Aneks k navodilom za uporabo medicinskega pripomočka Wellneo ELMAG Pain relief

Transcription

1 Aneks k navodilom za uporabo medicinskega pripomočka Wellneo ELMAG Pain relief Aneks, priložen k navodilom za uporabo, predstavlja povzetek sprememb na medicinskem pripomočku Wellneo ELMAG Pain relief. Namenjen je uporabniku, da ga prebere in upošteva spremenjena navodila za uporabo. 1. Varnostna opozorila glede uporabe prej najdeno na strani 21 Izdelek naj bo uporabljan v strožjem temperaturnem območju. Wellneo Elmag Pain relief namestite tako, da ni neposredno v stiku s kožo. Če je izdelek v uporabi, mora biti uporabljan v temperaturnem območju okolice od -5 C do 45 C. Wellneo Elmag Pain relief je lahko skladiščen in prevažan pri minimalni temperaturi 5 C. 2. Omejitve pri uporabi - prej najdeno na strani 24 - Otroci mlajši od 7 let ne smejo uporabljati izdelka. - Uporabnik mora imeti sposobnost bralnega razumevanja vsaj 4 leta. - Uporabnik mora nujno prebrati navodila za uporabo skupaj z aneksom, preden prične z uporabo izdelka Wellneo Elmag Pain relief na sebi ali na drugi osebi. 3. O bateriji prej najdeno na strani 26 Baterija mora biti zamenjana z enako CR2032 3V baterijo in ne sme biti izpostavljena temperaturi nad 45 C ter močnim sevanjem z radiofrekvencami (mikrovalovna pečica, itd.). Predpisani protokol zamenjave baterije: a) Demontirajte zaščitni pokrov baterije. b) Previdno izvlecite ven staro baterijo. c) Preverite polariteto nove baterije. d) Preverite polariteto ležišča baterije. e) Vstavite novo baterijo v ležišče tako, da se polariteti ujemata. f) Montirajte zaščitni pokrov baterije nazaj. Če nekdo pogoltne baterijo, nujno poiščite urgentno medicinsko pomoč. Preprečite otrokom dosegljivost pripomočka Wellneo ELMAG Pain relief in baterije!

2 4. Čiščenje montažnih pasov in pripomočka prej najdeno na strani 18 Montažni pasovi se lahko perejo v pralnem stroju pri nizkih temperaturah (30 C - 40 C) ob uporabi nežnih detergentov. Izdelek sam ni neposredno podvržen higienskim nevarnostim. Z obzirom na občutljivost elektronike se ga lahko čisti s suhim brisanjem, pri čemer se uporablja neabrazivno krpo (bombaž, mikrovlakna). Če pri čiščenju uporabljate kemične aditive, najprej izdelku odstranite baterijo. Predlagana je z vodo navlažena krpa ali sredstva za čiščenje hišne elektronike kot je računalniški zaslon, prenosni računalnik in pametni telefon. Ne sme se uporabljati čistil, ki vsebujejo parfume ali naftne derivate!

3 5. Tabela indikacij s pripadajočimi programi (Wellneo ELMAG Pain relief) prej najdeno na straneh 10 in 11 PREDEL NAMESTITVE INDIKACIJE PROGRAMI Bolečinski sindrom zaradi degenerativnih sprememb na hrbtenici in sklepih Medicinski pripomoček namestite neposredno na mesto bolečine s pomočjo priloženih pasov. Bolečine v vratu, ramenih 5 ali 6 Bolečine v nadlahti 5 ali 6 Bolečine v komolcu 5 ali 6 Bolečine v kolku, kolenu in gležnju 5 ali 6 Bolečine v vratnem delu hrbtenice 5 ali 6 Bolečine prsnega dela hrbtenice 5 ali 6 Lumbago 3 ali 4 Bolečine v križu 3 ali 4 Išias 3 ali 4 Področje glave Medicinski pripomoček namestite čim bliže na mesto prizadetega dela. Na glavo si ga lahko namestite s pomočjo priloženih pasov ali s kapo. Migrenski glavobol 3 ali 4 ali 5

