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Systemsure Plus and Ensure Operator Manual V5.0: Ins0228 July 2020

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0% found this document useful (0 votes)
90 views34 pages

Systemsure Plus and Ensure Operator Manual V5.0: Ins0228 July 2020

Uploaded by

Ajie Jabriex
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 34

SystemSURE Plus and EnSURE™

Operator Manual
V5.0

I INS0228 July 2020


This Manual Copyright © 2020 by Hygiena LLC
All rights reserved. No part of this manual may be reproduced, stored
in a retrieval system, or transmitted, by any means or in any form,
without the prior permission of Hygiena LLC.
The information contained in this manual is subject to change without
notice. Hygiena LLC assumes no responsibility for any errors that may
appear in this document.
This manual will describe the specifications and general operations of
the SystemSURE Plus v2 and EnSURE v2 luminometers.
For older luminometers, refer to the operator’s manual that shipped
with the luminometer for specific operations.
Document: SystemSURE Operators Manual
Copyright, Trademarks and Patents
Hygiena™, EnSURE™, UltraSnap™ are trademarks of
Hygiena, LLC.
A list of Hygiena patents can be found at:
https://www.hygiena.com/patents.html
Operating Precautions and Limitations of Use

IMPORTANT
Hygiena’s products are designed and constructed to be safe
and without risk to health when properly used in accordance
with the supplied documentation and when the operating
precautions outlined in this manual are fully observed.
It is essential that the user of this manual is aware of the
potential hazards associated with the unit and its accessories
All operators should be familiar with the safety precautions
and warnings given in this manual before attempting to
operate the unit.
If the unit is used in a manner which is not specified by the
manufacturer, the protection provided by the equipment may
be impaired.
Please read this manual in its entirety and the “Operating
Precautions and Limitations of Use” at the end of the manual
before using the Luminometer.

The following symbol is used in this manual:


Description: CAUTION / WARNING

II INS0228 July 2020


Table of Contents
1. INTRODUCTION _____________________________________________________ 1
1.1 WHAT IS ATP? _____________________________________________________ 2
1.2 HOW DOES THE LUMINOMETER WORK?____________________________________ 2
1.3 WHAT IS AN RLU? __________________________________________________ 2
1.4 TEST DEVICES AND ACCESSORIES _________________________________________ 3
2. LUMINOMETER DESCRIPTION __________________________________________ 4
2.1 KEYPAD SYMBOLS ___________________________________________________ 4
2.2 INSTALLING BATTERIES ________________________________________________ 5
2.3 TURNING THE LUMINOMETER ON AND OFF __________________________________ 6
2.4 DISPLAY LAYOUT AND ICONS ____________________________________________ 7
2.5 LOW BATTERY INDICATOR ______________________________________________ 7
2.6 POWER SAVING STANDBY MODE _________________________________________ 8
2.7 INTERNAL CALIBRATION _______________________________________________ 8
2.8 LOW MEMORY WARNING _____________________________________________ 8
3. SET-UP MENU OPTIONS_______________________________________________ 9
3.1 USER ID _________________________________________________________ 10
3.2 SETTING UP PROGRAM TEST POINTS AND PASS/FAIL LIMITS _____________________ 10
3.3 TEST PLANS ______________________________________________________ 11
3.4 ESTABLISHING ATP PASS/FAIL LIMITS ____________________________________ 12
3.5 VIEWING STORED TEST RESULTS ________________________________________ 12
3.6 VIEWING STATISTICAL DATA AND TEST FAILURES _____________________________ 12
3.7 ERASING THE TEST RESULTS MEMORY ____________________________________ 13
3.8 SETTING THE CLOCK TIME AND DATE _____________________________________ 13
3.9 ADJUSTING THE LCD CONTRAST ________________________________________ 14
3.10 QUICK BOOT ____________________________________________________ 14
3.11 STANDBY MODE __________________________________________________ 14
3.12 BOLD TEXT ______________________________________________________ 15
3.13 SAVE TESTS _____________________________________________________ 15
4. SAMPLE MEASUREMENTS AND TEST RESULTS ___________________________ 17
4.1 TAKING A SAMPLE MEASUREMENT ______________________________________ 18
4.2 PERFORMING A RETEST ______________________________________________ 19
5. INSTALLING SURETREND DATA ANALYSIS SOFTWARE _____________________ 19
5.1 CONDITIONS OF USE ________________________________________________ 19
5.2 HARDWARE AND SOFTWARE REQUIREMENTS _______________________________ 20
5.3 STARTING THE INSTALL PROCESS ________________________________________ 20
5.4 USING THE SURETREND SOFTWARE ______________________________________ 20
5.5 INSTALLING THE USB SMART CABLE DRIVER ________________________________ 21

III INS0228 July 2020


5.6 CONNECTING THE LUMINOMETER TO THE PC________________________________ 22
6. OPERATOR MAINTENANCE ___________________________________________ 22
6.1 CLEANING THE LUMINOMETER CASE _____________________________________ 22
6.2 REPLACING THE BATTERIES ____________________________________________ 22
6.3 CLEANING AND REPLACING THE PROTECTIVE POCKET __________________________ 23
7. TROUBLESHOOTING ________________________________________________ 24
7.1 LUMINOMETER BEEPS _______________________________________________ 24
7.2 TROUBLESHOOTING TIPS _____________________________________________ 24
7.3 LUMINOMETER ERROR CODES __________________________________________ 26
8. UNIT WARRANTY AND RETURNS ______________________________________ 27
8.1 WARRANTY DURATION ______________________________________________ 27
8.2 PARTICULAR EXCLUSION ______________________________________________ 27
9. GLOSSARY OF TERMS AND ABBREVIATIONS _____________________________ 27

10. TECHNICAL SPECIFICATION __________________________________________ 28

11. CAUTIONS AND WARNINGS _________________________________________ 29

IV INS0228 July 2020


1. Introduction
The luminometer is part of an ATP Hygiene/Sanitation Monitoring
System intended to detect ATP found in organic matter and
microorganisms. The Hygiena luminometer, in conjunction with
Hygiena’s ATP and Micro-snap test devices, measures levels of
contamination on surfaces, water and product samples.

