S-8666 , S-8668 and S-8668T User Manual Rev H

Contents

Contents 1 INTRODUCTION... 7 About this manual... 7 Terms used in this manual... 7 Symbols in this manual... 7 Intended use statement... 7 1.4.1 Intended application areas... 8 1.4.2 Intended user... 8 1.4.3 Intended user environment... 8 1.5 Potential misuse... 9 1.6 Product liability... 9 1.6.1 Declaration of Conformity... 9 1.6.2 Disclaimer... 9 1.6.3 Manufacturer... 9 1.6.4 Warranty... 9 1.7 Product labels... 10 1.8 References... 11 1.9 Service life... 11 2 SAFETY... 12 2.1 Safety functions... 12 2.1.1 Door pinch protection... 12 2.1.2 Password protection... 12 2.1.3 Isolator switch... 12 2.2 Safety statements... 12 2.3 General warnings... 13 2.4 Safety labels on the machine... 13 2.5 Personal protection... 13 2.6 Accident or incident reporting... 14 3 DESCRIPTION... 15 3.1 Configurations... 15 3.2 Product description... 16 3.2.1 Control panel... 17 3.2.2 USB (option)... 19 3.2.3 Detergent cabinet... 21 3.2.4 Guides for transport trolley... 23 3.2.5 Lower guide for transport trolley... 23 3.2.6 Outlet for external loading equipment (option)... 24 3.2.7 Guides for external loading equipment (option)... 24 3.2.8 Barcode scanner (option)... 24 3.2.9 Main power switch... 24 3.2.10 Process stop (option)... 24 3.2.11 Door... 24 3.2.12 Electrical outlet (option)... 25 3.2.13 Chamber... 25 3.2.14 Carts... 26 3.2.15 Automatic loading system (option)... 27 User Manual Getinge 86-series

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1.1 1.2 1.3 1.4

Contents 3.3 Control system... 27 3.3.1 Access rights... 28 3.3.2 Navigation and commands... 29 3.3.3 Menu tree... 31 3.3.4 Basic views... 32 3.3.5 Change settings... 35 3.3.6 View system information... 37 3.3.7 Printing... 37 3.3.8 System alerts... 37 3.4 Accessories... 40 3.5 Ambient illumination... 40 3.6 Electromagnetic environment... 40 4 OPERATION... 41 4.1 Before using the machine... 41 4.2 Workflow... 41 4.3 Preparations... 41 4.3.1 Loading the wash cart... 42 4.4 Loading the chamber... 43 4.4.1 Loading the chamber with an automatic loading system (option)... 43 4.5 Starting program... 44 4.5.1 Starting program with a barcode scanner (option)... 44 4.5.2 Starting program with an automatic loading system (option)... 45 4.6 Unloading the chamber... 45 4.6.1 Unloading the chamber with an automatic loading system (option)... 46 4.7 Check cleaning and disinfection results... 46 4.7.1 Handling printouts (option)... 46 4.8 Holding or aborting program... 47 4.9 Change program... 48

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4.10 Preparations for downtime... 48 5 DETERGENTS... 49 6 MAINTENANCE... 51 6.1 Daily maintenance... 51 6.2 Weekly maintenance... 52 6.3 Monthly maintenance... 52 6.4 Maintenance of parts inside the chamber... 53 6.4.1 Maintenance of spray arms... 53 6.4.2 Maintenance of spray arm manifold... 54 6.4.3 Maintenance of strainer... 55 6.5 Removing lime scale deposits in the chamber... 56 6.6 Disinfecting chamber... 57 6.7 Maintenance of the detergent system... 57 6.7.1 Open the detergent cabinet door... 57 6.7.2 Check for damage... 57 6.7.3 Refill detergent... 58 6.8 Maintenance of control panel and stainless steel surfaces ... 58 6.9 Maintenance of printer (option)... 59 7 TROUBLESHOOTING... 60 4 (84)

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Contents 7.1 System alerts... 60 7.1.1 Handle alarms (login required)... 60 7.1.2 Handle warnings... 60 7.1.3 Alarms and warnings list... 61 7.1.4 Handle information message... 68 7.2 General troubleshooting... 70 7.3 Washing efficiency... 71 7.4 Drying efficiency... 71 7.5 Restart the machine... 72 8 HANDLING OF WORN-OUT PRODUCTS... 73 8.1 WEEE directive... 73 8.2 Disposal of detergent or detergent containers... 73 8.3 Disposal of the machine, accessories or spare parts... 73 8.3.1 List of materials... 74 9 ADDRESSES... 75

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Alphabetical index... 77

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1 INTRODUCTION

1 INTRODUCTION This section contains information about the purpose and intended use of the machine. It also explains symbols and labels in the manual.

