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BEYOND PAIN Immediate benefit Simplicity Rapidity www.fremslife.com
Musculoskeletal pain is the effect and/or
the main cause of disability
is aimed at treating MUSCULOSKELETAL pain and reducing dysfunctions that
are often secondary to such painful conditions by offering an original, patented ultra-low
power Laser emission – now better known as PHOTOBIOMODULATION – to be applied
on sequences of points derived from acupuncture experience.
acts quickly on acute and chronic pain: a valuable aid for manual and
instrumental rehabilitation techniques.
Since musculoskeletal pain is one of the main causes of motor and balance dysfunctions,
treats musculoskeletal pain and related dysfunctions and can therefore play an
important role in functional recovery by reducing the Risk of accidental Falls.
The Intended Use
of Libralux is for the
following treatments
musculoskeletal pain and related dysfunctions;
relaxing or toning the musculoskeletal system*;
sores, ulcers and scar tissue
similar to Traditional Chinese Medicine (TCM)* Acupuncture
treatments. These treatments must be performed:
- in clinics that comply with the applicable regulations;
- by personnel who have the necessary skills and
qualifications (Doctor or Physiotherapist), duly trained
in the specific method.
(*) These treatments and those similar to Traditional Chinese Medicine Acupuncture treatments, which are described in the user
manual, can be performed under the operator’s responsibility and are not covered by the CE Certificate issued by the Notified Body
code 1936 for the Libralux product.
it is a medical device and it features:
Simplicity of application
Rapidity of execution
Immediate benefit for the patient
MODULAZIONE 1
+
By means of an
MODULAZIONE 2
extremely low frequency
+
laser beam extremely effective bio-stimulation
MODULAZIONE 3 is produced, thanks to a particular combination
= (patented) of wavelength, modulation and power.
MODULAZIONE The emission also includes low frequency
RISULTANTE
modulation against tissue habituation.
Simplicity Rapidity
The selections of protocols and, in sequence, all The Physical features of the beam (wave length,
the points to be stimulated with their anatomical modulation and power) are automatically adapted
picture are shown on the touch screen display: as specifically needed in order to stimulate each
point.
Immediate benefits
Musculoskeletal pain is
always associated with
an imbalance of the
physiological state.
This imbalance causes
a change in the state
of the Extracellular
• general rebalancing treatment, indicated also for matrix that alters the
preparatory purposes in a number of painful clin- interaction between
ical conditions*; the organs and tissues.
• treatment of ulcer, skin sores, scars; Thanks to its specific
• specific treatment for musculoskeletal pain in dif- patented photonic stimulation algorithm,
ferent body areas and for motor or balance disor- restores the correct “respiratory”
ders associated with them. cycle of the extracellular matrix proteins.
(*) T his treatment and those similar to Traditional Chinese Medicine Acupuncture treatments, which are described in the user manual, can be performed
under the operator’s responsibility and are not covered by the CE Certificate issued by the Notified Body code 1936 for the Libralux product.
Numerous clinical and laboratory re- Lorenzini L, Giuliani A, Giardino L, Calzà L. Baratto L, Capra R, Farinelli M, Monteforte P,
search projects confirm the effectiveness Laser acupuncture for acute inflammatory, Morasso P, Rovetta G. Sonographic exam-
of , also in treating disorders visceral and neuropathic pain relief: An ex- ination in patient with osteorathritis of the
secondary to pain itself: perimental study in the laboratory rat. Res cervical spine reveals soft-tissues chang-
Vet Sci. 2010 Feb;88(1):159-65. es due to apllication with very low-power
Giuliani A, Fernadez M, Farinelli M, Baratto L, Baratto L, Calzà L, Capra R, Gallamini M, modulated laser. Int J Clin Pharmacol Res.
Capra R, Rovetta G, Monteforte P, Giardino L, Giardino L, Giuliani A, Lorenzini L, Traverso S. 2000;20 (1-2):13-6
Calzà L. Very low level laser therapy attenu- Ultra-low-level laser therapy. Lasers Med Bergamaschi M, Ferrari G, Gallamini M,
ates edema and pain in experimental mod- Sci. 2011 Jan;26(1):103-12 Scoppa F. Laser acupuncture and auricu-
els. Int. J.Tissue React. 2004;26 (1-2):29-37 Petruzzelli S, Congiu A, Gallamini M, Pom- lotherapy in postural instability - a prelimi-
Giuliani A, Fernandez M, Giardino L, Calzà L, pei R. Ultra-low power laser stimulation nary report. J Acupunct Meridian
Farinelli M, Baratto L, Capra R. Peripher- impairs the adhesion of Staphylococcus Stud. 2011 Mar;4(1):69-74.
al Stimulation For Pain Treatment Pathos. aureus to primary human cells, and inter- Gallamini M. Treating balance disorders by
2003; 10 (4): 115-9 feres with the expression of staphylococcal ultra-low-level laser stimulation of acupoints.
