Steris Harmony La Surgical Lighting And Visualization System Operating instructions

OPERATOR MANUAL

Harmony® Lux Advantage LA

Surgical Lighting and Visualization System

(08/10/11) P129382-106

i

129382-106

A WORD FROM STERIS CORPORATION

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.

The Harmony® Lux Advantage LA Surgical Lighting and Visualization

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.

This product may contain communication 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.

A summary of the safety precautions to be observed when operating and

servicing this equipment can be found in SECTION 1, SAFETY PRECAUTIONS.

Do not operate or service the equipment until you have become familiar with

this information.

Any alteration of the lighting system not authorized or performed by STERIS

Engineering Service which could affect its operation will void the warranty,

could violate national, state and local regulations and jeopardize your

insurance coverage.

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

Indications for Use

Advisory

ii

129382-106

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.

Equipment provided and incorporated by STERIS Corporation into

complete Optical Fiber Communication System (OFCS) satisfies applicable

laser safety requirements of the IEC 60825-1 (Class 1 Laser Product) and

IEC 60825-2 (Hazard Level 1M for OFCS).

STERIS Ltd.

Chancery House

190 Waterside Road

Hamilton Industrial Park

Leicester

LE5 1QZ

United Kingdom

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 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 LA

Surgical Lighting and Visualization System 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 LA 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 LA 500

or exceed 14,500 fc for the smallest pattern size of the Harmony LA 700

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

129382-106

TABLE OF CONTENTS

Section Title Page

1 Listing Of Safety Precautions ......................................................... 1-1

1.1 Definition of Symbols................................................................................................... 1-5

2 Installation Verification .................................................................. 2-1

2.1 Pre-operation Checklist .............................................................................................. 2-1

2.1.1 Check Suspension Movement .......................................................................... 2-2

2.1.2 Harmony LA Fiber Optic Video Enabled System ............................................... 2-2

2.1.3 Check System Operation .................................................................................. 2-4

2.1.4 Check Optional Video Camera Operation ........................................................ 2-5

2.1.5 Check Optional Monitor Support Arms ............................................................. 2-7

2.1.6 Check Optional DeepSite Lighthead ................................................................ 2-8

2.1.7 Check Optional DeepSite Ceiling-mounted Illuminator Housing ....................... 2-9

2.2 Harmony LA Optical Performance ............................................................................ 2-10

3 Operating Instructions .................................................................... 3-1

3.1 Intensity Controls ........................................................................................................ 3-1

3.2 Comparison of Lighthead Features ............................................................................ 3-3

3.3 Harmony LA 500 and 700 Lightheads Lamp Failure Indications................................ 3-4

3.4 Lighthead Positioning ................................................................................................. 3-4

3.5 Harmony LA 500 and 700 Lighthead Pattern Adjustment ......................................... 3-6

3.6 Lighthandle and Lighthandle Cover ........................................................................... 3-7

3.6.1 Installing and Using Lighthandle and Lighthandle Cover ................................. 3-7

3.6.2 Metal Sterilizable Handle .................................................................................. 3-8

3.7 Harmony LA Monitor Arms ......................................................................................... 3-8

3.8 Install Flat Panel Monitor Yoke Handle Disposable Sterile Covers ........................... 3-11

3.9 Video Camera Installation or Removal ...................................................................... 3-13

3.10 Install Camera Disposable Sterile Cover ................................................................ 3-13

3.11 Video Camera Operation ........................................................................................ 3-14

3.12 Guidelines for Maximizing Video Image ................................................................. 3-19

3.13 System Standby...................................................................................................... 3-19

3.14 DeepSite Control Center Status Indicators ............................................................. 3-20

3.15 DeepSite Lighthead Positioning ............................................................................. 3-20

3.15 DeepSite Pattern Adjustment .................................................................................. 3-21

3.17 Disposable Sterile Sleeve ....................................................................................... 3-22

3.18 Ambient Light Fixture .............................................................................................. 3-23

3.18.1 Ambient Light Operation Overview ............................................................... 3-23

3.18.2 Configuring and Using the Ambient Light ...................................................... 3-23

3.19 ACT Enabled System ............................................................................................. 3-25

. . . Continued

iv

129382-106

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 ...................................................................... 4-4

