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" 3MVS LED Y/C NTSC Instructions for Use English...
- Page 2 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: +49 30 319 009-0 Fax: +49 30 313 5992 E-Mail: info@leisegang.de www.leisegang.de Please read the instructions and information in the Instructions for Use carefully...
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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 Contraindications ..................... 6 Adverse effects ......................6 General user information ..................6 Safety instructions .................... - Page 4 C o n t e n t s 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 Using a colposcope ....................33 6.2.1 Performing fine adjustments .................
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Page 5: Purpose
Purpose 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. -
Page 6: Users And Application Environment
Maintenance of the device Medical personnel Application environment Leisegang colposcopes are only intended for use in rooms used for medical purposes. Observe the local requirements for the electrical installation. Contraindications There are no known contraindications to the use of Leisegang colposcopes. -
Page 7: Safety Instructions
P u r p o s e Safety instructions 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. -
Page 8: Precautions And Safety Information
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. -
Page 9: Marketability
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. -
Page 10: Device Description
Dioptric correction through adjustable eyepieces, • LED lighting with an illumination intensity of 45,000-52,000 lx and a colour 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... - Page 11 D e v i c e d e s c r i p t i o n Colposcope 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...
- Page 12 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 Separate disposal...
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Page 13: 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 14: Clamp Nut For Clamp Head
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 14 / 44... -
Page 15: 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 16: 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 H x W x D 605 x 135 x 205 mm... - Page 17 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 H x W x D 605 x 135 x 205 mm 640 x 135 x 245 mm Configuration Magnification...
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Page 18: Photo/Video Colposcopes
T e c h n i c a l d a t a Photo/video colposcopes Photo/video colposcopes 3ML LED 3MVS LED Y/C NTSC Model 3MLW LED 3MVS LED Y/C NTSC 3ML LED Mechanical data Weight 3.90 kg 4.05 kg 3.50 kg Dimensions H x W x D 660 x 135 x 210 mm... - Page 19 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 H x W x D 625 x 135 x 195 mm 630 x 135 x 245 mm Configuration...
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Page 20: Stands
T e c h n i c a l d a t a Stands 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 1.75 kg 5.00 kg... -
Page 21: 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 650 mm Castors Universal castors for all floors, 5 lockable castors 21 / 44... -
Page 22: 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° tilted Fine Only tilt USB Y/C NTSC -- 1/4ʺ 1/3ʺ 1/2ʺ 1ʺ 7.5/15/30x 3.75/7.5/15x Code XXX –... -
Page 23: 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 24 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 25 RF compliance level, particular at- tention must be paid in order to guarantee a normal operation of the Leisegang colpo- scope. If an incorrect operation is observed, additional measures may be required, such as the realignment or relocation of the Leisegang colposcope.
- Page 26 Leisegang colposcopes are for use in an electromagnetic environment in which radi- ated 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 Leise- gang colposcope as recommended below;...
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Page 27: 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 28: 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 29 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 a non-active position or if outside the working position, the stand may be in what is referred to as the "park position"...
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Page 30: 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 clamping nut on the clamp head: 2. -
Page 31: 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 32: 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 33: 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 ... -
Page 34: 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 35: 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 eye- piece, 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 36: 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 37: Maintenance
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 38: Inspection, Repeat Tests
R e p a i r Inspection, repeat tests Leisegang Feinmechanik-Optik GmbH recommends a regular inspection of the de- vice every 3 years. Please contact your supplier for further information. Repair • Repairs may only be carried out by authorised persons or organisations. In the event of a necessary repair, please contact your supplier. -
Page 39: 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 40: 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) (2002/96/EC), waste electrical and electronic equipment must be dis- posed of separately. -
Page 41: Glossary
G l o s s a r y Glossary Dioptric correction Compensation of short- or far-sightedness. This can be done for each eye individually by means of the two eyepieces (range: +7 to -7 diopters). Working distance Distance front lens to object level (= 300 mm). Colour temperature T Specifies the colour impression of a light source. -
Page 42: Bibliography
, J. L.: Biographic sketch: Powell's Pearls: Hans Peter Hinselmann, MD OWELL (1884-1959). In: Obstetrical & gynecological survey No. 59(10) (2004), pp. 693-695 H. H : Das Leisegang Kolposkop. In: Medizinische Technik No. 73 EINECKE ERLAG (1953), pp. 3-4 , L. E.; M , A. -
Page 43: Keyword Index
K e y w o r d i n d e x Keyword index Adjusting focus of eyepieces ....31 Inspection ..........38 Adjusting magnifications ......34 Maintenance ..........37 Bibliography ..........42 Model number .......... 22 Care ............36 Operation .......... - Page 44 Visit our website for more information: Issued by: LEISEGANG Feinmechanik-Optik GmbH Leibnizstrasse 32 D-10625 Berlin Phone: +49 30 319 009-0 Fax: +49 30 313 5992 E-mail: info@leisegang.de www.leisegang.de Copyright © LEISEGANG Feinmechanik-Optik GmbH 2013-2019 Doc. no.: K0000660 Revision: 3.0 Issue date: 07.2019...
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