Hygiene concept
Contents
1. E 14 Patient specific device Settings essssssrrrrrrrrerrrerererrrrrrrsrrrrrrrrrsrsrsrsrtrererersrsrrrerererenro 14 Resetting device to factory sSettingS s sssssesererersrerrrrrrrsrsrrrrrrrsrsrsrsrsrererersrsrrrererererro 14 Checking electrical safety of power supply UNIt s sssssisssrsrrirrrsrrrrrrrrrerrrrrnrrrernrnrsrerererene 14 EO US E e A E A wre att A E E T E T 14 DISPOSA een a EEE E N E E E 15 Dvice and COMPOSING sainndiat asad vpccs crass s e ative Eire aiae OTN E AEE e 15 FC NN esas es cers 5a ctw ect oe eter E E age se ateate ns oaeon tance eeaneas sane 15 bss LS gt chen ae aan en eee E enn ee re ee ee eee eee 15 Accessories anq wear 6 2 kc een nn nee een ee ene ee eee eee ee eee 15 Dispatch instructions for contaminated GOVICCS ycwiiscdeurssanacviiengunawoyinncanniivaenguwiewteansumaeane 16 So ae aE N E E E E E E E er 16 Paer T F GIG Oa a E E E E ens 16 B ocne p EE T E EE E N EEE EE E A E T 16 1 SYMBOLS IN HYGIENE CONCEPT Important information is denoted by symbols in this hygiene concept Be sure to follow these instructions in order to avoid accidents personal injury and material damage In addition the local accident prevention regulations and general safety regulations in force in the area of use must be observed Ar This symbol denotes general safety instructions Follow these instructions to avoid accidents personal injury or material damage 44 CAUTION This symbol denotes hazardous2. HOFFRICHTER Quality makes the Difference E E E m y gt 3 gt U gt C O e ay lt MTI _ a ay lt MTI _ Y N O Q Q Y Qo O Hygiene concept Instructions for hygienic preparation CONTENTS 3 1 3 1 1 3 1 2 ey 3 3 3 4 4 1 4 1 1 4 1 2 4 1 3 4 1 4 4 1 5 4 2 4 3 4 4 4 5 4 5 1 4 5 2 4 6 4 4 8 4 9 4 10 4 11 4 11 1 4 11 2 4 12 4 13 5 1 Di 5 3 5 4 6 1 6 2 6 3 Symbols in hygiene concept cttteetexeancncbaanecinoueteunesiteunanetnatictaumenandbranednmoritactatatonoentantioeted 3 SA AMON E E E A E A E E E uicoeue sacks 3 Preparation for a patient change snicsevsiwnceusseuancrbnanivasnwasvluadseustnwreammueteniavnndeenaeimecdneinarendan 4 EA E E nace E T A T E E AEE AAS E T AEE E E 4 Fou aoe POUC sre EE E E EEN E EN 4 Information when using a bacterial NING ec ncc cece benscsnsscececaenedidsacvensctusaleceedddeadersneesmsecnsdobects 4 Delivery checking and acceptance of devices DY Service ersrsrsrrrrrrsrrrrrrrrrrrrnrrrrrrrereo O Preparation procedure 1 Manual CFE Dal ANON cies ssaxaccdiwansiearmrennsewnaineinessntinnesondensanentasaawac 5 Validated preparation procedure 2 KR1000 KEredUSy cccccceeseseeeeeeeeeeeeeeeeeeeeeeeeaeenes 5 Preparation saeco atte ere sieescce cyan wien ted btsncparaet teste migidi panontets siomnre art siete ow conn siomatbteinaverntennenesateswirnaniies 6 FVM SECS a gaereas consonant R ato E A ie
3. S1110 multi silicone grease to the rear of the air outlet 9 Fit the air outlet and the on off key 10 Position the cover for the blower box Fix the cover for the blower box in place with the 4 Phil lios head screws 11 Position the controller circuit board and fix the circuit board in place using the 5 screws 12 Insert the power supply unit 13 Connect all electric cables DC jack motor RS232 connector heating connector SD card con nector and the pressure measuring tube to the controller circuit board and check for secure positioning Check that all cables and tubing are protected from tension compression and clamping 14 Insert the design element 15 Fit the button plunger and the on off key 16 Fit the upper case of the housing onto the lower case and turn the device over 17 Use the 4 Phillios head screws to fix the upper case of the housing to the lower case 18 Insert a new filter cassette into the filter frame cover 19 Insert the filter frame cover with the new filter cassette into the device 4 8 ADU TEST AND CALIBRATION Carry out the ADU test and if necessary calibration according to the TREND II service manual 4 9 CHECKING BUTTON FUNCTIONS 1 Check that the blower switches on and off properly when the on off key is pressed 2 Check that all keys function properly They must not jam and should return to their original position after being pressed 3 Insert the humidifier until it perceptibly click
