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(pulse oximeter Nellcor ) SENSOR EXTENSION CABLE

https://unicat.msf.org/cat/product/41342
STD EEMDPOXA101

Valid Article

Former Code(s): EHOEZBD0076
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.
C900301 - Pulse oximeter sensors
European Medical Device Nomenclature (EMDN) is the nomenclature of use by manufacturers when registering their medical devices in the EUDAMED database. EMDN is characterised by its alphanumeric structure that is established in a seven-level hierarchical tree.
I
In Europe, medical material that fulfills the definition of a medical device according to the MDR (Medical Device Regulation) is classified into 4 classes
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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Nellcor SpO2 Cables

Definition

A non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. Some types may include an electrical isolator to prevent electrical shocks. This is a reusable device.

Specifications

reusable pulse oxymetry cable, intended for use with all patient populations for continuous non-invasive arterial oxygen saturation (SpO2) and pulse rate monitoring when used with compatible host device and SpO2 sensor.

Product compatibility 2021406-001 and 2021406-002

  • B850 with Nellcor OxiMax™ option with Tram module 451N5/851N5
  • B650/B450/V100/VC150 with Nellcor OxiMax option
  • Cardiolab/Mac-Lab with Tram module 451N5
  • Dash 2500/3000/4000/5000 with Nellcor OxiMax option
  • Solar 8000/8000M/8000i/9500 with Tram module 451N5/851N5
  • S/5, AS/3, CS/3 modular with E-NSATX
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Quality Standards Comment

In conformity with the requirements of the Medical Device Regulation 2017/745 and with the requirements of the RoHS Directive 2011/65/EU, article 4 on the restriction of the use of certain hazardous substances in electrical and electronic equipment.

Technical specifications

Interconnect cable with GE connector and Nellcor OxiMax Connector

Length cable 2021406-001 = 3m / 10 ft

Operating environment (= storage conditions)

  • Temperature: -30° to 60°C
  • Humidity: 10% to 90% RH
  • Pressure: 70 kPa to 106 kPa

Materials Cables: Polyurethane (PU), Thermoplastic Polyurethane (TPU), and Polycarbonate (PC) (not made with BPA, natural rubber latex, PVC, DEHP or other phthalates.)

Packaging & Labelling

Packaging materials Primary: Polyethylene (PE)

Instructions for use

Maintenance

Cleaning solutions

When needed, spray with or wipe with pad moisturized with 90% ethyl alcohol or 60% isopropyl alcohol or 2% glutaraldehyde. Although discoloration may occur, <10% sodium hypochlorite, 0.75% tartaric acid, <5% quarternary ammonium compounds, or <2% phenol may be used.