Exacta External Drainage and Monitoring System
Description
The Exac ta external drainage and monitoring system (EDMS) is a complete system
for externally draining and monitoring cerebrospinal fluid (CSF) and monitoring
intracranial pressure (ICP) a s shown in F igure 1. The system includes a reusable
I.V. pole clamp/pressure scale assembly and a disposable patient line/drip chamber
assembly.
The threaded pole clamp (1) secures the scale (2) to 9.5 mm – 31.8 mm diameter
I.V.pole.The clamp assembly has a pressure scale marked in cm H
and an optional laser-leveling device (3) for establishing zero-reference between
system and patient.
The disposable drainage assembly includes a graduated drip chamber (4) with stopcock
and microbial barrier air vent; a nondistensible color-striped patient connection line (6)
with stopcock (7); a main system stopcock (5) that attaches to the I.V. pole clamp; and a
removable drainage bag (8) and stopcock (9) with approximate volumetric graduations
and microbial barrier vent. The entire drip c hamber assembly slides onto the I.V. pole
clamp assembly and is secured in place with a thumbscrew (10).
Note: The total accurac y of the graduated drip chamber is ± 10% or ± .5 mL,
whichever is greater.
1
(2) Reusable
Pressure
Scale
(4) Graduated
Cylinder
(5) Main Line
Stopcock
(1) Reusable
Threaded
Pole Clamp
(7) Patient Line
Stopcock
(6) Patient
Connection
Line
Indications
Draining and monitoring of CSF flow from the lateral ventricles or lumbar
subarachnoid space is indicated in selec ted patients to:
1. Reduce ICP, e.g., pre-, intra- or postoperative.
2. Monitor CSF chemistry, cytology, and physiology.
3. Provide temporary CSF drainage in patients with infected cerebrospinal fluid
shunts.
Monitoring of ICP is indicated in selected patients with:
1. Severe head injur y.
2. Subarachnoid hemorrhage graded III, IV or V pre operatively.
3. Reyes syndrome or similar encephalopathies.
4. Hydrocephalus.
5. Intracranial hemorrhage.
6. Miscellaneous problems when drainage is to be used as a therapeutic maneuver.
Monitoring c an also be used to evaluate the status pre- and postoperatively for spaceoccupying lesions.
Contraindications
Intracranial pressure monitoring wit h a ventricular or lumbar catheter is
contraindicated in patients receiving anticoagulants or who are known to have
a bleeding diathesis. The use of a ventricular catheter is contraindicated if scalp
infection is present. A patient undergoing external drainage and monitoring must be
kept under continuous, close supervision. The use of a ventr icular or lumbar drainage
catheter, or an Exacta System, is contraindic ated where trained personnel are not
available to supervise monitoring and drainage on a 24-hour-a-day basis.
The use of a lumbar catheter for drainage and monitoring of cerebrospinal f luid is not
recommended for patients with non-communicating hydrocephalus; where lumbar
puncture is contraindicated; in the pre sence of large intracranial mass lesions, tumors,
hematomas, or c ysts; in the presence of infections in the surrounding area, which
includes the skin, subcutaneous tissue, bone and the epidural space; and patients
which have demons trated blockage of cerebrospinal f luid to the subarachnoid space
due to trauma, hematoma, frac ture or tumor. The use of a lumbar catheter under these
conditions f or external drainage and monitoring is at the discretion of the physic ian.
Monitoring pressure from the lumbar subarachnoid space can be done only in instances
where lumbar puncture does not pose a danger to the patient.
Warnings and Precautions
Failure to appropriately adjust the rate of CSF out flow through the ex ternal drainage
system may result in potentially serious injury to the patient.
If using the optional laser level device, take care not to aim the laser into the eye.
Damage to the eye could result.
Patients undergoing external drainage and/or intracranial pressure monitoring must be
kept under constant supervision in an intensive care unit staffed with trained personnel
familiar wit h the use of intracranial an d lumbar pressure monitor ing techniques. Improp er
vigilance or improper drainage system setup can lead to overdrainage or underdrainage
and potentially serious injury to the patient. Intracranial and lumbar pressure monitoring
has been asso ciated with intracra nial infection, menin gitis and ventriculitis . The risk of
infect ion is probably influ enced both by the number of tim es a system is opened and by
the duration o f the monitoring. Prolong ed steroid therapy can als o increase the risk of
infection.
It is possible that the puncture of the ventr icle or the opening of the dura will result in
an intracranial hemorrhage.
