Welch Allyn 6V User Manual [en, de, es, fr, it]

Rectal Light Handle

REF 73211

6V Power Supply

REF 73305, 73322, 73324, 73326

English . . . . . . . . . . . . . . . . . . . 1-1

Français . . . . . . . . . . . . . . . . . . 2-1

Espanõl. . . . . . . . . . . . . . . . . . 3-1

Português. . . . . . . . . . . . . . . . . 4-1

Italiano . . . . . . . . . . . . . . . . . . . 5-1

Deutsch . . . . . . . . . . . . . . . . . . 6-1

Dansk . . . . . . . . . . . . . . . . . . . . 7-1

Nederlands . . . . . . . . . . . . . . . . 8-1

Svensk . . . . . . . . . . . . . . . . . . . 9-1

Norsk . . . . . . . . . . . . . . . . . . . 10-1

Copyright 2009, Welch Allyn, Inc. All rights are reserved. No one is permitted to reproduce or duplicate, in
any form, this manual or any part thereof without permission of 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. Welch Allyn is protected under various patents

and patents pending.
Printed in USA

Table of Contents

Symbol Descriptions . . . . . . . . . . . . . . . . . . . . . .1-1

Warnings and Cautions . . . . . . . . . . . . . . . . . . . .1-1

Instructions for Use . . . . . . . . . . . . . . . . . . . . . . .1-3

REF 73305, 73322, 73324, 73326

(Power Supplies) . . . . . . . . . . . . . . . . . . . . .1-3

REF 73211 Rectal Light Handle . . . . . . . . . . . . . . .1-4

Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-7

Preventative Maintenance . . . . . . . . . . . . . . . . . . .1-7

Lamp Replacement . . . . . . . . . . . . . . . . . . . . . . . .1-7

Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-8

Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-10

Specifications . . . . . . . . . . . . . . . . . . . . . . . . . .1-11

Approvals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-12

Guidance and Manufacturer’s Declaration . . . . . .1-13

Trouble Shooting Guide . . . . . . . . . . . . . . . . . . .1-17

Troubleshooting Guide - Qualified Personnel

Only . . . . . . . . . . . . . . . . . . . . . . . . .1-18

Warranty and Service . . . . . . . . . . . . . . . . . . . .1-19

Limited Warranty . . . . . . . . . . . . . . . . . . . . . . . . .1-19

Technical Assistance . . . . . . . . . . . . . . . . . . . . . . 1-19

Welch Allyn Service Centers . . . . . . . . . . . . . . . .1-21

Thank you for purchasing the Welch Allyn REF 73211 Rectal Light Handle
and/or the REF 73305, 73322, 73324, 73326 power supply. Please review
this manual prior to using this system.

Only properly trained physicians for endoscopic type examinations should
use the 73211 Rectal Light Handle and its appropriate Power Supply when
coupled with the Welch Allyn devices listed in the table on page 1-6.

The 73211 Rectal Light Handle is designed for connection only with the
power source and appropriate country voltage and outlet style listed
within this manual. No other use of these products is intended or
advised. Please follow the guidelines set forth in this manual for proper
connection and use of the Rectal Light Handle.

Classification

Class II, Type BF Applied Part, Ordinary Equipment

Intermittent Operation

Symbol Descriptions

Attention, Warning, Caution:
See instructions for use.

Caution, high temperatures - - - Direct Current

Caution, high-intensity light Alternating Current

Double Insulation IPXØ

Warnings and Cautions

WARNING: To avoid eye injury, do not look directly into the light beam.

WARNING: Lamp is harmful to skin if touched when hot. Allow lamp to
cool a minimum of 5 minutes before replacing.

1-1

Type BF Applied Part

Not protected from the
ingress of water.

WARNING: Rectal Light Handle and/or Power Supply is not suitable for
use in the presence of a flammable anesthetic mixture with air or
oxygen or nitrous oxide. An explosion may result.

WARNING: Lamp generates heat and should remain off until just prior
to and immediately after use. Do not place Rectal Light Handle onto a
flammable surface if lamp is illuminated or hot.

WARNING: Disconnect power supply from outlet prior to any
maintenance.

WARNING: Only use the 6V power supplies described within this
manual with the 73211 Rectal Light Handle. Failure to observe this
warning may cause damage to the power supply and/or non-approved
device

WARNING: The use of accessories, transducers, and/or cables other
than those specified, with the exception of those sold by the
manufacturer as replacement parts for internal components, may result
in increased emissions or decreased immunity of the equipment or
system.

CAUTION: U.S. Federal Law restricts this device to sale by or on the
order of a physician.

CAUTION: Rectal Light Handle Illumination is intense.
CAUTION: This endoscopic accessory is for use with the Welch Allyn

devices listed in the table on page 1-6 only. Do not use the illuminator
for any other use.

CAUTION: Use only the cleaning methods described in this manual.
CAUTION: There are no user-serviceable parts inside the device except

the lamp. Contact the authorized Service Center listed on page 1-21 for
service related issues.

CAUTION: The 73211 Rectal Light Handle is designed for connection
only with the power source and appropriate country voltage and outlet
style listed within this manual. No other use of these products is
intended or advised.

CAUTION: Medical Electrical Equipment needs special precautions
regarding EMC and needs to be installed and put into service according
to the EMC information starting on page 1-13.

CAUTION: Portable and Mobile RF Communications Equipment can
affect Medical Electrical Equipment.

Instructions for Use

ABC D

USA

NEMA 1-15P

EUROPE

CEE 7/16

UK

BS 1363

AUSTRALIA /
NEW ZEALAND

AS 3112

The Rectal Light Handle’s power supply (REF 73305, 73322, 73324, 73326)
provides power from an appropriate wall outlet to the Rectal Light Handle
(REF 73211) which houses the lamp (REF 07800). The Rectal Light Handle and its
appropriate power supply provide an illumination system that is intended for use
with Welch Allyn devices and/or accessories (see table on page 1-6).

REF 73305, 73322, 73324, 73326 (Power Supplies)

Verify that the power supply will connect to the appropriate outlet and that the
power supplied to the outlet is within the range specified in the table provided.

REF

73305 120V 60 Hz 71 110 - 130
73322 230V 50 Hz 30 210 - 230
73324 240V 50 Hz 27 230 - 250
73326 234V 50 Hz 27 230 - 250

Nom. Input

Vol ta ge

Input Current

at Nom. Input

Volta ge (mA)

Input Voltage

Range (V.)

Outlet Type

Insert the Power Supply into the receptacle of
an appropriate voltage and plug configuration.

Once properly connected, the green LED
located on the power supply housing will
illuminate indicating power is present to the
power supply cord.

Plug Style

A

B

C

D

1-3

REF 73211 Rectal Light Handle

REF 73305 (SHOWN)
REF 73322
REF 73324
REF 73326

REF 73211

REF 38700

REF 36019

REF 38/39 Series

REF 37 Series

REF 53110

REF 32 Series

REF 53130

Attach the 73211 Rectal Light Handle to the appropriate device selected
from the table on page 1-6.

1-4

To assemble/disassemble the Rectal Light Handle System:

Input Port

73211

1. Select the appropriate device from the table on page 1-6.

2. Insert the 73211 Rectal Light Handle over the devices rectangular “input
port” while twisting the 73211’s knob in the “release” direction as shown.
Release the knob and verify that the 73211 Rectal Light Handle is securely
attached to the device.

3. Plug the REF 73305, 73322, 73324, or 73326 Power Supply into an
appropriate outlet.

4. Align the plug at the end of the Rectal Light Handle cord to the connector at
the end of the Power Supply and connect. The lamp in the 73211 will turn on
immediately.

5. To turn the lamp off, disconnect the Rectal Light Handle from the Power
Supply.

6. To remove the device the from the Rectal Light Handle, twist the 73211’s
knob in the “release” direction and pull the 73211 off of the device’s input
port.

1-5

The Rectal Light Handle (REF 73211) and power supply (REF 73305,
73322, 73324, 73326) are designed to work with the following Welch
Allyn devices for endoscopic procedures:

Welch Allyn 73211 Rectal Handle

32 Series 38/39 Series Fitted with 38700

32010 11mm x 10cm Pediatric FO Sig 38108 8 mm x 89mm Std Ano Spec

32020 11mm x 25cm Stricture FO Sig 38114 14mm x 89mm Std Ano Spec

32410 15mm x 15cmPediatric FO Sig 38119 19mm x 89mm Std Ano Spec

32420 15mm x 25cm FO Sig 38122 22mm x 89mm Std Ano Spec

32810 19mm x 15cm Std FO Sig 38900 20mm x 68mm Rotating Ano Spec

32820 19mm x 25cm Std FO Sig 38614 14mm x 89mm Operating Ano Spec

33830 19mm x 30cm Std FO Sig 38619 19mm x 89mm Operating Ano Spec

32830 10mm x 35cm Std FO Sig 38622 22mm x 89mm Operating Ano Spec

33220 23mm x 25cm Std FO Sig 39614 14mm x 127mm Long Ano Spec

33620 27mm x 25cm Std FO Sig 39619 19mm x 127mm Long ano Spec

37 Series

37019 19mm x 7cm FO Anoscope

37023 23mm x 7cm FO Anoscope 53130 19mm x 25cm KleenSpec Disp Sig

37027 27mm x 7cm FO Anoscope 53110 Disposable Anoscope

39622 22mm x 127mm Long Ano Spec

Disposables Fitted with 36019

1-6

Maintenance

CW

CCW

O-ring

Lamp REF 07800

Rectal Light Handle Sleeve

Preventative Maintenance

Examine cords, connections, and transformer case for wear or damage
monthly.

After every use, clean the Rectal Light Handle according to the Cleaning
Section of this manual.

Lamp Replacement

NOTE: The lamp is the only user-serviceable part on the Rectal Light
Handle (REF 73211). Refer to the above figure as a visual aid to replace
the lamp.

1. Disconnect the system power supply from the wall outlet and then
disconnect the Rectal Light Handle from the power supply cord. Allow lamp
to cool for a minimum of 5 minutes.

2. Unscrew the Rectal Light Handle outer sleeve counter clockwise (CCW) to
expose the lamp as shown.

3. Unscrew the lamp CCW from the Rectal Light Handle body.

4. Inspect the lamp socket of the Rectal Light Handle for damage or
irregularities. Contact the authorized Service Center listed on page 1-21 if any
irregularities are found.

5. Using a new Welch Allyn lamp, verify the lamp number is REF 07800 and that
the o-ring is present and in good condition.

6. Screw the lamp clockwise (CW) into the Rectal Light Handle body and
tighten sufficiently to compress the lamp o-ring.

7. Screw the Rectal Light Handle sleeve CW onto the Rectal Light Handle body
and tighten sufficiently to secure to the handle.

1-7

8. Connect the power supply to the appropriate wall outlet and reconnect the
Rectal Light Handle cord to the power supply cord and verify that the lamp is
illuminated.

9. If the lamp fails to illuminate, refer to the Troubleshooting section on page 1­17 or contact your local Service Center (page 1-21) for further assistance.

Cleaning

Part Numbers 73210 and 73211

(including 07800-U lamp)

Part Number 73500

(including 03100-U lamp)

WARNING Allow the lamp to cool for at least 5 minutes before
handling.

NOTE Leave the lamp installed while reprocessing 73210, 73211 and

73500.

Assembly and Disassembly Instructions for 73210 and 73211

1. Disconnect the light handle from the power supply cord and the
device.

2. Unscrew the outer sleeve of the handle by turning it
counterclockwise.

1-8

3. Follow one of the reprocessing methods described below.

CW

CCW

Rectal Light Handle Outer
Sleeve

Rectal Light Handle Body and
Cord

4. After performing a reprocessing procedure, wipe the lamp with a soft, dry,
lint free cloth.

5. Re-attach the clean sleeve to the handle by screwing in a clockwise direction.

6. Re-connect the power supply cord to the light handle and verify that the unit
works by plugging it in. If the lamp fails to illuminate follow the
troubleshooting instructions located in light handle manual ( 700791)
supplied with your handle.

Cleaning (73210, 73211 and 73500)

1. Prepare an enzymatic detergent formulated for endoscopic instru­ments according to the manufacturer’s instructions.These instruc­tions were validated using ENZOL/CIDEZYME.

2. Submerge the item in the cleaning solution.

3. Using a soft bristle brush, scrub the item submerged in the cleaning solution
for a minimum of 5 minutes then rinse with sterile water for 5 minutes.

Intermediate Level Disinfection (73210, 73211 and 73500)

1. Follow the Cleaning instructions above.

2. Using CaviWipes™, wipe all item surfaces and keep wet with CaviWipe
solution for a minimum of 5 minutes.

3. Allow the item surface to dry for a minimum of 10 minutes.

Sterilization (73211 ONLY)

Caution Autoclaving the light handle may reduce the product’s
functional life.

1-9

1. Follow the Cleaning instructions above.

2. Perform one autoclave cycle that includes 6 minutes at 270° F (132° C) and a
cool down period of at least 15 minutes. These instructions were validated
using a gravity autoclave. Validate any other sterilization equipment and load
configurations.

Disposal

There are no harmful materials associated with the Rectal Light Handle
System.

There are no risks associated with the disposal of this device after its
useful life if it is cleaned per the instructions in this manual.

1-10

Specifications

Classification: Class II, Type BF Applied Part

Input: 100 to 240V , 50/60 Hz, 200 mA

Output: 6.0V , 1150 mA

Category: Not AP/APG Equipment

Physical Specifications:

Rectal Light Handle: 96mm (3.775") x 25mm (1.00"), 104 grams (3.67 oz)
Power Supply: 43mm (1.71") L x 52mm (2.06") W x 55mm (2.18") H
Power Supply Cord: 183 cm (71.4")

Illumination:

Lamp Life: 75 hours
Lamp Voltage: 6 V
Lamp: Welch Allyn REF 07800

IPX Rating: IPXØ

Environment

Operating: +10° C to +35° C (50° F to 95° F), 95% RH

500 hPa to 1060 hPa

Transport/Storage: -20° C to +49° C (-2° F to 120° F), 95% RH,

500 hPa to 1060 hPa

Intermittent Operation
Rectal Light Handle 10 minutes on max; 5 minutes off min

1-11

Approvals

74227

US

74227

L

I

S

T

E

D

L

I

S

T

E

D

C

CM

I

N

T

E

R

T

E

K

EC REP

N344

CERTIFIED TO: CAN/CSA STD C22.2 NO. 601.1

CONFORMS TO: EN/IEC 60601-1, UL 60601-1,
EN/IEC 60601-1-2, EN/IEC 60601-2-18

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

European Regulatory Manager

European Regulatory Manager
Welch Allyn Ltd.
Navan Business Park
Dublin Road
Navan, County Meath, Republic of Ireland
Tel.: [phone] • Fax: [phone]

Australia AS/NZS 3200.1

1-12

Guidance and Manufacturer’s Declaration

The REF 73211 and its powering accessories is intended for use in the electromagnetic environment specified

below. The customer or user of the REF 73211 and its powering accessories should assure that it is used in

such an environment.

