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TABLE OF CONTENTS

Chapter 1

– Specifications…………………………..7

Intended use and purpose

…..……………………….....7

Advantages for the user

………………………………..7

Chapter 2

– Description of unit…………………….9

Package contents

……………………………………….9

Status bar on display

…………………………………...9

Views of unit

……………………………………………10

Accessories for loading the unit

………………….…..11

Insertable frames and instrument baskets

……….…12

Acoustic signals

……………………………………..…13

Automatic door locking mechanism

………………....14

Emergency release

…………………………………....14

Water softening system

……………………………….15

Chapter 3

– Initial operation………………………..16

Requirements for setting up, installing and
operating the unit

……………………………………...16

Requirements for the location of the unit

…………....16

Connections

…………………………………………….16

Different ways of setting up

…………………………...17

Space requirements

……………………………………17

Topping up regenerative salt

………………………….18

Processing media

……………………………………...19

Filling rinsing agent

…………………………………….20

Dosage

…………………………………………………..21

Turning the HD 450/HD 450 Injection on/off

………...21

Requirements for initial operation

……………………..21

Chapter 4

– Cleaning and disinfecting……………22

Types of loads

…………………………………………..22

Dental transfer instruments

……………………………22

Loading washware

……………………………………..23

Before the start of each program, take note of the
following

…………………………………………………24

Closing the door

………………………………………..24

Starting a program

……………………………………..25

Start time preselection

………………………………...26

When the program is running

………………………....27

End of program

…………………………………………28

Manual program cancellation.

…………………………29

Removing washware

…………………………………..30

Chapter 5

– SETUP-MENU .....................................30

User menu ..

…………….……………………………...31

Admin menu..

…………….……………………………..33

Chapter 6

— Logs..........................................................38

Batch protocol

……………………………………….………38

Using a USB stick as output medium

…………….………39

Computers as output media

……………………….………40

HD450-Printer

………………………………………...….…41

Example of a log record

……………………………..……..42

Chapter 7

– Maintenance…………………………………43

Cleaning

…………………………………………………..….43

Cleaning

the injection filter …………………………………46

Avoiding stains

……………………………………….….…..50

Maintenance

……………………………………………..…..50

(Process) Validation

………………………………………...50

Chapter 8

– Operational breaks…………………………51

Breaks

………………………………………………………...51

Taking the unit out of operation

………………………..…..51

Transportation

………………………………………………..52

Putting the unit back into operation after a move

………...52

Chapter 9

– Function test………………………………...53

Automatic function test

……………………………………..53

Manual function test

………………………………………...53

Tests in daily use

…………………………………………....53

Chapter 10

– Malfunctions……………………………….54

Warnings

……………………………………………………..54

Malfunction messages

………………………………………54

Before calling us

……………………………………………..55

Malfunction messages

………………………………………57

Technical data

………………………………………………59

Operational data

……………………………………………60

Appendix A

– Symbols on the unit……………………..61

Содержание HD 450

Страница 1: ...aning and disinfection unit Like our other products this cleaning and disinfection unit was manufactured and certified according to the strictest quality standards However please read this user manual thoroughly before operating this unit Careful handling and care of the cleaning and disinfection unit helps increase its useful lifespan as well as preserve its value IC Medical GmbH ...

Страница 2: ...location near the cleaning and disinfection unit The user manual is to be regarded as part of the product User Manual valid for HD 450 HD 450 Injection and HD 450 Modul IC Medical GmbH Rudersberg Steinenberg Germany 4nd Edition April 2017 Responsible for the content are IC Medical GmbH Schorndorfer Str 67 73635 Rudersberg Steinenberg Germany E Mail info icmedical de www icmedical de 2017 IC Medica...

Страница 3: ...rder presented Avoid danger Read all safety regulations carefully before using the HD 450 HD 450 Injection Please note the following S y m b o l Meaning Explanation Health risk Indicates a dangerous situation Should insufficient measures be taken to avoid such a situation this may result in minor to life threatening injuries Do not ignore Indicates a dangerous situation Should insufficient measure...

Страница 4: ... instructions provided in their user manuals by the manufacturer of the accessories are to be followed When processing instruments remember to observe the relevant regulations and guidelines such as those from the RKI BfArM DGSV DGKH etc as well as the processing instructions of the instrument manufacturer and the AKI All personnel responsible for the processing of instruments must be properly tra...

