Huntleigh SD2 Manuel utilisateur

MD2

SD2

HIGH SENSITIVITY

POCKET DOPPLERS

Table of Contents

Doppler Measurement Sites and Recommended Probes ......3

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

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

1.2 Patient Applied Parts.............................................................................5

1.3 Acoustic Safety......................................................................................5

2. Introduction .......................................................................7

2.1 Unpacking / Preliminary Checks..........................................................7

2.2 Battery Insertion / Replacement...........................................................7

2.3 Product Controls....................................................................................8

2.4 Product Labelling...................................................................................9

3. Operation ...........................................................................10

3.1 Vascular Mode........................................................................................10

3.2 Obstetric Mode ......................................................................................12

3.3 After Use.................................................................................................14

4. Care and Cleaning ..............................................................15

4.1 General Care...........................................................................................15

4.2 General Cleaning and Disinfecting .....................................................16

4.3 Cleaning and Disinfecting Patient Applied Parts................................16

4.4 Maintenance and Repair........................................................................17

5. Speciﬁcations ....................................................................18

5.1 Equipment Classiﬁcation .....................................................................18

5.2 Standards Compliance..........................................................................18

5.3 FHR Performance...................................................................................18

5.4 Waveform Outputs (MD2 Only).............................................................19

5.5 General ...................................................................................................19

5.6 Environmental........................................................................................19

6. End of Life Disposal............................................................20

7. Warranty .............................................................................21

8. Service................................................................................23

Doppler Measurement Sites and Recommended

Probes

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 Small Saphenous Vein

VP8HS, EZ8

7 Posterior Tibial Vein

VP8HS, VP10HS, EZ8

8 Posterior Tibial Artery

VP8HS, EZ8

9 Vertebral Artery

VP4HS, VP5HS

10 Carotid Artery

VP5HS, VP8HS, EZ8

11 Subclavian Artery

VP4HS, VP5HS

12 Brachial Artery

VP8HS, EZ8

13 Ulnar Artery

VP8HS, EZ8

14 Radial Artery

VP8HS, EZ8

15 Femoral Artery

VP4HS, VP5HS

16 Digital Artery

VP8HS, VP10HS, EZ8

17 Penis

VP10HS, EZ8

18 Popliteal Artery

VP5HS

19 Metatarsal Artery

VP8HS, VP10HS, EZ8

20 Dorsalis Pedis Artery

VP8HS, VP10HS, EZ8

Safety

1. Safety

Before using this equipment, please study this manual

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.

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.

Federal law restricts this device to sale by or on the order of a

licensed practitioner

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

Attention, consult this manual. Refer to safety section.

Attention, consult accompanying documents / Instructions for Use

1.1 Warnings

Do not use in the presence of ﬂammable gases such as

anesthetic agents.

Do not use in the sterile ﬁeld unless additional barrier

precautions are taken.

Do Not :

• immerse in any liquid,

• use solvent cleaner,

• use high temperature sterilizing processes (such as

autoclaving),

• use E-beam or gamma radiation sterilization.

Do not use on the eye or scrotum.

Safety

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

explode.

Do not attempt to recharge normal dry-cell batteries. They may

leak, cause a ﬁre or even explode.

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.

Any equipment connected to RS232 interface must be

compliant with IEC60601-1:2005.

Connect headphones only to the headphone socket.

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.

1.2 Patient Applied Parts

As deﬁned in IEC60601-1:2005, the patient applied parts of the Dopplex

Dopplers are the ultrasound probes.

1.3 Acoustic Safety

Continuous wave Doppler ultrasound instruments such as the MD2/SD2 have

been used extensively for medical diagnosis in the United States for over 25

years. Throughout this period, there have been no reports of adverse effects to

patients or instrument operators at the acoustic intensities recommended for

diagnostic use. Despite this highly favorable safety experience, available data

are not conclusive and the possibility remains that unwanted biological effects

might be identiﬁed in the future. Authorities therefore recommend that

ultrasound procedures be performed in accordance with the “ALARA”

principle, which states that the energy delivered to the patient should always

be kept As Low As Reasonably Achievable. With the MD2/SD2, the transmitted

acoustic power is ﬁxed and cannot be adjusted by the operator. Therefore, the

user can best observe the ALARA principle by ensuring that each examination is

medically indicated and by limiting the duration of the study to the extent

appropriate for the clinical objectives.

