Sonic Irrigator SA User Manual Rev J

User Manual ®

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Section 1 : Introduction Rev.J

Corporate Branding

Medisafe International, Twyford Road, Bishop’s Stortford, Hertfordshire CM23 3LJ, U.K. T: +44 (0)1279 461641 F: +44 (0)1279 461643 www.medisafeinternational.com E:[email protected]

Ref: UM SI-SA 3 03/11 Rev.J

3

Section 1-1 - Memorandum of Registration

User Manual

THIS MANUAL IS VALID ONLY FOR MEDISAFE SI-SA ULTRASONIC IRRIGATORS MANUFACTURED AFTER MARCH 1ST 2004 (SERIAL NUMBERS COMMENCING 0304) Note to Person Installing this Product This Memorandum of Registration MUST be completed by the person undertaking installation and witnessed by the owner of the product. Note to Owner of this Product Be sure that this Memorandum of Registration is completed by the person undertaking to install the product. In the event of a Warranty Claim the information contained within this Registration is your evidence that the product has been correctly installed. Important Note: Failure to provide this evidence in the event of a warranty claim may result in the claim being rejected (this does not affect your statutory rights as a customer).

Owner’s Name:

Installation Address:

Installation Date:

Serial Number:

Software Version:

Installed by:

Witnessed by:

Service and Maintenance Requirements: The Medisafe SI-SA Sonic Irrigator should be serviced on a regular basis to ensure that the product continues to perform in accordance with its design parameters. See page 33 for further information.

Ref: UM SI-SA 4 03/11 Rev.J

4

Section 1-2 - Trained Personnel

User Manual

The owner of this equipment has the responsibility for giving training and keeping records of training to the user. The following table can be used for keeping training records

Date

Ref: UM SI-SA 5 03/11 Rev.J

Name

5

Signature

Section 1-3 - Important Information

User Manual

Product Identity

Decontamination: This product MUST be decontaminated in accordance with local regulations before transporting. In the event that the product must be returned to the supplier, it is vital that the Decontamination Certificate (Section 4-6) of this manual is completed and returned with the product.

The model and serial number are located on the silver label to the rear of the unit. They can also be viewed on the printer attached to the machine. The model number can also be viewed from the Front Panel LCD Display for a 5 second period when the unit is first switched on.

Intended Purpose: The product is not suitable for use with flammable materials or gases and should not be used for any purpose other than that defined by the manufacturer as the Intended Purpose (Section 1-5).

Electrical The power cord and connector supplied with this machine are wired according to the following colour code: BLUE BROWN GREEN/YELLOW

Chemicals: This product contains a heating device and the use of substances or chemicals other than those specified may be hazardous. Never use toxic, corrosive, or flammable liquids.

Neutral Live Earth

If the supplied connector is removed, be sure to observe the colour code when reconnecting to an appropriate plug or fused spur.

Read the Chemical Safety Information in Section 1-4 of this manual before use.

For details of fuse replacement refer to Section 3-2: Rear Panel Layout.

Using non-approved chemicals may cause damage to the machine and could void both your warranty and your guarantee of performance.

Important Note: To prevent fire or shock hazard, do not expose the unit to rain or moisture.

Manufacturer Information: Medisafe UK Ltd The Snap Factory Twyford Road Bishop’s Stortford Hertfordshire CM23 3LJ England

Dangerously high voltages are present inside the unit. Do not open the cabinet. Refer servicing and repair to qualified personnel only. Installation and Maintenance: Observe the Routine Checks (Section 3-4), Installation Instructions (Section 2-4) and the Servicing Requirements (Section 4-4) outlined within this manual.

Telephone: Fax: E-mail: Web:

Heat: The temperature within the unit can reach 60oC. during and after operation. Take care when removing items on completion of a cycle and allow good time for the items to cool to a safe temperature before handling.

Ref: UM SI-SA 6 03/11 Rev.J

6

+44 (0) 1279 461641 +44 (0) 1279 461643 [email protected] www.medisafeinternational.com

Section 1-3 - Important Information

User Manual

IMPORTANT! Extended Periods of Inactivity: If the unit is to be left unused for periods in excess of one month, then the following precautions must be observed to prevent the CPE pumps and the various control valves from sticking. 1.

Enter unit into Test Mode by pressing and

13.

holding the ‘STANDBY’ key until the LCD

After 5 seconds, press ‘STAND-BY’ key to close drain.

display indicates ‘TEST MODE’ and then

2.

release.

14.

Repeat steps 12 & 13 at least 4 times.

Momentarily press the ‘+’ or ‘-’ keys to

15.

