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Related Manuals for W&H Osstell ISQ
Summary of Contents for W&H Osstell ISQ
- Page 1 Instructions for Use Edition USA module Si-SQ...
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Page 2: Table Of Contents
Contents Symbols ........................................3 – 5 1. Introduction ......................................6 – 7 2. Electromagnetic compatibility (EMC) ..............................8 3. Equipment supplied ....................................9 4. Safety notes ....................................10 – 11 5. Description ......................................12 6. Start-up – General ....................................13 Operation ....................................... 14 – 16 8. -
Page 3: Symbols
Symbols in the Instructions for Use WARNING! ATTENTION! General explanations, (if persons could be injured) (if property could be damaged) without risk to persons or property Sterilizable Call customer service up to the stated temperature... - Page 4 Symbols on the Osstell ISQ module Consult Instructions for Use Type B applied part (not suitable Article number for intracardiac application) Serial number Date of manufacture CE mark with identification number XXXX of the Notified Body Supply voltage Do not dispose of with...
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Page 5: Symbols
Symbols on the packaging CE mark Data Matrix code with identification number for product information including UDI (Unique XXXX of the Notified Body Device Identification) This way up Data structure in accordance with Health Industry Bar Code Fragile, handle with care Permitted temperature range +70 °C (+158°F) Max. -
Page 6: Introduction
Intended use Osstell ISQ module is indicated for use in measuring the stability of implants in the oral cavity and craniofacial region. Osstell ISQ module can add important information to the evaluation of implant stability and can be used as part of an overall treatment evaluation program. -
Page 7: Introduction
> The Osstell ISQ module must be used in accordance 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 32). -
Page 8: Electromagnetic Compatibility (Emc)
2. Electromagnetic compatibility (EMC) Medical electrical equipment is subject to particular precautions with regards to EMC and must be installed and put into operation in accordance with the EMC notes included. W&H guarantees the compliance of the device with the EMC Directives only when used with original W&H accessories and spare parts. -
Page 9: Equipment Supplied
3. Scope of delivery Description 30210000 Osstell ISQ module 07849900 TestPeg 07721800 Universal support 07460300 SmartPeg mount... -
Page 10: Safety Notes
> Before using the Osstell ISQ module for the first time, store it at room temperature for 24 hours. > Check the Osstell ISQ module and the measuring probe with cable for damage and loose parts every time before use. - Page 11 Safety notes – general Danger zones M and G The Osstell ISQ module with the measuring probe is not suitable for use in potentially explosive atmospheres or with potentially explosive mixtures of anaesthetic substances containing oxygen or nitrous oxide according to IEC 60601-1/ANSI/ AAMI ES 60601-1.
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Page 12: Description
5. Description SmartPeg mount Osstell ISQ module Measuring probe connection TestPeg Measuring probe with cable USB cable... -
Page 13: Start-Up - General
6. Start-up – General 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! -
Page 14: Operation
7. Operation > The TestPeg is for testing only and for teaching in the function. > You can purchase SmartPegs from smartpegs.wh.com or osstell.com. > SmartPegs are for single use only. > SmartPegs are available for a range of different implant systems and can be used in combination with all conventionally available implants.* >... - Page 15 Operation Press the foot control pedal once to start the measurement. Press the foot control pedal again to stop the measurement early. Hold the measuring probe about 3 to 5 mm from the tip of the SmartPeg until the measured value is displayed.
