NSK Surgic XT Operation Manual

SURGERY SYSTEM
OPERATION MANUAL
OM-E0262E
0197
• Keep out from explosive substances and flammable materials. Do not use for patients anesthetized with nitrous oxide gas especially.
• Surgic XT is intended for use in dental, oral surgical, and surgical procedures. Do not use in operating rooms due to potential flammable gas mixtures present in such environment.
• Patient safety is a priority.
• Read this Operation Manual before use, and fully understand the functions of each part for starting use.
• Inspect the operating status of the equipment before use, and use only after confirming that no abnormalities exist.
• Test run the product to ensure its correct operation prior to using it.
• If the product should ever malfunction (excessive vibration, noise, heat, etc) please turn it off immediately and return it to your Authorized Dealer for inspection.
• When the product is very frequently used please consider the maintenance of a small stock of replaceable parts.
• Use the equipment only after preparing spares for consumable parts. In particular, the preliminary head SGM easily fails as a result of intrusion of blood or saline solution, therefore, be sure to prepare spare parts.
• Use an electrical outlet that is grounded.
• To avoid possible injury or product damage, ensure that the Micromotor has completely stopped before changing burs.
• Severe shock – Eg. Dropping the product – may cause damage.
• Do not bend the Irrigation Tube while the water pump is operating. It could cause tube breakage.
• Never attempt to disassemble the Control Unit, the Foot Control or the Micromotor.
Handpiece Attachments should be cleaned, lubricated and sterilized immediately after use.
• Do not lubricate the Micromotor. Oil could generate excessive heat and cause damage.
• The Control Unit and the Foot Pedal Controller cannot be sterilized by any method.
• The Control Unit may be cleaned with a moist cloth. Disconnect the power supply before cleaning.
• Do not clean the Control Unit with any solvent solutions.
• Do not disconnect the motor cord from the motor.
• Make sure that the cover is not fitted during calibration.
• Be sure to dispose of the irrigation tube as medical waste after use.
• The system functions normally in the environment where the temperature is at 0-40ºC (32­104ºF), humidity at 10-85% RH, atmospheric pressure at 500- 1060hPa, and no moisture condensation in the Control Unit. Use at outside of these limits may cause malfunction.
S Classification of equipment
• Type of protection against electric shock : – Class l equipment
• Degree of protection against electric shock : – Type BF applied part
• Method of sterilization or disinfection recommended by the manufacture : – See 8. Sterilization
• Degree of protection against ingress of water as detailed in the current edition of IEC 529 : – Foot Control : IPX8 (Protected against the effects of continuous immersion in water)
• Degree of safety of application in the presence of a flammable anesthetic mixture with air or with oxygen or nitrousoxide : – EQUIPMENT not suitable for use in the presence of a flammable anesthetic mixture with
air or with oxygen or nitrousoxide
• Mode of operation : – Continuous operation
IMPORTANT
For correct operation please read this manual before use.
CONTENTS
1. Safety precautions prior to use
2. Package contents
3. Control unit with an irrigation pump
4. Foot control
5. Installation
6. Operation
7. Care and maintenance
8. Sterilization
9. Optional accessories
10. Specifications
11. Disposing product
SAFETY CAUTIONS
Read these safety cautions thoroughly before use and operate the product properly. These indicators are to allow you to use the product safely and 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.
Indicators of Hazardous Conditions
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Safety precautions prior to use
1
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Classification
WARNING
CAUTION
NOTICE
Degree of Danger or Danger and Seriousness
Explains an instruction where personal injury or physical damage may occur.
Explains an instruction where minor to medium injury or physical damage may occur.
Explains an instruction that should be observed for safety reasons.
WARNING
CAUTION
• Turn off the Power Switch after each use.
• For service requirements and spare parts please contact your dealer.
• The use of NSK genuine pre-sterilized, disposable Irrigation Tube Kit is recommended.
• Store the system in the place where the temperature is at -10-60ºC (14-140ºF), humidity at 10-85%RH, atmospheric pressure at 500-1060 hPa, and the system is not subject to air with dust, sulfur, or salinity.
NOTICE
Thank you for purchasing the NSK Surgic XT, surgical unit.
The EU directive 93/42/EEC was applied in the design and production of this medical device.
Description of Operation
S Keys on the Unit
a Program key
This key is used to select any one of 10 available programs. Press [+] to ascend program numbers and [-] to descend the numbers. By pressing either [+] or [-] the numbers rotate continuously through all available programs.
s Speed key
This key is used to set the micromotor speed. Press [+] to increase speed by one step, and [-] to decrease speed by one step. When [+] is pressed and the speed setting reaches maximum or [-] is pressed and the speed setting reaches minimum, an audible intermittent beep sounds, and the speed cannot be changed any further.
d Torque key
This key is used to set the torque. Press [+] to increase torque by one step and [-] to decrease torque by one step. When [+] is pressed and the torque setting reaches maximum, or [-] is pressed and the torque setting reaches minimum, an audible intermittent beep sounds, and the torque cannot be changed any further. The range of torque setting steps vary according to the gear ratio selected to match the handpiece attachment in use.
f System key
This key is used to calibrate the handpiece attachment before use. To activate the automatic calibration mode, connect the handpiece attachment to the micromotor and press this key. The micromotor will automatically operate for a few moments and, when it automatically stops, the handpiece attachment will be calibrated to the micromotor.
g Gear Ratio key
This key is to select match ratio of the handpiece attachment, before use, to the unit. Press this key until the LCD display exhibits the correct gear ratio of the handpiece attachment.
h Coolant Flow key
This key is used to select the coolant solution flow volume. 5 flow volume rates are available for selection, plus the flow can be turned off.
j Forward/Reverse key
This key is used to change the rotational direction of the micromotor. Press this key once to change the rotational direction.
k Memory key
This key is used to memorize the program parameters set by the operator. Press this key for approx. 1 second to memorizes parameters. An audible beep confirms that new program parameters have been memorized.
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Gear Ratio key
Coolant Flow key
Forward/Reverse key
System key
Memory key
Speed key
Program key
Torque key
Coolant Solution Hanger Post
AC Electrical Cord Connection Jack
Fuse Holder
Main Power Switch
Micromotor Cord Jack
Foot Control Cord Jack
Package contents
Irrigation Pump
2
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!2 t i r o !4 !5 !6 !7
q
w
e
r
t
y
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i
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Quantity
1
1
1
1
1
1
5
1
1
Description
Control Unit with Irrigation Pump
Foot Control
AC Electrical Cord
Autoclavable Micromotor with Cord
Reduction Handpiece Attachment (Opt)
Micromotor Cradle
Irrigation Tube
Internal Spray Nozzle
Irrigation Tube Clamp
Item
No.
!0
!1
!2
!3
!4
!5
!6
!7
Quantity
7
1
1
2
1
1
1
1
Description
Tube Holder
Coolant Solution Hanger Post
Wrench for Handpiece Attachment
Spare Fuse
Y-connector
Nozzle Cleaning Fine Wire
Autoclave Plug for Motor
Spray Lubricant Nozzle
Item
No.
Control Unit with an Irrigation Pump
3
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