Gima MINI ASPEED BATTERY PRO User guide

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MINIASPEED BATTERY PRO

ISTRUZIONI D’USO

INSTRUCTION MANUAL

MANUEL D’INSTRUCTIONS

MONTAGE-UND GEBRAUCHSANWEISUNG

MANUAL DE INSTRUCCIONES

DESCRIZIONE FUNZIONAMENTO LED / LED OPERATION DESCRIPTION

DESCRIPTION DU FONCTIONNEMENT DES LED / BESCHREIBUNG DER FUNKTIONSWEISE DER LED /

DESCRIPCIÓN DEL FUNCIONAMIENTO DE LEDS

Led rosso lampeggiante: la batteria non è più in grado di fornire la massima autonomia, provvedere alla sua sostituzione / Flashing red Led: the battery is no longer capable of supplying maximum autonomy; replace it. / Led rouge clignotante: la batterie n’est plus en mesure d’assurer l’autonomie maximale, la remplacer. / Rote LED blinkt: Die Batterie ist nicht mehr in der Lage, maximale Autonomie zu liefern. Batterie ersetzen./ Led rojo parpadeante: la batería ya no logra ofrecer la autonomía máxima; sustituirla.

Led rosso ﬁsso: la batteria è scarica, utilizzare l’apparecchio per 3 minuti massimo e provvedere alla ricaricare la batteria. / Red Led permanently on: the battery is ﬂat: use the appliance for a maximum of 3 minutes and re-charge the battery. / Led rouge ﬁxe: la batterie est déchargée, utiliser l’appareil pendant 3 minutes au maximum puis recharger la batterie. / Rote LED leuchet kontinuierlich: Batterie entladen. Das Gerät maximal für 3 Minuten benutzen und die Batterie auﬂaden./ Led rojo ﬁjo: la batería está agotada, utilizar el aparato durante 3 minutos como máximo y volver a cargarla.

Led giallo ﬁsso: la batteria è in riserva (autonomia 10 minuti circa), se possibile provvedere a ricaricarla. / Yellow Led permanently on: the battery is in reserve (around 10 minutes autonomy), se possible, recharge it. / Led jaune ﬁxe: la batterie est sur la réserve (10 minutes d’autonomie environ); la recharger si possible. / Gelbe LED leuchet kontinuierlich: Batterie in Reserve (Autonomie ca. 10 Minuten), Batterie auﬂaden. / Led amarillo ﬁjo: la batería se halla en reserva (autonomía de unos 10 minutos); si es posible volver a cargarla.

Led verde ﬁsso: apparecchio in funzione, batteria carica. Led verde lampeggiante: batteria sotto carica. / Green Led permanently on: appliance operating: battery charged. Green Led ﬂashing: battery under charge. / Led verte ﬁxe: appareil en marche, batterie chargée. Led verte clignotante: batterie sous charge. / Grüne LED leuchet kontinuierlich: Gerät in Betrieb, Batterie geladen. Grüne LED blinkt: Batterieauﬂadung. / Led verde ﬁjo: aparato funcionando, batería cargada. Led verde parpadeante: batería en carga.

SCHEMA DI COLLEGAMENTO / CONNECTION DIAGRAM

SCHÉMA DE RACCORDEMENT / ANSCHLUSSPLAN

ESQUEMA DE CONEXIÓN

1. Aspiratore

1a. Presa per alimentatore multitensione e ricarica batteria 1b. LED di funzionamento 1c. Interruttore ON-OFF 1d. Regolatore di vuoto 1e. Presa entrata-aria INLET 1f. Vuotometro

2. Vaso da 1000 ml in policarbonato sterizzabile

2a. Tappo in polipropilene sterilizzabile 2b. Guida galleggiante in polipropilene sterilizzabile 2c. Corpo galleggiante in polipropilene sterilizzabile 2d. Valvola in gomma sterilizzabile

3. Filtro antibatterico monouso

4. Tubo in silicone sterilizzabile Ø 6x12 mm L 240 mm

5. Tubo in silicone sterilizzabile Ø 6x12 mm L 1300 mm

6. Regolatore manuale sterile monouso

7. Cannula sterile monouso

8. Sacca monouso

9. Cavo di alimentazione

10. Alimentatore multitensione

11. Cavo con spina accendisigari

12. Borsa con tracolla

1. Aspirator

1a. Multi-voltage power supply unit and battery charger socket 1b. Power LED 1c. ON-OFF switch 1d. Vacuum regulator 1e. Air INLET connection 1f. Vacuum gauge

2. 1000 ml vessel in sterilisable polycarbonate

2a. Sterilisable polypropylene cap 2b. Sterilisable polypropylene float guide 2c. Sterilisable polypropylene float body 2d. Sterilisable rubber valve

