Instructions for Use
176 Pages
Preview
Page 1
Agilia SP TIVA Agilia SP TIVA WiFi Syringe Infusion Pumps Applicable to software version 2.2
INSTRUCTIONS FOR USE For use in healthcare facilities
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 ingress of water or particulate matter
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.
10770-2_master_ifu_agilia_sp_tiva_eng
Table of Contents 1
INTRODUCTION 1.1
9
SCOPE ...9
1.2
INTENDED USE ...9
1.3
INTENDED USERS ...11
1.4
INTENDED PATIENTS ...11
1.5
CONTRAINDICATIONS ...12
1.6
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... 21
PACKAGING ...21
FUNDAMENTALS
22
4.1
PROFILES ...22
4.2
DRUG LIBRARIES...23
4.3
DRUGS ...24 4.3.1 4.3.2 4.3.3 4.3.4
Infusion Rates ... 24 Drug X (mL/h)... 24 Hard Limits and Soft Limits ... 24 Infusion Modes ... 25
4.4
DATA SET ...25
4.5
TARGET CONTROLLED INFUSION (TCI)...26 4.5.1
Introduction to Pharmacokinetic Models ... 26
3
4.5.2 4.5.3 4.5.4 4.5.5
5
INSTALLATION
7
5.1
TYPES OF INSTALLATIONS ...31 USING THE ROTATING POLE CLAMP...32
5.3
ATTACHING THE PUMP(S) ...34 Attaching to a Pole ... 34 Attaching to a Rail ... 34 Using on a Flat Table ... 35 Attaching Two Pumps Together ... 35
GETTING STARTED
36
6.1
FLOWCHART ...36
6.2
USING THE PUMP FOR THE FIRST TIME ...37
6.3
POWERING ON ...37
6.4
INSTALLING A SYRINGE...39
6.5
PUMP HEIGHT ...40
OPERATION
41
7.1
FLOWCHART ...41
7.2
SELECTING A PROFILE ...42
7.3
SELECTING THE PROGRAMMING MODE ...42
7.4
SELECTING A SYRINGE ...44
7.5
SELECTING A DRUG ...45
7.6
PROGRAMMING AN INFUSION ...47 7.6.1 7.6.2 7.6.3 7.6.4
Programming an Infusion by Flow Rate ... 47 Programming an Infusion by Dose ... 47 Programming Beyond Soft Limits ... 53 Programming an Infusion (TCI Programming Mode) ... 55
7.7
STARTING AN INFUSION ...58
7.8
MONITORING AN INFUSION ...59
7.9
FUNCTIONS DURING INFUSION ...63 7.9.1 7.9.2
4
31
5.2
5.3.1 5.3.2 5.3.3 5.3.4
6
Target Concentration... 27 Pharmacokinetic Models in the Agilia SP TIVA... 28 TCI Modes in the Agilia SP TIVA ... 29 Populations ... 30
Stop ... 63 Adjusting Infusion parameters: Rate Titration / Target Modification .. 64
7.9.3
7.10
Administering a Bolus... 64
COMPLETING AN INFUSION ...68 7.10.1 Near End of Infusion Alert ... 68 7.10.2 End of Infusion ... 69 7.10.3 Powering off ... 70
7.11
INFUSION MODES ...71 7.11.1 Simple Rate... 71 7.11.2 Volume/Time & Dose/Time ... 71 7.11.3 Volume Limit... 72
7.12
OTHER FUNCTIONS ...74 7.12.1 Priming the Syringe and the Extension Set... 74 7.12.2 Pre-programming the Pump ... 77
8
MENUS
78
8.1
OVERVIEW ...78
8.2
PROFILE ...80
8.3
PRESSURE
8.4
KEYPAD LOCK STATUS ...83
8.5
BATTERY LIFE ...85
8.6
VOLUME INFUSED / DOSE INFUSED ...86
8.7
PAUSE ...87
8.8
PROGRAMMED BOLUS ...88
8.9
PATIENT ...89
...81
8.10
DAY/NIGHT MODE ...90
8.11
VOLUME/TIME & DOSE/TIME ...92
8.12
VOLUME LIMIT...93
8.13
ALARM VOLUME ...94
8.14
VOLUME-DOSE HISTORY ...95
8.15
FLOW RATE HISTORY ...96
8.16
PRESSURE HISTORY ...97
8.17
CONCENTRATION HISTORY ...98
8.18
SYRINGE...99
8.19
VIEW EVENT LOG...100
8.20
DATE / TIME ...101
8.21
MAINTENANCE ...102
8.22
LIBRARY INFORMATION ...103
8.23
CLINICAL INFORMATION ...104 5
9
8.24
DATA SET ...105
8.25
WAKE UP CONCENTRATION ...106
8.26
TCI SETUP ...107
OPTIONS
108
9.1
COMMANDS ...108
9.2
OPTION DESCRIPTIONS ...108
9.3
PUMP SETTINGS ...109
10 DATA COMMUNICATION
110
10.1
OVERVIEW ...110
10.2
COMMUNICATION VIA AGILIA CABLES ...110
10.3
COMMUNICATION VIA WI-FI ...111
10.4
DATA SET UPLOAD ...112
11 USER TEST
113
12 ALARMS AND SAFETY FEATURES
114
12.1
INTRODUCTION ...114
12.2
ALARM DESCRIPTIONS ...114
12.3
GENERAL REMARKS ...115
12.4
LIST OF ALARMS ...115
13 SYRINGES 13.1
SYRINGE LIST ...121
13.2
PREPARING A SYRINGE ...122
13.3
OPERATIONS FOR SYRINGES ...124
13.4
GRAVITY INFUSION IN PARALLEL WITH A PUMP ...125
14 DEVICE STORAGE
6
121
126
14.1
PRECAUTIONS FOR STORAGE ...126
14.2
STORAGE AND TRANSPORT CONDITIONS...126
14.3
PREPARING THE DEVICE FOR STORAGE ...127
14.4
USING THE DEVICE AFTER STORAGE ...127
15 SPECIFICATIONS
128
15.1
ESSENTIAL FEATURES ...128
15.2
FLOW RATE ...129
15.3
VOLUME TO BE INFUSED (VTBI) ...129
15.4
DOSE TO BE INFUSED (DTBI) ...130
15.5
INFUSION TIME ...130
15.6
CONCENTRATION ...130
15.7
PATIENT DATA ...131
15.8
PRESSURE MANAGEMENT ...131
15.9
ACCURACY ...132
15.10 UNITS AND CONVERSION RULES ...134 16 CLEANING AND DISINFECTING
136
16.1
WHEN TO CLEAN AND DISINFECT THE PUMP ...136
16.2
RECOMMENDED AND PROHIBITED AGENTS ...137
16.3
INSTRUCTIONS FOR CLEANING AND DISINFECTING ...137
17 POWER MANAGEMENT
140
17.1
