Pac-Dent PROMATE CL User manual

Instruction Manual
(Please carefully read instruction manual before first use.)
670 Endeavor Circle, Brea, CA 92821
[phone]
[email protected]
www.pac-dent.com
#08IFUPMCL100 Rev.050421

Read this manual carefully before operating.
Keep it in a safe place for further consultation.
Contents
1. Product Introduction
2. Installation
3. Function & Operation of Product
4. Operation Instruction
5. Troubleshooting
6. Cleaning, Disinfection, & Sterilization
7. Storage, Maintenance, & Transportation
8. Environmental Protection
9. After-Sales Service
10. Symbol Instruction
11. Statement
12. EMC-Declaration of Conformity
13. FCC Statement
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IEC 60601-1
EN ISO 13485
This equipment has been designed and developed in
compliance with Electric Safety standard IEC 60601-1
enforced. It was designed and manufactured in
accordance with an EN ISO 13485-certify quality
assurance system.

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1. Product Introduction
1.1 Preface
Thanks for purchasing the Pac-Dent ProMate™ CL Cordless Hygiene Handpiece. The ProMate™
CL medical device that you are about to install and use in your practice is a medical device
designed for professional use. It comprises the chosen tool with which you will provide treatment
within the context of your work.
To ensure optimum safety for yourself and your patients, comfort in your daily practice and to
benefit fully from the technology of your medical device, please read the documentation provided
carefully.
If you have received this medical device by mistake, please contact the supplier to arrange for it to
be collected.
1.2 Product description
The ProMate™ CL Cordless Hygiene Handpiece has been designed to provide the clinician with
an ergonomic handpiece that delivers independence from heavy cord-drag, dual-mode speed
control, and operator comfort during prophylaxis procedures. Pac-Dent's cordless prophy
handpiece provides the flexibility of using any preferred disposable prophy angles (DPA) on the
market. The sterilizable outer sheath has been designed to be steam autoclavable in compliance
with the CDC’s sterilization and infection control guidelines. A disposable polyethylene barrier is
available to cover the handpiece.

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•Read all instructions before operating this unit. The manufacturer accepts no liability for any
damage resulting from improper use of this unit and/or for any purpose other than those
covered by these instructions.
•Use only for the intended use. Failure to comply with the operating instructions may result in
serious injury to the patient or operator. Before operating this device, verify that you have
read and understood the operating instructions.
•U.S. Federal law restricts this unit to sale by or on the order of a dentist.
•Do not insert any object into the base or handpiece.
•Do not install near an explosive risk. Systems are not designed to operate in the presence of
anesthetic gases or any other flammable gas.
•Connect the power cord to an appropriate outlet. Use only the supplied power adapter.
•Do not use dry heat sterilization on any of the device’s components.
•Do not perform repairs or make changes to the device without prior consent from Pac-Dent.
•In the event of an abnormality, contact Pac-Dent. Do not call any other repair service, which
may cause your device to be dangerous to you and your patients.

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1.3 Operator population
Operation of this medical device is limited only to certified, capable, and qualified dental
professionals in their regular place of business. The operator must master and comply with the
rules of dental practice in accordance with science and principles of medical hygiene, such as the
cleaning, disinfection, and sterilization of medical devices.
This medical device may be used regardless of the characteristics of the (adult) operator, such as
weight, age, height, sex, and nationality. The operator should wear gloves. The operator must not
be the patient.
Operators should not have:
•Vision problems, unless wearing a form of vision correction.
•A disability of the upper limbs (gripping a rotary tool).
•Hearing problems (use of audible indicators, depending on the device).
•Memory or concentration problems (settings, sequences, or care protocols, etc.).
Special operator training:
•No special training other than basic professional training is required to operate this medical
device.
1.4 Patient population
This medical device is intended for use with the following patient population: children, teenagers,
adults, and senior citizens.

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This medical device may be used regardless of the characteristics of the patient, such as weight
(except for children), age, height, sex, and nationality. Operation of this medical device is
prohibited in the following patient population: implanted heart pacemaker patients (or other
electrical equipment), patients who had been cautioned against the use of small electrical
appliances (such as electric shavers, hair dryers, etc.), infants, pregnant or lactating women,
patients with medical complications, allergic patients, patients with a clinical site not suited for
the treatment. The patient should be calm, relaxed, immobile, and ideally lying down in a dental
chair.
1.5 Body parts or tissue types treated
Treatment should be limited only to the patient’s buccal cavity.
1.6 Principal of operation of the medical device
An electric signal issued by the medical device is supplied to the micro-motor. The micro-motor
is electronically connected to the medical device by means of an electronic signal.

