Sapphire User Manual Rev 16.20

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.

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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.

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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 © 2023, Eitan Medical Ltd. All right reserved. Sapphire and Eitan Medical are trademarks of Eitan Medical Ltd. The design, pumping mechanism and other features of the Sapphire pump are protected under one or more US and Foreign Patents.

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Disclaimer The information in this manual has been carefully examined and is believed to be reliable. No responsibility is assumed for any inadvertent inaccuracies. Eitan 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 Eitan Medical Ltd. supplied administration sets and accessories with the Sapphire pump. Use of administration sets other than Eitan 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. Alternatively, administration sets from different manufacturers that are regulatory cleared and labeled for use with the Sapphire infusion system, can be used as well. The list of regulatory cleared sets needs to be obtained from the official manufacturer’s publication such as manufacturer’s website, catalog or any other formally published document. Using anything other than administration sets regulatory cleared and labeled for use with Sapphire infusion system, may result in operation that is not within the constraints and parameters of the device. Eitan Medical Ltd. warranty on this device will be null and void and Eitan 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 25 for a complete list of warnings and cautions.

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Sapphire Infusion Pump User Manual

Technical Assistance For technical questions, troubleshooting assistance and reporting of unexpected events, please contact your local agent/distributor, and refer to page 332. You may also contact Eitan Medical Ltd. support via email to the following address: [email protected]

Meaning of the CE Mark Symbol The symbol represents adherence to the Medical Device Regulation 2017/745 of the European Communities concerning medical devices. The electromagnetic compatibility (EMC) requirements are part of the General Safety and Performance Requirements of the Medical Device Regulation.

Serious Incident Reporting Any serious incident that has occurred in relation to the device should be reported to [email protected] and the local competent authority.

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Sapphire Infusion Pump User Manual

Contents 1. INTRODUCTION ...10 Product Overview and Indications ... 10 Clinical Benefits...11 Contraindications...11 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 ...23 Biocompatibility ...24 Sterilization ...24 Degree of Protection Against Ingress of Water and Dust ...24 Warnings and Safety Precautions ... 25 General Warnings and Precautions ...25 Proper Use of the Pump ...31

2. COMPONENTS, ACCESSORIES, AND ADMINISTRATION SETS ...38 Unpacking the Pump... 38 Hardware and Software Components ... 39 Touch Screen ...40 Using Pump Accessories ... 42 Mini Cradle ...42 PCA Lockboxes ...46 PCA Lockbox 250mL...50 PCA/PCEA/PIEB Bolus Handle ...55 4

Sapphire Connect (Version 1.0)...56 Power Supply...79 Integrated Power Supply...81 USB-C Power Supply (Sapphire Connect power supply)...82 External Battery Pack ...84 Multi-Pump Mounting System ...91 Administration Sets...96

3. FUNDAMENTAL CONCEPTS AND OPERATIONS ...98 Working with the Main Display ... 98 Using the Keypad...98 Overview of Toolbar Function Keys...100 Overview of Icons...101 Selecting Delivery Mode... 104 Enabling Special Features ... 106 Setting KVO rate ...110

4. GETTING STARTED...112 Typical Workflow ... 112 Turning the Pump On... 114 Turning the Pump Off ...114 Connecting the Infusion Container to the Administration Set ... 115 Opening the Safety Door... 116 Inserting the Administration Cassette ... 117 Removing the Administration Cassette ...119 Automatic Priming Using the Pump ... 120 Priming Manually... 123

5. USING THE DELIVERY MODES ...126 Continuous Mode ... 126 Infusion Parameters: Continuous Mode ...129 Starting a Continuous Infusion ...129 5

