FSR425 Operating and Maintenance Instruction Manual Issue 7 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: info@gablermedical.com EC

REP

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

All products manufactured by Gabler Medical (Pty) Ltd. carry a five-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 five (5) years 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

Notes

Contents Page No:

General Description

1

Instructions for use

2

Cleaning, maintenance and sterilisation

3

Testing of the suction controller

4

Recommended spares

5

Component diagram

6

Accessories

7

Specifications

7

Fault finding

8

Environmental protection

8

General Description FSR425

High Vacuum Suction Controller complete with colour changing disposable hydrophobic filter.

Intended Use The suction controllers are lightweight compact units used to vary the vacuum levels of a continuous vacuum source, within the stated operating vacuum range, for the aspiration of fluids and particulate matter in medical procedures carried out by clinically trained and authorized personnel.

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 controller, read all sections of this manual carefully. There are safety considerations that should be read and understood before use.

WARNING Chest drains, suction catheters and other end-pieces should not be connected directly to the suction controller but must be connected in conjunction with the collection jar.

WARNING Do not use this device in the presence of flammable anaesthetics. Static charges my not dissipate and possible explosion hazard exists in the presence of these agents.

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Instructions for use For correct and effective use of the FSR425 Suction Controller, these instructions should be read before use.

Secure the suction controller in its intended mounting position. Either rail, wall or directly mounted into the pipeline vacuum outlet. Insert the vacuum probe into the relevant wall outlet point. Connect the silicone tubing between the outlet of the controller and the vacuum connector of the collection jar. Attach the patient tubing to the patient connector on the collection jar. From the OFF position, turn the knob, on the side of the controller, 180 degrees anticlockwise to the ON position. To avoid damage, do not force the knob past the stopping points. Turn OFF by turning the knob 180 degrees in the clockwise direction.

Turning the controller ON

Set the vacuum required to the desired level by adjusting the control knob, on top of the suction controller. The level of vacuum will be indicated on the precision gauge marked 0 to -100kPa and 0 to -760mmHg. Note that the source vacuum pressure will impact the maximum achievable vacuum of the controller.

Silicone tubing to be used in conjunction with these suction controllers should have an inside diameter of 6mm with a wall thickness of at least 2mm.

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Cleaning, maintenance and sterilisation To clean the suction controller, simply wipe with a damp cloth and/or a mild disinfectant solution or 5% alcohol solution. No further cleaning or sterilisation is required. The suction controller should be inspected regularly and any damaged components should be replaced. All components on the reusable autoclavable collection jars, used as accessories to these devices, as well as the “O” rings should be disinfected by a machine wash at 85 oC and/or sterilized in a standard high temperature autoclave at 138oC.

WARNING Do not use alkaline or solvent-based detergents for cleaning and disinfection of this equipment.

WARNING This equipment is cleaned by wiping with a mild detergent. It is not suitable for autoclaving, with the exception of the collections jars and does not require sterilizing. Should sterilization be desired for any reason these devices may be sterilized by means of exposure to ethylene oxide gas. Functionality Check The suction controller is routine maintenance free however it is good practice to ensure the controller is functional especially if fitted in areas of low usage. Every 3 months perform a visual inspection and performance test: • Leak test – While ON at maximum vacuum, occlude the unit. Turn to the OFF position. Note the vacuum needle. It should not move at all indicating a perfect seal or drop very slowly. See fault finding section for remedies. • ON and OFF function – The ON/OFF function can be checked by occluding the unit while in the OFF position and checking if a vacuum is present. If no vacuum is present the OFF function is properly functioning. • Vacuum regulating function – While ON and the control knob is turn down to no vacuum, occlude the unit and gradually turn open the control knob. Open and occlude repeatedly the unit and observe the vacuum pressure increase while opening the control knob. Hydrophobic Colour Indicating Filter The suction controller is fitted with a white hydrophobic filter unit. This prevents liquids or solids from being inadvertently sucked up into the controller. Should the filter come in contact with liquid, the filter will automatically shut down the suction. The filter will change colour to pink for visual confirmation of liquid contact.

The filter element changes to pink when in contact with liquids

As little as 5ml will be enough to totally close the suction. If this occurs replace the filter immediately. This filter does not need changing frequently if not contaminated or occluded. Pink spotting may be evident if condensation occurs. If the suction controller is not in constant use, the recommendation is that in low usage areas, the filter should be changed every other functional check period and in high usage areas at least every check period.

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Testing of the suction controller Leak testing Below are the instructions to test vacuum leaks inside the suction controller. 1. Connect the suction controller to the vacuum source turn on and open the control knob to maximum. 2. With a length of tubing connected to the filter inlet and collection container (assuming the container is leak free). Occlude the patient port of the collection container and observe the vacuum pressure on the gauge increase to its maximum. See image guide below. 3. While the port is occluded, turn the on/off knob to the closed position. 4. Observe the behaviour of the vacuum gauge needle. 5. If the needle remains in positions or drops very slowly then the suction controller is properly sealed. If the needle drops very rapidly then there is a leak. See point 5 in the fault finding section.

