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x Data sheet Edi catheter, ENFit This document is intended to provide information to an international audience outside of the US.
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Edi catheter, ENFit - maquet.com · Edi catheter, ENFit ... Material in gastric tube ... The following table can be used as a guideline for which Edi catheter can be used with different

Apr 13, 2018

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Page 1: Edi catheter, ENFit - maquet.com · Edi catheter, ENFit ... Material in gastric tube ... The following table can be used as a guideline for which Edi catheter can be used with different

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Data sheet

Edi catheter, ENFit

This document is intended to provide information to an international audience outside of the US.

Page 2: Edi catheter, ENFit - maquet.com · Edi catheter, ENFit ... Material in gastric tube ... The following table can be used as a guideline for which Edi catheter can be used with different

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Page 3: Edi catheter, ENFit - maquet.com · Edi catheter, ENFit ... Material in gastric tube ... The following table can be used as a guideline for which Edi catheter can be used with different

General information

With NAVA, these signals are monitored by means of bipolar

electrodes mounted in the disposable Edi Catheter and positioned

in the esophagus at the level of the diaphragm. A range of models

of the catheter are available with different diameters (French) and

lengths. The catheter works as a normal nasogastric feeding tube.

Neurally Adjusted Ventilatory Assist (NAVA) is a mode of

mechanical ventilation, where the ventilator is controlled directly

by the patient's own neural control of breathing. The neural control

of respiration originates in the respiratory center, and signals are

transmitted through the phrenic nerve to create an electrical activity

of the diaphragm (Edi).

Edi catheter - general specificationsPolyurethane, medical grade (phthalate free)Material in gastric tube

Stainless steelMaterial in electrodes

10Number of electrodes

Barium sulfate stripX-ray identification

Gamma sterilizedSterile

2 yearsShelf life

< 5 daysUsage time

5 kV, according to IEC 60601- 1Test voltage class

440 * 300 * 190 mmDimensions for package of 5 catheters420 * 280 * 35 mmDimensions for individual catheter package

CommentTransport conditions-25 - +60 ºCAmbient temperature

including condensing0 - 95 % RHHumidity

470 - 1060 mbarAmbient pressure

CommentOperating conditions10 - 45 °CAmbient temperature

wet environment in esophagus15 - 100 % RHHumidity

esophagus pressure500 - 1500 mbarAmbient pressure

| Critical Care | Edi catheter, ENFit | 3 |

Technical specificationEdi catheter, ENFit

Page 4: Edi catheter, ENFit - maquet.com · Edi catheter, ENFit ... Material in gastric tube ... The following table can be used as a guideline for which Edi catheter can be used with different

Edi catheter selection guidelines

The following table can be used as a guideline for which Edi catheter can be used with different size of patients (neonate, pediatric,

and adult).

> 14075 - 16045 - 85< 55< 55< 55cm

kg1.0 - 2.01.0 - 2.00.5 - 1.5

16 / 125 or8 / 125

12 / 1258 / 1008 / 506 / 506 / 49Fr / cm

• LFT, total length of feeding tube

• dT, tube outer diameter

• dFL, feeding lumen inner diameter

• dFH, diameter of feeding holes

• IED, distance between electrodes

80 75 70 65 60 55 50

IED

LFT

dFH

dTdFL

| 4 | Edi catheter, ENFit | Critical Care |

Technical specificationEdi catheter, ENFit

Page 5: Edi catheter, ENFit - maquet.com · Edi catheter, ENFit ... Material in gastric tube ... The following table can be used as a guideline for which Edi catheter can be used with different

Dimensions for catheter size

6 Fr/49 cm6 Fr/50 cm8 Fr/50 cm8 Fr/100 cm12 Fr/125 cm8 Fr/125 cm16 Fr/125 cmSingleSingleSingleSingleDualSingleDualType of lumen

49 cm50 cm50 cm100 cm125 cm125 cm125 cmLFT

2.0 mm2.0 mm2.7 mm2.7 mm4.0 mm2.7 mm5.3 mmdT

0.8 mm0.8 mm1.2 mm1.2 mm2.4 mm1.2 mm2.9 mmdFL

0.9 mm0.9 mm0.9 mm0.9 mm2.0 mm0.9 mm2.0 mmdFH

6668121616IED

23348, every secondhole is angled

88, every secondhole is angled

Number offeeding holes

ENFitENFitENFitENFitENFitENFitENFitFeeding lumenconnector type

------------Luer femaleconnector withlid

---Luer femaleconnector withlid

Auxiliary Lumenconnector type

| Critical Care | Edi catheter, ENFit | 5 |

Technical specificationEdi catheter, ENFit

Page 6: Edi catheter, ENFit - maquet.com · Edi catheter, ENFit ... Material in gastric tube ... The following table can be used as a guideline for which Edi catheter can be used with different

Ordering information

Order numberQuantity/PackageEdi catheter name

68 83 9045Edi Cath. ENFit 16 Fr/125 cm 5/pkg

68 83 9035Edi Cath. ENFit 12Fr/125 cm 5/pkg

68 83 9025Edi Cath. ENFit 8Fr/125cm 5/pkg

68 83 9015Edi Cath. ENFit 8Fr/100cm 5/pkg

68 83 9005Edi Cath. ENFit 8Fr/50cm 5/pkg

68 83 8995Edi Cath. ENFit 6Fr/50cm 5/pkg

68 83 8985Edi Cath. ENFit 6Fr/49cm 5/pkg

| 6 | Edi catheter, ENFit | Critical Care |

Technical specificationEdi catheter, ENFit

Page 7: Edi catheter, ENFit - maquet.com · Edi catheter, ENFit ... Material in gastric tube ... The following table can be used as a guideline for which Edi catheter can be used with different

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Page 8: Edi catheter, ENFit - maquet.com · Edi catheter, ENFit ... Material in gastric tube ... The following table can be used as a guideline for which Edi catheter can be used with different

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Manufactured: Maquet Critical Care AB

171 54 Solna, Sweden

Phone: +46 (0) 10 335 73 00

www.maquet.com

Getinge Group is a leading global provider of products and systems that contribute to qualityenhancement and cost efficiency within healthcare and life sciences. We operate under thethree brands of ArjoHuntleigh, Getinge and Maquet. ArjoHuntleigh focuses on patient mobilityand wound management solutions. Getinge provides solutions for infection control withinhealthcare and contamination prevention within life sciences. Maquet specializes in solutions,therapies and products for surgical interventions, interventional cardiology and intensive care.

This document is intended to provide information to an internationalaudience outside of the US.

Edi catheter, ENFit may be pending regulatory approvals to be marketedin your country. Contact your Maquet representative for moreinformation.