IEI Integration DS101WIFI Users Manual

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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. 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.

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 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

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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.

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Defibrillation-proof Type BF applied parts

Screen elements

Navigation

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

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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

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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.

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.

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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

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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 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

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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.

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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

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

Reuseable(3m) Tape type

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.

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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.

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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

Filter Diag., Monitor, Drift Cut Drift Cut Hum Filter ON, OFF ON Pacing Detect ON, OFF OFF

ECG 12 leads

Sensitivity x0.25, x0.5, x1, x2, x4 x1 Low Cut Filter 0.05Hz, 0.15Hz, 0.3Hz 0.05 High Cut Filter 30Hz, 150Hz, 250Hz, OFF OFF Hum Filter ON, OFF ON Pacing Detect ON, OFF OFF

NIBP

Pressure Pre-set 120, 150, 180, 200 180 Pressure Limit 150, 200, 250, 300 250 Auto Interval ON, OFF OFF

RESP

RESP Lead I, II II Sensitivity x0.2, x0.5 x1, x2, x4 x1

Patient admit-discharge

Item Default

Birth

Height

Weight

Year 1970

Month 1

Day 1 0 0

Alarm Limit

Parameter Unit Lower Limit Upper Limit

HR/PR

SpO2

Resp

NIBP Sys

NIBP Dia

BPM 40 120

% 90 100

/min 5 30 mmHg 80 180 mmHg 40 100

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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:

l HR: heart rate. A heart icon and a beep will be generated every time the ECG peak

is detected. The numbers under bpm on the right indicate the normal range of heart rate. If the heart rate exceeds the normal range, the warning sound and icon will be triggered.

l PR: pulse rate (displayed when SpO2 is selected without ECG channel). A beep will

be generated every time the SpO2 peak is detected.

l SpO2: oxygen saturation

¡ The five blocks on the left show the level of heart beat strength. The three

blocks on the top show the level of the signal strength.

¡ The number beside the percentage sign (%) indicates the normal range. If the

oxygen saturation exceeds the normal range, the warning sound and icon will be triggered.

l NIBP: blood pressure

¡ The five blocks on the left show the strength level of the blood flow ¡ Time: the time at which the checkup is completed ¡ Sys in orange: Systolic pressure. The small number on the side indicates the

normal range of systolic pressure. If the systolic pressure exceeds the normal 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.

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l RESP: the number of breaths l 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. A heart icon and a beep will be generated every time the ECG peak

is detected. The numbers under bpm on the right indicate the normal range of heart rate. If the heart rate exceeds the normal range, the warning sound and icon will be triggered.

l PR: pulse rate (displayed when SpO2 is selected without ECG channel). A beep will

be generated every time the SpO2 peak is detected.

l SpO2: oxygen saturation

¡ The five blocks on the left show the level of heart beat strength. The three

blocks on the top show the level of the signal strength.

¡ The number beside the percentage sign (%) indicates the normal range. If the

oxygen saturation exceeds the normal range, the warning sound and icon will be triggered.

l RESP: the number of breaths. The block on the left blinks every time a breath is

detected.

l TEMP: press TEMP to enter the page with detail temperature information l NIBP: blood pressure

¡ The block on the left blinks every time blood flow is detected. ¡ Sys in orange: Systolic pressure. The small number on the side indicates the

normal range of systolic pressure. If the systolic pressure exceeds the normal

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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.

Wave

Dual channel mode

The upper waveform is ECG signal and the lower one is pulse wave.

ECG cascade mode

Display ECG waveform in two areas.

ECG mode

If ECG waveform is displayed in a bigger area, user can change waveform amplitude to see more detail.

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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.

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Full disclosure begins halfway corresponding to the time (second) when pressing the Full

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

Event

User can check all latest events in a list.

If there are ECG/SpO2/NIBP/Respiration/Temperature/Manual operations, those events will be recorded on the timescale.

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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.

Save

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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. Contact an authorized Fukuda Denshi service representative or other qualified service personnel to ensure professional installation for safety and reliability

Once the Save button is clicked, the button is disabled and the color is changed to gray. The system will start storing the image.

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.

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Display Mode

The Display page allows users to select monitor mode and waveform display mode. The options include:

l Mode Select:

¡ Main Screen ¡ Large Screen ¡ 12 Lead ECG

l Monitor Wave:

¡ Dual Channel ¡ ECG ¡ ECG Cascade

¡ SpO2 l BACK: go to Menu page. l EXIT: exit the Menu page and go back to the Main Screen.

Patient

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The Patient page allows users to input patient information, delete patient record or tentative discharge.

ALARM

Review

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.

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.

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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 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 l 1/13, 1/14, 1/15, 1/16: change Timescale range. l Print Page: print full disclosure waveform. l BACK: go to Menu page l EXIT: go to Main Screen.

Trend

The Trend page displays ECG, SpO2, temperature trend and the time of NIBP measurement.

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The Trend page also contains the following buttons:

l : go back 6 hours.

l : go forward 6 hours.

l : jump to the end. 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 l 1/13, 1/14, 1/15, 1/16: change Timescale range. l BACK: go to Menu page l EXIT: go to Main Screen.

Alarm History

The Alarm History page displays heart rate, SpO2, NIBP, respiration alarm time and related data. If you double click the alarm column, it will lead to the Review page.

