Steris Harmony La Surgical Lighting And Visualization System Operating instructions

INSTALLATION INSTRUCTIONS/

OPERATOR MANUAL

Harmony® Mobile Stand with

Harmony LA 500 or Harmony LED 585 Lighthead

(11/05/14) P129389-346

i

P129389-346

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 there is indication of damage to the equipment

(no matter how slight), show it to a facility supervisor.

To properly install this lighting fixture, equipment drawings

(previously furnished), are needed. Equipment drawings show all

utility service, space, and structural requirements. If these drawings

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

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

of the equipment. It is the customer's responsibility to ensure that all

structural and weight requirements for the installation and operation

of the Harmony® LED or LA (Lux Advantage) Surgical Lighting and

Visualization System are satisfied.

Once installed, equipment operation should be tested by a qualified

service technician prior to first usage of the equipment.

This equipment should only be installed by properly trained

technicians. If STERIS supervision is desired for installing and

starting up this equipment, contact STERIS.

Indications for Use The Harmony Mobile Stand with Harmony LA 500 or Harmony LED

585 lighthead is designed to provide a flexible, mobile lighting

system for various surgical and diagnostic procedures in healthcare

environments.

This product contains communications devices. A medical image

communications device provides electronic transfer of medical

image data between medical devices. It may include a physical

communications medium, modems, interfaces, and a

communications protocol.

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 the 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

ii

P129389-346

efficiency of the surgeon and assistants, radiant energy can be

effectively controlled by limiting the time of exposure at higher

illumination levels.

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 Harmony Mobile Stand with Harmony LA 500

or Harmony LED 585 lighthead 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 LED or LA

Surgical Lightheads 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 with either the Harmony LA 500 or Harmony LED 585 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

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.

The base language of this document is

ENGLISH. Any translations must be made

from the base language document

STERIS Ltd.

Chancery House

190 Waterside Road

Hamilton Industrial Park

Leicester

LE5 1QZ

United Kingdom

STERIS Corporation, Montgomery,

Alabama is an ISO 13485 certified facility.

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Table of Contents Installation/Operator Manual P129389-346

TABLE OF CONTENTS

Section

Number Description Page

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

2 Symbol Definitions........................................................................................................................2-1

3 Product Specifications..................................................................................................................3-1

3.1 Harmony Lighthead Optical Performance..............................................................................................3-1

3.2 Environmental Conditions......................................................................................................................3-3

3.3 Power Requirements .............................................................................................................................3-3

4 Installation Instructions................................................................................................................4-1

4.1 Spring Arm Assembly ............................................................................................................................4-1

4.2 Spring Arm Installation...........................................................................................................................4-2

4.3 Wire Connections ..................................................................................................................................4-3

4.4 Lighthead Installation.............................................................................................................................4-4

4.4.1 Harmony LED 585 Lighthead Installation.....................................................................................4-4

4.4.2 Harmony LA 500 Lighthead Installation.......................................................................................4-5

4.4.3 Complete Lighthead Connections................................................................................................4-6

4.5 Adjustments...........................................................................................................................................4-7

5 Installation Verification.................................................................................................................5-1

5.1 Pre-operation Checklist .........................................................................................................................5-1

5.1.1 Check Mobile Stand Suspension Movement ...............................................................................5-2

5.1.2 Check Mobile Stand Casters........................................................................................................5-3

5.1.3 Check Lighthead Operation .........................................................................................................5-3

6 Operating Instructions..................................................................................................................6-1

6.1 Install and Route Power Cord................................................................................................................6-1

6.2 Transporting the Mobile Stand...............................................................................................................6-2

6.3 Intensity Controls: Harmony LA 500 or LED 585 Lighthead..................................................................6-3

6.4 Harmony Lighthead Features ................................................................................................................6-4

6.5 Harmony Lighthead Fault Indications ....................................................................................................6-5

6.6 Harmony LA 500 or Harmony LED 585 Lighthead Positioning..............................................................6-6

6.7 Harmony Lighthead Pattern Adjustment................................................................................................6-7

6.8 Lighthandle and Lighthandle Cover.......................................................................................................6-8

6.8.1 Installing and Using Lighthandle and Lighthandle Cover.............................................................6-8

