User’s manual (EN)
Parkinson
Ambulatory
Infusion pump
2
3
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
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
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
5
6
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
7
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.
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.
▪
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.
.
9
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.
10
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.
11
▪ 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
®
syringe, which makes
for very precise administration of the medication. The SO
♥
CONNECT PAR
®
pump administers a dose dependent on the set
infusion rate every 18 seconds.
▪ Bluetooth Low Energy connection
A Bluetooth Low Energy connection is used to export the clinical data and control the infusion with a remote control.
Remark
▪
France Développement Electronique shall only be liable for the safety and proper working of the
SO
♥
CONNECT PAR
®
pump
if it is used in accordance with these instructions and if any repairs or modifications have been carried out exclusively by France
Développement Electronique.
Contraindications
The SO
♥
CONNECT PAR
®
pump may not be used in case of severe cognitive impairment or psychotic symptoms and by persons who do not
have the physical capacity (paralysis, accident, malformation) or the necessary maturity (children) to use the SO
♥
CONNECT PAR
®
pump.
Adequate eyesight and hearing are necessary to identify the sound and visual alarms of the pump.
12
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
Reference in the manufacturer’s catalogue.
- pump body
- pump packaging
- syringe packaging
Serial number.
- pump body
- pump packaging
Date of manufacture.
- pump body
- pump packaging
Manufacturer.
- pump body
- pump packaging
- syringe packaging
Caution! Refer to the accompanying documentation for safety instructions.
- pump body
- battery compartment
Refer the instructions for use.
- pump body
- battery compartment
Disposal of Waste Electrical and Electronic Equipment (WEEE). This symbol shows
that waste batteries and electronic equipment may not be disposed of with
household waste, but collected separately.
- pump body
Type BF medical device (insulated from the patient, not protected from
defibrillation).
- pump body
0459
CE mark.
- pump body
- pump packaging
- syringe packaging
RoHS
Product compliant with Directive 2002/95/EC aimed at limiting hazardous
substances.
- pump body
IPX2
Protection rating.
- pump body
Electric Class: III
Equipment designed to be powered with voltage that does not exceed the limits of
extra low voltage and comprises no internal or external circuit operating at voltage
above those limits.
- pump body
Sterilisation process (ethylene oxide).
- syringe packaging
Not to be reused.
- syringe packaging
Not to be sterilised again.
- syringe packaging
LATE
X
Does not contain latex.
- syringe packaging
Manufacturing batch identification (year, month).
- syringe packaging
Expiry date (year, month).
- syringe packaging
Caution! Refer to the accompanying documentation for safety instructions.
- syringe packaging
13
Symbol
Description
Location
Refer the instructions for use.
- syringe packaging
Do not use if the packaging is damaged.
- syringe packaging
Store in a dry place, away from humidity.
- pump body
- pump packaging
- syringe packaging
Store away from sunlight.
- syringe packaging
Fragile.
- pump packaging
Storage temperature range.
- pump packaging
Storage humidity range.
- pump packaging
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. Actual performance data may differ from the stated data depending on
other external factors, particularly variations in counter-pressure, temperature, use of the infusion kit, viscosity of the solution or a
combination of these factors.
The SO
♥
CONNECT PAR
®
pump is classified as follows:
▪ class IIb medical device,
▪ type BF applied part,
▪ classified for continuous operation.
The SO
♥
CONNECT PAR
®
pump has a protection rating of IPX2:
▪ no protection against solid objects,
▪ protected from dripping water when tilted at 15° maximum.
14
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:
▪ SO
♥
CONNECT PAR
®
infusion pump,
▪ charged battery,
▪ SO
♥
FILL
®
syringe and sterile infusion line,
▪ injection pen or syringe that could replace the pump for administering apomorphine,
▪ vial of apomorphine,
▪ skin disinfectant,
▪ battery charger.
Warning
▪
Make sure you can use an alternative form of treatment if necessary. You should be informed of that alternative by the
healthcare professional in charge of treating you. Switch to the alternative treatment if you need to interrupt infusion using the
SO
♥
CONNECT PAR
®
pump.
