Urgencia - MonitSV - IRIS Service Manual PDF

PMS8210A (IRIS)
Patient Monitor
SERVICE MANUAL
File No.: M10-FW102

Version: 2.0
Publish Date: Jan. 2011
　
　
Intellectual Property Rights
Shanghai 3F Electronics Co., Ltd. has the copyright of this service manual and
also can require it as confidential data. This manual is only referred to the
maintenance and service of IRIS Vital Sign Monitor. This manual and
intellectual property rights (include copyright) belong to 3F Electronics Co.,
Ltd. Without the written approval of 3F, no one can use, publish or allowing
other people to get the information of this manual at any way. Without the
advanced permission of 3F, no one can take pictures, copy, print or translate
the content into other language.
Announcement
Ø 3F reserves the right of final explanation about this service manual.
Ø 3F reserves the right that update this manual without advanced notice.
Ø 3F reserves the right to change the monitor's specifications without
advanced notice.
Ø 3F doesn't guarantee this manual in any form.
3F is responsible for the effects of safety, reliability, and performance only if:
l Assembly operations, extensions, readjustments, modifications, or
repairing is carried out by 3F technical personnel or 3F's authorized
agent.
l The electrical installation complies with the requirements of the
appropriate government regulations.
l The instrument must be connected to the ground correctly.
l The monitor is used in accordance with the operation manual.
3F is not responsible for the effects of safety, reliability, and performance

when:
l Spare Parts are removed, debugged or readjusted.
l The monitor isn't used in accordance with the operation manual.
　
Guarantee
The range of free service:
The instrument, listed in the range of maintenance item can have the free
service.
The range of paid service:

l For the monitor not included in the free service list but in need of the
maintenance, 3F will charge according to the service.
l If the damage of the maintained monitor is man-made, voltage out of the
required range, or force majored by natural calamities, 3F will charge for
the service even if within warranty period.
3F is not responsible for the direct, indirect, completely damaging or delay in

such condition:
l Using instrument improperly.
l Tearing down, maintaining, debugging the instrument, replacing
components or changing electrical wires by the technician without 3F's
agreement or commission.
　
Essential Guides for the Users
Warning: All Users must read following warnings and guide before
operating the Monitors. Any abnormalities or malfunction of the
monitor or body harms caused by the violations of the operational
guides will not be responsible by our company, nor any warranties
will be made by us.
l The instrument is not therapeutic instrument.

l The instrument must be operated under the direction of the professional
medical staff.
l All of the monitoring parameters are used as a reference and should not be
used as the clinical diagnosis. For abnormalities occurred, clinical methods
should be used to check out the reasons.
l The instrument should not be operated in the circumstance with flammable gas
or corrosive gas.
l Prevent the liquid or electrical conductive substance entering into the
instrument.
l The instrument must be grounded correctly, and the power supply must be in
accordance with the specified requirement.
l Delete all the previous data when monitoring a new patient. Only one patient
once.
l If monitor connects to the other instrument, the leakage circuit must be tested
by qualified biological technician before use, and must accord to IEC 60601-1.
l It can be used on many parts of this monitor together, and the security meets
the demand of IEC 60601-1.
l Make sure the connection is not dangerous to the patient or circumstance
before the monitor connects to the other instrument.
l Must use the defibrillation ECG cable supplied by 3F, or the monitor can’t be
use together with defibrillator.
l Checkout the alarm system periodically.
　
l Do not touch the patient in defibrillation. Otherwise, it may lead to serious injury
or death.
l All cables must be away from patient’
s throat to avoid asphyxia.
l When using together with pacemaker or other electric equipment, all other
parts can’t be connected with patients, except the defibrillation ECG cable
supplied by pacemaker of 3F.
l The high frequency electrical bistoury can’t be touched the electrode when use
it together with the monitor, in order to avoid of burning the patients.
l Forbidden to place the electrode onto the injured or edematous site to prevent
infection.
l Blood pressure measurement mode are forbidden to use in the blood pressure
monitoring or test for neonates to prevent injuries.
l Do not measure the blood pressure on the limbs with catheter or infusion.
Do not put on the cuff at or near the wounded position.
l Local bleeding may be caused when using the blood pressure monitoring in the
patients with severe bleeding tendency. Be careful to use on the patients with
sickle cell disease.
l Forbidden to place the blood oxygen sensor onto the injured skin, edematous
or fragile tissues.
l Discom fort or pain may be caused by the continuous use of the clip type of
blood oxygen sensor especially in patients with micro-circulation disorder.
Better not to place the sensor over 2 hours at the same place.
l Non-disposable accessories should be sterilized before it is used on next
patient to prevent cross infection.
l Opening the apparatus by the unauthorized personnel of our company is
forbidden.
l Don’t need to note the user when the types of the accessories are changed.
l To the disposal of package waste, please deal with by the local waste law.
　
Terms for safety and symbols
The list of the symbols used in this instrument is as follows:
Symbol for “caution, consult accompanying documents”
CE mark, when a device has been past CE test, we must put the CE
mark on the device. And the CE NB number should be after the symbol.
a. This symbol shall be accompanied by the manufacturer’

s serial
number. The serial number shall be after or below the symbol, adjacent
to it;
b. The relative size of the symbol and the serial number are not specified;
c. So far our product serial number is made of seven digits, two digits for
the year and two digits for the month and three digits for sequence
number. So the serial number could be show the date of made.
a. The sym bol shall be accompanied by the name and the address of the
manufacturer, adjacent to the symbol. The address is not required with
the symbol on an immediate container as specified in EN375 AND
EN376, except when the immediate container is also the outer container.
b. The relative size of the symbol and the name and address is not
specified.
a. The symbol shall be accompanied by the name and the address of the
authorized representative in the European Community, adjacent to the
symbol. The address is not required with the symbol on an immediate
container as specified in EN375 AND EN376, except when the
immediate container is also the outer container.
b. The relative size of the symbol and the name and address is not
specified.
　
Smbol for “do not reuse”, “single use”, “use only once”
Symbol for “temperature limitation”
Symbol for “consult instructions for use”, “consult operating instructions”
Symbol for “biological risks”
Defibrillation-proof type CF applied part , on medical equipment to

