Roscoe Medical SoundCare Plus Operating Instructions Manual

SoundCare™ Plus Pain Relief Device

Operating instructions

Medical device for pain treatment

based on ultrasound

www.roscoemedical.com

INSTRUCTION MANUAL

2

Contents

1. FOREWORD…………………………………………………..…...3

2. SAFETY PRECAUTIONS…………………………………………...3

3. INDICATIONS AND CONTRAINDICATIONS…………………...6

4. PRESENTATION…………………………………………………....7

5. INSTALLATION…………………………………………………… 10

6. OPERATION……………………………………………………...13

7. MAINTENANCE……………..…………………………………...15

8. DIAGNOSTICS………………………………….………………..16

9. SPECIFICATIONS AND TECHNICAL DATA…………..……….. 17

10.STORAGE ………………………………………………………...18

11.DISPOSAL……………………...…………………….......……..18

12.STANDARDS AND REQUIREMENTS………….………………...19

13.GUIDANCE AND MANUFACTURER'S DECLARATION…..….. 19

14.WARRANTY…………………………………………………….…23

15.NORMALIZED SYMBOLS……………………………..…………24

SoundCare™ Plus Pain Relief Device

1.
FOREWORD

1.1
General

This manual has been written for the users of the
SoundCare™ Plus. It contains general information on the operation,
precautionary practices, and maintenance information. In order to
maximize use, efficiency, and the life of the system, please read this
manual thoroughly and become familiar with the controls, as well as the
accessories before operating the system.

ultrasound therapy

This user manual is published by Roscoe Medical, Inc.
Roscoe Medical, Inc. does not guarantee its contents and reserves the right
to improve and amend it at any time without prior notice. Amendments will
however be published in a new edition of this manual.

1.2
Therapy
possibilities

The lus is an apparatus featuring an
ultrasound therapy unit. Pain affects the quality and enjoyment of life,
especially for those who suffer chronic pain.SoundCare™ Plus is ultrasound
therapy device for the treatment of chronic and acute muscular pain.

ultrasound therapy SoundCare™ P

1.3
Treatment
head

The ultrasound treatment heads for the SoundCare™ Plus are so-called multi­frequency heads. This treatment head can now supply both 1 and 3MHz
ultrasound. The head has excellent beam characteristics, fully meeting
the requirements of the existing standards. The excellent beam characteristics,
ergonomic design and effective contact control of the multi-frequency
treatment heads make an optimal treatment possible.Standard accessories

2

include a ultrasound head with 5cm that can work at 1MHz and 3MHz.
User can also choose to purchase ultrasound head with 1cm ER that can
also work at 1MHz and 3MHz.

AAER

1.4
Finally

You have made a wise choice in selecting the SoundCare™ Plus. We are
confident that your unit will continue to give satisfaction over many years
of use. Nevertheless, if you have any inquiries or suggestions, please
contact your authorized distributor.

2.
SAFETY
PRECAUTIONS

2.1
PRECAUTION­ARY
DEFINITIONS

The precautionary instructions found in this section and throughout this
manual are indicated by specific symbols. Understand these symbols and
their definitions before operating this equipment. The definition of these
symbols are as follows.

3

2

Caution: Text with a “CAUTION” indicator will explain possible

safety infractions that could have the potential to cause minor to
moderate injury or damage to equipment.

SoundCare™ Plus Pain Relief Device

Warning: Text with a “WARNING” indicator will explain possible

safety infractions that will potentially cause serious injury and
equipment damage.

Danger: Text with a “DANGER” in dicator w ill expla in possible

safety infractions that are imminently hazardous situations that
would result in death or ser ious injury.

