dopplex ABIlity Instructions for Use

14.1 Care of your Equipment ... 39 14.2 Cleaning and Disinfecting ... 39 14.3 Further Maintenance... 41

15.Accessories ... 42 15.1 Carry bag ... 42 15.2 Roll Stand ... 43

16.Specifications ... 46 16.1 16.2 16.3 16.4 16.5 16.6

Equipment Classification ... 46 Performance ... 46 General ... 47 Environmental ... 47 Standards Compliance ... 47 Accessories ... 48

Table of Contents

14.Maintenance ... 39

17.End of Life Disposal ... 49 18.Warranty & Service ... 50

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Safety

1.

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. Please keep these Instructions for Use to hand for future reference.

Symbols 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

1.1

WARNINGS WARNING: A possible explosion hazard exists if used in the presence of flammable anaesthetics. WARNING: Do not mount the unit directly above the patient. Locate the unit so that it will not cause harm should it fall.

WARNING: Do not operate the unit from the mains supply if the mains cable is damaged.

WARNING: Do not immerse any portion of the unit in water or other liquids.

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WARNING: If this product is connected to another item of electrical equipment, it is important that the system is fully compliant with EN60601-1-1.

Safety

WARNING: Use only recommended accessories listed in this manual.

WARNING: To reduce the risk of cross infection, it is recommended to always use the infection control barrier sleeves provided with the dopplex Ability. 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. WARNING: When configuring the system, consider and minimise the risk of persons tripping over the tubing and electrical cables.

1.2

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.

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Electromagnetic Compatibility

2.

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 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 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 the dopplex Ability. WARNING: The dopplex Ability should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary, the dopplex Ability should be observed to verify normal operation in the configuration in which it will be used 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

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Compliance

RF emissions CISPR 11

Group 1

RF emissions CISPR 11

Class B

Voltage fluctuations / flicker emissions IEC 61000-3-2

Class A

Harmonic emissions IEC 61000-3-3

Complies

Electromagnetic Environment - guidance The dopplex Ability uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

The dopplex Ability is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Immunity Test

IEC 60601 test level

Compliance level

Electromagnetic Environment - guidance 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.

Conducted RF IEC 61000-4-6

3 Vrms 150kHz to 80MHz

3V

Radiated RF IEC 61000-4-3

3 Vrms 80MHz to 2.5MHz

3V/m

d = 1.2 √ P d = 1.2 √ P d = 2.3 √ P

80MHz to 800MHz 800MHz to 2.5GHz

where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, a should be less than the compliance level in each frequency range b. Interference may occur in the vicinity of the equipment marked with the following symbol:

Electromagnetic Compatibility

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.

NOTE 1 At 80MHz and 800MHz, the higher frequency range 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

Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be pedicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the dopplex Ability is used exceeds the applicable RF compliance level above, the dopplex Ability should be observed to verify normal operation. If abnormal performancec is observed, additional measures may be necessary, such as re-orienting or relocating the dopplex Ability. b Over the frequency range 150kHz to 80kHz, field strengths should be less than 3V/m.

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Electromagnetic Compatibility

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 m

Rated maximum output power of transmitter

150kHz to 80MHz

80MHz to 800MHz

800MHz to 2.5GHz

W

d = 1.2 √ P

d = 1.2 √ P

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 of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1 At 80MHz and 800MHz, the separation distance for the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

2.1

Electrostatic Discharge Electrostatic discharge (ESD) is a known problem that can affect electrical equipment. If the dopplex Ability is subjected to ESD during an ABI measurement, it is possible that the measurement will be suspended. The air in all cuff chambers will be rapidly exhausted, and the unit will reset to the start-up screen. If this happens, simply perform the usual checks and repeat the test.

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Infection Control For effective control of infection, always use the infection control barrier sleeves provided with the dopplex Ability, fitted between the cuffs and the patient. These are available as an accessory, Part No.ACC-VAS-016. Refer to Section 12.4.2 for cuff fitting instructions. Always ensure the cuffs are clean before and after use. The cuffs should not be applied directly to non-intact skin.

