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PATIENT USER GUIDE

PATIENT USER GUIDE

CANÈ S.p.A. Medical TechnologyVia Cuorgnè 42/a 10098 Rivoli (TO) Italy

Tel.+39 011 9574872 - Fax +39 011 9598880www.canespa.it - [email protected]

Manual code: MAN 01/06/USA/p CRONO PCA 50 04/10Firmware version: PD.02.03

Data firmware: 04/07/07

5

TABLE OF CONTENTS

MAN 01/06/USA/p CRONO PCA 50 04.10

SECTION 1Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .page 9Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .page 9Note . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .page 12Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .page 12Information-Technical assistance . . . . . . . . . . . . . . . . . . . . . . . . .page 12

SECTION 2Description of the pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .page 13Infusion system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .page 14Technical features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .page 14Factory settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .page 16

SECTION 3Standard equipment supplied . . . . . . . . . . . . . . . . . . . . . . . . . . . .page 17Optional accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .page 18How to use the standard equipment supplied . . . . . . . . . . . . . . .page 20How to wear the pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .page 22

SECTION 4Pump overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .page 23Liquid crystal display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .page 25Main screen indications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .page 25Key-pad . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .page 27

SECTION 5Identification of the reservoir parts . . . . . . . . . . . . . . . . . . . . . . . .page 28Luer-lock cap . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .page 29Profill-crn needle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .page 29Filtrajet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .page 30Infusion set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .page 30Preparation for infusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .page 30Anti-Siphon valve . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .page 31Réservoir preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .page 32Connecting the réservoir to the pump . . . . . . . . . . . . . . . . . . . . . .page 34Safety system to avoid free-flow . . . . . . . . . . . . . . . . . . . . . . . . . .page 35Warning safety system to avoid free-flow . . . . . . . . . . . . . . . . . . .page 36

6MAN 01/06/USA/p CRONO PCA 50 04.10

SECTION 6Device activation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .page 37

SECTION 7Key-pad lock out . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .page 38Table of key-pad lock-out levels . . . . . . . . . . . . . . . . . . . . . . . . . .page 39

SECTION 8Programming . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .page 40Programming of flow rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .page 42Programming of bolus dose . . . . . . . . . . . . . . . . . . . . . . . . . . . . .page 43Minimum interval time between bolus doses . . . . . . . . . . . . . . . .page 44Programming of bolus doses per hour . . . . . . . . . . . . . . . . . . . . .page 46Programming of partial volume . . . . . . . . . . . . . . . . . . . . . . . . . . .page 48

SECTION 9Starting the pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .page 50Priming . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .page 51Pump in on (running) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .page 53Bolus dose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .page 54Bolus dose limitations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .page 55Clinician bolus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .page 56Occlusion of infusion set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .page 57Post occlusion bolus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .page 57End of infusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .page 58Reversal of the pump pusher . . . . . . . . . . . . . . . . . . . . . . . . . . . .page 59Switching off the pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .page 61

SECTION 10Displaying programmed parameters . . . . . . . . . . . . . . . . . . . . . . .page 62Displaying deliverd volumes . . . . . . . . . . . . . . . . . . . . . . . . . . . . .page 64Clearing the number of bolus doses delivered . . . . . . . . . . . . . .page 66Displaying the number of complete infusions . . . . . . . . . . . . . . . .page 67

SECTION 11Low battery alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .page 69


Battery installation or replacement . . . . . . . . . . . . . . . . . . . . . . . .page 70

SECTION 12General cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .page 72User guide update . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .page 72Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .page 73Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .page 73Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .page 73Expected life of the pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .page 73Disposal of the pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .page 73User information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .page 74

SECTION 13Manufacturer’s guarantee . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .page 75

SECTION 14Alarm message . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .page 77Short instruction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .page 79

SECTION 15Pump icon table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .page 83Réservoir blister package icon table . . . . . . . . . . . . . . . . . . . . . . .page 84

SECTION 16Statement of conformity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .page 85Note . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .page 86

SECTION 17Glossary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .page 87

ANNEX Annex 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .page 89Annex 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .page 91Annex 3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .page 92Annex 4 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .page 94

SECTION 1

9

INTRODUCTION


WARNINGS

CAUTION: US Federal law restricts this device for sale by or on orderof a physician.The instructions included in this manual are intended only for the ambula-tory drug infusion pump CRONO PCA 50 and are addressed to the pumpuser.

The pump is provided with key-pad lock-out in order to avoid accidental ornon authorised variations of the selected parameters.

The information as to lock or unlock the key-pad are exclusively addressedto the physician.

When the key-pad is locked any attempt to modify the protected parameterswill cause the indication Lo,1 to appear on the screen.

Do not use the Crono PCA 50 without first reading and understandingthe complete pump user guide. Improper programming and/or incom-plete understanding of the operating functions and of the warningscould result in death or serious injury to the patient.

Keep the user guide together with the pump for references.

Before using the pump for a specific infusion therapy check the suita-bility of the device for the use and for the patient considering carefullythe following aspects:

• the technical specifications of the pump;• the infusion set that will be used;• the eventual use of infusion set with various lines and clamps along

the infusion line;• the kind of therapy for which the patient has to undergo;• the psycho-physical and cognitive condition of the patient.

The above list given is only an illustration, not exhaustive, concerningthe procedural clinical aspect whose responsibility is on the part of thedoctor or the medical assistant.

10

SECTION 1


The pump must be used:• under strict medical control,• using proper procedure and suitable measure to the patient that could

suffer serious consequences (injury or death) following involuntary misuse and/or device failure with consequently interruption of the drugadministration.

Do not prime any kind of tubing when connected to a patient, as thiscould result in over-delivery of medication and air embolism.

Eliminate all air bubbles in all lines before starting an infusion to avoidair embolism.

Inspect the whole fluid path for kinks or closed clamps or any otherobstruction before the infusion is started.

Accuracy, time to an occlusion alarm signal and post-occlusion bolussize may deviate from the information in this user guide depending onwhich type of extension sets, tubing and access devices that are usedfor the administration of a medication (details are supplied on ANNEX 1,2 and 3).

The improper connection between the syringe piston and the pump pus-her can cause a free flow of medication, in other words, medicationadministered by gravity and not controlled by the pump, (for examplewhen the pump is positioned much higher than the infusion site). Such situation can cause serious injury or death of the patient.

If you know or suspect that the pump has been damaged in any way, forexample through water or impact, please contact your local CustomerService representative to verify if the pump is operational. Do not use apump that is damaged.

Liquid on the outside of the pump should be wiped off immediately witha soft cloth. Please observe that any liquid penetrating the pump can

SECTION 1


cause serious damage to the pumps’ electronic circuits.

Epidural drug infusions delivering drugs different from the ones specificallyindicated for those kinds of administrations can cause serious lesions ordeath.

CANÈ S.p.A. recommends an annual check up on all Crono PCA 50pumps with the aim of evaluating the correct function and accuracy. Suchcheck ups must be carried out only by CANÈ S.p.A. or an authorized dis-tributors.

SECTION 1


NOTE

INTENDED USE

INFORMATION – TECHNICAL ASSISTANCE

The manufacturer only takes the responsibility for the safety and reliabilityof this pump, provided that it is used in accordance with the current instruc-tions for use and only in case any repairs and changes to the device aremade exclusively by the manufacturer.

The ambulatory infusion pump of drug Crono PCA 50 has been designed tobe used in the pain treatment for subcutaneous, intravenous and epiduralinfusions.

The pump is not designed for life sustaining treatments.

For further information, technical assistance or if you have questions concerning the operation of the pump, please contact:

UNITED STATES:INTRA PUMP INFUSION SYSTEMS401 Southwestern Blvd., Suite 160,Coppell, TX 75019Tel: 866-211-7867Fax: 630-845-2768Email: [email protected]

MANUFACTURER:CANÈ S.p.A. MEDICAL TECHNOLOGYVia Cuorgnè, 42/a Rivoli (TORINO) ItalyTel: 0039-011-9574872Fax: 0039-011-9598880Email: [email protected]

SECTION 2

13

DESCRIPTION OF THE PUMP


Crono PCA 50 is a new, innovative PCA pump that is very appreciated byhealth care professionals and patients due to its small size, 50 ml reservoirand convenience to use and operate.Crono PCA 50 is an ambulatory infusion pump especially suited for control-led drug administration on patients in hospital or undergoing a therapy athome.The pump is suitable for subcutaneous, intravenous and epidural infusionsallowing 4 different administration modalities:1. Continuous2. Bolus dose upon request (PCA)3. Clinician bolus (managed by clinician)4. Combined (continuous + bolus upon request + clinician bolus)

The chart below explains the different combined methods of administration.

