Niagara Express

User Manual

Medisafe International, Twyford Road, Bishop’s Stortford, Hertfordshire CM23 3LJ, U.K. T: +44 (0)1279 461641 F: +44 (0)1279 461643
www.medisafeinternational.com E:info@medisafeinternational.com
Table of Contents User Manual

Section Title Page

1 Introduction 4

1-1 Introduction 5

1-2 Note 6

1-3 Warranty Registration 7

1-4 User Training 9

1-5 Product Identity 11

1-6 Intended purpose & Performance 12

2 Installation 14

2-1 Installation Requirements 14

2-2 Niagara Dimensions 15

2-3 Connecting to Data Logging PC 16

3 Operation 17

3-1 Dirty Side Controls 18

3-2 Clean Side Controls 19

3-3 Niagara Trolley 20

3-4 Loading Carrier 21

3-5 Chemical Handling & Replacement 22

3-6 Operating a Wash Cycle 23

3-7 Aborting a Wash Cycle 30

3-8 Error during a Wash Cycle 32

3-9 Important Information on Loading 33

express
Ref: NIAGARA Express UM 2 05/15 Rev.G 2
Table of Contents User Manual

Section Title Page

4 Technical 34

4-1 Technical Specifications 35

4-2 Niagara Program Parameter 37

4-3 Process Monitoring 38

4-4 Routine Checks 39

4-5 Troubleshooting Guide 40

4-6 Failure Mode Access 41

4-7 Warranty 42

4-8 Service Record 44

4-9 Decontamination Guide 45

4-10 Decontamination Certificate 46

express
Ref: NIAGARA Express UM 3 05/15 Rev.G 3
 1.Introduction
Niagara Express

express
Ref: NIAGARA Express UM 4 05/15 Rev.G 4
Section 1-1 - Introduction User Manual

Introduction

Compliance

The Niagara Express has been designed to perform within the guidelines recommended by
international decontamination Standards. A stringent quality control programme ensures that every unit is
manufactured and tested under controlled conditions to ensure that all products perform identically.

Declaration of CE Conformity

The Niagara Express 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). All products are CE
compliant and are registered as Class IIa devices through the application of all 18 rules within Annex IX of
the Medical Devices Directive 93/42/EEC.

Manufacturer Information:

Medisafe UK Ltd
The Snap Factory
Twyford Road
Bishop’s Stortford
Hertfordshire
CM23 3LJ
England
T: +44 (0) 1279 461641
F: +44 (0) 1279 461643
E: info@medisafe.uk.com

express
Ref: NIAGARA Express UM 5 05/15 Rev.G 5
Section 1-2 - Note User Manual

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:

Software Version:

Installed by:

Witnessed by:

express
Ref: NIAGARA Express UM 6 05/15 Rev.G 6
Section 1-3 - Warranty Registration User Manual

express
Warranty registration

Site:

Department:

Address:

Machine Serial number:

Date:

Name:

Position:

Telephone:

E-mail:

express
Ref: NIAGARA Express UM 7 05/15 Rev.G 7
Section 1-3 - Warranty Registration User Manual

Part 1, Test Type Acceptable

Result Comments
Value

Drains remove effluent effectively;              

The exhaust ventilation/ condenser is adequate;
Phase sequence, Pump Rotation;      
Supports bases secure;
There is no evidence of interference to or from
other equipment connected to the same services;
Operation of the emergency stop buttons;
Hot Water Hardness (As specified by WD
125ppm max ppm
Manufacturer)
Cold Water Hardness (As specified by WD
125ppm max ppm
Manufacturer)
Hot Water 60°C min °C
Cold Water Temperature 30°C max °C
Hot Water Pressure 2-5 bar bar
Cold 2-5 bar bar

Part 2, Final rinse water Acceptable

Result Comments
Value

Disinfection water supply. Type. RO, DI, softened:

Water Hardness (As specified by WD
125ppm max ppm
Manufacturer)
Water Pressure: 2-5 bar bar
Temperature: °C
<30uS/cm RO
<10uS/cm DI
Electrical conductivity:
<300uS/cm
Softened

This Document must be completed by the engineer commissioning the Niagara for warranty registration
purposes. Parts one and two must be fully completed. Where no value is required write pass or fail with
a comment if necessary,
A copy of this form has to be faxed to the number below to validate warranty. Fax: +44 1279 461643

Signed:........................................., Name:........................................., Date:..............................

Comments / remedial work:........................................................................................................

...............................................................................................................................................
...............................................................................................................................................
...............................................................................................................................................
...............................................................................................................................................

express
Ref: NIAGARA Express UM 8 05/15 Rev.G 8
Section 1-4 - User Training User Manual

The owner of this equipment has the responsibility for giving training and keeping records of training to the user.
Please follow the table below to for user training contents.

