CRONO S-PID 50 User Guide Firmware ver S5P.02.00 June 2009

US Federal law restricts this device for sale by or on order of a physician.

Manual code: MAN 01/USA/02 S-PID 50 Date of publication: 06/09 Firmware version: S5P.02.00 Firmware date: 18/10/07

INDEX SECTION 1 Symbols and conventions... CAUTION... Introduction...

page 7 page 7 page 8

SECTION 2 Intended use... WARNING...

page 10 page 10

SECTION 3 Infusion system... Description of the pump... Technical characteristics...

page 12 page 12 page 13

SECTION 4 Factory settings... Information...

page 15 page 15

SECTION 5 Equipment... Optional accessories available on request... How to use the accessories provided...

page 16 page 17 page 20

SECTION 6 Identifying the device components... Liquid crystal display... Examples of indications appearing on the display... Keypad...

page 21 page 22 page 23 page 25

SECTION 7 Reservoir... Luer Lock cap... Profill-crn needle... Filtrajet... Y-set...

page 26 page 27 page 27 page 28 page 28

MAN 01/USA/02 S-PID 50 06/09

3

INDEX

4

Infusion set... Identifying the infusion set components... Infusion preparation... Preparing the reservoir... Attaching the reservoir to the device...

page 29 page 29 page 29 page 30 page 32

SECTION 8 Keypad lock... Warning...

page 35 page 35

SECTION 9 Initialization of the pump...

page 36

SECTION 10 Setting and inserting the battery... Setting in the OFF condition ... Flow chart of settings in the OFF conditions... Infusion end acoustic signal ... Setting the number of infusion sites... Setting the partial volume... Settings in the ON condition ... Setting the infusion duration... Flow rate setting...

page 37 page 38 page 39 page 40 page 40 page 42 page 44 page 44 page 45

SECTION 11 Switching on the pump in time mode... Switching on the pump in flow rate mode... Pump in operation... Infusion set refilling (Prime)... Withdrawal... Pushing unit movement... Occlusion... Post-Occlusion Bolus...

page 46 page 47 page 48 page 48 page 50 page 50 page 52 page 52

MAN 01/USA/02 S-PID 50 06/09

Infusion end... Switching off... Infusion number display ... Saving set data...

page 53 page 54 page 54 page 54

SECTION 12 Battery low warning... Replacing the battery... BATTERY CARE...

page 55 page 56 page 58

SECTION 13 GENERAL WARNINGS...

page 59

SECTION 14 Manual updates... Maintenance ... Cleaning... GENERAL WARNINGS... Storage... Disposal... Expected life of the pump...

page 60 page 60 page 60 page 60 page 60 page 61 page 61

SECTION 15 Customer Support... Warranty regulations...

page 62 page 62

SECTION 16 Error signals... Customer Support Service...

page 64 page 65

SECTION 17 Instructions in short...

page 66

MAN 01/USA/02 S-PID 50 06/09

5

6

SECTION 18 Symbols on the pump... Symbols on the syringe blister package...

page 70 page 71

SECTION 19 Declaration of compliance...

page 72

ATTACHMENTS Attachment 1... Attachment 2... Attachment 3...

page 73 page 75 page 76

MAN 01/USA/02 S-PID 50 06/09

SECTION 1 SYMBOLS AND CONVENTIONS To make consulting this manual easier the following symbols and conventions have been adopted: Triangle with an exclamation mark This “Warning” icon signals information that must always be considered to use the pump safely. Note pad This icon indicates “Notes”, additional information or useful suggestions to use the pump. The OFF condition or pump in the OFF position means the pump is switched off and not delivering. The ON condition or pump in the ON position means the pump is switched on and is operating/delivering.

CAUTION US Federal law restricts this device for sale by or on order of a physician.

