Patient Monitor DS-101 System Ver.03 Operation Manual * Before using the product, please read this manual thoroughly. * Store this manual where it can be always referred to. Fukuda Denshi Co Ltd.
© 2017 Fukuda Denshi. All rights are reserved. To support the intended use of the product described in this publication, the purchaser of the products is permitted to copy this publication, for internal distribution only, from the media provided by Fukuda Denshi.
Contents Contents .........................................................................................................................................................1 Introduction .....................................................................................................................................................4 Intended Use ...............................................................................................................................................
Menu......................................................................................................................................................35 Menu .............................................................................................................................................................36 Display Mode ............................................................................................................................................36 Patient ..........................
Select a cuff ...........................................................................................................................................67 Cuff measurements ...............................................................................................................................67 Position the cuff .....................................................................................................................................67 NIBP measurement .....................................
Introduction This manual (direction for use) is designed to help you understand the capabilities and operation of the Fukuda DS-101 series of monitors. The information in this manual, including the illustrations, is based on a monitor configured with electro-cardiogram (ECG), heart rate, noninvasive blood pressure (NIBP), body temperature, pulse oximetry (SpO2), and pulse rate. If your monitor configuration lacks any of these options, some information in this manual may not apply.
Symbols Documentation symbols WARNING The warning statements in this manual identify conditions or practices that could lead to illness, injury, or death Caution The caution statements in this manual identify conditions or practices that could result in damage to the equipment or other property, or loss of data Read operating instructions Power symbols Power on / standby Monitor is plugged into Alternating Current power present, battery fully charged Alternating Current power present, battery is charging
Screen elements Navigation HR Sync Mark Lead off SpO2 Sync Bar Probe Off message SpO2 Finger Off message RESP Resp Sync Bar NIBP NIBP Oscillation Bar NIBP Auto Interval Timer Save Auto Save On Alarm and information messages Page 6 Alarm Off Alarm Pause & Count Down Timer Audio Pause Button Audio Pause & Count Down Timer
About warnings and cautions Warning and caution statements can appear on the monitor, on the packaging, on the shipping container, or in this document. The monitor is safe for patients and clinicians when used in accordance with the instructions and with the warning and caution statements presented in this manual. Before using the monitor, familiarize yourself with the sections of this direction for use that pertains to your use of the monitor.
and cleaned by a qualified service technician. WARNING Liquid can damage electronics inside the monitor. Prevent liquids from spelling on the monitor. If liquids are spilled on the monitor: 1. Power down the monitor 2. Disconnect the power plug. 3. Remove battery pack from the monitor. Note Remove battery pack shall be proceed by trained specialist and shall not be proceed by user 4. Dry off excess liquid from the monitor.
WARNING Inaccurate measurement risk. Do not expose to temperatures higher than 42.9°C WARNING Inaccurate measurement risk. Do not use the monitor on patients who are on heart-lung machines. WARNING Use the monitor only as described in this directions for use. Do not use the monitor on patients as described in the Contraindications. WARNING Inaccurate measurement risk. Do not use the monitor on patients who are experiencing convulsions or tremors.
WARNING Conductive parts of electrodes and associated connectors for type BF or CF applied parts, including the NEUTRAL ELECTRODE, should not contact any other conductive parts including earth WARNING The stored data will not be affected. The measurement accuracy will temporarily decrease during electrosurgery, but it will not compromise the safety of patient and the equipment. WARNING To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth.
settings. Caution Never move the monitor or mobile stand by pullimg on any of the cords as this may cause the monitor to tip over or may damage the cord. Never pull on the power cord when removing it from the power outlet. When disconnecting the power cord, always grasp the attachment plug and not the cord. Keep the cord away from liquids, heat, and sharp edges. Replace the power cord if the strain relief or cord insulation is damaged or being to separate from the attachment plug.
l Regular testing of devices and accessories on a daily basis (by the clinical OPERATOR) and on a scheduled basis (as a service activity) is recommended. Caution Immediate maintenance has to be carried out for the following case. l When the equipment was subjected to extreme mechanical stress, e.g. after a heavy fall. l When the equipment was subjected to liquid spill. l When the monitoring function is interrupted or disturbed. l When parts of the equipment enclosure are cracked, removed, or lost.
