CRONO S-PID User Guide Firmware ver S2P.02.00 Jan 2007

CRONO S-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/EN/03 S-PID 09/09 Firmware version: S2P.02.00 Firmware date: 31/01/07

SUMMARY SECTION 1 Introduction...Page 7 Intended use... Page 7 Infusion system... Page 8 Description of the pump... Page 9 Technical characteristics... Page 10 Manufacturing parameters... Page 12 Information... Page 12

SECTION 2 Equipment... Page 13 How to use the accessories provided... Page 14 How to wear the pump... Page 15 Optional accessories... Page 16

SECTION 3 Identifying the device components... Page 17 Liquid crystal display... Page 18 Examples of indications appearing on the display... Page 19 Keypad... Page 20

SECTION 4 Identifying the syringe components... Page 21 Luer Lock cap... Page 21 Infusion set... Page 22 Identifying the infusion set components... Page 22 Filter... Page 22 Identifying the filter components... Page 22 Infusion sites... Page 23 Infusion preparation... Page 23 Syringe preparation... Page 24 Attaching the syringe to the device... Page 26 Attachment sequence: front view... Page 26

SECTION 5 Keypad lock... Page 29

SECTION 6 Activation of the pump... Page 30 Programming... Page 31 Syringe type selection... Page 31 Infusion end acoustic signal... Page 33 Partial volume selection... Page 33 Flow rate selection... Page 34 Switching on the pump... Page 35 Infusion set refilling (Prime)... Page 35 MAN 01/EN/03 S-PID 09/09

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Infusion end... Page 36 Switching off... Page 36 Reversals of the pump pusher... Page 36 Pump pusher movement... Page 37 Infusion set occlusion... Page 37 Post-occlusion bolus... Page 38 Infusion number viewing... Page 39 Zeroing the infusion number... Page 39 Saving of set data... Page 40

SECTION 7 Battery low warning... Page 41 Replacing the battery... Page 41 Battery care... Page 43

SECTION 8 General warnings... Page 44 Manual updates... Page 45

SECTION 9 Maintenance... Page 46 Cleaning... Page 46 Storage... Page 46 Life of the pump... Page 46 Disposal... Page 46

SECTION 10 Assistance... Page 47 Warranty regulations... Page 47

SECTION 11 Error signals... Page 49

SECTION 12 Functions and keys summary... Page 50

SECTION 13 Symbols on the pump... Page 51 Symbols on the syringe blister package... Page 52

SECTION 14 Declaration of conformity... Page 53

ATTACHMENT Attachment 1... Page 54 Attachment 2... Page 56 Attachment 3... Page 57 Attachment 4... Page 58

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SECTION 1 INTRODUCTION The instructions contained in this manual only concern the CRONO S-PID ambulatory infusion pump and are addressed to the medical and paramedical personnel who must initially apply the pump and subsequently to patients. The pump is fitted with a keypad lock system (see page 29) that prevents any change to the programmed parameters. The information concerning the keypad lock/unlock procedure is provided at the end of this manual on a plasticized card. The purpose of the keypad lock is to prevent accidental and unauthorised changes to the selected parameters; in cases in which it is appropriate for the patient not to know this procedure, the physician and/or the assistant is advised not to provide the patient with this information. The instructions contained in this manual are fundamental for safe, correct use of the pump. Users are advised to read the entire manual before using the device and keep it for future reference. The pump does not require any installation, testing and/or start-up.

INTENDED USE The CRONO S-PID ambulatory infusion pump is designed exclusively for subcutaneous infusions in the treatment of primary immuno-deficiencies. CANÈ S.p.A. declines all responsibility for the administration of drugs and solution and/or methods of drug infusion which are not described in this user’s guide.

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SECTION 1 INFUSION SYSTEM The pump administers 22 µl doses at intervals that depend on the set flow rate. The time interval between doses decreases proportionally as the programmed flow rate increases.

