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Neonate Patient Monitor

C60

User Manual

Shenzhen Comen Medical Instruments Co., Ltd.


Copyright
Version: B
Issued Date: 2014/10
Part No046-000090-01
Statements
Our company makes no warranty of any kind with regard to this material, including, but not limited to
the implied warranties of merchantability and fitness for a particular purpose. Our company assumes
no responsibility for any errors that may appear in this document, or for incidental or consequential
damage in connection with the furnishing, performance or use of this material.
No part of this document can be photocopied, reproduced or translated to another language without
prior written consent of our company.
Responsibility of the Manufacturer
Our company only considers itself responsible for any effects on safety, reliability and performance of
the equipment if:
Assembly operations, extensions, re-adjustments, modifications or repairs are carried out by personnel
authorized by our company, and the electrical installation of the relevant room complies with safety
standards, and the instrument is used in accordance with the instructions for use.

Note: This device is not intended for home use.

WARNING :This device is not intended for treatment.

WARNING

A WARNING label advises against certain actions or situations that could result in personal injury or
death.

Note
A NOTE label provides useful information about a function or procedure.

I
Contents

Chapter 1 General Information............................................................................. - 1 -


1.1 General Information ................................................................................................ - 2 -
1.2 Button Functions and Basic Operations............................................................... - 3 -
1.3 Screen display ......................................................................................................... - 4 -
1.4 External Socket ........................................................................................................ - 8 -
1.5 Built-in charge battery ........................................................................................... - 10 -

Chapter 2 Monitor Assembly .............................................................................. - 11 -


2.1 Open Package and Check ....................................................................................- 11 -
2.2 Connect with AC Cable ..........................................................................................- 11 -
2.3 Power on ..................................................................................................................- 11 -
2.4 Connect with Sensor ............................................................................................. - 12 -
2.5 Check Recorder ..................................................................................................... - 12 -

Chapter 3 Syetem Menu ....................................................................................... - 13 -


3.1 PATIENT MANAGE ............................................................................................... - 13 -
3.2 SURVEY SETUP ................................................................................................... - 15 -
3.3 SELECTION ........................................................................................................... - 15 -
3.3.1 ALARM Volume.............................................................................................. - 16 -
3.3.2 HEART BEAT VOLUME ............................................................................... - 16 -
3.3.3 KEY VOL (Keyboard Vol ) ............................................................................ - 16 -
3.3.4 LCD Brightness (LCD LIGHT) ..................................................................... - 16 -
3.4 MONITOR SETUP (Monitor Setting) .................................................................. - 16 -
3.4.1 ALARM SETUP (Alarm Setting) .................................................................. - 17 -
3.4.2 RECORD (Record output setting) ............................................................... - 17 -
3.4.3 TIME SETUP (System Time Setting).......................................................... - 17 -
3.4.4 NURSE CALL SETUP .................................................................................. - 18 -
3.4.5 MODULE SETUP .......................................................................................... - 18 -
3.5 WORK INTERFACE SELECTION ...................................................................... - 18 -
3.6 TREND SCREEN .................................................................................................. - 19 -
3.7 TREND TABLE....................................................................................................... - 19 -
3.8 NIBP RECALL ........................................................................................................ - 20 -
3.9 ASPHYXIA STIMULATE REVIEW ................................................................... - 21 -
3.10 ALM RECALL(Alarm recall) ................................................................................. - 21 -
3.11 WAVE RECALL ...................................................................................................... - 22 -
3.12 INFO (Monitoring Information) ............................................................................. - 23 -
3.13 DRUG CAL ............................................................................................................. - 24 -
3.14 MAINTAIN ............................................................................................................... - 24 -
3.15 DEMO (Password: 5188) ..................................................................................... - 24 -
3.16 SCR LOCK(screen lock) ...................................................................................... - 25 -

Chapter 4 System Work Interface ..................................................................... - 26 -


II
4.1 Work Interface Selection ...................................................................................... - 26 -
4.1.1 STANDARD .................................................................................................... - 26 -
4.1.2 LIST FACE ...................................................................................................... - 26 -
4.1.3 TREND SCREEN .......................................................................................... - 27 -
4.1.4 OxyCRG SCREEN ........................................................................................ - 28 -
4.1.5 BIG FONT INTERFACE ............................................................................... - 29 -

Chapter 5 Recording ............................................................................................. - 30 -


5.1 General Information on the Recorder ................................................................. - 30 -
5.2 Record Type ........................................................................................................... - 30 -
5.3 Operation and Status Information of Recorder ................................................. - 31 -

Chapter 6 Trend ..................................................................................................... - 32 -


6.1 TREND GRAPH (TREND Diagram) ................................................................... - 32 -
6.1.1 Select trend diagrams for various parameters to be displayed: ............. - 32 -
6.1.2 Select 1-hour or 120-hour TREND diagrams: ........................................... - 33 -
6.1.3 Observe TREND diagrams of later or earlier duration: ............................ - 33 -
6.1.4 Change the display zoom ............................................................................. - 33 -
6.1.5 Obtain the TREND data at certain time in the current TREND diagram - 33 -
6.1.6 Operation sample .......................................................................................... - 33 -
6.2 TREND TABLE (TREND Figure) ......................................................................... - 34 -
6.2.1 Select TREND Figures in various resolutions ........................................... - 35 -
6.2.2 Observe earlier or later TREND curves ..................................................... - 35 -
6.2.3 Observe TREND data of various parameters ........................................... - 35 -
6.2.4 Operation sample .......................................................................................... - 35 -
6.3 NIBP RECALL ........................................................................................................ - 35 -

Chapter 7 Drug Calculation & Titration List ................................................... - 37 -


7.1 DRUG CALC .......................................................................................................... - 37 -
7.1.1 Operation method: ......................................................................................... - 37 -
7.2 TITRATION ............................................................................................................. - 39 -
7.2.1 Enter the Titration list: ................................................................................... - 39 -

Chapter 8 Patient Safety ...................................................................................... - 40 -

Chapter 9 ECG Monitoring .................................................................................. - 42 -


9.1 Definition of ECG Monitoring ............................................................................... - 42 -
9.2 Attentions during ECG Monitoring ...................................................................... - 42 -
9.3 Monitoring Procedures.......................................................................................... - 43 -
9.3.1 Preparation ..................................................................................................... - 43 -
9.3.2 Install ECG leads ........................................................................................... - 43 -
9.3.3 ECG lead connection recommended for surgery patients ...................... - 46 -
9.4 ECG Hot Key .......................................................................................................... - 46 -
9.5 ECG Menu .............................................................................................................. - 47 -
9.5.1 ECG setting menu ......................................................................................... - 47 -
III
9.5.2 ECG setting in waveform area..................................................................... - 48 -
9.5.3 ECG setting in measurements..................................................................... - 50 -

Chapter 10 RESP Measurement .................................................................... - 57 -


10.1 Measure RESP ...................................................................................................... - 57 -
10.1.1 How to measure RESP ................................................................................. - 57 -
10.1.2 Setting of RESP monitoring ......................................................................... - 57 -
10.2 RESP Setting menu (RESTP SETUP) ............................................................... - 58 -
10.3 RESP setting in waveform area .......................................................................... - 59 -
10.4 RESP setting in measurements .......................................................................... - 59 -
10.5 Maintenance & Cleaning ...................................................................................... - 60 -

Chapter 11 SpO2 Monitoring ......................................................................... - 62 -


11.1 Definition of SpO2 Monitoring.............................................................................. - 62 -
11.1.1 Principle for Measurement of SpO2 Volume Recording Parameter ....... - 62 -
11.1.2 BOS/Pulse Monitoring .................................................................................. - 62 -
11.2 Precautions in SpO2/Pulse Monitoring ............................................................... - 63 -
11.3 Monitoring Procedures.......................................................................................... - 64 -
11.4 Measurement restriction ....................................................................................... - 66 -
11.5 SpO2 Setting menu................................................................................................ - 66 -
11.6 SPO2 setting in waveform area........................................................................... - 67 -
11.7 SpO2 Setting in measurement menu ................................................................. - 68 -
11.8 Alarms & Reminders ............................................................................................. - 70 -
11.9 Maintenance & Cleaning ...................................................................................... - 70 -

Chapter 12 NIBP Monitoring .......................................................................... - 71 -


12.1 General Information .............................................................................................. - 71 -
12.2 NIBP Monitoring ..................................................................................................... - 71 -
12.2.1 NlBP Measurement ....................................................................................... - 71 -
12.2.2 NIBP Parameter Setting & Adjustment ....................................................... - 75 -
12.3 NIBP setting in parameter area ........................................................................... - 75 -
12.4 NIBP setting in measurements ............................................................................ - 76 -
12.5 NIBP alarm information ........................................................................................ - 79 -
12.6 Maintenance & Cleaning ...................................................................................... - 82 -

Chapter 13 TEMP Monitoring......................................................................... - 84 -


13.1 TEMP Monitoring ................................................................................................... - 84 -
13.2 TEMP setting in parameter area ......................................................................... - 84 -
13.3 TEMP setting in measurements .......................................................................... - 85 -
13.4 Alarm information and prompt information ........................................................ - 86 -
13.5 Maintenance & Cleaning ...................................................................................... - 86 -

Chapter 14 CO2 Monitoring............................................................................ - 88 -


14.1 General information............................................................................................... - 88 -
14.2 Measuring principle and working procedure...................................................... - 88 -
IV
14.3 Operating Instruction for CO2 Connection ......................................................... - 89 -
14.4 CO2 Measurement Procedures ........................................................................... - 91 -
14.5 Measuring Procedure of RESPIRONICS Branded Mainstream and Sidestream
Modules - 91 -
14.6 Measuring Procedure of PHASEIN Branded Sidestream and Mainstream
Analyzers ................................................................................................................................ - 94 -
14.6.1 Measurement Steps ...................................................................................... - 94 -
14.6.2 Check before use .......................................................................................... - 95 -
14.7 CO2 Settings in Parameter Area ......................................................................... - 96 -
14.8 CO2 Settings in Waveform Area ......................................................................... - 97 -
14.9 CO2 Settings in Measurement Setup.................................................................. - 97 -
14.10 Discharging Waste Gases .................................................................................... - 98 -
14.11 Maintenance and Cleaning of RESPIRONICS Branded Mainstream and
Sdestream Modules .............................................................................................................. - 99 -
14.11.1 Common Cleaning ......................................................................................... - 99 -
14.11.2 Airway Adapter for Cleaning Reusable Mainstream Sensor ................... - 99 -
14.11.3 Method for Sterilizing Reusable Adapter.................................................... - 99 -
14.11.4 Sterilization Times for Reusable Airway Adapter ...................................... - 99 -
14.11.5 Zeroing ............................................................................................................ - 99 -
14.12 PHASEIN Branded Mainstream and Sidestream Analyzer Related Information . -
100 -
14.12.1 Zeroing .................................................................................................. - 100 -
14.13 CO2 Module Lighting Information ...................................................................... - 101 -
14.14 Safety Alarm Information .................................................................................... - 101 -
14.14.1 ISA Sidestream Gas Analyzer Safety Warning Information .......... - 101 -
14.14.2 IRMA Mainstream Gas Analyzer Safety Warning Information ...... - 103 -
14.15 Airway Obstruction .............................................................................................. - 104 -
14.16 Discharging Waste Gases .................................................................................. - 104 -
14.17 Consumables ....................................................................................................... - 105 -
14.18 Safety Symbol Information ................................................................................. - 106 -
14.19 Patents and Trademarks .................................................................................... - 107 -
14.20 Maintenance ......................................................................................................... - 107 -
14.21 Cleaning the Analyzer ......................................................................................... - 107 -

Chapter 15 Neonates Awakening Function ............................................. - 109 -


15.1 Neonates Awakening Function .......................................................................... - 109 -
15.2 Connect Awakening Device ............................................................................... - 109 -
15.3 Application Precautions and Procedures ..........................................................- 110 -
15.4 Cleaning .................................................................................................................- 110 -

Chapter 16 Oxygen Concentration Monitoring ....................................... - 111 -


16.1 About Oxygen Concentration ............................................................................. - 111 -
16.2 Connecting Oxygen Sensors .............................................................................. - 111 -
16.3 21% Calibration ....................................................................................................- 112 -
16.4 100% Calibration ..................................................................................................- 113 -
V
16.5 Alarm Settings .......................................................................................................- 113 -
16.6 Oxygen Concentration Measure Procedures ...................................................- 114 -
16.7 Cleaning .................................................................................................................- 114 -

Chapter 17 IBP Monitoring ........................................................................... - 116 -


17.1 General information..............................................................................................- 116 -
17.2 Considerations of IBP monitoring ......................................................................- 116 -
17.3 Monitoring procedure ...........................................................................................- 117 -
17.4 IBP Menu ...............................................................................................................- 118 -
17.4.1 IBP<1,2>setup in the parameter area .......................................................- 118 -
17.4.2 IBP<1,2>setup in the waveform area ....................................................... - 121 -
17.4.3 IBP<1,2>setup in the measurement setup .............................................. - 122 -
17.5 Alarm information and prompt information ...................................................... - 125 -
17.6 Maintenance and Cleaning ................................................................................ - 126 -

Appendix I Accessories ...................................................................................... - 128 -

Appendix II Product Specifications.................................................................. - 130 -

Appendix III Instruction to System Alarm Prompts ..................................... - 134 -

Appendix IV Guidance and Manufacturers Declaration ............................ - 136 -

VI
Revision history
The table below shows major changes and additions in each revision of this manual.

No. Edition Date Description


1 A 2012/10 See edition A of this document
2 B 2014/10 Changed the EC representative and its address as Lotus Medical
Equipment Limited; Add: 26B Cameron Court, Cork Street,
Dublin 8,Ireland; Tel: +00353-1-6571034; Email:
[email protected]

VII
C
Chapte
er 1 Genera
G al Infoormatiion
For information about
a the monnitor, please read
r the Geneeral Informattion on the M
Monitor chapteer.

For introduction on various innformation dissplayed on sccreen, please read the Screeen Display chapter.

For operational methods,


m pleaase read the Button
B Functio
ons and Basicc Operations chapter.

For locations of various


v interffaces, please read
r the Exteernal Interfacees chapter.

For notices
n of usiing the monittor with poweer supply from
m a battery, please
p read thhe Built-in Ch
hargeable
Batttery chapter.

Warning
Thiss monitor is too monitor clinnical patientss, only for docctors and nurrses use.

Warning
Donnt open coveer of the equuipment to avvoid possiblee risks in eleectric shock. Any mainteenance or
upgrrading on thee monitor musst be conductted by servicee personnel trrained and auuthorized by COMEN
Com
mpany.

Warning
Donnt use this monitor
m wheere there aree flammablees such as an
nesthetic ageent, so as to prevent
from
m explosion.

Warning
Userrs before staarting use should
s check
k whether th
he equipmen
nt and its accessories ca
an work
prop
perly and saffety.

Warning
Pleaase make su
ufficient alarrming settinng for each patient in order to prrevent from delayed
therrapy and make sure there is voice efffect during alarming.

Warning
Don
nt use mobille phones aroound the moonitor. Mobille phones willl generate sttrong emissiion fields
and disturb the monitor.

Warning
Durring defibrillation dont touch
t patientts, tables and
d the machin
ne.

Warning

-1-
Equ
uipments intter-connecteed with thee monitor should
s form
m an equal--potential body
b (as
prottective effecttive earthingg).

Warning
o nurses) should ensure safety of pattients under monitoring,, when the monitor
Userrs (doctors or m is
used
d together wiith electrosu
urgical equipments.

1.1 Generral Inform


mation

The portable mullti-parameter monitor is off rich function


ns, applicablee for bedside monitoring on
o adults,
infannts and newbborns.

Thiss monitor caan monitor mainm parameeters includin


ng ECG, RE ESP, SpO2, N NIBP and TEMP.
T It
integgrates parameeter measurem ment modulees, display an tput to build such a solid and light
nd record outp
monnitor. Its replaaceable built--in battery makes
m nience for pattient movemeent and it will clearly
conven
display 7 wavefoorms and all thhe monitoringg parameter information
i o the high-reesolution interface.
on
Attention
IBP and CO2 aree optional.

Fromm left to rightt they are in turn:


t
(1) ALARM IN NDICATOR; (2) Chargingg INDICATO OR; (3) Worrking INDIC CATOR; (4) ON/OFF
buttoon; (5) SIL LENCE buttonn; (6) FREEZ ZE button; (77) PRINT buttton; (8) STA ART button (ffor blood
pressure); (9) MA AIN button (ffor key framee return); (10
0)Knob; (11) MENU; (12)) Parameter area;
a (13)
Wavveform area; (14) Informaation area. Thhe Knob has three workinng methods aas turning leftt, turning
rightt and pressingg to confirm parameters
p arre mainly app
plied to the opperation of m
menu.

The outlet of the recorder is located


l on thee left side off monitor andd AC power liine sockets are
a on the
rear panel of the monitor.

-2-
(14)

(1)

(13) (12)

(2) (11)

(3)
(4) (5) (7) (8) (9) (10)
(6)

Figure 1-1Multi-parameter Monitor

This monitor has rich functions, able to provide various functions such as visual/audio alarming,
TREND storage & output, NIBP measurement save and review, medicine calculation, ST analysis,
pulse analysis, heart rate turbulence analysis, etc.
This monitor has a friendly operation interface, able to provide all functions with the keys and buttons
on the front panel, refer to Function Keys part for details.

1.2 Button Functions and Basic Operations


The monitor can be operated through use of the buttons and knobs. Here are the functions of the
buttons as follows:
(SILENCE button): Press this button and the alarm will be silencefor 3 minutes
(this item can be set in the Alarm Setting menu). Press this button over 1
second and the alarm sound can be shielded. In the information area appears
sign. Repress this button again to pause alarm, resume heart beat sound
and cancel some technical alarm (ECG off, SPO2 off), and the sign
disappears.

(FREEZE button): Press this button and all waveforms on the screen can be
frozen in the normal mode. Press this button once again and the frozen
waveforms can be freed.

(PRINT button): Press this button to start a real-time recording. The recording
length is determined according to the real-time recording time in the
Recorder submenu of Setting menu. Press this button once again in the
-3-
recording process and the recording will stop at once. Each interval of pressing
this button should be greater than 2 seconds and the frequency should not be
excessively high.

To start/stop NIBP measurement, press to inflate the cuff to start a blood


pressure measurement. When measuring, press to stop the measurement and
deflate the cuff.

(MENU button): Press this button to have the main menu pop up when the
interface is in the state of non-window setting.

(ON/OFF button): Press this button to control the startup and shutdown of the
monitor.

a.c. INDICATOR

Work INDICATOR

JOG-DIAL to select and change the settings. Operation can be performed by


JOG-DIAL
turning it clockwise, counterclockwise or pressing it down. JOG-DIAL is
mainly used in menu and window operation

1.3 Screen display


This monitor has a color LED screen, able to concurrently display collected patient parameters,
waveforms, and alarming information provided by the monitor, bed marks, clocks, monitor status and
other reminder information.
The main screen is divided into 4 sub-areas, i.e., Information Area , Waveform Area , Parameter
Area and Menu Area (As shown in Figure 0-2)

Information Area

Waveform
Parameter
Area
Area

Menu Area

-4-
Figure1-2Main screen display

Information Area ():


Prompt message in the information area appears and disappears together with the reported state. In
accordance with the content, it is divided into:
Network setup: Cursor stops in sign, press to enter system setup.

Network Bed No.: refer to IP address for monitor, The IP is 200.200.200.X,X is Network Bed
No.:, from 1 to 100

attention
Connection state of CMS (central monitoring system) : when displaying , no connection;
when displaying ,connection.

Network Bed No. should not conflict with other monitors, or there will be unnecessary problems
for the monitor.

If any problem happens because of confliction, unplug network wire, restart the monitor, reset the
Network Bed No. and connect the network wire again.
1. Patient Information: press to enter the Patient Information menu when cursor is in bed No., name
or patient group area.

PAT NO: can input four character.

Bed No.: Refer to the bed number of the patient being monitored, this area will be blank if
there is no input.

Name: Patient name, this area will be blank if there is no input.

Sex: Male and Female.

Patient Type: neonatal, pediatric, adult

Pacer: pacer state, pacer detected displaying , otherwise displaying

Height(cm): patients height

Weight(kg): patients weight

Blood A,B,O,AB,unkown

DEPT.(department): According to the department's name pop-up keypad input, support


English, spelling, handwriting input function.

Doctor : According to the department's name pop-up keypad input, support English, spelling,
handwriting input function.

Update patient : current patient information, it will be deleted if the update patient.

2. Time setup: set up local time

time: display system time


3. Technical alarm: display technical alarm, such as ECG lead off.

-5-
4. Physical alarm: display physical alarm, such as T2 too low.

5. Battery: display capacity of batter.

Full capacity
Not full capacity
Low capacity
Very low capacity, need to charge soon.
6. Volume setup: setup alarm volume, heart beat volume, key volume.

Alarm volume: there are five Alarm Vol levels, 1, 2, 3, 4 and OFF, where "OFF" level means
the alarm sound is closed.

Alarm volume on, alarm level 4


Alarm volume off
Beat volume: here are five Alarm Vol levels, 1, 2, 3, 4 and OFF.

Key volume: here are five Alarm Vol levels, 1, 2, 3, 4 and OFF

Touch sound: on, off. When open touch sound, click on the screen, will issue a point in the
sound of the screen, when close touch sound, no voice prompts

Attention
Visual alarm and alarm status
Alarm light winks or shines when there is an alarm. The colour of light means the alarm level. Refer
to alarm function chapter for details.

Waveform Area ()
There are four waveforms in the waveform area, which are respectively from up to down:
two-channel ECG waveform, SpO2 volume graphic waveform and respiratory waveform
(possibly from ECG module).
The name of selected waveform is displayed on the upper left part. For details, please refer to chapter
of ECG Monitoring. Each ECG waveform still shows the gain of this channel and the filtering method
of ECG waveform. A 1-mv rod is on the leftof ECG waveform.
When you choose/toucheach waveform, submenu of waveform will be pop up, which always occupies
most of space of waveform area, so that some waveforms are invisible. The original image will come
back after the menu exit.
Waveforms are refreshed at the set speed. For adjustment on waveform refresh speed, refer to the
chapter of each Parameter Setting.

Parameter Area()

Parameters can display at the fixed position (as shown in ~


12 of the following picture), which are

separately:

-6-


10
11

Figure 1-3 Main Screen



12

ECG
Heart Rate or Pulse Rate,unitbpm
pacer detection (PACE)
ST-segment of channel 1 and channel 2 (, unit: mv)
PVCs times ( Unit: times/minute)
NIBP
None-Invisive Blood Pressure
(From left to right) Systolic, Diastolic, Mean (, Unit: mmHg or kPa)

SpO2
SpO2,unit%
Pulse Rateunitbpm
IBP (optional)
Invisive Blood Pressure
(From left to right) Systolic, Diastolic, Mean (, Unit: mmHg or kPa)
TEMP
TEMP
Temperature,unit: or
CO2 (optional)
end-tidal CO2 (, Unit: mmHg or kPa)

inspiratory CO2 (
11 , Unit: mmHg or kPa)

-7-
Air Way Respiration Rate (AWRR)
12 ,unitbpm

RESP
Respiration Rate,unitbpm

The above monitored results will show in the parameter area.


The parameters are refreshed once per second, but NIBP value, once per measurement.
Users can select the monitoring parameters and the main screen will display the relative content.

Menu Area(
4)
1. PATIENT: patient information configuration. Refer to chapter of Patient Informatio for details.

2. ALARM SETUP: set up alarm type

ALARM RECORD TIME: in case of physiological alarm, the system can record the
information before and after the alarm time. The system can give three kinds of time, i.e., 8
seconds, 16 seconds. The seconds in the options are the sum of seconds before and after the
alarm time. For example, 8 seconds mean the information within 4 seconds before the alarm
time and within 4 seconds after such a time.

ALM PAUSE TIME (Alarm pause time):1 minute, 2 minutes or 3 minutes

ALAM LIMIT (Display alarm limits):ON andOFF

ALM LATER:disabled ,5s,10s,15s ,20s.

