Information for Clinicians
Contents
1. GenNarino for dry mouth treatment It includes a description for case selection treatment and recommended maintenance procedures For more information about dry mouth see Increase in saliva secretion varies as a result of the patient s condition more specifically the residual capacity of the salivary glands The device s lifetime varies from one patient to another due to the selected stimulation intensity frequency of use and specific oral conditions Page 18 of 18 Saliwell GenNarino Clinician Information Appendix A About Dry Mouth You may also visit our website www saliwell com or send an email to service saliwell com ISO Standardization Saliwell GenNarino has been subjected to intensive biocompatibility tests according to the requirements of the ISO series of standards and has received ISO 13485 standardization and certification Saliwell s GenNarino system is an active device for non invasive short term applications According to Annex IX Rule No 5 and especially Rule No 9 of EC Directive 93 42 EEC the intra oral product is classified as a Medical Device Class Ia the external personal remote control unit is classified as Class I according to Rule No 12 Classification according to the EN IEC 60601 1 Internal Powered Electrical Medical Device BF type degree of protection against electrical shock IPX8 degree of protection against ingress of water of the intra oral device only C2. safety band surrounding the functional elements of the device electronic circuit electrodes and batteries Saliwell GenNarino Clinician Information Error No text of specified style in document Instructions for Use Advise your patient to use Saliwell GenNarino initially for ten minutes when he she feels that the mouth is dry Patients will learn to adjust the length of use which can be as short as one minute according to their needs Frequency of use also varies from patient to patient and typically ranges from twice to five times a day Nighttime use is possible However it is not recommended to use the device more than once every hour For more information see the User Guide Maintenance Saliwell GenNarino should be washed with water after every use and kept in its Saliwell case It is also recommended that the patient cleans the device once a day with soap For more information see the User Guide Recycling and discarding Both Saliwell GenNarino and personal remote control should be handled in the European Community countries in accordance to the Directive 2002 96 EC of the European Parliament and of the Council dated 27 January 2003 on Waste Electrical and Electronic Equipment WEEE At the end of each product life time it should be mailed back to SALTIWELL ISRAEL for proper recycling using the envelope provided in the purchasing package to Saliwell Ltd 2 Hatamar St Harutzim 60917 Israel Mai
3. 4 0197 MANUFACTURER CONTACT DETAILS Saliwell Ltd Saliwell Ltd Gewerbepark 2 Hatamar St Eschbergerweg Geb ude 4 Harutzim 60917 Israel 66121 Saarbr cken Phone 972 3 534 7592 Germany Fax 972 77 353 4338 E mail service saliwell com Page 5 of 18 Saliwell GenNarino Clinician Information Saliwell GenNarino System Saliwell GenNarino operation is based on the application of stimulating signals to the nerves associated with the salivary glands to enhance natural saliva secretion This is the most efficient method for relieving xerostomia Saliwell GenNarino is a noninvasive solution in which the stimulation electrodes are embedded inside a mouth guard like device see Figure 1 that can be inserted and removed from the mouth as necessary The stimulating electrodes protrude from the device However in order to prevent tissue injury a space is provided between the flange from which they protrude and the tissue Power source Electronic Circuit Stimulating Electrodes Figure 1 Mouth guard like option Enhancing saliva secretion not only relieves dryness but also provides essential dental caries fighting factors and other components that are critical for oral health Personal Remote Control The personal remote control assists patients in switching Saliwell GenNarino on and off before inserting the device in the mouth and or after it is removed When working with the personal remote control the front edge s
