3A HEALTH CARE MINIASPEED Battery Evo Plus Instruction Manual

3A HEALTH CARE MINIASPEED Battery Evo Plus

Product Information

The MINIASPEED Battery Evo Plus is a medical device designed for use by qualified staff. It is equipped with various features and accessories to facilitate efficient and safe operation.

1. Vessel: The device includes a 1000 ml vessel made of polycarbonate with serigraph for collection purposes.

2. Vessel Plug: A vessel plug is provided to securely close the collection vessel.

3. Protection Device: This device ensures the safety of the operator during usage.

4. ON-OFF Button: The button is used to power on or off the device.

5. Vacuum Regulator: This feature allows the adjustment of vacuum pressure.

6. Vacuum Gauge: The gauge displays the level of vacuum pressure.

7. Multi-voltage Power Supply Unit and Battery Charger
   

8. Socket: This allows the device to be powered using a suitable power supply or charged using the provided battery charger.

9. Silicon Tube: A 24 cm silicone tube is included for connecting the device to the collection vessel or other accessories.

10. Antibacterial Filter: The filter helps prevent bacterial contamination during usage.

11. Working Light: A lamp is provided for improved visibility during operation.

12. Light-O-OFF Button: This button controls the working light.

13. Accessory Compartment: A storage compartment is available for keeping additional accessories.

14. Ambulance Mounting Bracket: The device includes a bracket for secure mounting in an ambulance.

15. Bag with Shoulder Strap: A bag with a shoulder strap is provided for easy transportation of the device.

16. Disposable Manual Regulator: This regulator is designed for single use and can be disposed of after each use.

17. Power Supply Cord: The cord is used to connect the device to a power source.

18. Disposable Sterile Cannula: A sterile cannula is included for medical procedures.

19. Permanent Ambulance Mounting Bracket: This bracket allows for a fixed installation in an ambulance.

Product Usage Instructions

1. Ensure that the device is operated by qualified staff only.
2. Read and understand the user instruction manual before using the device.
3. If you have any questions or concerns, contact your stockist for assistance.
4. In cases where there is a risk of infection or microbial contamination, thoroughly clean and sterilize the accessories after each use.
5. To use the device, follow these steps:
   • Connect the appropriate power supply or ensure that the battery is fully charged.
   • Attach the collection vessel securely to the device using the vessel plug.
   • Adjust the vacuum pressure using the vacuum regulator as needed.
   • Power on the device using the ON-OFF button.
   • Monitor the vacuum pressure level on the vacuum gauge.
   • If required, use the working light for improved visibility during operation.
   • After usage, power off the device and disconnect the power supply or recharge the battery if necessary.
   • Clean and sterilize the collection vessel and other accessories according to the provided instructions.
   • Store the device and accessories properly in the accessory compartment or bag for future use.
6. Follow all safety precautions and guidelines provided in the user instruction manual to ensure safe and effective usage of the device.

ACCESSORIES

1. 1000 ml Vessel
2. Vessel plug
3. Protection device
4. ON-OFF button
5. Vacuum regulator
6. Vacuum gauge
7. Multi-voltage power supply unit and battery charger socket
8. 24 cm silicon tube
9. Antibacterial filter
10. Working light
11. Light ON-OFF button
12. Accessory compartment
13. Ambulance mounting bracket Bag with shoulder strap
14. Disposable manual regulator
15. Multi-voltage power supply unit
16. Power supply cord
17. Disposable sterile cannula
18. Permanent ambulance mounting bracket

DESCRIPTION OF 1000 ml vessel

1.  1000 ml collection vessel with serigraph, made of sterilizable polycarbonate
2. Sterilizable polypropylene top
3. Sterilizable polypropylene float guide
4. Sterilizable polypropylene float body
5. Sterilizable rubber valve
6. Antibacterial filter
7. Sterilizable silicon tube Ø 6×12 mm – length 24 cm
8. Sterilizable silicon tube Ø 6×12 mm – length 130 cm
9. Disposable bag
10. Disposable sterile cannula
11. Disposable sterile manual regulator

DESCRIZIONE FUNZIONAMENTO LED

1. Flashing red LED: the battery is no longer capable of supplying maximum charge duration; replace it.
2. Red Led permanently on: the battery is flat, use the appliance for a maximum of 3 minutes and re-charge the battery
3. Yellow Led permanently on: the battery is in reserve (about 10 minutes operating time left); recharge it if possible.
4. Green Led permanently on appliance operating, battery charged.
5. Green Led flashing: battery under charge.

