Bionet Patient Monitor BM3 Pro User Manual
Bionet Patient Monitor BM3 Pro User Manual
User’s Manual
Patient Monitor
Rev. 4.00
Warning
To ensure proper use of this medical equipment, you must read and comply with this user manual.
Rev. 4.00 1
BM3 User Manual
SoftwareⓒBionet Co., Ltd.
All rights reserved.
Reproduction in any manner, in whole or in part, except for brief excerpts in reviews and scientific
papers, is prohibited without prior written permission of Bionet Co., Ltd.
Before using Bionet devices, read all the manuals that are provided with your device carefully.
Patient monitoring equipment, regardless of the complexity of the equipment, should never be
used as a substitute for the patient care, attention, and critical judgment that only trained health
care professionals can provide.
Rev. 4.00 2
Table of Contents
Intended Use ....................................................................................................................................................... 8
Functional safety............................................................................................................................................... 9
1. Basic ................................................................................................................................................................ 14
Overview ........................................................................................................................................................ 14
Biocompatibility ......................................................................................................................................... 16
Product Configuration............................................................................................................................ 16
Basic Unit....................................................................................................................................................... 18
Power ............................................................................................................................................................... 24
2. SETUP.............................................................................................................................................................. 33
Overview ........................................................................................................................................................ 33
Rev. 4.00 3
Monitor configuration............................................................................................................................ 33
Overview ........................................................................................................................................................ 40
4. Alarm .............................................................................................................................................................. 44
Overview ........................................................................................................................................................ 44
Alarm settings............................................................................................................................................. 47
5. TREND ............................................................................................................................................................ 49
Overview ........................................................................................................................................................ 49
Graphical trend........................................................................................................................................... 51
Tabular trend............................................................................................................................................... 52
6. ECG ................................................................................................................................................................... 57
Overview ........................................................................................................................................................ 57
Rev. 4.00 4
ECG signal processing and display.................................................................................................. 63
Display............................................................................................................................................................. 65
7. SpO2 ................................................................................................................................................................ 70
Overview ........................................................................................................................................................ 70
Precaution ..................................................................................................................................................... 70
Display............................................................................................................................................................. 73
SPO2Settings ............................................................................................................................................... 76
8. RESPIRATION.............................................................................................................................................. 78
Overview ........................................................................................................................................................ 78
RESP precaution......................................................................................................................................... 78
Display............................................................................................................................................................. 81
9. NIBP................................................................................................................................................................. 83
Overview ........................................................................................................................................................ 83
Display............................................................................................................................................................. 85
Rev. 4.00 5
10. EtCO2(*) ...................................................................................................................................................... 92
Overview ........................................................................................................................................................ 92
Precaution ..................................................................................................................................................... 97
Display........................................................................................................................................................... 100
Display........................................................................................................................................................... 109
Rev. 4.00 6
EtCO2malfunction ................................................................................................................................... 120
Rev. 4.00 7
Intended Use
The BM3 monitor is for multi-parameter patient monitoring. The instrument generates
visual and audible alarms when a variety of physiological parameters are monitored over
a pre-set limit and time, or where recording begins.
Note
All Bionet hardware and screenshots in this user guide are for illustration purposes only.
Actual products or screens may vary slightly.
General Description
Patient Classification
Rev. 4.00 8
BM3 monitors are designed for use on adults, pediatrics and neonates.
Functional safety
The essential performance of the patient monitor is to provide the clinician with
meaningful parameter values and to sound an alarm when the established parameter
value is exceeded or the function that provides the value is not working properly. We
assessed the risks associated with the use of these monitors in light of these essential
performance features and mitigated the risk of lowering the residual risk to a level that
could be used without compromise as long as the product maintained its regular
lifecycle maintenance and service recommendations.
Rev. 4.00 9
Warning, Caution, Note
The following terms are defined in the User Guide to emphasize the agreement as
follows:
The specifications and functions shown in this manual are subject to change without
prior notice.
Warning
Caution
Note
“Note” A note presents information that helps you operate the equipment or
connected devices.
Rev. 4.00 10
Defined groups
The defined groups for this product are users, service personnel, and experts.
Defined groups should read the user manual before using the product and be trained in
the use, installation, reprocessing, maintenance and repair of the product.
This product can only be used, installed, reprocessed, maintained and repaired by a
defined group.
User
Users use the product for their intended use.
Service personnel
Service personnel are responsible for the maintenance of the product.
They must be trained in the maintenance of the medical device, install, reprocess and
maintain the product.
Expert
The specialist repairs the product or performs complex maintenance tasks. The expert
has the knowledge and experience to perform complex maintenance tasks on your
product.
Rev. 4.00 11
General precaution on environment
Rev. 4.00 12
Electromagnetic Compatibility
The monitor has been designed and tested for compliance with current regulatory
standards as to its capacity to limit electromagnetic emissions (EMI), and also as to its
ability to block the effects of EMI from external sources.
The monitor complies with the following standards pertaining to EMI emissions and
susceptibility: EN60601-1-2.
Caution
Infectious devices and parts must be sanitized and cleaned before disposal.
사용안내서
Rev. 4.00 13
1. Basic
Overview
This patient monitor is for adult, pediatric, and neonatal monitoring. It can be used as an
independent device. Use of the monitor is limited to one patient at a time.
Caution
2. Be sure that the power source is the one supplied from Bionet. (DC18V,2.8A,BPM050
Made in Bridge Power Co., Ltd.)
3. Be sure that the entire connection cable of the system is properly and firmly fixed.
4. Be sure that the equipment is completely grounded. (If not, there might be problems
In the product.)
5. The equipment should not be placed in the vicinity of electric generator, X-ray,
broadcasting apparatus to eliminate the electric noise during operation. Otherwise, it
may cause incorrect result.
Caution
Rev. 4.00 14
The Equipment should be placed far from generators, X-ray equipment,
broadcasting equipment or transmitting wires, so as to prevent electrical noises
from being generated during the operation, When these devices are near the
Equipment, it can produce inaccurate measurements. For BM3both independent
circuit and stable grounding are essentially required. In the event that the same
power source is shared with other electronic equipment, it can also produce
inaccurate output.
Note
- Noise level is A class regarding IEC/EN 60601-1 and the subject of Nose is A level
concerning IEC/EN60601-1-2.
Warning
Do not touch the patient while using the defibrillator. The user may be at risk.
When using the defibrillator, be careful about safety and use only the supplied
cable.
Warning
In case the Equipment does not operate as usual or is damaged, do not use on
patient, and contact the medical equipment technician of the hospital or the
equipment supply division.
Rev. 4.00 15
Equipment connection
Caution
Doctors and patients in hospitals are exposed to the risk of uncontrollable currents.
This current is caused by a potential difference between the equipment and a
conductive object that can be contacted. Use auxiliary equipment to meet this
requirement in accordance with EN60601-1; 2011.
Biocompatibility
When used as intended, the parts of the product described in this operator manual,
including accessories that come in contact with the patient during the intended use,
fulfill the biocompatibility requirements of the applicable standards. If you have
questions about this matter, please contact Bionet or its representatives.
Product Configuration
3. Disposable electrodes 10 EA
9. Operator`s Manual 1 EA
Rev. 4.00 16
Optional Products
Warning
In order to avoid electrical shock, do not open the cover. Disassembling of the
equipment should be done only by the service personnel authorized by Bionet
Warning
Users must pay attention on connection any auxiliary device via LAN port or nurse
calling. Always consider about summation of leakage current, please check if the
auxiliary device is qualified by IEC 60601-1, or consult your hospital biomedical
engineer.
Rev. 4.00 17
Basic Unit
Front view
1
Rev. 4.00 18
Right side view
1 ECG connector
3 SpO2connector
4 Temperature connector
5 EtCO2 connector
Rev. 4.00 19
Left side view
1 Printer
Rev. 4.00 20
Back side view
1 2 3 4 5 6 7
1 Potential equivalent
4 DC input
6 Network connector
Rev. 4.00 21
7 HDMI output
Warning
USB Compatible
⚫ When using a product with high power consumption, such as an external hard
drive, be sure to use the provided adapter for suitable power supply. (Cannot be
used alone as a power supply)
⚫ You should save the data of connected device before connecting the additional
device.
Rev. 4.00 22
Device Markings
Caution :
documents
Temperature NIBP
Rev. 4.00 23
IP (Ingress Protection)
Power
The BM3 monitor uses a DC adapter (100-240 VAC / 18VDC 2.8A). In the event of a
power outage or cable shortage, the monitor automatically switches to battery power to
continue patient monitoring without data loss. The built-in battery is intended for back-
up use only during power-off.
