Manamed ManaSport+ ManaFlow 51 User manual

INSTRUCTIONS FOR USE
Noninvasive
UItrasound Device
Customer Service
Toll Free: 888-508-0712
Email: [e-mail]
Web: www.manamed.com
Manufactured For:
5240 W Charleston Blvd., #150,
Las Vegas NV 89146
Scan QR Code to watch
Instructions for Use
TD-MSPORT02-IFU, Rev. 01
Copyright 2023 ManaMed®, LLC

Table of Contents
Purpose of Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Page 3
Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Page 3
Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Page 3
Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Pages 3 - 4
Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Page 4
Be Aware of the Following . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Page 4
Adverse Reactions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Page 4
Quick Start Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Pages 5 - 7
Optional Smart Device App Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Pages 8 - 10
User Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Page 11
Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Page 11
Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Page 11
Using the AC Adapter / Battery Charger . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Page 11
Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Page 11
Ultrasound Gel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Page 12
ManaSport+ Expected Service/Shelf Life . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Page 12
Limited Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Page 12
Technical . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Page 12
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Page 13
Instructions for reporting adverse events . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Page 13
Summary of ManaSport+ Wireless Functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Page 13
Summary of ManaSport+ Wireless Security Methods . . . . . . . . . . . . . . . . . . . . . . . . Page 13
Radio Frequency Wireless Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Page 13
Radio Frequency Wireless Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Page 14
Electromagnetic Compatibility Tables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Pages 15 - 16
Standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Page 17
FCC Statement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Page 17

PURPOSE OF DEVICE
The ManaSport+ is a portable and rechargeable prescriptive device.
It is intended to be used for adults only, under the direction of a medical professional. The ManaSport+ is intended for Home Use.
INDICATIONS FOR USE
CONTRAINDICATIONS
Do not use this device on persons whose pain syndromes are undiagnosed. Contraindications for the use of ultrasound include:
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t0WFSUIFFZFT
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t0WFSUIFSFQSPEVDUJWFPSHBOT
t0WFSUIFQSFHOBOUVUFSVT
t0WFSBIFBMJOHCPOFGSBDUVSF
t0WFSBOBDUJWFJNQMBOUFENFEJDBMEFWJDFTVDIBTBOJNQMBOUFEEFFQCSBJOTUJNVMBUJPOEFWJDF
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t
Ischemic tissues in individuals with vascular disease where the blood supply would be unable to follow the increase in metabolic demand and tissue necrosis might result
t Ultrasound therapy should not be used for symptomatic local pain relief unless etiology is established or unless a pain syndrome has been diagnosed
tApplication over parenchymatous organs – liver, spleen, lungs, endocrine glands, gonads
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tAllergies to the applied ultrasound gels
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t5PUBMIJQBSUISPQMBTUJFTXJUINFUIZMNFUIBDSZMBUFPSIJHIEFOTJUZQPMZFUIZMFOF5IFTFIBWFBIJHIDPFóDJFOUPGBCTPSQUJPONPSFUIBOTPGUUJTTVF
and the prosthesis could loosen due to unstable cavitation in the cement
t
Arthroplasties—the eect on bony ingrowth arthroplasties is not well dened; for this reason the most prudent course is avoiding ultrasonic therapy over these areas
tIn an area of the body where infectious disease is present
tBlood vessels in poor condition should not be treated as the vessel walls could rupture as a result of the treatment
t
Patients suering from cardiac disease should not receive treatment over the cervical ganglia, the stellate ganglion, the thorax in the region of the heart,
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JOPUIFSBSFBTCFDBVTFUIFTUJNVMBUJPOPGQSBDUJDBMMZBOZBòFSFOUBVUPOPNJDOFSWFFTQFDJBMMZUIFWBHVTOFSWFJOUIFCPEZDPVMEDBVTFBDIBOHFJODBSEJBDSBUF
tPatients with thrombophlebitis or other potentially thromboembolic diseases should not be treated because a partially disintegrated clot could
result in an obstruction of the arterial supply to the brain, heart or lungs
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t0WFSBSFBTPGBDUJWFUVCFSDVMPTJT
WARNINGS
t*GUIFUSFBUNFOUJTSFQPSUFEBTQBJOGVMPSUPPIPUBUBOZQPJOUEVSJOHUSFBUNFOUUVSOPòEFWJDFBOESFNPWFUIFEFWJDFGSPNUIFTLJO
t*OTUSVDUUIFQBUJFOUUPJOGPSNUIFQSBDUJUJPOFSJGUIFQBUJFOUGFFMTBOZQBJOPSCVSOJOHEVSJOHUSFBUNFOU
t*OTUSVDUUIFQBUJFOUIPXUPUVSOPòUIF%FWJDFBOESFNPWFUIF"QQMJDBUPSJGUIFQBUJFOUGFFMTBOZQBJOPSCVSOJOHEVSJOHUSFBUNFOU
t5IF%FWJDFTIPVMECFLFQUPVUPGUIFSFBDIPGDIJMESFO
t5IFEFWJDFBOEBDDFTTPSJFTBSFOPUTUFSJMF%0/05BQQMZUIJTEFWJDFBOEBDDFTTPSJFTPWFSBOPQFOXPVOEPSJOøBNFETLJO
t%0/05BQQMZEJSFDUMZPWFSBCPOFUIBUJTOFBSUIFTLJOTVSGBDF
(continued next page)
Apply stationary use of ultrasound to:
Generate deep heat within body tissues for the treatment of selected medical conditions such as the relief of pain, the relief of muscle spasms,
the treatment of joint contractures, and the local increase in circulation.
Apply continuous movement of ultrasound for:
1. Pain.
2. Pain relief, muscle spasms, and joint contractures.
3. Relief of pain, muscle spasms, and joint contractures that may be associated with:
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t#VSTJUJTXJUITMJHIUDBMDJöDBUJPO
t.ZPTJUJT
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4. Relief of pain, muscle spasms, and joint contractures resulting from:
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t$BQTVMBSTDBSSJOH
5. Localized increase in blood ow.
6. Increased range of motion of contracted joint using heat and stretch techniques.
3

