BUY 12 & Get 4 FREE 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:info@medisafeinternational.com Ref: UM SI-SA 1 03/11 Rev.J 1
Table of Contents Section Title Page 1 Introduction 3 1-1 Memorandum of Registration 4 1-2 Trained Personnel 5 1-3 Important Information 6 1-4 Important Safety Information 8 1-5 Introduction 9 2 Installation 10 2-1 Unpacking 11 2-2 Installation Requirements 12 2-3 Dimensions and Clearances 13 2-4 Installation 14 2-5 Hyper Terminal Setup 16 3 Operation 17 3-1 Identify Controls 18 3-2 Rear Panel Control 19 3-3 Operating Instructions 20 3-3-1 Operating a Wash Cycle 20 3-3-2 Program No. 2 & 4 (Rewash) 21 3-3-3 Changing Programme 22 3-3-4 Aborting a Wash Cycle 22 3-3-5 Changing Programme Parameters 22 3-4 Routine Checks 24 4 Technical 26 4-1 Operating Process 27 4-2 Technical Specification 29 4-3 Troubleshooting 31 4-4 Service Record 33 4-5 Warranty 34 4-6 Decontamination Certificate 35 4-7 Decontamination Guide 36 Ref: UM SI-SA 2 03/11 Rev.J 2
Section 1 : Introduction BUY 12 & Get 4 FREE 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:info@medisafeinternational.com Ref: UM SI-SA 3 03/11 Rev.J 3
Section 1-1 - Memorandum of Registration 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 : 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 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 Name Signature Ref: UM SI-SA 5 03/11 Rev.J 5
Section 1-3 - Important Information Product Identity 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. Electrical The power cord and connector supplied with this machine are wired according to the following colour code: BLUE BROWN GREEN/YELLOW 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. For details of fuse replacement refer to Section 3-2: Rear Panel Layout. Important Note: To prevent fire or shock hazard, do not expose the unit to rain or moisture. 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. Heat: The temperature within the unit can reach 60 o C. 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. 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. 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). 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. Read the Chemical Safety Information in Section 1-4 of this manual before use. Using non-approved chemicals may cause damage to the machine and could void both your warranty and your guarantee of performance. Manufacturer Information: Medisafe UK Ltd The Snap Factory Twyford Road Bishop s Stortford Hertfordshire CM23 3LJ England Telephone: +44 (0) 1279 461641 Fax: +44 (0) 1279 461643 E-mail: info@medisafeinternational.com Web: www.medisafeinternational.com Ref: UM SI-SA 6 03/11 Rev.J 6
Section 1-3 - Important Information 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 holding the STANDBY key until the LCD display indicates TEST MODE and then release. 13. After 5 seconds, press STAND-BY key to close drain. 14. Repeat steps 12 & 13 at least 4 times. 2. Momentarily press the + or - keys to scroll through menu and check that the LCD display indicates HOT IN. 3. Momentarily press the START key and observe the rising water level in the wash tank. 4. When the tank is approximately ¼ full, press the STANDBY key to stop water from entering tank. 5. Connect one end of the hose intended to supply 3E-Zyme into the connector marked 3E-ZYME. 6. Place other end of hose into detergent bottle below fluid level and secure in position. 15. Press and hold the + or - keys until the LCD display indicates COLD IN 16. Momentarily press START key to activate cold valve. 17. After 5 seconds, press STAND-BY key to turn off cold valve. 18. Repeat steps 16 & 17 at least 4 times. 19. Press and hold the + or - keys until the LCD display indicates DRAIN. Continue holding until wash tank is empty. 20. Turn unit off from rear panel. 21. After 5 seconds, turn unit back on. 7. Press and hold the + or - keys until the LCD display indicates W-CHEM 8. Press and hold the START key to turn activate wash chemical pump. 9. After 10 seconds, press the STANDBY key to deactivate pump. 10. Repeat steps 8 & 9 at least 4 times. 11. Press and hold the + or - keys until the LCD display indicates DRAIN Failure to observe this procedure could result in valves remaining open in use which could, in turn, lead to operational errors and possibly flooding. The above procedure should also be observed when the unit is likely to be exposed to ambient temperatures close to, or below, freezing point. Breakdowns which are attributed to the above procedure being ignored will NOT be covered under the standard warranty (Section 4-5). 12. Momentarily press START key to open drain. Ref: UM SI-SA 7 03/11 Rev.J 7
