Medtronic 27659 Instructions for Use

Care mus t be taken to prev ent complete or p artial cat heter pullou t during pati ent movement or r epositioni ng.
Care mus t be taken to ensu re that parti culate conta minants are no t introduced i nto componen ts during

implant ation, test ing or handling . This could res ult in imprope r perform ance of the sys tem.
In securing the ventricular catheter to the Luerlock connector, the ligature encircling the catheter should be
secur ely, but not too tig htly, fastene d lest it eventu ally cut throu gh the silicon e tubing.
Care mus t be taken in the ro uting of cath eters to prev ent 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 rel ief to the Luerl ock connec tor/catheter

junct ion. Check to en sure that the co nnection is s ecure prio r to use.
When the ce rebral ventr icles or lumb ar subdural sp ace are firs t punctur ed 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 cathet er into the lumba r subarachno id space to ensu re that the

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

through the

Tuohy needl e. If the cathet er needs to be wi thdrawn, the n eedle, guide wire and the cat heter must be

removed simultaneously.
EDM Cathe ters should b e removed if the p atient develo ps signs of meni ngeal irrit ation or if the re is suspicio n of

contami nation or infe ction in the o perative si te or anywhere a long the subc utaneous dev ice.
Separation of EDM Catheter components due to disconnection or catheter fracture has been reported.

Complications

The major c omplicatio n associate d with ICP monit oring with a ven tricular or l umbar cathet er is the risk of
infec tion, part icularly men ingitis and ve ntriculiti s. The incide nce of these inf ections c an be reduced by c are in
inser ting the ventr icular cath eter and stabi lizing it by pas sing it throu gh a subgaleal tu nnel before i t emerges.
The lumb ar catheter sh ould be stabi lized by use of f ixation tab s. Wound infec tions may occ ur but usually su bside
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. I f
monitor ing must cont inue past f ive days, it is rec ommended tha t a new cathete r be inserte d at 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 per manent
brain damage.

Frequen t puncture s of the brain to in sert the ven tricular cat heter can pre dispose to int racerebra l hemorrhage a nd
edema ca using a furt her rise in ICP, and can re sult in perman ent damage to the c erebral tis sue. This can res ult in a
loss of se nsory or moto r 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 monitori ng system
become c logged with b lood clots, b rain tissue f ragments or f ibrinou 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 i s therefore e xtremely i mportant t o avoid excessi ve
release o f CSF before o r after the ca theter is att ached to the dr ainage syst em.

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 ret urned due to a com plaint of prod uct defec t or mislabeli ng.

Determ ination of a pro duct defe ct or mislabe ling will be made b y Medtronic N eurosurger y, which deter mination will
be final.

Produc ts will not b e accepted for r eplacement o r credit if th ey have been in po ssession of t he custome r for more than 9 0 days.

Warranty

A. Stand ard Limited Wa rranty. Medtronic Neurosurgery warrants to the original end user purchaser

(“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 fr ee from defe cts in mater ial and workma nship. Medtr onic Neurosu rgery makes
no warra nty (expres s, implied or st atutory) fo r Product s that are modif ied (except as e xpressly co ntemplated
herein) or su bjected to u nusual physic al stress, mi suse, improp er operation , neglect, i mproper tes ting, 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 Medtro nic Neurosur gery’s sole li ability for b reach of the fo regoing
warran ty shall be, at Me dtronic Neur osurgery ’s sole option an d election , to replace the Pr oduct or cre dit
Purchas er for the net am ount actual ly paid for any su ch Product ; provided 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 Produ ct F.O.B. 125 Cremona
Drive, Go leta, Calif ornia 93117, U.S.A. or a s otherwis e designated b y Medtronic Ne urosurger y; and (iii) Med tronic
Neurosurgery is reasonably satisfied that the claimed nonconformities actually exist. Except as expressly provided
in this par agraph, Purc haser shall no t have the right to re turn Produ cts to Medt ronic Neurosu rgery wit hout
Medtronic Neurosurgery’s prior written consent.

C. Excl usion of Oth er Warrantie s. EXCEPT FOR THE LI MITED WARRANTY PR OVIDED IN (A) ABOVE,
MEDTRONIC NEU ROSURGERY GRANT S NO OTHER WARRANTIES O R CONDITIONS, EXPR ESS OR IMPLIED
AND MANUFACTU RER SPECIFICALLY DISCL AIMS THE IMPLIED WARRAN TIES 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 ARI SING OUT OF OR
IN CONNECTI ON WITH THE SALE OR USE OF ANY P RODUCT.

