Welch Allyn 88001A Istruzioni per l'uso

Video Colposcope

Colposcope vidéo/Videocolposcopio

Videokolposkop/Videocolposcopio

Videokolposkop/Videocolposcoop

Colposcópio Vídeo/Videokolposkop

REF 88000A/88001A/89000A/88007/89001A/88007/88002A/88004A/88006A/89006

Directions for Use ....................................................................... 1

Mode d’emploi ........................................................................... 45

Instrucciones de uso ................................................................ 89

Gebrauchsanleitung ............................................................... 133

Istruzioni per l’uso ................................................................... 177

Bruksanvisning ........................................................................ 221

Gebruikshandleiding ............................................................... 265

Instruções de utilização ......................................................... 309

Brugsanvisning ........................................................................ 353

Video Colposcope

Directions for Use

REF 88000A/88001A/89000A/88007/89001A/88007/88002A/88004A/88006A/89006A

2 Welch Allyn Video Colposcope

form, this manual or any part thereof without permission from Welch Allyn.

Welch Allyn assumes no responsibility for any injury to anyone, 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 statement of intended use published in this manual.

Welch Allyn

®

is a registered trademark of Welch Allyn.

For information about any Welch Allyn product, call Welch Allyn Technical Support:

Manual Part Number 880332 Ver. C

Welch Allyn

4341 State Street Road

Skaneateles Falls, NY 13153 USA

www.welchallyn.com

Printed in USA

USA +1 800 535 6663

+1 315 685 4560

Australia +61 2 9638 3000

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Latin America +1 305 669 9003 Netherlands +31 157 505 000

Singapore +65 6419 8100 South Africa +27 11 777 7555

United Kingdom +44 207 365 6780 Sweden +46 85 853 6551

3

Contents

1 - Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Indications For Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Warnings and Cautions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

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

Cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

2 - Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Video Colposcope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Front View. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

Side Views . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

Back View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

Bottom View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

Vertical Stand . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

Swing Arm Stand . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

Printer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

3 - Connections and Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

Connecting Video Colposcope with Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

Connecting Video Colposcope with Optional VCR/Video Printer . . . . . . . . . . . . 18

Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

General Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

Video Colposcope. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

Vertical Stand Assembly. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

Swing Arm Stand Assembly. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

Setting Up Video Colposcope. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

4 - Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

Power Switch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

Lamp Ignition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

Focus and Zoom Controls. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

Mag Index Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

Green Filter Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

Polarization Filter Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

Illumination Beam Director . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

Vertical Height Adjustment Ring (Vertical Colposcope Model Only). . . . . . . . . . 25

Swing Arm Height Adjustment (Swing Arm Colposcope Model Only). . . . . . . . 25

Positioning Video Colposcope. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

4 Contents Welch Allyn Video Colposcope

Remote Video Functions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

5 - Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

Disinfecting Solutions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

Video Colposcope Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

Lens Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

Camera Lens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

Illumination Beam Director Lens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28

Replacing Lamp . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28

Replacing Fuses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

6 - Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

Video Colposcope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

Video Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

Agency Approvals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

Guidance and Manufacturer’s Declaration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36

Emissions and Immunity Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36

7 - Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41

Technical Assistance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41

Service Manual/Spare Parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41

Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43

1

5

Introduction

Thank you for purchasing the Welch Allyn Video Colposcope. Follow the operation and

maintenance instructions found in this manual and your Video Colposcope will provide

you with many years of reliable service. Please read these instructions thoroughly before

attempting to use your new Video Colposcope.

IMPORTANT: The material outlined in this manual should be reviewed and understood

prior to operation of the equipment.

Indications For Use

For examination of the tissues of the vagina, cervix, and external genitalia, to investigate,

by means of magnification, abnormal cervical cytology or suspicious lesions of the lower

female genital tract. Also used for corresponding biopsy and treatment, when indicated.

Symbols

On: Power: Connects to

the low voltage supply.

Off: Power: Disconnects

from the low voltage supply.

Attention: Consult user’s

manual for additional

information.

Warning: 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.

High temperatures Caution: 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.

Risk of fire. Replace fuses

as marked.

