Heyer Vizor 15 - Manual 1.0 en
Heyer Vizor 15 - Manual 1.0 en
Heyer Vizor 15 - Manual 1.0 en
PATIENT MONITORING
Operator’s Manual
Rev. 1.0 – 09/09
Table of contents
1 Details of the Manufacturer .......................................................................................................................... 5
2 Introduction.................................................................................................................................................... 6
2.1 General Warning...................................................................................................................................... 6
2.2 General information ................................................................................................................................. 7
2.3 Screen Display......................................................................................................................................... 9
2.4 Button Functions.................................................................................................................................... 10
2.5 Interfaces............................................................................................................................................... 11
2.6 Built-in Battery ....................................................................................................................................... 13
3 Configuration ............................................................................................................................................... 14
3.1 SIGMA ................................................................................................................................................... 14
3.2 TREND .................................................................................................................................................. 14
3.3 ALARM .................................................................................................................................................. 16
3.4 SETUP................................................................................................................................................... 16
3.5 PATIENT INFORMATION ..................................................................................................................... 17
3.6 RECORDER .......................................................................................................................................... 17
3.7 ABOUT .................................................................................................................................................. 18
4 Alarm ............................................................................................................................................................ 19
4.1 Alarm Modes ......................................................................................................................................... 19
4.1.1 Alarm Level And Setup .................................................................................................................. 19
4.2 Alarm Modes ......................................................................................................................................... 19
4.3 Alarm Verification During Power On ...................................................................................................... 19
4.4 Alarm Cause.......................................................................................................................................... 19
4.5 Alarm Silence Button Function .............................................................................................................. 19
4.6 Parameter Alarm.................................................................................................................................... 19
4.7 When An Alarm Occurs ......................................................................................................................... 20
5 ECG Monitoring ........................................................................................................................................... 21
5.1 General.................................................................................................................................................. 21
5.2 ECG Window ......................................................................................................................................... 24
5.3 ECG Alarm Message ............................................................................................................................. 25
5.4 ECG Cable Cleaning ............................................................................................................................. 26
6 RESP Monitoring ......................................................................................................................................... 27
6.1 General.................................................................................................................................................. 27
6.2 RESP Window ....................................................................................................................................... 27
6.3 RESP Alarm Message ........................................................................................................................... 28
7 SpO2 Monitoring .......................................................................................................................................... 29
7.1 General.................................................................................................................................................. 29
7.2 SpO2 Window ........................................................................................................................................ 32
7.3 SpO2 Alarm Message ............................................................................................................................ 33
7.4 SpO2 Probe Cleaning ............................................................................................................................ 33
8 NIBP Monitoring .......................................................................................................................................... 34
8.1 General.................................................................................................................................................. 34
8.2 NIBP Window ........................................................................................................................................ 36
8.3 NIBP Alarm Message ............................................................................................................................ 37
8.4 NIBP Cuff Cleaning................................................................................................................................ 37
9 TEMP Monitoring ......................................................................................................................................... 38
9.1 General.................................................................................................................................................. 38
9.2 TEMP Window....................................................................................................................................... 38
9.3 TEMP Alarm Message........................................................................................................................... 39
9.4 TEMP Sensor Cleaning And Storage .................................................................................................... 39
10 IBP Monitoring ............................................................................................................................................. 40
10.1 General.............................................................................................................................................. 40
10.2 IBP Window ....................................................................................................................................... 41
10.3 IBP Alarm Message ........................................................................................................................... 43
10.4 IBP Transducer Cleaning................................................................................................................... 44
11 GAS Monitoring (Mainstream) .................................................................................................................... 45
11.1 General.............................................................................................................................................. 45
11.2 GAS Window ..................................................................................................................................... 49
11.3 GAS Alarm Message ......................................................................................................................... 52
11.4 IRMA Sensor Cleaning ...................................................................................................................... 53
12 Cerebral State Monitoring........................................................................................................................... 54
12.1 General.............................................................................................................................................. 54
12.2 CSM On Patient Monitor.................................................................................................................... 54
13 ST Monitoring .............................................................................................................................................. 56
13.1 General.............................................................................................................................................. 56
13.2 ST Analysis Window .......................................................................................................................... 56
13.3 ST Alarm Message ............................................................................................................................ 58
14 ARRYTHMIA Monitoring.............................................................................................................................. 58
14.1 General.............................................................................................................................................. 58
14.2 ARR ANALYSIS Window................................................................................................................... 59
15 RECORDING................................................................................................................................................. 62
15.1 General.............................................................................................................................................. 62
15.2 Recording Type ................................................................................................................................. 62
15.3 Recorder Operation And Status Messages ....................................................................................... 62
15.4 Recorder Paper ................................................................................................................................. 63
15.5 Recorder Status Message ................................................................................................................. 63
15.6 Recorder Cleaning............................................................................................................................. 63
16 Patient Safety............................................................................................................................................... 64
17 Care And Cleaning ...................................................................................................................................... 65
17.1 Cleaning ............................................................................................................................................ 65
17.2 Sterilization ........................................................................................................................................ 65
17.3 Disinfection ........................................................................................................................................ 65
18 Getting Started............................................................................................................................................. 66
18.1 Open The Package And Check ......................................................................................................... 66
18.2 Place The Battery Fuse ..................................................................................................................... 66
18.3 Connect The Power Cables............................................................................................................... 66
18.4 Power On The Monitor....................................................................................................................... 66
18.5 Connect Patient Sensors ................................................................................................................... 66
19 Technical Specification............................................................................................................................... 67
20 Trouble Shooting......................................................................................................................................... 71
21 Warranty....................................................................................................................................................... 72
APPENDIX I .......................................................................................................................................................... 73
APPENDIX II ......................................................................................................................................................... 76
APPENDIX III ........................................................................................................................................................ 81
E-Mail: info@heyermedical.de
Internet: http://www.heyermedical.de
2 Introduction Warning
To prevent EMC effect on the monitor, the
■ For an overall safety instruction, please refer system should not be used adjacent to or
to 2.1 General Warning. stacked with other equipment and that if
■ For an overall introduction to the monitor, adjacent or stacked use is necessary, the
please refer to 2.2 General Information. equipment should be observed to verify normal
■ For various messages displayed on the operation in the configuration in which it will be
screen, please refer to 2.3 Display Screen. used.
■ For basic operating instructions, please refer
Warning
to 2.4 Button Function And Basic
The user must check that equipment and
Operation.
accessories function safely and see that it is in
■ For allocation of interface sockets, please
proper working condition before being used.
refer to 2.5 Peripheral Interfaces.
■ For important facts to be noted during the Warning
battery recharging procedure, please refer to Alarm must be set up according to different
2.6 Built-in Rechargeable Battery. situation of individual patient. Make sure that
audio sounds can be activated when alarm
2.1 General Warning occurs.
Warning Warning
Portable Patient Monitor is intended for clinical Do not use cellular phone in the vicinity of this
monitoring application with operation only equipment. High level of electromagnetic
granted to appropriate medical staff. radiation emitted from such devices may result
in strong interference with the monitor
Warning performance.
Before use, carefully read this manual,
directions for use of any accessories, all Warning
precautions, and all specifications. Do not touch the patient, table nearby, or the
equipment during defibrillation.
Warning
The vital sign monitor is intended for use only Warning
as an adjunct in patient assessment .It must be The equipment and devices connected to it
used in conjunction with clinical signs and should form an equipotential body to ensure
symptoms. effective grounding.
Warning Warning
If the accuracy of any measurement does not The doctor shall consider all well-known side-
seem reasonable, first check the patient's vital effects when using the patient monitor.
signs by alternate means and then check the
Warning
monitor for proper functioning.
There will be some risks of polluting the
Warning environment associated with the disposal of
Do not use the patient monitor during magnetic the device and cables at the end of their useful
resonance imaging (MRI) scanning. Induced lives. The device and accessories shall be
current could potentially cause burns. The disposed in accordance with national laws after
monitor may affect the MRI image, and the their useful lives. Contact your municipality to
MRI unit may affect the accuracy of monitor check where you can safely dispose of old
measurements. batteries.
Warning Warning
Do not place the monitor in any position that Do not expose the system near any local
might cause it to fall on the patient. heating item such as the direct radiation.
Warning Warning
There could be hazard of electrical shock by Do not use one monitor for two or more patient
opening the monitor casing. All servicing and at the same time.
future upgrading to this equipment must be Warning
carried out by personnel trained and
It is possible to increase leakage current when
authorized by manufacturer.
several systems are connected to the patient
Warning simultaneously.
Equipment not suitable for use in the presence
of a flammable anesthetic mixture with air or
with oxygen or nitrous oxide.
