ATMOS S 61 Servant vision Operating Instructions Index 20 Aug 2014

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

ATMOS

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

Contents 1.0

Introduction... 5

2.0

For your safety... 7

3.0

Assembly: Connecting conditions... 8

1.1 Notes on operating instructions 1.2 Intended use 1.3 Function 1.4 Explanation of symbols

3.1 Required connections 3.2 Connection to electrical power line

4.0

8 8

Operation... 9

4.1 Controls and options 4.2 Connections 4.3 On / off switch 4.4 Light modules and controls 4.5 Endoscope management 4.6 ATMOS ENT camera 4.7 ATMOS LED stroboscope

5.0

5 5 5 6

9 9 10 11 12 14 15

Cleaning... 16

5.1 General notes on cleaning 5.2 Recommended instruments disinfectants 5.3 Recommended surface disinfectants

16 17 17

6.0

Hygiene plan...18-19

7.0

Maintenance and servicing... 20

7.1 Replacement of fuse 7.2 Replacement of bulbs

20 20

8.0

Trouble shooting... 21

9.0

Accessories... 22

10.0 Technical specifications... 23 11.0 Disposal... 24 12.0 Notes on EMC... 25

3

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. Therefore, they are intended not only for new operating personnel to be instructed in its use, but also for use as a reference manual. They help to avoid risks, and also to reduce repair costs and down-time. Furthermore, reliability and service-life of the equipment will be increased. For these reasons these operating instructions must always be kept available near the appliance. Prior to first use please peruse the chapter 2.0 “For your safety”, in order to be prepared for any possible dangerous situation. Care and safety inspections in conjunction with professional execution provide for operational safety and readiness for use of your ATMOS S 61 Servant vision and are therefore a must besides regular cleaning. Repair work and safety inspections 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 according to the EC Directive of the council for medical products 93/42/EEC and meets the basic requirements of annex I of this 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 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 9001 and 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

Zweckbestimmung

Name: ATMOS® S 61 Servant vision Main functions: • Light sources • Storage and heating of endoscopes • Visualization • Stroboscopy for larynx diagnostic Med. indications/ application: Standard ENT examination and/or therapy Specification of the main function: • Light source 15 V, 150 W • Light source 24 V, 150 W • LED light source, 700 mA • camera (ATMOS Cam) • stroboscope (ATMOS Strobo 21 LED) Application organ: Mouth to pharynx, auditory canal to the ear drum and the nasal cavities. Application time: • ENT unit: Short term use on the patient (up to 30 days) • Suction / Compressed air / ear rinsing / light source: Temporary application on the patient (less than 60 minutes)

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:

X active

□ not active

Sterility: The ENT unit is no sterile product. Single use product / reprocessing: The ENT workstation is designed for multiple use. The device and part of the accessories are reusable, for information on reprocessing and disinfection please see the operating instructions.

1.3

Function

• Coldlight channels (halogen, 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

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.

5

...1.0 Introduction 1.4 Explanation of pictures and symbols Short cuts / symbols contained in this manual Follow the arrows whilst proceeding, sequence

■

General information

Move, plug ... in this direction

Please press where the dot indicates

●

Numeration

Turn, shift ... in this direction

Activate the optional foot switch

→

Subnumeration

Please read, important information

Check

click

Pictures contained in this manual

!

6

Warning, especial diligent notice

Replace Engage, check correct fit

IEEE 1394 Digital Interface Ground wire connection

Signal input

~

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

Signal output

Application part type BF

Signal in- and output

On (feed-in, power connection)

Potential equalization

Foot switch

Off (feed-in, power connection)

Alternating current

2.0

For your safety

!

Important notes on safety

 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!

 Display instruments and valves must be checked for correct function in regular intevals!

 Correct configuration in assembly of country-specific connections: green/yellow: blue: black resp. brown:

protective conductor (PE) neutral conductor (N) phase (L)

 Please note:  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).

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 corre spond o the power consumption of all the devices to be connected.

 The unit may be connected only to a fixed connection installed according to the rules of the trade.

