Zibra corp ZC-LS006-1002 User manual

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This device is covered under US Patents issued and pending.
Handheld LED Light Source (HLS)
Operator’s Manual
Sales and Service by:
Zibra Corp
640 American Legion Hwy
Westport, MA 02790 USA
USA Tel: [phone]
www.zibracorp.com

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USA Tel: [phone]
www.zibracorp.com
Table of Contents Page
1. Introduction ............................................................................................................................ 4
Summary ................................................................................................................................ 4
Safety Measures...................................................................................................................... 4
2. HLS Features, Specifications & Accessories ...................................................................... 5
Light Source Features …………….......................................................................................... 5
Specifications ......................................................................................................................... 6
Accessories ............................................................................................................................ 6
3. HLS Function and Operation ................................................................................................ 7
Light Source Preparation ........................................................................................................ 7
Light Source Operation ........................................................................................................... 7
Battery and Charger ............................................................................................................. 8, 9
4. Care & Maintenance .............................................................................................................. 10
I - Methods of Light Source Disinfecting .................................................................................. 10
II –Light Source Disinfecting Protocol..................................................................................... 10
1 Pre-Cleaning.............................................................................................................. 10
2 Enzymatic Cleaning and Rinsing ............................................................................... 10
3 High-Level Disinfection .............................................................................................. 11
III –Drying the Light Source ................................................................................................... 11
IV –Preventative Maintenance.……………………………………………………………….… 11, 12
5. Troubleshooting ................................................................................................................... 12
6. Agency Compliance Statements and Guidance ………..................................................... 13
Guidance and Manufacturer’s Declaration – Emissions ......................................................... 13
Guidance and Manufacturer’s Declaration – Immunity ........................................................... 13
Recommended Separation Distance between Portable and Mobile RF
Communications Equipment ............................................................................................. 14
7. Repair Service ....................................................................................................................... 14
8. Warranty ................................................................................................................................. 14
9. Symbol Descriptions ............................................................................................................. 14
WARNING: This device is not supplied sterile. Clean and disinfect the device prior to use by
employing the procedures listed in this manual.
WARNING: This equipment is not suitable for use in the presence of flammable mixtures.
WARNING: the following methods of disinfection will result in damage to the light source and
should not be used: Ethylene Oxide, autoclave, ultrasonic, chlorides, formaldehyde, and
hydrogen peroxide.
WARNING: In order to avoid potential safety hazards, the user of this device should consult
the manuals of all Electrical Equipment used in conjunction with this device. If this device is
used with High Frequency Equipment, the attached endoscope should be approved for use
with High Frequency Equipment, and the user should consult the manuals of all devices for
safe operating voltage levels.

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1. Introduction
Summary
The Zibra Handheld Light Source (HLS) provides superior LED illumination for endoscopes, borescopes,
video scopes, veterinary and dental examination applications. Patent pending optics collect more light from
the LED, for a highly efficient light source. The Zibra HLS replaces fiber-optic light-guide cables or wires
common to traditional light sources of the past. Enhanced mobility, ease of use, brightness and quality of
light are achieved with this device. It uses a powerful, best-in-class LED, cooled by a comfortable, finned
handle. An easy to grip intensity knob provides precise adjustments of light output and a quick-change
battery. Internal circuitry protects against accidental reverse polarity, should the battery be inserted in the
wrong orientation, and maintains constant current to the LED as the battery voltage drops with use, for more
consistent light output. A long life LED eliminates lamp replacement and requires no fan, providing a silent
and energy efficient light source which is lightweight, compact and portable.
Please be sure to handle this optical instrument with care at all times. The electrical and optical components
can be damaged by physical abuse, extreme temperatures, or fluid invasion into the light source.
IMPORTANT: This instrument is intended for use by persons thoroughly trained in the
techniques that employ this light source, such as endoscopy.
WARNING: Avoid direct viewing of the high intensity light at the front of the Handheld Light
Source. Never point it’s light at other’s.
This manual describes the proper procedures for using the light source. The manual also contains pertinent
information on the proper care and handling of the light source during use, disinfecting and storage.
Please read this entire manual carefully before using the light source. If you have any questions concerning
the material contained in this manual or the operation or safety of the equipment, please contact Zibra.
Safety Measures
•Never look directly into the light source when it is on. Point its light away from others.
•Read this Owner’s Manual first. Improper use may damage the light source.
•Check all items upon receipt to assure damage has not occurred during shipment.
•Verify compatibility of all scopes and accessories attaching to the HLS by contacting Zibra.
•Avoid storing or charging the HLS in areas of heavy traffic to prevent accidental physical damage.
•Do not disassemble the HLS. There are no user-serviceable parts. Disassembly voids all warranties.
•Avoid immersing the light source for periods of time greater than recommended by the disinfectant
manufacturer. Prolonged immersion may damage the exterior of the light source and could result in
fluid invasion into the light source.
•Prior to use, check the outer surface of the light source, endoscope and any endoscopically-used
accessories for rough surfaces, sharp edges, burrs or protrusions that may cause a safety hazard.

