ATMOS S 61 Servant instruments Operating Instructions Index 25 March 2018

Table of contents 1.0 1.1 1.2 1.3

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

2.0

For your safety...5

3.0 3.1 3.2

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

4.0

Operation...8

5.0 5.1 5.1.1 5.1.2 5.2 5.3 5.4

Cleaning and care...9 General information on cleaning and disinfection..9 Cleaning the unit surface...9 Instrument trays...9 Recommended instrument disinfectants...10 Recommended surface disinfectants...11 Recommended endoscope disinfectants...12

6.0

Hygiene plan...13

7.0 7.1 7.2 7.3

Maintenance and Service...15 Replacing the fuse ATMOS® S 61 Servant instruments...15 Replacing the fuse heated drawer...15 Sending in the device...15

8.0

Technical data...15

9.0

Disposal...16

10.0

Notes on EMC...17

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

ATMOS

MedizinTechnik GmbH & Co. KG Ludwig-Kegel-Straße 16 79853 Lenzkirch Germany Phone: +49 76 53 / 689-0 Fax: +49 76 53 / 689-190 +49 76 53 / 689-493 (Service Centre) [email protected] www.atmosmed.de

2

1.0

Introduction

1.1 Notes on Operating Instructions These operating instructions contain important notes on how to operate the ATMOS® S 61 Servant instruments 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 instruments 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 instruments will be preserved.

• The product ATMOS® S 61 Servant instruments 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 instruments 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 Intended use Name: ATMOS® S 61 Servant instruments Main functions: ATMOS® S 61 Servant instruments: • Instrument management Medical indications / application: Standard ENT examination and/or therapy Specification of the main function: ATMOS® S 61 Servant instruments: • Instrument deposit and heating • Storage room for examination and therapy devices 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 and disinfection, please see the operating instructions.

3

1.0

Introduction

1.3 Explanation of pictures and symbols

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

■

General information

Move, plug... in this direction

Please press where dot indicates

●

Numeration

Turn, shift ... in this direction

Activate the optional foot switch

→

Subnumeration Check

Please read, important information

click

Icons on the product

!

Warning, special diligent notice

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

Ground wire connection

~

Alternating current On (feed-in, power connection) Off (feed-in, power connection)

4

Replace Engage, check correct fit

2.0

For your safety

!

For your safety

• The ATMOS® S 61 Servant instruments 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 device may only be connected to a properly installed grounded electrical outlet. Correct configuration in assembly of country-specific connections: green/yellow: non-fused earth conductor (PE) blue: neutral conductor (N) black resp. brown: phase (L) • Caution! Mirror and endoscope heaters may generate temperatures above 40°C! • The ATMOS® S 61 Servant instruments 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 indicated on the type plate must correspond to the values of the supply network. • Make sure prior to every application of the equipment that it is technically safe and in proper condition. Damaged leads and hoses must be replaced immediately! • It is prohibited to simultaneously pull out several heavily laden instrument deposits. • Never leave the patient unattended at the treatment unit.

• 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 except on destined places! • The ambient conditions specified in the "Technical data" must be strictly observed! • Switch off main switches of the installed devices after finishing work in the practice. • The ATMOS® S 61 Servant instruments 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 instruments 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 instruments 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. • In order to fully disconnect the device from the mains supply the mains plug must be removed from the wall outlet. • This product is not re-sterilizable. Repeated reuse of components which are marked with a 2 is forbidden. In case of repeated reuse these components lose their function and there is a high infection risk.

5

>350

Connecting conditions

<150

ca. 250

3.0

160

250

1730

445

740

640 1550

630 730 1961

979,5 2940

6

3.0

Connecting conditions

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 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 instruments to a safety socket outlet near the device, max. 3 meters, preferably left (fig.). • 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: 2.300 VA -- ATMOS® S 61 Servant workstation 200 VA -- ATMOS® S 61 Servant vision 250 VA -- ATMOS® S 61 Servant instruments 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.

i First start-up

Prior to shipment each ATMOS® S 61 Servant instruments 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.

i Connect the unit to a mains socket with the supplied IEC power connector. Please observe country-specific voltage!

The ATMOS® S 61 Servant instruments has no mains switch for switching on the devices. Each optional available electrical device has its own mains switch. For separation from the power supply please disconnect the power plug!

7

4.0

8

Operation Roller-shutter cover with lock

Heated drawer For switching on/off the heating, please pull out the drawer fully and operate the on/off switch in the rear of the drawer.

