OOOmA XMSh <> will give the same action. 2, The LCD will display the current calibration value. The left value is HGB calibration value and the right HCT calibration value. 3. ‘The HGB calibration value which is on the cursor can be changed. Input anew setting value with numeric keys and press to set the new calibration value into the instrument. If change of the HGB calibration value is not necessary, press without pressing numeric keys. Then the cursor will move to the HCT calibration value. ‘Set the HCT calibration value in the same way. 4. After setting of HCT calibration value by pressing 119.8% HCT : 104.0% ~ 105.0% NOTE HGB AND HCT FACTORS CAN BE CHANGED WITH STEPS OF MAXIMUM 5%, IF A HIGHER CALIBRATION IS REQUIRED, THIS CAN BE DONE WITH SOME STEPS. Example : HGB : 100.0% TO 108.0% First enter the value 104.0% and then the second time 108.0% (2-times 4%) A calibration of >5% at once will be ignored 5. Ifil's necessary to calibrate the other parameters: WBC, RBC and PLT. Press first <9> <.> <0> and then press <8> , 6. Press key <2> or <> until C.O.C. appears in the LCD. Press . DO NOT change the calibration values with suffix (C) or P)8. With the option <8> menu you can print out all calibration data. Example: CALIBRATION DATA wec 85.6% RBC 104.5% PLT 96.0% wee 127.7% — (P) RBC 100.4% — (P) PLT 108.0% — (P) HGB 100.1% — (P) wcv 99.8% — (P) WBC 97.0% (C) RBC 105.8% — (C) PLT 114.6% — (C) HGB 79.3% — (C) cv 94.3% — (C) 18PRIMING Priming of the Mallinckrodt Baker reagents as described in this protocol is necessary, because the K1000 has internal reagent reservoirs. When priming is not complete, contamination of Mallinckrodt Baker reagents with Toa reagents will occur. The priming protocol as described below must be to carry out a successful priming! Priming of 1000: of K1001 ‘Switch ON the power of the Toa K1000 instrument and the compressor with the POWER SWITCH. An AUTO RINSE procedure will be carried out. 2. Go on with step 3 when the background values are within to the following specifications: WeC s 03x 10% RBC < 0.02 x 1012/1 Hb< 0.1 mmollt PLT < 10 x 10% 3. Remove the aspirating tubes from the Toa Reagent cubitainers and clean the outside surface of these tubes thoroughly by rinsing them with distilled or de-ionised water. After rinsing put the aspirating tubes in a clean and empty beaker. 4, To remove the Toa Reagents from the K1000, PROGRAM SWITCH SW 3 must be changed. Press <7> on the keyboard. Select PROGRAM SWITCH by pressing 3 times the key <2>. The message PROGRAM SWITCH will appear in the display. Then press . 5. Press two times the key to activate the PROGRAM SWITCH SW 3 is activated. PROGRAM SWITCH SW 3 consists of the following functions: Bit No. Function 8 Not in use 76 (Service Purpose only) NOTE: normally these bits should be in the "0" position 54 Select the date format. BitS4 — = 00° (yymmidd) 01 (mmidayy) 10° (dd/nm/yy) 44 (yy/mmidd) 324 Select the units Bit321 = 000 (Japanese) 0.01 (General export units) 010 (Standard S!) 0.14 (Dutch SI) 0 (Canadian Sl) 1 (Hongkong S!) 0 (Japanese) 1 ° 0 1 11 (Japanese) 1 1 1 1 19Example: bits: 8 6 0 Zz 4737274 ‘switch_[ 1 | 0 5 tpofotiti 6. Switch bit 7 in the "1" position by pressing first key <6> and then key <8>. Repeat this handling to switch bit 6 in the "1" position. Press two times to confirm the settings in the PROGRAM SWITCH SW 3, 7. Tum off the Toa K1000 instrument with the POWER SWITCH. The POWER SWITCH of the compressor unit must be kept in the switch on position. 8. Turn on the Toa K1000 instrument with the POWER SWITCH. The WBC, HGB and Diluent Reagent Chamber and all tubes with Reagent will be emptied. After this action the Toa K1000 will automatically perform an AUTORINSE procedure. When the following error message appears on the printout: NO DILUENT REPLENISH & PRESS 1. Put first the aspirating tube of the diluent into the Diluid 100 plus cubitainer and then press key <1> to continue. If the error message appears again press key <1> to solve this error. The Mallinckrodt Baker diluent is now introduced in the Toa K1000 instrument. WARNING : DO NOT SWITCH OFF the K1000 instrument. 9. Repeat step 4 to 7 and then go on with step 10. TI HGB Reagent Chamber completely. is necessary to empty the WBC, WARNING : CONVINCE YOURSELVES THAT THE INTERNAL REAGENT RESERVOIRS OF THE HGB AND WBC REAGENT ARE COMPLETELY EMPTY. You can see it visually by taking of the front cover and look into the reservoirs. If there is still some reagent in the reservoirs, repeat step 4 to 7 again, until the reservoirs are completely emptied. 10. The Toa Reagents are removed from the K1000. The Mallinckrodt Baker Lytic Reagent CyMet 1000 must be introduced. Connect the aspirating lube of the WBC Reagent and HGB Reagent with the Y-joint as showed in the picture below. One of the aspirating tube is now redundant and will not be used anymore. It’s also possible to connect CyMet 1000 cubitainers to the WBC and HGB aspiration tube, without using the Y-joint. aspirating tube aspirating tube of HGB REAGENT of WBC REAGENT \ f CyMet 1000 11. Pul the combined aspirating tube into the cubitainer of CyMet 1000. 20412, Perform an AUTO RINSE by pressing the keys <4> . If there is a CAP PIERCING UNIT on the Toa K1000 you must press key <1> after these commands for the OPEN MODE or key <2> for the CLOSED MODE. 13. Within a few minutes the following error message appears on the printout: NO HGB REAGENT REPLENISH & PRESS 1. Press key <1> and the CyMet 1000 will be aspirated in the Toa K1000 and the HGB buffer chamber will be filled. If the error message appears again press key <1> to solve this error. 14, The next error message on the printout will be: NO WBC REAGENT REPLENISH & PRESS 1 Press key <1> and the CyMet 1000 will be aspirated in the Toa K1000 and the WBC buffer chamber will be filled. If the error message appears again press key <1> to solve this error, The AUTO RINSE procedure will be completed. 