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Page 16: Operation
Operation Measurement result* The measurement result can be used as part of a general assessment program. The user bears the ultimate responsibility for the decision for implant treatment. Low Stability Medium Stability High Stability Yellow Yellow Green ISQ <60 ISQ 60 – 65 ISQ 65 –... -
Page 17: Operation Documentation
8. Operation – documentation The ISQ values can only be documented in program 6. Documentation must be activated or deactivated for each program. A USB stick is required to save the documentation. Never remove the USB stick during the measurement. Record documentation >... -
Page 18: Operation Documentation
Operation – documentation Edit documentation A text file (csv) and a pdf file are saved on the USB stick. The text file can be opened in Microsoft® Excel* for editing. The pdf file can be opened in Adobe® Reader®**. * Microsoft® Excel® is a registered trademark of the Microsoft® Corporation in the United States of America and/or other countries. ** Adobe®... -
Page 19: Hygiene And Maintenance
9. Cleaning and Sterilization Follow your local and country-specific laws, directives, standards and guidelines for cleaning, disinfection and sterilization. > Wear protective clothing. > Clean and disinfect the measuring probe with cable immediately after every treatment! > Sterilize the measuring probe with cable after cleaning and disinfection. Medical device >... - Page 20 Cleaning and Sterilization > The Osstell ISQ module is not approved for mechanical cleaning (thermo washer disinfector) and sterilization. > Do not immerse the Osstell ISQ module in water or clean under running water. Pre-disinfection > If heavily soiled, clean first with disinfectant cloths.
- Page 21 Cleaning and Sterilization Do not twist or kink the cable! Do not coil it too tightly! Pre-disinfection > If heavily soiled, clean first with disinfectant cloths. Only use disinfectants which have no protein-fixing effect. Manual cleaning > Rinse and brush off with demineralized water (< 38°C) >...
- Page 22 Cleaning and Sterilization Sterilization and storage W&H recommends sterilization according to EN 13060, class B. Other sterilization methods may reduce the life span of your measuring probe. > Observe the manufacturer’s instructions for the autoclaves and sterilizers. > Clean and disinfect the measuring probe with cable before sterilization. >...
- Page 23 Cleaning and Sterilization Approved sterilization procedures Follow your local and country-specific laws, directives, standards and guidelines. > Dynamic-air-removal sterilizers: 270°F (132°C) for 4 minutes > Gravity displacement sterilizers: 270°F (132°C) for 15 minutes Do not exceed 277°F (136°C) during sterilization. Allow the load to dry for approximately 20 to 30 minutes before removing from the sterilizer.
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Page 24: W&H Accessories And Spare Parts
Use only original W&H accessories/spare parts or accessories approved by W&H. Reference source: W&H Partner 07721100 07849900 07721800 Measuring probe with cable* TestPeg Universal support 07460300 SmartPeg mount * The measuring probe with cable from Osstell is compatible with the W&H Osstell ISQ module. -
Page 25: Servicing
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 (see page 32). - Page 26 Servicing Repairs and returns In case of a fault or malfunction, send the Osstell ISQ module and the measuring probe with cable to an authorized W&H service partner (see page 32) for repair. > Always return equipment in the original packaging.
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Page 27: Technical Data
12. Technical data 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:... -
Page 28: Technical Data
Technical data 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 Class II medical electrical equipment Type B applied part (not suitable for intracardiac application) Pollution level: Overvoltage category: Altitude: up to 3,000 m above sea level... -
Page 29: Disposal
13. Disposal 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... -
Page 31: Explanation Of Warranty Terms
Ex p la na ti on o f war ranty ter ms This W&H product has been manufactured with great care by highly qualified specialists. A wide variety of tests and controls guarantees faultless operation. Please note that claims under warranty can only be validated when all the directions in the Instructions for Use have been followed. -
Page 32: Authorized W&H Service Partners
Authorized W&H service partners Visit W&H on the Internet at http://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. 14300 Henn Rd., Dearborn, MI 48126, USA t +1 800 265 6277, +1 519 944 6739 f +1 519 974 6121 E-Mail: service.us@wh.com... - Page 34 Manufacturer W&H Dentalwerk Bürmoos GmbH Ignaz-Glaser-Straße 53, 5111 Bürmoos, Austria Form no. 50875 AAE t +43 (0)6274 6236-0, f +43 (0)6274 6236-55 Rev. 001 / 31.10.2017 office@wh.com wh.com Subject to alterations...