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SharpsAid Sharps Terminator User Manual
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SharpsAid Sharps Terminator User Manual

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Sharps Terminator
Please read carefully and follow all instructions.
Device Description Overview
®
The Sharps Terminator
is designed to safely destroy 18-27 gauge needles up to 2 inches (approx. 5 cm) in length
attached to syringes 3 – 20 cc. The needle is destroyed by inserting it vertically into the center of the opening on top
®
of the Sharps Terminator
syringe firmly until the tip cutting motor ceases and UV indicator light illuminates. The debris (swarf) left from the
needle destruction is collected in the swarf collection tube and is emptied after 30 device cycles. The Sharps
®
Terminator
operates from an internal rechargeable NiMH battery pack. The battery pack can be recharged using the
®
Sharps Terminator
power supply that comes with the unit. The Sharps Terminator
the charger or used remotely until the battery is discharged. The device is able to burn 40 to over 200 needles per
charge, depending on needle gauge and length burned.
Indications for Use
®
The Sharps Terminator
product is a stationary or portable needle destruction device that is intended for use by
individuals and healthcare professionals to safely destroy 18-27 gauge needles up to 2 inches (approx. 5 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 FLAMMABLE VAPORS.
MINOR SPARKING OR SMOKING MAY OCCUR FROM NEEDLE SEAT. DO NOT OPERATE UNIT WITH NEEDLE RING AND
SEAT REMOVED.
DO NOT HANDLE CONTENTS OF THE SWARF TUBE AS THEY MAY BE HOT OR CONTAMINATED
IN THE EVENT THE UNIT FAILS TO OPERATE OR DESTROY A NEEDLE, DISPOSE OF SHARPS IN A SHARPS CONTAINER
Additional Precautions
Use only one hand to operate the device. It is designed for simple one-handed use to avoid your other hand becoming
a target for a needle stick.
DO NOT immerse or subject the device to high moisture.
DO NOT use other charger types than the one included with your device.
DO NOT empty liquid contents of the syringe into the device.
DO NOT insert metal or glass syringes into the device.
DO NOT insert metal picks or screwdrivers into the device. Use the cleaning pick supplied
DO NOT discharge any excess fluid into the device – discharge any excess fluid prior to use outside the
device.
Directions for Use:
Important! There is no substitute for CAUTION when handling needles (sharps). This product does not eliminate the
need to follow existing regulations and best practices regarding the handling of needles. Improper use or
IFU-0001-0001, Rev. D
®
User Guide
. Rotate or twist the needle while pressing downward until it can go no further. Hold the
®
can be used while plugged into
.
Page 1 of 14

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Summary of Contents for SharpsAid Sharps Terminator

  • Page 1 ® Sharps Terminator power supply that comes with the unit. The Sharps Terminator can be used while plugged into the charger or used remotely until the battery is discharged. The device is able to burn 40 to over 200 needles per charge, depending on needle gauge and length burned.
  • Page 2 OSHA regulations and good practices for safety. ® PRIOR TO USING YOUR Sharps Terminator FOR THE FIRST TIME Important! It is required that the user become familiar with the device by reading this user guide then test burning several sterile needles of different sizes until the user becomes familiar with operation of the device and satisfactory results are achieved.

  • Page 3: Operator Instructions

     ® 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.
  • Page 4 Wrong charger plugged into the device. ® Removing Needle Waste from the Sharps Terminator Caution! Immediately after burning a needle, the contents in the collection tube are extremely HOT! Do not empty the contents while the UV guard LED is illuminated to allow for cooling. Ignoring this mandate can result in serious burns and/or fire! Use of gloves is recommended when disposing of swarf.

  • Page 5: Troubleshooting Instructions

    ® De-Commissioning the Sharps Terminator ® Do not deposit the device in the trash. Return your decommissioned Sharps Terminator to the Service and Warranty Center located on the rear of the device. The battery is not removable by the user.
  • Page 6 Success/Failure criteria: The success of the Sharps Terminator was based upon the following clinical criteria being met at the completion of the study: 1. Destruction of the needle body to a blunt “stub” of 1/16 inch or less in length (Rating 1 or 3 on the needle Destruction Scale) for 95% of all tested needles.
  • Page 7  Screening/Consent/Enrollment  Training  Device Installation/Inventory/Location Form  Completion of Demographic Data  Assignment of Sharps Kit  Sharps Destruction/ Completion of Sharps Destruction Log  Photography of Location and destroyed Sharps  Completion of User Satisfaction Questionnaire  AE assessment ...

  • Page 8: Warranty

    If the safety seal is broken or missing warranty is void. For all warranty claims in North America, please call Sharps Terminator Service center at 251-947-2265, the telephone number located on the rear of the device, or e mail TerminatorService@sharpsterminator.com.
  • Page 9 The Sharps Terminator® is a Class 3 Medical Device 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.
  • Page 10 User Guide Visual References: Blue LED: On/Swarf indicator UV LED: Active UV cycle Battery LED: Battery level indicator red/yel./green Needle Seat: Needle insertion point Needle Ring: Houses needle seat/spark guard On Button: Push once Top view of device Rubber Feet Swarf Collection Tube: Collects needle remains.
  • Page 11 User Guide Visual References: Operation: Quick Start Guide Turn device on. Allow self-check sequence to operate. Solid blue LED will illuminate when the Hold on to the syringe until cutter stops. device is ready. Pull up and remove syringe. Plug device into wall charger. If an error occurs, see troubleshooting guide.
  • Page 12 User Guide Visual References: Emptying Swarf Collection Tube: Discard contents into a puncture resistant container Caution: Do not touch needle remains as they may be hot or contaminated. Pick up device with one hand. With the other hand, grasp the handle on the swarf collection tube and turn 1/8 turn counter- clockwise.
  • Page 13 If you need additional picks please contact your Sharps Terminator® distributor or the service center. User Guide Visual References: Maintenance: Electrode Cleaning UV Bulb Removal/Installation 1. Put on safety glasses and protective gloves. 2. Remove needle ring and swarf tube by turning each 1.
  • Page 14 7. Reinstall swarf tube, needle ring and seat 8. Test the device by turning it on, and test by turning clockwise to lock after insertion. 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...