Initiating HBPM:

Discussing HBPM with the patient:

The following should be explained to the woman:

• there is a need to monitor her BP more frequently 
  
• the purpose of HBPM is to reduce the number of unnecessary visits and offer the patient some control in the monitoring of her BP.
  
• the importance of compliance and accurately recording the results.
  
• she should contact DAU (or labour ward out of hours) if she has any abnormal readings or symptoms of severe hypertension/pre-eclampsia (persistent headache, visual disturbance, vomiting, facial swelling, upper abdominal pain) or reduced fetal movements.
  

Teaching HBPM technique to a patient:

• The machines provided to patients are Microlife® automatic machines.
  
• These machines are calibrated for use in pregnancy and are the only monitors we recommended for the use of HBPM.
  
• Link provided to further information: https://www.microlife.com/professional-products/watchbp-home/watchbp-home
• Each patient will be loaned their own machine for the duration of monitoring in pregnancy. The machines are numbered and the patient’s details should be documented next to the appropriate number in a log book.
  

• An appropriate cuff size should be provided for the patient (see table 1).
  
• Advise the patient to take their BP when they are relaxed and have been sitting down for 5 minutes. They should take their BP from the same arm each time.
  
• Demonstrate to the patient how and where to site the cuff. The bottom edge of the cuff should sit 2cm above the antecubital fossa (elbow fold) and the artery mark on the cuff should line up with the brachial artery (the inside front of the arm). The cuff should be done up so that it stays on, but not too tightly.
  
• Demonstrate to the patient how to start the machine to record the BP (Press the ‘POWER’ button once and it will automatically start recording).
  
• Once recorded, show them which numbers to record as systolic and diastolic BP. Demonstrate the re-call function to obtain the last recorded BP.
  
• If the patient is to perform urinalysis at home, show them how to use the dipsticks.

Table 1: Cuff size selection

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