Crono PCA 50 Patient User Guide Firmware PD.02.03 April 2010

PATIENT USER GUIDE

CANÈ S.p.A. Medical Technology Via Cuorgnè 42/a 10098 Rivoli (TO) Italy Tel.+39 011 9574872 - Fax +39 011 9598880 www.canespa.it - [email protected]

Manual code: MAN 01/06/USA/p CRONO PCA 50 04/10 Firmware version: PD.02.03 Data firmware: 04/07/07

TABLE OF CONTENTS

SECTION 1 Introduction...page 9 Warnings...page 9 Note...page 12 Intended Use...page 12 Information-Technical assistance...page 12 SECTION 2 Description of the pump...page 13 Infusion system...page 14 Technical features...page 14 Factory settings...page 16 SECTION 3 Standard equipment supplied...page 17 Optional accessories...page 18 How to use the standard equipment supplied...page 20 How to wear the pump...page 22 SECTION 4 Pump overview...page 23 Liquid crystal display...page 25 Main screen indications...page 25 Key-pad...page 27 SECTION 5 Identification of the reservoir parts...page 28 Luer-lock cap...page 29 Profill-crn needle...page 29 Filtrajet...page 30 Infusion set...page 30 Preparation for infusion...page 30 Anti-Siphon valve...page 31 Réservoir preparation...page 32 Connecting the réservoir to the pump...page 34 Safety system to avoid free-flow...page 35 Warning safety system to avoid free-flow...page 36 5

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SECTION 6 Device activation...page 37 SECTION 7 Key-pad lock out...page 38 Table of key-pad lock-out levels...page 39 SECTION 8 Programming...page 40 Programming of flow rate...page 42 Programming of bolus dose...page 43 Minimum interval time between bolus doses...page 44 Programming of bolus doses per hour...page 46 Programming of partial volume...page 48 SECTION 9 Starting the pump...page 50 Priming...page 51 Pump in on (running)...page 53 Bolus dose...page 54 Bolus dose limitations...page 55 Clinician bolus...page 56 Occlusion of infusion set...page 57 Post occlusion bolus...page 57 End of infusion...page 58 Reversal of the pump pusher...page 59 Switching off the pump...page 61 SECTION 10 Displaying programmed parameters...page 62 Displaying deliverd volumes...page 64 Clearing the number of bolus doses delivered...page 66 Displaying the number of complete infusions...page 67 SECTION 11 Low battery alert...page 69 MAN 01/06/USA/p CRONO PCA 50 04.10

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Battery installation or replacement...page 70 SECTION 12 General cautions...page 72 User guide update...page 72 Maintenance...page 73 Cleaning...page 73 Storage...page 73 Expected life of the pump...page 73 Disposal of the pump...page 73 User information...page 74 SECTION 13 Manufacturer’s guarantee...page 75 SECTION 14 Alarm message...page 77 Short instruction...page 79 SECTION 15 Pump icon table...page 83 Réservoir blister package icon table...page 84 SECTION 16 Statement of conformity...page 85 Note...page 86 SECTION 17 Glossary...page 87 ANNEX Annex 1...page 89 Annex 2...page 91 Annex 3...page 92 Annex 4...page 94 7

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

SECTION 1 INTRODUCTION

CAUTION: US Federal law restricts this device for sale by or on order of a physician. The instructions included in this manual are intended only for the ambulatory drug infusion pump CRONO PCA 50 and are addressed to the pump user. The pump is provided with key-pad lock-out in order to avoid accidental or non authorised variations of the selected parameters.

The information as to lock or unlock the key-pad are exclusively addressed to the physician. When the key-pad is locked any attempt to modify the protected parameters will cause the indication Lo,1 to appear on the screen. WARNINGS

Do not use the Crono PCA 50 without first reading and understanding the complete pump user guide. Improper programming and/or incomplete understanding of the operating functions and of the warnings could 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 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. 9

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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 drug administration. 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. 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). 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. 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 MAN 01/06/USA/p CRONO PCA 50 04.10

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SECTION 1

cause serious damage to the pumps’ electronic circuits.

Epidural drug infusions delivering drugs different from the ones specifically indicated for those kinds of administrations can cause serious lesions or death. CANÈ S.p.A. recommends an annual check up on all Crono PCA 50 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.

