aScope 3 Family Instructions for Use Ver 06

Instructions for Use

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File Name: Ambu - 492 4030 00 - aScope 3 Family Instructions for Use Ver 06 June 2016 - 2016-06.pdf

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Instructions for use Ambu® aScope™ 3 Family

Ambu® aView™

For use by trained clinicians/physicians only. For in-hospital use.

Contents

Page

1. Important information – read before use... 5 2. System Parts... 6 3. aScope 3 System Usage... 11 4. Cleaning and Disinfection of aView... 14 5. Technical Product Specifications... 15 5.1. aScope 3 Specifications... 15 6. Use of aView and connecting accessories... 17 7. How to operate aView part no. 405001000... 19 8. How to Operate aView part no. 405002000... 26 9. Trouble Shooting... 37 Appendix 1: Electromagnetic Compatibility... 39 Appendix 2. Standards Applied... 40 Appendix 3. Warranty and Replacement Program... 41 Appendix 4. Material lists for aView and aScope 3... 41

1. Important information – read before use NOTE Read these safety instructions carefully before using the aScope 3 system. The Instructions for use may be updated without further notice. Copies of the current version are available upon request.

WARNING - aScope 3 is a single-use device and must be handled in a manner consistent with accepted medical practice for such devices in order to avoid contamination of the aScope 3 prior to insertion. - aScope 3 images must not be used as an independent diagnostic of any pathology. Physicians must interpret and substantiate any finding by other means and in the light of the patient's clinical characteristics.

1.1. Instructions Please be aware that these instructions do not explain or discuss clinical procedures. They describe only the basic operation and precautions related to the operation of the aScope 3 system. Before initial use of the aScope 3 system, it is essential for operators to have received sufficient training in clinical endoscopic techniques and to be familiar with the intended use, warnings, cautions, notes, indications and contraindications mentioned in these instructions.

1.2. Intended use The aScope 3 endoscopes have been designed to be used with the aView monitor, endotherapy accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree.

1.3. Indications for use The aScope 3 system is for use in a hospital environment. The aScope 3 is a single-use device designed for use in adults. It has been clinically evaluated for the following minimum endotracheal tubes (ETT) and double lumen tubes (DLT) sizes: Minimum ETT inner diameter

Minimum DLT size

aScope 3 Slim 3.8/1.2

5.0 mm

37 Fr

aScope 3 Regular 5.0/2.2*

6.0 mm

41 Fr

*aScope 3 Regular 5.0/2.2 is identical to aScope 3 5.0/2.2 Endoscopic accessories designed for a minimum working channel width up to 1,2 mm can be used with the aScope 3 Slim 3.8/1.2. Endoscopic accessories designed for a minimum working channel width up to 2.0 mm can be used with the aScope 3 Regular 5.0/2.2. There is no guarantee that instruments selected solely using this minimum instrument channel width will be compatible in combination.

WARNING Do not use active endoscopic accessories such as laser probes and electrosurgical equipment in conjunction with the aScope 3 system, as this may result in patient injury or damage to aScope 3 system.

1.4. Warnings, Cautions and Notes Throughout these instructions, appropriate warnings, cautions and notes are given describing potential safety hazards associated with the use of the aScope 3 system. The information given in these instructions serves only to instruct in the correct handling of the system. Throughout these instructions, the following definitions are used:

WARNING Alerts the user to the possibility of injury, death, or other serious adverse reactions associated with the use or misuse of the aScope 3 system.

CAUTION Alerts the user to the possibility of a problem with the aScope 3 system associated with its use or misuse. Such problems include aScope 3 system malfunction, aScope 3 system failure, damage to the aScope 3 system or damage to other property.

NOTE Advises owner/operator about important information on the use of this equipment.

GENERAL WARNINGS - Do not use the aScope 3 system if it is damaged in any way. - Perform a functional check before using the aScope 3 system (see section 3.1). Do not use the aScope 3 system if any part of the functional check fails. - Do not attempt to clean and reuse the aScope 3 as it is a single-use device. Reuse of the product can cause contamination, leading to infections. - The aScope 3 system is not to be used when delivering highly flammable anaesthetic gases to the patient. This could potentially cause patient injury. - The aScope 3 system is neither MRI safe nor MRI compatible. - Do not use the aScope 3 system during defibrillation. - When handling the patient do not simultaneously touch the aView power socket or docking connector. - Only to be used by skilled physicians trained in clinical endoscopic techniques and procedures. - Excessive force should never be used when operating aScope 3. - Patients should be adequately monitored at all times during use. - Always watch the live endoscopic image on the aView when advancing or withdrawing the scope 3, operating the bending section or suctioning. Failure to do so may harm the patient. - The aScope 3 system may cause interference or disrupt equipment operations nearby. It may be necessary to adopt procedures for mitigation, such as reorientation or relocation of the equipment or shielding of the room in which it is used.

