Theragen ActaStim-S Instructions For Use Manual Download Page 21 | Manualshive

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TECHNICAL & WARRANTY

Emissions Test

RF Emissions

Harmonic Emissions

Voltage Fluctuations /
Flicker Emissions

Immunity Test

Electrostatic Discharge
(ESD)

Electrical Fast Transient /
Burst

Surge

Voltage Dips and
Interruptions

Standard

CISPR 11

.ȁǼǻǻǻɫǾɫǽ

.ȁǼǻǻǻɫǾɫǾ

Standard

.ȁǼǻǻǻɫǿɫǽ

.ȁǼǻǻǻɫǿɫǿ

.ȁǼǻǻǻɫǿɫȀ

.ȁǼǻǻǻɫǿɫǼǼ

Test Levels

ʏɑɫȃºrËÄææ
ʏɑɫǼȀºr¬Ú

ʙǽºr
Ǽǻǻº+āÚ×æ¬æ¬ËÄ£ÚÙêÄü

ʙǽºr

.ȁǼǻǻǻɫǿɫȃ

Power Frequency
H-Field

ǾǻɑÃ

rË½æ¤¬×ÞɅ

Ǽɚ ǻʥgcɐǻɋȀü½æǻʷɆ

ǿȀʷɆȄǻʷɆǼǾȀʷɆǼȃǻʷɆ
ǽǽȀʷɆǽȂǻʷÄǾǼȀʷ

ǽɚ ǻʥgcɐǼü½

and

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]¬Ä¤½×©ÞɅæǻʷ

rË½æ¤¬ÄæÚÚê×æ¬ËÄÞɅǻʥgcɐ
ǽȀǻɑǾǻǻü½

Compliance

Group 1, Class B

Class A

Yes

ǽǻ

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Summary of Contents for ActaStim-S

Page 1: ...ActaStim S Spine Fusion Stimulator INSTRUCTIONS FOR USE ...

Page 2: ...ling normal again Is what I m feeling right now normal How much activity is enough and how much is too much Your doctor is the best person to answer those questions but ActaStim S will help by giving your Doctor a very special insight into your day to day recovery through the proprietary ActaStim Sync app that you will be using in conjunction with your ActaStim S device The ActaStim S device is de...

Page 3: ...on You are able to track your pain õ ÞɆ Ã º ÄËæ Ë Þ Ĉ õ Ã ÄæÞɆ Ä ÞüÄ æ õ æü Ä êÞ æ from your ActaStim S device You will be able to produce a report that you can share with your Doctor before at and between your appointments to help them fully understand how you are progressing day to day This extra insight will place them in a better position to answer any questions that you have On behalf of the ...

Page 4: ...re Battery Replace Battery Error End of Life Smart Phone Connection Mute Button Battery Charging Compliance and Activity Monitoring Electrode Care and Replacement Cleaning Instructions Patient Counseling Information Storage and Handling Disposal Instructions Clinical Information Technical Information Electromagnetic Compatibility Symbol Descriptions Warranty and Customer Care Information 4 5 6 6 6...

Page 5: ...ry Charging Cable Power Supply Block ææ Úü Ú Ú əö æ ɚ öɑ ûæÚ Battery Battery Charger Dock æÚË Ëö Ú Ëõ ÚÞ əXê Äæ æü ǽǻɆ disconnect electrode lead wires from Generator Cable before showering Travel Case Xê º æ Úæ ê əÄËæ Þ ËöÄɚ ÄÞæÚê æ ËÄÞ ËÚ gÞ əÄËæ Þ ËöÄɚ ǽ 3 ǿ 5 6 11 Ǽǽ 1b 1a 9 Ǽǻ 8 7 ǽ 8 5 1a 1b ǿ 3 7 Ǽǻ ǽ 6 9 INFORMATION SAFETY ǿ ...

Page 6: ...has been dropped or immersed into water Do not short circuit crush penetrate or otherwise damage the battery or connect conductive materials across the battery terminals These and other abuses can lead to serious injury or burns æ Ä Ú æËÚ Þ ÄËæ Ä êÞ Ɇ Ú ÃËõ æ ææ Úüɋ c Þ ö õË Ä æËÚÞ əõ Þê Ɇ sound and vibration from activating Do not expose the system to prolonged heat sunlight or cold Normal operat...

Page 7: ...ActaStim S and a pacemaker or cardioverter must be assessed on an individual basis such as with an electrocardiogram prior to use The patient should be referred to a cardiologist for monitoring of pacemaker function while wearing the active stimulator device If there are any observable adverse changes in the pacemaker rhythm or output ActaStim S should not be used c Þ æü Ä ą æ õ Ä ÞÞ Ë æ æ Ãɫ Ä Ú ...

