FISIOTECH FISIOTEK LT User manual

Rev.04 01/2018
FISIOTECH SRL
Operating headquarters
:
Via Toniolo, 44/E-F - 31028 Vazzola (TV) - ITALY
Registered office
:
Via Valdoni, 19 - 31013 Cimavilla di Codo nè (TV) - ITALY
Tel. [phone] - Fax [phone] - mail : [e-mail] - pec : [email protected]
VAT number IT 03765100262 - Rea TV 296956
USE AND MAINTENANCE MANUAL
FISIOTEK LT
FISIOTEK LT MODELS
Description
Code
Fisiotek LT 134060

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TABLE OF CONTENTS
1. GENERAL INFORMATION
.......................page 3
1.1 Manufacturer
1.2 Certification and EC Marking
1.3 Warranty
1.4 Structure of the Manual
1.4.1 Purpose and Contents
1.4.2 Addressees
1.4.3 Preservation
5. MAINTENANCE
.......................................page 29
5.1 Safety Warnings
5.2 Routine Maintenance
5.3 Cleaning
5.4 Troubleshooting
5.5 Extraordinary Maintenance
5.5.1 Replacing Protection Disk
5.5.2 Replacing Reversal Microswitch
5.5.3 Replacing Safety Microswitch
5.5.4 Replacing Toothed Belt
5.5.5. Replacing Motor
5.5.6 Replacing Gear Motor
5.5.7 Replacing Electronic Card
5.6 Request for Assistance.......................
2. DESCRIPTION
..........................................page 4
2.1 Description of the Instrument
2.2 Environmental Conditions
2.3 Technical Specifications
2.4 Symbols Used
2.5 Electromagnetic Environment
2.6 Disposal
6. ELECTRICAL SAFETY TESTS
..............page 34
6.1 Description of Tests
6.2 Frequency of Tests
3. SAFETY
....................................................page 8
3.1 General Warnings
3.2 Foreseen Use
3.3 Contraindications of Use
3.4 Operator profile
3.5 Training
3.6 Stop Functions
3.7 Special Warnings
7. SPARE PARTS
........................................page 34
7.1 Ordering Spare Parts
7.2 Identification of Spare Parts
4. ARRANGEMENT
....................................page 10
4.1 Start-up
4.2 Possible Movements
4.2.1 Elevation in Flexion for Seated Patients
4.2.2 Elevation in Flexion for Supine Patients
4.2.3 Elevation in abduction
4.2.4 Internal-External Rotation for Seated Patients
4.2.5 Internal-External Rotation for Seated Patients
1. GENERAL INFORMATION

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1.1 MANUFACTURER
RIMEC s.r.l.
Loc. Braine 57/a
40036 Rioveggio (BOLOGNA) ITALY
DISTRIBUTOR
FISIOTECH SRL
Sede Operativa: Via Toniolo, 44/E-F
31028 VAZZOLA (TV) - Italia
Tel. [phone]
Fax [phone]
[email protected]
1.2 EC CERTIFICATION AND CE MARKING
Fisiotek LT carries the CE Marking as it was produced in compliance with EU Directive 93/42 concerning
medical devices, as amended by 2007/47/EEC.
1.3 WARRANTY
The duration of the Warranty is laid down by EC Directive 99/44 and, therefore, by its transposition on behalf
of the EU Member States. Not included: damage caused by transport and/or handling, faults and/or
breakage due to machine misuse.
1.4 STRUCTURE OF THE MANUAL
The Customer should read all the information contained in this Manual carefully, since it is an integral part of
the equipment from a Functional and Safety point of view.
1.4.1 SCOPE AND CONTENT
This Manual is intended to provide the Customer with all the necessary information to use the
machine adequately but also to be able to manage it autonomously and safely. This manual contains
information on Technical aspects, Operation, Maintenance, Spare parts and Safety.
Before carrying out any type of work on the machine, the Operators and Qualified
Technicians should carefully read the instructions provided in this Manual. If you are not sure
to have correctly understood these instructions, please contact the Manufacturer to get the
necessary clarifications.
1.4.2 RECIPIENTS
This Manual is both for the Operator and the Technicians authorized to carry out maintenance in the
machine. Operators must not perform tasks reserved to Qualified Technicians (see
Maintenance chapter). The manufacturer is not liable for any damage resulting from failure to comply
with this prohibition.
1.4.3 PRESERVATION
This Instruction Manual should always go with the Machine and must be kept away from anything
that may compromise its readability.