6.8.2 Metal Sterilizable Handle ...........................................................................................................6-10

6.9 Mobile Stand Positioning .....................................................................................................................6-10

7 Cleaning the Equipment................................................................................................................7-1

7.1 Cleaning Equipment ..............................................................................................................................7-1

7.2 General Cleaning/Disinfecting Procedure..............................................................................................7-2

7.3 Areas to Be Cleaned Before Each Use .................................................................................................7-4

8 Operator Troubleshooting............................................................................................................8-1

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P129389-346 Installation/Operator Manual Table of Contents

Section

Number Description Page

9 Maintenance...................................................................................................................................9-1

9.1 Inspect Harmony LA 500 Lighthead Lampholder Module......................................................................9-2

9.2 Inspect Mobile Stand.............................................................................................................................9-2

9.3 Lamp Replacement: Harmony LA500 Lightheads.................................................................................9-3

10 Replacement Parts ......................................................................................................................10-1

11 Waste Disposal Guidelines.........................................................................................................11-1

12 Appendix – EMC Compliance Technical Data...........................................................................12-1

12.1 Harmony Mobile Stand with Harmony LED 585 Surgical Lighthead....................................................12-1

12.2 Harmony Mobile Stand with Harmony LA 500 Surgical Lighthead......................................................12-5

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Table of Contents Installation/Operator Manual P129389-346

LIST OF FIGURES

Figure 4-1. Install Adapter Collar to Spring Arm ....................................................................................................4-1

Figure 4-2. Install Spring Arm to Mobile Stand ......................................................................................................4-2

Figure 4-3. Wiring Connections .............................................................................................................................4-3

Figure 4-4. Install Plug Button................................................................................................................................4-3

Figure 4-5. Install Harmony LED 585 Lighthead to Spring Arm.............................................................................4-4

Figure 4-6. Install Harmony LA 500 Lighthead to Spring Arm................................................................................4-5

Figure 4-7. Dress Wiring for Lighthead Electrical Connections..............................................................................4-6

Figure 4-8. Adjust Brake Friction and Install Pivot Cover.......................................................................................4-7

Figure 5-1. Harmony Mobile Stand for Harmony LA 500 or Harmony LED 585 Lightheads..................................5-1

Figure 5-2. Check Mobile Stand Suspension.........................................................................................................5-2

Figure 5-3. Check Mobile Stand Suspension.........................................................................................................5-3

Figure 5-4. Use Surgeon’s Control Buttons to Check Lighthead Intensity Operation............................................5-3

Figure 6-1. Install and Route Power Cord..............................................................................................................6-1

Figure 6-2. Transport Mobile Stand .......................................................................................................................6-2

Figure 6-3. Lighthead Surgeon’s Control Buttons..................................................................................................6-3

Figure 6-4. Harmony LED 585 Lighthead ..............................................................................................................6-4

Figure 6-5. Lighthead Exterior LED Indicator.........................................................................................................6-5

Figure 6-6. Lighthead Positioning ..........................................................................................................................6-6

Figure 6-7. Light Pattern Size Adjustment .............................................................................................................6-7

Figure 6-8. Standard Handle..................................................................................................................................6-9

Figure 6-9. Mobile Stand Positioning with Respect to Surgical Table..................................................................6-10

Figure 7-1. Areas to Be Cleaned ...........................................................................................................................7-3

Figure 9-1. Lamp Replacement Procedure: Harmony LA 500 Lightheads ............................................................9-4

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P129389-346 Installation/Operator Manual Table of Contents

Healthcare

Capital Equipment

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Table of Contents Installation/Operator Manual P129389-346

LIST OF TABLES

Table 2-1. Symbol Definition .............................................................................................................................2-1

Table 3-1. Harmony® LED 585 Lighthead Optical Performance.......................................................................3-1

Table 3-2. Harmony® LA 500 Lighthead Optical Performance..........................................................................3-2

Table 6-1. Harmony Lighthead Features...........................................................................................................6-4

Table 9-1. Preventive Maintenance Record......................................................................................................9-1

Table 12-1. Guidance and Manufacturer’s Declaration – Electromagnetic Emissions – for all Equipment and

