ATMOS Record 55 DDS Operating Instructions Index 26 June 2020

Table of contents 1 1.1 1.2 1.3 1.4 1.5 1.6 1.7

Introduction...4 Notes on operating instructions...4 Explanation of pictures and symbols...5 Intended use...7 Function...7 Intended users...8 Scope of delivery...8 Transport and storage...9

2 2.1 2.2 2.3

Notes for your safety...10 General safety instructions... 10 Danger for users, patients, and third parties... 10 Avoiding damage to the device... 12

3 3.1

Setting up and starting up...13 Device overview... 13

4 4.1 4.2 4.3 4.4 4.5 4.6 4.7 4.8 4.9 4.10 4.11 4.12 4.13 4.14

Operation...14 Initial start-up... 14 Preparing the device... 14 Assembly of the DDS secretion canister... 14 Using the DDS splash protection... 14 Attaching/removing the DDS canister lid... 14 Inserting/removing the DDS bacterial filter / oversuction stop... 15 Attaching, closing, and opening the DDS secretion canister handle... 15 Attaching/removing the DDS secretion canister... 15 DDS secretion canister hose holder... 15 Inserting the DDS hose adapter... 16 Connecting the suction hose... 16 Suctioning... 16 DDS changeover docking station... 17 Options... 17

5 Reprocessing...18 5.1 Safety instructions for reprocessing... 18 5.1.1 General safety instructions... 18 5.1.2 Danger for users, patients, and third parties... 18 5.1.3 Avoiding damage to the device... 18 5.2 Preparing/completing reprocessing... 19 5.3 Preparing surfaces... 19 5.3.1 Overview... 19 5.3.2 Selecting process chemicals... 19 5.3.3 Pre-cleaning... 20 5.3.4 Wipe disinfection... 20 5.4 Reprocessing the accessories... 20 5.4.1 Overview... 20 5.4.2 Secretion canister system... 21 5.4.3 Hoses... 23 6 6.1 2



Maintenance and service...24 Periodic tests... 24

6.2 6.3 6.4

Function check... 24 Sending in the device... 24 Reprocessing by the manufacturer... 24

7 7.1

Troubleshooting...25 Troubleshooting... 25

8

Accessories...26

9

Consumables...27

10

Disposal...28

11

Technical data...29

12

Notes on EMC...30

13

Notes...31

Further information, accessories, consumables, and spare parts are available from:

ATMOS

MedizinTechnik GmbH & Co. KG Ludwig-Kegel-Straße 16 79853 Lenzkirch Germany Phone +49 7653 689-0 FAX

+49 7653 689-190 (Switchboard)

FAX

+49 7653 689-393 (Service)

E-mail: [email protected] Web:

www.atmosmed.de



3

1

Introduction

1.1

Notes on operating instructions These operating instructions contain important instructions on how to operate your product safely, correctly, and effectively. These operating instructions are designed for training and instructing new operating personnel in the use of the system, and also for use as a reference manual. This document may only be reprinted, either in part or in whole, with written permission from ATMOS. These operating instructions must always be kept available near the device. Care, periodic tests, regular cleaning, and proper use are essential. They ensure the operational safety and usability of the product. Maintenance, repairs, and periodic tests may only be carried out by persons who have the appropriate technical knowledge and are familiar with the product. The person in question must possess the test devices and original spare parts required to carry out these measures. Read chapter ‘Notes for your safety’ on page 10 before using the product for the first time. This will help you to avoid potentially dangerous situations. The product bears CE marking CE 0124 according to the EC directive 93/42/EEC of the council for medical products and meets the basic requirements of appendix I of this directive. The product complies with all applicable requirements of Directive 2011/65/EU on the restriction of the use of certain hazardous substances in electrical and electronic equipment (“RoHS”). The Declaration of Conformity and our general standard terms and conditions can be viewed on our website at www.atmosmed.com. The quality management system at ATMOS has been certified according to international standard EN ISO 13485.

