Hygiene concept - Hoffrichter GmbH
Contents
1. scot A2020 Em sce If present remove both battery Pull the filter out and dispose Turn the device over and place packs from the device thereot it on a soft surface Pull out all 4 housing feet Step 4 Step 5 Step 6 Julodonbp Undo all 4 housing screws Pull the rear base out com Pull the heating cable off the using the Phillips screwdriver pletely and the front base out humidifier electronics and pull PH1 slightly the front base out completely Step 7 Turn the device over and Push the housing slightly out Pull off all the cable connec remove the top section of the ward using a screwdriver and tions from the controller circuit housing pull the heating cable out of the board Carefully pull the silicone top tubes off the pressure sensor and the microphone cover and dispose thereof Separate the controller circuit board from the top section of the housing by undoing all 5 screws with a Phillips screw driver PHO Step 13 Remove the blower bellows from the housing and take the blower out Step 16 Step 11 Step 12 Undo both screws on the Remove the acoustic hood acoustic hood using a Phillips screwdriver PH1 Pull the Sylomer ring off the Pull the blower bellows with the bottom of the blower and dis safety ring off the room divider pose thereof Step 17 Step 18 Use the point auxiliary tool to unscrew the 4 fixing elements by turning them through 90 in a counterclock2. final assembly hands should be disinfected with hand sanitizer before and after work Upon receipt in the service department the documents supplied together with the device must be examined Devices contaminated with MRSA must be subjected to hygienic preparation according to the validated KR1000 Keredusy preparation procedure All other devices are to be prepared according to this hygiene con cept 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 any maintenance or repair 3 PREPARATION FOR A PATIENT CHANGE The manual procedure to be used for preparation of the point 2 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 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 necessary and are described below This procedure must be observed without fail Devices as well as humidifier s of
3. seal of approval with date and signature of the tester to a suitable place on the device Until shipping of the prepared device store it safe from dirt and contamination with human patho gens in a closed tearproof PVC or PE bag 6 DISPOSAL Proper disposal saves natural resources and prevents harmful substances being released into the environment 6 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 via a public waste disposal authority or as per the requirements of the relevant national law 6 2 PACKAGING The packaging can be disposed of with household waste at a communal collection point or as per the requirements of the relevant national law 6 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 or as per the requirements of the relevant national law 6 4 ACCESSORIES AND WEAR PARTS Disposal of accessories such as tubing masks filter cassettes 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 7 SHIPPING INSTRUCTIONS FOR CONTAMINATED MEDICAL TECHNOLOGY The following shipping instructions apply to contaminated medical technology which is delivered to HOFFR
4. smokers are generally not acceptable for hygienic preparation by HOFFRICHTER service 3 1 GENERAL INFORMATION 3 1 1 REUSABLE PRODUCTS Reusable products Such as tubing masks water traps particle filters etc can be disinfected according to their manufacturer s instructions However these products do generally not undergo preparation at HOFFRICHTER s service department Products not intended for reuse and where relevant any other product affected by a patient change other medical devices other accessories other products must be packaged separately on return to the client and must accordingly be identified as not having undergone hygienic prepara tion 3 1 2 INFORMATION ON BACTERIAL FILTERS 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 installed 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 device will be protected from germs on the patient s side 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 RECEIPT INSPECTION AND ACCEPTANCE BY THE SERVICE DEPARTMENT The customer s documents accompanying the device must be examined before comm
5. 061 Schwerin Germany Phone 49 385 39925 0 Fax 49 385 39925 25 E mail info hoffrichter de Web www hoftrichter de point 2 Hygiene ENG_2012 09 07_03
6. E A E E A E 19 1 SYMBOLS USED IN THIS 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 A WARNING This symbol denotes hazardous situations that may lead to serious injuries or death A CAUTION This symbol denotes hazardous situations that may lead to moderately severe injuries ATTENTION This symbol denotes situations that may lead to material damage or damage to the device NOTICE 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 Also observe the user s manual and the service manual as well as the warning and safety instructions they contain 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 instructions and instructions for use If it is necessary to perform work without protective gloves e g
