NSK OM-E0859E Manual de usuario
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1 User and Intended Purpose
User: Qualified professional (surgeon with knowledge and skills required for operating this
product).
Intended purpose: This product is a link device which enables the Surgic Pro2 foot control
to operate the VarioSurg 3. This product is mounted on VarioSurg 3 and communicates via
Bluetooth®with Surgic Pro2 to enable switching and operation of the two systems (Surgic
Pro2 Surgical Micromotor System and VarioSurg 3 Ultrasonic Bone Surgery System) with
one foot control.
Contents
1. User and Intended Purpose ...........................................1
2. Precautions for Handling and Operation...................................2
3. Package Contents ..................................................4
4. Preparation for Use .................................................4
4–1 Installation of the Link Module......................................4
4–2 Pairing ......................................................5
5. Operation Procedure ................................................6
5–1 VarioSurg 3 link operation.........................................6
5–2 Foot control operation............................................7
5–3 Switching link .................................................8
6. Post-use Maintenance...............................................8
6–1 Preparation for maintenance .......................................8
6–2 Cleaning and disinfection .........................................8
6–3 Periodical maintenance checks .....................................9
7. Spare Parts List ...................................................9
8. Specifications....................................................10
8–1 Specifications ................................................10
8–2 Operation princple .............................................10
8–3 Warranty ....................................................10
8–4 Disposing product .............................................10
8–5 Symbol .....................................................11
9. EMC Information (Electromagnetic Compatibility Information) ...................12
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2 Precautions for Handling and Operation
Read these safety cautions thoroughly before use and operate the product properly.
These indicators are to allow you to use the product safely, prevent danger and harm to
you and others. These are classified by degree of danger, damage and seriousness. All
indicators concern safety, be sure to follow them.
Class Degree of Risk
WARNING Hazard that could result in serious injury or damage to the device if the
safety instructions are not correctly followed.
CAUTION Hazard that could result in light or moderate injury or damage to the
device if the safety instructions are not correctly followed.
NOTICE General product specification information highlighted to avoid product
malfunction and performance reduction.
WARNING
• TO PREVENT ELECTRIC SHOCK, do not unplug the link cable with wet hands.
• TO PREVENT ELECTRIC SHOCK, be sure to prevent water or antiseptic from getting on
the Link Module. If it gets on the Link Module, wipe it off immediately.
• TO PREVENT ELECTRIC SHOCK, use the link cable supplied with the Link Module.
• The system may malfunction when used in the presence of an electromagnetic
interference wave. Do not install the system in the vicinity of the device which emits
electromagnetic waves. Turn off the main power switch of the VarioSurg 3 if a high
frequency oscillation device such as an electrode knife is in the vicinity and used.
WARNING
• Do not operate close to patients with cardiac pacemakers as there is a danger that it
may affect the pacemaker.
• Do not use in rooms with a risk of explosion or near flammable substances. Also, do
not use on or near patients under flammable anesthesia (Nitrous Oxide).
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CAUTION
• The Link Module needs special precautions regarding EMC (electromagnetic
compatibility) and needs to be installed and put into service in accordance with
the EMC information. (See “9 EMC Information (Electromagnetic Compatibility
Information)”)
• Portable and mobile RF (Radio Frequency) communications equipment can affect this
product. Do not use RF equipment outskirts for the product.
• The use of components other than those specified by the manufacturer may reduce
the performance of the Link Module relative to EMC.
• The Link Module should not be used adjacent to, or stacked with, other equipment.
If the Link Module must be used adjacent to or stacked with other equipment, make
sure that the device operates without malfunction.
• When operating this system, always consider the safety of the patient.
• Do not attempt to disassemble the product nor tamper with the mechanism. Doing so
may result in an injury, electric shock or fire.
• Before each use, inspect device operation to make sure there are no abnormalities.
• Especially when using again after a long period of disuse, be sure to inspect
before use. If you detect abnormal heat or the like before or during use, stop using
immediately and request repair.
• Do not drop, hit, or subject to excessive shock. Doing so could cause malfunctions.
• Make sure each component is securely connected before turning on the power of the
VarioSurg 3.
• If there is dirt on the Link Module, remove the link cable and wipe it off thoroughly
with a moist cloth. Turn off the VarioSurg 3 before cleaning.
CAUTION
• The Link Module cannot be sterilized by any method.
• Do not wipe or clean with highly acidic water. Do not immerse in any solutions.
• Do not use this product for purposes other than to link the Surgic Pro2 and VarioSurg 3.
• Read this operation manual and the operation manuals of VarioSurg 3 and Surgic
Pro2 carefully before connecting for use. Proper care & maintenance is important
for the long term durability of both products. Keep this operation manual within easy
reach of users for future reference.
NOTICE
• Turn off the main power switch of the Surgic Pro2 and the VarioSurg 3 control units
after each use.
• No special training is required to operate this device.
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3 Package Contents
Connector socket
Button
Foot control plug
Connector
Lock nut
No. Part name Quantity
Link box 1
Link cable 1
4 Preparation for Use
4–1 Installation of the Link Module
1 Insert the connector of the link cable
into the connector socket of the link
box.
