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Summary of Contents for Cooper Surgical Leisegang OptiK 1
- Page 1 Leisegang Colposcopes and Accessories Instructions for Use English All rights reserved. No part of this work may be reproduced in any form without written permission from CooperSurgical, Inc. OPTIKCOLPO-IFU • Rev.C • 07/22...
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Page 2: Table Of Contents
Table of Contents Table of Contents 1 Important General References Appropriate Use 1.1.1 Indications for Use 1.1.2 Contraindications Symbols How to read these Operating Instructions 2 Important Notes on Safety List of Warnings 3 Certifications CE Certification UL Certification 4 Short Product Overview 5 Guarantee 6 Colposcopes Equipment Overview, Installation and Operation... - Page 3 Table of Contents Accessories Video Adapters 9.1.1 Mounting Video Adapters Camera 10 Care and Maintenance 10.1 Disinfection 11 Replacement Wear Parts and Technical Service 11.1 Technical Service 11.2 Spare and Worn Parts 11.2.1 Lamp Change 11.2.2 Fuses 12 Technical Data and Notes on Safety 12.1 EMC - Electromagnetic Compatibility 12.2 Control and Maintenance 12.3 Returns, Complaints...
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Page 4: Important General References
1.1.2 Contraindications The Cooper Surgical Leisegang Colposcope is a device for viewing the body from a distance and is not intended for patient contact. Because of this there are no contraindications for use of a Colposcope. -
Page 5: Symbols
Important General References Symbols Symbol Meaning Symbol Meaning Consult accompanying documents / Manufacturers address Instructions for use Protection Class II Date of Manufacture IP20 Ingress protection rating Type B applied part Symbol indicates that the device should be sent to the special agencies Serial number of the product according to local regulations for separate collection after its useful life... -
Page 6: Important Notes On Safety
Important Notes on Safety Important Notes on Safety Please read this chapter first! Before you begin using the colposcope, please become familiar with the following safety regulations and keep these in mind while using the device. List of Warnings 1. Light Emitting Diode (LED) colposcopes are Safety Class II products and DO NOT require grounded power cords or outlets. -
Page 7: Certifications
Important Notes on Safety Objective Determination Colposcopes are utilized for the magnified, illuminated gynecological examination of the female genital organs (vulva, vagina and cervix). With certain model colposcopes, you can attach cameras or digital image management systems for subsequent evaluation and documentation. Colposcopes are used exclusively for diagnostic purposes and thus correspond to §3, Para. -
Page 8: Short Product Overview
Short Product Overview Short Product Overview Specific terms and technical solutions related to Leisegang colposcopes are explained below. For older Leisegang colposcopes, you may need to reference other manuals. • Optimal treatment success depends directly on optimum examination results. It is vital that the colposcope supplies a three dimensional image, which represents, as best as possible, the topography and blood vessels of the examination subject. - Page 9 Short Product Overview • A par focal lens is an objective that stays approximately in focus when the magnification is changed. For example, if a colposcope is switched from a low power (3.75x) to a high power (7.5x), the object stays in focus.
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Page 10: Guarantee
Guarantee Guarantee CHANGES IN SPECIFICATIONS FOR PRODUCT. All specifications for the Product are subject to change without notice. COOPERSURGICAL INC., TRUMBULL, CT 06611 USA. Contents of this Instruction for Use and other written materials provided to Licensee with the Product may not be reproduced by any means whatsoever without prior written permission from CooperSurgical, Inc. -
Page 11: Colposcopes
Colposcopes Colposcopes Equipment Overview, Installation and Operation Before actual use and installation of your device, check the outside of the transport packaging, the devices or subassemblies supplied for damage. The following chapters give step by step instructions for the testing, installation, operation and security references. -
Page 12: Standard Colposcopes
Colposcopes Standard Colposcopes OptiK™ Model 1 (1DL-LED) OptiK Model 1 series includes Leisegang popular standard colposcopes with precision fine adjustments in horizontal and vertical direction, green filter, high performance optics and LED lighting: OptiK Model 1 Features • 3-step magnification drum changer (3.75x/7.5x/15x) •... -
Page 13: Optik™ Model 2 (3Mtl Led, 3Mvcl Led Usb)
