CRADLE Vital Signs Alert (VSA) Monitor

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The CRADLE Vital Signs Alert (VSA) Monitor is a digital blood pressure monitor that incorporates an algorithm for the detection of hypovolemic shock. Intelligent and user friendly, this life-saving device is used to accurately detect pre-eclampsia and shock in pregnant women during delivery.
• Minimum Order Quantity (MOQ): 20 devices
• Seller Name: MicroLife Health Management
• Seller Location: Netherlands
• Warranty Term: 2 years
• Regulatory Approval: CE, ISO 13485

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Description

The CRADLE Vital Signs Alert (VSA) Monitor helps detect and alert of pre-eclampsia and shock due to sepsis and obstetric hemorrhage. It is a non-invasive digital blood pressure monitor that uses oscillometric technique and an upper-arm blood pressure cuff to measure systolic and diastolic blood pressures according to Korotkoff Phase I (for SBP) and V (for DBP). The device also incorporates an algorithm for the detection of hypovolemic shock using Shock Index (heart rate divided by systolic blood pressure). The device is easy to use to recognize pre-eclampsia and shock thanks to a visual 'traffic light' early warning system. The CRADLE VSA can accurately measure non-invasive blood pressure in people aged 12 years or older. It can be used for both non-pregnant and pregnant patients.

Key Features

Usability
The device features a “traffic light” early warning system that uses the traditional red, yellow and green colored lights. The user-friendly system indicates when a patient has pre-eclampsia or sepsis, even if the user has not undergone formal training.

Reliability
The CRADLE VSA combines the advantages of an automatic blood pressure monitor and auscultatory sphygmomanometer designed to provide convenient, accurate and reliable blood pressure measurements according to guidelines of the British Hypertension Society (BHS) and World Health Organization (WHO).

Specifications

Measurements

  • Dimensions: 167 mm x 60 mm x 41 mm
  • Weight: 157.7 g (including battery)

Performance

  • Measuring Procedure: Oscillometric, corresponding to Korotkoff method Phase I systolic, Phase V diastolic
  • Pulse Measurement Range: 40 – 200 beats per minute
  • Blood Pressure Measurement Range: 30 – 280 mmHg
  • Cuff Pressure Display Range: 0 – 299 mmHg
  • Resolution: 1 mmHg
  • Static Accuracy: Pressure within ± 3 mmHg
  • Pulse Accuracy: ± 5 % of the readout value

Power

  • Voltage Source: Li-ion (3.7 V , 350 mAh) rechargeable via standard MicroUSB
  • Battery Life: Approximately 200 measurements per recharge cycle

Operating Conditions

  • Temperature: 10 – 40°C / 50 – 104°F
  • Relative Maximum Humidity: 15 – 90%

Storage Conditions

  • Temperature: -20 – +55°C / -4 – +131°F
  • Relative Maximum Humidity: 15 – 90%

General Information

  • Reference to Standards: ANSI/AAMI/ISO 81060-2; EN 1060-1/-3/-4; IEC 60601-1; IEC 60601-1-2 (EMC); IEC 60601-1-11
  • Expected Service Life: 5 years or 10,000 measurements (battery and cuff are not included)
  • IP Class: IP20

Standard Accessories

  • Blood pressure cuff – size M (1x)

Optional Accessories & Add-ons

  • Additional blood pressure cuff (size M, L or XL)

Product Documents, Manuals & Brochures

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Manual

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Application Guide: Community

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Application Guide: Clinic

Regulatory Certificates

United States, Canada
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CE Certificate

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ISO 13485

9001

ISO 9001

Videos

FAQ

How does the CRADLE VSA compare to standard digital blood pressure monitors?
Most digital blood pressure devices have never been formally validated as accurate pregnant women especially those with elevated blood pressure. Some can underestimate BP by as much as 30mmHg. As such, new readings from the CRADLE VSA may seem higher or lower than usual to users who are unfamiliar with the device, but they need to consider that this is because this may be the first time that they have been able to measure BP accurately. In addition, the CRADLE VSA is able to pick up VERY low readings and VERY high readings that other devices may not be able to measure.
How does the CRADLE VSA compare to standard mercury sphygnomometers?
When comparing the CRADLE VSA to a mercury sphygnomometer it is helpful to consider the problems associated with measuring BP using auscultation. Auscultation requires skill and training. It is easy to get inaccurate readings from deflating the cuff too fast or not hearing the sounds clearly. If this is the preferred method of blood pressure measurement then it can also be used on the CRADLE VSA. You can auscultate and watch the digital numbers decrease on the screen as the cuff deflates instead of the column of mercury. Therefore, you can test that what you hear is the same as the VSA shows you. This can be a helpful technique to prove the accuracy of the device to yourself and others, rather than comparing to other, non-validated, devices.
How is the battery life of the CRADLE VSA?
When first switching on the CRADLE VSA, it will show a small battery sign on the bottom right of the screen. This is part of the start up screen and does not reflect the battery status.
When this sign persists on the screen it indicates that the battery is starting to become low but around 100 readings can be taken prior to the battery completely draining. These measurements will be as accurate as when the battery is full. The CRADLE VSA cannot give false readings, even if the battery is low. You should therefore not charge the device every time you see this otherwise you will damage the battery life. Instead only charge when the battery is nearly/completely drained and the VSA does not turn on. This will preserve the battery life. You will be provided with sufficient VSA to ensure you have spare devices fully charged at all times to avoid interruptions to care.

Package Contents

  • 1x CRADLE Vital Signs (VSA) Monitor Main Unit
  • 1x Blood pressure cuff – size M
  • 1x Micro USB to USB cable
  • 1x User manual

Warranty

This device is covered by a 2 year guarantee from the date of purchase.
• Battery and wearing parts are not included.
• The cuff is included for the functional guarantee only (tightness) for 1 year.
• Opening or altering the device invalidates the guarantee.
• The guarantee does not cover damage caused by improper handling, discharged batteries, accidents or non-compliance with the operating instructions.

Testimonials

Not available at this time

 

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