Viewstation OR Operating Instructions Rev C Sept 2010

Operating Instructions

Datascope

Viewstation

™

Masimo SET® is a U.S. registered trademark of Masimo Corp. Nellcor® is U.S. registered trademark of Tyco International Ltd. Panorama™ is a U.S. trademark of Mindray DS USA Inc. Spectrum OR™ is a U.S. trademark of Mindray DS USA Inc. Viewstation OR™ is a U.S. trademark of Mindray DS USA Inc.

Copyright © Mindray DS USA Inc., 2007. All rights reserved. Contents of this publication may not be reproduced in any form without permission of Mindray DS USA Inc. Due to the continuous evolution of our products, all capabilities documented in this manual may not be currently available.

Viewstation OR™ Operating Instructions

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Table of Contents

Foreword ... v Warnings, Precautions and Notes... v Indications for Use ... viii Unpacking Information ... viii Technical Support ... viii Symbols and Descriptions ... ix

System Overview ... 1 - 1 The Viewstation OR... 1 - 2 Basic Configuration... 1 - 2 Supported Device ... 1 - 4 Spectrum OR™ ... 1 - 4

Viewstation OR Main Screen ... 2 - 1 The Main Screen ... 2 - 1 Waveform Parameter Tiles... 2 - 2 Waveform Area ... 2 - 3 Waveform Digital Area ... 2 - 4 Digital Parameter Tiles... 2 - 5 Menu Bar ... 2 - 7 System Status/Demographics Area ... 2 - 8 Date and Time ... 2 - 8 Display States ... 2 - 9

Patient Setup Functions ... 3 - 1 Display Tab... 3 - 2 Accessing the Display Tab ... 3 - 2 Components of the Display Tab ... 3 - 2 Configuring the Waveform and Digital Parameter Areas ... 3 - 4 Saving a Display Configuration... 3 - 6 Loading a New Display Configuration ... 3 - 7 Removing a Display Configuration ... 3 - 7 Editing a Display Name ... 3 - 7 Sidebar Buttons ... 3 - 9 Troubleshooting... 3 - 9 Wave Gain Tab (Patient) ... 3 - 10 Accessing the Wave Gain Tab (Patient)... 3 - 10 Configuring Wave Gain Settings... 3 - 10 Sidebar Buttons ... 3 - 11 Troubleshooting... 3 - 11

System Setup Functions... 4 - 1 Parameter Color Tab ... 4 - 2 Accessing the Parameter Color Tab ... 4 - 2 Selecting a Color for Parameter Data ... 4 - 2 Sidebar Button - Normal Screen ... 4 - 3 Troubleshooting... 4 - 3 Equipment Setup Tab... 4 - 3 Accessing the Equipment Setup Tab ... 4 - 4 Connecting Equipment ... 4 - 4 Sidebar Button - Normal Screen ... 4 - 4 Troubleshooting... 4 - 4 Wave Gain Tab (System)... 4 - 5 Accessing the Wave Gain Tab... 4 - 5 Changing the System Default Wave Gain Settings ... 4 - 5 Sidebar Button - Normal Screen ... 4 - 5

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Table of Contents

Touch Screen Tab ... 4 - 6 Accessing the Touch Screen Tab... 4 - 6 Turning the Touch Screen On and Off ... 4 - 6 Recalibrating the Touch Screen ... 4 - 7 Sidebar Button - Normal Screen ... 4 - 8 Troubleshooting... 4 - 8

User Maintenance ... 5 - 1 Care and Cleaning of the Touch Screen ... 5 - 2

Parameter Specifications... 6 - 1 Heart Rate (HR)... 6 - 2 Respiration (Resp) ... 6 - 2 NIBP ... 6 - 3 SpO2 ... 6 - 4 IBP ... 6 - 4 CO2... 6 - 5 Temperature (T1, T2, and T Blood) ... 6 - 5 Cardiac Output ... 6 - 6 Cardiac Index ... 6 - 6 Pulmonary Artery Wedge Pressure (PAWP) ... 6 - 6 Invalid Data Display... 6 - 7

