ENVIRONMENTAL USE INFORMATION:
The device can be stored and transported in the
environmental ranges of: 0°C to 50°C (32°F to 122°F) and
20% to 90% 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.
ENVIRONMENTAL STORAGE INFORMATION
0°C
50°C
90%
20%
20%
90%
10°C
45°C
Reliefband Technologies, LLC, 220 Gibraltar Road, Horsham, PA 19044, USAReletex
®
is a trademark of
Reliefband Technologies, LLC. US Patent No. 6,735,480, Canadian Patent No. 1,319,174, European
Patent No. 05000552. Designed in USA, Manufactured in Malaysia
For Customer Service: In the U.S.A call: (877) 735-2263
9:00 AM - 5:00 PM Mon - Fri CST
IMPORTANT:
Correct positioning of the Reletex® is important to achieve results. The position of Reletex®
on the wrist area should be adjusted until stimulation is felt. A tingling sensation in the palm and/or
middle fingers indicates that the device is correctly positioned on the underside of the wrist. Beginning at
the lowest power level (1), increase the power level until stimulation is felt consistently and comfortably.
Stimulation MUST be felt in the palm and/or middle fingers for Reletex® to provide relief.
Reletex® is classified as TYPE B equipment
.
Reletex® is splash-resistant.
Attention: Reletex® produces physiological effects as described in this guide.
Reletex® is designed to function for approximately 150 hours when used on setting 3. Actual
battery life will vary depending on patient usage. The low battery indicator will signal that
the batteries are low. Dispose of the device when batteries are depleted.
©2016 Reliefband Technologies.
6003410 Rev. G
DESCRIPTION: Reletex® is a prescription transdermal neuromodulation device that is applied to the
underside of the wrist. Reletex® emits electrical pulses that stimulate the underlying median nerve. The
nerve signals generated on the wrist flow to the central nervous system where they work – via the vagus
nerve – to normalize stomach rhythms that cause nausea. It is intended for use as (1) an adjunct to
antiemetics in reducing post-operative nausea; (2) a treatment of nausea and vomiting due to pregnancy
(NVP) or morning sickness; and (3) a treatment of nausea and vomiting (NV) due to chemotherapy
(intended for delivery of up to 150-hour therapy). Reletex® can function with its included set of
non-replaceable/non-rechargeable batteries for approximately 150 hours when used on setting 3.
Press and hold down the Power Button (in the center of the device) for three (3) seconds.
Reletex® should only be used on the designated area.
Do not use Reletex® when the cause of nausea and vomiting symptoms is undiagnosed.
Nausea and vomiting are serious medical conditions; seek medical attention if symptoms continue.
Reletex® is not a curative and should always be used under medical supervision. Treatment outcome
may vary depending on patient characteristics and use of concomitant medications.
Reletex® should be kept out of reach of children.
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. Consult
with your physician if you have any other implanted devices.
Reletex® should not be used above an IV line attached to a patient’s arm. If a patient is using an IV line,
Reletex® should be placed on the opposite arm.
Isolated cases of skin irritation may occur where the electrodes touch the skin following long term
application. Continued use of the device on irritated skin may cause injury.
If local skin irritation (redness, swelling, blotches, blisters or itching on the wrist under the device)
occurs, then discontinue use. If irritation does not resolve within 24 hours, then consult your doctor or
other healthcare professional.
MAINTENANCE: Keep the electrode area on Reletex® clean. A damp cloth or alcohol wipe may be used.
Do not put the device in water.
LOW BATTERY WARNING: Low battery indicator flashes when the batteries are low. Dispose device
according to your local state/country laws
California Only: Perchlorate Material - Special handling may apply.
See www.dtsc.ca.gov/hazardouswaste/perchlorate.
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
Flashing light indicator
Flashing Red light indicator (See Figure 5)
Two electrodes
40mA (nominal)
Two 3V lithium coin cells
Not replaceable, not rechargeable
TECHNICAL DATA
WARNINGS
SIDE EFFECTS
INTENDED USES:
Reletex® from Reliefband® is a prescription device indicated for use as: (1) An adjunct to
antiemetics in reducing post-operative nausea; (2) Treatment of nausea and vomiting due to pregnancy
(NVP) or morning sickness; and (3) Treatment of nausea and vomiting (NV) due to chemotherapy (intended
for up to 150-hour therapy). In all such instances, Reletex® is for single-patient use.
