Gima 27363 User manual

PROFESSIONAL MEDICAL PRODUCTS
PODOSCOPIO - PODOSCOPE
PODOSCOPE - PODOSCOPIO
PODOSCÓPIO - PODOSKOP
Manuale d’uso
User Manual
Notice d’utilisation
Manual del usuario
Manual do utilizador
Gebrauchs- und instandhaltungsanleitung
ATTENZIONE: Gli operatori devono leggere e capire completamente questo manuale prima di utilizzare il prodotto.
ATTENTION: The operators must carefully read and completely understand the present manual before
using the product.
AVIS: Les opérateurs doivent lire et bien comprendre ce manuel avant d’utiliser le produit.
ATENCIÓN: Los operadores tienen que leer y entender completamente este manual antes de utilizar el producto.
ATENÇÃO: Os operadores devem ler e entender completamente este manual antes de usar o produto.
ACHTUNG: Diese Anleitung muss vor dem Einsatz des Produkts aufmerksam gelesen und vollständig
verstanden werden.
M27363-M-Rev.1.09.18
27363
Gima S.p.A.
Via Marconi, 1 - 20060 Gessate (MI) Italy
[e-mail] - [e-mail]
www.gimaitaly.com
Gima S.p.A.
Via Marconi, 1
20060 Gessate (MI) Italy
Made in Italy

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CONTENTS
Chapter 1 GENERAL DESCRIPTION........................................................15
1.1 General Identication data.........................................................15
1.2 General characteristics ..............................................................16
1.3 Technical features and voltage ..................................................16
1.4 Classication and reference norms ...........................................17
1.5 Electrical features and voltage...................................................18
1.6 Components identication.........................................................18
Electrical schema ......................................................................19
1.7 General safety warning ..............................................................19
Chapter 2 INSTALLATION .........................................................................20
2.1 Transport and stocking ..............................................................20
2.2 Conditions for installation ..........................................................20
2.3 Electric connection ....................................................................23
Chapter 3 ISTRUCTIONS FOR USE..........................................................23
3.1 Use of the podoscope ...............................................................23
Chapter 4 MAINTENANCE ........................................................................23
4.1. Ordinary maintenance................................................................23
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Chapter 1
GENERAL DESCRIPTION
1.1 General identification data
This instruction handbook is considered as an essential document
of podoscope 27363. Therefore they must not be separated in case
of cessation to third parties, in accordante with EC Directive 93/42/EC
and following norms.
This handbook gives the operator all the relevant information to carry out the
following operations correctly:
- INSTALLATION - USAGE - MAINTENANCE
Instructions for a correct installation are contained in the par.
2.2 CONDITIONS FOR THE INSTALLATION.
Follow the instructions for use
Read carefully this manual for the installation, the usage
and the maintenance of the podoscope.
COMPANY NAME
Commercial Trademark: Gima
Typology: Podoscope
Model: 27363
Manufacturer: Gima S.p.A. - Via Marconi, 1 20060 Gessate (MI) - Italy
IDENTIFICATION AND LABELS, SYMBOLS EXPLICATION
Warning: maximum load 135 kg (297 lbs)
On each device you will find a similar plate with the manufacturer’s
identification
Protection against indirect contacts: device of Class II
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Device with applied part Type B
Follow the instructions for use
Attention: danger
1.2 Description and general characteristics
The particular system of light diffusion of the Podoscope 27363 enables
you to study the patient’s foot plant and to mark the parts with the heaviest
pressure.
Its structure is very simple: the methacrylate structure is an excellent
light conductor and it is also endowed with an inner light source: in this way
you can discover variations of colour intensity on the foot plant,
corresponding to higher or lower plant pressure.
The base is of ABS.
A separable net cable with plug, a jack, and a led strip are its electric
components.
