W&H Osstell ISQ Скачать руководство пользователя страница 31 | Manualshive

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W&H Osstell ISQ Скачать руководство пользователя страница 31

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11. Data on electromagnetic compatibility according to IEC/EN 60601-1-2

Operating environment and EMC warning notes

This medical device is neither life-sustaining nor coupled to the patient. It is suitable for operation both in domestic

healthcare and in facilities used for medical purposes except rooms/areas, in which EMC interference of highintensity
may occur. The customer and/or the user should assure that this medical device is set up and used in an
environment of the specified type and/or in accordance with the specifications of the manufacturer.

This medical device uses RF energy only for its internal functions. Therefore, its RF emissions are very low and not

likely to cause any interference in nearby electronic equipment.

No special precautions are necessary to maintain the basic safety and essential performance of this medical device.

Essential performance

This medical device has no critical functions and therefore does not have any essential performance features.

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Содержание Osstell ISQ

Страница 1: ...Instructions for Use module SI SQ ...

Страница 2: ... 10 5 Start up 11 6 Operation 12 7 Hygiene and maintenance 15 8 Servicing 26 9 W H accessories and spare parts 28 10 Technical data 29 11 Data on electromagnetic compatibility according to IEC EN 60601 1 2 31 12 Disposal 35 Explanation of warranty terms 36 Authorized W H service partners 37 ...

Страница 3: ...ersons could be injured ATTENTION if property could be damaged General explanations without risk to persons or property Type B applied part not suitable for intracardiac application Sterilizable up to the stated temperature Thermo washer disinfectable ...

Страница 4: ... Serial number DC direct current Data Matrix code for product information including UDI Unique Device Identification Do not dispose of with domestic waste Follow Instructions for Use CE marking with identification number of the Notified Body XXXX Manufacture Medical Device ...

Страница 5: ... The Green Dot trademark of Duales System Deutschland GmbH Trademark of RESY OfW GmbH for identification of recyclable transport and outer packaging of paper and cardboard 40 C 40 F Min 70 C 158 F Max 8 80 CE marking with identification number of the Notified Body XXXX Data structure in accordance with Health Industry Bar Code Data Matrix code for product information including UDI Unique Device Id...

Страница 6: ...is indicated for use in measuring the stability of implants in the oral cavity and craniofacial region Osstell ISQ can add important information to the evaluation of implant stability and can be used as part of an overall treatment evaluation program The final implant treatment decisions are the responsibility of the user Misuse may damage the medical device and hence cause risks and hazards for p...

Страница 7: ...ions or repairs must only be undertaken by an authorized W H service partner see page 37 Unauthorized opening of the unit invalidates all claims under warranty and any other claims In addition to unauthorized assembly installation modification of or repairs to the Osstell ISQ module and measuring probe with cable transmission instrument and non compliance with our instructions improper use will in...

Страница 8: ...8 2 Scope of delivery Osstell ISQ module 30210000 07849900 TestPeg x 07721800 Universal support x 07460300 SmartPeg mount x 07721100 Measuring probe with cable x ...

Страница 9: ...of the system lies with the user Ensure that it is possible to complete the operation safely should the units or instruments fail The medical device is not approved for operation in potentially explosive atmospheres Do not twist or kink the cable Do not coil it too tightly The medical device is classed as conventional equipment closed equipment without protection against the ingress of water Hygie...

Страница 10: ...10 4 Description TestPeg Osstell ISQ module Measuring probe connection USB cable Measuring probe with cable SmartPeg mount ...

Страница 11: ...11 5 Start up General Push in the Osstell ISQ module until it engages audibly Pay attention to the positioning of the USB cable Connect USB Connect measuring probe Pay attention to the positioning ...

Страница 12: ...kaging Select ISQ program The ISQ program always appears after the last program Pull a thread through the SmartPeg mount Tie the thread to your wrist to prevent loss Insert the SmartPeg into the SmartPeg mount The SmartPeg is magnetic and is held in place by SmartPeg mount Check that it is retained secure hold Attach the SmartPeg to the implant or abutment by screwing the SmartPeg mount using fing...

