2
Section Title Page
1
1-1
1-2
1-3
1-4
1-5
1-6
1-7
1-8
1-9
Operation
Memorandum of Registration
Important Information
Introduction
Identifying Controls
Operating Instructions
Operating a Wash Cycle
Advance Functions
Routine Checks
Warranty
4
5
6
7
8
9
10
11
13
2
2-1
2-2
2-3
2-4
2-5
2-6
2-7
2-8
2-9
Installation
Unpacking
Technical Specication
Chemical Data
Dimensions
Installation
Operating Process
Troubleshooting Guide
Service Record
Decontamination Certicate
15
16
17
19
20
21
22
24
25
Contents User Manual
Ref: UM SI Digital TOC 2 07/08 Rev.A
Ref: UM SI Digital MOR 4 07/08 Rev.A 4
THIS MANUAL IS VALID ONLY FOR MEDISAFE SI DIGITAL CANNULATED INSTRUMENT
CLEANERS MANUFACTURED AFTER APRIL 1ST 2003 (SERIAL NUMBERS COMMENCING
0403).
Note to Person Installing this Product
This Memorandum of Registration MUST be completed by the person undertaking installation and
witnessed by the owner of the product.
Note to Owner of this Product
Be sure that this Memorandum of Registration is completed by the person undertaking to install
the product. In the event of a Warranty Claim the information contained within this Registration is
your evidence that the product has been correctly installed.
Important Note:
Failure to provide this evidence in the event of a warranty claim may result in the claim being
rejected (this does not affect your statutory rights as a customer).
Owner’s Name:
Installation Address:
Installation Date:
Serial Number:
(The model and serial number are located on the silver label to the rear of the unit)
Software Version:
(The software version of the unit can be viewed on the Front Panel LED Display for a 5 second period when
the unit is rst switched on)
Installed by:
Witnessed by:
Service and Maintenance Requirements:
The Medisafe SI Digital Cannulated Instrument Cleaner should be serviced on a regular basis
to ensure that the product continues to perform in accordance with its design parameters. See
Section 2-8: Service Record (page 24) for further information.
Section 1-1 - Memorandum of Registration User Manual
5
Section 1-2 - Important Information User Manual
Ref: UM SI Digital II 5 07/08 Rev.A
Electrical
The power cord and connector supplied with
this machine are wired according to the follow-
ing colour code:
240V 110V
Live BROWN BLACK
Neutral BLUE WHITE
Earth GREEN/YELLOW
If the supplied connector is removed, be sure
to observe the colour code when reconnecting
to an appropriate plug or fused spur.
For details of fuse replacement refer to
Section 1-8: Routine Checks.
Important Note:
To prevent re or shock hazard, do not
expose the unit to rain or moisture.
Dangerously high voltages are present
inside the unit. Do not open the cabinet.
Refer servicing and repair to qualied
personnel only.
Installation and Maintenance:
Observe the Routine Checks (Section 1-8),
Installation Instructions (Section 2-5) and the
Servicing requirements (Section 2-8) outlined
within this manual.
Intended Purpose:
The product is designed to be used in conjunc-
tion with pH neutral aqueous cleaning uids.
It should not be used ammable materials or
gases and should not be used for any purpose
other than that dened by the manufacturer
as the Intended Purpose (Section 1-3).
Warning:
If the equipment is used in a manner not
specied by the manufacturer, the protection
provided by the equipment may be impaired.
Chemicals:
This product contains a heating device and
the use of substances or chemicals other than
those specied may be hazardous. Never use
toxic, corrosive, or ammable liquids.
Read the Chemical Safety Information in
Section 2-3 of this manual before use.
Note:
Using non-approved chemicals may cause
damage to the machine and could void
both your warranty and your guarantee of
performance.
Heat:
The temperature within the unit can reach
65oC or more during and after operation. Take
care when removing items on completion of a
cycle and allow good time for the items to cool
to a safe temperature before handling.
Decontamination:
This product MUST be decontaminated in
accordance with local regulations before
transporting. In the event that the product
must be returned to the supplier, it is vital that
the Decontamination Certicate (Section 2-9)
of this manual is completed and returned with
the product.
