IEI Integration DS101WIFI Users Manual

Patient Monitor
DS-101 System
Ver.03
Operation Manual
* Before using the product,
please read this manual thoroughly.
* Store this manual where it can
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. Fukuda Denshi assumes no responsibility for any injury to anyone, or for any illegal any improper use of the product, which may result from failure to use this product in accordance with the instructions, cautions, warnings, or statement of intended use published in this manual.
Fukuda is registered trademark of Fukuda Denshi. Software in this product is Copyright 2016 Fukuda Denshi or its venders. All rights are reserved. Japan
copyright laws and international treaty provisions applicable protect the software worldwide. Under such laws, the licensee is entitled to use the copy of the software incorporated with this instruments as intended in the operation of the product in which it is embedded. The software may not be copied, decompiled, reverse-engineered, disassembled, or otherwise reduced to human-perceivable form. This is not a sale of the software or any copy of the software; all right, title, and ownership of the software remain with Fukuda Denshi or its vendors.
For information about any Fukuda Denshi product, call Fukuda Denshi technical Support:
USA +1 800 365 6668 +1 425 881 7734M Japan +81 3 3822 2171 United Kingdom +44 1483 728 065 China +86 01 6788 0514
Fukuda Denshi Co. Ltd. 3-39-4 Hongo Bunkyo Tokyo 113-8483 Japan
BriteMED Technology Inc. 3F., NO.306, 306-3, SEC. 1, DATONG RD., SIJHIH DIST., NEW TAIPEI CITY 221, TAIWAN
www.fukuda.com
Contents
Contents ......................................................................................................................................................... 1
Introduction ..................................................................................................................................................... 4
Intended Use ............................................................................................................................................... 4
Contraindications ........................................................................................................................................ 4
Symbols .......................................................................................................................................................... 5
Documentation symbols ............................................................................................................................. 5
Power symbols ............................................................................................................................................ 5
Connectivity symbols .................................................................................................................................. 5
Miscellaneous symbols ............................................................................................................................... 5
Screen elements ............................................................................................................................................. 6
About warnings and cautions ......................................................................................................................... 7
General warnings and cautions .................................................................................................................. 7
Controls, indicators, and connectors ............................................................................................................ 13
Setup............................................................................................................................................................. 15
Packing list ................................................................................................................................................ 15
Installation precautions ......................................................................................................................... 18
Mounting the system ............................................................................................................................. 18
Charging the system ............................................................................................................................. 19
DS-101 connection ................................................................................................................................ 20
NIBP relay horse Connection ................................................................................................................ 21
ECG cable connection .......................................................................................................................... 22
SpO2 cable connection ......................................................................................................................... 22
Power up the system ............................................................................................................................. 23
Replacing the battery ............................................................................................................................ 23
Start up ...................................................................................................................................................... 26
Power on screen ................................................................................................................................... 26
Patient login ........................................................................................................................................... 26
Patient registration ................................................................................................................................ 27
Default Setting ....................................................................................................................................... 27
Monitoring ..................................................................................................................................................... 29
Main Screen .............................................................................................................................................. 29
Large screen ............................................................................................................................................. 30
Wave ......................................................................................................................................................... 31
Dual channel mode ............................................................................................................................... 31
ECG cascade mode .............................................................................................................................. 31
ECG mode ............................................................................................................................................. 31
SpO2 mode ........................................................................................................................................... 32
Pause .................................................................................................................................................... 32
Full Disclosure ....................................................................................................................................... 32
Trend ..................................................................................................................................................... 33
Alarm History ......................................................................................................................................... 33
List ......................................................................................................................................................... 33
Event ..................................................................................................................................................... 33
Print ....................................................................................................................................................... 34
Save ...................................................................................................................................................... 34
Page 1
Menu ...................................................................................................................................................... 35
Menu ............................................................................................................................................................. 36
Display Mode ............................................................................................................................................ 36
Patient ................................................................................................................................................... 36
ALARM .................................................................................................................................................. 37
Review ................................................................................................................................................... 37
Parameter Set-up .................................................................................................................................. 42
Set-up .................................................................................................................................................... 44
Power Off ............................................................................................................................................... 48
Alarms ........................................................................................................................................................... 49
Alarm types ............................................................................................................................................... 49
Non-latching alarm .................................................................................................................................... 49
Alarm notification locations ....................................................................................................................... 49
