Becker External Drainage and Monitoring System
Description
The Becke r External Dra inage and Monitori ng System (Becker EDMS ) provides the physi cian with a
complete closed system for:
1. Draining cerebrospinal uid (CSF) from the lateral ventricles of the brain or the lumbar
subarachnoid space.
2. Monitoring C SF pressure and ow r ate from the lateral ve ntricles of the br ain and the lumbar
subarachnoid space.
The Becke r EDMS (Fig. 1) consists of a non distensible blu e-striped (p roximal end) patie nt connection
line, patient line stopcock, mounting panel/main system section, two latex-free injection sites and a
removable drainage bag with approximate volumetric graduations and microbial barrier air vent.
1
Drainage Bag
Flow Chamber
Locking Bracket
Vent
Cord Lock
Flow Chamber
Arrow
Sliding Graduated
Drip Chamber
Slide Clamp
Drainage Line
Injection Site
Flow Chamber
Connection Line
Drainage Bag
Connection Line
Side Clamp
Vent and Drain
Port Cap
One-Way
Valve
Hanger Hole
System Mounting Panel
Instructions
for Use
Pressure Scales
Stopcock
Patient Line Stopcock
Injection Site (Optional
Transducer Adapter Location)
Vented Cap
Main System
Stopcock
Main System End Plug
(Optional Transducer
Adapter Location)
Patient Connection Line
The main system section located on the mounting panel includes:
1. Mounting bracket for height adjustment of system
2. Optional sel f-adjusting cord w ith lock for adjus tment of system h eight
3. Main system s topcock with op tional transduce r attachment lo cation
4. Sliding, gradu ated, 50 cc ow chamber wi th drip former an d conical bottom , and locking
bracket
5. Two drainage line slide clamps for ow monitoring and sampling
6. Drainage bag connection line
7. Instructions for Use
Note: System does not contain any latex components.
Indications
Draining a nd monitoring of C SF ow from the latera l ventricles or lum bar subarachnoi d space is
indicate d in selected pa tients to:
1. Reduce int racranial pres sure (ICP), e.g., pre-, intra- or p ostoperative;
2. Monitor CSF che mistry, cyt ology, and physiolog y;
3. Provide temporary CSF drainage in patients with infected cerebrospinal uid shunts.
Monitor ing of intracrani al pressure (ICP) is indi cated in selec ted patients wit h:
1. Severe head injury
2. Subarachnoid hemorrhage graded III, IV, or V preoperatively
3. Reyes syndrome or similar encephalopathies
4. Hydrocephalus
5. Intracranial hemorrhage
6. Miscellaneous problems when drainage is to be used as a therapeutic maneuver.
Monitor ing can also be used to e valuate the statu s pre- and postop eratively for spa ce-occupying
lesions.
Contraindications
Intracr anial pressure mo nitoring with a vent ricular or lumbar c atheter is contra indicated in pati ents
receivi ng anticoagulant s or who are known to have a bl eeding diathesi s. The use of a ventric ular
catheter is contraindicated if scalp infection is present. A patient undergoing external drainage and
monitor ing must be kept under c ontinuous, clos e supervision. T he use of a ventricul ar or lumbar
drainage c atheter, or a Becker EDMS, i s contraindicat ed where trained p ersonnel are not av ailable to
supervise monitoring and drainage on a 24-hour-a-day basis.
The use of a lumbar catheter for drainage and monitoring of cerebrospinal uid is not recommended
for patients with non-communicating hydrocephalus (1,2); where lumbar puncture is
contrain dicated; in the pre sence of large intra cranial mass lesi ons, tumors, hemat omas, or cysts (8);
in the pres ence of infecti ons in the surroun ding area which incl udes the skin, subc utaneous tissu e,
bone and th e epidural space; and p atients which have d emonstrated bl ockage of cerebro spinal uid
to the subar achnoid space due to t rauma, hematoma, fr acture or tumo r. The use of a l umbar catheter
under the se conditions fo r external drain age and monitorin g is at the discreti on of the physician.
Monitor ing pressure fro m the lumbar subara chnoid space can be d one only in instanc es where
lumbar pun cture does not p ose a danger to the pat ient (8).
Warnings and Precautions
Failure to appr opriately adjus t the rate of CSF out ow through the ex ternal drainag e system may
result in potentially serious injury to the patient.
