Medtronic 355531 Instructions for Use

Multi-lead Trialing Cable 355531

Trialing and intraoperative screening cable

Instructions for use

! USA

Rx only

2010

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

0123

! USA

EO

Caution, consult accompanying documents.

Consult instructions for use

Date of manufacture

Manufacturer

Use by

XX °C

Temperature limitation

XXX °F

Lot number

LOT

Conformité Européenne (European Conformity). This symbol
means that the device ful ly complies with MDD 93/42/EEC (NB

0123).

Authorized representative in the European community

REP

EC

For USA audiences only

STERILE

355531 2011-08 English 1

Medtronic® is a registered trademark of Medtronic, Inc.

2 English 355531 2011-08

Table of contents

Description 5

Package contents 5

Device specifications 5

Instructions for use 6

Connecting the multi-lead trialing cable to the 4-contact lead(s) 7
Connecting the multi-lead trialing cable to the 8-contact lead(s) 8
Preparing the multi-lead trialing cable for trial screening 10
Removing the multi-lead trialing cable after trial screening 10

Refer to the indications sheet 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, resterilization, and component disposal.

Refer to System Eligibility, Battery Longevity, Specifications reference
manual packaged with the software application card for neurostimulator
selection, battery longevity calculations and specific neurostimulator
specifications.

! USA

Refer to the clinical summary booklet packaged with the
neurostimulator for information on the clinical study results of the
neurostimulation system and individualization of treatment.

355531 2011-08 English 3

4 English 355531 2011-08

Description

The Medtronic Model 355531 Multi-lead Trialing Cable is part of a trialing and
intraoperative screening system for neurostimulation therapy.

Package contents

Multi-lead trialing cable

▪

Product literature

▪

Warranty card (USA only)

▪

w Warning: This device was designed for single patient use only. Do not

reuse, reprocess, or resterilize this product. Reuse, reprocessing, or
resterilization may compromise the structural integrity of the device and/
or create a risk of contamination of the device, which c ould result in patient
injury, illness, or death.

Device specifications

The multi-lead trialing cable has a lead housing with a lockable lid on the distal
end and a connector plug on the proximal end (Figure 1). The lead housing has
channels for up to four quadripolar (4-contact) leads and two octapolar (8­contact) leads. The connector plug inserts into an output jack on an external
neurostimulator (ENS).

Lid

Cable

Connector

plug

Lead housing

Slide lock

Figure 1. Lead housing, cable, and connector plug.

Table 1. Device specifications for the Multi-lead Trialing Cable Model 355531

Description Value

Capacity

Leads 4 quadripolar; 2 octapolar

Electrodes 32 electrodes, supporting 16 active
Weight 50 g (1.8 oz)
Width (housing and slide lock) 45 mm (1.8 in)
Length (housing) 57 mm (2.3 in)
Thickness (housing) 10 mm (0.4 in)
Volume (housing)

Lid Clear, with lid lift tab
Latch type

3

18 cm

Snap lid with slide lock

355531 2011-08 English 5

a

Table 1. Device specifications for the Multi-lead Trialing Cable Model 355531

Description

Length (housing, cable, and plug) 152 cm (60 in)
Storage temperature

a

All measurements are approximate.

(continued)

Value

–34° to +57°C (-30° to +135°F)

a

Table 2. Material of components in the Multi-lead Trialing Cable Model 355531

Component

Housing

Base Polycarbonate Yes
Lid Polycarbonate Yes
Slide lock Polycarbonate Yes
Hinge pin Stainless steel No
Contacts Gold- and nickel-

Cable

Conductor wires Copper No
Jacket Thermoplastic

Connector Thermoplastic

Connector contacts

package

Material Material

human tissue

plated beryllium
copper

elastomer (TPE)

elastomer (TPE)
Gold-plated bronze No

contacts

No

Yes

Yes

Instructions for use

Implanting physicians should be thoroughly familiar with all product labeling.

# Caution: To prevent possible uncomfortable or unexpected stimulation

(jolting or shocking sensation):

▪ program paramete r changes in small increments above the perception

threshold (the amplitude value(s) at which the patient first perceives
paresthesia).

▪ decrease the amplitude(s) to 0.0 V before:

– changing electrode polarities.
– connecting or disconnecting the cable to the external

neurostimulator.

– replacing the external neurostimulator batteries.
– turning on the neurostimulator.