7. HOFFRICHTER Ee Quality makes the Differ Hygiene concept Instructions for hygienic preparation TABLE OF CONTENTS 3 1 3 1 3 1 2 ey 3 3 3 4 t Fel Si Oai Sel Sel One One 5 3 5 4 9 9 6 eNd 5 8 5 9 5 10 9 11 RON 6 1 6 2 6 3 6 4 7 1 Pac 1 3 Symbols used in THIS hygiene concept vvsiwnicicorsvaveusunnoteednadennureuesidswuncdnieuktaweudevesuuenumieitas 3 SA AMON E A T E A E A A T E sacks 3 Preparation for a patient change sniuseviwnctvsssuaerbnanivnsnwaseluadseastnareamueteniavnnteenaseimrcdeinarbadas 4 SAE ne o E e E E E E A E T EEE E 4 Fao PO UC a rN EE EN EN EN 4 MORTON CH pactornal MTO S ssrcreduScreranancorsaiseeudete enr PENNE SENA TOE EN 4 Receipt inspection and acceptance by the service departMent s sssrererrrrrrrrrrrrrrrrrrrrrn J Preparation procedure 1 Manual Preparation esnsrensnenrrrrrnrsrsrerrrrrrsrsrererrrrrrnrsrrrrrreo 5 Validated preparation procedure 2 KR1000 Keredusy ccccccecseseeeeeeeeeeeeeeeeeeeeeeeeaeenes 5 Exploded view drawing cccccecsececceeeeceececceceecuececeecuecensucueceececuesueseececueseeseseesersesensenses 6 KanalD pr aO a E E AA T BF IN INSU SS E E A E E A A E E AE E E RONE E E NE E E r Protocive dgents and Melis alice gi stare eee aan een renee ene tne ena eee eA T eee Ra 7 TOO Measuring SAUIOMICHIE and AIO S aeaniee enaar aTi Ea EAER TE EEEE 7 Ga stele lt eleesl gekelis gsc a eet tant er nner tc Tr een e
8. ICHTER GmbH for processing 7 1 PICK UP The dealer medical technician or authorised personnel picks up the contaminated medical technol ogy from the patient An on site surface disinfection of the equipment and accessories with mikro zid liquid spray MRSA active takes place followed by carefully placing the objects in bags with the use of disposable gloves mask and disposable apron The proper disposal of disposable mate rials is respected 7 2 PACKAGING FOR SHIPPING The packaging of equipoment accessories in sterile welding foil followed by shrink wrap or packing in PVC or PE bags tear resistant and sealed by tape or cable tie takes place at the dealer s or in the service departments Power cable ventilation equipment user s manual and other accessories with minimal risk of infec tion must be properly disposed of Notice CAUTION CONTAMINATED EQUIPMENT or CAUTION MRSA CONTAMINATED EQUIPMENT must be visibly placed in the packaging The packaging must be proper and robust and must not be contaminated The box has to be con scientiously sealed with packing tape 7 3 SHIPPING The delivery note must be on the outside of the equipment packaging The delivery note must contain one of the following notices CAUTION CONTAMINATED EQUIP MENT or CAUTION MRSA CONTAMINATED EQUIPMENT Shipping takes place by appropri ate logistics companies HOFFRICHTER GmbH Mettenheimer StraBe 12 14 19
9. Slotted screwdriver 06x3 5 2 Phillios screwdriver PHO 3 Phillios screwdriver PH1 4 Adjustment screwdriver 7 e point auxiliary tool art no 0000 7939 5 e Spatula 6 e Flow resistor 6 mm art no 0000 7302 e Compressed air spray or stationary compressed air supply e Multi purpose grease or similar e Vacuum cleaner e Replacement kit point 2 art no 0001 2501 Room divider 1 Foam cut out 2 Silicone tubes 3 Sylomer ring 4 Standard filter 5 Blower bellows 6 Insert for meander lid 7 Cattflap flow resistor 8 e PC with following system requirements minimum requirements MS Windows 98 2000 NT4 0 ME XP Server 2008 Vista or 7 AMD Athlon Pentium class x86 operating frequency gt 700 MHz min 192 MB RAM for MS Windows 98 NT4 0 ME min 400 MB RAM for MS Windows 2000 XP Server 2008 Vista or 7 min 150 MB available hard disc space or more depending on the desired storage capacity for patient files min 280 MB free hard drive space for the Microsoft NET Framework 2 0 Redistributable x86 2 MB graphics card min High Color 16 bit Mouse 1 free COM interface per device 1 free SD interface only when using DATA box e RS232 adapter cable Sub D9 RJ45 art no 0000 5232 e HOFFRICHTER PC software TRENDset art no 0000 7142 CAUTION All tools measuring equipment and aids possibly exposed to contami
10. e 8 CNECkNG Or extemal damnage sirosti enan a ne eee eee ee een nee eee 8 Checking display and display contrast ccececceceeceeceee eee eee teeta eeeeeeee eee eteeaeen eee eeeeaetneeeeeetaees 8 Borca o 0 0 AEE ETEA ee eee ee EE ee 8 JPN OC EVC eee ee ee ere teen ene eee en eee ee tenner er eee eee ee ee ee 9 allele be aake cae eae EEE re eet ener eet tent eee ene er ener eer er AE ee eer re 13 Assembling TS OS CS ractice ctenatiner ye cp aeasien der aeseeenaiseadeanien aaenanas a FE Or AE EAEI E SEEE 17 CVSS TOSS eena gE ansaid sheer anne AE EE E A EAA 17 F nctiona testing OF ine Oy Soca hice cm ceeecsmeeneesn rea EN EE O rE ETENEE 17 Resetting counters setting date and time s sssssererrrrrsrsrrrrrrrsrsrsrsrsrererersrsrererererenre 17 FS STONING Oe Ge Se or cece AE EE E E ace aeateaecon 17 A CR Wells Gll gd Orc Ecic l c e ene eee ene eee eer ee eee ee eee ee eee 17 B E NOS EE EE EAEE E coin oan E EEEE A E T T 18 DODO SAI anaE A E EEE AEEA E E E EEE 18 SIG SoCs OTA ON oi AE E E E A E crac E A E A TTE 18 PACKA oea e E E E EE E E A E E E E E 18 PO eae a EEE EE NAE EAEE E S EA EAEE ee eee ee ee eee 18 FIGCSSSONSS and wear DANS srnicisesrsr rinkin nE AET EE EA EE EE a 18 Shipping instructions for contaminated medical teChnOlOQ sccsecsscseeeeeeeseeaeeees 19 FFI EEEE E ET A EA ean ce E E E ET 19 Packaging TOF SADONO ca cceetecuanadcausaenaeteewtatnassuncetenweitersanzqenesstesiees vores EEEE EEEn 19 O a a E A E E A A E