Emissions Test Compliance Electromagnetic Environment - Guidance

Emissions for all EQUIPMENT and SYSTEMS

RF Emissions
CISPR 11

RF Emissions
CISPR 11

Harmonics
IEC 61000-3-2

Flicker
IEC 31000-3-3

Group 1 The REF 73211 and its powering accessories uses RF

Class B The REF 73211 and its powering accessories is suitable for

Class A

Complies

energy for its internal function. Therefore, its RF emissions
are very low and are not likely to cause interference in
nearby electronic equipment.

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.

1-13

The REF 73211 is intended for use in the electromagnetic environment specified below. The customer or user

of the REF 73211 should assure that it is used in such an environment.

Electromagnetic Immunity for all EQUIPMENT and SYSTEMS

Immunity Test IEC 60601

Test Level

ESD
IEC 61000-4-2

EFT
IEC 61000-4-4

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

Note 1: The REF 73211 and its power accessories are a simple power supply and a lamp. The only EMC test
events that could affect the performance or environment of the system are Harmonics, Flicker, Radiated and
Conducted Emission, Surge Immunity, and Voltage Dips, ESD, Radiated RFI, EFT, Conducted RFI, and Power
Frequency Magnetic Immunity should not affect the performance of this product; at the levels required in
EN60601-1-2:2001.

± 6kV Contact
± 8kV Air

±2kV Mains
±1kV I/Os

±1kV Differential
±2kV Common

>95% Dip for 0.5 Cycle

for 5 Cycles

60% Dip

30% Dip for 25 Cycles

>95% Dip for 5
Seconds

3 A/m Not Applicable,

Compliance

Level

Not Applicable,
See Note 1

Not Applicable,
See Note 1

±1kV Differential
Not Applicable

During each dip in
the mains voltage
the light will
flicker. During the
5-Second dropout,
the light shuts off,
but returns when
mains power is
restored. See
guidance at the
right.

See Note 1

Electromagnetic

Environment - Guidance

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

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.

Mains power quality should be
that of a typical commercial or
hospital environment. If the user
of the REF 73211 and its
powering accessories requires
that the light remain on during
the power outage, the system
must be powered from an
uninterruptible power supply or a
battery.

Power frequency magnetic fields
should be at levels characteristic
of a typical location in a typical
commercial or hospital
environment.

1-14

The REF 73211 and its powering accessories is intended for use in the electromagnetic environment

d

3.5

E

1

-------





P=

80 MHz to 800 MHz

d

3.5

V

1

-------





P=

d

7

E

1

------ -





P=

800 Mhz to 2.5 GHz

specified below. The customer or user of the REF 73211 and its powering accessories should assure that it is

Guidance and Manufacturer’s Declaration - Emissions

used in such an environment.

Immunity Test IEC 60601

Test Level

Conducted RF
IEC 61000-4-6

Radiated RF
IEC 61000-4-3

3 Vrms
150 kHz to 80MHz
(outside ISM bands)

3 V/m
80 MHz to 2.5 GHz

Compliance

Level

Not Applicable,
See Note 1

Not Applicable,
See Note 1

Electromagnetic

Environment - Guidance

Portable and mobile RF
communications equipment
should be used no closer to
any part of the REF 73211 and
its powering accessories,
including cables, than the
recommended separation
distances calculated below:

Where P is the max power in
watts and d is the
recommended separation
distance in meters.

Field strengths from fixed
transmitters, as determined
by an electromagnetic site
survey, should be less than
the compliance levels (V1 and
E1). Interference may occur in
the vicinity of equipment
containing a transmitter.

Note 1: The REF 73211 and its power accessories are a simple power supply and a lamp. The only EMC test
events that could affect the performance or environment of the system are Harmonics, Flicker, Radiated and
Conducted Emission, Surge Immunity, and Voltage Dips, ESD, Radiated RFI, EFT, Conducted RFI, and Power
Frequency Magnetic Immunity should not affect the performance of this product; at the levels required in
EN60601-1-2:2001.

1-15

Recommended Separations Distances between portable and mobile RF

d

3.5

V

1

-------





P=

d

3.5

E

1

-------





P=

d

7

E

1

------ -





P=

Communications equipment and the REF 73211 and its powering accessories

The REF 73211 and its powering accessories is intended for use in the electromagnetic environment in

which radiated disturbances are controlled. The customer or user of the REF 73211 and its powering

accessories can help prevent electromagnetic interference by maintaining a minimum distance

between portable and mobile RF Communications Equipment (transmitters) and the REF 73211 and its

powering accessories as recommended below, according to the maximum output power of the

communications equipment.

Max
Output
Power
(Watts)

0.01 Not Applicable Not Applicable Not Applicable

0.1 Not Applicable Not Applicable Not Applicable

1 Not Applicable Not Applicable Not Applicable

10 Not Applicable Not Applicable Not Applicable

100 Not Applicable Not Applicable Not Applicable

Separation (m)

150kHz to 80MHz

Separation (m)

80 to 800MHz

Separation (m)

800MHz to 2.5GHz

1-16

Trouble Shooting Guide

Problem Possible Cause Solution

Rectal Light Handle is not
plugged into the power
supply.

Power Supply is not
plugged in.

Lamp does not
light.

Rectal Light
Handle does not
stay plugged
into the
transformer
cord.

Light output
seems low.

This guide is intended to provide assistance towards determining the fault
condition of this product. Please contact the authorized Welch Allyn Service
Center listed within the product owners manual for additional assistance.

Faulty Lamp Replace with a new lamp.

Loose Lamp

Wrong Lamp

Damaged Lamp

Rectal Light Handle/
transformer interconnect
plug is damaged.

Faulty Lamp Replace with a new lamp.

Dirty lamp lens

Verify that the Rectal Light Handle
is properly plugged into power
supply cord.

Verify the power supply is properly
plugged into the outlet.

Verify that the lamp is secured into
the Rectal Light Handle.

Verify that the lamp is a REF
07800 Welch Allyn lamp.

Inspect the lamp and the o-ring for
damage. Replace with REF 07800
lamp if damage is found.

Inspect interconnect plug for
damage. Replace either or both
REF 73211 or REF 73305, 73322,
73324, 73326.

Inspect lamp lens for debris and
clean.

1-17

Troubleshooting Guide - Qualified Personnel Only

Problem Possible Cause Solution

No power to the power
supply outlet.

Faulty Power Supply.

Lamp does not
light.

Faulty Rectal Light
Handle.

Light output
seems low.

This guide is intended to provide assistance towards determining the fault
condition of this product. Please contact the authorized Welch Allyn Service
Center listed within the product owners manual for additional assistance.

Improper voltage
supplied to the
transformer.

Verify that power is supplied to
power supply outlet.

Test the voltage supplied through
the power supply at the cord end.
Verify the voltage reads
approximately 6.0 volts DC (REF
73305, 73322, 73324, 73326).
Only properly trained personnel
shall perform this test.

Verify that the Rectal Light Handle
is faulty by replacing with a new
Rectal Light Handle or with power
supplied through the transformer
(above), remove lamp and
measure the voltage between the
lamp socket center contact and
socket threads. Verify voltage
reads approximately 6.0 volts (DC
with REF 73305, 73322, 73324,

73326). Only properly trained
personnel shall perform this test.

Verify the voltage supplied to the
transformer outlet meets the
requirements stated in this
manual.

1-18

Warranty and Service

Limited Warranty

Instrumentation purchased new from Welch Allyn, Inc. (Welch Allyn) is
warranted to be free from original defects in material and workmanship
under normal use and service for a period of one year for Welch Allyn
Rectal Light Handle (REF 73211) and the Power Supply (REF 73305,
73322, 73324, 73326) from the date of first shipment from Welch Allyn.
This warranty shall be fulfilled by Welch Allyn or its authorized
representative repairing or replacing at Welch Allyn’s discretion, any such
defect, free of charge for parts and labor.

Welch Allyn must be notified via telephone of any defective product and
the item must be immediately returned, with a Service Notification
number provided by Welch Allyn, securely packaged and postage prepaid
to Welch Allyn. Loss or damage in shipment shall be at the purchaser’s
risk.

Welch Allyn will not be responsible for loss associated with the use of
any Welch Allyn product that (1) has had the date of manufacture number
defaced, (2) has been repaired by anyone other than an authorized Welch
Allyn Service Representative, (3) has been altered, (4) has been used in a
manner other than in accordance with the instructions, or (5) has been
abused or exposed to extreme environmental conditions.

THIS WARRANTY IS EXCLUSIVE AND IN LIEU OF ANY IMPLIED
WARRANTY OR MERCHANTABILITY, FITNESS FOR PARTICULAR
PURPOSE, OR OTHER WARRANTY OF QUALITY, WHETHER
EXPRESSED OR IMPLIED. WELCH ALLYN WILL NOT BE LIABLE FOR
ANY INCIDENTAL OR CONSEQUENTIAL DAMAGES RESULTING FROM
THE SALE, USE, OR IMPROPER FUNCTIONING OF THE
INSTRUMENTATION REGARDLESS OF THE CAUSE. THE DAMAGES
FOR WHICH WELCH ALLYN WILL BE RESPONSIBLE INCLUDE, BUT
ARE NOT LIMITED TO, LOSS OF REVENUE OR PROFIT, DOWNTIME
COSTS, AND LOSS OF USE OF THE INSTRUMENTATION.

Technical Assistance

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
under Welch Allyn Service Centers.

1-19

Prior to contacting Welch Allyn or its service center, please refer to the
following areas of the illuminator and/or transformer to identify the date
of manufacture of the component(s).

• Rectal Light Handle: Four digits, month then year, stamped next to the
REF 73211 label on the Rectal Light Handle sleeve.

• Power Supply: Four digits, week then year stamped or labeled on the
prong side of the transformer plug.

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 returning a product for repair you must obtain authorization from
Welch Allyn. Service Notification number will be given to you by our
service personnel. Be sure to note this number on the outside of your
shipping box. Returns without a Service Notification number will not be
accepted for service. Prior to shipment, please clean and disinfect the
component as instructed in this manual.

1-20

Welch Allyn Service Centers

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

USA [phone]

+ 1 315 685 4560

Canada [phone] China [phone]

European Call Center [phone] France [phone]

Germany [phone] Japan [phone]

Latin America [phone] Netherlands [phone]

Singapore [phone] South Africa [phone]

United Kingdom [phone] Sweden [phone]

Australia [phone]

[phone]

1-21

1-22

Table des Matières

Description des symboles . . . . . . . . . . . . . . . . . .2-1

Mises en gardes et avertissements . . . . . . . . . .2-1

Mode d'emploi . . . . . . . . . . . . . . . . . . . . . . . . . .2-4

Référence 73305, 73322, 73324, 73326

(blocs d’alimentation) . . . . . . . . . . . . . . . . . .2-4

Tube d’éclairage rectal référence 73211 . . . . . . . . 2-6

Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-9

Maintenance préventive . . . . . . . . . . . . . . . . . . . . .2-9

Remplacement de la lampe . . . . . . . . . . . . . . . . . . 2-9

Nettoyage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-10

Élimination . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-12

Spécifications . . . . . . . . . . . . . . . . . . . . . . . . . .2-13

Autorisations . . . . . . . . . . . . . . . . . . . . . . . . . . .2-14

Guidance and Manufacturer’s Declaration . . . . . .2-15

Guide de dépannage . . . . . . . . . . . . . . . . . . . . .2-19

Guide de dépannage - Personnel qualifié

uniquement . . . . . . . . . . . . . . . . . . . . .2-20

Garantie et entretien . . . . . . . . . . . . . . . . . . . . .2-21

Garantie limitée . . . . . . . . . . . . . . . . . . . . . . . . . .2-21

Assistance technique . . . . . . . . . . . . . . . . . . . . . .2-22

Centres d’entretien Welch Allyn . . . . . . . . . . . . . .2-23

Merci d’avoir acheté le tube d’éclairage rectal Welch Allyn référence 73211
et/ou le bloc d’alimentation référence 73305, 73322, 73324, 73326.
Veuillez consulter ce manuel avant d’utiliser le système.

L’utilisation du tube d’éclairage rectal 73211 et de son bloc d’alimentation
approprié, en conjonction avec les dispositifs Welch Allyn présentés dans
le tableau de la page 2-8 est exclusivement réservée aux médecins ayant
été formés correctement aux examens endoscopiques.

Le tube d’éclairage rectal 73211 est conçu pour être branché
exclusivement sur la source d’alimentation, en utilisant la tension et le
style de prise (indiqués dans ce manuel) appropriés au pays concerné.
Aucune autre utilisation de ces produits n’est escomptée ni conseillée.
Veuillez suivre les directives de ce manuel pour brancher et utiliser
correctement le tube d’éclairage rectal.

Classification

Classe II, pièce appliquée de type BF, équipement ordinaire

Fonctionnement intermittent

Description des symboles

Attention, Mise en garde,
Avertissement : Reportez­vous au mode d’emploi.

Avertissement, températures
élevées

Avertissement, intensité
lumineuse élevée

Double isolation IPXØ

Pièce appliquée de type BF

- - - Courant continu

Courant alternatif

Non protégé contre la
pénétration de l’eau.

Mises en gardes et avertissements

MISE EN GARDE : Ne regardez pas directement dans le faisceau
lumineux pour éviter toute lésion oculaire.

2-1

MISE EN GARDE : Tout contact cutané avec la lampe est dangereux
lorsqu’elle est chaude. Laissez la lampe refroidir pendant au moins 5
minutes avant de la remplacer.

MISE EN GARDE : Le tube d’éclairage rectal n’est pas adapté aux
utilisations en présence d’un mélange anesthésique inflammable
contenant de l’air, de l’oxygène ou de l’oxyde nitreux. Une explosion
pourrait se produire.

MISE EN GARDE : La lampe génère de la chaleur et doit toujours rester
éteinte lorsqu’elle n’est pas utilisée. Ne placez pas le tube d’éclairage
rectal sur une surface inflammable s'il est allumé ou chaud.

MISE EN GARDE : Débranchez le bloc d’alimentation de la prise avant
toute procédure de maintenance.

