1. Manuals
  2. Brands
  3. Una Health Manuals
  4. Medical Equipment
  5. Reflotron Plus
  6. Training manual

Una Health Reflotron Plus Training Manual

Hide thumbs
Table of Contents

Advertisement

Quick Links

Una Health Ltd
Author: E. C. Hamer
Date of Issue 26.04.10
Reflotron® Plus
Training Manual
Photocopied versions & handwritten amendments of this document are not controlled
Page 1 of 54
Document Control
UH-POC-TM-2 Revision 1
Printed 27 April 2010

Advertisement

Table of Contents
loading

Summary of Contents for Una Health Reflotron Plus

  • Page 1 Una Health Ltd Document Control Author: E. C. Hamer UH-POC-TM-2 Revision 1 Date of Issue 26.04.10 Reflotron® Plus Training Manual Photocopied versions & handwritten amendments of this document are not controlled Page 1 of 54 Printed 27 April 2010...

  • Page 2: Date Of Issue 26.04.10

    Una Health Ltd Document Control Author: E. C. Hamer UH-POC-TM-2 Revision 1 Date of Issue 26.04.10 This page is deliberately blank. Photocopied versions & handwritten amendments of this document are not controlled Page 2 of 54 Printed 27 April 2010...

  • Page 3: Date Of Issue 26.04.10

    Document Control Author: E. C. Hamer UH-POC-TM-2 Revision 1 Date of Issue 26.04.10 CONTACTS Una Health Ltd – Customer Support 01782 575180 Photocopied versions & handwritten amendments of this document are not controlled Page 3 of 54 Printed 27 April 2010...

  • Page 4: Date Of Issue 26.04.10

    Una Health Ltd Document Control Author: E. C. Hamer UH-POC-TM-2 Revision 1 Date of Issue 26.04.10 This page is deliberately blank. Photocopied versions & handwritten amendments of this document are not controlled Page 4 of 54 Printed 27 April 2010...

  • Page 5: Table Of Contents

    Una Health Ltd Document Control Author: E. C. Hamer UH-POC-TM-2 Revision 1 Date of Issue 26.04.10 CONTENTS Overview and Scope of this Training Guide CLINICAL BACKGROUND PRINCIPALS OF METHOD HAZARD WARNINGS RESPONSIBILITIES COLLECTION PROCEDURES SPECIMEN REQUIREMENTS EQUIPMENT/REAGENTS The Instrument Operational details...

  • Page 6: Date Of Issue 26.04.10

    Una Health Ltd Document Control Author: E. C. Hamer UH-POC-TM-2 Revision 1 Date of Issue 26.04.10 This page is deliberately blank. Photocopied versions & handwritten amendments of this document are not controlled Page 6 of 54 Printed 27 April 2010...

  • Page 7: Overview And Scope Of This Training Guide

    Una Health Ltd Document Control Author: E. C. Hamer UH-POC-TM-2 Revision 1 Date of Issue 26.04.10 Overview and Scope of this Training Guide The training session will cover the contents of this guide. It is not intended as a replacement for the Reflotron® Plus user manual nor is it intended to replace the inserts that are supplied with the individual test kits, but will provide a good basic understanding of the system.
  • Page 8 Una Health Ltd Document Control Author: E. C. Hamer UH-POC-TM-2 Revision 1 Date of Issue 26.04.10 This page is deliberately blank. Photocopied versions & handwritten amendments of this document are not controlled Page 8 of 54 Printed 27 April 2010...

