Sam 12
Sam 12
Sam 12
SA 15 SA 16
Medical Suction Unit
Operating and Maintenance Manual
Dear Customer,
We take this opportunity to thank you for purchasing a SA Medical Suction Unit. Please read the
operating instructions and listed precautions thoroughly before attempting to operate the unit. MG
Electric manufactures its range in accordance with the requirements of BS EN ISO 9001 and BS EN
ISO 13485
INDEX
1. SAFETY INSTRUCTIONS 4
2. GENERAL DESCRIPTION 6
3. INSTRUCTIONS FOR USE 7
3.1 Before Operating Unit
3.2 Unit Set Up
3.3 Operating Environment
3.4 Gauge (Manometer) - Indicated Vacuum
3.5 External Filter
3.6 Internal Filter
3.7 Fluid Collection Containers
3.8 Disposable Liner Systems
3.9 Effect of altitude
3.10 Cleaning Procedure
3.11 Transport
3.12 Storage
3.13 Long Term Storage
3.14 Instructions by Medical Staff to Patients
3.15 Troubleshooting
4. MAINTENANCE 12
4.1 Daily Procedures
4.2 Monthly Maintenance
4.3 Three Monthly Maintenance
4.4 General Layout
4.5 Pump (If Required)
4.6 Replacing the Internal Hydrophobic Filter
4.7 Replacing the Main Cable
4.8 Flow Diagram
5. OPTIONS AND RECOMMENDED SPARES 19
5.1 Options
5.2 Recommended spares
6. TECHNICAL SPECIFICATION 21
6.1 General Dimensions
6.2 End of life
6.3 Electromagnetic Compatibility (EMC)
7. NOTES 23
8. OTHER PRODUCTS IN THE SA RANGE 24
Ingress Protection
Electricity Warning 3 - Ingress Protection against particulates
4 - Ingress Protection against water.
Safety Warning
1. SAFETY INSTRUCTIONS
The safety of the patient and suction unit operator are the first priorities. It is therefore vital that the
following precautions are strictly observed:
WARNING!!!
The filter capsules are made to withstand limited use and cannot be reused. Reuse of such devices
can be dangerous for both patient and operator.
A hydrophobic filter must be fitted internally to prevent liquid passing through to the pump.
Hydrophobic filters only work once and should be replaced immediately it becomes wetted.
Only original and approved spare parts and collection systems must be used with all SAM suction
units – failure to use original or approved spares will invalidate the warranty and may cause injury or
damage the unit.
No liability can be accepted by MG Electric for units affected by the occurrence of overflow when
Disposable Liner Systems are being used.
Other than for routine daily procedures, any maintenance or repairs to MG Electric products must be
carried out by fully trained and qualified Electro-Biomedical engineer/technician (EBME) or an
authorized MG Electric dealer. Such persons are to be familiar with the relevant standards, rules,
accident prevention regulations, and operating conditions as a resultt of their training, experience, and
instruction. They are qualified to carry out the required activities and in doing so recognize and avoid
potential hazards. All testing on SAM units should be in accordance with ISO 10079-1
Contamination may be present on any components. When cleaning or replacing any part of the SAM
unit appropriate protective clothing and gloves MUST be worn to avoid contamination. Disposal of
contaminated parts must be according to local protocols.
Store the manual in a safe place, so that it is available to the trained personnel at all times.
The overflow valve may not operate fully against frothing. To prevent frothing anti-foam agent maybe
used.
When replacing a full collection container, be aware of its weight and ensure handling the container is
comfortable to avoid the possibility of spillage.
Solvent-based cleaning agents or abrasive cleaners must not be used on any SA units. Do not wash
any SA units under running water or submerge in water.
Any dismantling and re-assembly of this equipment - for whatever purpose - must be followed by
testing in accordance with the manufacturers’ recommendations as specified for monthly
maintenance.
ELECTRICAL WARNING
Always electrically isolate the SA unit from the mains power supply before carrying out any cleaning,
maintenance or repairs. Electrical isolation of the SA unit is by removal of the mains power cable
from the mains power supply.
