Reliefband Technologies RELIEFBAND 2.0 User manual

(3.)THERAPY INTENSITY
LEVEL INDICATOR
(6.) HYPOALLERGENIC
CONTACTS
(5.)THERAPY ON INDICATOR
(1.) POWER ON/OFF/INTENSITY
DOWN BUTTON
(4.) BATTERY/CHARGING
INDICATOR
(2.) INTENSITY UP
BUTTON
(8.) LATCH(9.) CINCH BAR
(12.) CONTACT
ASSEMBLY
(10.) SMART BAND
(7.) CHARGING PORT
(13.) MAGNETIC CONNECTOR
(14.) USB CHARGING CABLE
(11.) SIMPLE BAND
2
3
1
P6
2APPLY
Clean the area rst.
Apply a small drop of gel and spread in a circle
about the size of a large coin with an even sheen
(i.e., a thin layer with a shiny appearance).
1AREA
Find the starting area (P6) on the wrist.
Using either wrist, the correct area is in-between the
two tendons on the underside of the wrist – about
two nger widths above the wrist crease.
QUICK REFERENCE INTRODUCTION SAFETY INFORMATION PACKAGE CONTENTS CHARGING THE DEVICE
HOW RELIEFBAND® 2.0 WORKS
GET TO KNOW RELIEFBAND® 2.0
INDICATIONS FOR USE
Reliefband® 2.0 is indicated for use in the treatment
of nausea, retching and vomiting due to motion
sickness, chemotherapy and morning sickness
associated with pregnancy.
Reliefband® 2.0 is also indicated as an adjunct to
antiemetics in reducing postoperative nausea.
220 Gibraltar Road, Suite 270, Horsham, PA 19044
Reliefband® 2.0 is a registered trademark of
Reliefband Technologies LLC.
Reliefband® technology is protected by US Patent
No. 6,076,018; 7,127,288. Japan Patent No. 4,812,810;
4,220,129. Canadian Patent No. 2,449,554; 2,342,873.
Australian Patent Nos. 766463, 2004200090 and
2002305786, and European Patent No. 1,109,595-UK,
France and Germany (DE 69940405.3).
Designed in USA. Made in Malaysia.
©2017 Reliefband Technologies
EMERGO EUROPE
Prinsessegract 20
2514 AP The Hague
The Netherlands
In the U.S.A., call 1-877-735-2263
9:00 AM - 5:00 PM Mon. - Fri. CST
Document number: 6006980 Rev. B
DESCRIPTION OF THE 2.0:
Reliefband® 2.0 is a rechargeable, digital treatable
device that is worn on the wrist. It consists of
a hypoallergenic band with a control panel on
top and two electrical contacts underneath.
The two contacts must be placed rmly against
the underside of your wrist at the P6 location. It
provides relief from nausea, retching, and vomiting
due to motion sickness, chemotherapy and
morning sickness associated with pregnancy and
postoperative nausea. A fully charged battery will
last for approximately 18 hours of continuous use at
the mid-power level or below.
1
Reliefband® 2.0 delivers proprietary
pulses from the contacts on the
Smart Band that signal the median
nerve at the P6 location on the
underside of the wrist.
2
These signals travel through
the body’s nervous system to
the part of the brain which
controls nausea, retching
and vomiting.
3
The signals have a
rebalancing eect,
normalizing nerve
messages from the brain
to the stomach and
reducing symptoms of
nausea, retching and
vomiting.
Nausea, retching, and vomiting are probably some of
the worst sensations you can feel – the combination
of dizziness, lightheadedness, heightened sensitivity
to smells, bloated abdominal discomfort, retching and
the ultimate involuntary evacuation of the stomach.
Drug-free, Reliefband® 2.0 uses clinically-proven
technology to quickly and eectively relieve nausea,
retching, and vomiting. Reliefband® 2.0 is the result of
many years of clinical research and development and
millions of dollars of investment. It is the rst of a new
class of Digital Wearable Technologies.
– it’s aWearable that does something other than
measure things
- a “Digital Wearable Treatable”
Reliefband® 2.0 uses patented technology that
leverages the body’s natural neural pathways to
block signals to the center in the brain responsible
for the sensation of nausea. It has been used to treat
nausea, retching and vomiting in clinical settings and
hospitals for many years. Now it is available over-the-
counter for the relief of nausea associated with motion
sickness from travel, vertigo, VR/Sim, chemotherapy
and for morning sickness associated with pregnancy.
Reliefband is also an adjunct to antiemetic therapy in
reducing postoperative nausea.
