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  9. Reliefband Technologies RB-EL User manual

Reliefband Technologies RB-EL User manual

INDICATIONS FOR USE: Reliefband®is a digital therapeutic device that is indicated for use in the
relief of nausea and vomiting due to travel/motion sickness and pregnancy/morning sickness.
IMPORTANT: Positioning Reliefband®properly on your wrist is essential for relief of your
nausea and vomiting symptoms. Before you start using Reliefband®, please read this Instructions for
Use carefully. You must feel stimulation in your palm and/or middle ngers for Reliefband®to work.
CONTENTS: (1) Reliefband®Model RB-EL, (1) Preinstalled Batteries (Replaceable), (1) Hypo-allergenic
conductivity gel tube and (1) Instructions for Use.
DESCRIPTION OF RELIEFBAND: Reliefband®is a digital therapeutic device incorporated into a
wristband worn on the underside of the wrist. It provides relief from nausea and vomiting due to
motion sickness and morning sickness through gentle electrical stimulation of the nerves in your
wrist. Batteries will last approximately 150 hours of active use at power level 3 or below. The
batteries of Reliefband®are user replaceable. Replace batteries in unit when they become drained.
SAFETY INFORMATION
WARNINGS:
CAUTION:
SIDE EFFECTS:
Pacemaker users - Use this device only as directed on the wrist to prevent possible interference
with your pacemaker. Avoid placing the electrodes directly on your chest or near the pacemaker.
Nausea and vomiting may be signs of a serious health problem. Contact a doctor if your nausea
and vomiting seem to be lasting a long time.
Do not use Reliefband®when the cause of nausea and vomiting symptoms is undiagnosed
because those symptoms might be an important indicator of more severe health problems.
Reliefband®should only be used on the wrist. Do not use it on any other areas of the body
because the device might cause undesirable eects such as tingling, muscle twitching or skin
irritation.
Reliefband®does not cure the underlying causes of nausea and vomiting. The relief you get may
vary depending on your body’s individual characteristics and any medications that you may be
taking that could cause your body to respond dierently.
Reliefband®should be kept out of reach of young children.
If you are unable to tolerate any food or liquids or are having
weight loss you should contact your doctor.
Reliefband®is splash-resistant. This product is resistant to splashing water (rain, waves, etc). Do
not immerse Reliefband®in water or wear while bathing. Reliefband®is also shock resistant.
The elastic strap contains natural rubber latex which may cause allergic reactions.
For some people, skin irritation (red or itchy skin, red bumps or small blisters) may occur
beneath or around the gold plates on the back of the device (electrodes). If skin irritation occurs
beneath or around the electrode sites, move the device to the other wrist. If irritation does not
disappear within 24 hours, stop using the device and consult your doctor or pharmacist.
Continued use of the device on irritated skin may cause skin injury.
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 electrode area clean. A moist cloth may be used to remove gel
build-up, which may decrease stimulation. Avoid immersion of the device in water.
To purchase additional Reliefband®’s or accessory items, including conductivity gel, call
1-877-735-2263.
ENVIRONMENTAL USE INFORMATION:
Reliefband®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).
220 Gibraltar Road, Suite 270, Horsham, PA 19044
Reliefband® is a registered trademark of Reliefband Technologies. Reliefband®
technology is protected by US Patent No. 6,076,018; 6,567,695; 6,735,480; 7,127,288; 7,171,266. Japan Patent No.
4,168,380; 4,812,810; 4,220,129. UK Patent No. 1,109,595; Canadian Patent No. 2,449,554; 2,429,677. Designed in
USA, MFD in Malaysia. Manufactured for Reliefband Technologies. ©2016 Reliefband Technologies
In the U.S.A., call 1-877-735-2263 9:00 AM - 5:00 PM Mon. - Fri. CST 6006820 Rev. C
EMERGO EUROPE
Molenstraat 15
2513 BH, The Hague
The Netherlands
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: The product and batteries do not contain any environmentally
hazardous substances and can be disposed of normally. The batteries used in this device
may explode if mistreated. Do not recharge, disassemble or dispose of them in re.
No modication of this device is allowed.
TECHNICAL INFORMATION: Reliefband®complies with IEC 60601-1:2005 +Corr.1 (2006)
+Corr. (2007); CAN/CSA-C22.2 No. 60601-1 (2008), EN 60601-1:2006 +CORR:2010, and
ANSI/AAMI ES60601-1 (2005 + C1:09 + A2:10). Reliefband®has been veried as a class B Digital
device per FCC 47 CFR, Part 15 Subpart B and has been found to comply with the following
Electromagnetic Compatibility standards: EN55011 (CISPR 11).
Radiated Emission: EN61000-4-2 Electrostatic Discharge Immunity; ENV 50204 and EN
61000-4-3 Radiated Electromagnetic Field Immunity.
Reliefband®is classied as
TYPE B equipment.
Attention, Reliefband®produces physiological
eects as described in this guide.
Reliefband®is splash resistant.
