KleenSpec 790 Series Directions for Use Ver A

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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

Directions for use

Cordless illumination system

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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 (base and power cord)

Auxiliary power cord (optional)

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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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

Keep dry

Fragile

95%

15%

+49C

-20C

Temperature limits

Relative humidity limit

Directions for use

Cordless illumination system

Table 3. Certification symbols Meets essential requirements of European Medical Device Directive 93/42/EEC. EC REP

Regulatory Affairs Representative Welch Allyn Limited Navan Business Park Dublin Road, Navan County Meath, Republic of Ireland CERTIFIED TO: CAN/CSA STD C22.2 NO. 601.1 CONFORMS TO: IEC 60601-1, IEC60601-1-2, UL 60601-1

EMC framework of Australia N344

Table 4. Operation symbols Caution, hot surface The speculum is a Type BF applied part Alternating current Direct current Double insulation

IPXØ

Not protected from the ingress of liquid. Recycle the product separately from other disposables. See “Recycling the system components” on page 13. Power plug

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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 speculum  10 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

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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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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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Charging the illuminator Charge the illuminator before using it the first time, or whenever its low-charge indicator turns on.

LED Power switch Low-charge indicator: On = battery low

To charge the illuminator 1. If LED is lit, turn power switch off. 2. Connect charging base to AC power. 3. Place the illuminator (either direction) into the charging station. Full charging takes 6 to 8 hours.

Status indicator: Off = no AC power Green = AC power Amber (illuminator inserted) = charging. Full charging takes 6 to 8 hours.

4. Remove the charged illuminator when you are ready to use it. It is safe to leave the illuminator in the charging station after it is charged.

Directions for use

Cordless illumination system

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Using the illuminator for a pelvic exam 1. 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. Do either of these things: •

a

Leave the illuminator in place, and use an external light source. or

•

Connect the auxiliary power cord to AC power. Hold the speculum in place, and remove the illuminator. Connect the auxiliary power cord to illuminator (b). Reinsert the illuminator.

b

4. When finished, remove the speculum, and then remove the illuminator. The LED automatically turns off.

Using the illuminator as light source To use the illuminator as a light source, slide the power switch to turn it on (all the way down) and off (all the way up). Note

For operation time limits, see “Intermittent operation” on page 16.

Power switch

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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. Clean the illuminator prior to disinfection.

To clean and disinfect the illuminator 1.

After using the illuminator, unplug any power cords.

2.

Clean the illuminator.

3.

a.

Following the wipe manufacturer's instructions, wipe the entire unit to completely remove any gross debris.

b.

Gently wipe the gold contacts on the bottom with 70% alcohol. If debris builds up on these contacts, the charging or auxiliary power functions might be affected.

Disinfect the illuminator. a.

Following the wipe manufacturer's instructions, thoroughly wet the surface of the entire illuminator.

b.

Using sterile gauze soaked with 70% isopropyl alcohol, thoroughly wet the surface of the entire illuminator. The treated surface must remain wet for five minutes. If needed, reapply the solution to keep the surface continuously wet during this time.

c.

Allow the surface to dry.

To clean the charging base or auxiliary power cord 1.

After using the charging base or auxiliary power cord, unplug the power cord.

2.

Clean the component. Following the wipe manufacturer's instructions, wipe the surface to completely remove any gross debris.

Directions for use

Cordless illumination system

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Inspecting the system Examine all components of the cordless illumination system monthly. Components include the illuminator, charging station, and auxiliary power cord. If any component is worn or damaged, replace it with the Welch Allyn-approved part. For ordering information, see “Part numbers” on page 17.

Recycling the system components Within the EU Do not dispose of this product as unsorted municipal waste. Prepare it for reuse or separate collection as specified by Directive 2002/96/EC of the European Parliament and the Council of the European Union on Waste Electronic and 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 product to Welch Allyn.

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Troubleshooting If you try these suggestions and still have problems, contact Welch Allyn. Problem

Probable causes & solutions

LED does not light.

Battery is low. Charge the illuminator. Illuminator is not seated correctly in speculum. Insert illuminator fully into speculum.

LED does not light when the auxiliary power cord is attached.

Auxiliary power cord is not plugged in. Plug the auxiliary power cord into an AC outlet. Auxiliary power cord is not seated properly. Plug the cord into the illuminator properly.

LED does not automatically turn off when removing the illuminator from the speculum.

Power switch is damaged or blocked. Clean the switch area. If the problem continues, replace the illuminator.

Illuminator does not charge in the charging base.

Charging base is not plugged in. Connect charging base to AC power. 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: USA

1 800 535 6663 + 1 315 685 4560 Canada 1 800 561 8797 European Call Center + 353 46 906 7790 Germany + 49 747 792 7186 Latin America + 1 305 669 9003 Singapore + 656 419 8100 United Kingdom + 44 207 365 6780

Australia

+ 6129 638 3000

China France Japan Netherlands South Africa Sweden

+ 86 216 327 9631 + 3315 569 5849 + 81 42 703 6084 + 31 202 061 360 + 2711 777 7555 + 46 85 853 6551

Directions for use

Cordless illumination system

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Appendix Specifications Item

Specification

Auxiliary power cord transformer Classification

U.S. & Canada Class II and internally powered, type BF applied part 120 V ~ 60 Hz 5.5 VDC, 300 mA Not AP/APG equipment

International Class I and internally powered, type BF applied part 100 - 240 VAC 200-100 mA 5.5 VDC, 300 mA Not AP/APG equipment

