Revitive UT1033 User manual

Model number: UT1033
PLEASE READ THE USER’S
MANUAL CAREFULLY BEFORE
USING THIS PRODUCT
USE ONLY AS DIRECTED
If symptoms persist, consult
your healthcare professional
User’s Manual
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23
Contents
What is inside the box? 4
Parts and Controls 5
Indications for use 6
Important Safeguards 7-8
Contraindications 7
Warnings and Cautions 8
Instructions for use 9-16
How to use REVITIVE Ultrasound 9-11
Therapy Application Table 12-13
Treatment Head Test 14-15
How to use the Ultrasound Gel
15
Cleaning Recommendations 16
Storage
16
Troubleshooting
17
Symbols 18-19
Technical Specifications 20-21
Warranty 22
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45
Connection Port
15
10
5
15
10
5
Treatment Head
15
10
5
15
10
5
Time Indicators (x3)
Time Button
Mode Indicators (x3)
Mode Button
Power Indicator
Power Button
On opening the carton, please check that the following components
are provided. If you think anything is missing, please contact us using
the helpline numbers on the back of this booklet.
What is inside the box? Parts and Controls
BA AC/DC power adaptor
REVITIVE Ultrasound
C
D
Ultrasound Gel
Carry Case
15
10
5
15
10
5
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67
Before operating your REVITIVE Ultrasound device, please read
these instructions in full and save this manual for future reference.
• May help to relieve pain
• May help to aid healing •Used for the treatment of malignancy (application over a suspected or
confirmed tumour)
•Used on the skin over electronic implants, including pacemakers or
defibrillators
•Used on an infected or bleeding area, including tuberculosis
•Used on the skin over vascular (blood vessel) abnormalities (such as
haemangioma, capillary, lymphatic, arterial or arterio-venous
malformations)
•Used directly on the abdomen or lower back of pregnant women
•Applied directly over active epiphysis regions (growth plates), in the
presence of myositis ossificans (bone formed within the muscle) or
over the eyes, skull or reproductive organs
•Used over open wounds or fragile or damaged skin eg eczema
•Used on the front of the neck over the carotid sinus
•Used over spinal abnormalities e.g. spina bifida, following laminectomy
•Used over active deep vein thrombosis or thrombophlebitis
•Used on recently irradiated tissue (within 6 months)
•Used on heart, eye, testes, near brain, cervical ganglia, spine,
laminectomy sites (can cause spinal cord bleeding).
•Used by individuals who do not comprehend the instructions for
application
REVITIVE Ultrasound should not be:
If you have any doubts about the suitability of REVITIVE Ultrasound,
please consult your healthcare professional before using this product
Introduction to REVITIVE IMPORTANT SAFEGUARDS
READ ALL INSTRUCTIONS BEFORE USE
Suitable for people suffering from muscular injuries, aches, pains and
strains. Especially effective on lower back and shoulders.
INDICATIONS FOR USE CONTRAINDICATIONS
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89
IMPORTANT SAFEGUARDS
•Clean the Treatment Head completely after use as this will prevent any
possible cross-infection to other users
•Keep out of the reach of children
•People with local circulatory insufficiency or bleeding disorder (eg
haemophilia) should consult their health care professional before use
•Do not use on de-sensitised (numb, hypoaesthesia) areas of the skin (eg
diabetic neuropathy)
•Use caution when treating pain of undiagnosed origin with a history of
cancer (within 5 years)
•Use a low intensity setting only over areas containing plastic/
cement implants
•Discontinue use if any signs of inflammation increase (redness, heat,
pain, swelling)
•Discontinue use if ‘pins and needles’ are experienced during treatment
and consult your health care professional
•The socket outlet should be installed near the equipment and should
be easily accessible
•Use only the accessories supplied by, or purchased from, the
manufacturer
HOW TO USE REVITIVE ULTRASOUND
Instructions for use
WARNINGS & CAUTIONS
15
10
5
LOW MEDIUM HIGH
Please read this User’s Manual carefully before using this product.
Plug the adaptor to the Connection Port.
Also plug the adaptor into the mains power supply.
Consult the Therapy Application Table to determine
the appropriate Mode level and Time duration for the
ailment to be treated (see page 12 for details).
Turn the product on by sliding the Power Button
upwards. The Power Indicator will also turn on.
Press the Mode Button to scroll through the
Mode levels. This will cycle through the Mode levels
(Low, Medium and High), as shown by the Mode
Indicators.
