Steris HarmonyAIR G Series User manual

OPERATOR MANUAL
HarmonyAIR™ Surgical Lighting System
G Series
(Rev. G) 10043124

i
Introduction Operator Manual 10043124
A WORD FROM STERIS CORPORATION
©2020, STERIS Corporation. All rights reserved. Printed in U.S.A.
This manual contains important information on proper use and care
of this surgical lighting system. All operators and department heads
are urged to carefully review and become familiar with the warnings,
cautions and instructions contained herein. Your new surgical
lighting fixture features an advanced, state-of-the-art design, with
cool, shadow-reduced light and ease of maneuverability. It produces
light of a quality necessary for the most demanding and complex of
surgical procedures.
A thorough preventive maintenance program is essential for safe
and proper operation of your surgical light. You are encouraged to
contact STERIS concerning our annual maintenance agreement.
Under the terms of this agreement, preventive maintenance,
adjustments and replacement of worn parts are done on a
scheduled basis to verify lighting fixture performance according to
its specifications and to help avoid untimely or costly downtime.
STERIS maintains a nationwide staff of well-equipped, factory-
trained technicians to provide this service, as well as expert repair
services. Contact STERIS for details. STERIS is also able to provide
Customer training; contact STERIS Customer Service for more
information.
Any ancillary equipment (e.g., monitors, video recorders, etc.) that is
to be used with this lighting system must comply with all applicable
medical equipment standards.
Indications for Use
The HarmonyAIR™ Surgical Lighting System G Series is a fixed or
variable pattern, variable intensity surgical lighting fixture designed
to provide visible illumination of the surgical field or the patient for
the operating room staff.
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 a 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 efficiency of the surgeon
and assistants, radiant energy can be effectively controlled by

ii
10043124 Operator Manual Introduction
limiting the time of exposure at higher illumination levels. Extra care must
be taken when the light fields from multiple lightheads are overlapped on
the surgical site, since this condition creates a risk of too much heat.
An international standard for the safety of surgical lights established by the
International Electrotechnical Commission (IEC) sets minimum and
maximum levels of illumination and maximum levels of radiant heat that
can be emitted from a single surgical luminaire. The HarmonyAIR Surgical
Lighting System G Series 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 surgical lights can be adjusted through several
intensity settings via conveniently located controls on either the wall-
mounted control center or the lighthead handle. The illumination level also
decreases as the pattern size increases. Maximum illuminance can reach
160 klx for the smallest pattern size of the lighthead and can be adjusted
by intensity control or pattern size control throughout the entire range
specified by the IEC.
Serious incidents that have occurred in relation to this medical device
should be reported to the manufacturer and competent authority in the
country where the incident occurred.
Manufactured by:
STERIS Corporation
2720 Gunter Park East
Montgomery, AL 36109 • USA
334-277-6660/800-444-9009
www.steris.com
Class 1 Equipment
Ordinary Equipment (enclosed equipment without protection from 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 Ireland Limited
IDA Business and
Technology Park
Tullamore
County Offaly
R35 X865 ■Ireland

iii
Table of Contents Operator Manual 10043124
TABLE OF CONTENTS
Section
Number Description Page
1 Safety Precautions ........................................................................................................................1-1
2 Installation Verification and technical Specifications................................................................2-1
2.1 Pre-operation Checklist .........................................................................................................................2-1
2.1.1 Check Suspension Movement .....................................................................................................2-1
2.1.2 Check System Operation.............................................................................................................2-1
2.1.3 Check Optional Video Camera Operation....................................................................................2-2
2.2 Check Optional Monitor Support Arms .................................................................................................2-2
2.3 HarmonyAIR Surgical Lighting System G5 Lighthead Optical Performance .........................................2-3
2.4 Essential Performance...........................................................................................................................2-4
2.5 Environmental Conditions......................................................................................................................2-5
2.6 Power Requirements .............................................................................................................................2-5
3 Operating Instructions..................................................................................................................3-1
3.1 Intensity Controls...................................................................................................................................3-1
3.1.1 Activate the HarmonyAIR Surgical Lighting System G Series.....................................................3-1
3.1.2 Wall Control Unit..........................................................................................................................3-2
3.1.3 Surgeon's Intensity Control Buttons.............................................................................................3-3
3.2 G5 Lighthead Module Status Indications...............................................................................................3-4
3.3 G5 Lighthead Positioning.......................................................................................................................3-5
3.4 G5 Lighthead Pattern Adjustment..........................................................................................................3-6
3.5 Lighthandles ..........................................................................................................................................3-7
3.5.1 Plastic Lighthandle and Disposable Lighthandle Cover...............................................................3-7
3.5.2 Sterilizable Surgeon Control Handle............................................................................................3-7
3.6 Monitor Arms .......................................................................................................................................3-11
3.7 Video Camera Installation or Removal ................................................................................................3-12
3.8 Install Disposable Sterile Camera Cover............................................................................................3-13
3.9 Video Camera Operation.....................................................................................................................3-13
3.10 Guidelines for Maximizing Video Image ..............................................................................................3-16
3.11 ACT Enabled System ..........................................................................................................................3-17
4 Cleaning the Equipment................................................................................................................4-1
4.1 Cleaning Equipment ..............................................................................................................................4-1
4.2 General Cleaning/Disinfecting Procedure..............................................................................................4-2
4.3 Areas To Be Cleaned Before Each Use ................................................................................................4-3
5 Operator Troubleshooting............................................................................................................5-1
5.1 Operator Troubleshooting Table............................................................................................................5-1
5.2 Wall Control Faults ................................................................................................................................5-3

