Injectomat MC Agilia Instructions for Use 2857-4 July 2010

Contents 1. INTRODUCTION ... 4 Programming modes ... 4 Infusion modes ... 4 Intended use ... 5 Precautions to be taken ... 5 2. DESCRIPTION ... 6 3. INSTALLATION ... 8 4. OPERATIONS ... 11 General operations ... 11 No drug name and Drug labelling modes ... 13 Flow rate mode... ... 14 or Dose rate mode (1/3)... 14 Dose rate mode (2/3)... 15 Dose rate mode (3/3)... 16 Volume-dose/Time (V/T) mode... 17 Vigilant Drug’Lib mode (1/2) ... 18 Vigilant Drug’Lib mode (2/2) ... 19 Manual bolus ... 20 Programmed bolus (1/2) ... 20 Programmed bolus (2/2) ... 21 Volume Limit (VL) mode ... 22 History... 23 5. DISPLAY AND SYMBOLS... 25 6. ALARM AND SAFETY FEATURES ... 28 7. MENU ... 30 Permanent menu ... 30 Menu selected in option mode... 31 8. OPTIONS... 32 9. USER TEST... 35 10. PERFORMANCES ... 36 Rates range ... 36 Dose range ... 36 Volume Limit ... 36 Volume-dose/Time range ... 36 Dilution range... 37 Patient data ... 37 Drug library ... 37 Syringe list ... 37 Accuracy ... 38 Programmable pause ... 38 Pressure management ... 38 Occlusion alarm response time and Bolus volume at occlusion release ... 39 Units and conversion rules ... 40 2

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11. TECHNICAL CHARACTERISTICS... 41 Electrical power ... 41 Battery ... 41 Communication port... 41 Infrared communication ... 41 Compliance... 41 Dimensions - Weight... 42 Trumpet curves... 42 12. GUIDANCE AND MANUFACTURER’S DECLARATION ON EMC ... 43 Electromagnetic emissions - Table 201... 43 Electromagnetic immunity - Table 202 ... 43 Electromagnetic immunity - Table 204 ... 44 Recommended separation distances between portable and mobile RF communication equipment and Injectomat® MC Agilia - Table 206 ... 45 13. CLEANING AND USE CONDITIONS ... 46 Cleaning and disinfecting... 46 Environmental conditions... 46 Use of the internal battery... 46 Recommendations... 47 14. SERVICES... 48 Conditions of guarantee... 48 Quality control... 48 Preventive maintenance ... 48 Servicing ... 48 Data racks, accessories and maintenance tools ... 49

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1. Introduction Injectomat® MC Agilia is a syringe pump with dose rate functions. Very intuitive, its training is fast as for the rest of the Agilia products. The "Push-guard" protection, the infusion and pressure monitoring, the didactical messages and symbols minimize the risks during an infusion. Thanks to its several securities and to the Vigilant® Drug’Lib mode, Injectomat® MC Agilia is particularly suitable for specialty wards and basic ICUs.

Programming modes

Injectomat® MC Agilia can be programmed in three different modes. Mode

Description

No drug name

All infusion parameters must be defined. The drug name is not selected. In dose rate mode, the dilution units and values, the patient’s weight, the flow rate units and values must be defined. The drug can be infused in flow rate (ml/h), dose rate, Volume-dose/Time (V/T) or Volume/Limit (VL).

Drug labelling

The drug name is selected during the infusion programming and displayed on the screen during infusion. This mode works as the No drug name mode. The drug list can be modified through the Vigilant® Drug’Lib software which allows you to download, modify and reload the drug list.

Vigilant® Drug’Lib

This mode is the safest of all modes. The drug parameters are defined in the drug library: authorised dilution units and value ranges, default flow rate units and values, authorised infusion modes (ml/h, dose rate, V/T), authorised boluses and bolus parameters, authorised loading dose and loading dose parameters, flow rate maximum and soft limit values, etc. The drug library should be created through the Vigilant® Drug’Lib software which allows you to download, modify and reload the drug library.

Note: In Drug labelling and Vigilant® Drug’Lib modes, you can select "Drug X (ml/h)" or "Drug X (dose rate)" to define all parameters for an unspecified drug (not in the drug list, nor in the drug library) without changing the programming mode.

Infusion modes The following infusion modes are authorised. Mode

Description

Flow rate (ml/h)

Drug infusion in ml/h.

Dose rate

Drug infusion with dilution, patient’s weight and flow rate per kg (if selected).

Volume-dose/Time (V/T) Drug infusion with a volume or a dose and time. Volume Limit (VL)

Drug infusion with volume and/or dose limit.

Injectomat® MC Agilia also allows you to infuse manual or programmed boluses and loading doses.

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ml/h No drug name

Dose rate

Drug infusion with all parameters defined by user

Volume-dose/Time Volume Limit ml/h

Drug labelling Drug name selected from drug list. All parameters defined by user.

Dose rate Volume-dose/Time Volume Limit

ml/h Vigilant Drug‘Lib

Dose rate Volume-dose/Time

Safest mode. All parameters defined in drug library.

