Leisegang Colposcopy And Cryosurgery Systems User Manual

Colposcopy and Cryosurgery Systems

Product Information: Colposcopes & Associated
Equipment

What is colposcopy?

Colposcopy is a medical examination of the vagina and cervix to
detect preinvasive and invasive epithelial changes in the genital
tract.

Six good reasons for choosing LEISEGANG

  1. Manufacturing Production: Leisegang colposcopes are 100%
    manufactured in the factory, with a large proportion of skilled
    craftsmanship performed in Berlin/Germany.
  2. Convergent Optics: Leisegang offers convergent optics for
    fatigue-free work. Convergent optics have the advantage that the
    light beams coincide at a working distance of 300 mm, and thus the
    eye does not have to focus on this distance on its own.
  3. Ergonomic Design: Decades of experience and a well thought-out
    design contribute to user-friendly handling and a streamlined
    structure. Ergonomically mounted adjustment drives for height,
    focus, and angle tilting allow the colposcope to be positioned with
    accuracy to the exact millimeter.
  4. LED Lighting: All Leisegang colposcopes are equipped with
    continuously adjustable white-light LED lighting. A higher light
    intensity allows a clearly superior contrast, resulting in precise
    optical imaging.
  5. Stands: Leisegang offers stands that provide stability and
    flexibility for optimal positioning during examination.
  6. Associated Equipment: Leisegang provides additional equipment
    such as cameras, software for documenting images, videos, reports,
    and integration into existing IT solutions in hospitals or private
    practices.

Colposcopes

Leisegang colposcopes provide a three-dimensional image thanks
to their excellent optics, various levels of magnification, and
first-class illumination, enabling optimal non-contact observation
of the external tissue and early detection of pathological
changes.

Stands

Leisegang offers stands that provide stability and flexibility
for optimal positioning during examination.

Associated Equipment

Leisegang provides additional equipment such as cameras,
software for documenting images, videos, reports, and integration
into existing IT solutions in hospitals or private practices.

MediaWorkStation

MediaWorkStation is a software solution provided by Leisegang
that allows users to document images, videos, reports, and
integrate them into existing IT solutions in hospitals or private
practices.

Quick Finder

Quick Finder is a feature provided by Leisegang that allows
users to quickly find relevant information about the product.

Contact Partner

Leisegang provides contact information for customers to get in
touch with a sales representative for any questions or concerns
about the product.

Intended Use

Leisegang colposcopes are intended for use by healthcare
professionals for the examination of the vagina and cervix to
detect preinvasive and invasive epithelial changes in the genital
tract.

Product Usage Instructions

To use the Leisegang colposcope, follow these steps:

  1. Position the stand in a stable location.
  2. Adjust the height, focus, and angle tilting using the ergonomic
    fine adjustments to position the colposcope accurately to the exact
    millimeter.
  3. Turn on the LED lighting and adjust the intensity for optimal
    contrast.
  4. Place the colposcope near the patient and position it for
    optimal observation of the external tissue.
  5. Use the various levels of magnification to observe the tissue
    and detect any pathological changes.
  6. Document images, videos, and reports using the MediaWorkStation
    software provided by Leisegang.
  7. Contact a sales representative using the contact information
    provided by Leisegang for any questions or concerns about the
    product.

COLPOSCOPES & ASSOCIATED EQUIPMENT

Dr. Thomas Kupferschmidt Head of Sales
Dear Customers,
Leisegang is a long-established German company that was founded over 120 years ago. Since 1947, Leisegang has specialized in the manufacture of colposcopes, and over the years has become one of the world’s market leaders in this field. The use of high-quality optics, the use of white-light LED lighting, and a high degree of hand-finished manufacturing all contribute to the outstanding quality that is essential for accurate diagnosis in gynecological consultations. This is why Leisegang colposcopes are known worldwide as the ,,Gold Standard” in colposcopy and are currently exported to more than 80 countries worldwide. As a subsidiary of the American CooperSurgical Group, we can bundle all products related to dysplasia consultations and thus offer you expertise from a single source.
Thank you for your trust Your Leisegang Team
2

Table of Contents

What is colposcopy?