WARNING: Infection control barrier sleeves are single use devices and must not be re-used. They must be disposed of as infectious clinical waste.

4.

Intended Use

Infection Control / Intended Use

3.

Dopplex Ability is intended for the rapid measurement of ankle-brachial pressure index (ABPI) or ankle-brachial index (ABI) in adults. It is intended to be used on all patients considered to be at risk of having, or developing peripheral arterial disease (PAD). Ability is suitable for use in woundcare assessment, for assessing symptomatic PAD, and as a screening device for PAD. Dopplex Ability is indicated for use on patients with ulcers of uncertain etiology prior to the application of compression therapy. Dopplex Ability can be used on patients with unilateral lower limb amputation.

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Limitations of Use / Contraindications

5.

Limitations of Use / Contraindications CAUTION: Dopplex Ability provides just one indicator of vascular condition. This should be used as part of an holistic approach to leg ulcer assessment together with other factors in forming the clinical diagnosis. The results from dopplex Ability must not be solely relied upon. A complete vascular assessment including clinical history and symptoms must be made before taking appropriate action. CAUTION: If the results from the dopplex Ability do not match the clinical history and symptoms of the patient, then further tests, e.g. Doppler waveform analysis, are recommended. CAUTION: Dopplex Ability is intended for use only by a suitably qualified healthcare professional. If an ABI test is undertaken by a Healthcare Support Worker, then patient selection and assessment of results must be performed by a qualified clinician in conjunction with a clinical assessment. 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 untreated leg or foot wounds dermatitis CAUTION: Dopplex Ability is not intended to be used in the following patient conditions: Cellulitis management of pulmonary hypertension patients who cannot remain still or lie flat patients under 18 years of age Severe hypertension Parkinsons Disease Severe PAD (ankle systolic pressure less than 60 mmHg) Lymphoedema Very oedematous limbs Any condition that prevents both arm pressures being measured e.g. masectomy CAUTION: False high ABI results may occur in diabetic patients when the leg cuff is unable to compress calcified distal arteries on the ankle effectively.

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CAUTION: The ABI Interpretation thresholds, which are adjustable via the front panel function buttons, should only be adjusted by a suitably qualified clinician. CAUTION: Always observe ABI value, not only interpretation, 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. WARNING: Systolic pressures are displayed for information only, and should not be used to form a clinical diagnosis.

Limitations of Use / Contraindications

CAUTION: Ensure all cuffs are fitted correctly and aligned on limbs according to the instructions, and that the patients skin is not drawn into the buckle, otherwise patient discomfort or injury could occur. Measurement error may occur if cuffs are fitted incorrectly.

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Preliminary Checks

6.

Preliminary Checks Contents (supplied with each system) Item

Item

Item

1 x dopplex Ability

1 x Instructions for Use

Allen Key

4 x Dual Chamber Cuffs with Colour Coded tubes

2 x Rolls Printer Paper (1 x plain, 1 x label)

1 x Training CD

1 x Box Infection Control Barrier Sleeves

1 x Mains Cable

1 x Quick Reference Guide

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 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 under covered conditions at a temperature between -20°C to +50°C, and relative humidity of 10% to 90% non-condensing. If it is necessary to store the unit after a period of use, it is advisable to first disconnect the battery (remove battery cover as described below and disconnect battery – DO NOT APPLY STRAIN TO THE WIRES), and remove pressure from the printer roller by opening the printer lid slightly. Then follow the above storage instructions. Note: Expected battery lifetime depends on care. With correct care, frequent charging and storage at room temperature, the battery life can be prolonged. If the unit is stored in high ambient temperatures and/or for an extended period without re-charging, it is likely that battery capacity will be degraded. Replace the battery every two years.

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Battery Connection The dopplex Ability is supplied with the internal battery disconnected. To re-connect the battery, please see instructions below. 1.

Invert the unit and remove the battery cover by removing the securing screw using the allen key provided.

2.

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!

