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TRANSCRIPT
Section 11CardioSleeve: User Manual
CardioSleeve v . User Ma ual
2
CardioSleeve v . User Ma ual
This manual is also available online at: www.rijuven.com/
Section 1: Disclaimers
Copyright © 2013 Rijuven Inc. All rights reserved. Rijuven and CardioSleeve are registered trademarks of Rijuven Inc.
Disclaimer and Limitation of Liability
Rijuven assumes no responsibility or liability for any damage and/or loss resulting from the use of this manual.
Rijuven reserves the right to alter the content of this User Manual and any specifications regarding the CardioSleeve
device in accordance with FDA regulation without prior notice.
Declaration of Conformity
This declaration of conformity is supported by the Quality System
Requirement ISO 9001:2000, ISO 13485:2003 and
ISO 9000-3:1997
Ma ufa turer s Na e: Manufactured by Rijuven Corp. 624 Whispering Pines Drive, Pittsburgh, PA 15238
The manufacturer declares that the product:
• Produ t Na e: CardioSleeve
• Model Na e: v1.0
• De i e lass: IIaConforms to the following Product Specifications [EDIT]:
• “afet : IEC -1-2:2007 and the specifications as shown in Table 2:
Regulatory Approval Status –Pending-
3
Introduction 5
Features 5
Device Features 5
Package Contents 5
Online Ordering Details 6
Disclaimers 7
General Information 7
Device Description 7
Device Indications for Use 7
Precautions and Warnings 8
General Warnings 8
Precautions 8
System Requirements 9
Patient Privacy 9
Licensing Agreement 9
Clinician's Responsibility 10
Getting Started 11
CardioSleeve Device and Software Setup 11
Register your CardioSleeve 12
Device Diagram 12
LED Status Diagram 12
CardioSleeve Screens 13
Use Instructions 1
Software Basics 14
Choosing a Patient 14
Creating a New Patient 15
Recent Patient Lists 15
Performing Diagnostic Exams 1
Auscultation with ECG 16
Start a Recording Sequence 16
Signal Quality 17
Review of Patient Findings 17
Re-record a Specific Auscultation Location 17
Repeat Auscultation Sequence for an Existing Patient 17
Viewing and Interpreting Result Details 18
Location Details 18
Pathology Detection 18
Heart Rate 18
Viewing and Replaying Tracings 18
Patient Positioning 18
Caliper Measure 18
Interval Guide 18
Notes 18
Viewing and Replaying Tracings 19
Auscultation with ECG Playback 19
Pinch/ Zoom Display 19
Caliper Measurement 20
3 Lead ECG 21
4
Start a Recording Sequence 21
Device Lead Placement 21
Signal Quality 22
Review of Patient Findings 22
Re-record a Specific ECG Lead 22
Repeat 3 Lead ECG for an Existing Patient 22
Viewing and Interpreting Result Details 23
Lead Details 23
Heart Rate 23
View Tracings 23
View Multiple Tracings 23
Caliper Measurement 23
Interval Guide 23
Notes 23
Viewing Tracings 24
Pinch/ Zoom Display 24
Caliper Measurement 25
Cardiac Index 26
Recorded Results 27
Historic Results 27
Trends 27
ECG Historic Comparison 27
Guides
28
Interval Guide 28
Auscultation Technique 28
ECG Technique 28
QTc Interval Alert 28
Cardiac Index 28
CardioSleeve Online 29
CardioSleeve Online Tracings Views 30
Sample Auscultation with ECG View 30
Sample ECG View 30
Sample Online Caliper Measure Interface 30
Sample Printed and .PDF Reports 31
General Care and Maintenance 32
Cleaning 32
Recording Quality 32
General Specifications 34
Electrical Safety Specifications 34
Symbols used for Software, Hardware and Package Labeling 35
Warranty Information 36
Contact Information 36
Appendix 37
A- CardioSleeve Icons, Buttons and Controls 37
5
Introduction
Thank you for purchasing ‘iju e s Cardio“lee e, a stethoscope enhancement that will allow medical professionals to
quickly and accurately assess heart health at any point of care.
For proper application and care of the device, please read through the entire User Manual carefully prior to using your
CardioSleeve, either as an electronic Auscultation with ECG or 3 lead ECG. It is re o e ded to keep the User s Ma ual on hand for later reference, if necessary. As with any medical device, medical professionals are encouraged to acquire
practical experience with the CardioSleeve prior to any clinical use.
Your CardioSleeve device works with CardioSleeve software for heart analysis. CardioSleeve converts your stethoscope
into an electronic stethoscope with digital auscultation and 3 Lead ECG. Together, you will be able to quickly assess the
mechanical behavior and electrical signal of the heart. In addition, clinical decision support software will provide
confidence in your assessment and diagnosis of heart health.
Features
CardioSleeve v1.0 Features:
Universal Stethoscope Attachment
Digital Auscultation with simultaneous ECG
3 Lead ECG
Analysis Software
Digital Caliper
Cardiac Index
Archival and Retrieval of Recorded Results
Device Features
Bluetooth
Lithium-ion Battery
LED Indicators
3 Lead ECG Sensors
Grounding Plate
Micro- Electronic Microphone
Uniform Stethoscope Attachment
Ergonomic Form factor
Patent Pending Design
Your CardioSleeve package contains:
One CardioSleeve device
One DC power charger
One Bluetooth USB Dongle
One Quick Start Guide
One User Manual
Three Rijuven Diaphragms
Three Chill Rings
Cleaning Swabs
6
Online Ordering Details
The following information is collected during the CardioSleeve ordering, registration and setup
process. Please keep this information stored for easy Customer Service access.
Salutation:
First Name:
Last Name:
Business Name:
Address Line 1:
Address Line 2:
City:
State:
Country:
Telephone Number:
Email:
Password:
Confirm Password:
4 Digit PIN:
CC Number:
CC Expiration:
CC Security:
License Number*:
*For Medical Students, Please enter your medical school ID.
