Huntleigh Dopplex Ability USER MANUAL

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Table of Contents

1. Safety ................................................................................. 4

1.1 Warnings .................................................................................................4

1.2 Residual Risks .......................................................................................5

1.3 Patient Applied Parts ............................................................................. 5

2. Infection Control ................................................................. 6

3. Intended Use ...................................................................... 6

3.1 User Requirements ................................................................................6

4. Limitations of Use / Contraindications .............................. 7

5. Preliminar y Checks ............................................................ 9

6. Initial Set-up ....................................................................... 10

6.1 Battery Re-Connection ..........................................................................10

6.2 Setting the Language ............................................................................11

6.3 Battery Conditioning .............................................................................11

7. Use Environment ............................................................... 12

8. Line (Mains) Power Operation ............................................ 13

8.1 Fuses .......................................................................................................13

9. Battery Operation ............................................................... 14

10. Product Identiﬁ cation ....................................................... 15

10.1 Front Panel .............................................................................................15

10.2 Rear Panel .............................................................................................. 15

10.3 Base ........................................................................................................ 16

10.4 Product Labelling ...................................................................................16

11. System Connection ........................................................... 18

11.1 USB Port .................................................................................................18

12. Operation ......................................................................... 19

12.1 Getting Started ...................................................................................... 19

12.2 Loading Paper ........................................................................................ 20

12.3 User Settings ..........................................................................................21

12.3.1 System Settings .....................................................................................................21

12.4 Making a Measurement .........................................................................25

12.4.1 Patient Preparation.................................................................................................25

12.4.2 Setting Patient Type ..............................................................................................26

12.4.3 Fitting the Cuffs ......................................................................................................26

12.4.4 Performing the test .................................................................................................30

12.4.5 Viewing the results ................................................................................................30

12.4.6 Example reports .....................................................................................................31

12.4.7 Paper Low Indication .............................................................................................32

12.4.8 Report Storage Guidance ......................................................................................32

12.5 Switching the Unit Off ...........................................................................32

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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...........................................................................................38

14.2 Cleaning and Disinfecting Cuffs and Tubing ......................................39

14.3 Cleaning and Disinfecting the Ability Unit ..........................................40

15. Maintenance ..................................................................... 40

16. Accessories ...................................................................... 41

16.1 Carry bag ................................................................................................41

16.2 Roll Stand ...............................................................................................42

17. Speciﬁ cations .................................................................. 45

17.1 Equipment Classiﬁ cation ..................................................................... 45

17.2 Performance ...........................................................................................45

17.3 General ...................................................................................................46

17.4 Environmental ........................................................................................46

17.5 Standards Compliance ..........................................................................46

17.6 Batteries .................................................................................................47

17.7 Accessories ........................................................................................... 47

18. Electromagnetic Compatibility ........................................ 48

18.1 Electrostatic Discharge .........................................................................51

19. End of Life Disposal .......................................................... 52

20. Warranty & Service .......................................................... 53

Table of Contents

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1. Safety

Before using this equipment, please study this manual

Safety

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

Symbols

carefully and familiarize 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.

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 ﬂ ammable anesthetics.

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.

WARNING: If this product is connected to another item of electrical equipment, it is important that the system is fully compliant with IEC60601-1:2005.

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.

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WARNING: When conﬁ guring 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 identiﬁ ed by the proximity of this symbol.

1.3 Patient Applied Parts

As deﬁ ned in IEC60601-1:2005, the patient applied parts of the dopplex Abillity are the four dual chamber cuffs.

Safety

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2. Infection Control

WARNING: Before ﬁ tting 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. ACCVAS-016.

Refer to Section 12.4 for sleeve and cuff ﬁ tting 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. They must be disposed of as infectious clinical waste.

3. Intended Use

Infection Control / Intended Use

Dopplex Ability is intended to be used on all patients considered to be at risk of having, or developing peripheral arterial disease (PAD).

Dopplex Ability is intended for the rapid measurement of ankle-brachial pressure index (ABPI) or ankle-brachial index (ABI) in adults and pulse volume recording (PVR) / volume plethysmography.

Ability is suitable for use in woundcare assessment, for assessing symptomatic PAD, and as a screening device for PAD.

It may also be used on patients with venous or arterial ulcers prior to the application of compression therapy.

Dopplex Ability can be used on patients with unilateral lower limb amputation.

3.1 User Requirements

Dopplex Ability is intended for use only by a suitably qualiﬁ ed 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 qualiﬁ ed clinician in conjunction with a clinical assessment.

It is recommended that all users familiarize themselves with the information provided in this user manual and in the enclosed Training Pack before using this product.

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4. Limitations of Use / Contraindications

CAUTION: Federal law restricts this device to sale by or on the order of a physician or a properly licensed practitioner.

CAUTION: Dopplex Ability provides just one indicator of vascular condition. This should be used as part of an holistic approach to venous or arterial 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.

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 ﬂ at

• patients under 18 years of age

Limitations of Use / Contraindications

CAUTION: False high ABI results may occur in diabetic patients when the leg cuff is unable to compress calciﬁ ed distal arteries on the ankle effectively.

CAUTION: Ensure all cuffs are ﬁ tted correctly and aligned on limbs according to the instructions. Measurement error may occur if cuffs are ﬁ tted incorrectly.

CAUTION: The ABI Classiﬁ cation thresholds, which are adjustable via the front panel function buttons, should only be adjusted by a suitably qualiﬁ ed clinician.

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Limitations of Use / Contraindications

CAUTION: Always observe ABI value, not only classiﬁ cations, as marginal results could be overlooked.