identify a defibrillation-proof type CF applied part.
Equipotentiality, to identify the terminals which, when connected together,

bring the various parts of an equipment or of a system to the same
potential. Not necessarily being the earth (ground) potential. e.g. for local
bonding.
The symbol indicating separate collection for electrical and electronic

equipment consists of the crossed-out wheeled bin. The symbol must be
printed visibly, legibly and indelibly.
The interface of networking
　
Content
CONTENT
Chapter 1 Complete Appliance Introduction .......................................1-1
1.1 Overview...............................................................................1-1
1.2 Model....................................................................................1-1
1.3 Appearance...........................................................................1-2
Chapter 2 Parameters and Theory.....................................................2-1
2.1 Summary ..............................................................................2-1
2.2 Parameters and Theory.........................................................2-2
2.2.1 ECG............................................................................2-2
2.2.2 Respiratory (RESP) parameters..................................2-3
2.2.3 Noninvasive blood pressure (NIBP) parameters..........2-3
2.2.4 SPO2 parameter.........................................................2-3
2.2.5 Temperature (TEMP) parameters..............................2-4
Chapter 3 Inspection .......................................................................3-1
3.1 System Inspection.................................................................3-1
3.1.1 The checking for appearance and assembling.............3-1
3.1.2 Power on.....................................................................3-1
3.1.3 Configuration...............................................................3-1
3.1.4 Running Normally........................................................3-1
3.1.5 Network function .........................................................3-1
3.1.6 Clock...........................................................................3-2
3.1.7 ECG waveform output.................................................3-2
3.1.8 Long time run..............................................................3-2
3.1.9 Factory settings...........................................................3-2
3.1.10 Safety testing............................................................3-2
3.2 The Testing and Calibration of Parameters............................3-2
3.2.1 ECG and respiratory parameters testing......................3-2
3.2.2 Non-invasive blood pressure parameter test ...............3-3
3.2.3 SPO2 parameters test.................................................3-3
3.2.4 Temperature Parameters Test .....................................3-4
Chapter 4 Maintenance......................................................................4-1
4.1 Malfunction guide..................................................................4-1
4.2. Malfunction List....................................................................4-1
4.2.1 Common faults............................................................4-1
4.2.2 TEMP Function Malfunction ........................................4-2
4.2.3 Infrared Temp Malfunction...........................................4-2
4.2.4 SPO2 Function Malfunction.........................................4-3
4.2.5 ECG Function Malfunction ..........................................4-3
4.2.6 Blood Pressure Function Malfunction..........................4-4
IRIS Service Manual
Content
4.2.7 Other Malfunction........................................................4-5

4.3 System Upgrade Guide.........................................................4-5
4.4 Periodic Check......................................................................4-7
Chapter 5 Installation and Disassembly .............................................5-1
5.1 Installation.............................................................................5-1
5.1.1 Tool.............................................................................5-1
5.1.2 Instrument Incasement Inspection...............................5-1
5.1.3 Electrify Preparation....................................................5-1
5.1.4 Other Attention Items ..................................................5-1
5.2 Disassembly.......................................................................5-2
5.2.1 The Disassembly of the Battery Box............................5-2
5.2.2. Depart the panels.......................................................5-2
5.2.3 The Disassembly of the Front Panel............................5-3
5.2.4 The Disassembly of the Module Board ........................5-7
5.2.5The Disassembly of the Back Panel........................... 5-12
5.2.6 The Disassembly of the Right Plastic Bracket ........... 5-15
5.3 Spare Part List.................................................................... 5-16
Chapter 6 Cleaning............................................................................6-1
6.1 Clean....................................................................................6-1
6.2 Sterilize .................................................................................6-1
6.3 Disinfection...........................................................................6-1
Appendix A Parameters Specification................................................ A-4
A.1 ECG .................................................................................... A-4
A.2 Respiration.......................................................................... A-4
A.3 NIBP.................................................................................... A-3
A.4 SPO2................................................................................... A-4
A.5 Temperature ........................................................................ A-4
IRIS Service Manual

Chapter 1 Complete Appliance Introduction
1.1 Overview
IRIS Vital Sign Patient monitor is one of PMS8 patient monitor series of 3F Medical
Company. It is born on the base of the 3F PMS multi-parameter monitor series. Fully
considered the increasing need of clinical applications, 3F develops IRIS with the
latest technology, making it a newly generated medical electronic product.
IRIS monitor can monitor the patient's vital physiology signals, including: ECG, RESP,
NIBP, SPO2 and TEMP. It can be used for adults, pediatric and neonatal.
IRIS uses 50HZ, 100V or 220V main power supply. The real-time data and
waveform can be displayed on 3.2 inches high definition color LCD and LED. It
displays one or two waveforms and all monitoring parameters, which can be
connected to the central network monitoring system. IRIS can be optionally
equipped with a 50mm thermal-sensitive recorder, or a 8V built-in replaceable &
rechargeable lithium battery. It has many advantages: full parameters, compact size,
clear observation, convenient usage, and can be used for emergency monitoring.
1.2 Model
Trade Model Config
MODEL CONFIGURATION
Name Code Code
210 I(bxt) NIBP, TEMP
220 I(bsx) NIBP, SpO2
PMS8210A IRIS
300 I(bst) NIBP, SpO2, TEMP
400 II(bst) NIBP, SpO2, TEMP, ECG, RESP
500 III(bst) NIBP, SpO2, TEMP, ECG, RESP, etCO2
Note: Model Code 500 is reserved for future use.

