Diversatek Healthcare inSIGHT Ultima User manual

Central Unit for
Zvu®Manometry
Installation and User’s Guide
Part Number: H12R-0195 Rev.7
Diversatek Healthcare
Technical Research & Training Center
9150 Commerce Center Circle, Suite 500
Highlands Ranch, CO 80129 USA
P800.558.6408 or 303.470.7020
DiversatekHealthcare.com

inSIGHT Ultima®System with ZVU®
Installation and User’s Guide
H12R-0195 Rev. 7, Edited 22 September 2022, ECO 220-012 ii
Notes, Notices, and Cautions in User’s Guide
NOTE:
A NOTE indicates important information that helps you make better use of
your system.
NOTICE:
A NOTICE indicates either potential damage to hardware or loss of data and
tells you how to avoid the problem.
CAUTION:
A CAUTION indicates a potential for property damage, personal injury, or
death.
Symbols Marked On Devices
Refer to Instruction
Manual:
The operator must read, understand, and follow all instructions in the
accompanying documents including all warnings, cautions, and precautions
before using the medical device.
General Warning Sign:
General warning sign to alert the user to potential hazards.
Use-By Date (YYYY-
MM-DD):
Expiration date for single use and reusable catheters.
Do Not Reuse:
Marked on single use devices.
Non-Sterile:
The product associated with this symbol is not sterilized after
manufacturing.
No Pushing:
Do not push at this location. Doing so may cause the cart to overbalance
and become unstable.
EC Representative:
Authorized Representative in EU
Manufacturer:
Name and address of device manufacturer.
Serial Number:
The manufacturer’s serial number uniquely identifying the device.
Part / Reference Number:
The manufacturer’s part number of the device for re-order.
Medical Device:
Indication the device is a medical device.
Direct Current Voltage:
The type of input voltage required by the device and the voltage levels
needed.
Do Not Discard:
The device contains electronics and must be disposed of in accordance with
local regulations.

inSIGHT Ultima®System with ZVU®
Installation and User’s Guide
H12R-0195 Rev. 7, Edited 22 September 2022, ECO 220-012 iii
inSIGHT Central Unit Classifications
Type BF Applied Part:
This symbol indicates that the patient applied part is Type BF, (floating from
electrical ground) which offers a specific level of safety.
Power Source
Classification:
Class I Equipment - Requires protective earth grounding.
Ingress Protection:
Not protected against ingress of moisture. Equipment is not suitable for use
with flammable anesthetics.
Rx Only
Prescription Only:
Device restricted for use by or on the order of a physician.
Definitions, Abbreviations and Acronyms
A/D:
Analog-to-Digital converter; an electronic circuit or device that converts an analog input signal into a
digital signal. A channel on a Catheter produces analog output. The inSIGHT converts that output to digital
data and saves it to the patient’s data file. The A/D channel refers to the Catheter channel.
HRiM:
High Resolution Impedance Manometry.
inSIGHT
inSIGHT peripheral acquisition system.
LCD:
A computer monitor which uses a liquid crystal display to display the output of a computer to the user.
USB:
Universal Serial Bus. USB is a standard data I/O interface that enables the user to connect peripheral
devices to a personal computer.
Catheter (Probe)
Patient applied sensor device.

inSIGHT Ultima®System with ZVU®
Installation and User’s Guide
H12R-0195 Rev. 7, Edited 22 September 2022, ECO 220-012 iv
© Copyright 2022 by Diversatek Healthcare.
All rights reserved. Reproduction in any manner whatsoever without the written permission of Diversatek
Healthcare is strictly forbidden.
DISCLAIMER: The information in this manual is subject to change without notice. Diversatek Healthcare makes
no representations or warranties with respect to the contents hereof, and specifically disclaims any implied
warranties of merchantability or fitness for a particular purpose. Diversatek Healthcare reserves the right to revise
this publication and to make changes from time to time in the content hereof without obligation of Diversatek
Healthcare to notify any person of such revisions or changes.
Trademarks used in this text: inSIGHT, inSIGHT Ultima, ZVU, BioVIEW, and HRiM are trademarks of Diversatek
Healthcare; Dell is a trademark of Dell Inc.; Intel, Pentium are registered trademarks of Intel Corporation; Microsoft
and Windows are registered trademarks of Microsoft Corporation.
Other trademarks and trade names may be used in this document to refer to either the entities claiming the marks
and names or their products. Diversatek Healthcare disclaims any proprietary interest in trademarks and trade
names other than its own.

