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A-8

Shock

Complies with requirements of 21.102, ISO9919:

Peak acceleration: 1000m/s2 (102g)

Duration: 6ms

Pulse shape: half-sine

Number of shocks: 3 shocks per direction per axis (18 total)

Vibration

Complies with requirements of 21.102, ISO9919.

Bump

Complies with the requirements of 6.3.4.2, EN1789.

Peak acceleration: 15g

Duration: 6ms

Number of impacts: 1000

Impact direction: vertical impacts are applied when the equipment under test is placed at normal operating position.

Drop

1.5 m per IEC 68-2-32

Содержание BeneHeart D1

Страница 1: ...BeneHeart D1 Automated External Defibrillator Operator s Manual...

Страница 2: ......

Страница 4: ...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 distri...

Страница 5: ...ance 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 r...

Страница 6: ...an made failure Malfunction or damage caused by unstable or out of range power input Malfunction or damage caused by force majeure such as fire and earthquake Malfunction or damage caused by improper...

Страница 7: ...n 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 clinical professionals wh...

Страница 8: ...VI FOR YOUR NOTES...

Страница 9: ...3 Basic Operations and Settings 3 1 3 1 Installation 3 1 3 1 1 Unpacking and Checking 3 1 3 1 2 Environmental Requirements 3 2 3 1 3 Installing the Battery 3 2 3 1 4 Connecting Electrode Pads 3 2 3 2...

Страница 10: ...n Procedure 6 3 6 5 Synchronized Cardioversion 6 4 6 5 1 Performing Synchronized Cardioversion 6 4 6 5 2 Delivering Additional Synchronized Shocks 6 5 6 5 3 Disabling the Sync Function 6 5 7 Monitorin...

Страница 11: ...Menu For Pro Only 9 4 9 6 7 Test Setup Menu 9 4 9 6 8 Network Setup Menu 9 5 9 6 9 Config Menu 9 5 10 Battery 10 1 10 1 Introduction 10 1 10 2 Battery Alarms 10 2 10 2 1 Low Battery Alarm 10 2 10 2 2...

Страница 12: ...2 A 3 Monitor Specifications A 4 A 4 Power Supply Specifications A 6 A 5 Alarm Specifications A 7 A 6 Data Management Specifications A 7 A 7 Wireless Network A 7 A 8 Environmental Specifications A 7...

Страница 13: ...ng Instructions this electrical energy may cause serious injury or death Do not attempt to operate this defibrillator unless thoroughly familiar with these operating instructions and the function of a...

Страница 14: ...or safe patient monitoring Do not perform any functional check if the equipment is connected with a patient otherwise the patient might be shocked Remain attentive to the patient during applying thera...

Страница 15: ...emit higher levels of electromagnetic radiation Always install or carry the equipment properly to avoid damage caused by drop impact strong vibration or other mechanical force Dry the equipment immedi...

Страница 16: ...ns General symbol for recovery recyclable Do not expose the battery to high heat or open flames Do not incinerate the battery Do not crush the battery Do not mutilate the battery or open the battery c...

Страница 17: ...nual Defib mode adjust the energy level if necessary 2 Charge and 3 Deliver the shock Defibrillation is performed through multifunction electrode pads In Manual Defib mode you can also perform synchro...

Страница 18: ...for ventricular fibrillation and ventricular tachycardia in patients that are pulseless and unresponsive Synchronous defibrillation is intended for termination of atrial fibrillation 2 2 3 ECG The EC...

Страница 19: ...diately above The labels of the soft keys change according to the current operating mode For Pro there are five soft keys while for Public there are three 5 Shock button Press this button to deliver a...

Страница 20: ...2 4 2 3 3 Rear View 1 Pads compartment 2 Battery compartment 3 Release button Press down this button and slide the battery door to the right to open the battery compartment 1 2 3...

Страница 21: ...Alarm status symbols indicates alarm sounds are paused indicates alarm sounds are turned off 2 Alarm area This area shows alarm messages When multiple alarms occur they will be displayed circularly 1...

Страница 22: ...view and function Soft key labels appearing as blank indicate that the soft key is inactive 2 5 Soft Key Symbols Below is the description of symbols displayed in the soft key label area Return to the...

Страница 23: ...dent from the equipment specifications whether a particular combination is hazardous for example due to summation of leakage currents consult the manufacturers or else an expert in the field to ensure...

Страница 24: ...the system before the condensation disappears NOTE Make sure that the operating environment of the equipment meets the specific requirements Otherwise unexpected consequences e g damage to the equipm...

Страница 25: ...ress the Power ON OFF button and the Select an option window is displayed Then select Config Config Edit enter the required password General Setup If the equipment is off For Pro press the Power ON OF...

