Medisafe PCF Pro User Manual

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PCF Pro

User Manual

DOC01851

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PCF Pro User Manual

REPRODUCTION OF THIS MANUAL IN ANY MEDIUM WITHOUT THE EXPRESS PERMISSION OF MEDISAFE IS PROHIBITED.

LIMITED RIGHTS NOTICE TECHNICAL DOCUMENTATION/DATA

This technical manual shall not, without the written permission of MEDISAFE be either (a) used, released, disclosed, or reproduced in whole or in part or (b) used in whole or in part for manufacture except that (i) such release, disclosure or use is necessary for emergency repair or overhaul; (ii) such release, disclosure, or use is made subject to a prohibition that the person to whom the data is released or disclosed may not further release, disclose, or use such data; (iii) MEDISAFE is notified of such release, disclosure or use.

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Amended Ultrasonics frequency in the general

Record of Revisions

EVISION

NUMBER

1 Original Issue. W. Leslie 12-Jan-17

ESCRIPTION OF CHANGE / LOCATION OF CHANGE

ATE

2 Updated certification section, direction pump, changed

carrier name to basket.

3 Updated PCF Pro parameters. Added copyright

information, table of revision, luer pipes sections.

specifications section. Amended daily check section.

E. De Bruijn 11-Aug-17

W. Leslie A. Ahmed

24-Aug-17 30-Jan-18

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Table of Contents

1. INTRODUCTION ............................................................................................................................................ 7

Medisafe Contact Details ......................................................................................................................... 8

Independent Monitoring .......................................................................................................................... 9

Service and Maintenance Requirements ................................................................................................. 9

PCF Pro Warranty Registration .............................................................................................................. 10

Safety Precautions ................................................................................................................................. 12

Training Personnel ................................................................................................................................. 15

Compliance ............................................................................................................................................ 16

Product Identity ..................................................................................................................................... 16

Manufacturer Information ..................................................................................................................... 16

Intended Use ........................................................................................................................................ 17

Performance ........................................................................................................................................ 17

Cycle Record ......................................................................................................................................... 17

Cycle Failure ......................................................................................................................................... 17

Concept Summary ................................................................................................................................ 17

General Safety...................................................................................................................................... 18

Chemicals ....................................................................................................................................................... 18

Decontamination ........................................................................................................................................... 18

Heat................................................................................................................................................................ 18

Electrical Safety .................................................................................................................................... 18

Service Contracts & Warranty.............................................................................................................. 18

Validation Option ................................................................................................................................. 18

2. INSTALLATION ............................................................................................................................................ 19

Transport and Storage ........................................................................................................................... 20

Marking ............................................................................................................................................................ 20

Environmental .................................................................................................................................................. 20

Lifting ..................................................................................................................................................... 20

Unpacking .............................................................................................................................................. 20

Returns ................................................................................................................................................... 20

Enclosures Check List ............................................................................................................................. 21

PCF Pro Accessory Kit (MP21223) .................................................................................................................... 21

PCF Pro Plumbing Kit (MP21225) ..................................................................................................................... 21

Additional Accessories ........................................................................................................................... 22

Printer .............................................................................................................................................................. 22

Approved Chemicals ........................................................................................................................................ 22

Installation Requirements ...................................................................................................................... 23

Connecting the PCF Pro .......................................................................................................................... 25

Installation Drawings ............................................................................................................................. 26

Rear View Showing Services............................................................................................................................. 26

Front View ........................................................................................................................................................ 27

Left Side View with Lid Closed showing Drain Connection .............................................................................. 28

Left Side View Lid Open ................................................................................................................................... 29

CONNECTING TO THE RS232 PORT ........................................................................................................................... 30

Thermal Printer .................................................................................................................................... 30

Data Logging PC................................................................................................................................... 30

3. OPERATION ................................................................................................................................................ 31

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Menu ...................................................................................................................................................... 32

Power Up ............................................................................................................................................... 33

Authorisation code ................................................................................................................................. 33

Setting Time & Date ............................................................................................................................... 34

Set Time ........................................................................................................................................................... 34

Set Date ............................................................................................................................................................ 34

Selecting a program ............................................................................................................................... 35

Standard Program Parameters......................................................................................................................... 35

Chemical Handling ................................................................................................................................. 36

Chemical Consumption .................................................................................................................................... 36

Chemical Replacement .................................................................................................................................... 36

Disposal of chemical containers ....................................................................................................................... 36

Chemical Priming ............................................................................................................................................. 36

Baskets ................................................................................................................................................... 37

Basket Removal ................................................................................................................................................ 37

Basket Insertion ............................................................................................................................................... 37

Luer pipes ......................................................................................................................................................... 38

Instruments ...................................................................................................................................................... 39

Instrument Loading Precautions ...................................................................................................................... 39

Carrier Lift Controls .......................................................................................................................................... 40

Light Guard....................................................................................................................................................... 40

Safety Edge ...................................................................................................................................................... 40

Emergency Stop ............................................................................................................................................... 40

Testing Operation of the Safety Devices ........................................................................................................ 41

To check operation of the carrier lift:........................................................................................................................ 41

Starting a Cycle ...................................................................................................................................... 42

Automated Wash Cycle .......................................................................................................................... 43

Cycle Process .................................................................................................................................................... 43

Pre-wash .......................................................................................................................................................... 44

Wash ................................................................................................................................................................ 44

Rinse................................................................................................................................................................. 45

Final Rinse/Disinfection ................................................................................................................................... 45

Cooling ............................................................................................................................................................. 46

Drying ............................................................................................................................................................... 46

Cycle Complete ................................................................................................................................................ 46

Unload .............................................................................................................................................................. 46

Re-Wash Cycle ............................................................................................................................................... 47

Cycle Errors .......................................................................................................................................... 48

Aborting a Cycle ................................................................................................................................... 48

LED Edge .............................................................................................................................................. 49

Routine Maintenance........................................................................................................................... 49

Before Every Cycle ......................................................................................................................................... 49

Daily Checks ................................................................................................................................................... 50

Weekly checks ................................................................................................................................................ 51

Decontamination Guide ....................................................................................................................... 52

Daily Cleaning/ Procedure.............................................................................................................................. 52

Full Decontamination ..................................................................................................................................... 52

Pre Transport Procedure ................................................................................................................................ 52

Decontamination Certificate .......................................................................................................................... 53

Downloading the Cycle Log .................................................................................................................. 54

Download Logs ............................................................................................................................................... 54

4. TROUBLESHOOTING ................................................................................................................................... 55

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Error Messages ...................................................................................................................................... 56

Other Faults ........................................................................................................................................... 58

5. TECHNICAL ................................................................................................................................................. 59

General Specifications ............................................................................................................................ 60

Applied Standards .................................................................................................................................. 64

6. APPENDICES ............................................................................................................................................... 65

EMC .................................................................................................................................................................. 66

EMC & Electromagnetic Compatibility Data .......................................................................................... 66

Electromagnetic Emissions .................................................................................................................... 67

Electromagnetic Immunity ..................................................................................................................... 68

Separation Distances Between PCF Pro and Mobile RF Equipment ....................................................... 70

Warranty ................................................................................................................................................ 71

Service Record ........................................................................................................................................ 72

Operator PIN Number Codes.................................................................................................................. 73

Symbols Glossary ................................................................................................................................... 74

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User Manual

1. Introduction

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Medisafe Contact Details

United Kingdom

(Manufacturing, Sales, Customer Service & Technical Support)

Medisafe UK Ltd

Unit 1 Twyford Industrial Estate

Twyford Road

Bishop’s Stortford

Hertfordshire CM23 3LJ

England

Tel: +44 (0) 1279 461641

Fax: +44 (0) 1279 461643

E-mail [email protected]

www.medisafeinternational.com

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Introduction

Important

Read this entire manual before attempting to install, operate or perform any maintenance on the Parametric Controlled Flow (PCF) Pro Ultrasonic Cleaning System. Ensure all appropriate personnel understand the contents of this manual.

This Operating Manual contains important information on proper use and maintenance of the PCF Pro Ultrasonic Cleaning System. All personnel involved in the use and maintenance of this equipment must carefully review and comply with the warnings, cautions and instructions contained in this manual. These instructions are important to protect the health and safety of personnel operating the Ultrasonic Cleaning System and should be retained in a conveniently accessible area for quick reference.

Advisory

A listing of the Safety Precautions to be observed when operating the PCF Pro Ultrasonic Cleaning System is found in Section 1-5 of this manual. Do not operate the equipment until you have become familiar with this information.

Independent Monitoring

Important Note for the Product Owner

It is advised that an independent monitoring system is fitted in accordance with ISO 15883-1:2009 Washer-disinfectors.

Service and Maintenance Requirements

The PCF Pro should be serviced on a regular basis to ensure that the product continues to perform in accordance with its design parameter, see section 6-6 for more information.

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halts carrier lifting system

raises up by approximately 30mm

For one side test Safety Edge activation during upward motion halts the lifting system

PCF Pro Warranty Registration

Important Note for the Installer

This Registration Form MUST be completed by the person undertaking installation and witnessed by the owner of 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. 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). A copy of this form must be sent to your local Medisafe authorised distributor to validate the warranty.

Tests parts one and two must be completed by the engineer commissioning the PCF Pro for warranty registration purposes. Where no value is required write pass or fail with a comment if necessary.

For installation instructions and contact information for qualified personnel who can perform the installation, please contact Medisafe (see section 1-1).

Owner Name:

Installation Address:

Installation Date:

Model No:

Serial No:

Software Version:

Installed by:

Witnessed by:

Position:

Part 1, Test Type Acceptable Value Result Comments

Drains remove effluent effectively

Phase sequence, Pump Rotation

Support bases secure

There is no evidence of interference to or from other equipment connected to the same services

Emergency stop operates and

For all 5 sections test Safety Edge activation during downward motion halts lifting system then

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Test Through beam sensor basket obstruction along

<300µS/cm (Soft)

Part 1, Test Type Acceptable Value Result Comments

machine front edge during downward motion halts lifting system then raises up by approximately 30mm

machine front edge during upward motion halts lifting system

Compressed Air

Hot Water Hardness (As specified by WD Manufacturer)

Cold Water Hardness (As specified by WD Manufacturer)

Hot Water Temperature

Cold Water Temperature

Hot Water Pressure

Cold Water Pressure

5.5 – 7 bar

(80 - 100 psi)

125 ppm (max)

50°C (122°F) min

80°C (176°F) max

5°C (41°F) min

30°C (86°F) max

2 - 5 bar

(30 – 70 psi)

2 – 5 bar

(30 - 70 psi)

Part 2, Final rinse water Acceptable Value Result Comments

Rinse water supply Type

If softened, Hardness

Water Pressure

Temperature

Electrical conductivity

RO, DI, Softened

< 125 ppm

2 – 5 bar

(30 – 70 psi)

5°C (41°F) min

80°C (176°F) max

<30µS/cm (RO)

<10µS/cm (DI)

Signed Name Date

Comments / remedial work

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Wear appropriate Personal Protective Equipment (PPE) whenever handling

Wear appropriate Personal Protective Equipment (PPE) whenever removing

Since temperatures within the unit can reach 92°C (198°F) during and after

Safety Precautions

The following Safety Precautions must be observed when operating or servicing the PCF Pro. WARNING indicates the potential for personal injury and CAUTION indicates the potential for damage to equipment. For emphasis, certain Safety Precautions are repeated throughout the manual. It is

important to review ALL Safety Precautions before operating or servicing the unit.

