NAWA TR26 User manual

NAWA wound pH meter TR26
Instructions for Use

Version 13 – 01/2019 1
Content
1 Introduction ...................................................................................................................... 2
2 Safety measures .............................................................................................................. 3
2.1 Warning signs and symbols .......................................................................................... 3
2.2 Product-specific safety instructions .............................................................................. 3
3 Setup and functions ......................................................................................................... 5
3.1 Overview ...................................................................................................................... 5
3.2 Bayonet lock ................................................................................................................ 5
3.3 Display window ............................................................................................................ 5
4 First commissioning ......................................................................................................... 6
4.1 Delivery scope .............................................................................................................. 6
4.2 Commissioning ............................................................................................................. 7
4.2.1 Preparation ........................................................................................................... 7
4.2.2 Charging ............................................................................................................... 7
4.2.3 Preparing the ISFET-sensor .................................................................................. 7
4.2.4 Setting the time ..................................................................................................... 8
4.3 Activating and deactivating the device .......................................................................... 8
4.4 Test measurements...................................................................................................... 9
5 Operation ....................................................................................................................... 10
5.1 Calibration .................................................................................................................. 10
5.2 Measuring pH value and temperature ........................................................................ 12
5.3 Measurement data ..................................................................................................... 13
5.3.1 Saving ................................................................................................................. 13
5.3.2 Readout / Recall .................................................................................................. 13
5.3.3 Deleting ............................................................................................................... 13
6 Maintenance .................................................................................................................. 14
6.1 Cleaning ..................................................................................................................... 14
6.2 Disinfection ................................................................................................................ 14
6.3 Storing........................................................................................................................ 15
6.4 Error indications ......................................................................................................... 15
6.5 Return and disposal ................................................................................................... 16
7 Technical data ................................................................................................................ 17
8 Accessories / Order form ............................................................................................... 18
9 Warranty disclaimer ....................................................................................................... 19
10 Labeling ......................................................................................................................... 19
11 Warranty ........................................................................................................................ 20

Version 13 – 01/2019 2
1 Introduction
We would like to thank you for purchasing a NAWA wound pH meter TR26.
NAWA wound pH meter TR26 is an electric mobile pH meter for measuring the pH
value and temperature in open, acute and chronic wounds.
The TR26 is a light and easy to handle pH meter and provides fast and reliable data
for all your measurements.
Please note that the device should only be used for the collection of clinical data
in the context of studies or application observations in accordance with §6
chapter 1 MPG.
Please read this leaflet carefully and follow the instructions.
Store it for later use and make it accessible to other users.

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2 Safety measures
2.1 Warning signs and symbols
Caution
Important information
Read Instructions for Use
2.2 Product-specific safety instructions
The pH meter TR26 complies with the current state of the art and is subject to certified
safety regulations. Nevertheless, hazards can result from improper use.
This device should only be used by trained wound care personnel to measure in open
acute and chronic wounds. Surgical-invasive wounds and wounds with a diameter of
less than 11 mm are excluded.
The housing of the device must not be opened by the user, as maintenance is only
allowed to be performed by technical support authorized by NAWA Technology Ltd. If
there are any problems, please contact NAWA Technology Ltd. directly.
The wound pH meter TR26 was designed to measure the pH value and
temperature in open acute and chronic wounds.
The manufacturer cannot be held responsible for damage caused by
improper use and use outside the intended purpose.
It is therefore essential to read and follow the information contained in
these instructions for use.
Wearing protective gloves is absolutely necessary!
NAWA wound pH meter TR26 is a sensitive electronic device. Handle it
carefully and do not subject it to mechanical impact and direct sunlight.
The product is designed so that there are no risks of fire or explosion in
the event of defects, if the device used properly.

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Please do not use sharp objects for cleaning.
Only use mikrozid® sensitive liquid from Schülke & Mayr for disinfection
(see chapter 8 Accessories).
Disinfect the device carefully before and after each use to prevent germ
spreading.
Be sure to comply with the exposure time of 5 minutes. Only then can a
germ-free use of the pH meter be guaranteed.

