GIMA QV-500 Professional Vein Finder User Manual

RILEVATORE DI VENE PROFESSIONALE QV-500
QV-500 PROFESSIONAL VEIN FINDER

QV-500 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

Overview

1.1 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  xperience. 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  alpation 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.
1.2 Product Description
Using the Vein FInder allows you to significantly speed up the puncture and cannulation procedure. Vein finder operates by using infrared light to detect only 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, blemishes, scars, tattoos), hair, scarring or other highly contoured skin surface, and adipose (fatty) tissue. Remember not to point the light source directly into the eyes of the patient or professional
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.|
1.3 Use and Operation
Hold the device from 25 to 35 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.

Safety

WARNING:

• 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
• All devices, medical and non-medical, operating on the basis of high frequency can cause interference in the operation of the device. Use Finder away from such devices
• If the available electric network is not equipped with an earthing system, use only the battery power supply.
• Do not allow the patient’s body to come into contact with the device
• This Finder does not show the location of the arteries. It only visualizes the veins.
• A medical device is not intended for diagnosis or treatment
• The product is not waterproof, if you suspect that a liquid has entered the device, stop using it.
• Before each use, check all components and accessories of the device, including the power cord, power adapter. In the event of any damage, please discontinue use of the product and contact QUALMEDI after-sales service or your local supplier.
• Only use the dedicated accessories supplied by QUALMEDI.
• The battery of this device is replaceable. If you do not plan to use the device for an extended period of time, charge the battery to 100% and remove it from the device.
• The device and accesorry should be operated, stored and transported in accordance with the provisions of the operating manual.
• The device must not be used in a flammable or explosive environment or in the vicinity of flammable or explosive materials
• Dispose of the device, accessories and battery according to local regulations.
• Do not:
  upgrade software;
  open shell of device; replace battery with different model try to repair the device.

CAUTION:

• The device or change its settings.
• The device cannot be used only on the mains power supply (without the battery installed)
• If you have any comments regarding the device, please inform your local dealer or QUALMEDI after-sales support.

Product Specifications

Output: 5V, 2A
Battery| Built-in lithium battery: 3.6V, 3000mAh Battery model: 18650-319
Continuous operation duration of the lithium battery: not shorter than 2.5 hours
Time required for fully charging an exhausted lithium battery: not longer than 3 hours (the device is powered off during the charge)
Charge mode of the lithium battery: The battery can be charged using a power adapter when AC input is avai- lable.
Display Mode| Projection mode
Light Source Type| Near-infrared light
Infrared Wavelength| 850nm dual light sources
Optimal Focus Position| 250mm±50mm
Depth of Field of Imaging| 7-9mm
Infrared Radiation Energy| ≤0.6mW/m
Operating Conditions| Temperature: 5°C~40°C
Humidity: 20%~90% RH, non-condensing Pressure altitude: 70~106.0kPa
Storage and Shipping Conditions| Temperature: -20°C~+55°C
Humidity: 10%~95% RH, non-condensing Pressure altitude: 61.7~107.4kPa
Service Life| 5 years
Classification| 1. Class I/Internally powered equipment;
2. IPX0;
3. Not sterilized;
4. Not category AP/APG equipment;
5. Mode of operation: continuous
Date of Manufacture| See the product label.
Main Safety Standards| IEC 60601-1:2012
Medical Electrical Equipment, Part 1: General Requirements for basic safety and essential performance IEC 60601-1-2:2014
Medical Electrical Equipment – Part1-2: General requirements for basic safety and essential performance-Col- lateral standard: Electromagnetic compatibility-Requirements and tests

Installation Description

The machine needs to be checked weekly to see if it needs to be recalibrated

Operating Instructions

In the sport mode, a picture is collected and projected in every frame. In the enhance mode, many pictures are collected and intermittent veins in the picture are connected into a complete vein through image processing, so the display frame rate will decrease
Operating Instructions – Functionality of Buttons

when there is no operation for 10 mins. As for manual setting, Short press make machine enter low energy consump- tion mode immediately. Long press for 3 seconds makes machine enter never sleep mode, which be shown no ‘T’ projected in top left corner.
Mode| MODE| Enhanced mode to improve vessel clarity. Sport mode for the quick response. Mode indicate on the top of projection image.
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Brightness| | 7 Levels of brightness. Adjust projection image to the most comfortable level.
Size| | 5 Sizes Available. Suitable for adults, children and newborns.
Inverse| | Inverts the dark and light projection areas such that veins can be depicted by either light or dark. Changing the inverse setting may improve vein visibility.
Color| | 10 Colors Available. Suitable for different skin colors or operating environments.
Indicator Light| | Blue: Working; Green: Fully charged; Red: Charging Red Blinking: Insufficient battery power. (Less than 10% battery capacity)

