Radiancy Kyroback User Manual

Relief. At Last.
For an effective treatment,
read the entire User Manual
before using Kyrobak.
User Manual
Contents
Operating Your Kyrobak 10
2
Cushion
Know Your Kyrobak
Handle
Power Supply Connection
On/Off + Treatment Speed Button
Contents
What’s Included
Device Features
Kyrobak Device
Power Supply
Kyrobak is a revolutionary
home-use device, clinically
proven to treat non-specic
lower back pain using
Continuous Passive Motion
(CPM). This non-invasive,
gentle approach provides you
with a simple, relaxing method
to treat your pain. All you need
is 10 minutes a day. Lie back,
relax and leave the rest to
Kyrobak.
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Safety Instructions
Warnings
Do not use without clothing.
Do not use in a wet or damp place.
Do not use on a moving surface like a waterbed.
Do not cover yourself with a blanket or any other cover during treatment.
Keep your hands away from all moving parts during treatment.
Keep out of reach of children.
Do not stand or jump on the device.
Only use this device for its intended purpose and as described in this User Manual.
Do not smoke during treatment.
Do not eat or drink during treatment.
Cautions
Do not reach for a device that has fallen into water while it is plugged in.
Unplug the Power Supply from the main source of power before removing it from the water.
Do not place or store this device near water or other liquids.
This device should never be left unattended while plugged in.
Keep the area around the Power Supply clear, with nothing on or underneath it.
Do not use the Power Supply if the cord or plug is damaged in any way.
Do not use this device near or
rest it on ammable objects
such as paper or cloth, etc.
Always unplug the Power Supply from the electrical outlet immediately after use.
This device should only be used with the supplied Power Supply.
Always turn off this device when
you have nished using it.
Do not open the outer casing of the Unit. This might harm the Unit and will void any warranty.
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Kyrobak is only for people who suffer from
non-specic lower back
pain. If you have been diagnosed with, or have any of the following conditions, this product is not for you.
If you have had any back surgery, including spinal fusion.
If you have acute Lower Back Pain (LBP).
If you have Listhesis (spinal misalignment of grade II and above).
If you have orthostatic hypotension (dizziness upon standing suddenly).
If you have irradiating pain to the leg/s.
If you have a slipped disc.
If there is central pressure on the spinal cord that results in the following symptoms: urinary problems, numbness in both legs and/or loss of balance.
If you have systemic rheumatic disorders (i.e. rheumatoid arthritis, lupus).
If you have hip or knee symptomatic osteoarthritis.
If you are unable to get up from the oor without help.
If you have psychiatric disorders.
If you are under 18.
If you are pregnant.
If you weigh over 120 kg/265 lbs.
Contraindications: DO NOT USE:
Please consult a physician before using Kyrobak:
Before You Start
If you are suffering from low back pain with evidence of underlying disease or abnormalities.
If your back pain is induced by a recognized, suspected or impending fracture.
If you suffer from any form of developing or new neurological decit.
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How to Use Kyrobak
Getting Started
Wear comfortable clothing that covers your lower back.
Set up in a quiet place close to a power outlet with enough room to lie down comfortably.
Place Kyrobak on the oor, bed, couch or any other smooth, at surface. When using the device on the oor, you can place it on a rug or mat.
Treatment Regimen
We recommend you use Kyrobak for one 10 minute treatment per day. You can use it up to 3 times a day, but wait at least 4-6 hours between each treatment.
1. Connect power supply into the Kyrobak unit.
2. Plug power supply into a household outlet.
1
6
2. Lie Down
Make sure
Your buttocks are positioned in the center of the Cushion.
Your body is straight, without slanting to one side or the other.
Your back and upper body are on the oor.
Getting in the right position is the key to an effective treatment
How to Use Kyrobak
1. Carefully Sit in the Center of the Cushion
Make sure
Your legs are facing the cylinder shaped side of the device.
Your buttocks are positioned in the center of the Cushion.
