Bipolar pencil coagulator
InstructIons for use
Caution
Nonste rile
Do not dispose of in trash
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.
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1
(1) Bipolar G enerator
(2) Bipolar Pe ncil
(3) Standar d Bipolar
Elect rical Cord
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Bipolar Pencil Coagulator
Description
The Medtron ic Neurosurgery Bi polar Pencil Coagulator is a reus able, bipolar, electro hemostasis coagu lator, with an
insulated shaf t. The Bipolar Pencil Coag ulator is designed to pass th rough the built-in inner ca nnula of the Medtronic
ChannelTM Neuroendo scopes. The Bipolar Penc il Coagulator is available in lon g and short lengths. Plea se ensure
compatibil ity between Bip olar Pencil length and the Chann el Neuroendoscop e being used.
Reference
No.
3900-0 02 2 mm 30 cm 2233-002
3901-002 2 mm 19.7 cm 2233-005
Indications
The Bipolar Penc il is designed to provide bip olar, electrohemos tasis coagulation.
Instruc tions for Use
CAUTION: A THOROUGH UNDERS TANDING OF BIPOLAR ELECTROCAUTERY, INCLUDING TECHNICAL PRINC IPLES,
CLINICAL APPLICATIONS, CONTR AINDICATIONS, AND RISKS IS NECESSARY BEFORE USING THIS PRODUCT.
THIS DEVICE IS NOT CAPABLE OF STOPPING ALL BLEEDING. BLEED ING MUST BE CONTROLLED, AS BLOOD CAN
OBSTRUCT VISIBILIT Y IN THE SURGICAL FIELD.
INSPECTION:
Carefu lly remove the Bipola r Pencil from packa ging. Do not bend or kink th e long shaft. Inspe ct the
Bipolar Pen cil for damage.
1. Before and af ter each use, verify t hat the distal tip of the Bipola r Pencil is bent at a slight angle (10 degrees) and
that the shaf t is straight.
2. Inspect th e insulation of the Bipolar Penc il for cracks, nick s, cuts, dents, or depr essions. Do not use if damage d.
Imperfe ctions may decreas e the effecti veness of the insulation an d may result in burns to the surgeo n or
patient.
3. To use the Bipolar Pencil, con nect the two pins on the pro ximal end of the pencil to a stand ard bipolar electr ical
cord. Connec t the proximal end of the bipo lar electrical cor d to the bipolar generator.
4. Frequently c lean the distal tip of the Bipo lar Pencil with saline- wetted gauze during us e. If the tip becomes
covered with to o much tissue, it will lose its ef fectivene ss.
WARNING: BE ABSOLUTELY SURE THE BIPOLAR GENERATOR IS SET TO THE LOWEST SETTING (Z ERO) BEFORE
TESTING THE BIPOLAR PENCIL . DO NOT EXCEED 35 WATTS IN ANY GENERATOR SETTING.
CAREFULLY TEST THE BIPOLAR PENCIL BY SLOWLY INCREASING THE SET TINGS BY SMALL INCREMENTS. DO NOT
EXCEED 500 VOLTS. A SETTING THAT IS TOO HIGH MAY SHORT THE BIPOLAR PENCIL , RENDERING IT USELESS.
DO NOT TOUCH THE ELECTRODE WHEN DEV ICE IS ACTIVATED. INJURY COULD RESULT.
ENSURE THE ACTIVE ELECTROD ES ARE IN THE FIELD OF VIEW DURING ENERGY APPLICATION.
DO NOT ACTIVATE WHILE DEVICE IS BEING INSERTED INTO OR BEING WITHDR AWN FROM ENDOSCOPE CANNULA.
DO NOT USE THE BIPOLAR PENCIL NEAR FLAMM ABLE ANAESTHETIC OR OXIDIZING GASES.
How Supplied
The Bipolar Penc il Coagulator is supplied NON STERILE.
Do not use if package is damag ed, as damage may have occurred to th e device.
Patient Educ ation
It is the responsi bility of the physician to e ducate the patient and/or rep resentative(s) regard ing neuroendoscop ic
diagnosti c procedures. This sho uld include a descript ion of the complication s associated with neur oendoscopy, and
an explanati on of potential alternati ve products and trea tments. Referen ce the Instructio ns for Use for the Channel
Neuroendo scope for a descript ion of Neuroendosco pic procedures.
Warnings and Precautions
Do not touch the elec trode when device is ac tivated. Injur y could result.
Do not activa te while device is being inser ted into or being withdr awn from endoscope c annula.
Do not use the Bipol ar Pencil near flammable ana esthetic or oxidiz ing gases.
Avoid contac ting instrument s with lint, glove talc, oily res idue from skin, oil-ba sed soaps, synthe tic detergents, or
other surf ace contaminants.
Care must be take n to ensure that particul ate contaminants are not in troduced into compone nts during testing or
handling. Intr oduction of contam inants could result in imp roper perform ance of components.
