IACER I-TECH T-ONE COACH User manual

USER MANUAL
Electrotherapy model
T-ONE COACH

iii
Index
INDEX III
TECHNICAL INFORMATION 5
MANUFACTURER 5
DECLARATION OF CONFORMITY 5
CLASSIFICATION 6
PURPOSE AND SCOPE 6
TECHNICAL CHARACTERISTICS 6
DEVICE AND COMMANDS DESCRIPTION 7
LABELS 8
Packaging content 9
HOW TO USE 11
CONTRAINDICATIONS 11
WARNING 11
DEVICE USE 12
Main menu and single/multi patient selection 12
Preliminary settings 13
Single patient pre-set programs 13
Tips on how to adjust the intensity 16
LIST AND CHARACTERISTICS OF THE PROGRAMS AVAILABLE IN SINGLE PATIENT MODE 17
TENS Programs 17
Main pathologies summary table 24
NEMS programs 26
Treatment programs for muscle strength 36
BEAUTY programs 37
Treatment plans for muscle firming and lipolysis 47
LIST AND CHARACTERISTICS OF THE PROGRAMS AVAILABLE IN MULTI PATIENT MODE 48
LAST 10 PROGRAMS USED 51
SELECTING THE LANGUAGE AND RESTORING THE DEVICE TO FACTORY SETTINGS 52
DEVICE CARE 53
MAINTENANCE 53
TROUBLESHOOTING 53
Charging the batteries 55
Replacing the batteries 55
DISPOSAL 56

iv
WARRANTY 57
Support 58
Spare part 58
ELECTROMAGNETIC INTERFERENCES AND ELECTROMAGNETIC COMPATIBILITY TABLES 58

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Technical information
Manufacturer
I.A.C.E.R. S.r.l.
Via S. Pertini, 24/a • 30030 Martellago (VE)
Tel. [phone] • Fax [phone]
IACER S.r.l. is an Italian manufacturer of medical devices (certified CE no.
0068/QCO-DM/234-2020 from the Notified Body n° 0068 MTIC InterCert
S.r.l.).
Declaration of conformity
I.A.C.E.R. S.r.l
Via S.Pertini 24/A – 30030 Martellago (Ve), Italia
herewith declares under its own responsibility, that the family of products
T-ONE
which includes the following models
Rehab, Medi Pro, Medi Sport and Coach
UMDNS Code: 13762
has been designed and manufactured according to the European Medical
Device Directive 93/4/EEC (transposed in Italy by the D.Lgs. 46/97), as
modified by the Directive 2007/47/EC (D.Lgs.37/2010) and further
modifications/integrations.
The products have been assigned to class IIa, according to Annex IX, rule 9 of
the Directive 93/42/EEC (and further modifications/integrations) and bear the
mark
Compliance of the concerned products with the Directive 93/42/EEC has been
assessed and certified by the notified body:
0068 – MTIC InterCert S.r.l.
Via G. Leopardi 14, Milano (MI) 20123, Italia
Certified number: 0068/QCO-DM/234-2020
following the certification procedure according to Annex II (excluding point 4)
of the Directive 93/42/EEC.
________________ _____________________
Place, date Legal Representative
MASSIMO MARCON
Martellago, 03/08/2020

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Classification
The T-ONE COACH has the following classification:
•class IIa (Directive 93/42/CEE, Annex IX, rule 9 and further
amendments/additions);
•class II with BF type applied part (classif. EN 60601-1);
•equipment protection level IP22 against liquid and dust penetration;
•equipment and accessories not subject to sterilization;
•equipment unsuitable for use in presence of a flammable anesthetic
mixture containing air, oxygen and nitrous oxide;
•equipment suitable for continuous operation;
•equipment unsuitable for outdoors use.
Purpose and scope
Clinical intended use: Therapeutic
Environmental intended use: Ambulatory and home
T-ONE COACH è studiato ed indicato per:
•TENS therapy: pain relief treatments for the skeletal and muscular
system and for the articular system.
•NEMS: programs for professional and amateur sportive use
•BEAUTY: body care and beauty programs
The patient population intended for electrotherapy treatment using the T-
ONE COACH device includes patients of both sexes, men and women, of age
(unless otherwise indicated by medical doctors). For further details, please
refer to the Contraindications section.
The CE0068 mark is only for the medical programs (see the following
paragraphs related to the detailed description of the programs).
Technical characteristics
Characteristics
Specifica
Power supply
Batteries Ni-MH, 4.8V, 2300mAh
Recharger
Model AKN1G-0680030VW
Input AC 100-240V, 50-60Hz, 0.2A
Output DC 6.8V 0.3A
Isolation class (EN 60601-1)
II
Applied part (EN 60601-1)
BF
Dimensions (length x depth x
153x91x38 mm

