Product Description
Deroyal 81-020409 - General Purpose Temperature Probe, 400 Series Regular, 9FR, 50/Cs
Deroyal 81-020409 General-Purpose Temperature Probe Features & Benefits
The General Purpose Temperature Probe consists of a temperature-sensing wire set that is enclosed within a smalldiameter plastic tube for ease of application. The probe is available in 9 and 12 French sizes and may be inserted into the nasopharyngeal, esophageal, and rectal cavities.
- For routine monitoring of patients core body temperature
- Versatile design allows for oral, nasal, or rectal introduction
- Low-friction surface for ease of insertion
- Positive-locking connector for secure cable connection
- Completely enclosed sensor wires for improved stability and hygiene
- Thin, flexible design ensures optimal patient safety
- Non-toxic, non-porous material for patient safety
- Fully compatible with most monitors
- Available in both regular and soft flexibility for enhanced patient comfort
- Not made with natural rubber latex
- DEHP free
- Sterile
Intended Use
The DeRoyal General Purpose Temperature Probe is to be used for routine monitoring of core body temperature.
Deroyal 81-020409 Directions for Use
- Remove the probe from its sterile package.
- Verify the compatibility of the probe, interface cable, and patient monitor
- Lubricate the probe tip with a suitable water soluble lubricant
- Insert the probe and guide it into either the rectum, esophagus, nostrils or nasopharynx cavity
- Connect the temperature probe to the appropriate reusable temperature cable from DeRoyal. Connect the cable to the patient monitor. Secure the cable using drape clip.
- Follow the directions for use of the patient temperature monitor instrument.
- If used in the esophagus, 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 on cable or wire.
- This probe is NOT reusable
- Dispose of probe according to facility protocol.
MR Compatibility
The DeRoyal General Purpose Temperature Probe has not been evaluated for safety and compatibility in the MR environment. It has not been tested for heating, migration, or image artifact in the MR environment. The safety of the GP Probe in the MR environment is unknown. Scanning a patient who has this medical device may result in patient injury.
Deroyal 81-020409 General-Purpose Temperature Probe 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 |
