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Related Manuals for Arjo Huntleigh Dopplex Ability
Summary of Contents for Arjo Huntleigh Dopplex Ability
- Page 1 INSTRUCTIONS FOR USE Dopplex Ability ® Dopplex Ability Auto ABI Monitor ® 771438EN-14 06/2022...
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Page 2: Table Of Contents
Table of Contents 1. Safety ....................4 Warnings ....................4 Residual Risks ..................5 Patient Applied Parts ................5 Service Life ..................... 5 2. Infection Control ..................6 3. Intended Use ..................6 User Requirements ................6 4. Limitations of Use / Contraindications ..........7 Model Description .................. - Page 3 12.4.7 Paper Low Indication * ................... 32 12.4.8 Report Storage Guidance * ..................32 12.5 Switching the Unit into Standby ............32 13. Troubleshooting ..................33 13.1 Error Messages ..................34 13.2 Cuff Leak Test ..................36 13.3 Guidance for Reliable Performance ............. 37 14.Care and Cleaning ................38 14.1 General Care...................
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Page 4: Safety
Safety Before using this equipment, please study this manual carefully and familiarise yourself with the controls, display features and operation. Ensure that each user fully understands the safety and operation of the unit, as mis-use may cause harm to the user or patient, or damage to the product. -
Page 5: Residual Risks
Residual Risks 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. Patient Applied Parts As defined in IEC60601-1:2005, the patient applied parts of the dopplex Abillity are the four dual chamber cuffs. Service Life 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. -
Page 6: 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. WARNING: Infection control barrier sleeves are single use devices and must not be re-used. -
Page 7: 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 8: Model Description
CAUTION: Always observe ABI value, not only classification, as marginal results could be overlooked. CAUTION: Do not sterilise the product or its accessories. The product will be damaged, and there is a risk of patient and user harm. CAUTION: If using the dopplex Ability roll stand, ensure the unit is properly locked in place, otherwise it could fall, and cause personal injury. -
Page 9: Preliminary Checks
Preliminary Checks Contents (supplied with each system) Item Item Item 1 x dopplex Ability Allen Key 1 x Training pack: (Training CD, 4 x Adult Dual Chamber 2 x Rolls Printer Paper* Instructions for Use CD, Cuffs with Colour Coded (1 x plain, 1 x label) Quick Reference Guide, tubes FAQ’s, 1 x Box Infection Control 1 x Mains Cable PVR Application, Barrier Sleeves... -
Page 10: 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. Lift the battery out, and connect the battery to the unit. 3. Replace the battery. Re-fit the battery cover and replace the securing screw with the allen key provided. DO NOT OVERTIGHTEN! * Depending on model Instructions For Use... -
Page 11: 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 Deutsch CONFIRM Francais Italiano Press to highlight the required language. Press to Select. Battery Conditioning * Immediately after the language has been selected, the battery conditioning screen will be displayed. -
Page 12: 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. Alternatively, a roll stand is available as an accessory, part number ACC-VAS-013. WARNING: It is important for safety that the use environment is well-lit to reduce the risk of persons tripping over the cables and tubes. Use is not recommended in areas that are used as access walkways. -
Page 13: Line (Mains) Power Operation
Line (Mains) Power Operation Dopplex Ability is supplied with a plug-in mains lead, fitted with a 3 pin mains plug. The cores use the European colour code : BROWN LIVE BLUE NEUTRAL GREEN/YELLOW FUNCTIONAL EARTH If it becomes necessary to fit a new mains plug take care that the wires have correct lengths, so that in the event of extreme strain, the earth wire will be the last to break. Make sure that the cable clamp secures the outer sheathing so that there is no direct strain on any individual wires at the terminals. Where the plug is fused, a 5A fuse should be fitted. Connect the power cable to the line power socket. If a good, reliable earth is not available operate the dopplex Ability from its internal battery pack *. -
Page 14: 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. The time required to fully charge a completely discharged battery is approximately two hours. When the battery reaches a critically low level of charge such that further use is not possible, the battery symbol will appear in outline, and will flash continuously. The unit will then switch off automatically when the battery is completely discharged. If the battery is disconnected for any reason, it must be conditioned immediately after re-connection. Refer to section 12.3.1 (h) for instructions. Failure to do this will result in unreliable operation from the battery. -
Page 15: 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 16: 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 BS EN 60601-1:1990 Applied parts (cuffs) are type BF according to the definitions in BS EN 60601-1:1990 Functional Earth Power On/Standby Alternating current (AC) 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. This symbol signifies that this product complies with the essential requirements of the Medical Device Directive (93/42/EEC) - Medical Device Regulation (EU/2017/745) - Page 17 WARNING: ..Indicates the possibility of death or serious injury CAUTION: ..Indicates the possibility of personal injury or material damage. Attention, consult accompanying documents / Instructions for Use Legal Manufacturer in association with the CE mark in Europe ArjoHuntleigh AB, Hans Michelsensgatan 10 211 20 Malmö, Sweden Manufactured Huntleigh Healthcare Ltd.
