OPERATOR’S MANUAL

CONTENTS
OVEVIEW 4
Description
Indications for Use
Contraindications
GETTING STARTED 6
System Components
Unpacking
Consideration When Joining Network Domain
Opening Display and Set-Up
A-SCAN 11
Patient Database
Exam Mode
Verify Calibration
Exam Mode
Calculation Mode
Reports
DIAGNOSTIC A-SCAN 16
PACHYMETRY 19
Select Exam Mode
Perform Exam
Report
B-SCAN AND UBM 22
Configure System
Patient Database
Exam Mode
MAINTENANCE 27
Cleaning and Disinfection
SPECIFICATIONS 31
A-Scan Specifications
UBM / B-Scan Specifications
Pachymeter Specifications
General Specifications
ALARA and Emissions
Immunity Test Levels
WARNINGS AND CAUTIONS 47
CYBER SECURITY RECOMMENDATIONS 50
WARRANTY 52
SYMBOLS 54

2
CONTACT INFORMATION

Sonomed, Inc.
1979 Marcus Avenue, C105
Lake Success, NY 11042, U.S.A.
Tel: 800-227-1285
Tel: 516-354-0900
Fax: 516-354-5902
[email protected]
www.sonomedescalon.com

Authorized Representative for Medical Devcie Directive:

Emergo Europe
Prinsessegracht 20
2514 AP The Hague
The Netherlands
Tel: +31 (0)70-345-8570
Fax: +31(0) 70-346-7299
United States Federal law and European regulations restrict this device to use
by, or on the order of, a physician. This device should only be used under the
supervision of an experienced ophthalmic medical practitioner in a clinical
setting. Before examining a patient, the user should become acquainted with
the operating procedures, warnings and precautions set forth in the Operators
Manual. The user should consult additional resources as necessary for further
information regarding the proper application of ultrasound technology. If
difficulty is experienced when operating the unit after carefully reviewing this
Operators Manual, contact your local Sonomed Escalon distributor for
assistance
This instrument should be used in strict accordance with the instructions
outlined in this Operators manual. The safety of the operator and the
performance of the instrument cannot be guaranteed if used in a manner not
specified by Sonomed Escalon.
Do not use the device together with HF surgical equipment. HF surgical
equipment may be damaged, which may result in fire.
There are no user-serviceable parts within the VuPad system.
To receive a translated copy of this manual, contact your in-country distributor,
or call Sonomed directly at 516-354-0900 or 800-227-1285. For technical
service and support please contact Sonomed Escalon or your local distributor.

Document No. 5575-1901-E, Aug 2019

3
OVERVIEW
DESCRIPTION
The VuPad™ is an ophthalmic ultrasound system capable of utilizing a range of
transducer frequencies for optimized imaging and measurements of various
ophthalmic structures. The device is a multi-purpose system intended for use
in ophthalmic applications designed to capture images of the interior of the eye
and make accurate measurements of the structures.

The VuPad™ is a stand-alone system that runs on a Windows 10 platform and

may be networked (by the user) for interface with electronic medical records
systems, printing, and other purposes. The system consists of the VuPad™
console, ultrasound probe(s) and transducer(s), and foot pedal.

The device is used by coupling the probe/transducer to the eye either through
direct contact or immersion methods. Available modes are biometric A-scan,
pachymeter, diagnostic A-scan, B-scan, UBM (ultrasound bio-microscope).

Biometric A-Scan
A-Scan is a noninvasive tool that produces length measurements along the
visual axis of the eye for calculation of intraocular lens power. This method
enables precise measurement of the anterior chamber depth (ACD), lens (L),
and vitreous to produce the axial length of the eye. When a cataract is
removed, the lens is replaced with an artificial lens implant. By measuring both
the axial length of the eye (A-scan) and the power of the cornea (keratometry),
a user selected formula can be used to calculate the power of the intraocular
lens needed.

Pachymeter
Pachymeter is a noninvasive tool that produces measurements of the thickness
of the eye’s cornea. It is used to perform corneal pachymetry prior to refractive
surgery, for keratoconus screening, limbal relaxing incisions surgery and is
useful in screening for patients suspected of developing glaucoma among other
uses.

4
Diagnostic A-Scan
Diagnostic A-Scan is a noninvasive tool that enables diagnostic evaluation of
detected eye pathologies found with B-Scan screening. This method enables
imaging of structural amplitudes for analytical determination of the patient’s
eye disorder.

B-Scan
B-Scan is a noninvasive tool that produces a cross-section, two-dimensional
grayscale images for diagnosing pathologies of the posterior segment of the
eye. This method enables imaging when the light-conducting media of the eye
are opaque. Common conditions such as cataract, vitreous degeneration,
retinal detachment, ocular trauma, choroidal melanoma, and retinoblastoma
can be accurately evaluated with this modality.

UBM/ Ultrasound Bio-Microscopy (UBM-Mode)

UBM is a noninvasive tool that produces high resolution cross-section, two-
dimensional grayscale images of the anterior segment of the eye. This method
enables imaging of structural details such as Bowman's membrane, stroma,
cornea, anterior chamber, lens, iris, ciliary body, and scleral spur. Other
parameters such as iris area and volume, angle opening distance, angle recess
area, sclera thickness, and trabecular meshwork-ciliary process can be
evaluated and measured. Common conditions such as glaucoma, iris cyst,
neoplasms, trauma and foreign bodies can be accurately identified

INDICATION FOR USE

The VuPad™ is intended to be used to visualize and measure the eye and orbit
using B-Scan and A-scan ultrasound.

CONTRAINDICATIONS
The VuPad™ is not intended for fetal use.

5
GETTING STARTED
SYSTEM COMPONENTS

PROBES
A-Probe 10 MHz

B-Probe
(12 or 20 MHz Probes)
Water Path Probe
(with 35 or 50 MHz Transducers)

Foot Pedal

Power Ethernet USB Power

On/Off Cable

6
UNPACKING
① Unpack contents from packaging.

② Connect power cord between console and wall outlet.

NOTE: Console may be propped on its stand or attached to a VESA
mount.
CAUTION: Position such that console is well ventilated with easy
access to disconnect power cords, as may be necessary.

③ Connect the probe cables to unit and place probes into probe holders.
NOTE: The same cable is used for all B-scan and UBM probes.

④ Power on console. System will boot up into a Windows 10 home screen

and the VuPad icon can be selected to launch the program.
NOTE: Console may be powered off by pushing the power button.

CONSIDERATION WHEN JOINING TO

NETWORK DOMAIN
The Vupad uses Windows 10 and may be joined to (or removed from) a
network domain. However, when doing so, it is required that the local user
account is set up as a local administrator on the ultrasound system.

One potential issue to keep in mind is that when an ultrasound system is joined
to a domain, the domain rules are typically pushed down, which can prevent a
local user account from having full permissions (this would result in the
ultrasound system not functioning properly). Please ensure that the local user
account is set up as an administrator on the ultrasound system via your domain
rules (i.e. the local user must remain as the local administrator).

For questions, please contact technical service at 516-354-0900 or

800-227-1285 or email [email protected].

7
OPENING DISPLAY AND SETUP
① OPEN THE VUPAD PROGRAM by clicking on the VuPad Icon located on the
desktop screen.

② CLICK ON THE “CONFIGURE” TAB. This will allow the user to set up defaults
for the MD/Examiner by:
* Select “New MD/Examiner” tab and complete the requested information
for MD/Examiner using the on-screen keyboard (or optional external
Bluetooth keyboard). (see Fig. 1)
* The user can also designate any user as the “Default Examiner” or
“Default Attending” (required for Biometric a-scans) by selecting the
appropriate tab(s).
* The preferred lenses (IOL’s) can be selected by selecting the “Lenses” tab
on the user setup screen. Pressing “ADD” will display a window
showing Lens Manufacturers on the left and lenses produced by that
manufacturer in the center of the display. Once a lens is selected, the
“ADD” key will become active and selecting this key will add the
desired lens to the users preferred list. (see Fig. 2)
* Once all information has been entered, pressing the “OK” will return the
user to the Lens screen. [Verify that the newly selected lens(s) appear
in the table. Pressing “Close” will now return the user to the “M/D
Examiner” screen.
* Pressing “Close” will return the user to the Patient Database screen.

NOTE: The above procedure can be used to enter any number of additional
users so that each individual user can select their preferred lenses, etc.

8
 Master Lens Database Tab Examiner Lens Selection

Fig. 1

MD/Examiner Setup Display:

Name: Enter Examiner Name
Type: Enter Examiner/Attending Phys./ Referring Phys.
Default Examiner: A “default” examiner can be entered for
every exam.

