CRONO S-PID 50 Ambulatory infusion pump NEW MODEL USER 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 - mailbox@canespa.
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....................................
S E C T I ON 8 Factory settings................................................................. Page 29 SEC TI ON 9 Quick reference................................................................. Page 30 SEC TI ON 10 Pump initialisation............................................................. Pump settings when inserting battery............................... Pump settings sequence with the pump OFF condition.... Setting of end of infusion acoustic signal..........................
Multiple infusion set........................................................... Multiple infusion set parts.................................................. Preparation of the reservoir and insertion into the pump..... Insertion of the reservoir into the pump............................. Pump configuration images for infusions at multiple sites...... Infusion sites..................................................................... Preparing for the infusion...............................................
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.
SECTION 2 INTRODUCTION Thank you for having chosen the ambulatory infusion pump, model: CRONO S-PID 50. This manual has been prepared to enable you to make the best use of the CRONO S-PID 50 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.
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: service@canespa.it.
SECTION 3 INTENDED USE The CRONO S-PID 50 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 liable for the safety 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.
SECTION 3 Do not prime the infusion line when it is connected to the patient, because this could cause an overdose of the pharmaceutical. 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.
SECTION 3 PUMP DESCRIPTION CRONO S-PID 50 is an ambulatory infusion pump for controlled subcutaneous administration of immunoglobulins and drugs in general. CRONO S-PID 50 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 50 uses 50 ml dedicated reservoirs.
SECTION 3 TECHNICAL CHARACTERISTICS Pump dimensions 3.31 x 2.17 x 1.65 in (84 x 55 x 42 mm). 139 g (126.72 g.), including battery. Weight Battery Lithium CR 123A 3V (battery life about 60/80 infusions). with a 50 ml capacity and a “Luer-Lock” Dedicated single use reservoir universal security attachment. Selectable, from 1 to 50 ml in 1 ml Partial volume increments Time Mode (delivery time) Selectable, from 30' to 500 h. Flow rate Mode Selectable, from 0.
SECTION 3 Settings memory All settings are automatically stored in a flash memory which is retained even if the device is left without a battery Display Liquid Crystal Display (LCD - 0.43 x 1.0 in; 11 x 28 mm). Motor Coreless DC motor, the rotation of which is controlled by an infrared system. Settings lock Two configurable levels. Electronic circuit with twin microcontrollers Ensures a more reliable and safer infusion system.
SECTION 4 EQUIPMENT SUPPLIED 1. CRONO S- PID 50 ambulatory infusion pump. 2. Pump carry-case (Code: VAL/05). 3. Elastic belt (Code: CM/01). 4. Fabric case (Code: CM/06). 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 (Code: CA/02). 8. User Guide.
SECTION 5 PUMP PARTS Attachment for the reservoir wings Supporting eyelets of the supporting cord LED Display Buttons Anti-slip grooves Pusher Battery compartment Serial No.
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 acoustic signal confirms that a command is being executed.
SECTION 5 LIQUID CRYSTAL DISPLAY (LCD) The liquid crystal display uses text messages and icons to display useful information about the settings, the operation being performed and any error situations. Four principal digits Arrow icons Two secondary digits Low battery indicator Lock indicator Drop icon Four principal digits of the display Display principal information related to the values of the settings, error information, etc.
SECTION 5 “Low Battery” indicator: Displayed when the battery is nearly dead (see related section on page 21). “Drop” icon: Steady: the decimal point indicator. Flashing: the hour and minute separator. “Arrow” icons: • A downward arrow indicates that the settings of the pump are being programmed. • A flashing right arrow indicates that the setting shown is a flow which is expressed in ml/h.
SECTION 5 LOW BATTERY INDICATOR The presence of the “LOW BATTERY” indicator (not flashing) on the display indicates that the battery is nearly low. If the indicator remains displayed for several consecutive infusions, the “LOW 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.
