EXTERNAL NEUROSTIMULATOR
Contents
1. Health Extending Life Manufacturer Medtronic Inc 710 Medtronic Parkway Minneapolis MN 55432 5604 USA Internet www medtronic com Tel 1 763 505 5000 Fax 1 763 505 1000 Medtronic E C Authorized Representative Distributed by Medtronic B V Earl Bakkenstraat 10 6422 PJ Heerlen The Netherlands Tel 31 45 566 8000 Fax 31 45 566 8668 Europe Africa Middle East Headquarters Medtronic International Trading Sarl Route du Molliau 31 Case Postale CH 1131 Tolochenaz Switzerland Internet www medtronic co uk Tel 41 21 802 7000 Fax 41 21 802 7900 Asia Pacific Medtronic International Ltd Suite 1602 16 F Manulife Plaza The Lee Gardens 33 Hysan Avenue Causeway Bay Hong Kong Tel 852 2891 4068 Fax 852 2591 0313 Contacts for specific countries are listed inside this cover 001x M928467A All Rights Reserved M928467A001 Medtronic Inc 20072. Selection of parameters and values is limited by the clinician programmer with regards to appropriate applications therapies and devices Interlocks and out of regulation detection will prevent the use of some parameter combinations No more than 16 programs may be defined within the 8 groups Rate and rate upper limit for the ENS is limited to 500 Hz when two programs are active in a group 330 Hz when three programs are active in a group and to 250 Hz when four programs are active in a group Table 2 Physical characteristics of the Model 37022 external neurostimulator Description Value Length 89 mm 3 5 in Width 54 mm 2 1 in Thickness 28 mm 1 1 in 6 English 2007 9 Table 2 Physical characteristics of the Model 37022 external neurostimulator Description Value Weight with batteries 100 g 3 5 oz Output jack 21 pin Identification code NJS All measurements approximate Table 3 External neurostimulator electrical and operating characteristics Description Value Power source 2 AA alkaline batteries Battery life 144 hours minimum 21 days average for alkaline batteries Operating type Continuous Degree of protection against electrical Type BF shock Case material Polycarbonate ABS blend plastic resin Automatic shut off Moisture detected Battery door open Connector cable disconnected Connector open snap lid Battery life is based on 24 hour per day stimu
3. not use a pencil eraser or sandpaper Store the external neurostimulator at room temperature Avoid extreme hot or cold temperatures and direct sunlight The device is not waterproof Do not allow moisture to get inside the device Dispose of depleted batteries and worn out devices according to local requirements Safety and technical checks Periodic safety and technical checks or periodic maintenance of the external neurostimulator are not required The external neurostimulator contains no serviceable components If the external neurostimulator requires repair or is nonfunctional send it to the appropriate address USA Medtronic Inc Neurological Division MS N600 PO Box 1250 Minneapolis MN 55440 9087 Europe Africa Middle East and Asia Pacific countries Medtronic EOC Medical Equipment Service Europe Earl Bakkenstraat 10 6422 PJ Heerlen The Netherlands Tel 31 455664880 Fax 31 455668028 2007 9 English 11 12 English 2007 9 Contacts Asia Medtronic International Ltd Tel 02891 4068 Fax 2591 0313 Medtronic Asia Ltd Tel 02 548 1148 Fax 02 518 4786 Australia Medtronic Australasia Pty Ltd Tel 02 9879 5999 Fax 02 9879 5100 Austria Medtronic Osterreich GmbH Tel 01 24044 Fax 01 24044 100 Belgium Medtronic Belgium S A Tel 02 456 0900 Fax 02 460 2667 Canada Medtronic of Canada Ltd Tel 1905 826 6020 Fax 1905 826 6620 Czech Republic Medtronic Czechia s r o Tel
4. 2 965 795 80 Fax 2 965 795 89 Denmark Medtronic Danmark A S Tel 45 32 48 18 00 Fax 45 32 48 18 01 Finland Medtronic Finland OY LTD Tel 09 755 2500 Fax 09 755 25018 France Medtronic France S A S Tel 01 5538 1700 Fax 01 5538 1800 Germany Medtronic GmbH Tel 0211 52930 Fax 0211 5293100 Greece Medtronic Hellas S A Tel 02 10 677 90 99 Fax 02 10 677 93 99 Hungary Medtronic Hungaria Kft Tel 1 889 06 00 Fax 1 889 06 99 Ireland Medtronic Ireland Ltd Tel 01 890 6522 Fax 01 890 7220 Italy Medtronic Italia SpA Tel 02 241371 Fax 02 241381 Tel 06 328141 Fax 06 3215812 Japan Medtronic Japan Tel 3 6430 2001 Fax 3 6430 7140 Latin America Medtronic Inc Tel 1305 500 9328 Fax 1786 709 4244 The Netherlands Medtronic B V Tel 045 566 8000 Fax 045 566 8668 Norway Medtronic Vingmed AS Tel 67 58 06 80 Fax 67 10 12 12 Poland Medtronic Poland Sp z 0 0 Tel 022 465 69 00 Fax 022 465 69 17 Portugal Medtronic Portugal Lda Tel 21 724 5100 Fax 21 724 5199 Spain Medtronic Ib rica S A Tel 91 625 0400 Fax 91 650 7410 Sweden Medtronic AB Tel 08 568 585 00 Fax 08 568 585 01 Switzerland Medtronic Schweiz AG Tel 021 803 8000 Fax 021 803 8099 U K Medtronic U K Ltd Tel 01923 212213 Fax 01923 241004 USA Medtronic Inc Tel 1 763 505 5000 Toll free 1 800 328 0810 Fax 1 763 505 1000 Medtronic Alleviating Pain Restoring
