Welch Allyn Solarc Light Source User Manual [en, de, es, fr, it]

MANUAL, REF LB24M INTERNATIONAL

English . . . . . . . .1

Français . . . . . . 31

Español . . . . . .61

Português . . . .91

Deutsch . . . . .121

Italiano . . . . . .153

日本語

中文

. . . . . . .183

. . . . .. . 211

CaviCide® is a registered trademark of Metrex Research Corporation (800) 841-1428.

is a registered trademark of Reckitt Benckiser (800) 677-9218.

L ysol

larc® is a registered trademark of Welch Allyn, Inc. (800) 535-6663.

Table of Contents

Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Indications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

User Profile. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Symbol Description. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Warnings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

Cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

System Description and Operation . . . . . . . . . . . . . . . .11

Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13

Lamp Replacement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

Ordering Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .19

Electrical . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

Dimensions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

Illumination System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

Environment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

Equipment Classification . . . . . . . . . . . . . . . . . . . . . . . . . . 20

Patents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

Approvals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

Emissions and Immunity Information. . . . . . . . . . . . . . . . . 22

Warranty and Service . . . . . . . . . . . . . . . . . . . . . . . . . 27

Warranty. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28

2 Welch Allyn Light Source

Introduction

This manual describes the setup, installation, start-up, and use of the Welch Allyn Light Source.

Indications

Use of the Welch Allyn Light Source is indicated for medical lighting applications requiring a remotely located, high-quality white light. This product must only be used by qualified medical personnel.

Contraindications

The use of the W elch Allyn Light Source is contraindicated for applications where high intensity light might burn or damage tissues; such as for neonate transillumination and ophthalmic procedures.

For further contraindications, the user must also consult the operating manual of the instrumen t being used with the Light Source in the medical procedure.

User Profile

This product must only be used by qualified medical personnel.

4 Chapter 1 Introduction Welch Allyn Light Source

3045357

Symbol Description

IPXØ

MAX

Caution: Consult accompanying

Not AP/APG Equipment

documentation

Light; Lighting; Illumination

Caution, Hot Surface

Intensity

Not Protected Against the

Bright Light

Ingress of Water

Type BF Equipment Alternating Current

Filter In / Filter Out Indoor/dry location use only

Lamp On Lamp Off

Storage Humidity Transport Temperature

ITS, Nationally Recognized Testing Laboratory (NRTL) Mark

UL Recognized Component Mark

Direct Current Double Insulation

Directions for Use Chapter 1 Introduction 5

European CE Mark

Caution Hazard Warning

Recycling Symbol- Do not dispose of this product as unsorted municipal waste. Prepare this product 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. See www.welchallyn.com/weee or contact Welch Allyn Customer Service.

EMC Framework of Australia

N344

6 Chapter 1 Introduction Welch Allyn Light Source

Warnings

A warning statement in this manual identifies a condition or practice which, if not corrected or discontinued immediately, could lead to patient injury, illness or death.

WARNING RISK OF FIRE. Do not operate on, near, or over combustible material. Operate only on smooth, hard, flat surface. This device is not suitable for use in the presence of a flammable anesthetic mixt ure with air or oxygen or nitrous oxide. An explosion may result.

WARNING The high intensity light at the front of the light source and at the tip of the fiber optic bundle will create high temperatures and bright light. To minimize the risk of injury, avoid direct viewing or contact with sensitive tissues.

WARNING Do not use for neonate transillumination. Erythema may result.

WARNING To prevent temporary blinding, always plug the fiber optic bundle into the Welch Allyn Light Source and set the light intensity control to minimum before turning the power ON.

WARNING If this light source is used during invasive surgery, the failure of a component within the system, causing loss of illumination, may indirectly cause risk to the patient. Therefore, it is recommended to have alternative means of illumination available.

WARNING When the unit is on, never disconnect the fiber optic bundle from the light source or the accessory from the end of the fiber bundle. High intensity light from the end of the fiber optic bundle can ignite combustible material.

Directions for Use Chapter 1 Introduction 7

WARNING PROVIDE ADEQUATE VENT ILATION TO PREVENT OVERHEATING. Do not cover or drape this light source. Provide a 3 inc h (7.62 cm) distance between the Welch Allyn Light Source and any solid objects.