tDo not use over sensitive skin areas or in the presence of poor circulation. The unattended use of this device by children or incapacitated
persons may be dangerous. To reduce the risk of buns, electric shock, and re, this device must be used in accordance with the instructions.
tDo not crush the device and its accessories.
tCarefully examine the device and its accessories, and do not use if they show any sign of deterioration.
tDo not tamper with this device and its accessories in any way. There are no user serviceable parts. If for any reason they do not function
satisfactorily, return to the authorized service center at address given.
t%POPUVTFBUUIFTBNFUJNFBTPUIFSUPQJDBMBOBMHFTJDT
tHandle ultrasound applicator with care. Inappropriate handling of the ultrasound applicator may adversely aect its characteristics.
tAn appropriate coupling medium should be used in order to ensure energy transmission to the tissue.
WARNINGS (continued)
Precautions
Precaution should be taken when using the device:
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t0OQBUJFOUTXJUIIFNPSSIBHJDEJBUIFTFT
t0WFSBSFBTXIFSFNFUBMQSPTUIFTJTPSPUIFSNFUBMMJDJNQMBOUTBSFFNCFEEFEJOUJTTVFXIJDINBZGPSNB
reective surface to the ultrasound energy causing unintended irradiation of tissue and excessive heating.
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t0OQBUJFOUTXJUIQFSJQIFSBMBSUFSZEJTFBTF
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t$BVUJPOTIPVMECFVTFEGPSQFSTPOTXJUITVTQFDUFEPSEJBHOPTFEIFBSUQSPCMFNT
t$BVUJPOTIPVMECFVTFEGPSQFSTPOTXJUITVTQFDUFEPSEJBHOPTFEFQJMFQTZ
t$BVUJPOTIPVMECFVTFEJGZPVIBWFBOZPGUIFGPMMPXJOH
- iGZPVIBWFBUFOEFODZUPCMFFEJOUFSOBMMZGPMMPXJOHBOJOKVSZ
-JGZPVSFDFOUMZIBETVSHFSZPSIBWFFWFSIBETVSHFSZPOZPVSCBDL
- if areas of skin lack normal sensations, such as skin that is numb.
4
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t
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t,FFQUIJTEFWJDFBOEJUTBDDFTTPSJFTPVUPGSFBDIPGDIJMESFOBOEQFUT*GTXBMMPXFEHFUNFEJDBMIFMQPSDPOUBDUB1PJTPO$POUSPM$FOUFSSJHIUBXBZ
t%POPUVTFUIJTEFWJDFJOIJHIIVNJEJUZBSFBTTVDIBTBCBUISPPN
t4UPQVTJOHUIJTEFWJDFBUPODFJGZPVGFFMEJTDPNGPSUEJ[[JOFTTPSOBVTFBBOEDPOTVMUZPVSQIZTJDJBO
t%POPUBUUFNQUUPNPWFUIFVMUSBTPVOEIFBEXIJMFUIFEFWJDFJTPQFSBUJOH
tFor ultrasound treatment, only use the ultrasound applicator sold with this device.
tWhen applying ultrasound by means of any applicator, ultrasound gel shall be used for correct passage of the ultrasound waves. It is
recommended to use an FDA cleared water-based conductive gel, specically 40/0.&%5&$)/0-0(:*/$(FM, The applicators
have not been tested for use with other gels or oils and can be damaged.
t0OQBUJFOUTXJUIIFNPSSIBHJDEJBUIFTFT
t0WFSBSFBTXIFSFUIFSFJTTFOTPSZJNQBJSNFOUPSTFOTPSZMPTT
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t0WFSUIFBOUFSJPSBTQFDUPGUIFOFDL
t0OQBUJFOUTXIPBSFGFCSJMF
Radio Frequency: This unit generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instructions,
may cause harmful interference to other devices in the vicinity. Harmful interference to other devices can be determined by turning this unit oand
on. Try to correct the interference using one or more of the following: reorient or relocate the receiving device, increase the separation between the
equipment, connect the unit to an outlet on a dierence circuit from UIBUXIJDIUIFPUIFSEFWJDFTBSFDPOOFDUFEBOEDPOTVMU.BOB.FEGPSIFMQIf
the unit isVTFEDMPTFUPSBEJPGSFRVFODZTPVSDFTFH electromagnetic security systems, cellular telephones, RFID or other in-band transmitters), it
may cause abnormal Bluetooth connection.
Be aware of the following:
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tTIJTEFWJDFJTBTZNQUPNBUJDUSFBUNFOUBOEBTTVDITVQQSFTTFTUIFTFOTBUJPOPGQBJOUIBUXPVMEPUIFSXJTFTFSWFBTBQSPUFDUJWFNFDIBOJTN
tSUPQVTJOHUIFEFWJDFBOEDPOTVMUXJUIZPVSQIZTJDJBOJGUIFEFWJDFEPFTOPUQSPWJEFQBJOSFMJFG
tUTFUIJTEFWJDFPOMZXJUIUIFBDDFTTPSJFTSFDPNNFOEFEGPSVTFCZUIFNBOVGBDUVSFS
The accessories may be packaged together with the device or packaged separately as the replacement.
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device malfunction.
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This device contains batteries. If overheating of the device occurred, stop the operation immediately and contact customer support.
Dispose of this battery-containing device according to the local, state, or federal laws.
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Adverse Reactions
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QUICK START GUIDE
CONTENTS: ManaSport+ Device, Applicator, Gel, Adapter, Cap, Strap, Manual
See accompanying documents / User’s Manual. CAUTION: Federal Law restricts this device
to sale by or on the order of a physician.
Date Adjusment
(Decrease)
Date Adjusment
(Increase)
Connect Applicator
Start/stop
ultrasound
Charging Port
Power on/o
Lock/Unlock
Display Symbols and Descriptions
Symbol Name Description
Low Battery
The battery runs low and needs
to be charged prior to use.
Battery Status
Shows how much charge is left in
Five levels of battery status
the battery.
Calendar Broken Star
A 20-minute treatment was not
completed on this calendar day.
Calendar Starmark
A 20-minute treatment was
completed on this calendar day.
Calendar Double
Starmark*
Two-20 minute treatments were
completed on this calendar day.
Calendar Double
Checkmark Plus*
Three or more 20-minute
treatments were completed
on this calendar day.
Ultrasound Symbol
Lock Symbol
Locks the buttons to prevent
unintended operation.
Unlock Symbol
Unlock the buttons to operate
the device.
are having your treatment.
Flashes during use to show you
Countdown Timer
Counts down from 20 minutes to
show treatment time remaining.
Treatment Complete
Automatically displays when count-
down timer reaches zero to show
that treatment is complete.
Charge the battery before use
The ManaSport+ provides non-invasive therapy of low-intensity pulsed ultrasound for the treatment of selected medical conditions such as soft tissue
injuries, shortened tendons due to past injuries and scar tissues, relief of pain, muscle spasms and joint contractures. ManaSport+ transmits a low-intensity
ultrasound signal to the patient’s treatment site through ultrasound gel. The patient will experience little or no sensation while in ultrasound mode.
The ManaSport+ system in a carrying case consists of one ManaSport+
device and the following biocompatible components/accessories.
1) Transducer applicator connected to the ManaSport+ device to generate a low-intensity
ultrasound or stimulation signal at the treatment site.
2) Coupling gel applied to the transducer applicator to transmit the ultrasound signal
to the depth of the treatment site.
3) Strap with a cap to hold the transducer applicator down on the treatment site.
4) Battery charger/adapter to charge the subject device.
5) Sticker Patch to hold the transducer applicator down on the treatment site.
If you suspect you may be missing an item, please contact Customer Service at 888-508-0712.
When the remaining battery of the device cannot last for 20 min, its display will switch to reminding you of recharge
prior to use (Screen 1a). Plug the power supply adapter to the wall socket as well as ManaSport+ using the charging port
located at its bottom end.The BATTERY icon on the device’s display keeps ashing or steady, depending on the state of
the charge. When the battery is charging, the BATTERY icon will keep ashing (Screen 1b). Once the battery is fully
charged, the BATTERY icon will become solid (Screen 1c). Note: The device cannot be used when it is being charged.
Screen 1a Screen 1b Screen 1c
5