I am a:
Allergist
Anesthesiologist
Cardiologist
Dentist
Dental Assistant
Dental Hygienist
Dermatologist
Emergency Medicine
Endocrinologist
ENT
Family Medicine
Gastroenterologist
General Practitioner
Internal Medicine
Neonatal
Nephrologist
Neurologist
OB/GYN
Oncologist
Ophthalmologist
Orthodontist
Orthopedic Surgeon
Pain Management
Pediatrician
Physical Medicine
Plastic Surgeon
Podiatry
Pulmonologist
Radiologist
Sleep Medicine
Surgeon
Urologist
Ph si ia s Assista t
PT/OT/SLP
Nurse Anesthetist
Nurse Practitioner
RN
EMT
Medical Student
Other
7
Disclaimers
All names and diagnoses depicted in examples herein are fictitious. No association with real
persons is intended. Complying with all applicable copyright laws is the responsibility of the user. No
part of this document may be reproduced or transmitted in any form or by any means, or for any
purpose, without the express written permission of Rijuven, Inc.
Rijuven, Inc. may have patents, patent applications, trademarks, copyrights, or other intellectual
property rights covering subject matter in this document. The use of this document does not give
you any license to these patents, trademarks, copyrights, or other intellectual property.
Device Description
The CardioSleeve with Diagnostic Heart Murmur Application is a decision support device intended to
acquire, record, and analyze heart sounds. It is used to distinguish between normal and pathological
heart murmurs by recording the acoustic signal of the heart and the ECG signal simultaneously and
analyzing these signals.
The complete system is a software application comprising the Diagnostic Heart Murmur Algorithm
that runs on a hosted server environment with Linux operating system, a hand held mobile device to
capture patient data, instructions for use and the electronic stethoscope with integrated ECG to
capture the acoustic heart signals. The CardioSleeve Front-end device will interface via Bluetooth with
the hand held mobile device.
The CardioSleeve Diagnostic Heart Murmur Application distinguishes between normal/physiological
and pathological heart murmurs by analyzing the acoustic heart and ECG signals captured with the
CardioSleeve Front-End. The device will record the acoustic sound of the heart at the four main
auscultation locations and a three lead ECG signal. The ECG signal is not intended for diagnostic use,
only to synchronize with the beginning of each heart cycle. The acoustic heart signal is analyzed to
identify heart sounds that may be present, identified sounds include S1, S2 and suspected murmurs.
Device Indications for Use
The CardioSleeve System consisting of the CardioSleeve Front-End stethoscope and ECG device,
mobile heart sound recording application and the remote diagnostic heart murmur software is a
decision support device intended to be used on a single patient to assist the medical examiner in
analyzing cardiac sounds for the identification and classification of suspected murmurs. It is used to
distinguish between normal / physiological and pathological heart murmurs by recording the acoustic
signal of the heart and the ECG signal simultaneously and analyze these signals. The acoustic heart
signal is analyzed to identify specific heart sounds that may be present. Identified sounds include S1,
S2, and suspected murmurs.
CardioSleeve indicates whether or not a recorded heart sound contains a suspected heart murmur.
The device must be used in a clinical setting by trained personnel with the prescribed accessories and
all relevant patient information must be taken into consideration before a diagnosis is made.
The interpretations of heart sounds offered by the CardioSleeve device are only significant when used
in conjunction with physician over-read as well as consideration of all other relevant patient data.
CardioSleeve is not intended to be a diagnostic device. It does not supersede the judgment of the
qualified medical personnel. The device is intended to aid the physician in the evaluation of heart
sounds. The physicians are responsible for reviewing and interpreting the results, along with the
auscultation findings and medical history, when making a referral decision.
Caution: This device is intended for sale to and use by a licensed clinician only.
8
Precautions & Warnings
CardioSleeve General Warnings
A warning statement in this manual identifies a condition or practice, which if
not corrected or discontinued immediately, could lead to patient injury, illness, or death. These
warnings pertain to CardioSleeve:
WARNING: The information in this manual is a comprehensive guide to the operation of
CardioSleeve. For best results, read this manual thoroughly before using the device.
WARNING: CardioSleeve is designed for medical clinician use. Only a trained clinician who
knows how to auscultate and perform an ECG should use this device.
WARNING: CardioSleeve is not intended for use in environments that are without health
care practitioner supervision.
WARNING: CardioSleeve is not intended for continuous monitoring and must not be used as
such. Where continuous monitoring is required, the appropriate equipment must be used.
WARNING: To ensure patient safety, use only accessories and supplies recommended for or
supplied with CardioSleeve.
WARNING: Do not use the CardioSleeve during magnetic resonance imaging (MRI) scanning.
WARNING: Do not use this device with a defibrillator.
WARNING: Keep out of reach of infants, and small children.
WARNING: This device captures and presents data reflecting a patient s physiological
condition. When reviewed by a trained physician or clinician, this data can be useful in
determining a diagnosis. However, the data should not be used as a sole means for
determining a patient s diagnosis or prescribing treatment.
WARNING: Do not use this device in the presence of flammable anesthetics, drugs or
pressurized oxygen (such as hyperbaric chamber, ultraviolet sterilizer or oxygen tent).
CardioSleeve Precautions
A caution statement in this manual identifies a condition or practice, which if not corrected
or discontinued immediately, could lead to equipment failure, equipment damage, or data
loss. These cautions pertain to CardioSleeve.
Caution: The device should not be used in conjunction with water, or in a wet environment.
Caution: Disperse any static electricity from the body before using the unit.
Caution: Do not expose the device to strong shocks or vibrations.
Caution: Do not disassemble, repair, or modify the unit.
Caution: Use only parts and accessories that are supplied with the device and available
through a legal supplier. The use of accessories other than those specified may result in
degraded performance or unsafe use of the software.
Caution: Clean electrode surfaces frequently.
Caution: If the accuracy of any measurement is in question, check the patient s vital sign(s) with
an alternate method and then check to verify if the device is functioning properly.
Caution: Portable and mobile Radio Frequency (RF) communications equipment can affect the
performance of the electrocardiograph.