CAUTION: Do not sterilize 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.

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5. Preliminary Checks

Contents (supplied with each system)

Item Item Item

1 x dopplex Ability Allen Key 1 x Training pack: 4 x Adult Dual Chamber

Cuffs with Colour Coded tubes

1 x Box Infection Control Barrier Sleeves

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.

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 -4°F (-20°C) to +122°F (+50°C), and relative humidity of 10% to 90% non-condensing.

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

1 x Mains Cable

(Training CD, Instructions for Use CD, Quick Reference Guide, FAQ’s, PVR Application, Battery Leaﬂ et, Registration Leaﬂ et)

Preliminary Checks

If it is necessary to store the unit after a period of use, it is advisable to ﬁ rst 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.

For long term storage, the internal Real Time Clock backup battery should also be removed. Refer to the service manual for details.

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6. Initial Set-up

6.1 Battery Re-Connection

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

Initial Set-up

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-ﬁ t the battery cover and replace the securing screw with the allen key provided. DO NOT OVERTIGHTEN!

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4. Connect the unit to the mains supply (1) and switch it on by pressing the On/Off button

(2).

6.2 Setting the Language

When switched on for the ﬁ rst time, the operating language must be selected. The language selection screen will be displayed.

SET LANGUAGE

English Deutsch Francais Italiano

English

CONFIRM

Press to highlight the required language. Press to Select.

6.3 Battery Conditioning

Initial Set-up

V1.2

Immediately after the language has been selected, the battery conditioning screen will be displayed.

Note: The battery must be conditioned before the unit is ﬁ rst used. If the battery is

Battery Conditioning

(Do Not Disconnect From Mains)

not conditioned, battery operation will be unreliable.

To start battery conditioning, press the centre softkey.

When conditioning is complete, the unit will switch off automatically. It can then be switched on and used from mains supply or battery.

Note: Battery conditioning can take up to 10 hours to complete.

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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.

Use Environment

Use in strong sunlight should be avoided as display visibility is greatly reduced. 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.

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.

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8. Line (Mains) Power Operation

Dopplex Ability is supplied with a plug-in mains lead, ﬁ tted with a 3 pin line plug. 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 Fuses

Internal fuses are ﬁ tted in both the live and neutral lines. Correctly rated fuses must be ﬁ tted as below:- T1AH 250VAC

Fuses must only be replaced by a suitably qualiﬁ ed technician.

Line (Mains) Power Operation

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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 ﬁ lls from left to right. The time required to fully charge a completely discharged battery is approximately two hours.

Battery Operation

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 ﬂ ash 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.

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. Product Identiﬁ cation

10.1 Front Panel

V1.2

1 On/Off button 2 Display 3 Function Buttons 4 Colour Coded Tubes

10.2 Rear Panel

Product Identiﬁ cation

1 Mains Inlet 2 Printer Cover 3 COM Port Connector (USB)

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10.3 Base

Product Identiﬁ cation

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 deﬁ nitions in BS EN 60601-1:1990

Applied parts (cuffs) are type BF according to the deﬁ nitions in BS EN 60601-1:1990

Functional Earth Power On/Off

Alternating current (AC)

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.

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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

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

ANSI/AAMI ES60601-1 (2005, 3rd ed.) CAN/CSA-C22.2 No 60601-1 (2008) UL60601-1, CAN/CSA C22.2 No 601.1

Use By Do Not Reuse

YYYY-MM

50°C

Temperature

-10°C

Limitations

Serial Number

Manufacturer

Keep Dry Do not use hook

This way up Contents can be recycled

E364052

Medical Electrical Equipment

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 veriﬁ es that the manufactured product continues to comply with UL’s safety requirements.

25°C

Upper Limit of Temperature

REF

Reference Number

Date of Manufacture

YYYY-MM

Product Identiﬁ cation

PVC

Max 90% RH

Returnable packaging

PVC FREE Does not contain PVC

Limits of Relative Humidity

LATEX

Cardboard packaging can be recycled.

LATEX FREE Does not contain Latex

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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.

System Connection

2 Medical equipment must comply with IEC60601-1, or equivalent. 3 The conﬁ gured 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 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 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 conﬁ guring a medical system, and is therefore responsible for ensuring that the system complies with the requirements of IEC60601-1:2005; clause 16. If there is any doubt as to whether your system complies, consult the technical service department or your local Huntleigh representative.

11.1 USB Port

Dopplex Ability is ﬁ tted 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 qualiﬁ ed personnel. For technical speciﬁ cations 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.

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

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12. Operation

12.1 Getting Started

1. Connect to mains

supply.

V1.2

Operation

2. Press .

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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12.2 Loading Paper

Operation

1. Grasp printer door ﬁ rmly and pull gently backwards.

2. Insert paper roll as shown and close printer door. A ‘click’ will be

heard when door is fully engaged.

3. To tear paper, hold ﬁ rmly 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 ﬂ at 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 ﬁ rmly downwards. A positive ‘click’ will be heard as each pivot snaps into place.

Note: Standard (Plain) paper will allow approximately 55 printouts. Label paper will allow approximately 35 printouts.

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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.

Operation

1. Press

24/11/10 14:34

to access the system settings.

24/11/10 14:34

Exit Contrast Set time/date Paper type

2. Press to scroll through the setting menus. Press to select.

a. Contrast: Press

to set Contrast value. Press to

Conﬁ rm.