3. Disposable antibacterial filter

4. Sterilisable silicone tube Ø 6 x 12 mm L 240 mm

5. Sterilisable silicone tube Ø 6 x 12 mm L 1300 mm

6. Disposable sterile manual regulator

7. Disposable sterile cannula

8. Disposable bag

9. Power cord

10. Multi-voltage power supply unit

11. Cable with cigarette lighter plug

12. Bag with shoulder strap

1. Aspirateur

1a. Prise pour alimentation multi-tension et recharge de la batterie 1b. LED de fonctionnement 1c. Interrupteur MARCHE/ARRÊT 1d. Régulateur de vide 1e. Prise d’arrivée d’air INLET 1f. Vacuomètre

2. Récipient de 1000 ml en polycarbonate

stérilisable 2a. Bouchon en polypropylène stérilisable 2b. Guide flottant en polypropylène stérilisable 2c. Corps flottant en polypropylène stérilisable 2d. Soupape en caoutchouc stérilisable

3. Filtre antibactérien jetable

4. Tuyau en silicone stérilisable Ø 6x12 mm

L 240 mm

5. Tuyau en silicone stérilisable Ø 6x12 mm

L 1300 mm

6. Régulateur manuel stérile jetable

7. Canule stérile jetable

8. Poche jetable

9. Câble d’alimentation

10. Alimentation multi-tension

11. Câble avec fiche allume-cigare

12. Sac bandoulière

1. Absauggerät

1a. Buchse für Mehrspannungsnetzteil und Batterieaufladung 1b. Funktions-LED 1c. Schalter ON-OFF 1d. Vakuumregler 1e. Lufteinlassbuchse INLET 1f. Unterdruckmesser

2. 1000 ml-Sekretbehälter aus sterilisierba-

rem Polycarbonat 2a. Sterilisierbarer Polypropylendeckel 2b. Schwimmführung aus sterilisierbarem Polypropylen 2c. Schwimmkörper aus sterilisierbarem Polypropylen 2d. Sterilisierbares Gummiventil

3. Antibakterieller Einwegfilter

4. Sterilisierbarer Silikonschlauch Ø 6x12

mm L 240 mm

5. Sterilisierbarer Silikonschlauch Ø 6x12

mm L 1300 mm

6. Steriler Einweghandregler

7. Sterile Einwegkanüle

8. Einwegbeutel

9. Netzkabel

10. Mehrspannungsnetzteil

11. Kabel mit Zigarettenanzünderstecke

12. Schultertasche

1. Aspirador

1a. Enchufe para alimentador multitensión y recarga batería 1b. LED de funcionamiento 1c. Interruptor ON-OFF 1d. Regulador de vacío 1e. Toma de entrada-aire INLET 1f. Vacuómetro

2. Recipiente de 1000 ml en policarbonato

esterilizable 2a. Tapón de polipropileno esterilizable 2b. Guía ﬂotador de polipropileno esterilizable 2c. Cuerpo ﬂotador de polipropileno esterilizable 2d. Válvula de goma esterilizable

3. Filtro antibacteriano desechable

4. Tubo de silicona esterilizable Ø 6x12 mm

L 240 mm

5. Tubo de silicona esterilizable Ø 6x12 mm

L 1300 mm

6. Regulador manual estéril desechable

7. Cánula estéril desechable

8. Bolsa desechable

9. Cable de alimentación

10. Alimentador multitensión

11. Cable con toma de mechero

12. Bolsa con bandolera

Schema di collegamento con Vaso - ﬁg. 1 Connection with vessel - ﬁg. 1 Schéma de raccordement au récipient - ﬁg. 1 Anschlussplan mit Sekretbehälter - Abb. 1 Esquema de conexión con Recipiente - ﬁg. 1

Fig - Abb. 1

Schema di collegamento con Sacca monouso - ﬁg. 2 Connection with disposable bag - ﬁg. 2 Schéma de raccordement avec poche jetable - ﬁg. 2 Anschlussplan mit Einwegbeutel - Abb. 2 Esquema de conexión con Bolsa desechable - ﬁg. 2

ACCESSORI / ACCESSORIES / ACCESSOIRES / ZUBEHÖR / ACCESORIOS

6. 7. 8. 3.

9. 10. 11 . 12.

