Beruflich Dokumente
Kultur Dokumente
FESMED IV 4054
FESMED
4052
4054
USER MANUAL
English
Version: 2
Table of Contents
02 .............Presentation
03 .............General Information
04 .............Symbols
05 ............Attention
09 .............Display Language
10 .............Controls
11 .............Control Functions
12 .............Operation Modes
32 .............Protocols
34 .............Indications
35 .............Contraindications
36 .............Electrode Application
38 .............Corrective maintenance
39 .............Technical Data
42 .............Declarations
46 .............Final Considerations
47..............European Representative
47 .............References
MU_4052_4054_ENG_Rev:02_092009
FESMED II 4052
FESMED IV 4054
FESMED II 4052
FESMED IV 4054
Presentation
General Information
04 Electrode cables
01 Users Manual
FESMED II 4052
02 Electrode cables
01 Users Manual
To buy optional accessories, please verify the codes at page 41, Additional
Accessories .
FES
The functional electrical stimulation is a form of electrotherapy that can
produce muscle contractions with functional objectives. The movements
produced by FES technique are fully controllable and provide the patient a
positive psychological attitude , as he/she uses his/her own muscles, which
contributes to his/her physical and emotional rehabilitation.
The regular application of the neuromuscular electrostimulation (NMES)
with FES has proved to be efficient in the treatment of patients with motor
deficiencies caused by different neurological pathologies. Some results
that may be obtained with the utilization of this technique are: reduced
muscle spasticity, muscle strengthening and improved gait pattern.
The equipment allows, for instance, quadriceps stimulation,
dorsiflexion movement and gait monitoring, among other resources.
TENS
Chronic pain - continued and debilitating pain, as those associated with
rheumatism, arthritis, sciatic nerve, among others, do not have the purpose
of indicating any eminent damage, but that we have a damage resulting
from the pathology itself. The treatment of chronic pains using narcotics and
other drugs always brings inconvenient side effects, almost always causing
as many problems as the pain itself.
TENS (Trancutaneous Electric Nerve Stimulation) promotes a simple, safe
and effective solution to chronic pain problems.
MU_4052_4054_ENG_Rev:02_092009
foot
MU_4052_4054_ENG_Rev:02_092009
FESMED II 4052
FESMED IV 4054
Symbols
Device symbols
FESMED II 4052
FESMED IV 4054
Packaging symbols
Caution fragile. Handle with care
Device is off
Keep in a dry place
Device is on
This symbol indicates the device causes
physiological effects and that the user should
check the users manual before using it.
IPX0
Class II equipment
Manufacturer Identification
European Representative
CE marking and identification of the notified
agency
MU_4052_4054_ENG_Rev:02_092009
ATTENTION
1. Read, understand and practice the operation and precaution
instructions. Know the limitations and dangers associated with use
of any electrical stimulation device.
2. Do not expose the device to direct sunlight radiated from
a heat
radiator, excessive quantities of dust,
humidity, vibrations and
mechanical shocks.
3. In the case of liquid infiltration, disconnect the device from the
power network and contact the Authorized Technical Assistance.
4. Before administering any treatment on a patient, you must become
acquainted with the operational procedures for each treatment
modality available, as well as the indications, contraindications,
warnings and precautions. Consult other resources to obtain further
information on the application of electrotherapy.
MU_4052_4054_ENG_Rev:02_092009
FESMED II 4052
FESMED IV 4054
FESMED II 4052
FESMED IV 4054
5. Operating sequence
WARNINGS:
Connect
equipment to the
power network
Turn on
equipment
through the
ON/OFF switch
Connect the
electrode cables
to the patient
MU_4052_4054_ENG_Rev:02_092009
Turn on the
equipment
through the
ON/OFF switch
MU_4052_4054_ENG_Rev:02_092009
FESMED II 4052
FESMED IV 4054
Electrical Installation/Connection
For a perfect device operation, we suggest electrical installations according
to the following rules:
Brazil:
NBR 5410/1990 Low-voltage electrical installations;
NBR13534/1995 Electrical installations at medical locations Safety requirements.
Other Countries:
IEC 60364-7-7 (10/2002) Electrical Installations medical
locations;
Or another related norm applicable in the utilization country.
