Steris Harmony Lc Surgical Lighting System Operating instructions

Brand: Steris

Model: Harmony Lc Surgical Lighting System

Type: Operating instructions

OPERATOR MANUAL

Harmony® LC500R Surgical Lighting System

(08/10/11) P129388-276

Introduction Operator Manual P129388-276

A WORD FROM STERIS CORPORATION

This manual contains important information on proper use and care

of this surgical 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 surgical

lighting fixture 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 and

complex of surgical procedures.

A thorough preventive maintenance program is essential for safe

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

contact STERIS concerning our annual maintenance agreement.

Under the terms of this agreement, preventive maintenance,

adjustments and replacement of worn parts are done on a

scheduled basis to verify lighting fixture performance according to

its specifications and to help avoid untimely or costly downtime.

STERIS maintains a nationwide staff of well-equipped, factory-

trained technicians to provide this service, as well as expert repair

services. Contact STERIS for details. STERIS is also able to provide

Customer training; contact STERIS Customer Service for more

information.

Indications for Use The Harmony® LC500R Surgical Lighting System is a variable

pattern, variable intensity surgical lighting fixture designed to

provide visible illumination of the surgical field or the patient for the

operating room staff.

Advisory 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 a 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 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. Furthermore, 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

P129388-276 Operator Manual Introduction

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.

EC Authorized Representative

STERIS Ltd.

Chancery House

190 Waterside Road

Hamilton Industrial Park

Leicester LE5 1QZ

United Kingdom

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 LC500R Surgical Lighting has been designed

to comply with this international 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 Harmony LC500R Surgical Lights can be

adjusted through several intensity settings via conveniently located

controls on 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 of the Harmony

LC500R lighthead and can be adjusted by intensity control or pattern

size control throughout the entire range specified by the IEC.

STERIS Corporation,

Montgomery, Alabama is an

ISO 13485 certified facility.

The base language of this document is

ENGLISH. Any translations must be made

from the base language document.

STERIS Surgical Technologies SAS,

Orleans, France is an

ISO 13485 certified facility.

iii

Table of Contents Operator Manual P129388-276

TABLE OF CONTENTS

Section

Number Title Page

1 Safety Precautions....................................................................................................1-1

2 Installation Verification.............................................................................................2-1

2.1 Pre-operation Checklist.............................................................................................................2-1

2.1.1 Check Suspension Movement..................................................................................................2-1

2.1.2 Check System Operation..........................................................................................................2-1

2.2 Harmony LC500R Optical Performance ...................................................................................2-2

3 Operating Instructions..............................................................................................3-1

3.1 Surgeon's Intensity Control Buttons..........................................................................................3-1

3.2 Harmony LC500R Lightheads Lamp Failure Indications ..........................................................3-2

3.3 Lighthead Positioning................................................................................................................3-3

3.4 Harmony LC500R Lighthead Pattern Adjustment.....................................................................3-4

3.5 Lighthandle and Lighthandle Cover..........................................................................................3-5

3.5.1 Installing and Using Lighthandle and Lighthandle Cover..........................................................3-5

3.5.2 Metal Sterilizable Handle..........................................................................................................3-5

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

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

4.2 General Cleaning/Disinfecting Procedure.................................................................................4-2

4.3 Areas To Be Cleaned Before Each Use ...................................................................................4-3

5 Operator Troubleshooting........................................................................................5-1

6 Maintenance...............................................................................................................6-1

6.1 Preventive Maintenance Record...............................................................................................6-1

6.2 Inspect lamp holder Module......................................................................................................6-2

6.3 Inspect Suspension...................................................................................................................6-3

6.4 Reattach Lighthead Access Hood.............................................................................................6-3

6.5 Optional Service Disconnect Switch.........................................................................................6-4

6.6 Lamp Replacement...................................................................................................................6-5

7 Replacement Parts....................................................................................................7-1

8 Waste Disposal Guidelines ......................................................................................8-1

9 Appendix–EMC Compliance Technical Data..........................................................9-1

P129388-276 Operator Manual Table of Contents

Healthcare

Capital Equipment

Table of Contents Operator Manual P129388-276

LIST OF FIGURES

Figure Title Page

Figure 3-1. Harmony LC500R Lighthead...............................................................................................................3-1

