Medtronic 27855 Instructions for Use

External Drainage and Monitoring Catheters

Description

EDM Ventricu lar Catheters , Barium Impre gnated

Becker ® EDMS Ventricu lar Catheter, 20c m and EDM Ventric ular Catheter, 35c m with Trocar pro ducts are f abricated
from sil icone elastom er tubing imp regnated wit h barium sulf ate to provide r adiopacit y. Relatively f irm tubing
is incor porated in the c atheter des ign to provide r esistance to c atheter kin king and compr ession. The ti p of the
cathet er is bullet shap ed and is fill ed with radio paque, tanta lum-impreg nated silicon e elastomer. Bla ck length
marker s made of graphi te-impreg nated silicon e elastomer ar e positione d on the cathete r at points 5, 10 and 15cm
from th e proximal tip to e nable the surg eon to gauge the d epth of penet ration of the c atheter into th e lateral
ventric le.

A stainl ess steel st ylet, pack aged with eac h catheter, is des igned to facil itate intro duction of th e catheter in to the
lateral ve ntricle. The c atheter is pac kaged with t he stylet in serted in th e lumen.

Becker EDM S Ventricular Cath eter, 20cm, Barium Im pregnated

This devi ce consists o f a barium-im pregnated si licone elasto mer ventricu lar catheter, 20c m in length, wi th black
length m arkers (at 5, 10 and 15cm fr om proximal ti p), a luerlock conn ector and a st ainless ste el stylet to f acilitate
placeme nt of the cathe ter in the lateral v entricle. Th e luerlock con nector inc ludes a plug to fa cilitate it s closure
prior to co nnection t o other draina ge or monitori ng system com ponents.

EDM Ventricu lar Catheter, 35cm, Bariu m Impregnate d with Trocar

This devi ce consists o f a barium-im pregnated si licone elasto mer ventricu lar catheter 35c m in length wit h black
length m arkers (at 5, 10 and 15cm fr om proximal ti p), a luerlock conn ector, a red end pl ug, a silicone el astomer
fixat ion collar, a stai nless steel s tylet and a s tainless ste el trocar.

Indications

The EDM Ventr icular Cathe ters are desi gned for use as t he proximal co mponent for ce rebrospina l fluid (CSF)
drainag e and/or monito ring from the l ateral ventri cles of the bra in.

Instruc tions for Use

A variet y of surgical t echniques m ay be used in plac ing the cathe ters into the lat eral ventric le. The site of
placeme nt and techniq ues used are at th e discretio n of the surgeo n.

CAUTION: LOW T EAR STRENGTH IS A CHAR ACTERISTIC OF MOS T UNREINFORCED SILICO NE ELASTOMER
MATERIALS. C ARE MUST BE TAKEN WITH THE HANDL ING AND PLACEMENT OF THE S ILICONE ELASTOME R
CATHETER TUBI NG TO AVOID CUTS, NICKS OR T EARS.

Surgical Tec hnique – Ventricu lar Catheter

The foll owing surgic al technique f or placement of t he ventricu lar catheter ha s been provid ed by Dr. Donald P.
Becker a nd his staff.

Prior to su rgery, the bal ance of the drain age and/or monit oring syst em should be comp letely asse mbled in
operat ional condit ion. The preop erative pre paration of th e patient is car ried out wit h the standar ds of care
approp riate for an int racranial op eration. A br oad-spec trum antibi otic is adminis tered preop eratively an d
continu ed during the 24- hour posto perative per iod.

The head is c ompletely sha ved, cleaned an d prepared in a m anner approp riate for cran iotomy. Using loc al
anesth esia, a 2.5cm par asagitt al incision is ma de just anter ior to the right c oronal sutur e in line with the m edial
margin of t he iris. A self- retaining r etractor i s inserted a nd the skull is ex posed by retr acting the p eriosteum .