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Characteristics
Specifica
height)
Weight
295 g with battery
Max output current
120mA on 1KΩ
Wave type
Compensated biphasic square wave and
monophase square wave
Wave frequency
From 1 to 150Hz
Pulse width
From 20µs to 300µs
Therapy time
Pre-adjusted
WARNING: the device has an output current over 10mA.
Expected useful life of the device is set in 3 years, meanwhile the expected
useful life of the electrodes is set in 10/15 uses.
Device and commands description
1. Front panel
2. Colour graphic display
3. Keypad
Start and return to program selection menu button
OK, end of program key

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Selection/increasing intensity of active channels key
Selection/decrease intensity of active channels key
Left selection key
Right selection key
Increase intensity on channel 1 (blue)
Decrease intensity on channel 1 (blue)
Increase intensity on channel 2 (yellow)
Decrease intensity on channel 2 (yellow)
Increase intensity on channel 3 (red)
Decrease intensity on channel 3 (red)
Increase intensity on channel 4 (white)
Decrease intensity on channel 4 (white)
4. Charging port
5. Battery compartment
6. Channel ports (1-4)
Labels
Symbol
Description
Manufacturer’s logo.

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Symbol
Description
Product CE certification released by Notified Body n°0068.
Manufacturer.
Manufacturing date (YYYY-MM).
Read instructions for use.
The product must be disposed as “electronic waste”, in
accordance to WEEE Directive on waste electrical and
electronic equipment.
Class II device
Applied part type BF
Temperature humidity (temperature
of the storage
environment, on the package).
Limits of relative humidity (relative humidity of the storage
environment, on the package).
IP22
Medical device protected against the penetration of solids
(with a diameter d≥12,5mm) and against the vertical drops
when the device is kept at 15° from its normal functioning
position.
Packaging content
The T-ONE COACH packaging contains:
-n° 1 device;
-n° 1 battery pack (inside the device);
-n°1 battery charger;
-n° 4 cables for electro-stimulation;
-n° 1 sets of 4 square pre-gelled electrodes;
-n° 1 set of 4 rectangular pre-gelled electrodes;
-n° 1 set of 8 round electrodes;

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-n° 1 bag for the transportation;
-n° 1 user manual;
-n° 1 user manual of the electrodes’ positions.

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How to use
Contraindications
No significant side effects are known. In some cases of particularly sensitive
people, skin redness occurs at the electrodes after treatment: the redness
normally disappears few minutes after treatment. If the redness persists,
consult a doctor.
In some rare cases evening stimulation causes some difficulties in falling
asleep. If this occurs, stop carrying out the treatment in the evening.
However, this device should not be used by pregnant women, children,
patients suffering from tuberculosis, juvenile diabetes, viral diseases (acute
phase), fungal infections, dermatitis, heart diseases, severe arrythmia, acute
infections, epilepsy or by patients with pacemakers, open wounds, magnetic
prosthesis (unless otherwise prescribed by the doctor). Do not use the device
if the source of the pain is unknown or not diagnosed. Use the device ONLY
after having a diagnosis. In the event of injury, muscle stress or any other health
problem consult your doctor before using the device and only use it under
medical supervision.
Warning
It is recommended:
•to control position and meaning of all the labels on the equipment;
•not to damage the connection cables to the electrodes and to avoid
winding the cables around the device;
•Do not use the device if it or any of its accessories are damaged
(damaged cables): contact the manufacturer as indicated in paragraph
Support;
•to avoid the use of the device by persons who did not read carefully this
manual;
•avoid use in damp environments;
•not to wear metal objects during treatment.
It is forbidden:
•to position the electrodes in such a way that the current crosses the
heart area (e.g. a black electrode on the chest and a red electrode on
the shoulder blade);
•to position the electrodes on or close to skin injuries or cuts;
•to position the electrodes on the carotid sinuses (carotid) or genitals;

