Voyager IFU WEB DOWNLOAD
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1. The low battery light on the display will flash slowly to let you know when the batteries are low At this time about 10 hours use remain depending on the power level used and how long you have used the device For additional FAQ please see www reliefband com TROUBLESHOOTING The ReliefBand Voyager 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 Situation Recommended Solution Green Light Flashing No stimulation is felt Move the ReliefBand Voyager 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 a sheen The area should appear shiny Be sure the strap is secure around wrist Be sure green light is flashing at one of the 5 power settings Check that device is on You should see green flashing light at one of the 5 power settings 1 5 Turn device OFF and reactivate Batteries may be drained see disposal Information section No Lights Flashing The flashing light indicator see figure 7 indicates a low battery Restart unit to see if power remains Set the unit at a lower setting If the flashing light continues to flash the batteries are running out of power Low battery light flashing LIMITED WARRANTY STATEMENT ReliefBand Voyager Model N2. items including conductivity gel call 1 877 735 2263 45 C Th te ENVIRONMENTAL USE INFORMATION A a The ReliefBand Voyager should only be used within i the environmental ranges of 0 C to 45 C 32 F to 0c A Z 20 113 F and 20 to 90 relative humidity non condensing 27 C D fa ENVIRONMENTAL STORAGE INFORMATION D The device can be stored and transported in the oc re 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 fire No modification of this device is allowed TECHNICAL INFORMATION The ReliefBand Voyager 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 The ReliefBand Voyager 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 EN55011 CISPR 11 Radiated Emission EN61000 4 2 Electrostatic Discharge Immunity ENV 50204 and EN 610
3. where the device should be centered see figure 2 Figure 2 o Apply The Gel 1 For best results clean and dry the area completely see figure 3 Figure 3 Figure 4 2 Place a small drop of conductivity gel on the spot on the wrist identified above see figure 4 Spread the gel in a circle about the size of a quarter Rub in to a sheen Use of too much gel may reduce the intensity of stimulation NOTE The gel should not be rubbed in completely The area should appear shiny Re apply gel as needed see figure 4 to maintain the best quality of sensation about every 2 3 hours If there is excess gel the ReliefBand Voyager may not provide enough tingling If you cannot feel the tingle clean your wrist and the back of the ReliefBand Voyager then re apply the gel You can apply extra gel if the tingle feels too strong on level 1 How to turn on the ReliefBand Voyager Activate the device by pressing the POWER button once see figure 7 This will activate the unit at power level 1 NOTE Power level 1 is the lowest setting and 5 is the highest setting The green light at level 1 will begin to flash indicating the unit is on It also lets you know whether you are on setting 1 2 3 4 or 5 Finding the Stimulation Point CRITICAL STEP 1 With the low battery symbol pointing towards the thumb place the ReliefBand Voyager on the spot on your wrist where the gel was applied Do not fasten the strap y
4. 00 4 3 Radiated Electromagnetic Field Immunity Attention the ReliefBand Voyager produces physiological effects as described in this guide The ReliefBand Voyager is classified as TYPE B equipment California Only Perchlorate Material a as Special handling may apply See l m WWw dtsc ca gov hazardouswaste perchlorate e S AN ASIN This product contains natural rubber latex T which may cause allergic reactions IPX4 TECHNICAL DATA D ZE iaiia ies ai Teardrop shape 1 5 x 2 x 0 45 3 81 x 5 08 x 1 14 cm NY GUO IM sce ica cceratteensen dedocatatins Approximately 1 2 ounces 34 grams User Controls asccccccccscsctaxtceccnins Push Button User DiISPIAYS sccccccccsdcocosctemess On Flashing Green LED at Power Level Low Battery Flashing light indicator see figure 7 Output Channels 08 Two electrodes Maximum Output 35mA Battery streets ee nit iiias iiris Two 3V lithium coin cell batteries Not replaceable not rechargeable QUESTIONS AND ANSWERS When to use The ReliefBand Voyager e You can use your ReliefBand Voyager 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 the ReliefBand Voyager 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 e After the
5. 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 fingers when the ReliefBand Voyager is in the proper wrist location Stimulation will cycle every four seconds e f little or no tingling is felt after moving it around 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 curl your fingers slightly and bend your wrist up If the stimulation increases tighten the band at that point e 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 wear the ReliefBand Voyager e On the wrist that gives you the greatest tingling in the hand at the lowest stimulation level Is dry or sensitive skin a problem e For dry skin the gel may be lightly applied more often e 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 e The batteries should last up to 60 days based on approximate usage of device for 2 hours day of active use at power level 3 or below less time at higher power levels Battery life depends on individual usage of product How do know when the batteries are getting low e
6. et Slowly move the device around the gelled area until a tingling is felt in the palm of the hand and or into one or both of the two middle fingers see figure 5 This is your signal that you have found the right stimulation point The tingling will cycle every four seconds Figure 5 Activate the device No If you do not feel the tingling described above the ReliefBand Voyager may not be properly located over the nerve or the power level may be too low oo To increase the power level press the POWER button Each time you press the button the power level will increase one setting Adjust accordingly until you feel the highest comfortable level of stimulation Tingling in the thumb or side of the hand indicates that you are stimulating the wrong nerve Reposition the device to achieve the feeling in the palm and middle fingers If the device is set at level 5 and you press the POWER button once more the device will return to level 1 To turn off the device press and hold the power button for 3 seconds Relief Band gt y aygager Features and Components LOW BATTERY INDICATOR POWER BUTTON e Press to turn ON e Press again to increase to the next level e Press and hold for 3 to 5 seconds to turn OFF POWER SETTINGS 1 5 COMFORTABLE CLOTH BAND ADJUSTABLE Figure 7 Important You must feel stimulation in your palm and or middle fingers for the ReliefBand Voyager t
