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.

Below are two sections, the first is blood pressure monitors that have been recommended for use in pregnancy by STRIDEBP. The second are monitors that K2 could independently verify for evidence associated with use in pregnancy and pre-eclampsia.

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.

https://stridebp.org/bp-monitors

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

Microlife® Cradle VSA

K2 Hampton™ bears a UKCA to denote conformity with the provisions of Medical Device regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002).

• K2 Hampton™ is a Class I medical device
• K2 Hampton™ is identified by the Basic UDI number: 506047038HamptonG2

Copyright © 2024. 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 has been fabricated for the purpose of this manual. Replication of these is strictly prohibited, unless in context with their associated purposes i.e. K2 Medical Systems™, or K2 products.

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 is directly attributed to K2 Hampton, then this should be escalated to the 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:

Should an adverse incident occur, the K2 Support Team and the applicable regulatory authority MUST be contacted at the earliest opportunity.

Address of Manufacture

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

K2 Medical Systems Ltd
The Apex
Derriford Business Park
Brest Road
Plymouth
PL6 5FL
United Kingdom