24/11/10 14:34

Exit Contrast Set time/date Paper type

Exit Contrast Set time/date Paper type Audio volume Classification Waveforms Language Battery conditioner Demo Mode Cuff Leak Test Service menu

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b. Time/Date: Press to Conﬁ rm. Press to set Time.

Operation

24/11/10 14:34

Exit Contrast Set time/date Paper type

SET TIME

12 24

SET DATE FORMAT

dd/mm/yy mm/dd/yy yy/mm/dd

SET TIME

10 36

SET DATE

dd/mm/yy

26/03/09

Press to set Date format. Press to Conﬁ rm. Press to set Date.

Note: As the Time and Date are printed on the printout, the time and date must be set correctly.

c. Paper Type: Press

24/11/10 14:34

Exit Contrast Set time/date Paper type

to select Paper type. Press to Conﬁ rm.

Plain

Label

Note: “Label” type is the adhesive backed thermal label paper (see Section

16.6)

d. Audio Volume: Press to select required volume. Press

24/11/10 14:34

Contrast Set time/date Paper type Audio volume

to Conﬁ rm.

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e. Classiﬁ cation: Press to select Classiﬁ cation ON or OFF. Press

to Conﬁ rm.

Press Press

24/11/10 14:34

Set time/date Paper type Audio volume Classification

CAUTION: The ABI Classiﬁ cation thresholds, which are adjustable via the front panel function buttons, should only be adjusted by a suitably qualiﬁ ed clinician.

f. PVR Waveforms: Press Press

24/11/10 14:34

Paper type Audio volume Classification Waveforms

to change thresholds.

to Conﬁ rm.

Classification on

Classification off

to select Waveforms ON or OFF.

to Conﬁ rm.

Waveforms on

Waveforms off

Incompressible

Normal

Mild

Moderate

Severe

1.31

0.91

0.81

0.51

Operation

g. Language: Press to select required Language. Press

24/11/10 14:34

Audio volume Classification Waveforms Language

to Conﬁ rm.

SET LANGUAGE

English Deutsch Francais Italiano

English

CONFIRM

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Operation

h. Battery Conditioner: Press to select Battery Conditioner. Press

24/11/10 14:34

Classification Waveforms Language Battery conditioner

Battery Conditioner

(Do Not Disconnect from Mains)

to Conﬁ rm.

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. 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 artiﬁ cial waveforms.

24/11/10 14:34

Waveforms Language Battery conditioner Demo Mode

j. Cuff Leak Test: Refer to Troubleshooting Section.

k. Service Menu: Press

to select Service Menu. You will require a 4 digit access code to enter this function. Please see Service Manual for further details.

24/11/10 14:34

Battery conditioner Demo Mode Cuff Leak Test Service Menu

xxx

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12.4 Making a Measurement

12.4.1 Patient Preparation

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.

Fitting Infection Control Barrier Sleeves

Arm

Leg

Operation

Note: Remove any trapped air before tightening cuffs.

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12.4.2 Setting Patient Type

1. Press .

Operation

2. Press to select patient normal or amputee mode. Press

to Conﬁ rm.

11/03/08 14:34

3. 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 ﬁ tted correctly and aligned on limbs according to the instructions. Measurement error may occur if cuffs are ﬁ tted incorrectly.

Please Note! For clarity purposes, the following illustrations show limbs un-clothed. Cuffs can be ﬁ tted and measurements taken over thin clothing such as pantyhose, thin shirts and thin socks. Cuffs cannot be ﬁ tted over sweaters or pants.

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Correct Cuff Placement

REDRIGHT ARM

Operation

YELLOW -

LEFT ARM

BLACKRIGHT ANKLE

Adult

22cm - 36cm (8.7

- 14.2Ý) Max

22cm - 36cm (8.7Ý - 14.2Ý)

Min

18cm - 28cm (7.1

Min

Adult

Ý)

- 14.2

22cm - 36cm (8.7

Max

GREEN -

LEFT ANKLE

Adult

)

Ý

Ý - 11.0

Max

Adult

18cm - 28cm (7.1Ý

Max

Adult

- 11.0

Ý

Max

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Arm

Infection Control Barrier Sleeve

Note: Remove any trapped air before tightening cuffs.

Operation

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

Adult

22cm - 36cm (8.7

- 14.2

Ý

)

Max

Infection Control Barrier Sleeve

Note: Remove any trapped air before tightening cuffs.

Adult

18cm - 28cm (7.1

Min

Ý - 11.0

)

Ý

Max

Ensure strap is ﬁ tted on top of the foot. (Over anterior tibial artery)

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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

Diagnostic Products Division

Email: [email protected]

www.huntleigh-diagnostics.com

Made in UK

ACC-VAS-023

LATEX

0088

18cm - 28cm (7.1

Adult

- 11.0Ý)

Min

Operation

Ensure the cuffs are not

Huntleigh Healthcare Ltd

35 Portmanmoor Road Cardi, CF24 5HN. UK Tel: +44(0) 29 2048 5885

PVC

rotated around the limb.

Measurement error or failure to take correct measurement may occur if cuffs are ﬁ tted incorrectly

Ensure the cuffs are ﬁ tted in the correct orientation.

Measurement error or failure to take correct

Min

18cm - 28cm (7.1Ý - 11.0Ý)

Max

Adult

measurement may occur if cuffs are ﬁ tted incorrectly

Note: Take great care to ensure that the tubing is not kinked or obstructed in any way. Do not touch cuffs or tubing when measurement is in progress.

Note: The patient must lie supine, be relaxed, remain still, and refrain from talking, coughing etc.