3

Six good reasons for

choosing LEISEGANG

4

Colposcopes

8

Stands

11

Associated equipment 15

MediaWorkStation

20

Quick Finder

22

Contact Partner

24

What is colposcopy?

A brief introduction to our products

Colposcopy first emerged in the 1920s. In 1925, the German physician Hans Hinselmann examined and classified epithelial changes and thus invented colposcopy, which translates as ,,vaginal examination” (Greek: ,,kolpos” = vagina; ,,skopia” = examination). Hinselmann thus made a decisive contribution to the early detection of cervical cancer.
Colposcopy still plays a crucial role in the early detection of preinvasive and invasive epithelial changes in the genital tract: l Cervical cancer is considered the second leading cause of
death in women worldwide; l More than half a million women are diagnosed with this
cancer each year worldwide; l Half of them will die as a result.
Cervical cancer can be cured if detected early. The quality of the colposcope is of critical importance. Leisegang colposcopes provide a three-dimensional image thanks to their excellent optics, various levels of magnification and first-class illumination, thus enabling optimal non-contact observation of the external tissue and early detection of pathological changes.

The range of colposcopes offered is extensive and includes everything from simple standard colposcopes with several magnification levels to photo/video colposcopes with an externally connectable camera. Optimal associated equipment such as documentation software and hardware broaden the application capabilities. As a modular system, Leisegang colposcopes and the corresponding hardware and software components facilitate an introduction to digital colposcopy with the option of integration into existing IT solutions via GDT or DICOM interfaces (Digital Information and Communication in Medicine).
Our customers can use their colposcope – as they know it from ultrasound or sonography – as an ,,Imaging Modality”: From a colposcope head with an HD camera, user-friendly software for documenting images, videos, reports all the way to integration into the already existing IT solutions in hospitals or private practices. Leisegang colposcopes comply with medical and technical quality requirements, guidelines and regulations.

Intended Use

Leisegang colposcopes are used in gynecological examinations for magnified, non-contact viewing of the external female genitalia (vulva, vagina, cervix). However, colposcopes can also be used for magnified, non-contact viewing of other external organs. Leisegang photo/video colposcopes with externally connected cameras can also be used to document findings. Leisegang colposcopes are used exclusively for optical imaging. For a final analysis, Leisegang Feinmechanik-Optik GmbH recommends using cytological findings.

3

Six good reasons for choosing LEISEGANG
1 Manufacturing Production
Leisegang colposcopes are 100 % manufactured in the factory, with a large proportion of skilled craftsmanship performed in Berlin/Germany.

Parallel optical beam path

Naked eye

Convergent beam path

Comfortable colposcopy with or without glasses

2 Convergent Optics
Unlike the parallel optics commonly available on the market, Leisegang offers convergent optics for fatigue-free work. Convergent optics have the advantage that the light beams coincide at a working distance of 300 mm, and thus the eye does not have to focus on this distance on its own.
3 Ergonomic Design
Decades of experience and a well thought-out design contribute to user-friendly handling and a streamlined structure. Ergonomically mounted adjustment drives for height, focus and angle tilting allow the colposcope to be positioned with accuracy to the exact millimeter. Detachable rings for eyepiece caps make colposcopy possible even with eyeglasses.

Ergonomic fine adjustments for height, focus and tilt

4

4 LED Lighting
All Leisegang colposcopes are equipped with continuously adjustable white-light LED lighting. A higher light intensity allows a clearly superior contrast, resulting in precise optical imaging. Leisegang provides an extremely bright LED spotlight with a illumination intensity between 45,000 and 52,000 lux at a working distance of 300 mm.
5 Comfortable Stands
Whether mobile or permanently fixed to an examination chair, Leisegang stands are distinguished by ease of use and low space requirements. A slim, sophisticated design ensures reliable stability and allows for maximum possible movement for accurate positioning.
6 Durability
Leisegang colposcopes feature an impressive service life, and there is also no need to change lamps. It’s an investment that will pay off.

Even today, these devices are still in use in doctors` offices:

Model II ­ from the 1960s

Model I A ­ from the 1970s

Model III b ­ from the 1980s

5

Six good reasons for choosing LEISEGANG

Selected references:
Germany
Universitätsklinik Hamburg-Eppendorf Katholisches Klinikum Mainz Helios Klinikum Berlin-Buch Ernst von Bergmann Klinikum, Potsdam Universitätsklinikum Tübingen

Dr. Shakuntala Baliga India
“Leisegang is one of the oldest and among the best manufacturers of precision instruments in the world. The Leisegang colposcope is considered the “Gold Standard” by the industry and by doctors. The software is very suitable for doctors for everyday use.”

