Steris Deepsite Fiber Optic Light Operating instructions

Brand: Steris

Model: Deepsite Fiber Optic Light

Type: Operating instructions

Table of Contents Operator Manual P-129380-133

A WORD FROM STERIS CORPORATION

This manual contains important information on proper use and maintenance

of the STERIS® DeepSiteTM Fiber Optic Light. All personnel involved in the

use and maintenance of this equipment must carefully review and

comply with the warnings, cautions, and instructions contained in this

manual. These instructions are important to protect the health and safety of

personnel operating a DeepSite lighting system and should be retained in a

conveniently accessible area for quick reference.

Complete instructions for uncrating and connecting utilities, as well as

equipment drawings, have been furnished. If missing, contact STERIS for

replacement copies, giving the serial number and model numbers of the unit.

STERIS carries a complete line of accessories for use with this lighting system.

A STERIS representative will gladly review these with you.

The STERIS DeepSite Fiber Optic Light is a variable pattern, variable intensity

fiber optic surgical light designed to provide visible illumination of the surgical

field or the patient. The DeepSite consists of a center-mounted suspension;

a flexible "gooseneck" lighthead for ease of positioning; an electronic, wall-

mounted control; and a ceiling-mounted illuminator box. This lighting system

is designed to augment other major surgical luminaries

Indications for Use

A thorough preventive maintenance program is essential to safe and proper

unit operation. This manual contains maintenance schedules and procedures

which should be followed for satisfactory equipment performance.

You are encouraged to contact STERIS concerning our comprehensive

Annual Maintenance Agreements. Under the terms of these agreements,

preventive maintenance, adjustments, and replacement of worn parts are

done on a scheduled basis to assure equipment performance at peak

capability and to help avoid untimely or costly interruptions. STERIS maintains

a global staff of well equipped, factory-trained technicians to provide this

service, as well as expert repair services. Please contact your STERIS

representative for details.

Service Information

A listing of the safety precautions to be observed when operating and

servicing this equipment can be found in Section 1 of this manual. Do not

operate or service the equipment until you have become familiar with this

information.

Any alteration of this equipment not authorized or performed by STERIS

Engineering Service which could affect its operation will void the warranty,

could violate national, state, and local regulations, and could jeopardize your

insurance coverage.

Advisory

P-129380-133 Operator Manual Table of Contents

Manufactured

Exclusively by

STERIS Corporation

Montgomery, AL

ISO 9001

EN 46001

ISO 13485

Certified

The base language of this document is

ENGLISH. Any translations must be

made from the base language document.

STERIS offices worldwide:

Canada 800 661 3937

Germany 49 2233 6999 0

Hong Kong 852 2 563 3623

Italy 39 0141 590429

Japan 81 78 321 2271

Korea 82 2 554 1661

Latin America 305 442 8202

Singapore 65 841 7677

Spain 34 91 658 5920

United Kingdom 44 (0)1256 840400

EC Authorized Representative

STERIS Ltd.

STERIS House

Jays Close

Viables

Basingstoke

Hampshire

RG22 4AX

Tel: +44 (0)1256 840400

Fax: +44 (0) 1256 866502

Manufactured by:

STERIS Corporation

2720 Gunter Park East

Montgomery, AL 36109 • USA

Tel: 334 277 6660

Fax: 334 271 5450

Class 1 Equipment

Type B Equipment

Ordinary Equipment (enclosed equipment without protection of ingress

of water)

Equipment not suitable for use in the presence of a flammable anes-

thetic mixture with air or oxygen or nitrous oxide.

Suitable for continuous operation.

