Fresenius Kabi AGILIA SP MC WIFI CA User manual

AGILIA SP MC WIFI CA
Syringe Infusion Pump
Applicable to software version 2.2
Instructions For Use
For Use in Healthcare Facilities
(Disponible en Français sur demande)

14209-2_master_ifu_agilia_sp_mc_eng_CA
Symbol Descriptions
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
IN: Input terminal - connector Fragile, handle with care
OUT: Output terminal - connector This way up
Electrical fuses Keep away from rain
Alternating Current (AC) Temperature limitation
Direct Current (DC) Humidity limitation
IP22
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
Caution: Federal law restricts this
device to sale by or on the order of a
physician (See 21 CFR 801.109(b)(1))
CCSAUS mark
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.

3
Table of Contents
1 INTRODUCTION 9
1.1 SCOPE ...................................................................................................9
1.2 INTENDED USE........................................................................................9
1.3 PRINCIPLES OF OPERATION .....................................................................9
1.4 INTENDED PRODUCTS TO BE INFUSED....................................................10
1.5 INTENDED USERS..................................................................................10
1.6 INTENDED PATIENTS .............................................................................11
1.7 CONTRAINDICATIONS.............................................................................12
1.8 USE ENVIRONMENT...............................................................................12
2 DESCRIPTION 13
2.1 FRONT VIEW.........................................................................................13
2.2 BOTTOM VIEW (DEVICE IDENTIFICATION LABEL) .....................................13
2.3 BACK VIEW...........................................................................................14
2.4 KEYPAD................................................................................................15
2.5 DISPLAY AND SYMBOLS .........................................................................17
2.5.1 Infusion Status.................................................................................... 17
2.5.2 Screen Options................................................................................... 17
2.5.3 Navigation Buttons ............................................................................. 17
2.5.4 Alarms and Safety Features............................................................... 18
2.5.5 Infusion Features................................................................................ 18
2.5.6 Data Communication.......................................................................... 18
2.6 PACKAGING ..........................................................................................19
3 FUNDAMENTALS 20
3.1 PROFILES .............................................................................................20
3.2 DRUG LIBRARIES...................................................................................21
3.3 DRUGS .................................................................................................21
3.3.1 Infusion Rates .................................................................................... 21
3.3.2 Drug X (mL/h)..................................................................................... 21
3.3.3 Hard Limits and Soft Limits ................................................................ 22
3.3.4 Infusion Modes ................................................................................... 22
3.4 DATA SET.............................................................................................22

4
4 INSTALLATION 23
4.1 TYPES OF INSTALLATIONS .....................................................................23
4.2 USING THE ROTATING POLE CLAMP.......................................................24
4.3 ATTACHING THE PUMP(S) ......................................................................25
4.3.1 Attaching to a Pole ............................................................................. 25
4.3.2 Attaching to a Rail .............................................................................. 25
4.3.3 Using on a Flat Table ......................................................................... 26
4.3.4 Attaching Two Pumps Together......................................................... 26
5 GETTING STARTED 27
5.1 FLOWCHART .........................................................................................27
5.2 USING THE PUMP FOR THE FIRST TIME ..................................................28
5.3 POWERING ON ......................................................................................28
5.4 INSTALLING ASYRINGE..........................................................................30
5.5 PUMP HEIGHT.......................................................................................31
6 OPERATION 32
6.1 FLOWCHART .........................................................................................32
6.2 SELECTING APROFILE ..........................................................................33
6.3 SELECTING ASYRINGE ..........................................................................33
6.4 SELECTING ADRUG ..............................................................................34
6.5 PROGRAMMING AN INFUSION .................................................................35
6.5.1 Programming an Infusion by Flow Rate ............................................. 35
6.5.2 Programming an Infusion by Dose Rate ............................................ 35
6.5.3 Programming Beyond Soft Limits....................................................... 39
6.6 STARTING AN INFUSION .........................................................................41
6.7 MONITORING AN INFUSION.....................................................................42
6.8 FUNCTIONS DURING INFUSION ...............................................................44
6.8.1 Stop .................................................................................................... 44
6.8.2 Rate Titration...................................................................................... 44
6.8.3 Administering a Bolus......................................................................... 44
6.9 COMPLETING AN INFUSION ....................................................................47
6.9.1 Near End of Infusion Alert ............................................................. 47
6.9.2 End of Infusion ................................................................................... 48
6.9.3 Powering off ....................................................................................... 48
6.10 INFUSION MODES ..................................................................................48
6.10.1 Simple Rate........................................................................................ 48

