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: 650-397-6103
Fax: 650-397-6105
Distributed in the USA by:
DynoSense Corp.
100 Century Center Court, Suite 650
Sam Jose, CA 95112
Phone: 650-397-6103
Fax: 650-397-6105
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
DynoSense Corp. – PRQ-00100-01, Rev A Page 6 of 19
Chapter 1 – General Information
DynoSense V1000 system consisting of Dyno100 (Device+Case+Charging Cable, Hydrogel and Sanitizing
Wipe) is a vital monitoring system intended to measure Electrocardiograph (ECG), functional oxygen
saturation of arterial hemoglobin (SPO2), photoplethysmography (PPG), Respiration Rate (RR), Oral Body
Temperature (TEMP), and Breath Alcohol Content (Ethanol) percentage.
Wireless Technology
DynoSense System uses wireless techniques to transmit data. The wireless link uses the Bluetooth BLE V4.1,
transmitting at 2.4GHz. As with any wireless system, it is possible to disrupt communications if there is a
high amount of RF interference or if the maximum wireless link range has been exceeded. The maximum
range specified for this technology is about 10 feet, line of sight. If too much interference is detected or if the
user has gone out of range, the link between the sensor and iPhone will be suspended.
Patient data and configuration are transmitted through a secure, encrypted link in order to protect the user
from unauthorized access.
iOs Device is compatible and is version V5.0 or higher. Wireless internet connection provide by a router is
compatible with Wi-Fi IEEE 802.11 b/g standard and supports WEP WPA and WPA2 personal security
modes.
Indications for Use
DynoSense system consisting of multi-functional scanner and cradle is intended for monitoring physiological
data within inpatient, outpatient or home settings. This includes: Electrocardiograph (ECG), functional
oxygen saturation of arterial hemoglobin (SPO2), photoplethysmography (PPG), Respiration Rate (RR), Oral
Body Temperature (TEMP), and Volatile Organic Compounds (VOC) level.
The system is intended for use on general care patients (including home use) who are at least 18 years of age.
It is not intended for use on critical care patients.
DynoSense Corp. – PRQ-00100-01, Rev A Page 7 of 19
System Set-up Instruction:
What you need to get started:
1. An iPhone is required in order to use the Dyno 100 for the DynoLife app.
2. Charging cable wall to connect case to the computer or charging block.
a. Charging block is not included in the box and should be provided by the user.
Unpack:
1. Remove the protective outer sleeve from the Dyno 100 box by gently sliding it off.
2. Save the protective outer sleeve, as it contains important information that you may need later for
reference.
3. Open the protective box and remove the plastic case.
4. Ensure the following is included in the box:
a. Dyno sensor
b. Charging Cable
c. Hydrogel
d. Sanitizing Wipes
Prepare Dyno 100 Sensor for use:
1. Plug the small end of the charging cable into the plastic case, and then plug the other end of the cable
into a charging block or plug into laptop computer USB port.
2. The Dyno sensor is automatically charged and sanitized when it’s placed in the case. Note: sanitization
begins when the case top is closed, and cable is plugged into a USB charger that is plugged into wall
outlet or a computer USB port.
a. Flashing light on the back of the case indicates that the Dyno is being sanitized. Case must be
closed for sanitization
3. Continue charging until the green LED indicator light is on.
a. Charger LED indication is: red = need charge, amber = charging, green = charged).
b. Battery is charged through inductive charging and is compatible with Qi (inductive power
standard).
4. Additional sanitization can be achieved by wiping the tip and mouthpiece with a sanitizing wipe.
Sanitizing wipes are intended for single use only.
Download and Install the App:
a. From the iPhone, click on the “App Store” (Figure-1).
b. Go to “Search”, type in “DynoLife”
c. When DynoSense” app appears on the screen, select “Get” (Figure-3) to download the App.
d. When the download is successfully complete, “DynoSense” App will be added to the iPhone, and
instruction video opens (Figure-3).
DynoSense Corp. – PRQ-00100-01, Rev A Page 8 of 19
App Store
Tap on Get
Tap on “Create
Account” to sign in
Figure-1 Figure-2 Figure-3
Watch Instruction Video:
a. Tap on the red play button (Figure-3) to watch a 30-45 seconds video covering the following
topics: following topics:
1. Trouble shooting
2. Sign up and complete profile
3. Pairing the device with iPhone
Sign up and Complete Profile:
a. Tap on “Create Account” to sign up a new account. If you already have an account set up with
DynoSense, tap on “Login” to continue (Figure-4).
