Therakos CellEx Photopheresis System Operators Manual Sw 5 Rev B Aug 2018

2797

THERAKOS™ CELLEX™ PHOTOPHERESIS SYSTEM

Operator’s Manual

For Use with Software 5

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2797 Copyright © 2018, Therakos, Inc. All rights reserved. Information and descriptions contained in this manual are the property of Therakos. Written permission from Therakos must be obtained before any information or descriptions from this manual are copied or reproduced. Please direct any written inquiry as follows: In the USA and Canada, Distributed in North America by, Therakos, Inc., a Mallinckrodt company 1425 US Route 206 Bedminster, NJ 07921 USA All additional contact information for Therakos may be found on the last page of this manual. Disclaimer: Photographs and schematic diagrams in this operator’s manual may vary slightly from the actual products in use. Operators will be informed in writing of any manufacturing variances that result in instructional changes and / or performance changes to the instrument or procedural kit.

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CAUTION: All automatic sensor functions, pump rates, anticoagulant delivery ratios and fluid balance estimates are limited to the accuracies of the component parts listed in SECTION 8: SPECIFICATIONS. Failure of the instrument to meet these performance specifications may lead to less than optimal buffy coat collections, blood loss due to clotting or leakage, increased risk of infection, hypovolemia or hypervolemia and / or a failed treatment.

8-MOP® is a registered trademark of Valeant Pharmaceutical International, formally ICN Pharmaceuticals. IrDA™ is a registered trademark of The Infrared Data Association. Tyvek® is a registered trademark of DuPont Corporation. THERAKOS™ UVAR XTS™ is a registered trademark of Therakos, Inc. The devices and methods described in this manual are covered by one or more of the following US patents and their foreign counterparts: 5,569,928; 5,459,322; 5,921,951; 6,069,687; 6,219,584; 6,491,656; 6,495,366; 6,793,643; 7,211,037; 7,186,230

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1470202A_EN-CA

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Technical Bulletins

1470201A_EN-CA

Technical Bulletin CLX #26 Guidance Instructions For Locating Bearings Against Bearing Stops on CELLEX Photopheresis Procedural Kits 1470366AEN_CA

Customer Product Support Guidance instructions for customer reported concern about location of bearing on drive tube or loose bearings. 1.

Refer to Section 4: LOADING THE THERAKOS™ CELLEX™ PHOTOPHERESIS PROCEDURAL KIT for instructions on loading the centrifuge bowl. Note: If, upon removal of the drive tube assembly from its packaging, the bearing is not fully resting against the bearing stop (see Figure 1), the procedural kit may still be used. The bearing fit on the drive tube is dependent upon the drive tube diameter. Upper and lower drive tube diameter manufacturing specifications can result in a looser or tighter fit of the bearing. Please follow the steps below to successfully load a procedural kit with a bearing that is loose or not flush against the bearing stop.

Bearing

Bearing Stop Figure 1

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Page 1 of 4

Issued 2016-10

Technical Bulletin CLX #26 Guidance Instructions For Locating Bearings Against Bearing Stops on CELLEX Photopheresis Procedural Kits 1470366AEN_CA

2.

To proceed, slide the bearing(s) into position to completely rest against the bearing stop. Use one hand to hold the drive tube and the other to slide the bearing (see Figure 2 and 3).

Figure 2

Figure 3

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Page 2 of 4

Issued 2016-10

Technical Bulletin CLX #26 Guidance Instructions For Locating Bearings Against Bearing Stops on CELLEX Photopheresis Procedural Kits 1470366AEN_CA

3.

Confirm the bearing is completely resting against the bearing stop (see Figure 4).

Bearing Bearing Stop Figure 4 4.

Proceed installing the THERAKOS™ CELLEX™ Procedural Kit drive tube assembly into the THERAKOS™ CELLEX™ Instrument centrifuge assembly as instructed in Section 4: LOADING THE THERAKOS™ CELLEX™ PHOTOPHERESIS PROCEDURAL KIT which also includes instructions on loading the centrifuge bowl.

