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St. Jude Medical 3046 Скачать руководство пользователя страница 16

Appendix B: Regulatory Statements

This section contains regulatory statements about your product.

Declaration of Conformity

Hereby, St. Jude Medical declares that this medical device is in compliance with the essential
requirements and other relevant provisions of AIMD directive 90/385/EEC. For a copy of the
declaration of conformity, please contact Technical Support.

Appendix C: Symbols and Definitions

The following symbols may be used in this document and on some of the products and
packaging:

Table 5. Symbols and definitions

Symbol

Definition

Caution, consult accompanying documents

Consult instructions for use

Follow instructions for use on this website

Magnetic Resonance (MR) Unsafe, an item poses unacceptable risks to the patient,

medical staff, or other persons within an MR environment

Single use only

Do not resterilize

Expiration date

Date of manufacture

Manufacturing facility

Temperature limits for storage conditions

Humidity limits

Pressure limits

Do not use if the product sterilization barrier or its packaging is compromised

Catalog number

12

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Содержание 3046

Страница 1: ...Percutaneous Trial Lead Kit Models 3046 3086 Clinician s Manual ...

Страница 2: ...ark of or licensed to St Jude Medical or one of its subsidiaries ST JUDE MEDICAL and the nine squares symbol are trademarks and service marks of St Jude Medical Inc and its related companies Pat http patents sjm com 2017 St Jude Medical Inc All Rights Reserved ...

Страница 3: ...ing Percutaneous Leads 4 Securing the Trial Lead 9 Disposing of Explanted Components 9 Technical Support 10 Appendix A Product Specifications 10 Storage Specifications 10 Product Materials 10 Compatibility Guidelines 10 Lead Specifications 11 Appendix B Regulatory Statements 12 Declaration of Conformity 12 Appendix C Symbols and Definitions 12 Additional Symbols for Product Labels 13 Appendix D CE...

Страница 4: ......

Страница 5: ... Energy from diathermy can be transferred through the implanted system and cause tissue damage at the location of the implanted electrodes resulting in severe injury or death Diathermy is further prohibited because it may also damage the neurostimulation system components This damage could result in loss of therapy requiring additional surgery for system implantation and replacement Injury or dama...

Страница 6: ... are implanted the leads should be routed to the IPG in adjacent tunnels Nonadjacent leads have the possibility of creating a conduit for stray electromagnetic energy that could cause unwanted stimulation in the patient Sterilization and Storage Single use device The implanted components of this neurostimulation system are intended for a single use only The components of this kit have been sterili...

Страница 7: ...ression or paralysis from placement of a lead in the epidural space Cerebrospinal fluid CSF leakage Paralysis weakness clumsiness numbness or pain below the level of the implant Persistent pain at the electrode site or IPG site Seroma mass or swelling at the implant site Allergic or rejection response to implant materials Product Description St Jude Medical leads are designed for spinal cord stimu...

Страница 8: ...vel to the predetermined location of the implanted IPG The appropriate vertebral level for needle entry should be identified and marked see the following figure to allow approximately 20 cm 8 in of the lead to lie in the epidural space This will facilitate stabilization of the lead and electrodes following implantation Typical entry levels for lead target sites include the following Figure 1 Sugge...

Страница 9: ...approach Figure 3 Insert needle at an angle of 30 or less 1 Spinal cord 2 Ligamentum flavum 3 Epidural space 4 Dural sac 3 Confirm entry into the epidural space using standard methods such as the loss of resistance technique see the following figure 5 ...

Страница 10: ...minimizes the risk of a dural tear Figure 5 Insert the guide wire 1 Slightly withdraw the stylet 2 Insert the guide wire 5 Once the tip of the guide wire is within the epidural space and slightly beyond the distal tip of the needle fully reinsert the stylet and advance the guide wire to the desired target see the following figure When advancing the guide wire it is very important to do so under fl...

Страница 11: ...If using the lead introducer optional remove the needle 1 Hold the guide wire 2 Remove the needle 7 If using the lead introducer optional insert the lead introducer over the proximal end of the guide wire at the same angle no more than 30 as the previously placed needle see the following figure Advance the lead introducer into the epidural space under fluoroscopy to the target position NOTE It may...

Страница 12: ...ucer optional remove the guide wire 1 Hold the lead introducer 2 Remove the guide wire 9 Insert the lead through the lumen of the needle or the lead introducer whichever is in place and advance the lead to the target site under fluoroscopic control see the following figure To aid placement percutaneous leads feature a removable stylet that provides added stiffness and facilitates control WARNING I...

Страница 13: ... guard against movement during the trial period For instructions about using the trial cable see the clinician s manual for that component 1 Once proper lead placement has been confirmed tape the trial lead securely to the skin with small adhesive strips 2 Connect the trial cable to the trial lead if disconnected 3 Loop the externalized lead and excess trial cable and secure it to the patient s ba...

Страница 14: ...ents according to the following conditions Table 1 Storage conditions for components Temperature 10 C 55 C 14 F 131 F Humidity 10 90 noncondensing Pressure 70 150 kPa 10 2 21 8 psi Product Materials Table 2 Product materials for percutaneous leads Component Material Electrodes and terminal end contacts Platinum iridium Insulation Polyurethane Compatibility Guidelines Percutaneous leads are compati...

Страница 15: ... to center spacing 7 mm 7 mm Array length 52 mm 24 mm Lead resistance 10 ohms 10 ohms Each kit listed in the previous table includes the following items 1 lead 1 guide wire for percutaneous leads Model 1102 1 anchor butterfly Model 1105 1 anchor long Model 1106 1 epidural needle 14 gauge 4 in Model 1114 NOTE A standalone accessory is available epidural needle 14 gauge 6 in Model 1116 1 stylet stra...

Страница 16: ...be used in this document and on some of the products and packaging Table 5 Symbols and definitions Symbol Definition Caution consult accompanying documents Consult instructions for use Follow instructions for use on this website Magnetic Resonance MR Unsafe an item poses unacceptable risks to the patient medical staff or other persons within an MR environment Single use only Do not resterilize Exp...

Страница 17: ...de Medical declares that this device is in compliance with the essential requirements and other relevant provisions of this directive Additional Symbols for Product Labels The following table shows additional symbols that may appear on the product labels for parts related to this kit Table 6 Additional symbols for product labels Symbol Definition Lead anchor butterfly Lead anchor long Epidural nee...

Страница 18: ... D CE Mark Date The following table lists the year in which the CE mark was awarded by model number Table 7 Year in which CE mark was awarded Model Year 1102 1105 1106 1114 1116 3046 3086 1999 1123 1124 2001 14 ...

Страница 19: ......

Страница 20: ...gium 32 2 774 68 11 Australian Sponsor St Jude Medical Australia Pty Limited 17 Orion Road Lane Cove NSW 2066 Australia Manufacturing Site St Jude Medical Puerto Rico LLC Lot A Interior 2 Rd Km 67 5 Santana Industrial Park Arecibo PR 00612 USA Manufacturing Site St Jude Medical Operations M Sdn Bhd Plot 102 Lebuhraya Kampung Jawa Bayan Lepas Industrial Zone 11900 Penang Malaysia sjm com 100154383 ...

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