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1. any injury to anyone or for any illegal or improper use of the Gynocular that may result from failure to use this product in accordance with the instructions cauti ons warnings or statement of intended use published in this manual A CAUTIONS CAUT dents CAUT CAUT wet o humidi CAUT autho CAUT ON Occasionally inspect the charger s power cord for signs of cuts abrasions or ON The Gynocular may not be used while placed on the charger ON The Gynocular should never be stored or operated in areas where it could get r could be exposed to any environmental conditions like extreme temperature or ity direct sunlight dust etc ON All service to the Gynocular must be performed by Gynius or by an rized repair center ON There are no user serviceable parts in this unit or in its accessories Any attempt 2 to disassemble and or repair this unit will result in voiding of the warranty CAUT ON Potential of mutual interference with other devices and remedies of electromagnetic compatibility If interference is suspected move the device or other equipment further away or turn the device off to test if it is the source of interference If interference is noted physical separation is the best solution CAUTION Do not immerse any part of the unit in cleaning solutions CAUTION Do not touch optical or illumination lenses except as described in the Maintenance section of this
2. eyepiece To locate it unscrew the eyepiece from the main housing The base charger serial number is Located under the base charger Service personnel will give you a Service Notification number Please note this number on the outside of your shipping box Shipping without a Service Notification number will not be accepted for delivery Contact your medical clinic or Gynius sales representative for return or disposal instructions ee Gynius warrants the Gynocular when new to be free of defects in material and workmanship and to perform in accordance with manufacturer s specifications for a period of five years from the date of purchase from Gynius or its authorized distributors or agents Gynius will either repair or replace any components found to be defective or at variance from manufacturer s specifications within this time at no cost to the customer lt shall be the purchaser s responsibility to return the Gynocular to Gynius or an authorized distributor agent or service representative This warranty does not include breakage or failure due to tampering misuse neglect accidents modification or shipping This warranty is also void if the instrument is not used in accordance with manufacturer s recommendations or if repaired by a non authorized agent Purchase date determines warranty requirements No other express warranty is given Gynius or an authorized distributor agent or service representative will provide free recycling of th
3. e Gynocular unit at the end of its lifecycle 1f you have any comments or questions regarding the Gynocular please contact us at info gynocular com Remember to submit the instrument registration warranty card for warranty validation Complete the information and mail the pre addressed card to Gynius Complies with IEC 60601 1 2005 CORR 1 2006 CORR 2 2007 EN 60601 1 2006 CE GYNIUS AB PO Box 55503 10204 Stockholm Sweden
4. extremely bright DO NOT stare directly into illumination lens when ar is turned on ynocular users should adhere to the operating conditions found in this manual Otherwise instrument damage may occur and or operator patient safety may be comprom ised WARNING The charger base is to be a minimum 1 5m from the patient it should not be possible for the user to touch the charger base and the patient at the same time WARNING For safety the Gynocular s AC adapter should only be coupled to a grounded 10 Only charge supply unit WARNING O 0 240 VAC 50 60Hz hospital grade outlet the Gynocular with a Globtek WRIQESOOLCP N MED 12V 0 5A power nly use the supplied battery The battery may only be charged in the unit WARNING Do not expose the battery to heat or mechanical damage Replace the battery after 2 years WARNING WARNING T or if dropped or cracked and dispose in a proper waste facility for electronic parts o modification of this equipment is allowed Do not modify the device he Gynocular should not be used if broken without functioning illumination WARNING Other gynecological vaginal exams are not allowed one day before the colposcopic colposcopic examination Vaginal medication should be avoided two days before the examination A colposcopic examination should not be performed during a menstrual period Gynius assumes n o responsibility for
