Instructions for Use
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INSTRUCTION MANUAL SMART-PORT
Instruction manual SMART-PORT
INSTRUCTION MANUAL SMART-PORT
1250
Manufacturer: BPR Swiss GmbH Weststrasse 16 CH-3672 Oberdiessbach Switzerland Tel:
0041 31 506 06 06 E-Mail:[email protected]
Web:
www.bpr-swiss.com
EU Importer: BPR Swiss Europe GmbH Bergstedter Chaussee 122 D-22395 Hamburg Germany European Authorized Representative: managementsysteme Seiler Klaus Seiler Zum Saibling 3 D-88662 Überlingen / Lake Constance Germany
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Table of contents 1.
Symbols and signs used in the manual ... 4
2.
Type label / markings on the unit ... 5
3.
Safety precautions... 6
4.
Limitation of liability ... 7
5.
Precautions for electromagnetic compatibility (EMC) ... 8
6.
Intended Use / purpose regulations ... 12
7.
Combination with other products ... 13
8.
Storage and transport conditions ... 14
9.
Required skills and frequently used functions ... 15
10. Description of the SMART-PORT ... 16 11. Start-up ... 18 12. Operation... 20 13. Maintenance and cleaning ... 25 14. Technical specifications ... 28 15. Correcting malfunctions ... 28 16. Disposal advices... 29 17. Service ... 29 18. Accessories ... 30 19. Spare parts ... 30
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1. Symbols and signs used in the manual Danger The sections marked with this symbol contain instructions that must be followed to avoid damage to the unit and injury to the operator or patient.
Instructions These instructions must be followed exactly in order not to cause damage to the unit. Prohibition It is essential to refrain from these operations to avoid damage to the SMARTPORT. Advice These operations should be avoided at all costs to prevent damage to the unit. This symbol is affixed on the unit rating plate Meaning: Please observe the operating instructions when operating the unit.
This symbol is affixed on the unit rating plate Meaning: The information next to this symbol identifies the manufacturer of the product.
The CE mark shows that BPR Swiss has certified the use of a quality assurance system that meets the requirements of ANNEX V of Directive 1250 93/42 / EEC.
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2. Type label / markings on the unit The type label shows the essential technical data of the unit. The information on the type label must be kept available in case of service-related queries.
1 2
9
3
10
4 11
5
12 6
13
7 8
14
1. Manufacturer name, address and contact details 2. Disposal note 3. Type designation 4. Item number 5. Product designation 6. Year of manufacture 7. Technical specifications 8. UDI - Unique Device Identification 9. CE marking of the device (with number of the notified body) 10. Serial number 11. Unit weight 12. Unit dimensions 13. QR code / UDI machine readable 14. Read and observe the operating instructions
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3. Safety precautions Reading the operating instructions is mandatory. Read these operating instructions carefully before starting any work on the unit! They are part of the product and must be kept in the immediate vicinity of the unit and accessible to the operating and maintenance personnel at all times. These operating instructions contain important information on safety, operation and maintenance. Make this manual available to all persons responsible for the operation and maintenance of the device. A product training by the distributor is recommended. The requirement depends on the technical knowledge of the user. The user and/or patient must report all serious incidents related to the product to the manufacturer and the competent authority of the EU Member State in which the user and/or patient is established. No servicing is to be performed whilst the unit is attached to the electrical supply. The electrical supply must be interrupted whilst servicing is carried out. Work not described in the instruction manual must be carried out by qualified personnel (service personnel). During maintenance (for example replacement of parts not mentioned in the instruction manual) the safety of the device may be at risk.
Make sure that the power output and electrical voltage specification meet requirements stated in the instruction manual (Chapter on Technical data).