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•to position the electrodes close to the eyes; make sure that the current
delivered does not cross the eyeball (one electrode diametrically
opposite to the other in relation to the eye); keep a distance of at least 3
cm from the eyeball;
•to use electrodes if they no longer stick to the skin. Repeated use of the
same electrodes can compromise the safety of the stimulation, in fact it
can cause skin redness that can last for many hours after the
stimulation.
Warning:
•insufficiently sized electrode sections can cause skin reactions or burns;
•do not use damaged electrodes even if they well adhere to the skin;
•use only cables and electrodes supplied by the manufacturer.
The manufacturer considers himself responsible for the performances,
reliability, safety and security of the device only if:
•any addition, modification and/or repair are carried out by authorized
personnel;
•the environmental electrical installation to which T-ONE COACH is
connected is compliant to the national laws;
•the instructions for use contained in this manual are strictly followed.
Device use
T-ONE COACH is a portable generator of TENS and NEMS currents with
battery, specially designed for daily use in the treatments of the most
common forms of muscular pains. T-ONE COACH has 4 independent outputs
that can be adjusted by the user. The device also comes with a 2+2 feature
(multi patient feature), that allows treating up to two patients by setting two
different programs (chosen from a list of 10 programs) on channels 1-2 and 3-
4.
Main menu and single/multi patient selection
Start the device from key , open the menu and use the selection keys
and to choose between SINGLE PATIENT, MULTI PATIENT AND LAST 10
PROGRAMS modes.

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In the INDIVIDUAL PATIENT mode, the active program is set an all 4 output
channels.
In the MULTI PATIENT mode, you can set two different programs (chosen
from the list of 10 programs) on the 4 channels: channels 1 and 2 will operate
on a program and channels 3 and 4 on the other program.
This function is particularly useful when you have to treat two patients in the
same session but also when you need to use two different programs on a
single patient, on two different areas of his body or for two different
disorders.
The function LAST 10 PROGRAMS allows you to quickly find the list of the last
10 programs used.
Confirm the selection by pressing .
Preliminary settings
CONNECTING THE CABLES AND THE ELECTRODES
Place electrodes near the area to be treated (see next paragraph), connect
the electrodes to the connection cables and then connect the cables to the
outputs located on the bottom of T-ONE COACH.
Single patient pre-set programs
To use the T-ONE COACH pre-set programs, follow the instructions below.
1. SELECTING THE PROGRAM MODE
After choosing the SINGLE PATIENT mode, you must proceed to the
selection of the desired program, from the 3 groups of programs:
TENS, NEMS, BEAUTY. Switch between groups using the selection
keys and , and then select the desired program using the
selection keys and ; confirm the selection by pressing .
2. INTENSITY ADJUSTMENT
Use the coloured CH1/CH2/CH3/CH4 up arrow keys to increase the
current intensity on the 4 channels. The value changes by 1mA

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increments. To decrease the intensity, use the coloured
CH1/CH2/CH3/CH4 down arrow keys.
T-ONE COACH can detect the connection of the electrodes: if incorrectly
connected, it resets the intensity value once it reaches 10mA. On the display
will appear setting similar to the ones below:
The settings displayed vary based on the program selected by you; you can
also change the stimulation intensity for the selected program.
For programs consisting of a single phase, the device's screen will be similar
to the one below, showing the overall treatment time and the intensity set on
each channel:
For programs consisting of multiple phases (from 2 to 4, typically NEMS and
BEAUTY programs but also some of the TENS programs) the device's screen
will be similar to the one below, showing the work phase (PHASE) in the lower
left corner:
Some programs allow you to select the muscular area to be treated (upper
limbs, trunk, lower limbs) and they also come with special MALE/ FEMALE
modes. After choosing the program, the display will show a screen similar to
the following:

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Use the selection keys and to choose the MALE/FEMALE mode and
then use the selection keys and to select the desired treatment area
(highlighted in yellow for males and in magenta for females). Confirm your
selection by pressing ; on the display will appear the main screen of the
selected program.
Some programs (TENS, NEMS and BEAUTY) also provide different wave
characteristics for contraction and recovery, and therefore, you need to set a
different current intensity for the two stimulations. This setting is indicated by
the icon in the lower right corner of the screen, as shown below:
Icon represents a contraction, while icon represents a
recovery.
See the following chapters for more details on program features,
specifications and settings available.