Figure 3-2. Lighthead Lamp-Failure Indicator........................................................................................................3-2

Figure 3-3. Lighthead Positioning ..........................................................................................................................3-3

Figure 3-4. Light Pattern Adjustment .....................................................................................................................3-4

Figure 3-5. Standard Lighthandle ..........................................................................................................................3-6

Figure 6-1. Reattach Lighthead Access Hood .......................................................................................................6-3

Figure 6-2. Optional Service Disconnect Switch....................................................................................................6-4

Figure 6-3. Lamp Replacement Procedure............................................................................................................6-6

P129388-276 Operator Manual Table of Contents

Healthcare

Capital Equipment

vii

Table of Contents Operator Manual P129388-276

LIST OF TABLES

Table Title Page

Table 1-1. Definition of Symbols.......................................................................................................................1-4

Table 2-1. Harmony LC500R Lighthead Optical Performance.........................................................................2-2

Table 5-1. Operator Troubleshooting ...............................................................................................................5-1

Table 6-1. Preventive Maintenance Schedule – Harmony® LC500R Surgical Lighting System ......................6-1

Table 7-1. Harmony LC500R Lighting System Replacement Parts .................................................................7-1

Table 9-1. Guidance and Manufacturer’s Declaration – Electromagnetic Emissions for All Equipment

and Systems ...................................................................................................................................9-1

Table 9-2. Guidance and Manufacturer’s Declaration – Electromagnetic Immunity for All Equipment

and Systems ...................................................................................................................................9-2

Table 9-3. Guidance and Manufacturer’s Declaration – Electromagnetic Immunity for Equipment and

Systems that are Not Life-Supporting.............................................................................................9-3

Table 9-4. Recommended Separation Distances Between Portable and Mobile RF

Communications Equipment and the Harmony LC500R System ...................................................9-4

viii

P129388-276 Operator Manual Table of Contents

Healthcare

Capital Equipment

1-1

Safety Precautions Operator Manual P129388-276

The following Safety Precautions must be observed when operating or servicing this Harmony® LC500R Surgical

Lighting System. WARNING indicates the potential for personal injury and CAUTION indicates the potential for

damage to equipment. For emphasis, certain Safety Precautions are repeated throughout the manual. It is

important to review ALL Safety Precautions before operating or servicing the unit.

Strictly following these Safety Precautions enhances your ability to safely and effectively utilize the unit and helps

the Customer avoid improper maintenance methods which may damage the unit or render it unsafe. It is

important to understand that these Safety Precautions are not exhaustive; Customers are encouraged to develop

their own safety policies and procedures to enhance and complement these Safety Precautions.

WARNING – PERSONAL INJURY HAZARD AND/OR EQUIPMENT DAMAGE HAZARD:

WARNING – POSSIBLE PATIENT INJURY HAZARD:

WARNING – STERILITY ASSURANCE HAZARD:

Safe and reliable operation of this equipment requires regularly scheduled preventive maintenance, in

addition to the regular performance of routine maintenance. Contact STERIS Service Engineering to

schedule preventive maintenance.

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 Service regarding service options.

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.

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

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

may result.

The ON/OFF switch under the canopy only removes power from the load side of the system. Any system

wiring located between this switch and the utility junction box is still energized.

Failure to ensure that the lighthandle cover is securely attached prior to the start of a procedure may

result in cover falling from lighthead during a procedure.

Do not use the surgeon’s control buttons unless an unused disposable sterile cover is in place. If the

sterilizable lighthandle (metal) is used without a disposable cover, the surgeon’s control buttons are not

protected by a sterile covering.

SAFETY PRECAUTIONS 1

1-2

P129388-276 Operator Manual Safety Precautions

WARNING – BIOHAZARD:

WARNING – SHOCK AND BURN HAZARD:

WARNING – EXPLOSION HAZARD:

WARNING – ELECTRIC SHOCK HAZARD:

WARNING – PINCHING HAZARD:

WARNING – DISPOSAL HAZARD:

CAUTION – POSSIBLE EQUIPMENT DAMAGE:

Sterile disposables are intended for single use only.

