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 129382-528

A WORD FROM STERIS® CORPORATION

Indications for Use

This manual contains important information on proper use and care

of this surgical examination lighting system. All operators and

department heads are urged to carefully review and become

familiar with the warnings, cautions, and instructions contained

herein.

Your new examination lighting system features an advanced, state-

of-the-art design, with cool, shadow-reduced light, and ease of

maneuverability. It produces light of a quality necessary for the most

demanding diagnostic examinations.

Complete instructions for uncrating and connecting utilities, as well

as equipment drawings, should have been furnished. If missing,

contact STERIS for replacement copies, giving the serial number

and model numbers of the unit.

A thorough preventive maintenance program is essential to safe

and proper operation of your surgical light. You are encouraged to

contact STERIS concerning our annual maintenance agreements.

Under the terms of this agreement, preventive maintenance, adjust-

ments, and replacement of worn parts are done on a scheduled

basis to assure lighting fixture performs at peak capability and to

help avoid untimely or costly downtime. STERIS maintains a global

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

service, as well as expert repair services. Contact your STERIS

representative for details.

The HarmonyTM LA 300 Examination Lighting Fixture provides

cool, color-corrected, shadow-controlled illumination of the ex-

amination field during examination procedures.

The Harmony LA 300 light is designed for physician’s offices,

clinics, emergency rooms, critical care areas, nursing homes,

and veterinarian offices. The Harmony LA 300 produces a large

light pattern with the same superior color rendition found in

STERIS’s major surgical lights. Additionally, the Harmony LA

300 is easy to position and once in place, remains stationary,

eliminating drift that can interrupt procedures.

129382-528 Operator Manual Table of Contents

Manufactured by:

STERIS Corporation

2720 Gunter Park East

Montgomery, AL 36109 • USA

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 anesthetic

mixture with air or oxygen or nitrous oxide.

Suitable for continuous operation.

STERIS Ltd.

Chancery House

190 Waterside Road

Hamilton Industrial Park

Leicester

LE5 1QZ

United Kingdom

The base language of this document is ENGLISH.

Any translations must be made from the base

language document.

Manufactured exclusively at the STERIS Corporation,

Montgomery, AL facility, which is ISO13485 Certified

iii

Table of Contents Operator Manual 129382-528

TABLE OF CONTENTS

Harmony™ LA 300 Examination Lighting Fixture

Section Paragraph Page

1 Listing of Safety Precautions ........................................................... 1-1

1.1 Definition of Symbols .................................................................................................. 1-2

2 Using the Equipment .........................................................................2-1

2.1 Components of the Equipment ................................................................................... 2-1

2.2 Before Operating The Mobile Stand ............................................................................ 2-1

2.3 Intensity Control Buttons ............................................................................................. 2-2

2.4 Transporting the Mobile Stand .................................................................................... 2-3

2.5 Lighthandle and Lighthandle Cover ............................................................................ 2-4

2.6 Harmony LA 300 Lighthead Optical Performance ...................................................... 2-5

2.7 Lamp Replacement: Harmony LA 300 Lightheads ..................................................... 2-6

3 Cleaning the Equipment ....................................................................3-1

3.1 Cleaning Equipment ................................................................................................... 3-1

3.2 General Cleaning/Disinfecting Procedure ................................................................... 3-2

4 Replacement Parts ............................................................................4-1

129382-528 Operator Manual Table of Contents

This Page Intentionally Blank.

1−1

Listing of Warnings and Cautions Operators Manual 129382-528

LISTING OF SAFETY PRECAUTIONS

The following is a summary of safety precautions which must be observed when operating or servicing this lighting

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

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

read all precautions before proceeding to use or service this equipment.

WARNING – ELECTRIC SHOCK HAZARD:

In case of contact with damaged electrical parts, there is a danger of an electrical shock. In case of any

damage to the power supply cable or plug, do not connect the equipment to the power supply and

immediately inform the service department.

Do not remove power supply cover. Refer servicing to qualified service personnel.

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

to qualified service personnel.

WARNING – PERSONAL INJURY HAZARD:

Do not attempt to replace the lamp until it 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.

WARNING – POSSIBLE PATIENT INJURY HAZARD:

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

procedure.

CAUTION – POSSIBLE EQUIPMENT DAMAGE HAZARD:

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

the lens surface: Coverage® Spray HB Ready-to-Use Disinfectant Cleaner, Coverage® HB Concentrate,

Coverage Plus® Non-Sterile Disinfectant Cleaner, Coverage® Spray Ready-to-Use Disinfectant Cleaner,

Vesphene® IIse Non-Sterile Disinfectant Cleaner, or Bactoshield®

CHG 4% Surgical Scrub. 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 antistatic 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.