iv
10043124 Operator Manual Table of Contents
Section
Number Description Page
TABLE OF CONTENTS
6 Maintenance...................................................................................................................................6-1
6.1 Preventive Maintenance ........................................................................................................................6-1
6.2 Inspect Suspension ...............................................................................................................................6-1
6.3 Inspect Wall Control...............................................................................................................................6-2
6.4 Optional Service Disconnect Switch......................................................................................................6-2
7 Replacement Parts ........................................................................................................................7-1
8 Waste Disposal Guidelines...........................................................................................................8-1
9 Appendix–EMC Compliance Technical Data..............................................................................9-1

LIST OF FIGURES
v
Table of Contents Operator Manual 10043124
Figure 3-1. Wall Control (with Optional Camera Controls)......................................................................................3-1
Figure 3-2. G5 Lighthead ........................................................................................................................................3-3
Figure 3-3. G5 Lighthead Module Status Indicator .................................................................................................3-4
Figure 3-4. G5 Lighthead Positioning......................................................................................................................3-5
Figure 3-5. G5 Lighthead Pattern Adjustment.........................................................................................................3-6
Figure 3-6. Standard Lighthandle............................................................................................................................3-9
Figure 3-7. Sterilizable Surgeon Control Handle...................................................................................................3-10
Figure 3-8. HarmonyAIR Surgical Lighting System G Series Monitor Arm...........................................................3-11
Figure 3-9. Optional Camera Installation ..............................................................................................................3-12
Figure 3-10. Install Disposable Sterile Camera Cover..........................................................................................3-13
Figure 5-1. Wall Control Fault Codes......................................................................................................................5-4
Figure 6-1. Optional Service Disconnect Switch.....................................................................................................6-2

vi
10043124 Operator Manual Table of Contents
Healthcare
Capital Equipment

viii
10043124 Operator Manual Table of Contents
LIST OF TABLES
Table Title Page
Table 1-1. Definition of Symbols..........................................................................................................................1-6
Table 2-1. HarmonyAIR Surgical Lighting System G Series Lighthead Optical Performance.............................2-3
Table 3-1. HarmonyAIR Surgical Lighting System G Series Intensity Control....................................................3-2
Table 3-2. HarmonyAIR Surgical Lighting System G Series Camera Features Summary................................3-14
Table 3-3. Brightness and Focus Mode Summary............................................................................................3-15
Table 5-1. Operator Troubleshooting ..................................................................................................................5-1
Table 7-1. HarmonyAIR Surgical Lighting System G Series Replacement Parts................................................7-1
Table 9-1. Guidance and Manufacturer’s Declaration – Electromagnetic Emissions – for all ME Equipment
and ME Systems (per IEC 60601-1-2 clause 5.2.2.1 c) Table 1).......................................................9-1
Table 9-2. Guidance and Manufacturer’s Declaration – Electromagnetic Immunity for all ME Equipment and
ME Systems........................................................................................................................................9-2
Table 9-3. Guidance and Manufacturer’s Declaration – Electromagnetic Immunity for ME Equipment and ME Sys-
tems that are not Life-Supporting .......................................................................................................9-3
Table 9-4. Recommended Separation Distances Between Portable and Mobile RF communications
Equipment and the HarmonyAIR Surgical Lighting System G Series ................................................9-4