inSIGHT Ultima®System with ZVU®
Installation and User’s Guide
H12R-0195 Rev. 7, Edited 22 September 2022, ECO 220-012 v
Contents
1Introduction .........................................................................................................................................................1
1.1 HOW TO USE THIS GUIDE...............................................................................................................................1
1.2 CAUTION: SAFETY INSTRUCTIONS ..............................................................................................................2
1.3 PRODUCT DESCRIPTION..................................................................................................................................5
1.3.1 Indications of Use..................................................................................................................................5
1.3.2 Contraindications ..................................................................................................................................5
1.3.3 Features.................................................................................................................................................5
1.3.4 Biocompatibility.....................................................................................................................................5
2System Components ............................................................................................................................................6
2.1 USER MANUALS .............................................................................................................................................6
2.2 MAIN SYSTEM COMPONENTS .........................................................................................................................6
2.3 CONFIGURATIONS...........................................................................................................................................6
2.3.1 Cart Configuration ................................................................................................................................7
2.3.2 Desktop Configuration...........................................................................................................................8
2.4ELECTRICAL CONFIGURATION........................................................................................................................9
2.5 ISOLATION TRANSFORMER SETUP (FOR DESKTOP CONFIGURATION)..............................................................9
2.5.1 Voltage Settings (for Desktop Configuration) .....................................................................................10
2.6 CONNECTING THE SYSTEM TO A DATA NETWORK........................................................................................11
3Controls and Connections.................................................................................................................................12
3.1 INSIGHT ULTIMA CENTRAL UNIT ...............................................................................................................12
3.1.1 Ports, Switches and Indicators ............................................................................................................13
3.1.2 Automated Air Calibration ..................................................................................................................14
3.2 SIGNAL CONDITIONING UNITS......................................................................................................................15
3.2.1 High Resolution Catheter Adapter.......................................................................................................15
3.3 SYSTEM CART ..............................................................................................................................................16
3.3.1 Adjustable Working Height..................................................................................................................16
3.3.2 Monitor Adjustments............................................................................................................................17
3.3.3 Casters and Caster Locks ....................................................................................................................18
3.3.4 Moving the Cart...................................................................................................................................19
3.4 BASIC OPERATION OF THE SYSTEM ..............................................................................................................20
3.4.1 Plugging in the System.........................................................................................................................20
3.4.2 Turning On the System.........................................................................................................................20
3.4.3 Turning Off the System ........................................................................................................................20
4Software..............................................................................................................................................................21
4.1 SYSTEM REQUIREMENTS ..............................................................................................................................21
4.2 SOFTWARE INSTALLATION INSTRUCTIONS ...................................................................................................21
4.3 SOFTWARE ACTIVATION...............................................................................................................................22
4.4 SOFTWARE UPGRADES .................................................................................................................................22
4.5 SECURITY AND AUTHENTICATION................................................................................................................22
5Cleaning and Preventative Maintenance.........................................................................................................23
5.1 CLEANING PROCEDURE ................................................................................................................................23
5.1.1 inSIGHT Ultima, Cart, and Accessories..............................................................................................23
5.1.2 Calibration Tubes................................................................................................................................23
5.1.3 Probe Case Cleaning...........................................................................................................................23
5.2 AIR CALIBRATION TUBE SEALS....................................................................................................................24
5.3 PREVENTATIVE MAINTENANCE....................................................................................................................25
5.4 SERVICE .......................................................................................................................................................25
5.5 DECOMMISSIONING AND DISPOSAL ..............................................................................................................25
6Appendix ............................................................................................................................................................26