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 cover of the battery compartment with the appropriate tool supplied, or by using a paper clip 2. Pull back the cover 3. Use the small ribbon strap (which lies under the battery) to facilitate the removal of the battery. 4.
SECTION 5 CRONO CRONO PID PID CR CRO ONNO O PI PID D 1 2 3 4 5 6 23 MAN 01/EN/01 CRONO S-PID 50 02/13
SECTION 6 SETTINGS LOCK The CRONO S-PID 50 pump has 2 access configurations: - L 0 (unlocked): in this configuration you can use the control buttons to access all of the settings and parameters and control all of the operational functions PROG - L 1 (locked): in this configuration you can use the control buttons to control the operational functions (switching on, priming and switching off) but cannot modify any of the settings. When the pump is set to L 1 the display shows the lock indicator .
SECTION 7 ERRORS AND ANOMALIES DISPLAY ACOUSTIC SIGNAL ERROR DESCRIPTION CORRECTIVE ACTION Brief beep. Operation not allowed --- Continuous acoustic signal and flashing LED. Critical problem in the safety system. Press the button. Intermittent acoustic signal repeated approximately every 10 seconds. Anomaly in the motor circuit. Press the button. Intermittent acoustic signal repeated approximately every 10 seconds.
SECTION 7 DISPLAY ACOUSTIC SIGNAL ERROR DESCRIPTION CORRECTIVE ACTION Intermittent acoustic signal repeated approximately every 10 seconds. When a battery is inserted and at the start of every infusion, the pump performs a check of the settings in the memory. If an error is found, the value in error is replaced by the default value, the pump motor is locked and the error is indicated both on the display and audibly. Initialize the pump.
SECTION 7 WARNINGS • Following the display of error message Er,8 and the successive initialisation, the system reverts to the factory settings (see page 29): in this event the pump settings prescribed by the doctor should be re-entered. • Error messages Er,2 and Er,7 are accompanied by the flashing red LED. NOTES • The displayed error messages (from Er,2 to Er,11 and OCCL) are accompanied by an acoustic signal and the system stops.
SECTION 7 INFUSION SET OCCLUSION The pump is designed to recognize when the administration of a pharmaceutical has been interrupted by external means, such as, for example, the kinking of the infusion set tube and consequent occlusion. In these circumstances, the pump stops the infusion: the display indicates that there is an occlusion, accompanied by a brief acoustic signal. The pump then continues beeping every 10 seconds.
SECTION 8 FACTORY SETTINGS The pump is supplied with the following default settings: Delivery time 10 h End of infusion acoustic signal AL on (active) Partial volume 50 ml Access level L 0 (unlocked) Number of infusions 0 In flow rate mode the pump is supplied with the following settings: Flow rate 5 ml/h End of infusion acoustic signal AL on (active) Number of infusion sites IP,1 Partial volume 50 ml Access level L 0 (unlocked) Number of infusions 0 29 MAN
SECTION 9 QUICK REFERENCE The buttons have a built-in safety delay: you must keep them pressed for several seconds before the command takes effect. These quick reference instructions are not an alternative to reading the information in this manual, but give a basic and rapid summary of the pump’s functions. BUTTONS ACTIVATION DISPLAY • Show all display segments BATTERY INSERTION • Show the type of programming (flow rate/time) • Access the flow rate/time selector (only possible with L 0 access level).
SECTION 9 BUTTONS SWITCHING ON DISPLAY • Switching on the pump • Priming phase • Displaying the partial volume (if it has been set) • Displaying the number of infusion sites (only in “F” mode) • Start of infusion PRIMING • Priming dose (max 1.
SECTION 9 PUMP SET TO OFF EARLY WITHDRAWAL OF THE Pusher / NUMBER OF INFUSIONS and press contemporaneously • Interruption of an active infusion, withdrawing the pusher to the start position of the infusion • Number of infusion (PC: Partial Counter) press for 4 seconds BUTTONS start of infusion DISPLAY • Start of infusion • When the pump is in action, the display shows the delivery time.
