I-Tech I-Press User manual

USER MANUAL
Pressotherapy

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Table of contents
TABLE OF CONTENTS I
TECHNICAL INFORMATION 3
MANUFACTURER 3
DECLARATION OF CONFORMITY 3
CLASSIFICATIONS 4
INTENDED PURPOSE AND SCOPE OF USE 4
TECHNICAL SPECIFICATIONS 5
DEVICE DESCRIPTION AND CONTROLS 6
LABELLING 7
Pack contents 9
HOW TO USE THE DEVICE 10
INTRODUCTION TO THE TECHNOLOGY 10
CONTRAINDICATIONS 10
WARNINGS 11
PATIENT PREPARATION 12
USE OF DEVICE 14
RECOMMENDED THERAPY SETTINGS 16
LOOKING AFTER FOR THE DEVICE 17
MAINTENANCE 17
TROUBLESHOOTING 18
DISPOSAL INFORMATION 19
WARRANTY 20
Support 21
Spare parts 21
INTERFERENCE AND ELECTROMAGNETIC COMPATIBILITY TABLES 22

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IACER Srl 3 MNPG338-00
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 (CE certificate No.
HD60134521 issued by the Notified Body No. 1936 TÜV Rheinland Italia srl).
Declaration of conformity
I.A.C.E.R. S.r.l
Via S.Pertini 24/A – 30030 Martellago (Ve), Italy
declares under its own responsibility that the product
I-PRESS
UMDNS code: 10969
is designed and built in compliance with the essential requirements of
Annex 1 of Directive 93/42/EEC concerning medical devices
(implemented in Italy with Legislative Decree 46/97), as amended by
Directive 2007/47/EC (Legislative Decree 37/2010) and subsequent
amendments/additions.
The device is classified class IIa, according to Annex IX, rule 9 of Directive
93/42/EEC (and subsequent amendments/additions) and is marked
The conformity of the product in question with the Directive 93/42/EEC
has been verified and certified by the Notified Body:
1936 - TÜV Rheinland Italy
Via Enrico Mattei 3, 20010 Polignano Milanese (MI), Italy
Certificate No.: HD60134521
according to the certification process provided for in Directive
93/42/EEC, Annex II (excluding point 4).
________________ _____________________
Place, date Legal representative
MASSIMO MARCON
Martellago, 31/07/2020

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Classifications
The I-PRESS device assumes the following classifications:
•class IIa device (Directive 93/42/EEC, annex IX, rule 9 and subsequent
amendments/additions);
•Class II with type BF applied part (Classif. EN 60601-1);
•IP21 protection degree device in relation to the penetration of liquids
and dust.
•device and applicators not subject to sterilisation;
•device not suitable for use in the presence of a flammable anaesthetic
mixture with air or with oxygen or with nitrous oxide;
•device intended for continuous operation;
•device not suitable for external use.
Intended purpose and scope of use
Clinical purpose: Therapeutic
Scope of use: OutpatientClinic/Hospital and home
The I-PRESS device for pressotherapy is ideal for the treatment of diseases
affecting the circulatory system, in order to improve peripheral blood
circulation. This type of device is designed for the following applications:
-Oedema
-Lymphedema
-Venous ulcers
-Venous insufficiency
-Muscle recovery
The device can be used by patients themselves. In this case they will also
assume the role of operator during therapy.
The minimum age for patients to use the device is 18 years.

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Technical specifications
Feature
Specification
Power supply
Mains power supply 230V AC, 50Hz
Fuses
T1A x1
Total consumption
100mA max
Insulation (EN 60601-1)
II
Applied parts (EN 60601-1)
BF
Dimensions
(Length x Width x Height)
260 x 200 x 125 mm
Weight
2 kg
IP protection
IP21
Pressure
200 mmHg (±20%)
Treatment duration
0 ÷ 30 minutes
Operation
Continuous
Conditions of use
Ambient
temperature
From +5 to +40°C
Relative humidity
From 15 to 93%
Atmospheric
pressure
700-1060 hPa
Storage/transport conditions
Ambient
temperature
From +5 to +40°C
Relative humidity
From 15 to 93%
Atmospheric
pressure
700-1060 hPa
Useful life of the device: 3 years.