Страница 26: ...Disconnect the patient cables and sensors from the patient 3 Press the Power ON OFF button and the Select an option window is displayed 4 Press the soft key to shut down the equipment 3 2 4 Auto Rest...

Страница 27: ...physiological and technical alarms the equipment also shows some messages indicating system status Technically prompt messages are not alarm messages Messages of this kind are usually displayed in co...

Страница 28: ...hysiological alarms the asterisk symbols before the alarm message match the alarm level as follows High level alarms Medium level alarms Low level alarms Additionally the alarm message has different b...

Страница 29: ...d temporarily In the audio paused status all alarm indicators except audible alarm tones works properly You can press Silence again to restore alarm sounds If new alarms are triggered alarm sounds res...

Страница 30: ...indications are cleared after Silence soft key is pressed After the equipment restores the normal alarm status it can give alarm indications correctly in case these alarms are triggered again For othe...

Страница 31: ...pment connected to the patient including the bed or gurney during defibrillation Avoid contact between parts of the patient s body such as exposed skin of head or limbs conductive fluids such as gel b...

Страница 32: ...be impaired NOTE If needed perform CPR when there is delay or interruption in using of the equipment 5 3 AED View A typical screen in AED Mode is shown below For Pro For Public In AED mode the informa...

Страница 33: ...hen starts CPR or resume rhythm analysis according to the current NSA Action setting 5 Press the Shock button if prompted Make sure no one is touching the patient bed or any equipment connected to the...

Страница 34: ...y The degree of impedance differs from patient to patient and is affected by several factors including the presence of chest hair moisture and lotions or powders on the skin If the Impedance too high...

Страница 35: ...n Config Edit menu In CPR mode voice instructions pictures and prompt messages needed for CPR are provided After the shock series ECG analysis pauses and the equipment enters the CPR status Analysis r...

Страница 36: ...assword 2 Select General Setup Voice Recording and toggle between On and Off The symbol is shown at the top right corner of the screen if the sounding recording function is enabled The equipment can s...

Страница 37: ...metal objects such as a bed frame or a stretcher which may provide unwanted pathways for the defibrillating current Do not allow multifunction electrode pads to touch each other or to touch other ECG...

Страница 38: ...hange the pads 6 3 Manual Defibrillation View A typical screen in Manual Defib mode is shown below In manual defibrillation mode an ECG waveform and related parameters are displayed In the middle of t...

Страница 39: ...n shock You can accelerate the selection by pressing and holding either of the buttons 6 Press Charge soft key to charge As the equipment charges a progress bar is shown in the defibrillation informat...

Страница 40: ...ng to 7 Monitoring ECG 2 In Manual Defib mode press the and then Enter Sync soft keys to activate the synchronous cardioversion function 3 Press the and then Lead soft keys to select a lead The select...

Страница 41: ...itional synchronized shocks are indicated perform the following steps 1 Make sure the equipment is still in Sync mode as indicated by the presence of the Sync message in the defibrillation information...

Страница 42: ...6 6 FOR YOUR NOTES...

Страница 43: ...g a patient implanted with a pacemaker do not completely rely on the heart rate reading or the heart rate alarms Always keep paced patients under close surveillance NOTE If the correct electrodes are...

Страница 44: ...rub skin surface at application sites to remove dead skin cells Thoroughly clean the sites with mild soap and water We do not recommend using ether or pure alcohol because this dries the skin and incr...

Страница 45: ...and its grounding plate to prevent unwanted burns Never entangle ESU cable and ECG cable together When using electrosurgical units ESU never place ECG electrodes near to the grounding plate of the ESU...

Страница 46: ...mely Auto 0 125 0 25 0 5 1 2 and 4 When Gain is set to Auto the system selects the most appropriate gain for the current waveform 7 5 3 Choosing AHA or IEC Lead Placement 1 Press the Power On Off butt...

Страница 47: ...Vtac PVCs limit and the HR the Vtac rate limit Vent Brady The consecutive PVCs the Vbrd threshold and the ventricular HR the Vbrd Rate threshold Extreme Tachy The heart rate is equal to or greater tha...

Страница 48: ...events 7 6 3 Changing Arrhythmia Threshold Settings 1 Press the Power On Off button and then select Config Config Edit enter the required password 2 In the Config Edit menu select ECG Setup and then c...

Страница 49: ...or lead label is changed The ECG lead is re connected Patient category is changed The paced status is changed Arrhythmia analysis is switched on Stop Calibrating is selected after ECG calibration is c...

Страница 50: ...7 8 FOR YOUR NOTES...

Страница 51: ...device ID software version hardware version work status and battery information The data management function enables you to export the following patient data on the equipment to a USB flash memory La...

Страница 52: ...h memory after the data has been exported CAUTION To avoid shock hazard do not connect the USB flash memory unless you are to export data Remove it timely once finished NOTE If Delete Data After Expor...

