Welch Allyn KleenSpec User Manual [en, de, es, fr, it]

KleenSpec® 790 Series

Cordless Illumination System

for the 590 Series Vaginal Speculum

REF 79910

Directions for use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Mode d’emploi (Français) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23 Instrucciones de uso (Español) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39 Instruções de utilização (Português) . . . . . . . . . . . . . . . . . . . . . . . . . 55 Gebrauchsanleitung (Deutsch) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71 Gebruikshandleiding (Nederlands) . . . . . . . . . . . . . . . . . . . . . . . . . . . 87 Brugsanvisning (Dansk) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103 Istruzioni per l'uso (Italiano). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119 Bruksanvisning (Svenska) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 137 Brukerhåndbok (Norsk). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 153

:VND]µZNL GRW\F]ÇFH Xľ\WNRZDQLD 3ROVNL . . . . . . . . . . . . 169

Käyttöohjeet (Suomi) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 185 ˍˡˤˠ˜ˢ˯ ˴ˮ˛˰ˤ˯ ˃˨˨ˤ˪˦˧˙ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 201

ii

© 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: 718914, Ver: A

Welch Allyn

4341 State Street Road, PO Box 220

Skaneateles Falls, NY 13153-0220

www.welchallyn.com

Printed in USA

1

Directions for use

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
(base and power cord)

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.

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.

Shipping, storing, and environment symbols

This end up		Keep dry
Fragile	95%	Relative humidity limit

15%

+49 C Temperature limits

-20 C

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Certification symbols

					Meets essential requirements of European Medical Device Directive
					93/42/EEC.
					Regulatory Affairs Representative
		EC	REP
					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

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 10.
	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. For operation time limits, see “Intermittent operation” on page 13.

•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.

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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.

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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 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 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 14.

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7

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.

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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.	b
Connect the auxiliary power cord to
illuminator (b). Reinsert the
illuminator.

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).

Power

switch

Note For operation time limits, see “Intermittent operation” on page 13”.

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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.

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.

3.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.

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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 14.

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	Charging base is not plugged in. Connect charging
in the charging base.	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	Australia	+ 6129 638 3000
	+ 1 315 685 4560
Canada	1	800 561 8797	China	+ 86 216 327 9631
European Call Center	+ 353 46 906 7790		France	+ 3315 569 5849
Germany	+ 49 747 792 7186		Japan	[phone]
Latin America	+ 1 305 669 9003		Netherlands	+ 31 202 061 360
Singapore	+ 656 419 8100		South Africa	+ 2711 777 7555
United Kingdom	+ 44 207 365 6780		Sweden	+ 46 85 853 6551

12 Directions for use Welch Allyn

Appendix

Specifications

	Item	Specification
	Auxiliary power cord transformer	U.S. & Canada	International
	Classification	Class II and internally pow-	Class I and internally pow-
		ered, type BF applied part	ered, type BF applied part
	Input	120 V ~ 60 Hz	100 - 240 VAC 200-100 mA
	Output	5.5 VDC, 300 mA	5.5 VDC, 300 mA
	Category	Not AP/APG equipment	Not AP/APG equipment
	Charging station transformer	U.S. & Canada	International
	Classification	Class I and internally	Class I, Class II and internally
		powered	powered
	Input	120 V ~ 60 Hz	230 V (240 V in Australia) ~
		9.8 VDC, 150 mA	50 Hz
	Output		7.5 – 9.2 VDC , 200 mA
		Not AP/APG equipment
	Category		Not AP/APG equipment
	Power cord length
	Auxiliary power cord	305 cm (120 in)
	Charging station	92 cm (36 in)
	Weight
	Illuminator	48 g (0.1 lb)
	Charging station	142 g (0.31 lb)
	(base and power cord)
	Auxiliary power cord	290 g (0.64 lb)
	Battery cell
	Capacity	420 mAh
	Voltage	3.7 V
	Chemistry	Li-ion (single lithium ion)