Страница 13: ...obe about 3 to 5 mm from the tip of the SmartPeg until the measured value is displayed Measure in both the mesiodistal direction a and the buccolingual direction b Do not measure from above Repeat 5 and 6 to perform multiple measurements The measured value is underlined in colour and confirmed by a signal tone Remove the SmartPeg with the SmartPeg mount b a ...

Страница 14: ...he resonance frequency as a measure of implant stability is calculated from the response signal of the SmartPeg The results of this calculation are displayed as the ISQ value The scale from the ISQ value ranges from 1 to 100 For further information please contact an authorized W H service partner or visit osstell com Operation Low Stability Medium Stability High Stability 60 70 Red ISQ 60 Implant ...

Страница 15: ...which are intended for cleaning and or disinfecting medical devices made of metal and plastic It is imperative to comply with the concentrations and exposure times specified by the manufacturer of the disinfectant Use disinfectants which have been tested and found effective by the Verbund für Angewandte Hygiene e V VAH Association for Applied Hygiene the Österreichischen Gesellschaft für Hygiene M...

Страница 16: ... use and chemical influences due to processing Send worn or damaged medical devices and or medical devices with material changes to an authorized W H service partner Processing cycles We recommend a regular service for the measuring probe with cable after 250 processing cycles or one year We recommend a regular service for the W H universal support after 250 processing cycles ...

Страница 17: ...ipe the Osstell ISQ module the measuring probe with cable and the universal support and the irrigant support with disinfectant Note that the disinfectant used during pre treatment is only for personal protection and cannot replace the disinfectant step after cleaning ...

Страница 18: ...infectant or in an ultrasonic bath Measuring probe with cable Universal support Clean the measuring probe with cable and the universal support under running tap water 35 C 95 F Rinse and brush off all internal and external surfaces Remove liquid residues using compressed air Osstell ISQ module Do not immerse the Osstell ISQ module in water or clean them under running water ...

Страница 19: ... support W H recommends wipe down disinfection Evidence of the basic suitability measuring probe with cable and the universal support for effective manual disinfection was provided by an independent test laboratory using the mikrozid AF wipes disinfectant Schülke Mayr GmbH Norderstedt ...

Страница 20: ...niversal support basic suitability for effective automated disinfection was provided by an independent test laboratory using the Miele PG 8582 CD washer disinfector Miele Cie KG Gütersloh and the Dr Weigert neodisher MediClean forte cleaning agent Dr Weigert GmbH Co KG Hamburg according to ISO 15883 Cleaning at 55 C 131 F 5 minutes Disinfection at 93 C 200 F 5 minutes Osstell ISQ module Measuring ...

Страница 21: ... Measuring probe with cable Universal support Ensure that the measuring probe with cable and the universal support are completely dry internally and externally after cleaning and disinfection Remove liquid residues using compressed air ...

Страница 22: ...easuring probe with cable and the universal support after cleaning and disinfection for damage visible residual soiling and surface changes Reprocess any measuring probe with cable and the universal support that are still soiled Sterilize the measuring probe with cable and the universal support following cleaning and disinfection ...

Страница 23: ...ization packages that meet the following requirements The sterilization package must meet the applicable standards in respect of quality and use and must be suitable for the sterilization procedure The sterilization package must be large enough for the sterilization goods The loading sterilization package must not be under tension ...

Страница 24: ...es 132 C 270 F for at least 4 minutes Maximum sterilization temperature 135 C 275 F Evidence of the medical device s basic suitability for effective sterilization was provided by an independent test laboratory using the LISA 517 B17L steam sterilizer W H Sterilization S r l Brusaporto BG and the Systec VE 150 steam sterilizer Systec Dynamic air removal prevacuum cycle type B 134 C 273 F 3 minutes ...

Страница 25: ...and maintenance Storage Measuring probe with cable Universal support SmartPeg mount Store sterile goods dust free and dry The shelf life of the sterile goods depends on the storage conditions and type of packaging ...