5. gynocular User Manual _ eee gynius GYNIUS AB PO Box 55503 10204 Stockholm Sweden Copyright 2013 Gynius AB All rights are reserved No one is permitted to reproduce or duplicate in any form this manual or any part thereof without permission from Gynius Gynocular is a registered trademark of Gynius May 2013 CE If you have any questions regarding Gynius products or services please contact us at infoagynocular com Please refer to www gynocular com or email info gynocular com for the phone number of your Local service representative proacin Introduction Congratulations on your purchase of the Gynocular an innovation by Gynius This manual contains the operation and maintenance instructions for your Gynocular Carefully read this document prior to operating the unit Do not allow persons unfamiliar with the instructions to operate the Gynocular Device Description The Gynocular is a hand held colposcope which provides a magnified visualization of the tissues of the cervix vagina vulva and anogential area lt is used to evaluate these tissues and select areas for biopsy without contacting the patient The user is a medical physician or a trained colposcopist The Gynocular is a colposcope with similar specifications to traditional colposcopes The Gynocular has a 300 mm focal distance 3 magnifications 5x 8x and 12x It is a handheld device that comes with a tripod mounting clip
6. humidity Ambient temperature Relative humidity Lamp type Lamp life CE EU USA Technical Data 90 264VAC 47 63Hz 0 18A 120 VAC 0 36A 240VAC Lithium ion 2 4 hours 50mm x 83mm x 166mm Approx 480g 300mm 5x 8x 12x Glass 10C to 40C aximum 80 non condensing 10C to 70C aximum 80 non condensing LED gt 40 000 hours Complies with IEC 60601 1 2005 CORR 1 2006 CORR 2 2007 EN 60601 1 2006 Class Device Class 11 Device LIST OF ACCESSORIES AND PARTS Gynocular Tripod mounting clip Charging base Wall charger Lithium ion battery WUbRwWN LED indicator gynocular GEN On off button CE Red free Light Charging contacts White Light Heat sink Magnification selector Mode selector Eye piece PREPARING DEVICE FOR FIRST USE Inserting and removing the battery 1 Locate the access point on the front of the device 2 Pull the rubber door open at the top and Lift battery Lock 3 Hold the rubber door open while inserting the battery with its contacts on the Left side at the back USING THE DEVICE Switching on and off Ensure that the battery is inserted Ensure that the Gynocular s battery is charged Press the on off button on the back of the device Sie If the illuminator emits light from the front of the unit it is on Note that the unit always starts in 8x magnification and white mode Charging the de
7. ive 1 Gynocular in cradle 2 On or Off as determined by the user s use of the power button 3 Either Illuminator LED Bee ae Cleaning Solutions The solutions listed below are safe for cleaning the housing of the Gynocular if used according to the manufacturer s instructions for cleaning and in accordance with procedures detailed in the cleaning section of this manual soap and warm water solution 70 isopropyl alcohol 10 mild bleach solution 10 Wescodyne Gynocular Cleaning Unplug the power cord from the electrical outlet prior to cleaning the charging base The Gynocular housing can be wiped down with a cloth dampened slightly with a mild solution of soap and warm water making sure to get into the grooves of both the magnification and Light selectors Be careful not to allow the plug prongs of the charging base to get wet Also be careful not to allow the Lenses to get wet Remember to clean the Gynocular after each use to avoid staining the device Lens Cleaning Clean the Lenses and glass covers with isopropyl alcohol or any commercial lens cleaner e Repairs and service must be referred to an authorized Gynius Service Center A technical manual is available upon request for qualified persons Technical Assistance If you have an equipment problem that you cannot resolve check www gynocular com to contact a Gynius Service Centre on normal business days The Gynocular s serial number is Located on the
8. manual Only clean the device as advised in the Maintenance sectio CAUT charge of the unit Presc ription for use CAUT n of this manual ON The device should be placed on the charging station prior to first use to ensure full ION Federal Law restricts this device to sale by or on the order of a licensed healthcare practitioner CAUT CAUT ON Please turn off the Gynocular after each use The image fil means refer to this User Manual ON The Gynocular is cooled by a heat sink which is visible as a silver grey oval with the Gynocular Logo on it This is visible on both sides of the unit To avoid overheating verify that the heat sink is not covered while in use Users should avoid touching the heat sink If the Gynocular feels excessively hot turn it off and w ait for it to cool down before using again 1f problem repeats turn off unit and contact service representative Table of contents 6 Specifications 7 How to use your Gynocular 8 Trouble Shooting 11 How to care for your Gynocular 13 Service 14 Warranty 15 EA eee ltem Power requirements Dimensions Weight Optics Operating environment Storage environment Illumination Regulatory Compliance Class Type Specification Voltage Frequency Current Battery type Battery duration Gynocular Gynocular Focal length agnification Lens material Ambient temperature Relative
