Fresenius Kabi
Agilia SP PCA Instructions for Use sw ver 3.1 May 2018
Instructions for Use
167 Pages
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Agilia SP PCA Agilia SP PCA WiFi Syringe Infusion Pumps Applicable to software version 3.1
Instructions For Use For Use in Healthcare Facilities
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
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
IP22
Ingress protection against solid foreign objects (> 12.5 mm) and dripping liquids. Rating applies to pump.
Atmospheric pressure limitation
IP27
Ingress protection against water when immersed up to 1 m deep. Rating applies to patient handset but not to the handset connector.
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.
CE mark 0123
Recommendations to be followed.
13746-1_ifu_agilia_sp_pca_eng
Table of Contents 1
INTRODUCTION
10
1.1
SCOPE ...10
1.2
INTENDED USE ...10
1.3
PRINCIPLES OF OPERATION ...10
1.4
INTENDED PRODUCTS TO BE INFUSED ...11
1.5
INTENDED USERS ...11
1.6
INTENDED PATIENTS ...12
1.7
CONTRAINDICATIONS ...13
1.8
USE ENVIRONMENT ...13
2
AGILIA CONNECT INFUSION SYSTEM
15
3
DESCRIPTION
16
4
5
3.1
PUMP FRONT VIEW ...16
3.2
PUMP BACK VIEW ...17
3.3
PUMP BOTTOM VIEW (DEVICE IDENTIFICATION LABEL) ...17
3.4
PATIENT HANDSET ...18
3.5
KEYPAD DESCRIPTION ...18
3.6
DISPLAY AND SYMBOLS ...20
3.7
PACKAGING ...22
FUNDAMENTALS
23
4.1
DEFINITIONS OF TERMS USED IN PCA THERAPY ...23
4.2
PCA MODES ...24
4.3
GENERAL INFUSION MODES...27
4.4
DERS INTERFACE ...27
INSTALLATION
31
5.1
TYPES OF INSTALLATIONS ...31
5.2
USING THE ROTATING POLE CLAMP...32
5.3
ATTACHING THE PUMP ...33
5.4
INSTALLING AND REMOVING THE PROTECTIVE COVER ...35
5.5
CONNECTING AND DISCONNECTING THE PATIENT HANDSET ...35
3
6
GETTING STARTED 6.1
7
8
36
FLOWCHART ...36
6.2
USING THE PUMP FOR THE FIRST TIME ...36
6.3
POWERING ON ...37
6.4
INSTALLING A SYRINGE...39
6.5
PUMP HEIGHT ...41
PROGRAMMING A PCA INFUSION
42
7.1
PCA INFUSION FLOWCHARTS ...42
7.2
SELECTING A PROFILE ...46
7.3
SELECTING A THERAPY ...46
7.4
SELECTING THE PRESCRIPTION UNIT (VOLUME / DOSE) ...47
7.5
SELECTING A SYRINGE ...47
7.6
SELECTING A DRUG ...48
7.7
SELECTING DRUG CONCENTRATION...48
7.8
SPECIFYING THE PATIENT’S CHARACTERISTICS ...50
7.9
PRIMING THE SYRINGE AND THE EXTENSION SET ...50
7.10
PROGRAMMING A PCA LOADING DOSE ...52
7.11
SELECTING THE PCA MODE ...53
7.12
PROGRAMMING A PCA BOLUS...53
7.13
PROGRAMMING A CONTINUOUS RATE ...54
7.14
PROGRAMMING A PCA INFUSION WITH VARIABLE RATES ...54
7.15
PROGRAMMING AN INFUSION BEYOND SOFT LIMITS ...55
7.16
SETTING THE CUMULATED LIMITS ...56
7.17
REVIEWING THE PCA INFUSION SETTINGS ...57
7.18
STARTING A PCA INFUSION ...58
7.19
SUPERVISING PCA THERAPY ...58
7.20
MODIFYING A RUNNING PCA INFUSION ...62
7.21
ADMINISTERING A BOLUS ...63
7.22
HANDLING PCA ALARMS AND ALERTS DURING PROGRAMMING ...66
PROGRAMMING A GENERAL INFUSION
69
8.1
PROGRAMMING A GENERAL INFUSION BY FLOW RATE ...69
8.2
PROGRAMMING A GENERAL INFUSION BY DOSE RATE ...70
8.3
SELECTING A PROFILE ...71
8.4
SELECTING A THERAPY ...71 4
8.5
9
SELECTING A PROGRAMMING MODE (FLOW RATE OR DOSE RATE)...71
8.6
SELECTING A SYRINGE ...71
8.7
SELECTING A DRUG ...71
8.8
SELECTING DRUG CONCENTRATION...71
8.9
SELECTING THE PATIENT’S CHARACTERISTICS ...72
8.10
PROGRAMMING AN INFUSION BY DOSE ...72
8.11
PROGRAMMING AN INFUSION BY FLOW RATE ...74
8.12
PROGRAMMING AN INFUSION BEYOND SOFT LIMITS ...74
8.13
STARTING AN INFUSION ...75
