aScope 2 and aScope Monitor Instructions for Use Ver 05

Instructions for Use

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File Name: Ambu - 492 8101 00-V05 - aScope 2 and aScope Monitor Instructions for Use Ver 05 Jan 2014 - 2014-01.pdf

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Instructions for use Ambu® aScope™ 2 For single use only – Sterile For use by trained clinicians/physicians only. For in-hospital use.

Ambu® aScope™ Monitor For use by trained clinicians/physicians only. For in-hospital use.

USA Ambu Inc. 6740 Baymeadow Drive Glen Burnie, MD 21060 Tel.: +1 410 768 6464 +1 800 262 8462 Fax: +1 410 760 4907 www.ambuusa.com

France Ambu Sarl Les Bureaux du Parc Rue J. G. Domergue 33070 Bordeaux Cedex - France Tél. : +33 (0)5 57 92 31 50 Fax : +33 (0)5 57 92 31 59 www.ambu.fr www.ambu-shop.fr

Germany Ambu GmbH In der Hub 5 D-61231 Bad Nauheim Tel.: +49 6032 92500 Fax: +49 800 ambude www.ambu.de

Ambu® aScope™ 2

Pat. Pending

Ambu® aScope™ Monitor

UK Ambu Ltd. 8 Burrel Road St. Ives Cambridgeshire PE27 3LE Tel.: +44 (0) 1480 498 403 Fax: +44 (0) 1480 498 405 www.ambu.co.uk

Italy Ambu S.R.L Via Paracelso, 20 Centro Direzionale Colleoni 20864 Agrate Brianza - MB Italia Tel.: +39 039 657811 Fax: +39 039 6898177 www.ambu.it

Spain Firma Ambu S.L. Alcalá, 261-265, Edf. 2-3º dcha. 28027 Madrid Tel: +34 91 411 68 30 Fax: +34 91 564 50 82 www.ambu.es

Netherlands Schiphol Boulevard 127 1118 BG Schiphol Airport Tel.: +31 0182 52 60 60 Fax: +31 0182 52 70 73 www.ambu.nl

Australia Ambu Australia Pty. Ltd. Unit 2, 1 Prosperity Parade Warriewood NSW 2102 Australia Tel.: +6 1300 233 118 Fax: +6 1300 156 526 www.ambu.com

China Ambu Complex Building, No. C, 5th floor Xiang Yu F.T.Z. Xiamen 361006 China Tel.: +86 592 602 5212 Fax: +86 592 602 5390

Ambu A/S Baltorpbakken 13 DK-2750 Ballerup Denmark T +45 72 25 20 00 F +45 72 25 20 50 www.ambu.com

492 8101 00 - V05 - 2014/01

Corporate Head Office & Manufacturer: Ambu A/S Baltorpbakken 13 DK-2750 Ballerup Denmark Tlf. +45 72 25 20 00 Fax. +45 72 25 20 50 E-mail: [email protected] www.ambu.com

Contents

Page

1. Warnings, Cautions and Notes ... 5 2. Intended Use... 6 3. System Parts... 7 4. Contraindications... 7 5. Explanation of symbols ... 8 6. Technical product specifications... 10 7. Ambu aScope System ... 12 8. Clinical Application... 16 9. Preparation for Use ... 16 10. Use of the Ambu aScope system... 17 11. Trouble-shooting guide... 19 12. Warranty and replacement program ... 20 Appendix 1. Electromagnetic Compatibility... 20 Appendix 2. Standards applied... 22

Ambu is a registered trademark of Ambu A/S, Denmark. Ambu is certified according to ISO 13485.

1. Warnings, Cautions and Notes

Please read the manual and follow the instructions carefully. Throughout these instructions, appropriate warnings, cautions and notes are given describing potential safety hazards associated with use of the Ambu aScope system. KEY WARNINGS A warning is a statement that alerts the user to the possibility of injury, death, or other serious adverse reactions associated with the use or misuse of the device. • Do not use the Ambu aScope 2 if the product sterilisation barrier or its packaging is damaged. • Do not use the Ambu aScope system if it is damaged in any way. • Perform a functional check before using the Ambu aScope system (see section 9). Failure to pass any of the tests indicate that the Ambu aScope system should not be used. • Do not attempt to clean and reuse the Ambu aScope 2 on another patient as it is a Single use device. • The Luer channel is only to be used for topical anaesthesia or airflow using the supplied flow connector. Do not insert instruments, brushes etc. through the Luer channel as this may cause injury to the patient or damage the Ambu aScope 2. Do not use the Luer channel for, suction. • Use of airflow through the Luer channel shall not exceed 2.2 L/min and may only be used when paying special attention to the risk of increased pressure generated potentially causing e.g. barotrauma to the lungs. • The airflow through the device is not for the purpose of oxygenation or ventilation. • In case of massive bleeding in the airway do not use Ambu aScope 2. • The system is not to be used when delivering highly flammable anaesthetic gasses to the patient such as a Cyclopropane. This could potentially cause patient injury. • The Ambu aScope system is neither MRI safe nor MRI compatible. • Do not use the Ambu aScope system during defibrillation.