Страница 5: ...ow it may also contain processing media in case of damage Always follow the safety regulations provided by the processing media manufacturer Maintenance The maintenance of the unit is to be carried out only by authorized persons Storage and transport Install and operate the unit in a frost free environment Store and transport the unit in a frost free environment Malfunctions Should you repeatedly ...

Страница 6: ...fer instruments 22 Loading washware 23 Before the start of each program take note of the following 24 Closing the door 24 Starting a program 25 Start time preselection 26 When the program is running 27 End of program 28 Manual program cancellation 29 Removing washware 30 Chapter 5 SETUP MENU 30 User menu 31 Admin menu 33 Chapter 6 Logs 38 Batch protocol 38 Using a USB stick as output medium 39 Com...

Страница 7: ...th a chemical cleaning agent Following which a disinfection process utilizing heat takes place When using the HD 450 HD 450 Injection please observe the following Note The HD 450 HD 450 Injection is not suitable for the maintenance of thermolabile Instruments e g flexible endoscopes The HD 450 HD 450 Injection is not suitable for the processing of waste for disposal and in the laboratory environme...

Страница 8: ...e water in circulation is monitored via a sensor At the same time the washing arm and chemicals involved in the process are analyzed Automatic conductivity measurements The HD 450 HD 450 Injection constantly monitors the conductivity of the rinse If the conductivity was too high in the last final rinse a warning message is displayed and the cleaning and disinfection process is marked as being inco...

Страница 9: ...ation logs Declaration of conformity USB stick with recording program Accessories As ordered This cleaning and disinfection unit was extensively tested at the factory and found to be in perfect working condition However it is possible that small water spots remain These will disappear in the first wash cycle Status bar on display Cleaning cycle batch No of cycles to date Network Unit is connected ...

Страница 10: ...necting lead External control panel optional Ethernet network connection RJ45 Cold water connector CW Waste water connector Inside view Connecting port for injector ail HD 450 Injection Water supply port CW FD water Receptacle for salt Washing arm Wide mesh and fine mesh screen Cleaning chamber for processing media Neutralization chamber ...

Страница 11: ...s strainer baskets instrument holders etc in the enclosed accessory list Racks and Instrument baskets Based on this pattern loading is to see how the test tube racks and the instrument basket are preferably to be arranged The baskets must be along and rear hooked into the base rack 1 x Flexio basic basket 1 1 x Flexio inlay basic bastek 1 46 46 1 x Flexio injection bar 8 adapter 1 x Flexio adapter...

Страница 12: ...Flexio tray holder 2 Flexio salver holder Flexio tray holder 7 Flexio universal holder for 4 specula or 11 forceps Flexio universal holder for 8 specula or 21 forceps Service Kit for HD 450 HD 450 Injection Flexio instrument holder ENT 16 Flexio adapter for dental air scalers Flexio universal tube adapter 4 6 mm content 4 pieces Flexio medicinal silicone hose 2 m System separator Aqua stop Flexio ...

Страница 13: ...se are meant to attract your attention and serve to provide you with information In the administrator menu you will be able to configure these signals to suit your needs Signal Meaning Keypress Confirms the correct pressing of a key 20 x 0 5 seconds Program concluded with success 10 x 5 seconds Malfunction error ...

Страница 14: ...or be unlocked and can then be opened To open pull forwards on the door handle WARNING When the program is running the door can only be opened if the program is canceled by the user Never open the door forcefully After the program has been interrupted or ended the door can be opened with the 3 digit personal code Emergency release In the event of a power failure the door of the HD 450 HD 450 Injec...

Страница 15: ...of 22 40 dH For levels higher than 40 dH an external water softening system is required If an external water softening system is used it is sufficient to use the Thermo Tab Art No 100 921 as the processing medium Water hardness is always measured in dH dH mmol l f e dH mmol l f e dH mmol l f e 1 0 2 2 2 15 2 7 27 19 29 5 2 52 37 2 0 4 4 3 16 2 9 29 20 30 5 4 54 38 3 0 5 5 4 17 3 1 31 22 31 5 6 56 ...

Страница 16: ...the treatment location must be at least 1 5 meters in radius Should these instructions not be followed damage to the HD 450 HD 450 Injection and or injury may result Requirements for the location of the unit Location The HD 450 HD 450 Injection is to be set up in a dry and dust free location The humidity at the unit s location is to be 30 60 and the ambient temperature 15 35 C Should this not be t...