5. ay Medtronic EXTERNAL 37022 NEUROSTIMULATOR User manual USA SS Rx onl Explanation of symbols on product or package labeling Refer to the appropriate product for symbols that apply Sg SS Conformit Europ enne European Conformity This symbol means that the device fully complies with MDD 93 42 0123 and Directive 1999 5 EC The use of this device might be subject to individual country licensing regimes in Europe System meets the applicable Canadian 22 2 601 1 90 R2001 electrical safety standard requirements Caution consult accompanying documents Serial number 60601 1 60601 1 Type BF equipment Non ionizing electromagnetic radiation Storage temperature Relative humidity Atmospheric pressure For USA audiences only Do not dispose of this product in the unsorted municipal waste stream Dispose of this product according to local regulations See http recycling medtronic com for instructions on proper disposal of this product Chinese Standard SJ T11364 2006 Logo Electronic Information Products Pollution Control Symbol The date in this logo means the environmental protection use period of the product 2007 9 English 1 Medtronic is registered trademark of Medtronic Inc USA FCC Information The following is communications regulation information on the Model 37021 External Neuro
6. fferent values Rate rate limits SoftStart Stop value and cycling for each program within a group have the same values Battery compartment Therapy stop cover key Output jack Figure 1 Model 37022 external neurostimulator 2007 9 English 5 Table 1 Operating values for the Model 37022 external neurostimulator Programmable parameter Operating range and resolution Number of defined groups 1 to 8 Number of programs per 1 to 4 group Electrode configuration 2 to 16 electrodes as anode cathode or OFF Amplitude 0 to 10 5 V with 0 05 V or 0 1 V resolution 0 to 25 5 mA with 0 1 mA resolution Amplitude upper patient Programmed value to 10 5 V same resolution as amplitude imit Programmed value to 25 5 mA same resolution as amplitude Amplitude lower patient V to the programmed value same resolution as amplitude imit 0 mA to the programmed value same resolution as amplitude Pulse width 60 to 1000 us 10 us resolution Pulse width upper patient Programmed value to 1000 us 10 us resolution imit Pulse width lower patient 60 us to the programmed value 10 us resolution imit Rate 2 to 1000 Hz Rate upper patient limit Programmed value to 1000 Hz same resolution as rate Rate lower patient limit 2 to the programmed value SoftStart Stop OFF ON 1 2 4 or 8 second ramp duration Cycling OFF ON 0 1 s to 24 hrs Scheduled therapy OFF ON 1 to 8 events per 24 h period v
7. l 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 gt Matching the keyed slots of the cable plug and the output jack push the plug end of the connector cable fully into the output jack on the external neurostimulator Using the THERAPY STOP key The red THERAPY STOP key can be used when you need to immediately turn OFF the external neurostimulator You must use either the patient or clinician programmer to turn the external neurostimulator ON again The THERAPY STOP key is not an ON OFF control gt Press the red THERAPY STOP key Disconnecting the connector cable from the external neurostimulator 1 Using the clinician programmer or patient programmer turn the external neurostimulator OFF 10 English 2007 9 2 Disconnect the connector cable from the external neurostimulator Device care and storage Keep new batteries available Use the patient programmer daily to check the external neurostimulator batteries Replace low or depleted batteries Handle the device with care Do not drop strike or step on the device Do not dismantle or tamper with the device Clean the outside of the device with a damp cloth when necessary Mild household cleaners will not damage the device or labels The battery contacts be cleaned periodically with a cotton swab dampened with alcohol Do
8. lation using 1 group containing 3 active programs For all programs impedance 500 Q Amp 4 0 V PW 330 us Rate 70 Hz Cycling off gt Use the clinician programmer or patient programmer to turn the external neurostimulator ON once the condition is resolved 2007 9 English 7 Table 4 External neurostimulator storage and operating conditions Parameter Storage Operating Minimum temperature 40 C 40 F 10 C 50 F Maximum temperature 65 C 149 F 44 C 111 F Maximum humidity 95 non condensing 75 non condensing Minimum atmospheric 70 kPa 70 kPa pressure Maximum atmospheric 106 kPa 106 kPa pressure 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 93 42 EEC on Medical Devices For additional information contact the appropriate Medtronic representative listed on the inside back cover of this manual 8 English 2007 9 Instructions for use The external neurostimulator is used to evaluate lead placement and stimulation settings A Caution The device is not certified for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide The consequences of using the device near flammable atmospheres are unknown Replacing the external neurostimulator batteries Replace the external neurostimulator batteries before each te