GENERAL CAUTION - Be careful not to damage the insertion cord or distal tip when using sharp devices such as needles in combination with the aScope 3. - Be careful when handling the distal tip of the insertion cord and do not allow it to strike other objects, as this may result in damage to the equipment. The lens surface of the distal tip is fragile and visual distortion may occur. - Do not exert excessive force on the bending section as this may result in damage to the equipment. Examples of inappropriate handling of the bending section include: - Manual twisting. - Operating it inside an ETT or in any other case where resistance is felt. - Inserting it into a preshaped tube or a tracheostomy tube with the bending direction not aligned with the curve of the tube. - US federal law restricts these devices for sale only by, or on the order of, a physician. - Keep the aScope 3 handle and the aView dry during preparation, use and storage. - The batteries in aView are not changeable and must only be removed upon disposal. - Portable electronic equipment may affect the normal function of the aScope 3 system

GENERAL NOTES Have a suitable backup system readily available for immediate use so the procedure can be continued if a malfunction should occur. Ambu is not responsible for any damage to the system or patient resulting from incorrect use.

2. System Parts CAUTION The aScope 3 system consists of the parts described in section 2. They may only be replaced by Ambu authorized parts. Failure to comply with this may reduce safety and efficiency.

2.1. System Parts Before you install and use the system please ensure that the following items are available: Ambu® aScope™ 3 – Single use device: Ambu® aScope™ 3

Part numbers:

Instructions for use

403001000 aScope 3 Regular 5.0/2.2 402001000 aScope 3 Slim 3.8/1.2

Part numbers: 492403000

Instruction for use

Ambu® aScope™ 3 Single Use Flexible Videoscope

60 cm/23.6" 492403000 V01

Ambu® aScope™ 3 Slim 3.8/1.2 & Ambu® aScope™ 3 Regular 5.0/2.2 are not available in all countries. Please contact your local sales office.

Ambu® aView™ – Reusable device: Ambu® aView™

Part numbers:

Bracket

(e.g. for attaching the aView to an I.V. pole)

405001000 Model no. JANUS-W08-R10 (SW versions v1.XX) 405002000 Model no. JANUS2-W08-R10 (SW versions v2.XX)

Part numbers: 401000711

For aView model no., please check backside label on aView. Ambu® aView™ is not available in all countries. Please contact your local sales office. Power supplies

Part numbers:

aView power supply manufacturer: FSP Group Inc. aView power supply part number: FSP030-REAM

Accessories

EU/CH 405014700X (not DK & UK) UK 405013700X DK 405012700X AUS & NZ 405015700X US 405016700X Part numbers:

aView adaptor cable for composite connection

405000712

2.2. Description of the aScope 3 system The aScope 3 system consists of the aScope 3 and the aView. To avoid risk of cross-contamination the aScope 3 is a sterile single use device. The aView is reusable. There are 2 different variants of the aScope 3: aScope 3 Regular 5.0/2.2 and aScope 3 Slim 3.8/1.2 Product Name

Differentiation

aScope 3 Regular 5.0/2.2

OD min 5.0 mm max 5.5 mm ID min 2.0 mm Green control lever and tube connection

aScope 3 Slim 3.8/1.2

OD min 3.8 mm max 4.2 mm ID min 1.2 mm Grey control lever and tube connection

Unless specified otherwise, the text relates to all products. In this document the term "aScope 3" always refers to all variants. If one of the variants is referred to specifically, the terms "aScope 3 Regular 5.0/2.2 " or "aScope 3 Slim 3.8/1.2" is used respectively.

aScope 3

Control lever Moves the distal tip up or down in a single plane

Working channel port Allows for instillation of fluids and insertion of endoscopic accessories

Tube connection Allows for fixation of tubes with standard connector during procedure

Suction button Activates suction when pressed

Handle protection Protects the suction connector during transport and storage. Remove before use.

aScope 3 cable Transmits the image signal to aView

Suction connector Allows for connection of suction tubing

Handle Suitable for left or right hand

Insertion cord Flexible airway insertion cord

Connector on aScope 3 cable Connects to blue socket on aView

Bending section Manoeuvrable part

Distal end Contains the camera, light source (two LEDs), as well as the working channel exit

Introducer To facilitate introduction of Luer Lock syringes and soft endoscopic accessories through working channel

Protection pipe Protects the insertion cord during transport and storage. Remove before use.

aView The aView displays the video image from the aScope 3. During start up, aView powers up and configures the aScope 3. Monitor Casing

Blue socket For the aScope 3 cable. Protected by a rubber cover Stand To place the aView on a solid surface.

Touch Screen Displays the image from the camera and a touch screen interface.

