InfantView Instructions for Use V01/16

Manufacturer: ACUTRONIC Medical Systems AG Fabrik im Schiffli 8816 Hirzel Switzerland

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Table of Contents 1

Important information ... 5

1.1 1.2 1.3 1.4 1.5 1.6 1.7 1.8

Notes about the Instructions for Use ...5 Note, caution, warning ...5 Sterility ...5 Controls ...6 Approved connection combinations...7 Approved applications ...8 Device-specific changes ...8 Symbols ...9

2

Safety ...11

2.1 2.2 2.3 2.4 2.5 2.6

Intended use ...11 User's qualification ...11 Safety measures...11 Contraindications ...11 Device check ...11 Safety information...12

3

Device description ...14

3.1 3.2

Front view of the ControlUnit ...14 Rear view of the ControlUnit ...15

4

Putting into operation ...16

4.1 4.2

Main unit ...16 Accessories ...17 Connecting accessories to the LIGHT/CAMERA sockets ... 17 VisionHandle with LaryngoBlade ... 18 VeinFinder ... 20 ThoraxShine ... 20 EndoCamera Head, EndoTV Coupler and EndoLight Source ... 21

4.3

Optional ports ...22 USB port... 22 S-Video ... 22

5

Operation ...23

5.1

Main unit ...23 Switching ON/OFF... 23

5.2

Accessories ...24 CAMERA socket ... 24 LIGHT socket ... 25

5.3 5.4 5.5

Adjusting a camera image ...26 On-screen display ...27 USB image saving ...28

6

Cleaning, disinfection, sterilisation ...29

6.1

Detaching ...29

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6.2 6.3 6.4 6.5 6.6 6.7 6.8

ControlUnit ...30 EndoCamera Head and EndoTV Coupler ...31 EndoLight Source ...32 VisionHandle ...32 LaryngoBlade ...33 VeinFinder ...34 ThoraxShine ...35

7

Maintenance ...36

7.1 7.2 7.3

Servicing ...36 Inspection ...36 Repair ...36 Button cell for USB image saving... 36 Changing the fuse ... 37

7.4 7.5 7.6 7.7 7.8

Responsibility...37 Warranty ...37 Returning goods ...37 Disposal ...38 Conformity ...38 Directive conformity ... 38 Standard conformity ... 38

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8

Troubleshooting ...39

9

Specifications ...40

9.1 9.2 9.3 9.4 9.5 9.6 9.7 9.8 9.9 9.10 9.11

General ...40 Control Unit ...40 VisionHandle ...41 EndoCamera Head ...42 EndoTV Coupler ...43 EndoLight Source ...43 ThoraxShine ...44 VeinFinder ...44 LaryngoBlade Mac Style 1 ...44 LaryngoBlade Miller Style 0 ...45 LaryngoBlade Miller Style 00 ...45

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1 Important information Thank you very much for having confidence in our product. Acutronic Medical Systems AG manufactures its products based on years of experience and the highest technical standards. By purchasing InfantView you have opted for a unique, top-quality product from Acutronic Medical Systems AG.

1.1 Notes about the Instructions for Use Please read these Instructions for Use carefully before using InfantView; keep them in a safe place for reference.

These Instructions for Use will help you to use, clean, disinfect and sterilise InfantView properly. They are not intended as an introduction to the technique of laryngoscopy or transillumination. The topic you are looking for can easily be found by referring to the Table of Contents.

1.2 Note, caution, warning The three types of information NOTE, CAUTION and WARNING draw attention to the fact that the associated text should be read carefully in order to ensure safe use. NOTE supplements the instructions by adding information that is particularly important or relevant to operation. WARNING draws attention to a risk for patients or staff. Ignoring a warning can cause injury to patients or staff. CAUTION draws attention to a hazard that can cause damage to property or the product.

1.3 Sterility WARNING: InfantView is not sterile when it is delivered. Before it is used for the first time and before every further use, InfantView must be cleaned, disinfected and sterilised.

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1.4 Controls Main unit

ControlUnit REF 8101

Accessories

VisionHandle REF 8102

LaryngoBlade REF 8110 | REF 8109 | REF 8108

VeinFinder REF 8107

ThoraxShine REF 8106

EndoCamera Head REF 8103

EndoTV Coupler REF 8103.C

EndoLight Source REF 8104

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1.5 Approved connection combinations LIGHT

CAMERA

Connection to ControlUnit Combination Accessories

VisionHandle

---

VeinFinder

---

ThoraxShine

---

VeinFinder + VisionHandle

ThoraxShine + VisionHandle

EndoLight Source + EndoCamera Head

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1.6 Approved applications Accessories

Application

Introducing aid for intubation Visualisation of airways VisionHandle + LaryngoBlade

Illumination of veins VeinFinder

Illumination of chest ThoraxShine

with connected intubation aid: Introducing aid for intubation Visualisation of airways EndoCamera Head + EndoTV Coupler + EndoLight Source WARNING: The temperature of the light emission source on the VisionHandle can exceed 41 °C (45.8 °C max. however). Therefore never use the VisionHandle without a LaryngoBlade attached, to prevent from thermal tissue damage and coagulation. WARNING: Neither with nor without an attached LaryngoBlade may the light source in the VisionHandle be used for the illumination of veins or the chest. WARNING: The EndoLight Source must not be used for the illumination of veins or the chest.

