MD2-SD2 User Manual

CONTENTS CONTENU, INHALT, CONTENUTO, INNEH ÅLL, INHOUD, CONTENIDOS

BATTERY PILE, BATTERIE, BATTERIA, BATTERI, BATTERIJ, BATERÍA

1

Jugular Vein VP4HS, VP5HS

2

Subclavian Vein VP4HS, VP5HS

3

Fetus OP2HS, OP3HS

4

Femoral Vein VP4HS, VP5HS

5

Great Saphenous Vein VP5HS,VP8HS, EZ8

6

7

11 Subclavian Artery VP4HS, VP5HS

10

8

Posterial Tibial Artery VP8HS, EZ8

9

Vertebral Artery VP4HS, VP5HS

10 Carotid Artery VP5HS, VP8HS, EZ8

13 Ulnar Artery VP8HS, EZ8

11

2

14 Radial Artery VP8HS, EZ8

12 13

3

Small Saphenous Vein VP8HS, EZ8 Posterior Tibial Veins VP8HS, VP10HS, EZ8

12 Brachial Artery VP8HS, EZ8

9

1

4

14 16

17 15

5

6 8

16 Digital Artery VP8HS, VP10HS, EZ8 17 Penis VP8HS, VP10HS, EZ8 18 Popliteal Artery VP5HS

18

7

15 Femoral Artery VP4HS, VP5HS

20

19

19 Metatarsal Artery VP8HS, VP10HS, EZ8 20 Dorsalis Pedis Artery VP8HS, VP10HS, EZ8

Do not use Dopplers in the presence of flammable gases such as anaesthetic agents.

Refer to diagram on inside front cover for Doppler Measuring sites and Recommended Probes.

Do not use in the sterile field unless additional barrier precautions are taken.

During Use An automatic noise reduction feature operates on low level signals to improve sound quality.

Do Not : Immerse in any liquid, use solvent cleaner, use high temperature sterilising processes (such as autoclaving), use E-beam or gamma radiation sterilisation.

To replace battery see diagram. After Use 1.

Press and release the On/Off button. If you forget to switch the unit off, it will automatically shut-off after 3 minutes.

2.

Refer to the cleaning section before storing or using the unit on another patient.

Do not use in the eye.

3.

If outputs 1 and 2 are used simultaneously, the system should comply with EN606011-1. Any equipment connected to outputs 1 or 2 should comply with EN60601-1, EN60950, EN60065, EN60335 or EN61010.

Store unit together with probe and accessories in the soft carry case provided.

The control unit and the body of the probe are robust and require no special handling. However, the probe tip is delicate and must be handled with care.

This product contains sensitive electronics, therefore, strong radio frequency fields could possibly interfere with it. This will be indicated by unusual sounds from the loudspeaker. We recommend that the source of interference is identified and eliminated.

Cleaning

Do not dispose of batteries in fire as this can cause them to explode.

Remove excess gel before parking the probe. Clean with a damp cloth impregnated with mild detergent. Do not allow fluid to seep into either unit.

Do not attempt to recharge normal dry-cell batteries. They may leak, cause a fire or even explode.

For disinfection use a soft cloth with Sodium Hypochlorite 1000ppm or alcohol.

Dopplex Dopplers are screening tools to aid the healthcare professional and should not be used in place of normal vascular or fetal monitoring. If there is doubt as to vascularity or fetal well-being after using the unit, further investigations should be undertaken immediately using alternative techniques.

Alcohol saturated swabs can be used on the probe tip. Please be sure to check your local control of infection policies, or any equipment cleaning procedures. Phenolic, detergent based disinfectants containing cationic surfactants, ammonia based compounds, or antiseptic solutions such as Steriscol or Hibiscrub should never be used on any part of the system.

We recommend that exposure to ultrasound should be kept As Low As Reasonably Achievable - (ALARA guidelines). This is considered to be good practice and should be observed at all times.

Coupling Gel

Means Attention consult this manual. Refer to safety section.

Use water based ultrasound gel ONLY. 3

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GENERAL OPERATION & MAINTENANCE

WARNING/CAUTIONS & SAFETY

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OPERATING INSTRUCTIONS VASCULAR

OPERATING INSTRUCTIONS VASCULAR

Gain Control

The Multi Dopplex II/Super Dopplex II Dopplers (MD2/SD2) will select vascular mode when a vascular probe is connected to the control unit. In this mode, bi-directional blood flow rate and direction are indicated on bar graphs (4 levels in each direction) and blood flow is audible in the loudspeaker. Probe frequency is displayed together with the bar graphs.

