VentriJect VO2 Accurate Max Estimation Instruction Manual
- September 12, 2024
- VENTRIJECT
Table of Contents
VO2 Accurate Max Estimation
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Specifications:
- Product Name: VentriJect
- Manufacturer: VentriJect ApS
- Country of Origin: Denmark
- Website: www.ventriject.com
Product Description:
The VentriJect is a seismocardiographic recording device that
transmits recordings to a smartphone for analysis. The smartphone
communicates with a cloud server to calculate an equivalent to the
CRF-score (estimated VO2max) displayed in the Clinical App.
Intended Use:
-
The device is intended for seismocardiographic recordings for
health monitoring purposes. -
The recordings are transmitted to a smartphone for further
analysis.
Instructions for Use:
First Recording:
-
Install the VentriJect App on your smartphone following the
purchase instructions. -
Mount the adhesive patch on the distal third part of the
sternum with the sensor placed towards the head of the test
person. -
Input weight, height, age, and sex into the app.
-
Start the recording.
-
Follow the analyzing steps provided by the app.
-
Read the result displayed in the Clinical App.
Maintenance:
After each use, clean the device using tissue moistened with
water or an ethanol wiper. Ensure that the outer plastic shell is
not damaged or broken. Do not modify the device in any way.
Requirements Functionality:
-
Ensure proper storage conditions as specified in the user
manual. -
Adhere to the recommended recording conditions for accurate
results. -
Use the specified power supply to operate the device.
FAQ:
Q: What should I do if the device’s outer plastic shell is
damaged?
A: Do not use the device if the outer plastic shell is damaged
or broken. Contact customer support for assistance.
Q: Can I reuse the adhesive patch?
A: The adhesive patch is for single use only. Do not reuse it
for subsequent recordings.
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Seismofit® Instructions for use
1
Version 4.2
Disclaimer The information in the instructions for use is addressing an
international market for health services and is based on text, illustrations,
and symbols. The Instruction for Use gives no specific references to religion,
ethnicity, gender, or policy. Any such relationship must be considered as an
interpretation that VentriJect® cannot be responsible for. The information is
only intended for achieving a secure and exact use of the Seismofit®.
Copyright The content of the Instruction for Use must not be reproduced for
third parties without written consent from VentriJect®.
2
Changes The Instruction for Use may be updated without warning. The user may
find the Instruction for Use for any version of the Seismofit® at the
VentriJect® website from where it may be downloaded.
The illustrations may deviate from the actual equipment which reflects the
constant work for improving the product.
Brand name VentriJect® and Seismofit® are registered trade names owned by the
company.
VentriJect ApS Ryvangs Alle 81-83 2900 Hellerup Denmark www.ventriject.com
Version 4.2
Table of contents
Disclaimer
p 2
Copyright
Changes
Brand name
Introduction
p 4
Instructions for Use (IFU)
The Seismofit® and the environment
Product Description
Intended use
p 5
Use of the recording
Risks
Intended user profile
Intended test persons
Use conditions
Symbols
p 7
Definitions:
Symbols of the product and in the
Instruction for Use
Warnings
Precautions
Seismofit® Sensor
P 10
3
First recording
Start recording
Seismofit® Patch
Preparing a test person
Performing a recording
After the recording
Lost Connection to Seismofit®
Maintenance
Discarding
p 18
Patch
Sensor
Requirements Functionality
p 18
Storage
Recording conditions
Power supply
System specifications
Warranty
p 19
Approvals
p 19
Acronyms & Definitions
p 20
EMC Information
p 21
Electromagnetic Emission
Electromagnetic Immunity
Version 4.1
Introduction
Instructions for Use (IFU) This instruction for use is intended as a reference
guide for the safe and correct use of Seismofit®.
The IFU contains both general and specific instructions for use including the
seismocardiographic recording, maintenance, and information on specific
components.
To ensure optimal use of the Seismofit® it is important to read the IFU
carefully and understand the use of the product before starting.
Seismofit® and the environment. Seismofit® is designed and sized to minimize
the impact on the environment.
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The sensor is small with wireless communication, the adhesive patch is
similarly of minimal size, and the outer packaging is made from cardboard that
may be discarded as ordinary paper waste.
Seismofit® contains microelectronic components and must not be discarded as
ordinary waste but be delivered for recycling.
Product Description The Seismofit® Sensor is an equipment for recording
vibrations of the chest of a person.
Seismofit® records the vibrations arising from the heart on the person’s chest
and transmits the recording to the VentriJect App.
