CyMedica Orthopedics® e-vive™ NMES USER’S MANUAL Read this manual carefully before operating the e-vive™ NMES System Customer Service 1-844-CYM-2014 www.cymedicaortho.com Please log onto www.cymedicaortho.com for instructional videos related to the proper use of e-vive™ system. CY-0090-018 Rev. A 2/2020 CY-0090-018, Rev.
Contents 1 INTRODUCTION ............................................................................ 4 2 INTENDED USE ............................................................................. 4 3 SAFETY INFORMATION ................................................................. 6 3.1 EXPLANATION OF SYMBOLS ..................................................... 6 3.2 DEFINITIONS ............................................................................. 8 3.3 CONTRAINDICATION ........................
8.2 8.3 8.4 8.5 8.6 8.7 8.8 8.9 Repair...................................................................................... 34 Cleaning and Maintenance ..................................................... 34 Operating Conditions.............................................................. 35 Transportation and Storage Conditions ................................. 35 Shelf Life or Use By Date Information .................................... 35 Expected Service Life and Disposal Information ...............
1 INTRODUCTION The CyMedica Orthopedics e-vive™ system with CyMotion® technology is an electrotherapy device providing neuromuscular electrical stimulation (NMES). The e-vive™ system is a prescription device in the USA and is intended for use under the direction of a medical provider. The device may be used in a health care facility setting or by a patient at home. The e-vive™ closed loop system provides strong yet comfortable muscle activation.
Indications for Use: As an NMES device, indications are for the following conditions: Relaxation of muscle spasms Retardation or prevention of disuse atrophy Increasing local blood circulation Re-educating muscles Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis Maintaining or increasing range of motion Use environment The e-vive™ system is a prescription device in the USA and is intended for use in accordance with the directions of a health care provider.
3 SAFETY INFORMATION 3. 1 E X PL A N A T ION O F SY M B OL S The following symbols are used in this user’s manual, and on the device packaging, or on the device or accessory labeling. Symbol Description Reference number; part number Lot number Serial Number Manufacturing date Legal Manufacturer name and address Follow instructions for use Expiration date ISO 15223-1:2012(E) 5.1.3 ISO 15223-1:2012(E) 5.1.1 ISO 7010:2011-M002 Minimum and maximum operating range temperature range ISO 15223-1:2012(E) 5.1.
Temperature Limitation ISO 7000:2014-0632 Pressure Limitation ISO 7000:2014-2621 Keep the device away from sunlight ISO 15223-1:2012(E) 5.3.2 ISO 15223-1:2012(E) 5.3.4 Keep the device dry Do not iron device ISO 7000:2014-3113 Do not machine wash device ISO 7000:2014-3123 Do not use bleach to clean device ISO 7000:2014-3124 Do not tumble dry device ISO 7000:2014-3109 Do not dry clean ISO 7000:2014-3114 CE Marking Medical Device Directive 93/42/EEC ISO 15223-1:2012(E) 5.1.
IP02 Protection against vertically falling water drops when enclosure tilted up to 15° Protection against medium-sized foreign bodies with a diameter > 12 mm; Protection against vertically falling water drops when enclosure tilted up to 15° Type BF applied parts IP22 Lead wires comply with the performance standard for electrode lead wires (21 CFR part 898) Product contains electrical and electronic equipment.
3. 3 C ON TR A IN DI C AT IO N Powered muscle stimulators should not be used on patients with cardiac demand pacemakers. 3. 4 W AR N IN G S 1. The long-term effects of chronic electrical stimulation are unknown. 2. Stimulation should not be applied over the carotid sinus nerves, particularly in patients with a known sensitivity to the carotid sinus reflex. 3. Stimulation should not be applied over the neck or mouth.
13. Do not service or perform any maintenance on device while in use. 14. Do not apply the treatment continuously more than one full cycle at a time (20 minutes for NMES treatment). Allow a minimum of three hours rest in between each treatment. 3. 5 PRE C A U T I ON S 1. Safety of powered muscle stimulators for use during pregnancy has not been established. 2. Caution should be used for patients with suspected or diagnosed heart problems. 3.