Colposcopes OptiK™ Model 2 (3MTL-LED, 3MVCL-LED-USB) The Colposcopes of OptiK Model 2 series are Leisegang’s popular Digital/Photo colposcopes with precision fine adjustments in horizontal and vertical direction, high performance optics and LED lighting. The plate identifications for OptiK Model 2 vary according to the camera configuration purchased. OptiK Model 2 Features... -
Page 14: Camera Adapter
Colposcopes 6.4.1 Camera Adapter You can connect a digital SLR camera to the port of OptiK Model 2 (3MTL-LED 1.0” only). You will need a special tubus/bayonet depending on the camera. The kind of tubus can be a T2 adapter, video adapter or C-mount camera adapter in several sizes. -
Page 15: General Adjustments
Colposcopes General Adjustments Most adjustments are the same for all Leisegang colposcopes. Normal adjustments mean the daily use adjustments such as adjusting height, focusing, choosing the magnification, or turning on the green filter. 6.5.1 Rough Height Adjustment Every colposcope head is packed into a solid plastic bag on delivery, to protect against dust and dirt. The head always represents the last assembled part. -
Page 16: Vertical And Horizontal Fine Adjustment
Colposcopes 6.5.2 Vertical and Horizontal Fine Adjustment The most used adjustments are the horizontal and vertical adjustments of the colposcope head. Use the vertical adjustment for your posture/height and the horizontal adjustment for focusing the object. 1 Vertical drive Moves the colposcope head up and down (max. 80 mm). 2 Horizontal drive- Focus Moves the colposcope head back and forth (max. -
Page 17: Focusing The Leisegang Colposcope
Colposcopes 6.5.5 Focusing the Leisegang Colposcope The working distance of a properly focused Leisegang colposcope is about 300 mm or 11.8 inches. A sheet of paper, at 11 inches, is a good starting reference for length between the colposcope and the object of focus. -
Page 18: Do-It-Yourself Troubleshooting
Colposcopes Do-It-Yourself Troubleshooting All Leisegang Colposcopes and accessories are adjusted prior to shipping. Over the years, daily usage may require you to make special adjustments to the colposcope, such as rough height hold adjustment, etc. This chapter provides an introduction to Do-It-Yourself Troubleshooting. 6.6.1 Fine Height Adjustment Over the years, your scope head’s fine adjustment may need to be tightened in order to hold position. -
Page 19: Hold Adjustment For Fine Focus
Colposcopes 6.6.2 Hold Adjustment for Fine Focus If the colposcope will not hold the fine focus adjustment position, slightly tighten the knob below the magnification dial: 6.6.3 Fuses Fuse holder is located at the power supply socket of illumination unit. The fuse is located in a fuse holder. After switching off the device and unplugging the power supply from the device, the fuse holder can be pulled out from the casing with a screwdriver. -
Page 20: Stands
Stands Stands All Leisegang stands (base or mount) are characterized by the highest levels of quality and stability for daily use in practices and clinics. The decision on the type of stand should be made prior to ordering, since the respective stands differ. NOTE: Stands and spider bases are accessories for the colposcopes and are available at CooperSurgical: •... -
Page 21: Swing Stand Assembly
Stands Dimensions 600 mm 300 mm min. 860 mm max. 1260 mm 800 mm 750 mm 7.1.1 Swing Stand Assembly See section 7.2.1 Balance-o-Matic Stand Assembly. The assembly for both stands is nearly the same. The next step is assembling the illumination unit (see chapter 8 Illumination Units). The Balance-o-Matic Stand The Leisegang Balance-o-Matic Stand offers a maximum of comfort with the greatest ease of operability. -
Page 22: Balance-O-Matic Stand Assembly
Stands Dimensions 600 mm 300 mm min. 850 mm max. 1410 mm 860 mm 750 mm 7.2.1 Balance-o-Matic Stand Assembly 1. Loosen the cross connection (4) and remove with the supplied Allen key. 2. The clamp (3) is displaced upwards with the slit casing over the protection pin (5) and the cross connection is secured again. -
Page 23: Tilt Stand And Upright Stand (Roller Base)
Stands 3. For the purposes of weight compensation, an extension spring is located in the external stand tube, whose loading must be adapted to the weight of the colposcope head, as well as to additional subassemblies, by means of a control ring (8). CAUTION Risk of crushing through weight When adjusting the tension of the spring, be careful that the Allen key does not... - Page 24 Stands Tilt Stand The ball joint (1) is screwed securely to the base plate, using the 4 hexagon socket screws. A suitable Allen key is included in the scope of delivery. The red bolt at the bottom of the base plate (2) adjusts the clamping force of the ball joint and determines the force that is necessary to tilt the stand.
