Sonomed Escalon VuPad Operators Manual

OPERATOR’S MANUAL

2

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

3

CONTACT INFORMATION

Sonomed, Inc.
1979 Marcus Avenue, C105
Lake Success, NY 11042, U.S.A.
Tel: [phone]
Tel: [phone]
Fax: [phone]

[e-mail]
www.sonomedescalon.com

Authorized Representative for Medical Devcie Directive:
Emergo Europe

Prinsessegracht 20
2514 AP The Hague
The Netherlands
Tel: [phone]
Fax: [phone]

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

4

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.

5

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, two­dimensional 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.

6

GETTING STARTED

SYSTEM COMPONENTS

PROBES

B-Probe
(12 or 20 MHz Probes)

Water Path Probe
(with 35 or 50 MHz Transducers)

A-Probe 10 MHz

Foot Pedal

Power
On/Off

Ethernet

USB

Power
Cable

7

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 [e-mail].

8

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.

9

Fig. 1

Examiner Lens Selection

Master Lens Database Tab

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.

10

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.

11

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.

12

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.

13

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.

A-scan

Calculations

Reports

14

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.

15

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

16

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

17

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.

18

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

19

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

20

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

21

REPORT

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

Fig 15

22

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.

23

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 set­up tasks.

24

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.

25

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 auto­generated 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.

26

IMAGE CONTROLS

TVG

Time Variable Gain (TVG) attenuates near field portion of
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.

Exp Gain

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

UBM PRESET MODES

Sulcus-

to-Sulcus

Optimized to measure sulcus-to-sulcus for lens sizing with wide
30° scan angle. Note: When measuring sulcus-to-sulcus, ensure
iris plane is saturated, with anterior and posterior lens echoes
visible. It is advisable to perform multiple scans with
measurements to ensure most accurate results.

Angle
Detail

With scan angle of 15° and mid-range settings for gain and scan
frequency, optimized to provide excellent detail of angle
structures, tumors, traumas, and fine details.

B-SCAN PRESET MODES

Orbit

Optimized to image the orbit with 50° scan angle.

Deep
Retina /
Choroid

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

27

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.

28

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

29

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

30

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: [e-mail]

31

SPECIFICATIONS

A-SCAN SPECIFICATIONS

Ultrasound
Probes

Sealed 10 MHz focused transducer with standard probe
(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, Hoffer­Q, 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
Probes

B-Scan: HD series of sealed B-scan probes with focused
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
Rendering

Enhanced Focus Rendering™ (EFR™) with continuous interpolative

zoom re-renders at each magnification level for optimized image
quality (up to 8x zoom)

Scan Position
Indicators

B-Scan One-click selection of transverse or longitudinal scan clock
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)

32

UBM / B-SCAN SPECIFICATIONS (cont’d)

Preset Scan
Settings

UBM: Selectable preset scan setting profiles to optimize image
quality for each frequency probe: high resolution, sulcus-to-sulcus,
angle detail, and motion picture

2D Scan
Sampling

256 ray scan with 2048 sample points for each ray (524,288
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
Probes

Sealed 20 MHz focused transducer with standard probe
(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
Analysis

Average of 128 individual measures for each reading
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
Precision

± 1 micron

Measurement
Accuracy

5 microns

Customizable
Parameters

Corneal Velocity: 1620 – 1650 m/s
Measurement Bias: 80 -120 %
Intra-Ocular Pressure Correction (IOP) formula

Amplifier

Low Noise
Automatic Gain Control
Maximum Gain = 46 dB

33

GENERAL SPECIFICATIONS

Patient Exam
Records

Searchable patient database with exam record storage and
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 High­Definition 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
System

Microsoft Windows 10

Power

100-120 / 200-240 V
4 / 2 A
60 / 50 Hz
Auto-switching medical-grade power supply (250 W power
consumption, typical)
(max length 6 ft cord)

Operating
Conditions

Operating Temperature: 41 to 104°F (5 to 40°C)
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
Frequency

5150 – 5350 MHz

Bandwidth

802.11 a/n/ac: 20/40/80/MHz

RF Output
Power

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

34

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.

