RootZXmini Operation K199-81002-500 20181021 en
RootZXmini Operation K199-81002-500 20181021 en
RootZXmini Operation K199-81002-500 20181021 en
Root ZX mini
Operation Instructions
1 Operation 2018-10-21
Inspection and Warranty 26
Maintenance and Inspection Items 26
Warranty 27
Troubleshooting 28
Technical Specifications 30
Specifications 30
Symbols 31
Electromagnetic Disturbances (EMD) 32
Operation 2018-10-21 2
Prevent Accidents
Attention Customers
Do not fail to receive clear instructions concerning the various ways to use this equipment as de-
scribed in this accompanying Operation Instructions.
Fill out and sign the warranty and give the dealer from whom you purchased the equipment his
copy.
Attention Dealers
Do not fail to give clear instructions concerning the various ways to use this equipment as de-
scribed in this accompanying operator’s manual.
After instructing the customer in the operation of the equipment, have him fill out and sign the war-
ranty. Then fill in your own section of the warranty and give the customer his copy. Do not fail to
send the manufacturer’s copy to J. MORITA MFG. CORP.
Prevent Accidents
Most operation and maintenance problems result from insufficient attention being paid to basic
safety precautions and not being able to foresee the possibilities of accidents. Problems and ac-
cidents are best avoided by foreseeing the possibility of danger and operating the equipment in
accordance with the manufacturer’s recommendations. First thoroughly read all precautions and
instructions pertaining to safety and accident prevention; then, operate the equipment with the
utmost caution to prevent either damaging the equipment itself or causing bodily injury.
The following symbols and expressions indicate the degree of danger and harm that could
result from ignoring the instructions they accompany:
This warns the user of the possibility of extremely serious injury or complete destruc-
tion of the equipment as well as other property damage including the possibility of fire.
This warns the user of the possibility of mild injury or damage to the equipment.
The warning symbols ( ) and caution symbols ( ) that appear next to the main text on the
right hand side of the page refer to and are explained by the Warnings and Cautions at the bottom
of the page.
This alerts the user of important points concerning operation or the risk of equipment
damage.
The user (e.g., healthcare facility, clinic, hospital etc.) is responsible for the management, mainte-
nance and use of medical divice.
This equipment must only be used by dentists and other legally licensed professionals.
Do not use this equipment for anything other than its specified dental purpose.
3 Operation 2018-10-21
Disclaimer
■■ J. MORITA MFG. CORP. will not be responsible for accidents, equipment damage, or bodily
injury resulting from:
1. Repairs made by personnel not authorized by J. MORITA MFG. CORP.
2. Any changes, modifications, or alterations of its products
3. The use of products or equipment made by other manufacturers, except for those by J.
MORITA MFG. CORP.
4. Maintenance or repairs using parts or components other than those specified by J. MORITA
MFG. CORP. and other than in their original condition
5. Operating the equipment in ways other than the operating procedures described in this man-
ual or resulting from the safety precautions and warnings in this manual not being observed
6. Workplace conditions and environment or installation conditions which do not conform to
those stated in this manual such as improper electrical power supply
7. Fires, earthquakes, floods, lightning, natural disasters, or acts of God.
■■ The useful life of the Root ZX mini is 6 years (based on self-certification) from the date of ship-
ment provided it is regularly and properly inspected and maintained.
■■ J. MORITA MFG. CORP. will supply replacement parts and be able to repair the product for a
period of 10 years after the manufacture of the product has been discontinued. For the duration
of this period, we will supply replacement parts and be able to repair the product.
In Case of Accident
If an accident occurs, the Root ZX mini must not be used until repairs have been completed by a
qualified and trained technician authorized by the manufacturer.
Patient Population
Age Child to Elderly
Weight N/A
Nationality N/A
Sex N/A
• This equipment is not recommended for use in children under 12 years of age.
Operation 2018-10-21 4
Warnings and Prohibitions
* J. MORITA MFG. CORP. is not responsible for any accidents or other types of trouble that are
caused by not following the warnings and prohibitions noted below.
