Related Manuals for Huntleigh Dopplex Ability DA100
Summary of Contents for Huntleigh Dopplex Ability DA100
- Page 1 INSTRUCTIONS FOR USE Dopplex Ability ® Dopplex Ability Auto ABI Monitor ® 771955EN-2 11/2023...
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Page 2: Table Of Contents
Dopplex Ability - English Table of Contents 1. Safety .......................4 Warnings ....................... 4 Residual Risks ..................... 4 Patient Applied Parts ................... 4 Service Life ......................4 2. Infection Control ....................5 3. Intended Use ....................5 User Requirements ....................5 4. Limitations of Use / Contraindications ............6 Model Description .................... - Page 3 12.4.2 Setting Patient Type ....................... 21 12.4.3 Fitting the Cuffs ....................... 21 12.4.4 Performing the test ......................24 12.4.5 Viewing the results ......................25 12.4.6 Example reports ......................26 12.4.7 Paper Low Indication * ....................26 12.4.8 Report Storage Guidance * ..................... 26 12.5 Switching the Unit into Standby .................
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Page 4: Safety
This has been defined as the minimum time period during which the device is expected to remain safe and suitable to meet its intended use, and all risk control measures remain effective. Huntleigh Healthcare Ltd’s commitment is that the expected service life for this Device has been defined as 7 years. -
Page 5: Infection Control
Infection Control WARNING: Before fitting cuffs to the patient, evaluate the cross contamination risk. For medium/high risk situations, where the patient has a known infection or skin is not intact, use an infection control barrier sleeve with aseptic technique. Infection control barrier sleeves are available as an accessory, Part No. ACC-VAS-016. Refer to Section 12.4 for sleeve and cuff fitting instructions. Refer to Section 14.2 for care and cleaning instructions. -
Page 6: Limitations Of Use / Contraindications
Limitations of Use / Contraindications WARNING: Dopplex Ability is not intended to be used in the following patient conditions: • a suspected or present Deep Vein Thrombosis (DVT) • severe congestive cardiac failure or similar condition • gangrene • recent skin graft •... -
Page 7: Preliminary Checks
* www.huntleigh-diagnostics.com Delivery Inspection Huntleigh Healthcare Ltd 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 Healthcare Ltd is informed as soon as possible. -
Page 8: Initial Set-Up
Initial Set-up Battery Re-Connection * Note The dopplex Ability is supplied with the internal battery disconnected. To re-connect the battery, please see instructions below. Invert the unit and remove the battery cover by removing the securing screw using the allen key provided. -
Page 9: Setting The Language
Connect the unit to the mains supply (1) and switch it on by pressing the On/Standby button (2). V1.2 Setting the Language When switched on for the first time, the operating language must be selected. The language selection screen will be displayed. SET LANGUAGE English English... -
Page 10: Use Environment
Use Environment Dopplex Ability is suitable for use in hospital, primary care and community settings. It must not be used outdoors, or in any environment where it may come into contact with water. This equipment is not suitable for domestic use. A couch, or similar level support surface is required for the patient to lie on, and the main unit requires a table or similar for support. -
Page 11: Battery Operation
Battery Operation * The internal battery, when fully charged, provides enough power for approximately ten ABI measurements. An on-screen indicator shows the state of charge at all times. Battery charging takes place when the unit is connected to the line (mains) power. During battery charging, the battery symbol fills from left to right. -
Page 12: 10. Product Identification
10. Product Identification 10.1 Front Panel V1.2 On/Standby button Display Function Buttons Colour Coded Tubes 10.2 Rear Panel Mains Inlet Printer Cover (depending on model) COM Port Connector (USB) Instructions For Use... -
Page 13: Base
10.3 Base Battery Cover Battery Cover Retaining Screw Slide plate Mounting boss Air Filter 10.4 Product Labelling Note: Product labelling should be read from a distance no greater than 0.5m. Dopplex Ability is Class II, double insulated according to the definitions in IEC60601-1:2012 Applied parts (cuffs) are type BF according to the definitions in IEC60601-1:2012 Functional Earth Power On/Standby... - Page 14 ArjoHuntleigh AB, Hans Michelsensgatan 10 211 20 Malmö, Sweden Manufactured By: Huntleigh Healthcare Ltd. 35 Portmanmoor Road, Cardiff, CF24 5HN, United Kingdom T: +44 (0)29 20485885 sales@huntleigh-diagnostics.co.uk www.huntleigh-diagnostics.com The UL mark indicates that Dopplex Ability complies with Underwriters Laboratories requirements for safety, and is subject to UL’s follow up services program which verifies that...
