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Algostim Algovita 4300 Скачать руководство пользователя страница 7

Algovita Spinal Cord Stimulation System

Trial Stimulator Manual

3

Explanation of Symbols Used on Packaging and Trial

Stimulator

Symbol

Explanation

2014

Conformité Européenne (European Conformity). This symbol means that the device fully

complies with European Directive AIMD 90/385/EEC and R&TTE Directive 1999/5/EC

ONLY

Caution: Federal Law (USA) restricts this device to sale on or by the order of a physician

This device complies with Part 15 of the Federal Communication Commission rules

Authorized representative in Europe

Caution

Consult instructions for use

Serial number

Manufacturer

Date of manufacture

Catalogue number

Model

Temperature limit

Humidity limitation

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Содержание Algovita 4300

Страница 1: ...IFU Algovita SCS Trial Stimulator Manual for Clinicians 3 0 RESPONSIBILITY It is the responsibility of the product development engineer manufacturing engineer or labeling engineer to maintain this doc...

Страница 2: ...dges and free of significant rough edges or paper slivers 6 3 Color Color shall be uniform throughout each lot 6 4 Lot Quality Any lot of material which does not meet the requirements of this specific...

Страница 3: ...Algovita Spinal Cord Stimulation System Trial Stimulator Model 4300 External Pulse Generator EPG 2014 ONLY Trial Stimulator Manual for Clinicians...

Страница 4: ...Pocket Programmer Trial Stimulator FCC ID 2ABU84300 Pocket Programmer FCC ID 2ABU84100 These devices comply with part 15 of the FCC Rules Operation is subject to the following two con ditions 1 These...

Страница 5: ...he EPG On or Off 11 Quick Stimulation Off 12 Using the EPG During Intraoperative Test Stimulation 13 Connecting the Trial Cable to the EPG 13 Disconnecting the Trial Cable from the EPG 14 Stimulation...

Страница 6: ...EPG Service and Replacement 19 Disposal 19 Troubleshooting 20 Algostim Customer Service 21 Specifications 22 Electromagnetic Compatibility Declaration 24 Wireless Information 28...

Страница 7: ...complies with European Directive AIMD 90 385 EEC and R TTE Directive 1999 5 EC ONLY Caution Federal Law USA restricts this device to sale on or by the order of a physician This device complies with Pa...

Страница 8: ...ial Stimulator Symbol Explanation Fragile handle with care Keep dry Atmospheric pressure limitation Keep away from sunlight Do not use if package is damaged Non ionizing radiation Type BF equipment Ba...

Страница 9: ...ovita SCS System The EPG is used by the physician during intraoperative test stimulation and is used by the patient as part of the Algovita Trial Stimulation System The EPG allows the physician to pro...

Страница 10: ...on after electrocautery use Electromagnetic Interference Strong electromagnetic fields can potentially turn stimulation off or change the strength of stimulation which may cause an uncomfortable or jo...

Страница 11: ...ucing an Algovita SCS patient into an MRI scanner may result in severe patient injury death or device malfunction Modification Do not modify the EPG Modification of any SCS system component may result...

Страница 12: ...ammable or explosive environments eg an anesthetic mixture with air oxygen or nitrous oxide Using a battery powered device near flammable or explosive atmospheres can produce a spark which may cause i...

Страница 13: ...a negative reaction are persistent redness swelling or warmth at the area where the system is implanted A patient may have ongoing pain in the area where a lead or extension is located A patient may...

Страница 14: ...Off Turns stimulation off by pressing the button for 2 seconds Stimulation On Off Light Check if stimulation is on or off EPG Battery Status Light Check if the EPG is on and the battery charge level...

Страница 15: ...on stimulation is off Notes If the EPG Battery Status light flashes red replace the EPG batteries For instructions see Changing the EPG Batteries on page 16 Turn stimulation on using the Clinician Pro...

