Sapphire User Manual Rev 11 Ver 01

Copyright, Trademark and Patent Information © 2013, 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.

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.’s 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 17 for a complete list of warnings and cautions.

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Technical Assistance For technical questions, troubleshooting assistance and device problems, please contact your local agent/distributor. To locate authorized Hospira service centers near you, refer to Authorized Hospira service centers on page 212. You may also contact Q Core Medical Ltd. support via email to the following address: [email protected]

Meaning of the CE Mark Symbol The symbol represents adherence to Council Directive 93/42/EEC (14 June 1993) of the European Communities concerning medical devices. The electromagnetic compatibility (EMC) requirements are part of the essential requirements of the Medical Device Directive.

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Sapphire Infusion Pump User Manual

Contents 1. INTRODUCTION ...8 Product Overview and Indications ... 8 Dedicated Infusion Mode Configurations ...9 Features ...10 Terms and Abbreviations ... 11 Document Conventions ... 12 Safety and Compliance Information... 12 Symbols and Labeling ...13 Compliance and Classification ...16 Biocompatibility ...17 Sterilization ...17 Degree of Protection Against Ingress of Water and Dust ...17 Warnings and Safety Precautions... 17 General Warnings and Precautions ...18 Proper Use of the Pump ...20

2. COMPONENTS, ACCESSORIES, AND ADMINISTRATION SETS...26 Unpacking the Pump... 26 Hardware and Software Components ... 27 Touch Screen ...28 Using Pump Accessories ... 29 Mini-Cradle...29 PCA Lock Boxes ...31 PCA/PCEA Bolus Handle ...34 Charger ...35 Administration Sets...36

3. FUNDAMENTAL CONCEPTS AND OPERATIONS ...40 Working with the Main Display ... 40 Using the Keypad...40 Overview of Toolbar Function Keys...42 Overview of Icons...43 Selecting Infusion Mode ... 44 Enabling Special Features ... 46 4

Setting KVO rate ...48

4. GETTING STARTED...50 Typical Workflow ... 50 Turning the Pump On... 52 Turning the Pump Off ...52 Connecting the Reservoir Container... 53 Opening the Safety Door... 54 Inserting the Administration Cassette... 55 Removing the Administration Cassette ...57 Automatic Priming Using the Pump ... 58 Priming Manually ...60

5. USING THE INFUSION MODES ...62 Continuous Mode ... 62 Infusion Parameters: Continuous Mode ...65 Starting a Continuous Infusion ...65 Continuous Mode: Mid-infusion Actions ...75 Multi-step Mode ... 84 Infusion Parameters: Multi-step Mode...85 Starting a Multi-step Infusion...85 Multi-step Mode: Mid-infusion Actions ...91 Total Parenteral Nutrition (TPN) Mode... 93 Infusion Parameters: TPN Mode...94 Starting a TPN Infusion...95 TPN Mode: Mid-infusion Actions ...96 Intermittent Mode... 97 Infusion Parameters: Intermittent Mode ...98 Starting an Intermittent Infusion...98 Intermittent Mode: Mid-infusion Actions ...103 Patient Controlled Analgesia (PCA) Mode ... 105 Infusion Parameters: PCA Mode ...106 Starting a PCA Infusion...106 PCA Mode: Mid-infusion Actions ...111 Epidural Mode ... 113 Patient Controlled Epidural Analgesia (PCEA) Mode...114 Epidural Intermittent Mode ...122

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Sapphire Infusion Pump User Manual

6. BASIC INFUSION OPERATIONS ...130 Starting New Infusions: Shortcuts ... 130 Repeating Last Infusion ...130 Using a Preset Program ...132 Resuming Infusions After Pump Shutdown ... 133 Mid-infusion Actions ... 133 Pausing Infusions ...133 Aborting Infusions...135 Locking the Screen ...136 Activating Patient Lockout ...136 Ending Infusion ... 137

