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Biolight Meditech M850 Manual

Patient monitor
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Product Information
Product Model: M850
Product Name: Patient monitor
Manufacturer: Guangdong Biolight Meditech Co., Ltd.
After Service Contact Information:
Address:
No.2
Innovation Coast, Hi-tech Zone, Zhuhai ,
P.R.China
Fax: +86-756-3399919
Postcode: 519085
Toll-free consultation hot line: +86-400-8818-233
Revision History
This manual has a revision number. This revision
number changes whenever the manual is updated due to
software or technical specification change. Contents of this
manual are subject to change without prior notice.
Document No.: J/M850-I-002
Revision number: V1.0
Release time: Oct.2016
Copyright © 2016 Guangdong Biolight Meditech Co., Ltd.
All rights reserved.
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  • Page 1 Contents of this manual are subject to change without prior notice. Document No.: J/M850-I-002 Revision number: V1.0 Release time: Oct.2016 Copyright © 2016 Guangdong Biolight Meditech Co., Ltd. All rights reserved.
  • Page 2 Statement Manufacturer holds the copyright of this manual, and we are also entitled to deal with this manual as confidential files. This manual is only used for operation, maintenance and service of product, someone else can not publish the manual. This manual contains exclusive information protected by copyright laws and we reserve its copyright.
  • Page 3 About this manual 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.
  • Page 4 Signs in this manual: Warning: Indicates a potential hazard or unsafe practice that, if not avoided, will 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.

  • Page 5: Table Of Contents

    Contents   Chapter 1 General Introduction ........... 1-1     Intended Use .............. 1-1     Main Unit ..............1-1     Display Views ............1-6   Chapter 2 Safety ..............2-1     Safety Information ............. 2-1     Explanation of Symbols ..........
  • Page 6     Alarm Levels ............. 4-2     Alarm Indicators ............4-3     Alarm Status Symbol ..........4-6     Alarm Tone Configuration ........4-7     Pausing Alarms ............4-7     Shutting off the Alarm Volume ........4-8  ...
  • Page 7     Monitoring Procedure ..........7-4     SpO2 Display ............. 7-5     PR Display ..............7-6     SpO2 Setup ..............7-7     Desat limit Setup ............7-8   Chapter 8 Trend Review ............8-1     Introduction ...............
  • Page 8   Appendix A Product Specifications ......... 1   A.1 Safety Specifications ............. 1   A.2 Physical Specifications ..........2   A.3 Environmental Specifications........2   A.4 Charging Specifications ..........2   A.5 Hardware Specifications ..........3   A.6 Data Storage ..............4  ...

  • Page 9: Chapter 1 General Introduction

    Patient Monitor User’s Manual Chapter 1 General Introduction 1.1 Intended Use M850 Patient monitor is intended for continuously monitoring or spot checking of SpO , PR, ECG, HR and RR signals of single adult, pediatric and neonatal patient. This device can be used in institutions or units with health care capability.
  • Page 10 Pati ient Monitor User’s Manual Fig 1- -1 Front View of the Monitor Alarm indicat ing lamp When an alar rm occurs, this lamp will light up as defined below: High level ala arm: the lamp quickly flashes red. Medium level l alarm: the lamp slowly flashes ye ellow.
  • Page 11 Patient Monitor User’s Manual Alarm pause button It can pause the alarm for 120s when alarm volume is on. Pressing it can change the alarm message to prompt message when “Lead off” or “Sensor off” alarm happens. Main interface button Press this button to return to main interface when it is on menu setting.
  • Page 12 Pati ient Monitor User’s Manual Fig 1- -2 Rear View of the Monitor 1.2.3 Side View Topside:...
  • Page 13 Pati ient Monitor User’s Manual Downside: Rightside: Fig 1 -3 Side View of the Monitor ECG cable co nnector SpO2 probe co onnector Micro USB co onnector Connect with power adapter. Export data to o computer. Shortcut key Press this butt ton to freeze or unfreeze the ECG waveform Power buttom...