Section 1-4 - Important Safety Information 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 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. Washing is achieved using a unique, specially formulated and clinically validated decontamination fluid (3E-Zyme ) which is introduced into the cycle during the program. 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. Service Contracts and Extended Warranty Packages: 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). 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. 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
Section 2 : Installation BUY 12 & Get 4 FREE 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:info@medisafeinternational.com Ref: UM SI-SA 10 03/11 Rev.J 10
Section 2-1 - Unpacking Unpacking 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 **. 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. 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 1 Data Lead 1 Overflow Hose with jubilee clip Replacement Parts and Consumables 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. 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 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 OPTIONS Thermal printer Printer power supply Medilogger ** 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. Ref: UM SI-SA 11 03/11 Rev.J 11
Section 2-2 - Installation Requirements 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. Hardness (CaCO 3 ): Pressure: Temperature: Connections: Position of connection: SISA Drain: Position: Drainage Capacity: SISA Overflow: <150ppm 1-2 Bar 55 75 O C (Hot) 15 25 O C (Cold) Electrical Supply SISA Model: MED11150, MED11151, MED11152 SISA Model: MED11160, MED11161, MED11162, MED11163, MED11164 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: Water Supply 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 1 x 1½ dia. drain fitted with suitable traps Below the level of work surface > 20 l/minute (Drain hose is supplied with the machine) 1 x 1½ dia. drain fitted with suitable traps Within 1 meter of proposed installation Method of disconnect: Remove mains plugs Method of disconnect: Remove mains plugs Overflow Connection: 50mm ID to main drain (60mm OD hose supplied with the machine) Printer shelf Dimensions: 230mm(W) x 280mm (D) Position: 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 Sonic Irrigator SA Free Area for Lid 400mm 420mm 720mm 50mm Clearance 50mm Clearance 780mm 570mm 75mm Clearance 50mm Clearance Ref: UM SI-SA 13 03/11 Rev.J 13
Section 2-4 - Installation 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. 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. 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. 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 Chemical inlet port Power Cord Hot & Cold water supply connections Drain Data port for printer Ref: UM SI-SA 14 03/11 Rev.J 14
Section 2-4 - Installation 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 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. Locate the Hyper Terminal program in (Programs\Accessories\Communications\ HyperTerminal) and click Hyper Terminal. 5. 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. Enter name, e.g. XXXHyper, and select an icon from those provided. Click OK. 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:\XXXHyper\DataLog.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. Washer ID : 1H15526 Cycle No: 00083 Cycle start P1 14:06:35 17-08-05 Draining 14:06:35 3. By default, COM1 is selected as the communications port. Click OK. Draining 14:06:43 _ 4. The name of the Hyper Terminal bar has changed to XXXHyper Hyper Terminal and you now have your own Hyper Terminal. 10. 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. Ref: UM SI-SA 16 03/11 Rev.J 16
Section 3 : Operation BUY 12 & Get 4 FREE 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:info@medisafeinternational.com Ref: UM SI-SA 17 03/11 Rev.J 17
Section 3-1 - Identifying Controls Front Panel Controls: Sonic Irrigator SA LCD DISPLAY Provides visual indication of operational status INCREMENT Used to increase values in Set-up menu DECREMENT Used to decrease values in Set-up menu MODE Used to access program number and time date setup 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 Rear Panel Layout SERIAL DATA PORT RS232 data output to printer or PC FUSES Mains supply fuse (32mm cartridge type) 8AT 230V 12.5AT 110V 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. Ensure that power supply to machine is disconnected. 2. Using a screwdriver, push the centre section inwards whilst turning anti-clockwise. 3. Remove centre section complete with fuse. 4. Substitute damaged fuse with one of identical type and rating as stated above. 5. Replacement is a reversal of the above procedure. Ref: UM SI-SA 19 03/11 Rev.J 19
