LISEGANG Kolposkop - DFU

Instruction Manual
for
LEISEGANG® Colposcopes
and Accessories
All rights reserved. No part of this work may be reproduced in any form without written permission from
CooperSurgical, Inc.
35348 Rev C. 4/08

Colposcopes from
TABLE OF CONTENTS
1. Important general references __________________________________________________________________ 5

1.1 Preliminary notes _________________________________________________________________________ 5
1.2 Determination-Appropriate Use _____________________________________________________________ 5
1.2.1 Indications for use______________________________________________________________________ 5
1.2.2 Contraindications for use ________________________________________________________________ 6
1.3 How to read these operating instructions ______________________________________________________ 7
2. Important Notes on Safety (PLEASE READ THIS CHAPTER FIRST) __________________________________ 9
2.1 List of Warnings __________________________________________________________________________ 9
3. Certifications ________________________________________________________________________________ 11
3.1 CE Certification _________________________________________________________________________ 11
3.2 UL Certification _________________________________________________________________________ 11
3.3 Quality management______________________________________________________________________ 11
4. Short Product Overview________________________________________________________________________ 11
5. Guarantee___________________________________________________________________________________ 13
6. Colposcopes _________________________________________________________________________________ 15
6.1 Equipment overview, installation and operation _______________________________________________ 15
6.2 Scope of delivery and testing of the supplied goods _____________________________________________ 15
6.3 Standard Colposcopes ____________________________________________________________________ 16
6.5 OptiK™ Model 2 (3MTL-LED, 3MVL-LED USB, 3MVL-LED Y/C) ______________________________ 17
6.5.2 Camera adapter ______________________________________________________________________ 18
6.6 General Adjustments _____________________________________________________________________ 18
6.6.1 Rough height adjustment _______________________________________________________________ 19
6.6.2 Vertical and Horizontal fine adjustment ____________________________________________________ 19
6.6.3 Compensation of ametropia _____________________________________________________________ 19
6.6.4 Drum Magnification Dial _______________________________________________________________ 19
6.6.6 Green filter __________________________________________________________________________ 20
6.7 Do-It-Yourself Troubleshooting ____________________________________________________________ 21
6.7.1 Fine height adjustment _________________________________________________________________ 21
6.7.2 Hold adjustment for Fine Focus __________________________________________________________ 22
6.7.3 Changing a Halogen Light Bulb __________________________________________________________ 22
6.7.4 Fuses _______________________________________________________________________________ 22
7. Stands ______________________________________________________________________________________ 24
7.1 Swing Stand_____________________________________________________________________________ 25
7.1.1 Swing Stand Assembly _________________________________________________________________ 25
7.1.2 Dimensions __________________________________________________________________________ 25
7.2 The Balance-o-Matic Stand ________________________________________________________________ 26
7.2.1 Balance-o-Matic Stand Assembly_________________________________________________________ 26
7.2.2 Dimensions __________________________________________________________________________ 27
7.3 Tilt Stand and Upright Stand (Roller Base) ___________________________________________________ 28
7.4 Installations _____________________________________________________________________________ 29
2 CooperSurgical, Inc. 95 Corporate Drive, Trumbull, CT 06611 USA

Phone (800) 243-2974 Fax: (800) 262-0105 www.coopersurgical.com
35348 Rev C. 4/08
CooperSurgical LEISEGANG
7.4.1 Installation of Swing Stand on mobile 5-wheel roller base______________________________________ 29
7.4.2 The Balance-o-Matic Stand on weighted 5-wheel roller base ___________________________________ 30
8. Illumination Units ____________________________________________________________________________ 31
8.1 30W Power Supply Unit for Halogen Illumination _____________________________________________ 31
8.3 LED Lighting ___________________________________________________________________________ 33
9. Accessories __________________________________________________________________________________ 34
9.1 Video Adapters __________________________________________________________________________ 34
9.1.1 Mounting Video Adapters __________________________________________________________________ 34
9.2 Cameras________________________________________________________________________________ 36
9.3 Micromanipulator________________________________________________________________________ 37
10. Care and maintenance_______________________________________________________________________ 37
10.1 Colposcope head _________________________________________________________________________ 37
10.2 Stands__________________________________________________________________________________ 37
10.3 Accessories and external devices ____________________________________________________________ 37
11. Replacement wear parts and technical service ____________________________________________________ 39
11.1 Technical service _________________________________________________________________________ 39
11.2 Spare and worn parts _____________________________________________________________________ 39
11.2.1 Lamp change_________________________________________________________________________ 39
11.2.1 Fuses _______________________________________________________________________________ 39
12. Technical data and notes on safety _____________________________________________________________ 40
12.1 EMC - Electromagnetic compatibility _______________________________________________________ 40
12.2 Control and maintenance__________________________________________________________________ 40
12.3 Returns, complaints ______________________________________________________________________ 40
13. Technical Data_____________________________________________________________________________ 41
13.1 Type plates______________________________________________________________________________ 41
13.1.1 Colposcope head ______________________________________________________________________ 41
13.1.2 Power Supply (Illumination Rheostat) _____________________________________________________ 41
13.1.3 LED Power Supply ____________________________________________________________________ 41
13.1.4 Video Adapter________________________________________________________________________ 42
13.2 Classification ____________________________________________________________________________ 42
13.3 Safety Class _____________________________________________________________________________ 42
13.4 Environment Conditions __________________________________________________________________ 42
13.5 Dimensions and weights (all information approx.) _____________________________________________ 43
13.6 Electrical connections _____________________________________________________________________ 43
13.7 Power Consumption ______________________________________________________________________ 43
13.8 Fuses___________________________________________________________________________________ 43
13.9 Lamps _________________________________________________________________________________ 43
13.10 LED Light Specification _________________________________________________________________ 43
Leisegang Colposcopes EMC Compliance Information___________________________________________________ 44
Recommended Separation Distance __________________________________________________________________ 47
www.coopersurgical.com 3
Colposcopes from
Objective Determination
Colposcopes are utilized for the magnified, illuminated gynecological examination of the
female genital organs (vulva, vagina and cervix).
With certain model colposcopes, you can attach cameras or digital image management
systems for subsequent evaluation and 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.
Be sure you read the Instruction Manual in its entirety to gain a basic understanding of how
the colposcope functions before attempting to operate your colposcope.
Should you have any questions, contact CooperSurgical Monday though Friday, 8:30 AM to
5:00 PM E.S.T.
95 Corporate Drive
Trumbull, CT 06611 USA
Phone: (800) 243-2974
Fax: (203) 262-0105
International
Phone: (203) 601-9818
Fax: (203) 601-4747
e-mail: [email protected]
Internet: http://www.coopersurgical.com

