Related Manuals for Biolight Meditech M800
Summary of Contents for Biolight Meditech M800
- Page 1 M800 Handheld Monitor User’s Manual Guangdong Biolight Meditech Co., Ltd. No.2 Innovation First Road, Technical Innovation Coast, Hi-tech Zone, Zhuhai , P.R.China http://www.blt.com.cn...
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Page 2: Product Information
Contents of this manual are subject to change without prior notice. Document No.: J/M800CE-A-009 Revision number: V1.4 Release time: 2013.11 Copyright © 2013 Guangdong Biolight Meditech Co., Ltd. All rights reserved. - Page 3 Handheld monitor user’s manual CE mark EC Representative Name: Shanghai International Trading Corp. GmbH (Hamburg) EC Representative Address: Eiffestrasse 80, 20537 Hamburg Germany 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.
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Page 4: Manufacturer's Responsibility
Handheld monitor user’s manual Manufacturer's Responsibility Only under following circumstances will manufacturer be responsible for the safety, reliability and performance of the instrument: installation, expansion, readjustment, renovation or repairs are conducted by the personnel certified by manufacturer. The storage condition, operation condition and ... - Page 5 Handheld monitor user’s manual This manual is based on the maximum configuration and therefore some contents may not apply to your product. If you have any question, please contact us. 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.
- Page 6 Handheld monitor user’s manual 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.
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Page 7: Table Of Contents
Handheld monitor user’s manual Contents Chapter 1 General Introduction.........1 1.1 Intended Use............. 1 1.2 Main Unit..............2 1.3 Display Views............7 Chapter 2 Safety..............1 2.1 Safety Information............ 1 2.2 Explanation of Symbols..........4 Chapter 3 Basic Operations..........1 3.1 Unpacking and Checking..........1 3.2 Getting Started............ - Page 8 Handheld monitor user’s manual 3.12 Wifi Maintenance..........10 3.13 Selecting Wifi............10 3.14 Restoring the Factory Configuration.....11 3.15 Shutting off the Monitor........11 Chapter 4 Alarm..............1 4.1 Alarm Categories............1 4.2 Alarm Levels.............2 4.3 Alarm Indicators............3 4.4 Alarm Status Symbol..........6 4.5 Alarm Tone Configuration........7 4.6 Pausing the Alarm Tones...........7 4.7 Setting the alarm silence...........
- Page 9 Handheld monitor user’s manual 5.6 SpO Alarm Setup............. 6 Chapter 6 Measuring ECG..........1 6.1 Introduction...............1 6.2 Safety Information............ 2 6.3 Monitoring Procedure..........3 6.4 ECG Display............. 7 6.5 ECG Setup..............8 6.6 Drift filter Setup............8 6.7 Hum filter Setup............9 6.8 HR Alarm Setup............9 Chapter 7 Reviewing............1 7.1 Introduction...............1...
- Page 10 Handheld monitor user’s manual 8.6 Disposing of the Batteries........10 Chapter 9 Maintenance and Cleaning....... 1 9.1 Introduction...............1 9.2 Seasonal Safety Checking.........2 9.3 Cleaning the Monitor..........4 9.4 Cleaning SpO Sensor..........5 9.5 Cleaning ECG Cable..........6 9.6 Disposal..............7 Chapter 10 Accessories............1 10.1 SpO ................
- Page 11 Handheld monitor user’s manual Appendix B EMC...............14 Appendix C Factory Defaults........... 20 C.1 Alarm Setup............20 C.2 System Setup............20 C.3 SpO2 Setup.............21 C.4 ECG Setup..............21 C.5 Trend Setup............21 Appendix D Alarm Message..........22 D.1 Physiological alarm..........22 D.2 Technical alarm............23 Appendix E Warranty Registration Card.......
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Page 12: Chapter 1 General Introduction
Handheld monitor user’s manual Chapter 1 General Introduction 1.1 Intended Use M800 handheld monitor is intended for continuously monitoring or spot checking of SpO , PR, ECG and HR signals of single adult, pediatric and neonatal patient. This device can be used in institutions or units with health care capability. -
Page 13: Main Unit
Handheld monitor user’s manual 1.2 Main Unit 1.2.1 Front View Fig 1-1 Front view of the monitor Alarm indicating lamp When an alarm occurs, this lamp will light up as defined below: High level alarm: the lamp quickly flashes red. ... - Page 14 Handheld monitor user’s manual Low level alarm: the lamp lights yellow without flashing. Display screen Left button Press this button to: Enter the main menu under the monitoring screen. Select the highlighted menu item under the menu screen.
