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User and maintenance manual
Sheet 1 of 24
Date
18/ 02/ 2013
Rev. 01
Focusmed S.r.l. – Largo Traiano n.4 – Montegrotto Terme (PD) VAT number 04590310282
High-frequency and low-intensity device for dermatological and skin wound treatment, wound care and biostimulation
RINOVACELL® Patent application PD 2011A000385
MANUAL
Instructions for maintenance and use
RINOVACELL®
User and maintenance manual
Sheet 2 of 24
Date
18/ 02/ 2013
Rev. 01
Focusmed S.r.l. – Largo Traiano n.4 – Montegrotto Terme (PD) VAT number 04590310282
High-frequency and low-intensity device for dermatological and skin wound treatment, wound care and biostimulation
RINOVACELL® Patent application PD 2011A000385
Foreword............................................................................................................................................................... 3
Safety information............................................................................................................................................... 3
General information............................................................................................................................................. 7
Technical data...................................................................................................................................................... 7
Reference standards............................................................................................................................................ 9
Instructions for use............................................................................................................................................. 9
a) Area of use................................................................................................................................................... 9
b) Pre and post treatment indications............................................................................................................... 9
c) Switching on, controls and information..................................................................................................... 10
d) Description of the screen prompted by the touch screen........................................................................... 12
e) Choice of handpiece................................................................................................................................... 12
f) Treatment parameters................................................................................................................................. 13
g) Dermatological and skin wound treatment, wound care........................................................................... 14
h) Contraindications....................................................................................................................................... 14
i) Protection measures.................................................................................................................................... 14
l) Use.............................................................................................................................................................. 15
m) Precautions for use................................................................................................................................... 17
Maintenance....................................................................................................................................................... 18
a) General information................................................................................................................................... 18
b) Annual check............................................................................................................................................. 18
c) Sterilisation of the handpieces and relative screw-on plates and discs..................................................... 18
d) Daily check................................................................................................................................................ 19
e) Handpieces and mat................................................................................................................................... 19
Warranty............................................................................................................................................................. 20
Disposal............................................................................................................................................................... 20
Annex 1: EMC tables…………………………………………………………………………………..……… 20
Immunity aspects.…………………………………………………………………………………………... 21-23
User and maintenance manual
Sheet 3 of 24
Date
18/ 02/ 2013
Rev. 01
Focusmed S.r.l. – Largo Traiano n.4 – Montegrotto Terme (PD) VAT number 04590310282
High-frequency and low-intensity device for dermatological and skin wound treatment, wound care and biostimulation
RINOVACELL® Patent application PD 2011A000385
Foreword
This document provides information on the preparation and correct use of the
RINOVACELL® device.
It is an essential reference guide for the user: before installing and using the
machine, read the contents of this manual carefully and always keep it handy
for rapid consultation.
Failure to comply with the recommendations provided here could cause malfunctioning or
damage of the device and invalidate the warranty.
Safety information
To avoid risks of fire or electric shock, do not expose the device to driving rain or relative
humidity exceeding 75% with condensation.
Ensure there are no extreme conditions and, if there are, do not open the case and do not
switch on the device.
WARNING: to reduce the risks of fire or electric shock, do not remove the device panel.
Contact only qualified technical personnel in the case of problems.
The symbol showing a lightning bolt inside an equilateral triangle warns the user
of the presence of dangerous voltages inside the device and the risk of electric shock.
ELECTRIC SHOCK HAZARD These words warn users about the meaning of said symbol.
This symbol warns users of the existence of important safety information in
the manual.
This symbol warns users that the device emits radio-frequency signals but not
ionising radiation
User and maintenance manual
Sheet 4 of 24
Date
18/ 02/ 2013
Rev. 01
Focusmed S.r.l. – Largo Traiano n.4 – Montegrotto Terme (PD) VAT number 04590310282
High-frequency and low-intensity device for dermatological and skin wound treatment, wound care and biostimulation
RINOVACELL® Patent application PD 2011A000385
This symbol identifies the LF parts applied.
I n addition to norm al safety precautions, please note the follow ing
points to protect your ow n safety, patient's safety and the safety of the product
and its accessory parts.
This symbol indicates that the user must keep the device in a dry place away
from water.
•
•
•
•
•
•
•
•
•
•
•
•
•
Do not overload the wall socket by connecting double or triple plugs, or multiple
plugs, as this device must be plugged in on its own in a single wall socket.
It is dangerous to use unprotected sockets.
Check the electrical connections are correct and that there are no uncovered
cables and, if there are, contact qualified technical personnel.
Ensure the socket is properly earthed and that it complies with current earthing
quality standards.
Do not use current sockets near water containers, swimming-pools, bathtubs,
showers, washing machines, sinks, etc.
Do not place the device on unstable surfaces, as this could cause serious
damage to people and to the device itself.
