Accutorr 7 Operators Manual Rev 3 Jan 2015

© Copyright 2013-2015 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. All rights reserved. Release date: January 2015. Revision: 3.0

Accutorr 7 Operator's Manual

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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  

II

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.

Accutorr 7 Operator's Manual

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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.

Company Contact

IV

Manufacturer:

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Address

Mindray Building, Keji 12th Road South, Hi-tech industrial park, Nanshan, Shenzhen 518057, P.R.China

Website

www.mindray.com

E-mail Address:

[email protected]

Tel:

+86 755 81888998

Fax:

+86 755 26582680

Distributor:

Mindray DS USA, Inc.

Address:

800 MacArthur Boulevard, Mahwah, New Jersey 07430 USA

Tel:

1.800.288.2121, 1.201.995.8000

Website:

www.mindray.com

EC-Representative:

Shanghai International Holding Corp. GmbH (Europe)

Address:

Eiffestraβe 80, 20537 Hamburg, Germany

Tel:

0049-40-2513175

Fax:

0049-40-255726

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.

Accutorr 7 Operator's Manual

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FOR YOUR NOTES

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Accutorr 7 Operator's Manual

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 ... 2-13 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... 3-3 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 ... 3-4 3.3.1 Turning Power On ... 3-4 3.3.2 Turning off the Monitor... 3-5 3.4 Using Key, Knob, Touchscreen ... 3-5 3.4.1 Using Keys ... 3-5 3.4.2 Using the Knob... 3-6 3.4.3 Using the Touchscreen ... 3-6 3.5 Changing General Settings ... 3-6 3.5.1 Setting up a Monitor ... 3-6 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 Adjusting Alarm Volume... 3-7 3.5.5 Adjusting Key Volume ... 3-7 3.5.6 Adjusting the Screen Brightness ... 3-7 3.5.7 Setting Screen ... 3-8 3.5.8 Configuring the Timeout of Measured Value... 3-8 3.5.9 Configuring Measurement Colors ... 3-8 3.5.10 Setting the Date and Time... 3-8 3.5.11 Configuring Unit ... 3-9 3.5.12 Configuring Printout ... 3-9 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]... 4-2 4.2 Manually Input Patient Data... 4-3 4.3 Manually Save Patient Data ... 4-5 4.4 Reviewing Patient Data ... 4-5 4.4.1 Spot Check Trends ... 4-6 4.4.2 Continuous Trends ... 4-7 4.4.3 Graphic Trends... 4-8 4.5 Transferring Data from the Monitor to USB Drive ... 4-9 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 ... 6-2 6.3.3 Alarm Messages ... 6-3 6.3.4 Flashing Numerics... 6-3 2

Accutorr 7 Operator's Manual

6.3.5 Alarm Status Symbols ... 6-3 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... 6-6 6.6 Pausing Alarms ... 6-7 6.7 Switching Off Alarm Sound ... 6-8 6.8 Resetting Alarms ... 6-8 6.9 Setting the Reminder Tone ... 6-9 6.10 Latching Alarms ... 6-9 6.11 Actions for Alarm Occurrence ... 6-10 6.12 Nurse Call ... 6-10 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 ... 9-3 9.4 NIBP Measurement Mode... 9-3 Accutorr 7 Operator's Manual

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9.5 Measuring NIBP ... 9-4 9.5.1 Preparing the Patient ... 9-4 9.5.2 Preparing to Measure NIBP ... 9-4 9.5.3 Starting NIBP measurement... 9-5 9.5.4 Stopping NIBP Measurement ... 9-5 9.5.5 Correcting the Measurement when Cuff is not at Heart Level ... 9-5 9.6 Understanding the NIBP Numerics ... 9-6 9.7 Setting NIBP ... 9-6 9.7.1 Setting Interval ... 9-7 9.7.2 Setting the Initial Cuff Inflation Pressure... 9-7 9.7.3 Setting NIBP End Tone ... 9-7 9.7.4 Switching On/Off Measurement on Clock ... 9-7 9.7.5 Configuring a Custom Program ... 9-8 9.7.6 Setting NIBP Alarm Properties ... 9-8 9.7.7 Setting the Pressure Unit... 9-8 9.8 Assisting Venous Puncture ... 9-8 10 Monitoring Temp ... 10-1 10.1 Overview ... 10-1 10.2 Setting Temp ... 10-2 10.3 Preparation ... 10-2 10.3.1 Selecting Measuring Site ... 10-2 10.3.2 Taking a Temperature in Predictive Mode ... 10-3 10.3.3 Taking a Temperature in Monitor Mode ... 10-4 10.4 Disinfecting Temperature Probe ... 10-5 11 Recording ... 11-1 11.1 Using a Recorder ... 11-1 11.2 Loading Paper ... 11-1 11.3 Setting the Recorder ... 11-2 11.4 Starting and Stopping Recordings ... 11-2 11.5 Reports ... 11-3 11.5.1 Real-time Recording ... 11-3 11.5.2 Graphic Trend Recording ... 11-3 11.5.3 Continuous Trends Recording... 11-3 11.5.4 Spot Check Trends Recording ... 11-4 11.6 Removing a Paper Jam... 11-4 11.7 Cleaning the Recorder Printhead... 11-4 12 Other Functions ... 12-1 12.1 MEWS System ... 12-1 12.2 Network ... 12-2 12.2.1 Network Connection ... 12-2 4