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Page 18: System Connection
11. System Connection WARNING: These requirements must be met when a dopplex Ability is connected to any other electrical equipment, such as a PC. 1 Non-medical equipment must comply with the relevant IEC or ISO safety standard. For Information Technology equipment, this standard is IEC950/ EN60950. Medical equipment must comply with IEC60601-1, or equivalent. 3 The configured system must comply with the requirements of IEC60601-1:2005; clause 16. If non-medical equipment (e.g. the PC or printer) with enclosure leakage currents greater than those allowed by IEC60601-1 is to be used in the patient environment (within 1.5m of the patient), the enclosure leakage currents must be brought within the limits laid down by IEC60601-1. This may be achieved by using a medical... -
Page 19: Operation
12. 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 20: Loading Paper
12.2 Loading Paper * 1. Grasp printer door firmly and pull gently backwards. Insert paper roll as shown and close printer door. A ‘click’ will be heard when door is fully engaged. To tear paper, hold firmly and tear from one edge towards the front of the unit. Note: If using label paper, ensure roll ends are smooth. If not, press end of roll onto a flat surface CAUTION Only use paper approved by Huntleigh. Note: The printer lid is designed to detach if forced. To replace, hook the two lid pivots over the metal rod and press firmly downwards. A positive ‘click’... -
Page 21: User Settings
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. 1. Press to access the system settings. 24/11/10 14:34 Exit 24/11/10 14:34 Contrast... - Page 22 b. Time/Date: Press to Confirm. Press to set Time. 24/11/10 14:34 SET TIME SET TIME Exit Contrast Set time/date Paper type SET DATE SET DATE FORMAT d d / m m/ y y d d /m m/ yy m m /d d/ yy 2 6 / 0 3 / 0 9 y y /m m/ d d Press...
- Page 23 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. f. PVR Waveforms: Press to select Waveforms ON or OFF.
- Page 24 h. Battery Conditioner: * Press to select Battery Conditioner. Press to Confirm. 24/11/10 14:34 Classification Waveforms Language Battery Conditioner Battery conditioner (Do Not Disconnect from Mains) If Battery Conditioner is selected when mains (line) power is not connected, the following message is displayed:- CONNECT Mains Power Note: Battery conditioning will take approximately 8-10 hours to complete. i. Demo Mode: Press to select Demo Mode.
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Page 25: Making A Measurement
12.4 Making a Measurement 12.4.1 Patient Preparation 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. WARNING: Do not apply cuff directly to non-intact skin. If a wound is present, ensure a suitable wound dressing is applied, followed by an infection control barrier sleeve. -
Page 26: Setting Patient Type
12.4.2 Setting Patient Type Press 11/03/08 14:34 Press to select patient normal or amputee mode. Press Confirm. Press to progress to cuff placement screen. 12.4.3 Fitting the Cuffs 1. 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. Instructions For Use... - Page 27 Correct Cuff Placement RED- YELLOW - RIGHT ARM LEFT ARM BLACK- GREEN - RIGHT ANKLE LEFT ANKLE Adult 22cm - 36cm (8.7˝ - 14.2˝ ) Instructions For Use...
- Page 28 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.
- Page 29 Foot Position Ensure patients heel is resting on the couch. Do not rest the leg on the cuff as this may affect measurement result. 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...