Never place the device close to heaters, radiators, ovens, fans, audio and/or
television and/or video amplifiers and/or CD/DVD players and/or cordless
telephones, as this could cause its malfunctioning and/or interference.
Always unplug the device before cleaning it.
Do not attempt to insert the plug in old-fashioned type sockets, do not force the
plug into the socket, if necessary call a qualified electrician.
Avoid standing on the power cable or placing objects on top of it and, if it is
damaged, replace it with an equivalent new one.
Unplug the device in the case of electrical storms or lengthy absence.
Do not attempt to open the device and do not touch the components inside it,
as these operations must be performed solely by qualified and authorised
maintenance/repair personnel.
Do not tamper with RINOVACELL®, as opening and/or tampering with
RINOVACELL® by unauthorised personnel invalidates the warranty and the
device cannot be placed in service.
User and maintenance manual
Sheet 5 of 24
Date
18/ 02/ 2013
Rev. 01
Focusmed S.r.l. – Largo Traiano n.4 – Montegrotto Terme (PD) VAT number 04590310282
High-frequency and low-intensity device for dermatological and skin wound treatment, wound care and biostimulation
RINOVACELL® Patent application PD 2011A000385
•
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Install the device where there is good air circulation and do not block the
ventilation on the device itself.
Do not place beakers, bottles, creams, gels, various product containers, etc., on
the cover inside the device under any circumstances.
Do not pull the cables.
Do not press the touch screen too hard.
If RINOVACELL® signals a malfunction or does not emit energy, switch it off
immediately, unplug it and call technical assistance.
W arning: RINOVACELL® emits electromagnetic fields through the handpiece, which,
when applied to the patient, are closed through the isolating mat, which MUST be
connected to the jack socket of RINOVACELL® and positioned under the patient (contact
with the skin and use of conducting creams or gels is unnecessary).
RINOVACELL® may cause interference with other devices, do not use RI NOVACELL ® in
a surgical environm ent or close to Critical Care equipm ent. If the device interferes
with household appliances such as televisions, radios, CD/DVD players, cordless
telephones, etc., it is normally sufficient to stop treatment momentarily and leave or
change the room or possibly switch off the appliance in question before starting the
treatment again,
Also comply at all times with the indications clearly visible on the device, on the label
applied inside the cover and described below.
FOCUSMED S.r.l.
Largo Traiano, 4
Montegrotto Terme (PD)
Tel. 389.0666696
A professional operator authorised to use the device at the patient's own home must first
check that the electrical wiring complies with legal standards and is periodically checked
by qualified personnel.
If these conditions are not complied with, DO NOT perform the treatment.
User and maintenance manual
Sheet 6 of 24
Date
18/ 02/ 2013
Rev. 01
Focusmed S.r.l. – Largo Traiano n.4 – Montegrotto Terme (PD) VAT number 04590310282
High-frequency and low-intensity device for dermatological and skin wound treatment, wound care and biostimulation
RINOVACELL® Patent application PD 2011A000385
RINOVACELL® is designed for use by doctors and specific healthcare
professionals (e.g. professional nurses), who use it under medical prescription
in a suitable environment, such as a doctor's surgery/outpatient clinic and/or
hospital. It may be used at home by designated doctors and healthcare
operators, with all the necessary precautions. The device and the discs are
self-sterilisable.
RINOVACELL® may not be used autonomously by patients. Keep away from
children and always lock with the keys provided.
I n the case of problem s, sw itch off and unplug the device and im m ediately
contact the assistance service.
User and maintenance manual
Sheet 7 of 24
Date
18/ 02/ 2013
Rev. 01
Focusmed S.r.l. – Largo Traiano n.4 – Montegrotto Terme (PD) VAT number 04590310282
High-frequency and low-intensity device for dermatological and skin wound treatment, wound care and biostimulation
RINOVACELL® Patent application PD 2011A000385
General information
RINOVACELL® is a new device which, through use of high-frequency and low-intensity currents,
stimulates skin and subcutaneous tissues through two types of handpiece, with the choice of
three types of high frequency:
• 2 Mhz LF;
• 4 Mhz MF;
• 8 Mhz HF.
It is possible to adjust the power, choose the cycles and the cycle times and adjust the volume
of the sound emitted.
Key: 1 Joule, the symbol “J” expresses the unit of measurement of the energy and coincides
with Watt per second J = W*s = N*m = K *m / s2.
Technical data
Parameters
Values
BRAND NAME OF THE PRODUCT
RINOVACELL
FUNCTION AND PURPOSE OF USE
High-frequency treatment of difficult
wounds, such as bedsores, ulcers,
diabetic feet, skin wounds/lesions in
general, oedemas, dermatological
and skin wound treatment, wound
care and biostimulation.