9
System Requirements
Operating System IOS5 or higher
Mobile platform IPhone 4 or higher, Ipod Touch, Ipad 2 or higher
Audio Input BT
Memory > 512Mb
User Interface Touch Screen
Data Interface TCP/IP
Audio output 3.5mm audio headphone
Minimum 20Hz to 512Hz headphones required
Patient Privacy
The software is used to store personal clinical and medical information. The use, storage and
disclosure of information submitted, created or stored for the application of this software, either
electronically or otherwise, is subject to all international, national, state/provincial and local laws,
practices and regulations that are applicable to you, in particular laws, practices and regulations
relating to privacy, and data, including the use, storage, disclosure and transmission of individually
identifiable information. You are responsible for familiarizing yourself with any such laws, practices and regulations and for
making the necessary arrangements to implement appropriate security measures to control access
to patient data submitted, created and stored in relation to the software. In view of the above, the software permits the disclosure or sharing of heart sound and ECG
recordings without disclosing the patient s identity and no personal information is embedded within
the heart sound and ECG files. Accordingly, the intended user hereby assumes all risks, responsibilities and liabilities associated
with the use, storage, disclosure and/or transmission of information in relation to the software and
Rijuven, Inc. is hereby indemnified from any claims, losses or damages resulting from your actions or
negligence in this regard.
Please consult your institution's information technology department or computer technician to
implement appropriate security measures to protect accessed patient data created and stored
using this software.
Licensing Agreement
Installing this software for the first time allows you to use it to record and store up to 10 patients and
makes you subject to our End User License Agreement. After registration of the software at
www.rijuven.com, you will receive an activation code. This code is linked to the serial number and
registration code of the hardware device. You will be allowed to register the software and sync your
device to any compatible mobile or stationary device.
10
Cli i ia s ‘espo si ilities
This device is intended to be used by licensed medical professionals.
Disclaimer: The user must correlate the consistency between the acquired signal and
interpretation by the software.
Only a physician is responsible for the final interpretation; the Health Care worker can only
make a preliminary assessment.
In case of malfunction remove the CardioSleeve and use the Stethoscope by itself for
auscultation.
For Emergency use, and Rescue the user may want to carry an additional CardioSleeve as
standby.
11
Button
Status LEDs
Record
Bluetooth
Power
A.
B.
Getting Started
CardioSleeve Device and Software Setup
Download CardioSleeve App
Download the CardioSleeve App at
www.rijuven.com -OR- by
sear hi g for Cardio“lee e i the Apple App Store.
On your mobile device, set Bluetooth to ON . Verify the registration information provided for
your account.
Confirm all licensing agreements and legal
disclaimers.
Connect the Device to the Stethoscope
Remove the stethoscope chestpiece from the
stethoscope tubing.
Insert the chestpiece stem to the CardioSleeve
tubing (A).
Connect stethoscope tubing onto CardioSleeve
Stem (B).
The stethoscope will function as originally
indicated while the CardioSleeve is attached.
Power ON the Device
Hold down the device button at the polarity
indicator for 3 Seconds.
The Power LED indicator will be solid.
The Bluetooth indicator will be blinking blue.
Launch App*
Login by entering:
Username (registration email)
Password,
Create and confirm your PIN
Bluetooth Pair the Device
Follow pairing instructions in the app. Once
paired, the Bluetooth LED will be solid blue.
* Your PIN code is used to quickly re-launch the app without
username and password authentication.
Keep your email, password, PIN and Device ID in a safe
place for easy customer service access.
The CardioSleeve app will run in the background as long as
the device is paired.
CardioSleeve
12
Universal Stethoscope
Attachment
ECG Polarity
Indicators
Status LEDs
Record
Bluetooth
Power
Battery Charging Port
Universal Stem for
Tubing Attachment
Grounding Plate
ECG Electrodes
Sound Recorder
Ergonomic Design
Register your CardioSleeve
The CardioSleeve device will be received with
registration information already completed upon
ordering. Upon initial startup of the app, registered
user details are presented in the Home>> Settings>>
User Details section.
This panel is completed upon ordering the device
and should be verified for correctness. Any changes
will be recorded with the registered device and
software service. Changes to PIN and password can
jsmith
Dr.
John
Smith
Device Diagram
Your CardioSleeve device contains these key main features.
LED Status Diagram
Device status can be obtained by using the LEDs on the top side of the device.
Bluetooth Recording Power
Off
Bluetooth Not Connected
Bluetooth Connected
Recording
Battery Status
Device Off
100-61%
60-11%
10-1%
1% or less
13
Home Select Location/Lead Recording Result Details
Pinch Zoom
CardioSleeve Screens
CardioSleeve contains these main diagnostic recording and analysis screens:
Audio/Visual Playback Digital Caliper View Multiple ECG Lead Cardiac Index
CardioSleeve contains these detailed analysis screens:
Patient Exam History ECG Interval History Auscultation History Cardiac Index History
CardioSleeve contains these historic reviews and trend analysis:
14
Demo, Patient 1
Demo, Patient 2
Demo, Patient 3
All New Recent Patient List Instant Exam
Use Instructions
Software Basics
The CardioSleeve App Home Screen contains two functional sections,
Diagnostics and Patient Selection. Once a patient is selected, a diagnostic
can be performed.
Patient Selection A. Choose Patient B. Patient List C. Instant Exam*
Diagnostics D. Auscultation with ECG E. 3 Lead ECG F. Recorded Results G. Cardiac Index
* Instant Exam allows immediate diagnostics without entering patient
details. Patient details can be added at a later time.
D. E. F. G.
A. B. C.
Choosing a Patient
On the Home Screen, patient selection must occur before performing a diagnostic. Patient selection icons:
All Patients
CardioSleeve provides a patient selection interface
that can be used to choose existing patients from
uploaded lists or to create new patients.
CardioSleeve is preloaded with three demo patients
for tutorial purposes. These patients can be deleted
at any time.
Tap on the patient name in the list to select a patient.
The list is alphabetical by last name. Patient selection
can also be made via searching for the patient name.
15
Creating a New Patient
1. On the Home Screen tap the icon for
New Patient.