. 12. 13. 14. 15. 16. 17. 18. 19. 20. 21. 22. 23. 24. 2/2020 the electrodes in such a way that their entire surface is in contact with the skin. Use of electrodes with an active area less than 16 cm2 will risk suffering a burn injury. Caution should always be exercised with current densities more than 2 mA/cm2. Do not wrap electrode lead wires around your neck and keep them out of the reach of children. Strangulation may result from entanglement in the electrode lead wires.
unwanted activation of your e-vive™ system. Avoid them if possible. a. Antennas of citizen band (CB) or ham radios. b. Electric arc welding equipment. c. Electric induction heaters. d. Electric steel furnaces. e. High-voltage areas (safe if outside the fenced area). f. Large stereo speakers. g. Magnets or other equipment that generate strong magnetic fields. h. Microwave communication transmitters (safe if outside the fenced area). i. Power lines or power generators. j.
3. 6 A D VE RSE RE AC T I ON S 4 Skin irritation and burns beneath the electrodes have been reported with the use of powered muscle stimulators. E-VIVE™ SYSTEM COMPONENTS The e-vive™ system provides NMES treatment to prevent or reduce quadriceps atrophy. The e-vive™ NMES system consists of a NMES control unit, universal USB charging cord, NMES conductive garment, NMES electrodes, and electrode gel.
On/Off/Pause Button Battery Charge Port e-vive™ app available for download In the ON position, the LED light on the e-vive™ controller will illuminate white indicating that the system is powered on and ready, but not connected to Bluetooth. The e-vive™ controller will turn blue when connected to Bluetooth, indicating the mobile e-vive™ app and the mobile device are ready to deliver stimulation treatment. In the OFF position, the LED light on the e-vive™ controller will no longer illuminate.
A protective cover is included in the device packaging to protect it from damage due to an accidental drop and/or an accidental water spill. Battery Charge Port Plug the universal USB charging cord into a standard 5V USB wall charger adapter and then plug into the e-vive™ controller micro USB port to recharge the e-vive™ controller. Charging the Controller When charging the controller battery, the LED light on the controller (near the USB charging port) will blink blue.
4. 2 R an ge o f M o t io n S e n so r Po d The e-vive range of motion sensor is used to evaluate the full movement potential of the knee joint, usually its range of flexion and extension. The sensor pod cannot be removed from the garment. Sensor pod 4. 3 C o n d u c t i ve G ar m en t (N ME S m o d e o n ly ) The e-vive™ NMES conductive garment is used to position the electrodes to your thigh during NMES treatment. Electrodes 4.
NMES Electrodes The electrode covers protect the electrodes from debris and damage while not in use. Before treatment, remove clear plastic covers so the electrodes can contact the skin. After treatment, place the plastic side of the supplied black electrode cover over the electrode. Electrode Covers 4. 5 E lec t r o d e G e l Electrode gel can be used for additional treatment comfort for patients with dry skin.
4. 6 e - viv e™ S ys te m R ep l ac em en t Par t N u m b er s The table below shows a list of replacement electrode sets. Please visit the CyMedica Orthopedics shop page at https://www.cymedicaortho.com/shop to order these items. Contact CyMedica Orthopedics (1-844-CYM-2014) if you have any questions about online ordering. Part e-vive™ NMES Electrodes Set Electrode covers 4.
Pull the white wire connected to the electrode out of garment until second wire (blue, black, red) is exposed. Unplug the white electrode wire. Position a new electrode of the same size (2” x 2” or 2” x 3.5”) so the black sticky side of electrode is facing up, the attachment side is facing down, and firmly place within the electrode outlines on the garment. Plug in the new electrode all of the way so that the metal pin is completely covered. Push electrode wire back into garment as far as possible.
Remove clear plastic liner from top of electrode. After removing the clear plastic liner, place the reusable black electrode cover from packaging or the old electrode on the new electrode. Repeat the above steps for the other two electrodes. 5 5. 1 e-vive™ OPERATING INSTRUCTIONS C h ar gi n g an d Sto r in g t h e e - v iv e™ C o n tr o l ler When not in use, the e-vive™ controller can be stored in the docking pod attached to the conductive garment.
5. 2 We ar in g t h e N M E S Co n d u c t i ve G ar me n t - N M E S Tr eat m en t The e-vive™ NMES System is designed to specifically target and activate two important muscles of the quadriceps: the vastus medialis oblique (VMO) muscle located near the inner part of the upper knee area, and the rectus femoris (RF) muscle located at the top-middle part of the thigh.
(Note: The pictures shown here are for the right leg garment). Electrode Flap (Inside) Blue surface (Place against back of thigh) Circular cutout (Place behind knee) Pull garment strap 1 over the electrode flap and attach to the garment as shown. Wrap the calf side flap over the top of the leg. Pull garment strap 2 over the calf flap and attach as shown. Verify the front knee opening fits comfortably around the knee.
