Atmos i View PRO, i View 31 PRO, i View 21 PRO Operating Instructions Manual
ATMOS® i View PRO
GA1GB.120102.0
2018-04 Index: 17
Operating Instructions
English
2
Table of contents
Further information, accessories, consumables and spare
parts are available from:
ATMOS
MedizinTechnik GmbH & Co. KG
Ludwig-Kegel-Straße 16
79853 Lenzkirch
Germany
Phone: +49 7653 689-0
Fax: +49 7653 689-190
+49 7653 689-292 (Service Centre)
atmos@atmosmed.de
www.atmosmed.com
4.5 Adjusting the eye pieces .....................................16
4.6 Exchanging the lenses ........................................17
4.7 Exchanging the lenses with manual ne
focusing...............................................................17
4.8 Exchanging the VarioFocus lens .........................17
4.9 Adjustment of the 5 fold magnication changer ..17
4.10 Focussing............................................................18
4.10.1 Fine focussing .....................................................18
4.11 Exchanging the binocular tube............................18
4.12 Binocular rotary disk with detent .........................18
4.13 Pivoting colour lter.............................................18
4.14 Shadowless illumination......................................19
4.15 Microscope zoom and object eld size ...............19
4.16 Measuring scale ..................................................19
4.17 Image and video recording .................................20
4.17.1 Adjusting the light mode of the integrated HD
camera ................................................................20
4.18 Endoscope adapter .............................................21
4.19 HD adapter..........................................................21
5.0 Cleaning and care .............................................22
5.1 General information on cleaning
and disinfection ...................................................22
5.2 Cleaning the mechanical microscope surface ....22
5.3 Cleaning of lenses / eyepieces ...........................22
5.3.1 Cleaning optical surfaces ....................................22
5.3.2 Optical surface of the endoscope port ................22
5.3.3 Fogging of optical surfaces .................................23
5.4 Recommended surface disinfectants ..................23
5.5 Hygiene plan .......................................................23
6.0 Maintenance and Service .................................24
6.1 Basic instructions ................................................24
6.2 Sending in the device..........................................24
6.3 Exchange of spare parts .....................................24
7.0 Troubleshooting ................................................25
8.0 Accessories and Options .................................26
9.0 Technical data ...................................................27
10.0 Disposal .............................................................28
11.0 Notes on EMC ....................................................29
1.0 Introduction .........................................................3
1.1 Notes on operating instructions ............................3
1.2 Intended use .........................................................4
1.3 Function ................................................................5
1.4 Explanation of pictures and symbols ....................6
1.5 Scope of supply ................................................... 7
1.6 Transport and storage ...........................................7
2.0 For your safety ....................................................8
3.0 Setting up and starting up .................................9
3.1 Overview .............................................................. 9
3.2 Setting up ............................................................10
3.2.1 Connection to the mains supply ..........................10
3.2.2 Microscope overview ..........................................10
3.2.3 Operating elements at the microscope ............... 11
3.2.4 Rear view of the control device
ATMOS
®
i View 21 PRO......................................11
3.2.5 Rear view of the control device of the
ATMOS
®
i View 31 PRO
(not with an integrated HD camera) .................... 11
3.2.6 Rear view of the control device of the ATMOS
®
i
View 31 PRO with an integrated HD camera .....12
3.3 Integration possibilities........................................12
3.4 Starting up...........................................................13
3.5 Operation requirements ......................................13
3.6 Starting up at a glance ........................................14
4.0 Operation ...........................................................15
4.1 Microscope suspension ......................................15
4.2 Mechanical arm...................................................15
4.3 Hand grips...........................................................15
4.3.1 T-hand grip ..........................................................15
4.3.2 Lateral double hand grip .....................................15
4.4 Adjusting the interocular distance .......................16
3
1.0 Introduction
1.1 Notes on Operating Instructions
These operating instructions contain important notes on how to operate the ATMOS® i View PRO safely,
correctly and effectively. Their reading helps to avoid risks, and also to reduce repair costs and downtimes. This increases, amongst other things, the reliability and service-life of the microscope.
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 PRO 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 PRO will be preserved.