inSIGHT Ultima®System with ZVU®
Installation and User’s Guide
H12R-0195 Rev. 7, Edited 22 September 2022, ECO 220-012 vi
6.1 TECHNICAL SUPPORT ...................................................................................................................................26
6.2 DECLARATION OF CONFORMITY...................................................................................................................27
6.3 EMC INFORMATION .....................................................................................................................................28
6.3.1 Electromagnetic Emissions..................................................................................................................28
6.3.2 Electromagnetic Immunity...................................................................................................................29
6.3.3 Recommended Separation Distances...................................................................................................31
6.4 SPECIFICATIONS ...........................................................................................................................................32
6.4.1 inSIGHT Ultima Central Unit..............................................................................................................32
6.4.2 Isolation Transformer..........................................................................................................................32
6.4.3 Cart......................................................................................................................................................33

inSIGHT Ultima®System with ZVU®
Installation and User’s Guide
H12R-0195 Rev. 7, Edited 22 September 2022, ECO 220-012 1
1 Introduction
1.1 How to Use This Guide
This guide is designed to help you install the inSIGHT Ultima system and the ZVU software quickly and easily. It is
intended for health-care professionals trained in performing clinical procedures. Regularly scheduled clinical
training courses are offered for your convenience. See contact information on the cover page or in Section 6.1:
Technical Support.
CAUTION: The assembly and installation of a rolling cart system must be performed by a
trained manufacturer’s representative since some assembly is required.
For detailed instructions on using the inSIGHT Ultima System and ZVU Software refer to the help screens
incorporated into the software.
This User’s Guide assumes the user has the following basic computer skills common to Microsoft software
applications:
•Mouse click and double-click. If using a touch screen, then touching the screen is the same as a mouse click and
touching the screen twice in rapid succession in the same spot is the same as a double-click.
•Open desktop folders and double-click desktop icons to invoke applications.
•Use Windows Explorer to browse and manage files and folders.
•Maximize, minimize, resize, and move application windows.
•Use dialog boxes and message boxes.
•Use menu bars to execute menu commands.
This guide uses visual clues and typographical conventions to attract attention to, and clarify instructions.
Keyboard keystrokes are written in bold face.
Labels in the software such as a menu, toolbar, button, shortcut names, etc. are written in italics.
The guide is divided into different sections featuring specialized tasks for quick, easy reference.

inSIGHT Ultima®System with ZVU®
Installation and User’s Guide
H12R-0195 Rev. 7, Edited 22 September 2022, ECO 220-012 2
1.2 CAUTION: Safety Instructions
The inSIGHT Ultima System and the accompanying signal conditioning devices are sensitive electronic instruments.
Please use the following safety guidelines to help ensure your own personal safety and to help protect your inSIGHT
System and working environment from potential damage.
CAUTION: The user must be qualified in gastrointestinal diagnostic procedures, trained in the use of
the system, and must be familiar with all labeling and instruction for use associated with
the equipment. Many device injuries are due to user error and failure to follow the
instructions for use. The user of the device is advised to thoroughly understand the use
of the equipment, and familiarize themselves with the location and function of all
controls and alarms prior to using the equipment.
CAUTION: The inSIGHT System is intended for use by gastroenterologists, surgeons, other trained
physicians, and medically trained personnel as an aid in documenting and diagnosing
digestive disorders. This system includes analysis software, but requires skilled
interpretation by a physician to make a diagnosis.
CAUTION: The assembly and installation of a rolling cart system must be performed by a trained
manufacturer’s representative.
CAUTION: Do not get the inSIGHT System or signal conditioning devices wet - these devices are
not waterproof.
CAUTION: Plug the inSIGHT System into voltages as stated on the InSIGHT Ultima Central Unit
Nameplate.
CAUTION: To avoid the risk of electric shock, this equipment must only be connected to an AC
Main supply with protective earth ground. This equipment is not intended to receive AC
mains power from any other device.
CAUTION: For Desktop Systems: The inSIGHT System must receive AC Main power supply from
a medical grade isolation transformer. The isolating transformer is specified as a part of
the Medical Electrical System.
CAUTION: For Desktop Systems: Warning: Connecting electrical equipment to multiple socket
outlets effectively leads to creating a Medical Equipment System, and can result in a
reduced level of safety. Do not use the socket outlets for other devices that are not part
of the inSIGHT System.
CAUTION: For Desktop Systems: Do not plug another multiple socket outlet power strip into the
accessory outlets provided with the isolation transformer. Only the devices provided
with the inSIGHT System should be powered through the isolation transformer.
CAUTION: Do not attempt to open or service the inSIGHT System or signal conditioning devices.
There are no user serviceable parts inside.
CAUTION: No modification of this equipment is allowed.
CAUTION: Follow instructions provided with all types of catheters used with the inSIGHT System
and Signal Conditioning devices.
CAUTION: Discard all used disposable catheters in accordance with local biohazard requirements.
Refer to section 5.5 Decommissioning and Disposal for additional information.
CAUTION: Reusable catheters should be cleaned and disinfected according to manufacturer’s and
your institution’s guidelines after each use.

