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Reliefband Premier RB2.0 - User Manual

Reliefband Premier RB2.0
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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® Premier must not
be opened or altered in any way.
ENVIRONMENTAL USE INFORMATION:
Reliefband® Premier should only be used within
the environmental ranges of 0°C to 38°C (32°F to
100°F) and 20% to 90% relative humidity (non-
condensing).
38
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 Premier 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
Cable with custom magnetic connector
Battery Rechargeable Li-Ion Polymer - IEC62133
standard. Battery life is approximately
three years or 500 charge cycles.
Waveform
Characteristics
@500 ohm load
40mA, 22.5V, 31Hz, 350us per pulse
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® Premier
Reliefband® Technologies warrants each new Reliefband®
Premier to be free from material defect in workmanship
and materials for (1 year) from the date of purchase, the
“Warranty Period. This limited warranty is subject to (a)
the customer notifying Reliefband® Technologies within
1 year of the date of purchase of any material defect
in Reliefband® Premier 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® Premier is indicated for nonprescription
(over-the- counter) use in relief of nausea and vomiting
associated with physician-diagnosed migraine, hangover,
anxiety, motion sickness, chemotherapy and morning
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 Premier 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® Premier 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 Premier and wrist—especially
if perspiring, or before reapplying conductivity gel – before
returning the Reliefband Premier 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® Premier o periodically
to determine if you still have nausea and vomiting symptoms.
If you still have symptoms, then turn it back on immediately.
sickness from pregnancy. Reliefband is also indicated as an
adjunct to antiemetics in reducing postoperative nausea.
Reliefband® Premier 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 AND WARRANTIES SET
FORTH HEREIN ARE RELIEFBAND TECHNOLOGIES’ SOLE
REPRESENTATIONS AND WARRANTIES WITH RESPECT
TO THE PREMIER 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 LIMITED TO 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
LIMITATION WILL 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
CLINICALLY PROVEN RELIEF
FOR THE PREVENTION AND TREATMENT OF
NAUSEA AND VOMITING
PREMIER
RB2.0
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
"TINGLING" SENSATION IN THE
PALM OR MIDDLE FINGERS.
SINGLE FLASHING
RED LED
- LOW BATTERY
Reliefband® Premier produces
physiological eects as described in this
guide.
Reliefband® Premier is classied as a
TYPE BF Applied Part
Latex Free
Reliefband® Premier 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
Read these Instructions before using
Reliefband® Premier
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.
P/N 6106980AW 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® Premier take it o your wrist.
Remove the gel from your wrist and the device with a tissue.
When not using Reliefband® Premier be sure to turn the power
o to extend battery life.
Store Reliefband® Premier 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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Question and Answer IconNeed help?

Do you have a question about the Reliefband Premier RB2.0 and is the answer not in the manual?

Summary

Quick Reference Guide

Locating the P6 Area

Find the starting area (P6) on the wrist between the two tendons, about two finger widths above the wrist crease.

Applying the Device

Clean the wrist area first, then apply a small drop of gel and spread it evenly.

Adjusting and Fastening

Place device contacts onto the gel over the P6 location and fasten the device snugly.

Activating the Therapy

Press and hold the power button to turn on, then press the intensity up button to set stimulation.

Introduction and Indications

Product Overview

Reliefband Premier uses clinically proven technology to relieve nausea and vomiting via neural pathways.

Indications for Use

Indicated for nausea and vomiting associated with migraine, hangover, anxiety, motion sickness, and pregnancy.

How Reliefband Premier Works

Pulsed Stimulation

Device delivers pulses to the median nerve at the P6 location on the wrist.

Nerve Signal Transmission

Signals travel via the nervous system to the brain's nausea control center.

Symptom Reduction

Signals create a rebalancing effect, normalizing nerve messages to reduce nausea.

Safety Information

Warnings and Cautions

Includes warnings against modification, cautions for pacemaker users, and general safety advice.

Side Effects and Contraindications

States there are no known side effects or contraindications for Reliefband Premier.

Package Contents and Application

Included Items

Lists the Reliefband Premier device, magnetic USB charging cable, conductivity gel, and instructions.

Important Application Notes

Emphasizes proper wrist positioning and feeling a tingling sensation for effective therapy.

Getting to Know Your Device

Device Component Identification

Identifies and describes each numbered part of the Reliefband Premier device and its function.

Charging the Device

Charging Procedure

Step-by-step instructions on connecting the USB charging cable and charging the device.

Battery Charge Indicators

Explains how blue LED segments indicate charge level and flashing red indicates low battery.

Detailed Operation

Powering On and Intensity Control

Guide on turning the device on, adjusting intensity levels, and understanding therapy indicators.

Troubleshooting Operation Issues

Addresses issues like no tingling sensation felt and low battery status.

Storage and Usage Information

FCC Compliance and Maintenance

Covers FCC rules, device maintenance, contact cleaning, and avoiding immersion in liquid.

Environmental Usage Conditions

Specifies the recommended operating temperature and humidity ranges for the device.

Environmental and Disposal Details

Storage and Transport Environment

Defines acceptable temperature and humidity ranges for storing and transporting the device.

Technical Standards and Disposal

Lists technical compliance standards and provides disposal guidance for the product.

Technical Data

Device Specifications Summary

Details key specifications including size, weight, user controls, display, output, and battery.

Troubleshooting Guide

Resolving Common Issues

Provides solutions for situations like no stimulation felt, no LEDs illuminated, or low battery.

Tips for Effective Use

Usage and Care Recommendations

Offers advice on gel application, cleaning, wearing, and storage for optimal product performance.

Limited Warranty Statement

Warranty Coverage and Claims Process

Outlines the one-year warranty, conditions for claims, and contact information for defective products.