Note: Always brief the patient before the test, explaining that the cuffs will tighten, and that the test will take approximately 3 minutes to complete.

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12.4.4 Performing the test

Patient Brieﬁ ng

The patient should always be briefed on what to expect during the test to avoid unnecessary distress. This should describe how the cuffs will inﬂ ate, and then

Operation

after a short delay the arm cuffs will both tighten, followed by tightening of the ankle cuffs. After approximately three minutes all cuffs will deﬂ ate and the test will be complete.

They should be advised that the test can be stopped at any time if they ﬁ nd 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.

CAUTION: Always remain with the patient and monitor test progress.

Test In Progress

IMPORTANT!

Press to stop

the test at any time.

12.4.5 Viewing the results

1. The results will be displayed within 3 minutes.

122

120

129 126

1.06

ABI

1.03

2. Press to print results.

min

353025

3. Press

to show PVR waveforms.

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4. Press to return to previous screen or to print PVR waveforms.

Operation

5. Press

122

129 126

120

to view the ABI Classiﬁ cation.

1.06

ABI

1.03

Normal

1.06

ABI

1.03

6. Press to print or to start a new test.

CAUTION: Always observe ABI value, not only classiﬁ cation, 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

Name.........................................

.....................................................

ID ................................................

.....................................................

Comments ..............................

.....................................................

120

124

11/03/08 14:34

136

1.10

Normal

ABI

134

1.08

Normal

771AXXXXXXXX-XX

V2.220

Name.........................................

.....................................................

ID ................................................

.....................................................

Comments ..............................

.....................................................

120

124

11/03/08 14:34

136

1.10

Normal

ABI

134

1.08

Normal

771AXXXXXXXX-XX

V2.220

Note: Always annotate patient information on report.

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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:-

Operation

No Paper

12.4.8 Report Storage Guidance

Store in a cool dry place. Do not expose to sunlight, temperatures greater than 100°F (38° C), relative humidity over 80%, or place in contact with adhesives, adhesive tapes or plasticizers such as those found in all pvc page protectors. It is recommended that reports are photocopied for optimum storage lifetime.

12.5 Switching the Unit Off

Press and hold button for approximately 3 seconds to switch the unit off.

Page 33

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 qualiﬁ ed technician should be consulted. Before attempting trouble-shooting, 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. Mains input fuses blown Unit will not turn on Connect to live power source Printout blank Paper inserted incorrectly Battery Low symbol showing Connect to the power source Battery does not hold charge Select ‘Battery Conditioner’ menu

(section 12.3.1) or replace battery

No results produced Check all tubes and cuffs and repeat

test.

Only one ankle cuff inﬂ ates Check patient type is correctly set

(See section 12.4)

Display not clear Contrast setting is incorrect (See

section 12.3.1)

Printout not clear on label paper Check setting of paper type (See

section 12.3.1) Paper printout jams Incorrect paper ﬁ tted Unit will not ﬁ t to roll stand Ensure mounting plate is ﬁ tted

correctly Cuff takes a long time to inﬂ ate Check air ﬁ lter or check cuffs for

leaks

Troubleshooting

Page 34

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 / Right Arm Cuff - Not Connected

• Left / Right Ankle Cuff - Not Connected

Troubleshooting

• Arm Cuffs / Ankle Cuffs - Not Connected Recommended Action: Check that the cuffs are properly connected, and are

ﬁ tted 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 / Right Arm Cuff - Leak Detected

• Left / Right Ankle Cuff - Leak Detected

• Arm Cuffs / Ankle Cuffs - Leak Detected

Recommended Action: Run the Cuff Leak test in Section 13.2.

Inﬂ ation Problem

If any cuff fails to inﬂ ate correctly, one of the following messages is displayed:-

• Left / Right Arm Cuff - Inﬂ ation Problem

• Left / Right Ankle Cuff - Inﬂ ation Problem

• Arm Cuffs / Ankle Cuffs - Inﬂ ation Problem Recommended Action: Check cuffs are ﬁ tted correctly and tubing is

not kinked or obstructed. If problem persists, refer to Service Manual for diagnostic test procedures.

Left Arm Cuff - Not Connected Refer To User Manual

Left Arm Cuff - Leak Detected Refer To User Manual

Left Arm Cuff - Inflation Problem Refer To User Manual

Excess Pressure

If excess pressure is detected in any cuff, one of the following messages is displayed:-

Left Arm Cuff - Excess Pressure

• Left / Right Arm Cuff - Excess Pressure

• Left / Right Ankle Cuff - Excess Pressure

• Arm Cuffs / Ankle Cuffs - Excess Pressure Recommended Action: Ensure the cuffs are not obstructed and are free

to inﬂ ate properly. Do not squeeze the cuffs during tests, or allow them to become trapped, e.g. against a wall or similar hard surface.

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 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 insufﬁ cient to completely occlude bloodﬂ ow, the systolic pressure value will be replaced by:-

“- - -”

and the corresponding ABI value will be replaced by:

“- .- -”

For the ankles, this indicates a possible incompressible artery, or that systolic pressure is greater than 205 mmHg.

For the arms, this indicates that systolic pressure may be less than 80 mmHg, or greater than 230 mmHg.

Recommended Action: Follow local clinical protocols for patient referral.

Unable to Calculate Systolic Pressure

If the software algorithms are unable to calculate a systolic pressure, the systolic value will be replaced by:

“ ? ”

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” screen.

Recommended Action: A possible cause is patient movement or incorrectly ﬁ tted cuffs, so a repeat test can be performed after checking cuffs and asking the patient to remain as still as possible. Note: When performing repeat tests on the same patient, allow at least 5 minutes for stabilisation between tests.

