Parkinson So Connect PAR User manual

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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Parkinson So Connect PAR User manual

Parkinson So Connect PAR User manual

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