Warning
Monitor software is designed in a way that
hazards arising from errors in the software
programmed are minimized.
Warning
Do not connect items not specified as parts of
the monitor.
Warning
Vital sign monitor needs to be installed and put
into service according to the EMC information
provided in the APPENDIX III
General instruction:
Portable Patient Monitor (Figure 1) is
adaptable to adult and neonatal usage. It can
monitor vital signals as ECG, Respiratory Rate,
SpO2, NIBP, Dual IBP, CO2, O2, N2O,
Anesthesia Agent, Dual-TEMP and Cerebral
State Index .It integrates parameter measuring
modules, display and recorder in one device,
featuring in compactness, lightweight and
portability. Built-in battery facilitates
transportation of patient. Large high-resolution
display provides clear view of waveforms.
The POWER switch is on the front panel ( in
Figure 1). Three indicators for power and alarm
and battery are on the front panel of system.
The green indicator lights, when the device is
powered on ( in Figure 1). The ALARM
indicator, flashes or lights when alarm occurs
( in Figure 1).The battery indicator is green,
when the battery is charged otherwise it is
orange. ( in Figure 1). The sockets of the
sensors are at the left side of system. Other
sockets and power plug-in are at the back.
Warning
During the system is powered on, the
indicators light. If all indicators light, it will show
proper functioning of all indicators.
Portable patient monitor performs monitoring Vital sign monitor provides extensive functions
of: as visible & audible alarm, storage and report
printout, trend data, NIBP measurements
ECG Heart Rate (HR) Depending on customer's order, MASIMO or
ECG Waveforms STANDARD modules can be installed on vital
RESP Respiratory Rate (RR) sign monitor optionally.
Respiration Waveform Depending on customer's order, mainstream or
SpO2 Saturation Pulse oximetery sidstream CO2 module can be installed on
(SpO2), Pulse Rate (PR) system optionally.
SpO2 Plethysmogram Vital sign monitor is a user-friendly device with
NIBP Systolic Pressure, Diastolic operations conducted by a few buttons on the
Pressure, Mean Arterial front panel and a rotary knob. Refer to 2.4
Pressure (MAP) Button Functions for details.
TEMP Channel-1 Temperature (T1),
Channel-2 Temperature (T2),
Differential Temperature
between two channels (DT)
IBP Channel-1 IBP (IBP1), Channel-
2 IBP (IBP2)
CO2 EtCO2, FiCO2, AWRR
Multi-gas EtN2O, FiN2O, EtO2, FiO2,
EtAA, FiAA
AA is included 5 anesthesia
agent (DES, ISO, SEV, HAL,
ENF)
CSM CSI%, BS%, SQI%, EMG%
2.3 Screen Display The size of the menu is also fixed, covering the
lowest 2, 3, 4 or 5 waveforms.
Vital sign monitor has a color TFT display. The
patient Parameters, waveforms, alarm Parameter Area
messages, bed number, date, system status Parameters are displayed at a fixed position.
and error messages is displayed on the The monitoring results are displayed in the
screen. Parameter Area. The parameters refresh every
The screen is divided into three areas: Header second, except that the NIBP values refresh
Area; Waveform Area; Parameter Area (Figure each time the measurement is over.
2)
Alarm indicator:
In normal mode, the alarm indicator is not lit.
In alarm mode, the alarm indicator lights or
flashes.
Warning
Always verify the audible and visible (LED)
alarms when monitor powers on.
Please refer to chapter 4 for details.
Header Area:
The Header Area is at top of the screen
displaying operating state of the monitor and
status of the patient.
The parameters in Header Area are bed
number, type of patient (adult or neonate),
current date and time
The above messages appear on the screen
throughout the monitoring process.
Other information of the Header Area comes
up only with respective monitoring status.
They are:
■ Signs indicating the remaining battery
charge
■ "ALARM SILENCE" appears when the
alarm silence button is pressed.
■ "NETWORK" appears when the system is
connected to central system.
Waveform / Menu Area:
All waveforms can be displayed at the same
time. The waveforms from top to bottom are:
ECG, SpO2, IBP1, IBP2, EEG (for 12’’ or
larger) and RESP/CO2/Multi-gas (coming from
ECG module or CO2 module or Multi-gas
module).
Gain, filter and lead of the ECG are displayed
as well .The three dotted lines from top to
bottom show the highest scale, reference scale
and lowest scale of IBP waveform. These
values can be manually set.
All menus in monitor always appear at fixed
areas on the screen. When the menu is
displayed, some waveforms become invisible.
2.4 Button Functions When you move the cursor to a certain item:
1. A menu pops up, by pressing the
All the operations to monitor are executed knob.
through buttons and knob at the right of the 2. You can move the cursor frame to
front panel. The names of the buttons are related parameter in opened menu by
above them. They are (Figure 3): turning the knob.
Rotary Knob 3. You can change the content by
This knob can be used to select and pressing the knob on the special
change settings. Operations can be parameters and choose your setting
performed by turning clockwise, counter and confirm your selection by pressing
clockwise or pressing it down. The square it.
frame that moves with the knob turning is Warning
referred to as “cursor”. Before using the system on the patient, the
user must check the buttons function and be
Power
sure that it is in proper working functionality as
Press to power on or off the system.
described above.
HOME/MENU
Press to call up the HOME WINDOW.
Refer to chapter 3 HOME WINDOW.
START/STOP
Press to inflate the cuff to start a blood
pressure measurement. When measuring,
press again to stop the measurement and
deflate the cuff.
REC/STOP
Press to start a real time recording from
ECG signal and all monitoring parameters.
Press during recording to stop the
recording f.
Freeze
When in normal mode, press to freeze all
waveforms on the screen. When in freeze Fig. 3 - Monitor’s buttons and knob
mode, press to restore the waveform
refreshing.
NOTE:
If new alarm occurs under Alarm Suspension /
Silence state, Suspension / Silence state will
remove.
Alarm Silence
Press to suspend alarm for 120 seconds
and disable all sound signals.
("ALARM SILENCE" appears in the
Header Area). Press this key again to
restore all sound signals and remove the
message.
.
When no menu is displayed, turning the knob
clockwise can locate the cursor at: ECG, NIBP,
SpO2, IBP, EEG and RESP/CO2/Multi gas
Parameter Area of screen.
When the cursor is placed at any area, the
user can change the current setting. When at
any of the last items, related parameters menu
can be called up for setting changes.
Operation is as follows:
2.5 Interfaces
For the verity of operation, different kinds of
interfaces are in different parts of the monitor.
At the right side is the recorder's paper inlet
cover (if the system has a recorder).
At the left side are the connectors to patient
cables and the sensors, as shown in figure 4.
Warning
This symbol means "BE CAREFUL". Refer to
For STANDARD SpO2, the shape of ECG and the manual.
SpO2 connectors are the same. The user
should be note to place the ECG and SpO2 Indicates that the instrument is IEC-601-1 Type
cables in corresponding connectors. CF equipment. The module with this symbol
contains an F-Type isolated (floating) patient
Warning applied part providing a high degree of
protection against shock, and is usable during
It is essential that white sign of ECG connector defibrillation.
on the side panel should be in front of the
white sign of the ECG cable connector. Indicates that the instrument is IEC-601-1 Type
BF equipment which is defibrillator proof. The
Warning module with this symbol contains an F-Type
For STANDARD SpO2, that white sign of SpO2 isolated (floating) patient applied part which
contains an adequate degree of protection
connector on the side panel should be in front against shock, and is suitable for use during
of the white sign of the SpO2 probe connector. defibrillation.
Warning
If DC-INPUT power supply in cars like
ambulances is used (ambulances with
body that is connected to the negative pole
of the battery), for safety requirements, DC
to DC converter with the isolation of
1500VAC (at least), must be used. Using
220V of power supply in ambulances is
recommended. Preparing mentioned DC to
DC converter, please contact technical
Fig. 5 - Rear panel
department of manufacturer.
How to use:
1. Install the VGA slave monitor in the same
room with the patient but keep it away from
the patient for more than 1.5m. The
monitor is intended to be used as an
assistant monitoring device.
3 Configuration
■ For last saved ECG signal, please refer to
3.1 SIGMA
■ For previous value of measured
parameters, please refer to 3.2 TREND.
■ For alarm setting and a alarm volume
adjustment, please refer to 3.3 ALARM
Fig. 6 - HOME window
■ For date and time setting please refer to
3.4 SETUP
Portable patient monitor features flexible
configurations. The configuration is done
through operations on the HOME WINDOW
(figure 6) by pressing the HOME/MENU button
on the front panel of monitor.
3.1 SIGMA
Patient monitor is able to save at the last 160
second ECG signal and it is visible in 10 trace
in SIGMA WINDOW.
