Mettler Electronics Sonicator 719, Sonicator 718 Instruction Manual

Palm-sized Ultrasound
Sonicator® 718 & 719
Instruction Manual
To ensure correct use, please read this manual
carefully before operating the unit.
After reading, store the manual in a safe place for future reference.
Sonicator 718 & 719 Palm-sized Ultrasound
Symbols ������������������������ 2 To Ensure Correct and Safe Use �������������� 3 Intended Use ��������������������� 3 Contraindications ������������������� 3 Precautions ���������������������� 3 Precautions on Use ������������������ 4 Storage and Period of service �������������� 6 Precautions on Handling ���������������� 6 Maintenance and Checkup ��������������� 7 Battery ������������������������ 9 Device Configuration ������������������ 10 Main Unit and Standard Accessories ����������� 10 Optional Accessories ������������������ 10 Specifications ��������������������� 11 Names of Component Parts ��������������� 12 Preparations before Use ����������������� 13 Operating Procedures ������������������ 16 Storage ������������������������ 21 Configuration Setting ������������������ 22 Error Screen ���������������������� 24 EMC ������������������������� 25
1
Sonicator 718 & 719 Palm-sized Ultrasound
Symbols
• Symbol for “CAUTION”
• Symbol for “CONSULT INSTRUCTIONS FOR USE”
• Symbol for “Ultrasound radiation warning sign” by Canadian ultrasound therapy devices standard
• Symbol for “Waste Electrical and Electronic Equipment (WEEE), Directive 2002/96/EC” * This symbol is only valid
in European Union.
• Symbol for “TYPE BF APPLIED PART”
• Symbol for “NON-IONIZING ELECTROMAGNETIC RADIATION”
Shipping Damage and Warranty Registration
Your new Sonicator 718 / 719 is shipped complete in one carton. Upon receipt, please inspect the carton and the unit for visible and hidden damage. If you discover any damage, hold all shipping materials, including the carton, and call the shipping agent who delivered the unit. They are responsible for all damage in transit; therefore, all claims should be led directly with them. The factory will not be responsible for any damage in shipment, nor allow any adjustments unless proper formal claim has been led by the receiver against the carrier.
The carton in which your new Sonicator 718 / 719 was received is specially designed to protect the unit during shipping. Please retain all shipping materials in the event that you will need to return your unit for servicing. NOTE: All warranty repairs are to be performed by Mettler Electronics Corp. or an authorized Mettler Electronics warranty repair center.
Once you have veried proper functioning of your Sonicator 718 / 719, please go online to www. mettlerelectronics.com to register your product.
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Sonicator 718 & 719 Palm-sized Ultrasound
To Ensure Correct and Safe Use
RX Only—This unit should be used by a licensed medical practitioner.
Intended Use
Indications for therapeutic ultrasound can be achieved through thermal effects.
1) Relief of pain
2) Reduction of muscle spasms
3) Localized increase in blood flow
4) Decrease of joint contractures
Contraindications
1) Over the uterus during pregnancy
2) Over thoracic area to patients with cardiac pacemakers
3) Over the site of any implanted electronic devices
4) To eyes
5) Over the heart
6) Area of diagnosed or suspected malignancy
7) To reproductive organs such as testes
8) Regions with thrombophlebitis, deep vein thrombosis, or embolism
9) Over tissues recently treated by deep X-ray or other radiation
10) Over stellate ganglions
11) Over area with impaired circulation
12) Over area with impaired sensation especially when using continuous thermal ultrasound
13) Bone growth centers (active epiphysis) in children until bone growth is complete
14) Patients with cognition or communication impairments not being able to give accurate and timely feedback during treatment
15) Over open wounds
16) Over implants that contain plastic or cement
17) Patients with serious infection such as tuberculosis
18) Over acute inflamed tissue especially when using continuous thermal ultrasound
19) Over active bleeding tissue or patients with untreated hemorrhagic disorders
20) Areas near myositis ossificans
21) Over anterior neck or carotid sinus
Precautions
1) Patients with hemorrhagic diatheses or bleeding disorders
2) Use moving technique of applicator
3) Heating of joint capsules in acute or subacute arthritis should be avoided
4) Electric treatment tables or whirpools which may come in contact with the patient
should be adequately grounded.
