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molex Phillips Medisize SynfuGo Instructions For Use Manual

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SYNFUGO
Automated Infusion Pump
Instructions for Use
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Summary of Contents for molex Phillips Medisize SynfuGo

  • Page 1 ™ SYNFUGO Automated Infusion Pump Instructions for Use...

  • Page 2: Table Of Contents

    Table of Contents Chapter 1 Important Safety Information Important information about your SYNFUGO Critical device use Chapter 2 Getting to Know Your SYNFUGO Introduction What is included in the box Features of your SYNFUGO Cleaning and Storage Disposing of your SYNFUGO Chapter 3 Charging, Initial Setup, &...
  • Page 3 Chapter 4 Performing an Infusion Before you begin Turn on your SYNFUGO select infusion type Scan medication vials Prepare medication, syringe, and butterfly needle Load syringe Priming the system (removing air) using your SYNFUGO Confirm that system is primed (air is removed) Insert butterfly needle into vein and check for blood...
  • Page 4 Chapter 6 FAQ, Troubleshooting, Alerts and Errors, Labeling, Contact Info Frequently asked questions Troubleshooting Alert and error screens Labeling Important contact information Chapter 7 Technical Specifications Environmental Physical Product classification Electrical Radio transmitter Infusion flow rates Scanning RFID Charging Adapter Pump identification...

  • Page 5: Important Safety Information

    Chapter 1 Important Safety Information...

  • Page 6: Important Information About Your Synfugo

    1.1 Important information about your SYNFUGO • Read these instructions entirely before you use your SYNFUGO infusion pump for the first time, to quickly resolve any issues using SYNFUGO. Keep these instructions in a safe and easily accessible place. • Before you use your SYNFUGO for the first time,...
  • Page 7 • Refer to the instructions for use of your AFSTYLA or IDELVION medication for directions on how to prepare it for use with your SYNFUGO infusion pump. • Check expiration dates on medication and accessories before using. Do not use the medication beyond the expiration date printed on the vial labels.

  • Page 8: Critical Device Use

    1.2 Critical device use See the prescribing instructions accompanying your AFSTYLA or IDELVION for direction on the reconstitution of your medication. • DO NOT use your SYNFUGO if it does not operate as described in this instruction manual. If you require further assistance please refer to the contact information in Chapter 6.5.
  • Page 9 • DO NOT use your SYNFUGO if you are exposed to environments with excessive noise and/or distractions that may impact your ability to use your SYNFUGO. • DO NOT use your SYNFUGO in areas with high oxygen levels, such as when supplemental oxygen is in use.
  • Page 10 • DO NOT expose SYNFUGO to any kind of MRI, X-ray, CT, or Ultrasound. • DO NOT use your SYNFUGO close to or stacked with other electrical equipment. • Portable RF communications equipment, including antennas, can effect medical electrical equipment. Always keep a minimum distance of 12 inches (30 cm) to RF equipment such as mobile phones, WIFI transceivers, etc.

  • Page 11: Getting To Know Your Synfugo

    1.4 Essential performance -Reverse plunger movement of more than 1mL SYNFUGO will prevent the plunger being moved more than 1mL backwards to prevent unintended air in the syringe. Always check that all air in the syringe is removed, electromagnetic disturbance (e.g. from mobile phones) may result in unintended reverse plunger movement.

  • Page 12: Introduction

    2.1 Introduction • Your SYNFUGO is a personal automated infusion pump that allows hands-free infusion with user controlled infusion speed. • Your SYNFUGO is a home use device with dedicated charging adapter and micro USB cable, for use by patients or caregivers. Only use your SYNFUGO with AFSTYLA or IDELVION medication as supplied by your doctor, health care...
  • Page 13 • Optionally, your infusion record can be transferred to mobile or web apps. If you choose, you may also share your infusion history with your healthcare provider- see Chapter • If connected with the SYNFUGO mobile app, the date and time will automatically be set.(Chapter •...

  • Page 14: What Is Included In The Box

    2.2 What is included in the box Before starting, check that all items listed are present. Your SYNFUGO infusion pump kit contains the following items: SYNFUGO infusion pump Charging adapter Charging cable 1m Quick Start Guide Instructions For Use (IFU) Storage case (not shown) Your medication, syringe(s) and butterfly needle(s) ARE NOT...

