Terumo Harvest SmartPReP 2 Operating manual

4531200 / 1042

Operators and Service Manual

SmartPReP® 2 Centrifuge System

For Platelet, Bone Marrow

And Adipose Tissue Concentration

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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

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

LIMITED WARRANTY .................................................................................................................. 17

TECHNICAL INFORMATION (SMP2 serial numbers 0101-5999) ................................................ 18

PHYSICAL SPECIFICATIONS .................................................................................................... 18

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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

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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:” indicate information or procedures that if not followed

correctly can cause improper results, damage to the equipment, injury to personnel, or serious patient

harm.

INTENDED USE

The SmartPReP 2 System is designed to be used for the safe and rapid preparation of autologous

platelet-rich-plasma (PRP) from a small sample of blood at the patient’s point of care. The PRP can be

mixed with autograft or allograft bone grafting materials prior to application to an orthopedic surgical

site as deemed necessary by the clinical use requirements.

The SmartPReP2 System is intended to be used in the 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 concentrating adipose tissue

harvested with a legally marketed lipoplasty system. The AdiPrep™ Adipose Transfer System is

intended for use in the following surgical specialties when the concentration of harvested adipose

tissue is desired: Arthroscopic Surgery, Gastrointestinal Surgery, General surgery, Gynecological

Surgery, Laparoscopic Surgery, Neurosurgery, Plastic and Reconstructive Surgery, Thoracic Surgery, and

Urological Surgery.

SYSTEM CONCEPT

The SmartPReP 2 System consists of a microprocessor-controlled, centrifuge with automated decanting

capability using a dual chamber sterile processing disposable. The system technology provides a

reproducible process for concentrating desired cells without user interaction beyond loading and starting

the centrifuge.

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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

The control panel is simple and intuitive, providing only three

controls: LID, START and STOP

The (LCD) liquid crystal display indicates the time remaining until the process 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 also illuminated whenever

the STOP keypad is pressed during a process cycle.

LID OPEN Illuminates when LID is open or improperly closed. When this LED is illuminated, the

centrifuge is prevented from operating.

IMBALANCE Illuminates when the control system senses an imbalance in the rotor. If this condition

occurs, the centrifuge is brought to a stop and cannot be restarted until the imbalance

condition is corrected.

TIMING Displays the time remaining in the process cycle.

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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

modified by the user, thus ensuring reproducible results

The control panel is simple and intuitive, providing only four controls:

LID, PRP (START), BMAC (START) and STOP.

The (LCD) liquid crystal display indicates the time remaining until the process is complete.

POWER

INTERRUPTED

LID OPEN

IMBALANCE

DONE

TIMING

LID

STOP

PRP BMAC

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 also illuminated whenever

the STOP keypad is pressed during a process cycle.

LID OPEN Illuminates when LID is open or improperly closed. When this LED is illuminated, the

centrifuge is prevented from operating.

IMBALANCE Illuminates when the control system senses an imbalance in the rotor. If this condition

occurs, the centrifuge is brought to a stop and cannot be restarted until the imbalance

condition is corrected.

TIMING Displays the time remaining in the process cycle.

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SMP2 Control Panels

Serial Number 0101- 5999

Serial Number 6000 >

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). Please refer to the Instructions for Use provided with each of the kits listed below 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 opposing rotor

AA-1 AdiPrep Adapter

Used with AATS Kits

2- AA-1 are required to process

BW-ADI AdiPrep Balance Weight

Used with AA-1 Adapter and AATS Kits

APC-120 & BMAC-120 kits do not require balance weights

BWAT-20 & BWAT-60 balance weights are avialable for international use with AT Pro Kits

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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.

2. Install line cord and plug into the appropriate mains voltage.

3. Visually inspect the display panel and verify the Green “Power” light and the yellow “Interrupted”

light are illuminated. Press the LID keypad and open the lid. The “Interrupted” light should go out

and the yellow “Lid Open” light should be illuminated.

4. Remove all shipping material. Verify that the rotor assembly is correctly installed and secure on the

motor shaft.

5. Remove the balance weights from the rotor assembly and set aside.

6. Commence a test run by closing the lid firmly; verify that only the POWER light is illuminated; press

START, PRP or BMAC. The centrifuge should start and the automated cycle should be complete in

approximately 14 minutes. At the end of the cycle, the “DONE” indicator light should be illuminated

and audible tone sounds, indicating the rotor has come to a complete stop 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 (swinging buckets). The processing

disposable(s) should fit snuggly but should not require excessive force to install. If resistance is

experienced, check for obstructions in the rotor and/or debris on the process disposable or

proper orientation of the process disposable to the swinging bucket.

INSTRUCTIONS FOR USE

Once the hardware is set up and has successfully completed a test run the unit is ready to operate. Any

one of the following five scenarios will automatically balance the unit if the Process Disposables (PD) are

filled properly. (Refer to the kit’s Instructions for Use for detailed filling instructions). The standard

centrifuge is equipped with a two place rotor. An optional four place rotor is available through special

order.

CAUTION:Do not process a combination of 20, 30 and 60mL APC or BMAC PD’s in the same cycle as they

will not balance.

CAUTION:Do not process APC or BMAC PD’s with the AdiPrep PD in the same cycle as they will not

balance.

CAUTION: Always have another PD or BW of equal weight in the trunnion opposing the PD to ensure

balance.

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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 –Same as above for one or two PD’s

Scenario 4 –One properly filled equal volume PD in each swinging trunnion. (4 total)

Scenario 5 –One properly filled PD in three of the trunnion and one balance weight (of equal

weight) in the fourth trunnion bucket. (3 total)

CAUTION: If the unit is not loaded with one of the five scenarios listed above the unit will IMBALANCE

and not continue.

CAUTION: The process disposables are single patient use only. Do not re-use or re-sterilize. Reuse of

disposable products 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.

CAUTION: Be sure the PD is properly seated as shown

3. Close the lid

4. Press the START button in SMP2 with serial numbers 0101-5999: For SMP2 Systems with serial

numbers 6000> press the blue PRP button for platelet concentrate or orange BMAC button for

bone marrow concentrate.

5. The TIMING window will display the remaining time till the end of the cycle. When the cycle is

complete the DONE led will flash and an audible alarm will sound.

6. Press the LID button and remove the PDs.

7. Refer to the Instructions for Use accompanying the Processing Kits.

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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

with the white dots aligned as shown.

Be sure the adapter is properly seated

as shown below

Correct Incorrect

To process adipose tissue in the SMP2 System:

Scenario 1 - Install one AdiPrep process disposable

into one AA-1 Adapter and the BW-ADI AdiPrep

Balance Weight into the opposing adapter, as

shown below.

Scenario 2 - Install two (2) AdiPrep process disposables, one in

each AA-1 Adapter, as shown below.

1. Close the 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 septicemia for patients who have taken aspirin, or other medications that alter platelet function, within

3 days prior to surgery, or patients with disorders associated with platelet dysfunction.

WARNINGS

Federal law (USA) restricts this device to sale by, or on the order of a physician. The physician is solely

responsible for the use of this device.

Safe and effective use of this device requires proper set-up and operation by trained personnel.

This device should not be used in the presence of flammable agents.

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