VivaChek HH-XIII-T - User Manual

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PRINCIPLE AND INTENDED USE

The VivaChek™ Lancing Device is used with VivaChek™ sterile lancets or any other compatible

disposable sterile lancets to draw capillary blood from the fingertip, palm (at base of the thumb) or

forearm, for blood glucose testing or other testing utilizing small amounts of blood.

INSTRUCTIONS FOR USE

Before testing, choose a clean, dry work surface. Familiarize yourself with the procedure and make

sure you have all the items needed to obtain a drop of blood.

Important: Prior to testing, wipe the test site with an alcohol swab or soapy water. Use warm water to

increase blood flow if necessary. Then dry your hands and the test site thoroughly. Make sure there is

no alcohol, soap or lotion on the test site.

SAMPLING FROM THE FINGERTIP

For fingertip sampling, adjust the depth penetration to reduce the discomfort. You do not need the

clear cap for fingertip sampling.

1. Unscrew the lancing device cover from the

body of the lancing device. Insert a sterile

lancet into the lancing device and push it

until the lancet comes to a complete stop

in the lancing device.

2. Hold the lancet firmly in the lancing device

and twist the safety tab of the lancet until it

loosens, then pull the safety tab off the

lancet. Save the safety tab for lancet

disposal.

3. Carefully screw the cover back onto the

lancing device. Avoid contact with the

exposed needle. Make sure the cover is

fully sealed on the lancing device.

4. Adjust the puncture depth by rotating the

lancing device cover. There are a total of 5

puncture depth settings. To reduce the discomfort, use the lowest setting that still produces an

adequate drop of blood.

Adjustment:

1 for delicate skin

2 and 3 for normal skin

4 and 5 for calloused or thick skin

Note: Greater pressure of the lancing device against the finger will also increase the puncture depth.

5. Pull the cocking barrel back to set the lancing device. You may hear a

click to indicate the lancing device is now loaded and ready for obtaining

a drop of blood.

6. Prior to testing, wipe your hand with an alcohol swab or wash your

hands with soap. Use warm water to increase

blood flow in your fingers if necessary. Then

dry your hands thoroughly. Massage the hand

from the wrist up to the fingertip a few times to

encourage blood flow.

7. Hold the lancing device against the side of the

finger to be lanced with the cover resting on the finger. Push the release button to prick your

fingertip. You should hear a click as the lancing

device activates. Gently massage from the

base of the finger to the tip of the finger to

obtain the required blood volume. Avoid

smearing the drop of blood.

Note: For the greatest reduction in pain, lance on the sides of the fingertips. Rotation of sites is

recommended. Repeated punctures in the same spot can make your fingers sore and callused.

8. Unscrew the lancing device cover. Place the safety tab of the lancet on a hard surface and

carefully insert the lancet needle into the safety tab.

9. Press the release button to make sure

that the lancet is in the extended position.

Slide the ejection button forward to

discard the used lancet to a container for

sharp objects. Place the lancing device

cover back on the lancing device.

Warning:

The VivaChek™ lancing device is designed for self testing by a single

patient. It must not be used on more than one person due to the risk of

infection.

Use a new VivaChek™ lancet each time you test because it is no

longer sterile after use.

Always dispose of the used lance properly to prevent injury or contamination to others.

SAMPLING FROM FOREARM OR PALM (AT THE BASE OF THE THUMB)

The forearm and palm areas have less nerve endings than the fingertip. You may find that obtaining

blood from these sites is less painful than from the fingertip. The procedure for forearm and palm

sampling is different. You need the clear cap to draw blood from these sites. The clear cap is not

adjustable for puncture depth.

Follow Step 1 and 2 to insert the lancet and load the lancing device.

3. Screw the clear cap onto the lancing

device.

Note: To bring fresh blood to the surface of

the puncture site, massage the puncture site

vigorously for a few seconds until you feel it

getting warm

4. Choose a puncture site on the forearm or palm. Select a soft and fleshy area of the forearm and

palm that is clean and dry, away from bone, and free of visible veins

and hair.

5. Place the lancing device against the puncture site. Press and hold

the clear cap against the puncture site for a few seconds. Press the

release button of the lancing device, but do not immediately lift the

lancing device from the puncture site. Continue to hold the lancing

device against the puncture site until you can confirm a sufficient

blood sample has formed.

CARE OF THE LANCING DEVICE

Clean the lancing device using a soft cloth with mild soap and warm water as required. Use 70%

Isopropyl Alcohol to disinfect the lancing device. Carefully dry the lancing device. Do not immerse the

lancing device in liquid.

PRECAUTIONS

 Do not use the lancet if the safety tab is missing or loose when you take the lancet out of the bag.

 Do not use the lancet if the needle is bent.

 Use caution whenever the lancet needle is exposed.

 Never share lancets or the lancing device with other people.

 In order to reduce the risk of infection from prior use of the instrument, always use a new, sterile

lancet. Do not reuse lancets.

 Avoid getting the lancing device or lancets dirty with hand lotion, oils, dirt or debris.

