Steris Harmony La Surgical Lighting And Visualization System Operating instructions

Brand: Steris

Model: Harmony La Surgical Lighting And Visualization System

Type: Operating instructions

Table of Contents Operator Manual 129382-602

A WORD FROM STERIS CORPORATION

Follow each step of the Installation instructions in the order presented. Open

the carton carefully to avoid damage to the equipment inside. If you find any

indication of damage to the equipment (no matter how slight), show it to your

supervisor.

To properly install this unit, you need the Equipment Drawings (previously

furnished), showing all utility service and space requirements. If these draw-

ings cannot be located, replacement copies may be obtained by writing,

faxing, or telephoning STERIS, giving the serial and model numbers of your

equipment.

Once installed, equipment operation should be tested by a qualified service

technician prior to first usage of the equipment.

If STERIS supervision is desired for installing and starting up this equipment,

contact STERIS.

The STERIS® LA Mobile Stand with STERIS LA 500 lighthead is designed to

provide a flexible, mobile lighting system for various surgical and diagnostic

procedures in healthcare environments.

IMPORTANT: Be sure to check the Occupational Health and Safety Act, as well

as local electric codes, for any special requirements that may pertain to

installation of this unit.

A thorough preventive maintenance program is essential to help ensure safe

and proper equipment operation and to verify equipment performance accord-

ing to factory specifications. Contact STERIS for information on extended

service maintenance agreements, including scheduled equipment mainte-

nance.

A global network of skilled service specialists can provide periodic inspections

and adjustments to help ensure low-cost peak performance. STERIS can

provide detailed information on annual maintenance agreements.

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

Contact STERIS for details.

A listing of the safety precautions to be observed when uncrating, installing,

testing, and operating this equipment can be found in

SECTION 1

of these

instructions. Do not begin installing this equipment until you have become

familiar with this information.

The following is an important message from STERIS about the advantages and

limitations associated with the use of high intensity surgical lighting systems.

Because of the variety of surgical procedures performed and the wide range

of individual preferences of surgical staffs, it is desirable that this surgical

lighting system be capable of selective control across a wide range of

illumination intensities. The Illuminating Engineering Society (IES) stresses

that in addition to providing control of intensity, surgical lighting systems

Indications for Use

Service Information

Advisory

129382-602 Operator Manual Table of Contents

should provide shadow control, correct color rendition, and a suitable depth

of field to provide sharp, consistent lighting into deep body cavities. As

illumination levels increase, however, radiant heat also increases. Therefore,

the IES cautions that for most operations, radiant heat should be kept to

a minimum. The user of surgical lights should utilize the lowest possible

illumination level suitable for the procedure, especially in certain neurological

or intestinal procedures on delicate, thin, dry, or abnormal tissue. Further-

more, for the protection of surgically exposed tissues and for the comfort and

efficiency of the surgeon and assistants, radiant energy can be effectively

controlled by limiting the time of exposure at higher illumination levels. Extra

care must be taken when the light fields from multiple lightheads are

overlapped on the surgical site, since this condition creates a risk of too

much heat.

An international standard for the safety of surgical lights established by the

IEC sets minimum and maximum levels of illumination and maximum levels of

radiant heat that can be emitted from a single surgical luminaire. The STERIS

LA Surgical Lighting System has been designed to comply with this interna-

tional standard and to provide a wide range of illumination levels while

minimizing the potentially damaging infrared heat in the surgical field. The

illumination level of the STERIS LA Surgical Lights can be adjusted through

several intensity settings via conveniently located controls on either the wall-

mounted control center or the lighthead handle. The illumination level also

decreases as the pattern size increases. Maximum illuminance can exceed

12,000 fc for the smallest pattern size with the STERIS LA 500 lighthead and

can be adjusted by intensity control or pattern size control throughout the entire

range specified by the IEC.

Manufactured by:

STERIS Corporation

2720 Gunter Park East

Montgomery, AL 36109 • USA

Tel: 334 277 6660

Fax: 334 271 5450

www.steris.com

The base language of this document is

ENGLISH. Any translations must be

made from the base language document.