QUICK START GUIDE (continued)
Operation 4b
Operation 4a
Operation 4c
Operation 2a
Operation 2e
Operation 2b
Operation 2d
How to install the strap with a cap:
The strap is suitable for a treatment site of extremities. Position the strap with the cap facing up, as shown in the following Operation 2a;
tPull the long end of the strap through the plastic loop, as shown in the following Operation 2b;
tUse 2 ngers of yours to squeeze the cap tabs together to open the cap cover, as shown in the following Operation 2c;
tSlide the strap and place the port of the cap over the treatment site marked with an‘X’ by your physician/doctor, as shown in the following Operation 2d
(Contact your physician/doctor if you are not sure where to locate your treatment site);
tTighten the strap by pulling on the long end and fasten the strap in place, as shown in the following Operation 2e (Note: Do not make the strap too tight);
Operation 2c
Operation 3b
Operation 3a
The strap can provide you with a hand-free treatment. However, if you prefer to continuously move the transducer applicator throughout
your treatment area, you can skip operations 2a to 4c, and only refer to Operation 4a at the bottom of this page.
Specically, please refer to the detailed instructions below for continuously moving the applicator..
a. Apply the ultrasound gel. The entire treatment area should be covered with the ultrasound gel, and the transducer applicator should
also always be covered with the ultrasound gel.
b. Position the transducer applicator at against the skin and keep transducer applicator constantly moving, slowly and with constant
pressure, during treatment.
c. The treatment area should not exceed 2 to 3 times the size of the transducer applicator.
6
Preparation before use:
tRemove the cap from the gel bottle, and hold the transducer applicator, so the cable is down and the smooth side of the applicator is up. Press down the gel bottle
nozzle to pump gel onto the smooth side of the applicator, as shown in the following Operation 4a. You only need on full pump of gel on the applicator (Note: For the
rst time, you may need to press the gel bottle nozzle a couple of times to start the gel owing);
tPlace the transducer applicator with the gel side down into the port of the cap, and the gel will touch the skin over your treatment site, as shown in the following
Operation 4b;
tAlign the lead wire coming out of the transducer applicator with the notch of the cap cover, and close the cap cover, as shown in the following Operation 4c
(Note: The other end of the lead wire of the transducer applicator is connected to the top port of the device);
IMPORTANT:
Patients should ensure the
entire applicator surface is
covered with the ultrasound gel.
Patient should also ensure
complete skin contact with the
treatment applicator before
beginning therapy.
How to install the Sticker Patch with a cap:
The Sticker Patch is suitable for a treatment site of hard-to-reach areas or for convenience.
tRemove the cap from the strap and insert it into the Sticker Patch; The sticky side of the
patch will be on the opposite side of the top of the cap;
tOnce mounted, use 2 of your ngers to squeeze the cap tabs together to open the cap cover,
as shown in the image Operation 3a;
tPlace the port of the cap over the treatment site marked with an‘X’ by your physician/doctor,
as shown in the following