FESMED II 4052
FESMED IV 4054
Remove the fuse compartment cover with the help of a screwdriver (insert
the tip into the fuse compartment groove, press down slightly and rotate
counterclockwise).
Display Language
FESMED offers display configuration in three possible idioms:
Portuguese
English
Spanish
If you want to change the current language, follow the steps below:
1.
2.
Connect one end of the power cable to the three-pole socket on the
rear panel and the other end to the wall outlet.
SN.: 00001
Figure 01
Your equipment uses switched power supply and operates at any volt
supply between 100 and 240VCA, 50 or 60Hz.
In case the protection fuse is blown, replace only with another one of
the indicated rating:
FESMED
405X
Rev.: X.Y
3.
4.
5.
6.
7.
MU_4052_4054_ENG_Rev:02_092009
MU_4052_4054_ENG_Rev:02_092009
FESMED II 4052
FESMED IV 4054
8.
The unit will exit the language selection mode, and the Main Menu will
be displayed.
FESMED II 4052
FESMED IV 4054
Control Functions
NEXT FIELD
Controls
Fesmed II 4052
INCREASES SETTING
DECREASES SETTING
PREVIOUS
FIELD
Fesmed IV 4054
MU_4052_4054_ENG_Rev:02_092009
10
MU_4052_4054_ENG_Rev:02_092009
11
FESMED II 4052
FESMED IV 4054
FESMED II 4052
FESMED IV 4054
- 60 to 200 Hz, in steps of 10 Hz
Operation Modes
FESMED 4052 and Fesmed 4054 can operate as stimulators with both
FES and TENS Techniques.
TENS
The wave form of TENS mode is the Balanced Symmetrical Two-Phase
Wave, as illustrated below:
T
12
CONTNUO
BURST
VIF
VLP
VLF
CONTNUO (Continuous)
In the operation mode, the device presents output continuous frequency
signal and variable pulse duration.
The Frequency value may be set between 1Hz and 200Hz, being: from
1Hz to 10Hz in steps of 1Hz; from 10Hz to 50 Hz in steps of 5 Hz and
from 50 Hz to 200 Hz in steps of 10 Hz).
The pulse duration may be set between 50 s and 400 s, in steps of 10
s.
BURST
In this operation mode, the device presents output continuous signal,
modulated by 2Hz frequency.
The output frequency is fixed at 100Hz, being modulated (interrupted)
by 2 Hz frequency.
The pulse duration may be set between 50 s and 400 s, in steps of 10 s.
VIF
In this operation mode, the device presents output signal with automatic
variation of Frequency and Pulse Width, i.e., the selected settings for
frequency and pulse width present variation of +25% within a period of 3
sec., then returning to the original setting, and variation of 25%, within a
period of 3 sec., then returning to the original setting. This cycle is repeated
indefinitely.
The frequency value may be set between 5Hz and 170Hz, being: from
5Hz to 10Hz in steps of 1Hz; from 10Hz to 50 Hz in steps of 5 Hz and
from 50 Hz to 170 Hz in steps of 10 Hz).
The pulse width value may be set between 70 s and 370 s, in steps of
10 s.
MU_4052_4054_ENG_Rev:02_092009
13
FESMED II 4052
FESMED IV 4054
VLP
In this operation mode, the device presents output signal with automatic
variation of pulse width, i.e., the selected setting for pulse width presents
variation of +25% within a period of 3 sec., then returning to the original
setting, and variation of 25%, within a period of 3 sec., then returning to
the original setting. This cycle is repeated indefinitely.
The frequency is fixed according to the selected setting (adjustable
between 1Hz and 200Hz).
The pulse duration varies +/- 25% of the selected setting (adjustable
between 70 s and 370 s).
FESMED II 4052
FESMED IV 4054
- 1 to 10 Hz, in steps of 1 Hz
- 10 to 50 Hz, in steps of 5 Hz
- 60 to 200 Hz, in steps of 10 Hz
Pulse Width settings are:
50 uS to 600 uS, in steps of 10 uS.
In FES mode the slope-up, holding, slope-down and stimulation slope rest
times can be selected as illustrated in the figures below:
VLF
In this operation mode, the device presents output signal with automatic
variation of frequency, i.e., the selected setting for frequency presents
variation of +25% within a period of 3 sec., then returning to the original
setting, and variation of 25%, within a period of 3 sec., then returning to
the original setting. This cycle is repeated indefinitely.
