up and starting up
12
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3.3 Integration options
!
!
3.3.1 Mobile stand DENT
Please make sure that the microscope arm is in a retracted position when moving the mobile stand.
Risk of injury! Take care not to roll the mobile stand over your feet when moving the stand
When the device is placed in the working position the brakes must be locked.
Only monitors which do not exceed the following specifi cations can be adapted to the mobile stand.Maximal dimensions H x W x D: 60 x 40 x 10 cm, weight 9.8 kgThe stability of the mobile stand cannot be guaranteed for monitors which do not match these specifi cations.
3.3.2 Wall stand
Affi x to wall by use of a guide rail. The mounting of the microscope head is height adjustable.Recommendation: Please use a water level to true the wall stand!
3.4 Start up Remove the microscope from the packaging. Check whether the mains current on the type label corresponds with the mains power supply.
Check the scope of delivery
Peruse safety information in part 2.0 of this instruction manual before setting up the device for the fi rst time.
After transport of the microscope at low temperatures it should be kept at room temperature for at least six hours. If the ATMOS® i View DENT is not acclimatized it should not be used as damage to the electronic components could occur.
Consider, when setting up the microscope, that the elastic force of the arm – without microscope head – is exceedingly strong. Operate the break of the height adjustment carefully.
To activate the ATMOS® i View DENT please use the on/off switch on the front side of the control device.
3.5 Operating requirements Please note that the following requirements must be adhered to for the further application after the installation of the device:
All joints and connection parts which are responsible for the safety of the device are securely fastened and fi tted correctly.
All electronic connections (cables, plugs, power cables etc.) are in good order and condition.
The specifi ed mains voltage and frequency on the microscope corresponds to the supply network.
The microscope is connected to a safety connection socket with the provided mains cable.
Attention, never point or direct the beam into the patient´s eyes. Do not look directly into the light source.
With every light source, a warming of the tissue due to radiation and absorption could occur. This could result in damage to the biological tissue. Please keep the luminosity and duration of use at a minimum. Switch off the light source when not in use, check heat development if neccessary.
3.0 Setting up and starting up
13
3.6 Starting up at a glance
Adjust microscope to initial position on the microscope suspension by use of the fi xing wheel.Adjust microscope horizontally and vertically.
Adjust all the clamps on the carrier and suspension arm so that the free movement of the arm meets your requirements.
Swing microscope into working space.
Adjust binocular lens tubes by pressing / pulling the tubes together or apart. The interocular distance is perfectly adjusted when you look through with both eyes only a circular fi eld is visible!
Adjustment of the eyepieces.
Persons without glasses Persons with glasses
Eyepieces remain in initial posi-tion (eyepieces are pulled out). Dioptre scale adjusted to zero
People with defective vision and glasses
People with defective vision without glasses
(refraction values known)
People with defective vision without glasses (refraction
values unknown)
Keep glasses on, push eye-pieces in direction of the lens
tube until they snap into place. Adjust dioptre scale to zero.
remove glasses and adjust dioptre scale to appropriate
number on the eyepiece (eye-pieces are pulled out).
Remove glasses and adjust both eyepieces to +5 dpt.
Remove the lens tube from the microscope head and
focus on a distant object. The object is still blurred. Slowly turn the dioptre ring on the
fi rst eyepiece in a clockwise direction until the object is sharp. The other eye must remain closed. Repeat this
procedure a couple of times in order to determine an average value. Adjust the second eye-piece by the same procedure and reattach the lens tubes to the microscope head with the connective screw (eyepieces
are pulled out).
Adjust the 5 fold magnifi cation changer to maximum on the magnifi cation unit (2.5). Approach the object with the microscope (according to the chosen focal distance) until the image is sharp. If the zoom level is changed the degree of sharpness is still
maintained.
If neccessary the brightness can be adjusted by the rotary knob on the bottom of the device.
3.0 Setting up and starting up
14
4.1 Microscope suspension
rotating knob
set screws
By means of a corresponding suspension the microscope head is connected laterally to the microscope arm. The complete range of cables run through the suspension therefore no disturbing cables are visible from the outside (with the exception of the connection to the HD adapter and direct connection to a monitor). Due to a rotating knob, which is situated on the left side of the suspension, the microscope can be adjusted vertically to suit the individual requirements of the user.To fi x the microscope head turn the rotating knob towards you in a clockwise rotation. The „weightless motion brake“ included into the 30° swivel unit provides a sensitive individual adjustment of the motion strength so that the microscope head remains in every position, even with installed accessories, and thus enables you to continue the examination. To loosen the microscope head turn the rotaing knob towards you anti-clockwise.
Attention: Check the secure connection of the microscope to the suspension prior to every use!
4.2 Mechanical armRecommendation: Please use a water level to adjust the column! The microscope column must be in balance. The column is per-fectly adjusted when the stretched out microscope arm remains in all positions even with loosened brakes. When setting up the microscope, please bear in mind that the elastic force of the arm – without microscope head – is exceedingly strong. Operate the break of the height adjustment carefully.
