Injectomat TIVA Agilia Instructions for Use

Contents 1. INTRODUCTION ... 4 About pharmacokinetic models... 4 Pharmacokinetic models in the Injectomat® TIVA Agilia... 5 Programming modes ... 8 Infusion modes ... 9 Intended use ... 10 Precautions to be taken ... 10 2. DESCRIPTION ... 11 3. INSTALLATION ... 13 4. OPERATIONS ... 16 General operations ... 16 No drug name and Drug labelling modes ... 18 Flow rate mode... ... 19 or Dose rate mode (1/3)... 19 Dose rate mode (2/3)... 20 Dose rate mode (3/3)... 21 Volume-dose/Time (V/T) or (D/T) modes ... 22 TIVA mode (1/2) ... 23 TIVA mode (2/2) ... 24 Manual bolus ... 25 Programmed bolus (1/2) ... 25 Programmed bolus (2/2) ... 26 Volume Limit (VL) mode ... 27 TCI mode ... 28 History... 35 5. DISPLAY AND SYMBOLS... 38 6. ALARM AND SAFETY FEATURES ... 41 7. MENU ... 44 Permanent menu ... 44 Menu selected in option mode... 45 8. OPTIONS... 47 9. USER TEST... 51 10. PERFORMANCES ... 52 Rates range ... 52 Dose range ... 52 Volume Limit ... 52 Volume-dose/Time range ... 52 Induction duration range ... 53 Dilution range... 53 Patient data... 53 Syringe list ... 53 Drug library ... 54

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Accuracy ... 54 Programmable pause ... 54 Pressure management ... 55 Occlusion alarm response time and Bolus volume at occlusion release ... 56 Units and conversion rules ... 57 11. TECHNICAL CHARACTERISTICS... 58 Electrical power ... 58 Battery ... 58 Communication port... 58 Infrared communication ... 58 Compliance... 58 Dimensions - Weight... 59 Trumpet curves... 59 12. GUIDANCE AND MANUFACTURER’S DECLARATION ON EMC ... 60 Electromagnetic emissions - Table 201... 60 Electromagnetic immunity - Table 202 ... 61 Electromagnetic immunity - Table 204 ... 62 Recommended separation distances between portable and mobile RF communication equipment and Injectomat® TIVA Agilia - Table 206... 63 13. CLEANING AND USE CONDITIONS ... 64 Cleaning and disinfecting... 64 Environmental conditions... 64 Use of the internal battery... 64 Recommendations... 65 14. SERVICES... 66 Conditions of guarantee... 66 Quality control... 66 Preventive maintenance ... 66 Servicing ... 66 Maintenance requirements ... 67 Data racks, accessories and maintenance tools ... 67

Valid for software version 4.3.

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1. Introduction Injectomat® TIVA Agilia focuses on anaesthesia requirements. The device can be used to administer IV anaesthetic drugs in TCI mode (Target Controlled Infusion) and other IV drugs following standard infusion profiles, i.e continuous flow rate, bolus and induction dose. This device is an open system. It combines ease of use and the most complete set of features, including Pharmacokinetic (PK) models. The drug libraries can be adjusted with the Vigilant® Drug'Lib.

About pharmacokinetic models The device is designed to infuse anaesthetic drugs in target controlled mode. In such a mode, the infusion pump follows a flow rate profile to rapidly achieve the concentration target you set and to maintain it. The flow rate profile follows a pharmacokinetic model. The pharmacokinetic models included in the Injectomat® TIVA Agilia have been established and previously validated by clinical studies. The goal of these clinical studies was to estimate the accuracy of each model. A clinical review was performed to select the pharmacokinetic models that best fit the clinical practices. As a pharmacokinetic model is a mathematical representation of the drug distribution and elimination, it is an approximation of reality. The error of a model can be computed by the following formula: PE =100 x (Cm-Cp)/Cp, where Cm is the measured concentration and Cp the predicted concentration. From this value, the MADPE is computed. This is the mean value of the absolute value of the PE. Pharmacokinetic models that are included in the Injectomat® TIVA Agilia have been shown to have an MADPE < 30%. All pharmacokinetic models included in the Injectomat® TIVA Agilia are 3-compartment models that can be represented as follows:

