StimuQuik® Echo Insulated Peripheral Nerve Block Needle

StimuQuik® Echo Insulated Peripheral Nerve Block Needle Rx only. Device Description:

A Suggested Procedure: Use sterile technique.

The Arrow® StimuQuik® Echo Insulated Peripheral Nerve Block Needle is used for single-shot nerve block anesthesia or analgesia techniques.

1. Position patient to provide optimum access to intended needle insertion site. 2. Prep puncture site and drape to form sterile field. 3. Connect StimuQuik Echo needle extension cable to mated electrical cable of nerve stimulator. Check to make sure that connection is secure. Connect nerve stimulator’s grounding clip to an ECG electrode pad, affixed to patient’s skin. 4. Raise local anesthetic skin wheal at site of intended StimuQuik Echo needle puncture. 5. Set nerve stimulator to 1 - 2 mA. Advance needle until appropriate muscle twitches are encountered. These are, for example, biceps, deltoid and/or tricep muscles in cases of interscalene approach to brachial plexus; muscles around the wrist and elbow in cases of more distal brachial plexus blocks; quadricep muscles in cases of psoas compartment lumbar plexus blocks and ankle/foot muscles in cases of sciatic nerve block. Precaution: Inappropriate muscle twitching, for example rhomboid muscle twitching during interscalene approach, indicates dorsal scapular nerve stimulation and will result in a failed block. 6. Start with a nerve stimulator output of approximately 1 - 2 mA and decrease output as needle tip moves closer to nerve. Turn output of nerve stimulator down to lowest output that initiates muscle twitching (usually below 0.5 mA). Warning: The lower the current with resulting stimulation, the higher the risk of intraneural needle placement. Warning: Intraneural injection may cause nerve damage. 7. Inject a test dose of local anesthetic agent through the needle. Warning: Aspirate syringe prior to making any injection through needle. If blood is returned in plunger barrel, needle has been placed intra-vascularly. Remove needle and attempt a new placement. If any doubt exists about intra-vascular needle placement, inject 3 ml of lidocaine with 1:200,000 epinephrine through needle and carefully observe heart rate. A heart rate increase suggests intravascular injection and needle should be removed. 8. Incrementally inject remaining local anesthetic solution, aspirating frequently. Remove stimulating needle. 9. After completion of procedure, dispose of all components properly.

Indications for Use: The Arrow StimuQuik Echo Insulated Peripheral Nerve Block Needle permits the stimulation and location of nerves and nerve plexuses for single-shot nerve block anesthesia or analgesia techniques.

Contraindications: Pre-existing nerve injury, neuritis or plexitis are relative contraindications for use of peripheral nerve blocks. These conditions should be considered prior to needle insertion. Skin sepsis in the area where the needle placement is planned and systemic sepsis are relative contraindications. Extreme care should be taken in patients with bleeding tendencies or patients receiving anticoagulants.

Clinical Benefits to be Expected: 1. Regional anesthesia to permit surgery to (for example) upper limb 2. Regional analgesia for post-operative pain relief following surgery to (for example) upper limb 3. Regional analgesia to reduce incidence of phantom limb phenomena following amputation

General Warnings and Precautions Warnings: 1. Sterile, Single use: Do not reuse, reprocess or resterilize. Reuse of device creates a potential risk of serious injury and/or infection which may lead to death. Reprocessing of medical devices intended for single use only may result in degraded performance or a loss of functionality. 2. Read all package insert warnings, precautions and instructions prior to use. Failure to do so may result in severe patient injury or death. 3. Due to the risk of exposure to HIV (Human Immunodeficiency Virus) or other blood borne pathogens, health care workers should routinely use universal blood and body-fluid precautions in the care of all patients. 4. The Arrow StimuQuik Echo Insulated Peripheral Nerve Block Needle is not intended for use as a spinal or epidural needle. 5. Do not use needle for electrical ablation procedures. 6. Clinicians must be aware of complications/undesirable sideeffects associated with peripheral nerve blocks including, but not limited to:

• catheter shearing • catheter knotting • nerve/tissue trauma • infection risk • nerve block failure

For reference literature concerning patient assessment, clinician education, insertion technique, and potential complications associated with this procedure, consult standard textbooks, medical literature, and Arrow International LLC website: www.teleflex.com

• hematoma • pneumothorax • local anesthetic

toxicity due to intravenous injection

A pdf copy of this IFU is located at www.teleflex.com/IFU For a patient/user/third party in the European Union and in countries with identical regulatory regime (Regulation 2017/745/EU on Medical Devices); if, during the use of this device or as a result of its use, a serious incident has occurred, please report it to the manufacturer and/or its authorized representative and to your national authority. The contacts of national competent authorities (Vigilance Contact Points) and further information can be found on the following European Commission website: https:// ec.europa.eu/growth/sectors/medical-devices/contacts_en

Precautions:

1. Procedure must be performed by trained personnel well versed in anatomical landmarks, safe technique and potential complications. 2. Use standard precautions and follow institutional policies for all procedures including safe disposal of devices. 1