Gima QV-600 User manual

1
RILEVATORE DI VENE PROFESSIONALE QV-600
QV-600 PROFESSIONAL VEIN FINDER
M23454-M-Rev.0-04.23
PROFESSIONAL MEDICAL PRODUCTS
Qualmedi Technology Co.
Ltd. A302 Room, No. 23, HangBu Road,
Feixi County Economic Development Zone, Hefei
City, Anhui Province, China.
Made in China
QV-600 (GIMA 23454)
Kingsmead Service
B.V. Zonnehof 36, 2632 BE,
Nootdorp, Netherland
• È necessario segnalare qualsiasi incidente grave vericatosi in relazione al dispositivo medico da noi
fornito al fabbricante e all’autorità competente dello Stato membro in cui si ha sede.
• All serious accidents concerning the medical device supplied by us must be reported to the
manufacturer and competent authority of the member state where your registered office is located
MANUALE D’USO – USER MANUAL
Gima S.p.A.
Via Marconi, 1 - 20060 Gessate (MI) Italy
[e-mail] - [e-mail]
www.gimaitaly.com

10
ENGLISH
QV-600 VEIN FINDER - V3.1
PLEASE READ THIS OPERATION MANUAL
CAREFULLY
BEFORE OPERATING THE VEIN FINDER
Intended Use
Vein nder can help medical professionals to locate
certain supercial veins.This equipment is intended
to be used as a supplement to appropriate medical
training and experience. It should not be used as
the sole method for locating veins. And should be
used only by a qualied medical professional, who
should do so either prior to palpation to help identi-
fy the location of a vein, or afterwards to conrm or
refute the perceived location of a vein. When using
the device, medical practitioners should always fol-
low the appropriate medical protocols and practi-
ces as required by their medical facility, as well as
exercise sound medical judgment.
When used properly, it enables users to locate cer-
tain supercial veins in connection with medical
procedures, such as venipuncture.
This vein nder can be used whenever the deter-
mination of vein location is appropriate such as ho-
spitals and clinics.
Product Description
Vein nder operates by using infrared light to detect
veins beneath the skin, then projecting the position
of the veins on the skin surface directly above the
veins. Qualied medical personnel can observe the
vasculature as displayed to assist them in nding a
vein of the right size and position for venipuncture
and other medical procedures requiring the loca-
tion of supercial veins. No training is required to
operate this device.
The device only shows supercial vasculature. The
maximum depth that veins are displayed varies by
patient. In addition, some patients’ veins or a por-
tion of their veins might not be displayed well or at
all. Causes for less than optimal or lack of vein di-
splay include, but are not limited to, vein depth, skin
conditions (e.g., eczema, tattoos), hair, scarring or
other highly contoured skin surface, and adipose
(fatty) tissue.
When held directly overhead, the device accurately
locates the center of a vein. Increasing the displa-
cement from directly overhead results in an offset
in the displayed vein position. Width of displayed
vein may differ from the actual width depending on
patient to patient differences and vein width. The
center line of the vein is accurate when the devi-
ce is being used correctly and should always be
used as the target when performing venipuncture
or other medical procedures.
Vein nder is portable machine. And the optional is
table stand and mobile stand.
Use and Operation
Hold the device from 15 to 25 cm over the surface
of the skin.
Scan the area of interest to view.
Once a vein is selected, make sure the vein display
light is centered directly above the vein’s center line.
Tilting the device to either side of the vein will offset
the projected vein from its true location beneath the
skin.
You can often enhance display quality by slightly
adjusting the height and angle to the skin.
In particular, moving the device closer or further
from the skin can help bring additional veins into
view, depending on the patient’s vasculature, room
lighting, and depth of the veins.
While the vein display light is on, shine the device
over the patient’s skin.
You can do this before palpation, use sport mode
scanning quickly over the skin to help narrow down
possible locations.
After conrming suitable vein location, you can
change to enhance mode to nd the deep veins.
After assessing the patient’s vasculature, conrm
the site for your procedure by verifying the location
and suitability of the vein using normal medical
techniques and good medical judgment, such as
vein visualization, palpation, and other medical te-
chniques

11 ENGLISH
Operating Instructions
LCD User Interface
Key
Power, Sleep, OK, and Four Arrow Key
Key Power Short press the button to startup or shutdown. Automat-
ic power o󰀨 when machine idle for 35 minutes.
Light indicator:
Blue: Working; Green: Fully charged; Red: Charging
Key Sleep
Machine enter sleep mode automatically when idle for
10mins(default) or set idle time by LCD interface. Short
press make machine enter low energy consumption mode
immediately.
LCD Color Using the up and down arrow keys, select row “Color” in LCD and press the “OK”
key or the left and right arrow keys to choose appropriate color.
LCD Size Using the up and down arrow keys, select row “Size” in LCD and press the “OK”
key or the left and right arrow keys to choose appropriate size.
LCD
Inverse
Using the up and down arrow keys, select row “Inverse” in LCD and press the
“OK” key or the left and right arrow keys to turn on/o󰀨 inverse mode.
LCD
Brightness
Using the up and down arrow keys, select row “Brightness” in LCD and press the
“OK” key or the left and right arrow keys to choose appropriate brightness.