  • Page 14: Display Views

    Patient Monitor User’s Manual Press it about two seconds to turn off when the monitor is on the condition of working. Calibration of touch screen Press shortcut key firstly and press power button and immediately loose shortcut key, click the center of appearing point on screen.
  • Page 15 Patient Monitor User’s Manual Fig 1-4 Multi-Parameter Display Mode Patient ID No.: Click and then set patient information, its range from 1 to 96. HR parameter area: The current HR parameter and its high and low alarm limits are shown in the area. Resp waveform area: Resp waveform is shown in the area.
  • Page 16 Patient Monitor User’s Manual area. SpO2 parameter area: The current SpO2 and its high and low alarm limits are shown in the area. SpO2 waveform area: The waveform shown in the area is current SpO volume curve. Physiological alarm area: Current physiological alarm information is shown in the area.
  • Page 17 Patient Monitor User’s Manual 1.3.2 SpO2 Display mode Fig 1-5 SpO2 Display Mode SpO2 waveform area: The waveform shown in the area is current SpO volume curve. parameter area: The values shown in the area are current SpO value and its upper and lower alarm limits. PR parameter area: The values shown in the area are current PR value and its upper and lower alarm limits.
  • Page 18 Patient Monitor User’s Manual 1.3.3 ECG Waveform Display Mode Fig 1-6 ECG Display Mode HR parameter area: The values shown in the area are current HR value and its higher and lower alarm limits. ECG waveform display area: Waveform shown in the area is current ECG waveform.
  • Page 19 Patient Monitor User’s Manual 1.3.4 ECG Waveform Display Mode with RESP Fig 1-7 ECG Display Mode with RESP ECG waveform display area: Waveform shown in the area is current ECG waveform. HR parameter area: The values shown in the area are current HR value and its upper and lower alarm limits.

  • Page 20: Chapter 2 Safety

    Patient Monitor User’s Manual Chapter 2 Safety 2.1 Safety Information Warning: Explosion hazard: Do not use the monitor in the presence of flammable anesthetics mixture with air, oxygen, or hydrogen. When the monitor is in use, there should not be any great power appliances as high voltage cables, X-ray machine, ultrasound equipment and electrizer in use nearby.
  • Page 21 Patient Monitor User’s Manual high-frequency devices, in order to leakage current burns patient. The monitor is not designed for the sterilized room. The monitor should be handled with care so as to avoid shocks and falls. When the monitor is in use, it must be ensured the batteries have sufficient capacity;...
  • Page 22 Patient Monitor User’s Manual The service life of this monitor is five years. At the end of its service life, the product described in this manual, as well as its accessories, must be disposed of in compliance with the guidelines regulating the disposal of such products.
  • Page 23 Patient Monitor User’s Manual unnecessary to use the electrical wires, and the instrument can be switched on directly. The monitor can only monitor one patient at a time. When a defibrillator is applied on a patient, the monitor may have transient disorders in the display of waveforms.

  • Page 24: Explanation Of Symbols

    Pati ient Monitor User’s Manual Explanat tion of Symbols Symbol Symbol Note Type C CF applied part, defibrillation prote ected. The uni it displaying this symbol contains an F-Type isolated d (floating) applied part providin ng a high degree of protection against shock k, and is defibril llator-proof.
  • Page 25 Patient Monitor User’s Manual Date of manufacture Manufacturer Serial number Power button Short for “Electrocardiogram” Short for “Pulse Oxygen Saturation” Warning：the protection against the effects of the discharge of a cardiac defibrillator is dependent upon the appropriated cable Symbol for the marking of electrical and electronics devices according...

  • Page 26: Chapter 3 Basic Operations

    Patient Monitor User’s Manual Chapter 3 Basic Operations 3.1 Unpacking and Checking Open the package. Parts are as follows in the package .Take out the monitor and its accessories. Parts Standard Optional Quantity 3-lead/5-lead √ cable probes √ this User’s manual √...

  • Page 27: Starting The Monitor

    Patient Monitor User’s Manual modules. ——Check for any mechanical damage; ——Check for any incorrect connection of all the external cables and accessories Warning: Warning: If the monitor is mechanically damaged, or if it is not working properly, do not use it for any monitoring procedure on a patient.

  • Page 28: Auto-Rotate Setting

    Patient Monitor User’s Manual choose the low level brightness to save power. Caution: If the monitor is used outdoors or the ambient light is strong, set the screen brightness to a higher level. 3.5 Auto-Rotate Setting 【Menu】→【System】 ，click the right of 【Auto-rotate】 to select 【On】...

