Crono PCA User Guide Firmware ver P2.02.02 Jan 2009 Uncontrolled Copy

TABLE OF CONTENTS SECTION 1 Introduction... page 7 Warnings... page 7 Note... page 9 Intended use... page 9 Information... page 9

SECTION 2

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Pump description... page 10 Infusion System... page 10 Factory settings... page 10 Technical features... page 11

SECTION 3

Standard equipment supplied... page 12 Optional accessories... page 13

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SECTION 4

How to use standard equipment supplied... page 14 How to wear the pump... page 15

SECTION 5

Pump parts... page 16 Liquid Crystal Display (LCD)... page 17 Main screen indications... page 17

SECTION 6

SECTION 7

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Technical Features of the syringes... page 19 Luer Lock Cap... page 19 Filter... page 20 Filter parts... page 20 Preparation for infusion... page 21 Syringe preparation... page 22 Connection of the syringe to the pump... page 24 Safety system to avoid free-flow... page 25 Working instructions... page 26 Device activation... page 27

SECTION 8 Settings... page 28 Visualizing the setting parameters... page 35 Partial volume... page 38

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TABLE OF CONTENTS SECTION 9 Starting the pump... page 39 End of infusion... page 39 Filling up the tubing of the infusion set (Prime)... page 40 Occlusion of infusion set... page 41 Post-occlusion bolus... page 42 Switching off the pump... page 43 Reversal of the pump pusher... page 44 Pump pusher movement... page 45

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SECTION 10

Low battery alert... page 46 Battery replacement... page 46

SECTION 11

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Cautions... page 48 User guide update... page 49 Maintenance... page 49 Cleaning... page 49 Storage... page 49 Pump life... page 49 Disposal of the pump... page 49

SECTION 12

Technical service... page 50 Manufacturer’s guarantee... page 50

SECTION 13

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SECTION 14

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Alarm messages... page 52 Short instruction... page 53 Pump icon table... page 56 Syringe blister pakage icon table... page 57

SECTION 15

Glossary... page 58

SECTION 16 Statement of conformity... page 60

ANNEX Annex 1... page 61 Annex 2... page 63 Annex 3... page 64 Annex 4... page 65 6 MAN 01/I/05 CRONO PCA 01/09

SECTION 1 INTRODUCTION The instruction provided in this manual are intended for the prescribing physician which is responsable for the pump application. The instruction and details given here are fundamental for the correct and safe use of this device.

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Please take time to read all information before using the pump and keep this guide in a safe place for future reference. The pump is ready to use at delivery and does not require installation or other tests before being used on patients.

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WARNINGS

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Before using the pump for a specific infusion therapy check the suitability of the device for the use and for the patient considering carefully the 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, concerning the procedural clinical aspect whose responsibility is on the part of the doctor or the medical assistant. 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 drug administration.

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SECTION 2 Do not prime any kind of tubing when connected to a patient, as this could result in over-delivery of medication and air embolism. Eliminate all air bubbles in all lines before starting an infusion to avoid air embolism. Inspect the whole fluid path for kinks or closed clamps or any other obstruction before the infusion is started.

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Accuracy, time to an occlusion alarm signal and post-occlusion bolus size may deviate from the information in this user guide depending on which type of extension sets, tubing and access devices that are used for the administration of a medication (details are supplied on ANNEX 1, 2 and 3). For patients that are likely to be adversely affected by interrupted medication or fluid delivery from Crono PCA, close supervision for immediate corrective action should be provided. The improper connection between the syringe piston and the pump pusher can cause a free flow of medication, in other words, medication administered by gravity and not controlled by the pump, (for example when the pump is positioned much higher than the infusion site). Such situation can cause serious injury or death of the patient.

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If you know or suspect that the pump has been damaged in any way, for example through water or impact, please contact your local Customer Service representative to verify if the pump is operational. Do not use a pump that is damaged. Liquid on the outside of the pump should be wiped off immediately with a soft cloth. Please observe that any liquid penetrating the pump can cause serious damage to the pumps’ electronic circuits. CANÈ S.p.A. recommends an annual check up on all Crono PCA pumps with the aim of evaluating the correct function and accuracy. Such check ups must be carried out only by CANÈ S.p.A. or an authorized distributors. 8 MAN 01/I/05 CRONO PCA 01/09

SECTION 2 NOTE The manufacturer only takes the responsibility for the safety and reliability of this pump, provided that it is used in accordance with the current instructions for use and only in case any repairs and changes to the device are made exclusively by the manufacturer.