Overview

The Reliefband® Premier is a rechargeable, digital wearable device designed to provide clinically proven relief from nausea and vomiting. It utilizes patented technology to block signals to the brain's nausea center, leveraging the body's natural neural pathways. This device is an over-the-counter solution for nausea and vomiting associated with physician-diagnosed migraine, hangover, anxiety, motion sickness, chemotherapy, and morning sickness from pregnancy. It also serves as an adjunct to antiemetic therapy in reducing postoperative nausea.

Function Description

The Reliefband® Premier operates by delivering proprietary pulses from its contacts to the median nerve at the P6 location on the underside of the wrist. These signals travel through the body's nervous system to the part of the brain responsible for controlling nausea and vomiting. The signals have a rebalancing effect, normalizing nerve messages from the brain to the stomach and thereby reducing symptoms of nausea and vomiting. The device offers 10 intensity levels, indicated by blue illuminated LEDs, allowing users to adjust the stimulation to their comfort level. A "Therapy On Indicator" with pulsing blue LEDs confirms that the device is actively delivering therapy.

Usage Features

To use the Reliefband® Premier, first identify the P6 area on either wrist. This area is located between the two tendons on the underside of the wrist, approximately two finger widths above the wrist crease. Before placing the device, clean the P6 area and apply a small drop of Reliefband® Conductivity Gel, spreading it in a circle about the size of a large coin with an even sheen. The gel is an essential component for efficient pulse delivery.

Once the gel is applied, hold the device by its Contact Assembly and place the contacts onto the gel over the P6 location. Fasten the device snugly to ensure proper contact. The device features a Smart Band with a unique shape that helps hold it in place, and a Simple Band that slides through a latch to adjust the fit to your wrist. A Cinch Bar allows for a snug fit.

To activate the device, press and hold the Power ON/OFF/Intensity Down Button (-) for 1.5 seconds. Upon powering on, the Intensity Level Indicator LEDs will illuminate in a sequence from 1 to 10, then back down to 0, and the current battery charge will be displayed for 1.5 seconds before fading. To begin therapy, press the Intensity Up Button (+) once to set the stimulation to level 1. It is crucial to increase the intensity until a "tingling" sensation is felt in the palm and middle fingers of your hand. If no tingling is felt, adjust the device's position on the wrist and continue increasing the intensity. The goal is to set the device to the highest comfortable setting for maximum benefit. Briefly pressing the Intensity Down Button during active therapy will decrease the intensity. To turn the device off, press and hold the Power ON/OFF/Intensity Down Button for 1.5 seconds.

The Reliefband® Premier is designed for continuous use. A fully charged battery provides approximately 18 hours of continuous use at the mid-power level or below. A 15-minute charge can provide about 6 hours of continuous use. When the battery level drops to 15% or less, a single flashing red LED segment will indicate low battery, prompting the user to recharge. The device should not be worn while charging.

Maintenance Features

Proper maintenance ensures the longevity and effectiveness of the Reliefband® Premier. The contacts area should be kept clean. Periodically, examine the contacts for any gel build-up around their perimeter, as this can interfere with or decrease the delivery of therapy. Any gel build-up can be removed using a moist cloth or cotton swab. It is important to avoid immersing the device in liquid. The Reliefband® Premier is IPX4 splash-resistant, meaning it can withstand splashing water like rain or waves, but it should not be worn while bathing, showering, or swimming, and splashing water should be avoided while charging. The device must not be opened or altered in any way.

For optimal performance and to prevent skin irritation, especially for users with allergies, it is recommended to keep the wrist and the device clean and dry. After extended wear, give your wrist a rest by removing the band for an hour. Regularly clean your Reliefband® Premier and wrist, particularly if perspiring or before reapplying conductivity gel. Wipe the band and contacts with a clean, damp wipe using water or a small amount of rubbing alcohol. Avoid using hand soap, body soap, dish soap, hand sanitizers, cleaning wipes, or household cleaners, as these can get trapped beneath the band and irritate the skin. Always dry the band thoroughly before putting it back on. To remove build-up of lotions and oils (such as sunscreen, insect repellent, and moisturizers) that might get trapped beneath the band, using a soap-free cleanser like Cetaphil Gentle Skin Cleanser or Aquanil is recommended, followed by thorough wiping and drying.

The Reliefband® Conductivity Gel should be re-applied every 2-3 hours during use, any time after washing, or if stimulation decreases. Avoid using an excessive amount of gel, as this could decrease the device's efficacy. When finished using the device, remove it from your wrist and clean off any remaining gel from both your wrist and the device with a tissue. To extend battery life, ensure the power is turned off when not in use. Store the Reliefband® Premier in a safe, dry place, out of reach of young children.

The device is designed to operate within environmental ranges of 0°C to 38°C (32°F to 100°F) and 20% to 90% relative humidity (non-condensing). For storage and transport, the recommended ranges are 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 outside these ranges, it should be kept within the normal ranges for at least 30 minutes before use.

The Reliefband® Premier is not regulated as hazardous goods and can be recycled or disposed of with normal household trash. For European Union users, waste electrical products should be recycled where facilities exist, checking with local authorities or retailers for advice.

Reliefband Premier RB2.0 Specifications

General IconGeneral
Product NameReliefband Premier RB2.0
CategoryPersonal Care Products
Battery LifeUp to 30 hours
Battery TypeRechargeable Lithium-Ion
Power SourceBattery
FDA ClearedYes
Product TypeWearable Device
Intended UseNausea Relief
UsageWorn on the wrist
Water ResistanceIPX7
Wrist Sizes5.5" - 9"
Color OptionsBlack