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Page 15: System Connection
IEC60601-1. This may be achieved by using a medical grade isolating transformer. Suitable types are available via Huntleigh sales agents. Anyone who connects additional equipment to signal input or signal output parts of the system is configuring a medical system, and is therefore responsible for ensuring that the system complies with the requirements of IEC60601-1:2012;... -
Page 16: Operation
Operation 12.1 Getting Started 1. Connect to mains supply. 2. Press V1.2 3. Connect colour coded tubing Note Use the function buttons below the display to access and change the system setting and patient measurement menus. Function Buttons V1.2 Instructions For Use... -
Page 17: Loading Paper
• Standard (Plain) paper will allow approximately 55 printouts. • Label paper will allow approximately 35 printouts. CAUTION Only use paper approved by Huntleigh. 12.3 User Settings 12.3.1 System Settings CAUTION Do not apply excessive pressure to the buttons, or use a sharp implement, such as a pen to press the buttons, as damage may result. - Page 18 2. Press to scroll through the setting menus. Press to select. a. Contrast: Press to set Contrast value. Press to Confirm. 24/11/10 14:34 Exit Contrast Set time/date Paper type b. Time/Date: Press to Confirm. Press to set Time. 24/11/10 14:34 SET TIME SET TIME Exit...
- Page 19 e. Classification: Press to select Classification ON or OFF. Press to Confirm. Press to change thresholds. Press to Confirm. 24/11/10 14:34 Incompressible 1.31 Set time/date Normal Classification on Paper type 0.91 Mild Audio volume Classification off 0.81 Classification Moderate 0.51 Severe CAUTION The ABI Classification thresholds, which are adjustable via the front panel function buttons, should only be adjusted by a suitably qualified clinician.
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Page 20: Making A Measurement
i. Demo Mode: Press to select Demo Mode. The Demo Mode shows results that have been pre-stored in the Ability. This mode is useful at exhibitions without the need for a full test. The printout is clearly marked ‘Demo Mode’ and shows pre-stored results and artificial waveforms. 24/11/10 14:34 Waveforms Language... -
Page 21: Setting Patient Type
12.4.2 Setting Patient Type 1. Press 11/03/08 14:34 Press to select patient normal or amputee mode. Press to Confirm. Press to progress to cuff placement screen. 12.4.3 Fitting the Cuffs Position the cuffs on the patient. CAUTION: Ensure all cuffs are fitted correctly and aligned on limbs according to the instructions. Measurement error may occur if cuffs are fitted incorrectly. Note: For clarity purposes, the following illustrations show limbs un-clothed. Cuffs can be fitted and measurements taken over thin clothing such as tights, thin shirts and thin socks. Cuffs cannot be fitted over jumpers or trousers. - Page 22 Correct Cuff Placement RED- YELLOW - LEFT RIGHT ARM BLACK- GREEN - LEFT RIGHT ANKLE ANKLE Adult 22cm - 36cm (8.7˝ - 14.2˝ ) Instructions For Use...
- Page 23 Infection Control Barrier Sleeve Note: Remove any trapped air before tightening cuffs. Place strap with white line over the inside of the arm (Over brachial artery) Place distal chamber just below elbow, on largest diameter part of the forearm. Leg/Foot Infection Control Barrier Sleeve Note: Remove any trapped air before tightening cuffs.
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Page 24: Performing The Test
Incorrect Cuff Placement Ensure the cuffs are not rotated around the limb. Measurement error or failure to take correct measurement may occur if cuffs are fitted incorrectly Ensure the cuffs are fitted in the correct orientation. Measurement error or failure to take correct measurement may occur if cuffs are fitted incorrectly Note •... -
Page 25: Viewing The Results
IMPORTANT! Press to stop the test at any time. 12.4.5 Viewing the results The results will be displayed within 3 minutes. 1.06 1.03 35 30 25 Press to print results.* Press to show PVR waveforms. Press to return to previous screen or to print* PVR waveforms. -
Page 26: Example Reports
12.4.6 Example reports 11/03/08 14:34 Name....................1.10 ID ..................... Normal Comments ............................1.08 ............. Normal ............. V2.220 771AXXXXXXXX-XX 11/03/08 14:34 Name....................1.10 ID ..................... Normal Comments ............................1.08 ............. Normal ............. V2.220 771AXXXXXXXX-XX Note: Always annotate patient information on report. -
Page 27: Troubleshooting
Troubleshooting This section gives some of the more common problems encountered during use together with possible causes. If the problem cannot be located after consulting the table in this section, the dopplex Ability should be switched off, disconnected from mains power source and a qualified technician should be consulted. Before attempting troubleshooting, verify that the power cable is properly connected to both the dopplex Ability and the mains power source. - Page 28 Inflation Problem If any cuff fails to inflate correctly, one of the following messages is displayed:- • Left / Right Arm Cuff - Inflation Problem Left Arm Cuff - Inflation Problem Refer To User Manual • Left / Right Ankle Cuff - Inflation Problem •...