Preliminary Checks

6.1

The battery should now be charged by connecting the unit to the mains supply for a minimum of two hours. The battery conditioning mode will automatically start when the unit is switched on (see Section 12.3.2). This will normally take 8-10 hours. When completed, the unit will switch off.

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Use Environment

7.

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. 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. Use in strong sunlight should be avoided as display visibility is greatly reduced. As the patient is required to lie flat facing upwards, strong lighting immediately above the patient may cause discomfort, so is to be avoided. The patient support surface must be wide enough for the patient to be able to allow their arms to lie comfortably at their sides. The patient’s arms must be completely relaxed during the test and not pulled tight against the body. The couch should be separated from adjacent walls etc. as pressure on the arms or cuffs must be avoided. The patients heels must be supported on the couch and not be allowed to overhang the end. The test environment should be reasonably quiet, as excessive ambient noise may prevent the patient from relaxing; an important test requirement.

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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

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. Note: To isolate the dopplex Ability from the mains or line supply, disconnect the power cable from the mains inlet at the rear of the unit.

8.1

Line (Mains) Power Operation

8.

Fuses Internal fuses are fitted in both the live and neutral lines. Correctly rated fuses must be fitted as below:T1AH 250VAC Fuses must only be replaced by a suitably qualified technician.

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Battery Operation

9.

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. It is recommended to connect the unit to line (mains) supply for at least twelve hours prior to first use, or after prolonged storage to ensure the battery is fully charged. 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. Power Save Functions When operated from the internal battery, power save functions are enabled: •

After three minutes of no keypad use, the display backlight will switch off. To switch backlight back on, simply press any of the buttons below the display once.

•

After ten minutes of no keypad use, the unit will switch off. To switch the unit back on, press the power on/off button and hold for three seconds.

Note: Any results will be lost unless a printout has been produced.

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10.1 Front Panel

2

3 1 V1.2

4

1

On/Off button

2

Display

3

Function Buttons

4

Colour Coded Tubes

Product Identification

10. Product Identification

10.2 Rear Panel

2

1 3

1

Mains Inlet

2

Printer Cover

3

COM Port Connector (USB)

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Product Identification

10.3 Base

3

4 1 2

1

Battery Cover

2

Battery Cover Retaining Screw

3

Slide plate Mounting boss

4

Air Filter

10.4 Product Labelling 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/Off

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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. 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

Product Identification

Alternating current (AC)

This symbol signifies that this product complies with the essential requirements of the Medical Devices Directive 93/42/EEC as amended by 2007/47/EC YYYY-MM

Use By

Do Not Reuse 25°C

50°C

Temperature Limitations

Upper Limit of Temperature

-10°C

SN

YYYY-MM

Serial Number Manufacturer/ Date of Manufacture

REF

YYYY-MM

Keep Dry

LATEX

Reference Number

Date of Manufacture

Do not use hook

Does not contain Latex

Limits of Relative Humidity Max 90% RH

This way up

Contents can be recycled

Returnable packaging

Cardboard packaging can be recycled.

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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.

2

Medical equipment must comply with IEC601-1/EN60601-1, or equivalent.

3

The configured system must comply with the requirements of IEC60601-1:2005; clause 16.

4

If non-medical equipment (e.g. the PC or printer) with enclosure leakage currents greater than those allowed by IEC601-1/ EN60601-1 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 IEC601-1/EN60601-1. This may be achieved by using a medical grade isolating transformer. Suitable types are available via Huntleigh sales agents.

5

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 requirements of IEC60601-1:2005; clause 16. If there is any doubt as to whether your system complies, consult the technical service department of your local Huntleigh representative.

11.1 USB Port Dopplex Ability is fitted with a standard USB port (see item 3, section 10.2 ‘Rear Panel’) for connection to a personal computer (PC). Connections to this port should only be made by suitably technically qualified personnel. For technical specifications of this interface, refer to section 16.3. It is intended to be used for software upgrade purposes, and has no functionality in normal use.

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For further information, contact the service department at the address given in section 18 of this manual.

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

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