Osstell ISQ Si-SQ Instructions For Use Manual Download Page 36 | Manualshive

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Manufacturer’s declaration

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Summary of Contents for ISQ Si-SQ

Page 1: ...module Si SQ Instructions for Use Edition USA ...

Page 2: ...elivery 9 4 Safety notes 10 5 Description 11 6 Start up 12 7 Operation 13 8 Hygiene and maintenance 16 9 Servicing 27 10 W H accessories and spare parts 29 11 Technical data 30 12 Disposal 32 Explanation of warranty terms 34 Authorized W H service partners 35 Manufacturer s declaration 36 ...

Page 3: ...sons could be injured ATTENTION if property could be damaged General explanations without risk to persons or property Call customer service Sterilizable up to the stated temperature Symbols in the Instructions for Use ...

Page 4: ...r intracardiac application Do not dispose of with domestic waste Data Matrix code for product information including UDI Unique Device Identification CE mark with identification number of the Notified Body XXXX Symbols on the Osstell ISQ module DC direct current Follow Instructions for Use ...

Page 5: ... Keep dry Permitted temperature range Humidity Limitation Der Grüne Punkt 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 mark with identification number of the Notified Body XXXX Data structure in accordance with Health Industry Bar Code D...

Page 6: ...ated 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 Osstell ISQ module and hence cause risks and hazards for patie...

Page 7: ...ce with these Instructions for Use The Osstell ISQ module has no components that can be repaired by the user Assembly modifications or repairs must only be undertaken by an authorized W H service partner see page 35 Unauthorized opening of the equipment invalidates all claims under warranty and any other claims In addition to unauthorized assembly installation modification of or repairs to the Oss...

Page 8: ...HF communications equipment including peripherals such as antenna cables and external antennas should be used no closer than 30 cm 12 inches to the medical device Otherwise degradation of the performance of this medical device could result The medical device may be interfered by other equipment even if these other devices comply with CISPR International special committee on radio interference emis...

Page 9: ...9 3 Scope of delivery REF Description 30210000 Osstell ISQ module 07849900 TestPeg 07721800 Universal support 07460300 SmartPeg mount ...

Page 10: ...ility for the use and timely shutdown of the system lies with the user Ensure that it is possible to complete the operation safely should the units or instruments fail The Osstell ISQ module is not approved for operation in potentially explosive atmospheres Do not twist or kink the cable Do not coil it too tightly The Osstell ISQ module is classed as conventional equipment closed equipment without...

Page 11: ...11 5 Description TestPeg Osstell ISQ module Measuring probe connection USB cable Measuring probe with cable SmartPeg mount ...

Page 12: ...12 Push in the Osstell ISQ module until it locks audibly Pay attention to the positioning of the USB cable Connect USB Connect measuring probe Pay attention to the positioning 6 Start up General ...

Page 13: ...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...

Page 14: ...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 ...

Page 15: ...he resonance frequency as a measure of implant stability is calculated from the oscillation frequency 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 Im...

Page 16: ...nded 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 Mikrobiologie u...

Page 17: ...es 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 Limitations on processing ...

Page 18: ...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 ...

Page 19: ...isinfectant 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 under running water ...

Page 20: ... 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 ...

Page 21: ...ry 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 probe with cable The Osstell ISQ module and the measuring probe with cable are not approved for automated cleaning a...

Page 22: ...easuring 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 any liquid residues using compressed air ...

Page 23: ...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 ...

Page 24: ...t in sterilization 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 ...

Page 25: ...S Sterilization time at 3 minutes at 134 C 273 F 4 minutes at 132 C 270 F Maximum sterilization temperature 135 C 275 F Evidence of the measuring probe with cable and the universal support 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 ...

Page 26: ...ygiene and maintenance Storage Measuring probe with cable Universal support Store sterile goods dust free and dry The shelf life of the sterile goods depends on the storage conditions and type of packaging ...

Page 27: ...e prescribed by law The inspection must be undertaken by a qualified organization and must include the following procedures Osstell ISQ module External visual inspection Visual inspection of internal components on suspicion of safety interference e g mechanical damage of the enclosure or indicators of overheating The regular inspection must only be performed by an authorized W H service partner ...

Page 28: ...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 ...

Page 29: ...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 ...

Page 30: ... 8 to 80 relative non condensing Temperature in operation 10 C to 35 C 50 F to 95 F 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 ...

Page 31: ... m above sea level Class II medical electrical equipment Type B applied part not suitable for intracardiac application Classification according to Paragraph 6 of the General Specifications for the Safety of Medical Electrical Equipment according to IEC 60601 1 ANSI AAMI ES 60601 1 ...

Page 32: ...l Ensure that the parts are not contaminated on disposal Follow your local and country specific laws directives standards and guidelines for disposal Waste electrical equipment Accessories and spare parts Packaging ...

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Page 34: ... been followed As the manufacturer W H is liable for material or manufacturing defects within a warranty period of 24 months from the date of purchase 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 to the vendor or to an authorized W H s...

Page 35: ...ttp wh com You can find your nearest W H service partner under Service in the menu If you do not have Internet access please contact W H Impex Inc 33091 W Jefferson Ave Brownstown MI 48173 USA t 1 800 265 6277 1 519 944 6739 f 1 519 974 6121 E Mail service us wh com ...

Page 36: ...36 Manufacturer s declaration ...

Page 37: ...37 Manufacturer s declaration ...

Page 38: ...38 Manufacturer s declaration ...

Page 39: ...39 Manufacturer s declaration ...

Page 40: ...anufacturer W H Dentalwerk Bürmoos GmbH Ignaz Glaser Straße 53 5111 Bürmoos Austria t 43 0 6274 6236 0 f 43 0 6274 6236 55 office wh com wh com Form no 50875 AAE Rev 003 05 04 2019 Subject to alterations ...

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