VeraSense Instructions for Use Rev 11

OrthoSensor, Inc. 1855 Griffin Road Suite A-310 Dania Beach, FL 33004-2200 USA www.orthosensor.com

• Do not forcibly impact femoral implant trial onto the VERASENSE device placed in tibial tray. • Do not attempt to use the VERASENSE device without selection and use of proper shim and appropriately sized tibial tray. • If VERASENSE device or shim set packaging is open or damaged, do not use and immediately return to OrthoSensor. • Maximum allowable load for the VERASENSE device is 70 lbf (311 N) per compartment. If the physician perceives a difference between the loads displayed on the screen and the physical feel, the physician should either replace the device or continue the procedure using their standard instrumented trial technique and best clinical judgment. Note: Load values between 41-70 lbf (181 – 311 N) are displayed for reference only. Note: If maximum allowable load of 70 lbf (311 N) is reached in either compartment, the VERASENSE device must be removed from the knee joint and “re-zeroed” by holding VERASENSE with superior side (articulating surface) facing the floor for three (3) seconds, Re-Zero enabled will appear on the VERASENSE Software Application, followed by Re-Zero Complete indicating that VERASENSE has been reset to zero; or Re-Zero button from the VERASENSE Software Application by Pressing the Re-Zero button. Compartment Re-Zero allows for a re-zero of the device without removing it from the joint. With VERASENSE in the joint, apply a varus or valgus thrust to the knee to off-load the desired medial or lateral compartment. When the VERASENSE surface is visually unloaded, select the laterality indicator of the unloaded side to initiate the ReZero. Wait for Re-Zero Enabled and Re-Zero Completed messages to display. Repeat the steps on the opposite compartment to complete the Re-Zero. Note: Compartment Re-Zero is only available with VERASENSE devices that communicate with the LinkStation MINI via Bluetooth. Check label on the front of the sensor box for the Bluetooth symbol . • Do not use a prying device during surgical procedure while the VERASENSE device is in place as this may result in damage to the exterior of the device. • Perform load measurements without the patella everted to avoid altered compartmental loads. • It is recommended to evaluate compartment loads and joint balance with the patella reduced and the capsule closed. • Verify ligament balancing after final cementation to avoid altered joint balance. • Clinician learning curve for the use of VERASENSE and accessories during surgery is estimated to possibly cause the following complications to the patient. • Prosthetic instability caused from incorrect reference of ligament tension, implant positioning and varus/valgus angles. • Patient infection caused from the delay in surgery. • Only use the necessary accessories for the operation of the VERASENSE. • 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 VERASENSE. • Do not modify this equipment. • Observe all warnings generated by the VERASENSE Software Application. • VERASENSE for Zimmer Biomet Persona contains lithium batteries, thus special disposal instructions should be taken in the state of California, USA. The device cannot be incinerated. • Modification of this device may void the user’s authority to operate the equipment under the FCC rules. • Federal law restricts this device to sale by or on the order of a licensed physician. PRECAUTIONS • Read and follow instructions for proper use and interpretation of force data displayed. • Refer to appropriate implant knee system IFU for additional precautions. • The VERASENSE device and shim sets are supplied as single-use sterile. Do not reuse or re-sterilize. • Do not use VERASENSE device after the expiration date printed next to symbol on the package labeling. • Do not use the VERASENSE device without a shim attached in the tibial tray for the VERASENSE for Stryker Triathlon Sizes 3-6, VERASENSE for Biomet Vanguard, or VERASENSE for Zimmer Biomet Persona devices. • When detaching a shim from the VERASENSE device, detach anterior lip first, do not pry off posterior edge. Note: For the VERASENSE for Zimmer Biomet Persona, detach shim by prying on the posterior edge.

LB-5190 Rev. 11 (EN) 11-2021

2 For further information, contact the OrthoSensor Customer Service Center by phone at + 1 954-577-7770 or by e-mail at [email protected] or go to www.orthosensor.com.

