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Questions about Cala Trio? Visit CalaTrio.com/HCPFAQs

LBL-5122 Rev C NOV 2019

GUIDANCE AND MANUFACTURER'S DECLARATION - ELECTROMAGNETIC IMMUNITY

IMMUNITY TEST

IEC 60601 TEST LEVEL

COMPLIANCE LEVEL

ELECTROMAGNETIC 
ENVIRONMENT GUIDANCE

Voltage dips, 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 
should be that of a typical 
commercial or hospital 
environment. If the user of 
Cala Trio requires continued 
operation during power 
mains interruptions, it is 
recommended that Cala 
Trio be powered from an 
uninterruptible power supply 
or a battery.

Voltage Dips > 95% reduction, 0.5 period   
At 0°, 45°, 90°, 135°, 180°, 225°, 270° and 
315° 

Voltage Dips > 95% reduction, 0.5 period   
At 0°, 45°, 90°, 135°, 180°, 225°, 270° and 
315° 

Voltage Dips > 95% reduction, 1 period  
At 0°

Voltage Dips > 95% reduction, 1 period  
At 0°

Voltage Interruptions > 95% reduction, 
250/300 periods

Voltage Interruptions > 95% reduction, 
250/300 periods

GUIDANCE AND MANUFACTURER'S DECLARATION - ELECTROMAGNETIC IMMUNITY

IMMUNITY  
TEST

IEC 60601 TEST 
LEVEL

COMPLIANCE 
LEVEL

ELECTROMAGNETIC ENVIRONMENT GUIDANCE

Conducted RF 
IEC 61000-4-6

3 Vrms  
150 kHz to 80 
MHz (6 Vrms in 
ISM and amateur 
radio Bands within 
150kHz – 80MHz) 

3 Vrms

Portable and mobile RF communications equipment should be used no closer to 
any part of Cala Trio, including cables, than the recommended separation distance 
calculated from the equation applicable to the frequency of the transmitter. 

Recommended separation distance 

d = 1.2√P

Radiated RF 
IEC 61000-4-3

10 V/m 
80 MHz to 2.7 GHz

10 V/m

d = 1.2√P   80 MHz to 800 MHz 
d = 2.3√P   800 MHz to 2.7 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 metres 

(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

 

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.

a

 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 Cala Trio 

is used exceeds the applicable RF compliance level above, Cala Trio should be observed to verify normal operation. If abnormal performance is 

observed, additional measures may be necessary, such as reorienting or relocating Cala Trio. 

b

 Over the frequency range 150 kHz to 80 MHz, 

field strengths should be less than 3 V/m.

IMMUNITY TO RF WIRELESS COMMUNICATIONS EQUIPMENT

Test 
Frequency 
(MHz)

Band 

 a)

MHz)

Service 

a)

Modulation 

b)

Maximum Power (W)

Distance (m)

IMMUNITY TEST LEVEL 
(V/m)

2450

2400 – 2570

Bluetooth, 
WLAN, 
802.11 b/g/n, 
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 carrier shall be modulated using a 50 % duty cycle square wave signal. 
c) As an alternative to FM modulation, 50 % pulse modulation at 18 Hz may be used because while it does not represent actual modulation, it 
would be worst case.

Summary of Contents for Cala Trio CT1-STR

Page 1: ...HEALTH CARE PROFESSIONAL GUIDE Caution Federal law restricts this device to sale by or on the order of a physician LBL 5122 Rev C NOV 2019...

Page 2: ...la Trio 12 7 0 Caring for Cala Trio 13 7 1 How to Charge Cala Trio 13 7 2 How to Replace Cala Trio Band 13 7 3 How to Change Stimulation Intensity Preset 13 7 4 How to Recalibrate Cala Trio 14 7 5 How...

Page 3: ...from fingers and small 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 t...

Page 4: ...ef of hand tremor is desired i e before activities involving your hands such as meals or writing Cala Trio therapy is recommended for use at least twice daily to help with the activities listed above...

Page 5: ...ncrease the risk of arrhythmia Do not apply stimulation over open wounds or rashes or over swollen red infected or inflamed areas or skin eruptions e g phlebitis thrombophlebitis varicose veins etc Do...

Page 6: ...n that lack normal sensation Keep out of the reach of children and pets The device is single patient use by the individual for whom it has been prescribed It should not be worn by anyone else or on an...

