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Compliance with the Control of Noise at Work Regulations 

The Control of Noise at Work Regulations 2005 (the Noise Regulations 

[1]

) came into force for all 

industry sectors in Great Britain on 6 April 2006. 
 
The aim of the Noise Regulations is to ensure that workers’ hearing is protected from excessive 
noise at their place of work, which could cause them to lose their hearing and /or to suffer from 
tinnitus (permanent ringing in the ears). 
 
The level at which employers much provide hearing protection and hearing protection zones is 
now  85  decibels  (daily  or  weekly  average  exposure)  and  the  level  at  which  employers  must 
assess the risk to workers’ health and provide them with information and training is now 80 
decibels. There is also an exposure limit value of 87 decibels, taking account of any reduction 
in exposure provided by hearing protection, above which workers must not be exposed. 
 
To help you calculate your workers’ exposure, Ultrawave publish the noise generated by your 
ultrasonic cleaner on the Certificate of Test. The figure is that experienced by a worker standing 
in the operating position.  
 
The full test of the Control of Noise at Work Regulations 2005

[2]

 

 
Guidance on the 2005 Regulations can be found in HSE book ‘Controlling Noise at Work’

[3].

 

 

[1] 

http://www.hse.gov.uk/noise/regulations.htm

 

[2] 

https://www.legislation.gov.uk/uksi/2005/1643/contents/made

 

[3] 

https://books.hse.gov.uk/bookstore.asp?FO=1356943&ACTION=BOOK&PRODUCTID=9780717665679

 

 

Summary of Contents for hygea d3ntal

Page 1: ...Operator Instruction Manual ...

Page 2: ...16 During Operation 17 Successful Completion of Cycle 17 Basket Draining 18 Programming Options 18 Setting the Temperature 19 Setting the Cycle Time 19 Setting the Power Level 20 Setting the Frequency Leap 20 Advanced Menu Options 21 Using the Ultrawave Cycle Validation Software 24 Firmware Updates 25 Periodic Testing and Validation 27 Specifications 28 Dimension 33 Maintenance Troubleshooting 34 ...

Page 3: ...m of the cleaning tank Always use a basket or instrument cassette to support items to be cleaned Not doing so may damage the bath and invalidate your warranty Care should be taken when operating the bath at temperatures higher than 54 C as external surfaces may become hot Never use toxic flammable acidic caustic or corrosive solutions in the bath Do not move the bath when it is full of water Befor...

Page 4: ...r or moderate injury It may also be used to alert against unsafe practices Equipment Alert Indicates a potentially hazardous situation which could result in equipment damage Shipping Symbols Proper shipping orientation Keep dry Fragile Catalogue Number Date of Manufacture Serial Number Manufacturer Transportation Storage Conditions Ambient Temperature Range 20 C to 45 C Relative Humidity 10 to 90 ...

Page 5: ...upplier immediately Parts Accessories Included with the hygea d3ntal QTY Three Tier Basket Carrier 1 Instrument Cassettes 2 Basket Tray 2 Basket Clip 1 Lid 1 Hose Connector 1 Drain Hose 1 Power Cable 1 Quick Guide 1 Sonozyme 3 250mL Sample Bottle 1 Wireless USB Dongle 1 For additional accessories please visit the Ultrawave website www ultrawave co uk ...

Page 6: ...ftware Note Please ensure that you have user rights to install the software If not please contact your network or IT administrator 1 Click on the download link 2 Once the file has downloaded right click on the file and select extract all 3 Follow the prompts until the extraction is complete 4 Open the folder and double click on the msi file to run and install Drivers If the software does not run c...

Page 7: ...on low power radio waves to transmit validation data therefore it can be susceptible to interference Please ensure all radio interference is kept to a minimum within the vicinity of the unit If connection to the PC dongle is interrupted your hygea d3ntal will store the cycle validation data in its internal memory Your hygea d3ntal will display a warning after 500 cycles as the internal memory fill...

