DJO SRB iQ Lightweight Knee Sleeve Instructions
BEFORE USING THE DEVICE, PLEASE READ THE FOLLOWING INSTRUCTIONS COMPLETELY AND CAREFULLY. CORRECT APPLICATION IS VITAL TO THE PROPER FUNCTIONING OF THE DEVICE.
INTENDED USER PROFILE
The intended user should be a licensed medical professional, the patient, the patient’s caretaker, or a family member providing assistance. The user should be able to read, understand and be physically able to perform and follow the directions, warnings and cautions provided in the information for use. This device is not intended for use by children.
INTENDED USE/INDICATIONS
The SRB iQ is intended to provide knee support during the rehabilitative process. The Motion iQ platform together with the SRB iQ is intended to be used to measure and evaluate activity and knee joint range of motion during rehabilitation and exercise in post-operative phases of reconstructive knee surgery.
CONTRAINDICATIONS
None.
WARNINGS AND CAUTIONS
If you experience any pain, swelling, sensation changes, or any unusual reactions while using this product, consult your medical professional immediately.
Do not wear brace while swimming, in the shower or bath.
Warning: Equipment contains CR2032 lithium coin cell battery. There is danger of explosion if lithium ion batteries are incorrectly replaced.
SYMBOLS
WARNING! Read and understand all warnings and Instructions for Use before using this device.
Temperature range
Atmospheric pressure range
Indication for protection against water and particular matter.
Manufacturer
Non-ionizing electromagnetic radiation
Humidity Range
Prescription only (USA).
ENVIRONMENTAL CONDITIONS
| Operating Conditions | Temperatures | +41°F (5°C) TO +104°F (40°C) |
| Relative Humidity | 15% to 90% non-condensing | |
| Atmospheric Pressure | 10.2 psi (700 hPa) to 15.4 psi (1060 hPa) | |
| Altitude | Maximum of 9,842 Ft (3000 m) | |
| Transport and Storage Conditions | Temperatures | -13°F (-25°C ) without relative humidity control, up to 158°F (70°C) |
| Relative Humidity | 15% – 90% non-condensing | |
| Atmospheric Pressure | 7.3 psi (500 hPa) to 15.4 psi (1060 hPa) |
When operating after transporting or storage in elevated or low temperature conditions, please keep sensor at ambient temperature for 15 min. prior to operation.
Motion iQ system consists of: 1 regular hinge, 1 hinge with sensor, 1 software app for smart device.
APPLICATION SET UP AND PAIRING
- Download Motion iQTM App from the App store.
- Ensure Bluetooth is enabled on your phone or tablet Settings
- For iPhone: Settings > Bluetooth > On
- For Android: Settings > Connections. Bluetooth > On
- Follow the link in the welcome email from your clinician. This will launch the Motion iQ application and start your account setup. (Note: If you have not yet received a welcome email, please contact your physician)
- Follow the instruction in the application to complete your account setup.
- Follow the instructions in the application to pair with your mobile phone or tablet.
- When prompted by the app to choose a brace to pair, select DonJoy SRB iQ.
- On the thicker hinge, use a small object such as a pen or paper clip to press the button until the blue LED light blinks (see image below).
- Click “Go” when prompted in the app on your mobile phone or tablet
- Screen will show “Congratulations” when successfully connected.
Note: This step only needs to occur one time. Brace will pair automatically while wearing the brace and standing in full extension.
If a previous smart device was connected to the application:
- Open application
- Go to smart devices in the app
- Select the device previously used, and click “unpair”
- Repeat pairing instructions for new device as above
BRACE APPLICATION INFORMATION
- Sit in a chair and have the knee bent in a 45 degree angle.
- Slide the sleeve up the leg over the knee. Line up the hinges with the midline of the knee on both sides.
If you are having any medical issues or need an urgent response, please call your doctor’s office directly.
