COLOR CHANGE REFERENCE GUIDE

Adult and Pediatric Colorimetric CO2 Detector

Instructions for Use:

Description

The VisuBreath device is a sticker specifically designed to be used by healthcare providers to confirm spontaneous ventilation for non-intubated patients. The device provides for the semi-quantitative visualization of CO2 in a patient’s clear oxygen mask as it colorimetrically responds to the presence of carbon dioxide in the patient’s exhaled airstream. It is a disposable, continuous color changing sticker as shown in the figure below. The device is intended for use on spontaneously breathing, non-intubated, general care patients, including adult and pediatric. The device is an adjunct in patient assessment to be used in conjunction with other methods to determine clinical signs and symptoms.

Indications for Use

The VisuBreath is to provide a semi-quantitative visualization of the CO2 in the patient airway. It is an adjunct in patient assessment, to be used in conjunction with other methods to determine clinical signs and symptoms by or on the order of a physician. The VisuBreath has a visual indicator to visually detect the end of exhalation.

For use up to 24 hours.

For patients greater than 15kg (33 lbs).

Environment of use - hospital, sub-acute, pre-hospital, transport.

Contraindications

Do not use to detect hypercapnia/hypercarbia.

Do not use on mechanically ventilated patients.

Do not use on patients that are not spontaneously breathing.

Do not use as a stand-alone diagnostic monitor for end - tidal carbon dioxide (EtCO2). 

Do not place the VisuBreath detector directly onto the patient skin.

Contraindicated for infants and neonatal.

Warnings

1.      Before using the VisuBreath device, read the complete Instructions for Use.

2.      The VisuBreath device is not suitable for interpretation by individuals with blue-yellow color blindness.

3.      Do not use on patients with a body weight less than 15kg.

4.      Ensure that the device is securely adhered to the display surface, failure to do so could create an upper airway hazard. 

5.      Impaired or interrupted exhalation can lead to the appearance of normal breathing on the detector. If impaired or interrupted exhalation is suspected, a secondary method may be required to confirm breathing.

Precautions

1. The VisuBreath device is Single Use Only. Do not reapply the device once it is removed.

2. Do not use the VisuBreath device if the package has been opened, or appears used, damaged, or expired. 

3. Do not use the VisuBreath device if, when opening the package, the device indicates a yellow color.

4. Incorrect handling, excessive force, or dropping the VisuBreath device may cause a malfunction or permanent damage to the device. 

5. If the VisuBreath fails to operate, ensure correct placement of the device. 

6. Dispose of the Visubreath device per local laws, care facility laws or hospital laws for routine/non-hazardous waste.

Product Storage

1.      Storage temperature range: 5-25°C

2.      Storage relative humidity range: 10-95% RH

Not made with natural rubber latex.

Store temperature requirements.

Single use product. Do not reuse.

Consult instructions for use.

Do not use if packaging is damaged.

Non Sterile.

Symbols Glossary

VisuBreath Operating Instructions

VisuBreath OVERVIEW

Product Orientation

Note: Orientation of the Indicating Side and Blank Side are important when placing the device. 

See image below for a view of the VisuBreath device, showing the Indicating Side and the Blank Side. 

INDICATING SIDE

BLANK SIDE

Product Handling

Ensure hands are clean and dry before handling the VisuBreath device. Gloves are recommended when handling the device.

When handling the VisuBreath device minimize contact with the indicating side: do not touch the colored center of the indicator and reduce contact with the adhesive the surrounds it if possible. Contact with the center color indicator may deteriorate the indicator and affect the duration of use of the device. Contact with the adhesive prior to placement may deteriorate the adhesive and compromise its integrity. 

REDUCE CONTACT WITH ADHESIVE WHEN HANDLING

VISUBREATH INSTALLATION INSTRUCTIONS

Step 1: Display Surface Preparation. 

The primary suggested application site is located on the inside of a clear oxygen mask.

For good adhesion to the display surface, use an alcohol wipe to clean the surface of any oils and moisture. Allow the site to dry. The site should be clean and dry before applying the device to the display surface.

Step 2: Remove the VisuBreath from the pouch.

Peel open the pouch by separating the two sides at the chevron end and remove the VisuBreath device carefully. It is mounted on a clear square backing. Do not remove the detector from its backing until ready to install. 

SEALED POUCH

OPEN POUCH

DETECTOR STICKER ON BACKING

Step 3: Inspect the VisuBreath CO2 Detector Sticker.

The indicating side shall be color blue out of the packaging and remain blue while in the absence of CO2.

Step 4: Evaluate and Position VisuBreath near the nose and mouth.

It is important to place the device on the most visible surface. The primary placement surface is on a clear oxygen mask, above the nose (see image below). The blue indicator side will be placed to face the healthcare provider. Further, the device must be placed where the patient’s breath will flow over the device.

ASSESSING WHERE TO PLACE VISUBREATH

Step 5: Apply the VisuBreath to the display surface.

Remove the square shaped backing from the round device. Without touching the center colored indicator and with minimal adhesive contact, apply to the display surface. Colored side touching the mounting surface.

REMOVE BACKING

Press down around the edges of the back of the device (white side) to ensure it is well adhered to the surface.

ENSURE ADHESION TO SURFACE

Step 6: Confirm device is functioning properly.

Place the device near the patient’s nose or mouth.

Confirm that the device is placed correctly by observing the continuous color change of the device from blue to yellow as the patient inhales and exhales air. 

CONFIRM COLOR CHANGE

BLUE (INHALATION)

YELLOW (EXHALATION)

If the device is not changing and is in the correct placement, remove the VisuBreath and replace with a new one following the Display Surface Preparation steps described previously. 

VisuBreath Removal and Disposal

If the device is used with a single use display surface (i.e., clear oxygen mask), it can be disposed of with the display surface. 

Otherwise, carefully remove the device from the display surface and discard in non-hazardous waste.