MY01-000M Continuous Compartmental Pressure Monitor User Manual
- June 12, 2024
- MY01
Table of Contents
MY01-000M Continuous Compartmental Pressure Monitor
Product Information
Product Name: Continuous Compartmental Pressure Monitor
Model Number: MY01-000M
Version: 15
Manufacturer: CEpartner4U BV
Address: Esdoormlaan 13, 3951 DB Maarn, The Netherlands
Device Components: Introducer and Pressure Monitor
Intended Use: The Continuous Compartmental Pressure Monitor is
designed for safe and effective monitoring of compartmental
pressure in medical procedures.
Device Interface: The device is equipped with a lead-wire
display, push-button controls, and various display icons to provide
information about pressure trends.
Warnings and Notes: The user manual contains important safety
instructions and information that should be followed to ensure
patient and user safety.
Specifications: The device has specific temperature, humidity,
and pressure limits. It is sterilized using ethylene oxide and
should not be resterilized. The device is for single patient-use
only.
Environmental Conditions: The device should be kept away from
sunlight and magnetic resonance imaging (MRI) equipment. It
complies with Ingress Protection (IP) rating IP53.
Reorder Information: The user manual provides reorder
information including batch code and catalogue number.
Product Usage Instructions
-
Read the user manual carefully before operating the
device. -
Ensure that the device package is not damaged before use. Do
not use if the package is damaged. -
Only use the device on a single patient. It is not intended for
multiple uses. -
Follow the user and patient safety precautions mentioned in the
manual. -
Connect the introducer and pressure monitor components of the
device. -
Use the lead-wire display and push-button controls to navigate
the device interface. -
Pay attention to the display icons, especially the trend
arrows, which indicate pressure changes. The arrows signify a
decrease or increase in pressure, with different thresholds. -
Keep the device within the specified temperature, humidity, and
pressure limits. -
Avoid exposing the device to sunlight and magnetic resonance
imaging (MRI) equipment. -
Dispose of the device after use according to the appropriate
medical waste disposal guidelines.
USER MANUAL
REF: MY01-000M Version 15
Continuous Compartmental Pressure Monitor
MY01 Inc. 400 Boul de Maisonneuve Ouest, Suite 700, Montréal, QC H3A 1L4 +1 855-799-6901
ONLY
CEpartner4U BV Esdoormlaan 13 3951 DB Maarn The Netherlands
TABLE OF CONTENTS
Symbol Explanation ……………………………………………………………… 3
Introduction………………………………………………………………………….. 5
Warnings and Notes…………………………………………………………………………. 5 Intended
Use……………………………………………………………………………………. 5
User & Patient Safety Precautions ………………………………………………. 6
Components…………………………………………………………………………. 7 Device
Interface……………………………………………………………………. 8 Wireless Connection
……………………………………………………………10 Operational Instructions………………………………………………………18
Troubleshooting ………………………………………………………………….25
Device Interface Error Codes ………………………………………………………….. 25 Instrument Defects or
Product Deficiencies ……………………………………. 26
Specifications ……………………………………………………………………… 27
Device ……………………………………………………………………………………………. 27 Environmental Conditions
………………………………………………………………. 28 Electromagnetic Compatibility
……………………………………………………….. 29
Reorder Information…………………………………………………………….32
Symbol Explanation
Caution
Read instructions for use before operating the device
Caution : Federal law (USA) restricts this device to sale by or on the order
of a physician
Sterilized using ethylene oxide
STERILE EO
Type BF applied part
Do not resterilize
STERILIZE
Do not use if package is damaged
Single patient-use device
Manufacturer
Maximum and minimum temperature limits
Maximum and minimum relative humidity limits
Maximum and minimum pressure limits
Keep away from sunlight
Use-by date
Batch code
Catalogue number
Authorized representative in the European Community
Ingress Protection (IP Rating) Signifies European technical conformity
IP53
Keep away from magnetic resonance imaging (MRI) equipment
Importer
Indicates the authorized representative in Switzerland
CH REP
3
DEVICE INTERFACE SYMBOLS
Bluetooth Full battery Warning: low battery level Trend arrows
4
Introduction
WARNINGS AND NOTES
The instructions for use manual provides information to ensure safe and
effective use of the product. The following terminology is used:
WARNING: The personal safety of the patient may be involved. Disregarding this
information could result in injury to the patient and/or user. NOTE: This
provides additional important information the user should be aware of.
