Steris Harmony Lc Surgical Lighting System Operating instructions

Type
Operating instructions
OPERATOR MANUAL
Harmony® LC Surgical Lighting System
(08/10/11) P129388-066
i
Introduction Operator Manual P129388-066
A WORD FROM STERIS CORPORATION
©2011, 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 Harmony® LC Surgical Lighting System is a 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
P129388-066 Operator Manual Introduction
EC Authorized Representative
STERIS Ltd.
Chancery House
190 Waterside Road
Hamilton Industrial Park
Leicester
LE5 1QZ
United Kingdom
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.
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 IEC sets minimum and maximum levels of illumination and
maximum levels of radiant heat that can be emitted from a single
surgical luminaire. The LC Surgical Lighting 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 LC 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 exceed 12,000 fc for the
smallest pattern size of the Harmony LC lighthead and can be
adjusted by intensity control or pattern size control throughout the
entire range specified by the IEC.
STERIS Corporation,
Montgomery, Alabama is an
ISO 13485 certified facility.
The base language of this document is
ENGLISH. Any translations must be made
from the base language document.
iii
Table of Contents Operator Manual P129388-066
TABLE OF CONTENTS
Section
Number Description Page
1 Safety Precautions ........................................................................................................................ 1-1
2 Installation Verification ................................................................................................................. 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 Harmony LC Optical Performance ......................................................................................................... 2-3
3 Operating Instructions .................................................................................................................. 3-1
3.1 Intensity Controls ................................................................................................................................... 3-1
3.1.1 Activate the Harmony LC System ................................................................................................ 3-1
3.1.2 Harmony LC Wall Control Unit ..................................................................................................... 3-2
3.1.3 Surgeon's Intensity Control Buttons............................................................................................. 3-3
3.2 Harmony LC Lightheads Lamp Failure Indications................................................................................ 3-4
3.3 Lighthead Positioning ............................................................................................................................ 3-5
3.4 Harmony LC Lighthead Pattern Adjustment .......................................................................................... 3-6
3.5 Lighthandle and Lighthandle Cover ....................................................................................................... 3-7
3.5.1 Installing and Using Lighthandle and Lighthandle Cover ............................................................. 3-7
3.5.2 Metal Sterilizable Handle ............................................................................................................. 3-7
3.6 Harmony LC Monitor Arms .................................................................................................................... 3-9
3.7 Install Monitor Yoke Handle Disposable Sterile Covers....................................................................... 3-10
3.8 Video Camera Installation or Removal ................................................................................................ 3-10
3.9 Install Camera Disposable Sterile Cover ............................................................................................ 3-11
3.10 Video Camera Operation ..................................................................................................................... 3-12
3.11 Guidelines for Maximizing Video Image .............................................................................................. 3-14
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
P129388-066 Operator Manual Table of Contents
Section
Number Description Page
6 Maintenance................................................................................................................................... 6-1
6.1 Preventive Maintenance Record............................................................................................................ 6-1
6.2 Inspect Lampholder Module .................................................................................................................. 6-2
6.3 Inspect Suspension ............................................................................................................................... 6-3
6.4 Inspect Wall Control............................................................................................................................... 6-3
6.5 Reattach Lighthead Access Hood ......................................................................................................... 6-3
6.6 Optional Service Disconnect Switch ...................................................................................................... 6-4
6.7 Lamp Replacement................................................................................................................................ 6-5
7 Replacement Parts ........................................................................................................................ 7-1
8 Waste Disposal Guidelines........................................................................................................... 8-1
9 Appendix EMC Compliance Technical Data............................................................................. 9-1
1-1
Safety Precautions Operator Manual P129388-066
1
The following Safety Precautions must be observed when operating or servicing this Harmony® LC Surgical
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 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.
WARNING PERSONAL INJURY HAZARD AND/OR EQUIPMENT DAMAGE HAZARD:
WARNING POSSIBLE PATIENT INJURY HAZARD:
Safe and reliable operation of this equipment requires regularly scheduled preventive maintenance, in
addition to the regular performance of routine maintenance. Contact STERIS Engineering Service 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.
Do not attempt to replace the lamp unless lighthead is turned off and has cooled sufficiently.
Avoid looking directly at high-intensity light, whether at the lamp or directly at the lighthead. Eye injury
may result.
The ON/OFFswitch 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.
CRT monitor arm uses adjustable tension force to support equipment weight. Do not remove equipment
from the arm’s shelf unless the arm has been locked in place by a trained and authorized technician.
Failure to engage the lighthandle cover completely may result in cover falling from lighthead during the
procedure.