WEIGHT
<10.5 Kg
ELECTRIC POWER
Single-phase 110 - 220 V ±
10% - 50/60 Hz, through a plug with
protection cable and no voltage
change.
IEC connectorised cable, separable
with socket/plug.
User and maintenance manual
Sheet 8 of 24
Date
18/ 02/ 2013
Rev. 01
Focusmed S.r.l. – Largo Traiano n.4 – Montegrotto Terme (PD) VAT number 04590310282
High-frequency and low-intensity device for dermatological and skin wound treatment, wound care and biostimulation
RINOVACELL® Patent application PD 2011A000385
ABSORBED POWER
250 VA (max)
POWER SUPPLIED
70 Watt (max)
FREQUENCIES
LF = 2 MHz
MF= 4 MHz
HF= 8 MHz
0°C∙35°C
10%-80%
500∙1060hPa
Ambient temperature: -10 ÷ +50 °C;
Relative humidity: 10 ÷ 90 %,
condensation included;
Atmospheric pressure: 500 ÷ 1060
hPa
ENVIRONMENTAL OPERATING CONDITIONS
STORAGE AND TRANSPORT
NUMBER of handpieces
No. 2
EMISSION METHOD
Continuous 70 Joule maximum on 100
Ohm
Reflected power control 10.5 Joule
max
Maximum effective INTENSITY in normal use
and in first fault conditions
8.5
5.6
3.5
2.5
Single emission cycle TIME:
Maximum number of cycles:
1 / 30 min.
20 cycles
J
J
J
J
cm2
cm2
cm2
cm2
on
on
on
on
30
40
50
60
mm
mm
mm
mm
handpiece
handpiece
handpiece
handpiece
SAFETY CLASS
INTERNAL ELECTRICAL SOURCE:
(IEC EN 60601-1,
IEC EN 60601-2-3).
I LF type
+ 48V, 4 A and +24 V 3 amp
FUSE VALUES:
2.5 Amps
DEGREE OF PROTECTION ASSOCIATED WITH
THE DEVICE
IP20
User and maintenance manual
Sheet 9 of 24
Date
18/ 02/ 2013
Rev. 01
Focusmed S.r.l. – Largo Traiano n.4 – Montegrotto Terme (PD) VAT number 04590310282
High-frequency and low-intensity device for dermatological and skin wound treatment, wound care and biostimulation
RINOVACELL® Patent application PD 2011A000385
Reference standards
Active treatment device, class I and LF type , class IIb according to EEC 93/42 and EC
07/47, as it releases energy to the human body in a potentially non-hazardous form,
taking into account the nature, density and part to which the energy is applied (Rule 09
annex 09 directive 93/42/EC).
Instructions for use
a) Area of use
RINOVACELL® may be used in any environment satisfying electrical wiring standards and
the authorisations required by current legislation.
The device is also designed for home use.
If the device interferes with household appliances, such as televisions, radios, CD/DVD
players, cordless telephones, etc., stop treatment momentarily and leave or change the
room or possibly switch off the appliance in question before starting the treatment again.
Do not use other electro-medical devices on the patient while using RINOVACELL®, to
avoid any interference between them and/or complications.
Do not use RINOVACELL® in a surgical environment or close to Critical Care
equipment: it could create interference.
b) Pre and post treatm ent indications
It is not necessary to follow a specific protocol or take particular precautions before
treatment.
The handpiece/disc used must obviously be properly disinfected and all necessary tests
performed on the patient.
Patients can usually return to normal activities after treatment, but healthcare staff
performing the treatment and caring for the patient will provide indications on this.
No post-treatment precautions are necessary.
However, healthcare staff performing the treatment and caring for the patient will provide
indications on this.
User and maintenance manual
Sheet 10 of 24
Date
18/ 02/ 2013
Rev. 01
Focusmed S.r.l. – Largo Traiano n.4 – Montegrotto Terme (PD) VAT number 04590310282
High-frequency and low-intensity device for dermatological and skin wound treatment, wound care and biostimulation
RINOVACELL® Patent application PD 2011A000385
c) Sw itching on, controls and inform ation
RINOVACELL® is equipped with the following accessories (FIGURE 1):
- No. 1 handpiece with application head (plate/disc), diameter 60 mm
- No. 1 handpiece with application head (plate/disc), diameter 30 mm
- No. 1 power cable with 10 Amp plug and earthing
- No. 1 cable with two banana terminals for connection between the case and the
insulating mat to close return currents
- No. 1 insulating mat which closes high-frequency return currents.
FIGURE 1
User and maintenance manual
Sheet 11 of 24
Date
18/ 02/ 2013
Rev. 01
Focusmed S.r.l. – Largo Traiano n.4 – Montegrotto Terme (PD) VAT number 04590310282
High-frequency and low-intensity device for dermatological and skin wound treatment, wound care and biostimulation
RINOVACELL® Patent application PD 2011A000385
Attach the above accessories to the high-frequency generator contained in the bottom
part of the case.