35348 Rev C. 4/08
1. Important general references
1.1 Preliminary notes
CooperSurgical and LEISEGANG are renowned for providing innovative technologies and products in
women’s healthcare. LEISEGANG colposcopes were developed in cooperation with practicing
gynecologists. Experience, precision, and continuous manufacturing optimization has enabled
LEISEGANG to become the leading manufacturer of colposcopic precision instruments, with the
largest product range of colposcopes in the world. For over 60 years, LEISEGANG represents
colposcope excellence. LEISEGANG is positioned to meet the evolving needs and requirements of
the practicing gynecologist. Thank you for your purchase!
1.2 Determination-Appropriate Use
Only LEISEGANG accessories, bases, sources of light and camera equipment may be utilized with
LEISEGANG colposcopes.
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.
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 vital prerequisites before using the
colposcope.
The user should check the functional stability and proper condition of the device before every
procedure.
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 keratinized 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-tract surgery: hysterectomy, treatment of genital
prolapse, cervicovaginal plastic surgery, etc.
Colposcopes from
13. Lesion noted on routine gynecologic examination
1.2.2 Contraindications 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.
1.3 Symbols
Symbol Title
! Caution
Reference
Installation
Attention, consult
Accompanying Documents
Protective Earth (Ground)
Date of Manufacture
USB Connection
Caution: U.S. Federal law

Rx Only restricts this device to sale by or on
the order of a physician.
S/N Serial Number

35348 Rev C. 4/08
REF Model or Part Number
Authorized European
EC REP Representative
QTY Quantity
LOT Lot Number
1.3 How to read these operating instructions
These instructions are structured around the operation of the colposcope, from assembly to the
finished system. Basic troubleshooting information is also provided. Our goal is to make these
instructions easily understandable and technically feasible.
The instruction content follows the structure of a colposcope: head, base, accessories, electrics,
maintenance and safety.
The inside edge of each page is exclusively reserved for important key words, symbols and provides
sufficient space for your personal notes.
Symbol meanings are as follows:
Caution: Important notes on safety. Pay close attention to the information and details provided here,
in order to avoid personal injury or device damage.
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, etc.
Installation: The delivery of the goods dispatched from LEISEGANG always includes the tools
Colposcopes from
needed for the installation, such as screwdrivers, Allen keys, etc.

35348 Rev C. 4/08
!
2. Important Notes on Safety (PLEASE READ THIS CHAPTER FIRST)
Before you begin using the colposcope, please become familiar with the following safety regulations
and keep these in mind while using the device:
2.1 List of Warnings
1. The halogen colposcope is equipped with a safety mains cable (plug) and may only be
connected to a surge protector 110V socket and then plugged into a 110V grounded plug
socket.
Note: Light Emitting Diode (LED) colposcopes are Safety Class II products and DO NOT
require grounded power cords or outlets.
2. Do not use 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 halogen illumination lamp should be switched on only for 10
minutes per hour for safety reasons. A halogen device left on can overheat in certain
situations.
5. Use only an authorized LEISEGANG base with your LEISEGANG colposcope.
6. Do not hang any additional objects on the colposcope or on parts of the base.
7. Do not lean on the device.
8. Do not operate the device in an explosive-endangered environment.
9. Defective cables or plugs can cause electrical accidents and fires. Replace defective cables
immediately or call an authorized technician.
10. Do not use power supply units with damaged cases. Contact CooperSurgical for a
replacement.
11. The mains cable (wired plug) should never be removed at the cable connection end, but
always at the plug socket only.
12. Before connecting the power supply to the device, confirm that the mains voltage and
frequency of the wall plug socket agree with the information on the colposcope label.
13. Do not roll the device over deep-pile carpets or over objects on the floor (cables, hoses).
Colposcopes from
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
exclusively by CooperSurgical/LEISEGANG-trained personnel only, since high-voltage live
parts are present in the device or in the subassemblies.
16. CooperSurgical/LEISEGANG is not liable for damages resulting from improper use of their
products or contraventions against safety notes mentioned above.
17. Disposal: Devices produced by CooperSurgical/LEISEGANG and defective parts as well must
be disposed of professionally only according to the valid laws and standards in the operator’s
country.
18. For transportation of 1DL, OptiK Model 1 Colposcopes (1DL-LED) and OptiK Model 2
Colposcopes (3MTL-LED, 3MVL-LED-USB, 3MVL-LED Y/C), place the colposcope head in
the lowest position to assure stability during transportation.
19. For stability of the 1DL, OptiK Model 1 Colposcopes (1DL-LED) and OptiK Model 2
Colposcopes (3MTL-LED, 3MVL-LED-USB, 3MVL-LED Y/C) in normal use, do not extend the
colposcope head greater than 44 inches from the base.

35348 Rev C. 4/08
3. Certifications
3.1 CE Certification
The device is tested according to the specifications of the European Medical Device Directive [MDD]
93/42/EEC, 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/EEC.
The colposcopes are checked for compliance with the basic requirements according to Appendix I of
Guideline 93/42 EEC 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
LEISEGANG colposcopes model 1DS, 3MS, 3MLS, 1DL-LED, 3MTL-LED,

3MVL-LED-USB, 3MVL-LED Y/C. WITH RESPECT TO ELECTRIC
SHOCK, FIRE, AND MECHANICAL HAZARDS ONLY
IN ACCORDANCE WITH UL 60601-1
3.3 Quality management
LEISEGANG Feinmechanik-Optik GmbH Company has an established quality management system

according to ISO 9001 since 1995, upgraded 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 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]
4. Short Product Overview

Specific terms and technical solutions related to LEISEGANG colposcopes are explained below. For
older LEISEGANG colposcopes, you may need to reference other manuals.
Colposcopes from
• 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
topography and blood vessels of the examination subject. All LEISEGANG colposcopes, from
OptiK Model 1 Series to OptiK Model 2 Series, have the same Leisegang quality optics and all
offer true 3D stereoscopic viewing.
• Each of the two oculars, or eyepieces, can be adjusted to meet individual eye needs from +7
to -7, so that the operator can work with or without viewing aids. Eyecups can be removed if
the user chooses to wear glasses.
• Convergent viewing beam paths correspond

to the natural viewpoint; and, in contrast to Optical Beam Path
parallel mode, focus precisely 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
convergent optical beam is ergonomic by
avoiding excess eye strain.
Convergent Unaided Eye Parallel
• Measuring Reticule Rings are installed in the left ocular pathway to allow you to quickly
assess lesion size under direct visualization. A measurement reference chart is located on the
left ocular. The chart contains mm measurement for rings A and B at each magnification
setting.
• In this document, the term colposcope head refers only to the actual colposcope examination
instrument head while the term colposcope describes the entire device with all accessories,
from the mount to the power and light source, up to the mains cable.
• A par focal lens is an objective that stays approximately in focus when the magnification is
changed. For example, if a colposcope is switched from a low power (3.75×) to a high power
(7.5×), the object stays in focus. A par focal lens is not present in all colposcopes, although
higher quality colposcopes like Leisegang have this feature. The diagram below shows the par
focal distance that is necessary in order to achieve proper viewing distance. The numbers
above the dots indicate the area of forgiveness where you can look thought the colposcope
and view the cervix right before it gets distorted or out of focus.

