SpectraOptiaOpsManual.book Page i Thursday, May 17, 2018 11:24 AM Spectra Optia® Apheresis System Operator’s Manual Part No. 777379-124 Reorder No. 703261-001 2018-04 SpectraOptiaOpsManual.book Page ii Thursday, May 17, 2018 11:24 AM ©2018 Terumo BCT, Inc. Terumo BCT is a registered trademark of Terumo Corporation. Seal Safe is a trademark of Terumo BCT, Inc. Spectra Optia is a registered trademark of Terumo BCT, Inc. This product may be covered by one or more patents or pending patent applications. See TERUMOBCT.COM/patents for details. Terumo BCT, Inc. 10811 W. Collins Avenue Lakewood, Colorado 80215 USA USA Phone: +1.877.339.4228 Phone: +1.303.231.4357 USA Fax: +1.866.715.6768 Fax: +1.303.542.5215 Terumo BCT Europe N.V. Ikaroslaan 41 1930 Zaventem, Belgium Phone: +32.2.715.05.90 Fax: +32.2.721.07.70 TERUMOBCT.COM SpectraOptiaOpsManual.book Page i Thursday, May 17, 2018 11:24 AM Contents Chapter 1: Preface . 1 About This Operator’s Manual . 2 Conventions Used in this Manual . 2 Numbered Steps . 2 Touch screen buttons . .2 Bullets . 2 Warnings, Cautions, and Notes . 2 Spectra Optia Apheresis System . 3 Intended Use . 3 Contraindications for Use . 3 Warnings and Cautions for Use . 3 Warnings for Use . 3 System warnings . .3 Service warnings . .4 Electrical warnings . .4 General procedural warnings . .4 Exchange procedure warnings . .6 Collection and depletion procedure warnings . .7 General tubing set warnings . .7 Accessory set warnings . .8 Fluid warnings . .8 Seal Safe system warnings . .8 Cautions for Use . 9 System cautions . .9 Service cautions . .10 General procedural cautions . .10 Collection and depletion procedure cautions . .11 General tubing set cautions . .12 Exchange Set cautions . .12 Collection Set cautions . .13 IDL Set cautions . .13 Fluid cautions . .13 Seal Safe system cautions . .14 Service Information . 15 Special Use of Additional Equipment and Devices During Apheresis Procedures . 15 Fluids Administered During Apheresis Procedures. 16 Saline Solution . 16 Anticoagulant . 16 ACD-A . .16 Hydroxyethyl Starch (HES) . .16 Spectra Optia Apheresis System Operator’s Manual i SpectraOptiaOpsManual.book Page ii Thursday, May 17, 2018 11:24 AM Contents Replacement Fluids . 16 Adverse Events of Apheresis Procedures . 17 Reactions to Blood Products Transfused During Procedures . 18 Disposal of Infectious and Non-Infectious Waste . 18 Return of Used Product . 18 Chapter 2: Introduction . 19 Spectra Optia System Description . 20 Spectra Optia System Components . 21 Front Panel . 23 Pumps . 23 Valves . 24 Sensors and detectors . 24 Return line air detector . ..