15. Perform another AUTO RINSE procedure by pressing the keys <4> and check if the background values are within the specifications as mentioned in point 2 of this protocol. When the background values are too high perform another AUTO RINSE procedure. Note 4 : After priming the background value of WBC may be increased. This is mainly due to air bubbles in the system. in this case, perform the next handling: + Press <6> BAR to perform a blank count. = Repeat this a few times. The blank counts will slowly drop to acceptable values. = If high background values stil remain, turn the power off and wait for 30 minutes. Turn the power on and the K1000 will run an AUTO RINSE procedure. Note: When changing from Cyanide to Cyanide free reagents a recalibration for the Hb is required, 16. All Mallinckrodt Baker Reagents are now introduced in the Toa K1000. Check the priming by analysing five times one EDTA blood sample. if the WBC and Hb values remain constant the priming was successful. If these values aren't constant, perform another AUTO RINSE. 24MAINTENANCE SYSMEX K-1000 "FIGURE 1 Maintenance of the Sysmex K-1000 consists of two levels: - User maintenance done by the operator - Technical maintenance done by the service engineer Maintenance of the Sysmex K-1000 must be done in a fixed time period: - Daily - Weekly - Monthly - Quarterly + Half-yearly > Yearly User maintenance consists of a few controls en the cleaning of the instrument. This must be done during the daily-, weekly- and monthly maintenance. Technical maintenance consists of adjustments and preventive maintenance. This must be done during Quarterly-, half-yearly- and yearly maintenance. On the next pages stands a few parts of the Sysmex K-1000 and is written how maintenance must be done. during user maintenance any defects are found, the service engineer must be informed directly. 22Parts of Sysmex K-1000 Front view FIGURE 2 4, Cap piercing unit 5. printer 2. Aspiration pipette 6. LCD display 3. Tray 7, Power switch 4. Control panel Rear view Loft side view FIGURE 3 1, Pneumatic power outlet 6. 0.5 kg/cm? pressure gauge 2. Fuses 7. 250 mmHg vacuum cauge 3. Power inlet 8. Bellows unit 4, Connector J1 (printer card) 9. Inletioutlet nipples 5. Connector J2 (computer) 10. 0.5 kg/cm’ pressure regulator 23® USER MAINTENANCE Perform user maintenance on the Sysmex K-1000 as follows’ MAINTENANCE, WEEK CLEAN AFTER USE PERFORM AUTO RINSE CYCLE WATER LEVEL CHECKING AND DRAINING PNEUMATIC UNIT TRAP CHAMBER. DRAINING DRAIN FILTER ASSEMBLY CLEANING SAMPLE ROTOR VALVE CLEAN RBC AND WBC TRANSDUCERCHAMBERS CLEANING THE WASTE. CHAMBER AND TRAP CHAMBER: CLEANING THE RINSING CUP CLEANING THE HGB FLOWCELL | CHECKING THE INSTRUMENT LON DAMAGES ‘Set your initial after maintenance on the User maintenance schedule. 24DAILY MAINTENANCE Daily maintenance on the Sysmex K-1000 consists of: = Cleaning after use = Performing an AUTORINSE cycle - Draining drain fitter assembly = Water level checking and draining pneumatic unit trap chamber 4. Cleaning after use: Aspirate, after use of the K-1000, the instrument twice with hypochloryte. Verify the background data’ WBC <0.3 x 10%iL RBC < 0.02 x 10%L HGB<0.1 — g/dt PLT <10) x 10%L Ifthe results are NOT good, aspirate once again with hypochloryte. Verify the results again. Are they still NOT good, inform the service engineer. Check if there are any blood ‘spots on the instrument. If so, clean the instrument, 2, Perform a AUTORINSE procedure: © Press [SELECT] [C] [4] [ENTER]: AUTORINSE. * Choose: a. [1] CLOSE: Cap piercing rinse or, b. [2] OPEN: Open mode rinse. + The Sysmex K-1000 performs automatic rinsing which is the same procedure performed immediately after power-on. After 3 cycles of Auto Rinses, background check is performed. if the background is not OK, another two rinse cycles are conducted. If the background count still not good, the built-in printer will print an error message: "BACKGROUND ERROR’. Perform step 2 again when this happens. * If the values of the background count still out of limits, inform the service engineer. 3. Draining of the drain filter assembly: After the day's analyses or at least every 24 hours, the filter assembly must be drained, Note that the amount of water that precipitates in the Drain Trap Fiter (5) varies with the moisture contained in the air of the environment in which the system is set up. ‘+ Pull the front cover forward open, while the power is on. + Check the level of water in the drain trap filter on the left front of the Main Unit. + If there is water, push up the knob (4) as shown in figure 4 to drain the water out into a waste container through a silicone tube. 4 = prossure gauge ressure regulator acum gauge 4= vacuum regulator (blows unit) 254. Water level checking and draining pneumatic unit trap filter: Alter the day's analyses, check the level in the trap chamber on the pneumatic unit, If there is water in the trap chamber, discard the water, + Tum off the power of the Main Unit. Allow about one minute to release pressure. + Check the water level in the trap chamber on the left of low of the front of the. pneumatic unit, ‘+ If there is any water, hold the chamber as shown in figure 5 and turn it counterclockwise and discard the water. Do not lose the ball float. Re-tighten the camber. FIGURE 5 1 pressure gauge 4= trap chamber 2= pressure regulator 5 = onloff knob 3= vacuum gauge CAUTION If water is found to be present in the trap chamber on a daily basis, it may be suspected that the Main Unit is malfunctioning, If such is the case, inform the service engineer. Reference: Sysmex K-1000 Operator's Manual 26WEEKLY MAINTENANCE Weekly maintenance on the Sysmex K-1000 consists of: = Cleaning the Sample Rotor Vaive (SRV) - Cleaning the WBC and RBC transducer chambers + Daily maintenance 1. Clean the Sample Rotor Valve as follows: * Turn off the power of the Main Unit. Wait for the