Sapphire Infusion Pump User Manual

Continuous Mode: Mid-infusion Actions... 141 Multi-step Mode ... 156 Infusion Parameters: Multi-step Mode ... 157 Starting a Multi-step Infusion ... 157 Multi-step Mode: Mid-infusion Actions... 163 Total Parenteral Nutrition (TPN) Mode ... 165 Infusion Parameters: TPN Mode ... 166 Starting a TPN Infusion ... 167 Intermittent Mode ... 172 Infusion Parameters: Intermittent Mode... 173 Starting an Intermittent Infusion ... 173 Intermittent Mode: Mid-infusion Actions ... 180 Patient Controlled Analgesia (PCA) Mode ... 182 Infusion Parameters: PCA Mode ... 183 Starting a PCA Infusion ... 184 PCA Mode: Mid-infusion Actions... 190 Epidural Mode ... 193 Patient Controlled Epidural Analgesia (PCEA) Mode ... 194 Epidural Intermittent Mode ... 205

6. BASIC INFUSION OPERATIONS ... 220 Starting New Infusions: Shortcuts... 220 Repeating Last Infusion... 220 Using a PreSet Program ... 222 Resuming Infusions After Pump Shutdown ... 223 Mid-infusion Actions ... 224 Pausing Infusions ... 224 Aborting Infusions ... 225 Locking the Screen ... 226 Activating Patient Lockout... 227 Ending Infusion ... 227

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7. OPTIONS MENU: CONFIGURING, VIEWING AND TESTING ...230 Main Options: Overview ... 230 Setting Delivery Mode ... 231 Managing Configuration Settings ... 232 Managing Alarm Settings...232 Configuring Audio Settings ...235 Configuring General Settings ...236 Defining Regional Parameters ...240 Testing System Function...242 View Menu ...243 Using Special Mode Options ... 251 PCA Options Menu...251 Epidural Mode Options Menu...252

8. USING ADVANCED FEATURES ...254 Managing Authorization Levels... 254 Setting Authorization Lock Levels ...256 Password Re-entry... 257 Creating and Editing PreSet Programs ... 258 Using the Set Delay Feature... 261 Using the New Patient Feature ... 265 Monitoring the Accumulated Volume Infused (Shift's Total) ... 266 Viewing Accumulated VI...266 Clearing Accumulated VI...267

9. DRUG LIBRARY...268 Overview ... 268 Clinical Care Area (CCA) ... 269 Changing a CCA ...269 Programming a New Infusion with the Drug Library ... 273 Drug Name ...273 7

Sapphire Infusion Pump User Manual

Drugs List ... 273 Drug Profiles ... 274 Soft Limit... 275 Update a New Drug Library Version ... 276

10. ALARMS AND TROUBLESHOOTING ... 278 Alarms Overview... 278 Error – Level 1, High Priority Alarms ... 279 Alarm – Level 2 High Priority Alarms ... 280 Messages – Level 3, Low Priority Alarms ... 283 Troubleshooting... 285

11. MAINTENANCE AND STORAGE ... 292 Cleaning and Disinfecting the Pump ... 292 Cleaning and Disinfection Procedure ... 294 Reprocessing the pump when used by a single patient multiple times ... 296 Cleaning Sapphire Connect and Electric Connectors of Sapphire Accessories ... 297 Preventive Maintenance ... 300 Routine Inspection and Maintenance Tasks ... 300 Alarm Testing ... 301 Certification... 302 Battery Care Information ... 303 Battery Classification ... 304 Battery Safety Information ... 304 Charging the Battery ... 306 Battery Maintenance ... 307 Transport and Storage ... 307

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12. TECHNICAL SPECIFICATIONS ...308 Pump Accuracy ... 308 Tiered Flow Rate Accuracy Specifications ...309 Start-up and Trumpet Graphs ...311 Pump Specifications ... 316 Average Bolus Volume After Occlusion ... 318 Environmental Specifications ... 319 Operating Conditions...319 Environmental Conditions for Transport and Storage ...319 Electromagnetic Compatibility Statement ... 321 Electromagnetic Emission ...321 Electromagnetic Immunity ...321

13. LIMITED WARRANTY ...330

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Sapphire Infusion Pump User Manual

Chapter 1: Introduction The following sections describe the functions and features of the Sapphire Infusion Pump, and provide a summary of safety and regulatory information: Product Overview and Indications ... 10 Terms and Abbreviations ... 14 Document Conventions ... 16 Safety and Compliance Information ... 16 Warnings and Safety Precautions ... 25