DC Product information
Manufacture: BRIDGEPOWER CORP.
DC Power LED is lighted on when the DC Power is plugged into the inlet at the back of
the product. A press of power key makes the machine ready for use.
Caution
Using non-standard products other than the adapters supplied by us may cause
signal distortion or noise. Be sure to use a genuine adapter that is supplied by our
company and is insulated.
Battery power
DC adapter, it uses battery power when power failure and portable use.
The battery is attached to the bottom of the equipment and the additional extended
battery is connected to the left side.
Rev. 4.00 24
- Battery: 3BL335-BIO-S (10.8V / 3250mAh, Li-ion) or
Operation
3. The charging status of the batteries is displayed with 5 green boxes, each indicating a
different charging. (5% -> 25% -> 50% ->75% -> 100%)
The monitor automatically turns off when the battery is depleted. The table below
describes the function of the battery charging bar graph at the top of the screen.
Rev. 4.00 25
Immediately connect the monitor to
Your battery is charged at 25%
the AC adapter.
Caution
The battery charge display is displayed correctly only when the battery is operating
normally
Note
Warning
note
⚫ To maximize the charge for transport, keep the monitor connected until
you are ready to transport the patient. Reconnect the monitor immediately
after transport.
⚫ Bionet recommends replacing the lithium ion battery after 24 months of
use.
⚫ Battery life depends on usage. If battery life continues, battery life will
decrease and frequency of replacement will increase.
⚫ To prevent pre-discharge, recharge after the battery is discharged.
Rev. 4.00 26
Caution
The battery charge display is accurate only when the battery is operating normally.
-Continuous Battery Usage Time: 2 hours or more when fully charged (measured every
15 minutes Nibp with SpO2 and ECG)
Warning
5. Presence of battery: When the battery is disconnected from the equipment and it
malfunctions, it shows 'X' as shown below.
Note
When replacing the battery, be sure to remove the DC adapter and replace it.
Rev. 4.00 27
How to replace the battery
The following are the key points you should know about Lithium-Ion battery technology:
The battery will discharge on its own, even when it is not installed in a monitor. This
discharge is the result of the Lithium-Ion cells and the bias current required for the
integrated electronics.
The self-discharge rate doubles for every 10°C (18°F) rise in temperature.
As the battery ages, the full-charge capacity of the battery will degrade and be
permanently lost. As a result, the amount of charge that is stored and available for use is
reduced.
Rev. 4.00 28
Warning
When replacing the battery, only use the battery provided by Bionet. Check the battery is
properly secured to the bracket. Do not cause a serious impact on the battery.
Ignoring the above warnings will cause battery explosion and serious damage to devices.
Conditioning Guideline
The battery in the monitor full charged and discharged every six months and condition it using
the battery charger.
Storage Guideline
Store the battery outside of the monitor at a temperature between 20°Cto 25°C (68°F to 77°F).
When the battery is stored inside a monitor that is powered by an AC power source, the battery
cell temperature increases by 15°C to 20°C(59°F to 68°F) above the room’s ambient temperature.
This reduces the life of the battery.
When the battery is stored inside a monitor that is continuously powered by an AC power source
and is not powered by battery on a regular basis, the life of the battery may be less than 12
months. Bionet recommends that you remove the battery and store it near the monitor until it is
needed for transport.
When the battery no longer holds a charge, it should be replaced. The battery is recyclable.
Remove the old battery from the monitor and follow your local recycling guidelines.
Warning
EXPLOSION HAZARD —
DO NOT incinerate the battery or store at high temperatures. Serious injury or death could
result.
Rev. 4.00 29
Getting Started
Press the power key (O) at the bottom right of the monitor front panel. The power light
on the monitor lights up, the alarm bar lights up, the power is turned on, the screen
lights up, the main screen is displayed after running the self-test.
Press and hold the power key (O) for 3 seconds. The screen goes off.
3
1
Rev. 4.00 30
The parameter box displays values, alarm limits and icons for the selected parameter.
You can set the parameters and their associated waveforms so that they are easy to
distinguish.
The message appears at the top of the screen. The patient name is displayed in the
upper left corner of the screen. The top right of the screen displays the time and device
management status.
The rotary knob switch allows the user to navigate menus, select settings,
and perform menu functions. Rotate the rotary knob to move the menu item.
To confirm the selection, press the rotary knob switch.
Fixed key
The fixed keys on the front panel of the monitor allow you to perform commonly
performed functions.
Rev. 4.00 31
Function key
On the right side of the monitor's front panel, the touch screen icon on the touch screen
allows you to perform frequently-used functions.
Rev. 4.00 32
2. SETUP
Overview
This chapter describes how to configure your monitor and how to upgrade your software.
Monitor configuration
Rev. 4.00 33
Main menu setup
The Setup menu allows the user to access submenus, display screens, and perform specific
monitor setup functions.
1. To display the Settings menu, click the Settings icon to open the submenu.
2. Click the desired setting to access the submenu that performs the desired function or
goes one step further down.
3. Click Close at the bottom of the submenu list to return to the previous menu or screen.
F. SW LICENSE
Rev. 4.00 34
A. SETUP menu
Rev. 4.00 35
A-3-2.KEY Sound Set Key activation ON / OFF
A-3-3.KEY Volume Set Key sound OFF ~ 100%
A-3-4.AC FILTER Power filter settings OFF, 50Hz, 60Hz
A-3-5.SCREEN BRIGHTNESS Set screen brightness 10~100%
A-3-6.DATE DISPLAY Set type of date display ON / OFF
A-3-7.DEMO Set Demo ON / OFF
A-4.SYSTEM INFORMATION
A-4-1.MAIN VERSION Display main S/W version
A-4-2.NIBP VERSION Display NIBP Module version
Set language English, Korean
French, Bulgarian
Polish, German
Chinese, Portuguese
Hungarian, Czech
A-4-3.LANGUAGE
Romanian, Italian
Turkish, Spanish
Russian, Greek
Japanese
BIONET
12.5 mm/sec
Rev. 4.00 36
(ECG/SPO2/RESP) 25 mm/sec (default)
50 mm/sec
B-2.NIBP
B-2-1. ZERO Calibration NIBP Zero calibration menu Zero calibration menu at
atmospheric pressure
D.MAKER SERVICES
Rev. 4.00 37
D-1. MAC ADDRESS Editing Enter a unique address
for the device
D-2. Factory Reset Reset menu for setting the device to Perform factory reset
factory default state
Rev. 4.00 38
Parameter color
Selectable colors
Green, light blue, yellow, purple, blue, sky blue, orange, gray, light green, pink, white, red, light
yellow
SpO2 Blue
RESP Yellow
NIBP Purple
TEMP Green
ETCO2 Yellow
Rev. 4.00 39
3. Admission and Discharge
Overview
The Patient admission menu allows you to enter and edit a patient’s personal data (name,
ID, Birthday, Height, Weight). If your monitor is operating in a network monitoring, you
can also review or change the monitor’s care unit and bed label assignments.
Patient data and trends can also be transferred to PC. The transfer procedure depends
on whether the Inbound and Outbound monitors are connected to the Central network.
Patient admission
Note:
⚫ To change a patient's classification (adult, pediatric or neonate), access the
patient settings menu.
⚫ Additional settings (Gestational Age) are available for neonate mode.
Rev. 4.00 40
Patient discharge
The patient should be discharged before the other patient is admitted. Otherwise
The monitor attaches the existing data to the patient already admitted.
Admit Admit
ADULT
PEDIATRIC
NEONATE
Rev. 4.00 41
Main menu Sub menu
A. Admit / Discharge
Rev. 4.00 42
Registration of patient ID using barcode
This product can input the PATIENT ID in barcode format to the device using USB barcode
scanner. First, connect the barcode scanner to the USB HOST connector on the left as shown in
the figure below. After the BEEP sound is generated, the barcode icon ( ) appears at the
bottom of the instrument screen.
The barcode that you want to input is matched to the index LED generated by the scanner, and if
you press the input button, the corresponding ID is read and sent to the equipment. The sender
ID is displayed at the top center of the screen.
Rev. 4.00 43
4. Alarm
Overview
The monitor displays the alarm limits (parameter threshold) and can be configured by the user to
raise an alarm if exceeded. Limits are displayed both in the alarm limits table and in the
parameter box. If this limit is exceeded, a visual or audible alarm will occur.