Controls, indicators, and connectors Feature Light bar Light bar LCD screen Description Provides a visual alarm with red and blue LEDs. Provides a synchronized heartbeat with green LEDs. 4 5 6 Power switch NIBP connector ECG connector Power-on/Standby switch. Self-contained module for easy replacement. 7 SpO2 connector Self-contained module for easy replacement. Supports Clip-type or Tape-type SpO2 sensors.
① ② ③ ④ ⑤ ⑥ ⑦ No. 1 Page 14 Feature Speaker Description Provides an audible Alarm (low or high) and synchronized heartbeat sound. 2 3 Handle AUX-1 connector 4 AUX-2 connector Provides a connection to optional medical devices. 5 6 7 IO connector Power connection IO connector Connect to display module Provides an external AC power connection. Connect to Main module. Provides a connection to secure USB-memory for software upgrades.
Setup WARNING The labels on the external box are best to be read at a distance of 30 cm due to the small label size. To unpack the DS-101, follow the steps below: 1. Use box cutters, a knife or a sharp pair of scissors that seals the box. 2. Open the box. 3. Lift the DS-101 out of the box. 4. Pull the plastic cover off the DS-101. 5. Make sure all the components listed in the packing list are present.
1 USB Cable USB-101 Stand 1 Stand 101STAND Accessory 1 SpO2 sensor SPO-10RAC3M Reuseable(3m) Clip type 1 ECG CABLE Leads) (3 CMO-101HR3 1 NIBPcuff for adult M CUF-101M (23-33 cm) (30 to 280mmHg) 1 Page 16 NIBP relay horse OA-101AP
Accessory (Option) 1 SpO2 sensor SPO-11RAT3M Reuseable(3m) Tape type 1 ECG CABLE CMO-101HR12 12Leads (3m) 1 NIBP cuff for adult L CUF-101L (31-43 cm) (30 to 280mmHg) 1 NIBPcuff for adult S CUF-101S (17-25 cm) (30 to 280mmHg) 1 NFC Thermometer BT-A71-NFC Page 17
Hardware installation Installation precautions WARNING Failure to take installation precautions during the maintenance of the device may result in permanent damage to the device and severe injury to the user. When installing the DS-101, please follow the precautions listed below: 1. Install and keep the instrument away from splashing water. 2. Protect the instrument from shock and vibration while transporting it. 3. Do not install the instrument where humidity, ventilation, or direct sunlight. 4.
3. Connect the micro USB cable. Plug the 180-degree connector into the Display connector of the USB-BOX, and plug the 90-degree connector into the Module connector of the DS-101. Charging the system To charge the DS-101, follow the steps below. 1. Connect the DS-101 with a power source through the power adapter came with the package. 2. The system starts to charge the battery and the power status LED lights up in amber indicating the battery is being charged.
3. The user can turn on the system to check the battery capacity on the top right corner of the screen. Note The battery can only be fully charged when the battery level is lower than 95% due to battery overcharge protection. In other words, the battery will not be charged after plugging in the power source when the battery level is in between 95% and 99%. DS-101 connection Illustrate the connection concept of the DS-101.
NIBP relay horse Connection Line up the alignment tab of the NIBP relay horse connector with the notch of the NIBP connector of the USBBOX. Then, plug in the connector and make sure the connection is secure.
ECG cable connection Line up the alignment tabs of the ECG cable connector with the notches of the ECG connector of the USBBOX. Then, plug in the connector and make sure the connection is secure. SpO2 cable connection Line up the alignment tab of the SpO2 cable connector with the notch of the SpO2 connector of the USBBOX. Then, plug in the connector and make sure the connection is secure. Caution Observe the patient and instrument closely during use.
Power up the system To power-up the system, push the power button on the right side panel for three seconds until the power status LED on the front panel lights up in green. The following table lists the power LED status description.
