Ultrasonic Irrigator S2800 User Manual April 2020 V3.1.1

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Table of Contents 1. Introduction ... 1 2. Requirements ... 3 2.1. Environmental ... 3 2.2. Plumbing ... 3 2.3. Electrical ... 3 2.4. Machine Reporting System (MRS models only): ... 4 2.5. Machine Location ... 4 2.6. Printer (optional) ... 4 3. Installation ... 5 3.1. Plumbing ... 5 3.2. Electrical ... 5 3.3. Machine Reporting System (MRS models only): ... 6 3.4. Printer (optional) ... 6 3.5. Detergent ... 6 4. Operation ... 7 4.1. Prior to Operation: ... 7 4.2. How to Operate: ... 7 5. Foil Test ... 13 5.1. Performing a Foil Test ... 13 5.2. Foil Test Problem Solving ... 13 6. Keypad Description ... 15 7. Programmable Features ... 17 8. Program Mode ... 19 8.1. Program Entry Points ... 19 8.2. Program Parameters ... 19 9. Display Messages ... 21 10. Error Diagnosis ... 23 10.1. Program Values Lost: (FAIL) ... 23 10.2. Low Level in Tank: (LO) ... 23 10.3. Drain Blocked: (drnb) ... 24 soniclean.com.au [email protected]

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10.4. Overflow Detection: (OFLO) ... 24 10.5. Ultrasonics Overheating: (HOT) ... 24 10.6. Real-Time Clock: (rtc) ... 25 10.7. Power-up warning: (P-UP) ... 25 10.8. Water leak: (H2OL) ... 25 10.9. Setting default IP values. (IP-?) ... 25 11. Remote Diagnostics Interface ... 27 A. Cleaning Cannulated Instruments ... 29 A.1. Cleaning Process ... 29 A.2. Using your Soniclean S-2800 Ultrasonic Irrigator ... 30 A.3. After using your Soniclean S-2800 Ultrasonic Irrigator ... 30 A.4. Performance Testing ... 30 B. Operating Instructions Summary (Washer) ... 31 B.1. Typical Operation ... 31 B.2. Automatic Shutdown ... 31 B.3. Manual Shutdown ... 31 C. Specification ... 33 D. S2800/MRS Preventative Protocol (Recommended) ... 35 E. S2800/MRS Disinfection Protocol (Recommended) ... 37 F. Warranty ... 39 F.1. Warranty Registration ... 40 G. S2800/MRS Installation Checklist ... 41 G.1. For Technician ... 42 H. Further Enquiries ... 45

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1.

Introduction

Thank you for purchasing a Soniclean Ultrasonic Irrigator. Soniclean Irrigators are designed to improve the quality and consistency of cleaning for laparoscopic instruments using a combination of ultrasonics and irrigation. The Irrigator flushes cleaning solution through the cannulae of hollow instruments whilst delivering ultrasonics for a precision clean. The Irrigator is equally effective for cleaning non-cannulated instruments. It is intended that the instruments shall be gross-cleaned prior to loading into the Washer, and be sterilised in the usual manner after ultrasonic cleaning Soniclean provides two irrigator models: S2800 and S2800MRS. S2800MRS includes the addition of Soniclean's Machine Report System (MRS), enabling users to monitor performance of their machine(s) and logs data of each clean for future reference, printed via a dedicated printer (optional) or stored for electronic retrieval via an ethernet interface.

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2.

Requirements

Note: The customer shall ensure the following requirements are met prior to installation. This is essential for the machine to perform at optimum level and to fulfil Australian Standards. If the customer fails to provide this information, Soniclean will provide the information for a fee.

2.1.

Environmental

1. Use water with ambient temperature. 2. A tap or inlet must be dedicated to the Washer. 3. A drain outlet must be dedicated to the irrigator. 4. Water Quality for cleaning as per AS/NZS 4187:2003 shall be used. (Water hardness will determine the type of detergent to be used. It will also determine the amount of detergent to be used in the cleaner.)

2.2.

