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FDE SO-CONNECT PID User Manual

Ambulatory infusion pump
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Ambulatory infusion pump
User's manual (EN)

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  • Page 1 Ambulatory infusion pump User’s manual (EN)

  • Page 3: Table Of Contents

    Table of contents About this manual ....................................................5 Safety rules ......................................................6 Part I – Description of pump and accessories ......................................... 8 Description of the pump................................................9 Contraindications ..................................................10 Symbols and labelling.................................................. 10 Compliance and classification..............................................12 Pump box ......................................................13 Optional accessories ...................................................
  • Page 4 Function reserved for medical staff Visualization of the internal information of the pump – ....................52 Part VI – Alarms ....................................................54 Alarm system ....................................................55 Device failure alarm (high priority) ............................................56 Syringe missing alarm (high priority) ........................................... 56 Infusion about to end alarm (low priority) ........................................

  • Page 5: About This Manual

    About this manual This user’s manual is intended for you, who are a patient or a healthcare professional. It contains all the information required for the safe and effective use of the SO CONNECT PID ambulatory infusion pump. Regardless of your experience of ambulatory infusion pumps, please read ♥...

  • Page 6: Safety Rules

    Safety rules This chapter contains important safety instructions that must be read before using the SO CONNECT PID pump. ♥ For safety information regarding the individual functions of the SO CONNECT PID pump, refer to the corresponding section of the ♥...
  • Page 7 Warning Avoid contact of the infusion pump with medication or hygiene items (for example antiseptics, antibiotic creams, soaps, perfumes, ▪ deodorants, body lotions or other cosmetic products). These may cause discoloration of the infusion pump or damage the display. Keep the battery away from fire. ▪...

  • Page 8: Part I - Description Of Pump And Accessories

    Part I – Description of pump and accessories This part of the user’s manual contains the following information: pump description, ▪ contraindications, ▪ symbols and labelling, ▪ compliance and classification, ▪ emergency kit, ▪ pump box, ▪ optional accessories, ▪ using the case, ▪...

  • Page 9: Description Of The Pump

    Partie I – Description of pump and accessories Description of the pump The SO CONNECT PID pump is an ambulatory infusion pump that is intended for the controlled subcutaneous administration of : ♥ SCIg as part of the treatment of PIDs (Primary Immunodeficiency Disorders). It uses 20 ml, 30 ml or 50 ml SO FILL sterile single-use ▪...

  • Page 10: Contraindications

    Partie I – Description of pump and accessories Remark France Développement Electronique shall only be liable for the safety and proper working of the pump if it is CONNECT PID ▪ ♥ used in accordance with these instructions and if any repairs or modifications have been carried out exclusively by France Développement Electronique.
  • Page 11 Partie I – Description of pump and accessories Symbol Description Location Sterilisation process (ethylene oxide). - syringe packaging Not to be reused. - syringe packaging Not to be sterilised again. - syringe packaging LATE Does not contain latex. - syringe packaging Manufacturing batch identification (year, month).

  • Page 12: Compliance And Classification

    Partie I – Description of pump and accessories Compliance and classification This manual has been prepared in accordance with the requirements of standard IEC 60601-2-24 relating to medical electrical equipment – Part 2-24: Particular requirements for the safety of infusion pumps and controllers. The data stated in part VI - Technical specifications - are based on the specific test conditions defined in that standard.

  • Page 13: Pump Box

    Partie I – Description of pump and accessories Pump box When you first open the box containing the SO CONNECT PID pump, please examine each component carefully for damage. ♥ CONNECT PID pump (part: SO CONNECT PID) ♥ ♥ ♥ 2 VARTA EZPack L batteries (part: SO BATTERY) ♥...

  • Page 14: Optional Accessories

    Partie I – Description of pump and accessories Optional accessories  T-shirt Black Lycra Size XS/S part: TSSMALLBLACK Black Lycra Size M/L part: TSMEDIUMBLACK  Bra pouch Black Lycra part: POUCHUNDERWEAR  Neoprene case for 20 ml SO FILL syringe ♥...
  • Page 15 Partie I – Description of pump and accessories Red (girl) part: N50REDG  Imitation leather case for 20 ml SO FILL syringe ♥ Anthracite grey part: L20WGREY Black part: L20WBLACK  Imitation leather case for 30 ml or 50 ml SO FILL syringe ♥...

