Agilia SP Range Technical Manual sw ver 2.2 Jan 2017

Symbol Descriptions Warning (Refer to the Instructions for Use)

Name and address of the manufacturing facility

Refer to the Instructions for Use

Name and address of the manufacturer / Date of manufacture

Product reference / part number

Protection against electric shock: class II

Product serial number

Non-ionizing electromagnetic radiation

Input terminal - connector

IP22

0123

CE mark

Output terminal - connector

Fragile, handle with care

Electrical fuses

This way up

Alternating Current (AC)

Keep away from rain

Direct Current (DC)

Temperature limitation

Index of protection against ingress of water or particulate matter

Humidity limitation

Not for use in residential areas

Atmospheric pressure limitation

Part included in a recycling process

General symbol for recyclable material

Protection against leakage current; defibrillationproof type CF applied part

Eco packaging symbol

_____________________________________________________________________________________ WARNING Warning of a potential hazard that could result in serious personal injury and/or product damage if the written instructions are not followed

INFORMATION Recommendations to be followed.

2

11378-5_TM_Agilia_SP_Eng

Table of Contents 1

INTRODUCTION 1.1

2

6

SCOPE ... 6

1.2

INTENDED USE ... 6

1.3

PRINCIPLES OF OPERATION ... 6

1.4

INTENDED USERS... 7

1.5

CONTRAINDICATIONS ... 7

1.6

USE ENVIRONMENT ... 7

DESCRIPTION 2.1

8

PHYSICAL DESCRIPTION ... 8 2.1.1 Housing ... 8 2.1.2 Keypad ... 9 2.1.3 Display Board ... 13 2.1.4 CPU Board ... 16 2.1.5 Power Supply Board... 20 2.1.6 AC Power Board... 23 2.1.7 Wi-Fi Board ... 24 2.1.8 Back View... 25 2.1.9 Mechanical Framework Assembly... 25 2.1.10 Mechanical Plunger Driver Assembly... 25

3

4

5

6

2.2

PRINCIPLES OF OPERATION ... 26

2.3

OPERATION DIAGRAM ... 27

FUNDAMENTALS

28

3.1

TRAINING ... 28

3.2

MAINTENANCE SCHEDULE ... 28

3.3

ACCESSING / EXITING THE OPERATING FUNCTIONS ... 29

PROFILE MENU

30

4.1

ACCESSING THE PROFILE MENU ... 30

4.2

PROFILE MENU FUNCTIONS ... 30

BASIC PROFILE CONFIGURATION

32

5.1

ACCESSING THE BASIC PROFILE CONFIGURATION ... 32

5.2

BASIC PROFILE CONFIGURATION FUNCTIONS ... 32

MAINTENANCE OPERATIONS

37

6.1

MAINTENANCE OPTIONS ... 37

6.2

RUNNING TESTS ... 39 6.2.1 Accessing the Tests Menu ... 39 6.2.2 Test 1: Identification ... 40 6.2.3 Test 2: Maintenance... 41 6.2.4 Test 3: Maintenance Messages ... 41 6.2.5 Test 4: Events ... 41 6.2.6 Test 5: Force ... 42 6.2.7 Test 6: Displacement... 44 6.2.8 Test 7: Syringe Barrel Clasp ... 46 6.2.9 Test 8: Battery Info ... 49 6.2.10 Test 9: Indication ... 50 6.2.11 Test 10: Keypad ... 50

3

6.2.12 Test 11: Ageing Test ... 51 6.2.13 Test 12: Battery Life ... 52 6.2.14 Test 13: Battery Test ... 53 6.2.15 Test 20: Pump Code ... 55 6.2.16 Test 21: Power Info ... 55 6.2.17 Test 22: LCD Voltage ... 57 6.2.18 Test 23: Temperature... 57 6.2.19 Test 24: Watchdog ... 58 6.2.20 Test 25: Wi-Fi Module Information ... 59 6.2.21 Checking the Pressure Limit Alarm ... 60 6.2.22 Checking the End of Infusion Alarm ... 61 6.2.23 Control the plunger head detection finger and anti-siphon arms movement... 62 6.2.24 Control the disengagement and plunger head alarms ... 63 6.2.25 Checking the AC Power Supply / Battery Operation ... 65 6.2.26 Electrical Test... 65

