molex Phillips Medisize SynfuGo User manual

1
SYNFUGO
™
Automated Infusion Pump
Instructions for Use

Table of Contents
Chapter 1
Important Safety Information 5
1.1 Important information about
your SYNFUGO 6
1.2 Critical device use 8
Chapter 2
Getting to Know Your SYNFUGO 11
2.1 Introduction 12
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
SYNFUGO for the first time 22
3.2 Charging 22
3.3 Initial Setup 26
3.4 Main Menu 27
3.5 General settings 33
3.6 Setting default infusion rate 35
3.7 Infusion mode 37
3.8 Syringe selector 38
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Chapter 4
Performing an Infusion 39
4.1 Before you begin 40
4.2 Turn on your SYNFUGO and
select infusion type 41
4.3 Scan medication vials 42
4.4 Prepare medication, syringe ,
and butterfly needle 46
4.5 Load syringe 47
4.6 Priming the 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 54
4.11 Adjust infusion rate 56
4.12 Second syringe to infuse? 57
4.13 Infuse with second syringe 58
4.14 Remove final syringe and needle 60
4.15 Turn off your SYNFUGO 60
Chapter 5
Using your SYNFUGO with Mobile and W eb
apps 61
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Chapter 6
FAQ, Troubleshooting, Alerts
and Errors, Labeling, Contact Info 65
6.1 Frequently asked questions 66
6.2 Troubleshooting 69
6.3 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 Electrical 88
7.5 Radio transmitter 88
7.6 Infusion flow rates 89
7.7 Scanning RFID 89
7.8 Charging Adapter 89
7.9 Pump identification 89
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Chapter 1
Important Safety Informa tion

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. If this is
your first self-administered infusion with your
SYNFUGO, 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 perfor med manual
intravenous infusions on yourself before using this
infusion pump . Manual infusions is to be performed
in case of malfunction of SYNFUGO.
• Use only with AFSTYLA or IDEL VION medication
supplied by your doctor, health care provider, or
phar macy . Using other medications can cause
unpredictable risk.
• Use only syringes and butterfly needle supplied
along with your medication. Other syringes or
butterfly needles may interfere with normal infusion
pump operation and may cause incorrect infusion
rate or dose .

• 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. To
safely see and hear information’s or alerts from the
infusion pump.
• Keep your SYNFUGO pump and all of its
accessories out of reach of children. Cables may
present a strangulation risk and risk of
suffocation/asphyxiation.
• Caution: US Federal Law restricts this infusion
pump to be for sale by or on order of a
physician.
• DO NOT use the SYNFUGO infusion pump for
patients under 2 years of age .

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.
• DO NOT use your SYNFUGO if you
experience a problem and cannot
resolve the issue using Chapter 6.2
T roubleshooting.
• DO NOT use your SYNFUGO if your
prepared syringe cannot be inserted or
removed according to the instructions for
use. Perform a manual infusion.
• DO NOT use your SYNFUGO if it has been
exposed to extreme vibration, pressure, or
shock (such as being dropped or stepped
on) as it may have been damaged.
• DO NOT use your SYNFUGO if you
observe any worn, damaged, or broken
parts, or if you hear any unusual or
unexpected sounds during use. Inspect
your SYNFUGO regularly for damage and
wear .
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• 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. Your SYNFUGO cannot
be used while charging .
• DO NOT attempt to disassemble, tamper
with, or repair your SYNFUGO. It contains
Lithium Ion batteries which could explode
or lead to severe burns and/or electrical
shock.
• DO NOT use your SYNFUGO if it has been
exposed to extreme temperatures. Keep your
SYNFUGO away from heat or fire . Keep
your SYNFUGO out of direct sunlight.
• DO NOT attempt to use any charging
adapter or charging cables other than
those included with your SYNFUGO. Other
adapters or cables may create problems
and may interfere with normal device
operation.
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• 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 .
• Always scan all vials needed for the infusion
prior to beginning the infusion.
1.3 Intended use
SYNFUGO, is intended for the following use:
1. For use with reconstituted drug (AFSTYLA and IDELVION) in
a user filled syringe.
2. To be used in the intravenous administration of
reconstituted drug solution through controlled infusion
rates.
3. To be used as a portable personal syringe infusion pump in
home environment.
4. Re-usable, personal device for one specific patient to be
used by the adults, adolcents and children.

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.
Electromagnetic disturbance may result in wrong readings,
always make sure the scanned IU is correct.
Chapter 2
Getting to Know Y our
SYNFUGO

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 car e
provider or pharmacy.
• Only use your SYNFUGO with Becton
Dickinson (BD) 5 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
contacting customer service .
• Only use your SYNFUGO with NIPRO
brand SafeTouch PSV 25G x 3/4” x 350mm
long butterfly needles. Any changes to
compatible syringes made after date
of publication may be confirmed using
CSL Behring SYNFUGO website or by
contacting customer service .
• Your SYNFUGO can record and store the
patient´s infusion information and enables
easy patient´s access to his/her complete
infusion and medication histor y .
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• 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 .
• 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
caregiver must be available to super vise
or assist (as needed) with the use of
SYNFUGO .
• Patients 12 years of age and older, who
can independently perform a manual
infusion, can self-infuse using SYNFUGO
if trained.
• Patients under the age of 2 must not use
the SYNFUGO infusion pump .
• Applied parts (part that comes in contact to
the skin) is the Butterfly Needle .
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2.2 What is included in
thebox
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 NO T
INCLUDED in this kit and will be
supplied separately from your Docto r ,
health care provider, or pharmacy.
Note: The optional software for your
SYNFUGO (mobile and web apps) are
not included. See Chapter 5 for more
infor mation.
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A
B
C
D
E
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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 infor mation).
A Charging Port: Receives the Charging
Cable .
B Display: Displays all device settings and
infor mation.
C Power Button : Press to turn your
SYNFUGO’s power on and of f .
D Back Button : Use to step back to
previous selection.
E Navigation Buttons : Use to
navigate up or down through the display
menu.
F Ok/Confirm Button : Use to confirm
a desired input selection.
G Stop/Emergency Stop Button : Use
to immediately stop an infusion.
H Grey Tab: Manually move plunger to
Remove air or check for blood.
I Lid Release: Use to unlock and open lid
and access syringe .
J
Vial Scanner Target: Use to scan and
record vial infor mation.
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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 .
J
A
C
D
B E
I F
H G
M
K
L
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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.
• 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 .
• Always store your SYNFUGO with the lid
closed and in its storage case to protect it
from dust, dirt, or direct sunlight.
• Keep SYNFUGO away from heat, fire, and
extreme temperatures .
• Keep your SYNFUGO out of direct sunlight.
• Keep SYNFUGO and all of its accessories
out of reach of children. Cables may
present a strangulation risk.
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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 .
• Always dispose of your empty syringe and
used butterfly needle immediately after you
completed your infusion into an appropriate
sharps container .
• Your used SYNFUGO device, charging
adapter and micro USB cable are to be
disposed of safely according to WEEE
regulation (requirement in Europe).
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• 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.
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