4 3 1 2 Refer to the CyMedica Orthopedics website, www.cymedicaortho.com for instructions related to the use of evive™ post-operative range of motion knee brace. 2 2 4 1 5 3 5. 3 Op e r a t in g t h e e - v i ve ™ D ev ic e fo r N M E S Tr e a t me n t All electrodes should be in direct contact with the skin. Turn on the evive™ controller by pressing the power button.
Purple White Blue Yellow Yellow blinking Yellow/White blinking Yellow/Blue blinking Red Red flashing Controller is ON, not in dock Controller is ON and in dock, not connected to Bluetooth Controller is ON, in dock, connected to Bluetooth Treatment in progress, not outputting energy Treatment in progress, outputting energy Treatment paused, not connected to Bluetooth Treatment paused, connected to Bluetooth Battery critically low, needs to charge Failure, call Customer Service Pairing Your e-vive™ Controll
Notes: Once paired, your e-vive™ controller and smart device should connect automatically every time they are both switched on with Bluetooth enabled. If the pairing fails, your smart device will advise you of this and prompt you to retry the process. Once the controller and the app on your smart device are successfully paired you may start using your e-vive™ system. Secure the controller into the dock on the garment and position the garment as instructed in section 5.2.
App Home Screen Overview Now that you have secured your garment properly to your leg and have paired your evive™ controller to the e-vive™ app on your smart device, you are ready to use the e-vive™ system. The app home screen, or e-vive™ Dashboard, allows you to view your weekly progress, begin stimulation treatment for muscle strengthening, as well as test your range of motion. The top section of the e-vive™ app will display a Dashboard Ring of your daily progress.
On the Stimulation Level screen, you set the intensity levels. Each level begins with a setting of 0 and has a maximum setting of 100. Tap “+” to increase knee treatment intensity Tap “-” to decrease knee treatment intensity NOTE: It is common to have different desired intensity levels for the KNEE and THIGH. Increase the intensity until you achieve a strong, comfortable muscle contraction. Once the intensity levels are set, tap the “START TREATMENT” button. NMES treatment programs are 20 minutes long.
Treatment Completion Once treatment is complete, this screen will be displayed: 5. 4 Op e ra t in g t he e- v i ve™ d ev ic e a s a b i l a te r al s ys t em ( 2 gar m en t s an d o n e c o n tr o l ler ) The bilateral e-vive™ system is indicated for treatment of both the left and right knee. Only one controller is needed for use with both garments. Once the device has been paired using either garment it is not necessary to pair the other garment.
the garment below the knee should be aligned with the center of your shin. Adjust the garment as needed for proper orientation. To begin the range of motion test, position yourself at the edge of the seat, in a chair where your knee can extend and bend comfortably. It is important that the garment be adequately secured to your leg as described in section 5.2 (wearing the NMES conductive garment). Extension: From a seated position at the edge of a seat, slide your heel on the floor to fully extend your leg.
Flexion: From a seated position at the end of a chair, slide your heel on the floor toward your buttock. When necessary, move from your heel on floor to your toe. If you feel you can achieve even greater flexion, it may be necessary to remove your toe from the ground and continue to move your heel up towards your buttock. In the e-vive™ app Range of Motion test, tap “Save” when you have reached your maximum flexion.
6 e-vive™ SYSTEM TROUBLESHOOTING e-vive™ app Error Messages: Bluetooth connection is interrupted If during a stimulation treatment the Bluetooth connection signal is disrupted, the stimulation will continue. To pause the stimulation, momentarily press the on/off button on the e-vive™ controller. To stop the stimulation, press and hold the on/off button on the e-vive™ controller for 2 seconds to turn off the device.
Troubleshooting Table Problem Possible cause Loose connection The Controller is not responding Weak stimulation Stimulation stops during treatment Stimulation weakens during treatment Battery discharged Bad connection Defective electrode Damaged or worn electrode(s) Electrode placement Stimulation only felt on one muscle group (VMO or Rectus Femoris) Intermittent Output Stimulation is not producing the usual sensation Recharge e-vive controller Verify the connection of lead wires to electrodes Repl
7 LIST OF ERROR MESSAGES Error Message Cannot proceed without garment Over temperature condition detected Failed to configure controller 8 Solution Fully insert controller into dock on conductive garment and make sure controller is on. Shut down controller and mobile application, allow to cool, and turn power back on. Reconnect your mobile device with your controller by re-scanning the garment. CUSTOMER SERVICE & MAINTENANCE 8.