Never operate a SA suction unit in the presence of flammable gas such as anaesthetic agents.
This is an Explosion hazard!
Ensure the power cable does not create a trip hazard or is subject to damage.
The suction pumps may only be opened by qualified technical personnel. Electric shock hazard!
2. GENERAL DESCRIPTION
SA 12 - General-purpose high vacuum medical suction unit, incorporating one collection container
of 2L capacity. Designed for all medical procedures that require an adjustable high
vacuum. For domiciliary use or use within a healthcare facility. These units are not
intended for field and transport use.
SA 14 - General-purpose high vacuum medical suction unit, incorporating two collection containers
of 2L capacity. Designed for all medical procedures that require an adjustable high
vacuum. For domiciliary use or use within a healthcare facility. These units are not
intended for field and transport use.
SA 15 - High vacuum surgical suction unit, incorporating one Intra-Uterine (IU) collection container
of 2L capacity. Designed for use in intra-uterine procedures. Collection containers fitted
with a wide bore top complete with specimen filter. For theatre or ward use within a
healthcare facility. These units are not intended for field and transport use.
SA 16 - High vacuum surgical suction unit, incorporating two Intra-Uterine (IU) collection containers
of 2L capacity. Designed for use in intra-uterine procedures. Collection containers fitted
with a wide bore top complete with specimen filter. For theatre or ward use within a
healthcare facility. These units are not intended for field and transport use.
The SA 14 and SA 16 are fitted with two collection containers and a simple changeover valve. This
valve enables one container to be emptied and replaced while the other remains in use.
External Filter
Vacuum Gauge
Connection to
ON/OFF Switch Collection Vessel
Vacuum Control
Collection Vessel
Bracket
Become thoroughly familiar with the operation and maintenance of the unit before using and note the
information on the control panel and rear of the unit. Only persons trained in its use should operate
the unit.
Check that the voltage supply is as printed on the rating plate fitted to the back of the SA unit.
Warning! Always electrically isolate the SA unit from the mains power supply before
carrying out any cleaning, maintenance or repairs. Electrical isolation of the
SA unit is by removal of the mains power plug from the mains power supply.
Warning! Never operate a SAM suction unit in the presence of flammable gas such as
anaesthetic agents. This is an Explosion hazard!
The filter capsules are a sealed disposable bacterial or hydrophobic filter capsule. Both the bacterial
and hydrophobic filters have bacterial retention of 99.9999% ensuring safety and hygiene for patient
and operator. The 0.3 micron particle retention of the filter medium also gives not less than 99.985%
Dispersed Oil Particulate (D.O.P.) and so provides an effective barrier against possible aerosol
contamination. The hydrophobic filter also has an integrated micro porous membrane on the rear of
the filter medium which allows a clear flow of air through one way and an excellent block against any
accidental back flow the other. The external filters are fitted between the vacuum connector and the
filter capsule mount, and can be either a bacterial or hydrophobic filter. The connector, mount, and ‘O’
rings are autoclavable. However, the filter capsules are ‘Single Patient Use’ and must not be
autoclaved. The external filter must be changed with every patient and renewed in accordance with
the recommendations detailed in the ‘Daily Procedures’.
Warning! The filter capsules are made to withstand limited use and cannot be reused.
Reuse of such devices can be dangerous for both patient and operator.
Warning! A hydrophobic filter must be fitted internally to prevent liquid passing through to
the pump. Hydrophobic filters only work once and should be replaced
immediately it becomes wetted.
An anti-foam agent may be put into the fluid collection container, without disinfectant solution, before
use to reduce the possibility of frothing. It should not however, be placed into the container for
extended storage periods.
The SA 2 is fitted with an overflow valve designed to shut off the vacuum to the SA 2 collection
container when the fluid level reaches 1750ml. When the valve operates, the SA 12 and SA 15 units
must be switched off and the full container replaced by an empty one. The SA 14 and SA 16 have
two SA 2 collection containers and where appropriate the full container may be replaced by the
second container through operation of the changeover valve located on the top of the unit.