1.3 Technical features and voltage
Material Transparent methacrylate
Tension 220-240 V single-phase
Frequency 50/60 Hz
Power 7,5 A
Illumination Led Strip light
Wavelenght 520 nm
Risk Class EN 62471 Exempt
Nr. of included plugs Nr. 1
2 Fuses: 5x20 mm: 2 x T 0,5 A – 250 V
Conditions of use temperature: from 10°C up to 40°C
umidity: from da 20% up to 85%
Stocking conditions: temperature: from 0°C up to 60°C
umidity: from da 10% up to 90%
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Height 22 cm (8.67 in)
Total weight
(with package) Kg 9,0 (19.84 lb)
Maximum load Kg 135 (297 lb)
1.4 Classification and reference norms
The Podoscope 27363 allows to evaluate the foot print, supplying secondary
indirect information on the heel alignment and on the toes situation. It allows
to evaluate the signs and the symptoms of a particular condition of the foot,
in order to formulate a judgement on the health conditons and establish
a therapy or a chiropody treatment.
The device is designed and realized according to the law prescriptions
concerning electromedical equipment, and it’s therefore indicated for medical
purposes and used in clinics, consultation rooms and sports centres
by operators with knowledge of biomechanics, like doctors in sport medicine,
orthopedic specialists and physiotherapists.
Reference harmonized norms:
- CEI EN 60601-1 “Safety of electromedical devices”
- CEI EN 60601-1-2 “Collateral harmonized norm for electromedical devices –
Electromagnetic compatibility.”
Classication according to safety norm EN 60601-1:
- Portable device
- Class II
- Type B
- Ordinary protection against humidity
- Do never use with inammable anaesthetics
- Voltage: 220-240 V ~ 50/60 Hz.
The device highlights areas of the foot plant with heavest pressure thanks to
different intensity of light. In order to visualize them the patient just needs to
step on the podoscope barefoot. The particular features of this device grant
adequate protection and isolation against direct or indirect electric shocks
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22 cm
8,67 in
42,5 cm
16,75 in
43,5 cm
17,12 in

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and against electric or mechanic surcharge.
The thermic power implied in this podoscope avoid dangerous overheating
for materials and components.
Electric isolation and well-balanced distances between the surfaces avoid
the formation of electric arches. In addition to this, the podoscope has a solid
mechanical structure and an excellent stability on the ground.
It has no sharp edges, therefore there exists no danger of mechanical nature
both for operators and patients.
Each part of the inner circuits are assembled and xed in such a solid way
so as to stand up to the often adverse transport conditions.
As to indirect shocks, the device is classied in Class II.
As to current leakage it can be classied in class B.
No essential performance is dened for this device.
1.5 Electrical features of the podoscope
The conventional led power supply functions with single-phase current
(220-240 V - 50/60 Hz); the mark is ILC NanoLED.
The power cord - H05VV-F - 2 mt (6.56 ft) long, section 2 x 0.75 bears the
mark IMQ, has a two-pole plug and it is connected to the podoscope through
a connector.
The internal connectors of the power cord satisfy the norm CEI 20-20 (type H05V).
1.6 Components identification
ENGLISH
1
7 4
6
5
2
3

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
1 - Transparent methacrylate surface
2 - Basement in ABS (acrylonitrile butadiene styrene with wiring)
3 - Mirror
4 - Power cord jack
5 - On/Off switch
6 - Fuse holder
7 - Identication plate
Electric schema
1.7 General safety warning
As far as safety is concerned, this podoscope has undergone all the
necessary checks and inspections as foreseen.
In order to respect the safety prerequisites during the whole life of your
device, we suggest that you always take the following precautions:
A. Always unplug the podoscope during maintenance operations.
B. Do not move the podoscope while using it.
C. Each time before the usage, check the functioning of the cable
and of its electric parts.
D. Operators must not intervene or take any initiatives on the podoscope
which are not foreseen in this handbook.
Attention: do not charge the podoscope with loads over 135 kg
(297 lb) in order to avoid any risk of breaking
Attention: no change of the device is allowed
Net cable
with plug
220-240 V
50/60 Hz
O/I switch
with jack and
fuseholder
Internal connectors Podoscope
LED
strip
Power Supply
AC/DC
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Attention: not complying with warnings will relieve GIMA company
from any kind of responsibility.
