Huntleigh SONICAID FREEDOM SF1-EUR Скачать руководство пользователя страница 35 | Manualshive

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9.6 Directives and Standards Compliance*

European Directives:

The Sonicaid™ Freedom complies with the essential requirements of the
Medical Devices Directive (93/42/EEC) with amendments by 2007/42/EC and
the Radio and Telecommunications Terminal Equipment Directive (1999/5EU).

Standards:

Safety

IEC/UL/CSA/EN 60601-1 (Second Edition)
IEC/ANSI/AAMI/CSA/EN 60601-1 (Third Edition)
EN60601-1-6:2010, IEC 60601-2-37:2007

Electromagnetic
Compatibility

EN60601-1-2:2007
FCC 47 Part 15 Subpart B

Radio

ETSI EN 300 220-2: V2.3.1 (2009-12)
ETSI EN 301 489-1 V1.9.2 (2011-09)
ETSI EN 301 489-3 V1.6.1 (2013-06)
FCC 47 CFR Part 15 Subpart C and Part 95; Subpart H
(WMTS), RSS-210

Labelling

BS EN15223-1:2012

9.7 Recommended Consumables & Accessories*

WARNING: Use only recommended accessories/consumables
listed in this manual.

Item

PN

Aquasonic Gel 5ltr container (each)

ACC-1300-0154

Aquasonic Gel (box of 12 x 250ml)

ACC3

Ultrasonic Gel (box 12 x 60ml tubes)

ACC24

Latex free Reusable transducer belts (pair)

ACC-MI1136

Transducer Clips

ACC-OBS-051

Ultrasound Transducer (SF1-US)

ACC-OBS-055

TOCO Transducer (SF1-TOCO)

ACC- OBS-053

Transducer Bumper

ACC-OBS-054

Mounting Bracket (To mount the Receiver to an
FM800E Monitor)

ACC-OBS-050

Service Manual

778345

*This list is not fully comprehensive

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Содержание SONICAID FREEDOM SF1-EUR

Страница 1: ...SF1 EUR...

Страница 2: ...ling 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 Birt...

Страница 3: ...s 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...

Страница 4: ...nal 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...

Страница 5: ...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 i...

Страница 6: ...s Low As Reasonably Achievable General Warning Residual risks are those risks that require a warning or caution to be entered into this manual They are identified by the proximity of this symbol This...

Страница 7: ...o Huntleigh Healthcare qualified service personnel for repair The transducers are protected from damage if dropped Never use the transducer without its protective bumper It can be removed for cleaning...

Страница 8: ...out 5 seconds To disconnect from the mains the plug must be removed Always ensure that the plug is easily accessible The receiver unit should be plugged into the same mains supply circuit as other equ...

Страница 9: ...reless transmission is safe for use in water No cables gives the patient greater freedom of movement in out of bed The system is easy for the users to operate The transducers are powered by rechargeab...

Страница 10: ...ransducer transmits its signal to the US transducer The US transducer transmits both the US and TOCO signals to the receiver 3 2 The Receiver Unit 3 2 1 Operation The receiver does not have a mains sw...

Страница 11: ...docked the battery is charged automatically provided the receiver is connected to the mains supply Once a transducer has been positioned correctly for charging a Green LED in the corresponding holder...

Страница 12: ...ay clear the problem A flashing LED may also occur if the docking contacts or the contact rings on the transducer are contaminated with fluids gel etc Refer to the cleaning instructions for cleaning t...

Страница 13: ...r TOCO Transducer out of range LED green Transducer in range and good signal quality LED flickering green amber Transducer near range limit or disturbance by another RF transmitter If known to be in r...

Страница 14: ...Note that unpaired transducers will switch off when undocked If the LED on a paired transducer stays off refer to the troubleshooting guide section 8 Connections Contacting Plate On the top surface o...

Страница 15: ...r operate the transducer without this protective bumper It can be removed for cleaning if required Refer to Section 6 2 for instructions Transducer Application The transducers are applied using the be...

Страница 16: ...tial requirements of the Medical Devices Directive 93 42 EEC as amended by 2007 47 EC General Warning or Caution This product including its accessories and consumables is subject to the WEEE Waste Ele...

Страница 17: ...f the receiver unit to the interface input of the fetal monitor Connect the receiving antenna and select RF channel See Section 8 3 Dock the transducers with the receiver powered off Connect the mains...

Страница 18: ...active TOCO is indicated on fetal monitor Note The TOCO transducer must be in operating range of the US transducer Maximum range 30cm 6 Press gently on the sensor area of the transducer fetal monitor...

Страница 19: ...ransducer Fix the transducer to the belt clip Apply ultrasound gel to the surface of the transducer Note Use recommended gel only Do not use oil based gels Use the minimum amount of gel required to pr...

Страница 20: ...und the heart rate may be falsely reported This can be caused by a number of effects including double rating or half rating and is characteristic of ultrasound fetal monitoring Another cause may be de...