Power supply Powers the system and charges the battery. Power cord with country-specific plug

Input/output connections Composite interface and USB interface

ON/OFF button Push button for power ON before procedure and power OFF after procedure.

Power Power socket for charging aView. Protected by a rubber cover Docking connector (for future use)

Bracket Secures the monitor to e.g. an IV pole

Pouch hook Slide the hook through the 3 holes on the bracket. It can now be used to hold the aScope 3 pouch (hole in top corner) for easy storage before and during use.

Hexagonal key To tighten the bolt on the bracket

Adapter cable for the composite video-out interface

2.3. Explanation of symbols used Symbols for the aScope 3 devices

60 cm/23.6"

Indication Working length of the aScope 3 insertion cord.

Max OD

Maximum insertion portion width (Maximum outer diameter).

Min ID

Minimum working channel width (Minimum inner diameter).

Field of view.

Do not use if the product sterilisation barrier or its packaging is damaged. This product is not made with natural rubber latex.

Connection for the aScope 3 devices.

Electrical Safety Type BF Applied Part.

Use By, followed by YYYY-MM-DD.

Sterile Product, Sterilisation by ETO.

Single use product, do not reuse. Symbols for the aView

Indication Lights up when visualization device is connected. The icon colour will match the colour of the interface used.

Max. battery status of the aView

Min. battery status of the aView

Fully charged battery still connected to charger

The icon remains white until one block is left, after which it turns red. When remaining battery capacity is 10% the red battery icon starts flashing.

Battery is charging

Battery current capacity

Battery damaged

Charging is shown with blocks flashing. Current capacity is shown with non-flashing blocks. Standby button for aView. The button will light up green when turned ON and not charging (power adaptor not connected to mains) and orange when charging (power adaptor connected to mains).

Humidity limitation: relative humidity between 30 and 85% in operating environment.

Atmospheric pressure limitation: between 80 and 109 kPa in operating environment

Connection to external monitor.

Direct current. Alternating current. IP30

Protection against solid objects.

Waste Bin symbol, indicating that waste must be collected according to local regulation and collection schemes for disposal of batteries. Only applicable for the battery inside the aView.

Waste Bin symbol, indicating that waste must be collected according to local regulation and collection schemes for disposal of electronic and electrical waste (WEEE). Only applicable for the aView.

Li-ion

Battery type Lithium ion. Only applicable for the battery inside the aView. Re-chargeable battery. Only applicable for the battery inside the aView

Tested to comply with FCC Standards - Medical Equipment. MEDICAL - GENERAL MEDICAL EQUIPMENT AS TO ELECTRICAL SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH ANSI/AAMI ES60601-1:2005/(R):2012 CAN/CSA-C22.2 No. 60601-1:08 (R2013) IEC 60601-2-18:2009 UL60601-1, 1st ed.: 2006 CAN/CSA-C22.2 No. 601.1-M90, 2005 IEC 60601-2-18:1996 Control no 4UD1. Only applicable for aView UL Recognized Component Mark for Canada and the United States. Only applicable for aScope 3. Symbols covering both aScope 3 and aView

Indication Manufacturer. Only for indoor use. CE mark. The product complies with the EU Council directive concerning Medical Devices 93/42/EEC Reference Number. Lot Number, Batch Code. Serial Number. Warning. Consult Instruction for use. Date of Manufacture, followed by YYYY-MM-DD.

3. aScope 3 System Usage NOTE Have a suitable backup system readily available for immediate use so the procedure can be continued if a malfunction should occur.

3.1. Preparation and Inspection WARNING Do not use the aScope 3 system if it is damaged in any way or if any part of the functional check described below fails.

CAUTION The aScope 3 system consists of the parts described in section 2. They may only be replaced by Ambu authorised parts. Failure to comply with this may reduce safety and efficiency. Visual inspection of the aScope 3 1. Check that the pouch seal is intact.

WARNING • Do not use aScope 3 if the product sterilisation barrier or its packaging is damaged. • Do not use a knife or other sharp instrument to open the pouch or cardboard box. 2. Make sure to remove the protective elements from the handle and from the insertion cord. 3. Check that there are no impurities on the product. 4. Check that there is no evidence of shipping damage or other damage such as rough surfaces, sharp edges or protrusions which may harm the patient. Visual inspection and preparation of the aView

CAUTION • Pay attention to the battery symbol indicator on the aView monitor. Recharge aView when the battery level is low (see section 6.1). • It is recommended that aView is recharged before every procedure and that a charger be readily available during use. • Place or hang the aView display on a stable support while in use. Dropping aView could damage it. • Position the power cord where it is unlikely to be stepped on. Do not place any objects on the power cord. • If the aScope 3 system is used adjacent to or stacked with other equipment, observe and verify normal operation of the aScope 3 system prior to using it. Consult the tables in Appendix 1 for guidance in placing the aScope 3 system. 1. 2. 3. 4. 5. 6. 7.