WARNING Use only non-electrically condu ct i ve fiber bundles. Use of conductive fiber bundles will compromise the safety and effectiveness of this device.

WARNING RISK OF SHOCK. Do not operate the Light Source without a lamp installed. Disconnect power before attempting to change the lamp.

W ARNING This product comes with a power cord that is intended for use only with this product. The power cord has not been tested and approved for use with other products that may have the same power connectors. If you cannot locate the original po w er cord, please contact Welch Allyn to obtain replacement parts.

8 Chapter 1 Introduction Welch Allyn Light Source

Cautions

A caution statement in this manual identifies a condition or practice which, if not corrected or discontinued immediately, could lead to equipment failure, equipment damage, or data loss.

Caution United States federal law restricts this device to sale by or on the order of a health care practitioner.

Caution Allow the lamp to cool before replacing. Caution Since the So

lamp, always have a spare lamp available for replacement. USE CAUTION BECAUSE LAMP MAY BE HOT. Allow lamp to cool before replacing.

Caution Do not sterilize the Welch Allyn Light Source. Refer to Cleaning section for cleaning instructions.

Caution Do not switch the Welch Allyn Light Source ON and OFF in rapid succession. Doing so will dramatically shorten lamp life. Allow lamp to cool down 10 to 15 seconds between uses.

Caution Do not use or store liquids above or on the Welch Allyn Light Source.

Caution Do not operate device without the cover in place. Operate in the horizontal orientation only.

Caution Only qualified medical personnel should operate the Light Source.

Caution System integr ator is responsible for all safety testing, including optical and thermal testing.

larc Light Source uses a custom

Directions for Use Chapter 1 Introduction 9

Caution It is recommended to test dental composites with and without the optional filter prior to use with a patient.

Caution Any changes or modifications made to this device that are not expressly approved by Welch Allyn, Inc. will void the warranty and may compromise product safety.

10 Chapter 1 Introduction Welch Allyn Light Source

Note

System Description and Operation

The Welch Allyn Solarc Light Source is used to supply high quality, white light for video and optical illumination systems.

1. Verify the power switch is in the OFF position ( ). Place the light source on a smooth, hard, level surface with at least 3” air clearance between the light source and any solid objects. Plug the power supply outlet connector to the light source power input (see Figure 1) and then plug the power supply into an appropriately rated power outlet (refer to Section 4, Electrical Specifications).

2. Turn the light intensity control knob to the minimum position (see Figure 1). Plug the fiber optic bundle into the light port and connect the distal end to the instrument.

For proper lamp performance, verify the fiber optic bundle is plugged in at all times.

3. Turn the power switch to the ON position ( ).The lamp will take 10 - 15 seconds to complete the wa rm-up cycle.

4. Set the light intensity knob to the desired level (see

Figure 1).

5. Turn the unit OFF when not in use.

12 Chapter 2 System Description and Operation Welch Allyn Light Source

Note

Caution Do not restart the Solarc Light Source immediately after shutting it of f - it may fail to light. Ifthis occurs, turn the power off and wait 10 to 15 seconds before turning the unit back on.

In dental applications, the optional filter blocks light wavelengths that cure some dental composites. For white light, switch the filter out of the light path. When work ing with dental composites, switch the filter into the light path (Figure 1).

It is recommended to test dental composites with and without the optional filter prior to use with a patient.

Figure 1. Front and Rear View

Filter In

Maximum

(Optional)

Light Control

Minimum

Power Switch

Filter Out (Optional)

Power Input

Fan

Maintenance

This section provides information to replace a lamp and to clean the Light Source. There are no other serviceable parts within the Light Source.

Lamp Replacement

WARNING RISK OF SHOCK. Do not operate the Light Source without a lamp installed. Disconnect power before attempting to change lamp.

Caution LAMP MAY BE HOT. Allow lamp to cool before handling.

Recommended lamp cooling time is a minimum of 10 minutes.

Caution Do not operate device without the cover in place. Operate in the horizontal position only.