3
Sonicator 718 & 719 Palm-sized Ultrasound
To Ensure Correct and Safe Use
5) Over healing fracture
Therapeutic ultrasound may delay or prevent callous formation in a healing fracture
6) Spinal cord after laminectomy
7) Superficial peripheral nerves
8) Burns may occur in following application of therapeutic ultrasound
① High intensity ② Stationary technique ③ Moving sound head too slowly ④ Treating area with sensory nerve damage ⑤ Desensitized areas for example in patients with diabetes, neural damage, and etc ⑥ Bony prominences are especially vulnerable
Precautions on Use
1. General precautions
1) Do not use component parts from any other therapeutic devices with this device.
2) Handle the ultrasound head with great care. Mishandling may affect performance
characteristics.
3) Follow the instructions given below when installing the device.
① Install the device in a location not subjected to atmospheric pressure, temperature,
humidity, ventilation, sunlight, dust, salinity, air containing sulfur or other chemicals.
② Avoid flammable atmospheres, including flammable anesthetic gas mixed with oxygen,
nitrous oxide and air, or flammable disinfectant or cleanser mixed with air. ③ Avoid locations where chemicals are stored or where vapors may be present. ④ Avoid installing the device near flames. Doing so may result in accidents due to
damage or deformation of the device. ⑤ Note the frequency, voltage and allowable current (or power consumption) of the AC
Adaptor. ⑥ Connect the AC Adaptor for the device to an exclusive outlet or battery pack with the
charged battery.
2. Precautions before use
1) Carefully review the patient’s diagnosis and prescription for contraindications,
precautions, and instructions.
2) Make sure the patient gives the operator adequate and timely feedbacks when he or
she has unusual sensations (e.g., pain, heat sensation or pressure) or the device doesn’t work properly during treatment with this device.
3) If the patient reports abnormal pain or heat, stop treatment and determine whether the
sensations goes away. A problem may have occurred or heat may have built up in the patient’s body. If so, burns may result if treatment is continued even at reduced output.
4) Use caution when using the device for the following patients or areas of the body.
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Sonicator 718 & 719 Palm-sized Ultrasound
① Carefully select the output level and duration when treating facial areas. ② When using the device on a child according to a physician’s prescription, take great
care when treating bony regions that no irritations occur. ③ If the individual has had radiation therapy in recent days, be careful in determining
whether the treatment is appropriate for the individual. The inactivated tissue may be
activated by the treatment. ④ Make sure the individual to be treated is free of contagious disease or conditions,
since these can be transmitted to other individuals via the device. ⑤ Determining treatment intensity can be problematic with babies or infants (aged 6 or
under), patients with senile dementia, or other patients who for any other reason are
unable to express their preferences. Proceed carefully before deciding whether to use
this device on such patients.
5) Check battery status (e.g., remaining charge). Use only the battery specified.
6) Check switches and keys to confirm that the device is working properly.
7) Make sure the cables are correctly connected and safely configured.
8) Make sure that the ultrasound head is clean and free of any cracks.
3. Precautions during use
1) With any complaint of periosteal pain from the patient, intensity should be reduced.
2) Make sure the treatment time and intensity do not exceed the suitable range for
treatment purpose.
3) Monitor the device and the patient constantly to ensure no problems arise. In the event
of any problem, take appropriate measures (e.g., shutting down the device in a manner safe for the patient) and contact the dealer, manufacturer or distributor.
4) To prevent accidents, make sure the patient does not operate or touch the device.
5) Make sure the ultrasound head is positioned correctly on the treatment area. Incorrect
positioning can affect effectiveness and results.
6) Do not leave the device with the output turned on. Buildup of heat may damage the
device.
7) If the metal of the ultrasound head or the gel causes any rash, areas of redness,
itching, or other such symptoms, or if the patient feels any abnormality, immediately stop using the device and take adequate measures.
8) Never touch the parts of the device other than the Main Unit, such as the Intermediate
box, with wet hands.
9) Avoid operating Sonicator 718 or Sonicator 719 adjacent to and simultaneously with any
shortwave or microwave devices.
4. Precautions after use
1) Turn off power, and disconnect the power cable from the outlet according to the steps
specified.
2) When disconnecting the AC Adaptor from the outlet, make sure power of the device
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Sonicator 718 & 719 Palm-sized Ultrasound
To Ensure Correct and Safe Use
is off and grasp the adaptor by the plug. Avoid pulling with excessive force when disconnecting cables.
3) Rinse the ultrasound head with lukewarm water lightly and thoroughly wipe dry. Take
adequate measures to ensure it remains clean in storage.