California Only: Perchlorate Material –
Special handling may apply. See www.dtsc.ca.gov/hazardouswaste/perchlorate.
This product contains natural rubber latex, which may cause
allergic reactions.
Size
Weight
User Controls
User Displays
Low Battery
Output Channels
Maximum Output
Battery
TECHNICAL DATA
Teardrop shape 1.5”x 2”x 0.45”
(3.81 x 5.08 x 1.14 cm)
Approximately 1.2 ounces (34 grams)
Push Button
On: Flashing Green LED at Power Level
Flashing light indicator (see gure 1)
Two electrodes
35mA
Two 3V lithium coin cell batteries (CR2025’s)
Toshiba or Panasonic
User replaceable, not rechargeable
QUESTIONS AND ANSWERS
When to use Reliefband®?
You can use your Reliefband®either before or after your nausea and vomiting symptoms
start, and leave it on for as long as your symptoms last. If you are highly susceptible to
motion sickness, apply Reliefband®one half hour before a motion sickness event (e.g.,
riding in a car, airplane or boat).
How can I be sure I’ve found the area for maximum stimulation?
After the device is turned on, move it slightly up or down, and side to side on the wrist
until the maximum “tingling”feeling is felt. You will feel a tingling sensation in your palm
and/or middle ngers
when Reliefband®is in the proper wrist location.
Stimulation will cycle every four seconds.
If little or no tingling is felt after moving it around, increase the power level to the next
level of stimulation. This device has ve levels of stimulation: 1, 2, 3, 4 and 5 (level 5 is the
highest setting).
Try the band on the opposite wrist. Use it on the wrist where you feel the most tingling.
Increase the power setting to the highest comfortable setting for maximum relief.
On which wrist should I wear Reliefband®?
On the wrist that gives you the greatest tingling in the hand at the lowest stimulation level.
Is dry or sensitive skin a problem?
For dry skin, the gel may be lightly applied more often. If you have especially sensitive skin,
switch wrists every 2-3 hours. Be sure to re-apply gel as directed.
How long will the batteries last?
The batteries should last for about 150 hours of total use at power level 3, less time at higher
power levels. Battery life depends on individual usage of product and brand of batteries.
There are many dierent brands of batteries, each giving somewhat dierent battery life
performance. Some batteries last a long time for occasional use, other batteries last longer for
more frequent use. Try dierent brands to determine which brand works best for how you use the
device.
How do I know when the batteries are getting low?
The low battery light on the display will ash slowly to let you know when the batteries are low. At
this time, about 10 hours use remains depending on the power level used and how long you have
used the device.
Green Light Flashing (No stimulation is felt)
Move Reliefband® around the underside of the wrist. Check for proper placement. Increase the
power setting. Re-apply a small amount of gel. Be sure gel is rubbed in to sheen. The area should
appear shiny. Be sure the strap is secure around the wrist. Be sure green light is ashing at one of
the 5 power settings.
No Lights Flashing
Check that device is on. You should see green ashing light at one of the 5 power settings (1-5).
Turn device OFF and reactivate. Batteries may be drained (see disposal information section).
How can I be sure Reliefband® stays in place at night?
For additional FAQ, please see www.reliefband.com
Situation Recommended Solution
TROUBLE SHOOTING
In general, if you are sleeping comfortably, you most likely do not need to wear the device while
sleeping. If you do need the device on to control symptoms while sleeping, then it may help to
secure Reliefband® in place by using strips of medical tape or an ace bandage to secure it in place.
Reliefband® has been designed to provide feedback to ensure proper usage to relieve nausea and
vomiting symptoms. The Troubleshooting Chart below will help to assist you in handling situations
that may arise while you use the product.
Green Light Flashing
(No Stimulation is felt)
Move Reliefband® around the underside of the wrist. Check for
proper placement. Increase the power setting. Re-apply a small
amount of gel. Be sure gel is rubbed into a sheen. The area should
appear shiny. Be sure the strap is secure around wrist. Be sure green
light is ashing at one of the 5 power settings.
No Lights Flashing Check that device is on. You should see green ashing light at one
of the 5 power settings (1-5). Turn device OFF and reactivate.
Batteries may be drained (see disposal Information section).
Low battery light ashing The ashing light indicator (see gure 1) indicates a low battery.
Restart unit to see if power remains. Set the unit at a lower setting.
If the ashing light continues to ash, the batteries are running out
of power.
Reliefband® Technologies warrants each new Reliefband®to be free from defect in material and
workmanship for 30 days from date of purchase, exclusive of batteries. All other warranties, express
and implied, are limited to 30 days from the date of purchase.
Reliefband®is indicated for nonprescription (over-the-counter) use in relief of nausea and vomiting
due to motion sickness and morning sickness. Reliefband®is not warranted to be eective in every
case since relief varies dependent upon user characteristics.
Reliefband®Technologies’s obligation under this Limited Warranty is expressly limited solely and
exclusively to the replacement of the unit to which Reliefband®Technologies’satisfaction is defective.