SECTION 10 PUMP INITIALISATION If the battery is removed when the display shows OFF when you reinsert the battery the pump runs the initialisation sequence, during which it: 1. Runs a self-diagnosis test, emitting a series of brief acoustic signals, flashing the red LED and displaying all the indicators and icons on the screen. 2. The display shows programming mode. the previously selected 3. The display shows OFF. NOTES • The pump is supplied with a new battery already inside the pump.
SECTION 10 PUMP SETTINGS WHEN INSERTING BATTERY If the battery is removed when the display shows OFF when you reinsert the battery you can set the programming mode of the pump: 1 - by flow rate, expressed in ml/h if you select “F” or, 2 - by time, expressed in hours and minutes if you select “t”. Procedure: 1 - Remove the battery when it is in the OFF state and reinsert it. 2 - The display shows all the symbols.
SECTION 10 PUMP SETTINGS SEQUENCE WITH THE PUMP OFF CONDITION When the device is set to OFF, the following parameters can be set: 1 - End of infusion acoustic signal. 2 - Number of infusion sites (feature available only in flow rate mode). 3 - Partial volume. In the OFF state, the parameters can only be selected in the following conditions: - Settings lock unlocked - At the start of a new infusion (partial or total).
SECTION 10 SETTING OF END OF INFUSION ACOUSTIC SIGNAL 1. In the OFF state, by pressing the button: the pump starts the mode for selecting the end of infusion acoustic signal. 2. When the value flashes, select a new value using the and buttons. Selecting OFF disables the warning and the end of infusion acoustic signals; selecting on activates the warning of end of infusion acoustic signals, which will go off 5 mins. and 10 mins. before the end of the infusion, and the end of infusion acoustic signal.
SECTION 10 SETTING THE NUMBER OF INFUSION SITES This function is active only if the pump has been set in flow rate mode. In case it is required to administer a drug volume by dividing it in multiple infusion sites, called Infusion Points (IP), the pump allows you to select up to 5 sites and make partial delivering in succession. To set this parameter, press the button again.
SECTION 10 3 - In this phase, the patient can replace the infusion set, start the pump again by pressing the button, perform the priming, change the infusion site and continue with the infusion. 4 - The pump will proceed in the same manner described above with the next infusion sites, showing End alternating with 2-4, End alternating with 3-4 and eventually End. Dosing of infusions will end and the pusher will be withdrawn to the infusion start position.
SECTION 10 Setting the partial volume The partial volume function is used when the therapy requires an infusion with less than 50 ml. The partial volume can be set from 1 cc to 50 cc in increments of 1 cc. To set this parameter, press the button again while the previous setting is flashing. The partial volume function can only be set before the start of a new infusion, either partial or complete (50 ml). Proceed as follows: 1.
SECTION 10 NOTES • The partial volume setting is automatically stored in the pump’s memory. • At the end of the infusion, the pusher returns to the position corresponding to the partial volume setting. • The partial volume setting can be interrupted by pressing the and buttons simultaneously.
SECTION 10 SETTING THE DELIVERY TIME This function is available only if the “t” (time) function has been selected upon battery insertion. Time value can be set from 30’ to 500 h - From 30 minutes to 1 hours in increments of 5 minutes - From 1 hours to 50 hours in increments of 15 minutes - From 50 hours to 500 hours in increments of 120 minutes (2 hours). You can change the time parameter during an infusion. Procedure: 1 - Switch on the pump by pressing the button.
SECTION 10 SETTING THE FLOW RATE This function is available only if the “F” (flow rate) function has been selected upon battery insertion. Flow rate value can be set from 0.1 ml/h to 100 ml/h - From 0.1 ml/h to 1 ml/h in increments of 0.01 ml/h; - From 1 ml/h to 10 ml/h in increments of 0.1 ml/h; - From 10 ml/h to 100 ml/h in increments of 1 ml/h. You can change the flow rate parameter during an infusion. Procedure: 1 - Switch on the pump by pressing the button.
