DynoSense 9990010001 Users Manual

V1000 System

Instructions for Use

PRQ-00100-01

DynoSense Corp. – PRQ-00100-01, Rev A Page 1 of 19

Table of Contents

Preface ........................................................................................................................................................ 3

Copyright Notice ........................................................................................................................................ 3

Warranty ..................................................................................................................................................... 3

Limited Warranty ........................................................................................................................................ 3

Purpose of this Manual ............................................................................................................................... 4

Safety 5

Chapter 1 – General Information 7

Wireless Technology .................................................................................................................................. 7

Indications for Use ...................................................................................................................................... 7

System Set-up Instruction: .......................................................................................................................... 8

Cleaning and Sanitizing ............................................................................................................................ 12

Clinical Restrictions:................................................................................................................................. 14

General Information .................................................................................................................................. 15

Trouble Shooting: ..................................................................................................................................... 18

General symbols ....................................................................................................................................... 19

DynoSense Corp. – PRQ-00100-01, Rev A Page 2 of 19

Preface

V1000 System (also known as Dyno 100) which includes:

 Device: model # Dyno101, P/N 999-00101-01
 Case: Model # Dyno102, P/N 999-00102-01

Part Number: 999-00100-01

IEC 60601

CE Mark Complies with the Council Directive 93/42/EEC Manufactured by:

DynoSense Corp.
100 Century Center Court, Suite 650
Sam Jose, CA 95112
Phone: [phone]
Fax: [phone]

Distributed in the USA by:
DynoSense Corp.
100 Century Center Court, Suite 650
Sam Jose, CA 95112
Phone: [phone]
Fax: [phone]

Copyright Notice

Copyright © 2015 DynoSense Corp. All rights reserved.

This document may not be copied, photocopied, reproduced, translated, or reduced to any electronic medium or
machine-readable form, in whole or in part, without the prior written consent of DynoSense corp.

License to use the software to operate the System is granted. No permission is given to use this system in a
manner not related to the intended operation of this device. The system software and hardware may not be
copied or supplied to any third party without permission from DynoSense Corp.

Warranty

NOTICE: Manufacturer’s Specifications and Policies Subject to Change. DynoSense Corp. reserves the right to

make changes in the products described in this manual in order to improve design or performance. Reproduction
or distribution of any portion of this manual without the prior written consent DynoSense Corp is prohibited.

Limited Warranty

Subject to the conditions and limitations on liability stated herein, the System as so delivered, shall materially
conform DynoSense’s then current specifications for the System (from here on known as the System), for a
period of one year from the date of delivery. ANY LIABILITY OF DynoSense Corp. WITH RESPECT TO
THE SYSTEM OR THE PERFORMANCE THEREOF UNDER ANY WARRANTY, NEGLIGENCE,
STRICT LIABILITY OR OTHER THEORY WILL BE LIMITED EXCLUSIVELY TO SYSTEM REPAIR,
REPLACEMENT OR, IF REPLACEMENT IS INADEQUATE AS A REMEDY OR, IN THE OPINION OF
DynoSense Corp., IMPRACTICAL, TO REFUND OF THE PRICE PAID FOR THE SYSTEM. EXCEPT FOR
THE FOREGOING, THE SYSTEM IS PROVIDED “AS IS” WITHOUT WARRANTY OF ANY KIND,
EXPRESS OR IMPLIED,

DynoSense Corp. – PRQ-00100-01, Rev A Page 3 of 19

Additionally, this warranty does not apply if:

1) The System is operated in other than a manner prescribed by DynoSense Corp.

2) The System is operated in a manner that is not in conformance with purchase specifications and specifications
contained in the System.

3) The System is not maintained in accordance with procedures and processes defined in this Instruction for
Use, the System Instructions for Use.

4) The System is repaired, altered, or modified in any way by other than DynoSense Corp. authorized personnel,
or without DynoSense Corp. authorization. Contact DynoSense Corp. for instructions and issuance of a Return
Material Authorization if claims under this warranty become necessary and if the System or components of the
System are to be returned. The System or components will not be accepted for warranty purposes unless the
return has been authorized by DynoSense Corp.

System parts or components repaired or replaced under warranty bear the same warranty expiration date as the
original equipment. The System or accessories purchased outside the original warranty period are warranted for
a period of 90 days, subject to all of the restrictions contained in this Limited Warranty. Use of unauthorized
replacement parts may void the warranty. In all cases, DynoSense Corp. will be the sole judge as to what
constitutes warrantable damage.

Purpose of this Manual

This instruction manual is designed for use by the end users (patient) and health care professionals to provide
clinical and technical information about the safe use of the System V1000 System family. This manual should
be read and understood prior to the use of V1000 System.

DynoSense Corp. – PRQ-00100-01, Rev A Page 4 of 19

No modification to the System is permitted. DO NOT DISASSEMBLE

Do not use, without the consent of your healthcare provider.

All components of the System should be kept out of the reach of children, pets, or anyone who
may be at risk of being harmed by components. Seek emergency medical attention immediately.

Do not share your Sensor with others to avoid potential risk of contamination.

Do not use with a defibrillator.

Do not use soap or chemicals to clean the Dyno sensor.

Do not immerse in water.

Do not use while in bathtub or shower

To be used only by adults over age 18

No modification to the System is permitted. DO NOT DISASSEMBLE.

If any component of System fails to operate after attempting all suggested troubleshooting
methods, contact your product provider immediately.

Do not dispose system parts (sensor and scale) in a household trash bin. Return parts to DynoSense
for disposal.

Keep System (sensor/device and case) away from excessive heat exposure, as this may cause
damage. Recommended operating temperature range: 10 - 40 degrees C. Recommended operating
relative humidity range: 10 – 95% RH

Always store your Dyno in the case when not in use.

Place the Dyno case on a firm surface near a wall outlet.

Do not drop, especially onto hard surfaces.

To be inserted only into the MOUTH.

Safety

Carefully read and review this entire the following instruction safety warning and caution before operating the
system.

Warnings

Caution

DynoSense Corp. – PRQ-00100-01, Rev A Page 5 of 19

The System has been tested by UL for electrical safety test, and complies with the applicable requirements.

The System has been tested by UL for FCC compatibility in accordance with ANSI C63.10-2013, FCC CFR 47
Part 2, FCC CFR 47 Part 15, RSS-GEN Issue 4, and RSS-247 issue 1, and it meets the applicable requirements.

The System is RoHS compliant.

The System software failure, firmware failure or battery failure has no adverse effect on the end-user. The failure
would disable vital data collection and transmission.

The System has been tested for ingress protection, and it meets IPX4 protection.

No installation or maintained is required for using the System. Follow Set-Up procedure described in this
document.

No cable is required for operation. Follow Set-Up procedure described in this document.

If the unit is dropped onto a hard surface from a height of approximately 3’, more than 3 times OR dropped onto

a soft surface from a height of approximately 5’, more than 3 times, the sensor may sustain physical and

functional damage. If this occurs please contact DynoSense Corp for assistance.

General

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