Injectomat Agilia Instructions for Use July 2010

Contents 1. INTRODUCTION ... 4 Intended use ... 4 Precautions to be taken ... 4 2. DESCRIPTION OF INJECTOMAT® AGILIA ... 5 3. OPERATIONS FOR USE ... 7 4. DISPLAY AND SYMBOLS... 12 5. ALARM AND SAFETY FEATURES ... 14 6. MENU ... 16 Permanent menu ... 16 Menu to be selected in option mode... 17 7. OPTION ... 18 8. DRUGS... 20 Introduction ... 20 Infusion mode: Volume/time and limit volume ... 21 Display and symbols... 23 Safety features and warnings ... 23 Service Options ... 23 Drug library ... 24 9. USER TEST... 25 10. PERFORMANCES ... 26 Rates range ... 26 Volume Limit ... 26 Volume/Time... 26 Syringe list ... 27 Accuracy ... 27 Programmable pause ... 27 Pressure management ... 28 Occlusion alarm response time and Bolus volume at occlusion release ... 29 11. TECHNICAL CHARACTERISTICS... 30 Electrical powers... 30 Battery ... 30 Communication port... 30 Infrared communication ... 30 Compliance... 30 Dimensions - Weight... 31 Trumpet curves... 31 12. GUIDANCE AND MANUFACTURER’S DECLARATION ON EMC ... 32 Electromagnetic emissions - Table 201... 32 Electromagnetic immunity - Table 202 ... 32 Electromagnetic immunity - Table 204 ... 33 Recommended separation distances between portable and mobile RF communication equipment and Injectomat® Agilia - Table 206... 34 2

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13. CLEANING AND USE CONDITIONS ... 35 Cleaning and disinfecting... 35 Environmental conditions... 35 Use of the internal battery... 35 Recommendations... 36 14. SERVICES... 37 Conditions of guarantee... 37 Quality control... 37 Preventive maintenance ... 37 Servicing ... 37 Data racks, accessories and maintenance tools ... 38

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1. Introduction Injectomat® Agilia is the first syringe pump of the Agilia range, our new generation of infusion pump. It is simple to use and training is fast thanks to its ergonomics and interactive screens. Very intuitive, Injectomat® Agilia was also developed to promote safety. The pusher protection "Push-guard" offers a maximum safety in case the pump falls. The monitoring of pressure as well as many safety features optimize the operation of Injectomat® Agilia. Robust and adaptable thanks to a wide choice of options, Injectomat® Agilia makes it possible to answer the whole of your needs.

Intended use

Injectomat® Agilia is a syringe pump for intravenous drug infusion.

This pump must be used by professionals working in hospitals.

Precautions to be taken The symbol

visible on the device, recommends this user guide should be completely read.

Injectomat® Agilia was tested in accordance with the applicable standards of electromagnetic compatibility of the medical devices. Its immunity makes it possible to ensure correct operation. The limitation of the emitted radiations avoids the undesirable interference with other equipments such EEG, ECG, … If Injectomat® Agilia is placed near devices like surgical equipment HF, X-rays, NMR, mobile phones, Wifi points..., minimal distances between equipment are essential (see page 33). The device must not be used in presence of inflammable anaesthetic agents due to a risk of explosion. It should always be used away from all risk areas. The device can be disturbed by pressure or pressure variations, mechanical shocks, heat ignition sources, etc. If you wish to use the devices in a specific condition, please contact our After-Sales Department. The pump must be used in a horizontal and stable position to work correctly. The physiological effects of medicine can be influenced by the characteristics of the device and disposable syringe. Check that they are compatible with prescriptions, the characteristics of trumpet curves and occlusion alarm setting times in relation to the programmed flow rate. In case of unexpected situation in the pump controls or environment, the state of the art safe-design is to alarm, to stop infusion and to display an error code. The user is invited to be aware of those alarms (see Chapter 6). In case where the device is used to deliver life sustaining therapies, like short half-life medications, the user should consider adequate provisions for back-up therapy delivery solutions.

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2. Description of Injectomat® Agilia

1

2

3

4 5 6

7

10

11

9

8

1 - Syringe barrel clasp

5 - Handle

9 - Mains connection

2 - Syringe flange cradle

6 - Assembly bolt

10 - Fixing button

3 - Pusher

7 - Infrared cell

11 - "Swinglock clamp"

4 - "Push-guard"

8 - Communication port and DC power input-output

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5

12

15

13

16

17

18

19

12 -

Mains warning

13 -

Screen

14 -

Silence Alarm

20 -

15 -

ON/OFF

21 -

16 -

Bolus or Prime

6

14

20 21 22

17 to

Value selection

23

24

22 -

Validation

23 -

Stop: infusion stop

24 -

Menu / Exit

Functioning, pre-alarm and alarm warnings

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3. Operations for use

Installation of Injectomat® Agilia Injectomat® Agilia can be used on a table, pole or rail.