It should be noted that even after the valve has shut off, fluid might continue to be drawn into the
container to an extent dependent upon the level of vacuum in the container at the time when the valve
closes.
Warning! The overflow valve may not operate fully against frothing. To reduce frothing
anti-foam agent may be used.
Warning! When replacing a full collection container, be aware of its weight and ensure
handling the container is comfortable to avoid the possibility of spillage.
Transport of the SA unit with a full jar attached is not advised.
Warning! No liability can be accepted by MG Electric for units affected by the occurrence
of overflow when Disposable Liner Systems are being used.
The collection container may be sterilised by autoclaving at 121°C or by washing with water based
disinfectants. Before autoclaving, rinse the collection container well to remove any detergent.
• At the end of the procedure, the SA unit should remain switched on while the
patient suction tubing is removed from the patient port and discarded.
• Disconnect the liner lid tubing from the tee connection and immediately reconnect
the yellow connector to the patient port with a push and twist motion.
• Turn the vacuum off and use the thumb tab to remove the liner for disposal.
Warning! The liner lid tubing must not be used as a carry handle.
Warning! Always electrically isolate the SA unit from the mains power supply before
carrying out any cleaning, maintenance or repairs. Electrical isolation of the
SA unit is by removal of the mains power cable from the mains power supply.
Warning! Solvent-based cleaning agents or abrasive cleaners must not be used on any
SAM units. Do not wash any SAM units under running water or submerge in
water.
To clean the outside case of the SA suction unit, disconnect the unit from the power supply, wipe
over with a clean damp cloth or use an appropriate mild disinfectant solution. Following the
manufacturers’ instructions on cleaning product, and avoiding excessive moisture.
3.11 Transport
The SA unit will be adequately boxed and protected to ensure no damage occurs during normal
transportation of goods, providing the ambient conditions are within the following parameters:
Temperature max +60°C min -20°C Humidity max +80% min +30%
-20°C
Temperature max +60°C min -20°C Humidity max +80% min +30%
-20°C
If a problem cannot be solved, contact a fully trained and qualified engineer (EBME), authorized MG
Electric dealer or MG Electric (sales@mgelectric.co.uk).
4. MAINTENANCE
Warning! Other than for routine daily procedures, any maintenance or repairs to MG
Electric products must be carried out by fully trained and qualified engineers
(EBME) or an authorized MG Electric dealer. Such persons are to be familiar
with the relevant standards, rules, accident prevention regulations, and
operating conditions as a result of their training, experience, and instruction.
They are qualified to carry out the required activities and in doing so recognize
and avoid potential hazards. All testing on SA units should be in accordance
with ISO 10079-1
Warning! Any dismantling and re-assembly of this equipment - for whatever purpose -
must be followed by testing in accordance with the manufacturers’
recommendations as specified for Monthly maintenance.
Warning! Isolate the SA unit from the mains power supply before carrying out any
maintenance or repairs. Electrical isolation of the SA unit is by removal of the
mains power cable from the mains power supply.
Vacuum connector
to collection
container External tubing
External Filter
Filter Mount
Warning! Always electrically isolate the SA unit from the mains power supply before
carrying out any cleaning, maintenance or repairs. Electrical isolation of the
SA unit is by removal of the mains power cable from the mains power supply.
Pump Head
Connector Set
Seal Kit
Con-Rod
Assembly
When replacing filters, particularly the hydrophobic filter, it is important to ensure the filter is connected
correctly to suit the direction of flow. The filters will only operate efficiently in one direction. The flow
diagram indicates the correct orientation installed in the pipework.
Warning! Always electrically isolate the SA unit from the mains power supply before
carrying out any cleaning, maintenance or repairs. Electrical isolation of the
SA unit is by removal of the mains power cable from the mains power supply.
• Disconnect the brown and blue conductors of the cable from the terminal block, and
withdraw the cable.
