MINDRAY
Accutorr 7 Vital Signs Monitor Operating Instructions Rev 4.0 SW Ver03.07.xx May 2016
Operating Instructions
168 Pages
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Vital Signs Monitor Operator’s Manual
© Copyright 2013-2016 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. All rights reserved. Release date: May 2016 Revision: 4.0
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Intellectual Property Statement SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. (hereinafter called Mindray) owns the intellectual property rights to this Mindray product and this manual. This manual may refer to information protected by copyrights or patents and does not convey any license under the patent rights of Mindray, nor the rights of others. Mindray intends to maintain the contents of this manual as confidential information. Disclosure of the information in this manual in any manner whatsoever without the written permission of Mindray is strictly forbidden. Release, amendment, reproduction, distribution, rental, adaption and translation of this manual in any manner whatsoever without the written permission of Mindray is strictly forbidden.
, , and are the registered trademarks or trademarks owned by Mindray in China and other countries. All other trademarks that appear in this manual are used only for editorial purposes without the intention of improperly using them. They are the property of their respective owners.
Manufacturer’s Responsibility Contents of this manual are subject to changes without prior notice. All information contained in this manual is believed to be correct. Mindray is not liable for errors contained herein nor for incidental or consequential damages in connection with the furnishing, performance, or use of this manual. Mindray is responsible for the effects on safety, reliability and performance of this product, only if: all installation operations, expansions, changes, modifications and repairs of this product are conducted by Mindray authorized personnel; the electrical installation of the relevant room complies with the applicable national and local requirements; the product is used in accordance with the instructions for use.
WARNING
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Only skilled/trained clinical professionals should operate this equipment. It is important for the hospital or organization that uses this equipment to perform a reasonable service/maintenance plan. Neglect of this may result in machine breakdown or personal injury.
Accutorr 7 Operator's Manual
Warranty Mindray warrants that components within its products will be free from defects in workmanship and materials for a period of three years from the date of purchase except that disposable or one-time use products are warranted to be free from defects in workmanship and materials up to a date one year from the date of purchase or the date of first use, whichever is sooner. This warranty does not cover consumable items such as, but not limited to, batteries, external cables, and sensors. Mindray shall not be liable for any incidental, special, or consequential loss, damage, or expense directly or indirectly arising from the use of its products. Liability under this warranty and the buyer’s exclusive remedy under this warranty is limited to servicing or replacing the affected products, at Mindray option, at the factory or at an authorized distributor, for any product which shall under normal use and service appear to Mindray to have been defective in material or workmanship. Recommended preventative maintenance, as prescribed in the service manual, is the responsibility of the user and is not covered by this warranty. No agent, employee, or representative of Mindray has any authority to bind Mindray to any affirmation, representation, or warranty concerning its products, and any affirmation, representation or warranty made by any agent, employee, or representative shall not be enforceable by buyer or user. THIS WARRANTY IS EXPRESSLY IN LIEU OF, AND MINDRAY EXPRESSLY DISCLAIMS, ANY OTHER EXPRESS OR IMPLIED WARRANTIES, INCLUDING ANY IMPLIED WARRANTY OF MERCHANTABILITY, NON-INFRINGEMENT, OR FITNESS FOR A PARTICULAR PURPOSE, AND OF ANY OTHER OBLIGATION ON THE PART OF MINDRAY. Damage to any product or parts through misuse, neglect, accident, or by affixing any non-standard accessory attachments, or by any customer modification voids this warranty. Mindray makes no warranty whatsoever in regard to trade accessories, such being subject to the warranty of their respective manufacturers. A condition of this warranty is that the equipment or accessories which are claimed to be defective be returned when authorized, freight prepaid to Mindray DS USA, Inc., Mahwah, New Jersey 07430 or its authorized representative. Mindray shall not have any responsibility in the event of loss or damage in transit.
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Exemptions Mindray's obligation or liability under this warranty does not include any transportation or other charges or liability for direct, indirect or consequential damages or delay resulting from the improper use or application of the product or the use of parts or accessories not approved by Mindray or repairs by people other than Mindray authorized personnel. This warranty does not extend to: Malfunction or damage caused by improper use or man-made failure. Malfunction or damage caused by unstable or out-of-range power input. Malfunction or damage caused by force majeure events, such as (i) flood, fire and earthquake or other similar elements of nature or acts of God; (ii) riots, war, civil disorders, rebellions, or revolutions in any country; or (iii) any other cause beyond the reasonable control of Mindray. Malfunction or damage caused by improper operation or repair by unqualified or unauthorized service people. Malfunction of the instrument or part whose serial number is not legible. Others not caused by instrument or part itself.
