08/24/2006

Alba Health Supplies Co., Ltd.

Flow Controll Sets

WHAT IS Flow Controll Sets?
GENERAL DESCRIPTION OF FLOWMETER

The apparatus that is used to determine how much milliliter will pass through the tubing per hour in order to give the correct amount of I.V. solution that the patient needs in certain amount of time.

The product mainliy used for drop adjusting of medical or solution in clinic to patient. It shall be used cooperate with order infusion devices.

Teh devices are only used by skilled personnel (doctors and nurses ). Moreover the User Instruction and labels include additional advices for use ana also warnings
PARTS OF PRODUCT

·Female luer protector cap
·Female Luer
·Flow adjusting upper part
·Precise flow rate control
·Conta
·Flow adjusting below part
·infection port
·Luer lock connector
·Pipe
·Male luer
·Female luer protector cap
·Pipe

STATEMENT REGARDING LIFE-SPAN

The labels indicates dates of production and expiration. If the package is damaged, it cano not be guaranteed that it will be germ-free. Aging of plastics parts can be observed after the expiration date.

We guarente 5 years of shelf life with the usage of “ Steriking Tyvek Heat sealable Reels” and 3 years of shelf-life with the usage of “Steriking see-through reels”

CLASSIFICATION

Rule 2 ( 93/42/EC Appendix IX )

All non-invasive devices intended for channeling or storing blood, body liquids or tissues, liquids or gases for the purpose of eventual infusion, administration or introduction into the body are in Class Iia:

·If they may be connected to an active medical device in Class Iia or higher class,
·If they are intended for use for storing or channelling blood or other body liquids or for storing organs, parts of organs or body tissues,

In all other cases they are in Class I

CONFORMITY ASSESSMENT PROCEDURE

In order to affix CE marking on the flowmeter, we applied Annex II (full quality assurance ) except point 4 in addition to EC declaration. (93/42/EC)

AUTHORISED REPRESENTATIVE
MEDICAL DEVICE SAFETY SERVICE GMBH (MDSS)