MISE EN GARDE : Utilisez exclusivement les blocs d’alimentation de 6
V décrits dans ce manuel avec le tube d’éclairage rectal 73211. Ne pas
respecter cette mise en garde risque de provoquer l’endommagement
du bloc d’alimentation et/ou du dispositif non approuvé.

MISE EN GARDE : L’utilisation d’accessoires, de transducteurs et/ou de
câbles autres que ceux spécifiés, à l’exception de ceux vendus par le
fabricant en tant que pièces de rechange pour les composants internes,
risque de provoquer l’augmentation des émissions ou la diminution de
l’immunité de l’équipement ou du système.

AVERTISSEMENT : La loi fédérale des États-Unis limite la vente de cet
instrument à un médecin ou sur ordonnance d’un médecin.

AVERTISSEMENT : L’éclairage du tube d’éclairage rectal est intense.
AVERTISSEMENT : Cet accessoire endoscopique est destiné à être

utilisé exclusivement avec les dispositifs Welch Allyn présentés dans le
tableau de la page 2-8. N’utilisez pas l’illuminateur de quelque autre
manière que ce soit.

AVERTISSEMENT : Utilisez exclusivement les méthodes de nettoyage
décrites dans ce manuel.

AVERTISSEMENT : Outre la lampe, ce dispositif ne contient aucune
pièce pouvant être entretenue par l’utilisateur. Contactez l’un des
centres d’entretien agréés de la page 2-23 pour toute question relative
à l’entretien.

AVERTISSEMENT : Le tube d’éclairage rectal 73211 est conçu pour être
branché exclusivement sur la source d’alimentation, en utilisant la tension
et le style de prise (indiqués dans ce manuel) appropriés dans le pays
concerné. Aucune autre utilisation de ces produits n’est escomptée ni
conseillée.

AVERTISSEMENT : Les équipements électriques médicaux doivent
faire l’objet de précautions spéciales dans le domaine de la
compatibilité électromagnétique, et doivent être installés et mis en
service conformément aux informations sur la compatibilité
électromagnétique qui commencent à la page 2-15.

AVERTISSEMENT : Les équipements de communication RF portables
et mobiles peuvent affecter les équipements électriques médicaux.

2-3

Mode d'emploi

Le bloc d’alimentation du tube d’éclairage rectal (référence 73305, 73322, 73324,

73326) permet de transférer l’alimentation d’une prise murale appropriée au tube
d’éclairage rectal (référence 73211) qui abrite la lampe (référence 07800). Le tube
d'éclairage rectal et son bloc d’alimentation approprié constituent un système
d’éclairage destiné à être utilisé avec les dispositifs et/ou accessoires Welch Allyn
(voir le tableau à la page 2-8).

Référence 73305, 73322, 73324, 73326 (blocs d’alimentation)

Veillez à ce que le bloc d’alimentation soit branché sur une prise appropriée et que
le courant fourni par la prise soit compris dans la plage spécifiée par le tableau
fourni.

Réf.

73305 120 V 60 Hz 71 110 - 130
73322 230 V 50 Hz 30 210 - 230
73324 240 V 50 Hz 27 230 - 250
73326 234 V 50 Hz 27 230 - 250

Tension entrée

nom.

Courant entrée

à tension entrée

nom. (mA)

Plage tension

entrée (V)

Style prise

A

B

C

D

2-4

Type de prise

ABC D

États-Unis

NEMA 1-15P

EUROPE

CEE 7/16

RU

BS 1363

AUSTRALIE /
NOUVELLE­ZÉLANDE

AS 3112

Insérez le bloc d’alimentation dans une prise de
tension et de configuration appropriées.

Dès que le bloc d’alimentation est branché
correctement, la DEL verte de son boîtier
s’allume pour indiquer que le cordon du bloc
d’alimentation transmet bien le courant.

2-5

Tube d’éclairage rectal référence 73211

Référence 73305 (présenté)
Référence 73322
Référence 73324
Référence 73326

Référence 73211

Référence 38700

Référence 36019

Série référence 38/39

Série référence 37

Référence 53110

Série référence 32

Référence 53130

Attachez le tube d'éclairage rectal 73211 au dispositif approprié
(sélectionné dans le tableau de la page 2-8).

2-6

Pour monter/démonter le système du tube d'éclairage rectal :

Port d'entrée

73211

1. Sélectionnez le dispositif approprié dans le tableau de la page 2-8.

2. Insérez le tube d'éclairage rectal 73211 sur le port d’entrée rectangulaire du
dispositif tout en tournant le bouton du 73211 dans le sens de « Release »
comme montré. Lâchez le bouton et vérifiez que le tube d'éclairage rectal est
bien attaché au dispositif.

3. Branchez le bloc d’alimentation référence 73305, 73322, 73324 ou 73326 sur
une prise appropriée.

4. Alignez la fiche de l’extrémité du cordon du tube d’éclairage rectal sur le
connecteur de l’extrémité du bloc d’alimentation, puis effectuez la
connexion. La lampe du 73211 s’allume immédiatement.

5. Débranchez le tube d'éclairage rectal du bloc d’alimentation pour éteindre la
lampe.

6. Pour retirer le dispositif du tube d’éclairage rectal, tournez le bouton du
73211 dans le sens de « release », puis retirez le 73211 du port d’entrée du
dispositif.

2-7

Le tube d'éclairage rectal (référence 73211) et le bloc d’alimentation
(référence 73305, 73322, 73324, 73326) sont conçus pour fonctionner
avec les dispositifs Welch Allyn suivants dans le cadre des procédures
endoscopiques :

Tube rectal Welch Allyn 73211

Série 32 Séries 38/39 avec 38700

32010 Sig. FO pédiatrique 11 mm x 10 cm 38108 Spéc. anus. std 8 mm x 89 mm

32020 Sig. FO de striction 11 mm x 25 cm 38114 Spéc. anus. std 14 mm x 89 mm

32410 Sig. FO pédiatrique 15 mm x 15 cm 38119 Spéc. anus. std 19 mm x 89 mm

32420 Sig. FO 15 mm x 25 cm 38122 Spéc. anus. std 22 mm x 89 mm

32810 Sig. FO std 19 mm x 15 cm 38900 Spéc. anus. rotatif 20 mm x 68 mm

32820 Sig. FO std 19 mm x 25 cm 38614 Spéc. anus. opé. 14 mm x 89 mm

33830 Sig. FO std 19 mm x 30 cm 38619 Spéc. anus. opé. 19 mm x 89 mm

32830 Sig. FO std 10 mm x 35 cm 38622 Spéc. anus. opé. 22 mm x 89 mm

33220 Sig. FO std 23 mm x 25 cm 39614 Spéc. anus. long 14 mm x 127 mm

33620 Sig. FO std 27 mm x 25 cm 39619 Spéc. anus. long 19 mm x 127 mm

Série 37

37019 Anuscope FO 19 mm x 7 cm

37023 Anuscope FO 23 mm x 7 cm 53130 Sig. jet. KleenSpec 19 mm x 25 cm

37027 Anuscope FO 27 mm x 7 cm 53110 Anuscope jetable

39622 Spéc. anus. long 22 mm x 127 mm

Jetables avec 36019

2-8

Maintenance

Sens des aiguilles

d'une montre

Sens inverse des aiguilles d’une montrere

Joint torique

Lampe référence 07800

Manchon du tube d'éclairage rectal

Maintenance préventive

Examinez mensuellement les cordons, les connexions et le boîtier du
transformateur pour vérifier qu’ils ne sont ni usés ni endommagés.

Nettoyez le tube d’éclairage rectal après chaque utilisation,
conformément à la section sur le nettoyage de ce manuel.

Remplacement de la lampe

REMARQUE : La lampe est la seule pièce du tube d’éclairage rectal
(référence 73211) pouvant être entretenue par l’utilisateur. Reportez-vous
à la figure ci-dessus pour vous aider visuellement lors du remplacement
de la lampe.

1. Débranchez le système du bloc d’alimentation de sa prise murale, puis
débranchez le tube d’éclairage rectal du cordon du bloc d’alimentation.
Laissez la lampe refroidir pendant au moins 5 minutes.

2. Dévissez le manchon extérieur du tube d’éclairage rectal en le tournant dans
le sens inverse des aiguilles d’une montre pour exposer la lampe, tel que
présenté.

3. Dévissez la lampe (sens inverse des aiguilles d’une montre) du corps du tube
d’éclairage rectal.

4. Inspectez la douille de la lampe du tube d’éclairage rectal pour vérifier qu’elle
ne présente pas de dommages ou d’irrégularités. Contactez l’un des centres
d’entretien agréés de la page 2-23 si vous détectez des irrégularités.

5. Utilisez une lampe Welch Allyn neuve. Vérifiez que sa référence est 07800 et
que le joint torique est présent et en bon état.

6. Vissez la lampe (sens des aiguilles d’une montre) dans le corps du tube
d’éclairage rectal et serrez-la suffisamment pour comprimer le joint torique.

2-9

7. Vissez le manchon du tube d’éclairage rectal (sens des aiguilles d’une
montre) dans le corps du tube d’éclairage rectal et serrez suffisamment pour
que le tube soit bien attaché.

8. Branchez le bloc d’alimentation sur la prise murale appropriée, puis
reconnectez le cordon du tube d’éclairage rectal au cordon du bloc
d’alimentation. Vérifiez que la lampe est bien allumée.

9. Si la lampe ne s’allume pas, reportez-vous à la section sur le dépannage, à la
page 2-19 ou contactez votre centre d’entretien local (page 2-23) pour de
plus amples informations.

Nettoyage

Numéros de référence 73210 et 73211

(y compris lampe 07800-U)

Numéro de référence 73500

(y compris lampe 03100-U)

AVERTISSEMENT Laisser refroidir la lampe pendant au moins 5
minutes avant de la manipuler.

Remarque Laisser la lampe en place lors du retraitement de 73210,
73211 et 73500.

Instructions d’assemblage et de désassemblage pour 73210 et 73211

1. Déconnecter la poignée d’éclairage du cordon d’alimentation et du dispositif.

2. Dévisser le manchon externe de la poignée en le tournant dans le sens
inverse des aiguilles d'une montre.

2-10

3. Suivre l’une des méthodes de retraitement décrites ci-dessous.

Sens des aiguilles d'une
montre

Sens inverse des aiguilles d'une montre

Manchon externe de la
poignée d’éclairage rectal

Cordon et corps de la poignée
d’éclairage rectal

4. Après exécution d’une procédure de retraitement, essuyer la lampe avec un
chiffon doux, sec, non pelucheux.

5. Refixer le manchon propre à la poignée en le vissant dans le sens des
aiguilles d'une montre.

6. Reconnecter le cordon d’alimentation à la poignée d’éclairage et brancher
l’unité pour vérifier qu’elle fonctionne. Si la lampe ne s’allume pas, suivre les
instructions de dépannage du manuel de la poignée d’éclairage ( 700791)
fourni avec votre poignée.

Nettoyage (73210, 73211 et 73500)

1. Préparer un détergent enzymatique conçu pour des instruments
endoscopiques conformément aux instructions du fabricant. Ces instructions
ont été validées pour utilisation avec ENZOL/CIDEZYME.

2. Immerger l'élément dans la solution de nettoyage.

3. À l’aide d’une brosse à poils doux, frotter l’élément immergé dans la solution
de nettoyage pendant au moins 5 minutes, puis le rincer dans de l’eau stérile
pendant 5 minutes.

Désinfection de niveau intermédiaire (73210, 73211 et

73500)

1. Suivre les instructions de nettoyage ci-dessus.

2. À l’aide de CaviWipes™, essuyer toutes les surfaces de l’élément et les
laisser imprégnées d’une solution CaviWipe pendant au moins 5 minutes.

3. Laisser sécher la surface de l’élément pendant au moins 10 minutes.

2-11

Stérilisation (73211 UNIQUEMENT)

Attention Le passage en autoclave de la poignée d’éclairage
peut réduire la durée de vie fonctionnelle du produit.

1. Suivre les instructions de nettoyage ci-dessus.

2. Exécuter un cycle d’autoclave pendant 6 minutes à 132 °C suivi d’une
période de refroidissement de 15 minutes au moins. Ces instructions ont été
validées à l’aide d’un autoclave à gravité. Valider tout autre équipement de
stérilisation et configuration de charge.

Élimination

Aucun matériau dangereux n’est associé au système du tube d’éclairage
rectal.

Aucun risque n’est associé à ce dispositif lorsqu’il est éliminé après avoir
été utilisé, dans la mesure où il a été nettoyé conformément aux
instructions de ce manuel.

2-12

Spécifications

Classification : Classe II, pièce appliquée de type BF

Entrée : 100 à 240 V , 50/60 Hz, 200 mA

Sortie : 6,0 V , 1150 mA

Catégorie : Pas un équipement AP/APG

Spécifications physiques :

Tube d’éclairage rectal : 96 mm (3,775 po.) x 25 mm (1,00 po.), 104 grammes

(3,67 onces)

Bloc d’alimentation : 43 mm (1,71 po.) L x 52 mm (2,06 po.) l x 55 mm

(2,18 po.) H

Cordon du bloc d’alimentation : 183 cm (71,4 po.)

Éclairage :

Durée de la lampe : 75 heures
Tension de la lampe : 6 V
Lampe : Welch Allyn référence 07800

Caractéristiques IPX : IPXØ

Environnement

Fonctionnement : +10 à + 35 °C (50 à 95 °F), HR 95 %

500 à 1 060 hPa

Transport/Rangement : -20 à +49 °C (-2 à 120 °F), HR 95 %,

500 à 1 060 hPa

Fonctionnement intermittent 10 minutes de marche max. ; 5 minutes
Tube d’éclairage rectal d’arrêt min.

2-13

Autorisations

74227

US

74227

L

I

S

T

E

D

L

I

S

T

E

D

C

CM

I

N

T

E

R

T

E

K

EC REP

N344

CERTIFICATIONS : CAN/CSA STD C22.2 NO.

601.1

CONFORME À : EN/IEC 60601-1, UL 60601-1,
EN/IEC 60601-1-2, EN/IEC 60601-2-18

La marque CE de ce produit indique que les
résultats des tests auxquels il a été soumis
sont conformes aux dispositions enregistrées
dans la Directive 93/42/CEE concernant les
appareils médicaux.

European Regulatory Manager

European Regulatory Manager
Welch Allyn Ltd.
Navan Business Park
Dublin Road
Navan, County Meath, Republic of Ireland
Tel.: [phone] • Fax: [phone]

Australie AS/NZS 3200.1

2-14

Guidance and Manufacturer’s Declaration

The REF 73211 and its powering accessories is intended for use in the electromagnetic environment specified

below. The customer or user of the REF 73211 and its powering accessories should assure that it is used in

such an environment.