• Accurate canal measurement is not always possible depending on the shape and condition of the tooth as well
as a decline in the equipment’s performance.
• Do not use damaged file holders; an accurate measurement cannot be made with a damaged file holder.
• When a continuous tone is heard while the main power switch is on and without any operation, some electrical
part may be malfunctioning. Do not use the unit and send the unit to J. MORITA OFFICE for repairing.
• A rubber dam should be used when performing endodontic treatment.
• Some care must be taken concerning electromagnetic compatibility (EMC) when using the Root ZX mini. Refer
to the user’s manual and other attached documents for EMC information regarding installation and operation.
• Both portable and movable radio frequency transmitters may have some effect on the Root ZX mini.
• Using replacement parts or accessories not supplied by the original manufacturer could adversely affect the
EMC performance of the Root ZX mini.
• As far as possible, do not use the Root ZX mini near or simultaneously with other devices. If this cannot be
avoided, observe carefully and make sure both the Root ZX mini and the other device operate normally.
5 Operation 2018-02-21
Parts Identification and Accessories
Parts Identification
File Holder
Set Switch
Power Switch
Probe Cord
Accessories
⹅⹅Standard Accessories
Probe Cord File Holder Contrary Electrode Tester Alkaline Dry Cells
(1) (3) (5) (1) (3)
(LR03 (AAA size) batteries)
⹅⹅Optional Accessories
Long File Holder
(1)
Operation 2018-02-21 6
Usage
1. Before Using the Unit
Installing the Batteries
1. Slide the cover in the direction by the arrow in the illus-
tration and remove it from the Root ZX mini.
BAD
• The Root ZX mini is shipped without the batteries installed. Remove the cover and install the 3 LR03 (AAA
size) batteries.
• Do not reverse the plus and minus poles.
• Never allow the spring contact to push against the edge of the battery. This could damage the outer cover
causing a short or a leakage of battery liquid.
• After installation, give the cover a light tug to confirm it is securely attached.
7 Operation 2018-02-21
Connecting the Probe Cord
1. Insert the probe cord completely into the jack on the
left side of the Root ZX mini.
Probe Cord
2. Insert the file holder’s gray male plug into the gray
Connector (white) female connector on the probe cord. Insert the contrary
electrode into the white female connector on the probe
cord.
Contrary Electrode
File Holder Plug
Probe Cord
Connector (gray)
• Handle the Root ZX mini carefully; do not drop, bump or expose the unit to other kinds of impacts or
shocks. Rough handling could cause damage.
• Make sure the probe cord plug is securely plugged into the jack. A poor connection can prevent measure-
ment.
• Do not drop anything on or bang the probe cord plug after it has been inserted into the jack.
• Make sure to match colors of the file holder and contrary electrode to the probe cord.
Measurements cannot be made if these connections are reversed.
• The unit may turn off if its side is bumped.
Operation 2018-02-21 8
Checking the Function
Must be
within
this range
• Check the Root ZX mini operation before each patient. If the indicators in the display do not all appear
normally, the instrument may not be able to make an accurate measurement. In this case, stop using the
instrument and have it repaired.
9 Operation 2018-02-21
2. Operating the Unit
Operating Environments
Temperature: +10°C to +35°C (+50°F to +95°F)
Humidity: 30% to 80% (without condensation)
Atmospheric Pressure: 70 kPa to 106 kPa
* If the unit has not been used for some time, make sure it works properly before using it again.
Flash Bar
Use this line as an estimate for
root canal measurement.
Memory Bar
Power Switch Set Switch
Information Display Use this as an estimate of some
• Standby (file outside canal): intermediate point inside the
Memory Number for Flash Bar canal.
• During Measurement (file inside canal):
Number of bars left before Flash Bar is reached
• When Flash Bar position is being set:
Position of Flash Bar
• Never connect the Root ZX mini to any device not approved by J. MORITA MFG. CORP.
• Never use the unit if the battery power indicator is flashing on and off. The unit may not function properly if
the battery power is low.