The pump is provided with key-pad lock-out functions in order to avoid un-authorized reprogramming of the drug administration protocol.The liquid crystal display (LCD) shows the information which are helpful bothfor the clinician and the patient like programming, reading of administereddrug volumes and control functions of the pump.

Clin

icia

nB

olus

Bol

usdo

seup

onre

ques

t

Continuous

Bol

usdo

seup

onre

ques

t

t

ml

Clin

icia

nB

olus

14

INFUSION SYSTEM

TECHNICAL FEATURES


Pump size 84.5 x 55 x 42 mm.

Weight 140 g (battery included).

Battery CR 123A 3V Lithium battery (battery life: about 3 months/80-100 infusions).

Réservoir 50 ml dedicated with luer-lock connector

Administration volumes From 1 ml to 50 ml with increments of1 ml.

Priming Available only at the beginning of an infusion or partial infusion. The maxi-mum deliverable volume is 1.5 ml with0.5 ml increments.

Flow rate Programmable from 0.05 to 35 ml/h with the following increments:- from 0.05 to 10 ml/h with 0.01 ml/h

increments;- from 10 to 35 ml/h with 0.05 ml/h

increments;The flow rate can be programmed to 0 ml.

Bolus dose Programmable from 0.10 to 9.98 ml with 0.02 ml increments:The bolus dose can be programmed to 0 ml.

Clinician bolus Programmable from 0.10 to 9.98 ml with 0.02 ml increments:This function is always locked.

Minimum time between bolus doses Programmable from 5’ to 24 h as follows:- from 5' to 1h with increments of 5';- from 1 h to 24 h with increments of 15';- this function can be deactivated by

programming 0.

SECTION 2

The pump administers shots of 20 µl for any given flow rate. The timeinterval between shots decrease proportionally to increases in program-med flow rates.


Number of boluses doses per - from 1 to 12 boluses.hour - this function can be deactivated by

programming 0.

Flow accuracy +/-3% (observation period 40 minutes).

Max. occlusion pressure 2.2 bar +/-0.8.

Time to an occlusion alarm Please, see ANNEX 2.

Post-occlusion bolus About 1.5 ml (details are supplied on ANNEX 3).

Electric circuit Electric circuit managed by a microcontroller equipped with a dedicated software.

Data storage The selected data are automatically stored in the pump memory and they are not lost when the battery is removed.

Display LCD.

Motor Direct current coreless motor. The microcontroller manages the rotation through infrared encoder.

Safety circuits To monitor the correct working of the device intervening in case of anoma-lies with acoustic warnings and error messages.

Anti free-flow system To avoid a non controlled flow inside the delivery set due to the force of gravity.

Operating conditions +10°C / +45 °C 30% / 75% RH700 hPa / 1060 hPa

Storage conditions -10°C / +60 °C 10% / 100% RH 500 hPa / 1060 hPa

SECTION 2

The following factory settings are programmed at the delivery of the pump:

Key-pad lock-out level L 0

Flow rate 0.80 ml/h

Bolus dose 0.20 ml

Interval between bolus doses 1 h

Number of bolus doses in 1 hour 1

Volume 50 ml

Clinician Bolus c0.00 ml

Number of infusions 0

16

FACTORY SETTINGS


SECTION 2

SECTION 3

17

STANDARD EQUIPMENT SUPPLIED


1. Ambulatory infusion pump.2. Pump case.3. Elastic belt.4. Collar strap. 5. Fabric holder.6. 2 batteries (one already inserted in the pump).7. Battery tool.8. 2 users guides (physician and patient).

1

2

3

5

46

7

8

18

OPTIONAL ACCESSORIES

SECTION 3


Optional accessories are available upon request:1. Vertical leather holder similar to a mobile telephone carrying case.


2. Horizontal leather holder similar to a spectacle case.

SECTION 3


3. Dedicated plastic carrying case with external access to the bolus buttonand transparent window visualising the display.

SECTION 3

21

HOW TO USE THE STANDARD EQUIPMENT SUPPLIED


The following illustrations show how the pump and its accessories can beset up.

How to attach collar strap to the pump and the fabric holder.

How to use elastic belt with pump and fabric holder.

10

20

30

ml

40

50

SECTION 3

22

HOW TO WEAR THE PUMP


The following pictures show thevarious ways the pump can beworn.

Wearing the pump around theneck.

Wearing the pump around the neckwith a collar strap and a fabric hol-der.

Wearing the pump at the waist.

Wearing the pump at the waist withan elastic belt and a fabric holder.

SECTION 3

SECTION 4


PUMP OVERVIEW

Display

Button

Pusher

Button Button

Battery compartment

Shortinstructions

Serial number

CE mark

Collar straplocking rings

Réservoir fin hook

- +d

24

LIQUID CRYSTAL DISPLAY (LCD)

SECTION 4


This is a screen on the front of the pumpwhere symbols and messages are displayedinforming the user about operations in pro-gress as well as giving warnings and alarmmessages.

“Low battery” symbol:appears when the battery charge is low (seepage 69).

“Drip” symbol:separates whole numbers from decimals.

“Apostrophe” symbol: used when the duration of infusion is givenin minutes.

10

20

25

MAIN SCREEN INDICATIONS


Pump OFF

Prime function

Prime execution

Flow rate

Time left to end of infusion (hours)

Time left to end of infusion (mins.)

Bolus dose

Minimum time interval between boluses

No time interval between boluses

Number of bolus doses in 1 hour

No restriction of bolus doses per hour

Partial volume

Operation not performed

Pump unlocked

Pump locked

Number of delivered infusions

Error message (see page 77)

10

20

10

20

10

20

10

20

10

20

10

20

10

20

10

20

10

20

10

20

10

20

10

20

10

20

10

20

10

20

10

20

SECTION 4


Occlusion

Feed/reversal motion of the pumppusher

End of infusion

Low battery

Battery discharged

Volume delivered (ml) as basal flowrate

Volume delivered (ml) as bolus doses

Number of bolus doses already deli-vered Volume delivered (ml) as clinicianbolus Total volume delivered (ml) (basal flowrate + bolus doses + clinician bolus)

10

20

10

20

10

20

10

20

10

20

10

20

10

20

10

20

10

20

10

20

SECTION 4

The above screens are given as example of what can be displayed.

CAUTION

Press the buttons with your finger-tips only, do not use sharp or poin-ted objects.

27

KEY-PAD


The key-pad has 3 buttons for pro-gramming and the operation of thepump.

The buttons are time-controlled:keep buttons pressed for a fewseconds to activate commands.

• Buttons activation is confirmed by a ticking sound, except when inserting the battery.

• Command execution is confirmed by a brief acoustic signal.

During the selection of the parame-ters the button is used todecrease the value displayed onthe screen, the button to increa-se the value.

SECTION 4

NO

YES

Rod

Luer-Lock Cap(detachable)

CAUTION

For safety purposes, it is advisableto use original CRN® Crono®Reservoir syringes.

The use of different reservoirs cancause damage both to the pumpand to the user.

CANÈ S.p.A. assumes no responsi-bility if the instrument is used withsyringes that are not original and dif-ferent from the recommended ones.

Réservoir body

Piston

SECTION 5


The Crono 50 pump uses special50 ml reservoirs.

Features of the reservoir:• Sterile.• Single use only.• Apyrogenic.• To be used only if packging is not

damaged.

IDENTIFICATION OF THE RESERVOIR PARTS

SECTION 5


PROFILL-CRN NEEDLE

The luer lock cap is attached to thereservoir rod, from which it must bedetached by pressing down slight-ly. Functions of the luer lock cap:

• When the reservoir has been filled, it helps unscrew the rod from the piston;

• It makes it easy to establish correct connection between the pump pusher and therubber piston of the syringe;

• It protects the medicine inside the reservoir if it is not used immediately.