The Alarm History page also contains the following buttons:

l : jump to previous 10 items.

l : jump to next 10 items.

l : jump to the end. l Timescale :

l Green bar: there are ECG waveforms in the database. l Yellow dots: there are events at that time l Red dots: there are alarms triggered at that time l 1/13, 1/14, 1/15, 1/16: change Timescale range. l Print Page: print current list. l Print All : print all alarm list (the maximum number is 100) l BACK: go to Menu page

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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 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 l 1/13, 1/14, 1/15, 1/16: change Timescale range. l Print Page: print current list. l Print All : print all alarm list (the maximum number is 400) l BACK: go to Menu page l EXIT: go to Main Screen.

Event

The Event page shows marks of ECG, SpO2, NIBP, RESP, temperature and Manual operation events.

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The Event page also contains the following buttons:

l : go back 1 hour.

l : go forward 1 hour.

l : jump to the end. 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 l 1/13, 1/14, 1/15, 1/16: change Timescale range. l BACK: go to Menu page l EXIT: go to Main Screen.

Review

The Review page will be shown when the user double clicks an item from the list of the Alarm History page or the List page. The texts on the right side indicate the occurred time and the name of the selected item. Take the following figure as an example: HR Alarm of List means the information shown on the left is the content of the HR alarm in the List page, the 7th item of 16 items from the list.

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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. l Sensitive: adjust ECG amplitude l Filter: select filter l Hum Filter: disable or enable hum filter l Pacing Detect: disable or enable pacing detect l BACK: go to Menu page. l EXIT: go to Main Screen.

ECG 12 Leads

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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. l Auto Interval:

¡ OFF: Disable

¡ ON: Enable auto measurement function. User can control Up & Down to adjust

interval. A countdown timer will be displayed on the top of the Main Screen.

l BACK: go to Menu page. l EXIT: go to Main Screen.

RESP

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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

System

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. l BACK: go to Menu page. l EXIT: go to Main Screen.

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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. For demonstration purpose adding “Demo Wave” mode

l Setting for new admit: For adding new user, using “Factory default” setting or “Current

Setting” for new user, able to click “Setting info” has a summary page for all the settings as below picture

l Language: Select proper language for use, currently support English only l Version: Click Version button to have the related information including hardware and

software as below picture

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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.

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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

l Sleep Mode

l Exit Software

Press “Standard ShutDown” button.

DS-101 turns off

Press “Sleep mode Shut Down” button.

DS-101 enters sleep mode. Press the power button to start up quickly.

Press button.

Entering the password and return key, ends DS-101 and returns to Windows.

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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 Priority Color Alarm audio tone Heart Rate, Respiration rate, SpO2, NIBP, or

Pulse rate limit exceeded Some technical alarms 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. However, alarms that occurred in the past can be confirmed in the alarm history screen. If there is an unconfirmed alarm, change the Alarm History button to red and inform it

Alarm notification locations

WARNING If you are relying on visual alarm notifications, maintain a clear line of sight with the monitor. If you are relying on audio alarm notifications, ensure that you can hear audio alarms from where you are. Set the

volume as needed considering the environment and ambient noise levels. LED light bar The light bar on the top of the monitor illuminates as follows:

l Flashing red for high priority alarms l Constant blue for low priority alarms

Main screen

High Red 5-pulse tone

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Main screen notifications Notification Description Information area

Parameter area

Menu 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)

Display alarm information with red (high priority) or blue (low priority) frame.

If multiple alarms are active, the most recent alarm message appears.

You can confirmation each alarm on the alarm history screen. Alarm History button changes color to red. By pressing this button

you can confirmation alarm on the alarm history screen, and the button changes color to black.

Icons on the Main screen

Icons in the parameter area Icon Name and status

WARNING Alarm does not work during 12-lead ECG measurement. Also,

the countdown timer of Alarm Pause is displayed from the start of

monitoring and returning to monitoring from the 12-lead ECG

measurement during which the alarm will not operate

Icons in the information area Icon Name and status

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Alarm off. No visual or audio alarms occur for this limit.

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

l Flashing red LED and 5-pulse tone sound. l Alarm message frame appears on parameter area. l Sound Pause button appears on information area.

2. Audio paused

l Touch button. l Audio alarm stops but flashing LED continues.

l Audio pause count down timer appears. l Investigate the cause of the alarm and deal with it l Change the alarm limits if necessary l Alarm messages will not disappear unless Vital signs returns within alarm limits

Disable the alarm for a period

You can disable the alarm for a certain period of time

1. Go to the Alarm setting screen.

l Touch the Menu button on Main screen. l Touch the Alarm setting button on Menu screen.

2. Disable the alarm for a period. l Touch the Alarm Paused key

If the alarm is off, the icon on the Main screen in the parameter area.

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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.

l Touch the Menu button on Main screen. l Touch the Alarm setting button on Menu screen.

2. Adjust vital sign alarm limits. l To adjust a limit: Enter the desired upper and lower alarm limits using the up/down

arrow key by touch the Lower/Upper limit button.

l To turn alarm off: Touch the parameter button for which you want to turn off the

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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.

Parameter Unit Lower Limit Upper Limit

HR/PR

SpO2

Resp

NIBP Sys

NIBP Dia

NOTE Whether the alarm limit at patient admit to the default value or to use the previous

patient value depends on System setting

BPM 40 120

% 90 100

/min 5 30 mmHg 80 180 mmHg 40 100

Modify audio alarm notification

You can modify the volume of all audio alarm.