4 PREDEL NAMESTITVE INDIKACIJE PROGRAMI Bolečinski sindrom zaradi vnetnih, revmatskih obolenj Medicinski pripomoček namestite na predel pleksus solarisa s pomočjo priloženega mošnjička. Bolečine v kolku, kolenu, gležnju 3 ali 4 Revmatska vnetja sklepov in mišic 3 ali 4 Revmatsko vnetje v hrbtenici 3 ali 4 Artritis 3 ali 4 Motnje delovanja ledvic in reproduktivnega sistema Medicinski pripomoček namestite čim bližje sečilom oziroma obolelemu mestu s pomočjo priloženih pasov. Vnetje prostate (prostatitis) 1 ali 2 Boleča menstruacija 4 Podatki o proizvajalcu: Unika produkt d.o.o. Dunajska cesta 238E 1000 Ljubljana Slovenija, EU Dodano: julij 2014

5 Annex to instructions for the use of medical device Wellneo ELMAG Pain relief As addition to the previous version of instructions for the use of Wellneo ELMAG Pain relief, following changes were made to the product and should be considered. 1. Safety precautions for the use - before found on page 53 The device should be operated in stricter temperature range: interval from -5 C to 45 C. Wellneo ELMAG Pain relief should not be used in direct contact with the body. If stored and transported, minimal temperature exposed should be minimum 5 C. 2. Restrictions on use - before found on page 56 - The device should not be used for people under 7 years old. - The device should be used for people with 4+ years intensive reading comprehension experience. - User must read instructions for the use and annex before using the product on himself or anybody else. 3. Battery - before found on page 58 Battery should be replaced with the same CR2032 3V battery only and has to be used below 45 C. It must not be exposed to strong radio-wave radiation (microwave oven, etc.)! Replacing of battery is done with following steps: a) Removing protective cover of battery. b) Pull out an old battery. c) Check the polarity of new battery. d) Check the polarity of connector. e) Insert a new battery in the socket so that polarities match. f) Assemble the battery cover back. If battery is ingested by accident, urgent medical help is needed. Keep the battery and the product Wellneo ELMAG Pain relief away from children!

6 4. Cleaning the straps and control unit of device - before found on page 50 All straps can be cleaned in a washing machine at low temperatures (30-40 C) using mild detergents. Control unit of device is not subject to hygiene hazards and has more delicate protocol while cleaning. Dry cleaning is suggested to avoid any risk for damaging the electronic components. Plain, clean, dry, lint-free cloth is suggested as well as use of microfiber cloths. If chemical additive is used to rub the housing, the battery should be removed first. Suggested agent for semi-wet cleaning are water wet cloth, or additives used for house electronics usually intended for computer screens, laptops, and smartphones. Do not use cleaners that contain perfumes or other petrochemicals!

7 5. Table of indications with programs of usage (Wellneo ELMAG Pain relief) before found on pages 42 and 43 AREA OF APPLICATION INDICATION PROGRAM Pain syndrome due degenerative changes in the spine and joints Medical device is placed on the area of pain directly using attached straps. Pain in neck, shoulders 5 or 6 Pain in upper arm 5 or 6 Pain in the elbow 5 or 6 Pain in hip, knee and ankle 5 or 6 Pain in cervical spine 5 or 6 Pain in thoracic spine 5 or 6 Lumbago 3 or 4 Pain in lower back 3 or 4 Sciatica 3 or 4 Head Medical device is placed as close to affected area as possible. It can be attached using straps or a hat. Migraine headache 3 or 4 or 5

8 AREA OF APPLICATION INDICATION PROGRAM Pain syndrome due inflammation of rheumatoid syndrome Medical device is placed directly on plexus solaris using attached straps. Pain in hip, knee and ankle 3 or 4 Rheumatoid inflammation of joints and muscles 3 or 4 Rheumatoid inflammation in the spine 3 or 4 Arthritis 3 or 4 Disorders of kidney disease and reproductive tract Medical device is placed on the area of fracture, sprain or injury using attached straps. Inflamed prostate (prostatitis) 1 or 2 Menstrual pain 4 The producer: Unika produkt d.o.o. Dunajska cesta 238E 1000 Ljubljana Slovenia, EU Updated: July 2014