Patients undergoing external drainage and/or intracranial pressure monitoring must be kept under
constan t supervision i n an intensive care uni t staed with tr ained personn el familiar with th e
use of intracranial and lumbar pressure monitoring techniques. Improper vigilance or improper
drainage system setup can lead to overdrainage or underdrainage and potentially serious injury
to the patie nt. Intracrania l and lumbar pressur e monitoring has be en associated wi th intracrania l
infection, meningitis and ventriculitis. The risk of infection is probably inuenced both by the
number of ti mes a system is ope ned and by the durati on of the monitorin g. Prolonged ster oid
therapy c an also increase th e risk of infecti on.
It is possib le that the punct ure of the ventricl e or the opening of the d ura will result in an in tracranial
hemorrhage.
It is possib le that if too much CSF i s removed from the ve ntricles, eithe r during a drainage p rocedure
or when the ve ntricle is rst p unctured, the v entricle may collap se and occlude the ca theter.
It is possib le that the monitor ing system may give a f alse pressure rea ding either due to a pr essure
line becom ing clogged or kin ked or from an air bub ble lodged in the sy stem. An incorrec t pressure
reading may lead to the wrong therapy being given to the patient. The irrigation of the catheter
or the per formance of a Volume Pr essure Relation ship (VPR) study may in duce pressure wave s in
the patie nt. For this reason, ir rigation or VPR st udies should be don e only by, or on the order of, a
physician.
In order to minimize the possibility of infection, meningitis or ventriculitis, several steps should be
obser ved. First, the in jection sites s hould always be clea ned with alcohol and t he alcohol allowed to
dry before a needle is inserted into them. Second, sterile technique should be observed in setting
up the system and in the placement of the catheter. Third, subgaleal tunneling of the ventricular
catheter should be approximately one to two inches.
In order to avo id possible crack ing of the luer conne ctors afte r cleaning with alco hol, or a
disinfectant containing alcohol allow to air dry completely prior to connecting the system.
All connections should be nger tightened. Over tightening can cause cracks and leaks to occur.
Leakage could result in complications such as patient infection, underdrainage or overdrainage, as
well as user infection.
In order to ensure against ventricular collapse and the possible consequence of tentorial herniation,
always per form a drainag e maneuver agains t a positive press ure head on the orde r of 20 cm H2O or
15 mm Hg. In additi on, when the ventri cle or lumbar subar achnoid space is r st punctur ed during the
inser tion of the cathe ter, care should be taken s o as little CSF as p ossible is lost.
A double su ture tie with silk su ture should be use d to secure the ven tricular or lumba r catheter to the
connec tion tting. C heck to ensure that t he connectio n is tight prior to us e.
Whenever ir rigation of the c atheter or the per formance of th e VPR is decided up on, great care mus t be
used so th at pressure waves ar e not initiated. On ly a small volume of sal ine should ever be inj ected into
the ventri cular system, an d this only done by, or on the o rder of, a physician. In g eneral, in monitor ing
intracr anial pressure, o ne should always be aw are of the wave form on t he oscilloscop e. If the wave
form beg ins to dampen out, it i s important t hat the entire moni toring system b e examined. Ensur e
that the lin e to the patient is not k inked and that all air b ubbles or blood o r other debris are re moved
from the s ystem. Check to a scertain that t he transducer is o n the same level as the p atient’s ventri cular
system to e nsure the proper r eference level in t he manometer tub e for use in calibr ation procedur es.
Pressur e monitoring wit h the manometer may re sult in overd rainage of the ve ntricle s.
Instructions for Use
Prior to us e of the Becker EDMS, it is n ecessary for t he attending phy sician and other res ponsible
personnel to familiarize themselves with the use and function of the various components of the
system . The following guid elines have been pre pared by Dr. Donald P. Becker* and hi s sta.
System Setup
The syst em should be prepar ed under sterile co nditions at leas t 30 minutes prior to pla cement of the
ventricular catheter or lumbar catheter. The system should be removed from the opened pouch by
an attend ant wearing a surgic al face mask and ster ile gloves. Check to e nsure that all compon ents
are assem bled. Check compo nents for damage p rior to use.
CAUTION: CHECK ALL CO NNECTIONS TO ENSURE THAT FITTINGS ARE TI GHT AND LEAK-FREE.
CAUTION: CHECK VE NTS FOR DAMAGE. DO NOT BLOCK VE NTS.
A pressur e transducer adapt er and transducer may b e attached to th e patient line stop cock or to
the main sy stem stopcock . See Figures 2 and 3. If el ectronic pre ssure monitorin g equipment is to be
used, at tach transduce r to transducer adapt er located on pati ent line or main syst em stopcock.
