Fist Assist FA-1 User manual

Instructions for Use
Fist Assist Model FA-1
www.fistassistdevices.com
www.fistassistusa.com

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Contents
Warnings 4
Precautions 8
List of Symbols and Abbreviations 10
Indications for Use 11
Risks and Benefits 11
System Overview 13
Description 13
Components 14
Set Up, Proper Operation, and Use 16
Step 1: Unpack the Device 16
Step 2: Install the Batteries 17
Step 3: Check for Proper Operation 18
Step 4: Use of the Device 19
Positioning the Device 21
Applied just below the elbow 21
Applied just below the shoulder 21
Indicator LED 22
Audio Indicator 22
Storage and Cleaning 23
Storage 23
Cleaning 23
Technical Specifications 25
List of Technical Specifications 25
Battery Service Life 27
Operation Modes 28
Electromagnetic Compatibility 28

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Classification and Standards 28
Manufacturer’s Declaration Table 28
General Notes 28
Guidance & Manufacturer’s Declaration-
Electromagnetic Immunity 30
Recommended Separation Distances 31
Troubleshooting 33
Contacting Fist Assist Devices, LLC 35
Manufacturer Contact and Ordering Information 35
Technical Support 36
Disposal 36
Warranty 36
Return Goods Policy 38
Limitations of Liability 39

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•
Warnings
Note:Failure to observe one or more of the
following warnings could compromise safety or
result in ineffective therapy.
Note: Review this Instructionsfor Use (IFU) prior to
use. If there are additional questions after reading
this IFU, or you suspect the device may not be
operating properly, discontinue its use and contact
Fist Assist Devices, LLC
The Fist Assist Model FA-1 device is only to be
used by adults only who are capable of
applying and removing the device without
assistance.
Warningor Safety sign
Consideration of hazards
Possible hazard the
warning/safety sign is
intended to avoid and
likely consequences that
could occur if the advice
is not followed
Do Not Dissassemble the Fist
Assist Model FA-1 Device.
An improperly re-assembled
device might provide no
therapy or insufficient
therapy

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Fist Assist Devices, LLC
recommends that all users who will
be operating the Fist Assist Model
FA-1, review this Instructions For
Use (IFU) prior to use. Ifthere are
additional questions after reading
this IFU, contact Fist Assist
Devices, LLC.
Improper use of the device
might provide no therapy or
insufficient therapy
Fist Assist Devices, LLC
recommends that all users who will
be operating the Fist Assist Model
FA-1, review this Instructions For
Use (IFU) prior to use. Ifthere are
additional questions after reading
this IFU, contact Fist Assist
Devices, LLC.
Improper use of the device
might cause discomfort
During setup, ensure that the
batteries are installed with the
proper polarity as indicated in the
battery compartment.
Improper installation of the
batteries will cause the
device to provide no therapy
The Fist Assist Model FA-1
should not be used adjacent to
other equipment. If adjacent use is
necessary, the user is to insure
proper operation with the adjacent
equipment before use.
The unit might make the
adjacent equipment
malfunction
Portable and mobile RF
communications equipment can
The device might
malfunction provide no
therapy or insufficient
therapy

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negatively affect the performance
of the Fist Assist Model FA-1
The device might
malfunction and operate in
such a way as to cause
discomfort
Portable RF communications
equipment (including peripherals
such as antenna cables and
external antennas) should be used
no closer than 30cm (12 inches) to
any part of the Model FA-1.
Otherwise, degradation of the
performance of this equipment
could result.
The device might
malfunction provide no
therapy or insufficient
therapy
The device might
malfunction and operate in
such a way as to cause
discomfort
Use of accessories,
transducers and cables other than
those specified or provided by the
manufacturer of this equipment
could result in increased
electromagnetic emissions or
decreased electromagnetic
immunity of this equipment and
result in improper operation.
The device might
malfunction provide no
therapy or insufficient
therapy
Replace the batteries if the
low battery indicator is activated
(orange colored LED illumination).
The device might provide no
therapy or insufficient
therapy if the batteries are
depleted
If performance changes are
detected during use- stop using the
device, remove it from arm, contact
customer service at
Fistassistdevices.com. There is no
risk to non-use during period of
device return.
A suspect device might
provide no therapy or
insufficient therapy
A suspect device might
malfunction and operate in
such a way as to cause
discomfort

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Do not autoclave, use
automated cleaning methods, or
immerse the Control Module or
Wrap in liquid as damage may
occur. If the device’s Control
Module is exposed to liquids, turn
off the unit, remove the batteries,
dry the unit thoroughly, and test the
device to evaluate for proper
operation before reapplying to the
arm for use.
A damaged device might
provide no therapy or
insufficient therapy
After periods of storage or
transport at temperature extremes
(within those specified), the device
should be allowed to return to
normal operating temperature
(within those specified) for a
duration of 2 hours (when the
ambient temperature is 20°C)
A device stored or
transported outside of its
specified operating
environmental conditions
might require up to 2 hours
to return to operating
conditions. A suspect device
might provide no therapy or
insufficient therapy
Keep the device dry and
away from heaters, steam, children
and pets.
The unit might become
damaged and provide no
therapy or insufficient
therapy
Do not attempt to service the
device while it is attached to patient
The user might increase
their risk of inadvertent
electrical contact
Rechargeable batteries of
type HR6 or any other are NOT
APPROVED FOR USE
The device might provide no
therapy or insufficient
therapy. The device might
not perform properly.
The Device must not be
exposed to water or extreme heat
A damaged device might
provide no therapy or
insufficient therapy

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•
•
•
Warning
Do not disassemble the Fist Assist
Model FA-1. Refer all servicing to
qualified service personnel at FIST
ASSIST DEVICES,LLC. No modification
of the Fist Assist Model FA-1 device is
allowed.
Precautions
Note: Precaution statements are used to highlight
information relating to special care that should be
exercised to ensure the safe and effective use of
the Fist Assist Model FA-1.
The device shall be applied to the arm gently
and fit snugly.
The device should only be used over full
clothing and never on direct skin.
The biocompatibility of the materials has not
been verified by the FDA and contact of the
cuffs/accessories to direct skin may lead to skin
irritation, skin sensitization and/or cytotoxicity.