Input

U.S. & Canada Class I and internally powered 120 V ~ 60 Hz

Output Category

9.8 VDC, 150 mA Not AP/APG equipment

International Class I, Class II and internally powered 230 V (240 V in Australia) ~ 50 Hz 7.5 – 9.2 VDC , 200 mA Not AP/APG equipment

Input Output Category Charging station transformer Classification

Power cord length Auxiliary power cord Charging station Weight Illuminator Charging station (base and power cord) Auxiliary power cord Battery cell Capacity Voltage Chemistry

305 cm (120 in) 92 cm (36 in) 48 g (0.1 lb) 142 g (0.31 lb) 290 g (0.64 lb) 420 mAh 3.7 V Li-ion (single lithium ion)

Protection against ingress of IPXØ water, per IEC 60529 (illuminator, auxiliary power cord, charging station) Operating conditions Temperature Relative humidity Altitude

+10° C to +35° C (+50° F to +95° F) 30% to 75% noncondensing 700 to 1060 hPa

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Item (continued)

Specification (continued)

Shipping and storage conditions Temperature Relative humidity Altitude

-20° C to +49° C (-4° F to +120° F) 15% to 95% noncondensing 500 hPa to 1060 hPa

Intermittent operation Illuminator with speculum Illuminator alone

10 minutes on,  5 minutes off between uses  2 minutes on,  5 minutes off between uses

Safety, EMC, and regulatory compliance

CAN/CSA C22.2 No. 601.1-M90, including amendments 1 & 2 EN/IEC 60601-1 EN/IEC 60601-1-2 EN/IEC 60825-1 UL 60601-1 AS/NZS CISPR11

LED radiation output

< 6.67 mW at 400 – 700 nm wavelengths

Directions for use

Cordless illumination system

Part numbers Item

Order Number REF

Cordless illuminator system with charging station

U.S. & Canada: 79910 International: 79915*

Cordless illuminator system with charging station and auxiliary power cord

U.S. & Canada: 79920 International: 79925*

Cordless illuminator

U.S. & Canada: 79900

Charging station (base and power cord)

U.S. & Canada: 73910 International: 73915*

Auxiliary power cord

U.S. & Canada: 75910 International: 75915*

* Specify country and voltage.

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Limited warranty Welch Allyn warrants that the KleenSpec vaginal speculum cordless illumination system products meet the labeled specifications of the Products and will be free from defects in materials and workmanship that occur within one year after the date of purchase. The date of purchase is the date specified in our records, if you purchased the Product directly from us or 30 days after the date on which the Product was sold to the dealer from whom you bought the Product, as documented in our records. This warranty does not cover damage caused by: 1) handling during shipping, 2) use or maintenance contrary to labeled instructions, 3) alteration or repair by anyone not authorized by Welch Allyn, and 4) accidents. If a Product or accessory covered by this warranty is determined to be defective because of defective materials, components, or workmanship, and the warranty claim is made within the warranty period described above, Welch Allyn will, at its discretion, repair or replace the defective 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. You must obtain a return authorization from Welch Allyn to return your Product before you send it to Welch Allyn’s designated service center for repair. Contact Welch Allyn Technical Support. THIS WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO THE IMPLIED WARRANTIES OF MERCHANTABILTY AND FITNESS FOR A PARTICULAR PURPOSE. WELCH ALLYN'S OBLIGATION UNDER THIS WARRANTY IS LIMITED TO REPAIR OR REPLACEMENT OF PRODUCTS CONTAINING A DEFECT. WELCH ALLYN IS NOT RESPONSIBLE FOR ANY INDIRECTOR CONSEQUENTIAL DAMAGES RESULTING FROM A PRODUCT DEFECT COVERED BY THE WARRANTY.

Directions for use

Cordless illumination system

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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. If the product fails to function properly - or if you need assistance, service, or spare parts - contact Welch Allyn. Before contacting Welch Allyn, try to duplicate the problem, and check all accessories to ensure that they are not causing the problem. When calling, please be prepared to provide: • • • •

Product name and model number and complete description of the problem. Serial number of your product (if applicable). Complete name, address and phone number of your facility. For out-of-warranty repairs or spare parts orders, a purchase order (or credit card) number. • For parts orders, the required spare or replacement part numbers. If your product requires warranty, extended warranty, or non-warranty repair service, please call Welch Allyn. A representative will assist you troubleshooting the problem and will make every effort to solve it over the phone, avoiding potential unnecessary returns. In case a return cannot be avoided, the representative will record all necessary information and will provide a Return Material Authorization (RMA) number, as well as the appropriate return address. An RMA number must be obtained prior to any return. If you have to return goods for service, follow these recommended packing instructions: • Remove all hoses, cables, sensors, power cords, and ancillary products (as appropriate) before packing, unless you suspect they are associated with the problem. • Wherever possible use the original shipping carton and packing materials. • Include a packing list and the Welch Allyn Return Material Authorization (RMA) number. It is recommended that all returned goods be insured. Claims for loss or damage to the product must be initiated by the sender.

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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. Emissions test

Compliance Electromagnetic environment - guidance

RF emissions CISPR 11

Group 1

The 790 series cordless illumination system uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

RF emissions CISPR 11

Class B

The 790 series cordless illumination system is suitable for use in all establishments including domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Harmonic emissions Class A IEC 61000-3-2 Voltage fluctuations/ Complies flicker emissions IEC 61000-3-3