3. SURVEY SETUP: ECG, RESP, SpO2, NIBP and TEMP setup, refer to each chapter for details

4. SCREEN CHANGE: STANDARD, LIST FACE, TREND SCREEN, oxyCRG SCREEN, BIG
FONT.For details,please refer to chapters for each parameter.

5. NIBPSTARTt: press this button to start/stop NIBP measurement.

6. FREEZEN: the screen freezes when press this button, turn the knob to review all the waveform
stored for the last 4 minutes.

7. TREND GRAPH ,TREND TABLE, NIBP RECALL: refer to chapter 3 for details.

8. PRINT: press this button to record waveforms and patient information.

1.4 External Socket


Left Panel
Recorder is optional
Open the recorder door.
Take away the no-paper rod
Fix the new paper correctly, tip of paper out from the
head of printer.
3mmpaper must out of recorder door, close the door.
-8-
Press PRINT to check if the paper fixed well or not.
If no printing, prease re-fix the paper.
Figure1-4 recorder

Right Panel
On the right side of the monitor are sockets for each transducer
TEMP1
TEMP2
SPO2
ECG

NIBP
O2optional
CO2/AG(optional)

6
WAKE(optional)


8
7

Figure 1-5Right Side

This symbol means be careful; refer to this manual for details.

This symbol means this application part is of CF type, designed with special protection from
electric shock (especially provided with F-type floating insulation apparatus for permissible leakage
current) and suitable for the defibrillation process.
Other symbols will be introduced in the Patient Safety chapter.
this symbol means: BF type

means the equipotential grounding terminal.

A.C. indicator

work indicator

Power-up

Shutdown

Rear Panel
There are the following soclets in the rear panel:

-9-


11


10


6
7

1. Handle
H 2. Speaker
S 3.Labbel 4.Earthh line socket 5. AC poweer socket 66. Fuse holdeer 1
7. Fuuse holder 2 8.SD card socket
s 9. Neetworksockett10.Fan 1
11.Place for cclamp or hook
k

Warning
Thiss network porrt can only bee connected with
w CARL NOVELs
N centtral monitorinng system.

Warning
All the simulateed or digital equipments connected with w this monnitor must bbe certified under
u the
desiggnated IEC standards
s (succh as IEC 60950 Date Pro ocessing Equipment Standdard and IEC 60601-1
Meddical Equipm ment Standardd). And all coonfigurationss must comply with effecctive versions of IEC
606001-1-1 system m standards. Persons in charge
c of connnecting addiitional equipm ments with th
he input/
outpput signal term
minals shouldd configure thhe medical sy
ystem and bee responsible for complian nce of the
systeem to IEC 600601-1-1 stanndard. For anyy enquiries, please
p contactt the supplier..

A
Attention
Patiient cable interface, network
n intterface and other inteerfaces conn
nected to different
d
equiipments, the leakage currrent should not exceed th
he limit.

1.5 Built--in chargee battery


The multi-parameter monitor has a buuilt-in chargee battery. Whhen connectedd with AC po ower, the
he right side of the screeen, there is a , it
batteery will charrge automaticcally until it is full. On th
means charging state.
s Its yelloow part meanns the quantitty of the batttery. If this m
monitor has no
o built-in
batteery, the batterry state will display
d , it means no
n battery or defective
d batttery.

- 10 -
Chapter 2 Monitor Assembly
Attention
For normal work of the monitor, before use please read this chapter and the Patient
Safety chapter and assemble in accordance with the requirements.

2.1 Open Package and Check


Carefully pick up the monitor and accessories from the package box, and properly keep the package
materials for future transport or storage. Please check the accessories with the package checklist.

Check whether there is any mechanical damage;


Check all the exposed cables and plug in some accessories for test.
Any problems should be immediately raised to the Sales Department of our Company or our agents.

2.2 Connect with AC Cable


Procedures to connect with AC power cables:

Make sure the AC supply complies with the following specification: 100-250VAC50/60Hz
Use the power cables provided with the monitor together. Plug in the power cable into power supply
interface of the monitor, while insert the other end of this cable to a 3-phase earthing power socket.
Attention
Connect the power cable with the sockets special for hospital use.
If deemed necessary, connect with an equal-potential earthing cable. Refer to the
equal-potential earthing part in the Patient Safety chapter.
Attention
In case configured with a battery, the equipment after transport or storage must have the
battery taken for charging. Thus in case of direct booting without connection with AC
power supply, the equipment may not work properly due to insufficient power. With AC
power supply connected, the battery will be charged no matter the monitor is booted or
not.

2.3 Power on
The logo displays when the power is on, and appears the processing screen. After the 3~5 seconds
checking process, the system enters the monitoring main screen and the users can start operations.
Attention

- 11 -
In case of any fatal errors found during the self-detection process, the system will alarm.
Attention
Check all the available monitoring functions and make sure they work properly.
Attention
If a battery is configured, users must charge the battery after each time of use so as to ensure
sufficient power storage.
Attention
If any monitoring functions are found with damage or there are any error reminders, dont use
this monitor to monitor patients and quickly contact with the biomedical engineers of your
hospital or maintenance engineers of our Company
Attention
Reboot the equipment at least 1 minute after shut down.

2.4 Connect with Sensor


Connect the required sensor between the monitor and the monitoring position of a patient.

Attention
For correct connection methods and relevant requirements of various sensors, please refer
to Chapters 10-15.

2.5 Check Recorder


If there is recorder in monitor, check the paper. If there is no paper, see reference related in chapter 1.

- 12 -
Chapter 3 Syetem Menu
The monitor system setting is more flexible. Monitoring, waveform speed, volume and output, all can
be setup by user. Press the button or use turn-knob to choose main menu, popping up MAIN
MENU.

MAIN MENU including: PATIENT MANAGE, SURVEY SETUP, SELECTION, MONITOR SETUP,
FACE SELECT, TREND GRAPH, TREND TABLE, NIBP RECALL, ASPHYXIA STIMULATE
REVIEW, ALM RECALL ,WAVE RECALL ,INFO, DRUG CALC, MAINTAIN,DEMO.

3.1 PATIENT MANAGE


Attention
For deleting the patients current data, please refer to the NEW PATIENT in this
chapter.
Select the PATIENT MANAGE item under the system menu, and then pop up the following menu:

- 13 -
Figure 3-1 Patient Manage

Users can set the following content:


1. PAT NO can input four character
2. Bed NO.0-999 for option, for example, 666
3. Nameinput patient name to the popping up menu

Lock Shift Del Clr Enter

Caps Lock Caps shift delete clear enter


permanent one-off
4. SEXPatient gender( female, male)
5. PAT TYPEPATIENT TYPE(Neonate)
6. PACEPackmaker ON/OFF
7. Height(cm)0~300, for example, 180
8. Weight(kg)0~200, for example, 100
9. Blood A,B,O,AB,unkown
10. DEPT.(department): According to the department's name pop-up keypad input, support English,
spelling, handwriting input function.
11. Doctor : According to the department's name pop-up keypad input, support English, spelling,
handwriting input function.
12. Update patient : current patient information, it will be deleted if the update patient.

Attention
PACE: The default setting is OFF after you restart the monitor.

In this menu, user can select the UPDATE PATIENT and select CONFIRM TO UPDATE
PATIENT to update patient information.

Warning

- 14 -
Patient type changed, the alarm parameters such as heart beat and NBP may vary, usually
make sure the limits are suitable for the patient.

Pacer detection must be on for pacing patients. If falsely setting OFF, the monitor would
miktake pacing pulse as QRS, and not alarm for heatbeat stop

3.2 SURVEY SETUP


In the main menu, select SURVEY SETUP , Measurement settings include: ECG SETUP, SPO2
SETUP, NIBP SETUP, TEMP SETUP, RESP SETUP , CO2 SETUP (RESP SETUP and CO2 SETUP
both can appear only one of them), IBP <1,2>SETUP the parameters set in this menu parameters
chapters details in the description of this ignored the pop-up menu ,as shown below:

Figure3-2Survey Setup

3.3 SELECTION
Select the SELECTION SETUP in the MENU MENU and sub-menu following with Figure below,
including

Figure3-3Selection Setup
- 15 -
3.3.1 ALARM Volume

In the system there are five levels of Alarm Vol: OFF, 1~4.

"OFF" level means the alarm sound is closed.

WARINING

Where the alarm volume of the system is set at OFF, the monitor will not give alarm sound
in case of alarm, so you should use this function carefully.

3.3.2 HEART BEAT VOLUME

In the SYSTEM MENU select the SELECTION. Pitch on the BEAT VOL with the cursor and
turn the knob to select the volume from such five options as OFF, 1,23 and 4.

3.3.3 KEY VOL (Keyboard Vol )

Pitch on the KEY VOL with the cursor and select the volume from such five options as OFF,
1,23 and 4.

3.3.4 LCD Brightness (LCD LIGHT)

In the system there are five Brightness level, i.e. 1~5, where 5 means the maximum brightness.

3.4 MONITOR SETUP (Monitor Setting)


Select MONITOR SETUP in MAIN MENU, sub-menu following with figure below, including

Figure3-4 Monitor Setup

- 16 -
3.4.1 ALARM SETUP (Alarm Setting)

Alarm Setup has the following options:

ALM REC TIME (Alarm Record Time):

In case of physiological alarm, the system can record the information before and after the alarm time.
The system can give three kinds of time, i.e., 4 seconds, 8 seconds, 16 seconds. The seconds in the
options are the sum of seconds before and after the alarm time. For example, 8 seconds mean the
information within 4 seconds before the alarm time and within 4 seconds after such a time.

ALM PAUSE TIME (Alarm pause time)1 minute, 2 minutes or 3 minutes

ALM LIMIT (Display alarm limits)ON andOFF

ALM LATER:disabled ,5s,10s,15s ,20s

3.4.2 RECORD (Record output setting)

Options for record output:

REC WAVE1/ REC WAVE2: can not change

REC RATE: 25.0/50.0 mm/s, record speed

REC GRID: ON/OFF

RT REC TIME: 3S/5S/8S/CONTINUAL (real-time record time)

CONTINUAL means after pressing PRINT BUTTON , monitor will keep printing

parameters and waveform, until press to stop

Attention
The recorder is a component for option.
Attention
Where two similar waveforms are selected, the system will automatically adjust the other
one into a different one.

3.4.3 TIME SETUP (System Time Setting)

"TIME SETUP" with options below:


Setup year, month, day, hours, minutes and seconds.
Pitch on the content required for correction.

- 17 -
3.4.4 NURSE CALL SETUP

Options in nurse call setting:


Alarm on/off:on/off
Alarm level: high, middle, low

3.4.5 MODULE SETUP

Options in module setup:


ECG and SpO2 are not optional.
TEMP: ON/OFF. When it is ON, machinecan monitor TEMP, when it is OFF, machine can not
monitor TEMP, and no parameter area of TEMP in main interface.
RESP: ON/OFF. When it is ON, machinecan monitorRESP, when it is OFF, machine can not
monitor REST, and no parameter area of RESP in main interface.
NIBP: ON/OFF. When it is ON, machinecan monitor NIBP, when it is OFF, machine can not
monitor NIBP, and no parameter area of NIBP in main interface.
CO2(optional): ON/OFF. When it is ON, machinecan monitor CO2, when it is OFF, machine can
not monitor CO2, and no parameter area of CO2 in main interface
IBP(optional): ON/OFF. When it is ON, machinecan monitor IBP, when it is OFF, machine can
not monitor IBP, and no parameter area of IBP in main interface

3.5 WORK INTERFACE SELECTION


In the System Menu, select the FACE SELECT to enter the dialog box in the following Figure. Here
there are such six options as STANDARD, LIST FACE TREND SCREEN, oxyCRG
SCREEN , BIG FONT .

Figure3-5Work Interface
- 18 -
3.6 TREN
ND SCRE
EEN
Trennd gragh for the previous 1 hour can be
b diplayed in the resolution of one daata per one second
s or
one data per five seconds.

Trennd gragh for the previous 120 hour caan be diplayed


d in the resolution of onee data per miinute, per
five minutes or per ten minutees.
Userrs can selectt the TREND D Diagram Review
R item under the Syystem menu so as to po op up the
folloowing windoww:

Figure3-6Trrend Graph

Paraameter selectiion: HRRRRSPO2PR RTEMPN NIBPIBP1IBP2CO2INSAWRR.Y-axis R


means measurem ment value, X-axis
X means measuremeent time. is cursor for trend graaph, The
measurement vallues it points to display att the bottomee of the graphh, correspondding time at the
t upper
end of the graph: 2012-07-171123329.

Verttical axis is foor measured values


v and hoorizontal axiss for measureement time. TThe symb bol is the
cursor for TREN ND diagrams, and the meaasured value at a the positioon it arrows iss displayed below
b the
TREEND diagram m while its corrresponding time
t is display
yed above thee TREND diaagram.

3.7 TREN
ND TABL
LE
TRE
END Figure data over thee previous 120 hours can n be displayeed in the following resolutions: 1
minuute, 5 minutes, 10 minutess, 30 minutes and 60 minu
utes.

Seleect TREND Figure


F review
w under the system menu
u to pop up thhe following T
TREND Figu
ure:

- 19 -
Figure3-7Trend Table

Time corresponding to various groups of TREND data is displayed at the left column, with dates
braced. What are listed is the cases that have once been marked, which corresponds to the time of the
marked cases. Parameters in the TREND Figures can be categorized into the following 9 groups:
HR,
ST1, ST2
RR,
T1T2TD
SPO2, PR
NIBP S/D/MDATE
IBP1S/D/M
IBP2S/D/M
CO2 INS AWRR
NIBP TREND data has its own characteristics; besides of measured values, below each measurement
point there is time for this NIBP measurement.

3.8 NIBP RECALL


The monitor can display the latest 2000 NIBP measurement data in the NIBP review function. After
users select the NIBP Data Review item under the System menu, the windows will display the latest
10 NIBP measurement results and measurement time, as shown in the following:

- 20 -
Figure3-8NIBPRecall

Data is sorted in time sequence, from early to late, and each screen can display 10 times of
measurement data, while users can select Page up/ down to view later or earlier data. Maximally
2000 measurement results can be displayed, and when the measure times are over 2000, only the latest
2000 will be displayed.

3.9 ASPHYXIA STIMULATE REVIEW


In the MAIN MENU select the ASPHYXIA STIMULATE REVIEW to look through the version
information of the software and hardware.

Figure3-9 Asphyxia Stimulate Review

3.10 ALM RECALL(Alarm recall)

- 21 -
When parameter alarm occured ,the monitor would be memory the alarm parameter data. Enter the
MAIN MENU selected ALM RECALL could be recheck the patient status in RECALL
EVENT

Fig 3-10 Alarm Recall condition

Setup up the recall event from start time/date to end time/date


Would be re-check the alarm status in RECALL EVENT menu , the events include ALL ,
ECG ,SPO2 , NIBP , IBP , CO2 , RESP , TEMP status.
Optional ALM-RECALL_Condition window , would be recall the alarm parameter and waveform
following with figure below:

Fig 3-11 Recall event

3.11 WAVE RECALL


- 22 -
In MAIN MENU selected the WALL RECALLcould be recall the parts information or all
information within memory data , following with figure below.

Fig 3-12 Wave Recall-Condition

Setup the review types of the recall events and times , enter in WAVE RECALL-Condition selected
WAVE RECALL would be display the window , following with figure below:

Fig 3-13 Wave Recall

3.12 INFO (Monitoring Information)


In the MAIN MENU select the INFO to look through the version information of the software and
hardware.

- 23 -
Figure3-14 Monitoring
Information

3.13 DRUG CAL


The portable-type multi-parameter monitor can provide the computation for 15 kinds of medicines as
well as the Titration List Display Function, and output the content of Titration list on the recorder.

3.14 MAINTAIN
In the MAIN MENU select the MAINTAIN, submenu pop out:
Password: 5188
1. Wave type: SpO2 waveform and RESP waveform has two type to select: LINE and
FILL
2. VGA size:8.4TFT
3. Wave Mode: Color or not
4. Wave type:SPO2 wave ,RESP wave have two type , line and fill
5. Secreen Adjust: switch on touch screen as monitor indicated
6. Factory default :yes or no. Select Yes and you can save all configuration of the
current patient type as the users default setting. Select No and you can abandon the
current operation so that the system can continuously keep unchanged the original
setting.
Password: 2016
1. Language Selection
2. Filter Hz: OFF/ON

3.15 DEMO (Password: 5188)


In the System Menu select the Demo to have the Input Demo Password dialog box pop up.
Input the correct password and the system will enter the waveform demonstration state.
Demo Waveform means the simulated one set by the manufacturer for showing the monitor
performance and helping users with training.
In the practical clinical l use it is prohibited to use such a function because it will make the medical
personnel misthink they are the monitored patients waveforms and parameters so as to affect patient
monitoring and delay treatment. So this menu is set with the password.
- 24 -
3.16 SCR LOCK(screen lock)
Screen Lock: In order to avoid non-operators misuse Monitor, the instrument has a touch screen lock
function. Click on the "SCR LOCK" button to lock the touch screen in the main interface. For To
unlock the screen , continuous point lived SCR UNLOCK option for three seconds, you can unlock
the screen is locked.

- 25 -
Chapter 4 System Work Interface

4.1 Work Interface Selection


In the Main Menu, select the FACE SELECT to enter the dialog box in the following Figure. Here
there are such six interfaces to choose:
STANDARD, LIST FACE, TREND SCREEN, oxyCRG SCREEN, BIG FONT.

4.1.1 STANDARD

In the FACE SELECT menu, select the STANDARD to enter the standard work interface. The
Standard interface provides us the parameter waveforms under monitoring and displays the parameters
in the parameter area, as shown in the following picture:

Figure4-1 Standard Interface

4.1.2 LIST FACE

In the FACE SELECT menu, select the LIST FACE to enter the LIST FACE work interface.

- 26 -
Figure4-2List interface

4.1.3 TREND SCREEN

Enter the FACE SELECT and select the TREND SCREEN in the Work Interface Selection
menu to enter such an interface.

Figure4-3TrendSreen Interface

Location of trend diagrams

TREND diagrams is located at right side of waveforms, with the same colors to the corresponding

- 27 -
parameters.
TREND length

Dynamic trend length is 2 hours; in a trend diagram, the right side of the horizontal axis is 0 hour, and
the left side is 2 hours.
End of trend concurrence interface

Out of the Interface Selection options, select any other work interface to end the trend concurrence
interface.

4.1.4 OxyCRGSCREEN

In the Work Interface Selection menu, select the oxyCRG Screen to enter the oxyCRG work
interface.

Figure4-4OxyCRG Screen

TREND Diagram in oxyCRG Interface

OxyCRG Dynamic Interface is consist of compressed respiratory wave and RR.


OxyCRG Trend Length Selection

Two hot key at the below part of dynamic interface: TIME and TYPE

TREND Diagram for 1 minute and 2 minute can be selected through the trend time buttons.
Compressed Respiratory Wave and RR

The function of Respiratory Rate/Compressed Respiratory Wave means the operator can
select the PR Trend or Compressed Respiratory Wave as needed, under which the displayed
content occupies the same position. Select the PR Trend and this position will show the
TREND Diagram of the respiratory rate; select the Compressed Respiratory Wave and this

- 28 -
position will show the respiratory wave after compression.

In the Work Interface Selection menu, select other work interface to end the OxyCRG work interface.

4.1.5 BIGFONT INTERFACE

In the Work Interface Selection menu, select the BIGFONT to enter the big font interface.

Figure4-5Bif Font Interface

- 29 -
Chapter 5 Recording
In the Main Menu, select the MONITOR SETUP, then to RECORD menu

5.1 General Information on the Recorder


The recorder used with this monitor is a heat-sensitive array recorder, with print width of 50mm.
Recorder capability
Outputted waveforms run at25mm /sec. or 50mm / sec
Maximally record two waveforms
Grid output function is optional
English output
Real-time record time and waveforms are selected by users through menus
Automatic record interval is selected by users through menus, while waveforms are identical to
real-time records

5.2 Record Type


This monitor generates slip records of the following types:
Real-time continuous record;
Real-time 3, 5, 8-second record;
Automatic alarm record;
Frozen waveform record;

Start recording waveforms from the moment you press the button.

Real-time continuous record for 8-second defaulted by machine system (normally only for two
waveforms) or set by users through menu. Please refer to relevant chapters for details.

Attention
During output process, the next parameter alarming output will be outputted after completion
of the current output.

Frozen waveform record


In case waveforms are frozen, the system can output the designated waveforms on the screen and in
such a way record those unusual waveforms captured by freezing.
Remark record
Real-time record
Alarm parameter, alarming time, and FREEZE time
Bed number

- 30 -
Parameter name and value
Record time

Waveform name
Waveform amplitude (only for ECG waveforms)
ECG lead, ruler, and gain

5.3 Operation and Status Information of Recorder


Requirements on record paper
Only qualified heat-sensitive record paper can be used, otherwise there may be failure or quality
reduction in record, or damage to the heat-sensitive head.
Normal service
Do not pull out paper when the recorder is working.
Do not use recorder without record paper.
Insufficient paper

Dont boot the recorder when there is a reminder of add paper to the recorder in the information
area. Please load qualified heat-sensitive record paper.

Paper loading procedures

Open the recorder door;


Pull up the slide switch at the left rod of the recorder;
Load new paper exactly following the paper inlet, with the print side toward the heat-sensitive head;
Slightly pull the paper exposed from the other side, and align the paper properly;
Pull back the slide switch at the left rod of the recorder;
Remove the paper from the paper outlet of the recorder;
Close the recorder door.

Attention
Paper loading must be done softly so as to avoid heat on the heat sensitive head. Unless during
paper loading or trouble shooting, the recorder door must be kept open.

Solution to paper jam

When the running voice of the recorder sounds improper or paper outputs improperly, users should
open the recorder door to check whether there is paper jam. Procedures to clear paper jam:

Cut the recorder paper at the paper outlet side;


Pull up the slide switch at the left rod of the recorder;
Pull out the recorder paper from the bottom;
Re-load paper.

- 31 -
Chap
pter 6 Trend
d
It caan store 120 hours
h trend data,
d 2000NIB
BP and 60 alaarm events and support reecording. Observation
methhods are provvided in this chapter.
c

6.1 TREN
ND GRAP
PH (TREN
ND Diagrram)
TRE END diagram yed one dataa per second or one data per five
m for the lateest 1 hour caan be display
secoonds;

TRE
END diagram
m for latest120 hours can be
b displayed one data perr minute, perr 5 minutes, or
o per 10
minuutes.

Seleect TREND GRAPH


G in the
t MAIN MENU
M to po
op up the folloowing TREN
ND figure:

Figure6-1Trrend Graph

Verttical axis is foor measured values


v and hoorizontal axiss for measureement time. TThe symb bol is the
cursor for TREN ND diagrams, and the meaasured value at a the positioon it arrows iss displayed below
b the
TREEND diagram m while its corrresponding time
t is display
yed above thee TREND diaagram.

6.1.1 Selectt trend diaagrams foor variouss parameters to bee displayeed:

Use the cursor to t select the Parameter Selection


S opttion and revvise the displlayed conten
nts. Upon
display of the exppected param
meter, press thhe knob, then the TREND diagram for this parameteer will be
displayed in the window.
w

- 32 -
6.1.2 Selectt 1-hour or
o 120-hou
ur TREND diagram
ms:

Use the cursor to


t select the Resolution option,
o then select 1 secoonds or 5 secconds if you u want to
obseerve 1-hour TREND,
T or seelect 1 minutte, 5 minutes or 10 minutees if you wannt to observe 120-hour
TREEND.