NOTE: Transducer adapters and transducers are not included with this system.
To attach a pr essure transduc er adapter at the main sy stem stopcock , remove end plug. The p lug may
then be use d to cap a secondar y inlet on the trans ducer adapter if nec essary. To attach a tr ansducer
adapter at the patient line stopcock, remove injection site cap.
The syst em mounting panel i ncorporates a hang er hole and braide d cord with lock for I .V. pole
suspensi on and a panel bracket f or manifold pole c lamp mounting if mo re rigid mounting i s desired.
Locate th e system mountin g panel so that the main s ystem stopcoc k is level with the pat ient’s
foramen o f Monro or at the level of t he exit of the lumba r catheter. Ensure that p anel is properly
aligned. T he pressure head sc ales found on the p anel label are refe renced to zero at the mai n system
stopcoc k. The main syste m stopcock must b e correctly ali gned with the pati ent for accurate pr essure
monitoring.
Pre-Filling the System
The syst em must be pre-ll ed to the ow chamber dr ip former with s terile isotonic s aline solution
prior to connecting to patient.
Use of a 20 to 30 mL sy ringe with a 25- gauge needle is rec ommended.
Inject at patient line stopcock injection site until all air has been ushed from patient line stopcock,
patient line, main system stopcock, and ow chamber connection line into drip chamber.
Transducer adapter, end plug, and injection site ttings may be momentarily loosened to allow air
to escap e.
Check sy stem for any residu al air bubbles. Air c an be removed by combin ed injection of s aline and
aspirati on of air via a 25-gau ge needle at injec tion site on the pat ient line stopcoc k.
Ensure tha t uid drains from t he ow chamber into the d rainage bag. It may be n ecessary to
manipulate the drainage bag connection line or drainage bag one-way valve to establish drainage.
To Connect Ca theter to System
After th e catheter has been p roperly placed, t he luerlock conne ctor is inser ted into the cathet er. Care
should be t aken to allow only a minima l amount of CSF to esca pe. The catheter may b e occluded at
the scalp l evel or at lumbar cath eter exit site by pin ching or with an appr opriate clamp to mini mize
uid loss during the insertion of the connector.
The Becke r EDMS Ventricular Cat heter, 20 cm, EDM Lumbar Cath eter, 24 cm, and EDM L umbar
Cathete r, 80 cm, avail able separately, incl ude a catheter luer lock connecto r with an integral mo lded
plug. This p lug may be used to plug th e catheter prior t o connection to th e patient line. The EDM
Ventricula r Catheter, 35 cm include s a separate end plug to a llow temporary c losure. EDM Catheter s
with BioG lide include a sepa rate end plug.
To connect th e catheter to the pre -lled system, s et the patient line s topcock as shown i n Fig 2.3.
Remove the en d plug from the pati ent line.
The cathe ter should now be occl uded with an appro priate clamp (if not al ready in place) to minimiz e
CSF loss du ring connecti on to the system. (De tach the plug fro m the catheter luer lock connecto r if
used.) Att ach luerlock conn ector to patient l ine. Care should be ta ken to ensure that the ca theter and
complete s ystem is devoid of any a ir bubbles.
Set the pat ient line stopcoc k to the desired set ting (see System Co ntrol). Remove the clamp f rom the
catheter. If included, the integral molded plug on the catheter luerlock connector should then be
removed (cut o ).
System Control
To Set Pressure Head
Turn the thumb s crew of locking br acket to unlock. Sli de ow chamber arro w to desired pressu re
setti ng (in cm H2O or mm Hg) on sys tem mounting pan el. Lock ow chamber i n place using thumb
scr ew.
NOTE: An accu rate pressur e head is obtaine d only when the tu bing from the pa tient to
the flo w chamber drip f ormer is compl etely fluid f illed. If the tub ing is not compl etely
fluid f illed, the pr essure head is eq ual to (in cm H2O) the heigh t of the meniscu s of the
fluid i n the tubing, as re ferenced to th e zero level of the s ystem (see “System S etup”).
CAUTION: THE FLOW CHA MBER OF THE BECKER EDMS CAN BE POSITI ONED BELOW 0 cm
H2O. SUCH POSITIONING WI LL RESULT IN A NEGATIVE PRESSURE HEAD, AND MAY RESULT IN
OVERDRAINAGE O F CSF IF NOT MONITORED VIGILA NTLY.