35348 Rev C. 4/08
• LEISEGANG colposcope heads are further distinguished according to model series and
type. Every device head bears a punched five-digit serial number, as well as type
identification. The identification begins with a digit and up to four more alphabetic characters in
accordance to the colposcope type. Every alphabetic character has its 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 = 3.5/7.5/15x magnification, also for photography
V = Video colposcope with integrated camera
L = Photo colposcope, without electronic flash
• The colposcopes of the 1DL, 3ML, 3MLS, 3MTL, OptiK Model 1 series (1DL-LED) and OptiK
Model 2 series (3MTL-LED, 3MVL-LED-USB, 3MVL-LED Y/C) are equipped with a rotary
changeover for three magnification stages. The scales with the magnification change are 1:2
in each case and result in natural progression of an unmistakable image. In detail, the
following magnifications are available: 3.75/7.5/15x.
5. Guarantee
CHANGES IN SPECIFICATIONS FOR PRODUCT. All specifications for the Product are subject to
change without notice.
COOPERSURGICAL INC., TRUMBULL, CT 06611 USA.

Contents of this User Manual and other written materials provided to Licensee with the Product may
not be reproduced by any means whatsoever without prior written permission from CooperSurgical,
Inc. All products mentioned in this User Manual and related written materials are trademarked or
copyrighted by their manufacturers.
All CooperSurgical, Inc., Products are covered by U.S. and other patents and/or patents pending. All
product names are trademarks of CooperSurgical, Inc. All trademarks and the rights of the
trademarks owned by the companies referred to in this User Manual and other written materials
provided to Licensee with the Product are acknowledged.
Colposcopes from
WARRANTY FOR PRODUCT
The Product manufactured by CooperSurgical, Inc., is warranted against defects in material and
workmanship for twelve (12) months from date of installation. During the warranty period,
CooperSurgical, Inc., will repair or replace (at its option) a Product proven to be defective. Warranty
repairs may be performed on site, at the factory, or at a CooperSurgical, Inc.,-approved service center
without charge, provided the Product was not subjected to misuse, theft, neglect, fire, Acts of God,
lightning strikes, or deterioration caused by chemicals that are not used for normal unit operation.
Any modifications of the Product in any manner, including but not limited to relocation or installation of
the Product without prior CooperSurgical, Inc., Customer Service authorization, shall void all
associated warranties or service contracts. Prior to prepaid return of products for repair, the Product
must have a Return Authorization Number (obtainable from CooperSurgical, Inc., Customer Service)
attached to it.
BEYOND THE WARRANTIES STATED ABOVE, THERE ARE NO OTHER WARRANTIES OF ANY
KIND, EXPRESS, IMPLIED OR STATUTORY (INCLUDING, WITHOUT LIMITATION, TIMELINESS,
TRUTHFULNESS, SEQUENCE, COMPLETENESS, ACCURACY, FREEDOM FROM
INTERRUPTION), ANY IMPLIED WARRANTIES ARISING FROM TRADE USAGE, COURSE OF
DEALING, OR COURSE OF PERFORMANCE, OR THE IMPLIED WARRANTIES OF
MERCHANTABILITY OR FITNESS FOR A PARTICULAR USE OR PURPOSE. LICENSEE’S
EXCLUSIVE REMEDY FOR BREACH OF WARRANTY OR BREACH OF CONTRACT,
NEGLIGENCE OR PRODUCTS LIABILITY SHALL BE THE REPAIR OR REPLACEMENT OF
DEFECTIVE OR DAMAGED GOODS.

35348 Rev C. 4/08
6. Colposcopes
6.1 Equipment overview, installation and operation
Before actual use and installation of your device, check the outside of the transport packaging, the
devices or subassemblies supplied for damage.
The following chapters give step by step instructions for the testing, installation, operation and security
references.
If at this point you notice an obvious defect, please immediately contact CooperSurgical:
CooperSurgical
Attn: Service and Repair
95 Corporate Drive
Trumbull, CT 06611
800-444-8456
6.2 Scope of delivery and testing of the supplied goods
The scope of delivery of a complete LEISEGANG colposcope always includes at least the following
four items:
1. The colposcope head
2. The base with special part set (special installation equipment and instructions etc.)
3. The power and light source, i.e. transformer
4. The accessories, i.e. cables, spare lamps, tools, fitting instructions etc.
Possibly associated with the scope of delivery:

5. Additional accessories, such as photographic and video cameras, adapters and external
devices such as monitors, laptop computer etc.
These 5-items correspond to the Installation and Operating Instructions. In the case of item 5, please
refer to the additionally provided instructions. Please note that during the assembly of the device or
devices, the base is always assembled first, then the power and light source and finally the
colposcope head with accessories.
Colposcopes from
6.3 Standard Colposcopes
The following information is for reference of our standard halogen colposcope, Model 1DL:
Model 1DL (1DS)

• 3-step magnifications (3.75x/7.5x/15x)
• Inbuilt 12V/20W Halogen lamp
• Individually adjusting oculars
• Measuring reticules in optical pathway for lesion assessment
• Gross and fine focusing and height adjustments
• Green filter
• Ability to upgrade to digital colposcopy systems or Analog camera (with additional purchase)
The next section refers to our Light Emitting Diode (LED) colposcopes:
OptiK™ Model 1 (1DL-LED)
OptiK Model 1 series includes LEISEGANG popular standard colposcopes with precision fine
adjustments in horizontal and vertical direction, green filter, high performance optics and LED lighting.
FEATURES
OptiK™ Model 1 (1DL-LED)

• 3-step magnification drum changer (3.75x/7.5x/15x)
• Inbuilt 24V/18W LED lamp
• Individually adjusting oculars with measuring reticles
• Green filter
• Ability to upgrade to digital colposcopy systems or Analog camera (with additional purchase)

35348 Rev C. 4/08
6.5 OptiK™ Model 2 (3MTL-LED, 3MVL-LED USB, 3MVL-LED Y/C)
The Colposcopes of OptiK Model 2 series are LEISEGANG’s popular Digital/Photo colposcopes with
precision fine adjustments in horizontal and vertical direction, high performance optics and LED
lighting. The plate identifications for OptiK Model 2 vary according to the camera configuration
purchased.
OptiK Model 2
FEATURES
OptiK™Model 2 (3MTL-LED, 3MVL-LED USB, 3MVL-LED Y/C)

• 3-step magnification drum changer (3.75x/7.5x/15x)
• Inbuilt 24V/18W LED Lamp
• Individually adjusting oculars with measuring reticules
• Available in either 1.0” or 0.5” optimized charge coupled device (CCD) with external camera-
ready port with matching magnification (3MTL-LED). Or, available with integrated camera
(3MVL-LED USB or 3MVL-LED Y/C)
• Green filter
Colposcopes from
6.5.2 Camera adapter
You can connect an Analog camera (LM-1P) or digital camera (Infinity series) to the OptiK Model 1
with a video camera adapter. You can connect an Infinity series digital camera to the port of the OptiK
Model 2 (3MTL-LED 0.5” only)). Or, you can connect a digital SLR camera (Canon Rebel XTi 400D)
to the port of OptiK Model 2 (3MTL-LED 1.0” only). You will need a special tubus/bayonet depending
on the camera. The kind of tubus can be a T2 Adapter, Video Adapter or C-mount Camera adapter in
several sizes. The tubus/bayonet screws onto the front of the camera. If you received the wrong
adapter, please contact us.
The OptiK Model 2 (3MTL-LED) series Photo-Colposcopes have a port for the camera. The internal
optics are optimized for 1.0” CCD or 0.5” CCD; however, they are not interchangeable. If you have
purchase 1.0” CCD optimized you must use a 1” CCD or CMOS camera. If you have purchased a 0.5”
CCD optimized you must use a 0.5” CCD or CMOS camera. The camera is attached below the
colposcope head. Refer to your specific camera’s directions for use for more information.
You have to use cameras without objective lens. Attach the bayonet to the
camera body to insert the camera into the shaft, and secure by hand tightening the
small black adjacent to the camera.
The OptiK Model 2 is also available with an integrated camera (3MVL-LED Y/C or 3MVL-LED USB)
and monitor.
6.6 General Adjustments
Most adjustments are the same for all Leisegang colposcopes. Normal adjustments mean the daily
use adjustments such as adjusting height, focusing, choosing the magnification, or turning on the
green filter.

