OPERATING INSTRUCTIONS MEDAP EQUIPMENT …cdn.atmosmed.com/docs/16275/ga57520024gb16...OPERATING...

OPERATING INSTRUCTIONSMEDAPEQUIPMENT RAILS

GA 5752.0024 GB 16

GA 5752.0024 GB 162

Subject to technical modification!Illustrations and technical specifications may vary slightly from those in these Operating Instructions as a result of ongoing product development.

V16 2017-08

GA 5752.0024 GB 16 3

Table of contents

Table of contents

1 Introduction ..............................................................................................................................................51.1 How to use these operating instructions ....................................................................................................5

1.1.1 General ........................................................................................................................................51.1.2 Symbols .......................................................................................................................................5

1.1.2.1 Actions and responses .............................................................................................. 51.1.3 Definitions ....................................................................................................................................5

1.1.3.1 Design of safety notes ............................................................................................... 51.1.3.2 Design for other notes ............................................................................................... 6

1.1.4 Symbols used ..............................................................................................................................61.2 Disposal ......................................................................................................................................................7

1.2.1 General ........................................................................................................................................71.2.2 Packing ........................................................................................................................................71.2.3 ATMOS products ..........................................................................................................................7

1.3 EQUIPMENT RAILS ...................................................................................................................................81.3.1 Overview of equipment rail .......................................................................................................... 81.3.2 Use in accordance with the intended purpose .............................................................................81.3.3 Applicable standards .................................................................................................................... 81.3.4 Intended purpose .........................................................................................................................91.3.5 Versions .....................................................................................................................................10

1.3.5.1 Equipment rails with fixed lengths ........................................................................... 101.3.5.2 Equipment rail with variable lengths ........................................................................ 10

2 Safety notes ............................................................................................................................................ 11

3 Mounting .................................................................................................................................................123.1 Scope of delivery ......................................................................................................................................123.2 Equipment rail ..........................................................................................................................................123.3 Potential equalisation ...............................................................................................................................13

3.3.1 Turning the clamping collar (optional) ........................................................................................143.4 Cover caps ...............................................................................................................................................143.5 Mechanical connection .............................................................................................................................153.6 Acceptance report ....................................................................................................................................15

4 Cleaning and disinfection ......................................................................................................................164.1 Safety notes .............................................................................................................................................164.2 Cleaning of equipment components .........................................................................................................164.3 Disinfection ...............................................................................................................................................16

5 Maintenance ............................................................................................................................................185.1 General .....................................................................................................................................................185.2 Repairs .....................................................................................................................................................185.3 Service hotline: .........................................................................................................................................18

GA 5752.0024 GB 164

Table of contents

5.4 Sending in the device ...............................................................................................................................18

6 Technical specifications ........................................................................................................................196.1 General .....................................................................................................................................................196.2 Ambient conditions ...................................................................................................................................19

7 Accessories and spare parts ................................................................................................................207.1 Accessories ..............................................................................................................................................207.2 Spare parts ...............................................................................................................................................20

8 Acceptance report ..................................................................................................................................218.1 The following tests were performed .........................................................................................................21

IntroductionHow to use these operating instructions

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1 Introduction

1.1 How to use these operating instructions

1.1.1 GeneralThese operating instructions are provided to familiarise you with the features of this ATMOS product. They are subdivided into several chapters.

Please note:• Please read these operating instructions carefully and completely before using the product for

the first time.• Always proceed in accordance with the information contained herein.• Store these operating instructions in a location near the product.

1.1.2 Symbols

1.1.2.1 Actions and responsesThe „“ symbol identifies an action taken by the user while the „“ symbol identifies the reaction that this will induce in the system.

Example: Turn on the light switch.

Lamp lights up.

1.1.3 Definitions

1.1.3.1 Design of safety notes

Pictogram Descriptor Text

DANGER!Indicates a direct and immediate risk to persons, which may be fatal or result in most serious injury.

The text for the safety note describes the type of risk and how to avert it.

WARNING!Indicates a potential risk to persons or property which may result in health hazard or grave property damage.

CAUTION!Indicates a potential risk to property which may result in property damage.

Tab. 1: Design of safety notes

IntroductionHow to use these operating instructions

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1.1.3.2 Design for other notesNotes not referring to personal injury or property damage are used as follows:

Pictogram Descriptor Reference toNOTE Supplementary assistance or further useful information.

ENVIRONMENT Proper disposal.