Patient Line Stopcock
The patient line stopcock is regularly positioned as depicted in Fig. 2.
When at “Off” position:
Fig. 2.1: Cathet er communicates wi th main system st opcock and patien t line stopcock
inject ion site (or transduce r adapter). This is the regu lar setting for s ystem use.
Fig. 2.2: Cat heter communica tes with the main sy stem stopcock on ly. Catheter does not
communicate with patient line stopcock injection site (or transducer adapter).
Fig. 2.3: Cath eter communicate s with patient line s topcock injec tion site (or transdu cer
adapter). Catheter does not communicate with main system stopcock.
Fig. 2.4: Cath eter does not commu nicate with patie nt line stopcock in jection site (or
transdu cer adapter), or main sys tem stopcock.
2.1
O Position
2.3
* This product was developed in cooperation with Donald P. Becker, M.D., Department of Surgery, Division of Neurosurgery,
University of California, Los Angeles School of Medicine, Los Angeles, CA 90024.
To Main System Stopcock
Patient Line
Injection Site
(or Transducer Adapter)
To Patient Catheter
O Position
2.2
O Position
2.4
O Position
Main System Sto pcock
The main sy stem stopcock may b e positioned as de picted in Fig. 3.
When at “Off ” position:
Fig. 3.1: Patient line commun icates with tran sducer adapter (if co nnected) and ow
chamber. This is the regular setting for system use (drainage).
Fig. 3.2: Patient line communicates with transducer adapter (if connected) only. Patient line
does not co mmunicate with ow c hamber.
Fig. 3.3: Patient line communicates with ow chamber only. Patient line does not
communicate with transducer adapter.
Fig. 3.4: Patient line does not communicate with transducer adapter. Patient line does not
communicate with ow chamber.
3.1
(1) O Position
(2) To Flow Chamber
(4) Main System End Plug
(Optional Transducer
Adapter Location)
(3) To Patient Line Stopcock
3.3
3.2
(1) O Position
3.4
Australian Sponsor:
Medtronic Australasia Pty Ltd
5 Alma Road
Macquaire P ark, NSW 2113 Austr ali
Medtronic, Inc.
710 Medtroni c Parkway NE
Minneapolis, MN 55432 USA
Design Facility:
Medtronic Neurosurgery
125 Cremona Drive
Goleta, C alifornia 93117 USA
(800) 468- 9710 USA /Canada
(901) 344- 0645 International
(800) 468- 9713 FAX USA /Canada
(901) 396-2698 FAX Inter national
medtronic.com
manuals.medtronic.com
(1) O Position
(1) O Position
© 2020 Medtr onic, Inc.
a
16811COM-1F
2020 - 03
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INSTRUCTIONS
F
OR
U
SE
Review Instructions
for Use prior to system
use.
S
YSTEM
S
ET
-
UP
• Secure main system to I.V. pole
• Align main system stopcock
with Patient’s Foramen of Monro
OR Exit of Lumbar Catheter.
• Attach the Pressure Tranducer
to the Main System Stopcock
(remove the end-plug).
•OR attach the Pressure
Transducer to the Patient Lin
e
Stopcock (remove injection
site).
• Prefill system using sterile
technique. Use a 25-ga.
needle to fill patient line to
drip chamber with sterile
normal saline at patient line
injection site. Verify the
absence of leaks and air
bubbles.
S
YSTEM
C
ONTROL
•To Set Pressure Head , slide
the drip chamber arrow to the
desired pressure setting.
• CSF Drainage to Flow
Chamber. First, open the
Main System Stopcock, then
open the Patient Line
Stopcock.
• CSF Drainage from Flow
Chamber to Drainage Bag.
Open BOTH large drainage
line slide clamps.
For Pressure
Monitoring and Patient
Transport, refer to
Instructions For Use.
F
LOW
M
ONITORING
•Shut off flow chamber to
collection bag with proximal
drainage line slide clamp.
•Open both stopcocks so that
the patient line
communicates with the flow
chamber.
•Record the fluid
accumulation.
w
w
B
e
c
k
e
r
E
D
M
S
I
I
Mai
n System
Stopc
ock
Patien
t Line
Stopc
ock
M
a
d
e
in
t
h
e
U
S
A
.
Medtronic PS Medical
125
Cremo
na Driv
e
Goleta
• CA •
93117
• US
A
The ow cham ber will communica te with the drainag e bag when both slide c lamps are open or
loosely p ositioned. This p osition is illust rated in Fig. 4.1.