Volume Limit

Drug X (dose rate) Drug X (ml/h)

Intended use  Injectomat® MC Agilia is a syringe pump made for intravenous (IV) drug infusion. It must only be used by professionals working in hospitals.

Precautions to be taken  The symbol visible on the device, recommends this operator’s guide should be completely read.  Injectomat® MC 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 (Electroencephalogram), ECG (Electrocardiogram), etc. If Injectomat® MC Agilia is placed near devices like surgical equipment HF, X-rays, NMR (Nuclear Magnetic Resonance), mobile phones or Wifi points, minimal distances between equipment are essential (see page 44).  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. 2857-4_nu_injectomat_MC_agilia_INT

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2. Description

1

2

3

4

5 6

7

10

11

6

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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12

13

14

15

16

26

25

20 24

23

22

19

18

17

21

12 -

Mains warning

17 -

Correction / Back

13 -

Screen

18 -

STOP infusion

14 -

SILENCE ALARM

19 -

Validation

24 -

15 -

Graphic

20 -

BOLUS or PRIME

Menu

Functioning, pre-alarm and alarm warnings

25 -

16 -

26 -

ON / OFF

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21 to

Value selection

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3. Installation Three different ways

On a table

Two devices maximum can be assembled during infusion.

On a pole

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

On a rail

When the devices are assembled, the assembly bolts must be in closed position

Three devices on a pole: at least two 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  Fold the fixing clamp against the pump. device from the pole. Push the fixing button (B).

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.

 Move the pusher forward to the syringe head.

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

 Check the general installation.

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4. Operations General operations These operations can be repeated and/or modified during the infusion process. To start-up the device, see page 13. Note: For information on leds, see Indicator lights in chapter Display and symbols, page 25.

Prime (purge)

Pause

 Connect the extension set 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 1: You can set the prime as mandatory or advised with the Ward option [Par 7] (see page 34). Note 2: During priming, the occlusion pressure level is set to its maximum value (900 mmHg).

 To stop the infusion, press the <STOP> key.  To start the infusion, press start.  To program a pause, press the <STOP> key twice, then select the pause duration. The pause can also be programmed from the menu.  When the pause duration is over, press start to continue with the infusion.  If desired, press the checkbox button to activate the " Start infusion at pause end " option for an automatic start.

Silence alarm  Press the <SILENCE ALARM> key to silence the audible signal. Preventive silence: to change a syringe without any audible signal, stop infusion by pressing the <STOP> key. Press the <SILENCE ALARM> key and change the syringe.

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Pre-Programming the infusion The Injectomat® MC Agilia can be pre-programmed before loading the syringe. The syringe holder is in a closed position (syringe not loaded). Infusion adjustments can be made as described in the Operations chapter.

 Switch on the device and select the prog button.

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 Configure the infusion: select the drug and dilution.  Enter the patient data.  Select the flow rate.  Press OK to validate the infusion.  Press exit to validate the program parameters.  Install the syringe.  Press OK to confirm the syringe, and Start to launch the infusion.

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No drug name and Drug labelling modes 1 - Start-up

2 - Drug mode

 Check that the Injectomat® MC Agilia is not damaged.  Connect the power supply cord to the mains source and to the syringe pump: the mains warning lights up. Caution: For a first start-up, go to page 46.  Press the <ON> key to turn the pump ON.  Press C to change the drug mode or press OK.

 Use the arrows to select a drug mode: No drug name or Drug labelling. (For Vigilant DrugLib, go to page 18) Note: Drug labelling is available only if preselected in the Ward option [Par 22] (see page 34).  Press OK.

3 - Infusion mode

4 - Syringe selection

 Select the infusion mode: Flow rate (ml/h) or Dose rate.  Press OK.

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

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5 - Drug selection (only with Drug labelling mode)

Note: If you select Drug labelling, a screen displays information about the preselected drug library. Press OK to display the Drug list.  Use the arrows to select a name in the Drug list and press OK. Note: Select "Drug X (ml/h)" or "Drug X (dose rate)" if you want to define a flow rate or a dose rate infusion from the predefined Drug list.

Flow rate mode...

or Dose rate mode (1/3)

6 - Flow rate / Start

6 - Dilution units

 Use the arrows to select the dilution units.  Select the flow rate with the selection keys. Note: You can select "unit/ml" or "unit/Xml". For the Note: Check the infusion parameters (syringe, flow list of units, see page 40. These units are preselected rate, etc.). in the Ward option [Par 20] (see page 34).  To start the infusion, press start.  Press OK to confirm your choice.  The flow rate can be modified during infusion. Note: During the infusion, you can check the infused volume by pressing the <MENU> key. The infusion screen returns automatically or press the <MENU> key again

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Dose rate mode (2/3) 7 - Dilution values

8 - Flow rate units

 Select the dilution values.  Press OK to confirm your choice.

