Scican Ltd. 1440 Dn Mills Rad, Trnt, Ontari, Canada. M3B 3P9 Prduct Advice Sheet SD-424 HYDRIM Washer Disinfectrs - Recmmended (minimum) Testing Requirements* The HYDRIM range f washer-disinfectrs intended purpse is fr the cleaning and thermal disinfectin f re-usable medical devices, in a single perating cycle. All HYDRIM units have been subject t Type Testing as required by standard EN ISO 15883-1 (Nte: current standard applies) and the relevant subsequent parts specific t the intended purpse f the unit. Wrks (factry) Testing is part f the final inspectin. *All HYDRIM units have been designed t be self mnitring, and shuld cntinue t perfrm n an nging basis in accrdance with the specificatins utlined in the standard; hwever, SciCan recmmends that a regimen f peridic testing is carried ut at specific intervals t ensure the nging perfrmance f the machine cntinues t be as intended. IMPORTANT NOTES: This dcument utlines the minimum requirements t ensure that the equipment perfrms t specificatin. Refer als t the natinal and lcal regulatins and requirements f yur regulatry agency. Please cnsult yur lcal dealer r yur medical authrities fr details. Installatin, cmmissining, repair, annual servicing and re-validatin MUST be undertaken by SciCan apprved technicians. Failure t prperly maintain this equipment may invalidate the results f the fllwing testing regimen. The recmmended peridic testing requirements are as fllws: Cmmissining/Installatin testing Undertaken by - SciCan apprved installatin/service/test engineer. Installatin qualificatin, peratinal and perfrmance tests in accrdance with the relevant HYDRIM Washer Disinfectr Installatin Manual and Preventative Maintenance Schedule dcument included with the unit. User training in accrdance with the abve. Daily tests and checks. Undertaken by - the User. dr lck check 1
wash arm rtatin check (turning and ptential blckage f nzzles) dr seal check lad carrier check check and clean chamber filters (screens) check lad befre releasing lad - visual examinatin (inspectin under magnificatin, when apprpriate) f each lad fr residual sil Weekly tests and checks. Undertaken by - the User. Daily checks, plus: Residual prtein testing SciCan recmmends the Brwne Ninhydrin Prtein Detectin Kit.) Nte: There are a number f cmmercially available tests n the market which may be similar. If these tests are chsen, then we wuld advise the nearest t Ninhydrin equivalence wherever pssible. Mnthly tests and checks. Undertaken by - the User. Daily and weekly checks, and Residual sil testing with surrgate device. SciCan has tested and apprved the fllwing surrgate sil test devices Brwne STF Lad Check system Simicn RI Cleaning Indicatrs SteriTec Wash Check Nte: There are a number f cmmercially available tests n the market which may be similar but have nt been tested by SciCan. If these tests are chsen, then we wuld advise that yu cnsult with yur HYDRIM dealer r lcal authrity t establish suitability prir t use. (See Annex A f this dcument fr advice n using the surrgate device in yur HYDRIM WD) Annual tests, checks and re-validatin. Undertaken by - SciCan apprved installatin/service/test engineer. IMPORTANT NOTE A full annual service shuld be undertaken befre re-validatin in accrdance with relevant HYDRIM Washer Disinfectr Installatin Manual and Preventative Maintenance Schedule dcument included with the unit. Re-validatin testing will include, Autmatic cntrl test/ Full cycle prfile thermmetric check f time and temperature, (see annex B f this dcument) Chemical dsing test, where apprpriate (see Annex C f this dcument) 2
Cleaning Efficacy Test revalidatin test with apprpriate test sil. (See annex D f this dcument) Ninhydrin Residual Prtein Test. (See annex E f this dcument) Lad Dryness Test. (See annex F f this dcument) 3