On table

Two " Injectomat® Agilia " maximum can be assembled together during infusion

On pole

On rail

Three devices maximum can be assembled on a pole or during transportation

When the devices are assembled, the assembly bolts must be in closed position. 3 pumps on a pole: at least 2 fixing clamps must be locked.

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Using the fixing clamp The swinglock clamp is only orientable when closed against the pump. It is maintained in its vertical or horizontal position with the fixing button. The following images show how to modify the pump installation, from a pole to a rail position. Unscrew the clamp screw (A) and disengage the device from the pole. Push the fixing button (B).

Fold the fixing clamp against the pump. This is the recommended position for the swinglock clamp when the device is placed on a flat surface.

B

A

Rotate the fixing clamp downward through 90 degrees.

Move the fixing clamp outward (A). The fixing button is released automatically. Engage the device on the rail and use the clamp screw (B) to secure it.

A

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B

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Installing a syringe (patient not connected) Connect the extension set to the syringe according to proper practices. Check that there is no air bubble left in the syringe.

Place the syringe in its cradle, the flanges correctly inserted in the provided slot . Secure the syringe with the syringe barrel clasp.

Move the pusher forward to the syringe head.

Check the general installation.

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1 - Operations for use

2 - Syringe selection

Check Injectomat® Agilia is not damaged. Connect the power supply cord to the main source and to the syringe pump: the mains warning lights up. Press the <ON> key to turn the pump ON. For the first startup, refer on page 35: Use of the internal battery. Press the <OFF> key continuously to turn the pump OFF. To disconnect the device from mains supply, disconnect mains-wise plug first before unplugging the device power inlet.

The installed syringe must correspond to the syringe displayed. OK: to confirm syringe, or, C: to change syringe selection then confirm.

3 - Prime

4 - Flow rate selection/start

Connect the extension set to the syringe. Check the patient is not connected. To start the prime, press the <PRIME> key twice: one short press, then one continuous press until all air bubbles are eliminated from the line. To stop the prime, release the <PRIME> key. Connect the patient. Note: During priming, the occlusion pressure level is set to its maximum value (900 mmHg).

Select flow rate. Check the infusion parameters (syringe, flow rate, …). Start: press the <VALIDATION> key to start infusion.

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Silence alarm

Access to the menu

Press the <MENU/EXIT> key to have access to the following functions: Infused volume, Pressure, Battery life, Pause, Preventive silence: to change a syringe without any Locking, … Other functions are described page 16. audible signal, stop infusion pressing the <STOP> key. Press the <SILENCE ALARM> keys and change the syringe. Press the <SILENCE ALARM> key to silence the audible signal.

Bolus

Pause

Press the <BOLUS> key twice to start bolus (1 short press + 1 continuous press). Bolus stop: release the key.

Press the <STOP> key: the infusion stops. Start infusion pressing the <VALIDATION> key. Pause programming: press the <STOP> key twice. Select the pause duration. The pause can also be programmed from the menu. When the pause duration is finished, press the <VALIDATION> key to start infusion.

Selection of a bolus rate Press the <BOLUS> key until the flow rate flashes. Select the bolus rate (ml/h) and confirm. Note: During bolus, the occlusion pressure level is set to its maximum value (900 mmHg).

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4. Display and symbols Injectomat® Agilia displays the infusion parameters in progress through specific symbols. Infusion in progress

Continuous display

or

Main indicator lights provide information on status of the infusion in progress.

Pause

The symbol flashes when activated.

Battery life

Appears when the device is operating on battery. Three different levels of charge are symbolized.

Mains constant yellow Infusion in progress Indicator lights Pre-alarm Alarm

flashing green

Main indicator lights provide information on status of the infusion in progress.

flashing orange flashing red

Start Validation Access to function Help

Previous screen

These symbols help the user in programming the pump.

Cancel Change syringe selection Selected Not selected Mains disconnection alarm Alarms and safeties features

Pressure increase

Main symbols for alarm and safety features.

Pressure drop

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Fast increment key Increment key Selection keys

Keys for selection of flow rate (ml/h), volume limit (ml), … values.

Decrement key Fast decrement key Fast access to maximum values

+

Fast access to minimum values

+

Infused volume Battery life Keyboard locking Maintenance Date/Hour Data event log MENU

Syringe

The menu is dedicated to infusion options that are selected by the user.

Sound level Volume limit Volume/Time Pause Pressure Night mode

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5. Alarm and safety features Injectomat® Agilia has a continuous inspection system that functions as soon as the pump is in use. Visual messages are displayed to understand the alarm cause. Press on to silence alarm according to table below. Control

Visual message

Infusion stop

Silence alarm

BATTERY PRE-ALARM

NO

YES

Low battery. Note: Battery alarm activated when at least 30 minutes battery life remaining. (If the battery has previously been charged).

