Nellcor PediCap Manual page 2

ENGLISH
PediCap®
Pediatric End-Tidal CO Detector
2
Rx ONLY
Directions for Use
Description
The Pedi-Cap® detector, when connected between an endotracheal tube
and a breathing device, detects approximate ranges of end-tidal CO
color comparison in patients weighing 1–15 kg (2.2–33 lb). The detector
may be used during patient transport or in any location where intubations
are performed. It may be used for up to two hours.
Indications
Use to assist verification of tube placement during endotracheal or
nasotracheal intubation.
Use on intubated patients to detect approximate ranges of end-tidal CO
when clinically significant.
Contraindications
• Not to be used for detection of hypercarbia.
• Not to be used to detect main stem bronchial intubation.
• Not to be used during mouth-to-tube ventilation.
• Should not be used to detect oropharyngeal tube placement.
Standard clinical assessment must be used.
WARNING:
1. Before using the Pedi-Cap detector, read complete Directions for
Use.
2. Do not use this device on patients with body weight greater than
15 kg due to potential increased airway resistance.
3. The Pedi-Cap detector is not suitable for interpretation by
individuals with blue-yellow color blindness.
Instructions for Use
1. Match the initial color of the indicator to the purple color labeled
CHECK around the detector window as shown in
If the purple color of the indicator is not the same color or darker than
the area marked CHECK, DO NOT USE.
2. Insert the endotracheal tube. Inflate the cuff, if equipped.
3. Firmly attach the Pedi-Cap detector to the endotracheal tube; then
attach the breathing device, as shown in
4. When a Heat and Moisture Exchanger (HME) is used, note:
by
2
2
.
.
2
• Connect the HME to the endotracheal tube
• Connect the PediCap detector to the HME
• Connect the breathing device to the PediCap detector
5. Ventilate the patient with SIX BREATHS of moderate tidal volume
(may be done slowly or quickly). Compare the indicator color in the
window on full-end expiration to ranges printed on the detector cover.
Interpret results according to the decision tree that follows.
If Pedi-Cap detector results are not conclusive, the endotracheal tube
should be immediately reinserted unless correct anatomic location can
be confirmed with certainty by other means.
WARNING: INTERPRETING RESULTS BEFORE CONFIRMING SIX
BREATH CYCLES CAN YIELD FALSE RESULTS.
Gastric distention with air prior to attempted intubation may
introduce CO levels as high as 4.5% into the Pedi-Cap detector if the
2
endotracheal tube is misplaced in the esophagus. Initial Pedi-Cap
detector color (yellow) may be interpreted as a false positive if read
before delivery of six breaths.
WARNING: THE PEDICAP DETECTOR WILL RESPOND TO CO
THE PRESENCE OF A MAIN STEM BRONCHIAL INTUBATION.
STANDARD CLINICAL ASSESSMENT SHOULD BE USED TO
CONFIRM PROPER POSITION OF THE ENDOTRACHEAL TUBE
WITHIN THE TRACHEA.
CAUTION
STORE AT OR BELOW 24°C 75°F. STORAGE FOR EXTENDED
PERIODS AT TEMPERATURES ABOVE 24°C 75°F MAY REDUCE
SHELF LIFE.
CAUTIONS:
1. Inspect the Pedi-Cap detector before attaching it to the
endotracheal tube. Do not use if any physical damage is observed.
2. Large airway leaks may decrease tidal volume delivered to the
detector which can limit the accuracy of the Pedi-Cap detector.
3. Do not use device in the presence of trichlorethylene or
chloroform anesthetic; chemical interactions will affect device
accuracy.
A
IN
2
B
Pedi-Cap
detector
Connect
Connect to breathing
ET tube device
here
3