Страница 53: ...System Configuration When the equipment is on press the Power On Off button and then select Config View Config to view the current system configuration 9 3 Password Accessing configuration management...

Страница 54: ...es to restore all the current settings to factory default settings WARNING The system date time and language settings in General Setup menu and all the settings in Network Setup remain unchanged after...

Страница 55: ...Remark Shock Series 1 2 3 1 Energy 1 Adult 100 150 170 200 300 360J 200 J Energy 2 Pediatric 10 15 20 30 50 70 100J 50J Energy 2 Adult Energy 1 to 360J 300 J Cannot be less than Energy 1 Pediatric En...

Страница 56: ...Pediatric 15 to 120 50 Vbrd Rate 15 to 60 40 Vbrd PVCs 3 to 99 5 V Tach Rate 100 to 200 130 V tach PVCs 3 to 99 6 Tachy Adult 60 to 300 120 Pediatric 60 to 300 160 Brady Adult 15 to 120 50 Pediatric...

Страница 57: ...ystem Site 4 segments and editable range 0 to 255 for each Input the IP address of Device Management System Network Test Used to test the configured network and display related connection information...

Страница 58: ...9 6 FOR YOUR NOTES...

Страница 59: ...eplaced immediately You can check the status of rechargeable battery by pressing the fuel gauge button on the battery to illuminate the battery gauge The fuel gauge consisting of 5 LEDs each LED repre...

Страница 60: ...aken in 3 minutes NOTE The Low Battery alarm means that the battery is beginning to weaken and should be replaced at the first opportunity At least 20 minutes of monitoring and 10 200J shocks can be p...

Страница 61: ...hear it click into the place NOTE Check the expiration date displayed on the disposable battery Remove from use if the battery is expired Never remove the battery unless the equipment indicates to do...

Страница 62: ...side the range of 20 C 4 F to 60 C 140 F NOTE Storing batteries at temperature above 38 C 100 F for an extended period of time significantly shorten the life expectancy of a battery 10 6 Recycling the...

Страница 63: ...ns for use of corresponding accessories 11 1 General Points Keep you equipment and accessories free of dust and dirt To avoid damage to the equipment follow these rules Always dilute according the man...

Страница 64: ...equipment disconnect cables and remove the battery 2 Clean the display screen using a soft clean cloth dampened with a glass cleaner 3 Clean the exterior surface of the equipment using a soft clean c...

Страница 65: ...Select an option window is displayed If the equipment is off For Pro press the Power ON OFF button the third and fourth soft keys from left to right simultaneously While for Public press the Power ON...

Страница 66: ...d Inspection Test item After each use Daily Weekly Monthly Make sure that the status indicator is green Check the status of the equipment and accessories Perform user test Replace pads Check the expir...

Страница 67: ...have heard the voice prompt Other items are tested hereafter automatically If all items pass the test the test result is Test Passed If any failure is detected corresponding prompts and failure codes...

Страница 68: ...ck button as indicated on the screen 2 Select an option to respond to the equipment if you have heard the voice prompt Other items are tested hereafter automatically If all items pass the test the tes...

Страница 69: ...Call for service No alarm sound The audio alarm is disabled Select Config Config Edit enter the required password Alarm Setup Then set Alm Volume to Low or High Equipment malfunction Call for service...

Страница 70: ...larm messages are displayed exclusively That is to say when an exclusive physiological alarm and normal high level physiological alarms are triggered simultaneously only alarm message of the exclusive...

Страница 71: ...B Battery Err High B There is a problem with the battery Check the battery for damage verify that correct battery is used Replace the battery if necessary Battery Aged Low B Rechargeable battery is ag...

Страница 72: ...re expiring soon Replace the pads timely Load Config Err Low A An error occurred when loading configuration file Reconfigure the equipment If the changes cannot be saved call for service Operation Mod...

Страница 73: ...ing temperature Refer to corresponding accessory s instrution for use for details 14 1 ECG Accessories 12 pin Trunk Cable Leadwire supported Model Compatible with Type Applicable patient PN 3 lead EV...

Страница 74: ...hium ion battery LI24I001A 022 000047 00 Disposable battery LM34S001A 022 000124 00 Charger Station kit with international power cord BatteryFeed 20 115 009187 00 Charger Station kit with US power cor...

Страница 75: ...on against harmful ingress of solid IP5X Degree of protection against harmful ingress of water IPX5 Degree of mobility Portable Size Width depth height 288 211 79 5 mm Weight Main Unit 2 3 kg without...

Страница 76: ...m auto compensation according to patient impedance Defibrillation electrodes Multifunction electrode pads Range of selected energy External defibrillation 1 2 3 4 5 6 7 8 9 10 15 20 30 50 70 100 150 1...