The mechanical microscope arm can be adjusted via four set screws according to the individual requirements of the user. Choose the strength so that the free movement suits your re-quirements of the arm.For the fi xation of the arm turn the rotating knob in a clockwise direction. To loosen the arm turn anti-clockwise.
Attention:Prior to use please make sure that the brakes of the support arm are set correctly.
4.3 Hand gripsWhen purchasing the ATMOS i View DENT you may choose between two versions of handles.
4.3.1 Lateral double hand gripThe position of the lateral double hand grip can be gradually adjusted by simulataneously pulling and turning the handle.
4.0 Operation
15
4.4 Adjusting the interocular distanceThe interocular distance is adjustable between 50 - 75 mm. Swivel the microscope into the work space Look through the eye lenses and push or pull the lens tubes together or apart with both hands. The interocular distance is perfectly adjusted when you look through with both eyes and a circular fi eld is visible!
4.5 Adjusting the eye piecesPersons without glasses: Eyepieces remain in initial position. Inital position = the eye steering of the eyepieces are pulled out. Make sure that the zero of the dioptre scale complies with the index on the eyepieces.
Persons with glasses: People with defective vision should keep their glasses on and push the eyepieces in direction of the lens tube until they engage audibly. Adjust dioptre scale to zero.
People with defective vision with the known refraction measurement should take their glasses off and adjust the dioptre scale on the eyepieces to the matching number. The process of focussing is described in Chapter 4.9.
People with defective vision, without glasses with unknown refraction measurement adjust both eye-pieces to +5 dpt. Remove the binocular tube and the eyepiece from the microscope head and focus on a distant object*. The object still looks blurred. Slowly turn the dioptre ring of the fi rst eyepiece in clockwise direction until the object is sharp. The other eye must remain closed while adjusting the eyepiece.
Repeat this procedure a couple of times in order to deter mine on an average value. Adjust the second eye-piece by the same procedure and reattach the lens tubes to the microscope head with the connective screw. The process of focussing is described in Chapter 4.9
* Never use the sun as an object!
4.0 operation
16
4.6 Exchange of the lenses
Lens
5x changer
The designated thread on the microscope head allows for easy exchange and fi xation of the various lenses. Due to the integrated screw the lense can be loosened by turning it to the left hand side and fi xated by turning it to the right.
4.7 Exchange of lenses with manual fi ne focusing
Mount lens as described above and secure it with the intermediate screwed ring.
4.8 Adjustment of the 5 fold magnifi cation changer
ATMOS‘ 5 fold magnifi cation changer enables a free range zoom from 0.4x up to 2.5x. Select the desired zoom factor by adjusting one of the lateral rotating knobs. Pay attention that the chosen zoom factor engages audibly with the groove. Freely adjustable zoom factors: 2.5 - 1.6 - 1.0 - 0.63 - 0.4. The magnifi cation which points in the direction of the eyepiece is the current magnifi cation.
4.0 Operation
17
4.9 Focussing
Undo screw
Binocular angled lens tube 45°
Binocular straight lens tube
Loosen screw
Fine focussing
Adjust the zoom to maximum (2.5) on the magnifi cation unit. Approach the object with the microscope (according to the chosen focal distance) until the image is sharp. If the zoom level is changed the degree of sharpness is still maintained. 4.9.1 Fine focussingThe optional fi ne focussing allows for sensitive and precise fo-
cussing in a 17 mm range. Fine focussing is neccessary in order to focus accurately while zooming in. Replace the mounted lens with the appropriate lens for fi ne focussing (simple mounting due to the screw mount at the microscope head. Secure with the intermediate screwed ring). Conduct the focussing as described above. Adjust focus by use of the lateral adjusting disk.4.10 Exchange of the binocular tube
The tubes focal distance of 160 mm allows for a comfortable and
fatigue-proof observation of the object with both eyes. Working is made easier due to the exceptionally large exit pupil and an increased stereo base of 24 mm.Please adhere the lense tube while loosening the screw. Otherwise the lense tube could drop. loosen the screw on the top of the lense tube and remove the tubes from the microscope head. Make sure that the gudgeons and grooves of the dove tail engage and the tubes lie fl at. Tighten the screw again. Check for a secure fi t.4.11 Binocular rotary disk with detent
The rotary disk allows to raise the swivel tube at an angled posi-
tion of the microscope head and should therefore simplify to look through the tubes. If the tubes are rotated over the detent a loss of light or vignetting could occur.
4.0 Operation
18
0,5 mm 2 mm10 mm20 mm
2 mm5 mm
4.12 Pivoting colour fi lter
pivoting colour fi lter
Measuring scaleNot true to scale
The scale is for guidance only and may not be used for measuring absolute quantities.
The pivoting colour fi lter prevents the premature hardening of composite fi llings.
Turn the function knob by 90° in a clockwise direction to swing in the colour fi lter. By turning the knob by 90° in an anti-clockwise direction the fi lter is removed from the optical beam path of the microscope.