2. On the Choose Patient screen, enter
the new patient information.
3. Tap Do e . 4. Verify the new patient name as
displayed on the Home Screen.
Demo, Patient 1
Demo, Patient 2
Demo, Patient 3
Choosing from a Recent Patient List
A list of recent patients is automatically created
and can be accessed from the home screen by
tapping this icon. In addition, the Recent
Patient List can be accessed via a tab in the
Choose Patient Screen.
Cardio“lee e o tai s default lists ‘e e t a d I sta t E a s . Additio al lists a e created, and patients can be added to these
additional lists at any time.
Instant Exam
To bypass patient selection to perform an
immediate diagnostic, Instant Exam should be
tapped. Patient, Exam # , will be
automatically selected on the home screen.
Each Instant Exam will be stored in the patient
list s as Patient, Exam # , a d a e edited to include patient information once a test has
been performed and saved.
16
1. On the Home Screen, tap the Auscultation
icon.
2. A chest illustration with four heart sound
locations will be displayed: Aortic, Pulmonary,
Tricuspid, Mitral
3. To begin with an Auscultation with ECG at the
Aortic location, tap the corresponding Aortic
location on the chest illustration. This location
will be highlighted.
4. Place the stethoscope and connected
CardioSleeve device on the corresponding
chest location of the patient.
5. Once the connected stethoscope and
CardioSleeve device is at the correct location,
and distinguishable heart sound can be heard,
press the CardioSleeve device button to
initiate a recording.
6. Tap Record on the app to view and record the
Auscultation with ECG tracings at the Aortic
location. The recording length is defaulted to
15 seconds.
7. When the recording is complete, the recording
will be stored.
8. The Heart Sound Location screen will appear
with a color indicator at the recorded location.
9. This process can be repeated for the remaining
Pulmonary, Tricuspid and/ or Mitral locations.
Cli k Ca el to i terrupt re ordi g at a time.
Auscultation with ECG 3 Lead ECG
Note: Tracing
views can be
toggled between
portrait and
landscape by
rotating the mobile
device accordingly.
Performing Diagnostic Exams
Once a patient is selected, a diagnostic exam can be
perfor ed. Aus ultatio ith ECG a d 3 Lead ECG can be performed in CardioSleeve v1.0.
Auscultation with ECG
CardioSleeve Auscultation with ECG visualizes and
records heart sounds synchronized with ECG. Once
recorded, results are displayed and tracings can be
further analyzed within CardioSleeve software.
To start a recording sequence of Auscultation with
ECG:
17
Auscultation with ECG
Signal Quality
While recording, the signal is displayed in real-time.
If there is excessive noise the signal will display an
error message at the selected location. Recording quality signals for diagnostic purposes
requires practice using a stethoscope. Proper
handling of the stethoscope to minimize external
background noises and hand rub/clicks should be
practiced.
Review of Patient Findings Patient findings are the result and summary of the
auscultation with ECG sequence of a specific
patient. A Results Summary is produced at each
recorded location. Locations in GREEN represent
normal heart sound. Locations in RED represent
pathology. Normal and pathological rhythms are
analyzed by the software, and a confidence interval is
provided along with heart rate.
Once the desired locations are recorded, each
location can be tapped to show the summary for that
location. A confidence level analysis and heart rate are
provided at each location.
Re-record a Specific Auscultation Location
To re-record a specific Auscultation location, tap on
the location and tap Re-Record. Re-Record
functionality is available at any location until the
“top utto is tapped.
Repeat Auscultation Sequence for an Existing Patient
O e the “top utto is tapped, the current
recording sequence will be stored, and the home
screen will be displayed. The same patient will still be
highlighted. A repeat auscultation session, 3 Lead
ECG, Result Review or Cardiac Index can then occur.
18
Auscultation with ECG
Viewing and Interpreting Result Details Tap the Details utto to see result details for ea h recorded location. All four locations are selectable and
further analysis and review can occur within the Details
screen.
Location Details
Tap on any of the four locations to view details. Tapping
the Chest illustration will toggle between the Summary
and Details screens and will default on the selected
location. This screen features:
Pathology Detection (A)
The confidence level gives an indication of the
recordings quality of the recording and the level of
accuracy with which the algorithm determined it could
detect normal or pathological rhythms. If the confidence
level is below 70% for a specific recording, it is
recommended that the recording is repeated, to obtain
optimal results.
Heart Rate (B)
The heart rate of each recording of the auscultation
sequence is shown in beats per minute (bpm). The
average systole and diastole length, which excludes the
s1 and s2 lengths and the R-R interval is also displayed in
milliseconds (ms).
Viewing and Replaying Tracings (C)
To view the recorded tracing, tap the tracing button. This
will display the tracing review screen. (See Viewing and
Replaying Tracings).
Patient Positioning (D)
At each location, the patient position can be changed.
Options are Sitting, Standing, and Supine
Caliper Measure (E)
A digital caliper is included. RR Intervals are automatically
calculated. Tapping on a caliper button for the
corresponding interval will display the tracing review
screen for caliper measure. (See Caliper Measure).
Interval Guide (F)
(See Guides).
Notes (G)
Notes can be entered via on-screen typing or dictation.
A. B.
C. D.
E.
F. G.
19
Auscultation with ECG
Viewing and Replaying Tracings
Tap on any of the four locations to view details.
Auscultation with ECG Playback (A1, A2)
When the View Tracings button is
tapped, the tracing screen will appear
with replay functions.
Play- Tapping the Play button will enable the
audio sound output of the heart sound. This
sound can be obtained through mobile, tablet or
PC speakers or attached headphones.
Pause- The playback of the recorded sound and
tracings can be paused at any time.
1/2x- The playback of the recorded sound and
tracings can be slowed to half speed by tapping
the 1/2x button.
Close- Tapping Close will return to the Details
screen.
Pinch Zoom Display (B1, B2)
Within the playback screen, zooming and scrolling
can also occur. Functionality includes:
Scroll- Sliding one finger across the screen slides
the tracing across the screen.
