Professional Documents
Culture Documents
Operator’s Manual
© 2010 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. All rights Reserved.
, , , , , BeneView,
WATO, BeneHeart, are the trademarks, registered or otherwise, of Mindray in
China and other countries. All other trademarks that appear in this manual are
used only for informational or editorial purposes. They are the property of their
respective owners.
All information contained in this manual is believed to be correct. Mindray shall not
be liable for errors contained herein or for incidental or consequential damages in
connection with the furnishing, performance, or use of this manual.
Mindray is responsible for the effects on safety, reliability and performance of this
product, only if:
the electrical installation of the relevant room complies with the applicable
national and local requirements; and
1
WARNING:
It is important for the hospital or organization that employs this
equipment to carry out a reasonable service/maintenance plan.
Neglect of this may result in machine breakdown or personal injury.
NOTE:
This equipment must be operated by skilled/trained clinical
professionals.
Warranty
THIS WARRANTY IS EXCLUSIVE AND IS IN LIEU OF ALL OTHER WARRANTIES,
EXPRESSED OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY
OR FITNESS FOR ANY PARTICULAR PURPOSE.
Exemptions
Mindray's obligation or liability under this warranty does not include any
transportation or other charges or liability for direct, indirect or consequential
damages or delay resulting from the improper use or application of the product or the
use of parts or accessories not approved by Mindray or repairs by people other than
Mindray authorized personnel.
Malfunction of the instrument or part whose serial number is not legible enough.
2
Company Contact
3
Preface
Electric shock:
Reminding users of electric shock.
Note: Do not remove the shell. Otherwise, electric shock may be
caused.
Warning:
Reminding users to operate as instructed in this manual.
Otherwise, personal injury may be caused.
Biohazard:
Reminding users to operate as instructed in this manual to
prevent biohazardous risks.
Serial number
Date of manufacture
Manufacturer
Storage temperature
4
Safety Precautions
Observe the following safety precautions when using the product. Ignoring any of
these safety precautions may lead to personal injury or equipment damage.
Warning:
If the product is used in a manner not specified by our company, the
protection provided by the product may be impaired.
Biohazard
Observe the following instructions to protect against biohazardous risks.
Biohazard:
Inappropriately handling samples may lead to biohazardous infection.
Do not touch samples with your bare hands. Wear gloves and lab coat
and, if necessary, goggles.
In case your skin contacts samples and mixtures, follow the standard
laboratory safety procedure and consult a doctor.
Waste Disposal
Observe the following instructions to prevent environmental pollution and personal
injury caused by waste.
Biohazard:
Some substances contained in the whole device and the parts are
subject to regulations of contamination and disposal. Dispose of the
waste in accordance with your local or national rule for biohazard
waste disposal. Wear gloves and lab coat and, if necessary, goggles.