Press and hold the ‘+’ or ‘-’ keys until the

scroll through menu and check that the

LCD display indicates ‘COLD IN’

LCD display indicates ‘HOT IN’. 16. 3.

Momentarily press the ‘START’ key and

Momentarily press ‘START’ key to activate cold valve.

observe the rising water level in the wash tank.

17.

After 5 seconds, press ‘STAND-BY’ key to turn off cold valve.

4.

When the tank is approximately ¼ full, press the ‘STANDBY’ key to stop water

18.

Repeat steps 16 & 17 at least 4 times.

19.

Press and hold the ‘+’ or ‘-’ keys until the

from entering tank. 5.

Connect one end of the hose intended to

LCD display indicates ‘DRAIN’.

supply 3E-Zyme into the connector

Continue holding until wash tank is empty.

®

marked ‘3E-ZYME®’. 6.

20.

Turn unit off from rear panel.

21.

After 5 seconds, turn unit back on.

Place other end of hose into detergent bottle below fluid level and secure in position.

7.

Press and hold the ‘+’ or ‘-’ keys until the

Failure to observe this procedure could result

LCD display indicates ‘W-CHEM’

in valves remaining open in use which could, in turn, lead to operational errors and possibly

8.

Press and hold the ‘START’

flooding.

key to turn activate wash chemical pump. The 9.

above

procedure

should

also

be

After 10 seconds, press the ‘STANDBY’ key

observed when the unit is likely to be exposed

to deactivate pump.

to ambient temperatures close to, or below, freezing point.

10.

Repeat steps 8 & 9 at least 4 times. Breakdowns which are attributed to the above

11.

12.

Press and hold the ‘+’ or ‘-’ keys until the

procedure being ignored will NOT be covered

LCD display indicates ‘DRAIN’

under the standard warranty (Section 4-5).

Momentarily press ‘START’ key to open drain.

Ref: UM SI-SA 7 03/11 Rev.J

7

Section 1-4 - Important Safety Information

User Manual

Warnings and Cautions: IMPORTANT ANNOUNCEMENT PLEASE READ PRIOR TO ANY CHEMICAL HANDLING

• • • • • • •

An emergency guideline wall chart of the chemical used in machine must be displayed near the machine. Do not use or handle any chemical until you have read and understood the label and the Material Safety Data Sheet (MSDS) for that chemical. In case of any body contact with chemical, always follow emergency procedure given in that particular chemical’s MSDS or call emergency services. Use plastic gloves when handling any chemical. Goggles or full face visor to be worn when working with detergent or chemicals. It is recommended to wear a plastic disposable apron. Use funnel whenever transferring any chemical from one container to another.

Ref: UM SI-SA 8 03/11 Rev.J

8

Section 1-5 - Introduction

User Manual

Service Contracts and Extended Warranty Packages:

Intended Purpose and Performance The Medisafe SI-SA Sonic Irrigator is principally intended to clean hollow (cannulated) instruments, surgical instruments, and associated products. This is achieved through a combination of ultrasonic activity and low-frequency pulsed fluid re-circulation (Cannulated Pulse Enhancement) to dislodge and flush away unwanted debris from both the outside and the inside (hollow instruments only) of items placed in the wash tank.

Your Medisafe SI-SA Sonic Irrigator is supplied with a conditional 12 month parts and labour warranty (Section 4-5) which is effective from the date of installation. Medisafe offer a range of Service Contracts and Extended Warranty Packages which provide continued maintenance and breakdown cover once the original warranty has expired (UK, USA & Germany only).

Washing is achieved using a unique, specially formulated and clinically validated decontamination fluid (3E-Zyme®) which is introduced into the cycle during the program.

Validation Option (UK only): Medisafe can also provide a Validation service which addresses the essential requirements of HTM2030. The work will be performed by an authorised Medisafe engineer and will ensure that your SI-SA Sonic Irrigator continues to conform to HTM2030 guidelines.

If a wash cycle fails to achieve any one of the predetermined parameters then the system reports a failed cycle. The unit registers such a failure on the LCD and the printer, this brings it to the attention of the operator, who is then aware that the cycle has been aborted. The Medisafe SI-SA Sonic Irrigator has been designed to perform within strict and carefully controlled tolerances. A stringent quality control programme ensures that every unit is manufactured and tested under controlled conditions to ensure that all units perform identically. Declaration of Conformity: The Medisafe SI-SA Sonic Irrigator is designed and manufactured in the UK by Medisafe UK Ltd. and complies with the essential requirements of the Medical Devices Directive 93/42/EEC (where appropriate).

