Huntleigh SONICAID FREEDOM SF1-EUR User manual

SF1-EUR

Contents
1. Introduction........................................................................4
1.1 Indications of Use..................................................................................4
1.2 Contraindications ..................................................................................4
1.3 Unpacking / Preliminary Checks..........................................................5
2. Safety .................................................................................6
2.1 WARNINGS.............................................................................................7
3. Product Information ...........................................................9
3.1 System Overview...................................................................................9
3.2 The Receiver Unit...................................................................................10
3.2.1 Operation................................................................................................................10
3.2.2 Front Panel Indicators............................................................................................11
3.2.3 Rear Panel controls and Indicators........................................................................13
3.3 The Transducers....................................................................................14
3.4 Product Labelling...................................................................................16
4. Setup...................................................................................17
4.1 Receiver Connection.............................................................................17
4.2 Testing the Basic Functions.................................................................17
5. Operation ...........................................................................19
5.1 Getting Started.......................................................................................19
5.2 Application of the Transducers............................................................19
5.3 Ambulatory Monitoring .........................................................................21
5.4 Water Birth Monitoring..........................................................................21
5.5 Ending Monitoring / Switching Off.......................................................22
6. Care and Cleaning ..............................................................23
6.1 General Care...........................................................................................23
6.2 Cleaning and Disinfecting.....................................................................24
6.2.1 Transducers ...........................................................................................................24
6.2.2 Receiver Unit..........................................................................................................26
7. Maintenance.......................................................................27
7.1 Mechanical Inspection ..........................................................................27
7.2 Corrective Maintenance ........................................................................27
7.3 Charging Transducer Batteries............................................................27
7.4 Transducer Battery Replacement.........................................................27
7.5 Servicing.................................................................................................27

3
Table of Contents
8. Trouble Shooting ................................................................28
8.1 Manually Switching off the Transducers.............................................30
8.2 Re-enabling Transducers......................................................................31
8.3 Changing the RF-channel .....................................................................32
9. Specifications ....................................................................33
9.1 Equipment Classification .....................................................................33
9.2 Receiver Unit (SF1-EUR / SF1-SL)........................................................33
9.3 US-Transducer (SF1-US).......................................................................34
9.4 TOCO-Transducer (SF1-TOCO) ...........................................................34
9.5 Environmental........................................................................................34
9.6 Directives and Standards Compliance*...............................................35
9.7 Recommended Consumables & Accessories* ..................................35
10. Electromagnetic Compatibility ........................................36
11. Ultrasound Safety Considerations ...................................37
12. End of Life Disposal..........................................................41
13. Warranty & Service ..........................................................42

4
Introduction
1. Introduction
1.1 Indications of Use
The Sonicaid™ Freedom (‘Freedom’) is a wireless fetal monitoring system
for the monitoring of fetal heart movement and maternal contractions
during intrapartum and antepartum periods of pregnancy.
It is an optional accessory for use with Huntleigh Healthcare Limited’s
approved Fetal Monitors such as Sonicaid FM820, FM830 Encore Fetal
Monitors (‘FM800E Monitors’) and Team Monitors (Excluding TeamIP) as
an alternative to their wired transducers. When connected to a suitably
approved Monitor, the system monitors:
• Uterine activity by using an external, pressure-sensitive TOCO
transducer, and
• Fetal heart rate (FHR) by pulsed Doppler ultrasound using an external
Ultrasound transducer.
Freedom is suitable for use in clinical and hospital facilities for use on
pregnant woman. The transducers are water tight allowing pregnant
women to be monitored while they are mobile, stationary or in a bath or
shower environment.
This system should only be used by, or under the supervision of, a
licensed physician or other health practitioner who is trained in the use of
FHR monitors.
1.2 Contraindications
Sonicaid™ Freedom is not intended for use with patients fitted
with cardiac pacemakers, during defibrillation, while undergoing
surgery, or while MRI scanning is taking place.
Sonicaid™ Freedom must not be used in intensive care units or
operating rooms.

5
Introduction
1.3 Unpacking / Preliminary Checks
Contents (supplied with each system)
Item Item Item
1 x Sonicaid™ Freedom
Receiver Unit
(WMTS: SF1-SL or
ISM: SF1-EUR)
1 x Instructions for
Use CD 1 x Receiving Antenna (Gainflex - GF430TNC)
1 x Ultrasound Transducer
(SF1-US) 1 x Interface Cable 2 x Transducer Clips
1 x TOCO Transducer
(SF1-TOCO) 1 x Mains Lead 1 x FM800E to Sonicaid™ Freedom
Fixing Kit
Delivery Inspection
Huntleigh takes every precaution to ensure that goods reach you in perfect
condition. However, accidental damage can occur in transit and storage.
For this reason we recommend that a thorough visual inspection is made
immediately the unit is received. Should any damage be evident or any parts
missing, ensure that Huntleigh or your distributor is informed at once.
Storage
Should the unit not be required for immediate use, it should be re-sealed into
its original packing after carrying out the initial delivery inspection, and stored
under covered conditions at a temperature between -10°C to +50°C, and
relative humidity of 10% to 93% non-condensing.