1. Remove swab from test tube and collect sample. Refer to


instructions included with testing device.
2. Place swab back in test tube.
3. Break Snap Valve at top of swab by bending bulb. Squeeze
bulb twice, pushing liquid reagent down swab shaft.
4. Shake test for 5 seconds.
5. Place test in the luminometer and close lid.
6. Hold the luminometer upright and press “OK”. Reading will
appear in 15 seconds.

1 INS0228 July 2020


1.1 What is ATP?
Adenosine Triphosphate (ATP) is an
organic molecule that is used by living
cells as the main source of energy.
Animal, plant, bacterial, yeast, and mold
cells produce and break down ATP in order
to drive a number of biological processes.
It is the main energy-transfer molecule in
the cell. The presence of ATP on a surface indicates that the surface
has not been adequately cleaned and has the potential to harbor and
support bacterial growth. The residue may also contain hazardous
material including potential allergens. Therefore, ATP is an ideal
indicator of surface cleanliness.
1.2 How Does the Luminometer Work?
The luminometer detects ATP using a chemical reaction.
Luciferin/Luciferase + ATP = Light
A sample is collected using a Hygiena ATP device (see section 1.4).
Surface tests come with a buffer moistened swab bud that aids in the
removal of any biological material (ATP) on either a wet or dry
surface. Once the sample is collected and exposed to the chemistry
(buffer) in the Hygiena device, the ATP contained inside the collected
cells will be released. ATP released from inside these cells, along with
any free ATP picked up from the surface by the swab, is now available
to react with the chemistry in the bulb of the device. When the
Luciferin/Luciferase enzymes are exposed to ATP, light is produced.
The light is detected and measured by the luminometer. The amount
of light detected is directly proportional to the quantity of ATP
collected and accordingly is proportional to the amount of residue in
the tested sample. The higher the reading, the higher the amount of
contamination in the sample.
1.3 What is an RLU?
The luminometer displays results in Relative Light Unit (RLU) values.
The light produced from the Luciferin/Luciferase and ATP reaction in
the swab is emitted in the form of photons. A photon is an elementary
particle and the basic unit of light. The luminometer detects these
photons and displays them directly as RLU values. The more light
detected by the luminometer, the greater the RLU value. The
quantitative RLU reading is then compared against user
programmable thresholds to provide an overall qualitative pass ,
caution or fail result.
The luminometer detects total ATP, not just ATP from bacteria, yeast,
and mold but also the ATP from anything organic in the sample.

2 INS0228 July 2020


Therefore, an RLU value is not the same as a microbial colony forming
unit (CFU). Since the luminometer is detecting total ATP, it is unknown
whether the RLU result displayed by the luminometer is due to the
detection of microbial ATP, residual ATP, or a combination of both.
Therefore, a comparison cannot be drawn between RLU values from
ATP and standard plate counts (SPC); or rather RLU does not equal
CFU. True microbial contamination can only be determined by a
standard plate count method that can take up to 48 hours for results.
The luminometer is capable of providing results in 15 seconds offering
a rapid, real-time approach to hygiene/sanitation monitoring. The
luminometer is not meant to replace microbial testing. It can be an
effective tool when incorporated into a Hazard Analysis Critical Control
Point (HACCP), Good Manufacturing Practices (GMP), or sanitation
plan.

1.4 Test Devices and Accessories


Device Cat No. Description
UltraSnap US2020 Surface total ATP test device
SuperSnap SUS3000 High sensitivity total ATP test suited
for allergen prevention applications
AquaSnap Total AQ100X Water total ATP test device
AquaSnap Free AQ100FX Water Free ATP test device
Contamination CCK-4 Cuvette based water testing kit
Control Kit
MicroSnap MS-EB Enterobacteriaceae test
Enterobacteriaceae
MicroSnap MS-COLIFORM Coliform test
Coliform Test
MicroSnap E. coli MS-ECOLI E. coli test
Test
MicroSnap Total MS-TOTAL Total Viable Count test
ZymoSnap ALP ZS Alkaline Phosphatase test
CrossCheck CX3000 Acid Phosphatase test
Calibration Kit PCD4000 Positive and negative rod for
validating luminometer calibration
ATP Positive CK25 25 vials of freeze-dried ATP to verify
Control Kit efficacy of ATP test devices

See the Hygiena website for a complete list of test devices,


accessories, and other products. www.hygiena.com

3 INS0228 July 2020


2. Luminometer Description
Luminometer components:

2.1 Keypad Symbols


The keypad is arranged with the following buttons:
Power on/off button
Menu select and Exit button
Up/increase button
Start/accept button
Down/decrease button
Program select button
Statistics shortcut button

The functions of the keypad are explained in detail in the following


sections of this manual.
TIP: Pressing and holding down the or button will make it auto-
repeat. The longer the buttons are held down, the faster it goes.

4 INS0228 July 2020


Opening the lid reveals the following internal features:

RS232 connector cover

Protective pocket and


sample insertion port

For details on the RS232/USB connector and protective pocket, refer


to sections 5.6 and 6.1 respectively.
2.2 Installing Batteries
The unit is designed to operate from both non-rechargeable alkaline
batteries and rechargeable Nickel Metal Hydride (NiMH) or Nickel
Cadmium (NiCD) batteries:
Battery Nominal Relative
Technology Cell Voltage Capacity
Alkaline 1.5V 1.0
NiMH 1.2V 0.6
NiCD 1.2V 0.5
The unit requires two batteries of size AA, LR6 or E91.
TIP: For best results, always use a quality brand of Alkaline battery
and replace as soon as the batteries become low (see section 2.5).
WARNING: Do not mix batteries of different technologies, or use
recharged alkaline batteries as these are prone to overcharging and
leaking, which may cause permanent unit damage and malfunction.
The batteries are fitted by unclipping the battery cover on the back of
the unit, and inserting both batteries with their positive terminals 
pointing towards the top of the unit.
CAUTION: Take care not to insert the batteries in the wrong
direction, as this may cause permanent damage to the unit’s internal
electronics.