Common Faults

The device is connected to the power supply, but it is not turn on
Possible cause:
a. The connection to the power supply is defective or the power supply is damaged and there is no voltage in it
b. As a result of using a non-dedicated power supply, the motherboard was damaged
Check method:
a. Check the correctness of the connection between the device and the power supply by verifying that the information diode is permanently illuminated
b. Try to start the device with the power supply disconnected from the device (Battery takes over all power)
The image from the projector is out of focus or there are artifacts in the image
The optical lens is grubby.
Clean optics as mentioned in chapter 7.2
The wire finder does not work when power is supplied only from the battery
Storing the battery in humid conditions may damage it or the battery is discharged
Connect the vein finder to the power supply to charge the device battery. The diode turns off when the battery is fully charged. If the device still cannot be turned on, please contact the QUALIMED technical department.
The battery discharges faster than expected in continuous operation.
The battery charge is too low or far from full. Battery life also diminishes over time due to physical constraints.
Check the battery by connecting it to charging. The flashing diode informs about the ongoing charging process, and when it goes out completely, the process is finished. As  the charge and discharge cycles increase, the continuous operating life of the battery naturally slowly decreases. When this time is no longer acceptable, please contact the  QUALIMED technical department. (How to replcae the battery: Open the back cover of the battery, take out the original battery, and put the new battery into the battery compartment. )
The device does not respond to user commands or freezes
The temperature of the device has risen to higher values through a long time of continuous operation
Turn off the device and wait a long time until the internal temperature returns to normal

Cleaning and Disinfection

7.1 Preparations

1. To clean and disinfect, turn off the vein finder and disconnect it from the power supply.
2. For the sake of your own health, all operations should be performed with rubber gloves and a face mask.
3. Only the external surfaces of the device should be cleaned and disinfected. It is forbidden to disassemble the device on your own. If necessary, please contact the service.
4. Follow the instructions!

7.2 Cleaning
Do not put the device in detergents.
Do not allow the detergents to come into contact with the electronics of the device.
Do not use any harsh detergents such as, for example: acetone, glass detergent, halogenated or petroleum based solvents.
Only manual cleaning is advisable, it is forbidden to use automatic cleaning mode.

1. Wipe the outer parts of the device with squeezed gauze, previously dipped in a detergent solution with a neutral or slightly alkaline pH.
2. Wipe the device until it is completely clean.
3. To clean the optics, use a piece of optical lens cleaning paper with a few drops of ethyl alcohol. Do it only one way.
4. Do not forget to clean the end parts of the device.
5. After cleaning, use dry gauze to wipe off any remaining cleaning solution.

7.3 Disinfection

• Do not put the device in disinfectants.
• Do not allow the disinfectant to come into contact with the electronics of the device.
• Do not autoclave the device.
• The only permissible disinfection method for the device is manual disinfection.

1. Before starting the disinfection process, clean the device in accordance with section 7.2.
2. The device should be wiped with medical gauze, then dipped in a disinfectant. Agents with high or medium disinfection efficiency are allowed.
3. It is recommended to wipe the entire exterior of the device. The instructions for use of the disinfectant, in particular – the contact time of the disinfectant with the device, must be followed.
4. To clean the optics, use a piece of optical lens cleaning paper with a few drops of disinfectant. This should be done gently.
5. Do not forget to disinfect the end parts of the device.
6. Finally, wipe the device with a soft medical gauze, dipped and then squeezed out of clean water.

Do not use a dryer or items similar to drying the vein finder.
The device may only be connected to the power supply after it is completely dry.
When cleaning and disinfection is complete, place the vein detector in a cool, ventilated place out of direct sunlight to dry it.
If the device is not to be used immediately after it is dry, it should be stored in its original packaging.

Maintenance

Regular maintenance and inspection of the device is essential to maximize its lifetime and ensure safety during use.
8.1 Appearance Check
Check the external condition of the device for cracks or other damage.
Check whether the buttons are functioning properly and whether it is comfortable to click them.
The appearance and keys of the machine should be checked once a week to see if there is any damage

8.2 Power Adapter and Power Cable Check
Visually assess the external technical condition of the cable and the power supply. Please contact your distributor for repair if any damage to the surface or contact problems  of the plug and socket are found.
Contact the distributor for repair if it is not possible to start the device or if the indicator does not show the correct operation of the AC /  DC adapter.
Power adapters and data cables should be checked monthly
8.3 Electrical Safety Test
The safety check complies with IEC60601-1. Dielectric strength test, ground impedance test and leakage current test should be performed.
It is forbidden to store the device in excessively hot or humid places.
Do not store the device near dust and gases that can cause corrosion. Avoid vibrations.
Avoid places with high sun exposure and ultraviolet light to prevent the possibility of color fading.
The device can be transported in a common vehicle, but protection against excessive vibrations and mechanical damage should be ensured. It must be protected against rain, snow and other weather conditions. The contractual transport requirements must be adhered to.
Consult your distributor for recycling your decommissioned device. Alternatively, disposal of the device and batteries should be carried out in accordance with national regulations.