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3 Setup and functions
3.1 Overview
Fig. 1
1 Probe
2 Bayonet lock (see chapter 3.2)
3 Measuring device
3.2 Bayonet lock
Fig. 2a Fig. 2b
Probe and measuring device as well as measuring device and charging station are
connected via bayonet lock. To do this, insert both parts into the matching opening
(see red arrow) and turn until both parts are locked into place.
3.3 Display window
Fig. 3
1 Touch sensor
2 pH value display
3 Temperature display (in °C)
4 Battery level display
1
2
3
2
1
4
3

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5
7
6
8
2
3
4 First commissioning
4.1 Delivery scope
Check the completeness of the delivery (see attached checklist).
Before putting the device into operation, check it for visually detectable damage.
In this case, do not operate the device.
Fig. 4
Fig. 5
1 L of mikrozid® sensitive liquid disinfectant from Schülke & Mayr.
(Included in the starter kit; extra packaged)
Fig. 6
5 Buffer solutions
(4,01; 7,00; 10,00)
6 USB stick
3 Measuring device
with touch sensor
4 Probe with
ISFET-sensor and
protective cap
4
1 Test tubes (5x)
2 NAWAlution
1
8 Charging station
7 USB cable

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4.2 Commissioning
4.2.1 Preparation
Always use commercially available disposable gloves when using the pH meter
TR26!
Prepare the following equipment:
 sterile gauze
 3 non-tilting glasses for the buffer solutions
 Water (tap water in G/A/CH, still mineral water in all other countries, NO distilled
water)
 Test tubes for water
 Scissors
 PC/Laptop/Tablet PC with USB port
 Disinfectant mikrozid® sensitive liquid from Schülke & Mayr (possibly small
funnel)
 NAWAlution 50ml spray
4.2.2 Charging
Before using the meter (3) make sure it is sufficiently charged.
 Insert measuring device (3) into charging station (8) and turn until bayonet lock
interlocks.
 Connect the charging station (8) to a power supply via USB cable (7) (eg: USB
charger, laptop, PC, regular power outlet).
 The recommended charging time is 1 hour.
 Charging the device can also be done before preparation (see chapter 4.2.1).
4.2.3 Preparing the ISFET-sensor
The ISFET-sensor in the probe tip must be activated by humidification before first
use or in case of longer storage (from approx. 14 days).
 Place a test tube in the mount in the upper pocket insert.
Fig. 7
 Fill the test tube with about 3 cm of water (G/A/CH: tap water, all other countries:
still mineral water, no distilled water).

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 Place the probe (4) (without protective cap) in the test tube (1) for approx. 15
min.
 Then carefully dab the probe tip with sterile gauze.
4.2.4 Setting the time
Set the current date while preparing the ISFET-sensor in the probe tip (point 4.2.3).
The meter takes over the time zone of your PC (Windows and iOS)
 Connect the measuring device to the charging station (bayonet lock).
 Connect charging station (8) and USB cable via USB port to
PC/laptop/tablet PC.
 Open the folder of the storage medium.
 Double-click the "createsystemtime.exe" file (located on the meter's memory
and on the included USB stick).
 Safely remove the USB connection ("eject" the meter).
 Disconnect the meter (3) from the charging station (8) (open the bayonet lock).
4.3 Activating and deactivating the device
Activation:
The meter turns on automatically as soon as probe and measuring device are
connected (bayonet lock).
While measuring, all data is automatically stored on the meter and can be accessed
via PC/laptop/tablet PC.
Confirming actions:
During the calibration or measuring process, the display prompts you to confirm
individual steps: Tap the touch button with your thumb or forefinger, do not press.
Deactivation:
The display will blank out, if probe and measuring device are disconnected (bayonet
lock).
The data remains stored on the meter until manually cleared.

