OMNI EXPRESS PATIENT MONITOR
OPERATOR’S MANUAL
PortabPortab
Copyright
INFINIUM MEDICAL, INC. owns all right to this unpublished work and intends to maintain this work as confidential copyright. This publication is to be used solely for the purpose of reference, operation, maintenance, or repair INFINIUM equipment. No part of this can be disseminated for other purposes.
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Content of the manual is subject to changes without prior notice.
Content
Chapter 1 Introduction 4
1.1 Profile 4
1.2 Safety Information 4
1.3 Explanation of Symbols 5
Chapter 2 Overview of the Monitor 7
2.1 Appearance of Monitor 7
2.2 Special Features 9
2.3 Specification 10
Chapter 3 Menu Instruction 13
3.1 Display Screen 13 3.2 Menu Operation 14 3.2.1System Menu 14 3.2.2 Trend Table 18 3.2.3 Alarm Setup 23 3.2.4 Silence 23 3.2.5 ECG Setup 24 3.2.6 NIBP Setup 25 3.2.7 SPO2 Setup 25 3.2.8 RESP Setup 26 3.2.9 TEMP Setup 27 3.2.10 IBP Setup 27 3.3 Printer 28 Chapter 4 Operation 29 4.1 ECG 29 4.2 SPO2 31 4.3 NIBP 33
4.4 RESP(without in standard version, according to customs order) 35
4.5 TEMP 36
Chapter 5 Maintenance and Troubleshooting 37
5.1 Maintenance 37
5.2 Troubleshooting 38
5.3 Warranty and Repair 38
5.4 Storage and Transportation 40
5.5 Package and Accessories 40
CHAPTER 1 Introduction
1.1 Profile
This manual explains how to set up and use the patient monitor. Important safety information relating to general use of the patient monitor is introduced. Other important safety information is located throughout the text where appropriate. Before using the patient monitor, the user must carefully read this manual so that the user can operate the patient monitor properly and make it reach the specific safety standard and function index.
According to custom’s order we have four types of this product: standard type, standar&CO2, standard &IBP, standard & Inner printer.
1.2 Safety Information
Do not use patient monitor under flammable or anaesthetic condition.
Do not use the patient monitor during Magnetic Resonance Imaging (MRI) scanning. Induced current could potentially cause burns. The patient monitor may affect the MRI image, and the MRI unit may affect the accuracy of patient monitor measurements.
The patient monitor is intended for use only as an adjunct in patient assessment. It must be used in conjunction with clinical signs and symptoms.
WARNINGS
To avoid electrical hazards, never immerse the unit in any fluid or attempt to clean it with liquid cleaning agents. Always disconnect monitor from AC Main Power before performing cleaning of maintenance.
If monitor becomes accidentally wet during use, discontinue operation of the monitor until all affected components have been cleaned and permitted to dry completely. Contact your local INFINIUM representative if additional information is required.
When replace the fuse, please with the new one which the type and the rating current are the same with the used one.
Before use the equipment, inspect whether all the cables are in good condition, the damaged cables and connectors must be replaced. Operator should examine that whether the system is in correct working state and operating condition.
If the equipment has not been used for a long time, please remove the batteries.
Keep the fan running when the equipment works in high temperature for long time, otherwise the high temperature may affect the monitor function or cause the equipment damage.
Make sure Monitor is in horizontal condition and fixed in case of falling down the road. As with all medical equipment, carefully route patient cabling to reduce the possibility of
patient entanglement or strangulation.
If the accuracy of any measurement does not seem reasonable, first check the patient’s vital signs by alternate means and then check the patient monitor for proper functioning. The monitor can monitor only one patient synchronously.
The medical equipment must be manipulated by personnel who have already got relative training of operation.
For safe and accurate operation, use only INFINIUM recommended patient cable, lead wires, cuffs, hose, sensors, tubing, etc. Request for the special children or infant accessories when monitor infant.
Single use devices should never be reused.
The system may not conform to all performance specifications if stored or used outside the environmental specification identified in specification.
When an “X” appears in the Alarm Bell symbol, the audible alarm tone will not sound for any reason.
When connect the monitor to central station, please verify whether the alarm system works properly or not.
All combinations of equipment must be in compliance with IEC Standard 61601-1-1 systems requirements. To avoid potentially hazardous leakage currents, always check the summation of leakage currents when several item of equipment are interconnected.
For proper equipment maintenance, perform the service procedures at the recommended intervals as described in the manual.
If the patient monitor needs to be used continuously long-term, please note to connect the patient monitor with the main power supply by the alarm of battery, otherwise, the patient monitor will automatically shut down, which leads to the break-off of the monitoring.
WLAN device and its built-in RF module may launch interference to other medical equipment. Please comply with the WLAN system install and maintenance manual articles which demonstrate the IMC requirements.
Be sure to use defi-protected electrodes and ECG cable if the monitor is used with defibrillation equipment.
As to the other points for attention, please carefully read the relevant chapter in this instruction.
1.3 Explanation of Symbols
Attention！Refer to the relevant the prompt.
I
Class I EquipmentType CF defibrillator equipment Resistant defibrillator BF type equipment
System menu Trend table
Heart Beat Detected
Description of Abbreviation
ECG ── Electrocardiograph HR ── Heart Rate
Resp ── Respiration
SPO2 ── Arterial oxygen saturation NIBP ── Non-invasive blood pressure IBP ── Invasive blood pressure S ── Systolic pressure D ── Diastolic pressure M ── Mean Arterial pressure TEMP ── Temperature
BPM ── Beat Per Minute Time/Min. PR ── Pulse Rate Time/Min. RR ── Respiration Rate Time/Min.