Packing List

Guidance and manufacturer’s declaration – electromagnetic emissions

The QV-500 mu is intended for use in the electromagnetic environment specified below. The customer or the user of the QV-500 should ensure that it is used in such an environment.
Emissions test| Compliance| Electromagnetic environment –guidance
RF emissionsCISPR 11| Group 1| This device uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likelyto cause any interference to nearby electronic equipment.
RF emissions CISPR 11| Class A
Harmonic emissions IEC 61000-3-2| Class A| This device is suitable for use inprofessional healthcare facility environment.
---|---|---
Voltage fluctuations /flicker emissions
IEC 61000-3-3| Complies
Guidance and manufacturer’s declaration – electromagnetic immunity

The QV-500 mu is intended for use in the electromagnetic environment specified below. The customer or the user of the QV-500 mu should ensure that it is used in such an environment.
Immunity test| IEC 60601 test level| Compliance level| Electromagnetic environment – guidance

Electrostatic discharge (ESD) IEC 61000-4-2

| +/− 8 kV contact

+/− 15 kV air

| +/− 8 kV contact

+/− 15 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 %.
At 8 kV and 15 kV air discharge a temporaly degradation of performance can occur resulting in a loss of function . Within several minutes performance is restored. Basic safety is guaranteed. The user is advised to contact Diagnoptics techni- cal support.
Electrical fast transient/ burst IEC 61000-4-4| +/− 2 kV for power supply lines| +/− 2 kV for power supply lines| Mains power quality should be that of a typical hospital en- vironment.
Temporarly degradation of performance can occur resulting in a loss of function. Basic safety is guaranteed. The user is advised to contact Diagnoptics technical support.
Surge IEC 61000-4-5| +/−1 kV line(s) to line(s)| +/−1 kV line(s) to line(s)| Mains power quality should be that of a typical hospital environ- ment.
Voltage dips, short interruptions and voltage variations to power supply input lines

IEC 61000-4-11

| 0% UT for 0,5 cycle at 0°, 45°, 90°, 135°, 180°, 225°, 270° and  315° 0% UT for 1 cycle 70% UT for 25/30 cycles 0% UT for 250/300 cycles| 0% UT for 0,5 cycle at 0°, 45°, 90°, 135°, 180°, 225°, 270°  and 315° 0% UT for 1 cycle 70% UT for 25/30 cycles 0% UT for 250/300 cycles| Mains power quality should be that of a typical hospital en- vironment. If the user of the vein Finder requires continued operation during mains power interruptions, it is recommended that the vein finder is powered from an  uninterruptible power supply or a battery.
UT is the AC. mains voltage prior to application of the test level.
Power frequency (50/60 Hz) magnetic field
IEC 61000-4-8| 30 A/m| 30 A/m| Power frequency magnetic fields
should be at levels characteristic of a typical location in a typical
hospital environment.
Conducted RF IEC 61000-4-6| 3 V0,15MHz to 80 MHz 6 V in  ISM bands between 0,15 MHz &  80 MHz 80 % AM at 1 kHz| 3 V 0,15MHz to 80 MHz 6 V in  ISM bands between 0,15 MHz & 80 MHz 80 % AM at 1 kHz| Portable and mobile RF com- munications equipment should be used no closer than the re- commended sepa- ration distance calculated from the equation applicable to the frequency of the transmitter to any part of the vein finder, including cables,.
Immunity to RF wireless communication equipment

The QV-500 mu is intended for use in the electromagnetic environment specified below.
The customer or the user of the QV-500 mu should ensure that it is used in such an environment.
Test frequency (MHz)| Band (MHz)| Service| Modulation| Maximum power (W)| Distance(m)| Immunitytest level (V/m)
385| 380 – 390| TETRA 400| Pulse modulation 18 Hz| 1,8| 0,3| 27
450| 430 – 470| GMRS 460,
FRS 460| FM ± 5 kHz deviation 1 kHz sine| 2| 0,3| 28
At this frequency degradation of performance can occur resulting in a loss of function and a measu-rement setup error. Basic safety is guaranteed.
The user is advised to contact Diagnoptics technical support.
710| 430 – 470| LTE Band 13,17| Pulse modulation 217 Hz| 0,2| 0,3| 9
745
780
810| 704 – 787| GSM 800/900,TETRA 800,
iDEN 820,
CDMA 850,
LTE Band 5| Pulse modulation 18 Hz| 2| 0,3| 28
---|---|---|---|---|---|---
870
930
1720| 800 – 960| GSM 1800;

CDMA 1900;
GSM 1900;DECT;
LTE Band 1, 3,
4, 25; UMTS

| Pulse modulation 217 Hz| 2| 0,3| 28
1845
1970
2450| 2400 – 2570| Bluetooth,WLAN,
802.11 b/g/n,
RFID 2450,
LTE Band 7| Pulse modulation 217 Hz| 2| 0,3| 28
5240| 5100 – 5800| WLAN 802.11
a/n| Pulse modulation 217 Hz| 0,2| 0,3| 9
5500
5785
The frequencies and services listed are representative examples that are based on RF communications equipment in use at the time of publication of IEC 61000-4-3. The test specification does not attempt to cover every frequency and service used in every country.

Symbols

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 specific recycling point for electric and electronic equipment

QV-500 (GIMA 23456)
Qualmedi Technology Co.
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

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