PS Medical® external drainage and Monitoring catheterS

Caution: Consult Accompanying Documents

Sterilization: Ethylene-Oxide Gas

Use by

Package Contents

Do Not Reu se

Reference Number

Lot Number

InstructIons for use

Caution: For U.S. audiences only.

Cautio n: U. S. federa l law restr icts thi s device to sa le by or on the or der of a physi cian.

Manufacturer

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

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

[phone] USA/Canada
[phone] International
[phone] FAX USA/Canada
[phone] FAX International

17495-1 B

© Medtronic, Inc. 20 18

2018-12

PS Medical® External Drainage and Monitoring Catheters

Description

PS Medica l EDM Ventricular Ca theters, Bari um Impregna ted

PS Medic al® Becker® E DMS ventricu lar catheter, 20c m and EDM centri cular cathe ter, 35cm with Trocar p roducts
are fabricated from silicone elastomer tubing impregnated with barium sulfate to provide radiopacity. Relatively
firm t ubing is incor porated in the c atheter des ign to provide r esistance to c atheter kin king and compr ession. The
tip of the c atheter is bul let shaped and i s filled wit h radiopaque , tantalum-i mpregnate d silicone elas tomer. Black
length m arkers made of g raphite-i mpregnated s ilicone elas tomer are posi tioned on the c atheter at poi nts 5, 10
and 15cm fro m the proximal t ip to enable the s urgeon to gaug e the depth of pen etration of t he catheter i nto the
lateral ventricle.

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

PS Medica l Becker EDMS Ventric ular Catheter, 20cm , Barium Impreg nated

This devi ce consists o f a barium-im pregnated si licone elasto mer ventric ular cathete r, 20cm 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 latera l ventricle. Th e Luerlock con nector inc ludes a plug to f acilitate it s closure
prior to connection to other drainage or monitoring system components.

PS Medica l EDM Ventricular Ca theter, 35cm, Barium Imp regnated with Troc ar

This devi ce consists o f a barium-im pregnated si licone elasto mer ventric ular cathete r 35cm in length wi th 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 Cath eters are des igned for use a s the proximal co mponent for c erebrospin al fluid (CSF)
drainag e and/or monito ring from the l ateral ventri cles of the bra in.

Instructions for Use

A variet y of surgica l techniques m ay be used in plac ing the cathe ters into the la teral ventric le. The site of
placeme nt and techniq ues used are at t he discreti on of the surgeo n.

CAUTION: LOW T EAR STRENGTH IS A CHAR ACTERISTIC OF MO ST UNREINFORCED SILICO NE ELASTOMER
MATERIALS. C ARE MUST BE TAKEN WITH THE HAND LING AND PLACEMENT OF THE S ILICONE ELASTOM ER
CATHETER TUBI NG TO AVOID CUTS, NICKS OR T EARS.

Surgica l Technique – Ventricu lar Catheter

The foll owing surgic al technique f or placement o f the ventricu lar catheter h as 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 moni toring syst em should be com pletely 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
appropriate for an intracranial operation. A broad-spectrum antibiotic is administered preoperatively and
continued during the 24-hour postoperative period.

The head is c ompletely sh aved, cleaned an d prepared in a m anner approp riate for cra niotomy. Using loc al
anesth esia, a 2.5cm par asagitt al incision is m ade 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 ret racting the p eriosteum .

A twist d rill hole dir ected sligh tly mesially is m ade with a 9/64” bit . Under ideal co nditions, th e twist dril l should
penetr ate the dura wi thout injuri ng the underl ying brain. Th e dura may also be op ened with a #11 surgic al blade.