5 INS0228 July 2020


When the batteries are inserted correctly, the unit will automatically
turn on and enter the clock set-up mode. (see section 3.8).
2.3 Turning the Luminometer On and Off
To turn the unit on, press the button. The unit
will beep once and display the power-up self-
check screen:
NOTE: If the batteries are too low, the unit may
turn on and back off again automatically, or may
not turn on at all. If this happens, replace the
batteries immediately.
The unit will then perform an internal 15 second
calibration (see section 2.7).
NOTE: If the clock is not set, the unit will automatically enter the time
and date set-up mode (see section 3.8) before performing its
calibration.
TIP: It is recommended you synchronize the unit after changing the
batteries before use. This will allow SureTrend software to set the
date, time, and format to the computer’s date, time, and format.
TIP: To activate the backlight features press and hold down the
button. The backlight uses more power and will drain the battery
faster.
To turn the luminometer off, press the button. The luminometer
will beep once and the display will go blank.
NOTE: To avoid accidental turn off, the button is disabled when
the luminometer is performing a sample measurement.

6 INS0228 July 2020


2.4 Display Layout and Icons
The liquid crystal display (LCD) has the following
layout. The upper half of the display contains the
status icons and the large RLU result digits.
The following is a list of icons and their definitions.

Low battery warning icon


Lid icon - flashes when the lid needs to be closed, or the
RS232 connector cover needs to be properly tucked under
the lid
Insert icon – arrow flashes when the testing device should
be inserted
Remove icon – arrow flashes when a testing device needs
to be removed
Pass result icon

Caution result icon

Fail result icon

Sample measurement reading in Relative Light Units (RLU)


Retested icon – identifies the failed test result as having
been retested (see section 4.2)
Retest result icon – identifies the Program location or test
result as a retest result
2.5 Low Battery Indicator
The low battery icon indicates the state of the batteries:
Icon Battery State
Not visible Good
Visible Low – replace batteries soon
Flashing Flat – replace batteries now!

When the batteries are completely low, the luminometer will flash the
icon, beep three times, and automatically turn off.
CAUTION: Never leave low batteries in the luminometer, as they
are prone to leaking/corrosion, which will damage the luminometer.
TIP: Always store the luminometer in a cool dry place when not in
use because elevated temperatures will shorten the battery life.

7 INS0228 July 2020


2.6 Power Saving Standby Mode
If the luminometer is on but has not been used for 19 minutes, it will
beep every 10 seconds for 1 minute, and then turn off. If any key is
pressed during that time the luminometer will reset the Standby Mode
countdown. The Standby Mode settings can be changed (see section
3.11).
To turn the luminometer back on, simply press the button.
2.7 Internal Calibration
When the luminometer is turned on (see section
2.3), it performs an internal calibration, as the
display counts down from 15 to 0 seconds.
NOTE: During the calibration sequence, there must
not be a testing device in the luminometer and the
lid must remain closed. If the icon is shown with the arrow flashing,
open the lid and remove the testing device from the luminometer. If
the icon is flashing, close the lid. If it is still flashing, make sure the
rubber flap covering the RS232 port is tucked under the lip and is flat.
TIP: The button can be pressed at any time to access the set-up
menu options (see section 3).
When the calibration is complete, the luminometer is ready to perform
a sample measurement.
For details of how to perform a sample measurement
refer to section 4.
NOTE: When the luminometer is ready to perform a
measurement, with the lid closed and no testing
device present, the luminometer will automatically
perform a recalibration cycle under any of the following
circumstances:
• The user presses and holds down the button for 1 second.
• The luminometer is used in an environment where the
temperature changes significantly (typically more than +/-5oC).
2.8 Low Memory Warning
The luminometer can store up to 2000 test results
in its internal memory. When the memory is more
than 95% full (i.e. less than 100 tests remaining)
the following warning symbol is displayed.
When the memory becomes completely full, no
additional tests can be performed until the memory is either erased
or uploaded to the PC (see sections 3.6 and 5 respectively). Test can
be performed if Save Test is turned off (see section 3.13)

8 INS0228 July 2020


3. Set-up Menu Options
With the luminometer turned on, the Set-up Menu can be accessed
by pressing the button.
Use the and buttons to scroll through the menu list, and then
press the button to select the required menu option, or the
button the exit the menu.
The following 11 menu options are available:

User ID

Test Plan

Program

Statistics

Memory

Clock

LCD Contrast

Quick Boot

Standby Mode

Bold Text

Save Tests

9 INS0228 July 2020


NOTE: SureTrend software is required for sections 3.1 to 3.3. For
further details, refer to the separate SureTrend User's Manual located
on the SureTrend software CD that is packaged with the luminometer.
3.1 User ID
The luminometer can store a list of 201 User IDs (User: 0 to 200).
Each test result will be tagged with the currently selected User ID.
Select the User ID menu option, then use the and buttons to
scroll through the list of User IDs, then press the button to select
a User ID, or the button to cancel the selection.
TIP: User:0 is the default selection if no User ID list has been
defined.
3.2 Setting up Program Test Points and Pass/Fail Limits
The luminometer has the ability to store a list of 5001 unique Program
test points (Prog# 0 to 5000), each with its own upper () and lower
() pass/fail result threshold values.
Program test point location names can only be programmed into the
luminometer through the SureTrend software. Program pass/fail
thresholds can either be set-up on the luminometer, or set using the
SureTrend software. If a location name is entered and threshold set
in SureTrend, and then downloaded to the luminometer, the threshold
values can’t be changed via the luminometer. This is a security feature
and prevents inadvertent changes to the thresholds after being set in
SureTrend.
TIP: Prog:0 has a special function, whereby the threshold values
defined for Prog:0 are used as the initial values when setting-up the
other Prog thresholds. Setting Prog:0 with your typical threshold
values will save time when setting-up the other Programs. The
luminometer comes with pass/fail thresholds of 10 RLU for pass and
30 RLU for fail. These pass/fail thresholds were determined based on
a comprehensive study of ATP, food residue, and microorganism
samples. To receive the report or more information on setting up
pass/fail thresholds contact Hygiena or visit our Question and Answer
section at www.hygiena.com.
To set the Program result thresholds on the luminometer, first select
the PROGRAM menu option by pressing . Scroll to “PROGRAM” and
press . Then use the and buttons to scroll through the list of
Programs, followed by the button to select the Program to be
changed:

10 INS0228 July 2020


Prog:

Next use the and buttons to first change the value of the upper
threshold (), followed by the button; to select the lower threshold
use (). Use the and buttons to change the lower value, followed
by the button to store the new values:
upper threshold ()

lower threshold ()

NOTE: If the selected Program location does not have any thresholds
defined, it must be set-up using the PROGRAM menu option before
the Program can be used.
3.3 Test Plans
The luminometer can also store up to 100 individual Test Plans. Each
Test Plan can contain a list of up to 251 test locations, specified in the
order in which they would normally be tested.
Having selected the TEST PLAN menu option, use the and
buttons to scroll through the list of Test Plans, and then press the
button to select the new Plan, or the button to cancel the selection.
TIP: Plan:0 allows any of the 5001 test locations to be tested in any
order, and is the default selection if no Test Plans have been defined
or selected.
An example set of Test Plans for a typical week might be:
Plan: 1 Plan: 2 Plan: 3 Plan: 4 Plan: 5
Monday Tuesday Wednesday Thursday Friday

Prog:1 Prog:1 Prog:2 Prog:3 Prog:4


Prog:2 Prog:7 Prog:8 Prog:9 Prog:5
Prog:3 Prog:6 Prog:5 Prog:4 Prog:6
Prog:7 Prog:10 Prog:9
Prog:8 Prog:8
Prog:9 Prog:7
Prog:6 Prog:3
Prog:5 Prog:2
Prog:4 Prog:1
Prog:10

11 INS0228 July 2020


Test Plans are defined by using the SureTrend Windows software.
Please refer to the SureTrend User’s Manual located on the SureTrend
software CD for full details (see section 5).
To select a Test Plan, use the TEST PLAN menu
option.
NOTE: If Test Plan Plan:0 is selected, or no Test
Plans have been defined, any of the 5001 Program
locations can be selected.
To select a Program location press the button,
then use the and buttons to change the Program Prog: to the
desired Program location, followed by the button to accept the new
location, or the button to cancel the selection.
TIP: When selecting a Prog:, the display also shows the time and
date that the Program location was last tested.
3.4 Establishing ATP Pass/Fail Limits
For instructions on establishing Pass/Fail limits, refer to the
implementation guide included with your system, or visit the
resources available on www.hygiena.com.
3.5 Viewing Stored Test Results
The luminometer can store a maximum of 2000 test
results in its internal memory, even when the
batteries are low or removed.
To view these stored test results, select the
MEMORY menu option by pressing the button. Scroll to “MEMORY”
and press . Then use the and buttons to scroll through the test
results, pressing the button to exit:
TIP: After reviewing the stored test results, a failed Program
location can be selected for retesting by pressing the button (see
section 4.2).
3.6 Viewing Statistical Data and Test Failures
The test results database can be analyzed by
selecting the STATISTICS menu option by pressing
the button. Scroll to “STATISTICS” and press .
This will display a simple comparison of all the stored
results. The button also provides a direct shortcut
to this function.
The and buttons can then be used to scroll through all of the
failed test results. Press the button to exit.

12 INS0228 July 2020


3.7 Erasing the Test Results Memory
WARNING: Once the test results have been erased
from memory they are permanently deleted and can
no longer be viewed or uploaded to SureTrend.
NOTE: Once started, the erase function cannot be
stopped, and will take about 30 seconds to erase a
full 2000 results.
The entire test results memory can be cleared using the MEMORY
ERASE function, by first selecting the , then using the up or down
arrows to select the MEMORY menu option, then press to select,
and then pressing and holding down the button for 2 seconds. The
display will show the total number of stored results to be erased. To
accept and start the erase function, press and hold down the button
for 1 second, or press any other button to exit the option.
3.8 Setting the Clock Time and Date
To set or change the clock time, date, and format, select the CLOCK
menu option by pressing the button. Scroll to “CLOCK” and press
. Then use the and buttons to change the time and date value,
followed by the button to accept each new value.
First the time is set (style  hours  minutes), which can be configured
as either a 12-hour clock (select AM or PM) or a 24-hour clock (select
24H):
AM, PM or 24H
hours
minutes

Next set the date format, which can be configured for either European
format, select D/M/Y for day, month, year, or American format,
select M/D/Y for month, day, year):
D/M/Y or M/D/Y
day (D/M/Y) or month (M/D/Y)
month (D/M/Y) or day (M/D/Y)
year

TIP: Pressing the button at any point will exit the clock set-up
mode, leaving the time and date unchanged.
NOTE: The clock does not have automatic daylight saving
adjustment. If this is required, the time must be manually changed
when necessary.

13 INS0228 July 2020


3.9 Adjusting the LCD Contrast
The contrast of the LCD screen is factory set at its optimum level for
normal operating conditions. However, in extremes of temperature
the display may appear too dark or light.
This setting can be manually adjusted by selecting the LCD
CONTRAST menu option by pressing the button. Scroll to
“CONTRAST” and press . Then use the or button to increase or
decrease the contrast level, followed by the button to store the new
setting:

darker (+1 to +5)


Normal (0)
lighter (-1 to -5)

3.10 Quick Boot


The luminometer will turn on when you press the button. The
luminometer will perform a standard calibration in 15 seconds and will
then be ready to perform readings. Quick Boot can be turned off and
the luminometer will perform a more in-depth system check the next
time it is turned on. The more in-depth system check takes 60
seconds.
NOTE: The more in-depth system check is typically used for
diagnostic purposes and not necessary for normal use.
To change the Quick Boot setting, select the QUICK BOOT menu
option by pressing the button. Scroll to “QUICK BOOT” and press
button to switch between ON and OFF:

OFF
ON
Exit

3.11 Standby Mode


The Standby Mode is used to control when the luminometer should
automatically turn off when not in use. This is designed to conserve
battery power.
The default is 20 minutes. If no buttons are pressed within the time
period, the luminometer will turn off. If any button is pressed, or a
reading is performed, the Standby Mode countdown timer is reset to
zero.