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2. HLS Features, Specifications & Accessories
Light Source Features
Figure 1. Handheld Light Source Diagram
Scope Adapter
Specified at time of purchase, the Scope Adapter allows the Handheld Light Source to attach to the user’s
endoscope. Three configurations of the Zibra HLS are available:
➢UNIV: A Universal adapter that threads onto the standard light guide post’s Storz adapter thread.
Rotate the HLS clockwise to attach to an endoscope and counterclockwise to remove it.
➢ACMI: An adapter for the snap-in quick-connect ACMI light guide post.
➢WOLF: An adapter for the snap-in quick-connect Wolf light guide post.
Power Module
The battery can be removed and replaced for recharging. Rotating the control to the Off position (0) will allow
the Power Module to be pulled out. An o-ring seals the battery and electronics when the Power Module is
inserted into the Heatsink/Handle.
➢On/Off Switch: The On/Off switch turns the LED on/off at the “0” position.
➢Intensity Control Knob: The knob will increase/decrease the light intensity of the HLS.
oRotate the control towards the larger numbers of the intensity scale to turn the light source
on and increase the light intensity.
oRotate the control to the zero end of the intensity scale to gradually decrease the light
intensity and turn the light source off. Notice a click-in at both the off (0) and maximum (10)
positions.
➢Battery Compartment: Remove and Replace battery.
oSee section 3 –HLS Function and Operation for complete details.
Light Intensity
➢Indicator Dot
➢Scale
Scope Adapter
➢UNIV
➢ACMI
➢WOLF
Power Module
➢On/Off Switch
➢Intensity Control Knob
➢Battery Compartment

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Specifications
Parameter
Specification
Body Diameter
32mm [1.28 in]
Overall Length
103mm [4.06 in]
Weight (with battery)
137g [4.8oz]
Battery Life at Full LED Power
~ 45 minutes
Battery Charge Time
~ 2 hours
Battery Type
RCR123A (16340) Protected Lithium Ion
3.7V, 800mAHr minimum
Power Source
Internal Battery Power
Mode of Operation
Continuous , Adjustable Light Output
Safe Operating Ambient Temperature Range
15 –33ºC [59 - 91°F]
Safe Storage and Transport Temperature Range
-25 –50ºC [-13 - 122°F]
Safe Operating, Storage, and Transport Relative
Humidity Range
0 –95% RH
Battery Recharge Cycles
~ 500 recharges
RoHs Compliant
Yes
Accessories
Light Sources & Accessories Listing
Part Number
Handheld Light Source Kit with Universal Adapter
LS006-UNIV
Handheld Light Source kit with ACMI Adapter
LS006-ACMI
Handheld Light Source kit with Wolf Adapter
LS006-WOLF
Rechargeable Battery type RCR123A (16340)
BT003-0079
Battery Charger Cradle
BT003-0080
Battery Charger AC/DC Adapter (US Plug)
BT003-0081
Battery Charger AC/DC Adapter (European Plug)
BT003-0082
Battery Charger AC/DC Adapter (UK Plug)
BT003-0083
Operator’s Manual
LS006-0057
Shipping Box
LS003-0058
USA Tel: [phone]
www.Zibracorp.com

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3. HLS Function and Operation
Light Source Preparation
➢Before use, the light source should be reprocessed. Please refer to the Care & Maintenance
Section of this manual for proper disinfecting protocol.
Light Source Operation
NOTE: The
endoscope may
have included
adapters that
are supplied
attached to the
light post prior
to shipping.
Unthread any
adapters prior to
attaching the
HLS. (see
Figure 8)
Figure 2. Attaching the Handheld Light Source to a rigid scope
➢Universal: Insert the light guide post of the endoscope into the Universal Scope Adapter and
rotate the HLS clockwise until it is “finger-tight”. Do not over-tighten.
➢ACMI or Wolf: Insert the light guide post of the endoscope into the Scope Adapter until it snaps
into place. It is normal for a small amount of play to exist between the endoscope and HLS.
Figure 3. Adjusting Light Intensity
Turn the light source on by rotating the light intensity control knob towards the 1-10 numbers of the intensity
scale. Adjust the brightness to the desired level by rotating the intensity knob further.
Turn the light source off by rotating the intensity control knob to the zero mark (0) of the intensity scale.
➢Avoid leaving the light source on for extended periods of time when not in use, as this will drain
the battery unnecessarily.
Pointer on Knob
Intensity Control Knob
- Rotate to Adjust -
On / Off
Indicator
Mark
Intensity Scale