- Page 15 Handheld monitor user’s manual It can change the alarm message to prompt message when “Lead off” or “Sensor off” alarm happens. Power button After the batteries are installed: Press this button to turn on the monitor. Press and hold it for 2 seconds to turn the monitor off.
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Page 16: Rear View
Handheld monitor user’s manual Is shut off when the battery is fully charged or not being charged. 1.2.2 Rear View Fig 1-2 Rear view of the monitor Speaker Battery door Chapter 1-5... -
Page 17: Side View
Handheld monitor user’s manual 1.2.3 Side View Topside: Downside: Leftside: Fig 1-3 Side view of the monitor probe / Communication connector ECG cable connector Cord hold Power supply connector It is used to connect the charger stand. Chapter 1-6... -
Page 18: Display Views
Handheld monitor user’s manual 1.3 Display Views This device has a function of automatic display rotation (Gravity Activated) which provides for vertical and horizontal positioning to maximizing space utilization and visibility. 1.3.1 Big Numerics Display Mode 120s Fig 1-4 Big numerics display mode Menu: After startup, 【Menu】... - Page 19 Handheld monitor user’s manual Patient ID No.: When 【Continuous】 is selected for work mode, the value is 0 at all times; when 【Spot-Check】 is selected, the value is between 1 and HR/PR parameter area: HR/PR parameter and its high and low alarm limits are shown in the area. Physiological alarm area: Current physiological alarm information is shown in the area.
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Page 20: Spo 2 Waveform Display Mode
Handheld monitor user’s manual 11. Battery symbol: The symbol indicates the current quantity of electricity of batteries. Caution: Under the ECG waveform Display Mode, function indicating button 【Menu】 will be changed into【Freeze】or【Unfreeze】. 1.3.2 SpO Waveform Display Mode Fig 1-5 SpO waveform display mode waveform area: The waveform shown in the area is current SpO... - Page 21 Handheld monitor user’s manual 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. 1.3.3 ECG Waveform Display Mode Fig 1-6 ECG Waveform Display Mode ECG waveform display area: Waveform shown in the area is current ECG waveform.
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Page 22: Chapter 2 Safety
Handheld 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 ... - Page 23 Handheld monitor user’s manual Warning: Do not use this device during defibrillation. Do not use this device to monitor a paced patient. When the monitor is in use, it must be ensured the batteries have sufficient capacity; otherwise there might such phenomena...
- Page 24 Handheld monitor user’s manual Caution: The monitor can only monitor one patient at a time. In order to have more accurate measurements results, the monitor should be used in quiet and comfortable environment. To guarantee the normal and safe operation of the ...
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Page 25: Explanation Of Symbols
Handheld monitor user’s manual 2.2 Explanation of Symbols Symbol Symbol Note Type CF applied part without defibrillation-proof Attention: Consult accompanying documents (this manual). Direct Current（DC） IPX1 Degree of protection against ingress of liquid Alarm volume off Alarm volume pause parameter alarm off Beep volume off Power supply connector Left/right button... - Page 26 Handheld monitor user’s manual Symbol Symbol Note Down button Date of manufacture Manufacturer CE mark Serial number Power button Short for “Electrocardiogram” Short for “Pulse Oxygen Saturation” Symbol for the marking of electrical and electronics devices according to Directive 2002/96/EC. Chapter 2-5...