5
Contents
Intellectual Property Statement........................................................................................... 1
Responsibility on the Manufacturer Party........................................................................... 1
Warranty ............................................................................................................................. 2
Preface .............................................................................................................. 4
Safety Symbols and Labels ................................................................................................ 4
Safety Precautions ............................................................................................................. 5
Biohazard............................................................................................................................ 5
Waste Disposal................................................................................................................... 5
Contents............................................................................................................ 6
2 Result Units............................................................................................ 10
3 Installation Procedure........................................................................... 13
3.1 Accessory .............................................................................................................. 13
3.2 Operating Environment.......................................................................................... 13
3.3 Outline and Structure of the Device....................................................................... 15
3.4 Powering On .......................................................................................................... 16
3.5 Installation of Paper Roll........................................................................................ 16
3.6 User Interface ........................................................................................................ 17
3.7 Powering Off .......................................................................................................... 17
4 Settings .................................................................................................. 18
4.1 Strip Model............................................................................................................. 18
4.2 Unit......................................................................................................................... 19
4.3 Critical Value .......................................................................................................... 19
4.4 System Clock......................................................................................................... 20
4.5 Printer .................................................................................................................... 21
4.6 Serial Port .............................................................................................................. 23
4.7 Product Information ............................................................................................... 23
5 Testing.................................................................................................... 24
6
Contents
7 Troubleshooting .................................................................................... 33
8 Maintenance........................................................................................... 35
8.1 Daily Maintenance and Tips................................................................................... 35
8.2 Disassembling and Cleaning Feed Table .............................................................. 36
8.3 Disassembling and Cleaning Waste Strip Box ...................................................... 37
8.4 Disassembling and Cleaning Waste Liquid Table.................................................. 38
8.5 Replacement of Fuse............................................................................................. 38
8.6 Replacement of Clock Battery ............................................................................... 38
8.7 Disinfection ............................................................................................................ 38
9 Serial Communication........................................................................... 40
9.1 Cable Connection .................................................................................................. 40
9.2 Basic Specifications ............................................................................................... 40
9.3 Transmission Content ............................................................................................ 41
7
1 System Description
Language: English
Recording mode: Micro thermal printer, LCD, FalshROM, and external printer
Print: Micro thermal print paper, width of 57mm, roll diameter less than
50mm
External printer
8
System Description
Specification Parameter
Communication RS-232C DB9 female
interface
9600, 19200, 38400, and 57600bps
Start bits: 1, data bits: 8, stop bits: 1, parity: odd
Operating environment: The device should be placed on a stable plane platform, kept from
direct sunshine and strong electromagnetic interference, and
properly grounded.
Safety classification: Electric shock protection I type, overvoltage type class II, pollution
degree 2
Table 1.1
9
2 Result Units
10
Result Units
PH 5 5 5
6 6 6
6.5 6.5 6.5
7 7 7
7.5 7.5 7.5
8 8 8
9 9 9
NIT - Neg.
+ >=0.1mg/dL
11
Result Units
Table 2.1
12
3 Installation Procedure
3.1 Accessory
The device is packed in a carton and should be unpacked carefully. Check the
package and device for obvious damage. If you find anything damaged, contact the
shipping agent or your local distributor.
Item Quantity
Certificate of Conformity 1
Warranty Card 1
Operator’s Manual 1
Power cord 1
Fuse 2
Table 3.1
13
Installation Procedure
Warning:
To ensure personal safety and normal running of the device, ground
properly the protective ground wire of the power socket and do not use
a connector board connected with a 2-core wire.
The device is intended for special use and must not be disassembled
without permission. The power switch, main control board, conversion
board, connection wire, and feeder table insert component can only be
inspected and provided by the manufacturer.
Figure 3.1
14
Installation Procedure
The product mainly consists of the light source, optical receiver, feeder table insert,
computer system, and display monitor.
Display
monitor
Printer
Feed table
Waste
paper
box
Figure 3.2
Dual fuses
Serial Port Printer interface Power switch
Power jack
Figure 3.3
15
Installation Procedure
3.4 Powering On
Connect the power cord to the power outlet and toggle the power switch to the “I”
position. The system software starts running and displays the following Logo.
Figure 3.4
The system starts self-checking all components, and then displays the main screen
as shown below.
Figure 3.5
No matter if the device has been powered on or off, open the printer cover.
2. Pull the paper roll for about 5cm and put it on the roller in the correct direction.
3. Install the roller in the printer and lock the roller into the clamping slot. Do not use
excessive force and set the gear side of the roller on the left.
4. Lead the front edge of the print paper through the opening on the printer cover,
and then restore the printer cover.
Note:
When installing the print paper roll, please note that the outerface of
the paper roll is the thermal face.
16
Installation Procedure
Settings Strip
Unit
Critical Value
System Clock Date
Time
Printer Option
Shade
Diagnosis
9600
19200
Serial Port
38400
57600
Product Info.
Table 3.2
Before powering off the device, check that there are no pending strips on the feeder
table, or if any, press to terminate the test, and then switch off the power when
the strips on the feeder table are cleared.