Tab. 2: Design for other notes

1.1.4 Symbols usedSymbols are attached to products, type plates and packaging.

Symbols IdentificationLabelling for Class I products, developed and marketed in compliance with Medical Device Directive 93/42/EEC.

Labelling in compliance with the IEC 60601-1 standard. Symbol for "Follow Operating Instructions".

Symbol for the maximum load capacity of 50 kg (25 Nm) of the fastening clamp.

Packaging label. Symbol for "Keep dry".

Packaging label. Symbol for "Fragile! Handle with care".

Packaging label. Symbol for "Top".

Labelling in compliance with the ISO 15223-1 standard. Symbol for "Temperature limitations".

Labelling in compliance with the ISO 15223-1 standard. Symbol for "Relative humidity".

IntroductionDisposal

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Symbols Identification

Labelling in compliance with the ISO 15223-1 standard. Symbol for "Atmospheric pressure".

Labelling in compliance with the ISO 15223-1 standard. Symbol for "Product number".

Labelling in compliance with the ISO 15223-1 standard. Symbol for "Name and address of the manufacturer as well as date of manufacture".

Tab. 3: Symbols

1.2 Disposal

1.2.1 GeneralUsed products or parts thereof may be contaminated. To prevent potential infection, please clean and disinfect the product prior to return/disposal.

1.2.2 PackingThe packing is made of materials compatible with the environment. ATMOS will dispose of the packing materials upon request.

1.2.3 ATMOS productsATMOS will take back used products or those which are no longer in service.Please contact your ATMOS representative for more detailed information.

IntroductionEQUIPMENT RAILS

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1.3 EQUIPMENT RAILS

1.3.1 Overview of equipment rail

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3

2

46

5

Fig. 1: Overview of equipment rail

1 End cap 4 Clamping collar2 Equipment rail 5 Clamping bolt3 Cover cap 6 Earth terminal with cable shoe and toothed

washers

1.3.2 Use in accordance with the intended purposeThe product satisfies the basic requirements set forth in Annex I to the 93/42/EU Directive drafted by the Medical Products Council (Medical Products Directive) as well as the applicable national (German) codes and the Medical Products Act in Germany. In accordance with this directive the product may only be used by persons who have been instructed how to use this product by an authorised person. This product is to be used exclusively for human medicine.

AccessoriesAccessories or combinations of accessories may be utilised only as and when indicated in these operating instructions. Use other accessories, combinations and parts subject to wear only if these are intended expressly for the application and will not adversely affect performance features or safety requirements.

1.3.3 Applicable standardsThe product satisfies the basic requirements set forth in Annex I to the 93/42/EU Directive drafted by the Medical Products Council (Medical Products Directive) as well as the applicable national (German) codes and the Medical Products Act in Germany. This is certified by compliance with


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harmonised standards such as IEC 60601-1 and related standards and the respective special sections.

1.3.4 Intended purpose

Name: Equipment rails

Main function: Mounting equipment where the intended purpose is the fixation to equipment rails 25 x 10 mm

Medical indications / application:

Fixation of medical equipment

Specification of the main function:

The equipment rails 25 x 10 mm may be used as follows:• Mounting equipment which is equipped with a rail clamp for

equipment rails 25 x 10 mm• Mounting of rail clamps for equipment rails 25 x 10 mm• Mounting equipment whose intended purpose is to be mounted

to equipment rails 25 x 10 mm.The maximum vertical load of 50 kg (corresponds to 25 Nm) per bolt may not be exceeded in use.

User profile: Doctor, medically trained staff

Patient groups: No direct use on patients

Application organ: Not applicable

Application time: Not applicable

Application site: The application site is the clinical environment and doctor’s practices. The application of the product may only be performed by medically trained and introduced staff.

Contraindications: The equipment rails may not be used:• Outside the medical sector• In MR areas• In the home care sector• In operation without connection to equipotential bonding system• For connection of equipotential bonding of devices• If the maximum load is exceeded• If these are not mounted in a horizontal position or the holes in

the fastening straps are not aligned vertically• For mounting to ceilings or unsuitable surfaces

The product is: Not active

Sterility: No sterile product

Single-use product / reprocessing:

For information on reprocessing and cleaning please see the operating instructions.