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SECTION 1 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

The ambulatory infusion pump of drug Crono PCA 50 has been designed to be used in the pain treatment for subcutaneous, intravenous and epidural infusions. The pump is not designed for life sustaining treatments. INFORMATION – TECHNICAL ASSISTANCE

For further information, technical assistance or if you have questions concerning the operation of the pump, please contact: UNITED STATES: INTRA PUMP INFUSION SYSTEMS 920 Minters Chapel Road, Suite 200 Grapevine, Texas 76051 Tel: 866-211-7867 Fax: 630-845-2768 Email: [email protected] MANUFACTURER: CANÈ S.p.A. MEDICAL TECHNOLOGY Via Cuorgnè, 42/a Rivoli (TORINO) Italy Tel: 0039-011-9574872 Fax: 0039-011-9598880 Email: [email protected]

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SECTION 2 DESCRIPTION OF THE PUMP

Crono PCA 50 is a new, innovative PCA pump that is very appreciated by health care professionals and patients due to its small size, 50 ml reservoir and convenience to use and operate. Crono PCA 50 is an ambulatory infusion pump especially suited 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 4 different administration modalities: 1. Continuous 2. 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.

Clinician Bolus

Bolus dose upon request

Bolus dose upon request

Clinician Bolus

ml

Continuous

t

The pump is provided with key-pad lock-out functions in order to avoid unauthorized reprogramming of the drug administration protocol. The liquid crystal display (LCD) shows the information which are helpful both for the clinician and the patient like programming, reading of administered drug volumes and control functions of the pump. 13

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SECTION 2 INFUSION SYSTEM

The pump administers shots of 20 µl for any given flow rate. The time interval between shots decrease proportionally to increases in programmed flow rates. Pump size

TECHNICAL FEATURES

Weight

Battery Réservoir

Administration volumes Priming Flow rate

Bolus dose Clinician bolus

84.5 x 55 x 42 mm.

140 g (battery included).

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

50 ml dedicated with luer-lock connector

From 1 ml to 50 ml with increments of 1 ml. Available only at the beginning of an infusion or partial infusion. The maximum deliverable volume is 1.5 ml with 0.5 ml increments. 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.

Programmable from 0.10 to 9.98 ml with 0.02 ml increments: The bolus dose can be programmed to 0 ml. 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. MAN 01/06/USA/p CRONO PCA 50 04.10

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SECTION 2

Number of boluses doses per hour Flow accuracy

Max. occlusion pressure

- from 1 to 12 boluses. - this function can be deactivated by programming 0.

+/-3% (observation period 40 minutes). 2.2 bar +/-0.8.

Time to an occlusion alarm

Please, see ANNEX 2.

Electric circuit

Electric circuit managed by a micro controller equipped with a dedicated software.

Post-occlusion bolus

Data storage Display Motor

Safety circuits Anti free-flow system Operating conditions Storage conditions

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About 1.5 ml (details are supplied on ANNEX 3).

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

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

To monitor the correct working of the device intervening in case of anomalies with acoustic warnings and error messages.

To avoid a non controlled flow inside the delivery set due to the force of gravity. +10°C / +45 °C 30% / 75% RH 700 hPa / 1060 hPa -10°C / +60 °C 10% / 100% RH 500 hPa / 1060 hPa

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SECTION 2 FACTORY SETTINGS

The following factory settings are programmed at the delivery of the pump: Key-pad lock-out level

L0

Flow rate

0.80 ml/h

Bolus dose

0.20 ml

Interval between bolus doses

1h

Number of bolus doses in 1 hour

1

Volume

50 ml

Clinician Bolus

c0.00 ml

Number of infusions

0

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SECTION 3 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).

2

3

1

8

6

5

4

7

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SECTION 3 OPTIONAL ACCESSORIES

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

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SECTION 3

2. Horizontal leather holder similar to a spectacle case.

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SECTION 3

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

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SECTION 3 HOW TO USE THE STANDARD EQUIPMENT SUPPLIED

The following illustrations show how the pump and its accessories can be set up. How to attach collar strap to the pump and the fabric holder.

10 20 30 40 50 l

m

How to use elastic belt with pump and fabric holder.

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SECTION 3 HOW TO WEAR THE PUMP

The following pictures show the various ways the pump can be worn.

Wearing the pump around the neck. 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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