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Battery and Charger
Figure 4. Removing the Power Module and inserting and removing the Li-Ion Battery
The HLS’s internal LED light source operates on a single, Lithium-ion battery and provides approximately 45
minutes of continuous operation with a fully-charged new battery. Use only Protected RCR123A (16340)
Lithium Ion (Li-ion) 3.7V Button Top Battery. This type of battery provides important internal PCB protection
against: Over-Discharge, Over-Charge & Short Circuit, which otherwise could be hazardous.
To insert a new battery, turn HLS to off position and pull Power Module out from the Heatsink/Handle, then
remove the old and install a new battery in the Battery Sled, making sure the “+” end of the battery is inserted
in the correct orientation. Once a charged battery is inserted into the Power Module, reinstall the Power
Module by carefully aligning the key on the bottom of the Battery Sled with the keyway cut in the
Heatsink/Handle. NOTE: The key must be aligned with the keyway before full insertion is possible.
Please take care not to let the battery fall to the floor or onto a hard object, which could damage the battery.
CAUTION:
•Do not puncture or incinerate the battery. Contains explosive/flammable material.
•Do not expose the battery to high temperatures above 122ºF/50ºC
•Do not disassemble or short circuit the battery
•Do not use a damaged or leaking battery.
WARNING: The battery should be removed if the equipment is not likely to
be used for some time. Store battery in a cool dry location out of direct
sunlight.
Do not discard Li-ion Batteries in the trash, they must be sent to a recycling center. See
www.call2recycle.org or call 1-877-2-RECYCLE for the nearest drop-off location. This non-
profit Organization has over 30,000 drop-offs in North America.
Power Module
Battery Sled
Key is on the bottom
of the Battery Sled

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Figure 5. Battery Charger, AC Adaptor, and two Batteries
Charging a Battery
1. Plug the AC adapter into an AC outlet first, then plug the AC adapter’s wire into the charger.
➢The LED above each battery will change color to indicate charging status.
2. Insert one or two batteries into the charger. Match +/- polarity as marked on battery and charger.
➢A solid RED LED indicates the battery is charging.
➢A solid GREEN LED indicates the battery is fully charged or no battery is present.
3. After the battery is fully charged, pull the battery(s) out of the charger.
4. Unplug the AC adapter when not in use to conserve energy.
CAUTION:
•Never expose the charger to water or moisture; do not use if wet.
•Charge batteries on a fire-proof surface and away from flammables.
•Do not disassemble the charger; there are no user-serviceable parts inside.
•Follow local regulations for disposal of electrical components or batteries (page 7).
WARNING: The battery charger is not a medical device.
Battery
Charger
Cradle
AC Adaptor
Select from:
•US
•UK
•EU
Battery Status LEDs

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4. Care and Maintenance
I –Method of Light Source Disinfecting
WARNING: Do not use: Ethylene Oxide, autoclave, ultrasonic, chlorides, formaldehyde, or
hydrogen peroxide. Using any of these may damage the light source and will void the product
warranty.
The HLS is sealed for protection against ingress of fluids only when assembled. The entire light source is
submersible in water and disinfectant solutions. However, the light source should not remain immersed in
water or cleaning solutions for prolonged periods of time. After the disinfection cycle has concluded, remove
the light source from the disinfection solution, dry and store it in a clean and dry environment.
A thorough cleaning and rinsing are the first and most important steps in disinfecting this light source. Without
a thorough cleaning and rinsing, it may not be possible to achieve high-level disinfection. Cleaning is the
removal of all adherent visible soil (i.e. blood, protein substances and/or other debris) from the surface,
crevices and joints of the light source.
Use caution when cleaning and disinfecting as some methods may be harmful to the light source and could
result in extensive damage. Manual cleaning is the recommended method for cleaning the light source. To be
effective, cleaning agents must assist in the removal of residual organic debris without damaging the device.
No single cleaning agent removes all types of debris or is safe to use with every type of reusable device.
Certain cleaning agents may damage the device’s materials. Cleaning agents should be used in the correct
dilution/concentration and at the correct temperature in accordance with the cleaning agent manufacturer’s
directions. Please contact Zibra Corp at 1-800-758-8773 to verify the compatibility of a cleaning method not
listed below under Section II - Light Source Disinfecting Protocol.
WARNING: Remove battery prior to disinfecting. Ensure Power Module is fully inserted on the
Heatsink, so that the o-ring seal will prevent liquid intrusion into the battery compartment.
WARNING: With battery removed, rotate Intensity Control Knob until it clicks into the maximum
brightness setting of 10, thereby preventing accidental separation while handling.
II - Light Source Disinfecting Protocol
1. Pre-Cleaning with detergent
2. Enzymatic Cleaning and Rinsing; Enzol Fast Acting Enzymatic Cleaner or equivalent
3. High-Level Disinfection with CIDEX OPA (0.55% ortho-Phthalaldehyde Solution)
Pre-Cleaning
Zibra recommends the light source be pre-cleaned immediately after the device has become contaminated.
This will prevent patient material from adhering to the light source. Dried material is difficult to remove and
can render the disinfection process ineffective. Gently wipe all debris from the exterior surfaces using a soft,
lint-free cloth and water to which you have added a low sudsing detergent, diluted in accordance with the
detergent manufacturer’s instructions.

