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Parkinson So Connect PAR User Manual

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

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Summary of Contents for Parkinson So Connect PAR

  • Page 1 Ambulatory Infusion pump User’s manual (EN) Parkinson...

  • Page 3: Table Of Contents

    Table of contents About this manual..................................................6 Safety rules ....................................................7 Part I – Description of pump and accessories ........................................9 Description of the pump ..............................................10 Contraindications ................................................. 11 Symbols and labelling ................................................12 Compliance and classification ............................................13 Emergency kit..................................................
  • Page 4 Modifying boluses configuration............................................56 Priming during the infusion...............................................57 Bolus dose injection ................................................58 Stopping the infusion ................................................59 Infusion about to end ................................................60 End of infusion ..................................................60 Part VI – Alarms ..................................................61 Alarm system ...................................................62 Device failure alarm (high priority) ..........................................63 Syringe missing alarm (high priority) ..........................................63 Infusion about to end alarm (low priority) .........................................63 End of infusion alarm (high priority) ..........................................64 Occlusion alarm (high priority) ............................................64...

  • Page 6: 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 PAR ® ambulatory infusion pump. Regardless of your experience of ambulatory infusion pumps, please ♥...

  • Page 7: Safety Rules

    Safety rules ♥ This chapter contains important safety instructions that must be read before using the SO CONNECT PAR ® pump. ♥ For safety information regarding the individual functions of the SO CONNECT PAR ® pump, refer to the corresponding section of the Instructions for Use.
  • Page 8 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 9: 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 10: Description Of The Pump

    ® pump is an ambulatory infusion pump that is intended for the controlled subcutaneous administration of ♥ apomorphine (active ingredient) for treating Parkinson’s disease. It uses 20 ml, 30 ml or 50 ml SO FILL ® sterile single-use syringes. Those ♥...

  • Page 11: Contraindications

    Locking of setup function ▪ The infusion setup functions are only accessible after entering a password. Infusion precision ▪ ♥ ♥ The feed mechanism (pusher) of the SO CONNECT PAR ® pump directly controls the seal of the SO FILL ®...

  • Page 12: Symbols And Labelling

    Symbols and labelling ♥ The table below provides the meaning of the symbols present on the labels of the SO CONNECT PAR ® pump and its accessories. Symbol Description Location - pump body Reference in the manufacturer’s catalogue. - pump packaging - syringe packaging - pump body Serial number.

  • Page 13: Compliance And Classification

    Symbol Description Location Refer the instructions for use. - syringe packaging Do not use if the packaging is damaged. - syringe packaging - pump body Store in a dry place, away from humidity. - pump packaging - syringe packaging Store away from sunlight. - syringe packaging Fragile.

  • Page 14: Emergency Kit

    Emergency kit Users are strongly advised to keep spare accessories and consumable supplies for emergencies. In that way, you will be able to quickly make any replacement needed. An emergency kit must contain the following: ♥ CONNECT PAR ® infusion pump, ▪...

  • Page 15: Pump Box

    (part: SO POWER) ♥ battery charger (part: SO CHARGER) USB flash drive (part: SO ♥ KEY) protective foam ♥ simplified user's manual (Part: SO CONNECT PARKINSON Simplified user’s manual) Remark These operating instruction is available in paper format upon request. ▪...

  • Page 16: Optional 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 Black part: N20BLACK Purple part: N20PURPLE ♥ ...
  • Page 17 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 Anthracite grey part: L50WGREY Black part: L50WBLACK ...

  • Page 18: Using The Case

    Using the case ♥ The protective case protects the SO CONNECT PAR ® pump from splashing liquids and impacts when it is in use. It also protects the ♥ FILL ® syringe. Warning The materials used for the protective cases have not been tested for biocompatibility with the skin. Do not wear the protective ▪...

  • Page 19: Pump Component Identification

    Pump component identification ♥ The images below show the most important components of the SO CONNECT PAR ® 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 20: Battery

    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 ▪...

  • Page 21: Battery Charger

    Battery charger ♥ The battery charger supplied with the SO CONNECT PAR ® pump can recharge the VARTA EZPack L batteries. The battery charger specifications are as follows: Model number MASCOT Type 3745 Rated AC voltage 90 – 264 VAC 47/63 Hertz Charge voltage 4.2 VDC Charge intensity...