To cope with the wide variety of signals detectable using your MD2/SD2, a gain control allows you to optimise the bar-graph display and increase the height of the waveforms. Using the Mode button on the MD2 (Gain button for SD2), gain can be set to x1, x2, x4, x8.

Clinical Use

Connection to Printa II (MD2 Only)

Apply a liberal amount of gel on the site to be examined. Place the probe at 45° to the skin surface over the vessel to be examined. Adjust the position of the probe to obtain the loudest audio signal. High pitched pulsatile sounds are emitted from arteries while veins emit a non-pulsatile sound similar to a rushing wind.

Hard copy printing is automatically selected when the plug of the interface buffer box is inserted into the RS232 socket on the top panel of the MD2. Printing is then initiated by using the Start/Stop button. Connection to Software (MD2 Only)

For best results, keep the probe as still as possible once the optimum position has been found. Adjust the audio volume as required.

The MD2 can be connected to the Reporter Software Package, via the RS232 interface. Dopplex Reporter software package is available as an accessory. Communicating is then initiated by using the Start/Stop button.

Waveform Recording (MD2 only) Separated waveform outputs are provided in analogue and digital formats. Analogue signals are provided for connection to a single channel chart recorder giving a combined bi-directional waveform, or to a dual channel recorder for separate forward and reverse flow waveforms. (Pin-out details on request).

Probes Five probes are available for vascular examinations: VP4HS

4MHz ±1% for deep lying vessels VP5HS 5MHz ±1% for deep lying vessels and oedematous limbs VP8HS 8MHz ±1% for peripheral vessels VP10HS 10MHz ±1% for specialist superficial applications. EZ8 8MHZ ±1% "Widebeam" for peripheral vessels.

Digital signals are provided via the RS232 port for printing separate waveforms on a Dopplex Printa II or for communicating with Dopplex Reporter software package. Cal Function The baseline and sensitivity of the chart recorder can be set up using the Cal function. This generates a zero velocity baseline and a sequence of bi-directional pulses as shown below: Cal Pulses

4

Mode Selection

Obstetric mode is automatically selected when an obstetric probe (OP2HS/OP3HS) is connected. In this mode, MD2 provides fetal heart rate (FHR) display with 3 operating modes, and outputs FHR for printing on the Printa II. The SD2 in obstetric mode provides audio only.

Use of Manual Mode

Clinical Use

1.

Apply a liberal amount of gel to the abdomen. Place the faceplate of the probe flat against the abdomen above the symphysis pubis. Adjust the probe to obtain an optimum audio signal ideally by angling the probe around. Avoid sliding it over the skin.

Press and hold Start/Stop button and immediately count the audible heart beats, counting the first beat as the button is pressed. The LCD displays the flashing clock symbol and the FHR reading is shown as three dashes.

2.

Release the Start/Stop button immediately on the count of 10 (i.e. After nine beat intervals). The MD2 will automatically calculate the derived FHR averaged over the 10 beat period and display the result. This rate value is retained until the measurement is repeated or the unit is switched off. If the button is held for a period less than about 3 seconds the display will clear the previous rate value and reset.

In early pregnancy a full bladder may improve sound detection. In later pregnancy the best signals are generally located higher on the abdomen. The fetal heart sounds like a galloping horse at approximately twice the maternal rate. A wind-like sound is heard from the placenta. Standard Mode - MD2 Only In this mode the FHR, averaged over 4-heart beats, is displayed on the 3-digit readout. The LCD displays an outline heart symbol.

Probes

Smoothed Mode - MD2 Only

OP2HS OP3HS

This mode is used to obtain more stable heart rate readings. In this mode, FHR is averaged over 8 beats. The LCD displays a solid heart symbol. Manual Mode - MD2 Only This mode is used when a fetal heart beat is audible in the loudspeaker or headphones but, due to noise or a low signal level, the MD2 cannot reliably calculate the heart rate. In this mode, the heart rate can be manually counted over a period of 10 audible heart beats (see below). The MD2 will automatically calculate and display the derived FHR on the LCD. The LCD displays a clock symbol.

5

2MHz ±1% 3MHz ±1%

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OPERATING INSTRUCTIONS OBSTETRICS

OPERATING INSTRUCTIONS OBSTETRICS

ENGLISH

WARRANTY & SERVICE Huntleigh Healthcare's standard terms and conditions apply to all sales. A copy is available on request. These contain full details of warranty terms and do not limit the statutory rights of the consumer. Service Returns If for any reason your Dopplex Unit is being returned, please: 1.