Pinch / Expand - Using two fingers on the screen
enables zoom in and zoom out. With both fingers
on the screen, pinch fingers together to zoom
out. Expand two fingers apart to zoom in.
Double Tap Zoom- A quick zoom in to 2x can be
achieved with a double tap on the screen.
Double tapping the heart sound tracing creates a
full screen heart sound tracing (B1.) Double
tapping again will show both tracings (A2.).
Double tapping the ECG tracking (B2.) creates a
full screen ECG tracing. Double tapping again will
show both tracings (A2.).
Within the zoom screens, playback, pinch Zoom
and scrolling are available.
Note: Tracing
views can be
toggled between
portrait and
landscape by
rotating the mobile
device accordingly.
A1.
A2.
B1.
B2.
20
Auscultation with ECG
Caliper Measurement
CardioSleeve includes a digital caliper for ECG
interval measurement on the Details Screen
(A). The RR Interval for any ECG tracing is
automatically measured, and an RR accuracy
range is provided on the Details Screen.
Tap the caliper icon to the corresponding
interval to begin a measurement. The Caliper
Screen (B) will appear. Pinch/Zoom
functionality is available.
The starting point for each interval selected
will be automatically estimated based on the
previous measured interval caliper placement.
Drag either of the two circular guides across
the tracings to adjust the caliper measured
distance. Tapping Done will store the caliper
measure and return to the Details Screen with
the measurement listed by the corresponding
interval (C). Once any caliper measure has
been completed, the Caliper Save button will
become active.
Note: Measured intervals can t be re-measured
after saving. See the Guides section to review
an Interval Measurement Guide which can be
accessed via the Details screen.
QTc- Once all Intervals have been measured,
QTc is calculated (D). An alert button will
display the QTc ranges for reference.
A.
B.
Note: Measured
i tervals a t e re-measured after
saving. Once saved,
caliper buttons will
no longer be
available for this
session.
C.
D.
21
Note: Tracing
views can be
toggled between
portrait and
landscape by
rotating the mobile
device accordingly.
3 Lead ECG
CardioSleeve 3 Lead ECG visualizes and records
ECG tracings. Once recorded, results are
displayed and tracings can be further analyzed
within CardioSleeve software.
To start a recording sequence of 3 Lead ECG:
1. On the Home Screen, tap the ECG icon.
2. A chest illustration with three lead position
and location will be displayed: Lead 1,
Lead 2, Lead 3
3. To begin with an ECG at Lead 1, tap the
corresponding lead button on the chest
illustration. This location will be
highlighted.
4. Place the CardioSleeve device on the
corresponding chest location of the
patient, with the polarity indicators in the
location and direction illustrated.
5. Once the CardioSleeve device is at the
correct location, press the CardioSleeve
device button to initiate a recording.
6. Tap Record on the app to view and record
ECG tracings at Lead 1. The recording
length is defaulted to 15 seconds.
7. When the recording is complete, the
recording will be stored.
8. The ECG Details screen will appear and will
be defaulted to the Lead that was
recorded.
9. This process can be repeated for the
remaining ECG Leads.
CardioSleeve Device Placements for ECG
Lead I Lead II Lead III
22
3 Lead ECG
Signal Quality
While recording, the signal is displayed in
real-time. If there is excessive noise the
signal will display an error message at the
selected location. Recording quality signals for diagnostic
purposes requires practice using a
stethoscope. Proper handling of the
stethoscope to minimize external background
noises and hand rub/clicks should be
practiced.
Review of Patient Findings
Patient findings are the result and summary
of the ECG sequence of a specific patient.
Once the desired Leads are recorded, the
Details button can be tapped to show the
summary for that location.
Re-record a Specific ECG Lead
To re-record a specific ECG Lead, tap on the
location and tap Re-Record. Re-Record
functionality is available at any location until
the “top utto is tapped.
Repeat 3 Lead ECG Sequence for an Existing
Patient
O e the “top utto is tapped, the urre t recording sequence will be stored, and the
home screen will be displayed. The same
patient will still be highlighted. A repeat
auscultation session, 3 Lead ECG, Result
Review or Cardiac Index can then occur.
23
3 Lead ECG
Viewing and Interpreting Result Details
Tap the Details utto to see result details for ea h recorded Lead. All three Leads are selectable and further
analysis and review can occur within the Details screen.
Lead Details
Tap on any of the three Leads to view details. Tapping the
Chest illustration or the Leads button will toggle between
the Recording and Details screens and will default on the
selected Lead. This Details screen features:
Heart Rate
The heart rate (A) of each recorded ECG sequence is
shown in beats per minute (bpm). The R-R interval is also
displayed in milliseconds (ms) (B).
View Tracings (C)
To view the recorded tracing, tap the tracing button. This
will display the tracing review screen. (See Viewing and
Replaying Tracings.)
View Multiple Tracings (D)
Multiple tracings can be viewed simultaneously. (See View
Multiple tracings.)
Caliper Measure (E)
A digital caliper is included. RR Intervals are automatically
calculated. Tapping on a caliper button for the
corresponding interval will display the tracing review
screen for caliper measure. (See Caliper Measure).
Interval Guide (F)
(See Guides).
Notes (G)
Notes can be entered via on-screen typing or dictation.
B.
A.
C. D.
E.
F. G.
2
24
3 Lead ECG
Viewing Tracings
Tap on any of the four locations to view
details.
When the View Tracings button is
tapped, the tracing screen will
appear.
Pinch Zoom Display
Within the View Tracings screen, zooming and
scrolling can also occur. Functionality includes:
Scroll- Sliding one finger across the screen
slides the tracing across the screen.
Pinch / Expand - Using two fingers on the
screen enables zoom in and zoom out. With
both fingers on the screen, pinch fingers
together to zoom out. Expand two fingers
apart to zoom in.
Double Tap Zoom- Double tapping the ECG
tracing (A) creates a 2x zoom ECG tracing.
Double tapping again will back to the original
tracing.
Within the zoom screens, Scroll and Pinch
/Expand are available.
