Gima 27363 Bedienungsanleitung

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

gima@gimaitaly.com - export@gimaitaly.com

www.gimaitaly.com

Gima S.p.A.

Via Marconi, 1

20060 Gessate (MI) Italy

Made in Italy

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

ENGLISH

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

ENGLISH

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%

ENGLISH

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

ENGLISH

22 cm

8,67 in

42,5 cm

16,75 in

43,5 cm

17,12 in

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

7 4



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

ENGLISH

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.

ENGLISH

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

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

ENGLISH

120 cm

47.25 in

15 cm

5.9 in

Podoscope

Handle

100 cm

39.4 in

130 cm

51.19 in

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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