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The Dopplex doppler is in conformity with the Medical Devices Directive

93/42/EEC as amended by 2007/47/EC and has been subject 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 right

to modify specifi cations and materials without notice.

Dopplex, and Huntleigh are registered trademarks of Huntleigh Technology Ltd.

2004.

© Huntleigh Healthcare Ltd. 2004-2014

Содержание D900

Страница 1: ...HIGH SENSITIVITY POCKET DOPPLERS D900 ...

Страница 2: ...ntrols 7 2 4 Product Labelling 8 3 Operation 9 3 1 Vascular Mode 9 3 2 After Use 10 4 Care and Cleaning 11 4 1 General Care 11 4 2 General Cleaning and Disinfecting 12 4 3 Cleaning and Disinfecting Patient Applied Parts 12 4 4 Maintenance and Repair 13 5 Specifications 14 5 1 Equipment Classification 14 5 2 Standards Compliance 14 5 3 General 15 5 4 Environmental 15 5 5 Accessories 15 6 Electromag...

Страница 3: ...VP10XS EZ8XS 7 Posterior Tibial Artery VP8XS EZ8XS 8 Vertebral Artery VP4XS VP5XS 9 Carotid Artery VP5XS VP8XS EZ8XS 10 Subclavian Artery VP4XS VP5XS 11 Brachial Artery VP8XS EZ8XS 12 Ulnar Artery VP8XS EZ8XS 13 Radial Artery VP8XS EZ8XS 14 Femoral Artery VP4XS VP5XS 15 Digital Artery VP8XS VP10XS EZ8XS 16 Penis VP10XS EZ8XS 17 Popliteal Artery VP5XS 18 Metatarsal Artery VP8XS VP10XS EZ8XS 19 Dors...

Страница 4: ...ay be used in the home healthcare environment by a qualified healthcare practitioner only and is for indoor use only Experience with use of ultrasonic Dopplers is preferable but for novice users training material is provided with the accompanying documents CD This product is not intended for use by the patient Please keep these Instructions for Use to hand for future reference General warning Atte...

Страница 5: ...IEC60601 1 2005 Connect headphones only to the headphone socket Dopplex Dopplers are screening tools to aid the healthcare professional and should not be used in place of normal vascular monitoring If there is doubt as to vascularity after using the unit further investigations should be undertaken immediately using alternative techniques This equipment must not be modified 1 2 Patient Applied Part...

Страница 6: ...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 as specified in Section 5 4 2 2 Battery Insertion...

Страница 7: ...uction 2 3 Product Controls 1 2 3 4 5 6 1 Headphone Socket 2 Waveform Socket 3 LED Panel 4 Loud speaker 5 On Off Button 6 Probe Holder 7 Volume Control 8 Cal Button 9 Battery Compartment 10 Pocket Clip 8 9 10 7 ...

Страница 8: ...al requirements of the Medical Devices Directive 93 42 EEC as amended by 2007 47 EC Rx Only Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner IP20 Protected against ingress of solid foreign objects 12 5mm diameter Not protected against ingress of water Power On Off Battery Alignment mark DI Device Identifier Volume Headphone Socket 40 C 10 C Tempera...

Страница 9: ... improve sound quality LED Indicators Green LED indicates power ON Yellow LED flashes when battery is low Coupling Gel Use water based ultrasound gel ONLY 3 1 Vascular Mode The D900 will select vascular mode when a vascular probe is connected to the control unit Vascular Probes Five probes are available for vascular examinations VP4XS 4MHz 1 for deep lying vessels VP5XS 5MHz 1 for deep lying vesse...

Страница 10: ...order refer to the manufacturer s handbook Cal Function The baseline and sensitivity of the chart recorder can be set up using the Cal function This generates a zero velocity baseline and a sequence of pulses as shown below Cal Pulse Two levels of calibration pulses are provided While Cal is active calibration tones synchronised to the calibration pulses are superimposed on the audio signal If the...