View Multiple Tracings- Multiple Leads can be
viewed simultaneously by tapping the Multiple
Tracings button.
All recorded tracings will be viewed on one
screen (B), with Scroll and Pinch/ Expand
functions for each tracing available.
Note: Tracing
views can be
toggled between
portrait and
landscape by
rotating the mobile
device accordingly.
A.
B.
25
3 Lead ECG
Caliper Measure
CardioSleeve includes a digital caliper for ECG
interval measurement on the Details Screen
(A). The RR Interval for any ECG tracing is
automatically measured, and an RR accuracy
range is provided on the Details Screen.
Tap the caliper icon to the corresponding
interval to begin a measurement. The Caliper
Screen (B) will appear. Pinch/Zoom
functionality is available.
The starting point for each interval selected
will be automatically estimated based on the
previous measured interval caliper placement.
Drag either of the two circular guides across
the tracings to adjust the caliper measured
distance. Tapping Done will store the caliper
measure and return to the Details Screen with
the measurement listed by the corresponding
interval (C). Once any caliper measure has
been completed, the Caliper Save button will
become active.
Note: Measured intervals can t be re-measured
after saving. See the Guides section to review
an Interval Measurement Guide which can be
accessed via the Details screen.
QTc- Once all Intervals have been measured,
QTc is calculated (D). An alert button will
display the QTc ranges for reference.
A.
B.
Note: Measured
i tervals a t e re-measured after
saving. Once saved,
caliper buttons will
no longer be
available for this
session.
C.
D.
26
Cardiac Index
Cardiac Index can be calculated using data acquired from
an Auscultation with ECG. To obtain Cardiac Index:
1) Tap the Cardiac Index Icon
2) Enter Height
3) Enter Weight
4) Enter Age
5) Enter Blood Pressure Systolic
6) Enter Blood Pressure Diastolic
7) Tap Calculate
The Cardiac Index Estimate screen will appear. This
screen provides the following metrics:
BMI
BSA
MAP
Cardiac Output
Cardiac Index
Range Guides are also provided for MAP and Cardiac
Index.
Parameters That Affect Cardiac Output
Heart rates of 50-150/minute are usually associated with
an acceptable cardiac output. Variations in this range are
person-specific. Athletes often enjoy a wider range while
those with cardiac disease tend to have a narrower
effective heart rate range.
As a general rule, a patient with a heart rate that is too
fast >150/minute or too slow < 50/minute requires
urgent assessment for signs and symptoms of shock.
Both extreme rates can be associated with inadequate
cardiac output.
Atrial fibrillation can reduce cardiac output by as much
as 35% with the loss of atrial kick.
Rijuven Cardiac Index Disclaimer: Cardia I de uses “tarr s for ula number 72
1 for Stroke Volume, created in 1954. The formula has
been used for many years clinically with good precision1. The
medically well-established formula1 for cardiac index is: CI=CO/BSA =
SV*HR/BSA where CI=Cardiac index, BSA=Body surface area,
SV=Stroke volume, HR=Heart rate, CO=Cardiac output. 1 Starr I. Clinical Tests of Simple Method of Estimating Cardiac Stroke
Volume from blood pressure and age. Circulation 1954:9:664-681, 1
Webb Watts R. Clinical Guides in Shock. Medical Times
1961;89:1271-1275 Webb Watts R. Simple method for evaluating
cardiac output. J La State Med Soc. 2009 Sep-Oct;161(5):287-9.
Burkhart K. Theoretical verification of Isaac Starr's formula for the
calculation of stroke volume. Bibl Cardiol. 1969;24:57-62.1
AMERICAN JOURNAL OF CRITICAL CARE, May 2011, Volume 20, No. 3,
page 211 http://www.aacn.org/wd/Cetests/media/a1120032.pdf
27
Recorded Results
The Recorded Results section provides access
to all previously recorded patient sessions.
Individual Sessions and historical trends can be
viewed and analyzed. To view recorded
results, a patient must first be selected.
Tap on the Recorded Results icon. A list of
previous diagnostic exams will be displayed.
Diagnostic exams will be listed in chronological
order. Auscultation with ECG, 3 Lead ECG and
Cardiac Exam recorded results are available.
Auscultation locations showing Pathology and
Cardiac Index ranges are provided in red (A).
The following key shows each diagnostic exam
type:
Cardiac Index
Auscultation with ECG with Pathology
Auscultation with ECG without Pathology
3 Lead ECG
Taping on any diagnostic exam in the list will
present the Historic Details Screen.
Trends
To view trends for any recorded results, tap
the Trends button. Auscultation with ECG, ECG
Interval and Cardiac Index trends are available
(B).
ECG Historic Comparison
In the ECG Historic Details Screen, the ability to
compare tracings from multiple previous
diagnostic exams is available. On this screen
tap Compare with last two historic exams to
view the previous three recorded ECG exams
on the same screen (C). Scroll and Pinch/Zoom
functionality is available.
A.
B.
C.
28
Guides
CardioSleeve contains multiple guides that can be
accessed via the software. Tap this icon to review
a guide where available.
Interval Guide (A)
ECG Details Screen
Auscultation Technique (B)
Auscultation Location Selection Chest Screen
ECG Technique (C)
ECG Lead Selection Chest Screen
QTc Interval Alert (D)
ECG Details Screen
Cardiac Index
Cardiac Index Screen
Parameters That Affect Cardiac Output
Heart rates of 50-150/minute are usually
associated with an acceptable cardiac output.
Variations in this range are person-specific.
Athletes often enjoy a wider range while those
with cardiac disease tend to have a narrower
effective heart rate range.
As a general rule, a patient with a heart rate that
is too fast >150/minute or too slow < 50/minute
requires urgent assessment for signs and
symptoms of shock. Both extreme rates can be
associated with inadequate cardiac output.
Atrial fibrillation can reduce cardiac output by as
much as 35% with the loss of atrial kick.