Accutorr 7 Operator's Manual

12.2.2 Network Type and Settings ... 12-3 12.2.3 Setting up the Wireless Network (Optional) ... 12-4 12.2.4 ADT Communication Setup ... 12-4 12.2.5 EMR Communication Setup... 12-5 12.2.6 DIAP Communication Setup... 12-5 12.2.7 Central Monitoring System Setup ... 12-5 12.2.8 Setting the Multicast Parameters ... 12-5 13 Battery ... 13-1 13.1 Overview ... 13-1 13.2 Charging a Battery ... 13-2 13.3 Replacing a Battery... 13-2 13.4 Battery Guidelines ... 13-2 13.5 Battery Maintenance ... 13-3 13.5.1 Conditioning a Battery... 13-3 13.5.2 Checking a Battery ... 13-4 13.6 Recycling a Battery ... 13-4 14 Care and Maintenance ... 14-1 14.1 Cleaning and Disinfection ... 14-1 14.1.1 Cleaning ... 14-2 14.1.2 Disinfecting ... 14-2 14.2 General Inspection ... 14-3 14.3 Maintenance and Testing Schedule ... 14-3 14.4 Checking Monitor Information ... 14-5 14.7 Battery Check... 14-6 14.8 Calibrating the Touchscreen ... 14-6 14.9 Formatting the Storage Card ... 14-6 14.10 Modifying Password ... 14-6 15 Accessories ... 15-1 15.1 SpO2 Accessories ... 15-1 15.2 NIBP Accessories ... 15-2 15.3 Temp Accessories ... 15-3 15.4 Others ... 15-3 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 Measurement Specifications... A-4 Accutorr 7 Operator's Manual

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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 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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Accutorr 7 Operator's Manual

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.

Accutorr 7 Operator's Manual

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1.1.1 Warnings WARNING  

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When disposing of the packaging material, be sure to observe the applicable waste control regulations and keep it out of children’s reach.

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When no battery is installed, make sure that the power supply is continuous. A power interruption will result in patient data loss. Put the equipment in a location where you can easily see the screen, access the operating controls, and disconnect the equipment from AC power. 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. The equipment is not intended to be used within the magnetic resonance (MR) environment.

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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. 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). 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 is not intended to be directly used for diagnostic interpretation and replace the competent judgment of a clinician. 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.

Accutorr 7 Operator's Manual

1.1.2 Cautions CAUTION     

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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. At the end of its service life, the equipment, and its accessories, must be disposed of in compliance with the guidelines regulating the disposal of such products. If you have any questions concerning disposal of the equipment, please contact Mindray. 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. Before connecting the equipment to the power line, check that the voltage and frequency ratings of the power line are compatible with those indicated on the equipment’s label or in this manual. Always install or carry the equipment properly to avoid damage caused by a drop, impact, strong vibration or other mechanical force. If you spill liquid on the equipment or accessories, contact Mindray or your service personnel.

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1.1.3 Notes NOTE      

Keep this manual in the vicinity of the equipment so that it can be easily located when needed. The software was developed in compliance with IEC60601-1-4. The possibility of hazards arising from software errors is minimized. This manual describes all the equipment features and options. Your equipment may not have all of them. During normal use, the operator is expected to face the front of the equipment. Put the equipment in a location where you can easily view and operate the equipment. The equipment uses a mains plug asa means of isolation to the mains power supply. Do not position the equipment in a place difficult to access the mains plug.

1.2 Equipment Symbols Some symbols may not appear on your equipment.

1-4

Caution

ON/OFF for a part of equipment

Alternating current

Battery indicator

Alarm Reset

NIBP Start/Stop key

ALARM PAUSED

Graphical recorder

Admit patient key

Insertion Direction

DEFIBRILLATION –PROOF TYPE CF APPLIED PART

Input/Output

Network connector

Equipotentiality

USB connector

MANUFACTURER

Accutorr 7 Operator's Manual

Serial number

DATE OF MANUAFACTURE

CATALOGUE NUMBER

Protection against fluid ingress

Temperature limit

Humidity limitation

Atmospheric pressure limitation

Refer to instruction manual/ booklet

AUTHORISED Interference may occur in REPRESENTATIVE IN THE the vicinity of equipment EUROPEAN COMMUNITY marked with this symbol The product bears CE mark indicating its conformity with the provisions of the Council Directive 93/42/EEC concerning medical devices and fulfills the essential requirements of Annex I of this directive. The following definition of the WEEE label applies to EU member states only. This symbol indicates that this product should not be treated as household waste. By ensuring that this product is disposed of correctly, you will help prevent bringing potential negative consequences to the environment and human health. For more detailed information with regard to returning and recycling this product, please consult the distributor from whom you purchased it. * For system products, this label may be attached to the main unit only. The presence of this label indicates the machine was certified by ETL with the statement: Conforms to AAMI Std ES 60601-1, IEC Std 60601-1-6, IEC Std 60601-1-8, IEC Std 60601-2-49, IEC Std 80601-2-30, ISO Std 80601-2-56, ISO Std 80601-2-61. Certified to CSA Std C22.2 NO. 60601-1, NO. 60601-1-6, NO. 60601-1-8, NO. 60601-2-49, NO. 80601-2-30, NO. 80601-2-56, NO. 80601-2-61.

Accutorr 7 Operator's Manual

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FOR YOUR NOTES

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Accutorr 7 Operator's Manual

2 The Basics 2.1 Intended Use The monitor is intended for monitoring physiologic parameters, including Pulse Oximetry (SpO2), Pulse Rate (PR), Non Invasive Blood Pressure (NIBP) and Temperature (TEMP), on adult, pediatric, and neonatal patients in healthcare facilities by physicians or appropriate medical staff under the direction of physicians. This monitor is intended for use only by clinical professionals or under their guidance. It must only be used by persons who have received adequate training in its use.

2.2 Applied Parts The applied parts of the monitor are SpO2 sensor and cable, NIBP tubing and cuff, and Temp probes and cable.

Accutorr 7 Operator's Manual

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