4) Keep the device and accessories clean to avoid inconvenience for the next therapy
session and store in a safe place.
Storage and Period of service
1. Storage
1) Follow the instructions given below when storing the device to avoid malfunctions. ① Avoid locations where the device will be subject to splashing water. ② Avoid locations where the device may be unduly affected by atmospheric pressure,
temperature, humidity, ventilation, sunlight, dust, or airborne salt or sulfur or any other
adverse factors. ③ Make sure the device is kept in a stable position. Avoid tilting the device. Avoid
vibrations and shock. These warnings also apply during transportation. ④ Avoid locations where chemicals are stored or where gas may be generated.
2) If the device will not be used for an extended period of time, remove battery from the
Battery Case and disconnect the AC Adaptor from the outlet.
2. Period of service
Service life: Five years (self-certified) based on our data
Precautions on Handling
1) Do not hit the device against another object, allow it to topple, drop, impose intensive
vibration or impact to it. Even though the device may not exhibit abnormality at the time, damage may advance inside, eventually leading to an accident or malfunction.
2) To dispose consumables and residual materials, as well as the device and accessories
which end of service life has been reached, follow the rules and regulations in force of the area where the device is installed, in order to minimize impact on the environment.
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Sonicator 718 & 719 Palm-sized Ultrasound
Maintenance and Checkup
1. Precautions
1) In the event of a malfunction, do not attempt to repair the device yourself. Attach an
out-of-order notice to the device and contact the dealer, manufacturer or distributor to obtain repair services.
2) Do not attempt to modify the device.
3) Never open the device.
4) When maintaining the Main Unit and accessories, do not clean them with volatile
solvents, such as paint thinner, gasoline, kerosene, or polishing powder, boiling water or chemicals. Such agents could cause discoloration or deterioration. Clean using a cloth impregnated with alcohol, water, lukewarm water or neutral detergent and wrung tightly.
5) The device is waterproof, except for the exception of the intermediate box. Never
attempt to disassemble the device; doing so may affect the waterproof properties or transducer characteristics, resulting in malfunctions.
2. Maintenance and checkup by the user
1) Check the device and accessories on a daily basis to make sure they work properly.
2) If any problem (deteriorated insulation of accessories, damage to the cord coverings,
cracks, early signs of wire breakage, poor connection of connectors, etc.) is detected in the preparatory checkup, be sure you contact your dealer or the manufacturer or distributor.
3) Refer to the following section on Maintenance and check items for daily checkups.
4) When using the device after an extended period of disuse, check to ensure beforehand
that the device works properly and safely.
3. Maintenance and checkup by a contractor
1) To maintain the performance and ensure safe use, request a periodic check from your
dealer or the manufacturer or distributor (once a year as a rule of thumb).
2) Replace consumable parts (including accessories) periodically to prevent problems
occurring in the accessories or device during use.
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Sonicator 718 & 719 Palm-sized Ultrasound
To Ensure Correct and Safe Use
4. Maintenance and check items
Perform periodic inspections to ensure safety. If you have any questions, contact the dealer or manufacturer or distributor.
Item Description Method
Appearance and
indications
Operation
Output
Ultrasound head
The following accessories for Sonicator 718 and Sonicator 719 are replaceable. Call Mettler Electronics Corp. at 800-854-9305 to place an order.
7181 AC Adaptor (100–240 V) 7183 Power Cable for AC Adaptor
7188 Battery Case 7185 Battery Charger 7187
7184 Rechargeable Battery 7191 Pouch
Check the appearance for any signs of damage; whether the display panel is distorted; and whether the indications flicker. Make sure the ultrasound head is clean.
Turn the POWER switch on and check that the device operates normally and exhibits no problems.
Place water on the ultrasound head and turn on the output. Examine the water drops to assess the vibrations.
Check for cracks in the ultrasound head or problems with the cable connection that may permit water or gel to enter the device.
7189 Unit Stand
(110–120 V, only U.S.A & CANADA, Type B)
Power Cable for Battery Charger (110–120 V, only U.S.A & CANADA, Type A)
7180 7190 1844 Sonigel (12 X 9.5 oz. tubes) 1851 Sonigel (12 X 250 ml bottles) 1852 Sonigel (1 X 5 L) 1853 Sonigel (4 x 1852) 1863 Sonigel Lotion with Aloe Vera (1 G) 1864 Sonigel Lotion / Aloe Vera (4 X 1 G)
Protective Cap for Sonicator 718 Probe Protective Cap for Sonicator 719 Probe
Check
visually.