It is possible that if too much CSF is removed from the ventricle s, either during a
drainage procedure or when the ventricle is f irst punctured, the ventricle may collapse
O and mm Hg,
2
(10) Thumbscrew
(3) Reusable
(8) Drainage
(9) Drainage Bag
Stopcock
LaserLeveling
Device
Bag
and occlude the catheter.
It is possible that the monitoring system may give a false pressure reading either due
to a pressure line becoming clo gged or kinked or from an air bubble lodged in the
system. An incorrect pressure reading may lead to the wrong therapy being given to
the patient. The irrigation of the catheter may induce pressure waves in the patient.
For this reason, irrigation should be done only by, or on the order of, a physician.
In order to minimize the possibility of infection, meningitis or ventriculitis, several
steps should be observed. First, the injection sites should always be cleaned with
alcohol or a disinfectant containing alcohol and the 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.
Leakage from the system, which can result from damage d system components or
improper use or handling, can potentially result in overdrainage, the need to replace
the drainage system and/or other complications to the patient.
All connections should be finger 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 perform a drainage maneuver against a positive pressure
head on the order of 20 cm H
subarachnoid space is first punctured during the inser tion of the catheter, care should
be taken so as lit tle CSF as possible is lost.
A double suture tie with silk suture should be used to secure the ventricular or lumbar
catheter to the connection fit ting. Check to ensure that the connection is tight prior
to use.
Whenever irrigation of the catheter or the performance of the Volume Pressure
Relationship ( VPR) is decided upon, great care must be used so that pressure waves are
not initiated. Only a small volume of s aline should ever be injected into the ventricular
system, and this only done by, or on the order of, a physician. In general, in monitor ing
ICP, one should always be aware of the waveform on the oscilloscope. If the waveform
begins to dampen out, it is important that the entire monitoring system be examined.
Ensure that the line to the patient is not kinked and that all air bubbles, blood or other
debris are removed from the s ystem. Check to ascertain that the tr ansducer is on the
same level as the patient’s ventricular system to ensure the proper reference level in
the manometer t ube for use in calibration procedures. Pressure monitoring with the
manometer may result in overdrainage of the ventricles.
O (15 mm Hg). In addition, when the ventricle or lumbar
2
Instructions for Use
System Setup
Prior to placing the ventricular or lumbar catheter, prepare system under sterile
conditions per the following:
2
2a
1. Attach pole clamp assembly to I.V. pole and tighten threaded bolt (Fig 2).
2. If using a laser leveling device – Point laser leveling device at the external
reference point, the patient’s Foramen of Monro, or lumbar catheter exit site.
Using care not point into the patient’s eyes, press and release the laser power
indicator. The laser beam will appear for 30 seconds once activated. Using
the levelers located on both the top and bottom of the laser-leveling device,
adjust alignment until the bubble rests in between the parallel lines (Fig 3).
If not using laser leveling device – Visually align.
If alignment is incorrect, loosen clamp handle and slide ass embly up or down
until desired level is achieved. Tighten bolt and reverif y that system is level.
CAUTION: IF USING LASER LEVEL DEVICE, TAKE CARE NOT TO AIM THE LASER
3
INTO EYES. DAMAGE TO THE PATIENT’S EYE COULD RESULT.
3. Slide drip chamber onto the pole clamp assembly (Fig 4a), clip main line
stopcock to zero-reference mount on pole clamp assembly (Fig 4b), and tighten
thumbscrew at the desired pressure setting.
CAUTION: ENSURE THAT ALL CONNECTIONS ARE TIGHT AND LEAK-FREE.
Assembled system should appear as shown in Figure 1.
Calibrate transducer sys tem using approved hospital procedures prior to connecting to
patient. Transducers and transducer adapters (not included) may be used to connec t
4a
4b
the Exacta System to pressure monitoring equipment.
Using a 20 to 30 mL syringe with a 25- gauge needle, inject sterile isotonic s aline
solution at patient line injection site until all air has been flushed f rom the colorstriped patient connection line. Ensure that fluid drains from the flow chamber into
the drainage bag.
The pressure head scales are referenced to zero at the main line s topcock. The main
line stopcock must be correctly aligned with the p atient for accurate monitoring.
Connecting Catheter to System
Set patient line and main line stopcocks to ensure CSF flow to the drip chamber.
Remove vented plug f rom the patient line. Pinch or clamp catheter to minimize
CSF loss during connection; attach the catheter to the patient line via the Luer-lock
connector. Make sure there are no air bubbles in the patient line. To establish flow,
remove the clamp (if used) from the catheter.
