38 Pages
Preview
Page 1
Instructions for Use
module SI-SQ
Contents Symbols... 3 1. Introduction... 6 2. Scope of delivery... 8 3. Safety notes... 9 4. Description... 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
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Symbols
in the Instructions for Use
WARNING! (if persons could be injured)
ATTENTION! (if property could be damaged)
General explanations, without risk to persons or property
Sterilizable up to the stated temperature
Thermo washer disinfectable
Type B applied part (not suitable for intracardiac application)
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Symbols
on the Osstell ISQ module CE marking with identification number of the Notified Body
Catalogue number
Manufacture
Medical Device
Serial number
Date of manufacture
Data Matrix code for product information including UDI (Unique Device Identification)
DC – direct current
Follow Instructions for Use XXXX
Do not dispose of with domestic waste
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Symbols XXXX
on the packaging
CE marking with identification number of the Notified Body
Data Matrix code for product information including UDI (Unique Device Identification)
Consult Instructions for Use
Medical Device
This way up
Data structure in accordance with Health Industry Bar Code
Fragile, handle with care
UL Component Recognition Mark indicates compliance with Canadian and U.S. requirements
Keep dry
80 %
8%
“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 Manufacturer Date of manufacture Catalogue number Serial number
Humidity limitation
+70 °C (+158°F) Max.
Temperature limitation
-40 °C (-40°F) Min.
Caution! Federal law restricts this device to sale by or on the order of a physician, dentist, veterinarian or with the descriptive designation of any other practitioner licensed by the law of the State in which the practitioner practices to use or order the use of the device. 5
1. Introduction For your safety and the safety of your patients These Instructions for Use explain how to use your product. However, we must also warn against possible hazardous situations. Your safety, the safety of your team and, of course, the safety of your patients, are of paramount importance to us.
Observe the safety notes. Intended use Osstell ISQ 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 patients, users and third parties. Qualifications of the user We have based our development and design of the medical device on the »physician« target group.
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Introduction Responsibility of the manufacturer The manufacturer can only accept responsibility for the safety, reliability and performance of the Osstell ISQ module when compliance with the following instructions is ensured: > 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. > Modifications 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 invalidate all claims made under warranty or otherwise. Any serious incident that has occurred in relation to the medical device should be reported to the manufacturer and the competent authority!
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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
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3. Safety notes
General
> Before using the medical device for the first time, store it at room temperature for 24 hours > Check the medical device for damage and loose parts every time before use. > Do not operate the medical device if it is damaged. > Perform a test measurement with the TestPeg prior to every use. > The responsibility 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 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). Hygiene and maintenance prior to initial use > Clean and disinfect the Osstell ISQ module and the measuring probe with cable. > Sterilize the measuring probe with cable. 9
4. Description
SmartPeg mount
Osstell ISQ module Measuring probe connection
TestPeg
USB cable 10
Measuring probe with cable
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!
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6. 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.* > Ensure that the sterile chain is not broken. > Only use SmartPegs with intact packaging.
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 finger force of approximately 4-6 Ncm. Do not overtighten the SmartPeg or the SmartPeg thread may be damage * For further information, please contact an authorized W&H service partner or visit osstell.com
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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.
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. a
The measured value is underlined in colour and confirmed by a signal tone.
b
Remove the SmartPeg with the SmartPeg mount. 13
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. 60
65
Low Stability
70
Medium Stability
High Stability
Red ISQ <60
Yellow ISQ 60 – 64
Yellow ISQ 65 – 69
Green ISQ ≥ 70
Implant at risk – monitor ISQ value
Full splint (immediate loading)
Partial case
Single case
Surgical protocol
2-stage
1- or 2-stage
1-stage
Restorative protocol
Traditional loading
Early loading
Immediate loading
Indication
This is a summary of scientific data and therefore does not represent an official recommendation. To monitor osseointegration, measurements should be taken after implant insertion and before restoration of the implant. Scientific studies can be found here: www.osstell.com ISQ value The 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. 14
* For further information, please contact an authorized W&H service partner or visit osstell.com
7. Hygiene and maintenance
General notes
Follow your local and national laws, directives, standards and guidelines for cleaning, disinfection and sterilization. > Wear protective clothing, safety glasses, face mask and gloves. > Use only oil-free, filtered compressed air with a maximum operating pressure of 3 bar for manual drying. Cleaning agents and disinfectants > Read the notes, follow the instructions and heed the warnings provided by the manufacturers of cleaning agents and/ or disinfectants. > Use only detergents 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, Mikrobiologie und Präventivmedizin (ÖGHMP = Austrian Society for Hygiene, Microbiology and Preventive Medicine), the Food and Drug Administration (FDA) and the U.S. Environmental Protection Agency (EPA). > The user is responsible for validating its process if the specified cleaning agents and disinfectants are not available. 15
Hygiene and maintenance
Limitations on processing
The product lifetime and the medical device’s ability to operate correctly are mainly determined by mechanical stress during 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.
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Hygiene and maintenance
Initial treatment at the point of use
Wipe 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.
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Hygiene and maintenance
Manual cleaning
Measuring probe with cable / Universal support Do not immerse the measuring probe with cable and the universal support in liquid disinfectant 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.
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Hygiene and maintenance
Manual disinfection
Measuring probe with cable / Universal 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).
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Hygiene and maintenance
Automated cleaning and disinfection
Universal support W&H recommends automated cleaning and disinfection using a washer-disinfector (WD). Read the notes, follow the instructions and heed the warnings provided by the manufacturers of washer‑disinfectors, cleaning agents and/or disinfectants. Evidence of the universal 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 probe with cable The Osstell ISQ module and the measuring probe with cable are not approved for automated cleaning and disinfection.
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