Complications
While using irr igating fluid, one mus t be constantly aware of the si gns of increased intra cranial pressure. Clas sic
systemic sig ns of increased intrac ranial pressure inc lude, but are not limited to, bradyc ardia, hypertens ion, and
respirato ry abnormalitie s. Potential complicat ions of increased intr acranial pressure in clude, but are not limited
to, decrease d cerebral perfusi on pressure resulti ng in ischemic damage and brai n herniation leading to ir reversible
neurologi c damage, coma, and death.
One major compli cation associate d with neurosurger y is the risk of infectio n, particularly men ingitis and ventricu litis.
Infect ions are usually due to organism s that inhabit the skin, par ticularly Staphyl ococcus epider midis. However,
other pathog ens circulating in the blo odstream may cause inf ection.
A second major com plication associa ted with ventricular dr ainage of CSF is overdrainag e, which can lead to intracra nial
hemorrha ge and permanent neurolo gical deficit . Overdrainage can occ ur due to improper fluid in fusion and egress
during the endo scopic procedure, re sulting in either elevat ed ICP or excessive overdrain age.
Overdrain age of CSF may result in excessive re duction of CSF pres sure and predispose th e development of a subdural
hematoma or hydro ma. In infants, excessiv e reduction of press ure will cause marked depr ession of the anterior
fontanell e, overriding of cranial bon es, and may convert communic ating into obstruc tive hydrocephalus . Care must be
taken to manage f luid exchange.
Frequent punc tures of the brain can pr edispose patient to int racerebral hemor rhage and edema causing a fu rther rise
in ICP.
Complicati ons associated with ne urosurgery may be simi lar to those experience d in any surgical procedur e carried out
under local and /or general anesthesi a. These include reac tions to drugs and anesth etic agents, elect rolyte imbalance,
and excessive bl ood loss, particul arly in infants. In rare ins tances, the patient may ex hibit a reaction due to sen sitivity
to the implant.
The use of prophy lactic antibiotic s is somewhat controver sial because their us e may predispose infec tion by more
resistan t organisms. Therefo re, the decision to use antibi otics prophylac tically rests wi th the attending physic ian and/
or surgeon.
Diameter Working
Length
Compatible
Endoscope s
2232-001
2232-002
2232-003
2232-004
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Cleaning, Sterilizat ion and Processi ng Instructi ons
Warnings /
Precaut ions
Limitati ons • Inspect fo r damage, see section on Ins pection.
Point of Use • Within 30 minutes fo llowing surgery, rinse th e Bipolar Pencil under warm (30 -43 ºC) running
Containm ent and
Transport ation
Prepara tion for
Cleanin g
Cleanin g:
Automated
(Do NOT use
ultraso nic washer)
Cleanin g: Manual •Manual cleani ng is preferred for the Bi polar Pencil.
Disinfe ction • No disinfect ion process validate d.
Packagin g • Commercially available, me dical grade steam ster ilization pouche s may be used to package
Steriliz ation • Steam autoclave ster ilization is the recom mended method of ster ilization for the Bipo lar
• DEVICE IS PROVIDED NON -STERILE AND MUST BE CLEANED AND STERILIZED BEF ORE EACH USE.
• DO NOT USE WIRE BRUSHES OR STEEL WOOL .
• ONLY USE TOWELS THAT HAVE NO RESIDUAL DETERGENT AND THAT HAVE BEEN LAUNDERED IN
NEUTRAL DETER GENT.
• DO NOT ALLOW CONTAMINATED DEVICES TO DRY PRIOR TO REPRO CESSING. All subsequen t
cleaning and st erilization steps ar e facilitated by not allowi ng blood, body fluid s, bone and
tissue debri s, saline or disinfec tants to dry on used sur faces.
• Use of hard water should b e avoided, softened wa ter is preferable.
Instruc tions
tap water to remove all blo od, body fluids, and tissu e.
• It is recommende d that devices be reproce ssed within 2 hours fol lowing use.
• Cover devices wit h damp towels following rinse.
• Used devices mus t be transported in cl osed or covered containe rs to prevent unnecess ary
contaminat ion risk.
• No special recom mendations.
• Not recommend ed.
• Not validated.
• Rinse in warm (30- 43 ºC) tap water for 2 minutes or unti l most visible debris is rem oved.
• Soak for a minimum of 5 minu tes in a mild, neutral pH enzy matic detergent (such
as EnzyCA RE® 2), prepared at the use-dil ution and temperatur e recommended by the
manufac turer. Gently clean with a sti ff plastic brush. Ge ntly brush the distal tip of t he pencil.
• Rinse for a minimum of 2 min utes in warm (30-43 ºC) tap wat er.
• Ensure all the sur faces are clean and free of ti ssue, stains and other sur face contaminant s.
• The validated cle aning procedures are su fficient fo r decontamin ation pur poses.
individua l instruments (for example pouch es with a paper density of 67-73 g/ m2.
•Ensure that th e pouch is large enough to contai n the instruments wi thout stressing th e pouch
seals.
Pencil. Follow the aut oclave manufactu rer’s instructi ons.