5 Operator Troubleshooting ............................................................... 5-1

6 Maintenance .................................................................................... 6-1

6.1 Preventive Maintenance Record ................................................................................. 6-1

6.2 Inspect Lampholder Module....................................................................................... 6-2

6.3 Inspect Suspension .................................................................................................... 6-2

6.4 Inspect Control Center ................................................................................................ 6-2

6.5 Reattach Lighthead Access Hood............................................................................. 6-3

6.6 Lamp Replacement: Harmony LA 500 and LA 700 Lightheads ................................ 6-4

6.6.1 Reset Harmony LA 700 Lampholder................................................................. 6-6

6.7 Lamp Replacement: Harmony LA 300 Lightheads..................................................... 6-7

6.8 Lamp Replacement: Optional DeepSite Lighthead ..................................................... 6-9

7 Replacement Parts .......................................................................... 7-1

8 Waste Disposal Guidelines ............................................................. 8-1

9 Appendix–EMC Compliance Technical Data................................... 9-1

Section Title Page

Harmony LA Surgical Lighting and Visualization System (Typical)

1-1

Operator Manual Listing of Warnings and Cautions 129382-106

The following

Safety Precautions

must be observed when operating or servicing this Harmony® LA Surgical

Lighting and Visualization 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.

NOTICE: This product contains a Class I 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 Fiber Optic connections.

WARNING – EXPLOSION HAZARD:

Do not use lighting fixture in the presence of flammable anesthetics.

This product contains materials which may require disposal through appropriately licensed and

permitted hazardous waste management firms.

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 P764330-226.)

Do not remove control center covers. Refer servicing to qualified service personnel.

Ambient light kit operates from a 100, 120, or 240 VAC power source in the ceiling. Refer any

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 – POSSIBLE PATIENT INJURY HAZARD:

Failure to engage the lighthandle cover completely may result in cover falling from lighthead during

the procedure.

WARNING – BIOHAZARD:

Sterile disposables are intended for single use only.

Universal precautions must be observed when disposing of any single use disposable item.

WARNING – PERSONAL INJURY HAZARD:

Do not attempt to replace the lamp unless lighthead is turned off and has cooled sufficiently.

LISTING OF SAFETY PRECAUTIONS 1

Continued . . .

1-2

129382-106 Listing of Warnings and Cautions Operator Manual

WARNING – PERSONAL INJURY HAZARD (Continued):

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, whether at the lamp or directly at the lighthead. Eye

injury may result.

Do not attempt to replace lamp unless the power is turned off at the control center and the lamp

module has cooled sufficiently. Lamp contains xenon gas at high pressure. Persons changing or

disposing of the lamp should wear eye protection.

Do not remove monitor-arm safety pin until monitor is installed.

Monitor extension arm must have monitor (or equivalent counterweight) installed to keep arm in

required positions while installing sliding guards.

Do not operate system unless optical fiber cables are fully connected.

To maintain Hazard Levels (1M or less) and safety measures established by STERIS end user must

Type of Max. Output

Laser Source / Channel Channels Wavelength Notes

(dBm) (mW) (nm)

SDI Transmitter +7dBm 5.01 1 1310 Sources of radiation - self-contained,

S-Video Transmitter 0dBm 1.0 1 1310 Class 1 Laser Products

VGA Transmitter +3dBm 2.0 3 1310

DVI Transmitter -3.6dBm 0.44 4 850

Table 1. System Laser Components

assure that any laser device integrated into the system and supplied by sources other than

STERIS does not exceed the optical radiation power (per wavelength) of corresponding STERIS

transmitters listed in Table 1.

It is the responsibility of the end user to ensure any device not supplied by STERIS corresponds to

the values listed in Table 1.

WARNING – IMPACT HAZARD:

Do not remove tension screw from the spring arm joint until the lighthead has been securely

installed onto the spring arm. Note: This warning applies at both installation and de-installation

procedures.

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.

1-3

Operator Manual Listing of Warnings and Cautions 129382-106

WARNING – EXPLOSION AND LACERATION HAZARD:

This lamp contains xenon gas at high pressure. Proper disposal procedures must be followed. Use

eye protection when working with these lamps.

CAUTION: POSSIBLE EQUIPMENT DAMAGE

Use of any disinfectant solution OTHER than those listed below may cause discoloration or

deformation on the lens surface: Germicidal Surface Wipes Disinfecting/Deordorizing/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.