pressure to release (about 1 minute). * Pull the front cover forward to open. ‘+ Loosen the two screws of the cap piercer unit. * Loosen the two screws of the display module, and open the module by pulling it towards, to get more space + Place tissues beneath the SRV to prevent the instrument of damage because of any leakage. + Turn the pressure fixing screw counterclockwise and remove it from the shaft on which the SRV fit + Remove the SRV carefully, The three valves fit together tightly and are not easily ‘separated; pull them slightly out downward, and gently twist off one by one, ‘+ Clean the three valves with hypochioryte. + Clean them with alcohol + Rinse the valves with distilled water. * Place the SRV back; be sure the valves are wet. -. ‘CAUTION ion the SRV knob correctly when installing. The knob should be over the SRV and between two stoppers for SRV Air Cylinder. When correctly installed, the knob should be located over the SRV and you cannot see it easil Turn the pressure fixing screw clockwise to screw it into the shaft Close the display module and retighten the two screws. Close the cap piercer unil and retighten the two screws. ‘Tum on the power of the Main Unit. Verify the background values. 4. SRV 2, Pressure fixing screw Figure 6 272, Clean the WBC and RBC transducer chambers as follows: ‘+ Discard the contents of the chambers by executing the DRAIN SAMPLE procedure: Press [SELECT] [C] [6] [ENTER]. Open the front cover. Remove the rubber cap (1) at the top of each transducer chamber (see figure 7) Fill the chambers with 2mL hypochloryte. Go in the maintenance mode by pressing [C] [9] [1] [0] Press [SELECT] and move the cursor to program number 8: MAINTENANCE and press [ENTER]. Move the cursor to program number 2: COUNT SEQ. MODE and press [ENTER]. ‘The instrument pushes the hypochloryte through the apertures. Perform this program once again to push all hypochloryte through the apertures. Leave it for 5 minutes. Place the rubber cap back on both transducer chambers. Press [C] [0] to leave the maintenance mode. Perform twice an AUTORINSE procedure and verify the background results. 3. Perform daily maintenance if the Sysmex K-1000 isn't used for a couple of days before the weekly maintenance, perform the daily maintenance from point 2. Reference: Sysmex K-1000 Operator's Manual 28MONTHLY MAINTENANCE Monthly maintenance on the Sysmex K-1000 consists of = Cleaning the waste chamber and trap chamber ~ Cleaning the rinse cup - Cleaning the HGB flow cell - Checking the instrument on damages - Weekly maintenance - Daily maintenance 4. Clean the waste and trap chamber as follows: ‘+ Pull the front cover forward to open. + Discard the contents of the waste chamber by executing DRAIN SAMPLE procedure: Press [SELECT] [C] [6] [ENTER]. ‘+ Tum off the power of the Main Unit. Wait for the pressure to release (about 1 minute). + Tur counterclockwise the waste chamber fixing screw (2) and remove the waste chamber (3). Fill the chamber with 30mL hypochloryte. Leave it for 15 minutes. if necessary, clean the float switch Discard the hypochioryte. Tighten the waste chamber by turning the fixing screw clockwise. Pay attention for the o-ting (1). CAUTION Wear gloves when cleaning the waste chamber and trap chamber. These components may contain residual biological material, and constitute a biohazard. * Check if there is moisture or dirt in the trap chamber. + Ifnecessary, remove the fixation screw of the trap chamber (4). * Remove the white trap chamber tid by turning it counterclockwise. Clean the inside of the trap chamber with hypochloryte. Rinse the inside with distilled water. Dry the inside en place it back into the instrument. ‘Turn on the instrument. Residual materials automatically flushed away. 2. Clean the rinse cup as follows: + Turn off the instrument and wait for pressure to release (about 1 minute). Pull the front cover forward to open. Pull the rinse cup mechanism up carefully. Remove the cup from its hoker by pulling it upwards. Remove the silicone tube at the bottom of the cup. Rinse the cup with distilled water. Connect the tube to the cup and place the cup into the instrument. Turn on the instrument and check the function of the rinse cup. Figure 9 29. Clean the HGB flow cell as follows: Pull the front cover forward to open Discard the contents of the HGB flow cell by executing DRAIN SAMPLE procedure: Press [SELECT] [C] [6] {ENTER}. Pull the flow cell (1) a little upwards and remove the rubber cap on top of the cell Fill the flow cell with 2mL. hypochloryte. Leave this for 5 minutes. Discard the hypochioryte by executing DRAIN SAMPLE procedure: press [SELECT] [C] [6] [ENTER] Perform an AUTORINSE procedure. Check if the HGB blank value is 500 as follows: a. Be sure that the HGB-lamp and flow cell are clean, that the instrument is on for 30 minutes and is in the READY mode. b. Press [C] [9] [1 [0] to go in the maintenancemode. If the Sysmex K-1000 is in this mode, the sequence number is displayed in the right corner of the LCD screen. Figure 10 SEQ. STOP ok 00:15 HGB: 532 c. Press the START SWITCH to perform a blank count. Stop the instrument when the sequence number is 3 by pressing [SELECT] d. The HGB blank value is shown on the LCD screen. e. If the HGB blank value is correct, press [SELECT] to continue the count f. Ifthe HGB blank value is not correct, perform the following procedure: * Locate in the right top comer of the Sysmex K-1000 the HGB unit (1) with next to it the circuit board with the blank value potentiometer (2). * Adjust the blank value potentiometer to 500 + 50. Turning clockwise is increasing the value. * Press [SELECT] to continue the count * Perform another blank count by pressing the START SWITCH. Stop when the sequence number is 3 by pressing [SELECT] + Verify if the HGB blank value is 500 + 150. Is this not correct, go back to point f. * Press [C] [0] to leave the maintenance mode. ‘+ Close the front cover. Figure 11 304, Check the instrument on damages. Check the Sysmex K-1000 and the pneumatic supply for damages. If there are damages inform the service engineer. 