Sapphire R15 Multi-Therapy and Dedicated Infusion Pumps User Manual sw r15 May 2019

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. 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. The use of Administration sets manufactured by ICU Medical is approved for sale through March, 2023. 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.

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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 290. You may also contact Q Core Medical Ltd. support via email to the following address: [email protected]

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Contents 1. INTRODUCTION ...10 Product Overview and Indications ... 10 Dedicated Delivery Mode Configurations...11 Features ...11 Terms and Abbreviations... 14 Document Conventions ... 16 Safety and Compliance Information... 16 Symbols and Labeling ...17 Compliance and Classification ...20 Biocompatibility ...21 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 ...26

2. COMPONENTS, ACCESSORIES, AND ADMINISTRATION SETS ...32

Unpacking the Pump... 32 Hardware and Software Components ... 33 Touch Screen ...34 Using Pump Accessories ... 36 Mini Cradle ...36 PCA Lockboxes ...40 PCA Lockbox 250mL...44 PCA/PCEA/PIEB Bolus Handle ...48 Power Supply...49 Integrated Power Supply...49 4

External Battery Pack ...51 Multi-Pump Mounting System ...58 Administration Sets...63

3. FUNDAMENTAL CONCEPTS AND OPERATIONS ...68 Working with the Main Display ... 68 Using the Keypad...68 Overview of Toolbar Function Keys...70 Overview of Icons...71 Selecting Delivery Mode... 74 Enabling Special Features ... 76 Setting KVO rate ...80

4. GETTING STARTED...82 Typical Workflow ... 82 Turning the Pump On... 84 Turning the Pump Off ...84 Connecting the Infusion Container to the Administration Set ... 85 Opening the Safety Door... 86 Inserting the Administration Cassette ... 87 Removing the Administration Cassette ...89 Automatic Priming Using the Pump ... 90 Priming Manually... 92

5. USING THE DELIVERY MODES ...94 Continuous Mode ... 94 Infusion Parameters: Continuous Mode ...97 Starting a Continuous Infusion ...97 Continuous Mode: Mid-infusion Actions ...109 Multi-step Mode... 123 Infusion Parameters: Multi-step Mode...124 Starting a Multi-step Infusion...124 5

Sapphire Infusion Pump User Manual

Multi-step Mode: Mid-infusion Actions... 130 Total Parenteral Nutrition (TPN) Mode ... 132 Infusion Parameters: TPN Mode ... 133 Starting a TPN Infusion ... 134 Intermittent Mode ... 139 Infusion Parameters: Intermittent Mode... 140 Starting an Intermittent Infusion ... 140 Intermittent Mode: Mid-infusion Actions ... 147 Patient Controlled Analgesia (PCA) Mode ... 149 Infusion Parameters: PCA Mode ... 150 Starting a PCA Infusion ... 151 PCA Mode: Mid-infusion Actions... 157 Epidural Mode ... 160 Patient Controlled Epidural Analgesia (PCEA) Mode ... 161 Epidural Intermittent Mode ... 172

6. BASIC INFUSION OPERATIONS ... 188 Starting New Infusions: Shortcuts... 188 Repeating Last Infusion... 188 Using a PreSet Program ... 190 Resuming Infusions After Pump Shutdown ... 191 Mid-infusion Actions ... 192 Pausing Infusions ... 192 Aborting Infusions ... 193 Locking the Screen ... 194 Activating Patient Lockout... 195 Ending Infusion ... 195

7. OPTIONS MENU: CONFIGURING, VIEWING AND TESTING ... 198 Main Options: Overview... 198 Setting Delivery Mode... 199 6

Managing Configuration Settings ... 200 Managing Alarm Settings...200 Configuring Audio Settings ...203 Configuring General Settings ...204 Defining Regional Parameters ...208 Testing System Function...210 View Menu ...211 Using Special Mode Options ... 218 PCA Options Menu...218 Epidural Mode Options Menu...219

8. USING ADVANCED FEATURES ...220 Managing Authorization Levels... 220 Setting Authorization Lock Levels ...222 Password Re-entry... 223 Creating and Editing PreSet Programs ... 224 Using the Set Delay Feature... 227 Using the New Patient Feature ... 231 Monitoring the Accumulated Volume Infused (Shift's Total) ... 232 Viewing Accumulated VI...232 Clearing Accumulated VI...233

9. DRUG LIBRARY...234 Overview ... 234 Clinical Care Area (CCA) ... 235 Changing a CCA ...235 Programming a New Infusion with the Drug Library ... 239 Drug Name ...239 Drugs List ...239 Drug Profiles...240 Soft Limit ... 241 Update a New Drug Library Version ... 242 7

Sapphire Infusion Pump User Manual

10. ALARMS AND TROUBLESHOOTING ... 244 Alarms Overview... 244 Level 1 Alarms ... 245 Level 2 Alarms ... 246 Level 3 Alarms ... 247 Messages ... 249 Troubleshooting... 251

11. MAINTENANCE AND STORAGE ... 256 Cleaning and Disinfecting the Pump ... 256 Cleaning and Disinfection Procedure ... 258 Reprocessing the pump when used by a single patient multiple times ... 260 Preventive Maintenance ... 261 Routine Inspection and Maintenance Tasks ... 261 Alarm Testing ... 262 Certification... 263 Battery Care Information ... 264 Battery Classification ... 264 Battery Safety Information ... 265 Charging the Battery ... 267 Battery Maintenance ... 268 Transport and Storage ... 268

12. TECHNICAL SPECIFICATIONS ... 270 Pump Accuracy ... 270 Start-up and Trumpet Graphs... 272 Pump Specifications ... 276 Average Bolus Volume After Occlusion... 277 Environmental Specifications... 278 Operating Conditions ... 278 Environmental Conditions for Transport and Storage... 279 8

Electromagnetic Compatibility Statement ... 281 Electromagnetic Emission ...281 Electromagnetic Immunity ...282

13. LIMITED WARRANTY ...288

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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 ... 22

Product Overview and Indications The Q Core 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 in a clinical environment, and home users in an ambulatory environment and in pre-hospital medical air and ground transportation. The dedicated Q Core 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 r15. Verify that the software version that appears on the Sapphire turn-on screen is r15. The version number can be viewed from View system as well (for more information, refer to View Menu on page 211). This software version is intended for use only in the US.