• Fit the replacement cable through the access hole.
• Connect the conductors to their respective terminals (Blue to Blue and Brown to
Brown) in the terminal block. Provide sufficient length of cable between the gland
and terminal block.
• Fit the cable into the labyrinth.
• Ensure all conductors are fitted as the original.
• Check continuity of each circuit.
• If reconnection is correct - replace the back panel.
SA 12 and SA 15
SA 14 and SA 16
16 04 Pennine 04 Spanish
05 SA 4 (4Ltr) 05 European
SA 06 VacSax 06 Aus/NZ
07 Serres
Cardinal
08
Medline
09 Cardinal CRD
10 SA 2 Holder
11 MTP
Flowmeter
13
Flovac
Example: SA 12 / 01 01 01 01
All spares can be purchased by the user from MG Electric directly. Not all available spares are listed
below. Please contact the MG Electric sales team for a full list. (sales@mgelectric.co.uk)
It is recommended that only competent persons should undertake the replacement of spare parts.
Filter capsule mounts with ‘o’ rings and fixings – 10pk MSP1017
Handle with fixings MSP1027
2amp 20mm fuses – 10pk MSP1225
Power cable – 2M MSP1377
5.2.4 Accessories
Mobile conversion kit MSP1147
Foot-switch conversion kit MSP1152
Bedside kit MSP1153
6. TECHNICAL SPECIFICATION
6.1 General Dimensions
375
210 260 210 220
SA 14 and SA 16 All Models
Vacuum: 650mmHg*
Standard supply voltages available: 220V-250V 50/60 Hz 1ph 110V-120V 50/60 Hz 1ph
Electric motor classification: BS2757 Class B (insulated). Auto reset thermal cut out
*Vacuum measurements are quoted at sea level, and flow rates are taken at the filter point.
** SA 12 and SA 15 Options
ǂ SA 14 and SA 16 Options
IMPORTANT INFORMATION
Correct disposal of the product in accordance with EC directive 2012/19/EU
At the end of its life, the product must not be disposed of as urban waste.
It must be taken to a special local authority differentiated waste collection centre or to a dealer
providing this service.
6.3 Electromagnetic Compatibility (EMC)
Special Instructions / Notes regarding the SA unit and Electromagnetic compatibility (EMC) testing to
EN60601-1-2: 2014
The SA unit has been tested regarding its ability to operate in an environment containing other
electrical/electronic equipment (including other medical devices).
The purpose of this testing is to ensure the SA unit is not likely to adversely affect the normal
operation of other such equipment and that other such equipment is not likely to adversely affect the
normal operation of the SA unit.
Despite the testing of the SA unit that has been undertaken, normal operation of the SA unit can be
affected by other electrical/electronic equipment and portable and mobile RF communications
equipment.
As the SA unit is medical equipment, special precautions are needed regarding EMC
(electromagnetic compatibility).
It is important that the SA unit is configured and installed/put into service, in accordance with the
instructions/guidance provided herein and is used only in the configuration as supplied.
If the SA unit is used with cables / accessories other than those supplied, this may result in
increased emissions or decreased immunity of the SA unit in relation to EMC performance.
It should be noted that cables / accessories provided with the SA unit should not be used on other
equipment. To do so may result in increased emissions or decreased immunity of the other
equipment in relation to EMC performance.
The SA unit should not be used adjacent to or stacked with other equipment. If adjacent or stacked
use with other equipment is necessary, the SA unit and the other equipment should be
observed/monitored, to verify normal operation in the configuration in which it will be used.
The user should be aware that if the SA unit is subject to electromagnetic interference in the form of
electrical fast transients/bursts (IEC61000-4-4), electrostatic discharges (IEC61000-4-2) or conducted
/ radiated RF interference (IEC 61000-4-6 / IEC61000-4-3), incorrect operation of the SA unit may
occur. This could cause the vacuum to stop
7. NOTES
Portable Suction
Oxygen Flowmeters
Pipeline Regulators