Med-Fit Pro User manual

lease read this User Manual before using your Ultrasound
Tel: [phone] www.tensmachineuk.com email: [e-mail]
Med-Fit®ro Therapeutic
Rechargeable 1MHz Ultrasound
User Manual and Treatment Guidelines
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Med-Fit UK Ltd.
Unit 8 Martel Court, S. Park Business Park, Hamilton Road, Stockport, SK1 2AF
Tel: [phone] | Tel: [phone] | Fax: [phone]
mail: sal[email protected] | www.tensmachineuk.com
Company registration number 08758741 | Vat registration number 308 286 105
Supplied with the following Accessories
• 1x Ultrasound Unit - ULS101
• 1x 250ml Ultrasound Gel - ULS600
• 1x Power Adaptor - ULS800
• 1x Carry Case
• 1x User Manual
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Contents
INTRODUCTION 4
RECAUTIONARY INSTRUCTIONS 5
IM ORTANT SAFETY RECAUTIONS AND WARNINGS 6
DIS OSAL 9
GLOSSARY OF SYMBOLS 9
INGRESS ROTECTION (I ) RATING 9
TROUBLESHOOTING 10
CLEANING AND STORAGE 10
S ECIFICATIONS 11
INDICATIONS 12
CONTRAINDICATIONS 13
REVENTING ADVERSE EFFECTS OF ULTRASOUND 14
TECHNIQUES OF A LICATIONS ( LEASE READ THIS SECTION BEFORE USE) 15
MED-FIT RO ULTRASOUND FUNCTIONS & CONTROLS 17
ULTRASOUND TREATMENT SETTINGS 17
DIS LAY FUNCTIONS AND FEATURES 18
CHARGING YOUR ULTRASOUND 19
STE BY STE GUIDE 20
CHARGING INDICATOR GUIDELINES 22
WARRANTY 23
IM ORTANT INFORMATION REGARDING ELECTRO 24
MAGNETIC COM ATIBILITY (EMC)
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INTRODUCTION
Welcome to the Med-Fit® Pro Ultrasound therapy device, designed and manufactured
using advanced digital signal processing. The result is a unit with excellent versatility based
on simplicity of operation.
This manual has been written for the owners and operators of the Med-Fit® Pro
Ultrasound. It contains general instructions for operation, precautionary instructions and
maintenance recommendations. In order to obtain maximum life and efficiency from your
Med-Fit® Pro Ultrasound and to assist in the proper operation of the unit, read and
understand this manual thoroughly and become familiar with the controls on the panel as
well as the accessories that come with the unit before operation of the unit.
The specifications put forth in this manual were in effect at the time of publication.
Before administering any treatment to yourself or a patient please read this user manual
and operating instructions within the manual. Please read all precautionary instructions
listed below.
recautionary Instructions
CAUTION: Read, understand and practice the precautionary and operating instructions.
Know the limitations and hazards associated with using any ultrasound device.
Observe the precautionary and operational decals placed on the unit.
CAUTION: The Ultrasound should be routinely checked before each use to determine that
all controls function normally, especially that the intensity settings properly
adjust.
WARNING: This device should be kept out of the reach of children.
CAUTION: Meets I C/ N 60601-1-2 lectromagnetic Compatibility/Interference safety
standard. (Care must be taken when operating this equipment around other
equipment. Potential electromagnetic or other interference could occur to this
or to the other equipment. Try to minimize this interference by not using other
equipment in conjunction with it.)
WARNING: Type BF quipment
CAUTION: This unit should be operated, transported and stored in temperatures between
15˚C -40˚C, with relative humidity ranging from 30%-60%
ATT NTION: Consult accompanying documents.
LIABILITY DISCLAIMER
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IM ORTANT SAFETY RECAUTIONS AND
WARNINGS
It is important that you read all the warning and precautions included in this
manual because they are intended to keep your safe, prevent injury and avoid a
situation that could result in damage to the device.
SAF TY SYMBOLS US D IN THIS MANUAL
DANG R Indicates a potentially hazardous situation which, if not avoided,
could result in death or serious injury.
WARNING Indicates a potentially hazardous situation which, if not avoided, could
result in serious injury and equipment damage.