35348 Rev C. 4/08
6.6.1 Rough height adjustment
Every colposcope head is packed into a solid plastic bag on delivery, to protect against dust and dirt.
The head always represents the last assembled part. It should remain in the bag until final assembly.
After assembled, use the supplied dust cover to protect the colposcope while it is not in use.
Take the colposcope head from the bag and guide the chrome-plated insertion tube into the
previously assembled base. Fix it at the standard height appropriate for the colposcopy, and lightly
hand tighten with the aid of the black clamping knob. Ensure that the insertion tube is inserted far
enough into the mount for a solid fit.
With this knob you can adjust the height of the colposcope in a rough
position convenient to your posture. The fine adjustment is achieved
with the fine adjustment handle (See item 1 in 6.6.2).
6.6.2 Vertical and Horizontal fine adjustment
The most used adjustments are the horizontal and vertical

adjustments of the colposcope head. Use the vertical adjustment for your posture/height and the
horizontal adjustment for focusing the object.
1 Turning this handle results in a vertical movement of the

colposcope 1.
2 Turning this handle results in a horizontal movement of the

colposcope 2. You will use this handle to focus the image.
3 Inclining this handle results in the tilt of

the colposcope head 3. You will use this handle to focus
the image by twisting the handle.
6.6.3 Compensation of ametropia
Every LEISEGANG colposcope has individual adjusting

oculars to compensate for both eyes in a diopter range
of +7 to -7.
6.6.4 Drum Magnification Dial
Colposcopes from
You can choose the right magnification / view area for your observation by turning the magnification
dial.
Field of view in mm
Magnification 3.75x/7.5x/15x
(OptiK Model 1 and OptiK
Model 2 )
76
40
19
6.6.5 Focusing the Leisegang Colposcope

• The working distance of a properly focused Leisegang colposcope is about 300 mm or 11.8
inches. A sheet of paper, at 11 inches, is a good starting reference for length between the
colposcope and the object of focus.
• Move the scope head to the center of the traveler using the fine focus adjustment handle.
• Set both oculars to zero (20/20 vision) and set the step magnification dial to 15x. (The clinician
begins an exam at the lowest magnification; however, once you focus at 15x, you will be in
focus at 7.5x and 3.75x).
• Adjust the interpupillary distance (eye separation) to your face, until a single image is visible.
This is done by adjusting the binoculars wider or narrower.
• Looking through the left eyepiece at the targeting reticules only, rotate the left ocular eyepiece
until the two double circles are clearly focused. When this is achieved, do not touch this
eyepiece for the remainder of the exam.
• To adjust gross focus, move the colposcope back and forth until you can see the test object
clearly with your left eye in the left eyepiece.
• Rotate the right ocular until you can see the object clearly with your right eye.
• At this point the colposcope is par focalized. During this exam and all that follow for a
particular user there would be no need to touch the two eyepieces.
• View using both eyes. If needed, move the colposcope back and forth in relation to the subject
and adjust the fine focus. With the colposcope par focalized you will have about 300 mm (12
inches) of working distance.
6.6.6 Green filter
With the knob on the right side of the scope you can turn the
Green filter in and out.

35348 Rev C. 4/08
6.7 Do-It-Yourself Troubleshooting
All LEISEGANG Colposcopes and accessories are adjusted prior to shipping. Over the years, daily
usage may require you to make special adjustments to the colposcope, such as rough height hold
adjustment, etc. This chapter provides an introduction to Do-It-Yourself Troubleshooting.
6.7.1 Fine height adjustment
Over the years, your scope head’s fine adjustment may need to be tightened in order to hold position.
To fix this, you can perform the following steps:
1.) Bring the scope in a higher position
2.) Shift the metal cover with type label up
3.) Tighten the screws a little bit until it is fixed enough
4.) Shift the cover down to the origin position
Colposcopes from
6.7.2 Hold adjustment for Fine Focus
If the colposcope will not hold the fine focus adjustment position,
slightly tighten the knob below the magnification dial.
6.7.3 Changing a Halogen Light Bulb
Changing a defective halogen bulb is very easy for all LEISEGANG Colposcopes.
Please switch off the device before you change the bulb. To remove the light bulb, pull the
bulb holder from the colposcope head. Pull the defective halogen bulb from the holder. Do not touch
the new light bulb with your hand, since skin grease on the lamp glass considerably decreases the
life of the bulb. Using a cloth, insert the bulb into the bulb holder, and insert into the scope head. (See
Section 8.3 LED Lighting for LED information)
CAUTION: The lamp can be hot! Never

touch the new lamp with your bare
fingers!
Note: Should you experience LED light failure, please check the power supply unit first. If you require
LED light bulb change, it should only be done by an electrical specialist or by CooperSurgical.
6.7.4 Fuses
Fuse holders are located at the power supply of

illumination unit. 2 fine-wire fuses are located in a
fuse holder. After switching off the device and
unplugging the power supply from the device, the
fuse holder can be pulled out from the casing with a
screwdriver. The fine-wire fuses can be withdrawn
and replaced by removing from the fastener and
inserting a new one. Then plug in the main cable.
The fuses cannot be replaced without unplugging the
power supply. Be sure that new fuses have the same
values as the defective ones.
M

35348 Rev C. 4/08
aPlug with Fuse Holder
Pull out the fuse holder and Change the fuses
Colposcopes from
7. Stands
All LEISEGANG stands (base or mount) are characterized by the highest levels of quality and stability
for daily use in practices and clinics. The decision on the type of stand should be made prior to
ordering, since the respective stands differ.
The following paragraphs deal with the stand types available at LEISEGANG:
• Swing Stand
• Balance-o-Matic Stand
• Tilt Stand
• Upright Stand (Roller base)
The stand assembly is the first thing built with every new colposcope order.
Please follow the individual stages of the fitting instructions for the respective stand form in the
numerical sequence indicated, in order to avoid damage to the device or individual subassemblies.

