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Summary of Contents for NSK Osseo 100+
- Page 1 Osseointegration Monitoring Device Osseo 100+ English OPERATION MANUAL Please read this OPERATION MANUAL carefully before use and file for future reference 55185 Rev. 1, March 2020 MADE IN SWEDEN...
- Page 2 Fig 1 Fig 2 Fig 3 Fig 4 Fig 5...
- Page 3 ENGLISH 1. Indications for Use Osseo 100+ is indicated for use in measuring the stability of implants in the oral cavity and craniofacial region. 2. Intended users Professional health care users and Professional health care facility environments only. Please read the instruction for use before the first usage. 3.
- Page 4 9. MulTipeg The MulTipeg is made from titanium, and has an integrated grip for the driver on top. Inspect the MulTipeg for damage before use. Damaged MulTipegs should not be used due to the risk of erroneous measurements. There are different MulTipegs available made to fit different implant systems and types. Please refer to the updated list from the supplier. Measurements should only be performed using the correct MulTipegs.
- Page 5 15.2 Autoclave sterilization (MulTipeg & MulTipeg Driver) Sterilization should be made in a pre-vacuum steam sterilizer (autoclave) according to ISO 17665-1. Clean the products and put them in an FDA-cleared (USA) autoclave bag before sterilization. The following sterilization process shall be used: At least 3 minutes at 134 (-1/+4)°C or 273(-1.6/+7.4)°F •...
- Page 7 21. EMC Information The instrument fulfils the requirements according to EN 60601-1-2 regarding emission and immunity. If sensitive electronic equipment is affected by the instrument, try to increase the distance to such equipment. The charger should not be connected during measurements. Guidance and manufacturer's declaration - Electromagnetic Emissions.
- Page 8 NSK Europe GmbH Elly-Beinhorn-Strasse 8, 6750 Escborn, Germany NSK France SAS 32 rue de Lisbone, 75008 Paris, France NSK United Kingdom Ltd Office 5, Gateway 1000, Arlington Business Park Whittle Way, Stevenage, SG1 2FP, UK NSK Dental Spain SA C/ Módena, 43 El Soho-Európolis...
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