Pick "SIGMA" in HOME WINDOW to call up
the following menu: ⇒
In this window there are ECG current settings,
like ECG LEAD, ECG GAIN and SIGMA
SWEEP. Refer to chapter 5 ECG
MONITORING for details.
CALENDAR
Available options are "SOLAR" and
“CHRISTIAN".
DATE
Fig. 8 - Alarm window Set the current date of monitoring
■ PERIODIC TRACE1
Choose the first trace of print out record
while automatic recording.
Available options are ECG, SpO2, IBP1,
IBP2 and RESP
■ PERIODIC TRACE2
Choose the second trace channel of print
out record while automatic recording.
Available options are ECG, SpO2, IBP1,
IBP2, RESP and OFF.
■ PERIODIC INTERVAL
For choosing interval time in periodic
recording mode .Available selections are
15min, 30min, 1h, 2h, 4h, 8h, 12h, 24h and
OFF.
■ ALARM RECORD
While alarm recording for each parameter
is set ON, it automatically starts recording
when alarms happened.
3.7 ABOUT
After choosing "ABOUT" in HOME WINDOW
menu, the following menu will be called up:
NOTE:
To ensure patient safety, all leads must be
attached to the patient.
S (660) = S1 + N1 NOTE:
S (905) = S2 + N2 A pulseoximetry is a early warning device.
R= S1 / S2 Use lab co-oximeter to understand the
patient's condition completely.
Again, R is the ratio of two arterial pulse-added
absorbance signals and its value is used to Warning
find the saturation SpO2 in an empirically Use only the recommended manufacturer
derived equation into the oximeter's software. SpO2 sensor for monitoring. Other SpO2
The values in the empirically derived equation sensors may cause improper monitor
are based upon human blood studies against a performance.
laboratory co-oximeter on healthy adult
volunteers in induced hypoxia studies. Warning
Regarding the selected module, use
accessories specified for each SpO2 module.
The above equations are combined and a
noise reference (N') is determined: Warning
While choosing sensor, consider sensor
N' =S (660) - S (905) × R direction for use, written on the package such
as patient's age and weight or if the sensor is
If there is no noise N' = 0: then S (660) = S reusable or disposable.
(905) × R which is the same relationship for
the traditional pulse oximeter. Warning
Pulseoximetry can overestimate the SpO2
value in the presence of Hb-CO, Met-Hb or dye
The equation for the noise reference is based
dilution chemicals.
on the value of R, the: value being seeked to
determine the SpO2. The MS-7 software Warning
sweeps through possible values of R that ESU wire and SpO2 cable must not be tangled
correspond to SpO2 values between 1% and. up.
100% and generates an N' value for each of
these R values. The S (660) and S (905) Warning
signals are processed with each possible N' Do not use the sensor on extremities with
noise reference through an adaptive arterial catheter or venous syringe.
correlation canceller (ACC) which yields an
output power for each possible value of R (i.e., SpO2 measurement
each possible SpO2 from 1% to 100%). The
result is a Discrete Saturation Transform 1. Turn on the monitor.
TM
(DST ) plot of relative output power versus 2. Attach the sensor to the appropriate site of
possible SpO2 value as shown in the following the patient finger. Refer to Figure 24 for the
figure where R corresponds to SpO2 = 97%: proper method.
3. Plug the connector of the sensor extension
cable into the SpO2 socket on the left side of
the device.
Warning
High ambient light sources such as surgical
lights (especially those with a xenon light
source), bilirubin lamps, fluorescent lights,
infrared heating lamps and direct sunlight can
interfere with the performance of an SpO2
sensor. To prevent interference from ambient
light, ensure that the sensor is properly applied
.and cover the sensor site with opaque
material. Failure to take this action in high
Fig. 23 - MASIMO energy output ambient light conditions may result in
inaccurate measurements.
The DST plot has two peaks: the peak
corresponding to the higher saturation is NOTE:
selected as the SpO2 value. This entire SpO2 module updates SpO2 parameter
sequence is repeated once every two seconds every 1 sec.
on the most recent four seconds of raw data.
The MS'-7 SpO2 therefore corresponds to a
running average of arterial hemoglobin
saturation that is updated every two seconds.
NIBP Measuring
NOTE:
Warning The width of the cuff should be either 40%
■ Before starting a measurement, verify that of the limb circumference (50% for
you have selected a setting appropriate for neonates) or 2/3 of the upper arm length.
your patient (adult or neonate.) The inflatable part of the cuff should be
■ Do not apply the cuff to a limb that has an long enough to encircle 50-80% of the limb.
intravenous infusion or catheter in place. The wrong size of cuff can cause
This could cause tissue damage around the erroneous measurement. If the cuff size is
catheter when infusion is slowed or blocked in question, then use a larger cuff.
during cuff inflation.
3. Connect the cuff to the air hose. The limb Measurement Limitations
chosen for taking the measurement should In different patient conditions, the oscillometric
be placed at the same level as the patient's measurement has certain limitations. The
heart. measurement is in search of regular arterial
pressure pulse. In those circumstances, when
4. Check whether the patient mode is the patient's condition makes it difficult to
appropriately selected. To change the detect, the measurement becomes unreliable
patient mode, choose SETUP from the and measuring time increases. The user
HOME WINDOW, the HOME/SETUP should be aware that the following conditions
WINDOW menu will pop up. Pick could interfere the measurement and make the
ADULT/NEONATE to make necessary measurement unreliable or longer. In some
changes. cases, the patient's condition will make a
5. Select a measurement mode in the NIBP measurement impossible.
WINDOW menu. Refer to the following ● Patient Movement
instructions, "Operation Hints", for details. Measurements will be unreliable or may not be
6. Press the START/STOP button on the front possible if the patient is moving, shivering or
panel to start a NIBP measurement. having convulsions. These motions may
interfere the detection of the arterial pressure
Operation Hints pulses. In addition, the measurement time will
be prolonged.
1. To start a MANUAL measuring:
Press the START/STOP button on the front ● Cardiac Arrhythmia's
panel Measurements will be unreliable and may not
be possible if the patient's cardiac arrhythmia
2. To stop a MANUAL measuring causes an irregular heart beat. Thus the
Repress the START/STOP button on the measuring time will be prolonged.
front panel
● Heart-lung Machine
3. To start AUTO measuring: Measurements will not be possible if the
Select NIBP WINDOW menu and pick AUTO patient is connected to a heart-lung machine.
for measuring interval setting, then press
START/STOP button on the front panel. ● Pressure Changes
Measurements will be unreliable and may not
Warning be possible if the patient's blood pressure
Prolonged non-invasive blood pressure changes rapidly over the period of time during
measurements in Auto mode may be which the arterial pressure pulses are being
associated with ischemia and neuropathy in analyzed to obtain the measurement.
the limb wearing the cuff. When monitoring a
patient, examine the limb frequently for normal ● Severe Shock
color, warmth and sensitivity. If any If the patient is in severe shock or
abnormality is observed, stop the blood hypothermia, measurements will be unreliable
pressure measurements. because of reduced pulsation of the arteries.
■ NIBP UNIT
Pick this item to adjust measurement unit
(Options: mmHg or kPa).
■ ALARM LEVEL
Selectable between 1 and 2. Level 1
represents the most serious case.
■ NIBP ALARM
Pick "ON" to enable NIBP alarm functions Fig. 29 - NIBP list window
such as parameters blinking, audio alarm
and light indicator. Pick "OFF" to disable the By pressing the first left item you can select
alarm functions and there will be a a line of NIBP recorded data and you will be
" "symbol instead of alarm limits in able to delete a line of data in NIBP LIST by
Parameters Area. pressing the "DELETE" (second left item).
■ SYS LIMIT ■ MODULE CHECK
SYS alarm is activated when the systolic Available options are "NIBP MANOMETER",
pressure exceeds adjusted ALARM HIGH "NIBP LEAKAGE", "MODULE SELF TEST",
value or falls below adjusted ALARM LOW "MODULE STOP".
value (min: 30 and max: 240).
NIBP MANOMETER
■ DIA LIMIT Wrap the cuff around a rigid cylinder. Connect
DIA alarm is activated when the diastolic a calibrated reference manometer and a ball
pressure exceeds adjusted ALARM HIGH pump by means of a T-piece connector and
value or falls below adjusted ALARM LOW hoses to the monitor. Set the monitor in "NIBP
value (min: 20 and max: 180). MANOMETER" mode. Inflate the pneumatic
system to 0, 50 and 200 mmHg by ball pump
■ MAP LIMIT
separately. The difference between the
MAP alarm is activated when the mean
indicated pressure of the reference manometer
arterial pressure exceeds adjusted ALARM
and the indicated pressure of the monitor
HIGH value or falls below adjusted ALARM
should not exceed ±3 mmHg.