Annex A The use f cleaning efficacy test surrgate devices in HYDRIM washer disinfectrs This test is designed t demnstrate the satisfactry perfrmance f the abilities f the machine t remve grss sil frm cntaminated instruments. All HYDRIM units have been subject t Type Testing and Wrks (factry) Testing as required by standard EN ISO 15883-1 (Nte: current standard applies). This includes the use f a wide range f cmmercially available surrgate devices fr use by the user f the washer-disinfectr (WD) which emulate the remval f grss sil frm medical devices. (Nte that sme may als emulate the remval f prteins). Althugh in general terms all these devices are designed t wrk in the same way, they may vary in type and brand depending n the regin/cuntry where the WD is lcated. SciCan has tested a number f devices (listed in the test schedule abve). Other devices may be used but shuld cnfrm t the requirements belw. Test device requirements. All HYDRIM units have been designed t cmply with the requirements f EN ISO 15883. Part 5 f this standard specifies a number f test sils which are used in varius cuntries fr replicating the likely cntaminants that may be depsited n surgical devices when used in surgical prcedures. When selecting a surrgate (user) test it is recmmended that the test is ne that replicates wherever pssible the test sil in the regin where the WD is lcated. Test availability. These tests shuld be readily available frm many lcal steriliser and WD supply huses. If ne cannt be fund in yur regin, please cntact the dealer wh supplied yur HYDRIM unit. Using the device. Fllw the manufacturer s instructins with regard t lading the wash efficacy indicatr int any hlding device, place the device in an pen basket near the centre f the lad carrier and surrund the device with a nrmal (typical) lad. D nt cver the device with the remainder f the lad. Run a P2 Regular Wash cycle unless specified by the device manufacturer. 4
Typical test device placement illustratins Ntes: Lads shwn are fr reference nly Lad furniture may vary frm that shwn Brwne STF Lad Check system used in these illustratins fr visual reference nly Pass/Fail criteria. These criteria shuld be specified by the manufacturer f the device. (Nrmal pass criteria is a test strip clean f any simulated sil) Please nte: Indicatrs that have been expsed t ambient air fr an extended perid f time may have dried-n test sil and may prduce a false negative (fail) test result. Ideally, nce a package has been pened, indicatrs shuld be stred in a re-sealable plastic bag. 5
Annex B Autmatic Cntrl Test/Full Cycle Prfile thermmetric check. General This test is designed t demnstrate that the perating cycle functins crrectly and the values f the cycle variables indicated by the WD and recrded by any instruments fitted t the WD, cmpare t values btained frm independent recrding devices calibrated t Natinal r Internatinal standards and the riginal specificatin f the unit. The temperature sensr(s) fr thermmetric testing (depending n test equipment used) shall be cnnected t the chamber during this test. One sensr MUST be placed adjacent t the cntrl/validatin sensr in the unit s that if apprpriate, the calibratin may be checked during perids f stable temperature. Equipment Requirements Minimum requirements calibrated independent temperature reference device (digital thermmeter) with at least 1 (ne) matched thermcuple. Recmmended requirements - calibrated independent temperature/time reference device (data lgger) with at least 3 (three) matched thermcuples r RFID wireless recrding devices. Prcedure Attach the independent reference device t the unit as apprpriate. A thermcuple entry prt is prvided n all HYDRIM units t enable thermcuples t be inserted int the chamber withut the need t cmprmise the dr seal. The tp panel f the machine must be remved t access the prt. Depending n the test equipment being used (see abve) the thermcuples/lggers shuld be lcated in pririty rder thrughut the machine. If using the minimum single thermcuple this MUST be lcated adjacent t the cntrl/validatin duplex thermcuple, lcated in the sump under the carse filter. If using 3 thermcuples/lggers, ne must be placed as abve and tw in the lad. It is recmmended that the tw lad thermcuples/lggers are placed diagnally ppsed t each ther in the crner f the lad. This represents the cldest parts f the lad. If mre than 3 thermcuples/lggers are being used then the preferred lcatins in rder f pririty shuld be as fllws: Lad extremities. Lad centres. Chamber crners* Chamber walls* * Nte: this is nly apprpriate where thermcuples/lggers can be fixed t vertical surfaces. 6