  • Page 29: Patient Information Setting

    Patient Monitor User’s Manual 3.7 Patient Information Setting Caution: The alarm limits of different parameters depend on the patient type. If you set patient type incorrectly, the monitor will judge patient condition by current setting, which might be wrong for your patient. Please select patient...

  • Page 30: Language Setting

    Patient Monitor User’s Manual Select 【Menu】 → 【System】 → 【Maintenance】 →enter the required password. Click the right of 【Demo】to turn off. Caution: The Demo mode is for demonstration purpose only. To avoid that the simulated data are mistaken for the monitored patient’s data, you should not enter the Demo mode during a patient is being monitored.

  • Page 31: Restoring The Factory Configuration

    Patient Monitor User’s Manual 3.11 Restoring the Factory Configuration If you have changed the system’s configuration and want to restore the factory configuration, follow this procedure: 1. Select【Menu】→【System】. 2. Select 【 Set to Default】 , popping up a confirming window, select【OK】to restore the factory configuration.

  • Page 32: Chapter 4 Alarm

    Patient Monitor User’s Manual Chapter 4 Alarm Alarm refers to a prompt that is given by the monitor for medical personnel through visual, audible and other means when a vital sign appears abnormal or the monitor occurs technical problem. Note: The monitor generates all the audible and visual alarms through speaker, alarm lamp and screen.

  • Page 33: Alarm Levels

    Patient Monitor User’s Manual physiological alarm area. Technical alarms Technical alarms are triggered by a device malfunction or a patient data distortion due to improper operation or system problems. Technical alarm messages are displayed in the technical alarm area. Prompt messages As a matter of fact, prompt messages are not alarm messages.

  • Page 34: Alarm Indicators

    Patient Monitor User’s Manual Low level alarms Indicate that the patent’s vital signs appear abnormal and an immediate treatment may be required. By severity, the monitor’s technical alarms can be classified into four categories: high level, medium level alarms, low level alarms and prompt message. Caution: The levels of technical alarms are predefined before the monitor leaves the factory and cannot be changed...
  • Page 35 Patient Monitor User’s Manual screen. Flashing numeric: The numeric of parameter in alarm flashes. Caution: For different alarm levels, the alarm lamp, alarm tone and alarm messages presented are different. 4.3.1. Alarm Tone The different level alarms are indicated by the system in following different audio ways: Alarm Audible prompt...
  • Page 36 Patient Monitor User’s Manual Alarm level Visual prompt High Alarm lamp flashes in red with 2 Hz. Medium Alarm lamp flashes in yellow with 0.5 Hz. Alarm lamp lights on in yellow without flashing. Caution: When multiple alarms of different levels occur at the same time, the monitor will select the alarm of highest level give visual and alarm indications.

  • Page 37: Alarm Status Symbol

    Pati ient Monitor User’s Manual Medium leve l alarms: ** Low level ala arms: * The system us ses different background colors for r the alarm message to ma atch the alarm level: High level ala arms: red Medium leve l alarms: yellow Low level ala arms: yellow...

  • Page 38: Pausing Alarms

    Pati ient Monitor User’s Manual 4.5 Alarm Ton ne Configuration The minimum m alarm volume setting. Select 【Menu】 】→【System】→【Maintenanc ce】→enter the required passwor rd, select 【Machine Mainten.】 → → 【Alarm Alm.Vol.】, you can select “ Off, H Setup】→【Min.A High, Mid, Low”.
  • Page 39 Pati ient Monitor User’s Manual cancel the alarm pau using. Press again the button , the alarm pausing can be cance elled by manual operation. 4.7 Shutting o off the Alarm Volume Set the 【Min.A to 【off】 Alm.Vol.】and【Alarm Volume】 to shut off the alarm volume.

  • Page 40: Alarm Reset

    Pati ient Monitor User’s Manual patient moni toring. Adjusting alarm volume e to a low level may re esult in a hazard to the patien nt. Always keep the patie ent under close surveillance. 4.8 Alarm Re Select 【Men nu】→【System】→【Main ntenance】...

  • Page 41: When An Alarm Occurs

    Patient Monitor User’s Manual 4.9 When an Alarm Occurs Note: When an alarm occurs, you should always check the patient’s condition first. Check the alarm message appeared on screen. It is needed to identify the alarm and action appropriately, according to the cause of the alarm.

