Agilia VP MC Instructions for Use sw ver 4.1

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

Recommendations to be followed.

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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 dripping liquids

Atmospheric pressure limitation

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

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CE mark Unique Device Identifier

2

16491-0_IFU_Agilia_VP_MC_V4.1_Eng

Table of Contents 1

INTRODUCTION

10

1.1 1.2

SCOPE ...10 PRINCIPLES OF OPERATION ...10

1.3

INTENDED PURPOSE ...10

1.4

INTENDED USE ...10 1.4.1 1.4.2 1.4.3 1.4.4 1.4.5 1.4.6

Indications ... 11 Contraindications... 12 Intended Users ... 12 Intended Patients ... 13 Use Environment ... 13 Specificities for Homecare Environments ... 14

1.5 1.6

CLINICAL BENEFITS ...16 SIDE-EFFECTS ...16

1.7

RISKS FOR PATIENTS ...16

2

AGILIA CONNECT INFUSION SYSTEM

17

3

DESCRIPTION

19

3.1 3.2

FRONT VIEW ...19 BOTTOM VIEW (DEVICE IDENTIFICATION LABEL) ...19

3.3 3.4

BACK VIEW ...20 KEYPAD ...21

3.5

DISPLAY AND SYMBOLS ...23

3.6 4

3.5.1 3.5.2 3.5.3 3.5.4 3.5.5

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

PACKAGING ...25

FUNDAMENTALS

26

4.1 4.2

PROFILES ...26 DRUG LIBRARIES...27

4.3

DRUG LISTS...27

4.4

DRUGS ...27 4.4.1 4.4.2

Infusion Rates ... 27 Drug X (mL/h)... 28

3

4.5 5

4.4.3 4.4.4

DATA SET ...29

INSTALLATION

TYPES OF INSTALLATIONS ...30 USING THE ROTATING POLE CLAMP...31

5.3

ATTACHING THE PUMP(S) ...32 Attaching to a Pole ... 32 Attaching to a Rail ... 34 Using on a Flat Table ... 34 Attaching Two Pumps Together ... 35

GETTING STARTED

36

6.1 6.2

FLOWCHART ...36 USING THE PUMP FOR THE FIRST TIME ...37

6.3

POWERING ON ...37

6.4

INSTALLING THE ADMINISTRATION SET IN THE PUMP ...39

6.5

CONNECTING A DROP SENSOR ...40 PUMP HEIGHT ...41

6.6 7

30

5.1 5.2

5.3.1 5.3.2 5.3.3 5.3.4

6

Hard Limits and Soft Limits ... 28 Infusion Modes ... 28

OPERATION

42

7.1 7.2

FLOWCHART ...42 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

7.6 7.7 7.8

7.9

7.5.1 7.5.2 7.5.3

Programming an Infusion by Flow Rate ... 46 Programming an Infusion by Dose ... 47 Programming Beyond Soft Limits ... 53

STARTING AN INFUSION ...54 MONITORING AN INFUSION ...56

FUNCTIONS DURING INFUSION ...58 7.8.1 7.8.2 7.8.3 7.8.4

Stop ... 58 Rate Titration... 58 Secondary (Piggyback) Infusions ... 58 Administering a Bolus ... 64

7.9.1

Near End of Infusion Alert ... 66

COMPLETING AN INFUSION ...66 4

7.10

7.11

7.9.2 7.9.3

End of Infusion ... 67 Powering off ... 68

INFUSION MODES ...68

7.10.1 Volume / Time / Rate (V/T/R) ... 68 7.10.2 Volume / Rate (V/R) ... 68 7.10.3 Volume / Time (V/T) ... 68 7.10.4 Time / Rate (T/R)... 68 7.10.5 Simple Rate (only with Drop Sensor) ... 69 7.10.6 Ramp-up / Ramp-down ... 69 7.10.7 Sequential Infusion... 71 7.10.8 Drops/min ... 73

OTHER FUNCTIONS ...74

7.11.1 Priming the Administration Set ... 74 7.11.2 Advancing an Air Bubble ... 75 7.11.3 Auto-restart... 76 7.11.4 Pre-programming the Pump ... 77

