The SAM 12, SAM 14, SAM 15, and SAM 16 are medical suction units designed for various medical procedures requiring adjustable high vacuum. These units are manufactured by M.G. Electric (Colchester) Ltd, adhering to BS EN ISO 9001 and BS EN ISO 13485 standards.
Function Description
The SAM units are general-purpose high vacuum medical suction devices. Their primary function is to create and maintain a controlled vacuum for aspirating fluids during medical procedures. The SAM 12 and SAM 14 models are designed for general-purpose high vacuum applications, suitable for domiciliary use or within healthcare facilities. The SAM 15 and SAM 16 models are high vacuum surgical suction units specifically designed for intra-uterine procedures, featuring wide-bore top collection containers with specimen filters, making them suitable for theatre or ward use.
A key safety feature across all models is the requirement for an MGE filter capsule during operation. These filter capsules are sealed, disposable, bacterial, and hydrophobic, ensuring 99.9999% bacterial retention and 99.985% Dispersed Oil Particulate (D.O.P.) retention. This provides an effective barrier against aerosol contamination, protecting both the patient and the operator. An internal hydrophobic filter is also fitted to prevent liquid from reaching the pump, which would otherwise cause damage and invalidate the warranty. This internal filter works once and must be replaced immediately if it becomes wet.
The SAM 14 and SAM 16 models are equipped with two collection containers and a changeover valve. This allows one container to be emptied and replaced while the other remains in use, ensuring continuous operation.
Usage Features
Before operating any SAM unit, users must thoroughly read the operating instructions and precautions. Only trained personnel should operate the unit. It is crucial to check that the voltage supply matches the rating plate on the back of the unit.
Unit Set-Up:
- Securely connect the desired collection system to the bracket(s) on the side of the unit.
- Connect the patient inlet tube on the collection container top to the desired equipment.
- Connect the unit to the power supply, ensuring the power cable does not create a trip hazard and the exhaust outlet is clear of obstructions.
- Switch on the unit by pressing the green rocker switch, which illuminates to indicate operation.
Vacuum Control:
The unit features a gauge (manometer) to set and monitor the vacuum level. To achieve the desired vacuum, occlude the tubing fitted to the patient inlet on the collection container top and adjust the vacuum control knob clockwise to increase the vacuum.
External Filter:
An external filter is mandatory for operation. These filters are single-patient use and must not be autoclaved. They should be changed after each day's use, if wetted by froth, after aspirating infective material, or before use on a new patient.
Fluid Collection Containers:
The SAM 2 collection container, fitted as standard, is fully autoclavable Polyester Carbonate (P.E.C.) with an integral handle. For IU applications, it has a wide bore. The container connects to the SAM unit via a moulded vacuum connector.
The SAM 2 collection container includes an overflow valve designed to shut off vacuum when the fluid level reaches 1750ml. For SAM 12 and SAM 15 units, the unit must be switched off and the container replaced when the valve operates. For SAM 14 and SAM 16 units, the changeover valve allows switching to the second container. An anti-foam agent can be used to reduce frothing.
Disposable Liner Systems:
The SAM range supports various disposable liner systems, including VacSax and Abbott Receptal. When using these systems, overflow protection relies entirely on correct use according to the manufacturer's instructions.
- VacSax System: Place the liner into the collection container, push the taper connector of the vacuum tubing into the vacuum port, connect the patient tubing, turn on the unit, confirm suction, disconnect the patient tube after the procedure, fit the stopper, turn off the unit, and remove the liner for disposal.
- Abbott Receptal System: Place the collection container in the bracket, extend the liner, secure it, connect the vacuum source tubing (from the filter) to the tee connection using the 'yellow to yellow' coding, connect the patient tube, turn on the unit to inflate the liner, and ensure the fluid level does not exceed the 'DO NOT FILL ABOVE THIS LINE' mark.
Serres Suction Bag System:
This system comprises a suction bag, collection container, and angle connector. Place the container in the bracket, connect tubing from the SAM filter to the angle connector, place the bag into the container, turn on the unit, install the bag by occluding the patient connection and pressing lightly from the lid's middle, establish desired vacuum, connect the patient tube, disconnect it after the procedure, close the connection with the plug, turn off the unit, and remove the liner for disposal.