Figure-4
DynoSense Corp. – PRQ-00100-01, Rev A Page 9 of 19
Tap on “Complete Profile”
after you logged in, or tap on
side menu later to earn more
points by completing profile
Figure-5
Tap each field and
update with accurate
information
b. Complete Profile
After you signed up or logged in, you can either “Complete Profile” to fill in your detail information for a
better health result or complete it later (Figure-5).
Figure-6
Pairing the Devices:
a. Tap on “Capture” before pairing the device with iPhone (Figure-7)
b. Turn on “Bluetooth” on your iPhone
1. Go to Setting
2. Select Bluetooth
3. Tap on the Bluetooth radio button to turn green
c. Tap on Settings to go back to the main screen
DynoSense Corp. – PRQ-00100-01, Rev A Page 10 of 19
Tap to turn green
Tap Settings to go back
Figure-7
d. Complete paring the device and get ready to start capturing data (Figure 8)
DynoSense Corp. – PRQ-00100-01, Rev A Page 11 of 19
Figure-8
How to use Dyno 100:
1. Make sure your iPhone is turned on.
2. Make sure the Dyno sensor has been charged (green light will indicate fully charged) and sanitized prior
to use.
3. For best results, remove the hydrogel from the case and gently squirt a tiny, thin dot of gel on left
THUMB (if you run out of hydrogel, you can still use the sensor).
4. While sitting down, place your left arm on a table for stability.
5. Hold the Dyno sensor in your LEFT hand. (Figure-9)
6. Insert your FOREFINGER underneath the moveable cover and place THUMB on the sensor located
underneath. Your left hand fingers should not rest on top of Dyno cover. Rest your elbow comfortably on
a firm surface.
7. Insert the sensor tip under your tongue, and make sure that the opening of the sensor is above the tongue,
so you can breathe into the opening.
8. BREATHE normally into the opening (do not blow) until completion beep is heard (in less than 60
seconds).
9. Remove the Dyno from your mouth, remove your forefinger and thumb from the sensor, wipe the
mouthpiece and underneath sensor clean with sanitizing wipe, and replace the Dyno into the case,
positioning it correctly, so the LED light will change color.
Figure-9, Dyno Sensor use instruction
Cleaning and Sanitizing
Cleaning
Alcohol wipes are used to clean the surface of the Dyno Sensor, case, and cable. IPA (80-20 Isopropyl
alcohol) based alcohol wipe packets for surface cleaning are provided initially, and can be purchased from
commercially available stores (CVS pharmacy, Rite Aid, target, Walmart, etc.).
Sanitizing
Dyno Sensor is automatically sanitized by a UV light inside the Case, when Dyno Sensor is placed in the case
and the lid is closed. An indicating light on the back of the case indicates UV sanitizing operation. The UV
light is UVC (254 nm) standard wavelength for sanitization.
DynoSense Corp. – PRQ-00100-01, Rev A Page 12 of 19
The following marking information is placed on the Sensor:
The following marking information is placed on the package:
Additional information not on the marking:
Underwriters Laboratories
MEDICAL — PATIENT MONITORING EQUIPMENT
AS TO ELECTRICAL SHOCK, FIRE AND MECHANICAL
HAZARDS ONLY
IN ACCORDANCE WITH
ANSI/AAMI ES60601-1 (2005), "Medical Electrical Equipment - Part 1:
General Requirements for Basic Safety and Essential Performance;
CAN/CSA-C22.2 No. 60601-1:08; ANSI/AAMI/IEC 60601-2-25,
"Medical Electrical Equipment - Part 2-25: Particular Requirements for
the Basic Safety and Essential Performance of Electrocardiographs"
DynoSense Corp. – PRQ-00100-01, Rev A Page 13 of 19
Clinical Restrictions:
SpO2
1. As the measure is taken on the basis of arteriole pulse, substantial pulsating blood flow of subject is
required. For a subject with weak pulse, low ambient/body temperature, major bleeding, or use of
vascular contracting drug, the SpO2 waveform (PLETH) will decrease. In this case, the measurement
will be more sensitive to influence.