Check for any damage to the aView cable and power supply (free from wear and tear). Closely examine the aView for any damage. Switch the aView on by pressing the on/off button. Check the battery indicator on the aView. If the time remaining is not sufficient for the procedure – charge the aView. Be sure the power supply is present and working at any time. It is recommended to locate the nearest wall socket before start of the procedure. For instructions on how to use the aView with the mounting bracket, please refer to chapter 6.

Inspection of the Image 1. Connect aScope 3 to the aView by plugging the white aScope 3 connector with blue arrow into the corresponding blue female connector on the aView. Please ensure when inserting the aScope 3 connector into the aView connector that the blue arrow is facing towards you in line with the screen as shown on the picture. 2. Verify that a live video image appears on the screen. 3. Point the distal end of aScope 3 towards an object, e.g. the palm of your hand. 4. Adjust the image preferences on the aView if necessary – please refer to chapter 7 or 8 for details. 5. If the object cannot be seen clearly, wipe the lens at the distal end using a sterile cloth.

Preparation of aScope 3 1. Carefully slide the bending control lever forwards and backwards in each direction until it stops. Confirm that the bending section functions smoothly and correctly. 2. Slide the bending lever slowly to its neutral position. Confirm that the bending section returns smoothly to a neutral position. 3. Using a syringe insert 2ml of sterile water into the working channel port (if Luer Lock syringe use the enclosed introducer). Depress the plunger, ensure there are no leaks, and that water is emitted from the distal end. 4. If it is anticipated that suction will be required during the procedure, prepare the suction equipment according to the supplier’s manual. Connect the suctioning tube to the suction connector and press the suction button to check that suction is applied. 5. If applicable, verify that endoscopic accessory of appropriate size can be passed through the working channel without resistance. The enclosed introducer can be used to facilitate the insertion of soft accessories such as microbiology brushes.

3.2. Operating the aScope 3 WARNING • Excessive force should never be used when operating aScope 3. • If any malfunction should occur during the endoscopic procedure, stop the procedure immediately, put the distal tip in its neutral and non-angled position and slowly withdraw the aScope 3 without touching the bending lever. • Always observe the live endoscopic image while withdrawing the aScope 3. • If needed remove secretion or blood from the airway before and during the procedure. The suction function of any appropriate suction device can be used for this purpose. • The distal end of the endoscope may get warm due to heating from the light emission part. Avoid long periods of contact between the tip of the device and the mucosal membrane as long, sustained contact with the mucosal membrane may cause mucosal injury. Holding the aScope 3 The handle of the aScope 3 can be held in either hand. Use the thumb to move the control lever and the index finger to operate the suction button. The hand that is not holding the aScope 3 can be used to advance the insertion cord into the patient’s mouth or nose.

Manipulating the tip of the aScope 3 The control lever is used to flex and extend the tip of the aScope 3 in the vertical plan. Moving the control lever downward will make the tip bend anteriorly (flexion). Moving it upward will make the tip bend posteriorly (extension). The insertion cord should be held as straight as possible at all times in order to secure an optimal tip bending angle.

CAUTION Do not exert excessive force on the bending section as this may result in damage to the equipment. Examples of inappropriate handling of the bending section include: - Manual twisting. - Operating it inside an ETT or in any other case where resistance is felt. - Inserting it into a preshaped tube or a tracheostomy tube with the bending direction not aligned with the curve of the tube.

Tube connection The tube connection can be used to mount ETT and DLT with an ISO connector during intubation.

Insertion of the aScope 3

CAUTION When inserting the aScope 3 orally, it is recommended to use a mouthpiece to protect the aScope 3 from being damaged. Lubricate the insertion cord with a medical grade lubricant to ensure the lowest possible friction when the aScope 3 is inserted into the patient. If the camera image of the aScope 3 becomes unclear the tip can be cleaned by gently rubbing the tip against the mucosal wall or remove the aScope 3 and clean the tip with a piece of sterile gauze or a hospital disinfection wipe. Continue the procedure until a satisfactory image is obtained. Instillation of fluids Fluids can be instilled through the working channel by inserting a syringe into the working channel port at the top of the aScope 3. When using a Luer Lock syringe, use the included introducer. Insert the syringe completely into the working channel port or the introducer before instilling fluid. Failure to do so may result in the fluid spilling from the working channel port. Press the plunger to instill fluid. Make sure you do not apply suction during this process, as this will direct the instilled fluids into the suction collection system. To ensure that all fluid has left the channel, flush the channel with 2ml of air. Aspiration When a suction system is connected to the suction connector, suction can be applied by pressing the suction button with the index finger.