The bedside monitor is the primary alarm device, and there may be other secondary alarm
devices depending on how you configured the device / network. Depending on the alarm
condition, the monitor generates an alarm using one or more of the following devices:
Alarm priority
The alarm type is divided into a patient status alarm and a product status alarm.
The patient status alarm sounds when the diagnostic function (ECG 3 auto diagnosis) and alarm
upper and lower limits are exceeded, and there are levels of HIGH, MEDIUM, LOW and MESSAGE,
and there is a difference in the order and volume of the alarm.
You can set the alarm level for each parameter and function.
The patient status alarm provides the highest priority alarm.
The features of each alarm are described as follows. The alarm priority is HIGH> MEDIUM> LOW>
MESSAGE. For alarms over MEDIUM, the printer output is supported when ARMRM PRINT ON is
set.
Rev. 4.00 44
Alarm priority Alarm sound Alarm Color Alarm printer Handle Alarm
Lamp
HIGH
Every 2 seconds
-2 Non Blinking
Blinking
MESSAGE
Non Blinking
: Alarm sounds
Audible alarm
Rev. 4.00 45
LOW 1 low tone every 30 seconds 2 consecutive beeps every 30 seconds
Alarm management
You can use the lock key on the front of the monitor to hold the alarm.
To change Alarm Mode: A short press of the alarm control key circulates through the Normal /
Audio_Paused / Alarm_Paused alarm modes. Press and hold the key for more than 3 seconds to
switch to Alarm_Off / Audio_Off mode using the mode selection dialog regardless of which alarm
mode the monitor is currently in
Audio_Paused: Stop the audible alarm for 1 minute but the visual alarm is activated still. Banner
with the message Audio Paused and countdown timer are displayed on the screen. After the user
switches to another alarm mode or after the timeout period has elapsed if the alarm occurs
still,visual and audible alarms will be activated again
Alarm_Paused: Stop visual and audible alarms during user defined time. Banner with the message
Alarm Paused and countdown timer are displayed on the screen. After the user switches to
another alarm mode or after the timeout period has elapsed if the alarm occurs still, visual and
audible alarms will be activated again
Alarm_Off: Stop visual and audible alarms. A banner with the message Alarm Off is displayed on
the screen. The monitor maintains Alarm Off mode until user switch to another alarm mode.
Audio_Off: Stop the audible alarm. A banner with the message Audio Off is displayed on the
screen. The monitor maintains Audio Off mode until user switch to another alarm mode
Alarm control:
Various alarm functions, such as alarm hold, validity and alarm limit indicators, can only be
configured in the alarm control menu, accessible only through the password protected unit
manager menu.
Nurse call:
If the monitor is sounding an alarm, the nurse call system is signaling.
When an audible alarm is silenced (Audio Paused or Audio Off) at the bedside unit, the nurse call
system will not alarm.
Your system administrator can change the alarm priority level for the nurse call signal.
Rev. 4.00 46
if the priority level is set to High, only high-priority alarms will sound on the nurse call system.
Note
⚫ Audio Paused and Audio Off modes only stop the audible alarm sound and touch or key
sound is activated always.
⚫ To adjust the Touch or Key Sound, use the Key Sound menu in Setup.
Alarm settings
A-3.Alarm Parameter
A-4.Nurse Call
B. Alarm Review
Setup menu
A-3-1.Alarm Volume The volume can be changed from OFF 10~ 100%
to 10% to 100%.
Rev. 4.00 47
A-3-2. Alarm Pause Time No sound for 5minutes, Release on 1,2,3,5,10,15min
alarm again
One time
Cycling
Message/ Low/
A-4-4.Level
Medium/High
Alarm Review
Rev. 4.00 48
5. TREND
Overview
The monitor stores trend data for all connected signals. Users can request trend recording and
can also print the screen of trends displayed.
Triggered alarm events are displayed in red inverted triangles on the Event List and
Timeline
Trend setup
D. Trend Export
Rev. 4.00 49
MENU Description Available settings
A-1.Popup Trend
A-1-1.Time Period Show time interval setting menu 30min, 60min, 90min,
3hour, 6hour
A-1-2.Configure Parameters
D-1. Start Time Parameter save start time setting menu hh:mm
Rev. 4.00 50
D-2. End Time Parameter Save Last Time Setting Menu hh:mm
D-3. Export Time Period Time period setting 1min, 5min, 10min,
Ascending
D-5. Export
Graphical trend
Trend graph shows saved trend data as individual graph type for each parameter. These graphs
show that the displayed parameters are active over a significant period of time Shows five
channels at a time. Confirmation color and scale Meter labels and numbers are displayed on the
left side of the trend channel. Vertical lines in each graph. This displays the time distribution.
Trends keeps the most up-to-date data. It is automatically updated on the right side of the graph.
1 2 3 4
8 9 10 11
Rev. 4.00 51
① Graphic trend select menu
⑤ Patient ID
⑩ Printer menu
Tabular trend
The Trends table displays the trend data in an easy-to-read table format. Up to six are displayed,
updated every minute. The time stamp above each column indicates the interval at which the
data in that column was trended. The value displayed is the last one acquired during the interval,
and the most recent data is displayed in the rightmost column.
Rev. 4.00 52
1 2 3 4
8 9 10 11
⑤ Patient ID
⑩ Printer menu
Rev. 4.00 53
⑪ Parameter select window menu
File export
The file extract function can transfer trend to a file using USB memory.
③ Set a start time, end time, export time period, and export order.
⑤ The data is transferred to USB memory. A completion message is displayed when the
transmission is completed.
Warning
USB Compatible
⚫ When using a product with high power consumption, such as an external hard drive, be
sure to use the provided adapter for suitable power supply. (Cannot be used alone as a
Rev. 4.00 54
power supply)
⚫ You should save the data of connected device before connecting the additional device.
Note
Popup trend
The user can continue to monitor the main screen waveform and parameter box while displaying
trend data for up to 5 parameters for up to 6 hours. The pop-up trend graph follows the display
order indicated by each parameter in the trend setup and is updated with new trend data every
60seconds. When selecting pop-up trend.
Rev. 4.00 55
You can change the size of the popup menu by pressing and releasing the center of the popup
menu for at least 1second.
Rev. 4.00 56
6. ECG
Overview
The monitor can calculate heart rate and display ECG data. The electrocardiogram screen provides
1 channel display. It calculates the heart rate by detecting the electrocardiogram signal of the
patient and alarms according to the set upper and lower limit of alarm.
SpO2
T
ECG
CO2 Connector
Electrode placement
1. If you have a lot of hair, shave. With alcohol-soaked cotton, wipe the patient's skin to
attach the electrode. Avoid wrinkled or uneven skin, and wipe off alcohol with a dry
cotton towel.
3. Remove the rear mounting surface of the electrode. Be careful not to touch the adhesive
side.
Rev. 4.00 57
5. Connect the lead of the electrode and the wire of the monitor
6. Fix the electrode to the skin, and secure the cable with the remaining length between the
instrument and the electrode with surgical tape. This fixation prevents the electrode from
moving.
Note
⚫ Make sure that the contact area of the disposable electrode is not dry to maintain a
good connection between the electrode and the skin.
⚫ If you suspect that the disposable electrode is in poor contact, replace it immediately
with a new electrode. Otherwise, the contact impedance of the skin and electrode will
increase, and the correct ECG signal will not be obtained.
⚫ If the contact condition gets worse before expiration date on the packaging, replace
with a new one.
⚫ To get a stable ECG waveform, rub the skin with gel or benzoin tincture.
ECG Precaution
Caution
⚫ Use caution when using evoked potential equipment as it may interfere with ECG
monitoring.
Warning
CABLES — Route all cables away from patient's throat to avoid possible strangulation.
Rev. 4.00 58
of the neutral electrode and ground.
DEFIBRILLATION — Do not come into contact with patients during defibrillation. Otherwise
serious injury or death could result.
To avoid the risk of serious electrical burn, shock, or other injury during defibrillation, all
persons must keep clear of the bed and must not touch the patient or any equipment
connected to the patient.
After defibrillation, the screen display recovers within 10seconds if the correct electrodes are
used and applied in accordance with the manufacturer’s instructions.
Patient cables can be damaged when connected to a patient during defibrillation. Check
cables for functionality before using them again.
The peak of the synchronized defibrillator discharge should be delivered within 60ms of the
peak of the R wave. The signal at the ECG output on the patient monitors is delayed by a
maximum of 30ms.