Warning – Pinching Hazard

Pinch points are created during lid articulation. Keep hands clear when opening or closing the lid.

In the unlikely event of an uncontrolled fault, the emergency stop button can be pushed to cut power for the Carrier Lift and other critical outputs.

Warning – Breathing Hazard

Some cleaning solutions emit harmful vapours. Only use cleaning solutions in wellventilated areas. Do not inhale vapours. Do not permit solution vapours to exceed maximum allowable concentrations in the work area. Ensure adequate ventilation.

Warning – Chemical Burn and/or Eye Injury Hazard

• Detergents are caustic and can cause adverse effects to exposed tissues. Do not get in eyes, on skin or attempt to ingest by mouth.

• Read and follow precautions and instructions on detergent label and in the Material Safety Data Sheet (MSDS) prior to handling chemical, refilling chemical containers or servicing chemical injection pumps and lines.

• chemicals or servicing chemical injection pumps and lines. This should include plastic gloves, goggles or full-face visor, and disposable plastic apron.

• baskets or parts from cleaning chamber.

• In case of body contact with chemical, always follow emergency procedure given in that chemical’s MSDS or call emergency services.

• Use a funnel when transferring any chemical from one container to another.

Warning – Burn Hazard

• operation, take care when opening lid at the end of a cycle. Allow sufficient time for items to cool before handling, cleaning or maintenance procedures.

• Wear appropriate Personal Protective Equipment (PPE) whenever reaching into Chamber after a thermal disinfection operation.

• Under no circumstances attempt to forcibly open the lid during operation.

• During reloading of instruments in the re-wash program the water temperature

within the unit can reach 60°C (140°F), when opening the lid and reloading the instruments take care and wear appropriate PPE.

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detergent mix in cleaning chamber. Never use

or electric shock, do not expose equipment to

Isolate electrical supply by turning the buildings disconnect switch to OFF

immediately wipe up any spilled liquid or

condensation. If spills or leaks could contain detergents or other chemicals,

t or

. Maintenance performed by unqualified

Regularly scheduled preventive maintenance, in addition to the faithful

Warning – Explosion Hazard

Use only water or waterflammable or combustible cleaning liquids. Fire or explosion could result.

Warning – Electric Shock Hazard

• To prevent the risk of fire unnecessary moisture. Always ensure that all external surfaces are dried after each cycle.

• When removing a basket, allow to drain into the chamber before moving to the next cleaning station. Excess water spillage may cause electrical shock and serious injury.

• Disconnect all utilities to unit before servicing. Do not service unit unless all utilities have been properly locked out. Always follow local occupational health and safety regulations, as well as electric and plumbing codes.

• before checking or replacing any parts. Electrical shock can cause serious injury.

Warning – Slipping Hazard

To avoid slippery floor conditions,

follow safety precautions and handling procedures set forth on detergen chemical label and/or MSDS.

Warning – Personal Injury and/or Equipment Damage Hazard

• Only Medisafe or Medisafe-trained service personnel must make repairs and adjustments to this equipment personnel or installation of unauthorized parts could cause personal injury, result in improper equipment performance, invalidate the warranty, or result in costly damage. Contact Medisafe regarding service options.

• performance of routine maintenance described within the service manual, is required for safe and reliable operation of this equipment. Contact Medisafe to schedule preventive maintenance.

• Failure to perform periodic service inspections of the machine could result in serious personal injury or equipment damage.

• Do not wear loose fitting clothing, neckties or jewellery that could become entangled in moving parts.

• Never reach into a chamber when unit is in operation.

• Always use a basket to reprocess instruments within the unit.

• Never reach into a chamber if the carrier lift is jammed.

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When choosing a detergent, select one with a low chloride content.

and forth motion, in same direction as surface grain.

into the tank.

port. Otherwise, wash

• Always confirm compatibility with the instrument manufacturer.

f any instruments became detached from the Medisafe connection tubing

connection is firmly seated.

Caution – Possible Equipment Damage

• Never place items or person(s) on the lid, this is particularly important while operating the carrier lift.

• Ensure the thumb ball latches in the down position before moving the carrier lift.

• Never place items on the machine which could obstruct the lid from closing.

• Never attempt to obstruct the lid from closing.

• All baskets must be fitted when running a cycle.

• Do not place items directly into the wash tank or allow them to make contact

with the tank sides.

• Never scratch chamber walls. This can increase cavitation erosion.

• Do not load basket with instruments pointing at the lid.

• Do not overload the basket, maximum load of 10kg (22lbs) per basket.

• Do not allow Luer pipes to protrude from the basket.

Caution

• Always use a Full DIN Tray Standard to hold instruments (M20044).

•

Detergents with a high chloride content can be harmful to stainless steel.

• Repeated fuse blows or circuit breaker trips indicate a short circuit or overload. Have a fully trained technician locate and correct situation.

• Use nonabrasive cleaners when cleaning unit. Follow directions on container and rub in a backAbrasive cleaners damage stainless steel. Cleaner rubbed in a circular motion or applied with a wire brush or steel wool will scratch and dull stainless steel.

• Avoid running equipment into the Control Panel or Touch Screen to prevent damage to controls.

• When removing baskets always tilt down to ensuring any retained water drips

Caution – Chemical

• Chemical bottles must be connected to the correct efficiency and/or rinsing will be compromised. Ensure that the chemical type

Caution

matches the port shown on the display.

• Check chemical bottles are in date before use

Caution – Instrument Care

• Always follow the manufacturer’s instructions if processing instruments with special characteristics e.g. fibre optics or rigid optics.

• Whether pre or post processing instruments, always follow the manufacturer’s instructions.

• Always attach tubing to a suitable size distal connector for instruments being

Caution

cleaned or to a quick connect port if the instrument has one.

• Always open box jointed instruments.

• Always ensure taps are open on cannulated instruments.

• Always dissemble instruments that are designed to be taken apart.

• Visually inspect instruments after reprocessing

• I

during processing, they should be reprocessed after ensuring that the Luer

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Training Personnel

The owner of this equipment has the responsibility for training the users and keeping the appropriate records.

There should be regular training of all personnel concerned with the operation and maintenance of the equipment. The training schedule shall include:

• Operation of the machine (see section 2-10, 3-1, 3-4-1, 3-4-2, 3-5, 3-7 , 3-8, 3-9 and 3-

12).

• Safe use of machine (see section 1-5)

• Chemical handing (see section 3-6)

• Emergency Procedures e.g. how to handle the load in case of aborted cycle (see

section 3-9-10 and 3-11)

• Regular maintenance procedures (see section 3-13 and 3-14)

• Troubleshooting (see section 4)

The following table can be used for keeping training records.

Date Name Title of Training Signature of Trainer

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Compliance

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

Commitment to RoHS and WEEE Requirements

Medisafe is committed to meeting or exceeding the requirements of the RoHS CE Marking directive (2011/65/EC) (Restriction of

the Use of Certain Hazardous Substances in Electrical and Electronic Equipment).

Medisafe is also committed to meeting all requirements of the WEEE directive (2012/16/EU) (Waste Electrical and Electronic Equipment).

WEEE and Battery Disposal

Waste electrical and electronic products must not be placed in the general refuse but collected

separately. Separately collected WEEE products are to be sent to an approved recycling or disposal operators for safe recycling, recovery or reuse.

Medisafe UK Ltd is registered with the "B2B Compliance" Scheme. B2B Compliance on behalf of Medisafe, takes on the legal responsibilities of the reporting, collection and treatment of, all WEEE that Medisafe UK Ltd is obligated for - and ensures that the appropriate recycling targets are met. .For independent confirmation of Medisafe UK Ltd status can call B2B Compliance on 0845 680 9829 or visit www.b2bcompliance.org.uk

To fulfil our B2B WEEE take-back obligations, B2B Compliance will undertake the appropriate collection and disposal of obligated products of Medisafe UK Ltd.

If a Medisafe Product has reached its end of life, please contact B2B Compliance collections team on 0845 680 9829 or

[email protected]

collection and treatment.

Otherwise, please recycle where facilities exist. Check with your Local Authority or Distributor for recycling advice.

to arrange

Declaration of CE Conformity

The PCF Pro 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 IIb devices through the application of rule 15 within Annex IX of the Medical Devices Directive 93/42/ EEC.

Product Identity

The model and serial number label are located on the inside panel of the chemical compartment.

Example of serial number label:

The software version is shown on the front panel display when the unit is first switched on.

Manufacturer Information

Medisafe UK Ltd Unit 1 Twyford Industrial Estate Twyford Road Bishop’s Stortford Hertfordshire CM23 3LJ England

Tel.: +44 (0) 1279 461641 Fax: +44 (0) 1279 461643

E-mail [email protected]

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Intended Use

The Medisafe Sonic Irrigator PCF Pro is a High-Pressure, Ultrasonic, Flushing Washer Disinfector for the medical market. It is intended to provide cleaning and low-level thermal disinfection of surgical instruments, including complex lumen/cannulated devices, such as robotic surgical instruments.

This is achieved through a combination of ultrasonics and a flushing action to remove debris from both the outside and inside (hollow instruments only) of items placed within the wash tank.

Note: If the equipment is used in a manner not specified by the manufacturer, the effectiveness and protection provided by the equipment may be impaired.

Performance

Washing is achieved using a unique, specially formulated and clinically validated decontamination fluid (EDA+ or 3E-Zyme®), which is introduced into the machine during the cycle.

This machine has a class AB weir incorporated into the tank design to comply with most water authority regulations.

A stringent quality control program ensures that every unit is manufactured and tested under controlled conditions to ensure that all units perform identically.

Cycle Record

During the cycle, parameters are reported at key stages of the process as an ASCII serial data steam via the RS232 port. This can then be logged either on a printer (see section 2-6-1 and 2-10) or on a PC (see section 2-11).

The on-board cycle log can be download via a USB flash drive (see section 3-15).

