Leisegang 1E LED User manual

Colposcopes and Stands
1E LED
1D LED
1DW LED
1DS LED
3MVC LED USB
3MVCS LED USB
3MVCW LED USB
3ML LED
3MLW LED
3MLS LED 1"
3MLS LED 1/2"
Instructions for Use
English

Publication details
Copyright ©LEISEGANG Feinmechanik-Optik GmbH 2013-2021.
All rights, delivery availability and technical changes reserved.
Issued by:
LEISEGANG Feinmechanik-Optik GmbH
Leibnizstrasse 32
D-10625 Berlin
Tel.: [phone]
Fax: [phone]
E-Mail: [e-mail]
www.leisegang.de
Please read the instructions and information in the Instructions for Use carefully before
using the device.

Contents
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Contents
Purpose............................................................................................................. 5
1.1 Intended use ......................................................................................................................5
1.2 Indications and field of application.....................................................................................5
1.3 Users and application environment....................................................................................6
1.4 Patient population .............................................................................................................6
1.5 Contraindications ...............................................................................................................6
1.6 Side-effects......................................................................................................................... 6
1.7 Clinical benefits ..................................................................................................................6
1.8 Performance characteristics ...............................................................................................6
1.9 General user information ...................................................................................................7
1.10 Safety instructions..............................................................................................................7
1.10.1 Meaning of symbols in these instructions.................................................................. 7
1.10.2 Meaning of symbols on the device and outer packaging ........................................... 7
1.10.3 Precautions and safety information ........................................................................... 8
Marketability .................................................................................................. 10
2.1 Manufacturer ................................................................................................................... 10
2.2 Medical device and market placement............................................................................. 10
2.3 Warranty information ...................................................................................................... 10
2.4 Reporting of serious incidents .......................................................................................... 11
Device description........................................................................................... 12
3.1 Essential features ............................................................................................................. 12
3.2 Colposcope....................................................................................................................... 12
3.3 Stands .............................................................................................................................. 15
Technical data ................................................................................................. 17
4.1 General information......................................................................................................... 17
4.2 Power supply.................................................................................................................... 17
4.3 Standard colposcopes....................................................................................................... 18
4.4 Photo/video colposcopes ................................................................................................. 20
4.5 Stands .............................................................................................................................. 22
4.6 5-wheeled spider base...................................................................................................... 23
4.7 Model number ................................................................................................................. 24
4.8 Electromagnetic compatibility.......................................................................................... 25
Transport and storage ..................................................................................... 29
5.1 Storage ............................................................................................................................. 29
5.2 Disposal of packaging material ......................................................................................... 29

Contents
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Operation........................................................................................................ 30
6.1 Preparing the colposcopy ................................................................................................. 30
6.1.1 Performing height adjustments................................................................................ 30
6.1.2 Performing a dioptric correction .............................................................................. 32
6.1.3 Using a colposcope with glasses............................................................................... 33
6.1.4 Adjusting focus of eyepieces .................................................................................... 33
6.1.5 Setting up working distance ..................................................................................... 34
6.2 Using a colposcope ........................................................................................................... 35
6.2.1 Performing fine adjustments.................................................................................... 35
6.2.2 Swing in the green filter ........................................................................................... 36
6.2.3 Adjusting magnifications .......................................................................................... 36
6.2.4 Determining the lesion size ...................................................................................... 37
Care, maintenance, inspection......................................................................... 38
7.1 Care and disinfection........................................................................................................ 38
7.2 Maintenance .................................................................................................................... 40
7.3 Inspection, repeat tests.................................................................................................... 40
Repair ............................................................................................................. 40
Customer service............................................................................................. 41
Disposing of waste equipment......................................................................... 42
Glossary .......................................................................................................... 43
Keyword index ................................................................................................ 44

Purpose

Intended use
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Purpose
1.1 Intended use
Leisegang colposcopes are used in gynecological examinations to provide enlarged, non-
contact view of the outer female genitalia (vulva, vagina, portio) in the visible area. The
colposcopes can also be used for enlarged, non-contact viewing of other external organs.
Leisegang photo/video colposcopes with an integrated or externally connected camera can
also be used to document the findings.
Leisegang colposcopes are only used to aid in the diagnosis. In any case, further findings are
to be consulted.
1.2 Indications and field of application
Leisegang colposcopes are used in gynecological examinations for magnified, non-contacting
viewing of the external female genitalia (vulva, vagina, portio).
The device is intended for use in medical practices and clinics. The device is suitable for use
in the operating theatre, but not for use in locations with MRI, CT, diathermy, RFID and
electromagnetic security systems such as metal detectors.
The colposcope is intended for multiple uses. Chapter 7.1 Care and disinfection describes
information about cleaning and disinfection.
Colposcopy – cytological findings:
•Suspicion of carcinoma
•Suspicion of low or high-grade dysplasia (deviation of the tissue structure from the normal
image)
•Glandular atypia (glandular, possibly inflammatory epithelium atypia (deviations from
the norm) that do not fulfil the criteria for dysplasia)
•Unclear findings from cytological smears (Pap smear, thin-layer cytology)
•Conspicuous smears in patients under immunosuppression (suppression of the body's
own defenses), e.g. due to HIV infection or organ transplantation
Colposcopy – other findings:
•Confirmed infection with HPV (Human papillomaviruses: viruses that can cause cervical
cancer)
•Contact bleeding (bleeding on mucosal contact, e.g. following sexual intercourse)
•Persistent vaginal discharge
•Macroscopic conspicuous cervix (changes visible to the naked eye)
•Cervical polyps (benign protrusions of the cervical mucosa)

