Fist Assist FA-1 Instructions For Use Manual

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Instructions for Use

Fist Assist Model FA-1

www.fistassistdevices.com

www.fistassistusa.com

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Page 1 Instructions for Use Fist Assist Model FA-1 www.fistassistdevices.com www.fistassistusa.com...
Page 2: Table Of Contents
Contents ......Warnings Precautions List of Symbols and Abbreviations Indications for Use Risks and Benefits System Overview Description Components Set Up, Proper Operation, and Use Step 1: Unpack the Device Step 2: Install the Batteries Step 3: Check for Proper Operation Step 4: Use of the Device Positioning the Device Applied just below the elbow...
Page 3 Classification and Standards Manufacturer’s Declaration Table General Notes Guidance & Manufacturer’s Declaration- Electromagnetic Immunity Recommended Separation Distances Troubleshooting Contacting Fist Assist Devices, LLC Manufacturer Contact and Ordering Information 35 Technical Support Disposal Warranty Return Goods Policy Limitations of Liability...
Page 4: Warnings
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.
Page 5 Fist Assist Devices, LLC recommends that all users who will Improper use of the device be operating the Fist Assist Model might provide no therapy or FA-1, review this Instructions For insufficient therapy Use (IFU) prior to use. If there are...
Page 6 The device might of the Fist Assist Model FA-1 malfunction and operate in such a way as to cause discomfort The device might malfunction provide no Portable RF communications therapy or insufficient equipment (including peripherals therapy...
Page 7 Do not autoclave, use automated cleaning methods, or immerse the Control Module or A damaged device might Wrap in liquid as damage may provide no therapy or occur. If the device’s Control insufficient therapy Module is exposed to liquids, turn off the unit, remove the batteries, dry the unit thoroughly, and test the device to evaluate for proper...
Page 8: Precautions
Model FA-1. Refer all servicing to qualified service personnel at F , LLC. No modification SSIST EVICES 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.
Page 9 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.
Page 10: List Of Symbols And Abbreviations
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...
Page 11: Indications For Use
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...
Page 12 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.
Page 13: System Overview
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.
Page 14: Components
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.
Page 15 Cover Flap (closed position) Cover Flap (open position) Front Panel Front panel view of the Control Module...
Page 16: 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.
Page 17: Step 2: Install The Batteries
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.
Page 18: Step 3: Check For Proper Operation
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 that the 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.
Page 19: Step 4: Use Of The Device
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.
Page 20 Control Module centered in line with thumb...
Page 21: Positioning The Device
Positioning the Device Applied just below the elbow Note alignment of the Control Module with the thumb Applied just below the shoulder Note alignment of the Control Module with the thumb Thumb...
Page 22: Indicator Led
Indicator LED The indicator LED flashes approximately once every 2 seconds to indicate that the device is “ON”. GREEN flashing LED indicates that the battery has adequate charge remaining for therapy. ORANGE flashing LED indicates the battery charge is low and batteries require replacement soon. Audio Indicator An audio indicator within the Control Module has two functions:...
Page 23: Storage And Cleaning
Control Module and damage its internal components. Cleaning The Fist Assist Model FA-1 is supplied non- sterile. It is suggested to clean the device once per week. Use only a cloth, dampened with water (no soaps or detergents) to wipe the outside surfaces of the Control Module and Wrap.
Page 24 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.
Page 25: Technical Specifications
Technical Specifications List of Technical Specifications The following table lists the technical specifications for the Fist Assist Model FA-1 device: Item Specification Dimensions of 9.9 CM x 5.6 CM x 2.4 CM Control Module (Length x Width x Depth) Weight including Wrap 160 g (0.35 lbs.)
Page 26 Item Specification -25°C to +5°C, and +5°C to +35°C at a relative humidity up to 90% non- Transport / condensing Storage >35°C to 70°C at a water vapor Environmental pressure up to 50hPa after the Limits device has been removed from its packaging and subsequently between uses Rated Applied...
Page 27: Battery Service Life
Item Specification Mode of Continuous Operation Not suitable for use in the presence Fire Hazard of flammable anesthetics mixture with air, oxygen, or nitrous oxide. The device will operate for Battery Life approximately 30 hours on a fresh set of batteries The device will operate for Low battery approximately 10 hours after the low...
Page 28: Operation Modes
Operation Modes The Fist Assist Model FA-1 has a single operation mode. When powered on it goes through a pressure cycle wherein the air bladder inflates to 60 mmHg and is held at that pressure for 20 seconds. The air bladder is then deflated to 10 mmHg or less and that pressure is held for 55 seconds.
Page 29 Assist Model FA-1. Guidance & Manufacturer’s Declaration -Electromagnetic Emissions The Fist Assist Model FA-1 device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment.
Page 30: Guidance & Manufacturer's Declaration-Electromagnetic Immunity
Guidance & Manufacturer’s Declaration- Electromagnetic Immunity During immunity testing, the Fist Assist Model FA-1 maintained its ability to function within specification. The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment.
Page 31: Recommended Separation Distances
Recommended Separation Distances Between portable and mobile RF communications equipment and the Fist Assist Model FA-1 The Fist Assist Model FA-1 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. Home network devices, mobile phones, cordless...
Page 32 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
Page 33: Troubleshooting
Troubleshooting Problem Solution What if the The device is sensing a pressure device double issue and must be reset. Replace beeps? with new batteries or reset by removing the batteries from the battery compart, then reinsert in the proper orientation. How do I turn it Hold the start button for 2 seconds then release.
Page 34 If it gets Please contact your authorized damaged or is dealer from which you not working, purchased the device for how do I return refund or replacement.
Page 35: Contacting Fist Assist Devices, Llc
Assist Devices, LLC sales or customer service representative, or an authorized dealer. For assistance in setting up, using, or maintaining the Fist Assist Model FA-1 or to report unexpected operation or events, please contact Fist Assist at the contact information is shown below.
Page 36: Technical Support
Technical Support If the Fist Assist device fails to perform as specified, replace the batteries with fresh AA alkaline types while ensuring proper polarity per the label in the battery compartment and proceed to Step 2 Install the Batteries. If the problem is not resolved and the cause cannot be determined, do not use or attempt to repair it.
Page 37 AGENTS, OR LICENSORS WARRANTS THAT THE FIST ASSIST DEVICES WILL BE DEFECT FREE, NOR DO THEY WARRANT THAT CERTAIN RESULTS MAY BE OBTAINED BY THE USE OF ANY FIST ASSIST DEVICE IN CONNECTION WITH THE DELIVERY OF PROFESSIONAL MEDICAL SERVICES BECAUSE,...
Page 38: Return Goods Policy
Determination of a product defect or mislabeling will be made by Fist Assist Devices, LLC, and the determination will be final. Products will not be accepted for replacement if they have been in...
Page 39: Limitations Of Liability
Limitations of Liability Fist Assist Devices, LLC assumes no liability if the device is misused, and Fist Assist Devices, LLC neither assumes, nor authorizes any other person to assume for it, any other or additional LIABILITY or RESPONSIBILITY in connection with the sale or use of any Fist Assist Devices, LLC device.
Page 40 SALE AND USE OF ANY FIST ASSIST DEVICES, LLC DEVICE, AND FIST ASSIST DEVICES, LLC, WOULD NOT HAVE SOLD ANY DEVICE WITHOUT THEIR INCLUSION. NO ACTION, REGARDLESS OF FORM, ARISING OUT OF THE PURCHASE OR USE OF ANY FIST ASSIST...