Cycle Failure

The PCF Pro is designed to perform within strict and carefully controlled tolerances. If an unexpected condition occurs during a wash cycle, the system will abort the cycle and report an error, see section 3-9-10 for more details.

Concept Summary

The PCF Pro has been designed as a standalone high pressure sonic irrigation washer disinfector, with the ability to wash up to sixty instruments and offer the option of a disinfection stage at the end of the wash.

There are six pre-defined user selectable programs with Pre-wash, Wash, Rinse and

Disinfection stages tailored to clean a multitude of different loads.

The program parameters can also be changed within specified limits by an engineer during installation or service.

Load Instruments

The user loads the instruments into the basket using the foot switch to raise and then lower the electrically actuated Carrier Lift in an automated sequence.

Prewash

The cycle begins with a cold-water fill to the mid-level; the spray and irrigation valves are opened alternately with the pump running for the specified time. The water is then drained.

Wash

At the main wash stage, the tank is filled to the top level with a cold and hot water mix to attain a set temperature. Detergent is also added at this point. To even out the temperature, fill all cavities, and to mix the chemical thoroughly the pump is pulsed on and off. Once the tank is full the ultrasonics degas the tank by pulsing on and off to remove any dissolved air. A period of irrigation follows in order to flush any material from inside the instruments. The ultrasonics then alternate with irrigation for the set period of time. The water is then drained.

Rinse

The tank is filled with water to the mid-level; the machine will then alternate between the spray and irrigation for the pre-defined period of time. The water is then drained.

For some programs this stage is repeated.

Disinfection

If disinfection is required, the machine is then filled to the minimum level with hot water and heated up to the pre-set temperature (91°C / 196°F) for 3 minutes. The water is then drained.

Cooling

To disperse the vapour in the chamber, the machine opens the drain valve and runs cold water down the back wall of the tank.

Drying

To clear the excess water from the irrigation and spray channels, compressed air is alternately injected at regular intervals.

Unload

The user presses the foot switch to open the Carrier Lift and unload one level at a time in an automated sequence.

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General Safety

This equipment 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 a high pressure sonic irrigation washer disinfector.

Chemicals

Since this equipment contains a high power heating device, the use of substances or chemicals, other than those specified by Medisafe, may be hazardous. Therefore, always read the manufacturer’s chemical safety information before use and never use toxic, corrosive, or flammable liquids.

Using non-approved chemicals may cause damage to your machine and could void your warranty and guarantee of performance.

Decontamination

In the event that this product needs to be returned to the supplier, it MUST first be fully decontaminated before transporting. The

Decontamination Certificate (see section 3-14-

4) must also be completed and displayed in a

prominent position when returned with the product.

Heat

Since temperatures within the unit can reach 92°C during and after operation, take care when opening lid at the end of a cycle. Allow sufficient time for items to cool before handling.

(198°F)

Electrical Safety

Dangerously high voltages are present inside the machine. Do not remove any panelling, or attempt to gain access to the inside of the machine. Refer servicing and repair to qualified personnel only.

To avoid risk of electric shock, this equipment must only be connected by a fully qualified electrician and to a mains supply with a protective earth.

To prevent the risk of fire or electric shock, do not expose equipment to unnecessary moisture. Always ensure that all external surfaces are dried after each cycle.

Service Contracts & Warranty

Your PCF Pro is supplied with a conditional 12-month parts warranty, which is effective from the date of installation.

Medisafe (UK) offers a range of Service Contracts and Extended Warranty Packages to provide continuous maintenance and breakdown cover once the original warranty has expired.

Hazards can result from unauthorized modification of the machine. No modification of this equipment is allowed. Any modification to this equipment will void the warranty.

Validation Option

Medisafe (UK) can also provide a Validation Service to address the essential local

regulation requirement. The work will be carried out by authorised Medisafe engineers to ensure your PCF Pro continues to conform to local and national guidelines.

For more information on service or any of these options, please contact Medisafe or your regional distributor.

It is expected that any person servicing or repairing the PCF Pro will be a competent engineer with an understanding of electrical safety, and knowledge of three phase power. It is also crucial to understand the risks of working with electrical appliances that use water. Caution must be taken at all times to ensure a safe environment.

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2. Installation

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Transport and Storage

The permissible environmental conditions for transport and storage of a new or used PCF Pro must adhere to the environmental conditions for altitude, temperature and relative humidity.

Marking

The markings on the packing crate stipulate the machine’s storage conditions and handling information.

Keep dry

This way up’

Environmental

This equipment can be transported and stored safely, in the following environment:

Temperature Range: +2°C to +60°C

50kPa to 106kPa

Pressure range

Humidity range 30% to 90% RH (Non-condensing)

Lifting

Lifting and manoeuvring the PCF Pro in its packing crate must be done using a pallet truck or forklift truck able to take a load in excess of 550kg. Ensure that the forks are evenly spaced, and central to the machine as shown:

Beware: The Load pedal and drain outlet is vulnerable at this stage. Care must be taken not to knock or crush it with the forks, as this could result in irreparable damage to the drain and tank assembly.

Unpacking

Retain all packaging materials, if for any reason the unit needs to be returned to the supplier, then the original crate and packaging materials should be re-used.

Carefully unpack your PCF Pro by removing the top panel first. The front panel of the packing crate is designed to be used as a ramp to aid in getting the machine off the crate. Once off its base and unpacked, it can then be moved across a level floor on its castors.

This equipment is not intended to be routinely moved, wheels are provided only to facilitate installation and servicing by a service engineer.

Returns

Before transporting a used PCF Pro, it is vital that all fluid is thoroughly drained from the machine. If returning the unit to your supplier or Medisafe UK Ltd it MUST first be fully decontaminated before transporting.

The Decontamination Certificate must also be completed and displayed in a prominent position when returned with the product (see section 3-14-4).

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Enclosures Check List

The unit is supplied with a range of accessories to enable easy installation and efficient operation. 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.

The PCF Pro comes with three baskets, instrument tubing, and distal connectors for reverse flushing. Replacement items can be ordered, see below list for details.

Note: The below depends on your machine type, please refer to what has been specified on your order.

PCF Pro Accessory Kit (MP21223)

Quantity Part No. Description

1 HOSE002 Standard Washing Machine Hose – Blue

2 HOSE007 Stainless Steel Hose Assembly – Red Indicator

3 MP21225 PCF Pro Plumbing Kit

2 MP21224 Chemical Intake Tube

4 MED8558 Jubilee Clips (50-70mm)

1 MP21006 Elbow Drain Accessory E90-54 (54mm I/D)

1 MP21007 Drain Tube Accessory 54mm O/D x 2mm wall (1m)

1 MP20908 54mm Drain Hose (200mm)

PCF Pro Plumbing Kit (MP21225)

Quantity Part No. Description

2 MED1246.5.0 Distal Connector Box of 10 mixed

20 MP21226 Elbow Hose & Luer (240mm)

Checklist ✔

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Additional Accessories

A range of Medisafe approved accessories including replacement parts and consumables, may be purchased from your supplier. The use of these compatible Medisafe approved products will ensure the continued and reliable operation of your machine.

Note: 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.

Printer

Part No. Description

MED1014B Thermal printer including power supply, paper and USA plug

MED1014C Thermal printer including power supply, paper and European plug

MED1014F Thermal printer including power supply, paper and Australian plug

MED1014G Thermal printer including power supply, paper and UK plug

MED1014M Thermal printer including power supply, paper and South Africa plug

MED1014.1 Thermal printer paper (1 x 25m roll)

MED1017

Approved Chemicals

Part No. Description

MED7701 EDA+ 10L Bottle

MED8037 3Ezyme 10L Bottle

Printer Serial Data Cable

DB9 Male to Female Straight through

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Machine Position

see

Ambient Lighting

500 Lux minimum room lighting

<1.8m from power cable exit. (Rear lower left of unit)

precautions regarding EMC and needs to

Installation Requirements

Level floor and at least 150mm (6in) away from surrounding walls for ventilation (

Site

Mains Supply

Cables shall be rated for maximum current of the equipment, meeting the requirements of IEC 60227 or IEC

60245. The PCF Pro is supplied with 2m of screened power cable.

200 - 230Vac 60Hz Models (only)

Power cable which must be wired using a plug and socket, conductors colour coded as follows:

• Live 1 Black

• Live 2 Black

• Live 3 Black

• Earth Green/Yellow

section 2-9 for dimensions and clearances).

There should be enough free space provided near the machine for safe and efficient

maintenance in the future.

For all Other Models

Power cable must be permanently installed by wiring directly into a switched wall panel. Under no circumstances should it be wired using a plug and socket. Conductors colour coded as follows:

• Live 1 Brown

• Live 2 Black

• Live 3 Grey

• Neutral Blue

• Earth Green/Yellow

The cable must be protected with a 3phase Residual Current Device (RCD) and Miniature Current Breaker (MCB). The RCD and MCB shall only be used to supply this equipment.

The disconnect switch must:

• Isolate all poles simultaneously

• Be lockable in the off position

• Comply with standards IEC/EN 61058-1 and IEC 60447 (creepage and clearances for 4kV transient

voltage)

• Be situated close to the equipment for ease of accessibility, and in a position where the operator can turn it off in an emergency without leaning over the machine.

• Marked as the disconnection device for this equipment

• Disconnect device off-position should be clearly marked (O) and the on-position should be marked (l)

To avoid risk of electric shock, this equipment must only be connected by a fully qualified electrician and to a mains supply with a protective earth.

Supply Voltage

See section 5-1

Position of supply

Electro Magnetic Compatibility (EMC)

If >1.8m please advise

Medical electrical equipment needs special be installed and put into service according to the EMC information provided in the Appendix

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Water Supply

Water Hardness

), Quality & Purity

<125ppm with water quality and purity tested and approved for Disinfection as per

Pressure

2 – 5 bar (

) for all water supplies

RO Water 5 – 80°C (

)

1x shut valve with ¾in BSP male thread for hose tail (

)

Position

Within 1m (40in) of proposed installation

Drainage System

Type

Gravity

Drain entry and the entire drain hose must be below the machine drain outlet

Internally connected within the machine to the drain pipe, downstream of the drain

Effluent Temp

95°C (

)

Compressed Air Supply

Pressure

5.5 – 7 bar (80 – 100 psi)

If medical grade compressed air is not used, an Eliminizer needs to be included at

Printer

Position of printer

Within 1m (

) from the machine, where it will not be affected by spillage, leakage

(CaCO

Flow Rate 12 – 30 l/m (3 – 8 US gal/m)

Temperature:

Connection

EN ISO15883-1:2009 (item 6.4.1 and 6.4.2)

30 – 70 psi

Cold Water 5 – 30°C (41 – 86°F)

Hot Water 50 – 80°C (122 – 140°F)

41 – 140°F

1x shut valve with ¾in BSP male thread for hose tail (Cold water)

1x shut valve with ¾in BSP male thread for hose tail (RO water)

Drain Connection

Position

Capacity > 180ltr/m (47.5 US gal/m)

54mm (2.125in) OD outlet from machine

Drain must be fitted with suitable traps

Drain gulley pipe ID at least 100mm (4in) to conform with EN ISO15883

Hot water

Overflow

Quality

Connection 8mm (0.315in) dia. Quick fit hose connector

valve

203°F

time of order

Dimensions W:230mm (9in) x D:280mm (11in)

Position

Supply Connection 90 - 230Vac 50/60Hz (single phase).

power supply

Above or to the side and at least within 1m (40in) from the machine, where it will not

be affected by spillage, leakage or condensation from the equipment.