Страница 11: ...ck with your 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 not use abrasive cloths or cleaners Do not use automatic washers or autoclaves Phenolic detergent based disinfectants solutions containing cationic surfactants ammonia based compounds or per...

Страница 12: ...Definitions Procedure Low Normal use or low risk situations include patients having intact skin and no known infection and the probes have not been contaminated with blood 1 Remove soiling wipe with a mild neutral detergent and then wipe with a cloth dampened in water 2 Completely dry with a clean lint free cloth Medium The patient has a known infection skin is not intact the part is heavily soile...

Страница 13: ...r for their efficacy and compatibility with the device 4 4 Maintenance and Repair Inspection is recommended each time the product is used paying particular attention to the tip of the probes checking for cracks etc and to the cable and connector Any crackling or intermittent behaviour should be investigated This product does not require periodic maintenance Suitable test equipment and a full range...

Страница 14: ...ter Hand Unit IP20 All other probes IPX1 Degree of safety of application 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 5 2 Standards Compliance IEC60601 1 2005 C1 C2 IEC60601 1 11 2015 IEC60601 2 37 2007 IEC60601 1 2 2014 EN 60601 2 37 Thermal Indices TI and Mechanical Index MI are below...

Страница 15: ...ht 140mm Depth 27mm Width 74mm Weight 295g Service Life 7 years 5 4 Environmental WARNING The main unit enclosure does not provide protection from water ingress For homecare use we recommend the use of a protective pouch ACC OBS 080 However this will not protect the unit from immersion in liquids Operating Temperature range 5 C to 40 C Relative Humidity 15 to 93 non condensing Pressure 700hPa to 1...

Страница 16: ...d emissions or decreased immunity of the Doppler WARNING The Doppler should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary the Doppler should be observed to verify normal operation in the configuration in which it will be used WARNING Portable RF communications equipment including peripherals such as antenna cables and external antennas sho...

Страница 17: ...ld be at least 30 otherwise permanent damage could be caused to the Doppler Electrical fast transient burst IEC 61000 4 4 2kV for power supply lines 1kV for input output lines N A N A Surge IEC 61000 4 5 1kV line s to line s 2kV line s to earth N A N A Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 5 UT 95 dip in UT for 0 5 cycle 40 UT 60 dip in ...

Страница 18: ...ge applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a The ISM industrial scientific and medical bands between 150 kHz and 80 MHz are 6 765 MHz to 6 795 MHz 13 553 MHz to 13 567 MHz 26 957 MHz to 27 283 MHz and 40 66 MHz to 40 70 MHz b The compliance levels in the ISM frequency ban...

Страница 19: ...tter W Separation distance according to frequency of transmitter m 150kHz to 80MHz d 1 2 P 80MHz to 800MHz d 1 2 P 800MHz to 2 5GHz d 2 3 P 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres m can be estimated using the equation applicable to the frequency...

Страница 20: ...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 responsibly in accordance with local procedures ...

Страница 21: ...ng that the product has been cleaned to the outside of the package Mark the package Service Department D900 For further details refer to NHS document HSG 93 26 UK only Huntleigh Healthcare Ltd reserve the right to return product that does not contain a decontamination certificate For service maintenance and any questions regarding this or any other Huntleigh Healthcare Dopplex product please conta...

Страница 22: ...ct 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 right to modify specifications and materials without notice Dopplex and Huntleigh are registered trademarks of Huntleigh Technology Ltd 2004 Huntleigh Healthcare Ltd 2004 2014 ...

Страница 23: ...family we have been committed to supporting healthcare professionals in improving outcomes and enhancing patient wellbeing since 1979 We do this through our proven solutions for Vascular Assessment Treatment and Fetal Patient Monitoring With innovation and customer satisfaction as our guiding principles we strive for clinical excellence and improved performance for life A Member of the Arjo Family...

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