No. Description/Task Please Tick [ √ ]

1. Switch on of the machine [ ]

2. Emergency Stop buttons location and operation [ ]

3. Emergency Stop buttons unlocking [ ]

4. Touch screen operation [ ]

5. Niagara set Time and Date screen purpose [ ]

6. Niagara Main screen buttons [ ]

7. Login operation and user groups (Administrator, Engineer, Operator) [ ]

8. Log off operation [ ]

9. Hazardous liquids handling – safety instructions [ ]

10. Chemical drawer position and operation [ ]

11. Chemical bottle replacement [ ]

12. Chemical priming screen – pump priming process explanation [ ]

13. Back button operation on the screen [ ]

14. Niagara Programs - explanation [ ]

15. Safety instruction for door operation – safety edge protection [ ]

16. On screen chemical level check [ ]

17. Pre-Cycle check Fail/Pass criterion [ ]

18. Instruments arrangement in the carrier [ ]

19. Irrigation connectors operation – push on fittings and luer connectors [ ]

20. Proper carrier loading – explanation of most common techniques [ ]

21. Level removal from variable carriers [ ]

express
Ref: NIAGARA Express UM 9 05/15 Rev.G 9
Section 1-4 - User Training User Manual

No. Description/Task Please Tick [ √ ]

Anaesthesia carrier loading – instrument and accessories positioning, hose arrange-
22. [ ]
ment

23. Theatre shoes carrier loading – removal of the top level, shoe arrangement [ ]

Container carrier loading – orientation of containers, full/half din loading, loading of

24. [ ]
the container lids

25. Trolley – function (bottom level carrier storage), tray cleaning [ ]

26. Trolley docking against the machine – position, wheel lock [ ]

Machine loading operation – carrier position in the chamber and on screen indica-
27. [ ]
tion

28. Automatic carrier recognition/Manual carrier choice [ ]

29. Start of the cycle/confirmation screen. [ ]

30. Program screen – explanation [ ]

31. Cleaning process description – times and temperatures [ ]

32. Visual check of cleaning efficiency – blocked sprayarms [ ]

33. Drying – visual check of efficiency – fully open flaps and temperature. [ ]

34. Cycle finish – screen message, audible alarm, carrier position [ ]

35. Trolley position – wheel lock [ ]

36. Carrier unloading – high temperature warning, visual check of the load [ ]

Printout/program log check – program type and parameters, temperature, times, A0

37. [ ]
value, etc.

38. Clean side button – door open/close [ ]

39. Unloading finished confirmation on the screen – machine reset [ ]

40. Machine shut down function [ ]

Site Name:
Site Address:
Post Code:
Date:
Place of Training:
Trainee Name: Trainee Signature:
Trainer Name: Trainer Signature:

express
Ref: NIAGARA Express UM 10 05/15 Rev.G 10
Section 1-5 - Product Identity
Service and Maintenance Requirements:
The Medisafe Niagara Express should be
serviced on a regular basis to ensure that the
product continues to perform in accordance
with its design parameters. See appendix for
quarterly/annual and commissioning/validation
paperwork in service manual.
Product Identity
The model and serial number are located on a silver
label on the inside of the electrical box door. The
software version can be viewed on the Front Panel
LCD Display before the login screen.
Important Note:
Dangerously high voltages are present inside the
unit. Do not open the left cabinet. Refer servicing
and repair to qualified personnel only.
A fully qualified electrician should only connect this
version and as such no information is supplied in
this manual.
Ref: NIAGARA Express UM 11 05/15 Rev.G
User Manual
Installation and Maintenance
Intended Purpose:
The product is not suitable for use with flammable
materials or gases and should not be used for any
purpose other than that defined by the manufacturer
as the Intended Purpose.
Chemicals:
This product contains high power heating devices
and the use of substances or chemicals other than
those specified may be hazardous.
Read the chemical safety information in this manual
before use.
Heat:
The temperature within the unit can reach 95OC dur-
ing and after operation. Take care when opening the
lid, and on completion of a cycle. 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 Certificate in
this manual is completed and returned with the product.
Important Note:
Never use toxic, corrosive, or flammable liquids.
Using non-approved chemicals may cause damage
to the machine and could void both your warranty
and your guarantee of performance.
express
11
Section 1-6 - Intended Purpose & Performance User Manual

The Medisafe Niagara Express is principally intended to clean hollow (cannulated) in-
struments, surgical instruments, and associated products. This is achieved through a
combination of Rotating spray arms fed with high flow high pressure water, ultrasonics
and a irrigation action to remove debris from both the outside and the inside (hollow
instruments only) of items placed in the wash tank.

Washing is achieved using a unique, specially breakdown cover once the original warranty has
formulated and clinically validated decontamination expired.
fluid (3E-Zyme®) (alkaline), which is introduced into
the cycle during the programme. Validation Option:

The Niagara Express has six pre-programmed wash
cycles.
If a wash cycle fails to achieve any one of the
predetermined parameters then the system reports
a failed cycle. The unit registers such a failure and
brings it to the attention of the operator, who is then
unable to remove the load without being aware that
the cycle has been aborted.
Medisafe (UK) or its distributors can also provide a
Validation service, which addresses the essential
requirements of local regulations. The work will be
performed by an authorised Medisafe engineer and
will ensure that your Niagara continues to conform
to the relevant local and national guidelines.
For more information on any of these options please
contact your regional distributor or Medisafe UK.

The Medisafe Niagara Express has been designed Warning:

to perform within strict and carefully controlled toler- If the equipment is used in a manner not specified
ances. by the manufacturer, the protection provided by the
equipment may be impaired.
A stringent quality control programme ensures that
every unit is manufactured and tested under con-
trolled conditions to ensure that all units perform
identically.
Warning:
Declaration of Conformity: All personnel who operate or maintain the equip-
ment has to be trained in its operation and in its safe
The Medisafe Niagara Express is designed and use.
manufactured in the UK by Medisafe UK Ltd. and
complies with the essential requirements of the
Medical Devices Directive 93/42/EEC (where ap-
propriate).