If the ECG waveform on the screen is too unstable to synchronize with the patient’s heart
beat because of the following reason, remove the cause of an alarm, message, or unstable
ECG, and then use a stable ECG lead for synchronization.
INTERFACING OTHER EQUIPMENT — Devices may only be interconnected with each other
or to parts of the system when it has been determined by qualified biomedical engineering
personnel that there is no danger to the patient, the operator, or the environment as a
result. In those instances where there is any element of doubt concerning the safety of
connected devices, the user must contact the manufacturers concerned (or other informed
experts) for proper use. In all cases, safe and proper operation should be verified with the
applicable
Manufacturer’s instructions for use and system standards IEC 60601-1-1/EN 60601-1-1 must
be complied with.
Rev. 4.00 59
Electrosurgery Unit
✓ Electrosurgical units (ESU) emit a lot of RF interference. If the monitor is used with an
ESU, RF interference may affect the monitor operation.
✓ Locate the monitor as far as possible from the ESU. Locate them on opposite sides of
the operating table, if possible.
✓ Connect the monitor and ESU to different AC outlets located as far as possible from
each other.
✓ When using this monitor with an electrosurgical unit, its return plate and the electrodes
for monitoring must be firmly attached to the patient. If the return plate is not attached
correctly, it may burn the patient’s skin where the electrodes are attached.
During surgery:
Use the appropriate orange electrode ECG safety cable, or lead cable with a red connector,
for measuring ECG in the operating room. These cables have extra circuitry to protect the
patient from burns during cautery, and they decrease electrical interference. This also
reduces the hazard of burns in case of a defective neutral electrode at the HF device. These
cables cannot be used for measuring respiration.
Rev. 4.00 60
Patient preparation
Careful skin preparation and proper electrode placement allow you to receive a strong signal that
minimizes handwriting. If a technical alarm (e.g. lead disconnect) has occurred, prepare the patient
again according to the following recommendations.
Follow hospital approved clinical procedures to prepare the patient's skin. Change the electrode
every 24 to 48 hours to improve signal quality. You may need to replace the electrode more often
in the following situations:
There are a variety of reusable and disposable electrodes available. Choose the electrode that
best fits your monitoring situation. Bionet recommends Ag / AgCl disposable electrodes.
If you are using an electrode with a gel beforehand, make sure that the electrode is sufficiently
gelled. Never use this product if the disposable electrode has expired or the gel is dry.
Determine the electrode location that will provide the best ECG in the configuration (P-wave and
T-wave amplitudes should not exceed 1/3 of the QRS amplitude). Choose a flat, muscular location
to maximize contact with the electrodes and minimize muscle fatigue. Avoid joints or bony
protrusions. When choosing a location for electrode placement, consider the following special
conditions: Surgery - Place electrodes as far away from the surgical site as possible. Burn patient -
use sterile electrodes. Thoroughly clean the equipment. Follow hospital infection control
procedures.
Use a waterproof tape (about 2 inches wide) or Steri-Drape to secure the electrode Protect from
liquids. Make a small loop from the lead wire just below the connection and secure with tape.
Rev. 4.00 61
ECG lead
Rev. 4.00 62
Cable color and size
3LEAD / 5LEAD
The monitor is a QRS Complex with a QRS complex amplitude of 0.4 to 5.0 mV (0.2-5.0 mV with a
scale setting of 0.5 mV / cm or less) and an adult with a QRS width of 70-120ms (or a newborn
with a QRS / ARR Select chapter). The heart rate is calculated from 15 to 300 times per minute
using the last 10seconds of the R-R interval and the two longest intervals and the two shortest
intervals at the R-R interval. The remaining interval is averaged, and the current heart rate is
displayed in the HR parameter box of the main screen as a result.
Rev. 4.00 63
When the ECG signal is 80 BPM, the interval of the T wave is 180ms, and the QT period is 350ms.
High P-wave and T-wave - Long P-wave or T-wave with high amplitude duration can be detected
by QRS Complex. Place the leads on the ECG1 channel with the highest R-wave (compare to T-
wave and / or P-wave) to allow the monitor to properly detect low heart rate conditions in this
situation. If the monitor continues to misinterpret the P-wave or T-wave, use a pulse oximeter to
reposition the electrodes or monitor the patient's pulse rate.
Rev. 4.00 64
Display
① ③
ECG Settings
A-3.Display Option
A-4.Pace Maker
A. ECG menu
Rev. 4.00 65
A-1-2.TECHNICAL ALARM ECG-LEADFAULT
CONDITION ECG-CHECKELECTRODE
ECG-HR-SEARCH
A-2.QRS VOLUME QRS detection volume setting menu. OFF, 0%~100%
A-3.DISPLAY OPTION
A-3-1.SWEEP SPEED The speed of the ECG displayed on the 6.25mm/s, 12.5mm/s,
screen can be set. Default setting:
25mm/s, 50mm/s
25mm/s
The ECG channel is selectable from I to I, II, III, aVR, aVL, aVF,
V6. V
Rev. 4.00 66
aVF, V can be selected.
Rev. 4.00 67
Trouble shooting
Problem:
Solution:
3. Scroll through all ECG leads and check for 0.5mV amplitude at normal (1X) size.(at
least0.5mV amplitude is required for QRS detection.) For borderline signals, validate on a
graph.
Problem:
Solution:
Check ECG signal from patient: (the chest lead may exhibit polarity changes which may
occasionally cause an inaccurate call.)
Rev. 4.00 68
3. Check the condition of the electrode and replace it if necessary. (if chest lead is a problem,
move the chest electrode to another chest position or leg position.)
Problem:
Solution:
2. Display the lead of ECG with the greatest amplitude in the top waveform position.
Rev. 4.00 69
7. SpO2
Overview
SpO2 monitoring is a non-invasive technique that measures the total amount of oxygen in
hemoglobin. The pulse rate is measured by measuring the absorption of the wavelength of the
selected light. The light emitted by the sensor in the probe passes through the tissue and is
converted into an electrical signal by the light-detecting sensor in the probe. The monitor
processes the electrical signal and displays the waveform, %SpO2, and pulse rate on the screen as
quantified values. Red and infrared rays are passed through the capillaries of the fingertip to
detect the pulsating component, calculate HR and oxygen saturation, and alarm according to the
set alarm value.
Precaution
SpO2 measurements are particularly sensitive to arterial and arteriolar pulse rates. Patients
experiencing shock, hypothermia, anemia, or patients taking medications that reduce arterial
blood flow may have incorrect measurements.
Warning:
⚫ The pulse oximeter cannot be used as an apnea monitor.
⚫ High oxygen levels can make premature babies vulnerable to retrolental fibroplasia.
When this is the case, do not set the maximum alarm limit to 100%, such as the effect of
turning off the alarm. Percutaneous pO2 monitoring is recommended for premature
infants receiving supplemental oxygen.
⚫ Inspect the applied area every 2-3 hours to check the skin condition and check if it is
attached to the naked eye. If skin conditions change, move the sensor to another
location. Change the application site every 4 hours at least.
⚫ Use only Bionet-designated sensors. Other sensors may not provide adequate protection
against defibrillation or may put the patient at risk.
⚫ Disposable accessories (disposable electrodes, transducers, etc.) should be used only
once. Do not reuse disposable accessories.
Rev. 4.00 70
Patient preparation
The accuracy of SpO2 monitoring is largely dependent on the strength and quality of the SpO2
signal.
If you use your fingers as a monitoring site, remove the nail polish. Cut the patient's fingernail if
needed to improve placement of the sensor. Only use sensors provided by Bionet and apply them
according to manufacturer's recommendations on a per-sensor basis.
If the sensor is not attached correctly, the ambient light may interfere with the pulse oximetry,
making the measurement irregular or causing the value to disappear. If you suspect interference
from ambient light, make sure that the sensor is properly positioned and that the sensor cover
with the opaque body is covered.
1. Select the sensor type and size that best suits your patient.
2. If the sensor can be reused, please wash it before use for each patient.
3. Position the sensor correctly and attach it to the patient.
4. Connect the sensor to the patient cable.
5. Check the application area of the sensor from time to time. If the sensor is too tight, it may
delay blood flow or overheat the skin and damage the tissue. Do not use a damaged sensor.
Note: Read the documentation that came with your sensor for the best application technology
and safety information. Never use a damaged sensor.
Note: If the sensor does not turn on after connecting the sensor, observe that a message appears
on the monitor. If the sensor-LED does not turn on, replace the sensor.