CAUTION Indicates a potentially hazardous situation which, if not avoided, may
result in minor or moderate injury to the user or patient or damage to
the device or other property.
DANG R
• This device must not be used in combination with the following medical devices:
• Internally transplanted electronic medical devices, such as a pacemaker.
• lectronic life support equipment, such as respirators.
• lectronic medical devices attached to the body, such as electrocardiographs. Using
this device with other electronic medical devices may cause erroneous operation of
those devices.
WARNING
DO NOT USE THE DEVICE IN THESE CONDITIONS
• If you have a cardiac pacemaker, implanted defibrillator, or other implanted metallic
or electronic device. Such use could cause electric shock, burns, electrical
interference, or death.
• Together with a life‐supporting medical electronic device such as an artificial heart or
lung or respirator.
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• In the presence of electronic monitoring equipment (e.g., cardiacmonitors, CG
alarms), which may not operate properly when the device is in use.
• Microwave radiation can disrupt the device. The device should not be used in close
proximity of equipment emitting microwave radiation.
• lectromagnetic energy can disrupt the device. The device should not be used in close
proximity of equipment emitting electromagnetic energy.
• quipment emitting RF can disrupt the device. The device should not be used in close
proximity of equipment emitting RF waves e.g. mobile phones etc.
• The device should not be used in presence of high frequency devices (shortwave or
therapy) systems.
• On open wounds or rashes, or over swollen, red, infected, or inflamed areas or skin
eruptions (e.g., phlebitis, thrombophlebitis, varicose veins);or ontop of,or in proximity
to, cancerous lesions.
DO NOT USE ON THESE INDIVIDUALS
• The device is for single paitient use only
• During pregnancy or menses.
• Have allergic dermatitis or hemorrhage.
• Have telangiectasia or disordered liver function caused by long tern uptake of steroid
and hormone.
• Over areas of skin that lack normal sensation.
• Children or infants, because the device has not been evaluated for pediatric use.
• Persons incapable of expressing their thoughts or intentions.
• Do not use over eyes, head reproductive organs, head or open wounds.
DO NOT USE ON THESE AREAS
• Do not apply the device over painful areas. If you have painful areas, you should
consult with your physician before using this device;
• Do not apply the device over open wounds or rashes, or over swollen, red, infected, or
inflamed areas or skin eruptions (e.g., phlebitis, thrombophlebitis, varicose veins);
• Do not apply the device over, or in proximity to, cancerous lesions;
Telephone: [phone] www.tensmachineuk.com
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DO NOT USE THIS DEVICE DURING THESE ACTIVITIES
• When in the bath or shower;
• While sleeping;
• While driving, operating machinery, or during any activity in which the device can put
you at risk for injury.
• Keep the device out of the reach of young children.
• If you are in the care of a physician, consult with your physician before using this
device.
CAUTION
• If the device is not functioning properly or you feel discomfort, immediately stop using
the device.
• Do not use for any other purpose except for what it is intended for.
• Do not use the device while wearing electronic devices such as watches as this may
damage the device.
• Dispose of the device, and components according to applicable legal regulations.
Unlawful disposal may cause environmental pollution.
• You may experience skin irritation or hypersensitivity due to the conductive medium
(gel).
• If you have suspected or diagnosed heart disease, you should follow precautions
recommended by your physician; and
• If you have suspected or diagnosed epilepsy, you should follow precautions
recommended by your physician.
• You should stop using the device and consult with your physician if you experience
adverse reactions from the device.
• Dispose of the device, batteries, and components according to applicable legal
regulations. Unlawful disposal may cause environmental pollution.
• Use caution if you have a tendency to bleed internally, such as following an injury or
fracture;
• Consult with your physician prior to using the device after a recent surgical
procedure, because stimulation may disrupt the healing process;
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DIS OSAL
Used fully discharged batteries must be disposed of in a specially
labeled collection container, at toxic waste collection points or through
an electrical retailer. You are under legal obligation to dispose of
batteries correctly.
Please dispose of the device inaccordance with the legal obligation.
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GLOSSARY OF SYMBOLS
lectrical devices are recycle label material and should not be disposed
of with house hold waste after their useful life! Help us to protect the
environment and save resources and take this device to the appropriate
collection points. Please contact the organization which is responsible
for waste disposal in your area if you have any questions.