DESCRIPTION OF AMBULANCE MOUNTING

DESCRIPTION OF PROCEDURE FOR MOUNTING BRACKET IN AMBULANCE\

The MINIASPEED BATTERY EVO PLUS aspirator, specific for secretion removal, is a portable professional device suitable for use in ambulances, in homes, and in clinics.

It has a vacuum regulator, a vacuum gauge, and a 1000 ml container with a protection device to prevent liquid from entering the suction pump, which cuts off the aspiration flow.

It has lifetime lubrication and is easy to handle, simple to use, reliable, strong, and silent. This model has a 12 V rechargeable battery; when connected to the ambulance mounting bracket it not only operates on the ambulance’s battery but also recharges.

The MINIASPEED BATTERY EVO PLUS
aspirator has the following accessories: a 1000 ml container with a protection device, a power supply cord with a multi-voltage power supply unit, 24 cm long sterilizable silicone connection tube, 130 cm long sterilizable silicone connection tube, a sterile, disposable cannula, a sterile, disposable manual flow regulator, disposable bag and disposable antibacterial filter.
N.B.: Only use genuine accessories supplied by 3A Health Care; the accessories supplied with the device by the manufacturer 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 the use of accessories other than those supplied.

INTENDED USE
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 an ambulance. However, 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 instruction manual. It is important for the operator to read and understand the information on the use and maintenance of the unit. If you have any questions, contact your stockist

MICROBIAL CONTAMINATION : in the case of illnesses with a risk of infection or microbial contamination, the accessories should be thoroughly cleaned and sterilized after each use.
The manufacturer has made every effort to ensure that all its products are of the highest quality and are reliable.

• Nevertheless, as for all electrical appliances, fundamental safety standards must be observed:
• Children and persons who are not self-sufficient may only use the unit under the strict supervision of a responsible adult who has read this manual.
• The device must always be used by specifically trained staff who have read this manual.
• Never use adapters for supply voltages different to the voltage shown on the data plate on the back of the unit. Keep the cord away from hot surfaces.
• The unit should not be used in the presence of inflammable anesthetic mixtures with air, oxygen, or nitrous oxide.
• Never handle the supply cord plug with wet hands or use the unit when taking a bath or a shower.
• Never leave the unit close to water, do not submerge it in any liquids.
• If by chance it falls into water, pull the plug out of the socket immediately before recovering it. Do not use the unit if the plug or supply cord is worn or wet (send it immediately to your stockist).
• Although the device is protected against sprays of water, do not use it in the rain.
• Only authorized personnel may perform maintenance and/or repair work. Unauthorized repairs annul the guarantee.
• Ensure that the connections and container closing are performed carefully to prevent suction losses.
• Do not tip the container over while connected to the unit when operating, as the liquid may be sucked inside the appliance causing pump damage.
• If this happens, switch the aspirator off immediately and empty and clean the container. Send the appliance to your stockist.
• When the protection device intervenes aspiration is interrupted; empty the container and perform the cleaning operations.
• The cannula and the manual control of the aspirated flow are sterile, disposable products: They must be replaced after every application.
• Check the use-by-date on the original packaging of the cannula and check the integrity of the sterile packaging.
• If expired and/or deteriorated, replace it. The disposable antibacterial filter must be replaced after every application.
• Never use the battery charger with other appliances or for uses other than that established by this manual.
• Never use MINIASPEED BATTERY EVO PLUS with other power supply units.
• In view of their length, the power cord and connection hose could constitute a strangulation hazard.
• Use of the device in ambient conditions other than those specified in the manual may seriously impair its safety and technical characteristics.
• In the event of aspiration without the container and/or antibacterial filter, or if it is suspected that substances have entered the aspiration circuit, contact your stockist at once.
• Never modify the device’s mounting bracket or the bracket installed in the ambulance as this may impair the safety of both the device and its installation environment.
• Always use the device in the vertical position on an unobstructed, stable, flat surface.