Page 8: ...ories may not be compatible and may damage ActaStim S If any component does not function properly contact Customer Support at 1 800 901 5667 No attempt should be made to modify or repair ActaStim S Patients should be able to use ActaStim S in accordance with the instructions for use If a patient cannot comply with these instructions for any reason use of ActaStim S is not recommended Adverse Event...

Page 9: ...equired for the proper function of ActaStim S c ÞüÞæ Ã Þ Ä Þ Ä æË õ ǽǿ ËêÚÞ Ë æÚ æÃ Äæ ÚËÃ ê ü Ú ææ Úü Ä ÚËêæ Ä Ú Ä Ä Þö Ä Ë æ ǽ ææ Ú Þ õ Úü ǽǿ ËêÚÞ ö ÄÞêÚ ÄË inadvertent gaps in treatment Indicators are provided to demonstrate the latest point at which a fully discharged battery will need recharging if treatment is to avoid being interrupted Examine the skin for signs of irritation when replacing...

Page 10: ...the right of the area of the spinal fusion so that the electrodes are on the back four to six inches apart Depending on the ability to move after surgery it may be helpful to ask another person to assist in placing these electrodes The patient should consult their prescribing physician if they have any questions or concerns regarding proper electrode placement If the skin becomes abnormally red at...

Page 11: ...ǽ ÄÞ Ë æ æÚË ö Ú Þɋ Note This may be done before connecting the electrodes to the back if that is easier to manage To remove the belt clip pull the bottom of the curved end approximately away from the generator so that the clip can be pushed upwards until clear of the generator If it is desired to attach the generator to a belt waistband or pocket Ë æ æ æ Ä Þ æ ĉ æ Þ Ë æ ÄæË æ generator until the ...

Page 12: ...lfunction Indicator Mute Button c ææ Úü õ Ɇ ÚÚËÚɑC êÄ æ ËÄ Ä Ú ê æ Ä ËÃ æ Ä æËÚÞ ÞË õ Ä accompanying vibration and audible buzzer in case the icons are not visible DIRECTIONS FOR USE Insert a battery The battery can only be properly inserted in one orientation and incorrect insertion will be obvious leaving a gap between the bottom of the battery pack and the generator Check æ æ æ Ú Þ ÄËê Ú æË Þæ ...

Page 13: ...Ä æ Ä Ú æËÚ ö Ú ËÄÄ æ ËÄ Ë º Ä ɑËÚ æ Ä Ú æËÚ ö Ú block and the generator Check all connections to ensure they are complete If all connections are complete then the circuit will be detecting that the resistance ÚËõ ü æ æÚË Ä ɑËÚ æ ÄæɸÞ Ë ü Þ ËêæÞ Ë æ æ Ãɫ Ë Ú æ Ä Ú Ä ɋ æ Þ ÃËÞæ º ü æ æ æ Þ Ëê Ú Þê æ ÚËÃɅ The electrodes being too dry Moisten them by applying a small amount of water onto the skin fac...

Page 14: ...ime to avoid any chance of disruption to treatment but at the least should be Ú Ú ËÄ æ ËÚ Ä ææ Úü õ Ä æËÚ ĈÚÞæ ËÃ Þ ËÄɋ Error æ ÚÚËÚɑÃ êÄ æ ËÄ ËÄ êÃ Ä æ Þ əËÚ Ä ɚ Ú ÃËõ æ battery and replace it If the problem persists contact Customer Support at 1 800 901 5667 End of Life æ Ú ǽȂǻ üÞ Ë êÞ æ æ Ãɫ ö ÞæË Ë Ú æ Ä Ä æ Þ ö Ä æ ü æ ææ Úü õ Ɇ ÚÚËÚɑÃ êÄ æ ËÄ Ä Ú ê æ Ä ËÃ æ ËÄÞ ĉ Þ Ä ËÚ Ä ɋ Y ÃËõ æ ææ Úü Ä r...

Page 15: ... power supply block If the dock is to be used insert the charger into the dock ensuring it is fully inserted and connect the charging cable to the dock socket and wall socket plug Plug in the wall socket plug Ú æ ææ Úü æ ÚËËÃ æ Ã Ú æêÚ əǽǿʷ əȂȀʷ ɚɚɋ Ú Ä may require up to 3 hours Charging time may vary in warmer or colder temperatures Remove the battery to be charged from the generator or if it has...

Page 16: ...ê æËËæ ËÄÄ æ ËÄ ËÄ êÃ Ä æ Ä ə ê ɚ æ Ú Äº Ä ê ö Þæ æÚü Ä æË ËÄÄ æɋ Y Ú æË æ Xê º æ Úæ ê Ä Ë Ëö æ ÚËÃ æÞ ö æ Ä æ ActaStim Sync app to complete connecting and extract compliance and activity data Electrode Care and Replacement If removing the electrode temporarily for any reason replace the plastic backing material to protect them Before replacing them on the back check to see that the surface is sti...