BATTERY ALARM

YES

YES (2 min)

Discharged battery. Note: The pump will turn OFF automatically within 5 minutes. Connect the pump to the mains.

POWER DISCONNECTION

NO

YES

Mains disconnection. (Alarm Selection : refer [Par 13], page 19.

SYRINGE INSTALLATION

YES

YES (2 min)

Pusher or syringe barrel clasp or flange detection.

YES

YES (2 min)

Syringe not correctly installed. Note: The alarm goes OFF as soon as the installation is correct. A silence alarm of 2 min is automatically activated when the pump is switched on.

END OF INFUSION PRE-ALARM

NO

YES

The pre-alarm is triggered when the time before end of infusion is less than 5 min and the remaining volume in the syringe is less than 10% of the syringe capacity.

END OF INFUSION ALARM

YES

YES

Empty syringe.

END OF LIMIT VOLUME PREALARM

NO

YES

The pre-alarm is triggered when the time before end of volume limit is less than 5 min and the remaining volume in the syringe is less than 10% of the syringe capacity.

Stop/KVO/ continuous

YES (*)

Limit volume reached. (*) Silence duration for KVO: page 18

Battery

Mains

Installed syringe

Infusion

Volume Limit

Activation

END OF LIMIT VOLUME ALARM

The maximum volume that may be infused under single fault condition is 1 ml.

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Control

V/T

Pressure

Visual message

Infusion stop

Silence alarm

Activation

END OF VOL./TIME PREALARM

NO

YES

5 minutes before V/T alarm or 10% of the total syringe capacity.

END OF VOL./TIME ALARM

Stop/KVO/ continuous mode

YES (*)

V/T limit reached. (*) Silence duration for KVO: page 18

OCCLUSION PRE-ALARM

NO

YES

- 50 mmHg from the programmed limit.

OCCLUSION ALARM

YES

YES (2 min)

PRESSURE DROP

NO

YES

Pressure drop in the infusion line. (This alarm can be selected in options).

PRESSURE INCREASE

NO

YES

Pressure increase in the infusion line. (This alarm can be selected in options).

PLUNGER HEAD ALARM

YES

YES

Pusher incorrectly inserted.

DISENGAGEMENT MECHANISM ALARM

YES

YES

Disengaged mechanism.

FLASHING FLOW RATE

NO

---

Flashing starts 3 seconds after no confirmation of selection. An audible alarm is activated 15 seconds afterwards.

NO VALIDATION

NO

YES

Flashing starts 3 seconds after no confirmation of selection. An audible alarm is activated 15 seconds afterwards.

Audible signal

---

---

No syringe selection > 2 minutes.

---

---

Unauthorized key.

Other alarms

Programmed limit reached.

STOP message

---

---

End of pause duration.

Er - message (Er01, Er02…)

YES

---

Technical alarm. Press the <OFF> key.

In case of malfunction alarm, note the error message (ErXX). Disconnect from the mains and stop the device by pressing the OFF key (10 - 15 seconds can be necessary). If the alarm persists when the device is switched on again, without use on patient, contact the qualified technicians in your establishment or our After-Sales Department.

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6. Menu Operation

Key

Access menu/previous menu: Select with: Confirm with:

___

Selected ⌧ / Not selected

Permanent menu Function

Description

Operation

Symbol

Infused volume

Display of infused volume and total infused volume reset

Clear the infused volume

Pressure

Pressure limit adjustment and DPS mode activation

Pressure limit DPS mode activation

Battery life

Battery life display

Display in hour and minute for a selected rate

Pause

Pause duration adjustment

Hours and minutes adjustment

Locking

Keyboard locking and unlocking

Syringe

Brand capacity and type of the used syringe

Display only if [Par 15] "syringe display" not selected

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Locking The <STOP> and <VALIDATION> keys are never locked. Syringe used

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Menu to be selected in option mode Function

Description

Operation

Volume/time programming

Volume Time End VTI (stop, KVO, continuous)

Maintenance

Information on maintenance, version, functioning duration, etc.

Maintenance date SN (serial number) Software version…

Data Event log Function accessible in STOP mode only

Up to 1500 events recorded

Syringe Pressure limit Flow rate…

Sound level

Audible level adjustment

7 accessible levels

Volume limit

Volume limit programming

Select VL or OFF End VL (stop, KVO, continuous)

Date/hour

Date and hour

dd/mm/yyyy

Night mode

Manual Mode change: night/day or day/night

Volume/Time Function accessible in STOP mode only

Function accessible in STOP mode

Only if "Manual mode" selected in Ward option [Par 18]

Symbol

h/min

Manual mode interrupts auto-mode. Night mode is re-activated on next defined night cycle [Par 18]

CAUTION: the menu can change depending on the selected infusion options.

