GIMA QV-600 Professional Vein Finder User Manual

QV-600 Professional Vein Finder
User Manual
PROFESSIONAL MEDICAL PRODUCTS

QV-600 PROFESSIONAL VEIN FINDER

• 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

Ltd. A302 Room, No. 23, HangBu Road,
Feixi County Economic Development Zone, Hefei
City, Anhui Province, China.
Made in China
****| Kingsmead Service
B.V. Zonnehof 36, 2632 BE,
Nootdorp, Netherland
| Gima S.p.A.
Via Marconi, 1 – 20060 Gessate (MI) Italy
[email protected] – [email protected]
www.gimaitaly.com

QV-600 VEIN FINDER – V3.1
PLEASE READ THIS OPERATION MANUAL CAREFULLY
BEFORE OPERATING THE VEIN FINDER

Intended Use

Vein finder can help medical professionals to locate certain superficial 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 qualified medical professional, who should do so either prior to palpation to help identify the location of a vein, or afterwards to confirm or refute the perceived location of a vein. When using the device, medical practitioners should always follow the appropriate medical protocols and practices as required by their medical facility, as well as exercise sound medical judgment.
When used properly, it enables users to locate certain superficial veins in connection with medical procedures, such as venipuncture.
This vein finder can be used whenever the determination of vein location is appropriate such as hospitals and clinics.

Product Description

Vein finder 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. Qualified medical personnel can observe the vasculature as displayed to assist them in finding a vein of the right size and position for venipuncture and other medical procedures requiring the location of superficial veins. No training is required to operate this device.
The device only shows superficial vasculature. The maximum depth that veins are displayed varies by patient. In addition, some patients’ veins or a portion of their veins might not be displayed well or at all. Causes for less than optimal or lack of vein display 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 displacement 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 device is being used correctly and should always be used as the target when performing venipuncture or other medical procedures.
Vein finder 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 confirming suitable vein location, you can change to enhance mode to find the deep veins. After assessing the patient’s vasculature, confirm 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 techniques

Operating Instructions

LCD User Interface

Key

Power, Sleep, OK, and Four Arrow Key

Key Power| | Short press the button to startup or shutdown. Automatic power off 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/off 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.
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

Packing List

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 concentration 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 months, please remove the battery from Device.
– This device is with Independent battery compartment. 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 finder should be used as a supplement for qualified professionals to determine the location of the veins.
This vein finder 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 finder displays only superficial veins and does so only to limited depths dependent on a variety of patient factors.
The device does not indicate vein depth.
This vein finder 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 operated under bright light such as bright sunlight.
This vein finder is not intended to be used as a diagnostic device or for treatment of any kind.
Keep the instrument dry and clean to prevent any fluid from entering the machine.
This vein finder must be repaired by authorized and qualified 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 performance 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 finder and battery to fire
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 specified 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:

internal function. Therefore, its RF emissions  are very low and are not likely to cause any interference in nearby electronic equipment.
RF emissions CISPR 11| Class B| The Vein Finder 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| Class A
Voltage fluctuations/ flicker 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 specified 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 floors 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) or 0,5 cycle
40 % UT
(60 % dip in UT) or 5 cycles
70 % UT
(30 % dip in UT) or 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.
Power frequency (50/60 Hz) magnetic field 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 fields or to install magnetic shielding. The power frequency magnetic field 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 specified 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  60601-1-2Test Level| Compliance Level| Electromagnetic Environment Guidance
---|---|---|---
Conducted RF IEC 610004-6
Radiated RF IEC 61000- 4-3| 3 Vrms 150 kHz to 80 MHz
3 V/m 80 MHz to 2,5 GHz| | 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 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 fixed 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:

Recommended Separation Distances
between Portable and Mobile RF Communications Equipment and the Vein Finder IEC 60601-1-2

Frequency of Transmitter Equation Rated Maximum Output Power of Transmitter watts| 150 kHz to 80 MHz
Separation Distance metres| 150 kHz to 800 MHz
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 reflection from structures, objects, and People.
Symbols

| Follow instructions for use
---|---
| Medical Device compliant with Regulation (EU) 2017/745
| Serial number
| Product code
| Authorized representative in the European community
| Manufacturer
| WEEE disposal
| Keep in a cool, dry place
| Imported by
| Caution: read instructions (warnings) carefully
| Type B applied part
| Date of manufacture
| Medical Device
****| Lot number
| Keep away from sunlight

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 specific recycling point for electric and electronic equipment

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