OrthoSensor, Inc. 1855 Griffin Road Suite A-310 Dania Beach, FL 33004-2200 USA www.orthosensor.com

• Locate the version of the VERASENSE Software Application (VSA) in the bottom right corner of the LinkStation MINI or LinkStation MINI display unit. Confirm the version number of the VSA is greater than 5.1.0.17 for use with VERASENSE for Zimmer Biomet Persona and greater than 5.3.0.64 for use with VERASENSE for Stryker Triathlon with Bluetooth. Check label on the front of the sensor box for the Bluetooth symbol . • Do not use VERASENSE device if it appears to be functioning improperly. • Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm to any part of the VERASENSE and accessories, including cables specified by the manufacturer. Otherwise, degradation of performance of this equipment could result.

INSTRUCTIONS 1. Confirm the LinkStation MINI or LinkStation MINI Evaluation Kit is setup appropriately outside of the sterile field. Refer to the VERASENSE User Guide. The LinkStation MINI or LinkStation MINI Evaluation Kit is located outside of the sterile field and the VERASENSE device and shims are used within the sterile field. 2. Determine the specific implant type and size VERASENSE device required. Remove pouched Shims and device from the box. DO NOT OPEN POUCH SEALS. a. Do not use if device or shim set packaging has been opened or damaged. 3. Record VERASENSE device serial number ( ) onto patient and hospital records as required. 4. To activate the VERASENSE device: a. With the product still in the sealed pouches, place the device directly over the magnet on LinkStation MINI or LinkStation MINI Evaluation Kit. An LED light will illuminate on the device. Do not move the device until you observe the following: i. LED turns off after approximately four (4) seconds. ii. VERASENSE Software Application launches. iii. Locate the version of the VERASENSE Software Application (VSA) in the bottom right corner of the LinkStation MINI or LinkStation MINI display unit. Confirm the version number of the VSA is greater than 5.1.0.17 for use with VERASENSE for Zimmer Biomet Persona and greater than 5.3.0.64 for use with VERASENSE for Stryker Triathlon with Bluetooth. Check label on the front of

5. 6. 7. 8.

9.

the sensor box for the Bluetooth symbol . iv. Initialization progress bar appears and completes. v. Prompt to select left or right leg appears. b. Device may now be removed from magnet. The VERASENSE Software Application will automatically prompt selection of left or right leg. Select the appropriate operative leg. Upon completion of the device initiation process as prompted on the VERASENSE Software Application, pass the sealed pouches to the nurses within the sterile field of the operating room. Open double sealed pouches per hospital protocol (VERASENSE device and shim set). With the VERASENSE device and shims removed from the pouches, apply designated shim to underside of VERASENSE device. Note: The VERASENSE for Zimmer Biomet Persona device shim attaches to the top of the device. Attach by inserting the devices anterior tab into the anterior loop on the shim, engage the posterior snapping mechanism by squeezing the assembly together. Input the selected shim thickness within the VERASENSE Software Application. Note: Once the product is removed from the pouch, the application of the initial shim, if applicable, relates to devices without mounted shims (VERASENSE for Stryker Triathlon Sizes 2 & 7, VERASENSE for Zimmer NexGen, VERASENSE for Smith & Nephew Journey II, and VERASENSE for Smith & Nephew Legion). Apply desired shim to all VERASENSE for Stryker Triathlon 3-6, VERASENSE for Biomet Vanguard, and VERASENSE for Zimmer Biomet Persona devices prior to use. To remove the shim, or exchange for another size, simply unsnap the anterior lip of the attached shim and replace. Note: VERASENSE for Zimmer Biomet Persona shim is removed by distracting the posterior aspect of the device from shim. This releases the posterior snapping mechanism.

LB-5190 Rev. 11 (EN) 11-2021

3 For further information, contact the OrthoSensor Customer Service Center by phone at + 1 954-577-7770 or by e-mail at [email protected] or go to www.orthosensor.com.