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Page 29: Cuff Leak Test
Unable to Calculate Systolic Pressure If the software algorithms are unable to calculate a systolic pressure, the systolic value will be replaced by: 1.08 “ ? ” and the corresponding ABI value will be replaced by: -.-- “- .- -” If this occurs on both ankles, the results display will be replaced by the “CANNOT MEASURE”... -
Page 30: Guidance For Reliable Performance
13.3 Guidance for Reliable Performance To improve the reliability of the results, the following points should be noted: • Mobile/smart phones etc, must be at least one metre away from the unit. • The couch should be separated from adjacent walls etc. as pressure on the arms or cuffs must be avoided. -
Page 31: 14. 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 32: Cleaning And Disinfecting The Ability Unit
It is recommended that the Ability unit and accessories are inspected and tested at least annually. Full details are included in the Service Manual which can be obtained from Huntleigh Healthcare Service Department, quoting the unit serial number (email: service@huntleigh-diagnostics.co.uk ). -
Page 33: Accessories
Accessories 16.1 Carry bag Compartment in top flap can store Side com partments for Infection Control Barrier Sleeves cuff storage Central compartment for dopplex Ability A carry bag is available for the dopplex Abilty. It is highly recommended that the bag is always used whenever the unit is transported. -
Page 34: Roll Stand
16.2 Roll Stand A roll stand is available which provides a stable means of support, and a convenient means of moving the unit around within the building. Fitting the Ability Unit to the Roll Stand The roll stand support incorporates a slide mount that allows the unit to be fitted and removed safely and quickly. Note: To use the roll stand, a mounting plate (Part No ACC-VAS-012) is required to be fitted to the base of the Ability unit. - Page 35 Locate the lock pin and pull downwards so that the Ability unit can be positioned centrally on the support surface. Pull lock pin downwards Release the lock pin and ensure it locates in the hole in the mounting plate. This can be verified by attempting to slide the Ability unit sideways.
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Page 36: 17. Specifications
17. Specifications 17.1 Equipment Classification Type of protection against electric Class II and Internally powered equipment with a shock. functional earth terminal, which provides a ground path for the internal mains filter. Degree of protection against electric Type BF - equipment with an applied part. shock Mode of operation. -
Page 37: Environmental
17.4 Environmental Operating Storage 10°C to 35°C Temperature range -20°C to 50°C 10% to 90% (non condensing) Relative Humidity 10% to 90% (non condensing) 860mb to 1060mb Atmospheric Pressure 860mb to 1060mb Paper Shelf Life * Up to 5 years if stored in the original wrapping in a dark place at an approximate relative humidity of 50% and a temperature below 25°C 17.5 Standards Compliance... -
Page 38: Accessories
17.7 Accessories Item Part No. Roll Stand* with integrated storage basket and tube management (a) ACC-VAS-013 Wall Mount with optional storage basket and tube management (b) ACC-VSM-154 Utility Hook (for wall mount) (c) ACC-VSM-187 Fixing plate** (d) ACC-VAS-012 Carry Bag ACC-VAS-015 Adult Cuff Set - arm and ankle cuffs ACC-VAS-027... -
Page 39: Electromagnetic Compatibility
Electromagnetic Compatibility Make sure the environment in which dopplex Ability is installed is not subject to strong sources of electromagnetic interference (e.g. radio transmitters, mobile phones). This equipment generates and uses radio frequency energy. If not installed and used properly, in strict accordance with the manufacturer’s instructions, it may cause or be subject to interference. - Page 40 Guidance and Manufacturer’s declaration - electromagnetic immunity The dopplex Ability is intended for use in the electromagnetic environment specified below. The customer or the user of the dopplex Ability should assure that it is used in such an environment. IEC 60601 test Compliance Immunity Test Electromagnetic Environment - guidance level level Portable and mobile RF communications...
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Page 41: Electrostatic Discharge
Guidance and Manufacturer’s declaration - electromagnetic emissions The dopplex Ability is intended for use in the electromagnetic environment specified below. The customer or the user of the dopplex Ability should assure that it is used in such an environment. Emissions Test Compliance Electromagnetic Environment - guidance The dopplex Ability uses RF energy only for its internal function. -
Page 42: End Of Life Disposal
• Mark the package ‘Service Department ‘ 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. Service Department. Huntleigh Healthcare, Diagnostic Products Division, 35, Portmanmoor Rd.,... - Page 43 Is the appointed UK Responsible Person as defined in UK Medical Devices Regulations 2002 (SI 2002 No 618, as amended). For Northern Ireland (NI) CE marking will still apply until further amendment to applicable regulations. 1001071-2 Dopplex, Ability and Huntleigh are registered trademarks of Huntleigh Technology Ltd. 2011. Instructions For Use...
- Page 44 In the European Union, the user should also report the serious incident to the Competent Authority in the member state where they are located. Manufactured in the UK by Huntleigh Healthcare Ltd on behalf of; ArjoHuntleigh AB Hans Michelsensgatan 10 211 20 Malmö, Sweden...
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