I.【System Operation】
1. Turning on a main device
2.1 Connecting a cassette to a commercial micro-collection tube recommended
in this user manual. Please refer to the pictures below:
2. Assembling steps
2.2 Connecting the cassette to the main device. Please refer to the picture below:
M.【MANUFACTURERʼS declaration ‒ Electro-
magnetic Compatibility ‒ for all ME EQUIP-
MENT and ME SYSTEMS】
Manufacturerʼs declaration-electromagnetic immunity
The WH-001 is intended for use in the electromagnetic environment (for profe-
ssional healthcare) specified below.
The customer or the user of the WH-001 should assure that it is used in such
an environment.
Immunity
Test
IEC 60601
Test Level
Compliance
Level
Electromagnetic
environment-
guidance
(for professional
healthcare
environment)
Electrostatic
discharge(ESD)
IEC 61000-4-2
Floors should be wood,
concrete or ceramic tile.
If floors are covered with
synthetic material, the
relative humidity should
be at least 30%
Contact:
±
8 kV
Air
±
2 kV,
±
4 kV,
±
8 kV,
±
15 kV
Contact:
±
8 kV
Air
±
2 kV,
±
4 kV,
±
8 kV,
±
15 kV
Electrical fast
transient/burst
IEC 61000-4-4
Mains power quality
should be that of a typical
professional healthcare
environment.
±
2 kV for power
supply lines
±
1 kV for input/
output lines
±
2 kV for power
supply lines
Not applicable
Surge
IEC 61000-4-5
±
0.5 kV,
±
1 kV
line(s) to line(s)
±
0.5 kV,
±
1 kV,
±
2 kV
line(s) to earth
±
0.5 kV,
±
1 kV
line(s) to line(s)
Not applicable
Mains power quality
should be that of a typical
professional healthcare
environment.
Voltage Dips,
short interrup-
tions and vol-
tage variations
on power supp-
ly input lines
IEC 61000-4-11
Voltage dips:
0 %
; 0.5 cycle
0 %
; 1 cycle
70 %
; 25/30 cycles
Voltage interruptions:
0 %
; 250/300 cycle
Voltage dips:
0 %
; 0.5 cycle
0 %
; 1 cycle
70 %
; 25/30 cycles
Voltage interruptions:
0 %
; 250/300 cycle
Mains power quality
should be that of a typical
professional healthcare
environment.
If the user of the WH-001
requires continued opera-
tion during power mains
interruptions, it is recom-
mended that the WH-001
be powered from an unin-
terruptible power supply
or a battery.
Power frequency
(50, 60 Hz)
magnetic field
IEC 61000-4-8
30 A/m
50 Hz or 60 Hz
30 A/m
50 Hz
The WH-001 power fre-
quency magnetic fields
should be at levels cha-
racteristic of a typical lo-
cation in a typical profe-
ssional healthcare envi-
ronment.
NOTE
is the a.c. mains voltage prior to application of the test level.
Parallelly
Push it in parallelly
K.【Adverse Event Notification】
In the event that there is an unexpected accident or defective product, please
notify the European authorized representative of Winnoz Technology, Inc.:
MedNet EC-REP GmbH: Tel: +49 (0) 251 322 66-64; Fax: +49 (0) 251 322 66-22;
Email: [email protected]; Address: Borkstrasse 10, 48163 Muenster,
Germany.
L.【Troubleshooting】
1. Cause of issue： there is no airtight at the interfaces stated below
2. Troubleshooting：
(a) Please confirm that the micro-collection tube is correctly aligned with the
cassette, and the O-ring of the cassette should not be deformed.
(b) Please check if the cassette is secured accurately and firmly to the main
device. It is recommended to re-insert the cassette into the main device and
push the cassette inward to the main device slightly.
(c) Please adjust the position of your fingertip to make sure the Blood
Collection Entry is correctly covered. If your fingertip cannot cover the Blood
Collection Entry, it is suggested to try other fingers.