40in

or condensation from the equipment.

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Connecting the PCF Pro

Note: Medisafe (UK) Ltd. recommends this product be installed & commissioned by Medisafe (UK) Ltd (or suitably qualified personnel).

1. Unpack the machine and position it within 1m of the mains power supply, drain, and mains water supplies.

2. Identify the drain hose supplied with the unit. Connect the hose to the drain outlet underneath the right hand side of the unit.

3. Secure the drain hose to the machine using the supplied jubilee clip, and cut to length. Refer to the drain connection diagram in section 2-9-3 for connection options.

4. Connect the machine drain to the site drain.

5. Connect the compressed air hose to the 8mm connector on the lower rear of the unit.

6. Identify the blue cold-water hose supplied with the unit. Ensure the seal in the hose end is in place and screw the elbow connector onto the cold-water inlet at the lower rear of the unit.

7. Connect the straight end of the hose to a suitable cold water supply.

8. Identify a stainless steel water hose supplied with the unit. Ensure the seal in the hose end is in place and screw the elbow connector onto the cold-water inlet at the lower rear of the unit.

9. Connect the straight end of the hose to a suitable hot water supply.

10. Repeat for the RO water if this has been made available on site.

11. Turn on the water supplies and check for leaks.

12. Fit the shorter of the kick plates to the machines side, ensuring the nut insert faces the front of the machine.

14. Move the machine into its final position, ensuring the castors are aligned front to back, and apply the front castor brakes

15. Fit the front kick plate over the load switch, ensuing the switch operates. Screw the front kick plate to the machine, and fit the rubber hole covers.

16. Connect the machine to the electrical mains supply (see section 2-7)

17. Apply power to the machine and open the lid (see section 3-7-6)

18. Fit the tank filter ensuring it is inserted flat into the tank recess.

13. Screw the side kick plates to the machine, and fit the rubber hole covers.

19. Check carrier lift, emergency stop and

20. Carry out the commissioning procedure

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safety edge operation (see section 3-7-10)

defined within the PCF Pro Service Manual.

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Installation Drawings

Rear View Showing Services

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Front View

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Left Side View with Lid Closed showing Drain Connection

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Left Side View Lid Open

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Connecting to the RS232 Port

Thermal Printer

21. Identify the RS232 Data Cable supplied, and plug the correct end into the socket located at the lower right hand side at the rear of the unit.

22. Connect the other end of the RS232 data cable into the connector on the rear of the thermal printer.

Data Logging PC

Wash cycle data is sent from the serial port to a printer, however, as an alternative data may be sent to a logging device or computer via the serial port using a serial data logging program of your choice.

Note: Only IEC/EN60950-1 certified equipment should be connected.

Connect a suitable RS232 Null modem cable between the data port on the rear panel and a COM port on your PC. Run your serial data logging program, ensuring it is configured in the following manner:

• Baud Rate – 19200bps

23. Plug the printer power supply cable into the rear socket of the printer, and connect the mains power cable into a suitable mains supply outlet, then switch on the printer.

Note: When the printer paper shows red stripes, this indicates the paper is about to runout, and must be replaced. Once the paper has been changed press the online button, the green led will illuminate and printing will resume.

The printer can store more than 10 cycles in memory when the paper has run out. If the power is not removed when changing the paper, the stored cycles will be printed after the paper has been changed.

• Data Bits – 8

• Parity – none

• Stop Bits – 1

• Flow Control – none

• Handshaking – off

• Buffer size > 500

• Append line feed to cartridge return

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3. Operation

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The PCF Pro is controlled using a touch screen menu. The scroll arrows are used to cycle through the menu pages.

Menu Functions

Start

Wash Program Set the selected wash program

Chemical 1 Prime chemical pump 1

Chemical 2 Prime chemical pump 2

Clock Set the time and date

Data Logging

Information

Start the automated cycle

sequence

Download logged cycle data

onto a USB Flash Drive

Serial number, cycle count and

software version

Supervisor Menu

Carrier

Note: When the PCF Pro has been idle for 10 minutes the screensaver will start, touch the display to exit.

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View and Edit Program

Parameters

Controls to raise and lower the

Carrier Lift

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Power Up

Turn on the power to the machine using the isolation switch on the wall.

When the machine is turned on, it conducts a Power-On Self-Test (POST) to ensure the machine is ready for use.

This process takes a few seconds to configure the machine and check the basic operation of the control system, memory and sensor interfaces.

Authorisation code

This is an optional feature, which can be enabled by a service engineer. When enabled, the user is required to enter a four-digit PIN number to unlock the user control panel. A valid PIN entry identifies the user and their operator number is shown on the cycle printout. There are 80 operator numbers each with a unique PIN number, see Appendix 6-7 for details.

Before the carrier lift system can be used, it must zero its position sensor. If the machine was powered off and the carrier lift was not fully open or closed, then the display will show:

Press and hold until the carrier lift is fully open.

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Setting Time & Date

The time and date must be set correctly to ensure the accuracy of the cycle records, and MUST be periodically checked by the user. There is no automatic provision for daylight saving hours. While the machine is off, a backup battery maintains the time and date.

Set Time

Set Date

1. Use the scroll arrows to cycle

through to the clock icon

2. Press Set Time

3. Use the arrows to adjust the

Hours, Minutes and Seconds

1. Use the scroll arrows to cycle through to the clock icon

2. Press Set Date

3. Use the arrows to adjust the Date, Month and Year

4. Press to return to the main menu

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Express Deluge Wash

da Vinci Wash Cycle

Cannulated Instruments General

da Vinci Disinfect Cycle

Pre-wash Chemical

190 0 0 0 0 0 Pre-wash Time

Minutes

3 3 3 3 3 3 Wash Chemical 1

ml 0 0

1000

Wash Temperature

ºC 0 0

Degas

Minutes

0 0 3 3 3 3 Wash Time

Minutes

0 0 20

Rinse Chemical 1

ml 0 0 0 0 0 0

Rinse Temperature

ºC

60 0 60

Rinse Time

Minutes

2 0 2 1 1

Rinses

- 1 0 2 1 2 2

Disinfection Temperature

ºC

91 0 91

Disinfection Time

Minutes

0 3 1 3 3 3 Typical Total Cycle Time

Minutes

101

Selecting a program

The PCF Pro is installed with six pre-programmed wash cycles during manufacture. When starting a cycle, the machine will use the currently selected program. To change the selected program, prior to initiating a cycle:

1. Use the scroll arrows to cycle through to the Wash program icon

2. Change the selected program with the

+ and – buttons

Standard Program Parameters

Program Number

Parameters Units

Disinfect Only

Inst. Mild Alkaline

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Caution

Warning

Chemical Handling

Users must read this section prior to any chemical handling.

• Detergents are caustic and can cause adverse effects to exposed tissues. Do not get in eyes, on skin or attempt to ingest by mouth

• Wear appropriate Personal Protective Equipment (PPE) whenever handling chemicals or servicing chemical injection pumps and lines. This should include plastic gloves, goggles or full-face visor, and disposable plastic apron

• Wear appropriate PPE whenever removing baskets or parts from cleaning chamber

• In case of body contact with chemical, always follow emergency procedure given in that

chemical’s MSDS or call emergency services

• Guidelines to be followed in case of emergency caused by chemical contact should be prominently displayed near the machine

• Use a funnel when transferring any chemical from one container to another

Chemical Consumption

A 10-litre detergent bottle will give between eight and eleven washes. The machine weighs the chemical to detect when there is insufficient chemical to run a cycle, prompting the user to replace the bottle before the cycle begins.

Chemical Replacement

The two centre doors allow access to the chemical storage compartment, where the pickup connections are located. The pickup tube for chemical 1 is on the left, and chemical 2 is on the right.

Disposal of chemical containers

For the correct disposal of chemical containers, please refer to the manufacturer’s instructions and local regulations.

Chemical Priming

When changing an empty detergent bottle, to prevent unnecessary cycle errors the system should be primed to ensure chemical fills the entire hose, from the supply to the tank.

1. Remove the empty container

2. Place the new container in the tray

3. Check intake hose filter is clear of debris

4. Place the intake hose in the container, ensure any spillages are cleaned up

Chemical bottles must be connected to the correct port. Otherwise, wash efficiency and/or rinsing will be

compromised. Ensure that the chemical type matches the port shown on the display.

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5. Use the scroll arrows to cycle through to the relevant Prime

Chemical Pump icon or

6. Press Prime Chem. Pump to start the chemical pump

7. When chemical can be seen entering the tank, press Prime Chem. Pump again to stop the pump

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Baskets

The PCF Pro has three baskets, which are used to house DIN baskets. Easily placed into and removed from the machine, the baskets are held in racks on three levels and dock onto water supply spigots at the rear of the rack. To prevent the baskets moving during operation they are locked into position with securing flags.

Basket Removal

To remove the basket push the thumb ball up on both sides of the rack. The flags will drop down allowing the basket to be pulled out of the rack.

Basket Insertion

To insert the basket, place it on the white guide rails and push it back

Pull the basket away from the machine, and tilt down to ensuring any retianed water drips into the tank.

ENSURE the basket docks onto the irrigation spigots

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detached from the

during processing, they should be reprocessed ensuring that the Luer

Check the condition of

irrigation port Luer

Luer connector

Luer connector clip

Luer pipe

Push up the locking flags

ENSURE the thumb ball latches in the down position before moving the carrier lift

In general, the luer pipes should be replaced every 12 months. However, depending on use of the machine, the luer pipes may require replacement sooner than 12 months.

The user must inspect the luer pipes before every use and replace if required.

Note: Replace all luer pipes at the same time.

• Do not allow Luer pipes to protrude from the basket.

• If any instruments became

Medisafe connection tubing

Caution

The luer pipe clips into the luer connector.

connection is firmly seated.