The ow cham ber will not communi cate with the drain age bag when either s lide clamp is closed o r
positioned to compress and securely occlude the drainage bag connection line (Figures 4.2 and 4.3).
The slide cl amp position shown i n Fig. 4.2 is used to sam ple CSF from the ow c hamber. The slide
clamp posi tion shown in Fig. 4.3 is u sed to monitor the ow rate in the graduate d chamber.
4.1 4.2 4.3
Open
Open
Closed
Closed
Open
To Calibrate System
To calibrate the transducer, follow the instructions of the transducer manufac turer.
Initial system calibration should be done prior to connecting system to patient.
The syst em provides sever al ways to perfor m the calibratio n. The transducer lo cated on the patie nt
line stop cock, or on main sys tem stopcock, m ay be referenced to at mospheric pres sure through the
vent on the ow c hamber. This can be don e to zero the transduc er.
Needleless Injection Site—Instructions for Use
1. Swab septu m of injection sit e with antiseptic p rior to access.
2. Access Interlink injection site (identied by a colored ring) with Interlink cannula (not
supplied).
3. Replace ever y 24 hours o r per instituti onal protocol.
This prod uct does not cont ain natural rubbe r latex.
Precautions
If needle m ust be used, inser t small gauge need le into perimeter of s eptum.
Do not disconnect administration set, syringe or other component from cannula while cannula is still
connected to Interlink injection site.
Single use only. Do not resterilize
CAUTION: DO NOT B LOCK OR DAMAGE VENT.
The ow cham ber connectio n line may be used as a mano meter tube. The tran sducer is then
referenced to the saline solution-lled connection line. The saline solution in the connection line
can be main tained at a constan t height and provide s a readily accessib le standard pre ssure against
which to calibrate the transducer.
To set the pres sure, align the ow cham ber inlet tube wit h the desired pres sure setting on t he cm
H2O or mm Hg scal e. The scale is locat ed on the system mo unting panel adjace nt to the ow chamber
slide. A pres sure setting o f 27.2 c m H2O or 20 mm Hg is rec ommended for tra nsducer calibrat ion.
To Drain CSF
Open pati ent line stopcock a nd main system sto pcock to allow uid to ow from the drainag e
catheter to the ow chamber. Open the proximal drainage line slide clamp and the distal drainage
line slide c lamp to allow uid to ow fr om the ow chamber to t he drainage bag.
The amount a nd rate of drainage wi ll be partially de pendent on the sys tem pressure head s etting
(the height of t he ow chamber arro w relative to the main s ystem stopcock z ero level).
CAUTION: DURING S YSTEM USE WITH THE FLOW CHAMBER SLIDE CL AMP(S) OPEN TO ALLOW
FLOW INTO THE DRAINAGE BAG , FLUID MAY ACCUMULATE IN THE FLOW CHA MBER BEFORE
EMPTY ING. FLOW MUST BE CAREFULLY MONITORED TO PREVEN T COMPLETE FILLING OF THE
FLOW CHAMBER. IT MAY BE NECE SSARY TO MANIPULATE THE DRAINAGE BAG CONN ECTION
LINE TO RE-ESTABLISH DRA INAGE FROM THE FLOW CHAMBER TO THE DRAINAGE BAG .
COMPLETE FILLING OF THE FLOW CHA MBER WILL PRECLUDE DRAINAGE OF CSF.
NOTE: When th e drainage line s lide clamps ar e open, allowing f low into the dra inage
bag, a smal l accumulatio n of fluid may col lect in the fl ow chamber bef ore emptyin g.
When the periodic fluid accumulation empties, a slight momentary reduction (0 to 4 cm
H2O) in syste m pressure may oc cur.
To Monitor Pressure
Position patient line and main system stopcock so that the ventricular catheter or lumbar catheter
communicates to transducer adapter.
Simultan eous drainage and p ressure monitor ing may result in ar tifacts in me asured pressure a s
descri bed by Wilkinson (60). If mor e accurate pressu re monitoring is de sired, the syste m should
be temporarily closed to drainage by adjusting the patient line stopcock (Fig. 2.3) or main system
stopcoc k (Fig. 3.2) so that the drai nage catheter com municates only wi th the pressure tr ansducer.
