Gima AP500GIMA User manual

PROFESSIONAL MEDICAL PRODUCTS
PODOSCOPIO GIMA A LED
GIMA LED PODOSCOPE
PODOSCOPE LED GIMA
PODOSCOPIO LED GIMA
PODOSCÓPIO LED GIMA
LED-PODOSKOP GIMA
GIMA PODOSCOPE LED
GIMAN LED-PODOSKOOPPI
Manuale d’uso - User Manual - Notice d’utilisation - Manual del usuario - Manual do utilizador -
Gebrauchs- und instandhaltungsanleitung - Manual de utilizare - Ohjekirja
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 ma-
nuel avant d’utiliser le produit.
ATENCIÓN: Los operadores tienen que leer y entender com-
pletamente este manual antes
de utilizar el producto.
ATENÇÃO: Os operadores devem ler e entender completa-
mente este manual antes de usar
o produto.
ACHTUNG: Diese Anleitung muss vor dem Einsatz des Pro-
dukts aufmerksam gelesen und vollständig
verstanden werden.
ATENTIE: Operatorii trebuie sa citeasca
și înțelegeți pe deplin acest manual mai întâi
pentru a utiliza produsul.
HUOMIO: Käyttäjien on luettava
ja ymmärrä tämä käsikirja ensin täysin
käyttää tuotetta.
M27363-M-Rev.2.02.23
AP500GIMA (GIMA 27363)
Tecniwork S.p.A.
V.R.Benini 8 50013 Campi
Bisenzio (FI) Italy
Made in Italy
Gima S.p.A.
Via Marconi, 1 - 20060 Gessate (MI) Italy
[e-mail] - [e-mail]
www.gimaitaly.com

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ENGLISH
Chapter 1 GENERAL DESCRIPTION....................................................................... 13
1.1 General identication data.................................................................................... 13
1.2 Description and general characteristics................................................................ 13
1.3 Technical features and voltage............................................................................. 13
1.4 Classication and reference norms ...................................................................... 14
1.5 Electrical features of the podoscope .................................................................... 15
1.6 Components identication .................................................................................... 15
1.7 General safety warning ........................................................................................ 16
Chapter 2 INSTALLATION........................................................................................ 16
2.1 Trasport and stocking ........................................................................................... 16
2.2 Conditions for installation ..................................................................................... 16
2.3 Electric connection .............................................................................................. 19
Chapter 3 INSTRUCTIONS FOR USE...................................................................... 19
3.1 Use of the podoscope........................................................................................... 19
Chapter 4 MAINTENANCE ....................................................................................... 19
4.1 Ordinary maintenance .......................................................................................... 19
4.2 Disposal................................................................................................................ 20
4.3 Technical support.................................................................................................. 20
5 Gima warranty terms .............................................................................................. 20

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Chapter 1 GENERAL DESCRIPTION
1.1 General identification data
This instruction handbook is considered as an essential document
of podoscope AP500GIMA (GIMA 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.
All serious accidents concerning the medical device supplied by us must be reported to the ma-
nufacturer and competent authority of the member state where your registered office is located.
Company Name
Commercial Trademark: Gima
Typology: Podoscope
Model: AP500GIMA (GIMA 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)
Tecniwork S.p.A.
V.Benini 8 - 50013
Campi Bisenzio - FI - Italy
AP500GIMA (GIMA 27363)
VOLTAGGIO/
MAINS VOLTAGE
220-240V
FREQUENZA/
FREQUENCY
50/60 Hz
POTENZA/
POWER
7,5 VA
On each device you will nd a similar plate with the manufacturer’s
identication
1.2 Description and general characteristics
The particular system of light diffusion of the Podoscope AP500GIMA (GIMA 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

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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%
22 cm
8,67 in
42,5 cm
16,75 in
43,5 cm
17,12 in
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 AP500GIMA (GIMA 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 com-
patibility.”
Classication according to safety norm EN 60601-1:
- Portable device

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- 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 particu-
lar features of this device grant adequate protection and isolation against direct or indirect electric
shocksand against electric or mechanic surcharge.
The thermic power implied in this podoscope avoid dangerous overheating for materials and compo-
nents.
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
1
7 4
6
5
2
3
1 - Transparent methacrylate surface

