VENTRIJECT Seismofit Electromagnetic Emission System Instruction Manual
- June 13, 2024
- VENTRIJECT
Table of Contents
Seismofit®
Instructions for use
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®.
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® are registered tradenames owned by the company and Seismofit® .
VentriJect ApS
Ryvangs Alle 81-83
2900 Hellerup
Denmark
www.VentriJect.com
Electromagnetic Emission
Electromagnetic Immunity
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.
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 equipment for recording of 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 ® Patch and is
operated with the VentriJect Clinical ® Sensor and the Seismofit®.
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.
Intended use
The Intended use of Seismofit is to determine a VO2max-score equivalent based
on seismocardiography to assess patient 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 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 based on 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 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 used in medical clinics or equivalent at room
temperatures, atmospheric pressure range of 700hPa to 1060hPa.
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.
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.
Symbols
| Symbol | Explanation |
|---|---|
| Product code | |
| 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
| The Seismofit® Sensor must at discarding be delivered for recycling
according to national law. (Directive 2012/19/EU, (WEEE)
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 CRFscore may be disturbed unintended.
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.
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 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) is 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.
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 copacked with the Seismofit® Sensor shall be placed in the tray
(orientation of the positive battery terminal is marked in the tray) which
currently is closed. 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
The steps are
- Mounting the adhesive patch
- Position of the sensor at the distal (lowest) third part of the sternum withhead drawing against the head of the test person
- Input weight, height, age, and sex
- Start of recording
- Analyzing step
- Read out of result
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 against the head of the
test person.
Preparing a test person
To ensure a high quality of the recorded signal presence of hair must be
removed from the skin at the sternum if it is considered to interfere with the
intimate contact between the sensor and skin.
An ordinary electric razor machine is recommended.
A patch shall never be applied to broken skin.
Performing a recording
After opening the VentriJect Clinical App following steps are presented
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
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.
Screen
6-8 Initiation of recording and transferring of the data from the Seismofit®
Sensor to the smartphone. Screen 9-10 Analyzing and showing final VO2max
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.
Maintenance
Seismofit Sensor does not hold any parts that require service. If expired the
battery must be changed.
The Seismofit® Sensor requires no calibration.
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® Sensor and Patches respect the EU Directive 2012/19/EU regarding
the discarding of ® and the distributors of Seismofit® electronic equipment
(WEEE).
Seismofit® Sensor requirements
Functionality:
Temperature 10-40°C.
Relative humidity 20-80% without condensate
Storage
Temperature 10-40°C.
Relative humidity 20-80% without condensate
Recording conditions
Pulse < 90 bpm
Power supply
Battery 3V like Maxell CR2032
Seismofit ® smartphone requirements
Apple iOS 13.3 or newer.
Android 10 or newer.
Warranty
The Seismofit Sensor is covered by a warranty of a one-year use from the day
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 house parts
have been taken apart.
The warranty does not cover the interpretation of results outside of indicated
use.
Approvals
| IEC 60601 | Compliance to IEC 60601-1 |
|---|---|
| CE-mark | Compliance to Medical Device Directive 93/42/EEC |
| EMC-emission | Compliance to the requirements in EMC emission Class B devices |
in EN 606011-2
EMC-immunity| Compliance to immunity requirements of EN60601-1-2:
Acronyms & Definitions in text
| Akronyms | Definitions |
|---|---|
| Seismocardiography | Recording and interpretations of vibrations originating |
from the beating heart
Seismofie System| Sensor, and Patch.
Seismofie| Sensor that records vibrations from the heart
Seismofie Patch| Adhesive patch for fixation of sensor to the skin at the
chest
VO2max-score / Seismofie Score| Cardiorespiratory fitness score — a measure of
health
Recording| Obtaining a seismogram from the heart
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.
The Seismofit® can be used in electromagnetic environments as described in the
table below:
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.
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.
Recommended separation distance
d = 1.2√P for 80 MHz to 800 MHz
d = 2.3√P 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.
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.
Version 3
Revision 20.01.2023
Documents / Resources
|
VENTRIJECT Seismofit Electromagnetic Emission
System
[pdf] Instruction Manual
Seismofit, Seismofit Electromagnetic Emission System, Electromagnetic Emission
System, Emission System, System
---|---
References
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