WARNING The alarm volume should be loud enough for you to hear it from where you are. Set the volume considering the environment and ambient noise level.

l Touch the Menu key. l Touch the Sound/List key. l On the Sound/List screen, modify alarm volume level.

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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. You can check up to 200 alarms with the arrow keys

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4. Double-click on the alarm time to check the waveform at that time.

Alarm message and situation

Physiological alarms: Priority High

Alarm messages Display area Situation HR XX hh:mm ECG frame Heart Rate alarm limit exceeded at hh:mm RESP XX hh:mm REP frame Resp rate alarm limit exceeded at hh:mm SpO2 XX hh:mm SpO2 frame SpO2 alarm limit exceeded at hh:mm NIBP XX/YY hh:mm NIBP frame NIBP alarm limit exceeded at hh:mm

Technical alarms: Priority Low

Alarm messages Display area Situation Lead-off ECG frame

Lead-off 12L ECG screen

Lead-off RESP frame

Probe-off SpO2 frame SpO2 sensor is not connect

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ECG lead is not connect or 1 or more electrodes out of the body

ECG lead disconnect or 1 or more electrodes out of the body

ECG lead disconnect or 1 or more electrodes are out of the body

Finger-off SpO2 frame SpO2 sensor is out of finger

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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. l When either of If HR goes out of the alarm range, the red LED flashes, an alarm tone

sounds and an alarm message is displayed.

ECG display

The ECG waveform is always display on the bottom of the Main screen, expect of SpO2 only modes.

ECG & SpO2 mode

ECG mode

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ECG cascade mode

l ECG lead is displayed on the left side of the screen. l Calibration bar linked to the ECG sensitivity is displayed on the left side of the screen. l 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. To set the Hart Rate alarm limits, use the arrow key on the right side of the screen to follow these steps:

l Touch the Lower Limit key, change limit using arrow key. l Touch the Upper Limit key, change limit using allow key. l Alarm limit is changed immediately.

5. If you want to turn off the alarm, press the HR/PR key to make it black.

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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. 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.

6. Select the Filter in accordance with the intended use.

l Diag.: Use when observing the ST change due to ischemia. l Monitor: Usually, use this mode. l Drift Cut: Select when using in an environment with a lot of ac noise. Waveform

distortion increases.

Note This DS-101 does not have arrhythmia detection. Please carefully observe the patient's condition by using upper / lower limit alarm of Heart Rate.

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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.

WARNING PACEMAKER PATIENTS. See this manual for disclosure of the pacemaker pulse rejection capability of this instrument” WARNING Heart Rate may continue to count the pacemaker rate during occurrences of cardiac arrest or some arrhythmias. Do not rely entirely upon rate meter alarms. Keep pacemaker patients under close surveillance

RESP (Respiration)

RESP frame

From the RESP frame, you can measure Respiration Rate (RR). Located in the center of the Main screen, the RESP frame contains data and features

relevant to Respiration. Main Screen

Large Screen

l You can check the Respiration Rate l You can see the synchronized chest motion with RESP wave (Main Screen) or 5 level

bar (Large Screen).

l You can see Respiration Rate alarm limits. (Upper and Lower), right of the RR.

l If alarm is off, you can see alarm off mark. l When either of If RR goes out of the alarm range, the red LED flashes, an alarm tone

sounds and an alarm message is displayed.

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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:

l Touch the Lower Limit key, change limit using arrow key. l Touch the Upper Limit key, change limit using allow key. l Alarm limit is changed immediately.

5. If you want to turn off the alarm, press the Resp key to make it black.

RESP Setting

1. Touch the Menu key.

2. Touch the ECG Monitor key.

3. You can configure the lead, sensitivity.

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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. To detect respiratory rate, a waveform of 3 mm or more is required. Adjust the sensitivity

within the range not picking up heartbeat.

SpO2

SpO2 frame

From the SpO2 frame, you can measure the SpO2% and Pulse Rate (PR). Located in the under of ECG frame on the Main screen, the SpO2 frame contains data and

features relevant to SpO2. (Main Screen and Large Screen) Main Screen Alarm ON Alarm OFF

l You can check the SpO2 %

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l You can see the oximetry pulse volume, displayed as a vertical bar graph. l You can see SpO2 % alarm limits. (Upper and Lower), right of the SpO2 %

l If alarm is off, you can see alarm off mark. l When either of If SpO2 % goes out of the alarm range, the red LED flashes, an alarm

tone sounds and an alarm message is displayed.

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 Amplitude of the pulse wave is automatically adjusted. l 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.

HR display PR display

Note When the pulse only mode is selected, ECG and RESP related alarm

SpO2 and PR Alarm

1. Touch the Menu key.

2. Touch the Alarm Setting key.

3. SpO2 % is displayed in the SpO2 key and the green line on the bar graph.

4. To set the SpO2 alarm limits, use the arrow key on the right side of the screen to follow these steps:

l Touch the Lower Limit key, change limit using arrow key. l Touch the Upper Limit key, change limit using allow key. l Alarm limit is changed immediately.

5. In the pulse only mode, use the arrow on the right side of the screen to set the alarm limits of the Pulse Rate

6. If you want to turn off the SpO2 alarm, press the SpO2 key to make it black.

7. If you want to turn off the PR alarm, press the HR/PR key to make it black.

are turned off. (Including ECG and RESP lead off warning)

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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.

