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CYMEDICA Orthopedics e-vive NMES User Manual

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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 more information on the
e-vive system.
CY-0090-018
Rev. A
2/2020
CY-0090-018, Rev. A Page 1 of 53

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  • Page 1 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 more information on the e-vive system. CY-0090-018 Rev. A 2/2020 CY-0090-018, Rev. A Page 1 of 53...

  • Page 2: Table Of Contents

    Contents 1 INTRODUCTION ................4 2 INTENDED USE ................4 3 SAFETY INFORMATION ..............6 EXPLANATION OF SYMBOLS ............. 6 DEFINITIONS ................8 CONTRAINDICATION ..............9 WARNINGS ................9 PRECAUTIONS ................. 10 ADVERSE REACTIONS .............. 13 4 E-VIVE SYSTEM COMPONENTS ............ 13 e-vive Controller ..............
  • Page 3 Repair ..................36 Cleaning and Maintenance ............. 36 Operating Conditions .............. 37 Transportation and Storage Conditions ......... 37 Shelf Life or Use By Date Information ........37 Expected Service Life and Disposal Information ....37 Replacement Parts Ordering Information ......38 Limited warranty ..............

  • Page 4: Introduction

    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.
  • Page 5 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 ...

  • Page 6: Safety Information

    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 for...
  • Page 7 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 Keep the device dry ISO 15223-1:2012(E) 5.3.4 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...

  • Page 8: Definitions

    IP02 Protection against vertically falling IEC 60529 Edition 2.1 water drops when enclosure tilted up 2001-02 to 15 ° IP22 Protection against medium-sized IEC 60529 Edition 2.1 foreign bodies with a diameter > 12 2001-02 mm; Protection against vertically falling water drops when enclosure tilted up °...

  • Page 9: Contraindication

    No modification of this device is allowed. 10. Use this device only with the leads, electrodes, electrode gel, and accessories recommended by CyMedica Orthopedics indicated in this User’s Manual document. 11. Do not use this device while connected to high frequency surgical equipment.

  • Page 10: Precautions

    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.
  • Page 11 the electrodes in such a way that their entire surface is in contact with the skin. 11. Use of electrodes with an active area less than 16 cm will risk suffering a burn injury. Caution should always be exercised with current densities more than 2 mA/cm 12.
  • Page 12 If there is evidence of damage, the system should be returned to CyMedica Orthopedics. 27. Device contains small parts, which may present a choking hazard to small children. Keep the e-vive device and its accessories away from small children.

  • Page 13: Adverse Reactions

    The e-vive system provides NMES treatment to prevent or reduce quadriceps atrophy. The e-vive NMES system consists of a NMES control unit, NMES conductive garment, universal USB charging cable, NMES electrodes, electrode gel, and electrode covers. The user interface is controlled by...
  • Page 14 On/Off/Pause Battery Charge Port Button 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.
  • Page 15 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.

  • Page 16: Range Of Motion Sensor Pod

    The sensor pod must not be removed from the garment. Sensor pod 4. 3 C o n d u c t i ve G ar m en t The e-vive NMES conductive garment is used to position the electrodes to your thigh during NMES treatment. Electrodes 4. 4...

  • Page 17: Electrode Gel

    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.

  • Page 18: E-Vive System Replacement Part Numbers

    4. 6 e - viv e Sy st e m Re p l a c em en t P ar t N u m b er s Please visit the CyMedica Orthopedics shop page at https://www.cymedicaortho.com/shop to order replacement electrodes and supplies. Contact CyMedica Orthopedics (1-844-CYM- 2014) if you have any questions about online ordering.
  • Page 19 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.

  • Page 20: Vive Operating Instructions

    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. e-vive OPERATING INSTRUCTIONS 5.

  • Page 21: Wearing The Nmes Conductive Garment

    5. 2 We ar in g t h e e -v i ve C o n d u c t i ve G ar 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.
  • Page 22 (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.

  • Page 23: Operating The E-Vive Device For Nmes Treatment

    Refer to the CyMedica Orthopedics website, www.cymedicaortho.com for instructions related to the use of e-vive post-operative range of motion knee brace. 1 2 3 4 5 5. 3 Op e r a t in g t h e e - v i ve De v ice fo r N M E S Tr eat m en t...
  • Page 24 STEP 2: Pair the e-vive controller to your smart device You must pair your e-vive controller with your smart device (smart phone or tablet) before starting a treatment. See section 9.8 for compatible mobile devices. Once your profile has been completed, open the e-vive app, tap Stimulation Therapy or Range of Motion Test on the Dashboard and follow the on-screen instructions to pair your...
  • Page 25 Secure the controller into the dock on the garment and position the garment as instructed in section 5.2. The controller should be firmly seated into the dock on the garment. STEP 3: Power on the device: All electrodes should be in direct contact with the skin. Turn on the e-vive controller by pressing the power button.
  • Page 26 What do the different illuminated colors on the power button mean?  Once you begin use, the LED light on the e-vive controller will glow yellow when a treatment is in progress and will blink yellow when the treatment is in progress and is outputting energy. ...
  • Page 27 App Home Screen Overview Now that you have secured your garment properly to your leg and have paired your e-vive 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...
  • Page 28 STEP 4: Begin Stimulation Therapy To start a stimulation session, simply tap Stimulation Therapy on the Dashboard screen. Complete your Pain Assessment and proceed to the Set Stimulation Levels screen. 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.
  • Page 29 Once the intensity levels are set, tap “Start Therapy” to begin your 20-minute treatment session. Both e-vive NMES treatment programs (Strength and Post-Op) are 20 minutes long. Note: The “hamburger icon”( ) located on the upper left of the stimulation screen allows you to navigate back to the Dashboard during stimulation therapy.