14 INS0228 July 2020


If the bell icon is enabled the luminometer will begin beeping every
10 seconds for 1 minute as a warning before turning off. For example,
if the Standby Mode time is set to 20, then if the luminometer is not
used for 19 minutes it will start to beep every 10 seconds for 1 minute.
If no action is taken the luminometer will turn off. If any button except
the power button is pressed the countdown will restart.
To change the Standby Mode setting, select the STANDBY MODE
menu option by pressing the button. Scroll to “STANDBY MODE”
and press button. Then use the or button to increase or
decrease the Standby Mode duration, followed by the button to
store the new setting. Standby Mode duration can be from 5 to 60
minutes in increments of 5 minutes. Then use the or button to
enable or disable the warning beeps. This will toggle the bell icon from
enabled to disabled . Press the button to accept the settings:

increase or decrease duration (5 to 60)


set duration
enable or disable warning beeps
set warning state

3.12 Bold Text


The luminometer displays key information on the LCD in bold to
improve legibility. In some cases the number and size of the text will
exceed the allotted space on the LCD. If bold is set to OFF all text on
the luminometer will be displayed normally. This will allow all text to
be displayed even if the text is maximum and all wide characters.
To change the Bold Text setting, select the BOLD TEXT menu option
by pressing the button. Scroll to “BOLD TEXT” and press button
to switch between ON and OFF:

OFF
ON
Exit

3.13 Save Tests


By default any test performed on the luminometer is recorded to the
luminometer’s non-volatile memory. Even if you take the batteries out
the results of the test are retained in the luminometer’s memory.

15 INS0228 July 2020


In some cases, such as training, calibration checks, etc. users may
want to discard test results. If Save Test is set to OFF, all tests taken
in this mode will not be recorded.
NOTE: The Save Tests mode will be set back to ON
when the luminometer is turned off and back on
again. When Save Tests mode is set to OFF
“RESULTS NOT SAVED” will appear at the bottom of
the LCD
To change the Save Tests setting, select the SAVE TESTS menu
option by pressing the button. Scroll to “SAVE TESTS” and press
button to switch between ON and OFF:

OFF
ON
Exit

16 INS0228 July 2020


4. Sample Measurements and Test Results
With the luminometer turned on, and having completed its internal
calibration self-checks, it is ready to perform a new sample
measurement, and the display shows the following details:

Various keypad options are now available, as detailed in each of the


following sections:
Button Action Section

Access set-up menu options 3

Select different User ID 3.1

Select program number 3.2

Select different Test Plan 3.3

Perform calibration 2.7

Start new measurement 4.1

View previous test results 3.5

Show statistical result data 3.6

Turn luminometer off 2.3

17 INS0228 July 2020


4.1 Taking a Sample Measurement
IMPORTANT: Please refer to the testing device data sheet and kit
insert for full details on how to use the testing device.
NOTE: Always allow the luminometer sufficient time to acclimatise to
any change in environment, temperature or humidity before taking
sample measurements.
To perform a sample measurement, follow the steps below:
1. Swab the sample area and activate the
testing device. (see kit insert for details)
2. Open the luminometer lid, insert the testing
device into the luminometer, and close the
lid.
3. Holding the luminometer upright, press the
button and wait 15 seconds for the result
to be displayed.

WARNING: Always ensure that the exterior of the testing device


is clean and dry before inserting it into the luminometer. Never insert
anything other than a Hygiena testing device into the luminometer.
Never insert a device into the luminometer when the protective pocket
is removed (see section 6.3).
While the measurement is being performed, the display counts down
from 15 to 0.
NOTE: For consistent results, always keep the luminometer upright
and steady while it is performing a measurement to ensure that the
liquid in the testing device is at the bottom of the tube.
When the measurement is complete, the RLU test result and overall
pass/caution/fail result are displayed:

TIP: A failed test result can be selected for retesting by pressing


the button, followed by the button to select the Program location
(see section 4.2).

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Now remove the testing device and dispose of it. Previous test results
can be viewed by pressing the and buttons (see section 3.5), or
the results statistical data can be obtained by pressing the button
(see section 3.6).
TIP: The luminometer can be recalibrated by removing the testing
device, closing the lid and then pressing and holding down the
button for 1 second. The luminometer will then perform a 15-second
zero measurement.
4.2 Performing a Retest
When viewing a failed test result (see sections 3.5
and 4.2), the program location can be selected for
retesting by pressing the button, followed by the
button:
NOTE: It is only possible to select a program location
for retest if the most recent test result for that location was a failure
.
Having selected retest mode (signified by the icon next to the
Prog:, perform the sample measurement in the usual way, using a
new testing device. (see section 4.1).
Once the retest measurement is complete, the original failed test
result is marked with the icon, and the new test result is tagged
with the icon:

NOTE: Retest mode is automatically deselected once the new


measurement is complete, or can be manually cancelled by pressing
the button and selecting a new program location.
5. Installing SureTrend Data Analysis Software
The test results stored in the luminometer's memory can be uploaded
to a PC using the SureTrend Data Analysis software. The software is
supplied on the CD with the luminometer.
5.1 Conditions of Use
As Hygiena LLC has no control over the specification, state or use of
any computer equipment on which this software is installed or used,
the following Conditions of Use apply.

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IMPORTANT
The software is provided “as is” without warranties of any kind
either expressed or implied including warranties of
merchantability or fitness for a particular purpose. Hygiena LLC
shall not be liable for any loss of profit, loss of use, loss of
software, loss of data, interruption to business, nor for indirect,
special, incidental or consequential damages of any kind whether
under this agreement or not.

