Home > Products > Orthopedics & Regenerative Medicine > Mytocel MSK (Musculoskeletal Special)
- Indications
- Intended Use
- Contraindications, Warnings and Precautions
- Instructions for Use and Storage Conditions
．The Rigeneracons tissue processing device must be operated in a medical setting by professionals familiar with the instructions for use.
．The Rigeneracons tissue processing device is intended for the preparation of autologous micrografts. The device itself has no direct clinical
therapeutic effect.
．Limited tissue disaggregation capability may result in improper device operation; however, no risk is expected to the user or the patient
receiving the micrografts.
．No pretreatment or additional procedures are required before using the device.
．This device is supplied sterile. Do not use if the packaging is damaged. Open the sterile packaging immediately before use.
．Use the device only if the packaging is intact.
．The Rigenera rechargeable drilling and sample processing system must be used with the mounting base and connecting rod accessories to
connect to the Rigeneracons tissue processing device.
The Rigeneracons tissue processing device is intended for the mechanical disaggregation and filtration of biological samples (autologous
cartilage tissue, such as auricular cartilage) to obtain a suspension of autologous micrografts.
cartilage tissue, such as auricular cartilage) to obtain a suspension of autologous micrografts.
The Rigenera rechargeable drilling and sample processing system functions as an electric motor to drive the rotation of disposable devices
, including the Rigeneracons tissue processing kit. These devices are used for the temporary storage and disaggregation of biological samples
obtained from the patient (autologous cartilage tissue, such as auricular cartilage) to obtain autologous micrografts.
Contraindications
．The Rigeneracons tissue processing device is supplied sterile and is intended for single use only. Do not reuse, as this may pose a risk ofinfection.
．There are currently no other known contraindications.
．Any serious incident related to this product should be reported to the manufacturer and to the competent authority in the jurisdiction
where the user and/or patient is located.
Rigeneracons Tissue Processing Device — Warnings and Precautions
．Use only the USB cable supplied by the manufacturer. Do not use the supplied USB cable with other equipment, as this may cause a
malfunction.
．Always turn off the device before connecting any cables. Failure to do so may cause a malfunction.
．Do not the USB cable into any port other than a USB port, as this may cause a malfunction.
．Disconnect all cables before moving the device. If a cable is pulled or stepped on, the device may fall, resulting in injury or malfunction.
．Perform a visual inspection and an operational check before use. Do not use the device if any abnormalities are detected. Using a
malfunctioning device may lead to unexpected results and other problems.
．Always use accessories or devices specified by the manufacturer. Using accessories or devices not specified by the manufacturer may cause a
malfunction or an adverse event.
During Operation
．Battery does not charge: Check that the USB cable is properly connected.
．Screen does not turn on: Check that the start button has been pressed or that the tag on the disposable tissue holder packaging has been
scanned using the RFID reader located on the back of the Rigenera rechargeable drilling and sample processing system.
．The screen may display the following error codes:
E1 = The tag has already been used.
A1 = The battery level is below 50%.
A2 = The battery level is below 30%. Only one use remains. Please recharge the device.
Instructions for Use
1. Place the sample on the grid and add 4 mL of sterile saline solution, ensuring that the liquid wets the grid.2. Place the Rigeneracons tissue processing device in the mounting base and connect it to the Rigenera rechargeable drilling and sample
3. processing system using the connecting rod.
4. Activate the Rigenera rechargeable drilling and sample processing system to perform 3 or 6 disaggregation cycles, each lasting 1 minute. The
Rigeneracons tissue processing device may be operated for a maximum of 10 cycles.
5. Collect the micrografts through the designated port using a syringe without a needle.
Storage Conditions
Store in a dry place away from heat sources.