CHAPTER 2 Overview of the Monitor
2.1 Appearance of Monitor
Screen display
1. Alarm Indicator
If there is physiological alarm, it demonstrates that some parameters measuring scale is beyond alarm limitation, in the meantime, the indicator begin flashing. According to the various alarm level, there are three alarm-level in all for selection:
High level: when alarm occurs, the color of the indicator becomes red and starts flashing once every one second.
Mid level: when alarm occurs, the color of the indicator becomes orange and starts flashing once every one second.
Low level: when alarm occurs, the indicator would be turned on continuously and its color becomes orange all the time.
2. Silence:
Silence setting button, when press it, the alarm of Monitor will be off. 3. Freeze:
5. Print:
Printer button, when Monitor equipped with printer which could be internal thermal array recorder or printer as a peripheral and then press the button, the correspondent data will be printed out.
6. Rotary knob:
User rotate this knob to select and enter desired item, it is similar in function with PC mouse. For more information, please refer to section of Menu operation.
7. Power supply indicator(green light):
Demonstrate power supply status, the power supply is from AC power supply or rechargeable batteries.
8. Indicator of batteries charging state(red light):
The indicator will turn on flashing only when the monitor is powered by the external power and the batteries voltage is low. When the charging end, the red light will light all the time. 9. The yellow button:
Power Supply “on/off” switch. 10. CALL:
Menu refreshing button, when press this button, you could exit current menu and return to the main menu and refresh the screen as well.
Side Panel
1) ECG: ECG lead socket. 2) SPO2 probe port.
3) 4) IBP1, IBP2 socket. (Reserved，supply According to custom’s order)
5) NIBP: Cuff and air tube port
6) 7) T1, T2 Probe port, two ports for selection.
Rear Panel
(1) NET: net access point: connecting with the central monitoring system through the standard RJ-45
(2) (3)USB1,USB2 (reserved) (4)Speaker (reserved ) (5) AUX OUTPUT (reserved)
(6)VGA MONITOR:CRT exteriorly connecting screen and standard VGA. (7)Ground terminal: Ground terminal of equivalent potential.
(8)Power: AC Power supply: 100-230 V(AC), 50/60(Hz)；fuse: 1.6A
2.2 Special Features
Portable, compact, AC power and internal rechargeable battery 8.4 " active matrix TFT display
Can be monitored when the waveform is freeze Friendly interface, easily to operate
72-hour trend data records
Anti-high-frequency electrosurgical equipment More trend graphs
2.3 Specification
Dimension: 258mmX120mmX243mm Weight: 3.5kg with 0.79kg battery
4.5kg with package
Packing list: Monitor. ECG cable, spo2 sensor, NIBP cuff, temp sensor, printer (optional)
1、
、
、ECG
、
7-Lead: I、II、III、aVL、aVR、aVF、V
Display Gain Scales:2.5mm/mV, 5mm/mV,7mm/mV,10mm/mV,15mm/mV,20mm/mV, 25mm/mV
Sweep Speed: 12.5mm/s、25mm/s、50mm/s three classes can be changed Frequency Response: 0.05Hz-100Hz(3dB)
Heart Rate:
Range: 15bpm-300bpm
Accuracy:＜100bpm ±1pm ≥100bpm ±2%
Arrhythmia analysis: Analysis functions of 10 kinds of abnormal ECG waveforms.
32 times ECG data storing function and 4 seconds storing of every time
Accuracy: Error examination rate < 20% Miss examination rate< 20% (Please start analysis function when use the above two functions) ST Segment: Range : ±0.8mV Accuracy:＜ ±0.05mV
2、
、
、SpO
、
2 Range: 0%-99% Accuracy: 70%-80% ±3% 81%-99% ±2%3、
、
、NIBP
、
Technique: Oscillometric method
Cuff Inflation Time: ≤15s measuring time: ≤50s
First Inflation Measurement:
AUTO: 24kPa 180 mmHg）
Manual: 9.3kPa(70 mmHg)、13.3kPa(100 mmHg） 16.0kPa(120 mmHg)、18.6kPa(140 mmHg） 20.0kPa(150 mmHg)、21.3kPa(160 mmHg） 24.0kPa(180 mmHg）
Measurement Interval Time: 1 min -240min
Step: 1 min(1 min -10min)、5min(10 min -30min)、 10min(30 min -90min)、30min(90 min -240min） Measurement Range:
Systolic: 4kPa -34kPa (30mmHg -255mmHg) Diastolic: 2kPa -29.3kPa (15mmHg -220mmHg)
Measurement Accuracy:
Static Pressure: ±3mmHg Pulse Rate: ±2%
4、
、
、Resp:
、
● Trans-thoracic impedance (RA-LL) Range: 2bpm~100bpm
Accuracy: 15bpm~60bpm ≤2bpm 60bpm~100bpm≤5bpm
●CO2 method ( The standard monitor without this method) RR Range : 2bpm~60bpm(including Neonatal） RR Accuracy : ±1bpm
5、
、
、Temp:
、
2 (T1 and T2) channels
Type: Rectal/Skin Range: 0℃～50℃
Accuracy: during the 25℃～45℃, the measuring error≤±0.2℃
6、
、
、Waveform Display:
、
Monitoring waveform
ECG waveform: Scan manner Trend Waveform Full-channel Range:72 hours
7、
、
、Alarm Range:
、
Parameter HR (bpm) Systolic (kPa) (mmHg) Diastolic (kPa) (mmHg) Mean Arterial (kPa) (mmHg) SpO2 (%) RR （bpm） TEMP （℃） （Fº） Difference in temperature （℃） （Fº） PR (bpm) Upper Range 30-300 12-34 90-255 8-29.3 60-220 4.6-29.3 35-220 80-100 10-120 25.5-45 77.9-113 40-254 Lower Range 15-160 8-29.3 60-220 4-24 30-180 4-26.6 30-200 70-99 5-80 25-44.5 77-112.1 0.1-20 0.1-36 20-1608、
、
、Default Alarm Setup:
、
Parameter HR (bpm) Systolic (kPa) (mmHg) Diastolic (kPa) (mmHg) Mean Arterial (kPa) (mmHg) SpO2 (%) RR （bpm） TEMP （℃） （Fº） PR (bpm) Upper Range 120 21.3 160 12.6 95 14.6 110 100 20 39.5 103.1 120 Lower Range 50 12.0 90 8.0 60 8.0 70 80 5 36 96.8 509、
、
、Power Requirement:
、
AC 100V-230V±10%、50Hz/60HzInternal Battery，can work1~2 hours continuously
Caution: Must remove the batteries from this unit when you not going to use it for a long period of time (about one week).
10、
、
、
、Working Temperature:
Temperature: 5℃-40℃ Humidity: ≤80%（No Condensation）
Chapter 3 Menu Instruction
3.1 Display Screen
DEMO State
Fig.1
The first and second channels are the ECG waveform, the third channels is SpO2 waveforms,
the forth channel is RR waveform Measuring State
Note: The measuring state picture is shown as Fig.2. The difference between DEMO state and the Measuring state is that there are apparatus temperature displaying and remaining electric quantity displaying (see Fig.2).
When the remaining electric quantity becomes shortage or the temperature no less than 50
℃,the sound alarm will alarm, and the relevant displaying will turn red simultaneously(see Fig.3).
When the remaining electric quantity becomes shortage, please connect the external power. Otherwise the unit will power off in five minutes. When the apparatus temperature no less than 50℃, please turn on the fan. If the fan has already been turned on, please power off the apparatus, otherwise the apparatus may be damaged.
ECG waveform ECG waveform SPO2 waveform RESP waveform Data Table HR,Lead, ECG analysis of ST segment Blood pressure value Hand/auto operating switch Measuring unit Measuring count down Difference of T1&T2 channels T1 channel temperature T2 channel temperature SPO2 PR Breath Rate
Fig.2
Fig.3
3.2 Menu Operation
In monitoring status, rotate the knob to highlight the MENU icon, and then press the knob, the menu bar of “system setup” appears on the bottom of screen.
The “system setup” menu includes 6 items. Rotating and pressing the knob to select the menu to be set. Having finished the setup, just press “RETURN”, the system will return to the previous menu. All the settings will be stored automatically when powering off the monitor.
A． Time Setup
Select “TIME SETUP” item in “SYSTEM SETUP” menu to access the sub-menu of “TIME” B. Volume Setup
Adjust the volume of Heart beep sound and Alarm sound, Total 8 levels. C. Printer Setup
This mode not support （supply according to custom’s order） D. Color Setup
The item is used to define the color of the waveform and parameters displayed on the screen.
E. Displaying Mode ( The following pictures are all in the DEMO state ) Mode 1: Standard Mode
Fig.5
Mode 3: IBP Extend: (Only the IBP type unit has this picture, supplying according to custom’s order)
Fig.6 Mode 4: ECG Extent:
Fig.7 Mode 5: Graph Ext
Fig.8
internal temperature of the monitor is over 50℃, the fan will start working automatically, and it will be off automatically when the temperature is below 45℃ .
Bed Setup: Indicates the only bed number of the patient being monitored when the patient monitor is connected with the workstation, it always shows on the top left corner in the monitor status frame.
Setup: By this item you can realize communication with the 808 module.
A.SEND: Select the “send” item and confirm, you will see the following menu.
CHANNEL: The channel form which the heart rate is computed.
LEAD SLE: The type of lead. (When the type is “LEAD Ⅲ” ,the heart rate is only can be computed from the ChannelⅠ.)
ECG FORM: The screen only can display one channel’s waveform. You can set which channel’s waveform is displayed.
AGE MODE: You can set the age mode through this menu.
PACE SLE: You can set the information that If the patient using the pace maker. 808 ID: Read the ID number form the 808 module.
B. RECEIVE: By this menu you can see the following message.
3.2.2 Trend table:
pop out the menu shown as below:
A. Table display
A.1 Enter menu of trend table:
The latest 72-hour data table can be displayed at every 1 minute. The first column shows the items of the parameters. The first and the second line of the table indicate the date and time of measurement respectively. The left column of the table always shows the latest measurement. Rotate the knob to turn pages. The page number is displayed on the bottom right corner. When “END” appears, it indicates this is the last page of records.
Press “SILENCE” function key to enter the “set page”. Rotate the knob to set the passing pages at each switch. Press “SILENCE” again to exit the page set，and then rotate the knob to turn the pages you want.
Fig.9 A2 BP Trend Table
Fig.10
A3 IBP Trend Table( Only your unit install the IBP module, you can see this table.)
Fig.11 A4 Alarm Record:
Fig.12 Standard type
Fig.14 Standard & IBP B. GRAPH
Take the HR graph for example:
Trend time: Time span of every page, there eight hours, 24hours and 72 hours for selection. When select “ERASE?” you can delete the former trend records (it needs restarting).
C. OxyCRG
OxyCRG display the HR, SPO2 and the RESP rate at the same time.
Fig.16 D. Trend time
8 hour, 24 hour and 72 hour are available. The y-axis indicates time, select item ERASE to delete the history data record.
3.2.3 Alarm Setup
:In monitoring status, rotate the knob to highlight and then press the knob, the menu bar of “Trend setup” appears on the bottom of screen.