1.7 Device-specific changes Acutronic Medical Systems AG stands for ongoing innovation and further development. That is why we reserve the right to make changes in design, features and technology. Consequently, it is not possible to file any claims based on these Instructions for Use.

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1.8 Symbols Symbol

Meaning USB port Equipotential bonding terminal

Type BF applied part WARNING/CAUTION: Comply with important warnings and precautions in the Instructions for Use NOTE: Supplements the instructions by adding information that is particularly important or relevant to operation. LED light source Pack contents

Follow the Operating Instructions Item number Serial number Marking as per Medical Devices Directive 93/42/EEC Date of manufacture Manufacturer Non-sterile

Do not dispose of as household waste

Fragile, handle with care Keep away from sources of heat

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Symbol

Meaning Keep dry / protect from moisture

This way up

Do not use hooks Do not stack

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2 Safety 2.1 Intended use InfantView is an introducing aid for intubation and it serves to visualise the airways and illuminate veins and the chest. InfantView is portable and intended for use within hospitals and health facilities and may only be used by suitably qualified staff.

2.2 User's qualification InfantView may only be used by suitably medically qualified staff who are acquainted with the techniques of intubation and transillumination. These Instructions for Use are not designed to train the user in the techniques of intubation or transillumination. They are merely intended to ensure proper use, cleaning, disinfection and sterilisation of InfantView.

2.3 Safety measures InfantView may only be used if the application complies with the recognised medical rules and procedures for intubation and transillumination.

2.4 Contraindications At present no contraindications are known that directly relate to InfantView. The use of InfantView is deemed to be contraindicated if according to a qualified user (see Section 2.2 User's qualification) it might lead to a risk for the patient, e.g. due to the patient's general state of health or if at least one of the approved applications (see Section 1.6 Approved applications) as such are contraindicated.

2.5 Device check Before use, check InfantView and all the electrical connections for function and any damage! Eliminate all defects that have a detrimental effect on safety and function. In addition, make sure all parts that come into contact with the patient or are introduced to the patient's body cannot lead to a risk for the patient. There must be no unforeseen projection of parts, no sharp corners and no rough surfaces. Mechanical stress, such as that caused by the device being dropped, can lead to damage or destruction of InfantView!

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2.6 Safety information NOTE: The use of InfantView assumes detailed knowledge of and strict compliance with these Instructions for Use. This device is only intended for the use described in Section 2.1. CAUTION: InfantView may only be operated with the accessories recommended by Acutronic Medical Systems AG. Combinations with other medical devices are only safe if they are listed accordingly in the Instructions for Use to be complied with. WARNING: The S-Video output may only be used for training and demonstration purposes. WARNING: The USB output may only be used for training and demonstration purposes. CAUTION: Only new, newly formatted, certified virus-free USB sticks may be plugged into the USB output port. WARNING: InfantView must be operated by suitably qualified staff. WARNING: At all times during the use of InfantView the user must be able to perform intubation without the ControlUnit, or have an alternative intubation system available. WARNING: InfantView must not be used in conjunction with flammable gases or anaesthetics because otherwise there may be an acute risk of fire or explosion. WARNING: Never operate InfantView in potentially explosive atmospheres. WARNING: Never use InfantView on a patient if a defect or malfunction is found during the device check. WARNING: Never operate InfantView if it is covered up or set up in such a way that its operation, performance or function is impaired. WARNING: To avoid risk of electric shock, InfantView must only be connected to a supply mains with protective earth. CAUTION: The casing must not be opened. WARNING: It is not allowed to modify the device.

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WARNING: InfantView is not sterile when it is delivered. Before it is used for the first time and before every further use, the main unit and all the accessories must be cleaned, disinfected and sterilised. CAUTION: No objects may be placed on the surfaces of InfantView, no matter whether the ControlUnit is open or closed.

When closing the ControlUnit, make sure no limbs or other objects get trapped. WARNING: Every time before using, check InfantView to make sure it is working properly. WARNING: Every time before using, check whether InfantView has been cleaned, disinfected and sterilised properly. CAUTION: Always arrange the connections in such a way that there is no tripping hazard. WARNING: Every time before using, make sure all the parts that come into contact with the patient or are introduced to the patient's body cannot lead to a risk (e.g. no unforeseen projection of parts, no sharp corners and no unintentional rough surfaces). WARNING: If InfantView is found to be obviously damaged, do not use the device under any circumstances and check whether it will be necessary to send it in for repair. WARNING: The high-power LED light can lead to high temperatures at the emitters. WARNING: All light sources constitute a dazzle hazard! Never look directly into any of the light emitters. NOTE: The device can only be disconnected from the power supply by completely unplugging the mains cable. Make sure the mains socket is always freely accessible so that you can unplug at any time. NOTE: The applied parts supplied by Acutronic Medical Systems AG for InfantView are biocompatible. NOTE: The safety and health of users is guaranteed by the fact that the products do not contain any allergenic or mutagenic substances such as phthalates, for example.

