ATMOS S 61 Servant vision Operating Instructions Index 24 March 2018

Table of contents

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 +49 7653 / 689-493 (Service Center) [email protected] www.atmosmed.de

2

1.0 1.1 1.2 1.3 1.4

Introduction...3 Notes on operating instructions...3 Intended use...3 Function...4 Explanation of pictures and symbols...4

2.0

For your safety...5

3.0 3.1 3.2

Assembly: Connecting conditions...6 Required connections for all units of ATMOS® S 61 Servant ...6 Connection to electrical power line...6

4.0 4.1 4.2 4.4.3 4.4.4 4.4.5 4.4.6 4.4.7

Operation...7 Front view: Controls and options...7 Connections...8 On / off switch...8 Light modules and controls...9 Endoscope management...10 ATMOS® ENT camera...12 ATMOS® LED stroboscope...13

5.0 5.1 5.2 5.3 5.4

Cleaning and care...14 General information on cleaning and disinfection...14 Recommended instrument disinfectants...15 Recommended surface disinfectants...16 Recommended endoscope disinfectants...17

6.0

Hygienic plan...18

7.0 7.1 7.2

Maintenance and Service...20 Replacing the fuse...20 Sending in the device...20

8.0

Troubleshooting...21

9.0

Accessories...22

10.0

Technical data...23

11.0

Disposal...24

12.0

Notes on EMC...25

1.0

Introduction

1.1 Notes on Operating instructions These operating instructions contain important notes on how to operate the ATMOS® S 61 Servant vision safely, correctly and effectively. Their reading helps to avoid risks, and also to reduce repair costs and down-times. This increases, amongst other things, the reliability and service-life of the device. These operating instructions serve not only for new operating personnel to be instructed in its use, but also for use as a reference manual. Reprints (also in extracts) only with permission in written form by ATMOS. These operating instructions must always be kept available near the device. Care and period tests in conjunction with professional execution provide for operational safety and readiness for use of your ATMOS® S 61 Servant and are therefore a must besides regular cleaning. Repair work and period tests may be carried out only by expert personnel authorised by ATMOS. By applying only original spare parts you will have the guarantee that operational safety, readiness for work and the value of your ATMOS® S 61 Servant vision will be preserved. • The product ATMOS® S 61 Servant vision bears CE marking CE according to the EC Directive of the council for medical products 93/42/EEC and meets the basic requirements of Appendix I of the directive. • The product ATMOS® S 61 Servant vision complies with all applicable requirements of the Directive 2011/65/EC restricting 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 obtained on our website at www.atmosmed.com. • The quality management system applied at ATMOS has been certified according to international standards EN ISO 13485. • Prior to start-up please peruse chapter 2.0 „For your safety“, in order to be prepared for any possible dangerous situations.

1.2 Indended use Name: ATMOS® S 61 Servant vision Main functions: ATMOS® S 61 Servant vision: • Light sources • Storage and heating of endoscopes • Visualization • Stroboscopy for larynx diagnostic Medical indications / application: Standard ENT examination and/or therapy Specification of the main function: ATMOS® S 61 Servant vision: • Light source LED for light guide • LED light source, 700 mA • Camera (ATMOS® Cam) • Stroboscope (ATMOS® Strobo 21 LED) User profile: Doctors and medical assistants Patient groups: Patients of all ages with and without restrictions Application organ: Mouth to pharynx, auditory canal to the ear drum and the nasal cavities

Application time: • ENT unit: Short term use (up to 30 days) • Suction / Compressed air / ear rinsing / light source: Temporary application on the patient (less than 60 minutes) Application site: Application sites are clinics and practices for ENT doctors and phoniatrists. The examination and/or therapy with the ENT unit may only be executed by medically trained persons. Contraindications: May not be used for irrigation of the paranasal sinuses. The ear irrigation should not be applied to an infected auditory canal or a perforated eardrum. The product is: active Sterility: The ENT unit is no sterile product. Single-use product / reprocessing: The ENT unit is intended for multiple use. The device and parts of the accessories are reusable. For information on reprocessing, cleaning and disinfection, please see the operating instructions.

3

1.0

Introduction

1.3 Function • Coldlight channels (LED) • Automatic activation over light barrier, headlight hook, microscope arm • Endoscope storage without/with heating • Disinfectant timer • Integration ATMOS® Cam • Integration ATMOS® LED Strobo • Instrument illumination

1.4 Explanation of pictures and symbols

Short cuts / symbols contained in this operating instructions Follow the arrows

■

General information

Move, plug... in this direction

Please press where dot indicates

●

Numeration

Turn, shift ... in this direction

→

Subnumeration

Please read, important information

Replace

Check click

Engage, check correct fit

Short cuts / symbols on the unit

!