4. EASE THERAP AGENTS MIGRAINE MANAGEMENT MULTIPLE SCLEROSIS MANAGEMENT rrrrrrrrrrrrre Page 16 of 18 Saliwell GenNarino Clinician Information MUSCLE RELAXANTS NASAL DECONGESTANTS NASAL INHALANTS NAUSEA MEDICATIONS NERVE AGENT POISONING TREATMENT NUTRITIONAL SUPPLEMENTS OPHTHALMIC PREPARATIONS OPIOID ANTAGONISTS OSTEOPOROSIS MANAGEMENT PAGET S DISEASE MANAGEMENT PARKINSONISM DRUGS PSYCHOTROPIC AGENTS SEIZURE DISORDER MEDICATION SLEEP AIDS SMOKING CESSATION AIDS SYMPATHOMIMETIC COMBINATION TREATMENT OF ATTENTION TREATMENT OF GAUCHER DISEASE VASODILATORS Page 17 of 18 Saliwell GenNarino Clinician Information Appendix C Saliwell Guarantee Card SALIWELL Tip MEDICAL SYSTEMS Saliwell GenNarino Guarantee Card Serial number ssessesossseosesssssssseso 1 Saliwell Ltd guarantee is for a 12 month period from the day the GenNarino system has left our laboratory for any damage attributable to the fabrication 2 Saliwell Ltd guarantee is not valid in the following occasions 2 1 Misuse of the Saliwell GenNarino system 2 2 Maintenance which doesn t follow Saliwell instructions 2 3 Breakage of the device or the electrode 2 4 Damage which was caused by exposure to sun or heat 2 5 Damage which was caused by exposure to active liquids e g strong detergent hypochlorite acids etc 2 6 Damage which was caused by high power fall or neglect 2 7 Damage which was caused by the cl
5. Patient s chief complaint Dental history including xerostomia treatment Ifthe patient suffers from xerostomia etiology and severity of the condition Patients expectations from the treatment with Saliwell device Saliwell GenNarino Clinician Information Evaluation of the patient s compliance with the Saliwell treatment Oral Signs and symptoms related to Dry Mouth Patients suffering from dry mouth may complain about any of the following symptoms Decrease in the amount of the saliva Change in the texture of the saliva foamy viscous ropy Dry and or cracked lips Burning mouth Swelling and or pain of the salivary gland Frequent necessity of fluid intake when eating or when in bed Difficulty eating dry food using dentures swallowing speaking tasting food Bad breath or taste Waking up from sleep due to dry mouth Some patients express no complaint of xerostomia despite suffering from hyposalivation In these cases the signs of salivary gland hypofunction may help you diagnose the condition A patient suffering from the following conditions should be suspected of reduced salivation History of rampant or cervical caries Halitosis Bad taste sensation Fungal infection Burning mouth Xerostomia diagnosis Several symptoms are reliable indicators of xerostomia The following questionnaire may help you assessing your patient s condition Do you have the need to do something to keep you
6. Saliwell GenNarino Clinician Information Saliwell GenNarino Clinician Information SALIWELL Tlp MEDICAL SYSTEMS March 2007 Revision 21 Page 13 of 18 Saliwell GenNarino Clinician Information Copyright 2006 Saliwell Ltd All Rights Reserved No part of this document including the products and software described in it may be reproduced transmitted transcribed stored in a retrieval system or translated into any language in any form or by any means except documentation kept by the purchaser for backup purposes without the express written permission of Saliwell Ltd Gewerbepark Eschbergerweg Geb ude 4 66121 Saarbr cken Germany The only warranties for Saliwell Ltd products and services are set forth in the express warranty statements accompanying such products and services Nothing herein should be construed as constituting an additional warranty Product warranty or service will not be extended if the product is repaired modified or altered unless such repair modification of alteration is authorized in writing by Saliwell Ltd SALIWELL LTD PROVIDES THIS DOCUMENT AS IS WITHOUT WARRANTY OF ANY KIND EITHER EXPRESS OR IMPLIED INCLUDING BUT NOT LIMITED TO THE IMPLIED WARRANTIES OR CONDITIONS OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE THE INFORMATION POSTED HERE AND IN SALIWELL S WEBSITE WWW SALIWELL COM BY SALIWELL OR ANY THIRD PARTY SHOULD NOT BE CONSIDERED MEDICAL ADVICE AND IS NO
7. T INTENDED TO REPLACE CONSULTATION WITH A QUALIFIED PHYSICIAN YOU ARE ENCOURAGED TO CONFIRM THE INFORMATION CONTAINED HERE WITH OTHER SOURCES IN NO EVENT INCLUDING BUT NOT LIMITED TO NEGLIGENCE SHALL SALIWELL ITS DIRECTORS OFFICERS EMPLOYEES OR AGENTS BE LIABLE FOR ANY INDIRECT SPECIAL INCIDENTAL OR CONSEQUENTIAL DAMAGES INCLUDING DAMAGES FOR LOSS OF PROFITS LOSS OF BUSINESS LOSS OF USE OR DATA INTERRUPTION OF BUSINESS AND THE LIKE THAT RESULT FROM THE USE OF OR THE INABILITY TO USE THE INFORMATION IN THIS DOCUMENT EVEN IF SALIWELL OR A SALIWELL AUTHORIZED REPRESENTATIVE HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES Products and corporate names appearing in this document may or may not be registered trademarks or copyrights of their respective companies and are used only for identification or explanation and to the owners benefit without intent to infringe any rights Page 18 of 18 Saliwell GenNarino Clinician Information Contents OVEIVIEW sr Ee rt a a o ayaa a la aa a aa E Main Features and Benefits 4 ISO Standardization 5 Saliwell GenNarino System TETERE 6 Personal Remote Control 6 Saliwell GenNarino Treatment ________ gt 8 Treatment Indications 8 Medical Precautions 8 Adverse Effects 8 Procedures and Method of Use__ o S S S 9 Logistics 9 Taking the Impression 9 Materials 9 Technique 9 Disinfecting the Impre
