MINDRAY
Accutorr 3 Vital Signs Monitor Operating Instructions Rev 12.0 Nov 2021
Operating Instructions
100 Pages
Preview
Page 1
Vital Signs Monitor Operator’s Manual
© Copyright 2013-2021 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. All rights reserved. Release date: November 2021 Revision: 12.0
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. This posting serves as notice under 35 U.S.C.§287(a) for Mindray patents: http://www.mindrayna.com/patents.
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 Accutorr 3 Operator's Manual
perform a reasonable service/maintenance plan. Neglecting this may result in machine breakdown or personal injury.
Company Contact Manufacturer:
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Address
Mindray Building, Keji 12th Road South, High-tech industrial park, Nanshan, Shenzhen 518057, P.R.China
Website
www.mindray.com
E-mail Address:
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
Accutorr 3 Operator's Manual
III
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
IV
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
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 ... 3-4 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 Accutorr 3 Operator's Manual
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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 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 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 ... 7-2 7.3 Replacing a Battery ... 7-2 7.4 Battery Guidelines ... 7-2 2
Accutorr 3 Operator's Manual
7.5 Battery Maintenance ... 7-3 7.5.1 Conditioning a Battery ... 7-3 7.5.2 Checking a Battery ... 7-3 7.6 Recycling a Battery... 7-4 8 Care and Cleaning... 8-1 8.1 General Points ... 8-1 8.2 Cleaning and Disinfecting the Main Unit ... 8-2 8.2.1 Aprroved Cleaning and Disinfecting Agents ... 8-2 8.2.2 Cleaning the Main Unit ... 8-4 8.2.3 Disinfecting the Main Unit ... 8-4 8.3 Cleaning and Disinfecting the Accessories... 8-5 8.3.1 Aprroved Accessories Cleaning and Disinfecting Agents... 8-5 8.3.2 Cleaning the Accessories... 8-8 8.3.3 Disinfecting the Accessories ... 8-8 8.4 Sterilization ... 8-8 9 User Maintenance ... 9-1 9.1 General Inspection ... 9-1 9.2 Maintenance and Testing Schedule ... 9-1 9.3 Checking Monitor Information... 9-2 9.4 Visual Inspection ... 9-2 9.5 Power-on Test... 9-3 9.6 Battery Check ... 9-3 10 Accessories ... 10-1 10.1 SpO2 Accessories ... 10-1 10.2 NIBP Accessories ... 10-2 10.3 Temp Accessories ... 10-3 10.4 Others ... 10-3 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-3 B EMC ... B-1 C Error Codes... C-1 D Symbols and Abbreviations ...D-1 Accutorr 3 Operator's Manual
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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.
Accutorr 3 Operator's Manual
1-1
1.1.1 Warnings WARNING
1-2
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
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.
Contact the Mindray service personnel for replacements if you find the housing is broken.
Accutorr 3 Operator's Manual
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1.1.3 Notes NOTE
1-4
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.
Put the equipment in a location where you can easily view and operate the equipment.
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. 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. General warning sign
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
Non-ionizing electromagnetic radiation
CATALOGUE NUMBER
AUTHORISED REPRESENTATIVE IN THE EUROPEAN COMMUNITY
Plastics identification symbol
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
7
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
4.
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
NIB 2
SpO
1
Accutorr 3 Operator's Manual
P
2
2-3
1. 2.
Connector for SpO2 cable Connector for NIBP cuff
2.3.3 Rear View 1
2
4 3 5 6
1. 2. 3. 4.
5 6.
Handle Temperature probe well Connector for temperature probe Input/Output connector (RS-232 connector) This connector can be used for software upgrade and DIAP (Datascope Improved ASCII Protocol) communication. AC power input Equipotential grounding terminal
NOTE
2-4
When using the equipment with other devices, their equipotential grounding terminals should be connected together to eliminate a possible difference in ground potential.
Accutorr 3 Operator's Manual
2.3.4 Bottom View
1
2
1. 2.
Battery compartment door Quick release mount latch point
Accutorr 3 Operator's Manual
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2.4 Display Screen 2
1
3
4
8
5
9
6
7
10 14
11 12
15
13 16
18
17
22
19
20 1. 2.
21
Patient category (Adult, Pediatric, Neonate) Error code
Refer to C Error Codes for additional information. System time Charge level indicator NIBP label NIBP unit of measure Systolic pressure Cuff pressure: displayed during NIBP measurement. NIBP cuff indicator When errors such as air leak, incorrect air pressure, weak signal, overpressure, incorrect cuff type, or excessive patient motion etc. occur, the cuff indicator displays. 10. Diastolic pressure 11 SpO2 label 12. SpO2 unit of measure 3. 4. 5. 6. 7. 8. 9.
2-6
Accutorr 3 Operator's Manual