The power switch is on the socket in the top right-hand corner;
- Connect the power cable to the generator socket (lower part of the case);
- Ensure the ON/OFF switch is in the OFF position;
- Connect the 10 amp plug to the wall socket;
- Place the device close to the chair or bed where the patient is sitting or lying;
- Place the insulating mat on the chair and connect it with the special cable with
banana terminals on the generator surface;
- Connect the respective movable connector on the handpiece chosen to the
generator connector and tighten carefully;
- At this point, switch on RINOVACELL® and check that the green ON Led near the
inlet socket switches on.
FIGURE 2
User and maintenance manual
Sheet 12 of 24
Date
18/ 02/ 2013
Rev. 01
Focusmed S.r.l. – Largo Traiano n.4 – Montegrotto Terme (PD) VAT number 04590310282
High-frequency and low-intensity device for dermatological and skin wound treatment, wound care and biostimulation
RINOVACELL® Patent application PD 2011A000385
- Check that the display shows the figure below (fig. 3)
d) Description of the screen prom pted by the touch screen
RINOVACELL® shows only one screen, which allows the operator to select the machine
functioning and emission methods.
This is a touch screen with graphic representations of buttons for:
- Choosing the operating frequency (LF, MF, HF);
- Choosing the emission power (expressed in W, corresponding with 1 second at 1 Joule
per cm2); power is expressed in a percentage of the maximum possible power.
- Choosing the unit emission cycle time;
- Choosing the number of repetitions of the emission cycle desired
FIGURE 3
e) Choice of handpiece
As already described, there are two RINOVACELL® handpieces, with the sole difference
being the dimensions of the application plates/discs (60 mm and 30 mm in diameter).
Please note that, with the same emitted power, this will be distributed on the two
User and maintenance manual
Sheet 13 of 24
Date
18/ 02/ 2013
Rev. 01
Focusmed S.r.l. – Largo Traiano n.4 – Montegrotto Terme (PD) VAT number 04590310282
High-frequency and low-intensity device for dermatological and skin wound treatment, wound care and biostimulation
RINOVACELL® Patent application PD 2011A000385
surfaces and, in the case of the 30 mm plate, the application power will be slightly less
than double the power emitted by the 60 mm diameter plate.
The two treatment plates/discs are screwed onto the handpiece and it is recommended
to return them to the foam rubber housing in the cover as soon as possible, to avoid
dropping them and losing the insulation necessary for correct use.
The white colour of the external vitrification treatment allows an easy inspection of the
state of the surface.
If there are scratches or the colour is no longer pure white, request a replacement of the
application plate.
In the case of wear and tear, damage and/or scratches on the transmission plate of the
handpiece, replace immediately, to ensure the patient's safety.
The operator decides whether to slide the handpiece chosen on the patient's
skin or hold it still, depending on requirements.
The choice of handpiece basically depends on the size of the area to be treated, the
energy to be supplied (power) and the patient's pathology.
f) Treatm ent param eters
One of the basic guidelines in choosing treatment parameters is what the patient feels.
In order to optimise treatment, it is particularly important for the patient to feel a
pleasant warmth (NOT BURNING) during the single treatment cycle.
The maximum feeling of heat must NEVER reach the pain threshold. It is equally
important to consider that sensitivity to heat and/or pain differs greatly from patient to
patient. Therefore, with the same treatment parameters, different patients could report
significantly different sensations.
WARNING! The patient could be “burned” if too much energy is supplied; it is
recommended to start treatment at 40% of power, carefully observing what the patient
perceives.
An average treatment should last 15 minutes and 50 minutes of treatment per
session should be the maximum. The duration of the treatment depends on the size
of the area to be treated and the choices made by the doctor or the healthcare operator,
according to the patient concerned and the pathology involved.
One session every seventy-two hours is recommended.
However, the doctor and/or nurse using the device decides the treatment method and
therefore the frequencies and handpieces, times, cycles and power.
User and maintenance manual
Sheet 14 of 24
Date
18/ 02/ 2013
Rev. 01
Focusmed S.r.l. – Largo Traiano n.4 – Montegrotto Terme (PD) VAT number 04590310282
High-frequency and low-intensity device for dermatological and skin wound treatment, wound care and biostimulation
RINOVACELL® Patent application PD 2011A000385
g) Derm atological and skin w ound treatm ent, w ound care, biostim ulation
RINOVACELL® is extremely efficient in treating difficult wounds (wound care), bedsores,
diabetic feet, skin wounds/lesions in general, where biostimulation is needed, obviously
after appropriate diagnosis by the patient's doctor and instrumental diagnosis.