Infusion Flow k21 V2

k13 V1

k12

V3 k31

k10 where:  V1 is the central compartment (mainly the blood),  V2 and V3 are respectively the fast and slow distribution volumes,  kij represents the partition coefficients that determine the speed at which the drug goes from one compartment to another.  K10 is the elimination of the drug by the body. In such a model, the plasmatic concentration is equal to the concentration of the drug in the central compartment. The effect site concentration is the estimation of the concentration in a 4th compartment that represents the organ where the drug is active. This compartment is virtually linked to the central compartment with a partition coefficient named ke0. This compartment has no physical volume. The effect site concentration and the plasmatic concentration equilibrate after a period of time, depending on the ke0 value. This value depends on the drugs and was established by clinical studies that compared the plasmatic level (after equilibration) and the effect measured (mainly with an EEG response). 4

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Pharmacokinetic models in the Injectomat® TIVA Agilia

The pharmacokinetic models included in the Injectomat® TIVA Agilia were not developed specifically for the device but they were established and validated by numerous clinical studies. For more information on the pharmacokinetic parameters, please refer to the clinical document. Propofol Marsh 1991 Ref. 1 Vc (L)

K10 (min-1) K12 (min-1)

Remifentanil Minto et al. 1997 Ref. 4

Sufentanil Gepts et al. 1995 Ref. 5

Alfentanil Scott et al. 1987 Kapilla et al. 1995 Ref. 6/7 *

5.1-0.0201 (Age - 40) + 0.072 (LBM - 55) [2.6 - 0.0162 x (Age - 40) + 0.0191 x (LBM - 55)] / Vc

14.3 0.0645

2.19 0.0894

Propofol Schnider et al. 1998, 1999 Ref. 2/3

0.228 x Weight 4.27 0.119 [1.89 + 0.0456 x (Weight - 77) 0.0681x(LBM - 59) + 0.0264 x (Height - 177)] / Vc 0.112 0.302 - 0.0056 (Age - 53)

[2.05 - 0.0301 x (Age - 40)] / Vc

0.1086

0.6540

K13 (min-1)

0.0419

0.196

[0.076 - 0.00113 x (Age - 40)] / Vc

0.0229

0.2090

K21 (min-1)

0.055

0.1180

K31 (min )

0.0033

[2.05 - 0.0301 x (Age - 40)] / [9.82 - 0.0811 x (Age - 40) + 0.108 x (LBM - 55)] [0.076 - 0.00113 x (Age - 40)] / 5.42

0.0245

-1

[1.29 - 0.024 (Age - 53)] / [18.9 - 0.391 (Age - 53)] 0.0035

0.0013

0.0177

Ke0 (min-1)

1.21

0.456

0.595 - 0.007 x (Age - 40)

0.112

0.77

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LBM: for male 1.1xWeight-128(Weight/height) for female: 1.07xWeight-148(Weight/height) BMI: Weight/Height 2 ; Weight in kg; Height in m. * Alfentanil phamacokinetic model is available in option only.

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Weight in kg; Height in cm; Age in years.

Note: Special attention should be paid when using the Marsh and Schnider models for the propofol. These two models lead to different flow rate profiles and the proper concentration can be different regarding the chosen model. Bibliographical references about the pharmacokinetic models 1. Marsh - White - Morton - Kenny. Pharmacokinetic model driven infusion of propofol in children. British Journal of Anesthesia 1991; 67: 41-48. 2. Schnider - Minto - Shafer - Gambus - Andresen - Goodale - Youngs. The influence of age on propofol pharmacodynamics. Anesthesiology 1999; 90: 1502 - 1516. 3. Schnider - Minto - Gambus - Andresen - Goodale - Shafer - Youngs. The influence of method of administration and covariates on the pharmacokinetics of propofol in adult volunteers. Anesthesiology 1998 ; 88 : 1170 - 1182. 4. Minto - Schnider - Egan - Youngs - Lemmens - Gambus - Billard - Hoke - Moore - Hermann - Muir - Mandema - Shafer. Influence of age and gender on the pharmacokinetics and pharmacodynamics of remifentanyl. Anesthesiology 1997; 86: 10 - 23. 5. Gepts, Shafer, Camu, Stanski, Woestenborghs, Van Peer, Heykants. Linearity of pharmacokinetics and model estimation of sufentanil. Anesthesiology 1995; 83: 1194-1204. 6. Scott J, Ponganis K, Stanski D. EEG Quantitation of narcotic effect: the comparative pharmacodynamics of fentanyl and alfentanil. anesthesiology 1985; 62: 234-241. 7. James C Scott and Donald R. Stanski «Decrease Fentanyl and Alfentanil dose requirements with age. A simultaneous pharmocokinetic and pharmacodynnamic evaluation» - The Journal of Pharmocology And Experimental Therapeutics 1987; N 53855/1 Vol.240 n°1

Control of the effect site concentration The Injectomat® TIVA Agilia allows the effect site concentration to be controlled. This control is different from plasmatic concentration control as it permits an overshoot on the plasmatic concentration to rapidly achieve the effect site concentration. Before using the effect site concentration mode, you must evaluate if such an overshoot matches the patient status. For fragile patients (ASA 3 or 4) or elderly patients, the use of the effect site control has to be done carefully.