SAVE THESE INSTUCTIONS
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10 11
After the Time duration has been completed, the
device will automatically turn off (all Time Indicators
will turn off and the therapy will stop). Once your
therapy session has been completed, turn off the
product by sliding the Power Button downwards. The
Power Indicator will turn off. The product is off when
none of the indicators are lit.
Important: Clean after every use.
(See Cleaning Recommendations page 16).
Instructions for use
Press the Time Button to cycle through the Time
durations (5,10 and 15 minutes), as shown by the Time
Indicators. When in use, the chosen Time Indicator will
be on constantly and the treatment will count down
for the chosen Time duration. If the Time Indicator is
flashing, there is not enough pressure being applied.
(See Troubleshooting, page 17).
Hold the device horizontally with the Treatment Head
facing upwards. Apply the Ultrasound Gel to the
Treatment Head and spread in a circular motion for a
few seconds (see page 15 for details).
Move the Treatment Head in a flat, slow, circular motion
over the skin surface of the treatment area. You should
aim to apply the Treatment Head evenly (in time) over the
surface area.
15
10
5
15
10
5
15
10
5
15
10
5
5Min 10 Min 15 Min0Min
15
10
5
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12 13
Instructions for use
THERAPY APPLICATION TABLE
Use the Therapy Application Tables to create a therapy.
There are three considerations when deciding how to treat the injured area:
1When did the injury occur? If it is in the last seven days, then it is “acute”.
If the injury has existed for a longer period then treat as “chronic”.
2How deep is the problem area? This refers to the estimated thickness
of the tissue where the injury exists in centimetres (or inches).
3How big is the problem area compared with the size of the Treatment
Head of REVITIVE Ultrasound?
Apply the therapy once or twice a day only.
ACUTE (New Injury)
DEPTH OF INJURY CM [INCH] POWER TREATMENT TIME
0.5 [0.2] LOW 3 minutes per treatment head area
1 [0.4] LOW 4 minutes per treatment head area
2 [0.8] LOW 4.5 minutes per treatment head area
3 [1.2] MEDIUM 2 minutes per treatment head area
4 [1.6] MEDIUM 2.5 minutes per treatment head area
Positive effects should be seen in 6 weeks. If symptoms persist, please consult
your healthcare professional. The device is suitable for use for a longer period.
CHRONIC (OLD INJURY)
DEPTH OF INJURY CM [INCH] POWER TREATMENT TIME
0.5 [0.2] MEDIUM 2 minutes per treatment head area
1 [0.4] MEDIUM 2 minutes per treatment head area
2 [0.8] HIGH 1.5 minutes per treatment head area
3 [1.2] HIGH 2 minutes per treatment head area
4 [1.6] HIGH 2.5 minutes per treatment head area
Positive effects should be seen in 6 weeks. If symptoms persist, please consult
your healthcare professional. The device is suitable for use for a longer period.
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14 15
TREATMENT HEAD TEST
Plug the adaptor to the Connection Port.
Also plug the adaptor into the mains
power supply.
Turn the product on by sliding the Power
Button upwards. The Power Indicator will
also turn ON.
Press the Time Button and scroll through
to any Time Duration (see page 10 for
details).
You will not be able to feel the vibration from REVITIVE Ultrasound because it
is operating at an ultrasonic frequency. However, if you are unsure whether the
Treatment Head is vibrating, you can do the following test:
Important: The device will not work unless a
Time Duration is chosen.
15
10
5
TREATMENT HEAD TEST
Instructions for use
TREATMENT HEAD TEST (CONTINUED)
Hold the device horizontally with the Treatment Head
facing upwards. Place a large drop of water on the
Treatment Head and spread in a circular motion for a
few seconds.
Lightly press one finger onto the Treatment Head.
The water will visibly vibrate, demonstrating that the
Treatment Head is working correctly.
Important: The Treatment Head only vibrates if the
conductive fluid (water or gel) covers the entire surface
of the Treatment Head.
Do not immerse in water.
For external use only. Do not use on broken skin. Discontinue use if rash
or irritation occurs.
Always read the label. Use only as directed. If symptoms persist please
consult your doctor.
HOW TO USE YOUR CONDUCTIVE GEL
When using REVITIVE Ultrasound it is essential to use a liberal amount of
Ultrasound Gel in order to reduce friction and assist in the transmission of the
ultrasonic waves deep into the tissue. If the gel is inadequate, the effectiveness
of the therapy may be reduced by up to 90%.
Choose the area of skin to be treated and use water or alcohol to clean it. Then
liberally spread the conductive gel on the skin or directly onto the Treatment Head
of the REVITIVE Ultrasound. During the therapy, the Treatment Head should be
kept in constant motion and flat against the surface of the skin.
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16 17
Do not immerse the device in water.
Do not clean with chemicals.
No part of REVITIVE Ultrasound is suitable for dishwasher use.
Instructions for use Troubleshooting
Important: It is recommended to clean the product after every use.
Clean the Treatment Head with a tissue or a soft, damp cloth. This will remove
any excess Ultrasound Gel.
STORAGE
CLEANING RECOMMENDATIONS
REVITIVE Ultrasound:
When not in use, store the device with the adaptor in a dry room and protect
it against extreme moisture, heat and direct sunlight.
Air pressure, humidity and temperature limits for storage:
REVITIVE Ultrasound Gel:
Wipe nozzle clean and re-cap after each use. Store in a cool, dry place.
-10 °C
50 °C
20 %
93 %
1060 hPa
700 hPa
700 hPa
1060 hPa
No vibration Ultrasound waves, with a vibra-
tion of 1-million times per sec-
ond are too fast to see or feel.
Therefore, you will not feel any
sensation when using REVITIVE
Ultrasound.
To confirm your REVITIVE
Ultrasound is operating,
follow the treatment head
test (See page 14 for
details).
The temperature safety switch
has tripped and the unit has
switched off.
Allow the unit to cool down.
No vibration or
indicators
The product has failed. Contact your dealer.
Unit will not turn on Temperature is too high. Allow to cool.
Time indicator
flashing
Poor contact between the
treatment head and the body,
(not enough pressure is being
applied).
Apply a generous amount
of Ultrasound Gel to create
good contact between
the Treatment Head and
the body. Treatment is
automatically restored when
good contact is restored.
Problem Possible Cause Solution
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18 19
Air pressure, humidity and temperature limits for
storage
Disposal
In accordance with Directive 2012/19/EU(WEEE)
Type of protection against electric shock
Class II Equipment
Only for treatment head:
Protected against the effects of temporary immersion water
Complies with the European Medical Device Directive
(93/42/EEC), amended by directive 2007/47/EC
and 2011/65/EU requirements. Notified body TUV
Rheinland (CE0197)
Consult instructions for use
Mode
Time
0197
Symbols
IPX7
Symbols
Model or type designation/order number
Directive 93/42EEC Annex 1,13,3(a) IEC 60601-1(6.1f)
EN ISO 15223-1:2012
Classification electrical
Device: Type BF
IEC 60601-1(6.1l)
Serial number is on the underside of the device and on
the packaging
Directive 93/42EEC Annex 1,13,3(d)
EN 15223-1:2012
Lot Number including year (YY) and Month (MM) of manufacture
CONTRAINDICATIONS: This describes situations where you
should not use REVITIVE Ultrasound
CAUTION: This highlights warnings and cautions when using the
device. Make sure you understand these before using REVITIVE
Ultrasound
Center Positive Polarity
DANGER
Electric shock risk
Energy Efficiency Grade
Indoor use only
Complies with the European Union Directive
2011/65/EU (Hazardous Substances)
Legal manufacturer of device
EU/EC European Authorised Representative
XXXXXXXX
SN
IV
RoHS
REF UT1033
YYMMXXXX
LOT
-10 °C
50 °C
20 %
93 %
1060 hPa
700 hPa
700 hPa
1060 hPa
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20 21
REVITIVE Ultrasound is intended for use in an electromagnetic environment in which
radiated RF disturbances are controlled. The user of REVITIVE Ultrasound can help prevent
electromagnetic interference by maintaining a minimum distance between portable and
mobile RF communications equipment (transmitters) and REVITIVE Ultrasound
as recommended below, according to the maximum output power of the
communications equipment.
Rated
maximum
output power
of transmitter
(W)
Separation distance according to frequency of transmitter (m)
150 KHz to 80
MHz
d= 3.5
V1
�P
80 MHz to 800
MHz
d= 3.5
E1
�P
800 MHz to 2.5 GHz
d= 7
E1
�P
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
11.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended
separation distance D in metres (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 reflection from structures, objects and people.
RECOMMENDED SEPARATION DISTANCES
BETWEEN PORTABLE AND MOBILE RF
COMMUNICATIONS EQUIPMENT AND EQUIPMENT
OR SYSTEMS THAT ARE NOT LIFE SUPPORTING.
Technical SpecificationsTechnical Specifications
REVITIVE Ultrasound is intended for use in the electromagnetic
environment specified below. The user of REVITIVE Ultrasound should assure that it is
used in such an environment.