LUER LOCK CAP

Use the PROFILL-CRN needle to:• pierce the rubber membrane of

drug containers;• suction the drug to fill the 50 ml

reservoir.

Features of the needle: 14G - 38mm (1.5 inch), sterile, disposable,apyrogenic, useable only in sealedpack.

CautionDo not use the needle for performinginjections and/or blood drawing.

Luer Lock cap

Needle cover Male Luer Lock Cap

Needle

SECTION 5


OFF

MICROJ

ET CRO

NO

0.2 ml

d

h

min

INFUSION SET

PREPARATION FOR INFUSION

FILTRAJET

For information about infusion sets, please see the instruction supplied with the products.

Before the pump and other disposa-bles are prepared to be used, makesure that you take the following pre-cautions to avoid any contamination:

1. Wash your hands;2. Prepare a clean working area.

Filter can be used that:

• Prevent bacterial infections.• Eliminate air in the réservoir and

in the infusion set.• Trap any fragments of glass or

plastic to secure a safe and proper drug administration.

Male Luer Lock cap

Female Luer Lock cap

0.2 micron filter

Tube set @ 1 x 2.3 PVC-NO DOP

Blue Male Luer Lock connector

Female Luer Lock cap

SECTION 5


ANTI-SIPHON VALVE

Performance specificationCracking Pressure 3.5 PSI +/- 1

Back Pressure > 45 PSI

Flow @ 5 PSI 203 ml/min

Static Position Closed

Applications Liquids and Air

In case of intravenous or epidural infusion, the use of an anti-siphon valvealong the administration line is recommended, as an additional safety devi-ce to avoid any free flow from occurring, should the operator not attach thesyringe piston to the pushing unit of the pump.

Flow

Flow rate

Flow rate (cc/min)

Pressure (psi)

Pre

ssu

re (

psi

)

Cracking Pressure non flow rate dependent

Flo

w r

ate

(ml/h

ou

r)

SECTION 5


1 Unscrew the male luer lock cap from the PROFILL - CRN needle;

2 Screw the needle on to the reservoir turning it clockwise, and remove theneedle cover;

3 Fill the reservoir by drawing up the liquid slowly and checking that the amount of drug does not exceed the 50 ml capacity or the partial volume set;

RESERVOIR PREPARATION

1 2 3

4 Screw the luer lock cap on to the reservoir and unscrew the rod turning itanticlockwise with a slightly rapid movement;

5 Fit the reservoir on to the pump with a rotation of 90°; a click confirms thatit is locked (see pages 34);

6 Screw the infusion set cone on to the reservoir.

SECTION 5


4 5 6

WARNINGThe piston must not be removed from the syringe

SECTION 5


Fit the special CRN 50 reservoir on to the pump with a rotation of 90°; aclick confirms that it is locked.

CONNECTING THE RÉSERVOIR TO THE PUMP

Top view

The term “freeflow” means a pos-sible uncontrolled administrationof drug caused by the effect of theforce of gravity.To avoid this, the pusher is fittedwith a special profile that is fittedinside the rubber piston of thereservoir keeping it attached tothe latter.

CAUTION

The efficacy of the safety systemis guaranteed only if there is a cor-rect fitting between rubber pistonand pusher, as shown in figure.

In case of intravenous or epiduralinfusion, the use of an anti-siphonvalve along the administration lineis recommended, as an additionalsafety device to avoid any freeflow from occurring, should theoperator not attach the syringepiston to the pushing unit of thepump.

SECTION 5


NO

YES

SAFETY SYSTEM TO AVOID FREE-FLOW

SECTION 5


The reservoir must be completely filled to allow the connection of the rubberpiston to the pushing unit.The rubber piston of the reservoir must be connected to the pushing unit ofthe pump; if this does not occur the following conditions may happen:

• The start of the infusion is delayed and it is performed inaccurately.• The connection between pusher and piston is not correct and therefore the

safety of the anti-freeflow system is not guaranteed

The improper connection between the syringe piston and the pump pushercan cause a free flow of medication, in other words, medication administeredby gravity and not controlled by the pump, (for example when the pump ispositioned much higher than the infusion site). Such situation can causeserious injury or death of the patient.

WARNING SAFETY SYSTEM TO AVOID FREE-FLOW

SECTION 6

37

DEVICE ACTIVATION


When you insert the battery the pump starts asequence of activation during which:

1.The pump will carry out a self-test with briefacoustic signals and all symbols will appearon the screen.

2.The pump’s mechanical pusher will place itself in the correct starting position and at the end of this self-adjusting, OFF will appear on the screen.

NOTE

• The pump is supplied with a battery alreadyinserted.

• Refer to the relevant paragraph for instruc-tions how to insert a new battery (see page70).

• Take out the battery of the pump if it is not going to be used for a long period of time

(1-2 months).

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20

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CAUTIONS

• The key pad lock-out is retai-ned even when the battery isremoved.

• When the key-pad is locked any attempt to access protec-ted operations is signalled bythe device through an acou-stic message and L 1 will appear on the screen.

SECTION 7

38

KEY PAD LOCK OUT


The pump is provided with a key-padlock-out in order to avoid non authorisedor accidental variations of the selectedparameters.

The Crono PCA 50 pump has 2 locklevels:• L 0: permits complete access to all

settings and operating functions.• L 1: permits restricted control of ope-

rating functions.

Before proceeding to the pump settingsmake sure that the lock level selected isL 0.

The information relating to the operationsof key-pad lock/unlock are exclusively tobe used by the physician.

The following table lists the accessible operations at any key-pad lock-outlevel (L 0 or L 1) both when the pump is in OFF and ON condition.

SECTION 7

39

TABLE OF KEY-PAD LOCK-OUT LEVELS


OPERATIONS AND SELECTIONS

Switching ON the pump

Switching OFF the pump

Prime

Bolus dose

Displaying delivery time

Displaying volume delivered as flow rate

Displaying volume delivered as bolus dose

Displaying number of bolus dose delivered

Clearing the number of bolus doses delivered

Displaying volume delivered as clinician bolus

Displaying total volume delivered

Displaying programmed parameters

Flow rate setting

Bolus dose setting

Interval between bolus doses setting

Number of bolus dose in one hour setting

Partial volume setting

Displaying the number of complete infusions

Clearing the number of complete infusions

Lock/Unlock the keyboard

Clinician bolus

OFF ON

L0 L1 L0 L1

YESYES NO NO

YESYES NO NO

YESYES NO NO

YESYES NO NO

NO NO YES YES

NO NO YES YES

NO NO YES YES

NO NO YES YES

NO NO YES YES

NO NO YES YES

NO NO YES YES

NO NO YES YES

NO NO YES YES

YES NO NO NO

YES NO NO NO

YES NO NO NO

YES NO NO NO

YES NO NO NO

YES NO NO NO

YES NO NO NO

NO NO YES*YES*

* Available only at the beginning of a new infusion or a new partial infusion.

SECTION 8

40

PROGRAMMING


For programming, the pump must be:• In OFF condition.• With key-pad lock-out in L0.

Depress the button for about 1 second to access the pump program-ming sequence. The first programming option displayed on the screen isflow rate. The flow rate can be changed with the button or the but-ton as long as the presently programmed flow rate is flashing.

The second depressing of the button will display the second program-ming option bolus dose volume. The bolus dose volume can be changedwith the button or the button as long as the presently programmedbolus dose volume is flashing.

The third depressing of the button will display the third programmingoption minimum time interval between bolus doses. The minimum timeinterval between bolus doses can be changed with the button or the

button as long as the presently programmed minimum time is flashing.

The fourth depressing of the button will display the fourth programmingoption number of bolus doses per hour. The number of bolus doses perhour can be changed with the button or the button as long as thepresently programmed number of bolus doses per hour is flashing.

The fifth depressing of the button will display the fifth programmingoption partial volume. The partial volume can be changed with the button or the button as long as the presently programmed partial volu-me is flashing.

The pump can only be programmed when the pusher is in the start posi-tion.