Page 8: ...Page 7 of 41 Positioning the hygea d3ntal cont Please see the below tips for positioning of the hygea d3ntal ...

Page 9: ...ower on Once the power is on please ensure the following screen is observed 2 The hygea d3ntal will then scan and find the USB Dongle 3 If the USB is found the following screen will be displayed 4 If any cycle validation records are stored within the hygea d3ntal these will then be transferred to the PC at the end of each cycle 5 The hygea d3ntal is now ready to use and will store data ...

Page 10: ...nfirm the wireless USB dongle pairing described in the following section Wireless USB Dongle Pairing Each machine should already be pre paired with the dongle supplied if not then ensure the Validation Suite is open on your PC or tablet with the dongle connected into it 1 Power up the machine and the following screens are displayed 2 Press the arrow key to confirm YES and the following screens are...

Page 11: ...m left hand corner If multiple dongles are displayed then select the correct one by using the keys on the controls of the machine Once the correct one is selected then press the Menu key and the machine should then display 4 A request is then sent to your PC press the ACCEPT key as displayed below and the pairing is complete Please note that this must be done promptly or it will time out and you w...

Page 12: ... machine whilst holding the key the screen below is displayed Follow the same instructions as the previous section on Dongle Pairing Controls Indicators The different keys perform the following functions KEY 1 Starts and ends the ultrasonic cycle KEY 2 Menu Scroll through the menu KEY 3 Up On Yes Adjust the settings in the options menu KEY 4 Down Off No Adjust the settings in the options menu ...

Page 13: ...d become overloaded 3 Connect one end of the drain hose to the hose connector and locate the other end over a drain or sink Shorten hose if required 4 Connect the power cord into a suitable outlet 5 Ensure that the power plug and the switch are accessible 6 Make sure the drain valve is closed Connecting the Power Cord 1 Plug the power cord into the main power connection located on the back of your...

Page 14: ...then illuminate 5 Run degas cycle A B Equipment Alert If the liquid level is too low i e below the Fill To line You will not be able to run a cycle until the tank is properly filled The following warning will be displayed Sonozyme 3 Sonozyme 3 is the recommended detergent to be used with the hygea d3ntal As the detergent is an essential part of the cleaning process a reminder screen will be displa...

Page 15: ...s below the Liquid Level Sensor or if new liquid has been added or changed the option to degas your hygea d3ntal will appear 2 Prior to starting the degas cycle remove all instruments and make sure the unit is filled with liquid and the required dose of Sonozyme 3 3 Place the lid on the hygea d3ntal 4 Select the YES key to start the degas cycle The screen below will display 5 Wait 5 to 10 minutes ...

Page 16: ...t and the operator will be notified should the cycle be interrupted by lifting the lid A cycle cannot be started without the lid in place The following screen will be displayed if the lid is not in place Once the lid is in place the screen will alternate with either of the following displays giving a water temperature status OR ...

Page 17: ...hygea d3ntal cleaning cycle time has been factory pre set to 10 minutes Some instruments may take longer or shorter to clean effectively depending on the level of contamination To adjust the cycle time refer to adjusting the cycle time section Caution Always rinse and inspect your instruments to ensure all debris has been removed prior to sterilisation Equipment Alert Heating the water in the bath...

Page 18: ...oo hot The hygea d3ntal will automatically abort the cycle and you will receive an ABORT OVER TEMP message refer to the troubleshooting Successful Completion of Cycle 1 2 On successful completion of the cycle the below message will display until the operator presses OK 3 Remove the basket from the bath rinse and inspect after cleaning 4 Your hygea d3ntal remembers the set parameters from the previ...

Page 19: ...he set parameters from the previous cycle 1 To access the options menu and scroll through the various changeable parameters press the MENU key when the main screen below is displayed 2 To scroll through the menu press the MENU button 3 When you exit the Programming Options DO NOT SWITCH THE MACHINE OFF you must start a cycle for the new settings to be saved Once saved the new settings will be used...