With the s tylet in pl ace, the tip of the v entricula r catheter c an be direct ed from the t wist drill h ole in the foll owing ways:

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

2) in a plane al igned 2cm anter ior to the ext ernal audito ry 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 contra lateral eye.
If the ipsi lateral ventr icle is not ente red, the physi cian may choos e to attempt ins ertion of th e ventricula r catheter
from th e opposite sid e of the patient ’s skull. Shoul d this also fail, t he surgeon may co nsider the alt ernative of
monitoring with a subarachnoid bolt
(e.g., Richmond Bolt).
The relat ive markers f or the incisio n
site and di rection fo r catheter in sertion
are illus trated in Fig ures 1a-b. If a
subarac hnoid bolt is t o be used, then
placing t he bolt in a new t wist drill
hole—to decrease the possibility of
clogging of the subarachnoid bolt with
brain tissue—is recommended.
When the ve ntricle is ent ered, the
style t is withdraw n and the cathe ter
is occlud ed at the scalp l evel by pinchin g with an appro priate clamp. O nly a minimal amo unt of CSF shoul d be
permit ted to escap e. This is part icularly im portant if t he ICP is not eleva ted.

CAUTION: OVERDRAINING MAY PREDISPOSE TO VENTRICULAR COLLAPSE, AND POTENTIALLY 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 wo und placed
posterior to the ventriculostomy incision.

The EDM Ventr icular Cath eter, 35cm, includ es a trocar whi ch may be used to f acilitate th is placement. T he trocar
may be inse rted into the d istal end of th e catheter fo r
attac hment. Afte r desired plac ement of the cat heter, 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
into the c atheter and at tached to oth er
components of the drainage and/or
monitor ing system . Specific d etails
regarding catheter connection are found
in the Ins truction s for Use for the B ecker
EDMS and EDM Kits.

Secure t he catheter t o the connec tor
with a dou ble suture ti e using 0 silk sutu re (Fig 2).

Care sho uld be taken to ens ure that the cat heter and
the balan ce of the draina ge and/or monito ring system
is fill ed and devoid of an y air bubbles. I f the cathete r
is prope rly placed, a sa tisfacto ry wavefor m should be
visible on the monitoring equipment. Minor adjustments
of the vent ricular cat heter positi on may be necess ary to
accomplish this.

After a s atisfac tory wavefo rm is
obtained, the ventriculostomy wound
is close d with interr upted sutur es and a
full hea d dressing app lied.

A silicon e fixation co llar may be appli ed
prior to co mpleting th e full head
dressi ng. Spread open t he collar (Fig 3a)
and posi tion the cath eter inside t he groove with in the collar (Fi g 3b). Then, secure t he fixati on collar to the s calp by
passin g a ligature thr ough the two h oles in the f lange of the f ixation coll ar (Fig 3c).

Description

EDM Lumbar Catheters, Barium Impregnated

The PS Med ical® EDM lumba r catheter, 24cm an d EDM lumbar cat heter, 80cm pro ducts are f abricated f rom
silicone elastomer tubing impregnated with barium sulfate to provide radiopacity. Relatively firm tubing is
incorp orated in the c atheter to prov ide resist ance to
kinking and compression. The open lumbar tips of the
EDM lumba r catheter, 24cm an d EDM lumbar cath eter,
Open Tip, 8 0cm, are trim med at an angle (F ig 4). The
lumbar ti p of the EDM lumba r catheter, clos ed tip, 80cm
is bullet- shaped and f illed with rad iopaque tan talum
impreg nated silicon e elastomer (Fi g 5). A PTFE-coate d
stainl ess steel gui dewire with a djustable s top is
provid ed with the clo sed tip 80cm ED M lumbar cathe ter to facili tate placemen t. All cathete rs have multip le inlet
holes lo cated withi n approximate ly 17 mm of the lumbar t ip. Length mark ers of graphi te impregnate d silicone
elasto mer are positi oned on the cat heters at poi nts 11, 16 and 21cm from the lumb ar tip (an additi onal 26cm
length m arker is includ ed on the 80cm ED M lumbar cathe ters).

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
catheter is aligned with the tip of the needle.

The lumbar catheter design, guidewire with adjustable stop (if included), and the 14-gauge Tuohy needle 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 l uer connect or with cap and a s ilicone elast omer strain r elief sleeve.

Indications

The EDM lum bar catheter s are designe d for use as the pr oximal compo nent for CSF dr ainage and/or mo nitoring
from the lumbar subarachnoid space.

Instructions for Use

A variet y of surgica l techniques 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.