Place the test lad apprpriate t the mdel f WD in the lad carrier(s) nrmally used by the peratr. Nte: Ideally the lad requirements shuld be specified and dcumented by the user f the device and a pre-defined wrst case lad f actual instruments apprpriate t the intended purpse f the unit and its accessries shuld be agreed upn prir t testing. (Ntes n recmmended lad types can be fund in Annex G f this dcument.) Hwever, if this is nt pssible, the lad shall cnsist f a mass f stainless steel blts evenly distributed, in wire baskets, thrughut the usable chamber space t the recmmended quantity cnsidered by SciCan t be representative t the chamber size f the unit being tested*. The blts shuld be austenitic stainless steel grade, M12 x 100 mm lng with hexagn heads. They shuld be cleaned, degreased and dried befre use. * Recmmended lad is 24 blts fr 50/60 litre units (single level lad carrier) and 48 blts fr 110 litre units (duble level lad carrier). Example f blt lading in 110 litre unit (duble level lad carrier shwn). Clse the dr f the unit. Ensure there is sufficient prcess chemical t cmplete the test. Where multiple cycles are displayed n the WD screen, select the perating cycle t be tested based n the cycle which is used in nrmal peratin. Fr validating thermal disinfectin, the apprpriate disinfectin prgram MUST be selected. Start the apprpriate cycle. If the WD des nt have a recrding device (e.g. printer), and/r the reference device des nt have data recrding capabilities, (e.g. simple digital thermmeter) bserve 7
and nte manually the elapsed time, indicated chamber temperature(s) frm the machine display and the indicated chamber temperature(s) frm the reference device display at all significant pints f the perating cycle, fr example the beginning and ending f each stage r sub-stage, and the maximum values during the hlding time. Recrd any manual readings. Where recrding devices and data lgging devices are being used, printuts/displays f the cycle will be required fr analysis n cmpletin f the cycle. Results The test shall be cnsidered satisfactry if the fllwing characteristics are bserved: During the whle f the peratinal cycle all the recrded values f the cycle variables are within the maximum and minimum prcess limits specified fr the relevant HYDRIM unit. At significant pints in the cycle, the reading frm the WD display, reference device display (r plt if using a data lgger) and recrding device (if fitted) are within ± 2ºC at their cmparative time intervals. The time fr which the disinfectin temperature was maintained was nt less than the specified time fr the cycle being tested. The dr(s) cannt be pened until the cycle is cmplete The persn cnducting the test des nt bserve any mechanical r ther anmaly. As all HYDRIM WD units are micrprcessr cntrlled and self validating this test shuld nly need t be cnducted nce per re-validatin. In the event f the unit failing t reprduce the results abve, and nly after crrective actin is taken t restre the unit t factry specificatins, further tests shuld be cnducted three times t ensure cnsistent results. In this event, it shuld be nted that the variatin in temperature at the same pints in the three test cycles shuld differ by n mre than 4ºC Ntes: On HYDRIM G4 type units, the factry (wrks) test cycles will be recrded n the unit s internal memry card (which may be referenced n the wrks test certificate) and may be used as a basis fr cmparisn during revalidatin if apprpriate. These cycles will generally be the first cycles recrded by the unit and may be retrieved in a number f ways (fr cycle master reference purpses) if required: When the USB device is first inserted int the data lgger during installatin, any cycle data stred n the internal memry card shuld be autmatically dwnladed (ONCE ONLY) t the USB device. These cycles MAY either still be n the USB device r it may have been transferred t the custmer s strage media (cmputer etc). The entire archive can be cpied nt a new USB via the fllwing buttn sequence: 8
NOTE: Depending n hw many files are stred n the memry card, this culd take a cuple f hurs If the HYDRIM G4 unit is cnnected t a lcal area netwrk, cycle data may be retrieved frm the unit s web prtal archive thrugh any cmputer r smart device cnnected t the same netwrk. If the HYDRIM unit is nt cnnected t a lcal area netwrk, a hard wired cnnectin via ethernet cable directly t a laptp can als be used t access the unit s web prtal archive. 9
