Atmos Scope User manual

1
Operating Instructions
ATMOS Scope
English
GA1GB.150259.0
2022-03 Index 03

2
Table of contents
1 Introduction...................................................................................................... 4
1.1 Notes on operating instructions..............................................................................4
1.2 Explanation of pictures and symbols......................................................................6
1.3 Intended purpose .....................................................................................................9
1.4 Function....................................................................................................................11
1.5 Scope of delivery .....................................................................................................11
1.6 Transport and storage ............................................................................................13
2 Notes for your safety..................................................................................... 15
2.1 General safety instructions....................................................................................15
2.2 Danger for users, patients, and third parties ......................................................15
2.3 Avoiding damage to the device .............................................................................17
3 Setting up and starting up ............................................................................ 18
3.1 Device overview.......................................................................................................18
3.2 Leakage tester and tube.........................................................................................19
3.3 Combination with other devices ...........................................................................19
3.4 Preparing the device ...............................................................................................20
3.5 Assembly and initial installation............................................................................20
3.5.1 Required additional devices...............................................................................20
3.5.2 Installation of ATMOS Capture Suite Basic.......................................................20
3.5.3 Installation of the ATMOS Scope using ATMOS Capture Suite Basic.............21
3.6 Checks and tests......................................................................................................21
3.6.1 Checking the glass surfaces...............................................................................22
3.6.2 Performing a leakage test ..................................................................................22

3
4 Operation........................................................................................................ 25
4.1 Use/operation..........................................................................................................25
4.1.1 Switching on and adjusting the system............................................................25
4.1.2 Functions of the buttons with the ATMOS Capture Suite...............................25
5 Reprocessing................................................................................................... 27
5.1 Safety instructions for reprocessing .....................................................................27
5.1.1 General safety instructions................................................................................27
5.1.2 Danger for users, patients, and third parties ..................................................28
5.1.3 Avoiding damage to the device .........................................................................28
5.1.4 Further cleaning instructions.............................................................................30
5.2 Preparing and completing reprocessing ..............................................................30
5.3 Preparing surfaces ..................................................................................................31
5.3.1 Overview...............................................................................................................31
5.3.2 Selecting process chemicals...............................................................................32
5.3.3 Manual cleaning and disinfection .....................................................................35
5.3.4 Mechanical cleaning and disinfection...............................................................37
5.3.5 Sterilization ..........................................................................................................39
6 Maintenance and service.............................................................................. 40
6.1 Periodic tests ...........................................................................................................40
6.2 Sending in the device..............................................................................................40
6.3 Warranty...................................................................................................................41
7 Troubleshooting ............................................................................................. 42
8 Accessories ..................................................................................................... 46
9 Disposal........................................................................................................... 47
10 Technical data ................................................................................................ 48
11 Notes on EMC ................................................................................................. 50

4Introduction
1 Introduction
1.1 Notes on operating instructions
These operating instructions contain important instructions on how to
operate your product safely, correctly, and e ectively.
These operating instructions are designed for training and instructing
new operating personnel in the use of the system, and they are also
intended for use as a reference manual. This document may only be re-
printed, either in part or in whole, with written permission from ATMOS.
These operating instructions must always be kept available near
the product.
Care, periodic tests, regular cleaning, and proper application are essen-
tial. They ensure the operational safety and usability of the product.
Maintenance, repairs, and periodic tests may only be carried out by
persons who have the appropriate technical knowledge and who are
familiar with the product. To carry out these measures, the person must
have the necessary test devices and original spare parts.

5
Introduction
Read chapter “2 Notes for your safety” on page 15 before using the
product for the  rst time. This will help you to avoid potentially danger-
ous situations.
This device bears the CE marking CE in accordance with the European
Medical Device Regulation (MDR) 2017/745.
The product complies with all applicable requirements of Directive
2011/65/EU on the restriction of the use of certain hazardous substances
in electrical and electronic equipment (“RoHS”).
The Declarations of Conformity and our General Terms and Conditions
can be viewed on our website at www.atmosmed.com.
The quality management system at ATMOS has been certi ed according
to international standard EN ISO 13485.
These operating instructions are valid for the following devices:
• ATMOS Scope 507.7000.0
• ATMOS Scope Pro 507.7050.0
• ATMOS Scope iPrime 507.7060.0

6Introduction
1.2 Explanation of pictures and symbols
In the operating instructions
DANGER
Warning of a danger that will result in immediate fatal or serious injury. Observe
the necessary measures.
WARNING
Warning of a danger that can cause fatal or serious injury. Observe the necessary
measures.
CAUTION
Warning of a danger that can cause minor injury. Observe the necessary measures.
NOTICE
Notice of a danger that can damage the product or other objects. Observe the
necessary measures.
Warning of a danger that can cause fatal or serious injury.

