Rectal Light Handle REF 73211 Directions for Use Ver A

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

Type BF Applied Part

---

Caution, high-intensity light Double Insulation

Direct Current Alternating Current

IPXØ

Not protected from the ingress of water.

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.

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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 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

Nom. Input Voltage

Input Current at Nom. Input Voltage (mA)

Input Voltage Range (V.)

Plug Style

73305

120V 60 Hz

71

110 - 130

A

73322

230V 50 Hz

30

210 - 230

B

73324

240V 50 Hz

27

230 - 250

C

73326

234V 50 Hz

27

230 - 250

D

C

D

Outlet Type A

B

USA

EUROPE

UK

NEMA 1-15P

CEE 7/16

BS 1363

AUSTRALIA / NEW ZEALAND AS 3112

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.

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REF 73211 Rectal Light Handle Attach the 73211 Rectal Light Handle to the appropriate device selected from the table on page 1-6. REF 37 Series REF 38/39 Series REF 53130 REF 32 Series

REF 53110

REF 36019

REF 38700 REF 73211

REF 73305 (SHOWN) REF 73322 REF 73324 REF 73326

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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.

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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

39622

22mm x 127mm Long Ano Spec

37 Series

Disposables Fitted with 36019

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

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Maintenance 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 Lamp REF 07800

CCW

CW

O-ring

Rectal Light Handle Sleeve 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.

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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.

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Rectal Light Handle Body and Cord

CCW

CW Rectal Light Handle Outer Sleeve

3.

Follow one of the reprocessing methods described below.

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.

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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.

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Specifications Classification:

Class II, Type BF Applied Part

Input:

100

Output:

6.0V

Category:

Not AP/APG Equipment

Physical Specifications: Rectal Light Handle: Power Supply: Power Supply Cord:

to 240V

, 50/60 Hz, 200 mA

, 1150 mA

96mm (3.775") x 25mm (1.00"), 104 grams (3.67 oz) 43mm (1.71") L x 52mm (2.06") W x 55mm (2.18") H 183 cm (71.4")

Illumination: Lamp Life: Lamp Voltage: Lamp: IPX Rating: Environment Operating: Transport/Storage:

Intermittent Operation Rectal Light Handle

75 hours 6V Welch Allyn REF 07800 IPXØ

+10° C to +35° C (50° F to 95° F), 95% RH 500 hPa to 1060 hPa -20° C to +49° C (-2° F to 120° F), 95% RH, 500 hPa to 1060 hPa

10 minutes on max; 5 minutes off min

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

TERTEK IN CM

C

LI

S T E D US

74 2 2 7 74 2 2 7

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.

EC REP

European Regulatory Manager European Regulatory Manager Welch Allyn Ltd. Navan Business Park Dublin Road Navan, County Meath, Republic of Ireland Tel.: +353 46 90 67700 • Fax: +353 46 90 67756

Australia AS/NZS 3200.1

N344

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Guidance and Manufacturer’s Declaration Emissions for all EQUIPMENT and SYSTEMS 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

RF Emissions CISPR 11

Group 1

The REF 73211 and its powering accessories uses RF energy for its internal function. Therefore, its RF emissions are very low and are not likely to cause interference in nearby electronic equipment.

RF Emissions CISPR 11

Class B

Harmonics IEC 61000-3-2

Class A

The REF 73211 and its powering accessories is suitable for use in all establishments, including domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Flicker IEC 31000-3-3

Complies

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Electromagnetic Immunity for all EQUIPMENT and SYSTEMS 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.

Immunity Test

IEC 60601 Test Level

Compliance Level

Electromagnetic Environment - Guidance

ESD IEC 61000-4-2

± 6kV Contact ± 8kV Air

Not Applicable, See Note 1

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

EFT IEC 61000-4-4

±2kV Mains ±1kV I/Os

Not Applicable, See Note 1

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

Surge IEC 61000-4-5

±1kV Differential ±2kV Common

±1kV Differential Not Applicable

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

Voltage Dips, Short Interruptions, and Voltage Variations on power supply input lines. IEC 61000-4-11

>95% Dip for 0.5 Cycle

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.

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.

Not Applicable, See Note 1

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

60% Dip for 5 Cycles 30% Dip for 25 Cycles >95% Dip for 5 Seconds

Power Frequency 50/60Hz Magnetic Field IEC 61000-4-8

3 A/m

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.

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Guidance and Manufacturer’s Declaration - Emissions 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.

Immunity Test

IEC 60601 Test Level

Compliance Level

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:

Conducted RF IEC 61000-4-6

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

Not Applicable, See Note 1

Radiated RF IEC 61000-4-3

3 V/m 80 MHz to 2.5 GHz

Not Applicable, See Note 1

3.5 d =  ------- P  V 1 3.5 d =  ------- P  E 1 80 MHz to 800 MHz

7 d =  ------- P  E 1 800 Mhz to 2.5 GHz 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.

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Recommended Separations Distances between portable and mobile RF 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.

Separation (m) 150kHz to 80MHz

Separation (m) 80 to 800MHz

Separation (m) 800MHz to 2.5GHz

Max Output Power (Watts)

3.5 d =  ------- P  V 1

3.5 d =  ------- P  E 1

7 d =  ------- P  E 1

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

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Trouble Shooting Guide Problem

Possible Cause

Solution

Rectal Light Handle is not Verify that the Rectal Light Handle plugged into the power is properly plugged into power supply. supply cord.

Lamp does not light.

Power Supply is not plugged in.

Verify the power supply is properly plugged into the outlet.

Faulty Lamp

Replace with a new lamp.

Loose Lamp

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

Wrong Lamp

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

Damaged Lamp

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

Rectal Light Handle does not Rectal Light Handle/ stay plugged transformer interconnect into the plug is damaged. transformer cord. Light output seems low.

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

Faulty Lamp

Replace with a new lamp.

Dirty lamp lens

Inspect lamp lens for debris and clean.

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.

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