Emissions Test Compliance Electromagnetic Environment - Guidance

Emissions for all EQUIPMENT and SYSTEMS

RF Emissions
CISPR 11

RF Emissions
CISPR 11

Harmonics
IEC 61000-3-2

Flicker
IEC 31000-3-3

Group 1 The REF 73211 and its powering accessories uses RF

Class B The REF 73211 and its powering accessories is suitable for

Class A

Complies

energy for its internal function. Therefore, its RF emissions
are very low and are not likely to cause interference in
nearby electronic equipment.

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.

2-15

The REF 73211 is intended for use in the electromagnetic environment specified below. The customer or user

of the REF 73211 should assure that it is used in such an environment.

Electromagnetic Immunity for all EQUIPMENT and SYSTEMS

Immunity Test IEC 60601

Test Level

ESD
IEC 61000-4-2

EFT
IEC 61000-4-4

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

Note 1: The REF 73211 and its power accessories are a simple power supply and a lamp. The only EMC test
events that could affect the performance or environment of the system are Harmonics, Flicker, Radiated and
Conducted Emission, Surge Immunity, and Voltage Dips, ESD, Radiated RFI, EFT, Conducted RFI, and Power
Frequency Magnetic Immunity should not affect the performance of this product; at the levels required in
EN60601-1-2:2001.

± 6kV Contact
± 8kV Air

±2kV Mains
±1kV I/Os

±1kV Differential
±2kV Common

>95% Dip for 0.5 Cycle

for 5 Cycles

60% Dip

30% Dip for 25 Cycles

>95% Dip for 5
Seconds

3 A/m Not Applicable,

Compliance

Level

Not Applicable,
See Note 1

Not Applicable,
See Note 1

±1kV Differential
Not Applicable

During each dip in
the mains voltage
the light will
flicker. During the
5-Second dropout,
the light shuts off,
but returns when
mains power is
restored. See
guidance at the
right.

See Note 1

Electromagnetic

Environment - Guidance

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

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.

Mains power quality should be
that of a typical commercial or
hospital environment. If the user
of the REF 73211 and its
powering accessories requires
that the light remain on during
the power outage, the system
must be powered from an
uninterruptible power supply or a
battery.

Power frequency magnetic fields
should be at levels characteristic
of a typical location in a typical
commercial or hospital
environment.

2-16

The REF 73211 and its powering accessories is intended for use in the electromagnetic environment

d

3.5

E

1

-------





P=

80 MHz to 800 MHz

d

3.5

V

1

-------





P=

d

7

E

1

------ -





P=

800 Mhz to 2.5 GHz

specified below. The customer or user of the REF 73211 and its powering accessories should assure that it is

Guidance and Manufacturer’s Declaration - Emissions

used in such an environment.

Immunity Test IEC 60601

Test Level

Conducted RF
IEC 61000-4-6

Radiated RF
IEC 61000-4-3

3 Vrms
150 kHz to 80MHz
(outside ISM bands)

3 V/m
80 MHz to 2.5 GHz

Compliance

Level

Not Applicable,
See Note 1

Not Applicable,
See Note 1

Electromagnetic

Environment - Guidance

Portable and mobile RF
communications equipment
should be used no closer to
any part of the REF 73211 and
its powering accessories,
including cables, than the
recommended separation
distances calculated below:

Where P is the max power in
watts and d is the
recommended separation
distance in meters.

Field strengths from fixed
transmitters, as determined
by an electromagnetic site
survey, should be less than
the compliance levels (V1 and
E1). Interference may occur in
the vicinity of equipment
containing a transmitter.

Note 1: The REF 73211 and its power accessories are a simple power supply and a lamp. The only EMC test
events that could affect the performance or environment of the system are Harmonics, Flicker, Radiated and
Conducted Emission, Surge Immunity, and Voltage Dips, ESD, Radiated RFI, EFT, Conducted RFI, and Power
Frequency Magnetic Immunity should not affect the performance of this product; at the levels required in
EN60601-1-2:2001.

2-17

Recommended Separations Distances between portable and mobile RF

d

3.5

V

1

-------





P=

d

3.5

E

1

-------





P=

d

7

E

1

------ -





P=

Communications equipment and the REF 73211 and its powering accessories

The REF 73211 and its powering accessories is intended for use in the electromagnetic environment in

which radiated disturbances are controlled. The customer or user of the REF 73211 and its powering

accessories can help prevent electromagnetic interference by maintaining a minimum distance

between portable and mobile RF Communications Equipment (transmitters) and the REF 73211 and its

powering accessories as recommended below, according to the maximum output power of the

communications equipment.

Max
Output
Power
(Watts)

0.01 Not Applicable Not Applicable Not Applicable

0.1 Not Applicable Not Applicable Not Applicable

1 Not Applicable Not Applicable Not Applicable

10 Not Applicable Not Applicable Not Applicable

100 Not Applicable Not Applicable Not Applicable

Separation (m)

150kHz to 80MHz

Separation (m)

80 to 800MHz

Separation (m)

800MHz to 2.5GHz

2-18

Guide de dépannage

Problème Cause possible Solution

Le tube d’éclairage rectal
n’est pas branché sur le
bloc d’alimentation.

Le bloc d’alimentation
n’est pas branché.

Lampe défectueuse

La lampe ne
s’allume pas.

Le tube
d’éclairage
rectal ne reste
pas branché sur
le cordon du
transformateur.

L’éclairage
semble faible.

Ce guide est destiné à vous aider à déterminer la défaillance de ce produit. Pour
toute assistance supplémentaire, veuillez contacter le centre d’entretien Welch
Allyn indiqué dans le manuel d’utilisation.

Lampe desserrée

Mauvaise lampe

Lampe endommagée

La fiche d’interconnexion
du tube d’éclairage
rectal/transformateur est
endommagée.

Lampe défectueuse

Lentille de la lampe sale

Vérifiez que le tube d’éclairage
rectal est bien branché sur le
cordon du bloc d’alimentation.

Vérifiez que le bloc d’alimentation
est bien branché sur la prise.

Remplacez-la par une nouvelle
lampe.

Vérifiez que la lampe est bien
calée dans le tube d’éclairage
rectal.

Vérifiez qu’il s’agit d’une lampe
Welch Allyn référence 07800.

Vérifiez que la lampe et le joint
torique ne sont pas endommagés.
Remplacez par une lampe
référence 07800 en cas de
dommages.

Vérifiez que la fiche
d’interconnexion n’est pas
endommagée. Remplacez-la par
l’une de ces références ou les
deux : référence 73211 ou
référence REF 73305, 73322,
73324, 73326.

Remplacez-la par une nouvelle
lampe.

Vérifiez qu'il n'y a pas de débris
sur la lampe et nettoyez-la si
nécessaire.

2-19

Guide de dépannage - Personnel qualifié uniquement

Problème Cause possible Solution

La prise du bloc
d’alimentation n’est pas
alimentée.

Bloc d’alimentation
défectueux.

La lampe ne
s’allume pas.

Tube d’éclairage rectal
défectueux

L’éclairage
semble faible.

Ce guide est destiné à vous aider à déterminer la défaillance de ce produit. Pour
toute assistance supplémentaire, veuillez contacter le centre d’entretien Welch
Allyn indiqué dans le manuel d’utilisation.

Une tension incorrecte
est fournie au
transformateur.

Vérifiez que la prise du bloc
d’alimentation est alimentée.

Testez la tension fournie par le
bloc d’alimentation à l’extrémité
du cordon. Vérifiez que la tension
est d’environ 6,0 volts CC
(référence 73305, 73322, 73324,

73326). Ce test est exclusivement
réservé aux techniciens qualifiés.

Vérifiez que le tube d’éclairage
rectal est défectueux en le
remplaçant par un nouveau tube
d’éclairage rectal ou, l’alimentation
étant fournie par l’intermédiaire du
transformateur (voir ci-dessus),
retirez la lampe et mesurez la
tension entre le contact du centre
de la douille et son filetage.
Vérifiez que la tension est
d’environ 6,0 volts CC (avec
référence 73305, 73322, 73324,

73326). Ce test est exclusivement
réservé aux techniciens qualifiés.

Vérifiez que la tension fournie à la
prise du transformateur est
conforme aux exigences indiquées
dans ce manuel.

2-20

Garantie et entretien

Garantie limitée

Les instruments achetés à l’état neuf auprès de Welch Allyn, Inc. (Welch
Allyn) sont garantis contre tout vice de matériaux et de fabrication, dans
des conditions normales d’utilisation et d’entretien, pendant une période
d’un an, à compter de la première expédition de Welch Allyn, pour le tube
d’éclairage rectal Welch Allyn (référence 73211) et le bloc d’alimentation
(référence 73305, 73322, 73324, 73326). La présente garantie est
exécutée par Welch Allyn ou par l’un de ses représentants agréés, qui
réparera ou remplacera, à sa discrétion, n’importe lequel desdits vices,
les pièces et la main-d’oeuvre étant gratuites.

Welch Allyn doit être averti par téléphone de tout produit défectueux, et
l’élément doit être renvoyé immédiatement à Welch Allyn avec le numéro
de notification d’entretien fourni par Welch Allyn, emballé de manière
sécuritaire, en port payé. L’acheteur assume tout risque de perte ou
d’endommagement pendant le transport.

Welch Allyn ne sera pas tenu responsable des pertes associées à
l’utilisation d’un produit Welch Allyn (1) dont le numéro de la date de
fabrication est dégradé, (2) qui a été réparé par un individu autre qu’un
représentant d’entretien Welch Allyn agréé, (3) qui a été modifié, (4) qui a
été utilisé d’une manière non conforme aux instructions, ou (5) qui a fait
l'objet d'une utilisation abusive ou a été exposé à des conditions
environnementales extrêmes.

LA PRÉSENTE GARANTIE EST EXCLUSIVE ET REMPLACE TOUTE
GARANTIE IMPLICITE OU GARANTIE DE VALEUR MARCHANDE,
D’APTITUDE À UN USAGE PARTICULIER OU AUTRE GARANTIE DE
QUALITÉ QU’ELLE SOIT EXPRESSE OU IMPLICITE. WELCH ALLYN NE
SERA RESPONSABLE D’AUCUN DOMMAGE ACCESSOIRE OU
INDIRECT RÉSULTANT DE LA VENTE, DE L’UTILISATION OU DU
FONCTIONNEMENT INCORRECT DE L’INSTRUMENTATION, QUELLE
QU’EN SOIT LA CAUSE. LES DOMMAGES DONT WELCH ALLYN EST
RESPONSABLE INCLUENT, SANS TOUTEFOIS S’Y LIMITER, LA PERTE
DE REVENU OU DE BÉNÉFICE, LES FRAIS D’INDISPONIBILITÉ ET LA
PERTE DE L’UTILISATION DE L’INSTRUMENTATION.

2-21

Assistance technique

Si vous ne parvenez pas à résoudre un problème d’équipement, appelez
le centre d’entretien Welch Allyn le plus proche pour toute assistance.
Une assistance technique téléphonique est disponible, pendant les jours
ouvrables, aux numéros de téléphone des centres d’entretien Welch
Allyn indiqués.

Avant de contacter Welch Allyn ou l’un de ses centres d’entretien,
veuillez vous reporter aux zones suivantes de l’illuminateur et/ou du
transformateur pour identifier la date de fabrication du(des) composant(s).

• Tube d’éclairage rectal : Quatre numéros, mois puis année, estampés à
côté de l’étiquette « REF 73211 » du manchon du tube d’éclairage rectal.

• Bloc d’alimentation : Quatre numéros, semaine puis année, estampés
ou étiquetés du côté des broches de la fiche du transformateur.

Si l'on vous conseille de renvoyer un produit à Welch Allyn pour
réparation ou entretien, adressez-vous au centre de réparation ou
d’entretien le plus proche.

Vous devez obtenir l’autorisation de Welch Allyn avant de renvoyer un
produit pour réparation. Notre personnel d’entretien vous fournira un
numéro de notification d’entretien. N'oubliez pas d'inscrire ce numéro à
l’extérieur du carton de réexpédition. Les renvois sans numéro de
notification d’entretien ne seront pas acceptés pour un entretien. Avant
l’expédition, veuillez nettoyer et désinfecter le composant conformément
aux instructions de ce manuel.

2-22

Centres d’entretien Welch Allyn

Pour plus d’informations sur les produits Welch Allyn, contacter
l’Assistance technique Welch Allyn :

États-Unis [phone]

[phone]

Canada [phone] Chine [phone]

Centre d’appels en

Allemagne [phone] Japon [phone]

Amérique latine [phone] Pays-Bas [phone]

Singapour [phone] Afrique du Sud [phone]

Royaume-Uni [phone] Suède [phone]

[phone] France [phone]

Europe

Australie [phone]

[phone]

2-23

2-24

Tabla de Contenidos

Descripciones de los símbolos . . . . . . . . . . . . . .3-1

Advertencias y precauciones . . . . . . . . . . . . . . . .3-1

Instrucciones de uso . . . . . . . . . . . . . . . . . . . . . .3-4

REF 73305, 73322, 73324, 73326

(fuentes de alimentación) . . . . . . . . . . . . . .3-4

Lámpara para examen rectal REF 73211 . . . . . . . .3-6

Mantenimiento . . . . . . . . . . . . . . . . . . . . . . . . . .3-9

Mantenimiento preventivo . . . . . . . . . . . . . . . . . . .3-9

Sustitución de la bombilla . . . . . . . . . . . . . . . . . . . .3-9

Limpieza . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-10

Eliminación . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-12

Especificaciones . . . . . . . . . . . . . . . . . . . . . . . .3-13

Homologaciones . . . . . . . . . . . . . . . . . . . . . . . .3-14

Guidance and Manufacturer’s Declaration . . . . . .3-15

Guía para la solución de problemas . . . . . . . . . .3-19

Guía para la solución de problemas: Personal

calificado exclusivamente . . . . . . . . . .3-20

Garantía y servicio técnico . . . . . . . . . . . . . . . . .3-21

Garantía limitada . . . . . . . . . . . . . . . . . . . . . . . . . .3-21

Asistencia técnica . . . . . . . . . . . . . . . . . . . . . . . . .3-22

Centros de servicio técnico de Welch Allyn . . . . .3-23

Gracias por comprar la lámpara para examen rectal Welch Allyn REF.
73211 y/o la fuente de alimentación REF. 73305, 73322, 73324, 73326.
Por favor revise este manual antes de utilizar este sistema.

Solamente los médicos con la formación adecuada en exámenes
endoscópicos deben usar la lámpara para examen rectal 73211 y su
fuente de alimentación adecuada cuando se acopla a los dispositivos
Welch Allyn indicados en la tabla de la página 3-8.

