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

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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 ................................................................. 9
3.4 WARNINGS ................................................................................ 9
3.5 PRECAUTIONS ......................................................................... 10
3.6 ADVERSE REACTIONS .............................................................. 13
4 E-VIVE SYSTEM COMPONENTS .................................................... 13
4.1 e-vive Controller ..................................................................... 13
4.2 Range of Motion Sensor Pod .................................................. 16
4.3 Conductive Garment (NMES mode) ....................................... 16
4.4 Electrodes and Covers ............................................................ 16
4.5 Electrode Gel .......................................................................... 17
4.6 e-vive System Replacement Part Numbers ............................ 18
4.7 NMES Garment Electrodes Replacement Instructions ........... 18
5 E-VIVE OPERATING INSTRUCTIONS ............................................. 20
5.1 Charging and Storing the e-vive Controller ............................ 20
5.2 Wearing the NMES Conductive Garment ............................... 21
5.3 Operating the e-vive Device for NMES Treatment ................. 23
5.4 Operating the e-vive device as a bilateral system (2 garments
and one controller) ................................................................. 30
5.5 Performing Range of Motion Test .......................................... 30
6 E-VIVE SYSTEM TROUBLESHOOTING ........................................... 33
7 LIST OF ERROR MESSAGES .......................................................... 35
8 CUSTOMER SERVICE & MAINTENANCE ........................................ 35
8.1 Customer Service .................................................................... 35

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8.2 Repair ...................................................................................... 36
8.3 Cleaning and Maintenance ..................................................... 36
8.4 Operating Conditions .............................................................. 37
8.5 Transportation and Storage Conditions ................................. 37
8.6 Shelf Life or Use By Date Information .................................... 37
8.7 Expected Service Life and Disposal Information .................... 37
8.8 Replacement Parts Ordering Information .............................. 38
8.9 Limited warranty .................................................................... 38
9 TECHNICAL SPECIFICATIONS ....................................................... 39
9.1 Waveform Information ........................................................... 39
9.2 Compliance Declaration ......................................................... 42
9.3 Guidance and Manufacturer’s Declaration – Electromagnetic
Emissions .................................................................................. 42
9.4 FCC and IC ............................................................................... 49
9.5 Wireless Quality of Service and Coexistence .......................... 50
9.6 Recommendations for Safe Wireless Connections................. 51
9.7 Wireless Connections Troubleshooting .................................. 51
9.8 Mobile Device Compatibility .................................................. 52
9.9 Measurements Accuracy ........................................................ 53
9.10 Materials Specifications .......................................................... 53

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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, comfortable muscle
activation. In NMES mode, pulses stimulate motor points of target
muscles causing a contraction. The e-vive has two different NMES
treatment programs: Post-Operative treatment and Strength building.
Each program treats atrophy and re-educates nerve-to-muscle
communication.
Read this User’s Manual carefully before using the device. Pay attention to the
Safety Information and Warnings throughout the manual.
Caution: Federal law restricts this device to sale by or on the order of a
practitioner licensed by the law of the State in which he/she practices to use
or order the use of the device.
This product is covered by one or more U.S. Patents, see
www.cymedicaortho.com for details.
2 INTENDED USE
The e-vive System is an electrotherapy device with a neuromuscular
electrical stimulation (NMES) treatment mode. The intended use of the e-
vive NMES device, including any indications for use, is limited to use in
rehabilitation, including providing adjunctive therapy in rehabilitation for
medical purposes.
In addition, the e-vive device is intended to evaluate joint function by
measuring and recording range of motion.

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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. The device
may be used in a health care facility setting or by a patient or lay operator
in a home environment.

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3 SAFETY INFORMATION
3.1 EXPLANATION OF SYMBOLS
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
Symbol
Reference number; part number
ISO 15223-1:2012(E)
5.1.6
Lot number
ISO 15223-1:2012(E)
5.1.5
Serial Number
ISO 7000:2014-2498
Manufacturing date
ISO 15223-1:2012(E)
5.1.3
Legal Manufacturer name and address
ISO 15223-1:2012(E)
5.1.1
Follow instructions for use
ISO 7010:2011-M002
Expiration date ISO 15223-1:2012(E)
5.1.4
The system is provided Non Sterile ISO 15223-1:2012(E)
5.2.7
Prescription only (USA)
FDA General Guidance
Device Labeling
– FDA 89-4203
Minimum and maximum operating
range temperature range ISO 15223-1:2012(E) 5.3.7
Humidity Limitation ISO 7000:2014-2620

