Use Instructions

OrthoSensor, Inc.
1855 Griffin Road
Suite A-310
Dania Beach, FL 33004-2200 USA
www.orthosensor.com
LB-5222 Rev. 1 (EN) 4
10-2019
For further information, contact the OrthoSensor Customer Service Center by phone at + 1 954-577-7770 or by e-mail at
[e-mail] or go to www.orthosensor.com.
VERASENSE FOR EXACTECH EQUINOXE TROUBLESHOOTING
Table 1
Issue
Cause
Solution
VERASENSE for Exactech Equinoxe LED
does not light up
VERASENSE for Exactech Equinoxe
batteries are dead
Discard VERASENSE for Exactech
Equinoxe and replace
VERASENSE for Exactech Equinoxe not
transmitting data to LinkStation MINI or
LinkStation MINI Evaluation Kit
VERASENSE for Exactech Equinoxe is
out of wireless range
Move LinkStation MINI or LinkStation
MINI Evaluation Kit closer to
VERASENSE for Exactech Equinoxe
Move LinkStation MINI or LinkStation
MINI Evaluation Kit to achieve an
unobstructed line-of-sight to the
VERASENSE for Exactech Equinoxe
field of use
VERASENSE for Exactech Equinoxe is
powered off
Activate with LinkStation MINI or
LinkStation MINI Evaluation Kit
magnet
VERASENSE for Exactech Equinoxe
device batteries are low
Discard VERASENSE for Exactech
Equinoxe and replace
VERASENSE for Exactech Equinoxe
breakage
VERASENSE for Exactech Equinoxe
applied load is beyond limit
VERASENSE for Exactech Equinoxe
internal components are non-sterile
and non-medical grade. Ensure
patient safety. Discard device and
replace.
Lag in reported data Software latency
Maintain shoulder position until data
settles (approximately 5 seconds)
Note: Should any of the issues above arise please contact OrthoSensor Customer service at + 1 954-577-7770 for
return or replacement assistance.
DECONTAMINATION OF PRODUCT RETURNED FOR COMPLAINT INVESTIGATION
This section applies to all VERASENSE for Exactech Equinoxe devices intended to be returned for complaint investigations. Any
device that has been opened/removed from sterile packaging and exposed to biohazardous material must be sent to central
processing within the hospital for decontamination according to this procedure prior to transport to OrthoSensor. The following
guidelines have been proven effective for cleaning VERASENSE for Exactech Equinoxe devices but are not guaranteed to result
in a safe handling environment or sterilized devices.
Note: Should a device be clearly marked as having been used on a patient with HIV or infectious disease of equivalent
risk, the device must not be decontaminated but rather documented and destroyed.
Decontamination Procedure:
1. Create cleaning solution in labeled cleaning container by combining 2 ounces (59 mL) of ENZOL Enzymatic detergent
(or equivalent*) per gallon (3.8 L) of warm water.
2. Soak device(s) for 5 minutes. If necessary, use brush to clean any dried-on material.
3. Thoroughly rinse device(s) with clean running water. Dry device(s) and place on clean absorbent pad.
4. Fill labeled disinfection container with enough Cidex OPA solution (or equivalent*) to cover device(s) completely.
5. Immerse device(s) in solution and soak for 15 minutes. Ensure that all devices are 100% covered by the solution.
6. Remove device(s) and rinse for at least one minute with a large volume of clean water. Dry device(s) and place
decontaminated parts on clean absorbent pad.
*If equivalent agent is used, it is recommended to follow manufacturer’s instructions for creating cleaning and
disinfectant solutions. Once this procedure has been carried out, devices may be packaged in the enclosed return
envelope and transported per instructions on return envelope.