6.3

QUALITY CONTROL PROCEDURE... 66 6.3.1 6.3.2

6.4 7

8

9

Running a Quality Control ... 66 Quality Control Certificate ... 69

TESTING THE FLOW RATE ... 70

TROUBLESHOOTING AND MESSAGES

72

7.1

ALARM MESSAGES AND INFORMATION SIGNALS ... 72

7.2

TROUBLESHOOTING GUIDE ... 75

7.3

ERROR CODES ... 77

INTERVENTION PROCEDURES

81

8.1

PROCEDURE #1: BATTERY AND BATTERY DOOR - BOOST CAPACITOR DISCHARGE... 82

8.2

PROCEDURE #2: UPPER CASE ... 84

8.3

PROCEDURE #3: DISPLAY BOARD/LCD DISPLAY ... 86

8.4

PROCEDURE #4: CPU BOARD ... 88

8.5

PROCEDURE #5: POWER SUPPLY BOARD AND AC POWER BOARD ... 91

8.6

PROCEDURE #6: WI-FI BOARD ... 94

8.7

PROCEDURE #7: SYRINGE BARREL CLASP... 97

8.8

PROCEDURE #8: SYRINGE DETECTION SYSTEM ... 101

8.9

PROCEDURE #9: MOTOR ... 105

8.10

PROCEDURE #10: DISENGAGEMENT FLEXIBLE CIRCUIT ... 108

8.11

PROCEDURE #11: FORCE SENSOR + RIBBON CABLE KIT ... 113

8.12

PROCEDURE #12: LINEAR SENSOR KIT... 118

8.13

PROCEDURE #13: PLUNGER COVER AND LEVER KIT ... 122

8.14

PROCEDURE #14: PLUNGER KIT ... 124

8.15

PROCEDURE #15: CARRIAGE KIT ... 128

CLEANING AND DISINFECTING

132

10 DEVICE STORAGE

133

11 POWER MANAGEMENT

134

4

12 TECHNICAL CHARACTERISTICS 12.1

135

POWER SUPPLY ... 135

12.2

BATTERY ... 135

12.3

POWER CONSUMPTION ... 135

12.4

COMMUNICATION PORT ... 136

12.5

INFRARED COMMUNICATION ... 136

12.6

AGILIA USB CABLE ... 136

12.7

COMPLIANCE ... 136

12.8

DIMENSIONS - WEIGHT ... 137

12.9

ELECTRONIC BOARDS ... 137

12.10 MATERIAL CHARACTERISTICS ... 137 13 SPECIFICATIONS

138

14 RECYCLING

139

15 WARRANTY

140

16 GUIDANCE AND MANUFACTURER'S DECLARATION ON EMC

141

17 SPARE PARTS CATALOG

142

18 ORDERING INFORMATION

143

18.1

DATA MANAGEMENT CABLES... 143

18.2

ASSOCIATED SOFTWARE ... 143

18.3

DISPOSABLES ... 143

19 GLOSSARY OF TERMS

144

INDEX

147

5

1

Introduction

1.1 Scope This technical manual is applicable to the Agilia SP range:

    

Agilia SP Agilia SP MC Agilia SP MC WiFi Agilia SP TIVA Agilia SP TIVA WiFi

The user must adhere to the instructions specified in this technical manual. Failure to adhere to these instructions may result in damage to the equipment, injury to patients or injury to users. Certain functions and options described in this technical manual differ from one infusion pump version to another (Agilia SP, Agilia SP MC, Agilia SP MC WiFi, Agilia SP TIVA, Agilia SP TIVA WiFi), and according to the destination country. WARNING Check that this technical manual is applicable to the current software version of the device.  The software version of the device is displayed on the startup screen.