Page 20: ...When the desired temperature has been selected use the MENU key to move to the next screen During normal operation ultrasonic energy will heat the cleaning liquid by up to 15 C per hour Your hygea d3ntal cannot cool the cleaning liquid If the liquid temperature becomes too hot you must either let it cool down or refill the bath with cooler water Setting the Cycle Time Your hygea d3ntal enables the...

Page 21: ... Frequency LEAP technology provides more homogeneous ultrasonic cleaning activity throughout the whole bath Using advanced software and generators the hygea d3ntal uses Frequency LEAP to create a pseudo random leaping action between a wide frequency range reducing standing waves and improving the cleaning action Your hygea d3ntal has a factory pre set with the LEAP function ON The ON setting means...

Page 22: ...ea d3ntal ultrasonic bath and the version of software The software version implemented on your bath may be different to that shown Note The Serial Number is also located on the label at the back of the hygea d3ntal Setting the Time and Date 1 To set the date and time press the SET button 2 The figures will flash and you can use the or to adjust date or time Press MENU to move to the next figure IM...

Page 23: ...ycles aborted by the operator or because the liquid level was low This example shows the hygea d3ntal has started a total of 12 cycles since new Sleep Mode The hygea d3ntal can be set to low power mode to minimise energy consumption when not in use During sleep mode the hygea d3ntal uses less than 10 Watts of power per hour The hygea d3ntal is factory pre set with sleep mode off Pressing or will i...

Page 24: ...e without the lid in the validation mode Press the start key the ultrasonics will operate for 60 seconds A countdown will be displayed to indicate the remaining time Do not use this mode to perform the Cleaning efficacy test use a normal user cycle Once the timer reaches 0 seconds the ultrasonics will switch off automatically To stop the validation at any time press STOP To advance to the next scr...

Page 25: ...ult the live cycle data screen will appear first Please note this screen will only show data from the last 7 days 3 If you need to print a record please highlight the relevant row by clicking once and press print record 4 If you need to open a validation record please double click on the relevant row to see a more detailed view ...

Page 26: ...pdates 1 If there are updates for your unit you will be notified via email and these can be downloaded from the Ultrawave website To ensure you receive these updates please register your device at www ultrawave co uk pages warranty registration 2 Download the firmware update onto your PC in a safe location 3 Click the Load File in the Ultrawave Validation Software and navigate to the firmware file...

Page 27: ... bath 7 Follow the hygea d3ntal on screen instructions which will install the updates 8 The downloading screen will appear Please do not switch the power off during this process 9 Once the update is complete the hygea d3ntal will return to the start menu ...

Page 28: ... Activity Meter available from Ultrawave If there is no access to the Activity Meter this test should be replaced by the aluminium foil ablation test Quarterly tests carried out by the operator Estates department Ultrasonic activity test using the aluminium foil ablation test available from Ultrawave Annual Validation Tests carried out by Ultrawave approved engineer A combination of tests ensuring...

Page 29: ...F A HIGHER RATING Ensure that excess power cable is stored neatly 230V Electrical Details Power supply 230VAC 50Hz Ultrasonic Frequency 32 to 38 kHz Heater Range 5 C to 55 C Pollution Degree 2 Installation Category II NOTE Supply voltage fluctuations are not to exceed 10 of the nominal supply voltage Standards BS EN 61010 1 2010 Safety requirements for electrical equipment for measurement control ...

Page 30: ...Class B The Ultrasonic Cleaning Bath uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment Radiated Emissions EN 55011 2007 Group 1 Class A The Ultrasonic Cleaning Bath is suitable for use in all establishments other than domestic and those directly connected to the public low voltage power ...

Page 31: ...adiated maximum output power of transmitter W Separation distance according to frequency of transmitter M 150 kHz to 80 MHz d 1 2 x P 80 MHz to 800 MHz d 1 2 x P 800 MHz to 2 5 GHz d 2 3 x P 0 01 0 12 0 12 0 23 0 1 0 37 0 37 0 37 1 1 2 1 2 2 3 10 3 7 3 7 7 4 100 12 12 23 The transmitter rated at a maximum output power not listed above the recommended separation distance d in meters m can be estima...

