arcus Instructions for Use Release 1.0 Oct 2009

© Schaerer Medical AG Erlenauweg 17 CH-3110 Münsingen Tel.: +41 (0) 31 720 22 00 Fax: +41 (0) 31 720 22 30 E-Mail: [email protected] Internet: www.schaerermedical.ch Release: 1.0 Updated by: MK

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Date: 15.10.2009

Operating table schaerer® arcus

Table of contents

1

2

3

4

General Provision ...6 1.1

Information about these Instructions for use ...6

1.2

Explanation of symbols ...7

1.3

Limit of liability...8

1.4

Subject to technical changes ...8

1.5

Copyright...8

1.6

Spare parts and accessories ...9

1.7

Warranty terms ...9

1.8

Customer service ...9

1.9

CE label ...10

Safety ...11 2.1

Responsibility of the operator ...11

2.2

Personnel requirements...13

2.3

Intended use ...15

2.4

Personal protective equipment ...16

2.5

Special hazards ...17

2.6

Behaviour in a hazardous situation ...19

2.7

Environmental protection ...20

2.8

Labelling...21

Technical Data...22 3.1

Dimensions and weights...22

3.2

Terms of use ...28

3.3

Classification...28

3.4

Accumulators ...29

3.5

Type plate ...29

Structure and function ...30 4.1

Main components ...30 4.1.1

Base components...30

4.1.2

Components back plate...31

4.1.3

Special features of Schaerer Arcus 500/501...31

4.1.4

Special features of Schaerer Arcus 700/701...32

4.2

Basic positions/ patient positioning...33

4.3

Brief description ...34 4.3.1

General information...34

4.3.2

Schaerer Arcus 500/501...35

4.3.3

Schaerer Arcus 600/601...36

4.3.4

Schaerer Arcus 700/701...37

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Operating table schaerer® arcus

Table of contents

5

4.4

Controls ...38

4.5

Emergency control ...39

4.6

Manual control unit...40

4.7

Operation modes...41

4.8

Hazard areas...41

Transport, packaging, storage...43 5.1

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Transport...43 5.1.1

Safety instructions for the transport...43

5.1.2

Transport inspection ...44

5.2

Packing ...45

5.3

Shipping conditions ...47

5.4

Storage...48

Installation and initial use ...49 6.1

Safety ...49

6.2

Installation site ...49

Use ...50 7.1

Safety ...50

7.2

Modes ...51 7.2.1

Normal operating mode with accumulators ..51

7.2.2

Emergency operation with accumulators ...52

7.2.3

Emergency operating mode with main power supply...53

7.3

Charge accumulators ...54

7.4

Monitor system condition ...57

7.5

Steps before use ...59 7.5.1

Disinfection and cleaning...59

7.5.2

Attaching table top accessorys...59

7.5.3

Set patient positioning ...61

7.5.4

Set mode for patient weight over 260 kg (only applies for versions Arcus 501, 601 and 701)...62

7.5.5

Attach accessories to side rails ...63

7.5.6

Putting the operating table in a locked position ...64

7.5.7

Locking of the operating table ...66

7.5.8

Functional test ...67

7.6

Turn on operating table ...68

7.7

Turn off operating table ...68

7.8

Cut-off in case of emergency ...68

7.9

Move operating table...69 7.9.1

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Security...69

Operating table schaerer® arcus

Table of contents 7.9.2

Transport patients ...71

7.9.3

Operation in conjunction with highfrequency surgery...72

7.9.4

Operating table with emergency control unit...73

7.9.5

Set speed of movements...73

7.9.6

Height adjustment of the table top accessorys...74

7.9.7

Tilting function ...75

7.9.8

Trendelenburg settings...76

7.9.9

Set Flex and Reflex position...76

7.9.10

Set Level-Position ...77

7.10 Steps after use...77 8

9

Maintenance ...78 8.1

Safety...78

8.2

Maintenance plan ...79

8.3

Cleaning and disinfection...81 Safety ...81

8.3.2

Cleaning ...82

8.3.3

Disinfection ...83

Troubleshooting...84 9.1

Safety...84

9.2

Error tables ...85

9.3 10

8.3.1

9.2.1

Malfunction table accumulators...85

9.2.2

Malfunction table hydraulics ...85

9.2.3

Malfunction table manual control...88

9.2.4

Malfunction table emergency operation ...88

9.2.5

Malfunction table foot switch ...89

9.2.6

Malfunction table electronics ...89

9.2.7

Malfunction table patient positioning ...90

9.2.8

Malfunction table master-pump error ...91

Error-Codes/Error Messages (SW error key) ...92

Dismantle ...94 10.1 Safety...94 10.2 Decommissioning ...95 10.3 Disposal ...95

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Appendix...97 Declaration of Corformity ...97

