Agilia VP MC Instructions for Use sw ver 2.2 Nov 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 solid foreign objects (> 12.5 mm) and driping liquids

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.

11106-0_master_ifu_agilia_vp_mc_eng

Table of Contents 1

INTRODUCTION

10

1.1

SCOPE ...10

1.2

INTENDED USE ...10

1.3

INTENDED PRODUCTS TO BE INFUSED ...11

1.4

INTENDED USERS ...12

1.5

INTENDED PATIENTS ...13

1.6

CONTRAINDICATIONS ...14

1.7

USE ENVIRONMENT ...15

1.8

SPECIFICITIES FOR HOMECARE ENVIRONMENTS ...15

2

AGILIA CONNECT INFUSION SYSTEM

17

3

DESCRIPTION

18

3.1

FRONT VIEW ...18

3.2

BOTTOM VIEW (DEVICE IDENTIFICATION LABEL) ...18

3.3

BACK VIEW ...19

3.4

KEYPAD ...20

3.5

DISPLAY AND SYMBOLS ...22 3.5.1 3.5.2 3.5.3 3.5.4 3.5.5 3.5.6

3.6 4

Infusion Status... 22 Screen Options... 22 Navigation Buttons ... 23 Alarms and Safety Features... 23 Infusion Features... 23 Data Communication... 24

PACKAGING ...24

FUNDAMENTALS

25

4.1

PROFILES ...25

4.2

DRUG LIBRARIES...26

4.3

DRUG LISTS...27

4.4

DRUGS ...27 4.4.1 4.4.2 4.4.3

Infusion Rates ... 27 Drug X (mL/h)... 27 Hard Limits and Soft Limits ... 27

3

4.4.4

4.5 5

INSTALLATION

7

TYPES OF INSTALLATIONS ...30

5.2

USING THE ROTATING POLE CLAMP...31

5.3

ATTACHING THE PUMP(S) ...33 Attaching to a Pole ... 33 Attaching to a Rail ... 33 Using on a Flat Table ... 34 Attaching Two Pumps Together ... 34

GETTING STARTED

35

6.1

FLOWCHART ...35

6.2

USING THE PUMP FOR THE FIRST TIME ...36

6.3

POWERING ON ...36

6.4

INSTALLING THE ADMINISTRATION SET IN THE PUMP...39

6.5

CONNECTING A DROP SENSOR ...40

6.6

PUMP HEIGHT ...41

OPERATION

42

7.1

FLOWCHART ...42

7.2

SELECTING A PROFILE ...43

7.3

SELECTING THE INFUSION RATE (FLOW RATE OR DOSE) ...44

7.4

SELECTING A DRUG ...45

7.5

PROGRAMMING AN INFUSION ...45 7.5.1 7.5.2 7.5.3

7.6

Programming an Infusion by Flow Rate ... 46 Programming an Infusion by Dose ... 47 Programming Beyond Soft Limits... 54

STARTING AN INFUSION ...56

7.7

MONITORING AN INFUSION ...57

7.8

FUNCTIONS DURING INFUSION ...59 7.8.1 7.8.2 7.8.3 7.8.4

7.9 4

30

5.1

5.3.1 5.3.2 5.3.3 5.3.4

6

Infusion Modes ... 28

DATA SET ...29

Stop ... 59 Rate Titration... 59 Secondary (Piggyback) Infusions... 60 Administering a Bolus... 66

COMPLETING AN INFUSION ...69

7.9.1 7.9.2 7.9.3

7.10

Near End of Infusion Alert ... 69 End of Infusion ... 70 Powering off ... 71

INFUSION MODES ...72 7.10.1 Volume / Time / Rate (V/T/R) ... 72 7.10.2 Volume / Rate (V/R) ... 72 7.10.3 Volume / Time (V/T) ... 72 7.10.4 Time / Rate (T/R)... 72 7.10.5 Simple Rate (only with Drop Sensor) ... 73 7.10.6 Ramp-up / Ramp-down ... 73 7.10.7 Sequential Infusion... 75 7.10.8 Drops/min ... 77

