Medtronic 8004105 Instructions for Use

Battery-Power Driver

DESCRIPTION

Medtronic Neurosurgery’s Battery-power driver assembly consists of a resposable handheld instrument and
a separa tely purchas ed replaceabl e single-us e battery (F ig 1). The device is made f rom a variet y of materials
commonl y used in ort hopedic and ne urosurgica l procedure s, including s tainless s teel and resin b onded compos ite
materials. These materials meet available national standard specifications as applied to these devices.

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INDICATIONS

The Battery-power driver is designed for use during surgical implantation of Medtronic Neurosgurgery’s cranial
and craniofacial devices.

NOTE: It is re commended th at only Medtr onic instru ments be used t o implant Medt ronic device s.

INSTRUCTIONS FOR USE

The Bat tery-powe r driver is a resp osable devi ce that can be ste rilized and re used over a shor t duration.
Degrad ation of the tor que output wi ll occur with r epeated auto clave exposur es. Dispose o f device if the
driver b egins to exhib it a reduced ca pacity to dr ive in the Ti-M esh screws, an d contact yo ur local Medt ronic
representative for a replacement.

Instruments must always be examined prior to use in surgery. Examination should be thorough, and in
parti cular, should tak e into account a vi sual and func tional inspe ction of the w orking sur faces, sprin g or torsional
operat ion, switch an d motor operat ion, the pres ence of any crack s, bending o r distorti on, and that all com ponents
of the instrument are intact and complete.

Never use i nstrument s with obvio us signs of exces sive wear, damage, or t hat are incomp lete or other wise non­functional.

The Bat tery-powe r driver is supp lied NON-STERILE and must be clea ned and steri lized prior to u se. Follow the
Cleaning and Sterilization instructions below prior to introduction into a sterile field.

Additio nally, all instr uments that h ave been previo usly taken into a s terile surg ical field m ust firs t be
decont aminated and cl eaned using es tablished h ospital pro cedures bef ore sterili zation and rei ntroduct ion into a
sterile surgical field.

CAUTION: NE VER EXPOSE THE BATT ERY-POWER DRIVER TO TEM PERATURES IN EXCESS O F 132˚C (270˚F).
CAUTION: REMOVE THE BATTERY FR OM THE BATTERYPOWER DRI VER PRIOR TO CLEANIN G OR

STERILIZATION.

Remove all packaging material prior to cleaning and sterilization.

Cleaning

The Bat tery-powe r driver is prov ided NON-STERILE and must be cle aned and steri lized befor e each use. Manua l
cleaning is preferred for the instrument. Remove all packaging material prior to sterilization.

Immediately following surgery, rinse the Battery-power driver under warm running water (<50°C) to remove
all bloo d, body fluid s, and tissue. To cle an, use enzym atic deterge nt of neutral pH d iluted accor ding to the
manufacturer’s instructions. Under warm (<50°C) running water, gently scrub the instrument with a stiff plastic
brush. Do not us e wire brush es or steel woo l. Rinse devi ce in warm (<50°C) wat er for at least t wo minutes.
Make sure al l instrumen t surfaces a re clean and fr ee of tissue and s tains. Pack age instrum ent in material s uitable
for stea m autoclave pro cessing, or in t he original s torage tray.

Note: Cleaning solutions such as those containing formalin, glutaraldehyde, bleach and/or other
alkaline cleaners may damage the Battery-power driver; these solutions should not be used.

Sterilization

After cleaning, steam sterilize the Battery-Power Driver according to the following process parameters:

METHOD CYCLE TEMPERATURE EXPOSURE TIME

Steam Pre-Vacuum 132˚C (270˚F) 10 min.

If hospi tal steriliz ation proto col diffe rs from the re commended p arameters, i t is recommend ed that hospi tals
estab lish their own s team steriliz ation cycl es by validatin g their steri lization equ ipment and c ycle through t he
use of appropriate standards.

CAUTION: ALWAYS CLE AN AND RE-STERILIZE THE BATTE RY-POWER DRIVER AFTER S URGICAL USE. ENSUR E
THAT THE BATTERY COMP ONENT HAS BEEN REMOV ED PRIOR TO CLEANING AN D RE-STERILIZATION.

Battery Install ation

The Battery component is supplied STERILE and is acce ptable for us e if the packag ing integrit y has not been
comprom ised. Batt eries are single-use only and mu st be discard ed per estab lished hospi tal procedu res.

CAUTION: D O NOT CLEAN OR AUTOCLAV E BATTERIES. BATTERIES M AY BE DAMAGED BY EXPOS URE TO
ELEVATED TEMPER ATURES CAUSING ELECTR OLYTE SOLVENT TO LEAK FROM BAT TERY CASING.

The bat tery is inst alled into the s terile Bat tery-power d river so that t he yellow warnin g label is expo sed and the
contac ts are inside t he cavity (Fi g 2). Gently push the b attery in to the hollow bas e of the Batte ry-power dr iver
until it sn aps into place.

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NOTE: Test tha t the tool tip is s ecure by gen tly pullin g on it. If the too l tip comes ou t, repeat the
installation instructions above until a secure connection has been made.

NOTE: After tool has been securely installed, test the forward (▲) and reve rse (▼) butt ons on the
Battery-power driver to be sure they are operational. If they are not, remove and reinstall the
batte ry per the in structio ns above. If the re is still no p ower, replace th e battery o r use the manu al
driver provided with the implants.

Implantation

Refer to t he Instruc tions for Use w hich accompan y the device to be im planted.

Implant Removal

The Bat tery-powe r driver may be us ed for implant r emoval purpo ses, using the r everse (▼) f eature and any o ne
of the various sizes of available driver blades.

It should b e noted that whe re excessive b one growth ha s occurred, t here might be ad ded stress p laced on the
instr uments and the i mplants. Bo th Batter y-power driv er and implant may b e prone to possi ble breakag e. In
these c ases, it is nece ssary to f irst remove t he excess bone a nd/or tissue fr om around the i mplants.

STORAGE

Store at ro om temperatu re; 15-30˚C (59-86˚F).

HOW SUPPLIED

The Bat tery-Power D river is reus able and is suppl ied non-sterile.
The bat tery is for single-use only and i s supplied sterile. Steri lity can onl y be assured if t he packaging i s intact.
Package s for both ste rile and non-sterile components should be intact upon receipt. All packages should be

caref ully checked a nd all compone nts should be c arefully ex amined for sig ns of damage pri or to use. Damage d
packag es or produc ts should not b e used and shoul d be returne d to Medtronic N eurosurger y.

PATIENT EDUCATION

It is the phy sician’s respo nsibility to e ducate the pa tients and/or t heir repres entative(s) reg arding the use o f
these products during surgical procedures. This should include a description of associated warnings, precautions,
complications, and an explanation of potential alternative products and treatments.

CONTRAINDICATIONS

Medtro nic Neurosur gery’s Bat tery-powe r driver is not de signed for ot her than surgic al use.

WARNINGS AND PRECAUTIONS:

The battery component is SINGLE-USE ONLY. DO NOT CLE AN OR AUTOCLAVE THE BATT ERY.
BATTERY CAN E XPLODE OR CAUSE BURNS I F DISASSEMBLED, RECHAR GED OR EXPOSED TO FIR E OR HIGH

TEMPERATURE.

The meth ods of use for th e Battery -power drive r are determin ed by the user’s e xperience an d training in su rgical
procedures.

The Battery-power driver and/or battery should not be implanted.
Cleaning agents such as those containing formalin, glutaraldehyde, bleach and/or other alkaline cleaners must

not be used when cleaning the Battery-power driver.
Do not use t he Batter y-power drive r for any actio n for which it wa s not intended .
All prod ucts should b e treated wit h care. Improp er use or handli ng of the Batt ery-power d river and/or bat tery

may lead to da mage and possi ble improper f unctioni ng of the device.
The Bat tery-powe r driver shoul d be treated as any p recision in strument an d should be care fully place d on trays,

cleane d and sterilize d after each u se, and store d in a dry enviro nment.
Use only Medtronic specified batteries in the Battery-power driver.
Dispose of battery or other system components in accordance with local regulations and hospital procedures.

DO NOT IMMER SE the Battery-power driver or the battery.
DO NOT ATTEMP T TO DISMANTLE BATTERY-P OWER DRIVER.

To avoid injur y, the Batter y-power dri ver should be ca refully exa mined prior t o use for reduce d functio nality or
damage. A damaged instrument should not be used. Additional backup Screwdrivers and batteries should be
availabl e in case of an une xpected n eed.

Breakag e, misuse, or mish andling of the B attery- power driver may c ause injur y to the patient o r operative
personnel.

Any break age of a Batter y-power dr iver instrum ent or the impla nt could be extremely hazardous. Bro ken
fragments of instruments remaining in the body of a patient could cause allergic or infectious consequences.

Improper maintenance, handling, or poor cleaning procedures can render the Screwdriver unsuitable for its
intende d purpose, or e ven render it dan gerous to the p atient or surgi cal staf f.

Proper p atient selec tion and ope rative care ar e critical to t he success of th e device and avoi dance of injur y
during su rgery. Read an d follow all othe r product in formation su pplied by the ma nufactur er of the implan ts or
instruments.

Special precautions are needed during pediatric use. Care should be taken when using instruments in pediatric
patient s, since thes e patients ca n be more susce ptible to the st resses invo lved in their us e.

Never ex pose the Bat tery-powe r driver to tempe ratures in ex cess of 132˚C (270˚F) that may con siderably mo dify
the physical characteristics of the Batter y-power driver.

RETURNED GOODS POLIC Y

Produc ts must be re turned in uno pened packa ges, with manu facture r’s seals intac t, to be accepte d for
replace ment or credi t, unless retu rned due to a com plaint of prod uct defec t or mislabeli ng. Determin ation of
a produc t defect o r mislabeling w ill be made by Med tronic Neuro surgery, whic h determina tion will be fi nal.
Produc ts will not be a ccepted for re placement or cr edit if they hav e been in posse ssion of the cu stomer for mo re
than 90 day s.

Cleaning and sterilization must be performed before returning product to Medtronic Neurosurgery.

WARRANTY

A. Standard Limited Warranty. Medtronic Neurosurgery warrants to the original end user purchaser

(“Purcha ser”) tha t the enclosed s ingle use or reu sable produ ct (“Produc t”) purc hased by Purc haser, at the
time of de livery to Purc haser, shall be sub stantially f ree from de fects in ma terial and work manship. Med tronic
Neurosu rgery make s no warranty (e xpress, impl ied or statu tory) for Pro ducts that ar e modifie d (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 Products
were desi gned, or use in an y manner or medic al procedur e for which the P roducts a re not indicat ed.

B. Re medy. Pur chaser’s exc lusive remed y and Medtroni c Neurosurge ry’s sole liab ility for br each of the for egoing
warran ty shall be, at Me dtronic Neur osurgery ’s sole option an d election, t o replace the Pr oduct or cre dit
Purchas er for the net am ount actual ly paid for any suc h Product; p rovided tha t (i) Medtronic N eurosurger y is
notif ied in writi ng within nine ty (90) days aft er Purchaser ’s receipt of the P roduct tha t such Produc t failed to
confor m, including a d etailed exp lanation in Eng lish of any alleg ed nonconfor mity; (ii) suc h Product is r eturned
to Medtr onic Neurosu rgery with in ninety (90) day s after Purc haser’s recei pt of the Produc t F.O.B. 125 Cremona
Drive, Go leta, Calif ornia 93117, U.S.A. or as ot herwise de signated by Med tronic Neur osurgery; a nd (iii) Medtr onic
Neurosu rgery is rea sonably sat isfied tha t the claimed no nconformi ties actual ly exist. Ex cept as expre ssly provide d
in this par agraph, Purc haser shall not h ave the right to re turn Produc ts to Medtr onic Neurosu rgery wit hout
Medtronic Neurosurgery’s prior written consent.

C. Excl usion of Oth er Warrantie s. EXCEPT FOR THE LIM ITED WARRANTY PROV IDED IN (A) ABOVE,
MEDTRONIC NEU ROSURGERY GRANT S NO OTHER WARRANTIES O R CONDITIONS, EXPRE SS OR IMPLIED
AND MANUFACTU RER SPECIFICALLY DISCL AIMS THE IMPLIED WARRANT IES AND CONDITIONS OF
MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE. MEDTRONIC NEUROSURGERY NEITHER
ASSUMES NO R AUTHORIZES ANY OTHE R PERSON TO ASSUME AN Y OTHER LIABILITIES ARIS ING OUT OF OR
IN CONNECTI ON WITH THE SALE OR USE OF ANY PR ODUCT.

After b attery has b een install ed, test the Fo rward (▲) and Reve rse (▼) but tons on the Bat tery-powe r driver to
be sure th ey are operati onal. If they are n ot, remove and re install the b attery per t he instruc tions above. I f there
is still n o power, replace the b attery. If th e driver is stil l not operatio nal, use the manu al driver prov ided with the
implants.

NOTE: It is re commende d to have a replac ement batt ery availa ble.

Tool Installation

Instal l the desired to ol tip by pullin g the collar towar ds the body of th e Battery -power drive r and insert ing the
tool shan k into the openi ng (Fig 3). Push shank into t he Batter y-power driv er as far as it will g o.

Rotate th e tool tip unti l the collar snaps b ack into place.

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© Medtronic, Inc. 2009

16084-1D 24351

[phone] FAX International
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[phone] International
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Medtronic Neurosurgery

Design Facility:

Minneapolis, MN 55432-5604 USA
710 Medtronic Parkway NE
Medtronic, Inc.

The Netherlands
6422 PJ Heerlen

Earl Bakkenstraat 10
Medtronic B.V.
Authorized EC-representative:

Instructions for Use

Battery-Power Driver

Caution: Consult accompanying documents.

Nonsterile

Package Contents

Reference Number

Lot Number

Caution: For U.S. audiences only.

C AUTION: U. S. Federal law restricts this device to sale by or on the order

of a physician.

Manufacturer

Instruc tions for Use