Leisegang 1E light User manual

Installation and Operating Instructions
for
L E I S E G A N G
Colposcopes and Accessories
All rights reserved. No part of this work may be reproduced in any
form (printing, photocopy, microfiche or in other processes) without
written permission from LEISEGANG Feinmechanik-Optik GmbH, or
processed, duplicated or distributed with electronic systems.
Edition February 2007

Colposcopes from
2 LEISEGANG Feinmechanik*Optik GmbH, Leibnizstrasse 32, D-10625 Berlin, GERMANY
Phone [phone] – 0 * Fax: [phone] * www.LEISEGANG.de
TABLE OF CONTENTS
1. Important general references ________________________________________________________________6
1.1 Preliminary notes _______________________________________________________________________6
1.2 Determination-Appropriate Use ___________________________________________________________6
1.2.1 Indications for use____________________________________________________________________7
1.2.2 Contra - Indications for use ____________________________________________________________7
1.3 How to read this operating instructions _____________________________________________________9
2. Important Notes on Safety (PLEASE READ THESE CHAPTER URGENTLY FIRST) __________________10
2.1 List of Warnings _______________________________________________________________________10
3. Certifications ______________________________________________________________________________12
3.1 CE Certification _______________________________________________________________________12
3.2 UL Certification _______________________________________________________________________12
3.3 Quality management ___________________________________________________________________12
3.3.1 EN ISO 13485 / 07.2003______________________________________________________________13
4. Short Product Overview______________________________________________________________________14
5. Guarantee_________________________________________________________________________________16
6. Colposcopes _______________________________________________________________________________18
6.1 Equipment overview, installation and operation _____________________________________________18
6.2 Scope of delivery and testing of the supplied goods___________________________________________18
6.3 Model 1E light & 1D light _______________________________________________________________19
6.3.1 Hold adjustment for inclining__________________________________________________________19
6.4 Model 1 & 1D & 1DF & 1DFW___________________________________________________________20
6.4.1 Installation of Fiber Optics for F-Models_________________________________________________21
6.5 Model 3MV & 3ML & 3MLF & 3DLF_____________________________________________________22
6.5.1 Camera adaptation __________________________________________________________________24
6.5.2 Installation of Fiber Optics for F-Models_________________________________________________25
6.6 General Adjustments ___________________________________________________________________26
6.6.1 Rough height adjustment _____________________________________________________________26
6.6.2 Vertical & Horizontal fine adjustment ___________________________________________________26
6.6.3 Compensation of ametropia ___________________________________________________________27
6.6.3.1 Regular view (without glasses)______________________________________________________27
6.6.3.2 Colposcopic operation with glasses __________________________________________________27
6.6.3.3 Colposcopic operation without glasses________________________________________________27
6.6.3.4 Ocular adjustment________________________________________________________________27
6.6.4 Magnification Changer_______________________________________________________________28
6.6.5 Green filter ________________________________________________________________________28
6.7 Help Yourself _________________________________________________________________________29
6.7.1 Fine height adjustment _______________________________________________________________29
6.7.2 Hold adjustment for inclining__________________________________________________________30
6.7.3 Lamp change_______________________________________________________________________30
6.7.3.1 Inbuilt 20 W halogen lamp ____________________________________________________________30
6.7.3.2 Coldlight 75 W halogen lamp__________________________________________________________30
6.7.4 Fuses_____________________________________________________________________________31