4.13 Microscope zoom and object fi eld size
Lense f in mm equals the ap-proximate wor-king distance
Factor display on the magnifi cation unit Eyepieces with lens tubesf = 160 mm
0,4 0,63 1* 1,6 2,5Total zoom / visual fi eld Ø in mm
200 3,2 / 50 5,0 / 40 8,0 / 25 12,8 / 15,6 20 / 10 10 x250 2,6 / 62,5 4,0 / 50 6,4 / 31,5 10,2 / 19,7 16 / 12,5 10 x300 2,1 / 75 3,4 / 60 5,3 / 37,5 8,5 / 23,4 13,3 / 15 10 x400 1,6 / 100 2,5 / 80 4,0 / 50 6,4 / 31,3 10 / 20 10 x
* Read off at factor 1 when using the microscope zoom without the zoom unit.
4.14 Measuring scale
Via a small turning knob beneath the lens a true to scale dimension scale can be faded into the fi eld of the illumination light path. This documentation display enables the measurement of objects regardles of the selected magnifi cation. The scale will be displayed in both the 3D-picture and on all camera pictures and as required can be faded out at any time. To fade-in the scale turn the knob by 45° in a clockwise direction. Via a 45° rotation in anti-clockwise direction the scale can be faded out from the illumination light path.The following measures and distances have to be observed: Distance 2 mm, Line width 0.5 mmPlease note that these specifi cations are only correct for the following combinations:Measuring scale for 200 mm lenses or 200 mm lenses with fi ne focusing and wide angle eyepieces 10x
4.0 Operation
19
Ers.d. :
Zeichnungs /Artikel-Nr.(part no.)
Benennung (designation)
Werkstoff (material)
Konstr. - Nr:Mikolp-200-001.
Blatt(sheet)
Zust.(index)
Änderung(revision)
Datum(date)
Name(name)
Gepr.
Bearb.
NameDatum
Maßstab (scale)
1
Alle Maße in mmall dimensions in mmAllgemeintoleranzen /General tolerancesDIN ISO 2768 - mKüber 30 mm ±0,3
Ers.f.:
Erstellt
79853 Lenzkirch / Germany
ATMOS Medizin T echnik GmbH & Co. KG
Ludwig - Kegel - Str. 12, 14-16, 18
Tel: +49 7653 689 -0
Fax: +49 7653 689 -190
www.atmosmed.de
Sch
utz
verm
erk
DIN
IS
O 16016
-
27.03.3013 C.Reinhardt
1:1 -
Tasterfolie
060.0621.0
MODE
LED AFDSTROBO
4.15 Integrated cameraIntegrated SD-camera with single-hand operation at the microscope head:
After setting up the microscope (see chapter 3.4 rear view of ATMOS i View DENT) control signals can be triggered via the buttons on the operating panel which are available on the rear side of the service module. When using the software ATMOSoft or ATMOS Med Doc the USB port is connected to the computer. Pictures can be saved by pressing the button. By pressing the button the recording of video sequences can be started/stopped.
For other recordings the output “Freeze” and “Record” are availa-ble with which these devices can be controlled via the operating buttons.
4.16 Endoscope adapterThe standardized endoscope adapter allows for an easy connec-tion to an external ATMOS Cam or other external endoscope or digital camera (third party products). The ATMOS® Cam can be easily and swiftly attached to the endoscope adapter by means of a special clip seal. Other endoscope cameras which have a standardised connection interface may also be adapted without any trouble. To attach an external digital camera, a special adapter (which is suitable for respective cameras) is required.
4.17 HD adapterDue to the especially developed HD-adapter it is possible to connect a digital camera with an e-mount bayonet (e.g. Sony Nex 5/7) to your ATMOS® i View DENT. This camera enables you to take and archive HD resolution pictures.By connecting an IR remote control to the power supply module the operator panel on the microscope head may also be used with the external camera with e-Mount connection.
At dispatch the HD adapter is covered with a cover cap.This cap is to protect against contamination and has to be re-attached at any time e.g. if the camera is removed or when the adapter is unused.
Please make sure that externally connected cameras do not exceed a weight of 300 g.
4.0 Operation
20
5.2 Cleaning the mechanical microscope surface
5.1 Instructions for cleaning and carePrior to cleaningMedical microscopes like the ATMOS® i View DENT need to be fail-safe and absolutely reliable at all times. Therefore we recommend prior to every use:
if
required
!
The described measures relating to cleaning and disinfection resp. sterilisation do not substitute the relevant instructions which must be adhered to prior to operation! All disinfectants used for the disinfection of the ATMOS® i View DENT must be authorised products.
Always observe the concentration specifi cations and instructions by the respective manufacturer!
All mechanical surfaces of the ATMOS® i View DENT must be wiped and disinfected after each application. Do not use aggressive or abresive cleansing agents.Residues can be removed with a mixture made from equal parts of ethyl alcohol and distilled water to which a drop of a standard washing-up liquid is added.
If liquid has penetrated into the microscope it must be checked by an authorised customer service before it can be used again.
Disconnect the plug from the mains current prior to cleaning and disinfecting the microscope surface.
The surfaces of the ATMOS® i View DENT can be cleaned / wiped with the following disinfectants.
