Intuitive DAVINCI XP - General Warnings and Cautions; General Instructions for Use

General Information
da Vinci SP Instruments and Accessories
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DRAFT/PRE-RELEASE/CONFIDENTIAL 12/5/19
1.5 General Warnings and Cautions
WARNING: When instruments (camera and surgical) are not in use, they need to be
placed in a clean, dry, highly visible area not in contact with the patient. Inadvertent
contact with the patient may result in burns.
WARNING: Do not use instruments, cameras, or accessories that have been
reprocessed with single-use accessories installed. Inadequate sterilization may
occur when these single-use accessories, such as the MCS Tip, monopolar cautery
tip, sheath, SP Cannula Seal, or EntryGuide™ (also known as Entry Guide), are
installed during reprocessing.
CAUTION: Use only the instruments and accessories approved by Intuitive Surgical.
System compatibility with non-approved instrumentation cannot be guaranteed.
CAUTION: EndoWrist SP instruments and accessories should be handled and
operated by trained personnel.
Cautions for Single-Use Items
CAUTION: DO NOT RE-STERILIZE. DO NOT RE-USE.
Reprocessing and/or reuse of products intended for single use only may result in
degraded instrument performance or loss of functionality, and in exposure to viral,
bacterial, fungal, or prionic pathogens.
CAUTION: Do not use if package is damaged.
CAUTION: A breach in the sterile packaging of the device indicates possible
contamination. Do not use the device if the packaging is not intact.
1.6 General Instructions
Proper Care and Handling
Proper care and handling is essential for satisfactory performance of surgical instruments and
accessories. Use care when handling devices during setup and operation. Examine the
instrument or accessory, including all of its components, thoroughly before and after each
use. If any abnormality is found (such as dents), do not use the instrument or accessory. Use
the device for its intended purpose only.
Do not expose instruments to X-rays, radioactive rays or strong electromagnetic waves.
Otherwise, the instrument may be damaged, making it unrecognizable to the system.
Storage Between Uses
After removing products from their packaging, store Intuitive Surgical instruments,
accessories or components in a clean, dry, dark place. Care must be taken to protect the
instrument tips from damage.