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Summary of Contents for Nouvag HighSurg 11 OFA-Drill
- Page 1 Instructions for use HighSurg 11 OFA-Drill for Orthopaedic Foot Surgery...
- Page 2 Vorwort Herzlichen Glückwunsch zum Kauf eines Produktes der Firma NOUVAG AG. Wir freuen uns, dass Sie sich für ein NOUVAG Erzeugnis entschieden haben und danken Ihnen für Ihr entgegengebrachtes Vertrauen. Diese Bedienungsanleitung wird Sie mit dem Gerät und seinen Eigenschaften vertraut machen, damit eine möglichst lange und problemlose Funktion gewährleistet werden kann.
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Page 3: Table Of Contents
Tubing set, Ref. 6024 Handpiece cradle Maintenance Replacing the control unit fuse Safety inspections Malfunctions and troubleshooting Spare parts list with order numbers Information on disposal OFA-Drill operating instructions, ref. 31595, V49/15 Instructions for use HighSurg 11 OFA-Drill • 31595 • V20220928... -
Page 4: Product Description
Consumable parts are not covered by the warranty. Improper use or repair, or failure to observe these instructions, relieve us from any obligation arising from warranty provisions or other claims. OFA-Drill operating instructions, ref. 31595, V49/15 Instructions for use HighSurg 11 OFA-Drill • 31595 • V20220928... -
Page 5: Explanation Of Symbols
(according to chapter 1.1 Intended use and operation), the manufacturer assumes no responsibility and the guarantee is void. OFA-Drill operating instructions, ref. 31595, V49/15 Instructions for use HighSurg 11 OFA-Drill • 31595 • V20220928... -
Page 6: Essential Requirements
In line with regulations pertaining to hazardous materials, the following items are not delivered with the control unit and must be ordered separately: 1984 Nou-Clean maintenance and care spray ---------------------------------------------------------------------- 1 unit OFA-Drill operating instructions, ref. 31595, V49/15 Instructions for use HighSurg 11 OFA-Drill • 31595 • V20220928... -
Page 7: Device Overview
23. Spray nozzle for maintenance of electronic motor 12. Peristaltic pump 24. Spray nozzle for handpiece maintenance 13. Tubing set Rear view 20 21 OFA-Drill operating instructions, ref. 31595, V49/15 Instructions for use HighSurg 11 OFA-Drill • 31595 • V20220928... -
Page 8: Startup
In order to prevent the risk of electric shock, the device may only be connected to a power network with a PE protective ground conductor. OFA-Drill operating instructions, ref. 31595, V49/15 Instructions for use HighSurg 11 OFA-Drill • 31595 • V20220928... -
Page 9: Device Preparation
Assemble the tubing set: For the cooling of the Handpiece fix the tube set Ref. 6024 in the tube compartment according to the following instructions. Use only Nouvag tube sets Ref. 6024, otherwise the correct function cannot be guaranteed. Check the expiry date of the tubing set and ensure that the packaging is not damaged. Using non-sterile tubing sets can result in serious infection and, in extreme cases, can be fatal. -
Page 10: Assembly Of External Irrigation System
3. Attach motor (not included in delivery) to the coupling flange. 4. Attach cable clip to the cable of the motor Ref. 1881 and suspend tubing. Ref. 1873 OFA-Drill operating instructions, ref. 31595, V49/15 Instructions for use HighSurg 11 OFA-Drill • 31595 • V20220928... -
Page 11: Operation
By pressing both “Pump” keys at the same time “Pump ▲ + ▼” the pump will be put on call, pressing again • will switch it off. OFA-Drill operating instructions, ref. 31595, V49/15 Instructions for use HighSurg 11 OFA-Drill • 31595 • V20220928... -
Page 12: Overview: Standard Display
Bar graph providing a graphical representation of the current torque. All bars active means max. torque reached. The pump does not begin to operate until the motor has been activated by pressing the pedal. OFA-Drill operating instructions, ref. 31595, V49/15 Instructions for use HighSurg 11 OFA-Drill • 31595 • V20220928... -
Page 13: Adjusting The Programs
4 : 1 12,000 Micro oszillating saw Micro saw fix 15,000 fix 6 Micro sagittal saw Micro compass saw K-Wire handpiece Kirschner Hp 2,800 fix 48 OFA-Drill operating instructions, ref. 31595, V49/15 Instructions for use HighSurg 11 OFA-Drill • 31595 • V20220928... -
Page 14: Step 2: Testing The Handpieces
Press the “Speed” keys “▲” to increase or “▼” to decrease the maximum speed. When key is pressed continuously the speeds will be shown in fast forward mode. OFA-Drill operating instructions, ref. 31595, V49/15 Instructions for use HighSurg 11 OFA-Drill • 31595 • V20220928... -
Page 15: Step 4: Setting The Torque
For the micro saws only the amount of coolant liquid can be altered. By pressing both „HP + PR“-keys at the same time the memory slots can be reset to the factory default settings. OFA-Drill operating instructions, ref. 31595, V49/15 Instructions for use HighSurg 11 OFA-Drill • 31595 • V20220928... -
Page 16: Torque Limiter