7. OPTIONS MENU: CONFIGURING, VIEWING AND TESTING ...138 Main Options: Overview ... 138 Setting Infusion Mode... 139 Managing Configuration Settings ... 139 Managing Alarm Settings...140 Configuring General Settings ...142 Defining Regional Parameters ...145 Testing System Function ...146 View Menu ...147 Using Special Mode Options ... 152 PCA Options Menu...152 Epidural Mode Options Menus ...153

8. USING ADVANCED FEATURES ...154 Managing Authorization Levels... 154 Setting Authorization Lock Levels ...156 Password Re-entry... 157 Creating and Editing Preset Programs... 158 Programming Delayed Start Infusions... 161 Using the New Patient Feature ... 162

9. DRUG LIBRARY...166 Overview ... 166 Clinical Care Area (CCA) ... 167 Programming a New Infusion with the Drug Library ... 168 Drug Name...168 6

Drug List ...169 Drug Profiles...169 Soft Limit ... 170 Update New Drug Library Version ... 171

10. ALARMS AND TROUBLESHOOTING ...172 Alarms Overview ... 172 Level 1 Alarms... 173 Level 2 Alarms... 174 Level 3 Alarms... 175 Messages ... 177 Troubleshooting ... 179

11. MAINTENANCE AND STORAGE ...182 Cleaning and Disinfecting the Pump ... 182 Preventive Maintenance... 183 Routine Inspection and Maintenance Tasks ...184 Alarm Testing...185 Certification ...185 Battery Care Information... 186 Battery Classification ...187 Battery Safety Information ...187 Charging the Battery ...188 Battery Maintenance...189 Transport and Storage... 189

12. TECHNICAL SPECIFICATIONS ...190 Pump Accuracy ... 190 Start-up and Trumpet Graphs ...191 Pump Specifications ... 196 Average Bolus Volume After Occlusion ... 197 Environmental Specifications ... 199 Operating Conditions...199 Environmental Conditions for Transport and Storage ...199 Electromagnetic Compatibility Statement ... 201 Electromagnetic Emission...201 Electromagnetic Immunity ...202

13. LIMITED WARRANTY ...208 7

Sapphire Infusion Pump User Manual

Chapter 1: Introduction The following sections describe the functions and features of the Sapphire pump, and provide a summary of safety and regulatory information: Product Overview and Indications ... 8 Terms and Abbreviations ... 11 Document Conventions ... 12 Safety and Compliance Information ... 12 Warnings and Safety Precautions ... 17

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 pump includes the following infusion modes for all intended uses: Continuous, Intermittent, TPN, PCA, Multi-step, and Epidural (specific delivery modes may be turned off by the facility's technical staff). 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 ground transportation. The dedicated Q Core administration sets for the Sapphire pump are intended for single-patient use and single-use only. This user manual supports the use of Sapphire software version r11. Verify that the software version that appears on the Sapphire turn on screen is r11. The version number can be viewed from View system as well (for details, refer to View Menu on page 147). This software version is intended to be used only outside of the US.

Introduction

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

Infusion Modes Supported

PCA

• PCA • Continuous

Epidural

• PCEA • Intermittent Epidural

TPN

• TPN • Continuous

Multi-therapy

2 or more of the following:

• Continuous • Intermittent • TPN • PCA • Multi-step • Epidural Each infusion mode is assigned a unique color that appears on the Indicators Bar, helping users to easily differentiate between the different modes (Figure 3.1, “Indicators Bar: Infusion Mode,” on page 45).

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Sapphire Infusion Pump User Manual

Features The features of the Sapphire pump are designed to simplify treatment and ensure patient safety. Treatment-Related Features

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Single platform device: The infusion 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 enable you to update infusion parameters without stopping the infusion. 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: Enables saving the infusion parameters of commonly used protocols, and allows a quick-start infusion using these parameters. Piggyback (Continuous 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 mass units; mg, mcg or Units. • Patient weight can be incorporated into the infusion program.