ix
Table of Contents Operator Manual 10043124
Healthcare
Capital Equipment

1-1
Safety Precautions Operator Manual 10043124
1
The following Safety Precautions must be observed when operating or servicing this HarmonyAIR™ Surgical
Lighting System G Series. 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 utilize the unit and helps
the Customer 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.
NOTICE: This product contains a Class 1 laser product: No known biological hazard. The light is shielded from
any possible viewing by a person and the laser system is enclosed and requires a tool to access.
WARNING – PERSONAL INJURY HAZARD AND/OR EQUIPMENT DAMAGE HAZARD:
Safe and reliable operation of this equipment requires regularly scheduled preventive maintenance, in
addition to the regular performance of routine maintenance. Contact STERIS Service Engineering to
schedule preventive maintenance.
Repairs and adjustments to this equipment should be made only by fully qualified service personnel.
Maintenance performed by inexperienced, unqualified personnel or installation of unauthorized parts
could cause personal injury, invalidate the warranty or result in costly equipment damage. Contact
STERIS Service regarding service options.
Do not attempt to clean lighthead unless power is turned off and the lighthead has cooled sufficiently.
Do not attempt to adjust suspension system. Refer servicing to qualified service personnel.
Avoid looking directly at high-intensity light from the lighthead. Eye injury may result.
No part of this system shall be serviced while in use with a patient.
Flat Panel Monitor spring arm uses adjustable tension force to support monitor weight. Do not remove
monitor from the arm unless the arm has been locked in place by a trained and authorized technician.
Lighthead arm uses adjustable tension force to support lighthead weight. Do not remove lighthead from
the arm unless the arm has been locked in place by a trained and authorized technician.
Do not modify this equipment without authorization of the manufacturer.
If this equipment is modified, appropriate inspection and testing must be conducted to ensure continued
safe use of operation.
!
!
!
!
!
!
!
!
!
!
SAFETY PRECAUTIONS 1

1-2
10043124 Operator Manual Safety Precautions
WARNING – PERSONAL INJURY HAZARD AND/OR EQUIPMENT DAMAGE HAZARD
(CONTINUED):
WARNING – POSSIBLE PATIENT INJURY HAZARD:
WARNING – STERILITY ASSURANCE HAZARD:
Use of this equipment adjacent to other equipment should be avoided due to risk of improper operation of
the powered device. Observe equipment used adjacent to this equipment for proper operation prior to
use.
Portable RF communications equipment, including peripherals such as antenna cables and external
antennas, should be used no closer than 12" (305 mm) to any part of the surgical lighting system,
including cables specified by STERIS. Degradation of equipment performance could result.
Portable and mobile RF communications equipment used in close proximity to the wall control or canopy
controls units may temporarily affect the operation of the HarmonyAIR Surgical Lighting System G Series
equipment.
Use of ACCESSORIES, transducers and cables other than those specified, with the exception of
transducers and cables sold by the manufacturer of this device as replacement parts for internal
components, may result in increased EMISSIONS or decreased IMMUNITY of the HarmonyAIR Surgical
Lighting System G Series. Accessories or replacement parts not listed in the Operator or Maintenance
Manuals should not be used.
Avoid potential EMISSIONS interference. The HarmonyAIR Surgical Lighting System G Series 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 Manual or Maintenance Manual should not
be used as it may affect EMC or result in equipment damage.
Medical Electrical Equipment needs special precautions regarding EMC and needs to be installed and
put into service according to the EMC information provided in this manual.
Failure to engage the disposable lighthandle cover completely may result in cover falling from lighthead
during the procedure.
Cables or accessories other than those supplied by STERIS may affect EMC performance.
Do not use the surgeon’s control buttons when the plastic lighthandle is being used unless a disposable
sterile cover is installed. If the plastic lighthandle is used without a disposable cover, the sterility of the
surgical environment may be compromised.
Do not use disposable handle covers if the packaging has been damaged, torn or opened, as the sterility
of the cover may be compromised.
!
!
!
!
!
!
!
!
!
!
!

