Agilia SP TIVA Instructions for Use sw ver 2.2 Oct 2016

Symbol Descriptions

IP22

Warning (Refer to the Instructions for Use)

Name and address of the manufacturer / Date of manufacture

Refer to the Instructions for Use

Name and address of the manufacturing facility

Product reference / part number

Protection against electric shock: class II

Product serial number

Non-ionizing electromagnetic radiation

Input terminal - connector

Fragile, handle with care

Output terminal - connector

This way up

Electrical fuses

Keep away from rain

Alternating Current (AC)

Temperature limitation

Direct Current (DC)

Humidity limitation

Index of protection against ingress of water or particulate matter

Atmospheric pressure limitation

Not for use in residential areas

General symbol for recyclable material

Part included in a recycling process

Eco packaging symbol

Protection against leakage current; defibrillation-proof type CF applied part

Warning of a potential hazard that could result in serious personal injury and/or product damage if the written instructions are not followed.

2

0123

CE mark

Recommendations to be followed.

10770-2_master_ifu_agilia_sp_tiva_eng

Table of Contents 1

INTRODUCTION 1.1

9

SCOPE ...9

1.2

INTENDED USE ...9

1.3

INTENDED USERS ...11

1.4

INTENDED PATIENTS ...11

1.5

CONTRAINDICATIONS ...12

1.6

USE ENVIRONMENT ...13

2

AGILIA CONNECT INFUSION SYSTEM

14

3

DESCRIPTION

15

3.1

FRONT VIEW ...15

3.2

BOTTOM VIEW (DEVICE IDENTIFICATION LABEL) ...15

3.3

BACK VIEW ...16

3.4

KEYPAD ...17

3.5

DISPLAY AND SYMBOLS ...19 3.5.1 3.5.2 3.5.3 3.5.4 3.5.5 3.5.6

3.6 4

Infusion Status... 19 Screen Options... 19 Navigation Buttons ... 20 Alarms and Safety Features... 20 Infusion Features... 20 Data Communication... 21

PACKAGING ...21

FUNDAMENTALS

22

4.1

PROFILES ...22

4.2

DRUG LIBRARIES...23

4.3

DRUGS ...24 4.3.1 4.3.2 4.3.3 4.3.4

Infusion Rates ... 24 Drug X (mL/h)... 24 Hard Limits and Soft Limits ... 24 Infusion Modes ... 25

4.4

DATA SET ...25

4.5

TARGET CONTROLLED INFUSION (TCI)...26 4.5.1

Introduction to Pharmacokinetic Models ... 26

3

4.5.2 4.5.3 4.5.4 4.5.5

5

INSTALLATION

7

5.1

TYPES OF INSTALLATIONS ...31 USING THE ROTATING POLE CLAMP...32

5.3

ATTACHING THE PUMP(S) ...34 Attaching to a Pole ... 34 Attaching to a Rail ... 34 Using on a Flat Table ... 35 Attaching Two Pumps Together ... 35

GETTING STARTED

36

6.1

FLOWCHART ...36

6.2

USING THE PUMP FOR THE FIRST TIME ...37

6.3

POWERING ON ...37

6.4

INSTALLING A SYRINGE...39

6.5

PUMP HEIGHT ...40

OPERATION

41

7.1

FLOWCHART ...41

7.2

SELECTING A PROFILE ...42

7.3

SELECTING THE PROGRAMMING MODE ...42

7.4

SELECTING A SYRINGE ...44

7.5

SELECTING A DRUG ...45

7.6

PROGRAMMING AN INFUSION ...47 7.6.1 7.6.2 7.6.3 7.6.4

Programming an Infusion by Flow Rate ... 47 Programming an Infusion by Dose ... 47 Programming Beyond Soft Limits ... 53 Programming an Infusion (TCI Programming Mode) ... 55

7.7

STARTING AN INFUSION ...58

7.8

MONITORING AN INFUSION ...59

7.9

FUNCTIONS DURING INFUSION ...63 7.9.1 7.9.2

4

31

5.2

5.3.1 5.3.2 5.3.3 5.3.4

6

Target Concentration... 27 Pharmacokinetic Models in the Agilia SP TIVA... 28 TCI Modes in the Agilia SP TIVA ... 29 Populations ... 30