Service Contracts and Extended Warranty Pack-

ages:

Your Medisafe Niagara Express is supplied with a

conditional 12-months warranty, which is effective
from the date of installation provided the registration
documents has been returned to Medisafe UK.
Medisafe (UK) or its distributors offer a range of
Service Contracts and Extended Warranty Pack-
ages which provide continued maintenance and

express
Ref: NIAGARA Express UM 12 05/15 Rev.G 12
 2.Installation
Niagara Express

express
Ref: NIAGARA Express UM 13 05/15 Rev.G 13
Section 2-1 - Installation Requirements User Manual

Water Supply:
RO water: 40 litres (10.6 US gallons)
Consumption per
Hot water: 80-105 litres (21.1-27.7 US gallons)
cycle1:
Cold water: 55-80 litres (14.5-21.1 US gallons)
12-30 litres per minute for hot & cold water
Flow Rate:
12 litres per minute for RO water (for disinfection tank)
Pressure: 2–5 bar (29-72.5psi) for RO, hot and cold water
RO water: > 30OC ( > 86OF)
Temperatures: Hot water: 60-90OC (140-194OF)
Cold water: < 30OC (< 86OF)
Water Hardness <150ppm with Water Quality and Purity tested and approved for Washing and Disinfection as per EN
Quality and Purity: ISO15883-1:2003 (item 6.4.1 and 6.4.2)
1x shut valve with ¾” BSP male thread for RO water (2x if RO water is used on rinse)
Connections : 2
1x shut valve with ¾” BSP male thread for hot water
1x shut valve with ¾” BSP male thread for cold water
Position: Flexible hose, up to 1 meter (3.28 feet) above or alternatively underneath3 the machine
Power Supply:
Voltage: 3N+PE 380 - 415V/50Hz or 60Hz
Niagara Standard: Supply with maximum consumption of 21kWH4, Fused 3x63A on the building Side
Power
Steam Heated with Electrical Drying : Supply with maximum consumption of 10KWH,
Consumption:
Fused 3 x 32A on building side
Connection and Cables connected from the top of the machine (Power cable required diameter is 13mm - 18mm).
Isolator position: Please position Mains Isolator device near the equipment, and ensure easy accessibility to it.
Compressed Air Supply:
Pressure: 5.5 - 7.0 bar (79.77-101.52 psi)
Quality: If compressed air is not of Medical Grade, An Eliminizer has to be included at the time of order
Connection: 8mm (0.314 inches) OD hose supplied either from ceiling or below the machine
Air Exhaust:
Connection: 90mm ID (3.54 inches)
Drainage System:
Connection: 60.3mm (2.37 inches) OD pipe at the bottom of the machine5

Drainage Capacity 180 Litres (47.6 US gallons)/minute at maximum temperature of 95OC (203OF)
and Type:
Gravity Drain
Heat Output:
15.5k BTU/hour - During Operation
Heat output in BTU:
3.8k BTU/hour – During Standby
3900 kcal/hour - During Operation
Heat output in Cal:
960 kcal/hour – During Standby
Steam Supply ( Steam heated with Electrical Drying)
Mass Flow 26.4Kg/hour
Pressure: 2 Bar
Ref: NIAGARA Inst.Req 380-415V 01/10 Rev.J

Temperature: 185 oC
Connection: 1” BSP

(1) Consumption vary depending on the type of the cycle, (2) For position of the shut valves refer to the installation drawing, (3) Longer set of hoses will need to be

ordered separately, (4) Power consumption strongly depends on the volume and thermal efficiency of the water supply system, (5) For position of the drain refer to the

installation drawing

Please Note: The electrical box temperature should not exceed 55 oC to ensure proper operation of Electrical & Electronic components.

express
Ref: NIAGARA Express UM 14 05/15 Rev.G 14
Section 2-2 - Niagara Dimensions User Manual

124

131 Steam Connection

express
Ref: NIAGARA Express UM 15 05/15 Rev.G 15
Section 2-3 - Connecting to Data Logging PC User Manual

The Niagara Express transmits data of a wash cycle from

the serial port at a speed 9600 bits per second (8 data 7. From the File menu, select Properties >>
bits, no parity, 1 start bit, 1 stop bit, no handshaking). As Settings >> Terminal Keys:
an alternative to a printer, this data may be sent to a log- • Ctrl + H is selected
ging device or to a computer via the serial port COM1 or • Emulation is set to “Auto Detect”
COM2 and Microsoft’s Hyper Terminal program. • Terminal ID is set to ANSI
• Buffer is set to 500
1. Connect one end of a suitable RS232 Null • Tick “append line feeds to receiving ends”
modem Lead to the data port on the lower • Tick “wrap lines that exceed terminal width”
rear panel of the unit. • Click “Ok” to accept port initialisation

2. Connect the other end of the RS232 Null 8. From the Transfer menu, select Capture Text. The
Lead to the COM1 or COM2 port on the PC. incoming data needs to be stored in a file so enter the
name of a directory and filename, e.g., “D:\ NIAGARA
3. Locate the Hyper Terminal program in per\DataLog.txt” or browse around and find a suitable
(Programs\Accessories\Communications\ folder before adding the name of the file you want to
HyperTerminal) and click Hyper Terminal. save the data in. Click ‘START’.