I(mA)
Freqncia =
Frequency
T
(Hz)
T = PerodoPeriod
The frequency varies +/- 25% of the selected value (adjustable between
5 and 170Hz).
The pulse duration is fixed according to the selected setting (adjustable
between 50 s and 400 s).
FES
Slope-up
Time
Holding
Time
Slopedown Time
Rest Time
14
15
FESMED II 4052
FESMED IV 4054
FESMED II 4052
FESMED IV 4054
Synchron
Sequential
Alternate
Reciprocal
FES
SEQUENCIAL (sequential)
PROTOCOlS
ALTERNADO (alternate)
The channels are enabled independently. Channels 1, 2, 3 and 4
are enabled and disabled sequentially.
RECIPROCO (reciprocal) (Fesmed IV 4054 only)
In Fesmed II 4052, channels 1 and 2 are enabled alternately.
In Fesmed IV 4054, channel pairs 1 & 2 and 3 & 4 are enabled
alternately.
Or PROTOCOLS mode.
PROTOCOLS
TENS
Turn on the unit using the ON / OFF switch on the rear panel.
PROTOCOLS
FES
PROTOCOLS
TENS
SN.: 00XXX
FESMED 4054
Rev.: X.Y
TENS
Normal
Burst
VIF
VLP
VP
FES
PROTOCOLOS
PROTOCOLOS
Normal
Burst
VIF
VLP
VP
TENS
Timer
Normal
10 m 00 s
Frequency
Pulse Widt
100 Hz
100 uS
FES
0
MU_4052_4054_ENG_Rev:02_092009
Normal
Burst
VIF
VLP
VP
TENS
Normal
Burst
VIF
VLP
VP
FES
Device Operation:
FES
16
MU_4052_4054_ENG_Rev:02_092009
0
17
FESMED II 4052
FESMED IV 4054
Press
to
enable the selected mode.
TENS
Timer
Normal
10 m 00 s
Frequency
Pulse Widt
100 Hz
100 uS
Normal
15 m 00 s
Frequency
Pulse Widt
100 Hz
100 uS
Normal
15 m 00 s
Frequency
Pulse Widt
100 Hz
100 uS
Normal
15 m 00 s
Frequency
Pulse Widt
100 Hz
100 uS
MU_4052_4054_ENG_Rev:02_092009
TENS
Timer
Normal
15 m 00 s
Frequency
Pulse Widt
100 Hz
100 uS
18
Normal
15 m 00 s
Frequency
Pulse Widt
100 Hz
200 uS
TENS
Timer
Out put
ON
Frequency
Pulse Widt
0
Normal
15 m 00 s
150 Hz
200 uS
Press
to enable the output channels.
Sada Acionada (Output Enabled) will be displayed and the selected time
will be decreased every second.
.
To disable the outputs, press
Use the intensity control keys to increase or decrease the intensity:
TENS
Timer
Output
ON
Frequency
Pulse Widt
TENS
Timer
TENS
Timer
TENS
Timer
TENS
Timer
FESMED II 4052
FESMED IV 4054
Normal
15 m 00 s
100 Hz
200 uS
MU_4052_4054_ENG_Rev:02_092009
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FESMED II 4052
FESMED IV 4054
FESMED II 4052
FESMED IV 4054
To start a new therapy, select the desired time, check whether the
Frequency and Pulse Width parameters are correct; otherwise, change the
TENS
Normal
Burst
VIF
VLP
VP
FES
PROTOCOLS
TENS
Synchron
Sequential
Alternate
Reciprocal
FES
Press
to
enable the selected mode.
