Catheter Access Port Kit 8543
for use with Medtronic Implantable Infusion Pumps
Instructions for Use
Rx only
Explanation of symbols on product or package labeling
Refer to the appropriate product for symbols that apply.
Open here
Do not reuse
Sterilized using ethylene oxide
-XX °C
-XX °F
XXX °F
LOT
EO
Consult instructions for use
Use by
Date of manufacture
XX °C
Temperature limitation
Lot number
Volume
STERILE
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Medtronic, IsoMed, and Medtronic logo are trademarks of Medtronic.
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Table of contents
Introduction 7
Package contents 7
Indications 7
Contraindications 7
Warnings 7
Precautions 9
Adverse events 10
Instructions for Use 10
Preliminary procedures 10
Preparing the access site 10
Intrathecal applications only 11
Flushing the catheter access port 12
Technical support 13
Emergency procedures 14
Morphine intrathecal overdose 14
Emergency procedure to empty pump reservoir 16
Special notice 17
Limited Warranty 18
Medtronic® Neuromodulation MODEL 8543 CATHETER ACCESS PORT
KITS LIMITED WARRANTY (U.S. Customers Only) 18
Refer to the indications, drug stability, and emergency procedures
reference manual for indications and related information.
Refer to the appropriate information for prescribers booklet for
contraindications, warnings, precautions, adverse events summary,
individualization of treatment, patient selection, use in specific
populations, and component disposal.
Refer to the appropriate drug labeling for indications,
contraindications, warnings, precautions, dosage and administration
information, and screening procedures.
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Introduction
These instructions include only the procedure for accessing the catheter via
the catheter access port. Refer to the appropriate pump technical manual for
implanting instructions and pump indications, contraindications, warnings,
precautions, and adverse events.
Package contents
The Model 8543 Catheter Access Port Kit (CAP kit) contains the following
sterile components that are not made with natural rubber latex:
Extension set with a clamp
▪
0.2-micron filter
▪
24-gauge noncoring needles with purple color (2)
▪
10-mL syringe
▪
Fenestrated drape
▪
Template (1)
▪
Indications
The Model 8543 Catheter Access Port Kit is intended for use in accessing the
catheter via the catheter access port of Medtronic implantable IsoMed pumps.
Contraindications
Medtronic catheter access port kits are contraindicated for all refill
procedures.
Warnings
Advancing drug to catheter tip (intrathecal applications) - For intrathecal
applications, do not inject drug directly into the catheter or through the
catheter access port to advance drug to the catheter tip. Injecting through the
catheter access port or injecting directly into the catheter to advance drug to
the catheter tip can result in a clinically significant or fatal drug overdose.
Calculating catheter volume - Use the catheter length recorded at implant
or catheter revision when calculating catheter volume. The actual implanted
catheter length and catheter model number are required to accurately
calculate catheter volume. A universal value does not exist that can be used
as a substitute for this knowledge. An inaccurate catheter volume calculation
can result in a clinically significant or fatal drug underdose or overdose.
Catheter access port kit components - The appropriate Medtronic catheter
access port kit MUST be used during all catheter access port procedures for
Medtronic implantable infusion pumps. Using components other than
Medtronic components or a kit other than the appropriate catheter access
port kit can damage Medtronic components, requiring surgical revision or
replacement, and allow drug leakage into surrounding tissue, resulting in
tissue damage or loss of or change in therapy, which may lead to a return of
underlying symptoms, drug withdrawal symptoms, or a clinically significant or
fatal drug underdose.
Catheter aspiration (intrathecal applications) - During intrathecal
applications, before injecting fluids through the catheter access port, aspirate
approximately 1 to 2 mL from the catheter (unless contraindicated). A
significant amount of drug may be present in the catheter access port and
catheter, and failure to remove the drug during catheter access port injections
can result in a clinically significant or fatal drug overdose.
Connections - Firmly secure all connections. Failure to secure connections
can allow drug to leak onto the surrounding skin and may result in inadequate
therapy or infection.
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Contrast medium - When injecting contrast medium into the intrathecal
space, use ONLY contrast medium indicated for intrathecal use. Using
nonindicated contrast media can result in adverse events including, but not
limited to, extreme pain, cramps, seizures, and death. Inject contrast medium
through the catheter access port only.
