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"
3MVS LED Y/C NTSC
Instructions for Use
English

Publication details
Copyright ©LEISEGANG Feinmechanik-Optik GmbH 2013-2019.
All rights, delivery availability and technical changes reserved.
Issued by:
LEISEGANG Feinmechanik-Optik GmbH
Leibnizstrasse 32
D-10625 Berlin
Phone: [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
3 / 44
Contents
Purpose ...................................................................................................... 51
1.1 Intended use.............................................................................................................. 5
1.2 Indications and field of application......................................................................... 5
1.3 Users and application environment........................................................................ 6
1.4 Contraindications ..................................................................................................... 6
1.5 Adverse effects ......................................................................................................... 6
1.6 General user information ......................................................................................... 6
1.7 Safety instructions.................................................................................................... 7
1.7.1 Meaning of symbols in these instructions....................................................... 7
1.7.2 Meaning of symbols on the device and outer packaging ............................... 7
1.7.3 Precautions and safety information ................................................................ 8
Marketability............................................................................................... 92
2.1 Medical device and market placement ................................................................... 9
2.2 Warranty information................................................................................................ 9
Device description................................................................................... 103
3.1 Essential features ................................................................................................... 10
3.2 Colposcope ............................................................................................................. 10
3.3 Stands ...................................................................................................................... 13
Technical data.......................................................................................... 154
4.1 General information................................................................................................ 15
4.2 Power supply........................................................................................................... 15
4.3 Standard colposcopes ........................................................................................... 16
4.4 Photo/video colposcopes ...................................................................................... 18
4.5 Stands ...................................................................................................................... 20
4.6 5-wheeled spider base............................................................................................ 21
4.7 Model number ......................................................................................................... 22
4.8 Electromagnetic compatibility............................................................................... 23
Transport and storage............................................................................. 275
5.1 Storage..................................................................................................................... 27
5.2 Disposal of packaging material............................................................................. 27
Operation.................................................................................................. 286
6.1 Preparing the colposcopy...................................................................................... 28
6.1.1 Performing height adjustments..................................................................... 28

Contents
4 / 44
6.1.2 Performing a dioptric correction.................................................................... 30
6.1.3 Using a colposcope with glasses ................................................................. 31
6.1.4 Adjusting focus of eyepieces ........................................................................ 31
6.1.5 Setting up working distance.......................................................................... 32
6.2 Using a colposcope ................................................................................................ 33
6.2.1 Performing fine adjustments......................................................................... 33
6.2.2 Swing in the green filter ................................................................................ 34
6.2.3 Adjusting magnifications............................................................................... 34
6.2.4 Determining the lesion size .......................................................................... 35
Care, maintenance, inspection............................................................... 367
7.1 Care and disinfection ............................................................................................. 36
7.2 Maintenance ............................................................................................................ 37
7.3 Inspection, repeat tests.......................................................................................... 38
Repair ....................................................................................................... 388
Customer service .................................................................................... 399
Disposing of waste equipment............................................................... 4010
Glossary ................................................................................................... 4111
Bibliography............................................................................................. 4212
Keyword index ......................................................................................... 4313

Purpose

Intended use
5 / 44
Purpose1
1.1 Intended use
Leisegang colposcopes are used in gynaecological examinations for magnified, non-
contacting viewing of the external female genitalia (vulva, vagina, portio). The colpo-
scopes may also serve for magnified, contactless viewing of other external organs.
Leisegang photo/video colposcopes with integrated or externally connected camera
can also be used to document the finding.
1.2 Indications and field of application
Leisegang colposcopes are used in gynaecological examinations for magnified, non-
contacting viewing of the external female genitalia (vulva, vagina, portio).
The device is intended for use in medical practices and/or clinics. The device is not
intended for use at locations with MRI, CT, diathermy, RFID and electromagnetic se-
curity systems, such as metal detectors.
The colposcope is intended for multiple uses. Chapter 7.1 Care and disinfection de-
scribes information about cleaning and disinfection.