Notes:

The procedure for connecting the multi-lead trialing cable is the same for

▪

leads and extensions.

Lead grooves that share a number are on an interconnected circuit

▪

(Figure 2b and Figure 4b).

If connecting a 4-contact lead, go to "Connecting the multi-lead trialing cable to
the 4-contact lead(s)" on page 7. If connecting an 8-contact lead, go to

6 English 355531 2011-08

"Connecting the multi-lead trialing cable to the 8-contact lead(s)" on
page 8.

Connecting the multi-lead trialing cable to the 4-contact lead(s)

# Caution: Before connecting components, wipe off any body fluids and dry

all connections. Fluids in the connection may result in intermittent
stimulation or loss of stimulation.

1. Wipe the lead contacts with sterile gauze. If necessary, use sterile (United
States Pharmacopeia [USP]) water or a nonionic antibiotic solution.

2. Move the slide lock to the unlocked position then push up on the lid lift tab
and down on the slide lock to open the multi-lead trialing cable
(Figure 2a).

3. Disconnect the long stylet handle from the 4-contact lead and withdraw
the long stylet from the 4-contact lead.

4. Insert the short stylet into the 4-contact lead and connect the short stylet
handle to the 4-contact lead.

5. Make sure the lead contacts and the electrical contacts inside the lead
grooves are dry and clean.

6. Align the short stylet and proximal end of the lead against the inside end
of a 4-contact lead groove of the connector (Figure 2a).

Lid lift tab

Short stylet

handle

7. Check that the lead contacts align with the electrical contacts inside the
lead groove and that the short stylet handle aligns with the stylet-shaped
portion of the lead groove.

Note: The lead and short stylet fit only one way into the multi-lead trialing
cable lead housing.

8. Press the lead and short stylet gently into the lead groove (Figure 2b). If
an additional 4-contact lead is used, repeat step 1 and steps 3 to 8.

9. Close the lid and move the slide lock into the locked position.
Note: Do not force the lid closed; it should close easily. If it does not,

disassemble the components and repeat steps 2 to 9.

10. Confirm correct seating by viewing the lead through the closed and locked
lid.

11. After connecting the multi-lead trialing cable to the patient’s implanted
lead, pass the connector plug out of the sterile field.

12. After verifying that the ENS is turned off, push the connector plug into the
output jack of the ENS (Figure 3).

a

Electrical
contacts

Figure 2. Multi-lead trialing cable with a 4-contact lead.

Lead groove

Lid latch

b

Lead groove
numbering

355531 2011-08 English 7

External neurostimulator

Output jack

Connector plug

Figure 3. Connecting the Multi-lead trialing cable to the ENS.

Note: Ensure that the arrow on the connector plug points toward the arrow
on the ENS and that the keyed slots of the connector plug and output jack
match.

w Warning: Maintain adequate slack in the cable. If there is not

enough slack and the cable is pulled, the percutaneous components
may be dislodged.

13. Refer to the appropria te programmer guide, ENS manual, and lead manual
to verify proper connection and identify optimal stimulation parameters.

Connecting the multi-lead trialing cable to the 8-contact lead(s)

# Caution: Before connecting components, wipe off any body fluids and dry

all connections. Fluids in the connection may result in intermittent
stimulation or loss of stimulation.

1. Wipe the lead contacts with sterile gauze. If necessary, use sterile (United
States Pharmacopeia [USP]) water or a nonionic antibiotic solution.

2. Move the slide lock to the unlocked position then push up on the lid lift tab
and down on the slide lock to open the multi-lead trialing cable
(Figure 4a).

3. Make sure the lead contacts and the electrical contacts inside the lead
grooves are dry and clean.

4. While holding the 8-contact lead, disconnect the stylet handle from the
lead (proximal end), and partially withdraw the stylet.

5. Align the proximal end of the lead against the inside end of an 8-contact
lead groove of the connector (Figure 4a).

8 English 355531 2011-08

Lid lift tab

ab

Lid latch

Retainer clips

Stylet

handle

6. Check that the lead contacts align with the electrical contacts inside the

7. Press the lead gently into the lead groove and the retainer clip

8. Close the lid and move the slide lock into the locked position.

9. Confirm correct seating by viewing the lead through the closed and locked

10. After connecting the multi-lead trialing cable to the patient’s implanted

11. After verifying that the ENS is turned off, push the connector plug into the

Electrical

contacts

Figure 4. Multi-lead trialing cable with an 8-contact lead.

lead groove.
Note: The lead fits only one way into the multi-lead trialing cable lead

housing.