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•The device conforms to applicable electromagnetic compatibility standards. Operators must
ensure that no electromagnetic interference causes an increased risk (presence of radio-
frequency emissions, electronic devices, etc.).
•Interference may occur when used on patients wearing a pacemaker. This system emits
electromagnetic fields, which present potential risks. Implantable devices, such as
pacemakers and ICDs (implantable cardioverter defibrillators), may malfunction.
•Before using this product, ask patients and operators whether they are wearing an implanted
device. Explain the reason for your question.
•Determine the risk/benefit ratio and contact your patient’s cardiologist or applicable specialist
before carrying out the treatment.
•Keep this product away from implanted devices.
•Take necessary emergency measures and immediate action if the patient becomes ill.
1.7 Interactions
1.8 Features
• Wireless handpiece
• Accurate and stable speed control. It enables more stable polishing compared with
traditional pneumatic low-speed handpieces.
• One-button speed control
• Wireless foot control (optional).

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1.9 Model and specification
ProMate™ CL Cordless Hygiene Handpiece
Please refer to the packing list for device configurations. Section 1.6 Principal of operation of the
medical device.
1.10 Components
•1 Handpiece (motor)
The handpiece houses the motor, gear box, power supply (lithium-ion battery) and three indicator
lights, and is not sterilizable. REF#: PMCL-101
•3 Autoclavable Outer Sheaths
The outer sheath is a sterilizable protective cover that acts as a barrier to the internal handpiece
component (motor component). It also houses the bearings and acts as an interface between a
DPA and the handpiece. The autoclavable outer sheath features an on-board user control button
(ON/OFF/Speed Mode) for power and rotation speed control. REF#: PMCL-102
•1 Wireless Foot Pedal
The wireless Bluetooth connection foot pedal allows a duo-mode speed control by pressing the
pedal progressively to speed up rotations, or regressively to slow down rotations.
REF#: PMCL-103

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•1 Inducting Charging Base
Induction charge base allows the handpiece to be placed into the charger without hard
connections. REF#: PMCL-104
•1 AC Adapter. REF#: PMCL-105
•1 Pack of 100 Disposable Plastic Barriers (placed over the handpiece and under the outer
sheath for infection prevention). REF#: PMCL-106
Charging Indicator
Disposable
Prophy Angles
Centralized
Control Button
Outer Sheath
Motor Component
Foot Control
Power Adapter
Charging Station
Charging Indicator

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1.11 Scope of application
It is mainly used for teeth cleaning and polishing. The device must be operated in hospital and
clinic settings by the qualified dentists.
1.12 Contraindications
•Doctors with a pacemaker are prohibited from using this device.
•In cases where a patient has been fitted with an implanted heart pacemaker (or other
electrical equipment) and has been cautioned against the use of small electrical appliances
(such as electric shavers, hair dryers, etc.), it is recommended not to use this device.
•Hemophilia patients are prohibited from using this device.
•For patients with heart disease, pregnant women and young children, cautiously use this
device.
•Read this instruction manual carefully before the first operation.
•This device should be operated by professional and qualified dentists in qualified hospital or
clinic.
•Do not directly or indirectly place this device near heat source. Operate and store this device
in a reliable environment.

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•This device requires special precautions regarding electromagnetic compatibility (EMC) and
must be in strict accordance with the EMC information for installation and use. Do not use
this equipment near fluorescent lamps, radio transmitting devices, remote control devices,
handheld and mobile high-frequency communication devices.
•Long term use of equipment may result in overheating of motor handpiece, thus it should be
left to cool for next use. If the motor handpiece is overheated frequently, please contact
Pac-Dent.
•Use the original charging base.
•Do not make any changes to the device. Any changes may violate safety regulations, causing
harm to the patients. The manufacturer will not accept any liability for the modified device.
•Use original power adapter. A different power adapter will result in damage to lithium battery
and control circuit.
•The component, charging base, power adapter, and foot control cannot be autoclaved. Use a
disinfectant of neutral pH value or ethyl alcohol to wipe its surface.
•Before the motor component stops rotating, do not install or remove the outer sheath.
•Before the motor component stops rotating, do not remove the disposable prophy angle.
•Before starting the handpiece, please ensure that the disposable prophy angle was correctly
installed and locked.
•Use a disposable prophy angle fitting the interface of this device.

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•Error in replacing detachable components can lead to unacceptable risks. Replace the
detachable components according to the correct steps in the instructions.
•Wireless charging will generate heat, and the surface temperature of the charging base and
motor handpiece will rise. It is recommended that the time of contacting motor handpiece
and charging base during wireless charging should not exceed 10 seconds.
•The device is not intended to be used in areas where liquids are likely to be present at floor
level, such as emergency rooms.
•Replacement of lithium batteries by inadequately trained personnel or incorrect replacement
could result in a hazard, so please contact local distributors to replace the battery if necessary.
•The adapter plug can be used to disconnect from the network power supply. Do not position
the device to make it difficult to operate the disconnection device when charging.
1.13 Device safety classification
1.13.1 Type of operation mode: Continuous operating device
1.13.2 Type of protection against electric shock: Class II equipment with internal power supply
1.13.3 Degree of protection against electric shock: B type applied part
1.13.4 Degree of protection against harmful ingress of water:

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1.13.5 Degree of safety application in the presence of anesthetic mixture with air, oxygen, or
nitrous oxide: Equipment cannot be used in the presence of a flammable anesthetic mixture with
air, oxygen, or nitrous oxide.
1.13.6 Applied part: Disposable prophy angles.
1.13.7 The contact duration of applied part: 1 to 10 minutes.
1.14 Primary technical specifications
•Lithium battery: 3.6V /750mAh
•Power adapter: (Model: DJ-0500100-A5)
•Input: ~100-240V 50Hz/60Hz 0.5-0.2A
•Output: DC5V/1A
•Speed range: 500-4000rpm
•Wireless charging
•Frequency range: 112-205 KHz
•Maximum RF output power of the product: 9.46dBuA/m@3m
Handpiece IPX3
Foot Control IPX1
Charging Base IPX0
Power Adapter IPX0

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1.15 Environment parameters
•Environment temperature: +5 - +40℃
•Relative humidity: 30-75%
•Atmospheric pressure: 70-106kPa

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2. Installation
2.1 Basic accessories of product
Disposable
Prophy Angles
Power Station
Power Adapter
Foot Control
Outer Sheath
Motor Component
REF# PMCL-103
REF# PMCL-104
REF# PMCL-105
REF# PMCL-101
REF# PMCL-102

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2.2 Instructions for Disposable Barrier
2.2.1 Before installing the disposable barrier, make sure that the motor handpiece is fully
charged prior to operation. If it is of low battery level, please charge the device first.
•Be sure to plug the AC adapter into the appropriate electrical outlet.
•Place the motor component on the inducting charging base connected to the AC adapter.
•Assemble the autoclavable outer sheath on the motor component.
•Charge the handpiece for at least 2 hours.
Before installation, check whether the disposable barrier is intact. If it is damaged, do not
use it.
2.3 Instructions for Outer Sheath
2.3.1 Ensure that the outer sheath has been autoclaved according to the Infection Prevention
Procedure (Section 6.4).
2.3.2 Install the motor component covered with the disposable barrier into the outer sheath.
Before installing the outer sheath, ensure the motor handpiece has stopped.
2.2.2 Insert the motor component into the disposable barrier.

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2.4 Instructions for Disposable Prophy Angle (DPA)
2.4.1 Install the disposable prophy angle (DPA) into the cordless handpiece.
2.4.2 Charge the foot pedal battery connecting it to the AC adapter cable for at least 2
hours.
2.4.3 After fully charged, place the wireless foot pedal in a convenient position.
•A fully charged battery (handpiece and foot pedal) takes at least 2 hours of charge.
•A single full charge without recharging allows the foot pedal to operate continuously up to 72
hours.
•A single full charge without recharging allows the handpiece to perform up to 10 polishes.
•It takes 20 minutes of charge to get one prophylaxis out of a completely discharged battery.
•Please use a disposable prophy angle (DPA) fitting this device.
•Before installing the DPA, please ensure the motor handpiece has stopped.
Important

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3. Function and Operation
3.1 Button definition and settings
3.1.1 Power on
Press the Main Button to turn on the handpiece.
3.1.2 Power off
Hold down the Main button to turn off the handpiece.
3.1.3 Handpiece speed setting
With the handpiece turned on, press the Main button to adjust the speed mode.
Foot Control Mode Controlled by wireless foot control by default
Low Speed Mode 500 rpm
Medium Speed Mode 1500 rpm
High Speed Mode 3000 rpm
Super High Speed Mode 4000 rpm
Centralized
Control Button
Outer Sheath

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3.2 Function and operation of foot control 16
3.2.1 Activate the foot control
Press the pedal for 3 seconds to activate the pedal. When the wireless connection indicator or
power indicator of the pedal is on, it means that the pedal is activated successfully.
3.2.2 Foot control indicator
The foot control has two indicator lights, the wireless connection indicator and the power
indicator. When the pedal is stepped on, if the wireless connection indicator flashes, it indicates
that the pedal is not connected to the handpiece. When the pedal is stepped on, if the wireless
connection indicator light is always on, it indicates that the pedal and the handpiece are
connected. When the power indicator shows yellow, it means the pedal has a low battery and
needs to be charged. When the power indicator flashes, it means that the battery power is
extremely low. At this time, the pedal cannot work and needs to charge enough power to return
to normal. When the pedal is charging, the battery indicator will always be green, and it will
automatically turn off when it is fully charged.
3.2.3 Operation of foot control
After ensuring that the pedal has enough power and the handpiece is turned on, adjust the
handpiece to the pedal mode. At this time, step on the pedal to control the speed of the
handpiece.