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Aneks k navodilom za uporabo medicinskega pripomočka Wellneo ELMAG Exclusive
Aneks, priložen k navodilom za uporabo, predstavlja povzetek sprememb na medicinskem pripomočku Wellneo ELMAG Exclusive.
Namenjen je uporabniku, da ga prebere in upošteva spremenjena navodila za uporabo.
1. Varnostna opozorila glede uporabe – prej najdeno na strani 23
Izdelek naj bo uporabljan v strožjem temperaturnem območju. Wellneo Elmag Exclusive 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 Exclusive je lahko skladiščen in
prevažan pri minimalni temperaturi 5°C.
2. Omejitve pri uporabi - prej najdeno na strani 26
- 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 Exclusive – na sebi ali na drugi osebi.
3. O bateriji – prej najdeno na strani 28
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 Exclusive
in baterije!
4. Čiščenje montažnih pasov in pripomočka – prej najdeno na strani 20
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!
5. Testiranje signala z uporabo testerja - prej najdeno na strani 19
Wellneo ELMAG Exclusive paket vsebuje tester, ki preverja delovanje pripomočka. Uporablja se ga na sledeč način:
a) Vključite pripomoček Wellneo Elmag Exclusive.
b) Izberite želeno frekvenco.
c) Tester primite z desno roko.
d) Pritisnite gumb na testerju in ga držite. Postavite tester na desno stran pripomočka Wellneo Elmag Exclusive.
e) Utripanje kontrolne lučke testerja pove, če pripomoček deluje. Hitrost utripanja ustreza izbranemu programu na pripomočku.
f) Tester pospravite.
g) Določili ste uporabnost izdelka. Če ne deluje, ga shranite za popravilo ali uveljavljanje garancijskih pravic.
6. Tabela indikacij s pripadajočimi programi (Wellneo ELMAG Exclusive) – prej najdeno na straneh 10, 11 in 12
PREDEL NAMESTITVE
INDIKACIJE
PROGRAMI
Področje glave
Migrenski glavobol
Medicinski pripomoček
namestite čim bliže na mesto
prizadetega dela. Na glavo si Nevralgija trigeminusa, pareza obraznega
živca (N. facialis), regeneracija živcev
ga lahko namestite s pomočjo
priloženih pasov ali s kapo.
4 ali 5 ali 6
6 ali 7
Bolečinski sindrom zaradi degenerativnih sprememb na hrbtenici in sklepih
Medicinski pripomoček
namestite neposredno na
mesto bolečine s pomočjo
priloženih pasov.
Bolečine v vratu, ramenih
6 ali 7
Bolečine v nadlahti
6 ali 7
Bolečine v komolcu
6 ali 7
Bolečine v kolku, kolenu in gležnju
6 ali 7
Bolečine v vratnem delu hrbtenice
6 ali 7
Bolečine prsnega dela hrbtenice
6 ali 7
Lumbago
4 ali 5
Bolečine v križu
4 ali 5
Išias
4 ali 5
Sindrom obrabe sklepnega hrustanca
(artroza)
8 ali 9
PREDEL NAMESTITVE
INDIKACIJE
PROGRAMI
Bolečinski sindrom zaradi vnetnih, revmatskih obolenj
Medicinski pripomoček
namestite neposredno na
mesto bolečine s pomočjo
priloženih pasov.
Bolečine v kolku, kolenu, gležnju
4 ali 5 ali 6
Revmatska vnetja sklepov in mišic
4 ali 5 ali 6
Revmatsko vnetje v hrbtenici
4 ali 5 ali 6
Artritis
4 ali 5
Bolečinski sindrom zaradi poškodb kosti, mišic in vezi/kosti
Medicinski pripomoček
namestite neposredno na
mesto zloma, zvina, poškodbe
s pomočjo priloženih pasov.
Zlomi in športne poškodbe
9
Zvini pri športu in drugih poškodbah
8
Prenapetost (entezopatija)
5 ali 6
Nateg (distenzija)
4 ali 5
Bolezenski sindrom srčno-žilnega sistema
Medicinski pripomoček
namestite na predel
pleksus solarisa s pomočjo
priloženega mošnjička.
Motnje krvnega pritiska
3 ali 0
PREDEL NAMESTITVE
INDIKACIJE
PROGRAMI
Sindrom psihosomatske preobremenitve
Medicinski pripomoček
namestite na predel
pleksus solarisa s pomočjo
priloženega mošnjička.