9. mulator 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 2007 9 English 3 4 English 2007 9 Purpose of the device The Medtronic Model 37022 External Neurostimulator is used to evaluate a Medtronic Neurostimulation System during lead placement or test stimulation The external neurostimulator and the implantable neurostimulator produce comparable symptom suppression when set to the same parameter settings Device description The Medtronic Model 37022 External Neurostimulator is part of a neurostimulation system Package contents External neurostimulator External neurostimulator holder 2 AA alkaline batteries Product literature Warranty card USA only Device specifications The external neurostimulator Figure 1 is a programmable device that delivers stimulation through one or more leads The stimulation settings are stored in programs A program is specific combination of pulse width rate and amplitude settings acting on a specific electrode combination Up to four programs can be combined into a group When using more than one program the pulses are delivered sequentially first a pulse from one program then a pulse from the next program Pulse width amplitude and electrode polarity for each program within a group can have di
10. st stimulation and when the batteries are low or depleted The battery level is shown on the clinician programmer screen A Cautions When replacing batteries during test stimulation insert the new batteries within 15 minutes of removing the old batteries If the batteries are not replaced within 15 minutes the neurostimulator may reset When a neurostimulator resets stimulation history is no longer available and the stimulation settings may not reflect recent programming changes Do not leave depleted batteries in the external neurostimulator The batteries corrode and cause damage to the electronic components If the device will not be used for several weeks remove the batteries from the device A battery left in the device may corrode causing damage to the electronic components 1 Ifthe external neurostimulator is ON use the clinician programmer or patient programmer to turn the neurostimulator OFF 2 If the connector cable is attached to the external neurostimulator disconnect the cable 3 If the neurostimulator is in the external neurostimulator holder remove the neurostimulator from the holder 4 Press down lightly on the battery compartment cover push the cover in the direction of the arrow then swing the cover open 5 Insert 2 new AA alkaline batteries Correct battery polarity is indicated on the battery compartment cover 6 Replace the battery compartment cover then slide the cover in the opposite direction of
11. stimulator FCC ID LF537021 This device complies with Part 15 of the FCC Rules Operation is subject to the following two conditions 1 this device may not cause harmful interference and 2 this device must accept any interference received including interference that may cause undesired operation IMPORTANT Changes or modifications to this product not authorized by Medtronic Inc could void the FCC Certification and negate your authority to operate this product 2 English 2007 9 Table of contents Purpose of the device 5 Device description 5 Package contents 5 Device specifications 5 Declaration of Conformity 8 Instructions for use 9 Replacing the external neurostimulator batteries 9 Attaching the external neurostimulator and connector cable to the clinician programmer 10 Using the external neurostimulator during test stimulation 10 Device care and storage 11 Safety and technical checks 11 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 neurosti
12. the arrow until it snaps into place 7 Reconnect the cable For detailed instructions see page 10 Notes After the batteries are installed and the battery compartment cover is closed the neurostimulator may take up to 60 seconds for device initiation Stimulation is not available until device initiation is complete Dispose of depleted batteries and worn out devices according to local requirements 2007 9 English 9 Attaching the external neurostimulator and connector cable to the clinician programmer The external neurostimulator is usually attached to the clinician programmer during lead placement 1 Locate the programming head on the back of the clinician programmer 2 Place the external neurostimulator so it fits into the slot on the programming head 3 Turn the neurostimulator so the output jack is positioned as displayed in Figure 2 Note Facing the output jack away from the clinician programmer properly aligns the two devices for communication and prevents the cable from resting on the programmer Output jack Figure 2 External neurostimulator attached to the clinician programmer Using the external neurostimulator during test stimulation When programming during test stimulation hold the clinician programmer programming head over the external neurostimulator The neurostimulator does not need to be attached to the programmer Connecting the connector cable to the external neurostimulator A Caution Do not pul
Download Pdf Manuals
Related Search