7
Introduction
Notice of potential material damage.
&Useful information on the handling of the device.
1. Action. Proceed step by step.
»Result of an action.
Move, plug in this direction.
click Engage, check correct  t.
On device and type plate
Follow operating instructions (blue)
This device complies with the relevant requirements of EU regulations.
UL Recognized Component
Manufacturer

8Introduction
Date of manufacture
DE Country of manufacture: Germany
Serial number
Reference number
IP68 Degree of protection
Protection class II device
Professional disposal
Type BF applied part
Medical device
This device complies with the relevant requirements
of the Eurasian Economic Union.

9
Introduction
1.3 Intended purpose
Product name: ATMOS Scope
Main functions: For short-term endoscopic application in natural orices
for the visualization of existing structures
Intended purpose: For endoscopic examination in humans
Intended users / User
prole:
Doctors and medical specialists who are specially
trained in the handling of endoscopes.
Intended patient target
group:
Patients of all age groups without restrictions in whom
an endoscopic examination is generally indicated. The
use of the device also depends on the patient’s general
condition and must therefore be critically evaluated by
the responsible physician before each use.
Medical conditions to
be diagnosed, treated or
monitored:
Endoscopy can be performed whenever visual inspec-
tion of the internal anatomy of the dened organs is
necessary.
Application organ: Ear, mouth and pharynx, nose

10 Introduction
Application period: Transient (< 60 min)
Application environ-
ment:
Outpatient medical facilities, e.g., ENT practices, hospital
outpatient departments, medical care centers
Patient selection
criteria:
None
Indications: Need for visual inspection of anatomy in dened organs
Medical contra-indica-
tions:
Non-intact mucosa in the area of the application organs
Other contra-indica-
tions:
None
Warnings: None
The product is: active
Sterility/specic micro-
bial status:
Non-sterile
Single use product /
reprocessing:
Not a single-use product. Reprocessing according to
instructions for use.

11
Introduction
1.4 Function
The exible ATMOS Scope with integrated camera and LED light source combines all
required components in the handle:
• LED light source
• Camera electronics
• Mechanics for controlling the deection
Thanks to optimized video pre-settings, manual camera setting and white balance
are no longer required.
1.5 Scope of delivery
Prior to dispatch, the ATMOS Scope was subjected to an extensive functional test and
was carefully packed. Nevertheless, please compare the contents of the shipment on
completeness immediately upon receipt (see delivery note).
Description REF
ATMOS Scope
Set includes:
• Endoscope
• Adapter for leakage test
• Attachment for pressure compensation including information
tag on pressure compensation
• Infection control return bag
507.7000.0

12 Introduction
ATMOS Scope Pro
Set includes:
• Endoscope
• Leakage tester
• Adapter for leakage test
• Attachment for pressure compensation including information
tag on pressure compensation
• Infection control return bag
• ATMOS Capture Suite Basic
507.7050.0
ATMOS Scope iPrime
Set includes:
• Endoscope
• Leakage tester
• Adapter for leakage test
• Attachment for pressure compensation including information
tag on pressure compensation
• Infection control return bag
• ATMOS Capture Suite HD
507.7060.0

13
Introduction
ATMOS Scope Software ATMOS
Capture Suite Basic
installation on USB
 ashdrive
Operating Instructions
1.6 Transport and storage
Only transport the device in a shipping carton that is padded and o ers su cient
protection.
If damage occurs during transport:
1. Document and report damages in transit.
2. Send the device to ATMOS (see chapter “6.2 Sending in the device” on page
40).