35348 Rev C. 4/08
7.1 Swing Stand
The Swing Stand is the most popular stand worldwide. It consists of two
right-angled tubular frames, which enable a horizontal radius of 60 cm
with almost 360° pivoting capability.
In addition, the Swing Stand base is a 5-wheel mobile rolling base with
two locking casters, which offers free but stable mobility.
Swing Stand with heavy spider base
7.1.1 Swing Stand Assembly
See 7.2.1 Balance-o-Matic Stand Assembly
The assembly for both stands is nearly the same.
The next step is assembling the illumination unit, see Chapter 8.
7.1.2 Dimensions
Colposcopes from
7.2 The Balance-o-Matic Stand
The LEISEGANG Balance-o-Matic Stand offers a maximum of

comfort with the greatest ease of operability. A two-stage brake
arm (1) at the lower stand frame enables the fixed setting of the
stand, as soon as the operator has carried out the rough
adjustments in the horizontal and vertical direction.
7.2.1 Balance-o-Matic Stand Assembly
Loosen the cross connection (4) and remove with the supplied
Allen key. The clamp (3) is displaced upwards with the slit casing
over the protection pin (5) and the cross connection is secured
again. Ensure the protection pin (5) remains accessible for
changing the spring loading.
For the purposes of weight compensation, an extension spring is

located in the external stand tube, whose loading must be
adapted to the weight of the colposcope head, as well as to
additional subassemblies, by means of a control ring (8). For the
adaptation, an Allen key or screwdriver is inserted into one of the
holes of the ring; this is then rotated a little to the right against the
spring force and the protection pin (5) is pulled out. For safety
reasons, a second Allen key or screwdriver should be at hand,
since the slow loading or unloading of the spring requires a
reinsertion of the lever into the control ring.
Caution: By removing the protection pin, the entire weight of

stand, colposcope head and accessories is now supported at the
lever inserted in the ring! If this slides out, the spring in the tube is
unloaded and the entire colposcope will suddenly collapse. For
this reason it is recommended to fix the stand in the center
position before the removal of the protection pin and only then to begin with the settings, or however,
a second person helps by supporting the stand arm.
The ring (8) is now rotated against or with the spring loading until the above-mentioned balanced
suspension status of the colposcope is achieved. The ring is arrested again by the reinsertion of the
protection pin. Here, the ring is rotated a little back and forth until a hole for the protection pin is found.
With this, the Balance-o-Matic Stand would be firmly connected.

As a next step the illumination unit shall be assembled, see Chapter 8.

35348 Rev C. 4/08
7.2.2 Dimensions
Colposcopes from
7.3 Tilt Stand and Upright Stand (Roller Base)
The Tilt stand is a stable stand for colposcopy and is

easily transportable. Rough focus adjustment is
achieved by changing the tilt angle.
For transportation of 1DL, OptiK Model 1 Colposcopes

(1DL-LED) and OptiK Model 2 Colposcopes (3MTL-
LED, 3MVL-LED-USB, 3MVL-LED Y/C), place the
colposcope head in the lowest position to assure
stability during transportation.
For stability of the 1DL, OptiK Model 1 Colposcopes (1DL-LED) and OptiK Model 2 Colposcopes
(3MTL-LED, 3MVL-LED-USB, 3MVL-LED Y/C) in normal use, do not extend the colposcope head
greater than 44 inches from the base.
The ball joint (1) is screwed securely to the base plate, using the 4
hexagon socket screws. A suitable Allen key is included in the scope
of delivery. The red bolt at the bottom of the base plate (2) adjusts
the clamping force of the ball joint and determines the force that is
necessary to tilt the stand. The narrow side of the base plate and the
transformer are supposed to face toward to the examiner. The
clamping button (3) serves, as in the case of other stands, to
determine the height of the colposcope.
In the case of the Upright Stand with light 5-wheel roller base, the
same upright stand is used as with the Tilt stand; however, the
difference is that the base plate has been replaced by a light rolling
base.
Unlike the Tilt, this Upright Stand is not equipped with a tilting link,
so that the rough adjustment must be implemented through the
movement of the entire system. The fine adjustment is first carried out again, using the focusing
drives at the colposcope head.
The stand tube must be inserted with the lower ends (cf. drawing on the opposite page) into the rolling
base and tightened up with a locking bolt. There are no further settings possibilities for this stand,
except that 2 of the 5 rollers can be set with a brake.

35348 Rev C. 4/08
7.4 Installations
7.4.1 Installation of Swing Stand on mobile 5-wheel roller base
1. The stand upright (1), equipped with a black cone, is inserted into the corresponding receptacle of
the 5-wheel roller base (2). The locking weight is securely screwed from below onto the column,
using the supplied hexagon socket screw and the spacing washer; the cap (3) is placed securely
over the locking weight in order to visually conceal this.
2. The star-shaped handle (4) is used for the guiding of the stand while rolling. After intermediate
insertion of the fan washer, it is screwed into the column (5) and tightened up well. Two of the five
rollers have a locking facility (6) against unintentional movements of the system.
3. The stand has been preset in the factory to a predetermined height. In order to change this,
slightly pull out the small locking pin (7) at the supporting ring of the lower stand frame and adjust
as needed to one of the existing boreholes. Please ensure that the pin audibly engage, in order to
prevent slipping of the stand and possible injuries.
4. The Swing Stand is now firmly assembled. For fine adjustment of the horizontal pivot movement
you can tighten or loosen pressure screws (8) with a coin at two points.
Colposcopes from
7.4.2 The Balance-o-Matic Stand on weighted 5-wheel roller base
The stand upright (1), equipped with a black cone,

is plugged into the corresponding receptacle of the 5-wheel
roller base (2). The locking weight is securely screwed from
below onto the column, using the supplied hexagon socket
screw and the spacing washer; the cap (3) is placed securely
over the locking weight in order to visually conceal this.
Two of the five rollers have a locking facility (6) against

unintentional movements of the system.
As a next step the illumination unit shall be assembled, see

Chapter 8.

35348 Rev C. 4/08
8. Illumination Units
Two basic power supplies are available for lighting.
• Power Supply 30W for Standard-

Colposcopes with 20W Halogen-illumination
• Power Supply 18W for LED-illumination.
Note that the box provides an insulated
ground versus a wired ground.
8.1 30W Power Supply Unit for Halogen

Illumination
The 30W Power Supply supplies the lamp enclosed

in the colposcope head. The main switch is located
on the front, with a lighted indicator lamp and a
rheostat illumination control dial.
The Power Supply can be mounted on the Swing or

Balance-o-Matic Stand between the two tubes of the
upper frame. For Upright Stands you have to use two
clamps.
Front Back
Colposcopes from
!
Be careful while unscrewing the 4 screws, as it holds the
two sides of the case together. Before unscrewing the
case, unplug the unit from mains/primary voltage.
At the end of power supply unit you will find the two plugs for
primary and secondary voltage. The primary voltage plugs
holds two fuses. Plug in the lamp cable from colposcope head
and turn clockwise until locked.
The illumination unit is approved according to the relevant DIN

IEC Standard and carries the serial number on the label.
The illumination unit may be operated only with alternating current with the frequency and voltage
indicated on the label. It is not approved for operation in areas with explosion danger.
!
SAFETY ADVICE
The halogen illumination unit should be switched on for only 10 minutes per hour for safety reasons. A halogen
device switched on longer than this can overheat in certain situations.