La lámpara para examen rectal 73211 está diseñada para conectarla
solamente a la fuente de alimentación y al voltaje apropiado del país y al
estilo de toma de corriente indicado en este manual. No se aconseja o
indica ningún otro uso de estos productos. Por favor, siga las
instrucciones de este manual para la conexión y uso correcto de la
lámpara para examen rectal.

Clasificación

Clase II, Parte aplicada tipo BF, equipo ordinario

Funcionamiento intermitente

Descripciones de los símbolos

Atención, advertencia,
precaución: Vea las
instrucciones de uso

Precaución, altas
temperaturas

Precaución, luz de gran
intensidad

Doble aislamiento IPXØ

Parte aplicada tipo BF

Corriente continua

- - -

Corriente alterna

No protegido contra la
entrada de agua.

Advertencias y precauciones

ADVERTENCIA: Para evitar lesiones oculares, no mire directamente al
haz de luz.

3-1

ADVERTENCIA: La lámpara es nociva para la piel si se toca cuando está
caliente. Deje que la lámpara se enfríe durante 5 minutos como mínimo
antes de cambiarla.

ADVERTENCIA: La lámpara para examen rectal y/o la fuente de
alimentación no están indicadas para usarse en presencia de una mezcla
de anestésico inflamable con aire, oxígeno u óxido nitroso. Puede
producirse una explosión.

ADVERTENCIA: La lámpara genera calor y debe permanecer apagada
hasta momentos antes de utilizarla y apagarla inmediatamente después
de usarla. No coloque la lámpara para examen rectal en una superficie
inflamable si la lámpara está encendida o caliente.

ADVERTENCIA: Desconecte la fuente de alimentación de la toma de
corriente antes de realizar cualquier tarea de mantenimiento.

ADVERTENCIA: Utilice solamente las fuentes de alimentación de 6 V
descritas en este manual con la lámpara para examen rectal 73211. Si
hace caso omiso a esta advertencia, podría dañar la fuente de
alimentación y/o el dispositivo no aprobado.

ADVERTENCIA: El uso de accesorios, transductores y/o cables diferentes
a los especificados, excepto aquellos vendidos por el fabricante como
piezas de repuesto para componentes internos, podría aumentar las
emisiones o disminuir la inmunidad del equipo o sistema.

PRECAUCIÓN: Las leyes federales estadounidenses restringen la venta
de este dispositivo a médicos o por prescripción facultativa.

PRECAUCIÓN: La luz de la lámpara para examen rectal es intensa.
PRECAUCIÓN: Este accesorio endoscópico debe utilizarse con los

dispositivos Welch Allyn indicados en la tabla de la página 3-8 solamente.
No utilice el iluminador para ningún otro uso.

PRECAUCIÓN: Utilice solamente los métodos de limpieza descritos en
este manual.

PRECAUCIÓN: No hay ninguna pieza en la que el usuario pueda realizar
tareas de servicio técnico dentro del dispositivo excepto la bombilla.
Póngase en contacto con el centro de servicio técnico autorizado indicado
en la página 3-23 para temas relacionados con el servicio técnico.

PRECAUCIÓN: La lámpara para examen rectal 73211 está diseñada para
conectarla solamente a la fuente de alimentación y al voltaje apropiado
del país y al estilo de toma de corriente indicado en este manual. No se
aconseja ni indica otro uso de estos productos.

PRECAUCIÓN: El equipo médico eléctrico necesita precauciones
especiales relacionadas con EMC y necesita ser instalado y puesto en
servicio de acuerdo a la información EMC que empieza en la página 3-15.

PRECAUCIÓN: El equipo portátil y móvil de comunicaciones de RF
puede afectar al equipo médico eléctrico.

3-3

Instrucciones de uso

La fuente de alimentación de la lámpara para examen rectal (REF 73305, 73322,
73324, 73326) suministra energía desde una toma de corriente adecuada en la
pared a la lámpara de examen rectal (REF 73211) que aloja la bombilla (REF 07800).
La lámpara para examen rectal y su fuente de alimentación adecuada proporciona
un sistema de iluminación que está indicado para usar con dispositivos y/o
accesorios Welch Allyn (véase la tabla de la página 3-8).

REF 73305, 73322, 73324, 73326 (fuentes de alimentación)

Compruebe que la fuente de alimentación está conectada a la toma de corriente
adecuada y que la corriente suministrada a dicha toma de corriente está dentro
del rango especificado en la tabla suministrada.

Corriente de

REF

Voltaje

nominal de

entrada

entrada al

voltaje nominal

de entrada

(mA)

Rango de
voltaje de

entrada (V.)

Estilo de

enchufe

73305 120V 60 Hz 71 110 - 130
73322 230V 50 Hz 30 210 - 230
73324 240V 50 Hz 27 230 - 250
73326 234V 50 Hz 27 230 - 250

3-4

A

B

C

D

Tipo de toma de corriente

ABC D

EE.UU.

NEMA 1-15P

EUROPA

CEE 7/16

Reino Unido

BS 1363

AUSTRALIA /
NUEVA ZELANDA

AS 3112

Inserte la fuente de alimentación en un enchufe
que tenga el voltaje y la configuración adecuada.

Una vez se haya conectado correctamente, el
diodo emisor de luz (LED) verde situado en la
carcasa de la fuente de alimentación se
iluminará lo que indica que pasa electricidad al
cable de alimentación.

3-5

Lámpara para examen rectal REF 73211

REF 73305 (MOSTRADA)
REF 73322
REF 73324
REF 73326

REF 73211

REF 38700

REF 36019

REF 38/39 Series

REF 37 Series

REF 53110

REF 32 Series

REF 53130

Conecte la lámpara para examen rectal al dispositivo adecuado
seleccionado en la tabla de la página 3-8.

3-6

Para ensamblar y desensamblar la lámpara para examen rectal:

Puerto de entrada

73211

1. Seleccione el dispositivo apropiado en la tabla de la página 3-8.

2. Inserte la lámpara para examen rectal 73211 en el “puerto de
entrada” rectangular de los dispositivos al mismo tiempo que gira el
botón de la lámpara 73211 en la dirección “liberar” como se muestra.
Suelte el botón y compruebe que la lámpara para examen rectal
73211 está bien acoplada al dispositivo.

3. Enchufe la fuente de alimentación REF 73305, 73322, 73324 ó 73326
en una toma de corriente adecuada.

4. Alinee el enchufe situado en el extremo del cable de la lámpara para
examen rectal con el conector situado en el extremo de la fuente de
alimentación y conéctelo. La bombilla de la lámpara para examen
rectal 73211 se encenderá inmediatamente.

5. Para apagar la bombilla, desconecte la lámpara para examen rectal de
la fuente de alimentación.

6. Para desconectar el dispositivo de la lámpara para examen rectal, gire
el botón de la lámpara en la dirección “liberar” y saque la lámpara
73211 del puerto de entrada del dispositivo.

3-7

La lámpara para examen rectal (REF 73211) y la fuente de alimentación
(REF 73305, 73322, 73324, 73326) están diseñadas para funcionar con
los siguientes dispositivos Welch Allyn para procedimientos
endoscópicos:

Mango rectal Welch Allyn 73211

32 Series 38/39 Series equipado con 38700

32010 Sig. pediátrico FO de 11 mm x 10 cm 38108

32020 Sig. FO estenosis de 11 mm x 25 cm 38114

32410 Sig. pediátrico FO de 15 mm x 15 cm 38119

32420 Sig. FO de 15 mm x 25 cm 38122

32810 Sig. estándar FO de 19 mm x 15 cm 38900

32820 Sig. estándar FO de 19 mm x 25 cm 38614

33830 Sig. estándar FO de 19 mm x 30 cm 38619

32830 Sig. estándar FO de 10 mm x 35 cm 38622

33220 Sig. estándar FO de 23 mm x 25 cm 39614

33620 Sig. estándar FO de 27 mm x 25 cm 39619

37 Series

37019 Anoscopio FO de 19 mm x 7 cm

39622

Desechables equipados con 36019

Espéc. anal estándar de 8 mm x
89 mm

Espéc. anal estándar de 14mm x
89 mm

Espéc. anal estándar de 19 mm x
89 mm

Espéc. anal estándar de 22 mm x
89 mm

Espéc. anal giratorio de 20 mm x
68 mm

Espéc. anal quirúrgico de 14 mm x
89 mm

Espéc. anal quirúrgico de 19 mm x
89 mm

Espéc. anal quirúrgico de 22 mm x
89 mm

Espéc. anal largo de 14 mm x
127 mm

Espéc. anal largo de 19 mm x
127 mm

Espéc. anal largo de 22 mm x
127 mm

37023 Anoscopio FO de 23 mm x 7 cm 53130

37027 Anoscopio FO de 27 mm x 7 cm 53110 Anoscopio desechable

Sig. desechable KleenSpec de
19 mm x 25 cm

3-8

Mantenimiento

Hacia la derecha (CW)

Hacia la izquierda (CCW)

Junta

Bombilla REF 07800

Manguito de la lámpara para examen rectal

Mantenimiento preventivo

Inspeccionar mensualmente los cables, las conexiones y la carcasa del
transformador para ver si presentan signos de daño o desgaste.

Después de cada uso, limpie la lámpara para examen rectal de acuerdo al
apartado “Limpieza” de este manual.

Sustitución de la bombilla

NOTA: La bombilla es la única parte que el usuario puede mantener o
cambiar en la lámpara para examen rectal (REF 73211). Consulte la figura
anterior como ayuda visual para cambiar la bombilla.

1. Desconecte la fuente de alimentación del sistema de la toma de corriente en
la pared y a continuación, desconecte la lámpara para examen rectal del
cable de alimentación. Deje que la lámpara se enfríe durante 5 minutos como
mínimo.

2. Desenrosque el manguito externo de la lámpara para examen rectal

3. Desenrosque la bombilla del cuerpo de la lámpara para examen rectal

4. Inspeccione el casquillo de la bombilla de la lámpara para examen

5. Utilizando una bombilla nueva de Welch Allyn, compruebe que el

girándolo hacia la izquierda (CCW) para dejar al descubierto la
bombilla como se muestra.

girándola hacia la izquierda (CCW).

rectal por si presentara daños o irregularidades. Si se encontrara
alguna irregularidad, póngase en contacto con el centro de servicio
técnico autorizado indicado en la página 3-23.

número de referencia de la bombilla es 07800, tiene la junta y está en
buenas condiciones.

3-9

6. Enrosque la bombilla girándola hacia la derecha (CW) en el cuerpo de
la lámpara para examen rectal y apriete lo suficiente para comprimir
la junta de la bombilla.

7. Enrosque el manguito de la lámpara para examen rectal girándolo
hacia la derecha (CW) en el cuerpo de la lámpara para examen rectal
y apriete lo suficiente para asegurarlo al dispositivo.

8. Conecte la fuente de alimentación a la toma de corriente adecuada
en la pared y vuelva a conectar el cable de la lámpara para examen
rectal al cable de alimentación y compruebe que se enciende la
bombilla.

9. Si la lámpara no se enciende, consulte el apartado “Solución de
problemas” de la (página 3-19) o póngase en contacto con su centro
local de servicio técnico (página 3-23) para obtener más asistencia.

Limpieza

Números de pieza 73210 y 73211

(lámpara 07800-U incluida)

ADVERTENCIA Deje que la lámpara se enfríe durante 5 minutos
como mínimo antes de manipularla.

NOTA Deje la lámpara instalada durante el reprocesamiento de 73210,
73211 y 73500.

Número de pieza 73500

(lámpara 03100-U incluida)

Instrucciones de montaje y desmontaje de 73210 y 73211.

1. Desconecte el mango de la lámpara del cable de la fuente de
alimentación y del dispositivo.

2. Desatornille la funda exterior del mango girándolo en sentido
contrario a las agujas del reloj.

3-10

3. Siga alguno de los métodos de reprocesamiento que se indican a

Sentido de las agujas del reloj

Sentido contrario a las agujas del reloj

Funda exterior del mango de la lámpara
para examen rectal

Cuerpo y cable del mango de la lámpara
para examen rectal

continuación.

4. Después de realizar el procedimiento de reprocesamiento, limpie la
lámpara con un paño suave, seco y libre de pelusas.

5. Vuelva a colocar la funda limpia en el mango atornillando en el
sentido de las agujas del reloj.

6. Vuelva a conectar el cable de la fuente de alimentación al mango de
la lámpara y enchufe la unidad para verificar que funcione. Si la
lámpara no se enciende, siga las instrucciones para la resolución de
problemas que aparecen en el manual del mango de la lámpara (

700791) que recibió junto con el producto.

Limpieza (73210, 73211 y 73500)

1. Prepare un detergente enzimático formulado para instrumentos
endoscópicos de acuerdo con las instrucciones del fabricante. Estas
instrucciones se validaron utilizando ENZOL/CIDEZYME.

2. Sumerja el elemento en la solución de limpieza.

3. Frote el elemento sumergido en la solución de limpieza con un cepillo
de cerdas suaves durante 5 minutos como mínimo y enjuáguelo
después con agua estéril durante 5 minutos.

Desinfección de nivel intermedio (73210, 73211 y 73500)

1. Siga las instrucciones de limpieza señaladas anteriormente.

™

2. Utilice toallitas CaviWipes
elemento y manténgalo húmedo con la solución CaviWipe durante al
menos 5 minutos.

para limpiar todas las superficies del

3-11

3. Deje secar la superficie del elemento durante 10 minutos como
mínimo.

Esterilización (73211 ÚNICAMENTE)

Precaución Esterilizar la lámpara para examen con autoclave
puede reducir la vida útil del producto.

1. Siga las instrucciones de limpieza señaladas anteriormente.

2. Realice un ciclo de autoclave de 6 minutos a 132 °C y con un período
de enfriamiento de 15 minutos como mínimo. Estas instrucciones se
validaron utilizando un autoclave de gravedad. Valide cualquier otro
equipo de esterilización y cargue las configuraciones.

Eliminación

No hay materiales perjudiciales asociados con el sistema de la lámpara
para examen rectal.

No hay riesgos asociados con la eliminación de este dispositivo después
de su vida útil si se limpia según las instrucciones de este manual.