QUICK START GUIDE (continued)
Screen 5a Screen 5b Screen 5c
Screen 5d Screen 5e Screen 5f
To avoid the unintended operation, the device will automatically be locked after 60 seconds of no
operation, or you could click the Lock/Unlock button to lock the device (Screen 5g). After the
20-minute timer counts down to zero, you can see a “Treatment Completed” screen (Screen 5h). It
means a 20-minute treatment of Ultrasound is complete. After showing the “Treatment
Completed” screen for 20 seconds, the device will turn off automatically (alternatively, you could
press and hold the ON/OFF button to turn off the device). Please be aware that you still can press
and hold the ON/OFF button to turn off the device, even though the device is locked.
ManaSport+ Quantity of Treatment and Frequency of Use
ManaSport+ should be used for 20 minutes per day or as prescribed by your doctor. The
ultrasound will be automatically stopped after the maximum timer of 20 minutes runs out. It is very
important to follow your physician/doctor’s protocol to get the full medical benefit of the
treatment. If you have concerns about your treatment, please contact your doctor directly. The
device is a single patient reusable device. This device is prescription only and may not be used
without a physician’s order.
Screen 5g Screen 5h
Screen 7a
Data Record
Your daily use time of Ultrasound is recorded, as shown on Screen 7a. When a 20-minute treatment
is completed, a red starmark will show on the calendar date. When two 20-minute treatments are
completed, two red starmarks will show on the calendar date. When three or more 20-minute
treatments are completed, two red starmarks and one plus will show on the calendar date. When a 20-minute treatment is not completed, a
grey broken starmark will show on the calendar date. Please refer to the above section of “Use of Ultrasound function” for how to view the
data recorded. After the “Set Successfully” screen of Date and Time, the device will automatically proceed to the next screen of Ultrasound
calendar/summary (Screen 7a) and last for 5 seconds. Clicking the + or – button on the right side of the device can show different-month
screens of Ultrasound calendar/Summary. It is worth noting that no patient information (such as age and history) is recorded and stored, so
there is no issue of privacy or security.
Use of Ultrasound function:
Your physician/doctor may have marked your treatment site with an
‘X’. This is the spot to place the transducer applicator to treat your
symptom by using ultrasound. Contact your physician/doctor if you
are not sure where to treat your symptom.
After the above steps are done, you can click the ON/OFF button on the
device to turn it on: After showing the following display screen (Screen
5a) for 2 seconds, the device will then go to the next screen (Screen 5b)
of Date and Time automatically. Follow the instruction of the screen to
conform or change the time and date, and you will see the “Set
Successfully” screen of Date and Time (Screen 5c). Note: The display
screen of Date and Time will only appear for the first time of power on,
or by pressing the ON/OFF and ULTRASOUND buttons simultaneously.
After the “Set Successfully” screen of Date and Time, the device will
automatically proceed to the next screen of Ultrasound
calendar/summary (Screen 5d) and last for 5 seconds. Clicking the +
or – button on the right side of the device can show different-month
screens of Ultrasound calendar/Summary. Note: The screen of
Ultrasound calendar/summary will appear each time when the device
is turned on, or by clicking ON/OFF after the device is on.
After the screen of calendar/summary (Screen 5d), the device will
automatically proceed to the next screen of Ultrasound standby
(Screen 5e). Follow the instruction on this screen to add more
ultrasound gel on the transducer applicator if needed, and click the
ULTRASOUND button to start the Ultrasound function (Screen 5f).
Relax and enjoy the 20 minute treatment of ultrasound provided.
7
Screen 5k
Note: To ensure the patient safety, we implement the maximum temperature
protection of 43º C. When the transducer applicator senses the surface
temperature reaching 43º C., the output of the ultrasound will stop and
automatically resume when it cools down. “Temperature protection” will
display below“ULTRASOUND” (Screen 5k).

QUICK START GUIDE (continued)
Use of Ultrasound function:
Connecting to a Smart Device via Bluetooth (optional)
Note: Bluetooth LE is an optional feature available on specic versions of ManaSport+ for use with compatible smart devices.
For a full list of compatible smart devices, see herein or on our website at www.manamed.com
The ManaSport+ provides a Bluetooth LE wireless option to allow connection to a compatible smart device. The Bluetooth communication is only available to
smart devices using the Manasport+ App. When a Bluetooth connection is established, the Bluetooth connected icon will appear. ManaSport+ can only
communicate to a single device at one time to minimize the risk of unauthorized access. The user interface can also be controlled by a smart phone or tablet
ManaSport+ (app) that must be downloaded from an app store and installed to your personal smart device to operate the ManaSport+ device from a smart phone.
Follow the instructions below to use your ManaSport+ with your personal smart device.
Step 1: Download the ManaSport+ app
To download the app: go to the App Store (Apple) or Google Play
(Android)
for your device and search for“ManaSport+”.
Select download/install.
Notes: All updates will be pushed to the App Store or Google Play.
To update the app, login to the App Store or Google Play, nd the
app, and then click update.
Step 2: Pair the ManaSport+ to your smart device.
You must pair your ManaSport+ controller with your smart device
(smart phone or tablet) before starting a treatment. See App
compatibility section herein for compatible mobile devices.
Bluetooth must be enabled on your smart device in order to
connect to the controller. For Android devices, Location Services
must also be enabled for pairing.
Open the ManaSport+ app and ll out the initial sign in screen. This
allows you to create a login for the ManaSport+ application. You
must enter your rst name, last name, email, and create a password.
If you ever need to reset your password, you can open the app and
click“forgot password”. Reset instructions will go to your email.
Once your prole has been completed, the smartphone will be
ready to pair with the ManaSport+ device, click connect on the app
to pair the device. Once successfully paired, the device is ready to
assist in operating the ManaSport+ device.
Notes:
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automatically every time they are both switched on with Bluetooth
enabled.
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prompt you to retry the process.
Once the controller and the app on your smart device are
successfully paired you may start using your ManaSport+ via the
app versus the buttons the ManaSport+.
8

QUICK START GUIDE (continued)
Use of Ultrasound function via Personal Smart Device: (continued)
Step 3: Power on the ManaSport+ device:
Power on the device via the power button on the ManaSport+ device. Open the ManaSport+ app on your phone. When the app is paired with the device,
a solid Bluetooth symbol will show in the top left corner of the ManaSport+ device. If it is solid, the device is ready for use via the app. Your mobile phone
is ready to control the ManaSport+.
If the Bluetooth symbol is blinking, the app is not connecting to the device. Follow step 2 again.
App Home Screen Overview
Now that you have paired your ManaSport+ app on your smart
device, you a ready to use the ManaSport+ system.
The app home screen allow you to power othe device, unlock the
device, and start the ultrasound stimulation.
When in the home screen, you can press the ultrasound button to
begin your twenty minute treatment. The timer will countdown
from 20 minutes. Once completed, the device will record your
usage and turno.
Note
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alarm, click conrm and then press ultrasound again to begin
treatment.
App Menu Options
If you push the three lines in the top left corner of your device, you
can access the menu portion of the app. In this section, you can
enter other screens of the app. Here is where the app serves as an
educational tool and a usage tool for patients.
This menu includes
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9