Stop ... 63 Adjusting Infusion parameters: Rate Titration / Target Modification .. 64

7.9.3

7.10

Administering a Bolus... 64

COMPLETING AN INFUSION ...68 7.10.1 Near End of Infusion Alert ... 68 7.10.2 End of Infusion ... 69 7.10.3 Powering off ... 70

7.11

INFUSION MODES ...71 7.11.1 Simple Rate... 71 7.11.2 Volume/Time & Dose/Time ... 71 7.11.3 Volume Limit... 72

7.12

OTHER FUNCTIONS ...74 7.12.1 Priming the Syringe and the Extension Set... 74 7.12.2 Pre-programming the Pump ... 77

8

MENUS

78

8.1

OVERVIEW ...78

8.2

PROFILE ...80

8.3

PRESSURE

8.4

KEYPAD LOCK STATUS ...83

8.5

BATTERY LIFE ...85

8.6

VOLUME INFUSED / DOSE INFUSED ...86

8.7

PAUSE ...87

8.8

PROGRAMMED BOLUS ...88

8.9

PATIENT ...89

...81

8.10

DAY/NIGHT MODE ...90

8.11

VOLUME/TIME & DOSE/TIME ...92

8.12

VOLUME LIMIT...93

8.13

ALARM VOLUME ...94

8.14

VOLUME-DOSE HISTORY ...95

8.15

FLOW RATE HISTORY ...96

8.16

PRESSURE HISTORY ...97

8.17

CONCENTRATION HISTORY ...98

8.18

SYRINGE...99

8.19

VIEW EVENT LOG...100

8.20

DATE / TIME ...101

8.21

MAINTENANCE ...102

8.22

LIBRARY INFORMATION ...103

8.23

CLINICAL INFORMATION ...104 5

9

8.24

DATA SET ...105

8.25

WAKE UP CONCENTRATION ...106

8.26

TCI SETUP ...107

OPTIONS

108

9.1

COMMANDS ...108

9.2

OPTION DESCRIPTIONS ...108

9.3

PUMP SETTINGS ...109

10 DATA COMMUNICATION

110

10.1

OVERVIEW ...110

10.2

COMMUNICATION VIA AGILIA CABLES ...110

10.3

COMMUNICATION VIA WI-FI ...111

10.4

DATA SET UPLOAD ...112

11 USER TEST

113

12 ALARMS AND SAFETY FEATURES

114

12.1

INTRODUCTION ...114

12.2

ALARM DESCRIPTIONS ...114

12.3

GENERAL REMARKS ...115

12.4

LIST OF ALARMS ...115

13 SYRINGES 13.1

SYRINGE LIST ...121

13.2

PREPARING A SYRINGE ...122

13.3

OPERATIONS FOR SYRINGES ...124

13.4

GRAVITY INFUSION IN PARALLEL WITH A PUMP ...125

14 DEVICE STORAGE

6

121

126

14.1

PRECAUTIONS FOR STORAGE ...126

14.2

STORAGE AND TRANSPORT CONDITIONS...126

14.3

PREPARING THE DEVICE FOR STORAGE ...127

14.4

USING THE DEVICE AFTER STORAGE ...127

15 SPECIFICATIONS

128

15.1

ESSENTIAL FEATURES ...128

15.2

FLOW RATE ...129

15.3

VOLUME TO BE INFUSED (VTBI) ...129

15.4

DOSE TO BE INFUSED (DTBI) ...130

15.5

INFUSION TIME ...130

15.6

CONCENTRATION ...130

15.7

PATIENT DATA ...131

15.8

PRESSURE MANAGEMENT ...131

15.9

ACCURACY ...132

15.10 UNITS AND CONVERSION RULES ...134 16 CLEANING AND DISINFECTING

136

16.1

WHEN TO CLEAN AND DISINFECT THE PUMP ...136

16.2

RECOMMENDED AND PROHIBITED AGENTS ...137

16.3

INSTRUCTIONS FOR CLEANING AND DISINFECTING ...137

17 POWER MANAGEMENT

140

17.1

AC POWER SUPPLY PRECAUTIONS...140

17.2

BATTERY PRECAUTIONS ...140

17.3

BATTERY OPERATING MODE ...141

18 TECHNICAL CHARACTERISTICS

142

18.1

POWER SUPPLY ...142

18.2

BATTERY ...142

18.3

POWER CONSUMPTION...142

18.4

COMMUNICATION PORT ...143

18.5

INFRARED COMMUNICATION...143

18.6

SOUND LEVELS ...144

18.7

COMPLIANCE ...144

18.8

DIMENSIONS AND WEIGHT ...145

18.9

TRUMPET AND START-UP CURVES ...145

7

19 WI-FI

148

19.1

GENERAL INFORMATION ...148

19.2

SPECIFICATIONS ...149

20 TROUBLESHOOTING

151

21 RECYCLING

152

22 WARRANTY

153

22.1

GENERAL WARRANTY CONDITIONS ...153

22.2

LIMITED WARRANTY ...153

22.3