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Page 27: Chapter 3 Basic Operations
Handheld monitor user’s manual Chapter 3 Basic Operations 3.1 Unpacking and Checking Open the package. In the package are parts as follows. Take out the monitor and its accessories. Parts Standard Optional Quantity probes √ (DB9 plugs) 3-lead ECG cable √... -
Page 28: Getting Started
Handheld monitor user’s manual 3.2 Getting Started Before you start to make measurements, carry out the following checks on the monitor including all connected modules. ——Check for any mechanical damage; ——Check for any incorrect connection of all the external cables and accessories. Put batteries into the battery compartment. -
Page 29: Starting The Monitor
Handheld monitor user’s manual 3.3 Starting the monitor Press the button to turn on the monitor. The alarm indicating lamp flashes, and then goes out. The system gives a beep and enter the main screen. For you to use the monitor more conveniently, after starting the monitor you can make the following setting as shown in section 3.4 first. -
Page 30: Key Volume Setup
Handheld monitor user’s manual 3.4.2 Key Volume Setup Press the Left button to select the item, then set its value through the Up or Down button. You can select from 0 to 4. 3.4.3 Adjust the Screen Brightness Press the Left button to select the item, then set its value through the Up or Down button. -
Page 31: Selecting The Work Mode
Handheld monitor user’s manual Select【Menu】→【System】to enter the System menu shown as follows: Fig 3-2 System setup window Select the year, month and day on the right of 【Date】, and set them to the current date. Select the hour and minute on the right of 【Time】, and set them to the current time. -
Page 32: Continuous Monitoring Mode
Handheld monitor user’s manual Select【System】→【Maintenance】 ，a password entering window will pop up, input the password and select【OK】to enter the maintenance window shown as follows: Fig 3-3 Maintenance window Select【Work Mode】, you can set the monitor’s wok mode to【Continuous】or【Spot-Check】. 3.6.1 Continuous Monitoring Mode The continuous monitoring mode is intended for long-term monitoring. -
Page 33: Spot-Checking Mode
Handheld monitor user’s manual 3.6.2 Spot-checking Mode Spot-checking mode is intended for short-term on-site measurement. This mode is normally selected to check outpatient when doctors make rounds of the wards. The patient ID will automatically increase from 1 to 99 according to the connecting of SpO sensor or ECG electrode. -
Page 34: Selecting Patient Type
Handheld monitor user’s manual Caution: Only when the monitor isn’t monitoring any patient, connecting its SpO2 sensor or ECG electrode to a patient, the patient ID will add 1 automatically. 3.7 Selecting Patient Type To select the patient type, Select【Menu】→【System】→【Type】. Set【Type】to【Adu】,【Ped】or【Neo】. -
Page 35: Changing The Language
Handheld monitor user’s manual 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. Otherwise, improper patient monitoring and delayed treatment could result. -
Page 36: Wifi Maintenance
Handheld monitor user’s manual Maintenance】, set spSwitch】to【On】or【Off】. If 【D you select【On】, the screen can react to the gravity. When the monitor rotates, the screen will rotates the display direction automatically. 3.12 Wifi Maintenance Select【Menu】→【System】→【Maintenance】,enter the required password. Select【Factory Setup】,then select 【Wifi Maintenance】to set the SSID, Mac No., IP address. -
Page 37: Restoring The Factory Configuration
Handheld monitor user’s manual router automatically. The symbol will display on the upper right of the screen after connecting successfully. The display icon may change according to the intensity of signal. 3.14 Restoring the Factory Configuration If you have changed the system’s configuration and want to restore the factory configuration, follow this procedure: Select【Menu】→【System】. - Page 38 Handheld monitor user’s manual Caution: Under the Spot-check mode, if the monitor is not in use and there is no button operation for more than 5 minutes, the monitor will shut down automatically. Chapter 3-12...