  • Page 9: Clinical Background

    Una Health Ltd Document Control Author: E. C. Hamer UH-POC-TM-2 Revision 1 Date of Issue 26.04.10 CLINICAL BACKGROUND (All information, instructions and pictures referring to the Reflotron® Plus Analyser and Reagent Test strips are taken from the Roche/Diavant website and courtesy of E C Hamer BSc(Hons), MSc, FIBMS.) ®...
  • Page 10 Una Health Ltd Document Control Author: E. C. Hamer UH-POC-TM-2 Revision 1 Date of Issue 26.04.10 Glucose Measurement of blood glucose is predominantly indicated to screen for, to detect and to control hyperglycaemia due to diabetes mellitus as well as to monitor its treatment.
  • Page 11 Una Health Ltd Document Control Author: E. C. Hamer UH-POC-TM-2 Revision 1 Date of Issue 26.04.10 High-density lipoprotein cholesterol (HDL cholesterol) has anti-atherosclerotic and cardio protective properties. For this reason, there is an inverse association between HDL cholesterol and cardiovascular risk. A low HDL cholesterol level is an independent risk factor for atherosclerosis and coronary heart disease (CHD), even in individuals with low LDL cholesterol levels.
  • Page 12 Una Health Ltd Document Control Author: E. C. Hamer UH-POC-TM-2 Revision 1 Date of Issue 26.04.10 GPT (ALT) Glutamic-pyruvic transaminase (GPT) - also known as alanine aminotransferase or ALT - is a cytoplasmic hepatocellular enzyme, whose increase in blood is highly indicative for liver damage, e.g.
  • Page 13 Una Health Ltd Document Control Author: E. C. Hamer UH-POC-TM-2 Revision 1 Date of Issue 26.04.10 Uric acid Uric acid is the end product of purine metabolism. A large proportion of the purines in food will be reused, while the rest is degraded to uric acid. Up to 70 - 80 % of uric acid is excreted via the kidneys, and an additional 20 - 30 % leaves the body via the intestines.
  • Page 14 Una Health Ltd Document Control Author: E. C. Hamer UH-POC-TM-2 Revision 1 Date of Issue 26.04.10 Measuring Range >>8.5 - 205µmol/L Measuring Range >>2.59 – 12.9 mmol/L Measuring Range >> 37 C 24.4 - 1400 IU/L C 15.4 - 900 IU/L C 10.0 - 600 IU/L...
  • Page 15 Una Health Ltd Document Control Author: E. C. Hamer UH-POC-TM-2 Revision 1 Date of Issue 26.04.10 Measuring Range >>44.5 - 884 µmol/L Measuring Range >> 37 C 5.0 - 3500U/L C 3.85 - 2700U/L C 2.80 - 2000U/L Measuring Range >>0.56 – 33.3mmol/L Photocopied versions &...
  • Page 16 Una Health Ltd Document Control Author: E. C. Hamer UH-POC-TM-2 Revision 1 Date of Issue 26.04.10 Measuring Range >> 37 C 5.0 - 500U/L C 3.25 - 325U/L C 2.25 - 225U/L Measuring Range >> 37 C 5.0 - 2000U/L C 3.8 - 1520U/L...
  • Page 17 Una Health Ltd Document Control Author: E. C. Hamer UH-POC-TM-2 Revision 1 Date of Issue 26.04.10 Measuring Range >>5.0 – 20.0g/dl Measuring Range >>14 - 850U/L Measuring Range >>0.80 – 6.86mmol/L Photocopied versions & handwritten amendments of this document are not controlled...

  • Page 18: Hazard Warnings

    Una Health Ltd Document Control Author: E. C. Hamer UH-POC-TM-2 Revision 1 Date of Issue 26.04.10 Measuring Range >>3.33 – 50.0mmol/L Measuring Range >>120 - 1190µmol/L Measuring Range >>2.0 – 12.0mmol/L LDL cholesterol may be calculated using Cholesterol, Triglycerides, HDL results and...

  • Page 19: Responsibilities

    The healthcare provider on duty at the time a person accesses the service has overall responsibility for the service provision, whether or not they are personally undertaking the test. It must be someone who has been trained by Una Health Ltd that undertakes the test. Consultation area requirements The consultation area must be used to conduct the blood test and to communicate results.

  • Page 20: Collection Procedures

    Una Health Ltd Document Control Author: E. C. Hamer UH-POC-TM-2 Revision 1 Date of Issue 26.04.10 COLLECTION PROCEDURES Sample type – requires fingerstick collection of whole blood Healthcare provider must: • Wash & dry their hands thoroughly • Ensure any cuts or grazes are covered with a plaster •...

