Atmos i View 21 COLPO, i View 31 COLPO Operating Instructions Manual
English
ATMOS® i View
COLPO
Operating Instructions
GA1GB.420101.0
2018-04 Index 24
Table of contents
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 colposcope ...............11
3.2.4 Rear view of the control device of the
ATMOS
3.2.5 Rear view of the control device of the
ATMOS
(not with an integrated HD camera) .................... 11
3.2.6 Rear view of the control device of the ATMOS
View 31 COLPO 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
®
i View 21 COLPO ................................. 11
®
i View 31 COLPO
®
i
4.0 Operation ...........................................................15
4.1 Colposcope 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
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 Pivoting green lter .............................................18
4.13 Pivoting H.A.S.I. lter ..........................................19
4.14 Shadowless illumination......................................19
4.15 Colposcope 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 Basic instructions ................................................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
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.de
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
2
1.0 Introduction
1.1 Notes on Operating Instructions
These operating instructions contain important notes on how to operate the ATMOS® i View COLPO 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 colposcope.
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 colposcope.
Care and safety inspections in conjunction with professional execution provide for operational safety and
readiness for use of your ATMOS
®
i View COLPO 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
• The product ATMOS
®
i View COLPO will be preserved.
®
i View COLPO 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 I of the directive.
®
• The product ATMOS
i View COLPO complies with all applicable requirements of the Directive 2011/65/
EC restricting the use of certain hazardous substances in electrical and electronic equipment (“RoHS”).
• The declaration of conformity and our general standard terms and conditions can be obtained on our
website at 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.
These operating instructions are valid for the following
devices:
®
ATMOS
i View 21 COLPO .........................REF 605.0000.0
Colposcope with an integrated, fanless, high transmission,
high performance LED light in the colposcope head
®
ATMOS
i View 31 COLPO .........................REF 606.0000.0
Colposcope with an integrated, fanless, high transmission,
high performance LED light in the colposcope head
Please keep this document for future consultation!
3
1.0 Introduction
1.2 Intended use
Name: ATMOS® i View 21 COLPO
®
ATMOS
Main functions: Visualization of natural body orices (genital area) for examinatory purposes
i View 31 COLPO
Medical indications /
application:
Specication of the main
function:
User prole: Examinations and surgical interventions which are carried out using the
Patient groups: No restrictions
Application organ: Natural orices (portio and vulva)
Application time: Short-term, under normal conditions for permanent use over a maximum up to
Application site: Application sites are hospitals, doctor’s ofces, ORs at gynaecologists. The
Standard gynaecological examinations. Visual control of the genital area.
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 fold magnication changer, integrated
camera module, pivoting green lter and an automatic light control via tilt
sensor; the light output is min. 120 kLux (200 mm)with a colour temperature of
5.500 K ± 10%.
colposcope may only be performed by doctors with appropriate training.
Only qualied personal with a proper hygiene training may prepare the
colposcope for surgical interventions.
Installation and maintenance may only be carried out by service technicians
who were trained and authorised by the manufacturer.
30 days
examination with the colposcope may only be executed by medically trained
persons.
The colposcope may only be used in closed rooms, on rm ground or mounted
to the ATMOS
In ORs an appropriate protective sleeve must be used.
®
Chair 41 Gyne .
Contraindications: • No application in ophthalmology.
The product is: active
Sterility: The colposcope is not a sterile product.
Single-use product /
reprocessing:
The colposcope is intended for multiple use. The device and parts of the
accessories are reusable. For information on reprocessing, cleaning and
disinfection please see the operating instructions.
4
1.0 Introduction
1.3 Function
The ATMOS® i View COLPO is a complete colposcope 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
/ 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
position to congure a colposcope 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 colposcope head)
• 5 fold magnication changer. Exact adjustments due to turning disks on both sides.
• Binocular tubes, simple adaption due to the Zeiss dove tail.
• Pivoting colour lter
• Measuring scale
• Shadowless illumination
®
i View COLPO can be activated. Besides the triggering of the camera (freeze frame) and starting
®
i View COLPO has to offer, the user is in a
Due to the LED light source and the integrable camera solution (SD integrated respectively as HD or endoscope adapter for the
connection of an external camera) the ATMOS
In connection with the mechanical support arm and the numerous connection possibilities to units and stands the ATMOS
®
i View COLPO is a guarantor for best image quality.
®
i View
COLPO offers countless system possibilities, which can be individually adapted to suit the users environment!
®
These operating instructions describe all functions with a maximum conguration of the ATMOS
i View 31 COLPO.
5
1.0 Introduction
1.4 Explanation of pictures and symbols
Short cuts / symbols contained in these operating instructions
Follow the arrows
■
General information
Move, plug... in this
direction
Please press where
dot indicates
Please read,
important information
Graphic symbols contained in these operating instructions
Warning, special diligent notice
●
Numeration
Check
!
Symbols ATMOS
SN Serial number
®
i View
Manufacturing date Manufacturer
Observe operating instructions! Observe operating instructions!
REF
click
) Important information
Order number
Turn, shift... in this
direction
Replace
Engage, check
correct t
Weight adjustment for the carrier arm Professional disposal
Alternating current Fuse
2
Control panel buttons
Single use product - not for reuse.
Exchange after use.
Do not look directly into the light source of
the ATMOS
Light on / off (independent of automatic light
control)
Video recording (start / stop)
®
i View COLPO.
