Steris Amsco 7053Hp Washer Disinfector Istruzioni per l'uso

OPERATOR MANUAL

Three-Level Ophthalmic Rack

with Removable Upper Insert - Long

(2022-04-25) 10095339

i

Introduction Operator Manual 10095339

This manual contains important information on the proper use and

routine maintenance of the Three-level Ophthalmic Rack with

Removable Upper Insert – Long. All personnel involved in the use

and routine maintenance of this equipment must carefully

review and comply with the Safety Precautions and instructions

contained in this manual.

These instructions are important to

protect the health and safety of personnel using the

Three-level

Ophthalmic Rack with Removable Upper Insert – Long to process

items in the AMSCO® 7053L Single-Chamber Washer/Disinfector and

should be retained in a conveniently accessible area for quick

reference.

Advisory IMPORTANT: A listing of the Safety Precautions to be observed

when using and servicing this equipment can be found in SECTION 1

of this manual. Do not use the equipment until you have become

familiar with this information.

STERIS does not intend, recommend or represent in any way that the

Three-level Ophthalmic Rack with Removable Upper Insert – Long

be used in the AMSCO 7053L Single-Chamber Washer/Disinfector

for the terminal disinfection or sterilization of any regulated medical

device.

The

Three-level Ophthalmic Rack with Removable Upper

Insert – Long is intended only to perform an initial step in the

processing of soiled, reusable medical devices in the washer/

disinfector. If medical devices will be contacting blood or

compromised tissues, such devices must be terminally processed

in accordance with Good Hospital Practices before each use in

human patients.

STERIS does not recommend processing flexible endoscopes, single-

use instruments, rigid telescopes (optical lens), fiber-optic cables,

multi-part instruments that cannot be disassembled, heat-sensitive

devices and coagulating electrodes using the Three-level Ophthalmic

Rack with Removable Upper Insert – Long in the washer/disinfector.

Processing these types of instruments may result in instrument or

equipment damage as well as improperly cleaned items. All items

processed using the Three-level Ophthalmic Rack with Removable

Upper Insert – Long in the washer/disinfector must withstand

temperatures of up to 116°C (240°F).

The Three-level Ophthalmic Rack with Removable Upper Insert –

Long

is specifically designed to only hold items as outlined in this

manual. If there is any doubt about a specific material or product,

contact the instrument manufacturer for recommended washing

techniques.

A WORD FROM STERIS

ii

10095339 Operator Manual Introduction

Any alteration of this equipment not authorized or performed by

STERIS will void the warranty. Alteration of this equipment which

could adversely affect its operation and efficacy may violate national,

state and local laws or regulations.

Serious incidents that have occurred in relation to this medical

device should be reported to the manufacturer and competent

authority in the country where the incident occurred.

Indications For Use The Three-level Ophthalmic Rack with Removable Upper Insert –

Long is designed to be used in the AMSCO 7053L Single-Chamber

Washer/Disinfector for the efficient cleaning, rinsing, drying and

intermediate level disinfection of different types of ophthalmic

instruments that, according to device manufacturer’s instructions for

use, can be processed in a washer/disinfector.

IMPORTANT: The Three-level Ophthalmic Rack with Removable

Upper Insert – Long is designed to be used only with the Rigid MIS

cycle.

Service Information A thorough preventive maintenance program is essential to help

ensure safe and proper washer/disinfector and rack operation. This

manual contains a routine maintenance procedure which should be

followed for satisfactory equipment performance.

Customers are encouraged to contact STERIS concerning extended

service maintenance agreements to give your washer/disinfector

and rack planned maintenance, which will help ensure equipment

performance according to factory specifications. STERIS maintains a

global staff of well-equipped, qualified service technicians to provide

this service, as well as professional repair services. Please contact

STERIS for details.

iii

Introduction Operator Manual 10095339

Technical

Specifications

Three-level Ophthalmic Rack with Removable Upper Insert –

Long:

• Overall size: 648 x 825 x 561 mm

• Weight: 26 kg

• Material: Stainless steel, Plastic, Silicone, Polypropylene

Total load capacity:

• 4 vitrectomy ophthalmic instrument sets

• 4 cataract ophthalmic instrument sets

• 2 spare slots for DIN trays

Load capacity for cannulated instruments:

• 4 bimanual irrigation handpieces holder

• 4 bimanual aspiration handpieces holder

• 4 phako instrument holder

• 4 micro tweezers instruments holder

• 16 hollow jets Ø 4x60 mm for cannulated instruments

• 4 hollow jets Ø 4x59 mm for cannulated instruments

• 8 hollow jets Ø 4x50 mm for cannulated instruments

• 20 Luer locks male, 4 Luer locks female for cannulated

instruments

• 4 phako tip holder

• 4 quick tip I/A holder

• 7 bulldog instruments holder

• 8 holders for biom lens

Certification The AMSCO 7053L Single-Chamber Washer/Disinfector, compatible

with the Three-Level Ophthalmic Rack with Removable Upper Insert -

Long, meet the applicable requirements of certain standards. Refer

to washer/disinfector Operator Manual (10085881) for the current list

of standards.

iv

10095339 Operator Manual Introduction

The base language of this

document is ENGLISH. Any

translation must be made from

the base language document.