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

Disconnect all utilities to lighting fixture before servicing. Do not install the lighting fixture unless all

utilities have been properly locked out. Always follow OSHA Lockout-Tagout and electrical safety-related

work practice standards.

Do not use this lighting system in the presence of flammable anesthetics.

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

to qualified service personnel (Maintenance Manual P764333-556).

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

near the suspension knuckle during lighthead articulations.

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

hazardous waste management firms. The materials listed in Section 8 are contained within the Harmony

LC500R Surgical Lighting System. When disposing of the lighting fixture or its parts, ensure proper

disposal of hazardous and other regulated waste in compliance with national, state and local regulations.

Appropriate components of this lighting system have been tested and found in compliance with IEC

60601-1-2: 2001, 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 bump lightheads into walls or other equipment.

1-3

Safety Precautions Operator Manual P129388-276

CAUTION – POSSIBLE EQUIPMENT DAMAGE (CONT’D):

Use of any disinfectant solution on the lens surface other than Germicidal Surface Wipes Disinfecting/

Deodorizing/Cleaning Wipes may cause discoloration or deformation of the lens surface. Other cleaning

solutions 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.

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.

Prevent leakage of fluids into interior of lighthead.

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.

Use only STERIS replacement lamps in this lighting fixture. Use of lamps other than those provided by

STERIS may damage the equipment.

Portable and mobile RF communications equipment used in close proximity to the canopy power supply

enclosures may temporarily affect the operation of the Harmony LC500R System equipment.

Use of ACCESSORIES, transducers and cables other than those specified, with the exception of

transducers and cables sold by the manufacturer of the EQUIPMENT or SYSTEM as replacement parts

for internal components, may result in increased EMISSIONS or decreased IMMUNITY of the Harmony

LC500R System.

Accessories or replacement parts not listed in the Operator or Maintenance Manuals should not be used

adjacent to or stacked with the Harmony LC500R System. If adjacent or stacked use is necessary, the

equipment or system should be observed to verify normal operation in the configuration in which it will be

used.

Accessories or replacement parts not listed in the Operator or Maintenance Manuals should not be used

as they may affect EMC or result in equipment damage.

Electrical Medical Equipment may affect EMC within the surgical suite and therefore must be installed

and put into service according to the EMC information provided in this manual.

Avoid discoloration of system. Do not clean with Betadine®a solutions or allow such solutions to contact

system.

a. Betadine® is a registered trademark of Purdue Pharma, L.P.

1-4

P129388-276 Operator Manual Safety Precautions

The following symbols appear on the Harmony® LC500R Surgical Lighting System.

Table 1-1. Definition of Symbols

Symbol Definition

ON-OFF

Lighthead (designation and intensity)

Lamp Out

Protective Earth (Ground)

Attention, consult manual for further instructions

Hot, Potential Burn Hazard

SER. NO. Serial Number of Unit

V~ Voltage Rating of Unit, Alternating Current

A Amperage Rating of Unit

Hz Frequency Rating of Unit

+ Increase Intensity (Surgeon's Control Buttons)

- Decrease Intensity (Surgeon's Control Buttons)

Potential Impact Hazard

Potential Pinch-Point Hazard

1-5

Safety Precautions Operator Manual P129388-276

Brightness

Battery backup

System fault

Table 1-1. Definition of Symbols (Continued)

Symbol Definition

1-6

P129388-276 Operator Manual Safety Precautions

Healthcare

Capital Equipment

2-1

Installation Verification Operator Manual P129388-276

Equipment Drawings showing all of the space and utility

requirements were 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.

Installation and Uncrating Instructions were furnished with the

Lighting Fixture.

If any of these documents are missing or misplaced, contact

STERIS, giving the serial and model numbers of the equipment.

Replacement copies will be sent to you promptly.

2.1 Pre-operation

Checklist

Before operating the equipment, complete the pre-operation

checklist. It is essential to the safe operation and continuing

maintenance of this equipment to verify that the installation is

complete and correct.

2.1.1 Check Suspension

Movement

Check all suspension joints for compromised integrity, such as loose

fasteners or components.