  • Page 16: Using The Case

    Partie I – Description of pump and accessories Using the case The protective case protects the SO CONNECT PID pump from splashing liquids and impacts when it is in use. It also protects the SO FILL ♥ ♥ syringe. Warning The materials used for the protective cases have not been tested for biocompatibility with the skin.

  • Page 17: Pump Component Identification

    Partie I – Description of pump and accessories Pump component identification The images below show the most important components of the SO CONNECT PID pump. ♥ Pusher Touchscreen Identification label ON/OFF button Cover of battery compartment ON/OFF button ▪ The ON/OFF button is used to switch the screen on and off. Pump status indicator ▪...

  • Page 18: Battery

    Partie I – Description of pump and accessories Date Time Battery level Cancel and return Confirm and go to to previous screen next screen Warning If the screen displays incomplete characters, digits or symbols, remove the battery for a few seconds and put it back in place. If the ▪...

  • Page 19: Battery Charger

    Partie I – Description of pump and accessories Battery charger The battery charger supplied with the SO CONNECT PID pump can recharge the VARTA EZPack L batteries. ♥ The battery charger specifications are as follows: Model number MASCOT Type 3745 Rated AC voltage 90 –...

  • Page 20: Part Ii - Starting The Pump

    Part II – Starting the pump This part of the user’s manual contains the following information: battery charging, ▪ inserting the battery. ▪ Precautions The batteries are delivered uncharged. You must therefore charge them completely before using them. ▪...

  • Page 21: Battery Charging

    Partie II – Starting the pump Battery charging When you need to recharge a battery, please follow the instructions below: First connect the power cord to the charger, then to the power socket. ▪ Insert the battery in the charger. The battery label must be turned towards the front of the charger. ▪...

  • Page 22: Inserting The Battery

    Partie II – Starting the pump Inserting the battery Before using the SO CONNECT PID pump for the first time, you need to charge the battery. ♥ The cover of the battery compartment holds the battery in position. Slide the cover by hand to remove it and put it back. Precautions Do not use a knife, screwdriver or other pointed object to remove the battery compartment cover, as that could damage the ▪...

  • Page 23: Part Iii - Pump Programming

    Part III – Pump programming This part of the user’s manual contains the following information: password entry, ▪ setting up the pump, ▪ setting up and infusion, ▪ pump initialization. ▪...

  • Page 24: Password Entry

    Partie III – Pump programming Password entry Access to the functions reserved for medical personnel is only possible after they enter a password. The SO CONNECT PID pump displays the numeric keypad for entering the password. ♥ Press “ ” to return to the previous screen. ▪...
  • Page 25 Partie III – Pump programming The pump setup (date, time, date format, language) is carried out from the main screen. Press “ ” to open the menu for additional functions. ▪ Press “Parameters”. ▪ The pump will display the first setup tab (Time, Date and Date format). Press “...
  • Page 26 Partie III – Pump programming Use the keypad for entering the new time. ▪ Press “ ” to cancel and return to the previous screen. ▪ Press “ ” to confirm the new time and return to the previous screen. ▪...
  • Page 27 Partie III – Pump programming Use the keypad for entering the date. ▪ Press “ ” to confirm and return to the previous screen. ▪ Press “ ” to cancel and return to the previous screen. ▪ Warning Setting the correct date is crucial. Clinical data management is dependent on this setting. If the time zone is changed, make sure the ▪...

  • Page 28: Setting Up An Infusion

    Partie III – Pump programming Setting up an infusion Warning Before setting up a new infusion, check that the date and time are correct. The infusion rates and clinical data are saved based on ▪ this information. Incorrect date and time settings can result in the incorrect administration of apomorphine. Comments To simplify the process of setting up a new infusion, the pump always displays the setup of the previous...
  • Page 29 Partie III – Pump programming Comments To simplify the process of setting up a new infusion, the pump always displays the setup of the previous CONNECT PID ▪ ♥ infusion. Step 1 : patient information The SO CONNECT PID pump has a function for saving patient information. That information is used while exporting clinical data to the ♥...
  • Page 30 Partie III – Pump programming Entering the surname When the pump displays the patient information screen, press the surname to modify it. CONNECT PID wil display the alphabetical keypad for intering the patient’s surname. It may ♥ have no more than 16 characters. Use the keypad to enter the surname.
  • Page 31 Partie III – Pump programming CONNECT PID pump will display a numeric keypad for entering the patient’s date of birth. ♥ Use the keypad to enter the date of birth. ▪ Press “ ” to cancel and return to the previous screen. ▪...
  • Page 32 Partie III – Pump programming Entering the residual rate CONNECT PID displays the patient information screen. Press the residual rate to modify it. ♥ CONNECT PID pump will display a numeric keypad to enter the residual rate. ♥ Use the keypad to enter the residual rate. ▪...
  • Page 33 Partie III – Pump programming Selecting the type of syringe CONNECT PID pump displays the screen for the type of syringe and the volume to infuse. ♥ CONNECT PID displays the list of compatible syringes. ♥ Press the type of syringe used for the infusion. ▪...
  • Page 34 Partie III – Pump programming Step 3 : entering the flow rate or the duration of the infusion CONNECT PID pump displays the screen of the flow rate and the duration of the infusion. Press ♥ on the flow rate to modify it. Entering the flow rate.