To avoid the risk of electric shock, the unit must only be connected to a mains supply with protective earthing. The mains plug is considered a disconnecting device. Make sure that the mains plug is easily accessible for the user. Avoid excessive pressing forces, because this causes damage of the cutting instruments and generates excessive heat. Excessive pressing forces are difficult to assess, as BPR Swiss GmbH cannot be held responsible for the safety and quality of the tools and for the way of using it by the dental professionals Page 6/30
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INSTRUCTION MANUAL SMART-PORT To avoid unwanted heat generation a sufficient cooling with an air/water spray has to be guaranteed. Insufficient water cooling is difficult to assess, as BPR Swiss GmbH cannot be held responsible for the safety and quality of the (rotating) instruments and tools and for the way they are used by the professional user. Insufficient water cooling causes irreversible damage of the tooth and tissue. In case of failure of the compressed air generation, the treatment must be stopped immediately. Insufficient water cooling is difficult to assess, as BPR Swiss GmbH cannot be held responsible for the safety and quality of the (rotating) instruments and tools and for the way they are used by the professional user. If there are signs of heating of the engine, the operator must immediately stop using the engine. In case of damaged aids such as contra-angle handpieces, LED function of the instruments, turbines or handpieces, the treatment must be interrupted and replacements must be provided. Electrical scalers must not be used on patients with a pacemaker. When using an electric dental scaler, please observe the corresponding accompanying documentation of the device. The effect of the temperature of the motor on the overheating of dental instruments is difficult to evaluate, therefore BPR Swiss cannot be held responsible for the safety of the (rotary) instruments and the way they are used by the professional user. Heavy or aggressive use and/or insufficient water cooling can create friction and thus lead to overheating of the (rotary) instruments.
4. Limitation of liability All information and notes in this manual have been compiled taking into account the applicable standards and regulations, the state of the art as well as our findings and experiences compiled. BPR Swiss GmbH accepts no liability for damage due to: Non-compliance with the user manual Non-intended use Use by untrained persons Use of spare parts that have not been approved by BPR Swiss GmbH Unauthorised modifications to the unit or accessories The General Terms and Conditions, as well as the Terms and Conditions of Delivery of BPR Swiss GmbH and the legal regulations valid at the time of the conclusion of the contract shall apply.
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5. Precautions for electromagnetic compatibility (EMC) Medical electrical equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in the present document. The SMART-PORT complies with the EMC requirements according to IEC 60601-1-2. Radio transmitting equipment, cellular phones, etc. shall not be used in the close proximity of the device since this could influence the performance of the device. Particular precaution must be considered during use of strong emission sources such as High Frequency surgical equipment and similar so that e.g. the HF cables are not routed Use of the SMART-PORT adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, the SMART-PORT and the other equipment should be observed to verify that they are operating normally. on or near the device. If in doubt, please contact a qualified technician or BPR Swiss. Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the SMART-PORT, including cables specified by the manufacturer. Otherwise, degradation of the performance of the SMART-PORT could result.
The use of accessories, transducers and cables other than those specified, with the exception of transducers and cables sold by BPR Swiss as replacements parts for internal components, may result in increased emissions or decreased immunity of the SMART-PORT.