A twis t drill hole dir ected sligh tly mesially is m ade with a 9/64” bit . Under ideal con ditions, the t wist dril l should
penetr ate the dura wi thout injuri ng the underly ing brain. Th e dura may also be op ened with a #11 surgic al blade.

With the s tylet in pla ce, the tip of the ve ntricular ca theter can be d irected f rom the twis t drill hole in th e following
ways:

1) toward th e inner canthu s of the ipsilate ral eye;

2) in a plane ali gned 2cm anter ior to the exte rnal auditor y canal in the c oronal plane;

3) toward th e bridge of the n ose; or

4) toward th e inner canthu s of the contral ateral eye.
If the ipsi lateral ventr icle is not ente red, the physic ian may choose t o attempt ins ertion of th e ventricula r catheter
from th e opposite sid e of the patient ’s skull. Should t his also fail, t he surgeon may co nsider the alt ernative of
monitor ing with a suba rachnoid bo lt (e.g., Richmond B olt).
The relat ive markers f or the incision s ite and direc tion for cat heter inser tion are illus trated in Fig ures 1a-b.
If a subar achnoid bolt i s to be used, then p lacing the bol t
in a new tw ist drill hole —to decreas e the possibi lity of
cloggi ng of the subara chnoid bolt w ith brain tiss ue—is
recomm ended.
When the ve ntricle is ent ered, the st ylet is withd rawn
and the ca theter is occl uded at the sca lp level by pinchi ng
with an ap propriate cl amp. Only a minim al amount of
CSF shoul d be permit ted to escape. T his is parti cularly
impor tant if the ICP is n ot elevated.

CAUTION: OV ERDRAINING MAY PREDI SPOSE TO VENTRICUL AR COLLAPSE, AND PO TENTIALLY SUBSTANTIAL
PATIENT INJURY.

The dist al end of the occ luded cathe ter is now tunnel ed under the sc alp to emerge th rough a stab wou nd placed
poster ior to the ventr iculostomy i ncision.

The EDM Ventr icular Cathe ter, 35cm, include s a trocar whi ch may be used to fa cilitate thi s placement. Th e trocar
may be inse rted into the d istal end of th e catheter fo r attachme nt. After des ired placemen t of the cathet er, cut
the dist al end of the cat heter to detac h the trocar.

The encl osed luerlo ck adapter may now b e inserted i nto the cathe ter and attac hed to other com ponents of th e
drainag e and/or monito ring system . Specific d etails regar ding cathet er connect ion are found in t he Instruc tions
for Use fo r the PS Medica l Becker EDMS an d PS Medical EDM K its.

Secure t he catheter t o the connect or with a doubl e suture tie usi ng
0 silk sutu re (Fig 2).

Care sho uld be taken to ens ure that the cat heter and the ba lance of
the drai nage and/or moni toring syst em is filled an d devoid of any
air bubb les. If the cat heter is prope rly
placed, a s atisfac tory wavefo rm
should be v isible on the mo nitoring
equipm ent. Minor adju stments of t he
ventric ular cathete r position may b e
necess ary to accomp lish this.

After a s atisfac tory wavefo rm is
obtain ed, the ventri culostomy wo und
is close d with interr upted sutur es and a
full hea d dressing app lied.

A silicone f ixation co llar may be
applie d prior to compl eting the full
head dre ssing. Spread o pen the collar
(Fig 3a) and po sition the ca theter inside
the groo ve within the co llar (Fig 3b).
Then, se cure the fix ation collar to t he
scalp by p assing a ligatu re through th e
two hole s in the flang e of the fixat ion
collar (Fi g 3c).