Surgica l Technique — EDM Lumba r Catheter

The use of local or general anesthesia during the placement of the catheter is at the discretion of the surgeon.
Cathet er patency pr ior to implant ation should b e verified b y gently flus hing sterile s aline solut ion through th e

1a 1b

2

3a

1. To Patient
Monitoring
System

7. Scalp

3c

2. Suture

4. Luerlock Connector

3b

2. Suture

4

5

3. Fixation Collar

5. Catheter

6. Suture Hole

6. Suture Hole

2. Suture

8. Catheter
Exit Site

cathet er. A 20-gauge bl unt needle ada pter is provid ed with the EDM lu mbar cathet ers, 80cm fo r this purpos e. It
may be place d into the open e nd of the cathe ter to facilit ate flushin g.

NOTE: Refer to the “Guidewire and Adjustable Stop” section for instructions on proper guidewire use
during catheter implantation (EDM lumbar catheter, 80cm closed tip only).

Positio n the patient on o ne side with pa rtial hip and
knee f lexion (Fig 6). Pre pare and drape t he surgical a reas
(low back ) as a sterile f ield.

Make a 2cm inc ision betwe en the spinou s processes o f
L4-L5 or L 5-S1. Elevate the pat ient’s head abo ut 30° to
increa se intraspin al CSF pressu re. Insert th e 14-gauge
Tuohy needl e with the bevel c ephalad, and ad vance into
the lumbar subarachnoid space. Withdraw the needle
style t and lower the pa tient’s head w hen a free fl ow of
CSF is obt ained. Intro duce the lumba r catheter th rough
the Tuohy nee dle. Insert 8 cm of cathete r into the
subarac hnoid space ce phalad to the pun cture site. S lowly remove th e guidewire, i f used. Slowly r emove the Tuohy
needle, l eaving the cat heter in place. S ecure the cat heter with f ixation tab (s).

Proper c atheter plac ement in the lumb ar subarach noid 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. Occ lude cathete r with an appro priate
clamp or f inger pres sure to ensure th at as little C SF as possible i s lost. Prope r catheter pla cement allows lu mbar
subarachnoid drainage and pressure monitoring.

CAUTION: TO AVOID POSSIBLE TRANSECTION OF THE CATHETER, THE CATHETER SHOULD NEVER BE
WITHDRAWN TH ROUGH THE TUOHY NEED LE. IF THE CATHETER NEED S TO BE WITHDRAWN, THE TUO HY
NEEDLE AND CATHE TER (WITH GUIDEWIR E, IF USED) MUST BE REMOVED SIM ULTANEOUSLY.

Silicone elastomer fixation tabs are provided to anchor
the cath eter at the inci sion site, as des ired. The tab s
wrap aro und the cathe ter and can be loc ated at any
point. T he fixatio n tabs are appli ed to the cathe ter by
spreadi ng them open and p ositionin g the catheter i n
the fi xation tab gro ove (Fig 7a). The tabs are t hen closed
(Fig 7b). To secure t he fixatio n tab to the cath eter, a
suture i s passed thro ugh the two hol es in the tab and
tied. Th e tabs are then su tured to the ex posed fas cia at
the lumb ar incision. Th e catheter is le ft exter nalized at thi s point.

6

7a 7a

Using the Lu mbar Catheter St rain Relief

The lumb ar catheter s train relief i s fabricate d from
translu cent silicone e lastomer and i s designed to f it
secur ely over a Luerlo ck connecto r. The strain rel ief is
used with Medtronic Neurosurgery’s PS Medical lumbar
cathet ers to provid e support to an d lessen the po tential
of catheter kinking at the Luerlock connector junction.

Slide the s hort trans lucent strai n relief onto th e external
end of the c atheter narr ow end firs t (Fig 8a), so that the
flare d end of the stra in relief is dir ected towa rds the
end of the c atheter. The Lue rlock conne ctor may now be
inser ted into the cat heter. Slide the s hort trans lucent
Strain Re lief over the Lue rlock conne ctor (Fig 8b) and
verif y that the cath eter/connecto r junction i s intact.
Secure t he strain re lief and cathe ter to the conne ctor
with a tig ht suture tie in t he groove of the s train relie f,
using 0 sil k suture (Fig 8c). Th e plug attac hed to the
Luerlo ck connecto r may be used to pre vent loss of CSF
prior to a ttachment o f the cathete r to the patient l ine of
the drainage system.

8

10. Luerlock Cap

8b

8c

4. Luerlock
Connector

9. Strain
Relief

5. Catheter

2. Suture

Guidewire and Adjustable Stop

A PTFE-co ated stainl ess steel gui dewire with a djustable
stop is pr ovided with t he EDM lumbar ca theter, 80cm, cl osed tip, to inc rease the mane uverabilit y of the silicon e
cat heter.