Mirror pre-heating The heated mirror magazine has space for approx. 70 mirrors (size K2 to K7). In order to prevent the mirrors from fogging, the magazine is pre-heated to body temperature (38°C). Switch on the mirror pre-heater at the separate lateral power switch.

Deposit for used instruments To be filled / emptied

Retractable writing surface When pulling out the writing surface, please note that it has a stop position.

Waste bin Tip with your foot to open. Insert a waste bag.

Insertable shelf for keyboard For safe storage of a wireless PC keyboard.

Drawer without cover Height x width: 134 mm x 283 mm E.g. for ATMOS® RS 221 Radiofrequency surgery. Observe the notes in the operating instructions which are delivered separately.

5.0

Cleaning and care

5.1 General information on cleaning and disinfection Prior to cleaning Set main switch of the ATMOS® S 61 Servant instruments to OFF prior to cleaning and disinfection! Prior to each use:

if required

)) The described action relating to cleaning and disinfection resp. sterilisation do not substitute the relevant instructions which must be adhered to prior to operation! • For disinfection, you may use all surface and instrument disinfectants listed on page 10. • 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.

5.1.1 Cleaning the unit surface

5.1.2 Instrument trays

• The surfaces of the ATMOS® S 61 Servant instruments are resistant against all surface disinfectants listed in on page 11. • 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. ªª Please note that the alcohol contained in these agents could corrode or cloud the protective covers if employed on a long term basis.

• 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!

9

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

10

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

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 Pentapotassium-bis(peroxymonosulphate)-bis(sulphate) 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 benzyl-C12-18-alkyldimethyl-ammonium chlorides Mikrobac® forte (Application concentrate) N-(3-aminopropyl)-N-dodecylpropane-1,3-diamine Pentapotassium-bis(peroxymonosulphate)-bis(sulphate) 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 19.9 g Bode Chemie, 5 g Hamburg 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.

11

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

Ingredients glutaral (ethylendioxy) dimethanol surfactants, salts, corrosion inhibitors neodisher® MediClean forte non-ionic and anionic surfactants (Application concentrate) enzymes ® succindialdehyde Gigasept FF (new) (Application concentrate) dimethoxytetrahydrofuran anionic and non-ionic surfactants, perfumes, methylisothiazolinone 2-propanol Endozime® AW Plus AdaptacleanTM

12

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

6.0

Hygiene Plan Cleaning and disinfection plan ATMOS® S 61 Servant

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)

Secretion canister Hose connection (grommet)

X

X2,4,5

Cleaning and disinfection (manual or automatic)

X

Secretion canister lid

X

X2,4,5

Cleaning and disinfection (manual or automatic)

X

Seal

X

X

Cleaning and disinfection (manual or automatic)

X

Exchange daily or when blocked

X

2,4,5

Bacterial filter Splash guard

X

X

Cleaning and disinfection (manual or automatic)

X

Float ball

X

X

Cleaning and disinfection (manual or automatic)

X

Suction hose in the canister

X

X2,4,5

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

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 X2,4,5.6

Exchange or disinfection of the hose

X

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

2,4,5.6

X X 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

X2,4,5

Cleaning and disinfection (manual or automatic)

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

Politzer olive

X

X2,4,5.6

Politzer connection

X

X2,4,5.6

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

X2,4,5.6

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)

13

Hygiene Plan

D

Notices

S

Disinfection Sterilization

Who Monthly

C

Cleaning

When Weekly

Parts to be reprocessed

How

Daily

What

After each application

6.0

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

X

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

X1,7,8

X1

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

2,4,5

X

X

Visualization

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

X

X1,2,4.5

X1

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

X

Bipolar electrode Bipolar electrode cable

X

X1,2,4.5

X1

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

X

Waste disposal

X

X3

Instrument tray

X

X3

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.

14

4)

• • • • • • • • • • • 5)

• • • • • • •

3

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 ATMOS® S 61 Servant instruments

7.2 Replacing the fuse heated drawer Remove the fuse carrier beside the On/Off switch and exchange the fuse.

7.3 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.