Where b, s and t in Config code represent options of NIBP, SPO2 and TEMP.
According to user’
s selection, they may be:
NIBP: b F=3F, S=Suntech

SPO2: s F=3F, N=Nellcor, M=Masimo, x=No SPO2
TEMP: t C=Common, I=Infrared, x=No Temp
IRIS Service Manual 1-1

1.3 Appearance
Picture 1-1 Front panel

① Switch: Power on/off;
② Print Switch: Start/Stop the printer;
③ Measure Blood Pressure: Start/Stop measuring the Blood Pressure;
④ Real-Time Waveform Recording: Freeze/unfreeze the current ECG Waveform;
⑤ Mute switch: Turn Off/On the sound effects;
⑥ Multi-function Key: SD Card storage, and the input of patient data;
⑦ Functional Indicator: Display the status of each function
⑧ Menu Key: Adjusting the system parameters, and the patient data retrospection.
Picture 1-2 Back panel

Chapter 2 Parameters and Theory

2.1 Summary
IRIS adopts parameter signal on the base of parameter modules, and transmits
the result to the main control panel through the switch board, displaying the data and
waveform on the screen. The commands of main control panel and module's
information are also transmitted through the switch board. The switch board can also
transfer the power. The framework of system is demonstrated as below:
Medical
staff
Keyboard
Display Recorder
plate (optional)
Main
Power Control board Net port
(optional)
ECG/
NIBP SPO2 TEMP ETCO2
Respiration (optional)
Patients

2.2 Parameters and Theory

The five parameter modules do the real time monitoring on non-invasive blood
pressure, SpO2, ECG/respiration, (body) temperature through the cuff and cables.
The results are transmitted to the main control panel for processing and displaying,
and input to print by the thermal recorder.
2.2.1 ECG
1 The IRIS main function of ECG:
a) Lead: 3-Lead, 5-Lead
b) Lead measurement: I, II, III, avR, avL, avF, V, CAL
c) Drive by right foot
d) Anti- defibrillation
e) Detection of lead off
f) Magnify dual channel ECG, while process the ECG signal by any two lead
measurement.
2 The processing of ECG signals is achieved by circuit of ECG parameter, and the
circuit is constructed by several parts:
a) Input electric circuit: ECG electrode is connected to the input circuit with the
ECG cable. The main function of the circuit is to protect the input port of ECG,
and signal filter out interference from the outside.
b) Buffer amplifier circuit: complete the ECG signal's impedance transformation to

ensure that ECG has a high input impedance and a low output resistance.
c) Right foot drive circuit: The mid-point of the output buffer amplifier circuit to the
RL of the five lead ECG by reversed amplifying to ensure the human body in an
equipotential state, thereby reducing interference and improve the circuit's
common mode rejection ratio.
d) Lead off Detection: According to lead off caused by a buffer amplifier output
level change, adjust the lead off via comparing device and converted into
TTL-level for single-chip detection.
e) Lead connecting to the circuit: In the single-chip control, enlarge the main
release according to the requirements of connecting different lead electrode
access to the main circuit.
f) Main output circuit: By a standard consisting of three op amp instrumentation

amplifier.
g) Post-processing circuit: The main function is to complete the coupling of ECG

signals, the size of programmable gain, filtering and level shifting, and the
signals amplification to a certain extent into the mode - the digital converters.
2-2 IRIS Service Manual

2.2.2 Respiratory (RESP) parameters

IRIS vital sign monitor RESP measurement method is based on the principle of
impedance. The body chest is up and down when breathe, which is equivalent to
impedance changes between RL and LL, and through the ECG electrode RL and
LL's high-frequency signal into a high-frequency signal. The signal is amplified to
electric-signal output, with changes in respiration, and sent to mode-digital
converters. Respiratory parameters is combined by the respiration electric board
and coupling transformer. Circuit is included by: oscillometry, coupling, detection,
early release, high-gain amplification and so on.
2.2.3 Noninvasive blood pressure (NIBP) parameters

NIBP adopts the theory of pulse oscillometry. Puff the cuff around the upper arm
until the pressure which generated by the cuff interdict the flow of the brachial artery,
and then deflated gradually according to a certain algorithm requirements. As the
pressure reduced, with the beat in the pulse, the arterial blood will generate a pulse
signal. Filter out the pulse signal and enlarge it with a high-pass filter (about 1HZ),
and convert it into digital signal by the A / D. The systolic, diastolic and the mean
blood pressure can measure after the treatment by the single-chip microcomputer.
For neonate, pediatric and adult, we must choose the correct size of the cuff in
order to avoid the measurement error.
Main work mode to NIBP:

1. Adult/Pediatric/Neonate mode: choose according to the body figure, weight and
age.
2. Manual/Auto/Series: Manual measurement also means a single measurement.
Only measured once after choosing the Manual. Auto can measure once in the
selected time intervals, period can be 1, 2, 3, 4, 5, 10, 15, 30, 60, 90, 120, 180,
200 or 280 minutes. Series measurement starts the fast consecutive
measurements in five minutes, and can be effectively measure the blood
pressure changes.
2.2.4 SPO2 parameter

SPO2 is obtained through describing the pulse wave of fingertip, which passing
through the specific algorithm and looking up the clinical data table. The SPO2 probe
is the surveying sensor, built of two light emitter diodes and an electro-optical battery
part. Two light emitter diodes conclude a red diode and an infrared diode. They light
alternately according to certain succession. When fingertip's blood capillary
hyperemia repeatedly along with heart's pump blood, the blood vessel and the
organization absorb the light of the emitter diode, and project on to the solar battery,
the solar battery may sense luminous intensity along with the pulse blood change,
and be formed of changed electrical signal. The ratio of current and alternating
current component is according to the content of oxygen in blood. The correct value
of oxygen saturation degree is obtained though the specific algorithm;
simultaneously the arteries rate may be calculated according to the blood oxygen
pulse profile.

