01-0043RS

Product image of the Situate™ detection system X

Indications, Safety, and WarningsThe Situate™ detection system X uses a low-energy radiofrequency (RF) signal to detect surgical premium cotton (gauze, sponges, and towels) left in or around the patient within the surgical field. Situate™ scanning devices emit an electrical impulse that, when passed over an RF-tagged item, resonate a signal back to the scanner.Indications for use

The Situate™ delivery system is indicated to detect tagged objects, such as surgical gauze, towels, and sponges during a surgical procedure in order to aid surgical staff in the recovery of those objects before closing. The system is intended for use by trained surgical staff in a surgical setting.

The system is indicated for use as an adjunctive device to complement, not replace, established safety procedures to prevent retained objects.

Warnings

Do not connect wet instruments to the console. Ensure that all instruments are correctly connected and that no metal is exposed at any connection points.

Do not use extension cords — fire hazard.

Read the instructions for use, warnings, and cautions provided with Situate™ delivery system before using.

To avoid risk of electrical shock, connect the power cord to a properly grounded power receptacle. Position the console so it does not block access to power switch or power plug connection.

Electromagnetic interference caused by MRI, power transformers, or other high-power sources may affect the system’s ability to detect tagged objects.

Unfolding gauze sponges can expose woven edges and the radiopaque marker to damage and may release cotton fibers.

Do not cut any Situate™ premium cotton products (for example, vaginal packaging). Cutting may damage the pouch and separate the RF-detectable tag from the product.

Scanner drapes and surgical cotton disposables are packaged sterile. Sterility is maintained unless the package or seal has been opened.

Follow the hospital procedure for draping non-sterile devices. Cover all portions of the scanner and cord to avoid contamination and cross-contamination during the procedure.

Risk of explosion if used in the presence of flammable anesthetics.

Do not move the room scanner at a rate faster than 15.2 cm (6 in) per second. Exceeding this rate may diminish the system’s ability to detect tagged objects.

Never touch a console interface connection (USB or LAN) and the patient at the same time.

Use the device with caution when operating near external or implanted electronic medical devices. Electromagnetic interference produced by the operation of the Situate™ detection system can potentially cause a device to temporarily operate in an unsafe mode. Consult the manufacturer of the external or implanted electronic device or responsible hospital department for further information when use is planned in close proximity to such medical devices.

Refer to the pacing or defibrillator device manufacturer’s instructions, hospital protocol, and the full instructions for use to ensure optimal operation of these devices. Scanning may affect temporary cardiac pacer in the demand mode settings (DDD). Temporary cardiac pacers should be in non-sensing, asynchronous mode (VOO or DOO) during scanning.

Do not program pacing or ICD devices while scanning. Visual and audible indicators are present while scanning is active. Follow the pacing or defibrillator device manufacturer’s instructions to achieve desired programming settings.

Note: Independent laboratory testing and extensive hospital clinical experience demonstrate that the Situate™ detection system can be compatible with most commonly used pacing and defibrillator devices when used in accordance with the manufacturer directions and hospital protocol.

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