1.1 About this manual This manual contains important information about usage of the machine. To ensure safe handling and error-free operation, read the manual before using the machine. Pay special attention to section 2 SAFETY. Some sections are not relevant for all machines; options, selections and customizations can vary.

1.2 Terms used in this manual Name

Function/description

Load

Everything that is placed in the chamber, including wash carts and inserts.

Options

Custom choices that are not standard on the machine.

Soiled side

Loading side for soiled load.

Clean side

Unloading side for clean load.

1.3 Symbols in this manual In this manual, warnings and information are indicated by the following symbols. Indicates a hazardous situation that could result in death, personal injury or damage to property if it is not avoided. Points out important details to consider for troublefree and efficient usage of the machine.

The intended use of the 86-series washer-disinfector is to clean, disinfect at a thermally low or intermediate level, and dry surgical instruments (solid and tubular), bowls, basins, glassware, receivers, suction bottles, baby bottles, anesthesia equipment and surgical shoes. The equipment can be made of stainless steel, aluminum, plastic, rubber, silicone or glass. The device is not intended to clean and disinfect invasive devices as end point processing.

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1.4 Intended use statement

1 INTRODUCTION

1.4.1 Intended application areas The washer-disinfector performs the following basic functions: •

Cleaning of medical and laboratory equipment.

•

Disinfection of medical and laboratory equipment.

•

Drying of medical and laboratory equipment.

1.4.2 Intended user The intended users of the 86-series washer-disinfector are operators and service personnel. Operators Operators are clinical personnel, using the machine for its intended use. Typical for this user group is a nurse or assisting nurse at a central sterile services department or personnel at an assistive device center or an animal facility for Life Sciences. The operator must understand the concepts of cleaning and disinfection as part of infection control in the intended use environment. The operator must have knowledge of local routines and requirements. Typical tasks/responsibilities: •

Preparing, loading/unloading items, selecting and starting programs.

•

Daily, weekly and monthly preventive maintenance to be performed by this category.

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Service personnel Typical for this user group is a Getinge technician or a local technician at the facility. Typical tasks/responsibilities: •

Installation.

•

Yearly preventive maintenance.

•

Troubleshooting.

•

Emergency shut downs.

•

Education.

•

End of life and recycling.

1.4.3 Intended user environment The 86-series washer-disinfector is used in facilities such as: hospital wards, Central Sterile Supply Departments (CSSD), Theatre Sterile Supplier Units (TSSU) and hospital laboratories.

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1 INTRODUCTION

1.5 Potential misuse •

The washer-disinfector is not intended for use with household detergents.

•

The washer-disinfector is not intended for cleaning and disinfection of bedpans or urine bottles (ISO 15883-3).

•

The washer-disinfector is not intended for cleaning and chemical disinfection of thermolabile endoscopes (ISO 15883-4).

1.6 Product liability 1.6.1 Declaration of Conformity The product compliance is stated in the Declaration of Conformity.

1.6.2 Disclaimer •

The manufacturer cannot guarantee that the product will work as intended if accessories or spare parts other than those approved by the manufacturer are used.

•

The product liability only applies when the instructions in this manual have been followed in their entirety.

•

The manufacturer accepts no responsibility for personal injuries when the instructions in this manual have not been followed in their entirety.

•

The manufacturer reserves the right to change the specification and design of the product without any prior notice.

1.6.3 Manufacturer This product was manufactured by:

1.6.4 Warranty The product warranty applies in accordance with the agreement reached between the Getinge sales company and the customer.

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Getinge Disinfection AB Ljungadalsgatan 11 352 46 Växjö SWEDEN

1 INTRODUCTION

1.7 Product labels The product labels are attached on the inside of the detergent cabinet. The product model and serial number are important when communicating with Getinge. 12 11 10

REF

XXXXXX

YYYY-MM-DD

SN

WXXXXXXXX

MD

Field text A

9 8 7

Field text B

Field text C

Field text D

Field text E

1 2 3 4 5

Intertek 9700819

16

CERTIFIED TO

CAN/CSA C22.2 No.61010-1,61010-2-040

14 15

LJUNGADALSGATAN 11, 352 46 VÄXJÖ, SWEDEN

CONFORMS TO US UL STD 61010-1, 61010-2-040

6

GETINGE DISINFECTION AB LJUNGADALSGATAN 11, 352 46 VÄXJÖ, SWEDEN

GETINGE DISINFECTION AB

ETL LISTED CM

C

0123

Pressure Temperature COLD WATER 200-600 kPa Max. 20 °C HOT WATER 200-600 kPa 45-60 °C TREATED WATER (optional) 200-600 kPa Max. 60 °C STEAM (optional) 300-500 kPa Max. 160 °C

Designated purpose

9.