The Seismofit® System consists of two parts: a Seismofit® Sensor and a
Seismofit® Patch and is operated with the VentriJect Clinical
Version 4.1
App. The patch is for adhering the sensor to the chest when positioned at the
sternum. The Seismofit® Sensor is shown in the picture below.
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Intended use
The Intended use of Seismofit® is to determine a VO2max-score equivalent based
on seismocardiography to assess subject health and vitality status.
Use of the recording The recording will be transmitted to a smartphone for
further examination.
The smartphone will communicate with a cloud server that will analyze the
recording and calculate an equivalent to the CRF-score (estimated VO2max)
which will be displayed in the Clinical App.
Risks By use of Seismofit®, a VO2max-score equivalent will be created. If
using this for strategies concerning health issues it should
Version 4.1
be done together with a professional like medical doctors, physiologists,
therapists, or technicians. Using the Seismofit® outside of its intended use
or not following the guidelines for correct recording, described in this
document, can result in estimations of unintended higher or lower VO2max-score
for the subject.
The Seismofit® will not be able to cause any hazards. The battery is low
power, the Bluetooth® connection is low power and any emission will be much
weaker than emissions from a smartphone. The patch is made of skin-friendly
and nonsensitizing adhesive.
Intended user profile Seismofit® is intended for use with health care
professionals like medical doctors, nurses, technicians, therapists, and
coaches
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after having read the IFU or being instructed in the system but not limited
thereto.
Intended test persons Seismofit® is intended to be used for adult persons of
both genders above 18 years of age and without electronic implants.
Use conditions Seismofit® is intended to be used in medical clinics or
equivalent at room temperatures and atmospheric pressure range of 700 hPa to
1060 hPa.
Do not sterilize, autoclave, or wash the Seismofit® Sensor. Do not record in a
noisy environment where vibrations could be expected or with strong
electromagnetic fields or radio frequency from machines or equipment.
Version 4.1
Warning: Use of the Seismofit® Sensor adjacent to or stacked with other
equipment should be avoided because it may result in improper operation. If
such use is necessary, the Seismofit® and the other equipment should be
observed to verify that they are operating normally.
Warning: Portable RF communications equipment (including peripherals such as
antenna cables and external antennas) should be used no closer than 30 cm (12
inches) to any part of the Seismofit®. Otherwise, degradation of the
performance of this equipment could result.
Remove hair before recording if disturbing the fixation.
Only use tissue moistened with water or an ethanol wiper for cleaning.
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Symbols
Symbol
Explanation Medical device
Series number
Warning and precautions Notice the description below
Guidance for help in the Instruction for Use
Label for compliance with relevant EU-directives.
Batch code
Producer
Version 4.1
The Seismofit® Sensor must at discarding be delivered for recycling according
to national law. (Directive 2012/19/EU, (WEEE) Limit for temperature
Limit for humidity
Limit for atmospheric pressure
Use before
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Type BF applied part Do not reuse
Version 4.1
Definitions: The Instruction for Use contains symbols and user information
that are important and must be read carefully before the recording is started.
Symbols and warnings will also be found on the packaging for the Seismofit®
Sensor and the Seismofit® Patches.
Symbols of products and in the Instructions for Use. Warnings: describe
situations where the VO2max-score may be disturbed.
Precautions: describe situations where the functionality of the Seismofit®
Sensor may interfere.
Warnings Deviation of procedures from the IFU or use of the Seismofit® outside
the intended field of use may result in errors and misinterpretations for the
patient.
Do not use the Seismofit® on patients with implanted electronic equipment like
pacemakers or equivalent as scores may be incorrect.
Do not use Seismofit® on very hairy skin, scars after surgery, or abnormal
body shapes that lead to poor fixation of the product as this may lead to
wrong scores.
Do not use the Seismofit® Sensor without the original Seismofit® Patch as this
may lead to misleading scores.
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Version 4.1
Do not apply liquids (water, oils, solvents, surfactants, or the like) to the
Seismofit® Sensor as it may cause functional errors.
Do not use the device if the outer plastic shell is damaged or broken,
exposing the internal components of the device.
Do not modify the device in any way.
Precautions Avoid dropping or violent handling of the Seismofit® Sensor as
this may cause damage to the microelectronic part including the accelerometer
and Bluetooth® transmission.
Apply correct cleansing of the Seismofit® Sensor.
Store and apply the Seismofit® Sensor and Patch according to claims in the
Instruction
10
for Use concerning temperature and humidity.