8.14
MONITORING AN INFUSION ...75
8.15
ADJUSTING THE INFUSION RATE (RATE TITRATION) ...76
8.16
ADMINISTERING A BOLUS ...77
8.17
ADVANCED INFUSION PROGRAMMING MODES...79
8.18
PRE-PROGRAMMING THE PUMP ...81
ENDING AN INFUSION
82
9.1
STOPPING THE INFUSION IN PROGRESS ...82
9.2
COMPLETING AN INFUSION ...82
9.3
UNLOCKING THE PUMP KEYPAD ...84
9.4
POWERING OFF THE PUMP ...84
10 MENUS
85
10.1
OVERVIEW ...85
10.2
PROFILE ...87
10.3
PRESSURE ...87
10.4
KEYPAD LOCK STATUS ...89
10.5
KEYPAD AUTOMATIC LOCK ...91
10.6
BATTERY LIFE ...92
10.7
VOLUME INFUSED / DOSE INFUSED ...92
10.8
PAUSE ...93
10.9
PROGRAMMED BOLUS ...94
10.10 CLINICIAN BOLUS ...94 10.11 PATIENT ...95 10.12 DAY/NIGHT MODE ...96 10.13 VOLUME/TIME AND DOSE/TIME ...97 10.14 VOLUME LIMIT...97 5
10.15 ALARM VOLUME ...98 10.16 VOLUME-DOSE HISTORY ...98 10.17 VIEW FLOW RATE HISTORY ...99 10.18 VIEW PRESSURE HISTORY ...100 10.19 VIEW PCA HISTORY ...100 10.20 VIEW PCA TREATMENT INFORMATION ...101 10.21 VIEW PCA EVENT LOG ...101 10.22 VIEW EVENT LOG...102 10.23 SYRINGE...103 10.24 DATE / TIME ...103 10.25 MAINTENANCE ...104 10.26 LIBRARY INFORMATION ...104 10.27 CLINICAL INFORMATION ...105 10.28 DATA SET ...105 11 ADVANCED PUMP CONFIGURATION
106
11.1
ACCESSING THE PUMP CONFIGURATION OPTIONS ...106
11.2
OPTION GROUPS ...106
11.3
PUMP SETTINGS ...107
12 DATA COMMUNICATION
108
12.1
OVERVIEW ...108
12.2
COMMUNICATION VIA AGILIA CABLES ...108
12.3
COMMUNICATION VIA WI-FI ...109
12.4
DATA SET UPLOAD ...109
13 USER TEST
110
14 ALARMS AND SAFETY FEATURES
111
14.1
INTRODUCTION ...111
14.2
ALARM DESCRIPTIONS ...111
14.3
GENERAL REMARKS ...112
14.4
LIST OF ALARMS ...112
15 SYRINGES
119
15.1
SYRINGE LIST ...119
15.2
PREPARING A SYRINGE ...119 6
15.3
OPERATIONS FOR SYRINGES ...121
15.4
GRAVITY INFUSION IN PARALLEL WITH A PUMP ...122
16 SPECIFICATIONS
123
16.1
ESSENTIAL FEATURES ...123
16.2
PUMP ACCURACY...123
16.3
FLOW RATE SETTINGS ...125
16.4
VOLUME TO BE INFUSED (VTBI) SETTINGS ...125
16.5
DOSE TO BE INFUSED (DTBI) SETTINGS ...126
16.6
INFUSION TIME DISPLAY ...126
16.7
CONCENTRATION ...126
16.8
PATIENT DATA ...127
16.9
PRESSURE MANAGEMENT ...127
16.10 UNITS AND CONVERSION RULES ...128 17 CLEANING AND DISINFECTION
131
17.1
RECOMMENDED AND PROHIBITED AGENTS ...131
17.2
QUICK CLEANING PROCEDURES ...131
17.3
WHEN TO CLEAN AND DISINFECT THE PUMP AND THE PATIENT HANDSET ... 132
17.4
INSTRUCTIONS FOR CLEANING AND DISINFECTION ...132
18 POWER MANAGEMENT
136
18.1
AC POWER SUPPLY PRECAUTIONS...136
18.2
BATTERY PRECAUTIONS ...136
18.3
BATTERY OPERATING MODE ...137
19 TECHNICAL CHARACTERISTICS
138
19.1
POWER SUPPLY ...138
19.2
BATTERY ...138
19.3
POWER CONSUMPTION...138
19.4
COMMUNICATION PORT ...138
19.5
INFRARED COMMUNICATION...139
19.6
SOUND LEVELS ...139
19.7
COMPLIANCE ...140
19.8
DIMENSIONS AND WEIGHT ...140
19.9
TRUMPET AND START-UP CURVES ...140 7
19.10 OCCLUSION ALARM ACCURACY AND BOLUS VOLUME AT OCCLUSION RELEASE143 20 WI-FI
144
20.1
GENERAL INFORMATION ...144
20.2
USAGE RESTRICTIONS IN EUROPE ...145
20.3
TECHNICAL SPECIFICATIONS ...145
20.4
ELECTROMAGNETIC COMPATIBILITY ...145
20.5
PROTOCOLS AND STANDARDS ...146
21 TROUBLESHOOTING
147
22 DEVICE STORAGE, TRANSPORT, AND RECYCLING
149
22.1
PRECAUTIONS FOR STORAGE ...149
22.2
STORAGE AND TRANSPORT CONDITIONS...149
22.3
PREPARING THE DEVICE FOR STORAGE ...149
22.4
USING THE DEVICE AFTER STORAGE ...149
22.5
RECYCLING AT END OF LIFE ...150
23 WARRANTY
151
23.1