Warning, special diligent notice

Fuse according to IEC 417/5016, DIN 30600/0186

Signal output

Ground wire connection

~

Alternating current

Signal input and output

On (feed-in, power connection)

Potential equalization

Foot switch

Off (feed-in, power connection)

Manufacturing date

Refer to the operating instructions

Manufacturer

Professional disposal

Application part type BF

4

Signal input

0124

This product complies with the relevant requirements of EU directives

2.0

For your safety

!

For your safety

• The ATMOS® S 61 Servant vision is produced according to IEC 601 / EN 60601 and listed in the following classes: -- VDE Class of protection 1 -- Class IIa (EEC 93/42). • The unit should not be positioned directly next to a wall, because of the ventilation openings on the rear side! Do not restrict the air supply at the rear of the unit! • Caution! Mirror and endoscope heaters may generate temperatures above 40°C! • Attention with the cold-light source! Because of the high energy of the light there is a large amount of heat emission at the point of the optical system. Avoid too small a distance between the tissue and the field of light emission of the light guide respective of the endoscope, as this may cause coagulation of the patient's tissue. When using the endoscope avoid the direct contact between area of light emission and the tissue. • Attention, Fire Hazard! Do never place the area of light emission from the light guide or from the endoscope onto heatabsorbing surfaces (dark pieces of cloth, etc.), because this will cause unacceptable high heating or even ignition of the material. Switch the light off when you do not require the light over a prolonged period of time. • Care is to be paid in respect to light sources when working with endoscopes. The intensity of the light is very high. Do not look directly into the light outlets! In case of possible light failure remove the endoscope from the working area. • Always make sure that you do not blind patients with the light source! Watch out that patients do not look directly into the light source! You should always avoid looking directly into the light source. > Damages to the eyes due to blinding may be the result. • Exclusively connect ATMOS® HL 21 LED and ATMOS® LS 21 LED to the connections for ATMOS® HL 21 LED and ATMOS® LS 21 LED. Unsuitable application parts may result in an electric shock or damage. Cardiac arrhythmia and even death are possible. • The ATMOS® S 61 Servant vision may only be used under the supervision of skilled staff who have been authorised by ATMOS and trained in its operation (IEC 601-1 / EN 60601-1).

• The mains voltage specified on the type plate must correspond with the data of the power supply system. • Make sure prior to every application of the equipment that it is technically safe and in proper condition. Damaged cables must be replaced immediately! • Never leave the patient unattended at the treatment unit. • Correct configuration in assembly of country-specific connections: -- green/yellow: protective conductor (PE) -- blue: neutral conductor (N) -- black or brown: phase • Please note: A medical insulating transformer with earth leakage monitor or any similar safety system acc. to EN 60 601-1 is required, if several devices are connected over one common power supply. The transformer must correspond to the power consumption of all the devices to be connected. • Do not place used contaminated instruments on the ENT unit! • The ambient conditions specified in the "Technical data" must be strictly observed! • Switch off main switch after finishing work in practice and close water supply, if present. • The ATMOS® S 61 Servant vision may be operated only in rooms used for medical purposes, but not in areas subject to explosion hazards and in oxygen rich environments. • The ATMOS® S 61 Servant vision meets the immunity to interference requirements of IEC 601-1-2 / EN 60601-1-2 „Electromagnetic Compatibility – Medical Electrical Devices“. • The ATMOS® S 61 Servant vision may not be operated with devices not complying with the requirements of standard EN 60601-1 „Medical Electrical Equipment“ and EN 60601-1-2 „Electromagnetic Compatibility“ (Medical Electrical Equipment). • ATMOS is not liable for personal injury and damage to property if -- no original ATMOS parts are being used, -- the advice for use in these operating instructions is not being observed, -- assembly, new settings, alterations, extensions and repairs have been carried out by personnel not authorised by ATMOS. • Never touch the device´s interfaces and the patient at the same time! • The unit may only be opened by a specialist authorised by ATMOS! • Please pay attention to the period tests in chapter 7.0 „Service and maintenance“ on page 20.

5

3.0

Assembly: Connecting conditions

These connection conditions refer to the overall unit with maximum equipment.

250

1730

445

<150

ca. 250

640

>350

740

1550

160

630 730 1961

979,5 2940

3.1 Required connections for all units of ATMOS® S 61 Servant Flexible multi-port distributors may not be used as a power supply for the ATMOS® S 61 Servant workstation, ATMOS® S 61 Servant vision or for an optional HF or radiofrequency surgical device. Unit / Device

Maximum required connections

ATMOS S 61 Servant ENT workstation

1 x earthing contact socket outlet

ATMOS® S 61 Servant vision

1 x earthing contact socket outlet (basic version) or 1 x fixed connection for the integrated camera or stroboscope LED

ATMOS® S 61 Servant instruments

3 x earthing contact socket outlet

Water separating system (WTA)

1 x earthing contact socket outlet

Monitor

1 x earthing contact socket outlet

Patient chair

1 x earthing contact socket outlet

®

An adequate number of socket outlets with earthing contact should be mounted for possible connection of further electrically operated units which may be installed (e.g. installation of an electrically operated ATMOS® patient chair, water separating system, camera, monitor, etc.)