QUICK START GUIDE (continued)
Use of Ultrasound function via Personal Smart Device: (continued)
ManaSport+ (Personal Smart Device App) Troubleshooting
ManaSport+ (Personal Smart Device App) Error Messages:
Bluetooth connection
is interrupted
Smartphone Device
Battery Low
Cybersecurity Compliance
10
If during a stimulation treatment the Bluetooth connection signal is disrupted, the stimulation will continue. To stop the
stimulation, grab the device and press the Ultrasound button. Stimulation will be paused and reset back to 20 minutes. In an
emergency situation, you may hold the power button the ManaSport+ device for three seconds for an emergency shut o.
Should your smartphone device issue a battery low alert, the ManaSport+ will continue to function. It would be
recommended to plug in your smartphone device while you nish your treatment.
BLE connection can adopt pairing encryption connection and AES-128 algorithm for encryption. During the pairing
process, the master and slave keep multiple keys: STK, LTK, IRK and CSRK; STK / LTK is mainly used for data encryption
during transmission; Irk is mainly used for device authentication; CSRK is mainly used for message signature and
verication; The use of multiple keys and CRC verication ensure the encryption and accuracy of BLE data transmission. For
more information on the cybersecurity visit our website at www.ManaMed.com.
ManaSport+ App Apple™ Compatibility
Compatible with Apple products (iOS 11 or higher)
iPhone 13 Pro Max
iPhone 13 Mini
iPhone 12 Pro Max
iPhone 12 Mini
iPhone SE (The Second Generation)
iPhone 11 Pro Max
iPhone 11
iPhone XR
iPhone 8 Plus
1iPhone 7
ManaSport+ App Android™ Compatibility
Compatible with Android™
Samsung Galaxy S21
Samsung Galaxy Note 20
Google Pixel 5
Google Pixel 4a
OnePlus 9 Pro
OnePlus 8T
Motorola Edge Plus
Motorola Moto G Power (2021)
LG V60 ThinQ 5G
1TCL 10 Pro

USING THE AC ADAPTER /
BATTERY CHARGER
IMPORTANT: Charge device before rst use.
WARNING: Use only the charger provided by ManaMed™. The use of the wrong charger
can cause excessive heat, damage to the circuit and shorten the life of the battery.
CHARGING: Plug in the power supply adapter to the wall socket using the plug located at
the bottom end of the device. The BATTERY icon on the device will keep ashing or steady,
depending on the state of the charge. When the battery is charging, the BATTERY icon will
keep ashing. Once the battery is fully charged, the BATTERY icon will become solid.
Note: The device cannot be used when it is being charged.
CLEAN AFTER TREATMENT
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the ultrasound head; Wipe and clean the ultrasound gel on the ultrasound head with a blue
cloth or paper towel;
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CLEANING AND MAINTENANCE
UNIT DEVICE: To clean the device, please wipe it with a soft cloth. You can use wipe of
water, alcohol, and mild detergent for cleaning rst, and then use the dry cloth to wipe it again.
TRANDUCER APPLICATOR: After the treatment is completed, wipe the transducer
applicator with a soft cloth or paper towel to remove the ultrasound gel. You can use wipe of
water, alcohol, and mild detergent for cleaning rst, and then use the dry cloth to wipe it again.
Unit must be completely dry prior to use. To ensure that, leave the device in the OFF position
and disconnected from the wall outlet for at least 30 minutes (and as long as necessary for the
unit to dry completely) after cleaning or disinfecting.
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USER MAINTENANCE
Contains no serviceable parts.
Contact ManaMed Customer Service at 888-508-0712.
Inspect the unit and all components for any damage that may have
occurred during shipping or general handling prior to each use (for
example, frayed or cut charging cord, cracked plastic housings, etc).
Refer to image of ManaSport+ for description of all components.
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Avoid subjecting the unit to shocks, such as dropping the device.
Battery is not replaceable; replacement units are available through
customer service.
Contact ManaMed to receive replacements instructions for any
damaged items.
STORAGE
For optimal battery performance, store in a cool, dry,
well-ventilated place.
Store away from sources of heat and direct sunlight.
DISPOSAL
This unit is an electromechanical device that includes printed
circuit boards and rechargeable CBUUFSJFT%POPUEJTDBSEJOMBOEöMM
$POTVMUMPDBMDPVOUZSFRVJSFNFOUT
for proper disposal instructions.
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regular waste. Bring the unit to your local recycle center or contact
ManaMed.
The use of accessories, power supplies and cables other
than those specied, with the exception of components
sold by the manufacturer of the ManaSport+ as
replacement parts, may result in increased emissions or
decreased immunity of the ManaSport+ .
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This unit is an electromechanical device that includes
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not discard in landll. Consult local county
SFRVJSFNFOUTGPSQSPQFSEJTQPTBMJOTUSVDUJPOT
This symbol designates the degree of protection
against electrical shock from the wrap as being a type
B applied part.
Consult instructions for use.
CAUTION: Federal Law restricts this device to sale by
or on the order of a physician.
WARNING: This device is not protected
BHBJOTUXBUFS&RVJQNFOUJTOPUTVJUBCMFGPS
use in the presence of ammable anesthetic
mixture with air, oxygen, or nitrous oxide.
The rechargeable batteries supplied in this
unit are not eld replaceable. If you have
any issues please contact 888-508-0712.for
a replacement unit.
11