FES
Frequency
Pulse Widt
Slope / \ __
Synchron
10 m 00 s
100 Hz
100 uS
0: 1:0 : 1s
0
Use the arrow keys
to set the Frequency value:
20
MU_4052_4054_ENG_Rev:02_092009
Synchron
15 m 00 s
180 Hz
100 uS
0: 1:0 : 1s
0
Synchron
15 m 00 s
Frequency
Pulse Widt
Slope / \ __
180 Hz
100 uS
0: 1:0 : 1s
FES
Timer
Synchron
15 m 00 s
Frequency
Pulse Widt
Slope / \ __
MU_4052_4054_ENG_Rev:02_092009
FES
Timer
PROTOCOLS
100 Hz
100 uS
0: 1:0 : 1s
FES
Timer
Frequency
Pulse Widt
Slope / \ __
Synchron
15 m 00 s
Frequency
Pulse Widt
Slope / \ __
PROTOCOLS
TENS
100 Hz
100 uS
0: 1:0 : 1s
FES
Timer
Synchron
Sequential
Alternate
Reciprocal
Synchron
10 m 00 s
Frequency
Pulse Widt
Slope / \ __
PROTOCOLS
TENS
FES
Timer
180 Hz
100 uS
0: 1:0 : 1s
21
FESMED II 4052
FESMED IV 4054
FESMED II 4052
FESMED IV 4054
FES
Timer
FES
Timer
Synchron
15 m 00 s
Frequency
Pulse Widt
Slope / \ __
180 Hz
400 uS
0: 1:0 : 1s
FES
Timer
180 Hz
400 uS
9: 1:0 : 1s
FES
Timer
180 Hz
400 uS
9 : 30 : 0 : 1 s
FES
Timer
180 Hz
400 uS
9 : 30 : 9 : 30 s
22
Press
to enable the output channels.
Sada Acionada (Output Enabled) will be displayed and the selected time
will be decreased every second.
FES
Timer
Output
ON
Frequency
Pulse Widt
Slope / \ __
Synchron
14 m 59 s
180 Hz
400 uS
9 : 30 : 9 : 30 s
MU_4052_4054_ENG_Rev:02_092009
Synchron
15 m 00 s
Frequency
Pulse Widt
Slope / \ __
180 Hz
400 uS
9 : 30 : 0 : 1 s
180 Hz
400 uS
9 : 30 : 0 : 1 s
FES
Timer
Synchron
15 m 00 s
Frequency
Pulse Widt
Slope / \ __
0
Synchron
15 m 00 s
Frequency
Pulse Widt
Slope / \ __
Frequency
Pulse Widt
Slope / \ __
Synchron
15 m 00 s
Frequency
Pulse Widt
Slope / \ __
Synchron
15 m 00 s
MU_4052_4054_ENG_Rev:02_092009
23
FESMED II 4052
FESMED IV 4054
FESMED II 4052
FESMED IV 4054
Synchron
14 m 59 s
FES
180 Hz
400 uS
9 : 30 : 9 : 30 s
After the set time is expired, a sound warning will be heard, and the
intensities will be reset to zero.
To start a new therapy, select the desired time, check whether the
Frequency and Pulse Width parameters are correct; otherwise, change the
Normal
Burst
VIF
VLP
VP
PROTOCOLS
Normal
Burst
VIF
VLP
VP
TENS
FES
Turn on the unit using the ON / OFF switch on the rear panel.
PROTOCOLS
TENS
SN.: 00XXX
TENS
MU_4052_4054_ENG_Rev:02_092009
TENS
FES
FES
PROTOCOLS
PROTOCOLS
TENS
Synchron
Sequential
Alternate
Normal
Burst
VIF
VLP
VP
FES
PROTOCOLS
Normal
Burst
VIF
VLP
VP
FES
PROTOCOLS
24
MU_4052_4054_ENG_Rev:02_092009
25
FESMED II 4052
FESMED IV 4054
Press
to
enable the selected mode.
TENS
Timer
Normal
10 m 00 s
Frequency
Pulse Widt
100 Hz
100 uS
TENS
Timer
Normal
10 m 00 s
Frequency
Pulse Widt
100 Hz
100 uS
0
Use the arrow keys
to select Timer:
TENS
Timer
Normal
15 m 00 s
Frequency
Pulse Widt
100 Hz
100 uS
0
Use the arrow keys
to set the time.
TENS
Timer
Normal
15 m 00 s
Frequency
Pulse Widt
100 Hz
100 uS
Normal
15 m 00 s
Frequency
Pulse Widt
150 Hz
100 uS
TENS
Timer
Normal
15 m 00 s
Frequency
Pulse Widt
150 Hz
100 uS
TENS
Timer
Normal
15 m 00 s
Frequency
Pulse Widt
150 Hz
200 uS
Press
to enable the output channels.
TENS
Timer
Output
Frequency
Pulse Widt
Normal
15 m 00 s
ON
Normal
15 m 00 s
mA
150 Hz
200 uS
0
26
150 Hz
200 uS
Sada Acionada (Output Enabled) will be displayed and the selected time
will be decreased every second.
