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7.1 Environmental

•

The operating temperature for your

SYNFUGO

shall be within:

–40°C / 50–104°F, 15-90% RH

• SYNFUGO

can be charged between

–35°C / 50–95°F

•

The storage and transportation temperature
for your

SYNFUGO

shall be within:

-10

–40°C / 14–104°F, 15-90%RH

•

The operating, storage, and transportation
atmospheric pressure conditions for the
auto infuser shall be within 700 kPa and

1060 kPa.

7.2 Physical

•

Product dimensions: 163 x 56 x 38 mm

(6.4 x 2.2 x 1.5 inch)

•

Weight: Approx. 192 g (6.8 oz)

•

Expected service life: See expiry date.

7.3 Product classification

Class IIa medical device in Europe or class

II medical device in the USA.

7.4 Electrical

1 rechargeable internal Li-Ion battery, non-
replaceable.

Alert and Error sound pressure:

Typical 56 dB(A) @1m

7.5 Radio transmitter

•

Bluetooth® v4.0 @2.4GHz, customized
encrypted protocol

•

RFID @13.56MHZ

•

Class B digital device

Содержание Phillips Medisize SynfuGo

Страница 1: ...1 SYNFUGO Automated Infusion Pump Instructions for Use...

Страница 2: ...2 2 What is included in the box 14 2 3 Features of your SYNFUGO 16 2 4 Cleaning and Storage 18 2 5 Disposing of your SYNFUGO 19 Chapter 3 Charging Initial Setup Settings 21 3 1 Before turning on your...

Страница 3: ...he system removing air using your SYNFUGO 50 4 7 Confirm that system is primed air is removed 52 4 8 Insert butterfly needle into vein and check for blood 52 4 9 Check for blood 53 4 10 Start infusion...

Страница 4: ...3 Alert and error screens 74 6 4 Labeling 82 6 5 Important contact information 86 Chapter 7 Technical Specifications 87 7 1 Environmental 88 7 2 Physical 88 7 3 Product classification 88 7 4 Electric...

Страница 5: ...Chapter 1 Important Safety Information...

Страница 6: ...it should be given under the supervision of a doctor or health care provider Training will guide you using SYNFUGO safely You MUST have successfully performed manual intravenous infusions on yourself...

Страница 7: ...ng impaired patients should only use SYNFUGO with the help of a caregiver who has been properly trained on how to use it To safely see and hear information s or alerts from the infusion pump Keep your...

Страница 8: ...perience a problem and cannot resolve the issue using Chapter 6 2 Troubleshooting DO NOT use your SYNFUGO if your prepared syringe cannot be inserted or removed according to the instructions for use P...

Страница 9: ...ttempt to use your SYNFUGO while it is charging Your SYNFUGO cannot be used while charging DO NOT attempt to disassemble tamper with or repair your SYNFUGO It contains Lithium Ion batteries which coul...

Страница 10: ...Your SYNFUGO contains a non replaceable battery There are no user serviceable parts Always scan all vials needed for the infusion prior to beginning the infusion 1 3 Intended use SYNFUGO is intended...

Страница 11: ...check that all air in the syringe is removed electromagnetic disturbance e g from mobile phones may result in unintended reverse plunger movement Correct scanning of the vial the dose IU SYNFUGO will...

Страница 12: ...mL catalog 309646 and 10mL catalog 309604 plastic syringe Any changes to compatible butterfly needles made after date of publication may be confirmed using CSL Behring SYNFUGO website or by contactin...

Страница 13: ...or B who are trained in manual infusions For patients greater than 2 and less than 7 years of age a caregiver must operate SYNFUGO and perform the infusion For patients from 7 to 11 years old a careg...

Страница 14: ...g adapter C Charging cable 1m D Quick Start Guide E Instructions For Use IFU F Storage case not shown Your medication syringe s and butterfly needle s ARE NOT INCLUDED in this kit and will be supplied...

Страница 15: ...A B C D E 15...

Страница 16: ...Cable B Display Displays all device settings and information C Power Button Press to turn your SYNFUGO s power on and off D Back Button Use to step back to previous selection E Navigation Buttons Use...

Страница 17: ...Cradle Receives and retains your 5mL or 10mL syringe L Syringe Selector Use to select a 5mL syringe or 10mL syringe size M Syringe Window Use to visually monitor the syringe volume J A C D B E I F H G...

Страница 18: ...0 isopropyl may be used to clean your device DO NOT place or submerge your SYNFUGO in any liquid and do not sterilize DO NOT attempt to clean your SYNFUGO in a dishwasher Always store your SYNFUGO wit...