6.1.3 Obserrve TREN


ND diagraams of latter or earllier durattion:

Presss the o
or buttonn or rotate thhe knob clock
kwise or anticclockwise so as to observe later or
earliier TREND curves.
c

6.1.4 Changge the dissplay zoom


m

Use the o the verticaal axis, while displayed size of the


or button too change dispplayed size of
TREEND curves will
w follow to change. Valuues higher than the biggesst axis value w
will be repressented by
the biggest
b axis value.
v

6.1.5 Obtaiin the TREND dataa at certa


ain time in
n the currrent TREN
ND

diagraam

Seleect Cursor and rotate thhe knob to coontrol movem ment of the cursor;
c with the cursor moves,
m its
arrowwed time allso changes, and the parrameter valu ue at such tiime will be displayed beelow the
horizzontal axis. If
I there is a indicatiion in the rig
ght side of thee window, w when the cursoor moves
ontoo this indicatioon the TREN
ND diagram will
w automaticcally page dow wn to displayy later TRENND curves;
and if there is a indicaation in the left
l side of thet window, when the cuursor moves onto this
indiccation the TRREND diagram m will autom
matically pagee up to displayy earlier TREEND curves.

6.1.6 Operaation sam


mple

Obseerve the NIBP TREND diiagram withinn the latest 1 hour:


h
Press the TREND
T buttoon on the conttrol panel to pop
p up the Main
M menu;
Select the TREND
T Diaggram Review w option in thee menu;
1. Select thhe parameterr: rotate the knob
k in the Paarameter Seleection item uuntil NIBP is shown
in the drropdown boxx;

2. Select 1 or 5 secondss in the Resollution item;

3. Press thhe or button or


o rotate the knob,
k while observing
o chhanges in the TREND
diagram
m time and TR
REND curvess;

4. Stop at the period too be carefullyy observed; in


n case the verrtical axis is oout of properr size, for
examplee, some TRE END values exceed
e the hiighest value of the currennt vertical ax xis, select

- 33 -
Adjust amplitude to adjust;

5. If users want to know the measured value at certain time, just select move cursor and move
the cursor to where they wants, then time will be displayed above the curve and measured
values below the curve;

6. If users need output the TREND diagrams to the recorder, just select the record button so
as to let the recorder output NIBP TREND of the current review window;

7. Press to exit observation on TREND diagram.

6.2 TREND TABLE (TREND Figure)


TREND Figure data over the previous 120 hours can be displayed in the following resolutions: 1
minute, 5 minutes, 10 minutes, 30 minutes and 60 minutes.

Select TREND TABLE under the Main Menu to pop up the following TREND figure:

Figure 6-2Trend Table

Time corresponding to various groups of TREND data is displayed at the left column, with dates
braced. What are listed is the cases that have once been marked, which corresponds to the time of the
marked cases. Parameters in the TREND Figures can be categorized into the following 9 groups:
HR,
ST1, ST2
RR,
T1T2TD
SPO2, PR
NIBP S/M/DDATE
IBP1S/M/D
IBP2S/M/D
CO2, INS, AWRR

- 34 -
NIBP TREND data has its own characteristics; besides of measured values, below each
measurement point there is time for this NIBP measurement.

6.2.1 Select TREND Figures in various resolutions

Use the cursor to select a resolution and use the knob to change options so as to change the time
interval for TREND data.

6.2.2 Observe earlier or later TREND curves

Press or button or rotate the knob clockwise or anticlockwise so as to observe later or earlier
TREND curves.

6.2.3 Observe TREND data of various parameters

Press or button and select one group of parameters out of 6 available groups.

6.2.4 Operation sample

To observe a NIBP TREND Figure:


Press the TREND button on the control panel to pop up the Main menu;
Select the TREND Figure Review option in the menu;

1. Press or button or rotate the knob to select the NIBP S/M/DDATE;

2. Select the resolution: click the left item and select the expected data interval;

3. Press or button or rotate the knob, while observing NIBP TREND data over various
time;

4. Press to exit observation on TREND table.

6.3 NIBP RECALL


The monitor can record the latest 2000 NIBP datas. After select the NIBP RECALL in MAIN MENU,
the window will display 10 groups of NIBP records as follows:

- 35 -
Figure 6-3 NIBPRECALL

Data is sorted in time sequence, from early to late, and each screen can display 10 times of
measurement data, while users can Press or button to view later or earlier data. Maximally
2000 measurement results can be displayed, and when the measure times are over 2000, only the latest
2000 will be displayed.

- 36 -
Chapter 7 Drug Calculation & Titration List
The portable-type multi-parameter monitor can provide the computation for 15 kinds of medicines as
well as the Titration List Display Function, and output the content of Titration list on the recorder.

7.1 DRUG CALC


Medicines able to be calculated under this system are: aminophylline, dobutamine, dopamine,
epinephrine, heparin, isuprel, lidocaine, nipride, nitroglycerin and pitocin. Besides, there are Drag A,
Drag B, Drag C, Drag D and Drag E provided to flexibly replace any medicine.
Users can select Drug Calculation under the MAIN MENU to pop up the following window:

Figure7-1DrugCalculation

The following formulae are used for medicine dosage calculation:


Medicine contents = Total medicine volume / Liquid volume
Infusion speed = Medicine dosage / Medicine contents
Continued time = Total medicine volume / Medicine dosage
Medicine dosage = Infusion speed Medicine contents

7.1.1 Operation method:

In the medicine calculation window, operators should firstly select names of the medicines to be
calculated, and then confirm patient weight, and input other known values. Subsequently, operators
move the cursor to the various calculation items in the calculation formulae, press the knob and rotate
it, so as to select the calculation value. After the calculation value is selected, value of the items to be
calculated will be displayed at the corresponding position. Values for each calculation item have their
- 37 -
limits, if the calculated results exceed such limits, the system will display ---.--.

Attention
Under this medicine calculation function, other menu items are available for input only
after operators input patient weight and medicine names. The values firstly given in the
system are only a random group of initial values, and operators should not take such
values as calculation standard, instead, should re-input a group of values suitable for the
current patient, based on the comments by doctors.
Attention
Each kind of medicine is subject with fixed units or unit series, and operators must select
proper unit based on comments by doctors. Under the same unit series, numbering system
of the units will be automatically adjusted with the current input values, and when the
input value exceed out of expression of the relevant unit, the system will display ---.
Attention
After operators input a certain value, the system will give a clear reminder in the menu,
reminding operators to check correctness of the inputted value; only inputted values are
guaranteed to be correct, the calculated values will be reliable and safe.
Attention
In case of newborns, dropping speed and volume of an infusion drop make no sense.
Attention
The system gives a reminder for each inputted value, asking operators to confirm. Operators
must be serious with every such reminder, as only valid and correct inputs can get reliable
calculation results.
Select medicine type: move the cursor onto Medicine name, rotate the knob and select one from
aminophylline, dobutamine, dopamine, epinephrine, heparin, isuprel, lidocaine, nipride, nitroglycerin,
pitocin, Medicine A, Medicine B, Medicine C, Medicine D and Medicine E, altogether 15 types. At
one time, only one type of medicine can be selected for calculation.
Attention
The above introduced A, B, C, D, and E are not actual medicine names but only codes for
medicines. Units for these five types of medicines are fixed, and operators can select proper units
based on general practice of medicines. The expression rules of their units are as follows:
Medicines A, B, and C are fixed under the mg unit series, including g, mg, and mcg; Medicine D is
fixed under the unit unit series, including unit, k unit, and m unit; and Medicine E is fixed under the
mEq unit.
Patient weight: When entering the medicine calculation window, operators should firstly or secondly
input patient weight, which will be taken as independent information for calculation of medicine
contents.
Attention
This function of medicine calculation is only to provide a medicine calculator, while values in the
list should not be related with the patient under monitoring. Thus the patient weight under this
menu is different from the patient weight in the system; when the system refresh with a new
patient, values in this menu will not be affected.

- 38 -
7.2 TITRATION

7.2.1 Enter the Titration list:

In the Drug Calculation menu, pitch on the Titration to enter the Titration list interface.

The Titration list interface for medicines is shown in the following Figure:

Figure7-2 Titration List

The specific operations are as follows:

In the Titration list, move the cursor to the Reference Item with the knob first, and then press the
knob to select the required item. Dosage and Injection Speed are two options.

Move the cursor to the Step Length and press the knob to select the step length in the range of 1~10.

Move the cursor to the Dosage Type and press the knob to select the dosage unit.

Move the cursor to the or button and press and turn the knob to check the previous and next
pages of the list.

Move the cursor to theRecord and press the knob to output the Titration list data on the current
display interface.
Move the cursor to the and press the knob to return to the Medicine Calculation menu.

- 39 -
Chapter 8 Pattient Safety
S
The portable monitor
m is deesigned to meet
m the intternational safety
s requirrements IEC C60601-1,
EN660601-2-27 and a EN606011-2-30 formuulated for meedical electricc equipmentss. Its furnish hed with
floatting inputtedd defibrillation resistance and surgery electric kniffe protection.. If correct electrodes
(refeerring to the ECG and RESPR chapterss) are installed followingg supervision of the manu ufacturer,
screeen display wiill be recoverred within 10 seconds afterr defibrillatioon.

Thiss symbol meaans the appliication part is i of IEC 600601-1 type CF


C equipmennt, and designed with
speccial electric shock resistannt apparatus (especially
( with
w an F-type floating inssulation appaaratus for
perm
missible leakaage current), especially
e reccommended for
f use duringg defibrillatioon period.

Warn
ning
Durring defibrillation period
d dont touch
h the relevantt patients, beeds or equipments.

Envvironmen
nt
Userrs should follow the folloowing guides to ensure ab bsolute safetyy of electricitty installation
n. For an
enviironment wheere the portaable monitor is located, usersu should reasonably
r aavoid vibratio on, dusts,
corroosive or expllosive gases, extreme tem mperature and moisture. In I case installled inside a chamber,
c
the front
f side muust be given sufficient
s spacce for conven nient operatioons, and whille the chambeer door is
openn, the rear sidde must be giiven sufficiennt space for easy repair. Besides, must make sure off air flow
insidde the chamber.

The monitor, whhen working in an ambiennt temperaturre between 040, caan meet the technical
indeexes, otherwise may havee equipment accuracy affe fected or partts or circuits damaged. Moreover,
M
a least 2 inch (5 cm) of space reserved surrounding the monitor tto ensure air flow.
theree should be at f

Pow
wer Sourcce
Pleaase refer to the Product Sp
pecification chapter.
c

Moonitor earrthing
To protect
p patiennts and mediical staffs, thhe portable monitor
m must has its coveer connected with the
earthh; for such reason
r the monitor
m is equuipped with a dismountabble 3-line cabble, which should be
pluggged into a matching
m 3-linne socket and further conn
nected with thhe earth throuugh the groun nd line of
the power
p supplyy cable. In caase of no 3-liine socket, pllease consultt with the eleectricity staffs
fs of your
hosppital.

Warning
- 40 -
Don he 3-line cable of this moonitor with a 2-line sockeet.
nt connect th

Connnect the grouund line with the equal-pootential earthin


ng terminal of
o the monitoor. If unawaree whether
a ceertain equipm
ment combination is risky in terms of equipment
e sppecification, for example,, whether
gathhered leakage current is daangerous, users should connsult with relevant manufaacturers or sp
pecialists,
so ass to make surre the necessaary safety of the
t relevant equipment
e wiill not be dam
maged by the proposed
p
com
mbination.

Equal-poten
ntial earth
hing

Firstt level protecction on the equipment hash been conttained in the house protective earthing system
throuugh earthing of the powerr socket. For heart or head d internal cheeck, this porttable monitorr must be
indivvidually connnected with an
a equal-poteential earthing g system. Onne side of the equal-potenttial cable
(poteential balanced cable) shoould be connnected with th he equal-poteential earthingg terminal onn the rear
paneel of the monnitor, while thhe other side connected with
w one interfface of the eqqual-potentiaal system.
In caase of any daamage to the protective eaarthing system m, the equal-ppotential eartthing system will take
the safety
s functioon of protectiing the earthiing cable. Heeart or head checks
c shouldd be conducteed within
housses for medical use instaalled with protective earth hing systemss. Before eacch time of use,
u users
shouuld check whether the equuipment is undder good worrk status and pay attentionn the cable co onnecting
patieents and the equipment
e muust be free froom electrolyttes pollution.

Warning
If th
he protectivee earthing syystem is instaable, the mo
onitor should
d be applied with interna
al power
suppply.

Condensatioon

Duriing work perriod the equipment must be made surre of no conddensation. W


When the equiipment is
shiftted from one room to anoother room, coondensation may
m be form
med as the equuipment is ex
xposed in
moisstured atmospphere and diffferent temperrature.

Warning
If th
he monitor iss used wheree there are flaammable an
nesthetic agen
nts, there maay be explosiion.
Expllanations on Symbols Useed in the Monnitor
See reference in external
e interrface in chaptter 1.

- 41 -
Chap
pter 9 ECG
G Monitoringg

9.1 Definiition of ECG


E Moniitoring
ECGG monitoring describes coontinuous waaveforms of cardiac
c activitties of patiennts so as to accurately
assess the current psychologiccal status of the
t patients. Thus
T proper connection
c off ECG cabless must be
ensuured in order to obtain corrrect measurem
ment values. This portablee monitor conncurrently can n display
2 waaveforms undder normal woork status.

A paatient cable consists of twoo parts:


Wire connecting the moonitor;
Leads connnecting patiennts
With a 3-leead facility for
fo monitoringg, ECG can obtain
o two waaveforms from
m two differeent leads.
Users can use the knobb, in the left side
s of the EC
CG waveformms on the scrreen, to directly select
the lead to be monitoredd.
Displayed monitoring parameters
p incclude HR, STT segment meeasurement value and arrhhythmia.
All the aboove parameterrs can be takeen as alarm parameters.
p
Attentionn
In the ex-ffactory settin
ng of the moonitor the EC
CG waveforrm displays aat the positio
on of the
first two waveforms
w in
n the waveforrm area.

9.2 Attentions durring ECG Monitoriing

Warn
ning
Don
nt touch patiients, tables or the equip
pment during
g defibrillation.

Warning
The ECG cable used for EC
CG signal monitoring by
y this portab
ble monitor m
must be prov
vided by
our Company.

Warning
Wheen connectin ng electrodess or patient cables, userrs should enssure there iss no connecttion with
otheer electric conductive
c p
parts or thee ground, an nd more immportantly, eensure all th he ECG
electtrodes includding neutrall electrodes are
a attached with patientt bodies instead of touch hing with
electtric conductiive parts or the ground.
Atteention
Distturbance froom non-earth hing equipm
ments around d a patient or ESU distturbance maay affect
wavveforms to fuunction improperly.
Wheere this moonitor is opeerated accorrding to thee conditionss specified iin the EN60601-1-2
(antti-radiation ability:
a 3V/M
M) and the electric-field
e d strength ab
bove 1V/M m may give risse to the
- 42 -
meaasurement mistakes
m undder variouss frequenciees, it is sugggested thatt the electroradiant
equiipment should not be useed in the placce next to the ECG/Resp
pirometer.

9.3 Monittoring Proocedures

9.3.1 Prepaaration

Takee patient skinn preparation before installlation of electrodes:


Skinn is bad condductor, thus too ensure goood touch betw ween electroddes and skin its very imp
portant to
welll prepare patieent skin.
Wheen necessary, remove bodyy hair surrounnding the elecctrode positioons.
Cleaan thoroughlyy the skin with soap and water (dont use ethyl ether e or pure alcohol, as they
t will
increease skin resiistance)
Drilyy sweep the skin
s so as to increase
i capilllary blood flow as remove skin scraps and oil.
Instaall spring clam
mp or snap beefore installaation of electrrodes
Put the electrodes on patiennt body; in case c the elecctrodes contaain no conduuctive paste, coat the
condductive paste before installation.
Connfirm power suupply.

Warning
Dailly check wh
hether the ECG
E electroode plates sttimulate skiin; in case of any sensitiveness
phennomenon, ch
hange the eleectrodes or positions
p everry 24 hours.
Atteention
To protect
p the environment,, used electroode must be recycled or properly
p treated.

Warning
Befoore monitoriing check wh hether the leaads work properly. Afterr users plug out the ECG G cables,
screeen will displlay the errorr informationn of Sensor disconnectedd and activvate voice ala
arming.

9.3.2 Installl ECG leaads

Atttention
The following table
t lists th
he lead nam
mes under th
he Europeann and US sstandards (leeads are
reprresented in R,
R L, N, F annd C under the Europea
an standard and in RA, LA, RL, LLL, and V
under the US staandard)
US standardd Eu
uropean standdard

Lead name C
Color Lead name Color

RA W
White R Red

LA B
Black L Yelloow

- 43 -
LL Red F Green

RL Green N Black

V Brown C White

Three-lead ECG electrodes position (Figure 9-1):

Five-lead ECG electrodes position(Figure 9-2):

Speical 3-leads ECG for neonate monitoring

- 44 -
Attention
For patient safety, all the leads must be connected with patient body.
For 5-lead device, put the breast (V) electrode at one of the following positions:
V1, around the 4th frame at right side to the breast bone
V2, around the 4th frame at left side to the breast bone
V3, between V2 and V4
V4, around the 5th frame along middle line of the left clavicle
V5, at front line of the left axilla, at the same horizontal position of V4
V6, at middle line of the left axilla, at the same horizontal position of V4
V3R-V7R, at right side of the breast, identical to those positions at left side
VE, at apophysis of the xiphoid process; in case V leads are put on the back, the electrodes must be
put at one of the following position:
V7, around the 5th frame at back line of the left axilla on the back
V7R, around the 5th frame at back line of the right axilla on the back

Figure9-35-lead Chest Electrode Position

- 45 -
9.3.3 ECG lead conn
nection reecommend
ded for su
urgery paatients

Warning
Wheen using ES equipments,, users shoulld put ECG electrodes
e att middle of tthe ES earthiing plate
and ES knives tot prevent frrom burns. Cables
C S equipmentss can not be wrapped with ECG
of ES
cablles together.

Posiitioning of EC u to operatioon types, for example, for chest operatiion, electrodees can be
CG leads is up
o breast sidees or back. Innside operatioon rooms usiing surgery ellectric knivess, sometimes artificial
put on
discrrepancy mayy affect ECG G waveforms; to reduce suchs artificiaal discrepancyy, users may
y put the
electtrodes at the left and righht shoulders, near left and
d right abdom men, with breeast lead at leeft to the
N electrodes should be puut on left arm
midddle breast. No m; otherwise the ECG waaveforms willl be very
smalll.

Warning
Durring use of ES
E equipmen nts, dont putt electrodes near the earrthing plate of such equipments,
otheerwise ECG signals will be
b much distturbed.

9.4 ECG Hot Key


Figgure9-4 ECGH
HotKey

me of the Firstt ECG Lead


Nam 1 :

ECG
G using 5-leadd, the selectabble leads incllude I, II, III, aVR, aVL, aVF
a and V;
ECG
G using 3-leadd, the selectabble leads incllude I, II and III. (For neonnate)
- 46 -
The leads on the ECG waveform should not have the same name, otherwise the system will
automatically change the similar name into another.

The 1st-ECG Waveform Gain


2 : used to adjust the amplitude of ECG waveform.

The gain of each calculation channel can be selected, which has such columns as 0.25, 0.5, 1 and
2 as well as auto mode. Auto mode means that the monitor can automatically adjust the gain. On the
right side of each ECG waveform there is a 1-mv rod of which height and amplitude are proportional.

Attention
The input signal being too strong, the wave crest may be truncated. At this time users can manually
change the gain column of ECG waveform by reference to the actual waveform for fear of
incompleteness of waveform.

Filtering Mode
3 : The cleaner or precise waveform can be obtained through filtering.

There are three filtering modes for option. The unfiltered ECG waveform is shown in the diagnostic
mode; the monitoring mode will possibly lead to the artifact filtering; the operation mode used in the
surgery can reduce the artifact and interference from the electrosurgery unit. The filtering mode can be
used in two channels and displayed on the upper part of the first ECG waveform.

Warning

Only in the diagnostic mode can the system provide the real signal that has not been treated. In
the filtering modes such as Monitoring and Operation, the ECG waveform will abnormally
occur to the different extents. At this time the system can only provide the basic ECG status, and
will produce greater influence on the analysis result of ST Segment. The analysis result of ARR
may partially be affected in the operating mode, so it is suggested that efforts are made to
monitor patients in the diagnostic mode when the interference is small.

The Name of 2nd-ECG Waveform Gain: for details, please refer to


1

Attention
The detected pacing signal displays on the upper part of the ECG waveform in the waveform area,
which is expressed as .

9.5 ECG Menu

9.5.1 ECG setting menu

Use turn knob and move cursor on the main screen to the ECG hot keys in the parameter area, then
press the knob to pop up the ECG Setting menu:

- 47 -
Figure9-5ECGSetup

Alarm: Select ON to give alarm prompt and storage when the heart rate alarm happens.
will be prompted beside ECG.

Alarm level: three options: High, MED and Low, and high is for the most serious alarm.

Alarm record: Users can select On to print HR alarms when they happen

ST ALM ON/OFF: Select "ONin the event of ST1 or ST1 overrun alarm prompt and storage,

select the "OFFs not an alarm, and ST1 next have" pompt.

PVCs ALM ON/OFF: Select "ONin the event of PVCs or PVCs overrun alarm prompt and

storage, select the "OFFs not an alarm, and PVCs next have" pompt.

HR ALM SETUP: setup heart rate hight limit ,middle limit ,low limit of the upper and lower
limits .

Alarms will happen once the HR values exceed the upper or lower limit.
Adjustable ranges for HR alarm upper & lower limits are as follows:
Adjustment step
Highest upper limit Lowest lower limit
length
HR newborn 350 15 1
Attention
Users should set the alarm upper & lower limits based on the clinical conditions of every patient.
Setting of the HR alarm upper limit is very important, and users should not set it too high but
consider fluctuation factors. The set HR alarm upper limit should not be over 20 beats/ minutes
than patient HR.

9.5.2 ECG setting in waveform area

Turn the knob to waveform area,press the knob to enter ECG waveform setting

- 48 -
Figure9-6 ECGSetup
Lead Name

ECG using 5-lead, the selectable leads include I, II, III, aVR, aVL, aVF and V;

ECG using 3-lead, the selectable leads include I, II and III.

Gain: used to adjust the amplitude of ECG waveform. The gain of each calculation channel can
be selected, which has such columns as 0.25, 0.5, 1 and 2 as well as auto mode. Auto mode
means that the monitor can automatically adjust the gain. On the right side of each ECG
waveform there is a 1-mv rod of which height and amplitude are proportional.

Sweep:ECG Waveform scanning wave has four levels for option, such as 6.25, 12.5, 25.0 and
50.0mm/s.

Filtering Mode: The cleaner or precise waveform can be obtained through filtering. There are
three filtering modes for option. The unfiltered ECG waveform is shown in the diagnostic mode;
the monitoring mode will possibly lead to the artifact filtering; the operation mode used in the
surgery can reduce the artifact and interference from the electrosurgery unit. The filtering mode
can be used in two channels and displayed on the upper part of the first ECG waveform.

Wave Color: green, cyan, red, yellow, white, blue, violet.

- 49 -
9.5.3 ECG setting in measurements

Figure9-7ECGSetting menu

ALM ON/OFF:on or off When the heart rate alarm happens. Select OFF will be
prompted beside ECG.

Alarm record: Users can select On to print HR alarms when they happen

Lead type: 5-lead or 3-lead

HR channel

Channel 1 means the HR is calculated according to the first ECG waveform data.

Channel 2 means the HR is calculated according to the second ECG waveform data.

Auto means the monitor will automatically select the channel of calculating HR.

HR From

Users can select to check HR through ECG or PLETH (blood-oxygen volume recording
waveform); if users select Automatic, the monitor will decide HR source based on signal
quality; if users select All, the monitor will concurrently display HR and PR. In case PLETH is
taken as the HR source, the PULSE reminder will be displayed together with pulse voice.

In case PLETH is taken as HR source, no alarm judgment on HR but alarm judgment on PR will
be conducted. In case All is selected, PR measurement values will be displayed in the right to
SpO2 on the main screen, and HR & PR make alarms at the same time. Pulse voice will give
priority to HR, as long as there is HR data, voice reminder will be there; only when there is no
HR data, voice reminder will be subject with PR.

