Boston Scientific Precision Connector M1 Manual

Precision™
Connector M1
Directions for Use
9055876-013
Content: MP9055876-013 REV A
Directions for Use
Mode d’emploi
Gebrauchsanweisung
Gebruiksaanwijzing
Instrucciones de uso
Istruzioni per l’uso
Instruções de Utilização
Οδηγίες χρήσης
Bruksanvisning
Brugsanvisning
Käyttöohje
Bruksanvisning
Návod k použití
Návod na použitie
Használati utasítások
Instrukcja obsługi
Указания за употреба
Upute za upotrebu
Instrucțiuni de utilizare
Navodila za uporabo
en fr de nl es it pt-EU el no da sv cs sk hu pl bg hr ro sl

9055876-013 ii of ii
en
Guarantees
Boston Scientic reserves the right to modify, without prior notice, information relating to its
products in order to improve their reliability or operating capacity.
Drawings are for illustration purposes only.
Trademark
All trademarks are the property of their respective holders.
Additional Information
For Indications and related information, see the Indications DFU. For contraindications,
warnings, precautions, adverse events summary, physician instructions, sterilization, storage
and handling, component disposal, and contact information for Boston Scientic, refer to the
Information for Prescribers DFU for your spinal cord stimulator system. For other device-
specic information not included in this manual, labeling symbols, and warranty information,
refer to the appropriate DFU for your SCS System as listed on your Reference Guide.
Boston Scientic recommends that implanting physicians read all product labeling prior to using
our devices.
Product Model Numbers
Model NuMber descriptioN
sc-9004-35
precisioN coNNetor M1 35 cM
sc-9004-55
precisioN coNNector M1 55 cM
sc-9004-70
precisioN coNNector M1 70 cM

Intended Use
9055876-013 1 of 159
en
Precision™ Connector M1
Intended Use
The Precision Connector M1 (PCM1) is designed to connect specic Medtronic Leads to the
Boston Scientic Implantable Pulse Generator (IPG). This Connector is intended to be used
when a Medtronic IPG is being replaced with a new Boston Scientic IPG.
Lead Compatibility
The PCM1 is compatible with the following Medtronic Lead models containing a quad in-line
proximal Connector (available prior to June 2007):
• 3487A/3888/3887 PISCES QUAD™
• 3890 PISCES Z-QUAD™
• 3587A RESUME™ II
• 3986A RESUME™ TL
• 3998/3999 SPECIFY™
Package Contents
(1) Precision Connector M1
(1) Hex Wrench

9055876-013 2 of 159
en
Directions for Use
1. Check the proximal end of the implanted Medtronic Lead to ensure that the Lead is clean
and not damaged.
2. On the PCM1, insert the Hex Wrench through the slit in the top of the Seal Plug to loosen
the Setscrew (Figure 1).
Figure 1: Precision Connector M1
Note:
• The Setscrew is tightened to the bottom of its housing during manufacturing and needs to
be loosened to insert a Lead. The Setscrew should only be loosened to an amount sufcient
to insert a Lead.
• There is no stop or feature to prevent excessive loosening or removal of the Setscrew.
Do not excessively loosen the Setscrew. Excessive loosening of the Setscrew may cause
damage to the Slit Seal Plug.
• The number of Hex Wrench insertions should be minimized to reduce the possibility of
damaging the Slit Seal Plug.
3. To loosen: turn the Setscrew counter clockwise.
4. To tighten: turn the Setscrew clockwise until the Hex Wrench clicks indicating lock.
5. When the Lead is securely attached to the PCM1, follow the appropriate tunneling and
pocketing procedures, and connect the proximal end of the PCM1 to the Boston Scientic
IPG.
NOTE: For the implantation procedure, see the appropriate DFU for your Boston Scientic
SCS System as listed in your Reference Guide.
Seal Plug
Setscrew

Directions for Use
9055876-013 3 of 159
en
Figure 2: Medical adhesive covering the Seal Plug
6. Prior to closing the wound, clean the top of the Seal Plug and use medical adhesive
(e.g. Dow Corning Silastic®Medical Adhesive Silicone, Type A - Sterile, as available
from Boston Scientic, part number SC-4320) to coat and seal the top of the Seal Plug
(Figure 2).
Note: Inadvertent damage to the Septum Seal may lead to unintended stimulation at the
Connector M1 if the medical adhesive is not used as intended.
7. When connecting to two Medtronic quad Leads or one Medtronic 2x4 paddle-style Lead,
two Precision Connector M1s are used. Each proximal end of the Medtronic Lead connects
to one PCM1 whic is inserted to one port of the IPG (Figure 3).
Figure 3: Two Precision Connector M1s connected to two Medtronic quad Leads or one Medtronic 2x4
paddle-style Lead
IPG
Medical Adhesive
Lead
PCM1

9055876-013 4 of 159
en
8. When connecting to one Medtronic quad Lead, one PCM1 is used. Connect the proximal
end of PCM1 to one port of the IPG. Plug the other port with the Port Plug supplied in the
IPG kit.
9. Programming: Since only the 4 distal Contacts are active, the Bionic Navigator™ software
will show the inactive contacts with an “X” on them, indicating that they are not connected.
By selecting the appropriate Lead type in the Bionic Navigator, it will use only the 4 active
contacts for programming.
10. To program Leads, refer to the Programming Manual or Bionic Naivgator Software Guide
provided for your Spinal Cord Stimulator System.
Specications and Technical Data
Precision Connector M1
Part Specications
Connector Lengths 35, 55, 70 cm
Connector Diameter 1.3 mm
Number of Electrode
Contacts
4
Contact Material Platinum/Iridium
Insulation Material Polyurethane,
Silicone
Conductor Material MP35N

