Surgical inStrumentS
InstructIons for use
Caution
Nonste rile
Package Contents
Reference Number
Lot Number
Caution: U. S. federal law restricts this device for sale by or on the order of a physician.
Manufacturer
Consult Instructions for Use.
Channe l™ is a trad emark of C larus Med ical Syst ems, Inc.
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5.6 mm
2 mm
5.8 mm
19.7 cm 28.5 cm
2 mm
1
5 mm
3 mm
11 mm
7.5 mm
Biopsy F orceps
Diameter
REF No Diameter Working Length Compatible Channel Endoscopes
3221-002 2 mm 19.7 cm 2233-005, 2232-003, 2232-004
3221-001 3 mm 19.7 cm 2232-003
3220-002 2 mm 28.5 cm 2233-002, 2232-001, 2232-002
3220-001 3 mm 28.5 cm 2232-001
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Sciss ors
Diameter
REF No Diameter Working Length Compatible Channel Endoscopes
3221-002 2 mm 19.7 cm 2233-005, 2232-003, 2232-004
3320-002 2 mm 28.5 cm 2233-002, 2232-001, 2232-002
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Disse cting Prob e
/
REF No. Tip Angle Shaft Length Compatible Channel Endoscopes
3700-001 90º 28.5 cm 2233-002, 2232-001, 2232-002
3700-003 90º 19.7 cm 2233-005, 2232-003, 2232-004
3701-001 45º 28.5 cm 2233-002, 2232-001, 2232-002
3701-003 45º 19.7 cm 2233-005, 2232-003, 2232-004
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Surgical Instruments
Description
The Medtron ic Neurosurgery s tainless steel Surg ical Instrument s include Biopsy Forcep s, Grasping Forceps, Sci ssors,
and Dissec tion Probe.
Indications
The Surgical In struments are use d for tumor removal, third ven triculostomy, cys t fenestration, and ot her intracranial
procedur es.
Instruc tions for Use
The Surgical In struments are prov ided NONSTERILE and mus t be cleaned and sterilize d before each use.
The use of Medtr onic Neurosurger y Surgical Instrum ents is for surgeons in appr opriate endoscopi c procedures. It is the
responsib ility of the surgeon to be fa miliar with proper surg ical techniques.
Please ensure co mpatibility of ins trument length bet ween Surgical Inst ruments and Channel™ Neu roendoscope.
NOTE: As with any sur gical instrument , ensure that excessive for ce is not placed on instrumen ts. Excessive force app lied
to the device can res ult in damage to or failure of the dev ice.
Additional pr ecautions includ e those applicable to any sur gical procedure.
Indica tions
Medtroni c Neurosurgery Sur gical Instrument s are indicated for tumo r removal, third ventricu lostomy, cyst
fenestr ation, and other intrac ranial procedures .
Contrai ndications
None Known.
Warnings/Pr ecautions • MEDTRONIC NEUROSURGERY SURGICAL INSTRUMENTS ARE PROVIDED NONSTERILE AND MUST BE
Limitations • Be fore and after each use, inspect each surgical ins trument for signs of damage or wear. Check the
Point of Use
Containment /
Transportati on
Preparatio n for
Cleaning
Cleaning: Automa ted
(Do NOT use ultrasonic
washer)
Cleani ng, Sterili zation and Pr ocessing In structi ons
CLEANED AND STERILIZED PRIOR TO EACH USE.
• ONLY USE TOWELS THAT HAVE NO RESIDUAL DETERGENT AND THAT HAVE BEEN LAUNDERED IN NEUTRAL
DETERGENT.
• DO NOT USE WIRE BRUSHES OR STEEL WOOL.
• AVOID CONTACTING INSTRUMENTS WITH LINT, GLOVE TALC, OILY RESIDUE FROM SKIN, OIL-BASED SOAPS,
SYNTHETIC DETERGENT S, OR OTHER SURFACE CONTAMINANTS.
• MINERAL OIL OR SILICONE LUBRICANTS SHOULD NOT BE USED.
• DO NOT ALLOW CONTAMINATED DEVICES TO DRY PRIOR TO REPROCESSING. All subsequent cleanin g and
sterilizatio n steps are facilitated by not allowing blood, body fluid s, bone and tissue debris, saline or
disinfect ants to dry on used surfaces.
action of moving part s to ensure smooth operation throughout the intend ed range of motion.
• Repeated processing has minimal ef fect on these instrumen ts. End of life is normally determined by
wear and damage due to use.
• Use of hard water should be avoided, softened water is prefer able.
• Within 30 minutes f ollowing surgery, rins e the instruments un der warm (30-43 ºC) runni ng
tap water to remove all blo od, body fluids, and tissu e.