Clean the product, as described in the cleaning section.

2.

Pack it in suitable packing.

3.

Attach the decontamination certificate (or other written statement declaring that the product has been cleaned) to the outside of the package.

4.

Mark the package "Service Department Multi/Super Dopplex II".

UK For further details refer to the NHS document HSG(93) 26. For service, maintenance and any questions regarding this, or any other Huntleigh Healthcare Dopplex product, please contact: Huntleigh Healthcare Ltd Diagnostic Products Division 35 Portmanmoor Road Cardiff CF24 5HN UK Tel : +44 (0)29 20485885 Fax: +44 (0)29 20492520 Or your local distributor.

Manufactured in the UK by Huntleigh Healthcare Ltd. As part of the ongoing development programme the company reserves the right to modify specifications and materials of the Multi Dopplex II or Super Dopplex II without notice. Huntleigh Healthcare Ltd - A Huntleigh Technology PLC company. Dopplex, Huntleigh and 'H' logo are registered trademarks of Huntleigh Technology PLC 2004. ©Huntleigh Healthcare Ltd. 2004

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ENGLISH

TECHNICAL SPECIFICATION Product Name:

Multi/Super Dopplex® II

Model No.:

MD2/SD2

Physical Characteristics:

Weight : 295 gms Height : 140mm

Max. Audio Output:

Width : 74mm

500mW rms typical

Max Headphones Output Power: 25 mW rms (32 Auto Shut-O Off: RS232 (MD2 Only):

Depth : 27mm

headphones) (max. applied voltage +9Vdc)

After 10 minutes continuous operation or 3 minutes no signal RS232C, 8 pin sub-miniature DIN connector (max. applied voltage +5Vdc)

Waveform Outputs (MD2 only): Analogue:

Zero crosser, 3.5V full scale per channel (forward and reverse). Conversion factor automatically adjusted to give full scale outputs at ±0.1% (±10%) of probe frequency (e.g. ±8kHz for VP8)

Digital:

Data formatted to interface with Printa II or Recorder software running on compatible computer. Conversion factors automatically set as per analogue outputs.

CAL Function:

Automatic sequence of CAL levels set to ±0.05% (±10%) and ±0.1% (±10%) of probe frequency (e.g. ±4kHz & ±8kHz for VP8) with zero baseline at start and end of sequence.

Battery Type Recommended: 9 volt alkaline manganese (e.g. MN1604) Battery Life:

Typically, 250 x 1 minute examinations

Complies With:

BS5724: Part 1 : 1989, IEC 601-1: 1988, EN60601-1

FHR Performance :

Standard Mode Range - 60-210bpm Resolution - 1bpm Averaging - 4 beats Accuracy - ±3bpm

Smoothed Mode Range - 60-210bpm Resolution - 1bpm Averaging - 8 beats Accuracy - ±3bpm

Manual Mode Range - 60-210bpm Resolution - 1bpm Averaging - 10 beats Accuracy -±3bpm (excluding user error)

IEC601-1 1 Classification:

Type of shock protection Degree of shock protection Protection against water ingress Degree or safety in presence of flammable gases Mode of operation

Operating Temperature:

+10°C to +30°C

Storage Temperature:

-10°C to +40°C

Internally powered equipment Type B equipment Ordinary equipment Equipment not suitable for use in presence of flammable gases Continuous

Medical Devices Directive 93/42/EEC

7

HEALTHCARE

MANUFACTURED & DISTRIBUTED IN THE UK BY:

35, Portmanmoor Road, Cardiff CF24 5HN UK Tel: +44 (0) 29 204 85885 Fax: +44 (0) 29 204 92520

DISTRIBUTED IN THE USA BY: Huntleigh Healthcare Inc 40 Christopher Way Eatontown New Jersey 07724-3327 Tel: (800) 223-1218 Fax: (732) 578-9889

Email: [email protected] www.huntleigh-diagnostics.co.uk

DISTRIBUTED IN GERMANY BY:

DISTRIBUTED IN AUSTRALIA BY:

Huntleigh GmbH Im Hülsenfeld 19 40721 Hilden Germany Tel: 00 492 103 971100 Fax: 00 492 103 971180

Huntleigh Healthcare Pty Ltd PO BOX 330 Hamilton Hill Western Australia 6963 Tel: 00 618 9337 4111 Fax: 00 618 9337 9077

Medical Devices Directive 93/42/EEC

© Huntleigh Healthcare 2004 ® and H logo are registered trademarks of Huntleigh Technology PLC.

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