Fig - Abb. 2

The MINIASPEED BATTERY PRO aspirator, specific for secretion removal, is a medical and surgical device suitable for use in the home, in clinics, and also in field facilities and on vehicles. This model is equipped with a 12 V rechargeable battery, which enables the device to operate with no mains power available. It can also be powered via a 12 V cigarette lighter socket. The device generates a vacuum for aspira tion to extract bodily fluids through a disposable cannula connected to a collection vessel, where they are collected for appropriate disposal. Its use must be prescribed by a physician. For correct operation and a longer service life, carefully follow the use and cleaning instructions. The device includes a vacuum regulator, vacuum gauge and 1000 ml vessel with a safety device that prevents liquid from entering the suc tion pump, which would cut out the suction flow. It never needs lubrication. It is sturdy, silent, reliable, easy to handle and simple to operate. The MINIASPEED BATTERY PRO aspirator includes the following accessories: 1000 ml vessel with safety device, power cord with multi- voltage power supply, power cord with cigarette lighter plug, short sterilisable silicone connection tube, long sterilisable silicone connec tion tube, disposable, sterile cannula, disposable, sterile manual regulator, disposable bag and a disposable antibacterial filter.

N.B.: Only use genuine accessories supplied by 3A Health Care; the accessories supplied with the device by the manufac turer have been tested and proven compliant with the latest current safety standards. WARNING! Correct operation of the device is not guaranteed in the event of use of accessories other than those supplied.

Battery-powered medical / surgical aspirator intended for use in the ﬁeld and/or in vehicles. It may also be used in home care and/or outpatient settings.

Medical purposes: This product is intended for use for the aspiration of body ﬂuids. Intended users of the product:

• Legally certiﬁed medical personnel (doctors, nurses and therapists).

• For home treatment or home care under the guidance of medical personnel.

• Users must also be able to understand the operation of the medical device, and the contents of the instruction manual, in general terms.

Intended patients for the product: People who need to remove body ﬂuids (saliva, blood, etc.). Environment: This product is intended for use in the ﬁeld and/or on a vehicle. It may also be used in home care and/or outpatient settings. Expected duration: Duration may vary based on the operating environment. The lifetime of the device is 5 years and that of the collection

vessel and the silicone tubes 1 year or 30 sterilisation cycles. The cannula, manual ﬂow regulator, antibacterial ﬁlter and bag are disposable devices and must therefore be replaced after each application. Frequent use of the product may shorten the duration.

Precautions for use: The warnings and cautions described in the instruction manual must be observed.

IMPORTANT WARNINGS

This is a medical device and must be used by qualified staff. It must be operated as indicated in this user manual. It is important for the operator to read and understand the information on use and maintenance of the unit. If you have any questions, contact your dealer. MICROBIAL CONTAMINATION: in case of illnesses with a risk of infection or microbial contamination, the accessories should be thoroughly cleaned and sterilised after each use.

The manufacturer has made every effort to ensure that all its products are of the highest quality and safe. Nevertheless, as with all electrical devices, make sure to follow all basic safety standards.

• Children and persons who are not self-sufficient may only use the device under the strict supervision of a responsible adult who has read this manual. Some device components are small enough for children to swallow. Therefore, keep the device out of reach of children.

• Due to their lengths, the power cord and connection tube could create a strangulation hazard.

• The device must always be used by specifically trained staff, who have read this manual.

• This device should only be used for its intended purpose as an aspirator for home and clinical use. Any other use shall be considered inappropriate and therefore hazardous. The manufacturer shall not be liable for any consequences arising from inappropriate use.

• Never use power adapters with voltages other than the voltage shown on the power supply unit (rating plate). Keep the power cord away from hot surfaces.

• The device should not be used in the presence of flammable anaesthetic mixtures with air, oxygen or nitrous oxide.

• Never handle the power supply unit with wet hands. Never use the device (with power supply unit connected) close to water.

• Never immerse the device in any liquid. Do not wet the device. If the device falls into water, disconnect the power supply from the power outlet before recovering the device.

• Do not use the device if the plug or power cord are worn or wet (immediately send it back to your dealer).

• Only authorised personnel may perform maintenance and/or repair work on this device. Unauthorised repairs void the warranty.

• Ensure that all connections and vessel closing are performed carefully to avoid suction losses.

• Do not overturn the vessel while connected to the device in operation, as liquid may be sucked inside the device, causing pump damage. If this occurs, immediately switch the aspirator off. Then drain and clean/sterilise the vessel. Send the device to your dealer.

• Tripping of the safety device stops the suction. Drain the vessel and perform the cleaning/sterilisation operations.

• The disposable cannula and manual regulator are disposable sterile products. They must be replaced after every use.

• Check the expiry date of the cannula on the original packaging. Check the integrity of the sterile packaging. If expired or damaged,

INTENDED USE

replace it immediately.

• The disposable antibacterial filter must be replaced after every use.

• Never use the battery charger with other devices or for uses other than that described in this manual. Never use the MINIASPEED BATTERY PRO with other power supply units.

• The cigarette lighter plug cord has a safety fuse, which can be inspected in case of malfunction.

• Use of the device in ambient conditions other than those specified in the manual may seriously impair its safety and technical cha racteristics.

