Huntleigh SD2 Manual de usuario
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
19
10
11
12
13
14
16
17
15
18
19
20
8
3
2
4
5
6
7
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
4
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.
5
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.
6
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)
7
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.
8
Introduction
2.3 Product Controls
12
3
4
5
6
MD2 SD2
1●●Headphone Socket
2
●Waveform Socket
●RS232 Port
3●●LCD Panel
4●●Loud-speaker
5●●On/Off Button
6●●Probe Holder
7●●Volume Control
8
●Start/Stop Button
●Cal Button
9
●Mode Button
●Gain Button
10 ●●
Battery
Compartment
11 ●●Pocket Clip
8
9
10
11
7
9
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.
10
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.
Este manual sirve para los siguientes modelos
1
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