Breg Inc. 100461-000 Manuel D’Utilisation

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bregflex.com

Designed to conform to applicable requirements of: IEC60601-1, 3rd Edition

Class II, Continuous Operation - Not suitable with flammable anesthetics

Unit Rated: 5Vdc, 1000mA

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.

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 

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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. 

          

 

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.

           

Do not use in places with flammable vapors or gasses (e.g. flammable anesthetics), high 
oxygen concentrations, or other oxidizers (e.g. nitrous oxide).

            

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.

          

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

.

The Breg Flex Sensor contains no user-serviceable parts. 

Contact Breg Customer Care for service or replacements.

(888) 290-8481or (800) 321-0607

LED Indicator Light

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.

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:

           

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.

      

      

           

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.

           

If significant pain or discomfort are present, please discontinue use immediately and 
contact your health care professional.

           

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

    

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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.

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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

.

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Breg Flex Sensor

Charger

Attachment Strap

Micro USB Cable

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

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  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

AW-1.01171 Rev B 0715