Gima 35607 DRY STERILIZER "GIMETTE 7" Owner's Manual

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Gima 35607 DRY STERILIZER

MANUALE D’USO

USER’S GUIDE / MANUEL D’UTILISATION

Sterilizzatrice ad aria calda

Hot air sterilizer / Stérilisateur à air chaud

GIMETTE 1,5

Art. 35601

GIMETTE 7

Art. 35607

Distribuito da:

GIMA Spa

Via Marconi, 1 – 20060 Gessate (MI)

P.IVA: 00734640154

E-m@il Italia: [email protected]

E-m@il Export: [email protected]

Manuale cod. 8002GIMA – Ed.0/Rev.2

FAST ASSEMBLER S.r.l.

P.le Cadorna, 13

20123 Milano – Italia [email protected]

0425

FAST ASSEMBLER - GIMETTE 1,5 - 7

Manuale cod. 8002GIMA – Ed.0/Rev.2

INDICE

TABLE OF CONTENTS / INDEX

0) Identificazione /

Classification / Identification

1) Riferimenti normativi /

Normative ref. / Référence de normes

2) Scheda dati tecnici /

Technical data / Fiche des données techniques

3) Descrizione /

Description / Description

3 1

3 2

: pannello di controllo /

control panel / panneau de contrôle

: schema elettrico /

circuit diagram / schéma électrique

4) Istruzioni /

Instructions / Instructions

4 -

1

: trasporto /

carriage / transport

4 -

2

: installazione e preparazione per l’uso /

installation and start up / installation et préparation pour l’emploi

4 -

3

: utilizzazione /

instructions for use / utilisation

4 -

4

: manutenzione e riparazioni /

maintenance and repairs / entretien et réparations

4 -

5

: messa fuori uso /

putting out of service / mise hors service

5) Norme di sicurezza /

Safety cautions / Normes de sécurité

6) Precauzioni durante l’uso /

Cautions to the user / Précautions pendant l’utilisation

7) Responsabilità del produttore /

Manufacturer’s responsibility / Responsabilité du constructeur

8) Garanzia /

Warranty / Garantie

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0) Identificazione /

Classification / Identification

♦ Sterilizzatrice aria calda / Hot air sterilizer / Stérilisateur à air chaud :

“ Gimette “

♦ Modello / Model l Modèle :

- Gimette 1,5

- Gimette 7

♦ Anno di costruzione / Manufacturing year / Année de construction :

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2) Scheda dati tecnici /

Technical data / Fiche des données techniques

Capacità

Capacity / Capacité

Assorbimento

Absorbed power / Puissance absorbée

Tensione - Frequenza

Voltage - Frequency /

Tension - Fréquence

Fusibile

Fuse / Fusible

Timer

Timer / Minuterie

Gimette 1,5 = >1,5 lt.

Gimette 7 = 7 lt.

Gimette 1,5 = 250 Watt – 205 Ohm

Gimette 7 = 400 Watt – 125 Ohm

230 Volt – 50/60 Hertz

Termostato

Thermostat

2° Termostato di sicurezza

2nd safety thermostat /

2° thermostat de sécurité

Termometro

Thermometer / Thermomètre

Gimette 1,5 = 1 A/F – 250 V – L 35A

Gimette 7 = 2,5 A/F – 250 V – L 35A

Meccanico 0 ÷ 120 min.+ posizione manuale /

Mechanical type 0 ÷ 120 min.+ manual position /

Mécanique 0 ÷ 120 min. + position manuelle

Regolabile a capillare 0÷200°C +/- 6°C

Adjustable with capillary tube 0÷200°C +/- 6°C

Réglable à capillaire 0÷200°C +/- 6°C

Bimetallo a riarmo automatico 190°C +/-7.5 diff. 13°C

Certified bimetallic thermostat 190°C +/-7.5 diff. 13°C

Bimétal à réarmement automatique 190°C +/-7.5 diff.13°C

Con bulbo capillare

With capillary and bulb

Avec bulbe capillaire

Risoluzione 5°C (per il solo modello Gimette 1,5)

Resolution 5°C / Résolution 5°C (only/seulement Gimette 1,5)

Gimette 1,5 = cm. 32 x 22 x 21

Gimette 7 = cm. 49 x 33 x 23

Ingombro (l.p.h.)

Overall size (w.d.h.) /

Encombrement (l.p.h.)

Misure int. (l.p.h.)

Int. size (w.d.h.) /

Mesures internes (l.p.h.)