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Accutorr 7 Operator's Manual
Service Mindray maintains a network of service representatives and factory-trained distributors. Prior to requesting service, perform a complete operational check of the instrument to verify proper control settings. If operational problems continue to exist, In North America contact the Service Department at (800) 288-2121, ext: 8116 for Technical Support or (201) 995-8000 for assistance in determining the nearest field service location. Please include the instrument model number, the serial number, and a description of the problem with all requests for service. Any questions regarding the warranty should be directed to your local sales or service representative. NOTE
Upon request, Mindray provides circuit diagrams, component part lists, descriptions, calibration instructions, or other information which assist the user’s appropriately qualified technical personnel to repair those parts of the equipment which are designated by Mindray DS USA, Inc. as repairable.
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Company Contact Manufacturer:
Website E-mail Address: Tel: Fax: Distributor: Address: Tel: Website:
Mindray DS USA, Inc. 800 MacArthur Boulevard, Mahwah, New Jersey 07430 USA 1.800.288.2121, 1.201.995.8000 www.mindray.com
EC-Representative: Address: Tel: Fax:
Shanghai International Holding Corp. GmbH (Europe) Eiffestraβe 80, 20537 Hamburg, Germany 0049-40-2513175 0049-40-255726
Address
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Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Mindray Building, Keji 12th Road South, Hi-tech industrial park, Nanshan, Shenzhen 518057, P.R.China www.mindray.com [email protected] +86 755 81888998 +86 755 26582680
Accutorr 7 Operator's Manual
Preface Manual Purpose This manual contains the instructions necessary to operate the product safely and in accordance with its function and intended use. Observance of this manual is a prerequisite for proper product performance and correct operation and ensures patient and operator safety. This manual is based on the maximum configuration and therefore some contents may not apply to your product. If you have any question, please contact Mindray. This manual is an integral part of the product. It should always be kept close to the equipment so that it can be conveniently obtained when needed.
Intended Audience This manual is intended for clinical professionals who are expected to have corresponding working knowledge of medical procedures, practices and terminology as required for the monitoring of patients.
Illustrations All illustrations in this manual serve as examples only. They may not necessarily reflect the setup or data displayed on your equipment.
Manual Conventions
Italic text is used to quote the referenced chapters or sections. [ ] is used to enclose screen text. → is used to indicate operational procedures.
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FOR YOUR NOTES
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Contents 1 Safety ... 1-1 1.1 Safety Information... 1-1 1.1.1 Warnings ... 1-2 1.1.2 Cautions ... 1-3 1.1.3 Notes ... 1-4 1.2 Equipment Symbols ... 1-4 2 The Basics ... 2-1 2.1 Intended Use ... 2-1 2.2 Applied Parts ... 2-1 2.3 Main unit ... 2-2 2.3.1 Front View ... 2-2 2.3.2 Side View ... 2-4 2.3.3 Rear View ... 2-5 2.3.4 Bottom View ... 2-6 2.4 Main Screen ... 2-7 2.5 Menu ... 2-11 2.6 Operating Modes... 2-11 2.6.1 Monitor Mode ... 2-11 2.6.2 Spot Check Mode ... 2-12 2.6.3 Standby Mode ... 2-12 2.6.4 Demo Mode... 2-13 3 Basic Operation... 3-1 3.1 Installation... 3-1 3.1.1 Unpacking and Checking ... 3-2 3.1.2 Environmental Requirements... 3-2 3.2 General Operation... 3-2 3.2.1 Connection to AC Power ... 3-3 3.2.2 Using a Battery ... 3-3 3.2.3 Connecting Accessories ... 3-3 3.3 Turning On/Off Power ... 3-3 3.3.1 Turning Power On ... 3-3 3.3.2 Turning off the Monitor... 3-4 3.4 Using Key, Knob, Touchscreen ... 3-5 3.4.1 Using Keys ... 3-5 3.4.2 Using the Knob... 3-5 3.4.3 Using the Touchscreen ... 3-5 3.5 Changing General Settings ... 3-5 3.5.1 Setting up a Monitor ... 3-5 Accutorr 7 Operator's Manual
