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User Manual
PulsePen
PulsePen device is manufactured by DiaTecne s.r.l.
⚠ This manual is an integral part of the product and must be kept together with it.
Composition
The PulsePen device, code WPP001-ET / WPP001-ETT includes the following parts:
•
Tonometric unit, code wTn1, for the capture of a pressure signal with the non-invasive “applanation
tonometry” method. The number of such units included in the package is one for the WPP001-ET device
and two for the WPP001-ETT device.
•
ECG unit, code wEc1, for one electrocardiographic lead capture.
•
Signal receiver unit, code wRs1, to be inserted in one USB port of the computer, for synchronization and
collection of signals coming from wTn1 and wEc1.
•
2 ECG cables with crocodile terminals , code CV010.
Generic accessories:
•
USB memory with Software, Tutorial, this manual in pdf format.
•
2 or 3 Alkaline batteries 1.5 V - AAA - IEC LR03, depending on the model.
•
Guarantee Certificate.
•
Carrying Bag
WPP001-ET: WPP001-ETT:
Note: the PulsePen works with a computer, supplied by the user, in order to display and save signals.
The computer connection is galvanically isolated due to the radio link with the wRs1 unit. Furthermore,
during patient examination, it is necessary to input the systolic and diastolic pressure values measured with
a validated sphygmomanometer supplied by the user.!
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Tonometric unit: wTn1
1. On / Off button: keep pressed for about 1 sec.
2. Cap for battery replacement: pull away from the tonometer’s body. Push the old battery toward you from
the hole of the opposite side of the opening. Gently insert the new fresh battery following the polarity
specified on the label. Put the cap on and push it until snap occurs.
3. Active part of the tonometric sensor.
ECG unit: wEc1
1. On / Off button: keep pressed for about 1 sec.
2. Cap for battery replacement: pull away from the unit’s body. Extract the old battery. Gently insert the
new fresh battery following the polarity specified on the label. Put the cap on and push it until snap
occurs.
3. Patient cable sockets.
Signal Receiver unit: wRs1
1. Led indicates the operating mode. This Led blinks green when the PulsePen software is not running or if
the USB driver is not correctly installed. This Led is fixed green during normal operations while it is red
during reprogramming / update.!
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Intended Use
In this manual, when talking about device or equipment, the reference is to all its parts, unless otherwise
noted. Each unit alone does not produce useful results.
This medical device is intended to determinate the arterial stiffness and to record the arterial
pressure wave, by means of the “applanation tonometry”, for diagnostic purposes. It must be used by
qualified medical / paramedical personnel, familiar with the “applanation tonometry” method, in
medical environment or research centers.
The primary functions are capture, display and storage of the arterial tonometric
signal for later calculation of the related parameters including Pulse Wave Velocity PWV, that defines the arterial stiffness. This instrument is based on the applanation
tonometry principle. The user places the sensor on the skin, where the artery pulse is
found, with a moderate pressure that slightly compresses the artery (applanation
tonometry): in such way, a balance of the circumferential forces inside the vessel is
obtained and the sensor records the pressure inside the compressed artery.
Intermediate layers between sensor and vessel, with their thickness and rigidity, that
vary for each individual, influence the pressure measured by the sensor in a not, a
priori, quantifiable manner. For this reason it is necessary to calibrate tonometric
signals using the systolic and diastolic pressures obtained from an external
sphygmomanometer (supplied by the operator). The calibration process is based on
the assumption that diastolic and mean pressure substantially don’t change along the
arterial tree.
The pulse wave velocity is defined as the
propagation velocity of the pressure wave
(not of the blood) from the center to the
periphery and is therefore obtained by
dividing the distance between two examined
points (for example Carotid and Femoral) by
the related sphygmic wave transit time
(DeltaT).
This propagation time can be assessed in two different ways (I or II):
I. Using the wEc1 unit together with the wTn1 unit, first for Carotid (R-cW) and then for the peripheral
artery (e.g. the Femoral Artery in figure, R-fW ) , to measure the delay time between the R peak of the
ECG wave and the “foot” of the tonometric waves, time A and B, and then the difference between them,
DeltaT.
