Fetal Transducer User Manual
Intended Use & Indications for Use
These transducers are intended to be used as replacement accessories to fetal monitors to measure fetal heart rate and uterine contractions in the gravid patient.
- Make sure the compatibility of the transducer. See the attached the compatible label to ensure the device used
with is compatible with the transducer.
- Make sure the transducer plug matches the connector on the device. Then fully plug the probe into the device.
- At the bedside monitor , ensure that the tracing is recording FHR, not MHR.
- After monitoring in a watery environment , transducers and cables should be thoroughly dried.
USE IN SHOWER OR TUB:
Note: When using watertight transducers for monitoring in a watery environment, it is recommended that the
buttontop transducer and reusable buttonhole belts be used for the best results.
- USE TRANSDUCERS IN A WATERY ENVIRONMENT ONLY WHEN CONNECTED TO A TELEMETRY SYSTEM. DO NOT ALLOW THE TELEMETRY SYSTEM TO GET WET.
- DO NOT USE THE TRANSDUCER IN A WATERY ENVIRONMENT WHEN CONNECTED DIRECTLY TO A FETAL OR MATERNAL/FETAL MONITOR THAT IS DIRECTLY CONNECTED TO AC LINE POWER.
The Ultrasound and Toco Transducers with its compatible ultrasonic Doppler fetal monitor has been validated and tested for compliance with IEC 60601-2-37.
Comparative value measurement in % saturation:Ultrasound FHR Range (65-200 circle) ------ Accuracy ±2 circle/min
Uterine Activity Range (0-100unit) ----------- Linear error ±10%
Cleaning & Disinfecting
- When cleaning or disinfecting, please disconnect the transducer with the monitor;
- Clean or saturate the transducer before applying to a new patient.
- The transducer may be surface-cleaned by wiping it with a solution such as 70% isopropyl alcohol. If low-level disinfection is required ,use a 1:10 bleaching solution. Do not use not use undiluted bleach(5% ~ 5.25% sodium hypochlorite) or any cleaning solution other than those recommended here because permanent damage to the sensor may occur.
- Saturate a clean, dry gauze pad with the cleaning solution. Wipe all surfaces of the transducer with this gauze pad; Saturate another clean, dry gauze pad with sterile or distilled water. Wipe all surfaces of the sensor and cable with this gauze pad; Dry the transcucer by wiping all surfaces with a clean, dry gauze pad.
- Attention: do not expose the connector pins to the cleaning solutions as this may cause permanent damage to both the sensor and the monitor.
Storage and Handling:
When not in use, transducers should be loosely coiled and stored in room temperature. Don’t wrap transducers around equipment cases to avoid damaging internal wires.
Environment Operating Range:
The manufacturer offers 12 months warranty against defects in material or workmanship from the date of purchase. But does not cover the damage or breakage due to the abusive use or negligent care of the cable. We guarantee that the equipment conforms to the specifications of the safety and performance standards currently in force and applicable to it.
- Transducers are designed for use with specific monitors.
- The operator is responsible for checking the compatibility of the monitor,transducer and cable before use.
- Incompatible components can result in degraded accuracy and performance.
- Consult the operation instructions for the equipment concerned and the related accessories before operating equipment to ensure their compatibility.
- Portable and mobile RF communications equipment can be affect equipment.
- Disposal of the transducers shall comply with local regulation.
- Do not use the sensor during MRI scanning. Conducted current may cause burns. Also, the sensor may affect the MRI image, and the MRI unit may affect the accuracy of measurements.
- Do not immerse transducer or transducer connector ends in cleaning solution(s).
U.S. federal law restricts this device to sale by or on the order of a physician.
According to local laws and regulations to deal with waste fetal transducer.
|Date of manufacture|
|Crossed out wheelie bin indicates separate treatment from general waste at end of life.
Waste of Electrical and Electronic Equipment Directive (WEEE)
|Protection against moisture|
|U.S. federal law restricts this device to sale by or on the order of a physician.|
|European Authorized Representative|