International
Johns Hopkins Hospital, Baltimore, USA Yale University ­ New Haven, CT, USA Chu Bichat-Cl. Bernard, Paris, France Perinatal Center of Bakulevs Institute, Moscow, Russia University Hospital, Kuala Lumpur, Malaysia National Cancer Institute, Bangkok, Thailand Beijing University People`s Hospital, Beijing, People’s Republic of China Gandhi Hospital, Secunderabad, India

Dr. Quek Swee Chong Singapore
“I have been using Leisegang colposcopes for the last 10 years and am very pleased with their performance. As a colposcopist who works in a variety of clinical settings, ranging from large tertiary institutions to rural villages, it is important to have a colposcope that I can rely on to deliver outstanding image quality. The Leisegang colposcopes I have used have never failed me. These colposcopes are distinguished by their ease of use, ergonomics, ruggedness and most importantly, their superb optics.”

6

Colposcopes
All Leisegang colposcopes have the following features: l Convergent beam path for fatigue-free
operation l Vivid, 3D image l 300 mm working distance l LED lighting:
With a color temperature of 5,700­6,000 Kelvin for excellent contrast, with an illumination intensity of 45,000­ 52,000 Lux (at a working distance of 300 mm), only 10 W power consumption, the lamps have a long lifetime and therefore do not need to be replaced, continuously variable adjustment l Green filter for observation of blood vessels1 l Compensation for myopia and hyperopia through adjustable eyepieces l Standard color gray white (RAL 9002); also available in all colors within the RAL color system l All Leisegang colposcopes are Class I medical devices
1 Excluding angle devices
7

Convergent optics with LED light for fatigue-free operation
8

3 2

Standard Colposcopes

The standard model for day to day consultations with various magnification settings, green filter, continuously adjustable LED lighting, dioptric correction from +7 to ­7 diopters and a working distance of 300 mm.

1E LED

1D LED

2′

3′ 1′
1

All Leisegang colposcopes have fine adjustment drives for l Height (1) l Focus (2) l and tilt angle (3)

Entry level model for everyday consultations: l X15 fixed magnification l Adjustment drives for focus and height

Standard device with three magnification levels:
l Magnification changer for x 7.5-/15-/30 magnification
l Adjustment drives for focus and height
l 1DS LED As for 1D LED, but with x 3.75/7.5/15 magnification

Fixed magnification x 15

X 3.75/7.5/15 magnification 9

Photo/video colposcopes

Colposcopes for users with more advanced requirements such as documentation or presentation of the examination image on a monitor. Highly dimmed lenses allow for a large depth of focus.

1DW LED

3ML LED

3MLW LED

As for 1D LED, but with comfortable 45° angled view: l Magnification changer for
x 7.5-/15-/30 magnification l Note: no green filter!
x 7.5-/15-/30 magnification

Photo/video colposcope for the documentation of examination results. Intended for the connection of external cameras:
l Magnification changer for x 7.5-/15-/30 magnification
l Integrated mono photo/video optics with the appropriate magnification
l Digital SLR camera or video camera can be connectedr
l 3MLS LED 1″ Like 3ML LED, but with x 3.75/7.5/15 magnification; for cameras with 1″ chip size
l 3MLS LED 1/2″ Like 3ML LED, but with x 3.75/7.5/15 magnification; for cameras with 1/2″ chip size

Like 3ML LED, but with comfortable 45° angled view.
l Magnification changer for x 7.5-/15-/30 magnification
l Note: no green filter!

Convenient mounting of cameras via the camera port:
10

Stands
Leisegang offers various types of stands, which can be either mobile or fixed to the gynecological examination chair. They are characterized by an ease of use and a low space requirement.
All Leisegang stands are accessories for colposcopes and also Class I medical devices.