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Enzymatic Cleaning and Rinsing
1. Fill a basin with a freshly made solution of water and a low sudsing detergent, diluted in accordance
with the detergent manufacturer’s instructions.
2. With battery removed and Intensity Control Knob set to 10, Immerse the light source in solution.
3. Wash all debris from the exterior of the light source by gently brushing and wiping the instrument
while submerged in the detergent solution.
4. Rinse the light source in clean water.
5. Wipe dry the exterior of the light source with a soft, clean cloth.
High-Level Disinfection with CIDEX OPA (0.55% ortho-Phthalaldehyde Solution)
1. Prepare the disinfectant solution in accordance with the solution manufacturer’s label.
2. Remove battery and set Intensity Control knob to 10, to prevent separation while handling.
3. Completely immerse the light source in the disinfectant solution for the recommended time and
temperature as indicated on the label of the disinfectant.
4. Thoroughly rinse the exterior of the light source with large amounts of clean water. NOTE: “It is
suggested that all rinsing after disinfection should be done with water that has been filtered by
passage through a 0.2 micron filter or otherwise treated by a method documented to improve the
microbiological quality of water.” ASTM F 1518
5. A final rinse using 70% isopropyl alcohol solution can be used to speed the drying process and
reduce the numbers of any organisms present as a result of rinsing with potable water.
6. Dry the exterior of the light source with a soft, clean towel.
III - Drying the Light Source
After the HLS becomes wet, either from water or cleaning fluids, thoroughly dry the exterior immediately.
Rinse with isopropyl alcohol, followed by drying with a compressed gas. Use of compressed air or commercial
compressed gas canisters is highly recommended to reduce contamination of the window, and to reduce the
possibility of oxidation of other materials used in the construction of the light source.
WARNING: Do not permit the light source to remain in cleaning or disinfectant solutions longer
than the manufacturer’s recommended treatment time. Do not permit the light source to remain in
any liquids or remain wet for prolonged periods of time.
Once all outside surfaces of the HLS are dry, remove the Power Module and ensure no liquids or moisture
droplets have entered the battery compartment. If the inside ever becomes wet, wipe away any excess liquid
from this area and thoroughly dry with compressed gas. You must remove any trapped moisture remaining in
the battery compartment before use. Do not expose the battery or electronics to fluids.
WARNING: Ensure there is no moisture or liquid trapped in the battery compartment or Heatsink
body prior to use.
IV - Preventative Maintenance
Over time the O-ring on your HLS Power Module may become dry. Lubricate the O-ring with silicone grease
as needed or every 3 months or 500 cleaning cycles. This is usually when the battery should be replaced
also. Remove and replace worn out or cracked o-rings immediately to maintain a proper seal.