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Populations When using TCI mode, it is always better to titrate the concentration. This means that the proper concentration for your patient can be found by progressively increasing the target until the desired effect is reached. The TCI modes can be used for adult patients from 15 to 100 years old. Particular attention must be paid to the Marsh model as this model does not take age into account. For patients older than 55 the Schnider model has proven to be more accurate. The TCI modes can be used with patients from 30 to 200 kg, for morbidly obese patients the accuracy of the pharmacokinetic models has not been validated and the TCI modes should be used carefully. In addition, the Schnider and Minto models, as being LBM (Lean Body Mass) dependant, cannot be selected when the patient parameters lead to a calculated BMI (Body Mass Index) higher than 42 for male and 35 for female patients. As the pharmacokinetic models were determined statistically it is always recommended, before starting the infusion, to control the flow rate profile and to check whether this profile corresponds to the one you would administer in a non-TCI mode.

Flow rate profile control Plasmatic mode

Effect site concentration mode

In TCI plasma mode, the flow rate profile

In TCI effect, the flow rate profile

is as follows:

is as follows:

Flow rate (max)

Flow rate (max)

Flow rate (min)

Flow rate (min) Stop  Bolus dose

 Bolus dose Plasmatic concentration target

Plasmatic concentration

Plasmatic concentration

Effect site concentration target

Flow rate

Effect site concentration Flow rate

During target set up, the Injectomat® TIVA Agilia always displays the flow rate profile that will be infused. This profile corresponds to the bolus dose and the minimum and maximum flow rates to achieve the target. In some cases, one of these values may be outside the recommended prescriptions of the drug. You can then decide to reduce the target or to accept the flow rate profile by validating the target.

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Recommended drug dilutions In TCI mode, the flow rate is automatically adjusted to achieve and maintain the concentration target. To ensure the best accuracy, the flow rate must be greater than 1 ml/h. This flow rate depends on the drug dilution, the target value and the duration of the infusion (when the equilibrium is reached, the flow rate is close to the clearance of the drug). As for standard infusion, the more the drug is diluted, the higher the flow rate. To allow the setting of low concentration targets, we recommend adapting the dilution. The drug library contains the following dilution range:  Propofol: 1 % and 2 %,  Remifentanil: 5 to 50 µg/ml,  Sufentanil: 0.05 to 5 µg/ml,  Alfentanil: 50 to 500 µg/ml. These values can be changed according to your own practice, using the Vigilant® Drug’ Lib software.

Default configuration The drugs that can be delivered in TCI are defined in the drug library. The default drug library was defined to allow the administration of Propofol, Sufentanil and Remifentanil in TCI. Note: Alfentanil phamacokinetic model is available in option only. Drugs available in TCI

Propofol - Remifentanil - Sufentanil - Alfentanil

Pharmacokinetic models

Propofol: Marsh/Schnider Sufentanil: Gepts Remifentanil: Minto Alfentanil: Scott

Range of concentrations

Propofol: 0-15 µg/ml Sufentanil: 0-3 ng/ml Remifentanil: 0-20 ng/ml Alfentanil: 0-500 ng/ml

Range of dilutions

Propofol: 1 % (10 mg/ml) and 2 % (20 mg/ml) Sufentanil: 5 µg/ml max. Remifentanil: 50 µg/ml max. Alfentanil: 500 µg/ml max.

TCI mode

Plasmatic control Effect site control

Accuracy (% of errors on the calculated concentration from delivered volume)