TENS
Timer
0
MU_4052_4054_ENG_Rev:02_092009
FESMED II 4052
FESMED IV 4054
MU_4052_4054_ENG_Rev:02_092009
27
FESMED II 4052
FESMED IV 4054
FESMED II 4052
FESMED IV 4054
FES
Timer
To start a new therapy, select the desired time, check whether the
Frequency and Pulse Width parameters are correct; otherwise, change the
settings and press
TENS
Normal
Burst
VIF
VLP
VP
FES
PROTOCOLS
100 Hz
100 uS
0: 1:0 : 1s
Synchron
15 m 00 s
Frequency
Pulse Widt
Slope / \ __
100 Hz
100 uS
0: 1:0 : 1s
FES
Timer
PROTOCOLS
Synchron
Sequential
Alternate
FES
PROTOCOLS
Synchron
15 m 00 s
Frequency
Pulse Widt
Slope / \ __
100 Hz
100 uS
0: 1:0 : 1s
FES
Timer
TENS
Synchron
Sequential
Alternate
FES
Frequency
Pulse Widt
Slope / \ __
FES
Timer
Synchron
10 m 00 s
Synchron
Sequential
Alternate
FES
Synchron
15 m 00 s
Frequency
Pulse Widt
Slope / \ __
180 Hz
100 uS
0: 1:0 : 1s
PROTOCOLS
FES
Timer
FES
Timer
Press
to
enable the selected mode.
Synchron
10 m 00 s
Frequency
Pulse Widt
Slope / \ __
100 Hz
100 uS
0: 1:0 : 1s
0
MU_4052_4054_ENG_Rev:02_092009
Synchron
15 m 00 s
Frequency
Pulse Widt
Slope / \ __
180 Hz
100 uS
0: 1:0 : 1s
28
MU_4052_4054_ENG_Rev:02_092009
29
FESMED II 4052
FESMED IV 4054
FES
Timer
Synchron
15 m 00 s
Frequency
Pulse Widt
Slope / \ __
180 Hz
400 uS
0: 1:0 : 1s
FES
Timer
Synchron
15 m 00 s
Frequency
Pulse Widt
Slope / \ __
180 Hz
400 uS
9: 1:0 : 1s
FES
Timer
Synchron
15 m 00 s
Frequency
Pulse Widt
Slope / \ __
180 Hz
400 uS
9 : 30 : 9 : 1 s
FES
Timer
Synchron
15 m 00 s
180 Hz
400 uS
9 : 30 : 9 : 30 s
30
FES
Timer
Synchron
15 m 00 s
Frequency
Pulse Widt
Slope / \ __
180 Hz
400 uS
9 : 30 : 9 : 30 s
Press
to enable the output channels.
Output ON (Output Enabled) will be displayed and the selected time will
be decreased every second.
FES
Timer
Output
ON
Frequency
Pulse Widt
Slope / \ __
Synchron
14 m 59 s
180 Hz
400 uS
9 : 30 : 9 : 30 s
0
Synchron
15 m 00 s
Frequency
Pulse Widt
Slope / \ __
FES
Timer
180 Hz
400 uS
9 : 30 : 0 : 1 s
Frequency
Pulse Widt
Slope / \ __
FESMED II 4052
FESMED IV 4054
Synchron
14 m 59 s
180 Hz
400 uS
9 : 30 : 9 : 30 s
31
FESMED II 4052
FESMED IV 4054
After the set time is expired, a sound warning will be heard, and the
intensities will be reset to zero.
To start a new therapy, select the desired time, check whether the
Frequency and Pulse Width parameters are correct; otherwise, change the
settings and press
FESMED II 4052
FESMED IV 4054
B) Store Protocol
To store a protocol, select the desired parameters in FES or TENS mode.
Ex.: FES Protocol, Alternate mode, FESMED IV.
FES
Timer
Protocols
Alternate
15 m 00 s
Frequency
Pulse Widt
Slope / \ __
A) Protocol Selection
180 Hz
400 uS
9 : 30 : 9 : 30 s
TENS
FES
Press
Press
.
