Use Instructions

OrthoSensor, Inc.
1855 Griffin Road
Suite A-310
Dania Beach, FL 33004-2200 USA
www.orthosensor.com
LB-5222 Rev. 1 (EN) 5
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 DEVICE SPECIFICATIONS
This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this device may not
cause harmful interference, and (2) this device must accept any interference received, including interference that may cause
undesired operation.
The VERASENSE for Exactech Equinoxe complies with Part 95 of the FCC rules. This device does not interfere with stations
operating in the 2402-2480 MHz band in the Meteorological Aids, Meteorological Satellite, and Earth Exploration Satellite
Services and must accept any interference received, including interference that may cause undesired operation.
Modification of this device may void the user’s authority to operate the equipment under the FCC rules above.
This equipment has been tested and found to comply with IEC 60601-1 - Medical electrical equipment - Part 1: General
requirements for basic safety and essential performance.
This equipment has been tested and found to comply with the EMC limits for the Medical Device Directive 93/42/EEC (EN
60601-1-2). No essential performance was identified and tested. These limits are designed to provide reasonable protection
against harmful interference in a typical medical installation. This equipment generates and uses radio frequency energy and, if
not installed and used in accordance with the instructions, may cause harmful interference to other devices in the vicinity.
However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause
harmful interference with other devices, which can be determined by turning the equipment off and on, the user is encouraged
to try to correct the interference by one or more of the following measures:
- Reorient or relocate the receiving device.
- Increase the separation between the equipment.
- Connect the equipment into an outlet on a circuit different from that to which the other device(s) is connected.
- Consult OrthoSensor for help.
For additional safety information, see Table 4 which documents the EMC compliance levels of VERASENSE for Exactech
Equinoxe.
VERASENSE for Exactech Equinoxe is intended for use in a professional healthcare facility environment.
Note: The emissions characteristics of this equipment make it suitable for use in industrial areas and hospitals (CISPR
11 class A). If it is used in a residential environment (for which CISPR 11 class B is normally required) this equipment
might not offer adequate protection to radio-frequency communication services. The user might need to make
mitigation measures, such as relocating or re-orienting the equipment.
ADDITIONAL WARNINGS
• Only use the accessories supplied with the LinkStation MINI or LinkStation MINI Evaluation Kit. This includes the USB cable,
power cord, mounting fixtures, etc.
• Do not power the transceiver from any device other than the provided LinkStation MINI or LinkStation MINI Evaluation Kit.
• Do not connect any other devices to the display unit input/output ports other than those supplied with the LinkStation MINI
or LinkStation MINI Evaluation Kit.
• WARNING: No modification of this equipment is allowed.
• Modification is only allowed by the manufacturer of this equipment.
• WARNING: Portable RF communications equipment (including peripherals such as antenna cables and external antennas)
should be used no close than 30 cm to any part of the VERASENSE for Exactech Equinoxe and accessories, including cables
specified by the manufacturer. Otherwise, degradation of performance of this equipment could result.
• Transceiver cleaning and disinfection instructions: wipe transceiver down with 70% isopropyl alcohol wipes after each use.