Страница 21: ...If the patient moves outside the wireless range the signal will be lost This is indicated by the transmission indicators on the receiver flickering or turning amber Note also that within the wireless...

Страница 22: ...the transducers on the receiver so they are easily located when you want to use the system again and so the transducer batteries can be charged For charging the transducer batteries the system must be...

Страница 23: ...facility s local infection control policy and medical equipment cleaning procedures Observe warnings and guidance on cleaning fluid labelling regarding use and personal protective equipment PPE Do no...

Страница 24: ...o known infection and the transducers have not been contaminated with blood Medium Risk The patient has a known infection skin is not intact the transducer is heavily soiled or the patient has given b...

Страница 25: ...Risk definition Unnecessary use of this concentrated solution for Low and Medium risk situations may result in damage to the transducer over time Remove the bumpers before cleaning 1 Remove soiling a...

Страница 26: ...lean and disinfect the receiver s exterior surface as described below 1 Wipe any fluids from the surface of the unit using a clean dry cloth 2 Wipe the receiver with a cloth dampened in 70 Isopropyl A...

Страница 27: ...All corrective maintenance must be performed by qualified engineers approved by Huntleigh The Sonicaid Freedom Service manual PN 778345 is designed as an aid to engineers in maintenance and service of...

Страница 28: ...patient is walking POSSIBLE CAUSE SOLUTION Patient out of range Ensure the patient understands the range limits and any local dead spots to avoid No signal on Fetal Monitor even though the indicators...

Страница 29: ...was wet or contaminated with gel when docked on the receiver Always clean and dry the transducer before docking and charging If necessary have the contact panel replaced Receiver or Transducer does n...

Страница 30: ...mally Refer to Section 3 2 8 1 Manually Switching off the Transducers If the green LED of the ultrasound or Toco transducer remain illuminated or the transducers lock up the following procedure must b...

Страница 31: ...ing the transducers along the right hand side of the receiver wall the transducers will switch off and reset accordingly The process will take approximately 2 3 seconds 8 2 Re enabling Transducers Aft...

Страница 32: ...el number ISM 00 25 26 channels channels 26 99 are same as channel 99 WMTS USA 01 99 100 channels channel 00 is same as channel 01 3 Re connect the receiver unit to mains and wait until the LED test i...

Страница 33: ...tion in the presence of a flammable anaesthetic Equipment not suitable for use in the presence of a FLAMMABLE ANAESTHETIC MIXTURE WITH AIR OXYGEN OR NITROUS OXIDE 9 2 Receiver Unit SF1 EUR SF1 SL RF R...

Страница 34: ...mer Battery Operating time Approximately 16 hours with fully charged battery Size 75x20mm Weight 105g 9 4 TOCO Transducer SF1 TOCO Measurement External pressure measurement of uterine activity Transmi...

Страница 35: ...12 ETSI EN 301 489 1 V1 9 2 2011 09 ETSI EN 301 489 3 V1 6 1 2013 06 FCC 47 CFR Part 15 Subpart C and Part 95 Subpart H WMTS RSS 210 Labelling BS EN15223 1 2012 9 7 Recommended Consumables Accessories...

Страница 36: ...ies with EN60601 1 2 the standard intended to provide reasonable protection against such interference Whether the equipment causes interference may be determined by turning the equipment off and on If...

Страница 37: ...rmed in accordance with the ALARA principle which states that the energy delivered to the patient should always be kept As Low As Reasonably Achievable The transmitted acoustic power of the Sonicaid F...

Страница 38: ...alue ISATA Transducer Face Note 1 3 92 mW cm2 ISATA Transducer Face DF Note 1 14 8 mW cm2 Area of Entrance Beam Dimensions AEBD Note 2 7 02 cm2 Note1 The values ISATA are statistical maxima calculated...

Страница 39: ...sis performed on the acoustic output data to examine the upper output limit based on a one sided tolerance limit approach The mean and standard deviation of the Spatial Peak Time Average Intensity and...

Страница 40: ...s Measurement Uncertainty Table 4 contains the measurement uncertainty of the acoustic output parameters stated in tables 1 2 and 3 above Table 4 Measurement Uncertainty of Acoustic Output Parameters...

Страница 41: ...isposal This symbol signifies that this product including its accessories and consumables is subject to the WEEE Waste Electrical and Electronic Equipment regulations and should be disposed of respons...

Страница 42: ...a decontamination certificate or other statement declaring that the product has been cleaned to the outside of the package Mark the package Service Department For further details refer to NHS document...

Страница 43: ...ect to the conformity assurance procedures laid down by the Council Directive Manufactured in the UK by Huntleigh Healthcare Ltd As part of the ongoing development programme the company reserves the r...

Страница 44: ...m Registered No 942245 England Wales Registered Office ArjoHuntleigh House Houghton Hall Business Park Houghton Regis Bedfordshire LU5 5XF Huntleigh Healthcare Limited 2013 with people in mind AN COMP...

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