Safety

Acoustic intensity data (ISPTA.3) for probes available for use with the MD/SD2

are summarized in the following table. The values cited are based on

measurements in water using a calibrated hydrophone and are stated as

the estimated derated intensities. The derated intensity constitutes the most

biologically relevant parameter available since true determinations of actual

absorbed dose in tissue would require invasive measurement techniques. The

derated intensity is therefore calculated mathematically using a derating factor

consisting of a constant (the assumed attenuation coefﬁcient) and allowing

for the frequency of the probe and the distance from the probe face to the

hydrophone.

The calculated derated intensity values for the MD/SD2 compare very favorably

with previously reported acoustic safety data for Doppler ultrasound instruments

and are appropriate for all clinical applications recommended in this manual.

As the operating mode of the Dopplex range of probes is continuous wave, ISPPA

ﬁgures are not applicable.

Acoustic Output Table, Track1, Non-Auto-Scanning Mode

Model Max Value

ISPTA.3

Wo fcZsp A-6,

(Zsp)

EBD

OP2HS 55 41 2.0 2.5 1.1 1.2 x 2.5

OP3HS 55 32 3.0 2.0 1.2 1.2 x 2.5

VP4HS 92 7.5 4.0 0.8 0.14 0.365 x 0.8

VP5HS 92 8.2 5.0 0.8 0.12 0.365 x 0.8

VP8HS 92 4.0 8.0 0.48 0.026 0.215 x 0.5

EZ8 92 14.3 8.0 0.67 0.064 0.635 x 0.22

VP10HS 92 1.4 10.0 0.48 0.022 0.215 x 0.5

NOTES

1. Measurement uncertainty: varies with probe and measurement

Random - typically ±20% (max. ±32%)

Systematic - typically ±6.5% (max. ±8%)

Deﬁnition of Terms

ISPTA.3 is the derated spatial-peak, temporal-average intensity (milliwatts

per square centimeter)

Wo is the ultrasonic power (milliwatts)

fcis the center frequency (MegaHertz)

Zsp is the axial distance used to calculate the derated intensity

(centimeters)

A-6 (Zsp)is (π/4) x (X-6 x Y-6) where X-6, Y-6 are respectively the in-plane

(azimuthal) and out-of-plane (elevational) -6dB dimensions in the X-Y

plane where Zsp is found (centimeters)

EBD are the entrance beam dimensions for the azimuthal and elevational

planes (centimeters)

Introduction

2. Introduction

2.1 Unpacking / Preliminary Checks

Contents

INSTRUCTIONS

FOR USE

Delivery Inspection

Huntleigh 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 or your distributor 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 +14°F to +104°F (-10°C to

+40°C), and relative humidity of 10% to 93% non-condensing.

2.2 Battery Insertion / Replacement

123

Note: Remove the battery if the unit is not likely to be used for

some time.

Introduction

2.3 Product Controls

MD2 SD2

1●●Headphone Socket

●Waveform Socket

●RS232 Port

3●●LCD Panel

4●●Loud-speaker

5●●On/Off Button

6●●Probe Holder

7●●Volume Control

●Start/Stop Button

●Cal Button

●Mode Button

●Gain Button

10 ●●

Battery

Compartment

11 ●●Pocket Clip

Introduction

2.4 Product Labelling

Applied parts (ultrasound probes) are type B according to the

deﬁnitions in IEC60601-1:1988

Power On/Off

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.

Attention, consult this manual. Refer to safety section.

Attention, consult accompanying documents / Instructions for Use

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

Rx only Caution: Federal law restricts this device to sale by or on the order

of a licensed practitioner.

Alignment mark RS232 Interface

Volume Headphone Socket

+40°C

-10°C

Temperature

Limitations

“MAX

93%

RH”

Limits of Relative Humidity

SN Serial Number REF Reference Number

Keep Dry Do not use hook

Fragile Cardboard packaging can be

recycled.

Operation

3. Operation

Refer to diagram on page 3 for Doppler Measuring sites and

Recommended Probes.

To connect the probe, align the arrow on the connector with the slot on the

probe and push ﬁrmly.

To disconnect the probe, pull the connector sharply. DO NOT pull the cable.

Note: During use, an automatic noise reduction feature operates on low

level signals to improve sound quality.

Coupling Gel

Use water based ultrasound gel ONLY.

3.1 Vascular Mode

The Multi Dopplex II/Super Dopplex II Dopplers (MD2/SD2) will select vascular

mode when a vascular probe is connected to the control unit.

Vascular 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.

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.

Clinical Use

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.

For best results, keep the probe as still as possible once the optimum position

has been found. Adjust the audio volume as required.

Ce manuel convient aux modèles suivants

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