• basket hoses, ensure they are not kinked or ruptured.

Luer pipes

The PCF Pro basket comes with luer pipe connections. Luer pipes are connected to these connections for cleaning of lumen instruments.

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To remove the luer pipe, press the luer connector clip.

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Luer pipe disconnects

Lift luer pipe to remove

The luer pipe disconnects from the luer connector as below.

Remove the luer pipe by lifting it away from the luer connector.

Instrument Loading Precautions

When loading instruments into a basket observe the following precautions:

• Do not place items directly into the wash tank or allow them to make contact with the tank sides.

• Do not load basket with instruments pointing at the lid.

• Do not overload the basket, maximum load of 10kg (22lbs) per basket.

• Do not allow Luer pipes to protrude from the basket.

• Always use a Full DIN Tray Standard to hold instruments (M20044).

• Always attach tubing to a suitable size distal connector for instruments being cleaned or to a quick connect port if the instrument has one.

• Always open box jointed instruments.

• Always ensure taps are open on

cannulated instruments.

• Always dissemble instruments that are designed to be taken apart.

Instruments

Each basket is equipped with twenty ports for maximum pressure irrigation. These are divided equally between each side to prevent crossovers or shadowing of instruments.

When selecting Instruments for the PCF Pro:

• Always confirm compatibility with the instrument manufacturer.

• Always follow the manufacturer’s instructions if processing instruments with special characteristics e.g. fibre optics or rigid optics.

• Whether pre or post processing instruments, Always follow the manufacturer’s instructions.

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Carrier Lift Controls

Use the scroll arrows to cycle through to the carrier lift icon.

Press and hold to index the carrier lift up to the next level

Press and hold to index the carrier lift down to the next level

Press and hold to open the carrier lift without stopping at each level

Press and hold to close the carrier lift without stopping at each level

Safety Edge

To protect the operator from crush injury a Safety Edge pressure activated strip circles the tank perimeter.

If the safety edge is pressed, the carrier lift will stop and a message will be displayed:

Pinch points are created during lid articulation. Keep hands clear when opening or closing the lid.

Light Guard

To protect against accidental damage of the baskets and Lifting system, a light beam sensor monitors for obstruction along the front of the Carrier Lift. If this beam is broken (i.e by instruments, baskets or basket flags) the carrier lift will stop and a message will be displayed:

Note: If the Carrier Lift was travelling down when a fault is detected, to release an obstruction it will stop, reverse, travel up a few centimetres and stop.

Once the obstruction is removed from the light guard path, the machine will allow the Carrier Lift to be operated again.

To allow the Carrier Lift to be operated again, remove the obstruction and press Reset Safety Edge on the display.

Emergency Stop

In the unlikely event of an uncontrolled fault, the emergency stop button can be pushed to cut power to the Carrier Lift and other critical outputs.

When the emergency stop is pressed, the machine will display an error message and abort a cycle if one was running (see section 3-9-10). Normal operation can only be resumed once the emergency stop button has been pulled out.

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Testing Operation of the Safety Devices

To check operation of the carrier lift:

1. Press and hold to fully open the carrier lift and confirm the display shows:

To check operation of the safety edge:

1. While moving the carrier press the safety edge and confirm the carrier lift stops and the display shows:

2. Press and hold to fully close the carrier lift and confirm the display shows:

3. If the carrier lift system encounters a problem it will be shown on the display:

4. If a carrier limit fault message is shown please contact Medisafe to resolve the fault.

2. Press Reset Safety Edge on the display and confirm the carrier lift can be moved again.

To check operation of the emergency stop:

1. While moving the carrier lift press the emergency stop and confirm the carrier lift stops and the display shows:

2. Pull out the emergency stop button then press OK on the display, and confirm the carrier lift can be moved again.

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Starting a Cycle

The load sequence is optimised for hands free operation using the Load foot pedal to step through an automated sequence:

1. Confirm program selection (to change see section 3-5)

Pinch points are created during lid articulation. Keep hands clear when opening or closing the lid.

2. Press and hold the Load foot pedal until the carrier lift is fully open

Replace chemical(s) (see section 36-2) and press OK to continue, or press Cancel to abort the cycle start

3. Insert the bottom basket into machine and latch (see section 3-7-2)

If there is insufficient chemical to complete the cycle a warning will be shown:

4. Press and hold the Load foot pedal until the carrier lift indexes down to the next level and stops

5. Insert the middle basket into machine and latch (see section 3-7-2)

6. Press and hold the Load foot pedal until the carrier lift indexes down to the next level and stops

7. Insert the top basket into machine and latch (see section 3-7-2)

8. Press and hold the Load foot pedal

until the carrier lift is closed, and the cycle will start

Note: the touch screen controls may be used to bypass the automated sequence (see section 3-7-6)

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Automated Wash Cycle

The automated wash cycle consists of the stages Pre-wash, Wash, Rinse, Final Rinse/Disinfection, Cooling and Drying. Every stage of the cycle is configured by the Program Parameters stored in the machines memory (see section 3-5-1). These parameters allow the cycle to be customised to select the fill water type, skip stages, repeat stages, control temperature set points, set stage duration etc.

During a cycle, the remaining time for each stage will be shown on the right hand side of the display, and the temperature/pump pressure on the left.

Cycle Process

• Lock Lid The lid is sealed shut to prevent entry during the cycle

Start Cycle

• Fill Fill tank with cold water to the minimum level

• Cyclin g For a set pe riod alternate between spray arms (45s) and lumen flushing (15s), heating up to 35°C

Pre-wash

• Drain Drain until tank is empty, then for a further 20s

Wash

Rinse

Final Rinse /

Disinfection

Cooling

Drying

• Fill Fill tank with cold and hot water mix up to the top level

• Dose Detergent is added once the mini mum tank level is reached

• Heat Heat water to the set point, circulating through the lumens and spray arms

• Degas Pulse ultrasonics on and off for the degas period, with no recirculation

• Cyclin g Alternate between ultrasonics (45s) and lumen flushing (15s) for a set period

• Drain Drain until the tank is empty, then for a further 20s

• Fill Fill tank with Hot water upto the minimum level

• Cyclin g For a set pe riod alternate between spray arms (45s) and lumen flushing (15s), heating up to the set point

• Drain Drain until the tank is empty, then for a further 20s

• Fill Fill tank with Hot/RO water upto the minimum level

• Heat Heat water to the set point, circulating through the lumens and spray arms

• Cyclin g For a set period circulate through the lum ens and lid spray

• Drain Drain until the tank is empty, then for a further 20s

• Fill Add cold or RO water run down the back of the tank up to the bottom level

• Drain Continuouslydrai n the tank throughout

• Repeat Repeat the cooling process until cham ber temperature below 60°C

• Drain Drain until the tank is empty, then for a further 20s

• Soft -shot For a set period compressed air is alternately blown through the irrigation ports and spray arms

Cycle

• Confir m Acknowledge cycle complete by pressing unload on the display

Complete

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Pre-wash

All water in the tank is drained. The machine fills with cold water to the minimum level. During filling for each stage, the spray and irrigation valves are opened, and the pump is operated at least once to ensure all voids are filled.

The machine then washes for a set time, alternating between spraying and flushing.

Wash

The tank is filled to the top level with a mix of hot and cold water to attain the set temperature. Once the water reaches the midlevel, a quantity of detergent is dispensed into the tank. The pump is pulsed on and off to even out the temperature, fill all cavities, and to mix the chemical thoroughly.

Once the tank is full, if the temperature is below the set point, the water heater will turn on.

During flushing recirculated water is pumped through the instruments.

Finally, all water in the tank is drained

When the set temperature is reached, the ultrasonics degas the tank by pulsing on and off for a pre-defined time to remove any dissolved air.

At the end of the degas period the machine will then alternate between irrigation and Ultrasonics for a pre-defined time.

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Finally, all water in the tank is drained.

Rinse

The machine fills with hot water to the minimum level.

to the minimum level.

Once the tank is filled, the water heater will turn on to heat the water to the set point.

When the set point is reached, the machine will alternate between Flushing and Spraying for a pre-defined time.

The machine will alternate between Flushing and Spraying for a pre-defined time while heating the water up to the temperature set point.

Finally, all water in the tank is drained.

Final Rinse/Disinfection

The machine fills with hot water (or RO if fitted)

Finally, all water in the tank is drained.

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Caution

Cooling

On completion of the last cleaning stage, the inside of the machine will be hot. To reduce the water vapour and temperature, cold water is cascaded down the back wall of the tank and into the drain a pre-defined time.

Note: this water does not come into contact with the load.

Finally, all water in the tank is drained.

Drying

To aid the drying of cannulated instruments and to remove excess water from manifolds and pipework, compressed air is alternately blown through the irrigation ports and spray arms. This minimises spillage when the baskets are removed from the machine.

Cycle Complete

When the cycle is complete, a sound is played and the LED Edge flashes green.

Confirm cycle record is present and indicates the cycle has completed with no errors.

Unload

The unload sequence is optimised for hands free operation, where the Load foot pedal is used to step through an automated sequence:

1. Press and hold the Load foot pedal until the carrier lift indexes up to the bottom basket and stops

2. Remove the top basket from the machine (see section 3-7-1)

3. Press and hold the Load foot pedal until the carrier lift indexes up to the next level and stops

4. Remove the middle basket from the machine (see section 3-7-1)

5. Press and hold the Load foot pedal until the carrier lift indexes up to the next level and stops

6. Remove the bottom basket from the machine (see section 3-7-1)

If any instruments became detached from the Medisafe connection tubing during

processing, they should be reprocessed ensuring that the Luer connection is firmly seated.

7. The machine is now ready for the next cycle

Note: the touch screen controls may be used to bypass the automated sequence (see section 3-7-6)

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Re-Wash Cycle

The PCF pro can be configured with a re-wash program - a water and time saving feature. This allows the wash water and chemical to be reused. At the end of the wash, the user is allowed to open the lid, add new instruments, and repeat the wash stage using the same water up to ten times.

Note: if the water temperature exceeds the set point by more than 10°C the cycle will be aborted (see section 3-9-10).

At the end of a wash stage press Yes on the screen to reuse the water again.

Press Reload Complete on the screen to begin another wash stage

To end the re-wash process, once the wash stage is complete press No on the screen to drain the water and end the cycle.

Unload the instruments (see section 3-9-9) then load more instruments for cleaning (see section 3-8).

Temperature of the water within the unit can reach 60°C (140°F), when opening the lid and reloading instruments take care and wear appropriate PPE.

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Cycle Errors

If an unexpected condition occurs during a wash cycle (i.e. low pump pressure, low water temperature, see section 4-1 for a full list) the system will abort the cycle and report an error.