 The software version described in this document is displayed in the Release Notes at the end of this document.

1.2 Intended Use The Agilia Connect Infusion System is dedicated to the intermittent or continuous delivery of parenteral fluids (such as solutions, colloids, parenteral nutrition) and medications (such as diluted drugs, chemotherapy, anesthesia drugs) and transfusion of blood and blood derivative products. Infusions can be performed on adult, pediatric and neonatal patients through clinically accepted routes of administration (such as intravenous, intra-arterial, or subcutaneous routes) in healthcare facilities, by trained healthcare professionals, and according to healthcare facility protocols. The Agilia SP range 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.

1.3 Principles of Operation The Agilia SP range is a programmable electronic medical system dedicated to administering a predetermined 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 range 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. The Agilia SP range can be used for intermittent or continuous infusions. The Agilia SP range is intended for use on only one patient at a time. It can be reused indefinitely on multiple patients throughout its lifetime. For more information, refer to the Instructions for Use of the relevant pump.

6

1.4 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. Service and maintenance must only be performed by biomedical engineers or technicians, or by IT specialists. Technical maintenance tasks (including inspections and checks) are performed by trained biomedical engineers, or by dedicated medical rental and/or service organizations who have been trained and approved by the manufacturer. For training, contact your Fresenius Kabi sales representative.

1.5 Contraindications  While being serviced, the device must not be connected to a patient.  Do not modify the pump (except in the case of operations recommended by Fresenius Kabi). For more information, refer to the Instructions for Use of the relevant pump.

1.6 Use Environment Pumps must be used in the operating conditions (temperature, pressure, humidity and altitude) specified in their Instructions for Use. Refer to the Instructions for Use of the relevant pump.

7

2

Description

2.1 Physical Description 2.1.1

Housing

1

9 1

8

7

2

3

3 4

6

5

9 Figure 2.1: Housing Legend 1

Cover

6

Disengagement Lever

2

Keypad

7

Syringe Guard

3

Base

8

Syringe Flange Cradle

4

Syringe Barrel Clasp

9

Angle Bracket

5

Plunger Driver

The Agilia SP range of pumps is made up of 3 main parts: a cover, a base and an angle bracket.

 The cover contains the following: - Display board - Keypad

 The base supports the following: - CPU board - Mechanical framework assembly - Plunger driver unit - Wi-Fi board (for Wi-Fi infusion pumps)

 The angle bracket supports the following: - Power supply board - AC power board - Battery - Fixing clamp system

8

2.1.2

Keypad There are different keypads depending on the pump's model and country of destination.

1 2

14

3 4 13

4

5

6

7

8

9

10

11

12

Figure 2.2: Keypad for Agilia SP Legend 1

Screen

8

Infusion Indicator Lights

2

Battery Charge Status Indicator

9

Decrement

3

Power Supply Indicator

10

Fast Decrement

4

On / Off

11

Confirm Value / Move to Next Field

5

Bolus / Prime

12

Stop

6

Fast Increment

13

Menu / Cancel Value / Move Back to Previous Field

7

Increment

14 3

Alarm Silence

9

1 2

17

3

16

4

15 14

5

6

7

8

9

10 11

12

13

Figure 2.3: Keypad for Agilia SP MC Legend

10

1

Screen

10

Decrement

2

Battery Charge Status Indicator

11

Fast Decrement

3

Power Supply Indicator

12

Confirm Value / Move to Next Field

4

Wi-Fi Symbol (for Wi-Fi pumps only)