The storing screen will be displayed:
PROTOCOLS
PROTOCOLS
XXXXX
YYYYY
ZZZZZ
STP TO DEL
FES
1 2 3 4 5
a b c d e
k l mn o
u v wx y
Stp to DEL
6
f
p
z
7
g
q
8
h
r
,
9 0
i j
s t
.
Press
Or press
to
Return to the main menu.
Normal
Burst
VIF
VLP
VP
FES
PROTOCOLS
Press
and
to confirm or
to select a letter.
to delete.
Note : The Fesmed allow you to record more than 30 Protocols in your
memory.
MU_4052_4054_ENG_Rev:02_092009
32
MU_4052_4054_ENG_Rev:02_092009
33
FESMED II 4052
FESMED IV 4054
C) Delete Protocol
Press
PROTOCOLS
XXXXX
YYYYY
ZZZZZ
STP TO DEL
FES
PROTOCOLS
XXXXX
YYYYY
ZZZZZ
Press
to confirm, or
Press
TENS
to
Use the arrow keys
select the desired PROTOCOL.
Press a
FESMED II 4052
FESMED IV 4054
STP TO DEL
FES
Delet. ?
Enter= YES
Menu = NO
Indications
Acute or chronic painful processes (overcoming the pain until its cause is
securely identified):
cervical-dorsal-lumbar pains
lumbar sciatic pains, trigeminal neuralgias
brachialgias
surgical wound pains
headache and articulation pains
patients submitted to surgery and required to mobilize corporal
segments traumatized during surgical operation
pulmonary re-expansion after thorax or abdomen surgery
limb mobilization
in cases of segment amputations
bursitis
traumatized limbs, plus hundreds of acute or chronic painful conditions.
Contraindications
FES
The functional electrical stimulation may be widely used as an aid in clinical
treatments of neuromuscular system and skeletal muscle problems. In the
presence of inactivity in peripheral nerve excitability, an external source of
FES
There are few specific contraindications for the therapeutic utilization of
electrical stimulation. One of them is the presence of heart pacemaker. The
MU_4052_4054_ENG_Rev:02_092009
MU_4052_4054_ENG_Rev:02_092009
34
35
FESMED II 4052
FESMED IV 4054
FESMED II 4052
FESMED IV 4054
For securing electrodes with gel, or moist sponges, to the patients skin, a
medical adhesive tape or elastic band may be used.
TENS
No contraindications for TENS utilization are known so far. However, the
following applications should be avoided:
patients with Heart or Brain Pacemaker;
patients with heart problems;
patients with epilepsy;
lumbar and abdominal regions - in the first three months of pregnant
patients;
carotid arteries in the breast region.
Electrode Application
Attention:
Self-Adherent Electrode
Electrolytic Effect
Current Density
FESMED presents constant current at the current output, which may cause
unpleasant reactions if the electrodes are not correctly attached to the skin
or if skin contact has been lost.
Be sure the output is reading 0 (zero) mA when attaching or removing
electrodes.
MU_4052_4054_ENG_Rev:02_092009
MU_4052_4054_ENG_Rev:02_092009
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37
FESMED II 4052
FESMED IV 4054
Preventive maintenance, conservation and cleaning
FESMED II 4052
FESMED IV 4054
sensation is higher with an electrode
than with another.
Check the patients sensitiveness.
The intensity is at maximum setting
Change the silicone or adherent
and the patient feels little stimulation.
electrodes.
When increasing the intensity (above
10 mA), the Beep start, and the
lettler M is displayed on the right
side of the intensity.
CAUSE: Low level current detected
when applied in the patient.
Corrective maintenance
Important Notes:
The corrective maintenance of this device, besides those prescribed above, should
be performed only by CARCI authorized professionals.
Electrical connections, circuits and part list are not supplied to end consumers. If
required, contact CARCI Authorized Technical Service.
Problems
Solutions
The device does not turn on.