7.11

OTHER FUNCTIONS ...78 7.11.1 Priming the Administration Set ... 78 7.11.2 Advancing an Air Bubble ... 79 7.11.3 Auto-restart... 81 7.11.4 Pre-programming the Pump ... 82

8

MENUS

83

8.1

OVERVIEW ...83

8.2

PROFILE ...85

8.3

PRESSURE ...86

8.4

VOLUME TO BE INFUSED (VTBI) ...88

8.5

KEYPAD LOCK STATUS ...89

8.6

BATTERY LIFE ...91

8.7

VOLUME INFUSED / DOSE INFUSED ...92

8.8

PAUSE ...93

8.9

DRUG ...94

8.10

PATIENT ...95

8.11

DAY/NIGHT MODE ...96

8.12

PRIMARY / SECONDARY ...98

8.13

PROGRAMMED BOLUS ...98

8.14

FLOW RATE (ML/H) / DOSE ...99

8.15

RAMP-UP / RAMP-DOWN ...100

8.16

SEQUENTIAL INFUSION ...100

8.17

ALARM VOLUME ...101

8.18

CALL-BACK ALERT ...102

8.19

VIEW FLOW RATE HISTORY ...104 5

9

8.20

VIEW PRESSURE HISTORY ...105

8.21

VIEW EVENT LOG...106

8.22

DATE / TIME ...107

8.23

MAINTENANCE ...108

8.24

LIBRARY INFORMATION ...109

8.25

CLINICAL INFORMATION ...110

8.26

DATA SET ...111

OPTIONS

112

9.1

COMMANDS ...112

9.2

OPTION DESCRIPTIONS ...112

9.3

PUMP SETTINGS ...113

10 DATA COMMUNICATION

114

10.1

OVERVIEW ...114

10.2

COMMUNICATION VIA AGILIA CABLES ...114

10.3

COMMUNICATION VIA WI-FI ...115

10.4

DATA SET UPLOAD ...116

11 USER TEST

117

12 ALARMS AND SAFETY FEATURES

118

12.1

INTRODUCTION ...118

12.2

ALARM DESCRIPTIONS ...118

12.3

GENERAL REMARKS ...119

12.4

LIST OF ALARMS ...119

12.5

AUDIO ONLY INFORMATION SIGNALS ...125

13 VOLUMAT LINES

6

127

13.1

PREPARING THE ADMINISTRATION SET AND THE FLUID CONTAINER...127

13.2

PRIMING THE ADMINISTRATION SET BEFORE USE ...129

13.3

OTHER USES OF ADMINISTRATION SETS ...131

13.4

REMOVAL AND REPLACEMENT OF ADMINISTRATION SETS ...134

14 DEVICE STORAGE 14.1

135

PRECAUTIONS FOR STORAGE ...135

14.2

STORAGE AND TRANSPORT CONDITIONS...135

14.3

PREPARING THE DEVICE FOR STORAGE ...136

14.4

USING THE DEVICE AFTER STORAGE ...136

15 SPECIFICATIONS

137

15.1

ESSENTIAL FEATURES ...137

15.2

FLOW RATE ...138

15.3

VOLUME TO BE INFUSED (VTBI) ...138

15.4

DOSE TO BE INFUSED (DTBI) ...139

15.5

INFUSION TIME ...139

15.6

CONCENTRATION ...139

15.7

PATIENT DATA ...140

15.8

AIR DETECTION...140

15.9

PRESSURE MANAGEMENT ...141

15.10 ACCURACY ...142 15.11 CALCULATION RULES ...144 15.12 UNITS AND CONVERSION RULES ...145 16 CLEANING AND DISINFECTING