35348 Rev C. 4/08
8.3 LED Lighting
LED stands for Light Emitting Diode - this light is produced in an

electronic process in semiconductor without substantial heat losses.
LED Colposcopes are equipped with an LED unit. This consists of a

heat sink unit with LED and the condenser lens optics. The brightness
clearly exceeds that of standard colposcopes with 20W halogen bulb.
In addition, it provides another light character for a more enhanced
visualization than the lamps used in the past.
LED unit
The used power supply unit weighs 500g or 1.10lb and possesses a power consumption maximum of
18W.
With a life span greater than 20,000 operation hours, this LED lighting can last a whole working life
(Estimated at 4 hours per working day). Should you experience LED light failure, please check the
power supply unit first. If you require LED light change, it should only be done by an electrical
specialist or by CooperSurgical.
Colposcopes from
9. Accessories
LEISEGANG offers several kinds of accessories:
• Video Adapter
• Cameras
• Image Management Software

• Bases
The following sections provide more information on the above bold items.
9.1 Video Adapters
All LEISEGANG colposcopes accept the Leisegang video adapter via a mounting plate which can be
mounted with 3 screws at the front of the scope. The video adapter can easily be mounted using the
supplied tools.
LEISEGANG Video Adapters are available in the US with three-step magnification of 3.75x, 7.5x, 15x.
Please refer to the camera’s specific directions for use for more information.
9.1.1 Mounting Video Adapters
1. Fastening of VA mounting base plate

Fasten the mounting base plate with three screws
2. Alignment of video adapter

Align the mounting plate and video adapter fasten area
one above the other

35348 Rev C. 4/08
3. Attaching the video adapter
Push both pins of video adapter fasten area into

mounting base plate and tighten the screw knob
clockwise
4. Video adapter is ready to use
Colposcopes from
9.2 Cameras
CooperSurgical offers different cameras for specific purposes.
LM-1P Analog with S-Video Lumenera Infinity Digital Cameras Canon Digital Rebel XTi (400D)
LM-1P analog cameras display at the normal TV resolution and show live images on a monitor. They
do not capture images but are excellent for teaching. These basic cameras are designed for use with
the 1DS,1DL and OptiK Model 1 (1DL-LED) colposcope, using a video adapter and a special
tubus/bayonet.
Integrated Cameras are an economic choice for teaching and displays live images on either a
monitor at 752 H x 582 V, the normal TV resolution (3MVL-LED Y/C) or a computer at 0.5 mega pixels
(3MVL-LED USB). This camera is only available at the time of purchase with OptiK Model 2 with
Integrated Camera. The digital version is only available with our digital colposcopy software,
CerviPATH Patient Management.
Lumenera Infinity digital cameras are available with digital colposcopy systems only. The
CerviPATH systems are programmed with the Infinity 1 camera (1.0 mega pixels) while the
ImageQUEST systems are programmed with the Infinity 3 camera (3.1 mega pixels). Live images are
viewed on the digital colposcopy system’s laptop. The Infinity cameras are designed for use with
digital colposcopy systems. and either the 1DL, 1DS or OptiK Model 1 (1DL-LED); or, the OptiK Model
2 with 0.5” CCD (3MTL-LED) and a special bayonet. Still images can be exported through the digital
colposcopy system software rather than through the camera itself.
SLR camera Canon Digital Rebel XTi 400D (10.1 mega pixels) is designed for use with the OptiK
Model 2 with 1.0” CCD (3MTL-LED 1.0”), using a special bayonet. A potential disadvantage of these
cameras is that they are unable to create a live video picture. However, the image quality from these
cameras is excellent for academia, gynecologic oncology studies, Sexual Assault/Physical Abuse
cases, or other clinical trials. Images are saved to a memory card for manual export.
Please refer to the appropriate Directions for Use (DFU) for more information if you have purchased
these items.

35348 Rev C. 4/08
9.3 Micromanipulator
LEISEGANG colposcopes can connect to micromanipulators by a mounting base. CooperSurgical

does not sell micromanipulators or their mounting adapters, but we can refer you to suppliers.
10. Care and maintenance

Colposcope care and maintenance is simple - no great effort is needed to keep your device in a tidy
and functional condition. It is recommended that the colposcope be handled with gloves. We also
recommend that you consistently carry out the measures described below, in order to ensure long-
term and trouble-free functioning.
10.1 Colposcope head
For the protection of the colposcope head and, in particular, the optical system, we recommend
placing a dust cover over the colposcope head after every use, in order to minimize dust
contamination of the device. The colposcope head should be wiped with a moist cloth at regular
intervals (Note: moist, not wet).
Liquid splashes on the front panel can occur with device usage and these should be wiped off. If the
external optics are soiled, they should only be cleaned with commercially available lens cleaning
papers or moist spectacle cleaning cloths.
Disinfecting: Lugol’s solution will damage the enamel finish and is very difficult to remove. Moisten a
cloth with diluted alcohol and wipe the enamel to remove Lugol’s. Standard detergents can also be
employed with the usual dilution.
Please do not use strong detergents or concentrated alcohol under any circumstances for the
cleaning of optics. This would lead to irrevocable damage to the optically coated lens surfaces.
Please never use corrosive materials or strong cleaning materials on the casings or on the optics.
Such materials lead to permanent damage of the painted surface of your device and/or scratch the
lens coatings of the optics. This leads to considerable loss of quality of the entire visual system.
10.2 Stands
Similar to the colposcope head, the stands should be wiped as needed with a moist (not wet) cloth.
Further cleaning on the stands is not necessary. The colposcope finish is a high- gloss baked enamel
and can be polished with ordinary household furniture wax.
Disinfecting: Lugol’s solution will damage the enamel finish and is very difficult to remove. Moisten a
cloth with diluted alcohol to remove Lugol’s from the enamel. Standard detergents can also be
employed with the usual dilution.
10.3 Accessories and external devices
In the case of accessories, video adapters and photographic adapters, these should be wiped
externally, if required, using a slightly moist cloth. Optics, which are easily accessible from outside,
Colposcopes from
should be cleaned with optics cleaning agents, analogous to the optics of the colposcope head.
Please do not attempt to clean the optics in the interior of video and photographic adapters, since
these can be easily knocked out of adjustment and/or damaged and so that a repair becomes
necessary. In the case of soiling in the interior of accessories, please contact CooperSurgical.

35348 Rev C. 4/08
11. Replacement wear parts and technical service
11.1 Technical service
When contacting CooperSurgical’s Service and Repair department for servicing LEISEGANG
colposcopes, you will need the following information: Details on the defect that has occurred and
corresponding serial numbers of the individual components. These can be read off from the punched
digits on the metal labels. In the case of the individual subassemblies, the labels are situated at the
following locations:
• Colposcope head with standard and photo colposcopes (Series 1-3): At the insertion tube on the
cap
• Transformer: On the reverse side of the operating controls.
• Video adapter: On the side.
Communication of the serial number expedites the support from CooperSurgical.
For questions concerning service, please contact us at:
95 Corporate Drive
Phone: (800) 444-8456

