Cooper Surgical Leisegang OptiK 1 User manual

Leisegang Colposcopes and Accessories
Instructions for Use
English
All rights reserved. No part of this work may be reproduced in any form without written permission from CooperSurgical, Inc.
OPTIKCOLPO-IFU • Rev.C • 07/22

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Table of Contents
Table of Contents
1 Important General References 4
1.1 Appropriate Use 4
1.1.1 Indications for Use 4
1.1.2 Contraindications 4
1.2 Symbols 5
1.3 How to read these Operating Instructions 5
2 Important Notes on Safety 6
2.1 List of Warnings 6
3 Certifications 7
3.1 CE Certification 7
3.2 UL Certification 7
4 Short Product Overview 8
5 Guarantee 10
6 Colposcopes 11
6.1 Equipment Overview, Installation and Operation 11
6.2 Scope of Delivery and Testing of the Supplied Goods 11
6.3 Standard Colposcopes 12
6.4 OptiK™ Model 2 (3MTL LED, 3MVCL LED USB) 13
6.4.1 Camera Adapter 14
6.5 General Adjustments 15
6.5.1 Rough Height Adjustment 15
6.5.2 Vertical and Horizontal Fine Adjustment 16
6.5.3 Compensation of Ametropia 16
6.5.4 Drum Magnification Dial 16
6.5.5 Focusing the Leisegang Colposcope 17
6.5.6 Green Filter 17
6.6 Do-It-Yourself Troubleshooting 18
6.6.1 Fine Height Adjustment 18
6.6.2 Hold Adjustment for Fine Focus 19
6.6.3 Fuses 19
7 Stands 20
7.1 Swing Stand 20
7.1.1 Swing Stand Assembly 21
7.2 The Balance-o-Matic Stand 21
7.2.1 Balance-o-Matic Stand Assembly 22
7.3 Tilt Stand and Upright Stand (Roller Base) 23
7.4 Installations 25
7.4.1 Installation of Swing Stand on Mobile 5-Wheel Roller Base 25
7.4.2 The Balance-o-Matic Stand on Mobile 5-Wheel Roller Base 26
8 Power Supply 27
8.1 LED-Lighting 28

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Table of Contents
9 Accessories 29
9.1 Video Adapters 29
9.1.1 Mounting Video Adapters 29
9.2 Camera 30
10 Care and Maintenance 31
10.1 Disinfection 31
11 Replacement Wear Parts and Technical Service 33
11.1 Technical Service 33
11.2 Spare and Worn Parts 33
11.2.1 Lamp Change 33
11.2.2 Fuses 33
12 Technical Data and Notes on Safety 34
12.1 EMC - Electromagnetic Compatibility 34
12.2 Control and Maintenance 34
12.3 Returns, Complaints 34
13 Technical Data 35
13.1 Type Plates 35
13.1.1 Type Plate Colposcope Head 35
13.1.2 Type Plate Power Supply 36
13.2 Classification 36
13.3 Safety Class 36
13.4 General 37
13.5 Devices with magnification 3.75x/7.5x/15x 37
13.6 Environment Conditions 38
13.7 Dimensions and Weights 38
13.8 Electrical Connections 39
13.9 Power Consumption 39
13.10 Lamps 39
13.11 LED Light Specification 39
13.12 Leisegang Colposcopes EMC Compliance Information 39
13.13 Electromagnetic compatibility 40
Table 1 Guidance and Manufacturers Declaration-Electromagnetic
Radiation 40
Table 2 Guidance and Manufacturers Declaration Electromagnetic
Immunity 41
Table 3 Guidance and Manufacturers Declaration Electromagnetic
Immunity 42
Table 4 Recommended Separation Distance 43
13.14 Model number 44

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Important General References
1 Important General References
Device Description
The Cooper Surgical Leisegang Colposcopes and accessories are optical devices designed for non
contact visualization of the tissues of the cervix, vulva, vagina, and anogenital areas. Depending on the
model and/or mode selected, they provide direct visual, photographic, and/or high resolution color
imaging of the selected area.
1.1 Appropriate Use
Only Leisegang accessories, bases, sources of light and camera equipment may be utilized with
Leisegang colposcopes.
Restrictions, which are stipulated in the Instructions for Use, are to be considered.
The device is designed for application in medical practices and/or clinics. The devise is not intended to be
used in locations with MRI, CT, diathermy, RFID, and electromagnetic security systems such as metal
detectors.
Colposcopes should only 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.
1.1.1 Indications for Use
The Cooper Surgical Leisegang Colposcope Systems are intended for the magnified viewing of the tissues
of the vagina, cervix, and external genitalia in order to assist doctors in diagnosing abnormalities such as
lesions or cancer and selecting areas for biopsy.
The images from Cooper Surgical Leisegang Colposcope Systems may be viewed directly and/or on a
color monitor (if so equipped). The Cooper Surgical Leisegang Colposcope Systems are intended for use
in hospitals, clinics, and doctor’s offices.
1.1.2 Contraindications
The Cooper Surgical Leisegang 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.
Federal Law (USA) restricts this device to the sale by, or on the order of, a Physician!