 The unit should not be positioned directly next to a wall, because of the ventilation openings on the rear side !

 Attention! 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 fi eld of light emission of the light guide resp. 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 heat-absorbing 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. Harmful heat rays are eliminated by special built-in filters: but 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.

 The ATMOS S 61 Servant vision may be used in super-

vised operation by qualified personnel only which has been authorised by ATMOS and which has been trained for operating the appliance (IEC 601-1/EN 60601-1).

 The mains voltage specified on the type plate must

correspond with the data of the power supply system.

 ATMOS recommends a safety-related inspection to be performed once a year by an authorised specialist.

 Never leave the patient unattended at the treatment unit.

 Do not place used contaminated instruments on the ENT unit!

 The ambient conditions specified in section „Technical specifications“ must be strictly observed!

 Switch off main switch after finishing work in practice.  The ATMOS S 61 Servant vision may be operated only in

rooms used for medical purposes, but not in areas subject to explosion hazard and in oxygen rich environments..

 The ATMOS S 61 Servant vision fully complies with the

electromagnetic immunity requirements of standard IEC 601-1-2 / EN 60601-1-2 „Electromagnetic compatibility - Medical Electrical Equipment“.

 The ATMOS S 61 Servant vision may not be operated with

units not complying with the requirements of standard EN 60601-1 „Medical Electrical Equipment“ and EN 606011-2 „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.

 These operation instructions corresponds with the con-

struction of the unit and with the current status of safetyrelated standards at the time of printing. Proprietary rights are existing for all described circuits, processes, names, software programs and units.

 Never touch the interface of the device and the patient at the same time!

 The unit may only be opened by a specialist authorised

by ATMOS! Switch off the main switch of the device and disconnect it from the mains supply prior to opening.

7

3.0

Assembly: Connecting conditions

250

1730

445

<150

ca. 250

>350

740

640

160 1550

630 730 1961

979,5 2940

3.1

Required connections for all units of ATMOS S 61 Servant Unit / Device

Maximum required connections

ATMOS S 61 Servant ENT workstation

1x earthing contact socket outlet

ATMOS S 61 Servant vision

1x fixed connection

ATMOS S 61 Servant instruments

1x earthing contact socket outlet

ATMOS S 61 Servant therapy

2x earthing contact socket outlet

Water separating system (WTA)

1x earthing contact socket outlet

Monitor

1x earthing contact socket outlet

Patient chair

1x earthing contact socket outlet

!

The fixed connection of the ATMOS S 61 Servant vision has to be connected to a separate electric circuit!

3.2 Connection to electrical power line  According to the directions of VDE 0107 and VDE 0100, medically used rooms have to be equipped with a leakage current protective circuit (FI protective circuit) with a nominal leakage current of < 0.03 A. Installation must correspond with VDE 0107.  The ATMOS S 61 Servant vision is connected to a fixed connection which is to be mounted near the unit (max. 3 m, see fig.). Only qualified personnel authorised by ATMOS is allowed to proceed this.  The power consumption of the ATMOS S 61 Servant vision comes to 300 VA max.  An adequate number of socket outlets with earthing contact should be mounted for possible connection of further electrically operated units which may be installed at doctor‘s work station (e.g. installation of an electrically operated patient chair, camera, monitor, etc.) 8

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 LED stroboscope

Instrument deposit for 2 small trays ENT camera Camera head

Endoscope management for rigid, clean optics Disinfectant quiver Light port Automatic sensor barrier On/Off

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

9

4.0 4.2

Operation Connections Foot switch ENT camera Foot switch LED stroboscope Microscope









Foot switch microscope

Plug of fixed connection Equipotential bonding

Connections for light conductor (port 1-4)

Connections for LED (port 1-4)

Only one connection per port (either LED or light conductor) can be configured! First channel: Microscope (if applicable) / headlight (if applicable) / coldlight / LED / none Please note: Please take care that the protective cap on the light guide is only removed after having pulled the microscope light guide through the light conducting channel. Second channel: Headlight (if applicable) / coldlight / LED / none Third channel: Coldlight / LED / none Fourth channel: Coldlight / LED / none

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.