To replace the lamp:

1. Turn the So cord from both the wall outlet and the rear of the unit.

larc Light Source off and unplug the power

14 Chapter 3 Maintenance Welch Allyn Light Source

2. Remove the five screws from the Solarc Light Source using a #2 philips head screwdriver. Pivot the cover to expose the lamp.

Figure 2. Moving the Top Cover

Pivot

Removable Screws (two on opposite side)

3. Flip up the retaining latch. Pull the lamp base back and up against the retaining spring to remove th e lamp.

4. Remove t he lamp, with harness at tac hed and then disconnect the lamp connector.

Figure 3. Inside the Light Source

Retaining Latch

Retaining Spring

Lamp Base

Lamp Connector

5. Replace with Welch Allyn replacement lamp 09500-U only. DO NOT touch the lamp or the interior reflective surface of the lamp. Skin oils on the lamp will cause premature lamp failure. Only hold the outside of the refl ector or the base of the lamp. Remove any grease or fingerprints with a clean

Directions for Use Chapter 3 Maintenance 15

Q-tip moistened with alcohol. Do not leave any lint on the lamp.

6. Connect the new lamp to the connector and inse rt lamp to properly seat the alignment pin located on the bottom of the lamp into the slot located on the lamp bracket.

Figure 4. Bottom View of the Lamp Slot

Lamp Slot.

7. Close the retaining latch and replace the cover. Secure the five screws on the So supply.

Do not operate the device with out the co ver in place. Dispose of the lamp according to local, state, and federal laws.

larc Light Source. Reconnect t he power

Cleaning

Clean the Solarc Light Source monthly, or as required, as follows:

1. Prior to cleaning, turn power off and disconnect the power cord from both the wall outlet and the So

Caution Do not submerge the Solarc Light Source in water, cold steriliants, or in an ultrasonic cleaner.

Caution Do not use an autoclave, chemiclave, glutaraldehyde, iodophor or any other sterilization method, or damage may result.

larc Light Source.

16 Chapter 3 Maintenance Welch Allyn Light Source

2. Clean the external surfaces with a cloth dampened with mild soap and water or use the following cleaning/disinfecting solutions. Always follow the manufacturer’s recommendations.

• A quaternary ammonium disinfectant such as Cavicide

• A phenol, alcohol-based spray such as Lysol

brand

disinfectant

• Gluteraldehyde

• 70% isopropyl alcohol

• 10% mild bleach solution

• Metracide

• 10% Wescodyne

• Banicide

• Wavecide-0 1

If there are any questions, please contact Customer Service.

3. The pow er cord may be wiped clean using the same cleaning/ disinfecting solutions listed above. Wipe dry with a clean cloth. Care must be taken not to get the plug prongs wet. DO NOT IMMERSE.

4. Do not plug the unit into a wall outlet until it is thoroughly dry.

Directions for Use Chapter 3 Maintenance 17

Ordering Information

LB24MS00-004-00 Welch Allyn Light Source with ACMI Adapter

LB24MS00-004-01 Welch Allyn Light Source with ACMI Adapter

Power Supply:

North America: International:

Replacement Lamp: 09500-U

Power Cords:

Europe: Australia: UK:

and North American Power Supply

and European Power Supply

LBM-PS-00 LBM-PS-01

704904 704905 704906

18 Chapter 3 Maintenance Welch Allyn Light Source

Troubleshooting

If lamp is not

illuminating

and...

Fan Is Not Operating,

Light Source is not plugged into either the wall outlet or the power cord socket.

Power switch is not turned on. Depress the “ “side of the power

Plug the power cord into the wall outlet and power cord socket at back of unit.

switch.

Fan Is Operating,

Low Light Output

Power cord is damaged. This may cause intermittent operation.

No power is supplied to the wall outlet.

The lamp was not able to “cool down” before restarting.

The lamp has burned out. Replace with a new Welch Allyn

Lamp is not properly seated in recess.

Light intensity control knob closed.

Replace the power supply with a new Welch Allyn power supply.

Verify that the wall outlet has power by checking the circuit breaker status and by operating other equipment at that wall outlet.

Wait at least 15 seconds after turning the Light Source off before turning it back on.

lamp. Refer to the lamp replacement section.