  • Page 22: 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 23: Battery Charging

    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 24: Inserting The Battery

    Inserting the battery ♥ Before using the SO CONNECT PAR ® 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 25: 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 26: Password Entry

    Password entry Access to the functions reserved for medical personnel is only possible after they enter a password. ♥ The SO CONNECT PAR ® pump displays the numeric keypad for entering the password. Press “ ” to return to the previous screen. ▪...
  • Page 27 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 28 Warning It is crucial to set the correct time. That information is required for managing infusion rates and clinical data. Setting the time ▪ incorrectly can result in the incorrect administration of apomorphine. If the time zone is changed or if there is a time change, make sure the time setting is changed accordingly. ▪...
  • Page 29 Warning Setting the correct date is crucial. Clinical data management is dependent on this setting. If the time zone is changed, make sure ▪ the date setting is changed accordingly. Language setting ♥ When the SO CONNECT PAR ® pump displays the language setting tab. Press the language to modify it.

  • Page 30: Setting Up An Infusion

    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 ♥...
  • Page 31 ♥ After the password is confirmed, the SO CONNECT PAR ® pump displays patient information screen. Press “ ” to return to the main screen. ▪ Press “ ” to go to the next screen. ▪ By default, the surname, first name, and name of the medication are empty. The date of birth is 00/00/0000.
  • Page 32 Entering the date of birth ♥ When the SO CONNECT PAR ® pump displays the patient information screen, press the date of birth to modify it. ♥ ® The SO CONNECT PAR pump will display a numeric keypad for entering the patient’s date of birth.
  • Page 33 ♥ When you press the type of syringe, the SO CONNECT PAR ® pump displays the list of compatible ♥ FILL ® syringes. ♥ Press the type of SO FILL ® syringe used for the infusion. ▪ Press “ ” to cancel and return to the previous screen. ▪...
  • Page 34 ♥ When you press concentration, the SO CONNECT PAR ® pump displays the numeric keypad for setting the concentration of the medication. The concentration value may range from 0.00 mg/ml to 9.99 mg/ml. Use the keypad to enter the concentration value. ▪...
  • Page 35 ♥ When you press a start or end time of a time slot, the SO CONNECT PAR ® pump displays the numeric keypad for setting that parameter. Use the keypad for setting the time. ▪ Press “ ” to cancel and return to the previous screen. ▪...
  • Page 36 Step 6: programming the bolus doses Three parameters need to be set for bolus doses: number of bolus doses allowed during the infusion, ▪ bolus volume, ▪ lockout interval, that is to say the minimum period between two bolus doses. ▪...

  • Page 37: Pump Initialization

    ♥ The SO CONNECT PAR ® pump displays the status of medication alarms (enabled, disabled) and the number of alarms set. Press the parameter you wish to modify. ▪ Press “ ” to return to the previous screen. ▪ Press “ ” to go to the next screen. ▪...
  • Page 38 The pump will display the first setup tab (Time, Date and Date format). Press “Initialization” to initialize patient information and infusion parameters. ▪ Press “<” to return the main screen. ▪ After pressing Initialization, the pump displays a confirmation request. Press “✓”...

  • Page 39: Part Iv - So ♥ Fill ® Syringe And Infusion Set

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

  • Page 40: So ♥ Fill ® Syringe

    ♥ FILL ® 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 41 ♥ Filling the SO FILL 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. ♥...
  • Page 43 ♥ 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 44: Infusion Set

    ♥ Connecting the SO FILL 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 45 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. Infusion sites The images below show the recommended infusion sites.

  • Page 46: Part V - Infusion

    Part V – infusion This part of the user’s manual contains the following information: starting an infusion ▪ infusion control screen, ▪ pausing the infusion, ▪ restarting the infusion, ▪ viewing infusion rates in AUTO mode, ▪ viewing and selection the infusion rate in MANUAL mode, ▪...

