SharpsAid Sharps Terminator User Manual Download

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IFU-0001-0001, Rev. D

Page 14 of 14

Reinstall swarf tube, needle ring and seat
turning clockwise to lock after insertion.

Test the device by turning it on, and test by
burning 2-3 needles.

User Guide Visual References:

Light Sequences: Quick Reference Guide

Normal Operation: SOLID LED LIGHT

Device ready to burn needle

Battery charged/plugged into charger

Battery needs charging soon/charging if

plugged into charger

UV light cycle active

Charging cycle active from discharge

Burning not allowed for 5 minutes

User Action Required: BLINKING LED LIGHT

Swarf collection tube removed or full

Battery discharged. Plug into charger

UV light not working

Motor/Cutter malfunction

Electrode block

Over current protection

IN SUCCESSION: WRONG CHARGER

Summary of Contents for Sharps Terminator

Page 1: ... cm The device is for use in treatment settings such as treatment rooms emergency trauma rooms wards and medication rooms of Hospitals and Outpatient Clinics Medical Offices Dental Offices and Clinical Laboratories Warnings DO NOT INSERT NEEDLES THAT CONTAIN FLAMMABLE LIQUIDS SUCH AS ALCOHOL OR RADIOACTIVE MATERIALS DO NOT USE IN EXPLOSIVE ATMOSPHERES SUCH AS HIGH OXYGEN OR THE PRESENCE OF FLAMMAB...

Page 2: ...ce to charge the device INCLUDED WITH YOUR Sharps Terminator 1 Sharps Terminator device 1 Wall charger 1 Swarf collection tube color black located underneath the device 2 Electrode clearing tools color red 1 in the upper packaging the other in the receptacle underneath the device 1 User guide with warranty information 1 Quick start guide with light codes on laminated card Do not throw away the pac...

Page 3: ...he device Lighter gauge needles are more easily bent and require much less downward pressure Note The needle must be inserted straight into the device The twisting or rotating action will allow more of the needle to be consumed closer to the needle hub especially for lighter gauge needles After the needle is destroyed and the cutter severs the burned tip remove the plastic syringe and immediately ...

Page 4: ...OWN The swarf tube is removed by turning counter clockwise 1 8 turn to the open position Remove the swarf tube from the bottom of the device Waste contents may occasionally have needle fragments and may not be sterile Dispose of waste contents in a puncture resistant bag or container and place with biohazard waste Re insert the swarf tube and turn 1 8 turn clockwise to the closed position NOTE The...

Page 5: ... the device on in order to reset the trouble code Electrode blocks are logged on the device See Page 10 White Red Blue flashing The over current protection device has been activated Allow the device to cool for 15 minutes If another needle is inserted into the device while it is cooling the error code will illuminate again Burning is not allowed if the O C P is activated Pushing the ON button afte...

Page 6: ...ject last visit Clinical Endpoints The primary safety endpoint was assessment of adverse events The primary efficacy endpoint was Destruction of the needle body to a blunt stub of 1 16 inch or less Rating 2 or 3 on a needle Destruction Scale for 95 of all tested needles in no more than 2 attempts There were no secondary endpoints but informational data on subject demographics as including occupati...

Page 7: ...m Tech Med Tech Para Medic CRC HS AS BS TECH DIPLOMA MS License Certified Registered Years M F Inches lbs Left Right 1 4 2 0 1 0 0 1 0 1 1 0 1 0 2 0 1 44 0 4 66 168 1 3 2 3 0 0 3 0 0 0 0 0 1 1 1 0 1 0 2 45 0 3 66 178 0 3 3 3 0 0 3 0 1 0 0 0 2 1 0 0 2 0 1 56 2 1 67 156 0 3 4 3 0 1 1 1 0 0 0 2 1 0 0 0 1 1 0 40 1 2 65 148 0 3 5 3 0 0 1 0 0 0 1 1 0 2 0 0 0 1 3 43 1 2 67 185 1 2 6 3 0 0 2 0 1 0 0 0 0 2...

Page 8: ...ewcombe R Interval estimation for the difference between independent proportions comparison of eleven methods Statistics in medicine 1998 17 873 890 Overall Conclusions from Clinical Data The Sharps Terminator performed well above the criteria established for success The ten non destruction events that occurred during the study did not subject the operator to danger and appeared to be related to t...

Page 9: ...vice in the US regulated by the FDA and the charger bears the UL marking for the U L The Sharps Terminator and charger bears the CE Marking for the EU The Sharps Terminator and its logos are registered trademarks Worldwide Patents Pending Do not use Glass syringes in this device ...

Page 10: ...ckwise locks the swarf collection tube Counterclockwise unlocks the swarf collection tube Electrode Clearing Tool Clears electrode blocks and is used to clean the electrodes Front of Device Warning Label Please read and understand Rear Charging Port Only use charger supplied with the device Electrode area Insert cleaning clearing tool between electrodes DO NOT insert metal objects Wear safety glas...

Page 11: ... Test burn several needles to be sure satisfactory results are achieved before burning contaminated syringe needles Short cuts and miss cuts are common with first time users Do not exceed duty rating of the device 18 20 gauge needles 2 minutes between burns 21 27 gauge needles 1 minute between burns Caution Use only with plastic syringes Needle Range 18 27gauge up to 2 length Discard excess fluid ...

Page 12: ...e removing swarf collection tube Contents may empty into the device Swarf Tube may be warm to touch Swarf Tube Removed 2 Discard contents into a puncture resistant container Caution Do not touch needle remains as they may be hot or contaminated 3 Re insert swarf collection tube into the device Align tabs and turn clockwise 1 8 turn to lock it back into the device Set device back down and resume no...

Page 13: ... needle ring and swarf tube back into the device turning clockwise to lock each 10 Test the device by turning it on and test burning 2 to 3 needles 11 DO NOT insert metal picks or screw drivers into the device This will damage the electrodes and void your warranty Use the plastic picks supplied If you need additional picks please contact your Sharps Terminator distributor or the service center UV ...

Page 14: ...tion SOLID LED LIGHT Device ready to burn needle Battery charged plugged into charger Battery needs charging soon charging if plugged into charger UV light cycle active Charging cycle active from discharge Burning not allowed for 5 minutes User Action Required BLINKING LED LIGHT Swarf collection tube removed or full Battery discharged Plug into charger UV light not working Motor Cutter malfunction...

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