These operating instructions are valid for the following products:

4

Introduction

ATMOS Record 55 DDS

REF 444.0910.0

ATMOS Record 55 DDS 100 V

REF 444.0910.1

ATMOS Record 55 DDS 115 V

REF 444.0910.2

ATMOS Record 55 DDS 127 V

REF 444.0910.3

ATMOS Record 55 DDS (2 x 3 l secretion canister)

REF 444.0930.0

ATMOS Record 55 DDS (2 x 5 l secretion canister)

REF 444.0940.0

1.2

Explanation of pictures and symbols

In the operating instructions DANGER Warning of a danger that will result in immediate fatal or serious injury. Observe the necessary measures. WARNING Warning of a danger that can cause fatal or serious injury. Observe the necessary measures. CAUTION Warning of a danger that can cause minor injury. Observe the necessary measures. ATTENTION Notice of a danger that can damage the product or other objects. Observe the necessary measures. Warning of a danger that can cause fatal or serious injury.



Useful information on the handling of the device.

1.

Action. Proceed step by step.

»

Result of an action. Move in this direction, plug in.

On device and type plate

Follow operating instructions (blue) Observe the operating instructions Warning; take extra care to observe 0124

This product complies with the relevant requirements of the EU Directives. This product complies with the relevant requirements of the EU Directives. Foot switch Manufacturer Manufacturing date

Introduction

5

GOST Certificate (Russia)

Eurasian conformity SN

Serial number

REF

Order number

EAN

European Article Number

IPX1

Protection against the ingress of damaging moisture (dripping water) Applied part type BF Professional disposal For single use only (symbol located on consumables)

NON STERILE

AUTOCLAVE

PATIENT

Not sterile Autoclavable Connection for suction hose/patient Potential equalisation Protection class II Fuse Alternating current On, connected to the power supply

AP

6

Introduction

Class AP (for use in potentially explosive areas)

1.3

Intended use

Main function:

Suction of secretions, blood, serous fluids, rinsing fluids, and for the temporary collection of these fluids.

Medical indications / application:

For all applications where suction is needed, such as in general surgical procedures (e.g., suction of wound cavities, abscesses), the nasopharyngeal cavity, for endoscopy, for suction of secretion or rinsing fluids, and in neurosurgery. For subcutaneous liposuction.

Specification of the main function:

For the drainage and temporary collection of body fluids. By means of an electric suction pump, a negative pressure is created. An additional secretion canister must be attached to allow the temporary collection of drained body fluids.

User profile:

Doctors, medical support staff without restrictions.

Patient groups:

Patients of all ages with and without restrictions.

Application organ:

Natural orifices as well as openings that result from a surgical intervention (entire body of humans and animals).

Application time:

For short-term use on patients (< 30 days)

Area of application:

The application site is the clinical, outpatient, and veterinary field. The device may only be used by persons who have received the relevant training and instruction.

Contraindications:

Not suitable for: • Drainage operations in the low-vacuum range (e.g., thoracic or wound drainage) • Use outside the medical sector • Suction of flammable, corrosive, or explosive substances • Suction in potentially explosive atmospheres • Not suitable for use as a vacuum extraction system

The product is:

Active

Sterility:

No sterile product

Single-use product/ re-sterilisation:

The device and parts of the accessories are reusable. Information on reprocessing, cleaning, and disinfection can be found in this document.

1.4

Function

The ATMOS Record 55 DDS is a mains-operated surgical suction device, the core of which is a high-performance, maintenance-free diaphragm pump. It generates vacuum in the hose and rinsing canister system which assists in drawing off and collecting the

Introduction

7

secretions. Via a vacuum regulator with vacuum gauge, the final vacuum and thus the desired suction capacity can be precisely adjusted. Several secretion canisters of different sizes are available for secretion collection. The reusable secretion canister can be mounted to the ATMOS Record 55 via the Direct Docking System. The user can connect the suction hose directly. A hydrophobic bacterial filter located in the lid of the canister prevents bacteria and liquids from entering the pump. This filter protects the device against oversuction. The intake located in the hose connection prevents foaming in the secretion canister and therefore ensures a longer filter life.

1.5

Intended users

May only be used by trained professionals in supervised and medical operations.