Page 32: ...04 2 kV L N E 2 kV L N E The quality of the power supply should be that one of a typical commercial or clinical environment Surge Immunity EN 61000 4 5 2006 0 5 1 2kV L E N E 0 5 1kV L N 0 5 1 2kV L E N E 0 5 1kV L N The quality of the power supply should be that one of a typical commercial or clinical environment Magnetic Field Immunity EN 61000 4 5 2006 3A m 3A m Power frequency magnetic fields ...

Page 33: ...ts W according to the transmitter manufacturer and is the recommended separation distance in meters m Conducted RF Immunity EN 61000 4 6 2007 3V 80 1kHz AM 0 15 80MHz 3V 80 1kHz AM 0 15 80MHz NOTE 1 At 80MHz and 800 MHz the higher frequency applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures and people...

Page 34: ... Dimensions mm Tank Internal Dimensions mm Carrier Internal Dimensions mm A B C D E F G X Y Z 345 285 320 265 280 230 150 230 180 90 Working Capacity L Tank Capacity max L Total Power W Ultrasonic Power W Heating Power W 9 5 10 350 100 150 ...

Page 35: ...onic activity by vibrating at very high speeds If any contaminants are in contact with the bath they act as an abrasive causing wear on the metal surface In extreme cases the bath will develop holes and start to leak Cleaning Efficacy The cleaning efficacy of your hygea d3ntal is affected by several parameters Water temperature your hygea d3ntal should operate at 30 C Detergent dosing use Ultrawav...

Page 36: ...ow the required level during operation the cleaning cycle will stop and the following screens will appear If the unit is not running at the time a Fill Tank message will appear instead of an abort NOTE This will record the abort in the validation software Solutions Fill the hygea d3ntal with water so that it is above the liquid level sensor inside the bath If you are using normal water ensure that...

Page 37: ... disables a cycle from starting The most likely cause is the liquid evaporating when the level sensor is switched off Switch the hygea d3ntal off allow the unit to cool for a few minutes top up the liquid above the level sensor and switch the unit back on ABORT LID OPENED To ensure that the operator is aware in the event of cycle disruption the following screen will be displayed if the lid is remo...

Page 38: ...replaced or repaired free of charge at their discretion The warranty is extended to 5 years on the ultrasonic transducer bonding process If the transducers or bonding material are exposed to liquid or cleaning chemicals the warranty will be invalidated The warranty does not apply to normal wear and tear damage caused by misuse non observance of maintenance service or connection instructions damage...

Page 39: ... in additional charges or the equipment being returned to the user sender at Ultrawave s discretion Ultrasonic baths which have been used in medical healthcare applications should be decontaminated packaged in accordance with MHRA guideline document DB2003 5 Management of Medical Devices prior to Repair Service or Investigation This can be found at www mhra gov uk This policy is designed to protec...

Page 40: ...ith the ability to clean up to 60 instruments at once A choice of mesh trays or cassettes can be selected Ultraclean M2 detergent A non enzymatic detergent packaged in boxes of 6 x 1 Litre bottles Hygea Ultrasonic Validation Kit A complete Validation kit providing all the material required for weekly monthly and periodic testing Hygea Ultrasonic Activity Meter An Activity Meter which indicates the...

Page 41: ...t assess the risk to workers health and provide them with information and training is now 80 decibels There is also an exposure limit value of 87 decibels taking account of any reduction in exposure provided by hearing protection above which workers must not be exposed To help you calculate your workers exposure Ultrawave publish the noise generated by your ultrasonic cleaner on the Certificate of...

Page 42: ...21 Ultrawave Ltd Eastgate Business Park Wentloog Avenue Cardiff CF3 2EY UK Ultrawave baths are manufactured in the United Kingdom Ultrawave baths are manufactured to exacting standards and conform to international standards www ultrawave co uk ...

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