CAUTION
• Pacemaker users - Use this device on the
wrist and only as directed to prevent possible
interference with your pacemaker. Avoid placing
the electrical contacts directly on your chest or
near the pacemaker. Consult your doctor before
using device.
• Nausea, retching and vomiting may be signs of a
serious health problem. Contact a doctor if your
nausea, retching and vomiting persists.
• Reliefband® 2.0 should only be used on the wrist.
Do not use it on any other area of the body.
• Reliefband® 2.0 does not cure the underlying
causes of nausea, retching and vomiting.
• The relief you get may vary depending on
your body’s individual characteristics, and any
medications that you may be taking could cause
your body to respond dierently.
• Reliefband® 2.0 should be kept out of reach of
young children.
(1) Reliefband® 2.0
(1) Reliefband® Conductivity Gel
(1) Instructions For Use
(1) Magnetic USB Charging Cable
INSTRUCTIONSFOR USE
Model:Reliefband®2.0
DRUG-FREERELIEF
FROMNAUSEA,RETCHING AND VOMITING
2.0
• If you are unable to tolerate any food or liquids or
are experiencing weight loss you should contact
your doctor.
• Reliefband® 2.0 is IPX4 splash-resistant. This
product is resistant to splashing water (rain,
waves).
• Avoid splashing water while charging.
• Do not immerse Reliefband® 2.0 in water or wear
while bathing, showering or swimming.
SIDE EFFECTS
• There are no known side eects for Reliefband® 2.0.
• There are no contraindications for Reliefband® 2.0.
IMPORTANT
Positioning Reliefband® 2.0 properly on your
wrist is essential for relief of your nausea, retching
and vomiting symptoms. Before you start using
Reliefband® 2.0, please read this Instructions For
Use carefully.You must feel a “tingling” sensation in
your palm and/or middle ngers for Reliefband® 2.0
to work.
Reliefband 2.0 must be charged before use.
APPLYING RELIEFBAND® CONDUCTIVITY GEL
Reliefband® Conductivity Gel is an essential
component for use and therapy. Hypoallergenic
Reliefband® Conductivity Gel makes the delivery of
pulses much more ecient.
Note: Reliefband® Conductivity Gel should be
re-applied every 2-3 hours, or any time after washing,
or if stimulation decreases.
1. Power On/O/Intensity Down Button – press and
hold for 1.5 seconds to power on the device. During
active therapy, briey pressing this button will
decrease the intensity. Press and hold for 1.5 seconds
to turn the device o.
2. Intensity Up Button – Once the device has been
turned on, press this button to increase the intensity.
3. Therapy Intensity Level Indicator – 10 levels indicated
by blue illuminated LEDs.
4. Battery/Charging Indicator – four blue illuminated LED
segments indicate charge level. A single ashing red
segment indicates 15% or less battery life remaining.
5. Therapy On Indicator – pulsing blue LEDs indicate the
device is delivering therapy.
6. Hypoallergenic Contacts – 316L Stainless Steel,
therapy is delivered here.
7. Charging Port – attach the magnetic charging cable
here to recharge the device.
8. Latch – locks the Simple Band (11) tight to hold the
device in position.
9. Cinch Bar – gently pull the Simple Band (11) against
the Cinch Bar to achieve a snug t on the wrist.
10. Smart Band – unique shape holds the device in place
and makes it easy to put on and take o.
11. Simple Band – slide through the latch to adjust the t
to your wrist.
12. Contact Assembly – houses the contacts that deliver
therapy.
13. Magnetic Connector – attaches charging cable to the
device.
14. USB Charging Cable
1. Ensure Reliefband 2.0 is turned o prior to charging.
Do not wear while charging.
2. Plug the USB Charging Cable (14) into any standard
USB charging port.
3. Attach the Magnetic Connector (13) end of the USB
Charging Cable (14) to the Charging Port (7) on the
body of the Reliefband® 2.0 device.
4. Blue LEDs segment(s) will ash when in charging mode:
a. 1 LED segment = 1% - 25% charged
b. 2 LED segments = 26% - 50% charged
c. 3 LED segments = 51% - 75% charged
d. 4 LED segments = 76% - 100% charged
5. Full charge is indicated when all four blue LED
segments remain constantly illuminated. Typically,
it takes about 75 minutes to reach full charge.
A 15-minute charge will give about 6 hours of
continuous use at the mid-power level or below.
6. When turning the device on, the Battery Charge
Indicator (4) will indicate how much charge is left in
the device.