The circuit module of SPO2 mainly includes four parts:

1. Probe parts: Luminescence tubes launch infrared and red radiant to measured
position alternately; phototubes will receive the light into electrical signals.
2. Signal processing parts: The electric signal is amplified by the measuring
amplifier, and after high-pass filter and program -controlled amplification by A/D
conversion to digit. It is through D/A switch to control signal baseline, and
amplify to the communication signal, to get an appropriate pulse wave. A/D
conversion for the digital quantity is processed by SCM.
3. Light emitting diode drivers control parts: led transferring and light degree is
controlled by the sequential circuits and DAC. SCM control the size of the
electric current according to algorithm requirements.
4. SCM parts: conclude by CPU, RAM, ROM and interface circuit.
2.2.5 Temperature (TEMP) parameters

Temperature measurement is to convert the temperature to the electrical signal
by a sensor, enlarge it by the amplifier, and process into data. The circuit is made of
proportional amplifier which is constituted by operational amplifier. Turned into
voltage signal by the thermistor probe, the temperature is magnified and sent to the
A/D converter.
Probe examination electric circuit is constituted to voltage comparator by

operational amplifier. When probe off, the input voltage is lower than the comparison
voltage, and the voltage comparator outputs the low level; when insert the probe, the
input voltage is higher , the voltage comparator outputs the high level.

Chapter 3 Inspection
3.1 System Inspection
Please refer to the “PMS8210A operation manual”for the usual measurement of
IRIS. So here we will not describe in detail. The following steps are to indicate the
main point of the measurement as well as some parts which is not carefully
described.
3.1.1 The checking for appearance and assembling

The appearance is tidy and has no nick. The assembly is tight. Shaking the machine
to observe whether in has leftover thing.
The buttons operate well
Complete marks, with correct content.
Standard configuration and fixed sockets are ok.
Before operating follow steps, please do the oscillation test
3.1.2 Power on
When the power is on, check whether the patient monitor can function properly, the
screen display is OK, and no error message; the two waveforms can show correctly
the parameters are refreshed every second, the tracking time is precise too.
3.1.3 Configuration
Users can setup related function in “MENU”, including the switch of the recorder,
ECG, type of the lead，network bed number setting and the switch of arrhythmia.
3.1.4 Running Normally

When operate any key, the patient monitor can run according to the operation
manual's guidelines.
When rotate or press the knob, the patient monitor can run according to the
operation manual's guidelines.
Operate the patient monitor as the user’ s manual, and check sound and audio alarm
normal or not, alarm -mute and turn off-alarm is working or not.
Check the machine to make sure that the memory function is OK.
3.1.5 Network function

Start Central Station and the bedside monitor, make sure the net is connected, and
the bed number shows correctly.
The transfer of data between IRIS and central station normally.
Central Station receives waveform parameters, alarm level, alarm limits, and the
patient information correctly.
Waveform parameters, alarm level, alarm limits, and the patient information correctly
turned to the central station.
IRIS portable shutdown correctly after the Central Station response time required,
see the relevant technical indicators.
IRIS Service Manual ３－１　

Make the network connection from a certain aspect disconnect the central station
can direct the machine to resume after the networking to connect and work normally,
the time required, see the relevant technical indicators.
3.1.6 Clock
Instructions correctly, walking evenly, not mutation, non-stop.
3.1.7 ECG waveform output

Connect IRIS to ECG lead and simulator, and connect D / A output (chassis behind)
to the oscilloscope (Universal oscilloscope), select the 5V or 1V respectively and
compare oscilloscope waveform with the output waveform of IRIS.
3.1.8 Long time run

After long time run, observe the monitor state, whether it is system halted or stopping
scanning waves.
3.1.9 Factory settings

The initial values set by software, except for the "factory settings" menu.
3.1.10 Safety testing

The test of the protective earthing impedance: the impedance must not exceed 0.2O
between the protective earth terminal in MAINS plug and any accessible MAINS part.
Please refer to the standard of the clause 18 f) of IEC 60601-1+A1+A2.
Earth leakage current: when the MAINS is 250V, the current must not exceed 0.5mA;
under single fault conditions, the current must not exceed 1.0mA. Please refer to the
standard of the clause 19 of IEC 60601-1+A1+A2.
The patient leakage current: when the MAINS is 250V, the current must not exceed
10uA.Please refer to the standard of the clause 19 of IEC 60601-1+A1+A2.
3.2 The Testing and Calibration of Parameters

At least once a year, the following parameters are tested and calibrated in order
to guarantee the accuracy of IRIS. After repair, the various parameters shall
re-calibration.
3.2.1 ECG and respiratory parameters testing

1 Tools
Simulator of human body physiology parameter
2 Test steps
A Connect IRIS to ECG simulator.
B Confirm the number of ECG waveforms on the screen, and accord with the
selection of EC menu.
C Configure the default values of ECG1 l and ECG2 (when ECG2 exist).
D Ensure the waveform of ECG and RESP to be ok.
E Set parameter values of simulator are as follows:
HR = 30 (gain * 4)
RR = 15
３－２　 IRIS Service Manual
F Check to the waveform or values of ECG, RESP, HR and RR, are correct.
G To change the simulator's configuration:
HR = 240
RR = 120
H Check the ECG, RESP, HR, RR values set with the simulator parameter
values consistent.
I If ECG leads is off, IRIS should be reported immediately.
3.2.2 Non-invasive blood pressure parameter test

1 Tools
Non-invasive blood pressure simulator
2 Test steps
Calibration function with the use of non-invasive blood pressure simulator, in
accordance with the "user manual" give the calibration method and calibrated to
determine the accuracy of measurement of blood pressure pump. If the
calibration passes , the following tests are perform ed:
A Simulator and monitor all set adult model.
B In the non-invasive blood pressure simulator select a group of blood
pressure measurement within the scope of value, such as:
NS = 90
NM = 70
ND = 60
C Inspection IRIS portable measuring whether the outcome of the actual
simulator set with consistent value.
D change the simulator set pressure value, re-measurement
3.2.3 SPO2 parameters test
1 Tools
SPO2 Simulator
2 Test steps
A Connect SPO2 Simulator with IRIS.
B Set SPO2 simulator parameter values are as follows:
SPO2 = 98
PR = 70
C Inspection IRIS portable SPO2 and PR display value is consistent with the
simulator. (Note: To observe PR value must be in the ECG heart rate menu
will be selected as the source of PETH.)
D Change in SPO2 Simulator SPO2 and RP settings.
E Check IRIS display value consistent with the settings.