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Device description and controls
No. Feature Description
1 Timer Time setting knob
2 Pressure Pressure setting knob
1
2

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Labelling
Symbol
Meaning
Manufacturer's logo.
Product certification issued by notified body No. 1936.
Device with type BF applied part according to EN 60601-
1 ed. III.

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Symbol
Meaning
Class II device
Manufacturer data.
Date of manufacture (YYYY-MM).
Consult the user manual.
WEEE directive for the disposal of electronic and
electrical waste.
Serial number
IP21
Degree of protection against entry of solids, dusts and
liquids (device protected against solid foreign bodies
with a
diameter of ≥12.5mm and against the vertical fall
of water drops).
IP21
Caution, danger.
Allowed temperatures (storage temperatures, on
packaging)
Relative humidity (storage relative humidity, on
packaging)

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Pack contents
The I-PRESS pack in all configurations contains:
-1 I-PRESS device with applicators;
-1 user manual
-Non-woven fabric strip 15x150 cm (see page 13 for further details)
The pack is supplied in 3 different versions depending on the type and also
contains:
LEG2 - right leg cuff, left leg cuff, 4-chamber 8-ending tube, two pressure
orthotics.
LEG1 - leg cuff (right or left), 4-chamber 4-ending tube, one pressure orthotic.
ARM1 - arm cuff (right or left), 4-chamber 4-ending tube.
All these configurations are available in M or L options (for example LEG1 M or
LEG1 L).
Also available as optional items are the leg cuff extensions for wide legs.
N.B.: it is recommended to interpose the non-woven fabric band between the
foot and the orthotic.

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How to use the device
Introduction to the technology
Pressotherapy is a useful method for treating diseases and conditions affecting
the circulatory system, as it is able to promote correct venous circulation,
reducing muscle tension caused by stress or chronic and acute pain. Thanks to
its pump action, it actually promotes venous return (see figure below),
increasing the blood supply of the tissues and their consequent correct
physiological renewal.
Pressotherapy is therefore able to solve the
problem of blood that could stagnate in
damaged blood vessels or in any case in
areas of the body that are not properly
supplied.
External compression also allows excess
interstitial fluids to return more easily to the
circulatory system, so that they can be
properly and quickly eliminated.
Contraindications
Undesirable effects may occur if the device is used in the following situations
or in people suffering from the following diseases and conditions:
•people with implantable medical devices;
•people suffering from pulmonary oedema, heart attack,
phlebocarcinoma, high blood pressure, high fever;
•people suffering from burns, dermatitis, purulent wounds, malignant
tumours, etc .;
•people who have undergone skin surgery in the treatment area;
•people with severe circulation problems, such as hardening of the
arteries, angina, heart attack, etc .;
•people with suspected blood clots;
•people with severe malformations or wearers of prostheses (or other
fixation devices) in the treatment area;
•immediately after undergoing surgery for the treatment of varicose
veins;

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•patients who have just undergone surgery, pregnant women,
children;
CONSULT YOUR DOCTOR BEFORE STARTING TREATMENT WITH THE DEVICE.
Warnings
It is recommended:
•to use the device keeping the applicator at least 3 metres away from
televisions, monitors, mobile phones or any other electronic equipment
even if the device does not generate or receive any electromagnetic
interference from other equipment;
•to avoid use of the device by people who are not properly trained and
who have not read this manual;
•during therapy, the user is advised not to wear metal objects;
•to pay attention to the use of connection cables in the presence of
children/young people: potential strangulation hazard. Keep out of the
reach of children;
•position the device so that the mains plug can be easily disconnected;
•use ONLY applicators supplied by the manufacturer.
It is forbidden:
•for the device to be used by people of unsound mind, who suffer from
sensitivity disorders, or temporarily unfit if not assisted by qualified
personnel; children under the age of 12 or in any case those not
adequately trained in the use of the device by an adult;
•to use the device if you find any damage or signs of deterioration to it or
to the applicators and/or cables: contact the retailer or the manufacturer
as indicated in the Support paragraph. Check the condition of the device
before each use;
•to use the device near flammable substances, gases, explosives, in
environments with high oxygen concentrations, in the presence of
aerosols or in very humid environments (do not use in the bathroom or
while showering/bathing);
•to use the device while driving vehicles or while operating and controlling
equipment/machinery;
•to use sharp objects on the device.