WARNINGS A warning is a statement that alerts the user to the possibility of injury, death, or other serious adverse reactions associated with the use or misuse of the device. • Pay attention to the battery symbol indicator on the Ambu aScope Monitor. Recharge the Ambu aScope Monitor when the battery level is low (see section 7.2.5). • Only to be used by skilled personnel trained in intubation and percutaneous tracheostomy procedures. • The Ambu aScope system is to be used only with patients who have been clinically evaluated by a physician as suitable for endotracheal intubation or percutaneous tracheostomy. • The size of the tubes used during the percutaneous tracheostomy procedure must be chosen to ensure sufficient oxygenation and ventilation of the patient. • Within percutaneous tracheostomy procedure be carefull not to damage the Ambu aScope 2 insertion cord during tracheal puncture. • Excessive force should never be used. • lf resistance is encountered when inserting the Ambu aScope 2, do not attempt to use force. • If a malfunction should occur during intubation, stop the procedure immediately, put the distal tip in its neutral and non-angled position and slowly retract the Ambu aScope 2. • To avoid potential patient injury the bending section and the distal tip must be placed in a neutral and non-angled position before the Ambu aScope 2 is removed from the patient. • The temperature of the distal end of the endoscope may reach up to 45C (113F) due to heating of the LEDs. Long, sustained contact with the mucosal membrane may cause mucosal injury. Avoid long periods of contact between the tip of the device and the mucosal membrane. •D o not touch the distal tip of the insertion cord or allow it to strike other objects. The lens surface of the distal tip is fragile and visual distortion may occur. • The Ambu aScope system consists of the parts described in section 3. No other parts must be used. • After the system has been used, refer to the Ambu aScope 2 post-check instructions before placing in a waste container. • If any test fails, take corrective action in order to reduce trauma to the patient. • The Ambu aScope 2 contains static-sensitive components. Handling precautions required. • Do not try to operate the bending section lever while the bending section is inside the endotracheal tube. Adjustment is not possible inside the tube and control wires may break if the lever is operated forcibly. • aScope 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. • Do not use cables or accessories other than those provided with the aScope system, as this may result in increased electromagnetic emissions or decreased immunity to such emissions. • If the aScope system is used adjacent to or stacked with other equipment, observe and verify normal operation of the aScope system prior to using it. Consult the tables in appendix 1 for guidance in placing the aScope system.

CAUTIONS A caution is a statement that alerts the user to the possibility of a problem with the device associated with its use or misuse. • US federal law restricts these devices for sale only by, or on the order of, a physician. • Have a suitable backup device readily available for immediate use. • Keep the Ambu aScope 2 handle and the Ambu aScope monitor dry. • Patients should be adequately monitored at all times during use. • Make sure that the Ambu aScope Monitor is fully charged before commencing the procedure. • When the Ambu aScope 2 is inserted through the mouth it is recommended to place a mouth piece to protect the Ambu aScope 2 from being damaged. • To minimize contamination, always wear gloves during preparation and intubation, and avoid contact with any unclean objects. • Do not manually twist or bend the bending section. Adjust only by operating the control lever, otherwise damage may occur. •W hen withdrawing the aScope 3, make sure that the control lever is in the neutral position. Otherwise there is a risk that the Ambu aScope 2 can be damaged and/or the patient may be injured. • Clean the Ambu aScope Monitor after each use. • Disconnect the Ambu aScope Monitor from any mains power supply before cleaning. • Place or hang the Ambu aScope Monitor on a stable support during installation. Dropping it could cause damage. • Position the power cord so that people cannot step on it. Do not place anything over the power cord. • Do not use a knife or other sharp instrument to open the pouch or cardboard box. • Only use the power supply that is supplied with the Ambu aScope Monitor, part number 4 in section 4. • If needed remove secretion or blood from the airway before and during the procedure. Appropriate suction device can be used for this purpose. • The Ambu aScope bending direction must be aligned with the curve of the tracheotomy tube. • Secure the tubing properly on the flow connector before the flow is introduced. • Remove camera protection foam part from the distal end before use. • Only use the video out cable supplied with the Ambu aScope Monitor. • Portable equipment may affect the normal function of the aScope system.

