Related Manuals for Leisegang 1E LED
Summary of Contents for Leisegang 1E LED
- Page 1 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...
- Page 2 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.: +49 30 319 009-0 Fax: +49 30 313 5992 E-Mail: sales.leisegang@coopersurgical.com www.leisegang.de Please read the instructions and information in the Instructions for Use carefully before...
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Page 3: Table Of Contents
C o n t e n t s Contents Purpose ......................5 Intended use ........................5 Indications and field of application..................5 Users and application environment ..................6 Patient population ......................6 Contraindications ....................... 6 Side-effects......................... 6 Clinical benefits ........................6 Performance characteristics .................... - Page 4 C o n t e n t s Operation ......................30 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 ..................
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Page 5: Purpose
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. 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). -
Page 6: Users And Application Environment
There are no known side-effects for the use of Leisegang colposcopes. 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. -
Page 7: General User Information
P u r p o s e General user information 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... -
Page 8: Precautions And Safety Information
• 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. - Page 9 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.
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Page 10: Marketability
Fax: +49 30 313 599-2 E-Mail: sales.leisegang@coopersurgical.com 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... -
Page 11: Reporting Of Serious Incidents
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 +49 30 319009-0 or via the Email complaint- group.leisegang@coopersurgical.com and to the local Health Authority in your country. -
Page 12: Device Description
• • LED lighting with an illumination intensity of 45,000-52,000 lx and a color temperature between 5,700-6,000 K, • Leisegang colposcopes are designed for a service life of 10 years. Colposcope Front Rear Magnification changer LED illumination unit Horizontal adjustment... - Page 13 D e v i c e d e s c r i p t i o n Colposcope Colposcope type plate Device name Model number CE mark Serial number Date of manufacture Input Manufacturer Separate disposal of waste electrical equipment Power supply WARNING Injury through electric shock...
- Page 14 D e v i c e d e s c r i p t i o n Colposcope Power supply type plate Device name Model number CE mark Serial number Date of manufacture Input Output Protection class II Manufacturer Protection type Observe Instructions for Separate disposal of...
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Page 15: Stands
D e v i c e d e s c r i p t i o n Stands Stands Swing-o-matic stand Balance-o-matic stand Star knob screw Circular level Spider base column Column for balance-o-matic stand Clamp flange Spring shaft Supporting ring with latch pin Clamp pair Conical insert... - Page 16 D e v i c e d e s c r i p t i o n Stands Upright stand Clamp nut for clamp head Power supply Cable outlet Stand column 5-wheeled spider base 16 / 46...
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Page 17: Technical Data
T e c h n i c a l d a t a General information Technical data 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... -
Page 18: Standard Colposcopes
T e c h n i c a l d a t a Standard colposcopes Standard colposcopes 1E LED Model 1E LED Mechanical data Weight 2.75 kg Dimensions 605 x 135 x 205 mm H x W x D... - Page 19 T e c h n i c a l d a t a Standard colposcopes 1D LED 1DW LED Model 1DW LED 1D LED Mechanical data Weight 3.00 kg 3.10 kg Dimensions 605 x 135 x 205 mm 640 x 135 x 245 mm H x W x D Configuration Magnification...
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Page 20: Photo/Video Colposcopes
T e c h n i c a l d a t a Photo/video colposcopes Photo/video colposcopes 3ML LED 3MLW LED Model 3MLW LED Mechanical data Weight 3.90 kg 4.05 kg Dimensions 660 x 135 x 210 mm 675 x 135 x 240 mm H x W x D Configuration Magnification... - Page 21 T e c h n i c a l d a t a Photo/video colposcopes 3MVC LED USB 3MVCW LED USB Model 3MVCW LED USB 3MVC LED USB Mechanical data Weight 3.25 kg 3.60 kg Dimensions 625 x 135 x 195 mm 630 x 135 x 245 mm H x W x D Configuration...
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Page 22: Stands
T e c h n i c a l d a t a Stands Stands Stands and spider bases are accessories for colposcopes (see appendix) 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 1.75 kg 5.00 kg... -
Page 23: 5-Wheeled Spider Base
T e c h n i c a l d a t a 5-wheeled spider base 5-wheeled spider base Model Heavy 5-wheeled spider base Weight 25.00 kg (incl. counterweight) Diameter 750 mm Castors Universal castors for all floors, 5 lockable castors 23 / 46... -
Page 24: Model Number
Model number The model number ( ) comprises the following categories: Eyepiece view Magnification Head adjustment Illumination Camera interface Chip size Digit Model name Straight 45° Fine Only tilt Y/C NTSC 1/3ʺ 1/2ʺ 1ʺ tilted ʺ 7.5/15/30x 3.75/7.5/15x Code XXX – Example: 1D-121100 The example shown reflects the model name for a model 1D LED device with the following features:... -
Page 25: Electromagnetic Compatibility
Table 1: Guidance and manufacturer's declaration - electromagnetic radiation Leisegang colposcopes are intended for use in the electromagnetic environment specified below. The user of a Leisegang colposcope must ensure that the device is being operated in such an environment. Emissions test... - Page 26 Table 2: Guidance and manufacturer's declaration - electromagnetic immunity Leisegang colposcopes are intended for use in the electromagnetic environment specified below. The user of a Leisegang colposcope must ensure that the device is being operated in such an environment. Immunity test...
