FCC ID: 2AY5U-A Wireless Charger

Instructions for Use FOR PATIENTS AND HEALTHCARE PROFESSIONALS 1 LB-0009ODF-007-00018-DESREV_03 Welcome to MotionSense Contents Introduction Glossary of terms Your recovery journey System overview Intended use Use environment Warnings Cautions WARNINGS Guide to Parts Ordering new patches 1: Setting up MotionSense 2: Using the MotionSense app 3: Replacing your daily patches 4: Aligning your sensors 5: Replacing weekly skin patches 6: Turning off the sensors 7: Setting up MotionSense 8: Setting sensor alignment 9: Assigning exercises 10: Reviewing recovery progress Troubleshooting Sensor and App Connection Sensor Issues Adhesives Issues Button Functions Safety Information Explanation of Symbols Contraindications Customer Service and Maintenance Customer Service Manufacturer Cleaning and Maintenance Damage and Repair Disposal Technical Specifications Mobile Device Compatibility FCC Declaration FCC Caution RF Exposure Guidance and Manufacturers Declaration Electromagnetic Emissions Technical Data 4 4 4 5 5 5 6 8 6 10 12 14 16 20 24 26 28 30 32 36 38 40 40 41 42 43 43 43 44 45 45 45 45 45 45 46 46 46 47 47 47 48 2 3 LB-0009ODF-007-00018-DESREV_03 Introduction You should use the system to help complete the daily tasks (including, surveys, knee photos and exercises) set by your Care Team. MotionSense is your recovery companion and guides you through exercises following your knee surgery. System overview Data recorded on your sensors is securely sent to your Care Team so they can The MotionSense App will be set up by your Care Team and will guide you monitor your recovery progress remotely. through your recovery program. The MotionSense sensors are applied on the outside of the operative leg, above and below the knee using adhesive patches. These sensors connect to the MotionSense App on your mobile phone. The sensors and app track your knee recovery by measuring the following:

Range of Motion (RoM) Exercise Completion Activities of Daily Living (ADL) - Steps, Active Time Pain Scores Clinical Surveys Glossary of terms Wearable Sensors MotionSense App Care Team App Intended use MotionSense utilizes patient sensors and a mobile app to track, coach, and monitor knee arthroplasty patients remotely. ADL Activities of Daily Living (daily activity including steps and Use environment active time) The MotionSense system is a prescription device in the USA and is intended Care Team (CT) Surgeon OR Physical Therapist OR Healthcare Provider for use in accordance with the directions of a Healthcare Provider. This device Clinical Surveys Patient reported outcome scores appointed by Care Team should be worn throughout the day, including during exercises. Exercise Session A group of exercises to be completed together PT RoM Reps Sets Physical Therapist Range of Motion (the extent of movement from bending to fully extending your leg) Repetitions of an exercise movement Groups of exercise repetitions Your recovery journey Before your surgery, you will be introduced to MotionSense and set up by your Care Team. You will then wear the sensors for at least 7 days to get familiar with the system. After your operation, you will continue to use MotionSense (in collaboration with your Care Team) for up to 90 days. 4 5 LB-0009ODF-007-00018-DESREV_03 Warnings Warnings are statements of special safety alerts to allow you and your Care Team to avoid serious events or serious injury. Always Use Cable and Parts as Directed MotionSense is intended only to be used by adults. Keep all parts and cables away from pets and children to avoid injury from strangulation from cables, avoid choking on parts, and avoid damage to parts that may impact device performance. Always Use Power Plug In Wall Socket Only Do not use power plug with external adapters, extension leads and splitters. Use of any power source other than the wall socket may lead to electrical injury. Do Not Get Power Plug Wet Keep the power plug away from water. Using the power plug near water may lead to electrical injury. Do not use in the event the power plug gets wet. Please dispose of this item safely and contact EnMovi Ltd Customer Services or your Care Team to organise a replacement. Always Use Supplied Charger Always use the wireless charger and power plug supplied by EnMovi Ltd. Using a power supply/plug not included with the sensors may lead to electrical injury. Always Use Power Plug With Cable Pointing Downwards The power plug should be used with the cable outlet pointing downwards. Do not use the power plug and the cable in the wrong orientation. 6 7 LB-0009ODF-007-00018-DESREV_03 Cautions Cautions are statements of special care to be taken by you or your Care Team for the safe and effective use of MotionSense. Set up MotionSense With Your Care Team MotionSense and associated exercise plans must only be set up by a qualified healthcare professional. Any modification of exercise plans by anyone other than a qualified healthcare professional may result in injury and negative impact on your recovery process. Follow Advice of Your Care Team Always complete your exercises and activities of daily living as instructed by Always Use Supplied Patches Always use the weekly skin patches and daily sensor patches supplied to attach the sensors to your leg. If you do not use the supplied patches, the system may not accurately monitor your recovery. Clean Sensors Regularly Clean the sensors as instructed. Not cleaning the sensors increases the chance of infection and can lead to a build up of adhesive which can negatively impact the sensor performance. Do Not Re-Use Patches Do not re-use either the weekly skin patches or the daily sensor patches, as this will lead to poor sensor attachment and may lead to skin irritation. Do Not Use MotionSense If Expired Check the package label for the expiration date and do not use the sensors if the shelf life has expired. Using expired sensors may give incorrect readings. your Care Team. Not doing so could result in pain, injury or have a negative Do Not Share Sensors impact on your recovery progress. Only Allow Trusted Clinicians To Use Your Phone MotionSense requires your Care Team to access your mobile phone to adjust exercises and monitor recovery. Only allow trusted clinicians access to your mobile phone. If someone other than a trusted clinician accesses your mobile phone, personal data may be at risk. Contact Care Team If Your Skin Is Irritated Do not share the sensors with other patients. MotionSense is a prescription-