Annex C Chemical dsing test General The HYDRIM detergent dsing system cnsists f either (i) a peristaltic pump plus flw switch (nn G4 units) r (ii) a bellws pump (G4 units). Fr prper peratin, the pump flw has t be adjusted/ checked at initial factry setup and at regular maintenance intervals. Nte that this test can nly be perfrmed n certain Hydrim derivatives as listed belw: Unit type Test available Ntes HYDRIM C51wd N HYDRIM M2 sftware lwer than R320 N See M2 service manual HYDRIM M2 sftware R320 r higher Yes HYDRIM C61wd G4 Yes HYDRIM M2 G4 Yes Prcedure fr M2 (nn G4) units (sftware R320 r higher) Fr this peratin a small bttle (arund 40ml) and a measuring tube (minimum 40ml) are required. T start the prcedure, g t the Dsing Pump Setup screen lcated in the Technician menu under the sub menu Diagnstic Tls (2), Ensure that there is sufficient prcess chemical available in the unit t perfrm this test. 10
Befre pressing the Start buttn please read the fllwing instructins: By pressing the Start buttn the dsing pump is activated and the message WAIT is displayed. When the flw switch turns ON (Flw Sw = 1) the dsing pump will run fr an additinal 10 secnds and the message DONE is displayed shrtly afterwards. Run this sequence nce t ensure that the internal dsing system is primed (flw switch, internal tubing). Once this is cmpleted, prepare t cllect the detergent delivered t the washing chamber with the small bttle, see picture belw, and press the START buttn. The dsing pump will activate again fr 10 secnds (assuming that the flw switch is primed with detergent as specified abve). When the detergent delivery ends, transfer the liquid cllected frm the small bttle int the measuring tube and read the vlume = D [ml]. Nw multiply vlume D by 6 t find the Dsing Pump Flw (DPF) in ml/min. Fr example fr D = 35ml => Dsing Pump Flw = 35 x 6 = 210 ml/min The DPF/min value shuld be as fllws: Unit type DPF range HYDRIM M2 sftware R320 r higher 190-242 If the number is utside f these values, exit the Dsing Pump Setup and check that the dsing pump is running crrectly, repeat the prcedure abve, and if the DPF value is still utside f the specified range, replace dsing tubing and/r pump. 11
When the DPF value is acceptable, use Up r Dwn arrw t change DPF/min value t the new calculated value. Exit the Dsing Pump Setup screen by pressing the left arrw. This ends the Dsing Pump Flw check/adjustment prcess. As all HYDRIM WD units are micrprcessr cntrlled and self validating this test shuld nly need t be cnducted nce per re-validatin. In the event f the unit failing t reprduce the results abve, and nly after crrective actin is taken t restre the unit t factry specificatins, further tests shuld be cnducted three times t ensure cnsistent results. In this event, the vlumes f the dispensed liquids during each f the 3 tests shuld be within ± 5% by vlume. Test Acceptance criteria. The DPF value is within the acceptable range. Prcedure fr C61wd G4 and M2 G4 units This prcedure requires the fllwing items: 1x Dsing Pump Test Adapter (01-113909S) 1x 100mL Graduated Cylinder Turn unit ON and g t Technician menu. G t Dsing System Screen lcated in Technician Menu / Diagnstic Tls /Cmpnent Test. Fr M2 G4: Remve upper trlley frm the unit. Fr C61wd: Remve trlley frm the unit. Insert dsing pump test adapter n the pening f the chamber intake fitting. If necessary hld in place with light pressure (Figure 1). Press ON buttn n display t start bellws dsing pump. Cllect the chemical cming ut frm the chamber intake fitting int a graduated cylinder. A cuntdwn will appear n screen t indicate prgress. (Figure 2) Press OFF buttn n display after the cuntdwn is finished. The dsing valve (M2 G4) r dsing fill pump (C61wd G4) will activate t refill the dsing reservirs as indicated by a buzzing nise. Any further testing shuld nt be undertaken while this prcess is taking place. Read the chemical vlume inside the cylinder. The vlume cllected shuld be: 12
