Terumo Harvest SmartPReP 2, Operator'S And Service Manual

Page 1: ...4531200 1042 Operators and Service Manual SmartPReP 2 Centrifuge System For Platelet Bone Marrow And Adipose Tissue Concentration ...

Page 2: ...UP 8 INSTRUCTIONS FOR USE 8 Loading the Process Disposables APC BMAC 9 Loading the Process Disposables AdiPrep Adipose Transfer System 10 CONTRAINDICATIONS 10 WARNINGS 10 CAUTIONS 11 SAFETY 12 SYMBOLS 12 TROUBLESHOOTING CHART 13 MAINTENANCE 15 SERVICE 16 WARRANTY SERVICE 16 NON WARRANTY WORK 16 RETURNED GOODS POLICY 17 AUTHORIZATION 17 REQUEST FOR RETURN AUTHORIZATION 17 FREIGHT RETURNED GOODS 17 ...

Page 3: ...IONS 19 ENVIRONMENTAL CONSIDERATIONS 19 ELECTROMAGNETIC COMPLIANCE 19 TECHNICAL INFORMATION SMP2 serial numbers 6000 and greater 22 PHYSICAL SPECIFICATIONS 22 STANDARDS 22 ELECTRICAL SPECIFICATIONS 23 ENVIRONMENTAL CONSIDERATIONS 23 ELECTROMAGNETIC COMPLIANCE 23 ...

Page 4: ...clinical laboratory or intraoperatively at point of care for the safe and rapid preparation of platelet poor plasma and platelet concentrate from a small sample of blood and for preparation of a cell concentrate from bone marrow The AdiPrep Adipose Transfer System is used in medical procedures involving the harvesting and transplanting of autologous tissue The AdiPrep system is used for concentrat...

Page 5: ...rocess is complete Control Panel POWER Illuminates when the unit is plugged in INTERRUPTED Upon initial power up the INTERRUPTED LED will illuminate this is normal operation It also illuminates when the control system senses an electronic failure If this condition is detected the centrifuge is brought to a stop and cannot be restarted until the fault condition is corrected The INTERRUPTED LED is a...

Page 6: ...OWER INTERRUPTED LID OPEN IMBALANCE DONE TIMING LID STOP PRP BMAC 0 Control Panel POWER Illuminates when the unit is plugged in INTERRUPTED Upon initial power up the INTERRUPTED LED will illuminate this is normal operation It also illuminates when the control system senses an electronic failure If this condition is detected the centrifuge is brought to a stop and cannot be restarted until the faul...

Page 7: ... for proper use of those kits HAT kits not available in the U S Balance Weight Chart BW 20 Balance Weight TA 20 Balance Weight Tube Adapter Used with HAT Kit BW 20 is needed for opposing rotor BW 60 Balance Weight TA 60 Balance Weight Tube Adapter Used with HAT Kit BW 60 is needed for opposing rotor BW 30 Balance Weight TA 30 Balance Weight Tube Adapter Used with HAT Kit BW 30 is needed for opposi...

Page 8: ... and it is safe to open the centrifuge cover The centrifuge is now ready to process blood marrow or adipose tissue NOTE Follow established protocols and procedures prior to placing the SmartPReP 2 System into service NOTE If additional protective earthing grounding is required use the green yellow terminal on the back of the instrument CAUTION Do not force processing disposable into rotor trunnion...

Page 9: ...ucts may cause illness injury or even death Discard all unused components at the end of the procedure Loading the Process Disposables APC BMAC 1 Press the LID button and open the lid 2 Load the swinging trunnions as described in one of the five scenarios Be sure to line up the white dot indicator on the trunnion with the white dot on the PD Rotate the PD as necessary to ensure proper alignment CAU...

Page 10: ...lid 2 Press the green START or the blue PRP button 3 The TIMING window will display the remaining time of the cycle When the display indicates 10 approximately 4 minutes have passed press the red STOP button 4 When the rotor has stopped press the LID button and remove the PDs CONTRAINDICATIONS The use of the SmartPReP 2 System may be contraindicated when there is Clinical or laboratory evidence of...

Page 11: ...ked with a biohazard symbol double bag or place hazardous waste in a protective container discard sharps in rigid puncture proof and leak proof sharps container Incineration and decontamination by autoclaving are the currently recommended methods for disposing of blood marrow adipose tissue samples and blood marrow adipose tissue products Aseptic technique should be used when aspirating and dispen...

Page 12: ... allow the user to stop the process safely and quickly SYMBOLS If applicable the following symbols may appear on the SmartPReP 2 System Attention Consult Accompanying Documents Power on Start WEEE Compliant Producer Stop Do Not Reuse Open Lid STERILE R EO A Sterilized Using Irradiation Ethylene Oxide Steam or Dry Heat Equipotential LOT Lot Code Alternating Current Manufacturer Interrupted Consult ...

Page 13: ...th a round magnet attached inside the lid lip Contact Harvest Imbalance Imbalance light is on Incorrect balance weight used Confirm that your process disposable volume and the balance weight are correct Imbalance light is on The machine was damaged in shipping Power cycle the machine and retry Imbalance light is on The machine was bumped after start Power cycle the machine and retry Contact Harves...