Setting the Pressure Head
Loosen thumbscrew, slide drip chamber until the pressure indicator wings indicate the
desired pre ssure setting (mm Hg or cm H
NOTE: Assuming the main line stopcock is level to the refer ence point on
the patient, an accurate pressur e head is obtained when the tubing from
the patient to the drip chamber is completely filled w ith fluid. If not, the
pressur e head is equal to the height of the meniscus of the fluid in the
tubing, as r eferenced to the zer o level of the system.
CAUTION: THE FLOW CHAMBER OF THE EX ACTA SYSTEM CAN BE POSITIONED
BELOW 0 CM H
ALLOW OVERDRAINAGE OF CSF IF NOT MONITORED CAREFULLY.
O. THIS WILL RESULT IN A NEGATIVE PRESSURE HEAD, AND MAY
2
O), and tighten the thumbscrew.
2
Monitoring Pressure with Transducer
Position patient line and main line s topcocks so that the catheter communicates to the
transducer adapter, whether placed on the patient line stopcock or main line stopcock.
Simultaneous drainage and pressure monitoring may result in artifacts in measured
pressure. For more accurate pressure monitoring, the system can be temp orarily
closed to the drip chamber by adjusting the main line or patient line stopcock so the
drainage catheter communic ates only with the pressure transducer.
CAUTION: IF SYSTEM STOPCOCKS ARE TEMPORARILY CLOSED, THEY SHOULD BE
OPENED TO RE-ESTABLISH CSF DRAINAGE.
Monitoring CSF Flow
Set patient line and main line stopcocks to allow CSF to flow to the drip chamber. Close
drip chamber stopcock to s top flow to drainage bag. Record fluid accumulation over
time per graduations (mL CSF) on drip chamber.
CAUTION: WITH THE DRIP CHAMBER STOPCOCK CLOSED, CSF WILL NOT FLOW
INTO THE DRAINAGE BAG. ALLOWING THE DRIP CHAMBER TO FILL COMPLETELY
WILL RESULT IN IMPROPER DRAINAGE.
To empty the drip chamber, set the drip chamber stopco ck’s “OFF” position to the
injection site.
CAUTION: FAILURE TO OCCLUDE THE PATIENT LINE WITH THE MAIN LINE STOPCOCK
BEFORE EMPTY ING DRIP CHAMBER MAY RESULT IN A MOMENTARY REDUCTION IN
SYSTEM PRESSURE, AND/OR OVERDR AINAGE OF CSF FROM THE PATIENT.
Needleless Injection Site – Instructions for Use
The Interlink injection site is single use only. Do not resterilize.
1. Swab septum of injec tion site with antiseptic prior to access.
2. Access Interlink injection site (identified by a colored ring) with Interlink cannula
(not supplied).
3. Replace every 24 hour s or per institutional protocol.
This produc t does not contain natural rubber latex.
CAUTION: IF NEEDLE MUST BE USED, INSERT SMALL GAUGE NEEDLE INTO
PERIMETER OF SEPTUM.
CAUTION: DO NOT DISCONNECT ADMINISTRATION SET, SYRINGE OR OTHER
COMPONENT FROM CANNULA WHILE C ANNULA IS STILL CONNECTED TO
INTERLINK INJECTION SITE.
Flushing the System
Injection sites may be used to flush the components of the fluid path.
CAUTION: ADJUST STOPCOCK S APPROPRIATELY TO ISOLATE PATIENT AND
PRESSURE TRANSDUCER WHILE FLUSHING SYSTEM. INJURY TO PATIENT AND
DAMAGE TO THE TRANSDUCER MAY OCCUR IF THE SYSTEM IS FLUSHED WITH AN
OPEN PATH TO PATIENT AND/OR TRANSDUCER.
1.5 Main System Stopcock
Dead End Plug
(Transducer Site)
Patient Line
Communicates with
Main System and
Dead End Plug
(Transducer Site)
A B C D
Patient Line
Communicates with
Dead End Plug
(Transducer Site)
Patient Line
Communicates with
Main System Only.
Dead End Plug
(Transducer Site)
Patient Line Does Not
Communicate with
Main System Nor
Dead End Plug
(Transducer Site)
Dead End Plug
(Transducer Site) Only.
Dead End Plug
(Transducer Site)
17487COM-1
manuals.medtronic.com
medtronic.com
(901) 396-2698 FAX Internati onal
(800) 468- 9713 FAX USA/Cana da
(901) 344-06 45 International
(800) 468- 9710 USA/Canad a
Goleta, California 93117-5500 USA
125 Cremona Drive
Medtronic Neurosurgery
Design Facility:
Minneapolis, MN 55432-5604 USA
710 Medtroni c Parkway NE
Medtronic, Inc.
