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CYMEDICA Orthopedics e-vive 2.0 User Manual

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CyMedica Orthopedics®
e-vive™ 2.0
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-0090-020
Rev. B
9/2020
CY-0090-020, Rev. B Page 1 of 49

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Summary of Contents for CYMEDICA Orthopedics e-vive 2.0

  • Page 1 CyMedica Orthopedics® e-vive™ 2.0 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-0090-020 Rev. B 9/2020 CY-0090-020, Rev. B Page 1 of 49...

  • 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 ..................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

    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 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 − As a TENS device, indications are for the following conditions: −...

  • Page 6: Safety Information

    SAFETY INFORMATION 3. 1 E XPL A N A T ION O F SY M 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...
  • 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° 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 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

    12. Do not use this device in close proximity (e.g. 1 m) of a shortwave or microwave equipment. The close proximity may produce instability in device performance. 13. Do not service or perform any maintenance on device while in use. 14.
  • Page 11 10. Inspect electrodes before each use. Replace electrodes when they begin to deteriorate or lose adhesion. Poor contact between the electrodes and the patient’s skin increases the risk of skin irritation or burns. Electrodes will last longer if used and stored according to instructions on electrode packaging.
  • Page 12 22. Hair may be trimmed in vicinity of electrodes for additional comfort. 23. Apply electrode gel on the treatment area of the skin for additional comfort. 24. The following equipment or environments could generate enough electromagnetic interference to potentially create unwanted activation of your e-vive system.

  • Page 13: Adverse Reactions

    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 14 On/Off 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.
  • Page 15 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.

  • Page 16: Range Of Motion Sensor Pod

    4. 2 R an ge o f M o tio n S en 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, and is contained in a small pocket of the conductive garment.

  • 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

    The table below shows a list of replacement electrode sets. Please visit the CyMedica Orthopedics online store at https://store.cymedicaortho.com/ to order these items. Contact CyMedica Orthopedics (1-844-CYM-2014) if you have any questions about online ordering. Part Part Number e-vive NMES Electrodes Set...
  • 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 th e N M E S Co n d u c ti ve G ar m en 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.
  • 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

    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 er a tin g th e e - v i ve De v ic e fo r N M E S Tr eat m en t All electrodes should be in direct contact with the skin.
  • Page 24 Light Blue On, not connected Blue On, connected Green Treatment in progress Green blinking Treatment in progress, outputting energy Light Blue blinking Not connected, treatment paused Blue blinking Connected, treatment paused Failure Pairing Your e-vive Controller & Mobile Device Important: You must pair your e-vive controller with your mobile device (smart phone or tablet) before it is inserted into the NMES conductive garment.
  • Page 25 Once the controller and the app on your smart device are successfully paired you may start the using your e-vive system. First, secure the controller in to the cradle on the garment and position the garment as instructed in section 5.2. The controller should be firmly seated into the cradle on the garment.
  • Page 26 This app home screen or e-vive “my dashboard” allows you to view your results, perform electrical stimulation for muscle strengthening, as well as test your range of motion. 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.
  • Page 27 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. Press “+” to increase knee treatment intensity Press “-” to decrease knee treatment intensity NOTE: It is common to have different desired intensity levels for the KNEE AREA and THIGH AREA.

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

    Treatment Completion Once treatment is complete, this screen will be displayed: 5. 4 Op er a t in g th e e- v i ve d e v ice 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 29 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.
  • Page 30 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 31: Vive System Troubleshooting

    e-vive SYSTEM TROUBLESHOOTING e-vive app Error Messages: The e-vive controller is not connected to an accessory If the e-vive controller is powered ON but not communicating with the cradle pod on the NMES conductive garment, this screen will appear. Verify that the e-vive controller is fully seated into the cradle of the conductive garment.
  • 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 Damaged or worn electrode(s) Replace the electrode(s) Electrode placement...

  • Page 33: List Of Error Messages

    CUSTOMER SERVICE & MAINTENANCE 8. 1 Cu sto m er Ser v ic e 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 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

    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 36: Replacement Parts Ordering Information

    Replacement Part Numbers” of this manual for more information. 8. 9 Li m i ted w ar r an ty 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,...

  • Page 37: Technical Specifications

    TECHNICAL SPECIFICATIONS 9. 1 Wa ve fo r m In fo r m 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 38 NMES Waveforms Full output, Voltage across 500Ω load Full output, Voltage across 2,000Ω load Full output, Voltage across 10,000Ω load 9/2020 CY-0090-020, Rev. B Page 38 of 49...
  • Page 39 Rated Outputs – POST-OP NMES Parameter 500 Ω 2 kΩ 10 kΩ Output Voltage (V 9.2 V 16.4 V 21.3 V Output Voltage (V 64 V 96 V 111 V PEAK 18.3 mA Output Current (I 8.2 mA 2.1 mA Output Current (I 128 mA 48 mA...

  • Page 40: Compliance Declaration

    9. 2 Co m p li an c e D ec lar at io n IEC 60601-1:2005, 3rd Edition Medical electrical equipment - Part 1: General requirements for basic safety and essential performance IEC 60601-1-2: 2007, 3rd Edition Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic Compatibility -...
  • Page 41 • 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 42 Not Applicable – ±2 kV for power Electrical fast Mains power quality should be that Battery powered supply lines transient/burst IEC of a typical commercial or hospital Not Applicable – ±1 kV for input/ 61000-4-4 environment. signal lines less output lines then 3 meters Mains power quality should be that ±1 kV line to line...
  • 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 Electromagnetic environment Compliance level Immunity test...
  • Page 44 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 45: Fcc And Ic

    9. 4 FCC an d IC This device complies with Part 15 of the FCC Rules and with RSS-210 of the IC rules. Operation is subject to the following two conditions: 1. This device may not cause harmful interference, and 2.

  • Page 46: Wireless Quality Of Service And Coexistence

    ® Bluetooth The Bluetooth word mark and logos are owned by the Bluetooth SIG, Inc. and any use of such marks by CyMedica Orthopedics, Inc. is under license. 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).

  • Page 47: Recommendations For Safe Wireless Connections

    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 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

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

  • Page 49: 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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