High-intensity light

Power supply of unit is

energized whenever power

cord is plugged in.

Type B Equipment

6 Introduction Welch Allyn Video Colposcope

Warnings and Cautions

Familiarize all operating personnel with the general safety information in this summary.

Specific warnings and cautions are also found throughout this manual.

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 Users of this equipment should be thoroughly trained in the

appropriate medical procedures. Furthermore, they should take the time to

read and understand these instructions before performing any procedure. They

should also read and understand the instructions for any other equipment used in

conjunction with the Video Colposcope (i.e. electrosurgical generators). Failure to

do so may result in injury to the patient and/or damage to the Video Colposcope.

WARNING The Video Colposcope should not be operated in the presence of

flammable or explosive gases (i.e., anesthetics) or chemicals, or installed in areas

where these materials are commonly used.

WARNING Keep all liquids away from electrical equipment to avoid the

possibility of shock and instrument damage.

WARNING The lamp is extremely bright. DO NOT stare directly into illumination

lens when the lamp is lit.

WARNING Video Colposcope user should adhere to the operating conditions

found in this manual. Otherwise, instrument damage may occur and/or operator/

patient safety may be compromised.

WARNING All signal input and output (I/O) connectors are intended for

connection to only peripheral devices (example: monitor, video printer, VCR, PC,

DV Converter) that are in compliance with IEC 60601-1 (General Requirements

for Safety, Medical Electrical Equipment) or other IEC standards (for example

IEC 60950, Information Technology Equipment – Safety) as appropriate to the

nature of the peripheral device. Connecting additional peripherals to the Video

Colposcope may increase the risk associated with chassis or patient leakage

currents. To maintain operator and patient safety, the User should consider

the system leakage current requirements of IEC 60601-1-1 (Medical Electrical

Equipment, Safety Requirements for Medical Electrical Systems). The user

should measure leakage currents accordingly to confirm that no electric shock

hazard exists. An isolation transformer that is in compliance with IEC 60601-1

used to power the additional peripherals may be used to control the system

leakage current to comply with the requirements of IEC 60601-1-1.

WARNING If peripheral devices (example: monitor, video printer, VCR ,other)

do not comply with IEC 60601-1-1 (Medical Electrical Equipment, Safety

Requirements for Medical Electrical systems), they must be kept out of the

patient area (6 feet minimum from patient).

WARNING DO NOT use a converter adapter that will convert the three-prong

AC plug to a two-prong line plug. The power supply in the Video Colposcope will

not be properly grounded and electric shock might result.

Directions for Use Introduction 7

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.

WARNING For safety, the Video Colposcope should only be coupled to a

grounded 110–120 VAC hospital-grade outlet (220–240 volt, 50 cycle

international).

WARNING The lamp operates at a high temperature. DO NOT attempt to

remove the lamp before allowing it to cool. Allow at least five minutes for the

lamp to cool before replacing. Replace with Welch Allyn lamp #09800-U only.

Caution Federal law restricts sale of this device to, or to the order of, a

physician or other appropriately licensed medical professional.

Caution Occasionally inspect the power cord for signs of cuts, abrasions or

dents.

Caution The Video Colposcope should never be stored or operated in areas

where it could get wet or could be exposed to any environmental conditions like

extreme temperature or humidity, direct sunlight, dust, etc.

Caution All service to the Video Colposcope must be performed by Welch Allyn

or by an authorized repair center.

Caution There are no user servicable parts (other than the lamp and fuses) in

this unit or in its accessories. Any attempt to disassemble and/or repair this unit

will result in voiding of the warranty.

Caution The Video Colposcope is cooled via a fan located in the back of the

unit. The fan draws air in from beneath the Video Colposcope and exhausts the

air out the back of the Video Colposcope. To avoid overheating, verify that the

unit is no less than 6" from a wall.

Caution Do not clean illumination lens with alcohol. Do not touch optical or

illumination lenses except as described in Maintenance section of this manual.

Caution The colposcope can be damaged if the unit is transported while

holding the handle. The unit should be transported by grasping the pole.

Caution Do not sterilize.

Caution Do not spray or allow solution to drip into the air vents.