F If SPO2 probe is off, IRIS shall immediately report.
IRIS Service Manual ３－３　

3.2.4 Temperature Parameters Test
1 Tools
Physiological signal simulator
2 Test steps
A Temperature sensor will take a simulator, then an IRIS portable TEMP
mouth. Through the simulator settings: TEMP = 34 ℃.
B Inspection IRIS portable screen shows the value of the TEMP for 34 ℃;
C Change the simulator settings: TEMP = 40 ℃.
D Inspection IRIS portable screen shows the value of the TEMP for 40 ℃.
３－４　 IRIS Service Manual

Chapter 4 Maintenance
4.1 Malfunction guide
During the transport, storage and usage, there is risks damage. If the instrument has
malfunction when using, the problems can be disposed as matrix shows below. If the
malfunction can not be debugged, please contact distributor or service department.
4.2. Malfunction List

4.2.1 Common faults
Symptoms Possible causes of failure Failure Remedy
Cannot start the machine 1.the power board is damaged 1. Replace the power board.
and the power light is off 2.the charging board is damaged 2. Replace the charging
board.
Connect the AC power, The charging board is damaged Replace the charging board.
the light is off
The screen is black when 1.LCD screen is damaged. 1. Replace the LCD screen .
power on 2.LCD board is damaged. 2. Replace the LCD board.
The connect line of LCD Re-plug or replace the
The screen is white when system board is damaged connect line
power on LCD board is damaged Replace the LCD board.
The system board is damaged. Replace the system board.
1. The connect line of LCD 1. Re-plug or replace the
The screen is dim when system board is damaged connect line
power on 2. The system board is 2. Replace the system
damaged. board.
Nixie tube is abnormal LCD board is damaged Replace the LCD board.
The function lights is not 1. LCD board is damaged 1. Replace the LCD board.
2. The system board is 2. Replace the system
light.
damaged. board.
The sound of the speaker
The alarm board is damaged. Replace the alarm board.
is abnormal.
The system time cannot The module battery is damaged Replace the module battery.
be saved. The module board is damaged Replace the module board.
Restart automatically The system board is damaged. Replace the system board.

4.2.2 TEMP Function Malfunction

The error code is only used in blood pressure measurement in this monitor.
Symptoms Possible causes of failure Failure Remedy
The value of 1.The connection of the temp probe

1.Re-plug the temp probe
temperature and the temp plug is not well
2.Replace the temp probe
cannot be read 2.The temp probe is old or damaged
3.Replace the temp plug
or the value is 3.The temp plug is damaged
4. Replace the module
incorrect. 4.The module is damaged.
4.2.3 Infrared Temp Malfunction
Sympoms Possible causes of failure Failure Remedy
Wait for 10seconds until the

System busy
“ear”symbol stop flashing
The battery is empty Replace with a full battery
Put the machine in normal

Data read faild temperature(10°c~40°c) for
30 minutes
Put the machine in normal

Environmental temperature
temperature(10°c~40°c) for
changes quickly.
30 minutes
Environmental temperature Put the machine in normal
exceeds the collectible temperature(10°c~40°c) for
temperature range（10℃~40℃）30 minutes
Take out the battery and
Error number 5,6,7 show that the insert back after 1minute. If
system works abnormally the malfunction remains,
please contact the producer
Check whether the cover is
Collected temperature is above
complete and operate it
the upper limit(42.2℃/108F)
again.
Check whether the cover

Collected temperature is below
and glass are clean and
the lower limit(34℃/93.2F)
operate it again

4.2.4 SPO2 Function Malfunction
Sympoms　 Possible causes of failure　 Failure Remedy　

Cannot check the 1.SPO2 module is damaged 1.replace the SPO2 module
SPO2 module . 2.SPO2 module board is 2.replace the module board
damaged.
Cannot measure 1.the patient moves 1.keep the patient quiet
the SPO2. 2.The light is too strong 2.decrease the light
3.The SPO2 probe is damaged 3.replace the SPO2 module
4.SPO2 plug is damaged. 4.replace SPO2 plug
5.SPO2 module board is 5.replace the module board
damaged.
The red light of 1.The SPO2 probe is damaged 1.replace the SPO2 module
SPO2 probe does 2.SPO2 plug is damaged. 2.replace SPO2 plug
not work.(3F 3.SPO2 module board is 3.replace the module board
SPO2 module) damaged.
4.2.5 ECG Function Malfunction
1.The connection of the electrode

1.Clean the skin
and skin is not well
2.Replace the ECG lead line
No ECG wave 2.The ECG lead line is damaged
3.Replace the ECG plug
3.The ECG plug is damaged
4. Replace the ECG board
4.The ECG board is damaged
1.The connection of electrode is 1.Use the electrode in right way
ECG wave is
wrong 2. Keep the patient quiet
abnormal or
2.Patient moves 3.use the monitor in low
disturbed.
3. Exist strong EMI interference.

