GIMA M23919 Lancing Device Installation Guide

: June 15, 2024
: GIMA

Table of Contents

M23919 Lancing Device
GIMA WARRANTY TERMS
Documents / Resources
- Read User Manual Online (PDF format)
- Download This Manual (PDF format)

PROFESSIONAL MEDICAL PRODUCTS

M23919 Lancing Device

AUTO LANCET DEVICE

The name of the device :
Lancing Device

Principle and intended Use:
Assisting the lancet for peripheral blood sampling from the fingertip or the paw for blood glucose testing or other testing utilising a small amount of blood, it is the non-invasive device and does not come into contact with blood, it only makes a brief contact with the skin surface for a few seconds. The lancing device is non-sterile.

Caution:

The lancing device is for single patient use. Do not share it with anyone including other family members! Do not use on multiple patients!
Do not reuse lancet, always use a new, sterile lancet for testing.
Use caution whenever the lancet needle is exposed, especially when remov- ing the used lancet from the device and when disposing the used lancet.
A notice to the user and/or patient that any serious incident that has oc- curred 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.

Shelf-life:
Valid period of product is 5 years

Use Instructions:

The device can be reuse. Keep the Lancing Device clean, Disinfection of lancing Device Cap with alcohol pad or cotton balls before use.
Twist off the Lancing Device Cap.
Insert a new sterile lancet into the Lancet Holde. Push down firmly until it is fully seated.
Twist off the Lancet Protective Cap and save the Cap for later use. Replace the Lancing Device Cap.
Set the lancing level by twisting the Adjustable Tip until the number lines up with the Arrow.
To select the best depth: 1-2 for soft or thin skin 3 for average skin 4-5 for thick or calloused skin
Slowly pull back the Cocking Control. You will hear a click, indicating that the Lancing Device is now loaded and ready to use.
Hold the Lancing Device firmly against the side-tip of the finger. Press the Release Button. Set the Lancing Device aside and proceed with your blood glucose test according to your blood glucose mete’s directions.
After use, twist off the Lancing Device Cap. Push the exposed tip of the lancet into its Protective Cap.
Slide the Lancet Ejector forward and disposing the used lancet in an approved container. Discard the used lancet according to your country’s safety regulations. Replace the Lancet Device Cap.

The Performance characteristics of the devices:
The product consists of the main body, Popup mechanism and adjustment set.

Transportation and Storage:
Common conveyance are available in the transport, please prevent heavy Pres-sure,rainwater and snow and collision; the packed products shall be stored ina well ventilated room free of any poisonous, harmful and corrosive substances.

GIMA WARRANTY TERMS

The Gima 12-month standard B2B warranty applies.

| Authorized representative in the European community
---|---
| Medical Device compliant with Regulation (EU) 2017/745
| Date of manufacture
| Manufacturer
| Expiration date
| Product code
| Lot number
| Temperature limit
| Humidity limit
| Keep in a cool, dry place
| Consult instructions for use
| Caution: read instructions (warnings) carefully
| Medical Device

E (23919)
Shandong Lianfa Medical Plastic Products Co.,Ltd
Address: No.1 Shuangshan Sanjian Road, 250200 Zhangqiu City, Jinan Shandong, PEOPLE’S REPUBLIC OF CHINA
Made in China
Linkfar Healthcare GmbH
NiederrheinstraBe 71, 40474 Dusseldorf, Germany

Imported by : Gima S.p.A.
Via Marconi, 1 – 20060 Gessate (MI) Italy
gima@gimaitaly.com – export@gimaitaly.com
www.gimaitaly.com

M23919-M-Rev.0-10.21