Page 14: ...latelet concentrate High RBC count Verify patient s blood count Contact Harvest Too loud Too loud Rotor is loose Fully seat and tighten the rotor knob clockwise Too loud Disposables are not seated correctly Verify that the disposables are fully seated PD s should not touch lid glass Test the SMP2 machine run empty to verify decant function Too loud Disposable vs BW Weights are on the imbalance thr...

Page 15: ...ts the recommended maintenance procedures that should be followed CLEANING EVERY USE CAUTION Ensure line cord is disconnected from power source prior to cleaning Do not use abrasive cleaning agents Do not use solvents or strong alcohol solutions Do not immerse any part of the SmartPReP 2 System in liquids The SmartPReP 2 System should be cleaned after each use and or after any spill of liquids For...

Page 16: ...y TEST RUN Monthly or AS NEEDED BASIS Perform verification of centrifuge process from start to finish Commence a test run by closing the lid firmly verify that only the POWER light is illuminated press START PRP or BMAC Confirm the system performs a first spin coast down and stop second spin coast down and stop Process is complete in approx 14 minutes SERVICE Harvest Technologies Corp or its autho...

Page 17: ...rchandise must be returned FREIGHT PREPAID Any merchandise returned as freight collect will be refused by Harvest Technologies and returned to the customer at the customer s expense LIMITED WARRANTY The SmartPReP 2 System is warranted to be free from material and workmanship defects for a period of one 1 year from the date of purchase abuse and or impact damage excluded Harvest Technologies reserv...

Page 18: ...rtPReP 2 System has been tested and conforms to the following standards UL 61010A 1 First Edition 2002 Electrical Equipment for Laboratory Use Part 1 General Requirements UL 3101 2 20 First Edition 1997 Electrical Equipment for Laboratory Use Part 2 Laboratory Centrifuges IEC 60601 1 2 2001 Medical Electrical Equipment Part 1 General Requirements For Safety 2 Collateral Standard Electromagnetic Co...

Page 19: ...s long as the unit does not slide off the intended surface ELECTROMAGNETIC COMPLIANCE Special precautions regarding EMC Do not stack SmartPReP 2 Centrifuges on other medical electrical equipment Always check for normal operation when the SmartPReP 2 Centrifuge is moved to a new location Portable and mobile RF communications equipment can effect medical equipment WARNING This equipment system is in...

Page 20: ...ontact 8 kV air 6 kV contact 8 kV air Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Electrical fast transient burst IEC 61000 4 4 2 kV for power supply lines 1 kV for input output Lines 2 kV for power supply lines Not applicable for input output lines there are no input output lines Mains power quality shoul...

Page 21: ...tromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the SMP2 is used exceeds the applicable RF compliance level above the SMP2 should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the SMP2 b ...

Page 22: ...ollowing standards STANDARDS Standard Description UL 61010 1 Issued 2004 07 12 Ed 2 Rev 2008 10 28 UL Standard for Safety Electrical Equipment For Measurement Control and Laboratory Use Part 1 General Requirements CAN CSAC22 2 61010 1 Issued 2004 07 01 Ed 2 Standard for Safety Electrical Equipment For Measurement Control and Laboratory Use Part 1 General Requirements Included when done concurrentl...

Page 23: ...se rating 5 Amp time delay glass tube x 1 5 Amp time delay glass tube x 1 2 5 Amp time delay glass tube 5 x 20mm ENVIRONMENTAL CONSIDERATIONS Temperature limit Operational 10 C 30 C 50 F 86 F Storage 40 C 66 C 40 F 150 F Humidity Limit Operation 10 90 non condensing Storage 10 90 non condensing Minimum clearance distance around unit 3 inches There is no need to secure the unit with straps or other...

Page 24: ...ctromagnetic environment specified below The customer or user of the SmartPReP2 should ensure that it is used in such an environment Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment Guidance ESD IEC 61000 4 2 6kV Contact 8kV Air 6kV Contact 8kV Air Floors should be wood concrete or ceramic tile If floors are synthetic the r h should be at least 30 EFT IEC 61000 4 4 2...

Page 25: ... from fixed transmitters as determined by an electromagnetic site survey should be less than the compliance levels V1 and E1 Interference may occur in the vicinity of equipment containing a transmitter Recommended Separation Distances between portable and mobile RF Communications equipment and the SmartPReP2 ME Equipment and ME Systems that are NOT Life Supporting Recommended Separations Distances...

Page 26: ...8 0 www harvesttech com US and Foreign Patents Pending Harvest SmartPReP APC BMAC SmartJet AdiPrep and accelerating healing naturally are registered trademarks of Harvest Technologies Corporation Terumo is a registered trademark of Terumo Americas Holding Corporation US patents issued 8 152 708 7 699 766 RE38 757 RE38 730 5 895 346 5 707 331 US and foreign patents pending ISO 13485 Certified EC RE...