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Pain Care Labs Buzzy Mini User Manual

Pain Care Labs Buzzy Mini
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109
Developed by a physician, Buzzy® is a
reusable device for minor aches and pains.
Buzzy
®
Healthcare is for use in a professional healthcare facility
by trained operator. Reusable pain relief product intended for
multiple users. Thoroughly clean and disinfect Buzzy
®
and its
accessories between patients following your facility’s infection
control protocol for reprocessing non-critical equipment.
BuzzyHelps.com
For Buzzy
®
Mini Healthcare (Striped, Black, and LadyBuzz)
and Buzzy
®
XL Healthcare (Striped, Black, and LadyBuzz)
BKHM1, BKHM2, BKHM3, BTH1, BTH2, BTH3
IFU-001 Rev 00 Buzzy Healthcare Instructions for Use
09.17.2020
Indications For Use:
Controls pain associated with injections (venipuncture, IV
starts, cosmetic procedures) and the temporary relief of
minor injuries (muscle or tendon aches, splinters and bee
stings). Also intended to treat myofascial pain caused by
trigger points, restricted motion and muscle tension.
Warnings:
For intended use only • Direct or prolonged application of ice
could vasoconstrict or alter lab values.
Contraindications:
Do not use in the presence of unexplained calf pain. Consult
a physician. • This device should not be used over swollen or
inamed areas or skin eruptions. Do not place directly on a
thermal burn • Do not use ice pack with underlying sensitivities
to ice or cold (e.g. Sickle Cell Disease, Reynaud’s Disease).
Cautions:
Store wings in a cool, dry place. • Wings must be frozen solid
for best eect. Do not use dry ice to freeze wings unless
supervised by a healthcare professional • Do not puncture ice
pack chambers. • Discard if leaking. • Do not ingest gel. • Keep
out of reach of children or pets. • Do not use with neuropathy,
CRPS, or sensitivities to ice.
Model Differences:
Buzzy
®
Mini: Comes with Buzzy
®
vibration unit with button
switch and energy saving automatic 3-minute shut-o, four
reusable ice wings and 1 Comfort Strap, and instructions. Press
and hold button rmly until vibration activates.
Buzzy
®
XL: Comes with Buzzy
®
vibration unit with toggle switch,
four reusable ice wings and 2 Comfort Straps, and instructions.
Keep the tape on the switch during transport to avoid accidental
activation. Activate with the on/o toggle switch.
Cleaning:
Buzzy
®
is a reusable medical device that should be thoroughly
cleaned and reprocessed following your facility’s infection
control protocol for non-critical equipment. All accessories
must be cleaned and disinfected with your facility’s disinfecting
wipes or method used to reprocess non-critical equipment
such as stethoscopes or patient monitors. Do not autoclave.
Do not immerse in liquid.
Batteries:
Unscrew the back using a Phillips-head screwdriver to remove
back panel. Buzzy
®
is powered by 2 alkaline AAA batteries. Remove
batteries if Buzzy
®
is not being used for extended period of time.
Disposal:
Please contact your local authorities to determine the proper
method of disposal of potentially biohazardous parts and
accessories.
DO NOT SERVICE WHILE IN USE
US Patented British Patent No. 2455695
RM-1910, 1248-064-5002-00, 1248-064-5001-00
Troubleshooting:
With proper care, your Buzzy should last for at least 1
year. With heavy use or extreme temperature uctuations,
batteries may need to be replaced more frequently. If device
stops working, replace batteries. Press switch rmly for 1/2
second to activate or turn o.
How To Order/Additional Information:
Please visit our website buzzyhelps.com for a complete
list of FAQ’s, other pain management tips, how-to videos,
accessories, replacement parts, and more!
Guarantee:
Previous medical history and intrinsic physiologic dierences
may make Buzzy
®
less eective for some people. If not
completely satised, return within 30 days to place of
purchase for a full refund, or contact us at the address below.
MMJ Labs, LLC dba Pain Care Labs
322 Sutherland Place • Atlanta, GA 30307, U.S.A.
buzzyhelps.com • info@paincarelabs.com
877.805.2899
Authorized European Representative
MPC International S.A.
26, Boulevard Royal • L-2449 Luxembourg
Tel. +352 22 99 99 5546 | www.mpc.cc
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Indications For Use .......................................... 1
Warnings, Contraindications, Cautions ......... 1
Model Dierences ............................................ 2
Directions For Use ........................................... 3
Ice Wings ................................................... 3, 4
For Injections ................................................ 5
Buzzy
®
Placement ............................................ 5
Finger Sticks, Splinters ................................ 7
Stomach Injections ...................................... 7
Burning, Itching ............................................ 7
IVs & Phlebotomy, For children .................. 8
Cleaning, Changing Batteries, Disposal ......... 9
Troubleshooting, Ordering, Guarantee ....... 10
Environmental conditions:
Transport and storage
between uses: -25 to 70 °C.
0-95% RH. 700-1060 hPa
Operating conditions:
5-40 °C. 15-95% RH
700-1060 hPa. 2000m altitude
ON
OFF
1. This device complies with Part 15 of the FCC Rules. Operation is subject to the following two
conditions: (1) this device may not cause harmful interference, and (2) this device must accept any
interference received, including interference that may cause undesired operation.
2. “Please note that changes or modications of this product is not expressly approved by the party
responsible for compliance could void the user’s authority to operate the equipment.”
3. 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.
However, there is no guarantee that interference will not occur in a particular installation.
If this equipment does cause harmful interference to radio or television reception, which can be
determined by turning the equipment o and on, the user is encouraged to try to correct the
interference by one or more of the following measures:
• Reorient or relocate the receiving antenna. • Increase the separation between the equipment and
receiver. Connect the equipment into an outlet on a circuit dierent from that to which the receiver
is connected. • Consult the dealer or an experienced radio/TV technician for help.
4. This device complies with Part 15 of the FCC Rules. Operation is subject to the following
two conditions: (1) this device may not cause harmful interference, and (2) this device
must accept any interference received, including interference that may cause undesired
operation. Pain Care Labs, 195 Arizona Ave • LW08 NE Atlanta GA 30307 • 877-805-2899
(Pain Care Labs Responsible Party in USA.)
Type BF Applied Part
DRAFT
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Pain Care Labs Buzzy Mini Specifications

General IconGeneral
CategoryPersonal Care Products
UsePain Relief
Battery TypeAAA batteries
FeaturesVibration
Color OptionsBlue
Warranty1 year

Summary

Indications For Use

Warnings, Contraindications, Cautions

Safety information including warnings, contraindications, and cautions for using the Buzzy device.

Model Differences

Details on the differences between Buzzy Mini and Buzzy XL models, including features and operation.

Directions For Use

Buzzy Placement

Guidance on optimal placement of the Buzzy device on the body for various procedures and pain relief.

For Injections

Specific instructions for using Buzzy during injections to manage pain at the injection site.

For Finger Sticks and Splinter Removal

Instructions for using Buzzy to reduce pain during finger sticks or splinter removal.

For IVs or Phlebotomy

Guidance on using Buzzy for IV insertion or phlebotomy procedures, avoiding direct application on the access site.

Maintenance and Disposal

Cleaning and Battery Replacement

Instructions for cleaning the device and replacing the AAA batteries for continued use.

Disposal

Guidelines for the proper disposal of the Buzzy device and its components.

Troubleshooting and Support

Troubleshooting

Common issues and solutions for operating the Buzzy device.

Ordering and Guarantee

Information on how to order the product and details about the guarantee policy.