ATMOS Cam 21/31 Operating Instructions Index 10 July 2019

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 689-292 (Service Centre)

[email protected] www.atmosmed.de 2

Table of contents 1.0 1.1 1.2 1.3 1.4 2.0

Introduction... 4 Notes on operating instructions... 4 Explanation of pictures and symbols... 5 Intended use... 6 Function... 6 Hints for your safety... 7

3.0 3.1 3.2 3.3 3.4 3.5 3.6 4.0 4.1 4.2 4.3 4.4 4.5 4.6 4.7 5.0 5.1 5.2 5.3 5.4 5.5 6.0 6.1 6.2 6.3 6.4 7.0

Setting up and starting up... 9 Scope of delivery... 9 Connections and operating elements... 9 Digital monitor outlets... 12 Setup... 12 Fitting the holder for the camera head (not applicable for ATMOS Roadster)... 12 Start up... 14 Operation... 16 On / Off switch... 16 Adjust application profiles... 16 Camera head... 17 Images-storage mode... 18 SD card (Cam 31 / DV / Data)... 19 LED light source (option)... 20 Manual white balance... 21 Cleaning and care... 22 General information on cleaning and disinfection... 22 Control unit... 22 Camera head with video adapter... 22 Chemical disinfection... 23 Surface disinfectants... 23 Maintenance and Service... 24 Fuse exchange... 24 Period tests... 24 Pixel error correction... 25 Sending in the device... 25 Troubleshooting... 26

8.0 8.1 8.2 8.3 9.0

Accessories and spare parts... 27 Accessories... 27 Options... 30 Spare parts... 30 Technical data... 31

10.0 10.1 10.2 11.0

Check-up / Disposal... 33 Checking ATMOS devices... 33 Disposal... 33 Arrangement... 34

12.0

Notes on EMC... 35

13.0

For your notes... 39

3

1.0 Introduction Information on the device versions Compared to the ATMOS Cam 21, the ATMOS Cam 31 has an additional image memory. The DV versions also have a USB-connection to conduct the video signal to the PC. ATMOS

Cam 31

Image memory:

Cam 21 DV

Cam 31 DV

Cam 31 DV Data

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Outputs: FBAS S-Video

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HDMI

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-

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Digital Video Streaming: USB Display of symbols

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SD card

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Audio in / out

-

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1.1 Notes on operating instructions In the following all device versions, as well as all modules and table-top devices are named ATMOS Cam 21/31. These operating instructions contain important notes on how to operate the ATMOS Cam 21 / 31 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 Cam 21 / 31 and are therefore a must besides regular cleaning. Repair work and period tests may only be carried out 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 Cam 21 / 31 will be preserved.

The product ATMOS Cam 21 / 31 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 Cam 21 / 31 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.

4

Introduction

1.2 Explanation of pictures and symbols Icons and symbols in the operating instructions

TIPP

The symbol warns you against dangerous situations Always pay attention to the instructions in this manual.

This symbol indicates situations by which your device could be damaged.

Useful information on the handling of the device.

Engage, check correct fit

Please press where dot indicates

Move, plug... in this direction

Activate the optional foot switch

Turn, shift... in this direction

Check

Replace

Shortcuts on the device Fuse according to IEC 417/5016, DIN 30600/0186 Application part type BF

~

Signal Input, Y/C, FBAS, Audio

Potential equalisation

Signal Output, Y/C, FBAS, Audio, USB Interlink / Data

Ground wire connection

Foot switch

Alternating current

On (feed-in, power connection)

Observe operating instructions

Off (feed-in, power connection)

Follow operating instructions (blue)

Control keys ATMOS Cam 21 / 31 Endoscope

Laryngoscope / Endoscope

Usage: Examination of nose and ears • Hysteroscopy Typ. ø: 2.7 and 4 mm respectively Typ. angles: 0°, 30°, 45°, 70°

Usage: Laryngeal examinations • Hysteroscopy Typ. ø : 10 mm Typ. angles: 70°, 90°

Flexible Endoscope / Hysteroscope

Microscope/ Colposcope

Usage: Nose, throat, larynx examinations • Hysteroscopy

Usage: Examination of ears • Colposcopy

Xenon light source

Halogen light source

Typical: 180 W resp. 300 W Colour temperature: 5600-5800 K

Typical: 150 resp. 250 W Colour temperature: 3200 K

Stroboscope flashlight source (ENT)

LED light source Typical: 2 W (e.g. ATMOS LED light source and LED headlight -please see accessories in chapter

Usage: Laryngo-stroboscopy Colour temperature: 5800 K

8.0).

Introduction

5

1.3 Intended use Name:

ATMOS Cam 21 / 31

Main functions:

The ATMOS Cam 21 / 31 is an ENT camera for displaying the examination image on a screen or a PC.

Medical indications / The camera is intended to be connected to common application: ENT-endoscopes with a standard ocular and to a microscope with a beam splitter. Specification of the main function:

Camera head: High-definition CCD-camera with a high sensivity to light and large depth of field, connection to endoscopes, an easy changing of endoscopes, control possibility for digital zoom, a simple focusing possibility, automatic white balance Control unit: Simplest camera setting, selection of the optical instrument, selection of the type of light, supply interface for LED light source, 2 analogue (1 x Y/C (S-Video) and 1x FBAS (Composite)) and 2 digital (2 x HDMI) monitor outputs.

Application organ:

Ear, nose, throat

Application time:

Temporarily (max. 60 minutes)

Application site:

In clinics and practices for ENT doctors and phoniatricians. The camera may only be operated and applied by medically trained staff.

Contraindications:

Not intended for use in explosion-hazardous areas.

The product is:

X active □ not active

Sterility:

Not necessary

Single-use product / reprocessing:

No single use product

1.4 Function The ATMOS Cam 21 / 31 consists of a camera head and the control unit. Both elements are connected detachably via a cable of 3 m length. The camera head includes a 1/3“ CCD colour image sensor with microlenses for connection to commercially available endoscopes with standard ocular objectives. Only applicable for ATMOS Cam 21 / 31 DV: For Windows 7 and MAC OS 10.x the camera can be directly connected to a computer due to the USB interface and the audio-in and therefore a transmission in digital format is possible. Therefore the camera can be connected to PCs with USB, without any additional hardware. Starting from Windows 8 a SD-Grabber must be used.

6

Introduction

2.0 Hints for your safety The safety of the ATMOS@ Cam 21 / 31 complies with all the recognized rules of technology and the guidelines of the Medical Products Law. Read and follow the safety instructions carefully before using the product.

General safety information The ATMOS Cam 21 / 31 is: • designed in line with IEC 60601-1 / EN 60601-1. • assigned to VDE safety class I • assigned to class I of the German law on medical products. The ATMOS Cam 21 / 31 fully complies with the electromagnetic immunity requirements of standard IEC 60601-1-2 / EN 60601-1-2 "Electromagnetic compatibility – Medical Electrical Equipment". Pay also attention to the safety information of the attached devices / parts. 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. Please check the delivery on completeness and intactness. The ATMOS Cam 21 / 31 may be used in supervised operation by qualified personnel only which has been authorised by ATMOS and which has been trained for operating the appliance (IEC 60601-1/EN 60601-1). Pay also attention to the safety information of the attached devices / parts as well as to the safety informations in the following chapters. For the camera head only extension cables with maximum 2 m length may be used. In case of an insufficient illumination the examination has to be cancelled respectively a brighter light source has to be used. The warranty will be rendered invalid in case of damages caused due to the utilization of accessories or consumables which are not approved by ATMOS for use with this unit. Clean and disinfect the camera in regular intervalls (peruse chapter 5.0).

Dangers for users, patients and third parties Protect yourself against an electric shock! • • • • • •

To disconnect the device from the mains supply, first remove the plug from the wall outlet. Disconnect the connection line on the device afterwards only. Prior to cleaning, switch off the device and separate it from the mains supply resp. from other devices. Never touch the device’s interfaces and the patient at the same time! Do not touch the cables or plugs wit wet hands! Check the device and connection lines for defects prior to the use of the device. Damaged cables must be replaced!

Danger of explosion! •

The ATMOS Cam 21 / 31 is not designed for the use in medical areas with an explosion hazard or which are oxygenated. Explosion-hazardous areas may be caused by the use of flammable anaesthetics, skin cleansing products and skin disinfectants. Hints for your safety

7

Damage to the device Prior to first starting up, check whether the mains voltage specified on the type plate matches the local mains voltage. For mains supply, only use the power cable supplied (or an equivalent one). The device may only be connected to a properly installed protective contact socket. A medical insulating transformer with earth leakage monitor or any similar safety system acc. to EN 60601-1 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. Pay attention to the ambient conditions specified in chapter 9.0. The ATMOS Cam 21 / 31 may not be operated with units not complying with the requirements of standard EN 60601-1 "Medical Electrical Equipment" and EN 60601-1-2 "Electromagnetic compatibility (Medical Electrical Equipment)". Check proper assignment when assembling country-specific connections: green/yellow: non-fused earth conductor, blue: neutral conductor, black or brown: phase Do only use the recommended accessories and compounds. Protect the device against direct solar radiation and keep it away from heaters. The lens of the focusing optic should be protected against mechanical contact.

8

Hints for your safety

3.0 Setting up and starting up 3.1 Scope of delivery ATMOS

Cam 21 DV

Cam 31 Cam 31 DV

Cam 31 DV Data

Camera housing

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Holder for camera head

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Camera head

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Foot switch for image storage Data transfer cable

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Audio cable for stroboscope audio channel incl. adapter plug

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S-Video cable

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Cable and adapter HDMI to DVI

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USB cable

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SD card

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Operating Instructions

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3.2 Connections and operating elements

Patient

at least 1.5 m from video components which do not correspond to EN-60601-1

Non-medical product

For guaranteeing shortest connecting paths, the video components (recorder, printer, monitor, etc.) should be positioned near to the ATMOS Cam 21 / 31. Please pay attention to operate all video components from one mains distributor. All additional equipment which is connected to the analogue and digital interfaces of the device must meet the requirements of relevant EN specifications (for inst. EN 60950 for data processing equipment and EN 60601-1 for electrical medical equipment). In addition, configurations must satisfy system specification EN 60601-1-1: 2001. When additional equipment is connected to the signal input or signal output section on the device, the person carrying out the connection is deamed „a system configuration operator“ and as such is responsible for meeting the requirements of system specification EN 60601-1-1: 2001. For answers to additional questions, please contact your local specialist supplier or the ATMOS Technical Service. Please note that the use of components other than listed in chapter 8.0 may have a negative influence on the image quality due to flickering and image drop outs.

Setting up and starting up

9

Forefront

A

B

1 A

2

Buttons for selecting application part and light source

B Mains on/off switch 1

Connection for camera head

2

Connection for LED light source

Rear side of the Cam 31 5

5

SD card

7, 8

7

8

9

10

11

12

Connection for HDMI video output 9 Connection for video output (Y/C) 10 Connection for video output (FBAS) 11 Connection for rear side video input (Y/C) 12 Connection for rear side video input (FBAS)

Nut for mains supply Connection for potential equalization 18 Connection for foot switch 16 17

16

10

Setting up and starting up

17

18

Rear side of the Cam 21 DV / 31 DV 3

5 3 5

7

8

9

10

11

12

13

14

15

USB SD card

7 , 8 Connection for HDMI video output 9 Connection for video output (Y/C) 10 Connection for video output (FBAS) 11 Connection for rear side video input (Y/C) 12 Connection for rear side video input (FBAS) 13 Audio output (line level) 14 Audio input 15 Line-In M/C in

Nut for mains supply 17 Connection for potential equalization 18 Connection for foot switch 16

16

17

18

Rear side of the Cam 31 DV Data 3

4

5

3 4 5

7

8

9

10

11

12

13

14

15

USB Data gateway SD card

7 , 8 Connection for HDMI video output 9 Connection for video output (Y/C) 10 Connection for video output (FBAS) 11 Connection for rear side video input (Y/C) 12 Connection for rear side video input (FBAS) 13 Audio output (line level) 14 Audio input 15 Line-In M/C in

Nut for mains supply 17 Connection for potential equalization 18 Connection for foot switch 16

16

17

18

Setting up and starting up 11

3.3 Digital monitor outlets The cameras ATMOS Cam 31 DV and ATMOS Cam 21 DV feature a digital monitor output with SXGA signal. The resolution of the monitor has to be at least 640 x 480 pixel. Please note that only the digital or analogue video outputs can be activated.

3.4 Setup Possible settings: • • •

Video-input Audio-input Date and time 1. Connecting the inputs, e.g.

2.

Video input Y/C

Video input FBAS

4.

3. Initialization phase

when all the LEDs are illuminated: The LED key Press the desired application flashes. profile. 5.2 Video input

5.3. Audio input

• Video input Y/C • Video input FBS • Standard-camera head

• Microphone-In • Line-In

5.1 Setting the video and audio: • the same application profile key: select one of the inputs. • another application profile key: Save the input and go to the next setting.

6.1 Setting the date and time:

+ - (only for year!) • other application profile keys: Save the input and go to the next setting

6.2 Setting the date and time:

7.

• Year • Month • Day • Hour • Minute

• Select any function.

a Using the cam

b Setting other optics:

to 1.

3.5 Fitting the holder for the camera head (not applicable for ATMOS 12

Setting up and starting up

Roadster) 1.

4.

2.

3.

5.

insertion like application part q.v. Chapter 4.3.1

Setting up and starting up 13

3.6 Start up Please pay attention, just to switch on the devices after they have been completely wired. If required, analogue peripheral video equipment (monitor, video printer, etc) must be adjusted to NTSC video norm. For further details please look at the corresponding operating instructions. 1.

2. Optional

4.

3. Valid for Cam 21 / 31 DV

Y/C / S-VHS

HDMI / DVI

FBAS (composite) / VHS 5. Valid for Cam 31 / DV / Data

14

Setting up and starting up

6.

3.6.1 Connection diagram ATMOS Cam 21 / 31 Data

digital

analogue ATMOS Strobo 21 LED (valid for cameras “Data“) FBAS-videosource e.g. ATMOS Scope

Computer

S-video source (Y/C) e.g. ATMOS i View (microscope)

• to Windows 7 USB Streaming

external microphone REF 507.1806.0

ATMOSoft

ATMOS Strobo 21 LED (valid for cameras “DV“ and “Data“)

ATMOS Cam 31 DV DATA valid for: CAM 31 CAM 31 DV CAM 31 DV DATA

Cable and adapter for monitor: Digital HDMI/DVI-adapter

REF 507.5451.0

HDMI-cable

REF 008.0913.0

Analogue Cable video S-VH (Y/C)

REF 008.0635.0

Cable video FBAS

REF 008.0844.0

Setting up and starting up 15

4.0 Operation 4.1 On / Off switch

Standard camera head or Last selected mode

Initialization phase: All lights are on.

wait at least 10 sec.

4.2 Adjust application profiles 2.

1.

select the connected instrument

select type of light source

Automatic configuration of the optimum camera parameter. Endoscope

Xenon light source

Laryngoscope/ Endoscope

Halogen light source

Flexible Endoscope / ATMOS Scope Hysteroscope Microscope / Colposcope

16

Operation

Stroboscope flashlight source (ENT)

LED light source

4.3 Camera head 4.3.1 Inserting / replacing the application part 1.

2.

click

4.3.2 Focussing / image definition Pre-adjustment

During the examination

4.3.3 Digital zoom Amplification and miniaturisation of examination image. Zoom steps: 1.0 x / 1.5 x / 2.0 x / 4.0 x.

Operation 17

4.4 Images-storage mode Only applicable for ATMOS Cam 31 / DV / DATA. Live mode: Displays live images of the examination. White balance and zoom are possible. Memory mode: - 1-image memory mode: One examination picture is saved on the SD card and displayed in full screen size.

• •

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4-images memory mode: Four examination pictures or up to three examination pictures and the live picture are displayed simultaneously.

1-image memory mode When you insert an SD card the picture will be saved. 1. Live

3. 1-image memory

2.

short live

no SD-Card still

4-images memory mode When you insert an SD card every picture will be saved. 1. Live

3. 4-images memory mode : live

2.

live

2 - 3 sec.

live

4.

short

5. 4-image memory

6.

short

live

1

7. 4-image memory

2

1

live

8.

9. 4-images memory:

10.

11. Live

...

18

Operation

1

2

3

4

2-3 sec.

live

4.5 SD card (Cam 31 / DV / Data) The SD card cannot be used if the ATMOS Cam 31 / DV / Data is integrated in a treatment unit (e.g. ATMOS S 61 Servant). If necessary remove the memory protection from the SD card and insert it with the printed side up. Pay attention to the operating instructions of the SD card. You can insert and remove the SD card in the live mode. Make sure you do not press any other key. TIPP

If there are a lot of pictures on the memory card then storage takes longer.

Save 1. Live

2.

3. SD card

short

4.

5. Live

short

live

live

Pic stored still

Display The image with the most recent date will be shown first. From the most recent picture via + return to the Live-Mode. 1. Live

2.

live

+ approx. 3 sec. 5.

4.

+

1

recent date

-

2

older date

3. SD card

- approx. 3 sec.

P -01

6. Live

live

Operation 19

4.6 LED light source (option) 1.

2.

3.

4. click

20

Operation