WARNING Improper programming and/or the incomplete understanding of operating functions and alarms may cause death or serious injuries to the patient. Do not prime the infusion line when connected to the patient since this may cause a medication overdose. Before starting an infusion, inspect the route of the fluid to make sure that there are no folds, clamps or other occlusions upstream; remove any air bubbles. The accuracy, the amount of time necessary to signal an occlusion and the volume of the bolus released may vary from the values indicated in this manual, depending on the type of catheter, the infusion set and all the elements in the infusion line (additional details are provided in ATTACHMENTS 1, 2 and 3). In case of suspected damage to the pump for any reason (for example due to infiltration of liquid or falls), contact the Customer Support Service to ascertain the correct operation of the pump. Do not use the pump if damaged. Any trace of liquid on the outer part of the pump must be immediately removed with a soft cloth. Check the battery compartment of the pump, since any penetration of liquid may seriously damage the electronic circuits.

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SECTION 1 NOTES The manufacturer undertakes responsibility in association with the safety and operation of the device, provided that it is used in compliance with these instructions and that any repairs and/or changes have been performed exclusively by the same manufacturer.

DESCRIPTION OF THE PUMP CRONO S-PID is a portable syringe pump intended for the controlled subcutaneous administration of medication. CRONO S-PID is a product of advanced technology and innovative design. Its reduced size and light weight make it ideal for home use with consequent freedom for the patient to perform daily tasks and enjoy entertainment activities during the infusion. CRONO S-PID uses 10 and 20 ml syringes designed specifically for the pump. For improved medication absorption CRONO S-PID administers 22 µl per impulse. The advancement mechanism, which pushes directly on the rubber syringe piston, which makes it possible to reach a significant trust force and high accuracy of administration. In the event of occlusion of the administration set, an innovative infusion control system allows the infusion to be automatically continued until completion, removing the occlusion. CRONO S-PID is equipped with a liquid crystal display showing the physician and patient useful information concerning the pump’s programming, operation and diagnostics.

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SECTION 1 TECHNICAL CHARACTERISTICS Size

77 x 48 x 29 mm.

Weight

116 g (battery included).

Battery

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

CRN syringes®

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

Flow rate

Programmable as follows: - 0.2ml/h to 40ml/h (10 ml syringe); - 0.4ml/h to 40ml/h (20 ml syringe).

Flow rate accuracy

+/-2%.

Occlusion pressure

6.0+/-2 bars.

Occlusion signaling time

See ATTACHMENT 2.

Post occlusion bolus

Around 0.9 ml (details are provided in ATTACHMENT 3).

Electronic circuit

Managed by a microcontroller with dedicated software.

Data storage

Selected data is automatically stored in the memory and is not lost when the battery is removed.

Display

Liquid crystal.

Motor

Coreless direct current motor. The microcontroller manages the rotation through an infrared encoder.

Keypad lock

Two levels can be set.

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SECTION 1

Safety circuits

They monitor the correct operation and intervene in case of fault by activating sound signals and messages on the display.

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 1 MANUFACTURING PARAMETERS The pump is supplied with the following settings: Syringe

20 ml

Infusion end acoustic signal

AL.1 (active)

Keypad lock level

L 0 (unlocked)

Flow rate

1 ml/h

Number of infusions

0

INFORMATION For further information on the CRONO S-PID pump contact: • Servizio Assistenza Clienti (Customer Support Service) CANÈ S.p.A. Medical Technology Via Cuorgnè, 42/a 10098 Rivoli (Turin) - Italy Tel. +39.011.9574872 Fax +39.011.9598880 MAN 01/EN/00 S-PID 03/07 Internet: www.canespa.it E-mail: [email protected]

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SECTION 2 EQUIPMENT 1. CRONO S-PID ambulatory infusion pump. 2. Pump case (Code: VAL/01). 3. Elastic belt (Code: CM/01). 4. Collar strap (Code: CM/03). 5. Fabric case (Code: CM/02). 6. 2 batteries (1 of which is inside the pump) (Code: CR/123A). 7. User’s guide. 8. Battery tool (Code: CA/02).

2

7

3 5 6 1

4 8

Fig.1

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SECTION 2 HOW TO USE THE ACCESSORIES PROVIDED The figures below provide indications on the use of the accessories supplied with the pump.

Use of the collar strap and the fabric case. 10

20 ml

Fig.2

Use of the elastic belt and the fabric case.