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7. Stands____________________________________________________________________________________32
7.1 Swing Stand___________________________________________________________________________33
7.1.1 Installation of Swing Stand____________________________________________________________33
7.1.2 Dimensions________________________________________________________________________34
7.2 The Balance-o-Matic Stand ______________________________________________________________35
7.2.1 Installation of Balance-o-Matic Stand ___________________________________________________35
7.2.2 Dimensions________________________________________________________________________36
7.3 Tilt-o-Matic Stand & light 5-wheel spider base (upright Stand) ________________________________37
7.4 Installations___________________________________________________________________________38
7.4.1 Installation of Swing Stand on mobile 5-wheel spider base ___________________________________38
7.4.2 The Balance-o-Matic Stand on mobile 5-wheel spider base___________________________________39
7.4.3 Fixed attachment onto the gynecological examination chair __________________________________40
8. Illumination Units __________________________________________________________________________43
8.1 30W Power Supply Unit_________________________________________________________________43
8.2 Fiber Optic Projector (Cold Light Illumination Unit)_________________________________________44
8.2.1 Connect Fiber Cable ____________________________________________________________________46
8.3 LED-Lighting _________________________________________________________________________46
9. Accessories________________________________________________________________________________47
9.1 Video Adapters ________________________________________________________________________48
9.1.1 Mounting Video Adapters ________________________________________________________________49
9.2 Cameras______________________________________________________________________________50
9.3 Micromanipulator______________________________________________________________________51
10. Care and maintenance_____________________________________________________________________53
10.1 Colposcope head _______________________________________________________________________53
10.2 Stands________________________________________________________________________________53
10.3 Accessories and external devices__________________________________________________________53
11. Replacement wear parts and technical service __________________________________________________54
11.1 Technical service_______________________________________________________________________54
11.2 Spare and wear parts ___________________________________________________________________54
11.2.1 Lamp change_______________________________________________________________________55
11.2.1 Fuses_____________________________________________________________________________55
12. Technical data and notes on safety___________________________________________________________56
12.1 EMC - Electromagnetic compatibility _____________________________________________________56
12.2 Control and maintenance________________________________________________________________56
12.3 Returns, complaints ____________________________________________________________________56
13. Technical Data___________________________________________________________________________57
13.1 Type plates____________________________________________________________________________57
13.1.1 Colposcope head____________________________________________________________________57
13.1.2 30W Power Supply (Illumination Unit) __________________________________________________57
13.1.3 Fiber Optic Projector ________________________________________________________________57
13.1.4 LED Power Supply__________________________________________________________________58
13.1.5 Video Adapter______________________________________________________________________58
13.2 Classification__________________________________________________________________________58
13.3 Safety Class ___________________________________________________________________________58

Colposcopes from
4 LEISEGANG Feinmechanik*Optik GmbH, Leibnizstrasse 32, D-10625 Berlin, GERMANY
Phone [phone] – 0 * Fax: [phone] * www.LEISEGANG.de
13.4 Environment Conditions ________________________________________________________________59
13.5 Dimensions and weights (all information approx.) ___________________________________________59
13.6 Electrical connections___________________________________________________________________59
13.7 Power Consumption ____________________________________________________________________59
13.8 Fuses_________________________________________________________________________________59
13.9 Lamps _______________________________________________________________________________60

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Internet Address: http://www.LEISEGANG.de 5
Objective Determination
Colposcopes are employed in gynecological examinations for the magnified, contactless
examination of the external feminine genital organ (vulva, vagina, portio).
However, they can also be employed for magnified, contactless examination of other
external organs.
In the case of colposcopes, there is the possibility to connect photographic recorders -
according to features and model - for evaluation and subsequent documentation.
Colposcopes are used exclusively for diagnostic purposes and thus correspond to §3,
Para. 1 of the MPG, in accordance with the requirements on a medical product.
So that you become completely acquainted with the functionality and operation of your
colposcope and become familiar with the system, we recommend you to read these
directions for use carefully before the first use of your device.
In case of any questions, we are glad to remain available for you at any time:
LEISEGANG Feinmechanik-Optik GmbH
Leibnizstraße 32
D - 10625 Berlin
GERMANY
Phone: + 49 (0) 30 / 319009-0
Fax: + 49 (0) 30 / 313 5992
e-mail: [email protected]
Internet: http://www.LEISEGANG.de

Colposcopes from
6 LEISEGANG Feinmechanik*Optik GmbH, Leibnizstrasse 32, D-10625 Berlin, GERMANY
Phone [phone] – 0 * Fax: [phone] * www.LEISEGANG.de
1. Important general references
1.1 Preliminary notes
With the purchase of a LEISEGANG colposcope, you have decided on an advanced product which
was developed and has been continuously improved in cooperation with practicing gynecologists,
in order to become better adapted to the requirements of modern treatment technology.
Experience, precision and continuous manufacturing optimization, has enabled LEISEGANG
Feinmechanik-Optik GmbH to become the leading manufacturer of colposcopic precision
instruments, with the largest product range of colposcopes in the world.
1.2 Determination-Appropriate Use
Colposcopes and their accessories may be employed only for gynecological
examinations and for the magnified viewing of organs, which are visible and
accessible, without direct patient contact from outside.
They may be employed only with the mounts, sources of light, flash equipment and
accessories, provided for this purpose by the LEISEGANG Company.
The restrictions, which are stipulated in the directions for use, are to be considered.
The device is designed for application in medical practices and/or clinics and for the
environmental conditions prevailing there.
According to the stipulations of the MPG, colposcopes may be operated only by
those persons who have been instructed in the expert handling of the device.
The proper installation and maintenance of the device are absolutely vital
prerequisites for the use of the colposcope.
The user has to check the
functional-stability and proper condition
of the device before every application