• ATMOS Green & Clean SK • Dismozon pur • Perform • Bacillol 30 Foam
When using disinfectants containing aldehyde and amine at the same object colour changes may occur.
For a sterile protection of the device the single use sterilization drapes may be used. Affi x the cover loosely so that there is enough room left for the microscope holder and the operation microscope. The drapes must be especially loose around the hand grips. As the surgeon must be able to use the operating elements though the cover.
Do not use
• disinfectants which contain organic or inorganic acids or bases as they could cause corrosion damage. • disinfectants which contain chloramides or phenol derivates as they could cause stress cracking in the material which is used for the microscope body.
5.0 Cleaning
21
5.3 Cleaning of lenses / eyepieces
WHAT HOW WHEN Details
C D S
after each application
daily
weekly
monthly
Cabinet X X X Manual wiping and disinfectionLense / optic X X X Manual wiping and disinfectionApplication parts* X X X Manual wiping and disinfectionn
protection covers (disposables) X Single use product -> not for processing, change after use
Hand grips X X X Manual wiping and disinfection
5.3.1 Cleaning optical surfaces
The multilayer T* (T-star) coating of the optical components (e.g. eyepieces, lenses) results in optimum image quality. Image quality could be reduced even by the slightest contamination of the optics or by fi ngerprints. In order to protect the internal optics, the instrument 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 from dust. Lenses, eyepieces and accessories which are not in use should always be stored in dust-free cases. The external surfaces of optical components (eye-pieces, lenses) should only be cleaned when required:• Do not use any chemical cleaning agents.• Dust which has accumulated on the optical surfaces can be blown off or removed with a soft, clean brush.
5.3.2 Optical surface of the endoscope connection
The endoscope connection is protected against contamination and humidity by an end glass cover. This glass cover must also be cleaned like the other optical surfaces of the ATMOS® i View DENT.The endoscope connection is protected against contamination and humidity with a cover. 5.3.3 Fogging of optical surfaces
To prevent the eyepiece optics from fogging, we recommend using an anti-fogging agent.
Note:Anti-fogging agents which are used by opticians for eyeglass lenses are also suitable for ATMOS optics.• Please observe the instructions supplied with each anti-fogging agent.Anti-fogging agents do not only ensure fog-free optics they also clean and protect them against dirt, grease, dust, fl uff and fi ngerprints.5.4 Hygienic plan
C= Cleaning, D= Disinfection, S= Sterilization
* Application parts Knobs to adjust (colour fi lter, measuring scale, 5 fold magnifi cation changer, operator panel, adjusting screws on the arm)
5.0 Cleaning
22
clickclick
+...
+...
6.1 General advice
!
Prior to exchanging the main fuse the system must be disconnected from the power supply.For this it is necessary to unplug the power cord from the power outlet.
Fuse exchange
Brake for star grip REF 538.2013.0
Prior to every application a visual inspection of the microscope and microscope connection line must be performed. Damaged cables must be replaced immediately!
Maintenance, opening and repair work on the device may only be executed by ATMOS or their authorised partners. The tech-nical and hygienic safety precautions and service instructions of the ATMOS® i View DENT must be adhered to.
An annual safety-related control is required. We recommend an inspection of the product during this safety-related control.
For repair works this microscope can be sent either directly to ATMOS or via the retailer you purchased it from.
Prior to shipment the microscope must be thoroughly cleaned and all surfaces disinfected.
ATMOS neither guarantees for fault-free operation nor for personal injuries and damage to property if
• no original ATMOS parts are used, • the operating instructions given in this manual are
not adhered to, • assembly, new settings, alterations, extensions and
repairs have not been executed by ATMOS autho- rised personnel.
There are no warranty claims whatsoever on defects or mal-functions which arise from the use of third party accessories or consumables.
The instructions and regulations for the respective fi eld of application should be observed.
6.2 Exchange of spare parts
FuseT3,15A/H 250V REF 008.0751.0
6.0 Maintenance and Service
23
Description Possible causes ProcedureATMOS® i View DENT cannot be switched on
mains cable is not connected,fuse is defect
plug inexchange fuse
ATMOS® i View DENT is hotplease ensure suffi cient air ventilation.switch off and let cool down for 2-3 hours
ATMOS® i View DENT overheats please contact the ATMOS serviceno function whatsoever ATMOS® i View DENT is switched off switch on at the connection box
5 fold magnifi cation changer is defective contact the ATMOS service
arm follows
tie bar is not vertically adjusted The polyamide extensions of the set screws are worn out or are not into place.
adjust tie bar,
exchange or fi x the extensions of the set screwscontact the ATMOS service
too little or no light at all
ATMOS® i View DENT moved into „par-king position“ and thereby switched off the light.