WARNING • Always make sure that any tube connected to the suction connector is connected to a suction device. • Apply a vacuum of 85 kPa (638 mmHg) or less when suctioning. Applying too large a vacuum may make it difficult to terminate suctioning.

CAUTION Secure the tubing properly on the suction connector before suction is applied. If the introducer and/or an endoscopic accessory is placed inside the working channel note that the suction capability will be reduced. For optimal suction capability it is recommended to remove the introducer or syringe entirely during suction. Insertion of endoscopic accessories

WARNING • Do not use active endoscopic accessories such as laser probes and electrosurgical equipment in conjunction with the aScope 3 system, as this may result in patient injury or damage to aScope 3. • Do not advance or withdraw aScope 3, or operate the bending section, while endoscopic accessories are protruding from the distal end of the working channel, as this may result in injury to the patient.

CAUTION • Always make sure that the bending section is in a straight position when inserting or withdrawing an endoscopic accessory in the working channel. Never use excessive force when advancing or withdrawing an endoscopic accessory inside the working channel. Failure to observe the above may result in damage to the working channel. Always make sure to select the correct size endoscopic accessory for the aScope 3 (See section 1.3). Inspect the endoscopic accessory before using it. If there is any irregularity in its operation or external appearance, replace it. Insert the endoscopic accessory into the working channel port and advance it carefully through the working channel until it can be seen on the aView. The enclosed introducer can be used to facilitate the insertion of soft accessories such as microbiology brushes.

Withdrawal of the aScope 3

WARNING While withdrawing the aScope 3, the distal tip must be in a neutral and non-deflected position. Do not operate the bending lever, as this may result in injury to the patient and/or damage to the aScope 3. When withdrawing the aScope 3, make sure that the control lever is in the neutral position. Slowly withdraw the aScope 3 while watching the live image on aView.

3.3. After Use WARNING • Do not attempt to clean and reuse the aScope 3 as it is a single-use device. Reuse of the product can cause contamination, leading to infections. • Always perform a visual check according to the instructions in this section before placing the aScope 3 in a waste container. Visual check 1. Are there any missing parts on the bending section, lens, or insertion cord? If yes, then take corrective action to locate the missing part. 2. Is there any evidence of damage on the bending section, lens, or insertion cord? If yes, then examine the integrity of the product and conclude if there are any missing parts. 3. Are there cuts, holes, sagging, swelling or other irregularities on the bending section, lens, or insertion cord? If yes, then examine the product to conclude if there are any missing parts. In case of corrective actions needed (step 1 to 3) act according to local hospital procedures. The elements of the insertion cord are radio opaque. Final steps Disconnect the aScope 3 from the aView and dispose of the aScope 3 in accordance with local guidelines for collection of infected medical devices with electronic components. Switch off aView by pressing the power button for at least 2 seconds. The aScope 3 is a single use device. The aScope 3 is considered infected after use and must be disposed of in accordance with local guidelines for collection of infected medical devices with electronic components. Do not soak rinse, or sterilize this device as these procedures may leave harmful residues or cause malfunction of the device. The design and material used are not compatible with conventional cleaning and sterilization procedures At the end of product life open up the aView and remove the batteries. Dispose of the batteries and aView separately in accordance with local guidelines.

WARNING Clean and disinfect the aView monitor after each use according to the instructions in section 4.

4. Cleaning and Disinfection of aView The aView should be cleaned and disinfected before and after each use. It is recommended that the aView be cleaned and disinfected before and after use following the instructions below. Ambu has validated these instructions in accordance with AAMI TIR 12 & 30. Any deviation from the instructions should be properly evaluated for effectiveness and potential adverse consequences by the reprocessor, to ensure that the device continues to fulfil its intended purpose.

WARNING • Disconnect aView from any mains power supply, remove any accessories and make sure the aView is completely turned off before cleaning and disinfection. • To disconnect aView from mains remove the mains plug from the wall outlet.

4.1. Cleaning Clean the aView according to good medical practice using the below procedure: 1. Prepare a cleaning solution using a standard enzymatic detergent prepared per manufacturers recommendations. Recommended detergent: enzymatic, mild pH: 7-9, low foaming (Enzol or equivalent). 2. Soak a sterile gauze in the enzymatic solution and make sure that the gauze is moist and not dripping. 3. Thoroughly clean the button, rubber covers, screen, external casing of the monitor and stand with the moist gauze. Avoid getting the device wet to prevent damaging internal electronic components. 4. Using a sterile soft bristled brush that has been dipped in the enzymatic solution, brush the button until all evidence of soil is removed. 5. Wait for 10 minutes (or the time recommended by the manufacturer of the detergent) to allow the enzymes to activate. 6. Wipe the aView clean using sterile gauze that has been moistened with RO/DI water. Ensure all traces of the detergent are removed. 7. Repeat steps 1 to 6.