Electrical Specifications: 115/230 Volts AC, 50/60 Hz, 800 Watts

iii

Table of Contents Operator Manual P-129380-133

TABLE OF CONTENTS

Section Title Page

1 LISTING OF WARNINGS AND CAUTIONS ....................................... 1-1

2 COMPONENT IDENTIFICATION....................................................... 2-1

General .............................................................................................................................. 2-1

Wall-mounted Control Panel .............................................................................................. 2-2

Controls ......................................................................................................................... 2-2

Indicators....................................................................................................................... 2-2

Lighthead and Suspension ................................................................................................ 2-4

Ceiling-mounted Illuminator Housing ................................................................................ 2-5

3 OPERATING INSTRUCTIONS .......................................................... 3-1

Wall Control........................................................................................................................ 3-1

Lamp ............................................................................................................................. 3-1

Illumination Intensity ...................................................................................................... 3-1

Check Lamp-Life Indicator ................................................................................................ 3-2

Lighthead Positioning ........................................................................................................ 3-2

Light Pattern Adjustment ............................................................................................... 3-3

Disposable Sterile Sleeve .................................................................................................. 3-4

4 CLEANING THE EQUIPMENT .......................................................... 4-1

General Cleaning/Disinfecting Procedure ......................................................................... 4-1

Cleaning Equipment .......................................................................................................... 4-1

Areas to be Cleaned Before Each Use .............................................................................. 4-2

5 OPERATOR TROUBLESHOOTING ................................................... 5-1

6 ROUTINE MAINTENANCE ............................................................... 6-1

Lamp Change Procedure .................................................................................................. 6-3

7 RECOMMENDED SPARE PARTS ...................................................... 7-1

8 WASTE DISPOSAL GUIDELINES ..................................................... 8-1

P-129380-133 Operator Manual Table of Contents

This Page Intentionally Left Blank

1-1

Listing of Warnings and Cautions Operator Manual P-129380-133

The following is a listing of the safety precautions which must be observed when operating and servicing this equipment.

WARNINGS indicate the potential for danger to personnel, and CAUTIONS indicate the potential for damage to

equipment. These precautions are repeated (in whole or in part), where applicable, throughout the manual.

WARNING – EXPLOSION HAZARD:

Do not use lighting fixture in the presence of flammable anesthetics.

WARNING – ELECTRIC SHOCK AND BURN HAZARD:

Do not remove covers or perform service other than as described in this operator manual. Refer servicing to

qualified service personnel.

WARNING – RISK OF FIRE:

When replacing FUSE (F-1), use only replacement parts as specified in Section 7 of this manual (or as specified

by STERIS Corporation).

WARNING – PERSONAL INJURY HAZARD:

Eye injury may result from exposure to this lamp. Avoid looking directly at high-intensity light, whether at the lamp,

directly at the lighthead, or fiber optic cable.

Do not attempt to adjust suspension system. Refer servicing to qualified service personnel.

Person changing or disposing of the lamp must wear eye protection. Lamp contains xenon gas at high pressure.

Do not attempt to replace lamp unless the power is turned off at the wall control and the lamp module has cooled

sufficiently. Lamp contains xenon gas at high pressure. Persons changing or disposing of the lamp should wear

eye protection.

STERIS does not recommend using the light closer than 15" (381 mm) from the patient.

Read and follow warnings and instructions found on detergent labels and Material Safety Data Sheets.

WARNING – BIOHAZARD:

Sterile sleeve is intended for single use only.

Universal precautions must be observed when disposing of the sterile sleeve.

LISTING OF WARNINGS AND CAUTIONS 1

Listing Continued on Next Page.

1-2

P-129380-133 Operator Manual Listing of Warnings and Cautions

WARNING –PINCHING HAZARD:

Pinch points are created during extreme articulation of the suspension system. Do not place hands on or near

the suspension knuckle during lighthead articulations.

CAUTION –POSSIBLE EQUIPMENT DAMAGE:

Do not bump lighthead into walls or other equipment.

Use only a soft, clean cloth dampened in a solution of mild detergent and water to clean the exterior of this light.

Always follow manufacturer instructions for concentrations and use of cleaning products.

Prevent fluid leakage into the lighting system, do not use excess amounts of fluid during cleaning/disinfecting

procedure.

Do not touch the glass window of the lamp with bare fingers. Skin oils can cause deterioration of material leading

to possible failure of the lamp.

Repairs and adjustments to this equipment should be made only by fully qualified service personnel.

Maintenance performed by inexperienced, unqualified personnel or installation of unauthorized parts could

cause personal injury, invalidate the warranty, or result in costly equipment damage. Contact STERIS

Engineering Service regarding service options.