Ref: UM SI-SA 9 03/11 Rev.J

9

User Manual ®

BUY 12 & Get 4 FREE

Section 2 : Installation Rev.J

Corporate Branding

Medisafe International, Twyford Road, Bishop’s Stortford, Hertfordshire CM23 3LJ, U.K. T: +44 (0)1279 461641 F: +44 (0)1279 461643 www.medisafeinternational.com E:[email protected]

Ref: UM SI-SA 10 03/11 Rev.J

10

Section 2-1 - Unpacking

User Manual

Unpacking Replacement Parts and Consumables Carefully unpack your Medisafe SI-SA Ultrasonic Irrigator and retain the carton and all packaging materials. If the unit needs to be returned to the supplier for any reason then the original carton and packaging materials should be re-used **.

A range of replacement parts and consumable items approved by Medisafe for use with the SI-SA Ultrasonic Irrigator may be purchased from your supplier. The use of these compatible Medisafe approved products will ensure the continued and reliable operation of your washer.

The unit is supplied with a range of accessories to enable easy installation and efficient operation. Ensure that all these items are present before attempting to install or operate the unit. Complete the following Enclosures Check List and notify your supplier of any shortages or damaged components as soon as possible.

Additional detergent (3E-Zyme®) fluid and thermal printer paper may be purchased from your supplier using the following order codes: 3E-Zyme® Detergent (1 x 4 litre bottle) Part# MED8035 Thermal Printer Paper (1 x 100m roll) Part# MED1014.1

Enclosures Check List • • • • • • • • •

1 Grey drain hose 1 Blue cold water hose 1 Stainless hot water hose 1 Instrument organiser 1 Chemical intake tube 1 SISA basket 1 User Manual 1 Data Lead 1 Overflow Hose with jubilee clip

Disposable Filters (pack 24) Part# MED3079

Using non-approved chemicals, accessories, and replacement parts may cause damage to the machine and could void both your warranty and your guarantee of performance.

1 Plumbing kit comprising: • • • • • •

12 short hose and leur assys 6 ‘Y’ connectors 1 hose adaptor Metal Filter (Drain) Disposable 24 filters 12 Nozzles

** Before transporting a used Medisafe SI-SA it is vital that all fluids are thoroughly drained. If the unit is being returned to your supplier or Medisafe UK Ltd. then the Decontamination Certificate MUST be completed and returned with the unit. The Certificate can be found in Section 4-6 of this manual.

OPTIONS • • •

Thermal printer Printer power supply Medilogger

Ref: UM SI-SA 11 03/11 Rev.J

11

Section 2-2 - Installation Requirements

User Manual

Installation ■■ The product must be unpacked and sited on a stable and level worktop capable of supporting a maximum weight of 51kgs and should be installed 50mm away from sides and minimum of 75mm from back walls for ventilation purposes (see diagram on page 2 for dimensions and installation clearances) ■■ There should be enough free space provided near the machine for safe and efficient maintenance in future. Electrical Supply SISA

SISA Model: MED11150, MED11151, MED11152

Model: MED11160, MED11161, MED11163, MED11164

MED11162,

Voltage & Frequency:

230V nominal (+/- 10%) @ 50Hz Voltage & Frequency:

120V nominal (+/- 10%) @ 60Hz

Outlets:

2 outlets with total capacity of 13A

Outlets:

2 outlets with total capacity of 13A

Position of outlets:

Within 1 meter of proposed installation

Position of outlets:

Within 1 meter of proposed installation

Method of disconnect: Remove mains plugs

Method of disconnect: Remove mains plugs Water Supply

3

Hardness (CaCO ):

<150ppm

Pressure:

1 - 2 Bar

Temperature: Connections: Position of connection:

55 – 75OC (Hot) 15 – 25OC (Cold) 1 x shut off valve with ¾” BSP male thread (Hot) 1 x shut off valve with ¾” BSP male thread (Cold) Within 1 meter of proposed installation Drainage System

SISA Drain:

1 x 1½” dia. drain fitted with suitable traps

Position:

Below the level of work surface

Drainage Capacity: SISA Overflow: Overflow Connection:

> 20 l/minute (Drain hose is supplied with the machine) 1 x 1½” dia. drain fitted with suitable traps 50mm ID to main drain (60mm OD hose supplied with the machine) Printer shelf

Dimensions: Position:

230mm(W) x 280mm (D) Above or to right of the machine and within 1000mm from the machine Chemical Shelf

Dimensions

Suitable provision for detergent for 360mm (wide) x 280mm (deep)

Position:

At machine level

Ref: UM SI-SA 12 03/11 Rev.J

12

Section 2-3 - Dimensions and Clearances

420mm 400mm

Free Area for Lid

User Manual

Sonic Irrigator SA

720mm 50mm Clearance

780mm

50mm Clearance

570mm 75mm Clearance

Ref: UM SI-SA 13 03/11 Rev.J

50mm Clearance

13

Section 2-4 - Installation

User Manual

Connecting the Medisafe SI-SA Ultrasonic Irrigator: Note: Medisafe (UK) Ltd. recommend that this product be installed & commissioned by Medisafe (UK) Ltd. (or a suitably qualified person) before use

1. Unpack the machine and place it on a sturdy, level surface. The unit should be positioned within 1.83m of two 13A mains supply, a suitable drain, and suitable hot and cold mains water supplies.