1.6

Scope of delivery

Basic device ATMOS Record 55 DDS

8

Introduction

ATMOS Record 55 DDS (230 V, 100 V, 115 V, 127 V)

REF

1x power cable 5 m

008.0629.0

1x hose holder

443.0003.0

ATMOS Record 55 DDS (2 x 3 l secretion canister)

REF

1x power cable 5 m

008.0629.0

1x hose holder

443.0003.0

2x DDS secretion canister, plastic 3 l, autoclavable

340.0051.0

2x DDS canister lid with sealings, autoclavable

340.0053.0

2x DDS canister handle, grey, autoclavable

340.0055.0

2x DDS splash protection, silicone, autoclavable

340.0056.0

1x DDS hose adapter set (Ø 6 mm + Ø 10 mm), autoclavable

340.0057.0

12x DDS bacterial filter

340.0054.0

1x suction hose (silicone), Ø 6 mm, L = 2 m

000.0361.0

ATMOS Record 55 DDS (2 x 5 l secretion canister)

REF

1x power cable 5 m

008.0629.0

1x hose holder

443.0003.0

2x DDS secretion canister, plastic 5 l, autoclavable

340.0052.0

2x DDS canister lid with sealings, autoclavable

340.0053.0

2x DDS canister handle, grey, autoclavable

340.0055.0

2x DDS splash protection, silicone, autoclavable

340.0056.0

1x DDS hose adapter set (Ø 6 mm + Ø 10 mm), autoclavable

340.0057.0

12x DDS bacterial filter

340.0054.0

1x suction hose (silicone), Ø 6 mm, L = 2 m

000.0361.0

1.7

Transport and storage

Only transport the device in a shipping carton that is padded and offers sufficient protection. If damage occurs during transport: 1. Document and report damages in transit. 2. Send the device to ATMOS; see chapter 24‘6.3 Sending in the device’ on page 24. Ambient conditions for transport and storage: • Temperature:

−30...+50 °C

• Relative humidity:

5...90% without condensation

• Air pressure:

700 ...1060 hPa

Introduction

9

2

Notes for your safety

2.1

General safety instructions

Only a fully functional product meets the safety requirements of users, patients, and third parties. Therefore, observe the following instructions on your product: Please read and pay attention to the safety instructions prior to using the product.

2.2

Danger for users, patients, and third parties

WARNING Choking hazard for children due to accessories! Children can strangle themselves or choke on small parts. •

Keep children away from hoses and connection cables.

•

Keep children away from swallowable small parts. Examples of such swallowable small parts are the fingertip and sealing ring. CAUTION

Explosion and fire hazard! Burns and injuries are possible. •

Never suction any explosive, flammable, or corrosive gases or liquids. Please observe the intended use in chapter ‘1.3 Intended use’.

•

Never operate the product in potentially explosive areas or areas that are oxygenated.

•

Only use original accessories and original spare parts from ATMOS. WARNING

Your patient can be severely injured. Avoid misuse. •

The product may only be used by medically trained persons who have been instructed in the handling of the medical suction system.

•

The product may only be used by qualified personnel in supervised operation.

•

Select the vacuum according to the patient and the application.

•

Observe the valid guidelines.

•

Always set up the unit in such a way that the operating elements are in clear view and within easy reach of the operator. The device must be set up on a stable, level surface.

10 Notes for your safety

WARNING Ensure that the device is always functional and ready for use. Your patient could suffocate. •

Before connecting the device, check whether the required mains voltage on the device matches the mains voltage of the mains power supply.

•

Position the device in an easily accessible location and keep access free.

•

Make sure that the power cable is working. Replace defective accessories immediately.

•

Remove the transport protection on the bottom of the device prior to first use.

•

ATMOS recommends always having another suction device ready at hand. That way you can also perform suctioning if a device should fail. WARNING

Risk of infection due to pathogens on the product! Deadly diseases may be transmitted. •

Always wear disposable gloves if you might come into contact with secretion.

•

Always wear disposable gloves when using the product.

•

Never use components that are marked with are intended for single use only.

•

Sterile-packed parts may only be used if the packaging is undamaged.

•

Do not operate the device without a bacterial filter.

•

A suction catheter, hose-rinsing aperture, or medical suction set must always be connected to the hose. The suction hose must never come into direct contact with the suction area.

•

Clean and disinfect the product after every use.