WARNING The accuracy of the SpO2 measurement can be affected by any of the following: l The presence of significant amounts of dysfunctional hemoglobin,

such as carboxyhemoglobin or methemoglobin

l The presence of concentrations of some intravascular dyes, sufficient

to change the patient’s usual arterial pigmentation

l Patient movement l Patient conditions such as shivering and smoke inhalation l Painted nails l Poor oxygen perfusion l Anemia or low concentrations of hemoglobin l Hypotension or hypertension l Severe vasoconstriction l Shock or cardiac arrest l Venous pulsations or sudden and significant changes in pulse rate l Proximity to an MRI environment l Moisture in the sensor l Excessive ambient light, especially fluorescent l Wrong sensor or sensor too tight

1. Verify the SpO2 sensor cable is connected to the monitor.

WARNING Patient injury risk. The SpO2 sensor and extension cables are intended only for connect to pulse oximetry equipment. Do not attempt to connect these cables to a PC or any similar device. Always follow the sensor manufacturer’s directions for use for care and use of the SpO2 sensor.

2. Clean the application site. Remove anything, such as nail polish, that could interfere with sensor operation.

Note Do not use disposable sensors on patients who have allergic

reactions to the adhesive.

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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.

Note A range of different sensors is available for different patient

sizes and measurement sites. Consult the SpO2 sensor manufacturer’s direction for use to select the correct sensor based on the patient’s weight.

4. Confirm the monitor display SpO2 and pulse rate data within 15 seconds of being connected to a patient.

WARNING Patient injury risk. Incorrect application or a long duration of use of an SpO2 sensor may cause tissue damage. Inspect the sensor site periodically as directed in the sensor manufacturer’s direction for use.

During an SpO2 measurement, the displayed pulse rate is derived from the SpO2 sensor. If SpO2 is not available, the pulse rate is derived from NOBP.

Detaching the sensor during an SpO2 measurement in Monitor mode triggers an alarm. If SpO2 is being measured continuously on a patient for an extended period, change the

sensor location at least every three hours or as indicated by the sensor manufacturer’s direction for use.

NIBP

NIBP frame

From the NIBP frame, you can measure blood pressure. Located in the upper right corner of Main screen, the NIBP frame contains data and features

relevant to noninvasive blood pressure measurement. Main Screen Alarm ON Alarm OFF

Large Screen

l The frame can display Systolic and Diastolic measurements. l You can see blood pressure alarm limits. (Upper and Lower)

l If alarm is off, you can see alarm off mark.

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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 The frame can display Systolic and Diastolic measurements. l You can see blood pressure alarm limits. (Upper and Lower) l You can see previous NIBP measurement data. l When blood pressure is measured, a graph of cuff pressure and pulsation is displayed.

NIBP Alarm

1. Touch the Menu key.

2. Touch the Alarm Setting key.

3. Sys Dia is displayed in the NIBP key and the green line on the bar graph.

4. To set the NIBP alarm limits, use the arrow key on the right side of the screen to follow these steps:

l Touch the Lower Limit key, change limit using arrow key. l Touch the Upper Limit key, change limit using allow key. l Alarm limit is changed immediately.

5. If you want to turn off the NIBP alarm, press the NIBP key to make it black.

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Select a cuff

The monitor uses the oscillometric method to determine blood pressure; therefore, if the cuff extends to the antecubital fossa (bend in the elbow), you can still acquire an accurate blood pressure reading.

Before taking an NIBP measurement, follow these steps to select the appropriate cuff for the patient.

1. Measure the circumference of the patient’s bare upper arm. Midway between the elbow and shoulder.

2. Choose the appropriate cuff size based on the circumference measurement. If the circumference of the patient’s arm falls between two cuff sizes, use the large cuff size.

3. Cuff size can also be selected using the circumference index at the end of the cuff. The size of the cuff is fit if the patient's upper arm's end is between the two arrows of the index mark

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.

4. Wrap the cuff by placing the arterial index mark on the inside of the patient's bare upper arm.

Cuff measurements

The following tables provide measurement for BriteMed pressure cuffs.

Cuff Circumference (cm) ADULT-S 17.0 – 25.0 ADULT-M 23.0 – 33.0 ADULT-L 31.0 – 43.0

Position the cuff

Note The monitor and cuffs were validated using the bare upper arm site.

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generated through the blood pressure cuff or through SpO2 are subject

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. Do not place the cuff on any area where circulation is compromised or on any extremity used for intravenous infusions. Do not use an SpO2 finger clip sensor and a blood pressure cuff simultaneously on the same limb. Doing so many causes a temporary loss of pulsation flow, resulting in either no reading or an inaccurate SpO2 or pulse rate until the flow returns. WARNING The blood pressure cuff must be properly positioned to ensure blood pressure accuracy and patient safety. Wrapping the cuff too loosely (preventing proper inflation) may result in inaccurate NIBP readings. Caution If a site other than the bare upper arm is used, the blood pressure measurements may be different. It is important to document the alternate site on the patient record. Caution To minimize inaccurate measurement, limit patient movement during an NIBP measurement cycle.

Before taking an NIBP measurement, follow these steps and select the appropriate cuff for the patient.

1. Comfortably seated, Legs uncrossed, Feet flat on the floor, Back and arm supported, to relax as much as possible and not talk during the measurement procedure. Recommend to have 5 min elapse before the first reading is taken

2. Position middle of the CUFF at the level of the right atrium of the heart

3. Wrap the cuff snugly so that there is room for no more than two fingers between the cuff and the patient’s bare upper arm.

