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KleenSpec® 790 Series
Cordless Illumination System
for the 590 Series Vaginal Speculum
REF 79910
Directions for Use
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© 2012 Welch Allyn. All rights are reserved. To support the intended use of the product described in this publication, the purchaser of the product is permitted to copy this publication, for internal distribution only,from the media provided by Welch Allyn.
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.
Welch Allyn and KleenSpec are registered trademarks of Welch Allyn. CaviWipe is a registered trademark of Metrex Research Corporation.
Caution: Changes or modifications not expressly approved by Welch Allyn could void the purchaser's authority to operate the equipment.
Patents pending.
Mat. Number: 718913 , Ver: A
Welch Allyn
4341 State Street Road, PO Box 220
Skaneateles Falls, NY 13153-0220
www.welchallyn.com
Printed in USA
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Contents
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 User profile . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Using the system safely . . . . . . . . . . . . . . . . . . . . . . . . 4 Utilisation sécuritaire du système . . . . . . . . . . . . . . . . . 7
Charging the illuminator . . . . . . . . . . . . . . . . . 10
Using the illuminator for a pelvic exam . . . . . 11
Using the illuminator as light source . . . . . . . 11
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Cleaning and disinfecting. . . . . . . . . . . . . . . . . . . . . . . 12 Inspecting the system . . . . . . . . . . . . . . . . . . . . . . . . . 13 Recycling the system components . . . . . . . . . . . . . . . 13
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . 14
Contacts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Appendix. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 Part numbers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 Limited warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18 Service policy. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 EMC guidance and manufacturer’s declarations . . . . . 20
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Directions for use |
Cordless illumination system |
1 |
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 illuminator
Charging station |
Auxiliary power cord |
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(optional) |
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(base and power cord) |
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Intended use
When used with the vaginal speculum, the cordless illuminator provides illumination during pelvic examinations and other gynecological procedures, such as pap smears, dilation and curettage (D&C) biopsy, and electrosurgery.
The cordless illuminator can be used independent of the speculum as a general-purpose light source.
Contraindications
The 790 series illuminator (either by itself or in conjunction with a 590 series speculum) is not intended to be used for eye examinations.
The 790 series illuminator (either by itself or in conjunction with a 590 series speculum) is not intended to be used for diagnosis.
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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.
Table 1. Documentation symbols
WARNING In this manual, this symbol and “WARNING” indicate conditions or practices that could lead to illness, injury, or death.
Caution In this manual, this symbol and “Caution” indicate conditions or practices that could damage the equipment or other property.
On the product, this symbol means consult operating instructions.
Table 2. Shipping, storing, and environment symbols
This end up |
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Keep dry |
Fragile |
95% |
Relative humidity limit |
15%
+49 C Temperature limits
-20 C 
Directions for use |
Cordless illumination system |
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Table 3. Certification symbols
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Meets essential requirements of European Medical Device Directive |
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93/42/EEC. |
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Regulatory Affairs Representative |
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EC |
REP |
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Welch Allyn Limited |
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Navan Business Park |
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Dublin Road, Navan |
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County Meath, Republic of Ireland |
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CERTIFIED TO: CAN/CSA STD C22.2 NO. 601.1 |
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CONFORMS TO: IEC 60601-1, IEC60601-1-2, UL 60601-1 |
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EMC framework of Australia |
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N344 |
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Table 4. Operation symbols
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Caution, hot surface |
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The speculum is a Type BF applied part |
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Alternating current |
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Direct current |
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Double insulation |
IPXØ |
Not protected from the ingress of liquid. |
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Recycle the product separately from other disposables. See “Recycling |
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the system components” on page 13. |
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Power plug |
4 |
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.
Warning statements indicate conditions or practices that could lead to illness, injury, or death.
WARNING To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth.
WARNING No modification to this equipment is allowed.
WARNING The illuminator may generate heat after prolonged use.
•Operation time limits: Illuminator with speculum10 minutes on, 5 minutes off between uses. Illuminator alone 2 minutes on, 5 minutes off between uses.
•Illuminator could be harmful to skin if touched after being on for extended times.
•To avoid fire, do not place illuminator onto a flammable surface if LED is on.
•Illuminator is not suitable for use in the presence of a flammable anesthetic mixture with air or oxygen or nitrous oxide. An explosion may result.
Directions for use |
Cordless illumination system |
5 |
WARNING To prevent shock hazards, the power outlet must be properly grounded. Grounding reliability is achieved only when connected to hospital-use or hospital-grade receptacles.
WARNING The illuminator is not intended to be used for eye examinations.
WARNING The illuminator is not intended to be used for diagnosis.
WARNING The illuminator is intended to be used by trained medical professionals.
WARNING This product comes with a power supply and/or power cord that is intended for use only with this product. The power supply and/or power cord have not been tested and approved for use with other products that may have the same power connectors. If you cannot locate the original power supply and/or power cord, please contact Welch Allyn to obtain replacement parts.
General cautions
The following caution statements apply to use of the cordless illumination system in general. Caution statements that apply specifically to particular procedures, such as pelvic examinations, appear in the corresponding sections of the manual.
Caution statements indicate conditions or practices that could damage the equipment or other property.
Caution Disconnect the AC power cord to remove power to the device.
Caution The cordless illuminator could be a biohazard after use. Follow good hospital practices. See “Cleaning and disinfecting” on page 12.
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.
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Welch Allyn |
Caution This device complies with current required standards for electromagnetic interference and should not present problems to other equipment or be affected by other devices. As a precaution, avoid using this device in close proximity to other equipment.
Caution Use only Welch Allyn-approved parts. See “Part numbers” on page 17.
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