Drug information - Refer to the appropriate drug labeling for indications,
contraindications, warnings, precautions, dosage and administration
information, and screening procedures. Refer to the appropriate drug labeling
for specific drug underdose or overdose symptoms and methods of
management. Failure to refer to the drug labeling can result in inappropriate
patient selection and management, inadequate therapy, intolerable side
effects, or a clinically significant or fatal drug underdose or overdose. Consider
the possibility of a drug error if the patient experiences unusual side effects.
Failure to do so can result in misdiagnosis of patient symptoms.
Drug interaction and side effects - Inform patients of the appropriate
warnings and precautions regarding drug interactions, potential side effects,
and signs and symptoms that require medical attention, including prodromal
signs and symptoms of inflammatory mass. Failure to recognize the signs and
symptoms and to seek appropriate medical intervention can result in serious
patient injury or death.
Drug overdose symptoms and management - Refer to the emergency
procedures included at the end of this manual and the appropriate drug
labeling for specific drug overdose symptoms and methods of management.
Drug underdose/overdose - Inform patients and caregivers of the signs and
symptoms of a drug underdose and overdose. Inform patients and caregivers:
to be aware and report any unusual signs or symptoms at any time
▪
during or after a refill or catheter access port procedure.
to be alert for any burning sensations in the area of the pump pocket
▪
during their refill or catheter access port procedure.
to especially watch for signs of underdose and overdose.
▪
to stay alert for signs or symptoms that may indicate changes to their
▪
prescribed drug concentration.
to seek emergency assistance as necessary. For emergency
▪
procedures associated with drug underdose and overdose, refer to the
refill kit or catheter access port kit manual or the indications, drug
stability, and emergency procedures manual.
Failure to recognize these signs and symptoms and to seek appropriate
medical intervention can result in serious patient injury or death.
Implantation and system management - Implantation and ongoing system
management must be performed by individuals trained in the operation and
handling of the infusion system and must be in compliance with procedures
described in the appropriate technical instructions. Inadequate training or
failure to follow instructions can require surgical revision or replacement, and
result in a clinically significant or fatal drug underdose or overdose.
Injection error during a catheter access port procedure - Be certain you
are accessing the correct port when injecting fluids into the catheter access
port of an implanted pump. ALWAYS:
identify the pump model.
▪
identify the location of the catheter access port.
▪
use the instructions, noncoring needles, template, and other
▪
accessories provided in the appropriate kit.
verify the location of the correct port during needle insertion according
▪
to the instructions provided AND using other medical procedures as
appropriate.
refer to the appropriate drug labeling for indications, contraindications,
▪
warnings, precautions, adverse events, and dosage and
administration information.
Pocket fill is the improper injection into the subcutaneous tissue, which
includes the pump pocket, during a catheter access port injection.
Pocket fill can result in significant tissue damage or a loss of or change
in symptom control, drug withdrawal symptoms, or a clinically significant
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or fatal drug underdose or overdose. Observe the patient after the
catheter access port injection for any signs or symptoms that could
indicate a pocket fill or any other drug-related adverse event. Seek
emergency assistance as necessary. Refer to the CAP kit manual or
the indications, drug stability, and emergency procedures manual for
emergency procedures associated with drug underdose and overdose.
Inadvertent injection into the reservoir fill port can result in changes
to the drug concentration and drug content in the pump reservoir,
resulting in a clinically significant or fatal drug underdose or overdose.
Injection of fluids such as contrast media into the reservoir fill port may
result in permanent system damage leading to a clinically significant or
fatal drug underdose or overdose.
Intrathecal therapy - For intrathecal therapy, use ONLY a preservative-free
sterile solution indicated for intrathecal use. Nonindicated fluids containing
preservatives or endotoxins can be neurotoxic in intrathecal applications.
Using nonindicated fluids can result in adverse events including, but not
limited to, extreme pain, cramps, seizures, and death.
User instructions - Comply with all product instructions for initial preparation
and filling, implantation, refilling, and accessing the catheter access port (if
present) of the pump. Failure to comply with all instructions can lead to
technical errors or improper use of implanted infusion pumps and result in
additional surgical procedures, a return of underlying symptoms, drug
withdrawal symptoms, or a clinically significant or fatal drug underdose or
overdose.