NOTEIf the key pad lock-out is programmed to L1, depressing the button willdisplay L1 (key pad lock-out: indicating that lock-out programming func-tions can not be reprogrammed in lock-out L1).

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d

d

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d

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d

d

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SECTION 8


OFF

Flow rate

Bolus dose volume

Minimum time interval between bolus doses

Number of bolus doses per hour

Partial volume

The following screen displays are examples of programmed values as theyappear on the screen.

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SECTION 8

42

PROGRAMMING OF FLOW RATE


The flow rate can be programmed from 0,05ml/h to 35 ml/h as follows:• From 0,05 ml/h to 10,00 ml/h with incre-

ments of 0,01 ml/h• From 10,00 ml/h to 35,00 ml/h with incre-

ments of 0,05 ml/h

Programming procedure:1. When the button is depressed for

about 1 second with the pump in OFF condition: the presently programmed flow rate will be displayed and flashing

2 . By depressing the button the value willincrease; by depressing the button the value will decrease. Any change in value is followed by an acoustic signal.

3. If no button is depressed within 5 secondsin the programming phase, this phase ends and the value stops flashing and OFF appears on the screen.

4. Depressing the button before the OFFmessage appears (the flow rate value is still flashing) moves the programming sequence to the next option: bolus dose.

NOTE• F appears before the value when the flow

rate is less than 10,00 ml/h.• You can accelerate (scrolling) the display of

new values by depressing the or the button continuously (in increments of 0,40 ml/h).

• Programmed flow rates are automatically stored.

• By programming F0,00 the flow rate is elimi-nated.

SECTION 8

43

PROGRAMMING OF BOLUS DOSE


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The bolus dose can be programmed from 0,10ml to 9.98 ml with increments of 0.02 ml.

The bolus dose is accessed by the seconddepressing of the button in the pump pro-gramming sequence (see page 41).

Programming procedure:1. When the button is depressed for a

second time, a "d" is displayed and the presently programmed bolus dose is flas-hing.

2. By depressing the button the value willincrease; by depressing the button the value will decrease. Any change in value isfollowed by an acoustic signal.

3. If no button is depressed within 5 seconds in the programming phase, this phase endsand the value stops flashing and OFFappears on the screen

4. Depressing the button before the OFFmessage appears (the bolus dose is still flashing) moves the programming sequen-ce to the next option: minimum time interval between bolus doses.

NOTE• You can accelerate (scrolling) the display of

new values by depressing the or the button continuously (in increments of 0,20 ml/h).

• Programmed bolus doses are automaticallystored.

• By programming d 0,00, the bolus dose is eliminated.

SECTION 8

44

MINIMUM TIME INTERVAL BETWEEN BOLUS DOSES


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The minimum time interval between bolusdoses can be programmed from 5 minutes to24 hours as follows:

• From 5 minutes to 1 hour with increments of5 minutes.

• From 1 hour to 24 hours with increments of15 minutes.

This function limits the patient to access theprogrammed bolus dose before a certain timehas elapsed from the latest administeredbolus dose.

The minimum time interval between bolusdoses is accessed by the third depressing ofthe button in the pump programmingsequence (see page 41).

Programming procedure:

1. When the button is depressed for a third time, a "t" is displayed and the pre-sently programmed interval time is flashing.

2. By depressing the button the value will increase; by depressing the buttonthe value will decrease. Any change in value is followed by an acoustic signal.

3. If no button is depressed within 5 secondsin the programming phase, this phase ends and the interval time stops flashing and OFF appears on the screen.

4. Depressing the button before the OFFmessage appears (the interval time is still

SECTION 8


10

20

flashing) moves the programming sequenceto the next option: bolus doses per hour.

NOTE

• "t" appears only before the programmed interval time when the interval time is less than 10 hours.

• You can accelerate (scrolling) the display ofnew values by depressing the or the button continuously (in increments of 5 respective 15 minutes, see above).

• Programmed interval time is automatically stored.

• By programming "no,Lt", the minimum time between bolus doses is eliminated.

SECTION 8

46

PROGRAMMING OF BOLUS DOSES PER HOUR


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The number of bolus doses per hour can beprogrammed between 1 and 12 boluses perhour.This function limits the patient to access moreboluses per hour than programmed.The number of bolus doses per hour is acces-sed by the fourth depressing of the buttonin the pump programming sequence (seepage 41).

Programming procedure:

1. When the button is depressed for a fourth time, an "n" is displayed and the pre sently programmed number of bolus doses per hour is flashing

2. By depressing the button the value willincrease; by depressing the button thevalue will decrease. Any change in value is followed by an acoustic signal.

3. If no button is depressed within 5 secondsin the programming phase, this phase ends and the number of bolus doses per hour stops flashing and OFF appears on the screen.

4. Depressing the button before the OFFmessage appears (the number of bolus doses per hour is still flashing) moves theprogramming sequence to the next option:partial volume.

Please observe that partial volume is onlyavailable at the beginning of a new or newpartial infusion.

NOTE

• Programmed bolus doses per hour is automatically stored.

• By depressing the button when the dis-

SECTION 8


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20

play is showing "n 1", will eliminate the bolus dose per hour function and the dis-play will show "n 0", which means that no boluses can be administered.

• By depressing the button when the dis-play is showing n 12, will eliminate the bolus number per hour restriction and the display will show no,Ln, which means that there is no longer any restriction how manyboluses that can be administered by the patient.

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SECTION 8

48

PROGRAMMING OF PARTIAL VOLUME


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Partial volume is used when less than 50 ml isdrawn up in the syringe for a specific treatmentor for a specific patient, for example childrenwho needs less than the adult dose.Partial volume can be programmed between 1ml to 50 ml with increments of 1ml.Partial volume is accessed by the fifth depres-sing of the button in the pump program-ming sequence (see page 41). Please observe that partial volume is onlyavailable at the beginning of a new or new par-tial infusion.

Programming procedure:1. When the button is depressed for a

fifth time, the presently programmed volu-me in ml is flashing:

2. By depressing the button the value willincrease; by depressing the button thevalue will decrease. Any change in value isfollowed by an acoustic signal.

3. If no button is depressed within 5 secondsin the programming phase, this phase ends and the selected volume in ml stopsflashing and P,cc appears on the screen.

4. The pusher will automatically position itselffor the programmed partial volume. Duringthe movement of the pusher, there will bean acoustic signal and the delivery time corresponding to the selected partial volu-me will be displayed on the screen.

5. When the pusher reaches its programmedposition, the display will show OFF.

WARNINGS• Do not perform this ope-

ration with an infusion set attached to the syrin-ge.

• It is not possible to repro-gram the partial volume during an ongoing infu-sion.

• The partial volume is automatically stored untilyou remove or replace the battery at which timethe programmed volumewill revert to the standardvolume of 50 ml.

SECTION 8


NOTE

• Partial volume is automatically stored for thenext delivery, unless reprogrammed.

• At the end of a partial infusion the pusher moves automatically back to the program-med partial volume position.

• By depressing the button and buttonsimultaneously, the movement of the pusheris interrupted and OFF is displayed on the screen. This position of the pusher is not stored but the programmed partial volume remains active.

SECTION 9

50

STARTING THE PUMP


Depress the button when the pump is inOFF and there will be a short acoustic signaland the display will show either:

• Pr (priming function) provided that the pusher is in the start position for a new, fullor partial volume, infusion

or

• remaining infusion time in hours and (minutes) when the pump is restarted during an ongoing infusion

NOTE

The count down of remaining infusion time isdisplayed on the screen in full hours until lessthan one hour remains, when the pump swit-ches to display remaining infusion time inminutes.

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WARNINGSBefore starting an infu-sion:• make sure that the

syringe and the secu-rity system in order to avoid the free flow arecorrectly connected;

• inspect the flow line in order to check that there aren’t any kinks, closed clamps and other occlusions befo-re proceeding;

• eliminate eventual air bubbles.

WARNINGS

• Do not prime the infusionset when attached to thepatient.

• The infusion set should be attached to the reser-voir before priming starts

• The infusion set must becompletely filled before itis attached to the patient.

• Check that all air is elimi-nated from the infusion set before administrationstarts.

