Steris Harmony LED385 Technical Document

EQUIPMENT MANUAL
Harmony®LED385 Examination Lighting System
(07/20/15) P093932-203

i
P093932-203
A WORD FROM STERIS CORPORATION
©2015, STERIS Corporation. All rights reserved. Printed in U.S.A.
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

iv
P093932-203 Equipment Manual Table of Contents
Healthcare
Capital Equipment

v
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

vi
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
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

viii
P093932-203 Equipment Manual Table of Contents
Healthcare
Capital Equipment

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
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