❑Verify that suspension system moves through all articulations

smoothly without binding. Lightheads should move smoothly and

easily. When positioned, the lighthead support arms should not

drift. If binding or drifting is present in suspension movements,

call your STERIS service representative to make adjustments.

2.1.2 Check System Operation ❑Check Lamp Failure LED: If the LED on any of the lightheads is

blinking, one or both of the fixture’s lamps may have to be

replaced. (Refer to SECTION 6.6, LAMP REPLACEMENT, PAGE 6-5.)

Verify lamp-failure indicator on control center display is visible.

❑Check Intensity Controls at Each Surgeon's Control: Verify

that the intensity level can be increased and decreased at each

lighthead using the surgeon's control buttons. Turn OFF each

lighthead by holding - symbol until light goes out.

WARNING – ELECTRIC

SHOCK HAZARD: Do not

remove covers or

perform service other

than as described in this

operator manual. Refer

servicing to qualified

service personnel

(Maintenance Manual

P764333-556).

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.

Lamp-Failure Indicator

INSTALLATION VERIFICATION 2

2-2

P129388-276 Operator Manual Installation Verification

2.2 Harmony LC500R

Optical Performance

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

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

lighthead. Definitions and measurements are in accordance with IEC

60601-2-41

Table 2-1. Harmony LC500R Lighthead Optical Performance

Harmony LC500R

Lighthead

Central Illuminance

(range for intensity settings 1-7)

59,000–160,000 lux

(5,480–14,860 fc)

Pattern Size

D10 150–280 mm

(6–11")

D50 80–150 mm

(3–6")

Depth of Illumination 1090 mm (43")

Peak Total Irradiance < 700 W/m2

Color Temperature 4,400 K

Color Rendering Index (CRI) 94

Shadow Control

Single Mask: 31%

Double Mask: 43%

Cavity: 100%

Single mask w/ cavity: 32%

Double mask w/ cavity: 44%

Average Lamp Life:

at mid-range intensity

1,200 hrs

Operating Temperature

Non-Camera System 20°C to 24°C

(68°F to 75°F)

Storage Temperature -40°C to 70°C

(-40°F to 158°F)

Humidity 30 to 70%, non-condensing

3-1

Operating Instructions Operator Manual P129388-276

3.1 Surgeon's

Intensity Control

Buttons

Refer to Figure 3-1

1. Grasp the handle of the appropriate lighthead. A ring of

membrane buttons (bumps) are located on the control bezel

adjacent to the lighthead lens.

2. Press any of the surgeon's intensity control buttons molded with

+ symbols to increase the lighthead intensity. Press any of the

surgeon's control buttons molded with - symbols to decrease

lighthead intensity.

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

surgical procedure.

3. To turn lighthead OFF, press and hold any of the - membrane

buttons until the light goes out.

NOTE: Press the decrease intensity button (-) on the lighthead

surgeon's control for an additional two seconds to turn OFF all

lightheads in the system.

Figure 3-1. Harmony LC500R Lighthead

Lighthead Handle

OPERATING INSTRUCTIONS 3

3-2

P129388-276 Operator Manual Operating Instructions

3.2 Harmony LC500R

Lightheads Lamp

Failure Indications

Lamp status LED is located on each Harmony LC500R lighthead

(see Figure 3-2). When flashing, the lighthead LED indicates one or

both lighthead lamps should be replaced.

• Check the lamp status LED each time the surgical light is used.

• A secondary lamp inside Harmony LC500R lightheads

automatically turns on when the primary lamp fails.

• If lamp status LED is blinking, replace the failed lamp(s). (See

SECTION 6.6, LAMP REPLACEMENT, PAGE 6-5.) After lamp is

replaced, primary lamp lights, and LED indicators on lighthead

stop blinking.

Figure 3-2. Lighthead Lamp-Failure Indicator

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Steris Harmony Lc Surgical Lighting System Operating instructions

Brand: Steris

Model: Harmony Lc Surgical Lighting System

Type: Operating instructions

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Steris Harmony Lc Surgical Lighting System Operating instructions

Steris Harmony Lc Surgical Lighting System Operating instructions

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