Emission test Compliance Electromagnetic environment –
guidance.
RF emissions CISPR 11 Group 1
REVITIVE Ultrasound 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 REVITIVE Ultrasound 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 61000-3-3 Class A
Voltage fluctuations/flicker
emissions IEC 61000-3-3 Complies
•Power Supply:
Input: AC 100-240V, 50/60 Hz, 0.35A Output: DC 15V, 1.2A
• Frequency: 1MHz (±10%)
•Mode: 3 levels (Low, Medium, High)
•Time: 5, 10 or 15 minutes with auto turn off
•Power Output: (0.7W/cm2(Low), 1.0W/cm2(Medium), 1.2W/cm2(High)
•Duty Factor: 30% (Low), 40% (Medium), 50% (High)
•RBN : < 8.0
•Rated Output Power: 9.6W (±20%)
•Effective Intensity: 2.4W/cm2(±20%)
•AER : 4 cm2
•Beam Type: Collimated
•Modulation Wave Shape: Pulsed
•Operating Conditions:
Temperature: 5-40°C Humidity: 30-75%RH Air Pressure: 700-1060hPa
GUIDANCE AND MANUFACTURER’S DECLARATION -
ELECTROMAGNETIC EMISSIONS FOR
ALL EQUIPMENT AND SYSTEMS
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22 23
Your international 2 year warranty
It is important to retain the retailer’s receipt
as proof of purchase; we suggest you
staple your receipt to this manual for future
reference.
In the unlikely event of your product proving
to be faulty within 28 days of purchase it
should be returned to the place where
you bought it. If a fault develops after this
period we grant a 2 year limited guarantee
on the product commencing on the date of
purchase.
Within the guarantee period we will
eliminate, free of charge, any defects in the
product resulting from faults in materials
or workmanship, either by repairing or
replacing the complete product as we may
choose.
To obtain service within the guarantee
period contact your local distributor. You
will be asked to return the product (in
secure, adequate packaging) together with
a copy of proof of purchase. Subject to the
exclusions set out below (see Exclusions
below) the faulty product will then be
repaired or replaced within 7 working days
of receipt. The guarantee extends to every
country where this product is supplied by
Actegy or its appointed distributor.
If, for any reason, the product is replaced
during the 2 year guarantee period,
the guarantee on the new item will be
calculated from the original purchase date.
Exclusions
Actegy Ltd shall not be liable to replace
or repair the goods under the terms of the
guarantee where:
•Damage or the fault is due to improper
use, normal wear or use, accidental use,
misuse, negligent use or use contrary to the
manufacturer’s recommendations or where
the fault has been caused by power surges
or damage carried out during transit.
•Defects have a negligible effect on the
value or operation of the appliance.
•The device has been used on a voltage
supply other than that stated on the product
or used with a power adapter other than the
one supplied with the product.
•Repairs have been attempted or
undertaken by a person other than our
service staff (or an authorised dealer) or if
original REVITIVE parts are not used.
•The device has been used for hire
purposes or non-domestic use.
•The device is second hand.
Actegy Ltd are not liable to carry out any
type of servicing work under the guarantee.
This guarantee does not confer any
rights other than those expressly set out
above and does not cover any claims
for consequential loss or damage. This
guarantee is offered as an additional benefit
and does not affect your statutory rights as
a consumer.
To activate your warranty please register your device at www.revitive.com
If you prefer you can also post your registration, see warranty/guarantee card
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24
CONTACT INFORMATION
Country Contacts:
Actegy Ltd.
REFLEX, Cain Road, Bracknell, RG12 1HL, UK
Tel: [phone]
REVITIVE Ultrasound
complies with the WEEE Directive.
Save our green planet.
Regulatory Certification
UK/Europe Class IIa medical device
AU/NZ Class IIb medical device
ISO 13485 – Manufactured under the international
quality management standard for medical devices.
Made in PRC.
Shanghai International Holding Corp. GmbH (Europe)
Eiffestraße 80, 20537, Hamburg, Germany
Shenzhen Dongdixin Technology Co Ltd
No3 Building, Xilibaimang Xusheng
Industrial Estate, 518108, Nanshan
Shenzhen, PRC.
Copyright © 2017 Actegy Ltd. All rights reserved.
ACTEGY® and REVITIVE® are registered trademarks
of Actegy Ltd. The REVITIVE product is a proprietary
design and is protected by applicable design laws.
AW 3269_IFU02_14269060 PD 07.2017
RoHS
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