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4.4 Test measurements
Perform a test measurement for a first measurement or for a measurement after a
longer inactivity of the device.
Use all buffer solutions (4.01 / 7.00 / 10.00)
First, prepare the buffer solutions.
Place one buffer solution in each of the 3 jars, cut the bags open at the mark. DO
NOT decant the buffer solutions. Do not store once opened buffer solutions and do
not reuse them and do not dispose of in the household waste.
 Fill test tubes with water (Tap water in G/A/CH, still mineral water in all other
countries; NO distilled water).
 Remove the protective cap.
 Connect the probe (4) to the measuring device (3)
(bayonet lock, see fig. 2a and 2b).
 The meter displays "desinfected?"
 Confirm by touching the touch sensor (see Fig. 3).
 Immerse the probe tip in the buffer solution.
 The display shows "start?"
 Confirm with a tap on the touch button.
 Wait for the (long) beep that indicates the end of the measuring process.
 Check if the displayed value is correct.
 Now disconnect the measuring device (3) from the probe (4).
 Briefly insert the probe into the water-filled test tube (1) and then carefully dab
the probe tip with the sterile gauze.
Results comply (= match with the pH value of the buffer solutions):
Continue with chapter 5.2.2 Measurement
Results do not comply:
Continue with chapter 5.1 Calibration

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5 Operation
The pH meter will be shipped to you disinfected and calibrated.
Please check, with the help of a test measurement, whether the calibration is still
valid. If so, you can start measuring directly (chapter 5.2.2). If not, you need to
recalibrate the device (chapter 5.1).
5.1 Calibration
First, prepare the buffer solutions.
Place one buffer solution in each of the 3 glasses, cut the bags open at the mark.
DO NOT decant the buffer solutions.
Do not store once opened buffer solutions and do not reuse.
Remainders may not be disposed of in the household waste.
Fill a test tube with water (see chapter 4.2.1).
DO NOT disconnect the measuring device (3) from the probe (4) during calibration!
Always perform the calibration in the prescribed order (from 4.01 to 7.00 to 10.00)
for the readings to be correct.
 Connect the measuring device (3) to the charging station (8) (bayonet lock).
 Connect the charging station (8) via USB cable (7) to your PC / laptop / tablet
PC.
 Connect the USB stick (6) to your PC.
 Send the file "cal.txt" (on the USB stick (6)) to the memory of the measuring
device (3): press the right mouse button - "send to" - meter (3).
 Safely remove the USB connection ("eject" the meter (3)).
 Disconnect the measuring device (3) from the charging station (8).
 Remove the protective cap from the probe (4), if you have placed it on the probe,
connect the probe (4) and the measuring device (3) via the bayonet lock.
 The display shows „CAL pH=4 start?“.
 Dip the pH meter into the buffer solution (5) pH 4,01.
 Confirm by tapping the touch button.
 The display shows „CAL pH=4 started“.
 Wait for the beep at the end of the first calibration step.

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 Extract the pH meter from the buffer solution (5).
 Briefly insert the probe (4) into the water-filled test tube (1)
and then carefully dab the probe tip with the sterile gauze.
 The display now shows „CAL pH=7 start?“.
 Dip the pH meter into the buffer solution (5) pH 7,00.
 Confirm by tapping the touch button.
 The display shows „CAL pH=7 started“.
 Wait for the beep at the end of the second calibration step.
 Extract the pH meter from the buffer solution (5).
 Briefly insert the probe (4) into the water-filled test tube (1)
and then carefully dab the probe tip with the sterile gauze.
 „CAL pH=10 start?“ is now shown on the display.
 Dip the pH meter into the buffer solution pH 10,00.
 Confirm by tapping the touch button.
 The display shows „CAL pH=10 started“.
 Wait for the beep and the display of „CAL complete“ at the
end of the calibration.
 Extract the pH meter from the buffer solution (5).
 Briefly insert the probe (4) into the water-filled test tube (1)
and then carefully dab the probe tip with the sterile gauze.