SECTION 10 SWITCHING ON THE PUMP From the OFF state, press the give a brief beep and display: button. The pump will • Pr (priming function) the display shows Pr.
SECTION 10 PRIMING THE INFUSION LINE The priming function allows filling the infusion line with the drugs contained in the reservoir. The volume available for priming is 1.5 ml. The priming function is enabled when you switch on the device and the pusher is in the infusion start position or at the start of an infusion fraction (Infusion Point), regardless of whether the settings lock is on. The priming procedure is as follows: 1. Turn on the device by pressing the button. 2. The display shows Pr.
SECTION 10 NOTES • If you keep the button pressed, the pump delivers the priming dose, giving an acoustic signal every consecutive delivery of 0.5 ml (i.e. 0.5 – 1.0 – 1.5 ml). • If, after the priming indication is displayed, the buttons are not pressed again for 10 seconds, the display shows OFF. button. The • The priming function can be interrupted by releasing the display shows Pr again , and you again have the choice of postponing, cancelling or performing the priming function as described above.
SECTION 10 END OF INFUSION Ten minutes before the end of the infusion (only if AL is active), the device gives an intermittent acoustic signal lasting 2 seconds. This signal is repeated twice at 5 minutes from the end of the infusion and at the end of it: the display shows the End message. After a few seconds, the pusher starts withdrawing until it reaches the start position of the infusion. When the withdrawal is complete, the display shows OFF and the pump is ready for a further infusion.
SECTION 10 WITHDRAWING THE Pusher 1. Stopping an infusion before the end This function allows the interruption of an active infusion, withdrawing the pusher to the start position of the infusion. To carry out a withdrawal, proceed as follows: • Turn off the pump by pressing the simultaneously. and the buttons and the button simultaneously: the •P ress the display shows End for 10 seconds and then begins to withdraw the pusher.
SECTION 10 NOTE The function to withdraw the pusher can be interrupted and buttons together. The display by pressing the then alternates between End and OFF. At this point only the button is active. When you press again the pump recommences the withdrawal of the pusher. Warning Do not remove the reservoir until the pusher has been withdrawn to the infusion start position.
SECTION 10 SWITCHING OFF THE PUMP To switch off the pump during an infusion, press the and buttons simultaneously; the display will show StoP. the If the pump is switched off during an infusion, the device will emit a series of 10 short beeps every 10 seconds, and the display will flash the StoP message. To interrupt the audible signals, press the button. These indications will be repeated each time the pump is switched off during an infusion.
SECTION 10 Resetting the number of partial infusions The device contains two infusion counters: one which is partial and can be reset and another which shows the total number. To reset the number of partial infusions, proceed as follows: 1 - Press the button for approx. 4 seconds, until the display shows the counter of infusions PC (Partial Counter) 2 - Without releasing the button, press the button.
SECTION 11 Reservoir PARTS The CRONO S-PID 50 pump uses dedicated 50 ml reservoir, model: CRN® CRONO® Syringe. The reservoirs are: single-use, non-pyrogenic and only to be used if the packaging is undamaged. Stem Reservoir body Piston Luer-Lock cap Needle Needle cover Labyrinthine cap Warnings • For safety reasons, you are recommended to use the original CRN® CRONO® Syringe reservoir. • The use of any other type of reservoir could damage the pump and harm the patient. • Canè S.p.A.
SECTION 11 INFUSION SET You are recommended to use an infusion set with the following characteristics: • Low internal volume of tube (ideally 0.1 ml, maximum 0.62 ml) • Tube length not more than 11.43 inch (90 cm) • Anti-kink tubing. INFUSION SET PARTS Female Luer-Lock connector Adhesive Needle Needle cover Tube NOTE The images show the NeriaTM, infusion set from Unomedical, a Convatec Company. Warning Refer to the user guide supplied with the device for information about using the infusion sets.
