Related Manuals for Terumo Harvest SmartPReP 2
Summary of Contents for Terumo Harvest SmartPReP 2
- Page 1 Operators and Service Manual SmartPReP® 2 Centrifuge System For Platelet, Bone Marrow And Adipose Tissue Concentration 4531200 / 1042...
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Page 2: Table Of Contents
® SmartPReP 2 SYSTEM OPERATOR’S AND SERVICE MANUAL Table of Contents ABOUT THIS MANUAL ........................4 INTENDED USE ..........................4 SYSTEM CONCEPT .........................4 DESCRIPTION (SMP2 with serial numbers 0101-5999) ..............5 Hardware ..........................5 DESCRIPTION (SMP2 with serial numbers 6000 and greater) ............5 Hardware ..........................5 ACCESSORIES ..........................7 HARDWARE SET-UP ........................8 INSTRUCTIONS FOR USE .......................8... - Page 3 STANDARDS ........................... 18 ELECTRICAL SPECIFICATIONS ....................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 3 of 26 4531200 / 1052...
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Page 4: About This Manual
ABOUT THIS MANUAL Messages that are headed by “NOTE:” indicate information or procedures that if not followed correctly can cause improper results. Messages that are headed by “CAUTION:” indicate information or procedures that if not followed correctly can cause improper results and damage to the equipment. Messages that are headed by “WARNING:”... -
Page 5: Description (Smp2 With Serial Numbers 0101-5999)
DESCRIPTION (SMP2 with serial numbers 0101-5999) Hardware The SmartPReP 2 System (SN 0101-5999) is similar to a general purpose swinging bucket centrifuge with the following exceptions: The bucket insert accepts only the Harvest processing disposable (PD) The bucket orientation (horizontal or vertical) is automatically controlled in order to perform decanting The automated dual-spin centrifugation process is fixed and cannot be modified by the user, thus ensuring reproducible results... - Page 6 DESCRIPTION (SMP2 with serial numbers 6000 and greater) Hardware The SmartPReP 2 System (SN 6000 and greater) is similar to a general purpose swinging bucket centrifuge with the following exceptions: The bucket insert accepts only the Harvest processing disposable (PD) The bucket orientation (horizontal or vertical) is automatically controlled in order to perform decanting The automated dual-spin centrifugation process is fixed and cannot be...
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Page 7: Accessories
Serial Number 0101- 5999 Serial Number 6000 > SMP2 Control Panels Open Lid Process Platelet Concentrate Process Adipose Concentrate Process Bone Marrow Concentrate Stop System ACCESSORIES The SmartPReP 2 System is compatible with Autologous Platelet Concentrate (APC+) Procedure Packs, Bone Marrow Aspirate Concentrate (BMAC) Procedure Packs, and AdiPrep Adipose Transfer System (AATS). -
Page 8: Hardware Set-Up
HARDWARE SET-UP The SmartPReP 2 System is packaged in one box. Verify that the box contains one (1) SmartPReP 2 centrifuge, line cord, and Operator’s and Service Manual. NOTE: Save box, packaging and rotor support foam for future use. 1. Remove the SmartPReP 2 centrifuge from the box and place on a sturdy counter or stable cart. Remove all shipping restraints and inspect for damage. -
Page 9: Loading The Process Disposables - Apc & Bmac
Two Place Rotor Scenario 1 – One properly filled equal volume PD in each trunnion. (2 total) Scenario 2 – One properly filled PD in one trunnion and one balance weight (of equal weight) in the opposing trunnion. Four Place Rotor Scenario 3 –... -
Page 10: Loading The Process Disposables - Adiprep Adipose Transfer System
Loading the Process Disposable – AdiPrep Adipose Transfer System Note: The Adipose Hardware Kit (AHK-1) is required to operate the SMP2 System with the AdiPrep process disposable. See Scenarios 1 and 2 for adipose processing. Install the two adapters into the rotor trunnions Be sure the adapter is properly seated with the white dots aligned as shown. -
Page 11: Cautions
Risk of electrical shock, do not attempt to service electrical components; refer servicing to qualified personnel. Plasma, platelets and cell concentrate prepared with this system are not intended for transfusion. Changes or modifications to this unit not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment. -
Page 12: Safety
SAFETY Safety features for the SmartPReP 2 System are constantly monitored and controlled to ensure safe operation of the unit. The possible system faults that are monitored are: Open Lid: A sensor on the lid ensures that the SmartPReP 2 system is never operated with the lid open. -
Page 13: Troubleshooting Chart
TROUBLESHOOTING CHART Symptoms Possible Cause Possible Solution Cannot resolve means go to next step Interrupted Interrupted light is on. Customer hasn’t opened Open the lid and it will clear the interrupt the lid yet circuit. This is designed to happen on first power up! Interrupted light is on. - Page 14 Symptoms Possible Cause Possible Solution Cannot resolve means go to next step No power No power Not plugged in Verify that the machine is plugged into appropriate voltage 100V/115V/230V. Try powering another device. Check wall switch, power strip? No power Fuses are blown.