INTENDED USE
The MY01 Continuous Compartmental Pressure Monitor is intended for real-time
and continuous measurement of compartmental pressures. The measured
compartmental pressures can be used as an aid in the diagnosis of compartment
syndrome. The trend arrows displayed are meant for qualitative purposes only
and are not intended to have any clinical significance. The MY01 Mobile
Application is an optional application intended for storing and displaying
identical pressure values from the MY01 Continuous Compartmental Pressure
Monitor device. The data is for informational purposes only and is not
intended to be used for diagnosis of any nature or active patient monitoring.
5
User & Patient Safety Precautions
WARNING
· The device should only be used in a healthcare facility environment by
medical professionals who have received the appropriate training.
· Do not perform a diagnosis solely based on pressure measurements of the
device. Always use the device with the current standard of care.
· Use aseptic practices during usage – follow healthcare facility guidelines.
· Do not ship, store or use the device outside the specified environmental
conditions (See Table 4). · Single-use device, do not reuse. Patient safety
may be compromised. · Do not use the device past the expiration date. · Do not
resterilize the device. It is initially ETO sterilized and cannot be
reprocessed. · Do not clean the device. · Do not perform any maintenance on
the device. · Do not use the same device in multiple patients. · Do not use
the device in proximity to MRI equipment and high frequency surgical
equipment. · Do not use the device if it is believed to be faulty. The user
should exercise clinical judgment when
performing measurements. · Do not dispose of dispenser packaging until all
devices are used.
CONTRAINDICATIONS No known contraindications
6
COMPONENTS
Packaging and Device
Figure 1: Packaged MY01 Device
The MY01 Continuous Compartmental Pressure Monitor comprises the following 2
major components: the Introducer and the Pressure Monitor.
Needle
Device Body
Sensor
Housing
Figure 2: Introducer
Lead-Wire Display Push-Button
Figure 3: Pressure Monitor (Applied Part)
7
Device Interface
Figure 4: Device Controls and Display Icons
Significance of trend arrows
The decrease in pressure is greater than or equal to 0.5 mmHg/hour. The
decrease in pressure is greater than or equal to 2 mmHg/hour. The increase in
pressure is greater than or equal to 0.5 mmHg/hour. The increase in pressure
is greater than or equal to 2 mmHg/hour.
8
WARNING · Trend arrows are meant for qualitative purposes only and are not
clinically significant. Do
not use trend arrows for diagnostic purposes. Always use pressure measurements
and clinical judgment along with the current standard of care.
Figure 5: Rotating Display Orientation
9
Wireless Connection
BLUETOOTH SPECIFICATIONS
The MY01 device transmits identical pressure readings collected over time to the MY01 Mobile Application using an authenticated BLE link. The MY01 device uses Bluetooth Low Energy (BLE) technology specification 4.2. Ensure that the mobile phone uses BLE-compatible wireless technology.
Table 1: BLE Specifications
Wireless technology version BLE specification 4.2
Frequency
2.4GHz
RF frequencies bandwidth
2.402GHz 2.4835GHz
RF radiated output power
0dBm, 1mWatts
Modulation type Bluetooth Interface Security
Gaussian Frequency Shift Keying (GFSK)
Authenticated LE Secure Connections pairing uses Numeric Comparison with P-256
ECDH.
Application layer Device-Application authentication using AES encryption
APPLICATION DESCRIPTION
The MY01 Mobile Application is an optional application intended for storing and displaying identical pressure values from the MY01 Continuous Compartmental Pressure Monitor device. The data is for informational purposes only and is not intended to be used for diagnosis of any nature or active patient monitoring. The MY01 Mobile Application does not control the MY01 Continuous Compartmental Pressure Monitor in any way.
