Introduction
Intended Use
Preliminary Remarks
W arnings and Safety Instructions
DANGER, W ARNING, CAUTION, NO TE/A T TENTION ST A TEMENT
Instructions for Use
Cleaning, Sanitization, Disinf ec tion operations
P ower Sourc e Options
LED Explanations
Battery Charging
Battery Replacement
P ower Saving Opera tion
We thank you for pur chasing our Aspirator V7 which is adaptable to your needs. It is v er y important
that the health care worker and/or the patient read and understand the information for use and
maintenance.
Suction unit (Aspirator) V7 can be used to remo ve unwanted uids or inf ectious materials from the
air way or respirat or y suppor t system in health care structures like hospitals and home care .
The de vice generates suction (aspiration) which allows uids to be extracted through connec ting
PVC tubing connec ted to a collection canister which retains the uids until they can be properly
disposed of . Use of the device must be prescribed by a doctor .
Carefully f ollow the recommended operations and procedures outlined in this instruction guide to
ensure proper functioning and maximize the lif e of the device.
This Suction unit (Aspirator) complies with the European regulations and bears the CE mark
“CE 1639” . The quality of the device has been veried and conforms to the provisions of the EC
council directive 93/42/EEC amended by 2007/47/EC (Medical Device Directive), Annex I essential
requirements and applied harmonized standar ds.
EN ISO 10079-1:2015 Medical suction equipment - Part 1: Electr ically power ed suction equipment.
Suction unit (Aspirator) V7 is EMC-test ed in conformity with the requir ements of IEC 60601-1-2 and
can be used in the vicinity of other EMC-tested devices that fulll the requirements as outlined in
the IEC 60601-1-2 standar d. Untest ed HF sources, radio networks or the like can impair the function
of the device and should not be operated in combination with the Aspirator V7. The suction
equipment is not suitable for use in an MRI environment. Please read and obser ve these war ning
and safety instructions befor e operation. These instruc tions for use must be kept with the device
for later r eference. P lease note that these instructions are a general guide for the use of the product.
Medical matters must be addressed by a ph ysician. Rossmax considers himself only responsible for
the eect on BASIC SAFET Y , r eliability and performance of the Aspirat or V7 if it is used in accor dance
with the instructions for use.
Important S afeguards
This is a medical device and must be used b y qualied users. It must be operated as
indicated in this user instruction manual.
Read All Instructions B efore U sing This Device . Save These Instructions.
The manufac turer makes ever y eor t to ensure that ever y product is of the highest quality and
safety ; however , as for any electrical appliances, basic safety regulations must always be observed
in order to av oid harming persons and things.
DANGER: Urgent safety information for hazards that will cause serious injury or death.
W ARNING: Impor tant safety inf ormation for hazards that draws attention to a potential danger .
CAUTION: Indicates correct operating or maintenance procedur es to prevent damage to the
product or other property.
Note/A ttention: I ndicates inf ormation to which users should pay special att ention.
DANGER:
1. The device is intended exclusively for the collection of NON-ammable or NON- corrosive uid
materials in medical applications only . This unit should not be used in the presence of ammable
anaesthetic mixture with air , or with oxygen or nitrous oxide .
2. Do not use outdoors or operate where aerosol (spray) products are being used or wher e oxygen is
being administered in a closed envir onment such as an oxygen reservoir .
3. Do not handle the AC/DC switching adapter plug with wet hands or use the unit when taking
a bath or shower . Never submerge the device in an y liquids.
4. Do not use the unit if the plug or AC adaptor is worn or wet and remove or t ouch the immersed
device. If by chance it falls into water , do not attempt to r emove the device from the water while the
plug is still connected; pull the plug out of the socket and disconnect the mains switch. Br ing the
device to your local distributor or authorized Rossmax service center immediately. Do not attempt
to mak e the device work before it has been thoroughly checked by qualied personnel and/or
authorized Rossmax ser vice center .
5. Do not place or stor e the device where it can fall or be pulled into a tub or sink.
W arning:
1. The medical device must NO T be used in the operating thea ter , for dr ainage or thoracic
drainage and nasogastric suction.