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Page 39: Chapter 4 Alarm
Handheld 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 40: Alarm Levels
Handheld monitor user’s manual 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 41: Alarm Indicators
Handheld monitor user’s manual Medium level alarms Indicate that the patient’s vital signs appear abnormal and an immediate treatment is required. Low level alarms Indicate that the patient’s vital signs appear abnormal and an immediate may be required. By severity, the pulse monitor’s technical alarms can be classified into two categories: medium level alarms and low level alarms. -
Page 42: Alarm Tone
Handheld monitor user’s manual Alarm lamp: According to alarm level, alarm lamp on monitor flashes in different color and speed. Alarm message: Alarm messages are displayed on the screen. Flashing numeric: The numeric of parameter in alarm flashes. -
Page 43: Alarm Lamp
Handheld monitor user’s manual 4.3.2 Alarm Lamp When an alarm occurs, the alarm levels are indicated in the following different visual ways: 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. -
Page 44: Flashing Numeric
Handheld monitor user’s manual 4.3.3 Alarm Message When an alarm occurs, the alarm message will be displayed in the alarm area. The system uses the following symbols to match the alarm level of physiological alarm messages: High level alarms: *** Medium level alarms: ** Low level alarms: * ... -
Page 45: Alarm Tone Configuration
Handheld monitor user’s manual 4.5 Alarm Tone Configuration 4.5.1 Setting the minimum Alarm Volume Select【Menu】→【System】→【Maintenance】→ enter the required password. Select【Min.Alm.Vol.】and then select a value between 0 and 4. 4.5.2 Changing the Alarm Volume Select【Menu】→【General Setup】. Select【Alarm Vol.】and then select a value between X and 4. -
Page 46: Setting The Alarm Silence
Handheld monitor user’s manual The symbol is displayed in the alarm status area Audible alarm starts again automatically after the alarm pause period expires. You can also press the key to restart the audible alarm. 4.7 Setting the alarm silence Press the alarm pause button for 2 seconds to make the alarm silence. - Page 47 Handheld monitor user’s manual The factory configuration is loaded; Set the alarm volume to a nonzero value. When a factory configuration is selected, the alarm volume of the monitor may be lower than the minimum alarm volume. In this case the alarm volume is automatically adjusted according to the minimum alarm volume.
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Page 48: When An Alarm Occurs
Handheld 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 the screen. It is needed to identify the alarm and action appropriately, according to the cause of the alarm. -
Page 49: Chapter 5 Measuring Spo
Handheld monitor user’s manual Chapter 5 Measuring SpO 5.1 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 by oxygenated hemoglobin and deoxyhemoglobin. -
Page 50: Safety Information
Handheld monitor user’s manual 5.2 Safety Information Warning: Use only SpO sensors specified in this manual. Follow the SpO sensor’s instructions for use and adhere to all warnings and cautions. When a trend toward patient deoxygenation is ... - Page 51 Handheld monitor user’s manual Warning: Check the SpO 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 SpO probe or useless SpO probe, please observe all local, state, and federal regulations that relate to the disposal of...
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Page 52: Monitoring Procedure
Handheld monitor user’s manual 5.3 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 SpO Sensor Plug the SpO sensor cable into the SpO connector on the measurement module. -
Page 53: Spo Display
Handheld monitor user’s manual 5.4 SpO Display Parameter Display Fig 5-1 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 Fig 5-2 SpO2 waveform 5.5 PR Display Fig 5-3 PR parameter 1. -
Page 54: Spo Alarm Setup
Handheld monitor user’s manual Caution: During the monitoring of HR and PR, displaying of HR has priority. That is PR will be displayed only when there isn’t HR monitoring. 5.6 SpO Alarm Setup 5.6.1 Switching On/Off SpO Alarm Select【Menu】→【Alarm Setup】. Set the 【... - Page 55 Handheld monitor user’s manual Adjust【Low】:If the SpO measurement is lower than the low alarm limit, the “SpO2 Too Low” alarm will be triggered. 5.6.4 Setting Desat Limit desat means when SpO measuring value is lower than the desat limit, a high physiological alarm will be trigged.
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Page 56: Chapter 6 Measuring Ecg
Handheld monitor user’s manual Chapter 6 Measuring ECG 6.1 Introduction Before mechanical systole, the heart firstly produces electrical excitement, which results in biological current, and conducts the current to the body surface through tissue and humour. Different potential changes take place at various parts of the body, thus body-surface potential differences are formed. -
Page 57: Safety Information
Handheld monitor user’s manual 6.2 Safety Information Warning: It is imperative to only use the ECG electrodes and cables provided by manufacturer or specified in this manual. Users shall use the electrode which has little polarization voltage little contact resistance. -
Page 58: Monitoring Procedure
Handheld monitor user’s manual Warning: Do not use this device during defibrillation. Interference from instruments near the patient and ESU interference can cause problems with the ECG wave. The monitor cannot be directly applied to heart and ... - Page 59 Handheld monitor user’s manual 1. Select sites with intact skin, without impairment of any kind. 2. Clip or shave hair from sites as necessary. 3. Gently abrade the skin to remove dead skin cells to improve the conductivity of the electrode site. 4.
