SYNFUGO ™ Automated Infusion Pump Instructions for Use 1
Table of Contents Chapter 1 Important Safety Information 1.1 Important information about your SYNFUGO 1.2 Critical device use Chapter 2 Getting to Know Your SYNFUGO 2.1 Introduction 2.2 What is included in the box 2.3 Features of your SYNFUGO 2.4 Cleaning and Storage 2.5 Disposing of your SYNFUGO Chapter 3 Charging, Initial Setup, & Settings 3.1 Before turning on your SYNFUGO for the first time 3.2 Charging 3.3 Initial Setup 3.4 Main Menu 3.5 General settings 3.6 Setting default infusion rate 3.
Chapter 4 Performing an Infusion 4.1 Before you begin 4.2 Turn on your SYNFUGO and select infusion type 4.3 Scan medication vials 4.4 Prepare medication, syringe, and butterfly needle 4.5 Load syringe 4.6 Priming the system (removing air) using your SYNFUGO 4.7 Confirm that system is primed (air is removed) 4.8 Insert butterfly needle into vein and check for blood 4.9 Check for blood 4.10 Start infusion 4.11 Adjust infusion rate 4.12 Second syringe to infuse? 4.13 Infuse with second syringe 4.
Chapter 6 FAQ, Troubleshooting, Alerts and Errors, Labeling, Contact Info 6.1 Frequently asked questions 6.2 Troubleshooting 6.3 Alert and error screens 6.4 Labeling 6.5 Important contact information 65 66 69 74 82 86 Chapter 7 Technical Specifications 7.1 Environmental 7.2 Physical 7.3 Product classification 7.4 Electrical 7.5 Radio transmitter 7.6 Infusion flow rates 7.7 Scanning RFID 7.8 Charging Adapter 7.
Chapter 1 Important Safety Information
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, make sure you have been trained by your doctor or healthcare provider. • Only trained users shall use SYNFUGO.
• 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. • Sight or hearing impaired patients should only use SYNFUGO with the help of a caregiver who has been properly trained on how to use it.
1.2 Critical device use See the prescribing instructions accompanying your AFSTYLA or IDELVION for direction on the reconstitution of your medication. 8 • 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. • DO NOT use your SYNFUGO if you experience a problem and cannot resolve the issue using Chapter 6.2 Troubleshooting.
• 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. • DO NOT allow your SYNFUGO to become submerged or wet. It is an electronic device and may be damaged if submerged or exposed to excessively wet conditions. • DO NOT attempt to use your SYNFUGO while it is charging.
1.3 • 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. • The battery in your SYNFUGO is not replaceable. Your SYNFUGO contains a non-replaceable battery. There are no user serviceable parts.
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. -Correct scanning of the vial the dose IU SYNFUGO will display the sum of the scanned IU of the vials.
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 provider or pharmacy. • Only use your SYNFUGO with Becton Dickinson (BD) 5 mL (catalog # 309646) and 10mL (catalog #309604) plastic syringe.
• 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 5. • If connected with the SYNFUGO mobile app, the date and time will automatically be set.(Chapter 5) • SYNFUGO is for patients greater than 2 years of age and diagnosed with Hemophilia A or B, who are trained in manual infusions.
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: A SYNFUGO infusion pump B Charging 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 separately from your Doctor, health care provider, or pharmacy.
A B C D E 15
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 for additional information). A Charging Port: Receives the Charging Cable. B Display: Displays all device settings and information. C Power Button : Press to turn your SYNFUGO’s power on and off.
K Syringe 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.
2.4 Cleaning and storage 18 • 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. • Alcohol wipes (70% 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.
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. • 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.
• 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.
Chapter 3 Charging, Initial Setup, and Settings
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 to 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.
To charge your SYNFUGO: 1 Insert the Charging Cable and Charging Adapter into a 110V AC outlet. Only 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 must be oriented correctly before inserting. NOTE: If charged, turn on by pressing the power button.
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.
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. To save battery capacity, always turn off SYNFUGO after use. If not used within 20 minutes, SYNFUGO will turn off automatically to save battery capacity.
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. The mobile app will set the date and time automatically e.g., in case of traveling and daylight savings time changes.
