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Cala Health Trio, Руководство для пациента

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33

LBL-5117 Rev C AUG 2019

10.0

ELECTROMAGNETIC COMPATIBILITY  

DECLARATION

Cala Trio Stimulator claims compliance for electromagnetic 
compatibility in conjunction with Cala Trio Base Station.

(1) This device may not cause harmful interference, and (2) 
this device must accept any interference received, including 
interference that may cause undesired operation.

Do not tamper with, modify, or attempt to perform 
maintenance or servicing on Cala Trio.

GENERAL RADIO COMPLIANCE

ITEM

SPECIFICATION

Stimulator 
Bluetooth

Module FCC ID: 2AA9B05 

Radio Frequency 
(RF) Range

2402 MHz to 2480 MHz

Base Station

FCC ID: 2AT2D-BASE0017 

Radio Frequency 
(RF) Range

13.56 MHz

 

2402 MHz to 2480 MHz

LTE Module

FCC ID: XPY2AGQN4NNN

Radio Frequency 
(RF) Range

Device operates within approved frequencies 
overlapping with the following cellular bands: LTE 
2,1900 PCS UP | LTE 25,1900+ UP | LTE 35,TD PCS 
Lower DOWN | UMTS CH 2 UP | UMTS CH 25 UP | 
UMTS CH 35 DOWN |

Содержание Trio

Страница 1: ...PATIENT GUIDE Caution Federal law restricts this device to sale by or on the order of a physician LBL 5117 Rev C AUG 2019...

Страница 2: ...0 888 699 1009 www CalaHealth com Copyright c 2018 Cala Health Inc All Rights Reserved Cala Health Cala and Cala Trio are trademarks of Cala Health Inc registered in the U S and other countries Patent...

Страница 3: ...herapy Session with Cala Trio 19 5 1 How to Stop Cala Trio Therapy 21 5 2 How to Rate Your Tremor with Cala Trio 21 5 3 How to Remove Cala Trio 22 6 0 Caring for Cala Trio 23 6 1 How to Charge Cala Tr...

Страница 4: ...ns electronic equipment Properly dispose in accordance with local regulations Complies with United States Product Safety Standards Sold by prescription only Caution Federal law restricts this device t...

Страница 5: ...objects and from water drops vertically falling on Cala Trio when it is tilted up to 15 from vertical Do not immerse in a bathtub or use while swimming Cala Trio is rated for these temperature limits...

Страница 6: ...for adults with essential tremor Meaningful relief is usually observed after use Electrodes embedded in a cloth band Cala Trio Band deliver therapy to nerves in the wrist Cala Trio therapy is deliver...

Страница 7: ...a wristwatch secured with the Cala Trio Band Is worn on the wrist of the prescribed hand Cala Trio Band Contains electrodes Delivers therapy to nerves in your wrist Designed for either right or left h...

Страница 8: ...evices or implanted metal in the wrist Do not use Cala Trio while Sleeping Driving Bathing Operating machinery Doing any activity in which possible involuntary muscle contractions due to therapy may c...

Страница 9: ...g swimming or bathing Do not use Cala Trio simultaneously with High frequency surgical equipment as this may result in electrical burns and or possible damage to Cala Trio Electronic monitoring equipm...

Страница 10: ...skin irritation including electrical stimulation burns of the skin which may cause focal pinpoint edema erosion and crusting Store Cala Trio in the included microfiber bag to prevent exposure to dust...

Страница 11: ...cur that is not covered in the Patient Guide please contact Cala Health at 888 699 1009 or CustomerSuccess CalaTrio com 3 3 Adverse Reactions The following are possible minor moderate risks or adverse...

Страница 12: ...g Cala Trio Positioning and fastening Cala Trio on your wrist correctly is important to therapy success Check your delivery ticket to verify the size and handedness of the band It is essential that th...

Страница 13: ...nsures a good connection between the electrodes and wrist Never submerge Cala Trio in water If there is any excess oil or lotion on your wrist wash with soap and water and rinse well before wearing Ca...

Страница 14: ...CalaTrio com Note In order to conserve battery Cala Trio goes into SLEEP mode and fades to black if you are not actively pressing any buttons Press any button to wake up Cala Trio Step 1 Press the MAI...

Страница 15: ...position to do your Tremor Task see left You can find your Tremor Task in your prescription information or at my CalaTrio com OR Outstretched postural hold Wing beating postural hold Step 5 Perform yo...

Страница 16: ...e g you were walking or talking during the Tremor Task reset Cala Trio by pressing and holding the UP and MAIN buttons simultaneously for 3 seconds 4 3 Setting Stimulation Intensity for Therapy After...

Страница 17: ...ensation right away Step 3 As you continue to press the UP button you should feel a tingling sensation in your hand and fingers in the areas highlighted in the images above UP button To set the intens...

Страница 18: ...eel a stinging sensation if you did not wet your wrist sufficiently before fastening Cala Trio See the note below to add more water You should not feel the tingling sensation in your pinky Additionall...