• The meter readings 1, 2, and 3 do not correspond to any actual distance and should only be used as esti-
mates.
Operation 2018-10-21 10
Settings
1. Select Memorized Flash Bar
Method
Press Set Switch. Each press of the Set Switch will change
the memory selected in the sequence 01 to 02 to 03 and
then back to 01 again. The Flash Bar set for each memory
will appear when that memory is selected. The memory
selected when the unit is turned off is the one that will be
selected when is it turned back on again.
Method
When the file is not inserted, hold down the Power Switch
Flashes and then press the Set Switch at the same time. Each
press of the Set Switch will move the Flash Bar one bar to-
wards the Apex. The position will be automatically memo-
rized.
11 Operation 2018-02-21
Settings
3. Memory Bar
The Memory Bar can be set anywhere up to APEX.
The Memory Bar can be set during treatment to mark
a point of interest inside the canal such as the begin-
ning of a curve, a certain distance from the apex, or the
File position point to change file size for enlargement.
Method
Insert the file up to the desired point and then press the
Set Switch. This will cause another bar to flash on and off
at a slightly slower speed that the main Flash Bar. This will
not change the point where the alarm is activated.
Memory Bar
starts flashing
4. Beeper Volume
The volume of the beep can be set for Loud or Soft, or
it can be turned off.
Method
Hold down the Set Switch and turn the Root ZX
mini on. This will change the setting of the beep
from Loud to off. Repeat the procedure to change
it from off to Soft. The setting will be memorized
and stay the same the next time you turn the unit
on.
• The Memory Bar should only be used as an estimate. You may need to change it during enlargement and
cleaning. If there seems to be some problem, stop using the instrument immediately.
• Check the settings displayed after selecting memories.
Operation 2018-02-21 12
Meter Display
The position of the file tip is shown by the canal length
indicator bar on the display. The Flash Bar flashes on and
off once file is inserted into the root canal.
Flashes
The meter’s 0.5 reading indicates that the tip of the file is
in or very near the apical constriction.
* The numerals on the meter gauge do not represent mil-
limeters.
Flashes
Flashes
• In some cases such as a blocked canal, a measurement cannot be made. (For details “Root Canals not suit-
able for Electronic Measurement.”)
• Always check the measurement with an X-ray. In some cases, an accurate measurement cannot be made
because of the canal shape, unusual cases, or poor performance of the instrument.
• Stop using the instrument immediately if you sense something odd or abnormal while taking a measure-
ment.
• Do not let the file touch the gums. This will cause the meter to jump to Apex.
• If the canal is extremely dry, the meter may not move until it is quite close to the apex. If the meter does
not move, try moistening the canal with oxydol or saline.
• Occasionally the canal length indicator bar will make a sudden and large movement as soon as the file is
inserted into the root canal, but it will return to normal as the file is advanced down towards the apex.
13 Operation 2018-02-21
Operating the Unit
1. Turn the unit on.
2. Hook the contrary electrode in the corner of the pa-
tient’s mouth.
Contrary Electrode
File or Reamer
Handle
• Do not use an ultrasonic scaler with the contrary electrode attached to the patient. Electrical noise from the
scaler could interfere with canal measurements.
• Make sure that the contrary electrode, file holder etc. do not come into contact with an electric power
source such as an electrical socket. This could result in a severe electrical shock.
• The contrary electrode could cause an adverse reaction if the patient has an allergy to metals. Ask the
patient about this before using the contrary electrode.
• Take care that medicinal solutions such as formalin cresol (FC) or sodium hypochlorite do not get on the
contrary electrode or the file holder. These could cause an adverse reaction such as inflammation.
• Always clip the file holder to the upper part of file shaft, near the handle. The metal and plastic part of the
file holder can be damaged if they are attached to the file’s cutting part or the transition to the cutting part.
Operation 2018-02-21 14
Operating the Unit
GOOD BAD
1 2
Set Switch
5. Insert the file up to the Flash Bar (this point can also be
recognized by the change in the beeping). Position the
rubber stopper on the tooth surface as a reference point
to determine the root canal’s working length. Use the 0.5
reading on the meter to estimate the canal’s length.