SECTION 9

51

PRIMING


The priming function is used for filling the infu-sion set with drug from the syringe. A total of1.5 ml, in steps of 0.5 ml, can be primed usingthe priming function.

Priming can only take place when the pusheris in the starting position for a new, full or par-tial volume, infusion. If another priming isnecessary during an ongoing infusion, the cli-nician bolus can be used.

The catheter can always be primed manuallyby removing the syringe and pressing the rub-ber stopper forward, but it is not recommen-ded to teach patients this procedure as thisnullifies the purpose of using the priming func-tion as a bolus function.The prime function is available at all three locklevels.

Priming procedure:

1. Depress the button when the pump is inOFF.

2. The display shows Pr. There are three dif-ferent alternatives to choose from:

a. To postpone primingb. To skip primingc. To start priming

a. To postpone priming

Depress the button and the buttonsimultaneously; the pump will switch to OFF;or wait 10 seconds and the pump will automa-

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SECTION 9


tically switch to OFF.

b. To skip priming

Depress the button; the pump will start theinfusion and the display will show the remai-ning infusion time.

c. To start priming

Depress the button: the pump will deliver0,5 ml and the display will show a P followedby the volume in ml that has been primed.After the first priming of 0.5 ml, the display willshow Pr again and the procedure can berepeated two more times up to 1,5 ml hasbeen primed. There is no time limit to finish the priming pro-cedure.

NOTE

• If no button is pressed for 10 seconds in Pr,the pump will switch to OFF.

• The priming volume is neither included in the administration volume nor included in the calculation of remaining infusion time.

• The priming can be interrupted at any timeby depressing the button and the but-ton simultaneously. The display will show Pr and alternative a, b or c can be selec-ted again.

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SECTION 9

53

PUMP IN ON (RUNNING)


The remaining infusion time is displayed inhours and minutes when the pump is in ON(running).

The letter h flashes when the remaining infu-sion time is displayed in hours.

The symbol “mins” flashes when the remai-ning infusion time is displayed in minutes.

When the flow rate is programmed to 0,00,only patient and clinician boluses will be deli-vered and the display will show F0,00 with theF flashing.

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SECTION 9

54

BOLUS DOSE


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The bolus dose is used by the patient to admi-nister an additional dose of medication asneeded.If the bolus dose is programmed to 0 ml, nobolus dose can be administered.

Delivering a bolus doseBolus doses can only be delivered when thepump is in ON (running).

1. Depress the button and the pump will emit an acoustic signal, which indica-tes that the pump starts to deliver the pro-grammed bolus dose. The display will show a flashing d followed by the current volume in ml being delivered. For every 0,10 ml being delivered, the pump emits an acoustic signal, makes a pause of 2 seconds and continues to deliver the next0,10 ml of the programmed bolus dose.

2. When the delivery of the bolus dose is completed, the pump will emit an acousticsignal and the remaining infusion time willbe displayed. If the flow rate is program -med to 0,00 ml, F0,00 will be displayed instead of remaining infusion time.

NOTE

• By depressing the and the buttons simultaneously, the bolus dose delivery canbe interrupted at any time.

• If the bolus dose is programmed to 0,00 andthe button is depressed in ON, the errormessage Er,d, will be displayed.

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SECTION 9

55

BOLUS DOSE LIMITATIONS


• Time interval between bolus doses(t limitation)

• Number of bolus doses per hours(n limitation)

Bolus doses cannot be delivered during thelock-out time (t) or when the number of pro-grammed boluses per hour (n) already hasbeen administered.

The pump will always choose the program-med (t) or (n) that administer the lowestamount of bolus doses in ml.

If a bolus dose is requested during limitationtime (t) or after the maximum number of bolusdoses (n) has been reached, the display willshow error message Er,t and Er,n respecti-vely.

SECTION 9

56

CLINICIAN BOLUS


The access to the clinical bolus function is reserved to physicians or para-medic staff.

SECTION 9

57

OCCLUSION OF INFUSION SET


The pump has been designed to recognisewhen the drug delivery is interrupted by exter-nal circumstances such as involuntary kink ofthe infusion set tubing. In this case the pumpstops running the infusion, the display willshow the symbol for occlusion and the pumpwill emit an acoustic signal every 10 seconds.Drug administration is interrupted as long asthe occlusion remains. Find and remove thereason for the occlusion and press thereafterthe button to silence the acoustic signal.

NOTE• Search for the occlusion along the infusion set

and in the connection point of the set to the patient.

• It is recommended to use kink-free infusionsets to prevent or reduce occlusions to occur.

When the occlusion alarm signal is triggered,the pump has built up a certain overpressurein the administration line(s), which has to beeliminated to avoid an accidental post occlu-sion bolus that could result in serious injury ordeath of the patient.

The size of a post-occlusion bolus for CronoPCA 50 in combination with an infusion setwith 27G needle, 80 cm lenght with very stifflining is about 1.5 ml.

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POST OCCLUSION BOLUSWARNINGS

The size of a post-occlusionbolus can increase, if thereis air in the line, when othercatheter sizes, filters andextension set tubings withsofter materials are used, orwhen the lines from thepump are connected to otheraccess devices.After an occlusion signal useappropriate precaution withthe aim to avoid the admini-stration of a post-occlusionbolus to the patient.

CAUTIONSDisconnect the infusionset from the patient or puta clamp on the infusionset before starting thereversal of the pusher toavoid that medication isaspirated from the infu-sion set.

SECTION 9

58

END OF INFUSION


Ten and five minutes before the end of infu-sion, the pump will emit an intermittent acou-stic signal lasting two seconds per signal.

At the end of infusion, the pump will emit acontinuous acoustic signal and END will bedisplayed.

By depressing the and the buttonssimultaneously, the acoustic message will besilenced and the pusher will move back to thestarting position.

NOTE• The reversal for a 50 cc volume lasts about

6 minutes; the duration is proportionally shorter for lower volumes.

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SECTION 9

59

REVERSALS OF THE PUMP PUSHER


Reversal of pusher before the end ofinfusion.It is possible to interrupt an infusion in pro-gress and reverse the pusher to its startingposition:

• Depress the and the buttons simul-taneously to switch off the pump.

• Depress the and the buttons simul-taneously, End will be displayed for about 10 seconds and the pump will start to rever-se the pusher.

• The reversal request of the pusher can be cleared/canceled by depressing the and

button simultaneously during the 10 seconds the screen is displaying End.

Reversal of pusher at the end of infu-sion.The pump will emit an acoustic signal at theend of infusion and End will be displayed.Depress the and the buttons simulta-neously and the pusher will revert to the infu-sion starting position.

Pump pusher movementWhen the pump pusher reverses with a conti-nuous movement, a symbol depicting move-ment will be displayed.

NOTE• The reversal of the pusher before the end of

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CAUTIONS• Disconnect the infusion

set from the patient or put a clamp on the infu-sion set before starting the reversal of the pus-her to avoid that medi-cation is aspirated fromthe infusion set.

• Do not remove the reservoir before the pusher has reached thestarting position for a new infusion.

SECTION 9


infusion can be interrupted by depressing the and the buttons simultaneously;OFF will be displayed.

• If pump reversal is requested when the pusher already is in the starting position foran infusion, the pump will emit an acoustic signal and Err will be displayed

• The reversal of the pusher at the end of infusion can be interrupted by depressing the and the buttons simultaneously;End and OFF will alternate on the screen. By depressing the button, the pump willresume the reversal of the pusher.

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SECTION 9

61

SWITCHING OFF THE PUMP


Depress the and buttons simulta-neously. The display will show OFF.

If the pump is switched OFF while an infusionis ongoing the device will emit a sequence of 5short sounds every 5 seconds and OFF willflash on the display. To silence the acousticalarm press down the button for 7 seconds.

Such a condition will be repeated any time thedevice is switched OFF while an infusion is inprogress.

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SECTION 10

62

DISPLAYING PROGRAMMED PARAMETERS


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To display programmed parameters/valuesthe pump must be running (ON). The screenwill show either remaining delivery time orF0,00 if the flow rate is programmed to 0.