Limited Warranty
ManaMed (“Seller”) warrants that the original purchaser (“Purchaser”) of its ManaSport+ purchased by the Purchaser directly from Seller (“Device”)
that the Device conrms to Seller’s manufacturing specications. The warranty will be one year for the date of purchase. In the event of a breach of
this warranty, with a 30-day written notice, Seller will, at its sole option, either repair or replace the Device or issue a refund at the original purchase
price. This warranty is null and void if the Device is resold or a transfer of the Device by Purchaser to any other person or entity. Seller expressly
disclaims any and all other warranties, either expressed or implied, relating to the system or its performance, including, without limitation, any
implied warranty of merchantability and any implied warranty of tness for a particular purpose. This limited warranty does not cover damages due
to eternal causes, including, without limitation, accident, usage not in accordance with product instructions, misuse, neglect, alteration, or repair.
ManaSport+ Expected Shelf Life
The shelf life of ManaSport+ is not applicable because of low likelihood of time-dependent product degradation. Among all the accessories
marketed with ManaSport+, the ultrasound gel may have a certain shelf life, and you can nd the corresponding shelf life or expiration date
on the bottle of ultrasound gel.
ManaSport+ Expected Service Life
The expected service life of ManaSport+ and its accessories is 365 days from the initial treatment. Once ManaSport+ reaches 365 days, it will
provide no further treatment.
ULTRASOUND GEL
Ultrasound gel is provided for use with ManaSport+. Patients are instructed to place gel on the transducer applicator every time you use
ManaSport+. This gel allows the ultrasound signal to reach the depths of the treatment site through your skin. If the transducer applicator is not
properly applied, the patient will receive an alert from the device. For the best result, only use the gel supplied. If you need more gel, please email
ManaMed at [e-mail] or contact your DME supplier. The gel is sourced from Hony Medical Co., Ltd. (Reference Gel #K221999).
Caution: Some patients may experience mild skin irritation to the gel. If you feel your skin is sensitive to the gel, please contact your physician
or use a dierent FDA-cleared ultrasound gel.
Technical Specications
Ultrasound frequency: 1.5 +/- 20% MHz
Ultrasound Duty cycle: 100%
Ultrasound eective radiating area (ERA): 3.9 +/- 20% square cm (cm2)
Ultrasound power: 0.60 +/- 20% watts (W)
Ultrasound spatial average temporal avg. (SATA): 0.16 +/- 20% W/cm2
Ultrasound beam non-uniformity ratio (BNR): 4.0 maximum
Ultrasound beam type: Collimated
Battery: 3.7 VDC Lithium battery
Input Voltage (USB) of battery charger: 5.0 VDC
TECHNICAL DATA
Specications:
Dimensions: 14cm x 5.6cm x 2.4cm
Weight: Approx. 0.13 kg
SYSTEM OPERATING ENVIRONMENT:
Temperature: +10°C (50°F) to +40°C (104°F)
Humidity: 30%-75%. Keep dry.
Source of Power: DC 5 V or Inner Battery (3.7 volt Li-ion
battery)
CAUTION: Charge batteries using only the
power source provided by ManaMed.
POWER SUPPLY:
Class II, input: 100 - 240 Vac, 50 - 60 Hz, output: 5 V @ 1 Amp)
Use only UL/60601-1 approved power supplies from ManaMed for use in hospital settings.
Maximum cable length for the power cable: 1 meter
TOLERANCES:
Output +_20%.
BATTERY CHARGE:
Takes approximately 4 hours
(from depleted state)..
BATTERY RUN TIME:
10 hours
12

Troubleshooting
ManaSport+ will alert you by displaying an alert screen, if something is not working properly. See the following table for common alerts and problems as well as what
to do if you get an alert or problem. If you get any other problem, do not try to x ManaSport+ by yourself and contact customer service at 888-508-0712.
Alert / Problem
Blank screen, and ManaSport+
does not turn on.
The battery area on ManaSport+
or the battery charger gets
excessively warm.
What does this mean?
Contact customer service: ManaSport+ will display
the yellow“Contact manufacturer”screen when
detecting that it is not working properly.
Low battery:
ManaSport+ will display the“Low Battery”screen,
when the battery level is very low.You are not
able to start treatment or view history.
The battery may be completely discharged or the
ManaSport+ device has malfunctioned.
The battery or charger may be malfunctioning.
What should I do?
Call customer service at 888-508-0712.
Do not try to x ManaSport+ by yourself.
You must charge ManaSport+. Plug ManaSport+
into a power source with the provided charger.
Plug ManaSport+ into a power source with the
provided charger and fully charge its battery. If
ManaSport+ still does not respond, contact customer
service at 888-508-0712.
Stop charging ManaSport+ and
contact customer service at 888-508-0712.
Contact Manufacturer
Recharge prior to use
Instructions for reporting adverse events:
MedWatch is the Food and Drug Administration's (FDA) program for reporting serious reactions, product quality problems, therapeutic
inequivalence/failure, and product use errors with human medical products, including drugs, biologic products, medical devices, dietary supplements,
infant formula, and cosmetics. If you think you or someone in your family has experienced a serious reaction to a medical product, you are encouraged to
take the reporting form to your doctor. Your health care provider can provide clinical information based on your medical record that can help FDA evaluate
your report. However, we understand that for a variety of reasons, you may not wish to have the form lled out by your health care provider, or your health
care provider may choose not to complete the form. Your health care provider is not required to report to the FDA. In these situations, you may complete
the Online Reporting Form yourself. You will receive an acknowledgement from FDA when your report is received. Reports are reviewed by FDA sta. You
will be personally contacted only if we need additional information.
Submitting Adverse Event Reports to FDA
Use one of the methods below to submit voluntary adverse event reports to the FDA:
Report Online at www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home.
Consumer Reporting Form FDA 3500B. Follow the instructions on the form to either fax or mail it in for submission. For help lling out the form, see
MedWatchLearn. The form is available at www.fda.gov/downloads/aboutFDA/reportsmanualsforms/forms/ucm349464.pdf. Call FDA at 1-800-FDA-1088
to report by telephone.
Reporting Form FDA 3500 commonly used by health professionals. The form is available at
www.fda.gov/downloads/aboutFDA/reportmanualsforms/forms/ucm163919.pdf.
Summary of ManaSport+ Wireless Functions
The MSPORT02 can be operated manually through the buttons on the device. An optional wireless control unit can be controlled via a Bluetooth App. This
allows the user an alternative way to operate the device wirelessly. Also, the App can access the data and usage of the device. Currently the optional App is not
available. If the optional APP or its update is available, the user may only obtain it from the trusted source instructed by ManaMed. At any time, you can switch
to manually operate the subject device by pressing its buttons to deal with any risks and problems that may arise.
Summary of ManaSport+ Wireless Security Methods
The BLE function of Non-invasive ultrasound device is classied as a device with negligible Cybersecurity Risk. In the process of BLE encrypted data
transmission, STK or LTK is used as the key, AED128 algorithm is used to encrypt the transmitted data, and then 32bit message integrity verication and 24bit
CRC verication are included. The receiver uses the same key for verication and decryption to ensure the integrity and accuracy of the data. Non-invasive
ultrasound device also complies with the BLE 4.2 protocol, and its data integrity is validated during transmission.
Radio Frequency Wireless Information
Radio Frequency Wireless technology is used in the ManaSport+ for communication between an optional phone app and the ultrasound device.
13