2. Lift the battery pack and pull it out gently until the battery connector shows. 3. Disconnect the battery connector. 4. Connect the battery connector of the new battery pack to the battery connector of the DS-101 by correctly orienting the connector (align keying feature) onto the mating connector.
5. Gently organize and insert the connectors and cables back to the original position inside the DS-101. 6. Slide the new battery pack in at an angle to install it. 7. Secure the battery access panel with the two previously removed retention screws.
Start up Power on screen The following screen appears when the system is turned on. Patient login The top of the Patient page displays the heart rate (HR) and the waveform detected by the sensor. The page also contains three option buttons for users to choose: l Admin New Patient: Delete patient data, and enter the Patient Register page (refer to Section 0). l Quick Admit: Delete patient data, and enter the Monitor Mode page or the Large Mode page.
Patient registration The Patient Registration page shown below allows users to input patient information. Default Setting The default setting at the start of monitoring is as follows. The system setting can set whether to default or continue. Parameter Parameter ECG Monitor Item ECG Lead Sensitivity Detail I, II, III x0.
Filter Hum Filter Pacing Detect Diag., Monitor, Drift Cut ON, OFF ON, OFF Drift Cut ON OFF ECG 12 leads Sensitivity Low Cut Filter High Cut Filter Hum Filter Pacing Detect x0.25, x0.5, x1, x2, x4 0.05Hz, 0.15Hz, 0.3Hz 30Hz, 150Hz, 250Hz, OFF ON, OFF ON, OFF x1 0.05 OFF ON OFF NIBP Pressure Pre-set Pressure Limit Auto Interval 120, 150, 180, 200 150, 200, 250, 300 ON, OFF 180 250 OFF RESP RESP Lead Sensitivity I, II x0.2, x0.
Monitoring Main Screen Patient information, battery life, dates and countdown timer are displayed at the top of the page in the Monitor Mode. The countdown timer in green indicates the remaining time for next auto blood pressure check. If the number is absent, that means the auto check function is disabled. Other displayed values are described below: HR: heart rate. A heart icon and a beep will be generated every time the ECG peak is detected.
l l RESP: the number of breaths TEMP: press TEMP to enter the page with detail temperature information Large screen Patient information, battery life, dates and countdown timer are displayed at the top of the page in the Monitor Large Mode. The countdown timer in green indicates the remaining time for next auto blood pressure check. If the number is absent, that means the auto check function is disabled. Other displayed values are described below: l HR: heart rate.
¡ ¡ ¡ ¡ range, the warning sound and icon will be triggered. Dia in orange: Diastolic pressure. The small number on the side indicates the normal range of diastolic pressure. If the diastolic pressure exceeds the normal range, the warning sound and icon will be triggered. CUFF: the pressure of the cuff Press START/STOP to start the checkup. After start, press START/STOP again can stop the checkup. Press any place other than the START/STOP button to enter the page with detail information of the NIBP check.
SpO2 mode If SpO2 waveform is displayed in a bigger area, user can change waveform amplitude to see more detail. Pause If an abnormal waveform is found, the user can click at the waveform display area to stop waveform update, allowing the user to check the abnormal waveform. Full Disclosure User can review previous waveform.
Disclosure button as shown in the figure. When it comes to the right end, it scrolls and displays the data for one minute Trend User can check NIBP, SpO2, heart rate or temperature trend. Alarm History User can check the latest alarm history. List User can check all latest events in a list. Event If there are ECG/SpO2/NIBP/Respiration/Temperature/Manual operations, those events will be recorded on the timescale.
Print If the user clicks the Print button then the following message box will pop up. The user can select proper printer to print the waveform. Caution Print setting need to go to Window Desktop as descript in Power off section. Caution Print function is based on Window system, Fukuda Denshi is not responsible for the integrity of any installation or upgrade not performed by authorized Fukuda Denshi service personnel.
Menu The Menu page contains several buttons for accessing the setting options of each function. In dual channel mode, ECG mode and ECG Cascade mode, the upper area of the Menu page always displays ECG waveform and heart rate number. In SpO2 mode, the upper area always displays SpO2 waveform and pulse rate number. Click EXIT to go back to the Main Screen.