  • Page 42: Chapter 5 Measuring Ecg

    Patient Monitor User’s Manual Chapter 5 Measuring ECG 5.1 Introduction Before the mechanical contraction, the heart will firstly produce electrization and biological current, which will be conducted to body surface through tissue and humors; the current will present difference in potential in different locations of the body, forming potential difference ECG, also known as body surface ECG or regular ECG, is obtained by recording this changing potential difference to form a dynamic curve.
  • Page 43 Patient Monitor User’s Manual When conducting defibrillation, it is imperative to only use the ECG electrodes and cables specified by manufacturer. Check the ECG cable and its package for any sign of damage before use. Do not use the cable if any damage is detected.

  • Page 44: Monitoring Procedure

    Patient Monitor User’s Manual cable, make sure that the connectors never come into contact with other conductive parts, or with earth. In particular, make sure that all of the ECG electrodes are attached to the patient, to prevent them from contacting conductive parts or earth.
  • Page 45 Patient Monitor User’s Manual Good electrode-to-skin contact is important for a good ECG signal, as the skin is a poor conductor of electricity. It is necessary to deal with the skin properly before placing the electrodes. The steps are shown as follows: Select sites with intact skin, without impairment of any kind.
  • Page 46 Patient Monitor User’s Manual if the electrodes are not electrolyte self-supplied. Connect the cable leads to the electrodes through the buttons of the electrodes. Note: For patients who tremble a lot or patients with especially weak ECG signals, it might be difficult to extract the ECG signals, and it is even more difficult to conduct HR calculation.
  • Page 47 Patient Monitor User’s Manual Electrode Placement 3-Lead Take the AHA standard as an example, when conducting 3-lead ECG monitoring, use 3-lead ECG cable. The three limb-leads of RA, LA and LL as shown in below figure, will be placed on the relevant locations. This connection can establish the lead of I, II, III.
  • Page 48 Patient Monitor User’s Manual be placed on the relevant locations. This connection can establish the lead of I, II, III, aVR, aVL, aVF; according to actual needs, chest lead V can be placed on any of the locations between V , respectively making one lead of V established.
  • Page 49 Pati ient Monitor User’s Manual and the elec ctrotome should be applied as far as possible from m all other electrodes, a distance of at least 15 cm/6 in is recommended. When using g the ESU device, avoid pl acing the electrodes ne ear the ESU grounding pad, otherwise,...

  • Page 50: Checking Paced Status

    Patient Monitor User’s Manual 5.4 Checking Paced Status It is important to set the paced status correctly when you start monitoring ECG. If the【Pace】status has been set to【Yes】, If the system detects paced signal, the symbol “︱” will be marked on the ECG wave.

  • Page 51: Ecg Display

    Patient Monitor User’s Manual related to Ventricular Premature (including PVCs count), and will not conduct ST analysis.    5.5 ECG Display Fig 5-1 ECG Display 1.HR label 2.HR high alarm limit 3.HR value 4.HR low alarm limit 5. ECG waveform 6.Pacemake pulse symbol 7.Scan speed 5-10...
  • Page 52 Pati ient Monitor User’s Manual 5.6 Setting EC Select 【Menu】 】→【ECG Setup】, enter into E ECG setup interface. Fig 5-2 ECG Setup Interface 5.6.1 Setting HR R Alarm Click the right of f 【HR Alm】, you can select “M Mid, High”. 5.6.2 Setting HR R Alarm Limits Click the right o...

  • Page 53: Setting Ecg

    Patient Monitor User’s Manual can set the HR uplimit and downlimit. Attention: The high alarm should greater than the low one. 5.6.3 Setting ECG Scan Speed Select scan speed of ECG waveform. Click the right of 【Speed】, you can select “6.25 mm/s、12.5mm/s, 25 mm/s”. 5.6.4 Setting ECG Gain Select the gain item of ECG waveform.
  • Page 54 Patient Monitor User’s Manual If lead type is 3 lead, you can select “I，II，III”. If lead type is 5 lead, you can select” I，II，III，aVR， aVL，aVF，Vx”. 5.6.7 Setting Lead Layout If lead type is 3 lead, you can select ”Primary Lead”. If lead type is 5 lead, you can select”...