Purpose

Users and application environment
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1.3 Users and application environment
Users
User group Qualification Activity
End user:
Medical practitioners
(physicians)
Gynecologist Operation of the device
End user:
Medical personnel
Medical training Maintenance of the device
Application environment
Leisegang colposcopes are only intended for use in rooms used for medical purposes.
Observe the local requirements for the electrical installation.
1.4 Patient population
The target patient population for application of Leisegang colposcopes includes adult and
adolescent females, according to the judgment of the healthcare professional, when used at
the anatomical sites as defined in the indications and field of application.
1.5 Contraindications
There are no known contraindications to the use of Leisegang colposcopes.
1.6 Side-effects
There are no known side-effects for the use of Leisegang colposcopes.
1.7 Clinical benefits
Leisegang colposcopes aid in the viewing of the outer female genitalia (vulva, vagina, portio)
for abnormalities or further examination from inconclusive cervical cancer screening tests.
Leisegang colposcopes provide for non-contact view of the outer female genitalia or other
external organs with no invasiveness and allow mobility or minimal interaction with
physician.
1.8 Performance characteristics
When used according to the manufacturer’s instructions for use, Leisegang colposcopes are
intended to provide enlarged, non-contact view of the outer female genitalia (vulva, vagina,
portio) or other external organs in the visible area with no invasiveness and allow mobility or
minimal interaction with the physician.

Purpose

General user information
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1.9 General user information
This manual describes the intended use and operation of Leisegang colposcopes. Assembly
and repair of the colposcopes are described in the assembly and repair manual.
Highlighting
Highlighting Function Example
Italics Reference to other sections or
text passages
Please note the instructions as
listed under Chassis of colposcope
head.
Bold Reference numbers for
illustrations, for emphases
(1)
1.10 Safety instructions
1.10.1 Meaning of symbols in these instructions
Symbol Meaning
Necessary information for the subsequent steps; information and tips.
Safety notice "Caution"
Warns of a danger that can lead to minor physical injuries or damage to
property.
Safety notice "Warning"
Warns of a danger that can lead to serious physical injuries or to death.
1.10.2 Meaning of symbols on the device and outer packaging
Symbol Meaning
Symbol
Meaning
Conformity of the product with
the provisions of the applicable EU
directive (and national laws)
Conformity of the product with US
and Canadian safety requirements
Manufacturer's address Date of manufacture
Serial number of the product Model number of the product
Transport and store dry Fragile; transport and store with
care, do not drop
Permissible humidity range during
transport and storage
Permissible temperature range
during transport and storage
Permissible pressure range during
transport and storage
IP Degree of protection; protection
against the ingress of solid foreign
bodies and water

Purpose

Safety instructions
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Symbol Meaning
Symbol
Meaning
Transport and store with the
arrows always point up
Electromagnetic interference can
occur in the vicinity of devices
labelled this way
Recycling of the packaging
material
Separate disposal of waste
electrical-equipment
Observe Instructions for Use Colposcope Generic device name in accordance
with Global Medical Device
Nomenclature (GMDN)
Alternating current Direct current
Protection class II Medical device
1.10.3 Precautions and safety information
Read the following safety information carefully before installation and use:
•These instructions are part of the device and must be kept throughout the entire
service life of the product.
•Keep these instructions available for reference and pass them on to the next user of
the device.
•Observe the practically-oriented safety instructions in the relevant sections.
•Only use the colposcope with Leisegang stands and Leisegang accessories.
•Dirt and dust can impair the functionality of the device. Therefore protect the device
when not in use with the dust protection cover supplied. Before covering the device,
check that it is switched off.
•There is a risk of crushing when adjusting the height of the colposcope head and
swing-o-matic stand. Therefore, observe the safety instructions in the relevant
sections.
•The connecting tube of the colposcope must always be inserted at least 20 cm in the
stand frame in order to ensure stability.
•Waste electrical and electronic equipment must not be discarded with household
rubbish. Dispose of your old equipment in accordance with national requirements for
separate disposal of waste or return your old device either to your supplier or
Leisegang Feinmechanik-Optik GmbH.
•The device may only be operated in dry rooms without spray water.
•The device must not be operated in an oxygen-saturated environment.
•Set-up the device in a stable position.
•Do not roll the device over cables and tubes on the floor.
•Do not hang any additional objects on the device that are not expressly intended for
this purpose.
•Do not lean against the device.
•Do not cover the cooling slots of the power supply or the cooling slots of the LED light
source. This can cause overheating and damage to the device.
•Position the device in a way to allow easy access to the mains cable.
•Only pull the mains cable from the socket at the plug.