LOW value (min: 25 and max: 200).
NIBP LEAKAGE
Wrap the cuff around a cylinder of an
appropriate size, and the circumference of the
applied cuff does not exceed that of the
cylinder more than 7%. Set the monitor in 8.4 NIBP Cuff Cleaning
"NIBP LEAKAGE" mode.
The monitor inflates the cuff up to 170mmHg Warning
and keeps it constant for 15 sec. If air leakage Do not press the cuff and tubing with a hot
result is satisfactory, "NIBP LEAK OK" iron.
message is displayed; otherwise you will ■ Cleaning
receive "PNUMATIC LEAK" message. Durable one-piece cuffs may be safely
NOTE: cleaned with a damp cloth (70% alcohol or
These test must only done by personnel 0.5% bleach solution may be used) or
trained and authorized by manufacturer. washed in water (140ºF, 60ºC maximum)
with soap or detergent.
8.3 NIBP Alarm Message ■ Sterilization
Do not use steam or heat to sterilize the cuff.
Alarm occurs when the pressure (SYS. DIA or Gas sterilization may be used if necessary.
MAP) exceeds the alarm limit
■ Disinfection
Audio
Alarm Situation Visual prompt
sound
Glutaraldehyde type liquid disinfectants may
SYS violates ● SYS value be used on durable cuffs. Prolonged used of
adjusted alarm limits blinks
SYS ALARM
or violates lower than ● alarm indicator
Activated these disinfectants at full strength may cause
50mmHg flashes.
● DIA value
discoloration of the white cuff marking.
DIA violates adjusted blinks
DIA ALARM Activated
alarm limits ● alarm indicator
flashes.
MAP violates ● MAP value
adjusted alarm limits blinks
MAP ALARM Activated
or violates lower than ● alarm indicator
30mmHg flashes.
Message Cause
■ IBP1/IBP2 ALARM
Pick "ON" to enable alarm functions such as
Fig. 32 - IBP window parameters blinking, audio alarm and light
indicator. Pick "OFF" to disable the alarm
functions and there will be a " " symbol
■ IBP1/IBP2 UNIT
instead of alarm limits in Parameters Area.
Pick this item to adjust measurement unit.
(Options: mmHg, kPa, cmH2O) ■ IBP1/IBP2 ALARM LEVEL
Selectable between 1, 2. Level 1 represents
■ IBP1/IBP2 LABLE
the most serious case.
Suitable label should be selected, regarding
the place of measurement. The available ■ SYS LIMIT
pressure labels are: SYS alarm is activated when the systolic
pressure exceeds adjusted ALARM HIGH
Label Definition
ART Arterial Blood Pressure
value or falls below adjusted ALARM LOW
LVP Left Ventricle Pressure value.
PAP Pulmonary Artery Pressure
RVP Right Ventricle Pressure
CVP Central Venous Pressure
■ DIA LIMIT
LAP Left Atrium Pressure DIA alarm is activated when the diastolic
RAP Right Atrium Pressure
pressure exceeds adjusted ALARM HIGH
value or falls below adjusted ALARM LOW
Warning
value.
IBP algorithm will vary according to the
selected label. Therefore in the case of ■ MEAN LIMIT
improper label selecting, the accuracy of the MEAN alarm is activated when the mean
measurement may be decreased. pressure exceeds adjusted ALARM HIGH
value or falls below adjusted ALARM LOW
■ IBP SWEEP
value.
Available options for IBP SWEEP are 3, 6,
12.5 and 25mm/s. NOTE:
The alarm High/Low limits for SYS, DIA and
■ IBP GRID
MEAN of ART, LVP, PAP, RVP, CVP, LAP,
Select "ON" to divide each IBP signal to 5
RAP are listed as follow. Note that the CVP,
parts with white dot lines.
LAP and RAP only have MEAN pressure,
■ IBP FILTER therefore the alarm limit are only for MEAN.
In order to have a more clear and detailed
The alarm occurs when the value exceeds the
waveform, 3 filter types can be selected:
set limits.
Available options are 22Hz, 16Hz, and 8Hz.
22Hz: Recommended in normal use and the Min Alarm High Min Alarm High Step
Lable
most clinical situation. It has the most (mmHg) (mmHg) (mmHg)
IBP -50 300 5
measuring accuracy among the called filters. ART -50 300 5
16Hz: When the signal is a bit noisy. LVP -50 300 5
PAP -50 120 1
8Hz: This mode is recommended to reduce RVP -50 100 1
CVP -50 100 1
noise and interface resulted from ESU and LAP -50 100 1
also when the system has a high noise level RAP -50 100 1
or doesn’t have equipotential earth. While
using this filter the measuring accuracy
might be decreased.
■ ALARM
Pick "IBP ALARM" in IBP WINDOW to call
up the following menu:
NOTE:
Since transducers need to be warmed to
achieve the best accuracy it is Fig. 35 - IBP / calib window
recommended to zero the system at least
15 minutes after connecting the IBP
transducer to the system.
NOTE:
Zero procedure should be performed before
starting the monitoring and at least once a
day after each disconnection and
connection of the cable.
Zero the transducer:
1 The transducer should be placed at mid-
heart level.
2 Turn off patient stopcock.
3 The transducer must be vented to
atmospheric pressure.
Fig. 36 - IBP calibration
4 Select < IBP1/IBP2 ZERO > to start
zeroing procedure for each channel.
7. Press the rotary knob to start the in this state. ● Follow hospital
This message can be procedure for
calibration. caused by the dislodging
following reason: catheter.
The message "PLEASE WAIT" will display ● A physiological
condition e.g.
● Follow hospital
procedures for
during the procedure. "IBP1/IBP2 asystole. clotted catheters.
● Transducer turned
CALIBRATION OK" indicates that the off to the patient.
calibration procedure is completed ● A catheter tip lodged
against a vessel
successfully. The last calibration time will be wall.
● A clot on the
saved and displayed in its corresponding catheter tip.
place. IBP1/IBP2
SEARCH
IBP signal can’t be
processed by the
● Check all IBP
measurement
software because the setup is suitable
The following messages may prompt up in signal is weak or less or not.
pulsatile. ● Check patient
CALIB WINDOW: and treat if
necessary.
■ "IBP1/IBP2 NO SENSOR, UNABLE TO
CALIBRATE"
Make sure that the transducer is connected
or not, then start calibration procedure.
■ "IBP1/IBP2 OVERANGE, UNABLE TO
CALIBRATE"
Verify that adjusted pressure in menu and
sphygmomanometer pressure are equal. If
the problem persists, contact after sale
service.
■ "IBP1/IBP2 UNSTABLE PRESSURE,
UNABLE TO CALIBRATE"
Make sure that the transducer is not
attached to the patient or perhaps the tubing
system is hited accidentally .If the problem
persists, contact after sales service.
8. Remove the sphygmomanometer tubing
and extra connector.
Warning Warning
Oxygen sensor for replacement should be Do not use the IRMA adapter if adapter or its
stored in a cold environment (+2°C ~ +8°C) package is damaged and return it to the
and should be taken into operation before the vendor.
expired date printed on the package.
Warning
Replace the oxygen sensor every four months, Use only the recommended IRMA airway
when the system warns to change the sensor adapters for monitoring .Other airway adapters
with "REPLACE O2 SENSOR" message or may cause improper performance. (Refer to
when the oxygen readings are questionable. chapter 20 for detail)
Warning Warning
Use only the recommended oxygen sensor for Do not use the adult/pediatric airway adapter
O2 monitoring .Other oxygen sensors may with infants as the adapter adds 6ml dead
cause improper performance. (Refer to chapter space to the patient circuit.
20 for detail)
Warning
Warning Do not use the infant airway adapter with
Depleted oxygen sensors shall be disposed of adults as this may cause excessive flow
in accordance with local regulations for resistance.
biologically hazardous materials.
The infant airway adapter has specially
Warning designed connectors for minimizing the dead
Do not leave depleted oxygen sensors space and can be used even for very small
mounted in the IRMA probe, even if the probe patients. The infant adapter is available without
is not in use. an oxygen port only.
Warning
Do not try to open the oxygen sensor Preparatory steps for gas measurement
assembly. The oxygen sensor is a disposable (Figure 39-44):
product and contains a caustic electrolyte and 1. Plug the IRMA connector into the bedside
lead. monitor side panel.
Warning
Disposable airway adapters shall not be
reused. Used disposable airway adapters shall
be disposed of in accordance with local
regulations for contaminated and biologically
hazardous fluids.