Rijuven Cardiac Index Disclaimer: Cardia I de uses “tarr s formula number 72
1 for Stroke Volume, created in 1954. The
formula has been used for many years clinically with good
precision1. The medically well-established formula
1 for
cardiac index is: CI=CO/BSA = SV*HR/BSA where CI=Cardiac
index, BSA=Body surface area, SV=Stroke volume, HR=Heart
rate, CO=Cardiac output. 1 Starr I. Clinical Tests of Simple Method of Estimating
Cardiac Stroke Volume from blood pressure and age.
Circulation 1954:9:664-681, 1 Webb Watts R. Clinical Guides
in Shock. Medical Times 1961;89:1271-1275 Webb Watts R.
Simple method for evaluating cardiac output. J La State Med
Soc. 2009 Sep-Oct;161(5):287-9. Burkhart K. Theoretical
verification of Isaac Starr's formula for the calculation of
stroke volume. Bibl Cardiol. 1969;24:57-62.1 AMERICAN
JOURNAL OF CRITICAL CARE, May 2011, Volume 20, No. 3,
page 211
http://www.aacn.org/wd/Cetests/media/a1120032.pdf
D.
B. C.
A.
29
CardioSleeve Online
CardioSleeve Online provides physician access to patient historical recordings. Login to
access recorded auscultations, 3-Lead ECGs and Cardiac Index for all patients that have been
provided a CardioSleeve screening.
Clicking on a patient will produce a patient screen. The left side displays previous recorded
diagnostic exams. The right side displays the historic details screen for the selected exam.
Full functionality is available including viewing tracings, replay of audible heart sound, and
generating PDF files for printed or EHR reports.
To access CardioSleeve Online, visit: www.rijuven.com a d li k Logi . As soon as a new patient is registered on CardioSleeve program, all the details are
automatically saved to CardioSleeve Online for archival and on-demand retrieval. The
patient s data can be recalled by name, ID or date of recording.
30
CardioSleeve Online Tracing Views Sample Auscultation with ECG View
Sample 3 Lead ECG Views
Sample Online Caliper Measurement Interface
31
CardioSleeve Online Sample Reports
32
General Care and Maintenance
Avoid extreme heat, cold, solvents, and oils.
The entire CardioSleeve device can be wiped clean with alcohol.
Remove the device from the stethoscope for thorough cleaning.
Note: Do not immerse your CardioSleeve device in any liquid or subject it to steam sterilization. If
disinfection is required, the device may be wiped with a 70% isopropyl alcohol solution.
Cleaning
CardioSleeve parts can be cleaned by wiping with dry cloth or by wiping with alcohol. Sensor and
grounding plate surfaces can be wiped with alcohol. Dry all parts and surfaces thoroughly before use.
Recording Quality
CardioSleeve diagnostic performance and accuracy relies on the quality of the heart sound
recording.
Before starting the auscultation recordings, make sure the acoustic heart sound is audible, with S1
and S2 clearly identifiable. If not, move the stethoscope head to a location of optimal heart sound
detection.
The patient must be quiet, calm and in a comfortable posture with minimum lung (pulmonary)
and bowl sounds.
When handling the stethoscope, motion artifacts must be minimized. The stethoscope should also
only touch the skin of the patient. Press the stethoscope head firmly against the chest of the
patient for adequate sound transfer. Prevent contact with clothes and the cabling of the system. To
minimize the rubbing noise, use lubrication gel.
The environment must be quiet and background noise limited to the minimum. Close doors to
neighboring room, switch off air-conditioners and fans or other possible noisy equipment. Instruct
all persons in the room to remain quiet for the duration of the recordings.
After finishing the recordings, verify that:
The S1 and S2 signals are visible within the recorded heart beats
There are no large visual and auditory spikes in the recorded signal
The indicated heart rate corresponds to your measurement
There's adequate recorded heart beats to analyze (> 20 beats recorded)
33
34
General Specifications
ECG
Leads ......................................................................................3 Leads
Input Dynamic Range.............................................................3.7V Peak to Peak
Recording Time.......................................................................Min. 10 sec, Max. 30 sec
Shelf Life..................................................................................Estimated 5 years
Controls...................................................................................Power On/Off, Recording, Sleep
ECG Implification....................................................................10X Gain
Circuitry
Frequency Response...............................................................20 HZ to 1000 HZ
Sampling Frequency................................................................2000Hz
Input Impedance.....................................................................>100 MOhm
Differential Range...................................................................+/-5 mV
Data Resolution.......................................................................>12 bit
Output
Communication.......................................................................Bluetooth 2.1+EDR
Batter “tatus……………………………………………………….................Battery Status on Device and application
“erial Nu er I di atio ………………………………………………........O De i e
Power Requirements
Battery Type.............................................................................1 Lithium Ion 3.7V 450mAh Rechargeable
Batter Life………………………………………………………………………………Appro i atel hours
Charger Po er “uppl ……………………………………………………………… VDC
Physical Characteristics
Dimensions...................................................................................75x50x25 mm
Weight..........................................................................................50 grams
ECG Material…………………………………………………………………………….“ili o Nitride
ECG Pro e “ize………………………………………………………………………….
Casi g Material…………………………………………………………………………“ili on Rubber, ABS Plastic, Stainless Steel
Environmental Specifications
Operational Temperature.............................................................5° C till 40° (41°F to 104°F)
Operational Humidity....................................................................10% to 95%
Standards Compliance
ISO 10993 IEC ‐ UL1642 ISO 14971 AAMI/IEC 60601-2-47
Patient Interface
Two silicon nitride electrodes and a stainless steel grounding pad are exposed around the head of an acoustic
stethoscope, placed o the patie t s hest..
User Interface
3 LEDs display battery life, Bluetooth communication and recording status.
Electrical Safety Specifications
35
45o C
10o C
95%
10%
Symbols used for Software, Hardware and Package Labeling
SN
REF
Warning
Caution
Manufacturer
DC Power Source
Type BF Applied Part
Consult User Manual
Temperature Limitation
European Conformity Mark
Humidification Limitation
Serial Number
Model Number
Latex Free LATEX
36
Warranty Information
Cardiosleeve is warranted against any defects in material and
workmanship for a period of two (2) years. If a material or
manufacturing defect is discovered during the warranty period, repairs
will be made without change upon the return of the device to Rijuven,
except in cases of obvious abuse or accidental damage.