Precautions
Aseptic technique - Use strict aseptic technique when accessing the
reservoir fill port or the catheter access port of an implanted pump. Failure to
use aseptic technique can contaminate fluids or tissues and result in local or
systemic infection.
Catheter access port filter - Always use a bacterial-retentive filter when
injecting through the catheter access port. The catheter access port does not
contain a filter. Injecting into the catheter without using a filter can
contaminate fluids or tissues and result in local or systemic infection.
Catheter access port injections - Do not use excessive force, do not use
syringes smaller than 10 mL and do not rock the needle sideways when
accessing the catheter access port. Using excessive force or syringes smaller
than 10 mL can cause the catheter to detach or rupture, resulting in leakage
into tissue, into the pump pocket, or along the catheter track. Rocking can
break the needle, resulting in leakage into tissue or pump pocket or needle
fragments lodging in the patient and requiring surgical revision or
replacement of the pump or additional surgery to remove needle fragments
from the patient.
Compatibility, all components - Follow these guidelines when selecting
system components:
Medtronic components: For proper therapy, use only components
▪
that are compatible with the appropriate indication.
Non-Medtronic components: No claims of safety, efficacy, or
▪
compatibility are made with regard to the use of non-Medtronic
components with Medtronic components. Refer to the non-Medtronic
documentation for information.
Component packaging - Before shipment the components in the sterile
package were sterilized by the process indicated on the package label. Do
not use or implant a component if the following circumstances have occurred:
The storage package or sterile seal has been pierced or altered
▪
because component sterility cannot be guaranteed and infection may
occur.
The component shows signs of damage because the component may
▪
not function properly.
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The use-by date has expired because component sterility cannot be
▪
guaranteed and infection may occur; also, device battery longevity
may be reduced and may require early replacement.
Infection - Use extreme caution when accessing the reservoir fill port or
catheter access port of the implanted pump if local or systemic infection is
suspected. Avoid contaminating the system or further spreading the infection.
Local or systemic infection may require pump revision or removal.
Single use only - Do not reuse any component. Components are intended for
single use only. Reusing components can result in inadequate therapy and an
increased risk of infection.
Storage temperature: kits and accessories - Do not store or transport the
kit device components or accessories above 57 °C (135 °F) or
below –34 °C (–30 °F). Temperatures outside this range can damage device
components.
Adverse events
The adverse events associated with the use of this device may include, but
may not be limited to, the following:
Meningitis (intrathecal applications)
▪
Infection
▪
Injection into pocket or subcutaneous tissue
▪
Instructions for Use
Become thoroughly familiar with all product literature before using catheter
access port kits.
Sterilization
All components of the kit are sterile. Do not resterilize. Should sterility of the
kit be in question, discard and use a new kit.
Preliminary procedures
Gather the following sterile equipment:
For IsoMed pumps, the Model 8543 Catheter Access Port Kit:
Extension set with clamp
▪
0.2-micron filter
▪
10-mL empty syringe (for aspirating in intrathecal applications)
▪
Fenestrated drape
▪
24-gauge noncoring needle
▪
Template
▪
Locally supplied:
Syringe containing prescribed fluid (10-mL syringe minimum)
▪
Syringe with 5 mL saline (for flushing if desired)
▪
Cleansing agent
▪
Sterile gloves
▪
Alcohol pads or swabs
▪
Adhesive bandage, optional
▪
Preparing the access site
1. Identify the pump model, reservoir volume, and location of the catheter
access port.
2. Prepare the injection site by cleansing the area.
3. Open the kit. Put on sterile gloves.
4. Place the drape, exposing the pump site.
5. Place the template over the pump, aligning the edges of the template
with the edges of the pump. Locate the catheter access port.
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Intrathecal applications only
Warning:
Pocket fill is the improper injection into the subcutaneous tissue, which
includes the pump pocket, during a catheter access port injection.
Pocket fill can result in significant tissue damage or a loss of or change
in symptom control, drug withdrawal symptoms, or a clinically significant
or fatal drug underdose or overdose. Observe the patient after the
catheter access port injection for any signs or symptoms that could
indicate a pocket fill or any other drug-related adverse event.