5. Identify the stainless steel HOT WATER HOSE supplied with the unit. One end of the hose should be screwed onto the hot water inlet at the lower rear of the unit. Ensure the washer fitted to the hose end is in place before tightening. Connect the other end of the hose to a suitable hot water supply.

2. Remove any protective packaging and loose items from inside the wash tank. 3. Identify the grey plastic, convoluted DRAIN HOSE supplied with the unit. The small end of the hose should be connected to the drain outlet at the lower rear of the unit using the adaptor supplied. The large end should be connected to a suitable drain which is below the level of the drain outlet on the unit.

6. Turn on the water supplies and check for leaks. 7. Plug the 3 pin mains plug into a suitable switched outlet.

4. Identify the blue COLD WATER HOSE supplied with the unit. The threaded elbow connector should be screwed onto the cold water inlet at the lower rear of the unit. Ensure the washer fitted to the hose end is in place before tightening. Connect the straight end of the hose to a suitable cold water supply. Overflow hose connection

SISA

Main Fuses

Power Cord

Chemical inlet port

Drain Hot & Cold water Data port supply connections for printer

Ref: UM SI-SA 14 03/11 Rev.J

14

Section 2-4 - Installation

User Manual

Installing the printer

1.

Identify the RS232 DATA LEAD supplied with the unit. Connect the 9-way ‘D’ type connector to the data port to the lower rear of the unit

2.

Connect the other end of the RS232 DATA LEAD to the connector on the rear of the thermal printer

3.

Identify the plug-top POWER SUPPLY with the printer between to the printer and a suitable 13A mains supply outlet

4.

Switch on printer.

RS232 DATA LEAD

POWER

RS232 DATA LEAD

POWER SUPPLY

Your Medisafe SI-SA Ultrasonic Irrigator and Thermal Printer are now ready for use.

Ref: UM SI-SA 15 03/11 Rev.J

15

Section 2-4 - Hyper terminal set-up

1.

User Manual

5.

Locate the Hyper Terminal program in (ProgramsAccessoriesCommunications HyperTerminal) and click ‘Hyper Terminal’.

From the File menu, select Properties >> Settings >> Terminal Keys: Ctrl+H is selected Emulation is set to “Auto Detect” Terminal ID is set to ANSI Buffer is set to 500 Tick “append line feeds to receiving ends” Tick “wrap lines that exceed terminal width” Click ‘OK’ to accept port initialisation

2.

6. From the Transfer menu, select ‘Capture Text’. The incoming data needs to be stored in a file so enter the name of a directory and filename, e.g., “C:XXXHyperDataLog.txt” or browse around and find a suitable folder before adding the name of the file you want to save the data in. Click ‘Start. 7. The XXXHyper Hyper Terminal is now ready and, if linked to a washer, will be receiving data.

Enter name, e.g. “XXXHyper”, and select an icon from those provided. Click ‘OK’.

Washer

ID : 1H15526

Cycle

No: 00083

Cycle start P1

3.

By default, COM1 is selected as the communications port. Click ‘OK’.

17-08-05

Draining

14:06:35

Draining

14:06:43

_

10.

4.

The name of the Hyper Terminal bar has changed to “XXXHyper – Hyper Terminal” and you now have your own Hyper Terminal.

Ref: UM SI-SA 16 03/11 Rev.J

14:06:35

16

When the XXXHyper is closed, all received data will be saved in the DataLog file. Next time you use the Hyper Terminal, use the File menu and select ‘Open’. When you choose to open your Hyper Terminal (i.e., click “XXXHyper”), go to the Capture Text menu and either enter a new file name for the data or retain the existing one, in which case new data will be appended to it. When you have made your choice, click ‘Start’ to begin receiving data when the washer is connected.

