Medtronic Intellis 97715 Rechargeable Neurostimulator Implant Manual
Description
The Medtronic Intellis Model 97715 Neurostimulator is part of a neurostimulation system for pain therapy.
Package Contents
- Neurostimulator
- Torque wrench
- Pocket sizer
- Bore plugs (2)
- Product literature
- Registration form
- Patient identification card
- Warranty card
Patient Identification Card
A patient identification card is packaged with this device. Advise the patient to carry the identification card at all times.
USA: The patient identification card packaged with the device is temporary; a permanent card will be mailed to the patient when Medtronic receives the registration form. The implant registration form registers the device warranties and creates a record of the device in Medtronic's implant data system.
Device Specifications
The neurostimulator is a multi-programmable, rechargeable device that delivers stimulation through 1 or more leads. The stimulation settings are stored in programs to target pain areas. A program is a specific combination of pulse width, rate, and intensity settings acting on a specific electrode combination (up to 16 electrodes per program). Up to 4 pain areas can be targeted by programs. When stimulating more than one pain area, the pulses are delivered sequentially—first a pulse from one program, then a pulse from the next program. Date, pulse width, intensity, cycling, and electrode polarity for each program within the group can have different values. Rate, rate limits, pulse width and intensity limits, and ramping for each program within the group have the same values.
Table 1. Operating Values for the Intellis Model 97715 Neurostimulator
| Programmable Parameter | Operating Values and Ranges |
|---|---|
| Number of defined groups | 1-3 (optional) |
| Number of programs per pain area | 1-3 |
| Number of programs | 12 |
| Number of pain areas | 1-4 |
| Electrode configuration | 2-16 electrodes as anode, cathode, or Off |
| Maximum intensity per electrode | 0-25.5 mA (0.1 mA increment) |
| Program intensity | 0-100 mA |
| Intensity – limits | Enabled or disabled at maximum of 25.5 mA per electrode |
| Pulse width | 60-1000 μs (10-μs increment) |
| Pulse width – limits | Enabled or disabled at maximum of 1000 Hz |
| Master rate | 10-1200 Hz (increment: 1 Hz from 10-30 Hz, 5 Hz from 30-250 Hz, 10 Hz from 250-500 Hz, 20 Hz from 500-1000 Hz, 50 Hz from 1000-1200 Hz) |
| Rate ratio | A fraction of the master rate (1/1, 1/2, 1/3, 1/4, 1/5) |
| Rate limits | Enabled or disabled (at maximum of 1200) |
| SoftStart/Stop | Off, On: 1, 2, 4, or 8 second ramp duration |
| Cycling | Off, On: 0.1 s-30 min (resolution: 0.1 s from 0.1-1 s, 1 s from 1 s-1 min, 1 min from 1-30 min) |
| AdaptiveStim | Off, On: 7 positions |
a Rate availability depends on how many pain areas are defined. For example, the maximum rate available in one defined pain area is 1200 Hz. The maximum rate available if two pain areas are defined is 600 Hz in each of those two pain areas.
b Pulse width limits are not available when AdaptiveStim is enabled.
c Cycling is not available for pain areas with AdaptiveStim enabled.
Table 2. Physical Characteristics of the Intellis Model 97715 Neurostimulator
| Description | Value |
|---|---|
| Connector type | Octapolar, in-line 2.8-mm (0.110-in) spacing |
| Height | 57.0 mm (2.1 in) |
| Width | 47.3 mm (1.9 in) |
| Thickness (case) | 6.3 mm (0.2 in) |
| Thickness (connector) | 8.9 mm (0.4 in) |
| Weight | 29.9 g (1.1 oz) |
| Volume | 13.7 cm³ |
| Battery life | 9 years before ERI |
| Power source | Lithium ion rechargeable battery |
| Storage temperature | -18 °C to +52 °C (0 °F to +126 °F) |
| Serial number model designator | NME |
| Radiopaque identification (ID) code | NME |
a All measurements are approximate.
b The serial number is the model designator followed by a number. The clinician programmer displays the entire serial number beginning with the model designator.