Inadvertent injection into the reservoir fill port can result in changes
to the drug concentration and drug content in the pump reservoir,
resulting in a clinically significant or fatal drug underdose or overdose.
Injection of fluids such as contrast media into the reservoir fill port may
result in permanent system damage leading to a clinically significant or
fatal drug underdose or overdose.
1. Using sterile procedures, assemble the needle, extension set, and
empty syringe (Figure 1).
2. Close the clamp and gently insert the needle into the catheter access
port until the needle touches the needle stop (Figure 1).
Closed clamp
Extension set
Te mp l at e
Needle
Catheter access port
Empty syringe
Figure 1. Close the clamp and insert the needle into the catheter access
3. Open the clamp and aspirate approximately 1-2 mL to ensure removal
of drug from the catheter access port and catheter. Refer to the
specifications in the appropriate catheter technical manual for the
catheter volume.
4. Close the clamp and remove the syringe.
Note: Keep the needle in the catheter access port and the clamp closed
for the procedure that follows.
5. Purge the air from the syringe containing the prescribed fluid.
6. Attach the filter to the syringe with the prescribed fluid.
7. Purge all air from the filter.
8. Attach the syringe with the filter to the extension set (Figure 2).
9. Open the clamp and inject the drug at an infusion rate not greater than
5 mL per minute (Figure 2).
port.
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Te mp l at e
Open clamp
Syringe with prescribed fluid
Filter
Needle
Catheter access port
Figure 2. Open the clamp and inject into the catheter access port.
10. During injection, check the needle puncture site for swelling. Swelling
may indicate that the needle tip is in the pump pocket and not in the
catheter access port.
11. When the drug has been injected, close the clamp, and carefully remove
the syringe.
12. Proceed to "Flushing the catheter access port" on page 12.
Extension set
Flushing the catheter access port
Warning:
Pocket fill is the improper injection into the subcutaneous tissue, which
includes the pump pocket, during a catheter access port injection.
Pocket fill can result in significant tissue damage or a loss of or change
in symptom control, drug withdrawal symptoms, or a clinically significant
or fatal drug underdose or overdose. Observe the patient after the
catheter access port injection for any signs or symptoms that could
indicate a pocket fill or any other drug-related adverse event.
Inadvertent injection into the reservoir fill port can result in changes
to the drug concentration and drug content in the pump reservoir,
resulting in a clinically significant or fatal drug underdose or overdose.
Injection of fluids such as contrast media into the reservoir fill port may
result in permanent system damage leading to a clinically significant or
fatal drug underdose or overdose.
1. If flushing is desired, attach a syringe containing 5 mL of sterile saline to
the extension set.
Note: Use a preservative-free solution.
2. Open the clamp and inject directly at an infusion rate not greater than 5
mL per minute.
3. During injection, check the needle puncture site for swelling. Swelling
may indicate that the needle tip is in the pump pocket and not in the
catheter access port.
Note: Flushing the catheter access port also flushes the drug from the
catheter. Drug therapy from the pump will be lost until the catheter is
refilled by the drug flow from the pump. Refer to the appropriate pump
technical manual for instructions on calculating the time required for
drug to advance to the catheter tip.
4. Upon completion of the flush, close the clamp, and carefully remove the
needle from the catheter access port.
5. Properly discard the needle.
6. Remove the cleansing agent from the patient's skin using an alcohol
pad.
7. Apply an adhesive bandage, if desired.
8. Discard all components of the kit.
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Technical support
A toll-free technical support service is available 24 hours a day for clinicians
managing patients with Medtronic implantable infusion pumps. Telephone
Customer Service at: 1-800-707-0933.
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Emergency procedures
Morphine intrathecal overdose
Consult the patient's medical record or with the patient's physician to
confirm the drug or drug concentration within the pump reservoir.
Symptoms
Respiratory depression with or without concomitant central nervous
system depression (ie, dizziness, sedation, euphoria, anxiety, seizures,
respiratory arrest).
Actions
See the following figure (Figure 3).
Respiratory resuscitation and intubation may be necessary.
Maintain airway/breathing/circulation.
Give naloxone 0.4 – 2 mg intravenously.
