FDE SO-CONNECT PID User Manual
User’s manual (EN)
Ambulatory infusion pump
2
3
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 ................................................................................................................................................................................................................................................... 14
Using the case ................................................................................................................................................................................................................................................................ 16
Pump component identification ............................................................................................................................................................................................................................ 17
Battery ............................................................................................................................................................................................................................................................................... 18
Battery charger ............................................................................................................................................................................................................................................................. 19
Part II – Starting the pump ............................................................................................................................................................................................................................................ 20
Battery charging ........................................................................................................................................................................................................................................................... 21
Inserting the battery ................................................................................................................................................................................................................................................... 22
Part III – Pump programming ....................................................................................................................................................................................................................................... 23
Password entry.............................................................................................................................................................................................................................................................. 24
Setting up the pump .................................................................................................................................................................................................................................................... 24
Setting up an infusion ................................................................................................................................................................................................................................................. 28
Pump initialization ........................................................................................................................................................................................................................................................ 35
Part IV – Syringe and infusion set .............................................................................................................................................................................................................................. 36
Syringe ............................................................................................................................................................................................................................................................................... 37
Infusion set ...................................................................................................................................................................................................................................................................... 40
Partie V – Infusion ............................................................................................................................................................................................................................................................. 42
Starting an infusion ...................................................................................................................................................................................................................................................... 43
Infusion control screen .............................................................................................................................................................................................................................................. 45
Infusion control menu ................................................................................................................................................................................................................................................ 45
Pausing the infusion .................................................................................................................................................................................................................................................... 46
Restarting the infusion ............................................................................................................................................................................................................................................... 47
Modifying the infusion rates – Function reserved to medical staff ....................................................................................................................................................... 48
End of infusion ............................................................................................................................................................................................................................................................... 50
Unwanted effects ......................................................................................................................................................................................................................................................... 51
Exporting clinical data –
Function reserved for medical staff
.................................................................................................................................................................. 52
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Visualization of the internal information of the pump –
Function reserved for medical staff
.................................................................................................. 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) ........................................................................................................................................................................................................ 56
End of infusion alarm (high priority) .................................................................................................................................................................................................................... 57
Occlusion alarm (high priority) ............................................................................................................................................................................................................................... 57
Battery low alarm (low priority) ............................................................................................................................................................................................................................. 57
Infusion in pause (low priority) ............................................................................................................................................................................................................................... 58
Part VII – general recommendations, maintenance, disposal, terms of guarantee and declaration of conformity ............................................................. 59
Cleaning and disinfection of the pump ............................................................................................................................................................................................................... 60
Pump inspection ............................................................................................................................................................................................................................................................ 61
Maintenance ................................................................................................................................................................................................................................................................... 61
Alarm system testing .................................................................................................................................................................................................................................................. 61
Pump damage in the event of a fall or impact .................................................................................................................................................................................................. 62
Pump coming in contact with water ..................................................................................................................................................................................................................... 63
Storing the pump .......................................................................................................................................................................................................................................................... 64
Disposal............................................................................................................................................................................................................................................................................. 64
Pump life ........................................................................................................................................................................................................................................................................... 64
Guarantee conditions ................................................................................................................................................................................................................................................. 65
Part VII – Technical specifications ............................................................................................................................................................................................................................. 66
Declaration of conformity ........................................................................................................................................................................................................................................ 67
Pump specifications ..................................................................................................................................................................................................................................................... 68
Pump precision .............................................................................................................................................................................................................................................................. 69
Niveau de pression ...................................................................................................................................................................................................................................................... 70
Temps nécessaire à la signalisation d’une occlusion .................................................................................................................................................................................... 70
Post-occlusion bolus ................................................................................................................................................................................................................................................... 71
Electromagnetic compatibility ............................................................................................................................................................................................................................... 71
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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 PID 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 PID 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 cl ear, please contact user
support.
For the safe and correct use of the SO♥CONNECT PID pump, please pay 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 PID
pump or compromise the quality of the
treatment.
Comments
▪
Remarks contain additional information for optimum and efficient operation of your
SO♥CONNECT PID
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
6
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
Instructions for Use.
Warning
▪
This user’s manual for the
SO♥CONNECT PID
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 PID
pump.
▪
Before using the
SO♥CONNECT PID
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 PID
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 PID
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 PID
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 PID
pump to therapeutic ion radiation. During
radiotherapy the pump should be switched off.
▪
Never use the
SO♥CONNECT PID
pump near a Magnetic Resonance Imaging (MRI) device as the magnetic fields may interfere
with the operation of the pump.
▪
The
SO♥CONNECT PID
pump is not suitable for use in the presence of flammable anaesthetics mixtures with air, oxygen or nitrous
oxide. Use of the
SO♥CONNECT PID
pump in the presence of such mixtures may cause an explosion or fire.
▪
The
SO♥CONNECT PID
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.
Partie I – Description of pump and accessories
9
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
reservoirs.
▪ DESFERAL in the treatment of primary haemochromatosis not curable by bleeding, hemosiderosis.
Those SO♥FILL reservoirs have been designed especially for use with the SO♥CONNECT PID pump.
The SO♥CONNECT PID 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 PID pump have been designed to make treatment easier and keep the patient safe.
▪ Screen with resistive touch panel
The SO♥CONNECT PID pump has a screen with a resistive touch panel that makes configuration and infusion control easier.