To use the adju stable sto p, loosen the lue r cap. Partly w ithdraw the gu idewire fr om the dispens er. Pass the
flex ible tip of the gu idewire thr ough the Luer f itting of th e adjustabl e stop, out the ro unded end, and i nto the
connector end of the lumbar catheter. Thread the guidewire through the connector end of the catheter so that
the guid ewire contac ts the fil led tip of the lum bar catheter. Sl ide the adjust able stop so th at the rounde d end is
touchin g the connec tor end of the cat heter. Tighten t he cap to aff ix the adjus table stop to t he guidewire. D iscard
the guidewire dispenser.

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

Using the i ncluded Luer lock connec tor, the EDM lumba r catheter may b e directly a ttached to a t he Becker EDMS or
EDM drainage assembly.

NOTE: Ther e is slight r esistanc e to flow cau sed by the lum bar draina ge cathete r. The average re sistance
to flow a t a constant f low rate of 23 m L/hour is 0.1cm H
flow may r esult in a re duction o f system pr essure as co mpared wi th actual i n vivo pressure.

O per cm of c atheter le ngth. This r esistan ce to

2

Needleless Injection Site

The Inter link® injec tion site is si ngle use only. Do no t resterili ze.

1. Swab septu m of injectio n site with ant iseptic prio r to access.

2. Access In terlink inje ction site (id entified b y a colored rin g) with Interli nk cannula (not su pplied).

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 CANNULA IS STILL CONNECTED TO INTERLINK INJECTION SITE.

How Supplied

PS Medica l EDM Ventricular a nd Lumbar Cathe ters; Needlel ess Injectio n Site

The EDM Ventr icular and Lum bar Catheter s are supplie d as individu al product s, sterile and n on-pyroge nic in
double w rap package s. The Interli nk injectio n site is provid ed sterile. Th ese produc ts are intend ed for single (one ­time) use on ly. Do not use if pac kage has been p reviously op ened or damage d. Do not reste rilize. Rest erilizatio n
can damag e the produc t, potential ly leading to pat ient injury. Me dtronic Neu rosurger y is not respons ible for the
perf ormance of any pr oduct whic h has been rest erilized.

Special Order Products

If this Ins tructio ns for Use accomp anies a speci al order prod uct, there w ill possibly b e differen ces in the physi cal
characteristics between the product enclosed and the product description in this product package inser t. These
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 steril e or non-ster ile as indicat ed on the produ ct package l abel. Non­steril e product s must be cleane d and sterili zed prior to us e.

Patient Education

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
drainage and monitoring. This should include a description of associated complications, and an explanation of
potential alternative products and treatments.

Contraindications

Intrac ranial press ure monitori ng with a ventr icular or lumb ar catheter is c ontraindic ated in patie nts receivi ng
anticoa gulants or wh o are known to have a b leeding diat hesis. The vent ricular cat heter is contr aindicate d if scalp
infection is present. A patient undergoing external drainage and monitoring must be kept under continuous,
close su pervisio n. The use of a ventr icular or lumb ar drainage c atheter is cont raindicat ed where trai ned 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 cathe ter for drainag e and monitor ing of cerebro spinal flui d is not recomme nded for pati ents
with non-communicating hydrocephalus; where lumbar puncture is contraindicated; in the presence of large
intrac ranial mass le sions, tumor s, hematomas o r cysts; 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 emonstrat ed
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 co nditions fo r external dr ainage and mon itoring is at th e discretio n of the
physician.

Monitoring pressure from the lumbar subarachnoid space can be done only in instances where lumbar puncture
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
complications to the patient and/or his representatives prior to proceeding with any surgical procedures.

Failure to ap propriatel y adjust the ra te of CSF outf low through t he externa l drainage sy stem may result i n
potentially serious injury to the patient.

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

Improp er use of instr uments in han dling or implan ting EDM Cathe ter produc ts may result in t he cutting , slitting,
breaka ge or crushing o f component s. Such damage ma y lead to a loss of sy stem integr ity, 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 ov erdrainage o r underdrain age. Inadequa te 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 exte rnal drainag e system 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 overdrainage or underdrainage, and potentially serious injury to the patient.