Breg Flex Product Manual

FLEX
TM
PRODUCT INSERT
INFORMATION FOR PATIENTS & MEDICAL PROFESSIONALS
AW-1.01171 Rev B 0715
INDICATIONS FOR USE
Breg Flex is intended for use to assist in tracking the progress of the physical therapy
program that has been prescribed by your health care professional.
The Breg Flex System
Breg Flex Sensor Charger Attachment Strap Micro USB Cable
Mobile Device Compatibility
The Breg Flex sensor is compatible with the mobile devices listed below.
For a list of compatible operating systems (OS) , log onto breg ex.com or
contact Breg Flex Support at (888) 290-8481or (800) 321-0607 .
Apple Corporation
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iPhone 4S
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iPhone 5 / 5C / 5S
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iPhone 6 / 6plus
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iPod touch (5th Gen)
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iPad (3rd Gen) R
iPad Mini
TM
iPad Air
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Apple, iPhone, iPod, iPod touch, iPad and iPad Air are Registered Trademarks of Apple Corporation.
iPad Mini is a Trademark of Apple Corporation.
Breg, Inc.
2885 Loker Ave. East
Carlsbad, CA 92010 U.S.A.
P: 800-321-0607
760-795-5440
Scan QR Code
F: 800-329-2734
www.breg.com
2015 Breg, Inc. All Rights Reserved
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Breg Flex is a trademark of Breg, Inc.
WARNINGS
Use only as prescribed
This product is to be used only in the manner prescribed by your Health Care Practitioner or
Physical Therapist for the speci c exercise and frequency of treatment.
General safety
Keep the micro USB cable and application strap away from the neck to avoid risk of
strangulation.
No modi cation of this equipment is allowed.
Keep micro USB cable out of pathways to avoid a risk of tripping.
Choking hazard, do not place sensor in mouth.
Electrical safety
Like all electrical products, you must follow precautions to avoid electrocution, re, burns,
or other injuries. Use only the charger provided with the Breg Flex system to meet the
requirements of EN 60601-1.
Keep electrical connections dry and free of debris
The electrical connections at the power outlet and from the micro USB cable to the Breg Flex
Sensor must be kept dry. Do not handle the charger or micro USB cable with wet hands.
Always keep the charger and sensor in a place where the connections will not fall into water
(e.g., a tub, sink, etc.). If the electrical connections fall into water, do not touch any wet
part of the product. Unplug only at dry electrical connections.
Protect the micro USB cable and charger
Keep the micro USB cable and charger away from heated surfaces. Set up and use this
equipment in a low traf c location away from children and pets. Never operate this
product if it has a damaged micro USB cable, charger, or plug, which could result in
electric shock. If the micro USB cable, charger, or plug is damaged, unplug and contact
Breg Customer Care at
(888) 290-8481or (800) 321-0607
Electromagnetic interference
This Breg Flex Sensor may cause electromagnetic or other interference with other electrical
devices. Should this occur, discontinue using the Breg Flex App and contact the Breg Flex
Support Group at (888) 290-8481 for further assistance.
Avoid ammables and oxidizers
Do not use in places with ammable vapors or gasses (e.g. ammable anesthetics), high
oxygen concentrations, or other oxidizers (e.g. nitrous oxide).
Discontinue use
If signi cant pain or discomfort are present, please discontinue use immediately and
contact your health care professional.
Not intended to be used
Do not use outside of the program prescribed by your health care professional.
Do not use after your physical therapy program is complete.
Do not submerge Breg Flex Sensor
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PRODUCT SPECIFICATIONS Symbols Used on the Breg Flex Instructions for Use
Description
Symbol
This is the safety alert symbol. It is used to alert you to potential personal injury hazards.
Obey all safety messages that follow this symbol to avoid possible injury or death.
Operating Instructions
for video
Refer to instruction manual / booklet
Protected against solid foreign objects of 12.5 mm and greater.
IP22
Protected against vertically falling water drops when tilted up to 15 .
L AT E X Does not contain latex
breg ex.com
LED Indicator Light
Blink twice/1 sec
Sensor with Micro
Charging
USB Cable Connected
Sensor without Micro
USB Cable Connected
Sensor will automatically turn off after 10 minutes of inactivity
Recharge sensor prior to each treatment period
Troubleshooting Guide:
Charging:
Sensor LED should blink twice every 1 second to indicate it is charging. If the
sensor is not charging, ensure power outlet is working and power connections
are fully engaged.
