Instructions For Use - IGL Box Organ Instrucciones De Uso

INSTRUCTION FOR USE
EN
IGLBOX ORGAN TRANSPORTER
Kidney, heart, pancreas
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 Kidney, heart, pancreas contains:
• IGLBox Transport bag: Transport bag: non-sterile / reusable.
• IGLBox Organ Container: Biocompatible rigid container with two bags: sterile / single use only.
• IGLBox Insulated Box: Insulated Box: non-sterile / single use only.
• IGLBox Gel Pack (x4): Ice packs: non-sterile / reusable.
IGLBox
Transport Bag
(IGLBox-TB)
DESCRIPTION
The IGLBox Transport Bag is a washable and resistant polyamide fabric shell. It is intended
to house and protect the organ placed into the IGLBox Organ Container maintained at
a temperature between +2°C and +8°C by IGLBox Insulated Box 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.
The IGLBox Organ Container (biocompatible polypropylene) is composed of one
container with one lid which includes four locking lid clips and two (2) sterile bags
equipped with adhesive type closure.
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 four (4) IGLBox Gel Packs and IGLBox Organ Transport bag must be available prior to using the IGLBox Organ Container.
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. Unpack IGLBox Organ Container using the easy opening (press "open here" area and edges of the packaging to unpack).
Open the peelable zone of the bag to aseptically handle the container, lid and two (2) sterile bags.
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IGLBox IGLBox IGLBox
Insulated Box Organ Container Gel pack
(IGLBox-IB) (IGLBox-OC) (IGLBox-GP)
Label and documentation
location
Samples
compartments
Strap
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
USE
Refer to applicable protocols for preconditioning of organs.
1. Organ conditioning in the Sterile Operating Room
• Place the preconditioned organ into the Organ Container. Organ must be flushed before being placed
in the container in accordance with cold storage solution instructions.
• Fill the container with cold storage solution until total immersion of the organ.
• Place the lid and close the four (4) locking clips.
• Place the first sterile bag on a flat surface, opening upwards, and insert the container holding the organ.
• Remove excess air from the bag and close by removing the protection of the adhesive zone and lining up the cross pattern.
• Place the first sterile bag in the second bag by repeating the same actions.
2. Placing Organ container in the transport bag
• Place Insulated Box into Transport bag.
• Place 4 (four) pre-conditioned Gel Packs in the Insulated Box side inserts.
• Place the double overwrapped IGLBox Organ Container into the Insulated Box.
• Close the Insulated Box and close/zip the Transport Bag. The IGLBox Organ Transporter maintains the organ storage temperature
between 2°C and 8°C through 48 hours.
3. Organ deconditioning
• Open Transport Bag and remove Insulated Box using handles.
• Open Insulated Box and remove Organ Container and Gel Packs.
• Open the sterile bags using easy opening.
• Remove the IGLBox Organ Container using both hands.
• Place the IGLBox Organ Container on a flat surface. Remove the lid by unlocking the four (4) clips.
• Collect the organ and conduct flushing in accordance to applicable protocols.
Handles
CLEANING
• Clean external and internal surfaces of Transport Bag using dry clean wipes to remove visible dust or soil. Discard the wipes after cleaning.
• To clean the contaminated areas apply cleaning spray (such as Hydrogen Peroxide Cleaning Spray) following spray manufacturer's instructions for use.
Secured
• Use clean scrub brush as needed to remove hard visible residues.
attachment
• Perform low level disinfection by using disinfecting wipes (such as Clorox Hydrogen Peroxide Disinfectant Wipes) for at least 30 seconds.
Refer to wipes manufacturer's instructions for use before application.
• Dry surfaces by wiping with a clean lint-free soft dry cloth.
Insulated
compartiment
WARNING
for organ
If the outside temperature is higher than 25°C, IGLBox Organ Transporter maintains the organ storage temperature between 2°C and 8°C through 35 hours.
Do not open the device during transport. Keep the device upright during transport.
IGLBox Transport Bag and Gel packs must be visually inspected before and after each use, cleaned in case of soiling and discarded in case of visual damage or pitting.
The IGLBox Insulated Box and IGLBox Organ Container are single use. Discard items in compliance with protocols for contaminated wastes.
Caution: Federal law restricts this device to sale by or on the order of a physician.
CONTRAINDICATIONS AND ADVERSE REACTIONS
Do not use this product for patients whose weight is less than 3.5 kg.
Check expiration date before use
Attention, see instruction for use
Single use only: biocontamination
risk if reuse
Sterile device. Ethylene oxide Sterilization
Institut Georges Lopez
Keep dry
Keep away from the sun
Do not use
if damaged
Do not re-sterilize
Parc Tertiaire du Bois Dieu I RN6 I 1, allée des Chevreuils
69380 Lissieu I France
Tel. +33 (0)4 37 64 63 32 I Fax +33 (0)4 37 64 60 09
www.groupe-igl.com I welcome @ groupe-igl.com
2004
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