Internal Fault AAA:XXXX Refer To Service Manual

124

- - 196

120

- - -

134 136

- - -

124

134

120

CANNOT MEASURE

REPEAT TEST

-.--

ABI

1.10

-.--

ABI

-.--

1.08

ABI

-.--

Troubleshooting

Page 36

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.

Troubleshooting

2. Open the cuffs and lay them ﬂ at on a suitable surface.

3. Connect the unit to a mains supply and switch on.

4. Select the Setup menu (

5. Scroll down to Cuff Leak Test and press accept ( ).

6. Press accept (

7. The cuffs will be inﬂ ated to a test pressure, and then deﬂ ated. Do not touch the cuffs during the test .

8. The test result will be displayed as Pass or Fail for each ankle channel.

9. Repeat for the remaining pair of cuffs.

) to begin the test.

Page 37

13.3 Guidance for Reliable Performance

To improve the reliability of the results, the following points should be noted:

• Cell/smart phones etc, must be at least 4 feet away from the unit.

• The couch should be separated from adjacent walls etc. as pressure on the arms or cuffs must be avoided.

• Check that the clothing is not too thick. The cuffs can be applied over thin shirts, socks or pantyhose. If in doubt, remove the socks.

• Always brief the patient before the test, explaining that the cuffs will tighten, and that the test will take approximately 3 minutes to complete.

• The patient’s arms must be supported by the couch.

• The patient’s arms must be completely relaxed during the test and not pulled tight against the body.

• The patients heels must be supported on the couch and not be allowed to overhang the end.

• The cuffs must have the correct tension – a snug ﬁ t (taut but not tight)

• The arm sense chamber must be located just below the elbow on the largest diameter part of the forearm. The connecting strap between the two chambers should not be ﬂ at.

• The patient must lie supine, be relaxed, remain still, and refrain from talking, coughing etc.

• The operator must not talk to the patient – this always prompts responses from the patient.

• The operator must not touch the cuffs or knock the tubing during the test.

• When performing repeat tests on the same patient, allow at least 5 minutes for stabilization between tests.

Troubleshooting

Page 38

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

Care and Cleaning

order a replacement.

Please ensure that you check with your facility’s local infection control policy and medical equipment cleaning procedures.

Observe warnings and guidance on cleaning ﬂ uid labelling regarding use and personal protective equipment (PPE).

Do not use abrasive cloths or cleaners.

Do not use automatic washers or autoclaves.

Do not use Phenolic detergent based disinfectants, solutions containing cationic surfactants, ammonia based compounds or perfumes and antiseptic solutions.

If detergent or disinfectant wipes are used ensure that excess solution is squeezed from the wipe prior to use.

Always switch off Products and disconnect from the AC supply before cleaning and disinfecting.

Do not allow any ﬂ uid to enter the products and do not immerse in any solution.

Always wipe off disinfectant using a cloth dampened with clean water.

Page 39

14.2 Cleaning and Disinfecting Cuffs and Tubing

Before ﬁ tting the cuffs to the patient, evaluate the cross-contamination risk according to the deﬁ nitions in the tables below:

1. 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:

Deﬁ nition Procedure

Normal use or low risk situations including patients with intact skin and no known infection.

2. Medium / High Risk

Deﬁ nition Procedure

The patient has a known infection, or skin is not intact.

1. Clean with soft cloth and a mild, neutral detergent @ 40°C (104°F)

2. Disinfect using a 70% isopropyl alcohol wipe or chlorine releasing agent @ 1000ppm available chlorine

3. Wipe with a cloth dampened in clean water.

4. Completely dry with a clean lint-free cloth

Because of the nature of the cuff materials, effective cleaning and disinfection in high risk situations is not practical. Therefore, infection control barrier sleeves are recommended as an alternative, to prevent cuff contamination.

Care and Cleaning

Do not iron Do not use phenol or phenol-derivative

disinfectant.

Do not dry clean Do not tumble dry.

Do not machine wash. Do not immerse tubeset in water.

CAUTION: Do not allow any ﬂ uid to enter the cuff tubing.

CAUTION: Do not use abrasive cleaning methods.

CAUTION: Do not use alternative cleaning agents or methods as permanent damage is likely.

CAUTION: Inspect cuffs after cleaning and prior to use.

Page 40

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 ﬂ uids using a clean dry cloth.

1. The unit can be wiped with a soft cloth dampened with a mild

detergent solution in water. Avoid the electrical contacts, apertures and connectors.

2. Wipe any ﬂ uids from the surface of the product using a clean dry

cloth.

3. Wipe with a cloth dampened in 70% Isopropyl Alcohol.

4. Completely dry with a clean, dry lint free cloth.

Care and Cleaning / Maintenance

If the product becomes contaminated, follow the ‘low risk’ cleaning and disinfection instructions given above, but use a more concentrated chlorine agent at 10,000 ppm available chlorine.

Warning: Repeated and unnecessary use of concentrated solutions will result in damage to the product. Do not allow sodium hypochlorite solutions to come into contact with metal parts.

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: [email protected] ).

Suitable test equipment and a full range of spare parts are also available. Please refer to service manual for further information and part numbers.

Page 41

16. Accessories

16.1 Carry bag

Side compartments

for 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.

Compartment in top ﬂ ap

can store Infection Control

Barrier Sleeves

Accessories

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. To avoid damage to the mains cable, it should be unplugged from the unit.