13

Stop / Pause

5

On / Off

14 3

Cancel Value / Move Back to Previous Field

6

Bolus / Prime

15 3

Menu

7

Fast Increment

16 3

Pressure Menu

8

Increment

17 3

Alarm Silence

9

Infusion Indicator Lights

1 2

17

3

16

4

15

SP

14

5

6

7

8

9

10 11

12

13

Figure 2.4: Keypad for Agilia SP TIVA Legend 1

Screen

10

Decrement

2

Battery Charge Status Indicator

11

Fast Decrement

3

Power Supply Indicator

12

Confirm Value / Move to Next Field

4

Wi-Fi Symbol

13

Stop

5

On / Off

14 3

Cancel Value / Move Back to Previous Field

6

Bolus / Prime

15 3

Menu

7

Fast Increment

16 3

Graph

8

Increment

17 3

Alarm Silence

9

Infusion Indicator Lights

11

1 2

16

3

15

4

14

SP

13

4

5

6

7

8

9

10

11

12

Figure 2.5: Keypad for Agilia SP TIVA, Japanese market Legend

12

1

Screen

9

Decrement

2

Battery Charge Status Indicator

10

Fast Decrement

3

Power Supply Indicator

11

Confirm Value / Move to Next Field

4

On / Off

12

Stop / Pause

5

Bolus / Prime

13

Cancel Value / Move Back to Previous Field

6

Fast Increment

14 3

Menu

7

Increment

15 3

Graph

8

Infusion Indicator Lights

16 3

Alarm Silence

2.1.3

Display Board The display board is located under the front of the command panel, and contains all essential parts for human-machine interaction:

 Keypad  Synoptics and control indicators  LCD screen This board is connected to other parts with the connectors shown below.

J2 J1

J3 Figure 2.6: Display Board Legend J1

J1 Connector to Keypad

J2

J2 Connector to CPU Board

J3

J3 Connector to LCD Display

13

J1 Connector to Keypad Pin n°

Signal

Description

1

GND

Ground

2

KBD_COL_0

Column 0

3

KBD_COL_1

Column 1

4

KBD_COL_2

Column 2

5

KBD_LINE_0

Line 0

6

KBD_LINE_1

Line 1

7

KBD_LINE_2

Line 2

8

TON/OFF

On/Off key

9

KBD_LINE_3

Line 3

10

GND

Ground

11

GND

Ground

12

GND

Ground

J2 Connector to CPU Board Pin n°

Signal

Description

1

GND

Ground

2

PRES_BOARD/

HMI board presence detection

3

+3V3

+3.3V power supply

4

+3V3

+3.3V power supply

5

ANA_VLCD

LCD charge pump voltage

6

GND

Ground

7

S_ANA_DOOR

Door close detection

8

RESET/

Global reset

9

GND

Ground

10

CS_LED-KBD/

LED or keypad selection

11

CS_LCD/

LCD selection

12

GND

Ground

13

LCD_CD

LCD type of the interface cycle: Control/Data (0:control, 1:data)

14

LCD_MS

LCD mode selection

15

GND

Ground

16

HMI_MOSI_SDA

SPI data written / I²C data for HMI board

17

GND

Ground

18

HMI_MISO

SPI data read for HMI board

19

GND

Ground

20

HMI_SCK_SCL

SPI/I²C clock for HMI board

21

GND

Ground

22

KON-OFF

On/Off key

23

+5V

+5V power supply

24

+5V

+5V power supply

25

CMD_FAIL

LED command failure

26

GND

Ground

14

J3 Connector to Display Pin n°

Signal

Description

1

GND

Ground

2

A

Anode of the backlight (+5V)

3

K

Cathode of the backlight

4

GND

Ground

5

SCK

SPI clock (HMI_SCK_SCL signal)

6

GND

Ground

7

SDA

SPI data (MOSI) (HMI_MOSI_SDA signal)

8

GND

Ground

9

CD

Control/Data (0:control, 1:data) (LCD_CD signal)

10

GND

Ground

11

/RST

Reset (RESET/ signal)