II. Using two wTn1 units to contemporarily capture two tonometric signals, one of the Carotid and the
other of the selected peripheral Artery, to obtain the time interval DeltaT between the two waves’ “feet”.
⚠ The ECG lead captured must only be used for PWV estimation and must never be used for any kind
of diagnosis on the patient! !
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Technical Specifications
Classification
Class IIa medical device according to the Directive 93/42/EEC
Computer Connection
WPP001-ET and WPP001-ETT devices connect to computer by inserting
wRS1 unit into one USB 1.0 / 2.0 - type A port:
Software Installation
The PulsePen system includes two softwares (x.x.x means the version):
•
WPulsePen (WPP001-ETT- x.x.x): full-featured software for capture, display, storage and analysis of
signals and calculation of significant parameters. It includes patient database management and works on
signals up to 10 ECG/ tonometric complexes. The patient report generated by this software must always
be verified by medical staff who is familiar with tonometry. DiaTecne s.r.l. is not responsible for the final
diagnosis.
•
WPulsePen-LP (WPP001 LP-ETT- x.x.x): software for capture, display and storage of long term signals.
It does not analyze signals or manage patient database.
wTn1:
On / Off button
Resolution: 0.004 mmHg
Dynamic range: ≥ 220 mmHg
Capture : 16 bit @ 1000 S/sec
Data Rx / Tx: radio link, ISM 2.4 GHz
Acoustic signal: On/Off switching
Power supply: Alkaline AAA - 1.5V IEC LR03 battery
Max applicable sensor force: 4.5 Kg
Vibrations: ≤ 20 g @ 10 Hz - 2 KHz sinusoidal
Shock: ≤ 150 g
Weight: 25g without battery
Dimensions [mm]: 114 (L) x 25 (W) x 20 (H)
wEc1:
On / Off button
Resolution: 0.15 µV
Dynamic range: ≥ ± 5 mV
Capture : 16 bit @ 1000 S/sec
Data Rx / Tx: radio link, ISM 2.4 GHz
Acoustic signal: On/Off switching
Power supply: Alkaline AAA - 1.5V IEC LR03 battery
Vibrations: ≤ 20 g @ 10 Hz - 2 KHz sinusoidal
Weight: 36g without battery
Dimensions [mm]: 49 (L) x 75 (W) x 21 (H)
wRs1:
P.C. Connection : USB 1.0 / 2.0 - type A
Power supply: powered by P.C. connector
Led: operating mode signaling
Data Rx / Tx: radio link, ISM 2.4 GHz
Weight: 12g
Dimensions [mm]: 67 (L) x 25 (W) x 11 (H)
CV010:
Universal terminals for tab, clip, press-stud electrodes.
Connectors DIN 42802 compliant
General:
Approximate autonomy (wEc1/wTn1): 50h
Operating ambient temperature: +5 $ C to +40 $ C
Transport and storage ambient temperature: -25 $ C to +70 $ C
Relative humidity: 30 - 80% non condensing
Atmospheric pressure: 860 - 1060 hPa
Computer:
Processor clock frequency ≥ 2GHz
Ram memory ≥ 2 GB
Free Hard Disk space ≥ 200 MB
Graphical resolution ≥ 1280 x 800, 256 colors
Operating system: Windows® XP SP2/3, Vista, 7, 8, 10 32/64 bit
Free USB ports: 1
IEC 60950-1 compliant
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In order to install the Software contained in the included USB memory, proceed as described below
avoiding insertion of the wRS1 unit in the USB port before completion of operations.
1. In the “WPulsePen x_x_x Install” folder, launch Setup.exe to install the WPulsePen software and the
wRs1 receiver USB driver. A desktop icon will be automatically created.
2. Once the installation is finished, insert the wRs1 unit in the USB port and wait for the correct device
identification. In case of problems, manually reinstall the USB drivers from folder “wRs Usb Driver”.
The font “Arial” is required for a correct use. Repeat the step 1 of the procedure if you wish to install also
the WPulsePen_LP software, selecting the “WPulsePen_LP x_x_x Install” folder.
Use of the device
Insert the wRS1 receiver in a USB port and wait for device recognition.