5. Perform weekly maintenance. Reference: Sysmex K-100 Operator's Manual 31TECHNICAL MAINTENANCE Perform technical maintenance on the Sysmex K-1000 as follows: MAINTENANCE, QUATERLY HALF-YEARLY YEARLY a INSPECTION OF THE ELCTRONIC VOLTAGES INSPECTION OF THE PRESSURE AND VACUUM IN THE PUMP UNIT INSPECTION OF THE PRESSURE AND VACUUM IN THE MAIN UNIT. DISMANTLING AND CLEANING OF THE PUMP UNIT CLEANING THE WEC AND REC APERTURES. INSPECTION OF THE DIAPHRAGM PUMPS: INSPECTION OF TUBES INSPECTION AND CLEANING OF THE MASTER VALVES Set your initial after maintenance on the User maintenance schedule. 32QUARTERLY MAINTENANCE Quarterly maintenance on the Sysmex K-1000 consists of: ~ Inspection of the electronic voltages ~ Inspection of pressure and vacuum in the pump unit - Inspection of pressure and vacuum in the Main Unit 4. Inspection of the electronic voltages: + Open the top cover en the rear cover ofthe instrument by loosen the screws and remove the covers. Locate both power supply circuit boards. 4 Power supply board 5 2= Power supply board 6 ‘+ Inspect and adjust the power supply circuit boards as follows: Figure 12 ae [Adjustment [Test points | Description Power supply board (point No. 5 +: [(PeB NR. 4044) VR Tea [rpg |Adiust VR 1 at TP to 100 + 1.6 Vdc | Agustment — | Test points | point | Power supply board ~ No.6 vR1 Adjust VR 1 at TP 1 to 1.429 + 0.020 Vide (PCB NR. 4045) TRa |TP2 NONE [TP |TP4 | Verify that there is at TP 3 24 Vdc + Ifthe voltages are not present on the board or if they can not be adjusted, the power supply circuit boards must be replaced, * Turn the instrument on. + Perform an AUTORINSE procedure en verify the background values. 2. Inspect pressure and vacuum of the pump unit (figure 5) as follows: + The pressure and vacuum are specified as follows Pressure: 2.0 kg/em? 4 0.4 Vacuum: 480 mmHG or more + If the pressure is not correct, adjust the pressure with the pressure regulator. 33,The vacuum on the pump can not be adjusted. If the vacuum is too high or to low there is a malfunction in the system. If the vacuum is to low this can point to a broken membrane. On the Sysmex K-1000 a error message is displayed: NO DILUENT. Take the following action: a. Pinch the valve between the pump unit and the Main Unit. If the vacuum, increases this means that there is a leakage in the Main Unit. Inspect the pheumatic part in the Main Unit b. Ifthe vacuum stays the same, inspect the pneumatic unit and the compressor in the pump unit. The membrane is probably broken ©. Ifthe vacuum is higher then 600 mmHg, inspect if the tube between the pump unit and the Main unit not is pinched. Is this not the case, inspect the pneumatic part of the pump unit. 3. Inspect the pressure and vacuum on the Main Unit (Fig. 4) as. follows: The pressure and vacuum are specifies as follows: Pressure: 0.5 —_kglom?+ 0.05, Vacuum: 250 ming + 10 If the pressure is not correct proceed as follows: a. Pull the knob of the pressure regulator (2, fig. 4) out. b. Adjust the pressure as specified. c. Block the regulator by pushing it back. If the vacuum is not correct proceed as follows: a. Loosen the fixing screw (1) of the vacuum regulator (4, fig. 4). b, Turn the adjustment screw (2) until the specified vacuum is reached. cc. Tighten the fixing screw. Perform an AUTORINSE procedure and verify the background. results. Reference: Sysmex K-1000 Operator's Manual and Service Manual 34 Figure 13HALF-YEARLY MAINTENANCE Half-yearly maintenance on the Sysmex K-1000 consists of: - Dismantling and cleaning of the pump unit Cleaning of the WBC and RBC apertures Inspection of the diaphragm pumps Quarterly maintenance Dismantle and clean the pump unit as follows: Turn off the pump unit and disconnect the power cord and tubing. Loosen the 5 screws of the cover and remove it Loosen the 22 screws of the inside cover and remove it Locate the pump en mark the position of the top lid with a felt pen. Remove both lids of the pump head (7 Allen screws). Loosen the 4 Allen screws of both pump heads en remove the heads Inside the pump head fits 2 metal plates. Loosen the screw and remove the plates. Clean the pump head and the metal plates with alcohol. Clean the diaphragm with water and soap. Inspect the diaphragm on wear and tear and replace if necessary. Replace the pump in reverse order. Pay attention if the rubber gasket between the pump head and the lid is in the right place. Connect the tubing and the power cord. Turn the pump unit on Check the pressure and vacuum en adjust if necessary (see quarterly maintenance). 2= pump head 3 = rubber gasket 4= diaphragm FIGURE 14 2. Clean the WBC and RBC aperture as follows: + Press [SELECT] [C] [6] [ENTER] to execute the DRAIN SAMPLE procedure. + The contents of the transducer chambers are now emptied. + Loosen the fixing screw and remove the protection cover. (figure 15a) After removing the protection cover, the transducer chamber must pulled out carefully by turning it clockwise or counterclockwise. (figure 15b) * Clean the apertures with a little brush and hypochloryte. (figure 150) 35* After cleaning, put the transducer chambers back into the instrument, * Fix the protection cover and tighten the fixing screw. + Perform an AUTORINSE procedure en verify the background values. fo Ble) i | 5H]! 1 _ ll U [ 4 ea eet V4 FIGURE 154 FicuRE 168 rioure 150 4, Transducer chamber 3, Aperture 2, Fixing screw 4, Brush 3. INSPECTION OF THE DIAPHRAGM PUMPS. The following 7 diaphragm pumps are being used in the hydraulic system of the Sysmex K-1000. Pnumber [Function [Type Delivered/aspirated volume (DP 4 WBC lyse delivery | Diaphragm pump nr 6 assy _| 1.0 + 0.02 mL OP 2 [Hgb lyse delivery _| Diaphragm pump nr 5 assy | 1.0 + 0.02 mL RBC sample oP 3 Second aspiration [Diaphragm pump nr 8assy | 1.5: 0.05 mL DP 4 WBC rinsing Diaphragm pump nr6 assy [3.02 1,0 mL DPS ‘Sample aspiration | Diaphragm pump nr7 assy 10.100 — 0.115 mu i WB( i [pps HoreRES SPF | Diaphragm pump nr9 assy [2,0 +0. 