Plumbing

1. Maximum water pressure: 150 psi; minimum water pressure: 50 psi. 2. Flow rate 10 litres/minute (minimum) to 20 litres/minute (maximum). 3. This is a High Hazard application and the inlet mains supply shall be fitted with an approved Reduced Pressure Zone Device and a line filter. (Please check with your local Water Authority for the correct installation information for your area.) 4. Mains inlet connection with ½" male BSP fitting within 600mm from the machine. 5. Do not use any aeration devices in the mains water supply. 6. Outlet pipe of 25mm diameter for waste water within 600mm from the machine.

2.3.

Electrical

1. Wall power socket 240 VAC 50-60 Hz rated at 10 amps. 2. Wall power socket located within 600mm from the machine. 3. Power supply circuit shall not be shared with life threatening or life support electrical systems. 4. Power supply circuit shall not be shared with computer electrical system or other excessively large power devices, e.g. steriliser/washer disinfectors. soniclean.com.au [email protected]

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5. Earth leakage protection shall be provided by user. Note: The unit contains MOV surge arrestor – when carrying out insulation resistance test, MUST carry out test at 250v as per ASN/NZ3760:2003 (page 14) for Class 1 equipment with MOV surge arrestor.

2.4.

Machine Reporting System (MRS models only):

1. Local Area Network (LAN) outlet 1000mm from the machine.

2.5.

Machine Location

1. Place the machine on a flat and horizontal surface. Maximum tilt is 2º. 2. Position at operator's convenient height. Soniclean recommends the top of the lid be at elbow height. 3. The bench top shall be strong enough to support the fully loaded machine (approximately 60 kilograms). 4. The unit requires 590mmx 880mm of bench space. 5. Allow minimum 100mm clearance at the rear to enable plumbing access. This may be reduced by fitting elbows to both the inlet and the outlet. 6. Allow 1000mm clearance above unit to allow the lid to open fully.

2.6.

Printer (optional)

1. Allow room on the left hand side of the machine for the printer unit.

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3.

Installation

3.1.

Plumbing

Inlet Mains Supply 1. Screw supplied braided hose on to the machine and inlet mains water supply (hand tighten only). 2. Screw and hand tighten supplied grey sink hose onto the machine and insert into drain. 3. Ensure that the drain hose falls evenly away from the machine to the drain. Outlet Waste Supply 1. Screw and hand tighten supplied black sink hoses onto the machine and insert into drain. 2. Ensure that the black sink hoses fall evenly away from the machine to the drain.

3.2.

Electrical

1. Plug machine into mains supply. Socket is on RHS of unit near rear. 2. Switch on when ready to operate. Note: The unit contains MOV surge arrestor--when carrying out insulation resistance test, MUST carry out test at 250v as per ASN/NZ3760:2003 (page 14) for Class 1 equipment with MOV surge arrestor.

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3.3.

Machine Reporting System (MRS models only):

1. LAN connection; take the LAN cable provided and push the black plug into the MRS socket provided on the Irrigator. Plug the other end (RJ45) into the LAN wall outlet. 2. Contact your IT department and hand them the Machine Reporting Manual. The appropriate information for connecting the machine to the Local Area Network is found on page 10 "Network Hardware and Configuration" of the Machine Reporting System Manual. 3. PC Connection direct (no LAN): take the PC cable provided and push the black plug into the MRS socket provided on the Irrigator. Plug the other end (RJ45) into the appropriate outlet on the PC. Caution: Only use designated cables for accessing data from the Washer. The cable marked `PC' should be used for direct connection to computers ethernet port . The cable marked `LAN' should be used for connection to a LAN wall outlet.

3.4.

Printer (optional)

1. Plug the machine into mains supply and turn on at the switch. 2. Plug the printer cable into the machine and the printer. 3. Press the feed button to progress the paper.

3.5.

Detergent

1. Connect detergent hose to left hand side socket of machine. 2. Place filtered end of detergent hose into container. 3. Ensure there is sufficient detergent in bottle at all times.