  • Page 47: Starting An Infusion

    Starting 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. The infusion start is carried out from the main screen.
  • Page 48 Step 4a: infusion rates checking (AUTO mode) ♥ ® After confirming the volume and the concentration, the SO CONNECT PAR pump displays the infusion rates. Press “ ” to return to the previous screen. ▪ Press “ ” to go to the next screen. ▪...
  • Page 49 ♥ Step7: installing the SO FILL syringe ® ♥ After filling the SO FILL ® syringe, you can put it in place. To do so, follow the instructions described ♥ in the section Connecting the SO FILL ® syringe. Press “ ” to return to the boluses configuration screen after pusher retracting. ▪...

  • Page 50: Infusion Control Screen

    Step 9: starting the infusion Press the Start button to start the infusion. Infusion control screen ♥ During the infusion, the SO CONNECT PAR ® pump displays information about its status. Current infusion rate Remaining volume Bolus order Remaining time Number of boluses Number of boluses allowed Infusion control menu...

  • Page 51: Pausing The Infusion

    Pausing the infusion While the infusion is under way, you can pause it. Press “ ” for two seconds. ▪ ♥ The SO CONNECT PAR ® pump will display the infusion management menu. Press “Pause” for two seconds. ▪ ♥ The SO CONNECT PAR ®...

  • Page 52: Viewing Infusion Rates In Auto Mode

    ♥ The SO CONNECT PAR ® pump will resume the infusion. Viewing infusion rates in AUTO mode To view the infusion rates set when the infusion is in AUTO mode, press the displayed infusion rate for two seconds. ♥ The SO CONNECT PAR ®...

  • Page 53: Modifying The Infusion Rates

    Modifying the infusion rates ♥ The SO CONNECT PAR ® pump makes it possible to adjust the infusion rate during infusion. This function is of great use when the pump infusion rate is being adapted to the patient’s motor condition. If the infusion is under way, press “...
  • Page 54 ♥ When you press a start or end time of a time slot, the SO CONNECT PAR ® pump displays the numeric keypad for setting that parameter. Use the keypad for setting the time. ▪ Press “ ” to cancel and return to the previous screen. ▪...

  • Page 55: Viewing Boluses Configuration

    Viewing boluses configuration ♥ The SO CONNECT PAR ® pump makes it possible to view the boluses configuration during infusion. If the infusion is under way, press “ ” for two seconds. If the infusion is paused, press “ ” for two seconds. ♥...

  • Page 56: Modifying Boluses Configuration

    Modifying boluses configuration ♥ The SO CONNECT PAR ® pump makes it possible to adjust the infusion rate during infusion. If the infusion is under way, press “ ” for two seconds. If the infusion is paused, press the “ ” button for two seconds. ♥...

  • Page 57: Priming During The Infusion

    ♥ When you press the number of bolus doses, the SO CONNECT PAR ® pump displays the numeric keypad for setting that parameter. The number of bolus doses allowed during the infusion ranges from 00 to 99. Use the keypad to enter the number of bolus allowed. ▪...

  • Page 58: Bolus Dose Injection

    If the infusion is paused, press “ ” for two seconds. Press “Perform priming” for two seconds. ♥ After connecting the infusion line to the SO FILL ® syringe, hold your finger on “Priming” to prime the whole infusion line. Press “...

  • Page 59: Stopping The Infusion

    While injecting a bolus, the circle is displayed in white. Stopping the infusion If the infusion is under way, press “ ” for two seconds. If the infusion is paused, press “ ” for two seconds. ♥ The SO CONNECT PAR ®...

  • Page 60: Infusion About To End

    Infusion about to end ♥ The SO CONNECT PAR ® pump generates an alarm approximately 5 minutes before the end of the infusion. The infusion is not stopped when this alarm is generated. For more information about this alarm, refer to Part III –...

  • Page 61: Part Vi - Alarms

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

  • Page 62: Alarm System

    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 PAR ®...

  • Page 63: Device Failure Alarm (High Priority)

    Device failure alarm (high priority) ♥ The SO CONNECT PAR ® pump regularly checks if it is operating correctly. If a fault is found in any ♥ of its components, the SO CONNECT PAR ® pump generates a device failure alarm. When this alarm occurs, the infusion is paused automatically.

  • Page 64: End Of Infusion Alarm (High Priority)

    End of infusion alarm (high priority) ♥ At the end of the infusion, the SO CONNECT PAR ® pump generates an alarm. Occlusion alarm (high priority) ♥ The SO CONNECT PAR ® pump generates an occlusion alarm when it detects excess pressure in the infusion line.