Flash Bar
• Use files and reamers with plastic handles only. If the file has a metal handle, electrical leakage will occur
when the handle is touched by fingers and it will prevent an accurate root canal measurement. Even if the
file handle is made of plastic, make sure not to touch the metal part of the file with finger.
• Do not use damaged file holders. An accurate measurement cannot be made using a damaged file holder.
• Clip the file as shown in illustration #1 to the left. If the file is in the position shown in illustration #2, it may
not make a correct measurement and the file holder could be damaged.
• Make sure to take an X-ray to check the results.
• Make sure the long file holder does not prick or pierce the patient’s oral mucosa .
15 Operation 2018-02-21
Root Canal Not Suitable for Electronic Measurement
Accurate measurement cannot be obtained with the root canal conditions shown below.
There may be cases other than these where an accurate measurement cannot be made.
Root Canal with a large apical foramen
Root canal that has an exceptionally large apical foramen
due to a lesion or incomplete development cannot be ac-
curately measured; the results will show shorter measure-
ment than the actual length.
Fractured tooth
Fracture Leakage through a branch canal
Fractured tooth will cause electrical leakage and an accu-
rate measurement cannot be obtained.
A branch canal will also cause electrical leakage.
Branch
Operation 2018-02-21 16
Root Canal Not Suitable for Electronic Measurement
Crown or metal prosthesis touching gingival tissue
Crown
Accurate measurement cannot be obtained if the file
touches a metal prosthesis that is touching gingival tissue.
In this case, widen the opening at the top of the crown so
that the file will not touch the metal prosthesis before tak-
ing a measurement.
Pulp
Blocked Canal
The meter will not move if the canal is blocked.
Open the canal all the way to the apical constriction to
measure it.
Blocked
Too Dry
17 Operation 2018-02-21
Root ZX mini Meter Reading and Radiography
Sometimes the Root ZX mini meter reading and the X-ray image will not correspond. This does not
mean that the Root ZX mini is not working properly or that the X-ray exposure is a failure.
* Occasionally, the actual apical foramen does not correspond exactly. The actual apical foramen
may be located up towards the crown. In these cases, the X-ray image will seem to indicate that
the file has not reached the apex.
X-ray Tube
* Depending on the angle of penetration of the X-ray beam, the apex may not appear
correctly, and the position of the apical foramen may appear to be located differently
than it actually is.
Operation 2018-02-21 18
3. After Using the Unit
1. Turn the unit off.
BAD
BAD
Cord
• Do not pull directly on the cords when connecting or disconnecting the probe and file holder. Always grip
the connectors to connect and disconnect cords.
• Do not wrap the probe cord around the body of the main unit.
19 Operation 2018-02-21
4. Replacing Batteries
Replace the batteries as soon as the battery power indica-
tor starts flashing.
BAD
• Never use the unit if the battery power indicator is flashing on and off. The unit may not function properly if
the battery power is low.
Operation 2018-02-21 20
3. Slide the cover all the way down until it is securely
closed.
• After installation, give the cover a light tug to confirm it is securely attached.
• Always use LR03 alkaline, Oxyride™ , or manganese dry cells. (Manganese dry cells will not last as long as
Oxyride™ or alkaline dry cells.) Never use rechargeable nickel-hydrogen or nickel-cadmium batteries.
• All the dry cells should be of the same type: i.e., all alkaline, all Oxyride™ , or all manganese.
• Replace all three batteries at the same time.
• Never use batteries that are leaky, deformed, discolored or otherwise abnormal.
• Dispose of old batteries according to local codes and regulations.
• In case of battery leakage, carefully dry the battery terminals and remove all of the leaked liquid. Replace
the battery with a new one.
21 Operation 2018-02-21
Maintenance
Be sure to follow the procedure below when performing daily maintenance.
