Page 47 - Kit LUMIS CHU de RENNES Intervention le 16-03-2017

Instructions for Cleaning, Sterilization, Inspection and
®
Maintenance of SpineVision medical devices
English version

Application date : 2015-12-09 Reference document: CI_01EN

2. Indications for the cleaning agent

Neutral pH, enzymatic and alkaline (pH<11) cleaning agents are recommended and preferred for cleaning
SpineVision devices. Only agents whose efficacy has been proven (FDA cleared, EC marked, …) should be used. It is
important to select enzymatic solutions intended for breakdown of blood, body fluids and tissues which are suitable
for use with orthopaedic instruments.

SpineVision’s cleaning protocol has been validated using the cleaning agent: STERIS® PROLYSTICA - 2X Concentrate
Enzymatic Presoak and Cleaner, diluted in 1mL of 1L warm water (24°C).

Saline and cleaning/disinfection agents containing bleach, formaldehyde or sodium hydroxide (NaOH) can damage
specific components and should not be used.

As aldehydes may hold TSE agents steady, solutions containing aldehydes should not be used.

Cleaning agents should be prepared at the concentration and temperature recommended by the manufacturer.

If cleaning step is performed using an acidic or very alkaline agent, a neutralization step using a neutralizer has to be
performed immediately after the automatic cleaning cycle.

SpineVision devices are not normally used in surgical procedures where they contact low or high risk TSE
(Transmissible Spongiform Ence-phalophaties) infective tissue. Therefore decontamination procedures with highly
aggressive agents are not necessary and, for normal processing, are not recommended because material
degradation may occur.

When the instruments have been used in surgery with a risk of contamination by TSE agents (prions), a specific
cleaning procedure may be necessary.

For instruments used on patients with high risk of contamination by (TSE) agents (prions), saline and
cleaning/disinfection agents containing bleach, formaldehyde or sodium hydroxide (NaOH) can be used.

Page 8 of14
This confidential document is the property of SpineVision Do not duplicate without authorization from SpineVision.
Computer filename: CI_01EN.docx