5.2 Hardware and Software Requirements

COMPONENT REQUIREMENT
Pentium series processor or higher. x86
Processor
(32-bit) and x64 (64-bit) supported
Memory 256 megabyte (MB) RAM or higher
Hard disk 600 megabytes (MB) of free space.
Microsoft Windows XP with Service Pack
Operating system (SP2),
Windows Vista, Windows 7, Windows 8
Communication USB or Serial RS232 port
5.3 Starting the Install Process
NOTE: If you have a previous version of the SureTrend software on
your PC, it is recommended that you make a backup of your data.
SureTrend software install will try to locate the previous version of
SureTrend and perform an upgrade. If you have an old version of
SureTrend or dataSURE a new installation will be created.
The software is installed onto your computer by inserting the
SureTrend CD that comes with the luminometer into your CD drive
and following the installation script screen prompts. If the install script
does not automatically start, the “Auto Run” feature on your computer
has been disabled. Open My Computer, right-click on the CD drive
and select AutoPlay. If this does not start the install program open
the CD folder and run the Setup application.
NOTE: You must have appropriate privileges to install software on
your computer. If you do not have sufficient permissions the software
will not install.
5.4 Using the SureTrend Software
The user manual for SureTrend Data Analysis is delivered in soft copy
only. The user manual can be found on the SureTrend software CD.
The soft copies are in PDF and XPS formats. In order to view or print
these documents you will need to install Adobe Acrobat Reader or

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Microsoft XPS viewer. If you are running Windows 7 or later the
Microsoft XPS viewer is already installed.
5.5 Installing the USB Smart Cable Driver
If your luminometer came with a USB to RS232 cable you need to
install the SystemSURE USB Smart Cable device driver. The device
driver should be installed when you install the SureTrend software.
(see section 5.3). However, if needed, you can follow the instructions
below to install the SystemSURE USB Smart Cable device driver.
1. Insert the Smart USB cable into an available USB port on
your computer. If the cable is already connected to your
computer, remove the cable and plug it in again. This will
cause Windows to detect the new hardware and start the
“Found New Hardware Wizard”.
2. If the “Found New Hardware Wizard does not start check the
following:
a. You have sufficient permissions to run the wizard.
b. Verify there are no existing hardware problems in
device manager.
c. Verify the Universal Plug and Play service is
running.
3. Follow the “Found New Hardware Wizard” steps to install the
device driver.
4. If your computer is connected to the Internet and you are
running Windows 7 or a later version, you can search the
Microsoft Windows Update site for the device drivers.
5. If your computer is NOT connected to the Internet or you are
running Windows XP you need to place the SureTrend
software CD into an available drive. The Smart USB Cable
device drivers are located on the CD. Instruct the “Found
New Hardware Wizard” to search the CD when prompted.
NOTE: the USB drivers are Windows certified for Windows XP,
Windows Vista, Windows 7, and Windows 8.

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5.6 Connecting the Luminometer to the PC
Now connect the serial interface cable (as supplied with the
luminometer) between the luminometer and one of the RS232 or USB
ports on your PC:
Step 1 Step 2 Step 3

OR

Fold back rubber Insert small RJ10 plug Connect other end to
cover to access into luminometer’s the PC’s COM port or
RS232 socket RS232 socket USB port depending on
the Cable included with
your luminometer.

NOTE: Select the appropriate RS232 or USB cable most suitable for
your PC. A USB-to-RS232 adapter can also be used. Please contact
your local distributor for further details.
6. Operator Maintenance
The luminometer does not require any specific routine operator or
service engineer maintenance.
6.1 Cleaning the Luminometer Case
Clean the luminometer case when required using a dry or slightly
damp cloth only.
WARNING: Never clean the luminometer using a wet cloth or
washing it with water.
CAUTION: Do not use solvents or other strong cleaning solutions
as these may attack and deform the luminometer’s plastic
components, and seriously degrade its performance.
6.2 Replacing the Batteries
For best results, the batteries should be replaced when the low battery
warning icon is flashing.
For details on how to fit new batteries (see section 2.2). Take care
not to mix the old batteries with the new ones.
IMPORTANT: Always dispose of old batteries in accordance with your
local authority regulations.

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6.3 Cleaning and Replacing the Protective Pocket
WARNING: Always turn off the luminometer before removing the
protective pocket.
The luminometer is designed with a special protective pocket, which
can be removed for cleaning or replacement if required. To remove
the protective pocket, open the luminometer’s lid, tightly grasp the
finger grip of the pocket, gently pull the pocket upwards, and remove
it from the luminometer.

(1) Grasp finger (2) Pull pocket (3) Remove pocket


grip upwards

CAUTION: Great care should be taken when removing the pocket


not to damage it or the surrounding casework. Do not use excessive
force. Never use a tool to pry out the pocket.
Carefully clean the interior of the pocket using water or a very mild
detergent solution, ensuring that the pocket is completely dry and
clean before putting it back into the luminometer.
WARNING: Do not use solvents or other strong chemicals as
these will degrade the clear optical section of the pocket and affect
the performance of the luminometer.
To replace the pocket, carefully insert it into the luminometer,
ensuring that it is correctly orientated, and then push it fully down
until it clicks into position.

(1) Insert pocket in (2) Push fully down (3) Push RS232
the orientation until it clicks into cover back under lip
shown place

WARNING: Do not use excessive force when replacing the pocket.


If the pocket jams during insertion, remove it fully, check for
obstructions or damage, and then try again.

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Finally ensure that the black rubber RS232 cover is tucked in under
the lip and that the lid can be fully closed. (see section 5.6).
7. Troubleshooting
This section lists typical problems that might be encountered when
using the luminometer, and the possible causes and remedies.
Some problems can be rectified by the operator, and others may
require technical assistance:
Severity Action Required
✓ This indicates a cause which can be rectified by the operator.
This indicates a cause which may require technical attention.

Contact your local distributor for further assistance.