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Fig. 2/B
Fig. 2
Fig. 1
2. DESCRIPTION
2.1 DESCRIPTION OF THE INSTRUMENT
Fisiotek LT is an instrument that allows for passive rehabilitation of the shoulder through different types of
movement. It is made up of a base frame on swiveling wheels with brake. This allows the instrument to be
easily moved and blocked in the desired position. The height is adjustable.
The Switch (1) switches the device on and is also used to select Battery (B) or Power supply (30) function;
whereas Potentiometer (2) allows the operator to modify the speed ranging from 2°/sec to 4,5°/sec.
Cursors (3) determine the width of the movement. The Start and Stop keys are located on Keyboard (4).
Accessories (A1) for elevation-in-flexion and elevation-in-abduction movements and (A2) for performing
internal and external rotation movements can be mounted on Clamp (6).

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2.2 ENVIRONMENTAL CONDITIONS
The instrument does not require specific environmental conditions. It must be used indoors. Admitted
temperatures range from 5°C to 40°C, with humidity from 30% to 75% and pressure from 700 to 1060 hPa.
Storage temperature ranges from -5°C to 50°C.
2.3 TECHNICAL SPECIFICATIONS
•The device and accessories have a 5-year lifetime
•Device for continuous use
•Electrical safety: Class II B instrument, EN 60601-1 Standard Power supply: 12 V - 50/60 Hz -
4.8 W
•Fuse: 1 AT; located on the electronic card, see Fig. 25, section “Maintenance”
•Protection rating: IP20 (prevent the device from getting wet)
•Weight: 35 kg
Power supply unit:
•Electrical safety: Class II, EN 60601-1 Standard
•Input: 100 - 240 V - 50/60Hz - 600 mA
•Output: 12 V - 2.08 A
•Protection rating: IP41
Battery: Ni - Cd 10 cells; 12V; 1.3Ah
2.4 SYMBOLS USED
2.5 ELECTROMAGNETIC ENVIRONMENT
•Fisiotek must be put into service in accordance with the information concerning the Electromagnetic
Compatibility contained in this manual.
•Portable radio communication instruments may affect Fisiotek operation.
•Fisiotek passed the electromagnetic compatibility tests using the following cables:
- power supply cable, length 2 m;
- mobile keyboard cable, length 1.5 m.
If cables other than those mentioned above are used, an increase in emissions or a decrease in instrument
immunity may occur.
2.6 DISPOSAL
The equipment must be disposed of separately, offenders will be fined in compliance with local rules. To get
information about the ways of collection, please contact the local distributor.

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3. SAFETY
3.1 GENERAL WARNINGS
The Operator must carefully read the information given in this manual, particularly the safety precautions
described in this section.
The equipment adjustment parameters must be set by medical experts in the passive rehabilitation field.
3.2 FORESEEN USE
The device has been designed and built to perform passive rehabilitation of the right and left shoulders. This
is achieved by making the patient’s limb, which is positioned on the device, perform different types of
movement, as clearly described in the User’s Manual.
3.3 CONTRAINDICATIONS OF USE
The device must not be used:
•for any purposes other than those indicated in paragraph 3.2
•in explosive atmospheres
•in a fire risk environment
•in places exposed to the elements
•with electrical and/or mechanical jumpers that cut off parts of the device
•connected with an electric power supply system that does not comply with the related regulations in
force
3.4 OPERATOR PROFILE
The values of the various programmable functions that determine the amplitude of the movement, the speed
etc., must be decided by qualified personnel (orthopaedic doctor, physiatrist, physiotherapist) taking account
of the patient’s pathology.
The patient, or a third person, can be the operator if the device is already programmed as described above.
They should have the following minimum requirements:
•Educational level: not relevant.
•Basic knowledge: open minded reading skills, knowledge of linear and angular measuring systems,
able to use a simple keyboard and follow simple instructions.
•Knowledge of foreign languages: irrelevant.
•Experience: irrelevant.
• Physical conditions: (if the patient is the operator) sufficient mobility to be able to position oneself on
the device is required.
3.5 TRAINING
No operator training is envisaged.
3.6 STOP FUNCTIONS
The stop functions of the device are the following:
•Main switch (1)

