SaliPen User Manual
Contents
1. 5 Insert SaliPen flexible blue arms into your mouth under the tongue 6 Push SaliPen arms as back as possible and release them to allow contact with the gums 7 Relax your tongue and close your lips not your teeth over the SaliPen stem 8 Keep SaliPen in your mouth a few minutes see length of use below G SALIWELL 9 To take it out slightly press the flexible arms one to the other in order to detach the electrodes from the gums After that gently pull SaliPen out of your mouth Page 3 10 Press the ON OFF button once SaliPen light stops flashing indicating that the device is turned off 10 Wipe the stimulating arms with a wet towel 11 Place the SaliPen unit inside the daily carrying case Wearers of a removable denture may now wear it again Frequency and Length of Use You should adjust the number of times using the SaliPen in a day and the duration each time according to your condition and needs The following list provides some possible usage examples Intensive use 10 times a day for up to 10 minutes each time Moderate use e Five times a day for 1 minute each time e Twice a day for 5 minutes each time Light use twice a day for 1 2 minutes each time You may use SaliPen whenever you feel dryness in your mouth However it is recommended not to use it more than once every hour At initial use it is recommended to start using SaliPen ten 10 minutes each time If you are sa2. fresh batteries 2 Open the battery compartment by pressing with your nail or a coin as shown 3 Extract the used battery from its holder using your nail or a sharp pin It should pop up easily Extract from this side 6 4 Place the fresh battery inside the holder place the left side first and press it in 5 Return the cover of the battery compartment to its place 6 Test the device by pressing the ON OFF button If the LED flashes it is OK Safeguards e Do not use SaliPen in conjunction with other active medical therapy or testing such as short or microwave therapy EEG ECG etc e Do not use SaliPen if you wear an implanted electronic device like a deep brain stimulation device a cardiac pacemaker a cardiac defibrillator etc unless specialist medical opinion allowing the use has first been obtained G SALIWELL e Store SaliPen in its carrying case while not in use Page 5 e Do not expose SaliPen to heat or direct sunlight e Do not expose SaliPen to liquids other than water or saliva e Do not clean SaliPen using ultrasound ultrasonic devices e If SaliPen is dropped it may get fractures or cracks and hence damage to the electronic module e Don t use the equipment in the presence of flammable mixtures with air or with oxygen or nitrous oxide Frequently Asked Questions How does SaliPen work SaliPen sends electrical pulses of specific patterns that stimulate the nerves associated with sal
3. SaliPen THE HIGH TECH MOUTH MOISTENER User Guide Intended use Relief of oral dryness SaliPen is a device for short term applications of electro stimulation to increase salivary secretion Description stimulating unit SF 2 arms 2 pairs of electrodes SaliPen consists of two main modules a command unit and a stimulating unit The command unit the white part includes the electronic circuit with a jia battery compartment and stays always outside the mouth ON OFF button and The stimulating unit the blue part een includes a stem and two flexible arms battery compartment The stem is used to hold SaliPen between the lips The flexible arms carry the stimulating electrodes Both modules are connected together with a pin and can be separated by pulling away one from the other The package contains from left to right a case for daily carrying of SaliPen a SaliPen device Version 4 0 November 2015 G SALIWELL Basic usage Page 2 Wash your hands with soap and water before handling the device Wearers of a removable denture on the lower jaw should remove it before using SaliPen 1 Take SaliPen out from its case 2 Press the ON OFF button once SaliPen green light flashes indicating that the device is turned on If the light does not flash press the button again Open your mouth and lift up your tongue 4 Slightly press the flexible arms one to the other