02m Hgb dilution? OP7 rinsing Diaphragm pump nr 9 assy | 2.0 0.1 mL Table 2 jgb lyse diaphragm pump DP 2 /BC lyse diaphragm pump DP 4 3 = Whole Blood Rinse diaphragm pump DP 3 4= WBC rinse diaphragm pump DP 4 5 = Sample aspiration pump diaphragm pump DPS 6 = Hgb diaphragm pump DP 7 7 = Dilution diaphragm pump DP 6 Figure 16 36Inspect the delivered volume as follows: A. B, WBC lyse diaphragm pump DP 1: 1. Weigh an empty beaker on a good balance. 2. Press [C} [9] [] [0] to enter the maintenance mode. The sequence number is now displayed on the LCD screen. ‘Open the front cover, Open the operation panel and locate nipple A of master valve MV 24. Disconnect the tube from nipple A Connect a silicon tube (@ 4.0/2.0 + 10 cm long) on nipple A of MV 24, Place the other end of the tube in the beaker of point 1 Press the START switch. Lyse is delivered in the beaker during sequence 5. Weigh the beaker again, and caloulate the difference with the value of point 4 Repeat points 1 to 8 af least 3 times. 0. Verify the results: 0.980 — 1.024 gramme. The first time must not be calculated in the verification. 11. If the volume is not good, the diaphragm pump must bee adjusted according to. section 6.3.4 of Sysmex K-1000 Service Manual Be aoenog MV 19.8 — wae «fe] Te]|[8 (alg) |) Ble || 23) @ O)}/ 0 Hgb Lyse diaphragm pump DP 2: 1. Weigh an empty beaker on a good balance. 2. Press [C] [9] [.] [0] to enter the maintenance mode. The sequence number is now displayed on the LCD screen. 3. Open the front cover. 4, Open the operation panei and locate nipple A of master valve MV 19. Disconnect the tube from nipple A. 5. Connect a silicon tube (@ 4.0/2.0 + 10 cm long) on nipple A of MV 19, 6. Place the other end of the tube in the beaker of point 1 7. Press the START switch. Lyse is delivered in the beaker during sequence 5. 8. Weigh the beaker again, and calculate the difference with the value of point 1 9. Repeat points 1 to 8 at least 3 times, 10. Verify the result the verification, 11. Ifthe volume is not good, the diaphragm pump must bee adjusted according to section 6.3.4 of Sysmex K-1000 Service Manual : : 0.880 ~ 1.024 gramme. The first time must not be calculated in 37C. Whole blood Rinse diaphragm pump DP 3: 4. Filla beaker with a little bit more then #0mL diluent. 2, Weigh the beaker on a good balance 3. Open the front cover. 4. Open the operation panel and locate nipple A of master valve MV 12. Disconnect the tube from nipple A 5. Connect a silicon tube (@ 4.0/2.0 + 10 cm tong) on nipple A of MV 12. 6. Place the other end of the tube in the beaker of point 1 7. Press the START switch. During Seq-4 and Seq-10 diluent is aspirated. 8. Weigh the beaker again, and calculate the difference with the value of point 2. 9. Repeat points 1 to 8 al least 3 times, 40. Verify the results; 1.451 ~ 1.557 gramme. The first time must not be calculated in the verification 11. If the volume is not good, the diaphragm pump must bee adjusted according to section 6.3.4 of Sysmex K-1000 Service Manual. toto] 6 8) | @ > 7] 8 Es @ 9 e aa | iia a D. WBC Rinsing diaphragm pump OP 4 | 4. Weigh a beaker on a good balance | 2. Disconnect the tube from nipple 2 of the upper ceramic plate of the SRV. 3. Place the disconnected tube in a waste beaker (not the one of point 4). 4. Press the START switch, During Seq-5 diluent is delivered in the beaker. Discard the diluent. i 5. Press [SELECT] to stop the sequence after Seq-5. Place the disconnected tube from point 2 in the beaker of point 1. Press [SELECT] to start the sequence again. 6. During Seq-14 diluent is delivered in the beaker. 7. Weigh the beaker, and calculate the difference with the value of point 1, 8. Repeat point 1 to 7 at least 3 times 9. Verify the results: 2.004 ~ 4.049 gramme. The first time must not be calculated in the verification. 10. If the volume is not good, the diaphragm pump must be replaced. This pump is NOT adjustable. The procedure is described in section 6.3.5 of the Sysmex K-1000 Service Manual 38Upper ceramic plate SRV E. Aspiration diaphragm pump DP 5: 1. Filla beaker with more then 5mL diluent. 2. Weigh the beaker on a good balance. 3. Dry the aspiration pipette with a tissue, place the aspiration pipette in the beaker and press the START switch. Diluent will be aspirated, 4. Weigh the beaker again, and calculate the difference with the vaiue from point 2. Repeat points 4 to 4 at least 5 times. Verify the results: 100.6 ~ 115.54 ugramme. If the volume is not correct, the diaphragm pump must be adjusted according section 6.3.4 of Sysmex K-1000 Service Manual. oo F. Dilution diaphragm pump DP 6: . Weigh an empty beaker on a good balance. Fill an another beaker with al least § mL diluent. Disconnect the tube from nipple 2 from the upper ceramic plate of the SRV, Place the disconnected tube in the beaker of point 1 Place the aspiration pipette in the filled beaker from point 2 and press the START switch. The diluent will be aspirated. During Seq-5 diluent will be delivered in de ‘empty beaker, Press [SELECT] to stop the sequence after Seq-5. 6. Weigh the beaker from point 4, and calculate the difference with the value from point 4 7. Place the disconnected tube in a beaker. Press the START switch to start the ‘sequence again. During Seq-14 diluent will be delivered in the beaker, Discard the diluent. 8. Repeat points 1 to 7 at least 3 times. 9. Verify the results: 1.984 ~ 2.029 gramme. If the volume is not correct, the diaphragm pump must be adjusted according section 6.3.4 of Sysmex K-1000 Service Manual. Aen G. HGB diaphragm pump DP 7: 4. Weigh an empty beaker on a good balance. 2. Disconnect the tube from nipple 5 of the upper ceramic plate of the SRV. 3. Connect a silicon tube (@ 4.0/2.0 + 10cm long) on nipple 5. 