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SAFETY PRECAUTIONS 1
1-2
P129388-066 Operator Manual Safety Precautions
WARNING STERILITY ASSURANCE HAZARD:
WARNING – BIOHAZARD:
WARNING SHOCK AND BURN HAZARD:
WARNING EXPLOSION HAZARD:
WARNING ELECTRIC SHOCK HAZARD:
WARNING PINCHING HAZARD:
CAUTION POSSIBLE EQUIPMENT DAMAGE HAZARD:
Do not use the surgeon’s control buttons unless a disposable sterile cover is installed. If the sterilizable
lighthandle (metal) is used without a disposable cover, the surgeon’s control buttons are not protected by
a sterile covering.
Sterile disposables are intended for single use only.
Universal precautions must be observed when disposing of any single use disposable item.
Disconnect all utilities to lighting fixture before servicing. Do not install the lighting fixture unless all utili-
ties have been properly locked out. Always follow OSHA Lockout-Tagout and electrical safety-related
work practice standards. (See 29 CFR 1910.147 and .331 through .335.)
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. (Maintenance Manual 764332-337.)
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.
Pinch points are created during extreme articulation of the suspension system. Do not place hands on or
near the suspension knuckle during lighthead articulations.
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, do not stand camera up with lens side facing down to avoid scratch-
ing the lens surface.
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2-1
Installation Verification Operator Manual P129388-066
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 Lamp Failure Indicators: If any lamp-out graphic on wall
control display is lit, one or both indicated lighthead's lamps
may have to be replaced. (Refer to SECTION 6.7, LAMP
REPLACEMENT, PAGE 6-5.) Verify lamp failure LED on lighthead
housing is blinking.
Check Lamp Failure LED: If the LED on any of the lightheads is
blinking, one or both of the fixture’s lamps may have to be
replaced. (Refer to SECTION 6.7, LAMP REPLACEMENT, PAGE 6-5.)
Verify lamp-failure indicator on control center display is visible.
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
(Maintenance Manual
P764332-337).
!
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.
!
Lamp-Failure Indicator
INSTALLATION VERIFICATION 2
2-2
P129388-066 Operator Manual Installation Verification
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.
2.1.3 Check Optional Video
Camera Operation
Turn the wall control ON. Install video camera in lighthandle (see
SECTION 3.8, VIDEO CAMERA INSTALLATION OR REMOVAL, PAGE 3-10).
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 control center and monitor, if necessary.)
Harmony LC Wall Control: Verify zoom, rotation, and focus
functions with the control center switches.
2.2 Check Optional
Monitor Support Arms
The Harmony LC Surgical Lighting System can include up to two
monitor arms on a single central mount. Verify smooth and easy
movement (without binding) through the monitor arm(s) ranges of
articulations. Verify that monitor, or monitors, receive video signals.
Camera Control Button
on Wall Control
2-3
Installation Verification Operator Manual P129388-066
2.3 Harmony LC
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 2-1. Harmony LC Lighthead Optical Performance
Harmony LC Lighthead
Central Illuminance
(range for intensity settings 1-7)
59,000–145,000 lux
(5,480–13,470 fc)
Pattern Size
D10 150–280 mm
(6–11")
D50 80–150 mm
(3–6")
Depth of Illumination 1090 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:
at mid-range intensity
1,200 hrs
Operating Temperature
Non-Camera System
20°C to 24°C
(68°F to 75°F)
Operating Temperature
Camera System
20°C to 24°C
(68°F to 75°F)
Storage Temperature -40°C to 70°C
(-40°F to 158°F)
Humidity 30 to 70%, non-condensing
2-4
P129388-066 Operator Manual Installation Verification
Healthcare
Capital Equipment
3-1
Operating Instructions Operator Manual P129388-066
3.1 Intensity Controls The wall-mounted Harmony® LC Wall Control allows the user to
adjust the lighthead intensity level by pressing membrane switches
(or buttons). Each lighthead is capable of seven light intensity levels,
1 being the lowest intensity and 7 being the highest. An identifying
number on the control display corresponds to the same number on
the lighthead suspension arm. Additionally, each lighthead has its
own onboard intensity control located above the lighthandle
adjacent to the lens. These controls are usually referred to as the
surgeon's control buttons or as the surgeon's control (see Figure 3-
2).
3.1.1 Activate the Harmony LC
System
Refer to Figure 3-1. Press ON/OFF touch pad. This turns the system
on in active mode and restores system lightheads to same intensity
levels as before system was turned OFF.
When the system is ON, ON/OFF LED glows green and it does not
blink (i.e., is steady). This state is referred to as ACTIVE mode. When
the system ON/OFF switch is pressed while system is ACTIVE,
system switches to STANDBY mode. In STANDBY mode all lights
turn off, the optional camera module (if present) turns off, and ON/
OFF led glows green and blinks.
Intensity levels for one to three lightheads can be controlled
remotely from one wall control.
