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Introduction

BP10 Operator’s Manual

III

WARNING

•

Only skilled/trained clinical professionals shall operate this equipment.

•

It is important for the hospital or organization that employs this equipment
to carry out a reasonable service/maintenance plan. Neglect of 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:

[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

Содержание BP10 NIBP Module

Страница 1: ...BP10 NIBP Module Operator s Manual...

Страница 2: ......

Страница 3: ...dray Bio Medical Electronics Co Ltd All rights reserved WARNING Federal Law USA restricts this device to sale by or on the order of a physician or other practitioner licensed by U S state law to use o...

Страница 4: ...demarks 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 un...

Страница 5: ...lt 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...

Страница 6: ...y This manual is an integral part of the product It should always be kept close to the equipment so that it can be obtained conveniently when needed Intended Audience This manual is geared for clinica...

Страница 7: ...uirements 3 3 3 4 Installing the Batteries 3 4 3 5 Powering On the Device 3 6 3 6 Basic Operations 3 6 3 6 1 Entering the Main Menu 3 6 3 6 2 Selecting and Configuring an Option 3 7 3 6 3 Turning the...

Страница 8: ...General NIBP Setup 6 6 6 5 2 Advanced NIBP Setup Passcode Protected 6 6 6 6 Configuring NIBP Measurement Modes 6 7 6 6 1 Setting the Automatic Mode 6 7 6 6 2 Setting the Sequence Mode 6 7 6 6 3 Setti...

Страница 9: ...cting Agents 9 3 9 3 2 Cleaning the Equipment 9 5 9 3 3 Disinfecting the Equipment 9 5 9 4 Cleaning and Disinfecting the Reusable NIBP Cuff 9 6 9 5 Sterilization 9 6 10 Maintenance 10 1 10 1 Introduct...

Страница 10: ...Physical Specifications A 4 A 4 1 BP10 A 4 A 5 Hardware Specifications A 4 A 5 1 BP10 A 4 A 5 2 Central Charger A 4 A 6 MPAN Specifications A 5 A 6 1 Technique Specification A 5 A 6 2 Wireless Functio...

Страница 11: ...BP10 Operator s Manual 1 1 1 Safety Safety Information 1 2 Equipment Symbols 1 5...

Страница 12: ...e 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 prop...

Страница 13: ...and authorized personnel The physiological data displayed on the system are for reference only and cannot be directly used for diagnostic interpretation Only use parts and accessories specified in thi...

Страница 14: ...other equipment could result 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 to prevent...

Страница 15: ...mitation Atmospheric pressure limitation Plastics identification symbol Dispose of in accordance to your country s requirements This product bears CE mark indicating its conformity with the provisions...

Страница 16: ...Equipment Symbols Safety 1 6 BP10 Operator s Manual This page intentionally left blank...

Страница 17: ...BP10 Operator s Manual 2 1 2 General Product Description Intended Use 2 2 Applied Parts 2 2 Major Features 2 2 Physical Views 2 3 Main Screen 2 5...

Страница 18: ...igned for monitoring critically ill patients If the accuracy of any value displayed at BP10 is questionable determine the patient s vital signs by alternative means and verify that BP10 is working cor...

Страница 19: ...menu 4 NIBP start stop key When NIBP is in process press this key to stop the NIBP measurement When NIBP is idle press this key to start an NIBP measurement 5 Down key Press this key to move down alo...

Страница 20: ...this key to display the power off confirmation menu If the screen display is on press this key to turn the display off 9 MPAN key When BP10 is disconnected from the MPAN press this key to begin the b...

Страница 21: ...ymbol displays when the MPAN is turned on 6 Battery symbol This symbol indicates the battery charge status Refer to Checking the Battery Charge Status on page 8 3 for additional information 7 Operatio...

Страница 22: ...econds elapses after an NIBP measurement ends this area automatically displays the measurement list 9 Message area The message area shares the same position as patient category and operation mode This...

Страница 23: ...Operator s Manual 3 1 3 Getting Started Safety 3 2 Unpacking and Checking 3 3 Environmental Requirements 3 3 Installing the Batteries 3 4 Powering On the Device 3 6 Basic Operations 3 6 Using the Pouc...

Страница 24: ...dical electrical equipment The system configuration must meet the requirements of the IEC 60601 1 medical electrical systems standard Any personnel who connect devices to the equipment s signal input...

Страница 25: ...can be used if the device must be reshipped 3 3 Environmental Requirements The operating environment of the device must meet the requirements specified in this manual The device operating environment...

Страница 26: ...performance NOTE Always keep the battery compartment dry Never use brute force to install the lithium ion battery pack or AA battery frame Otherwise the waterproof ring surrounding the battery frame e...

