Pac-Dent PMCL-100, Instruction Manual

Page 1: ...Instruction Manual Please carefully read instruction manual before first use 670 Endeavor Circle Brea CA 92821 909 839 0888 info pac dent com www pac dent com 08IFUPMCL100 Rev 050421...

Page 2: ...tallation 3 Function Operation of Product 4 Operation Instruction 5 Troubleshooting 6 Cleaning Disinfection Sterilization 7 Storage Maintenance Transportation 8 Environmental Protection 9 After Sales...

Page 3: ...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 qualit...

Page 4: ...d 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...

Page 5: ...deral 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 t...

Page 6: ...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 disab...

Page 7: ...ic 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 ca...

Page 8: ...rs 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 y...

Page 9: ...ter 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...

Page 10: ...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 Pr...

Page 11: ...ioned 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 pat...

Page 12: ...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...

Page 13: ...vel 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 bat...

Page 14: ...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...

Page 15: ...15 1 15 Environment parameters Environment temperature 5 40 Relative humidity 30 75 Atmospheric pressure 70 106kPa...

Page 16: ...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 PMC...

Page 17: ...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 i...

Page 18: ...ully 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...

Page 19: ...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...

Page 20: ...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 batter...

Page 21: ...4 Post op After the treatment stop the handpiece first and then remove the Disposable Prophy Angle disposable barrier and outer sheath Carry out high temperature and high pressure sterilization on th...

Page 22: ...ot control Charge the wireless foot control directly with the original power adapter For safety reasons the motor cannot be started when charging Please use the original power adapter for charging Oth...

Page 23: ...tion during operation 1 Ensure that the outer sheath and the Disposable Prophy Angle are snapped together securely 2 Ensure that the Motor Component and the outer sheath are snapped together securely...

Page 24: ...t use bleach or chloride based disinfectant materials 6 2 4 For your own safety please wear personal protective equipment gloves glasses mask 6 2 6 The user is responsible for the sterility of the pro...

Page 25: ...ecific steps are as follows 6 3 1 1 Manual cleaning steps 1 Take out the motor component power adapter and charging base on the workbench 2 Wet the soft cloth completely with distilled water or deioni...

Page 26: ...emperature and time specified by the disinfectant manufacturer After cleaning and disinfecting the motor component you must install a disposable barrier before use and repeat steps 1 2 and 3 to clean...

Page 27: ...xytech from Germany but you must respect the concentration temperature and time specified by the disinfectant manufacturer 6 4 The cleaning disinfection and sterilization of Outer Sheath unless otherw...

Page 28: ...dated parameters are adhered to during every cycle Please also observe the applicable legal requirements in your country as well as the hygiene regulations of the hospital or clinic especially with re...

Page 29: ...e for the product and the irrigating period is sufficient It is recommended to use a washer disinfectant in accordance with EN ISO 15883 For the specific procedure please refer to the automated disinf...

Page 30: ...h EN ISO 15883 Use a high temperature disinfection function The temperature should not exceed 134 C 273 F and the disinfection under the temperature cannot exceed 20 minutes The disinfection cycle is...

Page 31: ...water deionized water or multi enzyme solution etc and only freshly prepared solutions can be used c4 With the use of cleaner the concentration and time provided by manufacturer shall be obeyed The u...

Page 32: ...ormed in a clean place The drying temperature should not exceed 138 C 280 F The equipment used should be inspected and maintained regularly 6 4 6 Inspection and maintenance 6 4 6 1 Inspection In this...

Page 33: ...g 6 4 8 Sterilization 6 4 6 1 Inspection Use only the following steam sterilization procedures fractional pre vacuum procedure for sterilization and other sterilization procedures are prohibited The s...

Page 34: ...tion procedures that have not been recommended please adhere to related effective standards and verify the suitability and effectiveness Fractional pre vacuum procedure steam sterilization with repeti...

Page 35: ...ation 1 Prevent excessive shock and vibration during transportation and handle with care 2 It should not be mixed with dangerous goods during transportation 3 Avoid exposure to sun or rain or snow dur...

Page 36: ...ent increases to a normal level there will be dew that will possibly damage the PCB board 7 2 Maintenance 7 2 1 This device does not include accessories for repair The repair should be carried out by...

Page 37: ...ng transportation 7 3 3 Avoid solarization and getting it wet in rain and snow during transportation 8 Environmental Protection Please dispose according to the local laws 9 After Sales Service From th...

Page 38: ...Class II Equipment Used Indoor Only Recovery Handle With Care Keep Dry CE Marked Product Humidity Limitation Appliance Compliance WEEE Directive Protection Class IPX0 IPX0 Classification Of Ingress Of...

Page 39: ...12 Statement All rights of modifying the product are reserved to the manufacturer without further notice The pictures are only for reference 13 EMC Declaration of Conformity The device has been teste...

Page 40: ...gnetic environment guidance RF emissions CISPR 11 Group 1 The model ProMate CL uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any int...

Page 41: ...uidance Electrostatic Discharge ESD IEC 61000 4 2 8kV contact 2 4 8 15kVair 8kV contact 2 4 8 15kVair Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the r...

Page 42: ...Mate CL requires continued operation during power mains interruptions it is recommended that the model ProMate CL be powered from an uninterruptible power supply or a battery Power frequency 50 60 Hz...

Page 43: ...6V 3V m Portable and mobile RF communications equipment should be used no closer to any part of the ProMate CL including cables than the recommended separation distance calculated from the equation ap...

Page 44: ...ios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic s...

Page 45: ...he user of the model ProMate CL can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the model ProMa...

Page 46: ...can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W accordable to the transmitter manufacturer N...

Page 47: ...ice pursuant to Part 15 of the FCC Rules and has been tested and found to comply with the limits for a wireless power charger pursuant to Part 18 of the FCC Rules These limits are designed to provide...

Page 48: ...Visit Pac Dent s website for more information www pac dent com Pac Dent Inc 670 Endeavor Circle Brea CA 92821 909 839 0888 info pac dent com www pac dent com Manufactured for...