▪ Programming the infusion rate or duration of the infusion
The infusion rate can be set from 0 to 60 ml/h in increments of 0.1 ml.
▪ Facility to adjust the infusion rate during infusion
The SO♥CONNECT PID pump makes it possible to adjust the infusion rate during infusion.
▪ 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 rapidly.
▪ Locking of setup and configuration functions
The SO♥CONNECT PID pump setup and the settings of an infusion are only accessible after entering a password.
▪ Infusion precision
The feed mechanism (pusher) of the SO♥CONNECT PID pump directly controls the plunger of the SO♥FILL reservoir, which makes
for very precise administration of the medication. The SO♥CONNECT PID 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.
Partie I – Description of pump and accessories
10
Remark
▪
France Développement Electronique shall only be liable for the safety and proper working of the
SO♥CONNECT PID
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 PID 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 PID pump.
Adequate eyesight and hearing are necessary to identify the sound and visual alarms of the pump.
Symbols and labelling
The table below provides the meaning of the symbols present on the labels of the SO♥CONNECT PID 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
Partie I – Description of pump and accessories
11
Symbol
Description
Location
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
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
Partie I – Description of pump and accessories
12
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 PID pump is classified as follows:
▪ class IIb medical device,
▪ type BF applied part,
▪ classified for continuous operation.
The SO♥CONNECT PID pump has a protection rating of IPX2:
▪ no protection against solid objects,
▪ protected from dripping water when tilted at 15° maximum.
Partie I – Description of pump and accessories
13
Pump box
When you first open the box containing the SO♥CONNECT PID pump, please examine each component carefully for damage.
1. SO♥CONNECT PID pump (part: SO♥CONNECT PID)
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 PID Simplified user’s manual)
Remark
▪
These operating instruction is available in paper format upon request.
1 2 5 4 3 6 7
Partie I – Description of pump and accessories
14
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
Partie I – Description of pump and accessories
15
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
o Black référence : SO-PROTECT
Partie I – Description of pump and accessories
16
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. Do not wear the protective case
against the body.
1) Insert the SO
♥
CONNECT PID pump into the protective case.
2) The SO
♥
CONNECT PID pump and SO♥FILL syringe must be inserted all the way into the
protective case.
3) Close the protective case.
Partie I – Description of pump and accessories
17
Pump component identification
The images below show the most important components of the SO♥CONNECT PID 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 PID pump is on standby or not powered.
o Blue light: the SO
♥
CONNECT PID pump is active.
▪ Touchscreen
The touchscreen of the SO♥CONNECT PID 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
Partie I – Description of pump and accessories
18
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 PID 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 PID 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 PID
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
Partie I – Description of pump and accessories
19
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 – 264 VAC 47/63 Hertz
Charge voltage
4.2 VDC
Charge intensity
1.5 A
Dimensions
115 x 56 x 35 mm
Weight
175 g
Conditions of use
-25°C à +40°C
Storage conditions
-25°C à +85°C
Electrical safety
EN/IEC/ANSI 60601-1 3ed
EN/IEC 60335-1 et 2-29
EN/IEC/UL 62368-1
Electromagnetic compatibility
EN 61000-6-1 et -3
EN 60601-1-2
EN 55014-1 et -2
EN 55022 et EN 55024
EN 55032
Warning
▪
Do not attempt to recharge cells or batteries other than those supplied by France Développement Electronique.
▪
Disconnect the charger from the power socket when you no longer intend to use it. To disconnect the power cord, hold it by the
plug inserted in the socket. Do not pull it directly.
▪
Do not use the charger if the cord is damaged or if the charger has been dropped or is damaged.
▪
Do not twist the power cord excessively and do not place any heavy objects on it. That could damage it and lead to a fire or electric
shock.
▪
Do not dismantle the charger.
▪
Protect the charger from impacts and falls.
20
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.
Partie II – Starting the pump
21
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.
▪ If a problem occurs during charging, disconnect the charger from the wall socket immediately in order to stop the power supply.
▪ Do not place the charger in areas that are very hot or cold, dusty or dirty, humid or subject to heavy vibrations.
Precautions
▪
Make sure you always use the battery charger supplied with the
SO♥CONNECT PID
pump only. Using another type of charger
may damage the battery.
Comments
▪
The charger will heat up slightly while in use. This is not a sign of malfunctioning.
The light on the charger shows the battery charge status.
Flashing yellow or steady yellow: charging in progress.
Steady green light: battery fully charged
Flashing green light: battery not connected
Flashing red light: error
Partie II – Starting the pump
22
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
SO♥CONNECT PID
pump.
▪
In order to keep water out of the
SO♥CONNECT PID
pump housing, install or replace the battery in a dry place.
▪
Make sure that the battery compartment cover is not damaged or missing and that the battery has been installed correctly.
▪
Take care to insert the battery in the right direction. Inserting the battery in the wrong direction could damage the
SO♥CONNECT
PID
pump.
1) Slide the battery compartment cover from right to left until it comes completely out of the
groove.
2) Insert the battery in the compartment of the SO
♥
CONNECT PID pump. Take care to insert
the battery the right way: the + end of the battery must be at the + terminal of the pump, and
likewise for the – end.
The battery's label should be facing downwards, towards the bottom of the battery
compartment.
3) Insert the battery compartment cover back in the groove. And slide the cover back into place,
from left to right.
23
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.
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