5
6.10.2 Volume/Time & Dose/Time ................................................................ 49
6.10.3 Volume Limit....................................................................................... 50
6.11 OTHER FUNCTIONS ...............................................................................51
6.11.1 Priming the Syringe and the Extension Set........................................ 51
6.11.2 Pre-programming the Pump ............................................................... 53
7 MENUS 54
7.1 OVERVIEW ............................................................................................54
7.2 PROFILE ...............................................................................................55
7.3 OCCLUSION PRESSURE .........................................................................56
7.4 KEYPAD LOCK STATUS..........................................................................58
7.5 BATTERY LIFE.......................................................................................60
7.6 VOLUME INFUSED / DOSE INFUSED ........................................................61
7.7 PAUSE..................................................................................................61
7.8 PROGRAMMED BOLUS ...........................................................................62
7.9 PATIENT ...............................................................................................63
7.10 DAY/NIGHT MODE .................................................................................63
7.11 VOLUME/TIME & DOSE/TIME..................................................................65
7.12 VOLUME LIMIT.......................................................................................66
7.13 ALARM VOLUME ....................................................................................66
7.14 VOLUME-DOSE HISTORY .......................................................................67
7.15 VIEW FLOW RATE HISTORY ...................................................................68
7.16 VIEW PRESSURE HISTORY ....................................................................69
7.17 SYRINGE...............................................................................................70
7.18 VIEW EVENT LOG..................................................................................70
7.19 DATE /TIME .........................................................................................71
7.20 MAINTENANCE ......................................................................................72
7.21 LIBRARY INFORMATION ..........................................................................73
7.22 CLINICAL INFORMATION .........................................................................74
7.23 DATA SET.............................................................................................75
8OPTIONS 76
8.1 COMMANDS ..........................................................................................76
8.2 OPTION DESCRIPTIONS .........................................................................76
8.3 PUMP SETTINGS ...................................................................................77

6
9 DATA COMMUNICATION 78
9.1 OVERVIEW ............................................................................................78
9.2 COMMUNICATION VIA AGILIA CABLES .....................................................78
9.3 COMMUNICATION VIA WI-FI...................................................................79
9.4 DATA SET UPLOAD ...............................................................................79
10 USER TEST 80
11 ALARMS AND SAFETY FEATURES 81
11.1 INTRODUCTION......................................................................................81
11.2 ALARM DESCRIPTIONS ..........................................................................81
11.3 GENERAL REMARKS ..............................................................................82
11.4 LIST OF ALARMS ...................................................................................82
12 SYRINGES 87
12.1 SYRINGE LIST .......................................................................................87
12.2 PREPARING ASYRINGE .........................................................................87
12.3 OPERATIONS FOR SYRINGES .................................................................89
12.4 GRAVITY INFUSION IN PARALLEL WITH APUMP .......................................90
13 DEVICE STORAGE 91
13.1 PRECAUTIONS FOR STORAGE ................................................................91
13.2 STORAGE AND TRANSPORT CONDITIONS................................................91
13.3 PREPARING THE DEVICE FOR STORAGE .................................................91
13.4 USING THE DEVICE AFTER STORAGE .....................................................91
14 SPECIFICATIONS 92
14.1 ESSENTIAL FEATURES ...........................................................................92
14.2 FLOW RATE ..........................................................................................92
14.3 VOLUME TOBEINFUSED (VTBI) ...........................................................93
14.4 DOSE TOBEINFUSED (DTBI) ...............................................................93
14.5 INFUSION TIME......................................................................................93
14.6 CONCENTRATION ..................................................................................94
14.7 PATIENT DATA ......................................................................................94

7
14.8 PRESSURE MANAGEMENT .....................................................................94
14.9 ACCURACY ...........................................................................................95
14.10 UNITS AND CONVERSION RULES............................................................97
15 CLEANING AND DISINFECTING 99
15.1 WHEN TO CLEAN AND DISINFECT THE PUMP ..........................................99
15.2 RECOMMENDED AND PROHIBITED AGENTS .............................................99
15.3 INSTRUCTIONS FOR CLEANING AND DISINFECTING ................................100
16 POWER MANAGEMENT 103
16.1 AC POWER SUPPLY PRECAUTIONS......................................................103
16.2 BATTERY PRECAUTIONS ......................................................................103
16.3 BATTERY OPERATING MODE ...............................................................104
17 TECHNICAL CHARACTERISTICS 105
17.1 POWER SUPPLY..................................................................................105
17.2 BATTERY ............................................................................................105
17.3 POWER CONSUMPTION........................................................................105
17.4 COMMUNICATION PORT .......................................................................105
17.5 INFRARED COMMUNICATION.................................................................106
17.6 SOUND LEVELS...................................................................................106
17.7 COMPLIANCE ......................................................................................107
17.8 DIMENSIONS AND WEIGHT ...................................................................107
17.9 TRUMPET AND START-UP CURVES .......................................................107
18 WI-FI 110
18.1 GENERAL INFORMATION ......................................................................110
18.2 SPECIFICATIONS .................................................................................110