Страница 77: ...97 100 97 93 89 85 81 15 150 J 146 150 146 140 134 128 122 15 170 J 166 170 166 159 151 145 138 15 200 J 195 200 195 187 178 170 163 15 300 J 292 300 292 280 267 255 244 15 360 J 351 360 350 336 321...

Страница 78: ...r non shockable rhythms Specificity 95 Meets IEC 60601 2 4 and AAMI DF80 requirement and AHA recommendation A 3 Monitor Specifications ECG Patient connection 3 lead ECG cable or multifunction electrod...

Страница 79: ...0 1 bpm 120 1 bpm 90 2 bpm Response to change in heart rate Meets requirements of ANSI AAMI EC13 2002 section 4 1 2 1 f From 80 to 120 bpm less than 11 s From 80 to 40 bpm less than 11 s Time to alarm...

Страница 80: ...uge 5 LEDs indicating the current battery charge level Remaining charge after Low Battery is reported At least 20 minutes of ECG monitoring under the work condition of low LCD brightness with wireless...

Страница 81: ...x 180 minutes in total Data export Data can be exported to a PC through a USB flash memory A 7 Wireless Network Standard IEEE 802 11 b g Operating Frequency band MHz 2412 to 2472 Transmitter Out Power...

Страница 82: ...cks per direction per axis 18 total Vibration Complies with requirements of 21 102 ISO9919 Bump Complies with the requirements of 6 3 4 2 EN1789 Peak acceleration 15g Duration 6ms Number of impacts 10...

Страница 83: ...ectromagnetic environment specified below The customer or the user of the equipment should assure that it is used in such an environment Emission test Compliance Electromagnetic environment guidance R...

Страница 84: ...r frequency range applies Note 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a The ISM indu...

Страница 85: ...ansmitter in watts W according to the transmitter manufacturer Note 1 At 80 MHz and 800 MHz the higher frequency range applies Note 2 The ISM industrial scientific and medical bands between 150 kHz an...

Страница 86: ...B 4 FOR YOUR NOTES...

Страница 87: ...he problem if there is any abnormity Equipment Name Serial Number Department Item Requirements Pass Fail Description of Abnormity Equipment Accessory appearance Clean no foreign substance no crack Bat...

Страница 88: ...C 2 FOR YOUR NOTES...

Страница 89: ...Detected Shock Advised Charging to sJ Shock Advised Charging Charge Failed Charge Failed Do Not Touch Patient Press Shock Button Do Not Touch the Patient Press the Shock Button Shock Delivered Shock...

Страница 90: ...harge Removed Shock Button Not Pressed Charge Removed Disarming Failed Maintenance User test Normal Error Please Perform User Test to Confirm Rechargeable Normal Rechargeable Aged Replace Battery Advi...

Страница 91: ...ork and setup Cannot Reach the Site Check the site and setup Are you sure to restore to factory default All settings restored to factory default Config file not found Are you sure to import the file a...

Страница 92: ...D 4 FOR YOUR NOTES...

Страница 93: ...Power Cord Plug Test Item Acceptance Criteria The power plug The power plug pins No broken or bent pin No discolored pins The plug body No physical damage to the plug body The strain relief No physic...

Страница 94: ...on normal polarity with open earth Single Fault Condition reverse polarity with open earth Single Fault Condition LIMITS For CF applied parts 10 A in Normal Condition 50 A in Single Fault Condition Fo...

Страница 95: ...ormal Condition reverse polarity Normal Condition normal polarity with open neutral Single Fault Condition reverse polarity with open neutral Single Fault Condition normal polarity with open earth Sin...

Страница 96: ...E 4 FOR YOUR NOTES...

Страница 97: ...ere hour bpm beat per minute bps bit per second C centigrade cm centimeter dB decibel F fahrenheit h hour Hz hertz in inch J Joule kg kilogram kPa kilopascal L litre m meter min minute mm millimeter m...

Страница 98: ...al Standard Institute aVF left foot augmented lead aVL left arm augmented lead aVR right arm augmented lead CE Conformit Europ enne CISPR International Special Committee on Radio Interference CPR Card...

Страница 99: ...g MRI magnetic resonance imaging Neo neonate O2 oxygen Ped pediatric PNC pacer not captured PNP pacer not paced PVC premature ventricular complex RA right arm Rec record recording RL right leg Sync sy...

Страница 100: ...F 4 FOR YOUR NOTES...

Страница 101: ...e we are going to track our product Please contact us with the device tracking information when you have received your defibrillator monitor Please fill the information in the next page cut the table...

Страница 102: ...G 2 FOR YOUR NOTES...

Страница 103: ...g Information User Information Customer Name Department name Address City State Zip Post Code Country Contact Person Tel No Fax No Email Address Device Information Product name Serial number Model Ins...

Страница 104: ......

Страница 105: ......

Страница 106: ...P N 046 004673 00 3 0...

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