Parkinson So Connect PAR User manual

User’s manual (EN)
Parkinson
Ambulatory
Infusion pump

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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......................................................................................................................................................................................................................................................... 14
Pump box.................................................................................................................................................................................................................................................................. 15
Optional accessories........................................................................................................................................................................................................................................... 16
Using the case ........................................................................................................................................................................................................................................................ 18
Pump component identification .................................................................................................................................................................................................................... 19
Battery....................................................................................................................................................................................................................................................................... 20
Battery charger ..................................................................................................................................................................................................................................................... 21
Part II –Starting the pump .....................................................................................................................................................................................................................................22
Battery charging ................................................................................................................................................................................................................................................... 23
Inserting the battery ........................................................................................................................................................................................................................................... 24
Part III –Pump programming................................................................................................................................................................................................................................25
Password entry...................................................................................................................................................................................................................................................... 26
Setting up the pump ............................................................................................................................................................................................................................................ 26
Setting up an infusion ......................................................................................................................................................................................................................................... 30
Pump initialization................................................................................................................................................................................................................................................ 37
Part IV –SO♥FILL®syringe and infusion set..................................................................................................................................................................................................39
SO♥FILL®syringe ................................................................................................................................................................................................................................................. 40
Infusion set.............................................................................................................................................................................................................................................................. 44
Part V –infusion..........................................................................................................................................................................................................................................................46
Starting an infusion.............................................................................................................................................................................................................................................. 47
Infusion control screen...................................................................................................................................................................................................................................... 50
Pausing the infusion ............................................................................................................................................................................................................................................ 51
Restarting the infusion....................................................................................................................................................................................................................................... 51
Viewing infusion rates in AUTO mode ....................................................................................................................................................................................................... 52
Viewing and selecting the infusion rate in MANUAL mode.............................................................................................................................................................. 52
Modifying the infusion rates ........................................................................................................................................................................................................................... 53
Viewing boluses configuration ....................................................................................................................................................................................................................... 55

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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
Battery low alarm (low priority)......................................................................................................................................................................................................................64
Medication reminder alarm (low priority)..................................................................................................................................................................................................65
Infusion in pause (low priority)........................................................................................................................................................................................................................65
Part VII –general recommendations, maintenance, disposal, terms of guarantee and declaration of conformity ......................................................66
Cleaning and disinfection of the pump........................................................................................................................................................................................................67
Pump inspection.....................................................................................................................................................................................................................................................67
Maintenance............................................................................................................................................................................................................................................................68
Alarm system testing ...........................................................................................................................................................................................................................................68
Pump damage in the event of a fall or impact...........................................................................................................................................................................................68
Pump coming in contact with water..............................................................................................................................................................................................................70
Storing the pump ...................................................................................................................................................................................................................................................71
Disposal......................................................................................................................................................................................................................................................................71
Pump life....................................................................................................................................................................................................................................................................71
Guarantee conditions..........................................................................................................................................................................................................................................72
Part VII –Technical specifications......................................................................................................................................................................................................................73
Declaration of conformity .................................................................................................................................................................................................................................74
Pump specifications..............................................................................................................................................................................................................................................75
Pump precision.......................................................................................................................................................................................................................................................76
Pressure level..........................................................................................................................................................................................................................................................78
Time required for reporting an occlusion ..................................................................................................................................................................................................78
Post-occlusion bolus ............................................................................................................................................................................................................................................78
Electromagnetic compatibility ........................................................................................................................................................................................................................79

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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
read the whole manual carefully before you begin to use the SO♥CONNECT PAR®pump.
This user’s manual should be kept available for future use. If in doubt or if any of the information in this manual is not clear, please contact
user support.
For the safe and correct use of the SO♥CONNECT PAR®pump, please pay particular attention to the following points in this user’s manual:
Warning
▪ A warning message contains safety information which, if ignored, may cause serious injury.
Precautions
▪ Precautions indicate instructions which, if ignored, may damage the SO♥CONNECT PAR® pump or compromise the quality of
the treatment.
Comments
▪ Remarks contain additional information for optimum and efficient operation of your SO♥CONNECT PAR® pump .
This user’s manual is made up of several parts:
▪Part I (blue):description of pump and accessories.
▪Part II (green): starting the pump
▪Part III (brown): pump programming
▪Part IV (yellow): SO♥FILL®syringe
▪Part V (orange): infusion
▪Part VI (red): alarms
▪Part VII (purple): general recommendations, maintenance, disposal, terms of guarantee and declaration of conformity
▪Part VIII (grey): technical specifications