3-12

Especificaciones

Clasificación: Clase II, Pieza aplicada tipo BF

Potencia de entrada: 100 a 240V , 50/60 Hz, 200 mA

Potencia de salida: 6,0V , 1150 mA

Categoría: Equipo no AP/APG

Especificaciones físicas:

Lámpara para examen rectal: 96mm (3,775") x 25mm (1,00"),

104 gramos (3,67 oz)

Fuente de alimentación: 43mm (1,71") largo x 52mm (2,06") ancho x 55mm

(2,18") alto

Cable de alimentación: 183 cm (71,4")

Iluminación:

Duración de la bombilla: 75 horas
Voltaje de la bombilla: 6 V
Bombilla: Welch Allyn REF 07800

Clasificación IPX: IPXØ

Entorno de funcionamiento: De +10° C a + 35° C (de 50° F a 95° F), HR del 95%

De 500 hPa a 1060 hPa

Transporte/almacenamiento: De -20° C a +49° C (de -2° F a 120° F),

HR del 95%, De 500 hPa a 1060 hPa

Funcionamiento intermitente
Lámpara para examen rectal
apagada mín. 10 minutos encendida máx.; 5 minutos

3-13

Homologaciones

74227

US

74227

L

I

S

T

E

D

L

I

S

T

E

D

C

CM

I

N

T

E

R

T

E

K

EC REP

N344

CERTIFICADO SEGÚN CAN/CSA STD C22.2 No.

601.1

EN CONFORMIDAD CON: EN/IEC 60601-1, UL
60601-1, EN/IEC 60601-1-2, EN/IEC 60601-2-18

La marca CE en este producto indica que se ha
puesto a prueba y se ajusta a las disposiciones
indicadas en la Directiva de dispositivos médicos
93/42/CEE.

European Regulatory Manager

European Regulatory Manager
Welch Allyn Ltd.
Navan Business Park
Dublin Road
Navan, County Meath, Republic of Ireland
Tel.: [phone] • Fax: [phone]

Australia AS/NZS 3200.1

3-14

Guidance and Manufacturer’s Declaration

The REF 73211 and its powering accessories is intended for use in the electromagnetic environment specified

below. The customer or user of the REF 73211 and its powering accessories should assure that it is used in

such an environment.

Emissions Test Compliance Electromagnetic Environment - Guidance

Emissions for all EQUIPMENT and SYSTEMS

RF Emissions
CISPR 11

RF Emissions
CISPR 11

Harmonics
IEC 61000-3-2

Flicker
IEC 31000-3-3

Group 1 The REF 73211 and its powering accessories uses RF

Class B The REF 73211 and its powering accessories is suitable for

Class A

Complies

energy for its internal function. Therefore, its RF emissions
are very low and are not likely to cause interference in
nearby electronic equipment.

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.

3-15

The REF 73211 is intended for use in the electromagnetic environment specified below. The customer or user

of the REF 73211 should assure that it is used in such an environment.

Electromagnetic Immunity for all EQUIPMENT and SYSTEMS

Immunity Test IEC 60601

Test Level

ESD
IEC 61000-4-2

EFT
IEC 61000-4-4

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

Note 1: The REF 73211 and its power accessories are a simple power supply and a lamp. The only EMC test
events that could affect the performance or environment of the system are Harmonics, Flicker, Radiated and
Conducted Emission, Surge Immunity, and Voltage Dips, ESD, Radiated RFI, EFT, Conducted RFI, and Power
Frequency Magnetic Immunity should not affect the performance of this product; at the levels required in
EN60601-1-2:2001.

± 6kV Contact
± 8kV Air

±2kV Mains
±1kV I/Os

±1kV Differential
±2kV Common

>95% Dip for 0.5 Cycle

for 5 Cycles

60% Dip

30% Dip for 25 Cycles

>95% Dip for 5
Seconds

3 A/m Not Applicable,

Compliance

Level

Not Applicable,
See Note 1

Not Applicable,
See Note 1

±1kV Differential
Not Applicable

During each dip in
the mains voltage
the light will
flicker. During the
5-Second dropout,
the light shuts off,
but returns when
mains power is
restored. See
guidance at the
right.

See Note 1

Electromagnetic

Environment - Guidance

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

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.

Mains power quality should be
that of a typical commercial or
hospital environment. If the user
of the REF 73211 and its
powering accessories requires
that the light remain on during
the power outage, the system
must be powered from an
uninterruptible power supply or a
battery.

Power frequency magnetic fields
should be at levels characteristic
of a typical location in a typical
commercial or hospital
environment.

3-16

The REF 73211 and its powering accessories is intended for use in the electromagnetic environment

d

3.5

E

1

-------





P=

80 MHz to 800 MHz

d

3.5

V

1

-------





P=

d

7

E

1

------ -





P=

800 Mhz to 2.5 GHz

specified below. The customer or user of the REF 73211 and its powering accessories should assure that it is

Guidance and Manufacturer’s Declaration - Emissions

used in such an environment.

Immunity Test IEC 60601

Test Level

Conducted RF
IEC 61000-4-6

Radiated RF
IEC 61000-4-3

3 Vrms
150 kHz to 80MHz
(outside ISM bands)

3 V/m
80 MHz to 2.5 GHz

Compliance

Level

Not Applicable,
See Note 1

Not Applicable,
See Note 1

Electromagnetic

Environment - Guidance

Portable and mobile RF
communications equipment
should be used no closer to
any part of the REF 73211 and
its powering accessories,
including cables, than the
recommended separation
distances calculated below:

Where P is the max power in
watts and d is the
recommended separation
distance in meters.

Field strengths from fixed
transmitters, as determined
by an electromagnetic site
survey, should be less than
the compliance levels (V1 and
E1). Interference may occur in
the vicinity of equipment
containing a transmitter.

Note 1: The REF 73211 and its power accessories are a simple power supply and a lamp. The only EMC test
events that could affect the performance or environment of the system are Harmonics, Flicker, Radiated and
Conducted Emission, Surge Immunity, and Voltage Dips, ESD, Radiated RFI, EFT, Conducted RFI, and Power
Frequency Magnetic Immunity should not affect the performance of this product; at the levels required in
EN60601-1-2:2001.

3-17

Recommended Separations Distances between portable and mobile RF

d

3.5

V

1

-------





P=

d

3.5

E

1

-------





P=

d

7

E

1

------ -





P=

Communications equipment and the REF 73211 and its powering accessories

The REF 73211 and its powering accessories is intended for use in the electromagnetic environment in

which radiated disturbances are controlled. The customer or user of the REF 73211 and its powering

accessories can help prevent electromagnetic interference by maintaining a minimum distance

between portable and mobile RF Communications Equipment (transmitters) and the REF 73211 and its

powering accessories as recommended below, according to the maximum output power of the

communications equipment.

Max
Output
Power
(Watts)

0.01 Not Applicable Not Applicable Not Applicable

0.1 Not Applicable Not Applicable Not Applicable

1 Not Applicable Not Applicable Not Applicable

10 Not Applicable Not Applicable Not Applicable

100 Not Applicable Not Applicable Not Applicable

Separation (m)

150kHz to 80MHz

Separation (m)

80 to 800MHz

Separation (m)

800MHz to 2.5GHz

3-18

Guía para la solución de problemas

Problema Posible causa Solución

La lámpara para examen
rectal no está enchufada
en la fuente de
alimentación.

La fuente de
alimentación no está
enchufada.

La lámpara no
se enciende.

La lámpara para
examen rectal
no permanece
enchufada en el
cable del
transformador.

Luz poco
intensa.

Esta guía está indicada para ofrecer asistencia en la determinación de
condiciones de fallo de este producto. Por favor, póngase en contacto con el
centro de servicio técnico de Welch Allyn indicado en el manual de propietarios
del producto para obtener asistencia adicional.

Bombilla defectuosa

Bombilla floja

Bombilla equivocada

Bombilla dañada

El enchufe de
interconexión del
transformador y la
lámpara para examen
rectal está dañado.

Bombilla defectuosa

Las lentes de la lámpara
están sucias

Compruebe que la lámpara para
examen rectal está correctamente
enchufada en el cable de
alimentación.

Compruebe que la fuente de
alimentación está correctamente
enchufada en la toma de corriente.

Sustitúyala por una bombilla
nueva.

Compruebe que la bombilla está
bien asegurada a la lámpara para
examen rectal.

Compruebe que la bombilla es
Welch Allyn REF 07800.

Inspeccione la bombilla y la junta
para ver si presentan daños. Si
está dañada, sustitúyala por una
bombilla REF 07800.

Inspeccione el enchufe de
interconexión para ver si presenta
daños. Sustituya uno o ambos con
la REF 73211 o REF 73305, 73322,
73324, 73326.

Sustitúyala por una bombilla
nueva.

Inspeccione las lentes de la
lámpara para ver si tienen residuos
y están limpias.

3-19

Guía para la solución de problemas: Personal calificado
exclusivamente

Problema Posible causa Solución

No entra corriente en la
toma de corriente
eléctrica.

Fuente de alimentación
defectuosa.

La lámpara no
se enciende.

Lámpara para examen
rectal defectuosa.

Luz poco
intensa.

Esta guía está indicada para ofrecer asistencia en la determinación de
condiciones de fallo de este producto. Por favor, póngase en contacto con el
centro de servicio técnico de Welch Allyn indicado en el manual de propietarios
del producto para obtener asistencia adicional.

Voltaje inadecuado
suministrado al
transformador.

Compruebe que entra corriente en
la toma de corriente eléctrica.

Compruebe el voltaje suministrado
a través de la fuente de
alimentación en el extremo del
cable. Compruebe que la lectura
de voltaje es de aproximadamente
6,0 voltios (REF 73305, 73322,
73324, 73326). Esta prueba
solamente debe ser realizada por
personal debidamente entrenado.

Compruebe que la lámpara para
examen rectal está defectuosa
cambiándola por una lámpara
nueva para examen rectal o
mientras pasa electricidad a través
del transformador (anterior), retire
la bombilla y mida el voltaje entre
el contacto central del casquillo de
la bombilla y las roscas del
casquillo. Compruebe que la
lectura de voltaje es de
aproximadamente 6,0 voltios (CC
con REF 73305, 73322, 73324,

73326). Esta prueba solamente
debe ser realizada por personal
debidamente entrenado.

Compruebe que el voltaje
suministrado a la toma de
corriente del transformador
cumple los requisitos indicados en
este manual.

3-20

Garantía y servicio técnico

Garantía limitada

Se garantiza que los instrumentos nuevos comprados de Welch Allyn,
Inc. (Welch Allyn) no tienen ningún defecto original en sus materiales o
fabricación bajo condiciones de uso y servicio normales durante un
período de un año para la lámpara para examen rectal Welch Allyn
(REF 73211) y la fuente de alimentación (REF 73305, 73322, 73324,

73326) desde la fecha del primer envío de Welch Allyn. Está garantía será
cumplida por Welch Allyn o su representante autorizado para reparar o
reemplazar, según el criterio de Welch Allyn, cualquier defecto, sin costo
alguno por las piezas y la mano de obra.

Welch Allyn debe ser notificado por vía telefónica de cualquier producto
defectuoso y el artículo debe devolverse inmediatamente a Welch Allyn,
con un número de Notificación de Servicio Técnico suministrado por Welch
Allyn, embalado correctamente y con los gastos postales prepagados. El
comprador asumirá cualquier pérdida o daño durante el envío.

Welch Allyn no será responsable de pérdidas asociadas con el uso de
cualquier producto Welch Allyn que (1) tenga un número de serie
desfigurado, (2) haya sido reparado por cualquier otra persona que no sea
representante del servicio técnico autorizado de Welch Allyn, (3) haya sido
alterado, (4) se haya usado sin seguir las instrucciones o (5) haya sido
sometido a abuso o expuesto a condiciones medioambientales extremas.

ESTA GARANTÍA ES EXCLUSIVA Y SUSTITUYE CUALQUIER GARANTÍA
IMPLÍCITA O DE COMERCIALIZACIÓN, APTITUD PARA UN FIN
ESPECÍFICO U OTRAS GARANTÍAS DE CALIDAD, EXPRESAS O
IMPLÍCITAS. WELCH ALLYN NO SERÁ RESPONSABLE DE NINGÚN
DAÑO INCIDENTAL O INDIRECTO DERIVADO DE LA VENTA, USO O
FUNCIONAMIENTO INADECUADO DEL INSTRUMENTO SEA CUAL SEA
LA CAUSA. LOS DAÑOS POR LOS QUE WELCH ALLYN SERÁ
RESPONSABLE INCLUYEN, ENTRE OTROS, PÉRDIDA DE INGRESOS O
BENEFICIOS, GASTOS POR TIEMPO DE INACTIVIDAD Y PÉRDIDA DE
USO DEL INSTRUMENTO.

3-21

Asistencia técnica

Si encuentra un problema en el equipo que no puede resolver, llame al
centro de servicio técnico Welch Allyn más cercano a usted para obtener
asistencia. El servicio de asistencia técnica está disponible por teléfono
los días laborables normales en los números de teléfono indicados en
Centros de servicio técnico de Welch Allyn.

Antes de ponerse en contacto con Welch Allyn o su centro de servicio
técnico, consulte las siguientes áreas del iluminador y del transformador
para identificar la fecha de fabricación del componente o los
componentes.

• Lámpara para examen rectal: Cuatro dígitos, mes, año, impreso al lado
de la etiqueta REF 73211 en el manguito de la lámpara para examen
rectal.

• Fuente de alimentación: Cuatro dígitos, semana, año impresos o en una
etiqueta situada en el lado en punta del enchufe del transformador.

Si se le ha aconsejado que devuelva un producto a Welch Allyn para su
mantenimiento o reparación, debe concertar la reparación con el centro
de servicio Welch Allyn más cercano a usted.

Antes de devolver un producto para su reparación, debe obtener primero
una autorización de Welch Allyn. Nuestro personal del servicio técnico le
proporcionará un número de “notificación de servicio técnico”. Asegúrese
que anota este número en la parte externa de su caja de envío. Las
devoluciones sin un número de “notificación de servicio técnico” no
serán aceptadas. Antes de enviar, limpie y desinfecte los componentes
como se ha indicado en este manual.

3-22

Centros de servicio técnico de Welch Allyn

Para obtener información acerca de cualquier producto de Welch Allyn,
comuníquese con el servicio técnico de Welch Allyn.

