FSE550-111021 Operating and Maintenance Instruction Manual Issue 4 March 2023

Gabler Medical (Pty) Ltd 22 Thor Circle Viking Place Thornton South Africa Telephone: +27 (0)21 531 0820 Fax: +27 (0)21 531 0829 Email: [email protected]

Advena Limited Tower Business Centre, 2nd Floor Tower Street Swatar BKR 4013 Malta www.advenamedical.com

All products manufactured by Gabler Medical (Pty) Ltd. carry a one-year warranty against faulty materials and workmanship. Warranty claim equipment should be returned to the manufacturer as soon as possible after detection of a problem.

This warranty is limited to twelve (12) months from the date of original delivery. The warranty provided herein shall be void and of no effect in the event that (a) the product has been subjected to misuse, neglect or improper / inadequate maintenance (b) unauthorized modifications are made to the product (c) the product has been opened and the internal mechanism tampered with in any form

Gabler Medical (Pty) Ltd. reserves the right to make changes without notice in design, specifications and models. The only warranty Gabler Medical makes is the express written warranty extended on the sale of this equipment. The information in this manual is confidential and may not be disclosed to third parties without the prior written consent of Gabler Medical (Pty) Ltd.

Contents Page No:

General Description

1

Instructions for Use

2

Cleaning, Maintenance and Sterilization

3

Cleaning, Maintenance and Sterilization (continued)

4

Cleaning, Maintenance and Sterilization (continued)

5

Collection Jar with Overflow – Servicing Procedure

5

Recommended Spares

6

Specifications

6

Wiring Diagram

7

Collection Jar Diagram

8

Safety Symbols

9

Environmental Protection

9

General Description FSE550-110021

A general purpose High Vacuum / High Flow portable medical suction unit with two collection jars and fitted with a changeover switch to alternate between collection jars. . This unit is not intended for field or transport usage.

WARNING Only suitably skilled and trained staff should make use of this equipment. This equipment should only be used on the recommendation of a physician.

WARNING Before making use of this suction equipment, read all sections of this manual carefully. There are safety considerations that should be read and understood before use.

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Instructions for Use Before operating the FSE550-110021 suction unit, please read the following instructions.

1.

Place the FSE550-110021 unit on a firm level surface close to the patient and within 2.5 metres from a 220/240V AC power supply source. Plug the unit in and switch the electrical supply point on.

2.

Remove the plastic dust bag from the collection jars.

3.

Ensure that the jars are correctly screwed into the caps and replace the collection jars in the bottle holders on the side of the unit.

4.

Connect a suitable catheter to the end of the silicone tubing from the patient connector of the collection jar which is to be used initailly.

5.

Switch the unit on by means of the “MAINS” on/off switch, press “I" for ON and “0" for OFF. The green neon lamp in the switch should be illuminated, indicating that the unit is ON and ready for use.

WARNING The suction unit should never be started up against a vacuum. Should the operator erroneously start the unit up against a vacuum, the fuse will blow protecting the motor from further damage.

6.

To achieve the desired degree of vacuum, occlude the tube fitted to the patient inlet of the collection jar and operate the vacuum control valve until the desired degree of vacuum is achieved. This will be indicated on the precision gauge marked 0 to -100kPa and 0 to -760 mmHg.

7.

Both the collection jars are fitted with a safety overflow system. If the jar fills to its maximum capacity with fluid, the overflow float will be sucked onto the overflow valve in the cap causing the suction to stop. (This mechanism prevents fluid from entering the motor.) If the unit is not switched off at this point, and the motor is running for a long period working against this closed off vacuum, the motor could be damaged. Switch the unit off or select the alternate collection jar and then empty the full collection jar. Suctioning may now be resumed. The overflow cage and float must always be fitted in the collection jar when the suction unit is being operated in order to prevent the overflow of fluids into the motor.

8.

The suction unit is fitted with a changeover switch, which enables the user to alternate between collection jars with minimal interruption of suctioning.

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Cleaning, Maintenance and Sterilization Cleaning / Disinfection To clean the outside of the FSE550-110021 unit simply wipe with a damp cloth or a mild disinfectant solution. Do not use alkaline detergents or solvent based cleaning agents, and avoid contact with excessive moisture. All components on the collection jar, as well as the filter connectors and “O” rings should be disinfected by a machine wash at 85oC and/or in a standard high temperature autoclave, with a maximum temperature of 121 oC. WARNING Do not use alkaline or solvent-based detergents for cleaning and disinfection of this equipment. CAUTION Do not allow liquids to seep into the interior of this suction unit. Do not use caustic or abrasive detergents. Do not use acetone, alcohol or other solvents to clean this equipment. Do not immerse this equipment or any of its components in any liquids.