• In the event of aspiration without vessel and/or antibacterial filter, or if you suspect that solid or liquid substances have entered the aspiration circuit, send the device to customer service.

• Always place the device in a vertical position on an unobstructed, stable and flat surface before use.

Before each use, ensure that all accessories are perfectly clean according to the instructions in the “CLEANING AND DISINFECTION

INSTRUCTIONS FOR USE

OPERATIONS” section.

1. Operation using cigarette lighter plug cord:

1.1 For use on vehicles, connect the power cord (11.) to the socket on the device (1a.).

1.2 Check the charge status of the vehicle’s battery before using the device.

1.3 Connect the device as shown in the connection diagram on page 2.

1.4 Use the vacuum regulator (1d.) to set the level of vacuum required (bar/KPa). Turn the knob clockwise, in the “+” direction, to obtain

a stronger vacuum or anticlockwise, in the “-“ direction, for a weaker vacuum. These levels may be read on the vacuum gauge (1f).

Important: the vacuum values on the control decal are purely for guidance. Always refer to the vacuum gauge rea

ding.

1.5 Start the device using the “ON-OFF” switch (1c.) (solid green indicator light on).

1.6 After use, switch off the device, disconnect the cigarette lighter plug cord (11.) and clean the device as described in the “CLEANING

AND DISINFECTION PROCEDURES” section.

1.7 If the cigarette lighter plug fuse blows, replace it with a delayed 6.3 A-250 V fuse, size Ø 6.3 x 30 mm, by unscrewing the tip of the cigarette lighter plug.

2. Operation using the battery and/or multi-voltage power supply unit:

2.1 The device is supplied with the battery partially charged. We therefore recommend charging it before use.

2.2 Charge the battery, with the device off, by connecting the multi-voltage power supply unit (10.) to the device’s socket (1a.) and to

mains power using the power cord (9.). Maximum charging time 6 hours, which provides autonomy of about 45 minutes.

2.3 Operation with internal battery only:

Start the device using the “ON-OFF” switch (1c.) (solid green indicator light on). If the green light goes out during use (1b), and the

yellow light comes on, there will be about 10 minutes of battery charge left (reserve level). Then, terminate use as soon as possible. If use cannot be stopped, continue until the red indicator light comes on (battery flat). If this occurs, do not use the device for more than 3 minutes to avoid damaging the battery. To continue using the device with the battery flat (red light on), connect the multi-voltage power supply unit (10.) (as described in point 2.2). After use, turn the switch (1c.) to “O” (OFF) and leave the power supply (10.) connected to the device’s socket (1a.) to charge the battery. The power supply (10.) should be left connected when the device is not in use to ensure an optimal battery charge level.

2.4 For aspiration procedures, see points 1.3, 1.4 and 1.5.

N.B.: when the battery power drops below a set level the aspirator shuts down to avoid damage to the battery. If abso

lutely necessary, the user can restart the aspirator for 1 minute by pressing the ON/OFF button again.

2.5 After use, switch off the device, disconnect the power cord (9.) from the mains socket and disconnect the power supply unit (10.) from

the device. Perform the cleaning operations as described in the “CLEANING AND DISINFECTION PROCEDURES” section.

2.6 Use only genuine 3A accessories.

3. Secretion collection vessel – 1000ml

The 1000 ml collection bottle (2.) supplied with the aspirator can be used in two ways: as a collection vessel which can be sterilised as

shown in figure 1 or as a collection vessel with disposable bag (8.) as illustrated in figure 2.

3.1 Sterilisable secretion vessel (2.):

The secretion vessel set consists of an overflow valve, a vessel in clear material (polycarbonate) and a blue plug (2a.). Fit the antibacterial

filter (3.) straight into the plug (2a.); it will only fit into the hole marked VACUUM/VUOTO. The antibacterial filter also protects the aspiration circuit from any contaminating agents sucked in during use. Do not use the aspirator without the antibacterial filter,

because from a bacteriological point of view, it becomes dangerous for the patient. Keep the device vertical to allow the overflow to function correctly.

All the components of the vessel can be sterilised using a conventional system in an autoclave at a temperature of 121°C, or by boiling

for 10 minutes. We recommend replacing the complete vessel at every 30 sterilisation cycles. Do not overturn the vessel during use, in order to prevent the intervention of the non-return valve (2b/2c/2d); should this occur, switch the aspirator off and detach the tube connected to the antibacterial filter. Never use the aspirator without the secretion collection vessel and/or without the antibacterial filter.

3.1.1 Connection: connect one end of the short, sterilisable silicon tube (4.) to the antibacterial filter connector (3.) and insert this latter into the “VACUUM” hole of the blue top (2a.); connect the other end to the “INLET” connector (1e.) of the aspirator. Connect one end of the long sterilisable silicon tube (5.) to the PATIENT/PAZIENTE” connector of the blue top (2a.); to the other end, connect the disposable, sterile manual regulator (6.) and connect the disposable, sterile cannula (7.) to this latter.