Pairing:
Sensor LED should blink once every 1 second to indicate it is pairing. If the
sensor is not pairing with your device, try each of the following steps.
Ensure the Bluetooth setting on your mobile device is activated.
If sensor is not responding, try moving it around to receive a
blinking LED signal. If sensor does not respond from movement,
plug sensor into charger to ensure sensor is fully charged.
If your device Bluetooth setting is on and sensor is still not responding
restart your mobile device.
While in Use:
If sensor and your mobile device become unpaired during your therapy,
.
check your app for instructions on continuing.
If your app is not responding to either your range of motion, sets or repetitions
ensure the sensor light is in a solid state, not blinking.
If sensor LED is not coming on during movement or when charging,
please call Breg Flex support at
CLEANING, MAINTENANCE & SERVICE: HOME CLEANING PROTOCOL
Sensor:
Clean external surface with a mild cleaner applied to a clean cloth.
Do not spray cleaner into micro USB port.
Do not submerge sensor unit in water or cleaning solution.
Use a small comb or toothpick to remove any ber build up in hook fastener.
The Breg Flex Sensor contains no user-serviceable parts.
Contact Breg Customer Care for service or replacements.
(888) 290-8481or (800) 321-0607
Symbol
WEEE- Waste of Electronic and Electrical Equipment
Type BF, applied part
Class II Equipment
Product #: Weight
100461-000 0.5 oz (.015 kg)
FCC ID:
2AE82100461-000 Flex Sensor Sensor Only
Micro USB Cable / Charger:
Blink once/1 sec Steady Glow
Fully charged
Application Strap:
Pairing with Bluetooth Sensor paired
Federal Commications Commission (FCC) Statement (USA):
This device complies with FCC 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 recieved, including interference that may
cause undesired operation
Note: Breg is not responsible for any radio or TV interference caused by unauthorized modi cations to this
equipment. Changes or modi cations not approved by Breg , Inc. could void the user's authority to operate
the equipment. This device meets the FCC requirements for RF exposure in public or uncontrolled
environments.
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 guarentee 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 off and on, the user is encouraged to try to correct the
interference by one or more of the following measures:
-Reorient or relocate the recieving antenna
-Increase the seperation between the equipment and the reciever
-Connect the equipment into an outlet on a circuit different from that to which the receiver is connected
-Consult the Breg Customer Service Representative or an experienced radio/TV technician for help
.
(888) 290-8481or (800) 321-0607
DISPOSAL
Dispose of product according to local regulations.
WARRANTY
Breg, Inc. warrants that this product is free from defects in workmanship, materials, and
tness for use for 180 days from initial purchase under normal use for which it was
intended and under direct supervision of a licensed healthcare practitioner.
Breg, Inc.'s obligation under this warranty is limited to the replacement or repair of any
defective part or parts of this product. All expressed or implied warranties, including the
warranty of merchantability and tness for a particular purpose, are limited to the actual
warranty period set forth above. No other warranty, express or implied, is given and no
Physical and Electrical Speci cations
Description
Manufacturer: Qualtek USA
Rated Input: 100-240V~, 50-60Hz
Transport & Storage:
Operating:
Recomended Operating Range Expected Service Life
Standards Compliance:
Recomended operating range of 6 months from date of
Electrical Classifications:
Flex Sensor 0'-10' (0m-3.05m) rst use.
Clean external surfaces with a mild cleaner applied to a clean cloth.
Inspect micro USB cable before use to ensure insulation is unbroken.
Do not spray cleaner into USB port.
Do not submerge charger or micro USB cable in water or cleaning solution.
Hand wash strap in luke warm water with a mild detergent.
Lay at to air dry only.
Use a small comb or toothpick to remove any ber build up in hook fastener.
af rmation of or by seller, by words or action, will constitute a warranty.
Unit Rated: 5Vdc, 1000mA
Power supply is speci ed as part of ME Equipment
Model: QFAW-05-05
Output: 5Vdc, max. 1.0A
Environmental Requirements:
–25°C (–13°F) no humidity control to 70°C (158°F ) up to 93%RH
5°C to 40°C (41°F to 100°F )15-93%RH - 700 hPa to 1060 hPa
Designed to conform to applicable requirements of: IEC60601-1, 3rd Edition
Class II, Continuous Operation - Not suitable with flammable anesthetics