Страница 27: ...ed tab on the upper part of the lithium ion battery pack with the cutout in the base of the battery compartment as indicated in Figure 3 2 Figure 3 2 Align the Raised Tab on Battery Pack 4 Press down...

Страница 28: ...maintenance passcode service passcode for the first time startup If BP10 is turned on next time the device will directly go to the main screen WARNING Do not use the equipment for any NIBP measuremen...

Страница 29: ...option in a menu follow this procedure 1 Use the and keys to move the highlighted bar to an appropriate position 2 Press the key to select the option where the highlighted bar locates Controls Descrip...

Страница 30: ...exit the menu 3 6 3 Turning the Display Off You can manually turn the display off or let the display automatically turn off based on the configured timeout Press the key to manually turn the display...

Страница 31: ...nap fastener to close the pouch 3 Secure the pouch on the patient with ties around the patient s shoulder and under the arm as shown in Figure 3 6 and Figure 3 7 4 Apply the cuff and hose You can plac...

Страница 32: ...Using the Pouch Getting Started 3 10 BP10 Operator s Manual NOTE The pouch is used only for BP10 The pouch cannot be used for carrying other personal devices such as a mobile phone...

Страница 33: ...troduction 4 2 Configuring the Display 4 2 Switching On Off the Audio 4 2 Turning On Off MPAN 4 4 Setting Time and Date 4 4 Changing Language 4 4 Changing the Passcode 4 5 Changing the Device Name 4 5...

Страница 34: ...e the setting 6 Press the key to exit the menu 4 2 2 Configuring the Display Auto Off You can configure the display to automatically turn off when the configured time is reached 1 Enter the main menu...

Страница 35: ...ame function as this menu option Refer to Physical Views on page 2 3 for the hard key function 4 5 Setting Time and Date To set the time and date follow this procedure 1 Enter the main menu 2 Select S...

Страница 36: ...e follow this procedure 1 In the main menu select System 2 Select Maintenance and enter the maintenance passcode 3 In the Maintenance menu select Edit Passcodes Select Maintenance Passcode and follow...

Страница 37: ...onfigurations to factory defaults To restore the factory defaults follow this procedure 1 In the main menu select System 2 Select Maintenance and enter the maintenance passcode 3 In the Maintenance me...

Страница 38: ...Service Menu Configuring BP10 4 6 BP10 Operator s Manual This page intentionally left blank...

Страница 39: ...BP10 Operator s Manual 5 1 5 Patient Management Introduction 5 2 Changing the Patient Category 5 2 Placing a Device in Standby 5 2 Exiting the Standby Mode 5 2 Discharging the Patient 5 3...

Страница 40: ...atient Info menu select Patient Category to select the desired patient category The screen displays the Are you sure you want to change patient category message 3 Select Yes to confirm the change The...

Страница 41: ...as the follows NIBP measurement does not automatically start Resume the ability to provide the technical messages 5 5 Discharging the Patient Discharging the patient will stop monitoring patient and...

Страница 42: ...Discharging the Patient Patient Management 5 4 BP10 Operator s Manual This page intentionally left blank...

Страница 43: ...ment Limitations 6 4 Measuring NIBP 6 4 Configuring the NIBP Setup 6 5 Configuring NIBP Measurement Modes 6 7 Starting and Stopping Measurement 6 9 Understanding the NIBP Display 6 9 Correcting the Me...

Страница 44: ...the cuff The oscillation with the greatest amplitude is the mean pressure This is the most accurate parameter measured by the oscillometric method Once the mean pressure is determined the systolic and...

Страница 45: ...cuff applies pressure on the application site The clinician determines if NIBP measurement is suitable for the patient Continuous non invasive blood pressure measurements may cause purpura ischemia an...

Страница 46: ...he effectiveness of this sphygmomanometer has not been established in pregnant including pre eclamptic patients 6 4 Measuring NIBP 6 4 1 Preparing the Patient In order to minimize the NIBP measurement...

Страница 47: ...cumference or 2 3 of the upper arm s length The inflatable part of the cuff should be long enough to encircle at least 50 to 80 of the limb 6 Apply the cuff to the patient s upper arm at the same leve...

Страница 48: ...140 mmHg The factory default settings are in bold Options Description How to Enter Settings NIBP Timeout Configures the retention time of the measurement value each time it is obtained If OFF is selec...

Страница 49: ...he automatic mode follow this procedure 1 In the main menu select Mode and set it to Auto 2 Select Interval and select the appropriate period The default setting is 15 min 6 6 2 Setting the Sequence M...

Страница 50: ...day is 6 00 and the interval is 15 min The default start time of the night is 22 00 and the interval is 30 min 6 6 4 About Continuous Mode In the continuous mode the measurements are taken one after a...