Performance Specifications ... 7 - 1 ECG... 7 - 2 ECG Derived Heart Rate Meter ... 7 - 2 ECG Respiration... 7 - 2 NIBP ... 7 - 3 Systolic Pressure Measurement ... 7 - 3 Diastolic Pressure Measurement... 7 - 3 Pulse Rate ... 7 - 3 IBP ... 7 - 3 IBP Heart Rate Meter... 7 - 3 Temperature ... 7 - 4 SpO2 ... 7 - 4 CO2... 7 - 4 Viewstation OR Computer ... 7 - 5 Real Time Clock ... 7 - 5 Power Supply... 7 - 5 Operating Temperature ... 7 - 5 Operating Humidity ... 7 - 5 Operating Altitude... 7 - 5 Storage Temperature... 7 - 6 Storage Humidity... 7 - 6 Storage Altitude ... 7 - 6 Safety Standards ... 7 - 6 Electromagnetic Compatibility ... 7 - 7 Physical Characteristics ... 7 - 10 I/O Control Devices... 7 - 11 Displays... 7 - 11 Mindray DS Supplied ELO-Compatible Touch Screen Display... 7 - 11 Customer Supplied Compatible Displays ... 7 - 11 Warranty... 7 - 12 Phone Numbers and How To Get Assistance... 7 - 14 Mindray DS’s Responsibility ... 7 - 14

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Table of Contents

Glossary... 8 - 1 Terms, Acronyms, and Abbreviations ... 8 - 2

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Viewstation OR™ Operating Instructions

Foreword

Introduction

Foreword The Viewstation OR Operating Instructions are intended to provide the information required to operate the Viewstation OR. For additional information and technical assistance, please contact a Mindray DS Patient Monitoring Representative. A general understanding of the features and functions of the Viewstation OR and its components (shown in FIGURE 1-1) is a prerequisite for the proper use of this equipment. Therefore, do not operate this equipment before reading these instructions thoroughly, including all appropriate warnings and cautions. CAUTION:

US Federal law restricts the sale of this device to, by or on the order of a physician.

NOTE:

Figures in this manual are provided for reference purposes only. Screens will likely differ based on the monitoring device configuration and selected parameter configurations of the Viewstation OR.

Warnings, Precautions and Notes Please read and adhere to all of the warnings and precautions listed throughout this manual. A WARNING is provided to alert the user to potentially serious outcomes (death, injury or serious adverse events) to the patient or the user. A CAUTION is provided to alert the user that special care should be taken for the safe and effective use of the device. They will include actions to be taken to avoid effects on patients or users that will not be potentially life threatening or result in serious injury, but about which the user should be aware. A NOTE is provided when additional general information is available.

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Introduction

Warnings, Precautions and Notes

Warnings WARNING: Only qualified and trained personnel or Mindray DS Service personnel should attempt to service Mindray DS equipment. Service is defined as any activity requiring the cover to be removed for internal adjustments, parts replacements, repairs or software upgrades of any kind to insure compatibility. WARNING: To insure compatibility with the operating system and applications software, use only Mindray DS USA Inc. supplied and/or approved components to repair any part of the Viewstation OR. Use of unauthorized software, devices, accessories, or cables other than those approved by Mindray DS may render the application unsuitable for medical patient monitoring. It may also result in increased electromagnetic emissions or decreased Immunity of the system. WARNING: Route cables neatly. Ensure cables are not in the way of patient or hospital personnel. WARNING: All of the equipment on the Viewstation OR network must utilize the hospital emergency power system. Failure to do so will result in loss of monitoring during extended periods of power failure. WARNING: Do not put MPSO (Multiple Portable Socket Outlets, i.e., multiple outlet extension cords) used with the Viewstation OR equipment on the floor. Connect only approved accessories and components to the same MPSO as the Viewstation OR equipment. Do not overload MPSOs. Use only MPSOs that comply with the requirements of IEC 60601-1-1. WARNING: PACEMAKER PATIENTS - Indication of the heart-rate may be adversely affected by cardiac pacemaker pulses or by cardiac arrhythmias. Keep pacemaker patients under close surveillance. Refer to "ECG" on page 7-2 for disclosure of the pacer rejection capability. WARNING: PACEMAKER PATIENTS - Rate meters may continue to count the pacemaker rate during occurrences of cardiac arrest or some arrhythmias. Do not rely entirely upon rate meter alarms. Keep pacemaker patients under close surveillance. WARNING: When connecting any Spectrum OR monitor, verify its location and associated device ID and bed number.

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Warnings, Precautions and Notes

Introduction

Cautions CAUTION:

For proper operation do not obstruct the fan air holes.

CAUTION:

For proper operation use only hospital grade power cords.

CAUTION:

For proper operation, do not use the Viewstation OR equipment with a frayed or damaged power cord.

CAUTION:

For proper operation never place fluids on top of this equipment. In case of accidental spillage, wipe clean immediately and have the system serviced to ensure no hazard exists.

