Scan QR Code
for video
bregflex.com
Physical and Electrical Specifications
Designed to conform to applicable requirements of: IEC60601-1, 3rd Edition
Class II, Continuous Operation - Not suitable with flammable anesthetics
Unit Rated: 5Vdc, 1000mA
L AT E X
Expected Service Life
Recomended operating range of
Flex Sensor 0’-10’ (0m-3.05m)
0.5 oz (.015 kg)
Sensor Only
100461-000
Flex Sensor
6 months from date of
first use.
PRODUCT SPECIFICATIONS
Symbols Used on the Breg Flex Instructions for Use
Symbol
Description
Operating Instructions
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.
Refer to instruction manual / booklet
IP22
Protected against solid foreign objects of 12.5 mm and greater.
Protected against vertically falling water drops when tilted up to 15 .
Does not contain latex
Transport & Storage:
Operating:
Standards Compliance:
Electrical Classifications:
–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
Manufacturer: Qualtek USA
Model: QFAW-05-05
Rated Input: 100-240V~, 50-60Hz
Output: 5Vdc, max. 1.0A
Power supply is specified as part of ME Equipment
Class II Equipment
Type BF, applied part
WEEE- Waste of Electronic and Electrical Equipment
Symbol
Description
Product #:
Weight
Recomended Operating Range
Environmental Requirements:
2AE82100461-000
FCC ID:
iPhone 4S
iPhone 5 / 5C / 5S
iPhone 6 / 6plus
iPod touch (5th Gen)
iPad (3rd Gen)
iPad Mini
iPad Air
R
Mobile Device Compatibility
General safety
Keep the micro USB cable and application strap away from the neck to avoid risk of
strangulation.
No modification 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.
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 specific exercise and frequency of treatment.
DISPOSAL
Dispose of product according to local regulations.
WARRANTY
Breg, Inc. warrants that this product is free from defects in workmanship, materials, and
fitness 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.
INFORMATION FOR PATIENTS & MEDICAL PROFESSIONALS
Avoid flammables and oxidizers
Do not use in places with flammable vapors or gasses (e.g. flammable anesthetics), high
oxygen concentrations, or other oxidizers (e.g. nitrous oxide).
Electrical safety
Like all electrical products, you must follow precautions to avoid electrocution, fire, burns,
or other injuries. Use only the charger provided with the Breg Flex system to meet the
requirements of EN 60601-1.
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 traffic 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
.
CLEANING, MAINTENANCE & SERVICE: HOME CLEANING PROTOCOL
The Breg Flex Sensor contains no user-serviceable parts.
Contact Breg Customer Care for service or replacements.
(888) 290-8481or (800) 321-0607
PRODUCT INSERT
INDICATIONS FOR USE
WARNINGS
LED Indicator Light
Do not submerge Breg Flex Sensor
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 fitness for a particular purpose, are limited to the actual
warranty period set forth above. No other warranty, express or implied, is given and no
affirmation of or by seller, by words or action, will constitute a warranty.
Blink twice/1 sec
Blink once/1 sec
Steady Glow
Sensor with Micro
USB Cable Connected
Sensor without Micro
USB Cable Connected
Pairing with Bluetooth
Fully charged
Charging
Sensor paired
Sensor will automatically turn off after 10 minutes of inactivity
Recharge sensor prior to each treatment period
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.
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.
Troubleshooting Guide:
Charging:
Pairing:
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
(888) 290-8481or (800) 321-0607
.
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:
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.
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.
Sensor:
Micro USB Cable / Charger:
Application Strap:
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 fiber build up in hook fastener.
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 flat to air dry only.
Use a small comb or toothpick to remove any fiber build up in hook fastener.
Discontinue use
If significant 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.
Apple Corporation
R
Apple, iPhone, iPod, iPod touch, iPad and iPad Air are Registered Trademarks of Apple Corporation.
iPad Mini is a Trademark of Apple Corporation.
R
R
The Breg Flex sensor is compatible with the mobile devices listed below.
For a list of compatible operating systems (OS) , log onto bregflex.com or
contact Breg Flex Support at
(888) 290-8481or (800) 321-0607
.
TM
R
R
R
R
R
The Breg Flex System
Breg Flex Sensor
Charger
Attachment Strap
Micro USB Cable
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 modifications to this
equipment. Changes or modifications 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
C
2015 Breg, Inc. All Rights Reserved
Breg Flex is a trademark of Breg, Inc.
Breg, Inc.
2885 Loker Ave. East
Carlsbad, CA 92010 U.S.A.
P: 800-321-0607
760-795-5440
F: 800-329-2734
www.breg.com
FLEX
TM
AW-1.01171 Rev B 0715