4, Place the other end of the connected tube in the beaker form point 4. 5. Press the START switch. During Seq-5 and Seq-14 diluent will be delivered in the beaker. 6. Weigh the beaker again, and caloulate the difference with the value form point 1 7, Repeat points 1 to 6 at least 3 times. 8. Verify the results: 1.901 ~ 2.110 gramme. If the volume is not correct, the diaphragm pump must be adjusted according section 6.3.4 of Sysmex K-1000 Service Manual, 4, Perform quarterly maintenance. Reference: Sysmex K-1000 Operators Manual and Service Manual. 39YEARLY MAINTENANCE Yearly maintenance on the Sysmex K-1000 consists of: - Inspection and replacing of tubes ~ Inspection and cleaning of the master valves - Half-yearly maintenance 1. Inspect the tubing and replace if necessary: ~ Replace the tube from the main unit to the waste container. Inspect the rest of the tubing on: a. damages b._ pinching s, blocking d._ ifthe tube is free ~ Hone of the above points is found, the tube must be replace or the situation must be cleared. 2. Inspection and cleaning of the master valves: The following master valves must be inspected: g { @ ia beak ———> valve unit Assy 19 ° ° Veena O) Ll bo [> ® Valve unit Assy 20 iC) A [ale ea fie > Vaive unit Assy 24 | Iie |e 7 [a kal Yo 8 F iS Ao bs Valve unit Assy 22 a i id Valve unit assy 19: MV 4; MV 2; MV 19; MV 20; MV 21; MV 22; MV 23; MV 24: MV 25 and MV 26. Valve unit assy 20: MV 9; MV 12; MV 13 and MV 18. SV 15 is a solenoid valve and is NOT needed to inspect. 40- Tur of the instrument. Wait 1 minute to get the vacuum low. - Open the front cover. - Locate the operation panel - Locate the vaive units. - Remove the two or three screws of a Master Valve. Diaphragm - If there is dirt or salt crystals on the diaphragm, clean the diaphragm. Use hypochioryte and a soft tissue. ~ If there is NO pressure, the piston should be in the upper position due to the spring. This is easily to check. Put a finger on the piston and press downwards. - Put the Master valve together. - When all Master valves are inspected, perform a background check. 3. Perform half-yearly maintenance. Reference: Sysmex K-1000 Operators Manual and Service Manuel atFLOWSHEET Sheet 1 Technical User maintenance maintenance Sheet 2 Month Daly ‘Weekly thainianance maintenance maintenance ¥. v y Cleaning ofthe Crean ihe waste Cleaning after Sample Rotor chamber and the use Valve trap chamber \ yv v y Perform an Giean tne RBC Giean he Rinse AUTO RINSE. and WBC cup cycle transducer chambers ve —__¥ Check water love! Clean HGB tow drain pneumatic cell unit trap chamber dae HEEL EEE eave Draining ofthe inspection on drain filler assy damages of the K- 1000 and the eure unit etna on fe ae schedule 42Sheet 2 Technical Maintenance Yearly Maintenance ‘Quarterly maintenace Half-yeariy maintenance v cay. Inspection of the Dismantling and Inspection and electronic cleaning ofthe replacing tubes voltages pump unit ata y inspection Cleaning the inspection and pressure/vacuum RBC and WBC cleaning of the of the pap unit apertures Master valves v Inspection Inspection of the Pressurelvacuum daiphragm pumps ofthe Main unit Set initial on maintenance schedule 43Product Information Reagents for Sysmex analysers Wits Boos ‘Spano Emergency a ocel Persmeters | oluent | tysing | reagents | cleaning | clearing | Controls Fiaata Gamer | — Poaly [Ow TOO PS | Datecaeage | Peobaan Pur | Patel Coal 10 Mypacvote 03% esta, rao, ateo,| WGC Bias Ton Pus | yeereoO Darecawge | Pretioan lus | 8 Parmar 6170, £160 {ols CH Free) Hypachloste (200. sutonate) F sores, Fa0o. F500] WHC] Bisa ToD Pus | Teens 7 eaeartge | Precioan Fick | 8 Pararsier 520 | (eom-cutomaies) (aso CH Free} Fypocnve ie Fea FG, FORO] WBC. 1, | DTD PR] yea Datecotge | Provean Pus |B Parameter Mr, mac {som-automaea) ypocioite os% © Banas FSOGD | WC, CF 1, | OHO 10S Pa | Cyr VaR ‘Deeseeigs | PreleanPios | 6 Paranal dra, om tise . Te eies FRG, | — WRC] iid TOD Ps | “Gy ToT Typacmome | Pea Pur |e Parameer oe 000, Ke500;2¢ | WBE, LL, HHypocnoie | Kou "ih i Ds oto Product No, Reagent 3961 iid 100 Pies ares Lyzeralobin 3077 yzeralobin 3880 Lyzerglobin CN Free: 3854 Lyrerelobin CN Free sr70 Lyzeralobi I (Gyanide/S05 free) sae Gytitet 1000 (Cyanige/S0s tree) Contes Pack size 2oIIter 5x15 mi 500 mi ex 15m 500 mi 10x10 Product No, Reagent Pack site Noles 3763 Detectctorge Siter 3768 Detectoterse 1 er 761 Detecioterge Cone 1 Mer fr 20 Her 3800 ProGlean 5 iter 3201 ProGlean Plus 100m! at? Hypochioste 0.5% titer Contains tobe protective and noise suppressing compounds ‘8 Parameter Coniro! avaiable in 2.5 ml, 25 mi pierceable, 4.5 mi perceable ond 8 ml vials in three levels Do Parameter Conta or use on NE series avaiable in plerceable, 45 ml vals (see also page 26 and 32), iff Cont for use on a K series analysers with il Part cif if, avaiable n 25 mi itis Recommended to partcipate i J. 7-Bakers fee externalinieraal qually assessment program Rapid Stat or Easy Stat tis akvays Recommended, in case of changing reagent type or reagent otign, to check whether a re-caibration is required 44J.T. Baker Hematology Controls: Which Control for which analyser? Conitor Characteristics Parameters instruments (group) 8 PMControl Multi instrument WBC.HbHeLMCV, | Allinstruments from all Rapid Stat RBC, Pits, MCH, MCHC | known brands (except 4 months stable NE 8000) Most used controt | 12 PMMControl TDI Controf ‘ATS PMC values +3 [A Coulter Ti DifF 4 months Stable part Diff (LIM.G) | versions, Nihon | Kohden, Erma, Melet, 78 PMControt Diff Control ‘As 12 PMC | Madonic Dif series months Stabe | 500 ane 00 series | 20 PMControl Ful Dif ‘As T2PMC + Ba and — | Sysmex NE series 3 months stable EO ‘CD Controls Ful Dif ‘As 12 PMC | Abbott GD series 3 months stable inctuding 4000 Ki TH Dif Control As 12 PMC | Sysmex K series and 3 months Stable Biochem $000 series AC Dif IW Diff Control ‘As 12 PMC Sweiab AC diff series ‘3 months Stable ‘5D Controls Full diff control AS 12PMC+e0and | MaxM and related 3 months stable Baso's 45Product Information 8 Parameter Control Product description 8 Parameter conitol is a whole blood contol preparation, intended for use in Hemocytomelry to monitor dally accuracy and precision of cell analysers and menvat ‘analytical procedures. ingredients 8 Parameter Control contains Human RBC, simulated WAC and mammalian platelets. Allcells are suspended ina plasma lke fluid. 