Страница 19: ...re given the option press the DOWN button and then MAIN to skip until next session Step 4 If prompted do your Tremor Task i e outstretched postural hold or wing beating postural hold To complete your...

Страница 20: ...the intensity as needed to maintain a consistent sensation during therapy and across sessions To stop the ramp to your preset press any button Press the UP button to increase intensity Press the DOWN...

Страница 21: ...indicate therapy has stopped or is complete If you were prompted to do your Tremor Task before therapy it will prompt you to perform your Tremor Task again after therapy repeat section 5 0 steps 3 and...

Страница 22: ...Step 2 Unfasten the band to release the Velcro connection Step 3 Remove Cala Trio from wrist Note Leave the stimulator and band attached until you are prompted to replace the band Cala Trio will disp...

Страница 23: ...n order to charge Step 1 Place the stimulator with the band attached into the base station Cala Trio displays that it is charging and then fades to sleep after a few seconds The base station will also...

Страница 24: ...to the new band in the base station for 15 seconds in order to clear the replace band message 6 3 How to Change Stimulation Intensity Preset Change the preset if you would prefer a different stimulati...

Страница 25: ...n to highlight reset Then press the MAIN button Step 3 Use the UP button to increase the therapy to an appropriate level See steps 2 3 in section 4 3 on page 17 for more detail Step 4 Press the MAIN b...

Страница 26: ...s stopped To resolve the issue Step 1 Press MAIN button to exit the warning Step 2 If prompted complete the post therapy Tremor Task and rating Step 3 Remove Cala Trio from your wrist Step 4 Ensure th...

Страница 27: ...available for ten days after the first appearance of this message See section 6 2 on page 24 for directions on disconnecting and connecting the stimulator and band Adjust Band on Wrist Follow the same...

Страница 28: ...button for a few seconds to reset the stimulator Use stimulator as instructed If the error persists contact Cala Health at 888 699 1009 or CustomerSuccess CalaTrio com Temperature Exceeded Cala Trio...

Страница 29: ...were not blinded and knew the patient s therapy allocation However the patient and the raters assessing the effectiveness were blinded The patients tremor severity was assessed before during and immed...

Страница 30: ...ly after a 40 minute stimulation session and it is unknown if repeated treatment will provide better worse or similar benefit The active device provided stimulation that could be felt by the patient w...

Страница 31: ...Output Current 20 8 mA at 10 k Pulse Duration 20 300 sec Fixed Pulse Repetition Frequency 20 150 Hz Fixed Pulse Pattern Continuous bursts tuned to tremor frequency between 4 12 Hz THERAPY SESSION Tim...

Страница 32: ...Relative Humidity Range Atmospheric Pressure Range 5 40 C 41 104 F 15 90 700 1060 hPa Transport and Storage Parameters Cala Trio Temperature Range Relative Humidity Range Atmospheric Pressure Range Sh...

Страница 33: ...not tamper with modify or attempt to perform maintenance or servicing on Cala Trio GENERAL RADIO COMPLIANCE ITEM SPECIFICATION Stimulator Bluetooth Module FCC ID 2AA9B05 Radio Frequency RF Range 2402...

Страница 34: ...kV for power supply lines Mains power quality should be that of a typical commercial or hospital environment GUIDANCE AND MANUFACTURER S DECLARATION ELECTROMAGNETIC EMISSIONS Cala Trio is intended for...

Страница 35: ...short interruptions and voltage variations on power supply input lines IEC 61000 4 11 Voltage Dips 30 reduction 25 30 periods At 0 Voltage Dips 30 reduction 25 30 periods At 0 Mains power quality shou...

Страница 36: ...fixed RF transmitters as determined by an electromagnetic site surveya should be less than the compliance level in each frequency range b NOTE 1 At 80 MHz and 800 MHz the higher frequency range appli...

Страница 37: ...aration distance according to frequency of transmitter M 150 kHz to 80 MHz d 1 2 P 80 MHz to 800 MHz d 1 2 P 800 MHz to 2 7 GHz d 2 3 P 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8...

Страница 38: ...m 385 380 390 TETRA 400 Pulse modulation b 18 Hz 1 8 0 3 27 450 430 470 GMRS 460 FRS 460 FM c 5 kHz deviation 1 kHz sine 2 0 3 28 710 704 787 LTE Band 13 17 Pulse modulation b 217 Hz 0 2 0 3 9 745 78...

Страница 39: ...RFID 2450 LTE Band 7 Pulse modulation b 217 Hz 2 0 3 28 5240 5100 5800 WLAN 802 11 a n Pulse modulation b 217 Hz 0 2 0 3 9 5500 5785 a For some services only the uplink frequencies are included b The...

Страница 40: ...er only that the Cala TrioTM that such customer purchased the Product shall be free from defects in materials and workmanship under normal use and will perform in accordance with the Product specifica...

Страница 41: ...41 LBL 5117 Rev C AUG 2019...

Страница 42: ...42 Questions about Cala Trio Visit CalaTrio com FAQs...

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