  • Page 16: Features Of Your Synfugo

    2.3 Features of your SYNFUGO Study the features listed below before attempting to use your SYNFUGO. If you have any questions regarding these features, consult with your doctor, health care provider, or pharmacist first. You may also contact one of our technical specialists for assistance (See Chapter 6.5 additional information).
  • Page 17 Syringe Cradle: Receives and retains your 5mL or 10mL syringe. Syringe Selector: Use to select a 5mL syringe or 10mL syringe size. Syringe Window: Use to visually monitor the syringe volume.

  • Page 18: Cleaning And Storage

    2.4 Cleaning and storage • Always keep your SYNFUGO clean and free of any dirt and debris. • If medicine or other fluid is spilled or leaked onto your SYNFUGO, be sure to clean it off immediately. • To clean your SYNFUGO, wipe carefully with a dry or slightly damp cloth and mild detergent.

  • Page 19: Disposing Of Your Synfugo

    2.5 Disposing of your SYNFUGO • Your SYNFUGO contains Lithium Ion batteries. Dispose of this device according to your local environmental laws and guidelines. • DO NOT dispose of in fire. Your SYNFUGO contains Lithium Ion batteries which could explode when exposed to fire or extreme heat.
  • Page 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.

  • Page 21: Charging, Initial Setup, & Settings

    Chapter 3 Charging, Initial Setup, and Settings...

  • Page 22: Before Turning On Your Synfugo For The First Time

    3.1 Before turning on your SYNFUGO for the first time Before turning on your SYNFUGO for the first time, you will need to charge it. Refer Chapter 3.2 for charging instructions. 3.2 Charging Your SYNFUGO will need to be charged before the first time you use it, or when the low battery warning appears on the screen.
  • Page 23 To charge your SYNFUGO: Insert the Charging Cable Charging Adapter into a 110V AC outlet. Only use supplied cable and adapter. Insert the Charging Cable into the Charging Port on the device to begin charging. Your SYNFUGO will not work while charging.
  • Page 24 You will know that your SYNFUGO charging when you see this screen. When charging is complete, you will see this screen and a full green battery symbol.
  • Page 25 A typical charge from a low battery should take no longer than 3 hours. With typical use, the battery should last for at least 10 infusions before recharging is needed. At low temperatures, the battery capacity is reduced and the battery may need to be charged more frequently.

  • Page 26: Initial Setup

    3.3 Initial setup WARNING: Make sure the date and time is correct before using. If not correct, go to settings and set correct date and time before use. If you are using the SYNFUGO mobile app, please connect your infusion pump to the mobile app.
  • Page 27 Enter Name Navigation Buttons to select each letter, then press Ok/Confirm confirm the letter. Repeat this process 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...
  • Page 28 Set Time Format Navigation Buttons to select preferred time format, then press to confirm. Ok/Confirm NOTE: The 12 hr format is more common in the USA than the 24 hr format. If you are not familiar with or do not specifically need the 24 hr format, the 12 hr format is recommended.
  • Page 29 Set Hour Navigation Buttons to select the current hour, then press to confirm. Ok/Confirm Set Minutes Navigation Buttons to select the current minute, then press to confirm. Ok/Confirm...
  • Page 30 Set Year Navigation Buttons to select the current year, then press to confirm. Ok/Confirm This concludes the initial setup, your SYNFUGO should now have returned to the Main Menu. Set Month Navigation Buttons to select the current month, then press to confirm.
  • Page 32 Set Day Navigation Buttons to select the current day, then press to confirm. Ok/Confirm...

  • Page 33: Main Menu

    3.4 Main menu Your SYNFUGO will display the Main Menu after you turn the power on or when an infusion is complete, and when you are finished adjusting settings. The following is a description of the Main Menu items. • Prophylactic: Select to perform a prophylactic (or scheduled) infusion.

  • Page 34: General Settings

    3.5 General settings Using the Settings menu you may change 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.
  • Page 35 Navigation Buttons to select the desired category, then press to confirm. Ok/Confirm Follow further prompts to adjust any settings.