8
19 TROUBLESHOOTING 112
20 RECYCLING 113
21 WARRANTY 114
21.1 GENERAL WARRANTY CONDITIONS ......................................................114
21.2 LIMITED WARRANTY ............................................................................114
21.3 WARRANTY CONDITIONS FOR ACCESSORIES ........................................114
22 GUIDANCE AND MANUFACTURER'S DECLARATION ON EMC 115
22.1 ELECTROMAGNETIC COMPATIBILITY ....................................................115
22.2 ELECTROSTATIC DISCHARGE (ESD) AND PRECAUTIONS TOBETAKEN .115
22.3 EMC AND ESSENTIAL PERFORMANCE..................................................116
22.4 ELECTROMAGNETIC COMPATIBILITY AND INTERFERENCE GUIDANCE ....116
23 SERVICING 118
23.1 INFORMATION ON DEVICE SERVICING...................................................118
23.2 MAINTENANCE REQUIREMENTS............................................................118
23.3 QUALITY CONTROL .............................................................................118
24 AGILIA CONNECT INFUSION SYSTEM COMPATIBILITY 119
24.1 DATA MANAGEMENT CABLES...............................................................119
24.2 ASSOCIATED SOFTWARE .....................................................................119
24.3 RACKS AND ACCESSORIES ..................................................................120
24.4 SYRINGES...........................................................................................120
25 GLOSSARY OF TERMS 122
APPENDIX: FACTORY CONFIGURATION 124
INDEX 125

9
1Introduction
1.1 Scope
1.2 Intended Use
1.3 Principles of Operation
These Instructions for Use (IFU) are applicable to the Agilia SP MC WiFi. This
device is referred to throughout this manual as the "Agilia SP MC" or "Agilia
pump".
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 127.
The Agilia SP Infusion System is intended for use on adults, pediatrics, and
neonates for the intermittent or continuous delivery of parenteral fluids,
medications, blood and blood derivatives through clinically accepted routes of
administration such as intravenous, intra-arterial and subcutaneous routes.
It is intended for use by trained healthcare professionals in healthcare facilities.
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 fluid delivery, by pushing the syringe plunger and
advancing the liquid to the patient through an extension set equipped with a
female Luer lock (applied part).
Agilia SP MC can be used standalone or mounted on the Agilia Link rack.
Agilia SP MC is a transportable and reusable device that can be used everyday.
The size of a syringe can be minimum of 5 mL and maximum of 60 mL. For
comprehensive list, see Section 24.4, page 120.
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.

10
1.4 Intended Products to be Infused
1.5 Intended Users
The pump administers products through clinically accepted routes. These
products include but are not limited to the following:
Intended Products
Parenteral Fluids
Standard solutions
Colloids
Parenteral nutrition
Medication
Diluted drugs
Antibiotics
Chemotherapy
Catecholamines
Short acting drugs
Anesthesia drugs
Transfusion
Blood
Red blood cells
Platelets
Plasma
Albumin
When using Agilia SP MC to infuse critical medications in healthcare facilities,
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.
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.

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1.6 Intended Patients
Note: 1 kg = 2.2 lb
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 (including elderly)
Weight 0.25 kg to 350 kg
Body Surface Area 0.05 m² to 4.5 m²
When using the pump with specific patients easily affected by light and noise like
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.

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1.7 Contraindications
1.8 Use Environment
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.
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:
41 °F (5 °C) to 104 °F (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 9842.52 ft (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 sales representative.