Fax: (203) 262-0105
International
Phone: (203) 601-9818
Fax: (203) 601-4747
11.2 Spare and worn parts
As well as these directions for use, there is a spare parts list in which all relevant spare and wear
parts are listed. Repairs and interventions on the devices are to be carried out only by
CooperSurgical. Some items may be remedied by the user, such as replacement of worn parts
including: lamps, eyepiece rings, light guides and fuses. The procedure is described below.
11.2.1 Lamp change
SEE CHAPTER 6.7 Troubleshooting
11.2.1 Fuses
SEE CHAPTER 6.7 Troubleshooting
Colposcopes from
12. Technical data and notes on safety
12.1 EMC - Electromagnetic compatibility
LEISEGANG transformers are tested and secure with regard to EMC compatibility. They correspond
to the specifications. Use only approved and authorized Leisegang components. Compliance with the
corresponding specifications is indicated by the CE marking.
12.2 Control and maintenance
Quality controls are carried out for all LEISEGANG devices. The following best practices
are recommended:
1. Ensure that cables, light guides, cable releases and other cables are not too tight or tangled.
Unplug tangled connections and plug these back after unraveling.
2. Ensure that electric connections and mains cables do not indicate any external damage.
Replace defective cables immediately.
3. Occasionally check that the locking weight under the roller base has not loosened. If so,
tightened screws.
4. Ensure that mechanical adjustments are working smoothly and correctly. In case of
occurrence of problems, contact Cooper Surgical Service and Repair Department
5. Regularly check the steel pulling cable for wear.
12.3 Returns, complaints
Returns of devices or subassemblies requires prior arrangement with CooperSurgical through a

Service and Repair Authorization form. Please contact our Service and Repair department to discuss
the issue, repair estimates and to make arrangements. Complaints about devices or subassemblies
supplied by us are to be communicated to us immediately, with information of the serial number, the
delivery date and the reason for the complaint. Please send your complaint in writing to the following
address (Fax or e-mail is sufficient):
95 Corporate Drive
Phone: (800) 243-2974
Fax: (203) 262-0105
International
Phone: (203) 601-9818
Fax: (203) 601-4747

35348 Rev C. 4/08
13. Technical Data
13.1 Type plates
Except for stands, all LEISEGANG devices carry type plates. The contents of type plates show the
product name and the serial number. Electrical devices show the power data and additional
information such as year of construction and CE and/ or UL mark.
13.1.1 Colposcope head
This plate is located below the head.

It shows the Model Type and serial
number.
The serial number is important if you

have any questions or complaints.
13.1.2 Power Supply (Illumination Rheostat)
This plate is located on the front side of the power

supply.
It holds the Model Type and serial number, the primary

and secondary voltage, the year of construction and CE-
mark.
The serial number is important if you have any questions

or complaints.
13.1.3 LED Power Supply
This plate is located on the front side of the power supply.
Colposcopes from
13.1.4 Video Adapter
This plate is located below the head.

It holds the Model Type and serial number.
The serial number is important if you have any questions

or complaints.
13.2 Classification
Classification according to MPG (and Guideline 93/42/EEC): Class 1 –

Halogen and Class II - LED
Application part
13.3 Safety Class
Model Safety Class
Halogen Unit I
LED Unit II
o ALL Models of colposcopes have no Applied Parts.

o Do not get fluid into the colposcope. Should any liquid or solid object fall into the unit or power
supply brick, unplug the unit and call CooperSurgical at 1-800-444-8456.
o The LED model colposcopes are suitable for continuous operation.
13.4 Environment Conditions

Use:
Environmental Temperature: between +10 °C and +45 °C
Relative Humidity: between 30% and 75%
Air Pressure: between 700 hPa and 1060 hPa
Shipping and Storage:

Environmental Temperature: between +10 °C and +45 °C
Relative Humidity: between 30%-75%
Air Pressure: between 700 hPa and 1060 hPa

35348 Rev C. 4/08
13.5 Dimensions and weights (all information approx.)
Standard colposcope head 3.5 kg

Swing Stand 7.0 kg
Balance-o-Matic Stand with weighted base 24.5 kg
Upright stand with roller base 7.0 kg
Tilt stand 3.0 kg
30 VA Power Supply for 20W Halogen-Illumination 1.3 kg
LED Power Supply 0.5 kg
Roller base footprint 65 x 65 cm
Tilt footprint 30 x 30 cm
13.6 Electrical connections
Halogen Colposcopes
Rated voltage: Please note information on label! 100V / 110V / 120V /
230V / 240V
Nominal frequency: Please note information on label! 50/60 Hz
LED Colposcopes
Rated voltage: Please note information on label! 100 - 240V~
Nominal frequency: Please note information on label! 50/60 Hz
Current 2A
13.7 Power Consumption
Power Supply 20W halogen lamp (all models except F-version) 30 VA

Power Supply 18W LED (LED Colposcopes only) 24 VA
13.8 Fuses
Power Supply 20W halogen lamp

110V / 120V 5 x 20 mm; 315 mA; T
Power Supply (Y/C Model also) LED 40W
100 -240V 5 x 20 mm; 2A; T
13.9 Lamps
Halogen lamp 12V / 20 W

LED module with heat sink, LED and Condensor optic 24V / 18W
13.10 LED Light Specification
Correlated Color Temperature Index 5600K

Rendering Index 80
Total Irradiance 183W/m2
Colposcopes from
Leisegang Colposcopes EMC Compliance Information
• MEDICAL ELECTRICAL EQUIPMENT needs special precautions regarding EMC and needs
to be installed and put into service according to the EMC information provided in the
ACCOMPANYING DOCUMENTS.
• Portable and mobile RF communications equipment can affect MEDICAL ELECTRICAL

EQUIPMENT.
Guidance and Manufacturer’s Declaration – Electromagnetic Emissions

LEISEGANG Colposcopes are intended for use in the electromagnet environment specified below. The
customer or the end user of LEISEGANG Colposcopes should assure that it is used in such an
environment.
Emissions Test Compliance Electromagnetic Enviroment- guidance

Leisegang Colposcopes use RF energy only for it internal function.
RF emissions
Therefore, its RF emissions are very low and are not likely to cause
Group 1
any interference in nearby electronic equipment.
CISPR 11
Leisegang Colposcopes are suitable for use in all establishments,
RF emissions
including domestic establishments and those directly connected to the
Class A
public low-voltage power supply network that supplies buildings used
CISPR 11
for domestic purposes.
Harmonic emissions
Class A
IEC 61000-3-2
Voltage fluctuations/
Flicker emissions Complies
IEC 61000-3-3
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity

LEISEGANG Colposcopes are intended for use in the electromagnet environment specified below. The
customer or the end user of LEISEGANG Colposcopes should assure that it is used in such an environment.
IEC 60601
Immunity Test Compliance Level Electromagnetic Environmental - guidance
Test Level
Floors should be wood, concrete or ceramic
Electromagnetic +6 kV contact +6 kV contact
tile. If floors are covered with synthetic
discharge (ESD)
material, the relative humidity should be at
+8 kV air +8 kV air least 30%.
IEC 61000-4-2