• The product ATMOS
®
i View PRO bears CE marking CE according to the EC Directive of the council
for medical products 93/42/EEC and meets the basic requirements of Appendix 1 of this directive.
• The product ATMOS
®
i View PRO complies with all applicable requirements of the Directive 2011/65/
EU restricting the use of certain hazardous substances in electrical and electronic equipment
(„RoHS“).
• The declaration of conformity and our general standard terms and conditions can be obtained on our
website at www.atmosmed.com.
• The quality management system applied at ATMOS has been certied according to international
standards 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
®
i View 21 PRO ............................. REF 538.9000.0
Examination microscope with an integrated, fanless, high
transmission, high performance LED light source integrated in
the microscope head, 30° coupling included
ATMOS
®
i View 31 PRO ............................. REF 539.9000.0
Examination microscope with an integrated, fanless, high
transmission, high performance LED light source integrated in
the microscope head, 30° coupling included
4
1.2 Intended use
Name:
ATMOS
®
i View 21 PRO
ATMOS
®
i View 31 PRO
Main functions:
Optical instrument for magnication and illumination of the mouth to the pharynx, the auditory canal to the ear drum, the
middle ear and the nasal cavities. It can be used for observation and documentation as well as for the treatment of humans.
Medical indications / application:
Standard ENT examination for visual inspection in the eld of ENT and surgical interventions
Specication of the main function:
The application organ is illuminated for examination purposes and can be visualized on a monitor if desired by an integrated,
fanless high transmission, high performance LED light source, 5-step magnication changer, integrated camera module,
pivoting colour lter and an automatic light control via tilt sensor; the light output is min. 120 kLux (200 mm), min. 80 kLux
(250 mm), min. 55 kLux (300 mm), min. 30 kLux (400 mm) with a colour temperature of 5.500 K ± 10 %.
User prole:
Examinations and surgical interventions which are carried out using the microscope may only be performed by doctors with
appropriate training.
Only qualied personal with a proper hygiene training may prepare the microscope for surgical interventions.
Installation and maintenance may only be carried out by service technicians who were trained and authorised by the
manufacturer.
Patient groups:
No restrictions
Application organ:
Mouth to pharynx, auditory canal to the ear drum the middle ear and the nasal cavities
Application time:
Short term use on the patient (up to 30 days)
Application site:
Application sites are clinics, practices and operating rooms for ENT doctors and phoniatrists as well as temporal bone
laboratories. The examination with the microscope may only be executed by medically trained persons.
The microscope may only be used in closed rooms, on rm ground, wall-mounted, ceiling-mounted or mounted to ATMOS
ENT units.
In ORs an appropriate protective sleeve must be used.
Contraindications:
• No application in ophthalmology.
• Do not use the ATMOS
®
i View PRO on seated patients in combination with an objective (focal length of 200 mm to
300 mm).
The product is:
active
Sterility:
The microscope is not a 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
1.0 Introduction
1.3 Function
The ATMOS® i View PRO is a complete microscope system, consisting of optics and lighting. 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 tting options offer best working
quality.
The ergonomically assorted buttons, two selectable hand grips and the integrated control panel provides the user with highest
level of ergonomic comfort and suitability for daily use as well as an outstanding and intuitive handling. Via the control panel the
individual options of the ATMOS
®
i View PRO 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 automatic light control. Due to the variety of options which the ATMOS
®
i View PRO has to offer, the user is in a position to
congure 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 ne focussing or a VarioFocus 200-350 mm
(easy exchange of the lenses due to the respective thread on the microscope head)
• Binocular straight lens tube, binocular angled lens tube and binocular swivel tube, simple adaption due to the dove tail xation
(0° or 45° angled)
• Pivoting colour lter
• Measuring scale
• Shadowless illumination
Due to the LED light source and the integrable camera solution (SD or HD integrated respectively as HD or endoscope adapter for
the connection of an external camera) the ATMOS
®
i View PRO 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
PRO offers countless system possibilities, which can be individually adapted to suit the users environment!
These operating instructions describe all functions at maximum conguration of the ATMOS
®
i View 31 PRO.
6
1.4 Explanation of pictures and symbols
1.0 Introduction
!