10

4.0

Operation

4.4 Light modules and controls Light modules Hook for headlight When the headlight is taken off the hook, it switches on automatically. The same way, when you hang it up again it switches off.

LED headlight

LED light source

Controls 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

- After switching on, the light module is displayed amongst the corresponding light port (LED, halogen or no display). The kind of display depends on the presetting from installing resp. your purchased options. - Activate light module by taking the cable out of the light port resp. take off the headlight. - In the case that more than one light guide is taken out, the last removed 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 immmediately after removal. - If two ports are activated resp. taken off: switch between them by using the foot switch or manually choose by pressing the button on the unit. It is only possible to activate one port! - Adjustment of brightness: Choose port, press the up/down button on the right side (possible: from 100% until 70%). When switching off the device the last adjustment will be kept. Burning time-inspection of halogen lamps Burning time of halogen lamps is controlled by the control system of the unit. After reaching 90% of the manufacturer stated lamp the LED light at the activation button glows orange instead of the usual green. Please keep in mind to get replacement lamps in time! After exchanging the lamp the service hour counter has to be set to “0”. Therefore keep the activation button of the light port pressed while switching on the unit. Pay attention: As life duration of halogen lights is subject to strong tolerances, the display can only be an approximate indication for life duration. No guarantee can be assumed that lamps cannot break before stated life duration! 11

4.0

Operation

4.5 Endoscope management 4.5.1 Overview

Metal quiver for storage of clean optics, optionally heating (removable) Plastics quiver for storage of used endoscopes and filling with disinfectant dilution (removable)

Please treat the instruments carefully, when inserting resp. removing.

4.5.2 Endoscope heating

41 - 42 °C 10 - 15 mins

!

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 and check the adjusted time prior to use! Please inform yourself about the maximal allowed residence time of instruments in the disinfectant dilution!!

12

4.0

Operation

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

Disinfection time adjusted

indicator light changes to red

keep pressed

Adjustment of disinfection time

Release button

Displayed illuminated segments

1

2

3

4

5

6

Time in mins

5

15

30

60

90

120 150 180 210 240

7

8

9

10

Perform disinfection

No disinfection

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.

13

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 for LED B Connection light source

Mains on/off switch

4.6.2 Camera head By switching on the unit 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 (LED, Halogen) has 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

14

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

3

click

read measured average values

Phonation

4.7.3 Operating the foot switch

Permanent light

Slow motion

Reflection of individual phases/positions of vocal cord oscillations

15

5.0

Cleaning

5.1 General information on cleaning and disinfection Prior to cleaning Medical devices like the ATMOS S 61 Servant vision must always be safe to operate. Therefore, we recommend prior to each application:

if necessary

5.1.1 Cleaning the unit surface  The surfaces of the ATMOS S 61 Servant vision are resistent against all surface disinfectants listed in chapter „Recommended disinfectant“.

 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. Long-term use of disinfectants with alcohol might affect the flexibility and transparency of the protective covers.



 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.

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

16

5.1.2

Instrument trays

 Before disinfection, thoroughly rinse the trays under running

water. You may, of course, add a cleanser (detergent) or surface disinfectant. • Use water to thoroughly rinse all residues of these substances. Trays made of anodized aluminium and melamine cannot be sterilized!

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 5.2

Cleaning Recommended instrument disinfectants

Manual disinfection of instruments Disinfectant Ingredients

(in 100 g)

Manufacturer

Korsolex basic (Application concentrate)

Glutaral (ethylene-dioxy)dimethanol tensides, salts, corrosion inhibitors

15.2 g 19.7 g

Bode Chemie, Hamburg

Korsolex extra (Application concentrate)

(ethylene-dioxy)dimethanol Glutaral Benzyl-C12-C18-alkyldimethylammonium chloride, tensides, didecylmethylammonium chloride corrosion inhibitors