STERIS Corporation,

Montgomery, Alabama is an

ISO 13485 certified facility.

iii

Table of Contents Operator Manual 129382-602

TABLE OF CONTENTS

Section Title Page

1 LISTING OF SAFETY PRECAUTIONS............................................. 1-1

2 INSTALLATION INSTRUCTIONS .................................................... 2-1

2.1 Spring Arm Assembly .................................................................................................. 2-1

2.2 Spring Arm Installation................................................................................................ 2-2

2.3 Wire Connections ........................................................................................................ 2-3

2.4 Lighthead Installation .................................................................................................. 2-4

2.5 Adjustments................................................................................................................ 2-6

3 INSTALLATION VERIFICATION ...................................................... 3-1

3.1 Pre-operation Checklist ............................................................................................... 3-1

3.2 STERIS LA 500 Lighthead Optical Performance.......................................................... 3-4

4 OPERATING INSTRUCTIONS.......................................................... 4-1

4.1 Install and Route Power Cord...................................................................................... 4-1

4.2 Transporting the Mobile Stand .................................................................................... 4-2

4.3 Intensity Controls: STERIS LA 500 Lighthead ............................................................. 4-3

4.4 STERIS LA 500 Lighthead Lamp Failure Indications .................................................... 4-3

4.5 STERIS LA 500 Lighthead Positioning ........................................................................ 4-4

4.6 STERIS LA 500 Lighthead Pattern Adjustment .......................................................... 4-5

4.7 Lighthandle and Lighthandle Cover............................................................................. 4-6

4.7.1 Installing and Using Lighthandle and Lighthandle Cover ..................................... 4-6

4.8 Metal Sterilizable Handle ............................................................................................ 4-7

4.9 Mobile Stand Positioning ............................................................................................ 4-8

5 CLEANING THE EQUIPMENT.......................................................... 5-1

5.1 Cleaning Equipment .................................................................................................... 5-1

5.2 General Cleaning/Disinfecting Procedure .................................................................... 5-2

5.3 Areas To Be Cleaned Before Each Use ....................................................................... 5-4

6 OPERATOR TROUBLESHOOTING................................................... 6-1

7 MAINTENANCE................................................................................ 7-1

7.1 Preventive Maintenance Record.................................................................................. 7-1

7.2 Inspect Lampholder Module ....................................................................................... 7-2

7.3 Inspect Mobile Stand .................................................................................................. 7-2

7.4 Lamp Replacement: STERIS LA 500 Lightheads ........................................................ 7-3

8 REPLACEMENT PARTS .................................................................. 8-1

9 WASTE DISPOSAL GUIDELINES .................................................... 9-1

129382-602 Operator Manual Table of Contents

STERIS LA Mobile Stand with STERIS LA 500 Lighthead

Spring Arm Knuckle

Upright Tube

Adapter Head

Spring Arm

Lighthead Yoke

Base

1-1

Installation/Operator Manual Listing of Safety Precautions 129382-602

The following is a listing of the safety precautions which must be observed when uncrating, installing, and operating

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

instructions.

WARNING – LACERATION/EYE INJURY HAZARD:

When removing bands, wear eye protection and always use a tool specifically designed to cut the

bands. The bands used to secure this carton can cause personal injury when cut and tension is

released.

WARNING – LACERATION HAZARD:

When removing bands, wear gloves to protect your hands.

WARNING – EXPLOSION HAZARD:

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

WARNING – ELECTRIC SHOCK AND BURN HAZARD:

Disconnect all utilities to mobile stand before servicing. Do not service this equipment unless all

utilities have been properly disconnected. Always follow OSHA Lockout-Tagout and electrical safety-

related work practice standards. (See CFR 1910.147 and .331 through .335.)

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

servicing to qualified service personnel. (Maintenance Manual P764330-226.)

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.

WARNING–POSSIBLE PATIENT INJURY HAZARD:

Failure to engage the lighthandle cover completely may result in cover falling from lighthead during the

procedure.

LISTING OF SAFETY PRECAUTIONS

1-2

129382-602 Listing of Safety Precautions Installation/Operator Manual

WARNING – BIOHAZARD:

Sterile disposables are intended for single use only.

Universal precautions must be observed when disposing of any single use disposable item.

WARNING – DISPOSAL HAZARD:

This product contains materials which may require disposal through appropriately licensed and

permitted hazardous waste management firms.