■
●
Graphic symbols contained in these operating instructions
Warning, special diligent notice
Short cuts / symbols contained in these operating instructions
Please press where dot
indicates
Numeration
General information
Follow the arrows
Replace
Check
Please read,
important information
Move, plug... in this
direction
Engage, check
correct t
Turn, shift... in this
direction
Important information
Symbols ATMOS
®
i View PRO
SN Serial number
REF
Order number
Manufacturing date Manufacturer
Observe operating instructions! Observe operating instructions!
Weight adjustment for the carrier arm Professional disposal
Alternating current Fuse
2
Single use product - not for reuse.
Exchange after use.
This product complies with the relevant
requirements of EU Directives
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 transport.
Do not lean against the device.
Control panel ATMOS
®
i View 31 PRO
Light on / off (independent of automatic light
control)
Change between stroboscope - permanent light
With an integrated HD camera: Adjusting the light
mode of the camera
Video recording (start / stop) Freeze frame
click
7
1.0 Introduction
1.5 Scope of supply
• Prior to dispatch, the ATMOS® i View PRO 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).
1.6 Transport and storage
• After the transport of the ATMOS® i View PRO in
temperatures below 0°C or prior to rst start up it
should be kept at room temperature for at least six
hours. If the ATMOS
®
i View is not acclimatized it may
not be used as damages to the electronic components
could occur.
Only transport the device in a shipping carton, which is
padded and offers sufcient protection.
If damage occurs during transport:
• Document and report the transport damage.
• Send the device to ATMOS (Chapter „6.2 Sending in
the device“ on page 24).
Ambient 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 Protective cover
Microscope arm
Control device ATMOS® i View 21 PRO
Output of the power supply for the
electronics in the microscope
Potential equalisation acc. to IEC 604175021
Fuse
Control device ATMOS® i View 31 PRO
Fuse Potential equalisation acc. to IEC 604175021
Microscope Foot switch
Record function Freeze
Triggering signal from ATMOS® Strobo 21
LED
HD camera: not in use
Output signals of the tilt sensor in the carrier arm
system
USB port
Extern 2
Video In
Foot Switch
Out 1
Out 2 Out 3
Video Out
Intern 1
Video In
Input video signal Internal / External
(only with an integrated HD camera)
S-video-output
(not with an integrated HD camera)
Foot Switch
Out 1
Out 2 Out 3
Video Out
Output video signal
(only with an integrated HD camera)
8
2.0 For your safety
!
For your safety
mains power supply.
• Only proper and undamaged plugs and extension cables
may be used.
• To disconnect the ATMOS
®
i View PRO from the power
supply, the power cable must be removed from the wall
outlet. Only then can the connection cable from the
ATMOS
®
i View PRO be disconnected. Never touch plug
or line with wet hands.
• Please observe the ambient conditions stated in the
technical data (chapter 9.0).
• The ATMOS
®
i View PRO complies with the
electromagnetic immunity requirements of standard IEC
60601-1-2 / EN 60601-1-2 „Electromagnetic Compatibility Medical Electrical Devices“.
• 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.
• After a longer use of the ATMOS
®
i View PRO in
connection with an ear speculum the patient may feel
dizzy!
• With every light source a warming of tissue due to
absorption may occur. Please make sure to reduce
duration of use to a minimum, to switch off the light
source when not in use and to check heat development if
necessary.
• Take into consideration, 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.
• Risk of injury! Take care not to roll the mobile stand over
your feet when moving the stand.
• Please note that only PCs and monitors with IEC 6060101/EN 60601-1 approval may be connected to the video
outlet of the ATMOS
®
i View PRO supply module!
• During operation, the user is obliged to regularly check
the microscope for proper function. In the unlikely event
of failure the user must take precautions to continue the
treatment of the patient with suitable methods.
• Make sure that the unit is positioned so that all the controls
and the on/off switch are always accessible.
• To safely disconnect the unit from the mains, the power
cord must be removed from the IEC connector of the
control device!
• The ATMOS
®
i View PRO is a device designed in line with
IEC 60601-1-1/EN60601-1 and it is a device with protection
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
PRO. Defect cables must be replaced immediately.
