Reliefband Technologies RB-EL 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
nausea and vomiting symptoms. Before you start using Reliefband
Use carefully. You must feel stimulation in your palm and/or middle ngers for Reliefband
CONTENTS: (1) Reliefband
® Model RB-EL, (1) Preinstalled Batteries (Replaceable), (1) Hypo-allergenic
conductivity gel tube and (1) Instructions for Use.
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
DESCRIPTION OF RELIEFBAND: Reliefband
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:
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.
CAUTION:
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
®
The elastic strap contains natural rubber latex which may cause allergic reactions.
SIDE EFFECTS:
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).
properly on your wrist is essential for relief of your
®
® , please read this Instructions for
EMERGO EUROPE
Molenstraat 15
2513 BH, The Hague
The Netherlands
6006820 Rev. C
is a digital therapeutic device incorporated into a
®
is also shock resistant.
®
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.
to work.
®
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
+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
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.
Reliefband is splash resistant.
®
California Only: Perchlorate Material –
Special handling may apply. See www.dtsc.ca.gov/hazardouswaste/perchlorate.
TECHNICAL DATA
Size
Weight
User Controls
User Displays
Low Battery
Output Channels
Maximum Output
Battery
QUESTIONS AND ANSWERS
When to use Reliefband
You can use your Reliefband
start, and leave it on for as long as your symptoms last. If you are highly susceptible to
motion sickness, apply Reliefband
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.
complies with IEC 60601-1:2005 +Corr.1 (2006)
®
® has been veri ed as a class B Digital
Attention, Reliefband
e ects as described in this guide.
This product contains natural rubber latex, which may cause
allergic reactions.
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
?
®
either before or after your nausea and vomiting symptoms
®
® one half hour before a motion sickness event (e.g.,
?
®
produces physiological
®