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Summary of Contents for Huntleigh D920
- Page 1 /D920/D930 HIGH SENSITIVITY POCKET DOPPLERS...
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Page 2: Table Of Contents
Table of Contents 1. Safety ................3 Warnings .................... 3 Patient Applied Parts ................ 4 Indications for Use ................4 Positioning ..................4 2. Introduction ..............5 Unpacking / Preliminary Checks ............. 5 Battery Insertion / Relacement ............5 Product Controls ................6 Product Labelling ................ -
Page 3: Safety
Do not use in the presence of fl ammable gases or oxygen rich environments. Do not use in the sterile fi eld unless additional barrier precautions are taken. Do Not : • immerse in any liquid, (except D920/D930 probe) • use solvent cleaner, • use high temperature sterilising processes (such as autoclaving), •... -
Page 4: Patient Applied Parts
As defi ned in IEC60601-1:2005, the patient applied parts of the Sonicaid Dopplers are the ultrasound probes. Indications for Use The D920 and D930 ultrasonic Dopplers are indicated for use by qualifi ed healthcare practitioners in primary, acute and community healthcare, for the detection of the fetal heart, to assist diagnosis. -
Page 5: Introduction
Unpacking / Preliminary Checks Contents 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. -
Page 6: Product Controls
Product Controls Headphone Socket LED Panel Loud-speaker On/Off Button Probe Holder Volume Control Battery Compartment Pocket Clip... -
Page 7: Product Labelling
Product Labelling Applied parts (ultrasound probes) are type BF according to the defi nitions in IEC60601-1:2005 This symbol signifi es 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. -
Page 8: Operation
Audio / Flexi Dopplex (D920/D930) Both the Audio Dopplex and the Flexi Dopplex have fi xed waterproof probes (IPX7) for underwater use. The D920/D930 main unit is not waterproof and must not be immersed. Clinical Use Apply a liberal amount of gel to the abdomen*. Place the faceplate of the probe fl... -
Page 9: After Use
Note that early detection (9-12 weeks) is highly depedent on operator skill and other factors and may not always be possible. *Note: For D920/D930 : Gel is not required when probe is used underwater. After Use Press and release the On/Off button. If you forget to switch the unit off, it will automatically shut-off after 5 minutes. -
Page 10: Care And Cleaning
Periodically, and whenever the integrity of the system is in doubt, carry out a check of all functions as described in the relevant section of the IFU. If there are any defects to the housing contact Huntleigh or your distributor for repair or to order a replacement. -
Page 11: General Cleaning And Disinfecting
General Cleaning and Disinfecting Always keep the external surfaces clean and free of dirt and fl uids using a clean dry cloth. Wipe any fl uids from the surface of the product using a clean dry cloth. Wipe with a cloth dampened in 70% Isopropyl Alcohol. Completely dry with a clean, dry lint free cloth. -
Page 12: Maintenance And Repair
Warning: Sodium Hypochlorite @ 10,000 ppm for disinfecting should only be used in situations described in the High Risk defi nition. Unnecessary use of this concentrated solution for Low and Medium risk situations may result in damage to the product. Do not allow Sodium Hypochlorite solutions to come into contact with metal parts. -
Page 13: Specifi Cations
Type BF - equipment with an applied part. Continuous Mode of operation. Hand Unit: IP20 * Degree of protection D920/D930 probes : IPX7 against harmful ingress of particles and/or water. Equipment not suitable for use in the presence of Degree of safety of... -
Page 14: General
General 500mW rms typical Max. Audio Output (Loudspeaker) After 5 minutes continuous operation Auto shut-off Max. output Power: 25 mW rms (32Ω) Headphones Connector: 3.5mm stereo jack socket Max. applied voltage: +9Vdc IEC 6LR61 or IEC 6LP3146 Battery Type Typically, 500 x 1 minute examinations Battery Life Height 140mm, Depth 27mm, Width 74mm Size... -
Page 15: Electromagnetic Compatibility
WARNING: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the D920/D930, including cables specifi ed by the manufacturer. Otherwise, degradation of the performance of this equipment could result. - Page 16 Guidance and Manufacturer’s declaration - electromagnetic immunity The Doppler is intended for use in the electromagnetic environment specifi ed below. The customer or the user of the Doppler should assure that it is used in such an environment. Compliance Electromagnetic Environment - Immunity Test IEC 60601 test level level...
- Page 17 Guidance and Manufacturer’s declaration - electromagnetic immunity The Doppler is intended for use in the electromagnetic environment specifi ed below. The customer or the user of the Doppler should assure that it is used in such an environment. Compliance Immunity Test IEC 60601 test level Electromagnetic Environment - guidance level...
- Page 18 Recommended separation distances between portable and mobile RF communications equipment and the Doppler The Doppler is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. the customer or user of the Doppler can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Doppler as recommended below, according to the maximum output power of the communications equipment.
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Page 19: End Of Life Disposal
End of Life Disposal This symbol signifi es 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. -
Page 20: Warranty & Service
Warranty & Service Huntleigh Healthcare Ltd. standard terms and conditions apply to all sales. A copy is available on request. These contain full details of warranty terms and do not limit the statutory rights of the consumer. Service Returns If for any reason Dopplex unit has to be returned, please: •... - Page 21 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...
- Page 22 Huntleigh Healthcare Ltd. 35 Portmanmoor Road, Cardiff, CF24 5HN, United Kingdom T: +44 (0)29 20485885 F: +44 (0)29 20492520 sales@huntleigh-diagnostics.co.uk www.huntleigh-diagnostics.com Registered No: 942245 England & Wales. Registered Office: ArjoHuntleigh House, Houghton Hall Business Park, Houghton Regis, Bedfordshire, LU5 5XF ©Huntleigh Healthcare Limited 2003-2018...
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