If assistance is needed with the brace or setting up or using the App, please call or email:
Phone: (844) 279-0200
Email: [email protected]
Visit: DJOglobal.com
CLEANING INSTRUCTIONS
Carefully remove the hinges and uprights from the brace by
1) Lift up on the velcro underneath the hinges to separate from the sleeve and 2) Slide the uprights from the silicone supports.
Hand wash sleeve in water (30°C) with mild detergent. Rinse thoroughly. AIR DRY only, do not heat dry.
Do not wash the hinge component containing the electronic sensor.
After cleaning and drying, carefully insert the uprights into the silicone supports until fully seated. Then reattach the velcro on the hinge and sleeve.
MATERIAL CONTENT
Polyester 20%, Bamboo 20%, Silicon 20%, Nylon 15%, Spandex 10%, Steel 10%, Aluminum 5%.
BATTERY REPLACEMENT
- Using a Phillips head screw driver, remove the hinge cover by unscrewing the two screws.
- Using a fingernail or small object such as a ball point pen, push the gold battery clip out then remove the battery.
- Place the new battery into the slot towards the gold clip then push the opposite side down until the battery clicks into place.
- Carefully slide the hinge cover back onto the brace and secure by replacing the screws.
KEEP OUT OF REACH OF CHILDREN. Swallowing may lead to serious injury or death in as little as 2 hours due to chemical burns and potential perforation of the esophagus. Immediately see doctor, have doctor phone (800)498-8666.
FCC AND ICC STATEMENTS
FCC Statements
Warning: changes or modifications to this device not expressly approved by (DJO LLC) could void the user’s authority to operate the equipment.
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 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 receiving antenna.
- Increase the separation between the equipment and receiver.
- Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.
- Consult the dealer or an experienced radio/TV technician for help.
This equipment complies with radiation exposure limits set forth for an uncontrolled environment. This equipment is in direct contact with the body of the user under normal operating conditions. This transmitter must not be co-located or operating in conjunction with any other antenna or transmitter.
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.
IC Statements
This device complies with Industry Canada licence-exempt RSS standard(s). Operation is subject to the following two conditions: (1) this device may not cause interference, and (2) this device must accept any interference, including interference that may cause undesired operation of the device.
ELECTROMAGNETIC COMPATIBILITY (EMC)
The SRB iQ sensor is intended for use in the electromagnetic environment specified below. The customer or user of the SRB iQ sensor should assure that it is used in such an environment.
| Guidance and Manufacturer’s Declaration – Electromagnetic Emissions | ||
| Emissions Tests | Compliance | Electromagnetic Environment Guidance |
| RF Emissions CISPR 11 | Group 1 | The SRB iQ sensor is equipment where there is intentionally generated, or used, conductively coupled Radio Frequency (RF) energy that is necessary for the internal functioning of the equipment |
| RF Emissions CISPR 11 | Class B | The SRB iQ sensor is suitable for use in all establishments, including domestic establishments and those directly connected to public low voltage power supply network that supplies buildings used for domestic purposes. |
| Harmonic Emissions IEC 61000-3-2 | N/A. Battery Powered. | N/A |
| Voltage Fluctuations/ emission oscillations IEC 61000-3-3 | N/A. Battery Powered. | N/A |
| Guidance and Manufacturer’s Declaration – Electromagnetic Immunity | |||
| Immunity Test | IEC 60601 Test Level | Compliance Level | Electromagnetic Environment Guidance |
| Electrostatic Discharge (ESD) |
±6 kV contact |
±8 kV contact | Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. |
| Electrical Fast Transient/ Burst IEC 61000-4-4 | ±2 kV for power supply lines ±1 kV for input/ output lines | N/A. Battery Powered. | Main power quality should be that of a typical commercial or hospital environment. |
