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IFU-0001-0001, Rev. D 

 

Page 3 of 14 

Operator Instructions: 

 

Make certain the unit is stable and on a flat surface; make sure the syringe does not contain excess fluid – 
any excess fluid must be discharged outside the device. 

 

Turn the Sharps Terminator

® 

on by pressing the On button once. The device will run a diagnostic sequence: 

turn on all LEDs, test the cutting mechanism, electrodes, swarf tube, and the UV light to assure device is fully 
functional. The solid blue LED light on the top of the device will illuminate when the unit is finished running 
this sequence and is ready to burn a needle.  

 

The device is designed to start burning the needle automatically when it is inserted. After the needle is 
consumed, the cutting blade will cut the burned needle tip. The cut and burned needle tip will then fall into 
the swarf collection tube. The white UV LED will illuminate for 1.5 minutes. During this time an additional 
needle may be burned after 7 seconds (See Test Burning below). The blue LED will remain on for 3 minutes 
after the last needle burned waiting for another needle. Then it will automatically shut off to conserve 
battery life. 

 

Using one hand, insert the needle straight into the opening on top of the device. Insert the needle downward 
with light to medium pressure while rotating or twisting the syringe. Heavy gauge needles will require a little 
more pressure than light gauge needles. Allow the device to consume the needle without forcing the needle 
into the 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 dispose of it in compliance with all regulations and guidelines in your area. Always follow all 
universal safety precautions when handling needles.  

 

The device has a feature to notify the user that the swarf tube is almost full. The device will hold 30 burned 
needle tips. On the 25

th

 through the 30

th

 needle cycle, the blue LED will flash 5 times after a burn cycle then 

return to solid blue indicating the swarf tube needs to be emptied soon. On the 30

th

 needle, the device will 

no longer allow burning and the swarf tube must be emptied.  

 

Test Burning

: When test burning needles to become familiar with the device, do not burn 18-20 gauge 

needles back-to-back. Wait at least 2 minutes between cycles. When burning 21 to 27 gauge needles, wait at 
least 1 minute between cycles. Use a stop watch for this if necessary.  

 

Miss Burns

: While learning to operate the device, you may encounter a partially burned needle. If this 

happens, simply re-insert the needle after 7 seconds and finish burning it. If there is metal still present on the 
syringe, discard the syringe and remaining needle nub into a sharps container. 

 

A small amount of smoke or a small spark may escape the needle seat. This is normal and should not be 
cause for alarm. This is a byproduct of the burning process.   

 

 

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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