Please note Chemical Type:

(Sonic 1), Dosage Setup:

(0.5%)

(Soniclean Sonic 1 is a TGA listed and hospital grade medical alkaline detergent concentrate formulated for use with this ultrasonic irrigators.)

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4.

Operation

4.1.

Prior to Operation:

Position machine on bench top or table. Ideally the lid of the machine should be at elbow height. Ensure the machine is horizontal and the water inlet tap is turned on.

4.2.

How to Operate:

Start Process 1. Turn on at power point. 2. The machine will display 8.8.8.8, then SCx.x 3. The machine will automatically, drain, flush, drain the flush, fill with water and detergent and perform a de-gassing cycle. 4. When the degassing cycle is complete, the machine is ready for use. 5. During the above cycle, the machine with display the following: Display

Function

8.8.8.8

Internal program.

SCx.x

Internal program process.

Drn

Draining the water.

Drnf

Tank is flushing. (Drain is open.)

Drn

Tank is draining the flush.

FILL

Tank is filling with water and detergent is automatically added at the programmed quantity. (0.5%)

De-gas

The solution is degassing. (This takes approximately 10 minutes.)

----

The machine is ready to be loaded with instruments.

6. It is recommended that you perform a foil test daily to check the performance of your Washer. (Refer Section 5, Foil Test.)

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Confirm Parameters To check or change the settings or parameters of your Irrigator: 1. Press the "Shift" and "Program" keys together and hold for 3 seconds. 2. Beep will sound when command has been recognized. 3. The machine will display the "Clean Time" or "ct". 4. Scroll through the parameters using the "Enter" keys. 5. The parameters may be changed as required. (Refer Section 7, Program Mode.)

Loading the Machine Refer to Appendix A (“Cleaning Cannulated Instruments”) for suggestions about the care of your laparoscopic instruments. 1. Instruments may be loaded into tray with the tray located in the Irrigator tank, inside the machine, or resting above the bath. (Use the "T" handle on the tray to position tray above bath). 2. Dismantle the instruments and insert the nozzle end of the cannulated instrument (standard sizes 2, 5 and 10mm) into the connector provided. 3. With the ports vertical, place the connector, with instrument loaded, into the port. 4. Gently lay the instruments down and rest them on the moveable plastic rack. Adjust the rack to support the instruments. The other parts of the instruments may be placed on the bottom of the tray or in the instrument holders provided. 5. The unused ports should be left in vertical position (when the Irrigator function is turned off to that port). 6. Lower the tray into the cleaning bath. (Ensure the "T" handle is on the right hand side). 7. Ensure that the spigot in the bath docks onto the instrument tray. Note – with twin manifold baskets it is important to load the lower of the two manifolds first with the lower of the two instrument supports in place. The taller of the instrument supports can now be fitted and the higher manifold can be loaded.

Start Cleaning Cycle 1. Close the lid and press "CLEAN". 2. The machine will perform a cleaning cycle according to its program.

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3. The following table explains the various parameters of the clean function, which are displayed during cleaning and are programmable to suit your requirements. Cleaning Activity

Display

Parameters*

Explanation

Clean No.

C-01

10

Current clean cycle no.

Ultrasonics

P-03

3

Displays power level.

Time Remaining

09.48

10 minutes

Time remaining to complete current clean. **

* As set by the manufacturer. ** Displayed in minutes and seconds (mm:ss).

Pause Cleaning Cycle 1. Lift the lid to pause the cleaning cycle. 2. This feature allows for any adjustments the instruments may require.

Stop Cleaning Cycle 1. Press "CLEAN" again during cycle. This will stop the cycle and clear current clean. 2. To start new cycle, press "CLEAN" again.

Completion of Single Clean Cycle 1. The machine will emit five (5) beeps and display `----'. 2. Lift the lid. 3. Raise the instrument tray and rest it above the bath using the `T' handle.

Automatic Drain and/or Shutdown The Irrigator can be programmed to automatically drain after a selected number of cleaning cycles. 1. Manufacturer's programmed number of cleans between draining is ten (10). 2. When the tenth clean cycle is completed the machine will display "END". 3. The tank will automatically drain.