4. Position the alignment mark on the cuff directly over the brachial artery.

5. Ensure that the blood pressure tubing has no kinks or twists.

NIBP measurement

The monitor enables you to take manual and automatic NIBP measurement

WARNING NIBP readings may be inaccurate for patients experiencing moderate to severe arrhythmia WARNING Inaccurate measurement risk. Pulse rate measurements

artifact and might not be as accurate as heart rate measurements generated through ECG or through manual palpation. Caution Inaccurate measurement risk. Any external compression of the blood pressure hose or cuff may cause system errors or inaccurate measurements.

At the start of a measurement, the monitor inflates the cuff to the appropriate level. In the NIBP frame or NIBP measure window, the cuff display shows the cuff inflation pressure while the blood pressure measurement is in progress.

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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

WARNING Patient injury risk. Never install Luer Lock connectors on Fukuda Denshi blood pressure cuff tubing. Using these connectors on blood pressure cuff tubing creates the risk of mistakenly connecting this tubing to a patient’s intravenous line and introducing air into the patient’s circulatory system. Caution Inaccurate measurement risk. Any external compression of the blood pressure hose or cuff may cause system errors or inaccurate measurements.

1. Properly size the blood pressure cuff and position it around the patient’s bare upper arm.

2. Touch Start/Stop to take a measurement.

Interval NIBP measurement and other setting

The monitor can take NIBP measurements automatically based on intervals you choose. The NIBP setting screen provides interval features.

1. Touch the MENU key

2. Touch the NIBP key

3. Select Pressure Pre-set. The cuff inflates to this pressure for the first time. When it can not be measured, the cuff inflates to 50 mmHg higher pressure.

4. Select Pressure Limit. The cuff does not inflate above this pressure.

5. If you want interval measurement touch Auto Interval ON key.

6. When the Auto Interval is turned on, the interval setting key is displayed and can be set using the up and down keys

7. Turn on Interval measurement, and when you exit the setting screen the interval timer starts counting down

8. When the countdown becomes 0, blood pressure is measured.

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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. Located in the middle right of the Main screen, or center of Enlarge screen, the temperature

frame contains data and features relevant to temperature measurement. Main Screen Enlarge Screen

Temperature measurement display

The frame can display temperature in Celsius or Fahrenheit. You can configure the default view in Settings. And display measurement time also.

Thermometer

The monitor receives thermometer data via NFC Thermometer calculates patient's body temperature with thermistor and prediction algorithm.

Take a temperature in the Predictive mode

WARNING Inaccurate measurement risk. To ensure optimal accuracy, always confirm that the correct mode and site are selected.

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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. Insert the probe into a new probe cover.

3. Hold the probe tip in place at the measurement site. l For oral temperatures, place the probe tip under the patient’s tongue on either side of the

mouth to reach the sublingual pocket and ask the patient to close his/her lips.

l For axillary temperatures, lift the patient’s arm so that the entire axilla is easily seen and

place the probe tip as high as possible in the mid-axilla. Verify that axillary tissue completely surrounds the probe tip and place the arm snugly at the patient’s side.

4. While the measurement is taking place, the thermometer sounds a tone.

5. The thermometer sounds a burst tone when the final temperature is reached (in

approximately 6 to 15 seconds).

6. Touch the temperature frame, temperature measurement screen displayed.

7. Touch the thermometer to NFC area of the monitor

NFC area

8. Sounds when the monitor receives temperature data from the thermometer. The temperature measure screen displays the temperature.

9. You can check the previous temperature data on record frame.

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10. Touch exit to return Main screen, and temperature frame displays the temperature.

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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.

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12 Lead ECG Setting (Sensitivity, Filter, Pacing Detect)

1. Touch the Menu key.

2. Touch the ECG 12 Leads.

3. You can configure the sensitivity, filter, and pacing detect.

4. 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 0.05Hz: This is standard for measurement ECG. l 0.15Hz: Select when using 12-lead ECG as monitoring instead of diagnosis,

draw less baseline drift.

l 0.3Hz: Select when patient's body movements are large, reduce the baseline

drift.

l 0.3Hz: Select when using in an environment with a lot of ac noise. Waveform

distortion increases.

6. Select the High Cut Filter in accordance with the intended use.

l OFF: This is standard for measurement ECG. l 250Hz: Select this will reduce fine noise on the waveform l 150Hz: Select when patient's EMG noise is large, reduce the EMG noise. l 30Hz: Select when using in an environment with a lot of ac noise. Waveform

distortion increases.

7. Turn on the Hum Filter with the intended use.

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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. Monitor the 12L ECG.

2. If you want to go back to Monitoring mode, Touch EXIT button.

3. Display monitoring condition with bottom area.

4. You can change the sensitivity by touch the Gain button

5. Touch ANALYZE key when ECG waveform stabilizes.

6. Measured value is displayed after taking in the waveform for 10 seconds

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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.

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9. Print image is as follows.