USE INSTRUCTIONS

Each time before use, ensure that all the accessories are perfectly clean according to the instructions indicated in the “CLEANING AND DISINFECTION OPERATIONS”.

OPERATION WITH MULTI-VOLTAGE POWER SUPPLY UNIT

• Check the charge level of the ambulance’s battery before using the device
• For use outside the ambulance (i.e. not fixed to the bracket [19]) with the internal battery flat or not fully charged, connect the multi-voltage power supply (16) to the socket on the device (7), and connect the cord (17) to a mains power socket.
• Connect the appliance as indicated in Figure 1 (page 1).
• Start the appliance by placing the switch in the “I” (ON) position (4) (green pilot light on).
• The vacuum regulator (5) can be used to set the level of vacuum required (bar/KPa). Turn the knob clockwise, in the “+” direction, to obtain a higher vacuum or anticlockwise, in the “-“ direction, for a lower vacuum; these values are read on the vacuum gauge (6),
• Important: the vacuum values on the control decal are purely for guidance; always refer to the vacuum gauge reading.
• After the application, switch off the device, remove the supply cord (17) from the main socket, and disconnect the power supply unit (16) from the device. Perform the cleaning operations as described in the “CLEANING AND DISINFECTION” paragraph.

OPERATION WITH BATTERY AND BATTERY CHARGER WITH MULTI-VOLTAGE POWER SUPPLY UNIT

The device is supplied with the battery partially charged. We therefore recommend charging it before use. To charge the battery, with the device switched off connect the multi-voltage power supply unit (16) to the device’s socket (7) and to the mains power supply by means of the cord (17). Charging time: about 4 hours. Charge duration: about 40/45 minutes at maximum suction power.

Operation with internal battery only
Switch the device on by pressing the “ON-OFF button (4) (green light comes on). If the green light goes out during use, and the yellow light comes on, there is about 10/15 minutes of battery charge left (reserve level). Therefore: terminate the application if possible. If the application cannot be terminated, it can be continued until the red (battery flat) light comes on, but if this occurs do not use the appliance for more than 3 minutes to avoid damaging the battery. To continue the application with the battery flat (red light on), connect the multi-voltage power supply unit (16) (as described in point 2.2). At the end of the application, switch the device off by pressing the button (4). Connect the power supply unit (16) to charge the battery (as described in point 2.2). If the device is not in use and is not connected to the bracket (19) in the ambulance, the power supply unit should be left connected (16) to ensure that the battery is always charged to the optimal level.

For aspiration procedures see points 1.3; 1.4; 1.5
N.B.: when the battery power drops below a set level the aspirator shuts down to avoid damage to the battery. If absolutely necessary, the user can restart the aspirator for 1 minute by pressing the ON/OFF button again.

OPERATION WITH THE DEVICE INSTALLED IN THE AMBULANCE

• The device can also operate connected to the ambulance mounting bracket (19).
• With the device connected to the bracket (19), there is no limit to patient treatment time because the device is powered directly by the ambulance battery.
• The device’s battery is charged by leaving it connected to the ambulance mounting bracket (19).
• The device’s battery is also charged while treatment is in progress (with the device connected to the ambulance mounting bracket).
• For aspiration procedures see points 1.3; 1.4; 1.5.