12

GND

Ground

13

CS0

Chip select (CSLCD/ signal)

14

GND

Ground

15

BM0/DB13

Mode select (LCD_MS signal)

16

GND

Ground

17

VLCD

Charge pump voltage (ANA_VLCD signal)

18

GND

Ground

19

+3V3

+3V3 power supply

20

GND

Ground

21

GND

Ground

22

GND

Ground

15

2.1.4

CPU Board The CPU board consists of a main microcontroller, FLASH and RAM memories, and various analog or power functions, such as:

 One single-step bipolar motor command  Adjustment of and acquisition from different detectors  Different lines of communication (synchronous and asynchronous serial links). The CPU Board is connected to the Display Board with the J3 connector. A ribbon cable connects it to the Power Supply Board with the J6 connector.

J1

J2

J3 J5 J4

J6

J7

J8

Figure 2.7: CPU Board (Front View)

J9

Figure 2.8: CPU Board (Back View) Legend J1

J1 Connector - Connection to Syringe Barrel Clasp (potentiometer and flange switch)

J6

J2

J2 Connector - Connection to Linear Displacement Potentiometer

J7

J3 J4 J5

16

J3 Connector - Connection to Display Board J4 Connector - Connection to Wi-Fi Board if one is present J5 Connector - Connection to Opto Motor

J6 Connector - Connection to Power Supply Board J7 Connector - Connection to Motor

J8 J1

J8Connector - Connection to JTAG Connector (micro programming)

J9

J9 Connector - Connection to Plunger Driver (force sensor and disengagement opto switch)

J1 Connector to Syringe Barrel Clasp Pin n°

Signal

Description

1

GND

Ground

2

SW_OUT

Flange switch state

3

SW_IN

Flange switch power supply

4

DIA+

+3.3 V power supply

5

DIA_OUT

Syringe barrel clasp potentiometer value

6

DIA-

Ground

J2 Connector to Displacement Linear Potentiometer Pin n°

Signal

Description

1

DISP-

Ground

2

DISP_OUT

Displacement potentiometer status

3

DISP+

+3.3 V power supply

J3 Connector to Display Board Pin n°

Signal

Description

1

GND

Ground

2

A

Anode of the backlight (+5V)

3

K

Cathode of the backlight (K_BACKL signal)

4

GND

Ground

5

SCK

SPI clock (HMI_SCK_SCL signal)

6

GND

Ground

7

SDA

SPI data (MOSI) (HMI_MOSI_SDA signal)

8

GND

Ground

9

CD

Control/data (0:control, 1:data) (LCD_CD signal)

10

GND

Ground

11

/RST

Reset (RESET/ signal)

12

GND

Ground

13

CS0

Chip select (CSLCD/ signal)

14

GND

Ground

15

BM0/DB13

Mode select (LCD_MS signal)

16

GND

Ground

17

VLCD

Charge pump voltage (ANA_VLCD signal)

18

GND

Ground

19

+3V3

+3V3 power supply

20

GND

Ground

21

GND

Ground

22

GND

Ground

17

J4 Connector to Wi-Fi Board (for Wi-Fi pumps only) Pin n°

Signal

Description

1

Floating

Not used on Agilia VP range. Leave floating

2

Floating

Not used on Agilia VP range. Leave floating

3

GND

Ground

4

Floating

Not used on Agilia VP range. Leave floating

5

Floating

Not used on Agilia VP range. Leave floating

6

GND

Ground

7

WIFI_VCC

+3V3 Wi-Fi power supply

8

WIFI_VCC

+3V3 Wi-Fi power supply

9

UART-RxD

Receive data

10

UART-TxD

Transmit data

11

UART-RTS

Hardware flow control (request to send)

12

UART-CTS

Hardware flow control (clear to send)

13

GND

Ground

14

GND

Ground

J5 Connector to Opto Motor Pin n°

Type

1

Power

2 3

Signal

Description

GND

Ground

Input

OP_OPTO

Analog output signal of the photomicrosensor (photo-transistor collector)