When the OFA-Drill device is switched on, the display shows always the last used settings. By pressing both „HP + PR“-keys at the same time the memory slots can be reset to the factory default settings. OFA-Drill operating instructions, ref. 31595, V49/15 Instructions for use HighSurg 11 OFA-Drill • 31595 • V20220928... -
Page 17: Operation Using The Vario Pedal
(speed as set on the control unit) (speed as set on the control unit) For safety reasons, the unit can only be operated by pedal. OFA-Drill operating instructions, ref. 31595, V49/15 Instructions for use HighSurg 11 OFA-Drill • 31595 • V20220928... -
Page 18: Functional Check
OFA-Drill operating instructions, ref. 31595, V49/15 Instructions for use HighSurg 11 OFA-Drill • 31595 • V20220928... -
Page 19: Cleaning, Disinfection And Sterilization
Wipe the outside using micro-biologically tested surface disinfectant or a 70 % isopropyl alcohol solution. The front plate of the control unit is sealed for this purpose and can be wiped clean. OFA-Drill operating instructions, ref. 31595, V49/15 Instructions for use HighSurg 11 OFA-Drill • 31595 • V20220928... -
Page 20: Electronic Motor
If a drying program is not provided by the washer-disinfector, the electronic motor must be dried manually or in a drying cabinet. The handpiece holder must then be screwed back onto the motor. OFA-Drill operating instructions, ref. 31595, V49/15 Instructions for use HighSurg 11 OFA-Drill • 31595 • V20220928... -
Page 21: Tubing Set, Ref. 6024
The effectiveness of the sterilization instructions provided above for electronic motor 21 and the handpiece has been validated by Nouvag AG. The user is responsible for ensuring that the sterilization procedure performed achieves the required result. This requires validation and routine monitoring of the procedure. -
Page 22: Maintenance
An inspection interval of 2 2 y y e e a a r r s s applies to the OFA-Drill. NOUVAG AG offers a safety inspection service for its customers. Addresses can be found in the appendix of this operation manual under “Service centers”. For further information please contact our technical service department. -
Page 23: Malfunctions And Troubleshooting
If a fault cannot be rectified, please contact your supplier or an authorized service centre. The addresses are provided on the last page of the operating instructions. OFA-Drill operating instructions, ref. 31595, V49/15 Instructions for use HighSurg 11 OFA-Drill • 31595 • V20220928... - Page 24 The red background coloured error messages on this list above are also on display illuminated red. The other messages have informal character and don’t require an action from the user. OFA-Drill operating instructions, ref. 31595, V49/15 Instructions for use HighSurg 11 OFA-Drill • 31595 • V20220928...
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Page 25: Spare Parts List With Order Numbers
Motors must be sterilized before disposal. Please observe currently valid national disposal regulations for infectious waste. Contaminated single-use tubing sets are subject to specific disposal requirements. Please observe currently valid national disposal regulations for infectious waste. OFA-Drill operating instructions, ref. 31595, V49/15 Instructions for use HighSurg 11 OFA-Drill • 31595 • V20220928... - Page 26 Instructions for use HighSurg 11 OFA-Drill • 31595 • V20220928...
- Page 27 Anhang Appendix Appendice Appendice Apéndice Appendix Aneks Apendix Appendix Függelék...
- Page 28 Electromagnetic compatibility (EMC) Remark: The Product subsequently referred to herein always denotes the HighSurg OFA-Drill. Changes or modifications to this product not expressly approved by the manufacturer may result in increased emissions or decreased immunity performance of the product and could cause EMC issues with this or other equipment. This product is designed and tested to comply with applicable regulations regarding EMC and shall be installed and put into service according to the EMC information stated as follows.
- Page 29 Guidance and manufacturer’s declaration – electromagnetic immunity for not life support equipment The Product is intended for use in the electromagnetic environment specified below. The customer or the user of the Product should assure that it is used in such an environment. Immunity tests IEC 60601 Compliance level...
- Page 31 Nouvag GmbH • Schulthaissstrasse 15 • DE-78462 Konstanz Phone +49 7531 1290 - 0 info-de@nouvag.com • www.nouvag.com A complete list of Nouvag certified service centers are found on the Nouvag website at: www.nouvag.com/service Post market surveillance In the event of problems with the product or in the event of a serious incident, please immediately download, compile and send the following form https://nouvag.com/media/attachments/2022/05/19/for_8-308.pdf...
- Page 32 Nouvag AG • St.Gallerstrasse 25 • CH-9403 Goldach Tel. +41 71 846 66 00 info@nouvag.com • www.nouvag.com Nouvag GmbH • Schulthaissstrasse 15 • DE-78462 Konstanz Tel. +49 7531 1290 - 0 info-de@nouvag.com • www.nouvag.com...
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