Guidance and manufacturer’s declaration – electromagnetic emissions The SMART-PORT is intended for use in the electromagnetic environment specified below. The customer or the user of the SMART-PORT should assure that it is used in such an environment. Emission test RF emissions CISPR 11
RF emissions CISPR 11 Harmonic emissions IEC 61000-3-2 Voltage fluctuations/ flicker emissions IEC 61000-3-3
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Compliance Electromagnetic environment - guidance Group 1 The SMART-PORT uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. Class B The SMART-PORT is suitable for use in all establishments, including domestic establishments and those directly connected to Class A the public low-voltage power supply network that supplies buildings used for domestic purposes. Complies
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Guidance and manufacturer’s declaration – electromagnetic immunity The SMART-PORT is intended for use in the electromagnetic environment specified below. The customer or the user of the SMART-PORT should assure that it is used in such an environment. Immunity test Electrostatic discharge (ESD) IEC 61000-4-2 Electrical fast transient/burst IEC 61000-4-4
Surge IEC 61000-4-5
Voltage dips IEC 61000-411 Voltage interruptions IEC 61000-411
IEC 60601 test level ± 8 kV contact
± 8 kV contact
±15 kV air
±15 kV air
2 kV for power supply lines 100 kHz repetition frequency 1 kV for signal lines 100 kHz repetition frequency 1kV line(s) to line(s) 2kV line(s) to earth 0% UT for 0,5 cycle at 0°, 45°, 90°, 135°, 180°, 225°, 270°, 315°
2 kV for power supply lines 100 kHz repetition frequency 1 kV for signal lines 100 kHz repetition frequency
0% UT for 1 cycle at 0°
0% UT for 1 cycle at 0°
70% UT for 25/30 cycles at 0°
70% UT for 25/30 cycles at 0°
0% UT for 250/300 cycles at 0° 30 A/m / 50 Hz
0% UT for 250/300 cycles at 0°
Compliance level
1kV line(s) to line(s) 2kV line(s) to earth 0% UT for 0,5 cycle at 0°, 45°, 90°, 135°, 180°, 225°, 270°, 315°
Electromagnetic environment guidance Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. Mains power quality should be that of a typical commercial or hospital environment.
Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. If the user of the SMART-PORT requires continued operation during power mains interruptions, it is recommended that the SMART-PORT is powered from an uninterruptible power supply or battery.
Power 30 A/m / 50 Hz Power frequency magnetic fields frequency should be at levels characteristic of (50/60 Hz) a typical location in a typical magnetic field commercial or hospital IEC 61000-4-8 environment. NOTE: UT is the a.c. mains voltage prior to application of the test level.
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IEC 60601 test level 3V 150 kHz to 80MHz 6V in ISM radio band 150 kHz and 80 MHz 80% AM at 1 kHz
Compliance level 3V 150 kHz to 80MHz 6V in ISM radio band 150 kHz and 80 MHz 80% AM at 1 kHz
3 V/m 80 MHz to 2,7 GHz 80% AM at 1 kHz
3 V/m 80 MHz to 2,7 GHz 80% AM at 1 kHz
Proximity fields See table below form RF wireless communications equipment IEC 61000-4-3
See table below
Conducted RF IEC 61000-4-6
Radiated RF IEC 61000-4-3
NOTE 1 NOTE 2 a
b
Electromagnetic environment guidance Portable and mobile RF communications equipment should be used no closer to any part of the SMART-PORT, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance d = 1.2√P d = 1.2√P 80 MHz to 800 MHz d = 2.3√P 800 MHz to 2,5 GHz where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site surveya, should be less than the compliance level in each frequency rangeb. Interference may occur in the vicinity of equipment marked with the following symbol:
At 80 MHz and 800 MHz, the higher frequency range applies. These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
Field strengths from fixed transmitters, such as base stations for radio (cellular/ cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast cannot be predicted theoretically with accuracy. To assess the electro-magnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the SMART-PORT is used exceeds the applicable RF compliance level above, the SMART-PORT should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the SMART-PORT. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
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Proximity fields form RF wireless communications equipment IEC 61000-4-3 Test Frequency (MHz) Modulation Immunity test level (V/m) 385 Pulse 27 Modulation 18Hz FM 450 ±5 kHz deviation 28 1 kHz sine 710 Pulse 745 Modulation 9 780 217 Hz 810 Pulse 870 Modulation 28 930 18 Hz 1720 Pulse 1845 Modulation 28 1970 217Hz Pulse 2450 Modulation 28 217Hz 54240 Pulse 5500 Modulation 9 5785 217Hz
Recommended separation distances between portable and mobile RF communications equipment and the SMART-PORT The SMART-PORT is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the SMART-PORT can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the SMART-PORT as recommended below, according to the maximum output power of the communication equipment. Separation distance according to frequency of transmitter Rated maximum M output power of transmitter 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2,5 GHz W d = 1.2√P d = 1.2√P d = 2.3√P 0.01 0.12 0.12 0.23 0.1 0.38 0.38 0.73 1 1.2 1.2 2.3 10 3.8 3.8 7.3 100 12 12 23 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) 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) according to the transmitter manufacturer. NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