Страница 19: ...heat DO NOT attempt to disassemble your SYNFUGO Used butterfly needle and syringe must be disposed of with due consideration to National and Local safety and environmental regulations Always dispose...

Страница 20: ...To protect natural resources and to promote material reuse please separate packaging material from other types of waste and recycle the material through your local recycling system 20...

Страница 21: ...Chapter 3 Charging Initial Setup and Settings...

Страница 22: ...e turning on your SYNFUGO for the first time you will need to charge it Refer to Chapter 3 2 for charging instructions 3 2 Charging Your SYNFUGO will need to be charged before the first time you use i...

Страница 23: ...use supplied cable and adapter 2 Insert the Charging Cable into the Charging Port on the device to begin charging Your SYNFUGO will not work while charging Note that the plug only inserts one way and...

Страница 24: ...You will know that your SYNFUGO is charging when you see this screen When charging is complete you will see this screen and a full green battery symbol 24...

Страница 25: ...will turn off automatically to save battery capacity WARNINGS Always make sure your SYNFUGO is adequately charged before performing an infusion If the battery indicator is flashing or red the battery...

Страница 26: ...obile app please connect your infusion pump to the mobile app The mobile app will set the date and time automatically e g in case of traveling and daylight savings time changes The first time you turn...

Страница 27: ...cess until your name is complete Note that you can also delete characters or add spaces as desired When your name is complete use Navigation Buttons to select Save then press Ok Confirm to save Your n...

Страница 28: ...r format If you are not familiar with or do not specifically need the 24 hr format the 12 hr format is recommended If you have paired your SYNFUGO pump to a mobile device it will be updated to the tim...

Страница 29: ...4 Set Hour Use Navigation Buttons to select the current hour then press Ok Confirm to confirm 5 Set Minutes Use Navigation Buttons to select the current minute then press Ok Confirm to confirm 29...

Страница 30: ...lect the current year then press Ok Confirm to confirm This concludes the initial setup your SYNFUGO should now have returned to the Main Menu 7 Set Month Use Navigation Buttons to select the current...

Страница 31: ...30...

Страница 32: ...8 Set Day Use Navigation Buttons to select the current day then press Ok Confirm to confirm 31...

Страница 33: ...ettings The following is a description of the Main Menu items Prophylactic Select to perform a prophylactic or scheduled infusion Bleed Select to perform an infusion in response to a bleed event or on...

Страница 34: ...ange the date time and default infusion rate settings You may also set the pump to a RECORD ONLY mode where the pump will scan vials but the infusion may be performed manually 1 Use Navigation Buttons...

Страница 35: ...2 Use Navigation Buttons to select the desired category then press Ok Confirm to confirm 3 Follow further prompts to adjust any settings 34...

Страница 36: ...igation Buttons to select Infusion then press Ok Confirm to confirm 2 Use Navigation Buttons to select Infusion Rate then press Ok Confirm to confirm The maximum infusion rate for your SYNFUGO is gove...

Страница 37: ...ed by the prescribing information for your medication and is encoded on each vial Set Infusion Mode You may also choose to use SYNFUGO to scan and record vial information but choose to perform infusio...

Страница 38: ...infusions without using the pump function to infuse your medication In this case the infusions must be performed manually 1 Use Navigation Buttons to select Infusion Mode then press Ok Confirm to conf...

Страница 39: ...3 8 Syringe selector Inside your SYNFUGO select the correct setting for the Syringe Selector depending on whether you are using a 5mL or 10mL syringe 38...

Страница 40: ...Chapter 4 Performing an Infusion...

Страница 41: ...ce is not sufficiently charged do not use the device and perform the infusion manually according to the medication instructions Make sure that no debris is present on or inside your SYNFUGO particular...

Страница 42: ...e paired SYNFUGO to a mobile device the time will update utomatically 1 Press and hold Power to turn on SYNFUGO A welcome screen will now appear This will disappear after a few seconds and be replaced...

Страница 43: ...medication vials Touch the target on top of your SYNFUGO to each vial to be scanned 1 Scan each vial one at a time As you scan each vial you will hear a beep confirming that the vial has been scanned...

Страница 44: ...tional Units of all vials scanned will automatically update after each scan The maximum number of vials that can be scanned is four If you have any further issues with scanning vials refer to Chapter...

Страница 45: ...h manual infusion instead 3 SELECT ALL VIALS SCANNED and then Press Ok Confirm to confirm scan is complete If the total IU s is incorrect select Cancel and proceed with a manual infusion NOTE If your...