9. ndicator Indication Fault and Action WED LED No eo for one Normal condition Orange light flashing 1 second every 3 seconds Battery getting Low Apprx 7 minutes of battery life Left Recharge battery as soon as possible Orange Light flashes 3 times Battery too Low for use switches Recharge battery off after 1 second Orange light on Over heat or circuit error Make sure GynoculLar is off Wait for it to cool down before using again Lf problem repeats turn off unit and contact service representative On but switches Touch sensor error Retry using the Gynocular If Off off after 1 second Orange light on for 500ms problem repeats turn off unit and contact service representative Docked Power Illuminator Indicator Indication Fault and Action WED LED Off No external DC connected to cradle or no contact with the charging connections or error in the controller PCB inside the Gynocular Make sure external DC Off is connected and Gynocular is placed securely in charging station 1f problem repeats turn off unit and contact service representative ae te ng green Charging in progress for Green light on Charging finished Temperature too high for ay lenge Uhtan an 45 C h disconnected or battery fault hnan Internal fault or intermittent Off 9 9 battery connection Contact light service representat
10. that screws into a standard tripod enabling the medical professional to also perform colposcopy with the aid of a stand The Gynocular uses high intensity LEDs for illumination has a green filter and is powered by a rechargeable Lithium ion battery We also provide a charging base for the Gynocular Indications for use colposcopy The Gynocular is intended to provide magnified visualization of the tissues of the vagina cervix and external genitalia lt is used to evaluate these tissues and select areas for biopsy Contra indications colposcopy There are no absolute contraindications to colposcopy 1 Mayeaux E J Jr MD and J Thomas Cox MD Modern Colposcopy Textbook and Atlas American Society for Colposcopy and Cervical Pathology Lippincott Williams amp Wilkins Third edition p 121 A WARNINGS WARNING U sers of this equipment should be thoroughly trained in the appropriate medical procedures Furthermore they should read and understand these instructions before perfo for any othe rming any procedure They should also read and understand the instructions r equipment used in conjunction with the Gynocular failure to do so or misuse of the Gynocular may result in injury to the patient misdiagnosis and or damage to the Gyno cular WARNING Keep all Liquids away from electrical equipment to avoid the possibility of shoc WAR the Gynocul WARNING G and instrument damage G The Lamp is
11. vice Plug the power adapter into the charging base Plug the power adapter into the wall socket Place the device into the charging base front side down The device should be charged prior to first use full battery charge can take up to 2 5 hrs The device is charging when the LED indicator is blinking The full charge has been reached when the LED indicator is a steady green light Selecting a magnification setting With the unit on swipe your index finger gently and slowly across the mode selector Swiping right to left will increase the magnification Swiping Left to right will decrease the magnification Selecting a light mode Attaching the tripod holder Locate the tripod screw insert under the tripod mounting clip With the unit on swipe your index Screw your tripod s screw thread into finger gently and slowly across the this insert mode selector Slide the Gynocular into the tripod Swiping right to left will switch mounting clip until it is in the middle between white mode and red free of the holder mode Swiping Left to right will increase and decrease light intensity alternately in white mode Note that selecting red free mode always resets the magnification to 12x Note that if you change from red free mode to white mode the magnification will remain the same E testes The following table can be used to understand what faults may be present with the Gynocular Docked Power Illuminator I

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