Henry Schein Urispec Plus User manual

User manual

User manual Urispec®Plus
2Manual Urispec®Plus V2.01 HS USA / 04-19
The Urispec®Plus is CLIA waived for Urispec®urinalysis reagent strips.
A certicate of CLIA waiver is required to perform the testing in a waived setting.
If the laboratory does not have a Certicate of Waiver, the Application for Certi-
cation (Form CMS-116), can be obtained at http://www.cms.hhs.goc/clia/. The
form should be mailed to the address of the local State Agency of the State in
which the laboratory resides (http://www.cms.hhs.gov/clia/ssa-map.asp).
Laboratories with a certicate of waiver must follow the manufacturer's instruc-
tions for performing the test. If the laboratory modies the instructions, the test
no longer meets the requirements for waived categorization. A modied test is
considered to be high complexity and subject to all CLIA requirements.
A063439 / xxxx

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1. Quickstart ………………………………………………………………………… 5
2. Introduction and intended use ………………………………………………… 7
2.1. Intended Use and Indications for Use ……………………………………… 7
2.1.1. Measuring Principle ……………………………………………………… 7
2.1.2. Functional Principle Urispec®Plus……………………………………… 7
3. Unpacking and Set Up ………………………………………………………… 11
3.1. List of delivered parts ……………………………………………………… 11
3.2. Description of instrument parts …………………………………………… 12
3.3. Setting up the instrument ………………………………………………… 12
3.4. How to plug the instrument in …………………………………………… 13
3.5. How to load the printer paper …………………………………………… 13
3.6. How to install batteries (optional) ………………………………………… 14
3.6.1. Instrument self test …………………………………………………… 14
3.6.2. Calibration ……………………………………………………………… 14
3.7. Use of the instrument ……………………………………………………… 15
3.7.1. Buttons ………………………………………………………………… 15
3.7.2. Scroll Arrows …………………………………………………………… 15
3.7.3. Round buttons ………………………………………………………… 16
4. User Menu ……………………………………………………………………… 17
4.1. Flow-chart of the Menu Structure ………………………………………… 17
4.2. Description of the Menu Items …………………………………………… 18
5. Analysis of Test Strips ………………………………………………………… 19
5.1. Select strip ………………………………………………………………… 19
5.2. How to perform a measurement ………………………………………… 19
5.3. Display of Results ………………………………………………………… 20
5.4. Measurement Errors ……………………………………………………… 20
5.5. Entering the Patient Identication ………………………………………… 20
5.6. Changing the sequence number ("SN") ………………………………… 22
5.7. Transferring data to a PC ………………………………………………… 22
6. Enter the Main Menu…………………………………………………………… 23
7. Recall results …………………………………………………………………… 24
7.1. How to scroll through memory …………………………………………… 24
7.2. How to nd specic results (ltering) …………………………………… 25
7.2.1. Selecting the Day ……………………………………………………… 25
7.2.2. Selecting Search Criteria……………………………………………… 26
7.2.3. Display suitable matches……………………………………………… 26
7.3. How to delete results from memory ……………………………………… 27
8. Expected waiver performance ……………………………………………… 28
9. Quality control testing ………………………………………………………… 29
9.1. How to run a quality control test ………………………………………… 29
9.2. How to review old QC measurements …………………………………… 30

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10. Equipment Settings ………………………………………………………… 31
10.1. How to modify strip settings……………………………………………… 31
10.1.1. Units …………………………………………………………………… 31
10.1.2. Order of Parameters ………………………………………………… 31
10.2. How to protect settings from unauthorized access …………………… 31
10.3. How to turn the printer on and off ……………………………………… 32
10.4. How to enable and disable acoustic signals …………………………… 32
10.4.1. Acoustic conrmation of user inputs ……………………………… 32
10.4.2. Acoustic warning on positive results ……………………………… 32
10.5. How to deactivate and activate the autostart ………………………… 32
10.6. How to set energy saving options for the battery mode ……………… 32
10.7. How to change the language …………………………………………… 33
10.8. How to set time and date ………………………………………………… 33
10.9. How to activate data transfer …………………………………………… 33
10.10. How to change the text of the printout header ……………………… 34
10.11. How to print settings …………………………………………………… 34
11. Cleaning and Maintenance ………………………………………………… 35
11.1. How to clean the housing ………………………………………………… 35
11.2. How to clean the strip holder …………………………………………… 35
12. Table of Results ……………………………………………………………… 36
13. Service Menu ………………………………………………………………… 37
13.1. How to reset the system (Load Default) ……………………………… 37
13.2. How to update the instrument …………………………………………… 37
14. Interface Description ………………………………………………………… 38
14.1. Serial Interface …………………………………………………………… 38
14.2. USB 1.1-Interface ………………………………………………………… 38
14.3. Transmission Protocol …………………………………………………… 38
14.4. Barcode Scanner, PC-Keyboard………………………………………… 38
14.5. Ethernet-Interface ………………………………………………………… 38
15. Error Messages and Fault Clearance……………………………………… 39
16. Technical Information………………………………………………………… 40
16.1. Technical Data …………………………………………………………… 40
16.2. Security standards………………………………………………………… 40
17. Service ………………………………………………………………………… 41
18. Additional information on security standards…………………………… 42