2 Insert the foot control plug of the
link cable into the foot control cord
connector socket of the VarioSurg 3 and
tighten the lock nut firmly.
CAUTION
• Install or remove the Link Module only when the power of the VarioSurg 3 is OFF.
• Avoid unnecessary removal of the link cable. Poor contact of the connector can cause
malfunction.
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4–2 Pairing
To use the Link Module, you must first pair the Link Module and the Surgic Pro2.
Surgic Pro2 operation
3,5 2 4
1 Turn on the main power switch of Surgic
Pro2.
2 Press and hold the Setting key for 2
seconds or more to display “BLE SET”.
3 Press the Enter key.
4 Press the TORQUE key and select “LK”.
5 Press the Enter key.
Link Module operation
6 Turn on the VarioSurg 3. The LED of the
Link Module blinks white.
7 Press and hold the button on the Link
Module.
8 When the LED turns blue, release the
button.
9 Pairing is successful when the Surgic
Pro2 beeps and displays “OK”. After
pairing, the Surgic Pro2 is automatically
connected to the Link Module. During
connection, the LED of the Link Module
blinks green and the Bluetooth mark
blinks on the left of the “VARIOSURG”
icon on the Surgic Pro2 display.
10 Press the Cancel key of the Surgic Pro2
twice to end setting mode.
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CAUTION
• If any abnormalities are found with the Surgic Pro2 and the VarioSurg 3, refer to the
respective operation manuals.
• If the button is not released after the LED turns blue, the LED blinks white and pairing
stops. To pair, release the button, and after the LED turns white, proceed from step 7.
NOTICE
• Pairing operation is required only for the first time. After that, the Link Module is
automatically connected when the Surgic Pro2 and the VarioSurg 3 are turned on. To
unpair the Surgic Pro2 and the Link Module, the Surgic Pro2 needs to be operated.
Refer to the Surgic Pro2 operation manual for details.
5 Operation Procedure
Turn on the paired Surgic Pro2 and the VarioSurg 3 connected to the Link Module.
5–1 VarioSurg 3 link operation
1 Make sure that the LED of the Link
Module blinks green and the Bluetooth
mark is on the left of VARIOSURG icon
on the Surgic Pro2 display.
2 Press and hold the LINK key of the
Surgic Pro2 for more than 2 seconds.
The Surgic Pro2 displays “LINK” and the
VarioSurg 3 can be operated with the
foot control.
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CAUTION
• If external interference is received during connection, the connection can be
cancelled.
• The VarioSurg 3 cannot be operated except when the Surgic Pro2 displays "LINK".
Check the display of the control unit before treatment.
• Do not turn off one of the control units or unplug the power cord during operating the
Link Module. Do not remove the link cable.
5–2 Foot control operation
Left button
Select coolant solution flow level from 5 levels. If the button is depressed when the flow is
set to level 5, it returns to level 1. (Level 0 cannot be selected for the Coolant Flow.)
Press and hold the button for more than 2 seconds: Switching to the linked device. It
switches operation to the Surgic Pro2 or the device linked to the Surgic Pro2.
Center button
Select a program number.
Press and hold the button for more than 2 seconds: Return to the previous program.
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Right button
Select a Burst Output Level
Speed control pedal
Vibrate the tip at the set power while the pedal is depressed.
CAUTION
• Changing the settings of the foot control buttons of Surgic Pro2 is enabled only when
operating Surgic Pro2.
NOTICE
• When the Surgic Pro2 displays “LINK”, key operations other than the LINK key and
Cancel key are disabled.
5–3 Switching link
Press and hold the LINK key of the Surgic Pro2 for more than 2 seconds to switch the link
connection.
Press and hold the Cancel key of Surgic Pro2 for more than 2 seconds to return to the
operation of Surgic Pro2.
6 Post-use Maintenance
6–1 Preparation for maintenance
1 Wear eye protection, a mask, and gloves
to prevent infection.
2 Turn off the power switch of the
VarioSurg 3 control unit.
6–2 Cleaning and disinfection
1 Wipe the surface of the products with
a cloth moistened with ethanol for
disinfection.
2 Store the products in a place where they
can be kept clean and dry until used
next time.
CAUTION
• Do not clean, immerse, or wipe with electrolyzed-oxidizing water (strong acidic
water, super acidic water), strong acidic and strong alkaline liquid solution, solvent
containing chlorine, benzene or thinner.
• Follow any additional local directives, standards, and guidelines for cleaning,
disinfection and sterilization.
• For maintenance of the Surgic Pro2 and the VarioSurg 3, refer to the operation
manual for each product.
• Use ethanol for disinfection that complies with the regulations of each country.
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6–3 Periodical maintenance checks
Every 3 months perform periodical maintenance checks, referring to the check sheet below.
If any abnormalities are found, contact an authorized NSK dealer.
Points to Check Details
Link Module Make sure that the Link Module is securely connected to the
VarioSurg 3.
Make sure Bluetooth communication is executed normally.
Make sure the LED illuminates normally.
7 Spare Parts List
Model
Link Box Z1402010
Link Cable Z1402051
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