3.2 Secretion collection vessel with single use bag (8.):

The aspirator can be used with the 1000 cc re-usable transparent secretion collection vessel (2.) and with the single use bag (8.)

supplied. In this case the antibacterial filter is integrated in the single-use bag, therefore the antibacterial filter (3.) and the blue lid with the valve (2a.) should not be used. The filter embedded in the bag, also prevents the reflux of the liquids sucked towards the aspirator when it is full, or when it is inadvertently turned over. In this case to restore the device to normal operation, the single use bag shall be replaced. For the cleaning and disinfecting operations of the tubes (4. and 5.) and vessel (2.), sterilise the single parts in autoclave at a maximum temperature of 121°C, or by boiling them for 10 minutes. The bag is single use and it MUST be

replaced after each use. The bag must be completely inserted in the vessel in order to prevent any vacuum losses.

N.B.: maximum disposable bag usage vacuum: -0.75 bar (75 kPa).

3.2.1 Connection: connect one end of the short sterilisable silicon tube (4.) to the yellow rubber holder (VACUUM) of the bag (8.)

and the other end to the “INLET” input (1e.) of the aspirator. Connect one end of the long sterilisable silicon tube (5.) to the red rubber holder (PATIENT) of the bag (8.) and connect the sterile single-use manual regulator (6.) and the single-use sterile cannula (7.) to the other end.

N.B.: only use the single use bags supplied by 3A - Code 3AC461.

N.B.: If using chemical disinfectants, carefully follow the manufacturer’s instructions.

• The cannula and the manual regulator are sterile, disposable products and must be replaced after every application.

• The disposable antibacterial filter must be replaced after every use.

• Never wash the device under running water or by immersion. Clean the outside of the device using only a cloth dampened with a nonabrasive detergent.

TECHNICAL SPECIFICATIONS OF THE ACCESSORIES:

• Disposable antibacterial filter - code 3A1385

• 1000 ml collection vessel in polycarbonate, complete with cap - code 3AC286

• Silicone tube Ø 6 x 12 mm L 240 mm - code 3A476

• Silicone tube Ø 6 x 12 mm L 1300 mm - code 3A561

• Disposable sterile cannula CH14 - code 3A4167

• Disposable manual regulator - code 3A560

• 1 litre disposable bag - code 3AC461

PROBLEMS, CAUSES and SOLUTIONS

PROBLEMS POSSIBLE CAUSES SOLUTIONS

CLEANING AND DISINFECTION PROCEDURES

Excessive noise.

The unit switches on but does not aspirate

The vacuum rate cannot be regulated

When the appliance is switched on, the protection fuse always trips

The vacuum gauge does not work Liquid penetrating the pneumatic circuit. Send to the assistance circuit

Damaged pump or blockages in the internal aspiration circuit

- Damaged pump

- Vacuum regulator fully open. Connection tubes disconnected and/or badly connected, broken connection tubes. Container not in a vertical position, full, or defective overflow valve. Possible blockage of the hydraulic circuit inside the unit.

Damage to the internal hydraulic system or blockage of the connection tubes to the aspiration unit.

Pump probably damaged or in shortcircuit. Send to the assistance circuit

Send to the assistance circuit

- Send to the assistance circuit.

- Check the position of the vacuum regulator. Check the connections and the integrity of the tubes. Position the container in a vertical position, check the overflow valve (blocked) and/or replace the silicon tubes.

Send to the assistance circuit

Note: if you experience faults or malfunctioning problems different to those listed above, always and exclusively contact authorised assistance centres.

Electric two-cylinder piston compressor with lifetime lubrication. Metal casing with epoxy powder coating

TECHNICAL SPECIFICATIONS

Risk class under Directive 93/42/EEC: IIa Suction class: High vacuum / Low flow Voltage: 12VDC 45 W Power consumption: 3.75A Adjustable vacuum level: from 0 to -0.85 bar (-85 KPa) Vacuum gauge precision class: 2.5% according to UNI EN 837 Air flow rate: 28 L/min operating without restrictions +/- 10% Temporary use: maximum 45 minutes Dimensions: 37 (length) x 10 (width) x 24 (height) cm Weight: 5.8 kg approx. Noise level: 58 dBA approx.

