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Diversatek Healthcare PriZm Installation And User Manual

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Installation and User's Guide
2460
Part Number: H20-0195 Rev B
Central Unit for Zvu
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
®
Manometry

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  • Page 1 ® Central Unit for Zvu 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 2460 clinicaleducation@diversatekhc.com DiversatekHealthcare.com Part Number: H20-0195 Rev B...
  • Page 2 ® PriZm System 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.
  • Page 3 ® PriZm System Installation and User’s Guide PriZm 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. Power Source Class I Equipment - Requires protective earth grounding.
  • Page 4 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.

  • Page 5: Table Of Contents

    PGRADES ........................ 22 ECURITY AND UTHENTICATION Cleaning and Preventative Maintenance ......................23 ..........................23 LEANING ROCEDURE 5.1.1 PriZm, Cart, and Accessories ......................23 5.1.2 Calibration Tubes ..........................23 5.1.3 Probe Case Cleaning ........................... 23 ........................24 ALIBRATION EALS ........................25...
  • Page 6 Electromagnetic Emissions ........................28 6.3.2 Electromagnetic Immunity ........................29 6.3.3 Recommended Separation Distances ....................31 ............................32 PECIFICATIONS 6.4.1 PriZm Central Unit ..........................32 6.4.2 Isolation Transformer .......................... 32 6.4.3 Cart ..............................32 H20-0195 Rev B, Edited 12/10/2020, ECO 220-034...

  • Page 7: Introduction

    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 PriZm System and Zvu Software refer to the help screens incorporated into the software.

  • Page 8: Caution: Safety Instructions

    The PriZm 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 PriZm 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.
  • Page 9 Damage to the system, the accessory, and/or patient injury may occur. CAUTION: Do not use the PriZm System in association with an MRI machine. The PriZm System contains sensitive electronics not designed to operate in the extensive magnetic fields of an MRI machine.
  • Page 10 ® PriZm System Installation and User’s Guide 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.

  • Page 11: Product Description

    Massively dilated small bowel is a relative contraindication due to risk of perforation. • Known multiple jejunal diverticulosis. 1.3.3 Features The PriZm System was designed with the end user in mind. The PriZm System offers the following features: • Specialized modules focused on specific clinical procedures. •...

  • Page 12: System Components

    System. 2.1 User Manuals All of the user manuals for the PriZm System are provided in electronic versions that are installed along with the ® Software suite. The following table lists the various manuals provided. Please refer to these manuals for additional information.

  • Page 13: Cart Configuration

    ® PriZm System Installation and User’s Guide 2.3.1 Cart Configuration ® The PriZm System is offered with an optional rolling cart. The following diagram shows the locations of the main components. PriZm Central Unit Touch Screen Monitor Storage Water Catheter...

  • Page 14: Desktop Configuration

    ® PriZm System Installation and User’s Guide 2.3.2 Desktop Configuration ® The PriZm System is offered in a desktop configuration. The following diagram shows the main components. Touch Screen Monitor Isolation PriZm Transformer Central Unit Items not shown: • Water Calibration Tube •...

  • Page 15: Electrical Configuration

    The supplied isolating transformer is specified as a part of the Medical Electrical System. CAUTION: Connect all devices of the PriZm 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 PriZm System to the output side of the isolation transformer.

  • Page 16: Voltage Settings (For Desktop Configuration)

    ® PriZm System 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 Mains power source. 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).

  • Page 17: Connecting The System To A Data Network

    There are no known hazardous situations resulting from a failure of the network coupling. The IT data network port utilized by the PriZm System conforms to the conventional Ethernet standard IEEE 802.3. There are no required characteristics or configuration of the IT network.

  • Page 18: Controls And Connections

    3 Controls and Connections 3.1 PriZm Central Unit ® The PriZm Central Unit is the main component of the PriZm system. It provides data buffering to the acquisition software running on the PC. Power Switch and Power Indication LED ISO Power Indication LED...

  • Page 19: Ports, Switches And Indicators

    • Port 2-4 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 PriZm 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.

  • Page 20: Automated Air Calibration

    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 PriZm two air lines must be installed between the PriZm and the air calibration tube cap.

  • Page 21: Signal Conditioning Units

    GI tract. These include pressure and impedance. 3.2.1 High Resolution Catheter Adapter Integrated into the PriZm Central Unit is the High Resolution Catheter Adapter. This adapter provides pressure and impedance signal conditioning for the High Resolution catheters as well as electrical patient isolation.

  • Page 22: System Cart

    3.3 System Cart ® The PriZm 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.

  • Page 23: Monitor Adjustments

    ® PriZm System 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.

  • Page 24: Casters And Caster Locks

    ® PriZm System 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.

  • Page 25: Moving The Cart

    ® PriZm System 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.

  • Page 26: Basic Operation Of The System

    3.4.1 Plugging in the System The PriZm System utilizes a hospital grade AC Mains cord with the correct plug for your power source. The following notes about safety should be kept in mind when arranging the PriZm System for use.

  • Page 27: Software

    NOTE: Zvu utilizes workflows that associate a study protocol with the required acquisition hardware. Be sure to create new workflows and specify the PriZm as the acquisition device. Workflows for other acquisition devices will generate an error when they are used with the PriZm because they expect different hardware to be attached.

  • Page 28: Software Activation

    Installation and User’s Guide 4.3 Software Activation ® Diversatek Healthcare is required by regulatory agencies to track the installation of Zvu Software at each customer site. To comply with regulations, Zvu requires that each installation on each computer be activated. Basic site and computer information for each installation of Zvu Software will need to be provided.

  • Page 29: Cleaning And Preventative Maintenance

    5.1.1 PriZm, Cart, and Accessories ® Clean the outside of the PriZm 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.

  • Page 30: Air Calibration Tube Seals

    ® PriZm System 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.

  • Page 31: Preventative Maintenance

    Inspect reusable catheters for damage to the connector or Catheter body. Refer to the Catheter manual for cleaning and disinfecting information. 5.4 Service There are no serviceable components in the PriZm System. If necessary, the device should be returned to Technical Support for repair. 5.5 Decommissioning and Disposal The PriZm System does not require decommissioning to remove it from service.

  • Page 32: Appendix

    ® PriZm System 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.

  • Page 33: Declaration Of Conformity

    ® PriZm System Installation and User’s Guide 6.2 Declaration of Conformity ® The PriZm 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) •...

  • Page 34: Emc Information

    Guidance and manufacturer’s declaration – electromagnetic emissions ® The PriZm System is intended for use in the electromagnetic environment specified below. The customer or the user of the PriZm System should ensure that it is used in such an environment. Emissions Test Compliance...

  • Page 35: Electromagnetic Immunity

    ® The PriZm System is intended for use in the electromagnetic environment specified below. The customer or the user of the PriZm System should ensure that it is used in such an environment. IEC 60601 Electromagnetic environment - Immunity test...
  • Page 36 Guidance and manufacturer’s declaration – electromagnetic immunity The PriZm ® System is intended for use in the electromagnetic environment specified below. The customer or the user of the PriZm System should ensure that it is used in such an environment. IEC 60601 Immunity test Compliance level...

  • Page 37: Recommended Separation Distances

    The PriZm System is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the PriZm System can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the PriZm System as recommended below, according to the maximum output power of the communications equipment.

  • Page 38: Specifications

    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 PriZm, 16 bit. Catheter Type: Disposable or Reusable (Contact Technical Support for suitability listing). Operating Environment: Temperature: 10°C - 40°C (50°F-104°F)

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