Check by
operating.
Check by
operating.
Check
visually.
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Sonicator 718 & 719 Palm-sized Ultrasound
Battery
Do not charge the battery in the following locations:
1) Ambient temperature is below 0°C or exceed 40°C. (If ambient temperature is too high
or too low, the battery may not charge.)
2) The location is humid, dusty, or subject to vibrations. (The battery may not charge
properly.)
Be sure to use the specified battery.
Specifications: Lithium ion battery, 7.4 VDC (Model No.: 2UR18650F <D-0824Li>) Contact the dealer or manufacturer or distributor to place orders.
Charging
1) The battery is a consumable. If the battery begins to lose power quickly even when
charged for a long time, replace with a new battery.
2) The battery will self-discharge. This means a battery will gradually lose its stored charge
even when not in use. A brand new battery with low or no charge does not indicate a defect.
3) The battery will not malfunction even if overcharged.
4) Be sure to use the specified Battery Charger. (Model No.: NC-L8C17 <D-0824Chg>)
Handling the battery
Do not attempt to disassemble the battery.
Recycling the battery
1) The device uses a lithium ion battery.
2) Lithium Ion Batteries are recyclable resources. Do not discard used batteries. Take
them to a specified location capable of recycling them properly.
3) Avoid discarding used batteries as ordinary waste.
4) Comply with all local rules and regulations to minimize environmental impact.
Notes on recycling
Be careful to avoid short circuits. A battery short circuit may result in fire or electric shock.
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Sonicator 718 & 719 Palm-sized Ultrasound
Device Configuration
Main Unit and Standard Accessories
Main Unit
Sonicator 718 Sonicator 719
order # ❶7180 Protective Cap for Sonicator 718 Probe ❷7190 Protective Cap for Sonicator 719 Probe ❸1844 Sonigel tube ❹7181 AC Adaptor (100–240 V) 7183 Power Cable for AC Adaptor
(110–120 V, only U.S.A & CANADA, Type B)
Optional Accessories
order # ❺7185 Battery Charger
Caution��In the event that the gel has been accidentally drunk, consult a physician immediately. Should the gel get into the eyes, wash the eyes with copious amounts of water, and consult an ophthalmologist immediately.
10
7187
❻7184 Rechargeable Battery ❼7188 Battery Case ❽7189 Unit Stand ❾7191 Pouch
Power Cable for Battery Charger (110–120 V, only U.S.A & CANADA, Type A)
Sonicator 718 & 719 Palm-sized Ultrasound
Specifications
Sonicator 718 Sonicator 719
Power supply AC 100-240 V 50/60 Hz or Rechargeable Battery (optional)
Power consumption 50 VA 17 VA
Ultrasound frequency 1.0 MHz ± 10% 3.0 MHz ± 10%
Intensity (max) 2.00 W/㎠ ± 20% continuous or 3.00 W/㎠ ± 20% pulsed
Duty 5%, 10%, 20%, 30%, 40%, 50%, 100%
Pulse frequency 100Hz ± 5%
Timer 30 min. ± 1 min.
ERA
FDA 5.5 cm2 ± 20% 0.9 cm2 ± 20%
BNR
FDA 3.5 ± 30% 3.6 ± 30%
Output stability
Classification Class / Internaly powered equipment, Type BF
Dimensions 134 (H) × 59 (W) × 55 (D) ㎜ 134 (H) × 59 (W) × 60.5 (D) ㎜
Weight 200 g 190 g
Environmental conditions:
Authorization in U.S.A. and Canada
In use 10 to 40℃ 30 to 75% 700 to 1060 hPa
Storage -10 to 60℃ 30 to 95% 700 to 1060 hPa
Transportation -10 to 60℃ 30 to 95% 700 to 1060 hPa
Power fluctuation: ± 20% Variability with time: ± 20%
Temperature Humidity Pressure
INTERTEK LISTED
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Sonicator 718 & 719 Palm-sized Ultrasound
Names of Component Parts
[Front] [Side]
① Output LED ② Display ③ UP switch ④ DOWN switch ⑤ SELECT switch ⑥ START/STOP switch
* The device in this image is Sonicator 718.