  • Page 55: Chapter 6 Measuring Resp

    Patient Monitor User’s Manual Chapter 6 Measuring RESP 6.1 Principle of Measuring Monitor measures RESP with the method of impedance. When a patient exhales and inhales, changes will take place in the size and shape of the thoracic cavity, causing consequent changes in the impedance between the two electrodes installed at the patient’s chest.
  • Page 56 Patient Monitor User’s Manual the 5-lead ECG cable. So please plug the 5-lead ECG cable into the ECG socket and refer to 5.3 Monitoring Procedure to place the RA and LL leads onto the body of patient. Warning: For the sake of safety, all the leads on the 5-lead ECG cable must be connected to the body of patient.

  • Page 57: Resp Display

    Patient Monitor User’s Manual 6.3 Resp Display Fig 6-1 Resp Display 1. Resp label 2.Resp waveform 3. Resp uplimit value 4. Resp value 5. Resp downlimit value 6. Resp unit 6.4 Resp Setup Select 【Menu】→【Resp Setup】, enter into Resp setup interface.
  • Page 58 Pati ient Monitor User’s Manual Fig 6-2 Resp Setup Interface 6.4.1   Resp Alar m Setup  Click the right of f 【Resp Alm】 , you can select “M Mid, High”. 6.4.2   Resp Alar m Limits Setup  Click the right of f 【Uplimit】 or 【Downlimit】 , y you can set the Resp uplimit and d downlimit.
  • Page 59 Patient Monitor User’s Manual Select scan speed of Resp waveform. Click the right of 【Speed】, you can select “6.25 mm/s,12.5mm/s, 25 mm/s”. 6.4.4   Gain Setup  Select gain of Resp waveform. Click the right of【Gain】, you can select “x0.25 ,x1,x2”. 6.4.5   Resp Lead Setup  Select computing method of Resp lead.

  • Page 60: Chapter 7 Measuring Spo2

    Patient Monitor User’s Manual Chapter 7 Measuring SpO2 7.1 Introduction The measurement of oxygen saturation of arterial blood (also known as pulse oxygen saturation, usually shortened as ) adopts the principles of light spectra and volume tracing. The LED emits lights with two specific wavelengths, which are selectively absorbed oxygenated...

  • Page 61: Safety Information

    Patient Monitor User’s Manual 7.2 Safety Information Warning : Use only SpO2 sensors specified in this manual. Follow the SpO2 sensor’s instructions for use and adhere to all warnings and cautions. When a trend toward patient deoxygenation is indicated, blood samples should be analyzed by a laboratory co-oximeter to completely understand the patient’s conditions.
  • Page 62 Patient Monitor User’s Manual information. Check the SpO2 sensor and its package for any sign of damage before use. Do not use the sensor if any damage is detected. When disposing the disposable SpO2 probe or useless SpO2 probe, please observe all local, state, and federal regulations that relate to the disposal of this products or similar products.

  • Page 63: Monitoring Procedure

    Patient Monitor User’s Manual 7.3 Monitoring Procedure 1. Selecting SpO Sensor Depending on the patient category, weight and application site, you can select the SpO sensor as required. 2. Connecting SpO2 Sensor Plug the SpO sensor cable into the SpO connector on the measurement module.

  • Page 64: Spo2 Display

    Patient Monitor User’s Manual 7.4 SpO2 Display Parameter Display Fig 7-1 SpO Parameter 1. SpO label 2. High alarm limit of SpO 3. Low alarm limit of SpO 4. SpO value 5. SpO unit Waveform Display...

  • Page 65: Pr Display

    Patient Monitor User’s Manual Fig 7-2 SpO Volume Curve 7.5 PR Display Fig 7-3 PR Display 1. PR label 2. High alarm limit of PR 3. Low alarm limit of PR 4. PR value 5. PR unit...

  • Page 66: Spo2 Setup

    Pati ient Monitor User’s Manual Caution: Duri ing the monitoring of HR and PR, displa aying of HR has priority. That is PR will be di isplayed only when there isn’t HR monit oring. 7.6 SpO2 Setu Select 【Menu】 】→【SpO2 Setup】, enter into S SpO2 Setup interface.

