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Summary of Contents for Welch Allyn KleenSpec 790 Series
- Page 1 KleenSpec ® 790 Series Cordless Illumination System for the 590 Series Vaginal Speculum 79910 Directions for Use...
- Page 2 Caution: Federal US law restricts sale of the device identified in this manual to, or on the order of, a licensed physician. Welch Allyn assumes no responsibility for any injury, or for any illegal or improper use of the product, that may result from failure to use this product in accordance with the instructions, cautions, warnings, or indications for use published in this manual.
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Page 3: Table Of Contents
Contents Introduction ......1 Intended use ....... . . 1 Contraindications . -
Page 5: Introduction
Directions for use Cordless illumination system Introduction ® The Welch Allyn KleenSpec 790 series cordless illumination system can be used with or without the KleenSpec 590 series disposable vaginal speculum. The cordless illumination system consists of the following items. Cordless... -
Page 6: User Profile
Welch Allyn User profile The intended users of the illuminator are medical professionals who are qualified to perform a pelvic examination. Symbols The symbols illustrated on the following pages may appear in this manual or on the illuminator, charging station, auxiliary power cord, packaging, or shipping container. - Page 7 Table 3. Certification symbols Meets essential requirements of European Medical Device Directive 93/42/EEC. European Regulatory Manager EC REP Welch Allyn LTD. Navan Business Park, Dublin Road Navan, County Meath, Republic of Ireland Tel.: +353 46 90 67700 Fax: +353 46 90 67755 Complies with applicable U.S.
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Page 8: Using The System Safely
Welch Allyn Using the system safely Before using the cordless illumination system, you must read and understand the following safety-related information. General warnings The following warning statements apply to use of the cordless illumination system in general. Warning statements that apply specifically to particular procedures, such as cleaning, appear in the corresponding sections of the manual. - Page 9 Caution Cordless illuminator, charging station, and auxiliary power cord are not protected from the ingress of liquid. Caution There are no user-serviceable parts inside the device. In case of a malfunction, call Welch Allyn and precisely describe the problem. Caution This device complies with current required...
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Page 10: Utilisation Sécuritaire Du Système
Welch Allyn Utilisation sécuritaire du système Avant d'utiliser le système d’éclairage sans fil, vous devez bien lire et comprendre les renseignements de sécurité suivants. Avertissements généraux Les avertissements suivants s’appliquent à l'utilisation du système d’éclairage sans fil en général. Les avertissements qui s'appliquent à des procédures particulières, comme le nettoyage, sont abordés dans les... - Page 11 être munis des mêmes connecteurs d'alimentation. Si vous n'avez plus le bloc d'alimentation et/ou le cordon d'alimentation originaux, veuillez communiquer avec Welch Allyn pour obtenir des pièces de remplacement. Mises en garde générales Les mises ne garde suivantes s’appliquent à...
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Page 12: Charging The Illuminator
Welch Allyn Charging the illuminator Charge the illuminator before using it the first time, or whenever its low-charge indicator turns on. Power switch Low-charge indicator: On = battery low To charge the illuminator If LED is lit, turn power switch off. -
Page 13: Using The Illuminator For A Pelvic Exam
Directions for use Cordless illumination system Using the illuminator for a pelvic exam Fully insert the illuminator into a 590 series speculum (a). The LED automatically turns on. 2. Conduct the examination. 3. If the LED turns off, do not remove the speculum. -
Page 14: Maintenance
Welch Allyn Maintenance Cleaning and disinfecting ® Use CaviWipe wipes for both cleaning and disinfecting.* *EPA-approved intermediate-level disinfectant appropriately labeled as effective against TB mycobacterium tuberculosis (per AAMI TIR-12, 2004, section 5.2.3) Caution Use only the cleaning and disinfection methods described in this manual. -
Page 15: Inspecting The System
Electrical Equipment (WEEE). If this product is contaminated, this directive does not apply. For more specific disposal information, see www.welchallyn.com/weee, or contact Welch Allyn. Outside the EU When the product reaches its end of life, recycle the components according to national, state, and local regulations, or return the... -
Page 16: Troubleshooting
Illuminator is not seated properly in charging base. Reinsert the illuminator into the charging base, and verify that the status indicator glows amber. Contacts For information about any Welch Allyn product, call the nearest Welch Allyn representative: 1 800 535 6663 Australia... -
Page 17: Appendix
Directions for use Cordless illumination system Appendix Specifications Item Specification Auxiliary power cord transformer U.S. & Canada International Classification Class I, type BF applied part Class II, type BF applied part Input 120 V ~ 60 Hz 90–264 VAC ~ 50–60 Hz, 200 mA Output 5 VDC, 300 mA 5 VDC, 300 mA... - Page 18 Welch Allyn Item (continued) Specification (continued) Shipping and storage conditions Temperature -20° C to +49° C (-4° F to +120° F) Relative humidity 15% to 95% noncondensing Altitude 500 hPa to 1060 hPa Intermittent operation ≤ 10 minutes on, ≥ 5 minutes off between uses Illuminator with speculum ≤...
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Page 19: Part Numbers
Directions for use Cordless illumination system Part numbers Item Order Number Cordless illuminator system U.S. & Canada: 79910 with charging station International: 79915* Cordless illuminator system U.S. & Canada: 79920 with charging station and International: 79925* auxiliary power cord Cordless illuminator U.S. -
Page 20: Limited Warranty
Product or accessory free of charge. If your Product requires repairs covered by this warranty, upon your request Welch Allyn will loan to you, at no cost, a substitute Product for use until your repaired Product is returned. -
Page 21: Service Policy
Cordless illumination system Service policy All repairs on products under warranty must be performed or approved by Welch Allyn. Unauthorized repairs will void the warranty. In addition, whether or not covered under warranty, any product repair shall exclusively be performed by Welch Allyn certified service personnel. -
Page 22: Emc Guidance And Manufacturer's Declarations
Welch Allyn EMC guidance and manufacturer’s declarations Table 1. Emissions for all EQUIPMENT and SYSTEMS The 790 series cordless illumination system is intended for use in the electromagnetic environment specified below. The customer or user of the 790 series cordless illumination system should assure that it is used in such an environment. - Page 23 Directions for use Cordless illumination system Table 2. Immunity for all EQUIPMENT and SYSTEMS The 790 series cordless illumination system is intended for use in the electromagnetic environment specified below. The customer or user of the 790 series cordless illumination system should assure that it is used in such an environment.
- Page 24 Welch Allyn Table 3. Electromagnetic immunity The 790 series cordless illumination system is intended for use in the electromagnetic environment specified below. The customer or user of the 790 series cordless illumination system should assure that it is used in such an environment.
- Page 25 Directions for use Cordless illumination system Table 3. Electromagnetic immunity (continued) Note 1: At 80 MHz and 800 MHz, the higher frequency range applies. Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy.
- Page 26 Welch Allyn Table 4. Recommended separation distances between portable and mobile RF communications equipment and the 790 series cordless illumination system The 790 series cordless illumination system is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or user of the 790 series cordless...
- Page 28 4341 State Street Road, PO Box 220, Skaneateles Falls, NY 13153-0220 USA 1 800 535 6663, + 1 315 685 4560 www.welchallyn.com Mat. Number: 707021, Ver: D...
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