Maximum current

2.

Serial number

10.

Date of manufacture

3.

Medical device

11.

Machine model

4.

Voltage alternative

12.

Product listing

5.

Frequency

13.

Recycling symbol

6.

Protection class

14.

CE labeling

7.

Manufacturer

15.

Media connection

8.

Fuse

16.

Approval marking

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1.

005955

WASHER DISINFECTOR

13

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1 INTRODUCTION

1.8 References Documentation

Contents

User manual

Instructions for daily usage.

x

x

Installation manual

Instructions for assembly, installation and commissioning.

x

x

Quick guide

Instructions for frequently performed tasks.

x

x

Declaration of Conformity

Collection of ISO certificates.

x

-

Electrical diagrams

Collection of circuit diagrams.

-

x

Installation drawing

Installation measurements.

x

x

P&I diagrams

Collection of P&I diagrams.

x

x

Service manual

Instructions for service and preventive maintenance.

-

-

Spare parts

List of available spare parts.

-

-

Program sheets

Description of available programs.

-

x

Loading equipment for Getinge 86-series, 88 Turbo & CM320 washer-disinfectors.

Description of applicable loading equipment.

-

-

Smart loading trolley fixed height User manual for fixed height loading 2.0 for washer-disinfectors. trolley (FHT Disinfection).

-

-

User manual Getinge loading equipment.

-

-

-

-

Instructions for daily use of Getinge loading equipment.

Loading guidebook for common Description of how to load soiled hospital instruments in a Getinge surgical instruments for best possible washer-disinfector. cleaning results.

Paper

Electronic media

x = Delivered with the machine. All documents are available at Getinge Extranet.

This washer-disinfector has an estimated service life of 10 years (40 000 cycles), provided that the recommended maintenance and service stated in the manuals have been carried out according to the instructions.

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1.9 Service life

2 SAFETY

2 SAFETY This section highlights important safety aspects that increases safety awareness. The user must follow the instructions and be familiar with the safety functions before using the machine.

2.1 Safety functions 2.1.1 Door pinch protection If anything is detected between the door and the door frame when closing, the built-in door pinch protection activates and the door reopens. The door will not close as long as it is obstructed.

2.1.2 Password protection The password protected programs can only be started by users with extended rights (login required). For more information, see section 3.3.1 Access rights.

2.1.3 Isolator switch The machine must have a lockable isolator switch for the electric power supply (connected before/outside the machine's electrical connection). The isolator switch is installed by the customer and must be placed on a wall close to the machine. In an emergency, the main power can be switched off using the isolator switch.

2.2 Safety statements Hazardous operations and situations are highlighted in the text. Safety statement structure: •

Warning symbol and signal word.

•

What is the risk? (Short description)

•

What causes the risk? (More precise information)

•

How can the risk be avoided?

Example:

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WARNING! Risk of burns The inside surfaces of the chamber and the load may be hot directly after disinfection. - Let the chamber cool down before entering the chamber. - Be careful when handling hot loads. - Wear protective clothing, such as gloves.

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2 SAFETY

2.3 General warnings WARNING! Risk of electric shock and burns There may be remaining voltage behind the cover panels, even when the power is switched off. - Be careful when removing the cover panels. - Installation and service behind the cover panels must only be performed by personnel with documented experience.

WARNING! Risk of burns The inside of the chamber and the load may be hot. - Let the chamber and the load cool down before unloading. - Wear protective gloves.

WARNING! Risk of burns Hot steam may escape from the chamber when the door is opened after a process is stopped or completed. - Pay attention when standing next to the machine.

Symbol

Hazard

Measure

Warning or Caution

Pay attention.

Warning about hot Pay attention when in contact surfaces with the washer-disinfector's surfaces. Warning about Pay attention when close to dangerous voltage live parts. Do not touch electrical equipment or installations.

