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SPHYGMOMANOMETER, one-hand manometer, velcro, pediatric

https://unicat.msf.org/cat/product/13654
STD EMEQSPHY1P-

Valid Article

Former Code(s): -X
Article is intended to be used with children (<12 years) ONLY.
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.
C9006 - Aneroid sphygmomanometers
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 measuring function
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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Manual SPHYGMOMANOMETER

Definition

A device designed to measure blood pressure consisting of an inflatable cuff that fits around a limb (arm or thigh), an inflation bulb for controlling the air pressure within the cuff, an aneroid manometer, and tubing.

The aneroid manometer consists of a metal bellows, which expands as the pressure in the cuff increases, and a mechanical amplifier that transmits this expansion through a lever to an indicator needle, which rotates around a circular, calibrated scale.

Blood pressure measurement is taken in conjunction with a stethoscope.

Synonym

blood pressure gauge

Specifications

Quality standards

ISO 81060-1, 2007, edition 1, (confirmed 2017) Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type

Technical specifications

Nylon pouch containing a cuff with inflatable bag connected via a tube to a bulb with manometer.

  • CUFF
    • made of nylon, non-deformable, washable at 30ºC
    • double Velcro fastening enabling the cuff to be tightly fitted around the arm
    • reinforced at both ends, very strong
    • EMEQSPHY1A-: 57 x 14.5 cm
    • EMEQSPHY1P-: 53 x 10.5 cm
  • INFLATABLE BAG
    • made of rubber
    • with flexible tube, 60 cm long, allowing quick and reliable connection (fits any type of inflation bulb)
    • autoclavable
    • EMEQSPHY1A-: 22 x 10 cm
    • EMEQSPHY1P-: 22 x 8.5 cm
  • MANOMETER WITH BULB
    • glass and metal aneroid pressure gauge with needle
    • graduations from 0 to 300 mmHg
    • rubber inflation bulb
    • pressure release valve

Instructions for use

Wash the cuff and the bag separately after detaching the manometer with bulb.

Deflate the bag completely after use by releasing the valve. Never press on the bag to deflate it more quickly since this can damage the valve.

A defective blood pressure gauge cannot be repaired and should be replaced.

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