1-3
Safety Precautions Operator Manual 10043124
WARNING – BIOHAZARD:
WARNING – DISPOSAL HAZARD:
WARNING – SHOCK AND BURN HAZARD:
WARNING – EXPLOSION HAZARD:
WARNING – ELECTRIC SHOCK HAZARD:
WARNING – PINCHING HAZARD:
Sterile disposable covers for handles and camera are intended for single use only.
Universal precautions must be observed when disposing of any single use disposable item.
This product contains materials which may require disposal through appropriately licensed and permitted
hazardous waste management firms. The materials listed in SECTION 8 are contained within the
HarmonyAIR Surgical Lighting System G Series. When disposing of the lighting fixture or its parts,
ensure proper disposal of hazardous and other regulated waste in compliance with national, state and
local WEEE/RoHs regulations.
Disconnect all utilities to lighting fixture before servicing. Do not install the lighting fixture unless all
utilities have been properly locked out. Always follow OSHA Lockout-Tagout and electrical safety-related
work practice standards.
Do not use this lighting system in the presence of flammable anesthetics.
Do not remove covers or perform service other than as described in this operator manual. Refer servicing
to qualified service personnel.
Do not remove wall control covers. Servicing must be performed by qualified service personnel.
The OFF position on the system ON/OFF touch pad of the wall control turns off control to camera and
lightheads, but system is still energized. This mode is referred to as STANDBY, and the ON/OFF LED
flashes once per second while system is in this mode.
The ON/OFF switch under the canopy only removes power from the load side of the system. Any system
wiring located between this switch and the utility junction box is still energized.
Pinch points are created during extreme articulation of the suspension system. Do not place hands on or
near the suspension knuckle during lighthead articulations.
!
!
!
!
!
!
!
!
!
!

1-4
10043124 Operator Manual Safety Precautions
WARNING – LASER RADIATION:
CAUTION: Class 3R invisible laser radiation when canopy opened. Avoid direct eye exposure.
CAUTION: Use of controls or adjustments or performance of procedures other than those specified in
the manual may result in hazardous radiation exposure.
CAUTION: CLASS 1 LASER PRODUCT
CAUTION – POSSIBLE EQUIPMENT DAMAGE:
Appropriate components of this lighting system have been tested and found in compliance with IEC
60601-1-2: 2007, 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.
When installing or removing the video camera, be careful to place it in a secure location to prevent it from
rolling, dropping and breaking. Also, to avoid scratching the lens surface, do not stand camera up with
lens side facing down.
Use of any disinfectant solution OTHER than Coverage®Plus Germicidal Surface Wipes Disinfecting/
Deodorizing/Cleaning Wipes, Coverage®Spray HB Plus Ready-To-Use One Step Disinfectant and
Coverage®Spray TB Plus Ready-To-Use Disinfectant Cleaner may cause discoloration of the lens
surface. Other cleaning solutions 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. Staining, pitting and/
or discoloration could occur if a phenolic-based, iodophor-based, 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.
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.
DO NOT SPRAY any cleaning product directly onto the lighthead or any system components. Dampen a
soft cloth with the cleaning solution and wring out the excess moisture.
Do not use floor cleaners on this equipment.
Do not scratch the lens when cleaning; always wear rubber gloves and use only a clean, white, lint-free
cloth when wiping external surfaces.
Do not attempt to replace LED modules on the G5 lighthead. Refer servicing to qualified service
personnel.
Prevent leakage of fluids into interior of lighthead or wall control. Any such leakage could impair or
damage the lighting system.
!
!
!
!
!
!
!
!
!
!
!
!
!

1-5
Safety Precautions Operator Manual 10043124
Avoid discoloration of control center keypad and display. Do not clean control center with povidone-iodine
solutions or allow such solutions to contact keypad and display surfaces.
Do not bump lightheads into walls or other equipment.
To avoid inadequate balancing, load added to single monitor yoke must not exceed 15 kg (33 lb).
To avoid inadequate balancing, load added to dual monitor yoke must not exceed 10.5 kg (23 lb) per
monitor.
To avoid excessive radiated emissions on camera equipped systems, utilize a maximum 3’ (1 m) shielded
HDMI cable with one Fair-Rite shield bead (0446176451) and a single turn of cable at the HDMI output
and a Fair-Rite shield bead (0444164181) clamped to the distal end of the HDMI cable. Shield bead
characteristics for 0446176451 are 85 ohms at 10 MHz, 137 ohms at 25 MHz, 330 ohms at 100 MHz and
360 ohms at 250 MHz. Characteristics for 044176451 are 138 ohms at 25 MHz and 230 ohms at 100
MHz. Alternately, use a HDMI cable that has been verified to meet CISPR 11 Class A when connected to
the scaler output.
CAUTION – POSSIBLE EQUIPMENT DAMAGE: (CONTINUED)
!
!
!
!
!