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Limit arm movements to ensure best therapy
(sit and keep arm still during use).
Make sure the device is applied as instructed.
Safety in non-adult users has not been
established.
Do not intentionally get the device wet. If liquid
does drip onto the device, dry the Control
Module and Wrap immediately.
There are no known major adverse events
associated with Fist Assist Model FA-1.
If you suspect an allergic reaction, please stop
using the device and contact Fist Assist, LLC.

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List of Symbols and Abbreviations
Manufacturer and date of
manufacture
Refer to the Instructions for Use
Lot number
Fist Assist Model FA-1 is a Type
BF applied part (per IEC 60601-1)
Temperature limits
Relative humidity limits
Keep dry
MR Unsafe
General Warning

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Push button that toggles the
device between ON and
STANDBY (where STANDBY is
the OFF mode)
Batch code of the device
Serial number of the device
Indications for Use
The Fist Assist Model FA-1 is an arm air pressure
massager intended to temporarily relieve minor
muscle aches and/or pains, and to temporarily
increase circulation to the treated areas
Risks and Benefits
The risks and benefits of using the Fist Assist
Model FA-1 are similar to having a massage. If the
FA-1 device feels uncomfortable, you should stop
the session.

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Similar to a massage,the benefits include the
temporary relief of minor muscle aches and pains.
It also temporarily increases circulation in the area
being massaged.

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System Overview
Description
The Fist Assist Model FA-1 is a wearable, non-
sterile, battery operated, intermittent pneumatic
compression device. It is composed of two major
components that are permanently attached to one
another:
1. Control Module- contains the electronics with
miniature pump
2. Wrap- made of elastic cloth that holds the
Control Module and internal air bladder and
uses hook tape for attachment to any part of the
Wrap exterior.
The Control Module and Wrap are integral and
permanently attached. It is powered by (2) AA
batteries (not included with the device packaging).
The device is placed on the arm by looping the
strap through the elongated ring and bringing the
strap back over and toward the Control Module.
The strap is tightened so it is just snug to the arm
and not too tight. The hook fastener at the end of
the strap will then adhere to the exterior Wrap
fabric to hold the device on the arm.
The Fist Assist Model FA-1 has a single operation
mode. When powered on by depressing the single

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push button switch, it goes through pressure cycles
wherein the air bladder inflates to 60 mmHg and is
held at that pressure for 20 seconds; the air bladder
is then deflated and a minimal pressure is held for
55 seconds until the next inflation to 60 mmHg
begins again. The cycle repeats continuously until
the power is turned off using the single push button
switch. The device will turn off automatically after 1
hour of continuous use.
Components
The following section provides information on the
different components of the device.
Control Module
Wrap

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Cover Flap
(closed position)
Cover Flap
(open position)
Front Panel
Front panel view of the Control Module

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Set Up, Proper Operation, and
Use
WARNING! BEFORE OPERATING THIS
DEVICE: read all warnings at the beginning of this
information for use. If you do not understand these
operating instructions, contact Fist Assist Devices
at 1-833-434-5283 with questions.
Step 1: Unpack the Device
Remove the contents from the shipping box and
verify the following items are included as shown
below: The Wrap and Control Module.

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After unpacking the contents, inspect the shipment
for any signs of damage or loss. If any damages
are discovered, notify the carrier and the supplier,
and retain all shipping cartons for examination.
Step 2: Install the Batteries
Open the cover flap. Remove the battery door by
lightly pressing on the finger grooves and sliding
the door off. Be sure to install alkaline AA batteries
with the correct polarity using the + and – signs
found inside the Control Module. Re-attach the
battery door by sliding it back onto the Control
Module until a click is heard. Re-apply the cover
flap.

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Step 3: Check for Proper Operation
Momentarily depress (for 2 seconds) and release
the button on the front panel. Check for pump
sound / vibration and thatthe front indicator blinks
green. Turn the device off by momentarily
depressing the button again and ensure that the
pump stops and the indicator light is off.
Indicator light (flashes
green when on)
On / Off
(Power) button

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Step 4: Use of the Device
a. Apply the device to a clothed arm by sliding the
Wrap over the hand and onto the arm with the front
panel facing upward so it can be seen and
operated by the user. The device should only be
used over full clothing and never on direct skin.
b. The Control Module is to be centered over a line
that extendsfrom the thumb and up along the arm.
c. Locate the Wrap to just below the elbow or just
below the shoulder.
d. Use the hook tape on the end of the strap to
adjust the Wrap to be snug (not tight) on the arm.
e. Use the button on the front panel to start and
stop device operation as shown in Step 3, above.
f. The device will shut OFF after one (1) hour of
continuoustherapy. Press the power button to turn
the device back ON and continue therapy in
accordance with your instructions. Typical daily
usage is two (2) hours.
g. After removing the device always check for any
irritation. In case of any irritation, discontinue use
and contact Fist Assist.
The following photos are to illustrate proper
positioning of the device only.

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Control Module centered in line with thumb