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1.2.1 Indications for use
A colposcope may be helpful in the following situations.
1. Major abnormality on pap smear.
2. Persistent minimal abnormality on pap smear..
3. Abnormalities of squamous or columnar cells..
4. Persistence of an inflammatory appearance of the smear despite adequate treatment..
5. Presence of keratinised cells suggestive of leukoplasia.
6. Symptoms of metrorrhagia, in particular contact bleeding..
7. Abnormal appearance of cervix or vagina by naked-eye examination.
8. Monitoring after treatment of dysplasia, regardless of treatment method..
9. Evaluation after exposure to diethylstilbestrol (DES) or related drugs during embryogenesis.
10. Evaluation of anogenital condylomatosis.
11. Evaluation of vulvo-perineal bowenoid papulosis.
12. Preoperative evaluation before genital-traGt surgery: hysterectomy, treatment of genital
prolapse, cervicovaginal plastic surgery, ete.
13. Lesion noted on routine gynecologic examination.
1.2.2 Contra - Indications for use
The colposcope is a device for viewing the body from a distance and is not intended for patient
contact.. Because of this there are no contraindications for use of a colposcope.

Colposcopes from
Symbols
Caution!
!
Reference
Installation
8 LEISEGANG Feinmechanik*Optik GmbH, Leibnizstrasse 32, D-10625 Berlin, GERMANY
Phone [phone] – 0 * Fax: [phone] * www.LEISEGANG.de

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1.3 How to read this operating instructions
These have the objective of explaining the structure and the operating mode of the colposcope in
several stages, to make understandable and technically feasible the installation of the individual
subassemblies, up to the finished system, as well as to put the users into the situation where they
are able to eliminate small faults themselves, since the technical interdependencies are
understood.
The subdivision of these instructions corresponds to the structure of a colposcope. First the head,
then the mount, then accessories, electrics, maintenance and safety are reviewed. In order to
facilitate their reading and understanding for you, we have structured the page so that the drawings
always appear on the left double page and the text always appears on the right.
The inside edge of the right-hand page is exclusively reserved for important key words (cf. key
word register at the end), symbols and provides sufficient space for your personal remarks, in order
to rapidly find (again) particularly important points.
The meaning of the symbols is as follows:
!
Caution: Please make absolutely sure that you consider the information and details provided at
this location, in order to avoid damage to persons and to the device.
References: Here, reference is made to certain behavior and procedures during the installation
and adjustment of the device or individual device subassemblies, such as the change of light
intensities, filter insertions, fuse replacement and similar.
Installation: The delivery of the goods dispatched from LEISEGANG Feinmechanik-Optik GmbH
always includes the tools needed for the installation, such as screwdrivers, Allen keys and similar.

Colposcopes from
!
2. Important Notes on Safety (PLEASE READ THESE CHAPTER URGENTLY FIRST)
Before you start operation of the colposcope into, please make yourself familiar with the following
safety regulations and consider these during the entire period of employment of the device:
2.1 List of Warnings
1. The colposcope is equipped with a safety mains cable and may be connected exclusively to
a protective grounded plug socket only.
2. Do not employ any extension cords.
3. Never adjust or cover over the transformers or other subassemblies. This can lead to
overheating and damage to the device.
4. The power supply units for the illumination lamp and flash light generator should be
switched on for safety reasons only for 10 minutes per hour. A device switched on durably
can be overheated in certain situations.
5. Employ exclusively those mounts which have been provided to you, together with the
LEISEGANG colposcope or have been manufactured by LEISEGANG Feinmechanik-Optik
GmbH.
6. Do not hang any additional objects on the colposcope or on parts of the mount which are
not explicitly planned for that.
7. Do not lean on the device.
8. Do not operate the device in an explosive-endangered environment.
9. Defective cables or plugs are the causes of electrical accidents and fires. Renew defective
cables immediately or call an authorized technician.
10. Power supply units with damaged cases are not allowed to be used any longer. They must
be exchanged by LEISEGANG immediately
11. The mains cable may never be removed at the cable connection end but always at the plug
socket only.
10 LEISEGANG Feinmechanik*Optik GmbH, Leibnizstrasse 32, D-10625 Berlin, GERMANY
Phone [phone] – 0 * Fax: [phone] * www.LEISEGANG.de
12. Before connecting the power supply to the device, it must be checked whether the mains
voltage and frequency agree with the information on the label.
13. Do not roll the device over deep-pile carpets or over objects which are on the floor (cables,