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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

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
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
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 AP500GIMA (GIMA 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,

17 ENGLISH
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 pa-
tients to go on and down the podoscope.
120 cm 47.25 in
15 cm
5.9 in
Podoscope
Handle
Handle
100 cm
39.4 in
130 cm
51.19 in
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.
GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC EMISSIONS
The equipment AP500GIMA (GIMA 27363) is intended for use in the electromagnetic environment
specied below.
The customer or the user of the equipment AP500GIMA (GIMA 27363) should assu-
re that it is used in such an environment
Emissions test Compliance Electromagnetic environment – guidance

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RF emissions
CISPR 11 Group1 The equipment AP500GIMA (GIMA 27363) must emit
electromagnetic energy in order to perform its intended
function.
Nearby electronic equipment may be affected.
RF emissions
CISPR 11 Class B
The AP500GIMA (GIMA 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 purpose
Harmonic emissions
IEC 61000-3-2 Compliant
Voltage uctuations/
icker emissions
IEC 61000-3-3
Compliant
GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC IMMUNITY
The equipment AP500GIMA (GIMA 27363) is intended for use in the electromagnetic environment
specied below.
The customer or the user of the equipment AP500GIMA (GIMA 27363) should assure that it is used in
such an environment.
Immunity test IEC 60601
Test level Compliance level Electromagnetic environment guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
±2 KV contact
±4 KV contact
±6 KV contact
±2 KV air
±4 KV air
±8 KV air
±2 KV contact
±4 KV contact
±6 KV contact
±2 KV air
±4 KV air
±8 KV air
Floor should be wood, concrete
or ceramic tile. If oors are covered
with synthetic material, the relative
humidity should be at less 30%
Electrical fast
transient/burst
IEC 61000-4-5
±2 KV for power
supply lines
±2 KV for power
supply lines
Mains power quality should be
that of a typical commercial
or hospital environment
Surge
IEC 61000-4-5
±1 KV
differential mode
±2 KV common
mode
±1 KV
differential mode
±2 KV common
mode
Mains power quality should be
that of a typical commercial
or hospital environment
Voltage dips,short
interruptions and
voltage variations
on power supply input
lines
IEC 61000-4-11
<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
<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
Mains power quality should be
that of a typical commercial
or hospital environment.
If the user of AP500GIMA (GIMA
27363) requires
continued operation during
power mains interruptions,
it is reccomended that the
AP500GIMA (GIMA 27363) be
powered from an uninterruptible
power supply or a battery.

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Power frequency
(50/60 HZ) magnetic
eld
IEC 61000-4-8
3A/m 3A/m
Power frequency magnetic
eld should beat levels
characteristic of a typical
location in a typical commercial
or hospital environment.
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.
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ca-
tion of the original one.
In the case of troubles or needs to replace spare parts, always contact the producer.

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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.
Index of symbols
Caution: read instructions (warnings)
carefully Follow instructions for use
Keep in a cool, dry place Keep away from sunlight
Manufacturer Date of manufacture
Product code Lot number
Medical Device compliant with
Regulation (EU) 2017/ Medical Device
Device with applied part Type B WEEE disposal
Device of Class II
4.2 Disposal
Pursuant to legislative decree No. 49 of 14th March 2014, "Implementation of Directive
2012/19/EU on waste electrical and electronic equipment (WEEE)", the symbol of crossed-
out wheeled bin shown on the equipment indicates that at the end of its life the product
must be collected separately from other wastes.
Separate collection of the present equipment at the end of its life is set up and operated by
the manufacturer.The user who wishes to dispose of the present equipment shall therefore
have to contact the manufacturer and use the system adopted by the latter to allow the end-
of-life equipment to be separately collected.The proper separate collection of the discarded
equipment for subsequent recycling, treatment and environmentally sound disposa helps
to avoid potential negative consequences for the environment and human health and
favours the re-use and/or recycling of the materials the equipment consists of.The abusive
disposal of the product by its holder entails the enforcement of the administrative penalties
envisaged by applicable legislation.
4.3 Technical support
If you need technical support, please contact GIMA.
5 Gima warranty terms
The Gima 12-month standard B2B warranty applies.