TIP: Most problems are likely to be transitory, and can be cleared by


pressing the button, or by turning the luminometer off and then
back on. In some cases you may need to remove the batteries for 30
seconds and then reinsert them. If any problem persists, please
contact your local distributor for technical assistance, giving full
details of the error code.
7.1 Luminometer Beeps
During normal use, the luminometer emits a variety of different
beeping sounds:
Beep Type Possible Causes
Short high- ✓ Luminometer turned on or off
pitched tone ✓ Sample measurement started
✓ Communications established with PC
✓ Results memory being erased
Long high- ✓ Luminometer calibration self-checks complete
pitched tone ✓ Sample measurement complete
✓ Results memory erase complete
Long low-pitched ✓ Invalid date entered
tone ✓ Program thresholds not set-up
✓ Invalid program threshold limits entered
✓ Attempting to select a non-failed (pass/caution) result for retesting
Two short high- ✓ Calibration self-checks required – remove testing device and close the lid
pitched tones
Three short ✓ Clock set-up required
high-pitched ✓ Batteries are low
tones ✓ Memory full warning
✓ Memory erase requested
✓ Luminometer error (see section 7.3)

7.2 Troubleshooting Tips


If the luminometer appears to be malfunctioning for any reason, carry
out a thorough check for any obvious damage to the case, lid, LCD
screen, battery contacts, etc., caused by dropping or excessive
physical mishandling.

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The following table lists typical symptoms and their possible causes.
Symptom Possible Causes
Luminometer will ✓ Batteries are low
not turn on when ✓ Batteries are the wrong type
the button is ✓ Batteries incorrectly inserted
pressed  Luminometer or keypad damaged or faulty
Luminometer will ✓ Luminometer is busy performing a reading or calibration self-check
not turn off when operation
the button is ✓ Luminometer lockup – remove the batteries for 30 seconds, then insert
pressed them again
 Luminometer or keypad damaged or faulty
Luminometer turns ✓ Batteries are low
off unexpectedly ✓ Batteries are loose within the battery compartment
✓ Luminometer dropped or subjected to shock or vibration
✓ Luminometer not used for 10 minutes and automatically enters standby
mode
 Luminometer damaged or faulty
Luminometer beeps ✓ Batteries are low
when turned on, but  Luminometer or display damaged or faulty
nothing is displayed
Clock reverts to ✓ Batteries have been replaced
12:00 01/01/2000 ✓ Batteries are low
✓ Batteries are loose within the battery compartment
✓ Luminometer dropped or subjected to shock or vibration
 Luminometer damaged or faulty
The display ✓ Luminometer is too hot or too cold
appears washed ✓ LCD contrast incorrectly adjusted (see section 3.9)
out or very dark ✓ Luminometer is being used in inappropriate lighting conditions
 Luminometer or display damaged or faulty
Display segments ✓ Display window is dirty
missing or garbage  Display window is scratched or dented
displayed  Display or luminometer damaged or faulty
Keypad button has ✓ Some buttons only work when selecting particular luminometer functions
no effect when ✓ Lid not fully closed
pressed  Keypad or luminometer damaged or faulty
Luminometer lid will ✓ Protective pocket incorrectly or not fully inserted
not close properly ✓ RS232 connector cover is interfering with the lid (see section 6.3)
or springs open ✓ Testing device incorrectly or not fully inserted
during use  Lid or luminometer casework damaged
Measurement result ✓ Incorrect use of testing device
is always zero RLU ✓ Luminometer not in upright position when measurement taken
or is much lower ✓ Testing device is out-of-date
expected ✓ Luminometer used in an unstable thermal environment – turn the
luminometer off and back on
✓ Protective pocket or testing device not fully inserted into luminometer
✓ Protective pocket dirty or severely scratched
 Protective pocket damaged
 Luminometer damaged or faulty
Measurement result ✓ Incorrect or inconsistent use of the testing device
is higher than ✓ Lid not fully closed
expected ✓ Luminometer used in an unstable thermal environment – turn the
luminometer off and back on
 Luminometer casework or lid damaged or faulty
RS232 interface ✓ Wrong interface cable being used
does not appear to ✓ Cable connector incorrectly inserted into luminometer
be working ✓ Cable connected to wrong port on PC
✓ Wrong PC software being used
✓ PC software incorrectly installed or wrong options selected
 Cable or connectors damaged or broken
 PC serial port or system software faulty
 Luminometer damaged or faulty

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7.3 Luminometer Error Codes
During normal operation, the luminometer performs
various self-checks on its internal components. If a
problem is detected, the display will show an error
number:

Error Code Possible Causes


E1 Not applicable on the luminometer
E2 ✓ The luminometer is being used outside of the
Temperature out specified operating temperature range (see
of range section 10)
✓ The luminometer has been stored in an
environment which is outside of its specified
operating temperature range
 Luminometer damaged or faulty
E3 ✓ Luminometer environment unstable or used in
Erratic an area of high electromagnetic noise
measurement ✓ Luminometer tilted while measurement being
performed
✓ Luminometer lid damaged and allowing light in
✓ Protective pocket dirty or severely scratched
 Luminometer damaged or faulty
E4 ✓ The user configurable settings are undefined -
User settings check and re-set the CLOCK format, User:,
undefined Plan: and Prog: data
E5 ✓ Program thresholds not defined, and have been
Program, Test reset to the default values (10 and 30)
Plan or User ID ✓ Test Plan data not defined
undefined ✓ User ID not defined
E6 ✓ Power the luminometer off and then back on
Calibration self- ✓ Luminometer operating environment unstable
checks failed ✓ Protective pocket dirty or severely scratched
✓ Lid not fully closed
 Lid seal damaged
 Protective pocket damaged
 Luminometer damaged or faulty
E7 ✓ Batteries are low or loose
Internal memory  Luminometer memory damaged or faulty
failure
E8 ✓ Batteries are flat or loose
Internal reader  Luminometer sample reader is damaged or
fault faulty
E9 ✓ Batteries are flat or loose
Internal error ✓ Luminometer dropped or subjected to shock or
vibration
 Luminometer damaged or faulty