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hoses).
14. Never set up or operate the device on rough or tilted surfaces.
15. Except for the components described in these directions for use, the device may be opened
16. LEISEGANG isn't liable for damages resulting from improper use of their products or
17. Disposal: Devices produced by LEISEGANG and defective parts as well must be disposed
exclusively by LEISEGANG-trained personnel only, since high-voltage live parts are present
in the device or in the subassemblies.
contraventions against safety notes mentioned above.
professionally only according to the valid laws and standards in the operator’s country.

Colposcopes from
3. Certifications
3.1 CE Certification
The device is tested according to the specifications of the European Directive 93/42/EWG, dated
14th June 1993, and fulfills the necessary standards concerning the MPG Medical Products Law. All
devices, which are manufactured by LEISEGANG Feinmechanik-Optik GmbH, belong to Class 1 of
non-invasive products, according to Appendix IX of EU Guideline 93/42/EWG. The colposcopes
are checked for compliance with the basic requirements according to Appendix I of Guideline 93/42
EWG and are provided with the CE mark which indicates agreement with the legal stipulations.
A declaration of conformity from LEISEGANG Feinmechanik-Optik GmbH, as well as full test
documentation and protocols, are available on request.
3.2 UL Certification
XXXX
LEISEGANG colposcopes model 1DS, 3MS, 3MLS
WITH RESPECT TO ELECTRIC SHOCK
FIRE, AND MECHANICAL HAZARDS ONLY
IN ACCORDANCE WITH UL 60601-1
LEISEGANG colposcopes and colposcopic accessories are certificated according to the strict US-
American market laws for medical devices. LEISEGANG products meet the requirements of UL
60601-1. They are labeled with UL mark.
3.3 Quality management
LEISEGANG Feinmechanik-Optik GmbH company has been established a quality management
system according to ISO 9001 since 1995, upgaded to ISO 13485 in January 2004. Regular
internal auditing is the key for continuous improvements. Monitoring by authorized external auditors
guarantees the agreement with the respective international standards.
During the whole manufacturing process LEISEGANG products are subjected to production
accompanying quality controls.
LEISEGANG Feinmechanik-Optik GmbH
Leibnizstrasse 32, Berlin D-10625, GERMANY
Phone: + 49 (0) 30-319 009 0, Fax: + 49 (0) 30-313 599 2
Internet: http://www.LEISEGANG.de
e-mail: [email protected]
12 LEISEGANG Feinmechanik*Optik GmbH, Leibnizstrasse 32, D-10625 Berlin, GERMANY
Phone [phone] – 0 * Fax: [phone] * www.LEISEGANG.de

LEISEGANG
Internet Address: http://www.LEISEGANG.de 13
3.3.1 EN ISO 13485 / 07.2003