SECTION 11 Warnings • The Y-SET does not guarantee that the drug is equally distributed in both infusion sites. • Refer to the product sheet supplied with the device for information about using the Y-SET. MULTIPLE INFUSION SET You can use a two-way or multiple infusion set as an alternative to the Y-SET. MULTIPLE INFUSION SETPARTS Female Luer-Lock connector Tube Adhesive NOTE The images show the NeriaTM multi, infusion set produced by Unomedical, a Convatec Company.
SECTION 11 PREPARATION OF THE RESERVOIR AND CONNECTION TO THE PUMP 1. Screw the needle into the reservoir in a clockwise direction and remove the PREPARATION OF THE RESERVOIR needle cover; 2. F ill the reservoir , aspirating the liquid slowly and checking that the quantity of the drug does not exceed its capacity or any partial volume you may have set; 3. S crew the Luer-Lock cap to the reservoir (a) and then unscrew the stem, rotating it counter-clockwise (b) with a fairly rapid movement; 4.
SECTION 11 INSERTION OF THE RESERVOIR INTO THE PUMP Insert the dedicated CRN reservoir into the pump and engage it by rotating it 90° clockwise; a click confirms it has engaged.
SECTION 11 Warning • Before filling the reservoir Unscrew and screw back the piston rod to facilitate its unscrewing after you have filled the reservoir. • Filling the reservoir The liquid must be aspirated slowly. Do not fill the reservoir more than the maximum level allowed. The rod must be unscrewed with a fairly rapid movement.
SECTION 11 PUMP CONFIGURATION IMAGES FOR INFUSIONS AT MULTIPLE SITES: 1 - Y-SET PUMP 2 - TWO-WAY SET PUMP 57 MAN 01/EN/01 CRONO S-PID 50 02/13
SECTION 11 INFUSION SITES The figures below indicate the recommended infusion sites. You are recommended to change the injection site after every infusion to avoid skin irritations. PREPARING FOR THE INFUSION Before preparing for the infusion, you are recommended to adopt the following precautions: 1. Wash your hands 2. Prepare a clean working environment. Warning Always carry out the infusion in antiseptic conditions, to reduce the risk of infection to the minimum.
SECTION 11 The images refer to the NeriaTM infusion set from Unomedical, a Convatec Company. Disinfect the infusion site following the instructions of the relevant medical personnel. Ensure that the area of the infusion site is dry before inserting the subcutaneous needle. Connect the infusion set to the reservoir. Hold the infusion set by the wings. Prime the infusion line manually or use the priming function of the pump. Ensure there are no air bubbles in the infusion line.
SECTION 11 Remove the needle cover, extracting it with care, before inserting the needle. Warning Be careful not to touch the NeriaTM needle when you remove the protection. It is important to lift a fold of skin, to reduce the risk of positioning the needle in a muscle. Pinch the skin with your fingers at the chosen infusion site before inserting the needle, which you do by taking the protective wings of the infusion set with the other hand and inserting the needle vertically.
SECTION 12 HOW TO USE THE ACCESSORIES SUPPLIED The following figures give an indication of how to use the standard equipment supplied with the pump. PUMP CARRIED AROUND THE NECK The pump worn with a collar strap and a fabric case. PUMP ATTACHED AT THE WAIST The pump worn with an elastic belt and a fabric case.
SECTION 13 GENERAL WARNINGS The device can be damaged by liquid, so it must not be kept on while in the bath or the shower, etc. If the device is accidentally made wet, (for example, drops of the drugs, or overnight bedwetting), you must ensure it is checked by the Canè S.p.A. Service Centre The device must be kept away from: - Sources of heat (radiators, gas rings, stoves, etc.) - Direct sunlight - Strong electro-magnetic fields (magnets, loudspeakers, mobile devices) - Details are given in APPENDIX 6.
