CRONO Super PID User Guide USA Firmware ver S2.02.02 Nov 2009

CRONO Super PID USER’S 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/USA/04 Super PID 11/09 Firmware version: S2.02.02 Firmware date: 14/04/08

TABLE OF CONTENTS SECTION 1

Foreword... page 7 Note... page 7 Intended use... page 7 User assistance information... page 7

SECTION 2

Description of the pump... page 8 Factory settings... page 8 Technical data... page 9

SECTION 3

Standard equipment supplied... page 10 Optional accessories... page 11

SECTION 4

How to use standard equipment supplied...page 12 How to wear the pump...page 13

SECTION 5

Pump overview... page 14 Liquid Crystal Display (LCD)... page 15 Main screen indications... page 16

SECTION 6

Syringe parts... page 17 Use of luer lock cap... page 17 Warnings... page 17 Infusion set... page 18 Infusion set parts... page 18 Infusion sites... page 19 Preparation for infusion... page 19 Preparation of the syringe... page 19 Connection of the syringe to the pump... page 20

SECTION 7

Working instructions... page 21 Lock functions... page 22 Device activation... page 23

SECTION 8

Programming... page 24

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TABLE OF CONTENTS SECTION 9

Switching on the pump... page 28 Priming the infusion set... page 28 End of infusion... page 29 Switching off the pump... page 29 Pusher reversing possibilities... page 29 Pusher movements... page 30 End of infusion acoustic signal... page 30 Infusion set occlusion... page 30 Storing data... page 30 Reading the number of infusions... page 31

SECTION 10

Low battery alert... page 32 Battery replacement... page 32

SECTION 11

Cautions... page 34 Maintenance and repair... page 35 Cleaning... page 35 Storage... page 35 Pump life... page 35

SECTION 12

User Assistance information... page 36 Manufacturer ’s guarantee... page 36

SECTION 13

Alarm message... page 38 Summary of functions and buttons... page 39

SECTION 14

Pump icon table... page 40 Syringe blister icon table... page 41

SECTION 15

Statement of conformity... page 42

SECTION 16

Index of illustrations... page 43

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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 for users of the CRONO Super PID pump. The instructions and information in this manual are fundamental for the correct and safe use of this device. Please take the time to read all the information before using the pump and keep this guide together with the pump 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 other person for any damage to the pump caused by tampering, improper use, modifications and/or reparations by unauthorised persons.

INTENDED USE

The ambulatory infusion pump CRONO Super PID is designed exclusively for subcutaneous drug infusions. The pump is not suitable for intravenous infusions. CANÈ S.p.A. declines all responsibility for the administration of drugs and solutions and/or methods of drug infusion which are not described in this user manual.

USER ASSISTANCE INFORMATION

For further information on the CRONO Super PID, please contact: Customer Assistance Service

Intra Pump Infusion Systems 920 Minters Chapel Rd, Suite 200 Grapevine, TX 76051 Tel: 866-211-7867 Fax: (630) 845-2768 www.intrapump.com 7

MAN 01/USA/04 SuperPID 11/09

SECTION 2 DESCRIPTION OF THE PUMP

CRONO Super PID is an ambulatory syringe infusion pump intended for the controlled, subcutaneous administration of liquids. CRONO Super PID combines high technology with innovative design. The small size and other features makes the pump ideal for ambulatory use, which means that the patient can be completely mobile during the infusion and does not have to interrupt daily life or leisure activities. Specially designed PID syringes have to be used for either 10 ml or 20 ml infusions. CRONO Super PID has a particular mechanism, which pushes directly on the rubber syringe plunger, which makes it possible to reach a significant thrust force and high accuracy of administration. CRONO Super PID administers 22 µl per impulse (using a 10/20 ml syringe). In case of infusion set occlusion, an innovative infusion control system makes it possible to proceed with the infusion automatically and, after the occlusion is eliminated, to complete the infusion. CRONO Super PID is fitted with a liquid crystal display which shows the time it takes to complete the delivery, the syringe size and the battery charge status.

FACTORY SETTINGS

The CRONO Super PID pumps are pre-programmed at the factory as outlined below but can be reprogrammed by the user to fit other drug protocols (see section 7-9) Syringe size

20 ml

Acoustic signal for end infusion

AL.1 (Active)

Delivery time

1h

Lock level

MAN 01/USA/04 SuperPID 11/09

L 0 (unlocked)

8

TECHNICAL DATA

Pump size

77 x 48 x 29 mm (3 x 1.9 x 1.1 inch).

Battery

CR 123A 3V Lithium battery.

Weight

Syringes Delivery time

Accuracy

Occlusion pressure Data storage

Lock level

Safety circuits

Operating conditions Storage conditions 9

116 g (battery included).

10 and 20 ml dedicated syringes with universal “luer-lock ” steps..

Programmable from: -1 h to 99 h with 15 min steps; -15 min to 1 h with 5 min steps (10 ml syringe); -30 min to 1 h with 5 min steps (20 ml syringe). +/-2%.

6,0 +/-2 bar.

Programmable data are automatically stored in the pump’s memory. The data is not lost even if the battery is removed. Locked /unlocked.