Colposcopes from
4. Short Product Overview
In the description of the different colposcope model series and types, certain terms and technical
solutions are addressed, which, in part, are available from LEISEGANG as the only worldwide
provider. In order that, during the consideration of later models, cross references and return
references to other sections do not interrupt the continuous flow of reading, a few terms are
explained at this point.
•Optimal treatment success depends directly on optimum examination results. It is vital that
the colposcope supplies a three dimensional image, which represents, as best as possible,
the protrusions, depressions and blood vessels on the subject of examination. All
LEISEGANG colposcopes, from Model Series 1 to 3, have the same quality optics and all
offer stereoscopic viewing.
•Each of the two eyepieces can be optimally adapted to the individual eye and possible
defective visions can be corrected with a compensation for ametropia (defective vision)
from +7 to -7, so that the operator can work with and without viewing aids.
•Convergent viewing beam paths correspond
to the natural viewpoint and - in contrast to
parallel mode - focus very exactly on one
predefined point (see diagram). The individual
images of both eyes are placed over each other
and automatically supply a spatial image, while
instruments, which work in microscopic mode,
always presuppose a short adaptation phase for
the eyes, in order to provide convergence of the
parallel individual images for a spatial viewpoint.
With an average processing number of 20 - 40
colposcopic examinations per day, the selection
of the correct examination device is a very
important decision, also from the point of view of
ergonomics to avoid tiring activities at work.
Optical Beam Path
Convergent Unaided Eye Parallel
•If colposcope heads and colposcopes are referred to in the following text, then the term
colposcope head always means only the actual examination instrument, while the
colposcope describes the entire basic device with all accessories, from the mount, through
the power and light source, up to the mains cable.
14 LEISEGANG Feinmechanik*Optik GmbH, Leibnizstrasse 32, D-10625 Berlin, GERMANY
Phone [phone] – 0 * Fax: [phone] * www.LEISEGANG.de
•LEISEGANG colposcope heads are further distinguished according to model series and
type. In total, 3 different series, with various model types, exist for the most varied of tasks.
For unambiguous identification, every device head bears a punched five-digit serial number,
as well as type identification. The identification begins with a digit and, according to
colposcope type, up to four more alphabetic characters. Every alphabetic character has its

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own meaning, which provides information about the features of the colposcope
head. Differentiation is as follows:
D= Rotary drum change-over for observation magnification
M= 7.5/15/30x magnification, also for photography
V= Video colposcope with integrated camera
L= Photo colposcope, without electronic flash
W= Convenient 45° inclined optics
F= Fiberglass / Cold light source
•The colposcopes of the Series D and M are equipped with a rotary changeover for three
magnification stages. The scales with the magnification change are 1:2 in each case and
basically result in another, unmistakable image. In detail, the following magnifications are
available: 7.5/15/30x or 3.75/7.5/15x.
•In the case of the photo colposcopes of the Series M, three magnifications are also
available for photography: 7.5/15/30x.

Colposcopes from
16 LEISEGANG Feinmechanik*Optik GmbH, Leibnizstrasse 32, D-10625 Berlin, GERMANY
Phone [phone] – 0 * Fax: [phone] * www.LEISEGANG.de
5. Guarantee
Provided that nothing else has been agreed on in writing, LEISEGANG Feinmechanik-Optik GmbH
gives a guarantee of freedom from defects, corresponding to the respective state of the art and the
device type or subassembly, for the devices manufactured by it in the Berlin factory, for a duration
of 2 years from delivery date, to the first user.
Excluded from this are exposure, power and light-guide cables, lamps, fuses and other
consumption materials. However, LEISEGANG Feinmechanik-Optik GmbH guarantees the full
functionality capability of these on delivery.
If, in spite of quality control at the factory, faults occur on the device or subassemblies, this must be
communicated immediately by the customer after their discovery to LEISEGANG Feinmechanik-
Optik GmbH in writing and/or a complaint immediately made to the carrier about transport
packaging damage.
LEISEGANG Feinmechanik-Optik GmbH will carry out repairs immediately, according to the
technical requirements, by means of replacement or repair of faulty parts, without consideration of
the costs that are necessary for the purposes of repair at a later stage.
A claim to replacement delivery does not exist.
The guarantee does not include the removal of damages, which have arisen due to
•A fault not indicated by the customer or
•The customer has not given the chance for the repair to be carried out immediately after
request or
•The device or subassemblies have been handled incorrectly or
•The device or subassemblies have been repaired by third parties without explicit written
permission from LEISEGANG Feinmechanik-Optik GmbH,
•Repair experiments have been undertaken or
•Care and maintenance operations were not carried out or
•The customer has not followed the specifications concerning the handling, maintenance and
care of the device or the subassemblies, in accordance with the directions for use.
LEISEGANG Feinmechanik-Optik GmbH can provide no guarantee for faults, which have arisen
through inappropriate treatment of the device or subassemblies, as well as for consequential
damage to the device or subassemblies that has occurred due to faults in the electricity at the
operation location and similar circumstances which have occurred in the area of the device user.
If other parts are added or connected to the device or subassemblies, without written consent from
LEISEGANG Feinmechanik-Optik GmbH, or parts are removed, then the guarantee is rendered
invalid with instant effect. This applies also in the case of removal of the serial number or the type
plate, incorrect handling or willful destruction.
Natural wear on movable articulated links, springs, pull-out parts, painted surfaces and similar, are
excluded from the guarantee.