Radio Frequency Wireless Description
Wireless Protocol Characteristics
Operation Frequency 2.4 GHz ISM
Protocol Type Frequency Hopping
Bluetooth Version: V4.2
Frequency modulation GFSK
Frequency deviation ± -320 kHz
EIRP Measured max -6.2 dBM (0 dBM congured as maximum output power
Eective emission power 4.4 [dBm]
Data rate 2 Mbps
Number of Channel: 40
Channel width 2 MHz
Antenna Type: PCB Antenna
Antenna Gain 0dBi
Hardware Version: V1.0
Software Version: V1.1
Wireless QoS: Transfer Rate > 0.5kbps, Packet Error Rate < 10%, Transfer Completion < 1S
Communication: Wireless 2.4GHz(BLE mode)
Transmission Range: Up to 10 meters
Data Storage: Transferred data is received and temporarily saved in the connected mobile terminal.
Waterproof Rating IPX2
Quality of service requirement 2 meter range between app on phone and stimulation modules
Wireless Security Method
Device identication 32 bits, shared only with other ManaSport+ devices
Data integrity checks Each data frame protected by a 24 [b] length CRC
Acknowledgement Each point-to-point communication is acknowledged
Coexistence with other ManaSport+ Devices
Each Smartphone App control and module is assigned a unique ID.
Designed for coexistence with - Bluetooth (IEEE 802.15.1) - Wi-Fi (IEEE 802.11)
wireless products in the same RF band.
Utilizes established coexistence - FDMA (Frequency Division Multiple Access) - -TDMA (Time Division Multiple Access)
principles to minimize cross-talk with
other wireless devices.
Out of range behavior The MSPORT02 can still be operated independently if the control on the smartphone is suddenly interrupted, without any
impact on the MSPORT02 functions.
*OUFSGFSFODFGSPNPUIFSEFWJDFT t#MVFUPPUI-&XJSFMFTTUFDIOPMPHZJODMVEFTBEBQUJWFGSFRVFODZIPQQJOHBOEXJMMBVUPNBUJDBMMZSFBUUFNQUBDPOOFDUJPOJGUIFDPOOFDUJPOGBJMT
 t*OUFSGFSFODFGSPNPUIFS3'XJSFMFTTBOENPCJMFDPNNVOJDBUJPOEFWJDFTJTQPTTJCMF3FGFSUP&.$5BCMFTGPSSFDPNNFOEFEEJTUBODFTCFUXFFO
ManaSport+ and other RF devices.
t8IFOVTFEJOBSFTJEFOUJBMFOWJSPONFOUGPSXIJDI$*413DMBTT#JTOPSNBMMZSFRVJSFEUIJTQSPEVDUNJHIUOPUPòFSBEFRVBUFQSPUFDUJPOGPS
radio-frequency communication services. The user might need to take mitigation measures, such as moving the product to another location or
remove possible sources of interference.
The smartphone is only auxiliary control MSPORT02 and synchronous view of MSPORT02 usage data, these functions can be completed
independently by MSPORT02. The MSPORT02 can still be operated independently if the control on the smartphone is suddenly interrupted,
without any impact on the MSPORT02's work. Moreover, all the usage data is stored in the MSPORT02 body instead of the mobile APP, and
the App needs to synchronize the usage data form MSPORT02 every time it connects.
In the unlikely event of wireless function failure, the user is aware of the interrupted connection via the App interface, and the user has the option
of attempting to reconnect to the receiver (e.g., smart phone or tablet), if needed. If Bluetooth is unavailable for any reason or excessively
delayed, no harm will come as the collected data can be reacquired if needed.
Based on the intended use of MSPORT02, the App should command MSPORT02 correctly and can synchronize
to the correct usage data. The QoS PASS/FAIL criteria was dened as follows: Transfer Rate > 0.5kbps,
Packet Error Rate < 10%, Transfer Completion < 1S
14
List the eects of delayed/failed
communication of each wireless
function.
In the event of a wireless function
failure, how is the device designed
to fail safely?
A brief description of the wireless
QoS needed for a safe and eective
operation of the device.

