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Rossmax V5 Handleiding

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Introduction
Intended Use
Warnings and Safety Instructions
DANGER, WARNING, CAUTION, NOTE/ATTENTION STATEMENT
Instructions for Use
Cleaning, Sanitization, Disinfection operations
We thank you for purchasing our Aspirator V5 which is adaptable to your needs. It is
very important that the health care worker and/or the patient read and understand
the information for use and maintenance.
Suction unit (Aspirator) V5 can be used to remove unwanted uids or infectious
materials from the airway or respiratory support system in health care structures like
hospitals and home care. The device generates suction (aspiration) which allows
uids to be extracted through connecting PVC tubing connected 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 follow the recommended
operations and procedures outlined in this instruction guide to ensure proper
functioning and maximize the life of the device.
Suction unit (Aspirator) V5 is EMC-tested in conformity with the requirements of IEC
60601-1-2 and can be used in the vicinity of other EMC-tested devices that fulll
the requirements as outlined in the IEC 60601-1-2 standard. Untested HF sources,
radio networks or the like can impair the function of the device and should not
be operated in combination with the Aspirator V5. The suction equipment is not
suitable for use in an MRI environment. Please read and observe these warning
and safety instructions before operation. These instructions for use must be kept
with the device for later reference. Please note that these instructions for use are
a general guide for the use of the product. Medical matters must be addressed
by a physician. Rossmax considers himself only responsible for the eect on BASIC
SAFETY, reliability and performance of the Aspirator V5 if it is used in accordance
with the instructions for use.
Important Safeguards
This is a medical device and must be used by qualied users. It must be
operated as indicated in this user instruction manual.
Read All Instructions Before Using This Device.
Save These Instructions.
The manufacturer makes every eort to ensure that every product is of the highest
quality and safety; however, as for any electrical appliances, basic safety regulations
must always be observed in order to avoid harming persons and things.
DANGER: Urgent safety information for hazards that will cause serious injury
or death.
WARNING: Important safety information for hazards that draws attention to a
potential danger.
CAUTION: Indicates correct operating or maintenance procedures to prevent
damage to the product or other property.
Note/Attention: Indicates information to which users should pay special
attention.
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 a 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
where oxygen is being administered in a closed environment such as an oxygen
reservoir.
3. Do not handle the plug with wet hands or use the unit when taking a bath
or shower. Never submerge the device in any liquids.
4. Do not use the unit if the plug are worn or wet and remove or touch the immersed
device.
If by chance it falls into water, do not attempt to remove the device from the
water while the plug is still connected; disconnect the mains switch, pull the
plug out of the socket. Bring the device to your local distributor or authorized
Rossmax service center immediately. Do not attempt to make the device work
before it has been thoroughly checked by qualied personnel and/or authorized
Rossmax service center.
5. Do not place or store the device where it can fall or be pulled into a tub or sink.
The device must be checked 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. Furthermore, they
must be cleaned following the instructions rigorously as stated in the "Cleaning,
Sanitization, Disinfection". We recommend personal use of the accessories, the
collection canister, the connecting tubing and antibacterial lter to prevent risk of
contagious infection.
1. Assembling procedures
1-1. Connect one end of silicone connecting tubing (Ø8mm,14cm), with the
antibacterial lter marked “IN” side, to the VACUUM inlet of the collection
canister marked in yellow.
1-2. Connect the other end, with the antibacterial lter marked “OUT” side, to the
“AIR INLET” connector of the suction unit marked in yellow.
1-3. Connect the connecting PVC tubing (Ø7mm,180cm) to the “PATIENT” inlet of
the collection canister.
1-4. Connect the electric power cord as required.
Note: Ensure that the FLUID SIDE or IN marker on the lter is on the side facing the
collection canister and t into the “VACUUM” inlet. A wrong connection
may cause immediate destruction in case of contact with sucked liquids.
2. Setup Before Use
2-1. Before each use, inspect 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. Check the voltage of the environment before using the device.
2-4. Plug the power cord into the socket.
2-5. Place the switch to the “I” (ON) position.