  • Page 67: Desat Limit Setup

    Patient Monitor User’s Manual 7.6.1   SpO2 Alarm Setup  Click the right of 【Alarm】 , you can set alarm level of SpO and PR, you can select “Mid, High” 7.6.2   SpO2 Alarm Limits Setup  Click the right of 【Uplimit】 or 【Downlimit】 , you can set the SpO2 uplimit and downlimit.
  • Page 68 Patient Monitor User’s Manual the desat limit, a high physiological alarm will be trigged. Its setting is as follows. 1、 Select 【 Menu】 → 【System】 → 【Maintenance】 , enter the required password. 2、 Select【Machine Mainten】→【SpO2 Setup】→【Desat limit】, click the right of 【Desat limit】to set its value.

  • Page 69: Introduction

    Pati ient Monitor User’s Manual Chapter 8 Tr rend Review 8.1 Introducti Select 【Menu】 】 → 【Trend】 to enter trend reviewin ng window. In the window, you can review ECG, Reap, SpO nd PR data stored before. 8.2 Review In nterface Fig 8-1 Review Interface If the trend date is...
  • Page 70 Pati ient Monitor User’s Manual clicking the【next】or【P Pre.】. 8.3 Review Se etup Click the right of 【ID】to select patient’s ID D, you can review patient’s tren d review by selecting different ID g 8-2 ID Review Interface Click the right of f 【More】...
  • Page 71 Pati ient Monitor User’s Manual Fig 8-3 T The drop-down Window of “Mor re” You can set 【S Save time】, 【Delete】, 【De elete all】, n this interface. 【Transmission】in Save time: To o adjust recording time, you can select1“0s, 30s, 1min, 2 m min, 5min, 10min”.

  • Page 72: Chapter 9 Battery

    Pati ient Monitor User’s Manual Chapter 9 B attery 9.1 Introducti A rechargeable a and maintenance-free battery is de esigned for Patient Monitor, wh hich enables continuous working when AC power off. When r a lithiu um ion battery is used, the ba attery icon indicates the battery status as follows:...

  • Page 73: Charging The Battery

    Patient Monitor User’s Manual 9.2 Charging the Battery To charge the battery: Connect the Micro USB in power adapter, Connect the other connector of Micro USB in the monitor, and plug the adapter into the AC mains, The indicating lamp on the monitor is on to indicate that the battery is in charge, When the battery charging indicating lamp on the monitor turns off, the battery is fully charged.

  • Page 74: Checking The Lithium Battery

    Patient Monitor User’s Manual 2. Place the monitor in the charger stand and connect the AC mains. Allow the battery to be charged uninterruptedly for above 4 hours. 3. Remove the AC mains and allow the monitor to run from the battery until it shuts off.

  • Page 75: Disposing Of The Batteries

    Patient Monitor User’s Manual 9.5 Disposing of the Batteries Batteries that are damaged or depleted should be replaced and discarded properly. Dispose of used batteries according to local regulations. Warning: Do not disassemble batteries, or dispose of them in fire, or cause them to short circuit. They may ignite, explode, or leak, causing personal injury.

  • Page 76: Chapter 10 Maintenance And Cleaning

    Patient Monitor User’s Manual Chapter 10 Maintenance and Cleaning 10.1 Introduction Keep your equipment and accessories free of dust and dirt. To avoid damage to the equipment, follow these rules: Always dilute according the manufacturer’s instructions or use lowest possible concentration. Do not immerse part of the equipment in the liquid.

  • Page 77: Seasonal Safety Checking

    Patient Monitor User’s Manual Caution: If you spill liquid into the equipment of accessories, connect you service personal or 10.2 Seasonal Safety Checking Note: To ensure the performance and safety of equipment, it must be checked after using 1 year. When check the equipment, please contact professional technology engineers.
  • Page 78 Patient Monitor User’s Manual functional damage. ② Inspect the safety relevant labels for legibility. ③ Verify that the device functions properly as described in the instructions for use. ④ Test the earth leakage current according IEC 60601-1 Limit: NC 500μA, SFC: 1000μA. ⑤...

  • Page 79: Cleaning The Monitor

    Patient Monitor User’s Manual 10.3 Cleaning the Monitor 1. Common detergent and non-corrosive disinfectant used in hospital can be applied to clean monitor, however you must be aware that many kinds of detergents must be diluted prior to utilization, and please use it according to the instruction of detergent manufacturer.