12
ENGLISH
LCD
Enhance
Using the up and down arrow keys, select row “Inverse” in LCD and press
the “OK” key or the left and right arrow keys to turn on/off enhance mode.
LCD
Photograph
Using the up and down arrow keys, select row “Photograph” in LCD and
press the “OK” key or the left and right arrow keys to save real-time vein
images. Captured veins can be accessed by computer through Type-C
cable.
LCD Sleep Using the up and down arrow keys, select row “Sleep” in LCD and press
the “OK” key or the left and right arrow keys to set sleep idle time.
How to change
language
Press “Sleep button” and “direction Down button” at the same time, for
3 seconds. Enter in the “developer mode”, then select language (10
languages available) pushing “OK”
Technical parameters
Infrared light detection without harm to human body
Infrared Wave: 760-940nm
Infrared detection depth: 0-10mm
Best detection distance: 15-25cm
Accuracy of blood vessel position: ±0.3mm
Accuracy of blood vessel resolution: ±0.3mm
Low working noise: ≤40DB
The battery capacity can be displayed.
Low Battery capacity prompt.
Samsung 5000mAh rechargeable lithium battery, 3 hours duration.
TI DLP projection technology.
Power supply of charging: 5V 4,5A, 100V-240V 50Hz-60Hz
Size: 23(L)*6.4(W)*5.7(H)cm

13 ENGLISH
Packing List
No Name Quantity
1 Main Machine 1
2 Charging cable 1
3 Charging adapter 1
4 Aluminum Carrying Case 1
5 User’s manual 1
6 Calibration card 1
7 Product certication 1
8 Warranty card 1
Maintenance
- Maintain and clean the device once a month.
- Please unplug power cable and make sure device
is off before cleaning.
- Please use the dust-free cloth to dip concentra-
tion of 70% alcohol to wipe the device.
- Should be returned to factory for servicing if the
vein light window is scratched.
- If you do not use the device for more than 3 mon-
ths, please remove the battery from Device.
- This device is with Independent battery compart-
ment. It is easy to take out the battery.
- Please do not open the device to clean the inner
of the machine.
- After using, please put the device to aluminum
carrying case.
- Please store in a dry and cool place
Warning and Cautions
This vein nder should be used as a supplement
for qualied professionals to determine the location
of the veins.
This vein nder is dependent on a variety of patient
factors and may not display veins on patients with
deep veins, skin conditions, hair, scarring or other
highly contoured skin surface, and adipose (fatty)
tissue.
This vein nder displays only supercial veins and
does so only to limited depths dependent on a va-
riety of patient factors.The device does not indicate
vein depth.
This vein nder should not be used to locate veins
in the eyes.
Do not shine vein display light to the eyes for a long
time.
The device projection may not display veins if ope-
rated under bright light such as bright sunlight.
This vein nder is not intended to be used as a dia-
gnostic device or for treatment of any kind.
Keep the instrument dry and clean to prevent any
uid from entering the machine.
This vein nder must be repaired by authorized and
qualied staff.
Do not attempt to open, disassemble, or service the
battery.
Do not attempt to sterilize the device with heat or
pressure sterilization.
Electromagnetic Interference can affect the perfor-
mance of the device.
The Machine is fragile, do not falling.
Using unofficial accessories can reduce safety, so
use only official accessories.
Do not throw this vein nder and battery to re
Any serious incident that has occurred in relation to
the device should be reported to the manufacturer
and the competent authority of the Member State
in which the user and / or patient is established
Guidance and Manufacturer’s Declaration Electromagnetic Immunity
IEC 60601-1-2
The Vein Finder is suitable for use in the specied electromagnetic environment.The customer and/
or the user of the Vein Finder should assure that it is used in an electromagnetic environment as
described below:
Emissions Test Compliance Electromagnetic Environment Guidance
RF emissions CISPR 11 Group 1 The Vein Finder uses RF energy only for its
internal function. Therefore, its RF emissions
are very low and are not likely to cause any
interference in nearby electronic equipment.

