CRONO S-PID User Guide Oct 2012

Canè S.p.A. Medical Technology Via Cuorgnè 42/a 10098 Rivoli (TO) Italy Tel.+39 011 957 4872 - Fax +39 011 959 8880 www.canespa.it - [email protected]

Manual code: MAN 01/EN/00 CRONO S-PID Publication date: 10/12 3

CONTENTS S EC TIO N 1 Symbols and conventions...

Page 8

SEC TION 2 Introduction... WARNING: PRECAUTIONS FOR USE... Information...

Page 9 Page 10 Page 10

SEC TION 3 Intended use... Pump description... Infusion system... Technical characteristics...

Page 11 Page 13 Page 13 Page 14

SEC TION 4 Equipment supplied...

Page 16

SEC TION 5 Pump parts... Control buttons... LED... Liquid crystal display (LCD)... Low battery indicator... Battery replacement...

Page 17 Page 18 Page 18 Page 19 Page 21 Page 22

SEC TION 6 Settings lock...

Page 24

SEC TION 7 Errors and anomalies... Infusion set occlusion... Post-occlusion bolus...

Page 25 Page 28 Page 28 5

MAN 01/EN/00 CRONO S-PID 10/12

S ection 8 Factory settings...

Page 29

S ection 9 Quick reference...

Page 30

Section 10 Pump initialisation... Pump settings sequence with the pump OFF condition... Setting the reservoir type... Setting of end of infusion acoustic signal... Setting the partial volume... Setting the flow rate... Switching on the pump... The pump in ON condition... Priming the infusion line... Toggling between visualization of infusion duration and flow.. . End of infusion... Withdrawing the pusher... Switching off the pump... Displaying the settings... Resetting the number of infusion counter...

Page 32 Page 33 Page 33 Page 34 Page 35 Page 37 Page 38 Page 38 Page 39 Page 40 Page 41 Page 42 Page 44 Page 44 Page 45

Section 11 Reservoir parts... Luer-lock cap functions... Infusion set... Infusion set parts... Preparation of the reservoir and connection to the pump... Connection of the reservoir to the pump... Infusion sites... Preparing for the infusion...

Page 46 Page 46 Page 47 Page 47 Page 48 Page 49 Page 51 Page 51

6 MAN 01/EN/00 CRONO S-PID 10/12

S E C T ION 12 How to use the accessories supplied...

Page 54

SEC TION 13 GENERAL WARNINGS... Maintenance... Storage... Disposal... Expected pump life... Support ... Guarantee ... Declaration of conformity...

Page 55 Page 56 Page 56 Page 56 Page 56 Page 57 Page 58 Page 60

A PPEN D ICES Appendix 1: ... Appendix 2: ... Appendix 3: ... Appendix 4: ... Appendix 5: ... Appendix 6: ... Appendix 7: ... Appendix 8: ...

Page 62 Page 64 Page 66 Page 70 Page 71 Page 72 Page 74 Page 77

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SECTION 1 SYMBOLS AND CONVENTIONS To assist you in using the manual, the following symbols and conventions have been used: Triangle containing an exclamation mark This “Warning” icon indicates something that must always be taken into consideration for safe use of the pump. Notepad This icon indicates “Notes” containing additional information or useful tips about the use of the pump. Flashing symbol The graphic symbol shown in the manual above the pictures of the pump display, indicates that the information below it is flashing. This manual is divided into 5 parts: Part 1 (red): sections 1 to 7, general information, technical specifications

and warnings.

Par t 2 (blue): sections 8 to 10, describe the functions of the

CRONO S-PID device.

Part 3 (orange): section 11, which describes the reservoir, the preparation and

insertion of the reservoir into the pump, the infusion sites and the preparation for an infusion.

Part 4 (purple): sections 12 and 13, giving general warnings and a description

of the accessories supplied, as well as discussing maintenance, disposal and support. It also details the guarantee and the declaration of conformity. Appendices: pages 61 to 78.