•

Clean and disinfect the product according to the operating instructions.

•

The product must not be used following oversuction.

more than once. These components

WARNING Tripping hazard due to cables. Injuries are possible. •

Lay connecting cables properly.

Notes for your safety 11

WARNING Electric shock due to unsuitable mains connection, incorrect handling of the product, or damaged product components Burns, cardiac arrhythmias, and even fatal injury are possible. •

Prior to each use, check for damage to the device and the power cable. Do not operate the device if you notice any damage. In this case, clean and disinfect the device and send it to ATMOS for repair.

•

Disconnect the device from the mains power supply prior to cleaning or disinfection.

•

You an only disconnect the device by removing the power plug from the mains power supply.

•

Position the device in such a way that you can easily disconnect it from the mains power supply at any time.

•

Only connect the device to a mains power supply with a protective conductor.

•

Never touch the plug or power cable with wet hands.

•

Only use the power cable in dry surroundings. The surroundings must be non-conductive.

•

Ensure that no liquid penetrates the device. If liquid has entered the device, operation of the device must cease immediately. In this case, clean and disinfect the device and send it to ATMOS for repair.

•

Only use proper power cables and extension cords.

•

Never touch the device's interfaces and the patient at the same time!

•

Only use original accessories and original spare parts from ATMOS.

•

Pay attention to the periodic tests in chapter ‘6 Maintenance and service’.

•

Assembly, new settings, alterations, extensions, and repairs may only be carried out by authorised persons.

•

Do not modify the device without the manufacturer’s permission.

2.3

Avoiding damage to the device

ATTENTION Storage and operation in an unsuitable environment. The product may become damaged. •

Please observe the ambient conditions regarding transport, storage, and operation.

•

After transporting the device at low temperatures, keep it at room temperature for at least six hours before initial start-up. If the device is not acclimatised, it may not be used, as the diaphragm of the pump could become damaged.

12 Notes for your safety

3

Setting up and starting up

3.1

Device overview

Front view

 Vacuum gauge  Vacuum regulator  On/off switch  DDS canister handle  DDS canister lid  DDS secretion canister  Connection for the foot controller or foot switch (optional)

Rear view

 Connection for potential equalisa  

tion  Equipment safety fuse  Mains supply

Vacuum connection: Direct Docking System & The vacuum connection between the pump and secretion canister system is immediately established when the DDS canister is attached!

Risk of injury and risk of infection due to production residues. 1. Prior to first use, prepare the product according to the operating instructions.

Setting up and starting up 13

4

Operation

4.1

Initial start-up

& Observe the safety instructions prior to initial start-up! & Remove the transport protection on the bottom of the device by loosening the two Allen screws marked in red. & The transport protection screws must be inserted again before returning the device. & After transporting the device at low temperatures, it should be kept at room temperature for at least six hours before initial start-up; otherwise, the device may not be operated.

4.2

Preparing the device

• Check whether the voltage and frequency data listed on the device correspond to the values of the mains power supply and then connect it to the mains. & For surgical procedures, we recommend additionally connecting the device via the connection to the potential equalisation of the examination room. »

The device is now ready for use.

4.3

Assembly of the DDS secretion canister 

 DDS secretion canister handle  DDS bacterial filter

 

 DDS hose adapter



 DDS canister lid



 DDS splash protection  DDS secretion canister



4.4

Using the DDS splash protection 1. Attach the splash protection to the pipe connection in the DDS canister lid. & The splash protection protects the DDS bacterial filter from becoming wetted prematurely by liquids and/or foam formation.

4.5

Attaching/removing the DDS canister lid

1. Place the DDS secretion canister on a firm surface and set the DDS secretion canister lid horizontally on it (the lid cannot be turned incorrectly). 2. Gently press the DDS canister lid with both hands onto the secretion canister.

14 Operation

3. To open the DDS canister lid, hold it on the reinforcement bars of the mounting fixture and then pull the DDS canister lid up and off by reaching into the opening for the filter.

4.6

Inserting/removing the DDS bacterial filter / oversuction stop The DDS bacterial filter / oversuction stop are disposable products. & Before each use, check whether the DDS bacterial filter / oversuction stop is dry and clean. Replace the DDS bacterial filter with a new DDS bacterial filter if it is discoloured or contaminated or if oversuction has occurred. 1. Insert the bacterial filter into the DDS secretion canister handle.