Page 7: ...subject s wrist circumference with a wrist measurement device measuring tape Measure over the wrist bone 2 Wrap the measuring tape around the wrist There should be no visible gaps between the measuri...

Page 8: ...on points toward the elbow not the hand Step 3 Center the stimulator on the back of your wrist as close to the hand as possible without hindering wrist movement Note Correct placement of the Cala Trio...

Page 9: ...p Cala Trio Step 1 Press the MAIN button to wake up the stimulator You should see Cala Trio displayed UP button DOWN button MAIN button Step 2 From Cala Trio press and hold the MAIN button for 3 secon...

Page 10: ...rs in the areas highlighted in the images above Note Tingling sensation varies depending on Cala Trio positioning and amount of water on the wrist You may feel a stinging sensation if you did not wet...

Page 11: ...postural hold To complete your Tremor Task You can find your Tremor Task in your prescription information Get in position to do your Tremor Task Press the MAIN button to start the measurement Note On...

Page 12: ...will ask you if your Tremor Task To rate how your tremor level has changed compared to before therapy Step 1 Press the MAIN button to bring up the rating display Step 2 Press UP button or DOWN button...

Page 13: ...handedness of the band matches your prescription information Step 2 Remove the used band by unsnapping it from the stimulator Step 3 For the new one align the half circle cut outs on the back of the b...

Page 14: ...to save If you do not want to save the calibration press DOWN and then MAIN to exit Cala Trio therapy is re calibrated and ready to use Step 2 Release the buttons and Cala Trio will automatically res...

Page 15: ...d the MAIN 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 Charge Device Cala Tr...

Page 16: ...ic Thalamotomy Gamma Knife Radiosurgical Thalamotomy and focused ultrasound for the treatment of tremor 3 Suspected or diagnosed epilepsy or other seizure disorder 4 Pregnant 5 Swollen infected inflam...

Page 17: ...ssion The subject reported their improvement on the 7 point CGI I scale defined as follows 1 Very much improved 2 Much improved 3 Minimally improved 4 No change 5 Minimally worse 6 Much worse 7 Very m...

Page 18: ...ham or treatment and to the spiral order e g baseline during or after stimulation The independent blinded raters rated the spirals using the 5 point 0 4 TETRAS scale using a 0 5 point resolution The s...

Page 19: ...prior form of treatment for ET Subjects enrolled in the study TABLE 3 Baseline characteristics of Effectiveness Analysis Population N 77 Overall N 77 Treatment N 40 Sham N 37 Age of onset in years Mea...

Page 20: ...56 0 76 0 35 0 102 0001 0 263 Sham 36 0 39 0 60 0 17 0 108 0 0006 1 One of the 77 EAP subjects had missing post stimulation TETRAS Spiral rating data therefore the N for this analysis is 76 TABLE 6 Su...

Page 21: ...reatment 40 2 29 0 70 0 51 0 70 0 56 0 72 Sham 37 2 16 0 57 0 34 0 44 0 36 0 54 Kinetic Treatment 40 2 29 0 47 0 50 0 51 0 53 0 59 Sham 37 2 27 0 47 0 31 0 38 0 34 0 43 Upper Limb Total Treatment 40 6...

Page 22: ...After stimulation the responder rate was 27 5 compared to 16 7 in the sham group TABLE 12 TETRAS Spiral responder rate during and after stimulation EAP N 77 During Stimulation After Stimulation Respo...

Page 23: ...onitored by an independent Safety Reviewer who is a board certified neurologist and movement disorder specialist The Safety Reviewer could make recommendations for protocol modifications or trial disc...

Page 24: ...ile 27 5 had a 1 0 point improvement directly after 40 minutes of device use These differences are clinically meaningful The duration of the effect was not assessed beyond the assessments five minutes...

Page 25: ...ype Permanent rechargable battery not serviceable or replaceable Power Source AC 50 60 Hz Rated Voltage 100 240V Max Current 0 5 A Duration Fully charged battery lasts 5 therapy sessions MEASUREMENT A...

Page 26: ...nal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions CISPR 11 Class B Cala Trio is suitable for use in all esta...

Page 27: ...output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in metres m Field strengths from fixed RF transmitters as dete...

Page 28: ...um 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 powe...

Page 29: ...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 specifications set fo...

Page 30: ...30 Questions about Cala Trio Visit CalaTrio com HCPFAQs LBL 5122 Rev C NOV 2019...

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