Icons on the Main screen .......................................................................................................................... 50
Reset (pause or turn off) audio alarms ..................................................................................................... 51
Disable the alarm for a period ................................................................................................................... 51
Modify audio pause, alarm pause period .................................................................................................. 52
Adjust vital sign alarm limits ...................................................................................................................... 52
Default alarm limit ..................................................................................................................................... 53
Modify audio alarm notification ................................................................................................................. 53
Alarm Confirmation ................................................................................................................................... 54
On Main screen ......................................................................................................................................... 54
On Review screen ..................................................................................................................................... 54
Alarm message and situation ................................................................................................................... 55
Physiological alarms: Priority High ........................................................................................................ 55
Technical alarms: Priority Low............................................................................................................... 55
Patient monitoring ......................................................................................................................................... 57
ECG .......................................................................................................................................................... 57
ECG frame............................................................................................................................................. 57
ECG display........................................................................................................................................... 57
ECG Electrode Placement .................................................................................................................... 58
ECG Alarm............................................................................................................................................. 58
ECG Monitor Setting (Lead, Sensitivity, Filter, Pacing Detect) ............................................................. 59
RESP (Respiration) ................................................................................................................................... 60
RESP frame ........................................................................................................................................... 60
RESP display ......................................................................................................................................... 61
RESP Alarm ........................................................................................................................................... 61
RESP Setting ......................................................................................................................................... 61
SpO2 ......................................................................................................................................................... 62
SpO2 frame ........................................................................................................................................... 62
Pulse wave display ................................................................................................................................ 63
PR display ............................................................................................................................................. 63
SpO2 and PR Alarm .............................................................................................................................. 63
Measure SpO2 and pulse rate .............................................................................................................. 64
NIBP .......................................................................................................................................................... 65
NIBP frame ............................................................................................................................................ 65
NIBP measure window .......................................................................................................................... 66
NIBP Alarm ............................................................................................................................................ 66
Page 2
Select a cuff ........................................................................................................................................... 67
Cuff measurements ............................................................................................................................... 67
Position the cuff ..................................................................................................................................... 67
NIBP measurement ............................................................................................................................... 68
Take a manual NIBP measurement ...................................................................................................... 69
Interval NIBP measurement and other setting ...................................................................................... 69
Temperature .............................................................................................................................................. 70
Temperature frame ................................................................................................................................ 70
Temperature measurement display ....................................................................................................... 70
Thermometer ......................................................................................................................................... 70
Take a temperature in the Predictive mode .......................................................................................... 70
12 Lead ECG ............................................................................................................................................ 73
12 Lead ECG display ............................................................................................................................ 73
12 Lead ECG Alarm .............................................................................................................................. 73
12 Lead ECG Setting (Sensitivity, Filter, Pacing Detect) ...................................................................... 74
12 Lead ECG Electrode Placement ...................................................................................................... 75
12 Lead ECG Measurement ................................................................................................................. 75
12 Lead ECG Measurement Value ....................................................................................................... 77
Specification ................................................................................................................................................. 78
Specification .............................................................................................................................................. 78
Dimensions ............................................................................................................................................... 81
Standards and compliance ........................................................................................................................... 83
FCC warning ............................................................................................................................................. 83
Safety ........................................................................................................................................................ 83
Performance.............................................................................................................................................. 83
Sound Pressure ..................................................................................................................................... 83
ECG ....................................................................................................................................................... 84
Respiration ............................................................................................................................................ 85
SpO2 (Arterial Oxygen Saturation) ....................................................................................................... 85
NIBP (Non-Invasive Blood Pressure) .................................................................................................... 85
Hazardous Materials Disclosure ................................................................................... 錯誤! 尚未定義書籤。
Electromagnetic Compatibility ...................................................................................................................... 86
Precautions for Safe Operation under Electromagnetic Influence ....................................................... 86
EMC Guidance ...................................................................................................................................... 86
Troubleshooting ............................................................................................................................................ 90
Version History .............................................................................................................................................. 94
Page 3
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.