Directions for use	Cordless illumination system	13
Protection against ingress of	IPXØ
water, per IEC 60529 (illuminator,
auxiliary power cord, charging
station)
Operating conditions
Temperature	+10° C to +35° C (+50° F to +95° F)
Relative humidity	30% to 75% noncondensing
Altitude	700 to 1060 hPa
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
Illuminator with speculum	10 minutes on, 5 minutes off between uses
Illuminator alone	2 minutes on, 5 minutes off between uses
Safety, EMC, and regulatory	CAN/CSA C22.2 No. 601.1-M90, including amendments 1 &
compliance	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

14 Directions for use Welch Allyn

Part Numbers

Item	Order Number	REF
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. & Canada:	79900
Charging station	U.S. & Canada:	73910
(base and power cord)	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.

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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	Group 1	The 790 series cordless illumination system uses RF energy
	CISPR 11		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	Class B	The 790 series cordless illumination system is suitable for
	CISPR 11		use in all establishments including domestic and those
			directly connected to the public low-voltage power supply
	Harmonic emissions	Class A
			network that supplies buildings used for domestic
	IEC 61000-3-2
			purposes.
	Voltage fluctuations/	Complies
	flicker emissions
	IEC 61000-3-3

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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.

Immunity test	IEC 60601	Compliance	Electromagnetic environment -
	test level	level	guidance
Electrostatic	± 6 kV contact	± 6 kV contact	Floors should be wood, concrete, or
discharge (ESD)	± 8 kV air	± 8 kV air	ceramic tile. If floors are covered with
IEC 61000-4-2			synthetic material, the relative
			humidity should be at least 30%.
Electrical fast	±2 kV mains	±2 kV mains	Mains power quality should be that of
transient (EFT)/	±1 kV I/O	Not applicable	a typical commercial or hospital
burst			environment.
IEC 61000-4-4
Surge	±1 kV differential	±1 kV differential	Mains power quality should be that of
IEC 61000-4-5	±2 kV common	±2 kV common	a typical commercial or hospital
			environment.
Voltage dips, short	>95% dip in	>95% dip in	Mains power quality should be that of
interruptions, and	0.5 cycle	0.5 cycle	a typical commercial or hospital
voltage variations			environment. If the user of the 790
on power supply	60% dip in	60% dip in	series cordless illumination system
input lines.	5 cycles	5 cycles	requires continued operation during
IEC 61000-4-11			power mains interruptions, it is
	30% dip for	30% dip for	recommended that the 790 series
	25 cycles	25 cycles	cordless illumination system be
			powered from an uninterruptible
	>95% dip in	>95% dip in	power supply or battery.
	5 seconds	5 seconds
Power frequency	3 A/m	3 A/m	Power frequency magnetic fields
(50/60Hz)			should be at levels characteristic of a
magnetic field			typical location in a typical
IEC 61000-4-8			commercial or hospital environment.

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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.

Immunity	IEC 60601	Compliance	Electromagnetic environment - guidance
test	test level	level
			Portable and mobile RF communications equipment
			should be used no closer to any part of the 790 series
			cordless illumination system, including cables, than the
			recommended separation distance calculated from the
			equation applicable to the frequency of the transmitter.
			Recommended separation distance
Conducted	3 Vrms	3 Vrms	d = (1.17)	P
RF, IEC	150 kHz to
61000-4-6	80 MHz
Radiated	3 V/m	3 V/m	d = (1.17)	P 80 MHz to 800 MHz
RF, IEC	80 MHz to		d = (2.33)	P 800 MHz to 2.5 GHz
61000-4-3	2.5 GHz
			where P is the maximum output power rating of the
			transmitter in watts according to the transmitter
			manufacturer and d is the recommended separation
			distance in meters.
			Field strengths from fixed RF transmitters, as
			determined by an electromagnetic site survey,a should
			be less than the compliance level in each frequency
			range.b
			Interference may occur in the vicinity of equipment
			marked with the following symbol:

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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.

aField 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. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the 790 series cordless illumination system is used exceeds the applicable RF compliance level above, the 790 series cordless illumination system should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the 790 series cordless illumination system.

bOver the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

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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 illumination system can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the 790 series cordless illumination system as recommended below, according to the maximum output power of the communications equipment.

