Care Fusion Snowden-Pencer Operation manual

DCN 45312
36-10271B
20APR2021
David Knuth
Vernon Hills, IL
Proofed by: _____________________________ Date:______________
Dimensions checked:________________ Copy checked: _____________
Snowden-Pencer, CareFusion, and the CareFusion
logo are trademarks or registered trademarks of
CareFusion Corporation, or one of its affiliates.
© 2013, 2021, CareFusion Corporation or
one of its affiliates. All rights reserved.
CareFusion
75 North Fairway Drive
Vernon Hills, IL 60061 USA
Australian and New Zealand Sponsors:
Becton Dickinson Pty. Ltd.
66 Waterloo Road
Macquarie Park, NSW 2113, Australia
Becton Dickinson Limited
14B George Bourke Drive
Mt. Wellington, Auckland, 1060 New Zealand
36-10271B • 2021-04
Distributed by
Snowden-Pencer™Headlamp
System Operation and Service
Manual
Rx Only
USA

DCN 45312
36-10271B
20APR2021
David Knuth
Vernon Hills, IL
Proofed by: _____________________________ Date:______________
Dimensions checked:________________ Copy checked: _____________
Catalog Numbers
89-8461, 89-8462
Indications for Use
This fiber optic headlamp system is designed to deliver illumination from a high intensity light
source for surgical site illumination.
This Operator Manual will help you to install the device and optimally integrate it with other
components of your system. It will also instruct you how to make adjustments, how to
keep it clean, and sterilize it. It will give you maintenance and service guidelines as well as
recommendations for best performance results.
Warnings and Cautions
• The user of this product should be thoroughly familiar with the use and care of this product.
• The user should carefully study the manual before making any attempt to use this product
clinically. Follow the instruction in the operating manual of other manufacturer’s equipment when
used with this product.
• Before each procedure, carefully inspect the fiber optic cable to insure the proper maintenance
and sterilization (when recommended).
• Light sources using high intensity lamps will produce heat as well as light. The high output of
such systems can cause burns.
• Use care not to point the light directly at the eyes during operation, the brilliant light can cause
severe eye discomfort.
• Fire Hazard: Do not drape or cover the light source or the fiber optic cable while it is operating.
Do not place the fiber optic cable end on the drapes while it is operating.
• Caution: The metal end fittings of the fiber optic cable get hot during operation. Allow to cool
outside the light source for at least five minutes before touching.
Assembling the Headlight System
Before continuing, remove the protective caps.
• To attach the fiber optic cable, insert the instrument end into the headlamp module until it snaps
in place. A bifurcated cable fits into the cable clips on both sides and rear of the headband.
• To remove the cable from the headlight module, grasp the body of the module in one hand and
the silicone junction of the cable in the other and pull up. Do not pull the cable by its legs.
• Remember, the fiber optic cable is made of glass fibers. When adjusting the cable on the
headband, do not bend the cable at an angle of more than 60 degrees.
• Next, place the headband on your head with the Rear Cranial Support sitting comfortably on
the back of your head; you can make size adjustments by turning the knob on the rear of the
headband until it feels comfortable. Then adjust the top knob on the Sagittal strap for more
comfort.
• Once the headlamp module and cable are connected, the unit is ready for use. The headlight is
provided with two prepackaged, sterile, and disposable joysticks. The joystick is to be threaded
onto the headlight module as shown and used to align and position the module.
• The system comes with gown clips to relieve the weight of the cable from the headband. One
gown clip is attached below the shoulder; the other is used to connect the cable to the surgeon’s
gown. This eliminates the risk of tripping or dropping the illuminator end.
• Caution: The metal portion of the fiber optic cable at the light source gets hot during operation.
Allow cooling for a minimum of five minutes outside the illuminator before touching.
2
en

DCN 45312
36-10271B
20APR2021
David Knuth
Vernon Hills, IL
Proofed by: _____________________________ Date:______________
Dimensions checked:________________ Copy checked: _____________
3
No. Description
1Deluxe Dual Ratchet Headband
2Foam Comfort Liner Set
33.5 mm Bifurcated Lensed Cable
4Joystick, prepackaged sterile
5Headlight Module, adjustable spot
No. Description
1Sport Soft Headband
23.5 mm Bifurcated Lensed Cable
3Joystick, prepackaged sterile
4Headlight Module, adjustable spot
Hard Headband
Soft Headband
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4
5
1
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3
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DCN 45312
36-10271B
20APR2021
David Knuth
Vernon Hills, IL
Proofed by: _____________________________ Date:______________
Dimensions checked:________________ Copy checked: _____________
4
Maintenance
Storing the headlamp system in a safe place will prolong the life of the unit. Fiber optic cables are
an optical instrument.
The following guidelines will help in sustaining the headlamp systems useful life:
• Forming the cable in sharp angles and kinks should be avoided whenever possible. The internal
fibers are made of glass, which will break under these conditions.
• Keep the optical faces of the cable from touching hard surfaces, which may cause scratches on
the surface. Scratches on the surface will diminish the light output.
• When cuts or punctures are visible in the silicone tubing, the cable is no longer safe to use. It
should be taken out of service immediately.
Cleaning
• The headlamp module can be wiped down with alcohol. The lens should be cleaned only with lens
tissue, follow the directions on the package.
• Follow all applicable bloodborne pathogen procedures as required by OSHA and/or your hospital,
when cleaning, disinfecting and sterilizing.
• The sweatband may be cleaned using a standard wash cycle in warm water and detergent.
• The headband can be cleaned with an alcohol wipe down or washed with a lukewarm solution of
water and mild detergent. Rinse thoroughly.
• Sterilizing of lensed fiberoptic cables should be avoided. The lens at the end of the cable is not
sealed and moisture will enter between the lens and the cable.
• The Joystick is prepackaged, sterile, and disposable.
• Warning: Do not autoclave the Joystick, Headband, Lensed Cables or Sweatband.
Warranty
CareFusion offers a lifetime guarantee on every surgical device bearing the Snowden-Pencer brand
name (unless otherwise noted) to be free of functional defects in workmanship and materials when
used normally for its intended surgical purpose. Any Snowden-Pencer device proving to be defective
will be replaced or repaired at no charge.
Repair Service
Regardless of age, if any Snowden-Pencer device needs service, return it to an authorized repair
service center. For repairs outside the U.S., please contact your local distributor.
Note: All devices being returned for maintenance, repair, etc. must be cleaned and sterilized per
these instructions for use prior to shipment.
Contact Information
BD Customer Service
800-323-9088
For email inquiries:
[email protected]
For customers outside of the USA, please contact your local distributor.
www.bd.com
Other Resources: To learn more about sterilization practices and what is required of manufacturers
and end users, visit www.aami.org, www.aorn.org, or www.iso.org.