It has a notable anti-inflammatory and anti-edematous effect, in addition to
biostimulation of the extra-cell structures, activation of arterial and venolymphatic micro-circulation, excitation of chemical-enzymatic systems,
increase in capillary and pericapillary hyperemia, removal of tissue catabolites,
excellent in preventive treatment.
h) Contraindications
Although safety tests have not identified any significant values with respect to interference
with other devices, application of electric current and therefore use of RINOVACELL® is
not recommended, for the sake of caution, on people with:
Pace-makers
Malign tumours
Nodules
Pregnant women
Wearers of cerebral stimulation electrodes
Electric and/or electronic equipment in general
Part of these contraindications are based on the non-existence of cases of treated patients
suffering from these or other pathologies.
i) Protection m easures
The treatment cycle does not start when:
- the handpiece cable is disconnected;
- the Start button (on the touch screen) is not pressed.
The treatment cycle starts at minimum power when:
- the insulating mat is not connected to the black jack socket on the generator with the
special cable;
- If the handpiece plate/disc does not come into contact with the patient's tissue.
The treatment cycle is suspended when:
- the outgoing power supply circuits are out of control;
User and maintenance manual
Sheet 15 of 24
Date
18/ 02/ 2013
Rev. 01
Focusmed S.r.l. – Largo Traiano n.4 – Montegrotto Terme (PD) VAT number 04590310282
High-frequency and low-intensity device for dermatological and skin wound treatment, wound care and biostimulation
RINOVACELL® Patent application PD 2011A000385
- If the power terminals absorb more than the maximum admissible current;
- If the handpiece connector is disconnected.
IN THE CASE OF ANY PROBLEMS, STOP TREATMENT IMMEDIATELY.
SWITCH OFF THE DEVICE, UNPLUG IT AND CALL THE ASSISTANCE SERVICE
l) Use
1) Adjust emission power using the special symbols on the Touch screen;
2) Choose the emission frequency from the three available;
3) Adjust treatment time using the special symbols on the Touch screen;
4) Enable or disable the acoustic transmission signal, or adjust the volume, using the
specific keys;
5) Adjust the number of emission cycles;
6) Position the return mat under the patient (contact with the skin is not necessary)
and connect the mat to the connector on the lower right-hand side of
RINOVACELL® , using the cable with two banana terminals (black part on the
black jack socket on the lower right-hand side of RINOVACELL®, blue part on the
blue pipette on the mat);
7) Ensure that the handpiece chosen is connected to the specific connector (the
device indicates this on the touch screen under “STATUS”);
8) Press the Start button on the touch screen and check that the red Tx Led on the
cover switches on (near the green ON Led);
User and maintenance manual
Sheet 16 of 24
Date
18/ 02/ 2013
Rev. 01
Focusmed S.r.l. – Largo Traiano n.4 – Montegrotto Terme (PD) VAT number 04590310282
High-frequency and low-intensity device for dermatological and skin wound treatment, wound care and biostimulation
RINOVACELL® Patent application PD 2011A000385
9)
10)
11)
12)
13)
14)
15)
16)
17)
Position the handpiece plate on the tissues to be treated and check that the FWD
needle gradually moves towards the maximum (depending on the power chosen, the
needle stops in different zones, e.g. if power is 50%, it will be mid-curve, white
zone), and that the RL needle tends to drop towards the minimum (the closer to the
minimum it is, the more energy is absorbed by the patient);
Power supply always starts from the minimum possible and is adjusted on the basis
of the regulations made;
If there are anomalies in absorption of the high frequencies emitted, RINOVACELL®
automatically reduces the power to avoid causing damage to users and/or patients;
To obtain almost constant supply of high frequencies on the tissues being treated
during treatment, keep the plate of the handpiece (white plate/disc of the handpiece)
as close to the tissues as possible, even when moving it; if the RINOVACELL® plate is
raised, it immediately reduces the power emitted and supplies it again starting from
half the power set, until it finds the right adjustment for the tissues in just a few
seconds;
At the end of each cycle, RINOVACELL® emits an acoustic signal and starts the
subsequent cycle, if programmed;
The maximum supply time is 30 minutes per cycle; a maximum of 20 cycles may be
repeated, thus reaching the maximum 10 hours of supply and treatment;
To stop a cycle early, remove the handpiece plate/disc from the tissue being treated
and rest the handpiece on a flat surface. At this point, press the START button, after
which the device goes into PAUSE (the Start button turns yellow and the word
changes to PAUSE) in order to alter the parameters set (time, cycles, power,
handpiece); press the START button again (turned yellow with the word
PAUSE) to start again where you left off, so the treatment performed so far is not
lost. If you press STOP, the device resets: the time and cycles performed return to
zero and the treatment starts again from scratch;
No conducting creams or gels are necessary on the handpiece plate/disc or the mat.
Choose the handpiece according to the area to be treated, the patient's pathology
and the desired power.
