Instructions For Use; Intended Use - IGL Box Organ Instrucciones De Uso

INSTRUCTION FOR USE
EN

INTENDED USE

The IGLBox Organ Transporter is intended to be used for the static hypothermic preservation of organs (kidney, pancreas, heart and liver) during transportation for eventual
transplantation into a recipient, using cold storage solution indicated for use with these organs.
IGLBox Organ Transporter has 2 configurations: a configuration for kidney, heart, pancreas and a configuration for liver.
IGLBox Organ Transporter configuration for Liver contains:
• IGLBox Transport bag: Transport bag: non-sterile / reusable.
• IGLBox Insulated Box XL: Insulated Box: non-sterile / single use only.
• IGLBox Gel Pack (x2): Ice packs: non-sterile / reusable.
DESCRIPTION
The IGLBox Transport Bag is a washable and resistant polyamide fabric shell. It is intended
to house and protect the organ placed into three biocompatible, sterile and watertight
bags (not supplied) maintained at a temperature between +2°C and +8°C by IGLBox
Insulated Box XL and IGLBox Gel Packs.
A strap and two handles allow shoulder or hand carrying. 2 D-rings are also available on
the shell to provide a secured attachment mean during transportation.
The upper compartment is able to house documentation and labels. The second
compartment allows storage of biological samples tubes. The internal compartment of
the bag is suitable for storing donor documents. The lower compartment is designed to
accommodate the Insulated Box XL.
TRANSPORT BAG INSPECTION BEFORE USE
Inspect Transport Bag before each reuse. The Transport Bag is to be discarded and replaced, in case any of the following acceptance criteria is not meet. Transport Bag which fails
the inspection must be discarded per hospital protocol for non-infectious biological waste. In case of dirt or soiling before use, refer to the cleaning instructions.
Items to inspect
Film clear inserts for document
Zippers
Bag outside/inside
Hand straps
D-rings for shoulder strap/for secured attachment
Should strap
Labeling information
PREPARATION
The IGLBox Insulated Box along with two (2) IGLBox Gel Packs and IGLBox Organ Transport bag must be available prior to conditioning the organ in the three bags. These bags must be
sterile, biocompatible and watertight. Gel Packs must be stored at -20°C± 2°C for at least 24 hours to ensure optimal thermal performance. Before use, Gel Packs must be exposed to
ambient temperature for 15 minutes prior to placing into the inserts of the Insulated Box for transport.
IFU.IGLBox-XL Rev 02 (2017-11-09)
4
IGLBOX ORGAN TRANSPORTER
Liver
IGLBox IGLBox
Transport Bag Insulated Box XL
(IGLBox-TB) (IGLBox-IBXL)
Acceptance Criteria
• No discoloration
• No tears, holes
• Documents inserted must remained secured and legible
• Not defective
• Zippers must ensure a complete and secure closing of compartments
• No abnormal wear pattern, excessive wear
• No abrasive evidence
• No cuts or frayed fabric
• No discoloration
• No tears, holes
• No frayed or insecure seam
• No acid / caustic / thermal burn
• No imbedded particles
• Handles must remain completely attached to the bag when applying a manual pulling force
• D-rings must remain completely attached to the bag when applying a manual pulling force
• No broken or worn stitches
• No knots
• No tears, holes or fraying
• No imbedded particles
• Not removed, altered or obscured
• Labeling information must be legible
IGLBox
Gel Pack
(IGLBox-GP)
Label and documentation
location
Samples
compartments
Strap
Handles
Secured
attachment
Insulated
compartiment
for organ