LionsGate Technologies Kenek O2 User manual

Kenek O2 Pulse Oximeter System
LionsGate Technologies, Inc.
Kenek O2 Pulse Oximeter System
User Manual!

Introduction 5.............................................................................................................
Kenek O2 5...........................................................................................................................
Intended Use 6.....................................................................................................................
Contraindications 7...............................................................................................................
Symbols 8...................................................................................................................
System Components 12............................................................................................
Compatibility 14....................................................................................................................
Safety Information and Warnings 15........................................................................
Definitions 22.............................................................................................................
Smart Circles 22...................................................................................................................
Getting Started 27......................................................................................................
Download the Kenek O2 App 27...........................................................................................
Try it Out 28..........................................................................................................................
Activate Sensor 29...............................................................................................................
The Sensor 31......................................................................................................................
General Use 34...........................................................................................................
Welcome Screen 34..............................................................................................................
Oximeter Screen 35..............................................................................................................

Graph 36...............................................................................................................................
Pleth Waveform 37...............................................................................................................
Menu 39................................................................................................................................
Data Recording 41................................................................................................................
Duration 42...........................................................................................................................
Profile 43...............................................................................................................................
Export Data 48......................................................................................................................
Specifications 51........................................................................................................
SpO2 Accuracy 53................................................................................................................
Pulse Rate Accuracy 54.......................................................................................................
LED Characteristics 54.........................................................................................................
Temperature Test 55.............................................................................................................
Materials 55..........................................................................................................................
Classifications per IEC 60601-1 / CAN/CSA-C22.2 601.1 56...............................................
Electromagnetic Compatibility 57.........................................................................................
Maintenance 62..........................................................................................................
Cleaning and Storage 62......................................................................................................
How to Clean the Sensor 63.................................................................................................
Storage and Transport 64.....................................................................................................

Support 65..................................................................................................................
Usage Guidelines 66............................................................................................................
Functional Testing of the Kenek O2 Pulse Oximeter 68.......................................................
Testing with the Fluke SPOTLight simulator 70....................................................................
Sales and End-User License Agreement 72............................................................
Warranty and Service Life 73................................................................................................
Restrictions 74.....................................................................................................................
User Restrictions 75.............................................................................................................
Transfer Restrictions 76........................................................................................................

Kenek O2 Pulse Oximeter System 5
LionsGate Technologies, Inc.
INTRODUCTION
Pulse oximetry is a non-invasive method of measuring the level of oxygen in a
person’s hemoglobin, the part of blood that carries oxygen through the body and
gives blood its red color. This measurement is known as blood oxygen saturation,
or SpO2.
Kenek O2
The Kenek O2 pulse oximeter is an easy-to-use system for sampling, or spot-
checking, a person’s SpO2and heart rate. It consists of the portable finger clip
sensor and the Kenek O2 app. The finger clip sensor connects to the audio port
of any compatible Apple iPod, iPhone or iPad. It is powered by the Apple device,
so it does not require batteries. (For the complete list of supported Apple
devices, see the Compatibility section.) The Kenek O2 app must be
downloaded from the Apple App Store.!

Kenek O2 Pulse Oximeter System 6
Introduction
Intended Use
The Kenek O2 pulse oximeter is indicated for use in a home health care
environment to spot-check adults age 21 years and over who are under the care
of a physician. It may also be used by a physician or qualified clinician in a
professional healthcare office or clinic for spot-check purposes. The portable
finger clip sensor is intended for patients with fingers 0.8 cm to 2.0 cm in
diameter.!

Kenek O2 Pulse Oximeter System 7
Introduction
Contraindications
The Kenek O2 pulse oximeter is not intended for:
•long-term, continuous monitoring of patients such as in acute or critical
care.
•professional healthcare patient transport such as in ambulances.
•magnetic resonance environments.
The Kenek O2 pulse oximeter does not have physiological alarms.!

Kenek O2 Pulse Oximeter System 8
LionsGate Technologies, Inc.
SYMBOLS
Follow Instructions for Use
Indicates separate collection for electrical and electronic equipment
(WEEE).
Non Sterile
No SpO2 alarms.!

Kenek O2 Pulse Oximeter System 9
Symbols
CE Marking: conformance to EC Directive No. 93/42/EEC for
medical devices
Avoid exposure to sunlight
Keep Dry
Type BF-Applied Part (Patient isolation from electrical shock)
Operating temperature range 5 °C to 35 °C

Kenek O2 Pulse Oximeter System 10
Symbols
Protected from touch by fingers and objects greater than 12 mm.
Protected from water spray less than 15 degrees from vertical.
Serial Number
Lot Number
Model Numbers

Kenek O2 Pulse Oximeter System 11
Symbols
Manufacturer
Date of Manufacture

Kenek O2 Pulse Oximeter System 12
LionsGate Technologies, Inc.
SYSTEM COMPONENTS
The Kenek O2 pulse oximeter system includes:
•Finger Clip Sensor with cable to connect to the audio port on the Apple
device
•Kenek O2 app downloaded from the Apple App Store
•Quick Start Guide and included Activation Code

Kenek O2 Pulse Oximeter System 13
System Components
Kenek O2
Finger Clip Sensor
Kenek O2
Quick Start Guide
Kenek O2
Activation Code

Kenek O2 Pulse Oximeter System 14
System Components
Compatibility
The Kenek O2 pulse oximeter is compatible with the following Apple operating
systems (iOS) and devices:
•iOS version 7, 8
•iPod Touch 5
•iPhone 5, 5C, 5S, 6, 6 plus
•iPad 2, 3, 4, Air, Air 2, Mini, Mini 2, Mini 3

Kenek O2 Pulse Oximeter System 15
LionsGate Technologies, Inc.
SAFETY INFORMATION AND WARNINGS
This manual, including all precautionary information and specifications, should be
read before use.
Always use the Kenek O2 pulse oximeter in accordance with the directions in
this manual.
Warning: The Kenek O2 pulse oximeter does not have
physiological alarms.
Warning: Consult your physician for normal ranges for SpO2and
heart rate for a patient with your history and characteristics.
!
!

Kenek O2 Pulse Oximeter System 16
Safety Information and Warnings
Warning: Do not connect the portable finger sensor to any device
not listed in the Compatibility section.
Warning: When using the Kenek O2 pulse oximeter, do not
connect anything other than a Kenek O2 finger clip sensor into
any connector of the Apple device, including the audio port and
docking port. It is unsafe to connect or use any accessories,
detachable parts or materials not described in this manual.
Warning: The finger clip sensor is not defibrillator proof.
Warning: Not for use on children. This product is not a toy.
!
!
!
!

Kenek O2 Pulse Oximeter System 17
Safety Information and Warnings
Warning: Do not connect the Apple device to any power source,
wall charger, laptop or computer when using the Kenek O2 pulse
oximeter.
Warning: Do not modify, repair, open, disassemble or submerge
in any form of liquid. Injury or equipment damage could occur.
Warning: The finger clip is designed for fingers that are 0.8 cm to
2.0 cm in diameter. Smaller fingers will not fit the sensor correctly,
which may impact the accuracy of the measurement. !
!
!
!

Kenek O2 Pulse Oximeter System 18
Safety Information and Warnings
Warning: Do not run or switch to other apps on your Apple device
while recording test data.
Warning: Use the Apple device in accordance with the safety
information provided with the device. Improper use of the Apple
device may result in injury or damage to the device. Do not use
any charger other than the one provided with the Apple product.
Warning: Do not apply excessive or prolonged pressure to the
sensor. This can lead to possible pressure injury. Not intended for
continuous use. Do not use continuously for more than 60
minutes.!
!
!
!

Kenek O2 Pulse Oximeter System 19
Safety Information and Warnings
Warning: The sensor should not be used in high-humidity or high-
pressure environments (do not exceed 15% to 93% non-
condensing and 700 hPa/mbar to 1,060 hPa/mbar).
Warning: The sensor should be kept away from areas where lint
and/or dust are present. Keep the sensor away from pets and
children.
Warning: A functional test cannot be used to access the
accuracy of the sensor.
Warning: Do not use in oxygen-rich environments or in the
presence of flammable anesthetics.
!
!
!
!

Kenek O2 Pulse Oximeter System 20
Safety Information and Warnings
Warning: Avoid direct sunlight as it can affect the accuracy of the
measurements.
Warning: Do not use the Kenek O2 app if the Apple device has
less than 5% battery capacity remaining.
Warning: Use only with Kenek O2 sensors. Do not use sensors
from other devices or models.
Warning: Do not use a Kenek O2 sensor that has exposed
electrical components. Do not use a damaged sensor.
!
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