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
Intended Use ............................................................................................................................................... 4
Power symbols ............................................................................................................................................ 5
Screen elements ............................................................................................................................................. 6
About warnings and cautions ......................................................................................................................... 7
General warnings and cautions .................................................................................................................. 7
Controls, indicators, and connectors ............................................................................................................ 13
Packing list ................................................................................................................................................ 15
Power up the system ............................................................................................................................. 23
Replacing the battery ............................................................................................................................ 23
Start up ...................................................................................................................................................... 26
Power on screen ................................................................................................................................... 26
Main Screen .............................................................................................................................................. 29
Large screen ............................................................................................................................................. 30
Full Disclosure ....................................................................................................................................... 32
Alarm History ......................................................................................................................................... 33
List ......................................................................................................................................................... 33
Save ...................................................................................................................................................... 34
Page 1
Menu ...................................................................................................................................................... 35
Menu ............................................................................................................................................................. 36
Power Off ............................................................................................................................................... 48
On Main screen ......................................................................................................................................... 54
On Review screen ..................................................................................................................................... 54
Alarm message and situation ................................................................................................................... 55
Physiological alarms: Priority High ........................................................................................................ 55
Select a cuff ........................................................................................................................................... 67
Position the cuff ..................................................................................................................................... 67
Take a manual NIBP measurement ...................................................................................................... 69
Interval NIBP measurement and other setting ...................................................................................... 69
Temperature .............................................................................................................................................. 70
Temperature frame ................................................................................................................................ 70
Temperature measurement display ....................................................................................................... 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
Standards and compliance ........................................................................................................................... 83
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 patient’s 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 it’s 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
Page 4
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 manufacturer’s
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 monitor’s vent openings, have the monitor inspected
Page 7
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 facility’s
power. If the integrity of a facility’s 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 facility’s
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
Page 9
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 Japan’s 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 manufacturer’s 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
Page 13
② ③ ④ ⑥ ⑦ ⑤
①
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.
Page 19
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.
Page 21
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..
Page 22
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.
Page 23
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.
Page 25
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:
lAdmin 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.
Page 26
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
Page 27
ECG Lead I, II, III II
Sensitivity x0.5, x1, x2, x4 x1
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