CAUTION: IF SYS TEM STOPCOCKS ARE TEMPO RARILY CLOSED TO ALLOW FOR MORE ACCURATE
PRESSURE MONITOR ING, CARE MUST BE TAKEN TO ADJUST THE SYST EM AND RE-ESTABLISH
CSF DRAINAGE . FAILURE TO READJUST THE SYSTEM WILL PREC LUDE DRAINAGE OF CSF.
To Monitor Flow
Set patie nt line stopcock an d main system sto pcock to allow uid to co mmunicate to ow cham ber.
Slide drip chamber up, aligning ow chamber arrow with desired pressure setting.
Close dra inage line proximal s lide clamp to stop ow to t he drainage bag. Re cord uid accumulat ion
over time pe r graduations (in mL) on ow chamber.
CAUTION: WIT H THE PROXIMAL DRAI NAGE LINE SLIDE CLAMP C LOSED TO MONITOR FLOW, THERE IS N O
FLOW INTO THE DRA INAGE BAG. FLOW MUST BE CARE FULLY MONITORED TO PREVENT CO MPLETE FILLING
OF THE FLOW CHAMB ER. COMPLETE FILLING OF FLOW C HAMBER WILL PRECLUDE DR AINAGE OF CSF.
To empty the ow c hamber, set main sys tem stopcock to “O FF” (see Fig. 3.4), then open drainage
line slide c lamps (see Fig. 4.1). When the ow chamber i s emptied, reset ma in system stopc ock to
desired p osition (see Fig. 3).
CAUTION: FAILURE TO ADJUST M AIN SYSTEM STOPCOCK TO ISO LATE PATIENT FROM FLOW
CHAMBER DURING EM PTYING MAY RESULT IN A MOMENTARY REDUC TION IN SYSTEM
PRESSURE.
To Flush System
Inject ion sites may be used t o ush the system. Flu sh uid into drainag e bag.
CAUTION: ADJUST PATIENT LINE OR M AIN SYSTEM STOPCOCK TO ISO LATE PATIENT AND
PRESSURE TRAN SDUCER. INJURY TO PATIENT AND DAMAGE TO THE TR ANSDUCER MAY OCCUR
IF THE SYSTEM IS FLUSHED WI TH AN OPEN PATH TO PATIENT AND/OR TRANSDUC ER.
To Replace Drainage Bag
Close dis tal drainage line sl ide clamp to prevent re trograde ow fr om the drainage bag c onnection
line. Remove the bag from the system mounting panel. Using sterile handling technique to avoid
contamination, disconnect the drainage bag connection line from the drainage bag. Discard
drainage bag in accordance with hospital medical waste guidelines.
Connect sterile Medtronic Neurosurgery Drainage Bag to the drainage bag connection line and
attach to system mounting panel.
CAUTION: THE DR AINAGE LINE SLIDE CLAMP MUST BE RESE T TO OPEN POSITION TO ESTABLISH
FLOW INTO THE DRAINAGE BAG . COMPLETE FILLING OF FLOW CHAMBER WILL PRECLUDE
DRAINAGE OF C SF.
CAUTION: AVOID TWI STING DRAINAGE BAG CONNECTION LIN E DURING BAG REPLACEMENT.
THIS MAY CAUSE KINKING .
CAUTION: IF LUER CONNEC TORS ARE CLEANED WITH ISOPR OPYL ALCOHOL OR A
DISINFECTANT CONTAINING ALCOHOL DURING THE REPLACEMENT PROC EDURE, ALLOW TO
AIR DRY COMPLETELY PRIOR TO RECONNECTION.
To Empty Drainage Bag
Center for Disease Control (CDC) guidelines advocate minimizing exposure to body uids. Therefore,
replacement of the drainage bag is recommended by Medtronic Neurosurgery. However, should the
physician c hoose to empty an d reuse the drainag e bag, the following m ethod may be used:
1. Remove the bag from the system mounting panel. Do not disconnect the drainage bag from
ow chamber connection line.
2. Using sterile handling techniques, disconnect the vented port cap from the luerlock tting.
3. With careful attention to avoid contamination of the open luerlock tting, invert bag and
empty.
4. Using sterile handling technique replace port cap.
CAUTION: IF POR T AND/OR CAP HAVE BEEN CLEANED WITH ALCOHOL , ALLOW TO AIR
DRY COMPLETELY BEFORE REPL ACING CAP.