Cleaning Disinfection Packing Sterilization
Cleaning
1. Disconnect the file holder, long file holder and contrary
electrode from the probe cord.
Hook
Operation 2018-02-21 22
Disinfection
Wipe the file holder, long file holder and contrary electrode
with a piece of gauze dampened with Ethanol for Disinfec-
tion (Ethanol 70 vol% to 80 vol%).
Do not immerse the components in or wipe it with
any of the following: functional water (acidic electro-
lyzed water, strong alkaline solution, and ozone water),
medical agents (glutaral, etc.), medicinal solutions (FC:
formalin cresol, sodium hypochloriteor, etc.) or any other
special types of water or commercial cleaning liquids.
Such liquids may result in plastic degradation, metal cor-
rosion and adhesion of the residual medical agent to the
components. If any of these liquids being applied to the
components, wash it off in running water.
Never wipe components with any solution other than Ethanol for Disinfection (70 vol% to 80
vol%). Other solutions could cause cracking and discoloration.
Never wipe components with a piece of gauze that is excessively wet with Ethanol for Disinfection
(Ethanol 70 vol% to 80 vol%). Do not apply or spray with any fluid. Also, do not immerse in any
fluid or wash with water. It could seep inside the instrument and damage it. Be especially careful
around the connection jacks for the transmission cable.
Avoid spilling chemical solutions used for treatment on the any components. These chemicals
could damage, deform or discolor plastic and metal. Use extra caution to avoid spilling formalin cre-
sol (FC) and sodium hypochlorite as they are quite strong. Wipe up any chemical spills immediately.
(Some chemicals may leave traces even if wiped up immediately.)
Use only Ethanol for Disinfection (Ethanol 70 vol% to 80 vol%) and OPTI-CIDE-3™ Surface Wipes
for cleaning. Any other cleaning chemical or products should not be used including but not limited
to the following cleaning products and similar cleaning products listed below because of the poten-
tial damage to the plastic components of the Root ZX mini.
• CaviWipes™ • CaviCide™ • SANI-CLOTH™
* The “™” mark indicates that each trade name is a trademark or registered trademark owned by
the manufacturer in US or other territories.
23 Operation 2018-02-21
Packing
Individually place the file holder or long file holder, and contrary electrode in a sterilization pouch.
Do not put stress on the cable when you place the file holder in a sterilization pouch.
Sterilization
Autoclave the file holder, contrary electrode, and long file holder after use for
each patient.
Recommended temperature and time:
+134°C (+273.2°F), 6 minutes minimum with a sterilization pouch.
Minimum drying time after sterilization: 10 minutes.
or
Recommended temperature and time:
+121°C (+249.8°F), 60 minutes minimum with a sterilization pouch.
Minimum drying time after sterilization: 10 minutes.
• To prevent the spread of serious, life-threatening infections such as HIV and hepatitis B, the file holder, long
file holder, and contrary electrode must be autoclaved after each patient’s treatment has been completed.
• The file holder, long file holder, and contrary electrode are extremely hot after autoclaving; do not touch until
they cool off.
Operation 2018-10-21 24
Replacement Parts, Transport and Storage
Replacement Parts
* Replace the parts as necessary depending on degree of wear and length of use.
* Order replacement parts from your local dealer or J. MORITA OFFICE.
25 Operation 2018-10-21
Inspection and Warranty
• Maintenance and inspection are generally consider to be the duty and obligation of the user, but
if, for some reason, the user is unable to carry out these duties, contact J. MORITA MFG. CORP.
for details.
• Replace the parts listed in the Parts Lists as necessary depending on degree of wear and length
of use.
• This apparatus should be inspected every 6 months in accordance with the following mainte-
nance and inspection items.
⹅ Parts Lists
Operation 2018-02-21 26
Maintenance and Inspection Items
⹅⹅Disposal of Medical Devices
Any medical devices which could possibly be contaminated must be first decontaminated by the
responsible doctor or medical institution and then be disposed of in accordance with local laws and
regulations.
