Injectomat MC Agilia Instructions for Use

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 ... 12 Flow rate mode or Dose rate mode (1/3)... 13 Dose rate mode (2/3)... 14 Dose rate mode (3/3)... 15 Volume-dose/Time (V/T) mode... 16 Vigilant Drug’Lib mode (1/2) ... 17 Vigilant Drug’Lib mode (2/2) ... 18 Manual bolus ... 19 Programmed bolus (1/2) ... 19 Programmed bolus (2/2) ... 20 Volume Limit (VL) mode ... 21 5. DISPLAY AND SYMBOLS... 22 6. ALARM AND SAFETY FEATURES ... 25 7. MENU ... 27 Permanent menu ... 27 Menu selected in option mode... 28 8. OPTION ... 29 9. USER TEST... 32 10. PERFORMANCES ... 33 Rates range ... 33 Dose range ... 33 Volume Limit ... 33 Volume-dose/Time... 33 Syringe list ... 34 Drug library ... 34 Accuracy ... 35 Programmable pause ... 35 Pressure management ... 35 Occlusion alarm response time ... 36 Bolus volume at occlusion release ... 36 Units and conversion rules ... 36

2

2857-1_nu_injectomat_mc_agilia_int

11. TECHNICAL CHARACTERISTICS... 37 Electrical powers... 37 Battery ... 37 8-pin connector ... 37 Infrared communication ... 37 Compliance... 37 Dimensions - Weight... 38 Trumpet curves... 38 12. GUIDANCE AND MANUFACTURER’S DECLARATION ON EMC ... 39 Electromagnetic emissions - Table 201... 39 Electromagnetic immunity - Table 202 ... 39 Electromagnetic immunity - Table 204 ... 40 Recommended separation distances between portable and mobile RF communication equipment and Injectomat® MC Agilia - Table 206 ... 41 13. CLEANING AND USE CONDITIONS ... 42 Cleaning and disinfecting... 42 Environmental conditions... 42 Use of the internal battery... 42 Recommendations... 43 14. SERVICES... 44 Conditions of guarantee... 44 Quality control... 44 Preventive maintenance ... 44 Servicing ... 44 Data racks, accessories and maintenance tools ... 45 Catheter extension sets ... 46

2857-1_nu_injectomat_mc_agilia_int

3

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 coming with a drug library, 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 is saved by default in the device. The drug parameters can be modified 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.

4

2857-1_nu_injectomat_mc_agilia_int

m l/h

N o d ru g n a m e

D o s e r a te

D ru g in fu s io n w ith a ll p a ra m e te rs d e f in e d b y u s e r

V o lu m e -d o s e /T im e V o lu m e L im it m l/h

D r u g la b e llin g D ru g n a m e s e le c te d fro m d r u g lis t. A ll p a r a m e te rs d e f in e d b y u s e r .

D o s e r a te V o lu m e -d o s e /T im e V o lu m e L im it

m l/h

V ig ila n t D r u g ‘L ib D o s e r a te V o lu m e -d o s e /T im e

S a fe s t m o d e . A ll p a r a m e te rs d e f in e d in d ru g lib ra ry .

V o lu m e L im it

D ru g X (d o s e ra te ) D ru g X (m l/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, ECG, etc. If Injectomat® MC Agilia is placed near devices like surgical equipment HF, X-rays, NMR, mobile phones or Wifi points, minimal distances between equipment are essential (see page 40). 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.

2857-1_nu_injectomat_mc_agilia_int

5

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 11-30 Vdc power

2857-1_nu_injectomat_mc_agilia_int

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

2857-1_nu_injectomat_mc_agilia_int

21 to

Value selection

7

3. Installation

Three different ways

On a table

Two devices maximum can be assembled together 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.

8

2857-1_nu_injectomat_mc_agilia_int

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

2857-1_nu_injectomat_mc_agilia_int

B

9

Installing a syringe

10

Connect the extension set to the syringe according to proper practices.

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.

2857-1_nu_injectomat_mc_agilia_int

4. Operations

General operations These operations can be repeated and/or modified during the infusion process. To start-up the device, see page 12. Note: For information on leds, see Indicator lights in chapter Display and symbols, page 22.

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 continuously (activates prime check dose on screen). To stop the prime, release the <PRIME> key. Connect the patient. Note: You can set the prime as mandatory or advised with the Ward option [Par 7] (see page 31).

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.

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.

2857-1_nu_injectomat_mc_agilia_int

11

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 42. Press the <ON> key to turn the pump ON. Note: The Modes screen appears only if preselected in the Ward option [Par 21] (see page 31). 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 17) Note: Drug labelling is available only if preselected in the Ward option [Par 22] (see page 31). 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.

12

2857-1_nu_injectomat_mc_agilia_int

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 list Note: Check the infusion parameters (syringe, flow of units, see page 36. These units are preselected in rate, etc.). the Ward option [Par 20] (see page 31). To start the infusion, press start. Press OK to confirm your choice. 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

2857-1_nu_injectomat_mc_agilia_int

13

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

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

9 - Weight (only with Drug labelling mode)

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 31). Select a value. Press OK to confirm your choice.

14

8 - Flow rate units

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

10 - Flow rate selection

Select the flow rate value. Press OK to confirm your choice.

2857-1_nu_injectomat_mc_agilia_int

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.

13 - Loading dose start

14 - Loading dose interruption

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

2857-1_nu_injectomat_mc_agilia_int

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. 15

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 Time Infused) or DTI (Dose Time Infused) value. Note 2: When the pump reaches the Volume/Time, a pre-alarm and an alarm beep (see page 25).

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

16

2857-1_nu_injectomat_mc_agilia_int

Vigilant Drug’Lib mode (1/2) The Vigilant® Drug’Lib mode is the most 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). The Injectomat® MC Agilia can support 50 drugs which can be divided in 4 libraries (one is predefined).

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 31).

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 31).

3 - Drug information

4 - Dilution selection

To add your comments with Vigilant Drug ’Lib

Check the information concerning the drug and press OK.

2857-1_nu_injectomat_mc_agilia_int

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.

17

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 then press start and authorize the soft limit overflow, modify or stop the infusion.

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

18

2857-1_nu_injectomat_mc_agilia_int

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 check dose on screen). (activates bolus Release the <BOLUS> key to stop the manual bolus. Note: To define a bolus rate, press the <BOLUS> key until the bolus rate flashes, then select the bolus rate (ml/h) and press OK.

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.

2857-1_nu_injectomat_mc_agilia_int

19

Programmed bolus (2/2) 2 - Bolus setting

Set up the bolus parameters.

3 - Bolus start

Press C to modify the bolus values. Press start to start the bolus. Note: If you press the <BOLUS> key again, this screen appears directly with the last bolus parameters.

4 - Bolus interruption

5 - Shut-down

Press the <STOP> key to interrupt the bolus. Answer the question: “Continue?” - If you press no, the bolus is deleted. - If you press start, the bolus goes on

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

20

2857-1_nu_injectomat_mc_agilia_int