Accutorr 3 Operators Manual Rev 2 Oct 2014

© Copyright 2013-2014 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. All rights reserved. For this Operator’s Manual, the issue date is October 2014.

Accutorr 3 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  

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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. Neglecting this may result in machine breakdown or personal injury.

Accutorr 3 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’s 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.

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. Accutorr 3 Operator's Manual

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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

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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: Fax:

0049-40-2513175 0049-40-255726

Accutorr 3 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 questions, 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 a 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 3 Operator's Manual

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FOR YOUR NOTES

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Accutorr 3 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 ... 1-5 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 ... 2-3 2.3.3 Rear View ... 2-4 2.3.4 Bottom View ... 2-5 2.4 Display Screen... 2-6 3 Basic Operation... 3-1 3.1 Installation... 3-1 3.1.1 Unpacking and Checking ... 3-1 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 Standby ... 3-5 3.4.1 Entering Standby Mode ... 3-5 3.4.2 Exiting Standby Mode ... 3-6 3.5 Using Keys ... 3-6 3.6 Parameter Setup Mode ... 3-8 3.7 Maintenance Mode ... 3-8 3.7.1 Selecting NIBP Unit of Measure ... 3-8 3.7.2 Selecting Temp Unit of Measure... 3-9 3.7.3 Setting System Time... 3-9 3.7.4 Viewing Software Version... 3-10 3.7.5 Loading Factory Default Configuration ... 3-10 3.7.6 Viewing Operated Time ... 3-11 Accutorr 3 Operator's Manual

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3.7.7 Adjusting the Screen Brightness ... 3-12 3.7.8 DIAP Communication Setup ... 3-13 4 Monitoring SpO2 ... 4-1 4.1 Overview ... 4-1 4.2 Safety ... 4-2 4.3 Identifying SpO2 Module ... 4-2 4.4 Applying the Sensor ... 4-3 4.5 Switching Pulse Tone On/Off ... 4-3 4.6 Measurement Limitations ... 4-4 4.7 Masimo Information ... 4-5 4.8 Nellcor Information... 4-5 5 Monitoring NIBP ... 5-1 5.1 Overview ... 5-1 5.2 Safety ... 5-1 5.3 Measurement Limitations ... 5-2 5.4 Measuring NIBP ... 5-2 5.4.1 Preparing the Patient ... 5-2 5.4.2 Preparing to Measure NIBP ... 5-3 5.4.3 Starting and Stopping Measurements ... 5-4 5.4.4 Correcting the Measurement when Cuff is not at Heart Level ... 5-4 5.5 Understanding the NIBP Numerics ... 5-4 5.6 Care and Cleaning of Reusable Cuffs ... 5-5 5.6.1 Reusable Cuffs with Bladders ... 5-5 5.6.2 Reusable Bladderless Cuffs ... 5-6 6 Monitoring Temp ... 6-1 6.1 Overview ... 6-1 6.2 Selecting Measurement Site ... 6-2 6.3 Taking a Temperature ... 6-3 6.3.1 Entering Predictive Mode and Monitor Mode ... 6-3 6.3.2 Taking a Temperature in the Predictive Mode... 6-3 6.3.3 Taking a Temperature in Monitor Mode ... 6-4 6.4 Disinfecting Temperature Probe ... 6-5 7 Battery ... 7-1 7.1 Overview ... 7-1 7.2 Charging a Battery ... 7-1 7.3 Replacing a Battery ... 7-2 7.4 Battery Guidelines ... 7-2 7.5 Battery Maintenance ... 7-3 7.5.1 Conditioning a Battery ... 7-3 7.5.2 Checking a Battery ... 7-3 2

Accutorr 3 Operator's Manual

7.6 Recycling a Battery... 7-4 8 Care and Maintenance... 8-1 8.1 Cleaning and Disinfection ... 8-1 8.1.1 Cleaning ... 8-2 8.1.2 Disinfecting ... 8-2 8.2 General Inspection ... 8-3 8.3 Maintenance and Testing Schedule ... 8-3 8.4 Checking Monitor Information... 8-4 8.5 Visual Inspection ... 8-4 8.6 Power-on Test... 8-4 8.7 Battery Check ... 8-4 9 Accessories ... 9-1 9.1 SpO2 Accessories ... 9-1 9.2 NIBP Accessories ... 9-2 9.3 Temp Accessories... 9-3 9.4 Others ... 9-4 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-3 B EMC ... B-1 C Error Codes... C-1 D Symbols and Abbreviations ...D-1 D.1 Symbols ... D-1 D.2 Abbreviations ... D-2