Peso

Weight / Poids

Grado di protezione IP

Protection IP degree /

Degré IP de protection

Gimette 1,5 = cm. 24,5 x 12 x 5

Gimette 7 = cm. 41 x 18 x 9

Condizioni ambientali normali

Normal environmental conditions /

Conditions normaux environnementaux

Dispositivo Medico

Medical Device / Dispositif Médical

Gimette 1,5 = Kg. 4,3 approx.

Gimette 7 = Kg.8 approx.

Grado di protezione IP 41 per apparecchiatura da laboratorio (EN 60529)

Protection IP 41 degree for laboratory device (EN 60529) /

Degré IP 41 de protection pour dispositif de laboratoire

La norma di riferimento EN 61010-1 specifica le condizioni ambientali normali di impiego definite per uso interno, altitudine sino m.2000, temperature comprese tra 5 ÷ 40°C, umidità relativa max 80% sino a 31°C,presenza della terra nella rete di alimentazione.

EN 61010-1 rule defines the environmental normal conditions of the utilization which are fixed for internal use, altitude till m.2000, temperatures between 5 ÷ 40°C, relative humidity max 80% till 31°C, presence of the ground in the feeding net.

La règle EN 61010-1 définit les conditions normaux environnementaux de l'utilisation qui sont fixes pour l'usage interne, l'altitude jusqu'à m.2000, les températures entre le 5÷40°C, l'humidité relative maximum 80% jusqu'à

31°C, présence de la terre dans le filet d'alimentation.

Classe II B

Class II B

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3) Descrizione /

Description / Description

Our hot air sterilizers are designed to allow a quick and safe sterilization of surgical instruments without envelope, in accordance with denominated method dry heat.

The sterilization chamber is entirely made of stainless steel resistant to heat and corrosion. It is fully insulated with glassfibre to avoid the overheating of external side. The door closes sterilization chamber hermetically by means of a silicon gum gasket resistant to heat. The sterilizer has an extractable aluminium tray with big slots for warm air circulation. There is a stainless steel electric immersion heater, characterized by high efficiency and little inertia. The automatic control of temperature is obtained with a capillary bulb automatic thermostat as auto-adjustment up to 200°C. If the temperature exceeds the limit set up during the test, a second safety bimetallic thermostat takes control. The working of the second thermostat causes the alarm red pilot lamp lighting up. To program the thermostat starting time, it is possible to use the timer up to 120 minutes or by the fixed timer on the manual position.

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The required temperature and time setting, is obtained by means the thermostat and timer knobs.

The device is provided with a green bright main power switch and with green, orange and red pilot lamps to show respectively the working, heating and alarm signals. The sterilizer is delivered with certified feeder cable, one extractable aluminium tray, two holder-tray pliers.

3.1 Pannello di controllo /

Control panel / Panneau de contrôle

Fig. 1

1) timer / minuterie

2) termostato / thermostat

3/4) spia verde / green light / voyant lumineux vert

4/3) spia arancione / orange light / voyant lumineux orange

5) spia rossa / red light / voyant lumineux rouge

6) termometro / thermometer / thermomètre

************

Fig. 2

Cassettino estraibile porta-fusibile / Exctractable fuse block / Boitier extractible porte-fusible

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3.2 Schema elettrico /

Circuit diagram / Schéma électrique

Gimette 1,5

F fusibile rapido 5x20mm – 1A/F – 250V – L 35A

IG interruttore generale unipolare luminoso verde 16(6)A – 250V

L fase

LSA spia luminosa arancione 1/4W – 2mA – 250V – 150KΩ – 25000 ore vita media

LSR spia luminosa rossa 1/4W – 2mA – 250V – 150KΩ – 25000 ore vita media

LSV spia luminosa verde 1/4W – 2mA – 250V – 150KΩ – 25000 ore vita media

N neutro

NP terra

PE messa a terra

R resistenza 250W – 220V - 205Ω

S spina con portafusibile 10A - 250V

T timer 1 via 120’ – 0°÷280° + pos.man. -50° - 16(3)A – 250V

TR termostato regolabile 0÷200°C ±6°C diff. 6°C – 0°÷280° - 16(3)A – 250V

TS termostato sicurezza 190°C ±7,5°C diff. 13°C – 10A – 250V – T amb. 300°C max.