Section 3-3 - Operating Instructions 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. Important Information on Loading Instruments The main basket is capable of cleaning up to 12 hollow instruments in one session. When loading instruments into basket be sure to observe the following precautions: Do not drop items into the empty wash tank as this could damage the ultrasonic transducers. 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. Do not overload basket. 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. Always open box jointed instruments. Always ensure that taps on cannulated instruments are open. 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 5. Observe the messages shown on the LCD DISPLAY and follow this procedure: START The wash cycle will now commence and proceed automatically as detailed in Operating Process in Section 4-1 of this manual. 6. When the cycle is completed, the following message will be displayed. Open lid and remove load. Unload Press START Note: The prevailing wash cycle will be aborted if the lid is opened at any time during the cycle. Always dissemble instruments which are designed to be taken apart 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 20
Section 3-3 - Operating Instructions 3-3-2 Program No. 2 & 4 (Re-Wash): 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. At end of each wash, machine flashes following message WASH END Press And ENTER to END START to REPEAT 8. Machine will start the wash again in the same water. Ending the Cycle: When machine shows the following message at the end of every wash in program No.2. WASH END Press And ENTER to END START to REPEAT Follow steps below to finish program 2 or 4. Unloading instruments and Re wash: Follow steps below to repeat wash in same water when above message is shown on display, 1. Press ENTER twice to END the cycle. ENTER 1. Press START once to acknowledge. START 2. Machine will drain all water and will show following message when instruments are ready to unload. 2. Machine will show the following message. Unload Press START Unload Press START 3. Press START once. START 3. 4. 5. 6. Open lid carefully and unload the clean instruments. Add more instruments for cleaning Close the lid Press START, machine will show the following message. 4. 5. Open lid carefully and unload the clean instruments 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
Section 3-3 - Operating Instructions 3-3-3 Changing Programme To select an alternative wash program, or to amend the wash temperature, follow this procedure (see page 23 for parameter ranges). 3-3-4 Aborting a Wash Cycle Press and hold STANDBY button STAND-BY Press and hold MODE button once MODE The parameter to be amended will be displayed on the LCD DISPLAY Wash TIME 10 mins The following message will be displayed on the LCD DISPLAY Paused: RESET or RESTART To abort cycle, press STANDBY button once Press and hold INCREMENT or DECREMENT buttons to amend value STAND-BY + To increase number To decrease number Press ENTER button to store amended value ENTER Press and hold MODE button to select next parameter 3-3-5 Changing Programme Parameters Various parameters relating to the wash cycle may be programmed by the user. Details of these parameters and how to adjust them can be found on pages 23 of this manual. Note: The performance of this product is validated on the factory default settings at the time of installation. MODE Press STAND-BY button to save changes and exit set-up menu STAND-BY Ref: UM SI-SA 22 03/11 Rev.J 22
Section 3-3 - Operating Instructions The following parameters are adjustable within the range indicated below: # Parameter Increment Min Max 1 Wash Time Minutes 5 25 2 Temperature Degrees C. 20 60 3 Set Time (hours) n/a n/a 4 Set Time (minutes) n/a n/a 5 6 Set (day) Set (month) INCREMENT key to increase DECREMENT key to decrease MODE key to select next parameter ENTER key to save changes n/a n/a n/a n/a 7 Set (year) n/a n/a SISA Program Parameters: Parameter Units Programme Number 1 2 3 4 5 6 1 Wash cycle Mins 010 010 010 ** 010 015 2 Rinse Cycle Mins 002 002 002 000 002 002 3 Wash temperature o C 040 040 040 040 040 040 4 Wash chemical dose time Secs 005 005 005 005 005 005 5 Flush Pre-Degas Secs 015 015 015 000 015 015 6 Sonics wash cycle Secs 045 045 045 000 045 045 7 Flushing wash cycle Secs 015 015 015 000 015 015 8 Draining Secs 020 020 020 020 020 020 9 Rinse Temperature o C 040 040 040 000 040 040 10 Sonics rinse cycle Secs 045 045 045 000 045 045 11 Flushing rinse cycle Secs 015 015 015 000 015 015 12 Time off sonics/flushing Secs 015 015 015 000 015 015 13 Pre-wash cycle Mins 003 003 003 000 003 003 14 Degas Mins 005 005 005 005 005 005 15 Pre-rinse cycle Mins 000 000 000 000 002 002 Ref: UM SI-SA 23 03/11 Rev.J 23
