Eitan Sapphire Multi-Therapy Manuale utente

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.

Information

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.

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

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

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

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

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