WARNING – PERSONAL INJURY HAZARD:

Do not attempt to replace the lamp unless lighthead is turned off and has cooled sufficiently.

Do not attempt to clean lighthead unless power is turned off and the lighthead has cooled

sufficiently.

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

Avoid looking directly at high-intensity light, whether at the lamp or directly at the lighthead. Eye

injury may result.

Do not remove lighthead with light arm in lowered position. Refer to maintenance manual

P764330-226 for correct removal procedures.

WARNING–TRIPPING HAZARD:

Route the power cord to the receptacle in a position so that it will not be tripped over by personnel

in the area.

CAUTION: POSSIBLE EQUIPMENT DAMAGE

Use of any disinfectant solution OTHER than those listed below may cause discoloration or

deformation on the polycarbonate lens surface: T.B.Q.® Hard Surface Disinfectant Cleaner,

Coverage Plus® Concentrated Disinfectant Cleaner, Coverage® Spray Ready-to-Use Disinfectant

Cleaner, or Germicidal Cloth Impregnated Non-Woven Disposable Cloth. Cleaning solutions other

than those listed have NOT been tested for compatibility or effectiveness. Always follow

manufacturer instructions for concentrations and use of cleaning products.

Use only recommended cleaning/disinfecting and/or anti-static agents on this light. Some degree of

staining, pitting, and/or discoloration could occur if a phenolic-, iodophor-, or glutaraldehyde-

based disinfectant is used on the surfaces of this light. Also, use of alcohol or aerosol spray

cleaner/disinfectants containing a substantial amount of alcohol in the formula can damage the

polycarbonate lens.

1-3

Installation/Operator Manual Listing of Safety Precautions 129382-602

Prevent leakage of fluids into interior of lighthead.

Secure lighthead in lower position with safety chain before transporting.

Do not scratch optical coating on accessible portions of optic assembly when cleaning; always

wear rubber gloves and use only a clean, white, lint-free cloth when wiping surfaces.

Appropriate components of this lighting system have 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.

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

material leading to possible failure of the lamp.

Do not bump lightheads into walls or other equipment.

During all mounting steps, verify wires are not pinched between mechanical components.

1-4

129382-602 Listing of Safety Precautions Installation/Operator Manual

Healthcare

Capital Equipment

2-1

Installation/Operator Manual Installation Instructions 129382-602

INSTALLATION INSTRUCTIONS

1. Slide adapter collar down over spring arm knuckle tube.

2. Align slot in adapter collar to proper location. See Figure 2-1.

3. Secure adapter collar with four 8-32 x .375 flat head screws.

Loctite screws in place with loctite supplied.

2.1 Spring Arm

Assembly

Figure 2-1. Install Adapter Collar to Spring Arm

Knuckle covers shown in this view are

shipped loose from spring arm assembly.

Adapter

Collar

Screw 8-32 x .375

(Four Required)

Knuckle

Tube

Spring Arm

Assembly Slot

2-2

129382-602 Installation Instructions Installation/Operator Manual

NOTE: Parts of this step may require two people.

1. Raise spring arm and slide adapter collar up into adapter head

bearings.

2. Place thrust washers (2) and thrust bearing over adapter collar

inside adapter head. A thrust washer is to be located on top and

bottom of thrust bearing. See Figure 2-2.

3. Secure spring arm and bearings with retaining ring.

4. Install stop screw in side of adapter head. End of stop screw is

to protrude through slot in adapter collar.

• Do not over tighten.

• Verify spring arm horizontal motion stops in both directions

(approx. ±15° from center).

5. Install brake screw in side of adapter head opposite from stop

screw. Adjust brake to allow spring arm to move freely from side

to side but without drift.

2.2 Spring Arm

Installation

Figure 2-2. Install Spring Arm to Mobile Stand

Knuckle covers shown in this view are

shipped loose from spring arm assembly.

Adapter

Head

Brake

Screw

Thrust Washer

(2" / 50 mm)

Retaining Ring

(2" / 50 mm)

Thrust Bearing

(2" / 50 mm)

Stop

Screw

Upright

Tube

Spring Arm

Assembly

2-3

Installation/Operator Manual Installation Instructions 129382-602

1. Route mobile stand wire harness down through center of adapter

head into spring arm knuckle. See Figure 2-3.