  • Page 65: Medication Reminder Alarm (Low Priority)

    Medication reminder alarm (low priority) ♥ The SO CONNECT PAR ® pump has a function for reminding the patient to take his or her ♥ medication. At each set time, the SO CONNECT PAR ® pump generates an alarm. The infusion is not stopped when this alarm is generated. Infusion in pause (low priority) ♥...

  • Page 66: 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 67: Cleaning And Disinfection Of The Pump

    Cleaning and disinfection of the pump ♥ ♥ Take the opportunity of a replacement of the SO FILL ® syringe, for example, to clean the SO CONNECT PAR ® pump. To do so, use a soft dry cloth to clean the outside of the pump. ♥...

  • Page 68: Maintenance

    ♥ Inspect the SO FILL ® syringe carefully. Check that the actual quantity of fluid to inject in the syringe is indeed the quantity ▪ displayed on the screen. Inspect every component of the pump and the infusion device at regular intervals during the day and before you go to bed. If you ▪...
  • Page 69 Warning Inspect the pump immediately in the event of a fall or impact. ▪ Do not use the ♥ pump if you see any cracks or other signs of damage. Water, dust, infusion fluid or other CONNECT PAR ® ▪ foreign material could enter into the pump and lead to malfunctioning.

  • Page 70: Pump Coming In Contact With Water

    Pump coming in contact with water Precautions ♥ CONNECT PAR ® pump is not sealed. Use the case supplied with your pump to protect it from accidental splashing with ▪ 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 71: Storing The Pump

    Storing the pump ♥ If you do not intend to use the SO CONNECT PAR ® pump for a long period of time, store it in an appropriate manner so as to avoid any subsequent malfunctioning. To store the pump: remove the battery to conserve it, ▪...

  • Page 72: Guarantee Conditions

    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 73: 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 74: Declaration Of Conformity

    Declaration of conformity...

  • Page 75: Pump Specifications

    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 10 infusions Battery lifespan > 500 cycles (>70% of initial capacity) Disposable syringe ♥...

  • Page 76: Pump Precision

    700 hPA / 1060 hPA Pump storage condition 0°C / 50°C 5% / 90% relative humidity without condensation 700 hPa/1060 hPA Acoustic range of sound alarm 44 dB(A) for high-priority alarms 38 dB(A) for low-priority alarms Maximum volume infused in first fault condition 0.5% of the infusion rate/hour Pump precision The graphs and curves below have been calculated from the pump precision verification procedures described in standard IEC 60601-2-24.
  • Page 77 Starting infusion rate Programmed infusion rate: 2 ml/h Débit au démarrage Durée (min) Débit réel Débit programmé 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...

  • Page 78: Pressure Level

    Pressure level The occlusion pressure level is 1.5 bar. Time required for reporting an occlusion The time required for reporting an occlusion is the time interval between the start of the occlusion and the detection of that condition by ♥ the SO CONNECT PAR ®...

  • Page 79: Electromagnetic Compatibility

    Electromagnetic compatibility ♥ The information contained in this section is provided as recommendations for the proper operating of the SO CONNECT PAR ® pump in respect of electromagnetic compatibility. The tables presented in this section refer to the criteria of the standard IEC 60601-1-2. Warning Mobile and RF communication devices are likely to affect the working of devices such as the ♥...
  • Page 80 Advice and declaration of the manufacturer: electromagnetic immunity ♥ ♥ The SO CONNECT PAR ® pump is designed for use in the electromagnetic environment specified below. The user of the SO CONNECT ® pump must make sure that it is used in such an environment. Immunity test IEC 60601 Test level Compliance level...
  • Page 81 ♥ The user of the SO CONNECT PAR ® pump can limit the electromagnetic interference by keeping a minimum distance between the ♥ CONNECT PAR ® pump and mobile and portable RF communication equipment as recommended below, depending on the maximum power of the emitting equipment.
  • Page 82 France Développement Electronique 46 Rue du Zornhoff 67700 MONSWILLER FRANCE ♥ CONNECT PAR user’s manual v2.01 (EN) 0459...

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