Страница 46: ...attempt to scan more than one vial at a time Do not scan empty vials If the scanning function is not working perform a manual infusion without using your SYNFUGO Vial scanning will only work for vial...

Страница 47: ...e manually now OR you may use the SYNFUGO device in a later step Chapter 4 7 WARNINGS Only 5mL and 10mL syringes provided with medication are compatible Prime remove air from the syringe and butterfly...

Страница 48: ...4 5 Load syringe Ensure that butterfly needle is securely attached to syringe 1 Slide the Lock Release to open your SYNFUGO 47...

Страница 49: ...WARNING 2 Before loading syringe confirm that the Syringe Selector switch is set to the correct syringe size 5mL or 10mL See Chapter 3 8 for more details 48...

Страница 50: ...d properly and that there are no leaks anywhere 4 Close your SYNFUGO You will now hear the motor advancing to the start position for the infusion This is normal NOTE If the lid is hard to close confir...

Страница 51: ...BEEN PRIMED MANUALLY 1 You will now see this screen Note that you now need to flip your SYNFUGO over so that the syringe is pointing up 2 Push the Grey Tab toward the syringe until you see the air ha...

Страница 52: ...WARNING Grey Tab is only intended for priming and checking blood and NOT for infusing Butterfly needle and syringe must be primed air removed either manually or with the device before infusion 51...

Страница 53: ...to select Yes 2 Press Ok Confirm to confirm NOTE Clean skin and insert needle into vein as per your training Press OK Confirm 4 8 Insert butterfly needle into vein and check for blood After following...

Страница 54: ...4 9 Check for blood NOTE Location of needle is only an example place as per your training 53...

Страница 55: ...blood check function can be limited to 1mL on the syringe there may be a slight delay before you see the plunger retracted 4 10 Start infusion 1 You will now see this screen Press Ok Confirm to start...

Страница 56: ...you may also use the Grey Tab to check for blood and ensure the needle is properly placed See also Chapter 4 9 Check for Blood If you have stopped the infusion you will see this screen Press Ok Confir...

Страница 57: ...to adjust infusion rate during infusion WARNINGS If you see this Occlusion warning screen while performing an infusion something has occurred to cause the medication to stop flowing through the butter...

Страница 58: ...there is a second syringe to infuse 1 Use Navigation Buttons to select Yes then press Ok Confirm 2 Continue to Chapter 4 13 for instructions on infusing with a second syringe If there is NOT a second...

Страница 59: ...vein prior to infusing with the second syringe 1 You will now see this screen 2 Manually prime second syringe remove all air then press Ok Confirm to confirm that the syringe is primed NOTE The secon...

Страница 60: ...ach it to the second syringe 5 Load the second syringe into your SYNFUGO and close the lid NOTE If you have already loaded the second syringe you will need to open and close the lid of your SYNFUGO be...

Страница 61: ...ing WARNING Ensure that you have received your full intended medication dose If the syringe is not fully emptied and you have not received your full medication remove syringe and complete manually 4 1...

Страница 62: ...Chapter 5 Using your SYNFUGO with Mobile and Web apps...

Страница 63: ...nfusion history and schedule using a secure cloud based Web application This feature is provided as an extension of your paper journals and is not intended to replace or supplement guidance from your...

Страница 64: ...apps more information may be found at the SYNFUGO information web site here holding space for SYNFUGO web site address here Information on software features functions and limitations may be found ther...

Страница 65: ...Chapter 6 FAQ Troubleshooting Alerts and Errors Labeling and Contact Info...

Страница 66: ...r date of publicaton may be confirmed using the CSL Behring SYNFUGO website or by contacting customer service Question Can other medications be used with my SYNFUGO Answer No use only Afstyla or IDELV...

Страница 67: ...also adjust the rate during an infusion by pressing the up down navigation buttons Question How do I determine what syringe size to set on my SYNFUGO Answer Always verify your Syringe Selector setting...

Страница 68: ...select INFUSION and then INFUSION MODE Set RECORDING ONLY NO INFUSION to ON When using the pump to scan information for your vial s wil be recorded and when all vials have been recorded you ll return...

Страница 69: ...armacy first For Technical questions or concerns call CSL Behring anytime at 1 800 878 XXXX Problem Unable to turn your SYNFUGO on by pressing Power Cause Power was not pressed long enough Solution Fi...

Страница 70: ...e the charger before using Problem Unable to scan a medication vial Cause You attempted to scan the same medication vial more than once Solution Only scan each medication vial once Cause You attempted...

