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.