8

MENUS

78

8.1 8.2

OVERVIEW ...78 PROFILE ...80

8.3 8.4

PRESSURE ...81 VOLUME TO BE INFUSED (VTBI) ...83

8.5

KEYPAD LOCK STATUS ...84

8.6

BATTERY LIFE ...86

8.7

VOLUME INFUSED / DOSE INFUSED ...87

8.8

PAUSE ...88

8.9

DRUG ...89

8.10

PATIENT ...90

8.11 8.12

DAY/NIGHT MODE ...91 PRIMARY / SECONDARY ...93

8.13

PROGRAMMED BOLUS ...93

8.14

FLOW RATE (ML/H) / DOSE ...94

8.15 8.16

RAMP-UP / RAMP-DOWN ...95 SEQUENTIAL INFUSION ...95

8.17

ALARM VOLUME ...96

8.18

CALL-BACK ALERT ...97

8.19

VIEW FLOW RATE HISTORY ...99

8.20

VIEW PRESSURE HISTORY ...100 5

9

8.21

VIEW EVENT LOG ...101

8.22

DATE / TIME ...102

8.23

MAINTENANCE ...103

8.24

LIBRARY INFORMATION ...104

8.25

CLINICAL INFORMATION ...105

8.26

DATA SET ...106

OPTIONS

107

9.1 9.2

COMMANDS ...107 OPTION DESCRIPTIONS ...107

9.3

PUMP SETTINGS ...108

10 DATA COMMUNICATION

109

10.1 10.2

OVERVIEW ...109 COMMUNICATION VIA AGILIA CABLES ...109

10.3

COMMUNICATION VIA WI-FI ...110

10.4

DATA SET UPLOAD ...110

11 USER TEST

112

12 ALARMS AND SAFETY FEATURES

113

12.1 12.2

INTRODUCTION ...113 ALARM DESCRIPTIONS ...113

12.3

GENERAL REMARKS ...114

12.4

LIST OF ALARMS ...114

12.5

AUDIO ONLY INFORMATION SIGNALS ...122

13 VOLUMAT LINES

124

13.1 13.2

PREPARING THE ADMINISTRATION SET AND THE FLUID CONTAINER ..124 PRIMING THE ADMINISTRATION SET BEFORE USE ...125

13.3

OTHER USES OF ADMINISTRATION SETS ...127

13.4

REMOVAL AND REPLACEMENT OF ADMINISTRATION SETS ...129

14 DEVICE STORAGE

130

14.1 14.2

PRECAUTIONS FOR STORAGE ...130 STORAGE AND TRANSPORT CONDITIONS...130

14.3

PREPARING THE DEVICE FOR STORAGE ...130 6

14.4

USING THE DEVICE AFTER STORAGE ...131

15 SPECIFICATIONS

132

15.1 15.2

ESSENTIAL FEATURES ...132 FLOW RATE ...132

15.3

VOLUME TO BE INFUSED (VTBI) ...133

15.4

DOSE TO BE INFUSED (DTBI) ...133

15.5

INFUSION TIME ...133

15.6 15.7

CONCENTRATION ...134 PATIENT DATA ...134

15.8

AIR DETECTION...134

15.9

PRESSURE MANAGEMENT ...135

15.10 ACCURACY ...136 15.11 CALCULATION RULES ...137 15.12 UNITS AND CONVERSION RULES ...138 16 CLEANING AND DISINFECTING