Type BF equipment
Refer to instruction manual
Do not use with a pace maker
C certified device
The a AC DC adaptor is for indoor use only and should only be used
with this device.
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Note: IP rating mentioned on the datasheet is confirmed by our company in accordance with the following test method defined in the standard.
Please check the Sealability in advance under the actual environment and application condition.
Specification of IP69K
IP69K is a protection provision of high temperatured and pressured water which prescribed by Germany standard DIN 40050
PART9.
The test specifies a spray nozzle that is fed with 80°C water at 80 to 100 bar and a flow rate of 14 to 16 L/min. The nozzle is held
10 to 15 cm from the tested device at angles of 0°, 40°, 60° and 90° for 30 s each. The test device sits on a turntable that rotates.
Note: Connected part doesn't satisfy the Degree of protection mentioned in the Ratings/Characteristics in case that the wiring is
not normally done, connector does not have the protection performance or e-CON connector is used.
I E C (Inter national Electrotechnical Commission) Standard (IEC6 0529: 2001)
IP-
Protection specification code (International Protection)
"First Digit" Protection against solid object
Code Level of protection
0No protection
1Ingress of solid object diameter
50 mm is protected
2Ingress of solid object diameter
12.5 mm is protected
3Ingress of solid object diameter
2.5 mm is totally protected
4Ingress of solid object diameter
1.0 mm is totally protected
5Protected against harmful dust
6Totally protected against dust
φ50 mm
φ12.5 mm
2.5 mm
1mm
*1. Our company Test Method
IP67 for proximity sensor:
In addition to the following test, heat shock cycle test (0°C cold water
for 1 hour, 70°C hot water for 1 hour) is conducted repeatedly for 5
times, confirming no CR and detection distance problem
*2. Note for our test outline
Proximity sensor E2F term of use: inside water in 10 m depth, in
natural condition.
1)sink into 2 atm of water for 1 hour, no water ingress
2) repeat the heatshock cycle for 20 times, confirming no CR and
detection distance problem
"Second Digit" Protection against liquid object
)retawerupgnisudemrofreptset(eniltuodohtemtseTnoitcetorpfoleveLedoC
0No protection no protection against liquid object Notest
1
Protection against water drop
No harmful effect of vertical water drip By using water drip tool vertically
dropping water for 10 min
2
Protection against water drop No harmful effect of water drip from
vertical direction when the enclosure is
tilted at 15° from its normal position
By using water drip tool, move it in angle
of 15°, dripping water for 10 min (2.5 min
per direction)
3
Protection against water spray
No harmful effect of water spray at any
angle up to 60° from the vertical direction
By usin g t o ol as descrip ted in right pictu re,
spraying water vertically in angle up to
60° for 10 min
4
Protection from water splash
No harmful effect of water spray from all
direction
By usin g t o ol as descrip ted in right pictu re,
splashing water from all direction for
10 min
5
Protection from water jets
No harmful effect of water splash from all
direction
By usin g tool as descrip ted in right pictu r e,
Jet the water from all direction to the
object surface for 1 m2/min, at least for
3min in total.
6
Protection from str ong water jets
No harmful e f f e c t of strong water jets f r o m
all direction
By usi ng tool as desc ribed in ri g ht picture,
Jet the water from all direction to the
object surface for 1 m2/min, at least for
3min in total.
7
Protection from water dip
No harmful effect of water dip in certain
level of pressure and length of time Dip into 1 m depth water for 30 min
8
Protection from water sink No harmful effect against water sink
which the condition is decided between
customer & manufacturer (in severer
condition comparing to no.7)
Should be decided between customer and manufacturer
200 mm
200 mm
15°
Water volume per
each hole: 0.07 l/min
Water volume per
each hole: 0.07 l/min
2.5 to 3 m
12.5 l/min
Diameter of discharging nozzle: φ6.3
2.5 to 3 m
Diameter of discharging nozzle: φ12.5
100 l/min
*1
1 m
*2
Internal standard of oil endurance
Note: We use standardized oil for the above test.