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6. Intended Use / purpose regulations The following section contains information on the intended purpose, indications, contraindications, undesirable side effects, warnings and precautions, patient group, intended user profile and the place of use of the BPR Swiss portable and mobile dental treatment units. For dental instruments and kits from third-party suppliers that can be attached to the portable and mobile dental treatment units, the corresponding information materials from these manufacturers must be consulted. General purpose The devices are transportable dental treatment units and serve for the general ambulant and stationary dental treatment. The devices are designed as a medical product exclusively to be used by a qualified user. All instruments delivered with the devices fulfil all demands of general dental treatments. The instructions in the instruction manual are mandatory for the choice of the place of treatment. Purpose SMART-PORT The device SMART-PORT is a transportable dental unit and serves for the general ambulant and stationary dental treatment. The device is designed as a medical product exclusively to be used by a qualified user. All instruments delivered with the device fulfil all demands of general dental treatments. The instructions in the instruction manual are mandatory for the choice of the place of treatment. Indications None Contraindication None Adverse effects None Warnings and precautions No servicing is to be performed whilst the unit is attached to the electrical supply. The electrical supply must be interrupted whilst servicing is carried out. Make sure that the power out-put and voltage specification meet requirements stated in the instruction manual (chapter on technical data). To avoid risk of electric shock, this equipment must only be connected to supply mains with protective earth. Electric dental scalers must not be used on patients with a pacemaker. If an electric dental scaler is used, please observe the corresponding accompanying documentation of the device. Patient Population The devices are intended to be used for the following patient population: Age groups: whole population Weight: no limitation Health states: patients with a pacemaker are excluded from treatment with scaling Nationalities: all nationalities Page 12/30
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INSTRUCTION MANUAL SMART-PORT Patient states: all patient states Disabled persons: no exception Intended user profile The devices are designed as medical devices that are exclusively used by qualified user. The intended users are professionals following the instructions of the manufacturer or persons assigned by the manufacturer. Typical users of the devices include dentists, dental hygienists, dental assistants, and technical service personnel. Use environment The devices are used in a clinical or practice environment or in other places suited for professional use in general outpatient and inpatient dental treatment. The dental carts and portable dental units may also be used bring dental care to patients who do not have the option to attend a dental practice (e.g., because of immobility, psychological / psychiatric disease, regional shortage of dental care, etc.). The use of the devices shall be commercial and not private. Claims There are no claims specific to clinical safety and / or performance of the devices.
7. Combination with other products The operator of the unit may only use original equipment. This applies in particular to the electric motor, the electric scaler and the scaler tips. Furthermore, only CE marked products may be used. This applies in particular to products from other manufacturers such as rotary instruments, saliva ejectors and the handpieces and contra-angles combined with the electric motor. The electric motor may be combined with handpieces and contra-angles from the motor manufacturer but also from other manufacturers with a standardized type E interface and CE marking. The following kits and instruments are intended for combination with the SMART-PORT. Number
Type
Manufacturer
D-23D001
Scaler
EMS
D-8007
Motor with light
Bien-Air
D-23B004
Electric scaler
Acteon
D-8013
Additional motor
Bien-Air
Air Flow Handpieces Contra-Angles
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8. Storage and transport conditions The unit is supplied by the manufacturer in transport packaging. This protects the unit against damage during transport. If possible, always use the original packaging for transport. Always transport the SMART-PORT in an upright position!
During transport and storage, the device must be protected from moisture, contamination and extreme temperatures. The SMART-PORT in its original packaging may only be stored in warm, dry and dust-free rooms.
If possible, keep the packaging material. If this is not possible, dispose of the packaging material in an environmentally friendly way. The transport box can be disposed of with the waste paper.
The suction unit may only be transported with an empty separation container. Be sure to empty the contents of the separation container before transport.