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1. Quickstart
Unpack the instrument and place it on an even, hard surface. Connect the pow-
er supply and turn the equipment on with the On/Off-switch (Pic. 4-8). After the
self test you will be able to select a strip type. Once you select the strip you want
to use, or after 15 s, the start screen will appear,
0001
1025358
SN:
ID:
(P)
INSERT STRIP!
Urispec 11-Way
Display 1: Start menu
• Dip a test strip (Urispec® urine test strip) into the urine sample for approx. one
second.
• Blot by touching the edge of the strip to a paper towel to remove excess urine.
• Place the strip on the strip holder
• Slide or push the strip to the end of the channel. Do not touch the reagent
pads on the test strip.
The instrument will automatically detect an applied strip. The measurement cy-
cle will be started. A progress bar on the display shows the remaining measure-
ment time.
Note: If "Autostart" is deactivated, the measurement must be started using the
start control panel (see 10.5. How to deactivate and activate the auto-
start, page 32).
NOTE:
The strip will be drawn into the instrument after 30 sec.

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After approximately 60 sec the result will be displayed on the screen and trans-
ferred to the printer and interfaces.
RESULT
Seq.No: 0001
ID: 1234567890
2006.02.17 9:47
*BLD 10 ERY/uL
UBG NORM
BIL NEG
PRO NEG
NIT NEG
KET NEG
*GLU 50 mg/dL
pH 5.0
SG 1.005
LEU NEG
Display 2: Result
By pressing the printer symbol the result can be printed again. Choosing
the return panel will lead back to the start screen.
Another analysis may be started by applying the next test strip.
NOTE:
To start a new measurement it is not necessary to go back to the start screen.
A new strip is detected at any time and the measurement is then started au-
tomatically.

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2. Introduction and intended use
The Urispec® Plus is a reection photometer for the analysis of Urispec®urine
test strips. The measurements are performed under standardized conditions,
measured values may be displayed, printed and transferred to a computer.
The Urispec® Plus is designed for in-vitro diagnostic use (IVD) and should be
used by healthcare professionals, only.
2.1. Intended Use and Indications for Use
The Urispec®Plus is intended for use as an in vitro diagnostic aid using urine
specimens for screening for diabetis metabolic abnormalities, liver diseases,
biliary and hepatic obstructions of the kidneys and urinary tract.
The test provided on Urispec® urine test strips for the determination of specic
gravity, leucocytes, glucose, protein, blood, nitrite, pH, ketones, bilirubin, ascor-
bic acid and urobilinogen are considered routine urinalysis.
2.1.1. Measuring Principle
The test strip moves below a xed measuring head on a slide with an embed-
ded reference pad. The reectometric analysis of the test strip and the reference
eld take place during withdrawal and release of the slide.
Pic. 1: Measuring Principle
The strip is illuminated with an LED and a detector registers the intensity of light
reected by the test strip at three different wavelengths. Using an internal cali-
bration, the results are calculated from the reection values. Whenever samples
are strongly alkaline, a density correction is automatically conducted.
2.1.2. Functional Principle Urispec®Plus
A measurement is started by placing a strip on the holder. If the Autostart-fea-
ture is turned off, the measurement is started by pressing the start panel

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in the display.
The result is shown on the display, printed out and released via the interfaces
after the measurement has been completed. After three minutes the instrument
will go to stand-by. Touching the screen will reactivate the instrument.
All user inputs are performed via the touch-screen (see 3.7. Use of the instru-
ment, page 15).
2.1.3. Safety warnings
The following safety warnings are used throughout the manual:
- DANGER: denes a danger which can result in serious injury or death.
- ATTENTION: denes a possible danger which can result in simple - mild injury.
This symbol is also used to indicate user errors which can result in malfunction
or damage to the device.
- NOTE: provides necessary additional information.

