Crono five Patient User Guide Firmware ver P2I.02.03 Nov 2010

PATIENT USER GUIDE

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

Manual code: MAN 01/06/USA/p CRONO Five 11/10 Date of publication: 10/08 Firmware version: P2I.02.03 Firmware date: 08/04/08

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 SECTION 4 Pump overview...page 21 Liquid crystal display...page 22 Main screen indications...page 23 Key-pad...page 25 SECTION 5 Syringe...page 26 Luer-lock cap...page 26 Filtrajet...page 27 Infusion set...page 28 Preparation for infusion...page 28 Syringe preparation...page 29 Connecting the syringe to the pump...page 30 Safety system to avoid free-flow...page 31

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SECTION 6 Device activation...page 33 SECTION 7 Key-pad lock out...page 34 Table of key-pad functions...page 35 SECTION 8 Programming...page 36 Programming of flow rate...page 38 Programming of bolus dose...page 39 Minimum interval time between bolus doses...page 40 Programming of bolus doses per hour...page 42 Programming of partial volume...page 44 SECTION 9 Starting the pump...page 46 Priming...page 47 Pump in on (running)...page 49 Bolus dose...page 50 Bolus dose limitations...page 51 Clinician bolus...page 51 Occlusion of infusion set...page 53 Post occlusion bolus...page 53 End of infusion...page 54 Reversal of the pump pusher...page 55 Switching off the pump...page 57 SECTION 10 Displaying programmed parameters...page 58 Displaying delivered volumes...page 60 Clearing the number of bolus doses delivered...page 62 Displaying the number of complete infusions...page 63 SECTION 11 Low battery alert...page 65 Battery installation or replacement...page 66 6 MAN 01/06/USA/p CRONO FIVE 11.10

SECTION 12 General cautions...page 68 User guide update...page 68 Maintenance...page 69 Cleaning...page 69 Storage...page 69 Pump life...page 69 Disposal of the pump...page 69 User information...page 70 SECTION 13 Manufacturer’s guarantee...page 71 SECTION 14 Alarm message...page 73 Short instructions...page 75 SECTION 15 Pump icon table...page 79 Syringe blister package icon table...page 80 SECTION 16 Statement of conformity...page 81 SECTION 17 Glossary...page 83 ANNEX Annex 1...page 85 Annex 2...page 87 Annex 3...page 88 Annex 4...page 89

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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 ambula tory drug infusion pump CRONO Five 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 Five 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 suita bility 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 MAN 01/06/USA/p CRONO FIVE 11.10

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 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 set, tubing and access devices 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. Please refer to Section 5 of this User Guide for detailed instructions of Safety System to Avoid Free-Flow. For patients that are likely to be adversely af fected by interrupted medica tion or fluid delivery from Crono Five, close supervision for immediate cor rective action should be provided. 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 10 MAN 01/06/USA/p CRONO FIVE 11.10

SECTION 1

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. Epidural drug infusions delivering drugs dif ferent 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 Five pumps with the aim of evaluating the correct function and accuracy . Such check ups must be carried out only by CAN È 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 Five 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 10098 Rivoli (T ORINO) Italy Tel: 0039-011-9574872 Fax: 0039-011-9598880 Email: [email protected]

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SECTION 2 DESCRIPTION OF THE PUMP CRONO Five is a new , innovative PCA pump that is very appreciated by health care professionals and patients due to its small size and technical features. CRONO Five is an ambulatory infusion pump especially suited for control led 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 MAN 01/06/USA/p CRONO FIVE 11.10

SECTION 2 INFUSION SYSTEM The pump administers shots of 5 microliters (µl or mcl) for any given flow rate. The time interval between shots decrease proportionally to increases in programmed flow rates. TECHNICAL FEATURES Pump size

77 x 47 x 29 mm.

Weight

115 g (battery included).

Battery

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

Syringe

Dedicated 10 and 20 ml capacity with luer-lock connector.

Administration volumes

From 1 ml to 20 ml with increments of 1 ml.

Priming

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

Flow rate

Programmable from 5 to 5000 mcl/h with the following increments: - from 5 to 1000 mcl/h with 5 mcl/h increments; - from 1000 to 5000 mcl/h with 10 mcl/h increments; The flow rate can be programmed to 0 ml.

Bolus dose

Programmable from 0.01 to 2.00 ml with 0.01 ml increments: The bolus dose can be programmed to 0 ml.

Clinician bolus

Programmable from 0.01 to 2.00 ml with 0.01 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. 14 MAN 01/06/USA/p CRONO FIVE 11.10

SECTION 2

Number of boluses doses per hour

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

Flow accuracy

+/-2% (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 0.4 ml (details are supplied on ANNEX 3).

Electric circuit

Electric circuit managed by a micro controller 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 anomalies 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% RH 700 hPa / 1060 hPa

Storage conditions

-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

Syringe

20 ml

Flow rate

1000 mcl/h

Bolus dose

0.2 ml

Interval between bolus doses

1h

Number of bolus doses in 1 hour

1

Clinician Bolus

0.00 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. User guide.

2

3 1

5 8

6

4

7

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SECTION 3 OPTIONAL ACCESSORIES Heightwise leatherette case similar to a cellular phone holder .

Detail belt clip

Detail opening

Color: black Size: 14 x 5,5 x 4 cm Weight: about 36 g Article code: CM/15

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SECTION 3

Lengthwise leatherette case similar to a glasses case.

Detail of belt loop

Color: black Size: 13 x 5,5 x 4 cm Weight:: About 50 g. Article code: CM/14

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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 ml

How to use elastic belt with pump and fabric holder .

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SECTION 4 PUMP OVERVIEW Syringe fin hook

Display Collar strap locking rings

Button d

Pusher

Button

- Button + Battery compartment

Serial number

Short instructions

CE mark

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SECTION 4 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 pro gress as well as giving warnings and alarm messages. Symbol "10 ml" : indicates the device has been set to use 10 ml (CRN 10) syringe setting. Symbol "20 ml" : indicates the device has been set to use 20 ml (CRN 10) syringe setting.

10 20

10 20

“Low battery” symbol: appears when the battery charge is low (see page 65).

“Drip” symbol: separates whole numbers from decimals.

“apostrophe” symbol: used when the duration of infusion is10given in minutes.

20

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