FDE SO-CONNECT PID Bedienungsanleitung

User’s manual (EN)

Ambulatory infusion pump

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 

4 
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 
 
 

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 clear, 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

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.

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.

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

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

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

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