Medisafe SI DIGITAL - Introduction

6
Intended Purpose and Performance
The Medisafe SI Digital Cannulated Instru-
ment Cleaner is principally intended to clean
hollow (Cannulated) instruments, surgical in-
struments, and associated products. This is
achieved through a combination of ultrasonic
activity and low-frequency pulsed uid re-cir-
culation (Cannulated Pulse Enhancement) to
dislodge and ush away unwanted debris from
both the outside and the inside (hollow instru-
ments only) of items placed in the wash tank.
Washing is achieved using a unique, specially
formulated and clinically validated decontami-
nation uid (3E-Zyme) which is introduced into
the cycle before the cycle is commenced.
The Medisafe SI Digital Cannulated Instrument
Cleaner has been designed to perform within
strict and carefully controlled tolerances.
A stringent quality control programme ensures
that every unit is manufactured and tested
under controlled conditions to ensure that all
units perform identically.
Declaration of Conformity:
The Medisafe SI Digital Cannulated Instrument
Cleaner is designed and manufactured in the
UK by Medisafe UK Ltd. and complies with the
essential requirements of the Medical Devices
Directive 93/42/EEC (where appropriate).
Section 1-3 - Introduction User Manual
Ref: UM SI Digital I 6 07/08 Rev.A
Service Contracts and Extended Warranty
Packages:
Your Medisafe SI SI Digital Cannulated Instru-
ment Cleaner is supplied with a conditional 12
month parts and labour warranty (see Section
1-9) which is effective from the date of instal-
lation or three months from date of delivery
which ever is sooner.
Medisafe offer a range of Service Contracts
and Extended Warranty Packages which pro-
vide continued maintenance and breakdown
cover once the original warranty has expired.
Validation Option:
Medisafe can also provide a Validation service
which addresses the essential requirements
of HTM2030. The work will be performed by
an authorised Medisafe engineer and will en-
sure that your SI-SA Cannulated Instrument
Cleaner continues to perform within HTM2030
guidelines.