Page 42

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 ﬁ tted

Accessories

and removed safely and quickly.

Note: To use the roll stand, a mounting plate (Part No ACC-VAS-012) is required to be ﬁ tted to the base of the Ability unit.

1. With the mounting plate ﬁ tted to the ability unit, slide the unit

sideways, ensuring that the plate is aligned with the grooves in the roll stand support surface.

Mounting Plate

Slide Unit Sideways onto the roll stand.

Ensure unit is ﬁ tted in the correct orientation.

Page 43

2. Locate the lock pin and pull downwards so that the Ability unit can be

positioned centrally on the support surface.

Pull lock pin downwards

3. Release the lock pin and ensure it locates in the hole in the mounting

plate. This can be veriﬁ ed by attempting to slide the Ability unit sideways. It must be securely locked into position.

Release lock pin.

Ensure lock pin is properly engaged

Accessories

CAUTION: Ensure that the Ability unit is securely ﬁ tted to the roll stand and that the lock pin is properly engaged.

Page 44

Adjusting the Platform Height

The black knob on the roll stand upright must be slowly rotated anti-clockwise

whilst supporting the platform.

CAUTION: Do not allow the platform to drop, as product damage and personal injury may result.

Accessories

Lower the platform to the desired height and rotate the black knob clockwise to lock it ﬁ rmly into position.

CAUTION: Ensure the platform is ﬁ rmly locked into position before use.

Cuff Storage

The cuffs should be stored in the basket provided on the roll stand. The tubing should be ﬁ tted to the tubing supports located immediately beneath the support platform.

CAUTION: Do not store other equipment in the basket.

Supports for cuff tubing

CAUTION: Ensure the tubing is securely supported before moving the roll stand.

Brakes

Two of the roll stand castors are ﬁ tted with brakes. Apply the brakes when the stand is stationary.

Page 45

17. Speciﬁ cations

17.1 Equipment Classiﬁ cation

Type of protection against electric shock.

Degree of protection against electric shock

Mode of operation. Continuous Degree of protection

against harmful ingress of particles and/or water.

Degree of safety of application in the presence of a ﬂ ammable anaesthetic

17.2 Performance

Systolic Pressure Range

ABI Dopplex Ability provides valid ABI results for at least

PVR Dopplex Ability provides ﬁ ltered PVR waveforms from the

Maximum Cuff Pressure

Class II and Internally powered equipment with a functional earth terminal, which provides a ground path for the internal mains ﬁ lter.

Type BF - equipment with an applied part.

Speciﬁ cations

IP30

Equipment not suitable for use in the presence of a FLAMMABLE ANAESTHETIC MIXTURE WITH AIR, OXYGEN OR NITROUS OXIDE

Arms : 80 - 220 mmHg Ankles : 55 - 205 mmHg

80% of the patients tested. Valid results consist of both compressible vessels (where Dopplex Ability agrees with the Doppler method to ± 0.28 for the 95% limits of agreement), and incompressible vessels.

ankles with -3dB cut-off frequencies at 0.35 Hz and 10 Hz.

230 mmHg

Page 46

17.3 General

Supply voltage 100 to 240V ~ 50-60Hz. Fuse Type T1AH 250V Power input 3-80 VA USB Connector : Mini Type: 1, full speed, 12 Mbps.

Speciﬁ cations

Printer Integral 58 mm, thermal Paper Roll width : 2.25” (58mm) nominal,

Size Height 6.3” (160mm), Depth 10.2” (240mm), Width 10.3”

Weight 6.6 lbs (3Kg) Service Life 7 years

17.4 Environmental

Operating Storage

50°F to 95°F (10°C to 35°C)

10% to 90% (non condensing)

860mb to 1060mb Pressure 860mb to 1060mb Paper Shelf Life Up to 5 years if stored in the original wrapping in a

Safety : Fully isolated

Roll diameter : 1.6” (40mm)

(260mm)

Temperature range -4°F to 122 °F

(-20°C to 50°C)

Relative Humidity 10% to 90% (non

condensing)

dark place at an approximate relative humidity of 50% and a temperature below 77°F (25°C).

17.5 Standards Compliance

IEC60601-1: 2005 Medical Electrical Equipment Part 1

EN60601-1-2: 2001 [collateral standard]

EN10993-1: 2009 & AC: 2010

EN62366 :2008 General requirements for basic safety and essential

IEC 62304: 2006 Medical device software - Software life cycle

BS EN 980:2008 Symbols for use in the labelling of medical devices

General Requirements for Safety General requirements for safety: Electromagnetic

compatibility Biological Evaluation of Medical Devices; Guidance

on selection of tests

performance - Collateral standard: Usability

processes.

Page 47

17.6 Batteries

Chemistry Voltage Compliance Part No

Rechargeable Battery pack

Real time clock back up battery

NiMH 12V UL2054 SP-771332

Lithium Manganese Dioxide

3V SP-771514

17.7 Accessories

Item Part No.