Pre-use check:
Before connecting the IRMA airway adapter to
the breathing circuit, verify the O2 calibration
by checking that the O2 reading on the monitor
is correct (21%). See Room air calibration
section for instructions on how to perform room
air calibration.
Perform the tightness check of the patient
circuit with the IRMA sensor head snapped on
Fig. 41 - Preparatory step 3
the IRMA airway adapter.
Verify that there has not been any
5. Connect the IRMA airway adapter 15 mm accumulation of gas between the IRMA sensor
female connector to the patient’s endo- head and the XTP windows by checking that
tracheal tube. the CO2 readings on the monitor are correct
before connecting a patient to the breathing
circuit.
Check that the connections have been made
correctly by verifying an actual CO2 waveform
on the monitor display.
NOTE:
There is no drift of measurement accuracy.
NOTE:
Variations in barometric pressure do not
have any effects due to internal barometric
Fig. 42 - Preparatory step 4 pressure compensation.
NOTE:
NOTE: There are no adverse effects on stated
Alternatively, connect an HME (Heat performance due to cycling pressure of up
Moisture Exchanger) between the patient’s to 10 kPa.
endotracheal tube and the IRMA probe. Room air calibration of oxygen sensor:
Placing an HME in front of the IRMA probe Room air calibration of oxygen sensor will be
protects the airway adapter from secretions performed automatically at regular intervals
and effects of water vapour and eliminates whenever the IRMA sensor head is
the need of changing the adapter. It allows disconnected from the IRMA airway adapter.
free positioning of the IRMA probe as well. If IRMA sensor is kept in operation for a long
time period without being disconnected from
the airway adapter, or if the operating
temperature for oxygen sensor changes
significantly, the IRMA sensor will indicate that
a new room air calibration is required and the
message will appear on the screen.
Use the following procedure to perform a room
air calibration of the sensor:
Fig. 43 - HME option
personnel of manufacturer.)
NOTE:
Warning Do not use the IRMA airway adapter with
The device can only be operated by personnel nebulized medications because this may
who have passed professional training and are affect the light transmission of the airway
familiar with this manual. adapter windows.
Warning NOTE:
Don’t use the device in the environment which Do not apply tension to the sensor cable.
contains flammable anesthetic gas.
NOTE:
Warning Do not operate the device at temperature
Before any interpretations are made of outside operating range as a below:
parameters readings and waveforms one, IRMA ICU/OR/OR+: 10~35°C
assure that the multi-gas probe is functioning IRMA AX/AX+: 10~40°C
correctly. Partial obstruction of airway with IRMA CO2: 0~40°C
water can result in distorted waveforms. A leak
in the airway may result in low parameters Warning
measurements. Check the monitor to see if it is Verify sensor detection before starting GAS
functioning properly. monitoring. Unplug the sensor from IRMA
connector to verify that the error message "NO
Warning SENSOR "is displayed.
Measurements can be affected by mobile and
RF communications equipment. It should be
assured that the IRMA sensor is used in the
electromagnetic environment specified.
Warning
Do not place the IRMA airway adapter
between the ET tube and an elbow, as this
may allow patient secretions to block the
adapter windows.
NOTE: Warning
FiAA and EtAA have different alarm ranges For accurate measurements, IRMA sensor
for every anesthesia agent as a follow: should be set zero to room air.
13 ST Monitoring NOTE:
If there are not at least 5 normal complexes
13.1 General in the last 50 beats of ECG signal, the ST
value will not be displayed.
ST segment deviation is defined as the
displacement above or below the isoelectric ST monitoring function is “OFF” as a default.
level. The measurement of deviation compares You can switch it “ON”, when this monitoring is
the isoelectric point to the ST measurement necessary.
point.
When ST monitoring is enabled, current ST
The isoelectric point defines the point of zero
values are trended and can be reviewed on the
voltage (no electrical activity) with a default
TREND window.
position of 80ms from R wave as 0msec in the
horizontal (time) axis. The ST point occurs in NOTE:
the ST segment between J-point and the T Measurement unit of ST segment is “mV”.
wave, at a default position of 110 ms after R
wave. The following figure illustrates a typical
QRS complex.
■ ST LIMIT
ST alarm is activated when the ST segment
value exceeds adjusted ALARM HIGH value
or falls below adjusted ALARM LOW value.
(Range: -2 ~ +2 - step 0.1)
Default for upper limit is +0.2 and for lower
limit is -0.2.
■ EVENT DURATION
Pick this item to determine the time that a
potential ST alarm condition must persist on
ECG waveform before the monitor classifies
it as a valid alarm condition. Fig. 54 - ECG/ST ANALYSIS/DEFAULT POINT window
Available options for EVENT DURATION are
OFF, 15s, 30s, 45s and 60s. The default is As shown above, the DEFAULT POINT
OFF and alarm will be activated immediately WINDOW shows the dominant QRS
if alarm condition happens. complex template. Two vertical lines indicate
the positions of the ISO and ST points.
■ ST REALERN
Pick to start a learning procedure. The ISO: It is the base point, used to indicate the
“RELEARN” message is displayed in the baseline point of the ST analysis. The default
ECG waveform area of the screen. It takes is 80ms.
usually about 20 seconds ST: It is the ST measurement point. The
default is 110ms.
During relearn procedure the following action (Selectable between 5 to 400 ms by step of
will be done: 5ms)
- Blanks average stored dominant QRS The reference point is the position where the
complex currently displayed on the peak of R-wave locates.
DEFAULT POINT Window.
- Learns and identifies the new dominant NOTE:
QRS complex template. It is good clinical practice to check the
- New complex is displayed on DEFAULT position of ISO and ST measuring points
POINT Window. before starting ST monitoring and finishing
learning procedure.
NOTE:
You can do relearn procedure by selecting NOTE:
<ARR RELEARN> in ECG/ARR ANALYSIS In practice, the accurate determination of
window. ISO and ST measuring points requires
careful clinical evaluation.
NOTE:
The monitor automatically begins to learn a NOTE:
reference template whenever you execute The ST measurement point should be
any of the following tasks (If ST ANALYSIS adjusted if patient’s HR or ECG morphology
is ON and there is no technical ECG alarm changes significantly.
active, like CHECK LEAD):
- Turning on the monitor If the template is not established, a horizontal
- Connecting ECG cable. line will display. And if the ST ANALYSIS is
- Changing an ECG lead configuration. “OFF”, the message “ST ANALYSIS KEY IS
OFF” appears in this window.
NOTE: You may select ISO or ST, and then switch the
A yellow vertical marker with “LRN” label knob left or right to move the cursor line. When
On ST in TREND window shows the time in the cursor is at the required position, you may
which the learning procedure has been select the base point or the measurement
done. point.
■ DEFAULT POINT NOTE:
Pick "DEFAULT POINT" in the ST Abnormal QRS complex is not considered
ANALYSIS WINDOW to adjust the position in ST segment analysis.
of both ISO and ST measurement points.
When you change the ST and ISO NOTE:
measuring point on the DEFAULT POINT If pace is on (for patient with pacemaker) or
Window, the monitor recomputes the ST while learning procedure, there is no
deviation value accordingly. waveform in DEFAULT POINT Window and
you can see just ISO and ST line. In this
condition, ST value will not be measured.
NOTE: NOTE:
A red vertical marker with “CHG” label On Arrhythmia monitoring is available for adult
ST in TREND window shows the time in and pediatric patient and it is not
which the measuring point has been recommended for neonates.
changed.
Warning
The ARR monitor can only be operated by
13.3 ST Alarm Message personnel who have passed professional
Alarm limit is activated as a follow: training and are familiar with this manual.
The following table describes available beat 14.2 ARR ANALYSIS Window
classifications:
Pick "ARR ANALYSIS“in the ECG WINDOW to
Arrhythmia Event and Beat Classification call up the following menu:
5 seconds pass without the detection of valid
ECG ASYSTOLE
QRS complex.
Ventricular Fibrillation: The monitor identifies
a sinusoidal waveform with fibrillation
characteristics. (Certain ventricular
tachycardias have sinusoidal waveforms
VFIB ARRHYTHMIA closely resembling those of ventricular
fibrillation. Because of the similarity of these
waveforms, the monitor may classify such
types of ventricular tachycardia as
ventricular fibrillation.)
Ventricular Tachycardia: N or more PVC’s
are detected in a time interval T= (60*(N-
VTAC ARRHYTHMIA
1))/R, where N is defined as the VTAC count
Fig. 56 - ECG/ARR ANALYSIS WINDOW
and R is defined as the VTAC rate.