User and maintenance manual
Sheet 17 of 24
Date
18/ 02/ 2013
Rev. 01
Focusmed S.r.l. – Largo Traiano n.4 – Montegrotto Terme (PD) VAT number 04590310282
High-frequency and low-intensity device for dermatological and skin wound treatment, wound care and biostimulation
RINOVACELL® Patent application PD 2011A000385
m) Precautions for use
RINOVACELL® uses high-frequency currents which close directly on the insulating mat. It
is therefore important for the patient to be sitting or lying on the mat, which is connected,
using the special cable, to the black jack socket on the lower right-hand side of the case.
Since no clinical data is available, do not use the device on the following classes of
patients:
a) Pregnant women;
b) Patients with heart diseases wearing pacemakers;
IMPORTANT
Since no studies are available, DO NOT use RINOVACELL® on patients with
active implantable medical devices (pacemakers, hearing-aids, cerebral
stimulation electrodes, etc.)
Clean and disinfect the discs before and after every use.
W ARNI NG! DO NOT use electro-m edical devices near children, as they could
injure them selves or cause dam age; tak e particular care in handling the
cables, as there could be a risk of strangulation.
W ARNI NG! K EEP OUT OF REACH OF CHI LDREN!
W ARNI NG! Alw ays lock the case/ container to prevent use by unqualified
people and/ or children.
IN THE CASE OF PROBLEMS (e.g.: setting difficulties, absence of power, low
power, leds not switching on, etc.), STOP THE TREATMENT IMMEDIATELY,
SWITCH OFF THE MACHINE, UNPLUG IT AND CALL THE ASSISTANCE SERVICE.
For use at home, the device is not class B, but this is an acceptable limit depending on the
benefit provided and in terms of both health/treatment and financial aspects. Said
disturbances are not dangerous for the operator or the patient and do not cause damage
to the household appliances with which they interfere.
User and maintenance manual
Sheet 18 of 24
Date
18/ 02/ 2013
Rev. 01
Focusmed S.r.l. – Largo Traiano n.4 – Montegrotto Terme (PD) VAT number 04590310282
High-frequency and low-intensity device for dermatological and skin wound treatment, wound care and biostimulation
RINOVACELL® Patent application PD 2011A000385
Maintenance
a) General inform ation
Due to its design and construction, RINOVACELL® requires:
1) an annual check on the outgoing power parameters by specialist technicians;
2) disinfection of the handpiece plates/discs:
3) daily check on the conditions of the cables and accessories.
ANNUAL CALIBRATIONS ARE ESSENTIAL FOR GOOD USE AND LONG LIFETIME OF THE
DEVICE AND ALSO FOR SUCCESSFUL TREATMENT.
b) Annual check
RINOVACELL® is an electronic instrument and must be checked annually to examine
calibration of the power parameters at the various emission levels and check functioning
of the safety controls.
Checking and calibration must be performed by authorised technical personnel using
appropriate testing equipment.
These operations are essential for good use and long lifetime of the device and also for
successful treatment.
RINOVACELL® has a 24-month warranty if the warranty labels placed on the device at the
factory are intact when the checks are performed (ESSENTIAL CONDITION FOR
MAINTAINING THE WARRANTY AND PLACING IN SERVICE).
(see warranty paragraph)
Before using Rinovacell®, check that less than 13 months have passed since the
last calibration date.
c) Cleaning and disinfection of the handpieces and relative screw -on plates and
discs
Clean and disinfect the handpieces and plates/discs before and after every use.
Use hot water and a neutral, non-corrosive detergent.
Do not use steel-wire or metal brushes, but only soft plastic brushes which do not scratch
the surface of the disc.
Perform manual cleaning carefully.
After washing, disinfect the discs using the normal disinfectants used at the healthcare
facility, with which they are compatible.
The doctor and/or user should decide the disinfectant to use on the basis of the patient's
pathology.
User and maintenance manual
Sheet 19 of 24
Date
18/ 02/ 2013
Rev. 01
Focusmed S.r.l. – Largo Traiano n.4 – Montegrotto Terme (PD) VAT number 04590310282
High-frequency and low-intensity device for dermatological and skin wound treatment, wound care and biostimulation
RINOVACELL® Patent application PD 2011A000385
The plates/discs are not damaged by normal disinfectants.
However, avoid immersing them in:
- Acetone
- Nitro thinners
- Trichloroethylene
- Acids of any nature and with a PH less than 6
- Basic components with a PH higher than 8
We recommended using disinfectant products such as:
- Duly thinned alcohol
- Ready to use disinfectants and anti-fungal products
- Thinned hypoochlorite products
- Hydrogen peroxide at low/medium volume
Minimum immersion time of 20 minutes.
