Cokiya S10 User Manual

Node-O-Scope System User Manual

Node-O-Scope

TM

User Manual

Cokiya Incorporated

Poway, CA, USA 92064

Phone: [phone]

www.cokiyainc.com

DRAFT 11-18-14

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Node-O-Scope System User Manual

CONTENTS

1. Introduction ............................................................................................................................................. 3

Description .............................................................................................................................................. 3

Intended Use ........................................................................................................................................... 3

Indications for Use ................................................................................................................................... 3

Manufacture and Distribution .................................................................................................................. 3

Standards ................................................................................................................................................. 4

EMC ..................................................................................................................................................... 4

Biocompatibility ................................................................................................................................... 4

Sterilization .......................................................................................................................................... 4

Regulatory............................................................................................................................................ 4

2. System Overview ..................................................................................................................................... 5

User Feedback Unit .................................................................................................................................. 5

Node-O-ScopeTM Probe ............................................................................................................................ 6

3. Precautions .............................................................................................................................................. 6

General .................................................................................................................................................... 6

User Feedback Unit .................................................................................................................................. 7

Probe ....................................................................................................................................................... 7

4. Using the system ...................................................................................................................................... 8

Setting Up the User Feedback Unit ........................................................................................................... 8

Deploying the Probe................................................................................................................................. 9

Using the Controls ...................................................................................................................................10

In Surgery................................................................................................................................................12

After Surgery ...........................................................................................................................................14

5. Specifications ..........................................................................................................................................15

Node-O-ScopeTM S-10 Probe ....................................................................................................................15

User Feedback Unit .................................................................................................................................16

6. Troubleshooting ......................................................................................................................................16

7. Labeling ..................................................................................................................................................17

8. EMC Declaration .....................................................................................................................................17

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8. FCC Information ......................................................................................................................................18

1. INTRODUCTION

Description

The Node-O-ScopeTM system is designed to detect and quantify Technetium-99m
radiotracer in radio-guided localization medical procedures. A numeric display and
audible signal convey the amount of radiation detected, allowing the user to localize
radiolabeled tissue.

The system is battery-powered, wireless, and portable. It consists of the Node-O­ScopeTM S10 Gamma Probe and the Node-O-ScopeTM T10 User Feedback Unit.

Intended Use

For the detection and quantification of gamma radiation from Tc-99m radionuclide
in the body or tissues.

Indications for Use

Use in non-imaging procedures to measure relative amounts of Tc-99m radionuclide
absorbed by a particular organ or body region. For transcutaneous, open surgical,
and laparoscopic use.

Manufacture and Distribution

The system is manufactured by Cokiya Incorporated. Please direct all inquiries
about the Node-O-ScopeTM system to Cokiya Incorporated. The following are
trademarks of Cokiya Incorporated: Node-O-ScopeTM system and Node-O-ScopeTM
when used in context with the above.

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Standards

The Cokiya Node-O-ScopeTM system complies with the following standards:

EMC

 EN 60601-1-2: Medical Electrical Equipment Collateral Standard,

Electromagnetic Compatibility - Requirements and Tests

 FCC Part 15C: Intentional Radiators – FCC ID 2ADNA-S10
 Wireless: Bluetooth 4.0BLE

Biocompatibility

 ISO 10993 (including ETO residuals): Biological evaluation of medical

devices: cytotoxicity, sensitization, irritation; externally communicating
device; <24hrs exposure

Sterilization

 ISO 11135: Validation and routine control of ethylene oxide sterilization
 ISO 11737: Tests of sterility
 ISO 11138: Biological indicators

Regulatory

 FDA Device Classification: Class 1

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2. SYSTEM OVERVIEW

The Node-O-ScopeTM T10 User Feedback Unit is used with the Node-O-ScopeTM S10
Probe. A medical-grade battery charger is provided with the system for recharging.

User Feedback Unit

The User Feedback Unit is comprised of a tablet computer running the Cokiya Node­O-ScopeTM application, a loudspeaker, and an IV pole clamp. It includes a medical­grade Battery Charger for recharging. It communicates bi-directionally with the
Node-O-ScopeTM Probe over a Bluetooth Low Energy (‘BLE’) wireless link.

The User Feedback Unit provides displays, sound feedback, and redundant controls
for operating the probe.

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The rate of gamma photons entering the Probe is displayed on the User Feedback
Unit in digits and with a log-scale rate-meter. This rate is also represented by the
audio feedback coming from the speaker.

The User Feedback Unit controls are accessed on the touch pad of the display or on
the top of the User Feedback Unit. The ON/OFF control is located on the top left of
the User Feedback Unit.

Node-O-ScopeTM Probe

The wireless Node-O-ScopeTM Probe is battery-powered (4.5V). It is completely
sealed and supplied sterile for a single-patient use in a TyvekTM peel-pouch. The
pouch is designed for sterile handoff. The Probe can also be used in the pouch
without breaking the seal prior to setting up the sterile field.

The Probe detects and quantifies gamma rays (‘counts’) from Tc-99m isotope and
communicates this information to the User Feedback Unit over the wireless link for
user feedback. The Probe keypad provides the user with control of:

 activation status,
 detection energy window mode*,
 audio feedback volume,
 count-rate range scaling,
 voiced reporting of instantaneous count rate feedback, and
 voiced reporting of integrated count rate feedback*.

*see ‘Using the Controls’, Section 4.

3. PRECAUTIONS

General

 Federal (USA) law restricts this device to sale and use by, or on the order of,

a physician.

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