CYMEDICA Orthopedics e-vive User Manual
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CYMEDICA Orthopedics e-vive User Manual

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CyMedica Orthopedics®
e-vive™
USER'S MANUAL
Read this manual carefully before operating the e-vive 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-0090-001
Rev. M
1/2019
CY-0090-001, Rev. M Page 1 of 49

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  • Page 1 CyMedica Orthopedics® e-vive™ USER’S MANUAL Read this manual carefully before operating the e-vive 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-0090-001 Rev. M 1/2019 CY-0090-001, Rev. M Page 1 of 49...

  • Page 2: Table Of Contents

    Wearing the NMES Conductive Garment- NMES Treatment . 21 Operating the e-vive Device for NMES Treatment ....23 Operating the e-vive device as a bilateral system ....28 Performing Range of Motion Test ......... 28 6 E-VIVE SYSTEM TROUBLESHOOTING ..........31 7 LIST OF ERROR MESSAGES .............
  • Page 3 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 ....35 Replacement Parts Ordering Information ......36 Limited warranty ..............

  • Page 4: 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 − 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. The device may be used in a health care facility setting or by a patient or lay operator in a home environment.

  • Page 6: Safety Information

    SAFETY INFORMATION 3.1 EXPL AN AT I ON OF SYM B OL S The following symbols are used in this user manual, and on the device packaging, or on the device or accessory labeling. Symbol Description Reference Number for Symbol Reference number;...
  • 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 15° Protection against medium-sized IP22 IEC 60529 Edition 2.1 foreign bodies with a diameter > 12 2001-02 mm; Protection against vertically falling water drops when enclosure tilted up 15°...

  • Page 9: Contraindication

    9. 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

    8. Powered muscle stimulators should be used only with the leads and electrodes recommended for use by the manufacturer. 9. Portable powered muscle stimulators such as e-vive device should not be used while driving, operating machinery, or during any activity in which involuntary muscle contractions may put the user at undue risk of injury.
  • Page 11 14. Do not allow any foreign bodies (soil, water, metal, etc.) to penetrate the e-vive device and the battery compartment. 15. Do not use the e-vive Conductive Garment in proximity of fire or excessive heat sources due to the risk of fire. Make sure that the electrodes cover the connectors on the garment before use to avoid shocking, skin irritation, and burns.
  • Page 12 Power lines or power generators. Television and radio transmitting towers (safe if outside the fenced area). 25. If you suspect that equipment is interfering with the e-vive system, do the following: Move away from the equipment or object. If possible, turn off the equipment or object, 26.

  • Page 13: Adverse Reactions

    It sends the selected therapeutic program to the electrodes on the body. The controller has a single tactile power button for on/off user control, and the e-vive app controls the levels of intensity and captures rehabilitation and usage data.
  • Page 14 Battery Charge Port e-vive app available for download In the ON position, the LED light on the e-vive controller will illuminate light blue indicating that the system is powered on and ready, but not connected to Bluetooth. The e-vive controller will turn a darker blue when connected to Bluetooth, indicating the mobile e-vive app and the mobile device are ready to deliver stimulation treatment.
  • Page 15 Universal USB cord The universal USB charging cord should be plugged into a standard 5V USB Wall adapter to charge the e-vive controller. A power supply is not provided with the e-vive system. 1/2019...

  • Page 16: Range Of Motion Sensor Pod

    CyMedica agent. Sensor pod 4.3 Co n du c t ive G a rment (NM ES mod e on ly) The e-vive NMES Conductive Garment is used to position the electrodes to your thigh during NMES treatment. Electrodes 4.4 Elec t ro d es an d Co vers...

  • 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 4.5 Elec t ro d e G el...

  • Page 18: E-Vive System Replacement Part Numbers

    4.6 e-vive Sys t em R ep la c ement Pa rt Nu mb ers The table below shows a list of replacement electrode sets. Please visit the CyMedica Orthopedics shop page at Contact https://www.cymedicaortho.com/shop to order these items. 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 4”) 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

    OPERATING INSTRUCTIONS 5.1 Ch a rgin g an d Sto rin g t h e e-vive Co nt ro ller When not in use, the e-vive controller can be stored in the docking pod attached to the conductive garment or pod accessory.