Multi-voltage switching battery charger: PRI: 100-240V~ 50-60Hz SEC: 14V DC 4.29 A

Internal battery: 12VDC 4.5 Ah lead, hermetic

Battery charge duration: 45 minutes at maximum suction power

Cigarette lighter plug cord fuse: F6.3 A-250 V, delayed; dimensions Ø 6.3 x 30 mm

Operating conditions: Temperature: min. 0°C max. 40°C – Air humidity: min 10% maximum 95%

Storage conditions: Temperature: min. -10°C max. 50°C – Air humidity: min. 10% max. 95%

Atmospheric pressure for operation/storage: min. 690 hPa - max. 1060 hPa

Type BF device

SYMBOLS USED

Class II device

It is compulsory to carefully read the instructions before using this device

Switch on

Switch off (or battery on charge)

Direct current

Alternating current

Never use the device when taking a bath or a shower

The device contains a sealed lead-acid battery. It must be disposed of in accordance with current regulations on the disposal of toxic-harmful waste.

The device’s casing is protected against solids 12.5 mm or more in diameter, against vertically falling drops of water and against

IP21

finger access to hazardous parts.

Ethylene oxide sterilisation

Disposable

3A HEALTH CARE S.r.l.

Via Marziale Cerutti, 90F/G 25017 Lonato del Garda (BS) - ITALY

Compliant with Medical Devices Directive 93/42/EEC

Electromagnetic Compatibility

Compliance levels according to EN 60601-1-2:2015 standard

- ESD immunity: 15 kV air, 8 kV contact (EN 61000-4-2)

- Burst immunity: 2 kV/100 kHz (EN 61000-4-4)

- Surge immunity (EN 61000-4-5): 1 kV common mode /2 kV differential mode

- Magnetic field (EN 61000-4-8): 30 A/m

- Immunity to rf currents in the 150 kHz-80 MHz range (EN 61000-4-6) 3 V modulation 80% 1 kHz

- RF emissions, CISPR 11: Class B

- Harmonics emissions, EN 61000-3-2: Class A

Rf ﬁeld immunity (EN 61000-4-3):

Field (V/m) Frequency Modulation

3 80MHz 2700MHz 1kHz AM 80% 27 380MHz 390MHz 18Hz PM 50% 28 430MHz 470MHz 18Hz PM 50%

9 704MHz 787MHz 217Hz PM 50% 28 800MHz 960MHz 18Hz PM 50% 28 1700MHz 1990MHz 217Hz PM 50% 28 2400MHz 2570MHz 217Hz PM 50%

9 5100MHz 5800MHz 217Hz PM 50%

Warnings:

Although compliant with the EN 60601-1-2 standard, the MINIASPEED BATTERY PRO medical device may interfere with other devices in the vicinity. The device must not be used in proximity to or stacked on top of other equipment. Install the device well away from other equipment that emits high frequencies (short waves, microwaves, electric scalpels, cell phones). The device is intended for use in an electromagnetic environment in which radiated RF disturbances are under control. The customer or user can help prevent electromagnetic interference by maintaining a minimum distances between mobile and portable RF communication equipment (transmitters) and the medical device as recommended below, according to the maximum output power of the radio communication equipment.

Rated maximum

output power

of transmitter

(W)

from 150 kHz to 80 MHz

Separation distance (m) in relation to transmitter frequency

d = 1.2 √P

from 80 MHz to 800 MHz

d = 1.2 √P

from 800 MHz to 2.5 GHz

d = 2.3 √P

0,01 0,12 0,12 0,23

0,1 0,38 0,38 0,73

1 1,2 1,2 2,3

10 3,8 3,8 7,3

100 12 12 23

For transmitters with rated maximum output power not listed above, the recommended separation distance d in metres (m) may be determined using the equation adopted for the transmitter frequency, where P is the maximum rated output power of the transmitter in Watts (W) stated by the transmitter manufacturer.

Notes:

(1) At 80 MHz and 800 MHz the highest frequency range applies. (2) These guidelines might not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

PROCEDURA DI SMALTIMENTO (Dir.2012/19/Ue-RAEE) Il simbolo posto sul fondo dell’apparecchio indica la raccolta separata delle apparecchiature

elettriche ed elettroniche. Al termine della vita utile dell’apparecchio, non smaltirlo come rifiuto municipale solido misto ma smaltirlo presso un centro di raccolta specifico situato nella vostra zona oppure riconsegnarlo al distributore all’atto dell’acquisto di un nuovo apparecchio dello stesso tipo ed adibito alle stesse funzioni. Questa procedura di raccolta separata delle apparecchiature elettriche ed elettroniche viene effettuata in visione di una politica ambientale comunitaria con obiettivi di salvaguadia, tutela e miglioramento della qualità dell’ambiente e per evitare effetti potenziali sulla salute umana dovuti alla presenza di sostanze pericolose in queste apparecchiature o ad un uso improprio delle stesse o di parti di es se. Attenzione! Uno smaltimento non corretto di apparecchiature elettriche ed elettroniche potrebbe comportare sanzioni.