- Page 60 Handheld monitor user’s manual 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 count. For severely burnt patients, it may be impossible to stick the electrodes on and it may be necessary to use the special pin-shape electrodes.
- Page 61 Handheld monitor user’s manual 2. Electrode Placement 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.
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Page 62: Ecg Display
Handheld monitor user’s manual Electrode Electrode Electrode Electrode labels colors labels colors Placement (IEC) (IEC) (AHA) (AHA) Directly below the White clavicle and near the right shoulder Directly below the Yellow Black clavicle and near the left shoulder On the left Green lower abdomen... -
Page 63: Ecg Setup
Handheld monitor user’s manual ECG Waveform Fig 6-3 ECG waveform 1. Lead label 2. ECG scale 3. ECG waveform 6.5 ECG Setup Select 【 Menu】 → 【ECG Setup】 , Press the up and down button to set【Lead】,【ECG Gain】and【ECG Drift】. Lead ：... -
Page 64: Hum Filter Setup
Handheld monitor user’s manual 6.7 Hum filter Setup 1. Select【Menu】→【System】→【Maintenance】 →enter the required password. 2. Select【Factory Setup】→【ECG Maintenance】 → 【Hum】 , Set its value to the local main power frequency. 6.8 HR Alarm Setup 6.8.1 Alarm Switch Setup Select 【 Menu】 → 【Alarm Setup】 , Set 【 Alarm】 of HR to【Off】to shut off HR alarm. -
Page 65: Chapter 7 Reviewing
Handheld monitor user’s manual Chapter 7 Reviewing 7.1 Introduction Select【Menu】→【Trend】to enter trend reviewing window. In the window, you can review SpO and PR data stored before. 7.2 Reviewing Screen Fig 7-1 SpO /HR reviewing window The above is SpO /HR reviewing window. In the window, you can review SpO /HR value measured in different time. -
Page 66: Reviewing Setup
Handheld monitor user’s manual monitoring ECG, the line of 【 HR】 displays the values of HR. While there is no ECG monitoring, the line of 【 HR】 displays the values of PR. 7.3 Reviewing Setup After entering the reviewing window, press the left button to enter 【... - Page 67 Handheld monitor user’s manual change ID No. to browse trend data of related patients. Delete Selected ： To delete trend data of the selected ID No. Delete All：To delete trend data of all patients. Export Trend：To send trend data of the selected ...
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Page 68: Chapter 8 Battery
Handheld monitor user’s manual Chapter 8 Battery 8.1 Introduction The handheld monitor is designed to operate on three 1.5V alkaline AA batteries or a rechargeable lithium ion battery. Under normal circumstances, no special maintenance is needed. When alkaline batteries or a lithium ion battery is used, the battery icon indicates the battery status as follows: Indicates that the power of the battery is full；... - Page 69 Handheld monitor user’s manual Battery power supply can only last for a period of time. If the voltage of batteries is too low, an alarm of “Battery Low” will be triggered. If alkaline AA batteries are used, please change them timely; if a rechargeable battery is used, please insert the monitor to battery charger and connect the charger with commercial power to charge the battery.
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Page 70: Installing Batteries
Handheld monitor user’s manual 8.2 Installing Batteries Battery compartment is at the back of the device, please follow the following steps to install or change batteries. 8.2.1 Opening the Battery Door Turn the monitor off first. Use the screw driver to loose the screw that secures the battery door to the monitor. -
Page 71: Installing The Alkaline Battery
Handheld monitor user’s manual Fig 8-2 Push the battery door 8.2.2 Installing the Alkaline Battery Insert the AA alkaline batteries in the battery compartment, aligning the + on each battery with the + shown inside the battery compartment. Close the battery door and push it upwards. Tighten the screw that secures the battery door to the pulse monitor. -
Page 72: Installing The Lithium Ion Battery
Handheld monitor user’s manual Caution: Do not run the pulse monitor using alkaline batteries of different types or capacities at the same time. 8.2.3 Installing the Lithium Ion Battery 1. Insert the lithium ion battery in the battery compartment, following shown as follows: Press the battery in Fig 8-3 Install the battery 2. - Page 73 Handheld monitor user’s manual Warning: Do not use the charger stand when the alkaline batteries is depleted or no battery is installed. Disconnect the monitor from the patient and stop monitoring before charge the battery. When connect the running monitor to the AC-DC ...