Rev. 4.00 71
SpO2connector
SpO2
SpO2
T
SpO2
CO2 Connector
SpO2 measurementCable
Note
The insulated input ensures patient safety and protects the device during defibrillation and
electrosurgery.
Rev. 4.00 72
Display
①
②
③ 150
60
④ ⑥
The current SPO2 value and the derived pulse rate (RATE) are displayed. The block sets indicate
the strength of the signal (twenty block bars indicate the strongest signal). The SPO2
measurements are averaged over a 6-second period of time.
The SPO2 monitoring features are found in the SPO2 menu. These features include alarm limit
adjustment, display of RATE, and RATE volume.
Rev. 4.00 73
Note
It is extremely important to determine that the probe is attached to the patient correctly and the
data is verifiable. To make this determination, three indications from the monitor are of
assistance—signal strength bar, quality of the SPO2 waveform, and the stability of the SPO2values.
It is critical to observe all three indications simultaneously when ascertaining signal and data
validity.
The signal strength bar is displayed within the SPO2 values window. This bar consists of 10 blocks
set depending on the strength of the signal. Proper environmental conditions and probe
attachment will help to ensure a strong signal.
Under normal conditions, the SPO2 waveform corresponds to (but is not proportional to) the
arterial pressure waveform. The typical SPO2 waveform indicates not only a good waveform, but
helps the user find a probe placement with the least noise spikes present. The figure below
represents an SPO2 waveform of good quality.
Rev. 4.00 74
If noise (artifact) is seen on the waveform because of poor probe placement, the photodetector
may not be flush with the tissue. Check that the probe is secured and the tissue sample is not too
thick. Pulse rate is determined from the SPO2 waveform which can be disrupted by a cough or
other hemodynamic pressure disturbances. Motion at the probe site is indicated by noise spikes
in the normal waveform. (See the figurebelow.) It has been noted that letting the patient view the
SPO2 waveform enables them to assist in reducing motion artifact.
Stability of SPO2Values
The stability of the displayed SPO2 values can also be used as an indication of signal validity.
Although stability is a relative term, with a small amount of practice one can get a good feeling
for changes that areartifactual or physiological and the speed of each. Messages are provided in
the SPO2 values window to aid you in successful SPO2 monitoring.
WARNING
In the monitoring of patients the coincidence of adverse conditions may lead to a disturbed
signal going unnoticed. In this situation artifacts are capable of simulating a plausible
parameter reading, so that the monitor fails to sound an alarm. In order to ensure reliable
patient monitoring, the proper application of the probe and the signal quality must be
checked at regular intervals.
Rev. 4.00 75
SPO2Settings
A. SPO2menu
SPO2-POORSIGNAL
SPO2-LOSTPULSE
SPO2-ARTIFACT
SPO2-PULSE SEARCH
A-3-1.SWEEP SPEED It can set the speed of SPO2 displayed 6.25mm/s, 12.5mm/s,
on the screen. Default: 25 mm/s.
25mm/s, 50mm/s
Status messages
Below is a list of system status alarm messages which may be displayed in the SPO2 parameter
window during monitoring.
CHECK PROBE
Reusable finger probe is off the patient. Check the probe. The factory default for this alarm is
Rev. 4.00 76
MESSAGE ALARM.
PULSE SEARCH
Detection by the monitor of a repeatable pulse has ceased. Check the patient and the probe site.
POOR SIGNAL
The SPO2 signal is too low. No SPO2 data is displayed. This can be due to a low patient pulse,
patient motion, or some other interference. Check the patient and the probe.
LOST SIGNAL
SPO2 data continues to be displayed, but the quality of the signal is questionable. Check the
patient and the probe.
ARTIFACT
It indicates that something happened to the pulses; determine if the artifact to be abnormal and
irregular
Rev. 4.00 77
8. RESPIRATION
Overview
Respiration via ECG Lead I or Lead II electrode makes the skin area of the chest enlarged, causing
changes in the resistance of skin. Through this it calculates respiration value per minute and
performs the alarm function according to limit value.
The monitor can use ECG leads I or II for breath detection, regardless of the leads selected for
QRS processing. The measurement range for impedance breath monitoring is 0 to 155 breaths
per minute. The alarm setting range is 5 ~ 150 breaths per minute. You can monitor the heart
rate, SpO2 using the appropriate accessories, and display the relevant values in the Oxy cardio
respirogram.
RESP precaution
⚫ Impedance breath monitoring should not be considered the only way to detect breathing
stops. Bionet recommends monitoring of additional parameters, such as EtCO2 and SpO2
that indicate the patient's oxygen supply status.
⚫ • If you use an ESU block or cable, the impedance breath monitor may not work and the
pacemaker detection performance may be degraded. If pacemaker detection is enabled,
ESU interference may be detected as a pacemaker.
⚫ • Large amplitude pacemaker pulses (>100mV) may interfere with the monitor's breath
measurement or detection function.
Rev. 4.00 78
Patient Preparation
Skin preparation and electrode placement must be properly and carefully monitored in impedance
breath monitoring. You can produce reliable results. Follow the same recommendations as ECG
monitoring Please. In general, the electrodes should be placed as clean as possible with the 60Hz
noise minimized to make it possible to generate a signal. The best results can be obtained when
the electrode is firmly bonded and the electrode area is wide. To improve the RESP signal, use a
5-lead cable set (RL as a neutral electrode). It is recommended that the electrode be placed in the
maximum expansion and contraction range of the lung, especially if deep breathing is involved.
For newborns, place the RA and LA electrodes on the mid-armpit line with the nipple. Place the
LL electrodes under the diaphragm and navel. Avoid the liver and the ventricles of the heart to
prevent 60Hz noise from pulsatile blood circulation. The following figure shows where we
recommend placing ECG leads for impedance breathing in adults and neonates
Lead I
Respiration
position
LeadII
Respiration
position
Rev. 4.00 79
Respiration connector and measurement cable
Respiration connector
SpO2
T
ECG
CO2 Connector
Respiration
cable
Note
Respiration Rate measures the cable and connector will be used as the ECG and common.
Rev. 4.00 80
Display
RESP Settings
A. RESP menu
RESP-CHECK ELETRODE
for respiration
25mm/s,
Rev. 4.00 81
A-2-2.SIZE A menu to setup Wave Display 2, 4, 6, 8, 10
Respiration waveform
Rev. 4.00 82
9. NIBP
Overview
The monitor can acquire and process non-invasive blood pressure (NIBP) signals and display the
output. Blood pressure measurements are determined by the oscillometric method and are
equivalent to those obtained by intra-arterial methods, within the limits prescribed by the
Association for Advancement of Medical Instrumentation, Electronic Automated
Sphygmomanometers (AAMI/ANSI SP-10).
If the pulse signal is poor due to patient movements, improper cuff placement or noise in the
signal, the cuff deflates and the monitor attempts a second measurement. For causes and possible
remedies for a poor pulse signal see the alarm message tables. The hose connects the cuff to the
monitor to determine the contraction, expansion and mean blood pressure of an adult, pediatric
or neonatal patient. The monitor can start the blood pressure measurement alone with set
intervals, or persistence lasting more than 5minutes.
NIBP Connector
SpO2
T
NIBP
CO2 Connector
Rev. 4.00 83
Adult Cuff
Rev. 4.00 84
NIBP Disposable Cuff Neonate 2 (4.2~7.1cm) Option
Note
The NIBP should be set in the menu because the measured value differs depending on the
patient's age and gender.
Display
① ② ③ ④ ⑤
⑦ ⑧ ⑨ ⑩
Rev. 4.00 85
④ Measure time: Indicates the schedule counter time of measuring.
⑦ Interval Time: indicates interval time when measures the blood pressure
periodically.
⑩ Mean blood pressure: Indicates the maximum limit of mean blood pressure.
NIBP Settings
A. NIBP menu
Rev. 4.00 86
A-3.INFLATION It is a function to set the range that is ADT :
usually used by setting pressure at the
120 – 250 mmHg
beginning because it can give pain to
the patient when the equipment is PED :
Rev. 4.00 87
C-1.VITAL SIGN REVIEW Record the 40 most recently measured
blood pressure values.
Warning
Check periodically to see if the circulation from the cuff to the distal part of the patient's
arm is good.
1minute and 2minute intervals When using automatic measurement, check the patient's
condition frequently. It is not recommended for measuring blood pressure for a long time if
the measurement time period is set to 10minutes or less.