  • Page 35: Pump Initialization

    Partie III – Pump programming Pump initialization The patient information as well as the infusion parameters can be deleted by using the initialization function. Press “ ” to open the menu for additional functions. ▪ Press “Initialization”. ▪ The pump will display the first setup tab (Time, Date and Date format). Press “Initialization”...

  • Page 36: Part Iv - Syringe And Infusion Set

    Part IV – Syringe and infusion set This part of the user’s manual contains the following information: FILL syringes ▪ ♥ infusion set. ▪...

  • Page 37: Syringe

    Partie IV – Syringe and infusion set Syringe Body of the syringe Plunger Luer-Lock fitting Guide Seal Safety needle Warning Only use . Using other may damage the ♥ pump and cause serious injury to the FILL syringes syringes CONNECT PAR ®...
  • Page 38 Partie IV – Syringe and infusion set Filling the syringe To fill the SO FILL syringe, please follow the steps below: ♥ Unscrew and screw the plunger so that it can be unscrewed easily after filling the syringe. Check the correct “tightening” between the plunger and the piston. Push the plunger back and forth to uniformly lubricate the silicone inside the body of the SO FILL syringe.
  • Page 39 Partie IV – Syringe and infusion set Verify that the quantity of liquid does not exceed the capacity of the SO FILL syringe or the defined volume. ♥ If you used the safety needle, after filling the SO FILL syringe, clip the protective cap to avoid injury. ♥...

  • Page 40: Infusion Set

    Partie IV – Syringe and infusion set Connecting the syringe to the pump ♥ To connect the SO FILL syringe to the SO CONNECT PAR ® pump, please follow the steps below: ♥ ♥ Turn the head of the pusher on the SO CONNECT PAR ®...
  • Page 41 Partie IV – Syringe and infusion set Putting in place the infusion set The infusion set is to be put in place as follows: Remove the adhesive tape. Remove the needle guard. Pinch the skin with one hand and insert the infusion set vertically. Press the adhesive to fix the infusion set on the skin.

  • Page 42: Partie V - Infusion

    Partie V – Infusion This part of the user’s manual contains the following information: starting an infusion ▪ infusion control screen ▪ infusion control menu ▪ pausing the infusion ▪ restarting the infusion ▪ modifying the flow rate or the duration of the infusion ▪...

  • Page 43: Starting An Infusion

    Partie V – Infusion Starting an infusion Warning Before starting an infusion, check that the date and time are correct. The clinical datas are saved based on this information. ▪ Precautions Do not position the syringe on the pump until it invites you to do so. This could cause the pump to malfunction and trigger an ▪...
  • Page 44 Partie V – Infusion Step 3: positioning the pusher After confirming the flow rate or the duration of the infusion, SO CONNECT PID pump positions the ♥ pusher automatically. This operation can take several minutes. Press “ ”to return to the previous screen. ▪...

  • Page 45: Infusion Control Screen

    Partie V – Infusion Infusion control screen During the infusion, the SO CONNECT PID pump displays information about its status. ♥ Current infusion rate Remaining volume Remaining time Infusion control menu Warning During the infusion, check the working of the pump from time to time. If you observe any malfunctioning or poor performance, ▪...

  • Page 46: Pausing The Infusion

    Partie V – Infusion When the infusion is paused, press “ ” to access to the infusion control menu. ▪ The SO CONNECT PID pump displays the first page of the infusion control menu. ♥ Press “ ” or “ ” to display the second page of the infusion control menu. ▪...

  • Page 47: Restarting The Infusion

    Partie V – Infusion The SO CONNECT PID pump will pause the infusion. ♥ When the infusion is paused, the circle flashes green / yellow. Restarting the infusion You can restart a paused infusion. Press “ ” for two seconds. ▪...