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1.3.5 Versions

1.3.5.1 Equipment rails with fixed lengths• Equipment rail (REF 5750 7974) Length 1 m; 2 clamping bolts• Equipment rail (REF 5750 7975) Length 2 m; 4 clamping bolts• Equipment rail (REF 5750 7976) Length 3 m; 6 clamping bolts

1.3.5.2 Equipment rail with variable lengthsThe equipment rails with variable lengths may be ordered with holes for mechanical connection.• Equipment rail (REF 5752 0572) Length 0 - 0.99 m; 2 clamping bolts• Equipment rail (REF 5752 0572) Length 0 - 0.99 m; 2 clamping boltsEquipment rail (REF 5752

0573) Length 1.50 m; 3 clamping bolts• Equipment rail (REF 5752 0572) Length 0 - 0.99 m; 2 clamping boltsEquipment rail (REF 5752





0519) Length 4.00 m; 8 clamping bolts

Safety notesEQUIPMENT RAILS

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2 Safety notesDANGER!Potentially fatal due to electrical shock!Ensure potential equalisation for every mounted equipment rail.Test the potential equalisation before start-up.

DANGER!Defective device! Using incorrect spare parts or accessories can cause injuries or equipment failure.Only use original accessories or spare parts.

WARNING!Risk of injury!Risk of crushing during the assembly of individual components. Always ensure that nobody will be crushed.

WARNING!Risk of injury!The maximum load that may be placed per equipment rail is 50 kg (25 Nm) per bolt.

WARNING!Risk of injury! When the equipment rail is extended, the maximum load is limited to 25 kg per connecting plate.The maximum load of 25 kg per connecting plate may not be exceeded.

WARNING!Risk of injury!Do not use the equipment rail which is connected to the potential equalisation system for potential equalisation purposes for devices requiring potential equalisation.

CAUTION!Property damage!Equipment rails are partially made of magnetic materials. Do not use equipment rails in areas where excessive magnetism is produced.

MountingScope of delivery

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3 Mounting

3.1 Scope of delivery• Cover caps, dowels and wood screws (quantity according to the length of the equipment rail

and the number of clamping bolts)• 2 end caps,• 1 cable shoe,• 1 equipment rail,• 2 toothed washers,• 1 cheese head screw.

3.2 Equipment rail

WARNING!Risk of injury!Equipment rails are not suitable for mounting to ceilings or biased surfaces. Wall mounting may only be performed if the surfaces are sufficiently durable.If the characteristics of the surface are not known, the equipment rail may only be mounted after proper inspection of the durability.

CAUTION!Property damage!The equipment rail is designed for horizontal assembly only.The holes in the clamping collars must be adjusted vertically.

WARNING!Risk of injury!Only skilled staff is authorized to mount the bed curtain to the wall.

NOTEWe recommend mounting the upper equipment rail at a height of 1400 mm and the lower equipment rail at a height of 600 mm.

Before mounting, proceed as follows: Check the wall's static suitability for mounting. Check the wall for concealed lines or pipes (electricity, water, gas). Use the enclosed dowels only for brickwork or concrete walls. Use other, suitable mounting material for perforated bricks, hollow blocks or "system Anke" hollow blocks, and for prefabricated or plasterboard walls.

MountingPotential equalisation

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Fig. 2: wall breakthrough

Mounting the equipment rail Choose the position of the equipment rail in such a way that the wall breakthrough (1) for the potential equalisation cable is on the left of the clamping bolt (2) with a gap of approximately 30 mm to the centre of the bolt.

1

23

Fig. 3: Mounting the equipment rail

In the wall, drill the holes (ø 12 mm) for clamping collars and push dowels into the holes. Push the equipment rail (1) with clamping collars (2) up against the wall. Fasten the equipment rail by tightening the wood screws (M8x70) (3).

3.3 Potential equalisation

NOTEIf the length of the potential equalisation cable between the earth terminal and wall breakthrough is 10 cm, the potential equalisation cable will be covered completely when the cover caps are mounted.

MountingCover caps

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3

2

1

4

Fig. 4: Screwing in the earth terminal

Screwing in the earth terminal Connect the potential equalisation cable (1) using the cable shoe (2). Screw the earth terminal (3) into the thread (4) on clamping collar.

3.3.1 Turning the clamping collar (optional)The clamping collar and spacer are supplied in mounted condition. If required, the clamping collar may be turned by 180°.

2

1

Fig. 5: Turning the clamping collar

Undo the countersunk screw (M10x20) (1) on the clamping collar. Turn the clamping collar (2) by 180°. Tighten the countersunk screw (M10x20) with a torque of 10 Nm.