AC POWER SUPPLY PRECAUTIONS...140
17.2
BATTERY PRECAUTIONS ...140
17.3
BATTERY OPERATING MODE ...141
18 TECHNICAL CHARACTERISTICS
142
18.1
POWER SUPPLY ...142
18.2
BATTERY ...142
18.3
POWER CONSUMPTION...142
18.4
COMMUNICATION PORT ...143
18.5
INFRARED COMMUNICATION...143
18.6
SOUND LEVELS ...144
18.7
COMPLIANCE ...144
18.8
DIMENSIONS AND WEIGHT ...145
18.9
TRUMPET AND START-UP CURVES ...145
7
19 WI-FI
148
19.1
GENERAL INFORMATION ...148
19.2
SPECIFICATIONS ...149
20 TROUBLESHOOTING
151
21 RECYCLING
152
22 WARRANTY
153
22.1
GENERAL WARRANTY CONDITIONS ...153
22.2
LIMITED WARRANTY ...153
22.3
WARRANTY CONDITIONS FOR ACCESSORIES ...153
23 GUIDANCE AND MANUFACTURER'S DECLARATION ON EMC
154
23.1
ELECTROMAGNETIC COMPATIBILITY ...154
23.2
ELECTROSTATIC DISCHARGE (ESD) ...155
24 SERVICING 24.1
163
INFORMATION ON DEVICE SERVICING ...163
24.2
MAINTENANCE REQUIREMENTS ...163
24.3
QUALITY CONTROL ...164
25 GLOSSARY OF TERMS
165
APPENDIX 1: FACTORY CONFIGURATION
168
APPENDIX 2: PHARMACOKINETIC MODELS
169
INDEX
171
8
1
Introduction
1.1
Scope
These Instructions for Use (IFU) are applicable to the Agilia SP TIVA and Agilia SP TIVA WiFi pumps. These devices are referred to throughout this manual as the "Agilia SP TIVA". 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 174.
1.2
Intended Use
The Agilia SP TIVA 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). The Agilia SP TIVA focuses on anesthesia infusions. The Agilia SP TIVA 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. The Agilia SP TIVA can be used for intermittent or continuous infusions. The Agilia SP TIVA is intended for use on only one patient at a time. It can be reused indefinitely on multiple patients throughout its lifetime.
9
1.2.1
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 the Agilia SP TIVA to infuse critical medications, ensure that adequate monitoring is provided, and that backup pumps and syringes are available for immediate use. Only use the Agilia SP TIVA for the infusion of fluids that are intended for infusion pumps.
1.2.2
Administration Routes
The system allows infusion via the following IV access routes:
10
IV access with peripheral catheter IV access with central venous catheter IV access with implantable chamber IV access with any other device that administers a medical fluid to a vein and is equipped with a female Luer lock
1.3
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.
1.4
Intended Patients
The Agilia SP TIVA is intended to be used according to healthcare facilities protocols on patients with the following characteristics: Patient Characteristics Sex
Male Female
Age
Regular infusion: Neonates, pediatrics, adults, elderly TCI infusion: 1 to 100 years old patients Regular infusion: 0.25 kg to 350 kg TCI infusion: 5 kg to 200 kg
Weight Body Surface Area
0.05 m² to 4.5 m²
Height
20 cm to 250 cm
Note: For more information on patient characteristics with TCI infusion, see section 4.5.5, page 30.
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 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. 11
1.5
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.) - 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
1.6
Use Environment
The Agilia SP TIVA 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 to 1060 hPa
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 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
Volumetric Infusion Pump Pumps designed to deliver the contents of parenteral infusion container (bag or bottle) through an intravenous line connected to a patient.
Agilia SP
Syringe Infusion Pump Pumps designed to deliver the contents of a syringe through an intravenous 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.
Disposables
Syringes (applied part)
See section 13, page 121.
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
Near RS232 Communication Port
16
See section 18, page 142.
Warning See section 10, page 110.
3.4
Keypad
3.4.1
Keypad Description
1 2
17
3
16
4
15
SP
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
Graph
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) TCI therapy in progress with no flow rate delivery (1 constant green light) 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 & TCI + 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 114.
3.5.5
Infusion Features
Symbol
Description Induction Dose This symbol is displayed when programming an induction dose. Plasma Control Mode See section 4.5.4, page 29. Effect-site Control Mode See section 4.5.4, page 29.
20