Unit type HYDRIM C61wd G4 HYDRIM M2 G4 Chemical vlume 41.0 45.4 ml 91.2 100.8 ml If the chemical vlume is utside these ranges, check all the tubing fr prper cnnectins and kinking. Repeat the test. Replace bellws dsing pump if value is still utside the range. Empty the cylinder and repeat abve prcedure. The chemical vlume shuld be within the same range. In the event f the unit failing t prduce the results abve, and nly after crrective actin is taken t restre the unit t factry specificatins, further tests shuld be cnducted three times t ensure cnsistent results. Figure 1: Dsing Pump Test Setup Figure 2: Screen Display 13
Annex D Cleaning Efficacy testing. General This test is designed t demnstrate the satisfactry perfrmance f the abilities f the machine t remve grss sil frm cntaminated instruments. Fr this test, an apprved test sil shuld be used which shuld be based n the applicable reginal annex f EN ISO 15883-5 (latest editin applies). Nte that there are a number f apprved test sils which are specified fr different regins and it is recmmended that the apprpriate test sil is used fr this test. IMPORTANT NOTE: The test sils recmmended in EN ISO 15883-5 are labratry prepared. Hwever, in many regins, a dehydrated test sil (with Natinal standards equivalence) may be available and is recmmended n the basis that it has a much lnger shelf life than labratry prduced bld based prducts. If in dubt, please call the dealer wh supplied the unit fr advice and guidance. Equipment requirements, prcedure fr testing and interpretatin f results. This will vary depending n the test sil being used. Reference shuld be made t EN ISO 15883-5 fr the methd, equipment and results apprpriate t the chsen test sil. Nte: If the unit yu are testing des NOT have a separate wash TEST cycle, then the perating cycle chsen must be stpped befre the final rinse prtin. i.e. the cycle shuld cnsist f Pre-wash, Wash and Intermediate rinse(s) (if apprpriate) nly. All standard cycles n each HYDRIM unit derivative will have the same Pre-wash, Wash and Intermediate rinse parameters s any f the wash cycles can be selected fr this test (P2 Regular Wash, P3 Heavy Duty Wash & Disinfect r P4 Custm, when apprpriate). If in dubt, please call the dealer wh supplied the unit fr advice and guidance. Test lads. Select the test lad apprpriate t the type f WD in the lad carrier(s) nrmally used by the peratr. Nte: Ideally the lad requirements shuld be specified by the user f the device and a pre-defined wrst case lad f actual instruments apprpriate t the intended purpse f the unit and its accessries shuld be agreed upn prir t testing. (Ntes n recmmended lad types can be fund in Annex G f this dcument.) 14
Hwever, if this is nt pssible, the lad shall cnsist f a mass f stainless steel blts evenly distributed, in wire baskets, thrughut the usable chamber space t the recmmended quantity cnsidered by Scican t be representative t the chamber size f the unit being tested*. The blts shuld be austenitic stainless steel grade, M12 x 100 mm lng with hexagn heads. They shuld be cleaned, degreased and dried befre use. * Recmmended lad is 24 blts fr 50/60 litre units (single level lad carrier) and 48 blts fr 110 litre units (duble level lad carrier). Prcedure Select 12 (twelve) items f the lad t be cntaminated. If actual instruments are being used, then select 3 (three) f 4 (fur) types that are cnsidered t be the biggest challenge t the machine. Using prtective glves, prepare labratry r dehydrated test sil in accrdance with the manufacturers instructins. Sufficient sil shuld be prepared t fully cat the 12 (twelve) selected items. Place test sil in tray. Apply the sil t the test pieces by fully immersing slid items in the sil r, fr larger and hllw items, apply an even cat f sil using the paint brush. Allw excess sil t drain frm the items and allw them t dry at rm temperature (15 C t 25 C) fr nt less than 30 min and nt mre than 2 h. Fully lad the WD with the chsen lad and evenly distribute the inculated lad items in the lad ensuring that sme are n the extremities f the carriers. Run a nrmal perating cycle (r wash test cycle if available). At the apprpriate pint in the cycle, stp the unit and remve the lad items frm the WD and subject them t careful visual examinatin fr residual sil. Fr the cleaning prcess t be regarded as satisfactry there shall be n visible residual sil present n the lad. NOTE: This test needs t be satisfactry befre any residual prtein testing is undertaken. 15