5. Reattach bag to system mounting panel.
Irrigation, CSF Sampling, and Intraventricular Medication
The syst em’s latex-free injec tion sites can be u sed for several pu rposes. A 25-g auge needle can be
inser ted through an injec tion site which h as been cleaned and d isinfected wi th alcohol. A clogg ed
ventricular catheter may then be irrigated with 0.1 mL of sterile saline. Similarly, the injection
site can be u sed to withdraw a sa mple of CSF for labor atory analysis o r to inject intrave ntricular
medication.
Open
Volume/Pressure Relationship
A volume/pr essure relations hip (VPR) can be obta ined with the sys tem using the techni que
descri bed by Miller et al, and Ma rmarou and Shulman. F ill a 1.0 mL syringe with a n attached
25-gauge needle with sterile isotonic saline and insert the needle through patient line injection site.
Physician s desiring to conduc t these studi es should be familia r with the techniqu es as describe d by
Miller et al, an d by Marmarou and Shul man.
Moving an EDMS Patient
If it is desi red to move a patient who i s undergoing ex ternal drainage an d/or monitoring wit h a
Medtro nic Neurosurger y Becker EDMS, the sy stem should be kept up right and correc tly aligned wit h
the patie nt. If it is not possib le for the system to b e moved in an upright ma nner, the following ste ps
must be pe rformed:
1. Ensure that the ow chamber has completely drained.
2. Isolate patien t from communica tion with the ow cha mber by:
a. Adjusting the patient line stopcock to “OFF” (Fig 2.3 or 2.4)
b. Adjusting mai n system stopco ck to “OFF” (Fig 3.4)
3. Move patient an d system as requir ed.
4. Realign and readj ust system, sto pcocks, and slid e clamps to initiate dr ainage when patie nt
reaches new location.
CAUTION: ALL STOP COCKS AND SLIDE CLAMPS AD JUSTED FOR PATIENT TRANSPORT MUST BE
RETURNED TO THEIR NO RMAL POSITION TO RE-ESTABLISHED PRO PER FLOW AND DRAINAGE
OF CSF. FAILURE TO PROPERLY RE-ADJUST THE STOPCOC KS AND SLIDE CLAMPS COULD RES ULT
IN UNDER- OR OVERDR AINAGE OF CSF.
CAUTION: FAILURE TO PERFOR M STEPS 1-4 ABOVE, MAY RESULT IN IMPROPER VENTIN G BY
FLOW CHAMBER VENT WHEN D RAINAGE IS RE-ESTABLISHED.
How Supplied
The Medt ronic Neurosurge ry Becker EDMS is pa ckaged sterile and non-pyrogenic and is inten ded
for single (one-time) use only. DO NOT RES TERILIZE. DISCARD AFTER USE .
Do not use if p ackage has been pr eviously opene d or damaged. Do not res terilize. Rester ilization
can damage the product, potentially leading to patient injury. Medtronic Neurosurgery is not
respons ible for the perf ormance of any prod uct which has bee n resterilized.
Special Order Products
If this Ins tructions fo r Use accompanies a spe cial order produ ct there will pos sibly be dierenc es in
the physic al characteri stics betwe en the product en closed and the pro duct descri ption in this data
sheet. Th ese dierences w ill not aect the s afety or eca cy of the special o rder product .
Special o rder product s may be supplied ste rile or nonsterile as indicate d on the product pa ckage
label. Nons terile produc ts must be clean ed and sterilized p rior to use.
Patient Education
It is the phys ician’s responsibili ty to educate the p atient and/or their rep resentative(s) reg arding
exter nal drainage and mon itoring. This shou ld include a descr iption of associ ated complicatio ns, and
an explanation of potential alternative products and treatm ents.
Complications
One major co mplication ass ociated with ICP mon itoring with a vent ricular or lumbar c atheter is
the risk of infection, particularly meningitis and ventriculitis. The incidence of these infections can
be reduce d by care in insert ing the ventricul ar catheter and st abilizing it by pass ing it through a
subgaleal t unnel before it e merges. The lumba r catheter should b e stabilized by use o f xation tabs.
Wound infections may occur but usually subside when the catheter is removed.
A second maj or complication a ssociated with v entricular or lumb ar drainage of CSF is ove rdrainage,
which can lead to intracranial hemorrhage and permanent neurological decit. Overdrainage can
occur due to i mproper syste m testing or setup (re sulting in syste m leakage or inappr opriate system
pressure head heights) or the lack of adequate uid replacements to the patient.