  • Page 36: Setting Default Infusion Rate

    3.6 Setting default infusion rate After selecting and confirming Settings from the Main Menu: Navigation Buttons to select Infusion, then press Ok/Confirm confirm. Navigation Buttons to select Rate, then press Infusion to confirm. The maximum Ok/Confirm infusion rate for your SYNFUGO governed by local regulatory agency approvals (10 mL per minute in U.S.), and...
  • Page 37 Navigation Buttons to select the default infusion rate, then press to confirm. Ok/Confirm WARNING: The maximum infusion rate is determined 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...

  • Page 38: Infusion Mode

    3.7 Infusion Mode Choose how pump is used. SYNFUGO may be used to only scan and record the infusions without using the pump function to infuse your medication. In this case, the infusions must be performed manually. Navigation Buttons to select Infusion Mode, then press to confirm...

  • Page 39: Syringe Selector

    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.

  • Page 40: Performing An Infusion

    Chapter 4 Performing an Infusion...

  • Page 41: Before You Begin

    4.1 Before you begin • Prepare the infusion site and work surface as trained by your healthcare provider. • Make sure your SYNFUGO is sufficiently charged for the infusion. If the battery indicator is red or blinking, device should be recharged. •...

  • Page 42: Turn On Your Synfugo And Select Infusion Type

    4.2 Turn on your SYNFUGO and select infusion type WARNING: If not paired to the mobile app: Make sure the date and time is correct, if not go to settings and set correct date and time. If you have paired SYNFUGO to a mobile device, the time will update utomatically.

  • Page 43: Scan Medication Vials

    Press the to confirm the Ok/Confirm infusion type. 4.3 Scan medication vials Touch the target on top of your SYNFUGO to each vial to be scanned. Scan each vial one at a time. As you scan each vial, you will hear a beep confirming that the vial has been scanned.
  • Page 44 The total IU’s (International 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 6.2: Troubleshooting.
  • Page 45 Confirm that total IU’s is correct, then use the down Navigation Button to select All Vials Scanned. WARNING: If total IU’s on the display differs from the IU’s indicated on the labels of the medication vial(s), cancel and proceed with manual infusion instead.
  • Page 46 WARNINGS:  Always scan all vials needed for the infusion prior to beginning the infusion.  Do not 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.

  • Page 47: Prepare Medication, Syringe, And Butterfly Needle

    4.4 Prepare medication, syringe, and butterfly needle Reconstitute medication and prepare your infusion using the instructions provided with medication. Attach butterfly needle. You may either prime (remove air from) the syringe and butterfly needle manually now, OR you may use the SYNFUGO device in a later step.

  • Page 48: Load Syringe

    4.5 Load syringe Ensure that butterfly needle is securely attached to syringe. Slide the to open your Lock Release SYNFUGO.
  • Page 49 WARNING 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.
  • Page 50 Load syringe and butterfly needle into your SYNFUGO. Confirm that the syringe is seated properly and that there are no leaks anywhere. 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, confirm that the syringe selector is set to the proper...

  • Page 51: Priming The System (Removing Air) Using Your Synfugo

    4.6 Priming the system (removing air) using your SYNFUGO SKIP THIS STEP IF THE SYSTEM HAS ALREADY BEEN PRIMED MANUALLY. You will now see this screen. Note that you now need to flip your SYNFUGO over so that the syringe is pointing up. Push the Grey Tab toward the syringe until you see the air has been removed and a drop of medication...
  • Page 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.

  • Page 53: Confirm That System Is Primed (Air Is Removed)

    4.7 Confirm that system is primed (air is removed) If all air has been removed from the syringe and butterfly needle, use Navigation Buttons to select Yes. Press to confirm. Ok/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...

  • Page 54: Check For Blood

    4.9 Check for blood NOTE: Location of needle is only an example, place as per your training.

  • Page 55: Start Infusion

    Push the Grey Tab towards the screen until you see a small amount of blood in the butterfly needle just before the butterfly fitting. You will hear a tone when pushing Grey Tab. If blood is not seen, the needle may not be in the vein. The needle may need to be reinserted.
  • Page 56 stop infusion and proceed with manual infusion without using your SYNFUGO. NOTE: When the infusion is stopped, 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.