FILTER,SWEEP ,WAVE COLOR : See this chapter ECG Settingsparameter area


corresponding

NOTCH: When set to ON, it is a method of inhibiting the method and apparatus of the power
frequency common mode interference, for bioelectric signals measurement system including a
- 50 -
common mode interference signal extraction circuit and a drive circuit connected to the circuit;
particular, the apparatus furtherincludes a phase compensation processing means for receiving
from the subject organisms of biological signals and the driver circuit to provide the amplified
signal, the output is sent to a feedback signal by measuring biometric.

HR ALM SETUP: setup heart rate hight limit ,middle limit ,low limit of the upper and lower
limits .

ST AMALYSIS : ST Segment Analysis Select this item and enter the ST Segment Analysis
menu.

ARR ANALYSIS:ARR Analysis Select this item and enter the Arrhythmia Analysis menu.

ECG CAL : When the ECG calibration, you can not monitor the patient. Tip: in the middle of the
screen of the instrument calibration can not monitor the patient.Stop the calibration is required to
return to the ECG Setup select to stop ECG calibrationmenus.

DEFAULT : Select "default configuration" dialog box, the user can choose "No" or Yes" to be
the default configurationororiginal configuration will be set

About ST Monitoring
The monitor performs ST segment analysis on normal and atrially paced beats and calculates ST
segment elevations and depressions. This information can be displayed in the form of ST numerics
and snippets on the monitor.
All available leads can be monitored continuously. The ECG waveform does not need to be displayed
on the Screen for ST segment analysis.

Warning

This monitor provides ST level change information; the clinical significance of the ST level
changeinformation should be determined by a physician.

ST Segment Analysis Menu


ST Analysis: this switch is mainly used to set the state of ST Segment Analysis. Only when the switch
is ON, ST Segment Analysis can proceed.
Alarm on/off: Where ON is selected, the alarm prompt and saving will proceed when ST analysis

result is alarmed; where OFF is selected, alarming will not happen, but will be prompted
beside ST in the screen parameter area. ST Alarm will be triggered only when its measured value
exceeds ST Alarm Upper Limit or ST Alarm Lower Limit.
Alarm Level: used to set the ST Alarm Level according to three options such as High, Middle and
Low.
Alarm Record: when it is set at ON, the system will start the recorder for alarm record.
ST alarm setup: setup ST alarm hight limit ,middle limit ,low limit of the upper and lower limits
The adjustable range for upper limit and lower limit of alarm as follows:

Max. Upper Limit Min. Lower Limit Single Adjustable Quantity


ST 2.0mv -2.0mv 0.1mv
DEF POINT (Determine the ST Segment AP (Analysis Point)): Select this option to enter the
- 51 -
Determine the ST Segment AP window and set the values at ISO and ST.

ISO (BP: base point): set the baseline point. Power on time is ste at 78 ms.
ST (SP: starting point): set the measuring point. Power on time is set at 109ms.

Figure10-8 Determine the ST Segment AP


ISO and ST are two measuring points of ST Segment, which are adjustable.
R wave crest point is the reference point in setting of ST measuring point (as shown in the following
figure):

R Wave

P T

} ST Value
BP: ISO Q }
S
-78 ms ST Measuring Point
Initial Value +109 ms
+109 ms

Figure10-9 ST Analysis Point


ST measured value of each HB composite waveform is the vertical distance between this waveform
and the crossing of two measuring points.

Caution
Where obvious changes happen to the patients HR or ECG Waveform, it is necessary to adjust
the ST measuring point in the following methods.
Method of Adjusting ISO and ST
Adjust the values by turning the knob.
Setting the measuring point of ST Segment, please open the Determine Analysis Point window and
the window will show QRS wave-group module (if the channel is not opened, ST Analysis Switch
OFF will be prompted). The location for high-brightness line in the window can be adjusted. Select
the ISO or ST first, and then turn the knob both leftward and rightward to move such a line in parallel

- 52 -
so as to determine the reference point or measuring point.

Caution
The abnormal QRS wave group will not be taken into consideration when ST segment is
analyzed.
Alarms & Reminders used in ST Segment Analysis.

Caution
The alarm limits for two measured values of ST SEGMENT are coincident. The alarm limit of
each channel cant be set alone.
The alarm record switch in the related menu being opened, the physical alarm caused by the parameter
alarm super-limit will make the recorder automatically output the alarm parameter values and related
measured waveforms.
For the physical alarm, technical alarm and noticed information possible to happen in the ST Segment
Measurement, please see the following table.
Physical alarms:
Prompt Causes Alarm Levels
Messages
ST1 too The measured value for ST Segment of Channel 1 is higher than the Selectable by
high set alarm upper limit. users
ST1 too low The measured value for ST Segment of Channel 1 is lower than the Selectable by
set alarm lower limit. users
ST2 too The measured value for ST Segment of Channel 2 is higher than the Selectable by
high set alarm upper limit. users
ST2 too low The measured value for ST Segment of Channel 2 is lower than the Selectable by
set alarm lower limit. users
Technical alarms
Prompt Alarm
Causes Solutions
Message Level
ST Alarm
Function Stop use of ST SEGMENT alarm and advise the
Limit is High
safety failure biomedicine engineer or our companys servicemen.
wrong.
Prompt Message (including general alarm message):
Prompt Alarm
Causes
Messages Level
ST1 measurement The measured value for ST Segment of Channel 1 exceeds the measured
High
out of scope range.
ST2 measurement The measured value for ST Segment of Channel 2 exceeds the measured
High
out of scope range.

Arrhythmia Analysis
Press SURVEY in main interface, one submenu pop up; choose ECG SETUP, Arrhythmia analysis
information inside.

Arrhythmia analysis is used in clinically monitoring the ECG of patients, detecting the HR change and
PVB, saving the arrhythmia events and producing alarm messages. Besides, it can be used to monitor
the patients with or without the pacemaker. The qualified personnel can evaluate the patients status
(such as HR, PVCS (PVB), frequency, rhythm and abnormal HB) according to arrhythmia analysis

- 53 -
and make a diagnosis and give treatment. In addition to detect the ECG change, arrhythmia analysis
can monitor patients and give a suitable alarm.

The default of arrhythmia monitoring function is off. Users can start this function as needed.

Arrhythmia monitoring can arouse the doctors attention to the patients cardiac rhythm and give an
alarm through test and classification of arrhythmia and HB abnormality.

This monitor can support 13 kinds of arrhythmia analysis.

In arrhythmia analysis, the system will save the latest 60 alarm events (the single-channel ECG
waveform four seconds before and after alarm). The operator can edit the arrhythmia events through
this menu.

Arrhythmia Analysis
In the ECG SETUP menu, select the Arrhythmia Analysis to enter the following submenu
ARR ANAL(Arrhythmia Analysis): During monitoring it can be set at ON and during default,
OFF
Alarm on/off: Select the ON and the alarm prompt and saving will proceed; select the OFF

and PVCs alarm wont start, but prompting do beside PVCs in the screen parameter area.

Alarm Level: There are such three options as high, middle and low. High means the
most serious PVCs alarm.

Alarm Record: Select the ON and the recorder will output during PVCs alarm.

Alarm Upper Limit: PVCs alarm is based upon the set alarm upper limit. The alarm will happen
when PVCs exceeds the upper limit.

ARR ALARM(ARR alarm setup):

ARR TYPE :ASYSRTOLEVFIB/VTACR ON TVT>2COUPLETPVCBIGEMINY


TRIGEMINYTACHYBRADYPNCPNPMISSED BEATSARRHYTHMIALEARNING
NOIS SIGNAL SIGNAL WEAK.

ALM ON/OFF :ON ,OFF

ALM LEV :HIGH ,MED, LOW

ALM REC :ON/OFF

ARR ALM QUICK SETUP :The alarm fully open, the alarm fully closed, the record fully
open, to record fully closed, the alarm level. The user can select the alarm fully open
various arrhythmia alarm is set to "On", select "Alarm full off various arrhythmia alarm set
to" Off ". Similarly, the record fully open "alarm record switch can be all set to" On ", the
The record fully closed alarm record switch can be all set to" Off ".

ARR RECALL(Arrhythmia Recall): Select this option and you can view and edit the
patients arrhythmia information.
- 54 -
The latest saved arrhythmia events are listed in the window (one page can show 10 events and at most
6 pages can display).

Press or to observe the list of arrhythmia events in other pages.

Cursor Movement: to move the cursor to select the arrhythmia events in the list.

Figure9-8Arrhythmia EventsReview

Figure9-9 Arrhythmia Waveform Review


Attention
In the event that the number of arrhythmia event is more than 200, the monitor will retain the
latest instead of the earliest. As for the monitor with the power-fail saving function, it can save
200 arrhythmia events with power-fail.

PVCs Alarm Message and Prompt Message:


When the alarm record switch in the related menu is turned on, the physical alarm arising out of that
the parameters exceeds the alarm limit will make the recorder automatically output the alarm
parameter values and related waveforms.

The physical alarm and technical alarm that may happen in PVCs parameter measurement are listed in
- 55 -
the following table.
Physical alarms:
Prompt Causes Alarm Level
Message
PVCs too high PVCs measured value is above the set alarm upper limit. Selectable by users
Technical alarms
prompt message Causes Alarm Solutions
Level
PVCs alarm Function Stop use of PVCs alarm and advise the biomedicine
High
limit is wrong. safety failure engineer or our companys servicemen.

- 56 -
Chapter 10RESP Measurement

10.1 Measure RESP

10.1.1 How to measure RESP

This monitor measures RESP values from the breast impedance values at two electrodes; impedance
change between such electrodes (due to breast activities) will generate a RESP waveform on the
screen.

10.1.2 Setting of RESP monitoring

For RESP monitoring, no additional electrodes are required, but how to install electrode is critical. For
some patients, especially with clinical condition that negative breast internal pressure will be
generated if their breast is horizontal expanded. In that case, users should put the two RESP electrodes
respectively at middle line of the right axilla and left side to the breast, where there are largest
activities during respiration, so as to obtain the best RESP wave.

Attention
RESP monitoring is not applicable for patients with active activities otherwise may
generate wrong alarms.

RESP monitoring checks:


Take patient skin preparation before installation of electrodes;
Install spring clamp or snap for electrodes, and follow the later-introduced method to install
electrodes on patient body;
Turn on power supply for the monitor system.

Install electrodes for RESP monitoring

- 57 -
Attention
Install the white and red electrodes in a diagonal line so as to obtain the best RESP wave.
Need keep the liver and heart area out of the line formed by such electrodes, so as to avoid
artificial discrepancy generated from heart cover or pulsatile blood, which is very
important for newborns.

10.2 RESP Setting menu (RESTP SETUP)


Users can rotate the knob and move the cursor to the RESP hotkey on the parameter area of the main
screen, then press the knob to enter the RESP Setting menu.

Figure10-1 RESPSetup

1. Alarm ON/OFF: select the ON and the alarm prompt and saving will proceed during RR alarm;
select the OFF and will be prompted beside RESP in the screen parameter area.
- 58 -
2. Alarm lever: High, Middle and Low.

3. Alarm record: If users select On, upon RESP alarming, the recorder will output the alarm.

4. Alarm levels: High, MED or Low to be selected, and High for the most serious alarm.

5. Alarm HI: used to be set with the upper limit for RR alarm.

6. Alarm LO: used to be set with the alarm lower limit.

RESP alarming takes the set upper & lower limits as standard, and once the RESP values exceed such
limits there will be alarms.

Adjustable range of RESP alarm upper & lower limits:


Max upper limit Min lower limit Adjusted amount
per time
RR infant/ newborn 150 6 1
Choke alarm: Users can set the time to judge patient choke; 10-40 seconds are optional, each rotation
of knob will increase/ decrease 5 seconds.

10.3 RESP setting in waveform area


Users can rotate the knob and move the cursor to the RESP hotkey on the parameter area of the
main screen, then press the knob to enter the RESP Setting menu.

Figure10-2RESP Setup

GAIN(Waveform amplitude): Users can set enlarged display of RESP waveforms under
five optional enlargement rates: 0.25, 0.5, 1, 2 and 4.

SWEEP(Waveform speed): Three optional speeds, 6.25mm/s, 12.5mm/s and 25.0mm/s

WAVE COLOR: green, cyan, red, yellow, white, blue, violet.

WAVE TYPE : LINE or FILL

10.4 RESP setting in measurements

- 59 -
Users can rootate the knobb and move the t cursor to the RESP hootkey on the parameter arrea of the
mainn screen, thenn press the knnob to enter thhe RESP Settting menu.

Figure 10-3 RESP


P Alarm Setupp

1. ALM ON/O OFF: see referrence in RESP P Setting mennu


2. ALM LEV: see referencee in RESP Settting menu
3. ALM REC:ssee referencee in RESP Settting menu
4. SWEEP: Waveform speeed, Three optiional speeds, 6.25mm/s, 12.5mm/s andd 25.0mm/s
5. WAVE COL LOR: see refeerence in RESSP Setting meenu
6. RR Gain: Users
U can set enlarged dissplay of RESP waveformss under four optional enlaargement
rates: 0.25, 0.5,
0 1.0, 2.0 and
a 4.0.
7. APNEA ALM :Set the tim me dignosingg a patient sufffocation .NO
O , 1s ,2s ,5s ,,10s ,15s ,20ss,
25s ,30s ,35s ,40s.
7. ALM HI: ussed to be set with
w the uppeer limit for RR R alarm.

8. ALM LO: used


u m lower limit.
to be set with the alarm
9. DEFAULT:Select this opption to enterr "default con nfiguration" dialog
d box, seelect the "Yess", that is,
using the deefault default configurationn, the originaal configuratioon will be ovverwritten, sellect "No"
to abandon the
t current opperation, the system remaiins the original configuratiion unchangeed

10.5 Mainttenance & Cleanin


ng

Notte and Clleaning

Warn
ning
Before cleeaning the monitor
m or seensor, users must turn of pment and break the
o the equip
- 60 -
AC power supply. In case of any appearance of ECG cable damage or aging, users should
change with new cables.

Cleaning
Surface of the monitor and sensor can be swept by medical alcohol, naturally dried or cleaned by
clean and dry clothes.

Disinfection
To avoid long-term damage to the equipment, we recommend you to disinfect the products only when
deemed as necessary under the maintenance plan of your hospital. We also recommend you to clean
the products before disinfection.

Recommended disinfection materials for the monitor:


Ethanol: 70% alcohol, 70% isopropyl
Glyoxyl

Sterilization
To avoid long-term damage to the equipment, we recommend you to sterilize the products only when
deemed as necessary under the maintenance plan of your hospital. We also recommend you to clean
the products before sterilization

- 61 -
Chap
pter 111SpO2
2 Mon
nitorin
ng

11.1 Definiition of Sp
pO2 Mon
nitoring
The SpO2 volum me recordingg parameter is used to measure arrterial SpO2, i.e., percentage of
oxyhhemoglobin. For example, if there are 97% of hem moglobin moleecules combiining with ox xygen out
of thhe arterial redd blood cells,, the blood will
w be describ
bed as SpO2 97,
9 and thee SpO2 readin
ng on the
monnitor will be 97. SpO2 values thus can show th he percentagee of oxygen--attached hemmoglobin
moleecules (will form oxyheemoglobin), meanwhile,
m SpO2 volume recording parameters can also
provvide the PR siignals and voolume recordiing waves.

11.1.1 Princiiple for Measurem


M ment of Sp
pO2 Volum
me Record
ding Para
ameter

BOSS (blood oxyggen saturationn) is measureed and determ mined in the method
m of pullse oximetry, which is
a meethod of meaasuring and determining
d thhe oxyhemog globin saturattion continuoously and witthout any
hurt, mainly useed to measurre and determ mine how manym rays froom the light source of th he sensor
peneetrate the patiients tissue (such as fingeers or ears) an
nd reach anothher receiver.

f the wave length meassurable by thee sensor, gen


As for nerally the red LED is 6660nm and thee infrared
LED
D, 940nm. Thhe maximum selectable
s outtput power off LED is 4mWW.

The number of penetrated


p ors where moost are consttant, but one of these
raays rests withh many facto
factoors means thhe arterial floow changes thhrough time because it iss pulsant. Thhe arterialized
d bloods
BOS S can be obtaained throughh measuremennt of absorbeed rays duringg pulsation. A volume reecording
waveform and PR R signal can be b given through detection
n of pulsationn.

SppO2 value and Volume Recording


R w
waveform can
n display on the
t main screeen.

ning
Warn
Where theere is carboxxyhemoglobin
n, ferrihemo
oglobin ordye dilution ch
hemicals, SpO
O2 value
will have a deviation.

11.1.2 BOS/P
Pulse Monitoring

Warn
ning
The cablee for the equ
uipment of electrosurger
e ry cant be twisted
t togetther with th
he sensor
cable.

Warn
ning
Please don
nt place the senor on thee limb with arterial
a duct or vein injecction syringee.
- 62 -
Attention
n
Please don o the same limb for meeasurement of blood
nt place SpO2 detector and cover on
pressure, because in the course off measuring blood pressu
ure the vascu
ular obstrucction will
affect the BOS readingg.

11.2 Precaautions in SpO2/Pullse Monittoring

Attention
n
Guaranteee the nail cann shut out th
he light.
The detecttor cable shoould be fixed
d on the back
k of hand.

Attention
n
SpO2 valuue always dissplays at the fixed place.
Only in th
he following cases
c PR willl appear:
In ECG G menu, set HR
Source as SPO2 or all.
a
In ECG G menu, set HR
Source as AUTO and there is no
n ECG signaal at this timee.

Attention
n
SpO2 waveeform and pulse are out of proportio
on.

Warn
ning

Prior to monitoring,
m the first inspection shou uld be given n to whetherr the sensor cable is
normal. SppO2 sensor cable
c being pulled
p he screen willl display the Sensor
out off the jack, th
Off mistaaken informaation, and trrigger the souund alarm.

Warn
ning
Where thee sensor pack king or the sensor
s has th
he sign of dam
mage, pleasee dont use th
his SpO2
sensor, bu
ut return it too the manufaacturer.

Warn
ning
Continuou us and overrlong monitooring may increase
i the undesirablee dangers th hat skin
features change,
c suchh as extraoordinary sen nsitivity, redddening, bliistering or pressure
necrosis, which are especially
e eaasy to happpen to the newborns oor the patien nts with
perfusion disorder or immature skin.
s In such
h a case speccial attention n should be given to
aiming the correct beeam path at detection off sensor posiition accordiing to the ch hange of
skin qualiity. Regular inspection shhould also be
b given to th he laid-on poosition of sen nsor and
the changee of such a position
p whenn the skin quuality goes worse.
w It is poossible to req
quire for
the more frequent
f insp
pection due to
t different patient
p status.

- 63 -
11.3 Monitoring Procedures
(1)SpO2 volume recording measurement:
Turn on the monitor;
Paste the sensor on a proper position of the patient finger;
Insert the connector at the other side of the sensor cable into the SpO2 hole of theSpO2 module.

Figure 11-1 placement of senseor

(2)Neonate SPO2 measurements


The measurement method for neonate is almost the same with adult, the sensor is introduced
below.
1. neonate SPO2 sensor

Neonate SPO2 sensor includes Y type SPO2sensor and SPO2sensor jacket, put the LED end of Y type
SPO2sensor into the SPO2sensor jacket, refer to the Figure below

Y type sensor SPO2sensor jackte

Figure 11-2 neonate SPO2 sensor1

Figure 11-3 neonate SPO2 sensor2

2. The placement for the neonatal SPO2 sensor


- 64 -
Put the neonatal SPO2 sensor on hand or foot of neonate patients (Figure11-4). Fix the SPO2 sensor in
the right position.

Figure 11-4 The placement for the neonatal SPO2 sensor


(3)Nellcor SpO2

NELLCOR SpO2 transducer is consist of Nellcor SpO2 connection cable, Nellcor infant SpO2 sensor,
and wraps, as picture shown:

Consist of Nellocr SpO2

Connection between extension cable and sensor

Fix Nellcor SpO2 sensor

- 65 -
11.4 Measurement restriction
Measurement restriction
During operation, the following factors may affect accuracy of SpO2 measurement:

High-frequency electric disturbance, such as disturbance generated from the system itself
or electrosurgery equipments connected with the system;
A photo-oximeter and SPO2 sensor are used during MRI process, as the inductive current
may cause burns;
Intravenous Dye;
Frequent movement by patient;
Light radiation from outside;
Improper installation of the sensor or improper touching position with objects;
Improper sensor temperature (ideal temperature should be 28-42);
The sensor is put onto body with blood pressure cuff, arterial duct or vein tube;
Contents of non-functional Hb such as COHb and MetHb;
SPO2 over low;
Bad microvascular perfusion at the test position;
Shock, anemia, low temperature and application of vessel shrinking medicines, which all
can reduce the arterial blood flow to a non-measurable level;
Measurement is also up to absorption of lights with special wavelengths by
oxyhemoglobin and deoxygenated hemoglobin. Existence of other materials that absorbs
the same wavelengths, such as carbonated hemoglobin, hemoglobin, methylene blue and
indi carmine, will make artificial or low SPO2 values.
SPO2 sensor introduced in the accessory is recommended.

11.5 SpO2 Setting menu


Users can rotate the knob and move the cursor onto the SPO2 hotkey in the parameter area, then press
the knob to enter the SpO2 Setting menu.

Figure11-5SPO2Setup

- 66 -
Warning
Setting the SpO2 alarm upper limit to be 100% mea ans to releasee the upper llimit. Howevver, high
SpOO2 level will make earlyy-born infantts infected with
w ntal fibroplaasias, thus the SpO2
retrolen
alarrm upper lim
mit must be carefully seleected based on
o common acknowledge
a ed clinical prractice.
Alarm ON/O OFF: Where ON is selected, the alarrm prompt annd saving willl proceed whhen SpO2

(BOS) is alaarmed; wheree OFF is sellected, alarm


ming will not happen,
h but will be prompted
p
beside SpO22 in the screenn parameter area.
a

Alarm level: used to set alarm levels and, during SpO2


S alarminng, for alarm reminder and saving.
Options incllude High, Middle, annd Low; HHigh for the most serious alarm.(This feature
f is
only effectivve NELLCOR R blood-oxyggen)

Alarm recorrd: If On is selected, the recorder will output durinng SpO2 alarm
ming.

SPO2 ALM M SETUP:setuup SPO2 higght limit ,miiddle limit ,llow limit of the upper an nd lower
limits .( If the monitor SPO2 is NE
ELLCOR, seetup alarm lim mit, have noot hight limitt ,middle
limit ,low lim
mit )

PR ALM SETUP: setupp pulse rate highth limit ,m


middle limit ,low
, limit off the upper an
nd lower
limits . ( Iff the monitorr SPO2 is NE
ELLCOR, seetup alarm liimit, have noot hight limitt ,middle
limit ,low limmit )

Massimo SPO2 caan can autom matically identtify the hardw


ware inside thhe machine , the following featuea
is onnly effective Masimo
M bloood-oxygen , iss unchangeab ble items.

DSP VERSIION:2.0.1.7

HARD VER
RSION:0.1.0.1

PRODUCT ID:0.0.0.1

SION:0.0.0.0
MCU VERS

SENSOR TY
YPE: no senssor

O2& PR adjusttable limits:


SpO
Parameter Max uppeer limit Min lower liimit Addjustable am
mount
eaach time
SpO2 100 0 1
PR 254 0 1

11.6 SPO22 setting in


n waveforrm area
Userrs can rotate the knob andd move the cuursor onto thee SPO2 hotkey in the param
meter area, th
hen press
the knob
k to enter the SpO2 Settting menu.

- 67 -
Figure11-6 SPO2Setting

SWEEP: Waveform Speed, the scanning speed of SpO2 volume recording waveform is provided
with 12.5 and 25.0mm/s for option.
Waveform Colour: green, cyan, red, yellow, white, blue, violet.
Wave type: line or filled.(Masimo SPO2 have not the feature)

11.7 SpO2 Setting in measurement menu

Figure 11-7 SPO2 setup

ALM ON/OFF: see the content of this chapter parameter area the SPO2 set the ALM ON/OFF

ALM LEV: see the content of this chapter parameter area the SPO2 set " ALM LEV ".(This
feature is only effective NELLCOR oxygen)

ALM REC: see this chapter parameter area the SPO2 set ALM REC.