  • Page 21: Specimen Requirements

    Una Health Ltd Document Control Author: E. C. Hamer UH-POC-TM-2 Revision 1 Date of Issue 26.04.10 SPECIMEN REQUIREMENTS • Preferred volume of whole blood is 32µl. (minimum 30µl) • Sample material capillary or venous blood, heparinised/EDTA blood, plasma, serum (See Appendix 1 for individual tests as requirements do vary)) •...
  • Page 22 Una Health Ltd Document Control Author: E. C. Hamer UH-POC-TM-2 Revision 1 Date of Issue 26.04.10 EQUIPMENT & REAGENTS Equipment & Material Supplied: The Reflotron® Plus Analyser Power cable Keyboard Workstation Single use lancets Reflotron® test strips Clean & Check strips 32µl pipette &...
  • Page 23 Una Health Ltd Document Control Author: E. C. Hamer UH-POC-TM-2 Revision 1 Date of Issue 26.04.10 The Instrument. The Reflotron® Plus analyser Integral printer LCD display Measuring chamber lid On/Off button Specifications Analyser Weight – approx. 5.3 kg Size – 300 x 350 x 210mm Display –...
  • Page 24 Una Health Ltd Document Control Author: E. C. Hamer UH-POC-TM-2 Revision 1 Date of Issue 26.04.10 Operational details Connection to the power supply does not turn the analyser on, there is an on/off button on the front of the instrument Automatic start up procedure and a warming up time follow.
  • Page 25 Una Health Ltd Document Control Author: E. C. Hamer UH-POC-TM-2 Revision 1 Date of Issue 26.04.10 The Test Strips Magnetic strip located on the underside the test strip Sample Pad Reagent Layers • No preparation required • Storage conditions – most at RT (see Appendix 2 for individual tests) •...
  • Page 26 Una Health Ltd Document Control Author: E. C. Hamer UH-POC-TM-2 Revision 1 Date of Issue 26.04.10 METHOD Stage 1 - Preparation of the Test System Starting up the Reflotron® • Ensure that the Reflotron® is set up away from direct sunlight and sources of heat (radiators, heaters or instruments that radiate heat).
  • Page 27 Una Health Ltd Document Control Author: E. C. Hamer UH-POC-TM-2 Revision 1 Date of Issue 26.04.10 Running a Clean & Check Strip • Open the container and remove one Check Strip, replace lid • Open the lid of the measuring chamber and insert the check strip.
  • Page 28 Una Health Ltd Document Control Author: E. C. Hamer UH-POC-TM-2 Revision 1 Date of Issue 26.04.10 What to do if check strips are out of range Check strip FAIL (Readings out of range) Clean lens, and upper and lower heater blocks with alcohol. Wait 30 minutes.
  • Page 29 Una Health Ltd Document Control Author: E. C. Hamer UH-POC-TM-2 Revision 1 Date of Issue 26.04.10 • The values obtained on the instrument should not vary significantly from week to week and must always lie within the minimum and maximum values as specified on the label of the vial.
  • Page 30 Una Health Ltd Document Control Author: E. C. Hamer UH-POC-TM-2 Revision 1 Date of Issue 26.04.10 Stage 2 – Performing the test Step 1 • Remove the appropriate test strip from the container and place on a flat clean surface •...
  • Page 31 Una Health Ltd Document Control Author: E. C. Hamer UH-POC-TM-2 Revision 1 Date of Issue 26.04.10 Step 3 a) For single test • Insert a 32µl capillary tube into the applicator device • Gently squeeze the patient’s finger and release to allow blood flow.
  • Page 32 Una Health Ltd Document Control Author: E. C. Hamer UH-POC-TM-2 Revision 1 Date of Issue 26.04.10 • Apply cotton wool pad with pressure to the customer’s finger until the bleeding stops, discard the cotton wool pad as clinical waste and offer a plaster.
  • Page 33 Una Health Ltd Document Control Author: E. C. Hamer UH-POC-TM-2 Revision 1 Date of Issue 26.04.10 • The Reflotron® will read the magnetic strip on the reverse of the test strip • Countdown of test will appear on the screen.
  • Page 34 Una Health Ltd Document Control Author: E. C. Hamer UH-POC-TM-2 Revision 1 Date of Issue 26.04.10 NB. Some tests require a sample of plasma (refer to Appendix 2 for individual test sample requirements) In this event, the whole blood sample collected as described in Step 3 b) Page 31...
  • Page 35 Una Health Ltd Document Control Author: E. C. Hamer UH-POC-TM-2 Revision 1 Date of Issue 26.04.10 Stage 3 – Reviewing the Results The Healthcare provider should review the results against the referral criteria and advise the client of the next appropriate steps...

  • Page 36: Internal Quality Control (Iqc)

    Una Health Ltd Document Control Author: E. C. Hamer UH-POC-TM-2 Revision 1 Date of Issue 26.04.10 INTERNAL QUALITY CONTROL (IQC) (All information, instructions and pictures referring to the Reflotron®® A1C Quality Control are taken from the QC pack insert) Running a Quality Control (QC)
  • Page 37 Una Health Ltd Document Control Author: E. C. Hamer UH-POC-TM-2 Revision 1 Date of Issue 26.04.10 QC should be run:- • With each new lot of test strips. • With each new shipment of test strips. • Whenever there is any concern that the test result may be wrong; test strips not stored correctly;...
  • Page 38 Una Health Ltd Document Control Author: E. C. Hamer UH-POC-TM-2 Revision 1 Date of Issue 26.04.10 Running the controls Preparing the Reflotron® test strip • Remove the appropriate strip from its container and replace lid • Place strip on a clean dry surface Adding the control •...
  • Page 39 Una Health Ltd Document Control Author: E. C. Hamer UH-POC-TM-2 Revision 1 Date of Issue 26.04.10 What to do if the Reflotron® QC results are unacceptable QC FAIL (Readings out of range) Check expiry dates of QC material & test strips...
  • Page 40 Una Health Ltd Document Control Author: E. C. Hamer UH-POC-TM-2 Revision 1 Date of Issue 26.04.10 Training/Competency Assessment Method Steps Pass/Fail Sign/Comments Preparation of Preparation of the test Reflotron® system Analyser Carried out correct preparation of – self & patient...
  • Page 41 Una Health Ltd Document Control Author: E. C. Hamer UH-POC-TM-2 Revision 1 Date of Issue 26.04.10 Correct placement of test strip in analyser Successful test IQC on Reflotron® analyser (cont) Read the results Reviewed the results The Reflotron® Analyser Understands Results Health &...