Display procedure:

1. Depress the button for about 1 second and the programmed flow rate will be dis-played.

2. If no button is depressed for 5 seconds, thepump will revert to remaining delivery time or F0,00.

3. If the button is depressed again within the 5 seconds time interval, the next value of the programming phase will be displayedand so on. The sequence is as follows: bolus dose, minimum interval between bolus doses, number of bolus doses per hour, partial volume, clinician bolus.

NOTEThe lock level of the key pad does not interfe-re with programmed parameters.

The chart beside explains the sequence ofscreens related to the display of the parame-ters.

SECTION 10


+

+

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+

+

+

+

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20

Flow rate

Bolus dose

Minimum time interval between bolus doses

Number of bolus doses perhour

Partial volume

Clinician bolus

The screens above are examples of what can be displayed.

Remaining delivery time

SECTION 10

64

DISPLAYING DELIVERED VOLUMES


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This display procedure will show the deliveredvolume in ml since the start of the infusion forthe different delivery options. The pump has to be running (ON) and thescreen will either show the remaining deliverytime or F0,00.

Display procedure:1. Depress the button for about 1 second

and the programmed flow rate will be displayed.

2. If no button is depressed for 5 seconds, thepump will revert to remaining delivery time or F0,00.

3.If the button is depressed again within the 5 second time interval, the next value will be displayed as follows: Volume delive-red as bolus doses, Number of bolus doses delivered, Volume delivered as clinician boluses, Total volume delive-red.

NOTE• The lock level of the key-pad lock out does

not interfere with programmed values.

• The values of the volumes delivered are constantly updated during the infusion.

• All values related to delivered volume and number of bolus doses are automatically reset to zero at the beginning of a new or partial infusion.

The chart beside shows the sequence of thescreens related to the volumes delivered bythe pump during an infusion.

SECTION 10


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Volume delivered as flow rate duringthe infusion in progress.

Volume delivered as bolus dosesduring the infusion in progress.

Number of bolus doses already delive-red.

Volume delivered as clinician bolusesduring the infusion in progress.

Total volume delivered (flow rate +bolus doses + clinician bolus doses).

The screens above show examples of what can be displayed.

Remaining delivery time

WARNING

If the key pad lock-out isprogrammed to L1, clea-ring the number of bolusdoses delivered is notpossible. The display willshow L1, indicating thatlocked out programmingfunctions cannot bereprogrammed in lock-outlevel L1.

SECTION 10

66

CLEARING THE NUMBER OF BOLUS DOSES DELIVERED


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The number of bolus doses delivered can beset to zero at any time, provided that the locklevel is L0.

Clearing procedure:1. Depress the and the buttons simul-

taneously for about 4 seconds with the pump in OFF and the number of bolus doses delivered will start flashing on the screen.

2. Depress the button within 7 seconds, the pump will emit an acoustic signal and the number of the bolus doses delivered willbe set to zero and OFF will be displayed.

SECTION 10

67

DISPLAYING THE NUMBER OF COMPLETE INFUSIONS


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The pump has to be in OFF to be able to dis-play the number of complete infusions perfor-med by the pump.

Depress the button for about 7 secondsand the number of complete infusions will bedisplayed.

Clearing the number of complete infusionsperformed by the pump.

Clearing procedure:1. The pump has to be in OFF and lock level

L0.

2. Depress the button for about 7 secondsand the number of complete infusions will be displayed.

3. Without releasing the button, depressthe button as well and the number of complete infusions will start flashing on thescreen.

4. Depress the button for about 1 second and thereafter the button for about 1 second (in sequence) and the button within 7 seconds. The pump will emit a tic-king sound followed by a longer signal. Thenumber of complete infusions will flash on the screen for 7 seconds, which is the timeinterval that is available to depress the button, which completes the clearingprocedure.

WARNING

If the key-pad lock level isin L1 when the clearingsequence is started to beperformed, the pump willemit an acoustic signaland L1 will be displayed.

SECTION 10


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5. If the clearing sequence is correctly perfor-med, the message 0000 will appear on thescreen for about 3 seconds followed by thesound of the buzzer. If not, or if no buttons are depressed for more than 7 seconds, the message UNDOwill appear on the screen ( operation not performed correctly).

6. OFF will be displayed at the end of zero setting.

CAUTIONS

• Avoid that the pump stops during an ongoinginfusion by changing thebattery as soon as the LOW BATTERY symbol appears and the ongoinginfusion is completed.

• Do not replace the battery:- during an ongoing

infusion. - when the infusion set

is connected to the patient.

SECTION 11

69

LOW BATTERY ALERT


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The LOW BATTERY symbol will be conti-nuously displayed when the battery level islow.The battery should be changed as soon as theongoing infusion is completed.

If the battery is completely discharged, BAT-TERY DISCHARGED, the symbol batt will bedisplayed and the pump will emit a short acou-stic signal. The pump will stop and the infusioncannot be completed without changing bat-tery.

SECTION 11


BATTERY INSTALLATION OR REPLACEMENT

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Use only lithium 3 Volt 123 A batteries.Make sure the pump is in OFF condition (OFFwill be displayed), then replace the battery.

Battery exchange procedure:

1. Open the battery compartment using the blue key-ring device that is included with the pump.

2. Pull out the cover.

3. Use the small ribbon strap (which lies underthe battery) to facilitate the removal of the battery.

4. Remove the discharged battery and discardit properly.

5. Wait for 10 seconds, then insert the new battery checking that it is placed in the cor-rect position as to polarity indicator and thatthe ribbon strap is under the battery.

6. Close the cover after the battery has been installed.

CR

ON

O P

ID

CR

ON

O P

ID

CRONO PID

CRONO PID

CR

ON

O P

ID

CR

ON

O P

ID

CRONO PID

CRONO PID

CR

ON

O P

ID

CR

ON

O P

ID

CRONO PID

CRONO PID

CR

ON

O P

ID

CR

ON

O P

ID

CRONO PID

CRONO PID

CR

ON

O P

ID

CR

ON

O P

ID

CRONO PID

CRONO PID

CR

ON

O P

ID

CR

ON

O P

ID

CRONO PID

CRONO PID

WARNINGS

• Do not use rechargeablebatteries.

• The use of batteries of adifferent type could result in device malfunc-tions.

• Battery life will vary depending on the batteryage, temperature and storage conditions.

• Make sure that a new battery is kept available for emergency replace-ment.

• Do not store the pump forprolonged periods (1-2 months) with the batteryinstalled.

• Make sure that the bat-tery door is properly clo-sed.

• Dispose of used batteriesin an environmentally safe manner and accor-dingly to any regulationswhich may apply.

If it is difficult to remove the battery using theribbon strap, do not use any other object toremove the battery but try the following proce-dure:

• Hold the pump and the battery compart-ment firmly in your right hand.

• Tap your right hand on the palm of your lefthand until the battery falls out.

NOTE• When a battery is installed, the pump per-

forms a self-test during which all symbols will be displayed and the pump will emit acoustic signals.

• Under average operating conditions, each battery should last about three months or 80-100 infusions.

• The pump retains all programmed values. The data are not lost when the battery is replaced or removed or if the pump isn't used for prolonged periods. Programmed partial volume is the only programmed value that is not saved if the battery is removed.

The door is fitted with a silicone seal thatmust remain in its lodging as shown in figure.

Silicon seal

SECTION 11


SECTION 12

72

GENERAL CAUTIONS


The device may be damaged upon contact with any liquid, therefore remo-ve it before taking a bath or shower etc. Should the pump accidentally comeinto contact with any liquid (drug solution, sweat, bed wetting) the pump hasto be checked by CANÈ or CANÈ's local representative.

The pump must be kept away from:- heating devices (radiators, oven rings, stoves);- direct sunlight;- high electromagnetic fields (magnets, loud-speakers, portable radio devices), details are supplied on ANNEX 4;

- ionogenic radiations;- supersonant devices- magnetic resonance devices

The pump does not need to be sterilised.

Do not freeze the CRN syringe with the drug inside.

The pump must not be put in the fridge or in the freezer.

The pump must not be put in the oven or in the microwave oven.

Réservoirs, infusion sets, needles, filters and any disposables used duringthe infusion process must be properly discarded using the appropriate con-tainers.

