Agilia SP MC Instructions for Use sw ver 2.2 Jan 2017

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 dripping 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.

11502-2_ifu_agilia_sp_mc_eng

Table of Contents 1

INTRODUCTION 1.1

9

SCOPE ...9

1.2

INTENDED USE ...9

1.3

PRINCIPLES OF OPERATION ...10

1.4

INTENDED PRODUCTS TO BE INFUSED ...10

1.5

INTENDED USERS ...11

1.6

INTENDED PATIENTS ...11

1.7

CONTRAINDICATIONS ...12

1.8

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... 20

PACKAGING ...21

FUNDAMENTALS

22

4.1

PROFILES ...22

4.2

DRUG LIBRARIES...23

4.3

DRUG LISTS...24

4.4

DRUGS ...24 4.4.1 4.4.2 4.4.3

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

3

4.4.4

4.5 5

INSTALLATION

7

26

5.1

TYPES OF INSTALLATIONS ...26

5.2

USING THE ROTATING POLE CLAMP...27

5.3

ATTACHING THE PUMP(S) ...29 5.3.1 5.3.2 5.3.3 5.3.4

6

Infusion Modes ... 25

DATA SET ...25

Attaching to a Pole ... 29 Attaching to a Rail ... 29 Using on a Flat Table ... 30 Attaching Two Pumps Together ... 30

GETTING STARTED

31

6.1

FLOWCHART ...31

6.2

USING THE PUMP FOR THE FIRST TIME ...32

6.3

POWERING ON ...32

6.4

INSTALLING A SYRINGE...34

6.5

PUMP HEIGHT ...35

OPERATION

36

7.1

FLOWCHART ...36

7.2

SELECTING A PROFILE ...37

7.3

SELECTING THE INFUSION RATE (FLOW RATE OR DOSE) ...38

7.4

SELECTING A SYRINGE ...39

7.5

SELECTING A DRUG ...40

7.6

PROGRAMMING AN INFUSION ...41 7.6.1 7.6.2 7.6.3

7.7

Programming an Infusion by Flow Rate ... 41 Programming an Infusion by Dose ... 41 Programming Beyond Soft Limits... 47

STARTING AN INFUSION ...49

7.8

MONITORING AN INFUSION ...50

7.9

FUNCTIONS DURING INFUSION ...52 7.9.1 7.9.2 7.9.3

7.10

Stop ... 52 Rate Titration... 52 Administering a Bolus... 53

COMPLETING AN INFUSION ...57 7.10.1 Near End of Infusion Alert ... 57

4

7.10.2 End of Infusion ... 58 7.10.3 Powering off ... 58

7.11

INFUSION MODES ...59 7.11.1 Simple Rate... 59 7.11.2 Volume/Time & Dose/Time ... 59 7.11.3 Volume Limit... 60

7.12

OTHER FUNCTIONS ...62 7.12.1 Priming the Syringe and the Extension Set... 62 7.12.2 Pre-programming the Pump ... 64