15
Pump box
When you first open the box containing the SO
♥
CONNECT PAR
®
pump, please examine each component carefully for damage.
1. SO
♥
CONNECT pump (part: SO
♥
CONNECT)
2. 2 VARTA EZPack L batteries (part: SO
♥
BATTERY)
3. power cord for battery charger (part: SO
♥
POWER)
4. battery charger (part: SO
♥
CHARGER)
5. USB flash drive (part: SO
♥
KEY)
6. protective foam
7. simplified user's manual (Part: SO
♥
CONNECT PARKINSON Simplified user’s manual)
Remark
▪
These operating instruction is available in paper format upon request.
1
2
5
4
3
6
7
16
Optional accessories
T-shirt
o Black Lycra Size XS/S part: TSSMALLBLACK
o Black Lycra Size M/L part: TSMEDIUMBLACK
Bra pouch
o Black Lycra part: POUCHUNDERWEAR
Neoprene case for 20 ml SO
♥
FILL syringe
o Black part: N20BLACK
o Purple part: N20PURPLE
Neoprene case for 30 ml or 50 ml SO
♥
FILL syringe
o Black part: N50BLACK
o Purple part: N50PURPLE
o Red (boy) part: N50REDB
17
o Red (girl) part: N50REDG
Imitation leather case for 20 ml SO
♥
FILL syringe
o Anthracite grey part: L20WGREY
o Black part: L20WBLACK
Imitation leather case for 30 ml or 50 ml SO
♥
FILL syringe
o Anthracite grey part: L50WGREY
o Black part: L50WBLACK
SO
♥
PROTECT
o Black référence : SO-PROTECT
18
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
SO
♥
FILL
®
syringe.
Warning
▪
The materials used for the protective cases have not been tested for biocompatibility with the skin. Do not wear the protective
case against the body.
1) Insert the SO
♥
CONNECT PAR
®
pump into the protective case.
2) The SO
♥
CONNECT PAR
®
pump and SO
♥
FILL
®
syringe must be inserted all the way into
the protective case.
3) Close the protective case.
19
Pump component identification
The images below show the most important components of the SO
♥
CONNECT PAR
®
pump.
▪ ON/OFF button
The ON/OFF button is used to switch the screen on and off.
▪ Pump status indicator
The ON/OFF button incorporates an indicator light that immediately shows the pump operating status.
o Light off: the SO
♥
CONNECT PAR
®
pump is on standby or not powered.
o Blue light: the SO
♥
CONNECT PAR
®
pump is active.
▪ Touchscreen
The touchscreen of the SO
♥
CONNECT PAR
®
pump allows you to set up and control the infusion. Also, the screen displays
important information about the status of the pump. If the screen is not pressed, it goes off automatically after 1 minute to save
battery power.
Remark
▪
When you are not using the screen, you can press on the ON/OFF button to turn it off without waiting for it to turn off
automatically and thus save battery power.
Pusher
Identification label
Touchscreen
Cover of
battery
compartment
ON/OFF button
20
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 problem persists, please contact user support.
Battery
The SO
♥
CONNECT PAR
®
can only operate when it is powered by a VARTA EZPack L rechargeable
battery supplied with the pump, sourced from France Développement Electronique only. The
SO
♥
CONNECT PAR
®
pump is supplied with two batteries. As a result, you can always have a charged
spare battery that is ready for use.
The battery specifications are as follows:
Part
VARTA EZPACK L
Rated voltage
3.7 V
Capacity
1200 mAh typical
Watt hours
4.5 Wh
Number of cycles
> 500 cycles
Precautions
▪
Do not use any other batteries than the one supplied by France Développement Electronique. Using another type of battery
may damage the
SO
♥
CONNECT PAR
®
pump.
▪
When a battery is not in use, store it in a clean dry place away from sunlight.
▪
The batteries are delivered uncharged. You must therefore charge them completely before using them.
Date
Time
Battery level
Cancel and return
to previous screen
Confirm and go to
next screen
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