NOTES • The information given in these instructions serves only to instruct in the correct handling of the system. • Ambu is not responsible for any damage to the system or patient resulting from incorrect use. • Read these safety instructions carefully and keep them for later reference. • Disconnect the Ambu aScope 2 from the Ambu aScope Monitor and dispose of the Ambu aScope 2 in accordance with local guidelines for collection of infected medical devices with electronic components. • At the end of product life open the Ambu aScope Monitor, remove the batteries and dispose of them in accordance with local guidelines. • The batteries should only be removed from the Ambu aScope Monitor at disposal. • The batteries are not changeable. • To avoid risk of contamination, the Ambu aScope 2 cable should not lie on the floor. • During start up of the Ambu aScope Monitor flickering can appear on the screen for less than one second.

2. Intended Use

The Ambu aScope 2 is intended for use as an aid in the placement of an Endotracheal Tube (ETT) directly or through an intubating laryngeal mask during non- difficult and difficult intubating procedures or for visualization of the airway during Percutaneous Tracheostomy (PT) procedures. The Ambu aScope 2 achieves its purpose by providing the user with a visual confirmation of where the tip of the Ambu aScope 2 is in the human anatomy. The flexible tip of the Ambu aScope 2 allows the user to guide the ETT in the desired direction. The system is for use in a hospital environment. The target population is adults/children that have been clinically evaluated for ETT size 6 or larger.

3. System Parts

Before you install and use the system, please ensure that the following items are available:

Ambu aScope 2 - Single use device: 1. Ambu aScope 2

2. Flow connector

Instruction for use

Ambu® aScope™ 2

Single Patient Use Flexible Intubation Scope

3. Instruction for Use 492 8100 00 - V05 - Printed in Malaysia

Ambu aScope Monitor - Reusable device:

1. Ambu aScope Monitor

2. Monitor bracket (for attaching the monitor on e.g. an I.V. pole)

3. P ower supply and adaptors. Monitor power supply manufacturer: GlobTek, Inc. Monitor power supply part number: GS-1883(RE)

4. Cable for video out

4. Contraindications The system must not be used if, in the opinion of a qualified physician, such an application would endanger the patient or if the system as such or the method is contraindicated. The system is not to be used when delivering highly flammable anaesthetic gasses to the patient such as a Cyclopropane. This could potentially cause patient injury

In case of massive bleeding in the airway do not use Ambu aScope 2.

5. Explanation of symbols Symbol

Indication Connection for the Ambu aScope 2 Working length of the Ambu aScope 2 insertion cord Maximum width of insertion portion

Min ETT ID 6 mm

Minimum ET tube inner diameter 6.0mm (see section 10) Field of view Ambu aScope 2 is connected Battery status of the Ambu aScope Monitor Power supply is connected Do not use if the product sterilisation barrier or its packaging is damaged The product does not contain natural rubber latex On/Off button for Ambu aScope 2 and Ambu aScope Monitor

Increases values

Decreases values Brightness of image Contrast of image Connection to external monitor Electrical Safety Type BF Applied Part. Only relevant for Ambu aScope 2 Direct current Alternating current

IP50

Protection against dust Symbol of Class II equipment. Only relevant for Ambu aScope 2 Charger Only for indoor use. Only relevant for Ambu aScope 2 Charger

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

Symbol

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

Temperature limitation: temperature between 10° C/50° F and 40° C/104° F in operating environment CE mark. The product complies with the EU Council directive concerning Medical Devices 93/42/EEC. Company Address Reference Number Lot Number, Batch Code Serial Number Use By, followed by YYYY-MM Sterile Product, Sterilisation by ETO. Only applicable for the Ambu aScope 2. Single use product, do not reuse Warning Consult Instruction for use Year of Manufacture, followed by YYYY 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 Monitor 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 Monitor Li-ion

Battery type Lithium ion. Only applicable for the battery inside the Ambu aScope Monitor Re-chargeable battery. Only applicable for the battery inside the Ambu aScope Monitor Tested to comply with FCC Standards- Medical Equipment MEDICAL EQUIPMENT UL60601-1, IEC60601-2-18, CAN/CSA C22.2 No. 601.1, CAN/CSA C22.2 No. 601.2.18 Control no 4UD1. Only applicable for aScope Monitor INMETRO Certificate Medical Electrical Equipment ABNT NBR IEC 60601-1, ABNT NBR IEC 60601-1-2, ABNT NBR IEC 60601-2-18. Only applicable for aScope Monitor UL Recognized Component Mark for Canada and the United States. Only applicable for aScope 2. 9

6. Technical product specifications Ambu aScope 2 Optical System Field of View

80°

Direction of View

0° (forward viewing)

Depth of Field

9 mm - 18 mm (0.35 - 0.71 inch)

Illumination method

LED (LTW-C282DS5-SE)

Insertion cord Bending section

Up - down 120°, +/- 10° (please be aware that the bending angle can be affected if the insertion cord is not kept straight).