Seismofit® Sensor
The Seismofit® Sensor records the vibrations of the chest originating from the
heart and recorded at the sternum. The recorded signal will be transmitted to
a smartphone. The sensor has direct physical contact with the skin via an
adhesive patch.
The test person must rest on the back (supine position) and the sternum (lower
third of chest bony prominence) must be localized. The Seismofit® Sensor must
be used together with the Seismofit® Patch for firm contact with the chest
ensuring the best recording. If a patch is placed wrongly, a new one shall be
used. The patch is for single use only.
Version 4.1
The test person must not have an elevated pulse. If blood pressure is
determined, it will be optimal to make the VO2max estimation afterward.
First recording A prerequisite for the first recording is installing the
VentriJect App on your smartphone according to purchase instructions.
Before starting the first recording, the battery tray shall be opened and the
battery co-packed with the Seismofit® Sensor shall be placed in the tray
(orientation of the positive battery terminal is marked in the tray). Close
the battery tray.
Now the sensor is active (photo: open tray).
Start Recording The overall investigation time will be a few minutes. The
following guide describes the major steps when using the Seismofit® Sensor and
VentriJect Clinical App to perform a recording.
The VentriJect Clinical App can be downloaded via www.ventriject.com/app
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Version 4.1
The steps are A. Mounting the adhesive patch B. Position of the sensor at the
distal (lowest) third part of the sternum with head drawing towards the head
of the test person C. Input weight, height, age, and sex D. Start of recording
E. Analyzing step F. Read out of result
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Version 4.1
Seismofit® Patch The Seismofit® Patch is supplied in boxes containing 20
pieces. The patches are disposable and can be discarded together with ordinary
plastic or laminated packaging.
The patch has a liner with adhesive on both sides as a core with silicone
release papers on top. In use, the patch shall first have removed the small
release paper (no print) and be applied to the sensor’s bottom surface. Next,
the first part followed by the second part of the second release paper is
removed and the combined sensor and patch are applied to the skin of the lower
third part of the chest with the correct orientation towards the head of the
test person.
Preparing a test person To ensure a high quality of the recorded signal, the
presence of hair must be removed
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from the skin at the sternum, if it is considered to interfere with the proper
contact between the sensor and the skin. An ordinary electric razor machine is
recommended. A patch shall never be applied to broken skin.
Version 4.1
Performing a recording After opening the VentriJect Clinical App, the following steps are presented.
Screen 1
Screen 2
Screen 1: select and choose the Seismofit® Sensor by its ID. Screen 2: recall the latest test result, by clicking on the blue information icon. The operator can request an email, containing the result of the analysis.
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Screen 3
Screen 4
Screen 5
Screen 3-5 Approving device (in case more devices are contactable), positioning at chest, and entering of information.
Screen 3 allows for analysis of a recording stored on the device. This is only pertinent if the App has been disconnected from the Seismofit® Sensor during a previously ongoing recording.
Version 4.1
Screen 6
Screen 7
Screen 8
Screen 6-8 Initiation of recording and transferring of the data from the Seismofit® Sensor to the smartphone.
Screen 9
Screen 10
Screen 9-10 Analyzing and showing final VO2max. The operator can request an email, containing the result of the analysis.
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Version 4.1
After the recording Remove and discard the Seismofit® Patch and cleanse the
Seismofit® Sensor with a 70% ethanol cleaning tissue.
Never use running tap water for the cleansing of the Seismofit® Sensor.
If the Seismofit® Sensor by accident becomes wet, let it dry for 24 hours at
ambient temperature in low to medium humidity air. Never use an electric oven
or hairdryer.
Lost Connection to Seismofit® In the case of a lost connection to the
Seismofit® that does not automatically reconnect to the app, close the App
completely on the smartphone and open it again.
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Error Messages In case an error occurs during the analysis of the recording,
an error message is displayed in the VentriJect Clinical App. The possible
error messages are:
· Heart rate out of bounds: If the heart rate is below 30 BPM or above 100
BPM.
· Internal algorithm error: Errors in the algorithm not described by the other
error messages in this list.
· No heartbeat signal detected: A signal of sufficient quality for analysis
could not be detected. This error can also be caused by the recording being
too short.
· No heart rate detected: It was not possible to detect a stable heart rate in
the recording.
Version 4.1
· Signal too noisy: The signal is too noisy to analyse, e.g. due to movements
or poor contact between the patch and the skin.
· Subject not in supine position: The subject was not resting on the back
(supine position) during the recording.
In case any of these error messages occurs, the VO2max could not be estimated
and it is therefore recommended to perform a new recording.