8. 2 Re p a ir The CyMedica Orthopedics e-vive™ system is not field-serviceable and has no user serviceable parts inside the device. If the device appears to be damaged or to be non-functional, please contact CyMedica Orthopedics Customer Service. Do not attempt to repair any part of the CyMedica Orthopedics e-vive™ System. Never dismantle the e-vive™ controller due to risk of electric shock. CyMedica Orthopedics, Inc.
The electrodes are reusable as long as they are clean, still tacky, and without any sign of visible damage. Replace the electrodes if they no longer adhere to the skin properly. Calibration The CyMedica Orthopedics e-vive™ System does not require equipment calibration. Each e-vive™ stimulator is tested prior to shipment. Its characteristics do not vary under normal operating conditions. 8.
The e-vive™ controller and sensor in the NMES conductive garment is a piece of electronic equipment and may include substances that can damage the environment. DO NOT dispose of the device in municipal waste. Please deliver the device to a suitable collection point for recycling of electronic equipment. When the electrodes no longer stick well to your skin, dispose of them in a receptacle out of reach of children and pets. 8.
9 TECHNICAL SPECIFICATIONS 9.
NMES Waveforms Full output, Voltage across 500Ω load Full output, Voltage across 2,000Ω load Full output, Voltage across 10,000Ω load 2/2020 CY-0090-018, Rev.
Rated Outputs – POST-OP NMES Parameter Output Voltage (VRMS) Output Voltage (VPEAK) Output Current (IRMS) Output Current (IPEAK) Output Frequency DC Component: Approx. Positive Pulse Width Interphase Interval Duty Cycle Net Charge 500 Ω 2 kΩ 10 kΩ 9.2 V 64 V 18.3 mA 128 mA 50 pps 16.4 V 96 V 8.2 mA 48 mA 50 pps 21.3 V 111 V 2.1 mA 11 mA 50 pps 3.4 V 7.0 V 9.0 V 5 ms 15 ms 25% 366 µC 5 ms 15 ms 25% 5 ms 15 ms 25% 500 Ω 2 kΩ 10 kΩ 9.2 V 64 V 18.3 mA 128 mA 50 pps 16.4 V 96 V 8.
9.
Warning: The use of accessories, other than those recommended by the manufacturer, may result in stronger emissions or reduce the immunity of the e-vive™ device. Warning: The e-vive™ device should not be used beside or stacked on top of any other equipment. If you must use it side by side or on top of another system, you should check that the evive™ device works properly in the chosen configuration.
Electrical fast transient/burst IEC 61000-4-4 ±2 kV for power supply lines ±1 kV for input/ output lines Not Applicable – Battery powered Not Applicable – signal lines less than 3 meters Mains power quality should be that of a typical commercial or hospital environment. Surge IEC 61000-4-5 ±1 kV line to line ±2 kV line to earth Not Applicable – Battery powered Mains power quality should be that of a typical commercial or hospital environment.
GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC IMMUNITY The e-vive™ is intended for use in the electromagnetic environment specified below. The customer or the user of the e-vive™ should assure that it is used in such an environment.
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered.
9. 4 F CC an d IC 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. FCC RF Radiation Exposure Statement FCC ID: 2AU28-CY1000330 Model: e-vive II The minimum distance of the radiating structure of this device, during normal operation, is 15mm from the body of the user (§2.1093).
Warning: Changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment. (Part. 15.21) Bluetooth Communication between the e-vive™ Device and the Smartphone is via Bluetooth. Bluetooth Specifications: Bluetooth Low Energy (BLE) modulation (as defined in the Bluetooth Core Specification) is Gaussian (shaped, binary). Frequency Shift Keying (GFSK) with a modulation index of 0.
Quality of Service in the e-vive™ device is entirely managed by the Bluetooth Standard Technology and does not require you to configure any settings to perform device functions. The coexistence of the e-vive™ wireless system has been tested for up to forty wireless and microwave devices near the 2.4 GHz band, including 5 e-vive™ devices operating simultaneously within a 50 meters radius. 9.
4) 5) If the controller LED light is blue, this indicates that your mobile device is connected via Bluetooth. You should see the app recognize the controller and indicate the controller battery level in the top-right section of the app home screen (Dashboard). If the controller and mobile device are still not connected via Bluetooth, reconnect the controller to your mobile device by the following: In the e-vive™ mobile app, from the Dashboard, select ‘Settings’ then the ‘Bluetooth Pairing’ button.
revision 4.0 or higher Memory: At least 200MB of available RAM memory Android devices, with minimum requirements: OS Level: The OS level must be at 6.0 or higher Bluetooth: The device must have Bluetooth with at least revision 4.
