eitan medical Sapphire User manual

15025-048-1078 | Rev16.10 Ver01 / 04.2023

Sapphire Infusion Pump User Manual1
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
© 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.

2
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.

Sapphire Infusion Pump User Manual3
Technical Assistance
For technical questions, troubleshooting assistance and reporting of unexpected
events, please contact your local agent/distributor, and refer to Technical Support
Contacts on page 330. You may also contact Eitan Medical Ltd. support via email to the
following address: [e-mail]
Serious Incident Reporting
Any serious incident that has occurred in relation to the device should be reported to
[e-mail] and the local competent authority.

4
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 .....................................................................30
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

Sapphire Infusion Pump User Manual5
Sapphire Connect (Version 1.0)..........................................................56
Power Supply.......................................................................................79
Integrated Power Supply....................................................................79
USB-C Power Supply (Sapphire Connect power supply).................81
External Battery Pack..........................................................................83
Multi-Pump Mounting System ...........................................................90
Administration Sets.............................................................................95
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

6
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

Sapphire Infusion Pump User Manual7
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 ...........................................................250
PCA Options Menu...........................................................................250
Epidural Mode Options Menu.........................................................251
8. USING ADVANCED FEATURES ...................................252
Managing Authorization Levels........................................................252
Setting Authorization Lock Levels ...................................................254
Password Re-entry............................................................................255
Creating and Editing PreSet Programs ............................................256
Using the Set Delay Feature.............................................................259
Using the New Patient Feature ........................................................263
Monitoring the Accumulated Volume Infused (Shift's Total) ............264
Viewing Accumulated VI...................................................................264
Clearing Accumulated VI..................................................................265
9. DRUG LIBRARY........................................................266
Overview ..........................................................................................266
Clinical Care Area (CCA) ..................................................................267
Changing a CCA ...............................................................................267
Programming a New Infusion with the Drug Library........................271
Drug Name........................................................................................271

8
Drugs List .......................................................................................... 271
Drug Profiles ..................................................................................... 272
Soft Limit.......................................................................................... 273
Update a New Drug Library Version ................................................ 274
10. ALARMS AND TROUBLESHOOTING .......................... 276
Alarms Overview.............................................................................. 276
Error – Level 1, High Priority Alarms................................................ 277
Alarm – Level 2, High Priority Alarms .............................................. 278
Messages – Level 3, Low Priority Alarms ......................................... 281
Troubleshooting............................................................................... 283
11. MAINTENANCE AND STORAGE............................... 290
Cleaning and Disinfecting the Pump............................................... 290
Cleaning and Disinfection Procedure............................................. 292
Reprocessing the pump when used by a
single patient multiple times ........................................................... 294
Cleaning Sapphire Connect and Electric
Connectors of Sapphire Accessories ............................................... 295
Preventive Maintenance .................................................................. 298
Routine Inspection and Maintenance Tasks ................................... 298
Alarm Testing .................................................................................... 299
Certification....................................................................................... 300
Battery Care Information ................................................................. 301
Battery Classification........................................................................ 302
Battery Safety Information ............................................................... 302
Charging the Battery........................................................................304
Battery Maintenance ........................................................................ 305
Transport and Storage ..................................................................... 305

Sapphire Infusion Pump User Manual9
12. TECHNICAL SPECIFICATIONS ...................................306
Pump Accuracy ................................................................................306
Tiered Flow Rate Accuracy Specifications ......................................307
Start-up and Trumpet Graphs ..........................................................309
Pump Specifications.........................................................................314
Average Bolus Volume After Occlusion ...........................................316
Environmental Specifications ...........................................................317
Operating Conditions.......................................................................317
Environmental Conditions for Transport and Storage ...................317
Electromagnetic Compatibility Statement .......................................319
Electromagnetic Emission................................................................319
Electromagnetic Immunity ...............................................................320
13. LIMITED WARRANTY ..............................................328

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 ............................................................................ 25
Product Overview and Indications
The Sapphire Infusion Pump is intended for controlled delivery through intravascular,
subcutaneous, intra-arterial,Perineural and epidural routes. The pump is designed to
deliver saline, Total Parenteral Nutrition (TPN), lipids, IV medication,Perineural
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, air and 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 r16.10. Verify that the
software version that appears on the Sapphire turn-on screen is r16.10. The version
number can be viewed from View system as well (for more information, refer to View
Menu on page 243).
Chapter 1: Introduction
This software version is intended for use only in the US.

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

Introduction 12
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 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.
•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.

Sapphire Infusion Pump User Manual13
•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
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
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

Sapphire Infusion Pump User Manual15
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 Sapphire infusion pump family
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 23
•Biocompatibility on page 24
•Sterilization on page 24
•Degree of Protection Against Ingress of Water and Dust on page 24
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.

Sapphire Infusion Pump User Manual17
Symbols and Labeling
The following table describes the labels and symbols that may appear on the Sapphire
pumps or pump accessories and their components, and identifies their locations on the
equipment.
Symbol 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,
back of the Sapphire
Connect, back of the mini
cradle, EBP, PCA
Lockboxes 100, 250 and
500mL, and Mounting
System.
Medical Device. Back of the 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.

Introduction 18
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.
Follow instructions for use. Back of the pump casing,
on the back of Sapphire
Connect, PCA Lockbox
250mL, and Mounting
System.
Symbol Description Location

Sapphire Infusion Pump User Manual19
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 and address of the
manufacturer.
Back of the pump casing,
on the back of Sapphire
Connect, 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,
and front of the Sapphire
Connect.
IPX1 Waterproof rating. Mounting System.
IPX2 Waterproof rating. EBP.
Symbol Description Location