LIMITED WARRANTY

If the lancing device does not work for any reason other than obvious abuse in the first 5 years after

purchase, we will replace it with a new or equivalent lancing device free of charge. Please contact

your local dealer for replacement.

INDEX OF SYMBOLS

Consult instructions for

use

Lot number REF

Tuotenume

Catalog number

Manufacturer

Authorized Representative

VivaChek™ is a trademark of VivaChek Biotech (Hangzhou) Co., Ltd. Number: 1201021303

MODEL HH-XIII-T REF VGD01-001

English

Lancin

device

acka

e insert

Need help?

Do you have a question about the VivaChek HH-XIII-T and is the answer not in the manual?

The VivaChek™ Lancing Device (Model HH-XIII-T, REF VGD01-001) is a medical device designed for self-testing by a single patient to draw capillary blood. It is intended for use with VivaChek™ sterile lancets or other compatible disposable sterile lancets to obtain small amounts of blood for glucose testing or other diagnostic purposes. Blood can be sampled from the fingertip, palm (at the base of the thumb), or forearm.

Function Description:

The lancing device operates by precisely puncturing the skin with a sterile lancet to obtain a blood sample. It features a cocking barrel to arm the device, a release button to activate the lancet, and an ejection button for safe disposal of used lancets. The device includes a lancing device cover and puncture depth settings, allowing users to customize the penetration depth based on their skin type and desired comfort level. For fingertip sampling, the device uses its standard cover with adjustable depth settings. For forearm or palm sampling, a clear cap is used, which is not adjustable for puncture depth but helps in obtaining a sufficient blood sample from these alternative sites.

Important Technical Specifications:

The device offers 5 puncture depth settings:

Setting 1: For delicate skin.
Settings 2 and 3: For normal skin.
Settings 4 and 5: For calloused or thick skin. The puncture depth is also influenced by the pressure applied to the lancing device against the skin.

Usage Features:

General Preparation:

Before testing, users should choose a clean, dry work surface and gather all necessary items. The test site must be wiped with an alcohol swab or soapy water and then thoroughly dried. Warm water can be used to increase blood flow if necessary. It is crucial to ensure no alcohol, soap, or lotion remains on the test site.

Fingertip Sampling Procedure:

Lancet Insertion: Unscrew the lancing device cover and insert a sterile lancet until it stops.
Safety Tab Removal: Hold the lancet firmly, twist the safety tab until loose, then pull it off. The safety tab should be saved for lancet disposal.
Cover Reattachment: Carefully screw the cover back onto the lancing device, avoiding contact with the exposed needle. Ensure the cover is fully sealed.
Depth Adjustment: Rotate the lancing device cover to select one of the 5 puncture depth settings. For reduced discomfort, the lowest setting that still yields an adequate blood drop is recommended.
Cocking the Device: Pull the cocking barrel back until a click indicates the device is loaded.
Site Preparation: Clean hands with an alcohol swab or soap and warm water to increase blood flow. Dry hands thoroughly. Massage the hand from the wrist to the fingertip a few times.
Puncture: Hold the lancing device against the side of the finger (recommended for reduced pain and to avoid calluses). Press the release button to prick the fingertip. A click will be heard. Gently massage from the base of the finger to the tip to obtain the required blood volume, avoiding smearing the drop.
Lancet Disposal: Unscrew the lancing device cover. Place the safety tab on a hard surface and carefully insert the used lancet needle into the safety tab. Press the release button to ensure the lancet is in the extended position. Slide the ejection button forward to discard the lancet into a sharps container. Replace the lancing device cover.

Forearm or Palm Sampling Procedure:

This method is less painful due to fewer nerve endings. It requires the clear cap, which is not adjustable for puncture depth.

Lancet Insertion and Loading: Follow steps 1 and 2 of the fingertip sampling procedure to insert and load the lancet.
Clear Cap Attachment: Screw the clear cap onto the lancing device.
Site Preparation: Massage the puncture site vigorously for a few seconds until it feels warm to bring fresh blood to the surface. Choose a soft, fleshy, clean, and dry area away from bone, veins, and hair.
Puncture: Place the lancing device against the puncture site. Press and hold the clear cap against the skin for a few seconds. Press the release button, but do not immediately lift the device. Continue holding it against the skin until a sufficient blood sample has formed.

Maintenance Features:

The lancing device should be cleaned with a soft cloth using mild soap and warm water as needed. For disinfection, use 70% Isopropyl Alcohol. The device must be carefully dried and not immersed in liquid.

Precautions:

Do not use the lancet if the safety tab is missing or loose, or if the needle is bent.
Exercise caution when the lancet needle is exposed.
Never share lancets or the lancing device with other people.
Always use a new, sterile lancet to reduce infection risk. Do not reuse lancets.
Avoid contaminating the device or lancets with hand lotion, oils, dirt, or debris.

Limited Warranty:

The VivaChek™ lancing device comes with a 5-year warranty. If it malfunctions due to reasons other than obvious abuse, it will be replaced with a new or equivalent lancing device free of charge. Users should contact their local dealer for replacement.

VivaChek HH-XIII-T Specifications

General

Brand	VivaChek
Model	HH-XIII-T
Category	Blood Glucose Meter
Language	English

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