FHR monitor, continuous, portable

GENERAL DESCRIPTION
Portable, handheld, foetal heart rate monitor

INTENDED USE
A portable, hand-held, battery-powered device assembly consisting of a measuring and display unit and an attached probe or interchangeable probes designed to noninvasively detect foetal heart beats using ultrasound/Doppler technology. The heart beats are typically conveyed audibly via the measuring/display unit and attached probe which is applied to the surface of the pregnant woman's abdomen. The device aids in determining foetal viability.

TECHNICAL SPECIFICATION
Device for non-invasive detection of foetal heart rates, either continuous or intermittent.
Portable, battery operated.
Suitable to be used for ambulatory patients.
Including ultrasound probe.
Designed with a wide detection area thus making positioning of the probe less critical and making the device less sensitive to movement of the mother.
Capable of detecting foetal heart rates between 50 - 210 bpm, with an accuracy of ± 5 bpm between 50 - 200 bpm.
Capable to measure maternal heart rates between 30 - 250 bpm, with an accuracy of ± 5 bpm between 50 - 150 bmp.
Contains a built-in speaker which can convey the foetal heart rate audible or be switched off.
Including display indicating the foetal and maternal heart rates.
Memory allowing for storage of 30 minutes foetal heart rate trend.
Rechargeable battery with a minimum capacity for 5 hours continuously monitoring.
Battery charger suitable for 100 - 240 volt / 50 - 60Hz.
Suitable for cleaning with hospital grade products

ALARM FUNCTIONALITIES
Alarms are visual and audible
Alarms can be silenced
Alarm when the foetal heart rate cannot be detected, indicate applicable ranges:
Alarms for low and high foetal heart rates, indicate applicable ranges
Alarm for low battery

SUPPLIED WITH
Instructions for assembly, use and maintenance in English, French and Spanish.
1 x Pouch or container to store the device and its components.
1 x Adjustable strap to position the probe around the belly of the mother
1 x Battery charger

REQUIRED BUT NOT INCLUDED
1 x S0845182, Gel, ultrasound, bottle, min. 250ml

ESTIMATED LIFE SPAN
The estimated life span is 3 – 5 years

WARRANTY
Warranty period is two (2) years including supplied accessories.

ENVIRONMENTAL CONDITIONS
Storage conditions: -30 - 70°C / 95% relative humidity.
Operating conditions: 0 - 40°C / 95% relative humidity.
Atmospheric pressure: 800hPa to 1060hPa (Storage: 550hPa to 1060hPa)
Ingress Protection rating: IP41

WEIGHT AND VOLUME (packaged)
Weight: 1.15 kg.
Volume: 4.33 dm³

ESTIMATED DELIVERY LEAD TIME
28 days.

INSTALLATION REQUIREMENTS
This product does not require installation or commissioning.

TRAINING REQUIREMENTS
Studying the user instructions prior to utilization will be sufficient.

MAINTENANCE/USER REQUIREMENTS
As per user and service manuals.

COMPONENT OF A KIT
No part of a kit.

QUALITY MANAGEMENT SYSTEM
- Supplier and Manufacturer is certified for ISO 13485 Medical devices - Quality management systems - Requirements for regulatory purposes.

CLASSIFICATION
Classified under EU MDD 93/42/ECC as Class IIa device.

SAFETY & PRODUCT STANDARDS
- IEC 60601-1: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
- IEC 60601-1-2: Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests.
- IEC 60601-1-6: Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability.
- IEC 60601-1-8: Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
- IEC 60601-2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment.

NOMENCLATURE
- GMDN code: Foetal Doppler system (34040).

LABELLING
- Products MDD - CE certified follow labelling requirements as stipulated in EU MDD 93/42/EEC, Annex I, point 13.3. Follow below hyperlink for details on this regulation.
https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:31993L004 2&qid=1638369660570&from=EN