2 Enter Name Use Navigation Buttons to select each letter, then press Ok/Confirm to 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 Ok/Confirm to save. Your name will be shown when turning the device on. Make sure it is your personally named SYNFUGO before using the device.
3 Set Time Format Use Navigation Buttons to select preferred time format, then press Ok/Confirm to 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. If you have paired your SYNFUGO pump to a mobile device, it will be updated to the time of the mobile device.
4 Set Hour Use Navigation Buttons the current hour, then press Ok/Confirm to confirm. 5 Set Minutes Use Navigation Buttons the current minute, then press Ok/Confirm to confirm.
6 Set Year Use Navigation Buttons the current year, then press Ok/Confirm to confirm. to select This concludes the initial setup, your SYNFUGO should now have returned to the Main Menu. 7 Set Month Use Navigation Buttons the current month, then press Ok/Confirm to confirm.
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8 Set Day Use Navigation Buttons the current day, then press Ok/Confirm to confirm.
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. • Bleed: Select to perform an infusion in response to a bleed event. (or on-demand) • Bleed Follow-Up: Select to perform a bleed follow-up infusion. • History: Select to access infusion history.
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. 1 Use Navigation Buttons Settings, then press Ok/Confirm to confirm.
34 2 Use Navigation Buttons to select the desired category, then press Ok/Confirm to confirm. 3 Follow further prompts to adjust any settings.
3.6 Setting default infusion rate After selecting and confirming Settings from the Main Menu: 1 Use Navigation 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 governed by local regulatory agency approvals (10 mL per minute in U.S.), and is encoded on each drug vial.
3 Use Navigation Buttons to select the default infusion rate, then press Ok/Confirm to 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 vial information, but choose to perform infusions manually. This selection is available to you by selecting INFUSION MODEand then turning the RECORDING ONLY/NO INFUSION selector to ON.
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. 1 Use Navigation Buttons Infusion Mode, then press Ok/Confirm to select to confirm To enable recording only select “On”.
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.
Chapter 4 Performing an Infusion
4.1 Before you begin 40 • 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. • If this is an emergency treatment and the device is not sufficiently charged, do not use the device and perform the infusion manually according to the medication instructions.
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. 1 Press and hold Power SYNFUGO. to turn on A welcome screen will now appear. This will disappear after a few seconds and be replaced by the main menu screen.
3 Press the Ok/Confirm infusion type. to confirm the 4.3 Scan 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. NOTE: Scanning the same vial twice will generate an error.
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.
2 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. 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.
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. Vial scanning will only work for vials that include this feature- Only vials with an "RFID" logo on the box will work with SYNFUGO.
4.4 Prepare medication, syringe, and butterfly needle 1 Reconstitute medication and prepare your infusion using the instructions provided with medication. Attach butterfly needle. 2 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. (Chapter 4.7) WARNINGS: Only 5mL and 10mL syringes provided with medication are compatible. Prime (remove air from) the syringe and butterfly needle.
4.5 Load syringe Ensure that butterfly needle is securely attached to syringe. 1 Slide the Lock Release to open your SYNFUGO.
WARNING 2 48 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.
3 Load syringe and butterfly needle into your SYNFUGO. Confirm that the syringe is seated 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, confirm that the syringe selector is set to the proper size for the syringe you are using.
4.6 Priming the system (removing air) using your SYNFUGO SKIP THIS STEP IF THE SYSTEM HAS ALREADY 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 50 Push the Grey Tab toward the syringe until you see the air has been removed and a drop of medication exit the needle. Check that all air has been removed.
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.
4.7 Confirm that system is primed (air is removed) 1 If all air has been removed from the syringe and butterfly needle, use Navigation Buttons 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 proper technique to clean your skin, insert needle into vein using butterfly as per manual infusion training. Press Ok/Confirm when done.
4.9 Check for blood NOTE: Location of needle is only an example, place as per your training.
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 the Grey Tab. If blood is not seen, the needle may not be in the vein. The needle may need to be reinserted. NOTE: The 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 the infusion.
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. Press Ok/Confirm to resume. NOTE: If you want to end the infusion, press the Back Button and select Yes to end the infusion.
4.11 Adjust infusion rate (if necessary) Use Navigation Buttons infusion rate during infusion. to adjust 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.