User Manual ®

BUY 12 & Get 4 FREE

Section 3 : Operation Rev.J

Corporate Branding

Medisafe International, Twyford Road, Bishop’s Stortford, Hertfordshire CM23 3LJ, U.K. T: +44 (0)1279 461641 F: +44 (0)1279 461643 www.medisafeinternational.com E:[email protected]

Ref: UM SI-SA 17 03/11 Rev.J

17

Section 3-1 - Identifying Controls

User Manual

Front Panel Controls:

Sonic Irrigator SA

LCD DISPLAY Provides visual indication of operational status

INCREMENT Used to increase values in Set-up menu

MODE Used to access program number and time date setup

DECREMENT Used to decrease values in Set-up menu

ENTER Used to enter changes in Set-up menu

STANDBY Used to reset unit after pausing and to exit Set-up menu

START Used to start cycle or continue after pausing

Ref: UM SI-SA 18 03/11 Rev.J

18

Section 3-2 - Rear Panel Layout

User Manual

Rear Panel Layout

SERIAL DATA PORT

FUSES Mains supply fuse (32mm cartridge type) 8AT 230V 12.5AT 110V

RS232 data output to printer or PC

Power Cord

Fuse Replacement: The SI-SA comes fitted with plug and a 13 amp (13A) fuse. If you need to replace the fuse, use only those rated at 13 amp (13A) and ASTA approved to BS1362. To change the fuse follow the steps indicated below, 1. 2. 3. 4. 5.

Ensure that power supply to machine is disconnected. Using a screwdriver, push the centre section inwards whilst turning anti-clockwise. Remove centre section complete with fuse. Substitute damaged fuse with one of identical type and rating as stated above. Replacement is a reversal of the above procedure.

Ref: UM SI-SA 19 03/11 Rev.J

19

Section 3-3 - Operating Instructions

User Manual

3-3-1 Operating a Wash Cycle 1.

Load instruments into basket and place basket into wash tank. Ensure that the basket feet (flush ports) are correctly located over docking ports on base of wash tank. Slide basket side ways to lock in position.

2.

Apply power to the product.

3.

Close lid.

4.

Check that the following message is displayed on the LCD DISPLAY:

Load Instruments P# Press START

Important Information on Loading Instruments The main basket is capable of cleaning up to 12 hollow instruments in one session.

5.

When loading instruments into basket be sure to observe the following precautions:

Observe the messages shown on the LCD DISPLAY and follow this procedure: START

Do not drop items into the empty wash tank as this could damage the ultrasonic transducers.

The wash cycle will now commence and proceed automatically as detailed in ‘Operating Process’ in Section 4-1 of this manual.

Do not place items to be cleaned directly into the wash tank or allow them to make contact with the sides of the tank. Do not load basket with instruments pointing at the lid or the level sensors.

6.

Do not overload basket.

Unload Press START

Always attach tubing to a Distal Connector of suitable size for the instrument being cleaned or to a quick connect port if the instrument has one.

Note: The prevailing wash cycle will be aborted if the lid is opened at any time during the cycle.

Always open box jointed instruments. Always ensure that instruments are open.

taps

on

Always dissemble instruments designed to be taken apart

cannulated

which

are

Always connect instruments of similar bore size to the same manifold. Always attach at least 1 leur pipe to each manifold if cannulated instruments are not being cleaned as this will aid water circulation.

Ref: UM SI-SA 20 03/11 Rev.J

When the cycle is completed, the following message will be displayed. Open lid and remove load.

20

Section 3-3 - Operating Instructions

3-3-2 Program No. 2 & 4 (Re-Wash):

User Manual

8. Machine will start the wash again in the same water.

Program No.2 & 4 is a re-wash program, in which user can run wash cycle by using same water. At end of wash, user is allowed to open lid and add new instruments to run another wash cycle.

Ending the Cycle: When machine shows the following message at the end of every wash in program No.2.

At end of each wash, machine flashes following message

WASH END Press

WASH END Press

And

ENTER to END START to REPEAT

And

ENTER to END START to REPEAT

Follow steps below to finish program 2 or 4.

Unloading instruments and Re –wash: 1. Press ENTER twice to END the cycle. Follow steps below to repeat wash in same water when above message is shown on display,

ENTER

1. Press START once to acknowledge.

2. Machine will drain all water and will show following message when instruments are ready to unload.

START

Unload Press START

2. Machine will show the following message.

3. Press START once.

Unload Press START

START

3. Open lid carefully and unload the clean instruments. 4. Add more instruments for cleaning 5. Close the lid 6. Press START, machine will show the following message.

4. Open lid carefully and unload the clean instruments 5. After finishing unloading of instruments, press START again. Machine will show the following message to run another cycle.

Press START to REPEAT

Load Instruments P# Press START

7. Press START again, START

Ref: UM SI-SA 21 03/11 Rev.J

21