DO NOT STERILISE AT HIGH TEMPERATURES
d) Daily check
Check RINOVACELL® daily and/or whenever the case/container is opened, taking
particular care to check the cables.
e) Handpieces and m at
Check RINOVACELL® daily and/or whenever the case/container is opened.
Pay particular attention to the varnished surface of the discs/plates and their colour; in
the case of doubts, replace the plate/disc with a new one (see handpiece section). Check
the fastener of the handpiece to be used and the connection to the mat, which must be
underneath the patient. The mat does not require contact with the patient's skin, or
conducting gels or creams.
User and maintenance manual
Sheet 20 of 24
Date
18/ 02/ 2013
Rev. 01
Focusmed S.r.l. – Largo Traiano n.4 – Montegrotto Terme (PD) VAT number 04590310282
High-frequency and low-intensity device for dermatological and skin wound treatment, wound care and biostimulation
RINOVACELL® Patent application PD 2011A000385
Warranty
As a generator, RINOVACELL® has a 24-month warranty if the warranty labels placed on
the device at the factory are intact when the checks are performed (ESSENTIAL
CONDITION).
Tampering with RINOVACELL® by unauthorised personnel invalidates the warranty and
the device cannot be placed in service anymore.
The handpieces have a 1-year warranty.
The handpiece discs/plates have a six-month warranty.
The mat and the RINOVACELL® generator connector cable have a six-month warranty.
The warranty only covers manufacturing defects and not breakage and/or damage from
wear and tear and/or faults/breakages caused by improper use, transport or storage, by
way of example.
The average lifetime of the device, calculating 5 hours of daily use, is eight years,
obviously with correct and regular maintenance.
Disposal
FOCUSMED Srl pays a great deal of attention to eco-compatibility and respect of nature.
RINOVACELL®, compatibly with operating and safety functions, has been designed and
constructed to have a minimum negative impact on the environment.
The applied criteria are those designed to limit waste, toxic materials, noise, undesired
radiation and energy consumption to a minimum.
Careful research into optimising performance of machines reduces consumption, in
accordance with the concepts of energy saving.
This symbol indicates that the product may be disposed of with domestic waste.
The user is responsible for disposal of devices to be scrapped, taking them to the
collection centre indicated for subsequent recycling of electric and electronic equipment.
User and maintenance manual
Sheet 21 of 24
Date
18/ 02/ 2013
Rev. 01
Focusmed S.r.l. – Largo Traiano n.4 – Montegrotto Terme (PD) VAT number 04590310282
High-frequency and low-intensity device for dermatological and skin wound treatment, wound care and biostimulation
RINOVACELL® Patent application PD 2011A000385
Annex 1: EMC tables
RINOVACELL® has been designed and constructed to satisfy ELECTROMAGNETIC
COMPATIBILITY standards. The EC mark also guarantees compliance with these standards. The
functioning principle of RINOVACELL® consists in generating a certain quantity of energy at
high-frequency and having a sufficient level of immunity to radiating electromagnetic fields. Users
must not alter the device or the cables (power cables and connection cables to the patient) in any
way, in order to avoid altering its electromagnetic behaviour and to avoid interference damaging
radio communications, functioning of electro-medical devices used for monitoring, diagnosis,
treatment and surgery, functioning of electronic office machines such as computers, printers,
photocopiers, fax machines, etc., and any electric or electronic device used in these environments,
considering the electromagnetic compatibility characteristics indicated in the tables below, which
satisfies EN 60601-1-2:
Emission test
RF emissions
Cispr 11
Emission aspects
Conformity
Electromagnetic environment - guide
RINOVACELL® emits electromagnetic energy
Class A Group 2
to perform its treatment functions. Equipment
nearby could be influenced by the fields
produced.
Harmonic emissions
IEC 61000-3-2
Class A
Compliant
Voltage fluctuations/flicker
emissions IEC 61000-3-3
Compliant
The device can be used in all buildings,
including residential buildings, and those
directly connected to the low voltage public
power network, which supplies power to
buildings for domestic uses.
User and maintenance manual
Sheet 22 of 24
Date
18/ 02/ 2013
Rev. 01
Focusmed S.r.l. – Largo Traiano n.4 – Montegrotto Terme (PD) VAT number 04590310282
High-frequency and low-intensity device for dermatological and skin wound treatment, wound care and biostimulation
RINOVACELL® Patent application PD 2011A000385
Immunity aspects
RINOVACELL® is designed to function in the electromagnetic environment indicated below. The
customer or user must ensure it is used in said environment.
Immunity test
Test level
Conformity
Electromagnetic environment
level
- guide
EN 60601-1-2
The flooring must be wood,
Electrostatic discharges ± 6kV on contact
± 6kV on contact
concrete or ceramic tile. If the
(ESD)
± 8kV in the air
± 8kV in the air
flooring is covered in synthetic
EN 61000-4-2
materials, relative humidity must be
at least 30%.