(d) A wet finger will affect the airtight of the system. Please dry your finger
before the blood collection process if you washed your hands or use an
alcohol pad to disinfect your fingertip.
(e) Please make sure that your fingertip does not apply pressure on the
cassette. It is recommended to rest your arm and wrist on a desk or a support
object.
(f) If the issue cannot be solved after the above procedures, please contact
the customer service provided by Winnoz Technology, Inc.
Scenario 1
The Indicator Lights do not turn from yellow to blue in 3-10 seconds after
pressing the Start-Button.
In order to well operate this product, please read the following instructions and
corresponding pictures carefully:
1.1 Connecting a main device and a power adapter (GEM12I12-P1J) through
the Power Adapter Connector.
1.2 Connecting the power adapter to a power outlet having a suitable range
of Input Rating stated in Section E.
1.3 Moving the Switch to the ON position.
To ensure airtight during the blood collection process, please confirm that
the angle of the micro-collection tube open end is correctly aligned with
the specific design angle of the Tube Connector of the cassette. Please note
that the O-ring should not be deformed when assembling.
(1) Please insert the cassette into the main device and do not tilt the
cassette when inserting.
(2) To ensure the cassette is installed firmly, please push the cassette
inward to the main device.
(1) Wash and dry your hands.
(2) Select a finger to be pricked and put on the Blood Collection Entry (Section G,
2.1). Please keep relaxing your finger to avoid unnecessary pressure enforced on
the cassette and resting your wrist and arm on a desk or a supportable object.
Please note that the user does not need to prick the finger at this step. For
choosing a finger to be pricked, please refer to step 4 of this Section.
(3) Press the Start-button, and you would hear machinery sound, feel suction at
your fingertip, and observe that the Indicator Lights changes from green to
yellow and then to blue in 3-10 seconds, indicating the system has successfully
entered into the blood collection mode. If succeed, please press the Start-button
again for 1 second to stop the process and proceed step 4 to step 6 of this Section
for the blood collection. Otherwise, please refer to Scenario 1 of Section L for
troubleshooting.
3. Checking airtight of the system
Before conducting the blood collection process, the user shall check the airtight
of the system by inspection if the micro-collection tube along with the cassette is
correctly installed on the main device per the following instructions:
5. Blood collection procedure
J.【Cleaning and Disinfecting】
1. Although the user needs to operate the main device with clean disposable
gloves, it is still recommended to clean and disinfect the main device.
2. Please confirm that the main device is not connected to any power source
before cleaning and disinfecting it.
3. Please clean and disinfect the main device before and after each userʼs use,
and once there is any dirt or blood on the main device.
4. Please use one of the following cleaning materials:
(a) A clean gauze, cotton swab, or any functional analogue, moistened
with a cleaning agent, including but not limited to, CaviCide,
MEDASEPT® 100 or any similar CE-marked medical device (without
hypochlorous acid and its derivatives) applying to disinfection.
(b) An available commercial disinfection product, including but not
limited to, CaviWipes, Super Sani-Cloth Plus or any similar CE-marked
medical device (without hypochlorous acid and its derivatives).
(c) Activity spectrum of the recommended cleaning agents:
5. Cleaning and disinfecting procedure:
(a) Wear clean disposable gloves.
(b) Clean the exterior surface with a cleaning material aforementioned.
(c) Clean the Cassette Connector using a cotton swab moistened with a
cleaning agent aforementioned.
(d) If the cleaning material is stained, repeat above step 5(b) or 5(c) with
a new cleaning material.
(e) Stand and air-dry the cleaned area.
6. CAUTIONS of the cleaning and disinfecting procedure
(a) Before using any cleaning materials aforementioned, please carefully
read the IFU of the cleaning material to be used.
(b) AVOID getting any moisture or dirt into any openings of the main
device.
