Steris Harmony La Surgical Lighting And Visualization System Operating instructions

Brand: Steris

Model: Harmony La Surgical Lighting And Visualization System

Type: Operating instructions

OPERATOR MANUAL

Harmony LL Lighting System

(03/10/03) P-129378-368

Table of Contents Operator Manual 129378-368

A WORD FROM STERIS CORPORATION

This manual contains important information on proper use and care of the

Harmony LL Lighting System. 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 the Harmony LL Lighting System and should be retained in a

conveniently accessible area for quick reference.

Complete instructions for installation, 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.

The Harmony LL surgical lights are intended for use in operating and treatment

rooms to locally illuminate areas of a patient’s body undergoing surgery or

examination.

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.

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.

Service Information

Advisory

129378-368 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 docu-

ment.

EC Authorized Representative

STERIS Ltd.

STERIS House

Jays Close

Viables

Basingstoke

Hampshire

RG22 4AX

UNITED KINGDOM

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 anesthetic

mixture with air or oxygen or nitrous oxide.

Suitable for continuous operation.

iii

Table of Contents Operator Manual 129378-368

TABLE OF CONTENTS

Section Title Page

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

2 PREPARATION AND OPERATION ................................................... 2-1

2.1 Preparation ................................................................................................................... 2-1

2.2 Operation ..................................................................................................................... 2-1

2.2.1 Operation .............................................................................................................. 2-2

2.2.2 Operation of Lights from the Cardan Joint ............................................................ 2-2

2.2.3 Operation Of Lights From Wall-mounted Control Box ........................................... 2-3

2.2.4 Adjusting the Pattern Size .................................................................................... 2-4

2.2.5 Positioning the Light by Sterile Personnel ............................................................. 2-4

2.2.6 Positioning the Light by Non-sterile Personnel ...................................................... 2-5

2.3 Harmony LL Lighthead Performance Data .................................................................... 2-6

3 CLEANING THE EQUIPMENT .......................................................... 3-1

3.1 Disinfecting/Cleaning/Sterilizing ................................................................................... 3-1

3.1.1 Removing the Changeable Central Handle ........................................................... 3-1

3.1.2 Disinfecting / Cleaning the Changeable Central Handle ....................................... 3-2

3.1.3 Sterilizing the Changeable Central Handle ............................................................ 3-2

3.1.4 Service Life of the Changeable Central Handle ..................................................... 3-2

3.1.5 Disinfecting/Cleaning the Cover ............................................................................ 3-2

3.1.6 Sterilize Cover as Required .................................................................................. 3-2

3.1.7 Disinfecting / Cleaning the Light ........................................................................... 3-3

4 MAINTENANCE................................................................................ 4-1

4.1 Maintenance Intervals .................................................................................................. 4-1

4.1.1 Replacing the Halogen Bulb ................................................................................. 4-2

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

129378-368 Operator Manual Table of Contents

This Page Intentionally Blank.

1-1

Listing of Warnings and Cautions Operator Manual 129378-368

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 – PERSONAL INJURY AND EQUIPMENT HAZARD:

Strictly follow this Operator’s Instruction Manual. Any use of the product requires full understanding and strict

observation of all portions of these instructions. This equipment is only to be used for the purpose specified under

Indications For Use

(see Section i). Observe all WARNINGS and CAUTIONS as rendered throughout this manual

and on labels on the equipment.

Do not use any accessory parts for Harmony LL surgical lights other than those available from STERIS.

Follow all accepted hospital procedures for disinfecting parts contaminated with body fluids (protective clothing,

eyewear, etc.).

Sterilize changeable central handle after every use.

To avoid any risk of infection, clean and disinfect Harmony LL light systems and accessories before any

maintenance according to established hospital procedures – this applies also when returning lights or parts for

repair.

Never operate a light if it has suffered physical damage or does not seem to operate properly. We recommend

that you contact STERIS Service for maintenance service for the Harmony LL surgical lights.

When servicing Harmony LL light systems, always use replacement parts that are qualified to STERIS standards.

STERIS cannot warrant or endorse the safe performance of third party replacement parts for use with Harmony LL

surgical lights.

In order to avoid burn injuries, turn power off and allow the light to cool down before servicing the light!

When changing light bulbs, inspect the lamp socket and wires for signs of scorching. If evidence of scorching

is present, notify STERIS or a factory trained and authorized service technician.

WARNING – ELECTRIC SHOCK HAZARD:

Harmony LL surgical lights are to be used only in rooms with line power installations complying with national safety

standards for hospital patient rooms (e.g., National Electrical Code¨, ANSI/NFPA 70). Always disconnect supply

before servicing.