Note
Safety Considerations
Software and Hardware for Cuff pressure Blocking:
The cuff is automatically reduced when the measurement time is longer than two minutes in
Adult / Pediatric mode and more than 90seconds in Neonatal mode. Extension limits are set
for all patient categories to prevent overpressure on the patient.
Check the following list to the ensure monitor operates properly and safely at all times.
2. Check for residual air left in the cuff from a previous measurement.
4. Make sure cuff and heart are at same level, otherwise hydrostatic pressure will offset the
NIBP value.
Rev. 4.00 88
8. Patient may have a weak pulse.
1) Comfortably seated
2) Legs uncrossed
5) Middle of the CUFF at the level of the right atrium of the heart
a recommendation that 5min should elapse before the first reading is taken
Measurement Limitations
Measurements are impossible with heart rate extremes of less than 40 bpm or greater than 300
bpm, or if the patient is on a heart-lung machine.
• With severe shock or hypothermia that reduces blood flow to the peripheries
• With obesity, where a thick layer of fat surrounding a limb dampens the oscillations coming
from the artery
• On an edematous extremity.
The effectiveness of this sphygmomanometer has not been established in pregnant, including
preeclamptic patients.
Rev. 4.00 89
monitor.
For this reason, it is important to select the correct cuff size for your patient. Cuff sizes are clearly
marked on the cuff. Measure the circumference of your patient’s limb. Use only Bionet cuffs with
your monitor.
Warning
Warning
As the value of NIBP can vary according to the age and sex of a patient, the user needs to
set up correct data in parameter Menu before measurement. Make certain tubes between
the cuff and the monitor are not kinked or blocked.
Pay attention to not block connecting hose when you put cuff on patient.
Check cuff and hose connection for leaks periodically. Measurements can be inaccurate if air
leaks.
The air pad should be exactly over the branchial artery. Tubing is immediately to the right
or left of the branchial artery to prevent kinking when elbow is bent.
Try to measure infants when they are calm. A kicking or crying baby may disturb or jiggle
the cuff, causing noise within the system and resulting in unstable blood pressure readings.
If necessary, hold the cuffed limb steady, without impeding circulation. Do not hold onto
the cuff and do not pat the cuffed limb to comfort the child.
NIBP cannot be taken under all conditions. Even manual methods, employing a
sphygmomanometer and stethoscope, will not work on unstable or active patients.
Pressurization of the CUFF can temporarily cause loss of function of simultaneously used
monitoring ME EQUIPMENT on the same limb
Ensure the need to check that operation of the NIBP does not result in prolonged
Rev. 4.00 90
impairment of the circulation of the blood of the PATIENT
Status Messages
If the cuff hose is not connected properly →INFLATION FAILURE CHECK CUFF
When the cuff pressure exceeds the set time → OVER TIME CUFF PRESSURE
Rev. 4.00 91
10. EtCO2(*)
Overview
On supported models only(*), the BM Series monitor measures concentrations of end-tidal CO2
(EtCO2) when this option is enabled and the EtCO2 module is connected to your monitor.
The EtCO2 module can perform mainstream measurements in all monitoring modes and
sidestream measurements in the adult and pediatric monitoring modes. For sidestream
measurements, the capnostat fits on the nasal sampling cannula tubing.
EtCO2 connector
CO2
SpO2
T
EtCO2
Connector
CO2
Rev. 4.00 92
Sidestream EtCO2 Accessories
Rev. 4.00 93
Nasal CO2 Sampling Cannula w/ O2
3469INF-00 Neonate
Delivery
Intubation accessories
Rev. 4.00 94
EtCO2 Placements and Accessories (Mainstream, Respironics)
EtCO2 connector
Rev. 4.00 95
Mainstream EtCO2 Accessories
6063-00 Adult/Neonate(disposable)
312-00 Neonate(Disposable)
7053-00 Neonate(Reusable)
Rev. 4.00 96
Precaution
Warning
⚫ The CO2 alarm is not activated until the first breath is detected after the monitor is
turned on or the patient is discharged.
⚫ Accuracy of the CO2 and breathing rate measurements may be impaired due to
improper attachment of the sensor or due to certain patient conditions and certain
environmental conditions.
⚫ If the tube connection is faulty, loose or damaged, gas may leak and the accuracy
of the measurement may be lowered, resulting in poor breathing. To prevent this,
connect all component is securely and check the connection according to standard
clinical procedures to ensure that there are no leaks.
Warning
Sampling method
1. Insert the CAPNOSTAT 5 CO2 Sensor connector into the receptacle of the host monitor as
shown in Figure 1.
Rev. 4.00 97
2. Make sure the arrows on the connector are at the top of the connector and line up the two
keys of the connector with the receptacle and insert.
3. To remove the connector, grasp the body portion of the connector back and remove.
Rev. 4.00 98
Connecting the LoFlo Sample Kit
1. The sample cell of the sampling kit must be inserted into the sample cell receptacle of the
LoFlo CO2 Module as shown in Figure 1. A “click” will be heard when the sample cell is properly
inserted.
2. Inserting the sample cell into the receptacle automatically starts the sampling pump.
3. To remove the sampling kit sample cell from the sample cell receptacle, press down on the
locking tab and pull the sample cell from the sample cell receptacle.
Rev. 4.00 99
Display
② ① ③
EtCO2 CO2 concentration alarm upper and lower limit value display
①
EtCO2 setup
A. EtCO2 menu
ETCO2-CO2 INVALID
ETCO2-OVER RANGE
ETCO2-ZERO REQUIRED
ETCO2-SYSTEM FAULT
ETCO2-TEMP UNSTABLE
12.5mm/s,
25mm/s
inside
kPa
vol%
A-2-5. Use One Gas Unit Choose to set the pressure unit for ON/OFF
A-4.MODULE INFORMATION
A-3-6.LAST ZERO TIME This is the total time that has elapsed Min. display
with the sensor in service the last zero.
A-3-7.PUMP TOTAL TIME This is the total time the pump has Min. display
been on. (LoFlo only)
A-3-8.PUMP MAX TIME This value indicates the maximum Min. display
rated lifetime of the sampling pump.
(LoFlo only)
A-4.MODULE SETUP
A-4-2. BALANCE GAS This setup mode to setup the gas in ROOM AIR
the measurement.
N2O
the type of gas that is mixed with the
HELIUM
breathing gas measuring
A-4-3. SLEEP MODE Sleep mode is used to save power NORMAL MODE
when the host monitor is in standby
TURNOFF MODE
mode. There are two sleep modes
available for the Capnostat. Using POWER SAVING
This
A-4-8.
function
ZEROis used
TYPE to initiate a ROOM AIR
Capnostat Zero.
For best result, connect the CAPNOSTAT 5 CO2 Sensor to an adapter and wait
2minutesbefore performing the Adapter Zero procedure.
Status Message
Following is a list of some of the message that may appear on the monitor when monitoring CO2.
The message should clear when normal operating criteria are met or a solution is found.
- Solution : Make sure sensor is not exposed to extreme heat(heat lamp etc.)
* SENSOR FAULTY
- Cause: One of the following conditions exist : Capnostat Source Current Failure
- Solution : Check that the sensor is properly plugged in. Reinsert or reset the sensor if
necessary.
* SENSOR WARM UP
- Cause : Sensor under temperature , Temperature not stable, Source Current unstable
- Solution : This error condition is normal at startup. This error should clear when the warm up
is complete.
- Cause : This error occurs whenever the pneumatic pressure is outside the expected range.
- Solution : Check that the sampling line is not occluded or kinked. Replace the sample line
- Solution : To clear, check airway adapter and clean if necessary. If this does not correct the
error, perform an adapter zero. If you must adapter zero more than once, a possible
hardware error may exist.
- Cause : The value being calculated is greater than the upper CO2 limit( 150mmHg )
- Cause: Usually caused when the airway adapter is removed from the Capnostat or when there
is an optical blockage on the windows of the airway adapter. May also be caused
by failure to perform Capnostat zero to when adapter type is changed.
- Solution: To clear, clean airway adapter if mucus or moisture is seen. If the adapter is clean,
perform a Capnostat zero.
Troubleshoot procedure
1. Check the connection between the main unit and the module
2. Check the module line connection with the filter line or airway
3. Replace filter line or airway
4. Service Request
In the following monitoring conditions, the measured values may be inaccurate. Read the
measured values carefully.