  • Page 48: Modifying The Infusion Rates - Function Reserved To Medical Staff

    Partie V – Infusion Modifying the infusion rates – Function reserved to medical staff Warning The functions described in this chapter should only be used by trained medical personnel when using the pump. The use of these ▪ functions by an untrained user can cause serious injury to the patient. The SO CONNECT PID pump makes it possible to adjust the infusion rate during infusion.
  • Page 49 Partie V – Infusion Modifying the flow rate The SO CONNECT PID pump displays the screen to modify the flow rate or the duration of the ♥ infusion. Press the flow rate to modify it. The SO CONNECT PID pump displays the screen to enter the flow rate. ♥...

  • Page 50: End Of Infusion

    Partie V – Infusion End of infusion Stopping the infusion The SO CONNECT PID pump displays the first screen of the infusion control menu. ♥ Press “End of infusion” for 2 seconds. ▪ The SO CONNECT PID pump displays a confirmation message. ♥...

  • Page 51: Unwanted Effects

    Partie V – Infusion End of infusion At the end of the infusion, the SO CONNECT PID pump generates an alarm. ♥ Press “OK”, for 2 seconds, to acknowledge the alarm. ▪ After acknowledgment, the SO CONNECT PID pump displays the screen requesting removal of the ♥...

  • Page 52: Exporting Clinical Data - Function Reserved For Medical Staff

    Partie V – Infusion Function reserved for medical staff Exporting clinical data – Warning The functions described in this chapter should only be used by trained medical personnel when using the pump. The use of these ▪ functions by an untrained user can cause serious injury to the patient. The SO CONNECT PID pump provides the ability to export clinical data even while an infusion is in progress.
  • Page 53 Partie V – Infusion The SO CONNECT PID pump displays the second page of the infusion control menu. ♥ Press “Software Info.” for 2 seconds. ▪ The SO CONNECT PID pump displays the internal information screen. ♥ Press “ ” Or “ ” to return to the infusion control screen. ▪...

  • Page 54: Part Vi - Alarms

    Part VI – Alarms This part of the user’s manual contains the description of the different alarms emitted by the CONNECT PID pump; ♥ alarm system, ▪ device failure alarm, ▪ missing alarm, syringe ▪ infusion about to end alarm, ▪...

  • Page 55: Alarm System

    Titre VI – Alarmes Alarm system The table below summarises all the conditions in which the different alarms are generated. Alarm Priority Conditions of triggering Triggering period Device failure High Failure of a printed circuit board component detected 1 min. and 30 sec. by the internal software of the SO CONNECT PID ♥...

  • Page 56: Device Failure Alarm (High Priority)

    Titre VI – Alarmes Device failure alarm (high priority) The SO CONNECT PID pump regularly checks if it is operating correctly. If a fault is found in any of ♥ its components, the SO CONNECT PID pump generates a device failure alarm. ♥...

  • Page 57: End Of Infusion Alarm (High Priority)

    Titre VI – Alarmes End of infusion alarm (high priority) At the end of the infusion, the SO CONNECT PID pump generates an alarm. ♥ Occlusion alarm (high priority) The SO CONNECT PID pump generates an occlusion alarm when it detects excess pressure in the ♥...

  • Page 58: Infusion In Pause (Low Priority)

    Titre VI – Alarmes Infusion in pause (low priority) The SO CONNECT PID pump has a function for reminding the patient that the infusion has been ♥ paused for more than 5 minutes. The infusion is not stopped when this alarm is generated.

  • Page 59: Part Vii - General Recommendations, Maintenance, Disposal, Terms Of Guarantee And Declaration Of Conformity

    Part VII – general recommendations, maintenance, disposal, terms of guarantee and declaration of conformity This part contains information about the following: Cleaning and disinfection of the pump, ▪ pump inspection, ▪ maintenance, ▪ alarm system testing, ▪ pump damage in the event of a fall or impact, ▪...

  • Page 60: Cleaning And Disinfection Of The Pump

    Partie VII – Entretien, maintenance, élimination, garantie Cleaning and disinfection of the pump Take the opportunity of a replacement of the SO FILL, for example, to clean the SO CONNECT PID pump. To do so, use a soft dry cloth to ♥...

  • Page 61: Pump Inspection

    Partie VII – Entretien, maintenance, élimination, garantie Pump inspection It is crucial for the SO CONNECT PID pump to be in good working order to guarantee correct administration of medication. Check the pump ♥ screen at regular intervals during the day and when you go to bed, especially if you are unable to hear the sound signals for any reason. Check your pump every day: Make sure that the pump housing, screen and the SO FILL syringe do not show any damage or cracks and that the screen does not...