9. The SI PCF Hyper Terminal is now ready

and, if linked to a Niagara Express , will be
receiving data.

Washer ID : 1H15526
Cycle No: 00083

Cycle start P1 14:06:35 17-08-05

4. Enter name, e.g. ‘NIAGARA’, and select an Draining

Draining
14:06:35
14:06:43

icon from those provided. Click ‘OK’. _

10. When the Niagara Express Hyper is closed, all

received data will be saved in the DataLog file. Next time
you use the Hyper Terminal, use the File menu and select
Open. When you choose to open your Hyper Terminal
(i.e., click “SI PCF”), go to the Capture Text menu and
5. By default, COM1 is selected as the
either enter a new file name for the data or retain the
communications port. Click ‘OK’.
existing one, in which case new data will be appended
to it. When you have made your choice, click ‘START’ to
beginr eceiving data when the Niagara Express is started.

6. The name of the Hyper Terminal bar has

changed to ‘NIAGARA – Hyper Terminal’ and you now
have your own Hyper Terminal.

express
Ref: NIAGARA Express UM 16 05/15 Rev.G 16
 3.Operation
Niagara Express

express
Ref: NIAGARA Express UM 17 05/15 Rev.G 17
Section 3-1- Dirty Side Controls User Manual

HMI

Emergency Button

Power Switch

Chemical Storage
Draw

express
Ref: NIAGARA Express UM 18 05/15 Rev.G 18
Section 3-2- Clean Side Controls User Manual

Emergency button

Reset button

Printer

express
Ref: NIAGARA Express UM 19 05/15 Rev.G 19
Section 3-3- Operating Niagara Trolley User Manual

When operating the trolley please make sure that

1. Carrier is locked on the trolley so that it can not come off from the trolley as shown below;

Carrier is locked on
trolley

2. Always apply breakes when loading and unloading the carrier from trolley or from Niagara chamber.

Push down
to lock the
wheel

Press forward to
unlock the wheel

express
Ref: NIAGARA Express UM 20 05/15 Rev.G 20
Section 3-4- Loading Carrier User Manual

1. Place the carrier infront of the chamber. Make sure that the trolley is aligned with white guide on front of
the chamber as shown below.
White Guide

Align trolley in line

with guide

2. When trolley is fully inserted in guide, the carrier will be unlocked automatically.
3. Apply breaks on both wheels.
4. Push carrier into the chamber and make sure that the carrier is fully inserted and it hits the locking plate on
clean side.

Carrier locking plate

Please Note: If carrier is not positioned properly, the locking mechanism will be pushed against the top of the
carrier. Machine will wait for 5 seconds and will open the door for user to re position the carrier. When machine
will open the door, the HMI screen will also go back to “Niagara Screen” so that the user can start the cycle
again.

express
Ref: NIAGARA Express UM 21 05/15 Rev.G 21
Section 3-5- Chemical handling & Replacement User Manual

User must read this message prior to any chemcial handling

CAUTION

• An emergency guideline wall chart of the chemical used in machine must be displayed near the machine.
• Do not use or handle any chemical until you have read and understood the label and the Material Safety
Data Sheet (MSDS) for that chemical.
• In case of any body contact with chemical, always follow emergency procedure given in that particular
chemical’s MSDS or call emergency services.
• Use plastic gloves when handling any chemical.
• Goggles or full face visor to be worn when working with detergent or chemicals.
• It is recommended to wear a plastic disposable apron.
• Use funnel whenever transfering any chemical from one container to another.

Chemical Handling and Replacement

The right hand drawer gives access to the chemical

storage compartment.

The pick up tube consists of a float switch to detect

the level of chemical and a pick up tube - if the re-
maining chemical is low the Niagara Express will not
allow a cycle to be started.

This whole assembly is inserted into the chemical

bottle until the base of the float switch rests on the
bottom.

express
Ref: NIAGARA Express UM 22 05/15 Rev.G 22
Section 3-6- Operating a Wash Cycle User Manual

1. Switch ON the Niagara

2. The HMI screen will show
start up routine and then
will prompt to contine as
below. Press Continue to
proceed to login screen.

Press Coninue to pro-

ceed to Login Screen

express
Ref: NIAGARA Express UM 23 05/15 Rev.G 23
Section 3-6- Operating a Wash Cycle User Manual

3. Press “Log On” to login

user name and pass-
word.

Push “Log On” for

Logon windows.

4. Tap the User Line for a

KEYBOARD to pop up.

Tap User and a Key-

board will be shown to
entre user name.

5. Type user name and by

pressing ENTER, “Log
On”windows will be
Type user name and
shown again.
then press ENTER.

Tap SHIFT to switch betwen small ENTER Button.

and capital letters.
Press ESC to cancel
Login
Backspace(BSP)

express
Ref: NIAGARA Express UM 24 05/15 Rev.G 24
Section 3-6- Operating a Wash Cycle User Manual

6. Tap on “Password” line for

keyboard to enter pass-
word.