WARRANTY CONDITIONS FOR ACCESSORIES ...153

23 GUIDANCE AND MANUFACTURER'S DECLARATION ON EMC

154

23.1

ELECTROMAGNETIC COMPATIBILITY ...154

23.2

ELECTROSTATIC DISCHARGE (ESD) ...155

24 SERVICING 24.1

163

INFORMATION ON DEVICE SERVICING ...163

24.2

MAINTENANCE REQUIREMENTS ...163

24.3

QUALITY CONTROL ...164

25 GLOSSARY OF TERMS

165

APPENDIX 1: FACTORY CONFIGURATION

168

APPENDIX 2: PHARMACOKINETIC MODELS

169

INDEX

171

8

1

Introduction

1.1

Scope

These Instructions for Use (IFU) are applicable to the Agilia SP TIVA and Agilia SP TIVA WiFi pumps. These devices are referred to throughout this manual as the "Agilia SP TIVA". The user must adhere to the instructions specified in this IFU. Failure to adhere to these instructions may result in damage to the equipment, injury to patients or injury to users. Warning Check that this IFU is applicable to the current software version of the device.  The software version of the device is displayed on the start-up screen.

 The software version described in this IFU is displayed in the Release Notes, page 174.

1.2

Intended Use

The Agilia SP TIVA is a programmable electronic medical system dedicated to administering a pre-determined volume of a syringe at a programmed rate. This syringe pump ensures a fluid delivery, by pushing the syringe plunger and advancing the liquid to the patient through an extension set (applied part). The Agilia SP TIVA focuses on anesthesia infusions. The Agilia SP TIVA is a transportable and reusable device that can be used everyday. The size of a syringe can be 5, 10, 20, 30 or 50-60 mL. The Agilia SP TIVA can be used for intermittent or continuous infusions. The Agilia SP TIVA is intended for use on only one patient at a time. It can be reused indefinitely on multiple patients throughout its lifetime.

9

1.2.1

Intended Products to be Infused

The pump administers products through clinically accepted routes. These products include but are not limited to the following: Intended Products Parenteral Fluids

Medication

Transfusion

 Standard solutions  Colloids  Parenteral nutrition  Diluted drugs  Antibiotics  Chemotherapy  Catecholamines  Short acting drugs  Anesthesia drugs  Blood  Red blood cells  Platelets  Plasma  Albumin

When using the Agilia SP TIVA to infuse critical medications, ensure that adequate monitoring is provided, and that backup pumps and syringes are available for immediate use. Only use the Agilia SP TIVA for the infusion of fluids that are intended for infusion pumps.

1.2.2

Administration Routes

The system allows infusion via the following IV access routes:

   

10

IV access with peripheral catheter IV access with central venous catheter IV access with implantable chamber IV access with any other device that administers a medical fluid to a vein and is equipped with a female Luer lock

1.3

Intended Users

The pump must only be used by qualified and trained healthcare professionals including but not limited to: nurses (primary users), physicians, nurse practitioners and physician assistants. Typical initial training duration: 1 hour. It is recommended that users attend a refresher training session of about 20 minutes every year. For training, contact your Fresenius Kabi sales representative.

