Siemens Healthcare Diagnostics Inc.

Support Bulletin RP400-059

Informational
2009-04
Effect of Cleaners on RapidPoint 400/405 Series Sensors

NOTE: This information is provided as an aid in Technical Support for trained support
personnel. Do not attempt to service the system without the appropriate technical training
and the proper tools.
Purpose To remind branches of the effects benzalkonium has on the
RapidPoint 400/405 sodium and potassium sensors, and to help
identify cleaners that cause adverse effects on the sodium and
potassium sensors.
Product RapidPoint 400/405 Series
Applicability All RapidPoint 400/405 customers using cartridge types that
include the electrolyte sensors; see part numbers below.
Attachments N/A.
References 2008-0517-EUR-NPT
2008-0559-EUR-NPT
2007-0071-EUR-NPT
2007-0538-NA-NPT

Part Numbers
Description Part Number

RP400 M-Cart Full 750 07156411

RP400 M-Cart Full 400 09283844
RP405 M-Cart Full + CO-ox 750 04913211
RP405 M-Cart Full + CO-ox 400 00724090
RP405 M-Cart Full + CO ox 250 10283222

Problem
Field reports suggest that customers are looking for alternatives to bleach as an
instrument cleaning agent. In some cases cleaners containing long chain quaternary
ammonium compounds are being used as a replacement for bleach, and these can have a

2009 Siemens Healthcare Diagnostics Inc. All rights reserved.

Siemens Healthcare Diagnostics Inc., Tarrytown, NY 10591-5097 USA
For internal use only by Siemens Healthcare Diagnostics and associated companies authorized to provide
service and support for Siemens products. Not for general distribution.
18275 Rev. A, 2009-04 Page 1 of 3
Effects of cleaners on the RapidPoint 400 / 405 series sensors

damaging effect on the sodium and potassium sensors inside the RapidPoint 400/405
cartridges. Quaternary cleaners can affect the sensor reading and cause un-flagged outlier
results. Therefore the quality of the sample result may unknowingly be compromised by
the use of these cleaners.

Background Information
Our Operators Manual currently states:

CAUTION: Do not use any solutions containing the benzalkonium chloride ion.
Do not wet the sample port or the sensor contacts for the measurement and
AutomaticQC cartridges. When cleaning surfaces do not spray cleaning solution or
other fluids into or on the sample port or the area behind the measurement and
AutomaticQC cartridge. For Rapidpoint 405 systems, do not spray cleaning solutions
or other fluids on the optics head assembly. The sensor contacts and the optics head
assembly, which are located behind the measurement cartridge, may be damaged if
they get wet. Sensors, in the cartridge, may be damaged if cleaning solution enters the
sample port.

It is important to remind customers that they should avoid the use of cleaning sprays and
wipes that contain benzalkonium ion, quaternary ammonium compounds, and
surfactants when cleaning the instrument

The sodium sensor is the detection method for benzalkonium exposure

Many disinfectant sprays and wipes contain Benzalkonium and other agents that may
interfere with the Rapidpoint400 sensors. The quaternary ammonium compounds found
in these cleaners can cause sodium to be out calibration for as long as several days.

When sodium calibrates without a D2 error the system exits benzalkonium retro-
calibration. The time from the previous calibration to the calibration with no D2 must be
greater than 20 minutes.

Benzalkonium heparin is typically found on catheters. Sodium recovers within a few

hours after benzalkonium heparin exposure from a catheter.

Benzyl alcohol, benzalkonium chloride, and benzalkonium heparin may interfere with
sodium and potassium measurements, depending on the specific measuring technology
for each analyte. Benzyl alcohol and benzalkonium chloride may be inadvertently
introduced into the sample if used as an antiseptic at the blood withdrawal site, or if
added as a preservative to the heparin anticoagulant solution. Manufacturers of catheters
may treat the catheter tubing with benzalkonium heparin to prevent clot formation.
Blood samples withdrawn from a catheter so treated or impregnated with benzalkonium
salts may yield erroneous results until this compound is completely leached out. For these

For internal use only.

18275 Rev. A, 2009-04 Page 2 of 3
Effects of cleaners on the RapidPoint 400 / 405 series sensors

samples users should select the mixed venous sample mode, as clearly stated in the
manual.

Action
Information on avoiding benzalkonium cleaners is clearly stated in the Rapidpoint 400
Series Operators Manual.
These substances can be present in antiseptic wipes, and cleaning wipes and sprays. It is
also possible for cleaners used to clean the area around the instrument to have an effect
on the sensors.
It is important to remind customers to avoid the use of cleaning sprays and wipes that
contain benzalkonium ion, quaternary ammonium compounds, and surfactants.

Regulatory
Two recent MDRs have been filed with the FDA for this issue.
There is no safety hazard.

Issued By
This document is issued by Kevin Sheldrake, Global Product Support and Service.

Trademark Information
RapidPoint is a trademark of Siemens Healthcare Diagnostics.

For internal use only.

18275 Rev. A, 2009-04 Page 3 of 3