GENERAL WARRANTY CONDITIONS ...151
23.2
LIMITED WARRANTY ...151
23.3
WARRANTY CONDITIONS FOR ACCESSORIES ...151
24 GUIDANCE AND MANUFACTURER'S DECLARATION ON EMC
152
24.1
ELECTROMAGNETIC COMPATIBILITY ...152
24.2
ELECTROSTATIC DISCHARGE (ESD) AND PRECAUTIONS TO BE TAKEN .152
24.3
EMC AND ESSENTIAL PERFORMANCE ...153
24.4
ELECTROMAGNETIC COMPATIBILITY AND INTERFERENCE GUIDANCE ...153
25 SERVICING
155
25.1
INFORMATION ON DEVICE SERVICING ...155
25.2
MAINTENANCE REQUIREMENTS ...155
25.3
QUALITY CONTROL ...156
8
26 GLOSSARY OF TERMS
157
APPENDIX: FACTORY CONFIGURATION
159
INDEX
160
9
1
Introduction
1.1 Scope These Instructions for Use (IFU) are applicable to the Agilia SP PCA and Agilia SP PCA WiFi pumps. These devices are referred to throughout this manual as the "Agilia SP PCA". 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 on the cover page and in the Release Notes, page 166.
1.2 Intended Use The Agilia SP PCA syringe pump is primarily intended for PCA therapy, for the administration of analgesic drugs under the patient’s or the clinician’s control. The Agilia SP PCA syringe pump can also be used for general infusions 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. In PCA therapy, it is also intended for use by the patient in order to self administer doses of analgesic agent, after receiving appropriate training and instructions from the clinical staff. It is not intended for use during pre-hospital medical ground transportation.
1.3 Principles of Operation Agilia SP PCA 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 PCA is a transportable and reusable device that can be used every day. The size of a syringe can be 5, 10, 20, 30 or 50/60 mL. For a comprehensive list, refer to the System Components booklet and information provided in Section 15.1, page 119. Agilia SP PCA can be used for bolus administration or continuous infusions. 10
Agilia SP PCA is used with the patient handset (applied part) for PCA therapy Agilia SP PCA 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: Infusion products
Medication
Parenteral fluids
Transfusion
Analgesic drugs Antibiotics Chemotherapy Catecholamines Short acting drugs Anesthesia drugs Diluted drugs Other diluted IV drugs Standard solutions Colloids Parenteral nutrition Blood Red blood cells Platelets Plasma Albumin
General infusion
PCA
-
-
-
When using Agilia SP PCA 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 PCA 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.
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. 11
The only bolus function with the handset can be used safely by patients, who must have the proper physical and mental abilities and have received appropriate training by the clinical staff. The typical initial training duration for healthcare professionals is:
1 hour for the PCA interface. 1 hour for general infusion. It is recommended that healthcare professionals attend a refresher training session of about 30 minutes every year. For training, contact your Fresenius Kabi sales representative.
1.6 Intended Patients Agilia SP PCA is intended to be used in accordance with the healthcare facility’s protocols on patients with the following characteristics: PCA therapy
General infusion Male Female
Sex
Neonates Pediatrics Adults Elderly
Pediatrics Adults Elderly
Age
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. 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.