This device has been tested and found in compliance with IEC 60601-1-2 (1st Edition 1993-04), Medical

Electrical Equipment –Part 1: General Requirements for Safety; Electromagnetic Compatibility (EMC). There is,

however, a potential for electromagnetic or other interference between this equipment and other devices. Should

you experience interference, relocate this device or minimize the use of the affected equipment while this device

is in operation.

1-3

Listing of Warnings and Cautions Operator Manual P-129380-133

Definition of

Symbols Symbol Definition

Power ON

Lamp OFF (Standby)

Lamp ON

Thermal Cutoff Indicator

Intensity ON Indicator

Intensity Increase/Decrease

New Lamp

Lamp Half Used

Change Spent Lamp

Protective Earth (Ground)

Attention, consult manual for further instructions

Hot

SER. NO. Serial Number of Unit

V~ Voltage Rating of Unit, Alternating Current

Listing Continued on Next Page.

1-4

P-129380-133 Operator Manual Listing of Warnings and Cautions

Symbol Definition

A Amperage Rating of Unit

Hz Frequency of Unit

Pinch Point Hazard

Wear Eye Protection

Electric Shock Hazard

Definition of

Symbols

2-1

Component Identification Operator Manual P-129380-133

COMPONENT IDENTIFICATION

Refer to Figure 2-1.

The DeepSite lighting system is made up of three primary components:

1. the wall-mounted control panel,

2. the adjustable lighthead and suspension, and

3. the ceiling-mounted illuminator housing.

General

Figure 2-1. STERIS DeepSite Fiber Optic Surgical Light

LAMP

INTENSITY

LAMP LIFE

SYSTEM

POWER

REPLACE LAMP

Fiber Optic Light

THERMAL

SHUTDOWN

DeepSite

Wall-mounted

Control Panel

NOTE: System circuit

breakers are behind service

access door of ceiling-

mounted illuminator.

Inboard Hub of

Centra Mount

Upper Horizontal

Suspension Arm

Lighthead

Adjustable (lower)

Suspension Arm

WARNING – EXPLOSION

HAZARD: Do not use this

lighting fixture in the pres-

ence of flammable anes-

Suspension

Knuckle

Outboard

Hub

of Centra

Mount

Ceiling-mounted

Illuminator

Adjustable Positioning

Gooseneck

Vertical Suspension

Tube

2-2

P-129380-133 Operator Manual Component Identification

Refer to Figure 2-2.

The wall-mounted control panel should be located at an easily accessible point

on the wall of the operating room.

The controls on the wall panel allow the user to adjust or monitor the

performance characteristics of the DeepSite lighting system. The following

controls are provided:

•Lamp Power On/Off

•Illumination Intensity

The following indicators are provided:

•Lamp Power Status

•System Power Status

•Thermal Shutdown Status

•Intensity Level

•Remaining Lamp-life

Lamp –Press these membrane touch pads to turn the DeepSite lamp on or off.

[symbol] If off, press to turn ON

[symbol] If on, press to turn OFF

Illumination Intensity — This control is used to adjust the illumination level of

the light pattern delivered by the DeepSite lighthead.

Press this membrane touch pad to DECREASE the illumination level.

Press this membrane touch pad to INCREASE the illumination level.

NOTE: The DeepSite illumination level is continuously adjustable between

minimum value and maximum value. LEDs on control panel indicate relative

intensity level.

System Power –When LED is lit, system power is ON.

» Indicators

» Controls

Wall-mounted

Control Panel

WARNING – PERSONAL

INJURY HAZARD: Eye in-

jury may result from expo-

sure to this lamp. Avoid

looking directly at the high-

intensity light, whether at

lamp, directly at the

lighthead, or fiber optic

cable.

Lamp Power –When LED is lit, lamp power is ON.

Thermal Shutdown –If the ceiling illuminator becomes overheated, the

system automatically shuts down. If the system has shut down, this indicator

is illuminated.

IMPORTANT:

If thermal shutdown occurs,

refer to Operator Troubleshooting

(Section 5 of this manual), before continuing to use the light.

Intensity –This indicator shows the relative intensity level of the light pattern.

When the lamp is turned off, this indicator also turns off.

Lamp-life –This indicator shows the approximate remaining lamp-life time.