In “Alarm Setup” Menu, you can set the alarm information of following parameters: HR, BP, SoP2, RESP, TEMP and setup the upper and lower alarm limit.
Choose “Low” “Mid” “High” to setup the alarm. The sound is different in each alarm levels: High Alarm: Sound mode is DO－ DO－ DO－ DO DO, the alarm light is red.
Silence OFF
Silence ON
3.2.5 ECG Setup:
In monitoring status, rotate the knob to highlight the “ECG”, and then press the knob, the menu of “ECG setup” appears on the bottom of screen as shown below.
A. Amplitude
Pick this item to access the amplitudes setup of ECG waveform. There seven selections are available: 2.5mm/mV,5mm/mV, 7mm/mV, 10mm/mV, 15mm/mV ,20mm/mV, 25mm/mV, B. Alarm
B.1 Alarm setup: set up high and low limit of HR alarm. The monitor will alarm with light and sound if the patient‘s HR is higher 120 times/min or lower 50 times/min based on above picture.
B.2 state of alarm setup: set ON/OFF with HR parameters alarm individually B.3 lead alarm setup: set ON/OFF with Leadoff alarm individually
C. ANALYSE
Select “ANALYSE” item in ECG setup menu to obtain the ECG analysis function. D. CASCADE
When choose ON, System display same lead in Channel 1 and Channel 2 When choose OFF, System display different leads in Channel 1 and Channel 2 E. SPEED
The menu defines the sweep speed of ECG waveform, the available options are 12.5mm/s, 25mm/s, 50mm/s, select the proper sweep speed according the clinical requirement. F. OTHER
Filter mode: In this menu you can select “Filter close”,”
There are three filter modes for selection. DIA-MODE, MON-MODE, OPR-MODE, FILTER may reduce interference from other electro surgery equipment.
The difference mode is the corresponding bandwidth.
OP MODE :Operation mode, bandwidth: 1 - 25 Hz MO MODE :Monitor mode, bandwidth: 0.5 - 75 Hz DG MODE :Diagnosis mode, bandwidth: 0.05 - 100 Hz
FILTER ON :bandwidth: 1- 50 Hz ，display the ECG waveform in LEAD OFF condition.
3.2.6 NIBP setup
Under the monitoring state, rotate the switch until the cursor focus on the position of NIBP. Press the rotary switch，
Pop up the menu from the bottom of the screen。
A、 Alarm setting up
SYS 、MEAN、DIAS : The alarm setting of systolic, mean and diastolic can be set individually. ALARM: The alarm for HR parameter can be set solely.
CALIBERAT: The repairman from manufacture can be set this item exclusively.
B、 Unit Conversion
Under the menu of NIBP setting up to select item of Unit Conversion, then mmg and KPa will be available. You can notice the measuring result will be displayed with selected unit.
C、 CYCLE
Under the menu of NIBP setting up to select Measuring interval, then different measuring interval are available including the measuring mode and measuring period. In addition, you can set measuring mode to Manual or Cycle, Note: the automatic measuring period can be set from 1 min to 240mins.
D、 Measuring mode
Access NIBP SETUP menu and pick the MODE item to set the type of monitoring patient. There are two monitoring modes: ADULT and INFANT. The AUTO mode is adult.
When measuring the child, please ensure to select the lower inflated pressure. Setting10 kPa (70mmHg) and 13.3kPa (100mmHg) is the neonate mode.
When setting the auto adult mode, inflated pressure is 22 kPa (165 mmHg). Normally, due to the oscillometric technic, the setup of inflated pressure greatly affects the result of the monitored NIBP value. The highest inflated pressure is 4 kPa (30 mmHg) more than the Systolic pressure.
E、 Non-stop (STAT)
In the STAT mode, the monitor measures the blood pressure as many times as possible in five minutes. Pick NIBP SETUP menu and select the STAT item to
A. AMPLITUD
Under the menu of SPO2 setting up select AMPLITUD, then rotate the switch to choose suitable the SpO2 wave amplitude.5 items in all for selecting.
B. AVERAGE
Under the menu of SPO2 you can notice the item of Average, which means the average pulse rate according to calculation of SPO2 measurement for each time.
C. PR SOUND
It is for setting sound on/off of pulse beep. D. .ALARM
b
Six items are available for the user to set up, which are PRALARM (Alarm setup of PR), LEVEL, PROBEOFF, HIGH (high limit of SpO2%), LOW (low limit of SpO2%) and ON/OFF (alarm on or off). When use the knob to select each item and press the knob, a pull-down list appears for the user to choose his desired selection.
E. WAVEFORM
It is for setting the mode of displaying SpO2 waveform. Pick the “FILL” item in “WAVEFS” menu to change the waveform type, you change it into the type of “line” by similar operation. F. RETURN
Press return to return the main menu.
3.2.8 RESP Setup:
In monitoring status, rotate the knob to highlight the RESP icon in
the RESP displaying area, and then press the knob, the menu of “RESP setup” appears on the bottom of screen
A. AMPLITUD
Pick this item to access the amplitudes setup of RESP waveform.12 selections are available。
B、 TYPE
It is for setting the type of RESP measurement. Two methods are available: IMDPRESP trans-thoracic impedance; CO2 (end tidal CO2, the standard unit doesn’t have this selection,
supplying according to custom’s order).
NOTE: When you select RESP measurement, the waveform type is line; and when you select the CO2 measurement the waveform type is full filled.
Select “ALARM” in RESP menu to call up the sub-menu and ready to adjust alarm level and related parameters.
APNEA: You can set the APNEA on or off by this item. You can set the examination time during 5-90 seconds, and the interval time is five seconds.
See “3.2.3 for alarm setting up.
