Crono User Guide MAN 01-C-05

TABLE OF CONTENTS SECTION 9

Switching on the device... page 27 Priming the infusion set... page 27 End of infusion... page 28 Storing data... page 28 Switch off... page 28 Reading the number of infusions... page 28 Re-setting the number of infusion... page 29 Reversal of pump piston... page 30 Piston movements... page 30 Infusion set occlusion... page 30 Tamper resistant feature... page 31

SECTION 10

Low battery alert... page 33 Battery replacement... page 33

SECTION 11

Cautions... page 35 Maintenance and cleaning... page 36 Storage... page 36

SECTION 12

User Assistance information... page 37 Manufacturer’s guarantee... page 37

SECTION 13

Alarm messages... page 39 Summary of functions and buttons... page 40

SECTION 14

Pump icon table... page 41 Syringe blister icon table... page 42

SECTION 15

A glossary of terms... page 44

SECTION 16

Index of illustrations... page 46

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SECTION 1 FOREWORD

CAUTION: US Federal law restricts this device for sale by or on order of a physician. This manual is written with the aim of informing the user of this pump. The instructions and details given here are fundamental for the correct and safe use of this device. Please take time to read all the information before using the pump and moreover keep this guide in a safe place for future reference.

NOTE

The manufacturer only considers itself responsible for the safety and reliable working of this pump, provided that it is used in accordance with the current instructions for use. The manufacturer declines all responsibility towards the purchaser and any third party for any damage to the pump caused by tampering, improper use, modifications and/or reparations by unauthorised personnel.

INTENDED USE

The ambulatory infusion pump Crono has been designed for subcutaneous drug infusions. Canè S.r.l. declines all responsibility for the administration of drugs and solutions and/or methods of drug infusions other than those described in this manual.

USER ASSISTANCE INFORMATION

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]

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SECTION 2 PUMP DESCRIPTION

Canè S.r.l. - a company specialized in the production of ambulatory pumps since 1972 - has developed a new generation of compact pumps: Crono which is a perfect combination of high technology and innovative design. Infusion pumps using normal commercial syringes are bulky and cumbersome and thus difficult to use in the true sense of "ambulatory". This can have a negative impact on patient compliance and treatment goals. A special syringe, an integral part of Crono, provides an efficient reduction of overall pump size. Whether day or night infusion is required, Crono offers more conveniences and advantages than other bulkier, heavier pumps. Patients who have been following subcutaneous infusion therapy for a long time often experience difficulties in absorbing the drug subcutaneously. This may lead to catheter occlusion with infusion interruption. Crono has a unique mechanism which responds to occlusion and provides an infusion thrust up to three times higher than conventional pumps. Normal infusion is resumed when catheter occlusion has been eliminated. In order to provide steady infusion and continuous drug absorption, Crono infuses the fluid volume to be administered in pulses of .022 ml. These pulses are spread evenly over the time set for completing the infusion.

FACTORY SETTINGS

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

20 ml

Audible signal for end infusion

AL.0 (Non active)

Key-pad lock level

Lo,0 (key-pad unlocked)

Delivery time

Number of infusions MAN 01/C/05

10 hours 0

8

TECHNICAL FEATURES Dimensions

77x48x29 mm (3x1.9x1.1 inch).

Battery

3 Volt type 123 A lithium battery.

Weight

Syringes

Volume administration Delivery time Accuracy

Available occlusion pressure Data storage

Safety circuits Tamper resistant feature Operating conditions Storage conditions

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115 g (battery included).

Dedicated with 10 or 20 ml capacity. Drug volume can be programmed from 1 to 20 ml.

Programmable from 30 minutes to 99 hours, in 15 minutes steps. +/- 2%.

4,5 bar +/-1.

Programmable data are automatically stored in the pump’s memory; the data are not lost when the battery is removed.

To control the regular working of the device, alarming in the event of anomaly and displaying error message. Allows the pump to be “locked” by disambling the buttons. +10°C / +45 °C 30% / 75% RH 700 hPa / 1060 hPa -10°C / +60 °C 10% / 100% RH 500 hPa / 1060 hPa MAN 01/C/05

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 Fig.1

2

3 1

6

8 7

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4

5

10

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

1

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.

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

Fig.3

10

20 ml

Fig.4

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How to use elastic belt with pump and fabric holder

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HOW TO WEAR THE PUMP The following pictures show the different ways the pump can be worn. Fig.5

WEARING THE PUMP AROUND THE NECK Wearing the pump around the neck with collar strap and fabric holder

Fig.6

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

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SECTION 5 PUMP PARTS Fig.7

Syringe fin hook

Display

Collar strap locking rings

d

Pump piston

Button

+ Button

- Button

Battery compartment

Serial number Brief instructions

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LIQUID CRYSTAL DISPLAY

This is a screen on the front of the pump displaying symbols which inform the patient of operations in progress as well as showing warnings and alarm messages. 10 20

10

“Battery” symbol: appears when the battery is nearly expired (see the related paragraph, page 30)

20

“Drip” symbol:

flashes when the device is on; it alternates with indication of hours and minutes

