Table of Contents
Advertisement
Quick Links
Advertisement
Table of Contents
Related Manuals for hbw RIGENERA
Summary of Contents for hbw RIGENERA
- Page 1 RECHARGEABLE SICURDRILL USER’S MANUAL Rev. 02-2024...
- Page 2 Table of revision Rev. Description Revision according to Regulation (EU) 2017/745 on medical devices Revision for change of operative site and update of Electrical safety and EMC report Translation of original instructions Human Brain Wave S.r.l. Contacts: Registered office: C.so Galileo Ferraris, 63 – 10128 Torino, Italy Operational headquarters and offices: Via Sestriere, 17 –...
-
Page 3: Safety Precautions
Use this device correctly and safely READ THIS MANUAL BEFORE This user’s manual includes operating procedures, safety precautions specifications for rechargeable Sicurdrill, made by Human Brain Wave S.r.l. Safety rules and operating procedures must be fully understood before using this device. -
Page 4: Before Use
Before use WARNING • Never use the appliance for purposes other than those intended. Human Brain Wave s.r.l. denies all liability for accidents malfunctions caused improper use. • Read this manual before using the device. In particular, safety warnings and operational procedures must be fully understood. - Page 5 • Before transporting the device to another location, disconnect all cables. If the cables get caught or trampled, the device can fall, causing injury or failure. • Carry out visual and operational checks before using the device. Do not use the device if an error is detected. Using a malfunctioning device does not produce the expected results and can cause problems.
-
Page 6: Table Of Contents
Contents BEFORE USE ............1 1.1. Intended use ..........1 1.2. Packaging content ........1 1.2.1. Accessories ..........1 1.3. Labels and symbols ......... 3 OPERATING PROCEDURE ......... 4 2.1. Overview of operations ......4 2.2. Battery charging ........4 2.3. -
Page 7: Before Use
BEFORE USE 1.1 Intended use The rechargeable Sicurdrill is intended as an electric motor that allows the rotation of the Rigeneracons/Adipecons/kit disposable devices which in turn are devices for the temporary storage and disaggregation of biological samples taken from the patient to obtain autologous micrografts. - Page 8 SICURLID is a sled intended to place the Rigeneracons/Adipecons devices and to permit the connection with the adapter Sicurstick. The HOLDER allows the operator to activate the rotation of the drill without the need to handle it during operation and after the procedure to store it in an orderly manner together with the accessories.
-
Page 9: Labels And Symbols
1.3 Labels and symbols To draw the attention of users, there are labels and instructions affixed to the device. If labels come off, characters fade or become unreadable, contact HBW or your authorized distributor. Manufacturer Manufacturing date Refer to instruction... -
Page 10: Operating Procedure
OPERATING PROCEDURE 2.1. Overview of operations To ensure proper use, follow the steps below: Before each use, charge the battery for at least 15 minutes using the USB cable provided; Press the START button to activate the device and check that the blue LED on the lower part of the display turns on. -
Page 11: Battery Charging
stopped by holding down the START button for 5 seconds 7. At the end of the cycle, separate the components and recover the suspension according to what is reported in the IFU of the Rigeneracons/Adipecons devices 8. Clean the device at the end of the procedure as reported in the appropriate section 2.2 Battery charging... -
Page 12: Maintenance
- E1 = TAG already used - A1= battery charge under 50% - A2= battery charge under 30%. Recharge the device. MAINTENANCE 3.1 Maintenance and cleaning Carry out an overhaul of the rechargeable Sicurdrill every 500 work cycles. No ordinary maintenance by the operators is envisaged No installation is required Check the integrity of the USB-C cable and,... -
Page 13: Standards And Specifications
STANDARDS SPECIFICATIONS 4.1 Applicable rules Electromagnetic Compatibility Directive (EMC) 2014/30/EU (Compliance with the Directive has been reached with reference to EN 60601-1-2 Medical electrical equipment. Part 1: General requirements for safety – Collateral standard: Electromagnetic Compatibility - Requirements and tests. 2015 Regulation (EU) 2017/745 on medical devices... -
Page 14: Product Specification
4.3 Product specification 4.3.1 Operating conditions Rotation time: 1 minute Ambient temperature: + (0 ÷ 40) °C Atmospheric pressure: (70 ÷ 106) kPa 4.3.2 Condition of transport and storage Ambient temperature: (-20 ÷ +60) °C Atmospheric pressure: (70 ÷ 106) kPa... -
Page 15: Disposal Of The Device
DISPOSAL OF THE DEVICE 5.1. Disposal The rechargeable Sicurdrill device must be disposed accordance with regulations in force in the country of use. Caution: For the correct disposal of the rechargeable Sicurdrill device, consider also applicable hospital laws procedures relating to contaminated devices.
Need help?
Do you have a question about the RIGENERA and is the answer not in the manual?
Questions and answers