Hampton - Recommended Blood Pressure Monitors

Hampton - Recommended Blood Pressure Monitors




Hampton - Recommended Blood Pressure Monitors


Background

Currently, patients are monitored by frequent visits to the hospital to have their blood pressure and urine checked, this can be both inconvenient for patients and time-consuming. Monitoring women from home save both money, but more importantly, time for clinicians and women, this also means face to face visits only need to be conducted when required. However, It is important that the blood pressure machines women use are approved and safe to use during pregnancy. Therefore K2 has provided information to Blood pressure monitors that are approved for the use in Pregnancy to make the process of finding approved machines easier for you.

Devices for Home Blood Pressure Monitoring

This is a list of validated blood pressure monitors by STRIDEBP. They are an international scientific non-profit organization operating in affiliation with the European Society of Hypertension, the International Society of Hypertension and the World Hypertension League.

Preferred devices (13)
  1. Andon iHealth Track 
  2. Microlife 3AS1-2 
  3. Microlife WatchBP Home 
  4. Microlife WatchBP Home A
  5. Microlife WatchBP Home A BT
  6. Microlife WatchBP Home S
  7. Omron MIT Elite
  8. Omron BP760N (HEM-7320-Z)
  9. Omron Evolv (HEM-7600T-E)
  10. Omron HEM-9210T
  11. Omron M3 Comfort (HEM-7134-E)
  12. Omron M6 Comfort (HEM-7321-E)
  13. Omron M7 Intelli IT (HEM-7322T-E)

Validated devices (3)
  1. Microlife BP 3BTO-A
  2. Omron MIT
  3. Omron M7 (HEM-780-E)

Validated Blood Pressure Monitors for use in pregnancy - Verified by K2

Please note that K2 ONLY recommend the use of clinically validated blood pressure monitors for use in pregnancy and pre-eclampsia. K2 does not endorse any particular brand of blood pressure machine for home use but has only listed those were associated with evidence for use in pregnancy that can be easily found.

Microlife® automatic machines


Microlife® automatic machines are blood pressure monitors specifically for use in pregnancy and pre-eclampsia. They can be used at home and are intuitive to use, making it easy for women. A link has been provided to general guidance as well as links to the clinical evidence related to the blood pressure monitor

Website and General information:
 
Validation and compliance of a home monitoring device in pregnancy:

An accurate semi-automated oscillometric blood pressure device for use in pregnancy:

Microlife® Cradle VSA


Microlife® Cradle VSA  are blood pressure monitors specifically for use in pregnancy and can be used for home use. It is able to detect both shock and pre-eclampsia in pregnancy and is easy and intuitive for women to use.
The  Microlife® Cradle VSA is also recommended by action on pre-eclampsia - APEC ( https://action-on-pre-eclampsia.org.uk/professional-area/cradle-vsa-blood-pressure-monitor/#order)

A link has been provided to general guidance as well as links to the clinical evidence related to the blood pressure monitor

Website and General information:
 
Validation and compliance of an accurate blood pressure measurement device in pregnancy and pre-eclampsia:

Validation and compliance of a blood pressure device in a pregnant population with low blood pressure:


Temp-4-510.5.0 | Hampton - Recommended Blood Pressure Monitors


K2 Hampton™ bears a CE to denote conformity with the provisions of European Council Directive 93/42/EEC covering medical devices
· K2 Hampton™ is a Class I medical device 
· K2 Hampton™ is identified by the Basic UDI number: 506047038HamptonG2



Copyright © 2019. K2 Medical Systems Ltd. No part of this documentation may be stored in a retrieval system, transmitted or reproduced in any way, except in accordance with the terms of the applicable software license agreement. This documentation contains proprietary information of K2 Medical Systems Ltd. Patient data used within screenshots have been fabricated for the purpose of this manual.


Technical Support

If the User perceives a problem with the system, then this should be reported to a system administrator or senior staff member, in the first instance. If an issue cannot be resolved internally and the issue is directly attributed to K2 Hampton, then this should be escalated to K2’s support team, as per the Service Level Agreement.


Adverse Incidents

An adverse incident is an event that causes, or has the potential to cause, unexpected or unwanted effects involving the safety of device Users (including patients) or other persons as a result of a medical device failure or its misuse.


Further information can be found on the MHRA Website (UK), TGA Website (Australia) and HPRA Website (Ireland).


Should an adverse incident occur, or risk of an adverse incident increase, the appropriate K2 Support Team MUST be contacted at the earliest opportunity.


K2 Support UK & Ireland: 0044 (0) 1752 397 800, Opt 1 | support@k2ms.com

K2 Support Australia: 0061 (0) 3 8820 3160 | ausupport@k2ms.com


Address of Manufacture

K2 Hampton™ is produced by K2 Medical Systems at the following address:


K2 Medical Systems Ltd,

Summit View,

26 William Prance Road,

Derriford, 

Plymouth,

PL6 5WR, UK


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