7. On typing the pass-

word the characters will
be shown as Asterisk (*).
Press ENTER after typing
password. Log on windows
will be shown again.

8. Press “Log On” to enter the

user mode screen.

express
Ref: NIAGARA Express UM 25 05/15 Rev.G 25
Section 3-6- Operating a Wash Cycle User Manual

9. If username and password

are not correct then standby
windows will be shown
same as on right, where
by pressing “Log In” user
name and password can be
entered again.

10. On successful login, a con-

firmation windows will be
shown with Niagara pro-
grams option at the bottom.

11. Press “Niagara Programs” the At successful longin

Dirty side door will slide down username is shown.
automatically and display will
show available programs.

Press “Niagara
Programs” to see
Niagara Programs

12. Insert a carrier depending

on type of program selected
on screen. If a wrong car-
rier inserted or no carrier
inserted into the chamber,
the P r e C y c l e C h e c k
s t a tus will be failed and
display will prmopt to “In-
sert Carrier”.
Pre Cycle Check
Failed.

express
Ref: NIAGARA Express UM 26 05/15 Rev.G 26
Section 3-6- Operating a Wash Cycle User Manual

13. When a correct carrier is de-

tected by Niagara, display
shows Pre Cycle Check
“Passed” and prompt to
“Start cycle”.

Pre Cycle Check

Passed.

14. To Select a different pro-

gram, tap on “Cycle Type”.
This will be expanded to Touch and hold and
show all other programs. then drag it up and
down to see more
programs.

Tap on arrow to see

all other programs.

15. Tap on any program and will

be shown selected in blue
background.

Program 2 selected

express
Ref: NIAGARA Express UM 27 05/15 Rev.G 27
Section 3-6- Operating a Wash Cycle User Manual

16. To start a cycle press “Start

Cycle”.

Press “Start Cycle” to

start with cycle

17. A confirmation windows will

be shown to confirm pro-
gram number. Press “Yes”
to continue or “No”.

Press “Yes” to start

the cycle

18. Once cycle started, a cycle

status windows is shown.

Cycle Stage:
e.g. Precondition, Pre Chamber
wash, Wash, Disinfect, Temperature
Drying

Stage Function: Press “STOP” to

e.g. Spray Arm, Ultra- abort th cycle
sonic, Irrigation.

express
Ref: NIAGARA Express UM 28 05/15 Rev.G 28
Section 3-6- Operating a Wash Cycle User Manual

19. On completion of a cycle,

machine opens clean side
door automatically and
shows “cycle finished” with
continous buzzer sound.

20. Unload the carrier and

press “reset” button on Reset But-
clean side. The door will be ton
closed automatically.

21. Press “Unloading Finished”

on HMI and screen will go
back to stand by mode.

express
Ref: NIAGARA Express UM 29 05/15 Rev.G 29
Section 3 -7- Aborting a Wash Cycle User Manual

Warning:
Wash chamber may be hot when aborting a cycle. Please wait for wash
chamber & carrier to be cold before unloading.

1. To abort a Cycle at any time

Press “STOP”.

Press “STOP” to
abort th cycle

2. A confirmation windows will

be shown. To abort the cy-
cle press “YES” or to cancel
press “NO”.
3. When “YES” pressed, ma-
chine abort the cycle and
drain out all water.
4. If pressed “NO” machine
continuo with the cycle.
Press “NO” to
Cancel.

Press “YES” to
abort the cycle.

express
Ref: NIAGARA Express UM 30 05/15 Rev.G 30
Section 3 -7- Aborting a Wash Cycle User Manual

5. After aborting a cycle a re-

set windows is shown to
reset the machine. When
all water is drained from the
chamber, Press “Machine
Reset” and machine will go
in standby mode as shown
on next page.

Press “Machine
Reset” to RESET
the machine.

6. On standby mode, another

cycle can be started.

express
Ref: NIAGARA Express UM 31 05/15 Rev.G 31
Section 3 -8 Error during a wash cycle User Manual

Warning:
Wash chamber may be hot when abortied after an error during a cycle. Please wait for wash cham-
ber & carrier to be cool down before unloading or restarting the cycle again.

1. In case of any ERROR

during the cycle, machine
shows an error message on
Error Code:
screen and abort the cycle.
Please see section
This shows error code. This
4-3 for error code and
action also recorded on
their troubleshooting
printout as a “Cycle Failed”.
guide.

Press “Continue” to
acknowldge

2. Press “Continue” to ac-

knowledge and reset win-
dows will be shown to reset
the machine.
3. When all water drains out,
Press “Machine Reset” and
machine will go into stand-
by mode.

Press “Machine
Reset” to RESET
the machine.

