Braun Omnitest 5 User manual

Blood Glucose Measurement
Omnitest®5
GET CONNECTED, TAKE CONTROL
ISO 15197: 2013
TECHNICAL INFORMATION
Measurement range 0.6–33.3 mmol/L or
Haematocrit 20 – 60 %
Calibration Plasma
Enzyme GDH-FAD
Operating temperature 10 °C– 40 °C or 50 °F – 104 °F
Operating humidity 10 – 90 %
Screen type Backlit
Dimensions 78 mm x 43 mm x 16 mm
(L x W x H)
Power supply 2 x 3V lithium batteries
(CR2032)
Battery life min. 1,000 tests
Data transfer
to a computer
Via standard micro-USB/
USB cable
Online solutions:
Diasend®,
www.omnitestcenter.com
B. Braun Medical Ltd | OPM | Thornclie Park | Sheeld | S35 2PW
Tel [phone] | Fax [phone] | www.bbraun.co.uk
XX-OT5B-06-18
PRODUCT OVERVIEW REFERENCE PIP CODE
Omnitest®5
Set mmol/L white 9552652MMGB
Set mmol/L black 9552855MMGB
Test strips 2 x 25 9552709WE 402-0335
Control solution (M + H) 9552768DE
Micro USB cable 9552856G
Omnican®Lance
Lancing device 9167927
Omnican®Lance soft
Sterile lancets 30G (200 pc) 9167510E 377-3322
Omnitest®5 Set contains
blood glucose meter pre loaded with 2 batteries
check strip
protective meter case
10 test strips
lancing device
10 lancets
For further information or to place an order please contact:
Tel: Freephone 0800 840 0498
Email: [email protected]
www.diabetes-bbraun.co.uk
References
1. B. Braun Melsungen AG carried the system accuracy tests out in KEPCO Medical Center in Korea.
...anytime, anywhere.
Handwritten diaries are no longer the only way of documenting the relevant data from
your diabetes therapy. There are numerous solutions to help manage your diabetes:
Omnitest®5 App - can assist with your self management, allowing you to connect to your
phone, monitor trends in your blood glucose readings and take control.
Diasend -allows you to upload and present your information in clear and structured
reports. This enables patients and healthcare professionals to easily share, access and
understand the data. Please request a Diasend - micro-USB cable (95528569)
www.omnitestcenter.com -your electronic diary allows you to upload and access your
data on any device connected to the internet. Please request a Standard USB cable
(91528569)
Your glucose patterns...
To start analysing your data you will need a USB cable, simply call our diabetes customer
care line 0800 840 0498 or email [email protected].

RESULT 98.3 % of results are within ±0.83 mmol/L or ± 15 % for combined lots.
CONCLUSION Omnitest® 5 exceeds ISO 15197:2015 criteria.
Omnican®Lance lancing device
Ideal for patients with poor
manual dexterity
Single handed use
7 nely graduated depth
settings for dierent skin
types
Coloured signal upon loading
Safety lock prevents misfiring
Omnican®Lance soft lancets
Gentle puncture and ideal
blood ow
Silicone oil coated tip
Three-facets grinding
Maximum comfort with
a thin 30G (ø 0.30 mm) or
28G (ø 0.36 mm) lancet tip
Screw on/o
adjustable tip
Signal window
Release button
Lancet ejector
Slide for loading
MEETS ALL REQUIREMENTS
OF ISO 15197: 2015
Easy grip
Large backlit screen
Strip ejector
Backlit test strip port
User-friendly
navigation
Micro-USB port for
data transfer
Omnitest®5 Omnican®Lance
Dierence plot of system accuracy of 3 x 200 blood glucose samples with
Omnitest®5 compared to YSI 2300 in a hospital using 3 lots of test strips
System Accuracy¹
ACCEPTANCE CRITERIA
ACCURACY PLOT – PART 1
ACCEPTANCE CRITERIA
ACCURACY PLOT – PART 2
RESULT 100 % of results are within zones A and B of the consensus error grid.
CONCLUSION Omnitest®5 exceeds ISO 15197:2015 criteria.
Omnitest®5 meter
Bluetooth connectivity
500 test memory
Average results for 7,
30 and 90 days
Marking function
5 standard alarms and
timer
Target level function
Omnitest®5 test strips
GDH-FAD enzyme
technology
0.5 µL sample volume
5 seconds test time
Underdosage warning
Automatic coding
Compatible with fresh
capillary or venous
whole blood
REQUIREMENT
95% of glucose levels <5.55 mmol/L should
be within ±0.83 mmol/L of laboratory results
95% of glucose levels ≥ 5.5 mmol/L should
be within ± 15% of laboratory results
REQUIREMENT
99 % of results should fall within zones A
and B of the consensus error grid