(Equivalent to former JEM standard [Standards of the Japan
Electrical Manufacturers' Association])
Level of protection
Prevention Protected against oil dripping and splashing from all
direction
Endurance Internal part is protected against oil dripping and
splashing from all direction
10 to 15 cm
90°
60°
30°
0°
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INGRESS ROTECTION (I ) RATING
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TROUBLESHOOTING
NOTE: If the following measures fail to alleviate the problem, please call your authorized
agency or supplier.
CLEANING AND STORAGE
roblem ossible causes ossible solution Display
Charging fail Poor contact between Reinsert the plug into the Battery indicator
the socket and the plug socket, make sure good Not flashing whilst on
contact between them. Charge
Circuit fault Contact authorised LCD display shows
agency or supplier blank screen
No output or output Battery exhausted Recharge the battery. Blank display
instability Circuit fault Contact authorised Start/Pause button
agency or supplier no operation
Liquid get into the Poor sealed Contact service NA
detector agent for repair
The device gets hot Circuit fault Contact service NA
during charging agent for repair
These generalised cleaning instructions are indicated for use with Med-Fit Pro Ultrasound.
Cleaning is defined as the removal of all visible soil or contaminants from the transducer.
All transducers must be cleaned after every use.
1) Turn unit off.
2) Use a moistened soft cloth or wipe to remove any remaining contaminates that remain
on the transducer or cable, do not re-use cloths or wipes. Soap detergents or
enzymatic cleaners should be used in accordance with the manufactures instruction.
NOT : The sound head must be cleaned between each therapy session.
3) To clean the accessories, use only soap and water. Alcohol may be used to disinfect the
aluminum surface, but avoid the plastic area. The Med-Fit Pro Ultrasound case may be
cleaned by wiping with a damp cloth or mild cleaning solution. Avoid abrasive
cleansers. Note: This device and accessories does not require sterilization.
Storing the unit - Place the unit, adapter and manual back in the case. Store the case in a
cool, dry place, 20~55; 10% ~90% relative humidity.
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S ECIFICATIONS
General Information
Power supply: DC 3.7V
Adaptor: Input: 100 to 240 Volts AC,50/60Hz Output:DC5V,1A
Safety class: Class, type BF applied part (according to I C60601-1)
Weight of unit body: 220g
Dimensions: 170mm*46 mm* 50mm(W*H*D)
The ssential Performance of the device is free from the production of unwanted or
excessive ultrasound energy output.
Environment conditions for transport and storage
nvironment temperature: -20° till +55° C
Relative humidity: 10 till 90 % (not condensing)
Atmospheric pressure: 700 till 1060 hPa
Environments conditions for normal use
nvironment temperature: 5° till 40° C
Relative humidity: 10 till 90 %
Technical data of Ultrasonic
Acoustic Frequency: 1MHz ± 10%
Output Intensity: 0.75W/ cm2(Max.)
Ptm: 1.5W
Pulse repetition rate: 145Hz 170Hz 200Hz
Duty factor: 18% 21% 25%
ffective radiating area (A R): 4cm2± 10%
BNR (Max.): 8.0
Beam type: Convergent
Waveform: pulsed
Treatment time: 10min
Material of treatment head: Stainless steel
Shenzhen Goodwind Technology Development CO., LTD. Declares that the device complies
with following normative documents:
I C60601‐1, I C60601‐1‐2, I C60601‐2‐5, I C61689, I C62366, I C60601‐1‐11，ISO10993‐5,
ISO10993‐10, ISO10993‐1,ISO15223
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Ultrasound for use in applying deep heat can be used for treatment of selected medical
conditions such as minor aches and pains, it can help the reduction of pain and
improvement of blood flow in the indications listed below. Those conditions may be
associated with adhesive capsulitis, bursitis with slight calcification, myositis and soft
tissue injuries.
Indications for use
1. Soft tissue injuries
2. Chronic connective tissue and joint dysfunction
3. Osteoarthritis
4. Periarthritis
5. Bursitis
6. Tenosynovitis
7. Tendonitis, bursitis, capsulitis
8. Chronic sprains / strains
9. Muscle spasm
Warnings
Always keep the applicator sound head in constant motion.
Always keep the sound head in full contact with the patient’s skin when setting intensity.
Use ample conductive gel to ensure good coupling throughout the treatment. If needed,
apply when setting intensity. The gel supplied with the unit is ISO10993 certified.