3.2 Connection to electrical power line

6

Prerequisites • Installation acc. to IEC 60346-7-710: earth leakage circuit breaker (FI-circuit breaker) with rated leakage current <0.03 A • Connection of the power supply cable of the ATMOS® S 61 Servant vision to a safety socket outlet near the device, max. 3 meters, preferably left (fig.). This may only be carried out by authorized qualified personnel. • The supply circuit must be separated from other devices e.g. PCs etc. • If isolating transformers are used then isolation monitoring must be integrated in the isolating transformer. • Maximum power consumption: -- ATMOS® S 61 Servant workstation 2.300 VA -- ATMOS® S 61 Servant vision 200 VA -- ATMOS® S 61 Servant instruments 250 VA Flexible multi-port distributors may not be used as a power supply for the ATMOS@ S 61 Servant vision or ATMOS® S 61 Servant workstation.

4.0

Operation

First start-up Prior to shipment each ATMOS® S 61 Servant is being inspected by the manufacturer for function and safety. In order to make sure that the appliance is working safely after transport and installation, the following points should be observed: The user should put the appliance into operation only if 1. a functional test on the appliance at the place of operation has been carried out. 2. the operating instructions have been read and noticed. Following transportation at low temperatures the appliance must be held for up to fours hours at ambient temperature before first start-up. When the appliance has not been acclimatised the formation of condensation water is possible and a malfunction might be the result.

4.1 Front view: Controls and options at complete equipment

LED stroboscope

ENT camera (optional) Alternatively: ATMOS® LS 31 LED (see page 9)

Instrument deposit for 2 trays

Camera head Endoscope management for rigid, clean optics Disinfectant quiver

Light port Automatic light switching On / Off switch

Manual activation / deactivation of light ports

Activation disinfectant times

Display light module Adjustment of brightness resp. disinfectant timer Display of level of brightness resp. of time when switching on the disinfectant timer

7

4.0

Operation

4.2 Connections Foot switch ENT camera (optional) Foot switch LED stroboscope (optional) Microscope

Connection supply network (figure: fixed connection) Potential equalization

The LED light module has different connections depending on the configuration: Version 1: 2 connections for light guide 2 connections for ATMOS® HL 21 LED and ATMOS® LS 21 LED Version 2: 4 connections for light guide Version 3: 4 connections for ATMOS® HL 21 LED and ATMOS® LS 21 LED

1

2

3

4

Connections version 1: 1, 2

Connections for light guide

3, 4

Connections for ATMOS® HL 21 LED and ATMOS® LS 21 LED

!

Exclusively connect ATMOS® HL 21 LED and ATMOS® LS 21 LED to the connections for ATMOS® HL 21 LED and ATMOS® LS 21 LED. Unsuitable application parts may result in an electric shock or damage. Cardiac arrhythmia and even death are possible.

4.3 On / off switch After switching on the mains switch, all integrated and connected devices are ready for operation. → green light at mains switch: Mains voltage switched on When the device gets switched on, all LEDs are lit for a short while. Please check them each time you switch on the device.

8

4.0

Operation

4.4 Light modules and controls Light modules

ATMOS® HL 21 LED (optional): Headlamp ATMOS® Strobo 21 LED (optional): Stroboscope ATMOS® LS 31 LED (optional): LED light source for stroboscopy with light guide ATMOS® LS 21 LED (optional): Light handle for connection to the ATMOS® Strobo 21 LED or LED light module LED light module for permanent light

Control panel

Manual activation / deactivation of light channels

Activation disinfectant times

Display light module Adjustment of brightness resp. disinfectant timer Display of level of brightness resp. of time when switching on the disinfectant timer

• After switching on, the light module is displayed amongst the corresponding light port (LED or no display [no display: no light module integrated / intended]). The kind of display depends on the presetting from installing resp. your purchased options. • The ATMOS® LS 31 LED can be switched on and off independent of the device. Observe the separate operating instructions. • Activate light module by removing the light guide or by taking off the headlight. • In the case that more than one light guide is removed, the last one will be activated. As soon as this light guide is put back, the light source of the other light guide is switched on again. When two light guides are taken out and it should be impeded that the unused channel is activated, it can be switched off manually immediately after removal. • Adjustment of brightness: Choose port, press the up/down button on the right side (possible: from 100 % until 10 %). When switching off the device the last adjustment will be kept. Observe the separate operating instructions for the options: • ATMOS® HL 21 LED • ATMOS® LS 21 LED • ATMOS® LS 31 LED

9

4.0

Operation

4.5 Endoscope management 4.5.1 Overview

Metal quiver (removable) for storage of clean optics, optionally heating Plastics quiver (removable) for storage of used endoscopes and filling with disinfectant dilution Please treat the instruments carefully, when inserting resp. removing.

4.5.2 Endoscope heating

10 - 15 mins

!

41 - 42 °C

Fire hazard! Prior to each use on your patient check your instruments´ temperature (on the back of your hand or similar). Only store and heat clean instruments! Clean and disinfect the storage quivers regularly! Therefore please note the instructions in chapter “5.0 Cleaning”.

4.5.3 Disinfection monitoring

!

Only fill quivers with admitted and nonhazardous disinfectants and always note application advices of the manufacturer. Read more in chapter “5.0 Cleaning”. Please note that the disinfecting quivers can be heated up to max. 42 °C! Additionally please observe the maximal and minimal allowed residence time of instruments in the disinfectant dilution Check the adjusted time prior to use!

10

4.0

Operation

Adjustment of disinfection time When switching on the unit the disinfection time is taken over from prior use.

Disinfection time adjusted

keep pressed

indicator light changes to red

Adjustment of disinfection time

release key press-button

Displayed illuminated segments

1

2

3

4

5

6

7

8

9

10

Time in mins

6

12

18

24

30

36

42

48

54

60

Perform disinfection

No disinfection (green)

Disinfection is executed (red)

Disinfection finished (green)

Stop disinfection Switch off timer by pressing the button again when timer is active! An additional acoustic signal results after end of disinfection.

11

4.0

Operation

4.6 ATMOS® ENT camera – quick start

!

The integrated ATMOS® ENT camera ATMOS® Cam 21 / 31 features separate operating instructions. Please note: Read these separate operating instructions attentively and follow the stated notes for your safety to guarantee ideal and safe use of all functions!

4.6.1 Controls and front view

Buttons for selecting application part and light source

A Connection for camera head B Connection for

LED light source

Mains on/off switch

4.6.2 Operation By switching on the unit ATMOS® S 61 Servant vision the ENT camera is automatically switched on also.

1

2

click

Choose light source 1.) at the treatment unit: Take out the wanted light source. The adjustments on the camera (LED, Halogen) have been set ex works. 2.) directly at the camera: Take out the wanted light source (see above). Choose desired optics by pressing the button at the camera (). Choose the used light source (). When using the camera next time, all adjustments will be taken over from prior use.

1

12

2

4.0

Operation

4.7 ATMOS® LED stroboscope - quick start

!

The integrated ATMOS® LED Stroboscope ATMOS® Strobo 21 LED features separate operating instructions. Please note: Read these separate operating instructions attentively and follow the stated notes for your safety to guarantee ideal and safe use of all functions!

4.7.1 Controls and front view Display Indication for slow motion Indication for freeze image Adjustments

Indication for permanent light

Control knob

A

Connection for microphone

On / Off switch

B

Connection for LED light handle

4.7.2 Operation

1

2

click

click

3 read off measured average values

Phonation

4.7.3 Operate the foot switch



Permanent light





Slow motion





Reflection of individual phases/positions of vocal cord oscillations

 13

5.0

Cleaning and care

5.1 General information on cleaning and disinfection Prior to cleaning Medical devices like the ATMOS® S 61 Servant vision need to be fail safe at any time. Therefore we recommend prior to every use:

if required

5.1.1 Cleaning the unit surface

5.1.2 Instrument trays

• The surfaces of the ATMOS® S 61 Servant vision are resistant against all surface disinfectants listed in chapter „Recommended surface disinfectants“. Please note that long-term use of disinfectants with alcohol might affect the flexibility and transparency of the protective covers. • Wipe the unit surface with a cloth moistened with a cleaning or disinfecting solution. • You may also use disinfectant sprays or disinfectant tissues for cleaning and disinfection. • Please take care that all surfaces are dry wiped. Use a single-use cloth to absorb any liquid. • In case that any disinfectant is spilled, please take care to dry wipe the surface immediately in order that no liquid may penetrate gaps and edges. • Always observe the concentration specifications and instructions by the respective manufacturer! )) Do not use -- Disinfectants which contain organic or inorganic acids or bases as they could cause corrosion damage. -- Disinfectants containing chloramides or phenol derivatives, since these may cause stress cracks in the material used for the housing of the unit.

• Before disinfection, thoroughly rinse the trays under running water. A detergent or cleaning agent (surface disinfectant) may also be used if required. -- Use water to thoroughly rinse all residues of these substances. • Melamine and anodized aluminium trays cannot be sterilised.

• Only deposit clean instruments on the board! • Clean and disinfect the instruments regularly!

14

5.1.3 Endoscope quivers • The metal quivers of the endoscope holder are to be used solely for holding the endoscopes, these first having been cleaned and disinfected. The quivers are to be cleaned daily and subsequently disinfected. For doing this, the stopper at the lower end should be taken off.