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2.1.4. Labels on the device and symbols
Reflectance photometer for evaluation of
Urispec®11-Way, GP+A, 5-Way Plus and 4-Way
Contents: 1 unit
5701310
SN:
Rev. Date: 12/2018
Made in Hungary
Shelf Box Label for product 5701310
Rev. Date: 12/2018
Made in Hungary
Reflectance photometer for the evaluation of
Urispec®11-Way, GP+A, 5-Way Plus and 4-Way
SN:
Contents: 1 unit
5701309
Reagent test strips for Blood,
Urobilinogen, Bilirubin, Protein, Nitrite,
Ketones, Ascorbic Acid, Glucose, pH,
Specific Gravity and Leucocytes in Urine by the Dip and Read Technique
Contents: 12 packs of 100 strips
11-Way
Distributed by
Shelf Box Label for product 5701309
Rev. Date: 12/2018
Made in Hungary
Reflectance photometer for the evaluation of
Urispec®11-Way, GP+A, 5-Way Plus and 4-Way
SN:
Contents: 1 unit
5701308
Reagent test strips for Blood,
Urobilinogen, Bilirubin, Protein, Nitrite,
Ketones, Ascorbic Acid, Glucose, pH,
Specific Gravity and Leucocytes in Urine by the Dip and Read Technique
Contents: 4 packs of 100 strips
11-Way
Distributed by
Shelf Box Label for product 57001308
9 V / 1.5 A
Type Plate Label

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2.1.5. Symbols explanation
Caution: Further information in user manual
The medical device that has not been subjected to a steril-
ization process.
Keep away from sunlight.
Keep dry.
Temperature limits.
Should not be used if the package is damaged.
The medical device is intended for one use, or for use on a
single patient during asingle procedure.
Indicates the need for the user to consult the instructions
for use.
Do not dispose of the device in common household waste.
Medical device manufacturer.
Manufacturer’s catalogue number.
Manufacturer’s batch code.
Serial number of the device.
Date on which the medical device has been manufactured.
Date after which the medical device is not to be used.
In vitro diagnostic device.
Indicates conformity with health, safety, and environmental
protection standards for products sold within the European
Economic Area
9 V / 1.5A Power input specications.

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3. Unpacking and Set Up
3.1. List of delivered parts
aUrispec® Plus reectometer
b Power pack 100 - 240 V, 47/63 Hz, 9V
cPrinter paper
+ User manual (this booklet)
A
BC
Pic. 2: Content
Read the operating manual for Urispec® Plus carefully before the rst startup in
order to ensure an error free operation.

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3.2. Description of instrument parts
A
B
C
Pic. 3: Front view
DEFG
Pic. 4: Backside view
Actuator Function
1. Touch-Screen Control of equipment functions
2. Test Strip Slide Test strip retainer and autonomous start of analysis
3. Printer Flap Opening the printer ap for paper replacement
4. Serial Interface Connection of a computer
5. USB - Interface Connection of a computer
6. USB - Interface Connection of a keyboard or a bar code scanner
7. Mains Connection Contact for the provided power pack
8. On/Off Switch (I/O) Turning the equipment on and off
9. LAN-Interface Connection to network (serial over LAN), not sup-
ported
3.3. Setting up the instrument
Place the instrument on a hard, even surface where humidity and temperature
are fairly constant. Make sure that the instrument is allowed to acclimate to
room temperature prior to use.
Make sure that you
• Do not place the instrument near strong electromagnetic elds
• Do not place the instrument near heating plates, ovens or radiators
• Do not expose the instrument to strong light sources (i.e. direct sunlight)
H
I

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3.4. How to plug the instrument in
Pic. 5: Power pack Pic. 6: DC in
An adapter is provided for adapting the power pack to the available mains con-
nection. The adapter matching the mains connection is plugged on to the power
pack (Pic. 5). After plugging the power pack cable into the jack "DC in" (Pic. 6)
and connecting the power pack to the power socket the Urispec®Plus is ready
for operation.
3.5. How to load the printer paper
Pic. 7: Printer A Pic. 8: Printer B
Open the printer ap by pressing the rectangular key next to the paper outlet
(Pic. 7).

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Pic. 9: Printer C Pic. 10: Printer D
Unroll the paper roll by 5 cm and place the roll in the paper compartment with
the end on the lower side. Fix the end of the paper to the housing with your
forenger while closing the ap (Pic. 9).
3.6. How to install batteries (optional)
The Urispec® Plus can be operated with 6 type AA batteries independent of the
mains supply. The battery compartment is on the underside of the equipment.
Notice the designated polarity (+/-) marked on the battery compartment while
inserting the batteries.
Pic. 11: Battery compartment
3.6.1. Instrument self test
The Urispec® Plus will perform an automatic self test each time it is turned on.
If an error message appears, the instrument will not start measurements. In this
case, please contact your local service provider.
3.6.2. Calibration
The Urispec® Plus will perform an automatic calibration each time a test is run.