Roll Stand* with integrated storage basket and tube management (a)

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 Adult Right Arm Cuff - 8.5”-14” (22-36cm) ACC-VAS-023 Adult Right Ankle Cuff - 7”-11” (18-28cm) ACC-VAS-024 Adult Left Arm Cuff - 8.5”-14” (22-36cm) ACC-VAS-025 Adult Left Ankle Cuff - 7”-11” (18-28cm) ACC-VAS-026 Large Adult Cuff Set - arm and ankle cuffs ACC-VAS-011 Large Adult Right Arm Cuff - 13”-18” (34-46cm) ACC-VAS-007 Large Adult Right Ankle Cuff - 9.5”-14” (24-35cm) ACC-VAS-008 Large Adult Left Arm Cuff - 13”-18” (34-46cm) ACC-VAS-009 Large Adult Left Ankle Cuff - 9.5”-14” (24-35cm) ACC-VAS-010 Infection Control Barrier Sleeves (Disposable, box of 100) ACC-VAS-016

Printer Paper

Standard Thermal Paper (Pack 5) Adhesive Backed Thermal Label Paper (Pack 5)

ACC-VAS-013

ACC-VAS-017 ACC-VAS-019

Speciﬁ cations

(a) + (d) - Items must be purchased together (b) + (c) + (d) - Items must be purchased together

*Do not use dopplex Ability with other non-approved accessories.

**Always use the Fixing plate when attaching the dopplex Ability to approved accessories.

Page 48

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 conﬁ gured 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

Electromagnetic Compatibility

on different branch circuits

WARNING: The use of accessories, transducers and cables other than those speciﬁ ed, 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 conﬁ guration in which it will be used .

Guidance and Manufacturer’s declaration - electromagnetic emissions

The dopplex Ability is intended for use in the electromagnetic environment speciﬁ ed 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

RF emissions CISPR 11

Harmonic emissions IEC 61000-3-2

Voltage ﬂ uctuations / ﬂ icker emissions IEC 61000-3-3

Group 1

Class B

Class A

Complies

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.

Page 49

Guidance and Manufacturer’s declaration - electromagnetic immunity

The dopplex Ability is intended for use in the electromagnetic environment speciﬁ ed below. The customer or the user of the dopplex Ability should assure that it is used in such an environment.

Immunity Test

Conducted RF IEC 61000-4-6

Radiated RF IEC 61000-4-3

IEC 60601 test

level

3 Vrms 150kHz to 80MHz

3 V/m 80MHz to 2.5MHz

Compliance

level

3V/m

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.

d = 1.2 √ P

d = 1.2 √ P d = 2.3 √ P

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 ﬁ xed 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:

80MHz to 800MHz 800MHz to 2.5GHz

Electromagnetic Compatibility

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 reﬂ ection from structures, objects and people.

Field strengths from ﬁ xed 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 predicted theoretically with accuracy. To assess the electromagnetic environment due to ﬁ xed RF transmitters, an electromagnetic site survey should be considered. If the measured ﬁ eld 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 performance is observed, additional measures may be necessary, such as re-orienting or relocating the dopplex Ability.

Over the frequency range 150kHz to 80kHz, ﬁ eld strengths should be less than 3V/m.

Page 50

Electromagnetic Compatibility

Guidance and Manufacturer’s declaration - electromagnetic immunity

The Dopplex Ability is intended for use in the electromagnetic environment speciﬁ ed below. The customer or the user of the Dopplex Ability should assure that it is used in such an environment.

Immunity Test

Electrostatic discharge (ESD)

IEC 61000-4-2

IEC 60601 test

level

± 6 kV contact ± 8 kV air

Compliance

level

± 6 kV contact ± 8 kV air

Electromagnetic Environment

- guidance

Floors should be wood, concrete or ceramic tile. If ﬂ oors are covered with synthetic material, the relative humidity should be at least 30%.

Electrical fast transient burst

± 2 kV for power supply lines

Mains power quality should be that of a typical commercial or hospital environment.

IEC 61000-4-4

Surge IEC 61000-4-5

Voltage dips, short interruptions and voltage variations on power supply input lines

IEC 61000-4-11

± 1 kV for input/ output lines

± 1 kV line(s) to line(s)

± 2 kV line(s) to earth

<5 % U

(>95 % dip in Ur ) for 0,5 cycles

40 % U

(60 % dip in Ur ) for 5 cycles

± 1 kV for input/ output lines

± 1 kV line(s) to line(s)

± 2 kV line(s) to earth

<5 % U

(>95 % dip in Ur ) for 0,5 cycles

40 % U

(60 % dip in Ur ) for 5 cycles

Mains power quality should be that of a typical commercial or hospital environment.

Mains power quality should be that of a typical commercial of hospital environment. If the user of the Dopplex Ability requires continued operation during power mains interruptions, it is recommended that the Dopplex Ability is powered from an

Power frequency (50/60Hz) magnetic ﬁ eld

70 % U

(30 % dip in Ur ) for 25 cycles

<5 % U

(>95 % dip in Ur ) for 5 s

3 A/m 3 A/m Power frequency magnetic ﬁ elds

70 % U

(30 % dip in Ur ) for 25 cycles

<5 % U

(>95 % dip in Ur ) for 5 s

uninterruptible power supply or battery.

should be at levels characteristic of a typical location in a typical commercial or hospital

IEC 61000-4-8

is the a.c. mains voltage prior to the application of the test level.

NOTE U

environment.

Page 51

Recommended separation distances between portable and mobile RF communications

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.

Rated maximum output power of

transmitter

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 reﬂ ection from structures, objects and people.

equipment and the dopplex Ability

Separation distance according to frequency of transmitter

150kHz to 80MHz

d = 1.2 √ P

80MHz to 800MHz

800MHz to 2.5GHz

d = 1.2 √ P

d = 2.3 √ P

Electromagnetic Compatibility

18.1 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.