Annex E Ninhydrin test fr residual prtein. General Much f the cntaminatin which ccurs n reusable medical devices is, in whle r part, prteinaceus in nature. The methd described belw prvides a pass/fail test with a high level f sensitivity fr prteins and amin acids. Fr this test the Brwne Ninhydrin Prtein Detectin Kit is recmmended as it is cmpatible with the requirements f EN ISO 15883-1 (Nte: current standard applies) Instruments (r surrgate items) used in this test shuld be nes that have been recently prcessed in the WD and knwn t be visibly clean (see Annex D). Equipment and materials requirements. Cttn swabs (with plastic handles) 2 % ninhydrin in 70 % isprpanl Sterile distilled water Oven (110 C) Prcedure Misten the swab with sterile distilled water and use it t swab the surface f the instrument(s) t be tested. Ensure that the area t be swabbed is nt less than 5 cm 2 and nt mre than 50 cm 2. After swabbing the instrument, examine the swab. Any discluratin indicates that the instrument was nt clean and there is n need t prceed further at this pint. If acceptable, place a drp (apprximately 0.05 ml) f the ninhydrin reagent n the swab and allw t air dry fr apprximately 5 min. If a purple clratin develps, residual prtein/amin acids have been detected and n further actin is needed at this pint. If n clur has develped, transfer the swab t the ven and heat at 100 C t 110 C fr 30 min and re-examine the swab fr purple cluratin. Run a psitive and negative cntrl fr each series f tests carried ut. Acceptance criteria There shall be n disclratin f the swab prir t the applicatin f the ninhydrin reagent. There shall be n visible purple disclratin f the swab after applicatin f the ninhydrin reagent befre r after heating at 100-110 C fr 30 mins in ven. 16
Annex F Lad Dryness Test. General The fllwing test shall be carried ut when the perating cycle includes a drying stage. This test may be undertaken as an extensin f the Autmatic cntrl/full cycle prfile thermmetric check if the cycle selected has a drying cycle fllwing n frm thermal disinfectin. Data recrded during the drying phase shuld be ignred fr the purpses f the thermmetric tests. Equipment and materials requirements. Clured (e.g. blue r green) crepe paper. Prcedure If this test is nt an extensin f the thermmetric full cycle prfile test then prceed as fllws: Select the test lad apprpriate t the type f WD in the lad carrier(s) nrmally used by the peratr. Nte: Ideally the lad requirements shuld be specified by the user f the device and a pre-defined wrst case lad f actual instruments apprpriate t the intended purpse f the unit and its accessries shuld be agreed upn prir t testing. (Ntes n recmmended lad types can be fund in Annex G f this dcument.) Hwever, if this is nt pssible, the lad shall cnsist f a mass f stainless steel blts evenly distributed, in wire baskets, thrughut the usable chamber space t the recmmended quantity cnsidered by Scican t be representative t the chamber size f the unit being tested*. The blts shuld be austenitic stainless steel grade, M12 x 100 mm lng with hexagn heads. They shuld be cleaned, degreased and dried befre use. * Recmmended lad is 24 blts fr 50/60 litre units (single level lad carrier) and 48 blts fr 110 litre units (duble level lad carrier). Carry ut a nrmal perating cycle frm a cld start, i.e. the WD shall nt have been used within the previus hur. Within 5 min f the end f the perating cycle, place a sheet f clured (e.g. blue r green) crepe paper n a flat surface and place the lad n it. When remving the lad frm the WD, and as the individual lad items are placed nt the crepe paper, bserve and recrd any water being discharged. Examine the crepe paper fr dampness shwn by dark spts n the paper which shall be regarded as evidence f residual water. 17
Items with lumens shuld als be visually examined fr internal retained misture. Results Reprt whether r nt any residual water was fund. If water was fund, pssible causes culd be: Blcking f the exhaust Frnt f the unit must be clear Duct inside the chamber must be clear HEPA Filter has been exhausted Malfunctining blwer Refer t the service manual fr instructins n servicing/replacing parts. 18