Customer Service - USA
9055876-013 5 of 159
en
Customer Service - USA
In USA, to order replacement parts, or for answers to any questions you might have, please
contact the Customer Service Department:
• Phone: [phone],
[phone]
• Fax: [phone]
Boston Scientic Neuromodulation Corporation
25155 Rye Canyon Loop
Valencia, CA 91355, USA
Outside USA, if you have a specic question or issue, please contact your healthcare
professional.
Customer Service - Outside USA
If you have any other questions or need to contact Boston Scientic, choose your locality from
the contact list at the end of this document.

9055876-013 6 of 159
en
Argentina
T: [phone] F: [phone]
Australia / New Zealand
T: 1800 676 133 F: 1800 836 666
Austria
T: [phone] F: [phone]
Balkans
T: 0030 210 95 37 890 F: 0030 210 95 79 836
Belgium
T: 080094 494 F: 080093 343
Brazil
T: [phone] F: [phone]
Bulgaria
T: [phone] F: [phone]
Canada
T: [phone] F: [phone]
Chile
T: [phone] F: [phone]
China – Beijing
T: [phone] F: [phone]
China – Guangzhou
T: [phone] F: [phone]
China – Shanghai
T: [phone] F: [phone]
Colombia
T: [phone] F: [phone]
Czech Republic
T: [phone] F: [phone]
Denmark
T: 80 30 80 02 F: 80 30 80 05
Finland
T: 020 762 88 82 F: 020 762 88 83
France
T: + 33(0)1 39 30 97 00 F: + 33(0)1 39 30 97 99
Germany
T: 0800 072 3301 F: 0800 072 3319
Greece
T: [phone] F: [phone]
Hong Kong
T: [phone] F: [phone]
Hungary
T: [phone] F: [phone]
India – Bangalore
T: [phone]/5 F: [phone]
India – Chennai
T: [phone] F: [phone]
India – Delhi
T: [phone]/6 F: [phone]
India – Mumbai
T: [phone] F: [phone]
Italy
T: [phone] F: [phone]
Korea
T: [phone] F: [phone]
Malaysia
T: [phone] F: [phone]
Mexico
T: [phone] F: [phone]
Middle East / Gulf / North Africa
T: [phone] F: [phone]
The Netherlands
T:[phone] F: [phone]
Norway
T: 800 104 04 F: 800 101 90
Philippines
T: [phone] F: [phone]
Poland
T: [phone] F: [phone]
Portugal
T: [phone] F: [phone]
Singapore
T: [phone] F: [phone]
South Africa
T: [phone] F: [phone]
Spain
T [phone] F [phone]
Sweden
T: 020 65 25 30 F: 020 55 25 35
Switzerland
T: 0800 826 786 F: 0800 826 787
Taiwan
T: [phone] F: [phone]
Thailand
T: [phone] F: [phone]
Turkey – Istanbul
T: [phone] F: [phone]
United States
T: [phone] Toll Free: [phone]
F: [phone]
Uruguay
T: [phone] F: [phone]
UK & Eire
T: [phone] F: [phone]
Venezuela
T: [phone] F: [phone]
NOTE: Phone numbers and fax numbers may change.
For the most current contact information, please refer to
our website at http://www.bostonscientic-international.
com/ or write to the following address:
Boston Scientic Neuromodulation Corporation
25155 Rye Canyon Loop
Valencia, CA 91355 USA

9055876-013 7 of 159
en
This page intentionally left blank.

9055876-013 8 sur 159
fr
Garanties
Boston Scientic se réserve le droit de modier, sans préavis, les informations relatives à ses
produits dans le but d’améliorer leur abilité ou leur capacité de fonctionnement.
Les dessins et schémas sont présentés à des ns d'illustration uniquement.
Marques commerciales
Toutes les marques commerciales citées appartiennent à leurs détenteurs respectifs.
Informations supplémentaires
Pour connaître les indications et les informations connexes, consultez le mode d'emploi
Indications. Pour les contre-indications, les mises en garde, les précautions, les effets
indésirables, les instructions destinées aux médecins, la stérilisation, le stockage et la
manipulation, l'élimination des composants, et les coordonnées de Boston Scientic, reportez-
vous au mode d'emploi Informations destinées aux médecins de votre système de stimulation
médullaire (SM). Pour toute autre information spécique au dispositif non incluse dans ce
manuel, les symboles des étiquettes et les informations de garantie, consultez le mode
d'emploi approprié de votre système de SM indiqué dans votre Guide de référence.
Boston Scientic recommande à tous les médecins chargés de l'implantation de lire
attentivement les étiquettes produits avant d'utiliser nos dispositifs.
Références des produits
NuMéro de Modèle descriptioN
sc-9004-35
coNNecteur precisioN M1 35 cM
sc-9004-55
coNNecteur precisioN M1 55 cM
sc-9004-70
coNNecteur precisioN M1 70 cM