CAUTION:

For proper monitoring of patient information, do not block the operators' clear view of the Viewstation OR data display(s).

CAUTION:

Changes or modifications not expressly approved by Mindray DS USA Inc. could void the user's warranty.

CAUTION:

To avoid potential system issues, deactivate the touch screen before cleaning.

CAUTION:

DO NOT spray glass cleaner directly on a display as it could possibly leak inside a non-sealed unit and cause damage.

CAUTION:

Some pacemakers may contain a respiratory sensor that may produce artifact on an ECG waveform.

CAUTION:

The Viewstation OR must be installed outside the patient’s vicinity.

CAUTION:

The Viewstation OR CPU should not be used within 25 cm of the point where leakage or discharge of a flammable anesthetic mixture with oxygen or nitrous oxide may occur.

CAUTION:

Do not use the Viewstation OR if the case has been dropped or damaged.

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Introduction

Indications for Use

Indications for Use The indications for use for the Viewstation OR include viewing real time patient clinical data. The clinical data displayed by the Viewstation OR is obtained from a Spectrum OR™ patient monitor and includes: ECG waveforms, Invasive and Non-Invasive Blood Pressures, Blood Oxygenation (SpO2), Heart Rate, Respiration Rate, PVC/min, Temperature, CO2 inspired and end tidal, CO/CI, CCO/CCI, SvO2 and PAWP for a patient. The Viewstation OR is intended for use in a fixed, non-portable, permanent location as a secondary independent remote display in the Operating Room department. The Viewstation OR does not display or annunciate physiological or technical alarms originating from the Spectrum OR monitor. The Viewstation OR is not intended to be directly connected to the patient at any time or installed within a six foot radius of the patient.

Unpacking Information The Viewstation OR must be installed by a certified Mindray DS Service Technician or authorized distributor. Please contact your authorized Mindray DS Service Representative for additional information.

Technical Support For technical assistance please contact your area or regional Mindray DS Patient Monitoring Representative. Additional information relating to the servicing and repair of the Viewstation OR is provided in the Viewstation OR Service Manual (P/N 0070-00-0665).

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Viewstation OR™ Operating Instructions

Symbols and Descriptions

Introduction

Symbols and Descriptions SYMBOL

DESCRIPTION

DESCRIPTION

Attention, Consult Accompanying Documents / Refer to Manual

Monitor

Alternating Current (AC)

Touch Screen

Direct Current (DC)

Earth Ground

Patient Network

Keyboard

Viewstation OR™ Operating Instructions

SYMBOL

Panorama Patient Network Ethernet

Mouse

Mark of compliance with U.S. and Canadian safety standards requirement.

Input/Output

Do not dispose of this product as unsorted municipal waste.

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Introduction

Symbols and Descriptions

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Viewstation OR™ Operating Instructions

1.0

System Overview

This section provides a high level view of the authorized components for the Viewstation OR. • The Viewstation OR • Basic Configuration • Supported Device

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1-1

The Viewstation OR

1.1

System Overview

The Viewstation OR Viewstation OR enables real-time clinical data to be presented on an independent, remote, secondary display for surgeons and perfusionists. The Viewstation OR CPU receives data from a Spectrum OR™ and transmits it to the independent display which can be configured to meet the needs of various clinicians. (See section 1.2, Basic Configuration.) While accessing the tabs that are associated with the menu bar buttons, the Viewstation OR display automatically re-configures as a split-screen. The top half of the screen displays patient data while the bottom half of the screen is converted to a work space for simultaneously entering and modifying display configurations.

1.2

Basic Configuration As depicted in FIGURE 1-1, the basic configuration of the Viewstation OR is: • Spectrum OR Bedside Monitor • Viewstation OR computer (CPU) • Independent Display • Touch Pad

INDEPENDENT DISPLAY

TOUCH PAD

SPECTRUM OR MONITOR

CPU

FIGURE 1-1 Basic Components of the Viewstation OR This configuration can be varied to include two identically configured displays per Viewstation OR computer and may also access the Spectrum OR monitor through an Ethernet network switch (see FIGURE 1-2).