Fig.3

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SECTION 2 HOW TO WEAR THE PUMP The figures below show how to wear the pump. PUMP WORN AROUND THE NECK

Pump worn with the collar strap and the fabric case.

Fig.4

PUMP WORN AROUND THE WAIST

Pump worn with the elastic belt and the fabric case.

Fig.5

PUMP WORN ON THE ARM

Pump worn with elastic arm band (optional).

Fig.6

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SECTION 2 OPTIONAL ACCESSORIES Optional cases available on request: CM/13: heightwise imitation leather case with window and belt loop to be used with pump and a 10 or 20 ml syringe. Size (LxWxH): 5.5x4x14.5 cm. CM/20: heightwise imitation leather case with window and belt loop to be used with pump and a 10 ml syringe. Size (LxWxH): 5.5x4x12 cm. Fig.7

PUMP WORN ON A BELT WITH HEIGHTWISE IMITATION LEATHER CASE Fig.8

CM/14: Lengthwise imitation leather case and belt loops to be used with pump and 10 and 20 ml syringes. Size (LxWxH): 13x3.5x6 cm). CM/21: lengthwise imitation leather case and belt loops to be used with pump and 10 ml syringe. Size (LxWxH): 11.5x3.5x6 cm.

Fig.9

PUMP WORN ON A BELT WITH HEIGHTWISE IMITATION LEATHER CASE

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SECTION 3 IDENTIFYING THE DEVICE COMPONENTS Syringe fin hook

Display Collar strap locking rings

Button

Button

Pusher

Button

P

+

Battery compartment

Serial number Short instructions CE mark

Fig.11

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SECTION 3 LIQUID CRYSTAL DISPLAY The pump is fitted with a liquid crystal display showing text messages and symbols in order to provide the user with information concerning settings, operations in progress and alarm situations.

10 20

“Low Battery” symbol: appears when the battery is low (see the relative paragraph on page 41).

“10 ml” symbol: indicates that the device has been programmed to use 10 ml syringes (CRN® CRONO® Syringe 10)

“20 ml” symbol: indicates that the device has been programmed to use 20 ml syringes (CRN® CRONO® Syringe 20)

10 20

10 20

“Drop” symbol: flashes when the device is in operation; separates the indication of the hours from the indication of the minutes.

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SECTION 3 EXAMPLES OF INDICATIONS APPEARING ON THE DISPLAY PUMP OFF

10 20

10

TIME REMAINING UNTIL THE END OF THE INFUSION

FLOW RATE (ml/h)

20

10 20 10

SYRINGE SELECTED (20 ml/h)

INFUSION END ACOUSTIC SIGNAL ON

INFUSION END ACOUSTIC SIGNAL OFF

ERROR MESSAGE

FEED/REVERSAL MOTION OF THE PUMP PUSHER

INFUSION END

LOW BATTERY

BATTERY DISCHARGED

20

10 20

10 20

10 20

20

10 20

10 20

10 20

10

TOTAL NUMBER OF INFUSIONS

PARTIAL VOLUME SELECTION

20

10 20 10

PARTIAL VOLUME

KEYPAD UNLOCKED

KEYPAD LOCKED

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10 20

10 20

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SECTION 3 KEYPAD The keypad consists of 3 buttons. The buttons are timed: they must be pressed for a few seconds before the command is executed. • The pressing of the buttons is confirmed by an acoustic signal similar to a ticking noise. • The execution of the commands is validated by a short acoustic signal. While selecting the parameter, the button is used to decrease the value displayed, the button to increase the value displayed.

WARNING The buttons must be pressed with the fingertips only; do not use pointed objects.

Fig.12

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Fig.13

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SECTION 4 IDENTIFYING THE SYRINGE COMPONENTS The CRONO S-PID pump uses its own special syringes available in two models: • CRN® CRONO® 10 ml syringes. • CRN® CRONO® 20 ml syringes. The syringes are: disposable and pyrogen-free. Do not use if the package is damaged or open.

Syringe body

Needle

Piston

Needle cover

Piston rod

Luer-Lock cap Fig.14

LUER LOCK CAP It can be used: • After filling the syringe to facilitate the unscrewing of the piston rod from the piston. • To protect the medication inside the syringe in case it is not used immediately.

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.

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