OrthoSensor, Inc. 1855 Griffin Road Suite A-310 Dania Beach, FL 33004-2200 USA www.orthosensor.com

10. With the VERASENSE device and shim attached, physician should manually compress / apply load to the device and verify the response on the User Interface prior to placing VERASENSE device into the tibial tray. 11. Place VERASENSE within tibial tray. 12. Confirm that the VERASENSE device with shim is fully seated when placed in the tibial tray. 13. Flex the joint throughout its full range of motion to ensure appropriate response on the User Interface. 14. Proceed with TKA process per physician / hospital protocol. Note: If maximum allowable load of 70 lbf (311 N) is reached in either compartment, the VERASENSE device must be removed from the knee joint and “re-zeroed” by holding VERASENSE with superior side (articulating surface) facing the floor for three (3) seconds, Re-Zero enabled will appear on the VERASENSE Software Application, followed by Re-Zero Complete indicating that VERASENSE has been reset to zero; or Re-Zero button from the VERASENSE Software Application by Pressing the Re-Zero button. a.

Compartment Re-Zero allows for a re-zero of the device without removing it from the joint. With VERASENSE in the joint, apply a varus or valgus thrust to the knee to off-load the desired medial or lateral compartment. When the VERASENSE surface is visually unloaded, select the laterality indicator of the unloaded side to initiate the Re-Zero. Wait for Re-Zero Enabled and Re-Zero Completed messages to display. Repeat the steps on the opposite compartment to complete the Re-Zero. Note: Compartment Re-Zero is only available with VERASENSE devices that communicate with the LinkStation MINI via Bluetooth. Check label on the front of the sensor box for the Bluetooth symbol

.

15. In VSA 5.3.0.64 or greater, when a VERASENSE for Zimmer Biomet Persona device is activated with the magnet, the user must acknowledge a description of the recommended workflow to handle temperature conditioning of the device prior to use. a. b. c.

After device is inserted into the knee, pressing the CONDITION or button on the VSA. After conditioning is complete, follow the instructions to unload and immediately re-zero sensor. Repeat this Step 15 if the VERASENSE for Zimmer Biomet Persona device is removed from the knee.

16. Upon completion of the procedure, deactivate the VERASENSE Software Application by pressing the Exit Button on the User Interface. 17. Dispose of the VERASENSE device per institutional guidelines for biohazardous medical waste. Note: VERASENSE for Zimmer Biomet Persona contains lithium batteries, thus special disposal instructions should be taken in the state of California, USA. The device cannot be incinerated.

Model VERASENSE for Biomet Vanguard VERASENSE for Stryker Triathlon VERASENSE for Zimmer NexGen VERASENSE for Smith & Nephew Legion VERASENSE for Smith & Nephew Journey II VERASENSE for Zimmer Biomet Persona

LB-5190 Rev. 11 (EN) 11-2021

Measurement Load Range

5 – 40 lbf per compartment (22 – 180 N)

Load Accuracy

≤3.5 lbf (16 N)

4 For further information, contact the OrthoSensor Customer Service Center by phone at + 1 954-577-7770 or by e-mail at [email protected] or go to www.orthosensor.com.

OrthoSensor, Inc. 1855 Griffin Road Suite A-310 Dania Beach, FL 33004-2200 USA www.orthosensor.com

VERASENSE TROUBLESHOOTING Table 1 Issue

Cause

VERASENSE device LED does not light up

VERASENSE device batteries are dead

VERASENSE device is out of wireless range VERASENSE Device not transmitting data to LinkStation MINI or LinkStation MINI Evaluation Kit VERASENSE device is powered off VERASENSE device batteries are low

VERASENSE device breakage

VERASENSE device applied load is beyond limit

Lag in reported data

Software latency

Solution Discard VERASENSE device and replace 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 Activate with LinkStation MINI or LinkStation MINI Evaluation Kit magnet Discard VERASENSE device and replace VERASENSE device internal components are potentially nonsterile and non-medical grade. Ensure patient safety. Discard device and replace. 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.

LB-5190 Rev. 11 (EN) 11-2021

5 For further information, contact the OrthoSensor Customer Service Center by phone at + 1 954-577-7770 or by e-mail at [email protected] or go to www.orthosensor.com.