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Page 30: Performing The Test
12.4.4 Performing the test Patient Briefing The patient should always be briefed on what to expect during the test to avoid unnecessary distress. This should describe how the cuffs will inflate, and then after a short delay the arm cuffs will both tighten, followed by tightening of the ankle cuffs. After approximately three minutes all cuffs will deflate and the test will be complete. They should be advised that the test can be stopped at any time if they find the test unbearable. This is done by pressing the centre key below the display. The patient should also be asked to remain perfectly still during the test, and not to talk or cough etc. Press to start measurement. -
Page 31: Example Reports
Press to return to previous screen or to print* PVR waveforms. Press to view the ABI Classification. 1.06 1.06 Normal 1.03 1.03 Normal Press to print* or to start a new test. CAUTION: Always observe ABI value, not only classification, as marginal results could be overlooked. CAUTION: Systolic pressures are displayed for information only, and should not be used to form a clinical diagnosis. 12.4.6 Example reports 11/03/08 14:34 Name......... -
Page 32: Paper Low Indication
12.4.7 Paper Low Indication * When the paper approaches the end of the roll, a red marker line will be visible on the report. Approximately 5 reports with PVR or 8 reports without PVR can be printed before the paper runs out. If the print button is pressed when the paper has run out, the following message will be displayed:- No Paper 12.4.8 Report Storage Guidance * Store in a cool dry place. Do not expose to sunlight, temperatures greater than 38°... -
Page 33: Troubleshooting
13. 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. SYMPTOM POSSIBLE CAUSE / REMEDY Green power indicator not illuminated 1. Power cable not connected to live power source 2. Defective power cable 3. -
Page 34: Error Messages
13.1 Error Messages Cuff Not Connected If the user fails to connect one or more of the cuffs to the unit or the cuffs are not tensioned correctly, one of the following messages is displayed:- Left Arm Cuff - Not Connected Refer To User Manual • Left / Right Arm Cuff - Not Connected • Left / Right Ankle Cuff - Not Connected • Arm Cuffs / Ankle Cuffs - Not Connected Recommended Action: Check that the cuffs are properly connected, and are fitted snugly. Refer to section 12.4.3. Cuff Air Leak If an air leak is detected in the cuffs or tubing, one of the following messages is displayed:- Left Arm Cuff - Leak Detected Refer To User Manual •... - Page 35 Internal Fault If an internal fault is detected, the following message is displayed on the screen:- Recommended Action: The unit must be referred for Internal Fault AAA:XXXX Refer To Service Manual servicing and/or repair. Refer to contact details at the rear of this manual. Systolic Pressure Out of Measureable Range If the pressure in an occlusion chamber is insufficient to completely occlude bloodflow, the systolic pressure value will be replaced by:- -.--...
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Page 36: Cuff Leak Test
13.2 Cuff Leak Test The integral cuff leak test is able to test two cuffs at a time for leakage. Each pair of cuffs is connected to the ankle cuff connectors (black and green) on the unit. The arm cuff channels (red and yellow) are not used in this test. Procedure: 1. Connect a pair of cuffs to the ankle cuff connectors (black & green) on the unit. 2. Open the cuffs and lay them flat on a suitable surface. Connect the unit to a mains supply and switch on. Select the Setup menu ( ). 5. Scroll down to Cuff Leak Test and press accept ( Press accept ( ) to begin the test. 7. The cuffs will be inflated to a test pressure, and then deflated. Do not touch the cuffs during the test . The test result will be displayed as Pass or Fail for each ankle channel. 9. -
Page 37: 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 38: Care And Cleaning
14. Care and Cleaning 14.1 General Care All Huntleigh Products have been designed to withstand normal clinical use, however they can contain delicate components which should be handled and treated with care. 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. Please ensure that you check with your facility’s local infection control policy and medical equipment cleaning procedures. -
Page 39: Cleaning And Disinfecting Cuffs And Tubing
14.2 Cleaning and Disinfecting Cuffs and Tubing Before fitting the cuffs to the patient, evaluate the cross-contamination risk according to the definitions in the tables below: Low Risk For low-risk situations, when infection control barrier sleeves are not used, clean and disinfect the cuffs & tubing after use following the instructions below: Definition Procedure Normal use or low risk 1. Clean with soft cloth and a mild, neutral detergent situations including @ 40°C (104°F) patients with intact skin 2. Disinfect using a 70% isopropyl alcohol wipe and no known infection. or chlorine releasing agent @ 1000ppm available chlorine 3. Wipe with a cloth dampened in clean water. 4. -
Page 40: Cleaning And Disinfecting The Ability Unit
Cuff Inspection: All four cuffs should be regularly inspected. Examine the outer cuff surfaces for material damage, splitting, fraying etc. Make sure that labelling is clearly legible. Check the cuff tubing and connections for damage, splits etc. If in any doubt as to the condition, the cuff(s) should be replaced. In any case, cuffs should be replaced every two years. 14.3 Cleaning and Disinfecting the Ability Unit Always keep the external surfaces clean and free of dirt and fluids using a clean dry cloth. The unit can be wiped with a soft cloth dampened with a mild detergent solution in water. Avoid the electrical contacts, apertures and connectors. -
Page 41: Maintenance
15. Maintenance 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 ). Suitable test equipment and a full range of spare parts are also available. Please refer to service manual for further information and part numbers. Warning: Servicing cannot be performed while the unit is in use. Instructions For Use... -
Page 42: Accessories
16. Accessories 16.1 Carry bag Compartment in top flap Side compartments can store Infection Control for cuff storage Barrier Sleeves 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. The bag includes a central compartment for the main unit. The side compartments each hold two cuffs. The cuff tubing must be wrapped around the cuffs neatly, before they are placed in the bag. This helps to keep the tubing and cuffs away from the zipper and avoids damaging them. A shoulder strap is included for carrying comfort. The bag includes a separate compartment at the rear for storing paperwork and infection control barrier sleeves. -
Page 43: 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. Mounting Plate With the mounting plate fitted to the ability unit, slide the unit sideways, ensuring that the plate is aligned with the grooves in the roll stand support surface. Slide Unit Sideways onto the roll stand. - Page 44 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. It must be securely locked into position. Release lock pin.