Страница 51: ...asurement Press the key Automatic Sequence or ABPM modes Start the series measurements in automatic sequence or ABPM mode Press the key Stop current measurement in automatic sequence or ABPM mode Pres...

Страница 52: ...ub diastolic pressure to block the venous blood vessel and therefore help the venous puncture To enable the venous puncture follow this procedure 1 In the Menu screen select Venipuncture 2 Verify the...

Страница 53: ...BP10 Operator s Manual 7 1 7 Connection with External Systems Pairing with a TD60 TM80 7 2 Connecting with Central Monitoring System 7 2...

Страница 54: ...tient by pressing the key at BP10 Always discharge the patient before BP10 is used on the new patient Always make sure that BP10 is applied on the correct patient If BP10 is paired with a TD60 TM80 th...

Страница 55: ...ty 8 2 Installing the Battery 8 3 Checking the Battery Charge Status 8 3 Removing the Battery 8 3 Charging the Rechargeable Lithium ion Battery 8 4 Storing the Batteries 8 5 Maintaining the Rechargeab...

Страница 56: ...pecified lithium ion battery can give unacceptable performance Use caution when handling the rechargeable lithium ion battery Misuse or abuse may cause bodily injury or device damage Do not short circ...

Страница 57: ...attery s useful life to prevent leakage In case of battery leakage use caution to remove the batteries and clean the battery compartment Install fresh AA batteries and check if BP10 can power on prope...

Страница 58: ...the approved power cord with the grounded mains plug to firmly connect the central charger to a grounded AC mains socket Never refit the mains plug to fit an ungrounded AC mains socket Do not use the...

Страница 59: ...e the batteries in a cool dry place ideally at 15 C or 60 F with a partial charge of about 50 capacity two LEDs illuminated Storing batteries in a cool place can slow the aging process Stored batterie...

Страница 60: ...indicates that the incidence of failure may increase with battery service life due to the accumulated stresses of daily use Therefore Mindray strongly recommends that lithium ion battery should be rep...

Страница 61: ...he lithium ion battery in the following situations The battery has visual signs of damage The battery fails The battery is aged and its runtime significantly less than the specification The battery ha...

Страница 62: ...Disposing of the Batteries Battery 8 8 BP10 Operator s Manual This page intentionally left blank...

Страница 63: ...BP10 Operator s Manual 9 1 9 Cleaning and Disinfecting Introduction 9 2 Safety 9 2 Cleaning and Disinfecting the Equipment 9 3 Cleaning and Disinfecting the Reusable NIBP Cuff 9 6 Sterilization 9 6...

Страница 64: ...cal equipment at the same time Some examples of non medical equipment are laser printers and nonmedical computers Avoid use of cleaners materials or chemicals that may damage device surfaces labels or...

Страница 65: ...benzyl ammonium chloride 0 28 Isopropanol 17 2 Virex II 256 Didecyl dimethyl ammonium chloride 8 704 n Alkydimethyl benzyl ammonium chloride 8 190 Virex TB n Alkyl dimethyl benzyl ammonium chlorides...

Страница 66: ...th HB Germicidal Disposable Wipe n Alkyl dimethyl ethylbenzyl ammonium chlorides 0 07 n Alkyl dimethyl benzyl ammonium chlorides 0 07 PDI Sani Cloth Plus Germicidal Disposable Cloth n Alkyl dimethyl e...

Страница 67: ...ipment follow this procedure 1 Shut down the device 2 Clean the display screen with wipes or a soft cloth moistened with one of the cleaning agents listed in Approved Cleaning and Disinfecting Agents...

Страница 68: ...le NIBP Cuff To clean and disinfect the reusable NIBP cuff refer to the instructions for use delivered with the accessory 9 5 Sterilization Sterilization is not recommended for this equipment related...

Страница 69: ...tenance Introduction 10 2 Safety 10 2 Regular Check 10 3 Battery Check 10 3 Maintenance and Testing Schedule 10 4 Power On Test 10 4 Checking the Device Information 10 4 NIBP Leakage and Pressure Test...

Страница 70: ...of this equipment to implement a satisfactory maintenance schedule may cause undue equipment failure and possible health hazards The safety checks or maintenance involving any disassembly of the equi...

Страница 71: ...rmed by qualified service personnel to ensure the reliability Follow these guidelines when inspecting the device Make sure that the environment and power supply meet the requirements Inspect the devic...

Страница 72: ...tests checks the integrity of the system and of the valve Contact your service personnel to perform NIBP leakage and pressure test 10 9 Electrical Safety Test The electrical safety test aims to detect...

Страница 73: ...BP10 Operator s Manual 11 1 11 Accessories NIBP Accessories 11 2 Miscellaneous 11 3...

