Use Instructions

OrthoSensor, Inc.
1855 Griffin Road
Suite A-310
Dania Beach, FL 33004-2200 USA
www.orthosensor.com
LB-5190 Rev. 6 (EN) 6
08-2020
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 DEVICE SPECIFICATIONS
The VERASENSE for Biomet Vanguard, VERASENSE for Stryker Triathlon, VERASENSE for Zimmer NexGen, VERASENSE for Smith &
Nephew Legion, and VERASENSE for Smith & Nephew Journey II comply with Part 95 of the FCC rules. These devices may not
interfere with stations operating in the 400.150–406.000 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.
The VERASENSE for Zimmer Biomet Persona and VERASENSE for Stryker Triathlon with Bluetooth (check label on the front of the
sensor box for the Bluetooth symbol ) comply with Part 15(c) 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. 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 document the intended use environment and EMC compliance levels of
VERASENSE.
VERASENSE is intended for use in the electromagnetic environment specified in this IFU.
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 take mitigation
measures, such as relocating or re-orienting the equipment.
IEC 60601-1 Medical Electrical Equipment Classification for Protection Against Electrical Shock
Sensor: Internally powered (3.1 V dc)
VERASENSE for Stryker Triathlon, VERASENSE for Zimmer NexGen, VERASENSE for Biomet Vanguard,
VERASENSE for Smith & Nephew Journey II, and VERASENSE for Smith & Nephew Legion Devices: Internally
Powered by Energizer 362/361 battery.
VERASENSE for Zimmer Biomet Persona Devices: Internally powered by Renata CR1216 MFR FH battery.
LinkStation MINI / LinkStation MINI Evaluation Kit:
Transceiver: Class II USB powered and intended to be connected to the USB port of the LinkStation MINI
display unit (5 V dc).
Display Unit: Class I (65W universal 3-pin jack, 100-240V, 1.5A, 50-60Hz).