14 Introduction
Environmental conditions for transport and storage:
• Temperature range −30...+50°C
• Air humidity without condensation 5...90 %
• Air pressure 700...1060 hPa
&Please observe the notes on pressure compensation (screw on the adapter).

15
Notes for your safety
2 Notes for your safety
Please read and pay attention to the safety instructions prior to using the product.
2.1 General safety instructions
Only use accessories and options that are specically suited for combination with the
product and that meet the performance and safety requirements.
The PC used must comply with the standard IEC 60950-1 or IEC 62368-1, respectively.
If you wish to connect more than one device or applied part, you must always
observe their safety instructions.
Report all serious incidents that have occurred in connection with this product to the
manufacturer and your national competent authority.
2.2 Danger for users, patients, and third parties
Electric shock due to unsuitable power connection, incorrect handling of the
product, or damage to product components
Minor injuries are possible.
• Prior to each use, check the device and cable for damage. Do not operate the
device if you notice any damage. Check the device for leak tightness (see chapter
“3.6.2 Performing a leakage test” on page 22). Do not operate the device if the
leakage test is failed. In this case, clean and disinfect the device and send it to
ATMOS for repair.

16 Notes for your safety
• You can only disconnect the device from the power supply by pulling out the
power cable.
• Position the device in such a way that you can easily disconnect it from the PC/
laptop at any time.
• Never touch the power plug or power cable with wet hands.
• Use only original accessories and original spare parts from ATMOS.
• Follow the instructions regarding periodic tests (see chapter “6.1 Periodic tests”
on page 40).
• Assembly, new settings, modications, extensions, and repairs may only be
carried out by authorized persons.
• Do not modify the device without the manufacturer’s permission.
• During prolonged use of the ATMOS Scope, the distal endoscope tip can heat up
to 53.5 °C.
• Never leave the patient unattended near the device.
Keep the device fully functional at all times.
Malfunctions could cause injury to you and your patients.
• Please observe the notes on the electromagnetic compatibility (EMC) of the
device.
• ATMOS recommends: Only use original ATMOS software.

17
Notes for your safety
Risk of infection due to pathogens on the product!
Diseases can be transmitted.
• Always wear disposable gloves when using the product.
• Clean and disinfect the device according to the operating instructions (see
chapter “5 Reprocessing” on page 27).
2.3 Avoiding damage to the device
Unsuitable mechanical stress.
Damage to the USB cable and the distal tube of the ATMOS Scope is possible.
• Make sure that both the USB cable and the distal tube are not pinched,
squeezed, knotted, or clamped o.
• Do not pull on the USB cable or distal tube of the ATMOS Scope. The pressure
compensation valve may only be used with ATMOS accessories and can be xed
without tools.
Storage and operation in an unsuitable environment.
The product may become damaged.
• Please observe the ambient conditions for transport, storage, and operation.

18 Setting up and starting up
3 Setting up and starting up
3.1 Device overview

19
Setting up and starting up
3.2 Leakage tester and tube
Set for leakage tester REF 507.7031.0 (leakage tester REF 507.7030.0
and adapter for leakage tester to hose REF 507.7024.0)
Adapter for leakage test to tube REF 507.7024.0
3.3 Combination with other devices
Only quali ed personnel are authorized to install electrical systems. The manufactur-
er of an electrical medical system is responsible for ensuring that the performance,
safety, technical data, and intended use of the ATMOS Scope are not impaired.
Observe the following information when connecting the device in the required
combination:

20 Setting up and starting up
• Refer to the speci cations of IEC 60601-1 on medical electrical systems.
• Pay particular attention to the information on the patient environment and
leakage currents.
3.4 Preparing the device
Risk of injury and risk of infection due to production residues.
1. Prior to  rst use, reprocess the product according to the operating instructions.
2. Check the leak tightness of the ATMOS Scope according to the operating instruc-
tions (see “3.6.2 Performing a leakage test” on page 22).
3. Prior to use, the live image should be checked.
3.5 Assembly and initial installation
3.5.1 Required additional devices
Please use a PC or an equivalent system (in accordance with IEC 60950-1 or IEC
62368-1, respectively).
3.5.2 Installation of ATMOS Capture Suite Basic
1. Insert the supplied USB  ashdrive into the designated jack.
2. Launch “Install.exe”.