11. e RS232 adapter cable to connect the device to your PC Start the TRENDset PC software and open the connected device at Found devices Select the view Times and Counters Reset the filter counter Reset the blower runtime if the blower was changed Reset the date and time if necessary Click on Send a er ee SS i Ql 9 RESTORING DEVICE SETTINGS Select the view Patient Data If necessary enter the patient data using the data backup printout Click on Send to store the settings in the device Select the view Device Settings If necessary enter the patient data using the data backup printout Click on Send to store the settings in the device oY 9 10 CHECKING ELECTRICAL SAFETY The basic point 2 device is equipped with protective insulation and does not have any exposed electrically conductive parts at the housing As such electrical safety testing of the device is not provided for Electrical safety testing is only possible on the power supply unit and is performed by a device safety tester e g SECUTEST SIII which complies with the DIN EN 62353 2008 standard The ref erence point is the ground conductor on the secondary side of the power supply unit external con tact 9 11 FINAL STEPS When all work on the device is done a wipe disinfection of the device s surfaces has to be per formed After completion of the preparation works a final report has to be created Stick a
12. encing pre paration It should be checked whether the dispatch instructions for MRSA contaminated devices see section 7 on page 19 were observed The preparation of MRSA contaminated devices may only be carried out by HOFFRICHTER GmbH or by other companies certified for it Comment In the case of devices used solely for stationary applications the operator must draw up a separate risk assessment depending on the type and level of contamination define the method of prepara tion 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 contamination of a device 3 3 PREPARATION PROCEDURE 1 MANUAL PREPARATION A WARNING The manual procedure must not be used for the preparation of MRSA contaminated devices Hygienic preparation for a patient change may only be carried out by qualified authorized and experienced specialist personnel Manual preparation is described in this hygiene concept 3 4 VALIDATED PREPARATION PROCEDURE 2 KR1000 KEREDUSY A WARNING The KR1000 Keredusy preparation procedure is suitable for the preparation of MRSA con taminated devices Other procedures must not be used Hygienic preparation for a patient change according to the validated KR1000 Keredusy procedure may only be carried out by companies with an accordingly certified quality management system and appropriately qualified authori
13. et PC connection cover 10 Cover plate for DC and PC connection 11 Optional filter system no 12 Top section of housing Gon Fay Fee FOr Fe Bs uum cleaner yes yes yes yes yes yes yes yes yes optional yes optional optional optional optional no yes no optional yes yes yes yes yes Damp cloth Compressed e g mikrozid AF with mild air and vac soapy water uum cleaner 13 Meander lid no yes 14 Air outlet no yes 15 Retaining ring optional yes 16 Fixing elements no yes no 17 Blower bellows no yes 18 Acoustic hood no yes 19 Dampers yes optional 20 Blower bottom section optional yes 21 Blower top section optional yes Note on disinfection All air ducting components must be treated with a disinfectant These components are e Meander lid e Blower bellows e Catflap e Acoustic hood e Air outlet e Filter insert e Blower Carry out disinfection of all components except blower as follows Spray disinfectant on the components Let the disinfectant take effect in accordance with the manufacturer s instructions Remove any surplus disinfectant with a dry dust and lint free cloth oe Let all components air dry completely Carry out disinfection of the blower as follows ATTENTION Do not use disinfectants containing chlorine sensitive to disinfect the blower as chlorine attacks the surface of the housing Step 3 Undo the 5 screws using a Torx Re