Caution Do not immerse any part of the unit in cleaning solutions.

8 Introduction Welch Allyn Video Colposcope

2

9

Components

Video Colposcope

88000A

89000A

Video Colposcope and vertical stand

with vertical stand hardware kit:

• Allen wrench

• Allen bolt

• Mounting washer

• Spacer

Video Colposcope and swing arm

stand with swing arm hardware kit:

• Allen wrench

•Bolt

10 Components Welch Allyn Video Colposcope

All illustrations are for reference only.

88600

S-Video Cable

761076-0

Power Cord

Optional Accessories

09800-U

Replacement Lamp

88500

RS-232 Interface Cable

488307-9

Replacement Fuse (2 required)

88010

Cervical Model

88040

Dust Cover for Vertical Stand

89040

Dust Cover for Swing Arm

Directions for Use Components 11

Front View

Illumination Beam Director.

Directs lamp beam.

Camera Lens. The lens that

establishes the magnification

and field of view.

Illumination Beam

Director Lens. Provides

light for the examination.

88030

Vertical Stand with Base Only

89030

Swing Arm Stand with Base Only

Monitor. For specifications see “Video Monitor” on

page 34. Contact Welch Allyn for details.

VCR/Printer. Contact Welch Allyn for details.

Image Capture System. Contact Welch Allyn for details.

Note

Only accessories and components indicated in this manual are to be used with

the Welch Allyn Video Colposcope system.

12 Components Welch Allyn Video Colposcope

Side Views

FINE

MAG

INDEX

Zoom control button.

Pressing + or - increases or

decreases magnification

accordingly.

Ventilation slots.

Allow air to enter and

leave unit, cooling

internal components.

Green filter LED indicator.

Illuminates if the electronic

green filter is on.

Ventilation slots. Allow air

to enter and leave unit,

cooling internal components.

Green filter button.

Pressing turns the electronic

green filter on or off.

Fine Focus

control button.

Pressing < or >

adjusts the focus.

Zoom control button.

Pressing + or - increases or

decreases magnification

accordingly.

Fine Focus control

button. Pressing < or >

adjusts the focus.

Polarization filter

control. Adjusts the

proportion of glare

removed from the image.

Mag button. Displays

magnification index on

screen.

Mag LED indicator.

Illuminates if Mag Index is on.

Directions for Use Components 13

Back View

F

C

V

Attachment knob. Fastens

handle to Video Colposcope.

Video Colposcope handle. For

positioning the colposcope in the

proper up/down, left/right position.

Remote video function buttons.

Allows use of remote printing and

saving functions with appropriate

accessory device.

Ventilation slots. Allow air

to enter and leave unit,

cooling internal components.

Power switch. Power control

for the Video Colposcope.

Bottom View

Lamp access door. Removes for lamp

replacement. (Note: If door is not properly

closed, interlock power switches will not

activate and the lamp will not start.)

Mounting piece. Allows the Video Colposcope to attach to the stand.

On the swing arm model, the mounting piece is located at the top of

the colposcope. On the vertical stand model, the mounting piece is

located at the bottom of the colposcope.

Ventilation slots.

Allow air to enter and

leave unit, cooling

internal components.

14 Components Welch Allyn Video Colposcope

Vertical Stand

Vertical rolling base stand.

Allows mobility with 5-caster

base, including two locking

casters.

Fuse drawer. Opens for

replacement of fuses.

Power supply cord

receptacle. Couples with

power cord, which should be

plugged into a 110–120 VAC

hospital-grade outlet

(220–240 volt, 50 cycle

S-Video output.

Outputs S-Video.

RS232 interface cable

connector. Couples with

RS-232 interface cable.

Height adjustment ring.

Allows vertical movement

and locking of stand at desired

height;vertical height adjustment

36"–46" (91.4 cm to 116.8 cm).

Swing Arm Stand

Swing arm rolling base

stand. Allows overhead

positioning of the instrument

with 5-caster weighted base,

including two locking casters;

vertical height 29.5" to 49.5"

(74.9 cm to 125.7 cm).

Height adjustment knob.