The battery should be recycled. Metal parts of the equipment are disposed as scrap metal. Syn-
thetic materials, electrical components, and printed circuit boards are disposed as electrical scrap.
Material must be disposed according to the relevant national legal regulations. Consult specialized
disposal companies for this purpose. Please inquire of the local administration concerning local
disposal companies.
⹅⹅Service
The Root ZX mini may be repaired and serviced by:
• The technicians of J. MORITA’s subsidiaries all over the world.
• Technicians employed by authorized J. MORITA dealers and specially trained by J. MORITA.
• Independent technicians specially trained and authorized by J. MORITA.
Warranty
⹅⹅1 Year Limited Warranty
1. The manufacturer gives a guarantee for one year beginning from the date of purchase. Within
this period any defect that is due to faulty manufacturing or material will be remedied by repair
or replacement at the manufacturer or its distributor.
2. Warranty repair and service: In the event of a claim under this warranty, the device is to be sent
to the service facility of the distributor, postage and shipping paid, including a short description
of the problem, and a copy of the sales receipt from the dealer as proof of purchase and title to
warranty.
Always ship prepaid. Distributor does not accept collect shipments.
3. In the case of damage caused by wear and tear, careless handling and repairs not carried out
by authorized service facility, the warranty ceases to be valid. This guarantee may not form the
basis for any claims for damages, in particular not for compensation of consequential damages.
The buyer assumes responsibility for damage due to dropping of the unit, improper use and uti-
lization of product and chemicals other than those stated in this instruction manual for cleaning.
It is the customer’s responsibility to maintain the exact rated voltage indicated at the bottom of
the unit, and the office maintains electrical outlets for proper performance of the unit.
4. This warranty does not include the external accessories, file electrode, batteries, or transporta-
tion costs.
27 Operation 2018-02-21
Troubleshooting
If the equipment does not seem to be working properly, the user should first try to inspect and
adjust it himself.
* If the user is unable to inspect the equipment himself or if the equipment fails to work properly
after being adjusted or after parts are replaced, contact your local dealer or J. MORITA OFFICE.
Cannot switch Is a measurement being performed? The memory cannot be changed while the unit is
memories. Does the switch work? making a measurement.
Cannot change Switch may be broken.
memory settings.
Display does not Try replacing the dry cells. If new dry cells do not solve the problem, the
appear. LCD may be malfunctioning.
Canal Length Indica- Is contrary electrode making good Make sure the contrary electrode makes good
tor is unstable. contact with oral mucosa? contact with the oral mucosa.
Is the file holder dirty? Clean the file holder with Ethanol for Disinfection
(Ethanol 70 vol% to 80 vol%).
Canal Length Indica- Is blood or saliva overflowing from If blood or other fluids overflow the canal, the cur-
tor overreacts or is the opening of the crown? rent will leak to the gums and the meter will jump
too sensitive. to Apex. Clean the canal, canal opening and tooth
(Measurements are crown thoroughly.
too short. Poor accu- Is the canal filled with blood, saliva The canal length indicator bar may suddenly
racy. Erratic results.) or chemical solutions? swing when it breaks the surface of fluids inside
the canal, but it will return to normal as the file is
advanced down toward the apex.
Clean entire tooth surface.
Is the tooth surface covered with
cutting debris or chemical solutions?
Is the file touching the gingival tis- This will cause the canal length indicator bar to
sue? suddenly jump all the way to the “APEX”.
Is there pulp tissue left inside the Accurate measurements cannot be obtained if a
root canal? large amount of pulp tissue is left inside the root
canal.
Is the file touching a metal prosthe- Touching a metal prosthesis with the file allows a
sis? flow of current to the gingival tissue or periodon-
tal pocket and will cause the meter to jump to the
“APEX”.
Are proximal surfaces infected with Current can flow through the caries infected area
caries? to the gums and prevent an accurate measure-
ment from being made.