Ventricular Run: Series of 3 to N-1
RUN ARRHYTHMIA consecutive PVCs with a beat to beat rate ≥
the VTAC rate. ■ ARR ANALYSIS
Accelerated Idioventricular Rhythm: Series Pick this item to enable or disable arrhythmia
AIVR ARRHYTHMIA of 3 or more PVCs with a beat to beat rate
less than the VTAC rate. monitoring. The default is “OFF”. When the
Ventricular Bigeminy: Sequence of beats
BIGEMINY ARRHYTHMIA with the pattern : normal ,PVC ,normal ,PVC,
Arrhythmia monitoring is disabled “PVCs
normal, PVC OFF” is displayed in ECG parameters area.
Ventricular Trigeminy: Sequence of beats
TRIGEMINYARRHYTHMIA with the pattern : normal , normal ,PVC
,normal , normal ,PVC ■ ARR SETUP
COUPLET ARRHYTHMIA
Ventricular Couplet: Sequence of beats with
the pattern : normal, PVC, PVC, normal,
Pick “ARR SETUP” in ARR ANALYSIS
PVC, PVC Window to call up the following menu:
Sinus Tachycardia: N or more consecutive
normal beats, with a beat to beat rate ≥
TACHY rate setting. “N” is the event count
TACHY ARRHYTHMIA
set in the ARR SETUP WINDOW.A PVC or
other abnormal beat breaks the analysis
sequence and restarts analysis.
Sinus Bradycardia: N or more consecutive
normal beats, with an average rate ≤ to
sinus bradycardia rate setting. N” is the
BRADY ARRHYTHMIA event count set in the ARR SETUP
WINDOW. A PVC or other abnormal beat
breaks the analysis sequence and restarts
analysis.
PAUS ARRHYTHMIA Actual R-R interval more than 2.1 times of
the average R-R interval.
FREQUENT PVCs More than N (event count set in the ARR
SETUP WINDOW) PVC per minute.
When ARR analysis is enabled, current PVC The ARR SETUP table allows you to
values are trended every 20 second and can configure arrhythmia monitoring accordingly
be reviewed on the TREND window. to your patient’s needs. All detectable
arrhythmia events listed in the first column of
the table .Using the remaining columns, you TACHY: Selectable between 5 and 12 by
can modify the attributes of each event. step of 1.
Fields that are not applicable for certain BRADY: Selectable between 5 and 12 by
event category are shown with dash symbol, step of 1.
while those that cannot be modified are FREQUENT PVCs: Selectable between 1
ghosted. and 15 by step of 1.
Modifying arrhythmia settings: ● ARCHIVE
1. Scroll the cursor frame to parameters You can determine whether the selected
whose arrhythmia functions you wish to event is stored, recorded automatically or
configure and click. both. You can view stored events on ARR
2. Scroll to the function you wish to modify. EVENT RECALL Window.
(The first column, “ALARM LEVEL “, is STR: Stores selected arrhythmia event.
highlighted when you first click on a REC: Automatically generates a recording of
parameter.) selected event.
3. Click to access settings of the selected STR/REC: Event stored and recorded.(even
arrhythmia function. when event alarm is turned off)
4. Dial through settings and click to confirm OFF: No action if arrhythmia event activates.
your selection.
5. Repeat step 1-4 to configure additional ● ALL ALARM LEVEL
arrhythmia functions or parameters. Press to set the level of all arrhythmia alarms
to the same value.
● ALARM LEVEL
Available options are 1, 2 and OFF to set the ● ALL ARCHIVE
grade of alarm for every arrhythmia event. Press to set all arrhythmia ARCHIVE
(For more detail about alarm levels refer to condition to the same state.
chapter 3.)
Pick "OFF" to disable the alarm functions of ■ ARR EVENT RECALL
selected arrhythmia. Pick " ARR EVENT RECALL” in ARR
ALARM LEVEL for “ASYSTOLE” cannot be ANALYSIS WINDOW to call up the following
modified and always is in level 1. menu:
● RATE
With count, you can determine the point at
which an event call is triggered.
You can’t modify the rate for “ASYSTOLE”
,”VFIB”, ”COUPLET”, ”BIGEMINY”
,”TRIGEMINY”, “PAUS” and “FREQUENT
PVCs”.
“RUN” and “AIVR” derive their settings from
“VTAC” and cannot be modified. They are
included to quantify their derivation, based
on current “VTAC” values.
VTAC: Selectable between 100 and 200 by
step of 10.
RUN: Same as VTAC rate
Fig. 58 - ECG/ARR ANALYSIS /ARR EVENT RECALL
AIVR: ≤ VTAC rate-1
TACHY: Selectable between 100 and 200 by You can review any stored arrhythmia event
step of 10. (maximum 80 events) in this menu.
BRADY: Selectable between 30 and 105 by
step of 5. ■ To review different event pages:
Maximum of 8 arrhythmia events can be
● COUNT displayed in the window simultaneously.
With rate, you can determine the point at When there is more than 8 events, different
which an event call is triggered. pages are available. Pick the most left item
You can’t modify the count for “ASYSTOLE”, to review different pages.
”VFIB”, ”COUPLET”, ”BIGEMINY”,
”TRIGEMINY” and “PAUS”. ■ To select an arrhythmia event:
VTAC: Selectable between 5 and 12 by step Pick the second left item to select an
of 1. arrhythmia event displayed in the window.
RUN: Selectable between 3 and VTACcount
-1 by step of 1.
AIVR: Count≥3
NOTE:
The monitor automatically begins to learn a
reference template whenever you execute
any of the following tasks (If ARR
ANALYSIS is ON and there is no technical
ECG alarm active, like CHECK LEAD):
- Turning on the monitor
- Connecting ECG cable.
- Changing an ECG lead configuration.
NOTE:
Fig. 59 - ECG/ARR ANALYSIS /ARR EVENT RECALL/WAVE window
It is recommended to perform relearn
In this window, waveform and time of procedure under the following conditions:
selected arrhythmia event are displayed as - A lead is reconnected or electrodes
well as the parameter values at the event are repositioned.
time. - Eight hours have passed since last
reference complex learned.
● UP-DOWN - Other significant changes appear on
This option allows you to page up and down the morphology of the patient’s ECG.
to review the waveform and the parameters
of other arrhythmia events.
■ ARR RELEARN
Pick to start a learning procedure. The
“RELEARN” message is displayed in the
ECG waveform area of the screen.
NOTE:
You can do relearn procedure by selecting
<ST RELEARN> in ECG/ST ANALYSIS
window.
NOTE:
In most situations the learning phase takes
about 20 second.
17 Care And Cleaning 3. Don't let the cleaning agent enter into
the chassis of the system.
Before using the monitor, do the following: 4. Don't leave the cleaning agents on any
■ Check if there is any mechanical damage on part of the equipment.
the system and accessories.
The monitor and sensor surface can be
■ Check if all the power cable and accessories
cleaned with hospital-grade ethanol and dried
are firmly connected.
in air or with a clean cloth.
■ Check if all the functions of keyboard and
modules to make sure that the monitor is in
proper condition. 17.2 Sterilization
If you find any damage on the monitor, stop To avoid extended damage to the equipment,
using the monitor on patient, and contact the sterilization is only recommended when
biomedical engineer of the hospital or local stipulated as necessary in the Hospital
after sale service. Maintenance Schedule.
The overall check of the monitor, including the Recommended sterilization material: Activated
safety check, should be performed only by dialdehyde (Cidex).
qualified personnel.
All the checks that need to open the monitor Caution
and the safety check and maintenance should ■ Do not let liquid enter the monitor.
be performed by after sales service. ■ No part of the monitor can be subjected
to immersion in liquid.
Note: ■ Do not pour liquid onto the monitor
It is recommended to calibrate the system during sterilization.
by manufacturer every 2 years. The IBP and ■ Use a moistened cloth to wipe up any
capnography modules should be calibrated agent remaining on the monitor.
every 6 month.
Warning 17.3 Disinfection
If users do not follow a satisfactory
Examples of disinfectants that can be used for
maintenance schedule, the monitor may
the case of monitor are listed below:
become invalid, and human health may be
■ Hydrogen Peroxide 3%
endangered.
■ Alcohol 70%
Note: ■ Isopropanol
To ensure maximum battery life, it is ■ Enpropanol
recommended that, at least once a month,
To avoid extended damage to the equipment,
the monitor be run on battery until it turns
disinfection is only recommended when
itself off and then recharged (for details
stipulated as necessary in the Hospital
about battery care see 2.6).
Maintenance Schedule.
19 Technical Specification
CLASSIFICATION
Protection against electroshock Class I, Type CF for all modules (except Multi-gas module that is BF)
(based on IEC 60601-1)
Mode of operation Continues operation equipment
Harmful liquid proof degree Ordinary equipment (without liquid proof)
Method of sterilization and disinfection Refer to each module's chapters and chapter 17 for detail.
