Huntleigh SD2 User manual

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.

11
Operation
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).
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
Gain Control
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.
Connection to Printa II™ (MD2 Only)
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)
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.

12
Operation
3.2 Obstetric Mode
IMPORTANT! READ THIS SECTION BEFORE USING YOUR
Multi Dopplex.
Although the Multi Dopplex will calculate the rate as early in
pregnancy as fetal pulse signals of good quality can be
elicited, generally from about the 9th or 10th week after the last
menstrual period, fetal heart rhythm may not be sufficiently
stable to permit accurate rate computation until well after the
first trimester.
Similarly, no attempt to apply non-stress test (NST)
interpretation criteria should be made until after the 25th
week of gestation, when neurological development is usually
sufficient to obtain a reactive pattern. To be considered reactive,
two accelerations at least 15 bpm in amplitude and at least 15
seconds in duration should occur in a 10 minute period.
If the fetus is found to be non-reactive using the Multi Dopplex
hand-held sampling technique, consideration should be given to
repeating the test using a conventional fetal monitor.
The Multi Dopplex is suitable for intermittent auscultation during
the intrapartum period, but not recommended for long term
intrapartum monitoring, where Cardiotocographic equipment,
including contractions measurement capability should be
employed.
Obstetric mode is automatically selected when an obstetric probe (OP2HS/
OP3HS) is connected.
Obstetric Probes
Two probes are available for obstetric examinations:
OP2HS 2MHz ±1%
OP3HS 3MHz ±1%
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.

13
Operation
Clinical Use
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.
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.
Smoothed Mode - MD2 Only
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.
Mode Selection
Press the Mode button to select mode.

14
Operation
Use of Manual Mode
1. 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.
Connection to Printa II™ (MD2 Only)
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.
3.3 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.
3. Store unit together with probe and accessories in the soft carry case
provided.

15
Care and Cleaning
4. Care and Cleaning
4.1 General Care
All Huntleigh products have been designed to withstand normal clinical use,
however they can contain delicate components, for example the probe tip,
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
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 fluid labelling
regarding use and personal protective equipment (PPE).
Do not use abrasive cloths or cleaners.
Do not use automatic washers or autoclaves.
Phenolic detergent based disinfectants, solutions containing
cationic surfactants, ammonia based compounds or perfumes
and antiseptic solutions such as Steriscol or Hibiscrub should
never be used.
If detergent or disinfectant wipes are used ensure that excess
solution is squeezed from the wipe prior to use.
Do not allow any fluid to enter the products and do not immerse
in any solution.
Always wipe off disinfectant using a cloth dampened with clean
water.

16
Care and Cleaning
4.2 General Cleaning and Disinfecting
Always keep the external surfaces clean and free of dirt and fluids using a clean
dry cloth.
1. Wipe any fluids from the surface of the product using a clean dry
cloth.
2. Wipe with a cloth dampened in 70% Isopropyl Alcohol.
3. Completely dry with a clean, dry lint free cloth.
4. If the product has been contaminated use the methods described for
patient applied parts.
4.3 Cleaning and Disinfecting Patient Applied Parts
Clean the probes before examining a patient using low risk cleaning method
below.
Following patient examination, clean and/or disinfect the probes by the
appropriate method based upon the level of cross contamination risk, as defined
below:
Risk Definitions Procedure
Low Normal use or low risk
situations include patients
having intact skin and no
known infection.
1. Remove soiling, wipe with a mild
neutral detergent and then wipe
with a cloth dampened in water.
2. Completely dry with a clean lint
free cloth.
Medium The patient has a known
infection, skin is not intact,
the part is heavily soiled.
1. Follow low risk procedure then
wipe with a cloth dampened in
Sodium Hypochlorite (1,000ppm).
2. After two minutes wipe with a cloth
dampened in water and then dry
with a clean lint free cloth.
High This procedure should
only be used when
the part has been
contaminated by blood.
1. Follow low risk procedure then
wipe with a cloth dampened in
Sodium Hypochlorite (10,000ppm).
2. After two minutes wipe with a cloth
dampened in water and then dry
with a clean lint free cloth.

17
Care and Cleaning
Warning: Sodium Hypochlorite @ 10,000 ppm for disinfecting
should only be used in situations described in the High Risk
definition. Unnecessary use of this concentrated solution for
Low and Medium risk situations may result in damage to the
product. Do not allow Sodium Hypochlorite solutions to come
into contact with metal parts.
The use of disinfectant materials other than those listed is the responsibility of
the user for their efficacy and compatibility with the device.
4.4 Maintenance and Repair
There are NO USER SERVICEABLE PARTS inside the control unit or probe.
Inspection is recommended each time the product is used, paying particular
attention to the tip of the probes, checking for cracks etc., and to the cable and
connector. Any crackling or intermittent behaviour should be investigated.
This product does not require periodic maintenance.
Suitable test equipment and a full range of spare parts are also available.
Please refer to service manual for further information and part numbers.
A full technical description is provided in the Service Manual 726374.

18
Specifications
5. Specifications
5.1 Equipment Classification
Type of protection
against electric shock.
Internally powered equipment
Degree of protection
against electric shock Type B - equipment with an applied part.
Mode of operation. Continuous
Degree of protection
against harmful ingress
of particles and/or water.
Main Unit: IP20
Probes (Tip only): IPX1
Degree of safety of
application in the
presence of a flammable
anaesthetic
Equipment not suitable for use in the presence of
a FLAMMABLE ANAESTHETIC MIXTURE WITH
AIR, OXYGEN OR NITROUS OXIDE
5.2 Standards Compliance
IEC60601-1: 1988 + A1:1991 +A2:1995
UL60601-1 : 2006
CSA C22.2 No 601.1-M90 (R2005)
5.3 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)

19
Specifications
5.4 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.
5.5 General
Max. Audio Output
(Loudspeaker)
500mW rms typical
Auto shut-off 3 minute no signal
10 minute unconditional
Headphones Max. output Power: 25 mW rms (32Ω)
Connector: 3.5mm stereo jack socket
Max. applied voltage: +9Vdc
RS232 Interface
(MD2 only)
Data format: RS232C
Connector: 8pin subminiature DIN socket
Max. applied voltage: +5Vdc
Battery Type IEC 6LR61 or IEC 6LP3146
Battery Life Typically, 250 x 1 minute examinations
Size Height 5.5”, Depth 1.1”, Width 2.9”
Weight 10oz including probe and battery
5.6 Environmental
Operating Storage
+50°F to +86°F
(+10°C to +30°C)
Temperature range +14°F to +104°F
(-10°C to +40°C)
10% to 90% (non
condensing)
Relative Humidity 93% maximum
860mb to 1060mb Pressure 860mb to 1060mb

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