Страница 71: ...ion Proceed with a manual infusion Cause You attempted to scan more than 4 vials Solution Do not attempt to scan more than 4 medication vials Cause You are holding your SYNFUGO too far away from the m...

Страница 72: ...r SYNFUGO is only designed for use with the Becton Dickenson 5mL cat 309646 and 10mL cat 309604 syringes provided with your medication If your syringe is a different brand or style STOP IMMEDIATELY an...

Страница 73: ...s debris in the door latch area preventing the door from closing Solution Check the hinges latch area and insides of both covers for debris Remove and clean as necessary Cause There is debris in the S...

Страница 74: ...ress the Ok Confirm Button to reset the alarm Low Battery Complete Infusion Manually Reason The battery charge is too low for your SYNFUGO to perform an infusion How to Resolve 1 Remove the syringe fr...

Страница 75: ...Syringe Removed Reason The syringe has been removed during infusion user is instructed to complete manually How to Resolve Complete the infusion manually 75...

Страница 76: ...ifetime of the SYNFUGO is expired and the device can no longer be used How to Resolve 1 Request a new SYNFUGO device 2 Complete infusion manually until a new device is recieved 3 Dispose the old SYNFU...

Страница 77: ...Error Reason A fatal error has occurred How to Resolve 1 Remove the syringe from your SYNFUGO and complete the infusion manually 2 Replace your SYNFUGO 3 Note the error code And contact customer servi...

Страница 78: ...Occlusion Reason The flow of your medication has been blocked so your SYNFUGO has stopped working How to Resolve 1 Press Ok Confirm You will now see this screen 78...

Страница 79: ...he Infusion Progress screen Chapter 4 10 Step 1 to continue the infusion If you do NOT think that you can correct the occlusion select Complete meaning that you intend to complete the infusion manuall...

Страница 80: ...the Main Menu In case of an occlusion SYNFUGO will automatically release the pressure Once the occlusion condition is removed you will need to start SYNFUGO to continue the infusion If the occlusion c...

Страница 81: ...Disconnect USB Cable You may also see a yellow warning such as the one above In this case follow the instructions on the screen 81...

Страница 82: ...Label Description It is important that you read this instruction before you use your SYNFUGO This symbol is accompanied by an expiry date to indicate that the device should not be used after the end...

Страница 83: ...c equipment When disposing of electrical and electronic equipment by use of the collection systems available in your country you protect the environment human health and contribute to the prudent and...

Страница 84: ...th part 15 of the FCC Rules Operation is subject to the following two conditions 1 This device may not cause harmful interference and 2 this device must accept any interference received including inte...

Страница 85: ...humidity range from 15 90 RH IP20 SYNFUGO is protected against solid foreign objects of 12 5 mm and greater Only use the charging adapter and USB cable supplied with SYNFUGO which will supply the requ...

Страница 86: ...issue to the FDA or to CSL Behring If you have any technical questions or concerns about your SYNFUGO infusion pump you may contact one of our technical specialists at the number below CSL Behring Di...

Страница 87: ...Chapter 7 Technical Specifications...

Страница 88: ...or the auto infuser shall be within 700 kPa and 1060 kPa 7 2 Physical Product dimensions 163 x 56 x 38 mm 6 4 x 2 2 x 1 5 inch Weight Approx 192 g 6 8 oz Expected service life See expiry date 7 3 Prod...

Страница 89: ...um pressure is achieved an occlusion alarm is generated Occlusion alarm will occur within 60 seconds at minimum flow rate 1mL min 7 7 Scanning RFID Reading distance 0 8inch 2cm A maximum of 4 vials ca...

Страница 90: ...11 Group 1 RF emissions CISPR 11 Class B Radiated Emission 30 MHz 1 GHz Conducted emission 150kHz 30MHz IEC 60601 1 2 2014 CISPR 11 2019 A1 2010 EMC RF Field radiated immunity Electrical field 10 V m...

Страница 91: ...le 70 UT 25 30 cycles Single phase at 0 IEC 60601 1 2 2014 IEC 61000 4 11 EMC RF Field Immunity to Proximity fields from Wireless communication equipment Immunity at 0 3m separation a 27 V m at 380 39...

Страница 92: ...adio communications However there is no guarantee that interference will not occur in a particular installation If this equipment does cause harmful interference to radio or television reception which...

Страница 93: ...90 Manufactured by Gimsinglundvej 20 DK 7600 Struer Denmark Distributed by Phone 0800 1810798 1020 First Avenue PO Box 61501 King of Prussia PA 19406 0901 USA SYNFUGO IFU v1 00...

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