8

MENUS

65

8.1

OVERVIEW ...65

8.2

PROFILE ...66

8.3

PRESSURE ...67

8.4

KEYPAD LOCK STATUS ...70

8.5

BATTERY LIFE ...72

8.6

VOLUME INFUSED / DOSE INFUSED ...73

8.7

PAUSE ...74

8.8

PROGRAMMED BOLUS ...75

8.9

PATIENT ...75

8.10

DAY/NIGHT MODE

...76

8.11

VOLUME/TIME & DOSE/TIME ...78

8.12

VOLUME LIMIT...78

8.13

ALARM VOLUME ...79

8.14

VOLUME-DOSE HISTORY ...80

8.15

VIEW FLOW RATE HISTORY ...81

8.16

VIEW PRESSURE HISTORY ...82

8.17

SYRINGE...83

8.18

VIEW EVENT LOG...84

8.19

DATE / TIME ...85

8.20

MAINTENANCE ...86

8.21

LIBRARY INFORMATION ...87

8.22

CLINICAL INFORMATION ...88

8.23

DATA SET ...89

5

9

OPTIONS 9.1

90

COMMANDS ...90

9.2

OPTION DESCRIPTIONS ...90

9.3

PUMP SETTINGS ...91

10 DATA COMMUNICATION

92

10.1

OVERVIEW ...92

10.2

COMMUNICATION VIA AGILIA CABLES ...92

10.3

COMMUNICATION VIA WI-FI ...93

10.4

DATA SET UPLOAD ...94

11 USER TEST

95

12 ALARMS AND SAFETY FEATURES

96

12.1

INTRODUCTION ...96

12.2

ALARM DESCRIPTIONS ...96

12.3

GENERAL REMARKS ...97

12.4

LIST OF ALARMS ...97

13 SYRINGES 13.1

SYRINGE LIST ...103

13.2

PREPARING A SYRINGE ...104

13.3

OPERATIONS FOR SYRINGES ...106

13.4

GRAVITY INFUSION IN PARALLEL WITH A PUMP ...107

14 DEVICE STORAGE

108

14.1

PRECAUTIONS FOR STORAGE ...108

14.2

STORAGE AND TRANSPORT CONDITIONS...108

14.3

PREPARING THE DEVICE FOR STORAGE ...109

14.4

USING THE DEVICE AFTER STORAGE ...109

15 SPECIFICATIONS

6

103

110

15.1

ESSENTIAL FEATURES ...110

15.2

FLOW RATE ...111

15.3

VOLUME TO BE INFUSED (VTBI) ...111

15.4

DOSE TO BE INFUSED (DTBI) ...112

15.5

INFUSION TIME ...112

15.6

CONCENTRATION ...112

15.7

PATIENT DATA ...113

15.8

PRESSURE MANAGEMENT ...113

15.9

ACCURACY ...114

15.10 UNITS AND CONVERSION RULES ...116 16 CLEANING AND DISINFECTING

118

16.1

WHEN TO CLEAN AND DISINFECT THE PUMP ...118

16.2

RECOMMENDED AND PROHIBITED AGENTS ...119

16.3

INSTRUCTIONS FOR CLEANING AND DISINFECTING ...119

17 POWER MANAGEMENT

122

17.1

AC POWER SUPPLY PRECAUTIONS...122

17.2

BATTERY PRECAUTIONS ...122

17.3

BATTERY OPERATING MODE ...123

18 TECHNICAL CHARACTERISTICS

124

18.1

POWER SUPPLY ...124

18.2

BATTERY ...124

18.3

POWER CONSUMPTION...124

18.4

COMMUNICATION PORT ...125

18.5

INFRARED COMMUNICATION...125

18.6

SOUND LEVELS ...126

18.7

COMPLIANCE ...126

18.8

DIMENSIONS AND WEIGHT ...127

18.9

TRUMPET AND START-UP CURVES ...127

19 WI-FI

130

19.1

GENERAL INFORMATION ...130

19.2

SPECIFICATIONS ...131

7

20 TROUBLESHOOTING

133

21 RECYCLING

135

22 WARRANTY

136

22.1

GENERAL WARRANTY CONDITIONS ...136

22.2

LIMITED WARRANTY ...136

22.3

WARRANTY CONDITIONS FOR ACCESSORIES ...136

23 GUIDANCE AND MANUFACTURER'S DECLARATION ON EMC

137

23.1

ELECTROMAGNETIC COMPATIBILITY

23.2

ELECTROSTATIC DISCHARGE (ESD) ...138

23.3

ELECTROMAGNETIC COMPATIBILITY AND INTERFERENCE GUIDANCE

23.4

EMC AND ESSENTIAL PERFORMANCES ...140

24 SERVICING 24.1

...137 .138

147

INFORMATION ON DEVICE SERVICING ...147

24.2

MAINTENANCE REQUIREMENTS ...147

24.3

QUALITY CONTROL ...148

25 GLOSSARY OF TERMS

149

APPENDIX: FACTORY CONFIGURATION

153

INDEX

154

8

1

Introduction

1.1

Scope

These Instructions for Use (IFU) are applicable to the Agilia SP MC and Agilia SP MC WiFi pumps. These devices are referred to throughout this manual as the "Agilia SP 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 156.

1.2

Intended Use

The Agilia SP MC Syringe Pump is intended for use on adults, pediatrics, and neonatal patients for the intermittent or continuous delivery of parenteral fluids (such as solutions, colloids, parenteral nutrition), medications (such as diluted drugs, chemotherapy, anesthesia drugs), blood and blood derivatives, and medications through clinically accepted routes of administration. It is intended for use by trained healthcare professionals in clinical healthcare facilities and in pre-hospital medical ground transportation.

9

1.3

Principles of Operation

Agilia SP MC 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). Agilia SP MC 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. Agilia SP MC can be used for intermittent or continuous infusions. Agilia SP MC is intended for use on only one patient at a time. It can be reused indefinitely on multiple patients throughout its lifetime.

1.4

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

10

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.

1.5

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.

1.6

Intended Patients

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

Male Female

Age

Neonates 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

11

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.

1.7

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.

12

1.8

Use Environment

Agilia SP MC 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 (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 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.

13

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.

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.

Accessories

Agilia Holder Ambulance

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

Syringes (applied part)

See section 13, page 103.

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

See section 18, page 124.

Warning Near RS232 Communication Port

16

See section 10, page 92.

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 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

Pressure Menu

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) 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 Profile + 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 96.

3.5.5

Infusion Features

Symbol

Description Loading Dose This symbol is displayed when programming a loading dose.

3.5.6 Symbol

Data Communication Description Data Set Loaded A new data set has been loaded to the pump.

20