8.0

Technical data

Voltage

230 V~ ± 10 %; 50/60 Hz Special voltage: 100-127 V~ ± 10 %; 50/60 Hz Relevant for single modules

Current consumption

Max. 1.1 A (230 V~); max. 2.2 A (100 V~)

Power consumption

Max. 250 W

Fuses

2 x T 3.15 A (250 V)

Other safety equipment

Heating elements by design max. 60°C

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8.0

Technical data

Mirror preheater • Temperature of Instruments

Approx. 37 °C

• Heating performance

Max. 50 VA

Heated drawer • Temperature of Instruments

Approx. 37 °C

• Heating performance

Max. 230 VA

Operating time

Continuous operation

Protective earth conductor resistance

Max. 0,1 Ω

Earth leakage current

Max. 0.5 mA

Housing leakage current

Max. 0.1 mA

Patient leakage current

Max. 0.1 mA

Ambient conditions for transport/storage • Temperature

-10...+50°C

• Air humidity

30...95 % without condensation

• Air pressure

500...1060 hPa

Ambient conditions operation • Temperature

+10...+35°C

• Air humidity

30...95 % without condensation

• Air pressure

700...1060 hPa

Maximum operational altitude

≤ 3000 m

Contamination level

Class 2

Overvoltage category

II

Dimensions HxWxD

88.5 x 41.2 x 54.0 cm

Weight

15-32 kg

Period tests

Repeat test of the electrical safety every 12 months. Recommended: inspection according to the manufacturer‘s specifications.

Safety class (EN 60601-1)

I

Degree of protection

No application parts

Type of protection

IP X0

Classification in accordance with Appendix IX EC Directive 93/42/EEC

Class 1

CE marking

CE

GMDN code

11585

UMDNS code

10-585 ENT treatment unit

ID No. (REF)

532.0000.0 Basic module 532.0110.0 power supply module 230 V 532.0111.0 power supply module 100 - 127 V

9.0

Disposal

• The materials of the housing can be recycled completely. • The ATMOS® S 61 Servant instruments does not contain any hazardous goods. • The component parts of the ATMOS® S 61 Servant instruments must be disposed of correctly and the materials are to be separated carefully.

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10.0 Notes on EMC electrical equipment is subject to special precautions with regard to EMC and must be installed acc. to following EMC i • Medical notes. • Portable and mobile HF communication facilities can influence medical electrical equipment. • The use of other accessories, other converters and cables than stated may lead to an increased emission or a reduced interference immunity of the equipment or system.

10.1 Guidelines and Manufacturer´s Declaration - Emissions The ATMOS® S 61 Servant instruments is intended for use in the electromagnetic environment specified below. The customer or user of the ATMOS® S 61 Servant instruments should ensure that it is used in such an environment. Emissions Test

Compliance

Electromagnetic Environment - Guidance

RF Emissions acc.to CISPR 11

Group 1

The ATMOS® S 61 Servant instruments uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

RF Emissions according to CISPR 11

Class B

Harmonic emissions according to IEC 61000-3-2

Inapplicable

Voltage fluctuations/flicker according Inapplicable to IEC 61000-3-3

The ATMOS® S 61 Servant instruments is suitable for use in all establishments, including domestic, and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

device may not be used directly next to other devices or piled up with other devices. If operation next to or piled with other i The devices is necessary, please watch the device to check its intended operation in this arrangement.

10.2 Guidelines and Manufacturer's Declaration - Immunity The ATMOS® S 61 Servant instruments is intended for use in the electromagnetic environment specified below. The customer or user of the ATMOS® S 61 Servant instruments should ensure that it is used in such an environment.

Immunity Test

IEC 60601- Test Level

Compliance Level

Electromagnetic Environment - Guidance

Electrostatic discharge (ESD) according to IEC 61000-4-2

± 6 kV Contact ± 8 kV Air

± 6 kV Contact ± 8 kV Air

Floors should be wood, concrete, or ceramic tile. If floors are synthetic, the relative humidity should be at least 30 %.

Fast electrical transient/ burst IEC 61000-4-4

± 2 kV Mains ± 1 kV I/Os

± 2 kV Mains Inapplicable

Mains power quality should be that of a typical commercial or hospital environment.

Surges IEC 61000-4-5

± 1 kV differential mode ± 1 kV common-mode

± 2 kV differential mode ± 1 kV common-mode

Mains power quality should be that of a typical commercial or hospital environment.

Magnetic field at power frequency 50/60 Hz acc. to IEC 61000-4-8

3 A/m

Inapplicable

Power frequency magnetic fields should be that of a typical commercial or hospital environment.