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3 Device description 3.1 Front view of the ControlUnit Folding display

Button SAVE TO USB

USB Port

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Button WIN UP

MENU Control

Button WHITE BALANCE

Button BRIGHTNESS +

Button ON/OFF

Button BRIGHTNESS -

Button WIN DOWN

Connection Socket CAMERA

Button INTENSITY +

Button INTENSITY Button Connection Socket LIGHT ON/OFF LIGHT

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3.2 Rear view of the ControlUnit Equipotential Bonding Ventilation

Fuse Holder

Mains Switch Rating Plate

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Mains Input

S-Video Output for Monitor

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4 Putting into operation 4.1 Main unit

ControlUnit (REF 8101)

Place the InfantView ControlUnit on a clean, flat surface and open the display. NOTE: Fold up the display with one hand while you hold the bottom part with your other hand. CAUTION: Make sure you maintain a minimum distance of 15 cm between the back panel and other objects Connect the equipotential bonding (EB) pin to an equipotential bonding bar using an equipotential bonding cable. Connect InfantView to the mains socket on the back panel using the mains cable supplied.

CAUTION: Check the mains connection! To do so, make sure the voltages and power figures indicated on the rating plate can be complied with.

Press the mains switch on the back panel of the device. The main unit is now ready for operation and is in standby mode. I: ON O: OFF

You can recognise standby mode from the green flashing LED of the ON/OFF button on the front panel of the device. LED flashes: standby mode

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4.2 Accessories Connecting accessories to the LIGHT/CAMERA sockets LIGHT

LIGHT socket

CAMERA

CAMERA socket

Make sure the main unit is ready for operation and in standby mode (see Section 4.1 Main unit) LED flashes: standby mode

Decide on one of the approved connection combinations (see Section 1.5 Approved connection combinations) Remove the cap from the end of the connecting cable to reveal the plug.

LIGHT

CAMERA Plug the appropriate accessory into the LIGHT socket Plug the appropriate accessory into the CAMERA socket

CAUTION: Make sure the plug is in the correct position (red dots on plug and socket) and the locking sleeve snaps into place at the front. To release the plug and the locking mechanism, pull the locking sleeve to the rear. NOTE: Make sure the plug is always completely in the socket.

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LED flashes: standby mode

Pressing the ON/OFF button switches InfantView from standby mode to operating mode. The accessories connected to the CAMERA socket and the LIGHT socket are switched off directly using the ON/OFF button.

LED lit: operating mode

LED off: LIGHT socket off

Press the LIGHT ON/OFF button to switch the accessory plugged into the LIGHT socket on and off separately NOTE: The LIGHT ON/OFF button only works if the main unit is in operating mode.

LED lit: LIGHT socket on

VisionHandle with LaryngoBlade

VisionHandle (REF 8102)

LaryngoBlade (REF 8110 | REF 8109 | REF 8108) Attaching Attaching: Put the desired LaryngoBlade on the head of the VisionHandle using a horizontal motion until it comes to a stop and snaps into place. NOTE: When attaching, make sure the LaryngoBlade is located at the stop and locked in place. The ball latch keeps the LaryngoBlade securely in position. NOTE: The LaryngoBlade is provided with a specific InfantView coupling that optimally locks the lens system of the LaryngoBlade onto the VisionHandle.

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Detaching Detaching: Pull the LaryngoBlade back out of the head of the VisionHandle again using a horizontal motion.

CAMERA The VisionHandle has to be plugged into the CAMERA socket.

Switch the main unit from standby mode to operating mode using the ON/OFF button. The VisionHandle switches on automatically. NOTE: The LED light integrated into the VisionHandle is simultaneously connected when the cable is plugged in. No additional connection is required. The video laryngoscope is now ready for operation.

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VeinFinder

VeinFinder (REF 8107)

LIGHT The VeinFinder has to be plugged into the LIGHT socket.

Switch the main unit from standby mode to operating mode using the ON/OFF button. The VeinFinder switches on automatically. The VeinFinder can be switched on and off separately using the LIGHT ON/OFF button. NOTE: The LIGHT ON/OFF button only works if the unit is in operating mode. The VeinFinder is now ready for operation.

ThoraxShine

ThoraxShine (REF 8106)

LIGHT The ThoraxShine has to be plugged into the LIGHT socket.

Switch the main unit from standby mode to operating mode using the ON/OFF button. The ThoraxShine switches on automatically. The ThoraxShine can be switched on and off separately using the LIGHT ON/OFF button. NOTE: The LIGHT ON/OFF button only works if the unit is in operating mode. The ThoraxShine is now ready for operation.

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