147

16.1

WHEN TO CLEAN AND DISINFECT THE PUMP ...147

16.2

RECOMMENDED AND PROHIBITED AGENTS ...148

16.3

INSTRUCTIONS FOR CLEANING AND DISINFECTING ...148

17 POWER MANAGEMENT

151

17.1

AC POWER SUPPLY PRECAUTIONS...151

17.2

BATTERY PRECAUTIONS ...151

17.3

BATTERY OPERATING MODE ...152

18 TECHNICAL CHARACTERISTICS

153

18.1

POWER SUPPLY ...153

18.2

BATTERY ...153

18.3

POWER CONSUMPTION...153 7

18.4

COMMUNICATION PORT ...154

18.5

INFRARED COMMUNICATION...154

18.6

DROP SENSOR CONNECTOR ...154

18.7

SOUND LEVELS ...155

18.8

COMPLIANCE ...155

18.9

DIMENSIONS AND WEIGHT ...156

18.10 TRUMPET AND START-UP CURVES ...156 19 WI-FI

159

19.1

GENERAL INFORMATION ...159

19.2

SPECIFICATIONS ...160

20 TROUBLESHOOTING

162

21 RECYCLING

164

22 WARRANTY

165

22.1

GENERAL WARRANTY CONDITIONS ...165

22.2

LIMITED WARRANTY ...165

22.3

WARRANTY CONDITIONS FOR ACCESSORIES ...165

23 GUIDANCE AND MANUFACTURER'S DECLARATION ON EMC 23.1

ELECTROMAGNETIC COMPATIBILITY ...166

23.2

ELECTROSTATIC DISCHARGE (ESD) ...167

24 SERVICING

8

166

175

24.1

INFORMATION ON DEVICE SERVICING ...175

24.2

MAINTENANCE REQUIREMENTS ...175

24.3

QUALITY CONTROL ...176

25 GLOSSARY OF TERMS

177

APPENDIX: FACTORY CONFIGURATION

181

INDEX

182

9

1

Introduction

1.1

Scope

These Instructions for Use (IFU) are applicable to the Agilia VP MC and Agilia VP MC WiFi large volume pumps. These devices are referred to throughout this manual as the "Agilia VP MC". 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 186.

1.2

Intended Use

Agilia VP MC is a programmable electronic medical system dedicated to administering a pre-determined volume of infusion product at a programmed rate. This peristaltic pump ensures fluid delivery using pumping and clamping fingers to advance the liquid to the patient through an administration set. Agilia VP MC is a transportable and reusable device that can be used everyday. Agilia VP MC can be used standalone or mounted on the Link Agilia rack. Agilia VP MC can be used for intermittent or continuous infusions. Agilia VP MC is intended for use on only one patient at a time. It can be reused indefinitely on multiple patients throughout its lifetime.

10

1.3

Intended Products to be Infused

Warning In homecare environment, the pump must only be used to infuse noncritical drugs. Otherwise, there is a risk of interruptions in the therapy which could have critical consequences for the patient. The following fluids can only be infused under the permanent supervision of a trained healthcare professional:  Catecholamines

 Morphine  Chemotherapy  Other critical drugs The pump administers products through clinically accepted routes. These products include but are not limited to the following: Intended Product Parenteral Fluids

Medication

Transfusion

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

When using Agilia VP MC to infuse critical medications in healthcare facilities, ensure that adequate monitoring is provided, and that backup pumps and administration sets are available for immediate use. Only use Agilia VP MC for the infusion of fluids that are intended for infusion pumps. Administration Routes The system allows infusion via the following access routes:

 IV access with any device that administers a medical fluid to a vein and is equipped with a female Luer lock

 Subcutaneous access 11

1.4

Intended Users

In healthcare facilities, 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. In homecare environments, the pump must only be used by appropriately trained users including homecare professionals, patients or their relatives (in case of patient's inability to correctly react to pump alarms). In homecare environements, the IFU must be provided to the homecare nurse. Two Quick Reference Guides are available (one for homecare professionals, one for the patient) in order to describe the typical operations performed at home. We recommend using them and keeping the Quick Reference Guide for the patient near the pump. 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.

12

1.5

Intended Patients

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

Male Female

Age

Neonates (except in homecare environment) Pediatrics Adults Elderly

Weight

0.25 kg to 350 kg

Body Surface Area

0.05 m² to 4.5 m²

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

13

1.6

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.) - Ultrasonic environments - 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.