4. al interface USB port e RS232 connecting cable with USB to serial converter optional e HOFFRICHTER TRENDset PC software art no 0000 7142 e Service manual user s manual CAUTION All tools measuring equipment and aids possibly exposed to contamination must be cleaned after they have been used and treated with disinfectant 4 1 38 UNPACKING AND DISINFECTING A CAUTION To protect against germs the surface of the device and where present the humidifier must be treated with a disinfectant immediately after unpacking 4 1 4 CHECKING FOR EXTERNAL DAMAGE Before starting the service check the device and where present the humidifier for external damage 4 1 5 DETERMINING THE BLOWER RUNTIME If you wish to reuse the old blower box for preparation you must first determine the motor runtime of the blower box 1 Connect the device to the power supply Use the PC cable to connect the device to the PC Start the TRENDset PC software and open the connected device under Found devices Select the view Times and Counters Note down the current blower runtime on the supply slip label F13 10 oS oe i PATIENT NAME DEVICE SER NO MOTOR RUNTIME Exchange carried out by NAME SIGNATUR Fig 2 Label F13 10 4 2 CHECKING DISPLAY AND CONTRAST 1 Press any key The display lights up with a brightness of 100 Check the display to see whether all characters are shown correctly and complete 3 T
5. ase of housing see Fig 15 a e Filter cassette area of lower case of housing see Fig 16 b e Measuring tube connection see Fig 16 c e Filter frame cover e Air outlet e Humidifier unlocking button Carry out disinfection as follows 1 Apply disinfectant spray to the components In area of the measuring tube connection spray directly into the opening 2 Allow the disinfectant to act according to the manufacturer s instructions 3 Turn over the upper and lower cases of the housing after spraying to allow the disinfectant to run off 4 Remove any residue with a dry dust free cloth IMPORTANT Allow components to dry completely in the air before assembling the device Fig 15 Upper case of housing Fig 16 Lower case of housing with measuring tube connection 4 5 2 HUMIDIFIER Dismantle the humidifier 2 Remove any limescale residue from the humidifier using a mild descaler e g 5 solution of vinegar 3 Wash out the humidifier thoroughly 4 Disinfect the humidifier Fig 17 Cleaning and disinfection of humidifier 4 6 INFORMATION ABOUT BLOWER BOX In the course of hygienic preparation you can either fit a new blower box from the hygiene kit or send in the old blower box for preparation to HOFFRICHTER GmbH IMPORTANT Preparation of the blower box may only be carried out by HOFFRICHTER GmbH Preparation may only take place when the blower runtime lt 7000 hours and the device is not contami n
6. ated with nicotine 1 Fill out the label F13 10 see Fig 18 to document the blower runtime and affix to the blower box see Fig 19 Also copy the data to your records PATIENT NAME DEVICE SER NO MOTOR RUNTIME Exchange carried out by NAME Vor A F SIGNATUR Fig 18 Label F13 10 Fig 19 Affixing the label F13 10 2 Send in the blower box for preparation to HOFFRICHTER GmbH 3 HOFFRICHTER will then return the hygienically prepared blower box The blower box displays the label F13 06 see Fig 20 HOFFRICHTER Quality makes the Difference m m m m Mettenheimer Str 12 14 19061 Schwerin Hygienisch aufgearbeitet von am Motorlaufzeit Freigabe ja O nein OU Fig 20 Label F13 06 4 7 ASSEMBLING THE DEVICE t When installing a new blower box enter the serial number of the new box in the repair order i Fit the pressure measuring tube from the hygiene service kit onto the connection for the pres sure measuring tube Insert the blower box into the lower case of the housing Position the motor cable and align carefully Fit the motor cable clamp ao SS Slide the sealing gasket for the humidifier lock lever gray and then the sealing gasket for the air outlet black from the hygiene service kit onto the air outlet 7 Press the humidifier unlocking button onto the air outlet The unlocking button should then snap into place behind the brackets Apply a thin layer of OK