Gimette 7

F fusibile rapido 5x20mm – 2.5A/F – 250V – L 35A

IG interruttore generale unipolare luminoso verde 16(6)A – 250V

L fase

LSA spia luminosa arancione 1/4W – 2mA – 250V – 150KΩ – 25000 ore vita media

LSR spia luminosa rossa 1/4W – 2mA – 250V – 150KΩ – 25000 ore vita media

LSV spia luminosa verde 1/4W – 2mA – 250V – 150KΩ – 25000 ore vita media

N neutro

NP terra

PE messa a terra

R resistenza 400W – 220V - 125Ω

S spina con portafusibile 10A - 250V

T timer 1 via 120’ – 0°÷280° + pos.man. -50° - 16(3)A – 250V

TR termostato regolabile 0÷200°C ±6°C diff. 6°C – 0°÷280° - 16(3)A – 250V

TS termostato sicurezza 190°C ±7,5°C diff. 13°C – 10A – 250V – T amb. 300°C max.

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4) Istruzioni /

Instruction / Instructions

4.1 Trasporto /

Carriage / Transport

The sterilizer is shipped in an adequate package which requires the common handling cautions for fragile materials, as shown on the package itself. Use only the original package if the equipment must be returned to the manufacturer. To carry the sterilizer without package, keep it in a horizontal position and use the base as holding point.

Note : the cardboard package doesn’t require particular waste disposal conditions.

4.2 Installazione-preparazione per l’uso /

Installation and start up / Installation

Remove the equipment from the package handling with care. Check the power supply system is correctly grounded. Place the sterilizer on a level surface so that air can freely circulate under the equipment bottom side. Keep the back side of the sterilizer at least 10cm. away from walls to ensure an adequate ventilation. Insert the tray in its housing. Insert the safety plug of the power supply cable, firstly into the equipment socket and then into the electric system, after being sure the voltage corresponds to the one selected on the device.

Press the green main power switch position “I”. Check if the switch light is on.

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Note : in case you find a damp package, it is recommended to leave the unit in a heated room to exclude humidity conditions of the components.

Note : a typical smell of heated glassfibre may be present at the first power on and remain for a short period of time.

Note : you can find the environmental required conditions (pressure, humidity, temperatures, etc.) inside the technical data page, as the reference rules.

4.3 Utilizzazione /

Instructions to use / Utilisation

Press the main power switch position “I”.

Turn the timer knob (nr.1) clockwise, positioning the index on the required time, up to

120 minutes.

Turn the thermostat knob, positioning the index on the required temperature (we tested and got ready the sterilizer to work in optimal conditions at 180°C.).

Tourner le bouton du thermostat en amenant l’index sur la température désiré (le stérilisateur est essayée et préparée pour travailler en conditions optimales à 180°C.).

Check the lighting of the orange light. The orange light (nr.4) (whose lighting points out the working of the electric heater) will have some automatic clicks because of heat distribution into the sterilization chamber, before stabilizing on the required temperature.

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When the device is cold, the required temperature will be reached in 40min.approx. The suggested temperature is pointed out blue (150°C-180°C).

To disconnect the timer and to make the sterilization work for an indefinite time, turn the timer knob anticlockwise, on the “Manual” position.

For a correct use and a good circulation of hot air, we recommend do not fill up the tray excessively, and we recommend do not put one instrument on another. When the required temperature is reached, the sterilization times – according to the material - vary from min.30 minutes up to max.120 minutes with temperature 150÷180°C max. according to the directions of “Farmacopea Ufficiale” and the medical devices manufacturers. The user must to value if the instruments’ quality and characteristics, during the process, can exclude a deterioration of the products which are treated. It is important to specify the sterilization process is just only a part included in a more complex procedure which concerns the Decontamination, the Cleansing, the Sterilization and the Curing phases. The correct application of this procedure, the periodical activities of the chamber cleaning, can be exclude a crossed contamination. Do not keep the thermostat highest temperature for a long time, in order not to risk of spoiling the sterilized material.

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The lighting up of the red light (nr.5) “Alarm” indicates the temperature is going over 220°C and the second safety thermostat is working limiting the temperature. Let the service or the specialized technician verify the efficiency of the adjustable thermostat. About the sterilizers models without a thermometer it will be opportune a periodical check of the thermic performance to warrant the set up processes.

Note : periodically check with proper indicators, the heat homogeneous distribution inside the chamber.

4.4 Manutenzione e riparazioni /

Maintenance and repairs / Entretien et réparations

Always check the power is unplugged before maintenance is carried out. The sterilizer needs no particular maintenance, provided the adequate environment are satisfied, except for a regular cleaning of its external parts. It is recommended to clean the equipment with a soft cloth and water. Do not use acids or solvents.