Before using the monitor, read the sections of the manual that pertain to your use of the monitor.
Intended Use
The DS-101 Patient Monitoring System is intended for monitoring single adult patient conditions by measuring/displaying/recording/alarming the patients parameters which include Electrocardiograms (ECG), Heart Rate (HR), Pulse Rate (PR), Respiration (RESP), Oxygen Saturation of Arterial Blood (SpO2), non-Invasive Blood Pressure (NIBP).
The device is intended to be operated by trained healthcare professionals in hospital environment, private practices, and during patient transport using battery power.
The device is also used as a data collection terminal with its equipped NFC Reader to read data, such as patient temperature data, from a passive NFC Tag. The NFC Reader interface does not provide any measurement functions.
The device is not intended to be used in Home, Ambulance, Airplanes, MRI environment, hyperbaric oxygen chambers, or near flammable anesthetic gasses.
Contraindications
This system is not intended to be used.
l On patients connected to heart/lung machines l On patients being transported outside a healthcare facility l Near an MRI machine l In a hyperbaric chamber l Near flammable anesthetics l Near electro-cauterization devices
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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
Alternating Current power present, battery is charging
Battery level
Connectivity symbols
Wireless LAN is not
connected.
Miscellaneous symbols
Meets essential requirements of European Medical Device
Directive 93/42/EEC
Monitor is plugged into Alternating Current power
present, battery fully charged
Battery power operation
Battery Low / Charge Battery
Wireless LAN is connected
Temperature Sensor touch area
Manufacturer
Defibrillation-proof Type CF applied parts
Recycle the products separate from other disposables.
Page 5
Defibrillation-proof Type BF applied parts
Screen elements
Navigation
HR
Sync Mark
SpO2
SpO2 Sync Bar
RESP
Resp Sync Bar
Lead off
Probe Off message
Finger Off message
NIBP
NIBP Oscillation Bar
Save
Auto Save On
Alarm and information messages
Alarm Off
Audio Pause Button
NIBP Auto Interval Timer
Alarm Pause & Count Down Timer
Audio Pause & Count Down Timer
Page 6
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. l Failure to understand and observe any warning statement in this manual could lead to
patient injury, illness, or death.
l Failure to understand and observe any caution statement in this manual could lead to
damage to the equipment or other property, or loss of patient data.
General warnings and cautions
WARNING Many environmental variables, including patient physiology and clinical application, can affect the accuracy and performance of the monitor. The clinician must verify all vital signs information before treating the patient. If there is any question about the accuracy of measurements, verify the measurement using another clinically accepted method.
WARNING Alarm limits are patient- or facility-specific. The clinician must set or verify alarm limits appropriate for each patient. Each time the monitor is powered on, you must check that the alarm settings are appropriate for your patient before you start monitoring.
WARNING The monitor is not intended for use during patient transport outside of the medical facility. Do not use the monitor to take measurements on any patient in transit.
WARNING Use only Fukuda Denshi approved accessories. Using unapproved accessories with the monitor can affect patient and operator safety and adversely affect product performance and accuracy. To ensure patient safety and optimal product performance, use only Fukuda Denshi recommended accessories and supplies (i.e., cuffs, horses, thermometer, SpO2 sensors, etc.) and use according to the accessory manufacturers direction for use.
WARNING Inaccurate measurement risk. Do not connect more than one patient to a monitor.