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3.5.2 Changing Language ... 3-6 3.5.3 Configuring the Timeout of Clinician ID ... 3-6 3.5.4 Showing/Hiding Patient Name ... 3-6 3.5.5 Adjusting Alarm Volume... 3-6 3.5.6 Adjusting Key Volume ... 3-7 3.5.7 Adjusting the Screen Brightness ... 3-7 3.5.8 Setting Screen ... 3-7 3.5.9 Configuring the Timeout of Measured Value... 3-7 3.5.10 Configuring Measurement Colors ... 3-8 3.5.11 Setting the Date and Time... 3-8 3.5.12 Configuring Unit ... 3-8 3.5.13 Configuring Printout ... 3-8 4 Patient Data Management ... 4-1 4.1 Admitting a Patient ... 4-1 4.1.1 Admitting a Patient by the Admit Patient Hardkey ... 4-1 4.1.2 Admitting a Patient by Barcode Scanner ... 4-2 4.1.3 Admitting a Patient from [Patient List]... 4-4 4.2 Manually Input Patient Data... 4-5 4.3 Manually Save Patient Data ... 4-6 4.4 Reviewing Patient Data ... 4-7 4.4.1 Spot Check Trends ... 4-7 4.4.2 Continuous Trends ... 4-8 4.4.3 Graphic Trends... 4-9 4.5 Transferring Data from the Monitor to USB Drive ... 4-10 5 Managing Configurations ... 5-1 5.1 Overview ... 5-1 5.2 Accessing [Manage Configuration] Menu... 5-1 5.2.1 Setting Default Configuration ... 5-2 5.3 Saving Current Settings... 5-2 5.4 Deleting a Configuration ... 5-2 5.5 Transferring a Configuration ... 5-3 5.6 Loading a Configuration ... 5-3 5.7 Restoring the Latest Configuration Automatically ... 5-3 6 Alarms ... 6-1 6.1 Alarm Categories ... 6-1 6.2 Alarm Levels... 6-2 6.3 Alarm Indicators ... 6-2 6.3.1 Alarm Lamp ... 6-2 6.3.2 Audible Alarm Tones ... 6-3 6.3.3 Alarm Messages ... 6-3 2
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6.3.4 Flashing Numerics... 6-3 6.3.5 Alarm Status Symbols ... 6-4 6.4 Setting Alarms ... 6-4 6.5 Selecting Alarm Properties ... 6-5 6.5.1 Changing the Alarm Volume... 6-5 6.5.2 Setting the Minimum Alarm Volume ... 6-5 6.5.3 Setting the Interval between Alarm Sounds ... 6-5 6.5.4 Adjusting Alarm Limits Automatically... 6-5 6.6 Pausing Alarms ... 6-7 6.7 Switching Off Alarm Sound ... 6-7 6.8 Resetting Alarms ... 6-7 6.9 Setting the Reminder Tone ... 6-8 6.10 Latching Alarms ... 6-8 6.11 Actions for Alarm Occurrence ... 6-9 6.12 Nurse Call ... 6-9 7 Monitoring SpO2 ... 7-1 7.1 Overview ... 7-1 7.2 Safety ... 7-2 7.3 Identifying SpO2 Module ... 7-2 7.4 Applying the Sensor ... 7-3 7.5 Changing SpO2 Settings... 7-3 7.5.1 Accessing SpO2 Menu ... 7-3 7.5.2 Adjusting the Desat Alarm... 7-3 7.5.3 Setting SpO2 Sensitivity ... 7-3 7.5.4 Changing Averaging Time ... 7-4 7.5.5 Monitoring SpO2 and NIBP Simultaneously ... 7-4 7.5.6 Sat-Seconds Alarm Management ... 7-4 7.5.7 Changing the Speed of Pleth Wave ... 7-6 7.5.8 Setting the Alarm Level for SpO2 Sensor Off Alarm ... 7-6 7.6 Measurement Limitations ... 7-6 7.7 Masimo Information ... 7-6 7.8 Nellcor Information... 7-7 8 Monitoring PR ... 8-1 8.1 Overview ... 8-1 8.2 PR Source ... 8-1 8.3 Pulse Tone ... 8-1 9 Monitoring NIBP ... 9-1 9.1 Overview ... 9-1 9.2 Safety ... 9-2 9.3 Measurement Limitations ... 9-2 Accutorr 7 Operator's Manual
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9.4 NIBP Measurement Mode... 9-3 9.5 Measuring NIBP ... 9-3 9.5.1 Preparing the Patient ... 9-3 9.5.2 Preparing to Measure NIBP ... 9-3 9.5.3 Starting NIBP measurement... 9-4 9.5.4 Stopping NIBP Measurement ... 9-4 9.5.5 Correcting the Measurement when Cuff is not at Heart Level ... 9-5 9.6 Understanding the NIBP Numerics ... 9-5 9.7 Setting NIBP ... 9-5 9.7.1 Setting Interval ... 9-5 9.7.2 Setting the Initial Cuff Inflation Pressure... 9-5 9.7.3 Setting NIBP End Tone ... 9-6 9.7.4 Switching On/Off Measurement on Clock ... 9-6 9.7.5 Configuring a Custom Program ... 9-6 9.7.6 Setting NIBP Alarm Properties ... 9-7 9.7.7 Setting the Pressure Unit... 9-7 9.8 Assisting Venous Puncture ... 9-7 9.9 Care and Cleaning of Reusable Cuffs ... 9-8 9.9.1 Reusable Cuffs with Bladders ... 9-8 9.9.2 Cleaning ... 9-8 9.9.3 Reusable Bladderless Cuffs ... 9-9 10 Monitoring Temp ... 10-1 10.1 Overview ... 10-1 10.1.1 Setting Temp... 10-2 10.2 Preparation ... 10-2 10.2.1 Selecting Measuring Site ... 10-2 10.2.2 Taking a Temperature in Predictive Mode ... 10-3 10.2.3 Taking a Temperature in Monitor Mode ... 10-4 10.3 Disinfecting Temperature Probe ... 10-4 11 Clinical Scoring ... 11-1 11.1 Overview ... 11-1 11.1.1 MEWS (Modified Early Warning Score) ... 11-1 11.1.2 NEWS (National Early Warning Score) ... 11-1 11.1.3 Customizable Scoring ... 11-2 11.2 Entering the Calculation Screen ... 11-2 11.2.1 Scoring Screen ... 11-2 11.2.2 Score Tile ... 11-2 11.3 Calculating a Score ... 11-3 11.4 Clinical Scoring Screen ... 11-3 11.4.1 Score Tile in the Main Screen ... 11-3 11.4.2 Scoring Screen ... 11-3 4