Introduction

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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

• PCEA • Intermittent Epidural

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 75).

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

Treatment-Related Features

•

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

•

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

•

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

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Sapphire Infusion Pump User Manual

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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.

•

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

•

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

•

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

•

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.

•

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. • 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.

•

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.

•

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.

•

Range parameter safety check: Prevents entering infusion parameters that are outside of a precalculated safety range. The permitted ranges vary according to

Introduction

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the parameters already entered by the user, or by the limits defined in the Drug Library, if one is installed on the pump.

•

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

•

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

DFU

Directions for Use

EBP

External Battery Pack

ECG

Electrocardiogram

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

mUnits

Milliunits

M Units

Million Units

Introduction

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Term/Abbreviation

Meaning

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

Sec.

Secondary

TPN

Total Parenteral Nutrition

VI

Volume Infused

VTBI

Volume To Be Infused

Q Core

Q Core Medical Ltd.

Sapphire pump

Q Core Sapphire infusion pump family

SapphirePlus pump

Q Core SapphirePlus infusion pump

SapphireH100 pump

Q Core SapphireH100 infusion pump

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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 precautions and instructions 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:

• • • • •

Symbols and Labeling on page 17 Compliance and Classification on page 20 Biocompatibility on page 21 Sterilization on page 21 Degree of Protection Against Ingress of Water and Dust on page 21

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

Description

Location

Serial number.

Back of the pump casing and on the back of the mini cradle.

Catalog Number.

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

Batch code.

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

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.

Sapphire Infusion Pump User Manual

Symbol

Description

Location

Consult instructions for use.

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

Follow instructions for use.

Back of the pump casing, PCA Lockbox 250mL, and Mounting System.

The C and US indicators adjacent to the CSA mark signify that the product has been evaluated to the applicable CSA and UL standards, for use in Canada and the United States.

Back of the pump casing and Mounting System.

Date of manufacture (year).

Back of the pump casing.

Name of manufacturer.

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

Identify defibrillation proof and degree of protection against electric shock. Equipment Type BF Applied Part.

Back of the pump casing.

Input: 100-240 V; 50-60 Hz; Max. 120 VA Output: 10V DC; Max. 4.7 A.

Mounting System.

IP24

Dust and splash proof.

Back of the pump casing.

IPX1

Waterproof rating.

Mounting System.

Introduction

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Symbol IPX2 Rx Only

Description

Location

Waterproof rating.

EBP.

US federal law restricts this device to prescription only.

Back of the pump casing, on the back of the mini cradle, PCA Lockboxes 100, 250, and 500mL.

Waste Electrical and Electronic Equipment (WEEE) Disposal. This symbol indicates that used batteries and electronic equipment must not be disposed of as unsorted municipal waste, and must be collected separately. Contact an authorized representative for information concerning the decommissioning of your equipment.

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

ALARM

Alarm - LED, when lit, indicates an alarm situation in the operation of the pump. Refer to Hardware and Software Components on page 33.

Front casing of the pump, below the red LED.

CHARGE

Charge - LED, when lit, indicates that the battery is charging. Refer to Hardware and Software Components on page 33.

Front casing of the pump, below the yellow LED.

RUN

Run - LED, when lit, indicates that the pump is infusing. Refer to Hardware and Software Components on page 33.

Front casing of the pump, below the green LED.

STOP

Stop - Allows you to temporarily stop the infusion.

Front casing of the pump, below the touch screen.

On/Off

On/Off - Turns pump On and Off.

Front casing of the pump, below the touch screen.

Sapphire Infusion Pump User Manual

Compliance and Classification This manual has been written in conjunction with the requirements in the International Standard, IEC 60601-2-24 for Medical Electrical Equipment - Part 2-24: Particular Requirements for Safety of Infusion Pumps and Controllers. Data presented in the Technical Specification section reflect specific test conditions defined in this standard. Other external factors, such as varying back pressure, temperature, head height, set usage, fluid restrictions, solution viscosity, or combinations of these factors may result in deviations from the performance data presented.

•

IEC 60601-1, UL 60601-1 and CAN/CSA C22.2 601.1-M90 medical electrical equipment, which classifies the Sapphire pump as: • Class II • Type BF • Continuous operation • IP24 dust and splash proof • Not suitable for use in the presence of flammable anesthetic mixture with air or with oxygen or nitrous oxide

• •

IEC 60601-1-2: Electromagnetic compatibility.

•

IEC 60601-1-11: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.

•

IEC 60601-1-8: Requirements for alarm systems in medical electrical equipment and medical electrical systems.

•

IEC 60601-1-12 - Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment.

•

Defibrillator compliance statement: Equipment Type BF Applied Part.

IEC 60601-2-24: Infusion pumps and controllers, which classifies the Sapphire pump as a Type 4 pump (continuous infusion flow, combined with bolus delivery).

Introduction

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