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Irrigation 1. To turn on, press the "Irrigate" key. The machine will irrigate as programmed. 2. To stop irrigating, press the Irrigate key again.

De-gas Function 1. The machine will automatically de-gas as programmed when started. 2. If further de-gassing is required, press the "DEGAS" key. 3. The red indicator light will light, indicating the machine is de-gassing. 4. To stop de-gassing, press the "DEGAS" key again, the red indicator light will extinguish, indicating the machine has stopped de-gassing.

Draining the Tank 1. i. Press the "SHIFT" key and "DRAIN" key together and hold for three (3) seconds. 2. ii. The machine will emit a beep. 3. iii. Release the keys and the machine will drain. 4. iv. When drain complete display will show "off".

Draining and Refilling the Tank 1. Press the "SHIFT" key and "REFILL" key together and hold for three (3) seconds. 2. The machine will emit a beep. 3. Release the keys and the machine will drain and then refill with water and detergent and perform degas cycle.

Manual Shutdown Procedure This enables the machine to be shut down at any time. It is recommended that this procedure be done at the end of each day. 1. Press "SHIFT" and "DRAIN" together, and hold for 3 seconds. 2. The machine will drain. 3. The machine will display "OFF". 4. Turn off the power at the power point. soniclean.com.au [email protected]

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5. Wipe down surfaces of machine with detergent or disinfectant.

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5.

Foil Test

Tip: Remove tray to ensure foil test is accurate.

5.1.

Performing a Foil Test

1. Complete the usual start process. 2. Use a strip of `home' brand aluminium foil about 150mm long x width of roll 3. Suspend foil from wire stretched between tray handles. 4. Press TEST Key to switch on ultrasonic and unit will run for 30 sec as programmed. 5. Remove the foil and compare the number and distribution of perforations with the sample foil test provided with your machine. Refer Australian Standard AS/NZ 2773.1-1998, page 16 for more details. NOTE: It is important to always use the same type of foil. It is suggested that a test is performed, on receipt of the machine, of such duration as to give a result similar to the sample provided. This will then become the foil test time for that type of foil.

5.2.

Foil Test Problem Solving

If you are having difficulty getting a foil test to perform to standard, work through the following items, then try foil test again.

Machine may require further degassing. 1. Remove any load from the machine. 2. Press "DEGAS" to degas the machine.

Detergent Type and Dilution Tip: Check detergent bottle is full, check that same brand is being used, and check bottle and hose are connected and that there are no kinks in the line. 1. Always use a pH neutral or slightly alkaline detergent (pH 8 to 10.8) that is made specifically for ultrasonic machines. 2. Extra detergent may be added to overcome water quality issues.

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Contact your service agent if you cannot achieve a satisfactory foil test. N.B. As per AS/NZ 2773.1-1998, it is acceptable to use alternative methods of testing the performance of your ultrasonic machine. Examples such as aluminium disc and pencil test, Soniclean Ultrasonic Performance Meter (UPM) must be used as per manufacturer's instructions.

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6.

Keypad Description

Item

Function

1.7 segment display

Provides feedback, incl. error messages, clean status, etc.

2. Irrigate (

Initiates irrigation.

)

3. Clean Values (

)

Program (secondary) 4. Up ( )

Initiates "program" mode, enables user to change operation parameters. Increases values in "program" mode.

Shift (hold) 5. Enter (

Lid is being raised.

)

Drain (secondary) 6. Down ( )

Secondary function key. Hold, then press required key, eg. Drain. Comfirms changes to parameters in "program" mode. Initiates machine in "operate" mode. Drains machine (press while holding shift). Decreases values in "program" mode.

Refill (secondary)

Drains machine, then refills with fresh water. (press while holding shift).

7. Test

Tank is draining the flush.

8. De-gas ( )

Removes gas from solution. Press again to cease degassing.

9. Clean (

)

Reset (secondary)

The solution is degassing. (This takes approximately 10 minutes.) Immediately aborts current operation (press while holding shift).

Program

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7.

