“Haiim” Vacuum-assisted blood
collection system
Please read this instruction manual carefully
before operating this product.
User Manual
A.【Product Description】
This product, “Haiim” Vacuum-assisted blood collection system (WH-001), is
composed of two parts: 1) a main device (HD-001) and 2) a single-use disposable
cassette (HC-001). The main device includes a pressure control system that
generates negative pressure to create a vacuum effect for collecting blood. The
intended purpose of the product is limited to IVD use only. 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) and a micro-collection tube
(the information of compatible micro-collection tubes is provided in Section E,
Cassette (HC-001) General Specifications).
(1) Main Device
(2) Cassette
(3) Micro-
collection tube
(4) Lancet
White light:
Green light:
Blue light:
2. Cassette （HC-001）
2.1 Blood Collection Entry: an open end of the cassette on where a fingertip
should be placed.
2.2 Main Device Connector: a connector for connecting to the Cassette
Connector.
2.3 Tube Connector: a connector with a specific design angle for connecting to
a commercial micro-collection tube recommended in this user manual.
2.4 O-ring.
2.5 Blood Collection Hole: the top entry of the capillary structure of the
cassette for receiving blood specimens from a fingertip.
2.3 Tube Connector
2.1 Blood Collection Entry
2.2 Main Device
Connector
H.【Preceding Operation】
Before starting, please prepare the following items:
B.【Intended Use】
C.【Contraindications】
“Haiim” Vacuum-assisted blood collection system is intended to use a vacuum to
collect capillary blood from a puncture site. The product is composed of a
cassette able to connect with a single-use micro-collection tube and a main
device providing a pressure control function. When assembled and activated, the
product collects blood from the puncture site to the micro-collection tube. This
product is for professional use only.
1. Diseases that are associated with blood coagulation disorders or need to take
any anti-coagulation medication/treatment may cause abnormal blood loss.
2. Areas of skin infection or skin conditions like cellulitis or abscess should be
avoided because of the risks of inoculating the blood with bacteria, viruses, and
any substance that caused infection.
D.【Warnings and Precautions】
1 . P r o d u c t S a f e t y
1.1 Before starting to use this product, please confirm if the standard voltage of
the country or region where you are going to use the product is in the range of
the technical specifications of the power adapter provided in Section E of this user
manual.
1.2 Before starting to use this product, please verify that the product has complete
packaging shown in Section F. If there is any missing part, please kindly return the
whole product to where you purchased it from for a replacement.
1.3 Do not apply any physical impact to the main device and avoid it from falling.
1.4 This product can be used in a professional healthcare environment.
1.5 This product is not intended for use in residential environments and may not
provide adequate protection to radio reception in such environments.
1.6 The product should not be used adjacent to or stacked with other equipment.
1.7 Do not insert anything into the connectorsʼ holes or the outer case gaps of the
main device.
1.8 Do not place the product in a location accessible to children or unauthorized
users.
3 . I n s t r u c t i o n s f o r S a f e B l o o d D r a w i n g
3.1 Before starting to use this product, please read this user manual carefully and
other documents provided along with the product.
3.2 This product has been designed for fingertip blood collection. Please do not
give it any other uses.
3.3 Only medical or healthcare providers are eligible to operate this product in
accordance with local regulations.
3.4 The main device can only be used with the cassettes. Please do not use any
other goods similar to the cassettes.
3.5 The cassette is a single-use consumable. Please do not reuse it.
3.6 Do not use any cassette whose individual packaging is damaged or perforat-
ed to avoid any risks of contamination.
3.7 Do not start to operate this product until the cassette has been correctly
installed.
3.8 For emergencies or accidents during blood drawing, please refer to the
system operation setting stated in Section E of this user manual.
3.9 Users should prepare other items that may be required for blood drawing
according to Section H (e.g., gloves, alcohol pads, etc.).
3.10 Since blood is a high-risk biological specimen, it is important to take proper
precautions every time when performing the blood collection process. Users
shall avoid directly touching the wounds or any areas with blood.
3.11 Do not inject the collected blood specimen back into anyone's body to
avoid infection or further risks.
3.12 Usage of this product performing by a person unable to properly operate
the product due to color blindness, blindness, or blurred vision shall be avoided.
3.13 Please comply with local authority regulations and use appropriate biologi-
cal waste disposal protocols to dispose of used cassettes and other consumables
that have been used or that have been in contact with blood specimens. Regard-
ing the disposal of the main device, please follow your national requirements.
4 . C l e a n i n g a n d M a i n t e n a n c e C o n s i d e r a t i o n s
4.1 Please avoid dust, dirt, or other contaminants enters the Cassette Connector
of the main device (see section G, 1.4) or accumulated on the main device
surfaces.
4.2 The main device shall be cleaned regularly, especially when it has been in
contact with blood specimens, to prevent the risk of cross-contamination. For
more details, please refer to the Section J of this user manual.
4.3 It is forbidden to disassemble or alter completely or partially both the main
device and the cassette. If so, the functionality and safety of this product are not
assured.
4.4 If the product requires maintenance, please contact the customer service
provided by Winnoz Technology, Inc.