15.3 g 7.5 g 1.0 g

Bode Chemie, Hamburg

neodisher Septo MED (Application concentrate)

dodecylbispropylentriamine didecyl dimethyl ammonium chloride non-ionic tensides, fragrances

9.2 g 13.0 g

Dr. Weigert, Hamburg

Sekusept aktiv (Application concentrate)

sodiumpercarbonate, phosphonates non-ionic tensides

Gigasept FF new (Application concentrate)

Ecolab, Düsseldorf

succinic acid dialdehyde 11.0 g dimethoxy tetrahydrofurane 3.0 g corrosion inhibitors Machine disinfection of instruments Dismoclean 24 Vario tensides, micro-encapsulated enzymes (Application concentrate) corrosion inhibitors complexing agent Dismoclean twin basic/twin zyme Dismoclean twin basic alkali dispenser, complexing agent corrosion inhibitors Dismoclean twin zyme surface active materials, enzymes, stabilisers, corrosion inhibitors

Schülke & Mayr, Norderstedt

neodisher MediClean forte (Application concentrate)

non-ionic tensides NTA (nitrilotriacetic acid) enzymes, preservative agent

Dr. Weigert, Hamburg

Sekumatic MultiClean (Application concentrate)

phosphates, silicates, potassium hydroxide corrosion inhibitors

Ecolab, Düsseldorf

Thermosept alka clean forte (Application concentrate)

non-ionic tensides anionic tensides, enzymes polycarboxyl, corrosion inhibitors

Schülke & Mayr, Norderstedt

5.3

<5 g 5-15 g

<5 g <5 g

Bode Chemie, Hamburg

Bode Chemie, Hamburg

Recommended surface disinfectants

Disinfectant

Ingredients

(in 100 g)

Dismozon pur (Application concentrate)

magnesium monoperoxyphthalate hexahydrate 80 g

Manufacturer Bode Chemie, Hamburg

Green & Clean SK alkyl-dimethyl-benzyl-ammonium chloride <1 g Metasys, Rum (Austria) (Application concentrate) dialkyl-dimethyl-ammonium chloride Perform Pentakalium bis(peroxymonosulfate)- Schülke & Mayr, Norderstedt bis(sulfate) 45.0 g

17 If using aldehyde-containing or amine-containing disinfectants at the same object, this may result in discolourations.

Cleaning and disinfection plan 6.0 Hygiene plan ATMOS S 61 Servant

S

Recommendations

Who Monthly

D

Disinfection Sterilisation

Weekly

C

Cleaning

When

Daily

Reusable parts

How After each procedure

What

Secretion canister Hose connection (nozzle)

X

X2,4,5

Cleaning and disinfection (automatic or manual)

X

Suction lid

X

X2,4,5

Cleaning and disinfection (automatic or manual)

X

Gasket

X

X2,4,5

Cleaning and disinfection (automatic or manual)

X

Daily exchange or when filter is blocked

X

Bacterial filter Splash protection

X

X2,4,5

Cleaning and disinfection (automatic or manual)

X

Float ball

X

X

Cleaning and disinfection (automatic or manual)

X

X

X2,4,5

Cleaning and disinfection (automatic or manual)

X

X

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

X

Exchange and disposal of full canister

X

Wipe cleaning and disinfection

X

Cleaning and disinfection (automatic or manual)

X

Suction hose in the canister Secretion collection canister Disposable canister system

X

Hose irrigation system Suction nozzle for hose irrigation Silicone attachment piece Suction nipple

Secretion suction hose Storage container for hose irrigation system

X

X3

X

X2,4,5,6

Exchange of the Silicone attachment Manual cleaning after each patient

X X2,4,5,6

X

Manual or automatic cleaning and disinfection Rinse the secretion hose with the hose irrigation system after each procedure;

X

X X

X2,4,5,6

Exchange or disinfection of the hose

X2,4,5,6

Cleaning with a brush; Manual or automatic cleaning and disinfection

X X X X

Ear irrigation / Thermal nystagmus stimulation Ear irrigation bowl

X

X2,4,5

Manual or automatic cleaning and disinfection

Handle

X

X3

Wipe cleaning and wipe disinfection

X

Jet connection

X

X2,4,5,6

Manual or automatic cleaning and disinfection

X

Splash protection

X

X

Cleaning and disinfection (automatic or manual)