⑦ POWER switch ⑧ Connection cable ⑨ Intermediate box ⑩ Ultrasound head ⑪ Device case
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Sonicator 718 & 719 Palm-sized Ultrasound
Preparations before Use
〈Using AC Adaptor〉
Connect the Power Cable for AC Adaptor to the AC Adaptor.
1
Connect the plug for the AC Adaptor to the intermediate box.
2
Connect the plug of the Power Cable for AC Adaptor to the outlet.
3
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Sonicator 718 & 719 Palm-sized Ultrasound
Preparations before Use
〈Battery-powered〉 
Fit the battery into the Battery Charger.
1
Align the parts of the battery and the charger encircled by a dotted line, snap together, and slide the battery in the direction indicated by the arrow.
* Charge the battery before using it for the first time. * Clean the terminals of the battery and the charger from time to time with a dry cotton
swab. If the terminals are not clean, contact failures may result, in which case the device may fail to turn on, turn off abruptly, or fail to fully charge the battery.
* Optional Accessaries
Battery
Battery Charger
14
Connect the Power Cable for
2
Battery Charger to the Battery Charger and connect the cable plug to the outlet.
Sonicator 718 & 719 Palm-sized Ultrasound
The red lamp of the charger will light. This lamp goes out when charging
3
is complete.
[RedlampON] [RedlampOFF]
Remove the battery from the charger and fit the
4
battery into the Battery Case.
Align the parts of the battery and the Battery Case encircled by the dotted line, snap together, and slide the battery in the direction indicated by the arrow.
Battery Case
* Charge the battery before using it for the first time. * Clean the terminals of the battery and the Battery Case from time to time with a dry
cotton swab. If the terminals are not clean, contact failures may result, in which case the device may fail to switch on, switch off abruptly.
Connect the plug for the Battery
5
Battery
Case to the intermediate box.
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Sonicator 718 & 719 Palm-sized Ultrasound
Operating Procedures
Press and hold the POWER switch for
1
approximately one second to turn on power for the device.
2
InitialCheckver
1.0-1.0
[Initial check screen] After the initial check is completed, the
therapy screen will appear.
* If “Error” appears on the screen, see “Error
screen” on page 24.
16
3
P1
1.00
❸Output mode ❹Timer (remaining time) ❺Ultrasound output
5
:
0010
W/cm
%
[Therapy screen]
❶Program No. ❷Battery status
Fully charged
2
Battery Charge
[Battery error]
Once the battery power drops to the lowest level, the battery error screen will appear, and power for the device will shut down automatically. Recharge the battery.
To change the settings on the
4
therapy screen, press the SELECT switch on the therapy screen while output is off.
P1
Program
%
5
P1
10:00
1.00
W/cm
2
P
Sonicator 718 & 719 Palm-sized Ultrasound
[Program setting screen]
Use the UP and DOWN switches to select a program number.
5% 10:00
P1
1.00
* The settings for each program can be changed. As changes are saved in the device,
the program settings for your device may differ from the settings shown above.
* The program settings are saved at the start and end of output.
◀▶ ◀▶ ◀▶ ◀▶
W/㎠
P2
20% 10:00
1.00
W/㎠
30% 10:00
P3
W/㎠
1.00
Press the SELECT switch.
P4
50% 10:00
1.00
W/㎠
P1
Duty
[Output mode setting screen]
5
%
Use the UP and DOWN switches to select an output mode.
P
◀▶
%
5
10
◀▶
%
20
◀▶
%
30
◀▶
%
40
◀▶
%
50
◀▶
%
100
%
P5
100% 10:00
1.00
W/㎠
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Sonicator 718 & 719 Palm-sized Ultrasound
Operating Procedures
Press the SELECT switch.
P1
Time
[Timer setting screen]
10:00
P
If you press the SELECT switch on the timer setting screen or if no
5
key is operated for approximately 10 seconds, the display will revert to the therapy screen.
Use the UP and DOWN switches to set the timer. The time is set between 1:00 and
30:00 in one-minute increments.
18
Use the UP and DOWN switches to set the ultrasound output level.
6
* Ultrasound output levels can be adjusted during output.
Continuous (Duty 100%): 0.10 to 2.00 W/㎠ Pulsed: (Duty 5%, 10%, 20%, 30%, 40%, 50%): 0.10 to 3.00 W/㎠
The level is set within the ranges above in an increment of 0.05 W/㎠ when the output unit is set to W/㎠.
* Note that setting details will differ between Sonicator 718 and Sonicator 719 if the output unit
is set to W.