Product Overview and Indications The Sapphire Infusion Pump is intended for controlled delivery through intravascular, subcutaneous, intra-arterial and epidural routes. The pump is designed to deliver saline, Total Parenteral Nutrition (TPN), lipids, IV medication, epidural medication, blood and blood products. The Sapphire Infusion Pump includes the following infusion modes for all intended uses: Continuous, Intermittent, TPN, PCA, Multi-step, and Epidural. The pump is intended to be used by both licensed health care professionals and lay users. The pump is intended to be used in the following environments: clinical, ambulatory, pre-hospital, ground transportation and home. The dedicated Eitan Medical Sapphire administration sets for the Sapphire Infusion Pump are intended for single-patient use and single-use only. This user manual supports the use of Sapphire software version r16.20. Verify that the software version that appears on the Sapphire turn-on screen is r16.20. The version number can be viewed from View system as well (for more information, refer to View Menu on page 243).

Introduction

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Clinical Benefits The pump offers significant advantages over manual administration of fluids, including the ability to deliver fluids in very small volumes, and the ability to deliver fluids at precisely programmed rates or automated intervals, thus increasing patient safety. These and other pump features result in the following benefits:

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Consistent medication flow rates within a stated accuracy range Reduction of medication treatment errors Simplification of treatment profiles (delivery modes)

Contraindications The pump has no contraindications.

Dedicated Delivery Mode Configurations To promote safety and convenience of use in different environments, the Sapphire Infusion Pump can be preconfigured to support only certain delivery modes. The different types of configurations available on various pump types, are described in the following table. Pump Type Multi-therapy

Delivery Modes Supported 1 or more of the following:

• Continuous • Intermittent • TPN • PCA • Multi-step • Epidural Epidural

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• PCEA • Intermittent Epidural Sapphire Infusion Pump User Manual

Each delivery mode is assigned a unique color that appears on the Indicators Bar, helping users to easily differentiate between the different modes (Figure 3.1 on page 105).

Features The features of the Sapphire Infusion Pump are designed to simplify treatment and ensure patient safety.

Treatment-Related Features

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Single platform device: The delivery mode of the pump can be changed, according to the required type of infusion.

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Priming alternatives: Both manual priming (by gravity) and automatic priming (using the pump) are available.

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Quick infusion titration (in most delivery modes): Modification options allow updating of infusion parameters without stopping the infusion.

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Delayed Infusion: Allows users to program an infusion in advance, and set it to Standby for an unlimited time period, or to set it for a defined Delayed Period.

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Repeat Last Infusion: Automatically saves the parameters of the last infusion, and allows a quick-start infusion using these parameters.

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Resume Infusion After Pump Shut Down: Allows resuming an infusion after the pump has been shut down from a running or paused infusion.

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PreSet Programs: Allows saving the infusion parameters of commonly used protocols, and allows a quick-start infusion using these parameters.

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Piggyback (Continuous delivery mode only): Provides the ability to add a Secondary line to a running continuous infusion, without re-entering infusion parameters for the Primary line.

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Flexible programming features (excluding TPN mode): • Infusions can be programmed in a variety of dose rate units, including the following, per different time units: mL, mg, mcg, units, mUnits, Million Units, gram, nanogram, mmol, mEq.

Introduction

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• Infusion rate can be programmed as a weight based infusion (patient weight can range from 0.1- 500 Kg).

• PIEB – epidural infusion can support the combination of programmed intermittent doses with patient controlled boluses.

Safety-Related Features

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Lock Screen: Avoids inadvertently activating screen functions by locking the screen when the infusion is running.

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Patient Lockout: Prevents unauthorized tampering with the pump by locking pump functions. Password entry is required to reactivate the screen. This option can be configured to automatically activate once an infusion begins.

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Authorization lock level: Allows access to only those pump functions for which the user has authorization. Authorization levels (Low, Medium, High, Technician) are password-controlled.

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Range parameter safety check: Prevents entering infusion parameters that are outside of a precalculated safety range. The permitted ranges vary according to the parameters already entered by the user, or by the limits defined in the Drug Library, if one is installed on the pump.

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Easy alarm troubleshooting: Alarm screens display specific instructions about how to manage the alarm or resolve the problem.