SECTION 13 MAINTENANCE The technical characteristics of the device make it extremely simple to maintain. If the device is damaged, you are recommended to have it checked by the Canè S.p.A. Customer Support Service, before re-using it. The external surfaces can be cleaned with a lightly dampened soft cloth, using a mild detergent or disinfectant. GENERAL WARNINGS • Do not immerse the pump in detergent solutions or water. • Avoid getting liquids inside the pump.
SECTION 13 SUPPORT The device must only be repaired by the Canè S.p.A. Customer Support Service. You are recommended, before sending the device, to 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 • Canè S.p.A. Online Internet: www.canespa.it - E-mail: service@canespa.
SECTION 13 GUARANTEE Canè S.p.A. guarantees the product from any material or manufacturing defects for a period of 2 (TWO) YEARS from the original date of purchase. If, in the course of this guarantee period, any material or manufacturing defects are identified, Canè S.p.A. will repair or substitute the defective components according to the terms and conditions herein, without any charge for labour or parts; the Customer is responsible for the costs of sending the pump to the Canè S.p.A.
SECTION 13 5. Canè S.p.A. undertakes to perform repairs on the device for a period of not more than 4 (four) years from the date of purchase. After that period, Canè S.p.A. has no further obligations to make repairs. Canè S.p.A. disclaims all responsibility either to the purchaser or to third parties for damage that occurs to persons or things as a result of the use of the device after 4 (four) years from the date of purchase. 6. After the guarantee period is expired, support will be provided by Canè S.
SECTION 14 DECLARATION OF CONFORMITY 0476 The company Canè S.p.A. with headquarters in Via Cuorgnè, 42/a 10098 Rivoli (Turin) - Italy, manufacturer of the medical electrical equipment CRONO S-PID 50 ambulatory infusion pump with "reservoir" for drug administration, Serial No. declares that the device conforms to the essential requirements of Appendix I of Directive 93/42/EEC, modified by Directive 2007/47/ EEC, as per certificate MED 9813 provided by the Notifying Body No.
ENCLOSURES 68 MAN 01/EN/01 CRONO S-PID 50 02/13
APPENDIX 1 ICONS USED ON THE PUMP SN IP 42 Serial No. of the pump IP protection rating 1st digit (4) = protection from solid objects larger than 1 mm. nd 2 digit (2) = protection from water droplets sprayed at an angle (up to 15º degrees from the vertical). CE marking 0476 Medical electrical equipment Electrical classification: Type BF.
APPENDIX 1 ICONS USED ON THE RESERVOIR BLISTER PACK i 0123 Read the instructions CE marking Recyclable 2 Use only once PYROGEN Non-pyrogenic Keep dry Keep away from sunlight Expiry date STERILE EO Sterilised with ethylene oxide PP Polypropylene LOT Batch code REF Reference No.
APPENDIX 2 OPTIONAL ACCESSORIES AVAILABLE ON REQUEST 1. Vertical leatherette case, similar to a mobile phone case. Detail of belt clip Detail of opening system with aperture for infusion set Item code: CM/17/A Colour: black Dimensions: approx. 6.30 x 2.2 x 1,57 inch (16 x 5.
APPENDIX 2 2. Horizontal leatherette case, similar to a spectacle case. Detail of belt clip Item code: CM/22/A Colour: black Dimensions: 6.3 x 2.2 x 1.57 inch (16 x 5.5 x 4 cm) Weight: Approx.
APPENDIX 3 PRECISION TESTS The tests have been performed according to IEC 60601-2-24, Electro-medical devices, Part 2: Particular requirements for the safety of infusion pumps and controllers. The following graphs show the precision of the pump during the administration of the pharmaceutical. Flow rate [ml/h] 1.1 – Start-up flow Flow rate setting: 1 ml/h.
APPENDIX 3 TRUMPET CURVE Percentage flow rate error 1.2 – Flow rate error (trumpet curve) Flow rate setting: 1 ml/h. Observation interval (mins.) The degree of precision can be different from the information in this manual, according to the type of accessories and extension tubes used in the administration line of the drug.