Prevent leakage of fluids into interior of lighthead, or control center.

Avoid discoloration of control center keypad and display. Do not clean control center with

Betadine®1 solutions or allow such solutions to contact keypad and display surfaces.

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 external surfaces.

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.

To avoid damage to CRT shelf, do not exceed 75 lbs (34 kg).

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 Harmony LA System equipment.

Use of ACCESSORIES, transducers and cables other than those specified, with the exception of

transducers and cables sold by the manufacturer of the EQUIPMENT or SYSTEM as replacement

parts for internal components, may result in increased EMISSIONS or decreased IMMUNITY of the

Harmony LA System.

The Harmony LA System 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 it may affect EMC or result in equipment damage.

1. Betadine

®

is a registered trademark of Purdue Pharma L.P. Continued . . .

1-4

129382-106 Listing of Warnings and Cautions Operator Manual

CAUTION: POSSIBLE EQUIPMENT DAMAGE (Continued)

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.

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.

To avoid damage to modem chassis, load added to chassis must not exceed 4.4 lbs (2 kg).

To avoid damage to yoke assembly, load added to yoke must not exceed 22 lbs (10 kg).

1-5

Operator Manual Listing of Warnings and Cautions 129382-106

1.1 Definition of

Symbols

Symbol Definition

ON

OFF

STANDBY

Lamp Out

Protective Earth (Ground)

Do not operate system unless optical fiber

cables are fully connected.

Maximum load hazard (maximum load limit

given on label)

or Attention, consult manual for further instructions

Hot, Potential Burn 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)1

-Decrease Intensity (Surgeon's Control Buttons)1

1. Symbol is a fingertip "contour" molded into the lighthead surgeons's control bezel.

1-6

129382-106 Listing of Warnings and Cautions Operator Manual

Symbol Definition

Zoom

Rotate

Manual Focus

Auto Focus

Brightness Auto Mode

Potential Impact Hazard

Potential Pinch-Point Hazard

2-1

Operator Manual Installation Verification 129382-106

!

WARNING – ELECTRIC

SHOCK HAZARD: Do not

remove covers or perform

service other than as de-

scribed in this operator

manual. Refer servicing

to qualified service per-

sonnel (Maintenance

Manual P764330-226).

!

WARNING – IMPACT

HAZARD: Do not remove

screw from the spring arm

joint until the lighthead

has been securely in-

stalled onto the spring

arm. Note: This warning

applies at both installa-

tion and de-installation

procedures.

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.

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. (Refer to Figures 2-1

through 2-3 to locate parts.)

INSTALLATION VERIFICATION

2.1 Pre-operation

Checklist

2

Tension Screw

Figure 2-1. Tension Screw Location

for Harmony® Lux Advantage LA 500 and LA 700

Lightheads

2-2

129382-106 Installation Verification Operator Manual

Check all suspension joints for compromised integrity, such as loose fasten-

ers 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 and monitor support arms should not drift. If

binding or drifting is present in suspension movements, call your STERIS

service representative to make adjustments.

Figure 2-2. Check Suspension

Check these and all similar areas for ease of

movement, as well as suspension integrity

2.1.1 Check Suspension

Movement

!

WARNING – PINCHING

HAZARD: Pinch points are

created during extreme ar-

ticulation of the suspen-

sion system. Do not place

hands on or near the sus-

pension knuckle during

lighthead articulations.

Refer to Figure 2-3. Fiber optic flat panel monitor support arms are capable of

the following articulations: (1) rotate 270° at the secondary spindle; (2) rotate

330° at the central spindle; (3) rotate 310° at the horizontal extension arm; (4)

rotate 320° at the yoke transition; (5) move up or down by pivoting at spring

arm knuckle up to 40° up, and 40° down. Flat panel yoke also allows (6) tilt

forward (down) 15° or backward (up) 75° in yoke. The flat panel yoke can be

set for either portrait or landscape display (7).

• For additional information, refer to separate operating instructions supplied

with monitor(s). (Monitor instructions not by STERIS.)

• Power supply and input signals to monitors can be routed through the

suspension wiring from an external video source (external video sources not

provided by STERIS).