2. Never operate this product if a) it has a damaged cor d or plug , b) it is not work ing pr operly, c) it has
been dropped or damaged, d) it has been dr opped into water .
Immediately return the product to your local distributor or authorized R ossmax ser vice center for
examination and repair .
3. F or use only by medically trained persons who ha ve been adequately trained in suction procedures
and in the use of aspirators.
4. I ncorrect use can cause pain and injury to the patient.
5. Do not star t the machine if you suspec t the presence of explosive or inammable liquids or gases,
water inside the machine or environmental conditions that ar e not within the specied limits.
6. Do not per form any maintenance operations while the device is being used on a patient.
7. Replacement device must always be available if a breakdown of the device f or patients can lead to
a critical situation (e.g. patients with acute dyspnoea or sev ere catarrhal congestion),
8. The patient should be monitored r egularly according to the physicians instructions and facility
guidelines. Objective indications or signs of a possible inf ection or complication must be met
immediately (e.g . fever , pain, redness , increased warmth, swelling or purulent discharge). Non-
obser vance can lead to considerable danger f or the patient. Monitoring the Aspirator V7 f or
operating status is a must.
9. Consult the indications for use and consider risk factors and contraindications before using the
Aspirator V7. F ailure t o read and follow all instructions in this manual prior to use may result in
serious or fatal injur y of the patient.
10. I n the presence of children and non self-sucient individuals , the device must be used under the
close super vision of an adult who has been adequately trained in suction procedures and in the
use of aspirators.
11. Some par ts of the device are small enough to be swallowed by children; keep the device out of
the reach of children.
12. D o not use the provided tubing and A C adaptor for any other purpose than those specied, as
they can cause risk of strangulation. B e particular ly attentive with children and individuals with
disabilities because they ar e often unable to correctly assess risk.
The de vice must be check ed before each use in order to detect malfunctions and / or damage
caused by transport and / or storage and do not connect to power if damage is apparent.
Before each use , the accessories must be carefully inspected to ensure the absence of dust,
incrustation, clots or liquid substances both inside the connecting tubing and the collection canister .
F ur thermore, they must be cleaned f ollowing the instructions rigorously as stated in the "cleaning,
sanitization, disinfection" .
We r ecommend personal use of the accessories, the collection canister , the connecting tubing and
antibacterial lter to prevent risk of contagious inf ection.
1. Assembling procedures
1-1. Connect one end of connecting silicone tubing (Ø8mm,14cm), with the antibacterial lter
marked “IN ” side, to the V ACUUM inlet of the collection canister marked in yellow
1-2. Connect the other end, with the antibac terial lter mark ed “OUT ” side, to the “ AIR INLET ”
connector of the suction unit mark ed in yellow .
1-3. Connect the connecting P VC tubing (Ø7mm, 180cm) to the “P A TIENT ” inlet of the collection
canister .
1-4. Connect the power cord with AC adaptor , inser t AC adaptor into the AC adaptor jack on the
right side of the unit.
Note: Use only the authorized Rossmax AC adaptor with this aspirator .
Note: Ensure that the FL UID SIDE or IN marker on the lter is on the side facing the collection
canister and t into the “V A CUUM” inlet. A wrong connection may cause immediate
destruction in case of contact with suck ed liquids.
2. Setup Before Use
2-1. Before each use, inspec t the unit and accessories. If damaged, expired and/or deteriorated,
replace it at once.
2-2. Place the unit on a at, horizontal surface.
2-3. Plug the AC adaptor int o the socket.
2-4. Place the switch to the “I” (ON) position.
2-5. Collapse the tubing on the antibacterial lter and check the vacuum gauge to test that the
unit makes vacuum without any leak age and this level varies when the vacuum regulator is
acted on.
Before using the device , the manufacturer advises you to clean and/or disinfect the accessories.
Switch o the device befor e any cleaning procedures and unplug the A C adaptor from the socket.
Cleaning of the device
Use only a damp cloth with antibacterial soap (non-abrasive and with dissolvents of any sort) to
clean the external sur faces of the main unit.
Caution:
• P ar ticular care should be tak en to ensure that the internal par ts of the device do not get in touch
with liquids.
• Do not submerge in water as this will result in damage to the vacuum pump .