141

16.1 16.2

WHEN TO CLEAN AND DISINFECT THE PUMP ...141 RECOMMENDED AND PROHIBITED AGENTS ...142

16.3

INSTRUCTIONS FOR CLEANING AND DISINFECTING ...142

17 POWER MANAGEMENT

145

17.1 17.2

AC POWER SUPPLY PRECAUTIONS...145 BATTERY PRECAUTIONS ...145

17.3

BATTERY OPERATING MODE ...146

18 TECHNICAL CHARACTERISTICS

147

18.1 18.2

POWER SUPPLY ...147 BATTERY ...147

18.3

POWER CONSUMPTION...147

18.4

COMMUNICATION PORT ...148

18.5 18.6

INFRARED COMMUNICATION ...148 DROP SENSOR CONNECTOR ...148

18.7

SOUND LEVELS ...148

18.8

COMPLIANCE ...149

18.9

DIMENSIONS AND WEIGHT ...149 18.10 TRUMPET AND START-UP CURVES ...150 7

19 WI-FI

153

19.1 19.2

GENERAL INFORMATION ...153 SPECIFICATIONS ...154

20 TROUBLESHOOTING

156

21 RECYCLING

158

22 WARRANTY

159

22.1 22.2

GENERAL WARRANTY CONDITIONS ...159 LIMITED WARRANTY ...159

22.3

WARRANTY CONDITIONS FOR ACCESSORIES ...159

23 GUIDANCE AND MANUFACTURER'S DECLARATION ON EMC

160

23.1 23.2

ELECTROMAGNETIC COMPATIBILITY ...160 ELECTROSTATIC DISCHARGE (ESD) ...160

23.3

ELECTROMAGNETIC COMPATIBILITY AND INTERFERENCE GUIDANCE

23.4

EMC AND ESSENTIAL PERFORMANCES ...163

24 SERVICING

.161 169

24.1 24.2

INFORMATION ON DEVICE SERVICING ...169 MAINTENANCE REQUIREMENTS ...169

24.3

QUALITY CONTROL ...170

24.4

NOTIFICATION OF SERIOUS INCIDENT...170

25 CYBERSECURITY

171

25.1 25.2

CYBERSECURITY AND IT-NETWORK ENVIRONMENT ...171 INHERENT DESIGN ...172

25.3

INFORMATION REGARDING CYBERSECURITY ...172

25.4

FIREWALL CONFIGURATION ...174

25.5

POTENTIAL VULNERABILITIES ...174

8

26 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 185.

1.2 Principles of Operation

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 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.

1.3 Intended Purpose Infusion pump and accessories for IV administration of fluids.

1.4 Intended Use

10

1.4.1

Indications 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 is indicated to administer products through clinically accepted routes. These products include: Intended Products Parenteral Fluids

Medication

Blood and blood derivatives

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

Warning Infusion of bolus or small volume of chemotherapy vesicants through peripheraI route should be administered according to the good clinical practice of the healthcare facility. If infusion pump is used, the patient should still be continually assessed for any signs of potential extravasation. When using Agilia VP MC to infuse critical medications in healthcare facilities, ensure 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. Do not use the pump for epidural use. Do not use the pump for enteral nutrition. 11

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. Warning When using Agilia VP MC to infuse critical medications, ensure that adequate monitoring is provided.

1.4.2

Contraindications There are no known contraindications to the use of the device when used according to this document.

1.4.3

Intended Users In healthcare facilities, the pump must only be used by qualified and trained healthcare professionals. 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) under the responsibility of healthcare professionals. In homecare environments, 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

1.4.4

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 1.4.5

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

 Healthcare facilities and in pre-hospital medical ground

transportation, under the supervision of trained healthcare professionals.  Homecare environment under the responsibility of trained healthcare professionals, by following specific precautions: See section 1.4.6, 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 Do not use the pump in the following environments:  Explosive or flammable environments  High humidity environments (shower, bath, etc.)  Ultrasonic environments not to damage the pump or its components  Magnetic Resonance Imaging (MRI) not to deteriorate the MRI images  Hyperbaric chamber 13

Warning The functionality of the pump can be affected by pressure variations, mechanical shocks, heat ignition sources, and so on. Warning Device which may create pressure decrease downstream the pump (i.e. ECMO, dialyser) should be used carefully with the pump and appropriate measures should be taken to avoid influence on the pump performances. Information  The pump can be used in ambulances exclusively with the Agilia Holder Ambulance accessory. Due to use in 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.

1.4.6

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. 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.

14

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.  The use of the Drop Sensor is not recommended for homecare environments. 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 Requirements Homecare providers are responsible for periodic maintenance and calibration of pumps used in homecare environments. Homecare providers must be informed if the device is dropped or if any malfunctions occur. In this case, do not use the device and contact your homecare providers.