Chapter 2
INSTALLATION
2.1 Trasport and stocking
Before shipping the podoscope 27363 is covered by a lm and packed
in a cardboard with protective panels inside.
The box contains the assembled podoscope and its cable (which must be
obviously connected to the apparatus before using it); the caoutchouc
is not included.
In case of a longer storage, please store the whole package clean and dry.
2.2 Conditions for installation
1. Unpack the podoscope completely.
2. Disposal of packing elements (plastic foams, polystyrene, polyethylene,
cardboard) must follow your local waste disposal guidelines.
3. Verify that the podoscope has not been damaged during transport. In case,
please contact the manufacturer immediately.
IMPORTANT Please take notice of the fact that light stripes and/or
microscopic luminescent dots on the transparent surface of the podoscope
are due to the particular nature of its material and do not impair
the equipment functionality.
RIGHT POSITIONING AND SAFETY INSTALLATION OF THE PODOSCOPE
Position the podoscope so as to leave enough room around it to be able to
safely operate and to connect and disconnect easily the device to the power
supply network.
We suggest to attach a handle on the wall as indicated in the scheme below
to make easier for patients to go on and down the podoscope.
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Electromagnetic compatibility (EMC)
The podoscope needs special precautions concerning electromagnetic
compatibility (EMC) and must be installed and operated according to the
EMC information contained in this manual.
In order to avoid possible risks of electromagnetic interferences, do not use
radio frequence portable or mobile devices near the podoscope.
Generally the podoscope should not be used near or together other
equipements; in the case this would not be possible, it’s necessary to observe
its operativity to verify the normal functioning.
Emissions test
RF emissions
CISPR 11
RF emissions
CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage uctuations/
icker emissions
IEC 61000-3-3
Compliance
Group1
Class B
Compliant
Compliant
Electromagnetic environment – guidance
The equipment 27363 must emit electromagnetic
energy in order to perform its intended function.
Nearby electronic equipment may be affected.
The 27363 is suitable for use in all establishments
other than domestic and those directly connected
to the public low-voltage power supply network
that supplies buildings used for domestic purposes
GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC EMISSIONS
The equipment 27363 is intended for use in the electromagnetic environment specied below.
The customer or the user of the equipment 27363 should assure that it is used in such an environment
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120 cm 47.25 in
15 cm
5.9 in
Podoscope
Handle
Handle
100 cm
39.4 in
130 cm
51.19 in

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ENGLISH
Immunity test
Electrostatic
discharge (ESD)
IEC 61000-4-2
Electrical fast
transient/burst
IEC 61000-4-5
Surge
IEC 61000-4-5
Voltage dips,short
interruptions and
voltage variations
on power supply input
lines
IEC 61000-4-11
Power frequency
(50/60 HZ) magnetic
eld
IEC 61000-4-8
IEC 60601
Test level
±2 KV contact
±4 KV contact
±6 KV contact
±2 KV air
±4 KV air
±8 KV air
±2 KV for power
supply lines
±1 KV
differential mode
±2 KV common
mode
<5% UT
(>95% dip in UT)
for 0,5 cycle
40% UT
(60% dip in UT)
for cycle
70% UT
(30% dip in UT)
for cycle
<5% UT
(>95% dip in UT)
for 5 s
3A/m
Electromagnetic environment
guidance
Floor should be wood, concrete
or ceramic tile. If oors are covered
with synthetic material, the relative
humidity should be at less 30%
Mains power quality should be
that of a typical commercial
or hospital environment
Mains power quality should be
that of a typical commercial
or hospital environment
Mains power quality should be
that of a typical commercial
or hospital environment.
If the user of 27363 requires
continued operation during
power mains interruptions,
it is reccomended that the 27363
be powered from an uninterruptible
power supply or a battery.
Power frequency magnetic
eld should beat levels
characteristic of a typical
location in a typical commercial
or hospital environment.
GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC IMMUNITY
The equipment 27363 is intended for use in the electromagnetic environment specied below.