SWEEP: see this chapter waveform area the SPO2 set "SWEEP.

WAVE COLOR:.see this chapter waveform area the SPO2 set "WAVE COLOR
- 68 -
Apnea alarm1,2,5,10,20,25,30,35,40 not alarm. This setting, monitor patients detected asphyxia,
how long instrument alarm signal.

Satsecond 10, 25, 50, 100 seconds, disable, for example, intelligent alarm range is set to 50,
then when NELLCOR oximeter alarm limit 97, and the lower limit is 90, and the measured
oxygen value is 99, then from exceeding the alarm limit commences consecutive exceeds the
alarm limit of 25 seconds as soon as they sound and light alarm at the same time the oxygen
values next to the circle and draw back to square one. The intelligent alarm to reduce false alarms,
allow doctors to more accurate and timely master oxygen changes. (This feature is only effective
NELLCOR blood-oxygen)

SAMARTTONE:On, Off. When this menu is started, "signaling" and "pulse audio" are
simultaneously turned on, they can be smartly managed. However, turning off the menu cant
manage these two. (This feature is only available on the Masimo blood-oxygen)

SIGNAL IQ:Turning on and off.When it is turned on, below the SPO2 waveform, there is a logo
for signal collection, which is mainly reflecting the quality of the signal during the acquisition
process. The signal disappears as it is turned off. (This feature is only available on the Masimo
blood-oxygen)

BEEP:on, off. Turning on the pulse sound, you can get a prompt of PULSE (pulse) sound. No
PULSE (pulse) sound prompt as it is turning off. (This feature is only available on the Masimo
blood-oxygen)

FAST SAT: On, Off. When you start the rapid blood-oxygen measurements, you can
choose "on ", also off not using this feature. (This feature is only available on the
Masimo blood-oxygen)

AVE TIME(S):2-4, 4-6, 8s, 10s, 12s, 14s, 16s. The average time, SPO2 value displayed on the
monitor, is the result of averaged data collected during a period of time. The shorter the average
time, then the faster is the monitors response to the patient's SPO2 value changes, but lower
measurement accuracy. Conversely, the longer it is, the more slowly the monitors response to the
patient's SPO2 value changes, but the higher the measurement accuracy will be. In the care of
critically ill patients, to set a smaller average time is beneficial to the immediate analysis of the
disease. (This feature is only available on the Masimo blood-oxygen)

SENSITIVE:normal, sensitive, APOD. According to the level, "APOD" has the highest
sensitivity. For typical patient monitoring, use the "normal" sensitivity. As for those patients who
have moist skin, active exercise, or for other reasons, the probe may be dropped off a patient's
body, then use the sensitive " sensitivity. If the patient has very low perfusion levels and wants
to improve the sensitivity performance, please use the APOD sensitivity. (This feature is only
available on the Masimo blood-oxygen)

SPO2 ALM SETUP: see the content of this chapter parameter area the SPO2 set alarm settings.

PR ALM SETUP: see the content of this chapter parameter area the SPO2 set alarm settings.

DEFAULT: Select this option to enter the the SPO2 default configuration dialog box, the user can
choose "yes" or "no" to "will be the default configuration" or "original configuration will be set.

- 69 -
11.8 Alarms & Reminders

SpO2 alarm information


When the alarm record function under certain menus is on, those physical alarms caused because
relevant parameters exceed the specified alarm limits will automatically output alarm parameter
values and relevant measurement waveforms.

11.9 Maintenance & Cleaning

Warning

Users must turn off the equipment and shut down the AC power supply before cleaning
the monitor or the connected sensor.

Careful

Please dont sterilize the senor with pressure.


Please dont soak the sensor in the liquid.
Use of the senor or cable is prohibited if they are damaged or degenerated.

Cleaning:
Having cleansed the surface of the sensor with the cotton ball or cotton cloth soaked with medical
alcohol, dry it with the dry cloth. The luminotron and receiver of the sensor can be cleaned in the same
method. The cable can be cleaned and sterilized with 3% of hydrogen peroxide or 70% of isopropyl
alcohol. Active reagent can also be used for this purpose. However, the joint cant be soaked in the
above solution.

- 70 -
Chapter 12NIBP Monitoring

12.1 General Information


NIBP measurement can be performed in the oscillation method;
It can be used in adults, children and newborns;
Measurement mode: manual, automatic and continuous measurement. Each mode can show NS, NM
and ND.
Manual mode: measurement can only be done once.
Auto mode: measurement can be repeated. The interval time can be set as
1/2/3/4/5/10/15/30/60/90/120/180/240/480 minutes.
Continuous mode: measurement can continuously be done within 5 minutes.

Warning

Dont apply NIBP measurement onto a patient with sickle cell disease or any skin damage
or expected to have skin damage.
For patients with serious DIC, users should decide whether to apply NIBP measurement
based on clinical assessment, as there may have blood tumor at the touching area between
body and cuff.
In case of measurement on infants and newborns, users must ensure to select the correct
mode setting (refers to Patient Information Menu setting). A wrong mode may threaten
patient safety, as adult blood pressure levels are too high to be applied on infants and
newborns.

12.2 NIBP Monitoring

12.2.1 NlBP Measurement

Warning

Before measurement, users must make sure the selected monitoring mode is applicable for
the patients (adult, infant or newborn).
Dont install a cuff on a body part with vein duct or other tubes. During cuff pumping,
slow infusion or infusion blocking may cause damage to the surrounding body area.

Warning

The pumping pipe connecting blood pressure cuff and the monitor must be smooth,
without any entanglement.
- 71 -
1. Insert the pumping pipe into the interface of a blood pressure cuff and turn on the power
supply.
2. In accordance with the following method (Pic 14-1), tie the blood pressure cuff on upper
arm of upper leg of a patient.
Confirm the cuff is fully vented.
Select a cuff in proper size for the patient, and make sure the mark is just along the proper vein and
cuff tie the body non-toughly, otherwise remote body part may have color change or even ischaemia.

Figure12-1Use of a Cuff

Neonate NIBP cuff


Different four size of Philips NIBP cuff for neonate monitoring

Attention
Cuff width should be 40% of arm perimeter (50% in case of newborns) or 2/3 of upper arm
length. Width of the pumping part of a cuff should be as long as to surround 50%~80% of the
arm. Cuffs in improper size will generate wrong readings. In case of size problem with a cuff,
users should change it with a bigger one so as to reduce mistakes.

NeonateReusable NIBP cuff


Patient Type Body Perimeter Cuff width NIBP
extension air
tube
Neonate 10 ~19 cm 8 cm
1.5 m or 2m
Leg 46 ~ 66 cm 21 cm

neonateone-time cuff
size Circular of arm Cuff width Tube length
- 72 -
1 3.1 ~ 5.7 cm 2.5 cm
2 4.3 ~ 8.0 cm 3.2 cm
1.5 m or 3 m
3 5.8 ~ 10.9 cm 4.3 cm
4 7.1 ~ 13.1 cm 5.1 cm

3. Check the cuff edges are between the <-> marks; otherwise users should change with a more
proper cuff.

4. Connect the cuff with a pumping pipe. Make sure the body part used for pressure measurement is
at the same horizontal level with patient heart, and if failing to realize this, users should apply the
following correction method to correct the measurement results:

In case horizontal level of cuff is higher than that of heart, add 0.75mmHg (0.10kPa) onto the
displayed value for each cm difference.

In case horizontal level of cuff is lower than that of heart, deduct 0.75mmHg (0.10kPa) onto the
displayed value for each cm difference.

5. Confirm correctness of the monitoring mode (as displayed on the information area); if requiring to
change the monitoring mode, users need go to the Patient Information Setting item under the
Main menu and change Patient Type.

6. Select the measurement mode under the NIBP menu. Refer to the following Operational Guide for
details.

7. Press the START button on the front panel to start pressure measurement.

Operational guide
Conduct one time of Automatic measurement

Enter the NIBP Setting menu, select a proper time interval at the Time Interval item, and press the
START/STOP button on the front panel. Then the system will start automatic pumping
measurement in the specified time interval.

Warning

If NIBP measurement under the Automatic mode lasts too long, body touching with the cuff
may have allergic purpuras, ischemia and neural injury. During monitoring on patients, users
should often check color, warmness and sensitiveness of remote body parts. Once any abnormal
phenomenon is found, users should put the cuff at another location or immediately stop
measuring blood pressure.
Stop automatic measurement

At any moment during the automatic measurement process, press the START/STOP button will stop
the automatic measurement.

Conduct one time of manual measurement

Enter the NIBP Setting menu, select the Time Interval item and set its value as Manual, then
- 73 -
press the START/STOP button on the front panel so as to start manual measurement.
During spare time of an automatic measurement, press the START/STOP button will start a manual
measurement; then if users press the START/STOP button again, the manual measurement will stop
and the automatic measurement will continue.

Conduct a manual measurement during automatic measurement process

Just press the START/STOP button on the control panel.

Stop a manual measurement

Re-press the START/STOP button on the control panel.

Conduct a continuous measurement

Enter the NIBP Setting menu and select the Continuous item to start a continuous measurement,
which will always last 10 minutes.

Warning

If NIBP measurement under the Automatic mode lasts too long, body touching with the cuff
may have allergic purpuras, ischemia and neural injury. During monitoring on patients, users
should often check color, warmness and sensitiveness of remote body parts. Once any abnormal
phenomenon is found, users should put the cuff at another location or immediately stop
measuring blood pressure.

Stop continuous measurement

At any moment during the continuous measurement process, press the START/STOP button will stop
the continuous measurement.

Attention
In case of suspecting reading accuracy, users should take possible methods to check life signs of
patients before checking the monitor,

Warning

In case any liquid is sprayed onto the equipment or its accessories, especially when the liquid
may enter the tube or monitor, please contact with the maintenance department of your
hospital.

Measurement restriction

Vibration measurement has its restriction subject with patient conditions. This measurement method
looks for regular pulse waves generated from arterial pressure, so when patient conditions make this
wave detection method hard to work, measured values are no more reliable and measurement time last
longer. Users must understand the following cases will disturb the measurement method, making
measured press unreliable or measurement time extended. In such cases, patient conditions disable
- 74 -
measurement to be continued.

Patient movement

In case a patient is moving, shaking or convulsing, measurement will be unreliable or even


impossible; as such scenarios will disturb detection of arterial pulse and extend measurement
time.

Arrhythmia

In case a patient shows irregular heartbeats resulted from arrhythmia, measurement will be
unreliable or even impossible, while measurement time will also be extended.

Heart-lung machine

If a patient is connected with an artificial heart-lung machine, measurement cant be realized.

Pressure change

Within certain time if the patient blood pressure immediately changes while users are analyzing
arterial pulse so as to obtain measurement values, measurement will be unreliable or even
impossible.

Serious shock

In case a patient is under serious shock or extreme low temperature, measurement will be
unreliable as reduction in blood flowing peripherally will result reduction in arterial pulse.

HR limits

In case of HR lower than 40bpm or higher than 240bpm, no blood pressure measurement can be
done.

12.2.2 NIBP Parameter Setting & Adjustment

NIBP measurement results and relevant information are laid on screen as follows:

Measurement Time

BP Unit

Measured Value

Measuring Mode

Present cuff with pressure


Prompt Area

12.3 NIBP setting in parameter area


- 75 -
Rotate the knob, move the cursor onto the NIBP hotkey in the parameter area, and then press the knob
to enter the NIBP Setting menu.

Figure12-2NIBP Setup
Alarm switch: Where ON is selected, the alarm prompt and saving will proceed when the

pressure is alarmed; where OFF is selected, alarming will not happen, but will be
prompted beside NIBP in the screen parameter area.

Alarm record: Users can select On to output through recorder when blood pressure alarms
happen

Patient type neonate

INTERVAL: MANUAL and auto(1min, 2min , 3min, 4min, 5min ,10min ,15min ,30
min ,60min ,90min ,120min ,180 min ,240 min ,480min)

Display Colour: green, cyan, red, yellow, white, blue, violet.

NIBP SYS / NIBP MEA / NIBP DIA ALM STEUP: set the valve of NS ,NM ,ND high
limit ,middle limit ,low limit

Neonate:

NS: upper limit: 42-135 mmHg lower limit: 40-133 mmHg

ND: upper limit:12-95mmHg lower limit:10-93 mmHg

NM: upper limit:22-110 mmHg lower limit:22-108 mmHg

12.4 NIBP setting in measurements


Users can rotate the knob and move the cursor onto the SPO2 hotkey in the parameter area, then press
the knob to enter the NIBPSetting menu.
- 76 -
Figure12-3NIBP Setup
Alarm ON/OFF: Where ON is selected, the alarm prompt and saving will proceed when the

pressure is alarmed; where OFF is selected, alarming will not happen, but will be
prompted beside NIBP in the screen parameter area.

Alarm record: Users can select On to output through recorder when blood pressure alarms
happen

Unit: mmHg/kPa

Patient type neonate

Interval: Time interval (Unit: minute) for automatic measurement: 1, 2, 3, 4, 5, 10, 15, 30, 60, 90,
120, 180, 240, 480 minutes, Manual, and Continuous. After users select an interval, there will be
a display of Please press the START/STOP button in the NIBP reminder area, then users just
press the button to start pumping for the first time of automatic measurement. To end the
automatic measurement and return to the manual mode, users need only select Manual during
the measurement interval.

DISP Colour: green, cyan, red, yellow, white, blue, violet.

NIBP SYS / NIBP MEA / NIBP DIA ALM STEUP: set the valve of NS ,NM ,ND high
limit ,middle limit ,low limit.

RESET : reset of measuring status of blood pressure pump. Press the reset button, the inflated
value of blood pressure pump will recover the initial settings. When blood pressure pump is not
working properly but the monitor does not question why, this is the recommended key. Because it
allows self checking of blood pressure pumps, allowing automatic recovery of pump exception
due to some accident.

CONTINAL : After select continuous measurement, the menu will disappear automatically and
continuous measurement starts immediately; If you want to stop it, press the key of blood
pressure measurement on the shell.
- 77 -
CALIBRATE : (pressure calibration); For calibration of NIBP pressure, it should be carried out
at least every two years or when do you think the value is not accurate.

PENUMATIC(Leak detection):For detecting the closed conditions of NIBP gas path.

DEFAULT: Select this item to enter "NIBP default settings" dialog box, the user can choose "no"
or "Yes" to exit or select "the default configuration is to be used, the original configuration will
be overwritten.

Calibration
The manufacturer recommends to use pressure meter or mercurial sphygmomanometer with calibrated
precision higher than 1mmHg for calibration. Users can select the Calibration item to start calibration,
while this item turns to be Stop calibration; if at such moment press the button, the system will stop
calibration.

Warning

Calibration for NIBP measurement should be done every two years (or conducted following the
maintenance plan of your hospital). Please follow the following details to check its performance.

1) Calibration procedures of a pressure sensor:


Use a metal container of 500ml5 to replace cuff. Connect a calibrated standard pressure meter
with inaccuracy less than 0.8mmHg, T-interface ball pump and the pumping tube into the NIBP holes
on the module. Set the monitor to be under Standard mode, then take the ball pumps to pump the
metal container to be 0, 50 ad 200mmHg; in such cases values of standard pressure meter and press
values indicated on the monitor will differ within 3mmHg, otherwise please contact with our
Maintenance engineers.

Figure 12-4 Connection for NIBP calibration

Gas leakage detection


This button is used to detect gas leakage from the NIBP measurement pump. Users, after connecting
with a NIBP cuff, can use this button to start NIBP pumping process so as to observe whether the
NIBP gas route is sealed well. If such a gas leakage test gives a good result, the system will make no
- 78 -
reminder, otherwise there will be the corresponding error reminder in the NIBP information area.
Default Setting
Users can select this item to enter the NIBP Default Setting dialogue box, then further select
Manufacturer Default or User Default. After making a selection, the system will eject a dialog box
for confirmation of selection by users.

Warning

This gas leakage test, different from as described in the EN 1060-1 Standard, is only for
users to simply detect gas leakage during NIBP pumping process. In case the system shows
there is NIBP gas leakage, please contact with our maintenance engineers.

2) Gas leakage detection process:


Properly connect the cuff with the NIBP hole of the monitor.
Wrap the cuff onto a column body in proper size.
Enter the NIBP Setting menu
Rotate the knob, move the cursor onto the Gas Leakage Detection item, then press the knob. There
will be a reminder of Gas leakage detection in progress at bottom of the NIBP parameter area of the
screen, meaning the system has started executing gas leakage detection
The system automatically pumps to the pressure of 180mmHg.
In about 20 seconds, the system will automatically open the air bleeder, indicating completion of gas
leakage measurement.
No reminder information displaying on the NIBP parameter area doesnt mean no gas leakage within
the system. Display of Pump leaking means there is possible gas leakage with the gas route, in
such case operators should check whether there is any loose connection, and after making sure of no
more loose connection re-do the gas leakage detection; if the error reminder is still displayed, please
contact with the manufacturer for repair

Figure 12-5 Connection for NIBP Gas Leakage Detection

12.5 NIBP alarm information


Provided that the alarming record function under relevant menu is turned on, those physical alarms
activated because parameters exceed alarming limits may activate the recorder to automatically output
- 79 -
alarming parameter values and the relevant measurement waveforms. The following table lists various
possible alarms during NIBP measurement process.
Physical alarms:
Reminders Causes Alarming levels
NS over-high Measured NIBP systolic pressure higher than specified User defined
alarming upper limit
NS over-low Measured NIBP systolic pressure lower than specified User defined
alarming lower limit
ND over-high Measured diastolic pressure higher than specified alarming User defined
upper limit
ND over-low Measured diastolic pressure lower than specified alarming User defined
lower limit
NM over-high Measured average pressure higher than specified alarming User defined
upper limit
NM over-low Measured average pressure lower than specified alarming User defined
lower limit

Technical alarms 1 (displayed in the monitor information area):

Alarming
Reminders Causes Solution
levels
Function/ Stop using the NIBP module alarming
NS alarming limit
safety High function and inform biochemical engineers
error
failure or our maintenance team
Function/ Stop using the NIBP module alarming
NM alarming limit
safety High function and inform biochemical engineers
error
failure or our maintenance team
Function/ Stop using the NIBP module alarming
ND alarming limit
safety High function and inform biochemical engineers
error
failure or our maintenance team

Technical alarms 2 (displayed in the reminder area below NIBP values):

Alarming
Reminders Causes Solution
levels
Stop using the NIBP measurement
NIBP self-detection Sensor or other
High function and inform biochemical
error hardware failure
engineers or our maintenance team
Communication
If the failure continues, stop using the
NIBP failure with
NIBP measurement function and inform
communication NIBP High
biochemical engineers or our maintenance
error measurement
team
module
Cuff isnt
Cuff loose or out of properly
Low Wrap the cuff properly
connection wrapped or no
cuff
Damage with Check and change the part with leakage,
Gas leakage with
cuff, pipe or Low and if necessary also inform biochemical
cuff pumping pipe
connector engineers or our maintenance team
Fail to obtain
Check whether there is pipe wrapping; if
stable pressure
the problem continuous, inform
Air pressure error value, e.g., Low
biochemical engineers or our maintenance
because of pipe
team
wrapping
Signal too weak Cuff too loose Low Apply other methods to measure blood
- 80 -
or patient pulse pressure
too weak
Reset the NIBP measurement module;
Measurement
and if the problem continuous, stop using
Pressure out of scope exceeding
High the NIBP measurement module and
scope specified upper
inform biochemical engineers or our
limit
maintenance team
Big signal noise
or irregular PR Make sure the patient is silent, without
Arm movement Low
due to arm movement
movement
Pressure Re-measure. If the problem continuous,
Overpressure exceeding stop using the NIBP measurement module
High
protection specified upper and inform biochemical engineers or our
limit maintenance team
Significant
Signal saturation Low Stop the patient from movement
movement
Check and change the part(s) with
Leakage during leakage, and if necessary, inform
Pump leakage Low
the leakage test biochemical engineers or our maintenance
team
Blood pressure Stop using the NIBP measurement
NIBP system failure pump system High function and inform biochemical
running failure engineers or our maintenance team
Current cuff
Wrong cuff type type not suitable Low Select proper cuff
for patient
Measurement
time over 120
Measurement time seconds (for Re-measure or apply other measurement
High
out adults) or 90 methods
seconds (for
newborns)
Module reset
NIBP reset error High Re-use the reset function
improperly
During
measurement
the system can Check the cuff and re-measure while
Measurement error not execute High making sure the patient is silent during
measurement monitoring
analysis or
calculation

Reminders (displayed in the reminder area below NIBP values):

Reminders Causes Alarming levels


Manual measurement Manual measurement in process
Continuous measurement Continuous measurement in process
Automatic measurement Automatic measurement in process
Please press START After you select the measurement time No alarm
interval
Measurement stopped During measurement users press the START
button to stop measurement
Calibration Calibration in process
Calibration stopped Calibration completed
Gas leakage detection Gas leakage detection in process
Gas leakage detection stopped Gas leakage detection is stopped
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Module reset Reset after NIBP module is loaded
Manual reset NIBP reset (activated by users) in process
Fail to reset Fail to reset

12.6 Maintenance & Cleaning

Warning

Dont compress the rubber pipe on a cuff.


Keep water or cleaning liquids out of the connector socket in the front of the monitor, otherwise
the equipment may be damaged.
During monitor cleaning, users need only sweep the outer surface of theconnector socket instead
of its inner surface.
In case a recyclable cuff is disconnected with the monitor or being cleaned, users should locate
the cover cap above the rubber pipe so as to prevent any liquids from entering the rubber pipe
and being absorbed into the module.

12.6.1.1 Recyclable blood pressure cuff


Normally cuff may be disinfected within a hot air cabinet under the high pressure, gas or radiation
disinfection methods or sterilized by immersion into decontamination solutions. But users must take
away the rubber bag when applying such methods. Cuff can not be dry washed but machine washed or
hand washed only, and hand wash can extend service life of cuff. Before cleaning, users should take
away the rubber bag and put back after cleaning and cuff drying.

- 82 -
Figure 13-8 Change the tape inside cuff

To put the rubber bag back into the cuff, users should put the rubber bag near the cuff opening side,
making the rubber pipe aligned with the long opening of the cuff, then vertically roll the rubber bag
and insert it into the long opening, hold on the rubber pipe and cuff, and then shake the whole cuff
until the rubber gag is positioned exactly. Insert the rubber pipe into the cuff, letting it go through the
hole liner and extend out.

12.6.1.2 One-time blood pressure cuff


Cuffs for one-time use can only be used for one patient. Dont use the same cuff with different patients.
Dont take one-time cuffs for disinfection or high-pressure vapor sterilization. However, users can use
soap to clean one-time cuffs for infection control purpose.

Caution

To protect the environment, one-time blood cuffs after use must be recycled or properly
treated.

- 83 -
Chapter 13TEMP Monitoring

13.1 TEMP Monitoring


The monitor has two TEMP measuring channels. The temperature data can be measured with the
TEMP detector.Teperature is not a standard configuration for the neonatal monitor.

TEMP measurement setting

For one-time TEMP detectors, users must insert the TEMP cables into slots and then connect the
detectors with such cables; for reusable TEMP detectors, users can directly insert them into slots.
Closely paste TEMP detectors with patient body.
Turn on the system power supply.

Warning

Before monitoring users should check status of detector cables by plugging out the TEMP
detector cable from the hole, then the screen will display the error information T sensor
disconnected and make voice alarming.
Attention
A one-time TEM detector can only be used once.

Warning

Be careful to use or store TEMP detector and cables; spare detectors and cables should be
wrapped into loose rolls. Tough wires inside the detector and cables, if any, may cause
mechanical injury.