Stands
Balance-o-matic stand
Comfortable works due to “weightless,” free movement: l Free horizontal movement within a
radius of up to 600 mm l Space-saving due to foldable frame
(radius when folded: 300 mm) l “Weightless” vertical movement due
to balanced, an effortless movement system l Lockable l Fixed mounting to examination chairs on the right or left is possible l Five-wheel spider base allows for stand mobility l A later conversion from chair to roller foot mounting is possible

600 mm 300 mm

860 mm
750 mm
12

min. 850 mm max. 1410 mm

Stands
Swing-o-matic stand
Solid design with low space requirement: l Free horizontal movement within a
radius of up to 600 mm l Space-saving due to foldable frame
(radius when folded: 300 mm) l Vertical movement through manual
adjustment and height drive l Fixed mounting to examination chairs
on the right or left is possible l Five-wheel spider base allows for
stand mobility l A later conversion from chair to roller
foot mounting is possible

600 mm 300 mm

800 mm 750 mm

min. 860 mm max. 1260 mm
13

Stands
Upright Stand
Robust basic model: l Rigid column with light weight
5-wheeled spider base l Working height: 970­1090 mm

Special finish
All Leisegang colposcopes and stands are also available with special painting in all RAL colors.

14

Associated equipment
Leisegang purchases associated equipment from third-party suppliers to supplement its systems. The associated equipment supplied may differ from the illustrations shown due to technical developments and changes.
15

Associated equipment
Associated equipment for the documentation of findings.

Video camera
Compact Video Camera: l 1.3 MegaPixel resolution l CCD image sensor l C-mount lens mount l USB 2.0 port l For connection to PC l Immediate availability of the images l Simple connection via video tube

Canon EOS
Digital SLR camera from Canon with extremely high resolution. In addition to everyday office work, also suitable for scientific publications and presentations: l 24 MegaPixel resolution l CMOS image sensor l Full HD-Movies l For connection to PC l Easy connection via photo tube and T2 adapter l T2 adapter included in the scope of delivery l Canon lens not included in scope of delivery; photo tube
must be ordered separately

16

Panel PC with touch screen
Particularly sleek, completely enclosed Panel PC l Convenient touch operation, with on-screen keyboard l Hygienic design l Full HD display with wide viewing angle l IP20

IMAGING MODALITY
As a modular system, Leisegang colposcopes and the corresponding hardware and software components offer an entry into digital colposcopy with the possibility of integration into existing IT solutions via GDT and/or DICOM. Our customers can use their colposcope, as they know it from ultrasound or sonography, as an ,,imaging modality”:
From a colposcope head with an HD camera, user-friendly software for documentation with images, videos and reports, to integration with existing IT solutions in hospitals or private practices.

This is how MediaWorkStation simplifies the management of your image and video data
l User-friendly Easy to record, save, and retrieve footage with intuitive user interface
l Adjustable The software interface is customizable and available in multiple languages
l Secure Unique assignment of images to the selected patient dataset, automatic database backup

We are available to discuss a custom solution for your
requirements!

17

Cart light Duty
l For adding a tablet, panel PC or something else l With VESA plate or similar l Five-wheel spider base for stand mobility l Optional: with grip bar, tray and basket

Cart heavy Duty
l For the inclusion of a panel PC or something else l With VESA plate or similar l Heavy five-wheel spider base for stand mobility l With grip bar and printer tray

Keyboard
The alternative to the touchscreen
l Wireless, cordless keyboard with integrated touchpad, language: German
l Fully enclosed surface made of ,,Gorilla” glass, washable and sanitizable (IP65 front side)
l USB port
l Incl. Bluetooth dongle, charging cable and charging plug with 4 adapters

Footswitch
l 2 pedals l USB connection l Cable length 3 m

18

19

MWS MediaWorkStation effortless documentation and archiving
MediaWorkStation organizes your imaging and video footage easily and efficiently. The software has been optimized for colposcopy in collaboration with leading international gynecologists. The result is a particularly intuitive user interface that ensures uncomplicated workflow.
Recording
l Recording of single images and video sequences
l Preview with split display for live and single image recording
l Control via software, camera shutter release or footswitch
Commenting
l Input of free text or text modules l Text modules based on the current
IFCPC nomenclature for colposcopy (,,Rio de Janeiro,” 2011) l Insertion of graphic markers l Mapping of colposcopic and histological findings
Exporting
l Export as file, images with embedded patient indicators
l Direct printing of images with embedded patient identification
l HTML reports with images and patient data
Database
l Structured archiving in a database l Free text search l Automatic backup of database
20