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: 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. 1 2 If there is NOT a second syringe to infuse: Use Navigation Buttons to select No, then press Ok/Confirm . Continue to Chapter 4.
4.13 Infuse with second syringe (if necessary) NOTE: Do not remove the needle from your 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 second syringe must be primed manually (by hand) and cannot be primed with your SYNFUGO.
3 You will now see this screen: 4 Remove the first syringe from your SYNFUGO, then detach the butterfly needle from the first syringe and attach 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 before you can continue. 6 See Chapter 4.10 in order to infuse the second syringe. For help, please refer to earlier sections of this chapter.
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. 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.
Chapter 5 Using your SYNFUGO with Mobile and Web apps
62 • The 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 PlayTM store and the Apple App StoreTM respectively. • The SYNFUGO mobile app may also be used to scan medication info and provide calendar reminders for your scheduled infusions.
• 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 <>. Information on software features, functions and limitations may be found there. NOTE: If you choose to pair to the mobile app, your SYNFUGO will automatically have the time and date updated to the info on the mobile device.
Chapter 6 FAQ, Troubleshooting, Alerts and Errors, Labeling, and Contact Info
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.
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. You may also adjust the rate during an infusion by pressing the [up/down] navigation buttons.
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 the SETTINGS menu, 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 to the main menu and you can manually infuse. If you change your mind, you can turn this feature to OFF and use SYNFUGO to perform your infusion.
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 1-800-878XXXX. Problem Unable to turn your SYNFUGO on by pressing Power . Cause Power enough. was not pressed long Solution Firmly depress the Power Cause Battery is not charged. Solution Recharge your SYNFUGO until the display shows charging complete.
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 and remove 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 to scan a medication that is not AFSTYLA or IDELVION Solution Only use AFSTYLA or IDELVION with your SYNFUGO.
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. Solution Do not attempt to scan more than 4 medication vials. Cause You are holding your SYNFUGO too far away from the medication vial. Solution Touch the top of SYNFUGO to the medication vial while scanning.
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 for details. Cause The wrong syringe type is used. Solution Your SYNFUGO is only designed for use with the Becton Dickenson 5mL (cat #309646) and 10mL (cat #309604) syringes provided with your medication.
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. Cause There is debris in the Syringe Cradle preventing the syringe from seating properly. Solution Remove debris from the Syringe Cradle.
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 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 74 1 Remove the syringe from your SYNFUGO and complete the infusion manually. 2 Charge your SYNFUGO using the supplied charger until fully charged.
Syringe Removed Reason The syringe has been removed during infusion, user is instructed to complete manually.
Device Expired Reason The lifetime 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 SYNFUGO per local regulation.
Fatal Error Reason A fatal error has occurred. 1 How to Resolve Remove the syringe from your SYNFUGO and complete the infusion manually. 2 Replace your SYNFUGO. 3 Note the error code. And contact customer service.
Occlusion Reason The flow of your medication has been blocked, so your SYNFUGO has stopped working. 1 78 How to Resolve Press Ok/Confirm .
2 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 Ok/Confirm . You will now be returned to the 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 manually), then press Ok/Confirm and proceed to Step 3. 3 You will now see this screen.
4 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. If the occlusion condition cannot be resolved, proceed with manual infusion.
Disconnect USB Cable You may also see a yellow warning such as the one above.
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 date (DD), printed as YYYYMM-DD. Keep your SYNFUGO dry.
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 and contribute to the prudent and rational use of natural resources.
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.
Your SYNFUGO can be stored at a relative humidity range from 15-90% RH IP20 SYNFUGO is protected against 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.
6.5 Important contact information If you experience any problems or malfunctions with your SYNFUGO you may report the issue to the FDA or to CSL Behring.
Chapter 7 Technical Specifications
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 • 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.
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 • If maximum 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 can be scanned for each infusion 7.
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.
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% UT; 250/300 cycle IEC 61000-4-11 0% UT; 0,5 cycle, At 0°, 45°, 90°, 135°, 180°, 225°, 270°, 315° 0% UT; 1 cycle, 70% UT; 25/30 cycles Single phase: at 0° EMC - RF Field Immunity to Proximity fields from Wireless communication equipment, Immunity at 0,3m separation: a) b) c)
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.
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.