Страница 17: ...0 Injection inthefollowingways As a built in unit in a recess intended for this purpose and an already existing continuous work surface Freely positioned in a room on a work surface Space requirements Built in The unit fits into a normal 60 cm recess next to built in cabinets in your practice HD450 HD450 Injection Width A 555 mm 555 mm Height B 450 mm 450 mm Depth C 505 mm 580 mm D 870 mm 940 mm E...

Страница 18: ... receptacle so that the salt dissolves 3 Fill the storage receptacle completely The storage receptacle holds approximately 1 0 kg of salt 4 Ensure that the opening for filling salt is clean from any remaining salt as well as any overflowing brine in order that the cap may be replaced tightly 5 Screw the cap back on WARNING After the initial filling up of the salt receptacle no additional water is ...

Страница 19: ...it in case of a malfunction may also contain processing media Should there be any contact with the processing media be sure to follow the processing media manufacturer s instructions Use only Thermo Tabs Art No 100 921 und IRA salt Art No 103 006 Damage to instruments and the washing chamber may result otherwise Inserting processing medium Open cleaning chamber Insert cleaning tab into the dry cle...

Страница 20: ...y of instruments for use with rinsing agents WARNING If you notice visible streaks on the instruments the cause could be an overdose of cleaning agent If cleaning agent is missing or insufficient the corresponding information will be displayed and you will be prompted to add cleaning agent ...

Страница 21: ...ils staples or similar objects to hold the cord in place Should the power cord or the power plug be damaged cease operation of the unit The power cord and power cable may only be replaced by authorized persons Failure to observe these instructions may result in damage to the cable or plug and or cause a fire or electric shock Serious injury may result Turn on the HD 450 HD 450 Injection by pressin...

Страница 22: ...dpieces and elbow attachments using an adapter Dental transfer instruments Use only turbines handpieces and elbow attachments which manufacturers have approved for use with automatic processing in a cleaning and disinfection unit Be sure to follow the instrument manufacturer s instructions Should there be any undesirable results with the handpieces and elbow attachments even though the manufacture...

Страница 23: ...gram with clean compressed air after which they should be maintained with suitable care products oils Remember to observe your country s local regulations Loading washware In order to load washware you need to insert at least the base rack This is available with an additional injector system for the dental sector Other accessories such as insertable frames instrument baskets washing trays screenin...

Страница 24: ...ments Avoid arranging them such that certain areas do not get sprayed Instruments are not to cover each other All vessels such as glasses dishes etc are to be placed with the opening facing down Objects with openings or recesses should be placed at a slant such that the water can run off Use only undamaged instruments suitable for washing made of instrument steel to prevent corrosion Use thermores...

Страница 25: ...comes on Wait until the HD450 HD 450 Injection is ready Starting a program Never leave the unit unattended when it is running The unattended operation of electrical devices including that of the HD 450 HD 450 Injection is at your own risk The company will not be liable for any resulting damages arising from an unattended operation of the unit ...

Страница 26: ...e you can select the free start time between 1 and 99 hours in the hour rhythm The thermodesinfector then starts automatically at the desired time For a delayed program start select Start time Now you can select any start time After selecting the start time confirm the entry with OK and enter a 3 digit code Once the start time has elapsed the thermodisinfector starts automatically ...

Страница 27: ...e begins The washing chamber is heated continually to a temperature specified by the program and the temperature maintained during the maintenance time The processing medium is added automatically before the maintenance time begins Intermediate rinse An intermediate rinse takes place as a preparatory step before disinfection in order to reduce the concentration of any remaining processing media Di...

Страница 28: ...l the points above are fulfilled and the program has completed without any interruptions or malfunctions the washware has been successfully been cleaned and disinfected End of program From the messages displayed and the beeps emitted you will be able to hear and see when and if a program was completed successfully You then need to enter your personal code to unlock the door which must then be open...

Страница 29: ...ue to safety considerations You will be able to open the door as soon as the temperature in the washing chamber has cooled down to 75 C Manual program cancellation before drying commences If a program is canceled before drying begins the program is to be considered unsuccessful When canceling a program and removing washware please observe the following There is a risk of contamination if the progr...

Страница 30: ...tion may be damaged in the process and or hot steam may be emitted from the unit If these instructions are not followed scalds burns or chemical burns may result Especially large and solid instruments may still be extremely hot after the program has ended Before removing the instruments the instrument baskets and insertable frames allow them to cool If these instructions are not followed scalds an...

Страница 31: ...dministrator menu This is where all the basic settings for the unit are set Accessing the menu Start screen press MENU Enter user code User 3 digits Administrator 6 digits Depending on the code entered the user or admin menu is then displayed User menu User menu Export memory Select whether all or only new Confirmation of export entries are to be exported ...