Apply the Ultrasound Gel
7
to the ultrasound head.
Press the START/STOP switch
8
to initiate output.
Sonicator 718 & 719 Palm-sized Ultrasound
While ultrasound is being output, as long as the ultrasound head is in proper contact with the body, an audible therapy signal will be emitted and the output LED will remain on.
* Any settings except for the program
settings can be edited during output. (See pages 17 to 18.)
* If the ultrasound head is not in proper
contact with the body for approximately 3 minutes, the output will shut off automatically.
* The audible therapy signal is turned on and
off from the Config. screen. (See page 22.)
* If no key operation occurs for approximately
3 minutes, power for the device will shut off automatically.
P1
1.00
5
:
0010
W/cm
%
2
Press the START/STOP switch to end output before the timer runs out.
* The timer will revert to the set time.
LEDON
Thisis displayed during output.
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Sonicator 718 & 719 Palm-sized Ultrasound
Operating Procedures
When the timer reaches “0:00,” the buzzer will sound and the display
9
screen and output LED will start blinking to indicate that therapy is complete.
Press and hold the POWER switch (approximately one second) to turn off power.
Make sure power is off. Wipe to remove the Ultrasound Gel from the
10
ultrasound head.
* Keep the device and accessories clean to avoid inconvenience in the next therapy.
Store in good order in a dry location.
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Sonicator 718 & 719 Palm-sized Ultrasound
Storage
〈Protective Cap〉
Place the cap on the ultrasound head to protect against damage during storage.
[Sonicator 718] [Sonicator 719]
* Wipe all Ultrasound Gel from the ultrasound head. * The Sonicator 718 and Sonicator 719 use different caps.
〈Unit Stand〉
Place the device on the stand to store in a stable position.
*Optional Accessories
UnitStand
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Sonicator 718 & 719 Palm-sized Ultrasound
Configuration Setting
Press and hold the SELECT switch
1
(approximately one second) on the therapy screen while output is off. The Config. screen appears.
Config.
Contrast
15
[Contrast setting screen]
Use the UP and DOWN switches to set the display screen contrast.
Contrast can be set between 0 and 15.
———————
  0          Bright
▶15
22
Config.
KeyTone
ON
Press the SELECT switch.
[Key sound setting screen]
Use the UP and DOWN switches to turn the key touch sound on or off.
 ON ◀▶ OFF
Config.
ContactTone
ON
Config.
W/cm2orW
W/cm
2
Sonicator 718 & 719 Palm-sized Ultrasound
Press the SELECT switch.
[Therapy sound setting screen]
Use the UP and DOWN switches to turn the audible therapy signal on or off.
 ON ◀▶ OFF
Press the SELECT switch.
[Unit setting screen]
Use the UP and DOWN switches to select a unit for output level.
 W/cm2 ◀▶ W
Press the SELECT switch.
Config.
GELorOTM
[GEL/OTM setting screen]
Use the UP and DOWN switches to select GEL or OTM.
GEL
 GEL ◀▶ OTM
Once configuration settings are completed, press and hold the SELECT
2
switch (approximately one second) to return to the therapy screen.
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Sonicator 718 & 719 Palm-sized Ultrasound
Error Screen
Error
If the screen displays the “Error” message, power for the device will be automatically shut down in approximately 10 seconds.
Press and hold the POWER switch (approximately one second) to turn power on once again.
* Contact the dealer or manufacturer or distributor if the “Error” message appears
repeatedly.
* The “Error” message is likely to appear if the device is used near another device: for
instance, a shortwave therapy system or microwave therapy system. In that case, try moving the device away from the other device, then power on once again.
24
Sonicator 718 & 719 Palm-sized Ultrasound
EMC
・ Medical electronic devices are designed to ensure electromagnetic compatibility (EMC).
These devices must be installed and used in accordance with the EMC information
provided in the attached document.
・ Portable and mobile RF communications devices may affect medical electronic devices.
・ Cable length (220–240 V model)
1) Main Unit: 1.5m
2) Battery Case: 0.2m
3) AC Adaptor: 1.5m
4) Power Cable for AC Adaptor: 0.5m
・ If accessories other than those supplied as spare parts by the manufacturer are used,
the emission of this instrument may increase and immunity may be reduced.
・ Do not place this instrument next to or on top of another device when using it. If it has
to be placed next to or on top of another device, check that this instrument and the device function properly before use.