12 Lead ECG Measurement Value

You can see 12 lead ECG measurement value are as follows. HR, QRS axis, P dur, QRS dur, QTc int, P axis, T axis, PR int, QT int, RV5+SV1

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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 Brightness (cd/m2) 350 (Typ.) Touch Panel Projected capacitive touch panel Alarm Noise Sound pressure level over 60 dB(A) Communication Wi-Fi 802.11a/b/g/n Bluetooth Bluetooth v4.0 NFC Reading Distance Within 2 cm I/O Interface, Button & Indicators USB Port 1 x USB 3.0

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1 x USB 2.0

DC Power Output

DC Power Input Power Button Yes

Power LED Yes

Micro USB for 5V 2A with USB based define data transferring for USBBOX

1 x 15 V DC-in power jack

Specification DS-101 LED Light Bar

Battery Battery Type

Battery Contact Battery Capacity Battery Life Minimum operation time Battery Charge time from

depletion to 90% Power AC Adapter

DC-in Voltage & Current

By embedded controller Green: heart beat Red/Yellow/Blue: alarm

3S1P 103450 tap Wire

10.8 V, 2200 mAh 1 year 2 hour About 2 hour

60601 grade Input: AC 100 V–240 V / 50-60Hz, 0.98A

Output: DC 15 V, 2.4 A

Quick Charging Power Consumption

Regulation & Reliability Safety & EMC

Drop Survival Operating Temperature 0°C ~ 40°C (32°F ~ 95°F)

Storage Temperature -10°C ~ 60°C (14°F ~ 140°F) Transportation temperature -10°C ~ 60°C (14°F ~ 140°F) Operating Humidity 15% ~ 85% relative humidity Storage Humidity 10% ~ 95% relative humidity Transportation Humidity 10% ~ 95% relative humidity IP Protection IP 21 Expected Service Life 5 years

N/A, 0.3C

PCBA: 7 W (typical) LCD: 3 W (typical) USB Box: 5 W (typical)

IEC 60601-1, 60601-1-2, FCC Class B 96 cm with package

Others VESA Mount 75 mm x 75 mm Dimensions (WxHxD) 287.24 mm x 207.23 mm x 24.00 mm

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Specification DS-101

USB-BOX Specifications

Specification HS-101 IO Board Model USB-BOX-IOBD-R10 ECG Connector ECG connector snap latch fixed socket, 14-pin, green

SpO2 Connector NIBP Connector

Other Interface USB 2.0 Micro-B plug Defibrillator Protection

Operating Temperature Operating Humidity Operating Altitude Weight Protection Level

Snap latch fixed socket, 6-pin, blue Snap latch fixed socket, gray

Yes 0 ° C ~ 40°C (32°F ~ 95°F) 15% ~ 85% relative humidity Up to 3,000 m

157.5 g IP 21

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Dimensions

The physical dimensions of the DS-101 with stand are show bellow

DS-101 Dimensions (Unit : mm)

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The physical dimensions of the USB-BOX are show bellow.

USB-BOX Dimensions (Unit : mm)

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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. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:

l Reorient or relocate the receiving antenna. l Increase the separation between the equipment and receiver. l Connect the equipment into an outlet on a circuit different from that to which the

receiver is connected.

l Consult the dealer or an experienced radio/TV technician for help.

FCC Caution: Any changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate this equipment. This device and its antenna(s) must not be co-located or operating in conjunction with any other antenna or transmitter.

Safety

General Standard EN 60601-1: 1990+A1: 1993+A2: 1995

(Medical Electrical Equipment – Part 1: General Requirement for Safety)

EMC Standard EN 60601-1-2: 2007

(Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance Collateral standard:

Electromagnetic compatibility – Requirements and tests) Type of protection against electric shock Degree of protection against electric shock Operation Mode Continuous Operating Equipment The degree of protection against ingress of water Protection against Ignition of Flammable Gas

Class I Equipment (During AC power operation) Internally powered Equipment (During battery operation) ECG/RESP: Type CF Applied Part SpO2, NIBP: Type BF Applied Part'

IP 21

Not Provided

Performance

This section states the performance of this equipment.

Sound Pressure

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Alarm Maximum 83.0dB, Minimum 52.0dB HR Synchronized Tone Maximum 85.0dB, Minimum 32.0dB

ECG

Lead Type Wired 3, 10-electrode Frequency Characteristic 100Hz/40Hz/18Hz (3-electrode)

250Hz/150Hz/30Hz (10-electrode) Input Impedance 2.5Mohm and above Maximum Input Voltage ±5mV Polarization Voltage ±300mV Common Mode Rejection Ratio 90dB and above HR Measurement Range 0, 20 to 300bpm HR Measurement Accuracy ±1bpm HR Display Response Time Approx. 6 sec (12 Heartbeat average) Waveform Size Selection 1/4 (10-electrode only), 1/2, 1, 2, 4 (1 means 10mm/1mV) Seep Speed 25mm/sec Auxiliary Output Not Provided Defibrillation Proof Provided Heart rate meter accuracy and response to irregular rhythm

Response time of heart rate meter to change in heart rate

Time to ALARM for tachycardia Ventricular Tachycardia 1mVpp, 206bpm: Range 2 to 4 sec.,

Tall T-wave Rejection Capability 1.2mV T-wave can be removed when tested according to

Transient Characteristic 3.2 sec, 0.3 sec, 0.1 sec (time constant can be changed) Rejection of Pacemaker Pulse a) Pacemaker Pulse without Over/Undershoot'