Giuliani A, Lorenzini L, Gallamini M, Massel- pathogenic factors. New Microbiol. 2014 J Acupunct Meridian Stud. 2013 Apr;6(2):119-
la A, Giardino L, Calzà L. Low infra red laser Apr;37(2):193-9. 23.
light irradiation on cultured neural cells: ef- Giuliani A, Lorenzini L, Alessandri M, Torricel- Vanzini M, Gallamini M, Amblyopia: Can
fects on mitochondria and cell viability after la R, Baldassarro VA, Giardino L, Calzà L. In Laser Acupuncture Be an Option? Journal of
oxidative stress. BMC Complement Altern vitro exposure to very low-level laser modi- Acupuncture and Meridian Studies. (2016),
Med. 2009 Apr 15;9:8. fies expression level of extracellular matrix doi: 10.1016/j.jams.2016.01.017.
protein RNAs and mitochondria dynamics Evangelista L, De Meo B, Bernabei G, et al.
in mouse embryonic fibroblasts. BMC Com- Ultra-Low-Level Laser Therapy and Acu-
plement Altern Med. 2015 Mar 24;15:78. puncture Libralux: What Is so Special? Med-
Monteforte P, Baratto L, Molfetta L, Rovetta G. icines (Basel). 2019;6(1):40
Low-power Laser in osteoarthritis of the Vanzini M, Gallamini M. Laser Acupuncture
cervical spine. Int J Tissue React 2003;25(4): in Open-Angle Glaucoma Treatment: A Ret-
131-6 rospective Study of Eye Blood Flow. J Acu-
punct Meridian Stud. 2020;13(2):40-47
SPECIFICATIONS
Laser therapy device LIBRALUX
AC Main Power Supply MeanWell GSM18B05-P1J Output 5 Vdc, 15 W
Laser Class 2
Red light emission - Wavelength 655 nm
Peak power 7 mW
Mean Output power 0,0175 mW
Touchscreen Display 7’’
Certified according to EEC 93/42 Class IIa
Laser classified according to EN 60825 Class 2
Fremslife is certified ISO 13485 (standing Ed.)
LIBRALUX is CE Certified compliant to EEC 63/42 (Annex V)
www.imq.it
CERTIFICATO N.
CERTIFICATE N. 9124.BIOT
SI CERTIFICA CHE IL SISTEMA DI GESTIONE PER LA QUALITA’ DI
WE HEREBY CERTIFY THAT THE QUALITY MANAGEMENT SYSTEM OPERATED BY
FREMSLIFE SRL
VIA BUCCARI 9 - 16153 GENOVA (GE)
UNITA' OPERATIVE / OPERATIVE UNITS
VIA BUCCARI 9 - 16153 GENOVA (GE)
E' CONFORME ALLA NORMA / IS IN COMPLIANCE WITH THE STANDARD
ISO 13485:2016
PER LE SEGUENTI ATTIVITA' / FOR THE FOLLOWING ACTIVITIES
Progettazione, produzione, immissione in commercio e assistenza di elettrostimolatori neuromuscolari e
relativi elettrodi, apparecchi per diatermia e aghi monouso sterili per stimolazione elettrica percutanea
Design, production, placing on the market and servicing of neuromuscular electrical stimulators and related
electrodes, equipments for diathermy and sterile single use needles for percutaneous electrical stimulation
Ulteriori informazioni riguardanti l'applicabilità dei requisiti ISO13485:2016 possono essere ottenute consultando l'organizzazione
Further clarifications regarding the applicability of ISO 13485:2016 requirements may be obtained by consulting the organization
IL PRESENTE CERTIFICATO E' SOGGETTO AL RISPETTO DEL
REGOLAMENTO PER LA CERTIFICAZIONE DEI SISTEMI DI GESTIONE
THE USE AND THE VALIDITY OF THE CERTIFICATE SHALL SATISFY THE
REQUIREMENTS OF THE RULES FOR CERTIFICATION OF MANAGEMENT SYSTEMS
DATE: PRIMA CERTIFICAZIONE EMISSIONE CORRENTE SCADENZA
FIRST CERTIFICATION CURRENT ISSUE EXPIRY
2008-09-26 2020-07-24 2023-09-10
_________________________
IMQ S.p.A. - VIA QUINTILIANO, 43 - 20138 MILANO ITALY
Management Systems Division - Flavio Ornago
DEP LX_Eng_rev.01
SGQ N° 005 A
La validità del certificato è subordinata a sorveglianza annuale e riesame completo
Membro degli Accordi di Mutuo del Sistema di Gestione con periodicità triennale
Riconoscimento EA, IAF e ILAC The validity of the certificate is submitted to annual audit and a reassessment
Signatory of EA, IAF and ILAC of the entire management System within three years
Mutual Recognition Agreements
Fremslife s.r.l.
Via Buccari 9
16153 Genova
Tel: +39 010 6402911
Fax: +39 010 6402900
Email: info@fremslife.com
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