Use Instructions

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OrthoSensor, Inc.

1855 Griffin Road

Suite A-310

Dania Beach, FL 33004-2200 USA

www.orthosensor.com

LB-5190 Rev. 6 (EN) 5

08-2020

For further information, contact the OrthoSensor Customer Service Center by phone at + 1 954-577-7770 or by e-mail

at customerservice@orthosensor.com or go to www.orthosensor.com.

VERASENSE TROUBLESHOOTING

Table 1

Issue

Cause

Solution

VERASENSE device LED does not light up VERASENSE device batteries are dead

Discard VERASENSE device and

replace

VERASENSE Device not transmitting data

to LinkStation MINI or LinkStation MINI

Evaluation Kit

VERASENSE device is out of wireless

range

Move LinkStation MINI or LinkStation

MINI Evaluation Kit closer to

VERASENSE device

Move LinkStation MINI or LinkStation

MINI Evaluation Kit to achieve an

unobstructed line-of-sight to the

VERASENSE device field of use

VERASENSE device is powered off

Activate with LinkStation MINI or

LinkStation MINI Evaluation Kit

magnet

VERASENSE device batteries are low

Discard VERASENSE device and

replace

VERASENSE device breakage

VERASENSE device applied load is

beyond limit

VERASENSE device internal

components are potentially non-

sterile and non-medical grade.

Ensure patient safety. Discard device

and replace.

Lag in reported data Software latency

Maintain knee 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 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 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.