CAUTION:
Federal Law (USA) restricts this device to sale by or on the order of, a physician or other
health care professional licensed in the state in which they practice.
CONTENTS: (1) Reletex®, (1) Hypo-allergenic conductivity gel tube, and Instructions for Use.
How can I be sure I’ve found the area for maximum stimulation?
After the device is turned on, adjust the positioning of the device on the wrist by moving it
slightly up or down, and side-to-side until the maximum “tingling” feeling is felt. You will feel
this tingling sensation in your palm and/or middle fingers when Reletex® is in the proper
position. Stimulation will cycle every four seconds.
If little or no tingling is felt, then read just the position of the device on the wrist and/or increase
the power level. This device has five levels of stimulation: 1, 2, 3, 4 and 5 (level 5 is the highest
setting). If you are at level 5 and do not feel stimulation, curl your fingers slightly and turn the
hand inward (thumb towards your body). If the stimulation increases, tighten the band at that
point.
If you are unable to feel the tingling on one wrist, then try the band on the opposite wrist. Use it
on the wrist where you feel the most tingling.
Re-apply gel as directed.
On which wrist should I wear the Reletex®?
How do I turn off the Reletex®?
On the wrist that gives you the greatest tingling feeling at the lowest stimulation level.
QUESTIONS & ANSWERS
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 desired.
How can I be sure the Reletex® stays in place at night?
It may help to secure Reletex® in place by using strips of medical tape or a bandage to
secure it over the wrist area while you sleep.
How long will the device remain active?
What if I find a decrease in stimulation after a couple of days use?
Check the electrode area for gel and clean as needed. Only apply enough gel to achieve a
sheen on the skin. Wipe gel from skin and device after each use.
LIMITED WARRANTY STATEMENT Reletex® PCN-3
Reliefband Technologies warrants each new Reletex® (excluding the batteries) to be free from defect in
material and workmanship for 60 days. All other warranties, express and implied, are limited to 60 days
from the date of purchase. Reletex® is intended for use as (1) An adjunct to antiemetics in reducing
post-operative nausea (PON), (2) Treatment of nausea and vomiting due to pregnancy (NVP) or morning
sickness; and (3) Treatment of nausea and vomiting (NV) due to chemotherapy. Reletex® is not
warranted to be effective in every case since treatment outcome varies dependent upon patient
characteristics. The obligation of Reliefband Technologies LLC 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. 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 Reletex® except as herein provided, whether
such damage claim shall be based on contract, tort, breach or 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 Reletex® which has been repaired, tampered
with or altered by someone other than a duty authorized Reliefband Technologies representative, nor
to any Reletex® 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 Reletex®. 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 Reletex® is limited to the purchase price paid by the original purchaser
therefor. This warranty gives you specific legal rights, and you may also have other rights which vary
from state to state.
Size . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Weight . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
User Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
On/Power Level . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Low Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Output Channels . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Maximum output . . . . . . . . . . . . . . . . . . . . . . . . . .
Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Radiated Emissions: EN 61000-4-2 Electrostatic Discharge Immunity; ENV 50204 and EN 61000-4-3
Radiated Electromagnetic Field Immunity.
EMERGO EUROPE
Molenstraat 15
2513 BH, The Hague
The Netherlands
t e c h n o l o g i e s
reliefband
®
Reletex® should only be used within the environmental ranges
of: 10°C to 45°C (50°F to 113°F) and 20% to 90% relative
humidity (non-condensing).
CAUTION: The batteries used in this device may explode if mistreated. Do not recharge, disassemble,
or dispose in fire.
The device and batteries do not contain any environmentally hazardous substances and can be disposed of
normally following your local/countries laws.
Device is not recommended for use in conjunction with electrocautery or MRI equipment.
No modification of this device is allowed.
FCC INFORMATION: This device complies with Part 15 of the FCC Rules. Operation is subject to the
following two 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.
SAFETY INFORMATION: Reletex® complies with IEC-60601-1 (1988) Medical Electrical equipment, Part 1:
General Requirements for Safety, including Am.No.1 (1991) and Am.No.2 (1995) and EN 60601-1. Reletex™
has been verified 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: EM55011 (CISPR 11).