  • Page 30: Operating The E-Vive Device As A Bilateral System

    5. 4 Op e ra t in g t he e- v i ve d e v ic e as a b i lat er a l s yst e m (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.
  • Page 31 Extension: From a seated position at the edge of a chair, slide your heel on the floor to fully extend your leg. When you feel you have extended your leg as far as possible, while keeping your heel on the floor, gently push the back of your knee toward the ground.
  • Page 32 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.

  • Page 33: Vive System Troubleshooting

    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.
  • Page 34 Troubleshooting Table Problem Possible cause Solution Loose connection Check the e-vive controller connection to the dock Battery discharged Recharge e-vive controller The Controller is not responding Bad connection Verify the connection of lead wires to electrodes Defective electrode Replace the defective electrodes Damaged or worn electrode(s) Replace the electrode(s) Electrode placement...

  • Page 35: List Of Error Messages

    CUSTOMER SERVICE & MAINTENANCE 8. 1 C u st o m er Se r v ice CyMedica Orthopedics Customer Service can be reached at 1-844 -CYM- 2014. Please contact Customer Service if you need assistance setting up, using, or maintaining the e-vive system or to report any unexpected operation or events.

  • Page 36: Repair

    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. declines all responsibilities for any damages or consequences resulting from unauthorized attempts to open, modify, or repair the stimulator.

  • Page 37: Operating Conditions

    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.

  • Page 38: Replacement Parts Ordering Information

    8. 9 Li m i te d w ar r an t y CyMedica Orthopedics offers a warranty of 1 year for the e-vive system. Should your e-vive system develop a fault within the warranty period, CyMedica Orthopedics will replace your e-vive system free of charge, provided the system: ...

  • Page 39: Technical Specifications

    TECHNICAL SPECIFICATIONS 9. 1 Wa ve fo r m In fo rm at io n Treatment NMES STRENGTH NMES POST-OP Program Pulse shape Monophasic Monophasic Treatment 20 minutes 20 minutes duration Frequency 50 pps 50 pps Pulse width 5 ms 5 ms Duty cycle Work cycle...
  • Page 40 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. A Page 40 of 53...
  • Page 41 Rated Outputs – POST-OP NMES Parameter 500 Ω 2 kΩ 10 kΩ 9.2 V Output Voltage (V 16.4 V 21.3 V 64 V Output Voltage (V 96 V 111 V PEAK 18.3 mA Output Current (I 8.2 mA 2.1 mA 128 mA Output Current (I 48 mA...

  • Page 42: Compliance Declaration

    9. 2 C o mp li a nc e D ec la r at io n IEC 60601-1:2014, 4th Edition Medical electrical equipment - Part 1: General requirements for basic safety and essential performance IEC 60601-1-2: 2014, 4th Edition Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic Compatibility -...
  • Page 43  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 e-vive device works properly in the chosen configuration.
  • Page 44 Not Applicable – Battery powered Electrical fast ± 2 kV Mains power quality should be transient/burst 100 kHz repetition that of a typical commercial or Applicable – IEC 61000-4-4 frequency hospital environment. signal lines less than 3 meters ± 0,5 kV, ± 1 kV line to Mains power quality should be line Surge...
  • Page 45 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. IEC 60601 test Electromagnetic environment Compliance level Immunity test...
  • Page 46 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.
  • Page 47 RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF COMMUNICATIONS EQUIPMENT AND THE E-VIVE The e-vive is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the e-vive can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the e-vive as recommended below, according to the maximum output power of the communications equipment.
  • Page 48 For some services, only the uplink frequencies are included. The carrier shall be modulated using a 50 % duty cycle square wave signal. As an alternative to FM modulation, 50 % pulse modulation at 18 Hz may be used because while it does not represent actual modulation, it would be worst case.

  • Page 49: Fcc And Ic

    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.

  • Page 50: Wireless Quality Of Service And Coexistence

    —Consult the dealer or an experienced radio/TV technician for help. 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.

  • Page 51: Recommendations For Safe Wireless Connections

    often enough that transient data is regularly updated. The wireless 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.

  • Page 52: Mobile Device Compatibility

    If you are still experiencing difficulties, call CyMedica Orthopedics Customer Service. Note: Android devices require Location Services to be enabled for proper connection to the e-vive controller.

  • Page 53: Measurements Accuracy

    NMES electrodes: Conductive silicon rubber layer and a conductive hydrogel layer NOTE: The e-vive conductive garment and NMES electrodes are “not made with natural rubber latex”. Emergo Europe CyMedica Orthopedics Prinsessegracht 20 19120 North Pima Road 2514 AP The Hague Suite 135...

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