Prevent leakage of fluids into interior of lighthead, or suspension system.

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 external surfaces.

1−2

129382-528 Operators Manual Listing of Warnings and Cautions

CAUTION – POSSIBLE EQUIPMENT DAMAGE HAZARD: (Continued)

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.

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 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 bump lightheads into walls or other equipment.

Secure lighthead in lower position with safety strap before transporting.

1.1 Definition of

Symbols

Symbol Definition

Protective Earth (Ground)

Attention, consult manual for further

instructions

Hot

+Increase Intensity (Surgeon's Control

Buttons)

–Decrease Intensity (Surgeon's Control

Buttons)

Shock Hazard

2-1

Using the Equipment Operator Manual 129382-528

USING THE EQUIPMENT

See Figure 2-1.

Ceiling Wall-mounted Mobile

Equipment: Equipment: Stand Equipment:

• Ceiling Plate • Wall Mount • Base

• Vertical Tube • Extension Arm • Casters

• Extension Arm • Spring Arm • Vertical Support

• Spring arm • Harmony LA 300 • Spring Arm

• Harmony LA 300 Lighthead • Harmony LA 300

Lighthead Lighthead

NOTE: Mobile stand may tip over if it is rolled over its own connect-

ing cable or any other object(s) on the floor.

1. Move the mobile stand to the location of use and secure the two

locking casters.

2. Check the power plug and the connection cable for damage.

3. The power plug should be inserted into a contact-protected

power socket that has been installed and grounded in accor-

dance with regulations.

2.2 Before Operating The

Mobile Stand

2.1 Components of the

Equipment

WARNING – ELECTRICAL SHOCK

HAZARD: In case of contact with

damaged electrical parts, there is a

danger of an electrical shock. In

case of any damage to the power

supply cable or plug, do not con-

nect the equipment to the power

supply and immediately inform the

service department.

2-2

129382-528 Operator Manual Using the Equipment

Figure 2-1. Standard Lighthead Articulation Ranges

Ceiling Plate

Vertical Tube

Extension arm

Spring Arm

Wall Mount

Extension Arm

Spring Arm

Vertical Support

Tube

Base

Casters

Power Plug

85°

360°

30°

360°

180°

360°

310°

Harmony LA 300 Lighthead

Harmony LA 300

Lighthead

Harmony LA 300

Lighthead

2-3

Using the Equipment Operator Manual 129382-528

Figure 2-2. Lighthead Intensity Control Buttons

Intensity Control

Buttons

Refer to Figure 2-2.

1. Grasp the handle of the lighthead. Four membrane buttons

(bumps) are located on the control bezel adjacent to the light-

handle.

2. Press either of the intensity membrane buttons with “+” symbols

(right button) to increase the lighthead intensity. Press either of

the membrane buttons molded with “-” symbols (left button) to

decrease lighthead intensity.

NOTE: For longer lamp life, use lowest intensity level suitable for

procedure.

3. To turn lighthead ON, press and hold any of the “+” membrane

buttons until light turns on. To turn lighthead OFF, press and hold

any of the “-” membrane buttons until the light goes out.

2.4 Transporting the

Mobile Stand

CAUTION: Secure lighthead in

lower position with safety strap

before transporting.

Lower the lighthead and secure in place with safety strap before

transporting (rolling) the mobile stand.

Figure 2-3. Secure Safety Strap for Transport

Safety

Strap

2.3 Intensity Control

Buttons

CAUTION: Appropriate compo-

nents of this lighting system have

been tested and found in compli-

ance with IEC 60601-1-2 (1st Edi-

tion 1993-04), Medical Electrical

Equipment – Part 1: General Re-

quirements for Safety; Electromag-

netic Compatibility (EMC). There is

a potential for electromagnetic or

other interference between this

equipment and other devices.

Should you experience interfer-

ence, relocate this device or mini-

mize the use of the affected equip-

ment while this device is in opera-

tion.

2-4

129382-528 Operator Manual Using the Equipment

2.5 Lighthandle and

Lighthandle Cover

Lighthandles are used to position the Harmony LA 300 lighthead

and allow access to intensity control. To avoid accidental contact

with the non-sterile control buttons, the lighthandle should always

be used with a disposable, sterile lighthandle cover (available

separately from STERIS).

• Prior to starting a procedure, ensure that the lighthandle is in

place. Install the lighthandle by threading onto the adapter and

firmly tightening (see Figure 2-4a).

• Remove the sterile lighthandle cover from its packaging, align

the lighthead and spring arm, and install onto the lighthandle (see

Figure 2-4b).

• To ensure the lighthandle cover remains in place during the

procedure, the groove in the cover must be fully engaged with the

groove in the lighthandle. See Figure 2-4c.