2-3

Component Identification Operator Manual P-129380-133

Figure 2-2. DeepSite Wall Control

LAMP

INTENSITY

LAMP LIFE

SYSTEM

POWER

REPLACE LAMP

Fiber Optic Light

THERMAL

SHUTDOWN

DeepSiteTM

New Lamp. This symbol indicates that the lamp is new or near the beginning

of its expected use cycle.

This symbol indicates the lamp has reached the approximate

half-way point in its expected use cycle.

This symbol indicates the lamp has reached the end of its expected use cycle.

When this indicator is lit, the lamp should be removed and

replaced with a new one, even if the lamp is still functioning.

Refer to Figure 2-3.

T h e lighthead is supported from a centra mount that allows 360°

Lamp ON/OFF

Control

Illumination

Intensity Controls

System Power

ON/OFF Indicator

Thermal

Shutdown

Indicator

Illumination

Intensity

Indicator

Lamp-life

Indicator

Lamp ON

Indicator

WARNING –PERSONAL

INJURY HAZARD: Eye in-

jury may result from expo-

sure to this lamp. Avoid

looking directly at the high-

intensity light, whether at

lamp, directly at the

lighthead, or fiber optic

cable.

2-4

P-129380-133 Operator Manual Component Identification

rotation around the hub’s center. The upper (horizontal) suspension arm ends

in a second (outboard) hub that allows 340° rotation of the lower suspension

arm and lighthead. The adjustable suspension arm is capable of up and down

articulation. The arm can be positioned up to 15° above horizontal and 90°

below horizontal.

The adjustable suspension arm directly supports the lighthead and adjustable

positioning gooseneck. The gooseneck can be used for fine positioning

without unwanted movement or spring back.

•Lighthead pattern size is adjusted by rotating the end of the lighthead.

•The section of the lighthead used to adjust the pattern is shown in the detail

of Figure 2-3.

The lighthead must always be positioned at working distance between 15" (381

mm) to 22" (559 mm) from the patient. The lighthead pattern size can be

adjusted from a diameter of 2” (50 mm) to 6” (152 mm) while positioned within

the working distance.

This ceiling-mounted component contains the light source of the DeepSite

system, as well as much of the essential system control circuitry and mechani-

Lighthead and

Suspension

Figure 2-3. Lighthead and Adjustable Positioning Gooseneck

Positioning

Gooseneck Rotate this Section of

Lighthead to Adjust

Light Pattern Size

WARNING –PINCHING

HAZARD: Pinch points are

created during extreme ar-

ticulation of the suspen-

sion system. Do not place

hands on or near the sus-

pension knuckle during

lighthead articulations.

CAUTION: Do not bump

lighthead into walls or

other equipment.

WARNING –PERSONAL

INJURY HAZARD: Eye in-

jury may result from expo-

sure to this lamp. Avoid

looking directly at the high-

intensity light, whether at

lamp, directly at the

lighthead, or fiber optic

cable.

WARNING –PERSONAL

INJURY HAZARD: STERIS

does not recommend us-

ing the light closer than

15" (381 mm) from the pa-

tient.

2-5

Component Identification Operator Manual P-129380-133

Ceiling-mounted

Illuminator Housing

Figure 2-4. Ceiling-mounted Illuminator

Lamp Housing

Lock Handle*

Service Access Latch

(to Circuit Breakers)

cal components. The user accesses the housing to change lamps. Typically

this part of the system is only accessed when the lamp reaches the end of its

use cycle.

Circuit breakers for emergency ON/OFF are located behind the service

access panel.

* NOTE: Lamp-life indicator (on wall control)

automatically resets to New Lamp if the

lamp housing lock lever is open for 25

seconds while the circuit breaker is ON.

2-6

P-129380-133 Operator Manual Component Identification

This Page Intentionally Left Blank

3-1

Operating Instructions Operator Manual P-129380-133

OPERATING INSTRUCTIONS

Refer to Figure 3-1.

The wall control is used to turn the lamp in the illuminator housing on or off, and

to vary the intensity level of the light pattern.

[symbol] Press this membrane touch pad to turn the lamp ON.

[symbol] Press this membrane touch pad to turn the lamp OFF.

Press this membrane to DECREASE the pattern intensity level.

Press this membrane to INCREASE the pattern intensity level.

