background image

EN

13

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 

survey

a

, should be less than the 

compliance level in each 

frequency range

b

.

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

Содержание Donjoy SRB iQ

Страница 1: ...SRB iQ Instructions For Use ...

Страница 2: ......

Страница 3: ...INGS AND CAUTIONS 2 SYMBOLS 3 ENVIRONMENTAL CONDITIONS 3 APPLICATION SET UP AND PAIRING 4 BRACE APPLICATION INFORMATION 5 CLEANING INSTRUCTIONS 6 MATERIAL CONTENT 6 BATTERY REPLACEMENT 7 FCC AND ICC STATEMENTS 9 ELECTROMAGNETIC COMPATIBILITY EMC 11 TECHNICAL SPECIFICATIONS 15 WARRANTY 16 DISPOSAL 16 ...

Страница 4: ...dren 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 ...

Страница 5: ...re 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 SYMBOLS WARNING Read and understand all warnings and Instructions for Use before using this device Tempe...

Страница 6: ...ician 4 Follow the instruction in the application to complete your account setup 5 Follow the instructions in the application to pair with your mobile phone or tablet a When prompted by the app to choose a brace to pair select DonJoy SRB iQ b 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 c Click Go when promp...

Страница 7: ...e app 3 Select the device previously used and click unpair 4 Repeat pairing instructions for new device as above BRACE APPLICATION INFORMATION 1 Sit in a chair and have the knee bent in a 45 degree angle 2 Slide the sleeve up the leg over the knee Line up the hinges with the midline of the knee on both sides 2 3 ...

Страница 8: ...he 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 seate...

Страница 9: ...sing a Phillips head screw driver remove the hinge cover by unscrewing the two screws 2 Using a fingernail or small object such as a ball point pen push the gold battery clip out then remove the battery 4A CR 2032 5A CR 2032 4B 5B ...

Страница 10: ...s and potential perforation of the esophagus Immediately see doctor have doctor phone 800 498 8666 3 Place the new battery into the slot towards the gold clip then push the opposite side down until the battery clicks into place 4 Carefully slide the hinge cover back onto the brace and secure by replacing the screws CR 2032 6 7 ...

Страница 11: ...ion 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 exper...

Страница 12: ...s de licence L exploitation est autorisée aux deux conditions suivantes 1 l appareil ne doit pas produire de brouillage et 2 l utilisateur de l appareil doit accepter tout brouillage radioélectrique subi même si le brouillage est susceptible d en compromettre le fonctionnement Cet équipement est conforme aux limites d exposition aux radiations dans un environnement non contrôlé Cet équipement est ...

Страница 13: ...oup 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 supp...

Страница 14: ...at of a typical commercial or hospital environment Surge IEC 61000 4 5 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 c...

Страница 15: ...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 Interfe...

Страница 16: ... 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 b ...

Страница 17: ...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 t...

Страница 18: ...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 STATE OF THE ART TECHNIQUES TO OBTAIN THE MAXIMUM COMPATIBILITY OF FUNCTION STRENGTH DURABILITY AND COMFORT THERE ...

Страница 19: ......

Страница 20: ...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 ...

Отзывы: