True wearables Oxxiom User manual

true wearables

oxxiom

Wireless, Disposable, Single-Use

Pulse Oximetry System

Made in USA

User Guide

Requires Oxxiom Rx App

for iOS devices

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Read this entire guide carefully before using the

Oxxiom Pulse Oximetry System.

At the time of publication, this guide is believed to be

accurate and up-to-date. In the interest of continued

product development, True Wearables, Inc. reserves the

right to make changes and improvements to this guide

and the products described herein at any time, without

notice or obligation.

True Wearables, Oxxiom, and the True Wearables logo

are registered trademarks of True Wearables, Inc. The

other trademarks mentioned in this guide are registered

trademarks of the respective owners.

True Wearables, Inc.

29826 Avenida de Las Banderas, Suite 300

Rancho Santa Margarita CA 92688

Tel: (949) 709-0850

Failure to follow instructions and warnings may

result in serious injury or death.

Caution: Federal law restricts this device to sale by

or on the order of a healthcare professional.

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TABLE OF CONTENTS

INTENDED USE AND INDICATIONS FOR USE……………………………………

CONTRAINDICATIONS………………………………………………………………..

WARNINGS………………………………………………………………………………

PRECAUTIONS………………………………………………………………………….

DEVICE DESCRIPTION………………………………………………………………..

PACKAGE LAYOUT AND CONTENTS………………………………………………

USING THE OXXIOM PULSE OXIMETRY SYSTEM………………………………

SYMBOLS IN THE OXXIOM RX APP……………………………………….………

GUIDED ACCESS MODE……………………………………………………………..

OXXIOM WARNING SYSTEM………………………………………………………..

MORE INFORMATION ON OXXIOM RX APP………………………………………

CARE AND MAINTENANCE………………………………………………………….

TROUBLESHOOTING…………………………………………………………………

DEVICE PERFORMANCE……………………………………………………….…….

OXXIOM DEVICE TECHNICAL SPECIFICATIONS………………………………..

OXXIOM RX APP TECHNICAL SPECIFICATIONS………………………………..

FCC DECLARATION…………………………………………………………………..

PRIVACY – IMPORTANT INFORMATION…………………………………………..

CONTACT INFORMATION FOR SERVICE, SUPPORT AND WARRANTY….…

SYMBOLS GLOSSARY…………………………………….………………………..…

102

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INTENDED USE AND INDICATIONS FOR USE

The Oxxiom Pulse Oximetry System is a wireless, fully

disposable, single-use device indicated for measuring,

displaying, and storing functional oxygen saturation of

arterial hemoglobin (SpO2) and pulse rate (PR). It may

be used for spot checking, intermittent monitoring, and/or

data collection of patients 12 years and older in low acuity

settings in facilities such as hospitals, clinics, and doctor’s

ofﬁces. It can also be used in home healthcare settings

under prescription use. It is not intended for continuous

monitoring.

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CONTRAINDICATIONS

1.The Oxxiom Pulse Oximetry System is MR Unsafe.

Keep it outside of the MRI scanner room.

2.Explosion Hazard: Do not use Oxxiom in an explosive

atmosphere.

3.Do not use Oxxiom in the presence of ﬂammable

anesthetics or gases.

4.Oxxiom is intended for single-use only. Do not gas

sterilize or autoclave Oxxiom. Do not expose or

immerse Oxxiom in any liquids. Do not use caustic or

abrasive cleaning agents on the device.

5.Oxxiom is not deﬁbrillation proof.

6.Oxxiom is not for use in situations which require

continuous monitoring and alarming of SpO2 values.

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1.The device is not intended for critical care monitoring or

situations when saturations less than 85% are

anticipated.

2.Oxxiom is not intended for use as a diagnostic tool. It

is an adjunctive device that must be used in conjunction

with other methods of assessing clinical signs and

symptoms.

3.Do not modify Oxxiom in any way. Maintenance is not

required.

4.The operation of this device may be affected when near

an electrosurgical unit.

5.The wireless path must be unobstructed. The iOS host

device must be within 10 meters (33 feet) of the

Oxxiom device. Oxxiom is not intended for use in

remote monitoring.

6.Exposure of Oxxiom’s optical detector to direct sunlight

or strong ambient light will cause malfunction.

WARNINGS

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7.Oxxiom is a single-use disposable device that uses a

non-rechargeable LiMnO2 battery. Do not attempt to

remove or recharge the battery or disassemble/repair

the device in any way. Do not expose the battery to

heat or open ﬂames.

8.Dispose of Oxxiom properly. Batteries can leak or

explode if used or disposed of improperly. Follow local

ordinances for disposal.

9.Battery life may be signiﬁcantly shortened by being in

stand-by mode for an extended amount of time.

10.Oxxiom is a wireless device. Other equipment may

interfere with this device, even if they comply with

CISPR emission requirements. The wireless

connection between the Oxxiom device and the iOS

device may be affected by other Bluetooth audio

equipment also connected to the same iOS device.

WARNINGS, CONT.

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1.This device has been tested and found to comply with

IEC 60601-1-2 for Electromagnetic Compatibility (EMC)

for medical electrical equipment and/or systems. This

standard is designed to provide reasonable protection

against harmful interference in healthcare settings.

Because of the increased number of radiofrequency

transmitting equipment and other interference sources

in the environment of operation, high interference levels

might occur and disrupt the operation of this device.

2.If Oxxiom appears damaged or if Oxxiom fails to

respond as described, discontinue use immediately and

replace the device.

3.Minimize motion of measurement site. Oxxiom may

misinterpret motion as good pulse quality.

4.Oxxiom’s principle of operation is based on the

reﬂectance of red and infrared light. Intravascular dyes,

dyshemoglobinemia (dysfunctional hemoglobin), and

ﬁnger deformities and calluses may affect SpO2

accuracy or make readings unreliable.

PRECAUTIONS

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5.Do not shower, bathe, or swim with Oxxiom. The

device is not waterproof and may malfunction if

immersed in water or exposed to high levels of heat or

humidity.

6.Oxxiom may not work on cold extremities due to

reduced circulation. Warm or rub the extremity to

increase circulation.

7.Finger deformities and calluses may cause inaccurate

readings.

8.Inspect the measurement site at least every 8 hours to

ensure correct device placement, following these steps:

(a)Remove self-adhering breathable gentle tape from

the patient’s ﬁnger.

(b)Inspect Oxxiom device to make sure it is placed

correctly on the ﬁngertip. Adjust if necessary.

(c)Wrap (same or new) breathable gentle tape around

Oxxiom and ﬁngertip. Aim for a comfortable, snug

ﬁt.

PRECAUTIONS, CONT.

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9.Excessive pressure to the measurement site may

damage tissue or make measurements inaccurate.

10.Some patients’ skin may be sensitive to the Oxxiom

tape and/or adhesive.

PRECAUTIONS, CONT.

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DEVICE DESCRIPTION

Oxxiom Pulse Oximetry System is a wireless, fully

disposable, single patient use device for measuring and

displaying functional oxygen saturation of arterial

hemoglobin (SpO2), pulse rate (PR) and pulse amplitude

(PA).

Oxxiom has two main components, the Oxxiom device

(hardware device) and the Oxxiom Rx App. Oxxiom does

not have a dedicated display or alarm system. It requires

a handheld iOS device for use. The iOS device can be an

iPhone, iPad, or iPod device with iOS version 10.1 or

later.

Oxxiom is small, lightweight, and has a maximum

duration of 24 hours of use. The device simultaneously

and wirelessly transfers all collected data to the Oxxiom

Rx App on the iOS device, which analyzes data, displays

information, provides warnings as necessary, and stores

the information.

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DEVICE DESCRIPTION, CONT.

The Principle of Operation is based upon the reﬂectance

of light.