D、 CO2SETUP (The basis version monitor doesn’t have this selection, only the CO2 type unit has )
E、 RES FORM : You can set the lead form which the respiration form from.
F、 RES MUL: You can set the gain of respiration by this menu.
G、 Press button Return to return main menu.
3.2.9 TEMP Setup:
In monitoring status, rotate the knob to highlight the TEMP icon in the TEMP displaying area, and then press the knob,
the menu of “TEMP setup” appears on the bottom of screen as shown below:
A． UNIT
Pick this item to set measurement unit: Centigrade (℃) or Fahrenheit (℉). B． ALARM
Select “ALARM” in TEMP menu to call up the sub-menu shown as below:
Temperature up-and-down limitation can be set. Select the LEVEL you can set the alarm on/off Difference of two types of temperatures can be set. Press button Return to return to main menu.
3.2.10 IBP Setup (Only the IBP type unit has this function item.)
Note: Only when the unit install the IBP module, and set the display mode as “IBP extend”, this setting becomes effective. The displaying mode setting see chapter 2.1.
In monitoring status, rotate the knob to highlight the NIBP icon in the NIBP displaying area, and then press the knob, the menu of “NIBP setup” appears on the bottom of screen
UNIT
ALARM
RETURN
B. ALARM
Set the BP up and down alarm of IBP1 and the alarm state. C. CALIBERAT
Pressure calibration. By tow points setting to amend the IBP coefficient.
D. PRESSURE UNIT
You can select mmHg or KPa as the displaying unit. E. Fiducial value
For value setting of IBP waveform DC fiducial, when the proportion is relevant high, you can set the fiducial value to stand out the AC waveform.
F. Waveform proportion
You can set the waveform amplitude as 2.67kPa(20mmHg/cm),5.34kPa(40mmHg/cm),8.00kPa (60mmHg)/cm,10.67kPa(80mmHg/cm),13.33kPa (100 mmHg)/cm or 26.67kPa (200
mmHg)/cm。
G. Pressure indicate
You can setting by the position of the pressure tube, the relevant sign will be displayed in the IBP data table.
ABP：Directness artery pressure PAP：Pulmonary artery pressure CVP：Center vein pressure
3.3 Printer
Connection for printer
Outer printer: connect the printer to the PRINT port.
Inner printer: We have inner printer type 6000DP M3, supplying according to the customs order.
Chapter 4 Operation for the Equipment
4.1 ECG
4.1.1 How to put the electrode in place.
12 pieces of ECG leads are available. To activate one lead which directly link to patient’s correspondent body feature, then the associated waveform will be shown on the screen. You must be cautious when install the electrode.
1、 Electrode selection and application
（1） Generally speaking, monitoring electrode use the Ag-AgCl, the disposable electrode. Make sure the electrode within warranty before application. （2） For one patient, the same brand electrode is recommended; the purpose
is to avoid different input impedance. 2、 Precondition
For patient’s skin is not in a good condition, which need to be preconditioned before placing electrode in order to make the leads connect to skin tightly.
（1） Washing skin completely using soap and water. Ether and pure alcohol is prohibited because they can increase skin’s impedance.
（2） Shave body hair on where electrodes are placed, if necessary
（3） Rub skin briskly to increase capillary flood flow in the tissues and remove skin scurf and grease.
（4） If electrodes without conducting cream are used, conducting cream should be smeared on skin before placement.
3、 Placing the electrodes for ECG monitoring
Black (N) electrode: be placed on the right hypogastrium. Green (F) electrode: be placed on the left hypogastrium. White(C) electrode: be placed on the chest as illustrated. Recommended ECG lead connection.
WARNING
When using electrosurgery equipment, leads should be placed in a position in equal distance from electrosurgery electrotome and the grounding plate to avoid cautery. Electrosurgery equipment wire and ECG cable must not be tangled up.
The placement of ECG electrodes is depended on the type of operation. For example, electrode can be placed in back or flank of chest for operation of opening chest. Sometime ECG wave can be influenced with artificial because of using ES in operation room. In this case, place electrodes at left and right shoulder close with left and right side of abdomen and chest lead at left side of internal in chest to avoid placing in upper arm, which will lead ECG wave smaller.
WARNING
When using electrosurgery equipment, never place an electrode near the grounding plate of the electrosurgery device, otherwise there will be a great deal of interference with the ECG signal.
4.1.2 Freeze
Under the state of ECG monitoring, in order to further observe the patients’ ECG waveform, you can adopt the function of freeze. Press button Freeze, the scanning waveform just having read will be frozen. Then the doctor can analyze the patient’s condition more precisely. The standard signal for this is 1mV, compared with ECG waveform, the results will be available immediately.
4.1.3Caution
For the movement of the lead cable will result in the inaccurate HR value, try to avoid the interference.
Do not touch the patient, table and equipment during anti-vibration.
Lead-off The specific lead will be displayed when the lead is off from the patient’s body. All Lead off will be displayed when over two leads are off from patient’s body.
“ECG ERROR” indicates ECG board with trouble. Please stop ECG monitoring at once and
contact with the distributor or Customer Service Dept. of Manufacture.
4.1.4 Maintenance and Cleaning
WARNINGS: Power must be shut off and main supply plug must be pull out before cleaning monitor or sensor.
If the ECG cable has been damaged or eroded, please change the cable. Strongly suggest that you do not use the defective cable to monitor the patient.
Cleaning:
Use the warm water or 70% alcohol solution to submerge an velvet cloth to start cleaning operation.
Sterilization
It is suggested sterilization on instrument is going only when it is required by hospital regulation in order to avoid long-term damage on instrument. We also suggest that the product used to sterilize our instrument is cleaned first.