2. Snap harness connector into harness connector plate.

3. Connect spring arm harness connector to mobile stand harness

connector.

4. Install spring arm knuckle cover.

5. Install plug button in top of adapter head. See Figure 2-4.

2.3 Wire Connections

Figure 2-4. Install Plug Button

Adapter

Head

Plug Button

(3" / 76 mm)

Figure 2-3. Wiring Connections

Mobile

Stand Wire

Harness Upright

Tube

Adapter

Head

Harness

Connector

Harness

Connector

Plate

Spring Arm

Knuckle

Spring Arm

Wire Harness

Mobile Stand

Wire Harness

2-4

129382-602 Installation Instructions Installation/Operator Manual

NOTE: Parts of this step may require two people.

1. Mate connectors from lighthead to spring arm yoke.

2. Align pin on spring arm yoke mounting flange to unthreaded hole

on lighthead mounting flange. See Figure 2-5.

3. Attach lighthead to the spring arm yoke with four .250-20 screws

supplied with lighthead.

2.4 Lighthead

Installation

Figure 2-5. Install Lighthead to Spring Arm

Align Key at Spring

Arm Connection

Point

Feed Connectors

and Wires

Completely through

Yoke Interface Plate

before Mechanically

Mating Yoke and

Lighthead

Alignment Keys

Yoke Interface Plate Lighthead Interface

Plate

Lighthead

Fasteners

WARNING - PERSONAL INJURY

HAZARD: Do not remove lighthead

with light arm in lowered position.

Refer to

Maintenance Manual

(P764330-226) for correct removal

procedures.

CAUTION: During all mounting steps,

verify wires are not pinched between

mechanical components of suspen-

sion, spring arms, or lightheads.

2-5

Installation/Operator Manual Installation Instructions 129382-602

4. Mechanically and electrically connect lighthead.

5. Pull wires out of the yoke (see Figure 2-6a) then pull slack out of

the yoke until two connectors are pulled into yoke at lighthead.

6. Wires leading into lighthead should be pulled snugly (but not too

tight) as shown in Figure 2-6b, with connectors drawn into yoke.

7. Fold wire back on itself from furthest point from yoke, then push

this end into yoke tube as shown in Figure 2-6c.

8. Push wires down into yoke tube allowing only about 1" (51 mm)

of wire to be pushed back out of lighthead to yoke transition.

(See Figures 2-6d and 2-6e.) This allows some slack for wiring

loop at the lighthead.

Verify wires are not bunched up in opening to lighthead. Also

make sure bushing, which rotates with lighthead, does not

abrade wires.

Figure 2-6a

Figure 2-6. Dress Wiring for Lighthead Electrical Connections

Figure 2-6b

Figure 2-6c

Figure 2-6d Figure 2-6e

CAUTION: During all mounting steps,

verify wires are not pinched between

mechanical components of suspen-

sion, spring arms, or lightheads.

Spring arm to

yoke transition

2-6

129382-602 Installation Instructions Installation/Operator Manual

Make adjustments to spring arm, as necessary, to accommodate

weight of lighthead by removing access cover located on spring

arm.

Make adjustments to brakes on yoke, as necessary.

Install covers on yoke/tube and yoke/lighthead connection. See

Figure 2-7.

2.5 Adjustments

Figure 2-7. Adjust Brake Friction and Install Pivot Cover

Brake Screws

Brake Screw

Access Cover for

Tension Adjustment Remove Access Cover Screw and Slide

Cover Back to Adjust Yoke Brake

3-1

Installation/Operator Manual Installation Verification 129382-602

WARNING – ELECTRIC

SHOCK HAZARD: Do not

remove covers or perform

service other than as de-

scribed in this operator

manual. Refer servicing

to qualified service per-

sonnel (Maintenance

Manual P764330-226)

An equipment drawing showing all of the space and utility requirements was

sent to the purchaser after the order for this surgical light was received. The

clearance space shown on the drawing is necessary for proper installation,

operation, and maintenance of this fixture.

Uncrating Instructions were furnished with the Mobile Stand.

If these documents are missing or misplaced,

contact STERIS, giving the serial

and model numbers of the equipment. A replacement copy will be sent to you

promptly.