Allows adjustment of arm

tension and vertical height

adjustment 26.5" to 45.5"

(67.3 cm to 115.6 cm).

Directions for Use Components 15

Monitor

LINE A

PARALLEL REMOTE

RGB/COMPONENT

LINE B

~AC IN

IN

OUT

VIDEO

S-VIDEO

G/Y

B/Pb

R/Pr

VIDEO

AUDIO

AC IN

socket

LINE A [S-Video composite

(BNC), (4 pin mini-DIN),

Audio (RCA pin)]

LINE B [composite

(BNC), Audio (RCA pin)]

PARALLEL REMOTE

(modular connector)

RGB/COMPONENT

(BNC), Aduio (RCA pin)

WARNING If peripheral devices (example: monitor, video printer, VCR ,other) do

not comply with IEC 60601-1-1, they must be kept out of the patient area (6 feet

minimum from patient).

WARNING All signal input and output (I/O) connectors are intended for

connection to only peripheral devices (example: monitor, video printer, VCR)

that are in compliance with IEC 60601-1 (General Requirements for Safety,

Medical Electrical Equipment) or other IEC standards (for example IEC 60950,

Information Technology Equipment – Safety) as appropriate to the nature of the

peripheral device. Connecting additional peripherals to the Video Colposcope

may increase the risk associated with chassis or patient leakage currents.

To maintain operator and patient safety, the User should consider the system

leakage current requirements of IEC 60601-1-1 (Medical Electrical Equipment,

Safety Requirements for Medical Electrical Systems). The user should measure

leakage currents accordingly to confirm that no electric shock hazard exists.

An isolation transformer that is in compliance with IEC 60601-1 used to power

the additional peripherals may be used to control the system leakage current

to comply with the requirements of IEC 60601-1-1.

Note

Image is for reference only. Actual monitor may vary. Monitor shown is

SONY LMD-1410.

Use the video monitor provided by Welch Allyn or any video monitor that meets

the specifications listed on page 34.

For detailed instructions, please refer to the provided manufacturer’s operation

manual.

16 Components Welch Allyn Video Colposcope

Printer

NTSC

PA L

REMOTE

12

~ AC IN

RS-2232C

INPUT

OUTPUT

S-VIDEO

VIDEO

Input Connectors. To connect the video equipment supplying the

source image.

Connector Connectable Equipment

S-VIDEO Equipment with a S-Video (Y/C) output

connector

VIDEO Equipment with a composite video signal

output connector

Output Connectors. To connect the video monitor. Refer to “Important

safeguards/notices for use in the medical environments.”

Connector Connectable Equipment

S-VIDEO Video Monitor with a S-Video (Y/C)

separated input connector

VIDEO Video Monitor with a composite video signal

input connector

~ AC IN. To connect the

printer to a wall outlet

with the supplied cord.

Equipotential Ground

Terminal Connector.

To connect to the

equipotential plug to bring

the various parts of a system

to the same potential.

RS-232C Connector. To connect the

Video Colposcope to control the printer.

NTSC/PAL (TV) Selector. Set this selector according to the TV system of the

input signal. If you change this setting, turn the printer power off and then back

on again.

Selector position When

NTSC NTSC system video equipment is connected.

PAL PAL system video equipment is connected.

Remote 1 Connector. To connect an RM-5500

Remote Control Unit (not supplied) to be used as

a wired remote control unit.

Remote 2 Connector. To connect an RM-91

Remove Control Unit (not supplied).

WARNING If peripheral devices (example: monitor, video printer, VCR ,other) do

not comply with IEC 60601-1-1, they must be kept out of the patient area (6 feet

minimum from patient).

Note

For detailed instructions, please refer to the printer operation manual that has

been provided by the manufacturer. Printer shown is SONY UP-20; this is for

reference only.

3

17

Connections and Assembly

Connecting Video Colposcope with Monitor

LINE A

PARALLEL REMOTE

RGB/COMPONENT

LINE B

~AC IN

IN

OUT

VIDEO

S-VIDEO

G/Y

B/Pb

R/Pr

VIDEO

AUDIO

S-Video Cable to Monitor

Line A S-Video (Y/C) In

Back Panel of Monitor