(Figure 4b). I f an additional 8-contact lead is used, repeat step 1 and steps
3 to 7.

Note: Do not force the lid closed; it should close easily. If it does not,
disassemble the components and repeat steps 2 to 8.

lid.

lead, pass the connector plug out of the sterile field.

output jack of the ENS (Figure 5).

Lead groove

External neurostimulator

Output jack

Lead groove
numbering

Connector plug

Figure 5. Connecting the Multi-lead trialing cable to the ENS.

Note: Ensure that the arrow on the connector plug points toward t he arrow
on the ENS and that the keyed slots of the connector plug and output jack
match.

w Warning: Maintain adequate slack in the cable. If there is not

enough slack and the cable is pulled, the percutaneous com ponents
may be dislodged.

355531 2011-08 English 9

12. Refer to the appropria te programmer guide, ENS manual, and lead manual
to verify proper connection and identify optimal stimulation parameters.

Preparing the multi-lead trialing cable for trial screening

1. Place a gauze bandage on the skin where the lead and multi-lead trialing

cable will be placed on the patient.

2. Tape the lead and multi-lead trialing cable together to secure the
connection.

3. Tape the entire assembly to the patient’s skin, allowing for strain relief.

4. Proceed with the trial evaluation.

Removing the multi-lead trialing cable after trial screening

1. After verifying that the ENS is turned off, pull the connector plug from the

output jack of the ENS.

2. Remove all tape from the lead and multi-lead trialing cable.

3. Move the slide lock to the unlocked position then push up on the lid lift tab

and down on the slide lock to open the multi-lead trialing cable.

4. Gently lift the lead from the electrical contacts in the lead groove.

# Caution: Do not pull on the cable. Pulling on the cable may break a

wire or dislodge the lead. A broken wire or dislodged lead may result
in loss of stimulation and may require surgery to replace the lead.

5. Dispose of the multi-lead trialing cable according to environmental
regulations.

10 English 355531 2011-08

Contacts:

Asia:

Medtronic International Ltd.
Tel. [phone]
Fax [phone]

Medtronic Asia Ltd.
Tel. [phone]

Fax [phone]

Australia:

Medtronic Australasia Pty. Ltd.
97 Waterloo Road
North Ryde, NSW 2113
Australia
Tel. [phone]
Fax [phone]
Toll free 1-800-668-6700

Austria:

Medtronic Österreich GmbH
Tel. [phone]
Fax [phone]

Belgium:

Medtronic Belgium S.A.
Tel. [phone]
Fax [phone]

Canada:

Medtronic of Canada Ltd.
Tel. [phone]
Fax (1905)-826-6620

Czech Republic:

Medtronic Czechia s.r.o.
Tel. [phone]
Fax [phone]

Denmark:

Medtronic Danmark A/S
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Finland:

Medtronic Finland Oy/LTD
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France:

Medtronic France S.A.S.
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Medtronic GmbH
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Medtronic Russia
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Switzerland:

Medtronic (Schweiz) AG
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The Netherlands:

Medtronic B.V.
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U.K.:

Medtronic U.K. Ltd.
Tel. [phone]
Fax [phone]

USA:

Medtronic, Inc.
Tel. [phone]
Fax [phone]
Toll-free: (1-800)-328-0810

Manufacturer

Medtronic, Inc.
710 Medtronic Parkway
Minneapolis, MN 55432-5604
USA
www.medtronic.com
Tel. [phone]
Fax [phone]

REP

Authorized Representative
in the European Community

Medtronic B.V.
Earl Bakkenstraat 10
6422 PJ Heerlen
The Netherlands
Tel. [phone]
Fax [phone]

Europe/Africa/Middle East
Headquarters

Medtronic Europe Sàrl
Route du Molliau 31
Case Postale 84
CH-1131 Tolochenaz
Switzerland
www.medtronic.eu
Tel. [phone]
Fax [phone]

Asia-Pacific

Medtronic International Ltd.
Suite 1602 16/F, Manulife Plaza
The Lee Gardens, 33 Hysan Avenue
Causeway Bay
Hong Kong
Tel. [phone]
Fax [phone]

Contacts for specific countries are listed inside this cover.

EC

*M940920A004*

© Medtronic, Inc. 2011
All Rights Reserved

M940920A004