INSTRUCTIONS FOR USE
SPIROTOME FLEX
BIOPSY NEEDLE SET
12 - 19 G
Product trade name
Variant / Configuration
Article number / REF Basic UDI DI 5407005000007
UDI per variant
Spirotome Flex/19G1050mm SS-19-FL 5407005001295
Spirotome Flex/16G1000mm SS-16-FL 5407005001301
Package Content
Device description
DEVICE DESCRIPTION: The Spirotome Flex Biopsy Needle Set contains
· A two-part catheter that consists of a cutting catheter and receiving catheter
· An internal wire (optional)
· A release element
Who should use?
Only to be used by a qualified, experienced, and trained physician after all necessary clinical precautions for a safe procedure have been taken.
Intended use
The Spirotome Biopsy Needle Set is a family of core soft tissue biopsy medical devices to be used in humans to take out adequate samples of soft tissue from subdermal structures as breast, abdominal wall, thoracic wall, lymph nodes, thyroid, parotis, muscles, liver, human uterus, cervix, retroperitoneal lymph nodes. The Spirotome Flex is to be used in endoscopic procedures.
How supplied?
The different gauges and lengths of the Spirotome Flex are supplied in steam sterilized in peel-open pouch. Hub colors reflect only marketing purposes.
Risk mitigation measures and residential risk/side effects(conveyable to the patient)
· Patients with increased bleeding times or elevated INR may have a higher risk of bleeding at the biopsy site
· In case of expanded helix by forced rotation, the system will not work optimal. Don’t pull or use the cutting catheter, but turn the receiving catheter counterclockwise until the Spirotome is outside the patient
· Do not use the product if there is doubt as to whether the product is sterile or if package is damaged.
· In case of bad condition of the patient, rescue conditions should be foreseen.
· Apply proper anesthesia and disinfection while performing a biopsy. Pain might appear when local anesthesia is not appropriate
· Anticoagulant medication should be stopped or evaluated by the interventionist prior to the biopsy step
· Specific risk mitigation measures may be necessary for special indications such a pneumothorax prevention and when postprocedural compression is not possible.
· In certain conditions, the harvested sample should remain sterile for further use
Precautions
Use of imaging technology (radiology, CT, ultrasound, or MR) is recommended when using this product. The catheter fits certain endoscopic devices
Contraindications
Anticoagulant medication
Warnings
· Rx Only: U.S. federal law restricts this device to sale by or on the order of a physician (or properly licensed practitioner)
· Only for soft tissues
References
These instructions for use are based on risk assessment and experience from physicians, and (or) their published literature. Refer to your local sales representative for information on available literature or consult the website: www.bioncise.com
Spirotome Flex procedure for use with endoscopes
The Spirotome Flex is taken from the pouch together with the release element and put on a sterile drape. The catheter has at its proximal end a spacer for safe entrance in the working channel. The patient should have proper preparation according to institutional protocol. The cutting catheter is the outer one and is in contact with the working channel. The inner receiving catheter is has 2 marks on its most proximal part to indicate the position of the tip of the helix relative to the edge of the cutting catheter. The internal wire or any ablative tool is optional and fits in the internal channel of the cutting and/or receiving catheter.
When the target is visible, the helix is turned clockwise into the lesion up to 1 cm (length of the helix). The distal mark on the receiving catheter is not longer visible when the helix is entirely in the target. A vacuum can be applied to the helix during the biopsy step and during retraction of the receiving catheter by putting an aspiration syringe at its proximal end.
The cutting catheter is now advanced in a clockwise manner under constant light pressure. The sample is cut from the surrounding organ. The 2 markers on the receiving catheter are now visible again to indicate that the helix is inside the cutting catheter. After complete cutting, both cutting and receiving catheters are withdrawn together to avoid sample loss. Additionally, vacuum can be applied to secure the sample in the helix during retraction.
To release the sample from the helix, the teeth of the release element are placed over the helix and turned in anticlockwise over the helix to free the tissue. To evacuate remaining sample on the teeth and to clean the release element, a syringe with fixator or physiological solution is placed on the luer end and fluid is injected into the release element.
Label
Consult instructions for use
Steam Sterilized
Not made with natural rubber latex
Use by date
Do not reuse !
Reusing the device can affect sterility and the safety of the patient
Do not use if package is damaged ! Using the device from a damaged package can affect sterility and safety of the patient
Fragile – Handle with care
Manufacturing date
Do not resterilize !
Resterilizing the device can affect sterility and safety of the patient
After use, the product can be a potential biohazard ! Discard the device in an appropriate container for sharp and contaminated medical devices.
MRI conditional
Up to 3 Tesla
Long term storage condition: keep dry (30-60 %RH) and between 7 and 29°C (45 to 85 °F)