Before operating the STERIS® LA 500 Mobile Stand, complete the following

pre-operation checklist. It is essential to the safe operation and continuing

maintenance of this equipment to verify the installation is complete and

correct. (Refer to Figures 3-1 and 3-3 to locate components.)

INSTALLATION VERIFICATION 3

3.1 Pre-Operation

Checklist

3-2

129382-602 Installation Verification Installation/Operator Manual

Check Mobile Stand Suspension Movement

Check all suspension joints for compromised integrity, such as loose fasten-

ers or components. (See Figure 3-1.)

Verify suspension system moves through all articulations smoothly without

binding. Lightheads and arms should move smoothly and easily. When

positioned, lighthead support arms should not drift. If binding or drifting is

present in suspension movements, call STERIS to make adjustments.

Figure 3-1. Check Mobile Stand Suspension

Check these and all similar areas

for ease of movement, as well as

suspension integrity

55°

30°

310°

360°

3-3

Installation/Operator Manual Installation Verification 129382-602

Check Mobile Stand Casters

Verify all four mobile stand casters roll and swivel freely. Verify the locking

mechanisms lock and unlock correctly (see Figure 3-2).

Figure 3-2. Check Mobile Stand Caster Locks

Check Lighthead Operation

Verify electrical power to mobile stand is on; and mobile stand is connected

to correct supply outlet.

Check Lamp Failure LED:

If LED on lighthead covers is blinking, one or

both of the fixture’s lamps may have to be replaced. (Refer to

LAMP

REPLACEMENT, SECTION 7

Check Intensity Controls at Surgeon's Control Buttons: Verify inten-

sity level can be increased and decreased at each lighthead using

surgeon's control buttons (see Figure 3-3).

Figure 3-3. Use Surgeon's Control Buttons to Check

Lighthead Intensity Operation

Surgeon's

Control

Buttons

Standard

Lighthandle

3-4

129382-602 Installation Verification Installation/Operator Manual

Important: Values are typical for the small pattern size at highest intensity

setting (unless otherwise noted) at 39 3/8" (1m) from the lighthead. Defini-

tions and measurements are in accordance with IEC 60601-2-41.

Central

Illuminance 5,000 – 12,000 fc

(range for intensity settings 1-7)

Pattern Size

D10 5

3/4 –11 1/4" (145 – 290 mm)

D50 3–6

1/2" (75– 165 mm)

Depth of

Illumination 43" (1092 mm)

Peak total

Irradiance < 800 W/m2

Color

Temperature 4400 K

Color Rendering

Index (CRI) > 90

Shadow Control

Single Mask: 31%

Double Mask: 43%

Cavity: 100%

Single mask w/ cavity: 32%

Double mask w/ cavity: 44%

Average

Lamp Life 1,200 hrs at mid-range intensity

3.2 STERIS LA 500

Lighthead

Optical

Performance

4-1

Installation/Operator Manual Operating Instructions 129382-602

Refer to Figure 4-1.

1. Place STERIS® LA 500 Mobile Stand at desired location.

2. Connect female end of 20' (6 m) long power cord to connector located on

lower rear of the mobile stand base.

3. Route power cord to wall receptacle so that it will not be tripped over, then

plug it into an appropriate receptacle.

4.1 Install and

Route Power Cord

WARNING – TRIPPING

HAZARD: Route the

power cord to the

receptacle in a position

so that it will not be

tripped over by personnel

in the area.

Figure 4-1. Install and Route Power Cord

OPERATING INSTRUCTIONS 44

Power Switch

ON(-)/OFF(0)

IEC Connector

Power

Cord

To Wall

Receptacle

4-2

129382-602 Operating Instructions Installation/Operator Manual

4.2 Transporting

the Mobile Stand

Lower lighthead and secure in place with safety chain before transporting

(rolling) mobile stand.

CAUTION: Secure light-

head in lower position

with safety chain before

transporting.

Figure 4-2. Use Safety Chain During Transport

Safety

Chain

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Steris Harmony La Surgical Lighting And Visualization System Operating instructions

Steris Harmony La Surgical Lighting And Visualization System Operating instructions

Steris Harmony La Surgical Lighting And Visualization System Operating instructions

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