An integrated image atlas supports the diagnosis as a reference aid. A DICOM Push and a DICOM Worklist interface are available as options. MediaWorkStation Software is a Class I medical device. Available language versions: German, English, French, Italian, Spanish, Russian, Turkish, Chinese
NOTE: For chair assembly, a load capacity of at least 32 kg is required
21

Quick Finder

Standard Colposcopes

Model
1E LED 1D LED 1DS LED 1DW LED

Magnification

LED lighting

Fine adjustment drives for focus and height

15x 3,75/7,5/15x 7,5/15/30x

l

l

l

l

l

l

l

l

Height Focus Tilt

l

l

l

l

l

l

l

l

l

l

l

l

45° angled view
l

Green filter

Dioptric compensation ± 7 diopters

l

l

l

l

l

l

l

Photo/video colposcopes

Model

Magnification

LED lighting

Fine adjustment drives for focus and height

3,75/7,5/15x

3ML LED

3MLS LED 1″

l

3MLS LED 1/2″

l

3MLW LED

7,5/15/30x
l
l

Height Focus Tilt

l

l

l

l

l

l

l

l

l

l

l

l

l

l

l

l

45° angled view
l

Green filter

Dioptric compensation ± 7 diopters

l

l

l

l

l

l

l

Cameras
Model
Video camera Canon EOS

Resolution

1,3

24

MP

MP

l

l

Mounting External
l l

Live Video
l l

For which colposcope

3ML

3MLW

3MLS

LED

LED

LED

l

l

l

l

l

l

Stand Compatibility
Model
Upright stand with lightweight spider base (BG000131) Swing-o-matic stand with spider base column (BG001530) Swing-o-matic stand with short column, for chair assembly, among others Schmitz chair (BG000170) Swing-o-matic stand without column, for chair assembly (BG000160) Swing-o-matic stand with long column, among others for examination tables (BG000180) For special uses: Please contact us Balance-o-matic stand (BG000135)

Light Heavy 5-whee- Special assembly Special assembly Special assembly Atmos

spider led spider base Maquet Radius Maquet Radius Chair Gyne (Baisch) chair

base (B0001500) chair (BG001010) chair (BG001020)

(B0001010)

l

l

l

l

l

l

l

22

23

Contact Partner

Dr. Thomas Kupferschmidt Senior Director Business Development Cooper Surgical and Leisegang Head of Sales Authorized signatory Tel. +49 30-31 90 09-0 E-mail [email protected]
Falko Sandmann Head of Quality Management Tel. +49 30-31 90 09-31 E-Mail [email protected]
Barbara Breitfeld Sales / Customer Service Tel. +49 30-31 90 09-34 E-Mail [email protected]
Ingo Hampe Sales / Marketing Tel. +49 30-31 90 09-46 E-Mail [email protected]
Mustafa Sakrak Technical Service Tel. +49 30-31 90 09-0 E-Mail [email protected]

Leisegang Feinmechanik-Optik GmbH

Leibnizstraße 32

D-10625 Berlin, Germany

Telefon +49-(0)30-319009-0

Fax

+49-(0)30-3135992

E-Mail [email protected]

Internet http://www.leisegang.de

a CooperSurgical company

Managing Directors: Uwe Skirl, Kerry Blair

Regulatory and legal information: Leisegang colposcopes are Class I Medical Devices according to Annex IX of the 93/42/EEC Medical Devices Directive. In a conformity assessment procedure in accordance with Annex VII of the Medical Device Directive, Leisegang Feinmechanik-Optik GmbH has demonstrated that Leisegang colposcopes fulfill the essential requirements of Annex I of the Directive. To demonstrate compliance with these requirements, the devices are marked with a CE mark.
Copyright: ®, TM, etc. The product and company names mentioned may be trademarks or registered trademarks of their respective owners.
All technical and design changes reserved.
For more information, visit our website: simply scan the QR code using a smartphone and a QR code app.

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Doc. No.: K0000671 Revision:11.0 Date of issue: 09.2022

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