E.【Items and Specifications】
“Haiim” Vacuum-assisted blood collection system
Main Device(HD-001)
General Specifications
F.【Product Images】
The complete packaging of “Haiim” Vacuum-assisted blood collection system
is shown below:
1. Main device (HD-001), including Power Adapter (GEM12I12-P1J)
EMC Standards
· Conducted Emission (IEC 60601-1-2:2014)
· Radiated Emission (IEC 60601-1-2:2014)
· Harmonic distortion (IEC 60601-1-2:2014)
· Voltage fluctuations and flicker (IEC 60601-1-2:2014)
· ESD (IEC 60601-1-2:2014)
· RS Radiated RF EM fields (IEC 60601-1-2:2014)
· RS Proximity fields from RF wireless communications
equipment (IEC 60601-1-2:2014)
· EFT (IEC 60601-1-2:2014)
· Surge (IEC 60601-1-2:2014)
· CS (IEC 60601-1-2:2014)
· PFMF (IEC 60601-1-2:2014)
· Voltage dips and interruptions (IEC 60601-1-2:2014)
Dimension
Weight
Recommended
Micro-collection
Tube
Specification
Compatible
Device
Packaging
Operating
Condition
Shelf Life
Width: 18 mm/Length: 32.5 mm/Height: 42 mm
(excluding the height of the assembled micro-
collection tube)
4 g (Net weight)
1. BD Microtainer® Tube with BD Microgard™ Closure
0.5 mL (Without gel)
2. EV Single-use Containers for Human Capillary Blood
Specimen Collection 0.5 mL (Without gel)
It is not recommended to use a micro-collection tube
with gel.
“Haiim” Vacuum-assisted blood collection system.
Main Device (HD-001)
Single package (non-sterile)
Temperature range：0~40℃
Humidity range: 30~75 % RH
3 years
Dimension
Weight
System
Operation
Setting
Power Adapter
Specifications
Compatible
Cassette
Operating
Conditions
Storage
Conditions
Width: 62 mm/Length: 123 mm/Height: 62 mm
219 g (net weight)
- Press the Start-Button (Section G, 1.3) to start.
- To stop the main device when functioning in case
of emergency or accidents, press the Start-Button
for one second.
- Automatic cycle time: 2 min
Model: GEM12I12-P1J
Input Rating: 100-240 VAC, 50-60 Hz, 0.4-0.2A
Output Rating: 12 Vdc/1A
Cable Length: 1.8 m
Weight: 118 g
“Haiim” Vacuum-assisted blood collection system
Cassette (HC-001)
Temperature range：0~40℃
Humidity range: 30~75% RH
Temperature range：0~40℃
Humidity range:30~75% RH
Avoid direct exposure to sunlight
Item Name
Model
Remarks
“Haiim” Vacuum-assisted
blood collection system
User Manual
Main Device
Cassette
Power adapter
Accessory
Accessory
“Haiim” Vacuum-assisted blood collection system
Cassette (HC-001)
General Specifications
2. Cassette (HC-001)
Yellow light:
2 . E l e c t r i c a l S a f e t y
2.1 Only use a power adapter having the model stated in Section E of this user
manual. Any power adapter having a model different from the aforementioned
model is prohibited.
2.2 Please do not use any other cables or accessories not approved by the
manufacturer in this user manual to avoid negative influence on electromagnetic
compatibility.
2.3 Do not connect this product to electric sockets with wet hands.
2.4 If abnormal behavior is observed due to EM disturbances, please relocate the
main device accordingly.
2.5 There may be an interaction between the product and an electric equipment
due to electromagnetic radiation. Itʼs recommended a safety distance of at least
30 cm between the product and electric equipment, especially sensitive
equipment.
2.6 This Product is medical electrical equipment that needs special precautions
regarding EMC and needs to be installed according to the EMC information
provided.
-1-
-2-
1.1 Power Adapter Connector
1.2 Switch
1.3 Start-
Button
1.5 Indicator Lights
1.4 Cassette
Connector
ON
OFF
ON
OFF
1.1. Power Adapter Connector: a connector shall be connected to a power adapter
(GEM12I12-P1J) to have power input before blood collection.
1.2. Switch: the switch of the main device. By moving Switch, the main device
could be turned on or off.
1.2.1. ON position.
1.2.2. OFF position.
1.3. Start-Button: a button for starting a blood collection process by gently press. In
case of emergency or accidents, press again the Start-Button for 1 second to stop
the blood collection process.
1.4. Cassette Connector: a connector for connecting to the Main Device Connector.
1.5. Indicator Lights: the indicator lights consist of three LED lights, showing
different colors corresponding to different status as described below:
1. Main Device (HD-001)
G.【Description of Key Items】
The function of each key item of the Product as labeled and briefly described
below:
-3-
1.2.1
1.2.2
The Indicator Lights show the white color
right after powering on the main device. Then,
the Indicator Lights will turn to the green
color and go into standby mode.
Standby mode.
The Indicator Lights are green when the main
device is in a normal condition, and is not
collecting blood.
The yellow color means negative pressure
does not reach the preset value.
The Indicator Lights first show the yellow
color once pressing the Start-Button. If the
pressure does not reach the preset value
within 10 seconds, the Indicator Lights will
turn to the green color, and the main device
will go back to the standby mode. Please refer
to Scenario 1 of Section L for troubleshooting.
Blood collection mode. When the negative
pressure reaches the preset value, the Indicator
Lights will turn from the yellow color to the
blue color and maintain at blue for 2 minutes to
complete the blood collection process.
If the Indicator Lights turn from the blue color
to the yellow color during the blood collection
process, please refer to Scenario 2 of Section L
for troubleshooting.
2.4 O-ring
2.5 Blood Collection Hole
A specific design
angle of the
Tube Connector
(6) Gloves
(7) Alcohol pad,
or other consuma-
bles for disinfection
(8) Cotton swab
(9) Cotton ball, or
other hemostatic
consumables
Storage
Conditions
Temperature range：0~40℃
Humidity range:30~75% RH
Avoid direct exposure to sunlight
(5) Wrist pad
®
