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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Internet Address: http://www.LEISEGANG.de 3
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

LEISEGANG
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

LEISEGANG
Internet Address: http://www.LEISEGANG.de 7
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

LEISEGANG
Internet Address: http://www.LEISEGANG.de 9
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,