8 Parameter Control is ‘manufactured in such a way that it simulates whole blood. When used on automated cell analysers, the following hemocytometric values may be obtained {WBC, RBC, Piatelels, MCV, MCH, MCHC, Hematocrit, ROW and all other values ditectly derived from those listed, No differential WBC analysis is included. Suitability Expected Histograms. 8 Parameter Control is multi suitable and may be used oP coors, fH comes ‘on all cel analysers: Coulter, Sysmex", Abbott, Medonic, ae Swelab, Hycel, Elma, Nihon Konden, dloChem, Danam, Goniraves, Technicon-Bayer, Sebi, ABK, Labover, AL ‘Systems. FA * decent NE series Assay values: ‘Al deliveries ae accompanied by assay values forthe ° on following insvuments eee: Coulter sem-atomates, 7,57 Maxm,STKS, MD setes, Act. Sysmex F,K, Medonic series, Swelab AC 900 i er series, Niton series MEK ,ABX sores, Abbott CO 1600/2000, Serono-Biachem series, ieton, Product Stability PE eet Pao 8 Parameter Controt is stable for 4 months. Opened vials pe remain stable for 3 weeks, when used in accordance ones ee ‘nth the instructions for use. Unopened vials may be Availabilty stressed for 48 hours at 18° C maximum, without losing —_& Peramoter is availabie inthe following pack sizes prockt integly. ‘Volume per] Type of package [Product i vial Taw Nom | Fah ‘Adaitional a Users of Parameter conto! may paticipale in Tal |Seawesp Ba | BE | BIB JT.Baker's detailed between lab-between instrument 2.5mi__| Screw cap 3724 | 9728 | 3726 ‘ually ataessment program, Rapis Stat 45m |Perceable crew] o701 | 3702 | 3703 ap (ocutana 28) {8 Perameter contol comes in the fofowing levels and iin Pen [cont [3707 | BVAE | STS | S728 | TES | STE Parameter —~ [Coa [Woraal [High Ee 5 wesx30% [20 |'¥03_|200 375 [3x25 m1 Tyas Re x 101A 218 447 5.57 ‘3747 [4 x2.5 m1 4 Hemagia ga [1 [75 fe Sraafax6 mi a Het i730 foo.s S743 [de 75 ml i EVE a 3760 [4x8 mi] MICH pg 26.4 30.2 327 3751 [6x2.5mi 7 a T CHE gi} 352-—[ 555 [387 pis x10% [30 [25588 Delivery schedule and ordering information. iowa ee & Parameter Contos manufactured and delivered on a ae sete 49 weeks schedule. Every dd week of the folowing 46 celendar months: March, June, September, December. Orders are guaranteed when received 7 weeks in advance,Product Information K-Diff Control For Sysmex and Biochem Analysers. Product description K-Diff contol is a whole blood control preparation, intended for use in Hemocytometry to monitor daily ‘accuracy and precision of coll analysers and manual analytical procedures. Ingredients K-Diff Control contains Human RBC, simulated WBC ‘and mammalian platelets. All cells are suspended in a plasma like fuid. K-Diff Control is manufactured in such away that i simulates whole blood. When used on ‘aulomated coll analysers, the following hemocytometric values may be obtained: {WBC, RBC, Piatolets, MCV, MCH, MCHC, Hematocrit, ROW, LY, %6Mid, % Gr. and all other values directly derived from those listed. Diff Control is suitable for use on alt Sysmex K series (800, K-1000, K-4500 en KX-21) analysers and ‘Serone Biochem £000 and 9000+series. Assay values Al deliveries are accompanied with assay values for the following instruments: ‘Sysmex K-series ans Serono-Blochem 8000 series. Product Stability Diff Control is stable for 4 months, Opened vals romain stable for 3 woeks, when used in accordance with the instructions for use. [Unopened vials may be stressed for 48 hours at 18° C ‘maximum, without losing product integrity Additional Users of K-Diff Control may participate in J.T.Baker's limited between lab-quality assessment program, Easy Stat Expected Histograms. WESoy Te ae ee ue fae ate 3h 0 40.721 Laie 0.360 “chee Reo) s0c104 Neurs — -01258 Reur, “O.gse Conan "2.0 saa Uupna "e ae hoe ey te ase Neore 7m NEU : cm) an) ma ROWS = 28,8 8 " row se 0 tro roan Filer ane? Low on Sysmex Normal on Sysmex aa | HBC I toe KDiff contro! comes in the following levels and values. 89000 WAC Histogram on Normal Parameter Low | Normal | High Availability WES x 10% zy Bett eee K.Diff Control is evailable in the following Ly % ms | 364 | 118 pack sizes, Mx % 3.0 38 | 10.9 Neut % 245 | 648 | 77.2 eeeeree gee eeeee rere oe 2 221 | 404 | 5.80 vial package RBC x10 a Tow [Norma] Fah Hemoglobin gia sa | 19 | 177 . Het %, 155 | 31.3 | 456 25m Screw cap_[ 3008 | sa57 | 3098 MCV fl 702 | 775 | 83.0 MCH pg. 26.7295 | 32.2 Delivery schedule and ordering information, MCHC gil 38.0_| 38.0 | 38.8 KDiff Control is manufactured and dolivered on a Platelets x 109A 60. 199 | 420, fa weeks schedule. Every drd week of he Fate 75 a TF folowing calendar months: February, May, 47 August, November. Orders are guaranteed when received written 7 weeks in advance.Priming and Calibration general information Cell analysers have to be primed in case reagents from a different source are installed. Although reagents from different sources may be equal in its function, different components might be used. AS we are not fully aware of all components in 3rd parties reagents itis always advised to do a priming procedure after installation of J.T. Baker reagents. Warning: in case reagents from different sources are mixed in the analyser, erroneous results may appear. This procedure does not guarantes that results are accurate. It only guarantees that resus are in line with those obtained with previous used reagents. For accuracy calibration we refer to the Cal Set 1 procedure or to the whole blood calibration procedure. Normally only Hemoglobin and/or MCV/Hct need to be calibrated when changing the original by J.T. Baker reagents, General priming and Cal-Set 4 calibration procedure. 