OrthoSensor, Inc. 1855 Griffin Road Suite A-310 Dania Beach, FL 33004-2200 USA 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 15I 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 24022480 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 606011-2). 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). EQUIPMENT NOT SUITABLE FOR USE IN THE PRESENCE OF A FLAMMABLE ANAESTHETIC MIXTURE WITH AIR OR WITH OXYGEN OR CONTINUOUS FLOW OF NITROUS OXIDE. CONTINUOUS OPERATION WITH SHORT-TIME LOADING.

LB-5190 Rev. 11 (EN) 11-2021

6 For further information, contact the OrthoSensor Customer Service Center by phone at + 1 954-577-7770 or by e-mail at [email protected] or go to www.orthosensor.com.

OrthoSensor, Inc. 1855 Griffin Road Suite A-310 Dania Beach, FL 33004-2200 USA www.orthosensor.com

Table 2 – Symbols

Type:

Do not re-sterilize Single Procedure use / Do not re-use

Prescription: Sterility:

Manufacturer:

By Prescription Only Sterilized using ethylene oxide

OrthoSensor, Inc. 1855 Griffin Road Suite A-310 Dania Beach, FL 33004-2200 USA

Date of Manufacture: Australian & New Zealand Regulatory Compliance Mark (RCM) Device Type:

Type BF (sensor only)

Caution:

Use:

Do not use if package is damaged Non-pyrogenic Non-ionizing Radiation Ingress Protection Rating Consult User Guide Bluetooth® Symbol

Temperature Conditioning Shelf Life:

Use-by date Batch Code Serial number

Identification:

Quantity Catalog number

LB-5190 Rev. 11 (EN) 11-2021

7 For further information, contact the OrthoSensor Customer Service Center by phone at + 1 954-577-7770 or by e-mail at [email protected] or go to www.orthosensor.com.

OrthoSensor, Inc. 1855 Griffin Road Suite A-310 Dania Beach, FL 33004-2200 USA www.orthosensor.com

Authorized Representative in the European Community

Australia Sponsor

New Zealand Sponsor

Emergo Europe Prinsessegracht 20 2514 AP The Hague The Netherlands Stryker Australia Pty Ltd 8 Herbert Street St Leonards NSW 2065 T: 61 2 9467 1000 F: 61 2 9467 1010 Stryker New Zealand Limited PO Box 17-136 Greenlane, Auckland 1546 T: 64 9 573 1894 F: 64 9 573 1895

EC

REP

CE Mark and Notified Body Number Model

FCC ID:

Japanese Radio Law Certification (Giteki Symbol)

Korea Certification (KC) Mark

Taiwanese Radio Law Certification (NCC) Mark

Operating Range: Power Supply: Battery Life:

LB-5190 Rev. 11 (EN) 11-2021

VERASENSE for Stryker Triathlon VERASENSE for Biomet Vanguard Transceiver VERASENSE for Zimmer NexGen VERASENSE for Smith & Nephew Journey II VERASENSE for Smith & Nephew Legion VERASENSE for Zimmer Biomet Persona VERASENSE for Stryker Triathlon (with Bluetooth) Model

FCC ID

Frequency band

Modulation

EIRP

XNL-ORTHOSNSR1

402.0 - 405.0 MHz

GFSK

1.83 nW

XNL-ORTHOSNSR2

404.3 - 404.3 MHz

GFSK

3.314 nW

XNL-ORTHOSNSR3

401.05 - 405.55 MHz

GFSK

N/A

XNL-ORTHOSNSR5

404.3 - 404.3 MHz

GFSK

1.31 µW

XNL-ORTHOSNSR7

2402 - 2480 MHz

GFSK

6 µW

XNL-ORTHOSNSR10

2402 - 2480 MHz

GFSK

0.77 mW

Symbol

VERASENSE for Zimmer Biomet Persona VERASENSE for Stryker Triathlon (with Bluetooth) Tablet component of LinkStation MINI and LinkStation MINI Evaluation Kit VERASENSE for Stryker Triathlon (with Bluetooth) Tablet component of LinkStation MINI and LinkStation MINI Evaluation Kit 6.5 ft [2m] Unobstructed

