User & Patient Safety Precautions
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.
Do not ship, store or use the device outside the specified environmental conditions (See table 2).
Single-use device, do not reuse. Patient safety may be compromised.
Do not use the device past the expiration date.
Do not re-sterilize 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 judgement when performing measurements.
Do not dispose of dispenser packaging until all devices are used.
No known contraindications
Additional Warnings
Do not use trend arrows for diagnostic purposes. Always use pressure measurements and clinical judgment along with the current standard of care.
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.
Do not use the device if the integrity of the packaging is compromised.
Always turn ON the device BEFORE introducing into patient.
Do not use the device if pressure measurements are not within -2.5 to 2.5 mmHg prior to insertion.
Always keep the Pressure Vent on the bottom-right of the screen unobstructed at all times.
Do not use the device if the Sensor unhooks unexpectedly during the insertion. Never attempt to re-assemble the device.
Do not rotate the Introducer during insertion to prevent premature Sensor unhooking.
Do not perform more then 5 single-point pressure measurement.
Ensure there is no coagulated or dried blood on the Sensor between single-point measurements.
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 is not covered by the medical tape.
Sharps Biohazard - dispose as per facility guidelines and/or local regulations.
Do not leave the Sensor inside the patient for a period longer than 24 hours.
The device is for single patient-use only. Do not attempt to reassemble the device or replace the batteries after use.
Always remove the Pressure Monitor from the patient before preforming a corrective procedure (e.g. fasciotomy, amputation, debridement, skin graft).