Warning

Calibration of a TEMP detector must be done for every two years or comply with your
hospitals specified schedule. When requiring calibration, please contact the manufacturer.
Attention
During monitoring process a TEMP detector will self-detect once per hour; such self-detection
last for 2 seconds and will not affect normal work of the TESP monitor.

13.2 TEMP setting in parameter area


Users can use the knob to move the cursor onto the TEMP hotkey in the parameter area and press the
knob to enter the TEMP Setting menu.

- 84 -
Figure13-1TEMP setting
Alarm ON/OFF: Select ON and the alarm prompt and saving will proceed when TEMP is

alarmed; select OFF and no alarm will happen, but will be prompted beside TEMP in the
screen parameter area.

Alarm levels: High, Middle or Low to be selected by users to set alarming levels.

Alarm Record: it is mainly used in starting/closing the output function of TEMP alarm record. If
On is selected, the present TEMP alarm will be outputted through the recorder.

Disp Color: green, cyan, red, yellow, white, blue, violet.

T1\T2 ALM HI/LO: Temperature alarm is set high limit and low limit alarm when the
temperature exceeds the high limit or below the lower limit.

TD ALM HI: Temperature alarm is set high limit when the temperature exceeds the high limit

13.3 TEMP setting in measurements

Figure13-2 TEMP setting


Alarm ON/OFF: Select ON and the alarm prompt and saving will proceed when TEMP is
alarmed; select OFF and no alarm will happen, but will be prompted beside TEMP in the
- 85 -
screen parameter area.

Alarm levels: High, Middle or Low to be selected by users to set alarming levels.

Alarm Record: it is mainly used in starting/closing the output function of TEMP alarm record. If
On is selected, the present TEMP alarm will be outputted through the recorder.

TEMP unit: or

Disp Color: green, cyan, red, yellow, white, blue, violet.

T1\T2\TD ALM HI/LO: Temperature alarm is set high limit and low limit alarm when the
temperature exceeds the high limit or below the lower limit.

TD ALM HI: Temperature alarm is set high limit when the temperature exceeds the high limit.

Default: Please refer to the ECG Default Setting in the ECG/TEMP Monitoring.

13.4 Alarm information and prompt information


In case the alarm record function under relevant menus is enabled, those physical alarms caused
because relevant parameters exceed relevant alarming limits will activate the recorder to automatically
output alarming parameter values and relevant measurement waveforms. The physical alarms,
technical alarms and reminders possible happening during TEMP measurement are listed as follows:

13.5 Maintenance & Cleaning

Warning

Users must turn off the equipment and shut down the AC power supply before cleaning the
monitor or the connected sensor.

This monitor is compatible with YSI400 series TEMP detectors, whose cleaning procedures are as
follows:

Reusable TEMP detectors:

Heating onto a TEMP detector can not be over 100oC (212.F), as such detector can only undertake
80oC (176.F) --100oC (212.F) within short period.

Detectors can not be vapor disinfected.


Only cleaning agents with alcohol can be used for disinfection.
During use of straight detectors, users should cover them with protective adhesive.

When cleaning detectors, users should use one hand to hold on one end and the other hand to
downward hold wet lint-free cloth to wash detectors towards the connector direction.
- 86 -
Attention
If you are using a one-time TEMP detector, this detector is allowed to be re-disinfected or
reused.
Attention
To protect the environment, one-time TEMP detectors should be recycled or properly treated.

- 87 -
Chapter 14CO2 Monitoring

14.1 General information


Monitor adopts Sidestream and Mainstream CO2 measurement modes. The module measures CO2
pressure (PCO2) to get end-tidal CO2 (EtCO2), inspiratory CO2 (InsCO2) and air way respiration rate
(AWRR) and displays pressure waveform of CO2.

Warning

Avoid hit or vibration of carbon dioxide as far as possible.

Caution

Dont use the instrument in an environment with inflammables or anesthetic gas.


The instrument can only be operated by professionals having received career training and
possessed a good knowledge of the Manual.
Select the Module Setup option in the monitor setup menu and set the CO2 on-off to be on. The
following figure (the present figure is in demonstrating mode) will come out:

Figure14-1 Main interface of CO2 module

14.2 Measuring principle and working procedure


The CO2 measuring principle is mainly based on the characteristic that CO2 can absorb the infrared
rays having a wavelength of 4. 3um. The measuring method works as follows:Gaseous CO2 is
introduced to a measuring chamber of which one side is irradiated by infrared rays, and sensors are
- 88 -
employed to measure the attenuation degrees of received infrared rays at the other side of the
measuring chamber, and the attenuation degree is directly proportional to the CO2 concentrations.

The comparison expression for the conversion between CO2 partial pressure and CO2 concentration is:

CO2 Partial Pressure (mmHg)= CO2 Concentration (%)Pamp (Ambient Pressure)

For example:5% CO2 = 38mmHg at 760mmHg

5% CO2 = 35mmHg at 700mmHg

CO2 Module:adopting Autorun instruction measurement mode, and the waveform is sampled once in
every 31 milliseconds.

14.3 Operating Instruction for CO2 Connection


(1) The schematic of connection of the mainstream module produced by the RESPIRONICS
company is shown in the figure below:

Figure 14-2 Mainstream Mode CO2 Connection


The schematic of connection of the sidestream module produced by the RESPIRONICS company is
shown in the figure below:

- 89 -
O2 Connection Schematic
Figure 14-3 Sidestreeam Mode CO
The schematic off connection of
o the ISAsidestream an
nalyzer produuced by the P
PHASEIN com
mpany is
show
wn in the figuure below:

Samplingg tube

Figurre 14-4ISA
Sidestream Analyzer
A (ISA
A CO2) CO2 Connection S
Schematic

The schematic of
o connection of the IR RMA main
nstream analyyzer produceed by the PH
HASEIN
com
mpany is show
wn in the figurre below:

Figure 14-5 IRMA


Mainstream Analyzer (IR
RMA CO 2) CO
C 2 Connectioon Schematicc

The monitoring equipment produced byy this company supportss CO2 meassurement by using a
sidestream or mainstream module producced by the IRONICES company,
c or an ISA siidestream
analyzer (ISA CO
O2 (CO2) CAT
T. NO. 8001001) produced by the PHAS
SEIN companny.

A
Attention
- 90 -
When an ISA sidestream analyzer (ISA CO2 (CO2) CAT. NO. 800101) produced by the
PHASEIN company is used for monitoring CO2, please refer to the contents of the section titled
17.6 Measuring Procedure and Before-Using Checking for the measuring procedure, and
change the procedure for setting the AG module menu to CO2 menu setting.

Warning
Before use, please check airway joints. Do not use when visible damage or breaks are found on
the airway adapter.

Warning
When CO2 is not used, it must be turned off, otherwise the CO2 module will be in a working
condition all the time

14.4 CO2 Measurement Procedures


Based on different CO2 modules used, determine if it is necessary to set such menu items as Oxygen
Compensation, Balancing Gas, Altitude and Atmospheric Pressure etc for the instrument.
When an ISA sidestream analyzer (ISA CO2 (CO2) CAT. NO. 800101) produced by the PHASEIN
company is used, if there are no such settings as altitude and atmospheric pressure etc, it means that
such functions have been carried by the module itself, need not to be set manually. Please refer to the
instruction manual coming with the module.

If you need the CO2 alarm message function, you can set this function in CO2 Settings.

14.5 Measuring Procedure of RESPIRONICS Branded Mainstream

and Sidestream Modules


The RESPIRONICS branded sidestream analyzer operating procedure is roughly the same as the
mainstream analyzer operating procedure; please refer to the sidestream analyzer operating procedure
for the mainstream analyzer operating procedure.

(1) Start the host monitoring equipment (if a minihost is used, please start the minihost monitoring
equipment at the same time).

(2) Or insert the CO2 plug-in module into the host monitoring equipment; the indicator of the CO2
plug-in module will illuminate, which means that the module has been successfully connected to
the host monitoring equipment; otherwise, please reinsert the CO2 plug-in module.

(3) Make connections according to the CO2 module type or Figure 15-4 or Figure 15-5, and connect

- 91 -
the CO2 module interface cable to the CO2 interface of the CO2 plug-in module or the minihost.

(4) Enter into the conventional screen of the host monitoring equipment, select [Exchange Waveform]
to call out the CO2 waveform and parameters which you want to monitor, such as [CO2] (this
step can be skipped if the screen has already displayed the CO2 waveform and parameters).

(5) When the CO2 module is connected to the monitor, its module working mode is in the
Measurement state; however, in order to make sure that it is in the correct working state, please
do enter into the [CO2 Settings] menu to set its Working Mode to the [Measurement] mode.

(6) Set [CO2 Switch] to [On].

(7) In the [CO2 Settings] menu, set [Oxygen Compensation] to 21 (usually, although it is 21 in this
menu, in order to make sure that its datum is in an activated state, the customer still needs to
reselect it);

(8) In the [CO2 Settings] menu, select an appropriate [Balancing Gas]:Indoor air, laughing gas or
helium (usually if there is no unused laughing gas or helium indoors, you can just select indoor
air);

(9) In the [CO2 Settings] menu, select a correct [Altitude]:05029. 2m, instrument default:0m;
mainly refer to the following table for its standard:

Air Pressure Conversion Table End-of-Respiration CO2 Data Read By Basing the Standard on
Altitude

Sea-Level Elevation Atmospheric Pressure 5%CO2


Inch m mmHg ETCO2 mmHg
Sea Level (0) Sea Level (0) 760 38
500 152. 4 745 37
750 228. 6 738 37
1, 000 304. 8 731 37
1, 500 457. 2 717 36
2, 000 609. 6 704 35
2, 500 762 690 35
3, 000 914. 9 677 34
3, 500 1066. 8 665 33
4, 000 1219. 2 652 33
4, 500 1371. 6 640 32
5, 000 1524 628 31
5, 500 1676. 4 616 31

- 92 -
6, 000 1828. 8 604 30
6, 500 1981. 2 593 30
7, 000 2133. 6 581 29
7, 500 2286 570 29
8, 000 2438. 4 560 28
8, 500 2590. 8 549 27
9, 000 2743. 2 539 27
10, 000 3048 518 26
10, 500 3200. 4 509 25
11, 000 3352. 8 499 25
11, 500 3505. 2 490 24
12, 000 3657. 6 480 24
12, 500 3810 471 24
13, 000 3962. 4 462 23
13, 500 4114. 8 454 23
14, 000 4267. 2 445 22
14, 500 4419. 6 437 22
15, 000 4572 428 21
15, 500 4724. 4 420 21
16, 000 4876. 8 412 21
16, 500 5029. 2 405 20
16, 800 5120. 6 400 20
Table 14-1

Note:It is assumed that the atmospheric pressure is 760mmHg and the ambient temperature is 0 at
the sea level. Calculation of Atmospheric Pressure:the sea-level based ambient temperature is assumed
as 0. Refer to the above Table.

Warning

By setting sea-level elevation, the monitor is not automatically changed with air pressure
compensations. Correct sea-level elevation must be set before the first use of CO2 Measurement
Program. Improper setting of sea-level elevation will result in incorrect CO2 readings. A 5%
CO2 deviation is generally generated corresponding to difference of each 1000m height.

(10) In the [CO2 Settings] menu, select a correct [Atmospheric Pressure]:405760mmHg, the
instrument default is 760 mmHg; when CO2 value is on the high side or on the low side, select an
appropriate atmospheric pressure based on the local condition by referring to the table above
- 93 -
(since the atmospheric pressure and the altitude are corresponding, the atmospheric pressure can
be adjusted only by setting the altitude. )

(11) In the [CO2 Settings] menu, select [Zeroing]; after zeroing, the following prompt is displayed at
the lower right corner of the screen:ZeroingPlease Wait for 30s; you can start measuring CO2
only after the prompt disappears.

14.6 Measuring Procedure of PHASEIN Branded Sidestream and

Mainstream Analyzers
The PHASEIN branded sidestream analyzer operating procedure is roughly the same as the
mainstream analyzer operating procedure; please refer to the sidestream analyzer operating procedure
for the mainstream analyzer operating procedure.

14.6.1 Measurement Steps

If you want to set the host monitoring equipment in order to start gas analysis, please execute the
following procedure:

a) Start the host monitoring equipment (if a minihost is used, please start the minihost monitoring
equipment at the same time).

b) Or insert the CO2 plug-in module into the host monitoring equipment; the indicator of the CO2
plug-in module will illuminate, which means that the module has been successfully connected to
the host monitoring equipment; otherwise, please reinsert the CO2 plug-in module.

c) Connect the Nomoline sampling tube to the input interface of the ISA analyzer (CO2 module)

d) Connect the interface cable of the ISA analyzer to the CO2 interface of the CO2 plug-in module
or the minihost.

e) Enter into the conventional screen of the host monitoring equipment, select [Exchange Waveform]
to call out the CO2 waveform and parameters which you want to monitor, such as [CO2] (this
step can be skipped if the screen has already displayed the CO2 waveform and parameters).

f) When the CO2 module is connected to the monitor, its module working mode is in the
Measurement state; however, in order to make sure that it is in the correct working state, please
do enter into the [CO2 Settings] menu to set its Working Mode to the [Measurement] mode.

g) Set [CO2 Switch] to [On].


- 94 -
h) Set appropriate [Oxygen Compensation], [Laughing Gas Compensation].

i) To connect the outlet of the sample gas to the discharge system, or to make the gas to flow back
to the patients circuit.

j) If it is green LED indication, ISA Analyzer is available.

k) To carry out inspection before use according to the statement in the check before use.

l) If the inspection is normal, start to monitor the Anaesthetic Gas.

14.6.2 Check before use

Before connecting the Nomoline sampling pipe to the breathing circuit, carry out the following steps:

a) Connect the sampling tube to the gas entrance interface (LEGI) of the ISA CO2 module.

b) Check whether the green light of LEGI is steadily on or notThe indication system is normal. .

c) Exhale to the sampling tube, check if a valid CO2 waveform and value are displayed on the host
monitoring equipment.

d) Use the finger tip to block up the sampling pipe, and hold on for 10 seconds.

e) Examine whether there is obstruction warning and if the LEGI shows a red flashing light.

f) Under proper circumstancesCarry out enclosure check on the patients circuit that is linked with
the sampling pipe.

Warning

Hang the external CO2 analyzer onto the CO2 bracket on the rear casing of the instrument;
prevent the dropping damage of the CO2 module.

Unless HME is used to protect the IRMA probe, the state indicating LED should face
upward all the time during IRMA probe placement.

Do not pull the cable of ISA Gas Analyzer.

Do not operate the ISA Gas Analyzer in the environment beyond the designated working
temperature.

Make sure all connections are firm and reliable. Any leakage will result in the inclusion of
ambient air in the patients respiratory gas, which leads to a wrong reading.

- 95 -
14.7 CO2 Settings in Parameter Area
Rotate the rotary shuttle button to move the cursor on the display interface to the CO2 hotkey in the
parameter area, and then press the rotary shuttle button to enter the menu CO2 Settings.

Figure 14-6 CO2 Settings

ALM ON/OFF(Alarm Switch): select On" to enable CO2 alarms, or select Off" to disable

CO2 alarms with the icon appearing beside CO2 in the parameter area on the screen.

ALM REC(Alarm Record): select On to enable the recorder output when there is any
CO2 alarm.
SWEEP(Alarm Speed): 12.5mm/s~25.0mm/s.
WAVE COLOR(Waveform Color): Green, Cyan, Red, Yellow, White, Blue, or Purple
Unit: mmHg/kpa.
CO2 ON(CO2 Switch): On or Off; select "On" to monitor the CO2.
O2 COMPEN(Oxygen Compensation): 0~100.(RESPIRONICS);HI,MED ,LOW
PHASEIN
N2O COMPEN:ON/OFF( This feature isonly available on PHASEIN )
BALAN GAS(Balance Gas): Indoor Air, Laughing Gas, or Helium. PHASEIN has not the
feature
ALTITUDE: 120~4920 mmHg (adjustable based on the geographical location).PHASEIN
has not the feature
BARO PRE(Atmospheric Pressure): 400~850 mmHg (adjustable based on the geographical
location: either Altitude or Atmospheric Pressure, not both). PHASEIN has not the feature
INS ALM HI(Upper Limit of INS Alarm): adjust the upper limit of INS alarm; if the

- 96 -
measured INS value exceeds the upper limit, there will be an alarm and prompting.
APNEA ALM(apnea alarm):No ,1s ,2s ,5s ,10s ,15s ,20s ,25s ,30s ,35s ,40s.
CO2 ALM SETUP:Used for to adjust CO2 the upper and lower limits of the range of the
high limit, middle limit and lower limit alarm . When the alarm limit CO2 measurement value
is greater than or less than the alarm limit, the instrument alarm and prompt.
AWRR ALM SETUP: Used for to adjust AWRR the upper and lower limits of the range of
the high limit, middle limit and lower limit alarm . When the alarm limit CO2 measurement
value is greater than or less than the alarm limit, the instrument alarm and prompt
ZERO CAL: zero before monitoring the CO2, in order to obtain a more accurate measured
value.
DEFAULT : override the original settings.

14.8 CO2 Settings in Waveform Area


Rotate the shuttle button to move the cursor on the display interface to the CO2 hotkey in the
waveform area, and then press the shuttle button to enter the menu CO2 Settings as below:

Figure 14-7 CO2 Settings

SWEEP: 12.5mm/s~25.0mm/s.
WAVE COLOR: Green, Cyan, Red, Yellow, White, Blue, or Purple.
WAVE TYPE: Line or Fill.

14.9 CO2 Settings in Measurement Setup


Select CO2 SETUP in the menu SURVEY SETUP " or rotate the shuttle button to move the cursor
to CO2 hotkey in the parameter area on the main screen, and then press the shuttle button to enter the
menu CO2 SETUP as below:

- 97 -
Figure 14-8 CO2 Settings

Note: Refer to the section CO2 Settings in Parameter Area for the specific options of the menu
CO2 Settings in Measurement Setup.

Warning
This monitor does not provide auto atmospheric pressure compensation. Please set a
correct altitude before the first use of the CO2 for measuring. Any wrong altitude could
result in an inaccurate CO2 reading: a reading error of 5% for each altitude deviation of
1000m.

14.10 Discharging Waste Gases


When nitrous oxide and/or an anesthetic gas is used, you should prevent these gases from polluting the
operating room. Usually the gas discharging outlet should be connected to (via the gas discharging
pipe connected to the sample gas outlet of the host equipment):

A discharging system (used for discharging collected gases) or the patient circuit (used for the back
flowing of collected gases).

Warning

Anesthetics:When an anesthetic which is being used or a patient who recently used an anesthetic
is measured, the gas discharging hole on the module must be connected to a waste gas processing
system or the patient circuit (on the anesthesia machine or the respirator), so as to prevent
medical personnel from inhaling the anesthetic.

- 98 -
14.11 Maintenance and Cleaning of RESPIRONICS Branded

Mainstream and Sdestream Modules

14.11.1 Common Cleaning

Clean with cloth, optionally dipped with 70% isopropanol, aqueous solution containing 10% sodium
hypochlorite (bleacher), sterilizing spray cleaner (such as Steris Coverage Spray HB), ammonia water
or mild soap water. Before cleaning, wash the cloth with rinse water and then wring out and air-dry the
washed cloth. Make sure that sensor windows are clean and are air-dried before being used repeatedly.

14.11.2 Airway Adapter for Cleaning Reusable Mainstream Sensor

Rinse it with warm soapy water first and soak it in liquid sterilizing fluid, such as 70% isopropanol,
aqueous solution containing 10% sodium hypochlorite (bleacher), 2. 4% glutaraldehyde solvent, e. g.
Cidex Plus or Steris System 1 or ammonia water. Wash it with clean water completely.

14.11.3 Method for Sterilizing Reusable Adapter

Autoclave Sterilizer-operable only to adult-used adapters.

Ethylene oxide (ETO)- Sterilizing for 1. 5h.

Soaking in Cidex Plus for 10h.

Soaking in Perasafe for 10h.

U. S. Steris System 1pasteurizer.

Before adapters are reused, please make sure that the windows are dried without any residuals and that
adapters stand intact during operation or cleaning/sterilization.

14.11.4 Sterilization Times for Reusable Airway Adapter

The reusable airway adapters can be reused 100 times if the above sterilization method is used.

14.11.5 Zeroing

Please zero before monitoring CO2; zeroing is to eliminate the effect of baseline drifting on the results

- 99 -
during measurement, thus ensuring the correctness of measured results.

Usually, the module will zero itself automatically when necessary. The user can zero the module
manually when the user considers it necessary:Select [CO2] in the parameter area, in the [CO2 Settings]
menu popping up, select [Zeroing] to zero the CO2 module. During zeroing, make sure that the patient
circuit is exposed to the ambient air (21% oxygen and 0% CO2) for approximately 30 seconds; when
the 30s zeroing prompt on the screen ends, it means zeroing is completed.

14.12 PHASEIN Branded Mainstream and Sidestream Analyzer

Related Information

14.12.1 Zeroing

An infrared gas analyzer needs to determine the zero reference level for CO2 measurement. This
zeroing standard is called as zeroing here.

Automatic Zeroing

(1) The ISA sidestream gas analyzer execute zeroing automatically by switching the gas sample from
the respiration circuit to the ambient air. To execute automatic zeroing once every 24 hours, the
ISA sidestream gas analyzer takes less than 3 seconds. If the ISA sidestream gas analyzer is
equipped with an oxygen sensor, automatic zeroing also includes the indoor air calibration of the
oxygen sensor.

(2) IRMA CO2 probes:

Zeroing needs to be performed ONLY when an offset in gas values is observed, or when an
unspecified accuracy message is displayed.
Allow 10 seconds for warm up of the IRMA CO2 probe after power on and after changing the IRMA
airway adapter before proceeding with the Zeroing Procedure. The green LED on the probe will be
blinking for approximately 5 seconds while zeroing is in progress.

Manual Zeroing

Select [CO2] in the parameter area, in the [CO2 Settings] menu popping up, select [Zeroing] to zero
the CO2 module. During zeroing, make sure that the patient circuit is exposed to the ambient air (21%
oxygen and 0% CO2) for approximately 30 seconds; when this menu is in a non default (settable)
condition, zeroing can be executed.

- 100 -
Warning

Since successful zeroing requires that the gas analyzer exists in the ambient air (21% oxygen
and 0% CO2), you should make sure that the ISA is placed at a well ventilated position. Before
and after executing the zeroing procedure, avoid breathing in the vicinity of the ISA sidestream
gas analyzer.

14.13 CO2 Module Lighting Information


Overview of States Indicated by LEGI:

Indicating Signal State


Not blinking green light The system is normal
Blinking green light Zeroing
Not blinking red light Sensor Error
Checking the sampling tube/airway
Blinking red light
adapter

14.14 Safety Alarm Information

14.14.1 ISA Sidestream Gas Analyzer Safety Warning Information

Warning
The ISA sidestream gas analyzer is designed to be used by authorized or trained medical
personnel.
Only Nomoline sampling tubes produced by PHASEIN can be used.
The ISA sidestream gas analyzer shall not be used in an inflammable anesthetic gas.
You should earnestly neaten the sampling tube in order to reduce the risk of it wrapping
or reining the patient.
Do not repeatedly use a disposable sampling tube.
Do not lift the ISA/host equipment by grasping the sampling tube; otherwise it may
break away from the ISA/host equipment, which may result in that the ISA/host
equipment falls onto the patient.
Used disposable sampling tubes should be disposed according to local medical waste
stipulations.
Do not use a sampling tube configured for an adult or a child on an infant; otherwise the

- 101 -
invalid cavity in the patient circuit will increase.
Do notuse a sampling tube configured for an infant on an adult; otherwise it will result in
a too big flowing resistance.
Do not use the ISA sidestream gas analyzer together with a quantitative spraying agent
or spray; otherwise it may result in the clogging of the germ filter.
Check if the flowing speed of the gas sample is too high for the given patient type.