Section 3-4 - Routine Checks Routine Checks To ensure that your Medisafe SI-SA Ultrasonic Irrigator continues to operate within its design parameters it is recommended that the following checks are performed on a regular basis. Consulting the troubleshooting guide on page 31 of this manual may prove useful when conducting the checks. Note: The completion of these checks is not a substitute for regular servicing and maintenance by a suitably qualified engineer. Before every cycle Perform the following procedures before each wash cycle: Check Disposable filter in wash tank Check if drain filter is dirty and replace with the new filter if required. Please note that this filter must be replaced after every 10 cycles. Check Metal Filter(drain) in wash tank Clean metal filter on drain if required Wipe ALL water level sensors Using a soft nylon brush or non-greasy alcohol wipes, clean the three plastic water level sensors located in the wash tank to remove all traces of debris, and then dry thoroughly. Daily Checks The following checks should be performed daily Check cleanliness of all external surfaces The outside of the unit (including lid seal) should be cleaned by using a disinfectant wipe or equivalent hospital approved surface disinfactant spray. Check lid and lid seal Inspect the lid seal for any signs of damage. Ensure that lid can be opened and closed without restriction. Check that the wash tank is clean and free from any deposit The wash tank may be cleaned by wiping with a decontaminant wash or suitable disinfectant. Check condition of hoses connecting basket to ports in wash tank Ensure that hoses are not kinked or ruptured. Check condition of basket docking ports Check that the two docking ports located on the bottom of the wash tank are undamaged and free of debris. Disposable Filter Metal Filter (Drain) Check level of detergent (3E-Zyme ) Visually inspect fluid bottles. If low, then replenish as necessary. Docking ports Ref: UM SI-SA 24 03/11 Rev.J 24
Section 3-4 - Routine Checks Weekly Checks The following checks should be performed every week: Check cleaning efficiency of unit. Perform test by using Valisafe Standard PCD kit(process Challenge Device) or equivalent Run a wash cycle (refer to section 3-3) Check that test strip is completely cleaned with no red or clear residue remaining. PCD kit part number: M20230 - PCD starter kit V3502082 - Cleaning Efficacy Indicator Pk of 10 V3502080 - Cleaning Efficacy Indicator Pk of 50 Check water supply hoses to unit. Ensure that hoses connecting the unit to the water supplies are not trapped or kinked. Ensure that hose connectors are not leaking. Check mains power cord. Ensure that the mains power cord is not trapped or damaged. Check that connector to the mains supply is secure. Check accuracy of electronic control systems. The following table indicates the target wash parameters which must be met to ensure efficient operation of the unit. The accuracy of these parameters should be monitored using a recent print-out from the Medisafe Thermal Printer (or by viewing the information directly from the Front Panel LCD as the cycle progresses) to compare the data with the target parameters listed below. Initial Drain duration 20s (min) Pre-Wash duration 3m Dispensing Chemical duration* 5-7s De-gas duration 5m Main Wash duration* 5-25m Main Wash temperature* (Default 43 o C) 20-60 o C Rinse duration 2m Repeat Wash duration* 5-25 mins Repeat Wash temperature* 20-60 o C Repeat Rinse duration 2m Total cycle time (approx.) *30-35m * Dependent upon user programming Weekly machine decontamination routine: Please see Note on page 36 Quarterly Checks The following checks should be performed Quarterly week The ultrasonic activity Test (Foil Test) Check ultrasonic activity by using Test Foil. (Please refer to service manual for correct Foil Test procedure) Note The ultrasonic activity test should be conducted by a qualified test person as it requires access to engineering mode. Ref: UM SI-SA 25 03/11 Rev.J 25
Section 4 : Technical BUY 12 & Get 4 FREE 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:info@medisafeinternational.com Ref: UM SI-SA 26 03/11 Rev.J 26