Estados Unidos [phone]

[phone]

Canadá [phone] China [phone]

Centro de llamadas en Europa [phone] Francia [phone]

Alemania [phone] Japón [phone]

América Latina [phone] Países Bajos [phone]

Singapur [phone] Sudáfrica [phone]

Reino Unido [phone] Suecia [phone]

Australia [phone]

[phone]

3-23

3-24

Índice

Descrições dos símbolos . . . . . . . . . . . . . . . . . . . . . 4-3

Advertências e avisos . . . . . . . . . . . . . . . . . . . . . . . . 4-3

Instruções de uso . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-6

Ref. 73305, 73322, 73324, 73326 (fontes de força) . . . 4-6

Pistola retal iluminada ref. 73211 . . . . . . . . . . . . . . . . . 4-8

Manutenção . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-11

Manutenção preventiva . . . . . . . . . . . . . . . . . . . . . . . . 4-11

Substituição da lâmpada . . . . . . . . . . . . . . . . . . . . . . . 4-11

Limpeza . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-12

Descarte . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-14

Especificações . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-15

Aprovações . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-16

Guidance and Manufacturer’s Declaration . . . . . . . . . 4-17

Guia de Solução de Problemas . . . . . . . . . . . . . . . . 4-21

Guia de solução de problemas - somente profissionais

qualificados . . . . . . . . . . . . . . . . . . . . . . . 4-22

Garantia e Manutenção . . . . . . . . . . . . . . . . . . . . . 4-23

Garantia limitada . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-23

Assistência Técnica . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-24

Centros de Serviços da Welch Allyn . . . . . . . . . . . . . . 4-25

Obrigado por adquirir a pistola de luz retal ref. 73211 e/ou a fonte de força
ref. 73305, 73322, 73324, 73326 da Welch Allyn. Analise este manual
antes de usar o sistema.

Somente médicos adequadamente treinados para exames do tipo
endoscópico devem usar a pistola retal iluminada e sua fonte de força
correta, combinadas aos dispositivos da Welch Allyn listados na tabela da
página 4-8.

A pistola retal iluminada 73211 foi desenvolvida para ser conectada
somente à fonte de força correta, com a tensão regional e o estilo de
tomada apropriados e listados neste manual. Nenhum outro uso destes
produtos é previsto ou recomendado. Siga as orientações fornecidas
neste manual, para a conexão e utilização adequadas da pistola retal
iluminada.

Classificação

Classe II, peça aplicada do tipo BF, equipamento comum

Funcionamento intermitente

Descrições dos símbolos

Atenção, advertência, aviso:
ver instruções de uso.

Aviso: temperaturas elevadas - - -

Aviso: luz de alta intensidade Corrente alternada

Isolamento duplo IPXØ

Advertências e avisos

ADVERTÊNCIA: Para evitar lesão ocular, não olhe diretamente para o
raio de luz.

4-1

Peça aplicada do tipo BF

Corrente direta

Não é protegido contra a
entrada da água.

ADVERTÊNCIA: A lâmpada é prejudicial à pele, se tocada enquanto
estiver quente. Espere no mínimo 5 minutos pelo esfriamento da
lâmpada, antes de substituí-la.

ADVERTÊNCIA: A pistola retal iluminada e a fonte de força não são
adequadas para o uso na presença de uma mistura anestésica inflamável
com ar, oxigênio ou óxido nitroso. Isso pode resultar em explosão.

ADVERTÊNCIA: A lâmpada produz calor e deve permanecer desligada
até imediatamente antes e exatamente após o uso. Não coloque a
pistola retal iluminada sobre uma superfície inflamável, se a lâmpada
estiver acesa ou quente.

ADVERTÊNCIA: Desconecte a fonte de força da tomada, antes de
qualquer tipo de manutenção.

ADVERTÊNCIA: Utilize somente as fontes de força de 6V, descritas
neste manual, com a pistola retal iluminada 73211. A inobservância a
esta advertência pode causar danos à fonte de força e/ou ao dispositivo
não-aprovado.

ADVERTÊNCIA: O uso de acessórios, transdutores e/ou cabos
diferentes dos especificados, com a exceção daqueles vendidos pelo
fabricante como peças sobressalentes para componentes internos,
pode resultar no aumento das emissões ou na redução da imunidade do
equipamento ou sistema.

AVISO: As leis federais (EUA) exigem que este dispositivo seja vendido
por médicos ou mediante receita médica.

AVISO: A luz emitida pela pistola retal iluminada é intensa.
AVISO: Este acessório endoscópico destina-se apenas ao uso com os

dispositivos da Welch Allyn listados na tabela da página 4-8. Não utilize o
iluminador de nenhuma outra maneira.

AVISO: Utilize somente os métodos de limpeza descritos neste manual.
AVISO: No interior do dispositivo, com a exceção da lâmpada, não há

peças passíveis de manutenção pelo usuário. Entre em contato com o
Centro de Manutenção listado na página 4-23 em caso de problemas
referentes à manutenção.

AVISO: A pistola retal iluminada 73211 foi desenvolvida para ser
conectada somente à fonte de força correta, com a tensão regional e o
estilo de tomada apropriados e listados neste manual. Nenhum outro
uso destes produtos é previsto ou recomendado.

AVISO: Equipamentos médicos elétricos precisam de precauções
especiais no que diz respeito à CEM (condutividade eletromagnética) e
devem ser instalados e colocados em operação de acordo com as
informações de CEM iniciadas na página 4-15.

AVISO: Equipamentos portáteis e móveis de comunicações por RF
podem afetar os equipamentos médicos elétricos.

4-3

Instruções de uso

A energia da fonte de força (ref. 73305, 73322, 73324, 73326) é fornecida, a partir
de uma tomada de parede adequada, para a pistola retal iluminada (ref. 73211),
que abriga a lâmpada (REF 07800). A pistola retal iluminada e a sua fonte de força
adequada fornecem um sistema de iluminação cuja utilização é prevista com os
dispositivos e/ou acessórios da Welch Allyn (consulte a tabela na página 4-8).

Ref. 73305, 73322, 73324, 73326 (fontes de força)

Verifique se a fonte de força está firmemente conectada à tomada adequada e
se a energia fornecida à tomada está dentro da faixa especificada na tabela.

Corrente de

entrada na

tensão de

entrada nom.

(mA)

Faixa da tensão

de entrada (V.)

Estilo do

plugue

REF

Te ns ão de

entrada nom.

73305 120V 60 Hz 71 110 - 130
73322 230V 50 Hz 30 210 - 230
73324 240V 50 Hz 27 230 - 250
73326 234V 50 Hz 27 230 - 250

A

B

C

D

4-4

Tipo de tomada

A B C D

EUA

NEMA 1-15P

EUROPA

CEE 7/16

REINO
UNIDO

BS 1363

AUSTRÁLIA /
NOVA ZELÂNDIA

AS 3112

Conecte a fonte de força ao soquete com a
tensão e a configuração de plugue adequadas.

Após a conexão correta, é aceso o LED verde
localizado na caixa da fonte de força, indicando
que há energia presente no cabo.

4-5

Pistola retal iluminada ref. 73211

Série da ref. 73305 (ilustrada)
Ref. 73322
Ref. 73324
Ref. 73326

Ref. 73211

Ref. 38700

Ref. 36019

Série da ref. 38/39

Série da ref. 37

Ref. 53110

Série da ref. 32

Ref. 53130

Encaixe a pistola retal iluminada 73211 no dispositivo apropriado,
selecionado na tabela da página 4-8.

4-6

Como montar/desmontar o sistema da pistola retal iluminada:

Porta de entrada

73211

1. Selecione o dispositivo apropriado na tabela da página 4-8.

2. Insira a pistola retal iluminada 73211 acima da “porta de entrada”
retangular do dispositivo, enquanto gira o botão do 73211 na direção
da opção “liberar”, conforme ilustrado. Solte o botão e verifique se a
pistola retal iluminada 73211 está firmemente conectada ao
dispositivo.

3. Conecte a fonte de força ref. 73305, 73322, 73324 ou 73326 à
tomada adequada.

4. Alinhe o plugue localizado na extremidade do cabo da pistola retal
iluminada com o conector na extremidade da fonte de força e
encaixe-o. A lâmpada da 73211 acende automaticamente.

5. Para desligar a lâmpada, desconecte a pistola retal iluminada da fonte
de força.

6. Para remover o dispositivo da pistola retal iluminada, gire o botão da
73211 na direção da opção “liberar” e retire a 73211 da porta de
entrada do dispositivo.

4-7

A pistola retal iluminada (ref. 73211) e a fonte de força (ref. 73305, 73322,
73324, 73326) foram desenvolvidas para a operação com os seguintes
dispositivos da Welch Allyn para procedimentos endoscópicos:

Pistola retal 73211 da Welch Allyn

Série 32 Série 38/39 equipada com o 38700

Sigm. pediátrico de f.o. de 11mm x

32 010

10c m

Sigm. de f.o. para estritura de 11mm x

32020

25cm

Sigm. pediátrico de f.o. de 15mm x

32410

15cm

32420 Sigm. de f.o. de 15mm x 25cm 38122 Espéc. ano. padrão de 22mm x 89mm

32810 Sigm. padrão de f.o. de 19mm x 15cm 38900 Espéc. ano. rotatório de 20mm x 68mm

32820 Sigm. padrão de f.o. de 19mm x 25cm 38614

33830 Sigm. padrão de f.o. de 19mm x 30cm 38619

32830 Sigm. padrão de f.o. de 10mm x 35cm 38622

33220 Sigm. padrão de f.o. de 23mm x 25cm 39614 Espéc. ano. longo de 14mm x 127mm

33620 Sigm. padrão de f.o. de 27mm x 25cm 39619 Espéc. ano. longo de 19mm x 127mm

38108 Espéc. ano. padrão de 8 mm x 89mm

38114 Espéc. ano. padrão de 14mm x 89mm

38119 Espéc. ano. padrão de 19mm x 89mm

Espéc. ano. operatório de 14mm x
89mm

Espéc. ano. operatório de 19mm x
89mm

Espéc. ano. operatório de 22mm x
89mm

Série 37

37019 Anoscópio de f.o. de 19mm x 7cm

37023 Anoscópio de f.o. de 23mm x 7cm 53130

37027 Anoscópio de f.o. de 27mm x 7cm 53110 Anoscópio descartável

39622 Espéc. ano. longo de 22mm x 127mm

Descartáveis equipados com o 36019

Sigm. descartável KleenSpec de
19mm x 25cm

4-8

Manutenção

SH

SAH

Anel O-ring

Lâmpada – ref. 07800

Bucha da pistola retal iluminada

Manutenção preventiva

Examine mensalmente os cabos, conexões e estojo do transformador
quanto ao desgaste e a danos.

Após cada utilização, limpe a pistola retal iluminada segundo a Seção de
Limpeza deste manual.

Substituição da lâmpada

OBSERVAÇÃO: A lâmpada da pistola retal iluminada (ref. 73211) é a
única peça passível de manutenção pelo usuário. Consulte a figura acima
a fim de obter um auxílio visual para a substituição da lâmpada.

1. Desconecte da tomada da fonte de força do sistema e então desconecte a
pistola retal iluminada do cabo da fonte de força. Espere no mínimo 5
minutos pelo esfriamento da lâmpada.

2. Gire no sentido anti-horário (SAH) a bucha externa da pistola retal
iluminada, para expor a lâmpada (conforme a ilustração).

3. Gire a lâmpada no SAH, removendo-a do corpo da pistola retal
iluminada.

4. Examine o soquete da lâmpada da pistola retal iluminada, quanto a
danos ou irregularidades. Entre em contato com o Centro de
Manutenção listado na página 4-23 em caso de problemas referentes
à manutenção.

5. Ao usar uma nova lâmpada da Welch Allyn, verifique se o número de
ref. é o 97800 e se o anel o-ring está presente e em boas condições.

6. Rosqueie a lâmpada no sentido horário (SH) inserindo-a na pistola
retal iluminada e aperte o suficiente para comprimir o anel o-ring.

4-9

7. Rosqueie no SH a bucha na pistola retal iluminada e aperte o
suficiente para fixá-la.

8. Conecte a fonte de força à tomada de parede apropriada e reconecte
o cabo da pistola retal iluminada ao cabo da fonte de força; verifique
se a lâmpada está acesa.

9. Se a lâmpada não acender, consulte a seção de Solução de Problemas
na página 4-19 ou entre em contato com o Centro de Serviços local
(página 4-23) para obter assistência.

Limpeza

Números de peça 73210 e 73211

(incluindo a lâmpada 07800-U)

Número de peça 73500

(incluindo a lâmpada 03100-U)

AVI SO Deixar a lâmpada arrefecer no mínimo durante 5 minutos,
antes de manuseá-la.

NOTA Deixar a lâmpada instalada durante o reprocessamento de
73210, 73211 e 73500.

Instruções de montagem e desmontagem para o 73210 e 73211

1. Desligar o punho de luz do cabo de alimentação e do dispositivo.

2. Desapertar o casquilho exterior do manípulo, rodando-o no sentido
contrário ao dos ponteiros do relógio.

4-10

3. Seguir um dos métodos de reprocessamento indicados em baixo.

Sentido dos
ponteiros do relógio

Sentido contrário ao dos
ponteiros do relógio

Casquilho exterior do
manípulo de luz rectal

Corpo e cabo do manípulo de
luz rectal

4. Depois de realizar um procedimento de reprocessamento, limpar a
lâmpada com um pano macio, seco e sem pêlos.

5. Voltar a fixar o casquilho limpo ao manípulo, enroscando-o no sentido
dos ponteiros do relógio.

6. Voltar a ligar o cabo de alimentação ao manípulo de luz e verificar se a
unidade funciona ligando-a à corrente. Se a lâmpada não acender,
seguir as instruções de detecção e resolução de problemas no
manual do manípulo de luz ( 700791) fornecido com o mesmo.

Limpeza (73210, 73211 e 73500)

1. Preparar um detergente enzimático formulado para instrumentos
endoscópicos de acordo com as instruções do fabricante. Estas
instruções foram validadas utilizando ENZOL/CIDEZYME.

2. Mergulhar a peça na solução de limpeza.

3. Utilizando uma escova de cerdas suaves, esfregar a peça mergulhada
na solução de limpeza durante um mínimo de 5 minutos. Em
seguida, enxaguar com água esterilizada durante 5 minutos.

Desinfecção de nível intermédio (73210, 73211 e 73500)

1. Seguir as instruções de limpeza indicadas em cima.

2. Utilizando CaviWipes
las molhadas com solução CaviWipes durante um mínimo de 5
minutos.

3. Permitir que as superfícies da peça sequem durante um mínimo de
10 minutos.

™

, limpar todas as superfícies da peça e mantê-

4-11

Esterilização (APENAS 73211)

Precaução O autoclave do manípulo de luz pode reduzir a vida
funcional do produto.

1. Seguir as instruções de limpeza indicadas em cima.

2. Realizar um ciclo de autoclave que inclua 6 minutos a 132° C e um
período de arrefecimento de, pelo menos, 15 minutos. Estas
instruções foram validadas com um autoclave por gravidade. Validar
qualquer outro equipamento de esterilização e carregar as
configurações.

Descarte

Não existem materiais nocivos associados ao sistema da pistola retal
iluminada.