Figure 3-1. Harmony LC Wall Control
Lighthead
Intensity
Controls
Battery
Backup
Indicator
Camera
Controls
Camera
Status
Indicator
System
ON/OFF
Touch Pad
Camera
ON/OFF
Touch Pad
System
Fault
Indicator
WARNING PERSONAL INJURY
HAZARD: 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.
!
OPERATING INSTRUCTIONS 3
3-2
P129388-066 Operator Manual Operating Instructions
A given lighthead’s surgeon's control buttons adjust the intensity
level for that lighthead.
Important: Avoid control faults. Do not continuously press and
hold wall control buttons for more than 40 seconds.
3.1.2 Harmony LC Wall Control
Unit
Refer to Figure 3-1.
1. Press the selected + touch pad to activate the corresponding
lighthead.
•Pressing the + touch pad repeatedly incrementally increases
the intensity of light from the lighthead (until reaching
maximum intensity).
•Pressing the - repeatedly reduces light intensity until
reaching a minimum level. Continuing to press - (for 2
seconds) at any intensity level causes the lighthead to shut
off. (Pressing that lightheads + button restores light to the
lighthead at previous level.) Refer to Table 3-1 for a
summary of wall control intensity functions.
2. Once the lighthead is selected, press either the button to
increase light intensity level (+), or the button to decrease light
intensity level (-).
WARNING – EXPLOSION
HAZARD: Do not use this lighting
system in the presence of
flammable anesthetics.
!
Table 3-1. Lamp Intensity Control
Lamp
State
Lamp
Intensity
Switch
Pressed
Duration of
Switch Press Operation
OFF N/A + Any Lamp turns ON at stored intensity setting
ON Any
except
highest
+Any
Lamp increases to next higher intensity
setting
ON Highest + Any Lamp remains at highest intensity setting
OFF N/A - Any Lamp remains OFF
ON Lowest - Less than 2 sec-
onds Lamp remains at lowest intensity setting
ON Lowest - 2 seconds or lon-
ger
Lamp initially remains at lowest intensity
setting and after two seconds the lamp
turns OFF
ON Any
except
lowest
- Less than 2 sec-
onds Lamp decreases to next lower intensity
setting
ON Any
except
lowest
- 2 seconds or lon-
ger
Lamp initially decreases to next lower
intensity setting and after two seconds the
lamp turns OFF
3-3
Operating Instructions Operator Manual P129388-066
3. At the wall control press and hold the - button until the light goes
out.
NOTE: For longer lamp life, use lowest intensity level suitable for
surgical procedure.
3.1.3 Surgeon's Intensity
Control Buttons
Refer to Figure 3-2
1. Grasp the handle of the appropriate lighthead. A ring of
membrane buttons (bumps) are located on the control bezel
adjacent to the lighthead lens.
2. Press any of the surgeon's intensity control buttons molded with
+ symbols to increase the lighthead intensity. Press any of the
surgeon's control buttons molded with - symbols to decrease
lighthead intensity.
NOTE: For longer lamp life, use lowest intensity level suitable for
surgical procedure.
Either Any Either 40 seconds or
longer
Switch Fault: Depending upon the
switch pressed and the initial conditions of
the lamp state and intensity, the control of
the lamp follows one of the sequences
listed above. After 40 seconds, the switch
is disabled. All other switches remains
operational. Full control of lamp intensity
remains available at the lighthead user
interface.
Table 3-1. Lamp Intensity Control (Continued)
Lamp
State
Lamp
Intensity
Switch
Pressed
Duration of
Switch Press Operation
Figure 3-2. Harmony LC Lighthead
3-4
P129388-066 Operator Manual Operating Instructions
3. To turn lighthead OFF, press and hold any of the - membrane
buttons until the light goes out.
NOTE: Press the decrease intensity button (-) on the lighthead
surgeon's control for an additional two seconds, to turn OFF all
lightheads in the system.
3.2 Harmony LC
Lightheads Lamp
Failure Indications
LEDs on the wall control indicate lamp status. If the wall control lamp
status LED is lit, it indicates the primary lamp or the secondary lamp
(or perhaps both), have failed. A failed lamp should always be
changed at the earliest opportunity.
Another lamp status LED is located on each Harmony LC lighthead
(see Figure 3-3). When flashing, the lighthead LED indicates one or
both lighthead lamps should be replaced.
Check the lamp status LED each time the surgical light is used.
A secondary lamp inside Harmony LC lightheads automatically
turns on when the primary lamp fails.
If either lamp status LED is blinking, replace the failed lamp(s).
(See SECTION 6.7, LAMP REPLACEMENT, PAGE 6-5.) After lamp is
replaced, primary lamp lights, and LED indicators on lighthead
and wall control stop blinking.
Figure 3-3. Lighthead Lamp-
Failure Indicator
3-5
Operating Instructions Operator Manual P129388-066
3.3 Lighthead
Positioning
Lightheads can be positioned by using either the sterile handle, or
by grasping the non-sterile handle around the lighthead housing.
