Steris Harmony Led385 Examination Lighting System Operating instructions

EQUIPMENT MANUAL

Harmony® LED385 Examination Lighting System

(07/20/15) P093932-203

i

P093932-203

A WORD FROM STERIS CORPORATION

This manual contains important information on proper use and

maintenance of the Harmony® LED385 Examination 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 an examination lighting system and should be

retained in a conveniently accessible area for quick reference.

Complete instructions for uncrating and installing this equipment, as

well as an equipment drawing, have been furnished. If missing,

contact STERIS and provide the unit’s serial number and model

numbers to receive replacement copies.

Indications for Use The Harmony LED385 Examination Lighting System provides cool,

color-corrected, shadow-controlled illumination of the examination

field.

The Harmony LED385 Examination Lighting System is designed for

physician’s offices, outpatient centers, intensive care units, recovery

rooms, first aid stations and all other diagnostic specializations.

Service Information A thorough preventive maintenance program is essential to safe and

proper unit operation. This manual contains maintenance schedules

and procedures which must be followed for satisfactory equipment

performance.

You are encouraged to contact STERIS concerning our

comprehensive Preventive Maintenance Agreement. Under the

terms of this agreement, 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 nationwide staff

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

as well as expert repair services. Please contact your STERIS

representative for details.

Advisory A summary 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 a

STERIS trained technician could affect the operation of the unit, will

void the warranty and may result in the equipment being out of

compliance with applicable laws and regulations.

ii

P093932-203

EC Authorized Representative:

STERIS Ltd.

Chancery House

190 Waterside Road

Hamilton Industrial Park

Leicester LE5 1QZ

United Kingdom

STERIS Corporation

5960 Heisley Road

Mentor, OH 44060 • USA

Made in Italy

Class 1 Equipment

Type B Equipment

Ordinary Equipment (enclosed equipment without protection

against ingress of water)

Equipment not suitable for use in the presence of a

flammable anesthetic mixture with air or with 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 Corporation,

Montgomery, Alabama is an

ISO 13485 certified facility.

iii

Table of Contents Equipment Manual P093932-203

TABLE OF CONTENTS

Section

Number Description Page

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

2 Symbols and Definitions...............................................................................................................2-1

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

3.1 Before Operating Mobile Floor Stand ....................................................................................................3-1

3.2 Control Keyboard...................................................................................................................................3-1

3.3 Ceiling Mounted Version........................................................................................................................3-2

3.4 Mobile Floor Stand Version ...................................................................................................................3-3

3.5 Lighthead Positioning ............................................................................................................................3-4

3.6 Harmony LED385 Lighthead Optical Performance................................................................................3-5

3.7 Environmental Conditions......................................................................................................................3-5

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

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

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

4.3 Sterilize the Handle................................................................................................................................4-3

4.3.1 Uninstall the Handle.....................................................................................................................4-3

4.3.2 Clean the Handle .........................................................................................................................4-3

4.3.3 Disinfect the Handle.....................................................................................................................4-3

4.3.4 Sterilize the Handle......................................................................................................................4-3

4.3.5 Install the Handle .........................................................................................................................4-3

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

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

6.1 Utility Requirements...............................................................................................................................6-2

6.2 Ground Stackup.....................................................................................................................................6-3

6.3 Adjustments...........................................................................................................................................6-4

6.3.1 Adjust Spring Arm........................................................................................................................6-4

6.3.2 Adjust Braking Force....................................................................................................................6-6

7 Recommended Spare Parts List...................................................................................................7-1

8 EMC Compliance – Technical Data..............................................................................................8-1

9 Illustrated Parts Breakdown.........................................................................................................9-1

9.1 General..................................................................................................................................................9-1

9.2 How To Use The Illustrated Parts Breakdown.......................................................................................9-2

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P093932-203 Equipment Manual Table of Contents

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Capital Equipment

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Table of Contents Equipment Manual P093932-203

LIST OF FIGURES

Figure Title Page

Figure 2-1. Location of Labels ...............................................................................................................................2-2

Figure 3-1. Control Keyboard.................................................................................................................................3-1

Figure 3-2. Ceiling Mounted Version Overview......................................................................................................3-2

