Fresenius Pilote A2 User manual

O P E R A T O R ’ S G U I D E

Syringe pump

3,/27 $

Introduction

The Pilot A2 has been designed and manufactured with the greatest care. It introduces a new concept of control with easy reading of alarms and safety features.

The configuration flexibility of the Pilot A2 provides overall improvement in the working conditions of medical teams, thus increasing patient safety. A choice of easily accessible configurations ensures optimum use of functions according to the needs of each department.

The use of this material requires great care. The user must be able to handle the instrument properly and must know how to fully operate.

Please read the operator’s guide carefully before putting the device into use.

Table of contents
Operations for use ......................................................	2
Internal safety features ...............................................	3
Performances...............................................................	5
Technical characteristics ...........................................	6
Configuration ...............................................................	8
Operating precautions ................................................	9
Maintenance...............................................................	10
External power source ..............................................	12
Operation with the internal battery..........................	12
Accessories................................................................	13
Disposable .................................................................	13
Conditions of guarantee ...........................................	14
Useful addresses.......................................................	16

Operations for use

Installation

The syringe pump can be used on mains , battery or external supply.

Particular attention should be paid to the stability of the device before it is put into use.

1.Connect the power supply cord to the mains source and to the syringe pump. The mains power indicator lights up .

Note: connect device to mains as often as possible to recharge battery.

Syringe installation

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

2.Place syringe in its cradle, the flanges correctly in the provided slot.

3.Turn the syringe barrel clasp into the closed position and move the syringe drive forward the syringe plunger head.

Syringe barrel clasp

Í Syringe flanges cradle

Syringe plunger head

4. Press the ON key to turn ON the Pilot.

Note: if &WU/ is displayed, preventive maintenance should be considered. Press to continue.

Programming infusion

1.	Syringe brand selection:	capacity brand and type
		syringe list given as an example
	Drug name selection:
	(according to device	$GUH
	configuration: 3$U&)
		(e.g.: ADRENALIN)
2.	Prime the line:	3XU*

(continuous nd press)

3.Connect infusion set to patient and check general installation.

4. Flowrate setting (ml/h):

10

1

0.1

(e.g.: flow rate 5.2 ml/h)

5. Starting the infusion:

Important: flow rate may be programmed during infusion and must be confirmed within 15 seconds following the change. Proceed as described above to change the syringe.

Infused volume

Consulting the infused volume:

Erasing the infused volume:

(continuous press)

Volume limit

Programming a volume limit (ml):

Programmed volume limit recall:

Erasing programmed volume limit:

10	1	0.1

(double press)

(double press)

(continuous press)

Bolus function

Administering a bolus (ml):	EROX

(continuous press)

Changing bolus rate (ml/h):

(continuous press)

STOP and Pause

Stop (sound warning after one minute):

To resume infusion:

Pause duration selection, from 1 min to 9 hrs 59 min:

(double press)

Ending Pause and resuming infusion:

Occlusion alarm threshold setting

3 occlusion pressure limits available. Selection is adjusted manually by a safety located on the rear of the syringe drive.

Lower limit

Middle limit

Upper limit

OFF

To turn off the Pilot :

(press for more than 2 seconds)

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Internal safety features

The Pilot device have a continuous inspection system which functions as soon as the pump is in use.

Nevertheless, the qualified personnel in your establishment or our After-Sales Department should always be notified of any abnormal function where no specific cause can be found.

In case of single fault condition, an alarm is activated within the limit of 5% rate deviation. In addition, a secondary control feature activates an alarm at 1 ml over infusion or 20% rate deviation, whichever is shortest.

Note: the battery automatically takes over when the mains supply is disconnected.

Prealarms and alarms With visual and audible signal.
Checks		Infusion				Activation		Message
				Silence alarm
		Stop
Battery	Prealarm	NO		YES		low battery		Battery alarm + prealarm indicators
	Alarm	YES		YES (2 min)		discharged battery		Battery alarm + alarm indicators
							Note: memorisation of programmed parameters (10
							min). Connect device to mains.
Mains	Disconnection	NO		YES		mains disconnected	E$W messsage displayed.
							Press to acknoledge this warning.

Infusion End of infusion prealarm	NO	YES	5 minutes before end of
			infusion alarm or 10% of total
			syringe capacity.

Prealarm + end of infusion indicators

Note: to use Empty syringe mode press CONFIRM key.

End of infusion alarm

YES

YES

Syringe empty (theory)

Alarm + end of infusion indicators

Note: to use Empty syringe mode press CONFIRM

key.

Empty syringe

YES

YES

Total syringe empty

Prealarm + end of infusion indicators

Volume

Prealarm

NO

YES

5 minutes before the volume

Prealarm + flashing ml indicators

limit

limit alarm or 10% of syringe

capacity.