INTENDED USE

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The ambulatory infusion pump of drug Crono PCA has been designed to be used in the pain treatment for subcutaneous, intravenous and epidural infusions.

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Crono PCA pump must not be used in life sustaining treatment therapies.

INFORMATION

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

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• CANÈ S.p.A. On Line www.canespa.it E-mail: [email protected]

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• Customer Assistance Service CANÈ S.p.A. Medical Technology Via Pavia, 105/i 10090 Rivoli Cascine Vica (TORINO) Italy Tel. 0039.011.9574872 Fax 0039.011.9598880

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SECTION 2 PUMP DESCRIPTION Crono PCA is a new, innovative PCA pump that is very appreciated by health care professionals and patients due to its small size and convenience to use and operate. Crono PCA is an ambulatory infusion pump for controlled drug administration on patients in hospital or undergoing a therapy at home. The pump is suitable for subcutaneous, intravenous and epidural infusions allowing 3 different administration modalities:

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• Continuous • Bolus dose upon request (PCA) • Combined (continuous + bolus upon request)

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The pump is provided with key-pad lock-out functions in order to avoid unauthorized resetting of the drug administration protocol. The liquid crystal display (LCD) shows the information which are helpful both for the clinician and the patient like setting, reading of administered drug volumes and control functions of the pump.

INFUSION SYSTEM

FACTORY SETTINGS

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The pump administers shots of 22 µl for any given flow rate. The time interval between shots decrease proportionally to increases in programmed flow rates.

The following features were set at the factory but can be re-setting: Syringe

20 ml

Flow rate

0.80 ml/h

Bolus dose

0.50 ml

Interval between bolus doses

1h

Number of bolus doses in 24 hours

12

Number of infusions

0 10

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SECTION 2 TECHNICAL FEATURES 77 x 47 x 29 mm.

Weight

115 g (battery included).

Battery

CR 123A 3V Lithium battery (battery life: about 6 months).

Syringes Dedicated

10 and 20 ml capacity with luer-lock connector.

Administration volumes

Drug volume can be set from 1 ml to 20 ml with increments of 1 ml.

Flow rate

Programmable from 0.05 to 5.00 ml/h.

Bolus dose

Programmable from 0.02 to 0,99 ml with 0.022 ml increments.

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Pump size

Programmable from 5’ to 24 h.

Number of boluses administrable in 24 hours

From 1 to 24 boluses.

Flow rate accuracy

+/- 2%.

Max. occlusion pressure

2.6 bar +/-1.2.

Time to an occlusion alarm

Please, see ANNEX 2.

Post-occlusion bolus

About 0.4 ml (details are supplied on ANNEX 2).

Data storage

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

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Minimum interval time between bolus doses

Motor

DC coreless motor microprocessor controlled, equipped with optical encoder.

Safety circuits

Monitor the correct working of the device activating acoustic warnings and error messages.

Anti free-flow system

Avoid a non controlled flow inside the delivery set caused by gravity.

Key-pad lock-out functions

To avoid un-authorized resetting of the drug administration protocol.

Operating conditions

+10°C / +45 °C 30% / 75% RH 700 hPa / 1060 hPa

Storage conditions

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

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SECTION 3 STANDARD EQUIPMENT SUPPLIED

Fig.1

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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. User guide.

2

3

6

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1

4

5

8

7

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SECTION 3 OPTIONAL ACCESSORIES Optional accessories are available upon request: 1. Upright leather holder similar to a mobile telephone holder. 2. Horizontal leather holder similar to a spectacle case. Fig.2

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SECTION 4 HOW TO USE THE STANDARD EQUIPMENT SUPPLIED The following illustrations show how the pump and its accessories can be set up.

Fig.3

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

20 ml

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Fig.4

How to use elastic belt with pump and fabric holder

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SECTION 4 HOW TO WEAR THE PUMP The following pictures show the various ways the pump can be worn.