Recommended sterilizing solution:
Ethanol: 70% alcohol，70% isopropyl alcohol； acetaldehyde；
Disinfection: It is suggested disinfection on instrument is going only when it is required by hospital regulation in order to avoid long-term damage on instrument. We also suggest that the product used to disinfect our instrument is cleaned first.
4.2 SPO2
4.2.1Measurement
Plug the SPO2 probe into the related socket on front panel and put finger in the finger grove as well. When begin to measure SPO2 value, the SPO2 saturation waveform, SPO2 value and pulse rate are available. SPO2 displayed on the area of “— —”, when occurs bad connection of probe, the icon of “PROBE OFF” will show on the screen. When there is something wrong with the data communication, the icon of “PLETH ERROR” shown on the screen and alarm at the same time.
4.2.2 Pulse rate sound and over-limitation alarm
Under the normal status, you could hear the sound of mocking pulse rate during measuring SPO2, meanwhile, the sound will increase or decrease along with the indicate value of SPO2. You can notice when the SPO2 is less than 80, you can not hear any difference about the sound. If you want to eliminate the sound, press the button Silence and a crossing bar will through the item of speaker on the screen as well.
When the measuring value over the up limitation, there will have sound and light alarm appeared. Meanwhile you can notice the flashing readings on the screen. The specific alarm setting up please refer to related section of this instruction.
4.2.3 SPO2 waveform and average rhythm
The waveform located on the third area indicates SPO2 waveform, its amplitude demonstrate how much the patients’ pulse rate. By and large, the amplitude can be adjusted by the monitor automatically. Apart from this method, user can also adjust the function in the associated menu.
4.2.4 Precaution for SPO2 measuring
Please apply the same brand SPO2 probe produced by designated manufacture, other unauthorized probe may not be compatible with the SPO2 module.
Please do not use defective SPO2 probe, otherwise may cause damage to the SPO2 module.
Please do not expose the photo component inside the SPO2 probe, once the problem occurred, suggest you do not adopt this probe for ever.
The SPO2 is not waterproof, so please do not submerge it under the water or other solutions.
Excessive patient movement may affect the measuring precise.
Prolonged and continuous monitoring may increase jeopardy of unexpected change of dermal condition such as abnormal sensitivity, rubescence, vesicle, repressive putrescence, and so on. It is especially important to check the sensor placement of neonate and patient of poor perfusion or immature dermogram by light collimation and proper attaching strictly according to changes of the skin. Check per 4 hours the sensor placement and move it when the skin deteriorates. More frequent examinations may be required for different patient.
If set the SPO2 up-limitation to 100%. It means no up-limitation. But high SPO2 value for new born baby have bad effect on them, you should set the SPO2 up-limitation cautiously according to the clinic trial.
In addition, the light-absorption status must be concerned. Other spectra may have side effect on the measuring result, For example:
a． methemoglobin b． methylene
The following conditions may fail to get the real result. a. Improper sensor application
b. External illumination more than 5,000 lumens/square meter (typical office lighting) c. Do not perform SpO2 measuring and NIBP measuring in same limb, because
obstruction of blood flow during NIBP measuring may adversely affect the reading of SpO2 value.
4.2.5 Maintenance and Cleaning
WARNING:
Cut off and disconnect the AC power before cleaning the monitor or sensor.
Do not immerse sensor completely in water, solvents, or cleaning solutions because the sensor and connector are not waterproof.
cable is detected, stop using it immediately. Cleaning:
Moisten the soft cloth or gauze with alcohol and use it to wipe the surface of sensor, and then use the clean cloth to dry it. The same method can be used to clean the light source and photo detector.
Cables can be disinfected by 3% of hydrogen-peroxide or 7% of isopropyl alcohol .Do not immerse the connector into the liquid.
4.3. NIBP
4.3.1Connection
Firstly, make sue no air in the cuff and connect it to the cuff socket located at the rear panel. Secondly plug the cuff hose to machine tightly. (if execute the contrary operation, press the inflating tap and pluck out the air hose)
Referring to ensuing procedure , make sure the cuff is completely deflated.
Apply the appropriate size cuff to the patient, and make sure that the symbol “Ф” is over the appropriate artery. Ensure that the cuff is not wrapped too tightly around the limb. Excessive tightness may cause discoloration and eventual ischemia of the extremities.
The width of the cuff should be either 40% of the limb circumference(50% for neonates) or 2/3 of the upper arm length. The inflatable part of the cuff should be long enough to encircle 50~80% of the limb. The wrong size of cuff can cause erroneous readings. If the cuff size is in question, then use a larger cuff.
4.3.2Measuring mode
There are there types of mode for selection: Manual
In which one measurement of each of the three blood pressures (Systolic/Mean Arterial Pressure/Diastolic) is made and displayed in the numeric frame.
Press START/CANCEL button on the front-panel. A single blood pressure measurement will be made. Press START/CANCEL button again to cancel this measurement.
The measurements remain in the numeric frame as long as what you set up.
As soon as an NIBP measurement begins, any existing NIBP values in the numeric frame are removed, and the current, variable value of the cuff pressure is shown. Systolic, diastolic and MAP values are presented when the measurement is completed. If fail to measure, the numeric frame displays “_ _”
successively measure patient’s BP after taking break for the time you set in “CYCLE” item If you press “START” menu during AUTO mode, the measurement in progress will stop to another manual measurement. After this manual measurement, the device will enter AUTO monitoring mode again. You want to get the patient’s NIBP value by manual operation, just pick “MANUAL” in “CYCLE” item.
STAT(not-stop)
In the STAT mode, the monitor measures the blood pressure as many times as possible in five minutes. Pick NIBP SETUP menu and select the STAT item to set the monitoring mode.