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Tips on how to adjust the intensity
TENS (Transcutaneous Electrical Nerve Stimulation): the intensity should be
adjusted between the threshold of perception and the threshold of pain. The
maximum limit is represented by the moment when the muscles surrounding
the treated area begin to contract. We recommend that you stay under that
limit.
The electrodes must be placed in a square formation around the painful area,
using channel 1 and channel 2 (or channels 3 and 4) as shown in photo 1.
NEMS (Neuro Electrical Muscle Stimulation): in the actual work phase, the
programs alternate 5/7 seconds of contraction (when the muscle is visibly
contracted) with 7/20 seconds of recovery (when the muscle is relaxed or
subject slightly stimulated). The intensity during the contraction can be
compared with the workload to which the muscle is subjected. Usually, the
greater the stimulation intensity is, the greater the training load will be. This
is true, however, until the maximum contraction limit of the muscle is
reached; any increase in intensity beyond this level in unnecessary as it does
not improve the training.
Important tip: to reduce the sense of discomfort and reach higher intensities,
we recommend that you produce a voluntary contraction between the
contraction generated by T-ONE. This voluntary contraction shall be carried
out with the limb locked (technically in isometry), in other words, without
moving the limb.
BEAUTY: the indications are similar to those given for NEMS programs.
IMPORTANT
Apply the electrodes in a square formation
above the painful area, keeping a
minimum distance of 4 cm between one
electrode and the other.
Figure 1 – Electrodes’
positioning.

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List and characteristics of the programs available in single
patient mode
TENS Programs
Prg
Progr.
medicale
Sì/No
Descrizione FASE 1 FASE 2 FASE 3
T1 Yes TENS rapid
Total time 40min
Frequency 90Hz
Pulse width 50µ
T2 Yes TENS Endorphinic
Total time 30min
Frequency 1Hz
Pulse width 200µs
T3 Yes TENS maximum
values
Total time 3min
Frequency 150Hz
Pulse width 200
µ
s
T4 Yes Anti-
inflammatory
Total time 30min
Frequency 120Hz
Pulse width 40
µ
s
T5 Yes Neck pain
Total time 30min
Frequency 90Hz
Pulse width 60µs
Total time
10min
Frequency
2Hz
Pulse
width
150
µ
s
T6 Yes Backache/Sciatica
Total time30min
Frequency 90Hz
Pulse width 60µs
Total time
10min
Frequency
2Hz
Pulse
width
150
µ
s
T7 Yes Sprains / Bruises
Total time 30min
(6s 100Hz–175µs
+ 6s 2-100Hz
modulated–250µs
+ 6s 150Hz–60-
200µs modulated)
T8 Yes Vascularisation
Total time 20min
Frequency 2Hz
Pulse width 200µs

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Prg
Progr.
medicale
Sì/No
Descrizione FASE 1 FASE 2 FASE 3
T9 Yes Muscle relaxant
Total time 10min
Frequency 2Hz
Adjustable pulse
width
Total time
10min
Frequency
6Hz
Total time
10min
Frequency
4Hz
T10 Yes Hand/wrist pain
Total time 30min
(6s 100Hz–175µs
+ 6s 2/100Hz
modulated–250µs
+ 6s 150Hz–60/
200µs modulated)
T11 Yes Plantar
stimulation
Total time 30min
(6s 100Hz–175µs
+ 6s 2-100Hz
modulated–250µs
+ 6s 150Hz–60/
200µs modulated)
T12 Yes Epicondylitis
Total time 30min
(6s 100Hz–175µs
+ 6s 2-100Hz
modulated–250µs
+ 6s 150Hz–60/
200µs modulated)
T13 Yes Epitroclea
Total time 30min
(6s 100Hz –175µs
+ 6s 2-100Hz
modulated–250µs
+ 6s 150Hz –60/
200µs modulated)
T14 Yes Periarthritis
Total time 30min
Frequency 90Hz
Pulse width 50µs
Total time
10min (7s
3Hz–
200µs + 3s
1Hz–
200µs + 5s
30Hz–
200µs)
T15 Yes Tens Burst
Total time 30min
Frequency 2Hz
Pulse width 80µs
Burst impulses