1. When using this in an environment of using nitrous oxide gas of high concentration
2. When using this in an environment where abrupt temperature change takes place
Caution
⚫ The measured values may be inaccurate when using this equipment for patients who
have very fast or irregular respiration.
⚫ When measuring CO2 from the patient under the anesthesia, check it when gas mixture
comes in. Otherwise, the measured result values may be inaccurate.
⚫ When using a anesthesia machine that uses a volatile anesthetic, CO2 values may be
inaccurate.
Overview
This function is used to indicate the changes of resistance generated by the changes of
temperature in numbers. The function involves the process of transferring the changes into
electric signals.
SpO2
T
Temperature
CO2 Connector
Display
Note
The minimum measuring time required to obtain accurate readings at the specific
body site is at least 3minutes.
If the measurement site is directly exposed to air, the temperature may be lower
than normal.
sensor.
To measure the ambient temperature, connect the probe to your ankle or wrist.
If the patient is sweating or moving heavily, fix the pads with surgical tape.
Temperature settings
A. Temp menu
Overview
The monitor can print out monitoring data, including trends and alarm data. Recordings
of waveforms are either timed or continuous and print at a recording speed of 25mm/s.
All recordings are identified by the patient’s name, ID as well as the date and time of the
recording request. The monitor can trigger alarm recordings automatically for life-
threatening alarms and limit violations, if the Record function is enabled on the alarm
limits table.
A printer is used to print data onto thermal paper.
Size of the thermal paper roll: 58mm wide x 38mm in diameter any thermal paper of
same size can be used for the printer.
Printer settings
A-1-2. Printer Speed Printer speed can select between 25 and 25 mm/s
50mm/s.
50 mm/s
ETCO2, ECG
A-1-4. Waveform2 Channel 2 waveform select menu
A-1-6. Print From Time This is configuration of printed time in Real Time
Note
During printing time, the wave forms of IBP1, IBP2, ETCO2, M-GAS(D-GAS) on paper look
different from the wave forms on screen. That is the reason that the wave forms on screen
cannot be scaled, but the wave forms on paper can be scaled.
Note
These precautions apply to both unused paper as well as paper that has already been run
through the printer.
• Store in cool, dark locations. Temperature must be below 27°C (80°F). Relative humidity
must be between 40% and 65%.
• Avoid exposure to bright light or ultraviolet sources such as sunlight, fluorescent, and
similar lighting which causes yellowing of paper and fading of tracings.
• AVOID CONTACT WITH: cleaning fluids and solvents such as alcohols, ketones, esters,
ether, etc.
To assure MAXIMUM TRACE IMAGE LIFE, thermal paper should be stored separately in:
manilla folders, polyester or polyimide protectors.
Paper manufacturers advise us that these thermal products should retain their traces
when properly imaged and stored for about 3-5 years.
2
Insert the paper roll offered with the product
into the printing unit. Place the roll in a
proper way so that the printed paper can roll
out upwards.
3
Press the printer window until it is properly
shut. Inaccurate shutting may cause failure
in printing.
Inspection Equipment
You should perform a visual inspection before every use, and in accordance with your
hospital’s policy. With the monitor switched off:
⚫ Examine unit exteriors for cleanliness and general physical condition. Make sure that
the housings are not cracked or broken, that everything is present, that there are no
spilled liquids and that there are no signs of abuse.
⚫ If the EtCO2module is mounted on the monitor, make sure that they are locked into
place and do not slide out without releasing the locking mechanism.
⚫ Inspect all accessories (cables, transducers, sensors and so forth). If any show signs of
damage, do not use.
Switch the monitor on and make sure the backlight is bright enough. Check that screen is at
its full brightness. If the brightness is not adequate, contact your service personnel or your
supplier
Warning
Use of this equipment adjacent to or stacked with other equipment should be avoided
because it could result in improper operation. If such use is necessary, this equipment and
the other equipment should be observed to verify that they are operating normally
Inspection Cables
Examine all system cables, the power plug for damage. Make sure that the prongs of
the plug do not move in the adaptor. If damaged, replace it with an appropriate
Bionet power cord and adaptor.
Inspect the parameter cable and ensure that it makes good connection with the
Monitor. Make sure that there are no breaks in the insulation.
Apply the transducer or electrodes to the patient, and with the monitor switched on,
flex the Patient cables near each end to make sure that there are no intermittent faults
All maintenance tasks and performance tests are documented in detail in the service
documentation
Monitor Tests
Safety checks. Selected tests on the basis of At least once every two years, or as needed,
IEC 60601-1 after any repairs where the power supply is
removed or replaced, or if the monitor has
been dropped
Monitor Maintenance
Check ECG synchronization of the monitor and At least once every two years, or as needed.
defibrillator (only if hospital protocol requires
use of monitor during defibrillation)
Replace backlight (integrated displays only) 35,000 - 40,000 hours (about four years) of
continuous usage, or as needed.
Performance assurance for all measurements At least once every two years, or if you suspect
not listed below. the measurement values are incorrect.
Battery Maintenance
Noise in ECG
- Gel is dry
- Electrodes do not stick well to skin
No
No
No
Temperature malfunction
- If the temperature cannot be measured, check the connection with the equipment
The probe is
Yes Replace the probe
In bad condition?
No
No
The measurements appear lower Yes Loosen the cuff during diagnosis
No
No
EtCO2malfunction
No
The module is
Yes Replace the module
in bad condition?
No
No
No
No
No
No
No
No
Print failure
The paper tray cover is properly shut Yes Shut the cover tight
No
No
Overview
Clean the monitor and all accessories after each patient or daily according to your hospital’s
standard protocol. We recommend the following cleaning solution and procedures. To avoid
contamination and unnecessary damage to the equipment, follow the instructions below.
Bionet does not claim responsibility for the following chemical efficacy, disinfectant method, the
ability of the drug to inhibit bacterial infection, environmental impact, safe handling or
precautions related to use. For more information on these topics, see the information provided by
the detergent manufacturer.
Moisture can damage the monitor and peripherals. (For example, around connectors, EtCO2
modules).
Please read the following instructions carefully before cleaning the basic unit or peripherals.
The following pages contain precautions for cleaning certain equipment and peripherals.
⚫ Do not spray detergent on the monitor or peripheral devices. Wipe it off with a damp
cloth.
⚫ Disinfect the surface with gauze with diluted alcohol.
⚫ Dry thoroughly with a lint-free cloth.
CAUTION
Do not wet or rinse the monitor and accessories. Disconnect the unit from the power source
if you accidentally spilled liquid on the equipment. Contact your technician for stability
before operating the equipment.
To prevent damage to the equipment, do not use sharp tools or abrasives. Never immerse
the electrical connector in water or other liquids. When cleaning, be careful not to let the
Patient’s Cable
⚫ Clean the patient cables with a gauze pad moistened with a soap solution.
⚫ To disinfect patient cables, wipe the cables with a gauze moistened with diluted alcohol
or a glutaraldehyde-based dis-infectant.
⚫ Ethylene oxide is suitable for intensive disinfection (almost sterilization), but it shows that
the service life of cables and lead wires is reduced.
⚫ Dry thoroughly with a lint-free cloth.
CAUTION
Do not use disinfectants that contain phenol as they can spot plastics. Do not autoclave or
clean accessories with strong aromatic, chlorinated, ketone, ether, or ester solvents. Never
immerse electrical connectors.
When cleaning, do not apply excessive pressure or bend the cable unnecessarily. Excessive
pressure can damage the cable.
Clean the electrode cup regularly with a toothbrush. When removing gel-like residues, use a soft
brush with flowing water. Wipe the electrode with a soapy cloth moistened with soapy water.
Reusable SpO2sensor
Clean the SpO2 sensor by wiping it with soapy water soaked gauze. Disinfect the sensor by
wiping with 70% alcohol solution. Dry the sensor completely with a lint-free cloth before applying
to the patient.
Capnostat sensor
Do not use excessive pressure or flex the cables as this can stretch the covering and break the
internal wires.
CAUTION
Never boil or autoclave the cable. Vinyl withstands temperatures up to 100°C but begins to
soften at around 90°C. Handle gently when hot and wipe away from the tip toward the
cable.
CAUTION
Decisions on disinfection should be made by the user organization in accordance with the
integrity of the wires or lead wires.
Note
The equipment should be inspected regularly once a year. For inspection items, refer to the
user manual or service manual.
Carefully inspect the main unit and sensor after cleaning the equipment. Do not use damaged or
old equipment.
