Rossmax Aspirator V3 Instruction Manual

Introduction

Thank you for purchasing the Rossmax Aspirator V3. It is crucial for healthcare workers and patients to read and understand this information for proper use and maintenance.

Intended Use

The Suction unit (Aspirator) V3 is designed to remove unwanted fluids or infectious materials from the airway or respiratory support system in healthcare settings, including hospitals and home care. It generates suction (aspiration) to extract fluids through connecting tubing into a collection canister. Use of this device must be prescribed by a doctor. Follow all recommended operations and procedures in this guide for optimal function and device longevity.

Preliminary Remarks

This Suction unit (Aspirator) V3 complies with European regulations and bears the CE mark "CE 1639". Its quality has been verified against the EC council directive 93/42/EEC amended by 2007/47/EC (Medical Device Directive), Annex I essential requirements, and applied harmonized standards, including EN ISO 10079-1: 2015 for Medical suction equipment.

Device Overview

The Rossmax Aspirator V3 features a main unit with a collection canister attached. Key components visible include a vacuum gauge to monitor suction levels, a vacuum flow adjustment knob/regulator to control suction strength, an ON/OFF switch, and an AC adaptor port. The model name "V3" is prominently displayed on the unit.

Warnings and Safety Instructions

DANGER: Urgent safety information for hazards that will cause serious injury or death.

• The device is intended exclusively for the collection of NON-flammable or NON-corrosive fluid materials in medical applications. It should not be used with flammable anaesthetic mixtures or in the presence of oxygen or nitrous oxide.
• Do not use outdoors or where aerosol products are used, or where oxygen is administered in a closed environment.
• Do not handle the AC/DC switching adaptor plug with wet hands or use the unit while bathing or showering. Never submerge the device in liquids.
• If the unit, plug, or AC adaptor is worn, wet, or if the device falls into water, disconnect the mains switch, pull the plug, and contact a Rossmax service center immediately. Do not attempt to operate before it is checked by qualified personnel.
• Do not place or store the device where it can fall into a tub or sink.

WARNING: Important safety information for hazards that draws attention to a potential danger.

• The medical device must NOT be used in the operating theater, for drainage, thoracic drainage, or nasogastric suction.
• Never operate if the cord or plug is damaged, if it is not working properly, if it has been dropped or damaged, or if it has been dropped into water. Return to a Rossmax service center for examination and repair.
• For use only by medically trained persons adequately trained in suction procedures.
• Incorrect use can cause pain and injury to the patient.
• Do not start the machine if you suspect explosive/inflammable liquids/gases, water inside, or if environmental conditions are outside specified limits.
• Do not perform maintenance while the device is in use on a patient.
• A replacement device must always be available if a breakdown could lead to a critical situation for patients (e.g., acute dyspnoea).
• Patients should be monitored regularly. Report any signs of infection or complication immediately.
• Consult indications for use and risk factors before using. Failure to follow instructions may result in serious or fatal injury.
• For children and non-self-sufficient individuals, use under close adult supervision by trained personnel.
• Keep small parts out of reach of children.
• Do not use provided tubing and AC adaptor for other purposes; they can cause risk of strangulation. Be attentive with children and individuals with disabilities.
• Repairs must be done only by authorized Rossmax service centers. Unauthorized repairs void the warranty and may be hazardous.
• Do not modify this device without Rossmax authorization.
• The filter used by the same patient is recommended to be replaced after every application.
• The antibacterial filter must be replaced for each new patient.
• Suction catheters and manual regulators are sterile, disposable products for single use and must be replaced after each application. Check expiry dates and packaging integrity.
• Rossmax declines responsibility for harm related to deterioration of sterile packaging due to third-party handling.
• Do not use sterile accessories if the sterile packaging is damaged.
• Do not connect this device to a passive drainage tube.
• Do not operate on an obstructed or unstable surface. If plastic parts show damage exposing inner parts, do not connect to power and have it checked.
• Never obstruct the air inlet.
• Using the device in conditions other than specified may impair safety and technical characteristics.
• Before cleaning, unplug the device.
• Connecting tubing must never come into direct contact with the suction area.
• Never use while drowsy or asleep.
• Always unplug the product immediately after use.
• Use the device only in dust-free conditions.

CAUTION: Indicates correct operating or maintenance procedures to prevent damage to the product or other property.

• Use only for the intended purpose. Manufacturer is not responsible for damage due to improper use or non-compliant electrical systems.
• Do not tip the canister over while working; liquid aspiration can damage the pump. If this occurs, switch off, empty/clean the canister, and contact a Rossmax service center.
• Ensure connecting tubing and canister lid are carefully sealed to avoid suction leakage.
• When the overflow valve intervenes, suction halts. Switch off, empty the canister, and carry out cleaning procedures.
• If aspiration occurs without the canister/filter, or if substances enter the aspiration circuit, contact a Rossmax service center immediately.
• Portable and mobile RF communications equipment can affect medical devices.
• Use only the authorized Rossmax AC adaptor. Never use it with other devices or for other uses. Never use Rossmax aspirators with other AC adaptors.
• Before connecting, check the electric data on the label and the plug type.
• The device casing is not waterproof. Do not wash under running water or submerge. Keep away from sprayed liquids.
• Keep the AC/DC switching adaptor away from animals that could damage insulation.
• Keep the device and adaptor away from heat sources, direct sunlight, or extreme hot locations.
• When the liquid level reaches 50% of the collection canister volume, empty or change it to minimize humidity entering the antibacterial filter.