MU_4052_4054_ENG_Rev:02_092009
38
Technical Data
Made by
Models
Function and Application
Power supply
Maximum Consumption
ANVISA registration
: CARCI Brazil
: FESMED II 4052 and FESMED IV 4054
: Electrotherapy device
: 100230 V~ automatic ( 10%)
: 50 / 60 Hz
: 25 VA
: AM-10314290017
MU_4052_4054_ENG_Rev:02_092009
39
FESMED II 4052
FESMED IV 4054
---------------------------------------------------------------------------------------------------
Classification according to NBR IEC 60601.1 and NBR IEC 60601.2.10
rules:
- Type of protection against electrical shocks:.....................
class II
- Protection level against electrical shocks of the applied part: BF type
- Protection level against harmful water penetration:
IPX0
- Disinfection methods:
see preventive maintenance
- Safety degree of application in the presence of anesthetic mixture inflammable
with air, oxygen or nitrous oxide:
not applicable
- Operation mode:
continuous
---------------------------------------------------------------------------------------------------
Fuse
: 1.0 A 250 V 20 AG
Dimensions
: 31 x 6 x 18 (WxHxD) (cm)
Weight
: 2.6 kg
Overcurrent protection
Slope-up/slope-down time
: 0 to 9 s
Pulse duration
: 50 to 600 us
Pulse frequency
: 1 to 200 Hz
TENS Mode Programming
Parameters of channels:
Pulse frequency
: 1 to 200Hz
Pulse duration
: 50 to 400 us
Operation modes:
Contnuo
: adjustable frequency and duration
Burst
: Ton : 1s - Toff : 1s with adjustable frequency and
duration
VIF
: adjustable and variable frequency and duration
VF
: adjustable and variable frequency, adjustable
duration
VLP
: adjustable and variable duration, adjustable
frequency
MU_4052_4054_ENG_Rev:02_092009
40
FESMED II 4052
FESMED IV 4054
Operating conditions of the device:
Ambient temperature
: +10C to +40C
Relative humidity
: 0% to 80%
Air pressure
: 700 hPa to 1060hPa
Environmental conditions for transport and storage:
o
Room temperature
: -10C to 60 C
Relative humidity
: 20% to 90%
Air pressure
: 500hPa to 1060hPa
Accessories
FESMED IV 4054
Silicone electrodes 3 x 5 cm
Electrode cables
Yellow
Green
Blue
purple
Users Manual
Contact gel
FESMED II 4052
Silicone electrodes 3 x 5 cm
Electrode cables
Green
Blue
Users Manual
Contact gel
Code 04033
Code 21305G
Code 21306G
Code 20307G
Code 21308G
Code 14747G
Code 10395G
Code 7000/200
Code 04033
Code 21306G
Code 20307G
Code 14747G
Code 10395G
Code 7000/200
41
FESMED II 4052
FESMED IV 4054
FESMED II 4052
FESMED IV 4054
Immunity tests
According to
MU_4052_4054_ENG_Rev:02_092009
42
Compliance
level
Electrostatic
discharge
IEC 61000-4-2
6 kV contact
8 kV air
Fast transients /
Blasts
IEC 61000-4-4
2 kV power
supply line
1 kV signal
input and output
line
Surge
IEC 61000-4-5
1
kV
differential mode
2 kV common
mode
1
kV
differential
mode
2 kV common
mode
<5% Ut
(>95%
Ut
reduction)
For 0.5 cycle
<5% Ut
(>95%
Ut
reduction)
For 0.5 cycle
40% Ut
(60%
reduction)
For 5 cycles
40% Ut
(60%
Ut
reduction)
For 5 cycles
Declarations
MANUFACTURERS DECLARATION AND INSTRUCTION
ELECTROMAGNETIC EMISSIONS
Test level of
IEC 60601
Voltage failures,
short
interruptions
and voltage
variations in
power supply.
IEC 61000-4-11
6 kV contact
8 kV air
Ut
2 kV power
supply
Not applicable
70% Ut
(30%
Ut
reduction)
For 25 cycles
70% Ut
(30%
Ut
reduction)
For 25 cycles
<5% Ut
(>95%
reduction)
For 5 s
<5% Ut
(>95%
reduction)
For 5 s
Ut
Electromagnetic
environment instructions
The floor should be made
of wood, concrete or
ceramic. If covered with
synthetic
material,
the
relative air humidity should
be min. 30%.
MU_4052_4054_ENG_Rev:02_092009
Ut
43
FESMED II 4052
FESMED IV 4054
Magnetic fields
of utility
frequencies
(50/60 Hz)
IEC 61000-4-8
3 A/m
3 A/m
Note: Ut is the utility voltage C.A before the test level application.
Portable and mobile devices of RF
communications should not be
used closer to any FESMED part including cables - than the distance
recommended
as
calculated
through the equation applicable to
the transmitter frequency.
