Manometer With Manometer Adaptor; Warnings And Precautions - inhealth Blom-Singer Bedienungsanleitung

BLOM-SINGER

MANOMETER WITH MANOMETER ADAPTOR

®
PRODUCT DESCRIPTION
The manometer (with manometer adaptor) is supplied nonsterile in a kit containing one
manometer, one manometer adapter and one Blom-Singer Adhesive Housing. Replacement
manometer adaptors and housings are available separately. The manometer is reusable between
patients. The manometer adaptor and housing are disposable and intended for single use only.
Manometer with Adaptor
Manometer Kit
Replacement Manometer Adaptor Pack
INDICATIONS (Reasons to prescribe the device or procedure)
The manometer (diagram 1A) (with manometer adaptor) is for use by qualified, trained clinicians
as an aid to teach laryngectomized patients how to self-regulate intratracheal pressure during
tracheoesophageal speech.
CONTRAINDICATIONS (Reasons that make it inadvisable to prescribe the device or procedure)
The manometer (with manometer adaptor) is only indicated for laryngectomized patients who
speak using a tracheoesophageal voice prosthesis.

WARNINGS AND PRECAUTIONS

If there are tears, cracks, or structural damage, do not continue to use the product. The manometer
adaptor and housing are disposable and intended for single use only; reuse may result in cross
contamination. The manometer is pre-calibrated at the manufacturing facility. Tampering with the
instrument (e.g., unscrewing the device) may result in malfunction, inaccurate pressure readings,
and/or leaks of the gauge. Tampering with the connection fittings on the manometer adaptor may
result in inaccurate pressure readings.
INSTRUCTIONS FOR USE
Please refer to the diagrams located at the front of this instruction manual.
The clinician's hands should be clean and dry to help avoid introducing contaminants resulting
in patient infection. The included Blom-Singer adhesive housing must first be attached to the
skin surrounding the patient's tracheostoma. Follow the supplied Instructions for Use manual for
instructions on application of adhesive housing. The manometer adaptor (diagram 1B) should
be connected to the manometer before attaching the manometer adaptor to the tracheostoma
adhesive housing.
Manometer Adaptor Attachment
1. Attach the manometer adaptor to the manometer by inserting its female luer lock connection
(diagram 1C) into the male luer lock connection (diagram 1D) of the manometer. Twist the two
components together until securely connected.
2. Attach the manometer adaptor to the patient by inserting the tracheostoma connector end to
the tracheostoma adhesive housing (diagram 2).
Manometer with Manometer Adaptor Instructions for Use
Blom-Singer
®
ENGLISH
Manometer Adaptor
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AccuFit Housing
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37469-01H I 5