1.4

Intended Patients

The Agilia SP TIVA is intended to be used according to healthcare facilities protocols on patients with the following characteristics: Patient Characteristics Sex

Male Female

Age

Regular infusion: Neonates, pediatrics, adults, elderly TCI infusion: 1 to 100 years old patients Regular infusion: 0.25 kg to 350 kg TCI infusion: 5 kg to 200 kg

Weight Body Surface Area

0.05 m² to 4.5 m²

Height

20 cm to 250 cm

Note: For more information on patient characteristics with TCI infusion, see section 4.5.5, page 30.

When using the pump with a very sensitive population such as the neonates, make sure to:

 Switch to night mode  Set the alarm volume to the minimum level Warning Specific attention for infusing high risk and life sustaining medication therapies : use the smallest compatible syringe size necessary to deliver the fluid or medication; this is especially important when infusing high risk or life-sustaining medications at low infusion rates (e.g., less than 5 mL per hour, and especially flow rates less than 0.5 mL per hour). Using a larger syringe when infusing at low rates can lead to inadequate syringe pump performance including delivery inaccuracies, delay of therapy, and delayed generation of occlusion alarms. This is due to the increased friction and compliance of the syringe plunger head with larger syringes. 11

1.5

Contraindications

 Do not modify the pump (except in the case of operations recommended by Fresenius Kabi).

 Do not use the pump with the following fluids: - Flammable liquids - Fluids not suitable for infusion

 Do not use the pump in the following environments: - Explosive or flammable environments - High humidity environments (shower, bath, etc.) - Magnetic Resonance Imaging (MRI) - Hyperbaric chamber

 Do not use the pump for the following purposes: - Infusion in association with a dialyser or ECMO - Enteral nutrition - Epidural use

 Do not allow the pump to come in direct contact with the patient's body.

 While the pump is infusing a patient, do not connect a computer installed with Agilia Partner software to perform technical operations.

12

1.6

Use Environment

The Agilia SP TIVA is intended for use in healthcare facilities, under the supervision of trained healthcare personnel. The pump must be used in the following operational conditions to ensure proper performance:

 Operating temperature range: 5 °C to 40 °C

 Operating pressure range: 700 hPa to 1060 hPa

 Operating humidity range: 20 % to 90 % with no condensation

 Altitude: Up to 3000 m above sea-level Warning The functionality of the pump can be affected by pressure variations, mechanical shocks, heat ignition sources, and so on. Information For more information on using the device in specific conditions, contact your Fresenius Kabi representative.

13

2

Agilia Connect Infusion System

Agilia Range

Description

Agilia VP

Volumetric Infusion Pump Pumps designed to deliver the contents of parenteral infusion container (bag or bottle) through an intravenous line connected to a patient.

Agilia SP

Syringe Infusion Pump Pumps designed to deliver the contents of a syringe through an intravenous line connected to a patient.

Agilia Vigilant Drug’Lib

Medication Safety Software Software designed to create, customize and manage data sets to be uploaded to the Agilia VP and SP infusion pumps.

Agilia Partner

Maintenance Software Software designed to maintain, configure, test and calibrate the Agilia VP and SP infusion pumps.

Centerium

Distribution Server Software intended to distribute data sets to Agilia infusion pumps and centralize information coming from infusion pumps for post analysis and reporting.

Vigilant Insight

Infusion Data Reporting Software Software designed to improve the accuracy of clinical settings included into a data set. It provides reports about the use of infusion pumps.

Rack

Link Agilia Link+ Agilia

Stacking Rack Systems Rack systems designed to stack 4, 6 or 8 Agilia infusion pumps. Link Agilia is designed to centralize the power supply. Link+ Agilia is designed to centralize the power supply and to centrally replicate infusion pump signalling.

Disposables

Syringes (applied part)

See section 13, page 121.

Pump

Software

Information For a list of compatible accessories, disposables and software, and for ordering information, refer to the System Components booklet.

14

3

Description

3.1

Front View

1

6

2

4

3

5

Figure 3.1: Front View Legend 1

Handle

41

Plunger Driver

21

Syringe Barrel Clasp

53

Disengagement Lever

3

Syringe Flange Cradle

63

Syringe Guard

3.2

Bottom View (Device Identification Label)

For more information on device identification label symbols, see Symbol Descriptions, page 2. 15

3.3

Back View

6

5 4 3 2

1

Figure 3.2: Back View Legend 1

Release Button

41

Power Cord Inlet

21

Rotating Pole Clamp

53

Infrared Cell

3

RS232 Communication Port

63

Attachment Lock Knob

Symbol

Location

Description

Warning Near Power Cord Inlet

Near RS232 Communication Port

16

See section 18, page 142.

