Steris Harmony LED385 Technisches Dokument

EQUIPMENT MANUAL

Harmony®LED385 Examination Lighting System

(07/20/15) P093932-203

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.

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

P093932-203 Equipment Manual Table of Contents

Healthcare

Capital Equipment

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

P093932-203 Equipment Manual Table of Contents

Healthcare

Capital Equipment

vii

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