7. cal safety In the course of automatic checking by a device safety tester the power supply unit is tested according to VDE 0751 1 DIN EN 62353 2008 as a power supply unit belonging to protection class Il The probe used to measure the device leakage current is connected to the GND of the DC input This is electrically connected to the secondary side of the power supply unit 4 13 FINAL STEPS After finishing work perform wipe disinfection of external surfaces After finishing the preparation work draw up a final report and affix a test seal showing the date and tester s initials to a suitable position on the device Until dispatch store the device and blower box safely away from soiling and contamination from human pathogens by placing in a sealed tear proof plastic bag 5 DISPOSAL Proper disposal saves natural resources and prevents harmful substances being released into the environment 9 1 DEVICE AND COMPONENTS The device and its electronic components must not be disposed of with household waste They must be disposed of at a communal collection point or public waste disposal authority 5 2 PACKAGING Packaging may be disposed of with normal household waste or at a communal collection point 5 3 BATTERIES Batteries must not be disposed of with household waste They must be returned to the distributor or disposed of at a communal collection point 5 4 ACCESSORIES AND WEAR PARTS Disposal of accessories such as tubing mas
8. ected by a patient change other medical devices other accessories other products must be packaged separately on return to the client and identified accordingly as not having undergone preparation 3 1 2 INFORMATION WHEN USING A BACTERIAL FILTER A bacterial filter is used with respiratory therapy devices and ventilators to filter respiratory air in order to prevent contamination of the devices It is connected between the device and the tube sys tem Proper use of a bacterial filter subject to compliance with the service time while the device is used on the patient ensures that the patient will be protected from germs It is the responsibility of the operator to assess the risk of possible contamination and decide about the necessity and method of preparation to be used on the device for a patient change 3 2 DELIVERY CHECKING AND ACCEPTANCE OF DEVICES BY SERVICE The customer s documents accompanying the device must be checked before commencing prepa ration It should be checked whether the dispatch instructions for MRSA contaminated devices see section 6 on page 16 were observed The preparation of MRSA contaminated devices may only be carried out by HOFFRICHTER GmbH or by other companies certified for this purpose Comment In the case of devices used solely for stationary applications where necessary the operator must draw up a separate risk assessment depending on the type and level of contamination define the method of prepa
9. ee make eaanessacuctuis sian eaeeraoet medians baaaass 6 Protective agents and disinfectants sesame ances cian sueneaaciesntent annepeesanennes geste axceranbaeantnnadest etuareennes 6 Tools measuring equipment and GIGS s ensuserrrersrsrrrrrrsrersrerrrrrrsrrrsrrrrrrrrsrrrrrrrrrrersrrrnro 6 JDI ONA diS eC U een ene E E ERN Checking for external damage ccccceccseceeceeceeeneeeceeeeeeeeee eee eeeeeeeeeeseeeeeeaesaeseeseeseeeaeeaesanees T Determining the Blower runt serseri ecnin iE A EaR 7 Sace alee l c e EEES Wiig oie ene tt tte ne tener eee E nn en eee ee 7 o 2 all aie igs QOV O eee eee ne ere te ere nme ome ne fe ert Mir er ee ieee een eee eRe ee ere ee 8 D clentsiaidlighe TMe DOW ole Cermeemene peter mate nen ment he en etter ena cement nae ner heen eter et eee 8 CIE ai MG and OIIG IN CON eesis n R NISE E aN sienna ear debaes 9 Bc cc Rene et ee ee ee ee ee ee 9 FFL TOA CHT eTA sarc ence aan ei E E E A EAE ob EEEE E 11 PN TADOU ONT DOK ea ecancewinnd eh duasaatiaacswecnapendnacaaneesinat 12 Assembling the device sssssessrsnsrssrrrrrrsrsrsrsrsrersrsrsrrrrrrernrnrrirrrararnrnrrrerarnrnrarererrrrrerne 12 ADU testand callib AO Mss ganaaade asians iiaii ie Ea AES RTA OIN AEA a o Eat 13 Cie CI TCD DUHOM TUNC HON seri erate crete aE EEE EEEE ERE EEEE E OERE EREE 13 Resetting counters Setting date ANC time s ssssrererrrrrsrsrrrrrrrsrsrsrsrsrererersrsrrrererererro 14 ES VIC Set WN se sren crete E E E E T A E