Table 3. Material of Components in the Intellis Model 97715 Package
| Components | Material | Material contacts human tissue |
|---|---|---|
| Neurostimulator Case | Titanium | Yes |
| Connector block | Titanium, polysulfone, silicone rubber, silicone medical adhesive | Yes |
| Grommets, seals | Silicone rubber | Yes |
| Setscrews | Titanium alloy | Yes |
| Adhesive | Silicone medical adhesive | Yes |
| Pocket sizer | Polypropylene | Yes |
| Bore plug | Silicone rubber; stainless steel | Yes |
| Torque wrench Handle | Polyetherimide | Yes |
| Torque wrench Shaft | Stainless steel | Yes |
Declaration of Conformity
Medtronic declares that this product is in conformity with the essential requirements of Directive 1999/5/EC on Radio and Telecommunications Terminal Equipment and Directive 90/385/EEC on Active Implantable Medical Devices.
For additional information, contact the appropriate Medtronic representative listed on the inside back cover of this manual.
Instructions for Use
Implanting physicians should be experienced in epidural-access procedures and should be thoroughly familiar with all product labeling.
Warning: DO NOT use the recharger on an unhealed wound. The recharging system is not sterile, and contact with the wound can cause an infection.
Caution: If the neurostimulator is not being used for an extended period of time, recommend that your patient charge the neurostimulator at least once per year. If the battery is discharged, stimulation will stop and the neurostimulator may not communicate with the controller.
Caution: Advise patients to charge the neurostimulator when a low battery message is displayed on the controller in order to maintain uninterrupted therapy from the neurostimulator. If the battery is discharged, stimulation will stop and the neurostimulator may not communicate with the controller.
Note: The patient will be able to use the controller and recharger to charge a discharged battery without causing damage to the battery or the neurostimulator.
Cautions:
- When using sharp instruments near the neurostimulator, be extremely careful to avoid nicking or damaging the case, the insulation, or the connector block. Damaging the neurostimulator may require surgical replacement.
- Do not use saline or other ionic fluids at connections, which could result in a short circuit.
Charging the Neurostimulator Battery
Check the battery level of the neurostimulator before opening the package, and recharge the neurostimulator if the battery is low. For charging instructions, refer to the recharging system user manual. If the patient will be sent home with stimulation on, charge the neurostimulator in the package before implant.
Verifying Neurostimulator Operation
Before opening the sterile neurostimulator package, verify that the neurostimulator is operable by using the clinician programmer to interrogate the neurostimulator and read the neurostimulator battery charge level. (Refer to the programming guide for instructions on how to read the battery charge level.)
Caution: Do not implant a neurostimulator if it was dropped onto a hard surface from a height of 30 cm (12 in) or more, because the neurostimulator may be damaged and fail to operate properly.
Note: The neurostimulator pocket may be flushed with an antibiotic solution; do not submerge the neurostimulator in fluid.
Connecting the Extension or Lead to the Neurostimulator
Caution: Before connecting components, wipe off any body fluids and dry all connections. Fluids in the connection may result in stimulation at the connection site, intermittent stimulation, or loss of stimulation.
- Wipe the extension or lead connector pins with sterile gauze. If necessary, use sterile (United States Pharmacopeia [USP]) water or a nonionic antibiotic solution.
- Make sure the connector block receptacles are dry and clean.
- Insert the appropriate extension or lead connector pins into the appropriate neurostimulator socket until they are seated fully within the connector block (Figure 1).
Notes:
- During insertion, some resistance is typical.
- To retract the setscrews, insert the torque wrench into the self-sealing grommet and rotate the setscrews counterclockwise; however, do not remove the setscrews from the connector block.
Caution: Do not insert the extension or lead connector into the connector block if the setscrews are not sufficiently retracted. If the setscrews are not retracted, the setscrews may damage the extension or lead and the extension or lead will not be seated fully into the connector block.
Figure 1. Insert the extension or lead connector pins fully into the neurostimulator. The diagram shows two sockets, Socket I (Electrodes 0-7) and Socket II (Electrodes 8-15), and two leads labeled Extension or Lead 1 and Extension or Lead 2.