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3.7 SPECIAL WARNINGS
•Periodically check the state of the locking and adjusting levers of accessories A1 and A2 (fig. 2).
•Periodically check the state of the clamp 6 blocking knob (fig. 1).
•Periodically check that spring pivot 20 is working properly (fig. 9).
•Make sure that when the spring pivot located on cursors 3 (fig. 1) moves, a beeping sound can be
heard, thus ensuring that the safety microswitch is working correctly. If no sound is heard, contact
technical support.
•The wheels with brake must be carefully checked each time they are subject to anomalous stress
(violent shock).
•Before starting the movement, the operator must brake the wheels and make sure that all
adjustment locking knobs are suitably tightened.
•The device power supply unit must be periodically tested in order to ensure the safety features
against electrical risks. See section “Electrical safety tests”
•The physiotherapist must train the patient with regard to use of the mobile keyboard.
•If the patient is unable to manage himself on his own during the rehabilitation session, he must be
assisted.
•The power supply unit cable presents a potential risk of strangling, just as the unscrewed knobs
separated from the device could be swallowed, causing suffocation. It is therefore necessary to take
adequate precautions in the presence of children and animals.
•Open wounds must be adequately protected so they do not come into direct contact with the device.
•Use parts and accessories supplied by the manufacturer only.
•Do not introduce changes to the device since they could cause the device to become unsafe to use.
•The battery supports approximately 1000 discharge cycles
•Keep the device well away from other devices that might be a source of disturbance.
•If the device is used by two or more patients, the parts that come into contact with the patient must
be cleaned and disinfected.
• When not in use, it is recommended to keep the device protected from dust and out of direct contact
with sources of heat and sunlight.

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Fig. 4/B
Fig. 4
4. ARRANGEMENT
4.1 START-UP
•Connect mobile keyboard (4) to the instrument.
•Connect power supply unit (30) to both the instrument and the mains. Warning! Make sure that the
line current matches the technical specifications of the machine.
• Move the switch (1) to position .
Using the Battery
•Insert the battery as shown in the illustration and press down into the
correct position.
•Move the switch (1) to position .
When new, the battery will work for about 2 hours; after this movement will be
interrupted and an intermittent beep will be heard.
Replacing the Battery
•Move the switch (1) to the middle position “ 0 ” .
•Press the two elastic tabs at the side simultaneously to release the
battery, then remove.

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Advice on using and recharging the battery
•The battery charger has its own specific instruction sheet and is not considered a part of the Fisiotek
LT
•When using the battery, the following indications must be observed:
- do not expose to heat, flames, radiation from the sun or temperatures above 50°C
- do not throw into fire or water (risk of explosion)
- do not discard run-down batteries in the environment; use the special containers designed for their
disposal or take to a waste collection centre
- only use the battery charger supplied along with the device for recharging the battery and follow the
instructions carefully
4.2 POSSIBLE MOVEMENTS
•elevation in flexion ranging from 0°to 180°for seated patients
•elevation in flexion ranging from 0°to 180°for supine patients
•elevation in abduction - complete physiological range - for seated patients
•internal and external rotation – 90°0°90°- for seated and supine patients.
4.2.1 ELEVATION IN FLEXION FOR SEATED PATIENTS

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Fig. 6
Fig. 7
Arranging the instrument according to the shoulder to be rehabilitated
For this type of movement, accessory (A1) is used. It must be arranged according to the right or left
shoulder to be mobilized, as shown in Fig. 6. Supports (7) and (8) must be completely removed, turned 180°
and inserted back on the same tubing. The accessory is then to be inserted in Fisiotek LT’s clamp in the
direction shown by the arrow.
Arrangement for right shoulder
Arrangement for right shoulder
For this type of movement, the patient must keep his limb straight, then the two segments of
accessory (A1) must both be straight to one another. This position can be achieved using lever (9).
The accessory must now be mounted on the instrument. Insert accessory (A1) on the side of the clamp
marked by the R or L adhesive label according to the shoulder to be mobilized. Make sure that the accessory
is fully inserted in clamp (10) and tighten knob (11). See Fig. 7.

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Fig. 8
Setting the width of the movement
Cursors (3) determine the two limits of the angular movement of the mechanical arm.
They can slide along the edge of disk (14) and are locked on it by spring pivots (15). An index (16) is located
on the cursors to allow the operator to determine the point selected on graduated scales (17). See Fig. 8.
If the left shoulder must be mobilized by means of an elevation-in-flexion movement having a width ranging
from 30°to 90°:
•select the graduated scale marked by "Elevation LEFT seated patient";
•by lifting spring pivot (15), move one cursor (3) having the “-Lower LEFT Elevation” adhesive label to
the 30°position and the other cursor (3) having the “-Upper LEFT Elevation” adhesive label to 90°.
NOTE: If during cursor positioning mechanical arm (18) is an obstacle, it must be moved to a position
ranging from 30°to 90°using the Start and Stop keys on the keyboard.

