Eitan Sapphire Multi-Therapy User manual

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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
© 2016, 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.

Sapphire Infusion Pump User Manual2
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.
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.
The use of Administration sets manufactured by ICU Medical
is approved for sale through March, 2023.

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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]om

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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

Sapphire Infusion Pump User Manual5
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

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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

Sapphire Infusion Pump User Manual7
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

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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

Sapphire Infusion Pump User Manual9
Electromagnetic Compatibility Statement .......................................281
Electromagnetic Emission................................................................281
Electromagnetic Immunity ...............................................................282
13. LIMITED WARRANTY ..............................................288

Introduction 10
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).
Chapter 1: Introduction
This software version is intended for use only in the US.

Sapphire Infusion Pump User Manual11
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.
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.
Pump Type Delivery Modes Supported
Multi-therapy 1 or more of the following:
•Continuous
•Intermittent
•TPN
•PCA
•Multi-step
•Epidural
Epidural •PCEA
•Intermittent Epidural

Introduction 12
•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
•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

Sapphire Infusion Pump User Manual13
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.

Introduction 14
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

Sapphire Infusion Pump User Manual15
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
Term/Abbreviation Meaning

Introduction 16
Document Conventions
The following messages in this manual prompt readers to pay special attention to
specific points:
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
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.

Sapphire Infusion Pump User Manual17
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. 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.

Introduction 18
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.
Symbol Description Location

Sapphire Infusion Pump User Manual19
IPX2 Waterproof rating. EBP.
Rx Only 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.
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.
Symbol Description Location