Operation 2018-02-21 28
Problem Check Points Response
Canal Length Indica- Are there lateral canals or is the The canal length indicator bar may jump to “APEX”
tor overreacts or is tooth fractured? when it reaches the opening of a lateral canal or
too sensitive. the opening of a fractured tooth that allows the
(Measurements current to flow to the gingival tissue.
are too short, poor Does a broken crown allow leakage Build up an insulating barrier to stop the leakage.
accuracy or erratic of electric current?
results.)
Is there a lesion at the apex? A lesion can destroy the apical foramen through
absorption and an accurate measurement cannot
be obtained.
Is the file holder broken or dirty? Replace or clean the file holder.
Canal Length Indica- Is the canal blocked? Open the passage all the way through the apical
tor does not move at constriction first and then take the measurement.
all or only when the Is the apical foramen very large and If the apical foramen is large or wide open and not
file tip is close to the open? completely formed, the canal length indicator bar
apical foramen. will suddenly jump when the file tip gets close to
the apex.
Is the canal extremely dry? Moisten the canal with oxydol or a saline solution.
Cannot set Memory Is desired indicator bar lit up? Advance file to desired point.
Bar for file tip at Did you press the Set switch? Press Set switch firmly.
desired point.
Has file tip gone beyond Apex Bar? Move file tip up above the Apex Bar.
29 Operation 2018-02-21
Technical Specifications
Specifications
*Specifications may be changed without notice due to improvements.
Model RCM-7
Intended Use The Root ZX mini is intended to detect the apex of the
root canal.
⹅Essential
⹅Main Performance
Unit None (There is no unacceptable risk.)
⹅⹅Main Unit
Operation 2018-02-21 30
Symbols * Some symbols may not be used.
31 Operation 2018-10-21
Electromagnetic Disturbances (EMD)
The Root ZX mini (hereafter “this device”) conforms to IEC 60601-1-2:2014 Ed. 4.0, the relevant
international standard for electromagnetic disturbances (EMD).
The following is the “Guidance and Manufacturer’s Declaration” which is required by IEC 60601-1-2:2014
Ed. 4.0, the relevant international standard for electromagnetic disturbances.
This is a Group 1, Class B product according to EN 55011 (CISPR 11).
This means that this device does not generate and/or use internationally radio-frequency energy,
in the form of electromagnetic radiation, inductive and/or capacitive coupling, for the treatment of
material or inspection/analysis purpose and that it is suitable for use in domestic establishments
and in establishments directly connected to a low voltage power supply network which supplies
buildings use for domestic purposes.
*1: The test is not applicable since the EUT does not have AC ports.
Operation 2018-10-21 32
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
This device is intended for use in the electromagnetic environment specified below.
The customer or the user of this device should assure that it is used in such an environment.
Electromagnetic
Immunity Test IEC 60601 Test Level Compliance Level
Environment – Guidance
AC/DC power
AC/DC power
±0.5 kV, ±1 kV line(s) to
±0.5 kV, ±1 kV line(s) to line(s) Mains power quality
Surge*1 line(s)
±0.5 kV, ±1 kV, ±2 kV line(s) to should be that of a
±0.5 kV, ±1 kV, ±2 kV line(s)
IEC 61000-4-5 earth typical commercial or
to earth
Signal input/output hospital environment.
Signal input/output
±2 kV line(s) to earth
±2 kV line(s) to earth
Mains power quality
should be that of a
dips dips typical commercial or
0% UT : 0.5 cycle (at 0, 45, 0% UT : 0.5 cycle (at 0, 45, 90, hospital environment.
Voltage dips, short 90, 135, 180, 225, 270, 315°) 135, 180, 225, 270, 315°) If user of this device
interruptions and 0% UT : 1 cycle (at 0°) 0% UT : 1 cycle (at 0°) requires continued
voltage variations on 70% UT : 25/30 cycles (at 0°) 70% UT : 25/30 cycles (at 0°) operation during power
power supply lines*1 25 (50 Hz)/30 (60 Hz) 25 (50 Hz)/30 (60 Hz) mains interruptions, it
IEC 61000-4-11 short interruptions short interruptions is recommended that
0% UT : 250/300 cycles 0% UT : 250/300 cycles this device be powered
250 (50 Hz)/300 (60 Hz) 250 (50 Hz)/300 (60 Hz) from an uninterruptible
power supply or a bat-
tery.