Страница 74: ...any sign of damage Do not use them if any damage is detected Use the accessories before the expiry date if indicated The disposable accessories shall be disposed of according to the hospital s regulat...

Страница 75: ...ff MW Large Adult Part Number Description Applicable patient Part Number Description 115 026852 00 Main unit of the charger 115 035534 00 BP10 Li ion battery Package 045 001700 00 BP 2AA battery frame...

Страница 76: ...Miscellaneous Accessories 11 4 BP10 Operator s Manual This page intentionally left blank...

Страница 77: ...BP10 Operator s Manual 12 1 12 Troubleshooting General Problems 12 2 Technical Messages and Solutions 12 2 Technical Alarms with TD60 TM80 12 4 Physiological Alarms with Central Monitoring System 12 4...

Страница 78: ...e radio range 2 Signal is interrupted 3 The TD60 TM80 is already paired with other BP10 4 After BP10 is paired with TD60 TM80 user turns off and then turns on the MPAN at BP10 or TD60 TM80 Restart the...

Страница 79: ...condition and change the cuff application site If the error persists replace the cuff NIBP Overrange Yes The measured NIBP value is not within the measurement range Contact your service personnel NIB...

Страница 80: ...2 4 Physiological Alarms with Central Monitoring System BP10 does not provide any physiological alarms or messages When BP10 is connected to TD60 TM80 the NIBP parameter measurements at BP10 will send...

Страница 81: ...A Product Specifications Classifications A 2 Environmental Specifications A 2 Power Supply Specifications A 3 Physical Specifications A 4 Hardware Specifications A 4 MPAN Specifications A 5 NIBP Meas...

Страница 82: ...peration Continuous Degree of protection against harmful ingress of water BP10 IP32 Central Charger IPX0 Degree of protection against hazards of explosion Not suitable Equipment not suitable for use i...

Страница 83: ...erating temperature range declared for the unit Safety and authentication for lithium ion battery UL2054 IEC62133 UN38 3 Run time In the condition of turning off the display the batteries perform as f...

Страница 84: ...BP cuff and any other accessories or 202 g with Lithium ion battery without the NIBP cuff and any other accessories Display Screen type Color TFT LCD screen Screen size 2 4 Resolution 320 pixels 240 p...

Страница 85: ...t power transfer power 2 5 mW Data Security Private protocol Data integrity Code error 1 Transmission distance Distinct vision distance between BP10 and TD60 TM80 is greater than or equal to 3 m Syste...

Страница 86: ...Measurement ranges mmHg Systolic Diastolic Mean Adult 25 to 290 10 to 250 15 to 260 Pediatric 25 to 240 10 to 200 15 to 215 Accuracy Maximum mean error 5 mmHg Maximum standard deviation 8 mmHg Resolut...

Страница 87: ...BP10 Operator s Manual B 1 B EMC...

Страница 88: ...rify normal operation in the configuration in which it will be used The device needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information p...

Страница 89: ...Operating mode Accuracy Function Accessories identification Data stored Detect for connection Guidance and Declaration Electromagnetic Emissions The device is intended for use in the electromagnetic e...

Страница 90: ...typical commercial or hospital environment Surge IEC 61000 4 5 1 kV lines s to line s 2 kV line s to earth Not applicable Voltage dips Short interruptions and voltage variation on power supply input...

Страница 91: ...quency range b Interference may occur in the vicinity of equipment marked with the following symbol Note At 80 MHz to 800 MHz the separation distance for the higher frequency range applies Note These...

Страница 92: ...power of the communications equipment Rated Maximum Output power of Transmitter W Watts Separation Distance According to Frequency of Transmitter M Meters 150kHz 80MHz d 1 2 80MHz to 800MHz d 1 2 800M...

Страница 93: ...BP10 Operator s Manual C 1 C FCC Compliance...

Страница 94: ...accept any interference received including interference that may cause undesired operation Any changes or modifications to this equipment not expressly approved by Mindray may cause harmful radio freq...

Страница 95: ...BP10 Operator s Manual D 1 D Symbols and Abbreviations Units D 2 Symbols D 3 Abbreviations D 3...

Страница 96: ...ter dB decibel DS dyne second F fahrenheit g gram h hour hPa hundred pascal Hz hertz in inch k kilo kg kilogram kPa kilopascal l litre lb pound m meter mg milligrams min minute ml milliliter mm millim...

Страница 97: ...ion for Advancement of Medical Instrumentation AC alternating current ANSI American National Standard Institute CISPR International Special Committee on Radio Interference CMS central monitoring syste...

Страница 98: ...Abbreviations Symbols and Abbreviations D 4 BP10 Operator s Manual P power PR pulse rate...

Страница 99: ......

Страница 100: ...P N 046 011008 00 4 0...

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