4.2.6 Blood Pressure Function Malfunction
Sympoms　 Possible causes of failure　 Failure Remedy　

The blood 1.The connection line of blood 1.re-plug or replace the
pressure cannot pressure module is damaged connection line
puff. 2. The blood pressure board is 2. Replace the blood
damaged.　 pressure board．　
The strength of Set the wrong mode when Change the mode to adult
puff is weak measuring the adult.
1.Cuff tied incorrectly 1.Tie the cuff again
2.Cuff is tied outside the clothes 2.Tie the cuff after taking
3.The patient’ s arm with cuff is off the clothe
Cannot measure moving 3.Keep the patient quiet
the blood 4.Air leakage for the cuff 4.Change the new cuff
pressure or the 5.Air leakage for the plug 5.Replace the plug
error is big. 6.The connection between the cuff 6.Release the tube to
tube and the plug is not tight keep the airway smooth
7.Patients belongs to the one who 7.Take the value
is not allowed to measure blood repeatedly
pressure.
Blood pressure measurement error code table　
Error signification Possible causes of failure Failure Remedy
Code
E06 Cuff error The cuff is not tied. Check the cuff.
E07 Air leakage Pneumatic parts or cuffs 1.replace the cuff
have air leakage. 2.Replace the plug
3.Replace the blood
pressure board
E08 Air pressure 1.cuff is tied too tight or 1.re-tie the cuff
wrong loose 2.Keep the patient quiet
2.patient moves 3.Recharge the blood
3.the blood pressure board pressure board
is damaged.
E09 Signal weak The patient's pulse is weak
E10 Upper The blood pressure is over 1.Tie the cuff again
measurement 255mmHg（neonate is 2.Replace the blood
135mmHg） pressure board
E11 Too much patient moves Keep the patient quiet
motion
E12 Over pressure The accident strength
tested makes the cuff pressure Measure again
over 296mmHg（neonate is
135mmHg）
E13 Signal saturated patient moves Keep the patient quiet

E19 Over time Adult is 120s,neonate is90s Measure again

testing
E0C Test suspend Push the measure button Measure again
when measuring the blood
pressure.
4.2.7 Other Malfunction
The sign of the printer 1.Printer malfunction 1.Replace the printer

is X when the printer is 2.The module board is 2.Replace the module board
installed. damaged.
The printer paper does
Printer malfunction Replace the printer
not move.
1.The lithium battery is
The battery is
damaged 1.Replace the lithium battery
abnormal when lithium
2.The charging board is 2.Replace the charging board
battery is installed.
damaged
connect the net
The menu sets offline Whether it has the IP clash or
Wrong set of the net module. whether the IP is accord the
Not connect to the The net line is loose or center station
center station. damaged Re-plug or replace the net
Router is damaged line
Net module malfunction Change the router
Replace the net module
4.3 System Upgrade Guide

Pre-requisite:
Recommend SanDisk 2GB SD card(We cannot ensure other brand or other capacity
to suit IRIS, esp. the low capacity SD card.)
1. Prepare a 2GB SD card and connect to PC with windows XP or Vista.

2. Select the SD card and format it with FAT / FAT16 (Not FAT32).
3. After format, copy this "Iris.bin" file to SD card and remove the SD from PC. (Make
sure this SD card is well formatted.)

Upgrade Procedures:
1. Turn off the IRIS and insert the SD card.
2. Turn on the IRIS, it will load the upgrade interface and finish the upgrade
automatically.
Afterward the screen will show the upgrade successfully (the indication
sentence:"System Program Update Succeeded! Please Remove SD Card and
Restart. then remove SD card, and turn off IRIS.
3. Turn on the IRIS after upgrade, IRIS will format the internal RAM space and it
requires about 1 minute finishing the format. Afterward, IRIS works as normal.
4. The firmware version and issue date are updated automatically in the menu.

Special Situation:
I. Can't load the upgrade interface directly. --- Pls. make sure the SD card meets all
our requirement and check if it is correctly inserted.
II. White-screen during the upgrade. --- make sure the white screen phenomenon
is stable, waiting more than 30 seconds and turn off the monitor and restart
manually.
III. During the upgrade, the monitor restarts automatically with a reloads of the
upgrade interface. --- It's normal; please wait patiently until the indication of
successful upgrade is shown.
IV. It is white-screen when starting the monitor after the upgrade. --- Upgrade
failure. It
has to be upgraded via USB cable by the factory engineer.
Warning: Make sure power supplier well connected, don't touch any button
during upgrade and wait more than 1 minute to view the upgrade result.
4.4 Periodic Check

The life cycle of the instrument is designed to be 5 years.
Clean the instrument and accessories often.
Check the instrument once a year in its life cycle.
Calibrate all kind of parameters once a year in its life cycle.
Check the accessories once half a year in its life cycle.
If the instrument with battery will not been used for a long time, it needs to be
charged at least once every half a year. Otherwise, the battery performance will be
affected or invalid. The means for charging is to plug the Power cord into the power
socket for about 4~8 hours at least

Chapter 5 Installation
Chapter 5 Installation and Disassembly

5.1 Installation
5.1.1 Tool
M3×200 cross screwdriver sharp-nose plier
5.1.2 Instrument Incasement Inspection

Open the package and take out the incasement list. Check whether the name,
amount and size of the contents are in accord with the list. Attention:
If the customer purchase other accessory, please check one by one.
If the contents are not in accord with the list, please contact the supplier.
If the contents are destroyed in transporting, please keep all packages and contact
the supplier.
5.1.3 Electrify Preparation

Before inserting three cores power line into IRIS CPU power socket, please
check the following items:
whether the electric net and voltage meet the equipment to protect patients and
doctors, please use three cores power lines and three cores sockets. Make sure the
monitor is well grounded and do not use two cores AC power.
When IRIS is operated with other medical equipments in the same time, the
potential equation binding post of IRIS should be well connected with other
equipments’potential equation binding posts .
Do not put IRIS under the casting bags or the place some liquid drops. Avoid
liquid entering the monitor.
5.1.4 Other Attention Items

When IRIS is operated with other medical equipments in the same time, it must
meet the medical instruments switching requests to avoid the overlapping of leakage
current and risks harm ing the patients or medical stuff.
The machine cannot be operated in the condition of flammable anaesthetic.
Otherwise, it may explode.

Chapter 5 Installation
5.2 Disassembly
This chapter describes the disassembly and notes. It can help the professional
persons to operate the monitor.
Remember to remove the AC power line and take out the battery box
before disassembly.
5.2.1 The Disassembly of the Battery Box

Remove the screws of the battery box, open the battery cover and take out the
battery box.

5.2.2. Depart the panels
a. Remove the four screws which fix the panels
b. Remove the connect line which connects the system board and the module
board
Open the button first. Do not pull out by force.

5.2.3 The Disassembly of the Front Panel
5.2.3.1 The Disassembly of the System Board

Pull out the three lines and remove the seven screws
alarm board
system
board
Pull out the lock button and remove the

line. Do not pull out by force.

system
board
Note: the replaced system board should

be in the same site. Stick the insulation
panel.

5.2.3.2 The Disassembly of the LCD Screen and LCD Board

a. The Disassembly of the LCD Board
remove the two screws and take out the LCD Board
b. The Disassembly of the LCD Screen

pull out the two lines to separate the LCD screen and LCD board
Pull out the lock button and remove

the line. Do not pull out by force.

LCD
screen
LCD
board
The new LCD board should be in the same

site. Stick the insulation panel.

5.2.4 The Disassembly of the Module Board
5.2.4.1 The Separation of the Module Board and the Back Panel
Remove the four screws and separate the module board and the back panel
Remove
the four
screws .
Take
module
away from
base

5.2.4.2 The Disassembly of ECG Module

Remove the four screws and two lines, take out the ECG module
ECG
board

5.2.4.3 The Disassembly of Blood Pressure Module

a. separate the blood pressure metal plate and the module board
Remove the four screws
Remove the five screws.

b. remove the blood pressure module

pull out the four lines
The line
is behind
the SPO2
board.

Remove the four screws and take out the blood pressure board
NIBP
board
5.2.4.4 The Disassembly of the SPO2 Board

Remove the two screws and take out the SPO2 board
SPO2
board

5.2.5The Disassembly of the Back Panel

5.2.5.1The Disassembly of the Power Charge Board
Remove the five screws
Note these five screws
Take out the power board cable
power
charging
board

5.2.5.2 The Disassembly of the Power Board

Remove the screw and take out the power board

5.2.5.3 The Disassembly of the Iport Net Board

Remove the two screws and take out the net board
5.2.5.4 The Disassembly of the WIFI Net Board
Pull out the WIFI module and remove the two screws, then take out the WIFI board.

WIFI net board
WIFI module
5.2.6 The Disassembly of the Right Plastic Bracket
Remove
Remove Remove
Remove the the two
the screw. the screw.
four screws. screws.

SPO2 plug
Temp plug
NIBP plug
ECG plug
5.3 Spare Part List

TYPE PN Des. Pictures
M10-01-020 system board
PCB
assembly
M10-02-020 LCD display board
M10-04-020 alarm board
M10-11-010 Power board
M10-07-020 Module interface

board
M59-01-000 NIBP board

M10-08-010 SPO2 board
M10-09-020 ECG board
G240320LTS 3.5'' inch LCD

Display W
M10-70-060 IRIS Li-Battery

(2200MA)
Battery
M10-70-061 IRIS Li-Battery
(4650MA)
M10-70-010 Front Hous ing
M10-70-040 Back Housing
M10-71-010 Left side Plastic

bracket
M10-71-020 Right side Plastic

Plastic spare bracket
parts
M10-70-012 Front panel
M10-70-021 Front button
M10-70-030 knob cover
M10-45-050 Surface temp cable

Wiring harness
M10-45-300 Infrared temp cable
M10-45-210 Alarm cable

M10-45-010 Knob Assy cable
M10-45-100 LCD display cable
M10-45-090 system FPC cable
M10-45-080 Internal power cable
M10-45-280 SPO2 Conn.
M10-45-220 NIBP board to

Module board cable
M10-45-270 ECG Conn. Cable
M10-45-240 ECG board to

module board cable
M62-01-XXX Power cord

Chapter 6 Clean
Chapter 6 Cleaning
Cleaning IRIS should use appointed method. To avoid the pollution and damage,
please use introduced material. For the safety of the patients, please do not use
destroyed cable, sensor or accessory.
6.1 Clean
Soft fabric is acceptable during the cleaning
The main engine and power can be cleaned by soap, amino, and ethanol –based
material.
ECG cable can be cleaned by soap and amino.
The repeatable cuff can be cleaned by soap, amino, and ethanol –based material.
The repeatable IBP sensor should be cleaned by soap and amino.
The repeatable SPO2 probe should be cleaned by soap, amino, and ethanol –based
material.
The repeatable TEMP probe should be cleaned by soap, and ethanol –based
material.
6.2 Sterilize
Sterilize when it is necessary on the basis of cleanliness,
Ethanol –based and aldehyde-based cleaner should be used when sterilize the main
machine and the power box.
Aldehyde-based cleaner should be used when sterilize the ECG cable.
Ethanol –based and aldehyde-based cleaner should be used when sterilize the
repeatable cuff.
Ethanol –based and aldehyde-based cleaner should be used when sterilize the
repeatable pulse wave probe .
Bleaching agent should be used when sterilize the TEMP probe.
Note:
1. Ethanol –based: Ethanol 70%
2. aldehyde-based: formaldehyde （35~37%）
3. Bleaching agent: Diluted javel water (for washing), the concentration is
500ppm~5000ppm 。Don’t let the liquid flow or soak the machine and the
parts.
4. No liquid should be remained on any surface.
6.3 Disinfection
Disinfection must be applied on the base of cleaning. The antisepsis step is
complex, so it must be operated according to the rules of the hospital for safety.
Generally use ETO gas.