• It is recommended that instrumen ts be reprocessed within 2 hours followi ng use.
• Cover instru ments with damp towel s following rinse.
• Used instr uments must be tran sported in clos ed or covered contain ers to prevent unnece ssary
contamina tion risk.
• No special recommendation s.
• Prepare neutral pH enzymat ic detergent per the manufacturer ’s instructions using warm (30-43 ºC) tap
water (for example, EnzyCA RE®: ¼ oz/gallon (1.95 mL/L)). Soak device in the detergent for 5 minutes.
Flush hard to reach areas with a syringe.
• Place parts into an automatic washer (such as a Steris 444) for the process ing cycle.
PHASE
Pre-Wash 1 02:00
Enzyme Wash 02:00
Wash 1 02:00
Rinse 1 00:15
Instruct ions
RECIRCULATION TIME
(minutes)
TEMPERATURE
Cold Tap Water
(1-16 ºC )
Hot Tap Water
(40-75 ºC )
65.6 ºC
(Set point)
Hot tap water
(40-75 ºC )
DETERGENT TYPE
AND CONCENTRATION
(per the manufactu rer’s
instruct ions)
N/A
Enzymatic Deter gent
(for example, EnzyCAR E® 2:
¼ oz/gallon (1.95 mL/L))
Neutral pH Cleaner
(for example, NpH-Klenz ®:
¼ oz/gallon (1.95 mL/L))
N/A
Drying 15:00
• Ensure all instrument surf aces are clean and free of tissue, stains and other surface conta minants.
Cleaning: Manua l • Manual cleaning is preferred for all Surgic al Instruments.
• Rinse in warm (30-43 ºC) tap water for 2 minutes or until most visible debri s is removed.
• Soak for a minimum of 5 minutes in a mild, neutral pH enzymatic detergent (such as Enz yCARE® 2),
prepared at the use-di lution and temperature recommende d by the manufacturer. Gently scrub the
device with a stiff, plasti c brush.
• Rinse for a minimum of 2 minutes in warm (30-43 ºC) tap water.
Disinfec tion • No disinfectio n process validated.
Packaging • Commercially available, medical gra de steam sterilization pouches may be used to packag e individual
• Ensure all instrument surf aces are clean and free of tissue, stains and other surface conta minants.
• The validated cleaning procedur es are sufficient for decon tamination purposes .
instrument s (for example pouches with a paper density of 67-73 g/ m2.
• Ensure that the pouch is large enough to contain the instrume nts without stressing the pouch seals.
90 ºC
(unfiltered air)
N/A
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Sterilizatio n
Cleani ng, Sterili zation and Pr ocessing In structi ons
• Package devi ce in material suitabl e for steam autoclave pr ocessing.
• Follow the autocl ave manufacturer ’s instructions .
• Only Steam Sterili zation has been vali dated for these ins truments. Do not ove rload the autoclav e
chamber, as pocke ts may form, prevent ing full steam penet ration. If an autocla ve pan is used, place a
towel on the bot tom of the autoclave pan to abs orb excess water dur ing autoclaving.
Cycle Type Gr avity Pre-va c
Temperat ure
Time
Dryi ng 45 minutes (90° C, unfilte red air) N/A
• The followi ng steriliza tion methods ar e not recommend ed or validated:
-EtO
-Dry Heat
-Liquid Ster ilant
-Gas Plasma /S TERRAD Steriliz ation
-Low Temperatu re Steam & Formaldehyde
Maintenance and
Inspectio n
Storage • No special recommendations.
Additional
Informatio n
NOTE: The instructions provided above have been validated by the manufacturer as being CAPABLE of preparing the product for re-use. It
remains the responsibility of the processor to ensure that the reprocessing as actually performed, using equipment, materials and personnel
in the reprocessing facility, achieve the desired result. This normally requires validation and routine monitoring of the process.
• Before and after each use, inspec t each surgical instrument for signs of damage or wear.
• The device should not be used if any signs of damage or wear are noticed.
• Signs of damage include, but are not limited to surface pit ting, cracking, corrosion, roughn ess, rust or
distortion .
• Verify the action of moving part s to ensure smooth operation throughout the intende d range of motion.
• Store the Surgical Instrument s using any appropriate breathable wrapping mater ial selected by your
institution . Store in a clean and dry environment
• Where there is concern of TSE/CJD contaminat ion, Medtronic recommends that these dev ices be
incinerated rather than reu sed.
121 – 123°C
(250-254° F)
30 minute s minimum, no m aximum N/A
N/A
How Supplied
The Surgical Instruments are supplied NONSTERILE.
Do not use if package is damaged, as damage may have occurred to the instruments.