Section 4-1 - Operating Process GENERAL CYCLE PROCESS This is a general cycle process for Medisafe SI SA. Program 1, 3, 5 & 6 are programmed to the following cycle process depending on pre set parameters. However program 2 & 4 are introduced as rewash programs and act as sonic bath. More details about these rewash programs given later in this section. When the START button is depressed, the Medisafe SI-SA Ultrasonic Irrigator operates in the following way: DRAIN The drain pump is activated for a period of 20 seconds to ensure that all fluid has been removed from wash chamber and tubing. PRE-WASH Cold water enters the unit through the cold water valve until the wash tank if full, as detected by the top level sensor. The PRE-WASH is then activated for a fixed period of 3 minutes. During this time the CPE pumps are turned on for 15 seconds in every minute, filtered water taken from the bottom of the wash tank is then circulated through the instruments. After 3 minutes the wash tank is drained until emptied, as detected by the bottom water level sensor. FILL FOR MAIN WASH The hot and cold valves are turned on and off, according to the temperature reported by the temperature sensors mounted below the wash tank, to admit water into the wash tank to enable a correct temperature of 43 O C. The CPE pumps are then switched on for a short time to circulate the water to assist in achieving a uniform temperature. The alternating hot/cold fill continues until 5 seconds after the top level sensor detects water. CHEMICAL DOSE A wash chemical is pumped into the wash tank for a fixed (programmable) period, commencing part way through the wash fill cycle. DE-GAS A fixed period of 5 minutes is allowed to enable excess air and gas to be removed from the water in the tank before the cycle continues. MAIN WASH The MAIN WASH period of 10 minutes. During this time the CPE pumps are turned on for 15 seconds in every minute. During flushing, filtered water taken from the bottom of the wash tank is then circulated through the instruments by the pump. The drain pump is then activated to empty the tank and continues until the bottom level sensor detects that all fluid has been removed from wash chamber. FINAL RINSE Cold water enters the unit through the cold water valve until the wash tank is full, as detected by the top level sensor. The RINSE is then activated for a fixed period of 2 minutes. During this time the CPE pumps are turned on for 15 seconds in every minute ultrasonics on/ CPE flushing on. During flushing, filtered water taken from the bottom of the wash tank is then circulated through the instruments by the CPE pump. The drain pump is then activated to empty the tank and continues until the bottom level sensor detects that all fluid has been removed from wash chamber. Ref: UM SI-SA 27 03/11 Rev.J 27
Section 4-1 - Operating Process PROGRAM 2 & 4 Program 2 & 4 are rewash programs. These two programs proceeds in the same way as Program 1 until the end of the MAIN WASH stage. Then you are given the option to rewash using the water in the tank or proceed to finish the cycle with the final rinse stage. The difference between program 2 & 4 is that, the program 2 is ultrasonic wash with instrument irrigation facility and program 4 provides only ultrasoinc wash. Process Monitoring Throughout the entire cycle, various factors are monitored and, if necessary, acted upon by the microprocessor. These factors are as follows: OVERFLOW If the water level in the unit reaches the level of the overflow sensor then an error message is displayed. The cycle must then be reset by opening the lid or by pressing and holding the Stand-By key. The drain pump is then activated and the wash tank is drained until empty. LOW TEMPERATURE If the temperature recorded at the start of the WASH stage is greater than 4 O C. below the pre-set temperature then the unit will display an error message. The unit must then be reset as described for OVERFLOW. POWER FAILURE If the power fails during a cycle then an error message is displayed. The unit must then be reset using the method described for OVERFLOW. DATA OUTPUT All parameters reported by the unit during each cycle are output as a serial data stream (RS232) for logging either on a printer, or as text files on a PC equipped with suitable software. Ref: UM SI-SA 28 03/11 Rev.J 28