Programmable Features

When you receive your Soniclean Washer it will be set to function automatically. The parameters are set in the factory. The features described below may be altered as you require. The list includes the display you will see on the machine when you are programming. Parameter

Description

Ct

Length of cleaning times.

PO

Ultrasonic power levels.

Cn

Clean number. This determines the number of cleaning cycles your machine will perform before automatically draining.

F°

Wash fill temperature.

SP

Detergent concentration.

G1

Start up degassing time.

G2

Pre-wash degassing time.

tt

Test time. Set time for foil test.

Id

Irrigation default - 1= irrigation on at start up.

Ir

Number of (5 second) rest periods between flushes.

To alter these parameters see Section 8, “Program Mode”.

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8.

Program Mode

The parameters can be altered by entering the program mode; there are three (3) methods to enter this mode.

8.1.

Program Entry Points

Alternative 1 Program at Start Up 1. Press the "Clean Values" key then turn on the machine. 2. Hold the "Program" down until the machine displays "Ct.nn". 3. Release the "Program" key.

Alternative 2 - Program during Operation 1. The machine will display "- - . - -". 2. Hold down the "SHIFT" key and then press the "Program" key and hold for three (3) seconds.

Alternative 3 - Program during Operation 1. The machine will display "- - . - -". 2. Hold the "Program" key for three (3) seconds. 3. Ct, PO & rt parameters may be reset. 4. Values will be held until changed or until machine is restarted.

8.2.

Program Parameters

To program the parameters, enter program mode per 7.1 above, then: 1. The machine will display a variety of parameters that you may reconfigure. 2. Press the arrow "UP" key to increase the parameter and the arrow "DOWN" key to decrease the parameter. 3. To accept a value press "ENTER". The display will scroll through the parameters. 4. Refer the table on the next page for parameters and default values.

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Default Parameter Values i.

Key to Programming Display Parameter

Display

Unit

Min

Max

Default

Clean time.

Ct

mins

1

99

5

Ultrasonic power level.

PO

1

6

3

Clean number.

Cn

0

99

10

Detergent concentration.

SP

%

0.0

5.0

0.5

Start-up degas time.

G1

mins

0

99

5

Pre-wash degas time.

G2

mins

0

99

1

Test time.

tt

sec

0

99

30

Irrigation default.

Id

0

1

1

Irrigation rest periods.

Ir

1/per 5 sec 5

50

5

To alter these parameters see Section 8, “Program Mode”.

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9.

Display Messages

These messages are displayed on the keyboard at various times. This table explains their meanings. Display

Explanation

----

Together with 5 beeps indicates that a process has been completed. (The operator does not need to wait for the beeps to complete before starting another process.)

04:58*

Shows the time remaining of the function that is currently operating, i.e. clean/degas.

C-01*

Indicates the current cleaning cycle number.

P-03*

Indicates power level selected, e.g. P-02, P-03, etc.

dGAS

Indicates the machine is de-gassing.

drn

Machine is draining.

drnf

Bottom of the wash tank is flushed with clean water, and then drained.

FILL

The machine is filling the wash tank.

OFF

The machine has completed operation and needs to be turned off at power point.

END

End of final clean.

tESt

When the lid is open to maintain ultrasonic (foil/UPM) performance test.

Drnb

This indicates sensors detect liquid when wash tank supposed to be empty.

FAIL

Indicates that the operator programmed values have been lost and will need to be re-programmed.

HOT

Indicates an excessive heat condition.

LO

Indicates a low level in the wash tank.

OFLO

Indicates that liquid has been detected in an area of the machine that should always be dry.

rtc

Indicates the Real Time Clock (RTC) date/time in the system is considered invalid. (MRS function only.)

P-UP

Indicates a clean process was interrupted and did not complete the full cycle.

H2OL

Indicates a water leak in the system or circuit/wiring failure.

IP-?

Indicates the configuration of the machine is not known. (MRS function only.)

SLid

Lid has been opened during operation.

N.B. Displayed when cleaning. soniclean.com.au [email protected]

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