BP measuring failure
When no BP measuring value, system will measure blood pressure automatically, if there are no value for three times, then the system will refuse to measure again. How to stop the BP Measurements
If a measurement is in process, press the START/CANCEL switch whenever that you wish to cancel the current measurement. If an automatic measurement is underway, the interval time will be reset.
The measurement values will be displayed after normally measurement. Alarm will be activated if those values out of limit. Only visible alarm can be seen when the audible alarm be disabled. Refer to the ALARM chapter for information.
WARNINGS
On the whole, when the measuring value is within the setting range, then you can read the normal measuring results. If the measuring results over the up-limitation, the alarm will be activated. When turn off the sound, only the visible alarm is available.
If last the BP value also displayed on the screen before refreshing. If there has huge difference for BP when tested twice by the same person, therefore, the machine can not identify such variation and no alarm activate as well.
Sometimes, to measure the NIBP for a long time, you can feel uncomfortable meanwhile along with the symptom of inadequate blood supply.
Do not measure the blood pressure and SPO2 at the same arm, maybe the blood pressure operation could affect the SPO2 results.
Do not apply the cuff bag in the arm which is carrying out transfusion.
When the measurement be performed on the infant and neonate. Make sure that correct mode setting has been selected (refer to NIBP menu setting section). For higher adult NIBP doesn’t fit for infant and neonate, wrong selection of patient mode may be dangerous to them.
Avoid squeezing and bonding cuff bag to have bad effect on BP measuring.
Inaccurate measurements may result from such causes:
a. Limb’s twitch and tremble will cause inaccuracy or prolonged the cycling of measurement, serious tremble will lead to the failure of measure.
b. Placing the cuff too loosely or tightly on the patient. c. Leaky cuff or hose
d. Insure the NIBP and pulse rate within the range of this monitor.
e. Excessive patient motion will cause the inaccuracy, patient should be relax and avoid movement.
f. patient with hemiplegy.
4.3.4 BP safety protection
Automatic deflation will be activated when the cuff pressure exceed 280 mmHg under the adult mode and exceed 150 mmHg under the infant mode.
Automatic deflation will be activated when the continuous inflation last more than 30 seconds. If there is no value when measurement time exceeds 120 seconds under the adult mode and 90 seconds under the infant mode, the measurement will be canceled.
Patient can press the START/CANCEL button whenever it is necessary.
4.3.5 Maintenance and Cleaning
WARNING:
Do not squeeze the hose of cuff.
Do not allow liquid to enter the connector socket when cleaning the monitor. Or perhaps damage the machine.
Take out rubber tube before cleaning, the cuff wrap can be disinfected by high pressure in heating air box. Or submerge it to the cleaning solution which should first take out the plastic bag. You should not wash the cuff by drying cleaning method, you can wash it in the washing machine or with manual which could prolong the life of the cuff wrap. Put the plastic bag in after cleaning. Make sure the cuff wrap is dry.
Warning
The monitor just can measurement HR times can not be sued to measurement asphyxia and monitor neonate.
The monitor measures respiration from the amount of thoracic impedance between ECG electrodes, the placing of electrodes is important( detailed information please refers to ECG chapter).
4.5 TEMP
Measurement
(1)Plug a reusable TEMP probe into monitor directly. (2)Apply the TEMP probe securely to the patient. (3)Switch on the system.
WARNING
Connect probe to skin directly
Reed data after temperature stable.
Chapter 5 Maintenance and Troubleshooting
5.1 Maintenance
Customers should responsible for periodic maintaining of the product and its accessories. It is very important for our company to warranty the service and repairs. We reserve the rights to change the time limit of warranty and replacement if the following steps are non-implemented:
⑴An effective maintenance plan should be designed for the product and its reusable accessories. It includes periodic inspections and cleaning. It should be accord with the policy of local infection control department or health institution.
Be sure to disc
⑵ onnect power line to the product before cleaning and inspecting.
Periodic cleaning (accordance with the policy of local infection control department or health ⑶
institution). Dampen a cloth with a commercial, nonabrasive cleaner and wipe the tip, bottom, and front surfaces lightly. The following admissive liquor can be used:
● Ammonia (diluted), ● Glutaraldehydea,
● Sodium hypochlorite bleacher (diluted) ● Mildness suds (diluted).
Please obey the following rules to prevent from damaging the product: ● Always using diluted liquor recommend by the manufacture.
● Always wipe up cleaning liquor after cleaning. ● Always not use cleaning matter containing wax.
● Always not spray water or cleaning liquor over the product, neither allows any liquid to flow into power switcher, connector, or other intake.
● Always not use the following cleanser:
○ any kinds of abrasive cleaner and menstruum ○ acetone
○ ketone
○ spirituous cleanser ○ lycine.
● In order to clean display, please use clean flexible cloth and make it wet with cleanser in the glass. Always not spray cleanser in the glass on the screen, neither use alcohol or medical disinfector, such as glutaraldehyde or lycine.
● Do not power on/off frequently.
● Take down and safekeeping probes, lead wires, gluey tube after using product. ● Please hold the product in packaging if the product would not work for a long time. ● Do not make the product contact with chemical medicine and reagent.
● Battery Maintenance
If the PATIENT MONITOR has not been used for a long period of time, please fetch out the batteries.
If there is any abnormity, stop working. It can be reused after inspecting and repairing by technician.
5.2 Troubleshooting
1．．．．NO display after power on, power indication off. Check the power connections, the power adapter.
2．．．． ECG wave wrong display under patient monitor mode. Check the LEAD wire and the electrodes position.
3．．．．No SpO2 wave and pulse rate display when monitoring Check the probe connection and the finger temperature 4．．．．Cuff inflation lacked when measuring blood pressure.