Section 4-2 - Technical Specification General: Description: Sonic Irrigator (Benchtop Models) MED11150 240V 50Hz MED11152 240V 60Hz MED11160 110V 60Hz Intended Purpose: Operating Process: Applied Standards: BS2745: part 1: 1993 BS2745: part 3: 1993 EN60101-1:2001 (2nd Edition) EN61010-2-045 (2001) EN61326: 1997 A1: 1998 EN980 Wash Cycle Parameters: Min. Temp. During Cycle: Max. Temp. During Cycle: Medical Device Class I Internal and external cleaning of surgical instruments, hollow-ware, and associated products Ultrasonic activity determined by temperature of water supply ** See Note (Ultrasonic activity also has a heating effect of one to three degrees C per 15 minutes) Vol. of Dispensed Chemicals: 3E-Zyme detergent: 160ml (approx) Required Services: Electricity Supply: Supply Voltage: single phase 230V or 110V (nominal) AC 50Hz Power Consumption: 0.8KVA max. Termination: 3 pin type earthed plug (fused @ 13A if UK) Lead Length: 1.83m (6 feet) Water Supply: Supply Connection (hot): ¾ BSP Male Union Supply Connection (cold): ¾ BSP Male Union Optimum pressure: 1.5 BAR (22psi) Acceptable Pressure Range: 1.5-2.5 bar (21-35psi) hot & cold water Effect of Lower Pressure: increased filling time leading to extended total cycle time Acceptable Flow Rate: not less than 2 litres/min Effect of Reduced Flow: increased filling time leading to extended total cycle time Volume Used per Cycle: Hot:approx 15 litres Cold:approx 50 litres Acceptable Temp. Range: Hot: 55-75 o C (with cold tank) * Cold: 5 25 * Hardness: not more than 150 ppm Note: * Temperature sensors do not read below 15 o C ** Water temperature at start of cycle should be 15 o C above the temperature programmed for the wash cycle (wash temp 40 o C. Hot water in: 55 o C). Ref: UM SI-SA 29 03/11 Rev.J 29
Section 4-2 - Technical Specification Drain: Discharge Orifice Type: 18mm outside dia. unthreaded hose tail ** Drain position: ** Drain entry should be below level of discharge orifice with no part of the drain hose above the orifice (i.e. no loops in the hose) Installed Requirements: See page 12 Important Note: Dangerously high voltages are present inside the unit. Do not open the cabinet. Refer servicing and repair to qualified personnel only Max. Flow to Drain: Max. Temp. of Effluent: 15 litres/min 50 o C Ventilation: Max. Heat Output of Load: 50 o C Chemicals: Size and Nature of Containers: 3E-Zyme Fluid: 4 litre plastic bottle Storage Instructions: 3E-Zyme Fluid: Refer to Data sheet provide with chemical. Safe Handling Instructions: 3E-Zyme Fluid: Refer to Data Sheet provided with chemical. Weight: Operational weight (dry): Shipping weight: 51kg 30kg Dimensions: Wash Chamber Volume: 28,275 cm 3 Outer Cabinet Dimensions: 720mm (W) 400mm (H) 570mm (D) Carton Dimensions: 850mm (W) 520mm (H) 720mm (D) Ref: UM SI-SA 30 03/11 Rev.J 30
Section 4-3 - Troubleshooting Troubleshooting Use this guide to overcome any operational errors which may be encountered whilst using your Medisafe SI-SA Ultrasonic Irrigator. If the problem remains unresolved after consulting this guide then contact your supplier. Message displayed Lid open Power failure Possible cause(s) Check lid is closed properly by applying light downward pressure on lid Check mains power supply to unit was not interrupted during cycle Check mains plug is correctly inserted and power cord is not over stretched Wipe WL Sensors Check that sensor faces in main wash chamber are free from moisture Clean and dry sensors (use alcohol swab) Reposition instruments to prevent water being directed at sensors Overflowing Emptying Error There may be a fault with the washer, repeat cycle, if it fails again call engineer Check baskets and instruments are clear of sensors and drain hole Check unit is installed on level surface Check that genuine Medisafe 3E-Zyme (non-foam) wash chemical is being used Check that the drain hose is not blocked or kinked Check that the filter is not blocked Temperature Error This is a system check and if displayed indicates that one or both the temperature sensors may be faulty. Reset and repeat the cycle and if it still fails, call engineer Water Temp Low Check that temperature of incoming hot water is adequate. (55 o C) the first cycle of the day could fail if the hot water supply is not close to the machine Cold Water Error Water Level Low Check cold water supply is turned on Check drain valve is not being held open by debris (seek advice and turn off unit) Ref: UM SI-SA 31 03/11 Rev.J 31