5.0

Cleaning and care

5.2 Recommended instrument disinfectants Manual disinfection of instruments Disinfectant Korsolex® med AF (Application concentrate) Korsolex® basic (Application concentrate) Korsolex® plus (Application concentrate) Korsolex® extra (Application concentrate)

neodisher® Septo MED (Application concentrate) neodisher® Septo 3000 (Application concentrate) Sekusept® PLUS (Application concentrate) Sekusept® aktiv (Application concentrate) Gigasept® Instru AF (Application concentrate) Gigasept® FF (new) (Application concentrate) Gigazyme® (Application concentrate)

Ingredients N-dodecylpropane-1,3-diamine N-(3-aminopropyl)-N-dodecylpropane-1,3-diamine surfactants, corrosion inhibitors, ph-value regulators, foam inhibitors glutaral (ethylenedioxy)dimethanol surfactants, salts, corrosion inhibitors N-(3-aminopropyl)-N-dodecylpropane-1,3-diamine didecyldimethylammonium chloride surfactants, corrosion inhibitors, complexing agents, ph-value regulators (ethylendioxy)dimethanol glutaral benzyl-C12-18-alkyldimethyl-ammonium chlorides didecyldimethylammonium chloride surfactants, foam inhibitors, corrosion inhibitors N-(3-aminopropyl)-N-dodecylpropane-1,3-diamine didecyldimethylammonium chloride non-ionic surfactants, perfumes glutaral (ethylenedioxy)dimethanol glucoprotamin sodiumpercarbonate, non-ionic surfactants, phosphonates Cocospropylendiaminguanidindiacetate Phenoxypropanols Benzalkonium chloride non-ionic surfactants, ph-value regulators, corrosion inhibitors succindialdehyde dimethoxytetrahydrofuran anionic and non-ionic surfactants, perfumes, methylisothiazolinone non-ionic surfactants, enzymes, corrosion inhibitors

in 100 g Manufacturer 15.6 g Bode Chemie, 5.1 g Hamburg 15.2 g Bode Chemie, 19.7 g Hamburg 9.2 g Bode Chemie, 13.0 g Hamburg 15.3 g Bode Chemie, 7.5 g Hamburg 1.0 g 1.0 g 9.2 g Dr. Weigert, 13.0 g Hamburg 15.2 g Dr. Weigert, 19.7 g Hamburg 25 g Ecolab, Düsseldorf Ecolab, Düsseldorf 14 g Schülke & Mayr, 35 g Norderstedt 2.5 g 11.9 g Schülke & Mayr, 3.2 g Norderstedt 5 - 15 g Schülke & Mayr, Norderstedt

Automatic disinfection of instruments Disinfectant Dismoclean® 24 Vario (Application concentrate) Dismoclean® 28 alka med (Application concentrate) Dismoclean® twin basic / twin zyme Dismoclean® twin basic Dismoclean® twin zyme neodisher® FA neodisher® MediClean forte (Application concentrate) Thermosept® alka clean forte (Application concentrate) Thermosept® RKN-zym

Ingredients surfactants, micro-encapsulated enzymes, corrosion inhibitors, complexing agents alkali dispenser, complexing agents, corrosion inhibitors, surface active materials

alkali dispenser, complexing agents, corrosion inhibitors surface active materials, enzymes, stabilisers, corrosion inhibitors phosphates non-ionic and anionic surfactants enzymes non-ionic surfactants anionic surfactants NTA (nitrilotriacetic acid) and its salts enzymes, poly carboxylates corrosion inhibitors non-ionic surfactants, enzymes, corrosion inhibitors, glycols

in 100 g Manufacturer Bode Chemie, Hamburg Bode Chemie, Hamburg Bode Chemie, Hamburg

15 - 30 Dr. Weigert, g Hamburg < 5 g Dr. Weigert, Hamburg < 5 g Schülke & Mayr, < 5 g Norderstedt <5g <5g 5 - 15 g Schülke & Mayr, Norderstedt

15

5.0

Cleaning and care

5.3 Recommended surface disinfectants Coated surfaces Disinfectant Green & Clean SK Dismozon® pur (Granulate) End of product 12/2014 Dismozon® plus (Granulate) Kohrsolin® FF (Application concentrate) Perform® Terralin® Protect (Application concentrate)

Ingredients Di alkyl dimethyl ammonium chloride Alkyl dimethyl ethyl benzyl ammonium chloride Alkyl dimethyl benzyl ammonium chloride magnesium monoperoxyphthalate hexahydrate magnesium monoperoxyphthalate hexahydrate glutaral benzyl-C12-18-alkyldimethyl-ammonium chlorides didecyldimethylammonium chloride Potassium peroxymonosulfate benzyl-C12-16 alkyldimethyl, chloride 2-phenoxyethanol aminoalkylglycine non-ionic surfactants, perfumes

in 100 g Manufacturer < 1 g Metasys, Rum < 1 g (Austria) <1g 80 g Bode Chemie, Hamburg 95.8 g Bode Chemie, Hamburg 5 g Bode Chemie, 3 g Hamburg 3g 45 g Schülke & Mayr, Norderstedt 22 g Schülke & Mayr, 17 g Norderstedt 0.9 g