(c) DO NOT spray any cleaning agent directly onto the main device.
(d) DO NOT use any organic solvents to clean the main device.
6. After completing blood collection
Remove the
fingertip from
the cassette
Retrieve the
cassette and
disconnect the
micro-collection
tube
Proceed with a
specimen
testing based
on needs
1
2
3
4
Cover the cap.
If applicable,
mix the specimen
with the
anticoagulant
1
Select a fingertip
to be pricked
Priority
1
2
3
1
2
3
＞
＞
2
Massage the finger
from bottom to top
for 3 times
x3
Make the fingertip
congested until it
is pricked
3
Disinfect
the fingertip
4
5
Prick the fingertip
at the Suggested
Area
Wipe off the
first drop of blood
6
Press the Start-
Button and avoid to
apply pressure on
the cassette
[Note]
9
Massage the finger
from bottom to top
until a blood drop
appears
7
Gently place the
puncture site right
above the Blood
Collection Hole
8
4. Finger selection priority
The recommended priority of fingers for blood drawing are follows: ring finger >
middle finger > index finger. Please note that the fingertipʼs size and elasticity will
affect the efficacy of blood collection. The fingertip's size is larger and the
fingertip is more pliable, the efficacy of blood collection will be improved. The
general order of fingertip size is as shown: middle finger > index finger ≈ ring
finger. It is not recommended to use a fingertip having calluses. Users can choose
fingers dependent on their physical conditions.
[Note]: Please relax your finger and rest your wrist and arm on a desk or a support-
able object.
Cassette
The cassette is single-use disposable. Please discard it as a biological waste
according to local authority regulations.
Main Device
-4-
1. If the system does not run properly
Generally, once a fingertip is properly placed on the Blood Collection Entry of a
cassette and the Start-Button is pressed, the Indicator Lights will first turn from
the green color to the yellow color, indicating that the main device will start to
produce negative pressure. In 3-10 seconds, the Indicator Lights will turn from the
yellow color to the blue color, stating that the negative pressure reaches the
preset value and the blood collection process starts. The Indicator Lights will
maintain at blue color for 2 minutes to complete the blood collection process,
and then the main device will go back to the standby mode.
If the colors of Indicator Light do not change according to the above statements
or the main device stops during the blood collection process, please refer to the
following scenarios for troubleshooting.
(a) The cassette and the micro-collection tube.
(b) The Main Device Connector of the cassette and the Cassette Connector of
the main device.
(c) Userʼs fingertip and the Blood Collection Entry of the cassette.
1. Cause of issue： a not airtight status suddenly caused between the fingertip and
the assembled cassette.
2. Troubleshooting：
(a) Please adjust the position of your fingertip to make sure the Blood
Collection Entry is correctly covered. If your fingertip cannot cover the Blood
Collection Entry, it is suggested to try other fingers.
(c) Please make sure that your fingertip does not apply pressure on the
cassette. It is recommended to rest your arm and wrist on a desk or a support
object.
(d) If the issue cannot be solved after the above procedures, please contact
the customer service provided by Winnoz Technology, Inc.
(e) If you need to stop the process, please press the Start-Button for 1 second.
Scenario 2
During the blood collection process, the Indicator Lights turn from the
blue color to the yellow color.
2. If the user could not collect enough blood volume or quality blood
Due to multiple heterogeneous factors such as age, microvascular distribution,
blood circulation, atmospheric pressure, etc., the blood volume collected with the
product could vary in different scenarios. Notwithstanding, when sufficient blood
specimens cannot be collected, please try the following methods to obtain more
blood or seek specialized medical assistance or try other blood collection
methods.
(a) Before blood collection, it is recommended that you warm and massage your
fingers properly.
(b) According to experimental data, hyperhidrosis and hypotension may affect
the blood volume collected because a wet finger will affect the airtight of the
system. Please dry your finger before the blood collection process if you washed
your hands or use an alcohol pad to disinfect your fingertip.