Electrical fast
transients/bursts
EN 61000-4-4
±2kV power
supply lines
±2kV power
supply lines
The quality of the mains voltage
should be the typical one for a
commercial or hospital environment.
It must comply with current
regulations in all cases.
Pulses
EN 61000-4-5
±1kV
differential
±1kV
differential
The quality of the mains voltage
should be the typical one
for a commercial or hospital
environment. It must comply with
current regulations in all cases.
< 5% UT
(>95% dip of UT)
for 0.5 cycles
The quality of the mains voltage
should be the typical one for a
commercial or hospital environment.
If the user requires continuous
functioning during a mains power
outage, the device should be
powered with an uninterruptible
power supply (UPS) or with batteries.
Voltage dips, short
< 5% UT
interruptions and voltage (>95% dip of UT)
variations
for 0.5 cycles
EN 61000-4-11
40% UT
(60% dip of UT)
for 5 cycles
Power frequency
magnetic field
EN 61000-4-8
40% UT
(60% dip of UT)
for 5 cycles
70% UT
(30% dip of UT)
for 25 cycles
70% UT
(30% dip of UT)
for 25 cycles
< 5% UT
(>95% dip of UT)
for 5 seconds
< 5% UT
(>95% dip of UT)
for 5 seconds
3 A/m
3 A/m
Power frequency magnetic fields
should have the characteristic levels
of a commercial or hospital
environment. It must comply with
current regulations in all cases.
User and maintenance manual
Sheet 23 of 24
Date
18/ 02/ 2013
Rev. 01
Focusmed S.r.l. – Largo Traiano n.4 – Montegrotto Terme (PD) VAT number 04590310282
High-frequency and low-intensity device for dermatological and skin wound treatment, wound care and biostimulation
RINOVACELL® Patent application PD 2011A000385
Radio frequency immunity
RINOVACELL® is designed to function in the electromagnetic environment indicated below. The
customer or user must ensure it is used in said environment.
Immunity test
Test level
Conformity
Electromagnetic environment - guide
EN 60601-1-2
level
Portable and mobile RF communication devices
Conducted RF
3 Veff from
3 Veff from
EN 61000-4-6
150kHz to 80MHz 150kHz to 80MHz should not be used close to any part of the
device, including the cables, unless the
Radiated RF
3 Veff from
3 Veff from
recommended minimum separation distances
80MHz
80MHz
EN 61000-4-3
are observed, calculated with the equation
to 2.5GHz
to 2.5GHz
applicable to the transmitter frequency.
Recommended separation distance
d = 1.2 ⋅√P from 150kHz to 80MHz
d = 1.2 ⋅√P from 80 MHz to 800MHz
d = 2.3 ⋅√P from 800 MHz to 2.5GHz
where P is the maximum rated output power of
the transmitter in Watt (W) according to the
transmitter manufacturer and is the
recommended separation distance in metres
( m ).
The intensity of the fixed RF transmitters, as determined by an electromagnetic survey of the site, could be
lower than the conformity level of each frequency range.
Interference may be checked close to devices carrying the following symbol:
User and maintenance manual
Sheet 24 of 24
Date
18/ 02/ 2013
Rev. 01
Focusmed S.r.l. – Largo Traiano n.4 – Montegrotto Terme (PD) VAT number 04590310282
High-frequency and low-intensity device for dermatological and skin wound treatment, wound care and biostimulation
RINOVACELL® Patent application PD 2011A000385
Recommended separation distance in metres between portable and mobile
radio communication devices and RINOVACELL®
RINOVACELL® is designed to function in an electromagnetic environment in which radiated RF disturbances are
controlled. The customer or user can contribute to preventing electromagnetic interference by ensuring a
minimum distance between mobile and portable RF devices (transmitters) and the device, as recommended
below, in relation to the maximum output power of the radio communication devices.
Maximum rated
output power of the
transmitter (W)
0.01
0.1
1
10
70
Separation distance at the transmitter frequency (m)
From 150kHz to
80MHz d = 1.2 ⋅√P
0.12 √
0.38
1.2
3.8
8
From 80MHz to
800MHz d = 1.2 ⋅√P
0.12 √
0.38
1.2
3.8
8
From 800MHz to
2GHz d = 2.3 ⋅√P
0.23 √
0.73
2.3
7.3
16
For transmitters with maximum rated output power not indicated above, the recommended separation distance d
in meters (m) may be calculated using the equation applicable to the transmitter frequency, where P is the
maximum rated output power of the transmitter in Watt (W), according to the transmitter manufacturer.
NB:
(1) At 80 MHz and 800 MHz the highest frequency range is applied
(2) These guidelines might not be applicable in all situations. Electromagnetic propagation is influenced by
absorption and reflection of structures, objects and people.