2.2
CAUTION

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.
Keep yourself informed of the contraindications.
Never leave the patient unattended during treatment.
Do not operate the device when connected to any other medical
devices.
Do not operate this unit in an environment where other devices are
used that intentionally radiates electromagnetic energy in an
unshielded manner.
Ultrasound should be routinely checked before each use to determine
that all controls function normally, especially that the intensity control
does properly adjust the intensity of the ultrasonic power output in a
stable manner. Also, determine that the treatment time control does
actually terminate ultrasonic power output when the timer reaches zero.
Do not use sharp objects such as pencil point or ballpoint pen to
operate the buttons on the control panel.
Before each use, inspect Ultrasound Applicator for cracks, which may
allow the ingress of conductive fluid.
Inspect Applicator cables and associated connectors before each use.
The ultrasound therapy control unit is not designed to prevent the
ingress of water or liquids. Ingress of water of liquids could cause
malfunction of internal components of system and therefore create
risk of injury to the patient.
Caution should be used for patients with suspected or diagnosed
epilepsy.
Refer to recent surgical procedures when muscle contraction may
disrupt the healing process.
Do not use over the menstruating or pregnant uterus, and over areas
of the skin which lack normal sensation.

4

SoundCare™ Plus should not be used when driving, operating
machinery, or during any activity in which involuntary muscle
contractions may put the user at undo risk of injury.

SoundCare™ Plus Pain Relief Device

2.3
WARNING

Warning

2.4
Danger

Danger

Patients with an implanted neurostimulation device must not be treated
with or be in close proximity to any shortwave diathermy, microwave
diathermy, therapeutic ultrasound diathermy, or laser diathermy anywhere
on their body. Energy from diathermy (shortwave, microwave, ultrasound,
and laser) can be transferred through the implanted neurostimulation
system, can cause tissue damage, and can result in severe injury or death.

5

SoundCare™ Plus Pain Relief Device

To avoid the risk of electric shock, the SoundCare™ Plus must only
be connected to a supply mains with protective earth.
Care must be taken when operating this equipment around other
equipment. Potential electromagnetic or other interference could
occur to this device or to the other equipment. Try to minimize this
interference by not using other equipment in conjunction with
SoundCare™ Plus.
The device may not be used in close proximity (i.e. less than 2 meters)
to short-wave equipment.
The device may not be used in so - called “wet rooms” (hydrotherapy
rooms)
The user must keep the device out of the reach of children.
Only use the device for the recommended applications. The device
should be used under medical supervison.
Use of controls or adjustments to or performance of procedures other
than those specified in the instruction manual may result in hazardous
exposure to ultrasonic energy.
Before administering any treatment to a patient you should become
acquainted with the operating procedures for each mode of treatment
available, as well as the indications, contraindications, warnings,
and precautions. Consult other resources for additional information
regarding the application of the Ultrasound.
Do not use solvents to clean the device.
A damaged device must no longer be used.
The device must only be serviced, repaired and opened by authorized
sales center.
Dispose of the device in accordance with local regulations. Keep the
operating instructions with the device.
Pregnant and nursing women should use the device cautiously.
Use the device cautiously when using it on immature bones.
For continuous and effective treatment, the device should not be used
more then 30 minutes per day.
Do not use cellphone while the device is in operation.
Use sensitive coupling glue cautiously.
Always keep the sound head in constant motion.

Injury, damage, or death can occur during diathermy therapy even if the
implanted neurostimulation system is turned “off.”

3.
Indications and
Contraindications

3.1
Indications

1) Application of therapeutic deep heat can be used for the treatment
of selected sub-chronic and chronic medical conditions such as:

• Relief of pain, muscle spasms and joint contractures that
may be associated with:

• Adhesive capsulitis

• Bursitis with slight calcification

• Myositis

• Soft tissue injuries

• Shortened tendons due to past injuries and scar tissues

2) Relief of sub-chronic and chronic pain and joint
contractures resulting from:

• Capsular tightness

• Capsular scarring

3) This device should be used in the hospital and home.

4) This device should be operated only by the experienced physician.

3.2
Contraindi­cations

• This device should not be used for symptomatic local pain
relief unless etiology is established or unless a pain
syndrome has been diagnosed.

• This device should not be used when cancerous lesions are
present in the treatment area.

• This device should not be used when open wounds are
present in the treatment area.

• This device should not be used on patients suspected of
carrying serious infectious disease and or disease where it
is advisable, for general medical purposes, to suppress
heat or fevers.

• This device should not be used over or near bone growth
centers until bone growth is complete.

• This device should not be used over the thoracic area if the
patient is using a cardiac pacemaker.

• This device should not be used over a healing fracture.

• This device should not be used over or applied to the eye.

• This device should not be used over a pregnant uterus.

• This device should not be used on 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.

• This device should not be used over tumors.

6

SoundCare™ Plus Pain Relief Device

4.
PRESENTATION

4.1
Presentation
of the
device

1) Program adjustment button

2) 1MHz and 3MHz adjustment button

3) Duty cycle adjustment button

4) Timer adjustment button

5) Liquid crystal display

6) Stop button

7) Output intensity adjustment knob and pause button

8) Treatment head select button

9) The socket of treatment head (5cm )

10) The socket of treatment head (1cm )

11) Adapter Receptacle

12) Power switch

7

PROG RAM

FREQ UENCY

DUTY C YCLE

TIME R

PO WER

SET

MHz

w

cm

2

1cm

2

5cm

2

5

7

6

1
2
3
4

8

9

10

11
12

2

2

SoundCare™ Plus Pain Relief Device

8

4.3
Treatment
head

1) Sound head
The component of the Applicator which makes contact with the
patient during the Ultrasound therapy treatment of the time.

2) Applicator LED

The component of the Applicator which indicates if the Sound head
is working or Nonworking on the treatment area.

3) Applicator

The assembly that connects to the System and incorporates the
Sound Head.

4.2
Liquid
crystal
display

PR OGRAM

FR EQUEN CY

DU TY CYCLE

TI MER

POWER

SET

MHz

w

cm

2

7

6

5

1

2

3

4

1cm

2

5cm

2

8

1) Program indicator

2) Frequency indicator

3) Duty cycle indicator

4) Timer indicator

5) Output intensity/power

6) Ultrasound output indicator

7) Pause indicator

8) Treatment head type

1

2

3

SoundCare™ Plus Pain Relief Device

9

w

cm

2

w

PAUSE

ULTRASOUND OUTPUT POWER

ULTRASOUND INTENSITYOUTPUT

TREATMENT TIME

4.5
Key
Function

ON/OFF Switch
Ø With this button the SoundCare™ Plus is turned on or off.

Pause Knob
Ø Pause/Restore treatment working

Intensity Knob
Ø Rotating the intensity control Knob to start treatment
Ø Set intensity by rotating the intensity control Knob to the prescribed
level

Ø Clockwise-Increase Intensity
Counterclockwise-Decreases Intensity

Escape button
Ø Stop treatment

4.4
Symbol
definitions

Below are the definitions for all of the symbols used in the Ultrasound
therapy device . Study and learn these symbols before any operation
of the system.

STOP TREATMENT

START / PAUSE BUTTON

ULTRASOUND INTENSITY

ULTRASOUND APPLICATOR STATE

POLARITY OF POWER SUPPLY

THE CONNECTION SOCKET OF TREAMENT HEAD

ON/OFF SWITCH

SoundCare™ Plus Pain Relief Device

10

5.2
Connection

Mains supply connections must comply with the national requirements
regarding medical rooms. The equipment has a safety earth (ground)
connection, and must be connected to an earthed ( grounded ) wall
socket.
Prior to connection of this devices to the mains supply, check that the
voltage and frequency stated on the type plate correspond with the
available mains supply.
The main adapter is a part of the supply circuit on which the device's
safety partly depends on. We recommend that you use the MPU50-160
type with of medical power. If you can not find the same type of medical
power, please choose the same specifications (Output:DC15V/3A)
medical power.

Plug the applicator’s connection plug into the corresponding socket
connection on SoundCare™ Plus in accordance with the direction that
marked at the applicator connector.
If connected correctly, LCD will show the picture in Figure 1, if connection
error, LCD will show the picture in Figure 2.

Caution: For your health, if you change the AC/DC adaptor, it must
conform to the requirement of the standard medical electrical
equipment.

5.3
Connect the
treatment
head

Connect the supplied mains adapter to the connector.
Connect the mains adapter to a wall socket.

UP and DOWN Arrows
Ø Controls used in various modality parameter screens to navigate or

change a value up or down within the parameter.

5.0
INSTALLATION

5.1
Reception
of
equipment
and
accessories

Remove the Therapy System and all accessories from shipping cartons.
Visually inspect for damage. Report any damage to the carrier.

Your ultrasound therapy is supplied with case containing:

1
1
1
1
1
1

SoundCare™ Plus Pain Relief Device

Ultrasound therapy unit

2

Ultrasound head with 5cm AER

2

Ultrasound head with 1cm AER
Adapter 1.35A to 100~240V
Lead for adapter
User manual

11

Program Down key: Press this button to programchoose

PR OGRA MPR OGRA M PR OGRA M

PR OGRA M

PR OGRA M

5.5.2
Choice/
Select the
Ultrasound
Frequency:
1MHz or
3MHz

Freq Up key: Press this button to the Ultrasound Frequencychoose

FR EQUE NCY

MH z

FR EQUE NCY

MH z

FR EQUE NCY

MH z

FR EQUE NCY

MH z

Freq Down key: Press this button to the Ultrasound Frequency choose

Caution:SoundCare™ Plus can only use the applicator that

attached with main unit by the manufacturer. Please do not use
other type of applicator.

5.4
Switching
on and
self-test

Switch on the device, using the power switch.
Immediately after switching on, the device carries out a self-test.
At the end of the self-test a beep is heard. When an error is found an error
code will appear on the display. See section 8 for details.

5.5
Therapy
system
set up

SoundCare™ Plus has 10 kinds of treatment procedure models. Users
can program their own operating parameters for treatment :

1. Ultrasonic frequency;

2. The treatment duty cycle;

3. Treatment time.
Operating parameters will be stored automatically ; and will not be
lost when power is lost or upon shutdown.

5.5.1
Choice/
Select
therapy
Program:
U01-U10

Program Up key: Press this button to choose the program

PR OGRA M PR OGRA M PR OGRA M

PR OGRA M

PR OGRA M

PROG RAM

FREQ UENCY

DUTY C YCLE

TIME R

PO WER

MHz

w

cm

2

Figure 1

Figure 2

DUTY C YCLE

TIME R

MHz

PROG RAM

FREQ UENCY

1c m
5c m

2

2

SoundCare™ Plus Pain Relief Device

12

Time Down key: Press this button to decrease the treatment time

TI MERTI MER

TI MER

TI MER

TI MER

TI MER

TI MER

DU TY CYC LE

DU TY CYC LE

5.5.5
Setting
the
treatment
time:1
min-30min,
stepping
1 min

Time Up key: Press this button to increase the treatment time

TI MER

TI MER

TI MER

5.5.3
Choice/
Select the
treatment

2

head 1cm

2

or 5cm

2 2

Select the treatment head 1cm or 5cm by pressing the treatment
head select button.

5.5.4
Choice/
Select the
duty cycle:
10%-100%,
stepping
10%

Duty Up key: Press this button to increase the duty cycle

DU TY CYC LE

DU TY CYC LE

DU TY CYC LE

DU TY CYC LE

DU TY CYC LE

Duty Down key: Press this button to decrease the duty cycle

DU TY CYC LE

DU TY CYC LE

DU TY CYC LE

1cm

2

5cm

2

1cm

2

5cm

2

1cm

2

5cm

2

2 2

CAUTION: The user can select the treatment head 1cm or 5cm by
pressing the treatment head select button when the two types of treatment
head have been connected with the device. The device can default to
select the treatment head automatically when only one treatment head is
connected to the device.

SoundCare™ Plus Pain Relief Device

13

Caution

The massage performed with the head should be applied with regular
movement, not too slow to avoid inducing heat, nor too fast to prevent a
bad contact which would reduce the effectiveness of the treatment.

6.1.2
During
the
treatment

The treatment-head has to be moved constantly in a slow tempo, also
in case of the semi-statically method.
Ask the patient regularly about his/her experiences. If necessary, the
treatment can be adjusted. By using knob [7], the intensity can be
reduced.
In case of indications of poor transmission of ultrasound energy, it is
advised to add the contact-gel or reposition the ultrasound-head.
During the treatment, if the ultrasonic applicator is connected well,
the applicator LED will light; if the ultrasonic applicator doesn't
contact well, the applicator LED will blink slowly, the system will be
think this is no-load in the applicator. When treatment is paused, the
applicator LED light will be extinguished. And the countdown will
also be suspended.

5.6
Disconn­ecting
from the
mains

Switch off the SoundCare™ Plus, by pressing the main switch.
Pull out the main plug of the mains adapter from the adapter Receptacle.

6.
OPERATION

6.1
Measures
with regard
to treatments

6.1.1
Before
the
treatment

Put the patient in a comfortable position. The area to be treated should
be properly supported and exposed and perfectly relaxed.
Inform the patient on the purpose of the treatment and the sensation he
will perceive in the course of the therapy.
Ensure there are no contraindications to treatment.
Inspect the patient's skin accurately for any abrasions, inflammation,
surface veins, etc.
Clean the area to be treated with 70% alcohol or soap.
It is advisable to shave areas of excessive hair-growth.

SoundCare™ Plus Pain Relief Device

14

6.2.3
Ultrasound
intensity

The ultrasound intensity is adjusted with intensity control knob. The
ultrasound intensity can only be adjusted during treatment. The

2

ultrasound intensity can be displayed in W or W/cm . (Press the buttons

2

[1], [2], [3], [4],[8] can change the displayed W or W/cm )

6.2.4
Pause

Press the knob [7] to pause the treatment. Press the knob [7] ag ain to
restore the trea tment.

6.2.5
Emergency
stop

Pressing button [6] simultaneously will terminate all active treatments.

6.3
The
treatment
head

A treatment head is a precision instrument. Great care is taken in the
development and production in order to obtain the best possible beam
characteristics. Rough treatment (jarring or dropping) can adversely affect
these characteristics, and must therefore be avoided.

Warning

If you want to replace the treatment head, you need to turn the power
switch off, so that the device is in shutdown state in order to replace the
treatment head.

6.1.3
After the
treatment

Clean the treatment area well before treatment as well as the treatment

-head by using a towel or a tissue.
The treatment-head should be cleaned with a 70% alcohol solution.
Check if there are any signs of improvement (e.g. pain, circulation and
mobility).
When entering the next treatment-session, the patient is instructed to
report any possible reaction.

6.2
Operating
the
device

6.2.1
Switch on the
device

Turn the device on using the On/Off . switch. The device executes a self­test; checking all important functions and presents itself with the start up
settings. The start up settings is adjustable at memory location. To
personalize the start up settings, refer to chapter 5.5, Therapy system
set up.

6.2.2
Adjusting
parameters

Press the buttons [1], [2], [3], [4] to select a parameter.

SoundCare™ Plus Pain Relief Device

15

7.
MAINTENANCE

7.1
Cleaning
of the
device

Switch off the device and disconnect it from the mains supply.
The device can be cleaned with a damp cloth. Use lukewarm water
and a non-abrasive liquid household cleaner (no abrasive, no alcohol
content solution). If a more sterile cleaning is needed, use a cloth

moistened with an antimicrobial cleaner.

Caution: Do not submerse the device in liquids. Should the device

accidentally become submersed, contact the dealer or Authorized
Service center immediately. Do not attempt to use the system that has
been emersed in liquid until inspected and tested by a Service
Technician Certified by an Authorized Service center. Do not allow
liquids to enter the ventilation holes in the optional modules. This
could permanently damage the modules.

6.4
The contact
medium

In order to ensure efficient transfer of energy, a contact medium is
required between the treatment head and the body. Air causes virtually
total reflection of the ultrasound energy. The best medium for the transfer
of ultrasound energy is a gel.

Liberally apply transmission gel to the treatment area on the patient.
Move the treatment head during therapy session in a circular motion.
The area treated should be two times the diameter of the treatment
head.
If the body surface is very irregular, making it difficult to obtain good
contact between the treatment head and the body, or if direct contact
must be avoided (e.g. due to pain), the affected area may be treated
under water (subaqual method). The water should be degassed (by
previous boiling ) in order to prevent air bubbles arising on the
treatment head and body.

Caution: Never apply the gel to the treatment head. The treatment
head will register this as contact and may emit ultrasound energy,
which could damage the treatment head.

Always use gel with the requirements for medical use, such as with
CE mark, or are legally marketed in the US.

SoundCare™ Plus Pain Relief Device

16

Figure 3

Cleaning
of the
treatment
heads

7.2

The treatment heads and cables should be regularly inspected for damage,
e.g. hairline cracks, which could allow penetration by liquids. Clean the
contact surface immediately after each treatment. Make sure that no
ultrasound gel remains on the treatment head. We further recommend
cleaning the head and cable daily, using lukewarm water. The treatment
heads can be disinfected using a cloth moistened with 70% alcohol.

7.3
Maintenance

Maintenance and all repairs should only be conducted by the dealer
agency. The manufacturer will not be held responsible for the results of
maintenance or repairs completed by unauthorized persons.
The service and or maintenance must be carried out by conform to the
procedure described in the manual of the apparatus.
Opening of the device by unauthorized agencies is not allowed and
will terminate any claim to warranty.

8.
Diagnostics

8.1
Displays
fail to light
up

Check to see if the main adapter is connected to the device and the main
supply.

The device has discovered a fault during or after the self-test.
The error displays the following figure 3. Remove any applicators or cables
from the output sockets and switch the device off and on again. If the
code re-appears, contact your supplier. The device is probably defective.

8.2 Error

SoundCare™ Plus Pain Relief Device

17

Technical data of power supply

8.3
The contact
control fails
to operate

DU TY CY CLE

TI MER

MH z

PR OGR AM

FR EQU ENCY

Check the connected plug of ultrasound applicator.

Figure 4

9.
SPECIFICATIONS
AND TECHNICAL
DATA

9.1
Electrical
data

Technical data of device

Acoustic Frequency:

Output Power:

P :ulse repetition rate
Duty factor :

Timer:
Effective radiating area (A )ER

Effective intensity (M ax.)

RB N (Max):
Beam type:
Material of applicator:

Waterpro of Grade

1MHz±10%,3MHz±10%

100Hz±10%
10%-100%,Stepping 10%
Max 30 minutes

2

5.0cm 20%;±

2

3.0W/cm ±20%(1MHz),

2

3.0W/cm ±20%(3MHz)

5.0
Collimated
Aluminium

IPX7 Only for treatment head

2

1.0cm 20%±

Adapter supply voltage:
Adapter output:
Dimensions:

100V-240V, 47Hz-63Hz, 1.35A
15V 3A Max.
143mm(L)x73mm(W)x40mm(H)

Classification of protection
against electric shock

Class I medical equipment

Classification of applied part

Type BF

SoundCare™ Plus Pain Relief Device

18

11.
DISPOSAL

Please dispose of the device in accordance with the directive 2002/
96/EC WEEE (Waste Electrical and Electronic Equipment). If you
have any questions, please refer to the local authorities responsible
for waste disposal.