Wall Control

» Illumination Intensity

» Lamp

WARNING –PERSONAL

INJURY HAZARD: Eye in-

jury may result from expo-

sure to this lamp. Avoid

looking directly at the high-

intensity light, whether at

lamp, directly at the light-

head, or fiber optic cable.

CAUTION: This device has

been tested and found in

compliance with IEC

60601-1-2 (1st Edition

1993-04), Medical Electri-

cal Equipment –Part 1:

General Requirements for

Safety; Electromagnetic

Compatibility (EMC). There

is, however, a potential for

electromagnetic or other

interference between this

equipment and other de-

vices. Should you experi-

ence interference, relocate

this device or minimize the

use of the affected equip-

ment while this device is

in operation.

WARNING –EXPLOSION

HAZARD: Do not use this

lighting fixture in the pres-

ence of flammable anes-

thetics.

LAMP

INTENSITY

LAMP LIFE

SYSTEM

POWER

REPLACE LAMP

Fiber Optic Light

THERMAL

SHUTDOWN

DeepSite

Lamp

ON/OFF

Control

Illumination

Intensity

Controls

System Power

Indicator

Thermal

Shutdown

Indicator

Illumination

Intensity

Indicator

Lamp-life

Indicator

Figure 3-1. DeepSite Wall Control

Lamp ON

Indicator

3-2

P-129380-133 Operator Manual Operating Instructions

Check the lamp-life indicator before the beginning of any or all procedures.

• If the AMBER (non-flashing) LED is illuminated, the lamp should be changed

at the earliest opportunity.

• If the AMBER (flashing) LED is illuminated, the lamp must be changed before

using the lighting system in a procedure.

Refer to Lamp Replacement procedure in Section 6 of this manual when it

becomes necessary to change the system lamp.

Lighthead positioning gooseneck (see Figure 3-3) can be adjusted into a

stable curved position. Lighthead may also: (1) rotate 340° around vertical

suspension tube; (2) rotate 360° around centra mount; (3) move up or down by

pivoting at suspension fork 15° up, and 90° down until vertical (i.e., full

movement up and down through 105°).

Check Lamp-Life

Indicator

Lighthead

Positioning

WARNING –PINCHING

HAZARD: Pinch points are

created during extreme ar-

ticulation of the suspen-

sion system. Do not place

hands on or near the sus-

pension knuckle during

lighthead articulations.

CAUTION: Do not bump

lighthead into walls or

other equipment.

Figure 3-2. Lamp-life Indicator

LAMP LIFE

REPLACE LAMP

Amber

LED

(Change Lamp

Soon)

Flashing

Amber

LED

(Change Lamp

NOW)

Figure 3-3. Lighthead Positioning Gooseneck

Lighthead

Positioning

Gooseneck

3-3

Operating Instructions Operator Manual P-129380-133

The light pattern size is adjusted by grasping the lighthead with one hand and

gently rotating in a clockwise (larger) or counterclockwise (smaller) direction.

Refer to Figure 3-4.

NOTE: Pattern diameter can also be adjusted by changing the distance

between the lighthead and the patient. Do not position the lighthead closer than

15" (381 mm) from the patient.

» Light Pattern

Adjustment

WARNING –PERSONAL

INJURY HAZARD: Eye in-

jury may result from expo-

sure to this lamp. Avoid

looking directly at the high-

intensity light, whether at

lamp, directly at the light-

head or fiber optic cable.

STERIS does not recom-

mend using the light closer

than 15" (381 mm) from

the patient.

Figure 3-4. Pattern Size Adjustment at Lighthead

Rotate this Section of

Lighthead to Adjust

Light Pattern Size

Minimum Diameter

(Smaller pattern can also be

achieved by positioning lighthead

closer to patient.)

Maximum Diameter

(Larger pattern can also be

achieved by positioning lighthead

further from patient.)

3-4

P-129380-133 Operator Manual Operating Instructions

Disposable Sterile

Sleeve

Each time the lighting system is used for a surgical procedure, a sterile sleeve

should be used to cover the lighthead and adjustable suspension arm. Refer

to Figure 3-5.