When an error occurs during a cycle the load may still be contaminated, and will still require processing. Check the printout to see if the cycle completed before the error, if it did not then repeat the cycle to attempt to reprocess the load. If the error persists use another machine or alternative cleaning and disinfection process (according to facility procedure), then contact a service engineer to repair the machine.

If an error occurs:

• An audible alarm will sound

• The LED Edge will flash red (see

section 3-12)

Once the tank is drained, the machine will be reset and return to the main menu.

Aborting a Cycle

While running a cycle in the PCF Pro, it may be necessary to end (abort) the cycle operation before scheduled completion, because of a unit problem, wrong load, etc.

To abort a c ycle press in the top left corner. This will pause the cycle, press Abort to confirm or press Resume to continue the cycle.

• An error code and description will be shown on the display:

• The printer will output the Error code, description, and diagnostic information

Acknowledge the error by pressing OK.

If the tank is not empty, the water will be automatically drained to allow access to the load.

If the cycle is aborted, a cycle error will be generated (see section 3-9-10)

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LED Edge

The LED Edge colour status indicator on the lid visually shows the current state of the machine:

Panning Resetting

Blue

Green

Red

Amber Panning Test Mode

Static Idle

Pulsing Cycle Running

Flashing Cycle End

Static Cycle Completed

Flashing Cycle Halted

Static Error

Panning Carrier Lift Moving

Routine Maintenance

Important safety information:

Always ensure mains power is disconnected. Always adhere to the recommended safety

precautions for cleaning products in use.

It is recommended that Personal Protection Equipment (PPE) be worn during loading/unloading, and cleaning or decontaminating the equipment. This must include apron, gloves and eye-protection.

For cleaning internal and external surfaces, a disinfectant cleaner such as Isopropyl Alcohol or a household kitchen cleaner can be used, provided it is marked as a DISINFECTANT cleaner.

In the interests of health and safety, all medical washers should be cleaned on a weekly basis as part of a routine maintenance program. This will ensure the machine is safe for operators and maintenance personnel. To keep your machine operating within its design parameters the following checks must be performed on a regular basis. Please note that completion of these checks is not a substitute for regular servicing and maintenance by a suitably qualified engineer.

All maintenance procedures should be carried out in a well-lit environment, recommended minimum lighting level is 500Lux.

Before Every Cycle

1. Visually check that there is enough chemical for the next wash. Replenish as necessary.

2. Clean the wash tank filter:

Ensure the tank filter is correctly replaced such that it is inserted flat into the recess.

3. Check the wash chamber is free from any debris or deposits.

4. Check the spray arms rotate.

5. Remove each basket and check the spray arms for blockage:

Remove the spray arm by first rotating counter clockwise and then pull.

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Caution

Check inside the spray arm and clear any debris.

To ensure correct spray direction the spray arms are handed so they cannot be inserted incorrectly:

6. Check the condition of basket irrigation port Luer hoses, ensure they are not kinked or ruptured.

In accordance to ISO15883, the international standard for the performance of Washer-Disinfectors, we advise the checks stipulated below. However, each hospital may follow its own checks to comply with the applicable standards.

Daily Checks

1. Check that there is sufficient chemical for the days planned use

2. Check and clean all internal surfaces above the water line.

3. Check and clean all external surfaces including lid seal.

4. Check lid and lid seal for any damage.

To replace the spray arm, line up the slot to the internal hub pin, push in and then rotate clockwise:

If damage is found, please contact a service engineer (see section 1-17).

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Caution

5. Check the 4 lid docking seals for any damage.

If damage is found, please contact a service engineer (see section 1-17).

6. Check the six basket docking seals for any damage or debris.

If damage is found, please contact a service engineer (see section 1-17).

7. Check the six basket manifolds for blockage.

Weekly checks

1. Carry out the daily checks.

2. Check water hardness of hot and cold water supplies.

3. Check water conductivity of final rinse water supply.

4. Check condition of mains water

Note: The use of a “Process Challenge Device for Minimally Invasive Surgery” may be required according to your local authority guidelines, and the cleaning indicator manufacturer’s instructions.

Ref:

supply hoses.

5. Visually inspect water and drainage system for leaks.

6. Cleaning efficacy test by residual soil detection

7. Run a full decontamination procedure (see section 3-14).

8. Test operation of safety devices (see section 3-7-10).

EN ISO15883-1:2009

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Decontamination Guide

Decontamination is defined as the cleaning and disinfection of the machine, and is vital to ensure the machine is safe for operators and maintenance personnel.

Important safety information:

Always ensure mains power is disconnected.

Always adhere to the recommended safety precautions for cleaning products in use.

Always work in a well-lit area, recommended minimum lighting level is 500Lux.

It is recommended that Personal Protection Equipment (PPE) be worn during loading/unloading, and cleaning or decontaminating the equipment. This must include apron, gloves and eye-protection.

For cleaning internal and external surfaces, a disinfectant cleaner such as Isopropyl Alcohol or a household kitchen cleaner can be used, provided it is marked as a DISINFECTANT cleaner.

Daily Cleaning/ Procedure

Using a clean cloth or paper towel:

1. Wipe down all internal surfaces above the waterline with your disinfectant, including the inside of the lid and around the seals.

2. Wipe all external surfaces, including around the sides of the doors.

3. Remove any trace of cleaner from internal and external surfaces with a clean wet cloth.

4. Towel dry.

Note: By the nature of its operation, the washer disinfector’s tank is immersed in water during the cleaning/disinfection cycle. Therefore, it should already be clean and disinfected by the end of a cycle.

Full Decontamination

On a weekly basis:

1. Perform the daily cleaning procedure.

2. Fit luers to all basket ports to ensure they are open.

3. Run Program 4 (see section 3-5 and 3-8).

If the machine has been idle for more than a week:

1. Perform the daily cleaning procedure.

2. Fit luers to all basket ports to ensure they are open.

3. To make a 5% disinfectant solution place 1.9 litres (typically) of non-

foaming Sodium Hypochlorite based disinfectant into a shallow heat resistant container. Place the container in the basket (this prevents it

from being drained at the start of the cycle).

4. Select Program 4 (see section 3-5).

5. Start the cycle (see section 3-8).

6. 30 seconds before the Pre-wash stage

finishes, press to pause the cycle.

7. Wait 15 minutes then press Resume

to continue the cycle.

8. Allow the cycle to complete.

Pre Transport Procedure

In the unlikely event of a machine having to be returned to Medisafe for any reason, the following procedure must be carried out:

1. Drained and completely empty of fluid.

2. All external hoses removed.

3. Fully decontaminated prior to shipping,

(irrespective of when it was last cleaned).

4. Accompanied by the relevant signed

Decontamination Certificate (see section 3-14-4).

Note: If due to the nature of any fault present, the unit cannot be run prior to return, the tank/chamber must be decontaminated by hand.

Note: Failure to carry out this procedure will incur an additional charge for a full decontamination.

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Decontamination Certificate

Ensure that all items returned to your supplier are disinfected in accordance with the appropriate hospital procedure for equipment of this type.

When returning this product to your supplier, the form must be completed and attached to the outside of the crate/carton. If it is not visible, the courier and/or your supplier can refuse to handle this product.

DECONTAMINATION CERTIFICATE

Promoting a Clean and Safe Service

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Downloading the Cycle Log

The PCF Pro contains on board memory, which holds a record of every cycle run on the machine. This Log can be downloaded to a USB flash drive via the USB Data port located in the chemical cabinet on the right hand side of the machine.

Download Logs

1. Use the scroll arrows to cycle through to the log icon.

2. Insert the USB flash drive into the USB data port.

Note: the flash drive must be formatted as FAT32.

3. Press All Logs to download all cycle logs, or New Logs to download the cycle logs since the last download.

4. Wait for the logs to be downloaded to the USB drive. Do not remove the USB Drive while downloading, as this could corrupt its contents.

5. Once the log files have been downloaded remove the USB drive and press OK.

6. A file for each cycle will be stored in the USB drive directory:

MEDISAFE\<machine serial number>\<cycle range>\<cycle number>.txt

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4. Troubleshooting

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This section of the manual describes the types of PCF Pro problems which may occur, and indicates probable causes/corrections.

If the situation cannot be corrected following the Troubleshooting Solutions, repeating the cycle, or if a problem occurs which is not described, then please contact Medisafe. Service charges may be incurred, consult your warranty for details. A trained service technician will promptly place your PCF Pro in proper working order.

NOTE: Never permit unqualified persons to service the system. If a system problem cannot be corrected using this section, please contact Medisafe.

Calling for Service: First, try to define the situation and determine whether it can be solved (see section 4-1 and 4-2). If the situation cannot be solved, call Medisafe and provide the following information:

• A description of the fault

• Model number

• Serial number

• A copy of the printout showing the error

Error Messages

Error Code

Error Message Possible Causes and Solutions

Mains Power Removed Check mains supply to unit was not interrupted during a cycle

Chamber Overflow

Drain Timeout

Chamber Temperature Sensor Mismatch

Chamber Fill Timeout

Chamber Opened Check lid is closed

Temperature Set Point Not Maintained

Chamber Water Level Low

Switch the machine off then on again, if the problem persists turn the machine and the water supply off and call a service engineer

Check tank filter clear, ensure drain is not blocked Check that genuine Medisafe chemical is being used (EDA+ or 3E- Zyme®)

Repeat cycle

Check water supply(s) to the machine are switched on Check water inlet hose(s) for kinks

Repeat cycle, if the problem persists call a service engineer

Check that a non-foaming detergent is being used Check for leaks

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Chamber Water Heat Rate Low

Chemical Dosing

Repeat cycle Temperature sensor or water heater element failure, please call a service engineer.

Check chemical bottle level(s) and replace if required. Check chemical pickup tube is inserted into the chemical container

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Check the Cold water temperature is not above 35°C

Leave more time between washes for the machine to cool down.

16 17

Check tank filter is clear/clean

Check for leaks

Check baskets are docked properly

Check for leaks

39 40

Check water supply flow rate is sufficient

Repeat cycle

Sonic Cleaning Water Level Low

Check tank filter is clear/clean

Check for leaks

Error Code

18 19

Error Message Possible Causes and Solutions

Chamber Start Temperature too High

Chamber Temperature Out of Range

Level Sensor Invalid Repeat cycle

User Aborted Cycle Repeat cycle

Low Main Pump Pressure

High Main Pump Pressure

Temperature Set Point Exceeded

Compressed Air Absent or Pressure Low

The chamber has not cooled sufficiently since the last wash.