4.2. Disinfection Wipe the surfaces of aView for approximately 15 minutes using a piece of sterile gauze moistened with the alcohol mixture indicated below (approximately once every 2 minutes). Follow safety procedures for the handling of isopropyl. The gauze should be moist and not dripping since liquid can affect the electronics inside the aView. Pay close attention to the button, rubber covers, screen, external casing and stand, slots and gaps on the aView. Use a sterile cotton swab for these areas. Solution

Concentration

Preparation

Isopropyl (alcohol) 95%

70-80%

80cc of 95% Isopropyl (alcohol) added to 20cc of purified water (PURW)*

*Alternatively, use EPA-registered hospital disinfection wipes containing at least 70% isopropyl. Safety precautions and directions of use of the manufacturer must be followed. After cleaning and disinfection, the aView must be submitted to the pre-check procedure in section 3.1. Between procedures, aView must be stored in accordance with local guidelines.

5. Technical Product Specifications 5.1. aScope 3 Specifications aScope 3 Slim

aScope 3 Regular

Field of View

85°

Depth of Field

8-19 mm

Illumination method

LED

Bending section3

130° up, 130° down

150° up, 130° down

Insertion cord diameter

3.8 mm (0.15”)

5.0 mm (0.20”)

Distal end diameter

4.2 mm (0.16”)

5.4 mm (0.21”)

Maximum diameter of insertion portion

4.3 mm (0.17”)

5.5 mm (0.22”)

Minimum endotracheal tube size (inner diameter)

5.0 mm

6.0 mm

Minimum double lumen tube size (inner diameter)

37 Fr

41 Fr

Working length

600 mm (23.6”)

1.2 mm (0.047”)

2.0 mm (0.079”)

Ø7 mm +/- 1mm

Temperature

10 ~ 40°C (50 ~ 104°F)

Relative humidity

30 ~ 85%

Atmospheric pressure

80 ~ 109 kPa

Altitude

≤ 2000 m

10 ~ 40°C (50 ~ 104°F)

10 ~ 25°C (50 ~ 77°F)

Relative humidity

30 ~ 85%

Atmospheric pressure

80 ~ 109 kPa

EtO

Optical System

Insertion portion

Channel Minimum instrument channel width4

Suction connector Connecting tube inner diameter

Operating environment

Storage and transportation Transportation temperature Recommended storage temperature

Sterilisation Method of sterilisation 3 Please be aware that the bending angle can be affected if the insertion cord is not kept straight 4 There is no guarantee that accessories selected solely using this minimum instrument channel width will be compatible in combination. 5 Storage under higher temperatures may impact shelf life.

5.2. aView Specifications Display Max. resolution

800 * 480

Orientation

Landscape

Display type

8.5” colour TFT LCD

Brightness control

Yes, (“+” / ”-“)

Contrast control

Yes, (“+” / ”-“)

Start up time

About 1 second

Memory Storage capacity

8GB

Electrical power Power requirement

18V 1.67A DC input

Battery type

11.1V 3760mAh (part no. 405001000) 10.8V 4300mAh (part no. 405002000)

Battery Operation

Typical battery runtime of a new, fully charged battery (aView turned on and scope connected) is min. 3 hours

Protection against electrical shock

Internally Powered

Operating environment Temperature

10 ~ 40°C (50 ~ 104°F)

Relative humidity

30 ~ 85%

IP Protection Classification System

The aView is classified IP30.

Atmospheric pressure

80-109 kPa

Altitude

≤ 2000 m

Dimensions Width

241 mm (9.49")

Height

175 mm (6.89")

Thickness

33.5 mm (1.32")

Weight

1500 g (331lbs)

Connections USB connection

Type A

Analog composite video out

RCA connection (use adapter cable included)

Storage and transportation Temperature

10 ~ 40°C (50 ~ 104°F)

Relative humidity

30 ~ 85%

Atmospheric pressure

80-109 kPa

Mounting interface Mounting interface standard

VESA MIS-D, 75 C, VESA FDMI compliant display, Part D, with centre located mounting interface

Fixture Mounting interface

75 mm (2.96”)

Fits poles with thicknesses

10 mm ~ 45 mm (0.4 ~ 1.8”)

aView power supply Weight

360g (0.79 lbs)

Electrical power Power requirement

100 - 240V AC; 50-60Hz; 0.6A

Power out

18V DC; 1.67A

Protection against electrical shock

Class I

Operating environment Temperature

10 ~ 40° C (50 ~ 104° F)

Storage Temperature

10 ~ 40°C (50 ~ 104°F)

Relative humidity

10 ~ 90%

Plugs Between the power supply and aView

Ø5.5mm DC jack connector

6 interchangeable types

1) Model NEMA 5 AC grounded power plug 2) Australian configuration: AS3112, AC grounded power plug 3) UK configuration: BS1363, AC grounded power plug 4) European configuration: CEE 7, AC grounded power plug 5) Danish configuration: 2-5a, AC grounded power plug 6) Swiss configuration: Type J, AC grounded power plug

WARNING To avoid risk of electric shock, this equipment must only be connected to a supply mains with protective earth. The equipment is disconnected from mains by removing the mains plug from the wall outlet.