Designed to control the regular working of the pump, alarming in the event of an anomaly and displaying alarm messages. +10 °C /+45 °C 30%/75%RH 700 hPa /1060 hPa. -10 °C /+60 °C 10%/100%RH 500 hPa /1060 hPa. MAN 01/USA/04 SuperPID 11/09

SECTION 3 STANDARD EQUIPMENT SUPPLIED

1. Ambulatory infusion pump (Code:CRONO Super PID English). 2. Pump case (Code:VAL/01). 3. Elastic belt (Code:CM/01). 4. Collar strap (Code:CM/03). 5. Fabric holder (Code:CM/02). 6. 2 batteries - one already inserted in the pump -(Code:CR/123A). 7. User’s guide. 8. Battery tool (Code:CA/02). Fig.1

2

3 1

6

4 5

7 8

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OPTIONAL ACCESSORIES

Optional accessories are available upon request: 1. Heightwise leatherette case similar to a cellular phone holder (Code: CM/15). Fig. 2

2. Lengthwise leatherette case similar to a glasses case with a belt loop (Code: CM/14). Fig. 3

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SECTION 4 HOW TO USE THE STANDARD EQUIPMENT SUPPLIED

The following pictures show how the pump and its accessories should be used.

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

Fig.4 10

20 ml

Fig.5

How to use elastic belt with the pump and the fabric holder

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HOW TO WEAR THE PUMP

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

Fig.6

WEARING THE PUMP AROUND THE NECK

Wearing the pump around the neck with a collar strap and a fabric holder (imitation leather holder similar to spectacle case is optional).

Fig.7

WEARING THE PUMP AT THE WAIST

Wearing the pump at the waist with an elastic belt and a fabric holder (imitation leather holder similar to a mobile telephone holder is optional).

Fig.8

WEARING THE PUMP ON THE ARM

Wearing the pump on the arm with an elastic belt (optional).

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SECTION 5 PUMP OVERVIEW

Syringe fin hook

Fig.9

Display

Collar strap locking rings

Button p

Button

Pusher

-

Button

+

Battery compartment

Serial number Short instruction CE mark

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14

LIQUID CRYSTAL DISPLAY (LCD)

This is a screen on the front of the pump where symbols are displayed informing about operations in progress as well as giving warnings and alarm messages. 10

20

10 20

“Low battery” symbol: appears when the battery charge is low (see page 32). 10 “10 ml” symbol: indicates that the pump has been programmed to be used with a 10 ml syringe. 20 “20 ml” symbol: indicates that the pump has been programmed to be used with a 20 ml syringe. “Drip” symbol: flashes when the device is on; it alternates with indication of hours and minutes.

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MAIN SCREEN INDICATIONS 10 20

10 20

10 20

10 20

10 20 10 20

20 10 20

10 20

10 20

10 20

10 20 10 20

10 20 10 20

PROGRAMMED DELIVERY TIME AND REMAINING DELIVERY TIME PUMP OFF SELECTED SYRINGE SIZE (10 OR 20 ML) END INFUSION ACOUSTIC SIGNAL (ON) END INFUSION ACOUSTIC SIGNAL (OFF) ERROR MESSAGE FORWARDS/BACKWARDS MOVEMENTS OF THE PUSHER END INFUSION LOW BATTERY BATTERY DISCHARGED NUMBER OF INFUSIONS BEGINING OF PARTIAL VOLUME PHASE PARTIAL VOLUME POSITIONING INDICATION (EXAMPLE) PUMP UNLOCKED INDICATION PUMP LOCKED INDICATION

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SECTION 6 SYRINGE PARTS

The CRONO Super PID pump uses especially designed PID syringes, which are available in two sizes: • CRN® 10 ml CRONO® PID Syringe • CRN® 20 ml CRONO® PID Syringe

The syringes are: • sterile. • single use only. • to be used only if packaging is not damaged. • pyrogen-free. Fig. 10

Syringe body Needle Piston Piston Rod

Needle’s protection Luer-lock cap

WARNINGS

• For safety purposes must be used only original CRN® Crono® Syringes. • The use of syringes of other types may damage the pump and harm its user. • CANÈ S.p.A. assumes no responsibility if the device is used with nonoriginal syringes different from those recommended.

USE OF LUER LOCK CAP

• Replace the luer-lock cap on the syringe after the syringe has been filled and the filling needle removed. • This simplifies the removal of the rod and keeps the solution intact before the infusion starts. 17

MAN 01/USA/04 SuperPID 11/09

INFUSION SET

The most appropriate infusion sets have the following specifications: • Length of the catheter not exceeding 90 cm; • Catheter with dead space less than 0.5 ml; • Anti-kink catheter. Fig.11

INFUSION SET PARTS

Female Luer Lock connector

Adhesive Needle

Needle cover

MAN 01/USA/04 SuperPID 11/09

Tube

18

INFUSION SITES

Infusion sites can be any of the following: • Anterior area of upper arm. • Anterior abdominal wall. • Anterior area of thighs.

Fig.12

If the total volume to be administered subcutaneously is too much to administer in one infusion site without causing skin problems, put the pump in “OFF” by pushing the and buttons simultaneously for a few seconds, change infusion site, and restart the pump by pushing the button for a few seconds.

PREPARATION FOR INFUSION Before preparing the pump for the infusion, it is advisable to follow these precautions: cr n

min h

OFF

d

O CRON 0.2

ml

OJET

MICR

1. Wash your hands. 2. Prepare a clean working area. 3. Check that all necessary material for the infusion is at hand.

PREPARATION OF THE SYRINGE

1. Attach the supplied needle to the syringe with a clockwise rotation. 2. Draw up the infusion solution slowly. Do not overfill the 10 ml or 20 ml syringes. 3. Attach the luer-lock cap.

4. Unscrew the rod of the syringe with a counter-clockwise rotation with a fairly swift movement. 5. Attach the infusion set to the syringe.

6. Attach the syringe to the pump by turning it 90°. You will hear a click when the syringe is securely in place.

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1

PREPARATION OF THE SYRINGE 2

4

3

5

6

Fig.13

Fig.14

CONNECTION OF THE SYRINGE TO THE PUMP

Top view

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WORKING INSTRUCTIONS

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

Fig.15

• The buttons are time-controlled: keep buttons pressed for a few seconds 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. • 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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