Conducted Power

2.1 mW

Certification Number 209-J00365

R-R-OK5-SYK-TRCR06

R-R-OK5-LINKSTATION

CCAI21LP1380T1

CCAI20LP1700T1

Internally powered at less than 3.3 VDC 40 minutes (approximate)

8 For further information, contact the OrthoSensor Customer Service Center by phone at + 1 954-577-7770 or by e-mail at [email protected] or go to www.orthosensor.com.

OrthoSensor, Inc. 1855 Griffin Road Suite A-310 Dania Beach, FL 33004-2200 USA www.orthosensor.com

VERASENSE 37°C

50°C

Temperature Limit: 15°C

0°C 100%, submersion

Relative Humidity:

80%, non-condensing

Storage

Operation 30%

10% 106 kPa

106 kPa

Atmospheric Pressure: 47 kPa

36 kPa

LinkStation MINI and LinkStation MINI Evaluation Kit 50°C

60°C

Temperature Limit: Operation

-10°C

Storage

95%, submersion

0°C 95%, non-condensing

Relative Humidity: 5%

5%

Made in Korea

Table 3 – Catalog Numbers VERASENSE Device Model

VERASENSE for Biomet Vanguard

VERASENSE Catalog Number

Global Trade Identification Number (GTIN)

Size

Compatible Implant System Catalog Number

BMT-VGCR63

63/67

32-483720, 32-483722, 32-483724, 32-483726, 32-483728

BMT-VGCR71

71/75

32-483740, 32-483742, 32-483744, 32-483746, 32-483748

BMT-VGCR79

79/83

32-483760, 32-483762, 32-483764, 32-483766, 32-483768

BMT-VGPS63

63/67

32-483820, 32-483822, 32-483824, 32-483826, 32-483828

BMT-VGPS71

71/75

32-483840, 32-483842, 32-483844, 32-483846, 32-483848

BMT-VGPS79

79/83

32-483860, 32-483862, 32-483864, 32-483866, 32-483868

00816818021539 SYK-TRCR02

5530-T-209, 5530-T-211, 5530-T-213, 5530-T-216

2 00816818022253

VERASENSE for Stryker Triathlon

00816818021546 SYK-TRCR03

5530-T-309, 5530-T-311, 5530-T-313, 5530-T-316

3 00816818022260

SYK-TRCR04

LB-5190 Rev. 11 (EN) 11-2021

00816818021553

5530-T-209, 5530-T-210, 5530-T-211, 5530-T-212,5530-T-213, 5530-T-216

4

5530-T-309, 5530-T-310, 5530-T-311, 5530-T-312, 5530-T-313, 5530-T-316 5530-T-409, 5530-T-411, 5530-T-413, 5530-T-416

9 For further information, contact the OrthoSensor Customer Service Center by phone at + 1 954-577-7770 or by e-mail at [email protected] or go to www.orthosensor.com.

OrthoSensor, Inc. 1855 Griffin Road Suite A-310 Dania Beach, FL 33004-2200 USA www.orthosensor.com

Table 3 – Catalog Numbers 5530-T-409, 5530-T-410, 5530-T-411, 5530-T-412, 5530-T-413, 5530-T-416