8. d The disinfection process requires 10 minute soaking and air drying Receiving the Saliwell GenNarino kit Saliwell GenNarino is custom made to fit the patient s mouth Its fabrication takes up to 14 days not including standard shipment It is then shipped back to your office The device is valid for one year Unpacking Saliwell GenNarino kit includes Saliwell GenNarino turned off Carrying case The personal remote control User Manual for the patient Guarantee card see Appendix C Saliwell Guarantee Card Return envelope for the expired used device in European countries Summary sheet of clinician information Page 10 of 18 Saliwell GenNarino Clinician Information Setting Up and Delivering to the Patient User Manual Before delivering Saliwell GenNarino to the patient read the User Manual Setting Up Saliwell GenNarino is delivered switched off During the appointment with your patient activate it as follows Press the green button of the personal remote control to switch Saliwell GenNarino on pointing its front to the Saliwell GenNarino detector at a distance of 2 10 cm If the device is working properly the detector light blinks when it receives the command this operation should be done in a dimmed environment If during setup Saliwell GenNarino detector light does not respond to the personal remote control commands consult the Troubleshooting section in the User Manual For any furth
9. er questions or problems contact the Saliwell Help Desk by sending an email to service saliwell com Adjustment and Delivery to the Patient 1 2 Disinfect Saliwell GenNarino with a sterile sponge or gauze and 70 alcohol Insert Saliwell GenNarino into the patient s mouth by gently pushing it with your fingertips over the teeth First insert the side with the electrodes and then the other side If the patient reports discomfort make fine adjustments by releasing stressful spots inside the device Use a fit checker to locate the exact spot and a hand piece to remove a thin acrylic layer The electrodes length is adapted to the impression received by Saliwell without hurting the tissue If the patient feels that the electrodes prick the tisue you may slightly shorten the electrodes using the high speed turbine gently However overtrimming the electrodes will annul the stimulating effect as the electrodes must definitely be in contact with the tissue Thus minimal shortening of electrodes just to ensure they to not wound the tissue should be performed Patients after radioptherapy to the head and neck and receiving bisphosphonates are at increased risk of developing osteonecrosis of the jaws In those patients special attention is warranted in order to avoid injuring the tissue by the device especially the electrodes Caution To prevent damages to the electronic circuit inside Saliwell GenNarino avoid drilling in a 2 mm
10. es The Saliwell solution stimulates nerves associated with the salivary glands which are responsible for activating the glands and generating saliva The company s extensive research resulted in an innovative state of the art device targeted at stimulating salivary gland function by electrostimulating their associated nerves mainly the lingual nerve The system consists of an intra oral removable device named Saliwell GenNarino and a personal remote control Saliwell GenNarino is a noninvasive salivary gland electrostimulator embedded inside a mouth guard like appliance that can be inserted and removed at will This intelligent device contains a built in power source stimulation electrodes and a microprocessor that operates accurately and independently Moreover the device significantly reduces patient expenses for dry mouth therapeutic medication and prevents resulting complications for example rampant caries and oral mucosal diseases In a series of clinical trials conducted in several leading medical centers Saliwell GenNarino has proved to be highly efficient Main Features and Benefits Increases natural secretion of saliva Self contained unit with built in microprocessor and power sources Lasts up to one year before replacement Device is switched on and off by the personal remote control Induces no known side effects Suitable for most dry mouth patients This document is designed to acquaint the clinician with Saliwell