Appendix A Parameters Specification

A.1 ECG
Lead 3 lead(RA,LA,LL) / 5lead(RA,RL,LA,LL,V))
Lead option Monitor lead / standard lead
Gain 5mm/mv, 10mm/mv
Sweep speed 12.5mm/s, 25mm/s, 50mm/s
Wave gain 5%
Range of heart rate monitoring Adult: 20~300 bpm;
Neonate/ Pediatric: 20~350 bpm
Resolution 1 bpm
Precision 20～200 bpm: 5% or ±5bpm;
201～350 bpm: 10%.
Alarm setting The limit of alarm (setup range: 20～350 bpm ),
and leads -off alarm display.
Aalarm mode Audible and visual alarm, and record the data
during alarm for the retrospection
Input resistance ≧5 MO
CMRR ≧89 dB
Heart disorder analysis NO
Anti-polarized voltage ±500 mV
Baseline renewing time <5 s after the defibrillation
ECG mode Mode 1, mode 2, mode 3
Frequency characteristic 0.67Hz-40Hz
Safeguard 4000V high voltage isolation，anti-defibrillation
A.2 Respiration
Measuring method The thorax impedance method (used with ECG lead)
Measuring range 15～120rpm
Resolution 1 rpm
Precision The bigger one between ±2 rpm or ±2 %
Alarm setup Resp rate overruns 、asphyxiation
Alarm method sound light alarm ，and record the alarm status for review
IRIS Service Manual A-1

A.3 NIBP
Method Oscillometric
Application Neonatal, pediatric and adult patients
Measurement Modes
Manual Adaptive or preset cuff inflation
Automatic Host controlled (1-90 minutes as selected by host)
STAT Restarts a new measurement after 5 or 10 second
pause (host selectable); terminates after 5 minutes
Test Mode Provides continuous output of system pressure
Data unit mmHg / kPa optional
Data storage/review 4000 blood pressure value at most
Alarm setup The range is the same as parameter measurement
range of SYS、DIA、MAP
Alarm method Sound light alarm ，and record the alarm status for
review
Measuring range
Adult Mode
SYS 40~260 (mmHg)
DIA 20~200 (mmHg)
MAP 26~220 (mmHg)
Pediatric Mode
SYS 40~160(mmHg)
DIA 20~120(mmHg)
MAP 26~133(mmHg)
Neonate Mode
SYS 40~130(mmHg)
DIA 20~100(mmHg)
MAP 26~110 (mmHg)
Resolution 1 mmHg
Transducer Accuracy ±3 mmHg, over full range
Overpressure limit
Adult/ Pediatric Mode 290(mmHg)
Neonate Mode 150(mmHg)
Puls e Rate 30-220 BPM
Pulse Rate Accuracy ±2% or ±3 BPM, whichever is greater

A.4 SPO2
SpO2
Measuring method double length infrared wave
Measuring Range 0~100%
Alarm setup range 70~100%
Resolution 1%
Precision ±2% (70~100% adult/ Pediatric)
±3% (70~100% neonate)
Unspecified (0~69%)
Pulse rate
Measuring Range 20~250bpm
Alarm setup range 20~250bpm
Precision ±3bpm (Geostationary)
Or ±5 bpm (Campaign)
Sweep speed 12.5mm/s, 25mm/s
Alarm setup SpO2 overruns 、pulse rate overruns
Alarm method Sound light alarm ，and record the alarm status for review
A.5 Temperature
Channel 1
Measuring mode Thermal
Measuring and Alarm Range 0°C~50°C (32～122°F)
Resolution 0.1 °C
Precision ± 0.1 °C
Actualization interval 1 (Sec.)
Average Time Constant < 10 (Sec.)
Data unit °C/ °F

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PMS8210A (IRIS)

File No.: M10-FW102

3F is not responsible for the effects of safety, reliability, and performance

The range of paid service:

3F is not responsible for the direct, indirect, completely damaging or delay in

l The instrument is not therapeutic instrument.

a. This symbol shall be accompanied by the manufacturer’

Symbol for “temperature limitation”

Symbol for “consult instructions for use”, “consult operating instructions”

Symbol for “biological risks”

Defibrillation-proof type CF applied part , on medical equipment to

Equipotentiality, to identify the terminals which, when connected together,

The symbol indicating separate collection for electrical and electronic

The interface of networking

4.2.7 Other Malfunction........................................................4-5

IRIS Service Manual

Chapter 1 Complete Appliance Introduction

Note: Model Code 500 is reserved for future use.

NIBP: b F=3F, S=Suntech

IRIS Service Manual 1-1

Picture 1-1 Front panel

Picture 1-2 Back panel

IRIS Service Manual 1-2

Chapter 2 Parameters and Theory

IRIS Service Manual 2-1

2.2 Parameters and Theory

b) Buffer amplifier circuit: complete the ECG signal's impedance transformation to

f) Main output circuit: By a standard consisting of three op amp instrumentation

g) Post-processing circuit: The main function is to complete the coupling of ECG

2-2 IRIS Service Manual

2.2.2 Respiratory (RESP) parameters

2.2.3 Noninvasive blood pressure (NIBP) parameters

Main work mode to NIBP:

2.2.4 SPO2 parameter

IRIS Service Manual 2-3

The circuit module of SPO2 mainly includes four parts:

2.2.5 Temperature (TEMP) parameters

Probe examination electric circuit is constituted to voltage comparator by

2-4 IRIS Service Manual

3.1.1 The checking for appearance and assembling

3.1.4 Running Normally

3.1.5 Network function

IRIS Service Manual ３－１

3.1.7 ECG waveform output

3.1.8 Long time run

3.1.9 Factory settings

3.1.10 Safety testing

3.2 The Testing and Calibration of Parameters

3.2.1 ECG and respiratory parameters testing

3.2.2 Non-invasive blood pressure parameter test

3.2.3 SPO2 parameters test

E Check IRIS display value consistent with the settings.

IRIS Service Manual ３－３

3.2.4 Temperature Parameters Test

３－４ IRIS Service Manual

4.2. Malfunction List

Symptoms Possible causes of failure Failure Remedy

IRIS Service Manual 4-1

4.2.2 TEMP Function Malfunction

Symptoms Possible causes of failure Failure Remedy

The value of 1.The connection of the temp probe

4.2.3 Infrared Temp Malfunction

Sympoms Possible causes of failure Failure Remedy

IRIS Service Manual ３－１　

IRIS Service Manual ３－３　

３－４　 IRIS Service Manual

Sympoms　 Possible causes of failure　 Failure Remedy　

Sympoms　 Possible causes of failure　 Failure Remedy　