1.7 Patient Line Stopcock
Patient’s Catheter
Communicates with
Main System Stopcock
(Transducer)
To Main System
Stopcock
Patient Line
Injection
Site
To Patient
Catheter
A B C D
Patient’s Catheter
Communicates with
Main System Only
To Patient
Catheter
Draining CSF
CSF will drain via the drip chamber into the drainage bag. Make sure all s topcocks are
properly oriented to allow drainage into the bag. For further instructions on stopcock
orientation, see Figures 1.5 and 1.7.
CAUTION: WHEN THE SYSTEM STOPCOCKS ARE OPEN TO ALLOW FLOW INTO THE
DRAINAGE BAG, FLUID MAY ACCUMULATE IN THE CYLINDER CHAMBER BEFORE
EMPTYING. IT MAY BE NECESSARY TO MANIPULATE THE DRAINAGE BAG REFLUX
VALVE TO RE-ESTABLISH FLOW.
Replacing the Drainage Bag
Turn the drip chamber stopcock “OFF” position towar d the drainage bag to prevent
flow from the drainage bag connection line. Using sterile technique, disconnect the
drainage bag connection line from the drainage bag and dispose of in accor dance
with hospital guidelines. Connect a sterile Exacta drainage bag to the drainage bag
connection line and attach to bag holders.
CSF Sampling
Using a 25-gauge needle, CSF may be sampled through injection sites, whic h have
been cleaned and disinfec ted with alcohol. Only clean the injection site septum.
Exposing plastic components to alcohol or a disinfectant containing alcohol may
compromise their integrity. If sampling CSF from the bot tom cap of the drainage bag
stopcock , the sampling rate should not exceed 2 cc (cm3)/sec., or 30 cc (cm3)/15 sec.
Transporting a Patient
To move a patient undergoing exter nal drainage and/or monitoring with an Exac ta
System, keep the system corre ctly aligned with the patient. If it is not possible to move
the system in the upright position, do the following:
1. Ensure flow chamber has completely drained.
2. Isolate patient from the f low chamber by turning the patient line and main line
stopcock s’ “OFF” positions toward the patient.
3. Close drip chamber stopcock.
4. Move patient and system as required.
5. Realign and readjust system and stopcocks to initiate drainage when patient
reaches new location.
CAUTION: ALL STOPCOCKS ADJUSTED FOR PATIENT TRANSPORT MUST BE RETURNED
TO CORRECT POSITION TO RE-ES TABLISH PROPER CSF FLOW AND DRAINAGE.
FAILURE TO DO SO COULD RESULT IN UNDER- OR OVERDRAINAGE OF CSF.
Cleaning
Before each use, perform cleaning of I.V. pole clamp assembly by wiping with
isopropyl alcohol.
How Supplied
The drainage bag and drip chamber assembly of the Medtronic Neurosurgery
Exact a System are packaged sterile and nonpyrogenic and are intended for
single (one-time use) only. DO NOT RESTERILIZE THE DRAINAGE BAG OR DRIP
CHAMBER ASSEMBLY. DISCARD THESE ITEMS AFTER USE. Do not use if package
has been previously opened or damaged. Resterilization can damage the product,
potentially leading to patient injury. Medtronic Neurosurgery is not responsible for the
performance of any product that has be en resterilized.
The I.V. pole clamp assembly is packaged nonsterile and is intended for nonsterile
use. DO NOT STERILIZE I.V. POLE CLAMP ASSEMBLY. Do not use if package has been
damaged.
All above-mentioned products are provided separately.
Special Order Products
If these Instructions for Use accompany a special order product, there may be
differences in the physical charac teristics between the product enclosed and the
product description in these Ins tructions for Use. The se differences will not affect the
safety or eff icacy of the special order produc t.
Patient Education
It is the physician’s responsibilit y to educate the patient and/or their represent ative(s)
regarding external drainage and monitoring. This should include a description of
associated complications, and an explanation of potential alternative products and
treatments.
Patient’s Catheter
Communicates with
Injection Site
(Transducer Site) Only.
Patient’s Catheter Does Not
Communicate with
Main System Nor
This Injection Site.
To Patient
Catheter
Injection
Site
To Patient
Catheter
Complications
One major complication associated with ICP monitoring with a ventricular or lumbar
catheter is the risk of infection, particularly meningitis and ventriculitis. The incidence
of these infections c an be reduced by care in inser ting the ventricular catheter and
stabilizing it by passing it through a subgaleal tunnel bef ore it emerges. The lumbar
catheter should be stabilized by use of f ixation tabs. Wound infec tions may occur but
usually subside when the catheter is removed.