Systems (per IEC 60601-2 clause 6.8.3.201 a – 3 Table 201) ......................................................12-1

Table 12-2. Guidance and Manufacturer’s Declaration – Electromagnetic Immunity for all Equipment and

Systems .........................................................................................................................................12-2

Table 12-3. Guidance and Manufacturer’s Declaration – Electromagnetic Immunity for Equipment and

Systems that are not Life-Supporting.............................................................................................12-3

Table 12-4. Recommended Separation Distances Between Portable and Mobile RF Communications

Equipment and the Harmony LED System ....................................................................................12-4

Table 12-5. Guidance and Manufacturer’s Declaration – Electromagnetic Emissions – for all Equipment and

Systems (per IEC 60601-2 clause 6.8.3.201 a – 3 Table 201a) ....................................................12-5

Table 12-6. Guidance and Manufacturer’s Declaration – Electromagnetic Immunity for all Equipment and

Systems .........................................................................................................................................12-6

Table 12-7. Guidance and Manufacturer’s Declaration – Electromagnetic Immunity for Equipment and

Systems that are not Life-Supporting.............................................................................................12-7

Table 12-8. Recommended Separation Distances Between Portable and Mobile RF Communications

Equipment and the Harmony LA System.......................................................................................12-8

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Table of Contents Installation/Operator Manual P129389-346

Healthcare

Capital Equipment

1-1

Safety Precautions Installation/Operator Manual P129389-346

1

The following Safety Precautions must be observed when operating or servicing this Harmony® Mobile Stand.

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 use the unit and helps to

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 – LACERATION/EYE INJURY HAZARD:

WARNING – LACERATION HAZARD:

WARNING – EXPLOSION HAZARD:

WARNING – ELECTRIC SHOCK AND BURN 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.

When removing bands, wear gloves to protect your hands.

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

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.

Do not remove covers or perform service other than as described in SECTION 9, MAINTENANCE of this

operator manual. Refer servicing to qualified service personnel. (MAINTENANCE MANUAL P764330-226.)

!

SAFETY PRECAUTIONS 1

1-2

P129389-346 Installation/Operator Manual Safety Precautions

WARNING – SPRING LOADED CRUSH POINT HAZARD:

WARNING – PINCHING HAZARD:

WARNING – IMPACT HAZARD:

WARNING – POSSIBLE PATIENT INJURY HAZARD:

WARNING – BIOHAZARD:

WARNING – DISPOSAL HAZARD:

Do not remove tension screw from the spring arm joint until the lighthead has been securely fastened

onto the spring arm.

Never attempt to install or remove lighthead unless tension screw is securely locked in place.

Extend the spring arm and replace the tension screw to lock the arm in the extended position whenever

removing a lighthead.

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

or near the suspension knuckle during lighthead articulations.

Do not remove tension screw from the spring arm joint until the lighthead has been securely fastened

onto the spring arm.

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

procedure.

Sterile disposables are intended for single use only. Universal precautions must be observed when

disposing of any single use disposable item.

Do not use disposable handle covers if its packaging has been damaged, torn or opened; as the

sterility of the cover may be compromised.

During surgical procedures do not use the surgeon's control buttons unless a disposable sterile cover

is installed. If the sterilizable lighthandle (metal, provided with lighthead) is used without a disposable

cover, the surgeon's control buttons are not protected by a sterile covering.

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

permitted hazardous waste management firms.

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1-3

Safety Precautions Installation/Operator Manual P129389-346

WARNING – PERSONAL INJURY HAZARD:

WARNING – TRIPPING HAZARD:

CAUTION – POSSIBLE EQUIPMENT DAMAGE:

Do not attempt to replace any LED module unless power is turned off and the lighthead has cooled.

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.

Avoid looking directly at lamp or into lighthead. Looking directly into high-intensity light may result in

eye injuries.

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

Do not remove lighthead with light arm in lowered position. Refer to MAINTENANCE MANUAL, P764330-226

for correct removal procedures.

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

area.

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

on the polycarbonate lens surface: Germicidal Surface Wipes Disinfecting/Deodorizing/Cleaning

Wipes. 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.

Secure lighthead in lower position with safety chain before transporting.