ELECTROMAGNETIC COMPATIBILITY (EMC)
TABLES - RF EMISSIONS CLASS B
GUIDANCE AND MANUFACTURER’S DECLARATION - ELECTROMAGNETIC EMISSIONS
The ManaSport+ is intended for use in the electromagnetic environment specied below.
The customer or the user of the ManaSport+ should assure that it is used in such an environment.
RF Emissions CISPR11
Harmonic Emissions IEC
61000-3-2
Voltage Fluctuations IEC
61000-3-3
RF Emissions CISPR11
Class B
Class A
Complies
Group 1
ManaSport+ 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.
ManaSport+ 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.
Emissions Tests Compliance Electromagnetic Environment Guidance
GUIDANCE AND MANUFACTURER’S DECLARATION - ELECTROMAGNETIC IMMUNITY
The ManaSport+ is intended for use in the electromagnetic environment specied below.
The customer or the user of the ManaSport+ should assure that it is used in such an environment.
Electrostatic
Discharge (ESD)
IEC 61000-4-2
Electrical Fast
Transient/Burst
IEC61000-4-4
Surge
IEC61000-4-5
±1kV dierential
mode
±2kV common mode
±1kV dierential
mode
±2kV common mode
Mains power quality should be that of a typical commercial or hospital environment.
Mains power quality should be that of a typical commercial or hospital environment. If the user of the
ManaSport+ requires continued operation during power mains interruptions, it is recommended that the
ManaSport+ be powered from an uninterrupted power supply or a battery.
Voltage
dips, short
interruptions
and voltage
variations on
power supply
input lines
IEC61000-4-11
Power Frequency
(50/60Hz)
Magnetic Fields
IEC61000-4-8
30 A/m at
50 or 60 Hz
30 A/m at
50 or 60 Hz
Power frequency magnetic elds should be at levels characteristic
of a typical location in a typical commercial or hospital environment.
<5%U
T
(>95% dip in U
T
)
for 0.5 cycle
40%U
T
(60% dip in U
T
)
for 5 cycles
70%U
T
(30% dip in U
T
)
for 25 cycles
<5%U
T
(>95% dip in U
T
)
for 5 seconds
NOTE: U
T
is the a.c mains voltage prior to application of the test level.
<5%U
T
(>95% dip in U
T
)
for 0.5 cycle
40%U
T
(60% dip in U
T
)
for 5 cycles
70%U
T
(30% dip in U
T
)
for 25 cycles
<5%U
T
(>95% dip in U
T
)
for 5 seconds
±2kV for power
supply lines
±1kV for input/
output lines
±2kV for power
supply lines
±1kV for input/
output lines
Mains power quality should be that of a typical commercial or hospital environment.
Floors should be wood, concrete or ceramic tile. If oors are covered with synthetic material,
the relative humidity should be at least 30%.
±8kV contact
±15kV air
±8kV contact
±15kV air
Immunity
Test
IEC 60601 Test
Level
Compliance
Level Electromagnetic Environment Guidance
The ManaSport+ is a portable and rechargeable prescriptive device.
Warning: Don’t use near active HF surgical equipment and the RF shielded room of an ME system for magnetic resonance imaging, where the intensity of EM
disturbances is high.
Warning: Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is
necessary, this equipment and the other equipment should be observed to verify that they are operating normally.
Warning: Use of accessories, transducers, and cables other than those specied or provided by the manufacturer of this equipment could result in increased
electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.
Warning: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 12 in (30 cm)
to any part of the equipment, including cables specied by the manufacturer. Otherwise, degradation of the performance of this equipment could result.
Technical description:
1. All necessary instructions for maintaining BASIC SAFETY and ESSENTIAL PERFORMANCE with regard to electromagnetic disturbances for the excepted service life.
2. Guidance and manufacturer’s declaration-electromagnetic emissions and Immunity.
15

ELECTROMAGNETIC COMPATIBILITY (EMC)
TABLES - RF EMISSIONS CLASS B (continued)
GUIDANCE AND MANUFACTURER’S DECLARATION - ELECTROMAGNETIC IMMUNITY
RECOMMENDED SEPARATION DISTANCE BETWEEN PORTABLE AND MOBILE RF COMMUNICATIONS EQUIPMENT AND
THE MANASPORT+
The ManaSport+ is intended for use in the electromagnetic environment specied below.
The customer or the user of the ManaSport+ should assure that it is used in such an environment.
Conducted RF
IEC61000-4-6
Portable and mobile RF communications equipment should be used no closer to any part of the ManaSport+,
including cables, than the recommended separation distance calculated from the equation applicable
to the frequency of the transmitter.
Recommended separation distance
150 KHz to 80 MHz
80 MHz to 800 MHz
800 MHz to 2.5 GHz
Radiated RF
IEC61000-4-3
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 aected by absorption and reection from structures, objects and people.
The ManaSport+ is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the ManaSport+ can help
prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the ManaSport+ as
recommended below, according to the maximum output power of the communications equipment.
Separation distance according to frequency of transmitter
m
Rated maximum output
power of transmitter
W
0.01
0.1
1
10
100
0.12
0.38
1.2
3.8
12
0.12
0.38
1.2
3.8
12
0.23
0.73
2.3
7.3
23
150 KHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
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 the xed RF transmitters, an electromagnetic site survey should
be considered. If the measured eld strength in the location in which the ManaSport+ is used exceeds the applicable RF compliance level above, the ManaSport+ should be
observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the ManaSport+.
b Over the frequency range 150 kHz to 80 MHz, eld strengths should be less than [V1] V/m.
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 aected by absorption and reection from structures, objects and people.
For transmitters rated at a maximum output power not listed above, the recommended separation distance 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.
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 xed 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:
3 V/m
80 MHz to 2.5
GHz
10 V/m
3Vrms
150 kHz to 80
MHz
3Vrms
Immunity
Test IEC 60601 Test Level Compliance Level Electromagnetic Environment Guidance
d = 1.2 √P
d = .35 √P
d = .70 √P
d = 1.2 √P d = .35 √P d = .70 √P
16

The ManaSport+ complies with current medical standards.
The ManaSport+ also complies with the IEC 60601-1 standard on general safety requirements for electro-medical devices, the IEC 60601-1-2 standard
on electromagnetic compatibility, the IEC 60601-2-5 standard on basic safety and essential performance of ultrasonic physiotherapy equipment, IEC
61689 eld specications and methods of measurement in the frequency range 0.5 MHz to 5 MHz, IEC 60601-1-6 General requirements for basic
safety and essential performance - Collateral standard: Usability, and the IEC 60601-1-11 standard for use in the home environment.
The ManaSport+ also complies with the ISO 10993-5 Biological evaluation of medical devices – Part 5: Tests for In Vitro Cytotoxicity, ISO
10993-10 Biological evaluation of medical devices - Part 10: Tests for Irritation and Skin Sensitization.
The ManaSport+ also complies with AAMI TIR69:2017, ANSI C63.27-2017, AAMI TIR 18-2010.
Standards
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.
Caution: The user is cautioned that changes or modications not expressly approved by the party responsible for compliance could void the
user’s authority to operate the equipment.
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 oand on, the user is encouraged to
try to correct the interference by one or more of the following measures:
a) Reorient or relocate the receiving antenna
b) Increase the separation between the equipment and receiver
c) Connect the equipment into an outlet on a circuit dierent from that to which the receiver is connected.
d) Consult the dealer or an experienced radio/TV technician for help.
FCC Radiation Exposure Statement: This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment.
This transmitter must not be co-located or operating in conjunction with any other antenna or transmitter.
FCC Statement
17