  • Page 21: Wearing The Nmes Conductive Garment- Nmes Treatment

    5.2 Wea rin g th e NM ES Con du c t ive G a rment - NM ES T rea t men 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 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

    1 2 3 4 5 5.3 Op era t in g t h e e-vive Devic e fo r NM ES T rea t ment All electrodes should be in direct contact with the skin. Turn on the e- vive controller by pressing the power button.
  • Page 24 Bluetooth must be enabled on your smart device in order to connect to the controller. Notes: Once paired, your e-vive controller and smart device should • connect automatically every time they are both switched on with Bluetooth enabled.
  • Page 25 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 mobile device, you are ready to use your e-vive system. 1/2019...
  • Page 26 The top section of the e-vive app will display your daily progress. Each day you will be asked to conduct 20-minute stimulation muscle strengthening sessions and a range of motion test. To start a stimulation session, simply press the “session 1, 2 or 3”...
  • Page 27 You may terminate your therapy session at any time by pressing the orange “top “X” icon on the screen. You may also terminate/stop the stimulation treatment at any time by pressing the on/off power button on the e-vive controller. 1/2019 CY-0090-001, Rev. M Page 27 of 49...

  • Page 28: Operating The E-Vive Device As A Bilateral System

    5.4 Op era t in g t h e e-vive d evic e as a b ila t era l s ys t em (2 ga rmen t s a nd o n e c on t ro ller) The bilateral e-vive system is indicated for treatment of both the left and right knee.
  • Page 29 In the e-vive app Range of Motion test, press the pink “Record” button when your leg is extended as far as possible.
  • Page 30 In the e-vive app Range of Motion test, press the pink “Record” button when your leg is flexed as far as possible.

  • Page 31: Vive System Troubleshooting

    Battery discharged Should the e-vive controller internal battery become discharged, a screen will be displayed on the e-vive app once treatment is complete. The e-vive controller needs to be recharged before the next treatment. Refer to Section 5.1, “Charging the e-vive controller” for battery charging instructions.
  • Page 32 Troubleshooting Table Problem Possible cause Solution Loose connection Check the e-vive controller connection to the cradle 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...

  • Page 33: List Of Error Messages

    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. When returning any products, please include your name, address, phone number, and Return Material Authorization (RMA) number provided by Customer Service.

  • Page 34: 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 35: Operating Conditions

    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. 8.4 Op era t in g Con d it ion s The e-vive device should be operated in temperatures between 50°F...

  • Page 36: Replacement Parts Ordering Information

    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.

  • Page 37: Technical Specifications

    TECHNICAL SPECIFICATIONS 9.1 Wa vefo rm In fo rmat 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 12 s 13 s...
  • Page 38 NMES Waveforms Full output, Voltage across 500Ω load Full output, Voltage across 2,000Ω load Full output, Voltage across 10,000Ω load 1/2019 CY-0090-001, Rev. M Page 38 of 49...
  • Page 39 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 40: Compliance Declaration

    General requirements for basic safety and essential performance 9.3 Guidance and Manufacturer’ s Declaration – Electromagnetic Emissions • The e-vive device needs special EMC precautions and must be installed and started according to the EMC information supplied in this manual. 1/2019...
  • Page 41 61000-3-3 GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC IMMUNITY e-vive is intended for use in the electromagnetic environment specified below. The customer or user of the e-vive system should assure that it is used in such an environment Test level IEC...
  • Page 42 Voltage dips, Mains power quality should be that of in U short a typical commercial or hospital interruptions and environment. If the user of the e-vive for 5 cycles voltage variations Not Applicable – requires continued operation during 70% U...
  • Page 43 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...
  • Page 44 If the measured field strength in the location in which the E-VIVE device is used exceeds the applicable RF compliance level above, the e-vive device should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re orienting or relocating the e-vive device.

  • Page 45: Fcc And Ic

    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) The e-vive system contains the following Bluetooth transmitter module: FCC ID: S9NSPBTLERF IC: 8976C-SPBTLERF IC: ATCB017288 1/2019 CY-0090-001, Rev.

  • Page 46: Wireless Quality Of Service And Coexistence

    The BLE maximum output power levels in e-vive are -2.1dBm from the controller (to the mobile device or the sensor pod) and -4.9dBm from the sensor pod (to the controller). The BLE links used in e-vive have a range of up to 10 meters (between the mobile device and controller) and up to 1 meter (between the controller and sensor pod).

  • Page 47: Recommendations For Safe Wireless Connections

    The coexistence of the e-vive wireless system has been tested for up to thirty wireless and microwave devices near the 2.4 GHz band, including 5 e-vive devices operating simultaneously within a 50 meters radius.

  • Page 48: Mobile Device Compatibility

    In the event that your e-vive mobile app is not connecting to the internet, take the following steps: 1) Ensure that your WiFi is enabled in your device settings and you are connected to a valid WiFi connection.

  • Page 49: Measurements Accuracy

    • Memory: At least 200MB of available RAM memory Note: Certain operating systems and security software can interfere with the operation of the e-vive app and the user may need to work with their phone provider to resolve any incompatibilities in operating system software with CyMedica assistance.

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