1-2

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Viewstation OR™ Operating Instructions

System Overview

Basic Configuration

SPECTRUM OR MONITOR

ELAN ETHERNET

8 PORT SWITCH

CPU

CPU

TO PANORAMA OR GATEWAY

VIDEO SPLITTER

CPU

VGA

TOUCH SCREEN

VGA

EXTERNAL DISPLAY TOUCH PAD

EXTERNAL DISPLAY

EXTERNAL DISPLAY TOUCH PAD

FIGURE 1-2 Example Multiple Display Configuration of the Viewstation OR

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Supported Device

System Overview

1.3

Supported Device

1.3.1

Spectrum OR™ All Viewstation OR data is sourced from the Spectrum OR, a vital signs bedside monitor designed specifically for the operating room environment. The following table lists the Spectrum OR parameters that are supported by the Viewstation OR. SUPPORTED PARAMETERS HR PVC/min Resp NIBP (S/D/M) SpO2 IBP1 (S/D/M) IBP2 (S/D/M) IBP3 (S/D/M) IBP4 (S/D/M) I/E CO2 T1 T2 T Blood CO CI CCO CCI SvO2 PAWP NOTE:

1-4

The Viewstation OR does not display or annunciate physiological or technical alarms. All physiological alarms originate in the Spectrum OR.

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Viewstation OR™ Operating Instructions

2.0

Viewstation OR Main Screen

This section provides an overview of the Viewstation OR main screen.

2.1

The Main Screen The Main Screen for the Viewstation OR is used to display patient data and to navigate the system. The Main Screen includes the following elements: •

Waveform Parameter Tiles

•

Digital Parameter Tiles

•

Menu Bar

•

System Status/Demographics Area

•

Date and Time

•

Display States

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2-1

The Main Screen

2.1.1

Viewstation OR Main Screen

Waveform Parameter Tiles Waveform parameter tiles are the core elements of the Viewstation OR system (see FIGURE 2-1). These tiles display patient data obtained from the Spectrum OR™. Three to eight waveform parameter tiles may be displayed at once. Each waveform parameter tile is divided into two sections: •

Waveform Area

•

Waveform Digital Area

FIGURE 2-1 Example Waveform Parameter Tile

Configuring Waveform Parameter Tiles 1. Select the desired waveform parameter tile. The waveform configuration dialog box opens (see the examples in FIGURE 2-2 and FIGURE 2-3). The configuration options include Sensor Color, Wave Gain (all waveforms except SpO2), Change To and Pacer Enhancement (ECG1 waveform only). The Pacer Enhancement factory default setting is OFF.

FIGURE 2-2 Example ECG Waveform Configuration Dialog

FIGURE 2-3 Example IBP Waveform Configuration Dialog

2-2

NOTE:

The Change To choice control is based on the sensors utilized by the Spectrum OR. When viewing the top waveform area, the Change To choices are limited to ECG waveforms only.

NOTE:

The Change To choice control is hidden in ECG waveforms when a 3-wire ECG lead set is utilized by the Spectrum OR.

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Viewstation OR™ Operating Instructions

Viewstation OR Main Screen

The Main Screen

2. Select the Done or Cancel button. • The Done button accepts the changes. • The Cancel button rejects the changes.

2.1.1.1

NOTE:

Changes made in the Waveform Configuration Dialog box apply to both the Waveform Area and the Waveform Digital Area.

NOTE:

Changes made in the Waveform Configuration Dialog box will be reflected in the Display Tab, and vice versa.

Waveform Area The waveform area displays waveform data parameters. The following is a list of the available waveform areas.

FIGURE 2-4 Example ECG Waveform Area •

The ECG1 waveform is always located in the top waveform area. Based on the ECG lead set that is in use, other ECG waveforms can be displayed in other waveform areas. A scale bar is viewable and wave gain settings are displayed. Filters set at the Spectrum OR™ can be viewed in this area, including Monitor bandwidth (“MON”), Extended bandwidth (“EXT”) and ST bandwidth (“ST”).

•

The SpO2 waveform area displays an SpO2 waveform.

•

The IBP1 through IBP4 waveforms include a scale bar and wave gain settings. When an IBP area has been labeled at the Spectrum OR, the label will also display in the Viewstation OR. Wave gain settings include 0 – 20, 0 – 40, 0 – 80, 60 – 140, 0 – 160, 0 – 225, 0 – 320, and (-10) – 10 mmHg.

•

The Respiration waveform area includes a scale and wave gain settings. The wave gain choices include 1, 2, 3, 4, and 5.

•

The CO2 waveform area displays the wave gain scale with the associated unit of measure (mmHg, %, or kPa) as set at the Spectrum OR.

Waveforms are shown in a configured color and wave gain. If individual configurations are not set, the system default settings are used. A waveform can be displayed in more than one tile.

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