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Figure 6. Lubricating/Replacing the O-ring
5. Troubleshooting
PROBLEM
POSSIBLE
CAUSE
ACTION
Loss of Illumination
Battery power is low.
Replace battery with a freshly charged battery.
Battery cannot supply sufficient current
at this power setting.
Change battery for a freshly charged battery.
Reduce the light intensity and continue using the
current battery. Recharge the battery as soon as
possible.
Light Guide does not attach properly
to the endoscope
The endoscope has an adapter on its
light post
Refer to the guide below and remove the adapter
The endoscope and light source do not
have a compatible coupling system
Contact Zibra Corp at 1-800-758-8773
Light intensity is low
Foreign material or film on HLS
window or attached endoscope.
Clean window with a cotton swab wet with isopropyl
alcohol until the debris or film is cleared off. Dry with
compressed air or gas.
Light source becomes hot after
prolonged use at full power.
Light source has been left on for more
than 30 minutes at full power.
Turn the light source to a lower intensity setting if the
examination must continue past 30 minutes. Or, turn the
light source off for a few minutes to permit adequate
cool down of the light source body.
Note: The standard light guide post consists of a snap-
ring groove for an ACMI fitting connection, a Wolf
adapter thread, and a Storz adapter thread. The HLS
attaches to the Storz adapter thread if marked
“UNIVERSAL” or the ACMI if marked “ACMI ”. If an
adapter sleeve (see Figure 8 below) is installed on the
light guide post, it must be removed prior to connecting
the HLS. Unscrew the adapter sleeve to remove it if it
is present. If the HLS is equipped with the Wolf Scope
Adapter, it will fit the wolf style light post.
Figure 7. Standard Universal Light Guide Post
Figure 8. Standard Light Guide Post (left), with Wolf Adapter (center), with Storz Adapter (right)
O-RING (INSIDE)

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6. Agency Compliance Statements and Guidance Tables
Medical Electrical Equipment needs special precautions regarding Electromagnetic Compatibility (EMC) and
needs to be installed and put into service according to the EMC information provided in this section.
Portable and Mobile RF communications Equipment can affect Medical Electrical Equipment.
WARNING: The equipment 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 prior to actual use.
Guidance and Manufacturer’s Declaration – Emissions
Guidance and Manufacturer’s Declaration – Immunity
Recommended Separation Distances between portable and mobile RF Communications Equipment
and the HLS: Equipment and Systems that are NOT Life-supporting
The HLS is intended for use in the electromagnetic environment in which radiated disturbances are
controlled. The customer or user of the HLS can help prevent electromagnetic interference by maintaining
a minimum distance between portable and mobile RF Communications Equipment and the HLS, according
to the maximum output power of the communications equipment.
Note: The HLS is internally battery powered and has no I/Os. Conducted RF Immunity testing does not
apply, resulting in no separation data from 150kHz to 80MHz.
7. Repair Service
Customer Service
The HLS is serviced by Zibra Corp. Use the following procedure for evaluation, repair or replacement.
1. Call Zibra at 1.800-758-8773 to request our RMA Form
2. Provide a detailed description of the problem and include the serial number.
3. If the light source needs to be returned, a Returned Material Authorization # will be issued.
4. The light source should then be sent to the address below for repair or replacement.
5. Include a copy of the RMA inside the package.
6. Have RMA number visible on the outside of the package.
Returning Goods to Zibra
Ship the HLS in a corrugated box to prevent damage during shipment. DO NOT INCLUDE BATTERIES.
Ship to: Zibra Corp
640 American Legion Hwy
Westport, MA 02790 USA
USA Tel: [phone]
Attention: Customer Service / RMA#______________
ATTENTION: If the light source has been used in a clinical setting, the light source must be
reprocessed according to procedures outlined in the Care & Maintenance section of this manual
before shipment.

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Upon evaluation, the customer will be contacted and advised of the findings and estimated repair cost.
Repairs will not begin until authorization or a purchase order is issued indicating the approval of charges.
8. Warranty
The Handheld Light Source (HLS) is warranted to be free from defects in materials and workmanship for a
period of one (1) year from the date of purchase.
All non-warranty repairs will be warranted to be free from defects in materials and workmanship for a period of
ninety (90) days from the date of the invoice.
Accidental damage and damage resulting from misuse, abuse, excessive sterilization, disinfection and
sterilization methods not approved by Zibra, as well as fluid invasion and normal wear and tear, will be
subject to prevailing repair charges. Disassembly, alteration, or repair performed by any person not
authorized by Zibra will result in immediate loss of warranty.
THE ABOVE WARRANTIES ARE IN LIEU OF ALL OTHER WARRANTIES EITHER EXPRESS OR
IMPLIED, INCLUDING ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR
PURPOSE.
Suitability for use of the medical device for any surgical procedure shall be determined by the user.
Zibra Corp shall not be liable for incidental or consequential damages of any kind.
All shipping charges to and from Zibra's facility is the responsibility of the customer.
9. Symbol Descriptions:
Attention: Read Operating Manual for Warnings, Cautions, and Instructions for Use
S/N This symbol indicates the product’s Serial Number.
In the European Union, this symbol indicates that when the end-user wishes to discard this
product, it must be sent to separate collection facilities for recovery and recycling. By
separating this product from other household-type waste, the volume of waste sent to
incinerators or landfills will be reduced and natural resources will thus be conserved.

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Purchase Date: _________________________
Part No: _______________________________
Serial No: ______________________________
NOTES:
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Part No. LS006-0057
Aug, 2018