MAN 01/USA/02 S-PID 50 06/09

7

SECTION 1 INTRODUCTION Thank you for choosing the CRONO S-PID 50 ambulatory infusion pump. This manual was written to ensure the optimal use of the pump. The instructions contained in this manual only concern the CRONO S-PID 50 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 35) 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 or unauthorized changes to the selected parameters; in cases in which it is appropriate for the patient not to know this procedure, the doctor 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 commissioning. Canè S.p.A. reserves the right to modify the hardware and software specifications described in this manual at any time and without warning.

8

MAN 01/USA/02 S-PID 50 06/09

SECTION 1 NOTES Canè S.p.A. reserves the right to modify and/or update this manual at any time and without warning. With the purpose of making this manual complete and precise, please notify us of any errors or omissions at the following email address: [email protected].

MAN 01/USA/02 S-PID 50 06/09

9

SECTION 2 INTENDED USE The CRONO S-PID 50 ambulatory infusion pump has been designed exclusively for subcutaneous immunoglobulin infusions. Administration of medication with other methods and therapies shall exempt Canè S.p.A. from any responsibility.

NOTE 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.

WARNING Improper programming and/or the incomplete understanding of operating functions and alarms may cause death or serious injuries to the patient. Before using the pump assess its suitability for the type of use and the patient by carefully considering the following aspects: - the technical specifications of the pump; - the infusion sets that will be used; - any use of multiple infusion sets and clamps along the infusion line; - the type of therapy in the treatment of primitive immunodeficiency, which the patient is undergoing; - the psychophysical and cognitive conditions of the patient. The list above is not exhaustive and is provided for purposes of example only, with regard to the clinical procedural aspects, the responsibility of which is borne by the medical or paramedical personnel. The device must be used: • under strict medical control, • adopting suitable procedures and adequate measures towards those patients who may suffer serious consequences (injury or death) following involuntary operations and/or breakdowns with the consequent interruption in the administration of the medication. 10

MAN 01/USA/02 S-PID 50 06/09

SECTION 2

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. After inserting the needle check, by means of suction, that it has not been introduced into a vein or in a capillary (for further details on the procedure to use, please refer to your family doctor). The accuracy and the amount of time necessary to signal an occlusion 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. In case of suspected damage to the pump for any reason (for example due to infiltration of liquid or bangs), contact the Customer Support Service to ascertain the correct operation of the pump. Do not use the pump if damaged. For doubts concerning the operation of the pump and/or in case of anomalies, interrupt the use of the device and contact the technical assistance service. Any trace of liquid on the outer part of the pump must be immediately removed with paper towels. It is important to arrange a procedure and/or system as an alternative to that of the infusion through a pump in case this breaks. A valid solution may be to arrange both a second pump and an alternative system to it. It is worthwhile that the people who assist and/or live with the user of the pump know how the pump works and the information contained in the instruction manual. It is important to interrupt the use of the device after its forecast service life following the instructions for its correct disposal.

MAN 01/USA/02 S-PID 50 06/09

11

SECTION 3 INFUSION SYSTEM For a better absorption of the medication the pump administers 20 µl doses at intervals that depend on the set flow rate. The time interval between doses decreases proportionally as the programmed flow rate increases or the time decreases.

DESCRIPTION OF THE PUMP The CRONO S-PID 50 is an ambulatory syringe infusion pump intended for the controlled subcutaneous administration of medication. The CRONO S-PID 50 uses specific 50 ml syringes called reservoirs. The CRONO S-PID 50 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 recreational activities during the infusion. The main features of the pump are: - the possibility of selecting the time or flow rate programming mode; - the possibility of fractionating the volume of the medication contained in the syringe in more than one infusion site (in flow rate mode). The precision of the progression mechanism, which acts directly on the piston of the syringe, allows the pump to administer the medication accurately. The CRONO S-PID 50 is equipped with a liquid crystal display showing the doctor and patient useful information concerning the pump’s programming, operation and diagnostics.