Safety of anesthetic mixture Not suitable for use in the presence of a flammable anesthetic mixture
with air or with oxygen or nitrous oxide.
DISPLAY
ECG
ARRHYTHMIA ANALYSIS
ST ANALYSIS
NIBP
TEMPERATURE
RESPIRATION
Method Impedance
Base resistance 250 -1250 Ohm
Dynamic range 0.2 - 2 Ohm
Breath rate range 6 - 150 BrPM
Accuracy ±2% or 2 BrPM
IBP
Channel 2
Measurement Range SYS -50 ~ 300 mmHg
DIA -50 ~ 300 mmHg
MAP -50 ~ 300 mmHg
Pressure Filter 8 Hz,16 Hz, 22Hz selectable
Press Sensor Sensitivity 5 µV / V / mmHg
Press Sensor Impedance 300 ~ 2500 Ohm
Resolution 1 mmHg
Accuracy 2 % or 2 mmHg each one is greater
Multi-gas (Mainstream)
Note 1: The accuracy specification is valid for all specified environment conditions, and includes effects from the following
interfering gases: N2O, O2, HAL, ISO, ENF, SEV, DES, Ethanol, Isopropyl alcohol, Acetone, Methane, He. See Appendix IV for
effects from water vapour partial pressure on gas reading.
Note 2: The accuracy specification is not valid if more than one gas for IRMA OR and more than two gases for IRMA AX+ are in
the gas mixture.
RECORDER
ALARM
TREND
Sources HR, PVCs, ST, SPO2, NIBP, RR, T1, T2, IBP1 (SYS, DIA, MAP), IBP2
(SYS, DIA, MAP), EtCO2, FiCO2, AWRR (sidestream, mainstream),
EtN20, FiN2O, EtO2, FiO2, EtAA, FiAA (ISO, DES, ENF, HAL, SEV)
Trend time 1, 2, 4, 8, 16, 24 hours
Resolution 20 sec
INPUT/OUTPUT
GENERAL
ENVIRONMENTAL
Temperature Operating: 5 to 40 °C
Storage: -20 to 60 °C
For gas module Operating: 10-35 °C
Storage: -20 to 50 °C
Humidity 20-90 % (non condensing)
Altitude -200 to 3000 m
0044
20 Trouble Shooting
Repairing the internal parts of the monitor must be only done by trained and authorized personnel
of after sale service; otherwise manufacturer will not take any responsibility for any possible
hazard to the patient and the monitor.
Troubleshooting guide is intended to help users to solve minor problems caused by incorrect use
of the monitor or failure of accessories.
When you face any problem, please be sure that you have followed all procedure mentioned in
correct action column before you contact with after sale service.
21 Warranty
1. Within the warranty period we will eliminate free of charge any defects or damages on the device that are shown to be
caused by a manufacturing or material error. The warranty does not include easily breakable parts, e.g. glass or
consumable parts.
2. Warranty services can only claimed upon submission of a delivery note (bill of delivery or invoice); the type and method
of damage remedy (repair or replacement) shall be at the discretion of HEYER MEDICAL AG. Warranty services do not
result in an extension of the warranty period, nor do they entail a new warranty being granted. There is no independent
warranty period for installed spare parts.
3. Excluded from the warranty are: Damages caused by improper use, operating errors, mechanical stress or non-
observance of the operating instructions, as well as damages caused by force majeure or by extraordinary
environmental conditions.
4. Warranty services may only be claimed if proof is submitted to confirm that all service and maintenance work has been
carried out by authorized staff.
5. The warranty includes all faults that impair a faultless functioning of the device on the basis of technical defects of
individual components. The warranty obligation can only be recognized by us if the device has been used properly and
according to its intended use and no repair attempts have been undertaken by the client himself or by third parties. The
warranty claim does not include faults caused by mechanical damages or if the device is being operated with
accessories originating from third parties.
6. The warranty is also void if changes, alterations or repairs are made to the device by persons not authorized to do this.
7. The warranty claim only applies to customers of HEYER MEDICAL AG; it cannot be transferred to third parties.
8. The rejected device is to be shipped back to our plant postage free. In case of a request by our customer service
department, the costs for shipping to the plant are to be initially generally borne by the customer. After successful repair,
we will send the device back freight collect. If HEYER MEDICAL AG confirms the existence of a warranty claim, the
customer will receive reimbursement for the costs of delivery and/or transport of the apparatus. Repair parts that do not
fall under the warranty claim will be billed by us. The shipping of the device to us always counts as a complete
assignment to eliminate all faults and/or replace missing parts, unless the customer expressly excludes partial services.
Additional claims to transfer or reduce and replace damages of any kind in particular also of damages not incurred on
the object of delivery itself are excluded.
APPENDIX I
List of monitor’s parameters (selection and defaults)
3min,5min,10min,15min,30min,1hr
AUTO/MANUAL MANUAL
2hr,4hr,MANUAL
APPENDIX II
Monitor error messages
ECG DEFECT ECG module failure Alarm level 2 Pressing ALARM SILENCE, alarm
The message is blinking will be disabled and ignore this fault.
ECG Heart beat is not detected in Alarm level 1 Pressing ALARM SILENCE, alarm is
ASYSTOLE last 10 seconds. The message is blinking suspended for at least 120s.
CHECK RL OR RL or other leads are not Alarm level 2 Pressing ALARM SILENCE, alarm
ALL properly connected when The message is blinking will be disabled and ignore this fault.
ECG lead is V, aVR, aVF or
aVR.
CHECK LL OR LL or other leads are not Alarm level 2 Pressing ALARM SILENCE, alarm
ALL properly connected when The message is blinking will be disabled and ignore this fault.
ECG lead is I
CHECK LA OR LA or other leads are not Alarm level 2 Pressing ALARM SILENCE, alarm
ALL properly connected when The message is blinking will be disabled and ignore this fault.
ECG lead is II
CHECK RA OR RA or other leads are not Alarm level 2 Pressing ALARM SILENCE, alarm
ALL properly connected when The message is blinking will be disabled and ignore this fault.
ECG lead is III
RESP ERROR MESSAGES
RESP CHECK The RESP leads are not Alarm level 3 Alarm is activated when RR ALARM
LEADS properly connected. The message is blinking is "ON". Pressing ALARM SILENCE,
alarm will be disabled and ignore
this fault.
APNEA Non-respiration condition Alarm level 1 Pressing ALARM SILENCE, alarm is
overruns adjusted time The message is blinking suspended for at least 120s.
SPO2 ERROR MESSAGES
SPO2 NO SPO2 probe is disconnected Alarm level 3 Pressing ALARM SILENCE, alarm
PROBE from the monitor. The message is blinking will be disabled and ignore this fault.
SPO2 PROBE SPO2 probe may be Alarm level 2 Pressing ALARM SILENCE, alarm
OFF detached from the patient The message is blinking will be disabled and ignore this fault.
SPO2 CHECK SPO2 probe is not properly Alarm level 2 Alarm is activated when SPO2
PROBE positioned to the patient The message is blinking ALARM is "ON". Pressing ALARM
SILENCE, alarm is suspended for at
least 120s.
SPO2 HIGH This may be caused by Alarm level 2 Alarm is activated when SPO2
AMBIENT entering environmental light The message is blinking ALARM is "ON". Pressing ALARM
LIGHT into the probe SILENCE, alarm is suspended for at
least 120s.
SPO2 SEARCH SPO2 is not calculable due to
some reasons such as long
time motions.
SPO2 SIGNAL The SPO2 signal amplitude is Alarm level 2 Pressing ALARM SILENCE, alarm is
WEAK too weak or undetectable. The message is blinking suspended for at least 120s.
SPO2 PROBE The SPO2 probe is damaged Alarm level 2 Pressing ALARM SILENCE, alarm
DEFECT The message is blinking. will be disabled and ignore this fault.
NIBP ERROR MESSAGES
SELF-TEST NIBP hard ware module Alarm level is set in Pressing ALARM SILENCE, alarm
FAILED failure NIBP WINDOW. will be disabled and ignore this fault.
The message is blinking
LOOSE CUFF Cuff is completely Alarm level is set in Pressing ALARM SILENCE, alarm
unwrapped, no cuff attached NIBP WINDOW. will be disabled and ignore this fault.
The message is blinking
MODE ERROR Use adult cuff instead of Alarm level is set in Pressing ALARM SILENCE, alarm
neonate cuff or occlusion NIBP WINDOW. will be disabled and ignore this fault.
happened in air way The message is blinking
AIR LEAK Air leak in cuff, tube or Alarm level is set in Pressing ALARM SILENCE, alarm
connector NIBP WINDOW. will be disabled and ignore this fault.