Other surfaces Disinfectant Dismozon® pur (Granulate) End of product 12/2014

Ingredients magnesium monoperoxyphthalate hexahydrate

magnesium monoperoxyphthalate hexahydrate Dismozon® plus (Granulate) glutaral Kohrsolin® FF (Application concentrate) benzyl-C12-18-alkyldimethyl-ammonium chlorides didecyldimethylammonium chloride Potassium peroxymonosulfate Perform® benzyl-C12-16 alkyldimethyl, chloride Terralin® Protect (Application concentrate) 2-phenoxyethanol aminoalkylglycine non-ionic surfactants, perfumes Surface disinfection F alkyl-benzyl-dimethyl-ammonium chloride 312 non-ionic surfactants, complexing agents, hexyl cinnamal, butyl phenyl methyl proionale, linalool

in 100 g Manufacturer 80 g Bode Chemie, Hamburg 95.8 g Bode Chemie, Hamburg 5 g Bode Chemie, 3 g Hamburg 3g 45 g Schülke & Mayr, Norderstedt 22 g Schülke & Mayr, 17 g Norderstedt 0.9 g 13 g Dürr Dental, BietigheimBissingen

When using disinfectants containing aldehyde and amine at the same object. colour changes may occur.

16

5.0

Cleaning and care

5.4 Recommended endoscope disinfectants Manual disinfection of endoscopes Disinfectant Helipur® H plus N

Helix® Ultra

Ingredients glutaral 2-propanol ethyl hexanol surfactants, complexing agents, corrosion inhibitors, colorants, perfumes peracetic acid

Korsolex® basic

glutaral (ethylendioxy) dimethanol surfactants, salts, corrosion inhibitors neodisher® MediClean forte non-ionic and anionic surfactants (Application concentrate) enzymes sodiumpercarbonate, non-ionic surfactants, phosphonates Sekusept® aktiv (Application concentrate)

in 100 g Manufacturer 12 g BBraun, 7.5 g Melsungen 0.5 g BBraun, Melsungen 15.2 g Bode Chemie, 19.7 g Hamburg < 5 g Dr. Weigert, Hamburg Ecolab, Düsseldorf

Automatic disinfection of endoscopes Disinfectant Korsolex® basic neodisher® MediClean forte (Application concentrate) Gigasept® FF (new) (Application concentrate)

Ingredients glutaral (ethylendioxy) dimethanol surfactants, salts, corrosion inhibitors non-ionic and anionic surfactants enzymes

Endozime® AW Plus

succindialdehyde dimethoxytetrahydrofuran anionic and non-ionic surfactants, perfumes, methylisothiazolinone 2-propanol

AdaptacleanTM

Potassium hydroxide, surfactants

in 100 g Manufacturer 15.2 g Bode Chemie, 19.7 g Hamburg < 5 g Dr. Weigert, Hamburg 11.9 g Schülke 3.2 g & Mayr, Norderstedt Ruhof, Mineola (USA) ASP, Norderstedt

17

Cleaning and disinfection plan ATMOS® S 61 Servant Notices

S

Who Monthly

D

Disinfection Sterilization

Weekly

C

Cleaning

When

Daily

Parts to be reprocessed

How After each application

What

Secretion canister Hose connection (grommet)

X

X2,4,5

Cleaning and disinfection (manual or automatic)

X

Secretion canister lid

X

X

2,4,5

Cleaning and disinfection (manual or automatic)

X

Seal

X

X2,4,5

Cleaning and disinfection (manual or automatic)

X

Exchange daily or when blocked

X

Splash guard

X

X2,4,5

Cleaning and disinfection (manual or automatic)

X

Float ball

X

X

Cleaning and disinfection (manual or automatic)

X

Suction hose in the canister

X

X

Cleaning and disinfection (manual or automatic)

X

Secretion canister

X

X

Empty when the canister is full; at least daily; Cleaning and disinfection (manual or automatic)

X

Exchange and disposal of full canister

X

Bacterial filter

2,4,5

Disposable canister system

Hose rinsing system Suction nozzle for hose rinsing Silicone attachment piece

Suction nipple

Secretion suction hose Storage canister hose rinsing

X

X3

Wipe cleaning and disinfection

X

X

X2,4,5.6

Cleaning and disinfection (manual or automatic)

X

Exchange of the silicone attachment Manual cleaning after each application

X X2,4,5.6

X

Cleaning and disinfection (manual or automatic) Rinse the secretion hose with the hose rinsing system after each application;

X

X X

X2,4,5.6

Exchange or disinfection of the hose

X2,4,5.6

Cleaning with a brush; cleaning and disinfection (automatic or manual)

X X X X

Ear irrigation / Thermal nystagmus stimulation Ear irrigation bowl

X

X2,4,5

Cleaning and disinfection (manual or automatic)

Handle

X

X3

Wipe cleaning and disinfection

X

Jet connection

X

X2,4,5.6

Cleaning and disinfection (manual or automatic)