Maintenance Seismofit® Sensor does not hold any parts that require service. If
expired, the battery must be changed.
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The Seismofit® Sensor requires no calibration.
Version 4.1
Discarding
Patch The Seismofit® Patch may be discarded as ordinary trash.
Sensor When the Seismofit® Sensor is worn out, the discarding must be done by
the recycling station according to national regulations.
Seismofit® and the distributors of Seismofit® Sensor and Patches must respect
the EU Directive 2012/19/EU regarding the discarding of electronic equipment
(WEEE).
Seismofit® Sensor requirements
Functionality: Temperature 10-40°C. Relative humidity 20-80% without
condensate
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Storage Temperature 10-40°C. Relative humidity 20-80% without condensate
Recording conditions Pulse < 100 bpm Power supply Battery 3V like Maxell
CR2032 System specifications Apple iOS 13.3 or newer. Android 10 or newer.
Version 4.1
Warranty
The Seismofit® Sensor is covered by a oneyear warranty from the date of
purchase.
The Seismofit® Patch has an expiration period of 2 years from the
manufacturing date.
The warranty is not valid in case of misuse or if Seismofit® Sensor housing
parts have been taken apart. The warranty does not cover the interpretation of
results outside of indicated use.
Approvals IEC 60601 CE-mark EMC-emission
EMC-immunity
Compliance to IEC 60601-1 Compliance to Medical Device Directive 93/42/EEC Compliance to the requirements in EMC emission Class B devices in EN 606011-2 Compliance to immunity requirements of EN60601-1-2:
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Version 4.1
Acronyms & Definitions in text
Akronyms Seismocardiography
Seismofit® System Seismofit®
Seismofit® Patch
VO2max-score / Seismofit® Score Recording
Definitions Recording and interpretations of vibrations originating from the beating heart Sensor and Patch. Sensor that records vibrations from the heart Adhesive patch for fixation of sensor to the skin at the chest Cardiorespiratory fitness score a measure of health Obtaining a seismogram from the heart
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Version 4.1
EMC Information
Electromagnetic Emission
Technology: Wireless Bluetooth Low Energy (BLE) Modulation type: Gaussian
frequency shift keying (GFSK) modulation Frequency area: 2400 -2480 MHz
Radiated effect maximum: 2.5 mW (Class 2 transmitter) The radio equipment can
be used without safety distance to the user.
Emission Test RF Emission CISPR 11 Compliance Group 1 Class B Guidance Device
uses Radio Frequency 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.
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Version 4.2
Elektromagnetic Immunity
The Seismofit® can be used in electromagnetic environments as described in the
table below:
Immunity Test Electrostatic Discharge (IEC 61000-4-2) Compliance Contact
Discharge: ±8 kV Air Discharge: ±2 kV, ±4 kV, ±8 kV, ±15 kV
Guidance Floors should be wood, concrete or ceramic tile. If floors are
covered with synthetic material, the relative humidity should be at least 30%.
Immunity Test Radiated RF EM filed (IEC 61000-4-3) Compliance 80-2700 MHz;
1kHz AM 80 %; 3 V/m Guidance Portable and mobile RF communications equipment
should be used no closer to any part of the device, including cables, than the
recommended separation distance calculated from the equation applicable to the
frequency of the transmitter.
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Version 4.1
Recommended separation distance d = 1.2P for 80 MHz to 800 MHz
d = 2.3P for 800 MHz to 2,7 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).
Immunity Test Proximity fields form RF wireless communications equipment (IEC
61000-4-3) Compliance – 385 MHz; Pulse Modulation: 18 Hz; 27 V/m – 450 MHz, FM
- 5 Hz deviation: 1 kHz sine; 28 V/m – 710, 745, 780 MHz; Pulse Modulation:
217 Hz; 9 V/m – 810, 870, 930 MHz; Pulse Modulation: 18 Hz; 28 V/m – 1720,
1845, 1970 MHz; Pulse Modulation: 217 Hz; 28 V/m – 2450 MHz; Pulse Modulation:
217 Hz; 28 V/m; – 5240, 5500, 5785 MHz; Pulse Modulation: 217 Hz; 9 V/m
Guidance
Portable and mobile RF communications equipment should be used no closer to any part of the device, including cables, than the recommended separation distance 30 cm.
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Version 4.1
Immunity Test Rated power frequency magnetic fields (IEC 61000-4-8)
Compliance 30 A/m, 50 Hz: 217 Hz; 9 V/m Guidance Power frequency magnetic
fields should be at levels characteristic of a typical location in a typical
commercial or hospital environment.
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Version 4.1