| Surge | ±1 kV differential mode ±2 kV common mode | N/A. Battery Powered. | Main power quality should be that of a typical commercial or hospital environment. |
| Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11 | <5% U (>95% dip in TU) for 0.5 cycle 40% U (60% dip in TU) for 5 cycles 70% U (30% dip in TU) for 25 cycles <5% U (>95% dip in TU) for 5 sec | N/A. Battery Powered. | Main power quality should be that of a typical commercial or hospital environment. |
| Power Frequency (50/60Hz) | 3 A/m | 30 A/m | Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. |
| Guidance and Manufacturer’s Declaration – Electromagnetic Immunity | |||
| Portable and mobile RF communications equipment should be used no closer to any part of the SRB iQ sensor, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. | |||
| Immunity Test | IEC 60601 Test Level | Compliance Level | Recommended Separation Distance |
| Conducted RF IEC 61000-4-6 | 3 Vrms 150 kHz to 80 MHz | 3V | 1.2√P |
| Radiated RF IEC 61000-4-3 | 3V/m 80 MHz to 2.5 GHz | 10 V/m | 0.35√P 80 MHZ TO 800 MHZ 0.7√P 800 MHZ TO 2.5 GHZ |
| Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site surveya, should be less than the compliance level in each frequency rangeb. Interference may occur in the vicinity of equipment marked with the following symbol: | |||
| NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people | |||
Field strengths from fixed transmitters, such as base stations for radio
(cellular/ cordless) telephones and land mobile radios, amateur radio,
AM and FM radio broadcast and TV broadcast cannot be predicted
theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the SRB iQ sensor is used exceeds the applicable RF compliance level above, the SRB iQ sensor should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the SRB iQ sensor .
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
TECHNICAL SPECIFICATIONS
| Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the SRB iQ sensor | |||
| The SRB iQ sensor is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the SRB iQ sensor can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the SRB iQ sensor as recommended below, according to the maximum output power of the communications equipment. | |||
| Rated maximum output power of transmitter (Watts) | Separation distance according to frequency of transmitter (Meters) | ||
| 150 KHz to 80 MHz d = 1.2 √P | 80 MHz to 800 MHz d = 0.35 √P | 800 MHz to 2.5 GHz d = 0.7 √P | |
| 0.01 | 0.12 | 0.03 | 0.07 |
| 0.1 | 0.38 | 0.11 | 0.22 |
| 1 | 1.2 | 0.35 | 0.7 |
| 10 | 3.8 | 1.1 | 2.2 |
| 100 | 12 | 3.5 | 7 |
| 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. NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. | |||
WARRANTY
DJO, LLC will repair or replace all or part of the unit and its accessories for material or workmanship defects for a period of six months from the date of sale. To the extent the terms of this warranty are inconsistent with local regulations. The provisions of such local regulations will apply.
DISPOSAL
Sensor is electronic equipment and may include substances that can damage the environment. Do not dispose of the device in municipal waste. Do not puncture. Do not dispose in fire or incinerate. Dispose of the unit according to national, state, and local regulations.
Rx ONLY.
INTENDED FOR SINGLE PATIENT USE.
NOT MADE WITH NATURAL RUBBER LATEX.
NOTICE: WHILE EVERY EFFORT HAS BEEN MADE IN STATEOF-THE-ART TECHNIQUES TO OBTAIN THE MAXIMUM COMPATIBILITY OF FUNCTION, STRENGTH, DURABILITY AND COMFORT, THERE IS NO GUARANTEE THAT INJURY WILL BE PREVENTED THROUGH THE USE OF THIS PRODUCT. THIS DEVICE IS NOT INTENDED TO PREVENT INJURY, BUT AS AN ADJUNCT TO POST-OPERATIVE THERAPY. USE CAUTION AND FOLLOW YOUR DOCTOR’S ADVICE.
DJO, LLC
1430 Decision Street
Vista, CA 92081-8553 • USA
T +1.800.321.9549
T +1.800.336.6569
F +1.800.936.6569
DJOglobal.com
©2021 DJO, LLC. All rights reserved.
14-4013 REV B
2021/02/16