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Warning:
•it is forbidden to use the device in combination with other devices that
monitor/support vital functions.
•do not crush, bend or damage the electric cable. Electrical shock hazard.
•do not immerse the device in liquids.
•be careful when closing the zip to avoid entangling hair or clothing.
•avoid knocking or dropping the device.
•do not move when you are using the device.
The manufacturer is to be considered responsible for the safety, reliability
and performance of the device provided that:
•any additions, modifications and/or repairs are carried out by
authorised personnel;
•the electrical system of the environment in which I-PRESS is inserted
complies with national laws;
•the devices is used in strict compliance with the instructions reported in
this manual.
If foreign substances get into the device, contact the retailer or manufacturer
immediately. Should the device fall, check that there are no cracks in the
container or damage of any kind; if there are, contact your dealer or
manufacturer.
In the event of any change in performance during treatment, stop treatment
immediately and contact your dealer or manufacturer immediately.
Patient preparation
1. Select the appropriate applicator for the area being treated.
1.1. Leg cuffs

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1.1.1. Attach the connector relating to the tube with 8 endings (for
using two leg cuffs) or the connector relating to the tube with 4
endings if using a single leg cuff;
1.1.2. Put on the leg cuffs (or the single leg cuff) and close the zip up
to the top, then close the Velcro fastener; if it is necessary to
increase the circumference of the leg cuffs, add the extenders
for leg cuffs available on request;
1.1.3. Insert the pressure orthotics at the lower ends of the leg cuffs,
under the sole of the foot.
N.B.: it is recommended to cut the non-woven fabric band
according to the shape of the pressure orthotics and place it
between the foot and the pressure orthotics.
1.1.4. When wearing the leg cuffs make sure that the connection
inlets of the tubes is always on the inside of each leg cuff; if only
one leg cuff is used, the position of the connection inlets does
not matter.
1.1.5. Connect the tubes to the 4 inlets on each leg cuff, making sure
to connect the longer tube to the topmost connector (darker in
colour) on the leg cuff (thigh).
1.2. Arm cuff
1.2.1. Put on the arm cuff and connect the tubes to the inlets on the
arm cuff itself, making sure to connect the longer tube to the
topmost connector (darker in colour) on the arm cuff;
CONNECTION
INLETS
VELCRO
ZIP
PRESSURE ORTHOTICS

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1.2.2. After connecting the tubes to the arm cuff, connect the tubes
to the air outlet connector on the machine.
USING EXTENSIONS
The extensions for the leg cuffs are an optional extra that allows you to increase
the size of the leg cuffs and can be requested by the customer at any time.
For correct use of the leg cuffs, use the zips on the leg cuffs and on the
extensions to join the two elements, as shown in the figure above.
Use of device
To use the I-PRESS device:
1. Plug the power cable into the mains socket.
2. Put on the applicators suitable for the treatment
you intend to perform and connect the relative
connector to the device body.
3. Adjust the pressure: the pressure can be adjusted
from 0 to 200mmHg (± 20%), i.e. the maximum
pressure that can be set, by slowly turning the knob
clockwise.
4. Adjust the therapy time: the therapy time can be set
from 0 to 30 minutes.

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WARNING! The device will immediately begin delivering
pressure into the worn applicators.
WARNING! Once the therapy has started, do not force the
timer by turning it anticlockwise. Wait for the end of the therapy
to set the desired time again.
5. Press the ON/OFF switch on the device body so that it
is ON.
6. At the end of the therapy, press the ON/OFF switch OFF.
7. It takes about 2 minutes for the air to flow into the
chambers inside the applicators. Only when ALL the
air has escaped from the chambers, unplug the
power cable from the mains socket.
8. Disconnect the applicator connectors from the device
body.
9. Remove the tube connection inlets from the applicators.
10. Store the device and all its applicators in their box.

