Instructions for Use
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Agilia VP MC Agilia VP MC WiFi Volumetric Infusion Pumps Applicable to software version 2.2
INSTRUCTIONS FOR USE For use in healthcare facilities and homecare environments
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