10. giene concept Special hygiene measures are advisable when performing maintenance or repairs on devices contaminated with MRSA methicillin resistant Staphylococcus aureus In this case protective clothing such as disposable gloves mask and disposable apron should be worn without fail Hygienic preparation according to the validated KR1000 Keredusy preparation procedure must be carried out before performing maintenance or repair 3 PREPARATION FOR A PATIENT CHANGE The manual procedure to be used for preparation of the TREND II device for a patient change is described below The number of preparation cycles is not limited This procedure may only be car ried out by companies with an appropriately certified quality management system and qualified authorized and experienced specialist personnel Every repair service or inspection etc includes the preparation of devices in the form of surface dis infection In the event of device preparation for a patient change additional disinfection measures are neces sary and are described below This procedure must be observed without fail 3 1 GENERAL 3 1 1 REUSABLE PRODUCTS Reusable products Such as tubing masks water traps particle filters etc can be disinfected according to the manufacturer s instructions However these products do not generally undergo preparation at HOFFRICHTER s Service depart ment Devices not intended for reuse and where relevant other products aff
11. he background of the display is illuminated and the display should be clearly legible in day light 4 After 15 seconds the display fades to the basic brightness level selected in the device menu O 100 The display should still be clearly legible If required the display contrast can be adjusted with the device open see service manual hi a 4 3 OPENING THE DEVICE Unplug the power plug Remove the humidifier where present Take out the filter cassette and remove the filter frame cover of the filter cassette Dispose of the old filter cassette Fig 3 and Fig 4 Place the device top down on a soft base and release the four screws on the housing using a Phillios Screwdriver Fig 5 Then stand the device upright again and remove the upper case of the housing Fig 6 Remove the design element Fig 7 and the button plunger on off key 4 4 DISMANTLING THE BLOWER BOX 1 ao ee Detach all electric cables DC Jack motor RS232 connector heating connector SD card con nector and the pressure measuring tube from the controller circuit board Release all screws from the controller circuit board Fig 8 Remove the power supply unit and the controller circuit board Fig 9 and Fig 10 Release the 4 Phillios head screws on the cover of the blower box and remove the cover of the blower box Fig 11 Remove the air outlet in combination with the humidifier unlocking button the pressure switch and the on
12. ikrozid AF Liquid e Surface disinfectants e g Mikrozid AF e Inthe case of medical devices exposed to hazardous contamination MRSA additional protec tive clothing such as disposable gloves a mask and a disposable apron and goggles should be worn IMPORTANT Where possible wipe disinfection is preferable to spray disinfection 4 1 2 TOOLS MEASURING EQUIPMENT AND AIDS e Device with power cable art no 31100015 e Soft base e lwo different sizes of Phillios screwdrivers e Flow resistor 6 mm with measuring tube art no 0000 7302 e Compressed air spray or stationary compressed air connection e Vacuum cleaning device e Hygiene service kit art no 0000 2568 1 complete blower box replacement for hygienic preparation necessary with patient change art no 0000 2660 1 sealing gasket for air outlet art no 4210 0938 1 sealing gasket for humidifier lock lever art no 42100727 1 pressure measuring tube art no 4500 0014 1 filter cassette art no 0000 2058 1 supply slip label F13 10 e PC with following system requirements minimum requirements MS Windows XP Vista or 7 AMD Athlon Pentium class x86 clock frequency gt 700 MHz Fig 1 Hygiene service kit 512 MB system memory recommended Min 400 MB free hard drive space Microsoft NET Framework 2 0 Redistributable x86 2 MB graphics card min High Color 16 bit Mouse 1 free seri