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Page 74: Charging The Lithium Ion Battery
Handheld monitor user’s manual 8.3 Charging the Lithium Ion Battery Handheld monitor Battery charger AC/DC adapter Fig 8-4 Charging device To charge the lithium ion battery: Place the pulse monitor in the charger stand. Connect the AC-DC adapter and plug the adapter into the AC mains. -
Page 75: Optimizing Battery Performance
Handheld monitor user’s manual 8.4 Optimizing Battery Performance A battery needs at least two optimizing cycles when it is put into use for the first time. A battery cycle is one complete, uninterrupted charge of the battery, followed by a complete, uninterrupted discharge of the battery. -
Page 76: Checking The Lithium Battery
Handheld monitor user’s manual 8.5 Checking the Lithium Battery The performance of a battery may deteriorate over time. To check the performance of a battery, follow this procedure: 1. Disconnect the monitor from the patient and stop all monitoring and measuring procedures. 2. -
Page 77: Disposing Of The Batteries
Handheld monitor user’s manual 8.6 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. -
Page 78: Chapter 9 Maintenance And Cleaning
Handheld monitor user’s manual Chapter 9 Maintenance and Cleaning 9.1 Introduction Keep your equipment and accessories free of dust and dirt. To avoid damage to the equipment, follow these rules: 1. Always dilute according the manufacturer’s instructions or use lowest possible concentration. 2. -
Page 79: Seasonal Safety Checking
Handheld monitor user’s manual Warning: For optimal performance, product service should be performed only by qualified service personnel. Caution: If you spill liquid onto the equipment or accessories, contact your service personnel or us. 9.2 Seasonal Safety Checking Note: To ensure the performance and safety of equipment, it must be checked after using 1 year. - Page 80 Handheld monitor user’s manual The data should be recorded in an equipment log. If the device is not functioning properly or fails any of the following tests, the device has to be repaired. ① Inspect the equipment and accessories for mechanical and functional damage.
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Page 81: Cleaning The Monitor
Handheld monitor user’s manual ⑧ Test the patient leakage current Mains voltage on applied part: According IEC 60601-1:1988 + A1:1991 + A2:1995: Limit: type CF: for a.c.: 50uA. Warning: No use-serviceable parts inside, before servicing authorized representative manufacturer. 9.3 Cleaning the Monitor 1. -
Page 82: Cleaning Spo Sensor
Handheld monitor user’s manual especially careful to keep water out of all kinds of cable and outlet on the panel. 4. Do not use abrasive material including wire brush or metal brightener during cleaning because this material will damage the panel and monitor screen. 5. -
Page 83: Cleaning Ecg Cable
Handheld monitor user’s manual Warning: Do not reuse or disinfect the disposable sensor. 9.5 Cleaning ECG Cable 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. -
Page 84: Disposal
Handheld monitor user’s manual To avoid long-time harm to cable, it is suggested that sterilization to the product be conducted only when necessary according to the regulation of your hospital. Do not clean and reuse disposable electrode. 9.6 Disposal Dispose of the monitor in accordance with local environment and waste disposal laws and regulations. -
Page 85: Chapter 10 Accessories
Handheld monitor user’s manual Chapter 10 Accessories 10.1 SpO Nellcor SpO sensor Type Model Patient Category MAX-A Adult finger (patient size>30kg) Pediatric foot/hand MAX-P (patient size 10-50kg) Disposable Neonatal foot/hand MAX-I (patient size 3-20kg) Adult finger or neonatal foot/hand MAX-N (patient size >40 kg or <3 kg) DS-100A Adult... -
Page 86: Ecg
