Contents Introduction ..................... 1 Intended use ......................1 Contraindications ....................1 Symbols ....................... 1 Warnings and cautions ..................3 Use and maintain the illuminator ............5 Charge the illuminator ..................5 Use the illuminator for a pelvic examination ............6 Clean and disinfect ....................
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® iv Contents Welch Allyn KleenSpec 800 Series Cordless Illumination System...
When used with the KleenSpec Disposable Vaginal Speculum (vaginal speculum), ® Welch Allyn KleenSpec 800 Series Cordless Illumination System (the illuminator) provides illumination during pelvic examinations and other gynecological procedures, such as pap smears, dilation and curettage (D&C) biopsy, and electrosurgery. Contraindications ®...
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® 2 Introduction Welch Allyn KleenSpec 800 Series Cordless Illumination System Symbol Description Symbol Description For use by or on the order of a This way up licensed medical professional Manufacturer Fragile Separate collection of Electrical Temperature limit and Electronic Equipment. Do not dispose as unsorted municipal waste.
The power supply or power cord have not been tested and approved for use with other devices that may have the same power connectors. If you cannot locate the original power supply and/or power cord, contact Welch Allyn Technical Support: www.welchallyn.com/about/company/locations.htm obtain replacement parts.
Use and maintain the illuminator Charge the illuminator Charge the illuminator before using it the first time. 4-5 hr 1. Connect the charging base to AC power. 2. Place the illuminator (either direction) into the charging station. 3. Remove the charged illuminator when you are ready to use it. Full charging takes 4 to 5 hours.
® 6 Use and maintain the illuminator Welch Allyn KleenSpec 800 Series Cordless Illumination System Use the illuminator for a pelvic examination 1. Fully insert the illuminator into a KleenSpec Disposable Vaginal Speculum (in either direction). 2. Press the power button on the illuminator.
1. Examine all components of the cordless illumination system regularly. Components include the illuminator and charging base. 2. If any component is worn or damaged, replace it with a Welch Allyn-approved part. For ordering information, contact your local Welch Allyn representative:...
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® 8 Use and maintain the illuminator Welch Allyn KleenSpec 800 Series Cordless Illumination System...
Appendices Appendix A: Specifications Charging station power supply classification: US, Canada, & International; Class I and internally powered Characteristic Specification Input 100-240v / 50-60Hz 160-80 mA Output 5v DC 1400 mA Category Not AP/APG Equipment Physical specifications Characteristic Specification Illuminator 1.96 W x 1.37 D x 3.74 H in;...
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® 10 Appendices Welch Allyn KleenSpec 800 Series Cordless Illumination System Environment (temperature and humidity) Characteristic Specification Operating +10°C (50°F) and +35°C (95°F) 700 hPa - 1060 hPa 30% - 75% non-condensing Transport/Storage –20°C (-4°F) and +49°C (120°F) 500 hPa - 1060 hPa...
Emissions and immunity information Electromagnetic emissions The Welch Allyn KleenSpec 800 Series is intended for use in the electromagnetic environment specified below. The customer or user of the 800 Series should assure that it is used in such an environment.
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Directions for use Appendices 13 Electromagnetic emissions RF emissions Class B The 800 Series is suitable for use in all establishments, including CISPR 11 domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes.
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® 14 Appendices Welch Allyn KleenSpec 800 Series Cordless Illumination System Electromagnetic immunity 70 % U ; 25/30 cycles 70 % U ; 25/30 cycles Single phase: at 0° 0 % U ; 250/300 cycle 0 %U ; 250/300 cycle...
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Directions for use Appendices 15 Electromagnetic immunity The 800 Series is intended for use in the electromagnetic environment specified below. The customer or the user of the 800 Series should assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance level Electromagnetic environment - guidance...
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® 16 Appendices Welch Allyn KleenSpec 800 Series Cordless Illumination System Recommended separation distances between portable and mobile RF communications equipment and the 800 Series The 800 Series is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
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Directions for use Appendices 17 Test specifications for enclosure port immunity to RF wireless communications equipment iDEN 820, CDMA 850, LTE Band 5 1720 1700 - 1990 GSM 1800; Pulse modulation CDMA 1900; 217 Hz GSM 1900; 1845 DECT; LTE Band 1, 3, 4, 25;...
KleenSpec 800 Series Cordless Illumination System Appendix D: Limited warranty Welch Allyn warrants the product to be free of defects in material and workmanship and to perform in accordance with manufacturer's specifications for the period of one year from the date of purchase from Welch Allyn or its authorized distributors or agents.