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FOR YOUR NOTES

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Accutorr 3 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 3 Operator's Manual

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1.1.1 Warnings WARNING 

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The monitor does not provide any alarms. It only provides error codes and is not intended for continuous monitoring. Keep the patient under close surveillance when using this monitor. 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 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. 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 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. The physiological data and prompt information 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 to prevent a stumbling hazard. Wrap and secure excess cabling to reduce risk of entanglement by patients or personnel. When disposing of the packaging material, be sure to observe the applicable waste control regulations and keep it out of children’s reach. When no battery is installed, make sure that the power supply is continuous. A power interruption will result in 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 access the mains plug. The equipment is not intended to be used within the magnetic resonance (MR) environment.

Accutorr 3 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 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 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 

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The equipment is intended to be used for immediate, supervised, point of care monitoring, and not for continuous monitoring. The equipment cannot be configured to obtain periodic physiological measurements at set intervals; rather, it is used by a healthcare provider to obtain an immediate measurement. 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. Only connect the specified device into an RS-232 connector. During normal use, the operator is expected to face the front of the equipment.

Accutorr 3 Operator's Manual

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

Caution

Neonate

ON/OFF for a part of equipment

Pediatric

Clear key

Adult

Alternating current

Equipotentiality

Battery indicator

Input/Output

DEFIBRILLATION –PROOF TYPE CF APPLIED PART

DATE OF MANUAFACTURE

NIBP Start/Stop key

MANUFACTURER

Protection against fluid ingress

Insertion Direction

Serial number

Alarm inhibit

Refer to instruction manual/ booklet

Atmospheric pressure limitation

Temperature limit

Humidity limitation

Interference may occur in the vicinity of equipment marked with this symbol

CATALOGUE NUMBER

AUTHORISED REPRESENTATIVE IN THE EUROPEAN COMMUNITY 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.

Accutorr 3 Operator's Manual

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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. 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. 80601-2-30, NO. 80601-2-56, NO. 80601-2-61.

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Accutorr 3 Operator's Manual

2 The Basics 2.1 Intended Use The monitor is intended for spot-check 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 3 Operator's Manual

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2.3 Main unit 2.3.1 Front View 10

9 1 8

2

3

4 1. 2.

3.

2-2

5

6

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Display screen AC power indicator  On: indicates that the monitor is connected to the AC power.  Off: indicates that the monitor is not connected to the AC power. Power ON/OFF switch  Press this key to turn the monitor on.  If no parameter is being measured, press this key to enter Standby mode.  When the monitor is on, press and hold this key for more than 2 seconds to turn the monitor off. An indicator is built into this switch. It turns green when the monitor is on, turns yellow when the monitor enters Standby mode, and turns off when the monitor is off.

Accutorr 3 Operator's Manual

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Battery indicator On: indicates that the battery is installed and the AC power is connected.  Off: indicates that no battery is installed when AC power is connected, or indicates that the battery is installed, but no AC power is connected when the monitor is powered off.  Flashing: indicates that the monitor is powered by battery. 5. Clear key  In Measurement mode, press this key to clear currently displayed measurements and error code.  In Measurement mode, press and hold this key for more than 2 seconds to access the Parameter Setup mode.  When the monitor is starting up and a beep is heard, press and hold this key immediately (within 10 seconds after the beep) to access the Maintenance mode. 6. Patient Category key  In Measurement mode, press this key to toggle among adult, pediatric and neonate. 7. NIBP Start/Stop key  In Measurement mode, press this key to start or stop an NIBP measurement. 8. Probe cover pack holder 9. Temperature probe well 10. Handle 

2.3.2 Side View

P NIB 2 SpO

1

1. 2.

2

Connector for SpO2 cable Connector for NIBP cuff

Accutorr 3 Operator's Manual

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