3.4 Cover caps

NOTEMount cover caps only after the load test is completed. Mount the cover caps with indication signs showing the load on every second clamping collar, beginning with the first clamping collar on the left side.

MountingMechanical connection

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1

2

1

Fig. 6: Mounting the cover caps

Mounting the cover caps Fit the cover caps (1) from above and from below onto the clamping collars (2).

Clamping collar, wall breakthrough and potential equalisation cable are hidden by the cover caps.

3.5 Mechanical connectionA mechanical connection is used to extend two equipment rails. The equipment rails with variable lengths may be ordered with holes for mechanical connection.

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2

1

34

5

6

Fig. 7: Mounting the mechanical connection

Mounting the mechanical connection Remove the end caps (1) from the equipment rails. Insert the mechanical connection (2) into the hollow space of the first equipment rail (3). Tighten the mechanical connection with a screw (M6x8) (4). Insert the other end of the mechanical connection into the hollow space of the second equipment rail (5). Tighten the mechanical connection with a second screw (M6x8) (6).

The mechanical connection is mounted. Equipment rails are connected.

3.6 Acceptance report

NOTEThe correct assembly of the equipment rail must be documented by a written acceptance report. The connection of the potential equalisation cable must be recorded in the acceptance report. Mechanical resistance must be proved by a load test, in which the maximum loads approved by MAQUET are mounted with a safety factor of 1.5. The acceptance report must be signed by the relevant engineer and filed with the room lists. Acceptance report see appendix.

Cleaning and disinfectionSafety notes

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4 Cleaning and disinfection

4.1 Safety notes

NOTEWipe the product with disinfectant after each use.

NOTEBe absolutely sure to follow the instructions for use provided by the manufacturer of the cleaning and disinfectant agent.

4.2 Cleaning of equipment components

CAUTION!Improper cleaning can cause property damage!Use only as much cleaning agent or liquid as is absolutely necessary and use a dry cloth to remove any excess cleaning agents and liquid.

The product must be cleaned before disinfection. Clean product parts thoroughly and remove tenacious contaminations with a cloth and dishwashing detergent. Use only all-purpose cleaners which are slightly alkaline (soap solution) and which contain tensides or phosphates as the active cleaning ingredients. Use a cloth moistened with water to thoroughly wipe down all the unit's components. Perform a wipe-disinfection of the product after every cleaning. Dry product parts immediately in order to inhibit the growth of germs on the surface.

4.3 Disinfection

DANGER!Risk of injury!Disinfectants may contain substances hazardous to health, which may cause injuries on contact with skin and eyes. Protect your skin and eyes, and strictly follow hygiene guidelines when working with disinfectants. Follow the instructions of the disinfectant manufacturer and the hygiene specialist.

WARNING!Risk of injury!Do not use any disinfection agents that would jeopardize patients, personnel or the functionality of the product.• Do not disinfect with phenoles or agents that split halogen, chlorine or oxygen;• Do not disinfect with solvents (benzene, thinner);• Do not spray-disinfect.

Cleaning and disinfectionDisinfection

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CAUTION!Property damage!If used over an extended period of time, alcohol-based disinfectants can damage surfaces and accessories.

Disinfectant agents which have been approved for use:Use only instrument and surface disinfectants with the following combinations of active ingredients:• Aldehydes• Quarternary compounds or• Guanidine derivatives.

Disinfectants which are not approved for use:• Pure hand disinfectants, since these usually contain alcohol or compounds of

alcohol• Disinfectants containing alcohol, since alcohol applied in excess (i.e.

accumulations of liquids containing alcohol remaining on the surface for more than about 5 minutes) can damage the surface.

Aldehydes, quaternary compounds and guanidine derivatives will not attack surfaces and will pass recurring hygiene inspections. Thanks to the markedly longer evaporation period and extended residence of the disinfectant agent on the surface, germicidal effect beyond 95 % is achieved within a few minutes, provided that coarse soiling is removed beforehand. Please refer to the following list for information on active ingredients.