only medical device. The sensors are designed for your use only. If used by more than one person, the sensors may not monitor as expected. Do Not Service or Modify MotionSense MotionSense does not require servicing and maintenance while in use. Any attempt to perform maintenance or servicing may negatively impact system performance. Contact your Care Team if you experience skin irritation from the patches or sensors. Continuing to use MotionSense in this instance may result in further skin irritation or injury, negatively impacting your recovery progress. Do Not Use the Patch on Your Wound Do not attempt to use the daily or weekly patches on your wound. The patches are not sterile and may lead to an increased risk of infection. Avoid Submerging Your Sensors In Water Do not immerse the sensors in water deeper than 1 meter for more than 30 minutes, this may break or damage the sensors, negatively impact your recovery process. Do Not Bend Sensors Do not intentionally bend or fold the sensors as this may damage them and negatively impact your recovery progress. Do Not Charge Sensors Whilst Wearing Do not try to charge the sensors while they are attached to your body. Trying to do so may result in electrical shock or injury from excessive sensor heat. Do Not Use Physical Assistance During Exercises Do not allow anyone other than a member of your Care Team to physically assist with exercise completion. Seeking physical assistance from anyone other than your Care Team may result in injury or have a negative impact on your recovery progress. 8 9 LB-0009ODF-007-00018-DESREV_03 Guide to Parts This pack contains:

2 Sensors 5 Week supply of patches (weekly skin patches and daily sensor patches) 1 Wireless charger 1 Power Plug and USB Cable 1 Skin Marker You will also need:

Front of charger Wireless Charger The wireless charger is used to charge the sensors at the end of each day. The sensors will fully charge overnight. The USB cable plugs into the Micro USB socket on the back of Back of charger the charger. The MotionSense App (download via the link sent to your mobile phone) 1 Knee Alignment Block Micro USB socket Sensors The sensors monitor how you bend and extend your knee during exercises and daily activity. The upper sensor goes on the outside of your upper leg The lower sensor goes on the outside of your lower leg The sensor ID and PIN are found on the back of each sensor (both sensors have the same ID and PIN) Upper Sensor Status light Power button Upper sensor graphic Lower Sensor Sensor ID and PIN (on rear of sensor) Lower sensor graphic USB Power Plug and USB Cable The power plug connects to the wireless charger via the USB cable. The power plug pins fold out and should be plugged into an electrical outlet for the wireless charger to work correctly. USB socket Micro USB Weekly Skin Patches The weekly skin patches have a white backing and are applied directly to your shaved skin above and below the knee. The weekly skin patches are designed to stay on your leg for 7 days and can be left on while sleeping and showering. Patches are single use. Once removed from the leg, do not reapply. 10 11 LB-0009ODF-007-00018-DESREV_03 Daily Sensor Patches The daily sensor patches have a blue backing and are used to attach the sensors to the Sensor Status Lights When the sensor button is pressed:

weekly skin patches on your leg. They should Solid GREEN: Sensors are working correctly be removed and disposed of each night before charging the sensors. Patches are single use. Once removed from weekly patch or device, do not reapply. MotionSense App The MotionSense App is installed on your mobile phone from the Apple App Store or Google Play Store and connected to your MotionSense App Icon sensors. Solid AMBER: Low battery Check Sensors screen for current battery level Slow AMBER Flash: Sensors not aligned This indicates the sensors were removed from the leg Align your sensors to continue monitoring Go to Align Sensorsand follow the on-screen instructions to complete alignment Fast AMBER Flash: Second sensor is off Check second sensor:

- Press and hold the button for 5 seconds on the second sensor to turn it on

- Check the status light has started flashing amber on the second sensor

- If not, proceed to Sensors are not responsive to button press Skin Marker in Sensor Issues The skin marker is for use when removing the weekly skin patches, to help you replace them correctly. Knee Alignment Block The knee alignment block is for use when aligning the sensors. Always use the supplied knee alignment block when aligning the sensors, to ensure the system remains accurate. Ordering new patches This pack contains enough patches for 1 week before and 4 weeks after surgery. Should you require more patches, please contact your medical practice. Flashing GREEN: Entering standby mode The sensor button has been pressed for 10 seconds and is about to go into standby mode to save power when not in use No Light: No charge If no light after button press, the sensor requires charging. Follow Sensors are not responsive to button press in Sensor Issues Without pressing the sensor button:

Dim GREEN: Sensors are charging Continuous Amber Flash: Sensors are not set up Reconnect sensors to phone:

- Go to the bluetooth settings on your phone and remove the MotionSense sensors from the list of paired devices

- In the More menu of your MotionSense app, select Reconnect Sensors and follow the instructions No Light: Collecting data If the light is off during normal use, the sensors are collecting data 12 13 LB-0009ODF-007-00018-DESREV_03 1: Setting up MotionSense Your Care Team will complete the following steps during your first appointment. Before leaving the healthcare facility, check the following steps are complete. 1d: Applying the daily sensor patches Your Care Team will show you how to attach the daily sensor patches to your sensors. 1a: Installing the MotionSense App 1e: Attaching the sensors Your Care Team will create a patient account for you and help you install the MotionSense App on your mobile phone. The MotionSense App can be downloaded from the iPhone App Store and from the Android Google Play Store, or by following the link sent to your phone. MotionSense App Icon Your Care Team will show you how to attach the sensors to the weekly skin patches on your leg. NOTE: The sensors are stuck to the weekly skin patches using the daily sensor patches. 1b: Connecting the sensors 1f: Aligning the sensors Your Care Team will connect the sensors to your mobile phone. NOTE: The 2x sensors are put into pairing mode by holding both power buttons for 5 seconds, until the status lights flash amber. Your Care Team will show you how to activate and align your sensors using the knee alignment block. 1c: Applying the weekly skin patches 1g: Assign exercises Your Care Team will show you how to attach the weekly skin patches on your leg. They may mark the position on your skin. Your Care Team will assign you daily exercises to complete whilst at home. 14 15 LB-0009ODF-007-00018-DESREV_03 2: Using the MotionSense app The following steps explain how to use the MotionSense App. Caution Do Not Use Physical Assistance During Exercises Do not allow anyone other than a member of your Care Team to physically assist with exercise completion. Seeking physical assistance from anyone other than your Care Team may result in injury or have a negative impact on your recovery progress. 2a: Prepare for your exercise Before completing your exercise check the following:

The sensors are charged Your sensors are correctly attached to your leg The sensors have been aligned

(see section 4) 2b: Exercise overview You will be shown an overview of the exercises in your session. From the Home screen, select Exercise Session. You must complete (or skip as appropriate) all exercises in your session as set by your Care Team. Before you start each exercise, you will see an overview, including information set by your Care Team such as:

Number of sets to complete Number of reps to complete Any notes set by your Care Team Press Start Exercise to begin guidance. 2c: Doing your exercise Follow the in-app instructions to complete your exercise session as set by your Care Team. Depending on the exercise, the screen may also give live exercise feedback on:

Your current knee angle Your target knee angle The hold time The repetition count Caution Do Not Over Exert Yourself During Exercising Follow any instructions your Care Team have given you and do not over-exert your knee. If you feel uncomfortable or unstable, stop and skip your exercise. 16 17 Continued overleaf... LB-0009ODF-007-00018-DESREV_03 2d: (Optional) Skip your exercise 2g: Recovery Progress From the Home screen select Progress in the bottom navigation. You can access progress data for the following:

Range of motion Exercise completion Pain score Step count Active time NOTE: You can select individual bars in week and month view to access the reading for an individual day. It is possible to skip your exercise and save your progress at any time by pressing skip and following the instructions in the app. You will be asked to provide a reason, which will be shared with your Care Team. The exercise will not be accessible again during this session. NOTE: Talk to your Care Team if you have any questions about your exercise. 2e: (Optional) Exit your exercise You can exit your exercise and save progress by pressing X. This will close your current session and it will be marked as incomplete. You will be asked for the reason, which will be shared with your Care Team. 2f: Complete your exercise Upon completing your exercise, recover before starting the next one. When ready, press Start to begin. If you have completed your final exercise of this session, you will return to the Home screen. 18 19 LB-0009ODF-007-00018-DESREV_03 3: Replacing daily sensor patches You should replace your daily sensor patches each day. You should remove both your sensors each evening and charge them overnight on the wireless charger. Each evening, follow steps 3a-3e to remove the sensors and patches Each morning, follow steps 3f-3l to re-attach the daily sensor patches and sensors 3a: Remove the sensors from your leg Every evening:

Take care not to remove the weekly skin patches and follow these steps to remove both sensors:

Press the edge of the weekly skin patch against your leg At the same time, slowly peel the sensors away from your leg NOTE: Its easiest to remove the sensor by peeling it off side-ways as shown. 3c: (Optional) Clean the sensors Some residue build up is normal. If necessary, you can use an alcohol wipe to remove the residue. These are available from your local pharmacy. NOTE: If excess residue is causing you an issue using your sensors, contact your Care Team. 3d: Set up the wireless charger Complete the following steps to set up the wireless charger:

Plug the large end of the USB cable into the USB socket on the bottom of the power plug Unfold the pins on the back of the power plug Plug the power plug into a wall socket making sure the cable points downwards Plug the small end of the USB cable into the USB socket on the back of the wireless charger

(see guide to parts for USB socket location) Warning Always Use Power Plug With Cable Pointing Downwards The power plug should be used with the cable outlet pointing downwards. Do not use the power plug and the cable in the wrong orientation. See Warnings, page 6. 3b: Remove the daily sensor patches 3e: Charge the sensors overnight Use the white release tab to remove the daily sensor patches from the back of the sensors, and dispose of them in a bin. Place both sensors upright on the wireless charger to charge them overnight. CHECK: Make sure the sensor status light is a dim green, showing the sensors are charging. 20 21 Continued overleaf... LB-0009ODF-007-00018-DESREV_03 3f: Check your sensors Each morning:

Remove the sensors from the wireless charger and check the status by pressing the power button for 1 second. A solid green light means the sensor is charged. 3j: Check the sensor orientation Make sure the sensor is upright, with the power button at the top as shown. CHECK: Make sure the weekly skin patches on your leg are clean and dry. If they are not, the sensors may not attach correctly. 3g: Prepare a new daily sensor patch 3k: Place upper sensor on the weekly skin patch Get a new daily sensor patch ready by peeling away and disposing of the blue backing material. NOTE: The daily patch should stay attached to the clear backing material. 3h: Apply the daily sensor patch CHECK: Make sure the sensor is clean and dry. Then stick the patch centrally on the back of the upper sensor. Stick the upper sensor upright on top of the weekly skin patch on your upper leg. Take care to position the sensor centrally on the weekly skin patch with the button facing upward as shown. Press the sensor against the leg for 3 seconds. Caution Do Not Reapply Used Daily Patches Always use a new daily patch, even if they fall off during the day. Never reuse patches as the sensors may not stick properly, negatively impacting system performance. 3i: Remove remaining backing material 3l: Repeat for the lower sensor With the patch stuck on the sensor, remove and dispose of the remaining clear backing material. NOTE: Avoid touching the adhesive before attaching to your leg, as sensors may not stick properly. 22 Repeat steps 3f-3k to fit the lower sensor to the weekly skin patch on your lower leg. NOTE: You must now complete the steps in section 4: Aligning your sensors before you do your exercises. 23 LB-0009ODF-007-00018-DESREV_03 4: Aligning your sensors The following steps explain how to align your sensors in a repeatable position using the knee alignment block supplied. The sensors need to be aligned each morning, if they fall off your leg during the day or if required by the app. This helps to ensure the sensors remain accurate. Caution Do Not Complete Alignment If You Feel Unstable Check you are able to enter and exit the alignment pose safely using a walker or chair for support. Instability during the alignment process may result in injury. Stop and contact your Care Team if you feel unstable. 4a: Check attachment Check your sensors are correctly positioned:

The upper sensor should be on the upper leg The lower sensor should be on the lower leg Both sensors should be upright, with the button at the top NOTE: You can tell the difference between the upper and lower sensors by looking at the graphic on each device:

4b: Get into position Place the supplied knee alignment block flat on the floor, in a clear space. Then, following the instructions in the app:

Find a clear space, free from obstructions and position a walker or chair in front of you to help you balance Step operated leg onto block using a walker or chair infront of you to aid balance (as shown) Line up both feet at hip distance apart making sure your foot is in the foot outline, and your toes are in line with each other 4c: Enter the alignment pose Continue following the instructions in app:

Relax and make sure your hips are level and not tilted (as shown) Hold this position for 3 seconds Once the countdown is complete, press Update Alignment Follow the on-screen prompts to check the sensor measurement. If the app angle visually matches your actual knee angle then select Confirm Alignment Carefully get out of position to go about your day Upper Sensor Lower Sensor Caution Remain Still During Alignment Ensure you do not move once in the alignment position as this can lead to incorrect sensor readings. If you move your leg during alignment you will receive a prompt to restart. 24 25 LB-0009ODF-007-00018-DESREV_03 Page 27 5: Replacing weekly skin patches 5d: Prepare the attachment area You should replace your weekly skin patches every 7 days. 5a: Remove your sensors In the evening:

Follow steps 3a-3d to remove both your sensors and charge them overnight. Page 27 The following morning:

Prepare the skin by:

