Nimbus Arm Set Instructions for Use

3 Pages

NV-IFU Rev A Dec-21-2021  Nimbus Arm Set  Quantum OPS, Inc. 4704 Hixson Pike Ste 202 Hixson, TN 37343 Distributed by: NuVasive, Inc. 7475 Lusk Blvd. San Diego, CA 92121 USA +1 800-475-9131 1. Product Handling The Distal Connector, is supplied in a non-sterile condition and must be cleaned and sterilized before each use according to the instructions provided below. The Nimbus Drape is supplied as a sterile kit. All other devices/components are supplied and used non-sterile and should be cleaned before use according to the instructions provided below. Sterile components should always be stored unopened in their respective packs. Prior to use, inspect packaging for damage that may have compromised sterility. Also inspect labeling to verify that expiration date has not passed. If product is damaged or expired, do not use. When removing sterile products from packaging, observe relevant aseptic technique. High temperatures, moisture and humidity can damage Nimbus products. Protect the product against moisture and humidity. Do not store close to radiators and protect from high radiation. Do not expose the product to large impacts and vibration, the product is not designed for impulse loads. 2. Product Description and Materials The Nimbus Arm Set is mounted to the accessory rail of operating tables and it is used to support a variety of instruments relative to patient’s body during orthopedic surgical procedures. The device can be locked in any desired position or orientation using a one-hand operation release trigger at any time. The Nimbus Arm Set includes the following modular components: 1 x Nimbus Arm (6973335) 1 x Bedrail Clamp (6973336) The following is a list of the approved accessories for the Nimbus Arm: • •  Distal Connector (6973337) Nimbus Drape (sterile) (6973339)  Distal Connector (6973337) The Distal Connector (6973337) is used as intermediate element designed to couple the Nimbus Arm (6973337) to a variety of instruments intended for orthopedic surgical procedures. Nimbus Drape (sterile) (6973339) The Nimbus Drape (sterile) (6973339) is used to cover the Nimbus Arm. The kit includes 5 sleeves (nimbus drape). 3. Indications The Nimbus products and all related components and attachments listed above are indicated for patients undergoing orthopedic surgery. 4. Intended Use The Nimbus Arm Set is used, in combination with specific accessories, to position a variety of instruments relative to patient’s body immediately before, during and after surgical interventions as well as for examination and treatment. 5. Contraindications Contraindications include but are not limited to: Infection local to the operative site, signs of local inflammation, patients who are unwilling to restrict activities or follow medical advice, patients with physical or medical conditions that would prohibit beneficial surgical outcome, use with components of other systems unless otherwise specified. 6. Precautions and Warnings Device functionality may be impaired through improper use and/or positioning of Nimbus products. Service and modification to the devices is to be provided by trained personnel only. These devices should be inspected and proper function verified before each use, ensure that this user manual is readily available to all personnel at all times. -  The maximum load capacity for the Nimbus Arm is 20 lbs. (9 Kg).  -  Improper use and positioning may lead to injury. Follow all instructions for use of the operating table system and Nimbus Products and maintain observation of patient while product is in use.  -  Use only approved accessories with Nimbus products. All accessories must be used in accordance with instructions for use. Accessories made by other providers may be used only with written approval from NuVasive.  -  Risk of burns may occur through contact between the Nimbus products and electrical equipment such as computer components and defibrillators. Contact between the patient and metallic surfaces must be avoided.  -  The product can be repositioned by opening fastening elements. Prior to initially mounting or repositioning the product, hold the movable segments securely so that they do not fall or move suddenly. Also, be aware that moving the product during initial mounting or repositioning can expose personnel, patient, and other equipment to pinching or shearing. Prior to mounting or repositioning the product, be sure that the patient, all other personnel and equipment are clear of the product so pinching or shearing does not occur.  -  Improperly secured products or accessories may result in patient injury. After initial positioning and after every repositioning of the product, check all fastening elements (clamps/handles… etc.) to make sure they are fully closed and secure.  -  Do not continue to use the Nimbus products if the products are worn, defective or damaged in any way. Only use the product in full working condition.  -  The Nimbus product is to be used only with accessories specifically designed for the product and approved by NuVasive.  -  A sterile cover must be used on the Nimbus Arm during surgery to avoid contact with liquids and other substances used in surgery.  -  The product is designed to support only the attached instrument. Do not apply any additional loads by leaning or resting on the product.
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File Name: NuVasive - Nimbus - NV-IFU - Nimbus Arm Set Instructions for Use - 2021-12 - Rev A.pdf

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