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10.0 Notes on EMC Immunity Test

IEC 60601- Test Level

Voltage Dips / Dropout < 5 % UT (> 95 % Dip of the UT) IEC 61000-4-11 for 0,5 Cycles 40 % UT 60% Dip of the UT) for 5 Cycles 70% UT (30 % Dip of the UT) for 25 Cycles < 5 % UT (>95 % Dip of the UT) for 5 s

Compliance Level

Electromagnetic Environment - Guidance

< 5 % UT (> 95 % Dip of the UT) for 0,5 Cycles 40 % UT 60% Dip of the UT) for 5 Cycles 70% UT (30 % Dip of the UT) for 25 Cycles < 5 % UT (>95 % Dip of the UT) for 5 s

Mains power quality should be that of a typical commercial or hospital environment. If the user of the ATMOS® S 61 Servant instruments demands continued function even in case of interruptions of the energy supply, it is recommended to supply the ATMOS® S 61 Servant instruments from an uninterruptible current supply or a battery.

NOTE UT is the mains alternating current prior to application of the test levels.

10.3 Guidelines and Manufacturer´s Declaration - Immunity The ATMOS® S 61 Servant instruments is intended for use in the electromagnetic environment specified below. The customer or user of the ATMOS® S 61 Servant instruments should ensure that it is used in such an environment.

Immunity Test

IEC 60601- Test Level

Compliance Level

Conducted RF IEC 61000-4-6

3 Veff 150 kHz to 80 MHz

3 Veff

Radiated RF IEC 61000-4-3

3 V/m 80 MHz to 2.5 GHz

3 V/m

Electromagnetic Environment - Guidance Portable and mobile communications equipment should be separated from the ATMOS® S 61 Servant instruments incl. the cables by no less than the distances calculated/listed below. Recommended distances: d = (3.5 / V1) * √(P) d = (3.5 / E1) * √(P) 80-800 MHz d = (7 / E1) * √(P) 0.8-2.5 GHz where „P“ is the max. power in watts (W) and d is the recommended separation distance in meters (m). Field strengths from fixed transmitters, as determined by an electromagnetic site (a) survey, should be less than the compliance level (b). Interference may occur in the vicinity of equipment containing following symbol:

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10.0 Notes on EMC NOTE 1 By 80 MHz and 800 MHz the higher frequency range applies. NOTE 2 These guidelines may not be applicable in all cases. The emanation of electromagnetic waves is affected by absorption and reflection of buildings, objects and people. a The field strength of stationary transmitters, such as base stations of cellular phones and mobile terrain radio equipment, amateur radio transmitters, cbm broadcast and TV stations cannot be predestined exactly. To determine the electromagnetic environment in regard to stationary transmitters, a study of the location is to be considered. If the measured field strength at the location where the ATMOS® S 61 Servant instruments is used exceeds the above compliance level, the ATMOS® S 61 Servant instruments is to be observed to verify the intended use. If abnormal performance characteristics are noted, additional measures might be necessary, e. g. a changed arrangement or another location for the device. b Within the frequency range of 150 kHz to 80 MHz the field strength should be below 3 V/m.

10.4 Recommended safety distance between portable and mobile RF Communications equipment and the ATMOS® S 61 Servant instruments The ATMOS® S 61 Servant instruments is intended for use in electromagnetic environment in which radiated disturbances are controlled. The customer or user of the ATMOS® S 61 Servant instruments can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF Communications equipment and the ATMOS® S 61 Servant instruments as recommended below, according to the maximum output power of the communications equipment.

Safety distance, depending on transmit-frequency m Nominal output of the transmitter

150 kHz to 80 MHz d = [ 3.5 / 3] √P

80 MHz to 800 MHz d = [ 3.5 / 3] √P

800 MHz to 2.5 GHz d = [ 7.0 / 3] √P

W 0.01

0.12

0.12

0.24

0.1

0.37

0.37

0.74

1

1.2

1.2

2.4

10

3.69

3.69

7.38

100

11.66

11.66

23.32

For transmitters for which the maximum nominal output is not indicated in the above table, the recommended safety distance d in meters (m) can be determined using the equation belonging to the respective column whereas P is the maximum nominal output of the transmitter in watts (W) acc. to manufacturer´s specification. NOTE 1 By 80 MHz and 800 MHz the higher frequency range applies. NOTE 2 These guidelines may not be applicable in all cases. The emanation of electromagnetic waves is affected by absorption and reflection of buildings, objects and people.

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