Daily Maintenance 1.

The air filter is a sealed disposable capsule and is fitted between the filter outlet and the vacuum connector on the collection jar. The filter capsule is moulded in high impact polystyrene and encapsulates a bonded micro glass fibre disc. The 0.3 micron particle retention of the filter medium gives not less than 99.985% D.O.P. and provides an effective barrier against contamination. In accordance with ISO 10079-1 it is recommended that the filter capsule be changed after each day’s use, or immediately if it becomes wetted by froth, or after aspiration of any infective material.

2.

An anti-foam agent may be put into the collection jars before use, to prevent the possibility of frothing. It should not however, be placed into the jars for extended storage periods.

3.

Examine the collection jars and external tubing for ageing or damage and replace if necessary. Use silicone tubing with an ID of 6mm.

Monthly Maintenance 1.

Check the vacuum and flow at the filter intake.

2.

With the liner empty and the vacuum control set to achieve maximum vacuum, switch on the unit and check the indicated vacuum on the vacuum gauge. Occlude the suction inlet of the liner and note the time taken to indicate an increase of 500 mmHg. This time should not exceed eight seconds. The gauge should continue to rise until the maximum vacuum is attained (not less than 600 mmHg).

Annual Maintenance 1.

2.

The suction unit should be opened annually by a suitably qualified technician. The interior of the unit should be inspected for any deterioration of the silicone tubing or wiring due to ageing. The motor/pump is a maintenance free unit and should only be dismantled by a factory trained technician.

WARNING Disconnect Electrical Power Always switch off the power and disconnect the mains cable before opening this equipment.

3

Cleaning, Maintenance and Sterilization (continued) Fault Finding If the unit will not start after being switched on, carry out the following steps:• Check electrical supply. • Check fuses. • Check the electric lead and plug top for a broken connection. If the fault has not been rectified after these checks, the unit should be opened by a suitably qualified person for further inspection. WARNING The suction unit should never be started up against a vacuum. Should the operator erroneously start the unit up against a vacuum, the fuse will blow protecting the motor from further damage.

Testing For Leaks If the unit is switched on and the motor is running, but there is weak or no vacuum indicated when the vacuum outlet is closed off, the following steps should be carried out to determine where the leak exists: 1.

Check that the vacuum control knob is fully closed by turning in a clockwise direction.

2.

If there is little or no vacuum, remove the filter and tubing from the unit and close the filter adapter hole with your finger.

3.

The vacuum gauge should now show approximately -80kPa which will indicate that the pump/motor is fully operational. (The vacuum achieved will depend on the altitude at which the unit will be used.) If you have determined that the pump is fully operational, it is now necessary to determine where the leak exists. The vacuum performance can be affected by: Leaks caused by cracks in - bottle - cap - connectors - filter unit. Damage to

- silicone tubing - liner - filter unit

4.

Inspect the filter for cracks or damage. Examine the silicone tubing for damage. Replace parts as necessary. Connect the filter with tubing back onto the filter adapter.

5.

Remove the angle tube connector marked “VACUUM” from the cap of the collection jar. Check for damage and replace, as necessary. Close off the angle tube connector to create a vacuum. The vacuum gauge should again read approximately -80kPa when this connector is closed. This will indicate that there is no leak thus far in the system.

6.

Fit this connector back in the cap. Close off the angle tube connector marked “PATIENT” to test the collection jar for leaks.

7.

If a vacuum of approximately -80kPa is still not indicated on the vacuum gauge, follow the following steps: • Unscrew the bottle from the cap. Check the bottle for damage and replace as necessary. • Remove the sealing ring from the groove in the underside of the cap. • Check the sealing ring and cap for damage and replace as necessary. • Unscrew the overflow cage from the cap. Remove the overflow float. • Check that the overflow rubber valve is in place. Remove if necessary to check for damage. • Replace if necessary.

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Cleaning, Maintenance and Sterilization (continued) 8.

To re-assemble the collection jar: • • •

• • •

Fit all angle tube connectors and plugs back into the cap. Ensure that these are pushed down firmly into place. Fit the sealing ring back into the groove on the underside of the cap. Ensure that the rubber sealing ring is not twisted when it is replaced in the cap as this will definitely create leaks. The rubber sealing ring must be flat in the groove when the cap is screwed onto the collection jar. Fit the overflow rubber valve back into the cap. Return the overflow cage and float to the cap. Screw the jar into the cap.

9.

Connect the complete collection bottle to the silicone tubing from the suction unit.

10.