inSIGHT Ultima®System with ZVU®
Installation and User’s Guide
H12R-0195 Rev. 7, Edited 22 September 2022, ECO 220-012 3
CAUTION: Dispose of the inSIGHT System and signal conditioning device in accordance with local
ordinances and regulations. Refer to section 5.5 Decommissioning and Disposal for
additional information.
CAUTION: Electromagnetic interference is possible between impedance (Z) catheters and implanted
devices such as pacemakers and internal defibrillators. Monitoring of all implanted
devices is advised.
CAUTION: Inspect the catheter for damage such as bent or broken pins. Also, verify the integrity of
the Catheter between the tubing and each sensor. Do not connect the Catheter to the
equipment if there is visible damage. Refer to the Catheter manufacturer’s cautions and
warnings found in the Catheter manufacturer’s user guide.
CAUTION: In order to minimize the risk of nosebleed, use adequate lubrication with a water soluble
lubricant for catheter intubation.
CAUTION: To clean the monitor, use a cloth that has been slightly dampened in a solution of warm
water and mild detergent. Avoid solvents which may damage the product cases. Follow
hospital protocol. Do not apply liquid directly to monitor.
CAUTION: Only use Diversatek Healthcare approved accessories with the inSIGHT System.
Damage to the system, the accessory, and/or patient injury may occur.
CAUTION: Do not use Diversatek Healthcare accessories with other non-Diversatek Healthcare
equipment. Damage to the system, the accessory, and/or patient injury may occur.
CAUTION: Do not use the inSIGHT System in association with an MRI machine. The inSIGHT
System contains sensitive electronics not designed to operate in the extensive magnetic
fields of an MRI machine.
CAUTION: Do not use the inSIGHT System or other signal conditioning devices in emergency
situations or for patient treatment or monitoring. The system is designed for diagnostic
use only in non-emergency situations.
CAUTION: Do not use the inSIGHT System in an oxygen rich environment.
CAUTION: Any serious incidents that occur in relation to the inSIGHT System should be reported to
Diversatek and the Competent Authority.
CAUTION: Do not connect any multiple socket-outlet or extension cord to the output side of the
isolation transformer.
CAUTION: Do not connect any devices not associated with the inSIGHT Ultima System to the
output side of the isolation transformer. The isolation transformer should only be used
with the inSIGHT Ultima System components.

inSIGHT Ultima®System with ZVU®
Installation and User’s Guide
H12R-0195 Rev. 7, Edited 22 September 2022, ECO 220-012 4
NOTICE: Use of non-Diversatek Healthcare approved USB devices may cause unpredictable
intermittent device operation.
NOTICE: Use of an uninterruptible power system is suggested if the quality of power is questionable.
NOTICE: Do not store the inSIGHT System or signal conditioning devices in extreme temperatures.
The inSIGHT System and signal conditioning devices are best stored between 33° and
158°F (1° to 70°C).
NOTICE: Do not drop the inSIGHT System or the signal conditioning devices.
NOTICE: Do not run other software, update software or the operating system, or add/remove
peripherals during data acquisition.
NOTICE: Microsoft Windows does not allow the Hibernate, System Standby, or Hard Disks Power-
Off features to be deactivated through software, so ZVU®cannot deactivate these features.
Turning on any of these features may cause the termination of acquired data while the
items are shut down. Data loss may occur. Use caution when turning on these features.