SECRETION COLLECTION VESSEL – 1000 ml
The 1000 ml collection bottle supplied with the aspirator can be used in two ways: as a collection vessel which can be sterilized as shown in Figure 3a or as a collection vessel with a disposable bag (9) as illustrated in Figure 3b. Sterilizable secretion vessel (1): the secretion vessel set consists of an overflow valve, a vessel (1) in clear material (polycarbonate), and a blue plug (2). Fit the antibacterial filter (6) straight into the plug (2); it will only fit into the hole marked VACUUM/VUOTO, which is outlined in yellow. 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 sterilized 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 every 30 sterilization cycles. Do not overturn the vessel during use, in order to prevent the intervention of the nonreturn valve (3-4-5); 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.

Connection: connect one end of the short, sterilizable silicon tube (7) to the antibacterial filter connector (6) and insert this latter into the “VACUUM” hole of the blue top (2); connect the other end to the “INLET” connector of the aspirator. Connect one end of the long sterilizable silicon tube (8) to the “PATIENT/PAZIENTE” connector of the blue top (2); to the other end, connect the disposable, sterile manual regulator (11) and connect the disposable, sterile cannula (10) to this latter.

Secretion collection vessel with disposable bag (9). The aspirator can be used with the re-usable 1000 ml. transparent secretion collection vessel (1) and with the disposable bag (9) supplied. In this case, the antibacterial filter is integrated into the disposable bag and therefore the antibacterial filter (6) and blue top with valve (2) are not used. The filter integrated in the bag also performs the function of preventing the return of aspirated liquids to the aspirator.

In this case, to restore device operation, it is necessary to replace the disposable bag. For the cleaning and disinfecting operations of the tubes (7-8) and vessel (1), sterilize the single parts in an autoclave at a maximum temperature of 121° C, or by boiling for 10 minutes. The bag is disposable and must always be replaced after every 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).

Connection: connect one end of the short sterilizable silicon tube (7) to the yellow connector (VACUUM) of the top (photograph 3b) and the other end to the “INLET” connector of the aspirator. Connect one end of the long sterilizable silicon tube to the red connector (PATIENT) and connect the disposable sterile manual regulator (11) and the disposable sterile cannula (10) to the other.
N.B.: only use the disposable bags supplied by 3A – Code 3A1687.

DESCRIPTION OF USE OF WORKING LIGHT

The MINIASPEED BATTERY EVO PLUS is fitted with an LED working light (10) which allows use of the device in dark conditions and/or at night. Press the button (11) to switch on the light, as shown in Figure 5 of page 3; press the button (11) again to switch it off. The light switches off automatically after about 60 minutes. The light is of LED type, so the amount of current it consumes is minimal and it can be used even during treatment; however, it should be switched off whenever it is not required and/or at the end of the treatment

CLEANING AND DISINFECTION OPERATIONS
N.B.: If using chemical disinfectants, follow the manufacturer’s instructions exactly.

• The cannula and the aspirated flow manual command are sterile, disposable products and must be replaced after every application.
• The antibacterial disposable filter must be replaced after every application.
• Never leave the appliance in water or submerged; clean the external casing of the appliance using only a damp cloth with detergent (nonabrasive).

DESCRIPTION OF AMBULANCE MOUNTING / RELEASE SYSTEM

1. Fit the bottom of the bracket fixed to the aspirator into the recess provided in the bottom of the bracket mounted in the ambulance (as shown in Figure 6 of page 3).

2. Keeping the device engaged with the bracket, push it until it engages with the hook in the top of the yellow mobile bracket (as shown in Figure 6a):
   N.B.: to ensure that the device engages correctly, press the mobile bracket, push the device fully down, and release the mobile bracket (as shown in Figure 6b). ALWAYS CHECK THAT THE DEVICE HAS ENGAGED WITH THE BRACKET.

3. To release the device, press the yellow mobile bracket and lift the aspirator up and toward you (as shown in Figure 6c). KEEP A FIRM GRIP ON THE HANDLE OF THE ASPIRATOR WHILE RELEASING IT

DESCRIPTION OF PROCEDURE FOR MOUNTING BRACKET IN AMBULANCE
The ambulance mounting bracket is supplied assembled and complete (as shown in Figure 7):

1. Wall mounting bracket.
2. Mobile bracket.
3. Mobile bracket spring.
4. Block complete with electrical contacts and cord.
5. 2-meter power cord for connecting the ambulance battery.