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8. Unit Warranty and Returns
The Supplier warrants the luminometer, when purchased new, to be
free from defects in materials and workmanship, and will repair or
replace, at their discretion, any luminometer which, used under
proper conditions, exhibits such defects.
Under the terms of this warranty, the product must be returned in the
original packaging, transportation prepaid, with a copy of the Proof of
Purchase, to your local distributor. Contact your local distributor to
receive authorization to return the instrument, and enclose a detailed
description of the problem.
8.1 Warranty Duration
This warranty is provided to the original purchaser for one year from
the date of purchase. In no event will Hygiena be liable for indirect,
incidental or consequential damages; the original user’s remedies
being limited to repair or replacement of the unit at the
manufacturer’s option.
8.2 Particular Exclusion
Unauthorized modification of any part of the luminometer or the use
or attachment of any peripheral not supplied or specified by Hygiena
will void this Warranty.
WARNING: Use only the accessories and consumables supplied
by Hygiena. The use of any non Hygiena supplied accessories and
consumables will invalidate the warranty.
9. Glossary of Terms and Abbreviations
ATP Adenosine Triphosphate – energy carrier molecule
Device The testing sample collection and chemistry reaction device
EMC Electro-Magnetic Compatibility
fmol Femtomole (10-15 moles)
HACCP Hazard Analysis Critical Control Point
LCD Liquid Crystal Display
NiCD Nickel Cadmium rechargeable batteries
NiMH Nickel Metal Hydride rechargeable batteries
IBM compatible personal computer of Pentium 1 specification or higher, running
PC Windows 98 or later
Reading Measurement value in RLUs
Result Measurement pass ( ), caution ( ) or fail ( )
RLU Relative Light Units (unit of measurement)
Serial communications protocol for connecting the unit to a PC, used for
RS232 uploading test results data
USB Universal Serial Bus used to connect computer peripherals to a PC
Luminometer The SystemSURE Plus, EnSURE units

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10. Technical Specification
General
Unit dimensions (W x H x D) 72mm x 191mm x 32mm
Unit weight (including batteries) approx. 260g
Operating temperature range 5°C to 40°C
Relative humidity range 20% to 85% non-condensing
Storage temperature range -10°C to 40°C
Relative humidity 20% to 95% non-condensing
Range
Unit Details
Measurement range 0 to 9999 RLUs
Measurement resolution 1 RLU
Measurement time 15 seconds
Measurement noise ±5% or ±5 RLUs
User IDs 200 IDs of 16 characters
Programmable result thresholds 5001 programs
Programmable location names 5001 names of 20 characters
Test plans 100 plans of 251 programs
Results memory size 2000 tests
Serial interface EIA-232 compatible
Batteries
Battery Size (2 off) AA, LR6 or E91
Battery Types
Non-rechargeable nom. 1.5V Alkaline
Rechargeable nom. 1.2V NiMH or NiCD
(externally charged)
Battery Capacity (for 2600mAh)
Standby mode (at 20°C) min. 6 months
Continuous reading min. 2000 tests

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11. Cautions and Warnings
Operating Environment and Electrostatic Precautions
WARNING: Do not use the unit in any area which has been, or is
thought to have been, exposed to explosive or flammable gases or
vapours.
CAUTION: Avoid operating the unit in direct sunlight. Never leave the
unit in direct sunlight, even when turned off.
CAUTION: Do not expose or operate the unit in extremes of
temperature (see section 10), and minimise any exposure to
electrostatic charges.
Unit Handling and Use
CAUTION: Care should be taken not to drop the unit or subject it to
any form of rough physical handling, both during normal use and
during storage and transportation.
CAUTION: To avoid the risk of injury or choking, never use the unit
neck strap in situations where it could get caught in machinery.
CAUTION: To prevent dust and dirt ingress, always keep the unit lid
closed when not inserting or removing a testing device.
Batteries
WARNING: Use only non-rechargeable alkaline batteries, or
rechargeable NiMH/NiCD batteries, of types specified in section 10.
WARNING: Do not use batteries with individual cell voltages greater
than 1.65V, as this will cause permanent damage.
CAUTION: All batteries should be disposed of in accordance with your
local regulations.
Use and Insertion of Testing Devices
CAUTION: Refer to the testing device data sheet and kit insert for
details before using the testing device, and observe all federal, state
and local environmental regulations.
CAUTION: Do not force testing device into the unit. Do not attempt to
insert any object other than an approved testing device into the unit.
CAUTION: Ensure that the testing device is clean and dry before
inserting it into the unit.
Keypad Buttons
CAUTION: Do not use excessive force when pressing any of the
buttons on the unit's keypad.
RS232 or USB Connector
WARNING: Computer equipment connected to the RS232 connector
at the top of the unit must conform to BS EN 60950/IEC950
standards.
Unit Casework and Serviceability
WARNING: There are no Operator serviceable parts inside the unit.
Removal or opening of the unit's casework will void the warranty.

29 INS0228 July 2020


WEEE Directive Compliance
The luminometer should be disposed of in accordance with
the European Union WEEE Directive 2012/19/EU, on Waste
Electrical and Electronic Equipment.
WARNING: Do not dispose of this product into unsorted
municipal waste or a public landfill. Please contact your
local distributor for details of how to correctly dispose of
this product.

Regulatory Limitations of Use


The luminometer has been designed to meet the following general,
safety and EMC requirements:
General • Low Voltage Directive 2014/35/EU
• EMC Directive 2014/30/EU
• RoHS Directive 2015/863
Safety • IEC 61010-1 3rd edition
EMC • EN 61326-1:2013, IEC 61326-1:2012
• EN 55011:2009/A1:2010, FCC 15 SubPart B
• CISPR 11:2009/A1:2010, ICES-003 Issue 6
Immunity • EN 61326-1:2013, IEC 61326-1:2012
• EN 61000-4-2:2009, IEC 61000-4-2:2008
• EN 61000-4-3:2006: +A1:2008 + A2:2010,
IEC 61000-4-3:2006 + A1:2007 + A2:2010
• EN 61000-4-8:2010, IEC 61000-4-8:2009
The luminometer is manufactured under ISO 9001 controls.

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