Section 4-3 - Troubleshooting Message displayed Wash Fill Error Rinse Fill Error Possible cause(s) This means that the hot or cold supply is not reaching the washer Check strainer in inlet valve (where water supply connects to unit) is not blocked Beware: possible risk from hot water Problem Water leaking from lid area Possible cause(s) Check instruments are laying flat in basket and not pointing up at lid Check lid seal is undamaged Unit takes excessive time to fill Check incoming cold water pressure is between 1.5 bar and 2.5 bar Check strainer in inlet valve (where water supply connects to unit) is not blocked Beware: possible risk from hot water Irrigation ports inoperative and/or low water flow rate Check drain filter in bottom of wash tank is not blocked Check connection port in wash tank is not blocked Check connectors are pushed fully home Unit not cleaning properly Check chemical dose is correct Check for overloading of instruments in basket Check instruments are not excessively soiled Check that genuine Medisafe 3E-Zyme (non-foam) wash chemical is used Check that no more than 2 hours has elapsed since instruments were used Ref: UM SI-SA 32 03/11 Rev.J 32
Section 4-4 - Service Record Medisafe recommend that your SI-SA Ultrasonic Irrigator is serviced in accordance with the schedule contained within the SI-SA Service Manual at intervals of 3 months. This record should be completed by the Engineer conducting the Service and should be made available in the event of a warranty claim or breakdown repair. Note: No user serviceable parts inside. Service and repair should be referred to qualified persons only. Serviced by/ 3 Month Serviced by/ 6 Month Serviced by/ 9 Month Cycles since last service Cycles since last service Cycles since last service Next service due Cycles Next service due Cycles Next service due Cycles 12 Month Serviced by/ 15 Month Serviced by/ 18 Month Serviced by/ Cycles since last service Cycles since last service Cycles since last service Next service due Cycles Next service due Cycles Next service due Cycles 21 Month Serviced by/ 24 Month Serviced by/ 27 Month Serviced by/ Cycles since last service Cycles since last service Cycles since last service Next service due Cycles Next service due Cycles Next service due Cycles 30 Month Serviced by/ 33 Month Serviced by/ 36 Month Serviced by/ Cycles since last service Cycles since last service Cycles since last service Next service due Cycles Next service due Cycles Next service due Cycles Ref: UM SI-SA 33 03/11 Rev.J 33
Section 4-5 - Warranty PRODUCT WARRANTY To ensure continued efficiency and long operational life, your new Sonic Irrigator is covered by a one year warranty/5,000 cycle warranty which is arranged and administered by Medisafe (UK) Ltd. Details of the warranty are explained in this section. Fair wear and tear of any part, normal maintenance service items, and the parts and any material used in connection with the new Sonic Irrigator. Normal deterioration or damage to plated parts, paint coat, and rubber parts caused by daily wear and exposure to atmosphere and environment. Subject to the following terms and conditions, Medisafe (UK) Ltd. warrants that any item of THE BASIC WARRANTY ITEMS of the unit (hereinafter called new Sonic Irrigator ) manufactured by Medisafe (UK) Ltd. shall be free from any defects in material and workmanship under normal use and maintenance. Any item of THE BASIC WARRANTY ITEMS covered by the limited warranty will be repaired or replaced free of charge by Medisafe (UK) Ltd. or any distributor authorised by Medisafe (UK) Ltd. to act as their agent (hereinafter called authorised Medisafe dealer or distributor ). THE BASIC WARRANTY ITEMS Minor irregularities not affecting quality, performance or function of the new Sonic Irrigator parts thereof (e.g. slight noise or vibration) or which appear only under particular abnormal conditions. Damage caused by insufficient or improper maintenance (e.g. negligence of the daily, weekly, and monthly periodic inspections and any servicing requirements as described and specified within this manual). Damage caused by using a part or lubricants not approved by an authorised Medisafe dealer or distributor or being repaired or replaced by a person who is not an authorised Medisafe dealer or distributor. THE BASIC WARRANTY ITEMS are any items (except THE SPECIFIC EXCLUDED ITEMS) of this new Sonic Irrigator which are warranted by an authorised Medisafe dealer or distributor within 12 months or 5,000 cycles (whichever occurs first) of the WARRANTY START DATE when this new Sonic Irrigator is first installed by or for you (the original purchaser) as set forth on the Memorandum of Registration (Section 1-1, p.4). THE BASIC WARRANTY ITEMS listed below are warranted within 12 months or 5,000 cycles (whichever occurs first) from the WARRANTY START DATE against defects in manufacture. - solenoid valves - electric motors and pumps - switches - electronic control circuits - water heating elements - ultrasonic transducers THE SPECIFIC EXCLUDED ITEMS Damage caused by accident, abuse, or negligence of the proper handling as set out in this Owner s Manual, misuse of the new