FOR INTRATHECAL OVERDOSE:
If not contraindicated, withdraw 30 – 40 mL of
CSF through the catheter access port or by lumbar
puncture to reduce CSF morphine concentration.
Use only a 24-gauge
(3.8 or 5.1 cm), needle for withdrawal from the
d
or smaller, 1.5 or 2.0 inch
catheter access port.
Empty pump reservoir to stop drug flow.
Record amount withdrawn.
Continue to monitor closely for symptom recurrence.
Since the duration of the effect of IV naloxone is
shorter than the effect of intrathecal and
subcutaneous morphine, repeated administration
may be necessary.
a
No Recurrence Recurrence
Repeat naloxone every 2 – 3 minutes to maintain
adequate respiration.
see naloxone package insert.
a,b
For continuous IV infusion,
a,b,c
FOR SUBCUTANEOUS
OVERDOSE:
(eg, pocket fill)
Proceed immediately
to the next step.
No ResponseResponse
Continue to perform
life-sustaining
measures.
b
If no response is observed after 10 mg of naloxone, the
diagnosis of narcotic-induced toxicity should be questioned.
Notify patient’s physician managing intrathecal pain therapy.
Figure 3. Morphine intrathecal overdose emergency procedures.
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a,b
a
Preservative-free morphine sulfate sterile solution manufacturer's
package insert.
b
Naloxone hydrochloride manufacturer's package insert.
c
Refer to the drug manufacturer's package insert for a complete list of
indications, contraindications, warnings, precautions, adverse events,
and dosage and administration information.
d
Use a 24- or 25-gauge needle for withdrawal from an IsoMed catheter
access port.
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Emergency procedure to empty pump reservoir
Equipment
22-gauge noncoring needle
▪
20-mL syringe
▪
3-way stopcock or extension set with clamp
▪
Antiseptic agent
▪
Caution: Do not use an open syringe when emptying the IsoMed Pump.
The pump reservoir contents are under significant pressure and can
eject through an open syringe when emptying the pump. Ejection of
pump contents under pressure can result in procedural delays and a
potential risk to the clinician or patient.
1. Assemble the needle, syringe, and stopcock or extension set.
2. Locate the pump by palpation. The reservoir fill port is located in the
CENTER of the pump.
If you have difficulty identifying the pump features, you may seek
assistance from another clinician. If deemed necessary by the clinician,
x-ray and fluoroscopy can be used to assist in locating or determining
the orientation of the pump.
3. Prepare the injection site by cleansing the area using an antiseptic
agent.
4. Gently insert the 22-gauge noncoring needle into the center of the
reservoir fill port until the needle touches the bottom of the reservoir fill
port (Figure 4).
During proper needle insertion, you will feel the needle:
pass through the patient's skin and subcutaneous tissue,
▪
hit the silicone septum,
▪
(Scar tissue, if present, can feel similar to the septum.)
pass through the septum, and
▪
hit the metal bottom of the reservoir fill port.
▪
(The top of the pump is metal and hitting the top of the pump can feel
similar to hitting the bottom of the reservoir fill port.)
If excessive resistance is encountered during needle insertion, reassess
placement. Do not force the needle. The feel of abnormal resistance
during the procedure may be an indication that the needle is not in the
center of the reservoir fill port.
Septum
Bottom of the
reservoir fill port
Figure 4. View inside of an IsoMed pump while the needle is fully and
5. Maintain light pressure on the syringe plunger when emptying the pump.
Open the clamp or stopcock and slowly withdraw the fluid from the
reservoir into the empty syringe. If backflow is not observed, remove the
needle from the reservoir fill port and repeat steps 2 – 5. If backflow still
16 English 2018-02-01
properly inserted.
Needle
Subcutaneous tissue
does not occur, and the Expected Volume is greater than 2 mL, contact
your Medtronic representative.
6. Depending on pump reservoir volume, more than one syringe may be
needed to empty the pump. Close the clamp or stopcock when
changing syringes.
7. Completely empty the pump. Wait approximately 5 seconds after fluid
stops flowing into the syringe to ensure that all fluid is removed and the
pump is empty.
8. Remove the needle from the reservoir fill port.
9. Record in patient chart the amount of fluid emptied from the pump
reservoir.