• The lighthandle can be removed for cleaning or sterilization by

unscrewing it from the handle adapter. The lighthandle can be

sterilized using standard hospital cycles. Do not use the light-

head during a sterile procedure unless a sterile disposable cover

is installed on the lighthandle.

WARNING–POSSIBLE PATIENT

INJURY HAZARD: Failure to engage

the lighthandle cover completely

may result in cover falling from light-

head during the procedure.

Figure 2-4a. Install Lighthandle

Figure 2-4c. Install Sterile Disposable Cover

Figure 2-4b. Align Lighthead and

Srping Arm

Lighthandle

Push Cover Completely

Onto Lighthandle

Install Standard Lighthandle

Align lighthead and spring arm as shown

when installing sterile covers.

Disposable

Lighthandle Cover

Install Disposable Lighthandle Cover

Immediately Before Procedure

Lighthead

Spring Arm

2-5

Using the Equipment Operator Manual 129382-528

2.6 Harmony LA 300

Lighthead Optical

Performance

Important: Values are typical for the 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 (range for intensity settings 1-7).................. 2,200 - 5,500 fc (24,000 - 59,000 lux)

Pattern size

D10 ............................................................................................................................................................. 8-1/4" (210mm)

D50 ............................................................................................................................................................. 46-1/4" (107mm)

Depth of Illumination .................................................................. > 60" (>1524mm)

Peak Total Irradiance ................................................................. < 250 W/m2

Color Temperature ..................................................................... 4400 K

Color Rendering Index (CRI)...................................................... 94

Shadow Control

Single Mask: .......................................................................... 0%

Double mask: ......................................................................... 66%

Cavity: ................................................................................... 100%

Single mask with cavity: ......................................................... 0%

Double mask with cavity: ....................................................... 68%

Average Lamp Life (at mid-range intensity) ................................ 1,000 hours

2-6

129382-528 Operator Manual Using the Equipment

Harmony LA 300 lightheads are equipped with a single lamp.

Important: The lampholder module is accessed from the top of the

lighthead and removed. Once removed, the spent lamp is replaced

with a fresh lamp.

To replace a failed lamp, refer to Figure 2-5 and follow the steps

outlined in the procedure below:

1. Allow lighthead and lampholder to cool until both are comfort-

able to touch.

2. Rotate the lighthead until it is horizontal and in a comfortable

position to reach the top access hood on the top.

3. Slide the latch on the access hood, and lift to open.

4. Press down on the push-release/push-lock fasteners on the

lampholder. Remove the lampholder module from the lighthead.

5. Remove the failed lamp by grasping the lamp base in one hand

and the lampholder in the other, then gently pull the lamp from the

socket.

6. Grasp the new lamp by its base or protective wrapper (do not

remove protective wrapper, do not touch glass) and press into

the lampholder until lamp is fully seated.

•Remove the protective wrapper.

• Inspect lamp to verify that it is fully seated and has an intact

filament.

7. Return the lampholder to the lighthead.

• Press the lampholder firmly into the lighthead. Press down on

the push-release/push-lock fasteners to lock the lampholder

in place.

NOTE: If the fasteners appear to be loose, they are not

locked.

• Firmly push straight down on the access hood until it locks.

Slide the latch fully into the closed position, if necessary.

8. Test the lighthead by turning it ON.

2.7 Lamp Replacement:

Harmony LA 300

Lightheads

WARNING – ELECTRIC SHOCK

HAZARD: Do not remove covers or

perform service other than as de-

scribed in this equipment manual.

Refer servicing to qualified service

personnel.

WARNING – PERSONAL INJURY

HAZARD: Do not attempt to replace

the lamp until it has cooled suffi-

ciently.

WARNING – PERSONAL INJURY

HAZARD: Avoid looking directly at

high-intensity light, whether at the

lamp or directly at the lighthead.

Eye injury may result.

CAUTION: Do not touch the glass

portion of the lamp with bare fin-

gers. Skin oils can cause deteriora-

tion of material leading to possible

failure of the lamp.

2-7

Using the Equipment Operator Manual 129382-528

Figure 2-5. Lamp Replacement Procedure–Harmony LA 300 Lighthead

• Open sliding catch on hinged

access hood.

• Open access hood.

Press and release fasteners to

release lampholder

Fastener in released position

Harmony LA 300 lampholder requires a

single replacement lamp

2-8

129382-528 Operator Manual Using the Equipment

This Page Intentionally Blank.