17
4 Settings
On the main menu as shown in the figure below, select Settings to display the
Settings screen.
Figure 4.1
18
Settings
Figure 4.2
Make sure that the strip model you have selected is consistent with the strips you
are using. Inconsistent strips may lead to incorrect results.
4.2 Unit
Select Unit to display the Settings>Unit screen.
Figure 4.3
Choose desired unit type, and then press to confirm selection or press to
return to the Settings screen as shown in Figure 4.1.
The reference range can be defined according to the standards in the laboratory. If
the user needs no judgment on the result of a test item, set the threshold of the test
item as the maximum grade value. In this way, no result of the test item will be
greater than the threshold and no asterisk “*” will appear on the output reports.
19
Settings
Figure 4.4
All test items and reference values of the current strip are displayed on the screen.
Select the desired test item, press to increase or press to decrease. Press
to save the changes and return to the Settings screen, or press to return to
the Settings screen without saving the changes.
On a displayed or printed report, if the test result exceeds the critical value, an
asterisk “*” will appear to remind the operator.
Figure 4.5
Click the date to pop up the following window. Input the date in the format of
yy-mm-dd, and then press .
20
Settings
Figure 4.6
Click the time to pop up the following window. Input the time in the format of
hh-mm-ss, and then press .
Figure 4.7
Select to return to the Settings screen.
The system date and time have been calibrated before the device leaves the factory.
When the device is installed, the user should check the date and time against the
local date and time, and if necessary, change them accordingly. The system date
and time have certain accumulated error and should be calibrated once every two
months.
The test reports are managed based on the sample ID, date and running time. Enter
the date and time correctly to avoid disorder of test report management.
4.5 Printer
The Settings>Printer menu is used to change the printer settings, which include
Printer, Shade, and Diagnosis.
Note: The device, if equipped with a serial port, can be connected with an
external printer to print reports. Since printers are available in many brands and
models, it is impossible that all printers can support the device and meet the
requirements of print format. If the external printer cannot work normally, contact the
manufacturer or the local distributor. The external printer and the internal printer
output data synchronously and cannot be set up separately on the screen.
21
Settings
Figure 4.8
Option is used to enable or disable synchronous printing of test reports during
testing, which is applicable to both the internal thermal printer and the external stylus
printer.
Figure 4.9
Select the desired option and press to save the selection and return to the
Settings>Printer screen.
Shade is used to set the color scale of the characters on the printed reports.
Figure 4.10
The shade is divided into 21 scales. The black and white bar indicates the color
scale. The longer the black bar, the higher the color scale is. Press to increase
the scale or press to decrease the scale, and then press to save the
adjustment and return to the Settings>Printer screen.
While the printed characters are clear and proper, use a color scale as low as
possible in order to increase the print speed and extend the shelf life of the printer.
As the season changes, adjust the color scale accordingly. Decrease 1 to 2 scales in
warm seasons and increase 1 to 2 scales in cold seasons.
Press Diagnosis on the Settings>Printer screen to print a test page through the
internal thermal printer, and then check if the character shade and the printer are
working properly.
22
Settings
Figure 4.11
This screen is used to set the serial port and baud rate for communication between
the device and the computer. The baud rate is available in four options: 9600, 19200,
38400, and 57600. Select the desired option and press to save the selection
and return to the Settings screen.
Figure 4.12
The screen displays the model, serial number, software version, and release date of
the device.
23
5 Testing
The device adopts the continuous testing mode and can test up to 600 samples
every hour.
Test results are managed based on sample ID, which ranges from 001 to 1000. The
sample ID is numbered separately everyday and each sample ID corresponds to one
test result. If a sample is tested for two times, the late result will cover the early one.
Sample ID is generated automatically by the device. When powered on every day,
the device automatically sets the current sample ID as 001. Every time when a
sample is tested, the default sample ID increases by 1. The user is also allowed to
define sample ID.