10
APPLICATION FEATURES
The MY01 Mobile Application only allows users with valid login credentials to
access the software application. The MY01 Mobile Application home screen
displays a list of MY01 devices by device unique identifier. The user can
securely connect to a device via BLE by tapping on the device unique
identifier. Once securely connected, the pressure data points are sent over an
encrypted BLE link from the MY01 device. The MY01 Mobile Application displays
the latest pressure data point as a duplicate display (Figure 9). The full
pressure log can also be seen as a graph (Figure 10). Pressure data points are
forwarded via an encrypted network link to a Cloudbased service (MY01
Application Server) for archival purposes. The data stored by the MY01 Mobile
Application can be later retrieved.
Figure 6: Device Interface
11
APPLICATION DOWNLOAD
CONNECTING TO THE MY01 DEVICE
Open the MY01 Mobile Application and pull down to scan for nearby advertising
MY01 devices. Each entry in the list contains the unique MY01 Device
identifier. Verify that the unique identifier displayed on the application
matches the one displayed on the MY01 device’s LCD top-left corner.
10:40
LTE
10:40
LTE
Figure 7: Refreshing the Device list
12
Tap on a device entry to connect to the MY01 device. If connecting for the first time, a Bluetooth pairing request will appear. Confirm that the pairing PIN displayed on the application matches the pairing PIN displayed on the MY01 device’s LCD. Click on the “Pair” button to confirm and connect.
Figure 8: Pairing the Device Once connected to a MY01 device, a Bluetooth mark will appear next to the MY01 device unique identifier. Pressure data transmission will begin shortly after connection.
10:40
LTE
Figure 9 : Device Connected
13
ACTIVE DEVICE INFORMATION & DATA DISPLAY
Once the MY01 device has been successfully connected to the MY01 Mobile
Application the graphing function can be accessed by pressing on the Device of
choice section of the interface.
Figure 10: Data Display
14
Time elapsed since Pressure data was last updated
Less than 5 minutes Between 5 and 10 minutes More than 10 minutes Device is not currently in use
DISCONNECTING FROM THE MY01 DEVICE
To disconnect from a MY01 device, slide the Device entry to the left and click
on the “Disconnect” button.
10:40
LTE
Figure 11: Disconnecting
15
Operational Instructions
Step 1 : Peel the Tyvek lid where indicated. Lift the top cover and remove the
device from the
packaging. While holding the Introducer (see Figure 12), remove Needle Cap
before turning on the device
WARNING · Do not use the device if the Sensor is found unhooked from the
Needle after opening the pack-
age. Never attempt to re-assemble the device. · Do not use the device if the
integrity of the packaging is compromised. (See Page 24)
Step 2 : Activate the Pressure Monitor by pressing HARD and holding the Push-
Button until the
MY01 logo appears. The Display will subsequently show the MY01 logo and a
pressure value of 0.
NOTE · Avoid short presses on the push-button prior to turning on the Device.
· Make sure to not touch the sensor tip while turning on the Device.
Press Push-Button to power ON
Display illuminates
Cap
Figure 12: Removing Needle Cap and Turning ON the Pressure Monitor
16
WARNING · Always turn ON device BEFORE introducing into patient. · Do not use
the device if pressure measurements are not within -2.5 to 2.5 mmHg prior to
inser-
tion.
A
B
C
Figure 13: Recommended Device Grips
Step 3 : Without applying excessive force on the Display, insert the Needle
gently into the muscle
compartment in a controlled linear motion. Markings on the Needle should be
used to estimate the depth of the insertion.
NOTE
Figure 14: Introducing the Device
· The Display can be rotated to the desired orientation to ensure visibility during the insertion
(see Figure 5).
· Single marks are spaced along the needle at 1 cm intervals with the first located 2 cm from the
Needle tip. Double marks are placed at 5 cm intervals as measured from the Needle tip. · Consider applying local anesthetic before insertion. Ensure there are no allergies to anesthetic
use.