11. hould always be aimed towards Saliwell GenNarino remote control detector at a distance of no more than 10 cm and in a shadowed environment The personal remote control has two buttons one green and one black When one of the buttons is pressed Saliwell GenNarino detector blinks and the electrostimulation switches on or off The green button switches simulation ON The black button switches simulation OFF Page 6 of 18 Saliwell GenNarino Clinician Information Figure 2 Saliwell GenNarino personal Figure 3 Saliwell GenNarino remote control personal remote control battery compartment Page 7 of 18 Saliwell GenNarino Clinician Information Saliwell GenNarino Treatment Success of the treatment with Saliwell s products depends on the patient s condition needs and expectations Saliwell GenNarino operation is based on the electrostimulation of the nerves that control saliva secretion and therefore is effective in patients with insufficient salivation Treatment Indications Subjective feeling of dry mouth xerostomia Salivary gland hypofunction Appearance of secondary conditions to salivary gland hypofunction that can occur in the absence of xerostomia complaints e Rampant caries e Halitosis e Bad taste e Fungal infection e Burning mouth syndrome Patients with no measurable salivary glands secretion are susceptible to a reduced response to Saliwell GenNarino stimulation Medical Precautions The fo
12. ing your impression tray will be sent to you via registered airmail or courier according to your instructions Note All the forms can also be downloaded from our website Taking the Impression Impression of the lower dental arch is required for fabrication of Saliwell GenNarino Materials 1 Select a tray for the impression of the lower arch 2 Make sure the tray extends to the distal and lingual aspect of the 3 molar area at least 1 cm away in each direction 3 To ensure the stability of the impression use polyether or polyvinylsiloxane Technique 1 Use either the two stage impression technique heavy body first and then light body or the one stage impression technique 2 Apply adhesive on the impression trays based on the manufacturer s instructions 3 IMPORTANT Be sure to include in the impression no less than 3 mm tissue lingually to the lower third molars whether they are present or missing If your patient wears a lower removable prosthesis it is advisable to use Saliwell GenNarino without the prosthesis in the mouth in order to ensure intimate and stable contact of the electrodes with the tissue lingually to the lower third molar area Thus impression should be taken while the patients does not wear the prosthesis Saliwell GenNarino Clinician Information Figure 4 Impression Disinfecting the Impression Please soak the impression in a disinfecting solution before it is packed and delivere
13. inician s handpiece during adjustment of the device 3 A damaged device should be sent to our laboratories The repair of the Saliwell GenNarino requires a new impression of the patient FORM MN 01b Page 18 of 18
14. ling fees were reimbursed already by a deduction from the purchasing payment Saliwell GenNarino Clinician Information Appendix A About Dry Mouth Saliva facilitates the patient s speech taste chewing swallowing digestion and teeth protection Insufficient saliva production may lead to xerostomia which is the symptom of suffering from dry mouth Prevalence of Dry Mouth Xerostomia is a common symptom that may affect at least one tenth of the adult population Oral dryness is more common among the elderly and more common in women than in men For more information about dry mouth visit www saliwell com or www drymouth info Etiology of Dry Mouth Dry mouth is primarily caused by a compromised function of the salivary glands often induced by Medications Head and neck radiotherapy Autoimmune diseases for example Sjogren s Syndrome Anxiety states Diabetes HIV infection Other causes Comprehensive information about medications that can potentially induce dry mouth can be found in Appendix B Drugs Causing Dry Mouth and in www drymouth info Dry Mouth Diagnosis Saliwell GenNarino is indicated for the treatment of dry mouth The term dry mouth reflects two conditions that may or may not be related Xerostomia the individual s subjective sensation of dry mouth Hyposalivation reduced salivary flow rate Anamnesis It is recommended to record and document the following details
15. llowing medical conditions should be considered as a basis for special precautions prior to Saliwell GenNarino treatment Use of a pacemaker Pregnancy Psychiatric or psychological disorders Epileptic disorder Involuntary muscle movement disorder for example Parkinson s or Huntington s diseases It is recommended to consult a specialist in the specific area of the conditions listed above regarding concomitant use of Saliwell GenNarino Adverse Effects Prolonged use of Saliwell GenNarino may cause irritation due to the mechanical pressure of the electrodes on the mucosa Saliwell GenNarino Clinician Information Procedures and Method of Use Logistics The proceedings of delivering a Saliwell GenNarino to your patient are Contact Saliwell via website www saliwell com or e mail to sales saliwell com Saliwell sends to you a reply including a Quotation an Order Form and a Laboratory Instructions Form both to be completed by you Send to Saliwell a The completed Order Form via fax to 972 77 353 4338 b The impression and the completed Laboratory Instructions Form via mail or courier to Ortholine Dental Laboratory 16 Giborey Israel POB 8168 South Industrial Area Netanya 42504 Israel Important Protect properly the impression to avoid damage during transportation Your credit card will be charged after the receipt of the impression in Saliwell laboratory The Saliwell GenNarino kit includ