Não existem riscos associados ao descarte deste dispositivo após sua
vida útil, se ele for limpo de acordo com as instruções contidas neste
manual.

4-12

Especificações

Classificação: Classe II, peça aplicada do tipo BF

Entrada: 100 a 240V , 50/60 Hz, 200 mA

Saída: 6.0V , 1150 mA

Categoria: Não é um equipamento AP/APG

Especificações físicas:

Pistola retal iluminada: 96mm (3,775") x 25mm (1,00"), 104 g (3,67 oz)
Fonte de força: 43mm (1,71") C x 52mm (2,06") L x 55mm (2.18") A
Cabo da fonte de força: 183 cm (71,4")

Iluminação:

Vida útil da lâmpada: 75 horas
Tensão da lâmpada: 6 V
Lâmpada: Welch Allyn ref. 07800

Classificação IPX: IPXØ

Ambiente

Operacional: +10° C a + 35° C (50° F a 95° F), 95% de umidade relativa (UR)

500 hPa a 1060 hPa

Transporte/armazenamento: -20° C a +49° C (-2° F a 120° F), 95% de UR

500 hPa a 1060 hPa

Funcionamento intermitente
Pistola retal iluminada10 min. ligado no máx.; 5 min. desligado no mín.

4-13

Aprovações

74227

US

74227

L

I

S

T

E

D

L

I

S

T

E

D

C

CM

I

N

T

E

R

T

E

K

EC REP

N344

CERTIFICADO PARA: CAN/CSA STD C22.2 Nº 601.1

ATENDE A: EN/IEC 60601-1, UL 60601-1, EN/
IEC 60601-1-2, EN/IEC 60601-2-18

A marca CE indica que este produto foi testado e
encontra-se em conformidade com as provisões
dispostas na diretiva de aparelhos médicos 93/42/EEC.

European Regulatory Manager

European Regulatory Manager
Welch Allyn Ltd.
Navan Business Park
Dublin Road
Navan, County Meath, Republic of Ireland
Tel.: [phone] • Fax: [phone]

Austrália AS/NZS 3200.1

4-14

Guidance and Manufacturer’s Declaration

The REF 73211 and its powering accessories is intended for use in the electromagnetic environment specified

below. The customer or user of the REF 73211 and its powering accessories should assure that it is used in

such an environment.

Emissions Test Compliance Electromagnetic Environment - Guidance

Emissions for all EQUIPMENT and SYSTEMS

RF Emissions
CISPR 11

RF Emissions
CISPR 11

Harmonics
IEC 61000-3-2

Flicker
IEC 31000-3-3

Group 1 The REF 73211 and its powering accessories uses RF

Class B The REF 73211 and its powering accessories is suitable for

Class A

Complies

energy for its internal function. Therefore, its RF emissions
are very low and are not likely to cause interference in
nearby electronic equipment.

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.

4-15

The REF 73211 is intended for use in the electromagnetic environment specified below. The customer or user

of the REF 73211 should assure that it is used in such an environment.

Electromagnetic Immunity for all EQUIPMENT and SYSTEMS

Immunity Test IEC 60601

Test Level

ESD
IEC 61000-4-2

EFT
IEC 61000-4-4

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

Note 1: The REF 73211 and its power accessories are a simple power supply and a lamp. The only EMC test
events that could affect the performance or environment of the system are Harmonics, Flicker, Radiated and
Conducted Emission, Surge Immunity, and Voltage Dips, ESD, Radiated RFI, EFT, Conducted RFI, and Power
Frequency Magnetic Immunity should not affect the performance of this product; at the levels required in
EN60601-1-2:2001.

± 6kV Contact
± 8kV Air

±2kV Mains
±1kV I/Os

±1kV Differential
±2kV Common

>95% Dip for 0.5 Cycle

for 5 Cycles

60% Dip

30% Dip for 25 Cycles

>95% Dip for 5
Seconds

3 A/m Not Applicable,

Compliance

Level

Not Applicable,
See Note 1

Not Applicable,
See Note 1

±1kV Differential
Not Applicable

During each dip in
the mains voltage
the light will
flicker. During the
5-Second dropout,
the light shuts off,
but returns when
mains power is
restored. See
guidance at the
right.

See Note 1

Electromagnetic

Environment - Guidance

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

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.

Mains power quality should be
that of a typical commercial or
hospital environment. If the user
of the REF 73211 and its
powering accessories requires
that the light remain on during
the power outage, the system
must be powered from an
uninterruptible power supply or a
battery.

Power frequency magnetic fields
should be at levels characteristic
of a typical location in a typical
commercial or hospital
environment.

4-16

The REF 73211 and its powering accessories is intended for use in the electromagnetic environment

d

3.5

E

1

-------





P=

80 MHz to 800 MHz

d

3.5

V

1

-------





P=

d

7

E

1

------ -





P=

800 Mhz to 2.5 GHz

specified below. The customer or user of the REF 73211 and its powering accessories should assure that it is

Guidance and Manufacturer’s Declaration - Emissions

used in such an environment.

Immunity Test IEC 60601

Test Level

Conducted RF
IEC 61000-4-6

Radiated RF
IEC 61000-4-3

3 Vrms
150 kHz to 80MHz
(outside ISM bands)

3 V/m
80 MHz to 2.5 GHz

Compliance

Level

Not Applicable,
See Note 1

Not Applicable,
See Note 1

Electromagnetic

Environment - Guidance

Portable and mobile RF
communications equipment
should be used no closer to
any part of the REF 73211 and
its powering accessories,
including cables, than the
recommended separation
distances calculated below:

Where P is the max power in
watts and d is the
recommended separation
distance in meters.

Field strengths from fixed
transmitters, as determined
by an electromagnetic site
survey, should be less than
the compliance levels (V1 and
E1). Interference may occur in
the vicinity of equipment
containing a transmitter.

Note 1: The REF 73211 and its power accessories are a simple power supply and a lamp. The only EMC test
events that could affect the performance or environment of the system are Harmonics, Flicker, Radiated and
Conducted Emission, Surge Immunity, and Voltage Dips, ESD, Radiated RFI, EFT, Conducted RFI, and Power
Frequency Magnetic Immunity should not affect the performance of this product; at the levels required in
EN60601-1-2:2001.

4-17

Recommended Separations Distances between portable and mobile RF

d

3.5

V

1

-------





P=

d

3.5

E

1

-------





P=

d

7

E

1

------ -





P=

Communications equipment and the REF 73211 and its powering accessories

The REF 73211 and its powering accessories is intended for use in the electromagnetic environment in

which radiated disturbances are controlled. The customer or user of the REF 73211 and its powering

accessories can help prevent electromagnetic interference by maintaining a minimum distance

between portable and mobile RF Communications Equipment (transmitters) and the REF 73211 and its

powering accessories as recommended below, according to the maximum output power of the

communications equipment.

Max
Output
Power
(Watts)

0.01 Not Applicable Not Applicable Not Applicable

0.1 Not Applicable Not Applicable Not Applicable

1 Not Applicable Not Applicable Not Applicable

10 Not Applicable Not Applicable Not Applicable

100 Not Applicable Not Applicable Not Applicable

Separation (m)

150kHz to 80MHz

Separation (m)

80 to 800MHz

Separation (m)

800MHz to 2.5GHz

4-18

Guia de Solução de Problemas

Problema Possível Causa Solução

A pistola retal iluminada
não está conectada à
fonte de força.

A fonte de força não está
conectada.

A lâmpada não
acende.

A pistola retal
iluminada não
permanece
conectada ao
cabo do
transformador.

A luz gerada
parece fraca.

Este guia foi desenvolvido a fim de fornecer assistência na determinação das
condições defeituosas deste produto. Entre em contato com o Centro de
Serviços autorizado da Welch Allyn, listado nos manuais do proprietário do
produto, para obter assistência adicional.

Lâmpada defeituosa Substitua por uma nova lâmpada.

Lâmpada solta

Lâmpada errada

Lâmpada danificada

O plugue de interconexão
entre a pistola ao retal
iluminada e o
transformador está
danificado.

Lâmpada defeituosa Substitua por uma nova lâmpada.
A lente da lâmpada está

suja

Verifique se a pistola retal
iluminada está adequadamente
conectada ao cabo da fonte de
força.

Verifique se a fonte de força está
adequadamente conectada à
tomada.

Verifique se a lâmpada está presa
na pistola retal iluminada.

Verifique se a lâmpada é da Welch
Allyn, com ref. 07800.

Examine a lâmpada e o anel o-ring
quanto a danos. Substitua por uma
lâmpada ref. 07800 se encontrar
danos.

Examine o plugue de interconexão
quanto a danos. Substitua por
outro com a ref. 73211 ou ref.
73305, 73322, 73324, 73326.

Verifique se há detritos na lente da
lâmpada e limpe-a.

4-19

Guia de solução de problemas - somente profissionais
qualificados

Problema Possível Causa Solução

Não há energia na
tomada da fonte de força.

Fonte de força defeituosa.

A lâmpada não
acende.

Pistola retal iluminada
defeituosa.

A luz gerada
parece fraca.

Este guia foi desenvolvido a fim de fornecer assistência na determinação das
condições defeituosas deste produto. Entre em contato com o Centro de
Serviços autorizado da Welch Allyn, listado nos manuais do proprietário do
produto, para obter assistência adicional.

Tensão inadequada
fornecida ao
transformador.

Verifique se a energia está sendo
fornecida à tomada da fonte de
força.

Teste a tensão fornecida através da
fonte de força, na extremidade do
cabo. Verifique se a leitura da
tensão é de aproximadamente 6.0
volts CC (ref. 73305, 73322, 73324,

73326). Somente profissionais
adequadamente treinados devem
realizar este teste.

Verifique se a pistola retal iluminada
está defeituosa, substituindo-a por
uma nova pistola, ou fornecendo
energia através do transformador
(acima): remova a lâmpada e meça a
tensão entre o contato central do
soquete da lâmpada e as roscas do
soquete. Verifique se a leitura da
tensão é de aproximadamente 6.0
volts (CC com a ref. 73305, 73322,
73324, 73326). Somente
profissionais adequadamente
treinados devem realizar este teste.

Verifique se a tensão fornecida à
tomada do transformador atende
aos requisitos citados neste
manual.

4-20

Garantia e Manutenção

Garantia limitada

É garantido que o instrumento adquirido da Welch Allyn, Inc. (Welch
Allyn) esteja livre de defeitos originais de material e manufatura, sob uso
e manutenção normais e por um período de um ano, no caso da Pistola
Retal Iluminada da Welch Allyn (ref. 73211) e a Fonte de Força (ref. 73305,
73322, 73324, 73326) a partir da data do primeiro despacho da Welch
Allyn. Esta garantia deverá ser cumprida pela Welch Allyn ou o seu
representante autorizado, que fará o reparo ou substituição em caso de
qualquer defeito desse tipo, de acordo com o julgamento da Welch Allyn,
livre de encargos referentes a peças ou mão-de-obra.

A Welch Allyn deve ser avisada por telefone da ocorrência de defeito no
produto, o qual deverá ser devolvido imediatamente para a mesma, com
o número de Notificação de Serviço fornecido pela Welch Allyn, em
embalagem segura e porte pago. Perdas ou danos ocorridos no envio
são de responsabilidade do comprador.

A Welch Allyn não se responsabiliza por perdas associadas ao uso de
qualquer produto da Welch Allyn que (1) esteja com o número da data de
manufatura rasurado, (2) tenha sido consertado por alguém que não seja
um Representante de Serviços autorizado da Welch Allyn, (3) tenha sido
alterado, (4) tenha sido usado de uma maneira que não esteja de acordo
com as instruções ou (5) tenha sofrido abuso ou sido exposto a
condições ambientais extremas.

ESTA GARANTIA É EXCLUSIVA E SUBSTITUI QUALQUER GARANTIA
IMPLÍCITA DE COMERCIALIZAÇÃO, ADEQUAÇÃO PARA UM
PROPÓSITO PARTICULAR OU OUTRA GARANTIA DE QUALIDADE,
SEJA EXPRESSA OU IMPLÍCITA. A WELCH ALLYN NÃO SE
RESPONSABILIZA POR NENHUM DANO INCIDENTAL OU
CONSEQÜENCIAL RESULTANTE DA VENDA, UTILIZAÇÃO OU
FUNCIONAMENTO INADEQUADO DO INSTRUMENTO,
INDEPENDENTEMENTE DA CAUSA. OS DANOS PELOS QUAIS A
WELCH ALLYN NÃO SE RESPONSABILIZA INCLUEM, PORÉM NÃO
SÃO LIMITADOS A, PERDA DE LUCROS OU RENDAS, CUSTOS DE
TEMPO PARA MANUTENÇÃO E PERDA DE UTILIZAÇÃO DO
INSTRUMENTO.

4-21

Assistência Técnica

Se não é possível solucionar o problema do seu equipamento, entre em
contato com o Centro de Serviços mais próximo da Welch Allyn para
obter assistência. O suporte técnico está disponível por telefone no
horário comercial, nos números citados na seção de Centros de Serviços
da Welch Allyn.

Antes de entrar em contato com a Welch Allyn ou o seu Centro de
Serviços, localize as seguintes áreas do iluminador e/ou transformador
para identificar a data de fabricação do(s) componente(s).

• Pistola retal iluminada: quatro dígitos, mês seguido pelo ano,
estampados próximo da etiqueta da ref. 73211 na bucha da pistola retal
iluminada.

• Fonte de força: quatro dígitos, semana seguida pelo ano, estampados ou
rotulados no lado das pontas do plugue do transformador.

Se você for aconselhado a devolver o produto para a Welch Allyn para
serviço ou manutenção rotineira, agende o reparo no centro de serviços
mais próximo.

Antes de devolver o produto para o reparo, é necessário obter a
autorização da Welch Allyn. O número de Notificação de Serviço lhe será
fornecido pela nossa equipe de serviços. Anote este número na parte
externa da sua caixa de remessa. As devoluções sem o número de
Notificação de Serviço não serão aceitas. Antes de remeter, por favor limpe
e desinfete o componente de acordo com as instruções deste manual.

4-22

Centros de Serviços da Welch Allyn

Para obter informações sobre qualquer produto Welch Allyn, contactar a
Assistência Técnica da Welch Allyn:

EUA [phone]

[phone]

Canadá [phone] China [phone]

Centro de Atendimento

da Europa
Alemanha [phone] Japão [phone]

América Latina [phone] Países Baixos [phone]

Singapura [phone] África do Sul [phone]

Reino Unido [phone] Suécia [phone]

[phone] França [phone]

Austrália [phone]

[phone]

4-23

4-24