NOTE: In order to perform A-scan biometry measurements, an

“Attending” physician must be entered. Selecting a
“Default Attending” will automatically assign this user
for each exam.

9
 Fig. 2

Lens Selection Screen:

Manufacturer: Scroll and Select the Lens Manufacturer’s Name.
Lenses: Scroll and Select the desired Lens Model.

NOTE: The “Lens Database” Tab (see Fig.1) includes over 1500
lenses and associated data which the user can update, by
adding, deleting or editing lenses.
The “LENSES” Tab is the Examiner Lens Selection tab from which
the Examiner must choose the desired lenses from for
performing IOL calculations.

10
A-SCAN
PATIENT DATABASE
① PATIENT: Select the “NEW” tab located at the top left side of the database
display screen.
NOTE: For previously entered patient, scroll through patient list, by sliding
the scroll indicator just to the right of patient list until the desired patient
name is displayed.
② ENTER NEW PATIENT Information into the appropriate fields (see Fig. 3)
[Note: K-readings can be entered here or later if performing a-scan
biometry.]….. Press “OK”

Fig. 3

EXAM MODE
① EXAM: Select the “NEW” tab located at the top right side of the database
display screen.
② Verify Examiner [Required], Attending Phys [Required], and Referring
Phys (if needed) are entered.

11
③ ENTER THE EXAM TYPE [Bio A] and Laterality [OD/OS]. [If the exam is to be
used as a teaching case, place a checkmark in the box labeled “Teaching
Case”]. Press “OK”

④ ENTER PARAMETERS: K-readings can be entered for either/both eyes. If

the patient has had previous refractive surgery, pressing the “Post
Refractive” tab will allow the user to select the formula and IOL Correction
[Aramberri Double K, Latkany Myopic/Hyperopic] to apply to the lens
power calculation. Then select the “OK” tab.

VERIFY CALIBRATION
① The Verify Calibration Window should be displayed if the “Bio A” tab had
been selected previously.
- Select YES to perform the calibration verification. The VuPad will
start emitting an audio “beeping”. Place a drop of water onto the face of
the a-scan probe and press the probe onto the calibration cylinder (located
on left side probe holder). Once the correct pattern is accepted by the
instrument, the beeping will stop and the message “Calibration Verified”
will appear.
[Note: It may be necessary to increase the “Gain” control in order to
achieve the desired pattern].
-Select NO to bypass the calibration verification procedure.

EXAM MODE
① Select the desired OD/OS tab located on the top of the display. Then
proceed as follows: (see Fig. 4)
*SCAN Tab: Select the desired mode (Cataract, Aphakic, etc.) for the eye to be
examined. The user can also select “immersion” mode if using an
Immersion Shell for biometry.
* BIOMETRY Tab: will display the collected data as the scans are performed
and accepted.
* SETTINGS tab: will display the various velocities used for the selected mode.
The user can adjust these values if needed by using the ▲ /▼ symbols.

12
 A-scan Calculations Reports

Fig. 4
- The “CONTINUOUS CAPTURE” tab, if selected, will allow the user to set
the desired number of scans that the VuPad will obtain with a single press
of the footswitch. If “Immersion” mode has been selected, TWO footswitch
presses would be required to begin obtaining scans – once to activate the
transducer for alignment and one to activate the algorithm for scan
acceptance.
* HISTORY tab: records all previous a-scan exams [Date/Time/ Exam type] for
the selected patient.

② For “Direct Contact” scanning, press the “START SCAN” tab at the bottom
of the display (or press the footswitch). The VuPad will emit a continuous
beeping sound indicating that the scan mode has been activated. Place the
probe in contact with the cornea and instruct the patient to look at the
RED FIXATION light at the tip of the probe. Once the proper alignment is
achieved, the VuPad will begin to accept scans which will be shown on the
right side of the display screen. Once the desired number of scans are
accepted, the VuPad will cease emitting the beeping sound.
For “Immersion” scanning, the user should press the “ALIGN PROBE” tab
(or footswitch) until alignment is achieved. Once the user is satisfied that
the probe is properly aligned, pressing the “START SCAN” tab (or
footswitch a second time) will activate the scanning algorithm and begin to
collect scan data.

13
③ Selecting the BIOMETRY tab, will permit the user to view all the data
collected from the scan session including the ACD, LENS THICKNESS,
VITREOUS DEPTH AND AXIAL LENGTH for all scans in the set.
- The user can omit a scan from being included in the Average by un-
checking the “Enabled” box located to the left of each data set. This
does not delete the scan from the record.
- The user can “Delete” a scan from the record by selecting and holding
the individual scan data (for approximately 2 seconds) located on the
right side of the display and selecting “delete” from the pop-up menu.
This will delete the scan and all associated data from the record.

CALCULATION MODE
Once the user has reviewed and is satisfied with the scan results, the
CALCULATIONS tab, located at the top of the measurement display screen,
should be selected. (See Fig. 4)

① Enter the “Target” refraction and K-readings (if not entered previously)
② Average AXL and ACD should populate based on previous screen.
③ LINK tab will enable to user to display the same Formula or the same Lens
for all 4 of the calculation tables.
④ LENS can be selected from the drop-down menu which will include all lens
models previously added to user profile.
⑤ Formulas can be selected from the drop down menu which will include all
formulas previously added to profile.
⑥ IOL table will display with the “Target” refraction entered previously at the
center. The user can edit the center value by changing the value in the
“Target” refraction field. (step 1 above).
⑦ Once all values are approved and accepted, the user should select the
“ADD TO REPORT” tab located on the bottom right of the display.
⑧ If the fellow eye is also to be measured and included onto the report the
user should select either the OD or OS tab at the top of the display and
repeat the measurement/calculation steps described above.
⑨ Once the eye(s) is measured, calculations performed and “ADDED TO
REPORT” the REPORT tab located at the top of the display should be
selected.

14
REPORTS
Once the REPORT tab is selected, the display will show the report template (see
Fig. 5) which includes the A-scan(s) and IOL calculations for each eye for which
the measurement/calculations were performed. If required, the user can return
to the calculation tables, edit the lens and/or formula data and select the ADD
TO REPORT tab again. This will generate a second page to the report which will
now display 2 of 2, 3 of 3, etc…..

INCLUDE HEADER: If this tab is highlighted, the default header

[SonomedEscalon] will be displayed. Deselecting this tab will cause the
Header to be removed from the report.
REMOVE PAGE: Highlighting this tab will remove the currently displayed page
from the report.
PRINT: Selecting this tab will display the Windows print window to appear from
which the user can select any of the installed printers.
EXPORT: Selecting this tab will display the Export pop-up window to appear for
selection of export format by the user.

Press “CLOSE EXAM” when finished to return to the patient database screen.

Fig. 5

15
DIAGNOSTIC A-SCAN MODE
① Power ‘On’ System: By pressing the front panel power switch located on
the bottom right side of the unit’s front panel.

② Starting Application: From Windows desktop, double click on the

‘VuMaxHD Software’ icon (Fig. 6).

Fig. 6 - VuMAX HD Software Icon

③ Patient Database Screen: Upon launching the application the ‘Patient

Database’ screen (Fig. 7) will display. Here you can add a new patient or find
previously performed exams.

Fig. 7- Patient Database Screen

④ Diagnostic A-Utility: To start the Diagnostic A-Scan application, select the

‘Diagnostic A-Utility’ button (Fig. 8).

Fig. 8 - ‘Diagnostic-A Utility’ Button

16
⑤ Application Window: Upon selecting the ‘Diagnostic-A Utility’ button the
VuMAX HD patient database will momentarily close and the Diagnostic A-Scan
Utility screen will open (Fig. 9).

Fig. 9 - Diagnostic-A Utility Screen

⑥ Begin Scan, Stop Scan and Save: To commence a live scan, select the
‘Begin Scan’ button. Upon selection an A-Scan trace will appear on the main
window. To stop scan, click on the correspondent icon as well as for save a
screenshot (Fig. 10)

Fig. 10- ‘Begin Scan’ ‘Stop Scan’ and ‘Save” Buttons

⑦ Save As: Upon selecting the ‘Save Screenshot’ button, a Windows ‘Save
As’ screen (Fig. 11) will be displayed. Navigate through the folders to select a
destination folder for saving the patient’s saved A-Scan. Note that a ‘File
Name’ is required for saving the document.

17
 Fig. 11 ‘Save As’ Window

⑧ Close and Return: Upon completing examination and saving a record of

the test, select the ‘Close and Return’ button to return to the VuMax HD
Patient Database screen.

⑨ Calibration: Clicking on the Sonomed Escalon logo while having the

control key pressed, it will pop up the S curve calibration as in Fig.12.