Manufactured by:

STERIS Canada ULC

490 boulevard Armand-Paris

Québec (Québec)

Canada G1C 8A3

European Community Representative:

STERIS Ireland Limited

IDA Business and Technology Park

Tullamore

County Offaly

R35 X865

Ireland

Sales and Service -- Europe, Middle-East and Africa:

STERIS

116 Avenue de Magudas, 33185

Le Haillan

FRANCE

Support Service, by email:

Support_EMEA_IPT_SE@steris.com

All other requests, by phone: +33 5 56 93 94 94

Website:

www.steris.com

Sales and Service -- Americas, Oceania and Asia:

STERIS Corporation

5960 Heisley Road

Mentor, Ohio 44060

800-548-4873

TABLE OF CONTENTS

Section

Number Description Page

v

Table of Contents Operator Manual 10095339

A WORD FROM STERIS .......................................................................................... I

Advisory ........................................................................................................................................................... i

Indications For Use ..........................................................................................................................................ii

Service Information ..........................................................................................................................................ii

Technical Specifications .................................................................................................................................iii

Certification......................................................................................................................................................iii

1 SAFETY PRECAUTIONS .....................................................................................1-1

2 LOADING INSTRUCTIONS ..................................................................................2-1

2.1 Three-level Ophthalmic Rack with Removable Upper Insert – Long: Components ............................. 2-1

2.2 Three-level Ophthalmic Rack with Removable Upper Insert – Long: Sections .................................... 2-2

2.3 Preparing Instruments ........................................................................................................................... 2-6

2.4 Loading Rack ........................................................................................................................................ 2-6

2.5 Ophthalmic Insert .................................................................................................................................. 2-8

3 OPERATING INSTRUCTIONS .............................................................................3-1

4 UNLOADING INSTRUCTIONS .............................................................................4-1

4.1 Unloading Three-Level Ophthalmic Rack with Removable Upper Insert– Long................................... 4-1

4.2 Visual Inspection ................................................................................................................................... 4-2

5 ROUTINE MAINTENANCE AND REPLACEMENT PARTS ....................................5-1

5.1 Routine Maintenance ............................................................................................................................ 5-1

5.2 Replacement Parts ................................................................................................................................ 5-2

vi

10095339 Operator Manual Table of Contents

2 LOADING INSTRUCTIONS ..................................................................................2-1

2-1 Three-Level Ophthalmic Rack with Removable Upper Insert– Long – Components ........................ 2-1

2-2 Ophthalmic Upper Insert ................................................................................................................... 2-2

2-3 Base Rack ......................................................................................................................................... 2-3

2-4 Assembling Ophthalmic Rack ........................................................................................................... 2-4

2-5 Ophthalmic Basket Pre-Loaded ........................................................................................................ 2-5

2-6 Loading Lower Part (Base Rack) ....................................................................................................... 2-6

2-7 Virectomy Ophthalmic Instrument Set ............................................................................................... 2-7

2-8 Load Instruments on Instrument Holder ............................................................................................ 2-8

2-9 Loading Instruments and Tips on Luer Locks (1 of 2) ....................................................................... 2-9

2-10 Loading Instruments and Tips on Luer Locks (2 of 2) ..................................................................... 2-10

2-11 Loading Cannulated Instruments .................................................................................................... 2-11

2-12 Instrument Holder ............................................................................................................................ 2-11

2-13 Loading Lenses ............................................................................................................................... 2-12

2-14 Loading Instruments on Hollow Jets ............................................................................................... 2-12

2-15 Mounting Protective Cover .............................................................................................................. 2-13

2-16 Loading Micro Tweezers on Protective Cover .................................................................................2-13

2-17 Connecting Tubes ........................................................................................................................... 2-14

2-18 Loaded Three-Level Ophthalmic Rack with Removable Upper Insert– Long.................................. 2-14

5 ROUTINE MAINTENANCE AND REPLACEMENT PARTS ....................................5-1

5.1 Replacement Parts ................................................................................................................................ 5-2

LIST OF ILLUSTRATIONS

Figure

Number Description Page

LIST OF TABLES

Table

Number Description Page

1-1

Safety Precautions Operator Manual 10095339

1

The following Safety Precautions must be observed when operating or servicing the Three-Level Ophthalmic

Rack. 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 equipment.