• The ATMOS
®
i View PRO may only be operated by qualied
personnel.
• The ATMOS
®
i View PRO is not designed to be used
in an explosion-hazardous environment. Explosion-
hazardous areas may be caused by the use of ammable
anaesthetics, skin cleansing products and skin
disinfectants.
• The ATMOS
®
i View PRO may be operated only in rooms
used for medical purposes, but not in areas subject to
explosion hazards and in oxygen rich environments.
• If uids penetrated the ATMOS
®
i View PRO 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 PRO in
temperatures below 0°C or prior to rst start up it should
be kept at room temperature for at least six hours. If the
ATMOS
®
i View PRO is not acclimatised it may not be used.
• Do not plug in electric connections (plug, socket) under
the use of force. If this is not possible check whether the
plug ts the socket. If you should ascertain a defect in the
connection 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!
Never look directly into the light source!
> Damage to the eyes due to the strong glare.
• Please pay attention to the period tests in chapter 6
„Service and maintenance“ on page 24.
• Prior to every use the microscope suspension (all joints
included) need to be checked for safe connections.
• Take care that the patient does not touch the device or have
any contact with it.
• Please note that only the ATMOS
®
Strobo 21 LED may be
connected to the strobe port of the ATMOS
®
i View PRO!
• Please observe the EMC Directives. Failure to follow this
guideline can result in a hazard.
• Dispose of wrappings accordingly.
• Before connecting the ATMOS
i View PRO it needs to
be checked whether the requested mains voltage of the
ATMOS
®
i View PRO matches the mains voltage of the
9
3.0 Setting up and starting up
3.1 Overview
ATMOS® i View 21 PRO ATMOS® i View 31 PRO
Description
Examination microscope with an integrated,
fanless, high transmission, high performance
LED light in the microscope head
Examination microscope with an integrated,
fanless, high transmission, high performance
LED light in the microscope head
Integrated high
performance white
light LED
Automatic light
control
Optimised
stereo effect
Measuring scale optional optional
Integrated operating
panel
optional optional
Stroboscope mode - optional
Colour lter optional optional
Integrated camera -
optional SD camera or
optional HD camera
45° angled tube optional optional
Swivel tube 0-220° optional optional
Binocular rotary disk optional optional
HD adapter for an
external camera
- optional
Endoscope adapter - optional
Mains voltage 100–240 V 100–240 V
Light output
min. 120 kLux (200 mm)
min. 80 kLux (250mm)
min. 55 kLux (300 mm)
min. 30 kLux (400 mm)
min. 120 kLux (200 mm)
min. 80 kLux (250mm)
min. 55 kLux (300 mm)
min. 30 kLux (400 mm)
Operating life of the
LED
50,000 hours 50,000 hours
Colour temperature 5.500 K ± 10 % 5.500 K ± 10 %
Scope of delivery
Dust cover,
operating instructions
Dust cover,
operating instructions
10
3.0 Setting up and starting up
5-fold magnication changer
T-hand grip
(optional)
Binocular tube with wide
eld eyepiece lenses
Lens with ne focussing
(optional)
Pivoting colour lter
(optional)
Brightness control
Lateral double hand
grip (optional)
Control panel
(optional)
Endoscope adapter
(optional)
HD adapter for SONY
digital camera (optional)
Brake of the
coupling
Measuring scale
(optional)
3.2 Assembly
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 fullment of these requirements must be conrmed by an
authorized expert.
Mains voltage and fuse: Mains voltage: 100-240 V; 50/ 60 Hz, fuse: 2 x T 3.15 A
Please note that only PCs and monitors with IEC 606010-1/EN 60601-1 approval may be connected to the video outlet of the
ATMOS
®
i View PRO supply module!
Please note that only the ATMOS
®
Strobo 21 LED may be connected to the strobe port of the ATMOS® i View PRO!
3.2.1 Connection to the mains supply
Potential equalisation:
The ATMOS
®
i View 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 user/patient safety can be increased especially in the case of a defective earth
conductor. For connecting the device's potential equalisation plug with the potential equalisation rail of the room, use the potential
equalisation cord with REF 530.0030.0.
3.2.2 Microscope overview
!
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