7. kelief A q Model RB DL I oyager INDICATIONS FOR USE The ReliefBand Voyager is indicated for use in the relief of nausea and vomiting due to motion sickness A IMPORTANT Positioning the ReliefBand Voyager properly on your wrist is essential for relief of your nausea and vomiting symptoms Before you start using the ReliefBand Voyager please read this Instructions for Use carefully You must feel stimulation in your palm and or middle fingers for the ReliefBand Voyager to work CONTENTS 1 ReliefBand Voyager Model RB DL I Preinstalled Batteries Not Replaceable 1 Hypo allergenic conductivity gel tube and Instructions for Use N E U R WAVE Manufactured for ee eee Neurowave Medical Technologies l 200 East Randolph Street 2009 Neurowave Medical Technologies Chicago IL 60601 USA In the U S A call 1 877 735 2263 9 00 AM 5 00 PM Mon Fri CST ReliefBand is a registered trademark 6006510 Rev B of Neurowave Medical 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 QNET BV aa No 2 449 554 Dye acy Designed in USA MFD in Malaysia 0086 The Netherlands The ReliefBand Voyager is a Class II medical device for the relief of nausea and vomiting due to motion sickness DESCRIPTION OF THE RELIEFBAND VOYAGER The ReliefBand Voyager is a transdermal neu
8. ld 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 ZN CAUTION e The ReliefBand Voyager is splash resistant This product is resistant to splashing water rain waves etc Do not immerse ReliefBand Voyager in water or wear while bathing The ReliefBand Voyager is also shock resistant e The elastic strap contains natural rubber latex which may cause allergic reactions ANN SIDE EFFECTS e 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 Voyager s or accessory
9. o RB DL I Neurowave Medical Technologies warrants each new ReliefBand Voyager 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 The ReliefBand Voyager is indicated for nonprescription over the counter use in relief of nausea and vomiting due to motion sickness The ReliefBand Voyager is not warranted to be effective in every case since relief varies dependent upon user characteristics Neurowave Medical Technologies s obligation under this Limited Warranty is expressly limited solely and exclusively to the replacement of the unit to which Neurowave Medical Technologies satisfaction is defective Contact Neurowave Medical 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 Voyager 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 limita
10. o work If you do not move the ReliefBand Voyager around the underside of the wrist area between the two tendons until stimulation is felt You will feel a tingling sensation in your palm and or middle fingers when the ReliefBand Voyager is in the proper wrist location Stimulation will cycle every four seconds If you still do not feel the stimulation be sure you have it set at an adequate power setting highest comfortable level and adjust position Adjusting Strap and Stimulation Level 1 Without moving the device from the stimulation point tighten strap until it fits snugly but comfortably It may be necessary to reposition the device after the strap is tightened see figure 6 Figure 6 No Adjust the power level for your optimum balance of stimulation and comfort Set the power level to the highest comfortable setting for maximum relief The stimulation will cycle every four seconds REMEMBER If you do not feel the tingling in the palm of your hand you will not be getting the relief the ReliefBand Voyager is capable of providing Adjust location and power setting to the highest comfortable level to get maximum relief How to turn off The ReliefBand Voyager To turn off the ReliefBand Voyager press and hold down the POWER button for at least 3 seconds Usage Tips 1 Try the ReliefBand Voyager on each wrist and use it on the wrist where the greatest tingling is felt at the lowest setting 2 Fo
11. r some people applying and rubbing in the gel twice assists in nerve stimulation 3 Gel should be re applied every 2 3 hours any time after washing or if stimulation decreases 4 While still on the wrist turn the ReliefBand Voyager off periodically to determine if you still have nausea and vomiting symptoms If you still have symptoms turn it back on immediately 5 When finished using the ReliefBand Voyager take it off your wrist and remove the gel from your wrist and the device with a tissue 6 When not using the ReliefBand Voyager be sure to turn the power off to extend battery life 7 Store the ReliefBand Voyager in a safe dry place Keep it away from young children
12. rostimulation medical device incorporated into a wristband worn on the underside of the wrist It provides relief from nausea and vomiting due to motion sickness by gentle electrical stimulation of the nerves in your wrist Batteries will last up to 60 days based on approximate usage of device for 2 hours day of active use at power level 3 or below The batteries of the ReliefBand Voyager are not replaceable SAFETY INFORMATION AN WARNINGS e 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 the ReliefBand Voyager when the cause of nausea and vomiting symptoms is undiagnosed because those symptoms might be an important indicator of more severe health problems The ReliefBand Voyager should only be used on the wrist Do not use it on any other areas of the body because the device might cause undesirable effects such as tingling muscle twitching or skin irritation The ReliefBand Voyager 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 differently The ReliefBand Voyager shou
13. tion may not apply to you This warranty shall not apply to any ReliefBand Voyager which has been repaired tampered with or altered by someone other than a duly authorized Neurowave Medical Technologies representative nor to any ReliefBand Voyager 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 Voyager Neurowave Medical 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 Voyager 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 CBIeIDan _ ayager How to use the ReliefBand Voyager 1 Find the Starting Location 1 On the underside of either wrist measure down two finger widths from the first crease below the hand see figure 1 Figure 1 Finding the starting location on your wrist for the device 2 Using your index finger locate the two tendons just under the skin in the center of the wrist With your finger find the area between the two tendons This is
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