Figure 5.1
24
Testing
The device searches from the reports on the current day and reminds the operator
of the sample ID when finding the latest report. To change the sample ID, input the
same ID and select ; or directly select . After the sample ID is input, the
testing page is displayed.
Figure 5.2
Above the straight line shows the strip queue, and below the straight line shows from
up to down the strip model, clock, print status, and print paper status. At the
lower-right corner of the screen is the button. Press to terminate a test and
return to the main screen.
Every time when a sample is tested, the result will be used to replace the early one.
Use a hand to place the prepared strip properly on the feed table as shown in Figure
5.3. When a “beep” is heard, it indicates that the analyzer has detected the
placement of a new strip on the feed table and the test will start.
Figure 5.3
25
Testing
Note:
The reagent area of the strip must face up.
Each strip must be placed vertically between the first column of bulge
carriers and the second column of bulge carriers on the feed table.
The far tip (the tip that is not in hand) must exceed the top of the bulge
carriers.
Regular testing procedures: 1) Place the strip on the feed table. 2) When the motion
of placing the strip is detected, the strip is moved into the analyzer (which takes a
few seconds). After seven steps, the strip reaches the testing position. The sensor
reads the strip, gets the test data, and then produces results after analysis.
When the operator is placing the strip, the strip detector detects the motion and
carries the strip into the analyzer. To ensure a certain period of reaction time, it takes
a few seconds before the conveyor belt under the feed table starts to move after a
new strip is detected. This mechanism ensures that the urine is fully reacted on the
strip. Therefore it is normal for the analyzer to stop for a few seconds after a strip is
placed.
After the strip reaches inside the analyzer, there is another confirmation sensor to
confirm there is a new strip in queue. Only after being detected by the confirmation
sensor will the strip be moved to the testing position for testing.
The operator can immediately start the next cycle of strip dipping and drying. After
the previous strip is being transferred to the right and a new strip position is
available on the feed table, the operator can place the next prepared strip, and so
on. Spaces (skips) are allowed between two strips, which will not affect sample
numbering. Samples (strips) are numbered according to the actually detected strips
instead of steps made by the motor.
Note:
Do not place strips on the feed table while the conveyor belt is moving.
Testing reports are displayed on the LCD screen. If the printer settings in section 4.5
Printer are set as “Print”, the test results will be printed out by the embedded thermal
printer and an external stylus printer, as well as by the serial port. The results will be
also saved into the FLASH ROM inside the analyzer. No data will be lost due to
power interruption. The saved testing reports can be recalled any time.
26
Testing
4. Do not pull the feed table or remove the waste box; otherwise the analyzer will
not function correctly.
5. Wash the feed table and empty the waste box everyday.
It is unnecessary to exit the testing window or shut down the analyzer when there is
no sample to test temporarily.
5.4 Troubleshooting
If the feed table is moved or pulled out during testing, the analyzer will display an
error message indicating that the feed table is improperly installed. When the feed
table is moved back to the right position, the conveyor belt steps 13 strip positions to
dump all strips on the feed table into the waste box. Thus the corresponding
samples must be prepared again (soaking, drying, testing…) with new strips.
If the waste box is moved or pulled out during testing, the analyzer will display an
error message indicating that the waste box is improperly installed. If the waste box
table is moved back to the right position in five seconds, the test will resume.
Otherwise after five seconds, the test process will terminate and the conveyor belt
will step 13 strip positions to dump all strips on the feed table into the waste box.
Thus the corresponding samples must be prepared again (soaking, drying, testing…)
with new strips.
When the number of used strips stored in the waste box reaches a certain quantity,
the analyzer displays “Waste Box Full”. At this point, the analyzer can test another
twenty samples. The operator should stop testing as soon as possible and clear the
waste box. Otherwise after another twenty more samples are processed, the testing
will terminate automatically, and the conveyor belt will step 13 strip positions to
dump all strips on the feed table into the waste box. Thus the corresponding
samples must be prepared again (soaking, drying, testing…) with new strips.