• Steam Sterilizat ion: Do not overload the autocl ave chamber, as pockets may form, pr eventing
full steam pen etration. If an autoclave pa n is used, place a towel on the bottom of th e
autoclave pan to abs orb excess water during au toclaving.
Cycle Type Gravit y Pre-va c
Temperat ure 121 – 123°C
Time 30 minute s minimum, no max imum N/A
Dryi ng 45 minutes (90° C, unfilte red air) N/A
• The followi ng sterilizati on methods are not rec ommended or valid ated:
-EtO
-Dry Heat
-Liquid Steri lant
-Gas Plasma /ST ERRAD Sterilizatio n
-Low Temperature Stea m & Formaldehyde
Maintena nce and
Inspec tion
Storage • No special recom mendations.
Addition al
Informa tion
NOTE: The instr uctions provide d above have been validated by the manu facturer as being C APABLE of preparing the
product f or re-use. It remains the re sponsibility of the pr ocessor to ensure that th e reprocessing as act ually performe d,
using equipm ent, materials and pers onnel in the reprocessi ng facility, achieve the des ired result. This norm ally requires
validation an d routine monitoring of t he process.
• Before and af ter each use, inspect th e Bipolar Pencil for any damage as de scribed in the
Inspect ion section. Do not use if da maged.
• Store the Bipolar Penc il using any appropriate, br eathable wrapping mate rial selected by
your instit ution. Store in a clean and dry envi ronment.
• Where there is conce rn of TSE/CJD contamin ation Medtronic rec ommends that the produc t
be incinerat ed rather than reused.
(250-254° F)
N/A
Returned Goods Policy
Product s must be returned in uno pened packages, wi th manufacturer ’s seals intact, to be accepte d for replacement
or credit, unl ess returned due to a compla int of product defec t or mislabeling. Dete rmination of a produc t defect or
mislabeling wi ll be made by Medtronic Neuro surgery, which deter mination will be final. Pr oducts will not be accep ted
for replaceme nt or credit if they have been in pos session of the custom er for more than 90 days.
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Warranty
A. Standar d Limited Warranty. Med tronic Neurosurge ry warrants to the ori ginal end user purchase r (“Purchaser”)
that the enclos ed product (“Produ ct”) purcha sed by Purchaser, at the time of deliver y to Purchaser, shall be
substant ially free from defe cts in material and work manship. Medtroni c Neurosurgery make s no warranty (express,
implied, or st atutory) for Produc ts that are modif ied (except as expressly cont emplated herein) or subjec ted to unusual
physical st ress, misuse, imprope r operation, neglec t, improper testin g, use in combination with ot her products or
component s other than those for whic h the Products were des igned, or use in any manner or medic al procedure for
which the Prod ucts are not indicate d.
B. Remedy. Purchas er’s exclusive remedy and Me dtronic Neurosur gery’s sole liabilit y for breach of the forego ing
warrant y shall be, at Medtronic Neuro surgery’s sole optio n and election, to replace t he Product or credit Pu rchaser
for the net amoun t actually paid for any such Pro duct, provided th at: (i) Medtronic Neurosu rgery is notifi ed in writing
within ninet y (90) days after Purchase r’s receipt of the Produc t that such Product fail ed to conform, includin g a detailed
explanati on in English of any alleged noncon formity; (ii) such Pro duct is returned to Med tronic Neurosurge ry within
ninety (90) days af ter Purchaser’s recei pt of the Product F.O.B. 125 Cremona Drive, Golet a, California 93117, U.S.A. or
as otherwi se designated by Medtr onic Neurosurger y; and (iii) Medtronic Neuro surgery is reasona bly satisfied th at the
claimed nonco nformities ac tually exist. Except a s expressly provide d in this paragraph, Purch aser shall not have the
right to retur n Products to Medtr onic Neurosurger y without Medtron ic Neurosurgery ’s prior written conse nt.
C. Exclusi on of Other Warranti es. EXCEPT FOR THE LIMITED WARRANTY PROVIDED IN (A) ABOVE, MEDT RONIC
NEUROSURGERY GRANTS NO OTH ER WARRANTIES OR CONDITIONS, EXPRESS OR IMPLIED, AND MANUFACTURER
SPECIFICALLY DISCLAIMS THE IMPLIED WARRANTIE S AND CONDITIONS OF MERCHANTABILITY AND FITNESS
FOR A PARTICULAR PURPOSE. MEDTRONI C NEUROSURGERY NEITHER ASSUMES NOR AUTHORIZES ANY OTHER
PERSON TO ASSUME ANY OTHER LIABILITIE S 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 Australia
Medtro nic, Inc.
710 Medtroni c Parkway NE
Minneapo lis, MN 55432-560 4 USA
Design Facil ity
:
Medtro nic Neurosurg ery
125 Cremona Dr ive
Goleta, C alifornia 93117-5500 USA
(800) 468- 9710 USA/Canada
(901) 344-06 45 Inte rnational
(800) 468- 9713 FAX USA/Canada
(901) 396-2698 FAX Internatio nal
13971-1D 26530
©Medtr onic, Inc. 2011
All Right s Reserve d
Printe d in USA
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