APPENDIX 3 PRECISION TESTS Flow rate [ml/h] 2.1 – Start-up flow Flow rate setting: 25 ml/h.
APPENDIX 3 TRUMPET CURVE Percentage flow rate error 2.2 – Flow rate error (trumpet curve) Flow rate setting: 25 ml/h. Observation interval (mins.) The degree of precision can be different from the information in this manual, according to the type of accessories and extension tubes used in the administration line of the drug.
APPENDIX 3 PRECISION TESTS Flow rate [ml/h] 2.1 – Start-up flow Flow rate setting: 50 ml/h.
APPENDIX 3 TRUMPET CURVE Percentage flow rate error 2.2 – Flow rate error (trumpet curve) Flow rate setting: 50 ml/h. Observation interval (mins.) The degree of precision can be different from the information in this manual, according to the type of accessories and extension tubes used in the administration line of the drug.
APPENDIX 4 TIME NEEDED TO SIGNAL AN OCCLUSION APPENDIX 2 The time needed to signal an occlusion is the interval between the beginning of the occlusion condition and the recognition of the condition by the pump. This value depends on the flow rate, because the lower the flow rate, the longer the time needed by the pump to recognise the occlusion condition. The values given here consider the time needed jointly by the pump and the reservoir to signal the occlusion.
APPENDIX 5 POST-OCCLUSION BOLUS When the occlusion alarm sounds, the pump has detected an excessive back pressure in the infusion line. This back pressure must be removed in order to avoid releasing a post-occlusion bolus, which might cause serious harm to the patient. The volume of a CRONO S-PID 50 post-occlusion bolus, considering only the combined volume of the pump and the reservoir is about 1.8 ml.
APPENDIX 6 ELECTRO-MAGNETIC COMPATIBILITY The electro-magnetic compatibility tests were performed in compliance with the standards: • I EC 60601-2-24:2012, Medical electrical equipment, Part 2: Particular requirements for the safety of infusion pumps and controllers. • IEC EN 60601-1-2 Ed. 2, Medical electrical equipment, Part 1: General requirements for basic safety and essential performance – collateral standard: Electro-magnetic compatibility – Requirements and tests.
APPENDIX 6 Guide and declaration by the manufacturer - electro-magnetic immunity CRONO S-PID 50 is designed to operate in the electro-magnetic environment specified below. The customer or user of the CRONO S-PID 50 must ensure that it is operated in such an environment.
APPENDIX 7 REFERENCE DIRECTIVES • Council Directive 93/42/EEC: Medical devices. • L egislative Decree no. 46, 24th February 1997: Implementation of Council Directive 93/42/EEC concerning medical devices.
APPENDIX 7 TECHNICAL STANDARDS • I EC EN 60601-1:2007-05. Medical electrical equipment, Part 1: general requirements for basic safety and essential performance. • I EC EN 60601-1/EC:2010-05. Medical electrical equipment, Part 1: general requirements for basic safety and essential performance. • I EC EN 60601-1-1:2003-06. Medical electrical equipment, Part 1: general requirements for basic safety and essential performance – collateral standard: Safety requirements for electro-medical systems.
APPENDIX 7 • C EI 62-108: 2000-05. Guide to the maintenance of infusion pumps and control systems. • I EC EN 62353:2008-11. Medical Electrical Equipment - recurrent checks and test after repair of medical electrical equipment. • C EI 62-122: 2002-07. Guide to acceptance testing and periodic maintenance of the safety and / or performance of medical devices powered by a specific power source. • C EI 62-143: 2007-05.
APPENDIX 8 INFORMATION For further information about the CRONO S-PID 50 pump, contact: 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 Internet: www.canespa.it e-mail: service@canespa.
APPENDIX 8 87 MAN 01/EN/01 CRONO S-PID 50 02/13