17
· The Introducer can be retracted and re-inserted (up to 5 total insertions)
to perform additional single-point measurements without ejecting the Pressure
Monitor.
WARNING · Always keep the Pressure Vent on the bottom-right of the screen
unobstructed (see Figure 4). · Do not use the device if the Sensor unhooks
unexpectedly after removing the Needle Cap or at
any point during the insertion (up to 5 single-point insertions). Never
attempt to re-assemble the device. · Do not rotate the Introducer during
insertion to prevent premature Sensor unhooking.
Step 4 : When the Sensor is in the desired position and readings have
stabilized, eject the
Pressure Monitor from the Introducer by pressing gently through the back
opening of the Introducer. An adhesive strip will be exposed on the back of
the Device Body when ejected.
A
B
Figure 15: Ejecting the Pressure Monitor
18
Step 5 : While holding the Introducer in one hand, use the other hand to
adhere the Device Body
to the patient’s skin using the exposed adhesive strip on the back of the
Device Body. Position the Device Body face-up on the patient’s skin near the
insertion point, ensuring sufficient slack in the Lead-Wire. The Lead-Wire
should extend straight out from the insertion site indicating the insertion
angle of the Sensor.
A
B
Figure 16: Placing the Device Body on Patient Skin
NOTE · Care should be taken when moving the Device Body to not pull the Lead-
Wire which can displace
the Sensor within the muscle compartment. · The Device Body should be
installed in a location which won’t interfere with adhesion during the
monitoring period. · It is recommended to prepare the skin appropriately to
improve adhesion, especially on hairy or
oily skin.
WARNING · If the adhesive strip is not exposed after ejecting the Pressure
Monitor from the Introducer (see
Figure 15), manually remove the protective liner. Do not re-apply the
adhesive. Additional medical tape should be used if the location of the Device
Body is changed after the first application. Ensure that the Pressure Vent
(see Figure 5) is not covered by the medical tape.
19
Step 6 : Disengage the Sensor by rotating the Introducer by 180 degrees.
Slowly remove the
Introducer from the patient and dispose of it in a biohazard-sharps
receptacle, as per facility guidelines.
NOTE · It is recommended to apply a dressing to the insertion site to fix the
Lead-Wire in place.
WARNING · Sharps biohazard – dispose as per facility guidelines and/or local
regulations.
Dressing
A
B
C
Figure 17: Removing the Introducer
Step 7 : Monitor pressure readings for a period of up to 18 hours. The
Pressure Monitor should
be routinely checked to ensure that it is secured to the patient throughout
the monitoring period and that the Lead-Wire does not pull on the Sensor and
displace it.
WARNING · Do not leave the Sensor inside the patient for a period longer than 18 hours.
20
Step 8 : When monitoring is complete, remove the dressing and gently pull on
the Lead-Wire by
hand to remove the Sensor from the patient. Dispose the Pressure Monitor in a
biohazard container, as per facility guidelines. NOTE · The Lead-Wire should
be pulled out at the same angle used for insertion of the Sensor to
minimize removal forces. WARNING
· The device is for single patient-use only. Do not attempt to reassemble the
device or replace the batteries after use.
· The device is single-use, do not reuse on the same patient. Patient safety
may be compromised. · Take necessary precautions while using the device
intraoperatively (e.g. fasciotomy, amputation,
debridement, skin graft).
21
A
B
C
D
E
F
Dressing
G
H
I
Figure 18: Insertion Procedure Summary
22
Troubleshooting
DEVICE INTERFACE ERROR CODES
Table 2: Error Code List
ERROR CODE
ERROR NAME
DESCRIPTION
ACTION
NON-CRITICAL ERRORS
Device operation is not
3
Lifetime Exceeded
Device has been running for longer than intended operating time
recommended beyond this time, if device is currently being used cease
operations immediately
4
Outside Operating Pressure Range
The absolute pressure reading from sensors is outside operating pressure range
Disregard the pressure values while error sign is visible
CRITICAL ERRORS
ERR 10
Sensor Integrity Compromised
ERR 11 Software Error
System has detected a critical malfunction in the sensing element
Software malfunction
DO NOT use the device. Call customer support for instructions on how to return
the device
DO NOT use the device. Call customer support for instructions on how to return
the device
23
Figure 19: Error Code Display
INSTRUMENT DEFECTS OR PRODUCT DEFICIENCIES
· For defective device concerns, or any related quality issues, please contact
[email protected] or call +1 855-292-6901.