Manufacturer Information:
Medisafe UK Ltd
The Snap Factory
Twyford Road
Bishop’s Stortford
Hertfordshire
CM23 3LJ
England
Telephone: +44 (0) 1279 461641
Fax: +44 (0) 1279 461643
E-mail: [email protected]
Web: www.medisafe.uk.com
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.
8
Loading a Basket in Preparation for a
Wash Cycle
Up to 6 hollow (cannulated) instruments may
be connected to the irrigation system using a
suitable combination of tubes and connectors.
The 6 irrigation ports (Right) will automatical-
ly ush liquid through the instruments when
the quick connect male tting on the end of
the hose and Luer assembly is pushed into
the manifold port on the basket (shown to the
right).
The connector on the hose and Luer assembly
should be tted to a suitable port on the in-
strument to be cleaned, or by using a correctly
sized Distal Connector.
Hollow (cannulated) Instruments
1. Connect a hose and Luer assembly to the
ush port on a cannulated instrument using
either a Luer lock connector or a suitably
sized Distal Connector
2. Ensure that all instrument taps are in the
open position and carefully position instru-
ments within the basket using the instru-
ment organiser supplied
3. Connect open end of hose and Luer assem-
bly to the manifold ports in the side of the
basket. Apply rm pressure and push the
connectors straight into the ports
4. Lower the basket into the wash tank and
connect to the irrigation port on the bottom
of the wash tank (see image on top right).
Apply rm pressure and push the connector
straight into the port
Surgical Instruments and Accessories
Position items within basket according to the
recommendations shown opposite.
Section 1-5 - Operating Instructions User Manual
Ref: UM SI Digital OI 8 07/08 Rev.A
Basket showing manifold ports and wash
tank connection port
Important Information on Loading
Instruments
When loading instruments into the basket be
sure to observe the following precautions:
Do not drop items into the empty wash tank as this
could damage the ultrasonic transducers.
Do not place items to be cleaned directly into the
wash tank or allow them to make contact with the
sides of the tank.
Do not load the basket with instruments pointing at
the lid or the level sensors.
Do not overload the basket.
Always attach tubing to a Distal Connector of
suitable size for the instrument being cleaned or to
a quick connect port if the instrument has one.
Always open box jointed instruments.
Always ensure that taps on cannulated instruments
are open.
Always disassemble instruments which are
designed to be taken apart
Always connect instruments of similar bore size to
the same manifold.
Always attach Luer pipes to manifolds if cannulated
instruments are not being cleaned as this will aid
water circulation.
Before Operating a Wash Cycle
• Ensure that a new
drain lter is tted
into the drain at
the bottom of the
wash tank.
• Ensure that a
correctly loaded
basket is in the
wash tank and that the basket hose is
connected to the
port on the bottom
of the wash tank
(refer to page 8).
• Ensure that the
drain tap is in
the fully closed
Position.
Operating a Wash Cycle
1. Fill the wash tank to the full mark with water
at 40OC.
2. Add 3E-Zyme detergent in the ratio of
7ml/3E-Zyme per litre/water.
3. Connect the unit to the mains supply and
switch on.
4. Check that the LED display on the front
panel is indicating ‘ -- ‘ and press the ‘On’
key once.
The LED display will now indicate the
default time of the intended wash cycle
and the yellow ‘Heater’ enable led will be
illuminated.
5. Close lid and press the ‘START’ key once to
commence the cycle.
The green ‘Process’ led will be lit, a light
will ash on the LED display, and the time
remaining until the end of the wash cycle
will be indicated.
9
Section 1-6 - Operating a Wash Cycle User Manual
Ref: UM SI Digital OI 9 07/08 Rev.A
(the countdown process will continue even
if the LED display is ashing or the display
has been changed to Temperature).
At the End of the Wash Cycle
Once the cycle has completed the LED display
will return to the default cycle time of 15
minutes (see page 10).
The lid may now be opened and the contents
of the wash tank removed.
Pausing a Wash Cycle
If it is necessary to pause a cycle whilst in
progress, press the ‘START’ key once.
Press the ‘START’ key again to resume the
cycle.