Handheld monitor user’s manual BLT SpO sensor Type Patient Category Adult 15-100-0013 Pediatric 15-100-0014 Reusable Neonatal 15-100-0015 10.2 ECG ECG Electrode Type Patient category Adult 15-100-0008 Disposable Pediatric/ Neonatal 15-100-0009 ECG Cable Type Description Standard Snap 3-lead 15-033-0001 Snap 3-lead 15-033-0002 Chapter 10-2... -
Page 87: Appendix A Product Specifications
Handheld monitor user’s manual Appendix A Product Specifications A.1 Safety Specifications SFDA classification CE classification Type of protection against electric II, with internal power device shock Degree of protection against electric shock Ordinary equipment, without Degree of protection against protection against hazards of hazards of explosion explosion Degree of protection against ingress... -
Page 88: Environmental Specifications
Handheld monitor user’s manual Charger weight ＜100g Charger size 96mm(W)×66mm(H)×78mm(D) AC-DC adapter ＜200g weight AC-DC adapter size 41.5mm(W)×90mm(H)×32mm(D) A.3 Environmental Specifications Operating: 5℃ to +40℃； Temperature Storage: -20℃ to +55℃； Atmospheric Operating: 700hPa to 1060hPa； pressure Storage: 500hPa to 1060hPa； Operating: 15% to 85%(non condensing) Humidity Storage:... - Page 89 Handheld monitor user’s manual Capacity 2000mAh Voltage 1.5V DC Quantity Indication of There are five status including empty ,1,2,3 and battery capability full. Run time >14 hours With ECG, SpO monitored continuously, Wifi off, Audio indicators off and backlight brightness set to minimum and using new, full power batteries at ambient temperature 25℃.
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Page 90: Hardware Specifications
Handheld monitor user’s manual 4 hours to 100% Shutdown delay 10min（After the first “low battery” alarm） Indication of There are five status including empty ,1,2,3 and battery capability full. Type AA NI-MH battery Capacity 2100 mAh Voltage 1.2 VDC Quantity A.5 Hardware Specifications A.5.1 Display Type... -
Page 91: Audio Indicating
Handheld monitor user’s manual Charger LED 1(Green) When connecting to the AC-DC adapter, it AC power lights green; indicating lamp When disconnecting from the AC-DC adapter, it doesn’t light. A.5.3 Audio indicating Speaker Gives audible alarm, button tone and beep tone Supports Pitch Tone and multi-level volume;... -
Page 92: Data Storage
Handheld monitor user’s manual A.5.5 Sensors Pulse oximetry sensors contain LEDs that emit red light at a wavelength of approximately 660 nm and infrared light at a wavelength of approximately 905 Wavelength The total optical output power of the sensor LEDs is less than 15 mW. -
Page 93: Usb Communication
Handheld monitor user’s manual A.7 USB Communication USB to DB9 connector In compliance with IEC 62680 Steady communication 1.0 meters distance A.8 Measurement Specifications A.8. 1 SpO Specifications Fulfill the requirement ISO 9919 Measurement technique Digital SpO technique alarm range and 50%～100%，the high and low limit is error adjustable，alarm error is ±1%... -
Page 94: Nellcor Spo
Handheld monitor user’s manual Range 0~100% Resolution 70% to 100%: ±2% Accuracy 0% to 69%: unspecified Alarm Select the high and low alarm limit of SpO Refreshing rate <13 seconds Pitch Tone with Range 25 bpm to 250 bpm Resolution 1 bpm Accuracy ±1% or ±1bpm , whichever is the greater... - Page 95 Handheld monitor user’s manual 70% to 100%: ±3%（neonate） 70% to 100%: ±2%（low perfusion） 0% to 69%, unspecified Refreshing rate Pitch Tone with Range 20bpm to 300bpm Resolution 1bpm 20bpm～250bpm: ± 3bpm Accuracy 251bpm～300bpm: unspecified Refreshing rate A.8.2 ECG Comply with EN 60601-2-27 / IEC Standard 60601-2-27、ANSI/AAMI EC 13:2002 Lead type...
- Page 96 Handheld monitor user’s manual Input current <0.1 uA Baseline recovery ≤ 3 s Electrode offset ±300 mV d.c. potential ECG signal input -6.0mV to +6.0mV range Leakage current ＜10 uA CMRR ≥90dB Bandwidth (-3d B) 0.5Hz to 40Hz Noise ≤30μV p p RT I Standardizing signal 1mV ±5% Electrode off...