Annex G Recmmended lad cnfiguratins. General cnsideratins when chsing a lad fr validating HYDRIM units: There are varius different lads that can be used t validate HYDRIM WD units bth fr cleaning efficacy testing and thermmetric testing f the thermal disinfectin cycle. It is imprtant when cnsidering a validatin lad t familiarize yurself with any lcal, natinal r internatinal guidelines that may take precedence when validating. If there are n specific verriding guidelines in frce, SciCan recmmends using ne f the fllwing: 1. Select a validatin lad using the lad carrier(s) and instruments nrmally used by the peratr. The lad requirements shuld be specified and dcumented by the user f the device and a pre-defined wrst case lad f actual instruments apprpriate t the intended purpse f the unit and its accessries shuld be agreed upn prir t testing. 2. Use a surrgate lad, again using the lad carrier(s) nrmally used by the peratr. A typical surrgate lad can cnsist f a mass f stainless steel blts evenly distributed thrughut the lading space t the maximum mass specified fr the WD. The blts shuld be austenitic stainless steel grade, M12 x 100 mm lng with hexagn heads. They shuld be cleaned, degreased and dried befre use. 3. A test lad in accrdance with the natinal requirement listed in the apprpriate annex f EN ISO 15883-5 (Nte: current standard applies). 4. A lad in accrdance with SciCan type test lads. Ntes: In sme cases, specified lads in the varius sectins f 3 abve may be fixed and nt truly reflect the use f the WD being validated. SciCan type test lads are als very specific and are designed t cmply with the requirements f EN ISO 15883-5 (Nte: current standard applies) and als the wrst case scenari lads. Fr this reasn, SciCan recmmends wherever pssible t use lading as in 1 r 2 abve as they are likely t be mre representative f typical general user requirements. The specific tests in this dcument reflect this advice. General lad infrmatin. The intended purpse f the HYDRIM range f washer disinfectrs is as a general instrument thermal WD, predminantly aimed at the general dental market. There will therefre be many cmbinatins f instruments that can be prcessed in the HYDRIM unit depending n: Size f practice Types f prcedures undertaken at any ne time Specialisatin f practice Instrument management prtcls 19
It is difficult therefre t shw all the pssible cmbinatins available, s belw we have given examples f the mst cmmn typical basket ladings, the recmmended lading f general instruments, and the wrst case lading the unit has been type tested and validated fr. Basket lading: (Nte: Baskets shwn are typical fr illustratin purpses nly and may vary dimensinally depending n unit size/derivative.) 20
Example 3 hinged instruments, slid instruments and pen hllw instruments 21
Validated lad cnfiguratins - Type Test Lads: As part f the requirements f EN ISO 15883 all HYDRIM units have been type tested fr cleaning efficacy and thermal disinfectin. The lad cnfiguratins used fr validating the machine were the recmmended standard ptimal lading fr instruments nt in cntainers and the recmmended maximum instrument lading instruments and cassettes as discussed abve. All HYDRIM units are validated in the factry using the fllwing cnfiguratins (instruments where shwn are fr visual reference nly and d nt represent actual type test lads): 1. Recmmended standard ptimal lading fr instruments nt in cntainers (cassettes). Fr a full lad f general surgical instruments the recmmended basket cnfiguratin is: 50/60 litre single level units 2 x 01-107241 STATIM 5000 Baskets 110 litre duble level units 4 x 01-108232 Lng Basket 22
2. Recmmended maximum instrument lading - instruments in cassettes. Fr a full lad f general surgical instruments cntained in cassettes the recmmended cnfiguratin is: 50/60 litre single level units C51wd mdels C61wd G4 mdels C51wd - 1 x 01-109153 4 cassette rack + 4 x SYS-TM4B instrument cassettes. C61wd G4-1 x 01-113251 6 cassette rack + 6 x SYS-TM4B instrument cassettes. 110 litre duble level units (all mdels) Tp 1 x 01-109963S Cassette rack, full size + 5 x SYS-TM4B instrument cassettes. Bttm 1 x 01-109963S Cassette rack, full size + 5 x SYS-TM4B instrument cassettes. 23