12

Index ...99

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Operating table schaerer® arcus

General Provision

1 General Provision 1.1 Information about these Instructions for use These instructions for use allow the safe and efficient handling of the device. The manual is part of the device and must be kept in immediate proximity to the device so that it is accessible for the staff at any time. The personnel must have carefully read and understood these instructions before starting any work. Basic requirement for safe operation is the compliance with all safety notices and handling instructions stated in this manual. In addition, the local accident prevention regulations and general safety rules apply for the area of application of the device. Illustrations in this user manual only serve the purpose of providing a conceptual understanding and may differ from the actual design of the device.

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Operating table schaerer® arcus

General Provision 1.2 Explanation of symbols Safety instructions

This manual uses symbols to identify safety instructions. The safety instructions are preceded by signal words that indicate the severity of the risk. Safety instructions must be referd to under any circumstances. Act with caution to avoid accidents, personal injury and material damage.

DANGER! … alerts to an immediate hazardous situation which may lead to death or serious injuries, if it is not avoided.

WARNING! … alerts to a potentially hazardous situation which may lead to death or serious injuries if it is not avoided.

ATTENTION! … indicates a possibly dangerous situation that could cause minor injuries if it is not avoided.

CAUTION! … indicates a possibly dangerous situation that could cause material damage if it is not avoided.

Tips and recommendations

NOTE! ... emphasizes useful tips and recommendations as well as information for efficient and trouble-free operation.

Special safety notes

The following symbols are used in safety instructions to make you aware of particular hazards: ... indicates hazards due to electric shock. Non-compliance with the safety instructions presents the danger of severe or fatal injuries.

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Operating table schaerer® arcus

General Provision 1.3 Limit of liability All information and notes in this user manual have been compiled in compliance with the applicable standards and regulations, the current state of technology as well as our extensive years of research and experience. The manufacturer does not assume any liability for damage caused by:
Non-refernce to the manual
Non-intended use
Deployment of untrained staff
Unauthorized retooling
Technical changes

Use of unapproved spare parts

Use of unapproved accessories

In conjunction with special orders, the usage of additional order options or due to newest technological changes, the actual scope of delivery may deviate from the explanations and illustrations described in this manual. The obligations agreed to in the delivery contract, the general terms and conditions as well as the delivery conditions of the manufacturer shall apply in addition to the respective legal regulations that are applicable at the time the contract becomes effective.

1.4 Subject to technical changes We reserve the right to make technical changes in the course of improving the performance characteristics and further enhancement.

1.5 Copyright This manual is subject to copyright law and is exclusively intended for internal purposes. Surrendering the instruction manual to third parties, reproduction in any way or form - including in extracts - as well as an exploitation and/or conveyance of the content without written authorization of the manufacturer is not permitted, except the use for internal purposes. Violations are subject to compensation for damages. Additional claims shall be reserved.

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Operating table schaerer® arcus

General Provision 1.6 Spare parts and accessories WARNING! Safety risk due to wrong spare parts and accessories! Wrong or defective spare parts and accessories can compromise the safety and cause damage, malfunction or total failure. Therefore: – Only use the manufacturer's original spare parts and accessories.

Order spare parts and accessories from authorized dealers or directly from the manufacturer. In case of questions, contact the dealer or manufacturer. The address is listed on page 2.

WARNING! Safety risk due to protruding attachments! In case of protruding attachments, improper use can present a risk of injury to the patient and the personnel - e.g. due to tilting of the OP table. Therefore: – Always read and follow the instructions in the instruction manual for the accessories.

1.7 Warranty terms The warranty terms are included in the General Terms and Conditions of the manufacturer.

1.8 Customer service Our customer service is available to provide technical information. The contact information is listed on page 2. In addition, our employees are always interested in new information and experiences that arise from the use of the device and that could be valuable for improving our products.