WARNING Inaccurate measurement risk. Dust and particle ingress can affect the accuracy of blood pressure measurement. Use the monitor in clean environments to ensure measurement accuracy. If you notice dust or lint build-up on the monitors vent openings, have the monitor inspected
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Power on the monitor and verify that the monitor functions normally
functions normally
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. Note If liquids possibly entered the monitor, remove the monitor from use until it has been properly dried, inspected, and tested by qualified service personnel.
5. Reinstall battery pack.
6.
before using it. If liquids enter the USB Box
1. Power down the monitor
2. Disconnect the USB connector.
3. Dry off excess liquid from the USB Box. Note If liquids possibly entered the USB Box, remove the monitor from use until it has been properly dried, inspected, and tested by qualified service personnel.
4. Connect the USB connector
Power on the monitor and verify that the monitor before using it. WARNING Safety risk. Damaged cords, cables, and accessories can affect patient and operator safety. Never lift the monitor by the power supply cord or patient connections. Routinely inspect the AC power cord, blood pressure cuff, SpO2 cable, and other accessories for strain relief wear, fraying, or other damage. Replace as necessary. WARNING Fire and explosion hazard. Do not operate the monitor in the presence of a flammable anesthetic mixture with air, oxygen, or nitrous oxide; in oxygen-enriched environments; or in any other potentially explosive environment. WARNING The monitor may not function properly if dropped or damaged. Protect it from severe impact and shock. Do not use the monitor if you notice any signs of damage. Qualified service personnel must check any monitor that is dropped or damaged for proper operation before putting the monitor back into use. WARNING Defective batteries can damage the monitor. If the battery shows any sign of damage or cracking, it must be replaced immediately and only with a battery approved by Fukuda Denshi. WARNING Electric shock hazard. Do not open the monitor or attempt repairs. The monitor has no user-serviceable internal parts. Only perform routine cleaning and maintenance procedures specifically described in this manual. Inspection and servicing of internal parts shall only be performed by qualified service personnel.
Page 8
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 Wall mounted equipment and accessories must be installed in accordance with accompanying instructions. Fukuda Denshi is not responsible for the integrity of any installation not performed by authorized Fukuda Denshi service personnel. Contact an authorized Fukuda Denshi service representative or other qualified service personnel to ensure professional installation for safety and reliability of any mounting accessory. WARNING Do not place the monitor in any position that might cause it to fall on the patient. WARNING Fukuda Denshi is not responsible for the integrity of a facilitys power. If the integrity of a facilitys power or protective earth conductor is in doubt, always operate the monitor on battery power alone when it is attached to a patient. WARNING Equipment damage and personal injury risk. When transporting the monitor on a mobile stand, properly secure all patient cables and cords to keep them clear of the wheels and to minimize trip hazards. WARNING For operator and patient safety, peripheral equipment and accessories that can come in direct patient contact must comply with all applicable safety, EMC, and regulatory requirements. WARNING All signal input and output (I/O) connectors are intended for connection of only devices complying with IEC 60601-1, or other IEC standards (for example, IEC 60950), as applicable to the monitor. Connecting additional devices to the monitor may increase chassis or patient leakage currents. To maintain operator and patient safety, consider the requirements of IEC 60601-1. Measure the leakage currents to confirm that no electric shock hazard exists. WARNING Equipment failure and patient harm risk. Do not cover the air intake or exhaust vents on the rear and base of the monitor. Covering these vents could cause overheating of the monitor or muffing of alarms. WARNING This equipment is not suitable for use in the presence of electro-surgery. WARNING Cross-contamination or nosocomial infection risk. Clean and maintenance the monitor on a routine basis according to your facilitys protocol and standards or local regulations. Thorough hand-washing before and after contact with patients greatly reduce the risk of cross-contamination and nosocomial infection. WARNING Do not modify this equipment without authorization of the manufacturer