Menu Display Mode l l l l The Display page allows users to select monitor mode and waveform display mode. The options include: Mode Select: ¡ Main Screen ¡ Large Screen ¡ 12 Lead ECG Monitor Wave: ¡ Dual Channel ¡ ECG ¡ ECG Cascade ¡ SpO2 BACK: go to Menu page. EXIT: exit the Menu page and go back to the Main Screen. Patient The Patient page allows users to input patient information, delete patient record or tentative discharge.
ALARM Click each icon to enable or disable alarm function. User can set a normal range. If the measured value is not in the normal range then the alarm will be triggered. Review Full Disclosure Users can check ECG shrinking waveform in the upper area (Area 1). If the user wants to see certain part of ECG, please click on Area 1 to have the ECG waveform display original ECG waveform in Area 2.
The Full Disclosure page also contains the following buttons: l : go back 10 minutes. l : go forward 10 minutes. l : jump to the end. l l l l l Timescale : ¡ Green bar: there are ECG waveforms in the database. ¡ Yellow dots: there are events at that time ¡ Red dots: there are alarms triggered at that time 1/13, 1/14, 1/15, 1/16: change Timescale range. Print Page: print full disclosure waveform. BACK: go to Menu page EXIT: go to Main Screen.
The Trend page also contains the following buttons: l : go back 6 hours. l : go forward 6 hours. l : jump to the end. l l l l Timescale : ¡ Green bar: there are ECG waveforms in the database. ¡ Yellow dots: there are events at that time ¡ Red dots: there are alarms triggered at that time 1/13, 1/14, 1/15, 1/16: change Timescale range. BACK: go to Menu page EXIT: go to Main Screen. Alarm History The Alarm History page displays heart rate, SpO2, NIBP, respiration alarm time and related data.
l EXIT: go to Main Screen. List The List page displays all alarm, manual operation, time and related data. If you double click alarm column, it will lead to the Review page. The List page also contains the following buttons: l : jump to previous 10 items. l : jump to next 10 items. l : jump to the end. l l l l l l Timescale : ¡ Green bar: there are ECG waveforms in the database.
The Event page also contains the following buttons: l : go back 1 hour. l : go forward 1 hour. l : jump to the end. l l l l Timescale : ¡ Green bar: there are ECG waveforms in the database. ¡ Yellow dots: there are events at that time ¡ Red dots: there are alarms triggered at that time 1/13, 1/14, 1/15, 1/16: change Timescale range. BACK: go to Menu page EXIT: go to Main Screen.
The Review page also contains the following buttons: l Previous: previous stored image. l Next: next stored image. l Print: print image l Email: email to someone. l BACK: go to Alarm History page or List page. Parameter Set-up ECG monitor The ECG Main Screen contains the following setting options and buttons: l ECG Lead: select Lead source.
The ECG 12 Leads page contains the following setting options and buttons: l Sensitive: adjust ECG amplitude l Low Cut Filter: select frequency l High Cut Filter: select frequency l Hum Filter: disable or enable hum filter l Pacing Detect: disable or enable pacing detect l Rhythm Lead: select ECG source l BACK: go to Menu page. l EXIT: go to Main Screen. NIBP The NIBP page contains the following setting options and buttons: l Pressure Pre-Set & Pressure Limit: setting the air pump range.
The RESP page contains the following setting options and buttons: l RESP Lead: select respiration lead l Sensitivity: adjust waveform amplitude. l BACK: go to Menu page. l EXIT: go to Main Screen. Set-up Sound/List The Sound/List page contains the following setting options and buttons: l Beep Sound Volume: adjust beep sound volume. l Alarm Volume: adjust alarm volume. l Auto List Interval: depend on interval setting to store Monitor image. l System Mode: select different parameter setting.
The System 1 page contains the following setting options and buttons: l Date: select date format l Time: set system time l Unit: change height and weight unit. l Language: select language l Hum Filter: select filter frequency. The System 2 page contains the following setting options and buttons: l Operation mode: Use as “Stand Alone” or “Network Mode”, currently these two mode has no difference.