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Prg
Progr.
medicale
Sì/No
Descrizione FASE 1 FASE 2 FASE 3
T16 Yes Micro-current
Total time 30min
Frequency 90Hz
Pulse width 20µs
The indications of the electrodes’ positioning are available in the Positions
manual.
TENS 1 • TENS rapid (medical program)
Program also called conventional TENS, used for analgesic purposes; its
purpose is to induce the organism into blocking pain at the spine, in
accordance with the “Gate Control Theory” by Melzack and Wall. Pain
impulses leave part of the body (for example the hand) and run along the
nerve tracts (through small-diameter nerve fibres) until they reach the central
nervous system where the impulses are interpreted as pain. Conventional
TENS activates large-diameter nerve fibres, blocking the path of small-
diameter nerve fibres at the spine. Therefore, this action is mainly taken
against the symptom: to simplify it further, the wire transmitting pain
information is obstructed.
The rapid/conventional Tens is a current that can be used in the treatment of
daily pains in general, joint, muscular and tendon pains, arthrosis, arthritis,
etc. The first benefits can be seen after 10/15 treatments carried out on a
daily basis (no contraindications id the dose is doubled). The program can be
repeated at the end of the session if the patient experiences particularly
persistent pain. Due to the nature of the pulse, the patient might experience
an “addiction” effect due to which the pulse will be felt less and less: to
counteract this effect, you can increase the intensity by one level if necessary.
Session duration: 40 minutes (no less than 30/40 minutes), in a single phase.
Electrodes’ positioning:form a square above the painful area as shown in
Figure1.
Intensity: to be adjusted in order to have a good solicitation of the stimulated
part, but not over the pain threshold.
TENS 2 • TENS Endorphinic (medical program)
This type of stimulation produces two types of effects according to how the
electrodes are
positioned: positioning the electrodes in the dorsal region, see photo 10 in
the Positions Manual, promotes the endogenous production of morphine-like
substances capable of raising the pain perception threshold; positioning the

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electrodes to form a square over the painful area, as shown in Figure 1,
produces a vascularising effect. Vascularisation increases arterial flow,
enhancing the removal of algogenic substances and facilitating the
restoration of normal physiological conditions.
Session duration: 30 minutes in a single phase, on a daily basis.
Electrodes’ positioning: photo 08 of Positions manual or on the treated area
as shown in Figure 1, do not place the electrodes near areas prone to
inflammation.
Intensity: adjusted so as to ensure good solicitation of the part stimulated,
the sensation must be similar to that of a massage.
TENS 3 • TENS maximum values (medical program)
This program blocks pain impulses peripherally creating a proper
anaesthetizing effect in the treated area. This type of stimulation is suitable
for injuries or bruises when rapid action is required. That is the reason why
such stimulation is undoubtedly the least tolerated, but it is extremely
effective. This type of stimulation is not recommended for particularly
sensitive people and in any case the electrodes should not be positioned in
sensitive areas such as the face and genitals or close to wounds.
Session duration: very short, 3 minutes in a single phase.
Electrodes’ positioning: form a square above the painful area as shown in
Figure1.
Intensity: it is the maximum tolerable value (well in excess of conventional
TENS, and therefore with considerable contraction of the muscles
surrounding the area treated).
TENS 4 • Anti-inflammatoty (medical program)
Program recommended for inflammatory conditions. To be applied until the
inflammatory state is lessened (10-15 applications, once a day; the daily
treatments can be doubled if required).
Session duration: 30 minutes.
Electrodes’ positioning: identified the area to be treated, position the
electrodes as shown in Figure 1.
Intensity: to be adjusted until a tingling feeling is produced in the area
treated; avoid contracting the surrounding muscles.
TENS 5 • Neck pain (medical program)
Special program for neck pain relief. The first benefits can be seen after 10 to
15 treatments carried out on a daily basis; continue the treatment until the
symptoms disappear.
Session duration: 40 minutes.