Remove the lamp and re-install per the lamp replacement instructions. Verify that the lamp is properly seated.

Verify that the light intensity control knob is fully open.

Specifications

Electrical

Caution Use Welch Allyn power supplies:

•LBM-PS-00

•LBM-PS-01

Power Supply Input: Voltage: 100–240 V~, 50–60 Hz Power Supply Output: 12V , 3.4A Current: 1A (@ 100 V~) Light Box Input: 12V

Dimensions

5.8" (14.73 cm) (L) x 3.5" (8.89 cm) (W) x 2.8" (7.11 cm) (H)

Illumination System

Welch Allyn Solarc Lamp Lamp: 60 Volts, 24 watts

20 Chapter 4 Specifications Welch Allyn Light Source

Environment

Operating: Transport/Storage:

Temperature: 50° F (10° C) to 86° F (30° C) Humidity: 15 to 95% RH non-condensing

Temperature: -4° F (-20° C) to 120° F (49° C) Humidity: 15 to 95% RH non-condensing Atmospheric pressure: 700 hpa to 1060 hpa

Equipment Classification

Mode of Operation: Continuous Operation System Classification: Safety Class II Type BF Equipment Ingress of Water: IPXØ Not AP/APG Equipment

Patents

This product is covered by the following patents: 5,144,201; 5,083,059; 5,13 8, 22 8; 5, 117,154; 5,420,477; 5,539,273

Directions for Use Chapter 4 Specifications 21

3045357

Approvals

EN/IEC 60601-1 UL60601-1 CAN/CSA C22.2 No. 601.1-M90 IEC60601-1-2

EMC Framework of Australia

The CE mark on this product indicates it has been tested to and conforms with the provisions noted within the 93/42/EEC Medical Device Directive.

European Regulatory Manager Welch Allyn Ltd., Navan Business Park Dublin Road Navan, County Meath, Republic of Ireland. Tel.: +353 46 90 67700 Fax: +353 46 90 67755

22 Chapter 4 Specifications Welch Allyn Light Source

Emissions and Immunity Information

Electromagnetic Emissions

The Welch Allyn Light Source is intended for use in the electromagnetic environment specified below. The customer or user of the Welch Allyn Light Source should assure that it is used in such an environment.

Emissions test Compliance Electromagnetic environment - guidance

RF emissions CISPR 11

Harmonic emissions IEC 61000-3-2

Voltage fluctuations/ flicker emissions IEC 61000-3-3

Group 1 The Welch Allyn Light Source 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.

Class B The Welch Allyn Light Source is suitable for use in all

establishments including domestic and those directly

Class A

Complies

connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Electromagnetic Immunity

Immunity test IEC 60601

test level

Electrostatic discharge (ESD) IEC 61000-4-2

Electrical fast transient (EFT)/ burst IEC 61000-4-4

± 6 kV contact ± 8 kV air

±2 kV mains ±1 kV I/O

Compliance level

± 6 kV contact ± 8 kV air

±2 kV mains Not applicable

Electromagnetic environment guidance

Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.

Mains power quality should be that of a typical commercial or hospital environment.

Directions for Use Chapter 4 Specifications 23

Surge IEC 61000-4-5

Voltage dips, short interruptions, and voltage variations on power supply input lines. IEC 61000-4-11

Power frequency (50/60Hz) magnetic field IEC 61000-4-8

Immunity test

±1 kV differential ±2 kV common

>95% dip in

0.5 cycle

60% dip in 5 cycles

30% dip for 25 cycles

>95% dip in 5 seconds

3 A/m 3 A/m Power frequency magnetic fields

IEC 60601 test level

Compliance level

±1 kV differential ±2 kV common

>95% dip in

0.5 cycle

60% dip in 5cycles

30% dip for 25 cycles

>95% dip in 5 seconds

Electromagnetic Immunity

Electromagnetic environment - guidance

Portable and mobile RF communications equipment should be used no closer to any part of the Welch Allyn Light Source, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Mains power quality should be that of a typical commercial or hospital environment.