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The System 3 page contains the following setting options and buttons: l E-mail Setting: Set the email related information for sending mail function, image as below. l CMS Setting: Setting up CMS IP information, current version software does not enable this function.
Power Off The Power Off page provides the following three options for users to power off the system or to close the application: l Standard Shutdown Press “Standard ShutDown” button. DS-101 turns off l Sleep Mode Press “Sleep mode Shut Down” button. DS-101 enters sleep mode. Press the power button to start up quickly. l Exit Software Press button. Entering the password and return key, ends DS-101 and returns to Windows.
Alarms The monitor presents physiological alarms and technical alarms. Physiological alarms occur when vital sign measurements fall outside of set alarm limits. Alarm types Type Heart Rate, Respiration rate, SpO2, NIBP, or Pulse rate limit exceeded Some technical alarms Priority High Color Red Alarm audio tone 5-pulse tone Low Blue 1-pulse tone Non-latching alarm The alarm of this monitor is non-latch type. The alarm stops when the vital sign returns within the set alarm limits.
Main screen notifications Notification Description Information area Audio pause button appears when alarm occurs. If the audio pause button is pressed, a timer countdown appears. If monitoring is started within 1 minute (or 2 minutes), or alarm pause button is pressed, alarm does not work. During that time countdown timer is displayed. (Depending on the setting in 1 or 2 minutes) Parameter area Display alarm information with red (high priority) or blue (low priority) frame.
Alarm off. No visual and audio alarms occur. Alarm paused. Audio and visual notifications are paused for a period ranging from 1 to 2 minutes. This icon remains until the pause time counts down to 0. Audio paused. The audio tone is paused for a period ranging from 1 to 2 minutes. This icon remains until the pause time counts down to 0. Reset (pause or turn off) audio alarms 1. Alarm occur l Audio and visual alarm occur when vital sign measurements fall outside of set alarm limits 2.
Modify audio pause, alarm pause period You can modify the period of audio alarm pause 1. Touch the Menu key. 2. Touch the Alarm setting key. 3. Touch the Period setting key 4. On the Period setting screen, modify period. Adjust vital sign alarm limits You can adjust vital sign alarm limits or turn off alarm limit checking for individual parameters. WARNING Alarm limits are user adjustable. All alarm limit settings should be set accordingly for each patient. 1. Go to the Alarm setting screen.
alarm. If you turn off alarm, no visual or audio alarm signals will occur for those parameters. If the alarm is off, the icon on the Main screen in the parameter area. Default alarm limit You can set the alarm limit to default with touch the “Default” button. Default alarm limits are follows.
Note You can check the alarm sound volume by pressing the Check key. Alarm Confirmation You can check past alarms. On Main screen 1. Touch the Alarm History key. 2. You can check up to 8 alarms in the past. On Review screen 1. Touch the Menu key. 2. Touch the Alarm History in the Review category. 3.
4. Double-click on the alarm time to check the waveform at that time.
Finger-off Page 56 SpO2 frame SpO2 sensor is out of finger
Patient monitoring ECG ECG frame From the ECG frame, you can measure Heart Rate (HR). Located in the upper right corner of the Main screen, the ECG frame contains data and features relevant to ECG. (Main Screen and Larged Screen) l You can check the Heart Rate l You can see the synchronized heart beat with blinking heart mark. l You can see Heart Rate alarm limits. (Upper and Lower), right of the Heart Rate. l If alarm is off, you can see alarm off mark.
ECG cascade mode l l l ECG lead is displayed on the left side of the screen. Calibration bar linked to the ECG sensitivity is displayed on the left side of the screen. Touch the screen to fix the waveform. WARNING If the system shows “LEAD OFF”, please refer to the trouble shooting section ECG Electrode Placement Please place electrode as below graph ECG Alarm 1. Touch the Menu key. 2. Touch the Alarm Setting key. 3. Heart Rate is displayed in the HR/PR key and the green line on the bar graph 4.