Mounting the bracket in the ambulance

• The bracket must be installed on the panel inside the ambulance by skilled staff authorized by the vehicle’s constructor/outfitter.
• The fixing points are shown in Figure 7a, Figure 7b and Figure 7c.
• M5 Allen screws (UNI 5931-DIN 912-ISO 4762) should be used since they undergo deceleration testing at 10g as required by the EN 1789 standard.
• Otherwise, screws (with the same mechanical characteristics) having (non-tapered) heads, max. Ø10, and no more than 7 mm in height (including the washer, if fitted) can be used.
• See Figure 7d for the fixing center distances. Wiring connection/polarity
• The bracket is supplied complete with the ambulance battery connection cord (5) (already fitted), which powers the device and charges its battery when it is connected to the bracket.
• Connect the wires to the ambulance following the polarity shown in Figure 7e.
• If the cord is disconnected from the bracket for any reason, reconnect it following the polarity shown in Figure 7f.
• N.B.: Take great care over the polarity (+ and –) because if it is reversed the device’s electronic circuit board and battery will be damaged beyond repair

PROBLEMS, CAUSES AND SOLUTIONS
Note: if you experience faults or malfunctioning problems different to those listed above, always and exclusively contact authorized assistance centers.

– 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.

| –   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.

The vacuum rate cannot be regulated.| Damage to the internal hydraulic system or blockage of the connection tubes to the aspiration unit.| Send to the assistance circuit.
When the appliance is switched on, the protection fuse always trips.| Pump probably damaged or in shortcircuit.| Send to the assistance circuit.
The vacuum gauge does not work.| Liquid penetrating the pneumatic circuit.| Send to the assistance circuit.

SYMBOLS USE

TECHNICAL CHARACTERISTICS

Professional portable medical device for secretion removal, suitable for fixed and transportable use.
Complete with flame retardant ABS V0 casing and piston-cylinder electrical compressor lubricated for life.

• Risk class under Directive 93/42/EEC: IIb
• Suction class: High vacuum / High flow
• Protection level against entry of liquids and solids: IP44
• Voltage: 12VDC
• Absorption: 3A
• Adjustable vacuum level: from 0 to –0.85 bar (-85KPa)
• Vacuum gauge precision class: 2.5% under UNI EN 837
• Airflow: 30 lt/min operating without restrictions +/– 10 %
• Temporary use: max. 45 minutes
• Dimensions: 38 (length) x 13.5 (width) x 26 (Height) cm
• Weight: 4.6 kg approx
• Noise level: 55dBA (1m)
• Multi-voltage switching battery charger: PRI: 100 ÷ 240V~ 50 – 60Hz
• SEC: 14VDC 4.28A
• Internal battery: 12VDC 4Ah Lead, hermetic
• Battery charge duration: 45 minutes at maximum suction power
• Operating conditions:
• Temperature: min. 0° C; max 40° C
• Air humidity: min. 10 %; max 95 %
• Storage conditions:
• Temperature: min. –10° C; max 50° C
• Air humidity: min. 10 %; max 95 % %
• Operating-storage conditions: min. 690 hPa; max 1060 hPa

SYM

BOLS USED

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 EVO PLUS 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 distance 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. For transmitters with rated maximum output power not listed above, the recommended separation distance d in meters (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.

Rated maximum output power of transmitter

(W)

| Separation distance (m) in relation to transmitter frequency
---|---
from 150 kHz to 80 MHz 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.

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.

DISPOSAL PROCEDURE (Dir. 2012/19/Ue-WEEE)
The symbol on the bottom of the device indicates the separate collection of electric and electronic equipment. At the end of the life of the device, do not dispose of it as mixed solid municipal waste, but dispose of it by referring to a specific collection center 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 of separated collection of electric and electronic devices is carried out forecasting a European environmental policy aiming at safeguarding, protecting, 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

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

References

• 3a Health Care – L’ARTE DEL BENESSERE

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