2-6. Collapse the tubing on the antibacterial lter and check the vacuum gauge
to test that the unit makes vacuum without any leakage and this level varies
when the vacuum regulator is acted on.
2-7. Obstruct the connecting 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/kPa). 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.
Important: The vacuum values on the control decal are purely for
guidance; always refer to the reading shown on the vacuum
gauge.
Note: Gauge is for reference only. If the unit sustains a severe drop, accuracy of
the gauge must be checked.
2-8. Place the switch to the “O” (OFF) position.
Note:
1. The device is intended to be used on a at, horizontal surface 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 for adequate
engine cooling.
2. In case unit is dropped, always transport unit with vacuum regulator rotated
fully clockwise.
Before using the device, the manufacturer advises you to clean and/or disinfect the
accessories. Switch o the device before any cleaning procedures and unplug the
power cord 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 surfaces of the main unit.
Caution:
• Particular care should be taken to ensure that the internal parts 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 disinfectants that contain ammonia, benzene and/or
acetone to clean the unit.
Collection canister and connecting tubing
• Detach the suction catheter (21), the manual regulator (20) and the connecting
PVC tubing (19) from the collection canister.
• Disconnect the silicone tubing (17) from both the canister and the device.
• Remove the canister from its holder. keep it upright, and empty 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 overow valve(13) from the canister lid (12)
3.Remove the rubber valve and oat (13a) from the overow valve (13)
4. Remove the silicone gasket (12a) from the canister lid (12)
Sanitization, Disinfection operations
Warning:
• To prevent possible risk of infection from contaminated cleaning/disinfection
solutions, always prepare fresh solution for each cleaning cycle and discard
solution after each use.
• Contaminated devices must be thoroughly cleaned prior to disinfection.
• Personal protective equipment must be worn when handling contaminated
equipment, particularly tubing, lter and collection canister (protective clothing,
disposable latex gloves, mask, eye protection)
• If any liquid accidentally enters in the main unit or in the pump, the unit may
be damaged. For this reason, we recommend not to use the aspirator. The failure
should invalidate the guarantee and the technical specications under the
manufacturer’s responsibility.
• In the event that contaminated uids have moved past the internal unit, remove
the tubing and the lter, clean the casing, and decontaminate the collection
canister. Return the device to your local distributor or authorized Rossmax service
center following “Rules for returning and repairing” paragraph.
1. Sanitization
Before and after each use, sanitize the collection canister and the connecting
tubing. Rinse each part (7, 9, 12, 12a,13, 13a, 14, 17, 19) with clean, hot running
water (<50°C) with gentle dishwashing liquid (non-abrasive). After cleaning, leave
the parts to dry in an open, clean environment.
2. Disinfection
The accessories which can be disinfected are (7, 9, 12, 12a, 13, 13a, 14, 17). Wash
with a commercial disinfectant that must be an electrolytic chloroxidizer (active
principle: sodium hypochlorite) specic and follow the instructions and dilution
rates supplied by the disinfectant manufacturer carefully. It is eective on the parts
that undergo this treatment only if the parts to be treated have previously been
sanitized. After cleaning, leave the parts to dry in an open, clean environment.
Parts Material Sanitization Disinfection
Steam
Sterilization
(Gravity
autoclave)
Collection Canister
(7)
PC
(Polycarbonate) O O X
Canister supporting
handle (14) ABS/ PC O O X
Canister Lid (12) ABS/ PC O O X
WARNING:
1. The medical device must NOT be used in the operating theater, for
drainage or thoracic drainage and nasogastric suction.
2. Never operate this product if a) it has a damaged cord or plug, b) it is not working
properly, c) it has been dropped or damaged, d) it has been dropped into water.
Immediately Return the product to your local distributor or authorized Rossmax
service center for examination and repair.
3. For use only by medically trained persons who have been adequately trained in
suction procedures and in the use of aspirators.
4. Incorrect use can cause pain and injury to the patient.
5. Do not start the machine if you suspect the presence of explosive or inammable
liquids or gases, water inside the machine or environmental conditions that are
not within the specied limits.