00816818022277 00816818021560 SYK-TRCR05

5530-T-509, 5530-T-511, 5530-T-513, 5530-T-516

5 00816818022284 00816818021577

SYK-TRCR06

5530-T-609, 5530-T-611, 5530-T-613, 5530-T-616

6 00816818022291 00816818021584

SYK-TRCR07

VERASENSE for Smith & Nephew Journey II

VERASENSE for Smith & Nephew Legion

LB-5190 Rev. 11 (EN) 11-2021

5530-T-609, 5530-T-610, 5530-T-611, 5530-T-612, 5530-T-613, 5530-T-616 5530-T-709, 5530-T-711, 5530-T-713, 5530-T-716

7 00816818022307

VERASENSE for Zimmer NexGen

5530-T-509, 5530-T-510, 5530-T-511, 5530-T-512, 5530-T-513, 5530-T-516

5530-T-709, 5530-T-710, 5530-T-711, 5530-T-712, 5530-T-713, 5530-T-716

ZMR-NGCRCH34

C-H/3-4

00-5971-030-10, 00-5971-030-12, 00-5971-030-14, 00-5971-030-17

ZMR-NGCRCH56

C-H/5-6

00-5971-040-10, 00-5971-040-12, 00-5971-040-14, 00-5971-040-17

ZMR-NGCRCH70

C-H/7-10

00-5971-050-10, 00-5971-050-12, 00-5971-050-14, 00-5971-050-17

ZMR-NGPSCD34

C-D/3-4

00-5961-030-10, 00-5961-030-12, 00-5961-030-14, 00-5961-030-17

ZMR-NGPSEF34

E-F/3-4

00-5961-032-10, 00-5961-032-12, 00-5961-032-14, 00-5961-032-17

ZMR-NGPSEF56

E-F/5-6

00-5961-040-10, 00-5961-040-12, 00-5961-040-14, 00-5961-040-17

SNN-JRNYBCS12-L

1-2 Left

74027221, 74027222, 74027223, 74027224, 74027225

SNN-JRNYBCS12-R

1-2 Right

74027211, 74027212, 74027213, 74027214, 74027215

SNN-JRNYBCS34-L

3-4 Left

74027241, 74027242, 74027243, 74027244, 74027245

SNN-JRNYBCS34-R

3-4 Right

74027231, 74027232, 74027233, 74027234, 74027235

SNN-JRNYBCS56-L

5-6 Left

74027261, 74027262, 74027263, 74027264, 74027265

SNN-JRNYBCS56-R

5-6 Right

74027251, 74027252, 74027253, 74027254, 74027255

SNN-JRNYBCS78-L

7-8 Left

74027281, 74027282, 74027283, 74027284, 74027285

SNN-JRNYBCS78-R

7-8 Right

74027271, 74027272, 74027273, 74027274, 74027275

SNN-JRNYCR12-L

1-2 Left

74025621, 74025622, 74025623, 74025624, 74025625

SNN-JRNYCR12-R

1-2 Right

74025611, 74025612, 74025613, 74025614, 74025615

SNN-JRNYCR34-L

3-4 Left

74025641, 74025642, 74025643, 74025644, 74025645

SNN-JRNYCR34-R

3-4 Right

74025631, 74025632, 74025633, 74025634, 74025635

SNN-JRNYCR56-L

5-6 Left

74025661, 74025662, 74025663, 74025664, 74025665

SNN-JRNYCR56-R

5-6 Right

74025651, 74025652, 74025653, 74025654, 74025655

SNN-JRNYCR78-L

7-8 Left

74025681, 74025682, 74025683, 74025684, 74025685

SNN-JRNYCR78-R

7-8 Right

74025671, 74025672, 74025673, 74025674, 74025675

SNN-LGNPS12

1-2

71453201, 71453171, 71453202, 71453172, 71453203

SNN-LGNPS34

3-4

71453211, 71453173, 71453212, 71453174, 71453213

10 For further information, contact the OrthoSensor Customer Service Center by phone at + 1 954-577-7770 or by e-mail at [email protected] or go to www.orthosensor.com.

