Use Instructions

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DRAFT – PROPRIETARY AND CONFIDENTIAL

AMS 511- Rev A A.M. Surgical Pegasus Wireless Endoscopic Camera System IFU Page 2 of X

1. Introduction

Intended Use

Pegasus is intended to be used in an operating room during endoscopic and

arthroscopic procedures.

Indications for Use

Pegasus is indicated for use in diagnostic and operative endoscopic and arthroscopic

procedures to provide illumination and visualization of an interior cavity of the body through

either a natural or surgical opening.

Device Description

The AM Surgical Pegasus Wireless Endoscopy System is a sterile, disposable,

endoscopic device that consists of a wireless camera and receiver. The endoscopy unit

incorporates a transmitter that delivers an uncompressed analog video signal to a receiver

module. The receiver module is connected to a video display using a standard TV composite

cable. An integrated LED light source eliminates the need for a separate light source and light

cable, and the camera is powered by battery.

The Pegasus device includes the endoscopy unit with the LED light source and camera

embedded in the shaft, a wireless receiver, a composite video cable, and power cords. Refer to

Figure 1 on the following page.

Contraindications

None known.

Warnings

 Do not dispose of camera device without first powering it off to avoid interference.

 Do not attempt to modify or disassemble the Pegasus camera device, receiver, or

any other component. Doing so may damage the device or create a safety hazard.

 Do not use if handling causes device to become non-sterile or if packaging has

been damaged.

INSTRUCTIONS FOR USE

Wireless Endoscopy System

Read all instructions prior to use

Caution: Federal (US) Law Restricts this device to sale by or on the order of a physician.

Summary of content (8 pages)

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DRAFT – PROPRIETARY AND CONFIDENTIAL INSTRUCTIONS FOR USE Wireless Endoscopy System Read all instructions prior to use Caution: Federal (US) Law Restricts this device to sale by or on the order of a physician. 1. Introduction Intended Use Pegasus is intended to be used in an operating room during endoscopic and arthroscopic procedures.
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DRAFT – PROPRIETARY AND CONFIDENTIAL Figure 1 - A.M. Surgical Pegasus Wireless Endoscopy System (Catalog Number XXX-XXX) Precautions  Do not reuse the Pegasus unit. One-time use only. Receiver may be reused after disinfection.  Do not submerge or allow liquids to enter the body of the Pegasus, as it is only water resistant and this may damage the electronics within the device.  Use only the supplied cables and components with the Pegasus Camera System.
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DRAFT – PROPRIETARY AND CONFIDENTIAL 2. Instructions for Use Preparation & Installation of Receiver 1. Place the receiver in an area such that it is no more than 15 feet away from the endoscopy unit for the duration of the procedure. Ensure wires are clear of any walking path to minimize risk of tripping. 2. Connect the composite cable from the output of the receiver module to the composite input on the video monitor. 3. Connect the barrel connector of the AC power supply to the 5V input on the receiver.
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DRAFT – PROPRIETARY AND CONFIDENTIAL 5. Maintenance of Quality of Service & Security 6.
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DRAFT – PROPRIETARY AND CONFIDENTIAL Technical Specifications & Compliance Item Depth of Field Field of View Direction of View Wireless Signal Type Frequency Band Image Latency Weight (Unit) Camera Native Resolution Supported Video Video Output Expected Service Life Battery Type Mode of Operation Battery Life at Full LED Power Safe operating ambient temperature range Safe storage and transport temperature range Safe operating, storage, & transport relative humidity range Complies with industrial electrical
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DRAFT – PROPRIETARY AND CONFIDENTIAL 7. FCC Warnings Changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment. This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: 1. This device may not cause harmful interference, and 2. This device must accept any interference received, including interference that may cause undesired operation.
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DRAFT – PROPRIETARY AND CONFIDENTIAL 7. Warranty & Repair Service Limited Warranty A.M. Surgical Inc. warrants for a period of one (1) year following purchase of the product that the product will be free from defects in material and workmanship. Within the warranty period, upon receipt of Customer’s prior written notice, A.M. Surgical may either repair or replace defective parts/products at no charge to Customer. A.M. Surgical Inc.
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DRAFT – PROPRIETARY AND CONFIDENTIAL 8.