Prevent leakage of fluids into interior of lighthead. 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.

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P129389-346 Installation/Operator Manual Safety Precautions

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

60601-1-2 (2nd Edition: 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 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 that wires are not pinched between spring arms or lightheads.

The Harmony Mobile Stand with Harmony LED 585 Lighthead will come pre-assembled and calibrated.

Do not change the calibration voltage, as doing so may cause a thermal shutdown or the lighthead will

not power on. The correct voltage is written on a label under the cover beside the power supply.

Secure lighthead in lower position with safety chain before transporting.

Cleaners intended for use on floors must not be used to clean this equipment.

Avoid discoloration of control center keypad and display. Do not clean control center with Betadine®a

solutions or allow such solutions to contact keypad and display surfaces.

Cleaning and disinfecting agents used on this lighting system must be certified by their manufacturer to

be compatible with the following materials: polycarbonate, polyetherimide, santoprene.

Avoid cross-threading brake screws – align them with extreme care.

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

transducers and cables sold by STERIS as replacement parts, may result in increased emissions or

decreased immunity of the Harmony LED or LA Mobile Stands.

The Harmony LED or LA Mobile Stands should not be used adjacent to or stacked with other

equipment. 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.

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

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2-1

Symbol Definitions Installation/Operator Manual P129389-346

The following symbols appear on the Harmony® Mobile Stand with

Harmony LA 500 or Harmony LED 585 Lighthead.

Table 2-1. Symbol Definition

Symbol Definition

Protective Earth (Ground)

or

Attention, consult manual for further instructions

Hot, Potential Burn Hazard

Potential Impact 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)a

Decrease Intensity (Surgeon's Control Buttons)a

a. Symbol is a fingertip "contour" molded into the lighthead surgeons's control bezel.

✙

SYMBOL DEFINITIONS 2

2-2

P129389-346 Installation/Operator Manual Symbol Definitions

Healthcare

Capital Equipment

3-1

Product Specifications Installation/Operator Manual P129389-346

3.1 Harmony

Lighthead 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 3-1. Harmony® LED 585 Lighthead Optical Performance

Feature Harmony LED 585

Maximum Central Illuminance 160,000 Lux

Peak Total Irradiance <500 W/m2

Pattern Size Range 18 – 28 cm (7- 11")

D50 Diameter 63% of small beam pattern

(see Pattern Size Range)

Depth of Illumination (to 20%) 100 cm (39")

Depth of Illumination (to 60%) 52 cm (20")

Color Temperature (CCT) 4,400K ±300K

General Color Rendering Index

(CRI) Up to 96

Deep Saturated Red Color

Rendering Index (R9) Up to 98

Shadow Control

Single Mask 54%

Double Mask 46%

Cavity 100%

Single Mask w/ Cavity 54%

Double Mask w/ Cavity 46%

LED Life 60,000 hours for LEDs

PRODUCT SPECIFICATIONS 3

3-2

P129389-346 Installation/Operator Manual Product Specifications

Table 3-2. Harmony® LA 500 Lighthead Optical Performance

Feature Harmony

LA 500

Central

Illuminance 59,000 - 145,000 lux

(5,480 - 13,470 fc)

Pattern Size

D10 150–280 mm

(6–11")

D50/D10 > 50%

Depth of

Illumination 1,090 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: 1,200 hours

at mid-range

intensity

3-3

Product Specifications Installation/Operator Manual P129389-346

3.2 Environmental

Conditions

3.3 Power

Requirements

1.

Normal Operating

Temperature

Full System

20 to 25°C (68 to 77°F),

ambient

Transport/Storage

Temperature

(not exceeding 15 weeks)

-40°C to 70°C (-40 to 158°F),

ambient

Humidity 10% to 100% relative humidity,

500 to 1060 hPascals

Each Mobile Stand System 1 0 0 - 2 4 0 Va c

6 - 3 A

600 Watts at 100 Vac

720 Watts at 240 Vac

3-4

P129389-346 Installation/Operator Manual Product Specifications

Healthcare

Capital Equipment

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Steris Harmony La Surgical Lighting And Visualization System Operating instructions

Steris Harmony La Surgical Lighting And Visualization System Operating instructions

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