Page 17: ...a lithium ion rechargeable battery Skin Irritation Examine the skin for irritation when replacing the electrodes If irritation is present relocate the electrodes adjacent to the original sites The patient should be evaluated periodically to assess the skin for sensitivity Bathing Disconnect ActaStim S during bathing showering or swimming It should be reconnected as soon as practical following thes...

Page 18: ...æÞ ÄÚË Ä æ Ä Þæê ü Ä ö Ë êÞ æ õ æ Þæ ËÄ Ɇ Ä Ä û Ú Ä Þº Ä ÚÚ æ æ ËÄ Ä æ æ Þ Þ Ú ÞËÄ æË ö æ Ú ö ÚËÃ æ Þæê ü əǽɋȁʥɚɋ J æ Þ Ä Ä Þê æÞɆ ËêÚ ö Ú Ä æ æ õ ÚËê Ä Ĉõ ö Ú Ä æ Ë ÚËê ɋ c Ú Ëæ Ú Þê æÞ ö æ Ú ö ÚËÃ æ Þæê ü êÞ Ë õ ÚÞ õ ÄæÞɅ ËÄ Ë öËêÄ Ä æ ËÄ əÄËÄɫ õ Ú æ ɚɐ ËÄ Ë º Þ ÞÃÞɐ Ä Ɇ ËÄ æ õ ö Þ not progressing æ Þê æÞ ö Ë ËÃ æ æ Þæê ü û Ú Ä õ ÚÞ õ ÄæÞɅ əǼɚ Ä ə Ëɚɐ əǽɚ Ú êÚÚ Äæ Ä ê æË Ëõ Úɫ æ õ æü ə Ëɚɐ əǾɚ Ë...

Page 19: ...sure tilted up to 15 CË Ë Ë Ú æ ËÄɅ ËÄæ ÄêËêÞ Output Waveform ȁǻ ā ə êÞ ËÚ Ã ÄêÞ Ǽǻʥɚ Þ ÄêÞË Ȁ æË Ǽǻ Ã əÚɋÃɋÞɋɚ æ Ã Ä Þ æö Ä Ǽǻǻ Ä ǿȀǻ J ÃÞ Ú æ Ú æ Ä ǾÃ əÚɋÃɋÞɋɚ æ Ã Ä Þ æö Ä ǿȀǻ J ÃÞ Ä ȂȀǻ J ÃÞ 18 Transport and Storage Conditions ɫǽȀʷ æË ʏȀʷ 5 C to 35 C at a relative humidity ê æË ȄǻʥɆ ÄËÄɫ ËÄ ÄÞ Ä ɐ ʕ ǾȀʷ æË Ȃǻʷ æ ö æ Ú õ ËÚ Ú ÞÞêÚ ê æË Ȁǻ V Operating Conditions ʏȀʷ æË ʏǿǻʷ ǼȀ æË Ȅǻʥ êÃ æü Ȃǻǻ æ...

Page 20: ...his equipment and the other equipment should be observed to verify that they are operating normally WARNING gÞ Ë ÞÞËÚ Þ Ä Þ Ëæ Ú æ Ä æ ËÞ Þ Ĉ ËÚ ÚËõ ü Theragen of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation Do not use unapproved components Only use system components provided with the sys...

Page 21: ...ruptions Standard CISPR 11 ȁǼǻǻǻɫǾɫǽ ȁǼǻǻǻɫǾɫǾ Standard ȁǼǻǻǻɫǿɫǽ ȁǼǻǻǻɫǿɫǿ ȁǼǻǻǻɫǿɫȀ ȁǼǻǻǻɫǿɫǼǼ Test Levels ʏɑɫ ȃ ºr ËÄæ æ ʏɑɫ ǼȀºr Ú ʙ ǽ ºr Ǽǻǻ º ā Ú æ æ ËÄ Ú Ùê Ä ü ʙ ǽ ºr ȁǼǻǻǻɫǿɫȃ Power Frequency H Field Ǿǻ ɑÃ rË æ ÞɅ Ǽɚ ǻ ʥ gcɐ ǻɋȀ ü æ ǻʷɆ ǿȀʷɆ ȄǻʷɆ ǼǾȀʷɆ ǼȃǻʷɆ ǽǽȀʷɆ ǽȂǻʷ Ä ǾǼȀʷ ǽɚ ǻ ʥ gcɐ Ǽ ü and Ȃǻ ʥ gcɐ ǽȀɑǾǻ Ä Þ Ʌ æ ǻʷ rË æ Äæ ÚÚê æ ËÄÞɅ ǻ ʥ gcɐ ǽȀǻɑǾǻǻ ü Compliance Group 1 Class B Class...