2. For those with a substantial amount of staining dilution drug (such as methylene blue, indigo green
and acid indigo blue), or carbon monoxide hemoglobin (COHb), or methionine (Me+Hb) or
thiosalicycle hemoglobin, and some with icterus problem, the SpO2 determination by this monitor
may be inaccurate.
3. The drug like domamine, procaine, prilocaine, lidocaine and butacaine may also be a major factor
blamed for serious error of SpO2 measure.
4. As the SpO2 value serves as a reference value for judgement of anemic anoxia and toxic anoxia,
some patients with serious anemia may also report good SpO2 measurement.
DynoSense Corp. – PRQ-00100-01, Rev A Page 14 of 19
Life of the Device:
Recommend life of Sensor is 2 years
Recommended shelf life of the Sensor is 18 months
Recommendations:
Recommend gently wiping the sensor module with a sanitizing alcohol wipe after every use
Recommended operating temperature range: 10 - 40 deg C
Recommended shipping and storage temperature range: 0 – 40 deg C
Recommended shipping and storage relative humidity range: 10 – 95% RH
Recommended operating relative humidity range: 10 – 95% RH
Recommended operating altitude: < 2000 m
Recommended barometric pressure: 80 kPa
FCC:
FCC ID: 2AHYU-9990010001
IC: 21382-9990010001
FCC part15.19(3):
All other devices shall bear the following statement in a conspicuous location on the device:
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.
FCC part15.21:
The user’s manual or instruction manual for an intentional or unintentional radiator shall caution the user that
changes or modifications not expressly approved by the party responsible for compliance could void the user's
authority to operate the equipment.
IC RSS-Gen section 8.4
English
This device complies with Industry Canada’s licence-exempt RSSs. Operation is subject to the following two
conditions:
(1) This device may not cause interference; and
(2) This device must accept any interference, including interference that may cause undesired operation of the
device.
French
Le présent appareil est conforme aux CNR d’Industrie Canada applicables aux appareils radio exempts de
licence. L’exploitation est autorisée aux deux conditions suivantes :
(1) l’appareil ne doit pas produire de brouillage;
(2) l’utilisateur de l’appareil doit accepter tout brouillage radioélectrique subi, même si le brouillage est
susceptible d’en compromettre le fonctionnement.
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 (FCC Title 47,
Subpart A, Part 15.19(3)).
Changes or modifications not expressly approved by the party responsible for compliance could void
the user’s authority to operate the equipment (FCC Title 47, Subpart A, Part 15.21)
General Information
This section provides general information on the System.
DynoSense Corp. – PRQ-00100-01, Rev A Page 15 of 19
Electromagnetic Compatibility (EMC):
The System may need special precautions regarding EMC and should be used according to the EMC
information provided in the “Warning” and “Caution” sections of this document.
Portable and mobile RF communications equipment can affect the sensor, cradle or scale. See Medical
Electrical Equipment user manual for RF communication precautions.
Type of radio modulation, frequency and antenna power is follows:
o Radio modulation: FSK (frequency shift keying)
o Frequency: 2.4 – 2.5GHz
o Antenna power: 4dbm
Electromagnetic Emission Declaration
The system is intended for use in the electromagnetic environment specified below. The end user should
assure that it is used in such an environment.
Emission test
Compliance
Electromagnetic environment
RF emissions CISPR 11
Group 1
The cradle uses RF energy only for its internal function.
Therefore, its RF emissions are very low and are not likely
to cause any interference in nearby electronic equipment.
RF emissions CISPR 11
Class B
The sensor is suitable for use in all establishments,
including domestic establishments and those directly
connected to the public low-voltage power supply network
that supplies buildings used for domestic purposes.
Guidance and declaration – electromagnetic immunity
(For ME equipment ME system that are not life-supporting)
The System is intended for use in the electromagnetic environment specified below. The end user of
should assure that it is used in such an environment.
Immunity test
IEC 60601
test level
Compliance
level
Electromagnetic environment- guidance
Radiated RF
IEC 61000-4-3
3 V/m
80 MHz to
2.5 GHz
3 V/m
Portable and mobile RF communications equipment
should be used no closer to any part of the System than
the recommended separation distance calculated from
the equation applicable to the frequency of the
transmitter.