- Page 97 Handheld monitor user’s manual sensitivity 12.5mm/s，25 mm/s Scan speed Electric isolation voltage is 4000V at Protection 50Hz/60Hz., defibrillator-proof. Defibrillator-proof Recovering time for defibrillator-proof ≤5s Recovering time of ECG waveform will recover to the baseline electrode polarization within 10 seconds. after defibrillation Pacemaker pulse rejection amplitudes Without...
- Page 98 Handheld monitor user’s manual 50 bpm to 120 bpm, once every four beats; > 120 bpm, once every six beats. Ventricular bigeminy : 80bpm Heart rate meter Slow alternating ventricular bigeminy : accuracy and 60bpm response to irregular Rapid alternating ventricular bigeminy : rhythm 120bpm Bidirectional systoles : 90bpm...
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Page 99: Alarm Limit Specifications
Handheld monitor user’s manual Vent Tachycardia 2mVp-p, 195bpm: Gain 0.5, Range 5.4 to 6.2 seconds, Average 5.8 seconds Gain 1.0, Range 5.7 to 6.5 seconds, Average 6.1 seconds A.8.3 Alarm limit specifications Alarm limits Range(%) Step(%) SpO2 high limit (low limit +1) to 100 SpO2 low limit Desat to (high limit -1) Alarm limits... -
Page 100: Appendix B Emc
Guidance and manufacturer’s declaration – electromagnetic emission The M800 HANDHELD MONITOR is intended for use in the electromagnetic environment specified below. The customer of the user of the M800 HANDHELD MONITOR should assure that it is used in such and environment. - Page 101 Guidance and manufacture’s declaration – electromagnetic immunity The M800 HANDHELD MONITOR is intended for use in the electromagnetic environment specified below. The customer or the user of M800 HANDHELD MONITOR should assure that it is used in such an environment.
- Page 102 Guidance and manufacturer’s declaration – electromagnetic immunity The M800 HANDHELD MONITOR is intended for use in the electromagnetic environment specified below. The customer or the user of M800 HANDHELD MONITOR should assure that it is used in such an environment.
- Page 103 Immunity IEC 60601 test Complian Electromagnetic environment - test level ce level guidance Portable mobile communications equipment should be used no closer to any part of the M800 HANDHELD MONITOR, including cables, than recommended separation distance calculated from equation applicable to the frequency of the transmitter.
- Page 104 MONITOR The M800 HANDHELD MONITOR is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the M800 HANDHELD MONITOR can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the M800 HANDHELD MONITOR as recommended below, according to the maximum output power of the communications equipment.
- Page 105 Handheld monitor user’s manual Separation distance according to frequency of transmitter Rated maximum output power of transmitter 150 kHz to 80 MHz 80 MHz to 800 800 MHz to 2.5 ...
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Page 106: Appendix C Factory Defaults
Handheld monitor user’s manual Appendix C 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. C.1 Alarm Setup Alarm Setup Factory Default Alarm Vol Alarm Level PR Alarm Level HR Alarm Level... -
Page 107: Spo2 Setup
Handheld monitor user’s manual C.3 SpO2 Setup Setup Adult Pediatric Neonate SpO2 High Limit SpO2 Low Limit PR Setup Adult Pediatric Neonate PR High Limit PR Low Limit C.4 ECG Setup ECG Setup Adult Pediatric Neonate HR High Limit HR Low Limit Lead Ⅱ... -
Page 108: Appendix D Alarm Message
Handheld monitor user’s manual Appendix D Alarm Message This section lists some important alarm message. In the tables below, “*” means the alarm level is user-adjustable. D.1 Physiological alarm Messages Cause Level Too High* A measurement has risen above the high alarm limit or Too Low* Medium fallen below the low alarm... -
Page 109: Technical Alarm
Handheld monitor user’s manual D.2 Technical alarm Messages Cause Level Sensor Off The SpO sensor detached the patient or the monitor. Lead Off The ECG leads were Medium disconnected ECG Polarized ECG electrode polarized Battery Low The battery power is low. Low Perf The signal detected is weak. -
Page 110: Appendix E Warranty Registration Card
Handheld 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 111 Product name: Handheld Monitor Product type: M800 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：22-033-0001...
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