Sonic Irrigator, use of the new Sonic Irrigator under unusual conditions, and modifications of or to the new Sonic Irrigator or any component/parts thereof not recommended or approved by an authorised Medisafe dealer or distributor. Damage caused by external influences such as chemical spillage, accident, fire, and disasters due to human fault or negligence or Act of God. Damage to the external casing, wash chamber, load carriers, or any part of the new Sonic Irrigator which may come into contact with the load carrier during the process of loading/unloading the new Sonic Irrigator. All charges incidental to breakdowns, such as loss of use of the new Sonic Irrigator, loss of time, inconvenience, telephone, transportation, loss or damage to personal property or loss of revenues, or other matter not specifically included. THE SPECIFIC EXCLUDED ITEMS are any items of this new Sonic Irrigator which are not included in THE BASIC WARRANTY ITEMS and are therefore not subject to the terms and conditions of the PRODUCT WARRANTY. Damage caused by incorrect installation of the new Sonic Irrigator which could cause operational failure or impairment either immediately after such installation or at any time within the period of this PRODUCT WARRANTY. Expendable items which will deteriorate and require replacement with normal use of the Washer (for example: lid seal, water inlet filter element, various types of gaskets and hoses, lamp bulbs (if fitted), and other expendable parts not specifically listed) Medisafe (UK) Ltd. reserves the right of final decision on all manufacturers warranty claims. Nothing herein affects the statutory rights of a consumer. Ref: UM SI-SA 34 03/11 Rev.J 34
Section 4-6 - Decontamination Certificate DECONTAMINATION CERTIFICATE ENSURE THAT ITEMS RETURNED TO YOUR SUPPLIER ARE DISINFECTED IN ACCORDANCE WITH THE APPROPRIATE HOSPITAL PROCEDURE FOR EQUIPMENT OF THIS TYPE THIS FORM MUST BE COMPLETED AND ATTACHED TO THE OUTSIDE OF THE CARTON WHEN RETURNING THE PRODUCT TO YOUR SUPPLIER. WITHOUT THIS FORM BEING VISIBLE THE COURIER AND/OR YOUR SUPPLIER ARE AT LIBERTY TO REFUSE HANDLING OF THE PRODUCT. I hereby certify that the machine referred to in this document by model number and serial number has been disinfected in accordance with Hospital Procedure Model No: SI-SA Ultrasonic Irrigator Serial No: Hospital: Name: Signature: : Promoting a Clean and Safe Service Ref: UM SI-SA 35 03/11 Rev.J 35
Section 4-7 - Decontamination Guide All medical washers should be cleaned weekly as part of the routine maintenance for operator s Health and Safety, for the purposes of routine maintenance (PRIOR to the arrival of the engineer) and for transportation. By decontamination, we refer to the unit being cleaned and disinfected. Machines returned in an un-cleaned state WILL incur additional charges for cleaning and decontamination. For the internal or external surfaces a disinfectant cleaner (e.g. Medisafe DISS-ALL - product code MED8051), or any household kitchen cleaner can be used providing it is marked as a DISINFECTANT CLEANER. Important safety information: All safety precautions recommended for the cleaning product used must be adhered to. In all cases, the wearing of PPE, including gloves and eye-shields are strongly recommended. Cleaning/decontamination instructions. general Apply the chosen chemical onto a clean cloth or paper towel and wipe over the surfaces as mentioned below. Rinse off with tap water on a cloth or paper towel and dry. For machines with a tank assembly, the tank must be filled with clean water containing a 5% solution of household bleach (Sodium Hypochlorite) and then rinsed with clean water. The internal area that is not immersed including the underside of the lid must also be disinfected. All units must be drained down thoroughly prior to return. Note: By the nature of its operation, this machine can not run disinfection cycle so select prog- 3. Add water and disinfectant cleaner manually. Run full cycle with all irrigation ports open ( This will be achieved by the connection of hose and lures to the irrigation ports)and at the end drain all water manually. All that is required then is to clean and disinfect the outside surfaces, and around the sides of the door and door seals/hinges, as the normal wash process will not clean them. If, however, due to the nature of any fault present, the unit cannot be run prior to return, the tank/chamber must be cleaned and decontaminated by hand following the process outlined in the notes above. 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:info@medisafeinternational.com Ref: UM SI-SA 36 03/11 Rev.J 36