Close off the “PATIENT” angle tube connector to create a vacuum. The suction unit should now be fully functional, and the vacuum gauge reading approximately -80kPa.

Collection Jar with Overflow – Servicing Procedure Refer to the FSP795 collection jar assembly diagram and parts list. 1.

Unscrew the jar (No.1) from the cap (No.7).

2.

Unscrew the overflow cage (No.2) and remove the overflow float (No. 3).

3.

Remove the overflow rubber valve (No.4).

4. Remove the large angle tube connector (No.9) and tube connector extension (No.5) from the bottle cap (No.7). If necessary, separate the 2 parts. 5.

Remove the large plug (No.8) from the cap (No.7).

6.

Remove the sealing ring (No.6) from the groove in the underside of the cap (No.7).

7.

Examine all the disassembled parts of the collection bottle for damage. Replace as necessary.

8.

To re-assemble the bottle unit: • • • • • • • • •

Fit the small angle tube connector (No.10) into the middle hole marked “VACUUM” on the cap (No.7). Fit the large angle tube connector (No. 9) with the tube extension piece (No.5) attached, into the side hole marked “PATIENT” on the cap (No.7). Fit the large plug (No.8) into the unmarked hole in the cap. Ensure that all the connectors (No. 8, 9, 10 & 5) are pressed firmly into the cap to avoid the possibility of leaks. Place the sealing ring (No.6) into the groove on the underside of the cap (No.7). Make sure that the sealing ring lies flat in the groove. Press the sealing ring into the groove. Fit the overflow rubber valve (No.4) into the middle threaded hole on the underside of the cap (No.7). Place the overflow float (No.3) with “TOP” facing upwards, into the overflow cage (No.2). Screw the overflow cage (No.2) and float (No.3) into the middle threaded hole on the underside of the cap (No.7). Screw the jar (No.1) into the cap (No.7) ensuring that all the ridges on the top of the bottle are screwed securely into the cap.

5

Recommended Spares Suction Unit Spares SPARE COMPONENT DESCRIPTION

PART No.

Closed Bacterial Filter (pack of 10) Disposable Hydrophobic Filters (pack of 10) CP30 Pump 220/240V Switch Dust Cover On/Off Switch Panel Mounted Fuse Holder 0.8 Amp 20mm Glass Fuse (pack of 10) High Vacuum Panel Mounted 63mm Gauge Silicone Tubing (per metre) Exhaust Filter (pack of 10) Liner Filter to Bottle Connector with “O” Ring “O” Ring for Filter Inlet Connector

BIF001 BIF013 BIP025 BLE317 BLE325 BLE401 BLE408 BLG021 BLH031 MIR214 BIJ053 MIS163 BLR271

Collection Jar Components Ref. No 1 2 3 4 5 6 7 8 9 10

DESCRIPTION Autoclavable Bottle, capacity of 1800ml Overflow Float Cage Overflow Float Ball Overflow Rubber Valve Tube Connector Extension Sealing Ring Cap Large Plug, 21mm diameter Large Angle Tube Connector, 21mm diameter Small Angle Tube Connector, 16mm diameter

PART NO. MEM111 MEM095 MEM099 MEM505 MEM142 MEM501 MEM091 MEM147 MEM132 MEM127

Specifications Power Supply:

220/240 Volt 50Hz

Fuse Type:

0.8 Amp (Slow Blow) 20mm Glass Fuse

Electrical Protection:

Type B, Class I as stated in IEC 60601-1

Free Air Flow (in litres per minute):

26

Performance classification:

High Vacuum High Flow (ISO 10079-1)

Power Input:

75 Watts

Regulatory Details & Standards ISO10079-1 EN60601-1 EN60601-1-2 WARNING Disconnect Electrical Power Always switch off the power and disconnect the mains cable before opening this equipment.

6

M

Wiring Diagram

7

Collection Jar Diagram

8

Safety Symbols

Symbol

Meaning Type B Applied Part

l

ON (Mains power on)

O

OFF (Mains power off) WARNING! Read carefully. Manufactured by Catalogue number for product Keep dry Authorized representative in the European Community Caution, consult the accompanying documents Serial No. When the last user wishes to discard this product, it must be sent to the appropriate facilities for recovery and recycling. This product and packaging materials should be recycled, if the regulating authorizes in the local community provide for its collection Danger! Electrical hazard Consult the instructions for use

Environmental Protection

Important! Separate collection This device must not be disposed of with normal domestic waste. Make this product available for separate collection or alternatively return this device to the manufacturer for disposal.

Important! Separate collection of used products and packaging allows materials to be recycled and used again. Re-use of recycled materials helps prevent environmental pollution and reduces the demand for new materials.

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