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. 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.

Introduction

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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. 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 limits.

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

Meaning

AFFV

Anti-Free-Flow-Valve

CCA

Clinical Care Area

ECG

Electrocardiogram

EMC

Electromagnetic compatibility

EMI

Electromagnetic interference

Epi. Int

Epidural Intermittent

H

Hour

Kg

Kilograms

KVO

Keep Vein Open

mcg

Micrograms

min

Minutes

mg

Milligrams

mL

Milliliters

Occ.

Occlusion

PCA

Patient Controlled Analgesia

PCEA

Patient Controlled Epidural Analgesia

TPN

Total Parenteral Nutrition

VI

Volume Infused

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Sapphire Infusion Pump User Manual

Term/Abbreviation

Meaning

VTBI

Volume To Be Infused

Q Core

Q Core Medical Ltd.

Sapphire pump

Q Core Sapphire infusion pump

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 13

• • • •

Compliance and Classification on page 16 Biocompatibility on page 17 Sterilization on page 17 Degree of Protection Against Ingress of Water and Dust on page 17

Introduction

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

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Description

Location

Serial number

Back of the pump casing and cradles

CE certification mark

Back of the pump casing, cradles, PCA Lock Box 100 and PCA Lock Box 500

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 and on the inside casing of the mini-cradle

Caution: Electrical Shock Hazard. Do not remove cover. Service to be performed by qualified personnel only.

Inside casing of the cradle

Danger: Possible explosion hazard if used with flammable anesthetic.

Inside casing of the cradle

Storage temperature range.

Shipping package

Sapphire Infusion Pump User Manual

Symbol

Introduction

Description

Location

Storage humidity range.

Shipping package

Storage atmospheric pressure range.

Shipping package

Consult instructions for use.

Back of the pump casing, cradles and PCA Lock Box 500

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 on the front of the cradle

Date of manufacture (year).

Back of the pump casing cover, and on the back of the cradle

Name of manufacturer.

Back of the pump casing cover, on the back of the cradles, PCA Lock Box 100 and PCA Lock Box 500

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Symbol

Description

Location

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

Back of the pump casing cover

Input: 100-240 V; 50-60 Hz; Max. 0.5A Output: 10V DC; Max. 1.25A

Bottom of the cradle (which houses the AC/ DC adaptor)

IP24

Dust and splash proof.

Back of the pump casing cover

IPX1

Waterproof rating

Cradle casing

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.

Back of the pump casing cover, and on the cradle

ALARM

Alarm - LED, when lit, indicates an alarm situation in the operation of the pump. See Hardware and Software Components on page 27

Front casing of the pump, below the red LED

CHARGE

Charge - LED, when lit, indicates that the battery is charging. See Hardware and Software Components on page 27

Front casing of the pump, below the orange LED

RUN

Run - LED, when lit, indicates that the pump is infusing. See Hardware and Software Components on page 27

Front casing of the pump, below the green LED

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Sapphire Infusion Pump User Manual

Symbol

Description

Location

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

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.

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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). 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. Defibrillator compliance statement: Equipment Type BF Applied Part.

Introduction

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Biocompatibility All materials in components of the administration sets that are in the fluid pathway have been tested for biocompatibility, and are in compliance with applicable international standards ISO 10993-1 for biocompatibility.

Sterilization Administration sets for the Sapphire pump are sterilized with ethylene oxide (EO), according to the sterilization requirements of ISO 11135-1.

Degree of Protection Against Ingress of Water and Dust The Sapphire pump meets the IP24 splash/dust standard according to IEC 60601-1-11. Protects from water which is sprayed at 10L/min at a pressure of 80-100kN/m2 for 5 minutes at all angles, and protects from touch by objects greater than 12 millimeters such as fingers.