80bpm Ventricular Bigeminy: 80bpm

60bpm Ventricular Bigeminy: 60bpm

120bpm Ventricular Bigeminy: 120bpm

90bpm Bidirectional Bigeminy: 90typ. (89-91) bpm

HR change from 80bpm to 120bpm: Range 7 to 9 sec., Average 8

sec

HR change from 80bpm to 40bpm: Range 8 to 10 sec., Average 9

sec

Average 3 sec

Ventricular Tachycardia 2mVpp, 206bpm: Range 2 to 4 sec.,

Average 3 sec

Ventricular Tachycardia 0.5mVpp, 206bpm: Range 2 to 4 sec.,

Average 3 sec

Ventricular Tachycardia 2mVpp, 195bpm: Range 2 to 4 sec.,

Average 3 sec

Ventricular Tachycardia 4mVpp, 195bpm: Range 2 to 4 sec.,

Average 3 sec

Ventricular Tachycardia 1mVpp, 195bpm: Range 2 to 4 sec.,

Average 3 sec

IEC60601-2-27.

Capable to reject pulses of pulse width 0.1 to 2ms, amplitude ±2mV

b) Pacemaker Pulse with Over/Undershoot

Rejection is not possible.

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Respiration

Method Impedance Method Frequency Characteristic 1.5Hz Current 100μA and below (at 64kHz ±5%) Measurement Range 0, 4 to 150bpm Measurement Accuracy ±3rpm Waveform Size Selection 1/5, 1/2, 1, 2, 4 (1 means 10mm/1Ω) Seep Speed 1.6mm/sec

SpO2 (Arterial Oxygen Saturation)

Measurement Method 2 Wavelength Pulse Wave Method

Wavelength: Approx. 660nm (red light), Approx. 940nm (Infrared Light)

Output: 15mW and below Measurement Range 40 to 100% Resolution 1% Measurement Accuracy Adult: ±3% when 70 to 100% PR Measurement Range 20 to 250bpm PR Accuracy ±3bpm Measurement Response Time 6 to 7 sec Measurement Value Update Time 1 sec Pulse Waveform Size Selection Automatic Pulse Waveform Seep Speed 25mm/sec

NIBP (Non-Invasive Blood Pressure)

Measurement Method Oscillometric Method Measurement Range 30 to 280mmHg/4 to 37.3kPa Resolution 1mmHg Static Pressure Accuracy ±3mmHg/0.4kPa BP Measurement Error according to the Clinical Performance Test Mean Error Within ±5mmHg Standard Deviation of Error 8mmHg or below Error of Cuff Pressure Display Within ±3mmHg PR Measurement Range 40 to 240bpm PR Accuracy ±2% or ±2bpm (whichever greater) Safety Mechanism 300mmHg or above

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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.

The following are examples of the common cause and countermeasures.

WARNING Static Electricity In a dry environment (room), static electricity is likely to occur. Take the following countermeasures. l Both operator and patient should remove any static electricity before entering the

room.

l Humidify the room.

WARNING Cellular Phone

l The radio wave may cause malfunction to the device. l Cellular phones and radio sets should be turned off in the room (building) where

medical device is located.

Caution Lightning A lightning nearby may induce excessive voltage to the equipment. If any danger is suspected;

l Use the uninterruptible power supply system. l Use the battery.

Caution High frequency noise interference from other device through the power outlet

l Check where the noise is originated and remove it using filtering device, etc. l Stop using the device that is originating the noise. l Use other power outlet.

EMC Guidance

Essential Performance

l Display function for ECG and SpO2 waveform and HR, SpO2 and NIBP numeric data l Alarm function l Accuracy of measured heart rate l Accuracy of measured SpO2 l Accuracy of Measured NIBP

Conformity Criteria

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<IEC60601-2-25> 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.

l When exposed to electrical fast transients and bursts, via the POWER SUPPLY CORD, the

ME EQUIPMENT shall continue to perform its intended function as described in the particular standard. Testing of PATIENT CABLES and interconnecting cables specified to be more than 3m in length may show temporary DEGRADATION during exposure to fast transients and bursts. 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 its intended function as described in the ACCOMPANYING DOCUMENTS. The ME EQUIPMENT shall comply with the requirements of 201.12.1.101.2 when the signal CAL20110 of Table GG.1 is applied.

<IEC60601-2-27> ECG / Heart Rate

l ME EQUIPMENT shall comply with subclasses 6.2.1.10 of IEC60601-1-2:2007 and the

accuracy of the detected heart rate shall be 60±6bpm.

l ME EQUIPMENT may show temporary DEGRADATION during ESD discharges. Within 10

l When exposed to electrical fast transients and bursts, via the POWER SUPPLY CORD, the

ME EQUIPMENT shall continue to display the heart rate. the accuracy of the detected heart rate shall be 60±6bpm. Testing of PATIENT CABLES and interconnecting cables specified to be more than 3m in length may show temporary degradation during exposure of fast transients and bursts. 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 display the heart rate. The accuracy of the detected heart rate shall be 60±6bpm.

l When exposed to a conducted radio frequency voltage, via the POWER SUPPLY CORD,

the ME EQUIPMENT shall continue to display the heart rate. the accuracy of the detected heart rate shall be 60± 6bpm. However, PATIENT CABLES are exempt from this requirement.

<IEC80601-2-30> NIBP

l ME EQUIPMENT shall comply with subclasses 6.2.1.10 of IEC60601-1-2:2007 and the

accuracy of the CUFF pressure shall be 180±2mmHg.