Contact Reliefband®Technologies at 877-735-2263 for replacement within 30 days after date of
purchase as indicated on the sales receipt. Some States do not allow limitations on how long an
implied warranty lasts, so the above limitation may not apply to you.
This warranty does not extend to any liability for medical or dental expenses or for any other direct,
indirect or consequential damages caused by failure, defect or malfunction of any Reliefband®except
as herein provided, whether such damage claim shall be based on contract, tort, breach of warranty,
or otherwise. Some States do not allow the exclusion or limitation of incidental or consequential
damages, so the above limitation may not apply to you.
This warranty shall not apply to any Reliefband®which has been repaired, tampered with, or altered
by someone other than a duly authorized Reliefband®Technologies representative, nor to any
Reliefband®which has been subjected to negligence, accident, mishandling or which has not been
used in accordance with the enclosed instructions or for the stated purposes.
This warranty is expressly limited solely to the original purchaser (consumer) and does not extend to
any transferee, assignee, or subsequent purchaser or user of any Reliefband®. 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 Reliefband®is limited to the purchase price paid
by the original purchaser therefor. This warranty gives you specic legal rights, and you may also have
other rights which vary from State to State.
LIMITED WARRANTY STATEMENT - Reliefband®Model No. RB-EL
1.
2.
3.
4.
Replacing the Batteries:
A low battery indicator (see Figure 4 at the top of the page) ashes when the batteries are
low. (Approximately 10 hours of use remain depending on the power level used.)
Peel back the rubberized battery door at the end marked “OPEN HERE” (see Figure 5) and
pull out the red colored tray.
Remove used batteries and then replace them with two fresh batteries (3V, CR2025 Lithium
coin cells only) available at grocery, drug, and other similar stores.
IMPORTANT: Make sure the new batteries are inserted in the correct direction with the “+”
side down (see Figure 6), the battery tray is inserted correctly, and the door is closed. Be
sure the door is replaced with the“OPEN HERE” facing in original position and there are no
gaps in the seal (gaps decrease water resistance). Never insert an empty battery tray into
the ReliefBand. Doing so may damage the device.
Features and Components
ELASTIC
KEEPER
(BELT LOOP)
LOW BATTERY
INDICATOR
POWER LEVELS
(1-5)
POWER BUTTON
BATTERY DOOR
ADJUSTABLE
NYLON STRAP
Press to turn ON
Press again to increase
to the next level
Press and hold for 3 to 5
seconds to turn OFF
Figure 1
1.
2.
3.
4.
5.
6.
7.
Usage Tips:
Try Reliefband® on each wrist and use it on the wrist where the greatest tingling is felt at
the lowest setting.
For some people, applying and rubbing in the gel twice assists in nerve stimulation.
Gel should be re-applied every 2-3 hours, any time after washing, or if stimulation
decreases.
While still on the wrist, turn Reliefband o periodically to determine if you still have nausea
and vomiting symptoms. If you still have symptoms, then turn it back on immediately.
When nished using the ReliefBand, take it o your wrist and remove the gel from your
wrist and the device with a tissue.
When not using Reliefband, be sure to turn the power o to extend battery life.
Store Reliefband in a safe, dry place. Keep it away from young children.
1.
2.
3.
4.
5.
6.
If you have diculty closing the battery door, we recommend you consider the
following steps:
Make sure that the red battery tray is inserted properly into the device.
Make sure that the thin blue strip (left end of the battery door) is inside the device.
Push left side of blue battery door until snuggly inserted into the left lip of the opening.
Working from left to right, tuck the top part of the door into the device, and lock in right side
of the door.
Working from left to right, tuck bottom lip of the battery door into the device.
If the battery door still sticks out, roll the battery door (while tucked into the device) on a
hard at surface to atten battery door into the device about 5 0r 6 times to secure the
battery door.
Place the device over the gelled area and
attach it to the wrist.
Fasten device snugly. Press “ “ symbol on
center of device to turn on. Starting at power
level 1, increase stimulation until tingling is
felt through median nerve distribution in
palm and middle nger at a comfortable level.
Press“ “ symbol for 3 seconds to turn o.
Fast Nausea Relief
Associated with General Nausea,
Motion Sickness and Morning Sickness
HOW DOES IT WORK?
1 2 3
1 2 3
Reliefband® generates a proprietary pulse
from the underside of the device that
stimulates the median nerve which is located
under the skin near the wrist.
The signals generated by Reliefband® which
are transmitted through the skin to the
median nerve then travel through the body’s
nervous system to the part of the brain
which controls nausea and vomiting.
The pulses have a rebalancing eect,
normalizing nerve messages from the brain
to the stomach and reducing symptoms of
nausea and vomiting.
HOW TO USE RELIEFBAND®
AREA APPLY ADJUST & ACTIVATE
Find the starting area on the wrist.
Using either wrist, the correct area is in
between the two tendons on the underside
of the wrist – two nger widths from the
second crease in the wrist (nearest your
elbow).
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).

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