Fig. 12 Calibration Screen Window

18
PACHYMETRY
SELECT EXAM MODE
① EXAM: Select the “NEW” tab located at the top right side of the database
display screen.

② Verify Examiner [Required], Attending Phys [Required], and Referring

Phys (if needed) are entered.

③ ENTER THE EXAM TYPE [Pach] and Laterality [OD/OS]. [If the exam is to be
used as a teaching case, place a checkmark in the box labeled “Teaching
Case”]. Press “OK”

PERFORM EXAM

Fig. 13

19
① Select desired exam mode option: (Fig 13 and 14)
- Single Point | Single Reading Provides for a single reading at a single
point on cornea.
- Single Point | Multiple Readings Proides for up to 5 readings at a
single point on cornea.
- Multiple Points | Single Reading Provides for a single reading at up to
9 points on cornea.
- Multiple Points | Multiple Readings Proides for up to 5 readings at up
to 9 points on cornea.
Note: If multiple points are to be scanned, select appropriate location on
corneal map to first measure.

② Confirm Tissue Velocity is appropriate; tap to change as desired.

③ Enter measured IOP if corrected IOP based on corneal thickness is desired.

④ Select whether a single or multiple points should be automatically taken

once system scan criteria are met.

⑤ Select “SCAN” button to start scan (or press foot pedal).

⑥ Repeat, as necessary, to measure all desired points. Readings can be

cleared and repeated, if necessary.

Fig 14

20
REPORT
① Select “Report” button to generate pachymetry report (Fig. 15).

Fig 15

21
B-SCAN AND UBM
CONFIGURE SYSTEM
① After logging in by entering the administrator name and password, the
home screen is the patient database, which shows a history of patients and
their respective exams. From this screen, select the <Configure> button.

② ENTER ASSOCIATE INFORMATION by selecting the <New> button, entering

information and clicking the <Apply> button. Each associate can be
designated as an examiner, attending physician, and/or referring physician.

③ ENTER ULTRASOUND INFORMATION by selecting the Ultrasound tab and

selecting the <Add…> button. Enter the frequency in MHz of any water
path transducer(s).

④ ENTER DIAGNOSES FOR REFERENCE ON EXAM RECORDS by selecting the

Diagnoses tab and selecting the <New Diagnosis> tab.

PATIENT DATABASE
Upon opening the VuPad program, the home screen shown is the patient
database, which shows a history of patients and their respective exams. From
this screen, several functions can be performed:

① SEARCH for patients by entering the known information and selecting the
<search> button. A list of patients matching the criteria will be shown.
Select the <clear> button to return to a list of all patients.

② ENTER NEW PATIENT by selecting the <new patient> button, entering

appropriate information, and selecting the <Apply> button.

③ DELETE PATIENT by selecting the <Delete> button in the patient section.

NOTE: Deleting a patient record will also delete all associated exam
records. A prompt will appear to confirm intent to actually delete a
patient record.

22
④ SELECT PATIENT by highlighting the patient from the patient list – a history
of any saved exams for the patient will appear in the exam list.

⑤ SELECT EXISTING EXAM by double-clicking on an exam record for a

particular patient. This function opens the exam and displays associated
images (see EXAM RECORD section of this user manual).

⑥ CREATE NEW EXAM by selecting the <New Exam> button.

NOTE: Patient information must be entered first.

⑦ DELETE EXAM RECORD by selecting the <Delete> button in the exam

section.
NOTE: Deleting an exam record will delete all associated images and
data. A prompt will appear to confirm intent to actually delete an
exam record.

⑧ IMPORT EXAM RECORDS by selecting the <Import> button and following

the on-screen instructions.

⑨ EXPORT EXAM RECORDS by selecting the <Export> button and following

the on-screen instructions.
NOTE: This function may be useful when connecting to an EMR
system, referrals, or creating presentations.

⑩ PRINT REPORT by selecting the <Report> button. In the Report screen, the
images may be selected (across the patient’s history of exams) and the
format chosen for one, two, four, or six images per page.
NOTE: The report header may be toggled on or off by selecting the
<Header> button.

⑪ CONFIGURE SYSTEM by selecting the <Configure> button to enter

examiner, physician, and referring physician information, among other set-
up tasks.

23
EXAM MODE
After selecting the <New Exam> button from the Patient Database screen,
enter the exam information, the Exam screen is shown from which imaging can
be performed.

① SELECT THE PROBE FREQUENCY to be used from the drop-down menu and
select the <Refresh Probes> button.
Standard B-Scan Mode: 12 MHz or 20 MHz probes may be used.
UBM Mode: 35 MHz or 50 MHz transducer may be used in conjunction
with a water path probe.

② SELECT APPROPRIATE PRESET SCAN MODE and/or adjust image controls

for optimizing image quality for the particular structure of interest.
Available image controls and preset scan modes are shown on the next
page.
NOTE: Image controls may also be adjusted during or after a scan.

③ PLACE PROBE INTO POSITION AND START SCANNING by either depressing

the footswitch or selecting the <New Scan> button. When the footswitch is
pressed or <Stop Scan> button selected, a video clip of the prior 50 frames
is captured.
DANGER! WHEN USING THE WATER PATH PROBE IN UBM MODE (35
OR 50 MHZ), THE USER MUST TAKE EVERY PRECAUTION TO PREVENT
THE TRANSDUCER FROM TOUCHING THE EYE. CONTACT BETWEEN A
MOVING TRANSDUCER AND THE EYE CAN CAUSE SEVERE INJURY.

④ REVIEW SCAN by selecting the Play button and selecting the playback rate
(or scroll through video clip one frame at a time). Image controls may be
adjusted to see the effect on the displayed image, including use of the
zoom feature. Individual frames may be saved by selecting the <Save
Frame> button.

⑤ ANNOTATE SCAN by selecting Tools tab and selecting the desired function.
Annotations are saved with the associated video clip or image.
NOTE: A frame is automatically saved when an image is annotated.

24
ANNOTATIONS

Angle Measurement places adjustable angle edges onto image

and displays angle in degrees.

Arbitrary A-Scan allows user to see an A-scan trace along any

vector.

Linear Measurement places adjustable calipers onto image and

displays distance.

Pan allows user to move image while holding down the left
mouse button.

A-Scan displays an A-scan trace along the axis of a B-scan image.

(B-scan only)

Measurement Template displays approximate common

measurements for UBM sulcus-to-sulcus video clips with ability to
move measurement endpoints. (UBM-only)
Refresh Measurements will reset measurements to those auto-
generated by system. (UBM-only)

Clear removes the highlighted annotation from the image.

Diagnosis Add or Remove a diagnosis by selecting the appropriate buttons.

Notes Add or Remove notes by selecting the appropriate buttons.

⑥ EXPORT FRAME by selecting Tools tab and selecting <Export JPG> button.

⑦ USE NOMOGRAMS TO DETERMINE ICL LENS SIZING by selecting the Tools

tab and selecting the desired nomogram and entering required
information to yield the resultant lens size.
⑧ EXIT EXAM MODE by selecting <Finish Exam> button.

25
IMAGE CONTROLS

Time Variable Gain (TVG) attenuates near field portion of

TVG
scan sector.
Baseline Affects low-level signal threshold to help reduce noise.

Zoom Adjusts area of scan sector display on monitor.

Log Gain Adjusts overall amplification of received signal.

Adjusts overall signal amplitude in image with minimal effect
Exp Gain
on low-level noise (otherwise known as “E-Gain”).

UBM PRESET MODES

Optimized to measure sulcus-to-sulcus for lens sizing with wide

30° scan angle. Note: When measuring sulcus-to-sulcus, ensure
Sulcus-
iris plane is saturated, with anterior and posterior lens echoes
to-Sulcus
visible. It is advisable to perform multiple scans with
measurements to ensure most accurate results.
With scan angle of 15° and mid-range settings for gain and scan
Angle
frequency, optimized to provide excellent detail of angle
Detail
structures, tumors, traumas, and fine details.

B-SCAN PRESET MODES

Orbit Optimized to image the orbit with 50° scan angle.

Deep
Optimized to view beyond the surface of the retina and into the
Retina /
choroid, with a 50° scan angle.
Choroid

26
MAINTENANCE
SYSTEM CLEANING
Clean the VuPad™ probes with a damp cloth to remove gel and other debris.
Use appropriate products to clean the cabling and foot pedals as necessary.
WARNING: Disconnect the AC POWER before cleaning the system.

PROBE CLEANING AND DISINFECTION

The probe must be cleaned and disinfected between patients to prevent
patient-to-patinet transmission of infection. Prior to any cleaning or
disinfecting, unplug the probe from its cable. Cleaning is intended to remove
dirt and debris form the probe, and to reduce the presence of microorganisms.
Disinfection is performed after cleaning.

