Nakanishi NSK iProphy Air Guide Rapide

Air Motor Handpiece for Disposable Prophy Angle
1. User and Indications for Use
User: Qualified Professionals
Indications for Use: The Nakanishi iProphy Air is a prophylaxis handpiece for use with
disposable prophy angles in hygiene operatory to perform cleaning and polishing procedures
on teeth.
2. Precautions for handling and operation
Please read these precautions carefully and use only as intended or instructed.
Safety instructions are intended to avoid potential hazards that could result in personal
injury or damage to the device. Safety instructions are classified as follows in accordance
with the seriousness of the risk.
WARNING Degree of Risk
A hazard that could result in serious injury or damage to the
WARNING
device if the safety instructions are not followed.
A hazard that could result in light or moderate injury or damage
CAUTION
to the device if the safety instructions are not followed.
General product specification information highlighted to avoid
N O T I C E
product malfunction and performance reduction.
WARNING
· Clean and lubricate the handpiece immediately (within 1 hour) after each treatment to
remove residue. Failure to properly maintain the handpiece may cause infection, product
failure, overheating leading to burn injuries. (Refer to "8. Post-use Maintenance")
CAUTION
· Read this Operation Manual before use to fully understand the product functions.
· When operating the handpiece always consider the safety of the patient.
· Users are responsible for the operational control, maintenance and continual inspection of
this product.
· Do not attempt to disassemble the handpiece or tamper with the mechanism except as
recommend by NSK in this Operation Manual.
· Do not allow any impact on to the handpiece. Do not drop the handpiece.
· Should the handpiece function abnormally cease operation immediately and contact your
Authorized NSK Dealer.
· Do not use high acid water or sterilizing solutions to wipe, immerse or clean the handpiece.
· The products are delivered in a non-sterile condition and must be autoclaved prior to use.
· Perform function and maintenance checks periodically.
· If the product is not used for a long period check it is functioning correctly before using on a
patient.
· To avoid clinical downtime it is recommended that a spare be kept on hand in case of a
breakdown during surgery.
· US Federal law restricts the sale of this device to or by order of a licensed physician.
3. Accessory List
No. Part Name
1 E-Type Spray Nozzle
4. Setting the Air Supply Pressure
Measure the supply pressure at the handpiece/hose
connection point and set the pressure to
0.20 - 0.25MPa as specified on the specification
table. (Fig. 1)
Handpiece
WARNING
Do not exceed 0.25MPa.
CAUTION
Do not use air contaminated by dust, moisture or oil.
5. Connection & Disconnection of the Handpiece
5-1 Connection
Handpiece
1) Insert the handpiece correctly into the hose
connector and tighten the hose nut. (Fig. 2)
2) Make sure the handpiece is connected firmly
to the Hose.
5-2 Disconnection
Loosen the Hose Nut and and remove from the Hose. (Fig. 2)
6. Mounting and Removal of the Disposable Prophy Angle
CAUTION
Do not attempt to mount or remove the Disposable Prophy Angle until the motor has
completely stopped.
NOTICE
The disposable Prophy Angle's positioning mark depends on the manufacturer. It may
be different from the position of Fig. 3.
6-1 Mounting
To mount the handpiece and the Disposable Prophy Angle, align the positioning marks of
the handpiece and the Disposable Prophy Angle and insert firmly.
CAUTION
After the Disposable Prophy Angle is mounted
check that the positioning mark of Disposable
iProphy Air
Prophy Angle and handpiece are properly
aligned.
6-2 Removal
To disconnect hold the Disposable Prophy Angle and the handpiece and pull out straight.
OM-M0129E 001
7. Check before Treatment
Follow the check below before use. If any abnormalities are found stop using the handpiece
immediately and contact your NSK dealer.
1) Connect the Disposable Prophy Angle. (Do not exceed maximum rotation speed for any
item.)
2) Check that there is no abnormal rotation, vibration, noise or overheating.
3) If there are no immediate apparent abnormalities continue to rotate the handpiece for
about 1 minute. Then check if there is no abnormal heating on the outer surface.
4) Operate it if there are no abnormalities above.
8. Post-use Maintenance
8-1 Preparation
1) Remove the Disposable Prophy Angle from
the handpiece.
2) Wipe the exterior of the handpiece clean
using a cloth moistened with disinfectant.
3) Remove the handpiece tip (iPA-HP) from the motor (iPA). (Fig. 4)
4) Remove the motor (iPA) from the hose.
8-2 Cleaning
1) Clean the external surfaces of the handpiece (iPA-HP / iPA) with a soft bristled brush
under running water.
2) Use a dry cloth to completely remove any exterior moisture.
3) Wipe the exterior of the handpiece (iPA-HP / iPA) clean using a cloth moistened with
disinfectant.
CAUTION
To clean the handpiece never use any solvent such as benzine or thinner.
8-3 Lubrication
Apply NSK PANA SPRAY Plus after every use and/or before autoclaving.
1) Mount the tip nozzle into the spray can port. (Fig. 5)
2) Insert the tip nozzle into the Drive Air Port of the motor (iPA). Hold the motor and spray
for approximately 2-3 seconds. Apply lubricant until it comes out from the exhaust air
port (see Fig. 6) for at least 2 seconds.