Accutorr 7 Operator's Manual
11.5 Obtaining the Total Score ... 11-5 11.6 Managing Scorings... 11-7 11.6.1 Importing the Scoring ... 11-7 11.6.2 Selecting Default Scoring ... 11-7 11.6.3 Deleting the Scoring... 11-7 11.6.4 Loading a Scoring ... 11-7 12 Recording ... 12-1 12.1 Using a Recorder ... 12-1 12.2 Loading Paper ... 12-1 12.3 Setting the Recorder ... 12-2 12.4 Starting and Stopping Recordings ... 12-2 12.5 Reports ... 12-3 12.5.1 Real-time Recording ... 12-3 12.5.2 Graphic Trend Recording ... 12-3 12.5.3 Continuous Trends Recording... 12-3 12.5.4 Spot Check Trends Recording ... 12-4 12.6 Removing a Paper Jam... 12-4 12.7 Cleaning the Recorder Printhead... 12-4 13 Network... 13-1 13.1 Network Connection... 13-1 13.1.1 Selecting a Network Type ... 13-2 13.1.2 Setting the Wired Network... 13-2 13.1.3 Setting the Wireless Network (Optional) ... 13-2 13.1.4 WLAN Test ... 13-3 13.1.5 Selecting WLAN Band and Channels ... 13-4 13.1.6 Setting up the Wireless Network (Optional) ... 13-4 13.2 Setting Data Send Method ... 13-5 13.2.1 ADT Communication Setup ... 13-5 13.2.2 EMR Communication Setup... 13-5 13.2.3 NTP Server Setup ... 13-5 13.2.4 Realtime Data Send Interval (for HL7 only)... 13-6 13.2.5 Alarm Server Settings (for HL7 only) ... 13-6 13.3 Connecting the monitor to the CMS ... 13-6 13.3.1 Setting the CMS ... 13-6 13.3.2 Selecting a CMS ... 13-6 13.3.3 Clearing the Selected CMS at Startup ... 13-7 13.4 Managing Certificates ... 13-7 13.5 Setting the Multicast Parameters ... 13-7 13.5.1 DIAP Communication Setup... 13-7 14 Battery ... 14-1
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14.1 Overview ... 14-1 14.2 Charging a Battery ... 14-1 14.3 Replacing a Battery... 14-1 14.4 Battery Guidelines ... 14-2 14.5 Battery Maintenance ... 14-3 14.5.1 Conditioning a Battery... 14-3 14.5.2 Checking a Battery ... 14-3 14.6 Recycling a Battery ... 14-4 15 Care, Cleaning and Maintenance... 15-1 15.1 Cleaning and Disinfection ... 15-1 15.1.1 Cleaning ... 15-2 15.1.2 Disinfecting ... 15-2 15.1.3 Sterilization ... 15-3 15.2 General Inspection ... 15-3 15.3 Maintenance and Testing Schedule ... 15-3 15.4 Checking Monitor Information ... 15-4 15.5 Visual Inspection ... 15-5 15.6 Power-on Test ... 15-5 15.7 Battery Check... 15-6 15.8 Calibrating the Touchscreen ... 15-6 15.9 Formatting the Storage Card ... 15-6 15.10 Modifying Password ... 15-6 16 Accessories ... 16-1 16.1 SpO2 Accessories ... 16-1 16.2 NIBP Accessories ... 16-2 16.3 Temp Accessories ... 16-3 16.4 Others ... 16-3 A Product Specifications ... A-1 A.1 Classifications ... A-1 A.2 Environmental Specifications ... A-1 A.3 Power Supply Specifications ... A-2 A.4 Physical Specifications ... A-2 A.5 Hardware Specifications ... A-2 A.6 Wireless Network (Optional) ... A-4 A.7 Measurement Specifications... A-5 B EMC and Radio Regulatory Compliance ... B-1 B.1 EMC ... B-1 B.2 Radio Regulatory Compliance... B-5 C Default Configurations ... C-1 6
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C.1 Parameter Configuration... C-1 C.2 General Configuration... C-4 C.3 User Maintenance Items... C-5 D Alarm Messages ...D-1 D.1 Physiological Alarm Messages ... D-1 D.2 Technical Alarm Messages ... D-1 E Symbols and Abbreviations ... E-1 E.1 Symbols... E-1 E.2 Abbreviations ... E-3 F Anomalies... F-1 F.1 NIBP Smart Inflation Anomaly... F-1
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FOR YOUR NOTES
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1 Safety 1.1 Safety Information WARNING