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5.2 Measuring pH value and temperature
a. Place an unused test tube into the holder.
Caution: Use a new test tube for each wound.
b. Fill the test tube with max. 6 ml of mikrozid® sensitive.
c. Remove the protective cap from the probe tip.
d. Dip the probe into the disinfectant for 5 minutes (see chapter 6.2 Disinfection).
e. Extract the probe from the disinfectant.
f. Spray the probe with NAWAlution and carefully dab the probe with a sterile
gauze.
g. Connect the probe (4) with the measuring device (3) (bayonet lock, see fig.
2a+b).
h. The display shows „desinfected?“.
i. Confirm by tapping the touch sensor (see fig. 3).
j. The display shows „start?“.
k. Confirm by tapping the touch sensor.
l. Place the probe carefully and without pressure onto or into the wound.
m. Hold the device still, so that the values for the measurement can stabilize.
n. Wait for the beep (Duration max. 30sec).
o. The display shows the measured data (pH value and temperature).
The data is stored and can be accessed via PC/laptop/tabled PC even after the
display has turned blank (step q).
p. Enter these values in your documents.
q. Now disconnect the measuring device (3) from the probe (4); the display will
turn blank.
r. Place the probe in the disinfectant for 5 minutes (see chapter 6.2 Disinfection)
s. Extract the probe from the disinfectant.
t. Spray the probe with NAWAlution and gently dab the probe tip with a sterile
gauze.
Repeat steps f. to s. for further measurements

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5.3 Measurement data
5.3.1 Saving
All measured data are automatically stored on the meter.
The data of each measurement is shown on the display as long as probe and measuring
device are connected.
You can retrieve the individual measurement data from your PC.
The measurements remain stored on the meter until you manually clear them (see
chapter 5.3.3).
5.3.2 Readout / Recall
 Connect the measuring device (9) and the charging station (7).
 Connect the charging station via USB cable to your PC / laptop / tablet PC.
 The pH meter is displayed as external memory on your PC.
 All measurements are saved as Excel files and labeled with the date and time
of each measurement (e.g., "2018-10-18_17-07-18").
 These files contain the pH value, temperature, date, time and a security key
(against manipulations).
 The data on the pH meter's memory can only be deleted at the PC.
5.3.3 Deleting
The measured data are stored on the meter and can be viewed on the PC.
The stored data on the pH meter's memory can only be deleted at the PC.

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6 Maintenance
6.1 Cleaning
Simple cleaning is not sufficient for the probe and measuring device of the pH meter
TR26. Please disinfect the device before and after each use as described in chapter
6.2.
Always spray a pump of NAWAlution into the protective cap before placing it on the
probe tip.
The charging station of the pH meter is NOT waterproof. Avoid direct contact
with water or any other liquids.
6.2 Disinfection
Only use mikrozid® sensitive liquid from Schülke & Mayr for disinfection (see chapter
8 Accessories).
Disinfect the device carefully before and after each use to prevent germ spreading.
Be sure to comply with the exposure time of 5 minutes. Only then can a germ-free use
of the pH meter be guaranteed.
Application:
 Fill a test tube with disinfectant (6 ml max.).
 Insert the probe without the protective cap for 5 minutes.
 Apply the disinfectant to a sterile gauze and clean the meter and, if necessary,
the charging station.
 Gently dab the probe tip with a sterile gauze.
 Then spray the probe tip with NAWAlution.
You can now use the probe for another measurement (see chapter 5.2.2).
Before storing, always spray a pump of NAWAlution into the protective cap so
that it can be easily removed before the pH meter's next use!