X

Splash guard

X

X

Cleaning and disinfection (manual or automatic)

2,4,5

Hose tip (disposable) Rinsing attachment

X

X2,4,5

Hygiene filter

X

X

Exchange after each application

X

Cleaning and disinfection (manual or automatic)

X

See operating instructions for hygiene filter

X

Rinsing lid with rinsing hose

X

X2,4,5

Cleaning and disinfection (manual or automatic)

X

Rinsing bottle

X

X2,4,5.6

Cleaning and disinfection (manual or automatic); cleaning in the dishwasher with the glass care programme

X

Medication nebulisation / Politzer Handle compressed air Sprayer jet

X

X3

Sprayer head

Manual cleaning and disinfection Cleaning after each application

X X2,4,5.6

Cleaning and disinfection (manual or automatic)

X2,4,5

Multiple rinsing of the sprayer head with water

Hose at sprayer head

X

X

Sprayer bottle

X

X

2,4,5.6

Politzer olive

X

X

2,4,5.6

Politzer connection

X

X

2,4,5.6

Weekly exchange of the hose or when changing the medication Cleaning in a cleaning and disinfection device; weekly or when changing the medication Exchange after each application, cleaning and disinfection Exchange after each application, cleaning and disinfection

X X X X X X X X

Endoscope management Plastic quiver

X

X2,4,5

Cleaning with a brush; disinfection

X

Metal quiver

X

X

Cleaning with a brush; disinfection (automatic or manual)

X

X

X2,4,5

Cleaning and disinfection (manual or automatic)

X

X

X2,4,5

Cleaning and disinfection (manual or automatic)

X

Fixation adapter for plastic quiver Protective sleeve (teflon element for metal quiver)

2,4,5.6

Qualified and trained staff who are familiar with reprocessing. (Please fill in the responsible person -> use a water-based overhead marker)

S

Disinfection Sterilization

Who Monthly

D

Notices

Weekly

C

Cleaning

When

Daily

Parts to be reprocessed

How After each application

What

Qualified and trained staff who are familiar with reprocessing. (Please fill in the responsible person, use a water-based overhead marker)

Instrument management Immerse instruments into solution immediately after use, complete wetting is required, air must be removed from any cavities, after the contact time instruments must be rinsed with water, have to be dried and sterilised afterwards. Please also observe the ATMOS operating instructions for ENT instruments.

ENT instruments

X

X2,4,5

Instrument bowl

X

X4

Cleaning and disinfection (manual)

X

Instrument bowl with cover

X

X4

Cleaning with a brush; disinfection (manual)

X

ATMOS® Cam 21 / 31

X

X3

Wipe cleaning and disinfection

X

ATMOS Strobo 21 LED

X

X3

Wipe cleaning and disinfection

X

ATMOS® LS 31 LED

X

X3

Wipe cleaning and disinfection

Flexible Endoscope

X

X1,7,8

X1

Immediate pre-cleaning after application

X

Rigid endoscope

X

X1,7,8

X1

Immediate pre-cleaning after application

X

Laryngoscope

X

X

X

Immediate pre-cleaning after application

X

Light cable

X

X3

Wipe cleaning and disinfection

X

Light grip

X

X3

Wipe cleaning and disinfection

X

Microscope

X

X3

Wipe cleaning and disinfection

X

Headlight

X

X3

Wipe cleaning and disinfection

X

X

X

Visualization ®

1,7,8

1

X

Radiofrequency surgery ATMOS® RS 221 (surface)

X

X3

Ergonomic handles

X

X1,2,4.5

X1

Wipe cleaning and disinfection Wipe cleaning and disinfection

X

Bipolar tweezers

X

X1,2,4.5

X1

Bipolar electrode

X1,2,4.5

X1

Immediate pre-cleaning after application; Cleaning and disinfection (manual or automatic); Use of enzymatic detergents

X

X

Bipolar electrode cable

X

X

1,2,4.5

X

X

Neutral electrode

X

X1,2,4.5

X1

Immediate pre-cleaning after application; Cleaning and disinfection (manual or automatic); Use of enzymatic detergents

Neutral electrode cable

X

X1,2,4.5

X1

X

ENT electrodes

X

X1,2,4.5

X1

Immediate pre-cleaning after application; Cleaning and disinfection (manual or automatic); Use of enzymatic detergents

Housing

X

X3

Wipe cleaning and disinfection

X

Roller shutter

X

X3

Wipe cleaning and disinfection

X

System frame

X

X3

Wipe cleaning and disinfection

X

Drawers

X

X3

Wipe cleaning and disinfection

Writing surface

X

X3

Wipe cleaning and disinfection

X

Instrument deposit

X

X3

Wipe cleaning and disinfection

X

Mirror preheater

X

X3

Wipe cleaning and disinfection

Tongue patches and swab dispenser

X

X3

Waste disposal

X

X3

Instrument tray

X

X3

1

X

X

X

X

Surfaces

Recommended disinfectants Surface disinfection for coated surfaces: • Green & Clean SK (ATMOS) • Dismozon® plus (Bode Chemie) • Kohrsolin® FF (Bode Chemie) • Perform® (Schülke & Mayr) • Terralin® Protect (Schülke & Mayr) 3)