A-SCAN / B-SCAN / PACHYMETRY PROBES

① Cleaning of Probes:
a) A few drops of common concentrated dishwashing detergent diluted
in a liter of warm tap water may be used. Scrub the probe in a soapy
solution that facilitates the suspension and washing away of the
unwanted contaminants. The probes may be vigorously scrubbed, as
needed, to remove contaminants. A soft bristle brush may be used to
scrub the narrow gap where the probe window joins the probe cover.
b) Rinse the probe thoroughly with water and allow to air dry or blot dry
with a soft, lint-free cloth or gauze.

② Disinfection of Probes:
a) For low-to-moderate disinfection: After cleaning, immerse the probe
in 70% isopropyl alcohol (70% IPA) for 5-10 minutes. Rinse the probe
thoroughly with distilled or deionized water and allow to air dry or
wipe dry with a soft, lint-free cloth or gauze. If not used immediately,
the probe may be placed in a clean bag for storage.
b) For a higher level of disinfection: After cleaning, immerse the probe in
2-3% W/W hydrogen peroxide for 8-10 minutes. Rinse the probe
thoroughly with distilled or deionized water and allow to air dry or
blot with a soft, lint-free cloth or gauze. If not used immediately, the
probe may be placed in a clean bag for storage.

27
 c) The probe is hermetically sealed and, if necessary, the entire probe
(up to the connector) may be immersed in either disinfecting solution
(70% IPA or hydrogen peroxide). However, this should be reserved for
rare cases where it is judged by the clinician that the entire probe has
been contaminated. When this is not the case, then it is only
necessary to immerse the portion of the probe that has been in
contact with the patient, plus approximately 2 cm. of the probe cover.
** CAUTION: NEVER IMMERSE THE CONNECTOR AT THE END OF THE
PROBE! **

WATER PATH PROBES

① Cleaning of Water-Path Probes:
a) Remove the “cap” that protects the rubber boot.
b) A few drops of common concentrated dishwashing detergent diluted
in a liter of warm tap water may be used. Lightly scrub the probe in a
soapy solution that facilitates the suspension and washing away of the
unwanted contaminants. The probes may be vigorously scrubbed, as
needed, to remove contaminants.
c) The hard, plastic parts of the probe, including the protective cap, may
be vigorously scrubbed, as needed to remove contaminants. A soft
bristle brush may be used to scrub crevices. Take care to thoroughly,
but only lightly, scrub the soft rubber boot.
d) The gold surface of the transducer may be washed with very light
pressure. Take care NOT to scrub the face of the transducer harshly or
to use any abrasive cleaners or cloths. Careful cleaning will lengthen
the useful life of the transducer.
e) Rinse the probe thoroughly with distilled or deionized water and allow
to air dry or very lightly blot dry with a soft, lint-free cloth or gauze.

② Disinfection of Water-Path Probes:

a) For low-to-moderate disinfection: After cleaning, immerse the probe
in 70% isopropyl alcohol (70% IPA) for 5-10 minutes. Rinse the probe
thoroughly with distilled or deionized water and allow to air dry or
wipe dry with a soft, lint-free cloth or gauze. If not used immediately,
the probe may be placed in a clean bag for storage.
b) For a higher level of disinfection: After cleaning, immerse the probe in
2-3% W/W hydrogen peroxide for 8-10 minutes. Rinse the probe
thoroughly with distilled or deionized water and allow to air dry or

28
 blot with a soft, lint-free cloth or gauze. If not used immediately, the
probe may be placed in a clean bag for storage.
c) The probe is hermetically sealed and, if necessary, the entire probe
(up to the connector) may be immersed in either disinfecting solution
(70% IPA or hydrogen peroxide). However, this should be reserved for
rare cases where it is judged by the clinician that the entire probe has
been contaminated. When this is not the case, then it is only
necessary to immerse the portion of the probe that has been in
contact with the patient, plus approximately 2 cm. of the probe cover.
** CAUTION: NEVER IMMERSE THE CONNECTOR AT THE END OF THE
PROBE! **
d) If necessary, the transducer may be detached from the probe and the
two disinfected separately in either 70% IPA or hydrogen peroxide. If
detached for cleaning, take care that the surface mount connector
(SMC) of the probe and transducer are thoroughly dried before
remounting the transducer to the probe. The internal surfaces of the
transducer connections must be free of moisture prior to re-assembly.
Special care should be taken not to rub the gold surface of the
transducer.

WARNINGS WHEN CLEANING WATER-PATH PROBES

a) Sodium Hypochlorite (i.e. Bleach): Diluted (0.6% concentrations) and

undiluted bleach solutions attack the gold plated surfaces of the
probe, and once a breach has been made, the sensitivity of the
transducer is diminished (proportional to the loss of gold plating).
Therefore, cleaning and disinfection methods employing 0.6%
concentrations, or more, of sodium hypochlorite should be avoided
whenever possible.

b) Tap water: Contaminants in common tap water have been found to

attack and corrode the metal surfaces of the probe and transducer
after extended use. The use of tap water, rather than sterile deionized
water or distilled water is, therefore, contraindicated. After a probe is
cleaned, soaked, or rinsed with tap water, rinse with distilled or
deionized water and lightly wipe the surface clean of any residues.

c) Abrasives: The gold plating on the transducer surface is very thin and
cannot be thickened without negatively affecting the transducer
frequency and performance. Therefore, extreme care must be taken

29
 to avoid scratching or otherwise damaging the gold surface of the film.
Never use any kind of abrasive cloth or tissue when wiping the
transducer surface. Camera lens cleaning paper or soft gauze may be
used. Apply no more force than is needed when wiping the transducer
surface. Minor scratches to the gold surface will not damage
performance. Contact the manufacturer if the gold plating is breached
and a silver color is seen in place of the gold.

CAUTION:
Do not autoclave any probes; excessive temperatures will cause damage

DISPOSAL
When disposal is required, the equipment and associated cleaning and
disinfecting chemicals should be disposed of in accordance with local, state,
and federal laws.

TECHNICAL SERVICE AND SUPPORT

There are no user-serviceable parts within the system. Please contact Sonomed
Escalon or your local distributor to request technical service and support.
Technical support 800-227-1285 or 516-354-0900.

Email: [email protected]

30
SPECIFICATIONS
A-SCAN SPECIFICATIONS
Ultrasound Sealed 10 MHz focused transducer with standard probe
Probes (max length 5 ft cord)
Scan Modes Direct contact or immersion
Manual or automatic capture (cataract, dense cataract, aphakic,
and pseudophakic)
Measurements Anterior depth (ACD), lens thickness, vitreous, and axial length
(AXl)
Averages and standard deviation calculated for up to 10 scans per
exam
Configurable zone tissue velocities
IOL Formulas Standard: Binkhorst, Regression-II, Theoretic/T, Holladay, Hoffer-
Q, Haigis (optional); Post-Refractive: Latkany Myopic Regression,
Latkany Kyperopic, Aramberri Double-K
Axial Resolution 0.0193 mm
Accuracy ±0.1 mm

UBM / B-SCAN SPECIFICATIONS

Ultrasound B-Scan: HD series of sealed B-scan probes with focused
Probes transducers available in 12 MHz or 20 MHz frequencies
(max length 6 ft cord)
UBM: HD water path probe (max length 6 ft cord) with
interchangeable focused transducers available in 35 MHz or 50
MHz frequencies and scan cap kit with four (4) different sizes
Image Enhanced Focus Rendering™ (EFR™) with continuous interpolative
Rendering zoom re-renders at each magnification level for optimized image
quality (up to 8x zoom)
Scan Position B-Scan One-click selection of transverse or longitudinal scan clock
Indicators position with eye model confirmation (P/PE/EP/E/EA/O/CB/AX
standardized labeling based on Acoustic Section Labeling Diagram
from "Ultrasound of the Eye and Orbit", 2nd Edition, by Sandra
Frazier Byrne and Ronald L. Green, MD)
UBM: One-click selection of axial or longitudinal scan clock
position with eye model confirmation
User may add further free-form text for scan position details which
are automatically annotated onto images and video clips
Scan Controls A-Scan: Gain and sensitivity
B-Scan / UBM: Fully adjustable time-varied gain (TVG), baseline,
log gain, and exponential gain (e-gain)