Nespečnost
3 ali 0
Sindrom športne preobremenitve
4 ali 5
Stres
1 ali 2 ali 3 ali 0
Stanje strahu in napetosti
1 ali 2 ali 3 ali 0
Psihosomatski sindrom
(Nevrovegetativna distonija)
8
Krepitev imunskega sistema
9
Motnje delovanja ledvic in reproduktivnega sistema
Medicinski pripomoček
namestite čim bližje sečilom
oziroma obolelemu mestu s
pomočjo priloženih pasov.
Vnetje prostate (prostatitis)
3 ali 0
Stresna inkontinenca
2 ali 3
Boleča menstruacija
5
Preležanine, golenične razjede, celjenje ran
Medicinski pripomoček
namestite neposredno
na mesto rane s pomočjo
priloženih pasov.
Preležanine, golenične razjede, celjenje
ran
4 ali 5 ali 6
Podatki o
proizvajalcu:
Unika – produkt d.o.o.
Dunajska cesta 238E
1000 Ljubljana
Slovenija, EU
Dodano: julij 2014
Annex to instructions for the use of medical device Wellneo ELMAG Exclusive
As addition to the previous version of instructions for the use of Wellneo ELMAG Exclusive, following changes were made to the product
and should be considered.
1. Safety precautions for the use - before found on page 59
The device should be operated in stricter temperature range: interval from -5°C to 45°C. Wellneo ELMAG Exclusive 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 62
- 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 64
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 Exclusive away from children!
4. Cleaning the straps and control unit of device - before found on page 56
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!
5. Testing signal with the usage of tester - before found on page 55
Wellneo ELMAG Exclusive package is equipped with tester that indicates if device is working as intended. Testing should be done by following
steps:
a) Turn on device Wellneo Elmag Exclusive.
b) Select program with desired frequency.
c) Hold the tester with right hand.
d) Press the button on the tester and hold it. Place the tester on the right side of device Wellneo Elmag Exclusive.
e) Flashing of indication light shows if device operates. The speed of blinking should match the selected program of device.
f) Store the tester.
g) You have determined the applicability of the product. If it is not working, save it for repair or warranty law enforcement.
6. Table of indications with programs of usage (Wellneo ELMAG Exclusive) – before found on page 46, 47 and 48
AREA OF APPLICATION
INDICATION
PROGRAM
Head
Medical device is placed
as close to affected area as
possible. It can be attached
using straps or a hat.
Migraine headache
4 or 5 or 6
Neuralgia trigeminusa, facial nerve
paralysis (N. faciors), nerve regeneration.
6 or 7
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
6 or 7
Pain in upper arm
6 or 7
Pain in the elbow
6 or 7
Pain in hip, knee and ankle
6 or 7
Pain in cervical spine
6 or 7
Pain in thoracic spine
6 or 7
Lumbago
4 or 5
Pain in lower back
4 or 5
Sciatica
4 or 5
Severe wear of articular cartilage
(arthrosis)
8 or 9
AREA OF APPLICATION
INDICATION
PROGRAM
Pain syndrome due inflammation, rheumatoid disease
Pain in hip, knee and ankle
Medical device is placed on
the area of pain directly using Rheumatoid inflammation of joints and
attached straps.
muscles
4 or 5 or 6
4 or 5 or 6
Rheumatoid inflammation in the spine
4 or 5 or 6
Arthritis
4 or 5
Pain syndrome because bone, muscle or connective tissue injury
Medical device is placed on
the area of fracture, sprain or
injury using attached straps.
Fractures and sports injuries
9
Sprains
8
Overextension (Enthesopathy)
5 or 6
Strain (Distension)
4 or 5
Cardio-vascular disease
Medical device is placed in
the area of plexus solaris
using attached pouch.
Blood pressure irregularities
3 or 0
AREA OF APPLICATION
INDICATION
PROGRAM
Psychosomatic syndrome due overload
Medical device is placed in
the area of plexus solaris
using attached pouch.
Insomnia
3 or 0
Overtraining syndrome
4 or 5
Stress
1 or 2 or 3 or 0
Fear and anxiety
1 or 2 or 3 or 0
Psychosomatic syndrome
(Neurovegetative distony)
8
Immune system support
9
Disorders of kidney disease and reproductive tract
Medical device is placed
as close as possible to
urinary tissues or source of
inflammation using attached
straps.
Inflamed prostate (prostatitis)
3 or 0
Stress incontinence
2 or 3
Menstrual pain
5
Bedsores, tibial ulcers, wound healing
Medical device is placed
directly on wound using
attached straps.
Bedsores, tibial ulcers, wound healing
4 or 5 or 6
The producer:
Unika – produkt d.o.o.
Dunajska cesta 238E
1000 Ljubljana
Slovenia, EU
Updated: July 2014