Steris Harmony La Surgical Lighting And Visualization System Operating instructions

Type
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
©2014, STERIS Corporation. All rights reserved. Printed in U.S.A.
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
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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.)
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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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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

Type
Operating instructions

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