• Do not use any cleaners or disinf ectants that contain ammonia, benzene and/or acetone to clean
the unit.
Collection canister and connecting tubing
• Detach the suc tion catheter (24), the manual regulator (23) and the connec ting PVC tubing (22)
from the collection canister .
• Disconnect the silicone tubing (20) from both the canister and the device.
• Remove the canister from its holder . Keep it upright, and empt y it (in the WC at home, in the
biological waste container in the hospital) and clean it after each use.
Disassemble it as below :
1. Open the collection canister by pressing the switch button.
2. Remove the overow valve (16) from the canister lid (15).
3. Remove the rubber valve and oat (16a) from the o ver ow valve (16).
4. Remove the silicone gasket (15a) from the canister lid (15).
Sanitization and Disinfection operations
W arning:
• T o prevent possible risk of infection from contaminated cleaning/disinfection solutions, always
prepare fr esh solution for each cleaning cycle and discard solution after each use.
• Contaminated devices must be thoroughly cleaned prior to disinf ection.
• Personal pr otective equipment must be worn when handling contaminated equipment,
particular ly tubing, lter and collection canister (protective clothing , disposable lat ex glo ves, mask,
eye protection)
• If any liquid accidentally enters in the main unit or in the pump, the unit may be damaged .
F or this reason, we r ecommend not to use the aspirator . The failure should invalidat e the guarantee
under the manufacturer ’ s responsibility .
• AC Operation: Connect the AC adaptor with the AC adaptor jack on the right side of the unit. Plug
AC adaptor into a g rounded wall-outlet power source.
• Battery Operation: The suction unit is equipped with a factory-installed and high-capacity
rechargeable lithium-ion battery and has a LED light for low battery and charge indication. The
device is supplied with the batter y partially charged. We ther efore recommend fully char ging the
battery for a minimum of 5 hours for initial use (please see battery charging).
Switch the device on by pressing the “ON/OFF” button and the g reen battery indicator comes on. If
the green light goes out during use, and the orange light comes on, ther e are about few minutes of
battery charge lef t (reserve level). Therefor e, terminate the application if possible. If the application
cannot be terminated , it can be continued until the orange light ashes, but if this occurs do not use
the appliance for more than 3 minut es to avoid damaging the battery. T o continue the application
with the battery at, connec t the unit to an external power source.
W ARNING: If you get the low battery warning symbol, immediately switch to use an AC adaptor
(external power source) to avoid an interrupted suc tion procedur e. If the unit does not
receive external power or the battery does not get recharged immediately , the low
battery indicator k eeps ashing and it will shut down rapidly .
Note:
1. When the battery power drops below a set level the aspirator shuts down to av oid damaging the
battery.
2. T o operate the unit from an internal rechar geable batter y , ensure that no external power source
(AC adaptor) is plugged into the suction unit. During charging or running of the unit, the po wer
supply may become warm to the touch. This is normal.
3. The AC adaptor can be used with the unit individually (without battery pack).
Battery char ging: This GREEN light ashes while the battery is charging. The light will
illuminate when the battery is fully charged.
Low batter y state: This ORANGE light ashes when the batter y power is about to run out
and must be charged as soon as possible.
Middle batter y state: This ORANGE light illuminates when there ar e about few minutes of
battery charge left (reser ve level).
High batter y state: This GREEN light illuminates when the battery has adequate power .
Po wer Saving state: This GREEN light illuminates when the P owering Saving operation is
activated.
• Before using the r echargeable batter y f or the rst time, charge the battery f or a minimum of 5 hours
to make sure it is fully charged.
• When charging the batter y , use an external power source (AC adaptor) and verify that the Green
charging indicator ashes when the po wer switch of the unit is in the “O” ( OFF) position.
The battery is N OT charged when the unit is in use, even the AC adapt or is plugged. Please be sure
that the device you are using has a battery installed prior to contacting your local distributor if the
battery is not charged.
• Discharging the batter y completely will shorten the life of the batter y . I f the low battery ORANGE
light ashes, do not operate the unit for more than 3 minutes. Recharge the battery as soon as
possible.
• The GREEN charging indicator will keep ashing while the battery is charging.
• As the battery nears a full charge, the high battery state GREEN light will illuminate, not ash.