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Drug Library: Enables safer practice according to clinical care area. Programming is done with drug specific name, profile, hard limits and recommended (soft) limits.

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Sapphire Infusion Pump User Manual

Terms and Abbreviations The following table defines common terms and abbreviations used in this manual.

Term/Abbreviation

Meaning

AFFV

Anti-Free-Flow-Valve

AC/DC

Alternating Current / Direct Current

Accum.

Accumulated

CCA

Clinical Care Area

CW

Continuous Wave

DFU

Directions for Use

EBP

External Battery Pack

ECG

Electrocardiogram

Eitan Medical Sapphire administration set

Sapphire administration set

EMC

Electromagnetic compatibility

EMI

Electromagnetic interference

Epi. Int

Epidural Intermittent

h

Hour

Kg

Kilograms

KVO

Keep Vein Open

mcg

Micrograms

mEq

Milliequivalents

min

Minutes

mg

Milligrams

mL

Milliliters

mmol

Millimoles

Mounting System

Sapphire Multi-Pump Mounting System

MRI

Magnetic Resonance Imaging

Introduction

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Term/Abbreviation

Meaning

mUnits

Milliunits

M Units

Million Units

nanog

Nanograms

Occ.

Occlusion

PAV

Pressure Activated Valve

PC

Personal Computer

PCA

Patient Controlled Analgesia

PCEA

Patient Controlled Epidural Analgesia

PIEB

Programmed Intermittent Epidural Bolus

Prim.

Primary

RFID

Radio Frequency Identification

Sec.

Secondary

TPN

Total Parenteral Nutrition

VI

Volume Infused

VTBI

Volume To Be Infused

Eitan Medical

Eitan Medical Ltd.

Sapphire pump

Eitan Medical Sapphire infusion pump family

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Sapphire Infusion Pump User Manual

Document Conventions The following messages in this manual prompt readers to pay special attention to specific points: Warnings indicate instructions for serious adverse reactions and potential safety hazards which, if not followed, may result in personal injury.

Cautions indicate instructions which, if not followed, may result in damage to the equipment or to the quality of treatment.

Notes provide additional information to help obtain optimal equipment performance.

The parameters ranges described in this manual reflect their factory default settings. These ranges may be configured by an authorized technician.

Safety and Compliance Information The following section presents important labeling, safety and compliance information:

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Symbols and Labeling on page 17 Compliance and Classification on page 23 Biocompatibility on page 24 Sterilization on page 24 Degree of Protection Against Ingress of Water and Dust on page 24

Introduction

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Symbols and Labeling The following table describes the labels and symbols that appear on the Sapphire pumps and their components, and identifies their locations on the equipment. Symbol

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Description

Location

Serial number.

Back of the pump casing, front of Sapphire Connect, all accessories, product box and on the back of the mini cradle.

CE certification mark.

Back of the pump casing, on the back of the Sapphire Connect, on the back of the mini cradle, EBP, PCA Lockboxes 100, 250 and 500mL, and Mounting System.

Medical Device

Back of Sapphire Connect, Sapphire Connect product box.

Catalog Number.

Back of the pump casing, front of Sapphire Connect, all accessories, product box.

Authorized representative in the European Community.

Back of the Sapphire Connect, Sapphire Connect product box.

Batch code.

Inside casing of the mini cradle, EBP, PCA Lockboxes 100, 250 and 500mL, and Mounting System.

Sapphire Infusion Pump User Manual

Symbol

Introduction

Description

Location

MR Unsafe (Do not use in MR environment).

Back of the Sapphire Connect.

MR Unsafe (Do not use in MR environment).

Back of the pump casing.

Caution: Consult accompanying documents for safety instructions (service to be performed by qualified technician; consult Service Manual before removing cover).

Back of the pump casing cover, EBP, on the back of the mini cradle, and Mounting System.

Storage temperature range.

Shipping package.

Storage humidity range.

Shipping package.

Storage atmospheric pressure range.

Shipping package.

Consult instructions for use.

EBP, on the back of the mini cradle, and PCA Lockbox 500mL.

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