Each lighthead can be positioned as listed from outside or from
within the sterile field. To optimize shadow control, position the
lighthead as appropriate before starting the intended surgical
procedure.
Harmony LC Lighthead/Spring Arm Assemblies may:
See Figure 3-4.
1. Rotate continuously around central hub;
2. Rotate continuously at horizontal suspension arm/ spring arm
connection;
3. Rotate continuously at spring arm/yoke connection;
4. Rotate at the dual cardanic yoke hub 270°;
5. Tilt forward or backward in yoke approximately 300°; and
6. Move up or down by pivoting at suspension elbow 45° up, and
50° down (total range: 95°).
Figure 3-4. Lighthead Positioning
1
2
3
4
6
5
3-6
P129388-066 Operator Manual Operating Instructions
3.4 Harmony LC
Lighthead Pattern
Adjustment
The illumination pattern for Harmony LC lightheads can be adjusted
to any size between the maximum diameter and minimum diameter.
Refer to Figure 3-5.
Adjust the light pattern by rotating the lighthandle clockwise to
decrease pattern size.
Rotate the handle counterclockwise to increase pattern size.
NOTE: Typical lighthead positioning is above and slightly behind
the surgeon's right or left shoulder.
CAUTION POSSIBLE
EQUIPMENT DAMAGE HAZARD:
Do not bump lightheads into walls
or other equipment.
!
Figure 3-5. Light Pattern Adjustment
Rotate Handle to
Decrease Pattern
Size
Rotate Handle to
Increase Pattern
Size
3-7
Operating Instructions Operator Manual P129388-066
3.5 Lighthandle and
Lighthandle Cover
Lighthandles are used to position Harmony LC lightheads, allow
access to intensity control on each lighthead, and to adjust lighthead
pattern size. To avoid accidental contact with the non-sterile
surgeon's control buttons, the lighthandle should always be used
with a disposable, sterile lighthandle cover (available separately
from STERIS).
If the lighthandle adapter is not already in place, align the tab on
the adapter with the channel in the mounting ring and thread the
adapter in until fully engaged. (See Figure 3-6.)
NOTE: The Harmony LC lighthead does not have a separate
adapter. Adapter is permanently integrated into lighthandle
assembly.
Prior to starting a procedure, ensure that the lighthandle is in place.
Install the lighthandle by threading onto the adapter and firmly
tightening (see Figure 3-6).
Remove the sterile lighthandle cover from its packaging and
install onto the lighthandle (see Figure 3-6).
To ensure the lighthandle cover remains in place during the
procedure, the groove in the cover must be fully engaged with
the groove in the lighthandle.
The lighthandle can be removed for cleaning or sterilization by
unscrewing it from the handle adapter. The lighthandle can be
sterilized using standard hospital cycles. Do not use the
lighthead during a sterile procedure unless a disposable cover is
installed on the lighthandle.
3.5.1 Installing and Using
Lighthandle and Lighthandle
Cover
The metal sterilizable handle is used to position the Harmony LC
lighthead and to adjust the light pattern size. The sterilizable handle
may be used in place of a disposable sterile lighthandle cover.
The plastic lighthandle should be removed prior to installing the
metal sterilizable handle. To do so, simply unscrew it from the
threaded handle adapter.
3.5.2 Metal Sterilizable Handle Prior to starting a procedure, install a clean, sterilized metal handle
by screwing it onto the threaded handle adapter. Ensure handle is
firmly tightened prior to use. The gap between the flange on the
metal sterilizable handle and the surgeon's control buttons prevent
accidental contact with the non-sterile surface of the buttons.
The metal sterilizable handle can be removed for sterilization by
unscrewing it from the adapter.
The metal sterilizable handle can be sterilized using standard
hospital steam cycles intended for lumens. Always sterilize handle
between surgical procedures.
WARNING POSSIBLE PATIENT
INJURY HAZARD: Failure to
engage the lighthandle cover
completely may result in cover
falling from lighthead during the
procedure.
!
WARNING STERILITY
ASSURANCE HAZARD: Do not
use the surgeon’s control buttons
unless a disposable sterile cover
is installed. If the sterilizable
lighthandle (metal) is used
without a disposable cover, the
surgeon’s control buttons are not
protected by a sterile covering.
!
3-8
P129388-066 Operator Manual Operating Instructions
Figure 3-6. Standard Lighthandle
Lighthandle Adapter
Surgeon’s Intensity
Control Buttons
Align Tab on Handle
Adapter with Channel
in Mounting Ring
Lighthandle Adapter
Lighthandle
Push Cover
Completely onto
Lighthandle
Install Disposable Cover Immediately Before
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Steris Harmony Lc Surgical Lighting System Operating instructions

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