Hospira Symbiq 16026 User manual [gb]

Download

Page 1

System

Operating

Manual

For use with the SYMBIQ One-Channel Infuser

List Number 16026-04-79 and above

and SYMBIQ

List Number 16027-04-79 and above

™

Two-Channel Infuser

Hospira, Inc., Lake Forest, IL 60045 430-11348-005 (A, 03/08)

Page 2

System Operating Manual

For List Number 16026-04 (One-Channel Infuser),

16027-04 (Two-Channel Infuser).

STOP

/ EJECT

LOAD

DOPamine

0mL/hr

13.1 mL / hr

13.1 mL/ hr

0mL

103 mL

96.1 mL

DOPamine

[400 mg / 250 mL]

[400mg/250mL

Dose

Rate

VTBI

Press Dose, Rate, or VTBI button (When available) to edit.

Press TabA to display Near Viewing Delivery screen.

Press Tab A or Tab B to display Near Viewing Delivery screen.

Mode

08:45 AM

08:47 AM

mcg / kg / min

mcg/kg/min

13.

mL / hr

96.

Mode

Settings

Settings Logs LockStandby

ICU

]

Logs

Lock

/EJECT

LOAD

DOPamine

DOPamine IV Fluid

[400 mg / 250 mL]

[ 400 mg /

Dose

Rate

VTBI

Press Dose, Rate, or VTBI button (When available) to edit.

Press TabA to display Near Viewing Delivery screen.

Press Tab A or Tab B to display Near Viewing Delivery

Alarm

screen.

Mode

08:45 AM

08:47 AM

0mL/hr

13.1 mL / hr

13.1 mL/ hr

0mL

103 mL

96.1 mL

250

mcg / kg / min

mcg/kg/min

13.

mL / hr

96.

Mode

Settings

Settings Logs LockStandby

STOP

ICU

IV Fluid

]

Rate

VTBI

Logs

75 mL / hr

1000 mL

1000

Lock

mL / h

/EJECT

LOAD

IV Fluid

Alarm

DC_TitlePageInfuser_Single.eps

DC_TitlePageInfuser_Dual.eps

The SYMBIQ™ Infusion System is designed for use by health care professionals. The Hospira

Customer Support hotline is available 24 hours a day (in the USA) to provide consultation and

technical assistance regarding the SYMBIQ™ Infusion System.

Hospira Technical Support Operations

1-800-241-4002

To order additional copies of this manual

call 1-877-946-7747

SYMBIQ™ Infusion System Operating Manual

Page 3

Change History

Part Number Description of Change Pages Changed Revision Date

430-11348-001 Initial Release 11/22/06

430-11348-002 Second Release All 12/06

430-11348-003 Third Release All 07/07

430-11348-004 Fourth Release All 08/07

430-11348-005 Fifth Release All 03/08

SYMBIQ™ Infusion System Operating Manual

Page 4

NOTES:

SYMBIQ™ Infusion System Operating Manual

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Contents

CHAPTER 1: INTRODUCTION 5

Intended Audience . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Document Conventions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Type Conventions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

Warnings and Cautions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

Warnings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

General Cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

Epidural Administration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

Administration Sets and Delivery Cautions. . . . . . . . . . . . . . . . . . . . . . . . . 8

Battery Operation Cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

Unintended Bolus Delivery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

Cleaning Cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

US FCC (Federal Communications Commission) Statement . . . . . . . . . . . . . .11

FCC Interference Statement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11

Wireless Device Caution. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11

Radio Frequency Exposure Statement . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

Electrical Artifacts in Clinical Settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

CHAPTER 2: INFUSER OVERVIEW 15

Infuser Layout—Front . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

Infuser Buttons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

Touchscreen Buttons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

Touchscreen Button Appearance. . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

Touchscreen Icons and Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

Infuser Layout—Rear . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

Rear Infuser AC Power Outlet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

Wireless Communication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

Infuser Layout—Underside . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

Infuser Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

Channel Level Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

Channel Feature Availability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

Program Level Features Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26

Device Level Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

Settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28

Logs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

Standby: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

Program Lock . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

CHAPTER 3: INFUSER OPERATIONS 37

Infuser Operations Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

Power Modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

AC Power . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

Channel LEDs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39

Battery Power . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41

A/C Power LED . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43

Touchscreen Visibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44

Power Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44

Programming Mode. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44

SYMBIQ™ Infusion System Operating Manual 1

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Contents

Basic Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45

Delivery Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45

Stop Mode. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47

General Programming Guidelines. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50

Calculated Values . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50

Invalid Value Handling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51

Value Rounding . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51

Biomed Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52

CHAPTER 4: INFUSER PREPARATION 53

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53

Attaching and Removing an Infuser from an I.V. Pole. . . . . . . . . . . . . . . . . . . 53

Infuser Configurations on an I.V. Pole . . . . . . . . . . . . . . . . . . . . . . . . . . . 54

Attaching Two Infusers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57

Detaching Connected Infusers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60

Administration Sets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62

Preparing Administration Sets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64

Fluid Container Compatibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64

To Check LED and Speaker Function. . . . . . . . . . . . . . . . . . . . . . . . . . . . 69

Loading an Administration Set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69

Removing a Cassette . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73

Ejecting a Cassette in an Emergency. . . . . . . . . . . . . . . . . . . . . . . . . . . . 74

CHAPTER 5: PROGRAM (BASIC) THERAPY 77

Programming a Basic Therapy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77

Specifying Medication Concentration . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82

End of Infusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88

Titrating an Infusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89

CHAPTER 6: PIGGYBACK 93

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93

CHAPTER 7: BOLUS 99

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99

Bolus. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99

CHAPTER 8: ADVANCED THERAPIES 105

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105

Multistep Therapy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105

Intermittent Therapy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .112

Interchannel Sequencing Therapy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 120

2 SYMBIQ™ Infusion System Operating Manual

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Contents

CHAPTER 9: PROGRAM OPTIONS 127

Power Priming . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 127

Deliver at End of Infusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 131

KVO Rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 132

Delayed Start . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 132

Alarm Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 134

Distal Occlusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 134

Proximal Occlusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 137

Infusion Complete Callback . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 139

Air-In-Line. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 141

Nearing End Of Infusion. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 142

CHAPTER 10: ALARM AND SYSTEM MESSAGES 145

Alarm. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 145

Alarm Appearance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 146

Minimized Alarm Tabs. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 147

Alarm Urgency . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 148

Alarm Silencing. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 148

Multiple Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 149

System Messages. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 150

Program Resulting in an Outside Soft Limits Message. . . . . . . . . . . . . . 150

Exceeded Soft Limits Message . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 151

Program Resulting in an Outside Hard Limit Message. . . . . . . . . . . . . . 152

Exceeded Hard Limits Message . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 154

Invalid Entry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 155

CHAPTER 11: STORED DATA 157

Patient Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 157

Clinical Care Areas . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 158

Changing CCAs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 160

Shift Totals Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 162

Clearing Shift Totals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 162

Event Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 163

Alarm Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 164

Rule Set Alert Override Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 165

Default Drug Library . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 166

High-Risk Medications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 167

Updating Drug Library . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 169

CHAPTER 12: CLEANING, MAINTENANCE, AND STORAGE 171

Cleaning the Infuser . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 171

Cleaning Cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 172

Cleaning Lock . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 172

Battery Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 173

Battery Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 174

Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 174

Infuser Maintenance and Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 174

Product Handling and Disposal. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 174

SYMBIQ™ Infusion System Operating Manual 3

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Contents

CHAPTER 13: PRODUCT SPECIFICATIONS 175

Flow Rate Accuracy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 179

Flow Continuity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 179

Trumpet Curves. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 179

Sample Trumpet Curve. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 180

Flow Effects For Varying Delivery Conditions . . . . . . . . . . . . . . . . . . . . . . . . 181

Backpressure Variation Effects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 181

Negative Container Height Effects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 181

Wireless LAN Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 188

APPENDIX A: SYSTEM MESSAGES AND TROUBLESHOOTING 189

APPENDIX B: ALARM MESSAGES AND TROUBLESHOOTING 199

APPENDIX C: ACCESSORIES, ADMINISTRATION SETS, AND COMPONENTS 211

APPENDIX D: GLOSSARY 213

APPENDIX E: DEFAULT DRUG LIBRARY (DDL) 221

APPENDIX F: UNITS OF MEASURE 223

INDEX 225

SYMBIQ™ INFUSION SYSTEM WARRANTY 231

4 SYMBIQ™ Infusion System Operating Manual

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Chapter 1: Introduction

The SYMBIQ™ Infusion System is a general purpose infuser designed to deliver fluids, solutions, medications, agents, nutritionals, electrolytes, blood and blood products for parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural, or irrigation routes of administration.

The SYMBIQ™ Infusion System is available as a one-channel or a two-channel infuser. These infusers may be connected to configure a three or four channel pump. The connecting mechanism is designed to allow a maximum of 1 additional pump to be connected. The Symbiq Infusion System can be configured as a one-, two-, three-, or four-channel pump.

A cassette-based, multi-function device, the SYMBIQ™ Infusion System is powered by either AC power or can be powered by the enclosed rechargeable battery. The SYMBIQ™ Infusion System delivers Basic therapy or Advanced therapies such as Multistep, Intermittent, and Interchannel Sequencing.

The SYMBIQ™ Infusion System is intended for use primarily in a hospital setting. Other care areas where the infuser can be used include: home care, nursing homes, mobile intensive care, ambulatory infusion centers, hospice, subacute facilities, outpatient/surgical centers, long term care, urgent care, transport, and physician offices.

Intended Audience

The SYMBIQ™ Infusion System is intended for use at the direction of or under the supervision of licensed physicians or certified healthcare professionals who are trained in the use of infusers and the administration of parenteral, enteral, and epidural fluids and medications. Training should emphasize preventing I.V. related complications including appropriate precautions to prevent accidental infusion of air. Use the SYMBIQ™ Infusion System according to established hospital or institution guidelines, policies, and procedures.

CAUTION: Federal (USA) law restricts this device to sale by or on the order of

physicians or other licensed health practitioners.

Document Conventions

Throughout this manual, the following conventions are used to call attention to warnings, cautions, notes, and tips:

WARNING: A warning message contains special safety emphasis and must

be observed at all times. Failure to observe a warning message is potentially life threatening.

CAUTION: A caution appears in front of a procedure or statement. It contains

information that could prevent product damage or hardware failure. Failure to observe a caution could result in patient or user injury.

SYMBIQ™ Infusion System Operating Manual 5

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Chapter 1: Introduction Warnings and Cautions

Note: A Note highlights information that helps explain a concept or procedure.

Tip: A Tip contains useful information, hints, and shortcuts that make the product easier to use.

Figures and graphics are rendered as representations to approximate the actual product, and may not exactly reflect the product.

Type Conventions

This manual uses the following style conventions to identify recurring objects.

Table 1.1 Type Conventions

Convention Description Example

Blue text This indicates that it is a hypertext link. See Table 1-1.1, “Type Conventions,”

on page 6.

Bold Introduces important terms

Arial narrow Names a button

Small Capitals Names of screens

The secondary container must be higher than the primary container.

Press Enter button

The STARTUP SCREEN displays

Warnings and Cautions

The SYMBIQ™ Infusion System is designed and manufactured to be safe, reliable, and easy to use. This section describes possible hazards and explains how to prevent these hazards.

Warnings

• When infusing at low delivery rates (5.0 mL/hr or less), use thick-walled microbore sets to reduce the fluid bolus amount that may be delivered when a distal line occlusion is released.

• To obtain optimal low flow continuity at rates (between 0.1 and 1.0 mL/hr) manually prime the set.

• DO NOT use medications incompatible with silicone rubber or PVC plastic or medications not stable under infusion conditions.

• ALWAYS prime the administration set to remove air from the cassette, tubing, and injection sites prior to connecting to the patient. ALWAYS disconnect the administration set from the patient prior to priming or purging.

• Arrange tubing, cords, and cables to minimize the risk of patient strangulation or entanglement.

• Consult medication labeling to confirm medication compatibility, concentration, delivery rates, and volumes are all suitable for desired delivery mode.

• When using the infuser for secondary deliveries (piggybacking), ensure the fluids being infused are both chemically and physically compatible.

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Warnings and Cautions Chapter 1: Introduction

• When an administration set is loaded in the infuser, a small amount of fluid is expelled each time the cassette carriage is opened or closed. If potent medications are being used, disconnect the administration set from the patient to prevent over medicating the patient.

• Delayed respiratory depression following continuous epidural administration of preservative-free morphine sulfate has been reported.

• Administer only anesthetics and analgesics approved for epidural administration (as indicated by the medication’s FDA approved labeling). Epidural administration of medications other than those indicated for epidural use could result in serious patient injury.

• Rate accuracy can be affected by variations of fluid viscosity, fluid temperature, head height, back pressure or any combination of these. Additional factors that may influence rate accuracy are administration set configuration and the duration of time the administration set is utilized.

• When delivering a secondary infusion, use a SYMBIQ™ primary administration set with a backcheck valve.

• For piggyback deliveries from a secondary container, ensure the secondary container is hung higher than the primary container.

• Use of additional non-SYMBIQ™ equipment or accessories on the same I.V. line to the patient may cause potential safety hazards.

• After pressing

Emergency Stop, verify that the Emergency Stop Banner is displayed and delivery

has stopped.

General Cautions

• Federal (USA) law restricts the sale of this device. It is sold by order of a physician or other licensed health practitioner.

• DO NOT place the SYMBIQ™ Infusion System in service if it fails any of the diagnostic self-tests.

• Before use, inspect the AC cord for defects.

• Before use, ensure the infuser has a functional battery installed. Use of a properly installed and functional battery ensures that the infuser operates properly.

• Only qualified biomedical technicians should access the infuser’s Biomed mode.

• To prevent product damage, use proper care during unpacking and installation. DO NOT use a SYMBIQ™ Infusion System if it appears damaged in any way.

• DO NOT attach more than two connected infusers to an I.V. pole (see “Attaching and

Removing an Infuser from an I.V. Pole” on page 53).

• When a primary infuser is connected to an AC power main, never connect more than one additional infuser in series to the rear infuser AC power outlet. Connecting more than one additional infuser in series may cause an electrical safety hazard (see “Rear Infuser AC

Power Outlet” on page 22 for more information).

• Use ONLY Hospira MedNet

Server Suite with the SYMBIQ™ Infusion System.

• To prevent personal injury or product damage, make sure the pole clamp is tightened properly and the infuser is securely attached.

SYMBIQ™ Infusion System Operating Manual 7

Page 12

Chapter 1: Introduction Warnings and Cautions

• Disconnect AC power line prior to opening unit or changing battery.

• Manually ejecting a cassette renders that channel incapable of infusing until it is reset by Biomed.

• NEVER use sharp objects such as fingernails, pens, pencils, paper clips, or needles as means to program the infuser. The

LCD screen may scratch.

Epidural Administration

Recommended use of the epidural route is to provide anesthesia or analgesia for periods up to 96 hrs.

• This device can be used to administer only those anesthetics/analgesics approved for epidural administration (as indicated or allowed by the medications’ FDA approved labeling). Epidural administration of medications other than those indicated for epidural use could result in serious injury to the patient.