Since successful zeroing requires that the gas analyzer exists in the ambient air (21%
oxygen and 0% CO2), you should make sure that the ISA is placed at a well ventilated
position. Before and after executing the zeroing procedure, avoid breathing in the
vicinity of the ISA sidestream gas analyzer.
The Nomoline sampling tube and its interface are not germ free devices. In order to
prevent the sampling tube from causing damages, please never carry out high pressure
sterilization on any part of the sampling tube.
Never disinfect the ISA sidestream gas analyzer or soak it into a liquid.
Mobile and radio frequency communication equipment will affect measurement. Make
sure that the ISA gas analyzer is used in the electromagnetic environment designated in
this operating instruction manual.
The ISA gas analyzer can only be used as a piece of auxiliary equipment for patent
evaluation. It must be used together with other vital sign and symptom evaluation
equipment.
If the input interface of the sampling tube starts showing red blinking, or a Nomoline
clogging message is displayed on the host, the sampling tube should be replaced.
It is not allowed to alter this equipment without the manufacturers authorization. If this
equipment is altered, appropriate checking and testing must be conducted in order to
make sure that it can be safely operated over a long period of time.
The ISA gas analyzer is not designed for being used in a MRI environment.
During MRI scanning, the host equipment must be placed outside the MRI room.
Using high frequency electrosurgical equipment in the vicinity of the ISA/host equipment
may produce interference, which will result into incorrect measurements.
Do not use the external natural heat dissipation function of the ISA equipment.
Do not apply a negative pressure (such as using a syringe) onto the Nomoline to remove
condensed water.
If the positive or negative pressure in the patient circuit is too high, it may affect the
samples flowing speed.
If the discharging or sucking pressure is too high, it may affect the samples flowing
speed.
The discharged gas should be discharged into the patient circuit, or into a discharging
system.
If the collected gas sample needs to supply air for respiration, a germ filter should be
used at the discharging side all the time.

- 102 -
When placing the ISA gas analyzer, try not to place it at a position where the analyzer
might fall onto the patient's body.

14.14.2 IRMA Mainstream Gas Analyzer Safety Warning Information

Warning
Do not use an IRMA airway adapter configured for an adult or a child on an infant,
since the adapter will add 6ml of invalid cavity to the patient circuit.
If the airway adapter has water drops/condensation, it should be replaced.
Use an IRMA airway adapter made by PHASEIN.
Do not use an IRMA infant airway adapter on an adult; otherwise it will result in a
too big flowing resistance.
When an energized part is contacted, sufficient protection should be provided to the
host equipment.
Only an adapter cable approved by PHASEIN AB can be used.
A warning must be implemented in the host equipment, displayed during
demonstrative data displaying.
The host equipment should be equipped with an appropriate alarm system to remind
the user of circumstances which may cause death or serious damages to the patients
health.
Every corresponding alarm message in IRMA state abstract fields must be
implemented in the host equipment.
The IRMA probe is not designed to be contactable to the patient.
Incorrect probe zeroing will result in false gas readings.

The IRMA probe is designed for being used by authorized or trained medical
personnel.
The IRMA probe is not designed shall not be used in an inflammable anesthetic gas.
A disposable IRMA airway adapter shall not be used repeatedly. Repeatedly using a
disposable adapter will cause cross infection.
Used disposable airway adapters should be disposed according to local medical waste
stipulations.
Only oxygen sensors made by PHASEIN can be used. Oxygen exhausted oxygen
sensors should be disposed according to local battery disposal stipulations.
Never try to open the oxygen sensor device. The oxygen sensor in the IRMA probe is a
disposable product, containing corrosive electrolytes and lead.
The IRMA probe is designed only as an auxiliary means for patient evaluation. It
must be used together with other vital sign and symptom evaluation equipment.
Never place the IRMA airway adapter somewhere between the trachea catheter and
the elbow; otherwise it may result in the adapter window being clogged by the
- 103 -
patients secretions and operating errors.
In order to prevent secretions and moisture from aggregating at the window and the
oxygen sensor port, always place the IRMA probe at a vertical position and let the
LED face upwards.
Never use the IRMA airway adapter together with a quantitative spraying agent or
spray; otherwise it may affect the light traveling of the airway adapter window.
If an IRMA OR (without the automatic anesthetic gas identification function) user
select a wrong anesthetic gas, it will result in false anesthetic gas readings.
If the IRMA OR (without the automatic anesthetic gas identification function) is
applied to a mixed gas containing several anesthetic gases, it will result in false
anesthetic gas readings.
Mobile and radio frequency communication equipment will affect measurement. You
should make sure that the IRMA probe is used in the electromagnetic environment
designated in this operating instruction manual.
Never disinfect the IRMA probe or soak it into a liquid.
The IRMA oxygen cell and the IRMA airway adapter are not germ free devices.
Never carry out high pressure sterilization on the equipment; otherwise it will result
in equipment damage.
Even if an IRMA probe has not been used, do not install an oxygen exhausted oxygen
cell on the probe.
Do not stretch the sensor cable.
Do not run this equipment beyond the temperature environment designated by this
operating instruction manual.
(USA): According to the federal law, this product can only be sold by doctors or based
on prescriptions.

14.15 Airway Obstruction


When the anesthetic gas airway is obstructed, on the screen there will be such a prompt message as
The anesthetic gas airway is obstructed; under such a circumstance, replace the Nomoline sampling
tube.

Warning
Do not use the ISA gas analyzer together with a quantitative spraying agent or
pulverization treatment; otherwise it may result in the clogging of the germ filter.

14.16 Discharging Waste Gases

- 104 -
When nitrous oxide and/or an anesthetic gas is used, you should prevent these gases from polluting the
operating room. Usually the gas discharging outlet should be connected to (via the gas discharging
pipe connected to the sample gas outlet of the host equipment):

A discharging system (used for discharging collected gases) or the patient circuit (used for the back
flowing of collected gases).

Warning
Anesthetics: When an anesthetic which is being used or a patient who recently used
an anesthetic is measured, the gas discharging hole on the module must be connected
to a waste gas processing system or the patient circuit (on the anesthesia machine or
the respirator), so as to prevent medical personnel from inhaling the anesthetic.

14.17 Consumables
The Nomoline sampling tube cannot be used repeatedly.

Replace the Nomoline sampling tube every two weeks or when The sampling tube is clogged is
displayed (based on whichever comes first).

14.17.1.1 Replacement of Nomoline and Nomoline Airway Adapter

Set

The Nomoline and Nomoline Airway Adapter Set are single-patient use products.
They should be replaced according to good clinical practice or when an occlusion message
appears. Occlusion occurs when the sample flow is too low. This is indicated by a flashing red
LEGI together with a message on the medical backboard device.

14.17.1.2 Replacement of Nomoline Adapter

The Nomoline Adapter is a multiple-patient use product.


The Nomoline Adapter should be replaced according to good clinical practice or when an
occlusion message appears. Occlusion occurs when the sample flow is too low. This is indicated
by a flashing red LEGI together with a message on the medical backboard device.
Replacement of T-adapter and Nomo Extension
The T-adapter and Nomo Extension are single-patient use products.
They should be replaced according to good clinical practice or when an occlusion message
appears. Occlusion occurs when the sample flow is too low. This is indicated by a flashing red
LEGI together with a message on the medical backboard device.

- 105 -
14.18 Safety Symbol Information

Symbol Title Explanation


Instructions for use
Consult instructions for use

Catalog number

Serial number

Batch code

Year of manufacture

Use by date [YYYY-MM-DD] The device should not be taken into operation
after the date accompanying the symbol.

Temperature limitation

Pressure limitation

Humidity limitation

Do not re-use Nomoline and Nomoline Airway Adapter Set


are intended for single patient use

Biohazardous waste Nomoline Family sampling lines shall be


disposed as biohazardous waste

For EU only: For EU only:


Waste Electrical and Electronic Electrical and electric equipment shall be
Equipment (WEEE) collected and recycled in accordance with
(Directive 2002/96/EC)

ETL Listing Mark Conforms to ANSI/AAMI 60601-1:2005 Cert.


to CAN/CSA-C22.2 No.60601.1:2008.

Conformit Europenne Complies with 93/42/EEC Medical Device


Directive when connected to medical devices
0413 approved by PHASEIN AB.

IP classification indicating level of Splash-proof


water protection

Rx only (US Only) Caution: Federal law restricts this


device to sale by or on the order of a licensed
healthcare practitioner.

CO2 ISA equipped to measure CO2 only

- 106 -
Sym
mbol Title
e Exp
planation
Multiigas (AX+ orr OR+) ISA equipped to measure mu
ultiple gases
s

Sigm
ma Multigas Technology
T The product is fittted with PHA
ASEIN Sigm
ma
Multtigas Technoology

Gas Inlet

Gas Outlet

Defibbrillation-proo
of type BF ap
pplied The applied partt of ISA is the
e Nomoline Family
F
part sam
mpling line

14.19 Paten
nts and Trrademark
ks
(1) Patent Statem
ment

PHASEIN AB
A owns thhe following patents for relevant products describbed in this operating
o
instruction manual: SE5519766; SE5519779; SE5
523461; SE5524086. Otheer patents are
a being
applied.

(2) Trademark

PHASEIN IRMA, PH
HASEIN ISA
A, PHASE
EIN XTP, Sigma Muultigas Techn
nology,
LEGI, N
Nomoline, IRMA E
EZ Integrato
or, PHASEIN GasM
Master an
nd ISA
MaintenanceeMaster arre trademarkss of PHASEIN
N AB.

Tygothane is a registerred trademarkk of Saint-Gob


bain Perform
mance Plasticss Corporation
n.

14.20 Mainttenance
The user should verify gas reeadings regullarly; If finding any probllem, please ccontact an engineer of
the manufacturer
m r for maintenaance.

14.21 Clean
ning the Analyzer
A
The Plug in annd measure ISA/IRMA gas analyzerr should be cleaned
c reguularly. Use etthanol or
isopropyl alcoholl with a maxiimum concenntration of 70%
% and a wet rag
r to clean the analyzer..

- 107 -
In order to prevent the cleaning liquid and dust from entering into the ISA gas analyzer from the LEGI
interface, the Nomoline sampling tube should be connected all the time during analyzer cleaning.

Before cleaning the IRMA probe, take off the disposable IRMA airway adapter.

Warning
The Nomoline sampling tube is not a germ free device. In order to prevent the
sampling tube from causing damages, please never carry out high pressure sterilization
on any part of the sampling tube.
Never sterilize the ISA sidestream gas analyzer and the IRMA probe or soak them into
a liquid.
The IRMA airway adapter are not germ free devices. Never carry out high pressure
sterilization on the equipment; otherwise it will result in equipment damage.

- 108 -
Chapter 15Neonates Awakening Function

15.1 Neonates Awakening Function


It awakens neonates with bradypnea caused by deep sleep or other reasons. The enabling of the
awakening function of the monitor depends on breathing frequency. The awakening device will wake
up neonates with vibration mode when the breathing frequency of neonates is lower than 7 bpm and
lasting time exceeds the limit set for asphyxia alarm; and it will stop working when breathing
frequency is above 7 bpm.

15.2 Connect Awakening Device


Place the awakening device at the sole centre of one foot of the neonate, and wind the bands around
the foot. DO NOT bond the band too loose as it may slip off which may disable its awakening
function; nor bond it too tight to avoid obstructed blood circulation and cause change in foot color, as
shown in the following figure:

Figure 15-1 Connect Awakening Device

Warning

Do not disinfect the awakening device or submerge it into liquid.


Do not pull the cables of awakening device.
Do not use the awakening device in a circumstance out of working temperature limit.
Do not apply the awakening device on an injured foot.
- 109 -
15.3 Application Precautions and Procedures
Insert the cable plug into WAKE socket on left side of the monitor.
Wind the band of awakening device at the sole centre of neonates foot, referring to 14.2 Awakening
Device Connection in this Chapter
Install ECG leads, referring to 9.3.2 Installing ECG Leads in C60 multi-parameter monitor manual.
Set asphyxias alarming time. Enter MEASURING SETTINGS and select RESP SETTINGS. Set
ASPHYXIA ALARMING as 10 to 40 seconds. It is advised not to set an excessively long time
Awakening device begin vibrating to wake up the neonates when the breathing frequency is lower
than 7 bpm, and lasting longer than the set asphyxia alarming time limit. The device stops after
neonates breathing frequency is over 7 bpm.

Warning

Following conditions must be met for normal working of awakening device under system
settings:
ALARMING SWITCH of RESP must be set as ON;
ASPHYXIA ALARM cannot be set as NON-ALARM.

15.4 Cleaning
Clean the awakening device under regular intervals with cloth dipped with ethanol or isopropanol with
maximum concentration at 70%.

Warning

Never disinfect the oxygen sensor or submerge it into liquid

- 110 -
Chapter 16OxygenConcentration Monitoring

16.1 About Oxygen Concentration


Oxygen is diffused into battery through the osmotic membrane of the oxygen sensor. There is a
sensing electrode (cathode) made of precious metals (gold or platinum etc.), and a working electrode
(anode) made of basic metals (lead or zinc etc.).. Both of the two electrodes are submerged into
electrolyte. Oxygen sensor is current generator, which needs no external power supply. Voltage which
is in direct ratio with oxygen concentration will be generated when a resistor is connected between the
anode and the cathode.

Chemical reaction occurs during measuring process, thus the batteries need to be replaced regularly
when the battery powers runs low (even before the equipment is used).

Oxygen concentration monitoring is mainly intended to prevent oxygen poisoning. Oxygen therapy is
a common treatment since some organs of premature and low weighted infants are immature. But high
oxygen concentration may cause side effects such as retinopathy of prematurity (ROP), lung hurt,
denitrified absorption atelectasis or other syndromes.

Currently in developed countries, as central oxygen supplying and compressed air are adopted, proper
oxygen therapy for neonates is realized through oxygen mixture of different concentrations using an
air mixer. Most of the developing countries are still directly applying pure oxygen therapy. Oxygen
concentration probe of the device will monitor the oxygen concentration and protect neonates from
oxygen poisoning for intaking oxygen of over high concentration.

Infants with premature lungs will survive well when put into 100% oxygen masks, while they often
suffer problems when they breathe 21% oxygen (concentration in the nature air) after leaving 100%
pure oxygen environment. For example, increased blood supplying and increased brain blood flow
may cause bleeding inside brain and on retinas, and lead to cerebral injury and blindness; and oxygen
poisoning is tend to happen for neonates, especially premature infants, after breathing 100% pure
oxygen in a long time.

16.2 Connecting Oxygen Sensors


- 111 -
Figure 16-1 Connecting Oxygen Sensor
1. Screw tight the top cover of the oxygen sensor probe clockwise.
2. Insert the connector into the oxygen sensor, with a click sound indicating that it is inserted
firmly.
3. Insert the cable plug of oxygen sensor into the O2 socket on left side of the monitor.

16.3 21% Calibration

1. Start the monitor;


2. Enter MAIN MENU of the monitor, and select MODULE SWITCH SETTINGS
inMONITOR SETTINGS, select O2 as ON.
3. Insert the cable plug of oxygen sensor into the O2 socket on left side of the monitor, referring to
15.2 Connecting Oxygen Sensor of in this Chapter.
4. Place the oxygen sensor in the air.
5. Enter O2 SETTINGS menu, and select 21% CALIBRATION. Choose YES in the
pop-updialogue box.
6. CALIBRATION SUCEEDappears in the prompt area of the instrument, if calibration succeeds
after 3 minutes; and recalibration is needed whenCALIBRATION FAILED prompt appears for
a failed calibration.

Attention

Make O2 calibration when oxygen concentration measuring error is oversized or when


replacing oxygen sensor.

Attention

O2 calibration must be made when there is no patient under monitoring.

Attention

Observe for relative technical fault alarm if calibration fails, and recalibrate after
eliminating the fault.

Attention
- 112 -
Replace the oxygen sensor and recalibrate it after repeated failure calibration, or contact
the equipment maintenance staff or our company if problems still exist.

Attention

Do not burn the oxygen sensor during disposal. Please follow relative regulations on
biological hazard.

16.4 100% Calibration


1. Ensure21% CALIBRATIONis made with success;
2. Place oxygen sensor into pure oxygen;
3. Select 100 % CALIBRATION in O2 SETTINGS menu, and choose YES in the pop-up
dialogue box;
4. CALIBRATION SUCEED appears in the prompt area of the instrument, if calibration succeeds
after 3 minutes; and recalibration is needed when CALIBRATION FAILED prompt appears for
a failed calibration.

Attention
Observe for relative technical fault alarm if 100 O2 calibration fails, and recalibrate it
after eliminating the fault.

Attention

Replace the oxygen sensor and repeat 21% O2 calibration after repeated failure
calibration, and then make 100% O2 calibration. Contact the equipment maintenance staff
or our company if problems still exist.

16.5 Alarm Settings


1. Enter O2 SETTINGS menu .
2. Set ALARMING SWITCH to ON.
3. Select O2 ALARM SETTINGS, and enter upper and lower limit short-cut keys of the High,
Middle, and Low alarms, and set proper upper/lower limit.

- 113 -
Figure 16-2 Set O2 Alarm

High Medium Low Steplength


O2 Upper (10100)% 8High upper 6 Medium 1%
limit limit-2% upper limit-2%
O2 Lower (0 medium 2Low lower 494% 1%
limit lower limit-2% down limit-2%

16.6 Oxygen Concentration Measure Procedures


1. Make pre-monitoring preparation referring to Connecting Oxygen Sensor, 21% Calibration, and
100 % Calibration above in this Chapter.
2. Set properly alarm switch, upper/lower alarm limit etc.
3. Put the oxygen sensor into the oxygen environment to be tested.
4. Read O2 concentration value indicated in the parameter area.

Warning

Place the oxygen sensor securely and firmly to avoid injury or damage from dropping.
Do not stretch the oxygen sensor cable
Do not operate the oxygen sensor out of designated working temperature environment.

16.7 Cleaning

Clean the oxygen sensor regularly with cloth dipped with ethanol or isopropanol with maximum

- 114 -
concentration at 70%.
Keep the crystal plug connected when the cleaning oxygen sensor to prevent the cleaning liquid or
dust from entering the device via the port, and avoid liquid around the plug.

Warning

Do not disinfect or submerge the oxygen sensor.

- 115 -
Chapter 17IBP Monitoring

17.1 General information


This chapter mainly introduces invasive blood pressure (IBP) monitoring methods and contents
relevant to maintenance and cleaning of accessories.
STAR8000H portable-type multi-parameter monitor can be directly used for measuring vascular
pressures (diastolic pressure, systolic pressure and mean blood pressure). The following waveforms
can be displayed:

Waveform Name Definition

ART arterial pressure

PA pulmonary arterial pressure

CVP central venous pressure

RAP right atrial pressure

LAP left atrial pressure

ICP intracranial pressure

Remark: IBP monitoring part is an optional component.

17.2 Considerations of IBP monitoring

Warning

The chosen accessory, if applied, should confirm to safety requirements of medical


equipment.

Warning

In connection and application, accessories should be avoided from contacting metal parts
connected with electric apparatus.

Warning

Users, when connecting the monitor with a high-frequency surgical instrument, should
avoid the sensor and cable of the monitor from contacting the high-frequency surgical
instrument so as to prevent patients from being burnt in case of electricity leakage.

- 116 -
Warning

The disposable pressure sensor should not be reused.

Caution

Only the pressure sensor specified in the Manual can be used.


The specified sensor has shock-proof function (with resistance to leakage current) and can prevent
influence of cardiac defivrillators. It can be used in surgeries. When the patient is in the defibrillation
period, the pressure wave may exhibit temporary disorders; but after defibrillation, the monitor will
work normally and the operation mode and user configuration of it wont be affected.

Warning

Before monitoring, the sensor should be examined for normality assurance. If the sensor is
pulled out of the jack, an error-warning message, IBP sensor detached, will appear on the
screen and alarm sounds will be sent out.

Caution

Sensors, new or used, should be regularly calibrated according to hospital practice.

Warning

If liquid (not solution applied to the pressure pipe and the sensor) is splashed on the
instrument or accessories, especially when the liquid may enter the sensor or the monitor,
place contact with the maintenance department of your hospital.

17.3 Monitoring procedure


Measurement preparation:
Insert cables into corresponding sockets and check to ensure the monitor has been plugged in.
Have the pressure pipe and the sensor prepared. Fill the system full with physiological saline solution
to make sure no bubble exists therein.
Connect the patient catheter to the pressure pipe and make sure that there is no air in the catheter and
the pressure pipe or the sensor.

Warning

If bubbles are found in the pressure pipe or the sensor, flush the system with the perfusion
liquid.
Position the sensor on the same level as the heart, approximately on the midaxiallary line
Confirm correct ruler names have been chosen. See the following section for details.
Do zero-adjustment of the sensor. See the following section for details.

- 117 -
Figure 17-1 IBP Monitoring

17.4 IBP Menu


Select the Module Setup option in the monitor setup menu and set the CO2 on-off to be on. The
following figure (the present figure is in demonstrating mode) will come out:
Rotate the knob and move the cursor to the IBP hotkey in the parameter area of the screen.
Press the knob to enter the IBP selection menu.

17.4.1 IBP<1,2>setup in the parameter area

Rotate the knob and move the cursor to the IBP hotkey in the parameter area of the screen.

- 118 -
Fig 17-2 IBP Parameter Setting Menu

Settings can be done on the following items:


ALM ON/OFF(Alarm switch): Where ON is selected, the alarm prompt and saving
will proceed when the IBP (invasive blood pressure) is alarmed; where OFF is
selected, alarming will not happen, but will be prompted beside IBP in the screen
parameter area.
ALM LEV(Alarmlevels): Optional levels are High, Middle and Low.
ALM REC(Alarm record): select On to enable the recorder output when there is any
IBP alarm.
ALARM SETUP: When the alarm measurement value is greater than or less than the
alarm limit, the instrument alarm and prompt.
CH1: ART, PA, CVP, RAP, LAP ,LAP ,ICP ,P1,P2 limit Hi setup:
SYS: UpperSYS alarm limit: used for setting the upper alarm limit
MEA: Upper MEA alarm limit:used for setting the upper alarm limit
DIA: Upper DIA alarm limit: used for setting the upper alarm limit
CH1: ART, PA, CVP, RAP, LAP ,LAP ,ICP ,P1,P2 limit Lo setup:
SYS: LowerSYS alarm limit: used for setting the lower alarm limit
MEA: Lower MEA alarm limit:used for setting the lower alarm limit
DIA: Lower DIA alarm limit: used for setting the lower alarm limit
CH2: ART, PA, CVP, RAP, LAP ,LAP ,ICP ,P1,P2 limit Hi setup:
SYS: UpperSYS alarm limit: used for setting the upper alarm limit
MEA: Upper MEA alarm limit:used for setting the upper alarm limit
DIA: Upper DIA alarm limit: used for setting the upper alarm limit
CH2: ART, PA, CVP, RAP, LAP ,LAP ,ICP ,P1,P2 limit Lo setup:
- 119 -
SYS: LowerSYS alarm limit: used for setting the lower alarm limit
MEA: Lower MEA alarm limit:used for setting the lower alarm limit
DIA: Lower DIA alarm limit: used for setting the lower alarm limit

Caution

Users should guarantee that zero calibration has been done on the sensor before the
measurement; otherwise the instrument has no effective zero value, which may lead to
inaccuracy of measured data.
Once the measured data exceed the alarm limits, the alarm will be triggered.

IBP alarm limits:

Adjustable
Pressure Scale Name Max Upper Limit Min Lower Limit
Single-Step Length
(mmHg) (mmHg)
mmHg
ART 300 0 1
PA 120 -6 1
CVP 40 -10 1
RAP 40 -10 1
LAP 40 -10 1
ICP 40 -10 1
SCALE AGJUST : The IBP waveform area provides scales for waveforms. Two dash
line of each IBP waveform, from the upper to the lower, respectively represents the
upper-limit scale and the lower-limit scale of the waveform. Values of the two scales
may be set. The detailed setting method is introduced in the current menu.
CH1:ATR ,PA ,CVP ,RAP ,LAP ,ICP ,P1 ,P2 Setup:
Upper scale: The pressure value represented by the upper scale limit. The
choice range is the measurement range of the current pressure.
Lower scale: The pressure value represented by the lower scale limit. The
choice range is the measurement range of the current pressure.
Mean scale: he pressure value represented by the middle scale limit. The choice
range is the measurement range of the current pressure.
CH2:ATR ,PA ,CVP ,RAP ,LAP ,ICP ,P1 ,P2 Setup:
Upper scale: The pressure value represented by the upper scale limit. The
choice range is the measurement range of the current pressure.
Lower scale: The pressure value represented by the lower scale limit. The
choice range is the measurement range of the current pressure.
Mean scale: he pressure value represented by the middle scale limit. The choice
range is the measurement range of the current pressure.