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2
7
Correct Pelvic Position Incorrect Pelvic Position
INCORRECT INCORRECTCORRECT
It is a natural instinct to scoot down a bit when lying down. If this happens, just scoot yourself right back into place with your buttocks squarely in the center of the cushion.
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Position 2
Legs elevated on a chair with the
thighs at a 90º angle from the oor.
Position 1
Legs bent at a 30º to 45º angle
with the feet at on the oor.
2
Leg Position
Your legs can be positioned in two ways:
How to Use Kyrobak
1
9
INCORRECT
Head and Neck Support
If you feel discomfort in your head or neck, place a small, soft pillow under your neck and head. Remember to keep your body straight with your hands at your sides.
INCORRECT
CORRECT
Do not touch the device with your arms or hands.
Arm Position
Position your arms loosely at your sides at a 30º to 45º angle from your body.
Correct Arm Position
Incorrect Arm Position
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Operating Your Kyrobak
1. Turn the Device On
Press the On/Off Button until the device begins to gently rotate. (a)
2. Set the Treatment Speed
Set the desired speed by pressing the On/Off button after the Unit has turned on. (b)
The default speed is Low.
Push the On/Off button again to go
Medium.
Push the On/Off button again to go
to High.
One more push of the button will
return the device to the default
setting of Low.
a
b
The rst time you use Kyrobak, stay at least one
minute on each speed before going to the next. Stay at the speed that is most comfortable for you. The next time you use Kyrobak, you can start at the last speed used during your previous treatment.
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c
3. Begin Treatment
With your arms at your side at a 30° to 45° angle from the body, lie back and relax. You will feel gentle, continuous movement in your pelvis area. If at any point during the treatment you feel your body shifting to one side of the device, you should realign your pelvis to the center of the Cushion and continue the treatment. After 10 minutes, the treatment will automatically stop and the device will shut down. To stop the treatment for any reason, hold down the On/Off button until the device stops moving and turns off.
4. End Treatment
When the treatment is complete and Kyrobak stops moving, it is recommended to relax for one or two minutes before getting up. To get up, gently roll onto one side (c) and then, using your elbows as support, push yourself into a sitting position and stand up. (d)
d
When you are nished, unplug Kyrobak and store it
in a safe, dry place, away from children and pets.
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If Kyrobak does not start:
Disconnect the Power Supply from both ends, wait 2 minutes, plug it in and try again.
Make sure the cable is connected securely to the device.
Make sure the Power Supply is connected securely to the electrical outlet.
Make sure the electrical outlet is working properly.
Press the On/Off button down for an extended time until the unit turns on.
In rare cases, the On/Off button will appear to be blinking when the device is turned on. This is an indication that the device is faulty and that customer service should be contacted.
Troubleshooting
Positioning yourself correctly on the device is the key to an effective treatment.
Kyrobak uses a very gentle movement on the lower back. This gentle movement is clinically proven to alleviate lower back pain.
Kyrobak treats lower back pain and provides a lasting effect. However, you may not feel an
immediate alleviation of pain right after the rst time you use Kyrobak. The more you use
the device, the more relief you should experience.
Important
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Technical Specications
Treatment Time
10 minutes
Classication
Internally Powered Equipment, Type BF
Mode of Operation
Continuous
Transport and Storage Conditions
Temperature: -25° C to 70°C Humidity: 0-93% RH
Electrical Requirements
9-12Vdc, 3A Max from an AC/DC adaptor In: 100-240Vac, 50/60Hz, 71-99VA, 0.9A
Operating Conditions
Temperature
Humidity: 15%-93% RH
Atmospheric pressure:
700 hPa to 1060 hPa.
Label Explanation
Located at the bottom of the device.
Indicates the need to consult instructions for use.
Manufacturer
Indicates the Authorized Representative in the European Community
Indicates the temperature limitation.
Degree of protection against electric shock: Type BF applied part
CE mark represents the compliance to the European Low Voltage Directive 2006/95/EC and the Electromagnetic Compatibility Directive 2004/108/EC.