Warnings and Safety Precautions The following sections contain important safety information. All warnings and safety precautions should be read carefully before operating the Sapphire pump: • General Warnings and Precautions on page 18 • Proper Use of the Pump on page 20 Safety information specific to particular pump functions appears in the relevant sections of this manual.

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Sapphire Infusion Pump User Manual

General Warnings and Precautions To ensure safety and proper operation, read the User Manual and any instructions accompanying disposables or accessories before operating this device. In addition, adhere to the following safety guidelines: Avoid placing the administration set or power cord on the floor, or any other location where it can accidentally be damaged or provide a risk of strangulation, particularly due to excessive length.

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To avoid damage to the pump and its accessories, keep the equipment away from unattended children and pets. Do not clean, disinfect or sterilize any part of the pump by autoclaving, or with ethylene oxide gas. Doing so may damage the pump and void the warranty. Only external parts of the pump should be disinfected. If the pump is dropped or appears to be damaged, it should be taken out of service and inspected by Q Core Medical Ltd. trained, qualified personnel only.

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Do not operate the pump with the safety door open.

Waste Disposal Take care to dispose of the packaging, the administration sets, the battery, and any other electronic components in accordance with applicable environmental laws (such as the WEEE Directive for Waste Electrical and Electronic Equipment). Contact your local authority to determine the proper method of disposal. Waste Disposal Safety Precautions

• •

Keep used plastic reservoir containers, packaging and tubing out of the reach of children. Administration sets should be disposed of in a proper manner, considering the nature of residual fluid that may be contained within, in accordance with hospital disposal practices.

Introduction

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•

Do not dispose of the battery in or near fire.

Explosion Hazard The equipment is not suitable for use in the presence of flammable anesthetic mixture with air or with oxygen or nitrous oxide. Electric Shock Hazards To promote safety, always adhere to the warnings listed below. Electrical Safety Precautions

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• •

• •

Access to any internal part of the Sapphire pump and the performance of any service procedures should be carried out only by a qualified service technician, fully trained in the operation of the infusion pump. Disconnect the power supply before servicing. Disconnect the battery prior to opening the pump casing. Voltage present on internal components may cause severe shock or death on contact. Connect AC power to the pump only via a Q Core supplied power adapter. Do not touch the pump to cradle (P2C) connection in the back on the pump.

Electromagnetic Compatibility The Sapphire pump is designed to conform to electromagnetic compatibility (EMC) standard IEC 60601-1-2 and to operate accurately in conjunction with other medical equipment which also meets the requirements of this standard. To avoid electromagnetic interference that may affect the operation of the pump, do not use the pump near sources of strong electric and magnetic interference (EMI), such as large electric motors.

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Sapphire Infusion Pump User Manual

Electromagnetic Safety Precautions

•

•

Do not expose the pump to therapeutic levels of ionizing radiation, as permanent damage to the pump’s electronic circuitry may occur. It is preferable to remove the pump from the patient during therapeutic radiation sessions. Do not use the pump in the vicinity of magnetic resonance imaging (MRI) equipment, as magnetic fields may adversely affect the operation of the pump. Remove the pump from the patient during MRI procedures, and keep it at a safe distance from magnetic energy.

Proper Use of the Pump Although the Sapphire pump has been designed and manufactured to exacting specifications, it is not intended to replace trained personnel in the monitoring of infusions. Home users must be trained by their medical provider before using the Sapphire pump. Clinicians are advised to verify the proper route of delivery, and the patency of the infusion site.

When using the pump, periodic patient monitoring must be performed to ensure that the infusion is proceeding as expected. The pump is capable of developing positive fluid pressures to overcome widely varying resistances to flow, such as resistance imposed by small-gauge catheters, filters, or intra-arterial infusions. Although the pump is designed to stop fluid flow when an alarm occurs, it is neither designed nor intended to detect infiltrations, and will not alarm under infiltration conditions. When using the pump, use only Q Core's approved accessory equipment.

Introduction

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