THERAKOS,CELLEX and UVAR XTS are trademarks of a Mallinckrodt Company

Page 3 of 4

Issued 2016-10

Technical Bulletin CLX #26 Guidance Instructions For Locating Bearings Against Bearing Stops on CELLEX Photopheresis Procedural Kits 1470366AEN_CA

THERAKOS,CELLEX and UVAR XTS are trademarks of a Mallinckrodt Company

Page 4 of 4

Issued 2016-10

Technical Bulletin CLX #27 Installation of Pressure Domes on CELLEX Photopheresis Procedural Kits 1470463_RevA_US_UK_CA

Installation of Pressure Domes

Step1. Locate the 3 pressure transducers.

Step 2. Pinch tabs to release green cap.

Step 3. Visually confirm that membrane is present and is fully intact.

Step 4.

a. Remove pressure dome cover.

b. Pinch pressure dome tabs and carefully position on pressure transducer.

c. Release tabs while maintaining contact between pressure dome and pressure transducer. Grasp pressure dome at base and gently rock in direction of tubing to verify it is secure.

Step 5. With downward pressure, gently spread tabs to fully engage pressure dome.

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Do not rock by grasping tabs.

Step 6. Gently verify the pressure dome is seated securely. If not secure repeat steps 4-6.

NOTE: • Ensure to SPREAD TABS and VERIFY pressure dome is secure prior to initiating PRIME sequence. Failure to do so may lead to PRIME TEST failures and longer set up times.

Repeat steps 2–6 for the other two procedural kit pressure domes.

THERAKOS,CELLEX and UVAR XTS are trademarks of a Mallinckrodt Company

Page 1 of 2

Issued 2018-01

Technical Bulletin CLX #27 Installation of Pressure Domes on CELLEX Photopheresis Procedural Kits 1470463_RevA_US_UK_CA

©Therakos

®Trademark of Therakos, Inc. Page 2 of 2

Issued 2016-10

Technical Bulletin CLX #28 Splenectomy as a Contraindication to THERAKOS® Cellex® Photopheresis systems 1470529_Rev1_EN_US_CA

Splenectomy as a Contraindication to THERAKOS® Photopheresis •

THERAKOS® Photopheresis is contraindicated in patients who have had previous splenectomy.

Background CTCL 3, the pivotal study for approval of UVADEX sterile solution, evaluated the use of UVADEX in conjunction with the THERAKOS Photopheresis System (UVAR) in the palliative treatment of the skin manifestations of cutaneous T-cell lymphoma (CTCL). Patients who had splenectomy were excluded from this study. Mallinckrodt has not conducted any studies evaluating the use of THERAKOS Photopheresis systems in patients with prior splenectomy. Therefore, there is no data on file related to the provision of photopheresis in this patient population.

THERAKOS,CELLEX and UVAR XTS are trademarks of a Mallinckrodt Company

Page 1 of 1

Issued 2018-07

Technical Bulletin CLX #29 Caution for Thromboembolic Events for THERAKOS® Photopheresis 1470495_Rev1_US UK CA

Caution for Potential Thromboembolic Events with GvHD Patients Undergoing THERAKOS™ CELLEX™ Photopheresis Treatments Special attention to adequate anticoagulation is advised when treating patients with Graft versus Host Disease (GvHD), a condition associated with an increased risk of thromboembolic events. Thromboembolic events, including pulmonary embolism and deep vein thrombosis, have been reported with the use of the THERAKOS™ CELLEX™ Photopheresis System in the treatment of GvHD, an indication not approved in some countries, including the United States and Canada.

THERAKOS,CELLEX and UVAR XTS are trademarks of a Mallinckrodt Company

Page 1 of 1

Issued 2018-08

Reference Guides

1470201A_EN-CA

THERAKOS™ CELLEX™ Photopheresis System 1470207A_EN-CA

Procedural Kit Installation Guide

For complete instructions, warnings and precautionary information consult the THERAKO™ CELLEX™ Photopheresis System Operator’s

1. Establish “Ready State”. Check operator interface for “zeros”.

2. Insert photoactivation module, remove kit, hang bags, insert pump tubing organizer.

T

R

3. Install drive tube / centrifuge bowl.

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THERAKOS™ CELLEX™ Photopheresis System 1470207A_EN-CA

Procedural Kit Installation Guide

For complete instructions, warnings and precautionary information consult the THERAKO™ CELLEX™ Photopheresis System Operator’s

4. Load pump tubing segments.

5.