The message is blinking
AIR PRESSURE Unstable pressure value (e.g. Alarm level is set in Pressing ALARM SILENCE, alarm
ERROR kinked hoses) because valve NIBP WINDOW. will be disabled and ignore this fault.
cannot open normally. The message is blinking
SIGNAL WEAK Very weak patient signal due Alarm level is set in Pressing ALARM SILENCE, alarm
to a loosely wrapped cuff or NIBP WINDOW. will be disabled and ignore this fault.
extremely weak pulse from The message is blinking
patient.
RENG Measuring pressure is more Alarm level is set in Pressing ALARM SILENCE, alarm
EXCEEDED than upper limit (255mmHg) NIBP WINDOW. will be disabled and ignore this fault
for adult or (135mmHg) for The message is blinking
neonate
EXCESSIVE Arm movement, noisy signal Alarm level is set in Pressing ALARM SILENCE, alarm
MOTION or irregular pulse(e.g. NIBP WINDOW. will be disabled and ignore this fault.
arrhythmia) The message is blinking
OVER Measuring pressure Alarm level is set in Pressing ALARM SILENCE, alarm
PRESSURE exceeded safe software limit, NIBP WINDOW. will be disabled and ignore this fault.
SENSED 290 mmHg for adult and The message is blinking
145mmHg for neonate.
SIGNAL Large motion artifact that Alarm level is set in Pressing ALARM SILENCE, alarm
SATURATE saturates the amplifier's NIBP WINDOW. will be disabled and ignore this fault.
amplitude handling capability The message is blinking
PNEUMATIC Leakage during leak test Alarm level is set in Pressing ALARM SILENCE, alarm
LEAK NIBP WINDOW. will be disabled and ignore this fault.
The message is blinking
TIME OUT Measuring time exceeds 120 Alarm level is set in Pressing ALARM SILENCE, alarm
seconds for adult or 90 NIBP WINDOW. will be disabled and ignore this fault.
seconds for neonate The message is blinking
SYSTEM Error occurs in pump, A/D Alarm level is set in Pressing ALARM SILENCE, alarm
FAILURE sampling, pressure NIBP WINDOW. will be disabled and ignore this fault.
transducer or software. The message is blinking
NIBP DEFECT NIBP module failure Alarm level is set in Pressing ALARM SILENCE, alarm
NIBP WINDOW. will be disabled and ignore this fault.
The message is blinking
STOP NIBP stop key has been
PRESSED pressed during
measurement.
IBP1/IBP2 This condition occurs when Alarm level 3 Pressing ALARM SILENCE, alarm
STATIC the maximum and minimum The message is blinking will be disabled and ignore this fault.
PRESSURE values of a pulsatile pressure
signal (Just for IBP, ART,
PAP, RVP and LVP labels)
differ by less than 3mmHg.In
this case, only Mean
pressure is displayed in this
state.
This message can be caused
by the following reason:
● A physiological condition
e.g. asystole
● Transducer turned off to
the patient.
● A catheter tip lodged
against a vessel wall.
● A clot on the catheter tip.
IBP1/IBP2 IBP signal can’t be The message is blinking
SEARCHING processed by the software
because the signal is weak
or less pulsatile.
NO ADAPTOR There is no adaptor connect Alarm level 3. Pressing alarm silence, alarm will
to the sensor. The message is blinking be disabled and ignore this fault.
CO2 INVALID. CO2 outside specified Alarm level 2. Pressing alarm silence, alarm will
PLEASE ZERO accuracy range. The message is blinking be disabled and ignore this fault.
O2 INVALID. O2 outside specified Alarm level 2. Pressing alarm silence, alarm will
PLEASE ZERO accuracy range. The message is blinking be disabled and ignore this fault.
N2O N2O outside specified Alarm level 2. Pressing alarm silence, alarm will
INVALID.PLEAS accuracy range. The message is blinking. be disabled and ignore this fault.
E ZERO
AGENT Agent outside specified Alarm level 2. Pressing alarm silence, alarm will
INVALID. accuracy range. The message is blinking. be disabled and ignore this fault.
PLEASE ZERO
ACCURACY Two or more agent are out Alarm level 2. Pressing alarm silence, alarm will
INVALID. of range except O2 The message is blinking. be disabled and ignore this fault.
PLEASE ZERO
O2 PORT Clogged or plugged Alarm level 2. Pressing Alarm silence, alarm is
FAILURE The message is blinking. suspended for at least 120S
REPLACE O2 Replace O2 sensor every 4 Alarm level 2. Pressing alarm silence, alarm will
SENSOR month. The message is blinking. be disabled and ignore this fault.
INVALID Ambient pressure outside Alarm level 2. Pressing alarm silence, alarm will
AMBIENT operating range. The message is blinking. be disabled and ignore this fault.
PRESSURE
INVALID Internal temperature outside Alarm level 2. Pressing alarm silence, alarm will
AMBIENT operation range. The message is blinking. be disabled and ignore this fault.
TEMPERATURE
AA1,AA2 Anesthetic mixture detected Alarm level 2. Pressing Alarm silence, alarm is
AGENT by module The message is blinking. suspended for at least 120s.
MIXTURE
APNEA No breath detect Alarm level 1. Pressing Alarm silence, alarm is
The message is blinking. suspended for at least 120s.
ROOM AIR If the sensor operate for a Alarm level 2. Pressing alarm silence, alarm will
CALIB long time period without The message is blinking. be disabled and ignore this fault.
REQUIRED being disconnected from the
adapter or the operating
temperature for oxygen
sensor changes significantly
NO SENSOR Sensor is disconnected from Alarm level 3. Pressing alarm silence, alarm will
system The message is blinking. be disabled and ignore this fault.
SENSOR Manual setting and if no
STANDBY breath is detected for 30 min
MODE and EtCO2 is less than 4
mmHg for more than 30 min
CSM SQI LOW If the impedance of the white Alarm level 3. Pressing alarm silence, alarm will
or black sensors exceeds The message is blinking. be disabled and ignore this fault.
1kΩ, the SQI will fall
gradually. Poor impedance
conditions may cause the
SQI to fall to 50%. Artefacts
can have many causes: high
frequency instrument, EMG,
etc. are typical causes. If
SQI falls because of
extensive use of high
frequency instrument, it will
rise as soon as the high
frequency instrument is
stopped
CSM If sensor impedance is > Alarm level 3. Pressing alarm silence, alarm will
IMPEDANCE 5kΩ the CSI, BS and EMG The message is blinking. be disabled and ignore this fault.
HIGH will be blanked
CSM LINK OFF CSM module is off or it is on Alarm level 3. Pressing alarm silence, alarm will
but wireless communication The message is blinking. be disabled and ignore this fault.
is not established.
APPENDIX III
EMC
Warning
Use only the recommended bedside monitor accessory. Using the accessory other than in relevant
chapter may cause to increase the EMISSION or decrease the IMMUNITY of system.
Warning
Measurements can be affected by mobile and RF communications equipment. It should be assured
that the bedside monitor is used in the electromagnetic environment specified.
Warning
To prevent EMC effect on the monitor, the system should not be used adjacent to or stacked with
other equipment and that if adjacent or stacked use is necessary, the equipment should be observed
to verify normal operation in the configuration in which it will be used.
Warning
Do not use cellular phone in the vicinity of this equipment. High level of electromagnetic radiation
emitted from such devices may result in strong interference with the monitor performance.
RF emissions
Class B
CISPR 11
The VizOR is suitable for use in all establishments,
Harmonic emissions including domestic establishments and those directly
Class A connected to the public low-voltage power supply
IEC 61000-3-2
network that supplies buildings used for domestic
Voltage fluctuations/ purposes.
flicker emissions Complies
IEC 61000-3-3
<5% UT
(>95% dip in UT)
for 0.5 cycle
40% UT Mains power quality should be that of a
Voltage dips, short
(>60% dip in UT) typical commercial or hospital
interruptions and
for 5 cycles environment. If the user of the VizOR
voltage variations
requires continued operation, it is
on power supply 70% UT recommended that the VizOR be
input lines (30% dip in UT) powered from an uninterruptible power
IEC 61000-4-11 for 25 cycles supply or a battery.
<5% UT
(>95% dip in UT)
for 5 sec
d = 1.17 P
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
a
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios,
amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the
electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured
field strength in the location in which the VizOR is used exceeds the applicable RF compliance level above, the VizOR should be
observed to verify normal operation. If abnormal performance is observed, additional measures may necessary, such as reorienting
or relocating the VizOR.
b
Over the frequency range 150kHz to 80 MHz, field strengths should be less than 3 V/m.
Notes:
Notes: