Enraf-Nonius CD-ROM COMPACT-II Manuale utente

COMPACT-II

Electromagnetic Stimulator

EN109-3442204-40 IFU

August 15, 2022

Instructions for use

Page 2 of 42 EN109-3442204-40 IFU

Preface

The user of this device must sufficiently understand its functions and the precautions that must be

observed for its safe use and stable performance.

For the safe use and post management of the device, be sure to thoroughly understand the details

of the Instructions for use before using the device. This is essential to guaranteeing the safe use and

stable performance of the device.

The Instructions for use provides a guide to the efficient use of the COMPACT-II. For clinical

definitions, pathological effects etc., of its functions, refer to the related medical publications.

As the Instructions for use has been arranged in independent chapters, some of the descriptions

have been duplicated.

If you encounter any problems during operation of the equipment, stop its use immediately, and

contact the customer service center of Enraf-Nonius (Refer to chapter 12).

 
Page 3 of 42  EN109-3442204-40 IFU 
Contents 
Information on safety .................................................................................................................................. 5 
1 Definitions of symbols............................................................................................................................................. 5 
2 Requirements for safety ......................................................................................................................................... 8 
3 Safety device ............................................................................................................................................................... 11 
4 Contraindication ....................................................................................................................................................... 11 
High induction magnetic field .............................................................................................................. 12 
1 Principle ........................................................................................................................................................................ 12 
2 Intended use ............................................................................................................................................................... 12 
3 Device description ................................................................................................................................................... 12 
Installation ....................................................................................................................................................... 13 
1 Components ................................................................................................................................................................ 13 
2 Electrical installation condition ........................................................................................................................ 13 
3 Environmental condition ...................................................................................................................................... 14 
4 Installation method ................................................................................................................................................. 14 
Product description .................................................................................................................................... 16 
1 External view .............................................................................................................................................................. 16 
2 Controls ......................................................................................................................................................................... 18 
3 Components ................................................................................................................................................................ 19 
Preparation before use.............................................................................................................................. 20 
1 Patient Preparation.......................................................................................................................................... 20 
2 How to Use .................................................................................................................................................................. 20 
3 Environment setting ............................................................................................................................................... 24 
4 Frequently used functions ................................................................................................................................... 25 
How to store and manage after use ................................................................................................... 26 
Alarm messages ............................................................................................................................................ 27 
1 Over Temperature .................................................................................................................................................... 27 
2 Transducer Error ....................................................................................................................................................... 28 
Technical specifications ............................................................................................................................ 29 
1 Size and weight ......................................................................................................................................................... 29 
2 Magnetic field strength ........................................................................................................................................ 29 
3 Protocol provided (electromagnetic field) ................................................................................................. 29 
4 Stimulation frequency ........................................................................................................................................... 29 
5 Stimulation Pulse Width ....................................................................................................................................... 29 
6 Classifications ............................................................................................................................................................. 29 
EMC emissions and immunity ................................................................................................................ 30 
FAQ ................................................................................................................................................................... 35 
Maintenance ................................................................................................................................................ 36 
1 Cleaning procedure .............................................................................................................................................. 36 
2 Routine inspection of equipment ................................................................................................................. 36 
3 Safety inspection ................................................................................................................................................... 37 
4 Troubleshooting ..................................................................................................................................................... 38 
5 Regular inspection for performance maintenance .............................................................................. 39 
6 Warranty .................................................................................................................................................................... 39 

 
Page 4 of 42  EN109-3442204-40 IFU 
12. Contact information................................................................................................................................. 41 
 
List of figures 
Figure 1. Main Components ............................................................................................................. 13 
Figure 2. Power cable connection .................................................................................................... 15 
Figure 3. Front view .......................................................................................................................... 16 
Figure 4. Rear view ............................................................................................................................ 17 
Figure 5. Controls .............................................................................................................................. 18 
Figure 6. Transducer .......................................................................................................................... 19 
Figure 7. Power Cable ....................................................................................................................... 19 
Figure 8. Over Temperature Messages ............................................................................................ 27 
Figure 9. Transducer Error Messages ............................................................................................... 28 
 
List of tables 
Table 1. Definitions of Symbols .......................................................................................................... 7 
Table 2. Self-troubleshooting ........................................................................................................... 38

Page 5 of 42 EN109-3442204-40 IFU

1. Information on safety

1.1 Definitions of symbols

• When there is specific information in the Instructions for use that needs to be emphasized for

safety, the following terms and symbols are indicated. All warnings and precautions shall

always be observed.

• The manufacturer or agent of the product is not responsible for any personal/material damage

caused by erroneous use, operation for purposes other than its intended objective and

negligence of product maintenance.

Warning

“Warning” symbol is used to indicate a life-threatening risk

to the operator if the warning is disregarded.

Caution

“Caution” symbol is used to indicate that injury or damage

can be caused if the caution is disregarded.

No pushing

To prohibit pushing against an object

No sitting

To prohibit sitting on a surface

BF Type

Applied part BF type

Instructions for use

To signify that the instruction for use must be read

Electronic

instructions for use

Electronic instructions for use on CD-ROM

Model

Reference number

Serial number

Page 6 of 42 EN109-3442204-40 IFU

Manufacturer

Authorized

representative

Authorized representative in the European Union

Importer

Distributor

Date of

manufacture

Date of manufacture

Stacking limit

number

To indicate that the items shall not be vertically stacked beyond

the specified number, either because of the nature of the

transport packaging or because of the nature of the items

themselves.

Keep away from

rain

To indicate that the transport package shall be kept away from

rain and in dry conditions.

Fragile

To indicate that the contents of the transport package are

fragile and the package shall be handled with care.

This way up

To indicate correct upright position of the transport package.

Recycling

To indicate the location of a recycling bin or container.

“OFF” (Power)

To indicate disconnection from the mains, at least for mains

switches or their positions, and all those cases where safety is

involved.

“ON” (Power)

To indicate connection to the mains, at least for mains switches

or their positions, and all those cases where safety is involved.

Alternating current

To indicate on the rating plate that the equipment is suitable

for alternating current only to identify relevant terminals.

WEEE

Indicates that when the end-user wishes to discard this

product, it must be sent to separate collection facilities for

recovery and recycling.

Page 7 of 42 EN109-3442204-40 IFU

Temperature limit

To indicate the maximum and minimum temperature limits at

which the item shall be stored, transported or used.

Humidity

limitation

To indicate the acceptable upper and lower limits of relative

humidity for transport and storage.

Atmospheric

pressure

limitation

To indicate the acceptable upper and lower limits of

atmospheric pressure for transport and storage.

Dangerous

Voltage

To indicate hazards arising from dangerous voltages.

Equipotentiality

To identify the terminals which, when connected together,

bring the various parts of an equipment or of a system to the

same potential, not necessarily being the earth (ground)

potential, e.g. local bonding.

TABLE 1. DEFINITIONS OF SYMBOLS

Page 8 of 42 EN109-3442204-40 IFU

1.2 Requirements for safety

1.2.1 Warning

• The following patients cannot be treated with this equipment, unless expressly approved

by the doctor in charge before the procedure:

o High blood pressure patients.

o Pregnant women and infants.

o Heart disease (especially those with pacemakers).

o People with acute illness.

o A person who has implanted implants in the body, such as an artificial hip joint.

o Do not use on patients with conductive, ferromagnetic or other magnetically sensitive

metals in the vicinity of the head or treatment coil. (e.g. cochlear implants, implanted

electrodes/stimulators, aneurysmal clips or coils, stents, deep brain stimulators, vagus

nerve stimulators, bullet shards, jewelry or hairpins, etc.)

1.2.2 Notes on targets of use, age or health status, etc., taking into account the characteristics of

medical devices

• The following patients must obtain permission from their doctor before the procedure;

o High fever patients, pregnant women and the elderly.

o Patients with a history or condition of epilepsy or seizure disorder.

o Patients wearing artificial pacemakers, drug injection pumps, and hearing aids.

o People who have implants in the body such as artificial hip joints.

• This device should be used for patients who can accurately express and communicate pain

during stimulation. (Can be used for men and women aged 13 to 60 years old. Can be

used for older people over that age according to doctor's prescription).

1.2.3 Precautions for adverse reactions that may occur as a result of the use of medical devices, fatal

side effects due to negligence in use, and accidents

• Pain may occur in the application area.

• If any abnormalities other than the intended phenomena are found during use,

discontinue use immediately and consult your doctor.

• The device must be used under the supervision of a person with a medical-related

professional license or a person who has completed related training.

Page 9 of 42 EN109-3442204-40 IFU

1.2.4 General precautions

• The device must be used according to the Instructions for use.

• Equipment installation and reinstallation must be done by professional personnel

authorized by the supplier.

• Operators and equipment managers must be familiar with the Instructions for use, and

keep the Instructions for use in close proximity to the equipment.

• Do not place the ME equipment in a location where it is difficult to remove the power plug

or other removable plug.

• For safety accident prevention and proper maintenance, keep safety signs and information

provided with the equipment, and regular checklists in a well-visible place around the

equipment.

• Keep the area where the equipment is installed free of water, alcohol, and flammable

substances.

• For electrical safety, the device must be connected to a safety grounded power source.

• To prevent unintended phenomena, keep the device away from direct sunlight or strong

electromagnetic fields.

• When the equipment is in operation, do not use cell phones, walkie-talkies, portable

wireless transmitters, and wireless toys in the vicinity.

• Since the main body is equipped with a fan for internal air circulation, remove curtains or

other objects that may block airflow from around the machine.

• A strong magnetic field is generated around the magnetic field generator, so when

operating the equipment, the operator, assistant, and patient should not carry any

belongings that may be affected by the magnetic field.

• No other than the professional personnel authorized by the supplier cannot repair or

install the equipment, so it is absolutely forbidden for the user to arbitrarily disassemble

and assemble the equipment.

• Equipment in installation and operation must be regularly inspected for safety by qualified

personnel authorized by the supplier.

• Check whether the power supply at the installation site meets the input conditions of the

device.

• The equipment is only operated indoors where temperature: 5 – 28 ℃, humidity: 30 – 75 %

R.H. are maintained.

Page 10 of 42 EN109-3442204-40 IFU

1.2.5 Interaction

• Do not use in combination with other electronic medical devices.

1.2.6 Use for pregnant women, lactating women, women of childbearing potential, newborns, infants,

children and the elderly

• Pregnant or nursing women, newborns, infants, and children are prohibited.

1.2.7 Application Notes

• Use care so that magnetic stimulation does not penetrate the heart area.

• You should review your patient’s current or past drug resistance level.

• Before using the device, check the connection status of the wires and connectors

connected to the device, damage status, and surface status of accessories to confirm that

there is no problem before use. If damage occurs, you should contact the service center.

• A strong magnetic field is generated around the magnetic field, so equipment operators,

surgeons, assistants, and patients should not all carry any belongings that may be affected

by the magnetic field. In particular, if a patient has metallic accessories (EX: necklaces,

earrings, watches, rings, metallic belts, belt buckles, metallic buttons, etc.) on the human

body, it may cause burns, so be sure to remove them before proceeding.

• Wristwatches, cell phones, etc., if affected by magnetic fields, may cause malfunctions, so

be careful and store them separately.

• Do not use cell phones, walkie-talkies, portable radio transmitters, and wireless toys in the

vicinity while the device is in operation.

• You must inform them of the dangers of long-term use of the device.

Page 11 of 42 EN109-3442204-40 IFU

1.2.8 Matters necessary for prevention of safety accidents

• As the equipment cannot be repaired except by specialized personnel authorized by the

manufacturer, it is absolutely forbidden to disassemble or assemble the equipment by the

user.

• The supplied equipment and accessories should not be used for any other purpose as it

may cause a risk of electric shock if used for any purpose other than the intended use of

this equipment.

• This device must not be operated by children.

• If the equipment does not operate normally during equipment operation, immediately

turn the main power switch 'OFF' and contact a designated service company.

• This device is a medical device for use in professional health care facilities and should only

be handled by trained personnel under the guidance of a physician.

1.2.9 Side effects

• Muscular pain,

• Muscle spasm,

• Temporary joint pain,

• Tendon pain,

• Local circulation,

• Skin redness.

1.3 Safety device

• When a magnetic field is output, a buzzer sounds periodically to notify you that the

magnetic field is being output.

• When the mode is changed or the power is turned on, the output always starts from “0”.

1.4 Contraindication

• Do not use the equipment in parallel with other electronic medical equipment.

• Be careful to ensure that magnetic stimulation does not penetrate the heart region.

• In general, patients in the following categories cannot be treated with this equipment.

Prior to any treatment with this equipment, permission of the doctor in charge must be

obtained:

o Patients with high fever, pregnant women, the elderly and children.

o Patients with a history or status of epilepsy or seizure disability.

o Patients with suspected status of epilepsy on the basis of electroencephalography.

o Patients with evidence of external wound at brain and neck.

o Patients with cardiac pacemakers, drug injecting pumps or hearing aids.

o Patients with cranial implants.

Page 12 of 42 EN109-3442204-40 IFU

2. High induction magnetic field

2.1 Principle

The transducer which is used to magnetic stimulation makes electrical fields by pulse current flowing

from a capacitor according to the principle of Faraday's Law. Whenever the capacitor bank is discharged

by the action of the control system, a pulse of current flows through the stimulating coil. The magnetic

stimulation creates intense, rapidly changing magnetic electrical fields that are able to penetrate soft

tissue and bone, to reach deep nervous structures. This magnetic electrical fields is used to the treatment.

This device directly generates (induces) electric current in muscles, nerve tissues, etc. affected by a high

induction magnetic field and electrically stimulates it to relieve pain and suppress dysuria such as urinary

incontinence.

2.2 Intended use

The COMPACT-II is an electrically powered device intended for medical purposes that repeatedly

contracts muscles by passing electrical currents through electrodes non-contacting the affected

body area. And, in addition, the electro-magnetic stimulator is intended to provide entirely non-

invasive electromagnetic stimulation of pelvic floor musculature for the purpose of rehabilitation of

weak pelvic muscles and restoration of neuromuscular control for the treatment of urinary

incontinence in human.

2.3 Device description

The COMPACT-II is intended to help relieve the patient’s muscular pain and suppress urination such

as urinary incontinence and has the function of magnetic stimulation. This COMPACT-II consists of

the main body and transducer for magnetic stimulation. The function of magnetic stimulation is

operated with the parameter such as Mode, Intensity and Time. These parameters can be controlled

by users on the LCD touch screen.

Page 13 of 42 EN109-3442204-40 IFU

3. Installation

3.1 Components

Main body

Transducer

Power Cable

Instructions for use

FIGURE 1. MAIN COMPONENTS

3.2 Electrical installation condition

• Input power : 220-240 V~, 50/60 Hz

• Power consumption : 1.5 kVA

Page 14 of 42 EN109-3442204-40 IFU

3.3 Environmental condition

3.3.1 Operation environment

• Temperature : 5 – 28 ℃ (41 - 82.4 ℉)

• Humidity : 30 – 75% R.H.

• Pressure : 80 - 106 kPa

3.3.2 Transport and Storage environment

• Temperature : -10 – 60 ℃ (-14 – 140 ℉)

• Humidity : 0 – 85 % R.H.

• Pressure : 70 - 106 kPa

3.4 Installation method

3.4.1 Precautions during installation

• Install the equipment on a flat surface.

• Install the equipment in a location with appropriate ambient temperature and humidity,

and do not install in a location where it will be exposed to dust or flammable materials.

• Be careful not to damage the equipment by excessive shock.

• Do not place the ME equipment in a place where it is difficult to operate the power plug

separation means.

3.4.2 Connection of power

• Do not connect power until equipment installation has been completed.

• Plug the power cable into the power terminal on the back of the COMPACT-II and connect

the other end to a grounded power socket.

• Make sure that the power socket and power cable are grounded before use.

• Check that the power cable is properly connected to the machine's power terminal and

power socket. Incorrect connections can cause problems.

• When disconnecting the power cable, hold the plug when disconnecting.

• Do not connect multiple devices to a single power outlet.

Page 15 of 42 EN109-3442204-40 IFU

• Connect the power cable to the power terminal of COMPACT-II as shown below and

connect the other end to a grounded power socket.

FIGURE 2. POWER CABLE CONNECTION

Warning

To prevent the danger of electrical shock, connection shall be

made to a protected and grounded power supply.

3.4.3 Moving and fixing of the equipment

• Before moving the equipment, remove the connected power cable and the connection

cables for peripheral equipment.

3.4.4 Transducer

• COMPACT-II is a device that generates a magnetic field by applying a strong current to a

transducer. Because heat is generated in the transducer due to the strong current used to

create the magnetic field, cooling is performed by operating a cooling fan inside the

transducer. If the upper vent of the transducer is covered with a cloth, cooling may not be

performed smoothly, resulting in injury or shutdown due to overheating the transducer.

Caution

Do not block the top of the transducer.

Page 16 of 42 EN109-3442204-40 IFU

4. Product description

4.1 External view

4.1.1 Front view

FIGURE 3. FRONT VIEW

No.

Name

Function

1

(LCD) Touch Screen

A display unit that operates the device using touch or

displays the device's operating status

2

Transducer connector

Page 17 of 42 EN109-3442204-40 IFU

4.1.2 Rear view

FIGURE 4. REAR VIEW

No.

Name

Function

1

Coil cooling outlet

Vents for air circulation

2

Power switch

Power ON/OFF switch

3

Power input terminal

AC power inlet

4

Ground terminal

Equal power ground connection

Page 18 of 42 EN109-3442204-40 IFU

4.2 Controls

FIGURE 5. CONTROLS

No.

Name

Function

1

MODE display window

Screen that changes according to the selected mode

2

MODE selection window

Screen to select mode

3

SETTING button

Configuration button

4

Setting time display

window

Display set time and remaining time

5

Intensity setting window

Adjusts the strength of the set mode

6

Transducer display screen

-

7

Mode or time selection

button

After selecting the mode or time, use the up and down

buttons to adjust

8

START / STOP Button

Magnetic field output and stop button

Page 19 of 42 EN109-3442204-40 IFU

4.3 Components

4.3.1 Transducer

FIGURE 6. TRANSDUCER

No.

Name

Function

1

COOLING FAN

Cooling fan for air circulation inside the transducer

2

HV cable

High voltage output cable

3

Magnetic field output

Output part where the magnetic field of the coil is output

4.3.2 Power cable

FIGURE 7. POWER CABLE

No.

Name

Function

1

Power Cable

The cable that supplies power to the Main Unit

Page 20 of 42 EN109-3442204-40 IFU

5. Preparation before use

5.1 Patient Preparation

For hygiene reasons, the treatment area of the patient’s body and the device are not in direct contact.

There is no need to undress when using this device.

Please prepare some fabric towels to be placed on the treatment area of patient body for hygiene

purpose. We recommend cotton towels or covering materials to be applied before treatment starts.

5.2 How to Use

1. When the power switch on the back of the device is “ON”, it is converted to the main screen as

shown in the figure below.

2. There are Auto and Manual Mode for operation mode. Auto Mode provides set parameter

values, and Manual Mode allows users to specify values within the given parameter range.

3. Select the mode you want to implement by using the Mode selection buttons. Choose the

Programs button for Auto Mode and the Favourites button for Manual Mode.

4. Move the transducer to the treatment area.

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