35348 Rev C. 4/08
Mains power quality should be that of a typical
Electrical fast +2 kV for power +2 kV for power
commercial or hospital environment.
transient/burst supply lines supply lines
IEC 61000-4-4 +1 kV for input/output +1 kV for

lines input/output lines
Mains power quality should be that of a typical
Surge +1 kV differential +1 kV differential
commercial or hospital environment.
mode mode
IEC 61000-4-5
+2 kV common mode +2 kV common
mode
Voltage dips, Mains power quality should be that of a typical
<5 % UT <5 % UT
short commercial or hospital environment. If the
(>95 % dip in UT) (>95 % dip in UT)
interruptions and user of the Leisegang Colposcope requires
for 0.5 cycle for 0.5 cycle
voltage variations continued operation during power mains
interruptions, it is recommended that the
on power supply 40 % UT 40 % UT Leisegang Colposcope be powered from an
input lines (60 % dip in UT) (60 % dip in UT) uninterruptible power supply or a battery.
IEC 61000-4-11 for 5 cycles for 5 cycles
70 % UT 70 % UT
(30 % dip in UT) (30 % dip in UT)
for 25 cycles for 25 cycles
<5 % UT <5 % UT
(>95 % dip in UT) (>95 % dip in UT)
for 5 sec for 5 sec
Power frequency 3 A/m Power frequency magnetic fields should be at
3 A/m
(50/60 Hz) levels characteristic of a typical location in a
magnetic field typical commercial or hospital environment.
IEC 61000-4-8
NOTE UT is the a.c. mains voltage prior to application of the test level. In this case 230 V.
IEC 60601
Immunity Test Compliance Level Electromagnetic Environmental - guidance
Test Level
Portable and mobile RF communications
equipment should be used no closer to any part of
the Leisegang Colposcope, including cables, than
the recommended separation distance calculated
from the equation applicable to the frequency of
the transmitter.
Recommended separation distance

⎡ 3.5 ⎤
d =⎢ ⎥ P
3 Vrms 3V ⎣ V1 ⎦
150 kHz to 80 MHz
Conducted RF ⎡ 3 .5 ⎤
3 V/m 3 V/m d = ⎢ ⎥ P 80 MHz to 800 MHz
⎣ E1 ⎦
Colposcopes from
80 MHz to 2.5 GHz
IEC 61000-4-6
⎡7⎤
d = ⎢ ⎥ P 800 MHz to 2.5 GHz
Radiated RF ⎣ E1 ⎦
IEC 61000-4-3 where P is the maximum output power rating of
the transmitter in watts (W) according to the
transmitter manufacturer and d is the
recommended separation distance in meters (m).
Field strengths from fixed RF transmitters, as

determined by an electromagnetic site survey,a
should be less than the compliance level in each
frequency range.b
Interference may occur in the vicinity of

equipment marked with the following symbol:
a
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV
broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic
environment due to fixed RF transmitters, an electromagnetic site survey should be
considered. If the measured field strength in the location in which the Leisegang
Colposcope are used exceeds the applicable RF compliance level above, Leisegang
colposcopes should be observed to verify normal operation. If abnormal performance is
b observed, additional measures may be necessary, such as reorienting or relocating the
Leisegang Colposcope.
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

35348 Rev C. 4/08
Recommended Separation Distance
Recommended Separation Distance between portable and mobile RF communications equipment
and the model Leisegang Colposcope
The Leisegang Colposcope are intended for use in an electromagnetic environment in which radiated
RF disturbances are controlled. The customer or the user of the Leisegang Colposcopes can help
prevent electromagnetic interference by maintaining a minimum distance between portable and
mobile RF communications equipment (transmitters) and the Leisegang Colposcopes as recommended
below, according to the maximum output power of the communications equipment.
Separation distance according to frequency of transmitter
Meters
Rated maximum output power of
transmitter
150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
Watts
⎡ 3 .5 ⎤ ⎡ 3 .5 ⎤ ⎡7⎤
d =⎢ ⎥ P d=⎢ ⎥ P d=⎢ ⎥ P
⎣ v1 ⎦ ⎣ E1 ⎦ ⎣ E1 ⎦
0.01 0.1167 0.1167 0.2333
0.1 0.3689 0.3689 0.7379
1 1.1667 1.1667 2.3333
10 3.6894 3.6894 7.3789
100 11.667 11.667 23.333
For transmitters rated at a maximum output power not listed above, the recommended separation distance d
in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is
the maximum output rating of the transmitter in watts (W) according to the transmitter manufacturer.
For the Leisegang Colposcopes
v1 = 3 Vrms
E1 = 3 V/m
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.

LISEGANG Kolposkop - DFU

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Instruction Manual

35348 Rev C. 4/08

1. Important general references __________________________________________________________________ 5

2 CooperSurgical, Inc. 95 Corporate Drive, Trumbull, CT 06611 USA

4 CooperSurgical, Inc. 95 Corporate Drive, Trumbull, CT 06611 USA

1.1 Preliminary notes

1.2 Determination-Appropriate Use

The device is designed for application in medical practices and/or clinics.

1.2.1 Indications for use

1.2.2 Contraindications for use

Protective Earth (Ground)

Caution: U.S. Federal law

S/N Serial Number

6 CooperSurgical, Inc. 95 Corporate Drive, Trumbull, CT 06611 USA

REF Model or Part Number

LOT Lot Number

1.3 How to read these operating instructions

Symbol meanings are as follows:

8 CooperSurgical, Inc. 95 Corporate Drive, Trumbull, CT 06611 USA

2.1 List of Warnings

2. Do not use extension cords.

5. Use only an authorized LEISEGANG base with your LEISEGANG colposcope.

7. Do not lean on the device.

8. Do not operate the device in an explosive-endangered environment.

10 CooperSurgical, Inc. 95 Corporate Drive, Trumbull, CT 06611 USA

A declaration of conformity from LEISEGANG Feinmechanik-Optik GmbH, as well as full test

LEISEGANG colposcopes model 1DS, 3MS, 3MLS, 1DL-LED, 3MTL-LED,

3.3 Quality management

LEISEGANG Feinmechanik-Optik GmbH Company has an established quality management system

LEISEGANG Feinmechanik-Optik GmbH

4. Short Product Overview

• Convergent viewing beam paths correspond

parallel mode, focus precisely on one

Convergent Unaided Eye Parallel

12 CooperSurgical, Inc. 95 Corporate Drive, Trumbull, CT 06611 USA

D = Rotary drum change-over for observation magnification

COOPERSURGICAL INC., TRUMBULL, CT 06611 USA.

14 CooperSurgical, Inc. 95 Corporate Drive, Trumbull, CT 06611 USA

6.1 Equipment overview, installation and operation

6.2 Scope of delivery and testing of the supplied goods

Possibly associated with the scope of delivery:

Model 1DL (1DS)

OptiK™ Model 1 (1DL-LED)

OptiK™ Model 1 (1DL-LED)

16 CooperSurgical, Inc. 95 Corporate Drive, Trumbull, CT 06611 USA

OptiK™Model 2 (3MTL-LED, 3MVL-LED USB, 3MVL-LED Y/C)

6.6 General Adjustments

18 CooperSurgical, Inc. 95 Corporate Drive, Trumbull, CT 06611 USA

6.6.2 Vertical and Horizontal fine adjustment

The most used adjustments are the horizontal and vertical

1 Turning this handle results in a vertical movement of the

2 Turning this handle results in a horizontal movement of the

3 Inclining this handle results in the tilt of

6.6.3 Compensation of ametropia

Every LEISEGANG colposcope has individual adjusting

6.6.4 Drum Magnification Dial

6.6.5 Focusing the Leisegang Colposcope

6.6.6 Green filter

20 CooperSurgical, Inc. 95 Corporate Drive, Trumbull, CT 06611 USA

6.7.1 Fine height adjustment

1.) Bring the scope in a higher position

2.) Shift the metal cover with type label up

3.) Tighten the screws a little bit until it is fixed enough