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9. Required skills and frequently used functions Required skills of operator: User group
Training
Knowledge
Language skills
Experience
Dentist
Professional University degree
Native language
Beginner to expert
Dental hygienist
Professional
Native language
Beginner to expert
Dental assistant
Professional
Native language
Beginner to expert
Technical service
Technician (Mechanics / Electronics)
Good knowledge of the system, trained Good knowledge of the system, trained Good knowledge of the system, trained Detailed technical knowledge of the system, trained
Native language
Beginner to expert
Frequently used functions: Name Dental procedure
Setting
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Designation Scaling Polishing Caries removal Dental bone shortening Shortening Email Teeth cutting Endo Adjusting ceramics Crown preparation Cavity preparation Suction Pressure adjustment for instruments Adjustment for suction
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10. Description of the SMART-PORT Front side SMART PORT 8
Back side SMART-PORT 13
10
14
9
16
5
17 19
7
6 2 1
18
20 15 11 4
12
3
SMART-PORT, Additional Motor
SMART-PORT, Air Flow
8 8 21
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10.1. Legend
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21
Pressure filter regulator with drain valve Quick coupling for suction Spray water bottle / Spray water bottle holder Clamping lever spray water bottle holder Suction hose Motor hose Three-way syringe Fine adjustment of spray water motor Spray water (on/off) Manometer (pressure indicator for instruments) Main switch (on/off) Shuttering Magnets Water fine adjustment Scaler Fine adjustment of scaler intensity Foot pedal connection Scaler hose Fine adjustment of suction intensity Display for electric motor with light Overflow stop plug Vacuum hose / connector Air Flow 21
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11. Start-up 1. The SMART-PORT is held so that the non-rotating handle points upwards.
2. a) The SMART-PORT is placed on a flat surface or b) The SMART-PORT is mounted on the Denta-Trolley. The complete connection can be verified by the “click” sound of the magnetic connection.
3. The four latches are opened and the lid is removed. 4. The clamping lever of the spray water bottle holder is loosened, the holder is turned to the front and the clamping lever is tightened again. The suction hose of the spray water bottle is inserted into the quick coupling of the spray water bottle holder. 5. The instrument hoses (Nr. 6,16) are hung in the holders provided for this purpose. 6. The foot pedal is preferably transported in the side pocket of the Denta-Trolley. It is connected to the SMART-PORT by inserting the hoses into the openings provided for this purpose (Foot pedal connection, No. 15). 7. The hoses of the three-way syringe (no. 7) are inserted into the couplings provided for this purpose and hung in the holder. To ensure optimum hygiene, the three-way syringe is preferably transported outside the SMART-PORT in a drawer of the Denta-Trolley.
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Note the colour coding for connecting the foot pedal and the three-way syringe!
8. The suction is connected to the rear side of the unit in the following order: 1. Vacuum hose/connector, No. 20 2. Quick coupling for suction, No. 2 3. Plug, No. 19 9. To ensure optimum hygiene, the micromotors are transportet outside the SMARTPORT preferably in a drawer of the Denta-Trolley. The micromotors have a coupling type E connection according to ISO 3964, so all contra-angles can be accomodated. 10. To ensure optimum hygiene, the handpiece of the scaler is preferably transported outside the SMART-PORT in a drawer of the Denta-Trolley. Only the tips of the manufacturer of the scaler should be used. 11. The water bottle is filled with water. If you have confidence in your tap water, you can consider using it. If you have concerns about the quality of the tap water, we recommend distilled water or water enriched with sterilizing concentrates (Water treatment). After filling, screw the water bottle into the holder. (Spray watter bottle / Spray water bottle holder, No. 3). 12. The power plug is plugged in. 13. The device is switched on via the main switch.
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12. Operation 12.1. Operation of the suction The suction is automatically activated as soon as the suction hose is removed from the holder.
Spittoons, saliva ejectors and surgical suction can be attached to the suction connection. It is sometimes necessary to use adapters when attaching the suction cannulas.
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