Be sure to read all instructions before treating yourself or patient.
Do not drop the sound head on hard surfaces.
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INDICATIONS
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CONTRAINDICATIONS
Ultrasound should not be used over:
An area of the body where a malignancy is known to be present.
• The eyes
• The reproductive organs
• An acute infection or sepsis
• A pregnant uterus
• A deep vein thrombosis
• An arterial disease
• An anesthetized area or condition that causes impairment of sensation, such as
chemotherapy.
• Not to be used on any person under the age of 16 without medical supervisions.
• The chest area if the patient is using a cardiac pacemaker.
A healing fracture
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.
Patients with an implanted neurostimulation device must not be treated with or be in close
proximity to the ultrasound device..
recautions
Precautions should be taken when used:
• For acute conditions of inflammation and tendinitis that can be exacerbated by the use of
ultrasound.
• Over an area of the spinal cord following a laminectomy.
• On patients with a tendency toward haemorrhaging.
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Applicator Movement
If movement of the ultrasound applicator is too slow, the patient may feel perosteal pain
characterized by a deep ache or pain. If motion is too fast, or if the applicator head does not
maintain good contact with the skin, the therapeutic effect of the sound waves will be
reduced and the sound head may overheat.
atient Susceptibility
Some patients are more sensitive to ultrasound output and may experience a reaction
similar to a heat rash. Be sure to inspect the treatment area during and following
treatment, and discontinue if an adverse reaction does occur.
Output ower
Choose a lower watt setting to reduce output or select a pulsed duty cycle. Higher output
levels have a greater potential for patient discomfort.
Coupling
Coupling is described as contact between the sound head and the treatment site and may
be accomplished through the use of a coupling agent, such as gel, lotion or Polar Frost gel.
Anything used as a coupling agent must be highly conductive. Air is a very poor conductor
of ultrasonic waves.
Safety Considerations for the Ultrasound Head
The crystal within the ultrasound head will only perform predictably and safely if it is not
mishandled by the operator. If the soundhead is dropped, the manufacturer should be
called to determine if the crystal has been damaged (possibly changing its output).
It is also essential that the ultrasound intensity N V R be turned up before the soundhead
is against a medium that will conduct the soundwaves. When the intensity is turned up
without a transmission couplant, the soundwaves bounce back into the crystal, heating the
head and risking the integrity of the crystal.
REVENTING ADVERSE EFFECTS
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TECHNIQUES OF A LICATION
Treatment area
The skin should be clean and dry before applying the coupling gel. The treatment area
should be no more than twice the size of ultrasound transducer head.
Transmission media (couplant)
The higher the water conductive medium, the less the ultrasound energy is absorbed by
the medium and the more energy is available to produce thermal effect. Less efficient
mediums heat up, resulting in surface warmth to patient. In order of efficiency:
1. Water
2. Aqueous gel (conducts 96% of sound)
3. “Hydro” gel, (brand x), 68% of sound conducted
4. Mineral oil
5. Coupling lotion
Treatment time
Treatment time is generally between 5 and 10 minutes.
Never treat over 15 minutes regardless of treatment area.
Frequency of treatment
Acute conditions may be treated using low intensity ultrasound once or even twice daily for
6 to 8 days until acute symptoms such as pain and swelling subside. In chronic conditions,
treatment may be done on alternating days. Ultrasound treatment should continue as long
as there is improvement. If no improvement is noted following three or four treatments,
ultrasound should be discontinued, or different parameters (i.e., duty cycle, frequency)
employed. Typically recommended treatment times are between 5 and 10 minutes.
Ultrasound treatments are similar to exercise session in that each session builds on the
previous one. For most conditions and whenever possible, daily ultrasound treatments will
provide the most benefits to the patient.
Ultrasound Sensation and Tolerance
It is important to remember that everyone’s tolerance to ultrasound is different, and
therefore the intensity should always be adjusted to the correct level. You should not feel
warmth during the treatment as ultrasound is absorbed deep inside the tissues and
surrounding underlying structures. If the transducer feels hot at the skin surface, it is
likely that the coupling medium is inadequate. If you feel a deep aching sensation during
the treatment, stop immediately. Periosteal burns may feel like a deep ache while the
ultrasound is still on, and only later in the day will feel intensely painful.