Switch the machine off then on again

Check baskets are docked properly Check basket ports are not blocked Check basket docking seals clean

Check basket ports are not blocked Check basket docking seals clean

Repeat cycle

Check compressed air to the machine is turned on

41 43 45 46

49 57

Sonic Generator Fault Switch the machine off then on again

Maximum Cycle Time Expired

Emergency Stop Pressed

Microcontroller Error Switch the machine off then on again

Internal Ambient Temperature too High

Real Time Clock Read Error Switch the machine off then on again

24V Power Supply Voltage Out of Range

Overfill occurred during cool down process

Low Wash Irrigation Pressure

Check tank filter clear, ensure drain is not blocked

Check for visual leaks

Determine reason why emergency stop was pressed before pulling the button to release

Switch the machine off then check for blockages in the ventilation holes Switch the machine on again after an hour

Switch the machine off then on again

Check tank filter clear, ensure drain is not blocked Repeat cycle

Check baskets are docked properly Check basket ports are not blocked Check basket docking seals clean

Unable to Store Cycle Log Repeat cycle

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Other Faults

Problem Possible Causes and solutions

• Insufficient detergent injected. Contact Medisafe

• Check that an approved chemical is being used

Poor Load Cleaning

Water Leaking from Lid Area

Excessive Fill Time

Low Irrigation Port Flow Rate

No Power to Unit or Display is off

• Instrument basket is overloaded. Adjust load

• Instruments are excessively soiled

• Instruments have been left soiled for more than two hours

• Verify facility power meets Unit specifications

• Check instruments are lying flat in the basket and not pointing

up at the lid

• Check lid seal is undamaged

• Check incoming water pressure is above 2 bar (29 psi)

• Check water inlet valve is not blocked (beware of hot water

temperature!)

• Check all connectors are fully inserted

• Clean tank filter

• Check basket manifold ports are not blocked

• Check tank docked ports are not blocked

• Verify facility power meets Unit specifications

• Installation Main disconnect switch is in the OFF position

Turn main disconnect switch to the ON position

• Facility power is incorrect for unit. Correct facility power to meet unit requirements

Access to the load in the event of a power failure or stuck lid mechanism

• Internal Circuit breaker has tripped, contact Medisafe

• The PCF Pro contains a manual override to allow the lid to be

opened, this must be carried out by trained service personnel. Please contact Medisafe.

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5. Technical

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General Specifications

General

Description Medical Device Class IIb

Intended Purpose

Operating Process Ultrasonic activity, Spray Arms and Irrigation Ports

Classifications

Internal and external cleaning of surgical instruments, hollow-ware, and associated products

Class 1 electric shock protection, externally powered

No applied parts

IP rating – IPX0 (refer to BS EN 60601-1, para 6.3)

Not suitable for use in an oxygen rich environment

Mode of operation – intended for continuous use

User Interface

Display TFT Touch Screen

Foot Switch Used for hands free operation of carrier lifting system and cycle start and unload

Lighting

Lid Edge Multi Colour LEDs for visual indication of machine status

Blue LED Loading Illumination

Baskets

Quantity 3 baskets per machine

Two 10-way manifolds per standard basket, one on each end

With ten ports open each manifold outputs produces up to:

Features

3 bar (43.5psi) pressure with a flow rate of 50ml/s

2 Spray arms per basket

Soft-shot – Compressed air irrigation and spray arm water

Robot Instrument Capacity Up to 10 per basket (Total of up to 30)

Din Basket Compatibility

Tray Compatibility Size Length 657mm (25.9in) Width 343mm (13.5in) Height 79mm (3.1in)

Interior Dimensions Length 670mm (26.3in) Width 347mm (13.6in) Height 95mm (3.7in)

Max Load Weight 10kg / 22lb per basket (total 30kg / 66lb)

Full DIN Tray Standard to hold instruments (M20044) –

Length 484mm (19in) Width 253mm (10in) Height 76mm (3in)

Carrier Lift

Electrically actuated carrier lift

Features

Guided slide lock system, with retaining flag

Safety Edge strip and light beam for obstruction detection

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Ultrasonics

Typical Frequency 38 to 40 kHz dependant on load

Transducers 84 piezo ceramic

Power 3kW

Pulsed Degas

Features

Electrical Supply

General

MED11180

(380 - 415VAC 50Hz)

MED11180

(200 - 230VAC 60Hz)

Water Supply

Auto-tune

Frequency Sweep

Reflectasonic Technology

Mains supply voltage fluctuations up to ±10% of the nominal voltage;

Transient over voltages typically present on the mains supply (Overvoltage Category II).

Pollution Degree 2

Voltage: 380 - 415VAC 3P+N+PE (Three Phase + Neutral + Protective Earth)

Frequency: 50Hz

Power: 22kW Site Current Capacity: ≥ 30A per phase

Site MCB and Disconnect Switch Current Rating: 40A

Site Wiring Cross-sectional area: 6 mm

Voltage: 200 - 230VAC 3P+PE (Three Phase + Protective Earth)

Frequency: 60Hz

Power: 18kW Site Current Capacity: ≥ 48A per phase

Site MCB and Disconnect Switch Current Ratting: 63A

Site Wiring Cross-sectional area: 10mm

Back Siphonage Protection Integral AB type air gap and weir observing BS EN 1717

Per cycle stage:

• Pre-wash 40lts (10.5US gal)

• Wash 250lts (66US gal)

• Rinse 40lts (10.5US gal)

• Disinfection 40lts (10.5US gal)

• Disinfection Condensate 165lts (43.5US gal)

Consumption

(approximate)

• Cooling 105lts (28US gal)

Total Per supply:

• Cold 288lts (76US gal)

• Hot 247lts (65US gal)

• RO 145lts (38US gal)

Total Cycle 680ltrs (180US gal)

Consumption will vary depending on the cycle selected and the site facilities

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Wash Chamber Liquid Volume

165 Litres (43.5US gal)

Wash Chamber Capacity

223 Litres (59US gal)

Width 925mm (36.4in)

Depth 385mm (15.2in)

Height 530mm (20.9in)

Width 1260mm (49.6in)

Depth 855mm (33.7in)

Height Lid Closed 1106mm (43.5in)

Height Lid Open 1650mm (65in)

Width 1510mm (59.5in)

Depth 1150mm (45.3in)

Height 1500mm (59.1in)

Drainage System

Type Gravity

Drain Connection 54mm (2.125in) OD outlet

Overflow Internally connected within the machine to the drain pipe, downstream of the drain valve

Effluent Temp 95°C (203°F)

Dimensions

Wash Chamber Dimensions

Outer Cabinet Dimensions

Shipping Container Dimensions

Weight

Operational weight (Dry)

Shipping weight 515kg (1135lb)

410kg (905lb)

Chemicals

Storage Integral Chemical cupboard for 2 bottles

Size and Nature of Bottles EDA+ or 3EZyme Fluid: 10L (2.6US gal) plastic bottle

Quantity Used per Cycle EDA+:1000ml (34fl.oz US) or 3EZyme:1380ml (47fl.oz US)

Environmental conditions

Use Indoor, Altitude up to 2000m (6562ft)

Ambient Operating Temperature 5°C - 40°C (41°F - 104°F)

Humidity

Noise Max SPL 69dBA @ 1m from the front of the machine

Maximum relative humidity 80% for temperatures up to 31°C (87.8°F) decreasing linearly to 50% relative humidity at 40°C (104°F)

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Real Time Clock Battery

Type CR1220 (5012LC)

Typical Capacity 35 - 40 mAh

Standard Discharge Current 0.1 mA

Range and Accuracy

Measurement range 2Cº to 98Cº (36ºF to 208ºF)

Water Temperature

Time Displayed in minutes and seconds, accuracy ±0.5sec

Internal Data Storage

Type Micro SD FLASH Card

Typical Capacity 4GB (1 Million cycles)

Displayed and printed to the nearest ºC or ºF accuracy ±0.5ºC or ±0.9ºF Max water temperature: 95ºC (limited by software and thermal trip)

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1: General principles for design

requirements

MDD 93/42/EEC

Medical Device Directive

treat medical materials

and essential performance

devices

PD IEC/TR 60878:2015

Graphical symbols for electrical equipment in medical practice

PD 5304:2014

Guidance on the safe use of machinery

workers to the risks arising from physical agents (noise)

Applied Standards

Standard Description

2006/42/EC Machinery Directive

ISO 13849-1:2006

Safety of machinery - Safety-related parts of control systems -- Part

ISO 13849-1:2012

BS EN 60204-1:2006+A1:2009

BS EN ISO 15883-1:2009 +A1:2014

BS EN ISO 15883-2:2009

BS EN 61010-1:2010

BS EN 61010-2-040:2015

BS EN 60601-1-6:2010+A1:2015

BS EN 60601-1:2006 +A12:2014

BS EN 60601-1-2:2007

BS EN 62366-1:2015

Safety of machinery - Safety-related parts of control systems -- Part 2: Validation

Safety of machinery. Electrical equipment of machines. General

Washer-disinfectors. General requirements, terms and definitions and test

Washer-disinfectors - Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc.

Safety requirements for electrical equipment for measurement, control, and laboratory use

Particular requirements for sterilizers and washer-disinfectors used to

Medical electrical equipment. General requirements for basic safety and essential performance

Medical electrical equipment. General requirements for basic safety

Medical electrical equipment. General requirements for basic safety and essential performance. Collateral Standard. Electromagnetic disturbances. Requirements and tests

Medical devices. Application of usability engineering to medical

BS EN ISO 13485:2012 Medical devices - Quality management systems

BS EN ISO 14971:2012 Medical devices - Application of risk management to medical devices

BS EN 1717:2000

EN 61326: 2013

2003/10/EC

2009/104/EC

Protection against pollution of potable water in water installations and general requirements of devices to prevent pollution by backflow

Electrical equipment for measurement, control and laboratory use. EMC requirements. General requirements

Minimum health and safety requirements regarding the exposure of

Minimum safety and health requirements for the use of work equipment by workers at work

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6. Appendices

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EMC

EMC & Electromagnetic Compatibility Data

Instructions/Notes regarding the PCF Pro and Electromagnetic compatibility (EMC) testing to EN60601-1-2:2007

The PCF Pro has been tested regarding its ability to operate in an environment containing other electrical/electronic equipment (including other medical devices).

The purpose of this testing is to ensure that the PCF Pro is not likely to adversely affect the normal operation of other such equipment and that other such equipment is not likely to adversely affect the normal operation of the PCF Pro.

Despite the testing of the PCF Pro that has been undertaken, normal operation can be affected by other electrical or electronic equipment. Portable and mobile RF communications equipment can affect medical electrical equipment.

As the PCF Pro is medical equipment, special precautions are required regarding EMC.

It is important that the PCF Pro is configured and installed/put into service, in accordance with the instructions/guidance provided herein and is used only in the configuration as supplied.