2.5 Personal protection Working with the machine includes handling heavy loads and contact with hot surfaces and chemicals. Use protective gear, for example, footwear, gloves, clothing, glasses and other equipment according to local regulations. User Manual Getinge 86-series

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2.4 Safety labels on the machine

2 SAFETY

2.6 Accident or incident reporting

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Accidents or incidents must be reported according to local regulations.

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3 DESCRIPTION

3 DESCRIPTION This section gives an overview of the machine and describes machine details and the control system. It contains necessary information for usage and understanding of the operating instructions.

3.1 Configurations Chamber width (mm)

Chamber length (mm)

Chamber height (mm)

Effective chamber volume (L)

Gross chamber volume (L)

S-8666

650

720

667

312

430

S-8668

650

810

667

351

480

S-8668T

650

810

667

351

480

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Model

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3 DESCRIPTION

3.2 Product description The following illustration shows the machine as seen from the soiled side. Depending on the actual machine configuration, certain parts can appear on either the soiled side, the clean side or both.

12

11 10 9 8 7

1

6

2

5 4

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1.

Control panel

7.

2.

USB (option), behind detergent cabinet door

Guides for transport trolley

8.

Barcode scanner (option)

3.

Detergent cabinet

9.

Main power switch

4.

Lower guide for transport trolley

10.

Process stop (option)

5.

Guides for external loading equipment (option)

11.

Door, chamber

12.

Electrical outlet (option)

6.

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004940

3

Outlet for external loading equipment (option)

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3 DESCRIPTION

3.2.1 Control panel

1

1.

Touchscreen

2.

Printer (option)

004941

2

A machine with two doors has one control panel on each side (soiled side and clean side). The control panel layout may vary depending on the options installed on the washer-disinfector. The machine is controlled and monitored from a control panel with a pressure-sensitive touchscreen. For more information, see section 3.3 Control system.

3.2.1.1 Touchscreen

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The machine is controlled by tapping commands on the touchscreen. The touchscreen also displays alerts. There is one touchscreen on each control panel. For more information, see section 3.3 Control system.

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3 DESCRIPTION

3.2.1.2 Printer (option) 1 2

4

004389

3

1.

Indication lamp

3.

Lid

2.

Feed paper button

4.

Paper

After a program, the printer will automatically print reports (log data). In case of machines with double doors, the printer is only installed on one control panel, either on the clean or on the soiled side. The indication lamp shows the status of the printer: •

A steady green light = the printer is working correctly.

•

A flashing green light = there is something wrong with the printer, for example, the paper needs to be refilled or aligned.

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For more information, see section 3.3.7 Printing and 6.9 Maintenance of printer (option).

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3 DESCRIPTION

3.2.2 USB (option)

004947

1

1.

USB

2

USB socket

2.

USB stick

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1.

005268

1

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3 DESCRIPTION

Only use the USB stick delivered by Getinge.

Do not remove the USB stick while data is being saved. When the touchscreen displays a warning that the USB memory is almost full, it is time to transfer the data to another storage device. The USB option is used as a backup for process reports. The USB port is located inside the detergent cabinet. For more information, see section 6.7.1 Open the detergent cabinet door. The activation of the USB function and the USB stick is optional. If activated, the process reports are saved automatically on the USB stick. A flashing light on the USB stick indicates that data is being saved.

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When the touchscreen displays a warning that the USB memory is almost full, it is time to transfer the data to another storage device.

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3 DESCRIPTION

3.2.3 Detergent cabinet

4

1

2

004945

3

1.

Transport hose

2.

Suction lance

3.

Detergent containers

4.

Dosing pumps

The detergent cabinet contains the detergent system that doses and distributes the detergent to the chamber. As standard, two dosing pumps are installed. Two extra dosing pumps are optional. As standard, the system issues a warning if the detergent level is too low in any of the containers. As an option, flow montoring can be installed. This system issues a warning if the detergent flow between the container and the chamber is too low.

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For more information, see section 6.7.1 Open the detergent cabinet door.

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3 DESCRIPTION

3.2.3.1 How detergents are labeled

If a detergent label or dosage tag is missing or if the product name on the label is not the same as the product name on the detergent container, contact service personnel. Using Getinge detergents The detergent label is attached to the suction lance. The label corresponds to the name on the detergent container. The dosage tag is attached to the cable close to the detergent label.

1

Dos 1 004946

2

1.

Detergent label

2.

Dosage tag

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Using non-Getinge detergents Non-Getinge detergents do not have a detergent label. The detergents used are listed with names on the list of detergents. The names on the list correspond to the names on the detergent containers. The dosage tag is attached to the cable close to the detergent label.

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