OrthoSensor, Inc. 1855 Griffin Road Suite A-310 Dania Beach, FL 33004-2200 USA www.orthosensor.com

Table 3 – Catalog Numbers

VERASENSE for Zimmer Biomet Persona

SNN-LGNPS56

5-6

71453221, 71453175, 71453222, 71453176, 71453223

SNN-LGNPS78

7-8

71453231, 71453177, 71453232, 71453178, 71453233

SNN-LGNCR12

1-2

71453101, 71453181, 71453102, 71453182, 71453103

SNN-LGNCR34

3-4

71453111, 71453183, 71453112, 71453184, 71453113

SNN-LGNCR56

5-6

71453121, 71453185, 71453122, 71453186, 71453123

SNN-LGNCR78

7-8

71453131, 71453187, 71453132, 71453188, 71453133

ZBH-PSNCRCD39-L

00816818021478

ZBH-PSNCRCD39-R

00816818021485

ZBH-PSNCREF311-L

00816818021492

ZBH-PSNCREF311-R

00816818021508

ZBH-PSNCRGH712-L

00816818021515

ZBH-PSNCRGH712-R

00816818021522

C-D/3-9 Left C-D/3-9 Right E-F/3-11 Left E-F/ 3-11 Right G-H/7-12 Left G-H/7-12 Right

42-5170-004-10, 42-5170-003-03, 42-5170-003-13, 42-5279-003-00, 42-5279-003-01, 42-5279-003-02, 42-5279-003-03, 42-5279-003-04 42-5270-004-10, 42-5270-003-03, 42-5270-003-13, 42-5279-003-00, 42-5279-003-01, 42-5279-003-02, 42-5279-003-03, 42-5279-003-04 42-5170-005-10, 42-5170-005-05, 42-5170-005-15, 42-5279-005-00, 42-5279-005-01, 42-5279-005-02, 42-5279-005-03, 42-5279-005-04 42-5270-005-10, 42-5270-005-05, 42-5270-005-15, 42-5279-005-00, 42-5279-005-01, 42-5279-005-02, 42-5279-005-03, 42-5279-005-04 42-5170-006-10, 42-5170-007-07, 42-5170-007-17, 42-5279-007-00, 42-5279-007-01, 42-5279-007-02, 42-5279-007-03, 42-5279-007-04 42-5270-006-10, 42-5270-007-07, 42-5270-007-17, 42-5279-007-00, 42-5279-007-01, 42-5279-007-02, 42-5279-007-03, 42-5279-007-04

Table 4 - Guidance and manufacturer’s declaration – electromagnetic emissions The VERASENSE and accessories have been tested and found to comply with the electromagnetic compatibility (EMC) limits for medical devices IEC 60601-1-2:2014. Emissions/Immunity Test Compliance Level RF Emissions Class A, Group 1 CISPR 11 Electrostatic discharge (ESD) ± 8 kV contact discharge IEC 61000-4-2 ± 2, 4, 8 & 15kV air discharge 3 V/m Radiated RF Immunity 80 MHz to 2.7 GHz IEC 61000-4-3 80% at 1 kHz Immunity to Proximity Fields from RF wireless communication equipment 28 V/m IEC 61000-4-3 Conducted Immunity 0.15 - 80 MHz IEC 61000-4-6 3 Vrms & 6Vrms in ISM Band 1 kHz, AC Mains Electrical fast transient/burst ± 2 kV AC Mains IEC 61000-4-4 5kHz & 100 kHz Magnetic Immunity 30 A/m IEC 61000-4-8 0% UT .5 cycle Voltage dips, short interruptions and voltage variations on power 0% UT 1 cycle supply input lines 70% UT 25 cycles IEC 61000-4-11 0% UT 5 Sec

LB-5190 Rev. 11 (EN) 11-2021

11 For further information, contact the OrthoSensor Customer Service Center by phone at + 1 954-577-7770 or by e-mail at [email protected] or go to www.orthosensor.com.

Suite A-310 Dania Beach, FL 33004-2200 www.orthosensor.com

FOR REFERENCE ONLY Material: White, 24# Paper, 97 Brightness Measurements: 8.5” x 11” Specs: 4/4 CMYK Double sided print; letters out Trim, staple upper left corner and fold to 5.5” x 8.5” Process Colors:

LB-5190 Rev. 11 (EN) 11-2021

12 For further information, contact the OrthoSensor Customer Service Center by phone at + 1 954-577-7770 or by e-mail at [email protected] or go to www.orthosensor.com.