31
UBM / B-SCAN SPECIFICATIONS (cont’d)

Preset Scan UBM: Selectable preset scan setting profiles to optimize image
Settings quality for each frequency probe: high resolution, sulcus-to-sulcus,
angle detail, and motion picture
2D Scan 256 ray scan with 2048 sample points for each ray (524,288
Sampling sample points per sweep)
2D Video Clips Capture and store 50-frame video clips at rates up to 20 frames
per second (fps), depending upon scan setting. Store up to 12
video clips per exam and replay in real-time, scalable slow motion,
or one frame at a time.
Images Separately save any number of individual frames from video clips
as images, complete with annotation(s)
A-Scan Trace Superimpose A-scan trace onto images with a single button click
with either arbitrary A-scan with caliper scan length adjustments
or vector A-scan with adjustable vector
Annotation Automatic annotation of images and video clips with patient and
user identification, exam date, scan indicator position, transducer
frequency, and scan settings; Unlimited measurements using
linear calipers and angle measurement tool

PACHYMETER SPECIFICATIONS
Ultrasound Sealed 20 MHz focused transducer with standard probe
Probes (max length 5 ft cord)
Scan Modes Direct contact
Measurements Single Reading – Single Point
Mulitple Reading – Single Point
Single Reading – Multiple Points
Multiple Reading – Multiple Points
Statistical Average of 128 individual measures for each reading
Analysis Standard deviation for each reading
Average of up to 5 readings for each point
Standard deviation of up to 5 readings for each point
Measurement ± 1 micron
Precision
Measurement 5 microns
Accuracy
Customizable Corneal Velocity: 1620 – 1650 m/s
Parameters Measurement Bias: 80 -120 %
Intra-Ocular Pressure Correction (IOP) formula
Amplifier Low Noise
Automatic Gain Control
Maximum Gain = 46 dB

32
GENERAL SPECIFICATIONS
Patient Exam Searchable patient database with exam record storage and
Records expanded field set
User Profiles Add unlimited number of users with user-selectable defaults and
denotation of attending physician, referring physicians, and/or
examiner
Reports Detailed exam reports for printing or exporting
Export Feature Export images (.jpg), video clips (.avi), and exam reports (.pdf)

Display 10.1" high-resolution monitor (1920 x 1080 pixel) with High-

Definition Multimedia Interface (HDMI) and adjustable swivel and
tilt
Connectivity 802.11n dual-band WiFi, Bluetooth 4.0, GigE Ethernet LAN, USB 3.0
ports
Hard Drive 500 GB SSD solid-state hard drive (1TB optional)
Printer Any Windows-compatible printer
Operating Microsoft Windows 10
System
Power 100-120 / 200-240 V
4/2A
60 / 50 Hz
Auto-switching medical-grade power supply (250 W power
consumption, typical)
(max length 6 ft cord)
Operating Operating Temperature: 41 to 104°F (5 to 40°C)
Conditions Storage Temperature: -40 to 158°F (-40 to 70°C)
Operating Relative Humidity: 0 to 90% non-condensing
Storage Relative Humidity: 0 to 90% non-condensing
Atmospheric Pressure: 70 to 101kPa
Controls Foot pedal (max length 6 ft cord)
Dimension 13.3” x 8” x 2”

WIRELESSS SPECIFICATIONS Frequency band of operation: 5 GHz

Operating 5150 – 5350 MHz
Frequency
Bandwidth 802.11 a/n/ac: 20/40/80/MHz

RF Output 23 dBm max. (5150 – 5725 MHz) IEEE 802.11 a/n/ac

Power

33
ALARA SECTION AND EMISSIONS
(“As Low As Reasonably Achievable”)

STATISTICAL ANALYSIS OF MEASURED DATA

A statistical analysis was performed on the data to examine the upper output
limits based on a one-sided tolerance limit approach. The mean and standard
deviation of the Spatial-Peak, Time-Average Intensity and Mechanical Index
were found, and the upper output limits were calculated from the following
formula:

X = x +K*Sx

Where X is the upper output parameter limit, x is the average of the measured
output parameter, and Sx is the standard deviation of the measured output
parameter. A value of K was chosen which corresponds to a 90% probability
that 90% of all probes would fall below the calculated limits of X.

RESULTS
Statistical analysis showed that the probes tested produced MI and Ispta.3
values below FDA limit values.

ACCURACY
The accuracy of the emissions figures is approximately 26.6% for all intensity
values reported, 13.3% for all pressure values reported and 13.3% for the
Mechanical Index.

CAUTION
Care should be taken by user to minimize exposure of patient to ultrasound
energy by keeping examinations as short as possible.

34
Probe 35 MHz Transducer 50 MHz Transducer
Mode B-Mode (UBM) B-Mode (UBM)
Material Gold-plated polymer Gold-plated polymer
membrane membrane
Nominal Center 35 MHz 50 MHz
Frequency
Pule Repetition 2560 Hz 2560 Hz
Frequency
Type B-Scan B-Scan
(energy emitted during active (energy emitted during active
scan) scan)
Measure MI ISPTA.3 MI ISPTA.3
[no units] [mW/cm2] [no units] [mW/cm2]
Sample Size 3.0 3.0 3.0 3.0

K 4.258 4.258 4.258 4.258

Mean 0.086 0.025 0.023 0.002

Standard 0.0070 0.0030 0.0040 0.0004

Deviation
Limit 0.115 0.037 0.038 0.003

Probe 12 MHz Transducer 20 MHz Transducer

Mode B-Mode B-Mode
Material TPX Polymer TPX Polymer
Nominal Center 12 MHz 20 MHz
Frequency
Pule Repetition 2560 Hz 2560 Hz
Frequency
Type B-Scan B-Scan
(energy emitted during active (energy emitted during active
scan) scan)
Measure MI ISPTA.3 MI ISPTA.3
[no units] [mW/cm2] [no units] [mW/cm2]
Sample Size 3.0 3.0 3.0 3.0

K 4.258 4.258 4.258 4.258

Mean 0.149 0.105 0.135 0.240

Standard 0.0154 0.0260 0.0117 0.0504

Deviation
Limit 0.215 0.216 0.184 0.455

35
Probe 10 MHz (A-Scan) Transducer
Mode A-Mode
Material Lead Metaniobate
Nominal Center Frequency 10 MHz
Pule Repetition Frequency 5880 Hz
Type A-Scan
(energy emitted during active scan)
Measure MI ISPTA.3
[no units] [mW/cm2]
Sample Size 3.0 3.0

K 4.258 4.258

Mean 0.186 7.82

Standard .00458 0.570

Deviation
Limit 0.206 10.3

Probe 20 MHz (Pachymeter) Transducer

Mode A-Mode
Material Ceramic
Nominal Center Frequency 20 MHz
Pule Repetition Frequency 5880 Hz
Type A-Scan
(energy emitted during active scan)
Measure MI ISPTA.3
[no units] [mW/cm2]
Sample Size 3.0 3.0

K 4.258 4.258

Mean 0.0683 4.02

Standard 0.00681 0.809

Deviation
Limit 0.0973 7.47

NOTE: The energy will always be attenuated by the tissue between the transducer and the focus
when used as recommended. The values presented here are the values at the focal point, the point
of maximum intensity.

36
ACOUSTIC OUTPUT REPORTING TABLES FOR TRACK 1: AUTO SCANNING MODE
Note: Track 1 Reporting Tables show the worst-case indices for each probe type and operating
conditions that must be reported.

Sonomed Escalon 10 MHz Probe

Transducer Model
(s/n D09A655)
Operating Mode A-Mode
Application Ophthalmic
MI ISPTA.3 ISPPA.3
Acoustic Output
[no units] [mW/cm2] [W/cm2]
Global Maximum Value 0.190 8.42 8.52
Associated Pr.3 [Mpa] 0.531
Acoustic W0 [mW] 0.538 0.538
Parameters fc [MHz] 7.80 7.80 7.80
Zsp [cm] 1.90 1.90 1.90
Beam x-6 [cm] 0.177 0.177
Dimensions y-6 [cm] 0.162 0.162
PD [µS] 0.168 0.168
PRF [Hz] 5880 5880
Az [cm] 0.47
EDS
Ele. [cm] 0.47

Sonomed Escalon 12 MHz Probe

Transducer Model
(s/n 22064)
Operating Mode B-Mode
Application Ophthalmic
MI ISPTA.3 ISPPA.3
Acoustic Output
[no units] [mW/cm2] [W/cm2]
Global Maximum Value 0.167 0.135 12.9
Associated Pr.3 [Mpa]
Acoustic W0 [mW] 0.0832 0.0832
Parameters fc [MHz] 12.2 12.2 12.2
Zsp [cm] 1.60 1.60
Beam x-6 [cm] 0.0689
Dimensions y-6 [cm] 0.0824
PD [µS] 0.131 0.131
PRF [Hz] 2560 2560
Az [cm] 0.600
EDS
Ele. [cm] 0.600
Operating Control Conditions Scan angle 60°
256 lines per frame
Scan rate 10 Hz