pull ATMOS® i View DENT into working position
malfunction of the LED light sourcecontact the ATMOS service
extreme decline in the LED light sourcelight source is dimmed down too low increase brightness of the light source
7.0 Troubleshooting
24
8.0 Options and Accessories
ATMOS® i View 21 DENT set
ATMOS® i View 21 DENT
Orange fi lter
Lens 250 mmwith manual fi ne focussing (17 mm)
5 fold magnifi cation changer (0.4/0.6/1/1.6/2.5)
2 x wide fi eld eyepiece lenses 10 fold, can be plugged in, with dioptre compensation and a spectacle wearer eyepiece lens
Lateral double hand grip for the ATMOS® i View DENT, grip for the manual bracket is steplessly adjustable
Mechanical support shaft PRO
Binocular swivel tube
Binocular rotary disk with detent
Options
Binocular angled lens tube 45°, f = 160 mm
Mobile stand PRO
Wall mount
25
8.0 Options and Accessories
ATMOS® i View 31 DENT set
ATMOS® i View 31 DENT
Orange fi lter
Lens 250 mmwith manual fi ne focussing (17 mm)
5 fold magnifi cation changer (0.4/0.6/1/1.6/2.5)
2 x wide fi eld eyepiece lenses 10 fold, can be plugged in, with dioptre compensation and a spectacle wearer eyepiece lens
Lateral double hand grip for the ATMOS® i View DENT, grip for the manual bracket is steplessly adjustable
Mechanical support shaft PRO
Binocular swivel tube
Binocular rotary disk with detent
HD adapter for a digital camera with a Sony E-mount bayonet connection (e.g. SONY NEX)
Options
Binocular angled lens tube 45°, f = 160 mm
Mobile stand PRO
Wall mount
26
Current state of technical data: 06.02.2013
Voltage 100-240 V~ ± 10 %; 50/60 Hz
Power consumption max. 45 VA
Fuses 2x T3, 15A / 250 V (100A@ 250VAC / 10000A@ 125VAC)
Fuse F1: T4,0A / 250 V (40A)Fuse F2: T1,0A / 250 V (35A)Fuse F3: T200mA / 250 V (35A)Fuse F4: T200mA / 250 V (35A)
Light output min. 120 kLux (200 mm) min. 80 kLux (250mm) min. 55 kLux (300 mm) min. 30 kLux (400 mm)
Colour temperature 5.500 K ± 10 %
Operation time permanent operation
Cooling fanless/ passive
Protective earth conductor resistanceEarth leakage currentEnclosure leakage currentPatient leakage current
max. 0,1 Ωmax. 0,5 mAmax. 0,1 mAmax. 0,1 mA
Surrounding conditionstransport / storage
-10...+50°C30...95 % humidity, no condensationair pressure 500...1060 hPa
Surrounding conditionsoperation
+10...+35°C30...95 % humidity, no condensationair pressure 700...1060 hPa
Weight 3.65 kg - 5.6 kg
Recurring safety controls An annual safety-related control must be executed in accordance with the accident prevention regulations. ATMOS recommends to perform an annual inspection.
Safety class (EN 60601-1) l
Safety type IP X0
Classifi cation in accordance with appendix IXEC Directive 93/42/EEC Class l (according to regulation no. 12)
CE-Marking CE
GMDN-code 35191
UMDNS-code 12-536
Suitable for operation up to an altitude above sea level of ≤ 3000m
REF 538.9000.0, 539.9000.0
9.0 Technical data
27
The ATMOS® i View DENT does not contain any hazardous materials.
The housing is recyclable.
Pay attention to a careful separation of the different materials.
Please observe national disposal regulations (e.g. waste incineration).
Disposal within the EC
The device described above is a high-quality medical product with a long service life. After its life cycle it must be disposed of profes-sionally. According to the EC directives (WEEE and RoHS) the device may not be disposed of in domestic waste. Please observe the existing 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 such microscopes could be contaminated. Therefore, according to the regulations of the EAR (Stiftung Elektro-Altmikroskope Register) is this type of microscopes excluded from the ElektroG regulations. In order to guarantee a proper disposal of your old device, please either pass on your old device to your specialised dealer or send it directly to ATMOS MedizinTechnik for a professional disposal.
Before disposal respectively before transport, the device surface must be disinfected.
10.0 Disposal
28
11.1 Guidelines and Manufacturer‘s Declaration - Electromagnetic Emissions The ATMOS® i View DENT is intended for use in the electromagnetic surrounding specifi ed below. The customer or user of the ATMOS® i View DENT should ensure that it is used in such an environment.
Emissions Test Compliance Electromagnetic Environment - GuidanceRF Emissions CISPR 11
Group 1 The ATMOS microscope uses RF energy only for its internal func-tion. Therefore, its RF emissions are very low and are not likely to cause any interference to nearby electronic equipment.
RF Emissions CISPR 11
Class BThe ATMOS® i View DENT is suitable for use in all establish-ments, including domestic, and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
Harmonics IEC 61000-3-2 Class AFlicker IEC 61000-3-3
applicable
11.2 Guidelines and Manufacturer‘s Declaration - Electromagnetic ImmunityThe ATMOS® i View DENT is intended for use in the electromagnetic environment specifi ed below.The customer or user of the ATMOS® i View DENT should ensure that it is used in such an environment.
Immunity Test IEC 60601- Test Level Compliance Level Electromagnetic Environment - Gui-
danceESD IEC 61000-4-2
± 6 kV Contact
± 8 kV Air
± 6 kV Contact
± 8 kV Air
Floors should be wood, concrete, or ceramics tile. If fl oors are synthetic, the relative humidity should be at least 30%.
