Disposable Pulmonary Nodules Localization Needle|Ningbo SensCure Biotechnology Co., Ltd..

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Disposable Pulmonary Nodules Localization Needle

China's first dedicated location of pulmonary nodules has obtained Class II of medical device registration certificates and CE certificates

This needle has a positioning line that is made of flexible material and pushed into the chest cavity when the positioning is completed. As such, the pulling force of the thread body on the anchoring needle is effectively avoided, minimizing the displacement of the anchoring needle. Four hooks on the needle help further stabilize the positioning. The positioning line is made with various color segments, which makes intuitively determining the depth of nodule easy. It is used to mark and indicate the depth in the procedure of wedge excision of lung.

Brief description of the procedure

Puncture the introducer needle under CT guidance

Release the localization anchor

Withdrawal of the pushing device

Retract the introducer needle to the chest wall

Push the localization wire into the thoracic cavity

Intraoperatively pull the localization wire to determine the

position of the localization anchor

[Specification]

Table 1 Specification of Disposable Pulmonary Nodules Localization Needle (Unit: mm)

Model	Length of the Needle Tube	Length of the Localization String	Max. Insertion Depth	Max. Nodule-pleura Distance
SS510-10	100	100	100	90
SS510-10L	100	135	100	100
SS510-12	120	100	120	90
SS510-12L	120	155	120	120
SS510-15	150	100	150	90
SS510-15L	150	185	150	150

[Warnings]

1. This product was expressly manufactured for single use and may not be reused after its initial use. The manufacturer declines any responsibility in the case of product resterilization or reuse. The product is not designed for the essential cleaning and sterilization processes. Sterility of the reprocessed single-use product is therefore not guaranteed. In addition, the quality of the material may be impaired, with safe use no longer be guaranteed. The risk of unintended injuries and infection, particularly cross-infection in patients and medical personnel, increases disproportionately in this case.

2. The localization string and localization hook are meant to be guides only. DO NOT use them as retractors.

3. If the buckle of the introducer needle is dislodged before surgery, the localization hook may not be released in the expected position during the operation.

4. The localization hook can only be released after the introducer needle reaches the edge of the pulmonary nodule, and it is strictly prohibited to release it in advance.

5. The localization hook and localization string should only be retained in the body less than 24h.

6.This device is not intended for use except as indicated in the Intended Use.

7. After use, the product may be a potential biohazard. Handle and dispose of in accordance with acceptable medical practice and applicable local, state, and federal laws and regulations related to product contamination by blood.

[Precautions]

1. The intended users shall be experienced in percutaneous lung puncture and receive product training before operation.

2. To reduce the possibility of unwanted complications (pain, pneumothorax, hook dislocation) the period of time up to resection of the lesion should be minimized.

3. The depth of the pulmonary nodule shall not be more than the maximum insertion depth of the product.

4. The patient shall be instructed to inhale and hold his/her breath while the needle is inserted.

5. If a lobectomy or pneumonectomy is being considered by the surgeon, preoperative localization using this product is not required; therefore, no restriction is placed on the depth of the nodule.

6. Once deployed, the localization hook of this product cannot be retracted and is intended for single use only.

CAUTION:Indications, contraindications, warnings and instructions for use can be found in the product IFU supplied with each device. Information for use only in countries with applicable health authority registrations. Products shown for INFORMATION purposes only and may not be approved or for sale in certain countries. Please check availability with your local sales representative or customer service.