	Rated max.	Separation distance according to frequency of transmitter (m)
	output power
	of transmitter	150 kHz to 80 MHz	80 MHz to 800 MHz	800 MHz to 2.5 GHz
		d = (1.17) P	d = (1.17) P	d = (2.33) P
	(W)
	0.01	0.117	0.117	0.233
	0.1	0.37	0.37	0.74
	1	1.17	1.17	2.33
	10	3.70	3.70	7.37
	100	11.70	11.70	23.30

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

Note 1: At 80 MHz and 800 MHz, the separation distance for 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.

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Directions for use

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Mode d’emploi (Français)

Introduction

Le système d’éclairage sans fil Welch Allyn KleenSpec® 790 peut être utilisé avec ou sans le spéculum vaginal jetable KleenSpec 590. Ce système d’éclairage sans fil se compose des éléments suivants :

Illuminateur sans fil

Chargeur	Cordon
(base et cordon d’alimentation)

Utilisation prévue

Dans le cadre d’une utilisation avec le spéculum vaginal, l’illuminateur sans fil fournit un éclairage pendant les examens pelviens et autres procédures gynécologiques, comme le frottis Papanicolaou, la biopsie dilation et curetage (DC) et l’électrochirurgie.

L’illuminateur sans fil peut être utilisé indépendamment du spéculum comme source lumineuse d’utilisation générale.

Contre-indications

L’illuminateur 790 (seul ou conjointement avec un spéculum 590) n’est pas conçu pour un examen de la vue.

L’illuminateur 790 (seul ou conjointement avec un spéculum 590) n’est pas conçu pour un diagnostic.

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Mode d’emploi (Français)

Welch Allyn

Profil d’utilisateur

Les illuminateurs s’adressent à des professionnels de la médecine qualifiés pour effectuer un examen pelvien.

Symboles

Les symboles illustrés sur les pages suivantes peuvent apparaître dans ce manuel ou sur l’illuminateur, le chargeur, le cordon d’alimentation auxiliaire, l’emballage ou le conteneur d’expédition.

Symboles de la documentation

		AVERTISSEMENT	Dans ce manuel, ce symbole et « AVERTISSEMENT »
			indiquent des conditions ou pratiques pouvant entraîner une
			maladie, des blessures ou éventuellement la mort.
		Attention	Dans ce manuel, ce symbole et « Attention » indiquent des
			conditions ou pratiques susceptibles d’endommager le
			matériel ou tout autre bien.
			Sur le produit, ce symbole signifie qu’il faut se reporter au
			mode d’emploi.
Symboles d’expédition, de stockage et d’environnement
		Haut		Conserver dans un endroit sec
		Fragile	95%	Limite d’humidité relative

15%

+49 C Limites de température

-20 C

Mode d’emploi (Français)

Système d'éclairage sans fil

25

Symboles de certification

REP CE

N344

Conforme aux exigences essentielles de la directive européenne relative aux dispositifs médicaux 93/42/CEE.

Représentant des affaires réglementaires

Welch Allyn Limited

Navan Business Park, Dublin Road

Navan, County Meath, Republic of Ireland

CERTIFIÉ : CAN/CSA STD C22.2 NO. 601.1

CONFORME À : CEI 60601-1, CEI 60601 1- 2, UL 60601-1

Structure CEM en Australie

Symboles de fonctionnement

	Attention, températures élevées
	Le spéculum est une pièce appliquée de type BF.
	Courant alternatif
	Courant continu
	Isolation double
IPXØ	L’appareil n’est pas étanche
	Recycler ce produit séparément des autres produits jetables. Voir
	« Recyclage des composants du système » page 32.
	Prise

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Mode d’emploi (Français)

Welch Allyn

Utilisation du système en toute sécurité

Avant d’utiliser le système d’éclairage sans fil, il convient de lire et comprendre les informations de sécurité suivantes.