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TECHNIQUES OF A LICATION
The Med-Fit Pro Home Ultrasound now
features the auto-pulsed mode
Low setting zone bar setting, automatically sets a pulsed mode. This is ideal for acute
conditions where low intensity is required.
Medium settings z
z two bar setting, automatically sets the pulse mode, this is a longer
pulsed mode, ideal for more sub-acute conditions.
High settings z
z z three bar setting, automatically sets a pulsed mode. Ideal for chronic
conditions or treating larger muscle groups for example quadriceps hamstrings and deep-
seated muscles with long standing injuries.
Methods of Soundwave Transmission
Direct Contact- When using the direct technique, the ultrasound head is put against the
skin with only a thin layer of couplant (gel or lotion) in between. Considerations when
using this technique are the amount of soft tissue over the bone in that area.
Treatment time: 5 – 10 minutes Penetration: 4 – 6 cm
1. Apply a generous amount of coupling medium to clean dry skin
2. Move transducer in either a circular or stroking pattern
3. Turn intensity up to treatment level
4. ach circle / stroke should overlap the previous by ½
5. Treatment area limited to 2 times size of transducer
6. Slow and deliberate (moving the soundhead approximately 4 cm per second)
7. Transducer must stay in contact and in motion to avoid overheating of the transducer
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Transducer Head
Liquid Crystal Display
Start/Pause button
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FUNCTIONS AND CONTROLS
Acute Level 1 z
Sub Acute Level 2 z z
Chronic Level 3 z z z
ulsed R 145Hz
ulsed R 170Hz
ulsed R 200Hz
Intensity Settings
Acute Level 1 z
Sub Acute Level 2 z z
Chronic Level 3 z z z
Ultrasound Output Indicator
Charging Port
On/Off button
Intensity button
ULTRASOUND TREATMENT SETTINGS
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DIS LAY FUNCTIONS AND FEATURES
A. The ultrasound frequency is displayed once the intensity level is set
B. Intensity level has three settings
Level 1 z(One Bar)
Level 2 z
z (Two Bars)
Level 3 z
z z (Three Bars)
C. Battery Indicator
One Bar 25% charge
Two Bars 50% charge
Three Bars 100% charge
D. Ultrasound output indicator
The ultrasound output indicator will flash on and off, when the ultrasound start button is
pressed and ultrasound is being transmitted
1MHz
10:00
SONIC
A. Ultrasound Frequency
B. Intensity Level Settings
. Countdown Timer
This is not adjustable
D. Ultrasound Output
Indicator
C. Battery Indicator
SONIC
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DIS LAY FUNCTIONS AND FEATURES
E. Countdown timer
The first you switch on the ultrasound the timer display is set at 00:00 pressing the
intensity level button automatically sets the timer at 10:00 minutes this is not adjustable
and will countdown once the start button is pressed.
You may pause the treatment at any time by pressing the start/pause button. To re-start the
treatment simply press the button again.
CHARGING YOUR ULTRASOUND
Your ultrasound is supplied with
1 x charging Adaptor
Plug directly into the probe and connect to any mains outlet
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Be ore using the ultrasound device please ully charge the ultrasound as
described on pages 19 and 22.
We always recommend that a small amount o ultrasound coupling gel is
now placed onto the transducer head be ore switching on the device.
(smear over the complete sur ace o the transducer head).
Press the
On/O button
once (Fig 1)
For the correct intensity
level please re er to
page 15-16 (Techniques
o application)
Once you have the desired ultrasound settings, place more ultrasound gel
on the transducer head and urther gel on to the area o the body to be
treated. (Please ollow the guidelines laid out in this manual, techniques o
application see page 15).
Press the start button the word sonic will start
to lash and the counter will start to count
down. A green light on the back indicates the
unit is transmitting correctly (Fig 3)
At the end o each treatment session wipe the transducer head clean with
a damp so t cloth or tissue.
STE BY STE GUIDE
00:00
SONIC
1MHz
10:00
SONIC
1MHz
10:00
SONIC
Press level button, to
the required intensity
settings (Fig 2)
Fig1 Fig2
Fig3
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