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Operating table schaerer® arcus

General Provision 1.9 CE label The device fulfils the requirements of the EC guidelines for medical products. The label with the CE mark is located on the type plate (see section "Type plate"). The declaration of conformity can be found in the Appendix (section #11).

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Operating table schaerer® arcus

Safety

2 Safety This section offers an overview of all important safety aspects to provide optimal protection of the staff and to ensure safe and uninterrupted operation. Non-compliance with the operating instructions and safety regulations listed in this user manual may lead to extremely hazardous situations.

2.1 Responsibility of the operator The device is used in a commercial environment. The operator of the device is therefore subject to the obligations as stipulated by the Occupational Health and Safety Act. In addition to the safety notices in this user manual, the safety, accident prevention and environmental regulations that apply to the area of application of the device must be referd to. In this context, the following shall apply in particular:
The operator must familiarize himself with the applicable occupational safety regulations and also conduct a risk assessment to determine additional risks that may arise due to the specific working conditions at the place of use of the device. He must implement these in the form of user manuals for working with the device.
During the entire time of use, the operator must check whether the user instructions that were established by the operator correspond with the respective current applicable rules and standards and the operator must adjust the operating instructions if necessary.

The operator must clearly regulate and specify responsibilities for installation, operation, maintenance, and cleaning.

The operator must ensure that all hygiene provisions for rooms used for medical purposes and the use of medical equipment are referd to.

The operator must ensure that all employees who handle the device have read and understood these instructions. In addition, he must train the personnel at regular intervals and inform them about the hazards.
The operator must provide the personnel with the required protective gear.

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Operating table schaerer® arcus

Safety Furthermore, the operator is responsible for making sure that the device is always in perfect technical condition. Therefore, the following applies:
The operator must ensure that the maintenance intervals described in this user manual are referd to.
The operator must have all safety systems checked regularly for functionality and completeness.

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Operating table schaerer® arcus

Safety 2.2 Personnel requirements Insufficient qualification

WARNING! Risk of injury in case of insufficient qualification! Improper handling of the device can cause severe personal injury and property damage. Therefore: – All work may only be carried out by respectively qualified staff.

Qualification

The following qualifications for different areas of responsibility are listed in the user manual:
Medical specialist is in a position, due to his or her professional medical training, knowledge, and experience, to perform the work assigned to him or her safely. Medical specialists can detect, assess, and avoid possible hazards to themselves or the patients on their own. Medical specialists are familiar with the content of all valid regulations, guidelines, and standards that are required by lawmakers for the safe use of the device, and they can implement the requirements set out therein. Medical specialists have the necessary professional knowledge in the area of application for the device and refer to all hygiene provisions for rooms used for medical purposes and the use of medical products.
A trained person has been trained in a training session by the operator for the work he or she is tasked to perform and possible risks in conjunction with improper behaviour. The training will be documented in writing.
Specialized personnel are in a position, due to their specialized professional training, knowledge and experience as well as knowledge of the industry specific regulations, to perform assigned tasks and to identified and avert potential risks on their own.

Immunization

Any personnel working with the device must have received the local and hospital-specific immunizations to protect against infection.

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Operating table schaerer® arcus

Safety Unauthorized persons

WARNING! Hazard for unauthorized persons! Unauthorized persons who do not fulfil the requirements described herein do not know the dangers in the work area. Therefore: – Keep unauthorized persons away from work area. – In a questionable situation, address persons and tell them to leave the work area. – Discontinue the work as long as unauthorized persons are present in the work area.

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Operating table schaerer® arcus

Safety 2.3 Intended use This device has been designed and built exclusively for the intended use described here.
The device is to be used only for applications in human medicine.
The device serves to hold and position a patient during an examination or immediately before, during or after a surgical intervention.
The device may be used exclusively in rooms used for medical purposes.
Patients may be transported with the device only within an OR area and only over short distances.
Any additional uses must be confirmed with the manufacturer and documented in writing.

Proper use also includes refernce to all details in this instruction manual as well as the refernce to all inspection and maintenance terms. Any utilization of the device that exceeds or deviates from the intended use is deemed a misuse and may lead to hazardous situations. WARNING! Risk from misuse! Misuse of the device can lead to hazardous situations. Do not use the device for the following purposes in particular: –

Use of the device as a means of transport for objects and loads.

–

Use of the device as a lift truck and work platform.