Guidance and manufacturer’s declaration — electromagnetic emissions
The Sonicator 718 and Sonicator 719 are intended for use in the electromagnetic environment specified below. The customer or the user of the Sonicator 718 / Sonicator 719 should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment — guidance
The Sonicator 718 / Sonicator 719 use RF energy
RF emissions CISPR 11
RF emissions CISPR 11
Harmonic emissions IEC 61000-3-2
Voltage fluctuations/ flicker emissions IEC 61000-3-3
Group 1
Class B
Class A
Complies
only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
The Sonicator 718 / Sonicator 719 are 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.
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Sonicator 718 & 719 Palm-sized Ultrasound
EMC
Guidance and manufacturer’s declaration — electromagnetic immunity
The Sonicator 718 and Sonicator 719 are intended for use in the electromagnetic environment specified below. The customer or the user of the Sonicator 718 / Sonicator 719 should assure that it is used in such an environment.
Immunity test
EIectrostatic discharge (ESD) IEC 61000-4-2
EIectrical fast transient/burst IEC 61000-4-4
Surge IEC 61000-4-5
Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11
IEC 60601-1-2
compliance
test level
± 6 kV contact ± 8 kV air
± 2 kV for power supply lines ± 1 kV for input/ output lines
± 2 kV for power supply lines
± 1 kV line(s) to line(s) ± 2 kV line(s) to earth
T
<5%
U
(>95% dip in
for 0.5 cycle
T
40%
U
(60% dip in
U
for 5 cycles
T
70%
U
(30%dip in
U
for 25 cycles
T
<5%
U
(>95% dip in
for 5 sec
level
— guidance
Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %.
Mains power quality should be that of a typical commercial or hospital environment.
Mains power quality should be that of a typical commercial or hospital environment.
Mains power quality should
Electromagnetic environment
T
U
)
be that of a typical commercial or hospital environment. If the user of the
T
)
Sonicator 718 / Sonicator 719 requires continued operation
T
)
during power mains interruptions, it is recommended
T
U
)
that the Sonicator 718 / Sonicator 719 be powered from an uninterruptible power supply or a battery.
Power frequency (50/60 Hz) magnetic field IEC 61000-4-8
NOTE:
26
3 A/m
U
is the a.c. mains voltage prior to application of the test level.
T
Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.
Sonicator 718 & 719 Palm-sized Ultrasound
Guidance and manufacturer’s declaration — electromagnetic immunity
The Sonicator 718 and Sonicator 719 are intended for use in the electromagnetic environment specified below. The customer or the user of this unit should assure that it is used in such an environment.
Immunity test
IEC60601-1-2
test level
compliance
level
Electromagnetic environment — guidance
Portable and mobile RF communications equipment should be used no closer to any part of this unit. including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
Recommended separation distance
Conducted RF IEC 61000-4-6
3Vrms 150kHz 〜 80MHz
3Vrms
d = 1.2 P 150kHz to 80MHz d = 1.2 P 80MHz to 800MHz d = 2.3 P 800MHz to 2.5GHz
where P is the maximum output power rating of the transmitter in watts (W) according to
Radiated RF IEC 61000-4-3
3V/m 80MHz 〜 2.5GHz
3V/m
the transmitter manufacturer and d is the recommended separation distance in metres (m).
Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,a should be less than the compliance level in each frequency range.
b
Interference may occur in the vicinity of equipment marked with the following symbol:
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is 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 Sonicator 718 / Sonicator 719 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the Sonicator 718 / Sonicator 719.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
27
Sonicator 718 & 719 Palm-sized Ultrasound
EMC
Recommended separation distances between portable and mobile RF
communications equipment and this unit
The Sonicator 718 and Sonicator 719 are intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Sonicator 718 / Sonicator 719 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Sonicator 718 / Sonicator 719 as recommended below, according to the maximum output power of the communications equipment.
Rated maximum
output power of
transmitter
W
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 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.
Separation distance according to frequency of transmitter m
150kHz to 80MHz
d = 1.2
P
80 MHz to 800 MHz
d = 1.2
P
800 MHz to 2.5 GHz
d = 2.3
P
28
1333 South Claudina Street Anaheim, CA 92805 U.S.A. Toll Free: 800-854-9305 TEL: 1-714-533-2221 FAX: 1-714-635-7539 URL: http://www.mettlerelectronics.com E-Mail: mail@mettlerelectronics.com
IR8-36 Rev.B_06/26/12
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