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The guarantee for
LEISEGANG colposcopes
is 2 years.
We hold spareparts
for 10 years

Colposcopes from
18 LEISEGANG Feinmechanik*Optik GmbH, Leibnizstrasse 32, D-10625 Berlin, GERMANY
Phone [phone] – 0 * Fax: [phone] * www.LEISEGANG.de
6. Colposcopes
6.1 Equipment overview, installation and operation
At this point begins the directions for the actual use and installation of your device. Please first
check for damage the outside of the transport packaging, and then the devices or subassemblies
supplied.
The following chapters give a step by step account of the relevant testing, installation, operation
and security references, as well as the correct locations to which you can refer if reason for
complaint exists.
If, at this point, obvious defects should exist already, please immediately refer to your dealer or to
LEISEGANG Feinmechanik-Optik GmbH, under the numbers indicated below.
6.2 Scope of delivery and testing of the supplied goods
The scope of delivery of a complete LEISEGANG colposcope basically always includes at least the
following four different items:
1. The colposcope head
2. The mount with special part set (special installation equipment etc.) for the fixed attachment
to the examination chair (B) or to a 5-wheel spiderbase (A);
3. The power and light source, i.e. transformer or cold light projector;
4. The accessories, i.e. cables, spare lamps, tools, fitting instructions etc.
Possibly associated with the scope of delivery:
5. Additional appliances, such as photographic and video cameras, adapters and external
devices such as monitors, computer etc.
This 5-item sub-division corresponds roughly to the structure of these Installation and Operating
Instructions. Please note, however, during the assembling of the device or devices, that the mount
is always assembled first, then the power and light source and finally the colposcope head with
accessories.

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6.3 Model 1E light & 1D light
The colposcopes of light series are standard colposcopes with restricted features in handling. All
optical features are the same as colposcopes with higher performance.
Model 1D light Model 1E light
These standard colposcopes fulfill the basic requirements of lots practicing gynecologist. Clear
functions, ergonomic handling and the preparation for the possibility of later retrofitting of imaging
systems and micromanipulators for laser applications (available only through laser manufacturer),
characterize this series. Against all other LEISEGANG colposcopes the light models have no
horizontal and vertical fine adjustment. Only the inclining function is given.
Model 1D light consists against Model 1E light over a three magnification (7.5x/15x/30x) drum
changer. Both models have compensation of ametropia and green filter.
6.3.1 Hold adjustment for inclining
If the colposcope will not hold the inclining position you
have to adjust the inclining hold force with this screw.

Colposcopes from
6.4 Model 1 & 1D & 1DF & 1DFW
The Colposcopes of Model 1D series includes LEISEGANG popular standard colposcopes with
precision fine adjustments in horizontal and vertical direction, green filter and high performed
optics.
Model 1 Model 1D Model 1DF Model 1DFW
FEATURES
Model 1
•15x standard magnification
•Inbuilt 12V/20W halogen lamp
Model 1D
•3 magnifications drum changer (7.5x/15x/30x). S-version with 3.75x/7.5x/15x
•Inbuilt 12V/20W halogen lamp
Model 1DF
•3 magnifications drum changer (7.5x/15x/30x). S-version with 3.75x/7.5x/15x
•External high illumination cold light12V/75W halogen lamp connected to colposcope by fiber
optic cable
Model 1DFW
•3 magnifications drum changer (7.5x/15x/30x). S-version is not available
•External high illumination cold light12V/75W halogen lamp connected to colposcope by fiber
optic cable
•Comfortable 45° inclined ocular optics
20 LEISEGANG Feinmechanik*Optik GmbH, Leibnizstrasse 32, D-10625 Berlin, GERMANY
Phone [phone] – 0 * Fax: [phone] * www.LEISEGANG.de