Alarm

KVO rate

YES (2 min)

Volume limit reached

Alarm + KVO + ml indicators

Pressure

Occlusion alarm

YES

YES (2 min)

Programmed limit reached

Flashing alarm +

occlusion indicators

Syringe

Syringe barrel clasp

YES

YES (2 min)

Syringe incorrectly positioned

Alarm + syringe barrel clasp

installed

Syringe flanges insertion

indicators

Plunger head position

YES

YES

Syringe incorrectly positioned

Alarm + plunger head position

Anti-siphon systems

indicators

Disengaged mechanism

YES

YES

Drive systems not engaged

Alarm + disengaged mechanism

indicators

Others

Unconfirmed program or

---

NO

No confirm > 15 seconds

● Flashing confirm indicator

alarms

flow rate = 00.0 ml/hr

No syringe selection

YES

YES

no syringe selection > 1 min

● Flashing confirm signal + flashing capacity and

brand syringe indicators

Key disabled

NO

NO

Pressing an unauthorised

Audible signal only

key

Programmed end of

YES

NO

Programmed end of pause

Alternating displays of flow rate value and 6W23

pause

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Checks	Infusion	Silence alarm	Activation		Message
	Stop
Malfunction alarm	YES	YES	Device cannot check the		Technical malfunction + alarm indicators
			infusion
Error message : (U	YES	YES	Motor rotation control	(U--	Error message + technical
			anomaly
				malfunction + alarm indicators
				Press STOP to resume the device normal operation
Error messages : (U ; ; ;	YES	YES	Electronic control anomaly	(U--	Error message + technical
; ; ; ; ; ,
				malfunction + alarm indicators
Error message : (U	YES	NO	Keyboard anomaly	(U--	Error message + technical

malfunction + alarm indicators

Error messages : (U ; ; ;	YES	YES	1 ml deviation/ volume to be
			infused

(U-- Error message + technical malfunction + alarm indicators

Preventive maintenance warning	NO	---	Date of maintenance	&WU/ message only displayed when the device is
			reached (3$UE)	turned on).
				Press CONFIRM to continue.
				Warning: check the device as soon as possible.

Note: in case of malfunction alarm, note the error message ((U ) and stop the device by pressing the OFF key (5 - 10 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 AfterSales Department.

The sound level can be set by rotating the shutter placed underneath the device .

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Performances

Flow rates

The values given in the table below correspond to device configuration.

	Syringes
	50/60 ml	20 ml
Infusion flow rate (ml/h)	from 0.1 to 200.0	from 0.1 to 120.0
Bolus rate (ml/h)	from 50.0 to 500.0	from 50.0 to 275.0
Prime rate (ml/h)	500.0	275.0
0.1 ml/h increments.

Volume limit

Volume limit (ml)	from 1 to 99.9 ml, 0.1 ml increment
	from 100 to 999 ml, 1 ml increment

KVO rate (Keep Vein Open): 1 ml/h or flow rate originally selected if this is less than 1 ml/h.

Display of the name of the drug

According to configuration (3$U&).

It is possible to display periodically during infusion the name of the drug used. 15 names of drugs may be programmed by configuration (3$U*).

Pressure limit

Pilot A2 proposes a choice of 3 occlusion alarm thresholds.

		Syringes
		50/60 ml	20 ml
Threshold value	lower z	300	600
(mmHg)	middle zz	500	1000
	upper zzz	900	1700

Values given for B-D Plastipak® Luer Lok® syringes.

Note : 1 bar = 750 mmHg = 1000 hPa.

Accuracy

Flow rate accuracy	± 3 % with pre-programmed syringes
Device accuracy	± 1%
Syringe accuracy	± 2%

Pause duration

From 1 minute to 9 hours 59 minutes, 1 min. increments.

Syringe type list

The Pilot A2 recognises the size of the installed syringe. The last syringe brand used is proposed when the device is turned on.

Brands and types	50/60 ml	20 ml
B-D PLASTIPAK	T	T
FRESENIUS INJECTOMAT	T
BRAUN OMNIFIX	T	T
BRAUN PERFUSOR	T	T
PIC INDOLOR	T
TERUMO	T	T

Different syringe lists are available. For further information, please contact our Customer Service.

Fresenius Vial cannot accept any responsibility for errors in flow due to modifications of the specifications of the syringes introduced by the manufacturer.

Occlusion alarm response time versus infusion flow rate

These values are representative of syringes used during trials with an Pilot A2 and serve as an indication only of the pump’s overall performance.

			Threshold values
	Flow rate	lower z	middle zz	upper
				zzz
Syringe	1 ml/h	40’	60’	120’
50/60 ml	5 ml/h	8’	12’	20’
	120 ml/h	25’’	35’’	50’’

Syringe used: B-D Plastipak® Luer Lok® (B-D Plastipak and Luer Lok are registered trademarks of Becton Dickinson).

Bolus volume on occlusion release

		Threshold value
	lower z	middle zz	upper zzz
50/60 ml syringe	≤ 0.2 ml	≤ 0.4 ml	≤ 0.8 ml
20 ml syringe	≤ 0.2 ml	≤ 0.4 ml	≤ 0.8 ml

Note: wait until the Alarm + occlusion + flashing indicators turns on, indicating the bolus has been reduced.

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