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Manufacturers
address
Consult accompanying documents /
Instructions for use
Protection Class II
Date
of
Manufacture
Type B applied part
IP20
Ingress protection rating
Serial number of the product
Symbol indicates that the device
should be sent to the special agencies
according to local regulations for
separate collection after its useful life
Authorized
European
Representative
Model
or
part
num
ber
of
the
product
Quantity
Lot
number
Electromagnetic interference
can
occur in the vicinity of devices
carrying this symbol
The product complies with US and
Canadian safety requirements.
LOT
REF
Important General References
1.2 Symbols
Symbol Meaning Symbol Meaning
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:
SN
REP
EC
QTY
i
Installation: The delivery of the goods dispatched from Leisegang always includes the
tools needed for the installation, such as screwdrivers, Allen keys, etc.
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.
Warning: Important notes on safety. Pay close attention to the information and details
provided here, in order to avoid personal injury or device damage.
Meaning Symbol

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Important Notes on Safety
2 Important Notes on Safety
2.1 List of Warnings
1. 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. Use only an authorized Leisegang base with your Leisegang colposcope.
5. Do not hang any additional objects on the colposcope or on parts of the base.
6. Do not lean on the device.
7. Do not operate the device in an explosive endangered environment.
8. Defective cables or plugs can cause electrical accidents and fires. Replace defective cables
immediately or call an authorized technician.
9. Do not use power supply units with damaged cases. Contact CooperSurgical for a replacement.
10. The mains cable (wired plug) should never be removed at the cable connection end, but always at the
plug socket only.
11. 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.
12. Do not roll the device over deep-pile carpets or over objects on the floor (cables, hoses).
13. Never set up or operate the device on rough or tilted surfaces.
14. Except for the components described in these Instructions 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.
15. CooperSurgical / Leisegang is not liable for damages resulting from improper use of their products or
contraventions against safety notes mentioned above.
16. 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.
17. No modification of this equipment is allowed.
18. No Customer serviceable parts. Only replacement of eyepiece rings, light guides fuses, power cords
or fuses can be done by the user. Only replace with these items with the exact replacement part[s]
available from Leisegang.
19. Position the Colposcope to maintain access to the power outlet it is plugged into to assure ease of
disconnection from the power source if needed. To remove all power from the Colposcope, disconnect
the power cord from the wall outlet.
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.

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Important Notes on Safety
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 through Friday,
8:30 AM to 5:00 PM E.S.T. CooperSurgical, Inc.
95 Corporate Drive
Trumbull, CT 06611 USA
Phone: [phone]
Fax: [phone]
International
Phone: [phone]
Fax: [phone]
e-mail: [e-mail]
Internet: http://www.coopersurgical.com
3 Certifications
3.1 CE Certification
The device is tested according to the specifications of the European Medical Device Regulation [MDR
EU] 2017/ 745, dated 5th May, and fulfills the necessary standards concerning the MPDG
(Medizinprodukterecht - Durchführungsgesetz / Medical Devices Law Implementation Act). 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
14MY
The following Leisegang products meet the requirements of the IEC 6060-1 3rd edition: AAMI/ANSI ES
60601-1, IEC 60601-1-2: 2007; IEC 60601-2-41:2009; and CAN/CSA C22.2 NO. 60601.1:08:
Models: 1DL-LED [OPTIK1-XX in USA], 3MVCL -LED [OPTIK2-1X & OPTIK2-1X-XXX in USA], 3MTL-LED
[OPTIK2-0X & OPTIK2-0X-XXX in USA], 1E-LED, 1D- LED, 1DS-LED, 1DW-LED, 3ML-LED, 3MLS-LED
1”, 3MLS-LED 1/2”, 3MLW-LED, 3MVC-LED USB, 3MVCW-LED USB, 3MVCS-LED USB.
LEISEGANG COLPOSCOPES
MEDICAL EQUIPMENT WITH RESPECT TO ELECTRICAL SHOCK, FIRE AND MECHANICAL
HAZARD ONLY IN ACCORDANCE WITH THE STANDARDS LISTED BELOW.

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Short Product Overview
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.
• 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 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.
Optical Beam Path
• 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.
Convergent Unaided Eye Parallel

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Short Product Overview
• 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 (3.75x) to a high power (7.5x), 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.
Par Focal*
3.75X
In focus
In focus
In focus
15X
In focus
• 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 = 3.75/7.5/15x 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, 3MVCL-LED-USB) 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.

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Guarantee
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 Instruction for Use 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 Instructions for Use and related written materials are trademarked or
copyrighted 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 Instructions for Use and other written materials provided to
Licensee with the Product are acknowledged.
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, AC-CURACY, 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.