Cuff too loose or leak, Check the connections of tube. 5．．．．No ECG analysis function
Check this function open or not in ECG menu 6．．．．Can not printing
Check the print cable, print power, printer setup and the printer type.
5.3 Warranty and Repair
1、Warranty and repair content
(a) Repair response time: AM9:00 to PM17: 30 on Monday to Friday except legal holiday. Repair time: AM9:00 to PM17: 30 on Monday to Friday except legal holiday.
Repair service: Including telephone support, field inspecting, fittings replacement.
(b)Telephone support: we can give guidance to customer’s engineer to inspecting the instrument when you dial our service line, the professional repair engineer online provides technical support.
Field inspecting: we will send engineers to repair the instrument if necessary. Certified engineers of our company or local repair team trained by our company provide this service.
Fittings replacement: if necessary, we will replace the damaged fittings according to contract. The damaged fittings should be returned to us expect for special reason. (c) Repair for sponsoring and contributing machine: customer should send the machine to us to
repair.
2、Exemption and restriction:
a） Warranty does not apply to the damage or loss sustained due to well-known act of god, such as fire, earthquake, flood, thunder, cyclone, hail, electrical storm, blast, building collapse, commotion, etc.
b) Non-service items:
·The cost and insurance of dismantling and testing, overhauling, reinstall, transfer, moving the instrument or parts.
·Damage or loss sustained due to inspected or repaired by other institute that is not certified
·Damage or alteration by anyone other than our company authorized service personnel. c) The damage or lose sustained due to connection to peripheral equipment (such as printer, computer etc.), that are not provided by our company are not covered by the warranty.
d) Obligation restriction: In the duration of warranty, if the operators use other fittings that are not provided by us, we reserve the right to cancel warranty
3. Customer guarantees:
a） Read the user manual in details before operation.
b） Operation and maintenance according to the user manual, and guarantee the requests of power and environment
4 .Non-warranty and Non-replacement Policy
● The work environment is not eligible. For example, if the relative humidity exceeds 70%, circuit boards of the instrument may be damaged due to condensate.
● If voltage of power supply is fluctuant and exceeds 240VAC, the power adapter may be damaged.
● There is smear or marks that are not belong to the instrument and cannot be removed from the outside surface of the instrument.
● The instrument or its fittings are mechanically damaged.
● The circuit is short and damaged due to liquor or other stuff flow in the instrument or its fittings.
● All probe and its accessories are not free replacement.
● Leakage of air cell of blood pressure sleeve due to improper storage or operation is not free replacement.
● Damage resulted from mechanic force is not liability for free replacement.
● Any inaccuracy resulted from the current measuring technique when measuring blood pressure. We assume no warranty.
● Not original package for transportation.
● Any malfunction caused by non professional worker or unauthorized personnel for machine repair.
● Do not read the user instructions carefully。 5、Customer special warranty period
Due to we stipulate the warranty period according to the relevant electronic regulation of country, which we stipulate is on year, accessory is three months. When customer requires to extending the warranty period, you should consider whether it is reasonable. Because electronic product quickly replace, as to the warranty period over three years, purchased accessories may be out of stock. In this case, we will adopt to entirely upgrade or replace the old, you should pay the minimum acceptable cost of renewed device.
6. Repackaging
Remove all the detectors, leads and accessories and put them into the plastic bag. ◆
Try to use the original packaging case and materials. An
◆ y damage due to the improper packaging during the transportation shall be responsible by the user.
If you are still within the period of warranty, please present the warranty card and one copy of ◆
the invoice or receipt. ◆
◆ ◆
◆Please present a written note detailing all the troubles when repairing the instrument.
5.4 Storage and Transportation
Storage: Temperature: -10℃~40℃， Humidity: 90%
Transportation: Via road, rail or aviation after properly insured and packaged.
5.5 Package and accessories
The outside package applies the sturdy cardboard while inside fix the machine with vibration relief plastics. Use the anti-dump plastic bag to wrap the machine and put it at the middle of the bag.
No. Accessories Quantity
1 ECG-cable (standard) 1 piece
2 Electrode 1 pack
3 NIBP cuff and extension tube (for adult) 1 piece 4 SpO2 finger clip probe and extension cable (for adult) 1 piece
5 TEMP probe (Skin or rectal) 1 piece
6 Power cable 1 piece
7 Grounding wire 1 piece
5.6 Appendix: Arrhythmia, HR variation, ST analysis
(VFE1.0.0 no support for this function)
In order to get the better result, the highly efficient ECG waveform is a must. Too much noise and interruption will affect the accuracy. In view of the long time patient monitoring, therefore, the results from the monitor is only for reference at anytime and in any situation. All conditions need to be considered by the users to give a conclusion
Some features to judge the monitor
1.No pulse rate:the R wave interval between current and last tempo is bigger than the setting value.（default value is 4000ms）
2.Ignored pulse rate:the interval between current and last tempo is 1.7 times bigger than average interval and 3.2 times smaller than the average interval.
3。High HR:The interval of R wave within 5 continuous tempos is more than the panel threshold value and less than 430ms.（HR more than 140BPM）
4。Lower HR:The interval of R wave within 5 continuous tempos is less than panel threshold and more than 1500ms.（HR less than 40BPM）
Parameter f of HR variation
For more material about arrhythmia, HR variation, ST segment, please contact our company or our agents.
HR variation
Total tempos N: Average RR: Maximum RR(max); Minimum RR(min) Standard offbeat for RR interval:
Average MSD for minus between adjoining RR interval:
Standard offbeat MSDD for minus between adjoining RR interval:
Variation coefficient for SD=SD/RR; Variation coefficient for MSD=MSD/RR; Variation coefficient for MSDD=MSDD/RR;
