Introduction; Unpacking / Preliminary Checks; Safety; Warnings - Huntleigh FD1 Instrucciones De Uso

1.

Introduction

The FD1 & FD3 are battery powered, handheld Dopplers for obstetric use. They provide an audible fetal heart
sound and a numerical display of fetal heart rate. This equipment is for use only by suitably qualifi ed healthcare
practitioners and is not intended for use by the patient.
Before using this equipment, study this manual carefully and familiarise yourself with the controls, display
features and operation.
Experience with use of ultrasonic Dopplers is preferable, but for novice users training material is provided with
the online documents. Exposure to ultrasound should be kept As Low As Reasonably Achievable - (ALARA
guidelines).
Scan the QR code on the rear cover of this IFU with a smartphone, or visit the Huntleigh website for electronic
copies of user literature. All documents are available to download as PDF fi les. To read them, you must have a
PDF reader installed on your device. Alternatively paper copies are available upon request.
1.1

Unpacking / Preliminary Checks

On receipt of your Doppler, check that all items are present and undamaged. If items are missing or have been
damaged in transit, inform Huntleigh Healthcare immediately.
Handheld Doppler
Carry bag
2.

Safety

2.1

Warnings

• Dopplers are screening tools to aid the healthcare professional. If there is doubt as to fetal status, further
investigations should be undertaken immediately using alternative techniques.
• Always ensure that Maternal HR or any Artefacts are not misinterpreted as fetal heartrate. If in doubt, feel
the mother's pulse during the examination.
• Do not use in the presence of fl ammable gases.
• Do not use in a sterile fi eld unless additional barrier precautions are taken.
• Do not sterilise the product or its accessories. The product will be damaged.
• Do not expose to excessive heat, including prolonged exposure to sunlight.
• Do not dispose of batteries in fi re as this can cause them to explode.
• The Doppler unit is not waterproof and must not be immersed.
• This product contains sensitive electronics, which are susceptible to interference, this will be indicated by
unusual sounds.
• This equipment must not be modifi ed.
2.2

Patient Applied Parts

As defi ned in IEC 60601-1, the patient applied parts of the FD1 and FD3 Dopplers are the ultrasound probes.
2.3 Intended Use & Indications
The Dopplers are intended for use by qualifi ed healthcare practitioners in primary, acute and community
healthcare environments, for the assessment of fetal heart rate.
They are indicated for routine screening of pregnant women of all ages from early gestation through to full term,
and for low risk labour management.
2.4

Contraindications

• Do not use on broken or fragile skin.
• Do not use on the eye.
IFU (this document)
Ultrasound Gel
Battery
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