Power frequency mag-
Power frequency netic field should be at
(50/60 Hz) magnetic 30 A/m (r.m.s.) 30 A/m (r.m.s.) levels characteristic of
field 50 Hz or 60 Hz 50 Hz or 60 Hz a typical location in a
IEC 61000-4-8 typical commercial or
hospital environment.
NOTE 1: UT is the a.c. mains voltage prior to application of the test level.
NOTE 2: r.m.s.: root mean square
*1: The test is not applicable since the EUT does not have AC ports.
33 Operation 2018-10-21
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
This device is intended for use in the electromagnetic environment specified below.
The customer or the user of this device should assure that it is used in such an environment.
Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment – Guidance
Conducted RF 3V 3V Portable and mobile RF communications
IEC 61000-4-6 ISM(c) / amateur radio ISM(c) / amateur radio equipment should be used no closer to any
frequency band: 6 V frequency band: 6 V part of this device, including cables, than
150 kHz to 80 MHz 150 kHz to 80 MHz the recommended separation distance
calculated from the equation applicable to
Radiated RF 10 V/m 10 V/m the frequency of the transmitter.
IEC 61000-4-3 80 MHz to 2.7 GHz 80 MHz to 2.7 GHz Recommended separation distances
27 V/m 27 V/m d = 1.2 150 kHz to 80 MHz
385 MHz 385 MHz d = 0.4 80 MHz to 800 MHz
28 V/m 28 V/m d = 0.7 800MHz to 2.7 GHz
450 MHz 450 MHz
d= Portable wireless RF commu-
9 V/m 9 V/m nication equipment
710, 745, 780 MHz 710, 745, 780 MHz Where P is the maximum output power rat-
ing of the transmitter in watts (W) accord-
28 V/m 28 V/m ing to the transmitter manufacturer, E is the
810, 870, 930, MHz 810, 870, 930, MHz compliance level in V/m and d is the recom-
mended separation distance in meters (m).
28 V/m 28 V/m
Field strengths from field RF transmitters,
1720, 1845, 1970 MHz 1720, 1845, 1970 MHz
as determined by an electromagnetic site
survey(a), should be less than the compli-
28 V/m 28 V/m
ance level in each frequency range(b).
2450 MHz 2450 MHz
Interference may occur in the vicinity of
9 V/m 9 V/m equipment marked with the following sym-
5240, 5500, 5785 MHz 5240, 5500, 5785 MHz bol:
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 absorp-
tion and reflection from structures, objects and people.
(a) Field strengths from fixed transmitters, such as base stations for ratio (cellular/cordless) telephones and
land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicated
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
this device is used exceeds the applicable RF compliance level above, this device should be observed to
verify normal operation. If abnormal performance is observed, additional measures may be necessary,
such as reorienting of relocating this device.
(b) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
(c) The ISM (Industrial, Scientific and Medical) bands between 0.15 MHz and 80 MHz are 6.765 MHz to 6.795
MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz.
The amateur radio bands between 0.15 MHz and 80 MHz are 1.8 MHz to 2.0 MHz, 3.5 MHz to 4.0 MHz, 5.3
MHz to 5.4 MHz, 7 MHz to 7.3 MHz, 10.1 MHz to 10.15 MHz, 14 MHz to 14.2 MHz, 18.07 MHz to 18.17
MHz, 21.0 MHz to 21.4 MHz, 24.89 MHz to 24.99 MHz, 28.0 MHz to 29.7 MHz and 50.0 MHz to 54.0 MHz.
Essential Performance
None
Cable List
No. Interface(s): Max. Cable Length, Shielding Cable Classification
1. Probe Cord 1.7 m, Un-shielded Signal Line (Patient-Coupled Cable)
Operation 2018-10-21 34
Diagnostic and Imaging Equipment
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Endodontic System
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