14
ENGLISH
RF emissions CISPR 11 Class B The Vein Finder is suitable for use in all
establishments, including domestic establish-
ments 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 Class A
Voltage uctuations/ icker
emissions IEC 61000-3-3 Complies
Guidance and Manufacturer’s Declaration Electromagnetic Immunity
IEC 60601-1-2
The Vein Finder is suitable for use in the specied electromagnetic environment.The customer and/
or the user of the Vein Finder should assure that it is used in an electromagnetic environment as
described below:
Immunity Test IEC 60601-1-2
Test Level
Compliance Level Electromagnetic Environment
Guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
± 6 kV contact
± 8 kV air
± 6 kV contact
± 8 kV air
Floors should be wood, concrete,
or ceramic tile. If oors are
covered with synthetic material,
the relative humidity should be at
least 30%.
Electrical fast
transient/burst IEC
61000-4-4
± 2 kV for power
supply lines
± 1 kV for input/
output
lines
± 2 kV for power
supply lines
± 1 kV for
input/output lines
Mains power quality should be
that of a typical commercial and/
or hospital environment
Surge IEC 61000-4-5 ± 1 kV
differential mode
± 2 kV
common mode
± 1 kV
differential mode
± 2 kV
common mode
Mains power quality should be
that of a typical commercial and/
or hospital environment.
Voltage
dips, short
interruptions
and voltage
variations on
power supply
input lines
IEC 61000-4-11
< 5% UT
(> 95 % dip UT)
for 0,5 cycle
40 % UT
(60 % dip in UT)
for 5 cycles
70 % UT
(30 % dip in UT)
for 25 cycles
< 5 % UT
(> 95 % dip in
UT) for 5 sec
< 5 % UT
(> 95 % dip in
UT) for 0.5 cycle
40 % UT
(60 % dip in UT)
for 5 cycles
70 % UT
(30 % dip in UT)
for 25 cycles
< 5 % UT
(> 95 % dip in
UT) for 5 sec
Mains power quality should be
that of a typical commercial and/
or hospital environment. If the
user of the Vein Finder requires
continued operation during
power mains interruptions, it
is recommended that the Vein
Finder be powered from an
uninterruptible power supply or a
battery.

15 ENGLISH
Power
frequency
(50/60 Hz)
magnetic eld
IEC 61000-4-8
3 A/m 0.3 A/m If image distortion
occurs, it may be
necessary to position
the Vein Finder further
from sources of power
frequency magnetic elds
or to install magnetic
shielding. The power
frequency magnetic eld
should be measured in
the intended installation
location to assure that it
is sufficiently low.
NOTE: UT is the a.c. mains voltage prior to application of the test level.
Guidance and Manufacturer’s Declaration Electromagnetic Immunity
IEC 60601-1-2
The Vein Finder is suitable for use in the specied electromagnetic environment.The customer and/
or the user of the Vein Finder should assure that it is used in an electromagnetic environment as
described below:
Immunity Test IEC
60601-1-2
Test Level
Compliance
Level
Electromagnetic Environment Guidance
Conducted RF
IEC 61000-
4-6
Radiated RF IEC
61000-
4-3
3 Vrms
150 kHz to
80 MHz
3 V/m
80 MHz to
2,5 GHz
3 Vrms
3 V/m
Portable and mobile RF communications
equipment should be used no closer to any
part of the Vein Finder, including cables, than
the recommended separation
distance calculated from the equation
appropriate for the frequency of the
transmitter.
Recommended Separation Distance
80 MHz to 800 MHz
800 MHz to 2,5 GHz
where P is the maximum output power rating
of the transmitter in watts (W) according
to the transmitter manufacturer and d is
the recom- mended separation distance in
metres (m).
Field strengths from xed RF transmitters,
as determined by an electromagnetic site
survey,a should be less than the compliance
level in each frequency range.b
Interference may occur in the vicinity of
equip- ment marked with the following
symbol:

16
ENGLISH
Recommended Separation Distances
between Portable and Mobile RF Communications Equipment and the Vein Finder
IEC 60601-1-2
Frequency of Trans-
mitter Equation Rated
Maximum Output Power
of Transmitter watts
150 kHz to 80MHz
Separation Distance
metres
150 kHz to 800MHz
Separation Distance
metres
800 MHz to 2,5
GHz
Separation Distance
metres
0.01 0,12 0,12 0,23
0.1 0,38 0,38 0,73
1 1,2 1,2 2,3
10 3,8 3,8 7, 3
100 12 12 23
For transmitters rated at a maximum output power not listed above, the separation distance can be
estimated using the equation in the corresponding column, where P is the maximum output power
rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reection from structures, objects, and People.

17 ENGLISH
Symbols
Follow instructions for use Imported by
Medical Device compliant with
Regulation (EU) 2017/745 Caution: read instructions (warnings) carefully
Serial number Type B applied part
Product code Date of manufacture
Authorized representative in the
European community Medical Device
Manufacturer Lot number
WEEE disposal Keep away from sunlight
Keep in a cool, dry place
GIMA WARRANTY TERMS
The Gima 12-month standard B2B warranty applies.
Disposal: The product must not be disposed of along with other domestic waste.
The users must dispose of this equipment by bringing it to a specic recycling
point for electric and electronic equipment