<IEC60601-2-49> Multifunction Monitor

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 as described in the ACCOMPANYNG DOCUMENTS.

l When exposed to electrical fast transients and bursts(EFT/B), via the POWER SUPPLY

CORD, the ME EQUIPMENT shall continue to perform its intended function as described in the DOCUMENTS. Testing of PATIENT CABLES, TRANCEDUCER cables and interconnecting cables specified to be more than 3m in length may show temporary DEGRADATION during exposure of fast transients and bursts. Within 10 s the ME EQUIPMENT shall resume normal operation in the previous operating mode, without loss of

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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.

<ISO80601-2-61> SpO2

l ME EQUIPMENT shall comply with subclasses 6.2.1.10 of IEC60601-1-2:2007 and shall

continue to provide basic safety and essential performance.

l No permanent degradation or unrecoverable loss of function, due to damage of ME

EQUIPMENT or software, or loss of data shall be observed at any IMMUNITY TEST LEVEL.

l Operation within the specified measurement accuracy limits (SpO2=90±5%, SpO2_PR=60

±3bpm) or generation of a technical alarm condition.

l In the event of disruption during IMMUNITY tests of IEC60601-1-2 6.2.2, 6.2.4, 6.2.5 and

6.2.7 may show temporary degradation. Within 30 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.

This equipment complies with EN 60601-1-2: 2007. However, if portable transmitter or wireless LAN equipment is used extremely nearby, the electromagnetic influence may largely exceed the compliance level and may cause unexpected phenomenon such as noise interference on the waveform, etc.

This equipment should be used in a location specified by each medical institution. If any unexpected noise interference on the waveform or failure to the peripheral device occurs,

stop using the equipment and follow the instruction of the technical engineer. The following is the information relating to EMC (Electromagnetic Compatibility). (When using this equipment, verify that it is used within the environment specified below.)

Compliance to the Electromagnetic Emissions

The DS-101 is intended for use in the electromagnetic environment specified below. The customer or the user of the DS-101 System should assure that it is used in such an environment.

Guidance and Manufacturer’s Declaration – Electromagnetic Emissions

Emission Test Compliance Electromagnetic Environment - Guidance

RF Emissions EN 55011

Group 1

The DS-101 uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment

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RF Emissions CISPR 11 Class B

Harmonic Emissions IEC 61000-3-2

Voltage Fluctuations/ Flicker Emissions

Class B

Class A

Complies

The DS-101 System is suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power supply network which supplies buildings used for domestic purposes.

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. This equipment complies with FCC radiation exposure limits set forth for an uncontrolled

environment. This equipment should be installed and operated with minimum distance 20cm between the radiator & your body.

This module is intended for OEM integrator only and limited to host with brand: Fukuda Denshi and model: DS-101. The OEM integrator is still responsible for the FCC compliance requirement of the end product, which integrates this module.

20cm minimum distance has to be able to be maintained between the antenna and the users for the host this module is integrated into. Under such configuration, the FCC radiation exposure limits set forth for an population/uncontrolled environment can be satisfied.

Any changes or modifications not expressly approved by the manufacturer could void the user's authority to operate this equipment.

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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.

Cause A scratch on the touch panel surface or foreign object entering the touch panel junction is causing misdetection of the key area. Solution The touch panel needs to be replaced. Contact our service representative.

ECG

<LEAD OFF> is displayed

Cause 1 The electrode is detached, or is not making good electrical contact with the skin. Solution Check the electrode attachment. Replace the electrodes. Check if the lead cable or relay cable is defective (wire break, etc.).

Cause 2 High voltage (abnormal voltage) is detected Solution Check the electrode attachment. Replace the electrodes. Check if the lead cable or relay cable is defective (wire break, etc.).

Cause 3 Low voltage (abnormal voltage) is detected Solution

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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. Solution Change the electrode site, or select a lead with higher QRS amplitude.

SpO2 Measurement

The pulse waveform is not displayed, or interrupted

Cause 1

The amplitude of the pulse waveform is too low, or the sensor is not positioned correctly. Solution Check that the light emitting and receiving parts of the sensor LED are aligned.

Cause 2 The sensor is defective. Solution Replace the sensor.

Cause 3 SpO2 sensor is not firmly connected to the connector. Solution Make sure the SpO2 sensor is firmly connected.

Cause 4 Sensor is exposed to light. Solution

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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. Solution Place a black or dark cloth over the sensor to avoid direct sunlight.

Non-Invasive Blood Pressure

The cuff is not inflated although the pump is operating.

Cause 1

The air hose is not firmly connected, and the air is leaking. Solution Check if the air hose is properly connected.

Cause 2 The cuff size does not match the selected patient type. Solution Use the cuff with correct size for the selected patient type.

 The pump is not operating.

Cause The air hose is disconnected from the NIBP Connector. Solution Check if the air hose is properly connected.

The measurement data is displayed as "---"

Cause 1

The measurement accuracy is not reliable due to body motion artifact. Solution During the measurement, have the patient stay still.

Cause 2 The pulse is too small to acquire reliable measurement accuracy. Solution

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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.

Temperature

No value display on the screen

Cause 1 Data is not transferring successfully

Solution Please contact with PC directly with close enough distance and place in the correct location

Cause 2 Thermometer value has been read once Solution Please measure and read the value again.

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Version History

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IEI Integration DS101WIFI Users Manual

Specifications and Main Features

Frequently Asked Questions

User Manual