EFTIEC 61000-4-4
± 2 kV Mains
± 1 kV I/Os
± 2 kV inapplicable for power cables± 1 kV for input and output cables
Mains power quality should be that of a typical commercial or hospital environment.
SurgesIEC 61000-4-5
± 1 kVdifferential mode
± 2 kVcommon-mode
± 1 kVdifferential mode
± 2 kVcommon-mode
Mains power quality should be that of a typical commercial or hospital environment.
Power Frequency 50/60 HzMagnetic fi eld IEC 61000-4-8
3 A/m applicable
3 A/m
Power frequency magnetic fi elds should be that of a typical commercial or hospital environment.
Medical electrical microscopes are subject to special precautions with regard to EMC and must be installed acc. to following EMC notes. Portable and mobile HF communication equipment can influence medical electrical microscopes. The use of other accessories, other converters and cables other than those stated could lead to an increased emission or a reduced interference immunity of the equipment or system.
11.0 Notes on EMC
29
Immunity Test IEC 60601-Test Level
Compliance Level Electromagnetic Environment - Gui-dance
Voltage Dips / DropoutIEC 61000-4-11
< 5 % UT (> 95 % Dip of the UT) for 0.5 Cycle
40 % UT(60% Dip of the UT) for 5 Cycles
70% UT(30 % Dip of the UT) for 25 Cycles
< 5 % UT (>95 % Dip of the UT) for 5 s
< 5 % UT (> 95 % Dip of the UT) for 0.5 Cycle
40 % UT(60% Dip of the UT) for 5 Cycles
70% UT(30 % Dip of the UT) for 25 Cycles
< 5 % UT (>95 % Dip of the UT) for 5 s
Mains power quality should be that of a typical commercial or hospital environment. If the user of the ATMOS® i View DENT requires continued function during interruptions of the energy sup-ply, it is recommended to supply the ATMOS® i View DENT from an uninterruptible power supply or a battery.
NOTE UT is the alternating mains voltage prior to application of the test levels.
11.3 Guidelines and Manufacturer‘s Declaration - Electromagnetic Immunity The ATMOS® i View DENT is intended for use in the electromagnetic environment specifi ed below. The customer or user of the ATMOS® i View DENT should ensure that it is used in such an environment.
Immunity Test IEC 60601-Test Level Compliance Level Electromagnetic Environment - Guidance
Conducted RFIEC 61000-4-6
V1 = 3 Veff150 kHz to 80 MHz 3 V Portable and mobile communication equipment should
be separated from the ATMOS® i View DENT incl. the cables by no less than the distances calculated / listed below.
Recommended distances:d = [ 3,5 / V1] √P
d = [ 3,5 / E1 ] √P80 MHz to 800 MHz
d = [ 7,0 / E1 ] √P800 MHz to 2500 MHz
Where „P“ is the max. power in watts (W) according to the manufacturer and D is the recommended safety distance in meters (m).
Field strengths from fi xed transmitters, as determined by an on-site (a) survey, should be less than the compli-ance level (b). Interference may occur in the vicinity of microscopes which bear the following symbol
Radiated RFIEC 61000-4-3
E1 = 3 V/m80 MHz to 2,5 GHz
3 V/m
11.0 Notes on EMC
30
11.4 Recommended safety distance between portable and mobile RF Communications equipment and the ATMOS® i View PRO DENT
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 emanation of electromagnetic waves is affected by absorption and refl ection of buildings, objects and people.a The fi eld strength of stationary transmitters, such as base stations of cellular phones and land mobile radio microscopes, amateur radio transmitters, cbm broadcast and TV stations cannot be exactly predestined. To determine the electromagnetic environment in regard to stationary transmitters, a study of the location should be considered. If the measured fi eld strength at the location where the ATMOS® i View DENT is used exceeds the above compliance level, than the ATMOS® i View DENT must be observed to verify the normal operation. If abnormal performance characteristics are noted, additional measures may be necessary, e. g. a changed arrangement or another location for the device.
b Within the frequency range of 150 kHz to 80 MHz the fi eld strength should be below 3 V/m.
The ATMOS® i View DENT is intended for use in an electromagnetic environment in which radiated HF disturbances are controlled. The customer or user of the ATMOS® i View DENT can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF Communications equipment and the ATMOS® i View DENT as recommended below, depending on the maximum output power of the communications equipment.
Safety distance, depending on transmit-frequency mNominal output of the
transmitter
W
150 kHz to 80 MHz
d = [ 3,5 / 3] √P
80 MHz to 800 MHz
d = [ 3,5 / 3] √P
800 MHz to 2,5 GHz
d = [ 7,0 / 3] √P
0,01 0,12 0,12 0,2330,1 0,37 0,37 0,741 1,16 1,16 2,3310 3,69 3,69 7,38100 11,66 11,66 23,33
For transmitters for which the maximum nominal output is not indicated in the above table, the recommended safety 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 the manufacturer´s specifi cation.
