Reliefband Technologies 1.5 Indications For Use

INDICATIONS FOR USE: Reliefband® is a digital therapeutic device indicated
for use in the treatment of nausea, retching and vomiting due to motion
sickness, morning sickness associated with pregnancy, and chemotherapy.
Reliefband® is also indicated as an adjunct to antiemetic therapy in reducing
post-operative nausea.
IMPORTANT: Positioning Reliefband® properly on your wrist is
essential for relief of your nausea, retching 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®, (2) 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. Inc.
Reliefband® technology is protected by US Patent Nos. 6,076,018; 7,127,288. Japanese
Patent Nos. 4,812,810; 4,220,129. Canadian Patent Nos. 2,449,554; 2,342,873. Australian
Patent Nos. 766463; 2004200090; 2002305786. European Patent No. 1,109,595-UK,
France and Germany (DE 69940405.3)
Designed in USA. Manufactured in Malaysia. ©2017 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® is a digital therapeutic
device incorporated into a wristband which has a stimulating electrode
that is worn on the underside of the wrist. It provides relief from nausea,
retching and vomiting through gentle electrical stimulation of the median
nerve. 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

CAUTION:
Pacemaker users - Use this device on the wrist and only as directed
to prevent possible interference with your pacemaker. Avoid
placing the electrodes directly on your chest or near the
pacemaker. Consult your doctor before using the device.
Keep the Reliefband® product away from young children as it
contains batteries that should not be swallowed and may pose a
choking hazard.
Nausea, retching and vomiting may be signs of a serious
health problem. Contact a doctor if your nausea, retching and
vomiting persists.
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,
retching 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.
If you are unable to tolerate any food or liquids or are experiencing
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 or showering. Reliefband® is also
shock-resistant.
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.
– Model : Reliefband® 1.5
EMERGO EUROPE
Prinsessegracht 20
2514 AP The Hague
The Netherlands
6006820 Rev. D
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. Gel build-up may decrease stimulation. Avoid
immersion of the device in water.
To purchase additional Reliefband® devices or accessory items, including
conductivity gel, go to Reliefband.com

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).

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 not used or handled
properly. 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 a TYPE BF
Applied Part.
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.

TECHNICAL DATA

Size Teardrop shape 1.5" x 2" x 0.45"
(3.81 x 5.08 x 1.14 cm)
Weight Approximately 1.2 ounces (34 grams)
User Controls Push Button
User Displays On: Flashing Green LED at Power Level
Low Battery Flashing light indicator (see gure 1)
Output Channels Two electrodes
Maximum Output 40mA
Battery Two 3V lithium coin cell batteries (CR2025's)
User replaceable, not rechargeable
Attention, Reliefband® produces
physiological e ects as described in
this guide.