Clean the exterior of the equipment at least once a month using a soft cloth moistened with
Make sure that the cables and accessories are free from dust and dirt, then wipe them with a soft
cloth moistened with 40 ° C water. Please wipe it with clinical alcohol at least once a week.
Do not immerse the accessories in liquid or detergent. Also, make sure that no liquid penetrates
the instrument or probe.
Caution
Caution
Warning
·If you suspect the installation or disposition of the external ground wire, operate the equipment
by means of the internal power supply.
·If the unit is not used for a certain period of time, remove the backup battery so safety hazards
do not occur.
Overview
The monitor is not user installable. It must be installed by qualified service personnel.
The monitor is intended to be used for monitoring, recording, and alarming of multiple
physiological parameters of adults, pediatrics, and neonates in health care facilities. The device is
to be used by trained health care professionals.
The monitor is intended for use in health care facilities; the BM3 Monitor is additionally intended
for use in transport situations within the hospital setting.
Much of the information below has been borrowed from the requirements set forth in
the Electromagnetic Compatibility Standard IEC 60601-1-2 for medical electrical
equipment issued by the International Electro technical Commission and is available from
a variety of sources. Although primarily aimed at equipment manufacturers, most of the
information contained here is useful for users interested in medical equipment.
The information contained in this section (such as separation distance) is generally
information about the Bionet Patient Monitor detailed above. The numbers provided
here are not guaranteed, but are provided with reasonable assurance of error-free
operation. This information may not apply to other medical and electrical systems, and
older equipment may be particularly susceptible to interference.
Note
Medical electrical equipment requires special precautions for electromagnetic compatibility and
must be installed and serviced in accordance with the EMC information in this section and in the
operating instructions supplied with the monitor.
Portable and mobile RF communication equipment can affect medical electrical equipment.
Cables and accessories not specified in the user guide are not certified. Using other cables and /
or accessories may adversely affect safety, performance, and electromagnetic compatibility
(increased electromagnetic emissions and reduced immunity).
This equipment should not be used near or on top of other equipment. If you need to
Low amplitude signals such as EEG and ECG are particularly sensitive to interference
from electromagnetic energy. This equipment complies with the tests listed at the
bottom, but does not guarantee complete operation. The "quiet" electrical environment
is better. In general, the greater the distance between electrical equipment, the lower the
likelihood of interference.
The BM3system is intended for use in the electromagnetic environment specified below. The customer
or the user of BM3system should assure that it is used in such an environment
RF emissions Group 1 The BM3system uses RF energy only for its internal
function. Therefore. Its RF emissions are very low
CISPR 11
and are not likely to cause any interference in
nearby electronic equipment
IEC 61000-3-3
The BM3system is intended for use in the electromagnetic environment specified below.
The customer or the user of the BM3system should assure that it is used in such an environment
Electrostatic disc 6kV Contact 6kV Contact Floors should be wood ,conc
harge (ESD) rete or ceramic tile. If floors
8kV Air 8kV Air
are covered with synthetic m
IEC 61000-4-2
aterial, the relative humidity
should be at least30%
Electrical fast 2kV for power supply 2kV for power supply lines
Mains power quality should
lines1kV for input/out
Transient/burst 1kV for input/output lines be that of a typical commerc
put lines
ial or hospital environment.
IEC 61000-4-4
Surge 1kV differential mode 1kV differential mode Mains power quality should
be that of a typical commerc
IEC 61000-4-5 2kV common mode 2kV common mode
ial or hospital environment.
Power frequency 3.0 A/m 3.0 A/m Power frequency magnetic fie
lds should be at levels chara
(50/60Hz)
cteristic of a typical location
Magnetic field in a typical commercial or h
ospital environment.
IEC 61000-4-8
for 5 s
for 5 s
Note: Uт is the a.c. mains voltage prior to application of the test level.
The customer or the user of the BM3system should assure that it is used in such an environment
Test level
Note 1) Uт is the A.C. mains voltage prior to application of the test level.
Note2) At 80 MHz and 800 MHz, the higher frequency range applies.
Note3) These guidelines may not apply in all situations. Electromagnetic propagation is affected b
y absorption and reflection from structures, objects and people.
B Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [V1] V / m.
Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and
BM3 system.
The BM3 system is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The user of the BM3 system can help prevent electromagnetic interference
by maintaining a minimum distance between portable and mobile RF communications equipment
(transmitters) and the BM3 system as recommended below, according to the maximum output power
of the communications equipment.
power (W) of transmitter 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
For transmitters rated at a maximum output power not listed above, the recommended separation
distance (d) in meters (m) can be estimated using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter in watts (W) accordin
g to the transmitter manufacturer.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected b
y absorption and reflection from structures, objects, and people.
Immunity test IEC 60601 Test Level Actual Immunity Level Compliance Level
Radiated RF 3V/m, 80MHz to 2.5GHz 3V/m, 80MHz to 2.5GHz 3V/m, 80MHz to 2.5GHz
IEC 61000-4-3
The BM3system is intended for use in the electromagnetic environment specified below.
The customer or the user of the BM3system should assure that it is used in such an environment
Test level
Note 1) These guidelines may not apply in all situations. Electromagnetic propagation is affected
by absorption and reflection from structures, objects and people.
Note 2) It is essential that the actual shielding effectiveness and filter attenuation of the shielded
location be verified to assure that they meet the minimum specification.
Note
For Type A Professional ME Equipment intended for use in domestic establishment instructions for
use includes a warning:
This ME equipment is intended for use by professional healthcare personnel only.
Warning
Portable RF communications equipment (including peripherals such as antenna cables and external
antennas) should be used no closer than 30 cm (12 inches) to any part of the [ME EQUIPMENT or ME
SYSTEM], including cables specified by the manufacturer
Warning
Use of accessories and cables other than those specified or provided by the manufacturer of this
equipment could result in increased electromagnetic emissions or decreased electromagnetic
immunity of this equipment and result in improper operation
Physical
Indicator 3 LED
Environments
Display TFT-LCD
Display size 8”
Measurement ECG, Heart Rate, Respiration Rate, SpO2, Pulse Rate, Systolic BP,
Diastolic BP, Mean BP, Temperature, EtCO2, FiCO2, Airway
Parameter
Respiration Rate
5-lead :1 channel
Respiration Performance
SpO2 Performance
0 to 69% unspecified
Temperature Performance
C.O. (Option)
TI : 0 ~ 27℃
Product Configuration
3. Disposable electrodes 10 EA
9. Operator`s Manual 1 EA
Option Product
HR 0
NIBP - S 0
NIBP - M 0
NIBP - D 0
NIBP- PR 0
SpO2 0
SpO2-Rate 0
RR 0
T1(ْ C) 0
EtCO2 0
FiCO2 0
AWRR 0
LEAD FAULT 0
CABLE OFF 0
LOW BATTERY 0
HR 0
NIBP - S 0
NIBP - M 0
NIBP - D 0
NIBP- PR 0
SpO2 0
SpO2-Rate 0
RR 0
T1(ْ C) 0
EtCO2 0
FiCO2 0
AWRR 0
LEAD FAULT 0
CABLE OFF 0
LOW BATTERY 0
Parameter Limits
AWRR 10 – 30 10 – 50 15 – 100
EtCO2 25 – 50 25 – 50 25 – 50
Display
Primary ECG II II II
RR(RESP) Lead II II II
Temperature Units ْ C ْ C ْ C
Abbreviations
A
A amps
AC alternating current
ADT adult
AUX Auxiliary
C Celsius
CAL calibration
cm, CM centimeter
D diastolic
DC direct current
DIA diastolic
ECG electrocardiograph
F Fahrenheit
g gram
Hz hertz
Inc incorporated
kg, KG kilogram
L liter, left
LBS pounds
LL left leg
M mean, minute
m meter
MIN, minminute
MM, mm millimeters
mV millivolt
OR operating room
PED pediatric
RESP respiration
RL right leg
RR respiration rate
sec second
V precordial lead
V volt
Symbols
& and
° degree(s)
– minus
# number
% percent
± plus or minus
Approval
Number
Approval Date
Serial Number
Date of Purchase
Hospital Name :
Customer Address :
section Name :
Phone :
Sales Agency
Manufacturer
* The product is manufactured and passed through strict quality control and through inspection.
* Compensation standard concerning repair, replacement, refund of the product complies with
“Consumer’s Protection Law” noticed by Korea Fair Trade Commission.
Website: www.ebionet.com
Website : www.bionetus.com
Schwarzschildstraß e 6