14. move the bottom section of the Cover the bearing of the blower screwdriver TX 08 blower to avoid disinfectant entering the blower We recommend applying a little multi grease to the bearing Step 4 Hold the top section of the blower Spray the bottom section of the with the bearing facing downward according to the manufacturer s blower completely with disinfec and spray it completely with disin instructions Place the top section tant and allow it to act according fectant of the blower on a cloth to allow to the manufacturer s instructions the disinfectant to run off Remove any excess disinfectant with a dry dust free cloth Let the components dry com Join the top and bottom sections Screw the top and bottom sec pletely in the air Then remove of the blower together tions together the multi grease from the bearing using a dust free cloth 5 5 ASSEMBLING THE DEVICE After cleaning and disinfection assemble the device as per the section Opening the device but in reverse order Use all the components in the preparation kit 9 6 DEVICE TESTS Carry out the ADU test the excess pressure calibration and the sensor test as per the point 2 Ser vice Manual 5 7 FUNCTIONAL TESTING OF THE KEYS 1 Check for the turbine to switch on and off properly when the ON OFF key is pressed 2 Check whether the menu can be operated properly using the arrow keys 21 fo RESETTING COUNTERS SETTING DATE AND TIME Use th
15. nation must be cleaned after they have been used and treated with disinfectant 5 1 3 UNPACKING AND DISINFECTING CAUTION To protect against germs the surface of the device and where present the humidifier must be treated with a disinfectant immediately after unpacking 5 1 4 CHECKING FOR EXTERNAL DAMAGE Before starting the service check the device and where present the humidifier for external damage 5 2 CHECKING DISPLAY AND DISPLAY CONTRAST Press any key The display lights up with a brightness of 100 Check the display to see whether all characters are shown correctly and completely The background of the display is illuminated the display should be clearly legible in daylight 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 5 If required the display contrast can be re adjusted via PK with the device open see Service manual VY 5 2 1 DATA BACKUP Before starting the service works perform a data backup 1 Connect the device to the mains power using mains cable and power supply unit Use the RS232 adapter cable to connect the device to the PC Start the TRENDset PC software For security reasons make sure you save the device settings File gt Save as Print out the device settings File gt Print and keep the printout for data recovery os E a 5 3 OPENING THE DEVICE Step 1 Step 2
16. wise direction Take the room divider out of the Pull all 4 dampers off the room bottom section of the housing divider Step 19 Step 20 Step 21 Pull the air outlet off the room Pull the air outlet bellows off Lift uo the meander lid as divider the room divider shown in the picture Step 22 Step 23 Step 24 Lift up the meander lid as Remove the insert from the Dispose the room divider and shown in the diagram and take meander lid PE foam and dis the Catflap it off pose thereof Step 25 Step 27 Take the filter insert out of the Moisten the foam in the bottom Using a spatula scrap the bottom section of the housing section of the housing thor foam off the acoustic protec oughly with ethyl alcohol and tion plate before the alcohol allow it to act for around 1 2 dries minutes Step 28 Moisten any adhesive remains Take the new foam cut out Adhere the foam cut out with alcohol and remove these from the preparation kit Peel exactly onto the acoustic pro using the spatula after briefly off the protective film tection plate of the bottom sec allowing the alcohol to act tion of the housing 5 4 CLEANING AND DISINFECTING Damp cloth with mild Compressed air and vac e g mikrozid AF soapy water Battery packs Base rear Bottom section of housing with acoustic pro tection plate Base front Filter insert no Controller circuit board with display no Heating cable Housing fe
17. zed 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 15 4 EXPLODED VIEW DRAWING Membrane keyboard Top section of housing Display Controller cir cuit board Meander lid atl Microphone cover Acoustic hood Fixing element Blower i bellows Retaining ring Fixing element Damper Blower Fixing element Sealing gasket Damper internal for air outlet Room divider Acoustic protection plate Cover plate Air outlet for DC and PC connection Bottom An section of PC connec housing tion cover Base front Filter insert Control panel bas Base rear Cover for humidifier l Adapter for Housing foot Oo muslin Bi uiGiiGr electronics guide foot 5 MANUAL PREPARATION 5 1 PRELIMINARY STEPS 5 1 1 PROTECTIVE AGENTS AND DISINFECTANTS e Hand sanitizer e g Sterillium Bode e Disinfectant spray e g mikrozid AF liquid e Surface disinfectant e g mikrozid AF NOTICE Where possible wipe disinfection is preferable to spray disinfection 5 1 2 TOOLS MEASURING EQUIPMENT AND AIDS e service manual User s manual e point 2 power supply unit with mains cable e Soft work space surface e Different screwdrivers Torx screwdriver TX 08 1
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