8 MAN 01/EN/00 CRONO S-PID 10/12

SECTION 2 INTRODUCTION Thank you for having chosen the ambulatory infusion pump, model: CRONO S-PID. This manual has been prepared to enable you to make the best use of the CRONO S-PID pump, supplying information on the settings, safe use and maintenance of the device. If any of the information is not clear, or if you have any doubts or questions, please contact the Customer Support Service of CANè S.p.A. Incorrect use of the pump, or failure to follow the instructions and warnings provided in this manual could cause serious injury. The instructions provided herein are exclusively with respect to the ambulatory infusion pump, model: CRONO S-PID and are intended for use by the medical and paramedical personnel who need to set up the pump initially, and subsequently by patients who are capable of managing their therapy autonomously, or persons who are caring for patients. The pump has a settings locking system (see page 24) which stops the settings from being modified by accident. The information relating to the locking/unlocking of the settings lock is supplied at the back of this manual on a plastic card. The purpose of the settings lock is to avoid accidental or unauthorised modification of the selected parameters. If it is considered inappropriate that the patient should be aware of how to unlock the settings lock, the doctor and/ or other person who is assisting the patient should not supply this information. The instructions in this manual are essential for the safe and correct use of the pump. You are recommended to read the whole manual before starting to use the device and to keep the manual handy for future reference. The pump does not need to be installed, tested and/or activated. Canè S.p.A. reserves the right to modify the hardware and software specifications described in this manual at any time and without notice. 9 MAN 01/EN/00 CRONO S-PID 10/12

SECTION 2 NOTES • Canè S.p.A. reserves the right to modify and/or update this manual at any time and without notice. • In order to make this manual as complete and accurate as possible, please report any errors or omissions to the following e-mail address: [email protected].

WARNING: PRECAUTIONS FOR USE This pump is not recommended for independent use by patients who are unable to follow and understand the instructions supplied in this manual or unable to perform the basic operations and the regular maintenance of the pump.

INFORMATION For further information about 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. +39 011 957 4872 Fax +39 011 959 8880 Internet: www.canespa.it E-mail: [email protected]

10 MAN 01/EN/00 CRONO S-PID 10/12

SECTION 3 INTENDED USE

The CRONO S-PID ambulatory infusion pump is designed for the subcutaneous infusion of immunoglobulins and drugs in general. Canè S.p.A. disclaims all responsibility for the administration of drugs by other methods.

NOTE The manufacturer holds itself responsible for the safety of patients and the correct functioning of the device provided that it is used in accordance with these instructions, and that any required repairs and/or modifications are carried out exclusively by the said manufacturer.

WARNINGS The use of incorrect settings and/or incomplete understanding of the operational functions and of the alarms could cause serious harm to the patient. Before using the pump, evaluate whether its use is appropriate for the need and for the patient, paying close attention to the following aspects: - The technical specifications of the pump - The infusion sets which will be used - Whether you will be using multiple tube sets and clamps in the infusion line - The cognitive and psycho-physical condition of the patient. With respect to the clinical procedural aspects, which are the responsibility of medical or paramedical personnel, the above list is supplied for example purposes only and is not exhaustive. The device must be used: - Under the control of a doctor - Adopting appropriate procedures and adequate measures when dealing with patients who could suffer serious consequences (injury or death) in the event of accidents and/or breakdowns which cause an interruption of the administration of the drug. 11 MAN 01/EN/00 CRONO S-PID 10/12

SECTION 3 Do not prime the infusion line when it is connected to the patient, because this could cause an overdose of the drug. Before beginning an infusion, inspect the infusion line to ensure there are no folds, clamps, or other occlusions in the line, and expel any air bubbles. The precision and the time needed to indicate an occlusion could vary with respect to the values indicated in this manual, depending on the type of catheter, the infusion set and all the elements which comprise the infusion line. If you have any suspicion that the pump has been in any way damaged, for example by fluid penetration or having been dropped, contact the Customer Support Service to check that the pump is functioning correctly. Do not use a damaged pump. If you have any doubts about the functioning of the pump and/or an error or anomaly occurs, stop using the device and contact the Customer Support Service. Canè S.p.A. does not supply a replacement service for the pump during the period needed for any repairs; such service should be supplied by the relevant medical structure or the local distributor. Any liquid on the pump casing must be removed immediately with absorbent paper. It is important to establish a procedure and/or alternative to pumped infusion, in case the pump malfunctions. A valid alternative could be to have both a second pump and an alternative backup system. It is recommended that the individuals who assist and/or live with the pump user know how the pump works and the information in this user manual. It is important to stop using the device after the indicated service life has expired and follow the instructions for its correct disposal. Do not administer immunoglobulins intravenously; if they are accidentally administered to a blood vessel or capillary the patient could suffer an anaphylactic shock or thromboembolic events. Always check this before continuing with an infusion.