1. Remove protective packaging from the sleeve.

2. Slip the sleeve over the lens holder end of the lighthead.

3. Securely fit the sleeve's end ring to the lighthead's lens cover. Ensure the

end ring is snug (parallel) to the lens cover.

4. Slowly unfold sleeve until the suspension arm is covered to the knuckle.

NOTE: Allow enough slack in the sleeve for lighthead positioning.

5. Once the sleeve is fully unfolded, and a suitable area of the lighthead and

suspension is covered; tear the adhesive tape off the sleeve and remove the

white backing. Wrap the tape tightly around the sleeve, anywhere along the

suspension arm assembly.

NOTE: The tape must be securely wrapped around the sleeve, only. Tape

MUST NOT be applied to the surface of the suspension arm.

IMPORTANT: The sterile sleeve is intended as a single-use item. Sleeve must

be removed from lighting fixture at the end of each procedure and disposed

of following facility waste protocols.

WARNING –BIOHAZARD:

Sterile sleeve is intended

for single use only.

WARNING –BIOHAZARD:

Universal precautions

must be observed when

disposing of the sterile

sleeve.

Sleeve

Adhesive

Tape

Lighthead

Lens Cover

Adjustable

Suspension

Arm

Figure 3-5. Fit Disposable

Sterile Sleeve to Lighthead

Knuckle

4-1

Cleaning the Equipment Operator Manual P-129380-133

CLEANING THE EQUIPMENT

•Pail

•Sponge

•Cloth Wipes

•Rubber Gloves

•Coverage® Spray HB*

•Germicidal Cloths*

•Any other protective equipment recommended by cleaning product manu-

facturer

NOTE: Always follow manufacturer instructions for concentrations and use of

cleaning products.

*Available from STERIS Corporation, please contact your sales representative.

WARNING–PERSONAL

INJURY HAZARD: Read

and follow warnings and

instructions found on de-

tergent labels and Mate-

rial Safety Data Sheets.

CAUTION: Use only a soft,

clean cloth dampened in a

solution of mild detergent

and water to clean the ex-

terior of this light. Always

follow manufacturer in-

structions for concentra-

tions and use of cleaning

products.

CAUTION: Prevent fluid

leakage into the lighting

system; do not use excess

amounts of fluid during

cleaning/disinfecting pro-

cedure.

General Cleaning/

Disinfecting

Procedure

1. Wear rubber gloves.

2. Use sponge and a mild detergent and water solution.

3. Prepare cleaning solution in accordance with directions on the container

labels (follow manufacturer instructions for concentrations when using any

cleaning products).

4. Using a soft cloth and the cleaning solution, thoroughly wipe the areas to be

cleaned (see Figure 4-1). Make sure to wring out excess solution before

wiping.

5. Rinse all surfaces with a soft cloth wipe and clear water.

6. Wipe all surfaces dry with a clean, dry cloth.

Cleaning Equipment

4-2

P-129380-133 Operator Manual Cleaning the Equipment

Areas to be Cleaned

Before Each Use

Figure 4-1. Areas to Be Cleaned

CAUTION: Use only a soft,

clean cloth dampened in a

solution of mild detergent

and water to clean the ex-

terior of this light. Always

follow manufacturer in-

structions for concentra-

tions and use of cleaning

products.

CAUTION: Prevent fluid

leakage into the lighting

system, do not use excess

amounts of fluid during

cleaning/disinfecting pro-

cedure.

Suspension

Knuckle

Vertical

Suspension

Tube Lighthead

Upper

Suspension

Arm

Refer to Figure 4-1.

The following areas of the lighthead and suspension system must be cleaned

and disinfected before each use of the lighthead (see “General Cleaning/

Disinfecting Procedure” for instructions):

•Suspension Arm –Wipe the entire suspension arm, including the suspen-

sion knuckle and adjustable arm section.

•Lighthead –Wipe the entire outer surface of the lighthead.

Inboard Hub of

Centra Mount

Adjustable

Positioning

Gooseneck

Adjustable (Lower)

Suspension Arm

Outboard Hub of

Centra Mount

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Steris Deepsite Fiber Optic Light Operating instructions

Brand: Steris

Model: Deepsite Fiber Optic Light

Type: Operating instructions

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Steris Deepsite Fiber Optic Light Operating instructions

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