  • Page 42: Training Knowledge Assessment

    Una Health Ltd Document Control Author: E. C. Hamer UH-POC-TM-2 Revision 1 Date of Issue 26.04.10 Training Knowledge Assessment Please answer on sheets provided over page. 1) What is the storage temperature of the Reflotron® test strips? 2) What is the purpose of QC?
  • Page 43 Una Health Ltd Document Control Author: E. C. Hamer UH-POC-TM-2 Revision 1 Date of Issue 26.04.10 Training Knowledge Assessment (cont) Answers Photocopied versions & handwritten amendments of this document are not controlled Page 43 of 54 Printed 27 April 2010...
  • Page 44 Una Health Ltd Document Control Author: E. C. Hamer UH-POC-TM-2 Revision 1 Date of Issue 26.04.10 Training Knowledge Assessment (cont) Answers Photocopied versions & handwritten amendments of this document are not controlled Page 44 of 54 Printed 27 April 2010...
  • Page 45 Una Health Ltd Document Control Author: E. C. Hamer UH-POC-TM-2 Revision 1 Date of Issue 26.04.10 Training Knowledge Assessment (cont) Complete your details below: Name Position Test site Signature Date Training representative to complete and confirm the training knowledge assessment has been passed and the above person is confident and competent...

  • Page 46: Appendix 1 - Basic Troubleshooting

    Una Health Ltd Document Control Author: E. C. Hamer UH-POC-TM-2 Revision 1 Date of Issue 26.04.10 Appendix 1 - Basic Troubleshooting Message/Problem Description Resolution Cannot read magnetic strip When strip inserted & lid Clean magnetic strip reader closed, magnetic strip not &...
  • Page 47 Una Health Ltd Document Control Author: E. C. Hamer UH-POC-TM-2 Revision 1 Date of Issue 26.04.10 Appendix 2 – Reflotron® test strips general information Reflotron®® Tests Storage Sample Indications Strips temp type Reflotron® Alkaline + 2°C to + Liver disorders, bone disorders Phosphatase 30°C...
  • Page 48 Una Health Ltd Document Control Author: E. C. Hamer UH-POC-TM-2 Revision 1 Date of Issue 26.04.10 Appendix 3 – The keyboard functions Any key PSI in the 1 line Key F2 CHD risk calculator Key F3 LDL calculation according to Friedewald...

  • Page 49: Appendix 4 – Risk Assessment

    Una Health Ltd Document Control Author: E. C. Hamer UH-POC-TM-2 Revision 1 Date of Issue 26.04.10 Appendix 4 - Risk Assessment Hazard Identification HAZARDS Control Measures Risk Low/Med/High Manual Small analyser Weight – approx. 5.3 kg Handling Size – 300 x 350 x 210mm...
  • Page 50 Una Health Ltd Document Control Author: E. C. Hamer UH-POC-TM-2 Revision 1 Date of Issue 26.04.10 Persons at Risk? - Staff & Patients Is a significant risk assessment required? - NO (A significant risk assessment is required should any medium/high risks be identified) Elizabeth C Hamer BSc.( Hons)., MSc., FIBMS...

  • Page 51: Appendix 5 – Coshh

    Una Health Ltd Document Control Author: E. C. Hamer UH-POC-TM-2 Revision 1 Date of Issue 26.04.10 Appendix 5 - COSHH Assessment 1. General description of work Point of Care testing for 17 different chemistry analytes. 2. Specific activity assessed Use of Reflotron® Plus Analyser & Reagent strips 3.
  • Page 52 Una Health Ltd Document Control Author: E. C. Hamer UH-POC-TM-2 Revision 1 Date of Issue 26.04.10 7. Identify the possible route/s Circle of exposure. Inhalation Ingestion Absorption Eye contact 8. Evaluate the risk without Circle as appropriate controls in place.
  • Page 53 Una Health Ltd Document Control Author: E. C. Hamer UH-POC-TM-2 Revision 1 Date of Issue 26.04.10 11. Further notes on working practice Disposal – reagent strip to be disposed of in a clinical waste container 12. Spillage procedure 13.First Aid 14.

  • Page 54: References

    Una Health Ltd Document Control Author: E. C. Hamer UH-POC-TM-2 Revision 1 Date of Issue 26.04.10 References MHRA Device Bulletin: Management & use of IVD Point of Care Test Devices; DB2010 (02) Feb 2010. UK Health Depts., Guidance for Clinical Healthcare Workers: Protection against infection with Blood Bourne Viruses, Dept.

Table of Contents