Note/Attention: Indicates information to which users should pay special attention.

• The collection canister and tubing after disinfecting should be dated and stored in clean, dry areas to avoid recontamination.
• Do not use cleaners or disinfectants containing ammonia, benzene, or acetone.
• Dispose of solutions according to the disinfectant manufacturer's instructions.
• Dispose of the suction catheter according to local laws and regulations.

Microbial Contamination

For pathologies with a risk of infection and microbial contamination, personal use of accessories, the collection canister, connecting tubing, and antibacterial filter is recommended. All accessories should be thoroughly cleaned and disinfected after each use. Use only original Rossmax accessories.

Accessories (Optional)

Collection Canister - 1400 ML

The collection canister is made of PC (polycarbonate) material and includes an overflow valve. It must be replaced if there are visible signs of damage.

Note:

• Keep the device vertical for the overflow valve to function correctly.
• Do not overturn the collection canister during use to prevent overflow valve intervention. If it occurs, switch off the aspirator and detach the tubing connected to the antibacterial filter.
• To accelerate aspiration and simplify cleaning, it is recommended to add water to the collection canister before use.
• Suction is automatically obstructed when liquid reaches the overflow valve on the underside of the canister lid.
• Empty the container when the automatic overflow valve is activated. Further suctioning can damage the vacuum pump.

Filter

The antibacterial filter supplied with Rossmax aspirators must be strictly replaced for each new patient, or if overflow occurs or the filter becomes saturated. For single-patient use, replacement after every application is recommended. It should also be replaced if the unit is used with a patient whose contamination risk is unknown. The filter cannot be sanitized, disinfected, or sterilized.

Note:

• Do not use the aspirator without the antibacterial filter, as it can damage the unit and become dangerous for the patient from a bacteriological standpoint.
• Do not substitute any other material for this antibacterial filter, as it may lead to contamination or poor performance. Use only Rossmax filters.

Silicone and PVC Tubing

The tubing is recommended for single use. However, the number of disinfection and cleaning cycles is linked to its employment. After each cleaning cycle, the user must verify if the tubing is suitable for reuse. Replace the component if there are visible signs of decay.

Maintenance

The suction equipment requires no maintenance or lubrication. However, inspect the unit and accessories before each use.

DANGER: Electric shock hazard. Do not attempt to open or remove the cabinet; there are no user-serviceable internal components. If service is required, return the device to your local distributor or authorized Rossmax service center. Opening or tampering with the unit will void the warranty.

Rules for Returning and Repairing

Rossmax requires specific procedures to protect the instrument and user safety:

• Before returning for repair, disinfect external surfaces and all accessories with a cloth soaked in methylated spirits or a hypochlorite-based solution.
• Place the instrument and accessories in a bag with a note detailing the disinfection undertaken. Failure to do so will result in the instrument being returned unrepaired.
• Instruments returned for repair MUST be accompanied by a description of the problem.
• Rossmax is not responsible for damage caused by improper use. Read instructions carefully to avoid such damage.
• Rossmax is not responsible for damage to accessories; they will be replaced at the customer's expense.

Technical Specifications

Symbols

Troubleshooting

If the device is still not working properly after checking the conditions below, consult your local distributor or authorized Rossmax service center.

Electromagnetic Compatibility Information

1. This device needs to be installed and put into service in accordance with the information provided in the user manual.

2. WARNING: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the V3, including cables specified by the manufacturer. Otherwise, degradation of the performance of this device could result.

If higher IMMUNITY TEST LEVELS than those specified in Table 9 are used, the minimum separation distance may be lowered. Lower minimum separation distances shall be calculated using the equation specified in 8.10.

Manufacturer's declaration-electromagnetic immunity

The V3 is intended for use in the electromagnetic environment specified below. The customer or the user of the V3 should assure that it is used in such an environment.

NOTE1: At 80 MHz and 800 MHz, the higher frequency range applies.

NOTE2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

More information on EMC compliance of the device can be obtained from Rossmax website: www.rossmax.com.

Warranty Card

This instrument is covered by a 2-year guarantee from the purchase date. The guarantee is valid only on presentation of the guarantee card completed by the dealer confirming the purchase date or the receipt. Suction unit accessories are not included. Opening or altering the instrument invalidates the guarantee. The guarantee does not cover damage, accidents, or non-compliance with the instruction manual. Please contact your local seller/dealer or www.rossmax.com.