inSIGHT Ultima®System with ZVU®
Installation and User’s Guide
H12R-0195 Rev. 7, Edited 22 September 2022, ECO 220-012 5
1.3 Product Description
1.3.1 Indications of Use
The inSIGHT Ultima Gastrointestinal Motility System is intended for use by gastroenterologists, surgeons, and
medically trained personnel as an aid in documenting and diagnosing digestive motility disorders. It may be used
for esophageal and anorectal studies. The system includes analysis software, but requires a skilled interpretation by
a physician to make a diagnosis.
1.3.2 Contraindications
Esophageal manometry is contraindicated in the following situations:
•Suspicious or known pharyngeal or upper esophageal obstruction (e.g., tumors)
•Patients with severe clotting disorders
•Patients with known esophageal problems such as deep ulcers, varices, Zenker's diverticula, and strictures
Anorectal manometry is contraindicated in the following situations:
•Patients with known anal obstructions.
Small bowel manometry is contraindicated in the following situations:
•Those associated with esophagogastroduodenoscopy (EGD).
•Massively dilated small bowel is a relative contraindication due to risk of perforation.
•Known multiple jejunal diverticulosis.
1.3.3 Features
The inSIGHT Ultima System was designed with the end user in mind. The inSIGHT Ultima System offers the
following features:
•Specialized modules focused on specific clinical procedures.
•Guided Protocols to guide the operator step by step through the procedure.
•On-screen Help buttons accessible by users at any time during a procedure if detailed instructions are needed.
•Compatible with a flat panel LCD display to save space and facilitate transportation.
•Works with a touch screen display that may eliminate the need for a keyboard and mouse during data
acquisition.
•A flexible system that supports various configurations to meet the clinician’s requirements.
1.3.4 Biocompatibility
The inSIGHT Ultima System components utilize common materials with no known biocompatibility issues.
However, the following cautions should be observed:
CAUTION: Some catheters have applied parts made with 316L stainless steel. This
type of stainless steel, although medical grade, contains 10-14% nickel
which may pose risks for people with certain allergies to nickel.

inSIGHT Ultima®System with ZVU®
Installation and User’s Guide
H12R-0195 Rev. 7, Edited 22 September 2022, ECO 220-012 6
2 System Components
The following sections describe the various components of the inSIGHT Ultima System.
2.1 User Manuals
All of the user manuals for the inSIGHT Ultima System are provided in electronic versions that are installed along
with the ZVU Software suite. The following table lists the various manuals provided. Please refer to these manuals
for additional information.
Manual Part Number
Title
H12R-0195
inSIGHT Ultima System Installation and User’s Guide
2.2 Main System Components
The inSIGHT Ultima Motility System consists of the following main components. Optional signal conditioning
units are available. Refer to the manuals accompanying those units for additional information.
2.3 Configurations
The inSIGHT System is available in two configurations: Cart and Desktop. The active medical components are the
same for both the cart and desktop configurations. The rolling cart is offered for those customers who require
additional mobility.
inSIGHT Ultima Central Unit:
Provides patient isolation for safety; translates data format and
transfers data to host computer.
Host Computer:
Provides computer processing capabilities to acquire, store, and
analyze recorded patient data.
Touch Screen Monitor:
The display shows the waveform data that is being acquired from the
patient.
Catheters and Transducers:
Patient applied parts to collect biomedical data and convert it into a
format that can be displayed and analyzed using a computer.
Isolation Transformer:
Safety device required for use with system. Provides electrical
isolation of the system and minimizes potential leakage current.
Printer:
Optional accessory for producing hard copy reports.

inSIGHT Ultima®System with ZVU®
Installation and User’s Guide
H12R-0195 Rev. 7, Edited 22 September 2022, ECO 220-012 7
2.3.1 Cart Configuration
The inSIGHT Ultima Motility System is offered with an optional rolling cart.The following diagram shows the
locations of the main components.
Printer
PC
inSIGHT Ultima
Central Unit
Keyboard
and Mouse
Tray
Water
Calibration
Tube
Touch
Screen
Monitor
Storage
Compartment
Height
Adjustment
Pedal
AC Main
Power Supply
Connection
Catheter
Cable Holder
Isolation
Transformer
(under cover)
AC Main
Power
Supply
Switch
Air
Calibration
Tube
inSIGHT
Ultima
Central Unit