WEARING THE PUMP AROUND THE NECK

Fig.5

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Wearing the pump around the neck with a collar strap and a fabric holder.

WEARING THE PUMP AT THE WAIST Wearing the pump at the waist with an elastic belt and a fabric holder.

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SECTION 5 PUMP PARTS Fig.7

Syringe fin hook

Display

Pump piston

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Collar strap locking rings

d

-

+

Button

Button

Button

Battery compartment

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C Serial number

Brief instructions CE mark

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SECTION 5 LIQUID CRYSTAL DISPLAY (LCD) This is a screen on the front of the pump where symbols and messages are displayed informing the user about operations in progress as well as giving warnings and alarm messages. 10 20

10

“Low battery” symbol: appears when the battery charge is low (see page 46).

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20

“Drip” symbol: separates whole numbers from decimals.

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Symbol "10 ml": indicates the device has been set to use 10 ml (CRN 10) syringe setting.

20

Symbol "20 ml": indicates the device has been set to use 20 ml (CRN 10) syringe setting.

MAIN SCREEN INDICATION 10 20

10

10

10 20

10 20

PRIME EXECUTION FLOW RATE

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PRIME FUNCTION

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20

PUMP OFF

TIME LEFT TO END OF INFUSION (HOUR AND MINUTES)

10 20

BOLUS DOSE

10 20

TIME INTERVAL BETWEEN BOLUSES

10 20

NO TIME INTERVAL BETWEEN BOLUSES

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SECTION 6 TECHNICAL FEATURES OF THE SYRINGES The ambulatory infusion pump Crono PCA uses dedicated syringes: • CRN® 10 ml CRONO® Syringe. • CRN® 20 ml CRONO® Syringe.

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The syringes are: • sterile • single use only • pyrogen-free • to be used only if packaging is not damaged Syringe body

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Fig.8

Needle

Piston

Needle’s protection

Piston Rod

• It can be used after the syringe has been filled, in order to unscrew the plunger rod from the plunger with easy.

Fig.9

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LUER LOCK CAP

Luer-lock cap

• It can also works as drug protection in the syringe in case of not immediate use.

Luer-lock cap

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SECTION 6 FILTER It is advisable to use filters which: • Prevent possible infection from bacteria • Eliminate air in the syringe or the infusion set • Trap any fragments of glass or plastic

FILTER PARTS

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Fig.10

Male Luer Lock cap

Female Luer Lock cap

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Tube set @ 1 x 2,3 PVC-NO DOP

0,2 micron filter

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C Blue Male Luer Lock connector Female Luer Lock cap

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SECTION 6 PREPARATION FOR INFUSION Before the pump and other disposables are prepared to be used, it is advisible to follow these precautions to avoid any contamination: cr n

1. Wash your hands; min h

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OFF

d

O

CRON

0.2

ml

MICR

OJET

2. Prepare a clean working area.

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SECTION 6 SYRINGE PREPARATION 1. Attach the supplied needle to the syringe with a clockwise rotation; 2. Fill the syringe intaking the liquid slowly to avoid disconnection between the rubber piston and the stem verifying the drug inside does not exceed absolutely 10 or 20 ml capacity; 3. Attach luer-lock cap then unscrew the stem of the syringe counter-clock wise with a fairly swift movement; Fig.11

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1

2

3 22

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SECTION 6 4. Attach the syringe into the pump with 90° rotation, a click ensures it’s blocked (for details about the syringe connection to the pump see fig.12); 5. Attach the butterfly needle cone onto the syringe.

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5

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SECTION 6 CONNECTION OF THE SYRINGE TO THE PUMP WARNING It is important to fill up the syringe with the correct quantity of drug corresponding to 10 ml or 20 ml; if you do not take this advice the following conditions may occur:

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1. Syringe filled up beyond the nominal value. It is difficult or impossible to connect the syringe to the pump. While connecting the syringe to the pump an improper position of the piston inside the syringe may cause the leakage of the drug. 2. Syringe not completely filled up. The infusion will start when the device is activated, that is when the pump pusher moving forwards reaches the piston. In such a condition we do not guarantee the exact connection between the piston and the pump pusher.

Fig.12

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C Top view

1

2

3

4 24

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