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7. Option Operation

Key

Options access:

when device is turned off

Option selection: Confirm by:

___

Previous menu Selected ⌧ / Not selected Selected values on use are memorized when the device is turned OFF at end of programming. Option User

Function [Util 1] Screen options Display of the different symbols

[Util 2] Menu options Insertion of the different options in the menu

[Util 3] Contrast

Choice

Description ⌧ /

Battery

Permanent display of battery symbol

Pressure

Display of pressure symbol

Volume info. (or)

Display of infused volume

Time info. (or)

Display of remaining time of infusion

Battery life info. (or)

Display of battery life

Man Moon

Choice of symbol "infusion in progress"

Volume limit

Volume limit selection

Volume/time

V/T selection

Sound level

Audible signal selection

Maintenance

Maintenance selection

Data event log

Display of event log

Date/hour

Date/hour selection

Screen contrast adjustment

[Util 4] Pressure Pressure mode

Variable mode (with maximum and limit)

Dynamic Pressure System

DPS with drop threshold and pressure increase threshold

[Util 5] KVO (Keep Vein Open)

KVO1: OFF, 0.1 to 5 ml/h KVO2: OFF, 0.1 to 5 ml/h Continuous: YES/NO

3 level mode (with thresholds and limit) No DPS mode activation

Silence duration: delay for end of V/T or end of VL re-activation alarm (60 minutes maximum)

Continuous mode: at the end of V/T or VL mode, infusion continues at the current selected rate.

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[Util 7] Date/hour

Date selection: dd/mm/yyyy

[Util 8] Language

Français / English…

Hour selection: h/min

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Option Ward

Functions

Option choice

Ward code

Code: 0000 (default code: 0200).

[Par 1] Beep level

1 tonality

2 tonalities

Key Bip

Preventive silence : refer page 11 "Silence alarm" Silence duration : between 2 alarm bips (0 to 5 seconds) [Par 2] Sound level [Par 3] Initial rate

[Par 4] Maximum rate [Par 5] Syringe selection

7 available audible levels. If option selected: on turning on the pump, the initial rate will be the last selected during the last infusion. If option not selected : 0,00 ml/h display. Per syringe capacity (50cc / 30cc …) Auto confirmation of the syringe or not (available only with a single syringe selected - refer to [Par 6])

[Par 6] Syringes

Available syringe list (activation/disactivation).

[Par 7] Infusion start

Mandatory prime or advised prime

[Par 8] Empty syringe [Par 9] Bolus rates

"OK" flashes at end of infusion pre-alarm or alarm. If confirmed the infusion goes on until the syringe is empty Per syringe capacity (50cc / 30cc …).

[Par 10] Ward name

Ward name (press OK for each letter or - until reaching the last position).

[Par 11] Bio name

Biomedical name (press OK for each letter or - until reaching the last position).

[Par 12] User code

User code: mandatory code to modify user options

[Par 13] Mains supply disconnection alarm

Warning beep and message "device operating on battery" when the pump is turned on.

[Par 14] Battery life

Maximum battery life mode: allow the increase of the battery autonomy.

[Par 15] Syringe/ward display

Syringe brand and capacity or ward name display.

Screen [Par 18] Night mode ! manual mode has priority brightness low on auto-mode. Auto-mode re-activated next night cycle

Green lights low

Key beep off

Manual mode: manual switch from one mode to another Auto mode: automatic switch from one mode to another according to the time range settings Maint.

Maintenance

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Code: please contact our technical team.

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8. Drugs Introduction The "drug" function makes the infusion safe, incorporating the drug parameters. The drug library can be created with our Vigilant® Drug'Lib system which makes drug administration safe. Vigilant® Drug'Lib in particular allows the drug concentration, default flow rate, "hard" flow rate limits (limits which cannot be exceeded during the infusion) and "soft" flow rates limits (limits which can be exceeded during the infusion after a user warning message) the permitted infusion modes (Ml/h, V/T) and the bolus parameter setting to be added.

Start-up: Start-up procedures 1 and 2 page 10. 3 - No drug selection

Or select drug

No drug : Select "no drug" Ok: Press <VALIDATION>. Follow the standard set up procedure (page 10)

Select drug Select the drug. Ok: Press <VALIDATION> to confirm the choice of drug.

4 - Prime (optional)

5 - Select flow rate/start

Connect the extension to the syringe. Check that the patient is not connected. To start the prime, press the <PRIME> key twice: one short press, then one continuous press until all air bubbles are eliminated from the line. To stop the prime, release the <PRIME> key. Connect the patient. Note: During priming, the occlusion pressure level is set to its maximum value (900 mmHg).

Select the flow rate with the increment keys. Check the infusion parameters (syringe drug name and parameters, flow rate etc.) Start Press <VALIDATION> to start the infusion.

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