Smart Card

Pressure Domes

Spike Fluids

Close Collect Line (RED).

Air Detectors

Hematocrit Cuvette

Clean needle-free injection port.

Connect Return Line and open (BLUE) clamp.

6.

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THERAKOS,CELLEX and UVAR XTS are trademarks of a Mallinckrodt Company

Page 2 of 2

THERAKOS™ CELLEX™ Photopheresis System

1470205A_EN-CA

Reference Guide for Estimating ECV and TBV EXTRACORPOREAL BLOOD VOLUME (ECV) American Association of Blood Banks’ guidelines set a maximum extracorporeal blood volume to be less than or equal to 15% of the patient’s Total Blood Volume. A new calculation of Total Blood Volume is necessary prior to each treatment to estimate the safe extracorporeal blood volume that may be allowed for the patient undergoing treatment. These calculations should be performed using the current weight and current hematocrit (the latter drawn after the last photopheresis treatment and within 48 hours prior to the next photopheresis treatment). Certain medical conditions may warrant an extracorporeal blood volume of less than 15% of Total Blood Volume.

PREDICTING ACTUAL PROCEDURAL KIT EXTRACORPOREAL BLOOD VOLUME

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CAUTION: In some medical conditions, the patient’s hematocrit may change from day to day. Use a hematocrit measured within 48 hours of photopheresis to estimate the THERAKOS™ CELLEX™ Photopheresis Procedural Kit extracorporeal volume during a treatment.

In both DOUBLE NEEDLE and SINGLE NEEDLE modes a minimum amount of whole blood must be processed to prime the Bowl and establish the proper plasma / red blood cell interface. This extracorporeal blood volume increases as the patient’s hematocrit decreases. A blood prime of the Centrifuge Bowl using crossmatched compatible packed red blood cells may be required if the patient’s current weight and hematocrit exceed the safe 10–15% extracorporeal blood volume. Table 1 estimates the average Procedural Kit ECV for each of the following % hematocrits:

% HCT

Estimated ECV DOUBLE NEEDLE

Estimated SINGLE NEEDLE Mode Extracorporeal Volume (ECV) When Return Bag Threshold Value (RBTV) is Set at (XmL): Return Bag Threshold Value = 100

150

200

250

27%

396

441

491

541

591

28%

384

429

479

529

579

29%

372

417

467

517

567

30%

362

407

457

507

557

31%

352

397

447

497

547

32%

343

388

438

488

538

33%

334

379

429

479

529

34%

326

371

421

471

521

35%

319

364

414

464

514

36%

311

356

406

456

506

37%

304

349

399

449

499

38%

298

343

393

443

493

39%

292

337

387

437

487

40%

286

331

381

431

481

41%

280

325

375

425

475

42%

275

320

370

420

470

43%

270

315

365

415

465

44%

265

310

360

410

460

Table 1: Estimated Extracorporeal Volume Relative to % Hematocrit, Access Mode and Return Bag Threshold Value THERAKOS,CELLEX and UVAR XTS are trademarks of a Mallinckrodt Company

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THERAKOS™ CELLEX™ Photopheresis System

1470205A_EN-CA

Reference Guide for Estimating ECV and TBV ESTIMATING THE PATIENT’S TOTAL BLOOD VOLUME The THERAKOS™ CELLEX™ Photopheresis System continuously monitors and displays the volume of fluid movement to and from the patient during a THERAKOS™ Photopheresis treatment. These fluids may be whole blood, anticoagulant, or saline. A negative fluid balance indicates that the patient is undergoing a temporary fluid deficit. A positive fluid balance indicates that the patient has received additional fluids. Generally, a patient will be approximately 350–450 mL fluid positive at the completion of a routine treatment. The American Association of Blood Banks recommends that fluid balance be maintained within ± 10–15% of the patient’s Total Blood Volume (TBV) during any extracorporeal procedure. Fluid Balance Setup Screen

Integrated TBV Calculator Method:

To assist in establishing appropriate fluid balance alarm limits, the THERAKOS™ CELLEX™ Photopheresis System incorporates an integral fluid balance calculator that uses the Nadler formula to estimate the patients Total Blood Volume. The calculator and fluid balance setup screen will automatically display prior to patient connection and will be available after initiation of the treatment via the setup screen. The integrated calculator uses the Nadler formula for computing the patients Total Blood Volume using Gender, Weight and Height as Inputs to the equation below. • (Male) Total Blood Volume = 0.3669 x (height in meters)3 + 0.03219 x weight in kg + 0.6041 • (Female) Total Blood Volume = 0.3561 x (height in meters)3 + 0.03308 x weight in kg + 0.1833 Calculator input limits: • Height 30–244 cm • Weight 25–227 kg Please refer to Calculating and Setting Fluid Balance Limits on Page 5-9 of the THERAKOS™ CELLEX™ Photopheresis Operator’s Manual for specific instructions in using integrated TBV calculator.

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NOTE: Maximum extracorporeal volume for patients weighting less than 30 kg should not exceed 10% of the patient’s Total Blood Volume. Patients that do not meet the safe minimal ECV should only be treated using a blood prime procedure.

Alternate Method to Compute Total Blood Volume (TBV): Total Blood Volume (TBV) in milliliters (mL) can be estimated by multiplying the patient’s weight in kilograms (kg) by the appropriate body build factor predicting blood volume in mL/kg. • Compute the estimated TBV by using the body build table below: • Weight (kg) x Body Build Factor (mL/kg) = TBV (mL) BODY BUILD

MALE

FEMALE

Adult Muscular

80 mL/kg

75 mL/kg

Adult Normal

75 mL/kg

70 mL/kg

Adult Thin

70 mL/kg

65 mL/kg

Adult Obese

65 mL/kg

60 mL/kg

Adolescent Neonate

75–70 mL/kg 100–80 mL/kg

75–70 mL/kg 100–80 mL/kg

Table 2: TBV Body Build Factor Table Once TBV is calculated, you may enter the value into fluid balance setup screen or TBV calculator.

2015-11

THERAKOS,CELLEX and UVAR XTS are trademarks of a Mallinckrodt Company

Page 2 of 2

THERAKOS™ CELLEX™ Photopheresis System

1470206A_EN-CA

Example Flow Sheet Date:

Treatment No.:

CELLEX® Serial Number:

Name:

Pt. ID#

Instrument Hours: Lamp Hours:

Draw Date:

ON LY

Diagnosis: WBC:

RBC Morphology:

HCT:

r Normal

PLT:

r Abnormal

Other Labs: Access: Estimated TOTAL BLOOD VOLUME (TBV):

Lot # Methoxsalen:

Exp:

Lot # Needle:

Exp:

Lot # Needle:

Exp:

=

(Body build factor mL/kg)

(TBV mL)

mL

(TBV x 0.15)

mL

FLUID BALANCE Limits: ±

mL

mL

(when Return Bag Threshold =

mL)

LE Resp:

Treatment Start Time:

Pulse:

Temp:

Treatment End Time:

YES

NO

SINGLE NEEDLE

DOUBLE NEEDLE

EX AM P

mL/min Changed Pressure Settings to:

Blood Processed

BP

Pulse

Final Treatment Volume:

Resp

Collect Rate

Return Rate

A/C mL

x 0.017 =

Methoxsalen dose = Fluid Balance =

Comments

mg Photoactivation Time:

units/500 mL saline x

A/C mL =

units

Patient advised to wear UV glasses/sunscreen for 24 hours after each ECP treatment?

YES

NO

Smart Card returned to Therakos, Inc. for analysis?

YES

NO

Signature:

Init

TIME:

mL x 20 mcg/mL =

Heparin:

Saline mL

mL Methoxsalen

Injected by:

Initials:

mL

mL/min A/C Ratio:

Return Rate Limit Time

Exp:

BP:

mL

Collect Rate Limit:

Lot # Heparin:

POST-TREATMENT

Is the patient suitable for treatment? WHOLE BLOOD PROCESSED Target:

Exp:

to

PRE-TREATMENT Temp:

Exp:

(TBV x 0.1)

Estimated SINGLE NEEDLE ECV:

Pulse:

Lot # Saline:

Lot # Saline:

(Wt. in lbs. ÷ 2.2 = Wt. in kg)

