BLOOD BAG TUBE SEALER (Delcon HemoWeld T), 115-230V

STD ELAESEAE1--

Valid Article

Former Code(s): ELAEZBE0929 ELAEZFR0665
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.
W02029010 - Bag sealers
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.
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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BLOOD BAG TUBE SEALER

Definition

Bench tube sealer for blood bags designed for laboratory use.

Specifications

Quick sealing procedure in less than two seconds for blood bag tubing.

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Quality standards

  • IEC 60601-1, 2022, edition 1, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
  • IEC 60601-1-2, 2014, edition 4, +A1 2020 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests

Components

  • Power cord
  • Operator and maintenance manual

Technical specifications

  • Optical and acoustic signals for humidity or dirt presence on the electrodes
  • Signal of sealing executed
  • Secondary RF (Radio Frequency) output for optional sealing handgun
  • Working frequency 40.680MHz
  • For medical PVC tubes with outer diameter up to 5 mm
  • Operating conditions
    • temperature : 10-40°C
    • relative humidity 10-90% without condensation
  • Power supply: mains AC
    • Voltage: 115 / 230 V, 50/60 Hz (voltage selector on back)
    • Energy consumption: 420 VA
  • Protection against electric shocks
    • Class 1

Dimensions

  • Dimensions net (DxHxW): 200 x 120 x 220 mm
  • Dimensions with package: 450 x 410 x 400 mm
  • Weight net and with package: 5.8 kg – 8.2 kg

Instructions for use

Read carefully the user manual

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Precautions for Use

  • Never try to pull or move the tube while sealing is in progress.
  • The device must not be used on tubing still connected to a donor arm.
  • Never touch the electrodes while sealing.
  • Never place any metallic objects or any other object between the electrodes.
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