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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. WARNING When using SpO2 function under the room temperature of 40 , SpO2,SpO2 test finger temperature will up to 43 Warning The performance of the AUTOMATED SPHYGMOMANOMETER can be affected by extremes of temperature, humidity and altitude Warning Connection to other equipment could result in previously unidentified risks to patients, operators or third parties. Fukuda Denshi is not responsible for the integrity of any installation or upgrade not performed by authorized Fukuda Denshi service personnel. Contact an authorized Fukuda Denshi service representative or other qualified service personnel to ensure professional installation for safety and reliability Warning Changes to other equipment could introduce new risks that require additional analysis, changes including
- changes in network configuration
- connection of additional items
- disconnection of items
- update of equipment
Warning Devices connect to the system shall fulfill 60601-1 requirement
WARNING Please do not absolutely installation and operation of the program other than Fukuda Denshi specified in the device. Normal operation of this equipment cannot be guaranteed. WARNING Please do not insert USB memory or other equipment while operating this device. When an application or installation starts automatically. Normal operation of this device can not be guaranteed Caution Japans Law restricts this monitor to sale, distribution, or use by or on the order of a physician or licensed healthcare professional. Caution Electromagnetic interference risk. The monitor complies with applicable domestic and international standards for electromagnetic interference. These standards are intended to minimize medical equipment electromagnetic interference. Although this monitor is not expected to present problems to other compliant equipment or be affected by other compliant devices, interference issues still may occur. As a precaution, avoid using the monitor in close proximity to other equipment. In the event that equipment interference is observed, relocate the equipment as necessary or consult manufacturers direction for use. Caution Use only a Class I (grounded) AC power supply cord for powering this monitor.
Caution Do not use a long press of to power down the monitor when it is functioning normally. You will lose patient data and configuration
Page 10
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. Caution Use only the Fukuda Denshi USB client cable to connect a USB Box to the USB port. Caution If the touchscreen is not responding properly, refer to the troubleshooting section. If the problem cannot be resolved, discontinue use of the monitor and contact an authorized Fukuda Denshi service center or qualified service personnel. Caution Summation of leakage currents when several items of ME EQUIPMENT are interconnected Caution The electrocardiograph incorporates a means to protect the patient against burns when used with HIGH FREQUENCY(HF) SURGICAL EQUIPMENT Caution Cleaning and maintenance procedures l When cleaning the touch panel, never use strong-acidic cleaning
solution.
l A special coating is applied to the surface of the touch panel. Do not
wipe the surface with a cloth or gauze with coarse texture. Wipe the surface with an eyeglass cleaning cloth.
l Clean the equipment frequently so stains can be removed easily. l To prevent injury, it is recommended to wear gloves when cleaning
the equipment.
l Do not allow liquids or cleaning solution to enter the equipment or
connectors.
l Do not use organic solvents, thinner, toluene and benzene to avoid
damaging the resin case.
l Do not polish the housing with abrasive or chemical cleaner. l When sterilizing the entire room using a spray solution, pay close
attention not to have liquids get into the equipment or connectors, The surface resin coating may be damaged, resulting in discoloration, scratches, or other problems. Example: Do not use chemical cloth, scrub brush, abrasive, polishing powder, hot water, volatile solvent and chemicals (cleanser, thinner, benzine, benzol, and synthetic detergent for house and furniture), or sharp-edged tools.
l Do not open the housing. l Avoid alcohol or other liquids from getting into the equipment. l For safe operation of the equipment, regular inspection and
maintenance are required. Once a year, check all cables, devices, and accessories for damage, earth impedance, earth and leakage currents, and all alarm functions. Also, ensure that all safety labels are legible. Maintain a record of these safety inspections.
Page 11
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. l When any connector or cable shows signs of deterioration. Caution To prevent intrusion of computer viruses, please use this system in the closed network except for sending mail Caution When using this system on a wireless network, please set the connected device by MAC address on access point and router. Caution When using this system on a wireless network, please set the connected device by MAC address on access point and router.
