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Deroyal 81-050418 - Esophageal Stethoscope, 400 Series - Soft Tube W/Temp. Sensor, 18FR, 50/Cs
Deroyal 81-050418 Esophageal Stethoscope, 400 Series - Soft Tube W/Temp. Sensor, Features and Benefits
The stethoscope portion of the device consists of a small diameter plastic tube upon which a flexible blue cuff is placed. When the device is inserted into the esophagus, the cuff facilitates transmission of sound to a male luer fitting at the proximal end of the tubing to which standard stethoscopes may be attached. The stethoscope is available in 9, 12, 18, and 24 French sizes
Secured within the lumen of the tubing is a temperature monitoring sensor. The connector at the proximal end interfaces with DeRoyal-branded cables for connection to a monitoring unit to display temperature. The temperature monitoring sensor is available in 400 or 700 series configurations for connection to a compatible monitoring unit. Consult the user manual for the patient monitor to ensure compatibility.
- Designed for use in surgical setting to monitor heart and respiratory sounds and to measure core body temperature in anesthetized patients
- Provides superior heart and respiratory sound transmission
- Available with or without temperature monitoring capability
- Complete line includes all popular French sizes
- Fully compatible with most monitors
- Available in extra-long lengths
- Available in both regular and soft flexibility for enhanced patient comfort
- Atraumatic, low-friction surface for ease of insertion
- Thin distal cuff allows optimal sound transmission and fidelity
- Positive locking connector for secure cable connection
- Not made with natural rubber latex
- DEHP free
- Sterile
Intended Use
The DeRoyal Esophageal Stethoscope with Temperature Sensor is to be used for routine monitoring of core body temperature, as well as to monitor heart and respiratory sounds in an anesthetized patient by inserting the stethoscope tube into the esophagus.
Contraindications
The use of an esophageal stethoscope may be contraindicated in patients with esophageal diverticulum or stenosis, in neonates or small infants undergoing neck surgery, in patients undergoing a tracheostomy or insertion of an internal jugular catheter, and in patients with conditions deemed unsafe for insertion of the stethoscope into the esophagus.
Deroyal 81-050418 Directions for Use
- Remove the Esophageal Stethoscope with Temperature Sensor from its sterile package.
- Verify the compatibility of the probe, interface cable, and patient monitor before use.
- Lubricate the cuff with suitable water soluble lubricant.
- Insert the stethoscope and guide it into the esophagus.
- Listen for airway leaks when inserting. Invasion of the trachea may permit air to escape around the tracheal tube cuff. Do not seal the leak. Remove the esophageal stethoscope and reinsert. To verify proper placement, use a laryngoscope.
- Adjust the stethoscopes depth in the esophagus to maximize the heart and respiratory sounds.
- Connect the temperature probe to the appropriate reusable temperature cable from DeRoyal. Connect the cable to the patient monitor. Secure the cable using the drape clip.
- Follow the directions for use of the patient temperature monitor instrument.
- Remove the probe prior to extubation of the tracheal tube following accepted medical technique.
- Disconnect the probe (at the connector) and discard the probe. To disconnect, grasp both connectors firmly and pull. DO NOT pull cable or wire.
- Dispose of probe according to facility protocol.
Safety in MRI Not Evaluated
The Esophageal Stethoscope with Temperature Sensors safety in MRI has not been evaluated, hence, the probe is considered MR Unsafe.
Deroyal 81-050418 Esophageal Stethoscope Device Characteristics
What MRI safety information does the labeling contain? | Labeling does not contain MRI Safety Information |
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437) | No |
Device labeled as "Not made with natural rubber latex" | Yes |
For Single-Use | Yes |
Prescription Use (Rx) | No |
Over the Counter (OTC) | No |
Kit | No |
Combination Product | No |
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P) | No |