13. k filter cassette and wear parts e g sealing gaskets and other replaced components must be carried out according to the statutory provisions in force at the area of use This alSo applies to contaminated accessories 6 DISPATCH INSTRUCTIONS FOR CONTAMINATED DEVICES The dispatch instructions apply to contaminated medical devices delivered to HOFFRICHTER GmbH for preparation 6 1 COLLECTION The contaminated medical device is collected from the patient by the distributor medical technician or authorized personnel This involves on site surface disinfection of devices and accessories with Mikrozid Liquid Spray MRSA active followed by careful bagging while wearing disposable gloves a mask and a disposable apron The proper disposal of non reusable materials according to the regulations must be ensured 6 2 PACKAGING FOR DISPATCH The distributor or Service departments packages the device accessories in sterile welding film fol lowed by heat sealing or packaging in PVC or PE bags tear proof closed off with tape or cable ties Power cables therapy accessories user s manual and other accessory articles with a minimal risk of infection must be disposed of according to the regulations Note ATTENTION CONTAMINATED DEVICE or ATTENTION MRSA CONTAMINATED DEVICE must be clearly displayed in the packaging The packaging should be sturdy and of the correct tyoe and must not be contaminated Cardboard boxes must be carefully sea
14. led with packing tape 6 3 DISPATCH The delivery note must be affixed to the outer packaging of the device delivery note to state ATTENTION CONTAMINATED DEVICE or ATTENTION MRSA CON TAMINATED DEVICE Shipment is effected via logistics companies HOFFRICHTER GmbH C Mettenheimer Strasse 12 14 0123 19061 Schwerin Germany Phone 49 385 39925 0 Fax 49 385 39925 25 E mail info hoffrichter de www hoftrichter de TREND Il hygiene eng 22091 1 02
15. off key Fig 12 Dismantle the unlocking button Remove both sealing gaskets from the air outlet and dispose of them Remove the motor cable clamp Fig 13 Remove the blower box Fig 14 O Remove the pressure measuring tube from the pressure connection 4 5 CLEANING AND DISINFECTION 4 5 1 DEVICE 1 Electronics mounting Yes Optional 2 Spring plates of air outlet Yes Optional 3 Button plunger on off key Yes Optional 4 Motor cable clamp Yes No 5 Controller circuit board No Yes No 6 Design element Yes Optional 7 Contact sockets for humidifier Yes Optional 8 Cover for blower box Yes Optional 9 Top section of housing Yes Yes partially 10 Upper case of housing Yes Yes partially 11 Measuring tube connection No Yes Yes 12 Filter frame cover Yes Yes 13 Air outlet Yes Yes 14 Humidifier unlocking button Yes Yes Information about cleaning All components with the exception of the circuit boards can be cleaned using a damp cloth and a solution of soapy water in a standard concentration Use compressed air to clean the controller circuit board and areas which are not readily accessible and remove loose particles with a vacuum cleaning device IMPORTANT Allow components to dry completely in the air before assembling the device Information about disinfection All components acting as air ducting must be treated with a disinfectant Components which act as air ducting include e Filter cassette area of upper c