The devices are to be used only in rooms with line power installations complying with national safety standards

for hospital patient rooms (e.g., National Electrical Code¨, ANSI/NFPA 70). Always disconnect supply before

servicing.

WARNING – EXPLOSION HAZARD:

DANGER, risk of explosion if used in the presence of flammable anesthetics. This device is neither approved nor

certified for use in areas where combustible or explosive gas mixtures are likely.

LISTING OF WARNINGS AND CAUTIONS 1

1-2

129378-368 Operator Manual Listing of Warnings and Cautions

CAUTION – POSSIBLE EQUIPMENT DAMAGE:

Restriction of Distribution: Federal Law and Regulations in the United States and Canada restrict this device to

sale by or on the order of a physician. This devices for use only in health care facilities and to be used only by

persons with specific training and experience in the use of the device.

Certain components of the Harmony LL light systems consist of materials that are sensitive to certain organic

solvents sometimes used for cleaning and disinfecting (e.g., phenols, halogen releasing compounds, oxygen

releasing compounds, strong organic acids, etc.). Exposure to such substances may cause damage that is not

always immediately apparent.

Do not put the changeable handle under mechanical stress during sterilization, as deformation of the material may

occur.

Harmony LL surgical lights must be inspected and serviced at regular intervals. A record must be kept on this

preventive maintenance. We recommend obtaining a service contract with STERIS Service. For repairs of the

device we recommend that you contact STERIS Service.

Never touch the replacement halogen bulb with your bare hands. When inserting the bulb, use the protective sleeve

provided. Failure to do so can greatly reduce the life of the halogen bulb.

Always ensure the correct lamp (determined by part number) is installed in the lighthead.

2-1

Preparation and Operation Operator Manual 129378-368

PREPARATION AND OPERATION

2.1 Preparation

CAUTION: Harmony LL surgi-

cal lights are to be used only

in rooms with line power in-

stallations complying with na-

tional safety standards for

hospital patient rooms (e.g.,

National Electrical Code¨,

ANSI/NFPA 70). Always dis-

connect supply before ser-

vicing.

CAUTION: Federal Law and

Regulations in the United

States and Canada restrict this

device to sale by or on the

order of a physician. This

device for use only in health

care facilities and to be used

only by persons with specific

training and experience in the

use of the device.

All ceiling or wall mounted Harmony LL versions are ready for immediate use

after installation.

• Sterilize changeable central handle before each procedure, see Section 3.1.

• Clean and sterilize the Harmony LL light systems according to the guidelines

shown in Section 3.

2.2 Operation

1 Attach cover vertically and push on until the audible “click” is heard, as

shown in Figure 2-1. Verify that the cover is secure.

NOTE: The cover should be sterilized before first use and as requried, see

Section 3.1.6.

Figure 2-1.

2-2

129378-368 Operator Manual Preparation and Operation

2 Slide changeable central handle onto the holder immediately before use -

until it has engaged with an audible click, as shown in Figure 2-2.

For this purpose, turn changeable handle slightly to the right or left.

NOTE: The central handle should be sterilized before each surgical procedure,

see Section 3 .1.

2.2.1 Operation The control panel can be located on either the cardan joint or a separate wall

mounted control box:

Figure 2-2.

2.2.2 Operation of Lights

from the Cardan Joint

1 The control panel is mounted on the cardan joint, not on the light itself, see

Figure 2-3.

Each light head has a separate control panel that controls the light head to

which is attached, as shown in Figure 2-4.

Figure 2-3.

Control Panel

2-3

Preparation and Operation Operator Manual 129378-368

2.2.3 Operation Of Lights

From Wall-mounted

Control Box

Wall-mounted control box are located outside the operating area and consist of

up to three control panels, depending on the amount of light heads, as shown

in Figure 2-5.

The position of the control panel corresponds to the position of the lighthead.

The top control panel is for the top light head.

NOTE: If retrofitting, cabling between the wall and the light must already be

installed, or cables will have to be routed externally.

2 key to switch the light on and off.

Upon switching on, light intensity automatically sets the illumination level to

71 % of max. level.

3 key to reduce the light intensity to 50 % in steps.

4 key to increase the light intensity to 100 % in steps.

5 Key panel for other options.

6 LEDs displaying the current light intensity setting.

7 Failure indicator of the light system monitor.

Figure 2-4.

Figure 2-5.

2-4

129378-368 Operator Manual Preparation and Operation

2.2.4 Adjusting the

Pattern Size

Figure 2-6.