4.7

Attaching, closing, and opening the DDS secretion canister handle 1. To attach the DDS secretion canister handle, insert it into the grooves of the canister lid (with the locking latches open). 2. To close the DDS secretion canister handle, clip the locking latches under the canister rim. Then press the clips towards the secretion canister until they click into place. 3. To open, pull the clips outwards and remove the locking latches from under the canister rim.

4.8

Attaching/removing the DDS secretion canister 1. To attach the DDS secretion canister, allow it to slide vertically downwards into the mounting fixture. 2. To remove the DDS secretion canister, lift it straight up.

4.9

DDS secretion canister hose holder 1. If using a DDS secretion canister hose holder, attach it between the canister lid and the hose adapter.

Operation 15

4.10 Inserting the DDS hose adapter 1. Insert the DDS hose adapter (Ø 6 or 10 mm) into the ‘Patient’ opening on the DDS canister lid. 2. Turn it slightly and press it down. & The adapter can be removed again by turning it slightly.

4.11 Connecting the suction hose & Connect the suction hose to the already inserted hose adapter.

4.12 Suctioning 1. Please ensure that the following parts have been reprocessed prior to treating a new patient: • Suction hose including hose-rinsing aperture or suction instruments • DDS secretion canister system including DDS canister lid and DDS hose adapter 2. Prior to each use, check whether the DDS bacterial filter was inserted during cleaning and disinfection. 3. Replace the bacterial filter with a new bacterial filter if it is discoloured or contaminated, or if oversuction has occurred. 4. Switch on the device. 5. Close the suction hose and set the desired vacuum. 6. Connect the suction catheter, hose-rinsing aperture, or suction instruments. & Observe the liquid level in the secretion canister during suction. The DDS bacterial filter prevents liquid from being sucked into the pump. Nevertheless, the secretion canister should be emptied or replaced when it is 2/3 full (including foam crown). & If liquid has been sucked into the pump despite the bacterial filter, the device may not be operated again until it has been checked by an authorised service partner.

16 Operation

4.13 DDS changeover docking station & The maximum load of the station is 15 kg; higher loads may damage the device! The DDS changeover docking station is used if two secretion canisters are required. The changeover lever serves to switch the vacuum to the secretion canister being used. When removing or attaching a secretion canister, switch the lever towards the second secretion canister.

4.14 Options Foot switch REF 443.0755.0 Pneumatically explosion-proof switch for switching the device on and off. 1. Connect the foot switch. 2. Set the main switch in the control panel to foot switch operation (OFF). 3. Pressing the foot switch turns the device on. 4. Pressing the foot switch again turns the device off. 5. If the main switch in the control panel is set to continuous operation (ON), the foot switch produces no effect.

Foot controller REF 443.0770.0 For regulating the vacuum. Connect the foot controller (remove the protection cap and tighten the nut on the foot controller hose). 1. To increase the vacuum, press the pedal down. 2. When you lift off your foot, the controller locks in that position.

Operation 17

5

Reprocessing

5.1

Safety instructions for reprocessing

5.1.1 General safety instructions We recommend that you always document all maintenance work and part replacements in writing. It is the responsibility of the user to ensure that the demands for cleaning and disinfection are adhered to. Generally, validation and routine monitoring of the procedure will be necessary. Reprocessing may only be carried out by persons who have the necessary expertise. The person in question must have the necessary equipment to carry out these measures.

5.1.2 Danger for users, patients, and third parties Risk of infection due to unsuitable accessories. Deadly diseases may be transmitted. •

Always wear your own personal protective gear. The protective gear consists of protective gloves, protective clothing, goggles, and mouth and nose protection for all steps in which the product components are still contaminated.

•

Only use aids that can be easily reprocessed or ones that are disposable products.

Risk of infection due to unsuitable reprocessing. Deadly diseases may be transmitted. •

Make sure that all areas of the accessories can be easily reached.

•

Only use suitable load carriers for mechanical reprocessing. This especially applies to accessories with hollow spaces and lumens that are hard to reach.