Customer Name: ____________________________________________________

Address: ___________________________________________________________

Telephone: _________________________________________________________

E-mail address: ______________________________________________________

Product Information

Date of purchase: ___________________________________________________

Store where purchased: ____________________________________________________________________

Instructions for Use

Before each use, inspect the unit and accessories for malfunctions or damage. Ensure accessories are clean and free of debris. Personal use of accessories is recommended to prevent infection.

1. Assembling Procedures

1. Connect one end of the connecting silicone tubing (Ø8mm, 14cm) with the antibacterial filter marked "IN" side to the VACUUM inlet of the collection canister (marked in yellow).
2. Connect the other end, with the antibacterial filter marked "OUT" side, to the "AIR INLET" connector of the suction unit (marked in yellow).
3. Connect the connecting PVC tubing (Ø1/4", 180 cm) to the "PATIENT" inlet of the collection canister.
4. Connect the AC adaptor to the AC adaptor jack on the right side of the unit.

Note: Use only the authorized Rossmax AC adaptor. Ensure the filter's "FLUID SIDE" or "IN" marker faces the collection canister and connects to the "VACUUM" inlet. Incorrect connection may cause immediate destruction if liquids are sucked.

2. Setup Before Use

1. Before each use, inspect the unit and accessories. Replace if damaged, expired, or deteriorated.
2. Place the unit on a flat, horizontal surface.
3. Plug the AC adaptor into the socket.
4. Set the switch to the "I" (ON) position.
5. Check the vacuum gauge to ensure the unit makes vacuum without leakage and that the level varies when the vacuum regulator is adjusted.
6. Obstruct the connecting tubing and adjust the vacuum level prescribed by the doctor using the vacuum flow adjustment knob/vacuum regulator. Turn clockwise (+) for higher vacuum, anticlockwise for lower vacuum. Read values on the vacuum gauge.

Important: Vacuum values on the control decal are for guidance only; always refer to the vacuum gauge reading.

Note: Gauge is for reference only. Accuracy must be checked if the unit sustains a severe drop.

7. Set the switch to the "O" (OFF) position.

Note:

• The device must be used on a flat, horizontal surface for correct overflow valve function and to prevent liquids entering the pump. Keep the device away from walls for adequate cooling.
• If the unit is dropped, always transport it with the vacuum regulator rotated fully clockwise.

3. Starting the Suction

1. Connect the suction catheter to the connecting PVC tubing (Ø1/4", 180 cm).
2. Switch on the unit (ON/OFF switch).
3. Place your finger on the manual regulator to activate suction, then begin suction on the patient using the suction catheter.
4. After application, switch off the device and remove the AC adaptor. Perform cleaning operations as described in the "Cleaning, Sanitization, Disinfection" paragraph.

Note: A 30-minute interval is recommended after each use. Do not operate continuously for more than 30 minutes without a cooling period of at least 30 minutes.

Cleaning, Sanitization, Disinfection Operations

Before using the device, clean and/or disinfect the accessories. Switch off the device and unplug the AC adaptor before any cleaning procedures.

Cleaning of the device

Use only a damp cloth with antibacterial soap (non-abrasive, without dissolvents) to clean the external surfaces of the main unit.

Caution:

• Ensure internal parts do not contact liquids.
• Do not submerge in water, as this will damage the vacuum pump.
• Do not use cleaners or disinfectants containing ammonia, benzene, or acetone.

Collection canister and connecting tubing

• Detach the suction catheter, manual regulator, and connecting PVC tubing from the collection canister.
• Disconnect the silicone tubing from both the canister and the unit.
• Remove the canister from its holder, keep it upright, empty it, and clean it after each use.
• Disassemble the canister: Open it, remove the overflow valve from the lid, and remove the rubber valve and float from the overflow valve.

Sanitization, Disinfection operations

Warning:

• Prepare fresh cleaning/disinfection solutions for each cycle and discard after use to prevent infection risk.
• Contaminated devices must be thoroughly cleaned prior to disinfection.
• Wear personal protective equipment (gloves, mask, eye protection) when handling contaminated equipment.
• If liquid enters the main unit or pump, the unit may be damaged and the guarantee invalidated.
• If contaminated fluids have moved past the internal unit, remove tubing and filter, clean the casing, decontaminate the collection canister, and return the device to a Rossmax service center.

1. Sanitization

Before and after each use, sanitize the collection canister and connecting tubing. Rinse each part with clean, hot running water (<50°C) with gentle dishwashing liquid. Leave parts to dry in an open, clean environment.

2. Disinfection

The accessories that can be disinfected are the canister, lid, overflow valve, and rubber valve. Choose one of the methods below:

• Method A: Use a commercial disinfectant (electrolytic chloroxidizer, e.g., sodium hypochlorite) following the manufacturer's instructions and dilution rates.
• Method B: Boil each part in water for 15-20 minutes, preferably using de-mineralized or distilled water.

Disinfection is effective only if parts have been previously sanitized. After cleaning, leave parts to dry in an open, clean environment.