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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
Do not dry clean ISO 7000:2014-3114
CE Marking Medical Device
Directive
93/42/EEC
Authorized Representative ISO 15223-1:2012(E)
5.1.2
ETC Classified C US, 9900900, Electronic Testing
Lab, indicates product meets US and Canadian
product safety standards. This device conforms
to AAMI Std. ES60601-1. Certified to CAN/CSA
Std. C22.2#60601-1
ISO 60601-1:2005(E)
Attention – consult instructions for
use
ISO 15223-1:2012(E)
Caution ISO 15223-1:2012(E)
5.4.4
IP20
Protection against medium-sized
foreign bodies with a diameter > 12
mm
IEC 60529 Edition 2.1
2001-02

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IP02
Protection against vertically falling
water drops when enclosure tilted up
to 15
°
IEC 60529 Edition 2.1
2001-02
IP22
Protection against medium-sized
foreign bodies with a diameter > 12
mm; Protection against vertically falling
water drops when enclosure tilted up
to 15
°
IEC 60529 Edition 2.1
2001-02
Type BF applied parts
IEC 60417.1-2004-5333
Lead wires comply with the
performance standard for electrode
lead wires (21 CFR part 898)
IEC 60417.1-2004-5035
Product contains electrical and
electronic equipment. User should
not discard this product along with
other household waste; it must be
collected and treated separately.
Directive 2016/19/EU
Wireless ISO 7000:2014-3600
Bluetooth Low Energy IEEE 802.15.1-2005
3.2 DEFINITIONS
 Applied Parts – Part of the medical equipment, which is
designed to come into physical contact with the patient, or
parts that are likely to be brought into contact with the
patient. For example, the electrodes are an example of an
applied part.

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3.3 CONTRAINDICATION
 Powered muscle stimulators should not be used on patients with
cardiac demand pacemakers.
3.4 WARNINGS
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.
Severe spasm of the laryngeal and pharyngeal muscles may
occur, and the contractions may be strong enough to close the
airway or cause difficulty in breathing.
4. Stimulation should not be applied transthoracically in that the
introduction of electrical current into the heart may cause
cardiac arrhythmias.
5. Stimulation should not be applied transcerebrally.
6. Stimulation should not be applied over swollen, infected, or
inflamed areas or skin eruptions, e.g., phlebitis,
thrombophlebitis, varicose veins, etc.
7. Stimulation should not be applied over, or in proximity to,
cancerous lesions.
8. Do not apply stimulation in the presence of electronic monitoring
equipment (e.g., cardiac monitors, ECG alarms), which may not
operate properly when the electrical stimulation device is in use.
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. The simultaneous connection may result in burns at
the site of the electrodes and possible damage to the device.
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.

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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 PRECAUTIONS
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. Caution should be used for patients with suspected or diagnosed
epilepsy.
4. Caution should be used in the presence of the following:
a- When there is a tendency to hemorrhage following acute
trauma or fracture;
b- Following recent surgical procedures when muscle
contraction may disrupt the healing process;
c- Over the menstruating or pregnant uterus; and
d- Over areas of the skin which lack normal sensation.
5. Some patients may experience skin irritation or hypersensitivity
due to the electrical stimulation or electrical conductive
medium. The irritation can usually be reduced by using an
alternate conductive medium, or alternate electrode placement.
6. Electrode placement and stimulation settings should be based on
the guidance of the prescribing practitioner.
7. Powered muscle stimulators should be kept out of the reach of
children.
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.
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. Attach

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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 cm2 will risk
suffering a burn injury. Caution should always be exercised with
current densities more than 2 mA/cm2.
12. 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.
13. Keep this device out of the reach of children.
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.
16. Care should be used to avoid tripping on lead wires.
17. Do not operate this device while charging.
18. Do not disconnect any stimulation cables during a session while
the stimulator is switched on. Switch the stimulator off first.
Always turn off the stimulator before moving or removing any
electrodes during a session.
19. Do not apply stimulation in the vicinity of metal. Remove
jewelry, body piercings, buckles or any other removable metallic
product or device in the area of stimulation.
20. Never use the electrodes contra-laterally; i.e., do not use two
pins connected to the same channel on opposite segments of the
body.
21. For an effective stimulation and maximum comfort, follow your
clinician instructions or the following guideline for placing the
electrodes on the Conductive Garment.
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. RF emitting