Removing any hair in the attachment area Cleaning the attachment area with warm soapy water and a damp cloth. Make sure not to remove the pen markings NOTE: Some residue build up is normal but if you are having difficulty attaching the weekly patches to your leg, contact your Care Team. 5b: Mark the location of the old patches 5e: Check the attachment area Page 26 Use the skin marker provided to mark the location of the old weekly skin patches on your skin. Draw around the top and bottom curve of the patch to help ensure the newly applied patch is placed in the same place. CHECK: Make sure the attachment area is clean, dry and free of any oils. 5c: Remove the old weekly skin patches 5f: Prepare a new weekly skin patch Page 27 Press down on the skin outside of the weekly skin patch and gently lift an edge. Remove the weekly skin patch and dispose in a bin. Repeat for both patches. You will fit your new weekly skin patches the following morning. Then, remove and dispose of the backing material from the back of the weekly skin patch. 26 27 Continued overleaf... LB-0009ODF-007-00018-DESREV_03 6: Turning off the sensors You should turn off your sensors if they will not be worn for more than a day. 6a: Press and hold the button Press and hold the power button on the sensor until the status light starts flashing green, then let go. The sensors are now in standby mode Repeat for the other sensor Store the sensors on the wireless charger 5g: Apply the first patch Align the new weekly skin patch with the two lines marked on your skin and smooth down the edges. Then place your hand on top of the weekly skin patch and hold for 10 seconds. This will enhance the adhesion of the patch. Alternatively, without skin markings Align the weekly skin patch along the outside of the upper leg, at least a hands width distance away from the joint center as shown Position the patch along the joint center line as shown Place your hand on top of the weekly skin patch and hold for 10 seconds 5h: Repeat for the second patch Repeat steps 5d-5g to attach the second weekly skin patch to your lower leg. Now follow steps 3f-3k to attach your sensors. 28 29 LB-0009ODF-007-00018-DESREV_03 7: Setting up MotionSense FOR HEALTHCARE PROFESSIONALS ONLY You should help your patient to set up MotionSense and ensure they are comfortable and able to use the system safely at home with the following steps. 7a: Register patient and enable MotionSense Register your patient in OrthoLogIQ (OIQ) by:

Adding new patient information Adding new case details Enabling MotionSense for the patient Once registration is complete, an email and sms Page 31 will be sent to the patient. 7c: Apply the weekly skin patches Once registered, the app will prompt the patient to wear their sensors. You should help the patient by doing the following:

Explain that the weekly skin patches attach to the leg, and the daily sensor patches are applied to the sensors Shaving any hair in the sensor attachment area Follow steps 5d-5g to attach the weekly skin patches to the affected leg, at least a hands width distance away from the joint center as shown Mark the location of the applied patches with the skin marker included Explain that the weekly skin patches must be replaced every week 7b: Install app and connect sensors 7d: Apply the daily sensor patches and sensors When introducing the patient to MotionSense, you should help them set up with the following steps:

Download the MotionSense App from the iOS or Android App Store, or follow the link sent to the patients mobile phone Open the app, select Set up your account and follow the instructions in the app to create an account for the patient Login to the Care Team Mode using your OIQ account details Connect the sensors. You will need to enter the Sensor ID and PIN during the connection Sensor ID PIN process Follow steps 3f-3k to apply the daily sensor patches and attach the sensors. Explain that the sensors must be removed every evening, charged overnight and re-attached every morning as shown in Section 3 30 31 Continued overleaf... LB-0009ODF-007-00018-DESREV_03 8: Setting sensor alignment FOR HEALTHCARE PROFESSIONALS ONLY The following steps explain how to set sensor alignment using the knee alignment block supplied. You will be prompted to Practice Alignment and Set Sensor Alignment as part of patient onboarding in the app. You might need to repeat the alignment process with the patient periodically during recovery if measurement issues arise. Caution Check Patient Is Stable When Completing Alignment Check the patient is able to enter and exit the alignment pose safely using a walker or chair for support. Instability during the alignment process may result in injury. 8a: Practice alignment position Log in to the Care Team Mode in the app and select Set Sensor Alignment. Find a clear space, free from obstructions and position a walker or chair in front of the patient to help them balance x3 Place the supplied knee alignment block flat on the floor, in a clear space Following the instructions in the app, it is recommended you practice 3 times with your patient to ensure they can achieve a relaxed, repeatable position on the alignment block at home (see steps 4a - 4c) Once you have completed alignment practices with your patient, select Final Alignment 32 8b: Get into final alignment position Then, following the instructions in the app:

Step operated leg onto block using a walker or chair infront of the patient to aid balance Line up both feet at hip distance apart making sure the patients foot is in the foot outline, and their toes are in line with each other Caution Remain Still During Alignment Ensure the patient does not move their legs once in the alignment position as this can lead to incorrect sensor readings. If the patient moves their leg during alignment you will recieve a prompt to restart. 8c: Enter the alignment pose Continue following the instructions in the app, helping the patient to:

Relax and make sure their hips are level and not tilted (as shown) Instruct the patient to hold this position for 3 seconds 33 LB-0009ODF-007-00018-DESREV_03 8d: Measure knee flexion Ensure the patient remains in the same position and does not move their legs. Then:

Use a goniometer to measure the knee angle of the patients affected leg 8e: Enter and confirm the knee flexion angle Following the instructions in the app:

Ensure the patient remains still then enter the knee flexion angle and select Set Angle Follow the on-screen prompts to check the sensor measurement. If the app angle visually matches the actual knee angle then select Confirm Alignment The alignment process is now complete. Ask the patient to return to a normal standing position. 34 35 Continued overleaf... LB-0009ODF-007-00018-DESREV_03 9: Assigning exercises FOR HEALTHCARE PROFESSIONALS ONLY The following steps explain how to assign a list of exercises to your patient. 9a: Setting an exercise plan At the end of onboarding you will be prompted to select one of the following two ways of allocating exercises:

Allocate Default Plan - This applies an initial list of exercises that can be adjusted Set Manually - This allows you to manually select your own list of exercises You can also allocate exercises by logging in to the Care Team Mode and selecting Exercise Plan. 9c: Edit exercises You can edit an exercise by selecting Edit on your selected exercises. You can then adjust the details of the exercise and save by selecting Save Changes. Adjust the following according to your patients capability:

Number of sets Number of reps Start angle Target angle Hold time Resistance weight You can also add PT notes to guide your patient. Caution Angles entered here will be displayed back to the patient as 5 easier targets to achieve. This allows for any offset in sensor readings. 9b: Select exercises 9d: Save to patient profile You can allocate either 1 or 2 sessions to be completed daily by your patient. You can then add an exercise to your selected exercises by selecting the checkbox. NOTE: If you select 2 sessions, each session will display the same exercises. Once you have finished adjusting your exercises, save by selecting Save to Profile. 36 37 LB-0009ODF-007-00018-DESREV_03 10: Reviewing recovery progress FOR HEALTHCARE PROFESSIONALS ONLY The following steps explain how to access and review your patients recovery progress. 10a: Recovery Progress You can access recovery progress by logging in to the Care Team Mode and selecting Progress. Alternatively, you can review this data in OIQ. You can access progress data for the following:

Range of motion Exercise completion Pain score Step count Active time NOTE: You can select individual bars in week and month view to access the reading for an individual day. 38 39 LB-0009ODF-007-00018-DESREV_03 Troubleshooting Sensor and App Connection What to do if Solution Sensors and app are Sensors are not aligned correctly, repeat the working but the angle align sensors process to continue monitoring reading seems wrong Read section 4 of the MotionSense Instructions for Use and repeat the Align Sensors process, following the on-screen instructions to complete alignment Sensor Light is green Turn on Bluetooth on your phone:

but the phone cannot

- Check the phone Bluetooth is ON connect

- If the problem persists then see Sensors do not behave as expected to perform a sensor reset App cannot detect the Go to the Bluetooth settings on your phone sensor and remove the MotionSense sensors from the list of paired devices In the About and Settings menu of your MotionSense app, select Reconnect Sensors and follow the instructions Sensor Issues What to do if Solution Sensors are not responsive to button press The sensor battery is empty. Charge the sensors:

- Ensure charger cradle is plugged in

- Place sensors on charger

- Check sensor light is dim green Sensors are not Ensure wall adapter is plugged into socket charging Ensure charger cable is plugged into the wall adapter and the back of the charging cradle Check both sensors are in the charging cradle the correct way up (with the button and light at the top) and the correct orientation (with the flat surface touching the charger) Ensure both sensors are sitting properly in the charger and not sitting away from the cradle You should see a green dim light on both sensors during charging Sensors do not behave Your sensors need to be reset:

as expected

- Press and hold both sensor buttons for 30 seconds

- Release the button and press again for 3 seconds

- The sensor light should now flash amber continuously on both devices

- Go to the bluetooth settings on your phone and remove the MotionSense sensors from the list of paired devices

- In the About and Settings menu of your MotionSense app, select Reconnect Sensors and follow the instructions 40 41 LB-0009ODF-007-00018-DESREV_03 Adhesives Issues Button Functions What to do if Solution Function Button Action Sensors and daily Your daily patch needs to be replaced following Status Check Tap the sensor button. sensor patch steps in section 3 in the MotionSense repeatedly falling off Instructions for Use:

leg

- Remove the sensors from the leg

- Remove the daily sensor patches

- Prepare and apply a new daily sensor patch to the sensors

- Remove the remaining backing material

- Check orientation and place sensors on the weekly patch Turn On Press and hold the sensor button for 5 seconds until you see the sensor light flash amber and then let go. Turn Off Press and hold the sensor button for 10 seconds until you see the sensor light flash green then let go. Weekly skin patch Your weekly patch needs to be replaced repeatedly falling off following the steps in section 5 of the leg MotionSense Instructions for Use:

Safety Information Explanation of symbols used on labels

- Remove your sensor

- Mark the location of the old patch

- Shave and clean the attachment area

- Prepare and attach a new weekly patch with two lines marked on your skin

- Replace the daily sensor patch following steps in section 3 of the MotionSense Instructions for Use 42 Manufacturer Temperature limit Keep away from direct sunlight Keep dry Refer to Instructions for Use Icon appears inverted in white on sensors Type BF applied part Non sterile 43 LB-0009ODF-007-00018-DESREV_03 Date of manufacture Do not re-use Humidity limitation Use by date Catalog number Batch code Class II equipment Protection against the effects of temporary immersion in water Protection against solid foreign objects of 12.5 mm and greater in diameter and protection against vertically falling water drops Hazard warning Contraindications Customer Service and Maintenance Customer Service

(+1) 800.354.1231 support@enmovi.com Manufacturer EnMovi Ltd. Unit 1l, Inovo Building, 121 George St, Glasgow G1 1RD, United Kingdom Cleaning and Maintenance Use a new daily sensor patch for each application of the sensor to the bigger weekly skin patch. To clean the sensors, you can use an alcohol wipe. These are available from your local pharmacy. Use a new weekly skin patch every 7 days or when the adhesive starts peeling off or becomes dirty or grimy. To clean the skin use warm soapy water to remove any adhesive residue before application of a new weekly skin patch. Damage and Repair MotionSense does not have any user or patient serviceable parts inside. If the device appears damaged or to be defective, stop using the device immediately and contact Customer Service. Do not attempt to repair or modify MotionSense products on your own. Absolute contraindications to the use of the MotionSense system include Disposal lower limb skin conditions such as psoriasis and excessive scarring, physical Dispose of the patches in your household waste bin. and mental conditions that prohibit appropriate rehabilitation, and morbid obesity. Relative contraindications include active knee sepsis, previously untreated or chronic osteomyelitis, ongoing remote source of infection. Dispose of the sensors in accordance with local guidelines. If you need to remove the battery for disposal, use scissors to carefully cut down the soft plastic in the middle of the sensors and pull out the battery. Do not cut through the battery. 44 45 LB-0009ODF-007-00018-DESREV_03 Technical Specifications Mobile Device Compatibility Android Running 8.0 and up Apple iPhone running iOS 11.0 and up Phone hardware must support BLE 4.2 Communication protocol FCC Declaration This device complies with Part 15 rules. Operation is subject to the following two conditions:

This device may not cause harmful interference, and This device must accept any interference received, including interference that may cause undesired operation This equipment has been tested and found to comply with the limits of a Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference FCC Caution Changes or modifications not expressly approved by the party responsible for compliance could void the users authority to operate the equipment. RF Exposure The wireless charger unit complies with FCC radiation exposure limits set forth for an uncontrolled environment and meets the FCC radio frequency (RF) Exposure Guidelines. This wireless charger should be installed and operated keeping it at least 20cm or more away from persons body. Guidance and Manufacturers Declaration Electromagnetic Emissions MotionSense has 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 when the equipment is operated in a residential environment. This equipment RF Emissions CISPR 11 Class B, Group 1 generates, uses, and radiates radio frequency energy, and if not installed and used in accordance with the instructions, may cause harmful Harmonic Current Emission Applicable, Class A interference. However, there is no guarantee that interference will not occur. IEC 61000-3-2 If this equipment does cause interference to radio or television reception, which can be determined by turning the equipment off and on, the user is Voltage change, Voltage Applicable encouraged to correct the interference by one of the following measures:

fluctuations and Flicker Emission Reorient or relocate the receiving antenna. IEC 61000-3-3 Increase the separation between the equipment and receiver. Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. Consult the dealer or an experienced radio/TV technician for help. To which this declaration relates, is in conformity with the following standard:

EMC FCC Part 15 (B) Class B Radio 47 CFR Part 15.247 Contains FCC ID: HSW2832 for wareable sensor Conducted Immunity Applicable, 3 Vrms, 6 Vrms ISM Bands IEC 61000-4-6 and amateur radio Bands Immunity to Proximity Fields 80 MHz to 2.7 GHz, 10 V/m from RF wireless communication equipment IEC 61000-4-3 Electrostatic discharge (ESD) 8 kV Contact, 15 kV Air Radio 47 CFR Part 15 FCC ID: 2AY5U-A for wireless charger IEC 61000-4-2 46 47 LB-0009ODF-007-00018-DESREV_03 Emissions/Immunity Test Compliance Level Battery Li-ion 140mAh x 2 Electrical fast transient/burst Applicable IEC 61000-4-4 Surge Immunity IEC 61000-4-5 Applicable Voltage dips, short interruptions Applicable and voltage variations on power 30 A/m supply input lines IEC 61000-4-11 Magnetic Immunity IEC 61000-4-8 Technical Data Product Digital Goniometer description Brand EnMovi Ltd. Model MotionSense Model Sensor: MS 2.0 Charger: MSC 2.0 Resolution 1 of knee angle and 5 of RoM2 Operational

+5C to +40C (+41F to +104F) conditions RH greater than 15% up to 95%

70 kPa - 106 kPa minimum of 24 hours of operation Wireless Charger 5V DC and 1A Input power, charging power < 5W AC DC power ODF-007-00053 supply3 Size Sensor: L = 85mm (3.34 in.) x W = 35mm (1.38 in.) x H = 8mm (0.31 in.) Charger: L = 45mm (1.71 in.) x W = 78mm (3.08 in.) x H = 69mm (2.70 in.) Weight Wearable each less than 15g Charger less than 200g Water Sensor IPX7 Resistance Wireless Charger IP21 Package contents Wearable Contains FCC ID Charger FCC ID 2 Sensors 1 Wireless charger, cable and power plug 5 Week supply of patches (weekly skin patches, daily sensor patches) 1 Skin Marker FCC ID Frequency Modulation EIRP Band HSW2832 2402-2480MHz GFSK 1.216mW FCC ID Frequency Modulation Band 2AY5U-A 1.047MHz N/A Transport

-25C to +5C (-13F to +41F) for 72 hours, and and Storage

+5C to +35C (+41F to +95F) RH up to 85% for 72 hours, between uses

+35C to +60C (+95F to +140F) for 6 hours Product life 4 months Shelf life 24 months 48 49 LB-0009ODF-007-00018-DESREV_03 NOTE:

1. Specifications are subject to change without prior notice or any obligations on the part of the manufacturer. 2. Clinical Accuracy characteristics and procedures are available from the manufacturer on request. 3. Supply adapter plug serves as the mains disconnect device. MotionSense is a registered trademark of EnMovi Ltd. SDoC Information Unique Identifier: MSC 2.0 Responsible Party U.S. Contact Information

- Company : OrthoSensor, Inc.

- Contact person : Deborah Johnson

- Address : Florida, Dania Beach 1855 Griffin Rd STE A310

- Phone: +1 954 686 5235 / E-Mail: deborah.johnson@stryker.com Notes 50 51 LB-0009ODF-007-00018-DESREV_03 52

Label and Location FCC ID: 2AY5U-A Label Location

* This lable is attached to the front of the product and not easily removed.

enmovi =

CONFIDENTIALITY REQUEST Federal Communication Commission Equipment Authorization Division, Application Processing Branch 7435 Oakland Mills Road Columbia, MD 21048 2021.03.15 TO WHOM IT MAY CONCERN Pursuant to Paragraphs 0.457 and 0.459 of the Commissions Rules (47 C.F.R.) and Section 552(b)(4) of the Freedom of Information Act, EnMovi Ltd requests confidentiality for the following products:

FCC ID Number Product Title/Model ZAY5U-A Wireless Charger / MSC 2.0 The following exhibits contain trade secrets and proprietary information that could be of benefit to our competitors regarding the design of our product. This material is not customarily available to the general public and we request that it be withheld from public inspection. We request that the following information submitted be held permanent confidential treatment. Permanent Confidential Request

- Schematics

- Block diagram

- Part List

- Operational description We request that the following information submitted be held short-term confidential treatment for 180 days. Short- term Confidential Request

- Internal photo

- Set Up Photo

- External Photo

- Manual If you have any questions, please feel free to contact me at the address shown below. Best regards, Chong Solretae. Name: Allana Johnstone Title: Director of Quality and Regulatory Affairs Company name: EnMovi Ltd

Date: 15th of March, 2021 Federal Communications Commission 7435 Oakland Mills Road Columbia MD 21046 CX. UL Verification Services Inc. (formerly UL CCS) Certification Division 47173 Benicia Street Fremont, CA 94538, USA To whom it may concern:

I, the undersigned, hereby authorize UL-Korea and hereafter referred to as ULK, to act on our behalf in all manners relating to application for equipment authorization, including signing of all documents relating to these matters. Any and all acts carried out by UL-Korea on our behalf shall have the same effect as acts of our own. I, the undersigned, hereby certify that we are not subject to a denial of federal benefits, that includes FCC benefits, pursuant to Section 5301 of the Anti-Drug Abuse Act of 1988, 21 U.S.C. 853(a). In authorizing ULK as our agent, we still recognize that we are responsible to:

a) comply with the relevant provisions of the certification program;

b) make all necessary arrangements for the conduct of the evaluation, including provision for examining documentation and access to all areas, records (including internal audit reports) and personnel for the purposes of evaluation (e.g. testing, inspection, assessment, surveillance, reassessment) and resolution of complaints;

c) make claims regarding certification only in respect of the scope for which certification has been granted;

d) do not use our product certification in such a manner as to bring the Certification Division into disrepute and not make any statement regarding our product certification which the Certification Division may consider misleading or unauthorized;

e) upon suspension or cancellation of certification, discontinue use of all advertising matter that contains any reference thereto and return any certification documents as required by the Certification Division;

f) use certification only to indicate the products are certified as being in conformity with specified standards;

g) endeavor to ensure that no certificate or report nor any part thereof is used in a misleading manner;

h) ensure that any reference to our product certification in communication media such as documents, brochures or advertising, complies with the requirements of the Certification Division;

i) keep a record of all complaints made known to the us relating to the products compliance with requirements of the relevant standard and to make these records available to the Certification Division when requested;

i) take appropriate action with respect to such complaints and any deficiencies found in products or services that affect compliance with the requirements for certification;

k) document the actions taken. This authorization is valid until further written notice from the applicant. Sincerely Yours, Quon eldee:

Type Name: Allana Johnstone Title: Director of Quality and Regulatory Affairs E-mail: Allana.johnstone@enmovi.com Company name: EnMovi Ltd REMARK:

1. This authorization letter will be sent along with your application when filing with the Certification Division. De Please follow the format and type it on company letterhead and send original to us. 3. Authorized signature must be in agreement with grantee code contact in FCC database.