7. A single ashing red LED segment indicates 15% or
less battery life remaining.
INTENSITY
UP BUTTON
POWER
ON/OFF/INTENSITY
DOWN BUTTON
3ADJUST
Holding the device by the Contact Assembly, place
the contacts onto the gel over the P6 location on the
underside of the wrist. Fasten device snugly.
4ACTIVATE**
Press and hold the Power ON/OFF/Intensity Down
Button (-) for 1.5 seconds to turn on or o.
Press the intensity Up Button (+) once to set
stimulation to level 1. Increase intensity until tingling
is felt in palm and middle ngers.
Set to the highest comfortable setting for maximum
benet.
**Please charge for at least 1.5 hours before initial use.
(13) MAGNETIC CONNECTOR
(14)
USB CHARGING CABLE
STANDARD USB CHARGING PORT
OR UL APPROVED (5V) CHARGER.
(4) BATTERY/CHARGING INDICATOR
(7) CHARGING PORT
(a.) 1 LED (b.) 2 LEDs
SINGLE FLASHING RED LED
- LOW BATTERY
(c.) 3 LEDs (d.)4 LEDs - FULLY CHARGED

FCC INFORMATION:
This device complies with Part 15 of the FCC Rules.
Operation is subject to the following 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.
MAINTENANCE:
Keep the contacts area clean. Periodically examine the
contacts for gel build-up around the perimeter of the
contacts, which may interfere with or decrease the
delivery of therapy. A moist cloth or cotton swab may
be used to remove any gel build-up. Avoid immersion
of the device in liquid. Reliefband® 2.0 must not be
opened or altered in any way.
ENVIRONMENTAL USE INFORMATION:
Reliefband® 2.0 should only be used within the
environmental ranges of 0°C to 45°C (32°F to
113°F) and 20% to 90% relative humidity (non-
condensing).
1. Turn the product to ON by pressing and holding
the Power On/O/Intensity Down Button (1) for
1.5 seconds
a. Upon powering on, the Intensity Level
Indicator LEDs (3) will illuminate in
sequence of 1-10, then back down to level 0.
b. The current battery charge is displayed for
1.5 seconds before fading away.
2. Press the Intensity Up Button (2) once to set
stimulation to the rst level. At this point
therapy is being delivered. If intensity level is
not set, Reliefband 2.0 will turn o.
a. Blue LED intensity lights will indicate
intensity level:
i. No LEDs illuminated = Level 0 =
Power ON but no therapy
ii. 1 LED illuminated = Level 1 Therapy
iii.10 LED’s illuminated = Level 10 Therapy
b. The Therapy On Indicator (5) will pulse
on and o indicating that the device is
delivering therapy.
Size Rectangular shape – max case
dimensions: 14.5mm H x 23.5mm W x
4.1mm L, with Smart Band and Simple
Band.
Weight Approximately 50 grams
User Controls Two Push Buttons: On/O/Intensity Down
and Intensity Up
User Display Blue LED logo ( ) pulsing means device
is providing therapy.Ten diagonal blue
LED bars indicate therapy power level.
Four circular blue LED segments indicate
battery charge level.
Low Battery When battery level registers 15% or less,
a single LED segment will switch from
static blue to ashing red.
Output
Channels
Two hypoallergenic surgical grade (316L)
stainless steel contacts.
Maximum
Output
40mA
USB Charging
Cable
1m length cable with custom magnetic
connector
Battery Rechargeable Li-Ion Polymer - IEC62133
standard. Battery life is approximately
three years or 500 charge cycles.
The Troubleshooting Chart below will help to assist
you in handling situations that may arise while you
use the product.
Situation Recommended Solution
Blue intensity
LEDs and
pulsing blue
Therapy On
LEDs are
illuminated but
no stimulation is
felt
Move the contacts around the underside
of the wrist to ensure proper placement.
Increase the intensity using the Intensity
Up Button (2). Re-apply a small amount of
Reliefband Conductivity Gel. Ensure gel
is rubbed into a sheen. Be sure the strap
is secure around the wrist. Be sure blue
Intensity LEDs (3) are illuminated at one
of the ten intensity settings.
No LEDs
Illuminated
Briey press the Intensity On/O/Down
button (1) once to check if device is
powered on. If power is on, the blue
Intensity LED bars (3), the Battery/Charging
Indicator segments (4) and the Therapy On
Indicator (5) will ash. If nothing ashes,
the device may be o. Press and hold the
Intensity On/O/Down button for 1.5
seconds to wake up the device. If no LEDs
ash, the battery may be drained. To charge
the battery - see the "Charging The Battery"
section.