Consult the End User License Agreement for additional warranty
information.
Contact Information
Contact Us
We appreciate your interest in Rijuven Products. For assistance,
please contact us at the following:
General Inquiries [email protected]
Medical Professionals [email protected]
Customer Service/ Technical Support [email protected]
Sales [email protected]
Phone
412.965.8104
Address
Rijuven Corporation
624 Whispering Pines Drive
Pittsburgh, Pennsylvania 15238
37
Number Location Icon/Button/Control Definition
1a Home Auscultation Perform Auscultation with ECG
1b Home 3 Lead ECG Perform 3 Lead ECG
1c Home Recorded Results View Previously Recorded Patient Results
1d Home Choose Patient All Select from list of all patients
1e Home Choose Patient New Select from list of new patients
1f Home Recent Patients Select from list of recent patients
1g Home Instant Exam Select from list of Instant Exam patients
2a Choose Patient All View list of all patients
2b Choose Patient New View list of new patients
2c Choose Patient Recent View list of recent patients
2d Choose Patient Exam view list of Instant Exam patients
3a HS Location Aortic Selection Select Aortic Location
3b HS Location Pulmonary Selection Select Pulmonary Location
3c HS Location Tricuspid Selection Select Tricuspid Location
3d HS Location Mitral Selection Select Mitral Location
3f HS Location Record Record at selected Location
3g HS Location Details View HS Details Screen
3y HS Location Info View auscultation technique
3h HS Recording Cancel Cancel Recording
3i HS Details Stop End Auscultation with ECG
3j HS Details Locations Toggle to Chest View
3k HS Details Aortic View Aortic Details
3l HS Details Pulmonary View Pulmonary Details
3m HS Details Tricuspid View Tricuspid Details
3n HS Details Mitral View Mitral Details
3o HS Details Chest Toggle to Chest View
3p HS Details View Tracings View recorded tracings
3q HS Details Patient Position Select patient position
3r HS Details RR Interval Caliper Caliper Measure RR Interval
3s HS Details PR Interval Caliper Caliper Measure PR Interval
3t HS Details QRS Interval Caliper Caliper Measure QRS Interval
3u HS Details QT Interval Caliper Caliper Measure QT Interval
3v HS Details Save Caliper Save Caliper Measurements
3w HS Details QTc Alert View QTc Interval Ranges
3x HS Details Interval Guide View Interval Measurement Guide
4a HS Details>> View Tracings Close Close view and revert to HS Details
4b HS Details>> View Tracings Lock Lock tracing for save
4c HS Details>> View Tracings Play Play auscultation with ECG tracing
4d HS Details>> View Tracings Pause Pause auscultation with ECG tracing
4e HS Details>> View Tracings speed Speed up playback of auscultation with ECG tracing
4f HS Details>> Patient Position Supine Select supine patient position
4g HS Details>> Patient Position Sitting Select sitting patient position
4h HS Details>> Patient Position Standing Select standing patient position
Appendix A- CardioSleeve Icons, Buttons and Controls
38
4i HS Details>> Caliper Cancel Cancel caliper measure
4j HS Details>> Caliper Done Save caliper measurement
5a ECG Location Lead 1 Selection Select Lead 1 location
5b ECG Location Lead 2 Selection Select Lead 2 location
5c ECG Location Lead 3 Selection Select Lead 3 location
5d ECG Location Record Record at selected Lead
5f ECG Location Details View HS Details Screen
5g ECG Location Info View ECG Technique
5h ECG Recording Cancel Cancel Recording
5i ECG Details Stop End 3 Lead ECG
5j ECG Details Leads Toggle to chest view
5k ECG Details Lead 1 Select Lead 1 details
5l ECG Details Lead 2 Select Lead 2 details
5m ECG Details Lead 3 Select Lead 3 details
5n ECG Details Chest Toggle to chest view
5o ECG Details View Tracings View selected Lead tracings
5p ECG Details View Multiple Tracings View all recorded Lead tracings
5q ECG Details RR Interval Caliper Caliper Measure RR Interval
5r ECG Details PR Interval Caliper Caliper Measure PR Interval
5s ECG Details QRS Interval Caliper Caliper Measure QRS Interval
5t ECG Details QT Interval Caliper Caliper Measure QT Interval
5u ECG Details Save Caliper Save Caliper Measurements
5v ECG Details QTc Alert View QTc Interval Ranges
5w ECG Details Interval Guide View Interval Measurement Guide
6a ECG Details>> View Tracings Close Close view and revert to HS Details
6b ECG Details>> View Tracings Lock Lock tracing for save
6c ECG Details>> Caliper Cancel Cancel caliper measure
6d ECG Details>> Caliper Done Save caliper measurement
7a Recorded Results Choose Patient View list of patients
7b Recorded Results Trends View selected patient trends
7c Recorded Results Auscultation Exam View selected historic auscultation
7d Recorded Results ECG Exam View selected historic ECG
7e Recorded Results>> ECG Exam>> ECG Historic Compare with last two historic exams Compare last two historic exams
8a Cardiac Index (CI) Parameters Stop Cancel Cardiac Index calculation
8b Cardiac Index (CI) Parameters Calculate Calculate Cardiac Index
8c Cardiac Index (CI) Parameters>> CI Estimate CI Parameters Revert to Cardiac Index Parameters screen
8d Cardiac Index (CI) Parameters>> CI Estimate Save Save Cardiac Index
9a Settings Defaults Default software settings
9b Settings User Details Registered user settings
9c Settings Paired Devices Display paired devices information
9d Settings User Manual Display user manual
9e Settings>> Defaults Graph Orientation Choose default tracing orientation
9f Settings>> Defaults Default Posture Choose default posture
9g Settings>> Defaults Recording Duration Choose default recording duration
9h Settings>> User Details User Information Read and review user information
9i Settings>> User Details PIN Change PIN
9j Settings>> User Details Password Change password
39