3) Attach the Spray Nozzle into the Spray Port nozzle on the can. (Fig. 7)
4) Insert the Spray Nozzle into the rear of the hanpeace tip (iPA-HP). Hold the handpiece
tip and spray 2-3 times for approximately 2-3 seconds each time. Apply lubricant until
it expels from the handpiece tip head for at least 2 seconds. (Fig. 7)
Tip Nozzle
iPA
Quantity
1
Hose
CAUTION
· Firmly hold the handpiece to prevent it slipping when spray pressure is applied.
Drive Air Pressure
Fig. 1 · Hold the spray can upright.
8-4 Sterilization
Sterilize the product by autoclave sterilization.
1) Insert the handpiece into an FDA-approved sterilization pouch that conforms to ISO
11607-1, and seal the pouch.
2) Perform steam sterilization with the following conditions.
Type
Tighten
Temperature
Exposure Time
Drying Time
Hose Nut
Loosen
CAUTION
Fig. 2
· Use an FDA-approved steam sterilizer to perform sterilization.
· Follow local rules, regulations, and guidelines regarding the reprocessing of devices.
· Do not touch the product immediately after steam sterilization as it will be very hot and
must remain in a sterile condition.
· Do not perform steam sterilization on the product with other instruments even when it
is in a pouch. This is to prevent possible discoloration and damage to the product from
chemical residue on other instruments.
· Clean and lubricate the handpiece prior to sterilization. If blood remains on the internal
surface it can become clotted and cause product failure.
· Do not heat or cool the product too quickly. Rapid change in temperature could cause
damage to the product.
· Be sure to use sterilizers that can perform sterilization up to 135°C. In some sterilizers,
the chamber temperature may exceed 135°C. Do not use these sterilizers as failure of
the handpiece could occur. Contact the sterilizer manufacturer for detailed information
about cycle temperatures.
· Steam sterilization is recommended for the product. The validity of other sterilization
methods (such as plasma sterilization or EOG sterilization) is not confirmed.
Positioning Mark Positioning Mark
Disposable Prophy Angle Handpiece
Fig. 3
iPA-HP iPA
Fig. 4
Midwest 4-hole
Exhaust Drive Air
Air Port Port
PANA SPRAY Plus
Fig. 5 Fig. 6
E-Type Spray Nozzle
iPA-HP
Fig. 7
Gravity Displacement Pre-Vacuum (Dynamic Air Removal)
132°C (270°F) 132°C (270°F)
15min 4min
30min 30min
8-5 Storage
Store the product in a dry, clean location.
CAUTION
· After the sterization and drying cycles are complete, remove the handpiece
immediately from the sterilizer to store it.
· Store the product in a well ventilated place out of direct sunlight and within the range of
temperature, humidity and pressure specified in "10. Specifications".
· Sterilization is not guaranteed after the sterilization retention period specified by the
manufacturer and seller of the sterilization pouch has elapsed.
If the sterilization retention period has elapsed, perform sterilization again with a new
sterilization pouch.
9. Periodic Maintenance Checks
Perform periodic maintenance checks every three months by referring to the check sheet
below. If any abnormalities are found contact your Authorized NSK Dealer.
Points to check
Rotate the handpiece and check for abnormalities such as
Rotation
abnormal rotation, vibration, noise, or overheating.
10. Specifications
Model iProphy Air
Hose Connection Type ISO9168 Type 2
Max Rotation Speed 2,000 - 3,000min
Drive Air Pressure 0.20 - 0.25MPa (2.0 - 2.5kgf/cm
Max Air Consumption <66NL/min (0.25MPa)
Temperature 10 - 35 °C
Use
Humidity 30 - 75%
Environment
Atmospheric Pressure 700 - 1,060hPa
Transportation
Temperature -10 - 50 °C
and Store Humidity 10 - 85%
Environment Atmospheric Pressure
500 - 1,060hPa
iPA-HP iPA iProphy Air Color Ring
11. Symbols
This product is Autoclavable up to Max.135°C.
Manufacturer
Caution: US Federal law restricts the sale of this device to or by
order of a licensed physician.
12. Warranty
NSK products are warranted against manufacturing errors and defects in materials. NSK
reserves the right to analyze and determine the cause of any problem. Warranty is voided
should the handpiece be used incorrectly or for anything other than the intended purpose,
has been tampered with by unqualified personnel or has had non NSK parts installed.
Replacement parts are available for seven years after discontinuation of the model.
13. Option Parts List
Model Order Code
MG-4H Multi Gauge Z109400
14. Spare Parts List
Model Order Code
iPA M1020006
iPA-HP M1020005
iProphy Air Color Ring Set Y1002594
E-Type Spray Nozzle Z019090
15. Disposing product
To avoid health risks and environmental contamination from the disposal of medical
equipment a licensed physician must verify equipment is sterile prior to disposal. Seek the
assistance of specialist firms who are licensed to dispose of specially controlled industrial
wastes to dispose the product for you.
Details
(0.25MPa)
-1
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2020.03.11 05 ヤ