The version and the publication date of the present manual are reported onall pages of the documents. If after one year from the date of publication andthe use of the pump, the physician should contact CANÈ S.p.A. or the localrepresentative with the aim to check if there is an updated version of theuser guide available.

USER GUIDE UPDATE

CAUTIONS• Do not dip the device into water

or detergent solutions.• Avoid the risk of liquid penetra-

tion inside the instrument. Should the device become wet, absorb the liquid with blot-ting paper.

• Do not clean the pump with acetone, solvents or abrasive detergents.

• Do not sterilise the pump.

SECTION 12

73

MAINTENANCE


CLEANING

Should the device be damaged, the pump has to be checked by CANÈ orCANÈ's local representative.CANÈ S.p.A. recommends an annual check up on all Crono PCA 50 pumpswith the aim of evaluating the correct function and accuracy. Such check upsmust be carried out only by CANÈ S.p.A. or an authorized distributors.

The exterior shell of the pump can becleaned with a soft cloth slightly moi-stened with a mild detergent.

If the pump is not going to be used for a long period of time (more than 1 or2 months), the battery should be removed and put inside the pump case,which should be stored in a dry place.

STORAGE

Accuracy and safe functioning of the pump are guaranteed for 4 yearsbeginning from the date of purchase.

PUMP LIFE

At the end of the period of pump life, contact CANÈ or CANÈ's local repre-sentative to get all the necessary information concerning the collection anddisposal of the pump.

DISPOSAL OF THE PUMP

The pump can only be repaired by CANÈ S.p.A. and the pump has the-refore to be sent to CANÈ's local representative in the country in whichthe pump has been sold for further transportation to CANÈ S.p.A.

Do not send any pumps for repair before you contact your local repre-sentative.

Your local representative is:

SECTION 12

74

USER INFORMATION


UNITED STATES:INTRA PUMP INFUSION SYSTEMS920 Minters Chapel Road, Suite 200Grapevine, Texas 76051Tel: 866-211-7867Fax: 630-845-2768Email: [email protected]

MANUFACTURER:CANÈ S.p.A. MEDICAL TECHNOLOGYVia Cuorgnè, 42/a Rivoli (TORINO) ItalyTel: 0039-011-9574872Fax: 0039-011-9598880Email: [email protected]

SECTION 13

75

MANUFACTURER’S GUARANTEE


With this consumer guarantee, CANÈ S.p.A. guarantees that this product isfree from defects in materials and workmanship for a period of 2 (TWO)YEARS beginning from the date of purchase.

If during this period of guarantee the product proves defective due to impro-per materials or workmanship, CANÈ S.p.A. will without charge for labour orparts, repair or replace the defective parts upon the terms and conditions setout below.

CANÈ S.p.A. reserves the right to modify the characteristics or the model ofthe pump and accessories without obligation to make similar modificationsto pumps and accessories previously manufactured or sold.

Conditions:

1. This guarantee will be granted only if the defect is brought to the atten-tion of CANÈ S.p.A.

2. This guarantee will not be in effect if the pump and accessories have been damaged as a result of modifications or adjustments made withoutprior written consent from CANÈ S.p.A.

3. This guarantee will not apply if the type or serial number on the product has been altered, deleted, removed or made illegible.

4. This guarantee does not cover any of the following: • Periodic maintenance.• Damage resulting from misuse, including but not limited to:

- Failure to use the product for its normal purpose or in accordancewith this user’s guide;

- Repair done by non-authorised Service Stations or Dealers, or the Customer himself;

- Accidental events, dropping, liquid infiltration.• Natural calamity, fraudulent or premeditated action.

SECTION 13


5. CANÈ S.p.A. will aim to carry out repairs to the device over a period notin excess of 4 (FOUR) years, from the date of purchase. After 4 years, CANÈ S.p.A. will no longer be obliged to make any repairs.CANÈ S.p.A. is not responsible towards the purchaser or third parties forany damage deriving from the use of the pump after 4 (FOUR) years asfrom the date of purchase.

6. Once the warranty period has expired, CANÈ S.p.A. will provide the service charging the costs of components being replaced, expenses of labour charges and freight charges.

SECTION 14

77

ALARM MESSAGES


Unfeasable operation

INFUSIONS

Incorrect reset

Continuous acoustic signalRestart device

Irregularity in the security system

Continuous acoustic signal

Irregularity in the motor circuit

Acoustic signal repeated every 10 seconds

1. Remove the cause

2. Restart device

Irregularity of the pusher advancement


Occlusion, pump stopped.


Reading memory error (EEPROM)

Intermittent continuous acoustic signalRestart device*

Restart deviceError within the motor piloting circuit

Intermittent continuous acoustic signal

---------------

Press the button

Press the button

Press the button

Remove occlusion.Press the button

CODE DESCRIPTION/ACOUSTIC SIGNAL ACTION

Mechanical block during “End” phasecaused by foreign matter obstructing

the pusher’s reversal

7 beeps followed by another 7 beeps after 1 and 2 minutes

10

10

20

10

20

10

20

10

20

10

20

10

20

10

20

10

20

Active limitation of bolusdoses number (not possible

to deliver bolus doses)Refer to user guide

at page 5510

20

Refer to user guideat page 54

10

20

Refer to user guideat page 55

10

20

Bolus dose not available (value set for bolus dose is 0)

Active limitation of interval bet-ween bolus doses (not possible

to deliver bolus doses)

10

20Keypad locked Unlock the keypad

Alarm messages are accompanied by audible signals.Re-startTo re-start the device following an alarm message, remove the battery and wait at least 10 seconds before re-inserting it.

*WarningAfter Er,8 signalling, and the subsequent initialization, the standard para-meters would be the factory ones (see page 16). Therefore, should thiscondition take place, you need to re-program the parameters assigned bythe physician.The parameters programmed by the physician have to be recorded on thenote-page (see page 86).

SECTION 14


INFUSIONSCODE DESCRIPTION ACTION

SECTION 14

79

SHORT INSTRUCTIONS


10

20

10

20

10

20

10

20

PUMP ACTIVATIONBUTTONS

• The screen will show all symbols.

• Piston self-adjust.

• Pump switches OFF.

10

20

10

20

10

20

PU

MP

OF

F

• Reversing of the pump piston to the start position.

• Reading the number of infusions delivered.

• Reset the number of bolus delivered (L0).

• Confirm the reset of bolus delivered.

• Pump switches ON.

and

and

depress simultaneously


depressed for 8 seconds

PUMP ON

SCREEN

BUTTONS SCREEN

INS

ER

TIN

G B

AT

TE

RY

REVERSING OF THE PUMP PISTONNUMBER OF INFUSIONS DELIVERED

SECTION 14

80

Priming possible: only at strat of a new infusion or start of a new partial infusion.

• Access to PRIME phase.

• PRIME (each depressing administers 0.5 ml - max 1.5 ml).

• PRIME phase finish, infusion start.

• PRIME interruption (if in execution).

• Device switch OFF (if PRIME carried out).

In case there is a need to prime one or more times during an

already started infusion, the clinician bolus can be used

PRIME

10

20

10

20

10

20

10

20

10

20

10

20

10

20

10

20

10

20

10

20

SETTINGS

PU

MP

OF

FP

RIM

E C

ON

DIT

ION

Operations feasible only with key-pad unlocked.

• Setting flow (from 0.05 to 35 ml/h with the following

increments:- from 0.05 to 10 with 0.02 ml increments; - from 10

to 35 with 0.05 ml increments).

• Setting bolus dose (from 0.10 to 9.98 ml with 0.02 ml

increments).

• Setting bolus time limitations (- from 5’ to 1 h with

increments of 5’ - from 1 h to 24 h with increments of 15’).

• Setting boluses number limitations (0-12 per h).

Bolus lock-out possibilities: combination of bolus time and

bolus number limitations. The computer always chooses the

programming that results in the smallest bolus volume.

• Setting partial volume (from 1 to 50 ml with

increments of 1 ml - possible only at the begin of a new

infusion).

• Decrease/Increase above parameters.

1st depressing

2nd depressing

3rd depressing

4th depressing

5th depressing

/

and

and



BUTTONS SCREEN

BUTTONS SCREEN


SECTION 14


PU

MP

ON

• Bolus dose delivery.

