OPERATIONAL INSTRUCTIONS 

Step 1: Peel the Tyvek lid where indicated. Lift the top cover and remove the device from the packaging. 

  • 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 and holding the Push-Button until the MY01 logo appears. The Display will subsequently show the MY01 logo and pressure value of 0.

  • 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: While holding the Introducer (see Figure 8), ensure that the information on the Display is visible. Remove Needle Cap. 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 at all times. 
  • 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 (see Figure 10), 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). 


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