–

Use of the device outside of an operating room.

Any claims in conjunction with damage caused by non-intended use will be void.

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Operating table schaerer® arcus

Safety 2.4 Personal protective equipment Over and above the normal medical protective equipment, the wearing of personnel protective equipment is required for particular work to minimize health hazards.
The protective equipment that is required for the respective work has to be worn during that work at all times.
Refer to the notices concerning personal protective equipment that are posted in the work area. Special reference will be made to special protective equipment in the individual sections of this instruction manual. This special protective equipment will be explained below: Protective gloves for the protection of the hands against rubbing, abrasions, punctures or deeper wounds, as well as for the prevention of infections. Safety glasses for the protection of the eyes against flying parts and sprays of liquid as well as for the prevention of infections.

Hygienic respiratory protection for the protection against infection due to bacteria in the ambient air and in sprays of liquid.

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Operating table schaerer® arcus

Safety 2.5 Special hazards The following section lists remaining hazards that have been identified as a result of a risk assessment.
Refer to the safety instructions listed here and the warnings in the subsequent chapters of this user manual to reduce health hazards and to avert dangerous situations. Electricity

RISK! Risk of fatal injury due to electric power! The use of the operating table in areas subject to explosions presents a risk of explosion and incorrect handling of the power supply presents a risk of explosion. There is an immediate risk of fatal injury. Therefore:

Mechanical forces

–

Use operating table exclusively in rooms suited for medical use.

–

Exactly refer to process steps for the charging of the accumulators.

–

Only use operating table during the failure of the internal power supply on the main power system.

WARNING! Risk of fatal injury through mechanical forces! The use of the operating table on uneven surfaces and the moving of a patient to another bed while the operating table is not in a locked position presents the risk that the operating table tilts over or rolls away. There is a risk of fatal injury for the patient by falling off the operating table. Therefore: –

Only use the operating table on even surfaces.

–

Only move patients to other beds when the operating table is in locked position.

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Operating table schaerer® arcus

Safety Suspended weights

WARNING! Risk of injury due to suspended weights! Insufficiently latched table top accessorys can fall off during the use of the operating table. There is a risk of injury for the patient. Therefore:

Movable components

–

Ensure prior to the use of the operating table that all table top area accessorys are properly latched.

–

Exactly refer to the processing steps for attaching the table top accessorys.

WARNING! Risk of injury through movable components! Movable components present a risk of injury for personnel and patients through crushing and pinching of body parts and sliding off of the operating table. Therefore:

Hygiene

–

Do not reach under the table top while using operating table.

–

Secure patient on the operating table in accordance with the anticipated operation.

–

Only move the operating table while constantly monitoring the patient.

WARNING! Risk of infection and injury through insufficient hygiene! Insufficient hygiene increases the risk of infection and injuries for personnel and patients. Therefore: – Refer to all applicable local requirements for hygiene, cleaning and surface area disinfection.

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Operating table schaerer® arcus

Safety 2.6 Behaviour in a hazardous situation

At the judgement of the operator: 

Rescue the patient and stop the operation.



Move the patient to another bed.



Continue the operation.

In a hazardous situation, take the operating table out of commission immediately.

Have the manufacturer or customer service rectify errors.

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Operating table schaerer® arcus

Safety 2.7 Environmental protection CAUTION! Environmental hazard due to incorrect handling! Incorrect handling of environmentally hazardous materials, especially as it relates to incorrect disposal, may lead to significant environmental damage. Therefore: – Always follow the notices listed below. –

Immediately take suitable action if environmentally-hazardous materials have unintentionally been released to the environment.

–

In case of doubt, inform the responsible local authority regarding the damage.

The following environmentally-hazardous materials are used: Rechargeable batteries

Rechargeable batteries contain toxic heavy metals. They are subject to special waste disposal handling and must be taken to community collection sites or disposed of by a professional disposal company.

Hydraulic oil

Hydraulic oil contains toxic substances. It must not be released to the environment. The disposal must be handled by a specialized professional disposal company.

Cleaning and disinfection agents

Cleaning and disinfection agents contain chlorine and solvents. They are subject to special waste disposal handling and must be taken to community collection sites or disposed of by a professional disposal company.

Electronic and electrical components

Take electronic and electrical components to the community collection sites or a professional company for disposal.

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