Operating Environment:
The unit must be operated within a temperature range of -5°C to +40°C and a humidity range of 30% to 80%. Operation in the presence of flammable gases is strictly prohibited due to explosion hazard.
Transport and Storage:
The unit should be transported in its original packaging within ambient conditions of -20°C to +60°C and 30% to 80% humidity. For storage, a dry, dust-free, well-ventilated environment is required, avoiding direct sun, UV exposure, or heat sources. The unit should be stored on a shelf or wooden pallet to protect against ground moisture. For long-term storage (infrequent use), the three-monthly maintenance period can be extended to twelve months, with particular attention to flexible components.
Maintenance Features
Regular maintenance is crucial for the safe and efficient operation of SAM units. All maintenance or repairs, beyond routine daily procedures, must be carried out by fully trained and qualified Electro-Biomedical engineers/technicians (EBME) or authorized MG Electric dealers. All testing should comply with ISO 10079-1.
Safety Precautions for Maintenance:
- Always electrically isolate the SAM unit from the mains power supply by removing the power cable before any cleaning, maintenance, or repairs.
- Wear appropriate protective clothing and gloves when cleaning or replacing contaminated parts.
- Disposal of contaminated parts must follow local protocols.
- No modifications to the equipment are allowed.
- Solvent-based or abrasive cleaning agents must not be used. Do not wash or submerge units in water.
- Any dismantling and re-assembly must be followed by testing according to manufacturers' recommendations for monthly maintenance.
Daily Procedures:
- Change the external filter capsule after each day's use, if wetted by froth, after aspirating infective material, or before use on a new patient.
- Examine the collection container for damage and replace if necessary.
- Examine external tubing for ageing, damage, or contamination and replace if necessary with equivalent tubing (Ø6mm I/D with 3mm minimum wall thickness).
Monthly Maintenance:
- Perform all daily maintenance procedures.
- Check the vacuum and flow at the collection container top. With an empty container and vacuum control set to maximum, switch on the unit. Occlude the suction inlet and note the time taken for the gauge to reach 450mm Hg (60 kPa) vacuum (should not exceed 10 seconds). The gauge should stabilize at a maximum vacuum of not less than 590mm Hg (78.7 kPa).
- Replace the exhaust filters in the exhaust outlet housing.
Three Monthly Maintenance:
- Perform all monthly procedures.
- Remove the back cover.
- Check internal and external tubing for ageing or wear and replace if necessary (tubing to gauge Ø5mm I/D, wall thickness min 2mm; all other tubing Ø6mm I/D, wall thickness min 3mm).
- Replace the internal hydrophobic filter, ensuring correct orientation for flow.
- Check internal wiring for ageing or wear.
- Examine the mains cable for wear or damage.
- Replace the back cover, ensuring not to overtighten fixings (recommended torque 20 cNm).
- Examine the overflow valve float mechanism (SAM 2) for free movement.
- For SAM 14 and SAM 16, check the function of the changeover valve.
- Check vacuum and flow performance at the collection container.
Pump Maintenance (If Required):
- Remove the pump from the SAM unit.
- Remove the pump head from the casing and examine the diaphragm for wear.
- Check the balance within the connecting rod for excessive movement.
- Remove pump head nozzles and transfer valves.
- Clean valve seats and check valves for wear.
- Replace worn or damaged components and re-assemble.
- Replace the pump into the SAM unit and re-connect internal tubing. Replacement kits are available for changing old LQ25 Pumps to new MQ25 Pumps.
Replacing the Main Cable:
- Isolate the unit from the mains power supply.
- Detach the back panel to access the internal terminal block.
- Disconnect brown and blue conductors and withdraw the cable.
- Fit the replacement cable, connect conductors to respective terminals (Blue to Blue, Brown to Brown), and ensure sufficient cable length between gland and terminal block.
- Fit the cable into the labyrinth, ensure all conductors are fitted as original, check circuit continuity, and replace the back panel.
Cleaning Procedure:
- Disconnect the unit from the power supply.
- Wipe the outside case with a clean damp cloth or an appropriate mild disinfectant solution, following the cleaning product manufacturer's instructions and avoiding excessive moisture.