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Page 25: Installations
Stands Upright Stand In the case of the Upright Stand with light 5-wheel roller base, the same upright stand is used as with the Tilt stand; however, the difference is that the base plate has been replaced by a light rolling base. Unlike the Tilt, this Upright Stand is not equipped with a tilting link, so that the rough adjustment must be implemented through the movement of the entire system. -
Page 26: The Balance-O-Matic Stand On Mobile 5-Wheel Roller Base
Stands 3. The stand has been preset in the factory to a predetermined height. In order to change this, slightly pull out the small locking pin (7) at the supporting ring of the lower stand frame and adjust as needed to one of the existing boreholes. -
Page 27: Power Supply
Illumination Units Power Supply Power Supply for LED-illumination. Note that the box provides an insulated ground versus a wired ground. The Power Supply can be mounted on the Swing or Balance-o-Matic Stand between the two tubes of the upper frame. For Upright Stands you have to use two clamps: WARNING Injury due to electrical shock... -
Page 28: Led-Lighting
Illumination Units LED-Lighting LED Unit LED stands for Light Emitting Diode, this light is produced in an electronic process in semiconductor without substantial heat losses. LED Colposcopes are equipped with an LED unit. This consists of a heat sink unit with LED and the condenser lens optics. -
Page 29: Accessories
Accessories Accessories CooperSurgical offers several kinds of accessories: • Video Adapter • Cameras • Image Management Software • Bases The following sections provide more information on the above bold items. Video Adapters All Leisegang colposcopes accept the Leisegang video adapter via a mounting plate which can be mounted with 3 screws at the front of the scope. -
Page 30: Camera
Accessories 3. Push both pins of video adapter and fasten area into mounting base plate and tighten the screw knob clockwise: ► Video adapter is ready to use. Cameras CooperSurgical offers the following camera: Canon EOS Rebel dSLR The Canon EOS Digital Rebel (dSLR) is designed for use with the OptiK Model 2 with 1.0” CCD (3MTL LED 1.0”), using a special bayonet. -
Page 31: Care And Maintenance
Care and Maintenance Care and Maintenance Colposcope care and maintenance is simple - no great effort is needed to keep your device in a tidy and functional condition. It is recommended that the colposcope be handled with gloves. We also recommend that you consistently carry out the measures described below, in order to ensure long term and trouble free functioning. - Page 32 Care and Maintenance Lenses CAUTION Damage to the device To avoid damage to the equipment, observe the following cleaning instructions: ► You can use a watery soap solution for cleaning the lenses. Use special lens cloths to wipe the lens dry. ►...
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Page 33: Replacement Wear Parts And Technical Service
Replacement Wear Parts and Technical Service Replacement Wear Parts and Technical Service 11.1 Technical Service When contacting CooperSurgical’s Service and Repair department for servicing Leisegang colposcopes, you will need the following information: Details on the defect that has occurred and corresponding serial numbers of the individual components. -
Page 34: Technical Data And Notes On Safety
• Occasionally check that the locking weight under the roller base has not loosened. If so, tightened screws. • Ensure that mechanical adjustments are working smoothly and correctly. In case of occurrence of problems, contact Cooper Surgical Service and Repair Department • Regularly check the steel pulling cable for wear. 12.3 Returns, Complaints Returns of devices or subassemblies requires prior arrangement with CooperSurgical through a Service and Repair Authorization form. -
Page 35: Technical Data
Technical Data Technical Data 13.1 Type Plates Except for stands, all Leisegang devices carry type plates. The contents of type plates show the product name and the serial number. Electrical devices show the power data and additional information such as year of construction and CE and/ or UL mark. -
Page 36: Type Plate Power Supply
Technical Data 13.1.2 Type Plate Power Supply Type plate of power supply unit Device name Model number CE-mark Serial number Date of Manufacturer Input Output Protection class II Manufacturer UL-mark Type of protection Note‚ Consult Separate disposal of waste electrical devices Instructions for use This plate is located on the front side of the powers supply. -
Page 37: General
Technical Data Technical data General 13.4 Operational data Mode of use 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 Devices with magnification 3.75x/ 7.5x/15x... -
Page 38: Environment Conditions
Technical Data Environment Conditions 13.6 Environment and storage conditions Environment temperature 10-45 °C 30-75 %, non-condensing Relative humidity 700-1.060 hPa Air pressure Dry, cool, protected from dripping water, Storage protected from condensation Dimensions and Weights 13.7 (all Information approx.) Device Weight Standard colposcope head 3.5 kg... -
Page 39: Electrical Connections
Technical Data Electrical Connections 13.8 LED Colposcopes Rated voltage: Please note information on label 100 - 240V~ 50/60 Hz Nominal frequency: Please note information on label 45 Watts Wattage Power Consumption 13.9 LED Colposcopes Power Supply 18W LED (LED Colposcopes only) 24 VA Lamps 13.10... -
Page 40: Electromagnetic Compatibility
Technical Data Electromagnetic compatibility 13.13 Leisegang colposcopes are intended for use in an environment, that meets the below mentioned electromagnetic specifications. Leisegang colposcopes have been designed to withstand the effects of EMI (electromagnetic interference) and meet the most current EMC standards. However, extremely high levels of electromagnetic energy (above the levels mentioned in IEC 60601-1-2) may still cause interference. -
Page 41: Immunity
Technical Data 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. -
Page 42: Immunity
Technical Data 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. - Page 43 Technical Data Table 4: Recommended separation distance between portable/mobile RF communications device and a Leisegang colposcope - valid for equipment and systems not intended for life-sustaining applications Leisegang colposcopes are for use in an electromagnetic environment in which radiated RF disturbances are monitored.
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Page 44: Model Number
Model number 13.14 The model number ( ) consists of the following categories: Ocular view Magnification Head calibration Lighting Camera interface Chip size Number Model name Straight 45° Fine Tilting only -- USB Y/C NTSC -- 1/4ʺ 1/3ʺ 1/2ʺ 1ʺ 15x 7.5/15/30x 3.75/7.5/15x tilted Code...
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