Occlude patient port

On/Off knob seating If the onoff knob has been repositioned or the grub screw tightened, the on/off spindle will need to be seated to achieve optimal flow through the controller when open. 1. Unscrew the grub screw and remove the on/off knob. 2. Connect the suction controller to a vacuum source and occlude the inlet. 3. With pliers, turn the brass spindle clockwise until there is no vacuum reading. Pulse the inlet open and occluded to check the vacuum pressure while turning the spindle. The spindle should be in a position where it is “just closed” (no vacuum reading). 4. Place the on/off knob on the spindle pointing toward the off position. The pointer should be in a position where it has about 2mm travel between the pointer and the stopping pin. See image guide below. 5. Fasten the grub screw in this position so when the knob is turned to touch the stopping pins the spindle is well sealed in the off position.

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Recommended spares FSR425 Suction controller component and spares list Item No.

Part No.

Name

1

BIF035

Filter, hydrophobic colour indicating (Pack of 10)

2

BLF097-20

Brass hexagonal nut (Pack of 20)

3

BLF122-20

Washer (Pack of 20)

4

BLF172-5

Grub screw (Pack of 5)

5

BLF215-20

Screw (Pack of 20)

6

BLG102

Vacuum gauge, high

7

BLL208

High vacuum label

8

BLR234-10

"O" Ring (Pack of 10)

9

MEM529

Diaphragm

10

MEM601

Body, high/low

11

MEM605

Top

12

MEM609-5

Control knob (Pack of 5)

13

MEM621-5

ON/OFF knob yellow (Pack of 5)

14

MEM633

Cover yellow

15

MER161-20

Brass flat washer (Pack of 20)

16

MER365-5

Suction controller spacer (Pack of 5)

17

MER375

Adjustment bush

18

MES045

High vacuum controller spring

19

MIS325

Switch spindle assembly

Tools required for disassembly and reassembly 1. 2. 3. 4. 5.

T6 Star (Torx™) screwdriver (for removing cover and top) 2mm hex key (for ON/OFF knob grub screw) 4mm and/or 5mm hex key (screws mounting the probe at the rear of the controller) Flat screw driver (for lifting the control knob) Pliers

5

Component diagram Disassembly sequence: 1. The spindle (19) can be removed by loosening the grub screw (4) and removing the ON/OFF knob (13). The spindle can now be unscrewed using pliers. 2. Open the control knob (12) to maximum and remove by gently lifting at the notch using a flat screw driver to lift. Avoid damaging the clips. 3. Turn the adjustment bush (17) closed to relieve spring tension and lower its height. 4. Loosen the 4x star screws (5) securing the cover (14). 5. Remove the gauge by turning the face anticlockwise by hand. 6. Unclip the cover on the underside and remove. 7. Loosen the 4x star screws fastening the diaphragm and top to the body (10) . 8. Remove the top and diaphragm assembly. 9. The adjustment bush can now be turned out of the top. 10. Loosen the brass nut (2) to disassemble the adjustment assembly. Reassemble in reverse order. 12

5 11 5 3

2 15 18 17 16 9

14

10 8 19 4 13 6

1 6

Accessories

BLH031-5

Clear Medical Grade Silicone Tubing (5m roll) I.D 6mm O.D 11mm

FSP795-110000

1.5 Litre Autoclavable polysulfone collection jar, complete with cap assembly and overflow safety valve.

FSP795-120000

2 Litre Autoclavable polysulfone collection jar, complete with cap assembly and overflow safety valve.

FRB209

Female straight slide to mount FSP795 collection jars to walls or surfaces

Specifications Standard Size (without probe or fittings) Mass GMDN code Class

ISO 10079-3 150mm (H), 75mm (W), 90mm (D) Approximately 470g (with direct probe) 36778 CE classification: Class I South African classification: Class B

Vacuum Gauge type Vacuum Gauge range

Bourdon tube Dual scale: 0 to -100kPa, 5kPa increments 0 to -760mmHg, 25mmHg increments +/-1.6% of full scale Integrated, non-mechanical, colour indicating hydrophobic filter ABS Silicone Ultra-High Molecular Weight Polyethylene (UHMW-PE) SABS, BS, 1/8” NPT socket Any medical vacuum probe configuration can be provided on request

Vacuum gauge accuracy Contamination protection Enclosure material Diaphragm and seal material Filter element material Vacuum probe connection

7

Fault finding Assuming instructions for use have been followed: No. Fault

Cause

Remedy

1

No suction

Problem with vacuum source or probe connection

Check vacuum probe connection and vacuum source

2

No suction

Kink or blockage in tubing

Free tubing from possible kinks, check for blockages

3

No suction

The filter is blocked with fluid

Check filter colour. Change filter is blocked with fluid

4

No suction but on/off knob turns

On/off knob is loose on the spindle

Retighten the grub screw with 2mm allen key. Check the knob is in the correct position when retightened

Leak in the suction controller

Check for cracks in the unit. Contact the seller or Gabler Medical for repair. Check for a good seal with filter. Reposition O-ring or replace filter.

5

Low vacuum pressure

6

Low flow rate

ON/OFF knob not fully open

Check ON/OFF knob is in the ON position. Loosen the grub screw and reposition if not fitted correctly in step 4

7

Control knob loose

Damage to control knob

Contact Gabler for spares and replace with PN MEM609-5

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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