4. ivary glands secretion The stimulated nerves excite both the salivary glands directly to secrete more natural saliva and stimulate the salivation control center of the brain to further command the salivary glands to secrete more saliva Can I feel the electrical pulses No The pulse intensity is below the human sensitivity level Can I sleep with SaliPen No How long does the power source of the intra oral device last SaliPen has been designed to operate for about 6 months However based on the frequency and intensity of use the power source may run out of power earlier If the SaliPen is out of power please replace the battery What if I break the SaliPen If the SaliPen is broken you should stop using it Can I use other dry mouth treatment methods in parallel with SaliPen This question should be addressed to your treating clinician How often should the SaliPen be replaced The command unit can be used indefinitely until it stops functioning or it breaks Like a toothbrush it is recommended to replace the stimulating unit about every 6 months or earlier or if it has physical damage G SALIWELL Where can I get a new stimulation unit Page 6 The stimulating unit can be purchased at Saliwell site www Saliwell com How effective is electro stimulation in relieving dry mouth A series of scientific clinical trials conducted by several independent groups in multiple leading medical centers have shown high effec
5. rference and 2 this device must accept any interference received including interference that may cause undesired operation Manufacturer contact details Saliwell Ltd 65 Hatamar St Harutzim 60917 Israel e mail service saliwell com EJLA _ European Representative Saliwell Ltd Gewerbepark Eschberger Weg Im Helmerswald 2 Gebaude 4 POB 102719 66121 Saarbr cken Germany Wwww Saliwell com oe SaliPen DRY MOUTH RELIEF LLU IIIN C E 7 290014 891005 40 C X e D AS il i 4 A E ces DRY LOT S N Date
6. tisfied with the results you can gradually decrease the length of use For some users one 1 minute of use induces satisfactory results for several hours others may need more intensive stimulation Many other variants are possible You may adjust the frequency and length of usage to your particular condition and convenience However use should be consistent even if only little effect is felt Clinical trials showed that it may take a few months of persistent use until reaching satisfactory results Care and Maintenance Ifthe device stops working please change the battery which is contained in the battery compartment see instructions below Clean SaliPen stimulating unit at least once a day with a soft bristle toothbrush G SALIWELL After each use clean the stimulating arms with wet towel Page 4 Ifrinsing is needed separate the stimulating arms from the control unit and rinse ONLY the stimulating arms Keep all other parts DRY Visually check the device before using it to make sure it is not broken or has cracks Do not use it if any internal part of the stimulating unit is exposed It is recommended to replace the stimulating unit about every 6 months or earlier or if it has physical damage Replacing the battery 1 If you notice that the green LED flashes weakly or does not flash at all this indicates that the battery should be replaced SaliPen uses coin cell battery type CR2032 3V Lithium Use only
7. tiveness of electro stimulation in increasing natural saliva secretion How fast can I feel the relief It is very individual some feel the relief immediately for others it takes a few days or weeks After I use SaliPen for a few minutes how long the effect lasts It is very individual for some the effect lasts a day for others an hour On average it lasts about 3 hours Will I feel continuous improvement over time Yes a clinical study shows a growing effectiveness upon using electro stimulation over time Typically it is improved up to 8 months and then stabilizes Specifications 13 cm 5 1 x 5 5 cm 2 2 3V bi phase pulses 5Hz OVDC 1mSec From 5 C to 40 C IP00 no protection G SALIWELL Legend amp Graphic Symbols Page 7 MANUFACTURER EUROPEAN REPRESENTATIVE DATE OF MANUFACTURING BATCH CODE CAUTION CONSULTING ACCOMPANYING DOCUMENTS CE CERTIFICATION AND SUPERVISING NOTIFIED BODY CODE CLASS Ila DEVICE FCC FEDERAL COMMUNICATIONS COMMISSION On Off TOGGLE SWITCH CONSULT INSTRUCTIONS FOR USE OPERATING TEMPERATURE LIMITATION SERIAL NUMBER DEGREE OF PROTECTION AGAINST ELECTRICAL SHOCK RECYCLE PROPERLY IN ACCORDANCE TO WEEE REGULATIONS KEEP DRY KEEP OUT OF SUNLIGHT G SALIWELL Page 8 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 inte
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