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User Manual Is Delivered Subject to the Conditions and Restrictions Listed in This Section Important Notice The Sapphire Infusion Pump User Manual is delivered subject to the conditions and restrictions listed in this section. Clinicians, qualified hospital staff, and home users should read the entire User Manual prior to operating the Sapphire pump in order to fully understand the functionality and operating procedures of the pump and its accessories. • Healthcare professionals should not disclose to the patient the pump's security codes, Lock levels, or any other information that may allow the patient access to all programming and operating functions. • Improper programming may cause injury to the patient. • Home users of the Sapphire pump should be instructed by a certified home healthcare provider or clinician on the proper use of this pump. Prescription Notice Federal United States law restricts this device for sale by or on the order of a physician only {21 CFR 801.109(b) (1)}. The Sapphire pump is for use at the direction of, or under the supervision of, licensed physicians and/or licensed healthcare professionals who are trained in the use of the pump and in the administration of blood, medication and parenteral nutrition. The instructions for use presented in this manual should in no way supersede established medical protocol concerning patient care. Copyright, Trademark and Patent Information © 2015, Q Core Medical Ltd. All right reserved. Sapphire and Q Core (with or without logos) are trademarks of Q Core Medical Ltd. The design, pumping mechanism and other features of the Sapphire pump are protected under one or more US and Foreign Patents. 1 Sapphire Infusion Pump User Manual Disclaimer The information in this manual has been carefully examined and is believed to be reliable. No responsibility is assumed for any inadvertent inaccuracies. Q Core Medical Ltd. reserves the right to make changes to any of its products in order to improve reliability, design and performance. The instructions presented in this manual should in no way supersede established medical protocol concerning patient care. The text and drawings herein are for the purposes of illustration and reference only; the specifications on which they are based are subject to change without notice. Warning Use only Q Core Medical Ltd. supplied administration sets and accessories with the Sapphire pump. Use of administration sets other than Q Core Medical Ltd. supplied sets may impair the operation of the pump and the accuracy and flow rate of the infusion, and may generate hazardous fluid pressures which may activate occlusion alarms at unpredictable pressures. Q Core Medical Ltd. warranty on this device will be null and void and Q Core Medical Ltd. will assume no responsibility for incidents which may occur if the product is not used in accordance with product labeling. Refer to Warnings and Safety Precautions on page 22 for a complete list of warnings and cautions. Technical Assistance For technical questions, troubleshooting assistance and reporting of unexpected events, please contact your local agent/distributor. To locate authorized Hospira service centers near you, refer to Authorized Hospira service centers on page 278. You may also contact Q Core Medical Ltd. support via email to the following address: [email protected] 2 This page is left intentionally blank 3 Sapphire Infusion Pump User Manual Contents 1. INTRODUCTION .................................................................10 Product Overview and Indications.................................................................. 10 Dedicated Delivery Mode Configurations.....................................................11 Features ............................................................................................................12 Terms and Abbreviations ................................................................................ 14 Document Conventions.................................................................................. 16 Safety and Compliance Information ............................................................... 16 Symbols and Labeling .....................................................................................17 Compliance and Classification .......................................................................20 Biocompatibility...............................................................................................20 Sterilization.......................................................................................................21 Degree of Protection Against Ingress of Water and Dust............................21 Warnings and Safety Precautions ................................................................... 22 General Warnings and Precautions................................................................22 Proper Use of the Pump..................................................................................25 2. COMPONENTS, ACCESSORIES, AND ADMINISTRATION SETS....................................................30 Unpacking the Pump ...................................................................................... 30 Hardware and Software Components............................................................. 31 Touch Screen....................................................................................................32 Using Pump Accessories................................................................................. 34 Mini Cradle.......................................................................................................34 PCA Lockboxes................................................................................................37 PCA Lockbox 250mL........................................................................................41 PCA/PCEA/PIEB Bolus Handle.......................................................................45 Power Supply ...................................................................................................46 External Battery Pack.......................................................................................47 Multi-Pump Mounting System........................................................................54 Administration Sets .........................................................................................59 4 3. FUNDAMENTAL CONCEPTS AND OPERATIONS ......................62 Working with the Main Display....................................................................... 62 Using the Keypad.............................................................................................62 Overview of Toolbar Function Keys................................................................64 Overview of Icons ............................................................................................65 Selecting Delivery Mode ................................................................................ 68 Enabling Special Features .............................................................................. 70 Setting KVO rate..............................................................................................73 4. GETTING STARTED ............................................................74 Typical Workflow............................................................................................. 74 Turning the Pump On ..................................................................................... 76 Turning the Pump Off......................................................................................76 Connecting the Infusion Container to the Administration Set ....................... 77 Opening the Safety Door ............................................................................... 78 Inserting the Administration Cassette ............................................................ 79 Removing the Administration Cassette .........................................................81 Automatic Priming Using the Pump................................................................ 82 Priming Manually ............................................................................................ 84 5. USING THE DELIVERY MODES.............................................86 Continuous Mode........................................................................................... 86 Infusion Parameters: Continuous Mode ........................................................89 Starting a Continuous Infusion .......................................................................89 Continuous Mode: Mid-infusion Actions.....................................................100 Multi-step Mode ........................................................................................... 114 Infusion Parameters: Multi-step Mode.........................................................115 Starting a Multi-step Infusion........................................................................115 Multi-step Mode: Mid-infusion Actions .......................................................121 Total Parenteral Nutrition (TPN) Mode ......................................................... 123 Infusion Parameters: TPN Mode ..................................................................124 Starting a TPN Infusion..................................................................................125 Intermittent Mode ........................................................................................ 130 Infusion Parameters: Intermittent Mode......................................................131 Starting an Intermittent Infusion...................................................................131
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