Estimated DOUBLE NEEDLE ECV:

Resp:

Exp:

x

Safe EXTRACORPOREAL RANGE (ECV):

BP:

Lot # Kit:

Initials:

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Signature:

Page 1 of 2

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THERAKOS™ CELLEX™ Photopheresis System

1470206A_EN-CA

Example Flow Sheet

ON LY

ECP Operator Notes:

EX AM P

Physician Notes:

Physician Signature

Date

LE

ECP Operator Signature

Date

Disclaimer: This document has been created as an educational tool for operator’s training on THERAKOS™ CELLEX™ Photopheresis System. Therakos shall not be responsible for any loss or damage arising from the use of or reliance on this information.

2015-11

©Therakos, Inc. 2015 ®Registered Trademark of Therakos,Company Inc. THERAKOS,CELLEX and UVAR XTS are trademarks of a Mallinckrodt

Page Page 2 of2 2

1470203A_EN-CA

THERAKOS™ CELLEX™ Photopheresis System BLOOD PRIME REFERENCE: DOUBLE NEEDLE Mode

BEFORE YOU BEGIN: Abbreviations: TBV = Total Blood Volume (mL) ECV = Extracorporeal Volume (mL) pRBC = packed Red Blood Cells (donor unit) A/C Ratio = Drops of Blood/Drops of Anticoagulant BOS = Bowl Optic Sensor Reading WBP = Whole Blood Processed (mL) SN mode = SINGLE NEEDLE mode DN mode = DOUBLE NEEDLE mode KVO = Keep Vein Open (anticoagulant or saline drip at 10 mL/hour) Additional supplies: A. One donor pRBC unit, minimum volume = 250 mL, minimum hematocrit of 50%. pRBCs should be as fresh as possible (≤14 days). Recommend one additional unit available as backup. B. One blood administration filter set with two-way flow through filter. NOTE: Y-Type filter set allows wetting filter with saline if desired. C. One high flow stopcock (with two female luers and one male luer). ¾¾Determine if blood prime is necessary: a. Estimate the patient’s total blood volume. See Section 10 of THERAKOS™ CELLEX™ Photopheresis System Operator’s Manual for more information. b. Using the patient’s hematocrit percent (within 48 hours of treatment) refer to “Estimated Extracorporeal Volume” table in Section 10 of the THERAKOS™ CELLEX™ Photopheresis System Operator’s Manual to estimate the expected ECV during the treatment. Maximum extracorporeal volume for patients weighing less than 30 kg should not exceed 10% of the patient’s Total Blood Volume. Patients that do not meet the safe minimal ECV should only be treated using a blood prime procedure. c. Also consider the clinical condition of the patient at time of treatment to determine any additional reason for priming the extracorporeal circuit with blood, such as the patient’s circulating RBC volume, or a low resting blood pressure, etc. d. Document above calculations on flow sheet. ¾¾The patient will be isovolemic during DRAWING/RETURNING when DN mode access is used and the COLLECT and RETURN flow rates are identical. The patient will remain isovolemic during BUFFY COAT if the donor pRBC unit is used to displace the buffy coat and the return flow rate is 0 mL/min. On average, following the instructions below, the patient will become approximately 170 mL fluid positive once the treated leukocytes are reinfused and rinseback is performed. Confirm that the patient is able to tolerate this positive fluid shift. ¾¾The clinician must establish the patient WBP target and prescribe the appropriate dose of anticoagulant. REMINDER: For patients < 40 kg use 150–250 Units of heparin/kg body weight/500 mL 0.9% Normal saline per treatment. See Page 2-8, Anticoagulation, of the THERAKOS™ CELLEX™ Photopheresis System Operator’s Manual, for more information. ¾¾The operator must confirm the proper anticoagulant for the patient before kit installation and PRIME. ¾¾Confirm that a double lumen access is available and it will allow COLLECT and RETURN flow rates of at least 15 mL/min. 99Confirm patency of patient’s access before continuing. ¾¾Use aseptic technique when making all connections and disconnections. ¾¾Avoid blood leaks by closing all clamps and verifying the position of the stopcock prior to connecting or disconnecting lines. ¾¾Confirm all lines are void of air before each connection is made.

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2015-09