Purpose

Users and application environment
6 / 44
1.3 Users and application environment
Users
User group Qualification Activity
End user:
Medical practitioners
(physicians)
Gynaecologist 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 Contraindications
There are no known contraindications to the use of Leisegang colposcopes.
1.5 Adverse effects
There are no known adverse effects for the use of Leisegang colposcopes.
1.6 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)

Purpose

Safety instructions
7 / 44
1.7 Safety instructions
1.7.1 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.
1.7.2 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
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 Colpo-
scope
Generic device name in
accordance with Global Medical
Device Nomenclature (GMDN)
Alternating current Direct current
Protection class II

Purpose

Safety instructions
8 / 44
1.7.3 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 connector 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.
•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, authorised
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

Medical device and market placement
9 / 44
Marketability2
2.1 Medical device and market placement
According to Annex IX of the 93/42/EEC Medical Devices Directive, Leisegang
colposcopes are class I medical devices.
In a conformity assessment procedure in accordance with Annex VII of the Medical
Device Directive, Leisegang Feinmechanik-Optik GmbH demonstrated that the
Leisegang colposcopes fulfil the essential requirements of Annex I of the directive.
The devices bear the CE mark to indicate compliance with these requirements. A
copy of the Declaration of the Conformity is included with each colposcope delivered
for the first time.
2.2 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 unauthorised persons;
•Non-compliance with the applicable standards concerning electrical installations.

Device description

Essential features
10 / 44
Device description3
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 colour
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
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
11 / 44
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
12 / 44
Power supply type plate
Device name
CE mark
Protection class II
Manufacturer
Protection type
Separate
disposal
of
waste electrical
equipment
Model number
Serial number
Date of manufacture
Input
Output
Observe Instructions
for Use

Device description

Stands
13 / 44
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
14 / 44
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
15 / 44
Technical data4
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
Colour temperature T F 5,700-6,000 K
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
16 / 44
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 dioptre) 
Horizontal and vertical fi-
ne adjustment 
Green filter 
45° angled view
–
Head tilt angle
50°

Technical data

Standard colposcopes
17 / 44
1D LED 1DW LED
Model 1D LED
2
1DW 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 dioptre) 
Horizontal and vertical fi-
ne 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
18 / 44
4.4 Photo/video colposcopes
3ML LED 3MVS LED Y/C NTSC
Model 3ML LED33MLW LED 3MVS LED Y/C NTSC
Mechanical data
Weight 3.90 kg 4.05 kg 3.50 kg
Dimensions H x W x D 660 x 135 x 210 mm 675 x 135 x 240 mm 605 x 135 x 205 mm
Configuration
Magnification 3.75x – – 
7.5x 
15x 
30x –
Dioptric correction
(±7 dioptre) 
Horizontal and vertical fi-
ne adjustment 
Green filter – 
45° angled view
–

–
Video camera, integrated
–
–

Video camera, external –
DSLR camera
(e.g. Canon EOS)
–
Head tilt angle
45°
45°
50°
3Also as 3MLS LED 1" and 3MLS LED 1/2" (magnification: 3.75x/7.5x/15x)

Technical data
Photo/video colposco
pes
19 / 44
3MVC LED USB 3MVCW LED USB
Model 3MVC LED USB
4
3MVCW LED USB
Mechanical data
Weight 3.25 kg 3.60 kg
Dimensions H x W x D 625 x 135 x 195 mm 630 x 135 x 245 mm
Configuration
Magnification 7.5x 
15x 
30x 
Dioptic correction
(±7 dioptre) 
Horizontal and vertical
fine adjustment 
Green filter –
45° angled view
–

Video camera, integrat-
ed 
Video camera, external
–
–
DSLR camera
(Canon EOS) – –
Head tilt angle 50° 50°
4Also as 3MVCS LED USB (magnification: 3.75x/7.5x/15x)

Technical data

Stands
20 / 44
4.5 Stands
Stands and spider bases are accessories for the colposcope.
Upright stand Swing-o-matic stand Balance-o-matic stand
Model Upright stand Swing-o-matic stand Balance-o-matic
stand
Mechanical data
Weight (without spider
base)
1.75 kg 5.00 kg 7.90 kg
Weight (with spider
base)
26.75 kg 30.00 kg 32.90 kg
Dimensions H x W max 670 x 120 mm 680 x 640 mm 750 x 715 mm
Horizontal movement –
(rigid column)
freely rotating in a
radius of 600 mm
swinging freely in a
radius of 600 mm
Vertical movement –
(manually lockable)
–
(manually lockable)
balanced zero-force-
movement, lockable
Working height 970-1090 mm
(manually lockable)
860-1260 mm
(manually lockable)
850-1410 mm
(two-stage locking
mechanism)
Configuration
Chair mounting
(right/left) – 
Assembly of the 5-
wheeled spider base
only with lightweight
5 wheeled spider base
(without
counterweight)