2,4,5

Hose tip (disposable) Rinsing attachment

Rinsing bottle

X

Exchange after each application

X

Manual or automatic cleaning and disinfection

X

X

X2,4,5

X

X

Manual or automatic cleaning and disinfection

X

X2,4,5,6

Cleaning and disinfection; cleaning in the dishwasher with the glass care programme

X

Hygiene filter Rinsing lid with rinsing hose

X

See operating instructions for hygiene filter

X

2,4,5

X

Medication nebulisation / Politzer Handle for compressed air Sprayer jet Sprayer head

X X X

X

Manual cleaning and disinfection

X2,4,5,6

Cleaning after each application Manual or automatic cleaning and disinfection

X2,4,5

Multiple rinsing of the sprayer head with water

Hose at sprayer head

X

X

Sprayer bottle

X

X2,4,5,6

Politzer olive

X

X2,4,5,6

Politzer connection

X

X2,4,5,6

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

Manual or automatic cleaning and disinfection

X

X

X

Manual or automatic cleaning and disinfection

X

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

2,4,5,6

2,4,5

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

S

Disinfection Sterilisation

Who Monthly

D

Recommendations

Weekly

C

Cleaning

When

Daily

Reusable parts

How After each procedure

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

X2,4,5

Manual or automatic cleaning and disinfection

X

Instrument bowl with cover

X

X2,4,5

Cleaning with a brush; afterwards disinfection Manual or automatic cleaning and disinfection

X

ATMOS Cam 21 / 31

X

X3

Wipe cleaning and wipe disinfection

ATMOS Strobo 21 LED

X

X

Flexible scope

X

X1)

X1)

Immediate pre-cleaning after the procedure

X

Rigid scope

X

X1)

X1)

Immediate pre-cleaning after the procedure

X

Laryngoscope

X

X

X

Immediate pre-cleaning after the procedure

X

Light conductor

X

X3

Wipe cleaning and wipe disinfection

X

Light source

X

3

X

Wipe cleaning and wipe disinfection

X

Microscope

X

X3

Wipe cleaning and wipe disinfection

X

Headlight

X

X3

Wipe cleaning and wipe disinfection

X

X

X

Visualisation X

Wipe cleaning and wipe disinfection

3

1)

1)

X

Radiofrequency surgery ATMOS RS 221 (surface)

X

X3

Ergonomic plastic handles

X

X1,2,4,5

X1)

Wipe cleaning and wipe disinfection

X

Bipolar tweezers

X

X1,2,4,5

X1)

Bipolar electrode

X

X

X

Immediate pre-cleaning after the procedure cleaning and disinfection (automatic or manual); use of enzymatic detergents

X

1,2,4,5

Bipolar electrode cable

X

X1,2,4,5

X1)

X

Neutral electrode

X

1,2,4,5

X

X

Immediate pre-cleaning after the procedure cleaning and disinfection (automatic or manual); 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 the procedure cleaning and disinfection (automatic or manual); use of enzymatic detergents

Housing

X

X3

Wipe cleaning and wipe disinfection

X

Roller shutter

X

X3

Wipe cleaning and wipe disinfection

X

System frame

X

X3

Wipe cleaning and wipe disinfection

X

Drawers

X

3

X

Wipe cleaning and wipe disinfection

X

Writing surface

X

X3

Wipe cleaning and wipe disinfection

X

Instrument deposit

X

X3

Wipe cleaning and wipe disinfection

X

Mirror pre-heater

X

X

Wipe cleaning and wipe disinfection

X

Tongue patches and swab dispenser

X

X3

Waste disposal

X

X

Instrument tray

X

X3

Wipe cleaning and wipe disinfection

1)

1)

X

X

X

X

Surfaces

3

Wipe cleaning and wipe disinfection, every day or when refilling Wipe cleaning and wipe disinfection, every day or when emptying the container Wipe cleaning and wipe disinfection, daily when replacing with new instruments

3

Recommended disinfectants

Important information Wipe cleaning and wipe 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.