PROCEDURA DI SMALTIMENTO (Dir.2012/19/Ue-RAEE) Il simbolo posto sul fondo dell’apparecchio indica la raccolta separata delle apparecchiature elettriche ed elettroniche. Al termine della vita utile dell’apparecchio, non smaltirlo come rifiuto municipale solido misto ma smaltirlo presso un centro di raccolta specifico situato nella vostra zona oppure riconsegnarlo al distributore all’atto dell’acquisto di un nuovo apparecchio dello stesso tipo ed adibito alle stesse funzioni. Questa procedura di raccolta separata delle apparecchiature elettriche ed elettroniche viene effettuata in visione di una politica ambientale comunitaria con obiettivi di salvaguadia, tutela e miglioramento della qualità dell’ambiente e per evitare effetti potenziali sulla salute umana dovuti alla presenza di sostanze pericolose in queste apparecchiature o ad un uso improprio delle stesse o di parti di es se. Attenzione! Uno smaltimento non corretto di apparecchiature elettriche ed elettroniche potrebbe comportare sanzioni.

ENTSORGUNGSVERFAHREN (RICHTLINIE 2012/19/Ue-Weee) Das Symbol auf dem Boden des Geräts gibt die getrennte Müllsammlung der elektrischen und elektronischen Ausrüstungen an. Am Ende der Lebensdauer vom Gerät es nicht als gemischter fester Gemeindenabfall, sondern es bei einem spezifischen Müllsammlungszentrum in Ihrem Gebiet entsorgen oder es dem Händler zurückgeben, wenn Sie ein neues Gerät desselben Typ mit denselben Funktionen kaufen. Diese Prozedur getrennter Müllsammlung der elektrischen und elektronischen Ausrüstungen wird im Hinblick auf eine zukünftige gemeinsame europäische Umweltschutzpolitik vorgenommen, welche darauf zielen wird, die Umwelt zu schützen und sichern, als auch die Umweltqualität zu verbessern und potentielle Wirkungen auf die menschliche Gesundheit wegen der Anwesenheit von gefährlichen Stoffen in diesen Vorrichtungen oder Missbrauch derselben oder von Teilen derselben zu vermeiden. Vorsicht! Die fehlerhafte Entsorgung von elektrischen und elektronischen Vorrichtungen könnte Sanktionen mit sich bringen.

DISPOSAL PROCEDURE (Dir. 2012/19/Ue-WEEE) The symbol on the bottom of the device indicates the separated collection of electric and electronic

ENTSORGUNGSVERFAHREN (RICHTLINIE 2012/19/Ue-Weee) Das Symbol auf dem Boden des Geräts gibt die getrennte Müllsammlung der elektrischen

equipment. At the end of life of the device, do not dispose it as mixed solid municipal waste, but dispose it referring to a sp ecific collection centre

und elektronischen Ausrüstungen an. Am Ende der Lebensdauer vom Gerät es nicht als gemischter fester Gemeindenabfall, sondern es bei einem located in your area or returning it to the distributor, when buying a new device of the same type to be used with the same functions. This procedure

spezifischen Müllsammlungszentrum in Ihrem Gebiet entsorgen oder es dem Händler zurückgeben, wenn Sie ein neues Gerät desselben Typ mit of separated collection of electric and electronic devices is carried out forecasting a European environmental policy aiming at safeguarding, protecting

denselben Funktionen kaufen. Diese Prozedur getrennter Müllsammlung der elektrischen und elektronischen Ausrüstungen wird im Hinblick auf eine and improving environment quality, as well as avoiding potential effects on human health due to the presence of hazardous substances in such equipment

zukünftige gemeinsame europäische Umweltschutzpolitik vorgenommen, welche darauf zielen wird, die Umwelt zu schützen und sichern, als auch die or to an improper use of the same or of parts of the same. Caution! The wrong disposal of electric and electronic equipment may involve sanctions.

Umweltqualität zu verbessern und potentielle Wirkungen auf die menschliche Gesundheit wegen der Anwesenheit von gefährlichen Stoffen in diesen Vorrichtungen oder Missbrauch derselben oder von Teilen derselben zu vermeiden. Vorsicht! Die fehlerhafte Entsorgung von elektrischen und elektronischen PROCÉDURE D’ÉLIMINATION (Dir. 2012/19/Ue-WEEE) Le symbole placé sur le fond de l’appareil indique la récolte séparée des appareils électriques

Vorrichtungen könnte Sanktionen mit sich bringen. et électroniques. A la fin de la vie utile de l’appareil, il ne faut pas l’éliminer comme déchet municipal solide mixte; il faut l’éliminer chez un centre de récolte spécifique situé dans votre zone ou bien le rendre au distributeur au moment de l’achat d’un nouveau appareil du même type et prévu pour les