4. Machine in standby mode.

express
Ref: NIAGARA Express UM 32 05/15 Rev.G 32
Section 3-9- Important Loading Information
Important Information on Loading Instruments
When loading instruments into a 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 carrier with instruments that are higher
than the basket as this could prevent the rotor arms
from moving.
Do not overload basket.
Ref: NIAGARA Express UM 33 05/15 Rev.G 33
User Manual
Always attach tubing to a Distal Connector of suit-
able 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 instru-
ments are open.
Always ensure that instruments that require ul-
trasonic washing are in the lowest position of the
carrier.
Always dissemble instruments which are
designed to be taken apart.
express
 4.Technical
Niagara Express

express
Ref: NIAGARA Express UM 34 05/15 Rev.G 34
Section 4-1- Technical Specifications User Manual

Medisafe Niagara SI PCF:

Rating Niagara SI PCF

380 - 415 Vac 50Hz MED1445

380 - 415 Vac 60 Hz MED1446

Description: Main
Medical Device Class I to Class IIa Weight:

Intended Purpose: Operational weight: approx. 800kg dry

Internal and external cleaning of surgical approx. 1100kg wet
instruments, hollow-ware, and associated products
Shipping weight: approx. 900kg
Operating Process:
Washing, Irrigation, Ultrasonic & Drying Dimensions:

Applied Standards: Wash Chamber Volume: 470 litres

BS2745: part 1: 1993 Outer Cabinet Dimensions: 1150mm (w)
BS2745: part 3: 1993 1087mm (d)
EN61010-1:2001 2202mm (h)
EN61010-2-040: 2005 Required Services
UL61010-1
EN61010-2-045 (2001) Electricity Supply:
EN61326: 1997
A1: 1998 Supply Voltage: See MED numbers
EN980
EN1717: 2001 Power Consumption:

Environmental conditions: Niagara

(all variants): 21KWH max.
Indoor use;
Altitude up to 2000m; With Fully Steam
Temperature 5°C to 40°C; heated machine: 6.5KWH max
Maximum relative humidity 80% for temperatures up
to 31°C decreasing linearly to 50% relative humidity with electrical
at 40°C; drying steam: 10KWH max
Mains supply voltage fluctuations up to ±10% of the
nominal voltage; Important Note:
Transient overvoltages typically present on the Position the disconnecting device on the building
mains supply (Overvoltage Category II). side near the equipment and ensure easy acces-
Pollution Degree 2 sibility to it.
Warning:
Dangerously high voltages are present inside the
unit. Do not open the cabinet.
Refer servicing and repair to qualified
personnel only.

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Ref: NIAGARA Express UM 35 05/15 Rev.G 35
Section 4-1- Technical Specifications User Manual

Water Supply: Drain:

Main Drain: One at 60.3mm (2.37 inches) OD pipe
Supply Connection (Hot): ¾” BSP Male Union at the bottom of the machine.
or Option: 20mm Hose Tail
Max. Flow to Drain: 180 litres/min
Supply Connection (Cold): ¾” BSP Male Union Max. Temp. of Effluent: 95OC
or Option: 20mm Hose Tail
Ventilation:
Supply Connection (Hot RO): Max. Heat Output of Load: 95OC
¾” BSP Male Union (2x if RO water is also used on
rinse)
or Option: 20mm Hose Tail Chemicals:

Acceptable Pressure Range: 2-5 bar for RO, Size and Nature of Containers:
hot and cold 3E-Zyme® Fluid: 10 litre plastic bottle
Acceptable Flow Rate: not less than 20
litres/min Storage Instructions:
3E-Zyme® Fluid: Refer Data sheet provided
Volume Used per Cycle: with chemical
Prewash, rinse and disinfect, approx. 40 litres per
stage. Wash approx. 97 litres Safe Handling Instructions:
3E-Zyme® Fluid: Refer Data sheet provided
Acceptable Temp. Range: with chemical.
Hot: 60-90OC (140-194OF)
Cold: <30OC (86OF)

Hardness (CaCo3): not more than 150 ppm

Steam Supply:

Fully Steam heated Machine:

Mass Flow: 31Kg/hour

Pressure: 2 Bar
Temperature: 185 oC
Connection: 1 Inch BSP pipe

Electrical Drying Machine:

Mass Flow: 26.4Kg/hour

Pressure: 2 Bar
Temperature: 185 oC
Connection: 1 Inch BSP pipe

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Ref: NIAGARA Express UM 36 05/15 Rev.G 36
Section 4-2- Niagara Program Parameters User Manual

Program No. P1 P2 1T 2T 3T 4T

Pre wash mins 2 2 2 2 2 2

Max 40OC
Spray time secs 40 40 40 40 - -
Irrigation time secs 20 20 20 20 - -
Chemical Dose ml - - - - - -

Wash Time mins 7 6 7 6 - -

Wash temperature C o
40 40 40 40 - -
Chemical 1 dose ml 350 350 350 350 - -
Chemical 1 dose ml - - - - - -
Spray time secs 30 30 30 30 - -
Irrigation time secs 20 30 20 30 - -

Rinse 1 2 2 2 2 - -
Rinse 2 - - - - - -
Rinse 3 - - - - - -
Chemical Dose ml - - - - - -
Irrigation time secs 20 20 - - - -

Disinfect time min 1 1 - - 1 -

Disinfect temp oC 92 92 - - 92 -
Irrigation time secs 20 20 - - 20 -

Drying time min, sec 13.20 13.20 - - - 13.20

Approx time mins 36 35 - - - -

The Programs are selected by the load carrier recognition system.

P1 - Standard wash with ultrasonics

Engineering test programs.

To enable validation testing. Can only be accessed with engineering pass word.

T1 Pre-wash, Wash and Rinse

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Ref: NIAGARA Express UM 37 05/15 Rev.G 37
Section 4-3- Process Monitoring User Manual

Throughout the entire cycle, various factors are monitored and, if necessary, acted upon by the micro-
processor. Some of these factors:

Temperature Error:
At various times during the cycle the two temperature sensors are compared for accuracy, if there is a difference
of more than 5 degrees the cycle will fail.

Chemical Low:
A float switch in each bottle; Chemical 1, Chemical 2 and Chemical 3 monitors the Chemical level. A cycle will
not start if it detects that there is insufficient chemical remaining to complete the cycle.

Data Output:
All parameters reported by the unit during each cycle are output as a serial data stream (RS232) for logging
either on a printer, or as text files on a PC equipped with suitable software.

Note:
In case of a fault or cycle failure, machine will drain automatically and an access password will be requested on
the HMI to reset.

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Ref: NIAGARA Express UM 38 05/15 Rev.G 38
Section 4-4- Routine Checks User Manual

To ensure that the Medisafe Niagara Express continues to operate within its design parameters it is recom-
mended that the following checks are performed on a regular basis. Consulting the troubleshooting guide in 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 suit-
ably qualified engineer.
Daily Checks Weekly Checks
Check if there is sufficient chemical for the days
Dirty and Clean Side Door Seal Condition
planned use.

Clean / Replace Filters in the Chamber Dirty and Clean Side Door Lifting and Safety Devices

Check Spray Arms for Free Rotation Check liquid containing parts and hoses for leaks
Check Spray Nozzles for Blockages Check for any mechanical damage

Filters in place:

Filters removed. (The filters just lift out):

Important Note
Running the Niagara Express without the filters in place can seriously damage the pumps or valves and cause
any fine lumens to become blocked.

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Ref: NIAGARA Express UM 39 05/15 Rev.G 39
Section 4-5- Troubleshooting Guide User Manual

Warning

For Repair and Maintenance please disconnect main Electricity supply and compressed air supply should be supplied in
order to manually operate pneumatic devices.

NIAGARA ERROR CODES

Error Code Error Message Displayed
1 Disinfection Tank Overflow
2 Wash Tank Overflow
3 Disinfection Tank Filling Time
4 Wash Time Filling Time
5 Drain Blockage
6 Chamber Water Level Low
7 Chamber Overflow
8 Pump Pressure Low
9 Pump Pressure High
10 Disinfection Tank Overheating
11 Wash Tank Overheating
12 Disinfection Tank Heating Element Failure
13 Wash Tank Heating Element Failure
14 Chamber Heating
15 Chamber Heating Element Failure
16 Disinfection Tank Temperature out of range
17 Wash Tank Temeprature out of range
18 Chamber Temperature out of range
20 Air Heater Box Overheating
22 Air Heater Box Heating Element Failure
24 Air Heater Box Temp Out of Range
26 Prewash Temp Too High
27 MainWash Temp out of set Limits
28 Disinfection Temp out of set Limits
29 Chamber Temperature Probe Error
30 Clean Side safety Edge
31 Unclean Side Safety Edge
32 Air Pressure Low
41 Flowmeter 1 Time Limit
42 Flowmeter 2 Time Limit
43 Flowmeter 3 Time Limit
44 Flowmeter 4 Time Limit

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Ref: NIAGARA Express UM 40 05/15 Rev.G 40
Section 4-6- Failure Mode Access User Manual

In event of a fault, whereby the doors cannot be operated. In order to have safe access in
chamber to remove instruments, please follow the instructions below.

1. Turn the compressed air supply to the machine OFF; this will disable the actuation of the pneumatic cylinders
allowing the doors to unseal.

2. With a No.4 Allen Key unscrew the coupler on the door motor. Please see the picture

Caution:
Please note that the door will be unsupported, therefore it will slide down on its own weight.

unscrew the coupler from one end

express
Ref: NIAGARA Express UM 41 05/15 Rev.G 41
Section 4-7- Warranty
To ensure continued efficiency and long operational
life, your new Niagara Express is covered by one year
warranty/5,000 cycle warranty whichever is reached first.
It 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
“Niagara”) 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 Sonic
Irrigator which are warranted by an authorised Medisafe
dealer or distributor within 12 months or 5,000 cycles
(whichever occurs first) of the WARRANTY START DATE
when this new Sonic Irrigator is first 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 or 5,000 cycles (whichever
occurs first) from the WARRANTY START DATE against
defects in manufacture.
• Solenoid valves
• Electric motors and pumps
• Switches
• Electronic control circuits
• Water heating elements
• Ultrasonic transducers
Ref: NIAGARA Express UM 42 05/15 Rev.G
User Manual
THE SPECIFIC EXCLUDED ITEMS
THE SPECIFIC EXCLUDED ITEMS are any items of the
Niagara Express 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 Washer (for example:
Door seal, water inlet filter element, various types of
gaskets and hoses, lamp bulbs (if fitted), and other
expendable parts not specifically listed)
Fair wear and tear of any part, normal maintenance
service items, and the parts and any material used in
connection with Niagara Express .
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 Niagara Express parts thereof (e.g. Slight
noise or vibration) or which appear only under particular
abnormal conditions.
Damage caused by insufficient or improper maintenance
(e.g. negligence of the daily, weekly, and monthly periodic
inspections and any servicing requirements as described
and specified 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.
1
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42
Section 4-7- Warranty
Damage caused by accident, abuse, or negligence of
the proper handling as set out in this Owner’s Manual,
misuse of the Niagara Express, use of the under unusual
conditions, and modifications of or to the Niagara Express
or any Niagara Express component/parts thereof not
recommended or approved by an authorised Medisafe
dealer or distributor.
Damage caused by external influences such as chemical
spillage, accident, fire, 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 Niagara Express, which may
come into contact with the load carrier during the process
of loading/unloading the Niagara Express.
Ref: NIAGARA Express UM 43 05/15 Rev.G
User Manual
All charges incidental to breakdowns, such as loss of
use of the Niagara Express, loss of time, inconvenience,
telephone, transportation, loss or damage to personal
property or loss of revenues, or other matter not
specifically included.
Damage caused by incorrect installation of the , which
Niagara Express 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 final decision on
all manufacturers’ warranty claims.
Nothing herein affects the statutory rights of a
consumer.
2
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43
Section 4-8- Service Record User Manual

Medisafe recommend that your is Important Note:

serviced in accordance with the schedule contained
within the User Manual at intervals
of 3 months. This record should be completed by
the Engineer conducting the Service and should be
made available in the event of a warranty claim or
breakdown repair.
NO user serviceable parts inside. Service and repair
should be referred to qualified persons only.
In the event that the product supplier (or Medisafe UK
Ltd.) is not chosen to provide this service, Medisafe
UK Ltd can supply a detailed User Manual on request.

3 Month 6 Month 9 Month

Serviced by/Date Serviced by/Date Serviced by/Date

Cycles since last Cycles since last Cycles since last

service service service

Next service due Cycles date Next service due Cycles date Next service due Cycles date

12 Month 15 Month 18 Month

Serviced by/Date Serviced by/Date Serviced by/Date

Cycles since last Cycles since last Cycles since last

service service service

Next service due Cycles date Next service due Cycles date Next service due Cycles date

21 Month 24 Month 27 Month

Serviced by/Date Serviced by/Date Serviced by/Date

Cycles since last Cycles since last Cycles since last

service service service

Next service due Cycles date Next service due Cycles date Next service due Cycles date

30 Month 33 Month 36 Month

Serviced by/Date Serviced by/Date Serviced by/Date

Cycles since last Cycles since last Cycles since last

service service service

Next service due Cycles date Next service due Cycles date Next service due Cycles date

express
Ref: NIAGARA Express UM 44 05/15 Rev.G 44
Section 4-9- Decontamination Guide
All medical washers should be cleaned weekly as part of
the routine maintenance for operator’s Health and Safety,
for the purposes of routine maintenance (PRIOR to the
arrival of the engineer) and for transportation.
By decontamination, we refer to the unit being cleaned
and disinfected.
Machines returned in an un-cleaned state WILL incur
additional charges for cleaning and decontamination.
For the internal or external surfaces a disinfectant cleaner
(e.g. Medisafe DISS-ALL - product code MED8051), or
any household kitchen cleaner can be used providing it is
marked as a DISINFECTANT CLEANER.
Important safety information:
All safety precautions recommended for the cleaning
product used must be adhered to.
In all cases, the wearing of PPE, including gloves and
eye-shields are strongly recommended.
Cleaning/decontamination general instructions.
Apply the chosen chemical onto a clean cloth or paper
towel and wipe over the surfaces as mentioned below.
Rinse off with tap water on a cloth or paper towel and dry.
Ref: NIAGARA Express UM 45 05/15 Rev.G
User Manual
For machines with a tank assembly (such as…..) the tank
must be filled with clean water containing a 5% solution
of household bleach (Sodium Hypochlorite) and then
rinsed with clean water.
The internal area that is not immersed including the
underside of the lid must also be disinfected.
All units must be drained down thoroughly prior to return.
Note:
By the nature of its operation, this washer disinfector has
a tank or chamber area that is immersed in water during
all phases of the cleaning/disinfection cycle. Therefore
the main tank/chamber should be clean and disinfected
at the end of the cycle.
All that is required then is to clean and disinfect the
outside surfaces, and around the sides of the door and
door seals/hinges, as the normal wash process will not
clean them.
If, however, due to the nature of any fault present, the
unit cannot be run prior to return, the tank/chamber must
be cleaned and decontaminated by hand following the
process outlined in the notes above.
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45
Section 4-10- Decontamination Certificate User Manual

DECONTAMINATION CERTIFICATE

ENSURE THAT ITEMS RETURNED TO YOUR SUPPLIER ARE

DISINFECTED IN ACCORDANCE WITH THE APPROPRIATE HOSPITAL
PROCEDURE FOR EQUIPMENT OF THIS TYPE

WHEN RETURNING THE PRODUCT TO YOUR SUPPLIER THIS FORM

MUST BE COMPLETED AND ATTACHED TO THE OUTSIDE OF THE CAR-
TON. WITHOUT THIS FORM BEING VISIBLE THE COURIER AND/OR YOUR
SUPPLIER ARE AT LIBERTY TO REFUSE HANDLING
OF THE PRODUCT.

I hereby certify that the machine referred to in this document

by model number and serial number has been disinfected in
accordance with Hospital Prededure

Model Number:

Serial Number:

Hospital:

Name:

Signature: Date:

Promoting a Clean and Safe Service

express
Ref: NIAGARA Express UM 46 05/15 Rev.G 46