Page 22: ...385 MHz Pulse Modulation 18 Hz ǽȃ rɑÃ ǿȀǻ C ā C ʏɑɫȀ º ā õ æ ËÄ Ǽ º ā sine Ȅ rɑÃ ȂǼǻɑȂǿȀɑȂȃǻ C ā Vê Þ CË ê æ ËÄ ǽǼȂ ā ǽȃ rɑÃ ȃǼǻɑȃȂǻɑȄǾǻ C ā Pulse Modulation 18 Hz ȁǼǻǻǻɫǿɫȁ Conducted RF 3 V ǻɋǼȀ C ā ɪ ȃǻ C ā 6 V in ISM and amateur radio bands between ǻɋǼȀ C ā Ä ȃǻ C ā ȃǻ ʥ C æ Ǽ º ā ǽǼ ...

Page 23: ...TECHNICAL WARRANTY Radiated RF cont ǽȃ rɑÃ ǼɆȂǽǻɑǼɆȃǿȀɑǼɆȄȂǻ C ā Vê Þ CË ê æ ËÄ ǽǼȂ ā ǽȃ rɑÃ ǽɆǿȀǻ C ā Vê Þ CË ê æ ËÄ ǽǼȂ ā Ȅ rɑÃ ȀɆǽǿǻɑȀɆȀǻǻɑȀɆȂȃȀ C ā Vê Þ CË ê æ ËÄ ǽǼȂ ā ǽǽ ...

Page 24: ...ogue or part number Pressure range Temperature limit Recycle electronic equipment Degree of ingress protection provided by ActaStim S enclosure Date of manufacture TECHNICAL WARRANTY Follow instructions for use Prescription only Serial number Storage humidity range Type BF applied part ǽǾ ...

Page 25: ...æ Ä Þê æ æË Ã ÞêÞ ËÚ Ä æɐ Ä Þ ÄËæ Ä ÃË Ĉ ËÚ Ú Ú ü ÄüËÄ Ëæ Ú æ Ä Ä ÚËõ c Ú Ä distributor or agent This warranty excludes the following consumable items that may need to be replaced after Ú Ë Ë æ Ã Ʌ Electrodes Battery Cables VËö Ú ê ü ə û ê Ä æ Ú Ú Ä Ú Ú Ë ºɚɋ c Þ ö ÚÚ Äæü ËÃ Ã ÄæÞ û Þæ Ä Ä æ ËÄ ê Ú Äæ Ë æ ËÄÞ Ä Ë Þ ÄËæ ą æ your statutory rights as a consumer cË Ã Þ Úõ êÄ Ú æ Þ ö ÚÚ ÄæüɆ Þ ËÄæ æ êÞ...

Page 26: ... Þ Ä ü ʱ Ã Äê æêÚ ËÚɅ Theragen Inc ǼǼǽǽǻ ÞÞ ææ ËË Ɇ æ ǼǻǼɆ C Ä ÞÞ Þ r ǽǻǼǻȄɆ g c Ʌ ǼɫȃǻǻɫȄǻǼɫȀȁȁȂ ActaStim com V ÚæɅ ǽǼǻǼɫǻǻǻǻ Y õɅ ǽ ÞÞê Ʌ Ǽǻɑǽǻ ǽȀ ...

Page 27: ...Part 2101 0001 Rev 2 Issued 10 20 ActaStim S Spine Fusion Stimulator QUICK START GUIDE ...

Page 28: ...site of spine fusion surgery area Clean and dry the skin before attaching the electrodes 2 2 B Connect Generator Cable or to Generator C 1b 1a 3 E Generator can be clipped on belt carried in a pocket or bag or placed on furniture 3 Insert Battery into Generator This turns on device including display audio vibrate Check back page for indicators D 4 3 1a or 1b 3 4 able 1a or 1b 2 2 3 3 ...

Page 29: ...Electrodes from Generator Cable Do not immerse in water See patient manual for additional safety information Charger Operation Battery Charging Orange Icon Night Mode Dimmer Switch Battery Charged Green Icon 5 5 6 8 7 Get started with ActaStim Sync Scan QR code or search ActaStim Sync in the AppStore or Google Play Download ActaStim Sync app Open app and follow the prompts 5 5 8 7 7 6 ...

Page 30: ...ged Green Check Treating Orange Electrodes Connection Issue Battery may be green ËÚ Ä ËÚ ĉ Þ Ä Orange Flashing Battery Need to change Battery DË Ú Ä º ʔ DËæ cÚ æ Ä Orange Triangle Product Fault Battery may be green ËÚ Ä ËÚ ĉ Þ Ä DË Ú Ä º ʔ DËæ cÚ æ Ä Orange Flashing Battery Triangle and Electrodes End of Product Life Orange Battery Need to make sure that Spare Battery is charging as current batter...

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