3)

Surface disinfection for coated surfaces:

 Green & Clean SK (ATMOS)  Dismozon® pur (Bode Chemie)  Kohrsolin® FF (Bode Chemie)  Perform® (Schülke & Mayr)  Terralin® Protect (Schülke & Mayr)

Other surfaces:

       

4)

          

Instruments - manual disinfection: Korsolex® 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)

5)

        

Dismozon® pur (Bode Chemie) Kohrsolin® FF (Bode Chemie) Bacillocid® rasant (Bode Chemie) Mikrobac® forte (Bode Chemie) Perform® (Schülke & Mayr) Terralin® Protect (Schülke & Mayr) Surface disinfection FD 312 (Dürr Dental) Quick disinfection B 30 (Orochemie)

1) 2) 6)

Please observe the manufacturer‘s operating instructions. Alternative to manual cleaning und disinfection: Wash-Disinfector 78°C / 172°F Material dimensionally stable at 134°C

Instruments - automatic disinfection: Dismoclean® 21 clean (Bode Chemie) Dismoclean® 24 Vario (Bode Chemie) Dismoclean® 28 alka one (Bode Chemie) Dismoclean® twin basic/twin zyme (Bode Chemie) neodisher® FA (Dr. Weigert) neodisher® FA forte (Dr. Weigert) neodisher® MediClean forte (Dr. Weigert) Thermosept® alka clean forte (Schülke & Mayr) Thermosept® RKN-zym (Schülke & Mayr)

Please see the manufacturer‘s instructions for concentration, contact time, temperature and the compatibility of materials.

Wrong concentration of disinfectants may lead to damage!

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“. The medical products were categorised in the risk groups uncritical, semicritical 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

REF 534.2103.0

2013-12 Index: 07

7.0

Maintenance and servicing

 A safety related control has to be proceeded each year. Additionally we recommend a yearly maintenance according to service insructions.

7.1 Replacement of fuse 7.1.1 Earthing contact socket outlet

7.1.2 Fixed connection

7.2 Changing bulbs

!

Prior to opening the device switch off the mains switch and pull the mains plug out of the socket!

!

Please note that used halogen lamps can still be hot! Never directly touch the head of a new lamp with your fingers! Use a soft cloth.

A)

Loosen the screws at the front of the unit.

B)

Loosen the lever downwards.

20

Carefully open the cover towards the front. Attention: the cables are connected to the unit!

Take out the lamp to the front

Carefully pull out the used lamp to the front out of its holder.

Put in the new lamp and check correct positioning.

8.0

Trouble shooting

Description

Possible cause

Procedure

Illuminated light on halogen port glow constantly red

> Fan is defective

Contact ATMOS service!

> Fan is blocked

Switch unit off and on again

No light

> Lamp is broken

Replace lamp

> Electronics defective

Contact ATMOS service!

> Fuse for halogen transformer is defective

Contact ATMOS service!

LED at the activation button glows orange instead of green

> 90% of the manufacturer stated halogen lamp duration is reached.

Please purchase replacement lamp.

Green control light at mains switch does not glow,device does not work

> AC power line not connected

Connect AC power line

> Device fuse is defective

Replace fuses

Green control light at mains switch glows,but device does not work

> AC power line defective

Contact ATMOS service!

> AC power line fuse defective

Contact ATMOS service!

> foot switch not or not correct connected

Connect foot switch correctly to device

> foot switch defective

Replace foot switch

> Just one light port available

If required refit by an ATMOS specialist.

> Cable of switching contact is not or not correctly connected

Connect cable correctly to device

> Switching contact in microscope column is defective / misaligned

Contact ATMOS service!

Light module

Foot switch No switch of light port when using the foot switch

Microscope No activation / deactivation of microscope light port via microscope column

21