Epidermis

Dermis

Oxxiom

Red and Infrared

lights are

applied to the

measurement site

by the light emitter

The red and infrared light rays penetrate the

blood perfused dermis and interact with the

heart’s pulsatile signal in order to create red and

infrared optical pulsatile signals

The optical pulsatile signals

(photoplethysmographs) are

captured by the light detector,

ﬁltered, and conditioned to

produce readings of SpO2,

PR, and PA

①

②

③

Emitter Detector

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DEVICE DESCRIPTION, CONT.

The main features of Oxxiom Pulse Oximetry System

include the following:

• Wireless measurement of oxygen saturation of arterial

hemoglobin (SpO2), pulse rate (PR), and pulse

amplitude (PA).

• Warnings, visual and audible.

• Voice-based measurements for SpO2, PR, and PA

every 30, 60, or 120 seconds.

• Storage and data sharing for measurement trends on

SpO2, PR, and PA (12, 24, 36, or 48 hours) and

waveforms (last 12 hours).

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DEVICE DESCRIPTION, CONT.

Deﬁnition of featured measurements

• SpO2 is the functional saturation of peripheral oxygen.

It is the percentage ratio of oxygenated hemoglobin

concentration over the total concentration of

oxygenated and non-oxygenated hemoglobin.

• Pulse Rate, PR, is the number of heartbeats per

minute.

• Pulse Amplitude, PA, is the normalized peak-to-peak

amplitude of the pulsatile signals (plethysmographs)

generated at the measurement site by the heart activity,

and detected by an optical device

(photoplethysmographs). PA values range from 0.02%

(very weak pulsatile signal) to 20% (very strong

pulsatile signal.).

• Waveforms are the pulsatile signals generated at the

measurement site by the heart activity, and detected by

an optical device (photoplethysmographs). Motion in

the measurement site affects the displayed

photoplethysmographs.

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DEVICE DESCRIPTION, CONT.

Measurement site

• Oxxiom has been tested on a subject population with

the device placed on the ﬁnger.

Pros

Cons

• Convenient for patient

in prone or supine

position.

• Higher perfusion in

warm environment.

• Strong vasoconstrictor

response to cold.

• Skin callouses and

deformities may cause

false readings.

• Proper pressure from

tape wrapped around

ﬁnger is important.

• Monitoring at other sites of the body is NOT

RECOMMENDED. Performance at other sites than the

ﬁnger has not been validated.

• Minimize sunlight exposure to Oxxiom device with the

provided tape. An extra covering may be needed.

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PACKAGE LAYOUT AND CONTENTS

• The Oxxiom package contains three items:

1.Oxxiom device.

2.Self-adhering breathable gentle tape for application

to ﬁnger.

3.Label with 2-dimensional UDI and QR barcodes.

• In addition to the three items from the package, the

Oxxiom Pulse Oximetry System requires the Oxxiom

Rx App.

• Download the Oxxiom Rx App from the Apple's App

Store (purchase necessary).

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PACKAGE LAYOUT AND CONTENTS, CONT.

Blister

pack

Anti-tamper

tab

Front view Back view

Isometric view

Oxxiom

device

①

Self-

adhering

breathable

gentle

tape roll

Blister

pack label

with

Barcodes

②

③

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Oxxiom Rx

On the iOS device:

(i)Select App Store

(ii)Search for

Oxxiom Rx in the

App Store

(iii)Select Oxxiom Rx

to download App

The Oxxiom Rx

App will be now

available in your

iOS device

①

USING THE OXXIOM PULSE OXIMETRY

SYSTEM

Download the Oxxiom Rx App. Internet access is required when

downloading the Oxxiom Rx App from the App Store.

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Tear off

anti-tamper tab.

You may also

use scissors to

cut off tab

②

USING THE OXXIOM PULSE OXIMETRY

SYSTEM, CONT.

Open the blister pack containing the device and self-

adhering tape for ﬁnger application. Keep the blister pack

label for scanning.

Pull off back lid

and blister pack

label with barcodes

③

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Pull out Oxxiom

and self-adhering

breathable gentle

tape roll from blister

pack. Save label

with barcodes for

later use

④

USING THE OXXIOM PULSE OXIMETRY

SYSTEM, CONT.

Front view Back view

QR barcode

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