Purpose

Safety instructions
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•Never remove the ferrite beads from the USB cables, since this may cause
electromagnetic interference.
•Do not operate power supplies, mains cables, lamp cables or mains plugs with
mechanical damage. Defective parts must be replaced by qualified, authorized
specialist personnel. Contact your supplier in this regard.
•Do not undertake any modifications, as otherwise safe operation of the device is not
guaranteed and all guarantee and warranty claims towards Leisegang Feinmechanik-
Optik GmbH are void.
•Always unplug the device before changing the fuse and before cleaning the device.
•The power supply is not drip or splash-proof. The ingress of water results in an
electric shock. For this reason, when cleaning the device ensure that no dripping
water comes into contact with it. No infusion devices, e.g. infusion bags, bottles and
lines may be installed above the colposcope that entail a risk of dripping.

Marketability

Manufacturer
10 / 46
Marketability
2.1 Manufacturer
LEISEGANG Feinmechanik-Optik GmbH
Leibnizstr. 32
10625 Berlin
Tel: [phone]
Fax: [phone]
E-Mail: [e-mail]
2.2 Medical device and market placement
Leisegang colposcopes are class I medical devices according to Annex VIII, Chapter III of
Regulation (EU) 2017/745 of 5 April 2017.
Leisegang Feinmechanik-Optik GmbH has demonstrated in a conformity assessment
procedure according to this medical device regulation that Leisegang colposcopes and their
accessories meet the basic safety and performance requirements of the regulation
mentioned above.
The devices bear the CE mark to indicate compliance with these requirements. A copy of the
Declaration of Conformity, which is issued under Annex IV of the Medical Devices Ordinance,
can be enclosed with each colposcope delivered or sent to you if required, depending on the
agreement.
2.3 Warranty information
Leisegang Feinmechanik-Optik GmbH can only guarantee the safety, reliability and
performance of Leisegang colposcopes if the user observes the directions in these Instructions
for Use.
The warranty covers the repair or replacement of defective parts insofar as these defects are
based on the manufacture or the material.
The following actions void the warranty with immediate effect:
•Use of the colposcope other than for its intended purpose;
•Improper operation of the colposcope system
•Defects or equipment failures caused by improper operation or normal wear
•Device configurations that are not recommended by Leisegang;
•Modifications or repairs to the colposcope by unauthorized persons;
•Non-compliance with the applicable standards concerning electrical installations.

Marketability
Reporting of seriou
s incidents
11 / 46
2.4 Reporting of serious incidents
PLEASE NOTE: If there is any suspicion that the use of the Leisegang colposcope is or could
be causally related to a serious incident, details of the incident must be provided to
CooperSurgical by telephone on [phone] or via the Email complaint-
[e-mail] and to the local Health Authority in your country.
A ‘serious incident’ means any malfunction or deterioration in the characteristics or
performance of a device made available on the market, including use-error due to
ergonomic features, as well as any inadequacy in the information supplied by the
manufacturer and any undesirable side-effect, that directly or indirectly led, might have
led or might lead to any of the following:
a) the death of a patient, user or other person,
b) the temporary or permanent serious deterioration of a patient's, user's or other
person's state of health,
c) a serious public health threat.