Strictly following these Safety Precautions enhances the Customer’s ability to safely and effectively utilize the unit

and helps avoid improper maintenance methods which may damage the unit or render it unsafe. It is important to

understand that these Safety Precautions are not exhaustive; Customers are encouraged to develop their own

safety policies and procedures to enhance and complement these Safety Precautions.

WARNING – PERSONAL INJURY AND/OR EQUIPMENT DAMAGE HAZARD:

WARNING – BURN HAZARD:

Always wear Personal Protective Equipment (PPE) appropriate to the task to perform.

Always load or unload the Three-level Ophthalmic Rack with Removable Upper Insert – Long on

appropriate loading cart or surface.

Always load and unload the Three-level Ophthalmic Rack with Removable Upper Insert – Long facing

rack. Trocar ends sticking out of the rack can be extremely sharp and can cause injuries such as cuts.

Incorrect rack loading or overloading could lead to injury and/or damage to the equipment or

instruments.

Regularly scheduled preventive maintenance is required for safe and reliable operation of this

equipment. Contact STERIS to schedule preventive maintenance or obtain the necessary washer/

disinfector Maintenance Manual if preventive maintenance is done by the Customer.

Repairs and adjustments to this equipment must be made only by STERIS or STERIS-trained service

personnel. Repairs and adjustments performed by unqualified personnel or installation of unauthorized

parts could cause personal injury, result in improper equipment performance, void the warranty or result

in costly damage. Contact STERIS regarding service options.

Three-level Ophthalmic Rack with Removable Upper Insert – Long and items are extremely hot when

cycle is completed. Allow rack and items to cool to room temperature and always wear appropriate

Personal Protective Equipment (PPE) before reaching into chamber.

When cycle is completed, wait until water flow stops before opening door and unloading washer/

disinfector. Hot water or steam may be sprayed through door opening if door is opened too soon. Wear

appropriate Personal Protective Equipment (PPE) whenever reaching into chamber.

SAFETY PRECAUTIONS

1-2

10095339 Operator Manual Safety Precautions

CAUTION – POSSIBLE EQUIPMENT DAMAGE:

To avoid equipment damage and maximize processing efficiency, always load soiled items as instructed

in this Three-level Ophthalmic Rack with Removable Upper Insert – Long Operator Manual.

To prevent voiding the warranty or damaging the equipment, use only authorized STERIS replacement

parts.

Use nonabrasive cleaners when cleaning the Three-level Ophthalmic Rack with Removable Upper

Insert – Long. Follow directions on containers and rub in a back-and forth motion (in same direction as

surface grain). Abrasive cleaners will damage stainless steel.

2

2-1

Loading Instructions Operator Manual 10095339

2.1 Three-level

Ophthalmic Rack with

Removable Upper

Insert – Long:

Components

See Figure 2-1.

Before using the Three-level Ophthalmic Rack with Removable

Upper Insert – Long, it is important to become familiar with the

location of the rack components.

IMPORTANT: A listing of the Safety Precautions to be observed when using and servicing this equipment

can be found in SECTION 1 of this manual. Do not use the equipment until you have become familiar with

this information.

Figure 2-1. Three-level Ophthalmic Rack with Removable Upper Insert – Long: Components

Rack Base

Ophthalmic Insert

(Upper Level)

Spray Arms

Bar code tag location.

Use bar code Gentle (06)

LOADING INSTRUCTIONS

2-2

10095339 Operator Manual Loading Instructions

2.2 Three-level

Ophthalmic Rack with

Removable Upper

Insert – Long: Sections

The rack has three levels; two on the base rack and one level for the

ophthalmic insert.

The ophthalmic insert is designed to hold cannulated ophthalmic

instruments and suction tubes using rack components (instrument

holders, Luer locks, hollow jets, etc.) and has space for four

ophthalmic baskets.

4'(ÄÄ

Hollow Jets

(Two Rows)

Bimanual

Aspiration Hand

Pieces Holder

Slots for Lens Holder

Quick Tip I/A

Holder

Protective Cover for

Micro Tweezers Holder

Luer Locks

Phako Instrument

Holders

Phako Tip

Holder

Space for Ophthalmic

Baskets

Figure 2-2. Ophthalmic Upper Insert

Ophthalmic Basket

2-3

Loading Instructions Operator Manual 10095339

The lower section of the rack is divided in two levels and is

equipped with two rotary spray arm assemblies and Cool Touch

Handles.

Lower section has space for six ophthalmic baskets.

Figure 2-3. Base Rack

Spray Arms

Cool Touch

Handles (4 x)

2-4

10095339 Operator Manual Loading Instructions

Place the Ophthalmic insert into the base rack as shown:

Figure 2-4. Assembling Ophthalmic Rack

2-5

Loading Instructions Operator Manual 10095339

2.3 Preparing

Instruments

To prepare instruments for processing, proceed as follows:

• Disassemble all instrument components prior to loading them in

the Three-level Ophthalmic Rack with Removable Upper Insert –

Long and ophthalmic baskets.