Ingredient group Active ingredientsAldehydes 2-ethyl-1-hexanal, formaldehyde, glutardialdehyde, glyoxal,

o-phthaldialdehyde, succinaldehyde

Quarternary compounds Alkyl-didecyl-polyoxethyl ammonium propionate, alkyl-dimethyl-alkylbenzyl ammonium chloride, alkyl-dimethyl-ethyl ammonium chloride, alkyl-dimethyl-ethylbenzyl ammonium chloride, benzalkonium propionate, benzalkonium chloride (alkyl-dimethyl-benzyl ammonium chloride, coco-dimethyl-benzyl ammonium chloride, lauryl-dimethylbenzyl ammonium chloride, myristyl-dimethyl-benzyl ammonium chloride), benzethonium chloride, benzyl-dihydroxyethyl-coco-alkyl ammonium chloride, dialkyl-dimethyl ammonium chloride (didecyldimethyl ammonium chloride), didecyl-methyl-oxyethyl ammonium propionate, mecetronium-ethyl sulfate, methyl-benzethonium chloride, n-octyl-dimethyl-benzyl ammonium chloride

Guanidine derivatives. Alkyl-biguanide, chlorhexidine-digluconate, cocospropylene-diamine guanidinium diacetate, oliogomeric biguanide, polyhexamethylene biguanide hydrochloride (oligo-diimino imiodo-carbonyl imino-hexamethylene, polyhexanide)

Tab. 4: Active ingredients in disinfectants

MaintenanceGeneral

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5 Maintenance

5.1 GeneralMaintenance, repairs and period tests may only be carried out by persons who have the appropriate technical knowledge and are familiar with the product. To carry out these measures the person must have the necessary test devices and original spare parts.ATMOS recommends: Work should be carried out by an authorized ATMOS service partner. This ensures that repairs and testing are carried out professionally, original spare parts are used and warranty claims remain unaffected.

5.2 RepairsIf defects are detected the product may not be used any longer.Make a note of the deficiencies and the REF number on the data plate and inform the responsible ATMOS Service.Observe the information in chapter Sending in the device [ page 18].

5.3 Service hotline:+49 7653 689-0

5.4 Sending in the device Remove and properly dispose of consumables. Clean and disinfect the product and accessories according to the operating instructions. Place used accessories with the product. Fill in the form QD 434 „Delivery complaint / return shipment“ and the respective decontamination certificate.

This form is enclosed with each delivery and can be found at www.atmosmed.com. The device must be well padded and packed in suitable packaging. Place the form QD 434 „Delivery complaint / return shipment“ and the respective decontamination certificate in an envelope. Affix the envelope to the outside of the package. Send the product to ATMOS or to your dealer.

Technical specificationsGeneral

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6 Technical specifications

6.1 General

Classification as per Medical Products Directive 93/42/EEC

Class I

Dimensions of rail profile 25 x 10 mm

Rounding off on edges R = 1 mm

Vertical load (for equipment rail with fixed length/on the narrow side)or bending torque

50 kg / bolt

or25 Nm / bolt

Complete dead weight Approximately 1.4 kg

Cross section of potential equalisation cable 4 mm2

Outer diameter of dowel for concrete / stone wall (= nominal diameter of drill)

12 mm

Distance between wall and equipment rail 42 mm

Distance between bolts for equipment rail with fixed length(REF 5750 7974, REF 5750 7975, REF 5750 7976)

500 mm

Fig. 8: Distance between equipment rail and wall

6.2 Ambient conditions

Temperature -20 °C to +60 °C (shipping)

0 °C to +40 °C (in operation)

Relative humidity 10 % to 95 % (shipping)

30 % to 75 % (in operation)

Atmospheric pressure 700 hPa to 1060 hPa (shipping)

700 hPa to 1060 hPa (operation)

Accessories and spare partsAccessories

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7 Accessories and spare parts

7.1 Accessories

Mechanical connection 5750 7985

Tab. 5: Accessories

7.2 Spare parts

End cap 5750 1368

Tab. 6: Spare parts

Acceptance reportThe following tests were performed

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8 Acceptance reportNOTEThe acceptance report of the equipment rail is only valid in conjunction with the room list.

8.1 The following tests were performedThe following tests were performed

1 Inspection of type plate

2 Potential equalisation connectedThe user must check potential equalisation before start-up and certify the completion of the test accordingly

3 Checking mechanical property after installation with 150 N vertical force and with a torque of 25 Nm for each clamping bolt

Room list, sheet 1 to

Present during test / Commissioner

Name Signature

Test by client Name Signature

Manufacturer:ATMOS MedizinTechnik GmbH & Co. KG Ludwig-Kegel-Str. 16 79853 Lenzkirch GERMANY Phone: +49 7653 689-0 www.atmosmed.com

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