16. ration for use on another patient and specify this in the accompanying documents This applies in particular to cases of possible contamination with MRSA or comparable contamina tion of a device 3 3 PREPARATION PROCEDURE 1 MANUAL PREPARATION IMPORTANT The manual procedure must not be used for the preparation of MRSA contaminated devices This hygienic preparation procedure with a patient change may only be carried out by companies with an appropriately certified quality management system and appropriately qualified authorized and experienced specialist personnel Manual preparation is described in this hygiene concept 3 4 VALIDATED PREPARATION PROCEDURE 2 KR1000 KEREDUSY IMPORTANT The KR1000 Keredusy preparation procedure is suitable for the preparation of MRSA con taminated devices Other procedures must not be used Hygienic preparation with a patient change according to the validated KR1000 Keredusy proce dure may only be carried out by companies with a QM system and appropriately qualified autho rized and experienced specialist personnel The type and scale of the preparation are described in detail in Instruction on dealing with validated respirators for the disinfection system KR1000 The number of preparation cycles for the device is limited to 5 4 PREPARATION 4 1 PRELIMINARY STEPS 4 1 1 PROTECTIVE AGENTS AND DISINFECTANTS e Hand sanitizers e g Sterillium Bode e Disinfectant sprays e g M
17. s into place Release the mechanism by pressing the unlocking button and then detach the humidifier again It should be possible to attach and detach the humidifier with little effort 4 When the humidifier is attached press the heating key on the display to check that the selected heating level is indicated and that the LED lights up 4 10 RESETTING COUNTERS SETTING DATE AND TIME Use the PC cable to connect the device to the PC Start the TRENDset PC software and open the connected device under Found devices Select the view Times and Counters Reset the filter counter Reset the blower runtime Reset the date and time if necessary Click on Send oo oe eS 4 11 DEVICE SETTINGS 4 11 1 PATIENT SPECIFIC DEVICE SETTINGS If you have new patient data select the view Patient Data Enter the new patient data Click on Send to store the settings in the device Select the view Device Settings Select the device settings ao eS i a Click on Send to store the settings in the device 4 11 2 RESETTING DEVICE TO FACTORY SETTINGS 1 If you do not have any patient data or patient specific device settings reset the device to the factory settings 2 Select Communication gt Delete Device Data gt Delete Device Memory and Send Factory Set tings 4 12 CHECKING ELECTRICAL SAFETY OF POWER SUPPLY UNIT The device is equipped with protective insulation and only the power supply unit has to be checked for electri
18. situations that may lead to moderately severe injuries IMPORTANT This symbol denotes information tips and instructions for the efficient error free use of the device 2 SAFETY INFORMATION Before starting preparation read this hygiene concept through carefully Observe the user s manual and the service manual as well as the warning and safety instructions they contain Accessories such as tubing masks microfilters etc are not prepared for a patient change Devices used by smokers do not generally undergo hygienic treatment There is a risk of short circuiting due to the capacitors present in the device Hygienic preparation may only be carried out by qualified authorized and compe tent specialist personnel For hygiene reasons we recommend wearing disposable gloves whenever work ing on the device Before further work the surface of the device must be treated with a disinfectant When doing so observe the manufacturer s safety instruc tions and instructions for use If it is necessary to perform work without protective gloves e g final assembly hands should be disinfected with hand sanitizer before and after work When new goods are received by the Service department the documents sup plied with the device must be checked Devices contaminated with MRSA must be subjected to hygienic preparation according to the validated KR1000 Ker edusy preparation procedure All other devices are prepared according to this hy
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