IGL Box Organ Instrucciones De Uso página 5

USE
Refer to applicable protocols for preconditioning of organs.
1. Organ conditioning in the Sterile Operating Room
• Organ must be flushed before being placed in a first sterile bag (not supplied) in accordance with cold storage solution instructions.
• Fill the bag with cold storage solution until total immersion of the organ.
• Place the second sterile bag on a flat surface, opening upwards, and insert the first sterile bag containing the organ.
• Remove excess air from the bag and close.
• Place the second sterile bag in the third bag by repeating the same actions.
2. Placing Organ container in the transport bag
• Place Insulated Box into Transport bag.
• Place 2 (two) pre-conditioned Gel Packs in the Insulated Box XL side inserts.
• Place the triple overwrapped organ into the Insulated Box XL.
• Close the Insulated Box XL and close/zip the Transport Bag.
• The IGLBox Organ Transporter (liver) maintains the organ storage temperature.
between 2°C and 8°C through 17 hours.
3. Organ deconditioning
• Open Transport Bag and remove Insulated Box XL using handles.
• Open Insulated Box and remove the conditioned organ and Gel Packs.
• Open the sterile bags.
• Collect the organ and conduct flushing in accordance to applicable protocols.
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.
• Use clean scrub brush as needed to remove hard visible residues.
• 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.
WARNING
If the outside temperature is higher than 25°C, IGLBox Organ Transporter (liver) maintains the organ storage temperature between 2°C and 8°C through 14 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 XL is 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
There are no known contraindications when used as directed. There is no known adverse reaction linked to IGLBox Organ Container when used as directed.
Check expiration date before use
Attention, see instruction for use
Single use only : biocontamination
risk if reuse
Institut Georges Lopez
Keep dry
Keep away from the sun
Do not use
if damaged
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
IGLBox Insulated
Box XL
IFU.IGLBox-XL Rev 02 (2017-11-09)
2004
Lid
IGLBox
Gel Pack (x2)
5