1. _ First of al, be sure that the instrument is working properly before starting to change the reagents, 2. For priming Mallinckrodt Baker reagents, take the priming procedure as described for the analyzer. 3. Start to Prime (install) the reagents. » Ifthe START-UP or blank counts are within specified limits, calibration according Cal-Set 4 procedure should be done, 5. Read the insert sheet of Cal-Set 1 and use the blank form to write down the measurements. ° Calibrate the parameters, which need calibration 7. Toenler the new calibration factor into the calibration menu of the instrument, the calibration procedure in the distributors catalogue 1999/2000 should be used. 8. Check finally the calibration as described by the insert sheet of Cal-Set 1 Note:On request a whole blood calibration procedure is avaitable, 48Gal-Set 1 Calibration Set Intended use Cal-Set 1 Is designed for use in the calibration of hematology instruments in which the cell counting and sizing is based on the detection and measurement of changes in electrical resistance, produced by a pparicle suspended in a conductive diluent, traversing a small aperture. Values are provided for WBC, RBC, Hab, MCV and PLT. ‘Summary and principle ‘The WBC, RBC, Hab, MCV and PLT parameters on hematology instruments require calibration on a periodic basis. Cal-Set 1 is a slable preparation which can be used to perform the calibration, The assigned values for Cal-Sel 1 are obtained from reference methods. Reagent ‘CalSet 1 contains human erythrocytes, mammalian leukocytes and platelets in plasma-like uid Product no. and packsize 3940 Cal-Set 1 Calibration Set 2x 5 ml Required separately 8 Paramoter Control Storage and stability Open viel stabilly is 2 weeks provided the vials are handled property, The vials must be mixed according to instructions before each sampling and should be stored, ightly capped, at 2-8 °C vihen nol in use. See Instructions for use section for detailed handling directions. Unopened vials stored continuously at 2-8 °C are stable until the expiry date. Indications of deterioration Discoloration of the supernatant fluid may be caused by overheating ar freezing during shipping or storage. Examine vials for excess hemolysis. calibration required? is required when during the quality contro! process certain parameters show a strong deviation ‘rom the listed assay values, on condition that the reagents and the instrument itself are working propery. In the flow diagram below o simplo calibration questionnaire is presented, at 4. Alte fist reagent installation When to calibrate? > | 2. Ater regular service 3. 1n case of abnormality during OC Reagents are OK? Otherwise, connect new reagents |) Catbration required! co | Instrument performance OK? LS Ginense, troubleshoot problem ‘ualty Contot8 paramere contol Nema 149 an ‘Kesey Vane Ho 107 106 ga Caibraton requ, bocause Ho 5143 is ovo eoge 313.7 —---— Za z 13.4 Phan, oPococcd™ tnd Pasha Poin f Cog PoP > 125 ° 20 days 40 60 49How to calibrate? In the flow diagram below a callbration procedure according Cal-Set 1 is presented. Whole human blood calibration according the ICSH reference methods Is the best ay of calibrating an instrument, but ths Is very laborious. Therefore Cal-Set 1 is a very good approach, because calibration values of Cal-Set 1 are ‘established by using the ICSH reference methods, 4, Allow Cal-Set 4 to come to room temperature (90 min.) Mix gently by inverting the bottie at least 20-times, { 3. Analyse 11-times Cal-Set 1 as regular blood cample. Use table 1 of the Calibration Worksheet fo list all measurements. Reject the frst sample. The first test should be considered as primer, I 4. Calculate the Mean Value out of the 10 tests. The assigned valuos are listed in table 4 of the Calibration Worksheet, Calculate the difference between the Assigned Value from the Assay Value Sheet and the Mean Value analysed, The Tolerance limits +/ are listed in table 1 of the Calibration Worksheot. 6 Calculate New Calibration Factor by: Assigned Valu (Old Calibration Factor x Mean Value Analysed ‘Exampie of calculation ‘paler (ebsolate factors) 1.005 x 10.5795= 1.114 Gouller MAXM I STKS. ‘Automete calevation within the calibration menu ‘oa Sysmex (perceniage fadlara) | 100.5% x 10.5/9.5 = 111.1% ‘Abbott Cel-Dyn (absolute factors) | 1.005 x 10.5 78.5 = 1.111 [ABX Micros (absolute faciors) 1005 x105/0.5= 4.111 ‘ABX Minos (percentage factors) 100.5% x 105/95 = 111.1% Nihon Kohden (absolute factors) [1006 x 10.505 = 1711 BioChem (Sereno) 8000 ‘Automatic calculation within the calibration menu Use table 2 of the Calibration Worksheet to ist ll new calibration factors. 8, _ Introduce the new factor nto the calibration factor menu of the instrument, with reference to special instrument procedures. 8. Check the calibration by analysing 5.times. Cal-Sot 4. Use table 3 of the Calibration Worksheet to list the verificalion of calforation. 10. Verify daly routine by processing tr-level 8 Parameters Control through the instrument, Values should fall within the ranges provided. Warning and precautions Warning: Potential bohazardous material Cal-Set 1 is intended solely for IN VITRO diagnostic use by trained, qualified personnel. Human blood ‘components used in Cal-Set 1 were found to be non-reaclive for HBsAg and antibody to HIV when tested wilh licensed reagents. No known test methads can provide complete assurance that products derived from human blood will not transmit infectious diseases. Follow the same precautions as with patient samplos whon handling or disposing of vials, Do not Inject or consume by mouth, Avoid direct mouth pipetting of samples. 50

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