Special notice
The Medtronic Model 8543 Catheter Access Port Kit is designed to be used
for accessing the catheter access port of the Medtronic implantable IsoMed
pump. Medtronic cannot warrant or guarantee the catheter access port kit
because, despite the exercise of all due care in design, component selection,
manufacture, and testing prior to sale, the components of the catheter access
port kit may be easily damaged before or during use by improper handling or
other intervening acts.
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Medtronic® Neuromodulation
MODEL 8543 CATHETER ACCESS PORT KITS
LIMITED WARRANTY
A. This Limited Warranty provides the following assurance to the purchaser
of the Medtronic Model 8543 packaged herein, hereafter referred to as
the “Product”:
(1) Should the Product fail to function within normal tolerances due to a
defect in materials or workmanship prior to its "Use By" date,
Medtronic will at its option: (a) issue a credit to the purchaser equal
to the Purchase Price, as defined in Subsection A(2), against the
purchase of the replacement Product or (b) provide a functionally
comparable replacement Product at no charge.
(2) As used herein, Purchase Price shall mean the lesser of the net
invoiced price of the original, or current functionally comparable, or
replacement Product.
B. To qualify for this Limited Warranty set forth in Section A(1), the following
conditions must be met:
(1) The Product must be used prior to its "Use By" date.
(2) The unused portion of the Product must be returned to Medtronic
within thirty (30) days after discovery of the defect and shall be the
Property of Medtronic.
(3) The Product must not have been altered or subjected to misuse,
abuse, or accident.
(4) The Product must be used in accordance with the labeling and
instructions for use provided with the Product.
C. This Limited Warranty is limited to its express terms. In particular:
(1) Except as expressly provided by this Limited Warranty, MEDTRONIC
IS NOT RESPONSIBLE FOR ANY DIRECT, INCIDENTAL OR
CONSEQUENTIAL DAMAGES BASED ON ANY DEFECT,
MALFUNCTION OR FAILURE OF THE PRODUCT, WHETHER THE
CLAIM IS BASED ON WARRANTY, CONTRACT, TORT OR
OTHERWISE.
(2) This Limited Warranty is made only to the purchaser who uses the
Product. AS TO ALL OTHERS, MEDTRONIC MAKES NO
WARRANTY, EXPRESS OR IMPLIED, INCLUDING, BUT NOT
LIMITED TO, ANY IMPLIED WARRANTY OF MERCHANTABILITY
OR FITNESS FOR A PARTICULAR PURPOSE WHETHER
ARISING FROM STATUTE, COMMON LAW, CUSTOM OR
OTHERWISE. NO EXPRESS OR IMPLIED WARRANTY TO THE
PATIENT SHALL EXTEND BEYOND THE PERIOD SPECIFIED IN
A(1) ABOVE. THIS LIMITED WARRANTY SHALL BE THE
EXCLUSIVE REMEDY AVAILABLE TO ANY PERSON.
(3) The exclusions and limitations set out above are not intended to, and
should not be construed so as to contravene mandatory provisions of
applicable law. If any part or term of this Limited Warranty is held to
be illegal, unenforceable or in conflict with applicable law by a court
of competent jurisdiction, the validity of the remaining portions of the
Limited Warranty shall not be affected, and all rights and obligations
shall be construed and enforced as if this Limited Warranty did not
contain the particular part or term held to be invalid. This Limited
Warranty gives the purchaser specific legal rights. The purchaser
may also have other rights that vary from country to country or from
state to state.
1
(U.S. Customers Only)
1
This Limited Warranty is provided by Medtronic, Inc., 710 Medtronic Parkway,
Minneapolis, MN 55432-5604. It applies only in the United States. Areas outside the United
States should contact their local Medtronic representative for exact terms of the Limited
Warranty.
18 English 2018-02-01
(4) No purchaser has any authority to bind Medtronic to any
representation, condition or warranty except this Warranty.
2018-02-01 English 19
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Manufacturer
Medtronic, Inc.
710 Medtronic Parkway
Minneapolis, MN 55432-5604
USA
www.medtronic.com
Tel. 1-763-505-5000
Toll-free 1-800-328-0810
*M978794A001*
© Medtronic 2018
All Rights Reserved
M978794A001 Rev A
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