Other surfaces: • Dismozon® plus (Bode Chemie) • Kohrsolin® FF (Bode Chemie) • Mikrobac® forte (Bode Chemie) • Perform® (Schülke & Mayr) • Terralin® Protect (Schülke & Mayr) • Surface disinfectant FD 312 (Dürr Dental)

Important information Wipe cleaning and disinfection: All surfaces have to be wiped with a clean (disposable) wipe which is damped with disinfectant solution. The entire surface has to be wiped thoroughly and may not be dried afterwards.

4)

• • • • • • • • • • • 5)

• • • • • • •

Wipe cleaning and disinfection; Daily or when refilling Wipe cleaning and disinfection; Daily or when refilling Wipe cleaning and disinfection; Daily or when refilling

Manual disinfection of instruments: Korsolex® med AF (Bode Chemie) Korsolex® basic (Bode Chemie) Korsolex® plus (Bode Chemie) Korsolex® extra (Bode Chemie) neodisher® Septo MED (Dr. Weigert) neodisher® Septo 3000 (Dr. Weigert) Sekusept® PLUS (Ecolab) Sekusept® aktiv (Ecolab) Gigasept® Instru AF (Schülke & Mayr) Gigazyme® (Schülke & Mayr) Gigasept FF neu (Schülke & Mayr) Automatic disinfection of instruments: Dismoclean® 24 Vario (Bode Chemie) Dismoclean® 28 alka med (Bode Chemie) Dismoclean® twin basic/twin zyme (Bode Chemie) neodisher® FA (Dr. Weigert) neodisher® MediClean forte (Dr. Weigert) Thermosept® alka clean forte (Schülke & Mayr) Thermosept® RKN-zym (Schülke & Mayr)

Please observe the manufacturer‘s operating instructions. Preferred: machine cleaning and disinfection in the washer disinfector 6) Material dimensionally stable at 134°C 1)

2)

7)

     8)

    

Endoscopes - manual disinfection: Helipur® H plus N (BBraun) Helix® Ultra (BBraun) Korsolex® Basic (Bode Chemie) neodisher® MediClean forte (Dr. Weigert) Sekusept® aktiv (Ecolab) Endoscopes - automatic disinfection: Korsolex® Basic (Bode Chemie) neodisher® MediClean forte (Dr. Weigert) Gigasept® FF neu (Schülke & Mayr) Endozime® AW Plus (Ruhof) ADAPTACLEAN™ (ASP)

For concentrations, contact time, temperature, material compatibility, please see the relevant information from the manufacturer.

Wrong concentration of disinfectants may lead to material damage!

X

X X X X

The above stated hygiene requirements are based on the regulations according to the Medical Devices Act, the Medical Devices Operator Ordinance, §18 IfSG and the recommendations of the Robert Koch Institute. Definition of the required reprocessing steps result from the recommendations of the Robert Koch Institute: „Requirements for the reprocessing of medical products“, from Robert Koch Institute. The medical products were categorised in the risk groups uncritical, semi-critical and critical. The reprocessing measures mentioned in this cleaning and disinfection plan are a recommendation of ATMOS MedizinTechnik. Any additional reprocessing measures are at the operator‘s discretion. All the recommended disinfectants which are stated herein are listed disinfectants (VAH/RKI) and have been tested on their suitability of use on the ATMOS® S 61 Servant. ATMOS MedizinTechnik cannot be hold liable for any damage caused by wrong concentration of the disinfectants or by the application of any other disinfectants. Patients with suspicion of a clinical disease or who developed a transmissible spongiform encephalopathy (CJK, vCJK, etc.) have to be treated at facilities which are able to provide for the necessary preventive measures against infection. The reprocessing of the reusable instruments and material may only be performed at facilities which have an externally certified QM Management acc. to DIN EN ISO 13485. The Medical Devices Act, IfSG, the RKI directives, BGR 250 and TRBA 250 always have to be considered.

ATMOS MedizinTechnik GmbH & Co. KG Ludwig-Kegel-Str. 16  79853 Lenzkirch/Germany Phone +49 7653 689-0  Fax +49 7653 689-190 [email protected]  www.atmosmed.de

GA3GB.110100.0

2017-12 Index: 14

7.0

Maintenance and Service

Maintenance, 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. At least every 12 months a repeat test of the electrical safety should be performed according to IEC 62353. ATMOS recommends an inspection according to the manufacturer‘s specifications.

7.1 Replacing the fuse 7.1.1 Earthing contact socket outlet

7.1.2 Fixed connection

7.2 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 to 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.

20