Avertissements généraux

Les avertissements suivants s’appliquent à l’utilisation du système d’éclairage sans fil en général. Les avertissements qui s’appliquent spécifiquement à des procédures particulières, comme le nettoyage, apparaissent dans les sections correspondantes du manuel.

Des avertissements indiquent des conditions ou pratiques susceptibles d’entraîner une maladie, des blessures ou éventuellement la mort.

AVERTISSEMENT pour éviter tout risque de choc électrique, cet équipement doit uniquement être raccordé à une alimentation secteur avec mise à la terre.

AVERTISSEMENT aucune modification de cet équipement n'est autorisée.

AVERTISSEMENT L’illuminateur peut générer de la chaleur après une utilisation prolongée. Pour connaître les limites de délais de fonctionnement, voir « Fonctionnement discontinu » page 35.

•L’illuminateur peut être dangereux pour la peau s’il est touché après avoir fonctionné pendant une longue durée.

•Pour écarter tout risque d’incendie, ne pas placer l’illuminateur sur une surface inflammable si la DÉL est allumée.

•L’illuminateur n’est pas conçu pour une utilisation en présence d’un mélange anesthésique inflammable avec l’air, l’oxygène ou le protoxyde d’azote. Une explosion pourrait se produire.

Mode d’emploi (Français)

Système d'éclairage sans fil

27

AVERTISSEMENT Pour éviter tout risque d’électrocution, la prise de courant doit être correctement reliée à la terre. La mise à la terre n’est fiable que lors d’une connexion à des prises de qualité ou d’utilisation hospitalière.

AVERTISSEMENT L’illuminateur n’est pas conçu pour des examens de la vue.

AVERTISSEMENT L’illuminateur n’est pas conçu pour un diagnostic.

AVERTISSEMENT L’illuminateur est conçu pour être utilisé par des professionnels de la médecine qualifiés.

AVERTISSEMENT Un bloc d'alimentation et/ou un cordon d'alimentation, destinés à une utilisation avec ce produit seulement, sont fournis avec le produit. Le bloc d'alimentation et/ou le cordon d'alimentation n'ont pas été testés et approuvés pour une utilisation avec d'autres produits qui pourraient être munis des mêmes connecteurs d'alimentation. Si vous n'avez plus le bloc d'alimentation et/ou le cordon d'alimentation originaux, veuillez contacter Welch Allyn pour obtenir des pièces de remplacement.

Précautions générales

Les signalements « attention » suivants s’appliquent à l’utilisation du système d’éclairage sans fil en général. Les signalements

«attention » qui s’appliquent spécifiquement à des procédures particulières, comme des examens pelviens, apparaissent dans les sections correspondantes du manuel.

«Attention » indique des conditions ou pratiques susceptibles d’endommager le matériel ou tout autre bien.

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Mode d’emploi (Français)

Welch Allyn

Attention débranchez le cordon d’alimentation pour couper le courant au niveau de l'appareil.

Attention L’illuminateur sans fil peut présenter un danger de contamination après utilisation. Respecter les bonnes pratiques hospitalières. Voir « Nettoyage et désinfection » page 31.

Attention L’illuminateur sans fil, le chargeur et le cordon d’alimentation auxiliaire ne sont pas étanches.

Attention Ce dispositif ne comporte aucune pièce pouvant être réparée par l’utilisateur. En cas de dysfonctionnement, appeler Welch Allyn et décrire le problème avec précision.

Attention Ce dispositif est conforme aux normes en vigueur exigibles en matière de brouillage électromagnétique et ne devrait ni provoquer d’interférences ni en recevoir de la part d’autres équipements. Par mesure de précaution, éviter d’installer l’appareil à proximité d’autres équipements.

Attention Utiliser uniquement des pièces autorisées par Welch Allyn. Voir « Numéros de référence » page 36.