14

1.7

Use Environment

Agilia VP MC is intended for use in the following environments:

 Healthcare facilities, under the supervision of trained healthcare personnel.

 Homecare environment, by following specific precautions: See section 1.8, page 14. 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 (525 mmHg / 10.15 PSI) to 1060 hPa (795 mmHg / 15.37 PSI)

 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

 The pump can be used in ambulances exclusively with the Agilia

Ambulance Holder accessory. Due to use into road ambulances, performances of the device can be modified. For more information, refer to Agilia Holder Ambulance IFU.

 For more information on using the device in specific conditions, contact your Fresenius Kabi representative.

1.8

Specificities for Homecare Environments

Warning Product version Only pumps with software version 2.2 or above can be used in homecare environments. In early versions, all homecare functionalities are unavailable. If your software version is not compatible with homecare environments, contact your Fresenius Kabi representative. 15

Environment Considerations

 Consider the following operational conditions to ensure proper device performance: - Do not expose to sun light, keep in dry place, at room temperature, normal pressure. - Keep in clean environment. - Keep away from objects which can potentially damage the device. - Keep away from any noise disturbance which could prevent patient or relatives from hearing the pump alarms. - Keep away from heat source, dust, fluff, direct and prolonged light exposure. - Keep away from animals, pests or children.

 Do not share an outlet with another electrical device. General Considerations

 Healthcare professionals should not divulge to the patient or relatives the pump's lock system or any information that may allow an access to all programming and operating functions.

 The responsibility of using the pump is shared between the healthcare professional and the patient.

 Homecare providers or healthcare facilities are responsible for disposal of administration sets and bags used at home according to current standards in order to limit the risk of harm and infection. Warning

 It is the healthcare professional’s responsibility to ensure that the patient or his/her relatives have the required capacity (physical, cognitive or perceptive) to use the pump in homecare environments. Otherwise, there is a risk of usage errors and incorrect therapy which could have critical consequences for the patient.

 Homecare providers must ensure that they can provide backup sets and a backup pump within a short time period to avoid interruptions of administration which could have critical consequences in case of pump failure in the patient’s home.

 Give particular attention to the risk of strangulation with cables and sets, and with the small parts that could be swallowed or inhaled.

Maintenance and Calibration Homecare providers are responsible for periodic maintenance and calibration of pumps used in homecare environments. 16

2

Agilia Connect Infusion System

Agilia Range

Description

Agilia VP range

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

Agilia SP range

Syringe Infusion Pump Pumps designed to deliver the contents of a syringe through a 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.

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.

Accessories

Agilia Ambulance Holder

Medical device intended to be used in road ambulances equipped with AC power source and a horizontal rail in order to fix an infusion pump.

Disposables

Volumat Lines

Administration Sets Administration sets can be in contact with the patient (applied part).

Pump

Software

Rack

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

17

3

Description

3.1

Front View

1

3

2 Figure 3.1: Front View Legend 1

Handle

21

Pump Door

3.2

3

Door Lever

Bottom View (Device Identification Label)

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

18

3.3

Back View

7 6 5 1 4

2 3 Figure 3.2: Back View Legend 1

Release Button

53

Power Cord Inlet

21

Drop Sensor Connection Socket

63

Infrared Cell

3

Rotating Pole Clamp

73

Attachment Lock Knob

4

RS232 Communication Port

Symbol

Location

Description

Warning Near Power Cord Inlet

Near RS232 Communication Port

See section 18, page 153.

Warning See section 10, page 114.

19

3.4

Keypad

3.4.1

Keypad Description

1 2

17

3

16

4

15 14

5

6

7

8

9

10 11

12

13

Figure 3.3: Keypad Legend

20

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 / Advance Air

14 3

Cancel Value / Move Back to Previous Field

73

Fast Increment

15 3

Menu

83

Increment

16 3

Pressure Menu

93 7

Infusion Indicator Lights

17 3

Alarm Silence