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FDE SO-CONNECT PID, Руководство пользователя

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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. 

 

 

 

Содержание SO-CONNECT PID

Страница 1: ...User s manual EN Ambulatory infusion pump...

Страница 2: ...2...

Страница 3: ...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...

Страница 4: ...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...

Страница 5: ...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 instruction...

Страница 6: ...hcare professional trained in theuseofthepumpand theadministration ofmedicines Theinstructionsfor useprovided in this manual may not in any event replace the medical care protocol in place for the pat...

Страница 7: ...ump 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...

Страница 8: ...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 cas...

Страница 9: ...esistive 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...

Страница 10: ...erence 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 packag...

Страница 11: ...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 p...

Страница 12: ...e 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...

Страница 13: ...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 prot...

Страница 14: ...t 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...

Страница 15: ...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 L5...

Страница 16: ...also protects the SO FILL syringe Warning Thematerials used for theprotectivecases havenot been tested for biocompatibility with theskin Do not wear theprotectivecase against the body 1 Insert the SO...

Страница 17: ...D 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...

Страница 18: ...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...

Страница 19: ...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 D...

Страница 20: ...e 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 complet...

Страница 21: ...p 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 wit...

Страница 22: ...at the battery compartment cover is not damaged or missing and that the battery has been installed correctly Takecaretoinsert thebatteryintherightdirection Insertingthebatteryinthewrongdirectioncouldd...

Страница 23: ...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...

Страница 24: ...essionals may not disclose to thepatient the passwordsor any other informationlikely to enable the patient to gain access to the programming and configuration functions of the SO CONNECT PID pump Inco...

Страница 25: ...tions Press Parameters The pump will display the first setup tab Time Date and Date format Press or to return to the main screen There are three tabs for accessing the different settings Time Date and...

Страница 26: ...e change make sure the time setting is changed accordingly Date format setting When the SO CONNECT PID pump displays the time date and date format setting tab press the date format to modify it The SO...

Страница 27: ...setting When the SO CONNECT PIDpump displays the language setting tab Press the language to modify it Press or to return to the main screen The SO CONNECT PID pump will display the list of available l...

Страница 28: ...ONNECT PID pump always displays the setup of the previous infusion The infusion setup is carried out from the main screen Press to open the menu for additional functions Press Infusion Config After en...

Страница 29: ...residual rate name of the medication used for the treatment The SO CONNECT PID pump displays the first patient information screen Press to return to the main screen Press to go to the next screen By d...

Страница 30: ...ess to confirm and return to the previous screen Entering the first name SO CONNECT PID pump displays the patient information screen press the surname to modify it SO CONNECT PID wil display the alpha...

Страница 31: ...acknowledge the message Entering the number of sites Comments The number of sites is only used as an indication for clinical follow up This date is not taken into account for the calculation of the in...

Страница 32: ...ation SO CONNECT PID pump displays the patient information screen Press the name of the medication to modify it SO CONNECT PID wil display the alphabetical keypad for entering the name of the medicati...

Страница 33: ...ng to the one you are going to use for the infusion The movements of the pusher of the pump are calibrated to match the type of syringe Selecting the wrong type of syringe can prevent the infusion fro...

Страница 34: ...n to enter the flow rate Press the graph to select the infusion rate Adjust the value with and Press to cancel and return to the previous screen Press to confirm and return to the previous screen Ente...

Страница 35: ...ation The pump will display the first setup tab Time Date and Date format Press Initialization to initialize patient information and infusion parameters Press to return the main screen After pressing...

Страница 36: ...36 Part IV Syringe and infusion set This part of the user s manual contains the following information SO FILL syringes infusion set...

Страница 37: ...he SO FILL syringes if the packaging is damaged The SO FILL syringes are supplied in a sterile condition and can only be used once SO FILL syringes may not be re sterilised While handling the syringe...

Страница 38: ...ing the syringe 2 Check the correct tightening between the plunger and the piston 3 Push the plunger back and forth to uniformly lubricate the silicone inside the body of the SO FILL syringe 4 To fill...

Страница 39: ...ter filling the SO FILL syringe clip the protective cap to avoid injury 9 Unscrew the safety needle or the spike from the SO FILL syringe counterclockwise 10 Unscrew the plunger counterclockwise 11 Re...

Страница 40: ...with the SO CONNECT PID pump and SO FILL syringes small internal tube volume optimum 0 1 ml maximum 0 62 ml tube that does not exceed 90 cm length anti throttle tube Warning The use of an unsuitable i...

Страница 41: ...n Warning Always work in aseptic conditions in order to minimise the risk of infection Caution Apomorphine will stain clothes and other items Before selecting an infusion site please consult the patie...

Страница 42: ...ing information starting an infusion infusion control screen infusion control menu pausing the infusion restarting the infusion modifying the flow rate or the duration of the infusion End of infusion...

Страница 43: ...rt is carried out from the main screen Appuyez sur le bouton Nouvelle perfusion pour d marrer la perfusion Step 1 syringe type and volume checking After pressing the New infusion button the SO CONNECT...

Страница 44: ...nutes Press to return to the previous screen Pr cautions Donotblockthemovementofthepusher Thatcouldcausethe SO CONNECT PIDpumpto malfunction andactivatean occlusion alarm Step 4 installing the syringe...

Страница 45: ...and contact user support Comments In order to secure the use of the pump during an infusion the supports on the various buttons must be maintained for 2 seconds to be taken into account Infusion cont...

Страница 46: ...fusion control screen The SO CONNECT PID pump displays the second page of the infusion control menu Press or to display the first page of the infusion control menu Press to return to the infusion cont...