37
 Sonomed Escalon 20 MHz Probe
Transducer Model
(s/n 22160)
Operating Mode B-Mode
Application Ophthalmic
MI ISPTA.3 ISPPA.3
Acoustic Output
[no units] [mW/cm2] [W/cm2]
Global Maximum Value 0.122 0.184 11.5
Associated Pr.3 [Mpa] 0.456
Acoustic W0 [mW] 0.0296 0.003
Parameters fc [MHz] 14.0 14.0 14.0
Zsp [cm] 1.70 1.70
Beam x-6 [cm] 0.0601
Dimensions y-6 [cm] 0.0605
PD [µS] 0.0650 0.0650
PRF [Hz] 2560 2560
Az [cm] 0.7
EDS
Ele. [cm] 0.7
Operating Control Conditions Scan angle 60°
256 lines per frame
Scan rate 10 Hz

Sonomed Escalon 35 MHz Transducer

Transducer Model
(s/n 35-00219)
Operating Mode B-Mode
Application Ophthalmic
MI ISPTA.3 ISPPA.3
Acoustic Output
[no units] [mW/cm2] [W/cm2]
Global Maximum Value 0.094 0.028 4.780
Associated Pr.3 [Mpa] 0.460
Acoustic W0 [mW] 0.003 0.003
Parameters fc [MHz] 24.095 24.095 24.095
Zsp [cm] 1.000 1.000
Beam x-6 [cm] 0.039
Dimensions y-6 [cm] 0.038
PD [µS] 0.043 0.043
PRF [Hz] 2560 2560
Az [cm] 0.7
EDS
Ele. [cm] 0.7
Operating Control Conditions Scan angle 15°
256 lines per frame
Scan rate 10 MHz

38
 Sonomed Escalon 50 MHz Transducer
Transducer Model
(s/n 50-00376)
Operating Mode B-Mode
Application Ophthalmic
MI ISPTA.3 ISPPA.3
Acoustic Output
[no units] [mW/cm2] [W/cm2]
Global Maximum Value 0.019 0.001 0.190
Associated Pr.3 [Mpa] 0.112
Acoustic W0 [mW] 0.0003 0.0003
Parameters fc [MHz] 34.168 34.168 34.168
Zsp [cm] 1.000 1.000
Beam x-6 [cm] 0.035
Dimensions y-6 [cm] 0.041
PD [µS] 0.056 0.056
PRF [Hz] 2560 2560
Az [cm] 0.7
EDS
Ele. [cm] 0.7
Operating Control Conditions Scan angle 15°
256 lines per frame
Scan rate 10 MHz

Sonomed Escalon 20 MHz Pachymeter

Transducer Model Probe
(s/n PD20.0-0108-0341)
Operating Mode A-Mode
Application Ophthalmic
MI ISPTA.3 ISPPA.3
Acoustic Output
[no units] [mW/cm2] [W/cm2]
Global Maximum Value 0.0760 4.91 3.69
Associated Pr.3 [Mpa] 0.323
Acoustic W0 [mW] 0.236 0.236
Parameters fc [MHz] 17.9 17.9 17.9
Zsp [cm] 1.00 1.00 1.00
Beam x-6 [cm] 0.153 0.153
Dimensions y-6 [cm] 0.142 0.142
PD [µS] 0.0780 0.0780
PRF [Hz] 1.70E+4 1.70E+4
Az [cm] 0.2
EDS
Ele. [cm] 0.2

39
IMMUNITY TEST LEVELS
Electrostatic Discharge
Air Discharge Voltage: 2.0 kV, 4.0 kV, 8.0 kV, 15.0 kV
Contact Discharge Voltage: 2.0 kV, 4.0 kV, 8.0 kV
Radiated Immunity, 8 0 MHz to 2.7 GHz and Proximity Fields

Radiated Immunity, Test Parameters

Frequency Range 80 to 1000 MHz 1.0 to 2.7 GHz
Field Strength 10 V/m 10 V/m
Window Tested NA 1
Modulation 1 kHz, 80%, AM
Dwell Time 0.5 seconds
Polarization of Applied Field Horizontal and Vertical

Radiated Immunity, Proximity Field Parameter

Frequency (Hz) Modulation Level V/m Test Distance
385 Pulse, 18 Hz, 50% DC 27 1.0 m
450 FM, 1 kHz Sine, ± 5 Hz Deviation 28 1.0 m
710, 745, 780 Pulse, 217 Hz, 50% DC 9 1.0 m
810, 870, 930 Pulse, 18 Hz, 50% DC 28 1.0 m
1720, 1845, 1970 Pulse, 217 Hz, 50% DC 28 1.0 m
2450 Pulse, 217 Hz, 50% DC 28 1.0 m
5240, 5500, 5785 Pulse, 217 Hz, 50% DC 9 1.0 m

Electrical Fast Transient / Burst

Transient Voltage: 0.5 kV, 1.0 kV, 2.0 kV
Transient Polarity: Positive and Negative
Repetition Rate: 100 kHz
Rise Time of Pulse: 5 nS ± 30%
Pulse Duration: 50 nS ± 30%
Burst Period: 300 ms ± 20%
Burst Duration: 15 ms ± 20%
Surge, Power Ports
Voltage: 0.5 kV, 1.0 kV Differential Mode
0.5 kV, 1.0 kV Line to Line Mode
0.5 kV, 1.0 kV, 2.0 kV Common Mode
Polarity: Positive and Negative
Pulse Phase: 0°, 90°, 180°, 270°
Open Circuit: Rise Time 1.2 µsec, Duration 50.0 µsec, Rep Rate 1 ppm
Short Circuit: Rise Time 8.0 µsec, Duration 20.0 µsec
Conducted Immunity Including ISM and Amateur Radio Bands
AC Mains and I/O Cables
Frequency Range, Test Level: 0.15 to 80 MHz, 10 Vms
ISM Test Frequencies: 6.765 to 6.795, 13.553 to 13.567
26.957 to 27.283, 40.660 to 40.700 MHz
Test Level: 6 Vrms
Power Frequency, Magnetic Immunity
Frequency: 50 Hz and 60 Hz
Applied Signal Level: 30 A/M RMS

40
VOLTAGE DIPS AND INTERRUPTS
100 VAC 60 Hz
Voltage
Voltage Test
Rated Frequency Test Duration
Specification Dip Voltage Result
Voltage (Hz) Level (Periods)
(%) (Vac)
(%)
0% UT for 0.5
100 60 0 100 0 0.5 Cycle (1)
Cycles @ 0°
0% UT for 0.5
100 60 0 100 0 0.5 Cycle (1)
Cycles @ 45°
0% UT for 0.5
100 60 0 100 0 0.5 Cycle (1)
Cycles @ 90°
0% UT for 0.5
100 60 0 100 0 0.5 Cycle (1)
Cycles @ 135°
0% UT for 0.5
100 60 0 100 0 0.5 Cycle (1)
Cycles @ 180°
0% UT for 0.5
100 60 0 100 0 0.5 Cycle (1)
Cycles @ 225°
0% UT for 0.5
100 60 0 100 0 0.5 Cycle (1)
Cycles @ 270°
0% UT for 0.5
100 60 0 100 0 0.5 Cycle (1)
Cycles @ 315°
0% UT for 1
100 60 0 100 0 1 Cycle (1)
Cycle @ 0°
70% UT for 30
100 60 70 30 70 30 Cycles (1)
Cycles @ 0°
0% UT for 300 300
100 60 0 100 0 (2)
Cycles @ 0° Cycles

41
 220 VAC 60 Hz
Voltage
Voltage Test
Rated Frequency Test Duration
Specification Dip Voltage Result
Voltage (Hz) Level (Periods)
(%) (Vac)
(%)
0% UT for 0.5
220 60 0 100 0 0.5 Cycle (1)
Cycles @ 0°
0% UT for 0.5
220 60 0 100 0 0.5 Cycle (1)
Cycles @ 45°
0% UT for 0.5
220 60 0 100 0 0.5 Cycle (1)
Cycles @ 90°
0% UT for 0.5
220 60 0 100 0 0.5 Cycle (1)
Cycles @ 135°
0% UT for 0.5
220 60 0 100 0 0.5 Cycle (1)
Cycles @ 180°
0% UT for 0.5
220 60 0 100 0 0.5 Cycle (1)
Cycles @ 225°
0% UT for 0.5
220 60 0 100 0 0.5 Cycle (1)
Cycles @ 270°
0% UT for 0.5
220 60 0 100 0 0.5 Cycle (1)
Cycles @ 315°
0% UT for 1
220 60 0 100 0 1 Cycle (1)
Cycle @ 0°
70% UT for 30
220 60 70 30 154 30 Cycles (1)
Cycles @ 0°
0% UT for 300 300
220 60 0 100 0 (2)
Cycles @ 0° Cycles

42
 240 VAC 50 Hz
Voltage
Voltage Test
Rated Frequency Test Duration
Specification Dip Voltage Result
Voltage (Hz) Level (Periods)
(%) (Vac)
(%)
0% UT for 0.5
240 50 0 100 0 0.5 Cycle (1)
Cycles @ 0°
0% UT for 0.5
240 50 0 100 0 0.5 Cycle (1)
Cycles @ 45°
0% UT for 0.5
240 50 0 100 0 0.5 Cycle (1)
Cycles @ 90°
0% UT for 0.5
240 50 0 100 0 0.5 Cycle (1)
Cycles @ 135°
0% UT for 0.5
240 50 0 100 0 0.5 Cycle (1)
Cycles @ 180°
0% UT for 0.5
240 50 0 100 0 0.5 Cycle (1)
Cycles @ 225°
0% UT for 0.5
240 50 0 100 0 0.5 Cycle (1)
Cycles @ 270°
0% UT for 0.5
240 50 0 100 0 0.5 Cycle (1)
Cycles @ 315°
0% UT for 1
240 50 0 100 0 1 Cycle (1)
Cycle @ 0°
70% UT for 25
240 50 70 30 168 25 Cycles (1)
Cycles @ 0°
0% UT for 250 250
240 50 0 100 0 (2)
Cycles @ 0° Cycles

Close Field Proximity Test Levels

Based on 0.3 m Separation Distance
Communication
Test Frequency Test Level Modulation
Service
(MHz) (volts/meter) ( @ 50% duty cycle)
(partial list)
385 27 18 Hz TETRA 400
FM
450 28 GMRS/FRS
(5 kHz deviation)
710, 745, 780 9 217 Hz LTE
810, 870, 930 28 18 Hz GSM 800
1720, 1845,
28 217 Hz GSM 1800
1970
2450 28 217 Hz RFID
5240, 5500,
9 217 Hz WLAN
5785

43
GUIDANCE AND MANUFACTURER’S DECLARATION
The VuPad is intended for use in the electromagnetic environment specified
below. The customer or user of the VuPad should ensure that it is used in
such an environment.
Electromagnetic Environment
Emissions Test Compliance
Guidance
Radiated Group 1 The VuPad uses RF energy only
RF Emissions for its internal function.
CISPR 11 Therefore, its RF emissions are
very low and are not likely to
cause any interference in nearby
electronic equipment.
Conducted Class B The VuPad is suitable for use in all
RF Emissions establishments, including
CISPR 11 domestic, and those directly
Harmonics Class A connected to the public low-
IEC 61000-3-2 voltage power supply network
Flicker Complies that supplies buildings used for
IEC 61000-3-3 domestic purposes.

The VuPad is intended for use in the electromagnetic environment specified

below. The customer or user of the VuPad should ensure that it is used in
such an environment.
IEC 60601 Compliance Electromagnetic
Immunity Test
Test Level Level Environment Guidance
Electrostatic ± 8kV ± 8kV Floors should be wood,
Discharge Contact Contact concrete or ceramic tile. If
[ESD] ± 15kV Air ± 15kV Air floors are covered with
IEC 61000-4-2 synthetic material, the
relative humidity should be
at least 30%.
Power 30 A/m 30 A/m Power frequency magnetic
Frequency fields should be at levels
[50/60 Hz] characteristic of a typical
IEC 61000-4-8 commercial or hospital
environment

44
The VuPad is intended for use in the electromagnetic environment specified
below. The customer or user of the VuPad should ensure that it is used in
such an environment.
IEC
Immunity 60601 Compliance Electromagnetic Environment
Test Test Level Guidance
Level
Conducted RF 10 V/m 10 V/m Portable and mobile RF
IEC 61000-4-6 150 kHz communications equipment
to 80 should be used no closer to any
MHz part of the VuPad, including
cables, than the recommended
separation distance calculated
from the equation applicable to
Radiated RF 10 V/m 10 V/m the frequency of the transmitter.
IEC 61000-4-3 80 MHz Recommended separation
to 2.7 distance
GHz d = 1.2√P
d = 1.2√P 80 MHz to 800 MHz
d = 1.2√P 800 MHz to 2.7 GHz

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 meters [m]. Field
strengths from fixed RF
transmitters, as determined by
an electromagnetic site survey, a
should be less than the
compliance level in each
frequency rangeb. Interference
may occur in the vicinity of
equipment marked with the
following symbol:

45
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic
propagation is affected by absorption and reflection from structures,
objects, and people.

a
Field strengths from fixed 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 fixed RF
transmitters, an electromagnetic site survey should be considered. If the
measured field strength in the location in which the VuPad is used exceeds
the applicable RF compliance level above, the VuPad should be observed to
verify normal operation. If abnormal performance is observed, additional
measures may be necessary, such as reorienting or relocating the VuPad.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less
than 10V/m.

46
WARNINGS AND CAUTIONS
WARNING: AN INSTRUCTION THAT DRAWS
ATTENTION TO RISK OF INJURY OR DEATH
DANGER!
THE WATER PATH PROBE IS A TYPE B APPLIED PART AND PROVIDES A BASIC
DEGREE OF PROTETION AGAINST ELECTRIC SHOCK AND HAS DIRECT EARTH
CONNECTION. WHEN USING THE WATER PATH PROBE IN UBM MODE (35 OR
50 MHZ), THE USER MUST TAKE EVERY PRECAUTION TO PREVENT THE
TRANSDUCER FROM TOUCHING THE EYE. CONTACT BETWEEN A MOVING
TRANSDUCER AND THE EYE CAN CAUSE SEVERE INJURY.

WARNINGS
Switching on a cold instrument near 0° Celsius may cause permanent damage.
Allow the instrument to reach a normal room temperature for half a day in
order to allow the internal elements to warm up and to avoid any thermal
shock hazards when switched on. The cover will quickly reach room
temperature, but not the internal circuitry.
To avoid the risk of electric shock, this equipment must only be connected to a
supply mains with protective earth. Isolation from the supply mains may be
achieved by disconnecting the main power cord from the supply outlet.
DO NOT disassemble, modify, or remodel the unit or accessories. This may
cause unit damage, malfunction, electrical shock, fire, or personal injury.
DO NOT attempt to repair or service this instrument. Any repair or service to
this instrument must be performed by experienced personnel who are trained
by Sonomed Escalon. Attempts to repair or service the instrument may result
in serious injury to the operator or patient.
Measurements should not be attempted when ocular integrity is questionable.
The user needs to exhibit care in manipulating the measurement tip. Force
should not be exerted against the eye.
Disconnect the AC POWER before cleaning the system.
If the device is used in the United States in the 240 volts mode, a Centered-
Tapped Single-Phase 240V power supply must be used.

47
The transducers are fragile. Dropping or striking any probe can cause
malfunctions; handle all probes with care. If a probe should be dropped,
inspect it carefully for chips and cracks, and make a “test” scan on a known
object. Damage to the front of the transducer will reduce efficiency, and may
cause premature failure of the electronics or may cause damage to the cornea.
DO NOT USE PROBES IT TIP DAMAGE IS NOTICED.
This device is not intended for fetal use.
Never autoclave a transducer or expose it to high heat.
Do not attempt to connect the device to any accessories or supplemental
equipment other than that provided by Sonomed Escalon. This could result in
increased electromagnetic emissions or decreased electromagnetic immunity
and result in improper operation. Equipment connected to the system must be
IEC 60601-1 or IEC 60950 compliant. Additionally, do not load any additional
software onto the system without prior authorization from Sonomed Escalon
(doing so may void warranty). Connection of system with a network is
responsibility of user, including assurance of data integrity and related
protections.
This equipment generates, uses, and can radiate radio frequency energy and, if
not installed and used in accordance with the instructions may cause harmful
interference to other devices in the vicinity. However, there is no guarantee
that interference will not occur in a particular installation. Harmful interference
to other devices can be determined by turning this equipment on or off. Try to
correct the interference using one or more of the following: Reorient or
relocate the receiving device, increase the separation between the equipment,
connect the equipment to an outlet on a different circuit from that to which
the other devices(s) are connected and or/ consult the factory field service
technician for help.
Portable radio frequency communications equipment (including antenna cables
and external cables) should be used no closer than 12 inches (30 cm) to any
part of the VuPad, including cables supplied by Sonomed Escalon. Otherwise,
degradation of the performance of this device could result.
Modifications to this instrument are not allowed. This may cause unit damage,
malfunction, electrical shock, fire, or personal and/or patient injury.
Do not use the device together with HF surgical equipment. HF surgical
equipment may be damaged, which may result in fire.

48
CAUTIONS
PATIENT DATA IS NOT SAVED IF UNIT IS TURNED OFF BEFORE SAVING SCANS
Data will be saved under the same patient name until another has been
selected.
Care should be taken by user to minimize exposure of patient to ultrasound
energy by keeping examinations as short as possible.
Position such that console is well ventilated with easy access to disconnect
power cords, and do not block the power adapter in the event that
disconnecting should be necessary.
Probes must be connected or disconnected only when the unit is switched OFF.
The unit should not be connected to a Multiple Power Switch Outlet (MPSO)
which is also used to provide power to devices not intended to be used in the
patient environment. Doing so may compromise electrical safety of the device.
Do not place the unit near heat sources such as a heater or opearate in the
presence of flammable anesthetics.
In order to prevent patient-to-patient transfer of infection, after each use
disinfect the measurement tip following accepted clinical procedures. Refer to
the Maintenance, Care and Service section regarding the use of disinfectants
and for probe cleaning instructions.
Dispose of all products in accordance with local and national regulations and
codes.
The VuPad conforms to the emissions and immunity requirements IEC 60601-1-
2:2014, Conducted Emissions, Group 1, Class B.
Essential performance of the VuPadmay be lost if the unit is adversely exposed
to external electromagnetic disturbances resulting in loss of patient data. When
tested for electromagnetic disturbances, the VuPad did not exhibit malfunction
or degradation of performance when subjected to power frequency magnetic
fields of 50 Hz and 60 Hz, but it is recommended that use in close proximity to
or stacking of other electronic devices should be avoided because it could
result in improper operation. If such use is necessary, the VuPad and other
equipment should be observed to verify normal operations.
In the event adverse external electromagnetic disturbances causes the VuPad
to lockup, the unit may require a system reboot by restarting.
Third Party Equipment: The use of third-party equipment, cables or
accessories, not made or authorized by Sonomed Escalon, invalidates the
warranty of the unit, and adversely affect the unit’s safe operation

49
CYBER SECURITY RECOMMENDATIONS
VuPad systems incorporate Microsoft 10 as the software Operating System, and, as
such, makes available to Operators the full scope of Microsoft Windows 10 security
features as defense against cyber security threats. Failure to maintain cyber
security could result in compromised device functionality, loss of data availability or
integrity, or exposure of other connected devices or networks to security threats.
Sonomed Escalon recommends the following minimum procedures be followed in
order to maintain a basic level of cyber security:
① Utilize Device Only for Intended Use. Limit or prohibit use of device for any
purpose other than ophthalmic ultrasound, including internet browsing and
email, to limit potential exposure to cyber security risks.
② Verify Windows 10 Firewall is Enabled. Devices are shipped from the factory
with the Windows Firewall on by default. To make sure it hasn’t been turned
off, follow these steps:
1. Open Windows Firewall by clicking the Start button and then clicking the
Search icon. In the search box, type firewall, and then click Windows
Firewall.
2. In left pane, click Turn Windows Firewall On or Off. If prompted for an
administrator password or confirmation, type password or provide
confirmation.
3. Below each network location type, click Turn On Windows Firewall, and
then click OK. It is recommended that the firewall be turned on for all
network location types.
IMPORTANT: If device is connected to a network, ensure that the device is
placed behind a strong network firewall.
③ Verify Automatic Updating for Windows 10 Operating System Enabled.
With automatic updating, the Operator doesn’t have to search for updates
online or worry that critical fixes or device drivers for Windows might be
missing from the system. Windows update automatically installs important
updates as they become available. The Operator can also set Windows
Update to install recommended updates automatically or to inform the
Operator that they’re available. The Operator can also choose whether to
turn on Microsoft Update, which delivers updates for other Microsoft
products. Optional updates, such as language packs and updates from
Microsoft Update, aren’t installed automatically. Windows Update won’t add
any apps to the system without prompting for permission.

50
 To turn on automatic updating:
1. Open Windows Update by swiping in from the right edge of the screen
(or, if using a mouse, pointing to the lower-right corner of the screen and
moving the mouse pointer up), tapping or clicking Settings, tapping or
clicking Control Panel, and then tapping or clicking Windows Update.
2. Tap or click Change Settings.
3. Under Important Updates, choose the option that you want.
4. Under Recommended Updates, select the Give me recommended
updates the same way I received important updates check box, then
click Apply.
IMPORTANT: In order for automatic Windows Update to function, the device
must be continuously connected to the Internet. If the device is not
connected, Windows updates will need to be performed manually. To do so,
regularly go to Windows Update per step 1 above and then click Check and
Install Updates button.
④ Install Windows 10 Compatible Anti-Virus Program. The Operator should
utilize an antivirus and antimalware program, and keep it current by regularly
downloading updates from the program manufacturer’s website. Many of
these programs update automatically and can help protect the system from
spyware and malicious software.
⑤ Enable Windows 10 BitLocker. The Operator can use BitLocker Drive
Encryption to help protect files on the entirety of the drive. BitLocker can
help block hackers from accessing the system files they rely on to access
sensitive data, or from accessing a disk drive by physically removing it from
the system and installing it in a different one. New files are automatically
encrypted when added to the disk drive that used BitLocker. However, if
these files are copied to another drive or a different PC, they’re automatically
decrypted. BitLocker can encrypt the drive Windows is installed on (the
operating system drive) as well as fixed data drives (such as internal hard
drives). The Operator can also use BitLocker To Go to help protect all files
stored on a removable data drive (such as an external hard drive or USB flash
drive).
For more information on cyber security, please consult your IT support staff
and/or visit Microsoft security www.microsoft.com/security.

51
WARRANTY
Sonomed Escalon warrants its products are free of defects of labor and
material for two (2) years for consoles, one (1) year for probes and cables, and
one (1) year for associated computer components such as monitors, keyboards,
and mice.

The following items are not covered:

Physical damage to the console or probes due to misuse or shock.

Damage or data loss due to power failures or fluctuations. The use of a line-
interactive UPS is recommended to avoid this type of failure.

Loss or corruption of data or software due to user error or the installation or

use of any third-party hardware or software.

Damage to transducers caused by autoclaving or exposure to excessive heat.

Repairs not covered by warranty will be invoiced on the basis of parts and
labor. At Sonomed Escalon’s discretion, the damaged component may be
exchanged at a flat rate.

Servicing of the unit may only be performed by Technicians certified by

Sonomed Escalon. For additional information regarding system repair,
maintenance, or exchange please contact US:

Sonomed Escalon
1979 Marcus Avenue, C105
Lake Success, NY 11042 USA
Tel: 800-227-1285
Fax: 516-354-5902
www.sonomedescalon.com

52
NETWORKING
Sonomed Escalon does not provide support for the operation of this product in
a network environment. Connection to and operation on any network is
entirely the responsibility of the user. Where installation or use of any network
hardware or software interferes with the normal operation of this Sonomed
Escalon-supplied product, that product must be returned to normal operation
at the user’s expense. When the connection of this product to, or installation of
Sonomed Escalon supplied software on, a network interferes with the
operation of the network, the product must be removed from the network;
alternatively, the problem may be resolved by the user in cooperation with the
network owner, at their expense.

THIRD-PARTY SOFTWARE
Sonomed Escalon does not provide support for the use or installation of any
software obtained from a third party on its products, including, but not limited
to, operating system upgrades and device drivers. When software not supplied
by Sonomed Escalon interferes with the operation of the system, the product
will be returned to its original condition at the user’s expense. Sonomed
Escalon may occasionally furnish to users software not directly related to the
functioning of its products. Such software is supplied as is, without warranty of
any kind, and the availability of support for such software is at Sonomed
Escalon’s sole discretion..

53
SYMBOLS
USB Port

Do Not Dispose of Equipment in Normal Waste Stream

CE Mark; Device complies with New Approach Directives:

93/42/EEC Medical Devices

Type BF Applied Part

(B Scan Probe)

Type B Applied Part

(Water Path Probe / A Scan Probes / Pachymeter Probe)

Warnings and Cautions, Read Accompanying Documents

Protected Against Effects of Temporary Immersion in Water

IPX7 (Note: Rating Applies to Ultrasound Probes Only)
Do not immerse probe electrical connectors.
Rating applies to VuPad Base Unit only. An IPX1 designation
IPX1 means the device enclosure is resistant to the ingression of
water at a flow rate of 1mm/min for 10 minutes.

Class II Equipment per IEC EN 60601-1

ETL Listing Mark

C  
US


Refer to Operator’s Manual

Document No. 5575-1901-E, Aug 2019 (ECO 1449)

54