· A MY01 representative will deal with any quality issues related to hardware,
software, or wireless functionality in a timely manner.
· Additional paper User Manuals can be made available upon request, free of
charge. To request one, please email [email protected] or call +1
855-799-6901.
24
Specifications
DEVICE
Table 3: Device Specifications
Model
MY01-0001
Pressure range
-99.9 to 99.9 mmHg
Power Display resolution Battery life IP Rating Weight Dimensions Needle gauge
Two (2) 3 V batteries (non replaceable) 0.1 mmHg 18 hours IP53 85 g (+/- 5g) 20 cm x 6.5 cm x 3 cm (+/- 1cm) 17-gauge
25
ENVIRONMENTAL CONDITIONS
Table 4: Environmental Conditions
Operation
Storage Transportation
40
Temperature
23
40 10
55 -20
Humidity
75%
75%
75%
30%
10%
10%
Pressure
106 kPa
106 kPa
106 kPa
90 kPa
50 kPa
50 kPa
26
ELECTROMAGNETIC COMPATIBILITY
WARNING: · Use of MY01 device adjacent to or stacked with other electrical
equipment should be
avoided as it could result in improper operation. If such use is necessary,
the MY01 device and other electrical equipment should be observed to verify
that they are operating normally. · 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 MY01 device,
including cables specified by the manufacturer. Otherwise, degradation of the
performance of this equipment could result. Note · MY01 has no cables or
physical accessories. Do not attempt to add any cables or accessories to the
device. · MY01 can communicate over a frequency band of 2.402GHz-2.4835GHz
with GFSK modulation and effective radiated power of 1mWatts.
27
Table 5: Electromagnetic Emissions Group and Classification
Attribute
Compliance/ Class Group
RF Emissions Group per CISPR 11
Group 1
RF Emissions Class per CISPR 11
Class B (although the device is not for residential environment use)
Table 6: Electromagnetic Immunity Levels
Attribute
Compliance/ Class Group
Electrostatic Discharge (ESD)
± 8 kV contact ± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV air Per IEC 61000-4-2 3 V/m
Radiated RF EM fields
80 MHz – 2.7 GHz 80 % AM at 1 kHz Per IEC 61000-4-3
Proximity fields from RF wireless communiAs indicated in IEC 60601-1-2
cations equipment
Immunity to Rated Power frequency mag- 30A/m at 60Hz, 50Hz
netic field
Per IEC/EN 61000-4-8
28
Electrical Safety Compliance Statement The MY01 compartmental pressure monitor
complies to IEC 60601-1 and IEC 606011-2 FCC Compliance Statement This device
complies with FCC Subpart 15C rules 15.247. 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. Changes or modifications to
this product not authorized by MY01 Inc. could void the electromagnetic
compatibility and negate your authority to operate the product.
Canadian Regulatory Statement / Déclaration réglementaire Canadienne This
device complies with Industry Canada licence-exempt RSS standard(s). 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.
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, et
(2) l’utilisateur de l’appareil doit accepter tout brouillage radioélectrique
subi, même si le brouillage est susceptible d’en compromettre le
fonctionnement.
29
Reorder information
REF MY01-0001
Product Description MY01 Continuous Compartmental Pressure Monitor
MY01-APP
MY01 Mobile Application & Cloud Database
30
Date of release : 23 Apr 2023 P/N : MYO-00119-M
MY01 Inc. 400 Boul de Maisonneuve Ouest, Suite 700, Montréal, QC, Canada H3A 1L4 +1 855-799-6901
CH REP MedEnvoy Switzerland Gotthardstrasse 28 6302 Zug Switzerland
31