DISPOSAL PROCEDURE (Dir. 2012/19/Ue-WEEE) The symbol on the bottom of the device indicates the separated collection of electric and electronic mêmes fonctions. Cette procédure de récolte séparée des appareils électriques et électroniques se réalise dans une vision d’une politique de sauvegarde,

equipment. At the end of life of the device, do not dispose it as mixed solid municipal waste, but dispose it referring to a sp ecific collection centre protection et amélioration de la qualité de l’environnement et pour éviter des effets potentiels sur la santé humaine dus à la présence de substances

located in your area or returning it to the distributor, when buying a new device of the same type to be used with the same functions. This procedure dangereuses dans ces appareils ou bien à un emploi non autorisé d’elles ou de leurs parties. Attention! Une élimination incorrecte des appareils

of separated collection of electric and electronic devices is carried out forecasting a European environmental policy aiming at safeguarding, protecting électriques pourrait impliquer des pénalités.

and improving environment quality, as well as avoiding potential effects on human health due to the presence of hazardous substances in such equipment or to an improper use of the same or of parts of the same. Caution! The wrong disposal of electric and electronic equipment may involve sanctions. ENTSORGUNGSVERFAHREN (RICHTLINIE 2012/19/Ue-Weee) Das Symbol auf dem Boden des Geräts gibt die getrennte Müllsammlung der elektrischen und elektronischen Ausrüstungen an. Am Ende der Lebensdauer vom Gerät es nicht als gemischter fester Gemeindenabfall, sondern es bei einem

PROCÉDURE D’ÉLIMINATION (Dir. 2012/19/Ue-WEEE) Le symbole placé sur le fond de l’appareil indique la récolte séparée des appareils électriques spezifischen Müllsammlungszentrum in Ihrem Gebiet entsorgen oder es dem Händler zurückgeben, wenn Sie ein neues Gerät desselben Typ mit

et électroniques. A la fin de la vie utile de l’appareil, il ne faut pas l’éliminer comme déchet municipal solide mixte; il faut l’éliminer chez un centre de denselben Funktionen kaufen. Diese Prozedur getrennter Müllsammlung der elektrischen und elektronischen Ausrüstungen wird im Hinblick auf eine

récolte spécifique situé dans votre zone ou bien le rendre au distributeur au moment de l’achat d’un nouveau appareil du même type et prévu pour les zukünftige gemeinsame europäische Umweltschutzpolitik vorgenommen, welche darauf zielen wird, die Umwelt zu schützen und sichern, als auch die

mêmes fonctions. Cette procédure de récolte séparée des appareils électriques et électroniques se réalise dans une vision d’une politique de sauvegarde, Umweltqualität zu verbessern und potentielle Wirkungen auf die menschliche Gesundheit wegen der Anwesenheit von gefährlichen Stoffen in diesen

protection et amélioration de la qualité de l’environnement et pour éviter des effets potentiels sur la santé humaine dus à la présence de substances Vorrichtungen oder Missbrauch derselben oder von Teilen derselben zu vermeiden. Vorsicht! Die fehlerhafte Entsorgung von elektrischen und elektronischen

dangereuses dans ces appareils ou bien à un emploi non autorisé d’elles ou de leurs parties. Attention! Une élimination incorrecte des appareils Vorrichtungen könnte Sanktionen mit sich bringen.

électriques pourrait impliquer des pénalités.

PROCEDIMIENTO DE ELIMINACIÓN (Dir.2012/19/Ue-RAEE) El símbolo colocado en el fondo del aparato indica la recogida separada de los equipos eléctricos y electrónicos. Al término de la vida útil del aparato, no eliminar como residuo municipal sólido mixto sino eliminarlo en un centro de recogida específico colocado en vuestra zona o entregarlo al distribuidor a la hora de comprar un nuevo aparato del mismo tipo y destinado a las mismas funciones. Este procedimiento de recogida separada de los equipos eléctricos y electrónicos se realiza con el propósito de una política del medioambiente comunitaria con objetivos de salvaguardia, defensa y mejoramiento de la calidad del medioambiente y para evitar efectos potenciales en la salud de los seres humanos debido a la presencia de sustancias peligrosas dentro de estos equipos o a un uso inapropiado de los mismos o de algunas de sus partes. Cuidado! Una eliminación no correcta de equipos eléctricos y electrónicos podría conllevar sanciones.

3A HEALTH CARE S.r.l.

Via Marziale Cerutti, 90F/G - 25017 Lonato del Garda (BS) - Italy

tel. +39 030 9133177 - fax +39 030 9919114

e-mail: mail@3-a.it - www.3-a.it

3A3993 rev. 02 - 11/2021

3A3992 rev. 00 - 02/2018

Gima MINI ASPEED BATTERY PRO User guide

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