Страница 26: ...ction and safety of the medical device is necessary and should be carried out at least once every three years unless shorter intervals are prescribed by law The periodic inspection covers the complete medical device and must only be performed by an authorized service partner ...

Страница 27: ...ner Repairs and maintenance work must only be undertaken by an authorized W H service partner Ensure that the medical device has been completely processed before returning it Always return equipment in the original packaging Do not coil the cable around the measuring probe and do not twist or kink the cable Risk of damage ...

Страница 28: ...ries and spare parts or accessories approved by W H Suppliers W H partners 07721100 Measuring probe with cable 07849900 TestPeg The measuring probe with cable from Osstell is compatible with the W H Osstell ISQ module 07721800 Universal support 07460300 SmartPeg mount ...

Страница 29: ... 8 to 80 relative non condensing Temperature in operation 10 C to 35 C 50 F to 95 F Air Humidity in operation 15 to 80 relative non condensing Osstell ISQ module SI SQ Voltage from Implantmed 5 5 V Dimensions in mm height x width x depth 79 x 138 x 88 Weight in kg 0 210 kg TestPeg measured value tolerance 55 5 SmartPeg measured value tolerance 1 ...

Страница 30: ...ical electrical device protective earth conductor used for functional earth connection only Type B applied part not suitable for intracardiac application Classification according to Paragraph 6 of the General Specifications for the Safety of Medical Electrical Device according to IEC 60601 1 ANSI AAMI ES 60601 1 ...

Страница 31: ...ser should assure that this medical device is set up and used in an environment of the specified type and or in accordance with the specifications of the manufacturer This medical device uses RF energy only for its internal functions Therefore its RF emissions are very low and not likely to cause any interference in nearby electronic equipment No special precautions are necessary to maintain the b...

Страница 32: ...d with original W H accessories and spare parts The use of accessories and spare parts not approved by W H can lead to an increased emission of electromagnetic interference or to a reduced resistance against electromagnetic interference Use of this medical device adjacent to or stacked with other equipment should be avoided because it could result in improper operation If such use is necessary thi...

Страница 33: ...etic interference Electrostatic discharge ESD IEC EN 61000 4 2 Contact discharge 2 kV 4 kV 6 kV 8 kV Air discharge 2 kV 4 kV 8 kV 15 kV Radiated RF electromagnetic field IEC EN 61000 4 3 80 MHz 2 7 GHz 10 V m Proximity fields from RF wireless communications equipment IEC EN 61000 4 3 385 MHz 27 V m 450 MHz 28 V m 710 745 780 MHz 9 V m 810 870 930 MHz 28 V m 1720 1845 1970 MHz 28 V m 2450 MHz 28 V ...

Страница 34: ...nducted disturbances induced by RF fields IEC EN 61000 4 6 3 V 6 V in ISM bands 6 V in amateur radio bands Power frequency magnetic field IEC EN 61000 4 8 30 A m Surges IEC EN 61000 4 5 Voltage dips voltage interruptions IEC EN 61000 4 11 There are no deviations or simplifications to IEC 60601 1 2 ...

Страница 35: ... 12 Disposal Ensure that the parts are not contaminated on disposal Follow your local and national laws directives standards and guidelines for disposal Medical device Waste electrical equipment Packaging ...

Страница 36: ...rer W H is liable for material or manufacturing defects within a warranty period of 12 24 months from the date of purchase 12 months Measuring probe with cable 24 months Osstell ISQ module We accept no responsibility for damage caused by incorrect handling or by repairs carried out by third parties not authorized to do so by W H Claims under warranty accompanied by proof of purchase must be sent t...

Страница 37: ...37 Authorized W H service partners Find your nearest authorized W H service partner at http wh com Simply go to the menu option Service for full details Or simply scan the QR code ...

Страница 38: ...Manufacturer W H Dentalwerk Bürmoos GmbH Ignaz Glaser Straße 53 5111 Bürmoos Austria t 43 6274 6236 0 f 43 6274 6236 55 office wh com wh com Form Nr 50875 AEN Rev 005 01 10 2021 Subject to alterations ...

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