inSIGHT Ultima®System with ZVU®
Installation and User’s Guide
H12R-0195 Rev. 7, Edited 22 September 2022, ECO 220-012 8
2.3.2 Desktop Configuration
The inSIGHT Ultima Motility System is offered in a desktop configuration. The following diagram shows the main
components.
PC
Touch Screen Monitor
Isolation
Transformer
inSIGHT
Ultima Central
Unit
Items not shown:
•Water Calibration Tube
•Air Calibration Tube
•Hand-held Pressure Gauge
•Printer

inSIGHT Ultima®System with ZVU®
Installation and User’s Guide
H12R-0195 Rev. 7, Edited 22 September 2022, ECO 220-012 9
2.4 Electrical Configuration
CAUTION: A suitable medical grade isolation transformer is
required for this system.
Figure 1: Electrical Configuration
Connect the system components together according to the following manner (refer to Figure 1 above):
•Connect all AC power cords to the isolation transformer.
2.5 Isolation Transformer Setup (for Desktop Configuration)
An isolation transformer is a critical safety device that helps to isolate the patient from electrical hazards. The
following precautions must be followed for the isolation transformer to provide the best protection possible.
CAUTION: The inSIGHT Ultima System must receive AC Main power supply from a medical
grade isolation transformer. The supplied isolating transformer is specified as a
part of the Medical Electrical System.
CAUTION: Connect all devices of the inSIGHT Ultima System to the output side of the
isolation transformer as described in section 2.4 above.
CAUTION: Do not connect any devices not associated with the inSIGHT Ultima System to the
output side of the isolation transformer. The isolation transformer should only be
used with the inSIGHT Ultima System components.
CAUTION: Do not connect any multiple socket-outlet or extension cord to the output side of
the isolation transformer.
NOTE: See the appendix for the isolation transformer specifications.
Isolation Transformer
AC Main Power Supply
LCD Monitor
Host Computer
inSIGHT Ultima

inSIGHT Ultima®System with ZVU®
Installation and User’s Guide
H12R-0195 Rev. 7, Edited 22 September 2022, ECO 220-012 10
2.5.1 Voltage Settings (for Desktop Configuration)
The Input and Output voltage settings must be configured before connecting the isolation transformer into the AC
Main power supply. The Input voltage selector is set through a four-position key that is located within the fuse
holder of the power entry module (see below). When setting the voltage selector, the desired voltage will be visible
in the window. The Output voltage selector is set through a two-position switch on the bottom of the unit (see
below). Refer to the following table for the proper Input and Output voltage settings for your region. If your input
voltage for your area is not listed below, please contact Technical Support for assistance.
Region
Input
Output
North America (120 V~)
120 V~
115 V~
Europe (230-240 V~)
240 V~
230 V~
Japan (100 V~)
100 V~
115 V~
Other 220 V~
220 V~
230 V~
Input Voltage
Selector
Output
Voltage
Selector

inSIGHT Ultima®System with ZVU®
Installation and User’s Guide
H12R-0195 Rev. 7, Edited 22 September 2022, ECO 220-012 11
2.6 Connecting the System to a Data Network
The inSIGHT Ultima System does not need to be connected to a data network for it to function properly and achieve
its intended use. Attachment to a network provides for convenient sharing of data files, back-up of data, and
printing to network printers. There are no known hazardous situations resulting from a failure of the network
coupling.
The IT data network port utilized by the inSIGHT Ultima System conforms to the conventional Ethernet standard
IEEE 802.3. There are no required characteristics or configuration of the IT network.
If the inSIGHT Ultima System is connected to a data network, please be aware of the following:
CAUTION: Connection of the inSIGHT Ultima System to a network/data
coupling that includes other equipment could result in previously
unidentified risks to patients, operators or third parties. All risks
should be identified, analyzed, evaluated and controlled. Subsequent
changes to the network/data coupling could introduce new risk and
require additional analysis such as unauthorized access. Changes to
the network/data coupling include:
•Changes in network/data coupling configuration
•Connection of additional items to the network/data coupling
•Disconnecting items from the network/data coupling
•Update of equipment connected to the network/data coupling
•Upgrade of equipment connected to the network/data coupling
Please refer to the current revision of IEC 60601-1 for the requirements applicable to Medical Electrical (ME)
Systems.