Страница 16: ...es a Quick Stimulation Off icon on stimulation screens and a Quick Stimulation Off button on the top of the Clinician Programmer If you are unable to turn stimulation off press the tabs on either side...

Страница 17: ...cable to the EPG 1 Check that stimulation is off Caution Connecting the trial cable to the EPG with stimulation on may cause an uncomfortable or jolting sensation 2 To prevent the lead from pulling ou...

Страница 18: ...turn the EPG off 2 While squeezing both tabs on the trial cable connector Figure 6 gently disconnect the cable from the EPG Caution Do not pull directly on the trial cable Pulling on the trial cable m...

Страница 19: ...e Cleaning the EPG After Use on page 18 Make sure the EPG has new batteries installed Make sure the EPG has been cleared of previously stored data See the Clinician Programming Manual for instructions...

Страница 20: ...to be used for several weeks remove the batteries Checking the Battery Charge Status The EPG has a flashing EPG Battery Status Light Figure 7 When the battery charge level is above 25 the light flash...

Страница 21: ...ries To change the EPG batteries Figure 8 1 Using a Phillips screwdriver loosen the screw on battery compartment cover 2 Remove the battery compartment cover and batteries 3 Insert the new batteries f...

Страница 22: ...waterproof Do not immerse the EPG in liquid or allow moisture to get inside the case If the EPG is dirty clean the outside with a slightly damp cloth Do not clean the EPG with bleach nail polish remo...

Страница 23: ...have the EPG serial numbers available The serial number is located on the back of the EPG Note The Limited Warranty does not cover loss or theft of the EPG or damage caused by misuse For additional in...

Страница 24: ...strength of the active program is too low Increase the strength of the active program The EPG is turned off Turn your EPG on Stimulation is off Although unlikely stimulation may have been turned off b...

Страница 25: ...ding this button down for 2 seconds turns stimulation off The EPG has malfunctioned Press the tabs on either side of the trial cable connector and disconnect the trial cable from the EPG Algostim Cust...

Страница 26: ...trode leads or three 8 electrode leads Amplitude upper patient limit 15 0 mA Amplitude lower patient limit 0 017 mA Pulse width 20 to 1500 s 20 s resolution Frequency upper patient limit 2000 Hz Frequ...

Страница 27: ...802 1 5mm touch proof connector and is analogous to using the hermetic enclosure of the IPG in stimulation Table 5 Storage and Operating Conditions for Trial Stimulator Model 4300 Parameter Value Oper...

Страница 28: ...t be used adjacent to or stacked with other equipment If adjacent or stacked use is necessary the EPG should be observed to verify normal operation in the configuration in which it will be used Table...

Страница 29: ...ical fast transient burst IEC 61000 4 4 2 kV for power supply lines 1 kV for input output lines Not applicable Not applicable Battery powered device Surge IEC 61000 4 5 1 kV line s to line s 2 kV line...

Страница 30: ...stance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occu...

Страница 31: ...mum output power of transmitter W Separation distance according to frequency of transmitter m 150 kHz to 80 MHz d 1 2 80 MHz to 800 MHz d 1 2 800 MHz to 2 5 GHz d 2 3 0 01 0 1 1 10 100 0 12 0 38 1 2 3...

Страница 32: ...not linked Note This equipment has been tested and found to comply with the limits for a Class B digital device pursuant to part 15 of the FCC Rules These limits are designed to provide reasonable pr...

Страница 33: ...Satellite or the Earth Exploration Satellite Services and must accept interference that may be caused by such stations including interference that may cause undesired operation This transmitter shall...

Страница 34: ...30 Trial Stimulator Manual Wireless Information...

Страница 35: ......

Страница 36: ...ights Reserved Part Number 0300 000026 06 1011440 001 Rev A 2014 05 Algostim LLC 10675 Naples St NE Blaine MN 55449 1 214 618 4980 Emergo Europe Molenstraat 15 2513 BH The Hague The Netherlands 31 0 7...

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