The PCF Pro may be supplied with the following accessories: serial data cable (MED1017) and thermal printer (MED1014.1)

The PCF Pro’s data cable must be restricted to less than 3m in length and should not be extended by the user. If the PCF Pro is used with adapted cables or cables other than those supplied, this may result in increased emissions or decreased immunity of the PCF Pro, in relation to EMC performance.

If the PCF Pro’s is used with a printer other than the one supplied this this may result in increased emissions or decreased immunity of the PCF Pro, in relation to EMC performance.

It should be noted that the cables provided with the PCF Pro should not be used on other equipment. To do so may result in increased emissions or decreased immunity of the other equipment in relation to EMC performance.

The PCF Pro should not be used adjacent to or stacked with other equipment. If adjacent or stacked use with other equipment is necessary, the PCF Pro and the other equipment should be observed / monitored to verify normal operation in the configuration in which it will be used.

For the purposes of EN60601-1-2, the PCF Pro has an essential performance as follows:

Functions within the operating cycle should continue to operate as normal, and the product should complete its operating cycle correctly.

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Guidance and Manufacturer’s Declaration – Electromagnetic Emissions

Electromagnetic Emissions

The PCF Pro is intended for use in the electromagnetic environment specified below. The

customer or the user of the PCF Pro should assure that it is used in such an environment.

Emissions test Compliance Electromagnetic environment - guidance

RF emissions

CISPR 11

Group 1

The PCF Pro uses RF energy only for its internal

function. Therefore, its RF emissions are very low

and are not likely to cause any interference in

nearby electronic equipment.

RF emissions

CISPR 11

Harmonic emissions

IEC 61000-3-2

Voltage fluctuations /

flicker emissions

IEC 61000-3-3

Class A

Not Applicable

The PCF Pro is suitable for use in all

establishments other than domestic and those

directly connected to the public low-voltage power

supply network that supplies buildings used for

domestic purposes.

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Guidance and Manufacturer’s Declaration – Electromagnetic Immunity

Electromagnetic Immunity

The PCF Pro is intended for use in the electromagnetic environment specified below. The customer or

the user of the PCF Pro should assure that it is used in such an environment.

Immunity test IEC 60601 test level Compliance level

Electrostatic discharge

(ESD)

IEC 61000-4-2

Electrical fast transient /

burst

IEC 61000-4-4

Surge

IEC 61000-4-5

Voltage dips, short

interruptions and voltage

variations on power supply

input lines

IEC 61000-4-11

± 6 kV contact

± 8 kV air

± 2 kV for power supply

lines

± 1 kV for input / output

lines

± 1 kV line(s) to line(s)

± 2 kV line(s) to earth

<5% U

(>95 % dip in U

0.5 cycle

40% U

(60 % dip in U

for 5 cycles

70 % U

(30 % dip in U

for 25 cycles

<5% U

(>95 % dip in U

) For

)

) For 5

± 6 kV contact

± 8 kV air

± 2 kV for power supply

lines

Input / output line tests

are not applicable.

± 1 kV differential

mode

± 2 kV common mode

Not Applicable

(Rated input current

>16A per phase)

Not Applicable

(Rated input current

>16A per phase)

Not Applicable

(Rated input current

>16A per phase)

<5% U

(>95 % dip in U

) For 5

Electromagnetic environment - guidance

Floors should be wood,

concrete or ceramic tile. If floors

are covered with synthetic

material, the relative humidity

should be at least 30%.

Mains power quality should be

that of a typical commercial or

hospital environment.

Mains power quality should be

that of a typical commercial or

hospital environment.

Mains power quality should be

that of a typical commercial or

hospital environment. If the

user of the PCF Pro requires

continued operation during

power mains interruptions; it is

recommended that the PCF Pro

be powered from an

uninterruptable power supply or

a battery.

Power frequency

(50/60Hz) Magnetic field

IEC 61000-4-8

3 A/m 3 A/m (50Hz only)

Note: UT is the A.C. mains voltage prior to application of the test level.

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If incorrect operation occurs,

it may be necessary to

position the PCF Pro further

from sources of power

frequency magnetic fields or

to install magnetic shielding.

The power frequency

magnetic field should be

measured in the intended

installation location to

assure that it is sufficiently

low.

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the user of the PCF Pro should assure that it is used in such an environment.

a. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land

Guidance and Manufacturer’s Declaration – Electromagnetic Immunity

The PCF Pro is intended for use in the electromagnetic environment specified below. The customer or

Immunity test

Conducted RF

IEC 61000-4-6

Radiated RF

IEC 61000-4-3

IEC 60601 test

level

3 Vrms

150 kHz to 80 MHz

3 V/m

80 MHz to 2.5 GHz

Compliance

level

3 Vrms

150 kHz to 80 MHz

3 V/m

80 MHz to 2.5 GHz

Electromagnetic environment guidance

Portable and mobile RF communications equipment should be used no closer to any part of the PCF Pro, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended separation distance (d)

d = 1.2√P

d = 1.2√P 80 MHz to 800 MHz d = 2.3√P 800 MHz to 2.5 GHz

Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m).

Fields strengths from fixed RF transmitters, as determined by an electromagnetic site survey (see Note a) should be less than the compliance level in each frequency range (see Note b)

Interference may occur in the vicinity of equipment marked with the following symbol:

Note 1: At 80 MHz and 800 MHz, the higher frequency range applies.

Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and

reflection from structures, objects and people.

mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the PCF Pro is used exceeds the applicable RF compliance level above, the PCF Pro should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the PCF Pro.

Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

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is intended for use in an electromagnetic environment in which radiated RF

can help prevent

as recommended below,

Rated maximum output power

150 KHz to 80 MHz

d = 1.2√P

80 MHz to 800 MHz

d = 1.2√P

800 MHz to 2.5 GHz

d = 2.3√P

0.01

0.12

0.23

0.1

0.38

0.73 1 1.2

1.2

2.3

3.8

7.3

12 23

Separation Distances Between PCF Pro and Mobile RF Equipment

Recommended separation distances between

portable and mobile RF communications equipment and the PCF Pro

The PCF Pro disturbances are controlled. The customer or the user of the PCF Pro electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the PCF Pro according to the maximum output power of the communications equipment.

Separation distance according to frequency of transmitter

of transmitter

100

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

Note 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range

applies.

Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is

affected by absorption and reflection from structures objects and people.

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Warranty

To ensure continued efficiency and long operational life, your new PCF Pro is covered by a one-year warranty/5,000 cycle 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 PCF Pro”) 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 PCF Pro 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 PCF Pro 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

The Specific Excluded Items

THE SPECIFIC EXCLUDED ITEMS are any items of this new PCF Pro 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: lid seal, CPE ports, O-rings, various types of gaskets and hoses, LEDs (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 the new PCF Pro.

Normal deterioration or damage to plated parts, paint coat, and rubber parts, caused by daily wear and tear and exposure to atmosphere and environment.

Minor irregularities not affecting quality, performance or function of the new PCF Pro 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.

Damage caused by accident, abuse, or negligence of the proper handling as set out in this Owner’s Manual, misuse of the new PCF Pro, use of the new PCF Pro under unusual conditions, and modifications of or to the new PCF Pro or any 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, negligence or Act of God.

Damage to the external casing, wash chamber, load baskets, or any part of the new PCF Pro which may come into contact with the load carrier during the process of loading/ unloading the new PCF Pro.

All charges incidental to breakdowns, such as loss of use of the new PCF Pro, 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 new PCF Pro, 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 final decision on all manufacturers’ warranty claims.

Nothing herein affects the statutory rights of the consumer.

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Serviced by/

Cycles since

Next service

Cycles

Date

Next service

Cycles

Date

Next service

Cycles

Date

Serviced by/

Cycles since

Next service

Cycles

Date

Next service

Cycles

Date

Next service

Cycles

Date

Serviced by/

Cycles since

Next service

Cycles

Date

Next service

Cycles

Date

Next service

Cycles

Date

Serviced by/

Cycles since

Next service

Cycles

Date

Next service

Cycles

Date

Next service

Cycles

Date

Service Record

Medisafe recommend that your PCF Pro be serviced every 3 months in accordance with the schedule contained within the PCF Pro Service Manual, which also contains the technical description of the machine. This record must be completed by the engineer conducting the service and should be made available in the event of a warranty claim or breakdown repair.

Note: No user serviceable parts inside. Service and repair should be referred to trained and qualified persons only - the product supplier (or Medisafe UK Ltd) to avoid personal injury, improper equipment performance, invalidation of the equipment warranty or other costly damage.

3 Month

6 Month

9 Month

Date

last service

due

Date

last service

due

Date

last service

due

Date

last service

due

12 Month

Date

last service

due

15 Month

18 Month

Date

last service

due

21 Month

Date

24 Month

27 Month

Date

last service

due

last service

due

Date

last service

due

30 Month

Date

last service

due

33 Month

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last service

due

36 Month

Date

last service

due

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PCF Pro User Manual

Operator PIN Number Codes

Operator # Pin Operator # Pin Operator # Pin Operator # Pin

1 2040 21 4060 41 6080 61 8020

2 2181 22 4121 42 6141 62 8161

3 2262 23 4282 43 6222 63 8242

4 2363 24 4383 44 6323 64 8343

5 2484 25 4424 45 6444 65 8464

6 2545 26 4565 46 6585 66 8525

7 2626 27 4646 47 6666 67 8686

8 2727 28 4747 48 6776 68 8787

9 2848 29 4868 49 6888 69 8828

10 2989 30 4929 50 6949 70 8969

11 3070 31 5090 51 7030 71 9050

12 3171 32 5191 52 7131 72 9151

13 3292 33 5232 53 7252 73 9272

14 3353 34 5373 54 7393 74 9333

15 3434 35 5454 55 7474 75 9494

16 3535 36 5555 56 7575 76 9995

17 3656 37 5676 57 7696 77 9636

18 3797 38 5737 58 7757 78 9777

19 3878 39 5898 59 7838 79 9858

20 3979 40 5999 60 7939 80 9959

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Symbols Glossary

Conformité Européenne: A conformity marking for certain products sold within the

European Economic Area (EEA) since 1985. The CE marking is also found on products sold outside the EEA that are manufactured in, or designed to be sold in, the EEA. The 4-digit number below the CE mark is the identification number of the notified body involved in the conformity assessment procedure.

WEEE directive: Shows that a product can be recycled separately from other household waste under the WEEE directive

Protective Earth symbol

Standard Hazard Label (used for Warnings and Hazards)

Standard Electrical Danger Label

Standard Crush Hazard Label

Emergency Stop

atory Read - Read this manual before operating this machine

Mand

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