NOTE 1 By 80 MHz and 800 MHz the higher frequency range applies.
NOTE 2 These guidelines may not be applicable in all cases. The emanation of electromagnetic waves is affected by absorption and refl ection of buildings, objects and people.
11.0 Notes on EMC
31
For your notes
MedizinTechnik
This document is copyrighted. Duplication, translations, microfilming and savings on electronic systems, particularly for commercialpurposesare illegal without prior agreement of the manufacturer. All compiled data are based on manufacturers instructions. All logos,product names and designations used in this document are property of the respective manufacturer.We do not take over any warranty and liability in the case of missing inscriptions. Subject to modifications and amendments.
1. General:Our General Standard Terms and Conditions apply exclusively. Client’s terms and conditions which are contrary to or deviate from our General Standard Terms and Conditions are not recognised unless their validity is explicitly confirmed in writing. Our General Standard Terms and Conditions also apply even if we deliver to clients without reservation, in the knowledge of the client’s contrary terms and conditions. Our General Standard Terms and Conditions also apply to all future business with that client.
2. Proposal - Order Confirmation Our proposals are subject to change without notice unless otherwise stated in our order confirmation. Each order is only accepted by us following our written order confirmation.
3. Orders Every order requires an exact description of all of our product’s details. We assume no liability for errors and damage caused by inaccurate or incomplete ordering details.
4. Prices Unless otherwise stated in the order confirmation, our prices in the order confirmation are ex factory prices and exclude packaging and value added tax. Packaging is charged separately at cost price in the invoice. Value added tax is charged separately in the invoice according to the legal rate on the invoice date. We reserve the right to change prices appropriately should price reductions or increases, especially due to wage settlements, changes in the price of materials or currency fluctuations, be incurred. Proof of such changes will be provided for the client on request.
5. Payment Conditions - Balancing Unless otherwise stated in the order confirmation, our invoices are payable with a 3% discount within 10 days (except for repair and assembly services) or within 21 days from the invoice date net cash; money receipts is decisive for complying with this term. We are entitled to charge interest after the due date at a rate 2% above the relevant basic interest rate of the German Federal Bank. Should the client have payment arrears, we are entitled to charge interest on arrears at a rate 5% above the relevant basic interest rate of the German Federal Bank. Should we be able to prove higher damages due to arrears, we are also entitled to claim these. The client only has the right to balance invoices against its own claims should such claims be confirmed in a court of law or recognised by us. The client does not have the right of retention due to disputed counterclaims.
6. Delivery Periods Fulfilment of our delivery duties requires the punctual and proper fulfilment of the client’s duties. The right to defense on the grounds of an unfulfilled contract is reserved.Should the client default in accepting the goods delivery or breach other cooperation duties, we are entitled either to withdraw from the contract or claim compensation for any increased costs incurred up to that time without setting a further deadline. The right to make further claims is reserved. Furthermore, in such cases, the risk of coin-cidental destruction or a coincidental deterioration in the quality of the delivered goods is transferred to the client in the case of default in accepting such goods or payment arrears. Acts of God or stoppages (due to insufficient supplies of material, industrial disputes etc.) entitle us either to demand an appropriate extension of delivery periods or to partly or entirely dissolve the delivery contract. This does not give the client the right to claim damages. We have fulfilled delivery periods if the delivery goods have left our factory or the client has been informed of the goods’ readiness for delivery within such delivery periods. Delivery periods stipulated by the client are not recognisedby us unless they form part of our order confirmation. We adhere to legal terms and conditions in cases where, as a result of an undue delay in the delivery for which we are liable, the client is entitled to claim that his interests in a continued fulfilment of the contract have ceased. We also adhere to legal terms and conditions should a delay in delivery be caused by deliberate or grossly negligent action by us or our representatives for which we are responsible. We are also responsible for such actions by our representatives or agents. Should the delivery delay not be caused by our deliberate infringement of contractual duties for which we are responsible, our liability is limited to damage which is regarded as typical for that case. We are liable according to the legal terms and conditions if and in so far as the delivery delay for which we are responsible is caused by an infringement of a substantial contractual duty. In such cases, our liability is also limited to damage which is regardedas typical for that
case. Should the delivery delay be caused by a culpable infringement of non-substantial contractual duties, our client is also entitled to claim a one-off damage compen-sation worth 3 percentage points of the delivery value of the goods for each week’s delay, up to a maximum which is no higher than 15 percentage points of the delivery value of the goods
7. Delivery - Familiarisation In the case of the delivery of devices for the medico-technical industry which require assembly and/or familiarisation for the final customer using specialist trade personnel (such as Ear, Nose and Throat Apparatus and Suction Units), we reserve the right to deliver the goods exclusively to the relevant specialist traders. Should the trader not carry out assembly and/or familiarisation for the final customer, this is carried out by us. In such cases, we reserve the right to charge the client for the additionally created costs. Our specialist traders operate a recording system so that, if necessary, our products can be traced to the final customer. The specialist trader undertakes to immediately report to us all events and risks which must be reported in connection with our products.