  • Page 57: Adjust Infusion Rate

    4.11 Adjust infusion rate (if necessary) Navigation Buttons 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 butterfly needle. Proceed to Chapter 6.3 for further instructions.

  • Page 58: Second Syringe To Infuse

    4.12 Is there a second syringe to infuse? Wait for infusion of first syringe to finish. If two or more vials have been scanned, you will see this screen: If there is a second syringe to infuse: Navigation Buttons to select Yes, then press Ok/Confirm...

  • Page 59: Infuse With Second Syringe

    4.13 Infuse with second syringe (if necessary) NOTE: Do not remove the needle from your vein prior to infusing with the second syringe. You will now see this screen: Manually prime second syringe (remove all air), then press to confirm Ok/Confirm that the syringe is primed.
  • Page 60 You will now see this screen: Remove the first syringe from your SYNFUGO, then detach the butterfly needle from the first syringe and attach it to the second syringe. 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...

  • Page 61: Turn Off Your Synfugo

    4.14 Remove final syringe and remove needle When you are finished infusing the final syringe, remove the syringe and dispose of properly, as directed in your medication instructions. Then remove needle from vein and apply bandage as per manual infusion training.

  • Page 62: Using Your Synfugo With Mobile And Web Apps

    Chapter 5 Using your SYNFUGO with Mobile and Web apps...
  • Page 63 • SYNFUGO infusion pump records your infusions- both the medication used and the time infused on the SYNFUGO device • You have the option to view infusion information and set up reminders with a mobile application. This application is available for Android or iOS devices through the Google Play store and the Apple App Store...
  • Page 64 • During an infusion with your SYNFUGO, the mobile app cannot be connected to your mobile device. • If you wish to take advantage of the mobile or web apps, more information may be found at the SYNFUGO information web site here <<holding space for SYNFUGO web site address here>>.

  • Page 65: Faq, Troubleshooting, Alerts

    Chapter 6 FAQ, Troubleshooting, Alerts and Errors, Labeling, and Contact Info...

  • Page 66: Frequently Asked Questions

    6.1 Frequently asked questions Question Can any syringe be used with my SYNFUGO? Answer No, only Becton Dickenson 5mL (cat #309646) and 10mL (cat #309604) syringes provided with your medication can be used with your SYNFUGO. Any changes to compatible syringes made after date of publicaton may be confirmed using the CSL Behring SYNFUGO...
  • Page 67 Answer Default Infusion rate may be changed according to patient comfort by adjusting the infusion rate in Settings (see Chapter 3.6), and is adjustable up to the maximum infusion rate for your medication. The maximum infusion rate is automatically set when your medication is scanned.
  • Page 68 Question Can I just use SYNFUGO to record the vials I've scanned and infuse manually? Answer Yes, you can- you have the option! In SETTINGS menu, select INFUSION and then INFUSION MODE. "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...

  • Page 69: Troubleshooting

    6.2 Troubleshooting NOTE: If you need assistance at any time setting up, using, or maintaining your SYNFUGO infusion device, talk with your doctor, health care provider, or pharmacy first. For Technical questions or concerns call CSL Behring anytime at 1-800-878- XXXX.
  • Page 70 Problem Unable to use your SYNFUGO while it is being charged. Cause Your SYNFUGO will not operate while it is being charged. Solution Fully charge your SYNFUGO remove the charger before using. Problem Unable to scan a medication vial. Cause You attempted to scan the same medication vial more than once.
  • Page 71 Solution Only AFSTYLA or IDELVION vials with RFID tags are compatible. Look for the RFID logo on the box. If not present, perform a manual infusion. Cause Label on medication vial is damaged. Solution Proceed with a manual infusion Cause You attempted to scan more than 4 vials.
  • Page 72 Problem Unable to close the door (NOTE: DO NOT force the door closed). Cause The syringe being used doesn’t match the setting of the Syringe Selector. Solution Set the Syringe Selector to the correct setting. See Chapter 3.7 details. Cause The wrong syringe type is used.
  • Page 73 Solution Make sure the flanges of the syringe align correctly with the slots that receive them. Cause There is 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.