Flashing red,
low battery LED
illuminated
This indicates a low battery and 15% (2.4
hours at level 5) or less of charge remains.
Recharge the battery as soon as possible
– see "Charging The Battery" section
Model: Reliefband® 2.0
Reliefband® Technologies warrants each new Reliefband®
2.0 to be free from material defect in workmanship and
materials for sixty (60) days from the date of purchase,
the “Warranty Period.”This limited warranty is subject
to (a) the customer notifying Reliefband® Technologies
within sixty (60) days of the date of purchase of any
material defect in Reliefband® 2.0 workmanship and
materials (“Defective Product”) during the Warranty
Period, and (b) the customer returning the Defective
Product to Reliefband® Technologies. Contact Reliefband®
Technologies at 877-735-2263 for return or replacement
of Defective Product.
Reliefband® 2.0 is indicated for nonprescription (over-the-
counter) use in relief of nausea, retching and vomiting
due to motion sickness, morning sickness associated with
3. Adjust intensity level using the Intensity Up
Button (2) until a "tingling" sensation is felt in
the palm or middle ngers of your hand.
4. If no “tingling” is felt, increase the intensity using
the Intensity Up Button (2).
5. If "tingling" is still not felt, check the position
of the Hypoallergenic Contacts (6) and adjust
until you feel "tingling" in your palm and middle
ngers.
6. Press and hold the Power On/O/Intensity Down
Button (1) for 1.5 seconds to turn the device o.
7. If the battery charge has depleted, recharge
the device according to "Charging The Device"
instructions.
a. Once battery level registers 15% or below,
the single LED will switch from static blue
to ashing red.
b. A ashing red LED indicates the device will
require charging as soon as possible.
ENVIRONMENTAL STORAGE INFORMATION:
The device can be stored and transported in the
environmental ranges of 0°C to 27°C (32°F to
80°F) and 20% to 80% relative humidity (non-
condensing). If the device has been stored or
transported in conditions outside this range, keep
it within the normal ranges for at least 30 minutes
before using.
DISPOSAL INFORMATION
Reliefband 2.0 is not regulated as hazardous
goods. It can be recycled or disposed with normal
household trash.
TECHNICAL INFORMATION
Reliefband complies with:
• IEC 60601-1:2005+A1:2012/EN 60601-1:2006
Medical electrical equipment - Part 1: General
requirements for basic safety and essential
performance
• IEC 60601-1-2:2007/EN 60601-1-2:2007 Medical
electrical equipment - Part 1-2: General
requirements for safety - Collateral standard:
Electromagnetic compatibility - Requirements
and tests
TIPS FOR EFFECTIVE USE
• Reliefband® 2.0 can be worn on either wrist provided tingling is
felt in the palm and/or middle ngers.
• For some people, applying and rubbing in the gel twice assists
in nerve stimulation.
• Reliefband® Conductivity Gel should be re-applied every 2-3
hours during use, any time after washing, or if stimulation
decreases.
• Contact with skin for prolonged periods may contribute to skin
irritation particularly for users who have allergies. To reduce
irritation, follow three simple wear and care tips: (1) Keep it
clean; (2) keep it dry; and (3) after extended wear, give your
wrist a rest by removing the band for an hour.
• Regularly clean your Reliefband 2.0 and wrist—especially
if perspiring, or before reapplying conductivity gel – before
returning the Reliefband to your wrist. Wipe the band and
contacts with a clean, damp wipe using water or a small
amount of rubbing alcohol. Do NOT use hand soap, body
soap, dish soap, hand sanitizers, cleaning wipes or household
cleaners which could get trapped beneath the band and
irritate skin. Always dry the band well before putting it back on.
• To remove build-up of lotions and oils (such as sunscreen,
insect repellent and moisturizers) that can be trapped beneath
the band, we recommend that you use a soap-free cleanser like
Cetaphil Gentle Skin Cleanser or Aquanil; wipe o thoroughly,
and dry well.
• While still on the wrist, turn Reliefband® 2.0 o periodically
to determine if you still have nausea, retching and vomiting
symptoms. If you still have symptoms, then turn it back on
immediately.
pregnancy, chemotherapy and postoperative nausea.
Reliefband® 2.0 may not be eective for every person
because treatment outcomes vary and are dependent
upon a myriad of patient proles and characteristics.