10 “10 ml” symbol: indicates the device has been programmed to use 10 ml (CRN 10) syringe 20 “20 ml” symbol:

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indicates the device has been programmed to use 20 ml (CRN 20) syringe

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SECTION 6 MAIN SCREEN INDICATIONS 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

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DELIVERY TIME PARTIAL VOLUME OFF INDICATION 20 ML SYRINGE SELECTED END OF INFUSION AUDIBLE SIGNAL (ON) ERROR MESSAGE OCCLUSION BACKWARDS/FORWARDS MOVEMENTS OF THE PUMP PISTON END OF INFUSION LOW BATTERY BATTERY DISCHARGED DISPLAYING THE NUMBER OF INFUSIONS KEY-PAD UNLOCKED KEY-PAD LOCKED: LEVEL 1 KEY-PAD LOCK SETTING

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SYRINGE PARTS

The Crono pump uses dedicated syringes which are available in two sizes: • CRN® 10 ml CRONO® Syringe • CRN® 20 ml CRONO® Syringe

The syringes are: • Single use only • To be used only if packaging is not damaged • Pyrogen-free

20ml

10

Fig.8

Syringe structure Plunger Plunger Rod

Needle Needle’s cap Luer-lock cap

LUER LOCK CAP FUNCTIONS

• Can be used after the syringe has been filled, in order to unscrew the plunger rod from the plunger with ease. • To protect the drug in the syringe if infusion is not imminent.

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Fig.9

Luer-Lock cap

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INFUSION SET

It is advisable to use infusion sets which have the following specification: • Tube with internal diameter of limited dimensions (optimum 0.36 mm, maximum 0.6 mm); • Length of the tube not exceeding 90 cm; • Tube with dead space lower than 0.5 ml; • Anti-kink tube.

Fig.10

INFUSION SET PARTS Female Luer lock

Needle Tube

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INFUSION SITES

Infusion sites can be any of the following:

Fig.11

• Anterior aspects of upper arm • Anterior abdominal wall • Anterior aspect of thighs It is advisable to change infusion site after each drug administration in order to avoid skin irritation.

INFUSION PREPARATION

Before preparing the equipment for infusion, it is advisable to follow these precautions:

cr n

min h

OFF

d

O CRON 0.2

19

ml

MICR

1 - Wash your hands 2 - Prepare a clean working area

OJET

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SYRINGE PREPARATION

1.Put the supplied needle on the syringe with a clockwise rotation. 2.Fill up the syringe, aspirating the drug slowly to avoid disconnection between the rubber plunger and plunger rod. Verify the drug inside does not exeed 10 or 20 ml capacity. 3.Unscrew the plunger with a brisk counter-clockwiser rotation. 4.Put the subcutaneous tubing on the syringe with a clockwise rotation. 5.Insert the syringe into the instrument with a 90° rotation, making sure to detect a “click” which indicates the syringes is locked into the pump.

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Fig.12

1

SYRINGE PREPARATION 2

4

3

5

10

10

20 ml 10

20 ml

20 ml

10 10

20 ml

20 ml

Fig.13

CONNECTION OF THE SYRINGE TO THE PUMP

min

h

0.2

ml

MIC

JE RO

NO

RO

TC

min

h

OFF

d

OFF

d

0.2

ml

JE RO

MIC

RO

TC

NO

Top view

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SECTION 7 WORKING INSTRUCTIONS

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

min

min

h

h

OFF

O

d

ON

T

l

m 0.2

R MIC

OJE

CR

Fig.14

OFF

d

ml 0.2

JE RO MIC

NO RO TC

• Time-controlled buttons: keep buttons pressed for a few seconds to activate commands. • Button activation is confirmed by a ticking sound, except in the phase of battery insertion. • Command execution is confirmed by a brief audible signal. • Before starting the infusion, check that the 10 ml or 20 ml syringe setting has been selected correctly. • The pump is supplied with a battery already inserted.

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PUMP ACTIVATION

During the device activation phase it is possible to select the following parameters: • Syringe size (10 ml or 20 ml) • End of infusion audible signal (ON or OFF) The syringe size and the end of infusion signal can only be selected and/or changed immediately after battery insertion. Device activation: 1. Remove, and then re-insert the battery 2. The pump will carry out a self-test, during which the display will show all readable symbols and emit audible signals 3. While syringe size symbol is flashing (the numbers “10“or “20”), you may select syringe sizes. Use the or buttons to make your selection. If, for example, the number “10” is flashing, press the button and keep it pressed for a few seconds until the number “20” appears. 10 20

10 20

10 20

10 ml syringe

+

-

10 20

10 20

10 20

20 ml syringe

10 20

10 20

The information regarding the syringe size will always be shown on the display. 4. After syringe size selection, you may activate/deactivate an audible signal for end of infusion. While the display blinks, you may select to either have the audible signal or not by pressing the or buttons .

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10 20

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Audible signal ON

10 20

Audible signal OFF

10 20

5. After a few seconds, the pump automatically returns the pump piston to its starting position, then the screen displays OFF.

10 20

The selected data are automatically stored in memory.

10

20 ml

Fig.15

20

20 ml

10

10 ml

10ml

5

20 ml syringe

10 ml syringe

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