Страница 47: ...lashes green yellow Restarting the infusion You can restart a paused infusion Press for two seconds The SO CONNECT PID pump displays the first page of the infusion control menu Press Play for 2 second...

Страница 48: ...Appuyez sur le bouton pour revenir l cran de perfusion The SO CONNECT PID pump displays a numeric keypad to enter the password Use the keypad to enter the password Press to delete entered characters...

Страница 49: ...ess to cancel and return to the previous screen Press to confirm and return to the previous screen Modifying the duration of the infusion The SO CONNECT PID pump displays the screen to modify the flow...

Страница 50: ...for 2 seconds to cancel After confirmation the SO CONNECT PID pump displays the screen requesting removal of the syringe Press once the syringe is removed The SO CONNECT PID pump retracts the pusher T...

Страница 51: ...s the pusher This operation can take several minutes Unwanted effects After the retract of the pusher the SO CONNECT PID pump offers you if you wish to fill out the form of the end of infusion Press f...

Страница 52: ...for 2 seconds After entering the password the SO CONNECT pump displays the screen for exporting clinical data Press Stop Transfer to end the data transfer Press to stop the data transfer and return t...

Страница 53: ...SO CONNECT PID pump displays the second page of the infusion control menu Press Software Info for 2 seconds The SO CONNECT PID pump displays the internal information screen Press Or to return to the...

Страница 54: ...contains the description of the different alarms emitted by the SO CONNECT PID pump alarm system device failure alarm syringe missing alarm infusion about to end alarm end of infusion alarm occlusion...

Страница 55: ...tery life less than 30 minutes 1 minute Infusion about to end Low The infusion will end in less than 5 minutes Immediate Infusion in pause Low The infusion has been paused for more than 5 minutes Imme...

Страница 56: ...ump regularly checks if the SO FILL syringe is present When it detects that the SO FILL syringe is missing the SO CONNECT PID pump generates the syringe missing alarm When this alarm occurs the infusi...

Страница 57: ...e eliminated to prevent the administration of a post occlusion bolus which could cause serious injury If the occlusion alarm is triggered you need to contact the medical personnel in charge of your tr...

Страница 58: ...s 58 Infusion in pause low priority The SO CONNECT PID pump has a function for reminding the patient that the infusion has been paused for more than 5 minutes The infusion is not stopped when this ala...

Страница 59: ...tion of conformity This part contains information about the following Cleaning and disinfection of the pump pump inspection maintenance alarm system testing pump damage in the event of a fall or impac...

Страница 60: ...nt and its cover with a cloth moistened with Mikrozid AF or Puresept AF Wait until the disinfectant solution has dried completely before handling the SO CONNECT PIDpump Warning Never clean your SO CON...

Страница 61: ...is to say level with the pump housing Make sure that the infusion system is primed free from air bubbles and correctly connected Check that the infusion device is inserted according to the instructio...

Страница 62: ...s been designed especially for the SO CONNECT PID pump which will help avoid falls and protect it from impacts Warning Inspect the pump immediately in the event of a fall or impact DonotusetheSO CONNE...

Страница 63: ...battery compartment or the compartment of the SO FILL syringe If the battery or SO FILL syringe compartment is wet turn the SO CONNECT PID pump over to let the water drain out and leave it to dry Do...

Страница 64: ...sposal When it is in use the SO CONNECT PID pump is liable to come in contact with blood and could thus be a risk of infection As a result it is not within the scope of the European Directive 2002 96...

Страница 65: ...rty claims relating to the above 3 This guarantee may be voided if the model or serial number stated on the product have been modified erased removed or made illegible in any way 4 The guarantee does...

Страница 66: ...is intended for all users patients and medical personnel This part contains information about the following declaration of conformity pump specifications pump precision pressure level time required fo...

Страница 67: ...Partie VIII Caract ristiques techniques 67 Declaration of conformity...

Страница 68: ...Occlusion reporting time See the appendix on the Time required for reporting an occlusion Post occlusion bolus 0 5 ml Memory The infusion parameters are saved even if the battery is removed Screen TFT...

Страница 69: ...optimum precision are no counter pressure due to the size of the catheter or a height difference between the pump and the infusion site ambient temperature 25 C atmospheric pressure at sea level medic...

Страница 70: ...n d une occlusion en fonction du d bit Infusion rate Time required for reporting an occlusion 25 ml h 4 minutes et 30 secondes 50 ml h 2 minutes et 30 secondes Warning The time for activating the occl...

Страница 71: ...working of devices such as the SO CONNECT PID pump Thus the SO CONNECT PID pump must not be placed close to other devices If that is not possible monitor the pump to make sure that it is operating co...

Страница 72: ...Partie VIII Caract ristiques techniques 72...

Страница 73: ...61000 4 6 3 Vrms from 150 kHz to 80 MHz outside ISM bands Not applicable Radiated RF IEC 61000 4 3 3V m from 80MHz to 2 5GHz 10V m Note 1 Note 1 Portable and mobile RF communication devices may not be...

Страница 74: ...z to 800 MHz d 1 2 p 800 MHz to 2 5 GHz d 2 1 p 0 01 0 12 0 12 0 21 0 1 0 38 0 38 0 66 1 1 2 1 2 2 1 10 3 8 3 8 6 64 100 12 12 21 If the maximum output power of the transmitter is not indicated in the...

Страница 75: ...France D veloppement Electronique 46 Rue du Zornhoff 67700 MONSWILLER FRANCE SO CONNECT PID user s manual v2 01 EN 0459 Rev 2 01 09 08 2018...

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