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Recommended therapy settings
If the 8-ending tube is used by connecting both leg cuffs, it is suggested to set
the therapy pressures as follows:
You should always consult your doctor before using the device.
You should not excessively increase the pressure more the suggested values,
in order to avoid possible injuries.
Oedema: dedicated program for the reduction of oedema and resulting
inflammation.
Lymphedema: dedicated program for reducing the volume of the
lymphedematous limb.
Condition
Pressure
(mmHg)
Time (min)
Recommended
applicator
Therapy
cycle
Oedema
50
50
Leg cuff(s)
30 days
Lymphoedema
50
30
Leg/Arm cuff
30 days
Venous ulcers
50
60
Leg cuff(s)
30 days
Venous
insufficiency
50 60 Leg cuff(s) 30 days
Muscle
recovery
85 20 Leg cuff(s) 30 days
Condition
Pressure
(mmHg)
Time (min)
Therapy
cycle
Oedema
100
50
30 days
Lymphoedema
100
30
30 days
Venous ulcers
100
60
30 days
Venous
insufficiency
100 60 30 days
Muscle
recovery
170 20 30 days

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Venous ulcers: dedicated program for the treatment of venous ulcers in order
to speed up the healing process and reduce local pain.
Venous insufficiency: dedicated program for increasing blood perfusion in the
limbs.
Muscle recovery: dedicated program for the treatment of muscle pain and
stiffness after physical activity.
Looking after for the device
Maintenance
If used in accordance with the information reported herein, this device requires
no particular routine maintenance operations.
It is advisable to carry out a functional check of the device at the
manufacturer every 24 months.
The manufacturer does not consider the I-PRESS device to be
repairable by personnel outside the company itself. Any operation in this sense
by personnel not authorised by the manufacturer will be considered tampering
with the device, thereby avoiding the manufacturer's warranty and freeing it
from liability for any hazards to which the operator or user may be subjected.
CLEANING
It is advisable to switch off I-PRESS at the end of each therapy session, as well
as to remove the cables from the appropriate connectors.
WARNING: device cleaning must not be performed while the device is in
operation. Disconnect the device from the mains, disconnect all connection
cables and perform cleaning with the device switched off.
Use a soft dry cloth to remove any dust from the device. In case of hard to
remove dirt, use a cloth soaked in water and alcohol.
To clean the cuffs, use a soft cloth dampened if necessary, with a solution of
water and alcohol.
Wait until completely dry before using the device and applicators again.
The device does not require sterilisation.
Notes:

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−Never use solvents or chemicals for cleaning. Cleaning agents can
damage the device.
−Carry out routine maintenance, in particular:
•inspect the body of the device for cracks or fissures, which
may allow liquids to enter;
•inspect the cables.
Follow the above instructions only, for any other cleaning/maintenance
operations contact the manufacturer.
TRANSPORT AND STORAGE
Transport precautions
There is no particular care to be taken during transport as I-PRESS is a portable
device. However, it is recommended to put I-PRESS and the relative applicators
in the holder supplied after each use. Protect the device from intense heat,
direct sunlight and liquids. Store the device in a cool and well-ventilated
environment.
Do not place heavy objects on top of the device.
Storage precautions
Environmental operating conditions:
ambient temperature from +5 to + 40°C
relative humidity from 15 to 93%
pressure from 700 to 1060 hPa
Environmental storage conditions:
ambient temperature from +5 to + 40°C
relative humidity from 15 to 93%
pressure from 700 to 1060 hPa
Troubleshooting
Any type of work on I-PRESS must only be carried out by the manufacturer or
authorised dealer. In any case, before sending I-PRESS to the manufacturer, it
will be necessary ascertain the exact nature of the I-PRESS malfunction.
Check the following:
Problem
Solution
I-PRESS does not turn
on
1. Check the connection to the mains.
2. Check the power ON/OFF button.
3. Check the power cable is not damaged.