ECG Monitor Setting (Lead, Sensitivity, Filter, Pacing Detect) 1. Touch the Menu key. 2. Touch the ECG Monitor key. 3. You can configure the lead, sensitivity, filter, and pacing detect. 4. Select ECG Lead. l The ECG function can use 3 wire and 10 wire lead. l Only I, II, III leads can be selected regardless of which lead is used. l Choose the lead with the QRS of ECG, the largest on the monitor. 5.
Note Detection of ischemia is the interpretation of the clinician only, the DS-101 does not provide automated ischemia detection. Note It is normal for the ECG baseline to wander slightly in Diag. Filter. 7. Turn on the Hum Filter with the intended use. Turn on when AC noises enter even if electrode and lead wires are adjusted. 8. Turn on the Pacing Detect with the intended use. l Used for pacemaker patients. l Pacing Detection is on, the DS-101 displays pacemaker signals exactly as they are captured.
RESP display l The Respiration waveform is display on the left of the RESP frame (Main Screen). l The Respiration synchronized bar is display on the left of the RESP frame (Large Screen). RESP Alarm 1. Touch the Menu key. 2. Touch the Alarm Setting key. 3. Respiration rate is displayed in the Resp key and the green line on the bar graph. 4. To set the Respiration Rate alarm limits, use the arrow key on the right side of the screen to follow these steps: 5.
4. Select RESP Lead Respiration Rate is measured with the ECG leads. As the chest expands and contracts during the respiration cycle, the resistance, or impedance, between the RA-LA electrodes (Lead I) changes. The result of these changes indicates the respiration rate. If the respiration waveform is small, change it to lead II (RA-LF). 5. Select Sensitivity. The amplitude of the respiration waveform is 10 mm with 1-ohm impedance change at x1.
Pulse wave display l The Pulse waveform is always display on the bottom of the Main screen, expect of ECG 1ch, ECG cascade modes. ECG & SpO2 mode SpO2 mode l l Amplitude of the pulse wave is automatically adjusted. Touch the screen to fix the waveform. PR display When pulse only mode is selected, Heart Rate (HR) display changes to Pulse Rate (PR) display. You can check the Pulse Rate on ECG frame.
Measure SpO2 and pulse rate SpO2 and pulse rate monitoring continuously measures saturation level of oxygen in hemoglobin as well as the pulse in a patient through a pulse Oximeter.
3. Attach the SpO2 sensor to the patient according to the manufacturer’s directions for use, observing all warnings and cautions. Note If a sterile sensor is required, select a sensor that has been validated for sterilization, and follow the sensor manufacturer’s direction for use to sterilize the sensor. Place the SpO2 sensor and the NIBP cuff on different limbs to reduce unnecessary alarms when you monitor NIBP and SpO2 at the same time.
l When measuring blood pressure, cuff pressure is displayed and pulsation is indicated by vertical bar graph. NIBP measure window Touch the NIBP frame except the start/stop key opens a NIBP Measure window l l l l The frame can display Systolic and Diastolic measurements. You can see blood pressure alarm limits. (Upper and Lower) You can see previous NIBP measurement data. When blood pressure is measured, a graph of cuff pressure and pulsation is displayed. NIBP Alarm 1. Touch the Menu key. 2.
Select a cuff WARNING Use only blood pressure cuffs and hoses listed as approved accessories to ensure safe and accurate NIBP measurements. WARNING This blood pressure measurement cannot be used for neonates and pediatric. Caution Correct sizing of the blood pressure cuff is important for accurate blood pressure readings. A cuff that is too small might provide false high readings, while a cuff that is too large might provide false low readings.
WARNING Patient injury risk. Do not use the NIBP for continuous monitoring without frequently checking the patient’s limb. When a patient is being monitored frequently or for a prolonged period, regularly remove the cuff to inspect it and to check the cuff site for ischemia, purpura, or neuropathy. WARNING Inaccurate measurement risk. Do not place the cuff where it can disturb proper circulation.
The monitor measures blood pressure as the cuff is inflating. If patient movement, excessive noise, or an arrhythmia prevent the monitor from determining the blood pressure while the cuff is inflating, the monitor inflating the cuff pressure again. When the measurement is complete, the NIBP frame displays the measurement until you start another NIBP measurement. Take a manual NIBP measurement 1. 2. WARNING Patient injury risk.
