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(EZ-IO) DRILL, sealed battery operated, ref 9058

https://unicat.msf.org/cat/product/18678
STD SINSNEIOK1-

Valid Article

CE marking: declaration that the product meets EU standards for health, safety, and environmental protection. The CE marking indicates that the product may be sold freely in any part of the European Economic Area, regardless of its country of origin.
IIa
In Europe, medical material that fulfills the definition of a medical device according to the MDR (Medical Device Regulation) is classified into 4 classes
The product is part of at least one Kit. A kit is a collection of products (medical and/or logistic) that are needed for a certain intervention in emergency. The choice and quantity of the articles reflects the MSF protocols for this specific situation. The use of Kits allows to start an intervention without a detailed evaluation.
OC subscriptions: included in supply or field order tools (e.g. UniField)
SC subscriptions: included in supply or field tools
OC validations: approved for procurement and use by an OC for international or local orders specifying context and activity in Medical Standard Lists (MSL)

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INTRA-OSSEOUS INFUSION SYSTEM

The intra-osseous needle set is worded and codified by single unit.

Definition

Battery powered medical drill and sterile medical devices needed to perform an intraosseous (IO) infusion (i.e., an infusion directly into the bone's medullary cavity) in children or adults.

Intraosseous infusion is used in emergency care when peripheral vascular acces is difficult, impossible or uneffective; especially for patients for whom immediate vascular access is lifesaving (e.g. patients with shock, severe dehydration, burns or cardiac / respiratory arrest)

Specifications

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Technical specifications

BATTERY POWERED MEDICAL DRILL (ref. 9058)

  • hand-held waterproof power driver
  • powered by sealed lithium battery
  • single use battery that cannot be replaced. The battery indicator (LED) will blink red when the trigger is activated and has only 10% of battery life remaining.
  • life expectancy: 10 years or +/- 500 insertions
  • no maintenance required
  • dimensions : 16.5 cm x 11.4 cm x 6.4 cm
  • weight: 315 g

NEEDLE + STABILIZER SET

  • 1 x EZ IO needle, 15G (Ø 1.8 mm)
    • austenitic stainless steel needle (18/8)
    • markings / 5 mm indicating depth, 5 mm of the catheter (at least one black line) must remain visible
    • Luer lock connector
    • with stylet for insertion and protective cap
    • sterile, for single use
    • length of the needle: :
      • paediatric (ref 9018P): 15 mm long, pink, for patients weighing between 3 to 39kg
      • adult (ref 9001P): 25 mm long, blue, for patients weighing more than 39kg
      • XL adult (ref 9079P): 45 mm long, for edematous or obese patients
  • 1 x EZ-CONNECT extension set
    • adapted to EZ IO PD needle
    • needed to connect the IO needle safely to the infusion set
    • ​with clamp
    • sterile, for single use
  • 1 x security wristband to document date and time of insertion
  • 1 x ADHESIVE DRESSING
    • sterile, single use
    • size : 14.6 cm x 13.3 cm x 3.2 cm
    • latex-free
  • 1 x NeedleVISE 1 port: device for securing the needle after insertion, to be disposed of in a sharps container.

TRANSPORT BAG for EZ-IO kit (ref 9065)

  • soft sided
  • yellow

Packaging & Labelling

Sterile peel-open pack for every needle set, including instructions for use.

The sets are packed per 5

Transport Dangerous Goods

  • UN3091: Lithium metal batteries packed with equipment
  • Class: 9
  • Packing instructions: 970 Section II
  • Limit per package:
    • Pax A/C (Passengers & Cargo Aircraft) = 5 kg
    • CAO (Cargo Aircraft Only) = 5 kg
Image

Instructions for use

To remove EZ-IO:

  • remove extension set and dressing
  • attach Luer-lock syringe to the catheter hub and withdraw the catheter by applying traction while rotating clockwise. Do NOT rock or bend the catheter.

The drill comes with instructions for use, to be consulted before applying.

Precautions for Use

  • Use moderate steady downward pressure and allow needle set to penetrate the bone, do NOT use excessive force!
  • Do not keep the perfusion for more than 24h after insertion.
  • Do not immerse the apparatus when performing cleaning and disinfecting.

Maintenance

  • The exterior surface of the drill can be cleaned and disinfected with a detergent/disinfectant for surfaces/non-invasive medical equipment. Prepare use-solution in concentration required. Always read the label and product information before use. Do not mix with other products. Make sure to wet the surface completely, use a wipe or towel, keep it wet for the whole exposure time.
  • Clean and disinfect also the trigger of the apparatus with the same detergent-disinfectant solution.
  • Using swabs, moistened with the detergent-disinfectant solution, gently clean the inside opening around the metal drive shaft.
  • After cleaning, inspect to ensure no visible debris remains, and no damage has occurred.
  • Dry the driver with a soft, clean cloth and store protected from humidity and dust (use the transport bag).

(Cf Introduction: Disinfection and sterilization in the field)

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