• For epidural administration, the use of Hospira catheters, SYMBIQ™ sets without Y-sites, and “epidural” stickers indicating ongoing epidural administration are recommended.

Administration of medications via the epidural route should be limited to personnel familiar with associated techniques and patient management problems. Proper epidural placement of the catheter is essential since catheter migration could result in intravascular or intrathecal administration. Facilities practicing epidural administration must be equipped with resuscitative equipment, oxygen, naloxone, and other resuscitative medications. Adequate monitoring equipment (e.g., Oximetry and/or Capnography) is recommended for continuous monitoring of the patient during epidural administration. Patients must be observed frequently for side effects in a fully-equipped and staffed environment for at least 24 hours following completion of medication administration by the epidural route. DELAYED RESPIRATORY DEPRESSION FOLLOWING CONTINUOUS EPIDURAL ADMINISTRATION OF PRESERVATIVE-FREE MORPHINE SULFATE HAS BEEN REPORTED. If over-delivery occurs during administration, observe the patient closely for signs of spinal cord compression (disorientation, headache, transient neuralgias) and medication overdose.

Administration Sets and Delivery Cautions

• USE ONLY Hospira SYMBIQ™ administration sets with the SYMBIQ™ Infusion System. Use of unauthorized sets may result in injury to the patient or damage to the infuser.

GemStar

• To prevent contamination, use aseptic techniques with all fluid-path connections. Remove protective coverings as administration set assembly progresses.

• When priming is complete and the cassette flow stop is closed, ensure no fluid flows at the distal end of the administration set. If fluid flow is observed, DO NOT use the administration set.

• Before using a CLAVE DO NOT use needles to access the CLAVE

• Before removing the cassette from the infuser, close ALL slide clamps for added free flow protection.

8 SYMBIQ™ Infusion System Operating Manual

administration sets are not compatible with the SYMBIQ™ Infusion System.

connector, ensure administration set and fluid compatibility.

connector.

Page 13

Warnings and Cautions Chapter 1: Introduction

• In vitro studies suggest that packed red blood cells with unusually high hematocrit be diluted with blood-compatible fluids like 0.9% sodium chloride injection to decrease hemolysis and increase flow rate.

• Before disconnecting a syringe from the CLAVE

, pull the plunger up slightly to avoid spilling fluid. For rigid containers, close the upper slide clamp, open the cassette carriage, remove and invert the cassette (ports down).

• Air bubbles may form in the administration set as result of normal outgassing of dissolved air in the fluid. This may occur if using a chilled solution if the infuser is mounted significantly above the patient when an administration set is used for more than 24 hours, or when using certain fluids known to routinely outgas. In these cases, an air eliminating filter may be used.

• Repeatedly opening and closing the cassette carriage may defeat the proximal air-in-line alarm and may cause a distal alarm requiring repriming.

• SYMBIQ™ administration sets with integral non-blood filters are not for administration of blood, blood products, emulsions, suspensions, or any medications not totally soluble in the solution being administered. These medications may be administered through the lower Yinjection site below the filter or via SYMBIQ™ administration sets with blood filters.

• Administration sets should be changed per CDC guidelines or hospital policy. Ensure administration sets are properly discarded per CDC guidelines or hospital policy

• DO NOT push the cassette carriage closed. Use the LOAD/EJECT button to open and close the cassette carriage.

• If a cassette is manually ejected from a channel, that channel must not be used until it is reset in Biomed mode.

• To protect the patient from equipment error resulting in over-infusion and - where applicable

- in under-infusion refer to the Technical Service Manual and to “Chapter 10: Alarm and

System Messages” on page 145 and “Appendix B: Alarm Messages and Troubleshooting” on page 199.

• The syringe container size must be between 1 mL and 60 mL. DO NOT use syringe containers larger than 60 mL with the syringe holder adapter.

• Use a vented syringe adapter to assure accurate delivery and reduce the risk of an occurrence of proximal occlusion.

• DO NOT operate or store a SYMBIQ™ Infusion System with the cassette carriage opened. To avoid damaging the cassette carriage, keep it securely closed while the infuser is not in use.

• Accuracy of medication amounts recorded in the logs are dependent on the fill accuracy of IV container and amount discarded during priming.

• Programming a Piggyback VTBI less than the actual container volume results in the remaining volume being delivered at the primary rate after the completion of the Piggyback Program.

• Incorrect selection of proximal occlusion setting may result in a delayed proximal occlusion alarm and under delivery.

SYMBIQ™ Infusion System Operating Manual 9

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Chapter 1: Introduction Warnings and Cautions

Battery Operation Cautions

• The battery may not be fully charged upon receipt. Connect the infuser to AC power for at least four hours prior to initial use. Failure to fully charge the battery may significantly reduce battery life.

• Before connecting a patient to the infuser, ensure the infuser has a fully charged battery installed for continuous infuser operation.

• If the low-battery alarm activates, connect the infuser to AC power immediately.

• Use AC power as the primary power source whenever possible. Before use, inspect the AC cord to check for defects. Connect to AC power during storage to ensure a fully charged battery for emergencies. If the quality of the earth grounding source is in doubt, DO NOT use the infuser on AC power, use only battery power.

Unintended Bolus Delivery

• To avoid delivering a bolus when a distal occlusion is cleared, disconnect the tubing from the patient while eliminating a distal occlusion.

Cleaning Cautions

• To avoid mechanical or electronic damage, DO NOT immerse the SYMBIQ™ Infusion System in fluids or cleaning solutions. DO NOT spray cleaning solutions in or near infuser openings. DO NOT allow cleaning solutions to saturate the air-in-line detectors or enter the infuser when cleaning the air-in-line detectors.

• USE ONLY the recommended cleaning solutions and follow the manufacturer’s recommendations. Using cleaning solutions not recommended by Hospira may result in product damage. The disinfecting properties of cleaning solutions vary; consult the manufacturer for specific information. See “Chapter 12: Cleaning, Maintenance, and

Storage” on page 171.

• DO NOT use compounds containing combinations of isopropyl alcohol and dimethyl benzyl ammonium chloride.

• NEVER use sharp objects such as fingernails, paper clips, or needles to clean any part of the infuser.

• DO NOT sterilize by heat, steam, ethylene oxide (ETO), or radiation.

• DO NOT use abrasive scrub pads or brushes on the scratched or damaged. Use only soft cloths or sponges.

LCD TOUCH SCREEN as it may become

10 SYMBIQ™ Infusion System Operating Manual

Page 15

US FCC (Federal Communications Commission) Chapter 1: Introduction

US FCC (Federal Communications Commission) Statement

This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause interference, and (2) This device must accept any interference, including that which may cause undesired operation of these devices.

FCC Interference Statement

• This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses, and can radiate radio frequency energy. If not installed and used in accordance with the instructions, it may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try and correct the interference by one or more of the following measures:

- Reorient or relocate the receiving antenna.

- Increase the distance between the equipment and the receiver.

- Connect the equipment to an outlet on a different circuit from the circuit the receiver is connected.

- Consult the dealer or an experienced radio/TV technician for help.

• Changes or modifications not expressly approved by Hospira could void the user's authority to operate the equipment.

Wireless Device Caution

• The wireless 802.11 a/b/g device usage in the 5150-5250 MHz band is limited to indoor use to reduce potential for harmful interference to co-channel mobile satellite systems.

• In the 5250-5350 MHz and 5650-5850 MHz frequency bands, high power radars are allocated as primary users and these radars could cause interference and/or damage to LELAN devices.

• Operation is subject to the following two conditions: (1) the wireless device may not cause interference, and (2) the wireless device must accept any interference, including interference that may cause undesired operation of the wireless device.

SYMBIQ™ Infusion System Operating Manual 11

Page 16

Chapter 1: Introduction US FCC (Federal Communications Commission) Statement

Radio Frequency Exposure Statement

• The Wireless LAN radio device in the Connectivity Engine peripheral board with this infusion device has been evaluated and found compliant to the requirements of the following Radio Frequency exposure standards:

- Federal Communications Commission, OET Bulletin 65 (Edition 97-01), Supplement C (Edition 01-01), Evaluating Compliance with FCC Guidelines for Human Exposure to Radio frequency Electromagnetic Fields, July 2001.

- Industry Canada, Evaluation Procedure for Mobile and Portable Radio Transmitters with respect to Health Canada's Safety Code 6 for Exposure of Humans to Radio Frequency Fields, Radio Standards Specification RSS-102 Issue 1 (Provisional): September 1999.

• The radiated output power of this Wireless LAN device is far below the FCC radio frequency exposure limits. The Wireless LAN device has been evaluated with zero inches of human body separation from the antenna and found to be compliant with FCC RF exposure limits.

Electrical Artifacts in Clinical Settings

The SYMBIQ™ Infuser has been tested and found to comply with EMC/EMI limits in accordance with:

• The use of portable and mobile RF equipment may have an impact on this and other pieces of medical equipment

• Nonhazardous, low-level electrical potentials commonly occur when fluids are administered using infusion devices. These potentials are well within accepted safety standards but may create artifacts on voltage-sensing equipment such as ECG, EMG, and EEG machines. If the monitoring equipment is not operating correctly or has loose or defective connections to its sensing electrodes, these artifacts may be accentuated to the point of simulating actual physiological signals. To determine if the abnormality in the monitoring equipment is caused by the infusion device instead of some other source in the environment, temporarily suspend fluid delivery (a therapy should only be suspended if doing so does not pose a clinical risk to the patient). Disappearance of the abnormality indicates it was probably caused by the electronic noise generated by the infusion device. Proper setup and maintenance of the monitoring equipment should eliminate the artifact. Refer to the appropriate monitoring equipment system documentation for setup and maintenance instructions.

• The SYMBIQ™ Infusion System is designed to operate around normally encountered electromagnetic interference (EMI) conditions. If extreme levels of interference like that produced by an electrosurgical generator are encountered, normal operation of a sensor or microcomputer might be disrupted.

• This equipment has been tested and found to comply with EMC/EMI limits in accordance with IEC/EN 60601-1-2 (2001). These limits are designed to provide reasonable protection against harmful interference in a typical medical installation. The equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to other devices in the vicinity. However, there is no guarantee that interference will not occur in a particular installation. If this equipment

12 SYMBIQ™ Infusion System Operating Manual

Page 17

US FCC (Federal Communications Commission) Chapter 1: Introduction

does cause harmful interference with other devices, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:

- Reorient or relocate the receiving device

- Increase the separation between the equipment

- Connect the equipment into an outlet on a circuit different from that to which the other device is connected

- Consult the manufacturer or field service technician for help

• The use of portable and mobile RF equipment may have an impact on this and other pieces of medical equipment.

• Use of radio frequency emitting devices (other than the wireless communication module if installed in the SYMBIQ™ Infuser) such as cellular telephones and 2-way radios in close proximity of this device may affect its operation. Take the following measures to correct interference caused by these devices:

- Relocate or re-orient other radio frequency emitting devices

- Increase the distance between the infuser and other radio frequency emitting devices

- DO NOT connect other radio frequency emitting devices to the same AC power source used by the infuser

SYMBIQ™ Infusion System Operating Manual 13

Page 18

Chapter 1: Introduction US FCC (Federal Communications Commission) Statement

NOTES:

14 SYMBIQ™ Infusion System Operating Manual

Page 19

Chapter 2: Infuser Overview

Chapter 2 describes the SYMBIQ™ Infusion System layout (front, rear, and bottom), infuser

buttons and touchscreen buttons, touchscreen icons & symbols, and infuser features.

Many features of the SYMBIQ infuser system are configurable through Hospira MedNet Meds™ software. For facility-defined configuration details, contact the facility software administrator.

Infuser Layout—Front

Figure 1 depicts the front of both a one- and two-channel SYMBIQ™ Infusion System and the

infuser touchscreen.

/EJECT

LOAD

0mL/hr 0mL

Bolus

Basic

Infusion

Weight

70 kg

BSA

Dose

Rate

(Calculated)

VTBI

Time

(Calculated)

Clear

Press fields to edit. Clear to delete all entries. Options to edit program settings. Next to continue.

Settings Logs

Mode

08:47 PM

Basic

Select Infusion

DOPamine

[400 mg / 250 mL]

13.1

103

07:51

--:--

OptionsClear

Options

STOP

ICU

Advanced

mcg / kg / min

mL / hr

hh:mm

Cancel

Titration

LockStandby

Piggyback

Next A

Alarm

STOP

LOAD

/EJECT

0mL/hr 0mL

Basic

Bolus

Basic

Infusion

Select Infusion

DOPamine

Weight

70 kg

BSA

Dose

Rate

13.1

(Calculated)

VTBI

103

Time

07:51

--:--

(Calculated)

OptionsClear

Options

Clear

Press fields to edit. Clear to delete all entries. Options to edit program settings. Next to continue.

Settings Logs

Mode

08:47 PM

ICU

Advanced

[400 mg / 250 mL]

mcg / kg / min

mL / hr

hh:mm

Cancel

Titration

0mL/hr 0mL

LockStandby

LOAD/EJECT

Piggyback

Next A

Alarm

1515

Figure 1: Front View and Touchscreen of the One- and Two- Channel SYMBIQ™ Infuser

Table 2 outlines the buttons and touchscreen elements corresponding to the numbers in Figure 1.

Table 2: Item Number and Corresponding Feature

# Feature # Feature # Feature

1 Distal tubing guide 7 On/Off button 13 Help/status text area

2 Cassette carriage 8 SILENCE button 14 Battery /AC power indicator

3 Cassette loader housing 9 Emergency Stop button 15 Cassette LOAD/EJECT button

4 Channel Identifier tab 10 CCA (Clinical Care Area)/

16 Channel Identifier tab

Patient Information button

5 Proximal tubing guide 11 Channel-level therapy buttons 17 Cassette carriage

6 Cassette LOAD/EJECT button 12 Programming screen

SYMBIQ™ Infusion System Operating Manual 15

Page 20

Chapter 2: Infuser Overview Infuser Layout—Front

Infuser Buttons

Buttons on the infuser casing function in the following manner:

Table 3: Infuser Buttons

Infuser Button Button Appearance

LOAD/EJECT(S)—opens and closes the

cassette carriage

On/Off—turns power on and off

SILENCE—silences a silenceable alarm for a

specified period of time, usually two minutes

Emergency Stop—stops all channels, generates high urgency alarm

/EJECT

LOAD

STOP

Cleaning Lock (label, located on the rear of the infuser)—this label points to the button which activates and deactivates the touchscreen

Touchscreen Buttons

The SYMBIQ™ Infusion System touchscreen allows the user to access and use on-screen buttons and keypads. A membrane covers the LCD display so a single keypress does not cause significant infuser pole movement nor is it mistaken for a double keypress. When an active touchscreen button is pressed, the infuser sounds an audible valid key tone. The touchscreen also accommodates a keypress whether users are wearing wet gloves, dry gloves, or no gloves.

Note: A triple-beep will sound when making entries that are touchscreen errors.

Note: NEVER use sharp objects such as fingernails, pens, pencils, paper clips, or needles to

program the infuser because they may scratch the LCD screen.

16 SYMBIQ™ Infusion System Operating Manual

Page 21

Infuser Layout—Front Chapter 2: Infuser Overview

Touchscreen Button Appearance

The appearance of touchscreen buttons varies depending on their status. A touchscreen button can be either active, depressed, selected, or unavailable. Table 4 depicts how touchscreen buttons appear based on their status.

Table 4: Touchscreen Button Appearance

Touchscreen Button Status Touchscreen Button Appearance

Active

Bolus

Depressed

Bolus

Selected

Bolus

Unavailable

Bolus

Touchscreen Icons and Symbols

Table 5 describes and illustrates the various touchscreen icons and symbols.

Table 5: Touchscreen Icons and Symbols

On-Screen Item Description On-Screen Item Illustration

Waiting icons (display when a keypress requires processing time)

Horizontal navigation arrow buttons

Vertical short scroll bar (up and down arrows scroll a list by one item)

SYMBIQ™ Infusion System Operating Manual 17

Page 22

Chapter 2: Infuser Overview Infuser Layout—Front

Table 5: Touchscreen Icons and Symbols (Continued)

On-Screen Item Description On-Screen Item Illustration

Vertical hot scroll bar - white interior arrows scroll a list by one item; each yellow arrow increases the scrolling increment by one item more than the previous arrow.

Drop-down list field

Select

End-of-list indicator for drop-down lists

CCA/Patient Information button

Infusion running drip icon

Basic program icon

Multistep therapy icon

Intermittent therapy icon

18 SYMBIQ™ Infusion System Operating Manual

Page 23

Infuser Layout—Front Chapter 2: Infuser Overview

Table 5: Touchscreen Icons and Symbols (Continued)

On-Screen Item Description On-Screen Item Illustration

Interchannel Sequence icon

Piggyback icon

Bolus icon

Upper hard limit icon - displays on a channel tab when an upper hard limit is overridden and the program confirmed on that channel.

Lower hard limit icon - displays on a channel tab when a lower hard limit is overridden and the program confirmed on that channel.

Upper soft limit icon - displays on a channel tab when an upper soft limit is overridden and the program confirmed on that channel.

Lower soft limit icon - displays on a channel tab when a lower soft limit is overridden and the program confirmed on that channel.

SYMBIQ™ Infusion System Operating Manual 19

Page 24

Chapter 2: Infuser Overview Infuser Layout—Front

Table 5: Touchscreen Icons and Symbols (Continued)

On-Screen Item Description On-Screen Item Illustration

No rule set icon - displays on a channel tab when a medication with no defined dose or dose rate limits is selected on a channel.

Device Status Bar has two rows. The first row provides user adjustable device settings of Mode, Settings, Logs, Standby, Lock, and Alarm.

The second row displays WiFi Enabled Icon, Time, and Battery Status.

Mode

08:45 AM

Settings

08:45 AM

Settings

Logs

Standby

Lock

Alarm

20 SYMBIQ™ Infusion System Operating Manual

Page 25

Infuser Layout—Rear Chapter 2: Infuser Overview

Infuser Layout—Rear

Figure 2 depicts the rear layout of the two-channel SYMBIQ™ Infusion System.

Figure 2: Rear View and Layout of the SYMBIQ™ Infusion System

Table 6 outlines features on the rear of the infuser corresponding to the numbers in Figure 2.

Table 6: Item Number and Corresponding Feature

Graphic # Feature

1 Pole Clamp Assembly

2 Pole Clamp

3 Release Lever

4 Cleaning Lock

5 Ethernet Port

6 Proximal Tubing Guide

7 Carrying Handle

8 Release Lever

9 AC Power Cord Retention Strap

10 Nurse Callback Jack

11 Locking Mechanism

12 Pole Clamp Knob

13 AC Power Outlet

(Specifically for one additional SYMBIQ™ Infusion System only.)

14 AC Power Cord

15 Battery Compartment Access Door

SYMBIQ™ Infusion System Operating Manual 21

Page 26

Chapter 2: Infuser Overview Infuser Layout—Rear

Rear Infuser AC Power Outlet

The rear infuser AC power outlet on the back of the SYMBIQ™ Infusion System is designed to accommodate one additional SYMBIQ™ Infuser. Never connect more than one additional infuser to the primary infuser when connected to an AC power outlet. Connecting additional infusers may cause an electrical safety hazard. Before use, inspect the AC cord for defects.

For example, consider operating a primary infuser using AC (mains) power with a second infuser attached to it using the rear infuser AC power outlet. DO NOT attach an additional infuser to the rear infuser AC power outlet of the second infuser (Figure 3).

CAUTION: Never connect more than two infusers when using the rear infuser

AC power outlet; connecting more than two infusers may cause an electrical safety hazard.

Figure 3: Incorrect Use of Rear Infuser AC Power Outlet

Instead, attach an additional infuser directly to an AC (mains) power source (Figure 4).

Figure 4: Correct Use of Rear Infuser AC Power Outlet

22 SYMBIQ™ Infusion System Operating Manual

Page 27

Infuser Layout—Underside Chapter 2: Infuser Overview

Wireless Communication

The Wireless Connection Available icon is displayed when the device is receiving a wireless signal. The infuser will connect to the network if a wireless network access point is recognized.

The SYMBIQ™ Infusion System supports wireless communication via an internal wireless communications module and antennae. Use the SYMBIQ™ Infusion System’s wired or wireless connectivity options to communicate with server-based networks or hospital local area networks. Wireless communication to an infuser is direct rather than indirect through another infuser.

The touchscreen displays a wireless enabled icon when the wireless module is active (Figure 5).

Mode

08:45 AM

Settings

Figure 5: Wireless Enabled Icon on Infuser Touchscreen

Logs

Standby

Lock

Alarm

Infuser Layout—Underside

The underside layout of the SYMBIQ™ Infusion System is shown in Figure 6.

Figure 6: Underside View and Layout of the SYMBIQ™ Infusion System

The numbers on the bottom of the infuser shown on Figure 6 correspond to the numbers on Table 7.

Table 7: Item Number and Corresponding Feature

Graphic #Feature Graphic #Feature

1 Battery Compartment Access Door 3 Distal Tubing Guide

2 Cassette Eject Lever

(EMERGENCY USE ONLY)

SYMBIQ™ Infusion System Operating Manual 23

4 Pole Clamp

5 Cassette Eject Lever

(EMERGENCY USE ONLY)

Page 28

Chapter 2: Infuser Overview Infuser Features

Infuser Features

The SYMBIQ™ Infusion System has five levels of features:

• Patient Information button

- Pressing this button accesses

PATIENT INFORMATION SCREEN.

• Channel Tabs

- Pressing Tab A accesses Channel A (blue display).

- Pressing Tab B accesses Channel B (brown display).

Note: This feature only applies to the two- channel.

• Channel Level—accessed by buttons on the infuser touchscreen. Used to select therapies and supplemental deliveries, these features include:

- Bolus—displays the programmed) or the

- Basic—displays the

BOLUS PROGRAMMING SCREEN (if a Bolus therapy is partially or fully BOLUS SELECTION SCREEN (if a Bolus therapy is not programmed)

PROGRAMMING SCREEN

- Advanced—displays the ADVANCED THERAPIES PROGRAMMING SCREEN (if an Advanced therapy is partially or fully programmed) or the

ADVANCED THERAPIES SELECTION SCREEN (if

an Advanced therapy is not programmed)

- Piggyback—displays the

PIGGYBACK PROGRAMMING SCREEN

• Program Level—accessed by pressing Options button, these features include:

- Power Prime—displays the

POWER PRIME SCREEN

- Deliver at End of Infusion—None, KVO, Continue Rate

- KVO Rate—mL/hr

- Delayed Start—displays the Delayed Start Time entry keypad

- Alarm Options—displays alarm options:

- Distal Occlusion

- Proximal Occlusion

- Infusion Complete Callback

- Air-in-Line

- Nearing End of Infusion

Note: Alarm options set for a program apply only to that program.

• Device Level—accessed by buttons at the bottom of the infuser touchscreen. These buttons control device level features including:

- Mode—displays the

BIOMED MODE PASSCODE ENTRY SCREEN

- Settings—displays the SETTINGS MENU SCREEN

- Logs—displays the CLINICAL LOGS MENU SCREEN

- Standby—displays the Standby Options Screen and places the infuser in Standby mode for up to 24 hours until the Start Basic A is pressed

- Lock—displays the

PROGRAM LOCK/UNLOCK PASSCODE ENTRY SCREEN

- Alarm—displays active alarms

24 SYMBIQ™ Infusion System Operating Manual

Page 29

Infuser Features Chapter 2: Infuser Overview

Channel Level Features

Channel level features are accessed via buttons across the top of the touchscreen as depicted in

Figure 7 below. The default channel level screen is the

BASIC PROGRAM SCREEN.

Basic

13.1

103

07:51

--:--

ICU

Advanced

[400 mg / 250 mL]

mcg / kg / min

mL/hr

hh:mm

Cancel

Titration

Piggyback

Next A

LockStandby

0mL/hr

Bolus

Basic

Weight BSA

0mL

Select Infusion

DOPamine

70 kg

Infusion

Dose

Rate

(Calculated)

VTBI

Time

(Calculated)

OptionsClear

Clear

Press fields to edit. Clear to delete all entries. Options to edit program settings. Next to continue.

Mode

08:45 PM

Options

Settings Logs

Alarm

0mL/hr

Bolus

Basic

Weight BSA

0mL

Basic

Select Infusion

DOPamine

70 kg

Infusion

Dose

Rate

(Calculated)

VTBI

Time

(Calculated)

Clear

Press fields to edit. Clear to delete all entries. Options to edit program settings. Next to continue.

Mode

08:45 PM

07:51

OptionsClear

Options

Settings Logs

ICU

[400 mg / 250 mL]

mcg / kg / min

13.1

mL/hr

103

hh:mm

--:--

Advanced

Cancel

Titration

0mL/hr 0mL

Piggyback

Next A

LockStandby

Alarm

Figure 7: Channel Level Features of a One- and Two- Channel Display

Use channel level buttons to access BOLUS, BASIC, ADVANCED, and PIGGYBACK PROGRAMMING SCREENS when available.

Channel Feature Availability

Selecting a channel level feature affects the availability of other channel level features. For example, entering a single value on the BASIC PROGRAM SCREEN deactivates the Advanced button until the Basic program is cleared. Similarly, entering a single value on an ADVANCED PROGRAM SCREEN deactivates the

Basic button until the Advanced program is cleared.

The Piggyback button is only available for a channel with a confirmed Basic program that has a volume to be infused (VTBI) greater than zero.

For more information on programming therapies, see “Chapter 5: Program (Basic) Therapy” on

page 77, “Chapter 8: Advanced Therapies” on page 105, and “Chapter 9: Program Options” on page 127.

SYMBIQ™ Infusion System Operating Manual 25

Page 30

Chapter 2: Infuser Overview Infuser Features

08:45

Logs

Lock

Mode

scree

ed.

0mL/hr

Piggy

ced

Basic

Bolus

ICU

Program Level Features Options

Program level features are accessed on the PROGRAMMING SCREEN shown in Figure 8 below.

0mL/hr

0mL/h 0mL

Power Prime

Deliver at End of Infusion

Bolus

Basic

ICU

Advanced

Advan

Select Amount

KVO

KVO Rate

Delayed Start

--:--

Alarm Options

Distal Occlusion

Press button or field to change. Done to return to previous

screen when finished.

n when finish

Settings Logs

Setting

Mode

08:45 PM

6 psi

Options

Standb

mL/hr

hh:mm

LockStandby

0mL/hr 0mL

Piggyback

bac

Done

Alarm

Program

Level

Features

arm

Figure 8: Program Level Features

Options allow the selection of additional functions and settings. Options are visible on the

OPTIONS SCREEN once the infusion has been started or stopped

. Only Options allowed for the selected therapy and enabled for the CCA are available. For more information on CCAs, see “Clinical Care Areas” on page 158.

The following features are selectable on the

OPTIONS SCREEN:

• Power Prime—moves a selected amount of fluid through the administration set tubing

• Deliver at End of Infusion—displays Deliver at End of Infusion drop-down list

• KVO Rate—displays KVO Rate Numeric Entry keypad

• Delayed Start—delays an infusion for up to 12 hours

• Alarm Options—alarm options include:

- Distal Occlusion

- Proximal Occlusion

- Infusion Complete Callback

- Air-in-line

- Nearing End of Infusion

26 SYMBIQ™ Infusion System Operating Manual

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Infuser Features Chapter 2: Infuser Overview

Device Level Features

Device level features are accessed via buttons across the bottom of the infuser touchscreen (Figure 9).

Basic

13.1

103

07:51

--:--

ICU

Advanced

[400 mg / 250 mL]

mcg / kg / min

mL/hr

hh:mm

Cancel

Titration

0mL/hr

Infusion

08:45 PM

0mL

Bolus

Basic

Select Infusion

DOPamine

Weight BSA

Dose

Rate

(Calculated)

VTBI

Time

(Calculated)

70 kg

OptionsClear

Clear

Press fields to edit. Clear to delete all entries. Options to edit program settings. Next to continue.

Mode

Options

Settings Logs

0mL/hr 0mL

Piggyback

Next A

LockStandby

Figure 9: Device Level Features

Device level buttons are used to access the following features:

Alarm

Device Level

Features

• Mode—displays the BIOMED MODE PASSCODE ENTRY SCREEN—if not in Delivery Mode and no other device-level button is currently selected

• Settings—adjusts key press and alarm volumes, screen brightness, time mode settings, and

FAR DELIVERY SCREEN

• Logs—displays clinical logs including:

- Program Totals

- Shift Totals

- Logs

- Event Log

- Alarm Log

- Rule Set Alert Override Log

For more information on Logs, refer to “Chapter 11: Stored Data” on page 157.

• Standby—places the infuser in Standby mode for up to 24 hours until the

Basic B

• Lock—displays the

is pressed. for additional information see “Standby:” on page 32.

PROGRAM LOCK/UNLOCK PASSCODE ENTRY SCREEN.

Start Basic A or Start

• Alarm——displays active alarms. For more information see “Chapter 10: Alarm and

System Messages” on page 145.

SYMBIQ™ Infusion System Operating Manual 27

Page 32

Chapter 2: Infuser Overview Infuser Features

Settings

Use the settings button to access and adjust the infuser settings:

• Sound Volume—keypress volume, alarm volume, and test alarm

• Brightness—screen brightness

• Date & Time—time mode settings

• Far Delivery Screen — select VTBI or Volume Infused to display on the

FAR VIEW SCREEN

To access Settings:

1. From any infuser screen, locate and press Settings to display the SETTINGS SCREEN.

Mode

08:45 AM

Settings

Logs

Figure 10: Settings Button

Standby

Lock

Alarm

2. On the SETTINGS SCREEN, press the desired setting.

Settings

Sound Volume

Brightness

Date & Time

Far Delivery Screen

Exit

Figure 11: Settings Screen

28 SYMBIQ™ Infusion System Operating Manual

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Infuser Features Chapter 2: Infuser Overview

To adjust the Sound Volume settings:

1. On the SETTINGS SCREEN, press the Sound Volume button to display the SETTINGS: SOUND VOLUME

SCREEN. See Figure 12 below.

2. On the Settings:

SOUND VOLUME SCREEN, press the Key Press Volume or Alarm Volume buttons to

adjust volume levels. The infuser sounds a tone for the selected volume level.

Settings: Sound Volume

Key Press Volume

Alarm Volume

Test Alarm

Urgency

Cancel

Low

Medium Urgency

High

Urgency

Save

Figure 12: Settings: Sound Volume Screen

Note: Key Press Volume sets the volume for both valid and invalid key presses.

3. When finished adjusting settings on the Settings: SOUND VOLUME SCREEN, press Save.

4. Other Settings:

Sound Volume screen buttons do the following:

- Low Urgency—press button for Low Urgency alarm tone at the current level

- Medium Urgency—press button for Medium Urgency alarm tone at the current level

- High Urgency—press button for High Urgency alarm tone at the current level

5. Press

6. Press

7. On the

Cancel to exit without saving changes. Press Save to exit and retain settings.

Exit to return to the previous screen. See Figure 11: "Settings Screen" on page 28.

SETTINGS SCREEN, press Exit to return to the screen from which the SETTINGS

SCREEN was accessed.

Settings

Sound Volume

Brightness

Date & Time

Far Delivery Screen

Exit

Figure 13: Settings Screen

Note: If no keys are pressed for two consecutive minutes, the SETTINGS SOUND VOLUME SCREEN

reverts to the screen from which the

Settings button was pressed.

SYMBIQ™ Infusion System Operating Manual 29

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Chapter 2: Infuser Overview Infuser Features

To Adjust Screen Brightness:

1. On the SETTINGS SCREEN, press Brightness to display the SETTINGS BRIGHTNESS SCREEN. See Figure 14 below.

2. On the

SETTINGS BRIGHTNESS SCREEN, adjust the screen brightness by pressing Brightness buttons.

The infuser increases or decreases screen brightness to the selected level.

3. When finished adjusting settings on the Settings:

4. Select

Yes or No from the Automatically Dim Backlight when on AC? drop-down menu. Selecting Yes dims

the back light when on AC power. Selecting

BRIGHTNESS SCREEN, press Save.

No, the backlight remains on when on AC. If

operating on battery power, the backlight automatically dims to conserve power.

5. Press

Cancel to return to the SETTINGS MENU SCREEN without saving changes.

Settings: Brightness

Brightness

Automatically dim backlight when on AC?

Yes

Cancel

Figure 14: Settings Brightness Screen

Save

Note: If no keys are pressed for two consecutive minutes, the SETTINGS: BRIGHTNESS SCREEN

reverts to the previous screen.

6. On the

SETTINGS SCREEN, press Exit to return to the previous screen. See Figure 11: "Settings

Screen" on page 28.

30 SYMBIQ™ Infusion System Operating Manual

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Infuser Features Chapter 2: Infuser Overview

To Access Date & Time Settings:

1. On the SETTINGS SCREEN, press Date & Time to display the Settings: DATE & TIME SCREEN. See

Figure 15 below.

2. Press the

Time Format field to specify 12-hour or 24-hour clock formats. Select the desired time

format button on the drop-down list.

Settings: Date & Time

Month

Day

Year

Time Format

Time

Nov

2006

12 Hour

08:47

Cancel

Figure 15: Settings: Date & Time Screen

Save

3. When finished adjusting settings on the Settings: DATE & TIME SCREEN, press Save. Press Cancel to return to the

4. On the

SETTINGS SCREEN, press Exit to return to the screen from which the Settings screen was

SETTINGS MENU SCREEN without saving changes.

accessed. See Figure 11: "Settings Screen" on page 28.

Note: If no keys are pressed for two consecutive minutes, the Settings: Date & Time screen

reverts to the previous screen.

To Access Far Delivery Screen:

1. On the SETTINGS SCREEN, press Far Delivery Screen.

2. Press Displayed Parameter field and select VTBI or Volume Infused from the menu.

Settings

Sound Volume

Brightness

Date & Time

Far Delivery Screen

Exit

3. The selected option is displayed on the

SYMBIQ™ Infusion System Operating Manual 31

FAR VIEW SCREEN.

Page 36

Chapter 2: Infuser Overview Infuser Features

Logs

To access Logs:

1. From any infuser screen, locate and press Logs to display the SHIFT TOTALS and LOGS information.

Mode

08:45 AM

Settings

Logs

Standby

Lock

Log Button

Alarm

The SYMBIQ™ Infusion System collects and stores data available for on-screen viewing. Types of data stored by the infuser and viewable in Clinical mode are Shift Totals and Logs. See the following “Shift Totals Data” on page 162, “Event Log” on page 163, “Alarm Log” on page 164, and “Rule Set Alert Override Log” on page 165 for more information.

Standby:

Standby is a feature that enables the clinician to program the infuser up to 23: 59 minutes in advance of Starting an infusion. While the infuser is in the standby mode, the infuser is powered on and the alarms are disabled.

32 SYMBIQ™ Infusion System Operating Manual

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Infuser Features Chapter 2: Infuser Overview

To access Standby:

1. From any infuser screen, locate and press Standby.

Mode

08:45 AM

Settings

Logs

Standby

Lock

Alarm

Standby Button

2. From the Standby display screen select the channel to be placed in Standby by selecting the appropriate button. When the button is selected, the channel will go into

0mL/hr

13.1 mL / hr

DOPamine

0mL

96.1 mL

[400 mg / 250 mL]

Dose

Standby A

mcg/kg/min

Rate

Standby B

13.

Standby Both

mL / hr

VTBI

Exit

Press Button to enter Standby. Exit to return to previous screen.

96.

ICU

IV Fluid

Standby

Rate

VTBI

75 mL / hr

1000 mL

mL / h

1000

IV Fluid

STANDBY MODE.

Mode

08:47 AM

Settings Logs

Standby

Lock

Alarm

To remove from standby, select the desired channel tab.

Program Lock

An active program lock prohibits changes to any touchscreen field or parameter related to a therapy program including:

• Programming buttons

• Date & Time settings

The program lock is ALWAYS available unless the Cleaning Lock is active, a system message is active, or the infuser is in an active alarm state.

A therapy cannot be started or stopped while the program lock is active using on-screen buttons. Pressing program lock active, the user can access the following infuser features:

SYMBIQ™ Infusion System Operating Manual 33

Emergency Stop will stop the infuser but does not deactivate the program lock. With the

Page 38

Chapter 2: Infuser Overview Infuser Features

1. Screen navigation

2. Brightness and volume control

3. Logs and program parameters

4. Emergency Stop button

5. View shift/program totals

With the Program Lock active, program-related fields and related features are not available. To access program-related fields and features you must first de-activate the Program Lock.

To activate the Program Lock:

1. From any infuser screen, locate and press Lock to display the Enter Code dialog box.

Basic

ICU

Advanced

13.1 mL / hr

13.1 mL/hr

DOPamine

103 mL

Bolus

A: DELIVERING BASIC

DOPamine

[ 400mg / 250 mL]

Dose: 5mcg/kg/min

Rate:

Time Remaining: 07:51 hh:mm

VTBI: 103 mL Volume Infused: 0.4 mL

Stop Basic

Press Stop to end Infusion. Basic button to edit program.

Mode

08:47 PM

Settings Logs

75 mL/hr

1000 mL

Piggyback

LockStandby

IV Fluid

Alarm

Figure 16: Accessing the Program Lock

Lock

34 SYMBIQ™ Infusion System Operating Manual

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Infuser Features Chapter 2: Infuser Overview

2. On the Enter Code dialog box, use the touchscreen keypad to key in a valid passcode, and then press

Enter. Press Cancel to return to the previous screen.

13.1 mL/hr

DOPamine

103 mL

Bolus

A: DELIVERING BASIC

DOPamine

[ 400mg / 250 mL]

Dose: 5 mcg / kg / min

Rate:

Time Remaining: 07:51 hh:mm

Unlocking the Infuser will allow the user to change program-related settings.

VTBI: 103 mL Volume Infused: 0.4 mL

ICU

Basic

Enter Code

Advanced

13.1 mL / hr

Stop Basic

Cancel

Press Stop to end Infusion. Basic button to edit program.

Mode

08:47 PM

Settings Logs

Figure 17: Enter Code Dialog Box (Activating)

Note: See authorized facility personnel for passcode.

75 mL/hr

1000 mL

Piggyback

LockStandby

IV Fluid

Keypad

Enter

Alarm

3. The screen from which the program lock was accessed displays with the program lock activated.

Mode

Settings

Logs

Standby

Lock

Figure 18: Program Lock Activated

Lock

Alarm

Note: Entering an invalid passcode three consecutive times activates the Invalid Passcode

system message for each attempt. Entering an invalid passcode a fourth time closes the Enter Code dialog box and displays the screen from which the program lock was accessed without activating the program lock.

SYMBIQ™ Infusion System Operating Manual 35

Page 40

Chapter 2: Infuser Overview Infuser Features

To deactivate the Program Lock:

1. From any infuser screen, locate and press Lock to display the Enter Code dialog box.

2. At the Enter Code dialog box, use the touchscreen keypad to key in a valid passcode, and then press Enter. Press Cancel to return to the previous screen.

13.1 mL/hr 103 mL

DOPamine

Bolus

A: STOPPED BASIC

DOPamine

[ 400mg / 250 mL]

Dose: 5mcg/kg/min

Rate:

Time Remaining: 07:51 hh:mm

Activating the program lock will prohibit the user from changing program-related

VTBI: 103 mL

settings.

Volume Infused: 0.4 mL

ICU

Advanced

Basic

Enter Code

13.1 mL / hr

Stop Basic

To activate program lock, Press buttons for passcode; then Enter. Cancel to exit.

Mode

08:47 PM

Cancel

Settings Logs

Figure 19: Enter Code Dialog Box (Deactivating)

75 mL/hr

1000 mL

Piggyback

LockStandby

IV Fluid

Enter

Alarm

3. The screen that the program lock was accessed displays with the program lock deactivated.

Basic

ICU

Advanced

13.1 mL / hr

13.1 mL/hr 103 mL

DOPamine

Bolus

A: DELIVERING BASIC

DOPamine

[ 400mg / 250 mL]

Dose: 5 mcg / kg / min

Rate:

Time Remaining: 07:51 hh:mm

VTBI: 103 mL Volume Infused: 0.4 mL

Stop Basic

Press Stop to end Infusion. Basic button to edit program.

Settings Logs

Mode

08:47 PM

Figure 20: Program Lock Deactivated

75 mL/hr

1000 mL

Piggyback

LockStandby

IV Fluid

Lock

Alarm

Note: Entering an invalid passcode three consecutive times activates the Invalid Passcode

36 SYMBIQ™ Infusion System Operating Manual

Page 41

Chapter 3: Infuser Operations

Chapter 3 describes the basic operations of the SYMBIQ™ Infusion System. This includes a discussion of power on, power down, programming a therapy, and delivering a therapy.

Infuser Operations Overview

The infuser has four basic operations divided into four segments: power on, program, deliver and stop.

• Power—to power on and power off the infuser

• Programming—to program the following therapies:

- Bolus

-Basic

- Advanced (Multistep Interchannel Sequencing and Intermittent)

- Piggyback

• Delivery—to observe and monitor the progress of an infusion

• Stop—to stop infusion

Power Modes

The Power mode is used to power on and power off the infuser.

AC Power

When attached to an AC power source, the SYMBIQ™ Infusion System uses AC power regardless of the level of available battery power. Use AC power whenever possible, the battery is intended as a backup or emergency power source. However, if the quality of the earth grounding source is in doubt use battery power.

Before initial use, connect the infuser to AC power for at least four hours to ensure the battery is fully charged. Whenever connected to an AC power source, the infuser charges the battery.

If one channel of a two-channel infuser fails a self-test, the other channel remains available.

SYMBIQ™ Infusion System Operating Manual 37

Page 42

Chapter 3: Infuser Operations Power Modes

To power on the infuser:

1. Ensure the infuser is securely attached to an I.V. pole and connected to an AC power source.

2. Press and hold the

On/Off button for one second, then release.

LOAD/ EJECT

STOP

LOAD

/EJECT

Figure 21: On/Off Button

3. At power on, the STARTUP SCREEN displays during diagnostic self-tests.

SYMBIQ

Infusion System

Software Version

X.XX

Drug Library Version

X.XX

Medical Center

November 1, 2006

08:47 AM

PLEASE WAIT

WHILE PUMP INITIALIZES

Figure 22: Infuser Startup Screen

38 SYMBIQ™ Infusion System Operating Manual

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Power Modes Chapter 3: Infuser Operations

The diagnostic self-tests take about ten seconds to complete. Once diagnostic self-tests complete, a

STARTUP SCREEN indicates whether any program, patient, distal and proximal occlusion, or air-in-

line sensitivity settings were saved. At power on, the default active channel is A. Pressing the appropriate channel tab accesses that channel.

CAUTION: DO NOT place the SYMBIQ™ Infuser in service if it fails any of the

diagnostic self-tests.

Channel LEDs

During diagnostic self-tests, the channel LEDs located just above the cassette carriage (Figure 23) flash green once, yellow once, and red once.

Channel LED

Cassette Car

riage

Figure 23: Channel LED Location

Table 8 outlines channel LED color and the conditions under which the channel LEDs illuminate.

During an alarm state, the color and flashing characteristics of both the channel LED and channel alarm tab are the same.

Table 8: Channel LED Color and Conditions

Channel LED Color Conditions

Solid Green While in Delivery mode and delivery has not been

interrupted.

Flashing Green When the cassette carriage is either opening, closing, or

open, and during power priming.

Solid Yellow During a Low urgency alarm condition.

Flashing Yellow During a Medium urgency alarm condition.

Flashing Red During any High urgency alarm condition.

Solid Red During a latched High urgency alarm condition. A latched

High urgency condition notifies the user of a previous alarm condition—which no longer exists—until the alarm is cleared by the user.

SYMBIQ™ Infusion System Operating Manual 39

Page 44

Chapter 3: Infuser Operations Power Modes

If the infuser has been powered off for less than five hours, previous patient information, program information, and infuser settings are retained. The New Patient dialog box displays over the

STARTUP SCREEN. See Figure 24 below.

Selecting No in the New Patient field and pressing Continue retains stored patient and program information and displays the

STARTUP SCREEN. The STARTUP SCREEN shows infuser status and

provides access to view both patient and program information. Selecting Ye s in the New Patient field and pressing

PATIENT INFORMATION SCREEN.

Continue clears stored patient and program information and displays a blank

New Patient?

100

New Patient?

Clear Shift Totals?

View

SolutionSolution

Solution

Patient Info

100

Yes

1:40

Air Sensitivity:

Yes

Continue

Figure 24: New Patient Dialog Box

When a Drug Library contains one or more Clinical Care Areas (CCAs), the user must specify a CCA at power on. When prompted, either confirm the current CCA or select a new one.

NICU

ICU

Recovery

Nursery

Cancel

Figure 25: Specifying a CCA

40 SYMBIQ™ Infusion System Operating Manual

Page 45

Power Modes Chapter 3: Infuser Operations

Battery Power

For either a one-or two-channel infuser, the battery provides approximately four hours of power at 125 mL/hr while on battery power and with the LCD backlight at Power Saving mode.

The non-volatile battery life is sufficient to retain program parameters, delivery totals, patient information (ID, weight, and height), clinician information, and logs.

CAUTION: Before use, ensure the infuser has a functional battery installed. Use

of a properly installed and functional battery helps ensure the infuser operates properly.

The battery indicator icon is located in the lower right corner of the touchscreen. Table 9 shows battery indictor icons and the associated battery life, power level, and alarm state for each indicator icon. When the infuser is attached to an AC power source, the battery indicator icon shows the current battery charge level.

Table 9: Battery Indicator Icons

Battery Indicator Icon

Battery Indicators when infuser is operating on battery power

Battery icon location:

Power Level

Alarm State

Battery

Mode

08:45 AM

Settings

Logs

Standby

Lock

Alarm

icon

Note: Icon is located in the lower right corner of the device level area.

Full (76%-100%) None

Three-quarters (51%-75%) None

Half (50%)

None

Note: This indicator displays when the battery is at

half capacity—until the activation of the 30-min. Low battery Alarm (see next indicator) when the infuser is operating on battery power:

30 minutes Low

15 minutes Medium

5 minutes

High

Note: Depleted Battery Alarm occurs at this stage.

The AC cord needs to be immediately plugged in. Infuser is about to shut down.

SYMBIQ™ Infusion System Operating Manual 41

Page 46

Chapter 3: Infuser Operations Power Modes

Table 9: Battery Indicator Icons (Continued)

Battery Indicator Icon

DC_icon_Bat_Empty.ep

Charging Battery Indicators when infuser is operating on AC Power

Power Level

Empty

Note: A flashing battery indicator shall alternate

between the two battery icons illustrated on the left.

AC power (infuser using AC power only, battery charged to 90% or more capacity)

Charging, capacity at 75% or greater but less than 90% capacity None

Charging, capacity at 50% or greater but less than 75% capacity None

Charging, capacity at 25% or greater but less than 50% capacity None

Displays when the infuser is powered on and no battery above the Depleted Battery threshold is detected.

Alarm State

None

At the first Low Battery alarm, the battery has only enough charge remaining to continue the current delivery rate for approximately 30 minutes. A Low Battery alarm also occurs when only 15 minutes of battery life remains at the current infusion rate. A Depleted Battery alarm will occur when the remaining battery life is approximately 5 minutes or less. The Depleted Battery alarm will continue until there is no power remaining. The infuser will then stop and shut down. At this point a backup buzzer will sound for about two minutes. Immediately connect the infuser to AC power when a Low or Depleted alarm sounds to assure the infusion continues.

Note: As long as a low battery condition exists, the Low Battery alarm cannot be cleared, but it

may be minimized by pressing the alarm tab.

DO NOT use a SYMBIQ™ Infusion System without a properly functioning battery installed. If no battery is detected at power on, the Service Battery alarm activates (Figure 26). In this case, remove the infuser from service until a properly functioning battery can be installed.

42 SYMBIQ™ Infusion System Operating Manual

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Power Modes Chapter 3: Infuser Operations

When approximately 5 minutes of battery life remain, the infuser sounds and displays a high urgency alarm. Immediately connect the infuser to AC Power. The infuser will stop and shut down.

0mL/hr 0mL

No Back-up Battery

In the event of A/C power loss, infusion will stop.

0mL/hr 0mL

OK to acknowledge.

Press

SERVICE BATTERY

Battery should be replaced. No battery back-up. In the event of A/C power loss,

Settings Logs

Mode

infusion will stop. Replace battery soon.

08:47 AM

Press here to minimize all alarms.

LockStandby

00:00:09

Alarm

Figure 26: Service Battery System Message

CAUTION: Before use, ensure the infuser has a functional battery installed. Use

of a properly installed and functional battery helps ensure the infuser operates properly.

A/C Power LED

The A/C power LED (Figure 27) is located on the front of the infuser just above the On/Off and

Emergency Stop buttons. When using AC power with a fully-charged battery, the A/C power LED is

lit green. When using A/C power with the battery charging, the A/C power LED flashes. When using battery power only, the power LED is off.

Figure 27: Location of A/C Power LED

SYMBIQ™ Infusion System Operating Manual 43

Page 48

Chapter 3: Infuser Operations Programming Mode

Touchscreen Visibility

If no keystrokes or button presses are made for a CCA-defined period of time (the default is two minutes), the infuser enters Power Saving mode. Power Saving mode is marked by an 80% reduction in touchscreen brightness.

Turning touchscreen away from direct sunlight improves visibility. Any infuser alarm state or pressing the touchscreen restores brightness to normal levels.

Power Off

When power is removed from the infuser, it enters Power Down mode. If open, close the cassette carriage. During a normal power down, all critical data is saved to the appropriate logs, the current program and all user-configured settings are retained. All alarm sensitivity settings are also retained at power down.

To power down the infuser:

1. Ensure all infusions are stopped and the infuser is not in Delivery mode.

2. Press and hold the

Figure 21: "On/Off Button" on page 38.

Note: If the infuser is powered off before completing or confirming a program, the partially

entered program is cleared the next time the infuser is powered on.

On/Off button for one second, and then release. The infuser powers off. See

Programming Mode

Programming mode is used to program infusion therapies. Therapies and supplemental deliveries available in programming mode include:

• Bolus

•Basic

• Advanced

• Piggyback

44 SYMBIQ™ Infusion System Operating Manual

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Delivery Mode Chapter 3: Infuser Operations

Basic Mode

From this screen, the user can access these features:

• Patient Information Button—displays patient information

• Channel Tabs—displays the channel screen (only one channel displays at a time) Press the channel tab to select it. The selected channel tab appears in 3-D

• Bolus—displays the

BOLUS PROGRAM SCREEN (Bolus button available before and after a primary

infusion is programmed on the active channel)

• Advanced—displays the

ADVANCED THERAPY SELECTION SCREEN

• Piggyback—displays the PIGGYBACK PROGRAM SCREEN (Piggyback button unavailable until a primary infusion is programmed on the active channel)

• Clear—if not in Delivery mode, removes all values entered on a programming screen

• Options—displays the

OPTIONS SCREEN

• Cancel Titration—(if accessing the BASIC PROGRAM SCREEN to titrate the therapy) cancels all changes made to the program

• Next A —Displays the Confirm

PROGRAM SCREEN available only when all required program

parameters have been entered

• Next B —Displays the Confirm

PROGRAM SCREEN available only when all required program

parameters have been entered

• Device Level Buttons—displays device level features

Delivery Mode

Two types of screens display during Delivery mode—Near Viewing and Far Viewing. A NEAR

IEWING DELIVERY SCREEN is shown in Figure 28 below.

Basic

ICU

Advanced

13.1 mL / hr

13. 1 mL/hr 103 mL

DOPamine

Bolus

A: DELIVERING BASIC

DOPamine

[ 400mg / 250 mL]

Dose: 5mcg/kg/min

Rate:

Time Remaining: 07:51 hh:mm

VTBI: 103 mL Volume Infused: 0.4 mL

Stop Basic

Press Stop to end Infusion. Basic button to edit program.

Mode

08:47 PM

Settings Logs

75 m L/hr

1000 mL

Piggyback

LockStandby

IV Fluid

Alarm

Figure 28: Near Viewing Delivery Screen

SYMBIQ™ Infusion System Operating Manual 45

Page 50

Chapter 3: Infuser Operations Delivery Mode

The NEAR VIEWING DELIVERY SCREEN displays medication name (if enabled in the selected CCA), concentration, dose rate (if applicable), time remaining, VTBI, volume infused, infusion status for advanced therapies, and alarm name for the highest priority alarm if in an alarm state. On the

NEAR VIEWING DELIVERY SCREEN, both VTBI and Volume Infused values display with one decimal

place for values up to 100.

Note: The

FAR VIEWING SCREEN displays the medication name (if enabled in the selected CCA),

The

NEAR VIEWING DELIVERY SCREEN displays the Dose label and value if a dose is programmed.

concentration, and if in an alarm state, the alarm name for the highest priority alarm. On the

FAR VIEWING DELIVERY SCREEN, VTBI or volume infused values display with two decimal

places. For values greater than or equal to 100, values display without a decimal.

0mL/hr

13.1 mL / hr

DOPamine

0mL

96.1 mL

[400 mg / 250 mL]

Dose

ICU

IV Fluid

75 mL / hr

1000 mL

IV Fluid

mcg/kg/min

Rate

13.

mL / hr

VTBI

96.

Press Dose, Rate, or VTBI button (When available) to edit. Press Tab A or Tab B to display Near Viewing Delivery screen.

Rate

mL / h

VTBI

1000

Alarm

Settings Logs

Mode

08:47 AM

Figure 29: Far Viewing Delivery Screen

LockStandby

Pressing the LOAD/EJECT button while in delivery mode does not eject the cassette; to eject a cassette, the infuser must be in Stop mode.

Once the infuser completes a programmed therapy, the End of Infusion alarm activates. The infuser transitions to a KVO (Keep Vein Open) delivery rate. Depending on programming, the infuser continues to deliver at programmed rate or transitions to KVO.

46 SYMBIQ™ Infusion System Operating Manual

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Stop Mod e Chapter 3: Infuser Operations

Stop Mode

The SYMBIQ™ Infusion System stops in one of several ways:

• Pressing

Stop Basic A on the touchscreen.

Emergency Stop on the front of the infuser stops all channels.

LOAD/ EJECT

STOP

LOAD

/EJECT

Figure 30: Emergency Stop Button

• An active alarm state will stop the infusion.

• When a programmed VTBI completes and there is no KVO.

• A Bolus is complete and Stop Infusion has been selected on the

When a delivery is manually stopped (by pressing delivered, the

STOP MODE SCREEN shows the A: STOPPED BASIC MESSAGE across the banner

Stop Basic A) and the VTBI has not completely

as in Figure 31.

DOPamine

13.1 mL/hr 102 mL

ICU

75 mL/hr

1000 mL

Emergency

Stop

BOLUS SETUP SCREEN.

IV Fluid

Bolus

A: STOPPED BASIC

A: DELIVERING BASIC

DOPamine

[ 400mg / 250 mL]

Dose: 5 mcg / kg / min

Rate:

Time Remaining: 07:44 hh:mm

VTBI: 102 mL Volume Infused: 1.5 mL

Press Start to resume Infusion. Basic button to view or edit program.

Mode

08:47 AM

Basic

Settings Logs

Advanced Piggyback

13. m

L/hr

Start Basic

LockStandby

Alarm

Figure 31: Stopped Basic Screen—Manual Stop in a Basic Program

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Chapter 3: Infuser Operations Stop Mode

When a therapy is stopped due to an alarm state including Emergency Stop, the STOP MODE SCREEN shown in Figure 32 displays.

DOPamine

13. 1 mL/hr 102 mL

ICU

75 mL/hr

1000 mL

IV Fluid

Bolus

A: STOPPED BASIC

A: DELIVERING BASIC

DOPamine

[ 400mg / 250 mL]

Dose: 5 mcg / kg / min

Rate:

Time Remaining: 07:44 hh:mm

VTBI: 102 mL Volume Infused: 1.5 mL

Press Start to resume Infusion. Basic button to view or edit program.

EMERGENCY STOP

Emergency Stop button pressed. Infusion(s) stopped.

Mode

08:47 AM

Figure 32: Stopped Basic Screen—Alarm State

Basic

Settings Logs

Advanced Piggyback

13. m

L/hr

Start Basic

Press here to clear alarm

LockStandby

Alarm

00:00:09

WARNING: After pressing Emergency Stop, verify that the Emergency Stop

Banner is displayed and delivery has

stopped.

While in Stop mode, the user can

• access the current programmed therapy

• access the lock/unlock functionality

• access programming mode to start a new program or change a current program

• start a programmed therapy or continue the current therapy

• select a new CCA

• update patient information

Note: The

STOPPED BASIC SCREEN only displays the Dose label and value if a dose is

programmed.

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Stop Mod e Chapter 3: Infuser Operations

To stop the infuser using the touchscreen Basic button:

1. If the FAR VIEWING SCREEN is active, you must touch the screen to display the NEAR VIEWING

SCREEN.

2. On the

NEAR VIEWING SCREEN, locate and press Stop Basic A.

13.1 mL/hr

Stop Basic A Button

103 mL

DOPamine

Bolus

A: DELIVERING BASIC

DOPamine

[ 400mg / 250 mL]

Dose: 5 mcg / kg / min

Rate:

Time Remaining: 07:51 hh:mm

VTBI: 103 mL Volume Infused: 0.4 mL

Stop Basic

Press Stop to end Infusion. Basic button to edit program.

Mode

08:47 PM

Basic

Settings Logs

Figure 33: Basic Button

3. To resume infusing, press Start Basic A.

ICU

Advanced

13.1 mL / hr

75 mL/hr

1000 mL

Piggyback

LockStandby

IV Fluid

Alarm

To stop the infuser using the Emergency Stop button:

Note: In an Emergency, use the Emergency Stop button to stop all channels. Otherwise, use Stop Basic A

button

on the touchscreen to stop individual channels.

1. Locate the

Emergency Stop button on the front of the infuser. See Figure 30: "Emergency Stop

Button" on page 47.

2. Press and release

Emergency Stop button. All active programs stop infusing and a high urgency

alarm sounds.

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Chapter 3: Infuser Operations General Programming Guidelines

3. Press Start Basic A on the touchscreen to resume the therapy.

Basic

ICU

Advanced Piggyback

L/hr

13. m

13.1 mL/hr

102 mL

DOPamine

Bolus

A: STOPPED BASIC

A: DELIVERING BASIC

DOPamine

[ 400mg / 250 mL]

Dose: 5 mcg / kg / min

Rate:

Time Remaining: 07:44 hh:mm

VTBI: 102 mL Volume Infused: 1.5 mL

Press Start to resume Infusion. Basic button to view or edit program.

EMERGENCY STOP

Emergency Stop button pressed. Infusion(s) stopped.

08:47 AM

Mode

Settings Logs

Figure 34: Start Basic A Touchscreen Button

75 mL/hr

1000 mL

Start Basic

Press here to clear alarm

LockStandby

00:00:09

General Programming Guidelines

IV Fluid

Alarm

If the infuser is powered off before completing or confirming a program, the partially entered program is cleared the next time the infuser is powered on. If a change is made to a program during an infusion but is neither canceled nor confirmed, a Callback alarm activates.

Calculated Values

A calculated value that either exceeds the current maximum medication delivery rate or the maximum volumetric rate for the selected CCA activates a warning message.

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General Programming Guidelines Chapter 3: Infuser Operations

Invalid Value Handling

If entering a value in a field that exceeds a value limit defined for that field, the following occurs:

• activates the Invalid Entry system message

• sounds the Invalid Key tone

• replaces the value with three dashes (“---”)

There are two types of value limits for a field: maximum field length and maximum field amount.

For fields with defined maximum lengths, entering a four-character value in a field with a threecharacter limit exceeds the length limit for that field and activates the Invalid Entry system message.

Entering an amount that exceeds the defined limit activates the Invalid Entry system message (Figure 35).

13.1 mL / hr 103 mL

DOPamine

Bolus

A: BASIC

Infusion

Weight BSA

Dose

Rate

VTBI

Time

Invalid value entered. Clear to delete entry. Cancel to exit without saving change.

08:47 AM

Cancel

Mode

Weight

Height

BSA

Settings Logs

ICU

Basic

Advanced

DOPamine

[ 400

---

Cancel

Clear

75 mL / hr

1000 mL

Piggyback

1 2 3

4 5 6

7 8 9

Cancel

Enter

Alarm

LockStandby

IV Fluid

Figure 35: Invalid Entry System Message

A field must contain a valid value before exiting. To remove the Invalid Entry system message, press

Clear. Pressing Clear also replaces the three dashes (“---”) in a field with field default values;

either “0” for non-time fields or “--:--” for time fields.

Value Rounding

For calculated values, the infuser truncates the value one digit beyond what the screen can display, and then rounds off the value. If the therapy is based on either a calculated value or a rounded value, the infuser delivers the therapy at the stored value. For example, if the stored value is in hundredths but displays in tenths, the infusion rate has a granularity of hundredths. Stored information does not change. If a stored value contains more decimal places than can be displayed, the infuser rounds the displayed value. The infuser uses the rounding rules based on one digit beyond what can be displayed.

Note: Calculated interim values retain all decimal places supported by the infuser’s hardware.

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Chapter 3: Infuser Operations Biomed Mode

Biomed Mode

Biomed mode is used to perform calibrations and diagnostic tests on the SYMBIQ™ Infusion System. In Biomed mode, a trained and qualified biomedical technician can restore the infuser’s default factory settings and default drug library, configure device settings, and clear all logs and viewable data.

CAUTION: Only qualified biomedical technicians should access the infuser’s

Biomed mode.

Note: Biomed mode is passcode protected.

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Chapter 4: Infuser Preparation

Overview

This chapter describes preparing the SYMBIQ™ Infusion System for use including attaching it to

an I.V. pole; attaching two infusers, preparing administration sets; loading, priming, and removing cassettes; and ejecting a cassette in an emergency.

CAUTION: To prevent product damage, use proper care during unpacking and

installation. DO NOT use a SYMBIQ™ Infusion System if it appears damaged in any way.

Attaching and Removing an Infuser from an I.V. Pole

The SYMBIQ™ Infusion System’s pole clamp mechanism utilizes a quick-travel mechanism for attaching to an I.V. pole. Attach the infuser to a pole by pushing the pole clamp against an I.V. pole, and then turning the pole clamp knob clockwise to secure the infuser in place. To assure a secure attachment, it is helpful to keep the infuser back parallel to the I.V. pole during attachment. Detach an infuser from a pole by turning the pole clamp knob counter-clockwise approximately one-half turn, and then pressing the quick travel release button to retract the pole clamp. See Appendix C for I.V. pole list number.

The following table provides mounting height data:

Table 1: I.V. Maximum Mounting Height of Infusers on a Single I.V. Pole

One

Infuser

inches

Two In f u s e r s

(Vertical, each with their

own pole clamp)

68 inches to infuser #1 58 inches

57 inches to infuser #2

Two Infusers

(Interlocked

using 1” pole clamp)

Note: Measurements are from the ground to the top of the infuser.

CAUTION: To prevent personal injury or product damage, make sure the pole

clamp is tightened properly and the infuser is securely attached. The pole clamp is locked when the mechanism makes a clicking noise.

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Chapter 4: Infuser Preparation Attaching and Removing an Infuser from an I.V. Pole

Infuser Configurations on an I.V. Pole

The user can attach a one- channel infuser or a two channel infuser to an I.V. pole (Figure 36). The infuser can be attached together horizontally; attach additional infuser to the right. (See

"Attaching Two Infusers" on page 57.)

Figure 36: Acceptable Infuser Configurations on I.V. Pole

When attaching a one- channel and two- channel infuser, the one-channel is attached to the I.V. pole

first. A two channel can then be attached on the right side of the one channel.

To attach an infuser to an I.V. pole:

1. Ensure the I.V. pole is correctly assembled, meets Hospira recommendations, and is on a flat surface.

2. Grasp and hold the infuser by the handle, and then place the I.V. pole inside the infuser’s pole clamp.

Figure 37: Placing I.V. Pole Inside Pole Clamp

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Attaching and Removing an Infuser from an I.V. Pole Chapter 4: Infuser Preparation

3. While holding the infuser with one hand, push the pole clamp knob forward against the I.V. pole.

Figure 38: Pushing Pole Clamp Knob Forward against I.V. Pole

4. Turn the pole clamp knob clockwise until the user hears audible clicks to secure the infuser against the I.V. pole.

Figure 39: Turning the Pole Clamp Knob Clockwise

Note: After tightening, push down and pull up to make sure that it is tightly clamped to the

pole without slippage. If not, realign and turn the knob till it clicks.

5. Ensure the infuser is securely attached to the I.V. pole by checking for both vertical and rotational slippage.

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Chapter 4: Infuser Preparation Attaching and Removing an Infuser from an I.V. Pole

To detach an infuser from an I.V. pole:

1. Ensure the administration set is disconnected from the patient before removing an infuser from an I.V. pole.

2. Grasp and hold the infuser by the handle.

Figure 40: Grasping the Infuser

3. While grasping the infuser with one hand, turn the pole clamp knob counterclockwise approximately one-half turn with the other hand.

Figure 41: Turning the Pole Clamp Knob Counter-Clockwise

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Attaching Two Infusers Chapter 4: Infuser Preparation

4. Press the Quick Travel Release button; the pole clamp retracts from the I.V. pole.

Figure 42: Pressing the Quick Travel Release Button

5. With the pole clamp retracted, remove the infuser from the I.V. pole.

Figure 43: Removing Infuser from I.V. Pole

Attaching Two Infusers

When attaching one SYMBIQ™ Infusion System to another, follow these guidelines:

• Infusers can be attached together horizontally. Attach one additional infuser to the right (when facing the front of the infusers) of the primary infuser.

• To attach a one- channel and two- channel infuser, the one-channel is attached to the I.V. pole first. Then attach, the two-channel to the right side of the one-channel.

Note: A one-channel infuser CANNOT be attached to the right (when facing the front of the

infusers) of a two-channel infuser.

• A two-channel infuser can be attached to a second two-channel infuser.

• A one-channel infuser CANNOT be attached to a second one-channel infuser.

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Chapter 4: Infuser Preparation Attaching Two Infusers

To Attach One Infuser to a Second Infuser:

1. When facing the front of the infuser, the right side has a T-slot.

I.V. Pole

T-Slot

Figure 44: T-slot on Right Side of Primary Infuser

2. Ensure the second infuser (the attached infuser) has a tongue on the left.

Tongue

Figure 45: Tongue on Left Side of Secondary Infuser

3. Grasp the second infuser by the handle and place the bottom of the tongue in the opening at the top of the primary infuser’s T-slot.

4. Slide the second infuser down until the tongue latches at the bottom of the primary infuser. Ensure the two infusers are securely attached by

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Attaching Two Infusers Chapter 4: Infuser Preparation

• Checking for both vertical and horizontal slippage

• Visually inspecting the front of the infusers to ensure they are properly aligned

Figure 46: Latching Tongue Inside T-slot

5. Connect the primary infuser to an AC power source. Plug the AC power cord of the second infuser into the back of the primary infuser AC power outlet or into an AC power source. See “Rear Infuser AC Power Outlet” on page 22.

CAUTION: Never connect more than two infusers when using the rear infuser

AC power outlet; connecting more than two infusers may cause an electrical safety hazard.

6. Shown in Figure 48 is a two-channel fully attached to a one-channel.

Figure 47: Two-Channel Fully Attached to a One-channel

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Chapter 4: Infuser Preparation Detaching Connected Infusers

7. When attaching a two infuser array to an I.V. pole, attach the one-channel to the I.V. pole to maintain stability.

Detaching Connected Infusers

To Detach One Infuser from a Second Infuser:

1. Unplug the infuser from the AC power source.

2. Ensure the administration set is disconnected from the patient before detaching.

3. The infuser can be detached in either of the following methods: The infuser not attached to the IV pole can be detached.

• Grasp and hold the infuser by the handle. Pull up on the purple release lever and slide the infuser up until it is disconnected from the primary infuser.

one-channel

two-channel

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Detaching Connected Infusers Chapter 4: Infuser Preparation

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Chapter 4: Infuser Preparation Administration Sets

• Pull the black release lever to the right, and slide the infuser up until it is disconnected from the primary infuser.

Black Release Lever

Figure 48: Grasping the Infuser

Administration Sets

Hospira administration sets are sterile (when in sealed packaging), disposable, and designed for one-time use only. Fluid pathways and surfaces beneath unopened protective covers are sterile and nonpyrogenic in intact packaging marked sterile as shown in Figure 49.

Figure 49: Label Indicating Sterile Parts and Pathways

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Administration Sets Chapter 4: Infuser Preparation

See “Appendix C: Accessories, Administration Sets, and Components” on page 211 for a complete list of compatible Hospira administration sets for the use with the SYMBIQ™ Infusion System.

WARNING: When infusing at low delivery rates (5.0 mL/hr or less), use thick-

walled microbore sets to reduce the amount of the fluid bolus that may be delivered when a distal line occlusion is released.

CAUTION: Administration sets should be changed per CDC guidelines or

hospital policy. Ensure administration sets are properly discarded per CDC or hospital guidelines.

CAUTION: A typical Hospira SYMBIQ™ Lifecare administration set is shown below:

Table 10: Item Number and Corresponding Feature

1 Piercing Pin with drip chamber 6 Distal End of cassette

2 BackCheck Valve 7 Option-Lok®

3 Proximal End of cassette 8 Tubing

4 Cassette 9 CAIR™ Roller Clamp

Flow Stop (open / closed )

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10 Y-site with CLAVE®

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Chapter 4: Infuser Preparation Administration Sets

Preparing Administration Sets

Before attempting to prepare and assemble administration sets, understand the components and proper preparation and assembly techniques. To prevent contamination, use aseptic techniques

with all fluid-path connections. Remove protective coverings as administration set assembly progresses.

WARNING: DO NOT use medications incompatible with silicone rubber or

PVC plastic or medications not stable under infusion conditions.

WARNING: Always prime the administration set to remove air from the

cassette, tubing, and injection sites prior to connecting to the patient. Always disconnect the administration set from the patient prior to priming or purging.

WARNING: Arrange tubing, cords, and cables to minimize the risk of patient

strangulation or entanglement.

CAUTION: USE ONLY Hospira SYMBIQ™ administration sets with the

SYMBIQ™ Infusion System. Use of unauthorized sets may result in injury to the patient or damage to the infuser. Gemstar® administration sets are not compatible with the SYMBIQ™ Infusion System.

CAUTION: When priming is complete and the cassette flow stop is closed,

ensure no fluid flows at the distal end of the administration set. If fluid flow is observed, DO NOT use the administration set.

Fluid Container Compatibility

Fluid containers compatible with the SYMBIQ™ Infusion System include:

• Dual-chamber parenteral flexible container (NutriMix

• Large-volume parenteral flexible containers including premixed

• Large-volume parenteral glass containers including premixed and nutritional that use a vented set

• Part-fill parenteral flexible plastic containers including ADD-Vantage

)

• Part-fill parenteral glass containers that use a vented set

• Ready-to-hang enteral solution containers

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Administration Sets Chapter 4: Infuser Preparation

To prepare an administration set for infusion:

1. Ensure the cassette flow stop, tubing slide clamp, and CAIR roller clamp are closed.

2. Insert the piercing pin into the fluid container outlet with a twisting motion.

3. Hang the fluid container on an I.V. pole.

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Chapter 4: Infuser Preparation Administration Sets

4. Fill the drip chamber one-third full or to the score mark if applicable; DO NOT completely fill the drip chamber.

5. Invert the cassette and all the proximal Y site (if applicable) approximately 45º.

Note: When inverting cassette, purple plastic collar should be on the bottom.

6. Open the cassette flow stop, tubing slide clamp, and CAIR roller clamp.

Note: Tap the Y site and cassette while holding in an inverted position to expel any residual air.

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Administration Sets Chapter 4: Infuser Preparation

7. Return the cassette and the Y sites (if applicable) to the upright position. Continue priming until fluid fills the tubing.

8. Close the cassette flow stop and CAIR roller clamp.

CAUTION: Before using a CLAVE® connector, ensure administration set and

fluid compatibility. Do not use needles to access the CLAVE connector.

To prepare an administration set with a syringe holder adapter:

1. For syringe delivery, use the appropriate Hospira Administration Set with syringe holder adapter, listed in Appendix C.

Note: Refer to the SYMBIQ™ administration sets labels for information regarding use with

different flow rates.

2. Locate the screw hole on the back of LCD display near the handle.

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Chapter 4: Infuser Preparation Administration Sets

3. Insert the ball tip of the syringe holder into the screw hole.

4. Fit the rounded-end of the syringe holder into the adapter hole on the back of the infuser.

CAUTION: Use a vented syringe adapter to assure accurate delivery and reduce

the risk of an occurrence of proximal occlusion.

5. Snap the syringe holder in place on the infuser handle.

6. Attach a luer locking syringe container into the top of the syringe holder adapter.

CAUTION: The syringe size must be between 1 mL and 60 mL. DO NOT use

syringes larger than 60 mL with the syringe holder adapter.

7. Ensure the cassette flow stop, tubing slide clamp, and CAIR roller clamp are open.

8. Ensure the syringe administration set is fully primed before attaching it to a patient.

Note: Prime a syringe administration set using the priming instructions “To power prime a

cassette:” on page 128.

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Loading an Administration Set Chapter 4: Infuser Preparation

To Check LED and Speaker Function

The infuser provides the following features used to check the function of the LEDs and speaker that provide status and alarm indication. Refer to “Settings” on page 28 for more details.

To check channel LEDs:

1. Press the on/off button

2. The Channel LEDs will flash green, yellow, then red.

To check the AC LED:

1. Press the on/off button.

2. AC LED lights.

To check the audio speaker:

1. Press the on/off button

2. Select Settings.

3. Select Sound Volume.

4. Push each of the buttons in the Test Alarm area to sound the Low Urgency, Medium Urgency, and High Urgency alarm tones.

5. The audio speaker also sounds when any valid or invalid key is pressed on the touch screen.

Loading an Administration Set

The infuser prevents free flow delivery by automatically closing the flow stop when the cassette carriage is closed. An audible alarm and touchscreen message occurs if the cassette is improperly loaded.

WARNING: When an administration set is loaded, a small amount of fluid is

expelled each time the cassette carriage is opened or closed. If potent medications are being used, disconnect the administration set from the patient to prevent over medicating the patient.

CAUTION: DO NOT push the cassette carriage closed. Use the LOAD/EJECT

button to open and close the cassette carriage.

CAUTION: DO NOT operate or store a SYMBIQ™ Infusion System with the

cassette carriage opened. To avoid damaging the cassette carriage, keep it securely closed while the infuser is not in use.

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Chapter 4: Infuser Preparation Loading an Administration Set

To load a cassette:

1. Prime administration set prior to loading. Ensure infuser is powered on.

2. During power-on self-test, carriage door opens and closes.

3. Locate and press LOAD/EJECT on the front of the infuser. The cassette carriage opens.

LOAD/EJECT BUTTONLOAD/EJECT BUTTON

LOAD/ EJECT

STOP

Figure 50: LOAD/EJECT Button

LOAD

/EJECT

WARNING: ALWAYS prime the administration set to remove air from the

cassette, tubing, and injection sites prior to connecting to the patient. ALWAYS disconnect the administration set from the patient prior to priming or purging.

4. Grasp the tubing above and below the cassette.

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Loading an Administration Set Chapter 4: Infuser Preparation

5. Position the cassette with the white flow stop facing the infuser and the purple collar positioned at the top of the cassette carriage.

Note: Prior to loading a cassette, close the flow stop.

Note: The carriage door closes in approximately ten seconds. Press

LOAD/EJECT button to open

door.

6. Slide the cassette into the cassette carriage. Ensure the cassette is seated at the bottom of the carriage and the tubing is aligned vertically.

Figure 51: Sliding the Cassette into the Cassette Carriage

Note: When loading a cassette, the channel LED is lit flashing green while the cassette

carriage opens and closes.

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Chapter 4: Infuser Preparation Loading an Administration Set

7. Once the cassette is properly seated at the bottom of the carriage, the cassette carriage closes automatically in approximately ten seconds or the user presses

Figure 52: Carriage Closed

LOAD/EJECT.

8. Secure administration set tubing into proximal (upper) tubing guides on handle. Allow a little slack between guide and the cassette to reduce the risk of proximal occlusion alarms.

Figure 53: Tube Retainer Guides

9. Secure tubing into distal (lower) tubing guides. Allow a little slack between cassette and the guide to reduce the risk of distal occlusion alarms.

Note: Open CAIR roller clamp, verify no drops are flowing in drip chamber.

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Loading an Administration Set Chapter 4: Infuser Preparation

Removing a Cassette

CAUTION: DO NOT push the cassette carriage closed. Use the LOAD/EJECT

button to open and close the cassette carriage.

CAUTION: DO NOT operate or store a SYMBIQ™ Infusion System with the

cassette carriage opened. To avoid damaging the cassette carriage, keep it securely closed while the infuser is not in use.

To remove a cassette from the carriage:

1. Prior to powering down, ensure the infuser is in Stop mode. Close the CAIR roller clamp and/or slide clamp prior to removing administration set from infuser. Press open the cassette carriage.

LOAD/EJECT BUTTONLOAD/EJECT BUTTON

STOP

LOAD/ EJECT

LOAD

/EJECT

LOAD/EJECT to

Figure 54: LOAD/EJECT Button

2. Grasp the tubing above and below the cassette. Slide the cassette upward out of the cassette carriage.

Figure 55: Removing Cassette From Infuser

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Chapter 4: Infuser Preparation Loading an Administration Set

3. Close the cassette carriage by pressing the LOAD/EJECT button or the cassette carriage will close automatically in approximately 10 seconds.

Load/Eject

Buttons

LOAD/EJECT

STOP

LOAD

/EJECT

Figure 56: LOAD/EJECT Button

4. Press and hold the On/Off button for one second to power down. Discard the administration set and fluid container per CDC, hospital, or healthcare provider guidelines.

Ejecting a Cassette in an Emergency

In an emergency (for example, a complete power failure) the cassette can be manually ejected from the cassette carriage. This should be done only in an emergency. If a cassette is manually ejected, remove the infuser from service immediately. The Check Cassette alarm activates whenever a cassette is manually ejected. With the Check Cassette alarm active, the user cannot program, start, or resume a therapy.

CAUTION: Manually ejecting a cassette renders that channel incapable of

infusing until it is reset by Biomed.

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Loading an Administration Set Chapter 4: Infuser Preparation

To manually eject a cassette from the carriage:

1. Locate the Cassette Eject Lever on the underside of the infuser.

Figure 57: Cassette Eject Lever

2. Pull the Cassette Eject Lever toward the front of the infuser to open the cassette carriage. The Check Cassette alarm activates.

3. Remove the tubing from the tube retainer guides on the front of the infuser and on the infuser handle.

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Chapter 4: Infuser Preparation Loading an Administration Set

4. Grasp the tubing above and below the cassette.

5. Slide the cassette out of the cassette carriage.

6. Contact Biomed to reset the channel.

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Chapter 5: Program (Basic) Therapy

Programming a Basic Therapy

Entering a Program (Basic):

1. Press the On/Off button to power on and load administration set. The STARTUP SCREEN displays.

SYMBIQ

Infusion System

Software Version

X.XX

Drug Library Version

X.XX

Medical Center

November 1, 2006

08:47 AM

PLEASE WAIT

WHILE PUMP INITIALIZES

2. The New Patient dialog box displays (unless the infuser has been powered off for more than five hours).

New Patient?

100

New Patient?

Clear Shift Totals?

View

SolutionSolution

Solution

Patient Info

3. The New Patient dialog box defaults to Ye s . Press

parameters, settings, shift and program totals in the

100

Yes

1:40

Air Sensitivity:

Yes

Continue

Continue to clear previous program

PATIENT INFORMATION SCREEN.

4. To retain previous program parameters and settings: Press the

SYMBIQ™ Infusion System Operating Manual 77

New Patient field and select No. Press Continue to display the PATIENT INFORMATION SCREEN.

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Chapter 5: Program (Basic) Therapy Programming a Basic Therapy

5. On the PATIENT INFORMATION SCREEN, press the CCA (Clinical Care Area) field and select from the list of available CCAs.

0mL/hr 0mL

CCA Field

Select CCA.

Alarm

Mode

08:47 AM

Settings Logs

LockStandby

Figure 58: Blank Patient Information Screen

Note: Prior to programming a therapy a CCA must be selected.The CCA field is the only

field that must be selected before Done becomes available and programming can proceed.

Note: If no CCAs have been downloaded to the infuser, the default CCA selection will be No

CCA. If one or more CCAs have been downloaded to the infuser, the default CCA selection will be Select CCA.

NICU

ICU

Recovery

Nursery

Cancel

Figure 59: Sample List of Available CCAs

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Programming a Basic Therapy Chapter 5: Program (Basic) Therapy

6. Some CCAs may have restricted access and require a passcode (if enabled by facility)

Enter Code

Enter CCA Access passcode to accept CCA

selection.

Cancel Enter

Enter CCA Access passcode by pressing number buttons and then press Enter. Cancel to exit.

Enter

Figure 60: Enter Code Dialog Box for CCA Access

Note: Entering an invalid passcode activates the Invalid Passcode system message. Entering

an invalid passcode a fourth time closes the Enter Code dialog box and displays the

PATIENT INFORMATION SCREEN without changing the CCA.

7. Patient and/or caregiver information are optional and can be bypassed by pressing

Done.

8. To enter patient and/or caregiver information, press the following fields in any order:

• Caregiver ID

•Patient Info

• Last Name

•First Name

•ID

Other touchscreen alpha/numeric keypad buttons have the following functions:

Cancel displays the PATIENT INFORMATION SCREEN without saving entries

•

• Clear restores default field values

Enter accepts entries and displays the PATIENT INFORMATION SCREEN

•

Last Name

Cancel

Space

123

Clear

Backspace

+&>

Enter

Figure 61: Patient Information Screens for Last Name Entry

Note: To navigate between alpha, numeric, and symbol screens, press 123, ABC or +&>

buttons to reach the respective screens.

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Chapter 5: Program (Basic) Therapy Programming a Basic Therapy

9. On the PATIENT INFORMATION SCREEN, press Clear Information and Data to remove all patient values entered, or press

Done to exit PATIENT INFORMATION SCREEN and begin programming.

• CCA

• current caregiver ID

• shift totals

• program totals

• current program

• visibility of all logs in Clinical mode

0mL/hr 0mL

Clear Patient Information

and Data

Press fields to enter optional information. Done to continue.

Settings Logs

Mode

08:47 AM

ICU

GREEN

SMITH

PAT

976543

LockStandby

0mL/hr 0mL

Done

Alarm

Figure 62: Patient Information Screen

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Programming a Basic Therapy Chapter 5: Program (Basic) Therapy

10. Press Basic from the Channel Level Therapy buttons and Select Infusion field.

0mL/hr 0mL

ICU

0mL/hr 0mL

Bolus

Basic

Infusion

Weight BSA

Basic

Select Infusion

Advanced

Piggyback

Infusion Field

Dose

Rate

VTBI

Time

Clear

Press fields to edit. Clear to delete all entries. Options to edit program settings. Next to continue.

Mode

08:47 AM

Options

Settings Logs

--:--

mL/hr

hh:mm

Cancel

Titration

LockStandby

Next A

Alarm

Figure 63: Basic Programming Screen (Blank)

11. Select the desired medication on the Infusion Selection drop-down list.

Infusion

Weight BSA

Dose

Rate

IV Fluid

Carboplatin

Cyclosporine

VTBI

Time

Cancel

DOBUTamine

Docelaxel

DOPamine

Figure 64: Infusion Selection Drop-Down List

Note: Medications appear in the order determined by your facility.

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Chapter 5: Program (Basic) Therapy Programming a Basic Therapy

12. If the selected medication has multiple concentrations, a drop-down list appears. Select the desired concentration from the drop-down list.

[ 450 mg / 250 mL ]

[ 800 mg / 250 mL ]

[ 1,600 mg / 250 mL ]

Figure 65: Concentration Drop-Down List

Specifying Medication Concentration

To program a medication concentration not available from the drop-down list, complete the following steps:

1. From the Select Infusion drop-down list, press the Infusion field and select Other Drug.

Infusion

Other Drug

[Select Concentration]

2. On the Concentration drop-down list, press to enter concentration.

[__/_mL]

3. On the Concentration dialog box, press the Select drop-down field to display and select a Medication Unit. Select Drug Amount in Container and Total Volume in Container field and enter desired values.

CONCENTRATION

Tot al Volume in Container

Enter

Drug Amount In Container

Cancel

Select

Note: If the selected medication has a maximum medication amount defined in the CCA,

the infuser ensures the medication amount entered does not exceed the defined maximum medication amount.

4. Press Select to select dose calculation delivery from available list. Then enter Dose and VTBI.

5. When finished, press Enter to return to the B P

ROGRAM SCREEN without saving concentration entries, press Cancel.

ASIC PROGRAM SCREEN. To return to the BASIC

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Programming a Basic Therapy Chapter 5: Program (Basic) Therapy

13. Press the Weight BSA field and Enter Weight using the numeric keypad. Press Enter to accept the patient parameters. The English equivalent measurement is automatically displayed.

Weight BSA

Dose

Rate

Weight

Height

BSA

0 lb

0 in

Calculate

VTBI

Time

Cancel Enter

Figure 66: Dose Calculation Screen

Note: The BSA may be directly entered, or enter the patient weight and height then press

calculate to automatically calculate BSA. If the weight field BSA is gray when

programming medications, the patients weight is not needed as part of the calculation.

On a two- channel infuser, if a different weight is entered on the second channel, a pop-up window appears indicating a patient parameter change.

Basic

[400 mg / 250 mL]

ICU

Advanced

New Previous

0mL/hr

0mL

Bolus

A: BASIC

Infusion

Weight BSA

New program values differ from previous

Dose

values.

Rate

Parameter

VTBI

Weight (kg) 75 70

Select Infusion

DOPamine

Weight

Patient Parameter Change

Height

BSA

75 mL / hr

1000 mL

IV Fluid

Piggyback

Time

Cancel Continue

Press Continue to change value(s). Press Cancel to keep previous value(s).

Alarm

Mode

08:47 AM

Settings Logs

LockStandby

Figure 67: Patient Parameter Change Screen

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Chapter 5: Program (Basic) Therapy Programming a Basic Therapy

Press continue to retain the entered value. Press cancel to go to the Basic Screen to change the value.

0mL/hr 0mL

ICU

75 mL / hr

1000 mL

Bolus

Basic

Infusion

Weight BSA

Dose

Rate

(Calculated)

VTBI

Time

(Calculated)

Clear

Press fields to edit. Clear to delete all entries. Options to edit program settings. Next to continue.

Mode

08:47 AM

Basic

Select Infusion

DOPamine

75 kg

OptionsClear

Options

Settings Logs

Advanced

[400 mg / 250 mL]

mcg / kg / min

mL/hr

hh:mm

--:--

Titration

Cancel

Piggyback

Next A

LockStandby

Alarm

Figure 68: Dose Calculation Dialog Box

14. Press the Dose field and enter the dose using the numeric keypad. Then press Enter to accept the dose. The rate is automatically calculated and appears in the rate field.

• Press the

Rate field and enter the rate using the numeric key pad if the medication is

delivered in mL/hr.

Note: Entering the Rate first automatically calculates the Dose.

Note: If dosing units are not predefined, the user must enter the dosing units during the program

sequence.

15. Press VTBI field (Volume to be infused) and enter the amount of fluid to be delivered. Time is automatically calculated. Press

Enter to accept VTBI.

Note: By Entering two of the three programming parameters (Rate, VTBI, or Time)

automatically calculates the third.

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Programming a Basic Therapy Chapter 5: Program (Basic) Therapy

16. To enter Time—if required—press Time field. Select hours (hh) or minutes (mm). Enter time period using numeric keypad. Press

1 2 3

Enter.

4 5 6

7 8 9

Hours Minutes

ClearCancel Enter

Figure 69: Time Touchscreen Numeric Keypad

Note: Entering the time first automatically calculates the VTBI.

17. Press

Next A. Verify that the displayed values on CONFIRM PROGRAM SCREEN match the source

container and physician’s order. Again press Next A.

Basic

13.1

103

07:51

--:--

ICU

Advanced

[400 mg / 250 mL]

mcg / kg / min

mL/hr

hh:mm

Cancel

Titration

0mL/hr

Bolus

Basic

0mL

Select Infusion

DOPamine

70 kg

Infusion

Weight BSA

Dose

Rate

(Calculated)

VTBI

Time

(Calculated)

OptionsClear

Clear

Press fields to edit. Clear to delete all entries. Options to edit program settings. Next to continue.

Options

0mL/hr 0mL

Piggyback

Next A

Next A Button

Alarm

Mode

08:45 PM

Settings Logs

LockStandby

Figure 70: Basic Programming Screen (Filled)

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Chapter 5: Program (Basic) Therapy Programming a Basic Therapy

18. Verify that the displayed values on CONFIRM PROGRAM SCREEN match the source container and physician’s order. Press

Start Basic A to begin the infusion after confirming program.

Bolus

0mL/hr 0mL

Basic

Bolus

ICU

Advanced

0 mL /hr 0mL

Piggyback

A: CONFIRM BASIC (with KVO)

DOPamine

[400 mg/ 250 mL]

Weight: Dose: Rate: VTBI: Time:

70 kg

5 mcg / kg / min

13.1 mL / hr 103 mL

07:51 hh:mm

Start

Basic A

Button

Start Basic

Press Start to begin infusion. Basic button to edit program.

Mode

08:47 AM

Settings Logs

LockStandby

Alarm

Figure 71: Confirm Program Screen

Note: Verify flow from primary container and green channel LED infusing indicator is illuminated.

19. The therapy begins and the DELIVERING PROGRAM SCREEN displays. To stop the infusion, press

Stop Basic A.

Stop Basic A

Button

Basic

ICU

Advanced

13.1 mL / hr

13.1 mL/hr

DOPamine

103 mL

Bolus

A: DELIVERING BASIC

DOPamine

[ 400mg / 250 mL]

Dose: 5 mcg / kg / min

Rate:

Time Remaining: 07:51 hh:mm

VTBI: 103 mL Volume Infused: 0.4 mL

Stop Basic

Press Stop to end Infusion. Basic button to edit program.

Mode

08:47 PM

Settings Logs

Figure 72: Stop Basic A Button

75 mL/hr

1000 mL

Piggyback

LockStandby

IV Fluid

Alarm

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Programming a Basic Therapy Chapter 5: Program (Basic) Therapy

The Display transitions to the FAR VIEWING SCREEN after approximately 20 seconds, or transition to the

FAR VIEWING SCREEN by touching the screen above the Help Text.

ICU

75 mL / hr

1000 mL

IV Fluid

DOPamine

0mL/hr

13.1 mL / hr

0mL

96.1 mL

DOPamine

[400 mg / 250 mL]

Dose

IV Fluid

mcg/kg/min

Rate

13.

mL / hr

VTBI

96.

Press Dose, Rate, or VTBI button (When available) to edit. Press Tab A or Tab B to display Near Viewing Delivery screen.

Settings Logs

Mode

08:47 AM

Figure 73: Far View Screen

20. If FAR VIEWING SCREEN is displayed, touch the screen to return to the NEAR VIEWING SCREEN to access the

Stop Basic A button.

Rate

VTBI

mL / h

1000

Alarm

LockStandby

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Chapter 5: Program (Basic) Therapy End of Infusion

End of Infusion

The SYMBIQ™ Infusion System activates an alarm at the end of an infusion.

When KVO has been selected, the End Of Infusion (KVO) alarm activates (see Figure 74a). When the VTBI completes, the infusion continues at the selected KVO rate.

The End of Infusion alarm (see Figure 74b below) activates when the VTBI completes and the infuser stops.

ICU

Basic Piggyback

Advanced

00:00 hh:mm

0mL/ hr

0mL

850 mL

75 mL / hr

0 mL

Press here to clear alarm.

Alarm

LockStandby

00:00:05

IV Fluid

Basic

ICU

Advanced

00:00 hh:mm

DOPamine

13.1 mL / hr 0mL

Bolus

A: COMPLETED BASIC

DOPamine

[ 400 mg / 250 mL ]

KVO:

Time Remaining:

VTBI:

Volume Infused:

Stop Basic

Press Stop to stop KVO delivery.

END OF INFUSION (KVO)

Infusion Complete. KVO in progress. Clear or edit current program.

09:26 PM

Mode

Settings Logs

1mL/ hr

0mL

103 mL

75 mL / hr

1000 mL

Piggyback

Press here to clear alarm.

00:00:05

LockStandby

Alarm

IV Fluid

13.1 mL / hr

24.6 mL

DOPamine

Bolus

B: COMPLETED BASIC

IV Fluid

Rate:

Time Remaining:

VTBI:

Volume Infused:

Start Basic

Press Basic button reset or clear program.

END OF INFUSION

Infusion Complete. No KVO. Clear or edit current program.

Mode

09:26 PM

Bolus

Settings Logs

Figure 74: (a) End of Infusion (KVO) and (b) End Of Infusion Alarm Tabs

When the VTBI completes, press the Stop Basic A button to enter a new VTBI. See “Chapter 9:

Program Options” on page 127 on how to select the End of Infusion option.

Note: Prior to VTBI reaching zero, the user may enter additional VTBI without stopping

infusion. If the VTBI reaches zero and KVO starts, the infusion must be stopped and reprogrammed.

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End of Infusion Chapter 5: Program (Basic) Therapy

Titrating an Infusion

The dose, rate, time, and VTBI can be titrated for the selected therapy. Titrating a therapy requires confirmation; if changes are not confirmed or cancelled, a Callback alarm activates. Bolus, Basic, and Piggyback therapies may be titrated during delivery. Multistep therapy may only be titrated while the infusion is stopped. Intermittent may not be titrated.

To titrate a Basic infusion:

1. From the FAR VIEW SCREEN, press the Dose Button.

Note: Rate and VTBI are titrated using the same process.

ICU

75 mL / hr

1000 mL

IV Fluid

DOPamine

0mL/hr

13.1 mL / hr

0mL

96.1 mL

DOPamine

[400 mg / 250 mL]

Dose

IV Fluid

mcg/kg/min

Rate

13.

mL / hr

VTBI

96.

Press Dose, Rate, or VTBI button (When available) to edit. Press Tab A or Tab B to display Near Viewing Delivery screen.

Settings Logs

Mode

08:47 AM

Figure 75: Far View Screen

Rate

VTBI

mL / h

1000

Alarm

LockStandby

SYMBIQ™ Infusion System Operating Manual 89

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Chapter 5: Program (Basic) Therapy End of Infusion

2. The Dose field opens, and the new value is entered using the numeric keypad. Press Enter to accept the new value.

ICU

Advanced

Select Infusion

DOPamine

[400 mg / 250 mL]

DOPamine

Bolus

Infusion

13.1 mL / hr 103 mL

Basic

DOPamine

A: Basic

Weight BSA

Dose

Rate

VTBI

Time

70 kg

07:10

13.1

Select Units

ClearCancel Enter

Use keypad to enter a value between 0.1 and 9,999. Clear to delete entry. Cancel to exit without saving change. Enter to save change and continue.

Settings Logs

Mode

06:36 AM

75 mL /hr

1000 mL

Piggyback

listing)

1 2 3

4 5 6

7 8 9

LockStandby

IV Fluid

Alarm

Figure 76: Titrating Dose

3. Press Next A in the PROGRAM SCREEN to display the CONFIRMATION SCREEN.

Basic

13.1

103

07:51

--:--

ICU

Advanced

[400 mg / 250 mL]

mcg / kg / min

mL/hr

hh:mm

Cancel

Titration

0mL/hr

Bolus

Basic

0mL

Select Infusion

DOPamine

70 kg

Infusion

Weight BSA

Dose

Rate

(Calculated)

VTBI

Time

(Calculated)

OptionsClear

Clear

Press fields to edit. Clear to delete all entries. Options to edit program settings. Next to continue.

Mode

08:45 PM

Options

Settings Logs

Figure 77: Delivery Screen

0mL/hr 0mL

Piggyback

Next A

LockStandby

Next A Button

Alarm

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End of Infusion Chapter 5: Program (Basic) Therapy

4. Verify that the displayed values are appropriate, and press Start Titration A to begin infusion.

ICU

Advanced

DOPamine

Bolus

13.1 mL / hr 103 mL

Basic

Bolus

A: CONFIRM BASIC (with KVO)

DOPamine

[400 mg/ 250 mL]

Weight: Dose: Rate: VTBI: Time:

70 kg

6 mcg / kg / min

13.1 mL / hr 103 mL

06:32 hh:mm

0mL/hr 0mL

Piggyback

Start

Titration

Press Start to begin infusion. Basic button to edit program.

Settings Logs

Mode

08:50 AM

Alarm

LockStandby

Start Titration A

Figure 78: Confirm Basic Screen

Note: The Infuser continues to infuse at the previous rate until Start Titration A is pressed.

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Chapter 5: Program (Basic) Therapy End of Infusion

NOTES:

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Chapter 6: Piggyback

Overview

The piggyback function on the SYMBIQ™ Infuser allows it to deliver fluid from a secondary container at a rate and volume independent of the Basic infusion. When the Piggyback VTBI (volume to be infused) is complete, the Basic infusion automatically resumes at the primary Basic rate. The infusion Complete Callback option can be selected to notify when the piggyback infusion completes.

Piggyback deliveries are only allowed with a Basic program. A Piggyback infusion cannot be programmed with an Advance therapy, or Bolus infusion.

Program a Basic infusion prior to programming a Piggyback infusion.

WARNING: When delivering a Piggyback infusion, use only a SYMBIQ™

primary administration set with a backcheck valve.

When using the piggyback feature verify:

• The medication in the secondary container is compatible with the medication in the primary container.

• The secondary administration set is connected to the upper Y-site using aseptic technique on the primary administration set.

• The interruption of the primary infusion is clinically appropriate for the duration of the piggyback infusion.

To program a piggyback delivery, the user must first program and confirm a Basic therapy for the channel the user intends to use for the piggyback delivery.

Setting the Basic rate greater than the secondary rate results in a more rapid delivery of any residual secondary medication remaining in the line and the cassette.

WARNING: When using the infuser for secondary deliveries (piggybacking),

ensure the fluids being infused are both chemically and physically compatible.

WARNING: For piggyback deliveries from a secondary container, ensure the

secondary container is hung higher than the primary container.

Piggyback with the SYMBIQ™ Infuser requires a SYMBIQ™ Pump Set with a proximal Y-site backcheck valve and a secondary piggyback set with an extension hook. See “Appendix C:

Accessories, Administration Sets, and Components” on page 211 for list numbers. The

secondary container must be placed higher than the primary container. Refer to the instructions included with the piggyback pump set for more information.

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Chapter 6: Piggyback Overview

Preparing for Secondary Delivery (Piggyback)

1. Ensure a primary piggyback pump set with a proximal Y-site backcheck valve is in use. Lower the primary container using the hanger provided with the piggyback set. Ensure the hanger is fully extended, as shown in Figure 79 below.

Figure 79: Primary Piggyback Pump

2. Suspend the secondary container higher than the primary. Prime the secondary set according to the instructions included with the set.

Note: When using a secondary container, ensure the bottom of the secondary container is at

least 9 inches above the fluid level in the primary container. Use additional extension hooks if necessary.

3. Attach the piggyback administration set to upper Y-site using aseptic technique.

Figure 80: Attaching Piggyback to Y-Site

Note: If using a rotating luer device, first push and twist luer slip into CLAVE until tight, then

lock down the rotating collar. This ensures a secure connection and optimal flow rates.

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Overview Chapter 6: Piggyback

4. Suspend the secondary container from the I.V. pole.

CAUTION: Before using a CLAVE® connector, ensure the administration set and

fluid compatibility. Do not use needles to access the CLAVE

connector.

To program a piggyback delivery:

Only medications designated by the facility may be delivered by Piggyback. If a facility determines a medication should not be interrupted, the

Piggyback button may be disabled in the drug

library.

Note: The Piggyback button is unavailable until a primary infusion is programmed on the selected

channel.

1. Press Piggyback on the NEAR VIEWING SCREEN.

Maintenance IV

75 mL/hr

1,000 mL

Bolus

A: DELIVERING BASIC

Basic

ICU

Advanced

15 mL/hr

100 mL

DOPamine

Piggyback

Rate: Time Remaining:

VTBI: Volume Infused:

Stop Basic

Press Stop to end Infusion. Basic button to edit program.

Mode

12:24 PM

Settings Logs

75 mL / hr

13:20 hh:mm

1,000 mL

0mL

LockStandby

Alarm

Figure 81: Delivering Program Screen

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Chapter 6: Piggyback Overview

2. Press the Infusion field and select the desired medication from the drop-down list. Use the scroll bar to locate desired medication.

75 mL / hr

1,000 mL

Maintenance IV

Bolus

A: PIGGYBACK

Infusion

Weight BSA

ICU

Basic

Select Infusion

Advanced

15 mL /hr

100 mL

Piggyback

DOPamine

Infusion

Drop-Down List

Dose

Rate

VTBI

Time

Clear

Press fields to edit. Clear to delete all entries. Options to edit program settings. Next to continue.

Mode

12:25 PM

Options

Settings Logs

--:--

mL/hr

hh:mm

Cancel

Titration

LockStandby

Next A

Alarm

Figure 82: Piggyback Program Screen

Note: If dosing units are not predefined, the user must enter the dosing units during the program

sequence.

See “Programming a Basic Therapy” on page 77 for additional information.

3. Select Rate field and enter desired rate using numeric keypad. Press Enter to accept.

75 mL / hr

1,000 mL

Maintenance IV

Bolus

A: PIGGYBACK

Infusion

Weight BSA

Basic

Select Infusion

Ampicillin

ICU

Advanced

[ 1 grams / 100 mL ]

Dose

Rate

(Calculated)

VTBI

Time

(Calculated)

Clear

Press fields to edit. Clear to delete all entries. Options to edit program settings. Next to continue.

Mode

12:25 PM

100

01:00

--:--

Options

Settings Logs

mL/hr

hh:mm

Titration

Figure 83: Completed Piggyback Program Screen

Cancel

15 mL /hr

100 mL

Piggyback

Next AOptionsClear

Next A

LockStandby

DOPamine

Alarm

Rate

VTBI

96 SYMBIQ™ Infusion System Operating Manual

Hospira Symbiq 16026 User manual [gb]

Specifications and Main Features

Frequently Asked Questions

User Manual

Chapter 1: Introduction

Intended Audience

Document Conventions

Type Conventions

Warnings and Cautions

Warnings

General Cautions

Epidural Administration

Administration Sets and Delivery Cautions

Battery Operation Cautions

Unintended Bolus Delivery

Cleaning Cautions

US FCC (Federal Communications Commission) Statement

FCC Interference Statement

Wireless Device Caution

Radio Frequency Exposure Statement

Electrical Artifacts in Clinical Settings

Chapter 2: Infuser Overview

Infuser Buttons

Touchscreen Buttons

Touchscreen Button Appearance

Touchscreen Icons and Symbols

Rear Infuser AC Power Outlet

Wireless Communication

Infuser Features

Channel Level Features

Channel Feature Availability

Program Level Features Options

Device Level Features

Settings

Logs

Standby:

Program Lock

Chapter 3: Infuser Operations

Infuser Operations Overview

Power Modes

AC Power

Channel LEDs

Battery Power

A/C Power LED

Touchscreen Visibility

Power Off

Programming Mode

Basic Mode

Delivery Mode

Stop Mode

General Programming Guidelines

Calculated Values

Invalid Value Handling

Value Rounding

Biomed Mode

Chapter 4: Infuser Preparation

Overview

Attaching and Removing an Infuser from an I.V. Pole

Infuser Configurations on an I.V. Pole

Attaching Two Infusers

Detaching Connected Infusers

Administration Sets

Preparing Administration Sets

Fluid Container Compatibility

To Check LED and Speaker Function

Loading an Administration Set

Removing a Cassette

Ejecting a Cassette in an Emergency

Chapter 5: Program (Basic) Therapy

Programming a Basic Therapy

Specifying Medication Concentration

End of Infusion

Titrating an Infusion

Chapter 6: Piggyback

Overview