• Bolus interruption (if in execution).

INFUSIONS

10

20

anddepress simultaneously

ON

10

20

10

20

10

20

10

20

1st depressing

2nd depressing

3rd depressing

4th depressing

5th depressing

ON

• Programmed flow rate.

• Programmed bolus dose.

• Programmed bolus time limit.

• Programmed bolus number limit.

• Programmed partial volume.

• Programmed clinician bolus dose.

10

20

10

20

10

20

10

20

10

20

10

20

• Administered flow rate in ml since start ofinfusion.

• Administered patient bolus in ml since start of infusion.

• Administered number of bolus.

• Administered clinician bolus in ml since start ofinfusion.

• Total administered volume in ml since start of infusion.

10

20

BUTTONS SCREEN

SCREEN REVIEW OPTIONSBUTTONS SCREEN

SCREEN REVIEW OPTIONSBUTTONS SCREEN

1st depressing

2nd depressing

3rd depressing

6th depressing

4th depressing

5th depressing

SECTION 14


PU

MP

ON

10

20

EN

D O

F

INF

US

ION

10

20

10

20

10

20

PUMP OFFBUTTONS SCREEN

END OF INFUSIONBUTTONS SCREEN

• Pump switches OFF.anddepress simultaneously

and

• End of infusion.

• Piston automatic reversing.

• Automatic switch OFF.depress simultaneously

SECTION 15

83

PUMP ICON TABLE


Drip-proof instrumentIt can withstand occasional liquid dripping orsplashing.It must not be immersed in liquid.

CE Mark

Electromedical equipmentBF type

Warning: see instructions for use

Pump serial number

Dispose of used electric and electronicdevices in an environmentally safe manner,using the appropriate containers and accor-

ding to any regulations that may apply.

SN

0476

SECTION 15

84

RÉSERVOIR BLISTER PACKAGE ICON TABLE


CE mark

Recyclable

Do not re-use

Expiration date

Sterilised by Ethylene oxide

Polypropylene

Lot number

0123

2

LOT

STERILE EO

PP

SECTION 16

85

STATEMENT OF CONFORMITY


0476CANÈ S.p.A. is a registered company with its headquarters in ViaCuorgnè 42/a 10098 Rivoli (TO) Italy. CANÈ S.p.A. is the manufacturerof the portable, electrically-operated ambulatory infusion pump CronoPCA 50.

CANÈ S.p.A. declares that this product conforms to the safety provisionsas set out in Annex II, risk class IIb, following the directive 93/42/EECdated 14 June 1993 as certification N. MED-9813 issued by NotifiedBody 0476.

Serial numberManufacturing date

SECTION 16

86

NOTE


SECTION 17

87

GLOSSARY


AlarmAn alarm is a condition that warrants the user’s attention, and is criticalenough that it requires that the pump be shut down or reset.When an alarm occurs, an alarm beep is sounded and a descriptive mes-sage appears on the display screen.

BolusA bolus dose is an additional quantity of drug that can be released undercertain defined conditions

Basal flow rateThe basal flow rate is the quantity of drug delivered by the pump in a timeunit.

Clinician bolusA clinician bolus is an additional quantity of drug that can be released by aphysician or other authorized health care staff and which overrides otherprogrammed bolus restrictions.

Display screenThe pump’s liquid crystal display screen is located on the front panel of thepump, providing the information about the functioning of the pump.

Electromedical equipment BF typeElectromedical equipment manufactured with particular accuracy and careas regards to security. The equipment is suitable for ambulatory use inwhich the patient can wear the equipment/pump in close contact with thebody without influencing the functions of the equipment/pump.

Free FlowDrug is leaving the reservoir in an uncontrolled way due to the force of gra-vity.

SECTION 17

88

Luer-lock connectorA luer-lock connector is a special threaded fitting used to connect the infu-sion set to the réservoir.

Luer-lock connector female/femaleThe luer-lock connector female/female connects the réservoir to the stan-dard syringe.

Occlusion pressureAn alarm beeps when occlusion pressure is reached.

Pyrogen freeIt means that the syringe does not contain pyrogenic substances, whichcause fever as the ones released, for instance, by leucocytes or producedby bacteria.


ANNEX 1

89

ACCURACY TESTS


The tests have been carried out in compliance with the standard IEC 60601-2-24, Medical electrical equipment – Part 2-24: Particular requirements forthe safety of infusion and controllers. The following graphics show the accu-racy of the pump during the administration.

1.1 - Start-up flow rate• Programmed flow rate: 1 ml/h

Crono PCA 50 - F: 1 ml/h


1.2 - Flow rate error (trumpet curve)• Programmed flow rate: 1 ml/h• Average error: +/- 3%

Accuracy may deviate from the information in this user guide depending onwhich type of extension sets, tubings and access devices that are used forthe administration of a medication.

ANNEX 2

91

TIME TO AN OCCLUSION ALARM SIGNAL


There is a certain interval time between an occlusion occurs and the time ittakes for the pressure in the administration line to trigger the occlusionalarm signal. The table below is showing the time to an occlusion alarm withdifferent flow rates in combination with an infusion set with 27G needle, 80cm lenght with very stiff lining.

The time to the occlusion signal is a function of the flow rate, the lower theflow rate, the more time the pump will need to trigger the occlusion alarm.

CAUTIONThe time to an occlusion alarm signal can increase if there is air in the line,when other catheter sizes, filters and extension set tubings with softermaterials are used, or when the lines from the pump are connected to otheraccess devices.

For patients that are likely to be adversely affected by interrupted medica-tion or fluid delivery from Crono PCA 50, close supervision for immediatecorrective action should be provided.

Flow rate Time to a occlusion alarm signal

0.1 ml/h About 16 hours

1 ml/h About 1 hour and 30 minutes10 ml/h About 9 minutes

ANNEX 3

92

POST-OCCLUSION BOLUS


When the occlusion alarm signal is triggered, the pump has built up a cer-tain overpressure in the administration line(s), which has to be eliminated toavoid an accidental post occlusion bolus that could result in serious injury ordeath to the patient. The size of a post-occlusion bolus for Crono PCA 50 incombination with an infusion set with 27G needle, 80 cm lenght with verystiff lining is about 1.5 ml.

Post-occlusion bolus may deviate from the information in this user guidedepending on which type of extension sets, tubings and access devices thatare used for the administration of a medication.

CAUTIONThe size of a post-occlusion bolus can increase if there is air in the line,when other catheter sizes, filters and extension set tubings with softer mate-rials are used, or when the lines from the pump are connected to otheraccess devices.

Patients, who are likely to be adversely affected (serious injury or death) byan accidental release of the post-occlusion bolus, should not eliminate thebolus before having instructions how to do the elimination correctly or betrained to eliminate the post-occlusion bolus correctly themselves before thedrug delivery is resumed.

ANNEX 4

93

ELECTROMAGNETIC COMPATIBILITY


The tests have been carried out in compliance with the standard IEC 60601-2-24, Medical electrical equipment - Part 2-24: Particular requirement for thesafety of infusion pump and controllers.

4.1 – Emission testsThe test has been executed with the antenna in horizontal and vertical pola-rization.

4.1.1

4.1.2 - ResultNo degradation of performance or loss of function is allowed during the test.

4.2 - Electrostatic DischargeDischarges in air have been carried out in proximity of the push-buttons, inproximity of two angles of the display and two angles of the battery com-partment.Contact discharges have been carried out on the two eyelets and two pointsof the anodized metallic body.

4.2.1


TEST Coupling port Range frequencyRadiated emission Enclosure 30 - 1000 MHz

TEST Coupling port Test level

ElectrostaticDischarge

Enclosure15 kV air discharge, 8 kVcontact discharge, pos.

and neg.


4.3 - Radiated immunity

The A test has been executed with horizontal and vertical field polarization.

The B test has been executed with horizontal and vertical field polarization,with steps of equal frequency to 1% of the fundamental one.

4.3.1


TEST Coupling port Frequency range Test level

A - Radiatedimmunity

Enclosure 26-80 MHz10 V/m 80% AM

1kHz

B - Radiatedimmunity

Enclosure 80-1000 MHz10 V/m 80% AM

1kHz

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