13
2Description
2.1 Front View
Figure 2.1: Front View
2.2 Bottom View (Device Identification Label)
Legend
Handle Plunger Driver
Syringe Barrel Clasp Disengagement Lever
Syringe Flange Cradle Syringe Guard
The UDI (Unique Device Identifier) is represented in AIDC (Automatic
Identification and Data Capture) and readable 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 Symbol
Descriptions, page 2.
3 5
6
2
1
4
1
1
4
1
2
3
5
3
3
6

14
2.3 Back View
Figure 2.2: Back View
Legend
Release Button Power Cord Inlet
Rotating Pole Clamp Infrared Cell
RS232 Communication Port Attachment Lock Knob
Symbol Location Description
Near Power Cord Inlet
Warning
See section 17, page 105.
Near RS232
Communication Port
Warning
See section 9, page 78.
6
4
3
5
2
1
1
1
4
1
2
3
5
3
3
6

15
2.4 Keypad
2.4.1 Keypad Description
Figure 2.3: Keypad
Legend
Screen Decrement
Battery Charge Status Indicator Fast Decrement
Power Supply Indicator Confirm Value / Move to Next Field
Wi-Fi Symbol Stop
On / Off Cancel Value / Move Back to Previous
Field
Bolus / Prime
Fast Increment Menu
Increment Pressure Menu
Infusion Indicator Lights Alarm Silence
9
15
14
17
16
1312118 10765
1
2
3
4
1
3
710
1
2
3
11
3
3
12
4
3
13
5
3
14
3
6
3
7
3
15
3
8
3
16
3
79
3
17

16
2.4.2 Keypad Details
2.4.2.1 Selection Keys
Note:
Pressing and holding any of the arrow keys results in faster increment or decrement.
2.4.2.2 Infusion Indicator Lights
2.4.2.3 Status Indicators
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
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.
Indicator 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.

17
2.5 Display and Symbols
2.5.1 Infusion Status
2.5.2 Screen Options
2.5.3 Navigation Buttons
Symbol Description
Infusion in Progress (Basic Profile)
Symbols for infusion in progress.
Infusion in Progress (Custom Profiles)
This symbol is displayed when the pump is infusing a drug customized with
infusion limits customized with a compatible DERS.
Infusion Stopped
STOP remains in the center of the screen until the user starts the infusion
again.
Symbol 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.
Symbol Description
Start
Confirm
Access Function
Access Function and Clear Settings
start
OK
enter
New ?

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2.5.4 Alarms and Safety Features
2.5.5 Infusion Features
2.5.6 Data Communication
Exit Function
Change Selection
Program Function
Select / Unselect
See More Information
/Zoom in / Zoom out
/Move the Event Marker to the Left / Right
Symbol Description
Power Disconnection
Alarm Silenced
Pressure Increase
Drop in Pressure
Note: For more information on alarms, see section 11, page 81.
Symbol Description
Loading Dose
This symbol is displayed when programming a loading dose.
Symbol Description
Data Set Loaded
A new data set has been loaded to the pump.
Symbol Description
exit
C
prog

19
2.6 Packaging
The Agilia SP MC packaging contains the following:
1 Agilia SP MC pump
User documents (Language: English)
1 Power cord
Packaging weight: Approximately 1.16 lb (530 g).
Packaging consists of: Recycled cardboard, expanded foam.
Information
It is the healthcare facility’s responsibility to check the pump
integrity upon receipt.
If the packaging contents are incomplete or damaged, contact
your Fresenius Kabi sales representative.

20
3Fundamentals
3.1 Profiles
3.1.1 Basic Profile
3.1.2 Custom Profiles
A profile defines the device configuration and drug library used for a group of
patients in a given healthcare environment.
By default, factory settings include only 1 profile (Basic Profile).
Custom profiles can be created and loaded to the pump using a compatible DERS.
Custom profiles feature a specific pump configuration and a drug library.
A pump can manage up to 20 profiles:
1 Basic Profile
Up to 19 custom profiles
Information
For pumps used on only one group of patients, we recommend disabling
the ability to select the profile, thus locking the pumps to the selected
profile.
Basic Profile allows programming of an infusion for which settings have not been
pre-defined with a compatible DERS.
To program an infusion with Basic Profile, choose "Basic Profile" when selecting
a profile.
Basic Profile has the following characteristics:
The only infusion rate allowed is flow rate (mL/h).
The DERS's safeguards are unavailable:
- The infusion is programmed without drug names.
- Limits on drug infusion rates are not included.
Configurations and settings accessible in Basic Profile may not be suitable for all
patient groups and protocols.
Custom profiles can be created and uploaded to the pump using a compatible
DERS.
A custom profile contains the following:
a specific device configuration (pump settings that control the
mechanical functions of the pump such as alarm volume, and so on)
a drug library (optional), see section 3.2, page 21.
Depending on the way it is pre-configured with the medication safety software, a
custom profile may or may not include all of the functionalities described in this
IFU.