Algostim Algovita 4300 User Manual Download Page 4 | Manualshive

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Algostim Algovita 4300 User Manual Download Page 4

Refer to the Information for Prescribers Manual for indications, contraindications, warnings, pre-

cautions, adverse events, clinical study results, and related information.

Algovita™ is a trademark of QIG Group, LLC

FCC Information (US Only)

The following is communications regulation information about the Algovita Trial Stimulator and

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 devices may not cause harmful interference, and (2) These devices must accept

any interference received including interference that may cause undesired operation.

Important: Changes and modifications to the products not authorized by Algostim, LLC could void

the FCC certification and negate your authority to operate these products.

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Summary of Contents for Algovita 4300

Page 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...

Page 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...

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

Page 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...

Page 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...

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

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

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

Page 35: ......

Page 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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