27
6 Report Query
dates are listed on the screen in the chronological order. The report dates will be
displayed on more than one page if over 10 dates exist.
The highlighted date is currently selected. To change a report date, click on the date
and then edit it. See the figure below.
Figure 6.1
28
Report Query
Button Operation
View the next page of dates.
Table 6.1
Figure 6.2
Select to delete the reports or select to abort the deletion.
Figure 6.3
29
Report Query
Button Operation
View the first report of the selected date.
Table 6.2
Select a date on the Reports screen and click . A window pops up for inputting
the start sample ID. The default is the first sample ID under the date. Enter the start
sample ID and then press .
Figure 6.4
The following window pops up for inputting the end sample ID. The default is the last
sample ID under the date. Enter the end sample ID and then press .
30
Report Query
Figure 6.5
The reports within the start and end sample IDs on the selected date are printed out
through the internal printer and external stylus printer. To terminate the printing,
select .
Figure 6.6
Select a date on the Reports screen and click . A window pops up for inputting
the start sample ID. The default is the first sample ID under the date. Enter the start
sample ID and then press .
Figure 6.7
The following window pops up for inputting the end sample ID. The default is the last
sample ID under the date. Enter the end sample ID and then press .
31
Report Query
Figure 6.8
The reports within the specified sample ID range are transmitted to the computer. To
terminate the transmission, select .
Figure 6.9
Enter the end sample ID and press START. The test reports within the input start
and end sample IDs on the selected date are transmitted through the serial port.
32
7 Troubleshooting
When some or all functions of the analyzer cannot work normally due to system
failure or misoperation by the operator, an error message will be displayed. The
following table shows all error messages, including error code, error description, and
solutions.
E02 System data error The stored system check and calibration data is lost. The analyzer
cannot work. Please contact retailers for repairing.
E03 Threshold data An error has occurred on System data related to strips. Please
error contact retailers for repairing.
E10 Conveyor belt Conveyor belt origin switch malfunction. Please contact retailers
origin error for repairing.
E11 Conveyor belt Conveyor belt motions malfunction. Please contact retailers for
motion error repairing.
E12 Strip sensor error Strip sensor fails. Please contact retailers for repairing.
E21 Tester Origin Error Tester can’t find its origin. Please contact retailers for repairing.
E21 Tester Origin Tester Movement Error. Please contact retailers for repairing.
Move Error
E22 Abnormal Optical The optical intensity exceeds the valid data range. Please contact
intensity retailers for repairing.
33
Troubleshooting
E30 Printer out of Install new print paper according to 3.5Installation of Paper Roll.
paper
E31 Feed table Check if the feed table is in correct position. Try to install the feed
incorrectly table again following the instructions in 8.2Disassembling and
installed Cleaning Feed Table.
E32 Feed table needs Too much extra sample urine accumulated on the feed table is
to be cleaned detected. Please wash the feed table following the instructions in
8.2Disassembling and Cleaning Feed Table.
E33 Waste box Check if the waste box is in the correct position. Try to install the
incorrectly waste box again.
installed
E34 Waste box full Take off the waste box, dump all used strips, and then reinstall the
waste box.
E42 Strip position error Abnormal position of a strip was detected on the feed table, which
caused the test of that strip to fail. The analyzer will produce an
incorrect report, which takes a report number.
Please continue testing. After all tests are completed, find the
failed report number and redo the rest.
Table 7.1
34
8 Maintenance
2. Often use soft and dry cloth to clean the analyzer. If dirt is found on the surface of
the analyzer, clear it with fresh water. Do not use gasoline, diluted paint, benzene
compounds, alcohol and other organic solvents, which may cause the analyzer to
deform or fade, thus influencing the system performance and appearance.
3. Use clear soft dry cloth or soft paper instead of water to clean the LCD screen.
4. Keep the feed table clean. If urine is accumulated during testing, wipe it with
absorbent paper to avoid influencing the test results due to cross-contamination.
Clean the feed table with fresh water every day.