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equipment should be used no closer than 30 cm (12 inches) to
any part of the CyMedica e-vive II NMES System.
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. 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:
a. Move away from the equipment or object.
b. If possible, turn off the equipment or object,
26. The presence of lint, dust, pets, pests, and children in the
operating environment can impact the performance of the e-vive
system. Prior to use, the system should be inspected for the
following:
a. Dust, dirt, lint, or pet hair on the face of the electrode(s).
Should the electrodes pick up small amounts of debris you
may use a drop of water or the electrode gel on your finger
to gently rub the debris off the electrode. Electrodes are
reusable as long as they are clean without any sign of
visible damage and still tacky. Replace the electrodes if
they no longer adhere to the skin properly.
b. Damage may be caused to the e-vive controller, e-vive
cradle, or electrode wires by pests, pets, or children. 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.

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3.6 ADVERSE REACTIONS
 Skin irritation and burns beneath the electrodes have been
reported with the use of powered muscle stimulators.
4 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, NMES
conductive garment, universal USB charging cable, NMES electrodes,
electrode gel, and electrode covers. The user interface is controlled by
a proprietary smart phone or tablet CyMedica e-vive application (app)
that must be downloaded from an app store and installed to your
personal smart device in order to operate the control unit.
To download the app: go to the App Store (Apple) or Google Play
(Android) for your device and search for “CyMedica e-vive”.
Note: Be sure to select the app with the icon shown
here:
Select download/install and follow the prompts to
complete your profile.
4.1 e-vive Controller
The e-vive controller is the stimulation generator that is operated
through the e-vive app. By using therapy controls via the e-vive app,
the controller sends the selected therapeutic program to the electrodes
on the body. The controller has a single tactile power button for
on/off/pause user control, and the e-vive app controls the levels of
intensity and captures progress and usage data.

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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.
The controller will be off and will not deliver treatment.
Controller Protective Cover
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.
On/Off/Pause
Button
Battery
Charge Port
e
-
vive
app available for download

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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. When fully charged, the
LED light will stop blinking and be solid blue. When the charging cable
is disconnected the charging LED blue light will turn off.
The battery can be fully charged in approximately 4 hours. A fully
charged controller can deliver at least three 20-minute treatment
programs before it needs to be charged again.
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.

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4.2 Range of Motion Sensor Pod
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 must not be removed from the garment.
4.3 Conductive Garment
The e-vive NMES conductive garment is used to position the electrodes
to your thigh during NMES treatment.
4.4 Electrodes and Covers
The e-vive system uses hydrogel electrodes to deliver the stimulation
program to your thigh muscles. The NMES conductive garment employs
three electrodes: two 2" x 3.5" (5 cm x 10 cm) electrodes and one 2" x 2"
(5 cm x 5 cm) electrode.
These electrodes are reusable if they are clean and without any sign of
visible damage, and still tacky.
Electrodes
Sensor pod

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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.
4.5 Electrode Gel
Electrode gel can be used for additional treatment comfort for patients
with dry skin. CyMedica recommends utilizing a small amount of gel to
hydrate the skin where the electrodes will be placed on the leg.
NMES
Electrodes
Electrode
Covers
Electrode
Gel

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4.6 e-vive System Replacement Part Numbers
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.
4.7 Conductive Garment Electrodes: Placement Instructions
Your garment is provided with pre-installed electrode wires with
protective caps covering the metal conductive pins. Follow these
instructions to initially place or change your electrodes with a new set:
Acquire an electrode set. If this is the first time you are placing
electrodes on your garment, remove the plastic electrode pin covers. If
you are replacing electrodes already on your garment, unplug the
existing wires and gently peel the electrodes from the garment.

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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.

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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 e-vive OPERATING INSTRUCTIONS
5.1 Charging and Storing the e-vive Controller
When not in use, the e-vive controller can be stored in the docking pod
attached to the conductive garment.
To charge the controller, undock it from the docking pod and attach the
supplied USB charging cord to a standard 5V wall adapter charger. Plug
the small, micro USB end of the USB cable into the side of the e-vive
controller. While charging, the LED light (near the USB charging port)
will blink blue until fully charged. Once fully charged, the blue LED light
will stop blinking and remain a solid blue until the charging cable is
removed.