•

Make sure that air bubbles do not form in the hollow spaces and lumens of accessories when placing them in processing solutions.

5.1.3 Avoiding damage to the device Damage to the device due to cleaning with fixatives. Stains cannot be removed permanently. •

Do not use aldehydes before and during cleaning.

•

Do not expose the product to temperatures > 40 °C / 104 °F before and during cleaning.

Unsuitable aids. & Follow the corresponding operating instructions of all aids and devices used.

18 Reprocessing

Unsuitable cleaning agents and disinfectants. The product may become damaged. •

Do not use any process chemicals containing the following ingredients on plastic parts: • Chloramides or phenol derivatives

•

Do not use any process chemicals containing the following ingredients on stainless steel: • Organic or inorganic bases • Alkaline solutions

Incorrect mechanical cleaning and disinfection. Corrosion due to moisture. •

Remove the products immediately after the programme is finished.

5.2

Preparing/completing reprocessing

Prior to reprocessing 1. Disassemble the product for reprocessing into the following items: • Device • Hoses • Secretion canister system After reprocessing 1. Perform a function check.

5.3

Preparing surfaces

Surface Housing

After each application After each patient Daily Weekly Every 14 days Monthly Pre-cleaning Wipe cleaning Wipe disinfection Spray disinfection

5.3.1 Overview

x

x

Remarks

x

5.3.2 Selecting process chemicals

Cleaning agent (manufacturer) Active ingredients in 100 g

Type

Housing

Always observe the manufacturer’s specifications for the process chemicals.

Disinfection

Reprocessing 19

Housing

Cleaning agent (manufacturer) Green & Clean SK (Metasys) Dismozon® plus (Bode Chemie) Kohrsolin® FF (Bode Chemie) Kohrsolin® extra (Bode Chemie) Perform® (Schülke & Mayr) Mikrobac® forte (Bode Chemie) Bacillol® 30 Foam (Bode Chemie) Incidin® Active (Ecolab) mikrozid® sensitive wipes (Schülke & Mayr)

Active ingredients in 100 g Type <1 g dialkyldimethylammonium chloride, <1 g alkyldimethylethylbenzylam- Foam monium chloride, <1 g alkyldimethylbenzylammonium chloride Ready to use 95.8 g magnesium monoperoxyphthalate hexahydrate Granulate

x x

5 g glutaral, 3 g benzyl-C12-18-alkyldimethylammonium chloride, 3 g didecyldimethylammonium chloride 14.1 g (ethylenedioxy)dimethanol, 5 g glutaral, 8 g didecyldimethylammonium chloride 45 g pentapotassium bis(peroxymonosulphate) bis(sulphate)

Liquid concentrate Liquid concentrate Powder

x

19.9 g benzyl-C12-18-alkyldimethylammonium chloride, 5 g N-(3-aminopropyl)-N-dodecylpropane-1,3-diamine 14 g ethanol, 10 g propan-2-ol, 6 g propan-1-ol, 0.5 g n-alkyl-aminopropyl-glycine Peracetic acid

Liquid concentrate Foam, ready to use Powder

x

x x

x x

0.26 g alkyl(C12-16)dimethylbenzylammonium chloride, 0.26 g dideWipes cyldimethylammonium chloride, 0.26 g alkyl(C12-14)ethylbenzylammonium chloride

x

5.3.3 Pre-cleaning 1. Disconnect the device from the mains power supply. 2. Clean the surface evenly with a suitable cloth and clear water. Pay particular attention to hard-to-reach areas. »

No more residue is visible.

5.3.4 Wipe disinfection Always observe the manufacturer’s specifications for the process chemicals.

5.4

Reprocessing the accessories

x x

Sterilisation

Pre-cleaning

x x

Manual cleaning and disinfection Mechanical cleaning and disinfection

Pre-treat

Monthly

Every 14 days

Weekly

x x

Daily

After each application

60 60

After each patient

Max. reprocessing cycles

Accessories

Disposable product

5.4.1 Overview

Secretion canister system

• •

20 Reprocessing

DDS secretion canister2 DDS canister lid2 & DDS secretion canister handle & DDS splash protection & DDS hose adapter

x x

x x