1-6
10043124 Operator Manual Safety Precautions
The following symbols appear on the HarmonyAIR Surgical Lighting System G Series:
Table 1-1. Definition of Symbols
Symbol Definition
ON-OFF
Lighthead (designation and intensity)
LED Module(s) Requires Service
Protective Earth (Ground)
Attention, consult manual for further instructions
Consult instructions before use
Maximum Load Hazard (maximum load given on label)
Hot, Potential Burn Hazard
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 or Wall Control)
- Decrease Intensity (Surgeon's Control Buttons or Wall Control)
SN

1-7
Safety Precautions Operator Manual 10043124
Camera ON/OFF indicator
Zoom
Rotate
Manual Focus
Auto Mode (Brightness or Focus)
Potential Impact Hazard
Potential Pinch-Point Hazard
Brightness
Battery Backup
Fault
Table 1-1. Definition of Symbols (Continued)
Symbol Definition

1-8
10043124 Operator Manual Safety Precautions
Laser Radiation
Medical Device
Unique Device Identifier
Table 1-1. Definition of Symbols (Continued)
Symbol Definition

2-1
Installation Verification Operator Manual 10043124
Equipment Drawings showing all of the space and utility
requirements were sent to the purchaser after the order for this
surgical light was received. The clearance space shown on the
drawing is necessary for proper installation, operation and
maintenance of this fixture.
Installation and Uncrating Instructions were furnished with the
Lighting Fixture.
If any of these documents are missing or misplaced, contact
STERIS, giving the serial and model numbers of the equipment.
Replacement copies will be sent to you promptly.
2.1 Pre-operation
Checklist
Before operating the equipment, complete the pre-operation
checklist. It is essential to the safe operation and continuing
maintenance of this equipment to verify that the installation is
complete and correct.
2.1.1 Check Suspension
Movement
Check all suspension joints for compromised integrity, such as loose
fasteners or components.
❑Verify that suspension system moves through all articulations
smoothly without binding. Lightheads and monitors should move
smoothly and easily. When positioned, the lighthead support
arms (or monitor support arms) should not drift. If binding or
drifting is present in suspension movements, call your STERIS
service representative to make adjustments.
2.1.2 Check System Operation Verify that electrical power to the control center is on.
.
❑When wall control ON/OFF switch is OFF, wall control ON/OFF
LED flashes. Turn control ON by pressing wall control ON/OFF
touch pad. Verify that wall control touch pads function. Check
intensity levels for each system lighthead. If optional camera
module is installed, check camera controls.
NOTE: Turn power OFF to each lighthead using intensity
controls, and to optional camera (if installed) when testing is
complete.
❑Check Module Failure Indicators: If LED Module(s) Requires
Service graphic on wall control display is lit, one or more
modules may require service.
❑Check Module Failure LED: If the LED on any of the lightheads
is blinking, one or more LED modules may require service.
Check lighthead status LED.
❑Check Intensity Controls at Each Surgeon's Control: Verify
that the intensity level can be increased and decreased at each
lighthead using the surgeon's control buttons.
WARNING – ELECTRIC SHOCK
HAZARD: Do not remove covers
or perform service other than as
described in this operator
manual. Refer servicing to
qualified service personnel.
!
WARNING – PINCHING HAZARD:
Pinch points are created during
extreme articulation of the
suspension system. Do not place
hands on or near the suspension
knuckle during lighthead
articulations.
!
WARNING – ELECTRIC SHOCK
HAZARD: The OFF position on
the system ON/OFF touch pad of
the wall control turns OFF control
to camera and lightheads, but
system remains energized. This
mode is referred to as STANDBY,
and the ON/OFF LED flashes once
per second while system is in this
mode.
!
Module(s) Requires Service
Indicator
INSTALLATION VERIFICATION AND
TECHNICAL SPECIFICATIONS
2

2-2
10043124 Operator Manual Installation Verification
2.1.3 Check Optional Video
Camera Operation
Turn the surgical lighting system ON. Install video camera in
lighthandle (see SECTION 3.7, VIDEO CAMERA INSTALLATION OR
REMOVAL, PAGE 3-12. Press the Camera Control button on the touch
pad to turn ON the camera.
❑Video: Verify that a clear signal is reaching the video display
device (monitor) from the camera. (Check cable connection
between video output connector at control center and monitor, if
necessary.)
❑Wall Control: Verify zoom, rotation and focus functions with the
control center switches.
2.2 Check Optional
Monitor Support Arms
The HarmonyAIR Surgical Lighting System G Series can include up
to three lightheads and up to two monitor arms or Harmony®
ConnectPoint with three other arms with lightheads or flat panel
monitors.
Camera Control Button
on Wall Control