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6.3 Storing
After use, always store the pH meter disinfected, cleaned and with the protective cap
attached (see chapter 6.2 Disinfection) in the supplied NAWA bag.
Before storing, always spray a pump of NAWAlution into the protective cap so
that it can be easily removed before the pH meter's next use!
Storage at temperatures below 10°C and above 40°C reduces the service life of the pH
meter (see Chapter 7 Technical data).
6.4 Error indications
No display
acticvity
 Check if the meter is sufficiently charged.
 Charge the meter for about 1 hour.
 If this error persists, contact the NAWA Technology
Ltd. customer service.
Individual steps
cannot be
confirmed with
the touch button
 The touch sensor responds to tapping, not pressing.
 Lightly tap the button.
 If this error persists, contact the NAWA Technology
Ltd. customer service.
pH values and /
or temperature
are out of the
specified
measuring range
 Make sure to moisten the sensor in the probe tip before
each use or after longer inactivity (from 14 days).
 Recalibrate the device.
 If this error persists, contact the NAWA Technology
Ltd. customer service.
The device skips
a step during
calibration
 Finish the calibration as specified.
 Recalibrate the device.
 If this error persists, contact the NAWA Technology
Ltd. customer service.
The display
shows "PROBE
LOST"
 Check the connection between the probe and the
measuring device.
 Disconnect the probe from the measuring device.
 Reconnect the probe and the measuring device via
bayonet lock.
 If this error persists, contact the NAWA Technology
Ltd. customer service.

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The protective
cap can not be
removed from the
probe
 Place the probe with the cap on in water for about 1
minute.
 Now remove the protective cap.
 Follow the instructions for maintenance shown in
chapter 6.
 If this error persists, contact the NAWA Technology
Ltd. customer service.
6.5 Return and disposal
Always use the included bag when returning the device.
The device must not be disposed of in the household waste.

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7 Technical data
Measurement
accuracy
:
pH value: ±0,2
T
emperatur
e
: ±0,5°C
Measuring range
:
pH value: pH 3-12
Temperatur
e
: 15°
-
40°C
Dimensions: Length (meter): 100,0 mm
Diameter (meter): 28,4 mm
Length (probe): 135,0 mm
Diamater (probe shaft): 10,4 mm
Overall length
:
235,0 mm
Acceptable storage
temperature
:
10°C - 40°C
Range of relative
humidity:
20% - 95%, no condensation
EMV Only the supplied charging station and the supplied
USB cable may be used to connect the NAWA wound
pH meter TR26 to
a PC or similar devices
.
The meter complies with the applicable sections of the
EU Medical Device Directive 93/42/EC, the Medical
Devices Act and European Standard EN60601-1 and
is subject to special precautions regarding
electromagnetic compatibility.

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8 Accessories / Order form
Additional meter and accessories included in the starter kit can be ordered from NAWA
Technology Ltd.
Please use the form below.
You can send your order by email to [e-mail]
or by fax to [phone].
Company:
Contact:
Address:
Telephone number:
Email:
Item
Article number
Quantity
Price
pH meter TR 26 - Starter set
complete with probe, measuring device,
charging station, USB cable, USB stick,
NAWA bag with inserts, buffer solutions (1x
each for 4.01 / 7.00 / 10.00), NAWAlution
50ml, 5 test tubes, 1L disinfecting solution
mikrozid ® sensitive liquid and IFU.
11001490001
Probe
11001490002
M
eter
11001490003
Charging station
11001490004
USB
cable
11001490005
USB
stick
11001490006
NAWA
bag
with
inserts
11001490007
Buffer solution
4
.
01,
set of 3
11001490008
Buffer solution
7
.
00,
set of 3
11001490009
Buffer solution
10
.
00,
set of 3
11001490010
NAWAlution 50 ml
11001490011
mikrozid ® sensitive liquid; 1 L
11001490012
Test tubes
,
set of 5
11001490013
We hereby order the above-mentioned items with costs.
Date / Company stamp / Signature

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9 Warranty disclaimer
The manufacturer is not liable for improper use, neglected instructions and
carelessly ignored specifications.
This device should only be used by trained wound care personnel to measure
the pH value and temperature in open acute and chronic wounds. Surgical-
invasive wounds and wounds with a diameter of less than 11 mm are excluded.
No measurements on children weighing less than 2.5 kg.
10 Labeling
Non sterile
Serial number / : see type plate on the device
Temperature limitation
Do not dispose of in household waste
Humidity limitation
Protect from moisture