Protect the environment by not disposing of this product with household waste (2002/96/EC). Check your local authority for recycling advice and facilities (Europe only).
Catalogue Number: Indicates the manufacturer›s catalogue number so that the
device can be identied.
Serial Number: Indicates he manufacturer›s
serial number so that a specic device can be identied.
Technical Specications
Weight: 3.15 kg Physical Dimensions: 12 x 45 x 39 cm (w/d/h)
Product Labels & Symbols
This section describes the labels
afxed to the Kyrobak and
found in the user manual. It is recommended that users review the meaning of these labels for everyday usage, and in case any details are needed for service.
The table below briey reviews
a number of the internationally recognized symbols that are found on the Kyrobak main Unit and its external package.
Label Explanation
The package may be recycled.
IP21
IP21 according to IEC60529, Degrees of Protection Provided by Enclosures (IP Code).
40° C5° C
Manufacturer's declaration for electromagnetic compatibility (EMC) for the Kyrobak according to EN 60601-1-2:2007 (Tables 1, 2, 4 and 6)
Table 1
Guidance and manufacturer's declaration – electromagnetic emissions – Kyrobak
The Kyrobak is intended for use in the electromagnetic
environment specied below; The customer or the user of the
Kyrobak should assure that it is used in such an environment.
Emissions test Compliance
Electromagnetic environment
- guidance
RF emissions CISPR 11
Group 1
The Kyrobak uses RF energy only for its internal 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
The Kyrobak is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
Harmonic emissions IEC 61000-3-2
Class A
Voltage
uctuations/ icker
emissions IEC 61000-3-3
Complies
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Service Centers
You are allowed to perform only the servicing listed in this User Manual. Radiancy is responsible for the effects on safety, reliability and performance of the equipment only if repairs are carried out by Radiancy authorized personnel.
Radiancy Inc.
40 Ramland Road South, Suite 200 Orangeburg, NY 10962, USA +1 888.661.2220 +1 845.398.1647
Customer Support
888.998.4713
International Standards
Electrical Safety: Power Supply: double insulation This appliance is not suitable for use in the
presence of ammable anesthetic mixture
with air or with Oxygen or Nitrous Oxide. The Quality Management System of Radiancy Ltd. complies with the Quality Management Standard EN ISO 13485. Kyrobak complies with the following international standards and directives: General Requirements for Basic Safety and Essential Performance, 3rd Ed.: IEC60601-1:2005/EN60601-1:2006 Electromagnetic Compatibility: IEC 60601-1-2:2007
Electromagnetic Compatibility Kyrobak requires special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in this document. FCC, Class B 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. This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the manufacturer’s instruction manual, may cause interference to radio communications. These limits are designed to provide reasonable protection against harmful interference in a residential installation. Notice: The FCC regulations provide that changes or
modications not expressly approved by
Radiancy Inc. could void your authority to
operate this equipment.
Manufacturer
Radiancy Israel Ltd. 5 Hanagar Street 4527708 Hod Hasharon Israel
European Representitive
Obelis s.a. Bd. Général Wahis 53 B-1030 Brussels, Belgium Phone: 32.2.732.59.54 Fax: 32.2.732.60.03 E-mail: mail@obelis.net
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Table 2
Guidance and manufacturer's declaration – electromagnetic immunity – Kyrobak
The Kyrobak is intended for use in the electromagnetic environment specied below; The customer or the user of the Kyrobak should assure that it is used in such an environment.
Immunity test
IEC 60601-1-2 Test level
Compliance level Electromagnetic environment - guidance
Electrostatic discharge (ESD) IEC 61000-4-2
±6 kV contact ±8 kV air
±6 kV contact ±8 kV air
Floors should be wood, concrete or Ceramic tile. If oors 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
±2 kV for power supply lines Not Applicable
Mains power quality should be that of a typical public low-voltage power supply network that supplies buildings used for domestic purposes, commercial or hospital Environment.