• To adjust the pattern size, turn the central handle:

Counterclockwise = to increase pattern diameter

Clockwise = to decrease pattern diameter

The entire pattern size range is covered by an approx. 120° rotation of the central

handle.

2.2.5 Positioning the Light

by Sterile Personnel

• Hold the central handle and move light into the required position, as shown

in Figure 2-7.

• The central handle must be sterilized after each surgical procedure, see

Section 3.

• If the handle becomes contaminated during a procedure, replace it immedi-

ately with a clean, sterile handle.

Figure 2-7.

2-5

Preparation and Operation Operator Manual 129378-368

2.2.6 Positioning the Light

by Non-sterile Personnel

• Use the handle on the perimeter of the lighthead to move light into the required

position, as shown in Figure 2-8.

NOTE: The light is positioned by directly moving the light head. The light head

will not drift when released.

Figure 2-8.

Non-sterile

Handle

2-6

129378-368 Operator Manual Preparation and Operation

2.3 Harmony LL

Lighthead

Performance Data

Harmony LL 700 Harmony LL 500

Max. illumination intensity at 4200 K 1m distance approx. 13,471 FC (145,000 Lux) approx. 8,361 FC (90,000 Lux)

Total irradiance less than 600 W/m2 less than 320 W/m2

Uniform light field depth without refocusing approx. 27.56" (700 mm) approx. 27.56" (700 mm)

Halogen bulb lifetime 600 - 1000 h 600 - 1000 h

Illumination depth 26 - 53" 26 - 53"

(650 - 1350 mm) (650 - 1350 mm)

Pattern Size

(d 10) small light field (1 m distance) approx. 5.91" (150 mm) approx. 5.12" (130 mm)

(d 10) large light field (1 m distance) approx. 10.24" (260 mm) approx. 9.45" (240 mm)

Color temperature 4200 K ±5 % 4200 K ±3 %

Color rendition index Ra approx. 97.5 approx. 96

Color RAL 9002

Electrical installation According to NEC (ANSI/NFPA 70) and local codes.

Weight (total, including ceiling arm

and transformer) Ceiling light approx. 130 lbs. (59 kg) approx. 119 lbs. (54 kg)

Ambient conditions during operation:

Temperature +41°F to +104°F (+5°C to +40°C)

Rel. humidity <100 %

during storage:

Temperature +4°F to +158°F (-20°C to +70°C)

Rel. humidity <100 %

3-1

Cleaning the Equipment Operator Manual 119012-091

CLEANING THE EQUIPMENT

3.1 Disinfecting/

Cleaning/Sterilizing

CAUTION: Certain compo-

nents of the Harmony LL light

systems consist of materials

that are sensitive to certain

organic solvents sometimes

used for cleaning and disin-

fecting (e.g., phenols, halo-

gen releasing compounds,

oxygen releasing com-

pounds, strong organic ac-

ids, etc.). Exposure to such

substances may cause dam-

age that is not always imme-

diately apparent.

WARNING – PERSONAL IN-

JURY HAZARD: Follow all ac-

cepted hospital procedures

for disinfecting parts contami-

nated with body fluids (pro-

tective clothing, eyewear,

etc.).

WARNING – PERSONAL IN-

JURY HAZARD: Sterilize

changeable central handle

after every use.

Clean and sterilize the Harmony LL light systems according to the guidelines

below. Follow your institution’s policies regarding specific methods and agents

for cleaning and sterilization. Determination of the need and frequency of

sterilization of any particular component is the responsibility of the user

institution. Sterilization procedures should be performed according to proce-

dures established by the user institution following the specific instructions

provided by the manufacturer of the sterilizing equipment or agent to be used.

Such policies, procedures, and instructions should ultimately be consistent with

established principles of clinical microbiology and infection control.

To prevent any damage, we recommend using only detergents and disinfec-

tants that are compatible with the device, e.g. surface disinfectants based on

aldehydes, alcohols, or quarternary ammonium compounds for disinfection.

Ensure that all disinfectants are registered with the U.S. Environmental Protec-

tion Agency for use as intended. Always follow the instruction labels specifically

with respect to prescribed concentrations and the necessary exposure times.

3.1.1 Removing the

Changeable Central

Handle

After every surgical procedure

• Hold on to the body of the light.

1 While pressing push-button on the lower end of the changeable handle,

2 pull off the changeable handle.

Figure 3-1.

3-2

119012-091 Operator Manual Cleaning the Equipment

3.1.2 Disinfecting /

Cleaning the Changeable

Central Handle

After every surgical procedure

• Remove visible dirt, blood, etc. with a disinfectant and a disposable cloth.

• Clean and disinfect in a parts washer/disinfection unit.

• Prepare changeable handle for sterilization through steam autoclaving.

CAUTION: Do not put the

changeable handle under me-

chanical stress during steril-

ization, as deformation of the

material may occur.

3.1.3 Sterilizing the

Changeable Central

Handle

After every surgical operation:

sterilize at a maximum temperature of 273°F (134°C) for 5 minutes, or

at a mimumum temperature of 249.8°F (121°C) for 20 minutes in a steam

sterilizer.

• The sterilized changeable central handle should only be installed immediately

before use.

3.1.4 Service Life of the

Changeable Central

Handle

Frequent sterilization causes natural wear in reusable changeable handles.

Changeable handles must be replaced if signs of material fatigue, such as

cracking or discoloration, begin to appear.

3.1.5 Disinfecting/

Cleaning the Cover

After every surgical operation

• Wipe-disinfect the cover. There is no need to remove the cover for this

purpose.

3.1.6 Sterilize Cover as

Required

• Hold the light head,

1grasp between holder and cover and

2pull off the cover.

Sterilize the cover per the same specifications as the central handle.

Figure 3-2.

3-3

Cleaning the Equipment Operator Manual 119012-091

3.1.7 Disinfecting /

Cleaning the Light

Every day

• Wipe with a disposable cloth.

• Wipe-disinfect.

Use surface disinfectants (see Section 3.1)

For material compatibility, use only disinfectants based on:

• aldehydes

• alcohols

• quaternary ammonium compounds.

CAUTION: Certain compo-

nents of the Harmony LL light

systems consist of materials

that are sensitive to certain

organic solvents sometimes

used for cleaning and disin-

fecting (e.g., phenols, halo-

gen releasing compounds,

oxygen releasing com-

pounds, strong organic ac-

ids, etc.). Exposure to such

substances may cause dam-

age that is not always imme-

diately apparent.

3-4

119012-091 Operator Manual Cleaning the Equipment

This Page Intentionally Blank.

4-1

Maintenance Operator Manual 129378-368

MAINTENANCE

CAUTION: Harmony LL sur-

gical lights must be in-

spected and serviced at regu-

lar intervals. A record must

be kept on this preventive

maintenance. We recom-

mend obtaining a service

contract with STERIS through

your vendor. For repairs of

the device we recommend that

you contact STERIS.

WARNING – PERSONAL IN-

JURY HAZARD: To avoid any

risk of infection, clean and

disinfect Harmony LL light

systems and accessories be-

fore any maintenance accord-

ing to established hospital

procedures - this applies also

when returning lights or parts

for repair.

WARNING – PERSONAL IN-

JURY HAZARD: Never oper-

ate a light if it has suffered

physical damage or does not

seem to operate properly. We

recommend that you contact

STERIS for maintenance ser-

vice for the Harmony LL sur-

gical lights.

WARNING – PERSONAL IN-

JURY HAZARD: When servic-

ing Harmony LL light sys-

tems, always use replace-

ment parts that are qualified

to STERIS standards.

STERIS cannot warrant or en-

dorse the safe performance

of third party replacement

parts for use with Harmony

LL surgical lights.

4.1 Maintenance

Intervals

Regularly before use, but at least

every two years by STERIS or factory

trained and authorized technical ser-

vice personnel.

A service agreement with STERIS is

recommended.

Every 6 years by STERIS or factory

trained and authorized technical ser-

vice personnel.

Every 12 years by STERIS or factory

trained and authorized technical ser-

vice personnel.

Functional and visual check of the

complete light

Visual check of all cables.

General overhaul and replacement of

cables

4-2

129378-368 Operator Manual Maintenance

Figure 4-1.

A defective halogen lamp must be replaced when the fault indicator flashes

orange on the control panel.

The electronic lamp monitoring system ensures that the defective halogen lamp

is set aside and the spare lamp simultaneously moved into the focus point of

the reflector by a servo motor. At the same time, an indicator on the control panel

shows that a lamp has failed.

Only the spent lamp at the edge of the focusing unit should be replaced. If the

socket is damaged, replace lamp and socket.

• The sticker

“Attention! Hot surface!”

is found in the focusing unit.

WARNING – PERSONAL IN-

JURY HAZARD: In order to

avoid burn injuries, turn

power off and allow the light

to cool down before servic-

ing the light.

Position the light head vertically to facilitate removal of the focusing unit.

Removing the changeable central handle

• Hold the light head,

1While pressing push-button on the lower end of the changeable handle,

2pull off the changeable handle.

Figure 4-2.

4.1.1 Replacing the

Halogen Bulb

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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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