Figure 3-3. Mobile Floor Stand Overview ..............................................................................................................3-3

Figure 3-4. Ceiling Mounted Version .....................................................................................................................3-4

Figure 3-5. Mobile Floor Stand Version .................................................................................................................3-4

Figure 4-1. Areas to Be Cleaned (Ceiling Mounted Version).................................................................................4-4

Figure 4-2. Areas to be Cleaned (Mobile Floor Stand Version).............................................................................4-5

Figure 6-1. Ground Stackup...................................................................................................................................6-3

Figure 6-2. Adjust Swing Arm ................................................................................................................................6-5

Figure 6-3. Adjust Braking Force ...........................................................................................................................6-6

Figure 9-1. How to Use IPB Page (Typical)...........................................................................................................9-2

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P093932-203 Equipment Manual Table of Contents

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Capital Equipment

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Table of Contents Equipment Manual P093932-203

LIST OF TABLES

Table Title Page

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

Table 3-1. Harmony LED385 Lighthead Optical Performance.........................................................................3-5

Table 3-2. Transport/Storage ...........................................................................................................................3-5

Table 3-3. Installation Site................................................................................................................................3-5

Table 5-1. Operator Troubleshooting ...............................................................................................................5-2

Table 6-1. Preventive Maintenance Schedule..................................................................................................6-2

Table 7-1. Recommended Spare Parts............................................................................................................7-1

Table 8-1. Guidance and Manufacturer’s Declaration – Electromagnetic Emission.........................................8-1

Table 8-2. Guidance and Manufacturer’s Declaration – Electromagnetic Immunity.........................................8-2

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P093932-203 Equipment Manual Table of Contents

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1-1

Safety Precautions Equipment Manual P093932-203

1

The following Safety Precautions must be observed when operating or servicing this Harmony® LED385

Examination 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 use the unit safely and effectively and helps

the Customers 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:

WARNING – ELECTRIC SHOCK HAZARD:

WARNING – PERSONAL INJURY AND/OR EQUIPMENT DAMAGE HAZARD:

WARNING – EXPLOSION HAZARD:

Repairs and adjustments to the unit should be made only by trained, fully qualified personnel. Work by

inexperienced or unqualified persons or the installation of unauthorized parts could cause personal

injury, invalidate the warranty or result in costly damage.

Replace the handle if it shows cracks or deformation.

Disconnect all utilities to the examination light before servicing. Do not install the examination lighting

system unless all utilities have been properly locked out. Always follow OSHA Lockout-Tagout and

electrical safety-related work practice standards.

Verify that power to examination lighting system is off before cleaning.

Contact with damaged electrical components may result in 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 attempt to clean the lighthead unless lighthead has cooled sufficiently.

Do not use examination light in the presence of flammable anesthetics.

!

SAFETY PRECAUTIONS 1

1-2

P093932-203 Equipment Manual Safety Precautions

WARNING – ELECTROMAGNETIC COMPATIBILITY:

CAUTION – POSSIBLE EQUIPMENT DAMAGE:

This equipment/system is intended for use by healthcare professionals only. This equipment/system may

cause radio interference or may disrupt the operation of nearby equipment. If interference becomes a

concern, it may be necessary to reorient or relocate the Harmony LED385 Examination Lighting System

or shielding the location.

To prevent damaging equipment, do not use abrasive pads or cleansers. Do not spray cleaner or

disinfectant directly on equipment.

Prevent leakage of fluids into interior of lighthead, control keypad and support arm system.

Do not bump lighthead into walls or other equipment. Always use handles when positioning lighthead

during examination procedures, or when cleaning or servicing the examination lighting system.

Always follow manufacturer instructions for concentrations and use of cleaning products.

Do not use abrasive products, gasoline, paint thinners, alkaline detergents or acids.

DO NOT SPRAY any cleaning product directly onto the lighthead or any system components. Clean by

dampening a soft cloth with the cleaning solution and wring out the excess moisture.

To prevent voiding the warranty or damaging the equipment, use only STERIS replacement parts.

!

2-1

Symbols and Definitions Equipment Manual P093932-203

The following symbols appear on the Harmony® LED385 Examination Lighting System and are provided here for

reference.