12 MAN 01/EN/00 CRONO S-PID 10/12

SECTION 3 PUMP DESCRIPTION CRONO S-PID is an ambulatory infusion pump for controlled subcutaneous administration of drugs. CRONO S-PID is a union of high technology and innovative design. Its reduced dimensions and weight make it ideal for home use, giving the patient the freedom to engage in everyday activities during the therapy. CRONO S-PID uses 10 and 20 ml dedicated reservoirs. To improve the absorption of the drugs, CRONO S-PID administers 22 µl per shot. The pusher mechanism, which operates directly on the rubber piston of the reservoir, enables the pump to combine high delivery pressure with excellent precision while administering the drugs. An innovative infusion control system allows the pump to automatically restart and finish an infusion after an occlusion has been removed. CRONO S-PID is provided with a liquid crystal display (LCD) which shows practical information to the doctor and patient about the settings, operations and diagnostics of the pump.

INFUSION SYSTEM The pump administers microdoses (shots) of 22 µl at intervals which depend on the configured flow rate. For example, programming a flow of 20ml/h with a 20 ml reservoir, the interval between two shots is approx 4 sec, whereas with a flow of 2 ml/h and a 20 ml reservoir, the interval between two shots is approx 40 seconds.

13 MAN 01/EN/00 CRONO S-PID 10/12

SECTION 3 TECHNICAL CHARACTERISTICS Pump dimensions

76 x 49 x 29 mm (3.00 x 1.94 x 1.15 in).

Weight

115 g (4.06 oz.), including battery.

Battery Lithium CR 123A 3V (battery life approx 200 infusions). Single-use reservoirs  Dedicated, with a 10 and 20 ml capacity and a “Luer-Lock” universal safety attachment. Partial volume Selectable, from 1 to 10 ml in 1 ml  increments (10 ml reservoir). Selectable, from 1 to 20 ml in 1 ml increments (20 ml reservoir). Flow rate Programmable from: 0.20 ml/h. to 40.00 ml/h. Available priming volume

1.5 ml.

Flow rate accuracy

+/-2%.

Occlusion pressure

6.0 bar +/- 2.0

Shot volume  22 microlitres (shot: quantity administered for every rotation of the motor). Occlusion signalling time

See Appendix 4.

Post-occlusion bolus Approx 1.2 ml. Settings memory All settings are automatically stored in a flash memory which is retained even if the device is left without a battery. 14 MAN 01/EN/00 CRONO S-PID 10/12

SECTION 3 Display  Liquid crystal display (LCD) (1.1 x 2.8 cm; 0.43 x 1.0 in). Motor  Coreless DC motor, the rotation of which is controlled by an infrared system. Settings lock

Two configurable levels.

Electronic circuit with  Ensures a more reliable and safer infusion twin microcontrollers system. Safety circuits  These check that the device is functioning correctly, intervening in the event of any anomaly with sounds and messages on the display. Ingress protection rating

IP 42

Pump operating conditions +10°C / +45°C. 30% / 75% RH. 700 hPa / 1060 hPa. Pump storage conditions -10°C / +60°C. 10% / 85% RH. 500 hPa / 1060 hPa.

15 MAN 01/EN/00 CRONO S-PID 10/12

SECTION 4 EQUIPMENT SUPPLIED

1. CRONO S-PID ambulatory infusion pump. 2. Pump carry-case (Code: VAL/05). 3. Elastic belt (Code: CM/01). 4. Fabric pouch (Code: CM/02/B). 5. Collar strap (Code: CM/18D). 6. 2 Batteries (one of which is already inserted in the pump) Code: CR/123A). 7. Battery-cover opening tool. 8. User Manual.

2

8

4 7

6

1

5 3

16 MAN 01/EN/00 CRONO S-PID 10/12

SECTION 5 PUMP PARTS Attachment for the reservoir wings

Led

Display Supporting eyelets of the supporting collar strap Buttons

Pusher

Anti-slip grooves Battery compartment

Serial no.