35

Probe

35 MHz Transducer

50 MHz Transducer

Mode

B-Mode (UBM)

B-Mode (UBM)

Material

Gold-plated polymer
membrane

Gold-plated polymer
membrane

Nominal Center
Frequency

35 MHz

50 MHz

Pule Repetition
Frequency

2560 Hz

2560 Hz

Type

B-Scan
(energy emitted during active
scan)

B-Scan
(energy emitted during active
scan)

Measure

MI
[no units]

I

SPTA.3

[mW/cm2]

MI
[no units]

I

SPTA.3

[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
Deviation

0.0070

0.0030

0.0040

0.0004

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
Frequency

12 MHz

20 MHz

Pule Repetition
Frequency

2560 Hz

2560 Hz

Type

B-Scan
(energy emitted during active
scan)

B-Scan
(energy emitted during active
scan)

Measure

MI
[no units]

I

SPTA.3

[mW/cm2]

MI
[no units]

I

SPTA.3

[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
Deviation

0.0154

0.0260

0.0117

0.0504
Limit

0.215

0.216

0.184

0.455

36

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
[no units]

I

SPTA.3

[mW/cm2]

Sample Size

3.0

3.0

K 4.258

4.258

Mean

0.186

7.82

Standard
Deviation

.00458

0.570

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
[no units]

I

SPTA.3

[mW/cm2]

Sample Size

3.0

3.0

K 4.258

4.258

Mean

0.0683

4.02

Standard
Deviation

0.00681

0.809

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.

37

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.

Transducer Model

Sonomed Escalon 10 MHz Probe
(s/n D09A655)

Operating Mode

A-Mode

Application

Ophthalmic

Acoustic Output

MI
[no units]

I

SPTA.3

[mW/cm2]

I

SPPA.3

[W/cm2]

Global Maximum Value

0.190

8.42

8.52

Associated
Acoustic
Parameters

Pr.3 [Mpa]

0.531

W0 [mW]

0.538

0.538

fc [MHz]

7.80

7.80

7.80

Zsp [cm]

1.90

1.90

1.90

Beam
Dimensions

x-6 [cm]

0.177

0.177

y-6 [cm]

0.162

0.162

PD [µS]

0.168

0.168

PRF [Hz]

5880

5880

EDS
Az [cm]

0.47 Ele. [cm]

0.47

Transducer Model

Sonomed Escalon 12 MHz Probe
(s/n 22064)

Operating Mode

B-Mode

Application

Ophthalmic

Acoustic Output

MI
[no units]

I

SPTA.3

[mW/cm2]

I

SPPA.3

[W/cm2]

Global Maximum Value

0.167

0.135

12.9

Associated
Acoustic
Parameters

Pr.3 [Mpa]

W0 [mW]

0.0832

0.0832

fc [MHz]

12.2

12.2

12.2

Zsp [cm]

1.60 1.60

Beam
Dimensions

x-6 [cm]

0.0689

y-6 [cm]

0.0824

PD [µS]

0.131

0.131

PRF [Hz]

2560

2560

EDS
Az [cm]

0.600

Ele. [cm]

0.600

Operating Control Conditions

Scan angle 60°
256 lines per frame
Scan rate 10 Hz

38

Transducer Model

Sonomed Escalon 20 MHz Probe
(s/n 22160)

Operating Mode

B-Mode

Application

Ophthalmic

Acoustic Output

MI
[no units]

I

SPTA.3

[mW/cm2]

I

SPPA.3

[W/cm2]

Global Maximum Value

0.122

0.184

11.5

Associated
Acoustic
Parameters

Pr.3 [Mpa]

0.456

W0 [mW]

0.0296

0.003

fc [MHz]

14.0

14.0

14.0

Zsp [cm]

1.70 1.70

Beam
Dimensions

x-6 [cm]

0.0601

y-6 [cm]

0.0605

PD [µS]

0.0650

0.0650

PRF [Hz]

2560

2560

EDS
Az [cm]

0.7 Ele. [cm]

0.7

Operating Control Conditions

Scan angle 60°
256 lines per frame
Scan rate 10 Hz

Transducer Model

Sonomed Escalon 35 MHz Transducer
(s/n 35-00219)

Operating Mode

B-Mode

Application

Ophthalmic

Acoustic Output

MI
[no units]

I

SPTA.3

[mW/cm2]

I

SPPA.3

[W/cm2]

Global Maximum Value

0.094

0.028

4.780

Associated
Acoustic
Parameters

Pr.3 [Mpa]

0.460

W0 [mW]

0.003

0.003

fc [MHz]

24.095

24.095

24.095

Zsp [cm]

1.000

1.000

Beam
Dimensions

x-6 [cm]

0.039

y-6 [cm]

0.038

PD [µS]

0.043

0.043

PRF [Hz]

2560

2560

EDS
Az [cm]