Reliefband® Technologies’obligation under this Limited
Warranty is expressly limited solely and exclusively to the
replacement of the Defective Product.
THE LIMITED REPRESENTATIONS ANDWARRANTIES
SET FORTH HEREIN ARE RELIEFBAND TECHNOLOGIES’
SOLE REPRESENTATIONS AND WARRANTIES WITH
RESPECT TO THE 2.0 OR ANY OTHER SUBJECT MATTER
HEREOF AND ARE GIVEN IN LIEU OF ANY AND ALL
OTHER REPRESENTATIONS OR WARRANTIES, WHETHER
EXPRESS OR IMPLIED, INCLUDING,WITHOUT LIMITATION,
ANY IMPLIED WARRANTIES OF MERCHANTABILITY OR
SUITABILITY FOR A PARTICULAR PURPOSE. THE REMEDIES
AFFORDED TO CUSTOMER FOR ANY BREACH OF
WARRANTY WILL BE LIMITEDTO THOSE SET FORTH HEREIN
TO THE EXCLUSION OF ANY AND ALL OTHER REMEDIES.
CUSTOMER WILL NOT BE ENTITLED TO PUNITIVE,
INCIDENTAL, CONSEQUENTIAL OR SPECIAL DAMAGES,
INCLUDING WITHOUT LIMITATION CUSTOMER’S DENTAL
AND MEDICAL COSTS, AS A RESULT OF A DEFECTIVE
PRODUCT. NO AGREEMENT VARYING OR EXTENDING
THE FOREGOING WARRANTIES, REMEDIES OR THIS
LIMITATIONWILL BE BINDING ON EITHER PARTY UNLESS
MEMORIALIZED IN A WRITING SIGNED BY BOTH PARTIES.
Some jurisdictions do not allow the exclusion or limitation
of special, indirect, incidental or consequential damages,
so the above limitation or exclusion may not apply to you.
INSTRUCTIONS FOR USE
Model: Reliefband® 2.0
DRUG-FREE RELIEF
FROM NAUSEA, RETCHING AND VOMITING
2.0
DETAILED OPERATION TECHNICAL DATA
TROUBLESHOOTING
STORAGE AND USAGE
INFORMATION
LIMITED WARRANTY
STATEMENT
(2)
INTENSITY UP
BUTTON
(1)
POWER ON/OFF/INTENSITY
DOWN BUTTON
(3)
INTENSITY LEVEL
INDICATOR
(5)
THERAPY ON
INDICATOR
(6)
CONTACTS
YOU SHOULD FEEL A
"TINGLIN G" SENSATION IN THE
PALM OR MIDDLE FINGERS.
SINGLE FLASHING
RED LED
- LOW BATTERY
Reliefband® 2.0 produces
physiological eects as described in this
guide.
Reliefband® 2.0 is classied as a
TYPE BF Applied Part
Latex Free
Reliefband® 2.0 is splash-resistant
ATTENTION
IPX4
For European Union: Environmental Protection
Waste electrical products should not be
disposed of with household waste. Please
recycle where facilities exist. Check with
your Local Authority or retailer for recycling
advice.
California Only: Percholorate Material -
Special handling may apply. See
www.dtsc.ca.gov/hazardouswaste/perchlorate
This warranty shall not apply to any Defective Product
that has been tampered with or repaired and/or altered
by someone other than a duly-authorized Reliefband
Technologies’ representative. Further, this warranty shall
not apply to any Defective Product where the defect has
been caused by customer negligence, mishandling or
any customer use contrary to the enclosed instructions or
customer use inconsistent with the stated purpose.
This warranty is expressly limited solely to the original
purchaser and does not extend or confer any rights to
any transferee, assignee, or subsequent purchaser or user
of a Defective Product. Reliefband® Technologies’ liability
for all claims, (whether based on contract, tort, breach of
warranty, or otherwise), which may arise in connection
with the purchase and use of any Defective Product
is limited to the purchase price paid by the original
purchaser.
6006980 Rev. B
• IEC 60601-2-10:2012/EN 60601-2-
10:2000+A1:2001 Medical electrical equipment
- Part 2-10: Particular requirements for the safety
of nerve and muscle stimulators
• When nished using Reliefband® 2.0 take it o your wrist.
Remove the gel from your wrist and the device with a tissue.
• When not using Reliefband® 2.0 be sure to turn the power o
to extend battery life.
• Store Reliefband® 2.0 in a safe, dry place. Keep it away from
young children.
• Avoid an excessive amount of gel; it could decrease the ecacy
of the device.
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