Environmental conditions for storage

Environment temperature: -10 -55
Relative humidity: 10%-90%
Atmospheric pressure: 700-1060hPa

℃ ℃

9.2
Program
List Table

Program

U-01
U-02

U-03
U-04

U-05
U-06

U-07

U-08
U-09
U-10

Frequency

1MHz
1MHz

1MHz
1MHz

3MHz
1MHz

1MHz

1MHz
1MHz
3MHz

Duty
Cycle

80%
50%

50%
50%

80%
30%

80%

80%
50%
80%

Treatment

Time
10 minutes
10 minutes

20 minutes
15 minutes

15 minutes
15 minutes

15 minutes

8 minutes
12 minute
10 minutes

Suggest
Intensity

2

1.0W/cm

2

1.0W/cm

2

1.5W/cm

2

1.0W/cm

2

1.5W/cm

2

2.0W/cm

2

1.0W/cm

2

1.5W/cm

2

1.0W/cm

2

1.5W/cm

2

1.5W/cm

2

1.5W/cm

2

1.0W/cm

For a prolonged pause in treatment, store the device with the adapter in a
dry room and protect it against heat, sunshine and moisture.
Store the machine in a cool, well-ventilated place.
Never place any heavy objects on the machine.

10.
STORAGE

SoundCare™ Plus Pain Relief Device

Environmental conditions for use

Environment temperature: 10-40
Relative humidity: 30%-85%
Atmospheric pressure: 800-1060hPa

℃

19

13.
GUIDANCE
AND
MANUFACTURER'S
DECLARATION

13.1
Declaration­electro­magnetic
emissions

Guidance and manufacturer's declaration - electromagnetic
emissions

The SoundCare™ Plus device is intended for use in the electromagnetic

environment specified below. The customer or the user of the SoundCare™Plus

should assures that it is used in such an environment.

Emissions test

Compliance Electromagnetic

environment - guidance

RF emissions
CISPR 11

Group 1

The SoundCare™ Plus device 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
CISPR11

Class B

Harmonic
emissions
lEC 61000-3-2

Not
applicable

Voltage
fluctuations /
flicker emissions

lEC 61000-3-3

Not
applicable

The SoundCare™ Plus device is
suitable for use in all
establishments including
domestic and those directly
connected to the public
low-voltage power supply
network that supplies buildings
used for domestic purposes.

SoundCare™ Plus Pain Relief Device

12.
STANDARDS
AND
REQUIREMENTS

Roscoe Medical, Inc. declares that the device complies with
following normative documents:
IEC/EN60601-1, IEC/EN60601-1-2, IEC/EN60601-2-5,
IEC/EN61689, IEC60601-1-4,IEC62304,ISO10993-5,
ISO10993-10, ISO10993-1,ISO14971.

20

13.2
Declaration ­electromagnetic
immunity

Guidance and manufacturer's declaration-electromagnetic
immunity

The SoundCare™ Plus device is intended for use in the electromagnetic
environment specified below. The customer or the user of the
SoundCare™ Plus should assure that it is used in such an environment.

Immunity
test

IEC 60601

test level

Compliance
level

Electromagnetic
environment - guidance

Electrostatic
discharge
(ESD)
lEC 61000­4-2

±6 kV
contact
±8 kV air

±
contact
±8 kV air

6 kV

Floors should be wood,
concrete or ceramic tile.
If floors are covered with
synthetic material, the
relative humidity should
be at least 30 %.

13.3
Declaration­electromagnetic
immunity

Guidance and- manufacturer's declaration. Electromagnetic
immunity

The SoundCare™ Plus device is intended for use in the electromagnetic
environment specified below. The customer or the user of the
SoundCare™ Plus should assure that it is used in such an environment.

Immunity
test

IEC 60601

test level

Compliance
level

Electromagnetic
environment - guidance

Conducted
RF lEC
61000-4-6
Radiated RF
lEC 61000­4-3

3 Vrms
150 kHz to
80 MHz
3 V/m
80 MHz to

2.5 GHz

3 Vrms

3 Vrm

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

d=1.2

P

d=1.2

P

d=2.3

P

80MHz to 800MHz

80MHz to 2.5MHz

SoundCare™ Plus Pain Relief Device

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 fixed
RF transmitters, as
determined by an
electromagnetic site

a

survey, should be less
than the compliance level

b

in each frequency range.
Interference may occur in
the vicinity of equipment
marked with the following.