Extract the cap from the wEc1 and wTn1 units, insert batteries into the battery compartment strictly
following the indicated polarity (see pg 2) and close the cap.
⚠ Use only 1.5V IEC LR03 – AAA Alkaline batteries.
Note: dead batteries must be discarded in the special containers, since they are high-pollution wastes!
This device requires fresh disposable ECG electrodes Ag/AgCl
(incorporated with gel), that can be used for crocodile clips. Place
them as indicated in the figure:
Red: subclavian right region
Black: subcostal left region
The suggested position can be modified at the operator’s
discretion when ECG signals are too low, inverted or altered, for
example in case of pathologies. Direct electrodes contact with
synthetic dresses must be avoided because it may cause
superimposed noises; in this case it helps to put one sheet of
paper in-between.
Connect the crocodiles of the patient cable to the corresponding
electrodes according to their types (type A or type B, see figure
on the right) and plug the cable from the other side into the
corresponding wEc1 sockets.
Run the Software WPulsePen / WPulsePen_LP and switch on the wEc1 / wTn1 units by pressing the on/off
key until the beep(s) sound (about 1 sec). wEc1 makes a single “beep”, so does wTn1 when programmed as
Sensor1 (red trace), while wTn1 programmed as Sensor2 (blue trace) makes two “beeps”.
1. New examination.
2. Patient Archive access.
3. Setup and device programming.
4. Online Help.
5. Data exchange between computer and wRs1 (green when in normal function).
6. wRs1 USB unit connection (green when correctly recognized)
7. Graphical battery gauge for wEc1 and wTn1.
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8. Battery gauge for wEc1 and wTn1: change the battery when less than 10%.
9. Icon representing the ECG (QRS) or Tonometric (pressure wave) signals depending on active sensor.
10. Data coming from wRs1 to be processed: a short bar means better condition compared to a long bar
(depends on computer speed, other running programs, …).
11. The positive battery terminal becomes yellow during standby, i.e. when “Freeze” is active or during
situations different from run-time signals capture and display.
12. Sensor1 corresponds to the red signal (Ecg or Tonometer) while Sensor2 corresponds to the blue signal
(only Tonometer).
Functions described below are related to the WPulsePen Sw, of which the WPulsePen_LP Sw is a simplified
version.
Select the “New examination” icon and insert Patient information including name, surname, birth date,
gender: at this point the keys corresponding to the Arteries will be enabled. Choosing one of them, a new
window will be opened. Place the wTn1 probe/s on the region of interest: captured signals will be displayed
on the computer screen. An automatic freeze function stops the signal capture in case of no activity on
Sensor2 (blue trace).
In order to obtain good quality tonometric signals, the patient must be lying down on the bed. The operator
must keep his/her elbow firmly lying on a stable surface and hold the wTn1 probe as indicated in the figure
below with his/her fingers touching the patient’s skin, reducing in such way tremors. The probe must be
kept perpendicular to the skin and not tilted.
Once a good quality signal has been captured, when the traffic light on the topcentral screen shows green (more info from software Help), the operator can stop the
capture lifting out the Sensor2. The last 10 cardiac complexes are saved and
automatically analyzed by pressing the icon with the diskette symbol or the Enter
key. At this point, a new window will be displayed in order to insert systolic and
diastolic pressures measured immediately before or afterward by an external
sphygmomanometer. In case of peripheral artery, the operator should use, in addition,
a measuring tape to obtain three distances, in millimeters, between: CarotidPeripheral Artery, Carotid-Suprasternal Notch and Suprasternal Notch-Peripheral
Artery. In this way during the PWV assessment it’s possible to apply both methods
for the distance evaluation suggested by the international guidelines, i.e. the “direct”
method (direct distance multiplied by 0.8) and the “subtractive” one.
WPulsePen software manages the patient DataBase “WPPArch.dbd” located in the “WPulsePen_Data”
folder. Selecting the “Patient Archive” icon, all patients are shown with the related examinations and it’s
possible to choose which one to display on the screen.
WPulsePen_LP software saves single examinations in text format files (*.txt) in the subfolder “ASCII” of
the “WPulsePen_Data” folder.