Surge IEC 61000-4-5
±1 kV differential mode ±2 kV common mode
±1 kV differential mode ±2 kV common mode
Mains power quality should be that of a typical public low-voltage power supply network that supplies buildings used for domestic purposes, commercial or hospital Environment.
Voltage dips, short interruptions and voltage variations on power supply input lines
IEC 61000-4-11
<5 %UT (>95 %dip in UT) for 0,5 cycle
40 %UT (60 %dip in UT) for 5 cycles <5 %UT
70 %UT (30 %dip in UT) for 25 cycles <5 %UT
<5 %UT (>95 %dip in UT) for 5 s
<5 %UT (>95 %dip in UT) for 0,5 cycle
40 %UT (60 %dip in UT) for 5 cycles <5 %UT
70 %UT (30 %dip in UT) for 25 cycles <5 %UT
<5 %UT (>95 %dip in UT) for 5 s
Mains power quality should be that of a typical public low-voltage power supply network that supplies buildings used for domestic purposes, commercial or hospital Environment.
If the user of the Kyrobak requires continued operation during power mains interruptions; it is
recommended that Kyrobak be powered from an uninterruptible power Supply or a battery.
Power frequency (50/60
Hz)magnetic eld IEC
61000-4-8
3 A/m 3 A/m
Power frequency magnetic elds should be at levels characteristic of a typical public
low-voltage power supply network that supplies buildings used for domestic purposes, commercial or hospital Environment.
NOTE: UT is the a.c. mains voltage prior to application of the test level.
Table 4
Guidance and manufacturer's declaration – electromagnetic immunity – Kyrobak
The Kyrobak is intended for use in the electromagnetic environment specied below;
The customer or the user of the Kyrobak should assure that it is used in such an environment.
Immunity test
IEC 60601-1-2 Test level
Compliance level Electromagnetic environment - guidance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
150 k Hz to 80 MHz
3 V/m
80 MHz to 2,5 GHz
3 Vrms
3 V/m
Portable and mobile RF communications equipment should be used no closer to any part of the Kyrobak, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance
d = 1.17√P d = 1.17√P 80 M Hz t o 800 MHz d= 2.34√P 800 MHz t o 2,5 GHz
where P i s 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 xed R F transmitters, as determined by an electromagnetic site survey ,a should be
less than the compliance level in each frequency range .d
Interference may occur in t he 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 reection from structures objects and people.
a
Field strengths from xed 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 xed RF transmitters, an electromagnetic site survey should be considered. If the measured eld strength in the location in which the Kyrobak is used exceeds the applicable RF compliance level above, the Kyrobak should be observed to verify
normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the Kyrobak. b
Over the frequency range 150 kHz to 80 MHz, eld strengths should be less than 3 V/m.
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Table 6
Recommended separation distances between portable and mobile RF communications equipment and the Kyrobak
The Kyrobak is intended f or us e in an electromagnetic environment in which radiated RF disturbances are Controlled. The customer or the user of t Kyrobak can help prevent electromagnetic interference by maintaining a minimum distance between port able and m obi le RF communications equipment (transmitters)and the Kyrobak as recommended below, according t o t he maximum out put power of t he communications equipment
Rated maximum output power of transmitter Watts [W]
Separation distance according to frequency of transmitter Meters [m]
150kHz to 80MHz
d = 1.17√P
80MHz to 800MHz
d = 1.17√P
800MHz to 2.5GHz
d= 2.34√P
0.01 0.12 0.12 0.24
0.1 0.37 0.37 0.74
1 1.17 1.17 2.34
10 3.7 3.7 7.4
100 11.7 11.7 23.4
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.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reection from
structures, objects, and people.
For videos and tips on how to use Kyrobak visit our website at:
www.HowToKyro.com
For further assistance contact our customer support:
888.998.4713
LIT-00179/Rev A.01/Oct.2013
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