Indicates a potential hazard situation or unsafe practice that, if not avoided, could result in death or serious injury.
CAUTION
Indicates a potential hazard or unsafe practice that, if not avoided, could result in minor personal injury or product/property damage.
NOTE
Provides application tips or other useful information to ensure that you get the most from your product.
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1.1.1 Warnings WARNING
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This equipment is restricted to one patient at a time. Before putting the system into operation, the operator must verify that the equipment, connecting cables and accessories are in correct working order and operating condition. To avoid risk of electric shock, this equipment must only be connected to a properly grounded power outlet. If a properly grounded power outlet is not available, operate the monitor on battery power. Ensure that the equipment is supplied with continuous electric power during operation. Sudden power failure may lead to the loss of patient data. The equipment is magnetic resonance (MR) unsafe. To avoid an explosion hazard, do not use the equipment in the presence of oxygen–rich atmospheres, flammable anesthetics, or other flammable agents (such as gasoline). Before connecting the equipment to a power line, check that the voltage and frequency ratings of the power line are the same as those indicated on the equipment’s label or in this manual. Do not open the equipment housings. All servicing or future upgrades must be carried out by Mindray trained and authorized personnel. Do not come into contact with patients during defibrillation. Otherwise serious injury or death could result. Do not touch the equipment’s metal parts or connectors when in contact with the patient; otherwise patient injury may result. Do not rely exclusively on the audible alarm system for patient monitoring. Adjustment of alarm volume to a low level or off may result in a hazard to the patient. Remember that alarm settings should be customized according to different patient situations and always keeping the patient under close surveillance is the most reliable way for safe patient monitoring. The physiological data and alarm messages displayed on the equipment should be reviewed by a clinician before being used for diagnostic interpretation and treatment. To avoid inadvertent disconnection, route all cables in a way to prevent a stumbling hazard. Wrap and secure excess cabling to reduce risk of entanglement by patients or personnel. The equipment uses a mains plug as isolation means to the mains power supply. Please do not position the equipment in a place difficult to operate the mains plug. Magnetic and electrical fields are capable of interfering with the proper performance of the equipment. For this reason, make sure that all external devices operated in the vicinity of the equipment comply with the relevant EMC requirements. Mobile phones and X-ray equipment are a possible source of interference as they may emit higher levels of electromagnetic radiation.
Accutorr 7 Operator's Manual
1.1.2 Cautions CAUTION
Only use parts and accessories specified in this manual. Remove the battery before shipping the monitor or if it will not be used for an extended period of time. Carefully route patient cabling to reduce the possibility of patient entanglement. Disposable accessories are not designed to be reused. Reuse may cause a risk of contamination and affect the measurement accuracy. Always install or carry the equipment properly to avoid damage caused by a drop, impact, strong vibration or other mechanical force. Dry the equipment immediately in case of rain or water spray. When no battery is installed, make sure that the power supply is continuous. A power interruption will result in patient data loss. Store and use the equipment in specified environmental condition. The monitor and accessories may not meet the performance specification due to aging, stored or used outside the specified temperature and humidity range.
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