 Use the arrows to select the flow rate units.  Press OK to confirm your choice

9 - Weight

10 - Flow rate selection

Note: This screen only appears if you have. selected a flow rate unit of "mg/kg/h" type. The default weight is set in the Ward option [Par 23] (see page 34).  Select a value.  Press OK to confirm your choice.

 Select the flow rate value.  Press OK to confirm your choice.  The flow rate can be modified during infusion.

(only with Drug labelling mode)

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Dose rate mode (3/3) 11 - Loading dose question

12 - Loading dose settings

 Answer the question: "Do you want a loading dose?" - If you press no, return to step 10 and press start. - If you press yes, go to step 12.

 Set up the loading dose parameters and press OK.

Note: The loading dose option should be activated first in the Ward option [Par 19] (see page 34).

13 - Loading dose start

14 - Loading dose interruption

 Press C to change the loading dose parameters.  Press start to start the loading dose.

 Press the <STOP> key to interrupt the loading dose. Note: If you press the <STOP> key twice, the loading dose is deleted. Press start to continue with the infusion.  Answer the question: "Continue?" - If you press no, the loading dose is deleted. Press start to continue with the infusion. - If you press start, the loading dose is confirmed and the infusion continues at the end of the loading dose. Note: During the infusion, you can check the infused volume by pressing the <MENU> key. The infusion screen returns automatically or you can press the <MENU> key again.

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Volume-dose/Time (V/T) mode 1 - Mode selection

2 - Volume-dose/Time selection

 Follow the same steps as if you were programming a dose rate or a flow rate infusion.  Before selecting an infusion value, press the <MENU> key and select the "Volume/Time" option.  Press enter to set the parameters.

 Select the volume (or dose) and the time.  Select the end of infusion: stop, KVO, or continuous infusion mode.  Press OK. Note: KVO means Keep Vein Open.

3 - Volume-dose/Time start

4 - Shut-down

 Press start to start the infusion. Note 1: Check the infusion process with the VTI (Volume To Infuse) or DTI (Dose To Infuse) value. Note 2: When the pump reaches the Volume/Time, a pre-alarm and an alarm beep (see page 28).

 Press the <STOP> key to interrupt the infusion.  Press the <OFF> key continuously, until the current screen disappears.

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Vigilant Drug’Lib mode (1/2)

The Vigilant® Drug’Lib mode is the safest and simpliest way to administrate a drug via the Injectomat® MC Agilia. You simply need to select a drug from a drug library in which drugs have been predefined with all their infusion parameters (To define drug libraries, see Vigilant® Drug’Lib for Agilia user guide).

1 - Mode selection

2 - Drug selection

 Start-up the pump.  In the Modes screen, select "Vigilant DrugLib" and press OK.  In the Syringe screen, select the syringe type and press OK. Note: The Vigilant Drug'Lib mode is available if preselected in the Ward option [Par 22] (see page 34).

 In the Drug library, select the drug to be infused and press OK. Note: The Drug library is preselected in the Ward option [Par 17] (see page 34).

3 - Drug information

4 - Dilution selection

To add your comments with Vigilant Drug ’Lib

 Check the information concerning the drug and press OK.

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 In the Dilution screen, use the arrows to select a value and press OK. Note 1: Depending on the predefined drug parameters, this screen might be optional or followed by the Vol-dose/time screen.

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Vigilant Drug’Lib mode (2/2) 5 - Weight selection

6 - Flow rate selection

 In the Weight screen, select a value and press OK. Note: Depending on the predefined drug parameters, this screen might be optional.

 Select a dose rate value and press start to start the infusion.

7 - Infusion in progress

8 - Shut-down

 The lighthouse animation in the upper-left corner of the screen indicates that the infusion is in progress. Note 1: Press the <STOP> key to interrupt the infusion, or the <MENU> key to know the infused volume or dose. Note 2: A warning message may appear if the flow rate exceeds a predefined upper or lower soft limit. You can either press start and authorize the soft limit overflow, or modify or stop the infusion.

 Press the <STOP> key to interrupt the infusion.  Press the <OFF> key continuously, until the current screen disappears.

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Manual bolus Manual bolus

 Follow the same steps as if you were programming a dose rate or a flow rate infusion.  Select the infusion value.  Press the <BOLUS> key twice: one short press (displays bolus rate), then one continuous press (activates bolus  check dose on screen).  Release the <BOLUS> key to stop the manual bolus. Note 1: To define a bolus rate, press the <BOLUS> key until the bolus rate flashes, then select the bolus rate (ml/h) and press OK. Note 2: During bolus, the occlusion pressure level is set to its maximum value (900 mmHg).

Programmed bolus (1/2) 1 - Via <BOLUS> key

1 - Via <MENU> key

 Press the <BOLUS> key.  Press prog. The "Programmed bolus" screen appears. Go to step 2.

 Follow the same steps as if you were programming a dose rate or a flow rate infusion.  Press the <MENU> key.  Select "Programmed bolus" in the menu.  Press enter. Note: This function is accessible during infusion and just before infusion launch (flow rate selection screen).

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