When the interval measurement is complete, the NIBP frame displays the measurement until the next measurement is complete. The result of the interval measurement is saved as event data. Note The result of the interval measurement is saved as event data Note During intervals, each automatic and manual measurements clears all measurements from NIBP frame. Temperature Temperature frame From the temperature frame you can measure patient temperature.
WARNING Patient injury risk. Prior to taking a temperature, instruct the patient not to bite down on the probe as patient injury and damage to the probe may result. Caution Probe covers are disposable, nonsterilized, and single-use. Probes are also nonsterilized. Do not autoclave proves and probe covers. Ensure that prove covers are disposed of according to facility requirements or local regulations. 1. Press the power button on the thermometer to turn it on. Sounds urge measurement 2.
10. Touch exit to return Main screen, and temperature frame displays the temperature.
12 Lead ECG In this mode, 12-lead electrocardiogram for measurement is measured with 10 leads cable. 3 lead cable is not suitable to use. Vital sign alarm does not function because it is not continuous monitoring. For that reason, Display setting of the MENU is separate from Monitoring. 12 Lead ECG display 12 lead ECG is displayed for limb lead and chest lead for 5 sec. 12 Lead ECG Alarm 12 L ECG does not have HR or arrhythmia alarm, it has only lead-off alarm.
12 Lead ECG Setting (Sensitivity, Filter, Pacing Detect) 1. 2. 3. 4. Touch the Menu key. Touch the ECG 12 Leads. You can configure the sensitivity, filter, and pacing detect. Select Sensitivity The height of the vertical ruler that appears to the left of the ECG waveform indicates 1 mV amplitude and is 10 mm high if x1 is chosen. 5. Select the Low Cut Filter in accordance with the intended use. l l This is standard for measurement ECG.
Turn on when AC noises enter even if electrode and lead wires are adjusted. 8. Turn on the Pacing Detect with the intended use. l Used for pacemaker patients. l Pacing Detection is on, the DS-101 displays pacemaker signals exactly as they are captured. 12 Lead ECG Electrode Placement For 12 lead ECG, please place electrode as below graph 12 Lead ECG Measurement Measurement value can be obtained by pressing the analysis button and measuring the 12L ECG for 10 seconds 1. 2. 3. 4. 5. 6.
7. You can see 7 button l SAVE: Save 12L ECG waveform with measurement value. Reviewable by List. l PRINT: Print 12L ECG waveform with measurement value. l BACJ: Go back to 12L ECG display mode. l 0 – 5 s: Review 0 – 5sec waveform l 2.5 – 7.5 s: Review 2.5 – 7.5sec waveform l 5 – 10 s: Review 5 – 10sec waveform l Gain: You can change the sensitivity, Touching x1(10mm/s) – x2(20mm/s) – x4(40mm/s) – x0.25(2.5mm/s) – x0.5(5mm/s) in turn 8. You can see the enlarged waveform by touching the waveform. 9.
12 Lead ECG Measurement Value You can see 12 lead ECG measurement value are as follows.
Specification Specification DS-101 Specifications Specification DS-101 CPU Intel® Celeron® processor N2807 Memory On-board 2 GB 1333 MHz DDR3L Boot-up Time < 60 seconds OS Windows Embedded Standard 7 Storage 16 GB SSD mSATA module OpenGL Supported Display Size 10.1” LCD display Aspect Ratio 16:10 Resolution 1280 x 800 Interface LVDS Backlight LED 2 Brightness (cd/m ) 350 (Typ.
Specification DS-101 LED Light Bar By embedded controller Green: heart beat Red/Yellow/Blue: alarm Battery Battery Type 3S1P 103450 tap Battery Contact Wire Battery Capacity 10.8 V, 2200 mAh Battery Life 1 year Minimum operation time 2 hour Battery Charge time from depletion to 90% About 2 hour Power AC Adapter 60601 grade DC-in Voltage & Current Input: AC 100 V–240 V / 50-60Hz, 0.98A Output: DC 15 V, 2.4 A Quick Charging N/A, 0.