  • Page 80: Cleaning Ecg Cable

    Patient Monitor User’s Manual 10.4 Cleaning ECG Cable The recommended disinfectors include glutaric dialdehyde solution and 10% decolourant solution. a) Please clean cable prior to sterilization. b) Clean the cable surface with soft cloth bedewed with some fresh water or neutral soapy water. c) Scrub cable with soft cloth bedewed with some disinfector.

  • Page 81: Cleaning Spo2 Sensor

    Patient Monitor User’s Manual 10.5 Cleaning SpO2 Sensor 1. The casing of the sensor and light tube can be cleaned with swab or non-velvet soft cloth dipped with medical alcohol. 2. The sensor cable can be cleaned or sterilized with Hydrogen Peroxide 3% or isopropyl alcohol 70%.

  • Page 82: Chapter 11 Accessories

    Patient Monitor User’s Manual Chapter 11 Accessories Warning: Use only accessories specified in this manual. Using other accessories may cause damage to the monitor. Disposable accessories are designed for single-patient use only. Reuse of them may cause a risk of contamination and affect the measurement accuracy.
  • Page 83 Patient Monitor User’s Manual Type Model 5 lead, IEC 15-048-0004 5 lead, AHA 15-048-0003 usable，adult 15-100-0013 SpO2 sensor usable，pediatric 15-100-0014 usable，neonatal 15-100-0015 11-2...

  • Page 84: Appendix A Product Specifications

    Patient Monitor User’s Manual Appendix A Product Specifications A.1 Safety Specifications CFDA classification CE classification Type of protection against electric II with internal power or shock external power device Degree of protection against electric shock Ordinary equipment, without Degree of protection against protection against hazards of hazards of explosion explosion...

  • Page 85: Physical Specifications

    Patient Monitor User’s Manual A.2 Physical Specifications 350g(full configuration, including the Mainframe weight batteries) Mainframe size 142mm(W)×78mm(H)×36mm(D) A.3 Environmental Specifications Operating: 5℃ to +40℃； Temperature Storage: -20℃ to +55℃； Operating: 860hPa to 1060hPa； Atmospheric pressure Storage: 500hPa to 1060hPa； Operating: 15% to 85%(non condensing) Humidity Storage: 10% to 93%(non condensing) A.4 Charging Specifications...

  • Page 86: Hardware Specifications

    Patient Monitor User’s Manual A4.2 Battery Requirement Type Built-in lithium battery Voltage 3.7V capacity 4800mAH Charging time 3～4h Run time >28h A.5 Hardware Specifications A.5.1 Display Size 4.3inch Resolution 480*272 Touch Resistive touch Autorotation four direction Direction A.5.2 Indicating Lamp Alarm indicating 1(Yellow/Red), on the top of screen.

  • Page 87: Data Storage

    Patient Monitor User’s Manual A.5.3 Audio Indicating  Speaker Gives audible alarm, button tone and QRS tone; Supports Pitch Tone and multi-level volume; Alarm tones meet the requirement of IEC 60601-1-8. Alarm pressure 45 dB to 85 dB, Testing place is 1 meter from the tone.