Mains power quality should be that of a typical commercial or hospital environment. If the user of the Welch Allyn Light Source requires continued operation during power mains interruptions, it is recommended that the Welch Allyn Light Source be powered from an uninterruptible power supply or battery.

should be at levels characteristic of a typical location in a typical commercial or hospital environment.

Conducted RF, IEC 61000-4-6

3 Vrms 150 kHz to 80 MHz

Recommended separation distance

3 Vrms d = (1.17)

24 Chapter 4 Specifications Welch Allyn Light Source

Radiated RF, IEC 61000-4-3

3 V/m 80 MHz to

2.5 GHz

3 V/m d = (1.17) 80 MHz to 800 MHz

d = (2.33) 800 MHz to 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, be less than the compliance level in each frequency

range.

should

Interference may occur in the vicinity of equipment marked with the following symbol:

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. 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 Welch Allyn Light Source is used exceeds the applicable RF compliance level above, the Welch Allyn Light Source should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the Welch Allyn Light Source.

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

Directions for Use Chapter 4 Specifications 25

Recommended Separation Distances Between Portable and Mobile RF Communications

Equipment and the Welch Allyn Light Source

The Welch Allyn Light Source is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or user of the Welch Allyn Light Source can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Welch Allyn Light Source as recommended below, according to the maximum output power of the communications equipment.

Rated max. output power of transmitter

(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.

Separation distance according to frequency of transmitter (m)

150 kHz to 80 MHz

d = (1.17)

P P P

80 MHz to 800 MHz

d = (1.17)

800 MHz to 2.5 GHz

d = (2.33)

26 Chapter 4 Specifications Welch Allyn Light Source

Warranty and Service

Warranty

Welc h Allyn w arrants the Welch Allyn Light Source when new, to be free of defects in material and workmanship and to perform in accordance with manufact urer’s specifications when subject to normal use and service for a period of one year from the date of purchase from W elch Allyn or an authorized agent. Welch Allyn will either repair or replace any components found to be defective or at variance from manufacturer’s specifications within this time at no cost to the customer. It shall be the purchaser’s responsibility to return the instrument directly to the authorized distributor, agent, or service representative.

This warranty does not cover the So or failure due to tampering, misuse, neglect, accidents, improper installation, modification, shipping, or to improper maintenance, service, and cleaning procedu res. This warranty is also void if the instrument is not used in accordance with manufacturer’s re commendation s or if required or serviced by other than Welch Allyn or an authorized agent. Purchase date determines warranty requirements. No other express or implied warranty is given.

larc Lamp or breakage

28 Chapter 5 Warranty and Service Welch Allyn Light Source

Service

If you have an equipment problem that you cannot resolve, you may call the Welch Allyn Service Center nearest you for assistance. Technical service support is available by telephone on normal business days at the phone numbers listed below. If you are advised to return a product to Welch Allyn for repair or routine maintenance, schedule the repair with the service center nearest you.

Before ret urning a product f or repair y ou must obtain authorization from Welch Allyn. An RMA (Return MerChandise Authorization) number will be given to you by our service personnel. Be sure to note this number on the outside of your shipping bo x. Returns without an RMA number will not be accepted.

USA Customers

Welch Allyn, Inc., U.S.A. Tel: 1-315-685-4347 Fax: 315-685-2854

Welch Allyn, GmbH & Co KG

Tel: 00-49-7477-927173 Fax: 00-49-7477-927293

Welch Allyn France SARL

Tel: (011) 33 1.6009.3366 Fax: (011) 33 1.6009.6797

Welch Allyn, Ltd., Australia

Tel: 011-61-294-183-155 Fax: 011-61-294-183-650

Welch Allyn UK Ltd

Tel: 0207-365-6780 Fax: 0207-365-9694

Canada Customers

Welch Allyn, Ltd., Canada Tel: 905-890-0004 Fax: 905-890-0008

Welch Allyn, Ltd., Singapore

Tel: 011-656-291-0882 Fax: 011-656-291-5780

Welch Allyn, China

Tel: 011-86-21-63279631 Fax: 011-86-21-63279632

Welch Allyn, Japan

Tel: 011-813-5212-7391 Fax: 011-813-3261-7372

Latin American Customers

MD International Tel: 1-305-669-9003 Fax: 1-305-669-1971

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