Table of Contents
Introduction
Warnings and Notes
Please read this manual and follow its instructions. The words WARNING and NOTE carry special meanings and should be reviewed carefully.
WARNING: The personal safety of the patient may be involved. Disregarding this information could result in injury to the patient.
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.
Components
Figure 1 : MY01 Device Dispenser
Figure 2 : Packaged MY01 Device
The MY01 Continuous Compartmental Pressure Monitor comprises the following 2 major components: the Introducer and the Pressure Monitor.
Figure 3 : Introducer
Figure 4 : Pressure Monitor (Applied Part)
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
Device Interface
Figure 5 : Device Controls and Display Icons
Significance of Trend Arrows
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 6 : Rotating Display Orientation
WIRELESS CONNECTION
BLUETOOTH SPECIFICATIONS
The MY01 device transmits identical pressure readings collected over time to the MY01 MobileApplication 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 | Gaussian Frequency Shift Keying (GFSK) |
Bluetooth Interface Security | 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.
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 10). The full pressure log can also be seen as a graph (Figure 11). Pressure data points are forwarded via an encrypted network link to a Cloud-based service (MY01 Application Server) for archival purposes. The data stored by the MY01 Mobile Application can be later retrieved.
Figure 7: Device Interface
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.
Figure 8: Refreshing the Device List
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 9: 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.
Figure 10: Device Connected
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 11: Data Display
DISCONNECTING FROM THE MY01 DEVICE
To disconnect from a MY01 device, slide the Device entry to the left and click on the “Disconnect” button.
Figure 12: Disconnecting
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, 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 package. Never attempt to re-assemble the device.
WARNING: Do not use the device if the integrity of the packaging is compromised.
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.
Note: Make sure to not touch the sensor tip while turning on the device
WARNING: Always turn ON the device BEFORE introducing into the patient.
WARNING: Do not use the device if pressure measurements are not within -2.5 to 2.5 mmHg prior to insertion.
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:
The Display can be rotated to the desired orientation to ensure visibility during the insertion.
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.
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.
WARNING: 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-points insertions). Never attempt to re-assemble the device.
WARNING: Do not rotate the Introducer during the 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.
Step 5: While holding the Introducer in one hand, use the other hand to adhere to 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.
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 that 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, 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.
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 of as per facility guidelines and/or local regulations.
Step 7: Monitor pressure readings up 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 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.
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 of 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.
WARNING: Always remove the Pressure Monitor from the patient before performing a corrective procedure ( e.g. fasciotomy, amputation, debridement, skin graft).
Troubleshooting
Figure 13 : Error Code Display
INSTRUMENT DEFECTS OR PRODUCT DEFICIENCIES
• For defective device concerns, or any related quality issues, please contact help@MY01.io 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 help@MY01.io or call +1 (855) 799-6901.
Specifications
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.
Electrical Safety Compliance Statement
The MY01 compartmental pressure monitor complies to IEC 60601-1 and IEC 60601-1-2
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 license-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.
Reorder Information