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Fig. 9
Fig. 10
Positioning the patient’s limb on the instrument
•Have the patient sit correctly on a chair with no armrests and with a narrow backrest.
•Measure the distance of the seated patient’s shoulder from the ground using a rule.
•Adjust the height of the instrument according to the measurement taken. Loosen knob (19), lift spring
pivot (20) and slide bush (21) until its upper part matches the desired value on graduated scale (22),
then tighten knob (19).
NOTE: Before tightening knob (19) make sure that spring pivot (20) is inside one of the holes of
upright (23).
•By using the Start and Stop keys on the keyboard, move the mechanical arm to the lower limit of the
selected movement.
•Move the instrument close to the patient, position the patient’s limb on the instrument by resting it on
shaped plastic supports (25) and (26). The shoulder must match the centre of clamp (24). Support
(25) must be positioned approximately at the middle of the arm and support (26), which supports the
forearm, must be in a comfortable position for the patient.
•Lock the machine to the ground using the wheel brakes.
•Press START to start movement.
•Warning! Do not forget to give the patient the keyboard and train him how to use it.

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Fig. 11
4.2.2 ELEVATION IN FLEXION FOR SUPINE PATIENTS

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Fig. 6
Fig. 7
Arranging the instrument according to the shoulder to be rehabilitated
For this type of movement accessory (A1) is used. It must be arranged according to the right or left shoulder
to be mobilized, as shown in Fig. 6. Supports (7) and (8) must be completely removed, turned 180° and
inserted back on the same tubing. The accessory is then to be inserted in Fisiotek LT’s clamp in the direction
shown by the arrow.
Arrangement for right shoulder
Arrangement for left shoulder
For this type of movement, the patient must keep his limb straight, then the two segments of accessory (A1)
must both be straight to one another. This position can be achieved using on lever (9) . The accessory must
now be mounted on the instrument. Insert accessory (A1) on the side of the clamp marked by the R or L
adhesive label according to the shoulder to be mobilized. Make sure that the accessory is fully inserted in
clamp (10) and tighten knob (11). See Fig. 7.

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Fig. 8
Setting the width of the movement
Cursors (3) determine the two limits of the angular movement of the mechanical arm. They can slide along
the edge of disk (14) and are locked on it by spring pivots (15). An index (16) is located on the cursors to
allow the operator to determine the point selected on graduated scales (17). See Fig. 8.
If the left shoulder must be mobilized by means of an elevation-in-flexion movement having a width ranging
from 30°to 90°:
- select the graduated scale marked by "Elevation LEFT supine patient";
- by lifting spring pivot (15), position one cursor (3) having the “-Lower LEFT Elevation” adhesive label
to 30°and the other cursor (3) having the “-Upper LEFT Elevation” adhesive label to 90°.
NOTE: If during cursor positioning mechanical arm (18) is an obstacle, it must be moved to a position
ranging from 30°to 90°using the Start and Stop keys on the keyboard.

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Fig. 9
Fig. 12
Positioning the patient’s limb on the instrument
•Measure the distance of the supine patient’s shoulder from the ground using a rule.
•Adjust the height of the instrument according to the measurement taken. Loosen knob (19), lift spring
pivot (20) and slide bush (21) until its upper part matches the desired value on graduated scale (22),
then tighten knob (19).
NOTE: Before tightening knob (19) make sure that spring pivot (20) is inside one of the holes of
upright (23).
•By using the Start and Stop keys on the keyboard, move the mechanical arm to the lower limit of the
selected movement.
•Move the instrument close to the patient, position the patient’s limb on the instrument by resting it on
shaped plastic supports (25) and (26). The shoulder must match the centre of clamp (24), support
(25) must be positioned approximately at the middle of the arm and support (26), which supports the
forearm, must be in a comfortable position for the patient.
•Lock the machine to the ground using the wheel brakes.
•Press START to start movement.
•Warning! Do not forget to give the patient the keyboard and train him how to use it.

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Fig. 13
4.2.3 ELEVATION IN ABDUCTION

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Fig. 6
Fig. 7
Arranging the instrument according to the shoulder to be rehabilitated
For this type of movement, accessory (A1) is used. It must be arranged according to the right or left
shoulder to be mobilized, as shown in Fig. 6. Supports (7) and (8) must be completely removed, turned 180°
and inserted back on the same tubing. The accessory is then to be inserted in Fisiotek LT’s clamp in the
direction shown by the arrow.
Arrangement for right shoulder
Arrangement for left shoulder
For this type of movement, the patient may keep his limb either straight or bent. To achieve the desired
position, lever (9) must be used. This operation can be performed also after the limb has been positioned.
The accessory must now be mounted on the instrument. Insert accessory (A1) on the side of the clamp
marked by the R or L adhesive label according to the shoulder to be mobilized. Make sure that the accessory
is fully inserted in clamp (10) and tighten knob (11). See Fig. 7.