12

MAN 01/USA/02 S-PID 50 06/09

SECTION 3 TECHNICAL CHARACTERISTICS Size Weight Battery

Reservoir

Administration volumes Time mode (Infusion duration) Flow rate mode Setting the number of infusion sites (only in flow rate mode) Flow rate accuracy Occlusion pressure Occlusion signaling time Post-occlusion bolus Electronic circuit Data storage

Display

MAN 01/USA/02 S-PID 50 06/09

84.5 x 55 x 42 mm. 140 g (battery included). CR 123A 3V Lithium (approx. 3/6 months battery life - 60/80 infusions). Specific with a 50 ml capacity and a “luer-lock” universal safety attachment. Selectable from 5 to 50 ml at 1 ml stages. Selectable from 1 to 50 h with 15’ stages. Programmable from 1 ml/h to 50 ml/h at 1 ml/h stages. Selectable from 1 to 5 sites. +/-3%. 3 bars +/-1.5. See ATTACHMENT 2. About 1.8 ml. Managed by a microcontroller with dedicated software. The values selected are automatically stored in a memory that saves them even when the battery is removed. Liquid crystal.

13

SECTION 3

Motor

Keypad lock Safety circuits

Operating Conditions

Storage conditions

14

Coreless direct current motor. The microcontroller manages the rotation through an infrared encoder. Two levels can be set. They control the correct operation by intervening in case of faults with acoustic signals and messages on the display. +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/02 S-PID 50 06/09

SECTION 4 FACTORY SETTINGS In time mode, the pump is supplied with the following settings: Infusion duration Infusion end acoustic signal Partial volume Access level

10 h AL,1 (active) 50 ml L 0 (complete)

Number of infusions

0

In the flow rate mode the following parameters are set: Flow rate Infusion end acoustic signal Number of infusion sites Partial volume Access level

5 ml/h AL,1 (active) IP,1 50 ml L 0 (complete)

Number of infusions

0

INFORMATION For further information about the CRONO S-PID 50 pump contact:

IntraPump Infusion Systems® UNITED STATES 920 Minters Chapel Road, Suite 200 Grapevine, TX 76051 Tel: 866-211-7867 Fax: 630-845-2768 Email: [email protected] MAN 01/USA/02 S-PID 50 06/09

15

SECTION 5 EQUIPMENT 1. CRONO S-PID 50 portable syringe pump. 2. Infuser holder case (Code: VAL/03). 3. Elastic belt (Code: CM/01). 4. Support cord (Code: CM/18D). 5. Fabric case (Code: CM/02). 6. 2 batteries (1 of which is inside the pump) (Code: CR/123A). 7. Instruction manual. 8. Accessory battery compartment door opener (Code: CA/02).

2

7

8 5

1

3 6

16

4

MAN 01/USA/02 S-PID 50 06/09

SECTION 5 OPTIONAL ACCESSORIES AVAILABLE ON REQUEST 1. Heightwise leatherette case similar to a cellular phone holder.

Detail belt clip

Detail opening Color: black Size: 12 x 5.5 x 4 cm Weight: about 60 g Article code: CM/11

MAN 01/USA/02 S-PID 50 06/09

17

SECTION 5

2. Lengthwise leatherette case similar to a glasses case.

Detail of belt loop

Color: black Size: 12 x 5.5 x 4 cm Weight: About 50 g. Article code: CM/10

18

MAN 01/USA/02 S-PID 50 06/09

SECTION 5

3. Specific hard case with prime button that can be activated from the outside, a window that allows you to see the display and black elastic belt.

Color: semitransparent upper casing, blue lower casing. Size: 12 x 5.5 x 4 cm Weight: About 75 g. Article code: CM/12

MAN 01/USA/02 S-PID 50 06/09

19

SECTION 5 HOW TO USE THE ACCESSORIES PROVIDED The figures below provide indications on the use of the accessories supplied with the pump. PUMP WORN AROUND THE NECK Pump worn with the support cord and the fabric case.

10 20 30 40 50 l m

PUMP WORN AROUND THE WAIST Pump worn with the elastic belt and the fabric case.

20

MAN 01/USA/02 S-PID 50 06/09