6. Do not perform 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 for
patients can lead to a critical situation (e.g. patients with acute dyspnoea or severe
catarrhal congestion),
8. The patient should be monitored regularly according to the physicians instructions
and facility guidelines. Objective indications or signs of a possible infection or
complication must be met immediately (e.g. fever, pain, redness, increased warmth,
swelling or purulent discharge). Non-observance can lead to considerable danger
for the patient. Monitoring the Aspirator V5 for operating status is a must.
9. Consult the indications for use and consider risk factors and contraindications
before using the Aspirator V5. Failure to read and follow all instructions in this
manual prior to use may result in serious or fatal injury of the patient.
10. In the presence of children and non self-sucient individuals, the device must be
used under the close supervision of an adult who has been adequately trained in
suction procedures and in the use of aspirators.
11. Some parts of the device are small enough to be swallowed by children; keep the
device out of the reach of children.
12. Do not use the provided tubing and power cord for any other purpose than
those specied, as they can cause risk of strangulation. Be particularly attentive
with children and individuals with disabilities because they are often unable to
correctly assess risk.
13. Repairs must be done only by your local distributor or authorized Rossmax
service center. Unauthorized repairs void the warranty and may be hazardous for
the user.
Attention: Do not modify this device without authorization from Rossmax.
14. The lter used by the same patient is recommended to be replaced after every
application.
Attention: The antibacterial lter must be replaced for each new patient.
15. The suction catheter and the manual regulator are sterile, disposable products for
single use and must be replaced after every application.
Check the expiry date on the original packaging of the suction 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 are not supplied
by Rossmax.
Rossmax declines any responsibility for harm to the patient correlated to
the deterioration of the aforementioned sterile packaging due to THIRD
PARTY 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 device to a passive drainage tube.
18. Do not operate the device on an obstructed, unstable surface to avoid incidents,
which may cause it to accidentally fall and lead to a malfunction and/or breakage.
Should there be signs of damage to the plastic parts, which may expose inner
parts of the device, do not connect the plug to the electrical socket. Do not
attempt to make the device work before it has been thoroughly checked by
qualied personnel and/or authorized Rossmax service center.
19. Never obstruct the air inlet positioned on the device.
20. Use of the device in ambient conditions other than those specied in the manual
may seriously impair its safety and technical characteristics.
21. Before cleaning the device, pull the plug out of the xed 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. Don’t use for anything other than the
use dened by the manufacturer. The manufacturer will not be responsible for
damage due to improper use or connection to an electrical system not complying
with current regulations.
2. Do not tip the canister over while the device is working as the liquid may be
aspirated into the device causing pump damage. Should this occur, immediately
switch o the suction machine, then empty and clean the canister. Immediately
bring the device to your local distributor or authorized Rossmax service center.
3. Ensure that the connecting tubing and the canister lid have been carefully sealed
in order to avoid leakage of suction.
4. When the overow valve intervenes, suction is halted. Switch o the device, empty
the canister and carry out the cleaning procedures.
5. In the event of aspiration without the canister and/or antibacterial lter, or if it is
suspected that substances have entered the aspiration circuit, contact your local
distributor or authorized Rossmax service center at once.
6. Portable and mobile RF communications equipment can aect medical devices.
7. Before connecting the device always check that the electric data indicated on the
data label and the type of plug used.
8. The device casing is not waterproof. Do not wash the device under running water
or by immersion and keep it safe from being sprayed by water or other liquid.
9. Keep the power cord away from animals (for example, rodents) which could
damage the insulation.
10. Keep the device and power cord away from sources of heat, direct sunlight or
extreme hot locations.
11. When the liquid level reaches 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.
Preliminary Remarks
This Suction unit (Aspirator) complies with the European regulations and bears
the CE mark “CE 1639”. The quality of the device has been veried 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
standards.
EN ISO 10079-1:2015 Medical suction equipment - Part 1: Electrically powered
suction equipment.
3. Starting the Suction
3-1. Connect the suction catheter to the connecting PVC tubing (Ø7mm,180cm)
Note: suction catheter and manual regulator 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 Power cord 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 minutes for a single use without
turning it o and following with a cooling period for at least 30 minutes
2

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