Page 12
Controls, indicators, and connectors
No. Feature Description
1 Light bar Provides a visual alarm with red and blue LEDs. 2 Light bar Provides a synchronized heartbeat with green LEDs. 3 LCD screen
4 Power switch Power-on/Standby switch. 5 NIBP connector Self-contained module for easy replacement. 6 ECG connector
7 SpO2 connector
8 NFC touch area
9 Power Light
1280 x 800 pixels color touchscreen provides a graphical user interface.
Self-contained module for easy replacement. Supports 3lead or 10lead ECG cables.
Self-contained module for easy replacement. Supports Clip-type or Tape-type SpO2 sensors.
Receive body temperature by thermometer into contact with this place
The LED indicates the charging status
l Green: Power on (Both AC and battery powered) l Amber: The battery is charged. l Amber blanking: The battery is charging. l Black: Power off without AC powered
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② ③ ④ ⑥ ⑦ ⑤
No. Feature Description
1 Speaker
Provides an audible Alarm (low or high) and synchronized heartbeat sound.
2 Handle 3 AUX-1 connector
Provides a connection to secure USB-memory for software upgrades.
4 AUX-2 connector
Provides a connection to optional medical devices.
5 IO connector Connect to display module 6 Power connection Provides an external AC power connection. 7 IO connector Connect to Main module.
Page 14
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.
Packing list
The DS-101 is shipped with the following components:
Note If any of these items are missing or damaged, contact the distributor
or sales representative immediately.
Quantity Description Model Name Image DS-101
1 Panel PC DS-101
1 AC adaptor 3P ADP-101
1 Power cord
USB-BOX
1 Multiport Data
Collector
HS-101
Page 15
Reuseable(3m) Clip
1 ECG CABLE (3
1 USB Cable USB-101
Stand
1 Stand 101STAND
Accessory
1 SpO2 sensor
type
SPO-10RAC3M
CMO-101HR3
Leads)
1 NIBPcuff for adult M
(23-33 cm)
CUF-101M
(30 to 280mmHg)
1 NIBP relay horse OA-101AP
Page 16
Accessory (Option)
SpO2 sensor
ECG CABLE
1
Reuseable(3m) Tape type
1
12Leads (3m)
1 NIBP cuff for adult L
(31-43 cm)
(30 to 280mmHg)
SPO-11RAT3M
CMO-101HR12
CUF-101L
1 NIBPcuff for adult S
(17-25 cm)
CUF-101S
(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. Do not install the instrument in a chemical storage area or where gas is generated.
Mounting the system
The DS-101 came with a USB-BOX and a stand. To mount the USB-BOX and the stand, follow the steps below.
1. Secure the USB-BOX to the stand with four flat-head retention screws.
2. Secure the stand to the rear panel of the DS-101 with four retention screws.
Page 18
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.
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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. Please follow the detailed instruction below to connect
the cables for patient monitoring.
Page 20
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.
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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. If any abnormality is observed, immediate proper action, such as stopping the operation of the instrument, should be taken for the safety of the patient..
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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.
DS-101 Status: Power On or Sleep Power LED Status
Green Power on Solid amber The battery is fully charged Slowly flash in amber The battery is being charged LED off Power cable disconnected
DS-101 Status: Power Off Battery Power Status
Lower than 5% The power LED flash rapidly in amber after long-pressing the power button. The
battery power is too low to power up the DS-101.
5% ~ 10% The power LED light up in green after long pressing the power button. The
DS-101 can be powered on to access the software application.
Higher than 10% The power LED light up in green after long pressing the power button. The
DS-101 can be powered on to access the software application. When the power is lower than 10%, the DS-101 will shut down automatically.
Replacing the battery
This section describes how to replace the battery if necessary.
1. Remove the two retention screws that secure the battery access panel. Then, lift the panel to remove it.
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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.
Page 24
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.
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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. l Same Patient: Return to the Monitor Mode page or the Large Mode page to monitor the
current patient.
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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 Item Detail Default
ECG Monitor
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ECG Lead I, II, III II Sensitivity x0.5, x1, x2, x4 x1
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