16. r mouth moist Do you get out of bed at night to drink water Do you have difficulties speaking due to lack of mouth lubrication Do you have difficulties swallowing dry food Hyposalivation diagnosis The diagnosis of hyposalivation is based on a simple in office saliva flow rate measurement The most common measurement method is Whole Saliva Collection in which saliva is collected in a tube for at least 5 minutes after having nothing in the mouth for at least 90 minutes The patient is asked to expectorate into the tube during the collection period and to refrain from swallowing saliva The tube is weighed prior and after saliva collection and the difference in weight measured in grams indicates the volume of saliva collected in Saliwell GenNarino Clinician Information milliliters This volume is finally divided by the number of minutes during which saliva has been collected to obtain to flow rate value To obtain stimulated salivary flow rate ask the patient to chew a piece of paraffin while collecting the saliva Due to circadian variations in flow rate repeated salivary collections should be performed at a similar time of the day The flow rate of saliva is a dynamic and variable parameter The following table provides an indication of normally found salivary flow rates Table 1 Whole salive flow rates Normal Flow Rate Abnormal Flow Rate Unstimulated whole saliva 0 3 0 4 ml min lt 0 1 ml min S
17. ssion 10 Receiving the Saliwell GenNarino kit 10 Unpacking 10 Setting Up and Delivering to the Patient 11 User Manual 11 Setting Up 11 Adjustment and Delivery to the Patient 11 Instructions for Use 12 Maintenance 12 Recycling and discarding 12 Appendix A About Dry Mouth___ Cd Prevalence of Dry Mouth 13 Etiology of Dry Mouth 13 Dry Mouth Diagnosis 13 Anamnesis 13 Oral Signs and symptoms related to Dry Mouth 14 Xerostomia diagnosis 14 Hyposalivation diagnosis 14 Appendix B Drugs Causing Dry Mouth _ gt gt gt S o 16 Appendix C Saliwell Guarantee Card _______ __ gt gt gt SS o 18 Page 18 of 18 Saliwell GenNarino Clinician Information Overview Thank you for choosing Saliwell GenNarino for the treatment of dry mouth Saliwell Ltd was established in 2003 with the aim of finding the most effective treatment for xerostomia The Saliwell solution is the result of almost 20 years of research by Saliwell founders followed by an extensive multinational research effort by leading academic and industrial groups from all over Europe Dry mouth is not a killer disease yet it can impair quality of life and oral health significantly not only by the constant discomfort of mouth dryness but also by inducing difficulties in swallowing chewing and speaking increased dental caries rate and bad breath The salivary glands can increase their secretion several folds from the basal level upon stimulation of their nerv
18. timulated whole Saliva 1 2 ml min lt 0 5 ml min Page 15 of 18 Saliwell GenNarino Clinician Information Appendix B Drugs Causing Dry Mouth Sensation of dry mouth may be caused by the intake of dryness inducing medications Of the most 50 prescribed medications in the US in 2003 64 were xerogenic Altogether there are 1 800 drugs in 80 drugs classes which are known to have the side effect of inducing dry mouth More information in www drymouth info The xerogenic drugs belong to the following and also other drug categories ABUSIVE DRUGS AIDS RELATEDTHERAPEUTIC AGENTS ALZHEIMER S DISEASE MANAGEMENT NALGESICS NAPHYLAXIS EMERGENCY KIT NOREXIANTS NTI ARRHYTHMIC MEDICATIONS NTI INFECTIVE AGENTS NTI INFLAMMATORY AGENTS NTI NEOPLASTIC AGENTS NTI RHEUMATIC AGENTS NTI ULCER AGENTS NTICHOLINERGICS amp ANTISPASMODICS NTIHISTAMINES NTIHISTAMINES AND DECONGESTANTS NTIHYPERLIPIDEMIC AGENTS NTIHYPERTENSIVES ASSISTED REPRODUCTIVE TECHNOLOGY BENZODIAZEPENE ANTAGONIST BLOOD MODIFIER BRONCHODILATORS CENTRAL NERVOUS SYSTEM STIMULANT CERVICAL DYSTONIA TREATMENT COLD AND COUGH PREPARATIONS DERMATOLOGICAL PREPARATIONS DIAGNOSTIC AIDS DIARRHEA MEDICATIONS DIGESTIVES DIURETICS ERECTILE DYSFUNCTION MANAGEMENT GASTROINTESTINAL AGENTS GENERAL ANESTHETICS HEMORRHEOLOGIC AGENT HORMONES HYPERPROLACTINEMIC DISORDERS HYPERTENSIVE EMERGENCY AGENT HYPOTENSION MANAGEMENT IMMUNOLOGIC AGENTS LOU GEHRING S DIS
Download Pdf Manuals
Related Search