• Fully open all handles, jaws and graspers.

• Manually clean any visible soil on cannulated instruments. Follow

device manufacturer’s instructions for use to manually clean

instruments.

• Pre-load ophthalmic baskets with the appropriate instruments.

• Load a cataract ophthalmic instrument set in an ophthalmic

basket. Place basket on ophthalmic rack lower levels.

• Load a vitrectomy ophthalmic instrument set in an ophthalmic

basket Place basket on the upper level on ophthalmic insert.

• Cannulated ophthalmic instruments and suction tubes are

loaded onto special instrument holders on the ophthalmic insert.

2.4 Loading Rack • Lower Part (Base Rack)

To load the base rack, proceed as follows:

1. Mount ophthalmic insert onto base rack.

2. Pre-load ophthalmic baskets with appropriate instruments.

Cataract ophthalmic instrument set is loaded on base rack.

IMPORTANT: Baskets should not be overloaded with

instruments to ensure cleaning efficacy.

WARNING – PERSONAL INJURY

AND/OR EQUIPMENT DAMAGE

HAZARD: Always load or unload

the Three-level Ophthalmic Rack

with Removable Upper Insert –

Long on appropriate loading cart

or surface.

Figure 2-5. Ophthalmic Basket Pre-Loaded

2-6

10095339 Operator Manual Loading Instructions

3. Slide ophthalmic baskets into base rack from the side.

4. Put three cataract ophthalmic instrument sets on each level of

base rack.

5. Ensure baskets do not project out of the rack so when the rack is

pushed into the washer, the basket does not hit the door

enclosure.

6. Once the basket is loaded, ensure that instruments are not

interfering with the spray arm rotation.

CAUTION – POSSIBLE EQUIPMENT

DAMAGE: To avoid equipment

damage and maximize processing

efficiency, always load soiled

items as instructed in this Three-

level Ophthalmic Rack with

Removable Upper Insert – Long

Operator Manual.

Figure 2-6. Loading Lower Part (Base Rack)

2-7

Loading Instructions Operator Manual 10095339

2.5 Ophthalmic Insert The upper section of the ophthalmic rack is designed to hold

cannulated ophthalmic instruments and suction tubes using rack

components (instrument holders, Luer locks, hollow jets, etc.).

Furthermore, it can also accommodate four ophthalmic baskets to

process non-cannulated ophthalmic instruments.

The ophthalmic insert may hold the following items:

• 4 bimanual irrigation handpieces holder

• 4 bimanual aspiration handpieces holder

• 4 phako instrument holder

• 4 micro tweezers instruments holder

• 16 hollow jets Ø 4x60 mm for cannulated instruments

• 4 hollow jets Ø 4x59 mm for cannulated instruments

• 8 hollow jets Ø 4x50 mm for cannulated instruments

• 20 luer-locks male, 4 Luer locks female for cannulated

instruments

• 4 phako tip holder

• 4 quick tip I/A holder

• 7 bulldog instruments holder

• 8 holders for biom lens

To load the ophthalmic insert, proceed as follows.

1. Prepare empty Ophthalmic insert. Mount Ophthalmic insert onto

base rack (if not already done).

2. Pre-load ophthalmic baskets with appropriate instruments;

vitrectomy ophthalmic instrument set is loaded on ophthalmic

insert.

WARNING – PERSONAL INJURY

AND/OR EQUIPMENT DAMAGE

HAZARD: Always load or unload

Three-level Ophthalmic Rack

with Removable Upper Insert –

Long on appropriate loading cart

or surface.

Figure 2-7. Virectomy Ophthalmic Instrument Set

2-8

10095339 Operator Manual Loading Instructions

3. Mount instruments onto special instrument holder on ophthalmic

insert.

- There is space for four sets.

- Every set has two cannulated instruments which are connected

with two tubes each.

- Caps are mounted on the hollow jets.

CAUTION – POSSIBLE EQUIPMENT

DAMAGE: To avoid equipment

damage and maximize processing

efficiency, always load soiled

items as instructed in this Three-

level Ophthalmic Rack with

Removable Upper Insert – Long

Operator Manual.

Figure 2-8. Load Instruments on Instrument Holder

Caps Mounted on Hollow Jets

2-9

Loading Instructions Operator Manual 10095339

Figure 2-9. Loading Instruments and Tips on Luer Locks (1 of 2)

2-10

10095339 Operator Manual Loading Instructions

Tip

Figure 2-10. Loading Instruments and Tips on Luer Locks (2 of 2)

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