Страница 32: ...the arrows set the current time and date Press OK to confirm Setting language Now the user can set his or her own language Confirmation message in the selected Press OK to confirm language Note that the language for each user can be set separately ...

Страница 33: ...33 Chapter 6 Logs Administrator menu Administrator menu Add user Enter name and press OK to confirm Enter 3 digit code and confirm with OK entries are to be exported ...

Страница 34: ...hat each user has to have his or her own code Up to 32 users may be added Deleting a user Select desired user and select Confirm delete OK to confirm Confirmation message Edit administrator Enter desired name A code must be provided here Press OK to confirm ...

Страница 35: ...t records are lost Safety warning before format Progress display Confirmation message Network settings Settings available for the network of your practice In the original factory state DHCP is activated and when the HD450 HD450 Injection is connected to the network through the ethernet port the unit will automatically be assigned an IP address from the server The settings may also be entered manua...

Страница 36: ...desired options for your environment Manual filter change Enter user code Confirmation message Records will be kept in memory of who changed the injection filter Removing lime deposits Depending on the hardness of the water you may turn on off the water softening system here For more information refer to chapter 2 Water softening system ...

Страница 37: ...users Exporting transfer data Backup unit settings Confirmation screen No records are backed up with the transfer data This backs up the basic settings users and administrators If the unit has to be reset to factory settings the data can be re imported in this manner If possible back up all data every time a new user is added Importing transfer data Restore unit settings Confirmation screen ...

Страница 38: ...38 Chapter 6 Logs Update firmware Confirm with YES You will then be guided through the menu ...

Страница 39: ...ed cleaning and disinfection process or at a later date e g at the end of an office day in your practice or at a later date of your own choosing You have the option of exporting the logs of the cleaning and disinfection cycles onto the following output media and to archive them accordingly USB stick Computers in the network of your practice Output media may be combined as desired This makes it pos...

Страница 40: ...a USB stick Never use force to insert the USB stick into the USB port Never pull the USB stick out of the port when read write operations are in progress If these instructions are not followed data loss damage to the USB stick and or the HD 450 HD 450 Injection and or its software may result ...

Страница 41: ...up in the status bar Removing USB stick Proceed as follows to remove the USB stick from the USB port Pull the USB stick out of the USB port only when the logs have been fully written onto the USB stick Computers as output media You can access the HD 450 HD 450 Injection directly from the network of your practice For this the HD 450 HD 450 Injection has to be connected via the network connection RJ...

Страница 42: ...tions to import the logs into the program USB stick Save the logs onto the USB stick and insert the USB stick into a free USB port on the computer where the HD450 Printer program is installed The program will recognize the log files on the stick automatically and activate the Import symbol Click on the symbol to transfer the logs onto the computer Network If the HD 450 HD 450 Injection is integrat...

Страница 43: ...43 Chapter 6 Logs Log specimen ...

Страница 44: ...ove it Grab and turn the handle on the wide mesh screen all the way to the left and pull upwards to remove it Loosen and remove the fine mesh screen and if necessary rinse them under running water using a soft brush to remove deposits if necessary Do not use any dishwashing liquid Wide mesh screen fine mesh screen Always ensure that both the wide mesh and fine mesh screens are inserted before star...

Страница 45: ...terior of the HD 450 HD 450 Injection is to be cleaned only with a moist cloth or a suitable cleaner for plastics Please test for any adverse effects before use Never use any solvents or benzene for cleaning Fine dirt particles that were not trapped by the wide mesh and fine mesh screens and have entered the water outflow opening must be removed This becomes apparent e g when the water used for cl...

Страница 46: ...jection filter needs to be changed every 20 cycles This change will be indicated on the display Use only injection filters from IC Medical Art No 105 006 If the injection pump malfunctions change the injection filter and reset the counter Menu option Admin menu manual filter change ...

Страница 47: ...or the HD 450 Injection 1 Remove the injection rail from the basic basket 2 Remove the silicone coupling back to the rail 3 Remove the silicone stopper front on the rail 4 Overview of the required components silicone plugs injection rail filter silicone coupling ...

Страница 48: ...a treatment cycle in a thermal To do this the injection filters in the basic basket and start a cleaning cycle Please note that in this case no handpieces can be prepared 6 Replace the silicone plug back on the rail 7 Press silicon plug on and test it 8 Remove slide into the rail until the filter is completely placed in the rail ...