NOTE I At 80 MHz ends 800 MHz the higher frequency range
applies.
NOTE 2 These guidelines may not apply in all situations.
Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.

a. Field strengths from fixed transmitters, such as base stations for
radio ( cellular / cordless) telephones and land mobile radios,
amateur radio, AM and FM radio broadcast and TV broadcast
cannot be predicted theoretically with accuracy. To assess the
electromagnetic environment due to fixed RF transmitters, an
electromagnetic site survey should be considered. If the measured
field strength in the location in which the SoundCare™ Plus device
is used exceeds the applicable RF compliance level above,
should be observed to verify normal operation. If abnormal
performance is observed, additional measures may be
necessary, such as reorienting or relocating the SoundCare™ Plus.
b. Over the frequency range 150 kHz to 80 MHz, field strengths
should be less than [V ] V/m.

i

21

SoundCare™ Plus Pain Relief Device

13.4

Recommended
separation
distances
between
portable
and mobile

RF communications equipment and the SoundCare™ Plus device

Recommended separation distances between portable and mobile
RF communications equipment and the SoundCare™ Plus device

The SoundCare™ Plus device is intended for use in an electromagnetic environment
in which radiated RF disturbances are controlled. The customer or the user of the
SoundCare™ Plus device can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF communications
equipment (transmitters) and the SoundCare™ Plus 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

80 MHz to

800 MHz

800 MHz to
2,5 GHz

d=1.2

P

d=1.2

P

d=2.3

P

0,01 0.12 0.12 0.23
0,1 0.38 0.38 0.73
1 1.2 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 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) accordable to the transmitter manufacturer.

NOTE I 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.

22

SoundCare™ Plus Pain Relief Device

14.
WARRANTY

23

SoundCare™ Plus Pain Relief Device

Please contact your dealer or the device centre in case of a claim under
the warranty. If you have to send in the device, enclose a copy of your
receipt and state what the defect is.
A. The following warranty terms apply:

• The warranty period for SoundCare™ Plus products is one year from
date of purchase. In case of a warranty claim, the date of purchase
has to be proven by means of the sales receipt or invoice.

• Defects in material or workmanship will be removed free of change
with in the warranty period.

• Repairs under warranty do not extend the warranty period either for
the device or for the replacement parts.
B. The following is excluded under the warranty:

• All damage which has arisen due to improper treatment, e.g.
nonobservance of the user instruction.

• All damage which is due to repairs or tampering by the customer
or unauthorized third parties.

• Damage which has arisen during transport from the manufacturer
to the consumer or during transport to the service centre.

• Accessories which are subject to normal wear and tear.

• Liability for direct or indirect consequential losses caused by the
unit is excluded even if the damage to the unit is accepted as a
warranty claim.

Type BF Applied Part

Risk of electric shock

Complies with the safety requirements of Canada and U.S.
The certification body is UL, the cerificate number is E230351

Indoor use only

The electrical safety meet the CB system requirements

The name and the address of the manufacturer

15.
NORMALIZED
SYMBOLS

Batch code

LOT

SN

0197

24

Disposal in accordance with Directive
2002/96/EC (WEEE)

IPX7

Only for treatment head: Protected against the effects of
temporary immersion water

E2 3035 1

Serial Number of product

Complies with the European Medical Device Directive
(93/42/EEC) and amended by directive 2007/47/EC
requirements. Notified body TÜV Rheinland (CE0197)

Please attention to adjust the effective intensity

Refer to Instruction Manual.

SoundCare™ Plus Pain Relief Device

Manufacturer for Roscoe Medical, Inc.

21973 Commerce Parkway, Strongsville, Ohio 44149

www.roscoemedical.com

0197