12
1.7 Contraindications The use of the Agilia SP PCA for PCA therapy requiring the patient handset is contra-indicated for neonates, and for patients that have physical or mental inabilities to handle the handset.
1.8 Use Environment Agilia SP PCA is intended for use in healthcare facilities, under the supervision of trained healthcare personnel. The pump must be used in the following operating 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 modify the pump (except in the case of operations recommended by Fresenius Kabi). WARNING Do not use the pump with the following fluids: Flammable liquids Fluids not suitable for infusion WARNING Do not use the pump in the following environments: Explosive or flammable environments High humidity environments (shower, bath, etc.) Ultrasonic environments Ambulances Magnetic Resonance Imaging (MRI) Hyperbaric chambers WARNING Do not use the pump for the following purposes: Infusion in association with a dialyzer or ECMO Enteral nutrition WARNING While the pump is infusing a patient, do not connect a computer installed with Agilia Partner software to perform technical operations.
13
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.
14
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.
Vigilant Master Med
Medication Safety Solution DERS or Dose Error Reduction 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
Agilia Link Link+ Agilia
Stacking Rack Systems Rack systems designed to stack 4, 6 or 8 Agilia infusion pumps. Agilia Link 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 15, page 119
Accessories
Agilia Duo
Two Channel Accessory Accessory designed to stack 2 Agilia infusion pumps and centralize the power supply.
Pump
Software
INFORMATION For a list of compatible accessories, disposables and software, and for ordering information, refer to the System Components booklet. INFORMATION The Agilia Connect Infusion System is made up of medical devices that are subject to medical device regulations and market authorizations. Some devices, including software products, may not be available in your country at the time of publishing this document. 15
3
Description
3.1 Pump Front View This section shows the Agilia SP PCA pump with the cover closed and with the cover open.
8
1
7 BOLUS
6
2
3
4
5
Legend
1
Handle
21
Syringe barrel clasp
3
Cover clasp
41
Plunger driver
53
Disengagement lever
63
Syringe guard
7
Patient handset
8
Cover lock
Figure 3.1: Front view with cover closed Legend BOLUS
1
2
3
Figure 3.2: Front view with cover open
16
1
Clear protective cover
21
Cover clasp
3
Syringe flange cradle
3.2 Pump Back View Legend
9
1
Cord stowage
8
21
Patient handset and holder
3
Release button
41
Pole clamp lock
53
Rotating pole clamp
63
RS232 communication port
7
Power cord inlet
8
Infrared cell
9
Attachment lock knob
7
BOLUS
6 1 2
3
4
5
Figure 3.3: Back View Symbol
Location
Description
Warning Near power cord inlet
See Section 19, page 138
Near RS232 communication port
Warning
See Section 12, page 108
3.3 Pump Bottom View (Device Identification Label) BOLUS
Figure 3.4: Bottom view For information on symbols used on the device identification label, see Symbol Descriptions, page 2. 17
3.4 Patient Handset 2
1
Legend
BOLUS
3
4
1
Bolus start button
21
Blue LED on when patient handset is connected to pump (stays lit at all times to enable patient to locate handset)
3
Cable gland
4
Wrist strap
Figure 3.5: Patient handset and wrist strap
3.5 Keypad Description 1 2
17
3
16
4
15 14
5
6
7
8
9
10 11
12
13
Legend
1
Screen
7
Fast increment
13
Stop
21
Battery charge status indicator
8
Increment
14
Cancel value / Move back to previous field
3
Power supply indicator
9
Infusion indicator lights
15
Menu
41
Wi-Fi symbol
10
Decrement
16
PCA history
53
On / Off
11
Fast decrement
17
Alarm silence
63
Bolus / Prime
12
Confirm value / Move to next field
Figure 3.6: Keypad description 18
3.5.1
Keypad Details
Table 3.7: Selection Keys Key
Description Arrow keys Keys for setting 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. Table 3.8: 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. Low and medium priority yellow lights can be combined with green flashing lights, which indicates infusion is still running.
The frequency of flashing varies according to flow rate. Table 3.9: Status Indicators 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.
19
3.6 Display and Symbols Table 3.10: 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) Animated symbol displayed when the pump is infusing a drug from a drug library. Infusion stopped STOP remains in the center of the screen until the user starts the infusion again.
Table 3.11: Screen options 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.
Table 3.12: Navigation Buttons Symbol
Description
start
Start
end
End
OK
Confirm
enter
Access function
New ?
Access function and clear settings
exit
Exit function
20