Device description

Essential features
12 / 46
Device description
3.1 Essential features
All Leisegang colposcopes offer the following features:
•Convergent beam path; the beam paths converge at a working distance of 300 mm,
•300 mm working distance,
•Green filter for viewing vessels (apart from angled devices)
•Dioptric correction through adjustable eyepieces,
•LED lighting with an illumination intensity of 45,000-52,000 lx1and a color temperature
between 5,700-6,000 K,
•Leisegang colposcopes are designed for a service life of 10 years.
3.2 Colposcope
Front Rear
1 Magnification changer 8 LED illumination unit
2 Horizontal adjustment 9 Green filter
3 Connector tube 10 Clamp nut for tilt adjustment
(see appendix)
4 Vertical adjustment 11 Lamp cable
5 Thread for mounting plate 12 Eyepieces
6 Front lenses 13 Prism bodies
7 Lamp optics
123,000-35,000 lx for colposcopes with magnification levels 3.75x/7.5x/15x

Device description

Colposcope
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Colposcope type plate
Model number
Device name
CE mark
Serial number
Date of manufacture
Input
Manufacturer Separate disposal of
waste
electrical equipment
Power supply
WARNING Injury through electric shock
The use of a third-party power supply can result in an electric shock.
The colposcope models listed above must only be operated with
the stated power supplies!
1 On/off switch
2 Brightness control
3 Connection for the mains cable
4 Fuse holder
5 Connector socket with bayonet lock for the
lamp cable

Device description

Colposcope
14 / 46
Power supply type plate
Device name
CE mark
Protection class II
Manufacturer
Protection type
Separate disposal of
waste electrical
Model number
Serial number
Date of manufacture
Input
Output
Observe Instructions for
Use

Device description

Stands
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3.3 Stands
Swing-o-matic stand Balance-o-matic stand
1 Star knob screw 1 Circular level
2 Spider base column 2 Column for balance-o-matic stand
3 Clamp flange 3 Spring shaft
4 Supporting ring with latch pin 4 Clamp pair
5 Conical insert 5 Adjusting collar for tension spring
6 5-wheeled spider base with counterweight 6 5-wheeled spider base with
counterweight
7 Frame 7 Conical insert
8 Clamp nut for clamp head 8 Frame
9 Power supply 9 Clamp nut for clamp head
10 Power supply
11 Clamping lever

Device description

Stands
16 / 46
Upright stand
1 Clamp nut for clamp head
2 Power supply
3 Cable outlet
4 Stand column
5 5-wheeled spider base

Technical data

General information
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Technical data
4.1 General information
Operational data
Usage type Not suitable for use in an oxygen-enriched environment
Operating mode Suitable for continuous operation
Applied parts The device has no applied parts that come into direct contact with the
patient
Working distance 300 mm
Environmental and storage conditions
Ambient temperature 10-45 °C
Relative humidity 30-75%, non-condensing
Air pressure 700-1,060 hPa
Storage Dry, cool, protected against dripping water, non-condensing
4.2 Power supply
Power supply B 6400 / LED Y/C
Input 100-240 V ~ 2 Amax, 50/60 Hz
Output
3.2 V 3 Amax
5 V 600 mAmax
Protection against electric shock
Protection class II
Protection against the ingress of solid
foreign bodies and liquids
IP 20
Integrated illumination
With magnification
3.75x/7.5x/15x 7.5x/15x/30x
Light source LED
Power consumption 10 W
Illumination intensity EV
(at a distance of 300 mm)
23,000-35,000 lx 45,000-52,000 lx
Illuminated field diameter 78 mm 58 mm
Field of view diameter 76/38/19 mm 46/23/11.5 mm

Technical data

Standard colposcopes
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4.3 Standard colposcopes
1E LED
Model 1E LED
Mechanical data
Weight 2.75 kg
Dimensions
H x W x D
605 x 135 x 205 mm
Configuration
Magnification 7.5x –
15x 
30x –
Dioptric correction
(±7 diopter) 
Horizontal and
vertical fine adjustment 
Green filter 
45° angled view
–
Head tilt angle 50°

Technical data

Standard colposcopes
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1D LED 1DW LED
Model 1D LED21DW LED
Mechanical data
Weight 3.00 kg 3.10 kg
Dimensions
H x W x D
605 x 135 x 205 mm 640 x 135 x 245 mm
Configuration
Magnification 7.5x 
15x 
30x 
Dioptric correction
(±7 diopter) 
Horizontal and
vertical fine adjustment 
Green filter –
45° angled view – 
Head tilt angle
50°
50°
2Also as 1DS LED (magnification: 3.75x/7.5x/15x)

Technical data

Photo/video colposcopes
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4.4 Photo/video colposcopes
3ML LED 3MLW LED
Model 3ML3LED 3MLW LED
Mechanical data
Weight 3.90 kg 4.05 kg
Dimensions
H x W x D
660 x 135 x 210 mm 675 x 135 x 240 mm
Configuration
Magnification 3.75x – –
7.5x 
15x 
30x 
Dioptric correction
(±7 diopter) 
Horizontal and
vertical fine adjustment 
Green filter –
45° angled view
–

Video camera, integrated – –
Video camera, external 
DSLR camera
(e.g. Canon EOS)

Head tilt angle
45°
45°
3Also as 3MLS LED 1" and 3MLS LED 1/2" (magnification: 3.75x/7.5x/15x)