  • Page 62: Pump Damage In The Event Of A Fall Or Impact

    Partie VII – Entretien, maintenance, élimination, garantie Warning If no alarm is activated, contact user support. ▪ Pump damage in the event of a fall or impact The pump may be damaged in the event of a fall or impact. Remember to use the case that has been designed especially for the SO CONNECT ♥...

  • Page 63: Pump Coming In Contact With Water

    Partie VII – Entretien, maintenance, élimination, garantie Pump coming in contact with water Precautions pump is not sealed. Use the case supplied with your pump to protect it from accidental splashing with CONNECT PID ▪ ♥ water. Avoid all contact with water. Remember to disconnect and remove it before you have a bath or a shower, enter a Jacuzzi or go ▪...

  • Page 64: Storing The Pump

    Partie VII – Entretien, maintenance, élimination, garantie Storing the pump If you do not intend to use the SO CONNECT PID pump for a long period of time, store it in an appropriate manner so as to avoid any ♥ subsequent malfunctioning.

  • Page 65: Guarantee Conditions

    Partie VII – Entretien, maintenance, élimination, garantie Guarantee conditions France Développement Electronique hereby guarantees that the product is free from all material or workmanship defects for a period of 2 (two) years from the date of purchase. If any material or workmanship defects are found during said guarantee period, France Développement Electronique shall be responsible for repairing or replacing the defective components on the terms and within the time frame stated below, without charging for labour or spare parts;...

  • Page 66: Part Vii - Technical Specifications

    Part VII – Technical specifications The information contained in this part is intended for all users: patients and medical personnel. This part contains information about the following: declaration of conformity, ▪ pump specifications, ▪ pump precision, ▪ pressure level, ▪ time required for reporting an occlusion, ▪...

  • Page 67: Declaration Of Conformity

    Partie VIII – Caractéristiques techniques Declaration of conformity...

  • Page 68: Pump Specifications

    Partie VIII – Caractéristiques techniques Pump specifications Pump dimensions 70.5 x 65 x 34.5 mm Pump weight 146 g (battery included) Battery VARTA EZPack L 3.7V 1200 mAh 4.5 Wh Battery life 2 infusions Battery lifespan > 500 cycles (>70% of initial capacity) Disposable syringe FILL 20 ml / SO FILL 30 ml / SO...

  • Page 69: Pump Precision

    Partie VIII – Caractéristiques techniques (1) Battery life has been verified in the laboratory under the following operating conditions: 50 ml infusion at a flow rate of 20 ml / h ▪ 50 ml infusion at a flow rate of 5 ml / h ▪...

  • Page 70: Niveau De Pression

    Partie VIII – Caractéristiques techniques Infusion rate error (trumpet curve) Programmed infusion rate: 2 ml/h Erreur de débit Fenêtre d'observation (en min) Ep(max.) Ep(min.) Erreur globale Zéro Niveau de pression Le niveau de pression d’occlusion est de 1,5 bar. Temps nécessaire à la signalisation d’une occlusion Le temps nécessaire à...

  • Page 71: Post-Occlusion Bolus

    Partie VIII – Caractéristiques techniques Post-occlusion bolus The occlusion alarm is activated when the SO CONNECT PID pump detects high pressure in the infusion line. The high pressure must be ♥ eliminated to prevent the accidental administration of a post-occlusion bolus to the patient, which may cause serious injury. The volume of the post-occlusion bolus of the SO CONNECT PID pump is: 0.5 ml ♥...
  • Page 72 Partie VIII – Caractéristiques techniques...
  • Page 73 Partie VIII – Caractéristiques techniques Advice and declaration of the manufacturer: electromagnetic immunity The SO CONNECT PID pump is designed for use in the electromagnetic environment specified below. The user of the SO CONNECT PID ♥ ♥ pump must make sure that it is used in such an environment. Immunity test IEC 60601 Test level Compliance level...
  • Page 74 Partie VIII – Caractéristiques techniques The user of the SO CONNECT PID pump can limit the electromagnetic interference by keeping a minimum distance between the ♥ CONNECT PID pump and mobile and portable RF communication equipment as recommended below, depending on the maximum power ♥...
  • Page 75 France Développement Electronique 46 Rue du Zornhoff 67700 MONSWILLER FRANCE SO-CONNECT PID user’s manual v2.01 (EN) 0459...

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