The customer or the user of the equipment 27363 should assure that it is used in such an environment
Compliance
level
±2 KV contact
±4 KV contact
±6 KV contact
±2 KV air
±4 KV air
±8 KV air
±2 KV for power
supply lines
±1 KV
differential mode
±2 KV common
mode
<5% UT
(>95% dip in UT)
for 0,5 cycle
40% UT
(60%dip in UT)
for cycle
70% UT
(30% dip in UT)
for cycle
<5% UT
(>95% dip
in UT) for 5 s
3A/m

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2.3 Electric connection
Connect your podoscope verifying that the indications on the plate
correspond to the local electric voltage, then plug it into the socket
which must be supplied with a surcharge safety device.
The use of accessories, transducers and cables, except the ones sold
by the producer as spare parts, can increase the emissions and decrease
the EM (electromagnetic) device immunity.
Chapter 3
INSTRUCTIONS FOR USE
3.1 Use of the podoscope
Plug the podoscope in to light it up, then switch on (5) to position I.
Let the patient step on the transparent basis of the podoscope and make
sure that the feet are right in the centre of it. Then proceed with a sight
examination on the mirror.
If have not been supplied caoutchouc the examination can be performed
only if the patient is barefoot, otherwise lay the caoutchouc on the
transparent surface. This material is also useful to check the validity of arch
support treatments.
Warning: don’t let step on patients with injured foot skin
At the end of the examination, press (5) again to put it back to the 0 position
and turn it off.
IMPORTANT: please help elderly patients step on the podoscope
and remain steady
Chapter 4
MAINTENANCE
4.1 Ordinary maintenance
The ordinary maintenance described in this paragraph can be carried out
directly by the operator.
1. Disinfect the surface of the podoscope after each use with disinfectants
indicated for this material: never use alcohol nor solvents for this purpose.
2. Clean the podoscope at least once a week, always after having unplugged
it. Use clean clothes, slightly moistened with water and detergent for
glasses. Never use alcohol nor solvents for this purpose.
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3. The frequency of the checks on internal wiring may vary according to
external conditions (i.e. presence of dust) and repeated usage.
4. As a general rule, we recommend a sight inspection every six months or at
least within one year after the purchase of the podoscope, to ascertain
whether there is no wear and tear in the cable or in the electric
connections.
If you have to replace one of the fuses, open the fuse holder placed in the
position indicated in the picture on page 19.
Then get out the blown fuse with a suitable instrument and replace it with
a T 0,5 A – 5x20 250V fuse.
If you have to replace the power cord, the new one must have the same
characteristics and certication of the original one.
In the case of troubles or needs to replace spare parts, always contact the
producer.
WARNING: all maintenance should be done only after
disconnecting the device from the electrical mains.
LED REPLACEMENT
In case of troubles with LED, please contact the Technical Assistance Service.
Do not make direct operations, as Warranty shall become void.
WARNING: all the operations to replace led should be made only
by the authorized technical assistance.
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Disposal: The product must not be disposed of along with other
domestic waste. The users must dispose of this equipment by
bringing it to a specific recycling point for electric and electronic
equipment. For further information on recycling points contact
the local authorities, the local recycling center or the shop where
the product was purchased. If the equipment is not disposed
of correctly, fines or penalties may be applied in accordance
with the national legislation and regulations.
GIMA WARRANTY CONDITIONS
Congratulations for purchasing a GIMA product. This product meets high
qualitative standards both as regards the material and the production.
The warranty is valid for 12 months from the date of supply of GIMA.
During the period of validity of the warranty, GIMA will repair and/or replace
free of charge all the defected parts due to production reasons.
Labor costs and personnel traveling expenses and packaging not included.
All components subject to wear are not included in the warranty.
The repair or replacement performed during the warranty period shall
not extend the warranty. The warranty is void in the following cases:
repairs performed by unauthorized personnel or with non-original spare
parts, defects caused by negligence or incorrect use. GIMA cannot be held
responsible for malfunctioning on electronic devices or software due to
outside agents such as: voltage changes, electro-magnetic elds, radio
interferences, etc. The warranty is void if the above regulations are not
observed and if the serial code (if available) has been removed, cancelled
or changed.
The defected products must be returned only to the dealer the product was
purchased from. Products sent to GIMA will be rejected.
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