Patient Education
It is the responsibility of the physician to educate the patient and/or representative(s) regarding neuroendoscopic diagnostic
procedures. This should include a description of the complications associated with neuroendoscopy, and an explanation of
potential alternative products and treatments.
Warnings and Precautions
Avoid contacting instruments with lint, glove talc, oily residue from skin, oil-based soaps, synthetic detergents, or other surface
contaminants.
Care must be taken to ensure that particulate contaminants are not introduced into components during testing or handling.
Introduction of contaminants could result in improper performance of components.
Complications
While using irrigating f luid, one must constantly be aware of the signs of increased intracranial pressure. Classic systemic
signs of increased intracranial pressure include bradycardia, hypertension, respiratory abnormalities, and other standard
complications associated with neuroendoscopy. Minor complications of increased intracranial pressure include minor bleeding,
air entrapment causing nausea and vomiting, fever, late arousal from anaesthesia, and depressed breathing. Other potential
complications due to increased intracranial pressure include local and/or systemic infection, hemorrhaging, post-placement
seizures, and decreased cerebral perf usion pressure resulting in ischemic damage and brain herniation leading to irreversible
neurological damage, coma, and death.
Major complications from endoscopic procedures include uncontrollable bleeding, CSF fistula, infection, ventricular collapse
with subdural hematoma, and injury of brain structures.
Returned Goods Policy
Products must be returned in unopened packages, with manufacturer’s seals intact, to be accepted for replacement or credit,
unless returned due to a complaint of product defect or mislabeling. Determination of a product defect or mislabeling will be
made by Medtronic Neurosurgery, which determination will be final. Products will not be accepted for replacement or credit if
they have been in possession of the customer for more than 90 days.
Warranty
A. Standard Limited Warranty. Medtronic Neurosurgery warrants to the original end user purchaser (“Purchaser”) that the
enclosed product (“Product”) purchased by Purchaser, at the time of delivery to Purchaser, shall be substantially free from
defects in material and workmanship. Medtronic Neurosurgery makes no warranty (express, implied, or statutory) for
Products that are modified (except as expressly contemplated herein) or subjected to unusual physical stress, misuse, improper
operation, neglect, improper testing, use in combination with other products or components other than those for which the
Pro-ducts were designed, or use in any manner or medical procedure for which the Products are not indicated.
B. Remedy. Purchaser’s exclusive remedy and Medtronic Neurosurgery’s sole liability for breach of the foregoing warranty
shall be, at Medtronic Neurosurgery sole option and election, to replace the Product or credit Purchaser for the net amount
actually paid for any such Product; provided that (i) Medtronic Neurosurgery is notified in writing within ninety (90) days after
Purchaser’s receipt of the Product that such Product failed to conform, including a detailed explanation in English of any alleged
nonconformity; (ii) such Product is returned to Medtronic Neurosurgery within ninety (90) days after Purchaser’s receipt of
the Product F.O.B. 125 Cremona Drive, Goleta, California 93117, U.S.A. or as otherwise designated by Medtronic Neurosurgery;
and (iii) Medtronic Neurosurgery is reasonably satisfied that the claimed nonconformities actually exist. E xcept as expressly
provided in this paragraph, Purchaser shall not have the right to return Products to Medtronic Neurosurgery without Medtronic
Neurosurgery prior written consent.
C. Exclusion of Other Warranties. EXCEPT FOR THE LIMITED WARRANTY PROVIDED IN (A) ABOVE, MEDTRONIC NEUROSURGERY
GRANTS NO OTHER WARRANTIES OR CONDITIONS, EXPRESS OR IMPLIED, AND MANUFACTURER SPECIFICALLY DISCLAIMS
THE IMPLIED WARRANTIES AND CONDITIONS OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE. MEDTRONIC
NEUROSURGERY NEITHER ASSUMES NOR AUTHORIZES ANY OTHER PERSON TO ASSUME ANY OTHER LIABILITIES ARISING OUT OF
OR IN CONNECTION WITH THE SALE OR USE OF ANY PRODUCT.
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Australi an Sponsor:
Medtro nic Australasia P ty Ltd
97 Waterloo Rd
North R yde, NSW 2113 Aus tralia
Medtro nic, Inc.
710 Medtroni c Parkway NE
Minneapo lis, MN 55432-5604 USA
Design Facil ity
:
Medtro nic Neurosurg ery
125 Cremona Dr ive
Goleta, C alifornia 93117-5500 US A
(800) 468- 9710 USA/Ca nada
(901) 344-06 45 Int ernational
(800) 468- 9713 FAX USA/Cana da
(901) 396-2698 FAX Intern ational
13721-1E 26531
©Medtr onic, Inc. 2011
All Right s Reserve d
Printe d in USA
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