Quick reference

CE marking

17 MAN 01/EN/00 CRONO S-PID 10/12

SECTION 5 CONTROL BUTTONS There are 3 control buttons. The buttons have a built-in safety delay: you must keep them pressed for several seconds before the command takes effect. Use only your fingertips; do not use sharp objects. The buttons make a ticking sound when pressed. A brief beep confirms that a command is being executed.

WARNING The buttons have different functions according to which of the following conditions the pump is in when they are pressed: - OFF - StoP - ON The functions of the buttons in the various different conditions mentioned above are described in the quick reference instructions on pages 30 and 31 and in Section 10.

LED The red LED to the right of the display is switched on in the following circumstances: 1 - When the battery is inserted during the pump verification checks, see page 32. 2 - When an error has occurred, see pages 25-27. 18 MAN 01/EN/00 CRONO S-PID 10/12

SECTION 5 LIQUID CRYSTAL DISPLAY (LCD) The liquid crystal display uses text messages and icons to display practical information about the settings, the operation being performed and any error situations. Four main digits

Arrow icon

Two secondary digits Battery condition indicator

Lock indicator Drop icon

Four main digits of the display Display principal information related to the values of the settings, error information, etc. Two secondary digits of the display Display: • The volume of the selected reservoir • Information related to the setting being displayed in the four main digits • The unit of measurement of the setting being displayed. 19 MAN 01/EN/00 CRONO S-PID 10/12

SECTION 5 “Low battery” indicator Displayed when the battery is low (see related section on page 21).

Drop icon Flashing: the hour and minute separator.

Arrow icon The arrow indicates that the pump is being programmed. PROG

Minute indicator Flashes when the remaining delivery time is expressed in minutes (time left is less than 60 minutes). Lock indicator Indicates that the settings are locked (L1); i.e. they can be viewed but cannot be changed.

20 MAN 01/EN/00 CRONO S-PID 10/12

SECTION 5 LOW BATTERY INDICATOR The appearance of the “LOW BATTERY” alert (not flashing) on the display indicates that the battery is low. If the alert remains displayed for several consecutive infusions, the “SPENT BATTERY” message is displayed, accompanied by a beep repeated approximately every 10 seconds. In these circumstances the pump can no longer be used and the battery must be replaced. During battery replacement, when in the OFF or StoP conditions, the pump retains the current settings and the position of the pusher in its memory. If the battery needs to be changed during an infusion the pump must be in the StoP condition. If the battery is removed with the pump in the ON condition, the pump is automatically re-initialized, i.e. the pusher is withdrawn and repositioned to start an infusion, displaying OFF on the display.

WARNINGS • Do not use rechargeable batteries. • Using other types of battery than lithium CR 123 A batteries could cause the pump to malfunction. • The battery life can be influenced by the age of the battery and the temperature and circumstances of its use and storage. • Ensure you always have a replacement battery available for use. • If the pump is left inactive for long periods (1-2 months or more), you are advised to remove the battery.

NOTES • After you have inserted the battery, the pump runs a self-diagnosis test during which it will emit brief audio signals and display all of the icons and indicators. •W  hen you have finished changing the battery, check that the compartment is properly closed. 21 MAN 01/EN/00 CRONO S-PID 10/12

SECTION 5 BATTERY REPLACEMENT

Use a 3 Volt Lithium battery, model 123 A. To replace the battery, ensure that the pump is switched off (the display showing OFF or StoP), and then proceed as follows: 1. Open the battery compartment using the PID battery tool for this purpose. 2. Pull out the cover. 3. Use the small ribbon strap (which lies under the battery) to facilitate the removal of the battery. 4. Remove the discharged battery and discard it properly. 5. Insert the new battery checking that it is in the correct position and that the ribbon strap is under the battery. 6. After having installed the battery, close the cover.

NOTES In the event that it is not possible to remove the battery using the ribbon strap do not use an object to lever out the battery, but proceed as follows: • Hold the pump and the compartment cover firmly in one hand. • Strike the palm of your other hand with the pump to jolt the battery from the compartment. • The cover is supplied with a gasket which must remain in position as indicated in the illustration.

Gasket

22 MAN 01/EN/00 CRONO S-PID 10/12