Tightening Setscrews
Note: Insert a connector plug (from an accessory kit) into any unused neurostimulator socket.
4. For each extension, lead, or plug, fully insert the torque wrench (packaged with the rechargeable neurostimulation system) into each self-sealing grommet of the connector block and tighten each setscrew (Figure 2).
Cautions:
- Be sure the torque wrench is fully inserted into the self-sealing grommet. If the torque wrench is not fully inserted, the setscrew may be damaged, resulting in intermittent or loss of stimulation.
- Before tightening setscrews, ensure that the extension or lead connector pins are inserted into the connector block to prevent damaging the lead or extension.
- Verify that each leaf of the self-sealing grommet is closed after the torque wrench is withdrawn. If fluid leaks through a grommet seal that is not fully closed, the patient may experience shocking, burning, or irritation at the neurostimulator implant location, or intermittent stimulation, or loss of stimulation.
Figure 2. Tightening the setscrews in the self-sealing grommet. The diagram shows a close-up of the connector block with a torque wrench being inserted into a self-sealing grommet to tighten a setscrew.
Implanting the Neurostimulator
1. Place the neurostimulator into the subcutaneous pocket using the pocket sizer if desired and ensure that the extension or lead is not bent sharply. The neurostimulator can be implanted and charged with either side facing outward. For optimal recharging, place the neurostimulator within 1-2 cm (0.8 in.) of the skin surface.
Cautions:
Ensure that the neurostimulator is placed no deeper than 3 cm (1.2 in) below the skin and is parallel to the skin. If the neurostimulator is too deep or is not parallel to the skin, recharge may be inefficient or unsuccessful.
Do not coil excess extension in front of the neurostimulator. Wrap excess extension or leads around the perimeter (Figure 3) or behind the neurostimulator to help minimize potential damage during neurostimulator replacement surgery, help minimize potential kinking of the extension or lead, and minimize interference with telemetry and recharge operation.
Figure 3. Wrap excess extension around the perimeter of the neurostimulator. The diagram shows two views of the neurostimulator, one with excess extension coiled neatly around its perimeter, and another (crossed out) showing excess extension coiled in front.
2. Use the suture holes in the connector block to secure the neurostimulator to the muscle fascia with nonabsorbable silk.
Note: Secure the neurostimulator in the pocket to minimize movement or migration of the neurostimulator.
Checking System Integrity
The connections of the extensions and leads to the neurostimulator can be checked using the clinician programmer. Refer to the programming guide for detailed programming instructions.
Warning: To use the nonsterile programmer system components in a sterile field, place a sterile barrier between the patient and system components to prevent infection. Do not sterilize any components of the programmer system. Sterilization may damage the components.
- To ensure proper connection of each extension or lead to the neurostimulator, use the clinician programmer to perform the lead insertion check.
- If the lead insertion check results are not acceptable, refer to "Connecting the extension or lead to the neurostimulator".
Completing the Implant Procedure
- Close and dress all incisions.
- Turn off stimulation before sending your patient home.
- Ensure that a patient control device is given to the patient.
- Complete the device tracking and patient registration paperwork and return the documents to Medtronic.
Explanation of Symbols on Product or Package Labeling
Refer to the appropriate product for symbols that apply.
- CE 0123: Conformité Européenne (European Conformity). This symbol means that the device fully complies with AIMD Directive 90/385/EEC (NB 0123) and R&TTE Directive 1999/5/EC.
- ⚠️ Warning: Consult instructions for use
- Do not reuse
- Do not resterilize
- Date of manufacture
- Manufacturer
- Open here
- Use by
- SN: Serial number
- STERILE EO: Sterilized using ethylene oxide
- EC REP: Authorized Representative in the European Community
- ! USA: For USA audiences only
- Temperature limitation: (Symbol showing temperature range)
Trademarks
Medtronic® and SoftStart/Stop® are trademarks of Medtronic, Inc., registered in the U.S. and other countries.
AdaptiveStim™ and Intellis™ are trademarks of Medtronic, Inc.
Contact Information
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Manufacturer and Representatives
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