Summary of Contents for Diversatek Healthcare inSIGHT Ultima
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Central Unit for ® Manometry Installation and User’s Guide Diversatek Healthcare Technical Research & Training Center 9150 Commerce Center Circle, Suite 500 Highlands Ranch, CO 80129 USA P 800.558.6408 or 303.470.7020 technicalsupport@diversatekhc.com clinicalsupport@diversatekhc.com clinicaleducation@diversatekhc.com DiversatekHealthcare.com Part Number: H12R-0195 Rev.7...
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® ® inSIGHT Ultima System with Z Installation and User’s Guide Notes, Notices, and Cautions in User’s Guide A NOTE indicates important information that helps you make better use of NOTE: your system. A NOTICE indicates either potential damage to hardware or loss of data and NOTICE: tells you how to avoid the problem.
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® ® inSIGHT Ultima System with Z Installation and User’s Guide inSIGHT Central Unit Classifications This symbol indicates that the patient applied part is Type BF, (floating from Type BF Applied Part: electrical ground) which offers a specific level of safety.
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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.
1 Introduction 1.1 How to Use This Guide This guide is designed to help you install the inSIGHT Ultima system and the Z 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.
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.
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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.
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Ultima System with Z Installation and User’s Guide 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.
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.
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 Z Software suite. The following table lists the various manuals provided. Please refer to these manuals for additional information.
® inSIGHT Ultima System with Z Installation and User’s Guide 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. inSIGHT Ultima Central Unit Touch...
® ® inSIGHT Ultima System with Z Installation and User’s Guide 2.3.2 Desktop Configuration The inSIGHT Ultima Motility System is offered in a desktop configuration. The following diagram shows the main components. Touch Screen Monitor Isolation inSIGHT Transformer Ultima Central...
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.
® ® inSIGHT Ultima System with Z Installation and User’s Guide 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).
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.
Installation and User’s Guide 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. Power Switch and...
• 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.
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.
Installation and User’s Guide 3.2 Signal Conditioning Units The inSIGHT Ultima Motility System is designed to be very flexible. Signal conditioning modules have been developed to allow for processing a variety of signals related to the GI tract. These include pressure and impedance.
Installation and User’s Guide 3.3 System Cart The inSIGHT Ultima System is available as a rolling cart system. This cart is designed with ergonomic features to make the use of the system more comfortable, efficient and effective. These include an adjustable working height and adjustable monitor mount.
® ® inSIGHT Ultima System with Z Installation and User’s Guide 3.3.2 Monitor Adjustments The touchscreen monitor mount can be swiveled left and right as well as tilted up and down to provide a comfortable viewing arrangement. The monitor can be easily swiveled left and right by grabbing the side of the monitor and pushing or pulling to the desired location.
® ® inSIGHT Ultima System with Z Installation and User’s Guide 3.3.3 Casters and Caster Locks The system cart utilizes five inch diameter casters with hard rubber treads. These provide for smooth travel over hard flooring as well as carpeting. The large diameter wheels also provide good stability when traveling over small obstructions like cords and elevator thresholds.
® ® inSIGHT Ultima System with Z Installation and User’s Guide 3.3.4 Moving the Cart When moving the cart long distances care must be taken to prepare the cart for movement. The following items are suggested: • Place the mouse into the mouse holder cup behind the keyboard and slide the mouse tray in.
Installation and User’s Guide 3.4 Basic Operation of the System This section is intended to provide a brief introduction of the steps necessary to safely bring the inSIGHT Ultima System to an operational mode and how to terminate operation when finished.
Installation and User’s Guide 4 Software For inSIGHT Ultima Systems with a PC, all required software is pre-installed. However, in special situations, it may be necessary to install the latest update or other special software. If such a situation arises, first consult this section for guidance, and then if in doubt, please contact Technical Support.
Section 4.2 Software Installation Instructions. 4.5 Security and Authentication The inSIGHT Ultima System software utilizes patient identifying information. In some countries, access to this kind of information must be restricted. The use of Windows Security and Authentication to limit access to the software and patient data is recommended.
5.1.1 inSIGHT Ultima, Cart, and Accessories Clean the outside of the inSIGHT Ultima System and all accessories as needed with disinfectant solutions or an approved hospital grade wipe defined by the appropriate rules of the using institution. Do not immerse these items in water or any other solution as this may cause damage to the sensitive electronics inside.
® ® inSIGHT Ultima System with Z Installation and User’s Guide The probe case insert can be cleaned as needed with an alcohol wipe before placing the reprocessed probe in the case for storage. 5.2 Air Calibration Tube Seals The air calibration tube utilizes several o-rings and gaskets to obtain an air tight seal. Over time, these parts may dry out and need to be replaced.
Installation and User’s Guide 5.3 Preventative Maintenance The inSIGHT Ultima System should be periodically examined to ensure the device is in working order. This will help eliminate problems while a study is being performed. In addition to periodic cleaning mentioned above, the following should be done on a regular basis. Contact Technical Support for replacement parts.
® ® inSIGHT Ultima System with Z Installation and User’s Guide 6 Appendix 6.1 Technical Support Technical Support can be reached by mail, telephone, fax, or e-mail. Please see the listings below for complete contact information. We strive to provide customers with the highest quality, state-of the-art instrumentation, backed by service, support and training.
Ultima System with Z Installation and User’s Guide 6.2 Declaration of Conformity The inSIGHT Ultima System complies with the following standards Safety • IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007) + AM1:2012 (or IEC 60601-1:2012 reprint) •...
Guidance and manufacturer’s declaration – electromagnetic emissions The inSIGHT Ultima System is intended for use in the electromagnetic environment specified below. The customer or the user of the inSIGHT Ultima System should assure that it is used in such an environment.
Guidance and manufacturer’s declaration – electromagnetic immunity The inSIGHT Ultima System is intended for use in the electromagnetic environment specified below. The customer or the user of the inSIGHT Ultima System should assure that it is used in such an environment.
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Guidance and manufacturer’s declaration – electromagnetic immunity The inSIGHT Ultima System is intended for use in the electromagnetic environment specified below. The customer or the user of the inSIGHT Ultima System should assure that it is used in such an environment.
Recommended separation distances between portable and mobile RF communications equipment the inSIGHT Ultima System The inSIGHT Ultima System is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the inSIGHT Ultima...
Up to 48 Channels, with up to 48 displayed simultaneously. Channel Types: Provided through separate signal conditioning units: Pressure and Impedance. Analog to Digital Conversion: Integral to inSIGHT Ultima, 16 bit. Catheter Type: Disposable or Reusable (Contact Technical Support for suitability listing). Operating Environment: Temperature: 10°C - 40°C (50°F-104°F)
® ® inSIGHT Ultima System with Z Installation and User’s Guide 6.4.3 Cart Part Number: CART5R Dimensions: Height: 66 in (167.6 cm) Width: 19 in (48.3 cm) Depth: 24 in (61 cm) Weight: 120 lb (54.4 Kg) AC Power Input:...
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