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ELECTRONIC SPHYGMOMANOMETER, manual inflation(Microlife VSA)

https://unicat.msf.org/cat/product/71626
STD EMEQSPHY5--

Valid Article

Former Code(s): EEMDSPHE3--
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.
Z1203020302 - Non–invasive blood pressure monitoring instruments
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.
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
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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ELECTRONIC SPHYGMOMANOMETER, Microlife VSA

Definition

Handheld semi-automatic oscillometric device to measure blood pressure in people aged 12 years or older.

An electronic device, typically digital, designed to noninvasively measure blood pressure using a manually-inflated cuff that fits around the arm. It displays current heart rate in addition to systolic and diastolic blood pressures; it has memory to store blood pressure values and a visual warning system if blood pressure exceeds pre-set limits. This device is designed to be portable (e.g., hand-held or carried in a pouch).

Synonym

Vital Signs Alert - CRADLE device

Vital Signs Monitor (Cradle) for pregnant women

Specifications

The device incorporates a traffic light early warning system, aiming to alert in a visual way (color code) to abnormalities in vital signs secondary to pre-eclampsia or shock (due to bleeding or sepsis). It is suitable for use in low-resource settings according to WHO criteria.

  • measuring unit:
    • ON/OFF button
    • LCD-display
    • cuff socket
    • battery compartment
    • Micro USB port (for charging only)
    • traffic light
    • charging indicators
  • cuff: the VSA device comes with a medium cuff as standard
  • cuff connector
  • pump ball: for manual inflation of the cuff
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Technical specifications

  • Weight: 157.7 g (including battery)
  • Dimension: 167 x 60 x 41 mm
  • Display: LCD-Display (Liquid Crystal Display)
  • Measuring procedure: oscillometric, corresponding to Korotkoff method Phase I systolic, Phase V diastolic.
    • measurement range: 30-280 mmHg blood pressure
    • 40-200 beats per minute-pulse
    • cuff pressure display range: 0-299 mmHg
  • Resolution: 1 mmHg
  • Static accuracy: pressure within ± 3 mmHg
  • Pulse accuracy: ± 5% of the readout value
  • Voltage source: specify battery type (3.7V, 350 mAh), rechargeable via standard MicroUSB
  • Battery life: approx. 200 measurements per recharge cycle

Supplied with the Article

  • Cuff size M for circumference of upper arm 22 - 32 cm
  • Battery type 3.7V, 350 mAh, rechargeable via standard MicroUSB
  • USB cable

To be Ordered Separately

Cuff size L for circumference of upper arm 32 - 42 cm

Instructions for use

Read carefully the user manual

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Maintenance

  • Device care: Clean the device only with a soft, dry cloth
  • Cleaning the cuff: take out the bladder. Clean the cuff with warm water and soap detergent. Air dry.

Storage

Do not expose the device to either extreme temperatures,
humidity, dust or direct sunlight.

  • Storage conditions: -20 - +55 °C; 15 - 90 % relative maximum humidity
  • Operation conditions: 10 - 40 °C; 15 - 90 % relative maximum humidity

MSF requirements

Meets the World Health Organisation (WHO) criteria for devices suitable for in low-resource settings

It can be used with USB phone chargers.

Requires minimal training. It is meant for monitoring antenatal blood pressure screening in pregnant women in remote areas by health community workers or trained health workers to facilitate the decision of referring the pregnant women to a hospital structure.

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