  • Page 74: Alert And Error Screens

    6.3 Alert and error screens A red warning will blink to indicate an alert or error. To recover, follow the instructions and press the Ok/Confirm Button reset the alarm. Low Battery, Complete Infusion Manually Reason The battery charge is too low for your SYNFUGO to perform an infusion.
  • Page 75 Syringe Removed Reason The syringe has been removed during infusion, user is instructed to complete manually. How to Resolve Complete the infusion manually...
  • Page 76 Device Expired Reason The lifetime of the SYNFUGO is expired and the device can no longer be used. How to Resolve Request a new SYNFUGO device Complete infusion manually until a new device is recieved. Dispose the old SYNFUGO per local regulation.
  • Page 77 Fatal Error Reason A fatal error has occurred. How to Resolve Remove the syringe from your SYNFUGO and complete the infusion manually. Replace your SYNFUGO. Note the error code. And contact customer service.
  • Page 78 Occlusion Reason The flow of your medication has been blocked, so your SYNFUGO has stopped working. How to Resolve Press . You will now see Ok/Confirm this screen:...
  • Page 79 Try to correct the occlusion by making sure that the tube is not kinked, or by correcting any other .Then select Continue and then press . You will now be Ok/Confirm returned to the Infusion Progress screen (Chapter 4.10, Step 1) to continue the infusion.
  • Page 80 You will now see this screen. Push any button to return to 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.
  • Page 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...

  • Page 82: Labeling

    6.4 Labeling The following table is an explanation of the various labels found on your SYNFUGO. 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 of the indicated year (YYYY), month (MM), and...
  • Page 83 Your SYNFUGO contains electrical and electronic components and must not be disposed of using standard refuse collection. Please consult local directives/ authorities for disposal of electrical and electronic equipment. When disposing of electrical and electronic equipment by use of the collection systems available in your country, you protect the environment, human health...
  • Page 84 Your SYNFUGO complies with the requirements of The Medical Device Directive (MDD 93/42/EEC), and the RoHS (Restriction of Hazardous Substances) directive (2011/65/EU). Your SYNFUGO radiates non-ionizing electromagnetic signals. FCC ID 2AAGY-SYNFUGO Your SYNFUGO complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause...
  • Page 85 Your SYNFUGO can be stored at a relative humidity range from 15-90% RH SYNFUGO is protected against IP20 solid foreign objects of 12.5 mm Ø and greater. Only use the charging adapter and USB cable supplied with SYNFUGO which will supply the required 5V DC and 1A charging conditions.

  • Page 86: Important Contact Information

    6.5 Important contact information If you experience any problems or malfunctions with your SYNFUGO may report the 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 (Distributor)

  • Page 87: Technical Specifications

    Chapter 7 Technical Specifications...

  • Page 88: Environmental

    7.1 Environmental • The operating temperature for your SYNFUGO shall be within: 10–40°C / 50–104°F, 15-90% RH • SYNFUGO can be charged between 10–35°C / 50–95°F • The storage and transportation temperature for your SYNFUGO shall be within: -10–40°C / 14–104°F, 15-90%RH •...

  • Page 89: Infusion Flow Rates

    7.6 Infusion flow rates • Maximum defined by US Regulatory clearance: 10mL/min in the US market for AFSTYLA and IDELVION. • Selectable form 1mL/min to 10mL/min ± 15% in steps of 0.25mL/min, default setting 1mL/min • Maximum infusion pressure: 40 psi •...
  • Page 90 EMC compliance levels SYNFUGO has been tested for electromagnetic disturbances according to international standards for a home healthcare environment. The table below list the compliance levels for SYNFUGO. Electromagnetic compatibility (EMC) Basic EMC Standard Compliance levels EMC – Radiated RF Emission / Conducted IEC 60601-1-2:2014 RF Emission: CISPR...
  • Page 91 EMC - Fast transients and bursts IEC 60601-1-2: 2014 Immunity: IEC 61000-4-4 Fast transients and bursts ±2 kV ac mains IEC 61000-4-5 Surge ±1 kV Line-to-Line ac mains EMC – Voltage dips and interruptions: IEC 60601-1-2: 2014 0% U ; 250/300 cycle IEC 61000-4-11 0% U ;...
  • Page 92 Note: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications.
  • Page 93 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 SYNFUGO IFU v1.00...

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