Recommended distance:
d = 1,17. P
Conducted
RF
IEC 61000-46
d = 1,17. P
3 Vrms
150 kHz to
80 MHz
80 MHz to 800
MHz
GHz
Irradiated RF
IEC 61000-43
3 V/m
80 MHz to
2.5 GHz
3 V/m
MU_4052_4054_ENG_Rev:02_092009
NOTE 1: within the of 80 MHz and 800 MHz, the highest range frequency should be
applied.
NOTE 2: This procedure may not be applicable to all situations. The electromagnet
propagation is affected by absorption and reflection of structures, objects and
people.
a. The intensity of fields generated by fixed transmitters, such as telephone radiobase (mobile/wireless) and land mobile radio stations, amateur radio stations
and AM, FM and TV radiobroadcast stations cannot be theoretically identified
with precision. In order to evaluate the electromagnetic environment caused by
fixed RF transmitters, a study on the site electromagnetic field should be taken
into account. If the field intensity measured at the site where FESMED is used
exceeds the compliance level above, FESMED should be checked for normal
operation. If abnormal performance is observed, additional measures should be
taken, such as FESMED reorientation or reallocation;
b. For any value above the frequency scale of 150 kHz to 80 MHz, the field
intensity should be less than 3 V/m.
Distances recommended between portable and mobile RF communications
devices and FESMED
3V
d = 2,3. P
FESMED II 4052
FESMED IV 4054
44
80 MHz to 800
MHz
d = 1,17 P
d = 1,17 P
d = 2,3 P
0.01
11.70 cm
11.70 cm
23.00 cm
0.1
37.00 cm
37.00 cm
72.70 cm
1
1.17 m
1.17 m
2.30 m
10
3.70 m
3.70 m
7.27 m
100
11.70 m
11.70 m
23.00 m
For transmitters with declared value of max. output power not listed above, the
recommended distance (d in meters) may be determined through the equation
applicable to the transmitter frequency, where P is the max. output power of the
transmitter in watts (W), according to the transmitter manufacturer.
MU_4052_4054_ENG_Rev:02_092009
45
FESMED II 4052
FESMED IV 4054
NOTE 1: between 80 MHz and 800 MHz: the highest frequency distance should be
applied.
NOTE 2: this procedure may be applied to all situations. The electromagnet
propagation is affected by absorption and reflection of structures, objects and
people.
FESMED II 4052
FESMED IV 4054
European Representative
OBELIS SA
34, Av. de Tervuren, bte 44
B 1040 Brussels , BELGIUM
Tel: (32) 2.732.59.54
Fax: (32) 2.732.60.03
Final Considerations
Carcis policy is to continuously improve the quality of its products. Carci
reserves the right to make changes in the product project and
specifications, as well as add and improve its products, which should not
incur any obligation to install such changes in products already
manufactured.
The text, illustrations and specifications contained in this manual are based
on information available at the printing moment.
All rights reserved.
This manual should not be reproduced wholly or partly, without Carcis
authorization in writing.
Manufacturers Information
CARCI Indstria e Comrcio de Aparelhos Cirrgicos e Ortopdicos Ltda.
CGC: 61.461.034/0001-78
I.E. : 110.182.450.113
Rua lvares Fagundes, 359 So Paulo SP Brazil 04338-000
Tel.: (0XX11) 3346 2100
web site : www.carci.com.br
E-mail: carci@carci.com.br
E-mail: mail@obelis.net
W AR R A N T Y C E R T I F I C AT E I N AN N E X
References
1.
2.
3.
4.
5.
MU_4052_4054_ENG_Rev:02_092009
46
6.
7.
8.
9.
nd
MU_4052_4054_ENG_Rev:02_092009
47
FESMED II 4052
FESMED IV 4054
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MU_4052_4054_ENG_Rev:02_092009
48
FESMED II 4052
FESMED IV 4054
24. Sodipo Joa, Adedeji SA, Olumide O: Postoperative pain relief by
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pain relief during labor: A controlled Study. Ann Chir Gynaecol
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pain. Clin Orthorp 179:24-30,1983.
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knee with transcutaneous never stimulation. Pain 11:233-240,
1981.
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MU_4052_4054_ENG_Rev:02_092009
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