Note:
1. Recharging the batter y to full capacity ma y take up to 5 hours depending on the degree of
discharge. The batt er y should be recharged every month if the unit is not in use for extended
periods. The unit can be left charged when it is not in use to ensure that the batt er y is always
charged to the optimal level . A fully- charged battery will provide approx. 45 minut es under normal
operation and approx. 60 minutes under po wer saving operation/ economical mode. Operation
time will decrease with higher vacuum levels.
2. Unit run time will decrease as the battery ages.
W arning:
• If the uid in the battery gets into your eye, wash the eye with sucient water without rubbing the
eye, then immediately consult the doctor f or treatment. There is danger in losing your eyesight.
• Do not use the exclusive battery pack other than those provided with the unit, or it will void the
warranty.
• Do not thr ow the batter y pack into re, or heat, or disassemble it. It may cause heat, ig nition, shor t-
circuit, or rupture .
Caution:
• Do not shor t-circuit the connector of the battery pack with a metal objec t such as wire.
• If the uid in the batter y is stained on your sk in or clothes, immediately wash o the uid with
water . Y ou may suer injur y or the battery may leak , heat, ignite r e, or explode.
1. Remove the screw on the battery cover located on the back side of the unit.
2. Disconnect the battery pack from the port and replace with a new one. Put the connector of
battery pack into the por t of batter y bay .
3. Install the batt er y cover and fasten it with screw . At this time, be careful not to pinch the lead wire .
4. Connect the unit with the AC adaptor , and then charge the battery pack.
The batter y pack is par tially charged. Before using the batter y for the rst time, charge the batter y
for a minimum of 5 hours to ensur e it is fully charged.
Note:
1. Battery replacement must be per formed following the above procedures. If there are any
problems, please contact your local distributor or authorized Rossmax service center for further
help.
2. It is recommended to replace the batter y e very 2 years, but the physical ser vice life depends on
the number of uses. I f the unit does not operate for more than 10 minutes after fully charging ,
substitute the battery with a new one.
3. Batteries or damage from old batteries are not cov ered by warranty.
4. Batteries are hazardous waste . Do not dispose them together with the household garbage.
Po wer saving operation can extend the operating time of rechargeable battery up to 60 minutes
during ser vice interruption and can also be used when low noise is needed.
1. Switch on the unit (ON/OFF switch).
2. Pr ess the “Pow er Saving” key, and the indicator of Gr een light illuminates during use.
3. T o deactivate the pow er saving operation and return to normal operation, press the “P ower
Saving” key again, and the green light will go out.
13. Repairs must be done only by your local distributor or authorized Rossmax ser vice center .
Unauthorized repairs void the warranty and may be hazardous f or the user .
Attention: Do not modify this device without authorization from Rossmax.
14. The lter used by the same patient is recommended to be r eplaced after ever y application.
Attention: The antibacterial lter must be r eplaced for each new patient.
15. The suction catheter and the manual regulator are sterile, disposable pr oducts for single use and
must be replaced after every application.
Check the expir y date on the original packaging of the suc tion catheter and check the integrity of
the sterile packaging. If expired and/or deteriorated , replace it at once.
Attention: The suction catheter and manual regulator ar e not supplied by Rossmax.
Rossmax declines any responsibility for harm to the patient c orrelated to the deterior ation
of the aforementioned st erile packaging due to THIRD P ARTY handling during the original
packaging of the entire device
16. Do not use sterile accessories when the sterile packaging is damaged.
17. Do not connect this de vice to a passive drainage tube .
18. Do not operate the device on an obstructed, unstable sur face to avoid incidents, which ma y cause
it to accidentally fall and lead to a malfunction and/or break age. Should there be signs of damage
to the plastic parts, which may expose inner par ts of the device, do not connect the plug to the
electrical socket. Do not attempt to make the device work befor e it has been thoroughly checked
by qualied personnel and/or authorized Rossmax ser vice center
19. Never obstruct the air inlet positioned on the device.
20. Use of the device in ambient conditions other than those specied in the manual may seriously
impair its safety and technical characteristics.
21. Before cleaning the device, pull the plug out of the x ed mains socket.
22. The connecting tubing supplied with the canister must never come into direct contact with the
suction area.