The “Setup” icon allows to select language, date format, device programming, …, while the “Help” icon
opens a window with the software instructions (pls refer to this online Help for updated operating
instructions).
Activation of wEc1 and wTn1 units is shown on the computer screen (points 7, 8, 9, 11) of the software
menu image.
In order to switch off the Sensors wEc1 and wTn1, keep pressed the on/off key until the acoustic signal
(about 1 sec). The wEc1 and wTn1 units automatically switch off when closing the program or when there
is no connection with the wRs1 unit for more than 30 sec: e.g. when the software WPulsePen /
WPulsePen_LP is not executing or distance between them is too long.
The wEc1 and wTn1 units don’t transmit radio-frequency until a connection with the wRs1 unit was
established.
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The correct use of wEc1 and wTn1 units is based on the assumption that one of them must be set as
Sensor1 and the other as Sensor2: wEc1 is always set as Sensor1 and cannot be modified while wTn1 can
be set in the two different ways: pls refer to the software online Help for the operating instructions.
Allowed Combinations:
wEc1 - Sensor1 (1 beep at switch on) + wTn1 set as Sensor 2 (2 beeps at switch on). These are the factory
settings for the WPP001-ET system and for the wTn1 unit with black ring of the WPP001-ETT system:
[ ✔ ] +
wTn1 set as Sensor 1 (1 beep at switch on) + wTn1 set as Sensor 2 (2 beeps at switch on). These are the
factory settings for the wTn1 units respectively with red and black ring of the WPP001-ETT system:
[ ✔ ] +
Wrong Combinations:
wEc1 - Sensor 1 (1 beep at switch on) + wTn1 set as Sensor 1 (1 beep at switch on):
[ ✘] +
Both the wTn1 modules set as Sensor 1 (1 beep at switch on) or set as Sensor 2 (2 beeps at switch on):
[ ✘ ] +
[ ✘] +
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Maintenance and Cleaning
No particular periodic maintenance or calibration operations are required on the instrument.
⚠ In the case of prolonged non-use, remove batteries.
⚠ Before use, the metallic disc of the wTn1 probe, the patient cable CV010 and the probe’s case must be
cleaned, using a clean, dry cloth or dampened with a small quantity of alcohol.
⚠ Be very careful to keep the alcohol or other liquids from penetrating into the wTn1 probe or into the
other units because this could cause serious problems, irreparably damaging internal parts.
⚠ The CV010 Ecg cables are thin and flexible in order to be easily handled. One must avoid pulling or
bending them at sharp angle so as not to damage them.
Warnings and Precautions for Use
⚠ It is very important to read the following items before the use of the device. Improper use may cause
very severe consequences.
•
This equipment is intended to be used only by medical/paramedical personnel in medical environment.
•
Do not use the equipment in operating room, or in any case where there are inflammable gases/
substances.
•
Do not use the equipment for invasive or intra-cardiac applications or at direct contact with internal body
parts.
•
Data elaboration must be performed by the doctor through dedicated software.
•
Do not sterilize neither in autoclave nor with liquid substances.
•
Avoid mechanical shocks to the pressure plunger of the wTn1 probe, like collisions or falls.
•
Regularly clean the disc of the wTn1 probe, the terminals of the patient cable CV010 and the case after
each use, as indicated in the “Maintenance and Cleaning”.
•
Keep the units wTn1 and wEc1, with its patient cable, at a distance of no less than 1.5 meters from the
computer and the same computer at no less than 1.5 meters from the patient.
•
Avoid touching simultaneously any part of the computer, including the wRs1 unit, and one or both of the
wEc1, including the patient cable, and the wTn1 units.
•
Do not immerse any part of the device into water or other substances, or expose it to sprays. Absolutely
never use Gel on the pressure sensor of wTn1.
•
Do not open the device for any kind of maintenance work; in the case of malfunction of the device, contact
DiaTecne s.r.l.
•
In the case of any abrasion, sheath damage, or any kind of defects appears in the patient cable CV010,
immediately suspend use of the device and contact Diatecne s.r.l. for repair/replacement.
•
Do not use the device if breakage occurs to any part, do not try to repair it but contact Diatecne s.r.l. for
repair/replacement.
•
Do not make changes of any kind to the device and never use accessories other than those provided.
•
Keep the tonometric probe wTn1 and patient cable CV010 terminals away from electrical outlets/sockets
and surfaces where there may be potentially dangerous voltages.
•
Use a battery-powered (portable) computer or, alternatively, an AC-powered computer, compliant with the
current medical regulations.
•
Use the device at a safe distance from sources of electromagnetic disturbance such as cordless telephones
operating at radio frequency/cellular phones, Bluetooth and WiFi devices or other equipments emitting
high frequency electromagnetic waves.
•
During examination, keep the wEc1 unit at a distance of at least 20 cm away from both the patient and
operator, limit the duration of contact of the wTn1 unit with both patient and operator for the time
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required for the examination: this is to reduce the exposure time to the electromagnetic radiations due to
radio signal transmission, although the radio-frequency power is very limited.
•
Use only 1.5V batteries of the indicated type. Insert them as stated and check their condition before each
use (dead or damaged batteries may cause leakage of acid).
•
Do not switch on or use the device if the covers of the battery compartment are not correctly closed.
•
Insert the patient cable CV010 connectors only into the corresponding sockets of the wEc1 unit. Do not
connect those plugs in any other way.
•
The equipment must never be used together with a defibrillator, since it has not been designed for such
use.
•
During Carotid pressure signal recording, the compression of the Carotid bulbs may accidentally produce
reduction of heart rate. This kind of phenomenon could be more common in old aged patients with
accentuate vagal sensitivity. It is highly recommended to stop the examination upon appearance of
bradycardia. We furthermore remind that simultaneous compression of both Carotid bulbs is absolutely
forbidden, considering that this can cause syncope by arterial hypotension and severe bradyarrhythmias.
•
Install antivirus software on the computer used for the PusePen system.
•
Make backup copies of the patient archive on a regular basis, as described in the software on line Help.
•
Reduce the probability of radio interference following prescriptions of the next section.
•
Use the equipment only for the purposes stated in this manual.
•
DiaTecne s.r.l. cannot be held responsible for any damages caused to persons, animals, or things if the
user does not scrupulously follow the indications given in this manual.
Reciprocal Interferences with other Equipments
The PulsePen device was designed to be immune to electrical, electromagnetic, electrostatic and
magnetic disturbances that are present in normal environment; likewise, the PulsePen produces a small
amount of disturbances for other equipments. It cannot however be excluded that, in particular situations,
some functional anomalies could appear also in the form of signal alteration; in this case it is necessary to
remove all potential sources of disturbance when possible, or to move to a more appropriate location.
Considering that the “Intended Use” of the device requires a qualified medical operator, he/she may easily
recognize any anomalous functional situation, such as the presence of “noise” superimposed to the signal or
alteration of the morphology, and follow the indications suggested above.
Typical noise sources are the “hotspot”/WiFi devices, Bluetooth / Zigbee devices and any kind of
transmitter in the 2,4 GHz frequency band.
⚠ Ensure that the WiFi / Bluetooth functions of the computer and cellular phones are switched off
during the use of the PulsePen. When available activate the ‘flight/airplane mode’ on these devices.
•
Medical devices require special cautions for electromagnetic disturbances (EMC) and must be installed/
used according to instructions in the following tables.
•
Mobile devices for radio frequency communications may disturb electromedical devices.
•
For the correct use of the PulsePen, the wEc1 and wTn1 units must be in a 3 meters radius from the
wRs1 unit. Higher distance could influence the correct operation.
•
The use of cables and accessories different from those in the original package could adversely influence
the performances of the device.
•
Respect distances from other devices according to the following Tab. 4.
•
The PulsePen device transmits radio frequency in the ISM 2.4 GHz band with MSK modulation,
ERP = 2 dBm (P ≈ 1.6 mW).
•
The PulsePen system meets the requirements of the following tables.
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Tab. 1: Electromagnetic Emissions
Tab. 2: Electromagnetic Immunity
The PulsePen is suitable for use in the specified electromagnetic environment. The user of the PulsePen should
assure that it is used in an electromagnetic environment as described below.
Emissions tests
Compliance
Electromagnetic Environment
RF Emissions
CISPR 11
Group 1
The PulsePen uses RF energy only for its internal function.
Therefore, the RF emission is very low and not likely to cause any
interference in nearby electronic equipment.
RF Emissions
CISPR 11
Class B
The PulsePen is suitable for use in all establishments,
including domestic establishments and those directly connected to
the public low-voltage power supply network that supplies
buildings used for domestic purposes.
Harmonic Emissions
IEC 61000-3-2
Not Applicable
Voltage fluctuations /
Flicker Emissions
IEC 61000-3-3
Not Applicable
The PulsePen is suitable for use in the specified electromagnetic environment. The user of the PulsePen should
assure that it is used in an electromagnetic environment as described below.
Immunity
Te st
IEC 60601-1-2
Test level
Compliance
level
Electromagnetic Environment
Electrostatic
Discharge (ESD)
IEC 61000-4-2
±8 KV contact
±15 KV air
IEC 60601-1-2
Test level
Floors should be wood, concrete or ceramic tile.
If floors are covered with synthetic material, the
relative humidity should be at least 30%.
Electrical Fast
Transient / Burst
IEC 61000-4-4
±2 KV
Not Applicable
Mains power quality should be that of a typical
commercial or hospital environment.
Surge
IEC 61000-4-5
±1 KV differential
mode
±2 KV common mode
Not Applicable
Mains power quality should be that of a typical
commercial or hospital environment.
Voltage dips, short
Interruptions
and Voltage
variations on power
supply input lines
IEC 61000-4-11
0% UT , 0.5 cycle
@ 0°, 45°, 90°, 135°,
180°, 225°, 270°, 315°
0% UT , 1 cycle /
70% UT , 25/30
cycles , @ 0°
0% UT , 250/300
cycles
Not Applicable
Mains power quality should be that of a typical
commercial or hospital environment. If the user
of the PulsePen requires continued operation
during power mains interruptions, it is
recommended that the computer used with the
PulsePen be powered from an uninterruptible
power supply or a battery.
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Tab. 3: Electromagnetic Immunity
Power frequency
(50/60 Hz)
Magnetic Field
IEC 61000-4-8
30 A/m
IEC 60601-1-2
Test level
Power frequency magnetic fields should be at
levels characteristic of a typical location in a
typical commercial or hospital environment.
The PulsePen is suitable for use in the specified electromagnetic environment. The user of the PulsePen should
assure that it is used in an electromagnetic environment as described below.
Immunity
Te st
IEC 60601-1-2
Test level
Compliance
level
Electromagnetic Environment
Radiated RF
IEC 61000-4-3
10V/m
80 MHz - 2.7 GHz
10V/m
Levels characteristic of a typical location in a
typical commercial or hospital environment.
Conducted RF
I.C. 61000-4-6
3V
150 KHz - 80 MHz
6V ISM bands and
amateur radio
150 KHz - 80 MHz
Not Applicable
Levels characteristic of a typical location in a
typical commercial or hospital environment.
Interference may occur in the vicinity of equipment marked with the following symbol: &
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Tab. 4: Immunity to proximity fields from RF wireless communication equipments
The PulsePen is intended to be used in an electromagnetic environment in which radiated RF disturbances are
controlled. The user of the PulsePen can help prevent electromagnetic interference by maintaining a minimum
distance between portable / mobile RF communication equipments (transmitters) and the PulsePen as
recommended below, according to the maximum output power of the communications equipment.
Test Frequency
(MHz)
Band
(MHz)
Max Power
(W)
Distance
(m)
Immunity Test Level
(V/m)
385
380 - 390
1.8
0.3
27
450
430 - 470
2
0.3
28
710, 745, 780
704 - 787
0.2
0.3
9
810, 870, 930
800 - 960
2
0.3
28
1720, 1845, 1970
1700 - 1990
2
0.3
28
2450
2400 - 2570
2
0.3
28
5240, 5500, 5785
5100 - 5800
0.2
0.3
9
Minimum separation distances for higher immunity test levels shall be calculated as follows:
E= (6/d ) √P
Where P is the maximum power (W), d is the minimum separation distance (m), E is the immunity test level (V/m).
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Problems during use and solutions
The wEc1 / wTn1 unit does not turn On ( No acoustic signal):
•
Check if the battery is of the required type, if it is inserted in the right way and if it’s not dead.
•
Keep pressed the On/Off button till the acoustic signal (about 1 sec).
•
Remove and reinsert the battery.
No signals arrive to the computer:
•
Verify that the software icons related to the wRs1 unit are both green: if not the case, close and restart the
software. If the icon related to USB device recognition does not become green, close the software, remove
and reinsert the signal receiver wRs1 and restart the software. If the problem remains, it’s suggested to
reinstall USB drivers.
•
If both the icons related to the wRs1 unit are green, check if the wEc1 and wTn1 units are turned on and
that related software icons are active.
•
Ensure that computer protection software, such as Antivirus, Firewall, etc., does not prevent access to
external USB devices.
•
Make sure that the system is not in “Freeze” mode due to absence of tonometric signal on the wTn1
probe. Gently touch the pressure sensor with fingers.
•
In the “Setup” panel check if the radio channel of wRs1, wEc1, wTn1 units is the same. Pls refer to the
software on line Help for more details.
If the problems remain after the above attempts, or if you have doubts regarding the function of the
equipment, please contact DiaTecne s.r.l. at the following email address: info@pulsepen.com. You will
receive technical assistance in a short time.
Notes on recycling
DiaTecne s.r.l. is sensitive to environmental issues related to the production of waste.
The user that wishes to discard the device at the end of its service life, should contact DiaTecne s.r.l. and
will receive appropriate instructions.
Adequate waste selection before recycling and eco-compatible waste processing contribute to avoiding
detrimental effects on nature and on human health, and promote the reuse and recycling of the materials of
which the device is made.
Please note that improper disposal of the product may cause sanctions by the Country where this should
take place.
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Symbols and Abbreviations
Manufacturer information
It’s mandatory to read the User Manual before using the apparatus
⚠ Warning: pay attention
Class II device
Applied parts are of type BF
The device incorporates radio frequency transmitters (not ionizing radiations)
The product must be discarded as electronic waste, separately from other waste, at the end of its
service life
SN: each unit is identified with a serial number.
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User Manual PulsePen - V. 4.6
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Index
page
Document printing:
It’s possible to print more copies of this document in the following way:
•
open the “pdf” file of this manual with Adobe Reader or similar
•
select options “booklet”, “both sides”, “left binding ”, “page size A4", “vertical orientation”
•
print both sides, fold and bind as shown:
Note: with the purpose of a continuous product improvement, Diatecne s.r.l. reserves the right to make any
changes it deems necessary, without notice, both to this manual and to the PulsePen device,
communicating these changes only to the competent bodies.!
Composition 1
Tonometric unit: wTn1 2
ECG unit: wEc1 2
Signal Receiver unit: wRs1 2
Intended Use 3
Technical Specifications 4
Classification 4
Computer Connection 4
Software Installation 4
Use of the device 5
Maintenance and Cleaning 8
Warnings and Precautions for Use 8
Reciprocal Interferences with other Equipments 9
Tab. 1: Electromagnetic Emissions 10
Tab. 2: Electromagnetic Immunity 10
Tab. 3: Electromagnetic Immunity 11
Tab. 4: Immunity to proximity fields from RF wireless communication equipments 12
Problems during use and solutions 13
Notes on recycling 13
Symbols and Abbreviations 14
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User Manual PulsePen - V. 4.6
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PulsePen® is a trademark of DiaTecne s.r.l. - Italy ______ Copyright © 2014 - 2019 - V. 4.6 Eng / Jan. 2019
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User Manual PulsePen - V. 4.6
DiaTecne s.r.l.
Via G. di Vittorio, 190
20097 - S. Donato Milanese
(Milano) - Italia
PulsePen
Ref: WPP001-ET SN:
0051
DiaTecne s.r.l.
Via G. di Vittorio, 190
20097 - S. Donato Milanese
(Milano) - Italia
PulsePen
Ref: WPP001-ETT SN:
0051
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