Regularly check if the power cable is in good conditions.

It is possible to replace the safety fuse pulling out the fuse block at the rear under the socket (fig.2). Please always follow the characteristics stated in the technical data sheet.

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If any repairs are needed, please return the equipment directly to the manufacturer or to the local distributor using only the original package. However it is possible to contact specialized technicians, who must work in accordance to general safety and accident prevention rules of the country in which the equipment is installed.

4.5 Messa fuori uso /

Putting out of service / Mise hors service

No particular cautions. In any case, about the waste process, it must be applied the required procedures by the rule in force and the EU Directives. Even though the sterilizer doesn’t fall inside the table of the devices provided of the Annex RAEE Directive, in any case the unit has been conceived with a selection of components according to such Directive. N.B.

From the technical point of view, the life of the device is related to the characteristics of the components used to manufacture the device itself, and it is not related to its execution from Fast Assembler side.

5) Norme di sicurezza /

Safety cautions / Normes de sécurité

This equipment must be only used from authorized personnel informed on the correct use.

These sterilizers must be only used for their designed purpose : to sterilizer surgical instruments or tools in the medical and paramedical field. The sterilizers must not be used for all treatments concerning contact lenses (Rule 15 - All.9 - Comma 1).

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It is necessary to take all precautions to avoid unauthorized use.

Do not modify, change or put out of order any electrical or thermal safety protection of the equipment. Check regularly the functionality of the light indicators which signal the feeding and the heating phases.

When the sterilizer is operating, pay attention to the people near the equipment.

The user must not attempt to carry out any repair unless authorized.

Do not clean or repair the sterilizer while it is connected to an electrical system and be sure the sterilization chamber is at room temperature. Check regularly if the power cable is damaged.

When authorized technicians decide to replace spare parts, they must use original replacements and moreover they must adhere to the manufacturer’s information and technical characteristics.

In case of any doubt about safety rules, please contact the manufacturer or local distributor before using the equipment.

However use the sterilizer in accordance with the general safety and accident prevention rules of the country in which the equipment is installed.

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ATTENZIONE !!

ATTENTION !!

Avoid the accidental contact with liquids.

The sterilizer does not have to be used in an environment where the explosive gases may be present.

6) Precauzioni durante l’uso /

Cautions to the user / Précautions pendant l’utilisation

Place the sterilizer on a level surface so that air can freely circulate under the equipment bottom side.

Keep the sterilizer at least 10cm. away from walls to ensure an adequate ventilation. Keep the door closed when the sterilization process is running. Do not place any object on the upper part of the equipment. To extract the tray and fit it in, use the appropriate holder-tray pliers. Do not clean, move or repair the sterilizer while is connected to an electrical system and the sterilization chamber is still

ATTENZIONE !!

ATTENTION !!

When the sterilizer is operating do not put hands inside the sterilization chamber and do not touch the tray.

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7)

Responsabilità produttore /

The sterilizer must be only used for its designed purpose. Improper use of the equipment is to the risk and sole responsibility of the user.

8)

Garanzia /

Warranty / Garantie

The warranty covers only equipment with production and natural defects as indicated in the certificate that comes with the device.

Spiegazione dei simboli

/ Symbols explanation / Explication des symboles

I = interruttore generale acceso / main power switch on / interrupteur général allumé

0 = interruttore generale spento / main power switch off / interrupteur général éteint

AVVERTENZA

Symbol / Symbol

PRECAUZIONI

Precautions / Précautions

PERICOLO

Danger

Elettrico

Electric

Électrique

Executing maintenance operations isn’t allowed on device with voltage tension presence.

It is compulsory all the operations inside the electrical equipment, must be only carried out from authorized personnel informed on the correct use.

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PERICOLO

Danger

Dangerous temperature surface indication.

AVVERTENZA

Symbol / Symbol

PRECAUZIONI

Precautions / Précautions

Executing maintenance, cleaning, etc.operations isn’t allowed on device before it is at room temperature.

Grounding

It is necessary that the feeding net assures an effective grounding in order to obtain the necessary protection.

User Manual

We recommend to read the user manual before using the device.

S’il vous plait lire manuel utilisation avant

______________________________________________________________________________________

Rev. 2 del 02/2017

FAST ASSEMBLER S.r.l.

P.le Cadorna, 13

20123 Milano – Italia [email protected]

0425

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