Table 2-1. Symbol Definitions

Symbol Definition

Type B Equipment. Indicates the level of protection against direct and

indirect contact.

Graphic symbol providing the EC marking of the product

Symbol indicating the legal manufacturer name and address

Fuses used by the device

Danger symbol: laser beam in class II

EC Authorized Representative

Symbol indicating the date of manufacture (yyyy/mm)

Serial Number

Equipment or Reorder Number

SYMBOLS AND DEFINITIONS 2

2-2

P093932-203 Equipment Manual Symbols and Definitions

Location of Labels

Figure 2-1. Location of Labels

Serial Label (Typical) –

Ceiling Version

Serial Label (Typical) –

Mobile Floor Stand Version

Serial Label (Typical) – Lighthead

3-1

Operating Instructions Equipment Manual P093932-203

3.1 Before Operating

Mobile Floor Stand

NOTE: Mobile floor stand may tip over if it is rolled over its connecting

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

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

locking casters.

2. Check power plug and connection cable for damage.

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

socket that has been installed and grounded in accordance with

National Electric Code (NEC) and local codes.

3.2 Control Keyboard The control keyboard located on the lighthead allows the user to turn

the light on and off and to adjust the lighthead intensity (brightness)

by pressing a membrane key (or "button"). See Figure 3-1.

WARNING – ELECTRIC

SHOCK HAZARD: Contact

with damaged electrical

components may result in

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.

!

Figure 3-1. Control Keyboard

On/Off

Increase Lighthead

Intensity

Decrease Lighthead

Intensity

Three Green Positioned

Micro-LEDs

OPERATING INSTRUCTIONS 3

3-2

P093932-203 Equipment Manual Operating Instructions

3.3 Ceiling Mounted

Version

Figure 3-2. Ceiling Mounted Version Overview

Ceiling Cover

Horizontal Arm

Spring Arm

Lighthead

Sterilizable Handle

Control Keyboard

Ceiling

Anchoring

Tube

Side Handle

3-3

Operating Instructions Equipment Manual P093932-203

3.4 Mobile Floor Stand

Version

Figure 3-3. Mobile Floor Stand Overview

Lighthead

Stand

Extension

Stand

Power Supply Plug

Wheel Base

Sterilizable Handle

Control Keyboard

Spring Arm Side Handle

Side Handle

3-4

P093932-203 Equipment Manual Operating Instructions

3.5 Lighthead

Positioning

The lighthead can be positioned by using either the sterilizable

handle or side handles.

CAUTION – POSSIBLE

EQUIPMENT DAMAGE: Do not

bump lighthead into walls or

other equipment. Always use

handles when positioning

lighthead during examination

procedures, or when cleaning

or servicing the examination

lighting system.

!

Figure 3-4. Ceiling Mounted Version

Figure 3-5. Mobile Floor Stand Version

3-5

Operating Instructions Equipment Manual P093932-203

3.6 Harmony LED385

Lighthead Optical

Performance

Important: Values are typical for the highest intensity setting (unless

otherwise noted) at 39-3/8" (1 m) from the lighthead. Definitions and

measurements are in accordance with International Electrotechnical

Commission (IEC) 60601-2-41.

3.7 Environmental

Conditions

Table 3-1. Harmony LED385 Lighthead Optical Performance

Central Illuminance 4,645 fc (50,000 lux)

Pattern Size

D10 6" (152 mm)

Depth of Illumination 59" (1499 mm)

Peak Total Irradiance 119 W/m2

Color Temperature 5,000K (±10%K)

Color Rendering Index

(CRI) >90

Average Lamp Life 30,000 hours

Table 3-2. Transport/Storage

Temperature -50 to 140°F (-15 to 60°C)

Humidity 10 to 75% relative humidity,

500 to 1060 hPascals

Table 3-3. Installation Site

Temperature 50 to 104°F (10 to 40°C)

Humidity 30 to 75% relative humidity,

700 to 1060 hPascals

3-6

P093932-203 Equipment Manual Operating Instructions

Healthcare

Capital Equipment

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Steris Harmony Led385 Examination Lighting System Operating instructions

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