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Page 15: Maintenance
MAINTENANCE The SmartPReP 2 System requires no calibration and is designed for minimum maintenance. Internal software monitors every process run from start to finish. If the timing or RPM vary more than the specifications listed below the unit will stop and the Interrupted light will illuminate. Optional - SPEED VERIFICATION The centrifuge has a set speed protocol with two points that can be confirmed as follows: Time... -
Page 16: Service
DECONTAMINATION PROCEDURE AFTER BLOOD SPILLS or AS NEEDED For disinfecting/decontamination, spray the unit with a 10% bleach/water solution and wipe with a damp cloth that has been wet with the 10% bleach/water solution. Allow unit to dry before returning to service. A dry cloth or paper towels may be used to dry the unit. -
Page 17: Returned Goods Policy
RETURNED GOODS POLICY AUTHORIZATION The customer must receive authorization from Harvest Technologies before merchandise can be returned. Unauthorized returns will not be accepted and will be returned to the customer at the customer’s expense. REQUEST FOR RETURN AUTHORIZATION The request for Return Goods Authorization Number (RGA) must include: 1. -
Page 18: Technical Information (Smp2 Serial Numbers 0101-5999)
TECHNICAL INFORMATION For SMP2 serial number 0101-5999 The Harvest SmartPReP 2 Centrifuge meets the requirements for leakage current and hi-pot testing listed in BS EN 60601-1 and UL 2601-1 standards for Medical Electrical Equipment. (Less than 100µA on model SMP2-100 and SMP2-115) (Less than 500µA on model SMP2-230) -
Page 19: Electrical Specifications
ELECTRICAL SPECIFICATIONS Model # SMP2-100 SMP2-115 SMP2-230 Input Voltage (VAC) Operating Frequency (Hz) 50/60 50/60 50/60 Rated Current (Amps) Fuse rating 5 Amp, time delay, 5 Amp, time delay, 2.5 Amp, time delay, glass tube, ¼” x 1¼” glass tube, ¼” x 1¼” glass tube, 5 x 20mm ENVIRONMENTAL CONSIDERATIONS Temperature limit:... - Page 20 Guidance and manufacturer’s declaration – electromagnetic emissions (Table 201) The SMP2 is intended for use in the electromagnetic environment specified below. The customer or the user of the SMP2 should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment –...
- Page 21 Guidance and manufacturer’s declaration – electromagnetic immunity (Table 204) The SMP2 is intended for use in the electromagnetic environment specified below. The customer or the user of the SMP2 should assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance level Electromagnetic environment –...
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Page 22: Technical Information (Smp2 Serial Numbers 6000 And Greater)
TECHNICAL INFORMATION For SMP2 serial number 6000 and greater The Harvest SmartPReP 2 Centrifuge meets the requirements for leakage current and hi-pot testing listed in BS EN 60601-1 and UL 2601-1 standards for Medical Electrical Equipment. (Less than 100µA on model SMP2-100 and SMP2-115) (Less than 500µA on model SMP2-230) -
Page 23: Electrical Specifications
IEC 60601-1-2 Issued: 2007/03/01 Ed: 3.0 Medical Electrical Equipment - Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests Evaluation for Japan requirements. - Page 24 Guidance and Manufacturer’s Declaration- Emissions All ME Equipment and ME Systems Guidance and Manufacturer’s Declaration- Emission The SmartPReP2 is intended for use in the electromagnetic environment specified below. The customer or user of the SmartPReP2 should ensure that it is used in such an environment. Emissions Test Compliance Electromagnetic Environment-Guidance...
- Page 25 Guidance and Manufacturer’s Declaration- Immunity ME Equipment and ME Systems that are NOT Life-Supporting Guidance and Manufacturer’s Declaration- Immunity The SmartPReP2 is intended for use in the electromagnetic 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...
- Page 26 , 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.
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