Recommended separation distance
d = 1,2√p 80 MHz to 800 MHz
d = 2,3√p 800 MHz to 2.5 GHz
Where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended separation
distance in meters (m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site surveya should be
less than the compliance level in each frequency range b.
Interference may occur in the vicinity of equipment
marked with the following symbol:
DynoSense Corp. – PRQ-00100-01, Rev A Page 16 of 19
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects, and people.
a
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and
land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted
theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an
electromagnetic site survey should be considered.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Recommended separation distances between
Portable and mobile RF communications equipment and the Sensor (Dyno 100)
Dyno 100 sensor is intended for use in an electromagnetic environment in which radiated RF disturbances
are controlled. The customer or the user of Dyno 100 sensor can help prevent electromagnetic
interference by maintaining a minimum distance between portable and mobile RF communications
equipment (transmitters) and Dyno 100 sensor as recommended below, according to the maximum output
power of the communications equipment.
Rated maximum output power of
transmitter
W
Separation distance according to frequency of transmitter
m
150 kHz to 80 MHz
d = 1,2√p
80 MHz to 800 MHz
d = 1,2√p
800 MHz to 2.5 GHz
d = 2,3√p
0.01
NA
0,12
0,23
0.1
NA
0,38
0,73
1
NA
1,2
2,3
10
NA
3,8
7,3
100
NA
12
23
For transmitters rated at a maximum output power not listed above, the recommended separation distance
d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter. Where
p is the maximum output power rating of the transmitter in watts (W) according to the transmitter
manufacturer.
Note 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is effected by
absorption and reflection from structures, objects and people.
Guidance and declaration – electromagnetic immunity
(For ME equipment ME system that are not life-supporting)
The System is intended for use in the electromagnetic environment specified below. The end user should
assure that it is used in such an environment.
Immunity test
IEC 60601 test
level
Compliance
level
Electromagnetic environment- guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
± 6 kV contact
± 8 kV air
± 6 kV contact
± 8 kV air
Floors should be wood, concrete, or ceramic
tile. If floors are covered with synthetic
material, the relative humidity should be at
least 30 %.
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
3 A/m
0.3 A/m
Power frequency magnetic fields should be
at levels characteristic of a typical location
in a typical commercial or hospital
environment.
NOTE: UT is the a.c. mains voltage prior to application of the test level.
DynoSense Corp. – PRQ-00100-01, Rev A Page 17 of 19
Problem
Solution
Dynolife can’t find the sensor
when trying to add new sensor.
Make sure you take the sensor out from case and the sensor is power on.
(Sensor bottom light is green). If still can’t find the sensor, put the sensor
back to the case and reset it
Bluetooth connection failed.
1. Make sure you take the sensor out from case and the sensor is power
on. (Sensor bottom light is green or blue). If still failed, put the sensor
back to the case and reset it.
2. If Step 1 didn’t work, turn off and turn on the Bluetooth of your iOS
device.
3. If Step 1 and 2 didn’t work, restart your iOS device.
No Cloud Error.
1. Make sure you are connected to internet.
2. If internet connection is not good, please try again.
Trouble Shooting:
For complete troubleshooting watch the instructional video downloaded on your iPhone (after DynoSense
App is downloaded), see table below or go to Visit www.dynosense.com.
For DYNO technical support, or call 1-xxx-xxx-xxxx
DynoSense Corp. – PRQ-00100-01, Rev A Page 18 of 19
Symbol
Title
IPX4
Protected against splashing water
Operating instruction
Follow operating instruction
Non-ionizing radiation
Defibrillation proof type CF applied part
Type B applied part
Manufacturer
Do not dispose in household trash
Recycle
Underwriters Laboratories
MEDICAL — PATIENT MONITORING EQUIPMENT
AS TO ELECTRICAL SHOCK, FIRE AND MECHANICAL
HAZARDS ONLY
IN ACCORDANCE WITH
ANSI/AAMI ES60601-1 (2005), "Medical Electrical Equipment - Part 1:
General Requirements for Basic Safety and Essential Performance;
CAN/CSA-C22.2 No. 60601-1:08; ANSI/AAMI/IEC 60601-2-25,
"Medical Electrical Equipment - Part 2-25: Particular Requirements for the
Basic Safety and Essential Performance of Electrocardiographs" E358758
0843
CE Marking conformity
General symbols
DynoSense Corp. – PRQ-00100-01, Rev A Page 19 of 19
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