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3.7. Use of the instrument
All user inputs are done via a touch-screen (touch-display). All functions are
activated directly by slight pressure with the nger on explicit pictograms or text
representing the menu items.
3.7.1. Buttons
Framed areas react to pressure and trigger the action linked to it. The caption of
an area describes its function.
Examples:
Conrm / perform action
Cancel action
e.g. display of equipment settings
3.7.2. Scroll Arrows
Press the up-and-down arrows on the right side of the screen to scroll through a
list of information on the left side of the screen. Once the desired information on
the left side is highlighted, press to conrm your selection.
Strip
Password
Printer
Sound
Autostart
Battery
Language
Date/Time
Interface
SETTINGS
Display 3: Selective lists
Pressing will select the highlighted line. You can leave the menu by pres-
sing .

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3.7.3. Round buttons
These buttons typically appear on screens that require a selection among serial
items. The button with a lled circle is the current selection.
DAY
Today
All
Date
Pressing the circle will activate a selection. Save your selection by pressing
. Pressing will quit the menu without performing any changes.

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4. User Menu
4.1. Flow-chart of the Menu Structure
SN:
ID:
(P)
Memory List
Search
Clear
Check mode
Settings
Memory
Measurement
Type
Units
Strip
Parameter order
Password
Sound Touch
Positive
Battery Backlight
Printer
Printer
Autostart
Language
Date/Time
Interface
Customisation
Print setting

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4.2. Description of the Menu Items
• SN:
5.6. Changing the sequence number ("SN")
• ID:
5.5. Entering the Patient Identication
• (P):
Standby
• :
Main menu
• Memory:
7. Recall results
• Check mode:
9. Quality control testing
• Settings:
10.1. How to modify strip settings
10.2. How to protect settings from unauthorized access
10.3. How to turn the printer on and off
10.4. How to enable and disable acoustic signals
10.5. How to deactivate and activate the autostart
10.6. How to set energy saving options for the battery mode
10.7. How to change the language
10.8. How to set time and date
10.9. How to activate data transfer
10.11. How to print settings10. How to change the text of the printout header
10.10. How to change the text of the printout header

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5. Analysis of Test Strips
Note: The Urispec®Plus will perform an automatic calibration each time a test
is run.
5.1. Select strip
The Urispec®Plus reader can read different test strips. Upon turning on the
instrument, the display will show all available strips. Select the strip you want to
use and press .
NOTE: If you do not make a choice, the reader will start with the preselected
strip after approx. 15 seconds.
NOTE: The strip selection screen only appears when the reader is turned on.
If you want to change to a different strip type, turn the instrument off and turn
it on again. Then make your choice.
5.2. How to perform a measurement
The Urispec® Plus is very easy to use. In order to start the measurement, the
test strip is placed on the strip holder. The instrument automatically detects a
new strip and starts the measurement. A progress bar appears, that indicates
the remaining analysis time. After 30 seconds the test strip is drawn into the
instrument, after 60 seconds it is released.
NOTE:
Make sure to remove excess urine by blotting the test strip carefully on a lint-
free cloth.
NOTE: If "Autostart" is deactivated, the measurement must be started using
the start control panel (see 10.5. How to deactivate and activate the
autostart, page 32).
After the measurement, the instrument will release the analysed test strip which
can now be discarded. The result is displayed on the screen and is transferred
via the interfaces and / or printed according to equipment settings.
For additional information on the test strip, please read the package insert that
comes with the strips.
DANGER:
Urine and used test strips bare the danger of infection. Always use protective
gloves during handling and disposal. The disposal of used test strips should
be performed according to the regulations for the handling of potentially infec-
tious material.

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5.3. Display of Results
The sequence number (Seq.No.) as well as the patient identication (ID) will be
displayed with the results.
RESULT
Seq.No: 0001
ID: 1234567890
2006.02.17 9:47
*BLD 10 ERY/uL
UBG NORM
BIL NEG
PRO NEG
NIT NEG
KET NEG
*GLU 50 mg/dL
pH 5.0
SG 1.005
LEU NEG
Display 4: Result
Positive ndings are clearly marked by an asterisk (*) on the printout and on the
display. Additionally, it is possible to enable an acoustic signal on positive nd-
ings.
The printout is light-sensitive and may turn yellow when exposed to light during
storage. For archiving purposes the printouts should be kept in a dark place
(patient le) or as a photocopy.
The result displayed may be printed again by pressing . The return panel
will lead back to the start screen.
5.4. Measurement Errors
If the display shows "Measuring Error ..." instead of a result please read the
instructions (see 15. Error Messages and Fault Clearance, page 39).
Repeat the measurement. In case of permanent errors please contact HENRY
SCHEIN service.
5.5. Entering the Patient Identication
The patient identication needs to be entered before starting the analysis. This
can be done as follows:
a) Directly on the equipment: Pressing
ID:
in the start menu brings up an al-
phanumeric keypad. Enter the ID using the keys. To enter characters (i.e.
"Miller”) press ABC to change the character entry. Repeated pressing on the
same eld within 0.5 seconds switches through the characters displayed on
the key. Wrong entries may be erased by pressing .