Страница 49: ...49 Chapter 7 Maintenance 9 Test the position 10 Replace the silicone coupling again 11 guide the silicone coupling must be positioned on the frame of the filter ...

Страница 50: ...50 Chapter 7 Maintenance 12 visual inspection whether the filter is correctly positioned Assembly injection tube in the base rack ...

Страница 51: ...ater quality due to heavy metal or chloride contamination may lead to stains and rust Maintenance www HD450support de Allow only authorized persons to perform the maintenance Process Validation The operator of the practice is responsible for ensuring the error free functioning of the cleaning and disinfection process as well as reproducible results This is a stipulation that comes from e g the med...

Страница 52: ...s Breaks between individual programs are not required After a program has completed or been canceled the instruments can be replaced A program can be started only after the unit has cooled to below 45 C Taking the unit out of operation If you would like to take the HD 450 HD 450 Injection out of operation for a longer period of time e g due to a vacation proceed as follows The interior of the wash...

Страница 53: ...t be followed damage to the HD 450 HD 450 Injection and malfunctions may occur Also note In addition to the instructions for taking the unit out of operation please note the following Empty the unit completely and seal the outlet valve Seal the water supply hoses Remove the base rack and any inserts Close the door Protection from frost The HD 450 HD 450 Injection should be operated stored and tran...

Страница 54: ... the HD 450 HD 450 Injection will display warning messages or fault indicators If necessary it will cancel the program with the corresponding message If the program has completed successfully a corresponding message is displayed Manual function test You have the option of monitoring the values displayed on the screen as well as the progress of the program Additionally with the logs of the program ...

Страница 55: ... order to prevent malfunctions Malfunction messages When safe operation or the cleaning and disinfection cannot be carried out properly malfunction messages will be shown These may appear on the display shortly after turning on the HD 450 HD 450 Injection or when a program is running If a malfunction occurs while a program is running he program will be canceled this will be indicated by an audible...

Страница 56: ...he instruments The water softening system has not been programmed The deposits on the instruments are from the remains of dental cement Check the hardness of the tap water and if necessary reprogram the water softening system Manually clean the instruments before the cement hardens Spots on the instruments Neutralization agent is missing Add rinsing agent Unsatisfactory cleaning results Base rack ...

Страница 57: ... basket inserts or racks not loaded properly or too full Door was closed for a long time after program ended see logs Arrange washware properly and do not overload Dry instruments manually Open the door immediately after program ends Remaining moisture in hollow instruments Dry narrow necked instruments manually with sterile compressed air ...

Страница 58: ...upply hose pinched when setting up Turn on the mains Inspect the screen of the supply hose Check the supply hose along its length 204 Lye pump is blocked Outlet hose pinched outlet valve or hose clogged Foreign object in the lye pump Inspect runoff hose for bends or pinches 205 No processing media found No processing media was inserted Insert Thermo Tab Program must be restarted 206 Injection pump...

Страница 59: ...ions of the processing media manufacturer 302 Fresh water supplied even though inlet valve is closed Inlet valve is defective Immediately turn off water supply 303 Overheating Electronics are defective Contact customer service 304 Temperature too low Heating element defective Contact customer service 305 Circulation pump defective Foreign bodies in pump wheel 306 Temperature sensor Heating element...

Страница 60: ...000 m Installation category 2 Air pressure 75 kPa 106 kPa Connector for cold FD water 3 4 Waste water connector DN21 Water quality Drinking water according to drinking water ordinance TrinkW2001 take note of local regulations Min flow pressure 150 kPA 1 5 bar Recommended flow pressure 250 kPa 2 5 bar Max water pressure 1000 kPa 10 bar Min washing pressure 140 mbar Max waste water temperature 93 C ...

Страница 61: ...rtial cycle Partial cycle Partial cycle Partial cycle Partial cycle Universal program Pre wash 1 Pre wash 2 Cleaning Intermediate rinse Disinfection Drying Amount of water l 1 5 2 0 2 0 2 0 2 0 2 0 Maintenance time min 2 7 7 28 5 18 15 Temperature C 22 22 22 55 22 90 90 ...

Страница 62: ...demands regarding placing on the market redemption and sustainable disposal of electric and electronic devices 0297 By the CE mark of conformity the producer declares that the medical devices comply with the basic demands of the Medical Devices Guidline MDD The 4 digit number implies the control by an authorised certification centre here DQS Icon for producer The name and complete address are stra...

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