This product complies with the relevant
requirements of EU Directives
Sitting is prohibited.
Freeze frame
With an integrated HD camera: Adjusting the light
mode of the camera
6
1.0 Introduction
Foot Switch
Out 1
Out 2 Out 3
Video Out
Foot Switch
Only ATMOS® i View 21 COLPO
Output of the power supply for the electronics in the colposcope
Fuse
®
Only ATMOS
i View 31 COLPO
Fuse Potential equalisation acc. to IEC 604175021
Colposcope Foot switch
Record function Freeze
Potential equalisation acc. to IEC 604175021
not in use
USB port
S-video-output (not with an integrated HD
camera)
Video In
Intern 1
Out 1
Video Out
Out 2 Out 3
Output signals of the tilt sensor in the carrier arm
system
Video In
Extern 2
Input video signal internal / external (Only with an
integrated HD camera)
Output video signal
(Only with an integrated HD camera)
1.5 Scope of supply
• Prior to dispatch, the ATMOS® i View COLPO 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).
Colposcope
Operating
Instructions
Colposcope arm
Protective cover
1.6 Transport and storage
• After the transport of the ATMOS® i View 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
acclimatized it may not be used as damages to the
electronic components may be the result.
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).
®
i View COLPO is not
Ambient conditions:
• Transport / storage:
-10...+50 °C;
30...95 % humidity without condensing
air pressure 500...1060 hPa
• Operation:
+10...+35 °C;
30...95 % humidity without condensing
air pressure 700...1060 hPa
7
2.0 For your safety
!
For your safety
• To safely disconnect the unit from the mains, the power
cord must be removed from the IEC connector of the
control device!
®
• The ATMOS
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
COLPO. Damaged cables must be replaced immediately.
• The ATMOS
qualied personnel.
• The ATMOS
in an explosion-hazardous environment. Explosion-
hazardous areas may be caused by the use of ammable
anaesthetics, skin cleansing products and skin
disinfectants.
• If uids penetrated the ATMOS
be sent in and may only be used after the check up of an
ATMOS authorised person.
• After the transport of the ATMOS
below 0°C or prior to rst start up it should be kept at room
temperature for at least six hours. If the ATMOS
COLPO 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 colposcope 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 observe the EMC Directives. Failure to follow this
guideline can result in a hazard.
• Make sure that the unit is positioned so that all the controls
and the on/off switch are always accessible.
• Dispose of wrappings accordingly.
• Before connecting the ATMOS
be checked whether the requested mains voltage of the
ATMOS
mains power supply.
• Only proper and undamaged plugs and extension cables
may be used.
i View COLPO is a device designed in line
®
i View
®
i View COLPO may only be operated by
®
i View COLPO is not designed to be used
®
i View COLPO it needs to
®
i View in temperatures
®
i View
®
i View COLPO it needs to
®
i View COLPO matches the mains voltage of the
• To disconnect the ATMOS
mains supply, rst remove the plug from the wall outlet.
Disconnect the connection line on the ATMOS
®
i View COLPO from the
®
i View
COLPO afterwards only. 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 COLPO meets the immunity to
interference requirements of IEC 60601-1-2 / EN 606011-2 „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.
• 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.
®
• The ATMOS
i View COLPO may be operated only
in rooms used for medical purposes, but not in areas
subject to explosion hazards and in oxygen rich
environments.
• Take into consideration, when setting up the colposcope,
that the elastic force of the arm – without colposcope
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 COLPO supply module!
• 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.
8
3.0 Setting up and starting up
3.1 Overview
ATMOS® i View 21 COLPO ATMOS® i View 31 COLPO
Examination colposcope with an inte-
Description
Integrated high
performance white
light LED
Automatic light
control
Optimised stereo
effect
Measuring scale Optional Optional
Integrated operating
panel
Colour lter Optional
Integrated camera -
HD adapter for an
external camera
Endoscope adapter - Optional
Mains voltage 100–240 V 100–240 V
grated, fanless, high transmission, high
performance LED light in the colposcope
head
Optional Optional
- Optional
Examination colposcope with an integrated, fanless, high transmission, high
performance LED light in the colposcope
head
Optional green lter or
Optional H.A.S.I. lter
Optional SD camera or
Optional HD camera
min. 120 kLux (200 mm)
Light output
Operating life of the
LED
Colour temperature 5.500 K ± 10 % 5.500 K ± 10 %
Scope of delivery
min. 80 kLux (250mm)
min. 55 kLux (300 mm)
min. 30 kLux (400 mm)
50 000 hours 50 000 hours
Dust cover,
operating instructions
min. 120 kLux (200 mm)
min. 80 kLux (250mm)
min. 55 kLux (300 mm)
min. 30 kLux (400 mm)
Dust cover,
operating instructions
9
3.0 Setting up and starting up
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
3.2.1 Connection to the mains supply
Potential equalisation:
The ATMOS
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
®
i View COLPO supply module!
®
i View COLPO supply module has a rear connection for potential equalisation which can be connected to the
Wide eld eye
piece lenses with
binocular tube
Rotating disk 5
fold magnication
changer
Lens
Lateral double hand
grip (optional)
T-hand grip
(optional)
Pivoting colour lter
(optional)
Measuring scale
(optional)
Brightness control
HD adapter for SONY
digital camera (optional)
Control panel
(optional)
10
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