Warning See section 10, page 110.

3.4

Keypad

3.4.1

Keypad Description

1 2

17

3

16

4

15

SP

14

5

6

7

8

9

10 11

12

13

Figure 3.3: Keypad Legend 1

Screen

10 73

Decrement

21

Battery Charge Status Indicator

11 3

Fast Decrement

3

Power Supply Indicator

12 3

Confirm Value / Move to Next Field

4

Wi-Fi Symbol

13 3

Stop

5

On / Off

63

Bolus / Prime

14 3

Cancel Value / Move Back to Previous Field

73

Fast Increment

15 3

Menu

83

Increment

16 3

Graph

93 7

Infusion Indicator Lights

17 3

Alarm Silence

17

3.4.2

Keypad Details

3.4.2.1

Selection Keys

Key

Description Arrow Keys Keys for selecting volume, time, flow rate and other values.

+

Fast Access to Maximum Value or Top of a List

+

Fast Access to Minimum Value or Bottom of a List

Note:

 Pressing and holding any of the arrow keys results in faster increment or decrement.

3.4.2.2

Infusion Indicator Lights

Indicator

Description Infusion in Progress (flashing green) TCI therapy in progress with no flow rate delivery (1 constant green light) Low-Priority Alarm (constant yellow) Medium-Priority Alarm (flashing yellow) High-Priority Alarm (flashing red)

Note:

 Infusion indicator lights provide information about the infusion: in progress, or with a low, medium or high-priority alarm.

 Green indicator lights will continuously flash from right to left while the infusion is running.  The frequency of flashing varies according to flow rate.

3.4.2.3 Indicator

Status Indicators Description Power Supply Indicator When the device is attached to an active power supply, the indicator light is a constant green. If the pump is not connected to the AC power, it does not light up. Battery Charge Status Indicator When the device is attached to an active power supply, the indicator light provides information about battery charge status:  If the indicator is blinking, the battery is being charged.  If the indicator is lit permanently, the battery is fully charged. If the pump is not connected to the AC power, it does not light up.

18

3.5

Display and Symbols

3.5.1

Infusion Status

Symbol

Description Infusion in Progress (Basic & TCI + Custom Profiles with a drug list) Symbols for infusion in progress. Infusion in Progress (Custom Profiles with a drug library) This symbol is displayed when the pump is infusing a drug customized with Agilia Vigilant Drug’Lib software. Infusion Stopped STOP remains in the center of the screen until the user starts the infusion again.

3.5.2 Symbol

Screen Options Description Battery Logo  This symbol shows three different charge levels. < 30 % battery charge 30 % - 70 % battery charge > 70 % battery charge  If the ‘Battery logo’ option is enabled, this symbol is displayed constantly.  If the ‘Battery logo’ option is disabled, this symbol is only displayed when the pump is operating on battery. Pressure Logo This symbol gives information about pump pressure settings and measured pressure levels. Keypad locked symbol This symbol informs the user that the keypad is locked. Wi-Fi module status  The Wi-Fi signal strength is high.  The Wi-Fi signal strength is medium.  The Wi-Fi signal strength is low.  No Wi-Fi signal (the Wi-Fi module is activated).  The Wi-Fi module is not activated.

19

3.5.3

Navigation Buttons

Symbol

Description

start

Start

OK

Confirm

enter

Access Function

New ?

Access Function and Clear Settings

exit

Exit Function

C

Change Selection

prog

Program Function Select / Unselect See More Information

/

Zoom in / Zoom out

/

Move the Event Marker to the Left / Right

3.5.4

Alarms and Safety Features

Symbol

Description Power Disconnection Alarm Silenced Pressure Increase Drop in Pressure

Note: For more information on alarms, see section 12, page 114.

3.5.5

Infusion Features

Symbol

Description Induction Dose This symbol is displayed when programming an induction dose. Plasma Control Mode See section 4.5.4, page 29. Effect-site Control Mode See section 4.5.4, page 29.

20