- Page 45 CAUTION: Do not store other equipment in the basket. CAUTION: Ensure the tubing is securely supported before moving the roll stand. Brakes Three of the roll stand castors are fitted with brakes. Apply the brakes when the stand is stationary. Instructions For Use...
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Page 46: Specifications
17. Specifications 17.1 Equipment Classification Type of protection against Class II and Internally powered electric shock. equipment with a functional earth terminal, which provides a ground path for the internal mains filter. Degree of protection against Type BF - equipment with an applied electric shock part. Mode of operation. Continuous Degree of protection against IP30 harmful ingress of particles and/or water. Degree of safety of Equipment not suitable for use in the presence of application in the presence of... -
Page 47: General
17.3 General Supply voltage 100 to 240V ~ 50-60Hz. Fuse Type T1AH 250V Power input 3-80 VA Connector : Mini Type: 1, full speed, 12 Mbps. Safety : Fully isolated Printer * Integral 58 mm, thermal Paper * Roll width : 58 mm nominal, Roll diameter : 40mm Size Height 160mm, Depth 240mm, Width 260mm Weight Service Life 7 years 17.4 Environmental Operating Storage 10°C to 35°C Temperature range -20°C to 50°C 10% to 90% (non... -
Page 48: Batteries
17.6 Batteries Chemistry Voltage Compliance Part No Rechargeable NiMH UL2054 SP-771332 Battery pack * Real time clock Lithium Manganese IEC60086-4 SP-771514 back up battery Dioxide * Depending on model 17.7 Accessories Item Part No. Roll Stand* with integrated storage basket and tube management ACC-VAS-013 Wall Mount with optional storage basket and tube management (b) ACC-VSM-154... -
Page 49: Electromagnetic Compatibility
18. 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. Type-tested in a fully configured system, complies with IEC60601-1-2, 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 it does cause or is affected by interference, one or more of the following measures may correct the interference: • Reorienting the equipment • Relocating the equipment with respect to the source of interference • Moving the equipment away from the device with which it is interfering • Plugging the equipment into a different outlet so that the devices are on different branch circuits WARNING: The use of accessories, transducers and cables other than those specified, with the exception of transducers and cables sold by the manufacturer of the dopplex Ability as replacement parts for internal components, may result in increased emissions or decreased immunity of... - Page 50 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 equipment should be used no closer to any part of the dopplex Ability, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
- Page 51 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 Electromagnetic Environment - Immunity Test Compliance level level guidance Electrostatic discharge ± 8 kV contact ± 8 kV contact Floors should be wood, concrete (ESD) or ceramic tile. If floors are covered ± 15 kV air ±...
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Page 52: Electrostatic Discharge
Recommended separation distances between portable and mobile RF communications equipment and the dopplex Ability The dopplex Ability is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. the customer or user of the dopplex Ability can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the dopplex Ability as recommended below, according to the maximum output power of the communications equipment. Separation distance according to frequency of transmitter Rated maximum output power of transmitter 150kHz to 80MHz 80MHz to 800MHz 800MHz to 2.7GHz d = 1.2 √... -
Page 53: End Of Life Disposal
19. End of Life Disposal 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. Instructions For Use... -
Page 54: Warranty & Service
20. Warranty & Service Huntleigh Healthcare Diagnostic Products Division 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 the dopplex Ability has to be returned, please: • Clean the product following the instructions in this manual. • Pack it in suitable packing. • Attach 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 HSG(93)26 (UK only). - Page 55 This section is only applicable to United Kingdom (UK) market when UK marking is applied to the Arjo medical device labelling. UK Symbol: UK marking indicating conformity with UK Medical Devices Regulations 2002 (SI 2002 No 618, as amended) Figures indicate UK Approval Body supervision.
- Page 56 ArjoHuntleigh House, Houghton Hall Business Park, Houghton Regis, Bedfordshire, LU5 5XF ©Huntleigh Healthcare Limited 2011 A Member of the Arjo Family www.huntleigh-healthcare.us/ As our policy is one of continuous improvement, we reserve the right to modify designs without prior notice.
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