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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.
Warning
▪ This user’s manual for the SO♥CONNECT PAR® ambulatory infusion pump is provided subject to the conditions and
restrictions stated therein.
▪ The infusion pump should only be used by persons who have been instructed in the operation of the SO♥CONNECT PAR®
pump.
▪ Before using the SO♥CONNECT PAR® pump, read the operating instructions and familiarize yourself with the device.
▪ Changing the basic settings, programming the pump and exporting the therapy information can only be done after entering the
password.
▪ Handle the password confidentially and pass it on only to trained persons.
▪ The SO♥CONNECT PAR®
pump is designed for use under the responsibility or supervision of a physician and/or an approved
healthcare professional trained in the use of the pump and the administration of medicines. The instructions for use provided
in this manual may not in any event replace the medical care protocol in place for the patient.
▪ Incorrect programming may cause injury to the patient.
▪ The medical personnel, home care giver or clinician shall train those who use the SO♥CONNECT PAR® pump at home.
▪ The date and time must be entered correctly, as the therapy information is directly related to the time of the SO♥CONNECT
PAR®
pump. Care must also be taken to ensure the correct time when the flow rate programming or time zone has been
changed.
▪ Do not vent the catheter while it is connected to the patient, as this may result in overdose of the drug.
▪ Before starting an infusion, check the catheter to avoid possible kinks, closed braces or other occlusions.
▪ To avoid damaging the infusion pump and its accessories, never leave the units unattended within reach of children and pets.
▪ To avoid damaging the pump, do not sterilize components of the infusion pump.
▪ If the infusion pump should fall or be shocked, make sure the pump is not damaged. Never use the infusion pump if it shows
cracks or other visible damage.

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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.
▪ Dispose of the packaging, infusion set, battery and all other electronic components properly to protect the environment.
▪ The infusion pump complies with the IEC 60601-1-2 Electromagnetic Compatibility standard and can therefore be used with
other medical devices that comply with this standard. However, to avoid pump malfunction, do not use the pump near strong
sources of electromagnetic interference.
▪ To avoid irreversible damage to the circuits, do not expose the SO♥CONNECT PAR® pump to therapeutic ion radiation. During
radiotherapy the pump should be switched off.
▪ Never use the SO♥CONNECT PAR®
pump near a Magnetic Resonance Imaging (MRI) device as the magnetic fields may
interfere with the operation of the pump.
▪ The SO♥CONNECT PAR®
pump is not suitable for use in the presence of flammable anaesthetics mixtures with air, oxygen or
nitrous oxide. Use of the SO♥CONNECT PAR®
pump in the presence of such mixtures may cause an explosion or fire.
▪ The SO♥CONNECT PAR®
pump can only be repaired by a qualified and trained technician.
▪ Unauthorized modifications may impair pump operation and result in injury or death to the patient or user.
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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,
▪ pump component identification,
▪ battery,
▪ battery charger.

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Description of the pump
The SO♥CONNECT PAR®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
SO♥FILL®syringes have been designed especially for use with the SO♥CONNECT PAR®pump.
The SO♥CONNECT PAR®pump has been designed for use by healthcare professionals in a clinical environment and by ambulatory users
(patients and healthcare professionals) in patients’ homes.
The features of the SO♥CONNECT PAR®pump have been designed to make treatment easier and keep the patient safe.
▪Screen with resistive touch panel
The SO♥CONNECT PAR®pump has a screen with a resistive touch panel that makes configuration and infusion control easier.
▪Two operating modes for infusion: MANUAL or AUTO
In MANUAL mode, the SO♥CONNECT PAR®pump offers the possibility to set up to 3 infusion rates that can be selected according
to the needs during the infusion.
In AUTO mode, the SO♥CONNECT PAR®pump offers the possibility to set up to 4 time slots over a period of 24 hours. Each of
these time slots is associated with an adjustable infusion rate.
▪Setting up infusion rates
Infusion rates can be set in ml/h or mg/h.
Infusion rates can be adjusted from 0 to 8 ml/h in increments of 0.01 ml/h or from 0 to 15 mg/h in increments of 0.01 mg/h.
▪Bolus setup
The SO♥CONNECT PAR®pump allows you to define the number of bolus doses allowed during the infusion, the volume of a bolus
(from 0 to 8 ml in increments of 0.01 ml or from 0 to 15 mg/h in increments of 0.01 mg/h) and duration of the lockout interval (from
0 to 24 h in increments of 15 minutes).
▪Medication reminder alarm (optional)
The SO♥CONNECT PAR®pump features alarms to remind the patient to take his or her oral medication. It offers the facility to set
up to 24 different times for these alarms.
▪Facility to adjust the infusion rate during infusion
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.
▪Saving of infusion settings
The settings of the last infusion are saved automatically even if the battery is changed. They can be used to start an infusion more
speedily.
▪Priming
The SO♥CONNECT PAR®pump has a priming function, which is available when the infusion starts or during the infusion process.