Power

GND

Ground (photo-transistor emitter)

4

Power

GND

Ground (photo-diode cathode)

5

Output

OP_CD_OPTO

Power supply signal of the photomicrosensor (photo-diode anode)

6

Power

GND

Ground

J6 Connector to Power Supply Board Pin n°

Signal

Description

1

GND

Ground

2

PRES_BOARD/

HMI board presence detection

3

+3V3

+3V3 power supply

4

+3V3

+3V3 power supply

5

ANA_VLCD

LCD charge pump voltage

6

GND

Ground

7

S_ANA_DOOR

Door close detection

8

RESET/

Global reset

9

GND

Ground

10

CS_LED-KBD/

LED or keypad selection

11

CS_LCD/

LCD selection

12

GND

Ground

13

LCD_CD

LCD type of the interface cycle: Control/data (0:control, 1:data)

14

LCD_MS

LCD mode selection

15

GND

Ground

16

HMI_MOSI_SDA

SPI data written/I²C data for HMI board

17

GND

Ground

18

HMI_MISO

SPI Data read for HMI board

19

GND

Ground

20

HMI_SCK_SCL

SPI/I²C clock for HMI board

21

GND

Ground

22

KON-OFF

On/Off key

23

+5V

+5V power supply

18

Pin n°

Signal

Description

24

+5V

+5V power supply

25

CMD_FAIL

LED command failure

26

GND

Ground

J7 to Motor Connector Pin n°

Signal

Description

1

MOTP_OUT1B

Output B of the coil 1

2

MOTP_OUT1A

Output A of the coil 1

3

MOTP_OUT2A

Output A of the coil 2

4

MOTP_OUT2B

Output B of the coil 2

5

GND

Ground

6

GND

Ground

J8 to JTAG Connector (micro programming) Pin n°

Signal

Description

1

GND

Ground

2

+3V3

+3.3V power supply

3

TRST/

Test reset

4

TDO

Test data output

5

GND

Ground

6

TDI

Test data input

7

MR/

Manual reset

8

TMS

Test mode select

9

TCK

Test clock

10

GND

Ground

J9 Connector to Plunger Driver Pin n°

Signal

Description

1

GND

Ground

2

PLGH_OPTO/

Analog output signal of the piston photomicrosensor

3

FORCE -

Negative input of the force sensor

4

FORCE +

Positive input of the force sensor

5

+3V3

3V3 power supply of force sensor

6

DSG_OPTO/

Analog output signal of the release photomicrosensor

7

PLGHDSG_CD_OPTO

Power supply signal of the photomicrosensors

8

DSG_SW_ON/

Analog output signal of the release switch

9

DSG_SW_OFF/

Analog output signal of the release switch

10

GND

Ground

19

2.1.5

Power Supply Board The power supply board consists of he following:

 An ATtiny26L secondary microcontroller associated with the one on the CPU board.  Different analog or power functions, including: - Power supply management for all boards - Battery charger - Infrared interface - Separate lines of communication (internal and external) to the boards - Speaker - Buzzer - Super-capacitor The power supply board is located on the angle bracket. See figure 2.1, page 8. It supplies power to the electronic unit from the 100 V - 240 V AC network, or from 9 V DC. It also charges a 2.2 Ah battery. This board is connected to other parts with the connectors shown below.

J1

J2

Figure 2.9: Power Supply Board (Front View)

J5 J3

J4 Figure 2.10: Power Supply Board (Back View) Legend J1

J2 J3

20

J1 Connector - Connection to CPU Board J2 Connector - Connection to microphone, speaker and external plug (RS232 Communication Port and DC Power Input/Output) J3 Connector - Connection to Internal Battery

J4

J4 Connector - Connection to Secondary Microcontroller J5 Connector - Connection to AC Power Board

J5