Mindray BP10 NIBP Module Operator'S Manual Download Page 94 | Manualshive

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FCC Compliance

C - 2

BP10 Operator’s Manual

This device complies with Part 15 of the FCC Rules. Operation is subject to the following
two conditions: (1) this device may not cause harmful interference, and (2) this device
must 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 frequency interference and void your authority to operate this
equipment.

RF Parameter (Panlink2 Module)

Type of Radio

Bluetooth Low Energy 4.0

Operating Frequency

2402 MHz to 2480 MHz

Modulation Mode

GFSK

Output Power

≤2.5mW

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Summary of Contents for BP10 NIBP Module

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

Page 2: ......

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

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

Page 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...

Page 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...

Page 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...

Page 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...

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

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

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

Page 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...

Page 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...

Page 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...

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

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

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

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

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

Page 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...

Page 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...

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

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

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

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

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

Page 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...

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

Page 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...

Page 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...

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

Page 99: ......

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

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