- Page 27 Table 3: Guidance and manufacturer's declaration - electromagnetic immunity Leisegang colposcopes are intended for use in the electromagnetic environment specified below. The user of a Leisegang colposcope must ensure that the device is being operated in such an environment. Immunity test...
- Page 28 Leisegang colposcope - valid for equipment and systems that are not life-sustaining Leisegang colposcopes are for use in an electromagnetic environment in which radiated RF interference is monitored. The customer or user of a Leisegang colposcope can help prevent electromagnetic interference by maintaining a minimum distance between the portable/mobile RF communications device (transmitter) and the Leisegang colposcope as recommended below;...
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Page 29: Transport And Storage
T r a n s p o r t a n d s t o r a g e Storage Transport and storage Storage • If the boxes are stored for a longer period of time, attention needs to be paid that the environmental conditions are dry, cool and non-condensing. -
Page 30: Operation
O p e r a t i o n Preparing the colposcopy Operation Preparing the colposcopy The installation and initial start-up of the colposcope should only be performed by a qualified technician. Please contact your supplier. Before starting the set-up, please check that the power cord is plugged in and that the power supply is turned on. - Page 31 O p e r a t i o n Preparing the colposcopy Balance-o-matic stand Release the locking lever, move the stand frame to the desired height and slide the locking lever back to hold position: In the inactive setting or outside the working position the stand may be in the so-called "park position"...
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Page 32: Performing A Dioptric Correction
O p e r a t i o n Preparing the colposcopy Prerequisite (for balance-o-matic stand): The balance-o-matic stand is in a locked position. 1. Hold the colposcope head firmly and loosen the clamp nut on the clamp head: 2. -
Page 33: Using A Colposcope With Glasses
O p e r a t i o n Preparing the colposcopy 6.1.3 Using a colposcope with glasses 1. Remove the two upper eyepiece cups: 2. Continue as described in section 6.1.4 Adjusting focus of eyepieces. 6.1.4 Adjusting focus of eyepieces 1. -
Page 34: Setting Up Working Distance
O p e r a t i o n Preparing the colposcopy 5. Set the diopter rings of both eyepieces to 0: 6. With your left eye, look through the left eyepiece. The two displayed concentric circles must be in focus. If this is not the case, turn the diopter ring until you can see the two circles sharp and clear. -
Page 35: Using A Colposcope
O p e r a t i o n Using a colposcope Using a colposcope CAUTION Risk of injury in the event of a faulty device A faulty device can cause injuries. If it can be assumed that the device can no longer be operated ... -
Page 36: Swing In The Green Filter
O p e r a t i o n Using a colposcope 6.2.2 Swing in the green filter For a differentiated view of the tissue you can swing in the green filter: Swing in the green filter Swing out green filter Models with a 45°... -
Page 37: Determining The Lesion Size
O p e r a t i o n Using a colposcope 6.2.4 Determining the lesion size There are two concentric rings integrated into the left eyepiece, an inner circle A and an outer circle B. With the help of these rings, the size of the observed object can be estimated. -
Page 38: Care, Maintenance, Inspection
C a r e , m a i n t e n a n c e , i n s p e c t i o n Care and disinfection Care, maintenance, inspection Care and disinfection WARNING Injury through electric shock The power supply is not protected against ingress of water. - Page 39 C a r e , m a i n t e n a n c e , i n s p e c t i o n Care and disinfection Observe the following cleaning and disinfection instructions to avoid damage to the device: A soap solution can be used to clean the lenses.
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Page 40: Maintenance
IEC 62353, should be carried out after each repair and at least every 3 years. Specific functional tests are not defined. Leisegang does not specify the test method to be used to test the electrical safety so that each of the methods shown in the aforementioned standard is permissible for the measurement of protection class II devices. -
Page 41: Customer Service
C u s t o m e r s e r v i c e Customer service In case of technical problems, questions or complaints, please contact your supplier. In case of complaints, always keep the following information at hand: •... -
Page 42: Disposing Of Waste Equipment
D i s p o s i n g o f w a s t e e q u i p m e n t Disposing of waste equipment Countries of the European Union According to the EU Directive on waste electrical and electronic equipment (WEEE) (2012/19/EU), waste electrical and electronic equipment must be disposed of separately. -
Page 43: Glossary
G l o s s a r y Glossary Dioptric correction Compensation of short- or far-sightedness. These can be made individually for each eye using the two eyepieces (range: +7 to -7 diopters). Working distance Distance front lens to object level (= 300 mm). Color temperature T Specifies the color impression of a light source. -
Page 44: Keyword Index
K e y w o r d i n d e x Keyword index Maintenance ........... 40 Adjusting focus of eyepieces ......33 Model number ..........24 Adjusting magnifications ........ 36 Operation ............30 Care ..............38 Clinical benefit ..........6 Complaint ............ - Page 46 Visit our website for more information: Issued by: LEISEGANG Feinmechanik-Optik GmbH Leibnizstrasse 32 D-10625 Berlin Tel.: +49 30 319 009-0 Fax: +49 30 313 5992 E-Mail: sales.leisegang@coopersurgical.com www.leisegang.de Copyright © LEISEGANG Feinmechanik-Optik GmbH 2013-2021 Doc. no.: K0000660 Revision: 4.0 Issue date: 03.2021...
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