inSIGHT Ultima®System with ZVU®
Installation and User’s Guide
H12R-0195 Rev. 7, Edited 22 September 2022, ECO 220-012 12
3 Controls and Connections
3.1 inSIGHT Ultima Central Unit
The inSIGHT Ultima Central Unit is the main component of the inSIGHT system. It provides data buffering to the
inSIGHT Acquisition Software running on the PC.
Accessory Port 2
ISO Power Indication LED
and Port 1-5 Status LEDs
Power Switch and
Power Indication LED
Accessory Port 3
Accessory Port 4
Port 1 –High
Resolution Catheters
Air Outlet
Air Inlet
DC Power Input
USB
Port 5
(unused)

inSIGHT Ultima®System with ZVU®
Installation and User’s Guide
H12R-0195 Rev. 7, Edited 22 September 2022, ECO 220-012 13
3.1.1 Ports, Switches and Indicators
•USB - Connection port for the USB cord attaching the system to the PC.
•Power Switch –This controls the DC power supplied by the external medical grade power supply brick.
NOTE: This switch controls the power supplied to the
inSIGHT Ultima Central Unit and all attached signal
conditioning units.
•DC Power Input –This is the DC power input receptacle.
CAUTION: To avoid the risk of electric shock, this equipment must only be
connected to an AC Main power supply with protective earth
ground.
CAUTION: The inSIGHT System must receive AC Main power supply from a
medical grade isolation transformer. The supplied isolating
transformer is specified as a part of the Medical Electrical System.
•Air Inlet and Outlet Ports –Air supply and pressure sensing ports for the automated calibration tube
feature.
•Port 1 –A patient isolated connection port for attaching to the High Resolution Catheters.
•Ports 2-4 –Non-patient isolated Accessory Ports for attaching external device adapters. Patient
connected external device adapters have their own built-in patient isolation.
•Port 5 –Unused. Reserved for future expansion.
•Power Indication LED –A green LED that is illuminated when the Power Switch is in the ON position
and the DC input is measured to be at the appropriate voltage levels.
•ISO Power Indication LED –A green LED that is illuminated when the isolated power of the internal
High Resolution Catheter Adapter board is determined to be at the appropriate levels for
operation.
•Port 1 Indication LED –A blue LED that is illuminated when the High Resolution Catheter is attached
to Port 1 and communicating properly.
•Port 2-5 Indication LEDs –Blue LEDs that are illuminated when an external device adapter module is
plugged in and communicating properly. These LEDs will blink if the InSIGHT Ultima Central
Unit detects the device adapter module was plugged in but communication was not established.
If blinking, try re-plugging in the device or use a different port. Contact Technical Support for
assistance.

inSIGHT Ultima®System with ZVU®
Installation and User’s Guide
H12R-0195 Rev. 7, Edited 22 September 2022, ECO 220-012 14
3.1.2 Automated Air Calibration
The ZVU Software is able to utilize the automated air calibration feature of the inSIGHT Ultima System. Inside the
inSIGHT Ultima is a small air pump that ZVU turns on to pressurize the air calibration tube. ZVU then monitors the
inSIGHT Ultima’s calibration sensor to detect the calibration points. The releasing of the air is accomplished
through two tiny vent holes, one located in each of the two air lines.
To use the automated calibration feature of the inSIGHT Ultima two air lines must be installed between the
inSIGHT Ultima and the air calibration tube cap.
a) Disconnect the sphygmomanometer from the air calibration tube. To release
the fitting, press down on the metal tab of the port on the calibration tube.
b) Connect the straight fitting ends of the two air lines to the two ports on
the inSIGHT Ultima. The air lines are identical and can be plugged
into either port. The fittings are fully seated when the metal tab on the
port clicks up.
c) Connect the elbow fitting of the two tubes to the two ports on the air
calibration tube. The air lines are identical and can be plugged into either
port. Twist the fittings so the barbed end of the fitting points upward and
the tubing is not kinked.
To perform a manual calibration, disconnect both connectors from the air calibration tube only. Leave the air lines
connected to the inSIGHT Ultima. Connect the sphygmomanometer to either of the connector ports on the air
calibration tube.
Table of contents