Specification DS-101 USB-BOX Specifications Page 80 Specification HS-101 IO Board Model USB-BOX-IOBD-R10 ECG Connector ECG connector SpO2 Connector Snap latch fixed socket, 6-pin, blue NIBP Connector Snap latch fixed socket, gray Other Interface USB 2.0 Micro-B plug Defibrillator Protection Yes Operating Temperature 0°C ~ 40°C (32°F ~ 95°F) Operating Humidity 15% ~ 85% relative humidity Operating Altitude Up to 3,000 m Weight 157.
Dimensions The physical dimensions of the DS-101 with stand are show bellow DS-101 Dimensions (Unit : mm) Page 81
The physical dimensions of the USB-BOX are show bellow.
Standards and compliance FCC warning This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications.
Alarm HR Synchronized Tone Maximum 83.0dB, Minimum 52.0dB Maximum 85.0dB, Minimum 32.
Respiration Method Frequency Characteristic Current Measurement Range Measurement Accuracy Waveform Size Selection Seep Speed Impedance Method 1.5Hz 100μA and below (at 64kHz ±5%) 0, 4 to 150bpm ±3rpm 1/5, 1/2, 1, 2, 4 (1 means 10mm/1Ω) 1.
Electromagnetic Compatibility The performance of this device under electromagnetic environment complies with EN 60601-1-2: 2007. Precautions for Safe Operation under Electromagnetic Influence If any sorts of electromagnetic wave, magnetic field, or static electricity exist around the device, noise interference or malfunction of the device may occur. If any unintended malfunction or noise occurs during monitoring, check the magnetic influence and take appropriate countermeasures.
ECG-Electrocardiographs l ME EQUIPMENT may show temporary DEGRADATION during ESD discharges. Within 10 s the ME EQUIPMENT shall resume normal operation in the previous operating mode, without loss of any operator settings or stored data, and shall continue to perform its intended function and maintain ESSENTIAL PERFORMANCE.
any operator settings or stored data, and shall continue to perform its intended function as described in the ACCOMPANYING DOCUMENTS . l When exposed to a conducted radio frequency voltage, via the POWER SUPPLY CORD, the ME EQUIPMENT shall continue to perform its intended function and maintain ESSENTIAL PERFORMANCE.. l PATIENT CABLES and TRANSDUCER cables are exempt from this requirement. SpO2 l ME EQUIPMENT shall comply with subclasses 6.2.1.
IEC 61000-3-3 Compliance to the FCC This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. For product available in the USA/Canada market, only channel 1~11 can be operated. Selection of other channels is not possible. This device is restricted to indoor use.
Troubleshooting General Can’t boot up and Power Light LED blanking Amber Cause System does not have enough battery capacity to boot up Solution Press power bottom after charge for 10min The display is dark, or cannot be seen clearly Cause The service life of the LCD backlight has expired. Solution The backlight needs to be replaced. Contact our service representative. The touch panel does not function properly.
Check the electrode attachment. Replace the electrodes. Check if the lead cable or relay cable is defective (wire break, etc.). The ECG waveform is displayed in baseline Cause 1 Electrode is detached. Solution Reattach the electrode. If the electrode contact is poor, replace the electrode. Cause 2 The lead cable is disconnected from the electrode terminal. Solution Securely connect the lead cable. Respiration "0" is displayed for respiration rate Cause The amplitude of the respiration waveform is too low.
Place a black or dark cloth over the sensor to avoid direct sunlight.When not using the sensor for measurement, avoid placing the sensor in light or unplug the sensor from the connector. SpO2 value is unstable Cause 1 There is excessive body motion from the patient which disables correct measurement. Solution 1 Have the patient lie still. Solution 2 Relocate the sensor, or change the sensor to which the body motion will have less influence. Cause 2 Sensor is exposed to light.
Check if the cuff is properly attached to the patient, or cuff size is correct. Cause 3 The air hose is disconnected. Solution Check if the air hose is tightly connected, and then measure again. If the same message is displayed again, air may be internally leaked. Contact our service representative.
Version History Page 94