A second major complication associated with ventricular or lumbar drainage of CSF is
overdrainage, which can lead to intracranial hemorrhage and permanent neurological
defici t. Overdrainage can occur due to improper s ystem testing or setup, (resulting in
system leak age or inappropriate sys tem pressure head heights) or the lack of adequate
fluid replacements to the patient.
Frequent punc tures of the brain to ins ert the ventricular c atheter can predispos e
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 be come clogged with blood clots, brain tissue fragments, or
fibrinous debris.
In patients with small ventricles, the ventr icular walls may collapse around the tip
of the catheter resulting in obstruction and predisposing to tentorial herniation. It is
therefore extremely important to avoid excessive release of CSF before the c atheter is
attached to the patient line.
Returned Goods Policy
Product s must be returned in unopened packages, with manu facturer’s seals intac t to
be accepted for replacement or credit, unles s returned due to a complaint of product
defect or mislabeling. Determination of a product defect or mislabeling will be made
by Medtronic Neurosurger y, which determination will be f inal. Products will not be
accepted for replacement or credit if they have be en in possession of the cus tomer for
more than 90 days.
Warranty
A. Standar d Limited Warranty. Medtronic Neurosurgery war rants to the original
end user purchaser (“Purchaser”) that t he enclosed product (“Product ”) purchased by
Purchaser, at the time of delivery to Purchaser, shall be subs tantially free from defect s
in material and workmanship. Medtronic Neurosurgery makes no warranty (express,
implied or st atutory) for Products that are modified (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 designed, or use in any manner or medical
procedure for which the Products are not indicated.
B. Remedy. Purchaser’s exclusive remedy and Medtronic Neurosurgery’s sole liability
for breach of the foregoing warranty shall be, at Medtronic Neurosurgery’s sole option
and election, to replace the Product or credit Purchaser for the net amount actually
paid for any such Product provided that; (i) Med tronic Neurosurgery is notified in
writing within ninety (90) days after Purchaser’s receipt of t he Product that such
Product f ailed to conform, including a detailed explanation in English of any alleged
nonconformity; (ii) such Product is returned to Medtronic Neurosurgery within ninety
(90) days after Purchaser’s receipt of the Product F.O.B. 125 Cremona Drive, Goleta,
California 93117, U.S.A. or as otherwis e designated by Medtronic Neurosurger y; and
(iii) Medtronic Neurosurgery is reasonably satisf ied that the claimed nonconformities
actually exist. Except, as expressly provided in this paragraph, Purchaser shall not
have the right to return Produc ts to Medtronic Neurosurgery without Medtronic
Neurosurgery’s prior written consent.
C. Exclusion of Other Warranties. EXCEPT FOR THE LIMITED WARRANT Y
PROVIDED IN (A) ABOVE, MEDTRONIC NEUROSURGERY GRANTS NO OTHER
WARRANTIES OR CONDITIONS, EXPRESS OR IMPLIED AND MANUFACTURER
SPECIFICALLY DISCLAIMS THE IMPLIED WARRANTIES AND CONDITIONS OF
MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE. MEDTRONIC
NEUROSURGERY NEITHER ASSUMES NOR AUTHORIZES ANY OTHER PERSON TO
ASSUME ANY OTHER LIABILITIES ARISING OUT OF OR IN CONNEC TION WITH THE
SALE OR USE OF ANY PRODUCT.
a
© 2020 Medtronic, Inc.
2020 - 03
17487COM-1 E
North R yde, NSW 2113 Australi
97 Waterloo Rd
Medtro nic Australasia P ty Ltd
Australian Sponsor:
Exacta ExtErnal DrainagE anD Monitoring SyStEM
InstructIons for use
Cautio n
Consult Instructions for Use.
Sterilization: Ethylene-Oxide Gas
Use by
Package Contents
Do Not Reuse
Reference Number
Lot Number
Cautio n: U. S. federal law r estrict s this device f or sale by or on the o rder of a physic ian.
Manufacturer
Contains di(2-ethylhexyl)phthalate (DEHP)
Non-Sterile
Caution: Laser radiation. Avoid direct eye exposure.
Pow er, On
Follow Instructions for Use.
The foll owing is a trade mark or regis tered trade mark of Medtr onic, Inc. in th e United
States an d other countr ies: Exac ta™. All other trad emarks, ser vice mark s, registere d
tradem arks or regi stered ser vice marks a re the proper ty of their r espectiv e owners in
the United States and other countries.
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