± 3 % with a minimum of ± 0.1 ml

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Precautions to be taken in TCI mode  The pharmacokinetical models of a drug have been established for patients without any previous administration of this drug. Before infusing in TCI mode, make sure the patient did not receive any medication with the envisaged drug.  If, during TCI mode use, the infusion device is switched off, the pharmacokinetic log is reset to zero. If the device is switched on again and the same patient infused, the previous current dose is not taken into account. It is then recommended to resume the infusion in TIVA mode.  When administrating an induction dose of short half-life drug at low flow-rate, the actual start-up delivered volume may be different from the model information displayed. To ensure best accuracy, it is consequently recommended to use small capacity syringes and/or dilute the drugs.  The default values result from experts' assessments in medical publications. They are given as a guide and must be carefully checked before use to comply with your specific clinical application.  All other drugs can be administered in continuous mode in ml/h or by setting the dose rate programmed in TIVA mode.  When using the Injectomat® TIVA Agilia to administer anaesthetic drugs in TCI, it is always recommended to titrate the concentration by progressively increasing the target concentration until the appropriate effect is achieved. It is also recommended to always check the flow rate profile that will be delivered and to validate this profile. For each target change, the Injectomat® TIVA Agilia displays the value of the bolus, the minimum and maximum flow rate that will be infused to the patient. As the pharmacokinetic models were determined statistically, you must evaluate if this flow rate profile corresponds to the one you would administer in a non-TCI mode.

Programming modes

Injectomat® TIVA Agilia can be programmed in four different modes. The mode change should be made before the infusion starts. 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. The drug list can be modified through the Vigilant® Drug’Lib software which allows the drug list to be downloaded, modified and reloaded.

TIVA

The drug parameters are defined in the drug library: authorized dilution units and value ranges, default flow rate units and values, authorised infusion modes (ml/h, dose rate, V/T), authorized boluses and bolus parameters, authorized induction dose and induction dose parameters, flow rate maximum and soft limit values, etc. The drug library should be created and downloaded with our Vigilant® Drug ‘Lib software.

TCI

The TCI mode is dedicated to anaesthesia. It includes PK models.The drug library can be adjusted thanks to Vigilant® Drug'Lib for Agilia. In TCI, it allows to adjust the initial list of drugs combined with their dilution, model and target site (plasma or effect).The TCI can run either in plasmatic mode or effect mode.

Note: In Drug labelling and TIVA 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.

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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® TIVA Agilia also allows you to infuse manual or programmed boluses and induction doses.

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 TIVA All parameters defined in library

Dose rate Volume-dose/Time Volume Limit

TCI All parameters defined in library

Pharmacokinetics models

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

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Intended use

 Injectomat® TIVA Agilia is designed to infuse anaesthetic drugs in target controlled mode. In such a mode, the infusion pump follows a flow rate profile to rapidly achieve the concentration target set and maintain it. It must only be used by trained professionals working in hospitals and/or in road ambulances (associated to mandatory accessory Agilia Holder Ambulance).

Precautions to be taken  The symbol

visible on the device, indicates that this document should be completely read.

 Injectomat® TIVA 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 undesirable interference with other equipments such EEG, ECG, etc. If Injectomat® TIVA Agilia is placed near devices such as surgical equipment HF, X-rays, mobile phones or Wifi points, minimal distances between the devices are essential (see page 62).  Use in a Magnetic Resonance Imaging unit: the pump may be operated safely with the MRI Guard Agilia device only in order to prevent electromagnetic interferences. Please refer to its specific Instructions For Use.  Due to use into road ambulances, performances of Agilia IV pump can be modified. Medical staff must remain nearby the Agilia IV pump to react in an appropriate way. Please refer to Agilia Holder Ambulance Instructions For Use.  The Injectomat® TIVA Agilia 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 must be used in an anaesthesia environment with all the necessary equipment to ensure patient safety, such as vital sign monitors and ventilators.  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 pump must not be used to administer non-water soluble solutions or unsterile fluids.  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.  Before starting infusion, take care of any possible interactions with other anaesthetic drugs.  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

1

2

4

3

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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11

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

12

21 to

Value selection

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3. Installation Three different positions

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. When installed on rolling stand, do not tip over the system more than 5°: it may fall.

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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

 Place the syringe in its cradle, the flanges

 Move the pusher forward to the syringe head.

 Check the general installation.

according to proper practices. Check that there is no air bubble left in the syringe.

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correctly inserted in the provided slot . Secure the syringe with the syringe barrel clasp.

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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 18. Note: For information on the LEDs, see Indicator lights in the Display and symbols chapter, page 38.

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 49). 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 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® TIVA 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  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® TIVA 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 64.  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 50).  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 TIVA, go to page 23) Note: Drug labelling is available only if preselected in the Ward option [Par 22] (see page 50).  Press OK.

3 - Infusion mode

4 - Syringe selection

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

Note: The syringe installed must correspond to the syringe displayed.  Press OK to confirm the 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 57. These units are preselected rate, etc.) in the Ward option [Par 20] (see page 50).  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 50).  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 by pushing the arrow keys.

(only with Drug labelling mode)

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