Caution
- 120 -
The upper scale limit value should not be lower than the lower limit value.

Caution

The lower scale limit value should not be higher than the upper limit value.

Caution

The lower pressure limit, the upper pressure limit, the reference scale and the waveform are
displayed simultaneously on the screen so that users can observe waveform changes after
the scales are adjusted.

CH1/CH2 ZERO: the IBP1 and IBP2 module into the socket, the need for invasive
pressure zeroing.

17.4.2 IBP<1,2>setup in the waveform area

Rotate the knob and move the cursor to the IBP hotkey in the waveform area of the screen.

Figure 17-3 IBP Parameter Setting Menu

Settings can be done on the following items:


CH Press Setup:eight options including ART, PA, CVP, RAP, LAP,ICP ,P1 and P2 are
provided.

SWEEP:12.5mm/s,25mm/s

FILTER: smooth, normal ,no filter

WAVE COLOR:green ,cyan , red ,yellow ,white ,blue , purple

WAVE TYPE:line,fill

- 121 -
17.4.3 IBP<1,2>setup in the measurement setup

Select the Module Setup option in the monitor setup menu and set the CO2 on-off to be on. The
following figure (the present figure is in demonstrating mode) will come out:
Press the knob to enter the IBP selection menu.

Figure 17-4 IBP Parameter Setting Menu

Settings can be done on the following items:


IBP<1,2>SETUP:
ALM ON/OFF: see this chapter parameter area IBP <1,2>setup the ALM ON/OFF.
ALM LEV: see this chapter parameter area IBP <1,2>setup the ALM LEV
ALM REC: see this chapter parameter area IBP <1,2>setup the ALM REC
SWEEP: see this chapter waveform area IBP <1,2>setup the SWEEP
WAVE COLOR: see this chapter waveform area IBP <1,2>setup the WAVE COLOR.
UNIT : mmHg,kPa,cmH2O
FILTER: see this chapter waveform area IBP <1,2>setup the FILTER.
CH Press Setup: see this chapter waceform area IBP <1,2>setup the CH Press Setup
ALARM SETUP: see this chapter parameter area IBP <1,2>setup the ALARM SETUP
SCALE AGJUST see this chapter parameter area IBP <1,2>setup the SCALE AGJUST
DEFAULT: checked into the IBP <1,2> Default Settings dialog box, select "No" to
abandon the current operation, the system remains the original configuration
unchanged, select "Yes", and will be using the default settings,the original
configuration will be overwritten.
IBP PRESSURE ZERO
CH1 ZERO: the IBP1 and IBP2 module into the socket, the need for invasive pressure
zeroing.
CH2 ZERO: the IBP1 and IBP2 module into the socket, the need for invasive pressure

- 122 -
zeroing.
CAL(calibration)
CH1 CAL VALUE:Adjustable from 80 to 300 values.
CH2 CAL VALUE: Adjustable from 80 to 300 values.
CH1 ADJUST
CH2 ADJUST

Warning

When setting alarm limits, users should confirm the item to be set.

Caution

Users should guarantee that zero calibration has been done on the sensor before the
measurement; otherwise the instrument has no effective zero value, which may lead to
inaccuracy of measured data.
Once the measured data exceed the alarm limits, the alarm will be triggered.

IBP alarm limits:

Adjustable
Pressure Scale Name Max Upper Limit Min Lower Limit
Single-Step Length
(mmHg) (mmHg)
mmHg
ART 300 0 1
PA 120 -6 1
CVP 40 -10 1
RAP 40 -10 1
LAP 40 -10 1
ICP 40 -10 1

17.4.3.1 Zero calibration of sensor:

Press the IBP zero calibration key with the rotary knob and the system will begin zero calibration.
Zero calibration consideration:
Before zero calibration, close the three-way stop cock at the patient side.
Before zero calibration, the sensor should communicate with the atmosphere.
The sensor must be positioned at the same level with the heart, approximately on the
midaxillary line.
Zero calibration should be done before monitoring start and at lease once per day (zero
calibration must be done each time after the cable is plugged or pulled.)

- 123 -
blood pressure gauge

Figure17-5 Connection layout of IBP pressure calibration

Calibration of the mercury manometer should be done when a new sensor is being started to
use or at the specified cycle in the hospital practice.
The purpose of calibration is to ensure the system to provide accurate measured results.
Before calibration of the mercury manometer, pressure zero calibration should be done.
If the procedure is to be carried out by yourself, you should have the following devices.
standard blood pressure gauge
three-way stop cock
pipeline with a length of about 25cm

17.4.3.2 Mercury manometer calibration procedures:

Warning

The following operation should never be done when a patient is being monitored.

Close the three-way stop cock which is opened to the atmosphere for zero calibration.
Connect the pipeline with the blood pressure gauge.
Confirm that connection to the patient has been off.
Connect a three-way stop cock with the three-way joint that hasnt been connected to the patient
catheter (when the patient is being monitored). Connect a syringe to one end of the three-way stop
cock and connect the blood pressure gauge and the pipeline with the other end.
Open the end open to the blood pressure gauge.
Select the channel to be calibrated in the pressure calibration menu and adjust the pressure values of
the channel to be calibrated.
Charge gas to raise the scale of the mercury column to the set pressure value in the menu.

- 124 -
Repeatedly adjust until values in the menu equal to pressure values in the blood pressure gauge.
Press once the calibration button in the calibration menu to command the instrument to begin
calibration.
Wait until the calibration ends. Make corresponding countermeasures to be taken according to prompt
information.
Detach the pipeline of the blood pressure gauge and the added three-way stop cock after completion of
the calibration.
The IBP waveform area provides scales for waveforms. Two dash line of each IBP waveform, from
the upper to the lower, respectively represents the upper-limit scale and the lower-limit scale of the
waveform. Values of the two scales may be set. The detailed setting method is introduced in the
current menu.
IBP pressure scale name: ART, RA, CVP, RAP, LAP and ICP are available for selection in the hotkey
area of the IBP menu;
Upper scale: The pressure value represented by the upper scale limit. The choice range is the
measurement range of the current pressure.

Caution
The upper scale limit value should not be lower than the lower limit value.
Lower scale: The pressure value represented by the lower scale limit. The choice range is the
measurement range of the current pressure.

Caution
The lower scale limit value should not be higher than the upper limit value.

Caution
The lower pressure limit, the upper pressure limit, the reference scale and the waveform are
displayed simultaneously on the screen so that users can observe waveform changes after the
scales are adjusted.

17.5 Alarm information and prompt information

17.5.1.1 Alarm information


When alarm record switches in related menus are turned on, physiological alarms given when
parameters exceeds alarm limits will trigger the recorder to automatically output alarmed parameters
and related measured waveforms.
Possible physiological alarms, technical alarms and prompt messages in IBP module measurement are
listed in the following tables:

Physiological alarms

PROMPT CAUSE ALARM


MESSAGE LEVEL
- 125 -
IS too high Measured SP value is higher than the set upper alarm User Optional
limit.
IS too low Measured SP value is lower than the set lower alarm User Optional
limit.
ID too high Measured DP value is higher than the set upper alarm User Optional
limit.
ID too low Measured DP value is lower than the set lower alarm User Optional
limit.
IM too high Measured MP value is higher than the set upper alarm User Optional
limit.
IM too low Measured MP value is lower than the set lower alarm User Optional
limit.

Technical alarms:

PROMPT CAUSE ALARM SOLUTION


MESSAGE LEVEL
IBP lead detached IBP cable is Low Make sure the cable is connected
detached from the reliably.
monitor
IBP measurement High Suspend the IBP measurement function
IBP module
module has faults and inform biomedical engineers or
initialization wrong
maintenance workers.

17.6 Maintenance and Cleaning

Warning

Please turn off the monitor and disconnect the AC power supply before cleaning the
monitor or sensor.
When the operations of pressure monitor is finished, please remove the airway and cap from the
sensor and clean the film of the sensor with water. You can use the soapy solution or any of the
following detergents to clean the sensor and cable.
Cetylcide
Wavicide-01
Wescodyne
Glutaraldehyde
Lysol
Vesphene
Do not immerse the connector in any liquid. After cleaning, do not put it away until the sensor is
completely dry. It is normal that the cable fades slightly or has a stronger adhesiveness on the surface.
If it is necessary to remove the residue of adhesive tape from the sensor, please use the double-sided
adhesive scavenger. Be careful to use the cable, in order to minimize the damage. Please do not use
such strong solvents as acetone, alcohol, ammonia water or chloroform, as they could damage the

- 126 -
vinyl cable as time goes on.

Caution

No one-off sensor or cap is allowed to be re-disinfected or reused.

Caution

For the purpose of environmental protection, please recycle or dispose of the one-off sensor
or cap in a proper way.
Disinfection
Disinfection by Chemical Liquid
Follow the above steps to remove the visible dirt. Select an effective chemical disinfectant applicable
to the equipments in the operation room, like buffered glutaraldehyde (glutaraldehyde or preservative).
Do not use any quadrivalent cationic detergent, like benzalkonium chloride. To disinfect the whole
instrument, please remove the cap, immerse the sensor (except the electrical connector) in the
disinfectant for the recommended time, and then use the sterile water or physiological saline to rinse
out all components (except the electrical connector) of the sensor. Do not put the sensor away until it
is completely dry.
Disinfection by Gas
For a complete sterility, a gas disinfectant is necessary:
Follow the above steps to remove the visible dirt. In order to restrict the ethylene glycol,
please make sure the sensor is completely dry when you use the ethylene oxide gas disinfectant.
Please follow the operating instructions provided by the manufacturer of the gas
disinfectant.

Warning

The disinfectant temperature should not be higher than 70(150), or the plastics inside
the pressure sensor could deform or melt.

- 127 -
Appendix I Accessories
Standard accessories

No Code Name Quantity

1 040-000073-00 electrodes 1 bag


2 040-000317-00 Patient cable 1pc.
3 040-000204-00 Blood pressure extension cord 1pc.

4 040-000361-00 Reusable blood oxygen probe 1pc.

5 040-000362-00 Reusable blood oxygen probe sponge bind belt 4pc.

6 040-000006-00 Handwritten pen 1pc.

7 040-000148-00 Ground cord 1pc.

8 040-000323-00 one-time sleeve 1# 1pc.

9 040-000324-00 one-time sleeve 2# 1pc.

10 040-000325-00 one-time sleeve 3# 1pc.

11 040-000326-00 one-time sleeve 4# 1pc.

12 040-000328-00 Blood pressure catheter 1pc.

13 009-000074-00 power cord 1pc.

14 022-000043-00 Lithium battery 1pc.

15 115-000163-00 ECG cable 1pc.

Optional accessories

No Code Name Quantity

1 040-000007-00 Recording paper 1roll

2 040-000022-00 A single patient use neonatal airway adapter 1pc.

3 040-000023-00 Cable fixed card slot 1pc.

4 099-000004-00 LOFLOSide stream CO2 module/sensor 1pc.

5 040-000024-00 Side current way adapter (with desiccant tube) 1pc.

6 040-000025-00 Side stream module clamp 1pc.

7 040-000216-00 IRMA airway adapter 1pc.

8 040-000193-00 CO2 module extension cord 1pc.

9 040-000017-00 ISA NOMOLINE sampling tube 1pc.

10 040-000193-00 CO2 module extension cord 1pc.

- 128 -
11 115-000102-00 Neonates asphyxia awakening device 1pc.

12 040-000199-00 Blue band 1pc.

13 040-000196-00 Oxygen battery 1pc.

14 009-000503-00 Oxygen sensor cable 1pc.

- 129 -
Appendix IIProduct Specifications
Classification
Anti- electric-shock type: Class I equipment with the external power supply, anti-defibrillation
equipment with internal power supply, continuously operating equipment;
Anti-electroshock degree: equipment belonging to application part of BF, CF Type(among
which,ECG testingpart belongs to CF-based application, remaining all othertesting parts belong to
BFtype application parts);
Harmful Ingress of Water proof degree: Ordinary equipment (sealed equipment without liquid proof)
Duty: continuous work
EMC type A level

Product specification
Size and weight
Size: 245.5mm220mm110mm
Weight:about 3kg
Power environment
Rated Voltagea.c.100V~250V
Rated Frequency50Hz/60Hz
Built-in Battery12VRechargeable Lithium Battery
Power SupplyBuilt-in Rechargeable Batteryor external power supply
Rated Power40VA~60VA
Resolution 800600
Transportation and Storage
Transport: Must avoid severe shock ,vibration, rain and snow during transport
Storage : Packed monitors must be stored in well ventilated rooms with -10+40 temperature,
relative humidity no more than 80%, and without corrosive gases

Normal Operation
a) Temperature540
b) Relative Humidity80%
c) Atmospheric pressure86kPa106kPa
LCD specification:
Dispiay 8.4 color TFT
Display information6 channels waveform display
Record ( optional )
Record Width 48 (mm)
Paper Speed 25/50 (mm/S)
Trace 2
Recording types: 3s,5s,8s,continuous
ECG
Lead Mode 5 Leads ( R,L,F,N,C or RA,LA,LL,RL,V)
Lead selection I, II, III, avR, avL, avF, V, and MCL for calibration
- 130 -
Lead mode 3 Leads (R, L, F or RA,LA,LL)
Lead selection I, II, III
Gain 2.5mm/mv , 5 mm/mv , 10 mm/mv , 20 mm/mv , auto
HR Range neonate15 ~ 350 (bpm)
Accuracy 1% or 1bpmboth maximum
Input Impedance > 5 (M)
CMRR > 105 (dB)
Cardiac Electrophysiology Noise level30VP-P.
Cardiac Electrophysiology Input loop current0.1A
Time constantMonitoring, surgical mode: 0.3s;
Diagnosis mode: 3.2s.
Heart rate alarm occurring time 12s
cardiac electrophysiology channel bandwidth Monitoring mode: 0.540Hz;
Diagnostic mode: 0.05130Hz;
Surgical mode: 120Hz.
RESP
Method Impedance between RA-LL
Measuring Range
neonate 7 ~ 150 (bpm)
Alarm range
neonate upper limit 9~ 150 (bpm)
lower limit 6~148(bpm)
Resolution 1 (bpm)
Accuracy 2 (bpm) or 2% both maximum
Apean Alarm 10 ~ 40 (S),no alarm
NIBP
Method AutomaticOscillometric
Mode Manual, Auto, Continuous
Measuring Interval in AUTO Mode
1 ~ 480 (Min)
Pulse Rate Range 20-300 (bpm)
Type SYS, DIA, MEAN
Measuring Range
Neonatal Mode
SYS 40~150 (mmHg)
DIA 10~100 (mmHg)
MEAN 20~110 (mmHg)
Accuracy 5mmHg
Overpressure Protection
Pediatric Mode 240 (mmHg)
Neonatal Mode 150 (mmHg)
Alarm limit
Neonatal Mode
SYS Upper limit42 ~ 135 (mmHg)
Lower limit40 ~ 133 (mmHg)
- 131 -
DIA Upper limit 10 ~ 110 (mmHg)
Lower limit15 ~ 235 (mmHg)
MEAN Upper limit 15 ~ 125 (mmHg)
Lower limit15 ~ 235 (mmHg)
NIBP Measurement review 2000

SPO2
Measuring Range 0 ~ 100 %
Resolution 1%
Accuracy 70% ~ 90% (2%)
90% ~ 100%(1%)
Alarm range upper limit 1% ~ 100%
` lower limit 0% ~ 99%
Accuracy1%
Pulse Rate
Measuring and Alarm Range 20~300bpm
Resolution 1bpm
Accuracy 1bpm

TEMP
Measuring and Alarm Range 0 ~ 50 C
Resolution 0.1C
Accuracy 0.1C
Alarm range upper limit 0.1 ~ 50 C
lower limit 0 ~ 49.9C
CO2
CO2 Measurement Range: 0 -150 mm Hg, 0 to 79%, 0 to 20kPa (at 760mmHg)
Accuracy: 2 mm Hg (0 40 mm Hg)
5% of reading (41 70 mm Hg)
8% of reading (71 100 mm Hg)
10% of reading (101 150 mm Hg)
Setting range and error of alarm 0 mmHg150mmHg or 0 kPa20kPa (at 760mmHg)
Error 0.1kPa or1mmHg
IBP 1/2
Channel 1/2 pressure ARTPACVPLAPICPRAPP1P2
Measurement unit mmHgKPa
ART 0~300 mmHg
PA -6~120 mmHg
CVP -10~40 mmHg
RAP -10~40 mmHg
LAP -10~40 mmHg
ICP -10~40 mmHg
P1- P2 -10~300 mmHg
Resistance range: 300~3000

- 132 -
Oxygen Sensor Specifications

Output Output 9-13 mV on 210hPa O2


Range 01500hPa O2
100% O2 signal bias 1001%
100% O2 measuring bias 0-1003%ss
Resolution 1hPa O2
1.5106 % measured at 20C
Expected service life 0.8106 % measured at 40C
Response Time (21% air to 100% oxygen) < 15s
app:ds:linearity 0-100% O2
Working temperature -20C+50C
Temperature compensation 0-40C with 2% fluctuation
Pressure range 50200KPa
Relative humidity 0 99%
100% oxygen concentration output shift Typical value over 1 year <5%
Material White ABS
Package Sealed package

Validity period after unpacking is no more than 13


months (under manufacturer-specified conditions,
Expiration otherwise validity period differs)

- 133 -
AppendixIIIInstruction to System Alarm
Prompts
Physical Alarms:

Prompting
Causes Alarm Grade Corrections
Information
Check whether alarming
O2 concentration O2 concentration is higher than
Optional limits fit for patients
too high set alarming upper limit
current conditions
O2 concentration O2 concentration is lower than
Optional
too low set alarming lower limit

Technical Alarms:

Prompting
Cause Alarm Grade Corrections
Information

O2 module Cable of oxygen sensor Reinsert O2 module and ensure


Low
disconnected disconnected with monitor a reliable cable connection

21% O2
21% O2 concentration
concentration Low Wait for calibration result
calibration is going on
calibrating

100% O2
100% O2 concentration
concentration Low Wait for calibration result
calibration is going on
calibrating

Prompts:

Prompts Causes Alarm Grade Corrections


- 134 -
21% O2 concentration
calibration succeeded Calibration succeed Low None

ss100% O2 concentration
calibration succeeded Calibration succeed Low None

- 135 -
Appendix IVGuidance and Manufacturers
Declaration

Guidance and manufacturers declaration

Guidance and manufacturers declaration electromagnetic emissions The C60 is


intended for use in the electromagnetic environment specified below. The customer or the user of the C60
should assure that it is used in such an environment.

Emissions test Compliance Electromagnetic environment guidance

RF emissions CISPR Group 1 The C60 uses RF energy only for its internal function.
11 Therefore, its RF emissions are very low and are not
likely to cause any interference in nearby electronic
equipment.
RF emissions CISPR Class A
11
Harmonic emissions Class A
IEC 61000-3-2

Voltage Complies
fluctuations/flicke r
emissions IEC
61000-3-3

Guidance and manufacturers declaration electromagnetic immunity


The C60 is intended for use in the electromagnetic environment specified below. The customer or the user of
the C60 should assure that it is used in such an environment.
Immunity IEC 60601 test Compliance Electromagnetic environment
test level level guidance

Electrostatic 6 kV contact 8 4kV Contact Floors should be wood, concrete or


discharge kV air 8kV Air ceramic tile. If floors are covered with
(ESD) IEC synthetic material, the relative humidity
61000-4-2 should be at least 30 %. If ESD interfere
with the operation of equipment, counter
measurements such as wrist strap,
grounding shall be considered.

Electrical fast 2 kV for power 2 kV for Power Mains power quality should be that of a
transient/burst supply lines 1 kV supply lines typical commercial or hospital
IEC 61000-4-4 for input/output environment.
lines

- 136 -
Surge IEC Mains power quality should be that of a
61000-4-5 1 kV differential 1kV differential typical commercial or hospital
mode 2 kV mode 2kV environment.
common mode common mode
Voltage dips, <5 % UT (>95 % <5% UT for 0.5 Mains power quality should be that of a
short dip in UT) for 0,5 cycle 40% UT for typical commercial or hospital
interruptions cycle 40 % UT 5 cycles 70% UT environment. If the user of the C60
and voltage (60 % dip in UT) for 25 cycles <5% requires continued operation during
variations on for 5 cycles 70 % UT for 5 s power mains interruptions, it is
power supply UT (30 % dip in recommended that the C60 be powered
input lines IEC UT) for 25 cycles from an uninterruptible power supply or a
61000-4-11 <5 % UT (>95 % battery.
dip in UT) for 5
sec

Power 3 A/m 3 A/m Power frequency magnetic fields should


frequency be at levels characteristic of a typical
(50/60 Hz) location in a typical commercial or
magnetic field hospital environment.
IEC 61000-4-8

Guidance And ManufacturerS Declaration Electromagnetic Immunity for


equipment and systems that are not life-supporting

Guidance and manufacturers declaration electromagnetic immunity The C60 is


intended for use in the electromagnetic environment specified below. The customer or the user of the C60
should assure that it is used in such an environment.
Immunity IEC 60601 test Compliance Electromagnetic environment
test level level guidance

- 137 -
Conducted RF 3 Vrms 3V Portable and mobile RF communications
IEC 61000-4-6 150 kHz to 80 equipment should be used no closer to any
MHz part of the C60, including cables, than the
recommended separation distance calculated
from the equation applicable to the
Radiated RF 3V/m frequency of the transmitter. Recommended
IEC 61000-4-3 3 V/m separation distance d = 1.2 p d = 1.2 p 80
80 MHz to 2,5 MHz to 800 MHz d = 2.3 p 800 MHz to 2,5
GHz GHz where P is the maximum output power
rating of the transmitter in watts (W)
according to the transmitter manufacturer
and d is the recommended separation
distance in metres (m). Field strengths from
fixed RF transmitters, as determined by an
electromagnetic site survey, should be less
than the compliance level in each frequency
range. Interference may occur in the vicinity
of equipment marked with the following
symbol:

Recommended separation distances between portable and mobile RF


communications equipment and the EQUIPMENT or SYSTEM For
EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING
Recommended separation distances between Portable and mobile RF
communications equipment and the C60
The C60 is intended for use in an electromagnetic environment in which radiated RF disturbances
are controlled. The customer or the user of the C60 can help prevent electromagnetic interference
by maintaining a minimum distance between portable and mobile RF communications equipment
(transmitters) and the C60 as recommended below, according to the maximum output power of the
communications equipment.
Rated maximum Separation distance according to frequency of transmitter m
output power of
transmitter W

150 kHz to 80 MHz d 80 MHz to 800 MHz 800 MHz to 2.5 GHz d
= 1.2 p d = 1.2 p = 2.3 p
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23

- 138 -
For transmitters rated at a maximum output power not listed above, the recommended separation
distance d in meters (m) can be estimated using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter in watts (W) according
to the transmitter manufacturer. NOTE 1 At 80 MHz and 800 MHz, the separation distance for 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.

- 139 -
Shenzhen Comen Medical Instrument Co., Ltd.
South of Floor 7, Block 5 & Floor 6, Block4 , 4th Industrial Area of Nanyou,
Nanshan District, Shenzhen, Guangdong, P.R. China
Tel: +86-755-26408879Fax: +86-755-26401232 Http://www.szcomen.com

Lotus Medical Equipment Limited


Add: 26B Cameron Court, Cork Street, Dublin 8, Ireland
Tel: +00353-1-6571034 Email: [email protected]

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