3a

3b

3c

Description

EDM Lumbar Ca theters,
Barium Im pregnated

EDM Lumbar C atheter, 24cm and E DM Lumbar Cath eter, 80cm prod ucts are fab ricated fr om silicone ela stomer
tubing i mpregnated w ith barium sul fate to provi de radiopaci ty. Relativel y firm tubin g is incorpor ated in the
cathet er to provide re sistance to k inking and comp ression. Th e open lumbar ti ps of the EDM Lumba r Catheter,
24cm and EDM Lu mbar Cathet er, Open Tip,
80cm, ar e trimmed at an an gle (Fig 4). The
lumbar ti p of the EDM Lumba r Catheter, Clos ed
Tip, 80c m is bullet-shap ed and fille d with
radiop aque tantalu m impregnate d silicone
elastom er (Fig 5). A PTFE-co ated stainl ess steel
guidew ire with adjus table stop is p rovided
with the C losed Tip 80 cm EDM Llumbar
Cathet er to facilita te placement. A ll catheter s
have multi ple inlet hole s located wi thin approxi mately 17 mm of the lumb ar tip. Length m arkers of grap hite
impreg nated silicon e elastomer ar e positioned o n the cathete rs at points 11, 16 and 21cm fro m the lumbar tip (an
additi onal 26cm leng th marker is incl uded on the 80c m EDM Lumbar Cat heters).

When the 11cm mar ker is aligned wi th the slot open ing in the hub of th e provided Tuohy n eedle, the tip o f the
cathet er is aligned wi th the tip of the ne edle.

The lumba r catheter de sign, guidewi re with adjus table stop (i f included), and t he 14-gauge Tuohy n eedle allow
for perc utaneous pl acement with out need for la minectomy.

Separa te silicone elas tomer fix ation tabs are i ncluded to anc hor the cathe ter as require d. All EDM Lumbar
Cathet ers include a lu er connecto r with cap and a si licone elasto mer strain r elief sleeve.

Indications

The EDM Lumb ar Catheter s are designe d for use as the pr oximal compo nent for CSF dr ainage and/or mon itoring
from th e lumbar subar achnoid space.

Instruc tions for Use

A variet y of surgical t echniques m ay be used in plac ing the cathe ters into the lu mbar subarac hnoid space. Th e site
of placem ent and techni que used are at th e discretio n of the surgeo n.

Surgical Tec hnique — EDM Lumba r Catheter

The use of l ocal or gener al anesthesi a during the pla cement of the ca theter is at the d iscretion o f the surgeon.
Cathet er patency pr ior to implant ation should b e verified by g ently flus hing sterile s aline solut ion through th e

cathet er. A 20-gauge bl unt needle ada pter is provid ed with the EDM Lu mbar Cathete rs, 80cm for t his purpose. I t
may be place d into the open en d of the cathet er to facilit ate flushing .

NOTE: Refe r to the “Guidew ire and Adjust able Stop” sec tion for
instr uctions on pr oper guidew ire use during c atheter imp lantation
(EDM Lumba r Catheter, 80c m Closed Tip on ly).

Positio n the patient on o ne side with pa rtial hip and k nee flexi on
(Fig 6). Prepa re and drape the s urgical area s (low back) as a st erile
field .

Make a 2cm inc ision betwe en the spinous p rocesses o f L4-L5 or
L5-S1. Elevate t he patient ’s head about 30° to in crease intr aspinal
CSF pres sure. Inser t the 14-gauge Tuoh y needle with t he bevel
cephalad , and advance int o the lumbar sub arachnoid sp ace.
Withdr aw the needle s tylet and low er the patient ’s head when a fre e flow of CSF is o btained. Int roduce the
lumbar c atheter thro ugh the Tuohy need le. Insert 8c m of catheter i nto the subarac hnoid space ce phalad to the
punct ure site. Slowl y remove the guid ewire, if used . Slowly remove t he Tuohy needle, le aving the cath eter in
place. Se cure the cath eter with fi xation tab(s).

Proper c atheter place ment in the lumb ar subarachn oid space shou ld be verifi ed. This is veri fied by the f low of CSF
from th e catheter or th rough the use o f appropriat e imaging tech niques. Occl ude cathete r with an approp riate
clamp or f inger press ure to ensure th at as little C SF as possible i s lost. Proper c atheter plac ement allows lu mbar
subarac hnoid drain age and pressu re monitorin g.

1. To Patient
Monitoring
System

7. Scalp

4

5

1a

2

2. Suture

4. Luerlock Connector

6

6

6. Suture Hole

2. Suture

1b

3. Fixation Collar

5. Catheter

8. Catheter
Exit Site

CAUTION: TO AVO ID POSSIBLE TRANSEC TION OF THE CATHETER , THE CATHETER SHOULD NE VER BE
WITHDRAWN TH ROUGH THE TUOHY NEED LE. IF THE CATHETER NEED S TO BE WITHDRAWN, THE TUOH Y
NEEDLE AND CATHE TER (WITH GUIDEWIR E, IF USED) MUST BE REMOVED SIMU LTANEOUSLY.

Silic one ela stomer f ixat ion tab s are pro vided t o anchor
the c athete r at the i ncisio n site, a s desire d. The t abs wra p
arou nd the c athete r and can be loca ted at an y point . The
fix ation t abs are a pplied to the c athete r by spre ading th em
open and posi tionin g the ca theter in the f ixatio n tab gr oove
(Fig 7a). The tab s are the n close d (Fig 7b). To secure the
fix ation t ab to the cathet er, a sutu re is pa ssed th rough t he
two h oles in the tab a nd tied . The ta bs are th en sutu red to
the e xpose d fasci a at the l umbar i ncision . The ca theter is lef t exter nalize d at this point.

Using the Lu mbar Catheter S train Relief

The Lumb ar Cat hete r Str ain Re lief is fa bric ated f rom
tra nsluc ent s ilico ne el astom er an d is d esig ned to fit
sec urel y over a lue rloc k conn ect or. Th e Stra in Re lief is use d
wit h PS M edic al Lum bar C athe ters to pr ovide supp ort to
and less en th e pote ntia l of c athet er ki nkin g at t he lue rloc k
con nect or ju ncti on.

Slide the sho rt tra nslucen t Strain Relief onto the exter nal
end o f the cat heter n arrow e nd fir st (Fig 8 a), so tha t the
fla red end o f the Str ain Rel ief is d irecte d towar ds the e nd of
the c athete r. The lue rlock c onnec tor may n ow be ins erted
into t he cath eter. Sli de the s hort t ransluc ent Stra in Reli ef
over t he luer lock co nnecto r (Fig 8 b) and ver ify th at the
cath eter/conn ector junct ion is in tact. Secure the str ain
reli ef and c atheter to the co nnect or with a tight s uture t ie
in th e groove of the s train r elief, u sing 0 si lk sutur e (Fig 8 c).
The p lug att ached t o the lue rlock connec tor may b e used t o
prev ent loss of CSF p rior to a ttach ment of the cat heter to the
pati ent line of the d rainage syste m.

7a

8a

10. Luerlock Cap

8b

8c

Guidewi re and Adjusta ble Stop

A PTFE -coate d stai nless s teel gu idewir e with ad justa ble
stop is prov ided wi th the PS Medic al EDM Lum bar Cat heter,
80cm , Close d Tip, to increa se the m aneuver abilit y of the
silic one cat heter.

To use the adju stable stop, l oosen the lue r cap. Partly
withdr aw the guidewi re from the dis penser. Pass the f lexible t ip of the guidew ire through t he luer fit ting of the
adjust able stop, out t he rounded en d, and into the con nector end of t he lumbar cat heter. Thread the g uidewire
throug h the connect or end of the cat heter so that th e guidewire co ntacts th e filled tip of t he lumbar cat heter.
Slide the a djustable s top so that the ro unded end is to uching the conn ector end of t he catheter. Ti ghten the cap to
aff ix the adjust able stop to the g uidewire. Di scard the gui dewire dispe nser.

7b

4. Luerlock
Connector

5. Catheter

2. Suture

Connect ion of Catheter to D rainage and/or M onitoring Syste m

Using the i ncluded luer lock connec tor, the PS Medic al EDM Lumbar Ca theter may be dir ectly att ached to a PS
Medica l Becker EDMS or P S Medical EDM Dr ainage Asse mbly.

NOTE: Ther e is slight resis tance to flo w caused by the lu mbar drainag e catheter. The av erage resist ance to flow at
a consta nt flow rate of 2 3 mL/hour is 0.1cm H
reduc tion of syste m pressure as c ompared wit h actual in vivo pr essure.

O per cm of c atheter leng th. This resis tance to flow m ay result in a

2

Needle less Inject ion Site

The Inter link® injec tion site is sin gle use only. Do not r esteriliz e.

1. Swab septu m of injectio n site with anti septic prio r to access.

2. Access In terlink injec tion site (id entified b y a colored rin g) with Interli nk cannula (not sup plied).

3. Replace ev ery 24 hours or p er institut ional protoc ol.

This pro duct does no t contain natu ral rubber lat ex.

CAUTION: IF NE EDLE MUST BE USED, INSERT SM ALL GAUGE NEEDLE INTO PERI METER OF SEPTUM.
CAUTION: D O NOT DISCONNECT ADM INISTRATION SET, SYRIN GE OR OTHER COMPONENT FR OM CANNULA

WHILE CANNUL A IS STILL CONNECTE D TO INTERLINK INJECT ION SITE.

How Supplied

EDM Ventricu lar and Lumba r Catheters; Need leless Inje ction Site

The EDM vent ricular and lu mbar cathete rs are suppli ed as individ ual product s, sterile an d non-pyrog enic in
double w rap package s. The Interlin k injectio n site is provid ed sterile. Th ese produc ts are design ed for single
patient u se only. Do not re -use, re-pr ocess, or re- sterilize th is product . Re-use, re- processin g or re-ster ilization
may compr omise the str uctural in tegrity of t he device and/or c reate a risk of con tamination o f the device, whi ch
could re sult in patient i njury, illnes s, or death. Med tronic Neuro surgery is n ot responsib le for the per formance of
any produ ct which has b een resteri lized.

Special Order Products

If this Ins tructio ns for Use accomp anies a speci al order prod uct, there wi ll possibly be d ifferen ces in the physi cal
charac teristic s between th e product en closed and th e product de scriptio n in this produc t package in sert. Thes e
diff erences will n ot affec t the safety o r effic acy of the spe cial order pro duct.

Specia l order produc ts may be supp lied sterile o r non-ster ile as indicate d on the produc t package la bel. Non­steril e product s must be cleane d and sterili zed prior to use .

Patient Educ ation

It is the phy sician’s respo nsibility to e ducate the pa tient and/or the ir represen tative(s) regar ding exter nal
drainag e and monitor ing. This shoul d include a desc ription of as sociated co mplication s, and an explana tion of
potenti al alternati ve product s and treatmen ts.

Contraindications

Intrac ranial press ure monitori ng with a ventr icular or lumba r catheter is co ntraindic ated in patien ts receivin g
anticoa gulants or who a re known to have a bl eeding diat hesis. The vent ricular cat heter is contr aindicated i f scalp
infec tion is prese nt. A patient un dergoing ex ternal drai nage and monit oring must be ke pt under conti nuous,
close su pervision . The use of a ventr icular or lumb ar drainage ca theter is cont raindicate d where train ed personn el
are not avai lable to super vise monit oring and drai nage on a 24-hour-a -day basis.

The use of a l umbar cathet er for drainag e and monitor ing of cerebro spinal flui d is not recomme nded for pati ents
with non -communic ating hydroce phalus; where l umbar punct ure is contra indicated; in t he presence o f large
intrac ranial mass le sions, tumor s, hematomas or c ysts; in th e presence of in fection s in the surroun ding area whic h
include s the skin, sub cutaneous t issue, bone and t he epidural sp ace; and in patie nts which have d emonstrate d
blocka ge of cerebros pinal fluid t o the subarac hnoid space due t o trauma, hemat oma, fract ure or tumor. The
use of a lumb ar catheter u nder these con ditions for e xternal dr ainage and mon itoring is at th e discretio n of the
physici an.

Monitor ing pressur e from the lumb ar subarachn oid space can b e done only in ins tances where l umbar punc ture
does not p ose a danger to th e patient.

Warnings and Precautions

It is the re sponsibilit y of the physic ian to descri be and explai n the followin g warnings, pr ecautions a nd
complic ations to the pa tient and/or his r epresenta tives prior t o proceedin g with any surgic al procedur es.

Failure to ap propriatel y adjust the ra te of CSF outf low through t he externa l drainage sys tem may result i n
potenti ally serious i njury to the pa tient.

Lint, f ingerprin ts, talc and oth er surface c ontaminant s or residues f rom latex glove s can cause fo reign body or
allergi c reactions .

Improp er use of instr uments in han dling or implan ting EDM Cathe ter product s may result in t he cutting, s litting,
breakag e or crushing o f component s. Such damage may l ead to a loss of sy stem integri ty, and necess itate surgic al
revisio n or removal of th e system.

Patient s undergoin g external d rainage and/or p ressure moni toring must b e constantl y supervis ed on a 24-hour­a-day ba sis for signs an d symptoms of ove rdrainage or u nderdrain age. Inadequat e vigilance or im proper drai nage
syste m setup can lead t o serious inju ry to the pati ent.

Patient s must be isola ted from ex ternal drain age systems , by adjustmen t of the stopco ck, prior to be ing moved
or repos itioned. Se e EDM Kits or Bec ker EDMS Instr uctions fo r Use booklet s for stopco ck adjustme nt instruc tions.
After an y movement or rep ositioning , it is imperati ve that the heig ht of the exter nal drainage s ystem is veri fied
for accu racy to the pat ient’s new pos ition. Failure t o ensure corre ct positio ning of the ex ternal drain age system
can lead to o verdrainage o r underdrai nage, and potent ially seriou s injury to the p atient.

Care mus t be taken to preve nt complete or p artial cat heter pullou t during patie nt movement or r epositioni ng.
Care mus t be taken to ensu re that parti culate conta minants are no t introduced i nto component s during

implant ation, testi ng or handling . This could res ult in imprope r perform ance of the sys tem.
In secur ing the ventri cular cathe ter to the luerlo ck connect or, the ligature en circling th e catheter sho uld be

secure ly, but not too tig htly, fastene d lest it eventu ally cut throu gh the silicone t ubing.
Care mus t be taken in the ro uting of cath eters to preve nt kinking an d needless ab rasion along t heir course.
A suture t ie with 0 silk sut ure should be us ed to secure t he strain reli ef to the luerl ock connec tor/catheter jun ction.

Check to e nsure that the co nnection i s secure pri or to use.
When the ce rebral ventr icles or lumb ar subdural sp ace are firs t puncture d during the in sertion of t he catheter,

care sho uld be taken to ens ure that as lit tle CSF as poss ible is lost.
Care mus t be taken durin g the placemen t of the cathete r into the lumba r subarachno id space to ensur e that the

cathet er is properl y located.
To avoid trans ection of t he lumbar cath eter during c atheter place ment, the cath eter should ne ver be withdr awn

throug h the Tuohy needle. I f the catheter n eeds to be with drawn, the nee dle, guidewi re and the cath eter must be
removed s imultaneou sly.

EDM Cathe ters should b e removed if the p atient develo ps signs of meni ngeal irrit ation or if ther e is suspicion o f
contami nation or infe ction in the o perative sit e or anywhere a long the subcu taneous dev ice.

Separa tion of EDM Cath eter componen ts due to disco nnection o r catheter fr acture has b een report ed.

Complications

The major c omplicatio n associate d with ICP monit oring with a ven tricular or lu mbar cathet er is the risk of
infec tion, part icularly men ingitis and ven triculiti s. The inciden ce of these inf ections ca n be reduced by c are in
inser ting the ventr icular cathe ter and stabi lizing it by pas sing it throug h a subgaleal tu nnel before i t emerges.
The lumba r catheter sho uld be stabil ized by use of f ixation tab s. Wound infec tions may occu r but usually sub side
when the c atheter is rem oved.

Limiti ng the duratio n of monitorin g from a single s ite to less than f ive days will re duce the infe ction rate. If
monitor ing must cont inue past f ive days, it is rec ommended tha t a new catheter b e inserted a t a fresh site, an d
the enti re system be ch anged.

Inadequ ate patient mo nitoring of in tracranial p ressure and C SF drainage may r esult in tempo rary or perm anent
brain dam age.

Frequen t puncture s of the brain to in sert the ven tricular cat heter can pre dispose to int racerebral h emorrhage a nd
edema ca using a furt her rise in ICP, and can re sult in perman ent damage to the c erebral tiss ue. This can res ult in a
loss of se nsory or mot or functio ns of the patien t.

Poor reco rding of ICP wil l result if the c atheter, patie nt line or other co mponents of t he monitorin g system
become c logged with b lood clots, b rain tissue f ragments o r fibrinou s debris.

In patien ts with small ve ntricles, t he ventricul ar walls may collap se around the t ip of the cathe ter resultin g in
obstr uction and p redisposin g to tentorial he rniation. It is t herefore e xtremely i mportant to a void excessiv e
release o f CSF before o r after the ca theter is att ached to the dr ainage syst em.

9. Strain
Relief

Returned Goods Policy

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.

Determ ination of a pro duct defe ct or mislabel ing will be made b y Medtronic Ne urosurger y, which determ ination will
be fina l.

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.

Warranty

A. Stand ard Limited Wa rranty. Med tronic Neuro surgery wa rrants to the o riginal end us er purchase r

(“Purcha ser”) tha t the enclosed s ingle use pro duct (“Prod uct”) pu rchased by Pur chaser, at the tim e of delivery t o
Purchas er, shall be subst antially fre e from defe cts in mater ial and workma nship. Medtr onic Neurosur gery makes
no warra nty (expres s, implied or st atutory) fo r Products t hat are modif ied (except as e xpressly con templated
herein) or su bjected to u nusual physic al stress, mi suse, imprope r operation, n eglect, im proper test ing, use in
combina tion with oth er product s or component s other than th ose for which t he Product s were designe d, or use in
any manner o r medical pro cedure for wh ich the Produ cts are not in dicated.

B. Remedy. Pu rchaser’s exc lusive remed y and Medtron ic Neurosurg ery’s sole lia bility for b reach 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 oth erwise des ignated by Med tronic Neuro surgery; an d (iii) Medtro nic
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 with out
Medtro nic Neurosur gery’s prio r written co nsent.

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
MERCHANTABILIT Y AND FITNESS FOR A PARTICU LAR PURPOSE. MEDT RONIC NEUROSURGERY NE ITHER
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.

Instructions for Use

External Drainage & Monitoring Catheters

Caution: Consult Accompanying Documents

Sterilization: Ethylene-Oxide Gas

Use by

Package Contents

Do Not Reuse

Reference Number

Lot Number

Caution: For U.S. audiences only.

Caution: U. S. federal law restricts this device to sale by or on the order of a physician.

Manufacturer

Becker® and PS Medical® are registered trademarks of Medtronic, Inc.

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

Design Facility:

Medtronic Neurosurgery
125 Cremona Drive
Goleta, California 93117-5500 USA
[phone] USA/Canada 17556COM-1A 24662
[phone] International © Medtronic, Inc. 2009
[phone] FAX USA/Canada All Rights Reserved
[phone] FAX International Printed in USA

EDM Ventricular Catheter, Barium Impregnated
Becker EDMS Ventricular Catheter, 20cm, Barium Impregnated

EDM Ventricular Catheter, 35cm, Barium Impregnated with Trocar