Instructions for Use ODF-007-00018-DES LB-0009 REV_03 FOR PATIENTS AND HEALTHCARE PROFESSIONALS 1
8: Setting sensor alignment 32 9: Assigning exercises 36 10: Reviewing recovery progress 38 Troubleshooting 40 Introduction 4 Glossary of terms 4 Your recovery journey 4 System overview 5 Intended use 5 Use environment 5 Warnings 6 40 Sensor Issues 41 Adhesives Issues 42 Button Functions 43 Safety Information 43 Explanation of Symbols 43 Contraindications 44 Customer Service and Maintenance 45 Cautions 8 Customer Service 45 WARNINGS 6 Manufacturer
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. The MotionSense® App will be set up by your Care Team and will guide you System overview Data recorded on your sensors is securely sent to your Care Team so they can monitor your recovery progress remotely. through your recovery program.
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.
Cautions Always Use Supplied Patches Cautions are statements of special care to be taken by you or your Care Team for the safe and effective use of MotionSense®. system may not accurately monitor your recovery. 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 MotionSense® and associated exercise plans must only be set up by a qualified healthcare professional.
Guide to Parts Wireless Charger Front of charger The wireless charger is used to This pack contains: charge the sensors at the end of each day. The sensors will fully charge overnight. • 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 The USB cable plugs into the Micro USB socket on the back of the charger.
Daily Sensor Patches The daily sensor patches have a blue backing and are used to attach the sensors to the weekly skin patches on your leg. They should Sensor Status Lights When the sensor button is pressed: Solid GREEN: Sensors are working correctly be removed and disposed of each night before charging the sensors. Patches are Solid AMBER: Low battery single use. Once removed from weekly patch • Check ‘Sensors’ screen for current battery level or device, do not reapply.
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. 1a: Installing the MotionSense® App 1d: Applying the daily sensor patches Your Care Team will show you how to attach the daily sensor patches to your sensors.
2: Using the MotionSense® app 2b: Exercise overview You will be shown an overview of the exercises The following steps explain how to use the MotionSense® App. in your session. From the Home screen, select ‘Exercise Session’. You must complete (or skip as appropriate) all Caution exercises in your session as set by your Care Team.
2d: (Optional) Skip your exercise 2g: Recovery Progress It is possible to skip your exercise and save From the Home screen select ‘Progress’ in the your progress at any time by pressing ‘skip’ and bottom navigation. following the instructions in the app. You can access progress data for the following: You will be asked to provide a reason, which will • Range of motion be shared with your Care Team. The exercise will • Exercise completion not be accessible again during this session.
3: Replacing daily sensor patches 3c: (Optional) Clean the sensors Some residue build up is normal. If necessary, you You should replace your daily sensor patches each day. can use an alcohol wipe to remove the residue. These are available from your local pharmacy. You should remove both your sensors each evening and charge them overnight on the wireless charger.
3f: Check your sensors 3j: Check the sensor orientation Make sure the sensor is upright, with the power Each morning: button at the top as shown. Remove the sensors from the wireless charger and check the status by pressing the power CHECK: Make sure the weekly skin patches on button for 1 second. A solid green light means your leg are clean and dry. If they are not, the the sensor is charged. sensors may not attach correctly.
4: Aligning your sensors 4b: Get into position Place the supplied knee alignment block flat on The following steps explain how to align your sensors in a repeatable position using the knee alignment block supplied. the floor, in a clear space. Then, following the instructions in the app: 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.
5: Replacing weekly skin patches 5d: Prepare the attachment area The following morning: You should replace your weekly skin patches every 7 days. 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 5a: Remove your sensors NOTE: Some residue build up is normal but if In the evening: you are having difficulty attaching the weekly patches to your leg, contact your Care Team.
5g: Apply the first patch Align the new weekly skin patch with the two lines marked on your skin and smooth down the edges. 6: Turning off the sensors You should turn off your sensors if they will not be worn for more than a day. Then place your hand on top of the weekly skin patch and hold for 10 seconds. This will enhance the adhesion of the patch.
7: Setting up MotionSense® 7c: Apply the weekly skin patches Once registered, the app will prompt the patient FOR HEALTHCARE PROFESSIONALS ONLY to wear their sensors. You should help the You should help your patient to set up MotionSense® and ensure they are • patient by doing the following: comfortable and able to use the system safely at home with the following steps.
8: Setting sensor alignment 8b: Get into final alignment position Then, following the instructions in the app: FOR HEALTHCARE PROFESSIONALS ONLY • The following steps explain how to set sensor alignment using the knee alignment block supplied.
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 patient’s 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.
9: Assigning exercises 9c: Edit exercises You can edit an exercise by selecting ‘Edit’ on FOR HEALTHCARE PROFESSIONALS ONLY your selected exercises. You can then adjust the details of the exercise and save by selecting The following steps explain how to assign a list of exercises to your patient. ‘Save Changes’.
10: Reviewing recovery progress FOR HEALTHCARE PROFESSIONALS ONLY The following steps explain how to access and review your patient’s 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.
Sensor Issues Troubleshooting Sensor and App Connection What to do if… Solution Sensors and app are • working but the angle • Solution Sensors are • The sensor battery is empty.
Adhesives Issues Button Functions What to do if… Solution Function Button Action Sensors and daily • Status Check Tap the sensor button. Turn On Press and hold the sensor button for 5 seconds Your daily patch needs to be replaced following sensor patch steps in section 3 in the MotionSense® repeatedly falling off Instructions for Use: leg - Remove the sensors from the leg until you see the sensor light flash amber and then - Remove the daily sensor patches let go.
Date of manufacture Customer Service and Maintenance Do not re-use Customer Service (+1) 800.354.1231 Humidity limitation Use by date support@enmovi.com Manufacturer EnMovi Ltd. Unit 1l, Inovo Building, 121 George St, Glasgow G1 1RD, United Kingdom Catalog number Cleaning and Maintenance Batch code Use a new daily sensor patch for each application of the sensor to the bigger weekly skin patch.
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 Caution Changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment.
Emissions/Immunity Test Compliance Level Electrical fast transient/burst Applicable IEC 61000-4-4 Battery minimum of 24 hours of operation Wireless Applicable Surge Immunity IEC 61000-4-5 Applicable and voltage variations on power 5V DC and 1A Input power, charging power < 5W Charger AC DC power Voltage dips, short interruptions Li-ion 140mAh x 2 ODF-007-00053 supply3 Size Sensor: L = 85mm (3.34 in.) x W = 35mm (1.38 in.) supply input lines x H = 8mm (0.31 in.
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.
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