6. Use of aView and connecting accessories CAUTION • The aScope 3 system consists of the parts described in section 2. They may only be replaced by Ambu authorized parts. Failure to comply with this may reduce safety and efficiency. • The aView is not intended to be repaired. If defect the aView shall be discarded. • No modification of this equipment is allowed. aView can be placed on a solid flat surface by using the stand on the back of aView. If needed, aView can be placed by using the supplied bracket.

6.1. Charging aView Connect the aView power supply to the wall socket and insert the power plug into the power inlet of the aView.

aView power button will light orange during charging. The battery icon will change as shown here: Max. battery status of the aView

Min. battery status of the aView

The icon remains white until one block is left, after which it turns red. When remaining battery capacity is 10% the red battery icon starts flashing.

Battery is charging

Battery current capacity

Charging is shown with blocks flashing Current capacity is shown with non-flashing blocks.

If the battery is fully charged and still connected to a charger the battery icon changes to:

6.2. Maintenance of battery To prolong battery life it is recommended to fully charge the monitor at least every third month and store it in a cool place. If the battery is flat the procedure can take up to 5 hours. The battery should be charged at temperatures between 10 - 40°C.

6.3. Mounting of the bracket to the aView It is recommended to use the bracket supplied. The bracket is mounted on a pole by tightening the wing nut and the aView can then be placed on the bracket. To adjust the position of the aView horizontally, loosen the wing nut and the bracket can be repositioned. To adjust the position of the aView vertically, it can be moved up and down and will stay in the position chosen. Occasionally it may be necessary to tighten the screw on the side of the bracket. This is done with the hexagonal key supplied with the aView. The maximum allowed weight on the bracket must not exceed the weight of one aView and one aScope 3.

6.4. Connection to external screen (only for part no. 405002000) The image from an Ambu Visualization device can be viewed on an external monitor using the video out interface on aView. Connect the external monitor to the composite interface on the right side of aView using the adaptor cable supplied. Please consult the manual of the external monitor for further information on how to connect an external video source by composite. See section 8 for ‘How to enable video out’ on aView (only for part no. 405002000).

7. How to operate aView part no. 405001000 7.1. How to operate aView aView only has one physical button located on the top for power ON and OFF. All other functions are operated using the User Interface controlled from the front touch screen panel.

How to turn ON aView (Assumption: aView is powered down)

on top of the aView for at least one second. Press power button - The power button will light up orange for 2 seconds - The power button will stay lit and orange if aView is charging or change to green and stay lit green if not charging. - aView is now in STARTUP IMAGE MODE. - A live image will appear within 1-2 seconds if a Ambu Visualization Device is connected or a blue screen will appear. - After about one minute, aView will be ready in Simple Mode. - A white hourglass indicating that aView is loading the User Interface will appear on the screen.

NOTE: During startup the screen may flicker for about a second. How to turn OFF aView (Assumption: aView is powered ON)

Press the power button on top of the aView for at least two seconds. The light of power button goes off if not charging or stays lit orange if charging. - A blue hourglass indicating that aView is powering down will appear on the screen and aView will power down.

7.2. MODES in aView aView has 3 modes of operation: STARTUP IMAGE MODE - Live image available while aView is loading. When the User Interface is loaded aView automatically initiates SIMPLE MODE. SIMPLE MODE - Live image available and the User Interface displays basic user functions. Advanced functions can be initiated from SIMPLE MODE by pressing ADVANCED MODE button aView loads the User Interface for ADVANCED MODE.

ADVANCED MODE - Live image available and the User Interface displays advanced user functions. - Viewing and recording live image. - aView starts up in the Blue tab for Live Image Startup Image Mode STARTUP IMAGE MODE starts one second after the ON/OFF button is pressed and continues until the User Interface is loaded. - Live image from a plugged in Ambu Visualization Device is available.

NOTE: The white hourglass to the right of the live image indicates that the aView is loading the User Interface.

Simple Mode SIMPLE MODE starts automatically once the aView User Interface is loaded. - Live image from a plugged in Ambu Visualization Devices is available. Further functions available are battery status, brightness/contrast control and possibility of displaying device usage time for the connected device.

NOTE: Press

to enter ADVANCED MODE

Advanced Mode In SIMPLE MODE press

to enter ADVANCED MODE.