Changing the Wash Cycle Time
The wash cycle time may be changed before or
during a cycle in the following way:
• To increase the cycle time, press and hold
the ‘Plus’ key until the required time is
displayed.
• To decrease the cycle time, press and hold
the ‘Minus’ key until the required time is
displayed.
Note:
Changing the time in this way affects ONLY
the current wash cycle. To amend the default
time, refer to page 8.
Note:
To get the best performance from this cleaner
the rst cycle after lling with fresh water
should be run with no instruments, This is
known as the de-gas cycle and removes
dissolved gasses from the water.
10
Section 1-7 - Advanced Functions User Manual
Ref: UM SI Digital AF 10 07/08 Rev.A
Disabling Heaters
Should it be necessary to disable the wash tank
heaters for any reason, observe the following
procedure:
From stand-by mode, press ‘Temperature’
key once.
‘Temperature’ LED will light and temperature
will be displayed in steady text.
Press ‘Start’ key once and ‘Heater’ LED will
be extinguished, indicating that heaters are
now disabled.
Press ‘Start’ key once to re-enable.
Changing Default Values
The Medisafe Digital Cannulated Instrument
Cleaner has factory set default values for wash
time and temperature. These settings may
be changed as required using the front panel
controls.
The default settings (shown below) have been
selected to enable the Medisafe SI Digital
Cannulated Instrument Cleaner to comply with
the guidelines recommended in HTM2030.
The settings represent those which provide
optimum cleaning efciency and Medisafe (UK)
Ltd. can accept no responsibility regarding
adverse cleaning performance if the factory
values are changed.
Factory default values:
Wash Duration: 15 minutes
Wash Temperature: 40OC
Beware:
The performance of this product is validated
at the time of installation using ONLY these
default settings.
Changing Default Wash Time
To change default wash time, observe the
following procedure:
1. From stand-by mode, press ‘On’ key once.
2. ‘Time’ LED will light and time will be
displayed in ashing text.
3. Press ‘Plus’ key to increase cycle time.
4. Press ‘Minus’ key to decrease cycle time.
5. Press ‘On’ key once to return to stand-by
mode.
6. Press ‘On’ key once, new default time will
be displayed in steady text.
Changing Default Wash Temperature
To change default wash temperature, observe
the following procedure:
1. From stand-by mode, press ‘Temperature’
key once.
2. ‘Temperature’ LED will light and
temperature will be displayed in steady
text.
3. Press ‘Temperature’ key and temperature
will be displayed in ashing text.
4. Press ‘Plus’ key to increase temperature.
5. Press ‘Minus’ key to decrease
temperature.
6. Press ‘Temperature’ key once.
7. Revised default temperature setting will be
displayed in steady text.
11
To ensure that your Medisafe SI Digital
Cannulated Instrument Cleaner continues
to operate within it’s design parameters it is
recommended that the following checks are
performed on a regular basis. Consulting the
Troubleshooting guide in Section 2-7 of this
manual may prove useful when conducting the
checks.
Please Note:
That completion of these checks is not
a substitute for regular servicing and
maintenance by a suitably qualied engineer.
Before every rell
Perform the following procedure after empting
the tank:
• Replace drain lter in wash tank
Carefully remove the small, caged lter
located in the drain inside the wash
tank. Replace with a new item.
• Wipe water level sensor in tank
Carefully wipe any excess moisture or
dirt from the water level sensor using
a lint free cloth, soft brush or alcohol
swab.
Section 1-8 - Routine Checks User Manual
Ref: UM SI Digital RC 11 07/08 Rev.A
• Drain wash tank in the following
way:
Connect hose to drain tap and place
other end into a suitable drain
Open tap on drain valve.
Press and hold the ‘speed drain’ button
on front, right-hand side of the unit
until wash tank is empty.
Daily Checks
The following checks should be performed
daily.
• Check cleanliness of all external
surfaces.
The outside of the unit may be cleaned
by wiping with a decontaminant wash.
• Check lid and lid seal.
Inspect the lid seal for any signs of
damage.
The lid seal may be cleaned in the same
way as the external surfaces.
Take care not to damage the seal dur-
ing cleaning.
Ensure that lid can be opened and
closed without restriction.
• Check that the wash tank is clean
and free from any deposits.
The wash tank may be cleaned by wip-
ing with a decontaminant wash or suit-
able disinfectant.
• Check condition of hose connect-
ing basket to port in wash tank.
Ensure that hose is not kinked or
ruptured.
12
Weekly Checks
The following checks should be performed
every week:
• Check cleaning efciency of unit.
Place 5 TOSI (or Sonocheck) test strips in
the wash basket in the following positions.
Secure in place using an appropriate
method, i.e., nylon cable ties.
Run a wash cycle (refer to page 9).
Check that test strip is completely cleaned
with no red or clear residue remaining and
the Sonocheck has changed colour.
• Check mains power cord.
Ensure that the mains power cord is not
trapped or damaged.
Check that connector to the mains supply
is secure.
Section 1-10 - Routine Checks User Manual
Ref: UM SI Digital RC 12 07/08 Rev.A
Fuse Replacement
If the unit should stop working for any reason
consult the troubleshooting guide in Section
2-7. If a fuse replacement is necessary then
proceed in the following way:
Warning:
Isolate unit from mains supply before
attempting to replace fuses.
1. Ensure that power supply to unit is
disconnected
2. Using a screwdriver, push the cen-
tre section inwards whilst turning an-
ti-clockwise
3. Remove centre section complete with fuse
4. Replacement is a reversal of the above
procedure
Tosi strips basket
Replace fuses with same type
13
PRODUCT WARRANTY
To ensure continued efciency and long operational life,
your new Instrument Cleaner is covered by a one year
warranty which is arranged and administered by Medisafe
(UK) Ltd. Details of the warranty are explained in this
section.
Subject to the following terms and conditions, Medisafe
(UK) Ltd. warrants that any item of THE BASIC WARRANTY
ITEMS of the unit (hereinafter called ‘new Instrument
Cleaner’) manufactured by Medisafe (UK) Ltd. shall be
free from any defects in material and workmanship under
normal use and maintenance.
Any item of THE BASIC WARRANTY ITEMS covered by the
limited warranty will be repaired or replaced free of charge
by Medisafe (UK) Ltd. or any distributor authorised by
Medisafe (UK) Ltd. to act as their agent (hereinafter called
‘authorised Medisafe dealer or distributor’).
THE BASIC WARRANTY ITEMS
THE BASIC WARRANTY ITEMS are any items (except
THE SPECIFIC EXCLUDED ITEMS) of this new Instrument
Cleaner which are warranted by an authorised Medisafe
dealer or distributor within 12 months of the WARRANTY
START DATE when this new Instrument Cleaner is rst
installed by or for you (the original purchaser) as set forth
on the Memorandum of Registration.
THE BASIC WARRANTY ITEMS listed below are warranted
within 12 months of the WARRANTY START DATE against
defects in manufacture.
- solenoid valves
- electric motors and pumps
- switches
- electronic control circuits
- water heating elements
- ultrasonic transducers
THE SPECIFIC EXCLUDED ITEMS
THE SPECIFIC EXCLUDED ITEMS are any items of this new
Instrument Cleaner which are not included in THE BASIC
WARRANTY ITEMS and are therefore not subject to the
terms and conditions of the PRODUCT WARRANTY.
Expendable items which will deteriorate and require
replacement with normal use of the new Instrument
Cleaner (for example: lid seal, water inlet lter element,
various types of gaskets and hoses, lamp bulbs (if tted),
and other expendable parts not specically listed)
Section 1-11 - Warranty User Manual
Ref: UM SI Digital W 13 07/08 Rev.A
Fair wear and tear of any part, normal maintenance service
items, and the parts and any material used in connection
with the new Instrument Cleaner.
Normal deterioration or damage to plated parts, paint
coat, and rubber parts caused by daily wear and exposure
to atmosphere and environment.
Minor irregularities not affecting quality, performance
or function of the new Instrument Cleaner parts thereof
(e.g. slight noise or vibration) or which appear only under
particular abnormal conditions.
Damage caused by insufcient or improper maintenance
(e.g. negligence of the daily, weekly, and monthly periodic
inspections and any servicing requirements as described
and specied within this manual).
Damage caused by using a part or lubricants not approved
by an authorised Medisafe dealer or distributor or being
repaired or replaced by a person who is not an authorised
Medisafe dealer or distributor.
Damage caused by accident, abuse, or negligence of the
proper handling as set out in this Owner’s Manual, misuse
of the new Instrument Cleaner, use of the new Instrument
Cleaner under unusual conditions, and modications of or
to the new Sonic Irrigator or any component/parts thereof
not recommended or approved by an authorised Medisafe
dealer or distributor.
Damage caused by external inuences such as chemical
spillage, accident, re, and disasters due to human fault
or negligence or Act of God.
Damage to the external casing, wash chamber, load
carriers, or any part of the new Instrument Cleaner
which may come into contact with the load carrier during
the process of loading/unloading the new Instrument
Cleaner.
All charges incidental to breakdowns, such as loss
of use of the new Instrument Cleaner, loss of time,
inconvenience, telephone, transportation, loss or damage
to personal property or loss of revenues, or other matter
not specically included.
Damage caused by incorrect installation of the new
Instrument Cleaner which could cause operational failure or
impairment either immediately after such installation or at
any time within the period of this PRODUCT WARRANTY.
Medisafe (UK) Ltd. reserves the right of nal decision on
all manufacturers’ warranty claims.
Nothing herein affects the statutory rights of a
consumer.
15
Unpacking
Carefully unpack your Medisafe SI Digital Can-
nulated Instrument Cleaner and retain the
carton and all packaging materials. If the unit
needs to be returned to the supplier for any
reason then the original carton and packaging
materials should be re-used **
The unit is supplied with a range of accessories
to enable easy installation and efcient opera-
tion. Ensure that all these items are present
before attempting to install or operate the
unit. Complete the following Enclosures Check
List and notify your supplier of any shortages
or damaged components as soon as possible.
Enclosures Check List
• 1 Grey drain hose
• 1 Instrument organiser (Pk 2)
• 1 Sample bottle 3E-Zyme
• 1 Instrument basket
• 1 Owner’s Manual
1 Plumbing kit comprising:
• 12 short hose and leur assys
• 1 long hose and leur assy
• 6 small nozzles
• 6 ‘Y’ connectors
• 1 drain hose adaptor
• 24 lters
• 6 Assorted distal connectors
Section 2-1 - Unpacking User Manual
Ref: UM SI Digital U 15 07/08 Rev.A
Replacement Parts and Consumables
A range of replacement parts and consumable
items approved by Medisafe for use with the
SI Digital Cannulated Instrument Cleaner may
be purchased from your supplier. The use of
these compatible Medisafe approved products
will ensure the continued and reliable opera-
tion of your washer.
Additional detergent (3E-Zyme) may be
purchased from your supplier using the
following order code:
3E-Zyme Detergent
(1 x 4 litre bottle)
Pt # MED8035
Filters
Pack 24
Pt # MED3079
Warning:
Using non-approved chemicals, accessories,
and replacement parts may cause damage
to the machine and could void both your
warranty and your guarantee of performance.
** Before transporting a used Medisafe
SI Digital Cannulated Instrument Clean-
er it is vital that all uids are thoroughly
drained. If the unit is being returned to
your supplier or Medisafe UK Ltd. then
the Decontamination Certicate MUST
be completed and returned with the
unit. The Certicate can be found in Section
2-9 (page 25) of this manual.
16
General:
Medisafe Part No: MED 1130 230V 50Hz
MED 1130.1 120V 60Hz
MED 1130.2 230V 60Hz
Model: Medisafe SI Digital
Cannulated Instrument
Cleaner
Description: Medical Device Class I
Intended Purpose: Internal and external
cleaning of surgical
instruments, hollow-ware,
and associated products
Operating Process: Ultrasonic activity
Applied Standards:
BS2745: part 1: 1993
BS2745: part 3: 1993
EN60101-1:2001 (2nd Edition)
EN61010-2-045 (2001)
EN61326: 1997
A1: 1998
EN980
Wash Cycle Parameters:
Min. Temp. During Cycle: Determined by
temperature
setting of user
(max 60OC)
Max. Temp. During Cycle: Determined by
temperature
setting of user
(max 60OC)
and time sonics
are ON
Vol. of Dispensed Chemicals: Not applicable
Required Services:
Electricity Supply:
Supply Voltage: single phase 230V
nominal (+/- 10%)
50 or 60Hz
110 – 127V 60Hz
NOT USER SELECTABLE
Power Consumption: 900Va max.
(operational mode)
0.5Va max.
(stand-by mode)
Termination: 3 pin earthed plug
Lead Length: 1.83m (6 feet)
Method of disconnect: Remove mains plug
Section 2-2 - Technical Specication User Manual
Ref: UM SI Digital TS 16 07/08 Rev.A
Water Supply:
Manual lling from nearby supply, Hot and
cold or mixed supply at 40OC.
Drain:
Connection on product: 20mm outside
dia unthreaded
Service connection: Nearby sink or
11/2” dia drain
tted with
suitable trap
Discharge Orice Type: 18mm outside
dia. unthreaded
hose tail
Max. Flow to Drain: 10 litres/min
Max. Temp. of Efuent: As per user set
temperature
Ventilation:
Max. Heat Output of Load: As per user set
temperature
Chemicals:
Size and Nature of Containers:
3E-Zyme Fluid: 4 litre plastic bottle
Storage Instructions:
3E-Zyme Fluid: Refer to Section 2-3:
Chemical Data
Safe Handling Instructions:
3E-Zyme Fluid: Refer to Section 2-3:
Chemical Data
Quantity Used per Cycle:
3E-Zyme Fluid: 160ml (approx)
Weight:
Operational weight: 51kgs
Shipping weight: 41kgs
Dimensions:
Wash Chamber Volume: 26,000 cm3
Outer Cabinet Dimensions: 715 mm (w)
445 mm (d)
335 mm (h)
Carton Dimensions: 950 mm (w)
600 mm (d)
480 mm (h)
Installed Clearances: See section 2-5
Warning:
Dangerously high voltages are present inside the
unit. Do not open the cabinet. Refer servicing and
repair to qualied personnel only.
17
Section 2-3 - Chemical Data User Manual
Ref: UM SI Digital CD 17 07/08 Rev.A
This document conforms with Regulation 6 of
the Chemicals (Hazardous Information and
Packaging for supply) Regulations 1994
(CHIP 2) - Second Edition
Revision No: M089/01
Date of Publication: 16/01/01
Product: 3E-Zyme®
1. IDENTIFICATION OF THE PRODUCT
AND COMPANY
1.1 Trade Name: 3E-ZYME®
1.2 Type of product: Triple enzyme
cleaner
1.3 Manufacturer/Supplier: Medisafe UK Ltd
1.4 Marketing Address: The Snap Factory
Twyford Road
Bishop’s Stortford
Hertfordshire
CM23 3LJ
United Kingdom
1.5 Manufacturing Address: as above
2. COMPOSITION/INFORMATION ON
INGREDIENTS
2.1 Chemical type: Triple Enzyme
Solution
2.2 Major ingredients:
Mixed Enzyme Solution <5%
Isoproponol <15%
Monopropylene Glycol <15%
Demineralised water, solubilisers - balance
3. HAZARDS IDENTIFICATION
No specic hazards
4. FIRST-AID MEASURES
(Must be taken immediately)
4.1 Inhalation:
Non-toxic: avoid long term inhalation of neat liquid.
Remove to fresh air.
4.2 Eye contact:
Rinse eyes copiously with water for 10 minutes.
Seek medical advice as necessary.
4.3 Skin contact:
Wash affected area with soap and water.
Avoid prolonged contact.
4.4 Ingestion:
Do not induce vomiting. Give milk or water to drink.
Seek medical advice where necessary.
5. FIRE-FIGHTING MEASURES
(Non ammable solution)
5.1 Extinguishing media: Any available
means
5.2 Explosive quality: Nil
5.3 Specic hazard: No specic hazard
5.4 Specic protective measures: Not
required
6. ACCIDENTAL RELEASE MEASURES
6.1 Environmental precautions:
Product is biodegradable under OECD conditions
operational 6/1995.
6.2 Clean up method:
Flush to drain with copious water or soak up onto
inert material and dispose of with clinical waste
6.3 Clothing for disposal:
Wear gloves and apron, avoid prolonged skin
contact
7. HANDLING AND STORAGE
7.1 Handling guidelines:
Safe handling by trained professional staff in
accordance with label instructions only. Not to be
mixed with other chemicals. Keep from children.
7.2 Storage guidelines:
Store in dry place not below 0oC. or above 30oC.
and out of direct sunlight. Keep lidded. Keep from
foodstuffs and drinks.
18
Section 2-3 - Chemical Data User Manual
Ref: UM SI Digital CD 18 07/08 Rev.A
11. TOXICOLOGICAL INFORMATION
11.1 No specic data on le
12. ECOLOGICAL INFORMATION
12.1 No known adverse effects from normal use
13. DISPOSAL CONSIDERATIONS
13.1 Packaging:
Can be disposed of as normal waste in
accordance with local authority regulations
13.2 Contaminated Packaging:
May be disposed of safely under normal
conditions in accordance with local
authority regulations
13.3 Product:
Solution to be disposed of in accordance
with spillage instructions as detailed in
Section 6 within the Section
Chemical Data.
14. TRANSPORT INFORMATION
14.1 No special conditions apply.
Not dangerous.
15. REGULATORY INFORMATION
Not a licensed medicine
16. OTHER INFORMATION
SAFETY PHRASES
(2) Keep out of reach of children
(24/25) Avoid contact with the skin and
eyes
(50) Do not mix with other chemicals
8. EXPOSURE CONTROLS/PERSONAL
PROTECTION
8.1 Personal protection:
Use with care, avoid eye contact and
prolonged skin contact. Gloves and safety
glasses recommended if available.
External use only. Not for ingestion.
8.2 Skin contact:
Low risk: may degrease skin leading to
dryness if excessive contact
8.3 Eye contact:
Low risk: may cause temporary discomfort
8.4 Inhalation:
Low risk: no known hazard
8.5 Inhalation (long term):
Low risk: no known hazard
8.6 Ingestion:
Low risk: substantial ingestion will cause
discomfort to mouth and digestive tissues
9. PHYSICAL AND CHEMICAL
PROPERTIES
9.1 Physical State: Liquid
9.2 Appearance & Odour: Blue with neutral
fragrance
9.3 Evaporation Rate: As water
9.4 Boiling Point: 110OC
9.5 Freezing Point: -20OC
9.6 % Volatile (by weight): >95%
9.7 Solubility in Water (20 oC): Soluble
9.8 pH: 7.5 approximately
9.9 Specic Gravity: 1.01 @ 20OC
10. STABILITY AND REACTIVITY
10.1 No decomposition if stored and used as
directed
10.2 Hazardous decomposition products: none
under normal use
20
Section 2-5 - Installation User Manual
Ref: UM SI Digital I 20 07/08 Rev.A
Connecting the Medisafe SI Digital
Cannulated Instrument Cleaner:
1. Unpack the machine and place it on a sturdy,
level surface. The unit should be positioned
within 1.83m of a 13A mains supply and, if
possible, a suitable drain and hot and cold
water supplies.
2. Remove any protective packaging and loose
items from inside the wash tank.
3. Identify the grey plastic, convoluted DRAIN
HOSE supplied with the unit. The smallest
end of the hose should be connected to the
drain tap at the lower front, right hand side
of the unit using the adaptor supplied. The
larger end should be connected to a suitable
drain which is below the level of the drain
outlet on the unit.
4. Open the bag containing the basket and
plumbing kit. Connect one end of the basket
connecting hose to the port located in the
bottom of the wash tank. Connect the other
end to the port on the manifold tted to the
side of the basket.
5. Remove the drain lter from the packaging
and insert into the drain orice at the bottom
of the wash tank.
6. Plug the 3 pin mains plug into a suitable
switched outlet and switch on.
Note:
The mains plug is the disconnect method for
the mains supply to the unit and should be
readily accessible at all times.
Your Medisafe SI Digital Cannulated
Instrument Cleaner is now ready for use
Attach DRAIN HOSE here
Main power cord
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