23. Never use while drowsy or asleep.
24. Always unplug the product immediately after use.
25. Use the device only in dust-free conditions, otherwise treatment could be compromised.
Caution:
1. Use only for the purpose intended . Do not use for anything other than the use dened by
the manufacturer . The manufacturer will not be responsible f or damage due to improper use or
connection to an electrical system not complying with current regulations.
2. Do not tip the canist er o ver while the device is work ing as the liquid may be aspirated into the device
causing pump damage. Should this occur, immediately switch o the suction machine, then empt y
and clean the canister . Immediately bring the device to your local distributor or authorized Rossmax
ser vice center .
3. Ensure that the connecting tubing and the canister lid have been carefully sealed in order to a void
leakage of suction.
4. When the overow valve inter venes, suction is halted. Switch o the de vice, empty the canister and
carr y out the cleaning procedures .
5. I n the event of aspiration without the canister and/or antibac terial lter , or if it is suspected that
substances have enter ed the aspiration circuit, contact your local distributor or authorized Rossmax
ser vice center at once.
6. Portable and mobile RF communications equipment can aect medical devices.
7. The AC adaptor and rechargeable battery provided have been specically desig ned for use with
Rossmax series aspirators. Never use the AC adapter and r echargeable battery with other devices or
for uses other than those specied in this manual, and nev er use Rossmax series aspirators with other
power supply units.
8. Before connecting the device always check that the electric data indicated on the data label and the
type of plug used.
9. The device casing is not waterproof. Do not wash the device under running water or by immersion
and keep it saf e from being sprayed by water or other liquid .
10. Keep the AC/DC switching adaptor away fr om animals (for example, rodents) which could damage
the insulation.
11. K eep the device and AC/DC switching adaptor a way from sources of heat, direct sunlight or extreme
hot locations.
12. When the liquid level r eaches 50% of the total volume of the collection canister , it is recommended
to empty or change it before the over ow valve acts, in this way the risk of the entrance of humidity
in the antibacterial lter is minimized.
13. The Rechargeable Lithium-ion battery integrated in the device is not to be considered as an ordinary
domestic waste. Such a component must be disposed of in a specic collection center in order t o
be recycled.
2-6. Obstruct the connec ting tubing and adjust the level of vacuum prescribed by the doctor in the
vacuum gauge turning the vacuum ow adjustment knob/ vacuum regulator .
Note: The vacuum regulator can be used to set the level of vacuum required (mmHg/kP a). Turn
the regulator clockwise, in the “+” direction, to obtain a higher vacuum; or anticlockwise for
a lower vacuum; these values can be read on the vacuum gauge .
Impor tant: The vacuum values on the c ontrol decal are purely f or guidance; alway s refer
to the reading shown on the v acuum gauge.
Note: Gauge is for ref erence only. I f the unit sustains a severe drop, accuracy of the gauge must
be checked.
2-7. Place the switch to the “O” (OFF) position.
Note: 1. The device is intended to be used on a at, horizontal sur face in order for the over ow
valve to function correctly and prevent liquids from entering the suction pump. The
device must be kept away from walls to allow f or adequate engine cooling.
2. In case unit is dropped, always transpor t unit with vacuum regulat or rotated fully clock wise.
3. Starting the Suc tion
3-1. Connect the suction catheter to the connecting PV C tubing (Ø7mm, 180cm).
Note: suction c atheter and manual r egulator are not supplied by Rossmax.
3-2. Switch on the unit (ON/OFF switch).
3-3. Place your nger on the manual regulator to activate the suction, begin suction on the patient
using the suction catheter . The unit is ready to put the suction catheter to the patient.
3-4. After application, switch o the device and remove the AC adaptor from the mains socket.
Perform the cleaning operations as described in the “"cleaning, sanitization, disinfection " .
paragraph.
Note: A 30-minute interval is recommended after each use. Do not operate the device continuously
for more than 30 minut es f or a single use without turning it o and follo wing with a cooling
period for at least 30 minutes.
3. Unit run time will also be reduced by letting the battery sit at a discharged state for extended
periods.
Storage Not e: Batter y should be charged f or a minimum of 5 hours prior to storage, and at least
once every month.