(c) If you had applied hand cream on your hand, please wash it away and dry
your fingers as it may contaminate the blood specimen.
(d) The airtight of the system affects the collected blood volume. Please confirm
the system is airtight before blood collection by following the instructions in the
scenario 1 of Section L.
(e) When operating this product, it is necessary to use a blood lancet with a
needle (diameter ≥ 0.8 mm, gauge number ≤ 21G) or a blade (width ≥ 1.5 mm).
In addition, using a lancet whose diameter or width is smaller than that of 21G
would increase hemolysis risk.
(f) Suppose blood cannot be successfully collected after following the customer
serviceʼs guidance and confirming that the product functions normally and has
been operated correctly, the product may not be applicable to this user.
-5-
IFU-1801
EN 2020-09 rev.5.7
-6-
The WH-001 is intended for use in the electromagnetic environment (for profe-
ssional healthcare) specified below.
The customer or the user of the WH-001 should assure that it is used in such
an environment.
Immunity
Test
IEC 60601
Test Level
Compliance
Level
Electromagnetic
environment-
guidance
(for professional
healthcare
environment)
Manufacturerʼs declaration-electromagnetic immunity
NOTE 1
At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2
These guidelines may not apply in all situations. Electromagnetic propagation
is affected by absorption and reflection from structures, objects and people.
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms:
0.15 MHz - 80 MHz
6 Vrms:
in ISM bands between
0.15 MHz and 80 MHz
80 % AM at 1 kHz
3 V/m
80 MHz ‒ 2.7 GHz
80 % AM at 1 kHz
3 Vrms:
0.15 MHz - 80 MHz
6 Vrms:
in ISM bands between
0.15 MHz and 80 MHz
80 % AM at 1 kHz
3 V/m
80 MHz ‒ 2.7 GHz
80 % AM at 1 kHz
Portable and mobile RF
communications equipment
should be used no closer to
any part of the WH-001
including cables, than the
recommended separation
distance calculated from the
equation applicable to the
frequency of the transmitter.
Recommended separation
distance:
= 1.2 √
= 1.2 √ 80MHz to 800 MHz
= 2.3 √ 800MHz to 2.7 GHz
Where
is the maximum
output power rating of the
transmitter in watts (W) accor-
ding to the transmitter manu-
facturer and
is the recom-
mended separation distance
in metres (m).
Interference may occur in the
vicinity of equipment marked
with the following symbol:
Suggested Area
(+: the center of
the fingerprint)
Recommended reaction time
MEDASEPT®
100
Super Sani-
Cloth Plus
30 sec.
30 sec.
30 sec.
30 sec.
1 min.
1 min.
N.A.
2 min.
30 sec.
5 min.
N.A.
1 min.
N.A.
N.A.
30 sec.
30 sec.
30 sec.
30 sec.
30 sec.
30 sec.
15 sec.
15 sec.
15 sec.
15 sec.
N.A.
N.A.
3 min.
3 min.
N.A.
30 sec.
N.A.
N.A.
Activity
Spectrum
CaviCide/
CaviWipes
Bactericidal
Fungicidal
Virucidal
Mycobactericidal
/
Tuberculocidal
Pseudomonas aeruginosa
Staphylococcus aureus
Enterococcus spp.
(incl. VRE)
MRSA
3 min.
3 min.
3 min.
3 min.
Candida albicans
Aspergillus brasiliensis
Trichophyton mentagrophytes
1 min.
1 min.
3 min.
HBV/HCV/HIV
Influenza A2/H1N1/H5N1
Vaccinia virus
Coronavirus
HSV-1/HSV-2
BVDV
2 min.
2 min.
2 min.
2 min.
2 min.
2 min.
Mycobacterium terrae
Mycobacterium avium
Mycobacterium bovis
1 min.
1 min.
3 min.
Note
N.A. is for Not Available.