Page 52

19. End of Life Disposal

End of Life Disposal

Page 53

20. Warranty & Service

a) ARJOHUNTLEIGH INC. HEREBY DISCLAIMS ALL EXPRESS OR IMPLIED WARRANTIES (INCLUDING BUT NOT LIMITED TO WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE) AND ANY AGREEMENTS, REPRESENTA TIONS, AFFIRMATIONS, OR WARRANTIES, WHETHER ORAL OR WRITTEN, MADE BY ANY AGENT, EMPLOYEE OR REPRESENTATIVE OF ARJOHUNTLEIGH INC., UNLESS SPECIFICALLY SET FORTH IN THIS PARAGRAPH. ARJOHUNTLEIGH INC. SHALL NOT BE LIABLE FOR BREACH OF CONTRACT ARISING FROM ANY DEFECT IN MATERIAL OR WORKMANSHIP OF THE GOODS. ALL LEGISLATION RELATING TO EXPRESS AND IMPLIED WARRANTIES OR OTHER OBLIGATIONS ON THE PART OF ARJOHUNTLEIGH INC. THAT MAY BE LAWFULLY EXCLUDED ARE HEREBY EXCLUDED.

b) Notwithstanding the foregoing, ArjoHuntleigh Inc.’s sole warranty is that the Goods shall be free from defects in material and workmanship for a period of one (1) year, following delivery of such Goods to the original purchaser; provided that the Goods were used in an appropriate and reasonable manner during such period and provided further that ArjoHuntleigh Inc. shall be in no event be liable to Customer for defective Goods if: (i) the Goods are damaged in the course of shipping; (ii) any defect is caused wholly or to any material extent by customer’s negligence, misuse, failure to use the Goods properly or use of the Goods in conjunction with any accessory not approved for use with the Goods by ArjoHuntleigh Inc.; (iii) the Goods are damaged as a result of improper maintenance, failure to follow manufacturer’s instructions, including without limitation those on washing and cleaning, or failure to follow necessary routine maintenance procedures; or (iv) the Goods are altered, repaired or dismantled other than with manufacturer’s written authorization using its approved procedures or by any party other than manufacturer’s properly qualiﬁ ed and trained technicians.

c) Customer must provide written notice to ArjoHuntleigh Inc., within said warranty period of any defect in the Goods. Upon ArjoHuntleigh Inc.’s written request, Customer must return such Goods adequately packed (in their original packing) and fully insured to ArjoHuntleigh Inc.#’s place of business and shall be responsible for all shipping costs incurred therein. Customer’s exclusive remedy and ArjoHuntleigh Inc.’s exclusive liability for any claim for loss, damage or destruction resulting from any defects in materials and workmanship shall be limited to repair, service, adjustment or replacement (at ArjoHuntleigh Inc.’s option) of any nonconforming or defective Goods. ArjoHuntleigh Inc. will have a reasonable time to repair, service or replace such Goods. Any Goods returned to ArjoHuntleigh Inc. which are found not to be defective in breach of the warranty in Subsection (b) above, shall be returned to the Customer in the manner described in this subsection.

Warranty & Service

d) IN NO EVENT SHALL ARJOHUNTLEIGH INC. BE LIABLE FOR ANY INCIDENTAL OR CONSEQUENTIAL LOSSES OR DAMAGES (INCLUDING BUT NOT LIMITED TO ECONOMIC LOSS, LOSS OF PROFITS OR SPECIAL DAMAGES) ARISING OUT OF OR INCURRED BY CUSTOMER IN CONNECTION WITH THE PURCHASE OF ARJOHUNTLEIGH INC.’S GOODS EVEN IF ARJOHUNTLEIGH INC. HAS BEEN ADVISED OR HAS KNOWLEDGE OF THE POSSIBILITY OR EXTENT OF SUCH DAMAGES SUFFERED OR INCURRED BY CUSTOMER OR ANY END USER AS A RESULT OF OR IN CONNECTION WITH ANY BREACH OF THESE TERMS AND CONDITIONS BY ARJOHUNTLEIGH INC. OR ANY TORT (INCLUDING BUT NOT LIMITED TO STRICT LIABILITY OR NEGLIGENCE) COMMITTED BY ARJOHUNTLEIGH INC., ITS AGENTS OR REPRESENTATIVES IN CONNECTION WITH THESE TERMS AND CONDITIONS OR ANY CONTRACT WITH CUSTOMER FOR THE SUPPLY OF GOODS.

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Warranty & Service

e) Customer shall not create, directly or indirectly, any warranty obligations on the part of ArjoHuntleigh Inc. to the customers of Customer, and in particular, without limiting the foregoing, Customer agrees not to pass on to its customers any warranties beyond or in addition to those given by ArjoHuntleigh Inc. to Customer hereunder. Where the Customer is a dealer in the Goods, it shall be responsible for the labor cost of all repairs and ArjoHuntleigh Inc. shall be responsible for providing all repair parts during said one (1) year. The dealer shall provide written veriﬁ cation of warranty repairs including the original invoice number, date of purchase, description of repairs, name of its customer and date of sale to such customer.

f) Customer shall be deemed to have full knowledge of the nature and properties of the Goods ordered and of any hazards they involve and the proper treatment, storage and handling thereof. Any technical advice furnished by ArjoHuntleigh Inc. or its representatives or agents is given only on the basis that it is followed at the Customer’s own risk

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 certiﬁ cate (or other statement declaring that the product has been cleaned) to the outside of the package.

• Call Huntleigh Service Dept. in San Antonio, TX for a return authorization number.

Huntleigh Healthcare Ltd reserve the right to return product that does not contain a decontamination certiﬁ cate.

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The dopplex Ability 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, Ability and Huntleigh are registered trademarks of Huntleigh

Technology Ltd. 2011.

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