3-1

Cleaning the Equipment Operator Manual 129382-528

• Pail

• Sponge

• Cloth Wipes

• Rubber Gloves

• Mild Household Detergent (e.g., dish washing liquid)

• Disinfectant cleaners such as:

» Coverage® Spray HB Ready-to-Use Disinfectant Cleaner

» Coverage® HB Concentrate

» Coverage Plus® Ready-to-Use Disinfectant Cleaner

» Coverage® Spray Ready-to-Use Disinfectant Cleaner

» Vesphene® IIse Non-Sterile Disinfectant Cleaner

» Bactoshield® 4% CHG Surgical Scrub

All listed disinfectant cleaning products are available from STERIS.

CLEANING THE EQUIPMENT

3.1 Cleaning Equipment

WARNING – PERSONAL INJURY

HAZARD: Do not attempt to clean

lighthead unless power is turned off

and the lighthead has cooled

sufficiently.

CAUTION: Use of any disinfectant

solution OTHER than those listed

below may cause discoloration or

deformation on the lens surface:

Coverage® Spray HB Ready-to-Use

Disinfectant Cleaner, Coverage® HB

Concentrate, Coverage Plus® Non-

Sterile Disinfectant Cleaner, Cover-

age® Spray Ready-to-Use Disinfec-

tant Cleaner, Vesphene® IIse Non-

Sterile Disinfectant Cleaner, or

Bactoshield® CHG 4% Surgical

Scrub. Cleaning solutions other than

those listed have NOT been tested

for compatibility or effectiveness.

Always follow manufacturer instruc-

tions for concentrations and use of

cleaning products.

CAUTION: 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 phe-

nolic-, iodophor-, or glutaraldehyde-

based disinfectant is used on the

surfaces of this light. Also, use of

alcohol or aerosol spray cleaner/dis-

infectants containing a substantial

amount of alcohol in the formula can

damage the polycarbonate lens.

CAUTION: Prevent leakage of fluids

into interior of lighthead or suspen-

sion system.

3-2

129382-528 Operator Manual Cleaning the Equipment

3.2 General Cleaning/

Disinfecting Procedure

1. Wear rubber gloves.

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

following cleaning/disinfecting agents are compatible with the

outer surfaces of the suspension arm, yoke, lighthead and lens

when used in accordance with label instructions: Coverage®

Spray HB Ready-to-Use Disinfectant Cleaner, Coverage® HB

Concentrate, Coverage Plus®

Non-Sterile Disinfectant Cleaner,

Coverage® Spray Ready-to-Use Disinfectant Cleaner,

Vesphene® IIse Non-Sterile Disinfectant Cleaner, or Bactoshield®

CHG 4% Surgical Scrub.

3. Prepare cleaning or disinfecting solution in accordance with

directions on the container label(s).

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

areas to be cleaned. 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.

Important: If disposable lighthandle covers are used, ensure a

new one is used for each procedure.

WARNING – PERSONAL INJURY

HAZARD: Do not attempt to clean

lighthead unless power is turned off

and the lighthead has cooled

sufficiently.

CAUTION: Use of any disinfectant

solution OTHER than those listed

below may cause discoloration or

deformation on the lens surface:

Coverage® Spray HB Ready-to-Use

Disinfectant Cleaner, Coverage® HB

Concentrate, Coverage Plus® Non-

Sterile Disinfectant Cleaner, Cover-

age® Spray Ready-to-Use Disinfec-

tant Cleaner, Vesphene® IIse Non-

Sterile Disinfectant Cleaner, or

Bactoshield® CHG 4% Surgical

Scrub. Cleaning solutions other than

those listed have NOT been tested

for compatibility or effectiveness.

Always follow manufacturer instruc-

tions for concentrations and use of

cleaning products.

CAUTION: 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 phe-

nolic-, iodophor-, or glutaraldehyde-

based disinfectant is used on the

surfaces of this light. Also, use of

alcohol or aerosol spray cleaner/dis-

infectants containing a substantial

amount of alcohol in the formula can

damage the polycarbonate lens.

CAUTION: Prevent leakage of fluids

into interior of lighthead or suspen-

sion system.

4-1

Replacement Parts Operator Manual 129382-528

REPLACEMENT PARTS 4

Parts listed in this section are those that would be necessary to do

minor maintenance on the lighting fixture.

When ordering, please include the part number, description, and

quantity for each replacement part requested.

To order directly, call STERIS.

Plastic Lighthandle P136820-001 (LB20)

HarmonyTM LA 300 Replacement Lamp P093926-113 (LB21)

(22 VDC, 100 W)

Lighthandle Cover (Single), 10 per case P093926-328 (LB41)

4-2

129382-528 Operator Manual Replacement Parts

This Page Intentionally Blank

4-3

Replacement Parts Operator Manual 129382-528

This Page Intentionally Blank

4-4

129382-528 Operator Manual Replacement Parts

This Page Intentionally Blank

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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