8. Passage of Risk - Packaging Unless otherwise stated in our order confirmation, delivery is agreed ex factory. The risk of the goods’ damage or loss is therefore transferred to the client as soon as the goods leave the factory or the client is in default of acceptance of the goods. This also applies to cases where we confirm prepaid carriage. Transport packaging and all other packaging according to the packaging regulations is not returnable. Our client is responsible for disposing the packaging at its own cost. Our deliveries are insured by us at the client’s expense unless explicitly otherwise agreed. No insurance is arranged in the case of goods which are collected by our clients. In the case of transport damage, claims are only handled if the client receives confirmation of any damage, reduced weight or loss by the shipping company before accepting the delivery.
9. Warranty The client is responsible for examining the delivered goods immediately after receiving them to determine any eventual deficiencies or delivery errors, and to report these immediately. Should the client fulfil this examining and reporting responsibility, and should payment conditions be fulfilled, we shall be liable to the client within the scope of legal regulations. Our period of warranty shall in all cases be two years. Our client can make use of the warranty as follows, so long as he can provide first buyer proof (in the form of an invoice or delivery note) and provided that the product still has the original, unchanged serial number: a. We choose whether to fulfil our guarantee by providing repair
services free of charge - either on the client’s premises or in our factory - or replacing the product. We can also provide these guarantee services through an authorised company;
b. Should a product be returned to us, the client agrees to send the product in its original or similar packaging, offering the same protection as the original packaging, to our address or any address notified by us.
c. Our guarantee ceases to apply if changes of any kind have been made to our product, unless such changes have been made by us or a company authorised by us, or have been previously agreed upon in writing by us. Our guarantee also ceases to apply if third parties have carried out repairs to our products or replaced parts thereof. This applies regardless of the fact whether these measures individually or collectively led to a deficiency of the product;
d. We accept no responsibility for damage defects caused by - operational wear and tear; - incorrect installation or incorrect or insufficient maintenance; - incorrect operation of the product (in contradiction to the operating instructions delivered with the product); - improper use or operating faults; - inappropriate or negligent handling and care, especially with respect to dirt, lime, suction of fluids, inappropriate cleaning and sterilisation;
- using accessories and/or replacementpartswhich are not explicitly approved; - incorrect assembly and/or initial operation by the client or third parties; - the client’s negligence in handling the product; - unacceptable operating conditions, such as humidity, temperatures, the power supply, vibrations. - accidents, acts of God, especially lightening, water, fire, public unrest and insufficient ventilation. We are not liable for damage to other objects apart from our product itself, except in thecase of any deliberate or grossly negligent actions by us or our representatives or agents. Should no deliberate breach of contract be claimed, our liability
is limited to damage which is regarded as typical for tthat case. This also applies in the case of our culpable infringement of substantial contractual duties The indispensable conditions of German Liability Law remain unaffected thereby. - For second-hand equipment, the period of warranty shall be reduced to a period of twelve months.
10. Reservation of Ownership We retain ownership of our goods until the receipt of all payments arising from the business relationship, including all demands arisingfrom installation orders, subsequent orders, repairs, accessory deliveries and replacement orders. Should we have agreed upon payment on the basis of cheque and bill transactions, the ownership reservation applies until the cheque received byus has been paid in, and does not expire through our credit upon receiving the client’s cheque. In the case of a breach of contract by the client, especially payment arrears, we are entitled to repossess our goods. Repossession of our goods repre-sents a withdrawal from the contract, unless explicitly declared in writing by us. We have the right to utilise the product after its repossession, whilst the income form such use is balanced against the client’s arrears, after deducting appropriate utilisation costs.The client is responsible for handling the goods with care. Should maintenance and inspection work be necessary, the client must carry these out punctually at his own cost. Our client is entitled to sell the goods he has bought from us in a proper sale transaction. However, he must immediately assign all outstanding claims to the value of the final invoice sum (including value added tax) of our claims to his customers or third parties. The client is entitled to collect this claim even after such assignment. Our right to collect the claim ourselves remains unaffected thereby.We undertake to release the securities to which we are entitled if requested to do so by the client should the realisable value of the our securities be more than 10 percentage points higher than the outstanding claims. We reserve the right to choose the securities to be released.
11. Plans and Illustrations We retain ownership of and copyrights to all plans, illustrations, calculations and other documents which are attached to our proposals. The client must receive explicit written permission before passing these on to third parties. Imitating our legally patented products is forbidden and will be prosecuted.
12. Jurisdiction and Place of Performance Our central office is the place of performance for all disputes in connection with these General Standard Terms and Conditions and the contracts closed with clients under them. This jurisdiction excludes other jurisdiction relating to persons or subject-matter. Furthermore, our client is not entitled to bring charges against us in another court should he file counter-charges, carry out counterbalancing or declare retention. We, however, are entitled to bring charges against our client at their general place of jurisdiction or at another relevant court recognised by German or foreign law.Unless otherwise stated in the order confirmation, our central office is the place of performance.
Lenzkirch, September 2008ATMOS MedizinTechnik GmbH & Co. KG79853 Lenzkirch/Germany
ATMOS General terms and conditions