0.7 Ele. [cm]

0.7

Operating Control Conditions

Scan angle 15°
256 lines per frame
Scan rate 10 MHz

39

Transducer Model

Sonomed Escalon 50 MHz Transducer
(s/n 50-00376)

Operating Mode

B-Mode

Application

Ophthalmic

Acoustic Output

MI
[no units]

I

SPTA.3

[mW/cm2]

I

SPPA.3

[W/cm2]

Global Maximum Value

0.019

0.001

0.190

Associated
Acoustic
Parameters

Pr.3 [Mpa]

0.112

W0 [mW]

0.0003

0.0003

fc [MHz]

34.168

34.168

34.168

Zsp [cm]

1.000

1.000

Beam
Dimensions

x-6 [cm]

0.035

y-6 [cm]

0.041

PD [µS]

0.056

0.056

PRF [Hz]

2560

2560

EDS
Az [cm]

0.7 Ele. [cm]

0.7

Operating Control Conditions

Scan angle 15°
256 lines per frame
Scan rate 10 MHz

Transducer Model

Sonomed Escalon 20 MHz Pachymeter
Probe
(s/n PD20.0-0108-0341)

Operating Mode

A-Mode

Application

Ophthalmic

Acoustic Output

MI
[no units]

I

SPTA.3

[mW/cm2]

I

SPPA.3

[W/cm2]

Global Maximum Value

0.0760

4.91

3.69

Associated
Acoustic
Parameters

Pr.3 [Mpa]

0.323

W0 [mW]

0.236

0.236

fc [MHz]

17.9

17.9

17.9

Zsp [cm]

1.00

1.00

1.00

Beam
Dimensions

x-6 [cm]

0.153

0.153

y-6 [cm]

0.142

0.142

PD [µS]

0.0780

0.0780

PRF [Hz]

1.70E+4

1.70E+4

EDS
Az [cm]

0.2 Ele. [cm]

0.2

40

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

41

VOLTAGE DIPS AND INTERRUPTS

100 VAC 60 Hz

Specification

Rated

Voltage

Frequency

(Hz)

Voltage

Test

Level

(%)

Voltage

Dip
(%)

Test

Voltage

(Vac)

Duration
(Periods)

Result

0% UT for 0.5
Cycles @ 0°

100

60 0 100

0

0.5 Cycle

(1)

0% UT for 0.5
Cycles @ 45°

100

60 0 100

0

0.5 Cycle

(1)

0% UT for 0.5
Cycles @ 90°

100

60 0 100

0

0.5 Cycle

(1)

0% UT for 0.5
Cycles @ 135°

100

60 0 100

0

0.5 Cycle

(1)

0% UT for 0.5
Cycles @ 180°

100

60 0 100

0

0.5 Cycle

(1)

0% UT for 0.5
Cycles @ 225°

100

60 0 100

0

0.5 Cycle

(1)

0% UT for 0.5
Cycles @ 270°

100

60 0 100

0

0.5 Cycle

(1)

0% UT for 0.5
Cycles @ 315°

100

60 0 100

0

0.5 Cycle

(1)

0% UT for 1
Cycle @ 0°

100

60 0 100 0 1 Cycle

(1)

70% UT for 30
Cycles @ 0°

100

60

70

30

70

30 Cycles

(1)

0% UT for 300
Cycles @ 0°

100

60 0 100

0

300

Cycles

(2)

42

220 VAC 60 Hz

Specification

Rated

Voltage

Frequency

(Hz)

Voltage

Test

Level

(%)

Voltage

Dip

(%)

Test

Voltage

(Vac)

Duration
(Periods)

Result

0% UT for 0.5
Cycles @ 0°

220

60 0 100

0

0.5 Cycle

(1)

0% UT for 0.5
Cycles @ 45°

220

60 0 100

0

0.5 Cycle

(1)

0% UT for 0.5
Cycles @ 90°

220

60 0 100

0

0.5 Cycle

(1)

0% UT for 0.5
Cycles @ 135°

220

60 0 100

0

0.5 Cycle

(1)

0% UT for 0.5
Cycles @ 180°

220

60 0 100

0

0.5 Cycle

(1)

0% UT for 0.5
Cycles @ 225°

220

60 0 100

0

0.5 Cycle

(1)

0% UT for 0.5
Cycles @ 270°

220

60 0 100

0

0.5 Cycle

(1)

0% UT for 0.5
Cycles @ 315°

220

60 0 100

0

0.5 Cycle

(1)

0% UT for 1
Cycle @ 0°

220

60 0 100 0 1 Cycle

(1)

70% UT for 30
Cycles @ 0°

220

60

70

30

154

30 Cycles

(1)

0% UT for 300
Cycles @ 0°

220

60 0 100

0

300

Cycles

(2)

43

240 VAC 50 Hz

Specification

Rated

Voltage

Frequency

(Hz)

Voltage

Test

Level

(%)

Voltage

Dip

(%)

Test

Voltage

(Vac)

Duration
(Periods)

Result

0% UT for 0.5
Cycles @ 0°

240

50 0 100

0

0.5 Cycle

(1)

0% UT for 0.5
Cycles @ 45°

240

50 0 100

0

0.5 Cycle

(1)

0% UT for 0.5
Cycles @ 90°

240

50 0 100

0

0.5 Cycle

(1)

0% UT for 0.5
Cycles @ 135°

240

50 0 100

0

0.5 Cycle

(1)

0% UT for 0.5
Cycles @ 180°

240

50 0 100

0

0.5 Cycle

(1)

0% UT for 0.5
Cycles @ 225°

240

50 0 100

0

0.5 Cycle

(1)

0% UT for 0.5
Cycles @ 270°

240

50 0 100

0

0.5 Cycle

(1)

0% UT for 0.5
Cycles @ 315°

240

50 0 100

0

0.5 Cycle

(1)

0% UT for 1
Cycle @ 0°

240

50 0 100 0 1 Cycle

(1)

70% UT for 25
Cycles @ 0°

240

50

70

30

168

25 Cycles

(1)

0% UT for 250
Cycles @ 0°

240

50 0 100

0

250

Cycles

(2)

Close Field Proximity Test Levels

Based on 0.3 m Separation Distance

Test Frequency

(MHz)

Test Level

(volts/meter)

Modulation

( @ 50% duty cycle)

Communication

Service

(partial list)

385

27

18 Hz

TETRA 400

450

28

FM

(5 kHz deviation)

GMRS/FRS

710, 745, 780

9

217 Hz

LTE

810, 870, 930

28

18 Hz

GSM 800

1720, 1845,

1970

28

217 Hz

GSM 1800

2450

28

217 Hz

RFID

5240, 5500,

5785

9

217 Hz

WLAN

44

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.

Emissions Test

Compliance

Electromagnetic Environment

Guidance

Radiated
RF Emissions
CISPR 11

Group 1

The VuPad uses RF energy only
for its internal function.
Therefore, its RF emissions are
very low and are not likely to
cause any interference in nearby
electronic equipment.

Conducted
RF Emissions
CISPR 11

Class B

The VuPad is suitable for use in all
establishments, including
domestic, and those directly
connected to the public low­voltage power supply network
that supplies buildings used for
domestic purposes.

Harmonics
IEC 61000-3-2

Class A

Flicker
IEC 61000-3-3

Complies

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.

Immunity Test

IEC 60601
Test Level

Compliance

Level

Electromagnetic

Environment Guidance

Electrostatic
Discharge
[ESD]
IEC 61000-4-2

± 8kV
Contact
± 15kV Air

± 8kV
Contact
± 15kV Air

Floors should be wood,
concrete or ceramic tile. If
floors are covered with
synthetic material, the
relative humidity should be
at least 30%.

Power
Frequency
[50/60 Hz]
IEC 61000-4-8

30 A/m

30 A/m

Power frequency magnetic
fields should be at levels
characteristic of a typical
commercial or hospital
environment

45

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.

Immunity

Test

IEC

60601

Test

Level

Compliance

Level

Electromagnetic Environment

Guidance

Conducted RF
IEC 61000-4-6

10 V/m
150 kHz
to 80
MHz

10 V/m

Portable and mobile RF
communications equipment
should be used no closer to any
part of the VuPad, including
cables, than the recommended
separation distance calculated
from the equation applicable to
the frequency of the transmitter.
Recommended separation
distance

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:

Radiated RF
IEC 61000-4-3

10 V/m
80 MHz
to 2.7
GHz

10 V/m

46

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.

47

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.

48

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.

49

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 60601-1­2:2014, 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

50

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.

51

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.

52

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 line­interactive 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: [phone]
Fax: [phone]
www.sonomedescalon.com

53

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..

54

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

IPX7

Protected Against Effects of Temporary Immersion in Water
(Note: Rating Applies to Ultrasound Probes Only)
Do not immerse probe electrical connectors.

IPX1

Rating applies to VuPad Base Unit only. An IPX1 designation
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

Refer to Operator’s Manual

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

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US