• Range of upward motion for spring arm can be adjusted to 20°, 30° or 40°

above horizontal to expand storage/parking options when monitors are not

in use.

NOTE: If weight or range of motion for flat panel monitor mount system is

changed in any way, refer to INSTALLATION INSTRUCTIONS, P129382-756

for procedures to help ensure proper balancing and motion.

2.1.2 Harmony LA Fiber

Optic Video Enabled

System

2-3

Operator Manual Installation Verification 129382-106

5

3

2

1

3

4

5

Figure 2-3. Harmony LA Monitor Arms Positioning

4

76

4

6

NOTE: For purposes of clarity, single and dual monitor arms shown without lighthead

spring arms or lightheads

Single Flat Panel Monitor Dual Flat Panel Monitor

Modem Chassis

2-4

129382-106 Installation Verification Operator Manual

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,

MAINTENANCE.

) Verify lamp-out indicator on control center display is visible.

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 (see Figure 2-5).

Figure 2-4. Use Control Center to Check System

Operation

Verify that electrical power to the control center is on.

Harmony® Lux Advantage LA Control Center:

Turn control on by pressing

“ON” touch pad. Verify that control cycles through all displays. Return to main

menu and check intensity levels for each lighthead in the system (See Figure

2-4.)

NOTE: Turn power OFF to each lighthead using intensity controls when testing

is complete.

Check Lamp Failure Indicators:

If any lamp-out graphic on the control center

display is visible, one or both of the indicated lighthead's lamps may have to

be replaced. (Refer to

SECTION 6, LAMP REPLACEMENT

.) Verify lamp failure LED on

lighthead housing is blinking.

2.1.3 Check System

Operation

2-5

Operator Manual Installation Verification 129382-106

Turn the control center ON. Install video camera in lighthandle

(see

SECTION 3.9, VIDEO CAMERA INSTALLATION OR REMOVAL

). Press the Camera

Control button on the touch pad to select the Camera Control Menu, select

and turn ON the camera. (See Figure 2-6.)

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.)

Control Center: Verify zoom, rotation and focus functions with the control

center switches. Select Camera Menu 2; verify Gain controls (if neces-

sary), verify Freeze Frame function, verify Time and Date displays (if

necessary).

Optional Wireless Hand-held Control: Verify zoom, rotation and focus

functions with the optional wireless control. (Check batteries in control if

necessary.)

NOTE: Transmitter on optional wireless control must be within 15 feet and

directed within 50° of receiver on control center.

Optional Foot Control: Verify zoom and rotation functions with the

optional foot control. (Check cable connection between foot control and

control center, if necessary.)

2.1.4 Check Optional

Video Camera Operation

Figure 2-5. Use Surgeon's Control Buttons to Check Lighthead

Intensity Operation (Harmony LA 500 Lighthead Shown)

Surgeon's

Control

Buttons

2-6

129382-106 Installation Verification Operator Manual

Figure 2-6. Camera Control Menus

CAMERA CONTROL 1 2 3 4

SLOW FAST

ZOOM SPEED

SLOW FAST

FOCUS SPEED

2-7

Operator Manual Installation Verification 129382-106

Refer to Figure 2-7.

The Harmony LA Surgical Lighting and Visualization System can include up to

two monitor arms on a single central mount. Verify smooth and easy movement

(without binding or drifting) through the monitor arm(s) ranges of articulations.

Verify that monitor, or monitors, receive video signals.

Figure 2-7. Harmony LA Monitor Support Arm

(Typical Dual Flat-Panel Monitor Arm Shown)

2.1.5 Check Optional

Monitor Support Arms

2-8

129382-106 Installation Verification Operator Manual

Refer to Figure 2-8.

Verify that DeepSite™ lighthead and arm move freely and easily through range

of articulations.

Turn lighthead ON at control center, verify intensity levels, and verify pattern

adjustment function.

Inboard Hub of

Centra Mount

Lighthead

Suspension

Knuckle

Adjustable Positioning

Gooseneck

Figure 2-8. DeepSite Lighthead and Arm

Adjustable (lower)

Suspension Arm

Spring Arm

2.1.6 Check Optional

DeepSite Lighthead

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Steris Harmony La Surgical Lighting And Visualization System Operating instructions

Steris Harmony La Surgical Lighting And Visualization System Operating instructions

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