ADVANCED MODE has 3 tabs with different functions . Blue tab for Live Image

- Viewing and recording live image.

Yellow tab for File Management Green tab for Settings

- Managing saved files.

- System settings.

- To change between the tabs press the tab.

NOTE: Press the RETURN SIMPLE MODE

Blue tab for Live Image

to enter SIMPLE MODE.

ADVANCED MODE starts in the blue Live Image tab

- Live image from a plugged in Ambu Visualization Devices is available. Further functions available are recording, battery status, brightness/contrast control and possibility of displaying device usage time for the connected device.

CAUTION: Be careful to check whether the image on the screen is a live image or a recorded image. NOTE: When de-selecting a live image by leaving the blue Live Image tab to go to an other tab in ADVANCED MODE, aView asks for confirmation. Live image vs. recorded image in ADVANCED MODE When exiting a live image by leaving the blue Live Image tab to go to another tab in ADVANCED MODE, aView asks for confirmation before removing the live image. To distinguish between a live image and a recorded image the button´s shape and colour changes .

when leaving the blue Live Image tab

Round BLUE buttons are shown in the blue Live Image tab

and indicates a live image.

Square YELLOW or GREEN buttons are shown the yellow File Management tab Settings tab

and the green

and indicates a recorded image.

Yellow tab for File Management Press the yellow File Management tab

: to view, delete, rename or transfer recorded files.

NOTE: Press the blue Live Image tab or RETURN SIMPLE MODE from a connected Ambu Visualization Device with just one click.

to view a live image

Green tab for Settings

Press the green Settings tab

to setup system settings and upgrade software.

NOTE: Press the blue Live Image tab or RETURN SIMPLE MODE from a connected Ambu Visualization Device with just one click. How to view a live image (Assumption: aView is powered off and the Ambu Visualization Device is connected)

Press the power button

to view a live image

on top of the aView for at least one second.

STARTUP IMAGE MODE is initiated showing the live image within 1-2 seconds. The white hourglass is shown to the right to indicate that User Interface is loading. SIMPLE MODE is automatically entered when the User Interface is loaded and the User Interface is shown to the right of the live image. to enter ADVANCED MODE and the blue Live Image tab Press the live image shown.

NOTE: Press How to adjust brightness and contrast

will be entered and

in ADVANCED MODE to see the live image.

the up arrow to increase brightness and the down arrow to decrease brightness. Press - The arrow will light up red when pressed and the level attained will be shown for a few seconds instead of the brightness icon.

the up arrow to increase contrast and the down arrow to decrease contrast. Press - The arrow will light up red when pressed and the level attained will be shown for a few seconds instead of the contrast icon. (Accessible from SIMPLE MODE and ADVANCED MODE)

How to view Device Usage Time

(Accessible from SIMPLE MODE and ADVANCED MODE indicator bar)

NOTE: Contrast can only be changed on a live image. to view the total time the Ambu Visualization Device connected has been turned on. Press - Usage time is displayed for 2 seconds and then disappears automatically.

NOTE: The device icon will be in the colour of the device interface where the Ambu Visualization Device is connected.

How to take a SNAPSHOT

Keep the Ambu Visualization device as still as possible when taking a snapshot to prevent blurring of the picture. to take snapshot. - Press - The button turns red while the file is saved and then returns to blue.

(Accessible in ADVANCED MODE ) – blue Live Image tab

How to record a VIDEO

NOTE: The snapshot is saved automatically in the folder for the device. See section ‘Placement of files’ for file placement. Press

to start recording video.

- The button turns red while recording. - The recorded time is shown. Press

to stop recording video.

- The button turns back to blue. (Accessible in ADVANCED MODE ) – Blue Live Image tab

How to locate recorded files and folders (Accessible from ADVANCED MODE – File Management tab

NOTE: The video is saved automatically in the folder for the device. See section ‘Placement of files’ for file placement. Press the yellow File Management tab to access the file structure. (For file placement see section ‘Placement of files’) once to select. Press a folder - The folder icon will appear open Press

when selected.

to view the contents of the folder .

- Files are shown as in chronological order. - Press

to go up in the file structure.

- Press

to see more content in current folder.

- Repeat until the desired file or folder is located.

NOTE: The location in the folder structure is shown in the top bar. How to view snapshot

Press the snapshot to select. Press - Press

(Assumption: Snapshot has already been located.)

How to view a video

to toggle between snapshots in the folder.

NOTE: Double click to Select and View. Press the video file to select. Press

(Assumption: Video has already been located.)

to view the snapshot.

to view the file.

- Press

to jump 10 seconds backward or forward in the video

- Press

to pause video

NOTE: Double click to Select and View.

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Ambu

Flexible Intubation Scope

aScope 3 Family Instructions for Use Ver 06