35
Maintenance
Note:
In view of the properties of strips, do not use it at too high or too low
temperature to ensure accurate results. The ideal operating
temperature is within 10°C ~30°C.
Only use strips that match the urine analyzer. Use the controls
recommended by our company to ensure consistent and accurate
results. Using Bio-Rad Laboratories,Irvine,CA : Urinalysis Control level
1 and level 2.
Disposal of waste strips is subjected to waste disposal regulations.
Please reject waste strips according to the local waste disposal
regulations.
Use fresh sample (collected for 2-3 hours) for testing.
Step 1: Disconnect the power supply and take out the feed table according to Figure
8.1.
Figure 8.1
Step 2: Use a soft cloth to wash the feed table in fresh water and then reinsert it into
the feed table slot. If any resistance is felt, pull out the feed table a little and insert it
again. The feed table must be inserted all the way in.
Figure 8.2
36
Maintenance
Biohazard:
Take necessary protection measures during operation.
Caution:
The feed table is an important part of the device and must be kept
properly. Do not use detergent or hot water to clean the feed table or
bake or heat it. A deformed feed table may directly influence the test
results.
Steps: Shut down the analyzer; pull out the waste strip box; clear all used strips; use
soft cloth or brush to clean the waste box in waster; dry the washed box and insert it
back into the analyzer. When inserting the box, align the track on the box to the
guide in the analyzer and apply force evenly. Push the box carefully until the surface
of the waste box and analyzer cover are level.
Figure 8.3
If urine alkaline remains on the waste strip box, wipe the feed table with cotton
swabs dipped with 0.1N NaOH, and then dry it carefully with absorbent paper.
Biohazard:
Take necessary protection measures during operation.
Caution:
Strips are for single use only and must not be reused. Waste strips
must be processed properly and must not be discarded randomly.
Dispose of waste strips according to the waste disposal regulations of
your laboratory.
37
Maintenance
Steps: Shut down the analyzer, pull out the waste strip box, and reach into the
analyzer to pull out the liquid waste plate. Use water and brush to wash the liquid
waste plate, dry the washed plate and insert it back into the analyzer. After installing
the waste liquid plate, insert the waste strip box back into the analyzer.
Biohazard:
Take necessary protection measures during operation.
Note:
Use the fuse provided with the analyzer or a slow fuse (tube): 5mm
wide, 20mm long, 250V/2A, T2AL250V.
Flip the analyzer to show the bottom side, use a magnetic tip Phillips screwdriver to
remove the seven M3 x10 screws and one M3 x 8 screw. Make sure all of the eight
screws are kept safely. Flip the analyzer right side up, carefully lift the upper cover
up and flip it to the back. A battery holder can be found. Remove the button battery
and install a new battery. The positive terminal of the batter should face the front
side of the analyzer.
Caution:
Waste battery may contaminate the environment and must not be
discarded randomly. Dispose of waste battery according to the waste
disposal regulations of your laboratory.
8.7 Disinfection
1. Prepare the disinfectant in one of the following three ways:
38
Maintenance
0.05% sodium hypochlorite: Add 1ml 5% sodium chlorate (or Clorox Bleach)
to 99ml water to produce 1:100 diluted solution.
2. Pour the disinfectant into a high and thin container for about 4 inches (10cm)
deep.
4. Wait for 10 minutes and then dry the feed table with absorbent paper.
39
9 Serial Communication
Parity: Odd
40
Serial Communication
Parameter Specification
Data length: 8 Bits
Stop digit: 1 Bit
Table 9.1
Data content uses frame as its unit, and one frame data is a report. A frame is
composed of a number of lines, and ends with a line containing ODH and OAH. A
line is composed of fields, which are separated by 09H.
4 Blank line
15 Name of test item 11 Result of test item 11 This line will be blank
in the case of 10 test
items.
Table 9.2
If the test results contain “±” and “µ”, the two symbols will be replaced by “+-” and
“u”.
41
Serial Communication
42
P/N: 046-001848-00 (2.0)