15

1.5 Clinical benefits Clinical benefits are achieved through the functions provided to the intended users, which has a positive impact on patient management. Clinical benefits of Agilia VP MC and Agilia VP MC WiFi infusion system are the following:

 Provide a controlled and accurate system for the infusion of large







volume of drugs, fluids and blood products (volume delivery accuracy of the system is ±5%, flow rate adjustable from 0.1 to 1500 mL/h, compatible with a wide range of dedicated administration sets). Provide features and infusion functions adapted to the needs of patients and healthcare professionals (continuous infusion and bolus infusion, dose rate and flow rate modes including ramp mode, sequential mode and secondary infusion mode, pause function, keep vein open function, view infusion history, night mode, infusion monitoring screen, wide range of drugs and fluids compatible). Provide safety features and relevant alarms that improve infusion safety and prevent unexpected infusion discontinuation (Dynamic Pressure System, pressure monitoring, adjustable air parameters, keypad lock options, alarm system compliant with EN/IEC 60601-18). Prevent infusion-related medication errors (with the use of up-todate Dose Error Reduction Software [DERS] configured in line with policy/clinical practice of each healthcare facility).

1.6 Side-effects There is no side-effect directly associated to the use of Agilia VP MC.

1.7 Risks for patients Failure to follow all instructions described in this document or loss or degradation of essential performance (Section 15.1, page 132.) may result in: overdose, underdose, delay of therapy, incorrect therapy, exsanguination, toxicity, infection, air embolism, trauma or electric shock.

16

2

Agilia Connect Infusion System Agilia Range 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 SP PCA

Patient-Controlled Analgesia (PCA) syringe infusion pump Pumps intended for PCA therapy and for the administration of analgesic drugs under the patient’s or the clinician’s control.

Agilia ProNeo

Enteral Nutrition Syringe Pump for Neonates Pumps designed to deliver enteral nutrition to neonates, preterm babies and children via clinically accepted routes of administration.

Vigilant Centerium

Server Software Software intended to report status of compatible Fresenius Kabi infusion devices according to the identified installed base for fleet management, to store and distribute datasets to connected infusion devices and to report distribution status, besides supporting system maintenance operations.

Vigilant Bridge

EMR Auto-documentation Software intended to establish connection between compatible Fresenius Kabi infusion pumps and the Electronic Medical Records (EMR) system. Infusion data is then automatically transmitted to the EMR.

Vigilant Insight

Infusion Data Reporting Software Software intended to collect and report infusion information received from compatible Fresenius Kabi connected infusion devices to analyze and improve clinical settings included into a dataset.

Pump

Vigilant Software Suite

Description

Drug Library Software Software intended to create, customize, and manage drug Vigilant Master Med library data and device configurations to be uploaded to compatible Fresenius Kabi infusion devices.Vigilant Master Med is part of a Dose Error Reduction System (DERS). Vigilant Sentinel

Infusion visualization system Software designed to provide qualified healthcare personnel with a centrally aggregated view of infusion pumps' status within a hospital or hospital-type setting.

17

Agilia Range Software

Agilia Partner

Maintenance Software Software designed to maintain, configure, test and calibrate compatible Agilia infusion devices and accessories.

Link Agilia Agilia Link Link+ Agilia

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

Agilia MRI Guard

MRI-Shielding System Agilia MRI Guard is intended to accommodate and power up to four Agilia infusion pumps so that these pumps can be operated in a Magnetic Resonance Imaging unit.

Agilia Duo

Two-channel accessory The Agilia Duo is intended to centralize mains power for two attached Agilia pumps.

Agilia Holder Ambulance

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

Drop Sensor

Accessory intended to detect drops in the administration set drip chamber when connected to a compatible volumetric pump.

Volumat Lines

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

Accessories

Disposables

Description

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

18

3

Description

3.1 Front View 1

3

2 Figure 3.1: Front View Legend 1

Handle

21

Pump Door

3

Door Lever

3.2 Bottom View (Device Identification Label)

On the device identification label, the UDI (Unique Device Identifier) is presented in machine-readable form (AIDC - Automatic Identification and Data Capture - technology) and as text: ■ (01) Product Identifier GTIN ■ (21) Product Serial Number ■ (11) Date of Manufacture ■ (240) Product Reference For more information on device identification label symbols, see Symbols used in this document, page 2. 19

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

20

See section 18, page 111.

Warning

See section 10, page 109.