  • Page 88: Measurement Specifications

    Patient Monitor User’s Manual Patient ID 1～96 Display way Trend tabular trend interval 10s, 30s, 1min, 2min, 5min, 10min Storage Save when power down 500 groups/patient can be stored (only Capacity data, no waveform). A.7 Measurement Specifications A.7.1 ECG Specifications Lead type 3-lead：I,II,III 5-lead：I, II, III, aVR, aVL, aVF, Vx...
  • Page 89 Patient Monitor User’s Manual GMRR ≥89dB Frequency 0.5－40Hz response Electrode offset ±500mV d.c. potential Standardizing 1mV ±5% signal Protection Electric isolation voltage is 4000V at 50/60Hz 60s. Anti-high-frequency interference of electrotome. defibrillator-proof. Electrode off with(except RL) indicating Scan speed 6.25 mm/s,12.5 mm/s, 25 mm/s Pacemaker With pacemaker...
  • Page 90 Patient Monitor User’s Manual Pulse width：0.1~2.0ms Rise time：10~100us Electrosurgery Cut power :300W protection Coagulation power :100W ( electrotome Change of heart rate : ≤10％ protection ) Recover time : ≤10s Comply with the requirement of clause 4.2.9.14 in ANSI/AAMI EC 13:2002 Tall T-Wave Minimum recommended 1.2 mV T-Wave rejection...
  • Page 91 Patient Monitor User’s Manual of HR meter 6s to 10s. to change in HR changes from 80bpm to 40bpm: less than 6s to 10s. Time to alarm Vent Tachycardia 1mVp-p, 206bpm: Gain 0.5, Range 6.5 to 8.4 seconds, Average Tachycardia 7.2 seconds Gain 1.0 Range 6.1 to 6.9 seconds, Average 6.5 seconds.
  • Page 92 Patient Monitor User’s Manual Response of HR to QRS Adult: without response amplitude is 1mVp-p, width is 10ms 0 bpm to 300 bpm, high/low limit can be Alarm range adjusted continuously. A.7.2 RESP Specifications RESP Method Impedance Measuring lead Lead I(RA-LA)、 II(RA-LL)optional，...
  • Page 93 Patient Monitor User’s Manual Resp bandwidth(BW) 0.25~2.0Hz(-3dB) Measurement range 0~150 rpm The high/low limit can be adjusted continuously Resolution 1 rpm Accuracy ±2 rpm or ±2% A.7.3 BLT­SpO2 Measurement 0~100% range Resolution Accuracy 70~100%：± 2% Alarm Select the high and low alarm limit of Sensor Pulse oximetry sensors contain LEDs that emit red light at a wavelength of...
  • Page 94 Patient Monitor User’s Manual sensor LEDs is less than 15 mW. This information may be useful to clinicians, such as those performing photodynamic therapy. Data update period Anti-interference Anti-motion interference Anti-electrotome interference Resisting low With powerful ability of resisting low perfusion ability perfusion, PR amplitude can reach to 0.2% with value of SpO2 displaying.

  • Page 95: Appendix B Factory Defaults

    Patient Monitor User’s Manual Appendix B Factory Defaults This section lists the most important factory default settings. These settings can be adjusted and you can load the factory defaults if you need. B.1 Alarm Setup Alarm Setup Factory Default Alarm volume Medium Minimum alarm...

  • Page 96: Ecg Setup

    Patient Monitor User’s Manual B.3 ECG Setup HR setup Adult Pediatric Neonate HR High Limit HR Low Limit RESP Adult Pediatric Neonate Resp High Limit Resp Low Limit B.4 SpO2 Setup Setup Adult Pediatric Neonate SpO2 High Limit SpO2 Low Limit PR Setup Adult Pediatric...

  • Page 97: Appendix C Alarm Message

    Patient Monitor User’s Manual Appendix C Alarm Message This section lists some important alarm message. In the tables below, “*” means the alarm level is user-adjustable. C.1 Physiological Alarm SpO2 Cause Level Alarm Messages SpO2 Too High High、 Medium A measurement has risen SpO2 Too Low High、...
  • Page 98 Patient Monitor User’s Manual No Pulse The pulse signal was too High weak to be analyzed. Cause Level Alarm Messages HR Too High * A measurement has risen High、 above the high alarm limit or Medium fallen below the low alarm HR Too Low * High、...

  • Page 99: Technical Alarm

    Patient Monitor User’s Manual C.2 Technical Alarm Message Cause Level Sensor Off The SpO sensor detached the patient or the monitor. ECG Sensor Off The ECG sensor detached the patient or the monitor. Communication Communication error or test Error model error. Battery Low The battery power is low Medium...
  • Page 100 Patient Monitor User’s Manual disconnected from the patient Message or the monitor ECG sensor ECG sensor may be Prompt disconnected from the patient Message or the monitor...

  • Page 101: Appendix D Emc

    Patient Monitor User’s Manual Appendix D EMC...

  • Page 102: Appendix E Warranty Registration Card

    Patient Monitor User’s Manual Appendix E Warranty Registration Card Thank you for purchasing products of BLT! Please complete this card and mail back to BLT Service Center in ZHUHAI within one week. If you need any support or the defects occur, please feel free to contact us by telephone or fax.
  • Page 103 Product name: Patient Monitor Product type: M850 Manufacturer: Guangdong Biolight Meditech Co., Ltd. Address: No.2 Innovation First Road, Technical Innovation Coast, Hi-tech Zone, Zhuhai, P.R.China Postcode: 519085 PN: 22-067-0002...

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