Frequent punctures of the brain to insert the ventricular catheter can predispose to intracerebral
hemorrhage and edema causing a further rise in ICP.
Poor recording of ICP will result if the catheter, patient line or other components of the monitoring
system b ecome clogged wi th blood clots, b rain tissue frag ments, or brino us debris.
In patient s with small ventri cles, the ventric ular walls may collapse a round the tip of the c atheter
resulting in obstruction and predisposing to tentorial herniation. It is therefore extremely important
to avoid exces sive release of CSF b efore the cathe ter is attached to t he patient line.
Returned Goods Policy
Produc ts must be retur ned in unopened p ackages, with man ufacturer ’s seals int act to be accepted
for replac ement or credit, u nless returned d ue to a complaint of pro duct defec t or mislabeling.
Determi nation of a produc t defect or misl abeling will be made by M edtronic Neuro surgery, which
determi nation will be nal. Pr oducts will not b e accepted for repla cement or credit i f they have been
in posse ssion of the custom er for more than 90 day s.
Warranty
A. Standa rd Limited Warr anty. Medtronic Ne urosurgery wa rrants to the ori ginal end user
purchaser (“Purchaser”) that the enclosed single use product (“Product”) purchased by Purchaser,
at the time of d elivery to Purch aser, shall be substant ially free from d efects in mate rial and
workmans hip. Medtronic Neu rosurgery make s no warranty (exp ress, implied or s tatutory) for
Produc ts that are modi ed (except as express ly contemplated her ein) or subjected to un usual
physical stress, misuse, improper operation, neglect, improper testing, use in combination with
other pro ducts or compo nents other than th ose for which the Pr oducts were de signed, or use in any
manner or medical procedure for which the Products are not indicated.
B. Re medy. Pu rchaser’s exclusi ve remedy and Medtr onic Neurosurge ry’s sole liabilit y for breach of
the fore going warranty s hall be, at Medtroni c Neurosurgery ’s sole option and ele ction, to replace
the Produ ct or credit Purc haser for the net am ount actually pa id for any such Produc t; provided tha t
(i) Medtro nic Neurosurger y is notied in wri ting within nine ty (90) days after Purc haser’s receipt
of the Prod uct that such Prod uct failed to con form, including a d etailed explan ation in English of
any alleged nonconformity; (ii) such Product is returned to Medtronic Neurosurgery within ninet y
(90) days afte r Purchaser’s recei pt of the Product F.O.B. 125 Cremona D rive, Goleta, Cali fornia 93117,
U.S.A. or as ot herwise desi gnated by Medtroni c Neurosurger y; and (iii) Medtroni c Neurosurgery i s
reasonab ly satised tha t the claimed noncon formities ac tually exist. E xcept as expressl y provided
in this par agraph, Purchase r shall not have the right to r eturn Produc ts to Medtronic N eurosurgery
without Medtronic Neurosurgery’s prior written consent.
C. Exclu sion of Other War ranties. EXCEP T FOR THE LIMITED WARRANTY PROVID ED IN (A)
ABOVE, MEDTRONI C NEUROSURGERY GRANTS NO OTHER WARR ANTIES OR CONDITIONS,
EXPRESS OR IMPLIED AND MANUFACTURER SPECIFICALLY DISCLAIMS THE IMPLIED
WARRANTIES AND CONDITIONS OF MERCHANTABILITY AND FITNESS FOR A PARTICUL AR
PURPOSE. MEDTRONIC NEUROSURGERY NEITHER ASSUMES NOR AUTHORIZES ANY OTHER
PERSON TO ASS UME ANY OTHER LIABILITIES ARISING OUT OF O R IN CONNECTION WITH THE
SALE OR USE OF ANY PRODU CT.
Becker® external Drainage anD Monitoring SySteM
InstructIons for use
Caution
Consult Instructions for Use.
Sterilization: Ethylene-Oxide Gas
Use by
Package Contents
Do Not Reuse
Do Not Resterilize
Reference Number
Lot Number
Cautio n: U. S. federal law re strict s this device fo r sale by or on the o rder of a physic ian.
Manufacturer
Contains di(2-ethylhexyl)phthalate (DEHP)
The foll owing are tra demarks o r register ed tradema rks of Medt ronic, Inc . in the United
States an d other count ries: Bec ker®, and BioG lide®. All other tr ademark s, servic e marks,
regist ered trade marks or re gistered s ervice ma rks are the p ropert y of their re spectiv e
owners i n the United St ates and othe r countrie s.
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