Maximum width of insertion portion

5.4 mm (0.21”)

Minimum tube size (inner diameter)

6.0 mm

Working length

630 mm (24.8”)

Scope Total length

830 mm (32.7”)

Luer channel (inner diameter)

0.8 mm (0.03”)

Luer channel entry

Luer connector

Flow connector Connecting tube inner diameter range

Ø 4 mm - Ø 10 mm

Max. flow rate

2,2 l/min

Operating environment Temperature Relative humidity Atmospheric pressure Altitude

10 ~ 40° C (50 ~ 104° F) 30 ~ 85% 80-109 kPa ≤ 2000 m

Storage Temperature

10 ~ 40° C (50 ~ 104° F)

Relative humidity

30 ~ 85%

Sterilisation Method of sterilisation

Table 1 - Specification for the Ambu aScope 2

Ambu aScope Monitor Dimensions Width

196 mm (7.76”)

Height

160 mm (6.30”)

Thickness

142 mm (5.60”)

Weight

1150 g (2.5lbs)

Display Max. resolution Orientation Display type Brightness control Contrast control Start up time

640 * 480 pixels Landscape 6.5” colour TFT LCD Yes, (“+” / ”-“) Yes, (“+” / ”-“) About 10 seconds

Electrical power Power requirement Battery type

12V 2.5A DC input 7.2V 2200mAh Li-ion battery

Operating environment Temperature Relative humidity Atmospheric pressure IP Protection Classification System Atmospheric pressure Altitude

10 ~ 40° C (50 ~ 104° F) 30 ~ 85% 80-109 kPa The Ambu aScope Monitor is classified IP50. 80-109 kPa ≤ 2000 m

Connection Video signal standard Video out connection Video out cable

NTSC 3.5 mm jack socket 3.5 mm jack plug to RCA jack plug

Storage Temperature Relative humidity

10 ~ 40° C (50 ~ 104°F) 10 ~ 90%

Mounting interface Mounting interface standard VESA MIS-D, 75 C, VESA FDMI compliant display, Part D, with centre located mounting interface Fixture Mounting interface Fits poles with thicknesses

75 mm (2.96”) 10 mm ~ 45 mm (0.4 ~ 1.8”)

Table 2 - Specification for the Ambu aScope Monitor

Ambu aScope Monitor power supply Dimensions Weight

245 g (0.54 lbs)

Electrical power Power requirement Power out

100 - 240V AC; 50-60Hz; 0.6A 12V DC; 2.08A

Operating environment Temperature

10 ~ 40° C (50 ~ 104° F)

Storage Temperature Relative humidity

10 ~ 40° C (50 ~ 104° F) 10 ~ 90%

Plugs Between the power supply and Ø 3.4 mm DC jack connector Ambu aScope Monitor 4 interchangeable types 1) Class II model NEMA 1-15P AC power plug with 2 prongs 2) Australian configuration: SAA 2 pins, class II 3) UK configuration: UK 2 pins, class II 4) European configuration: Europlug 2 pins, class II Table 3 - Specification for the Ambu aScope Monitor power supply

7. Ambu aScope System

The Ambu aScope system consists of the Ambu aScope 2 and Ambu aScope Monitor. To avoid a possible risk of cross-contamination the Ambu aScope 2 is a sterile single use device. The Ambu aScope Monitor is reusable.

7.1 Ambu aScope 2 The optical section of the Ambu aScope 2 consists of a camera in a flexible and sealed distal tip. Like all optical systems these parts are very delicate. Therefore careful handling of the Ambu aScope 2 is recommended. Flow connector The flow connector must only be used together with the Ambu aScope 2 in which it is supplied. If not used it must be discarded since it can not be considered sterile after the aScope pouch has been opened.

11 12

5 7 10 3 1

Figure 1 - The Ambu aScope 2

Number

Part

Function

Material

Distal tip

Camera

Epoxy

Bending section

Manoeuvrable part

PU (Polyurethane)

Insertion cord

Flexible airway insertion cord

PU (Polyurethane)

Connector on

Connects to Ambu

PE (Poly Ethylene) +

Ambu aScope 2 cable

aScope Monitor

PVC (Polyvinyl Chloride)

5 Ambu aScope 2 cable

Transmits the picture signal to the AmbuaScope Monitor

PVC (Polyvinyl Chloride)

Fixes the ET-tube during procedures

SEBS (Styrene Ethylene Butadiene)

ET-tube connection

7 Handle Suitable for both right and left handed use

MABS (Methyl Acrylonitrile Butadiene Styrene) + SEBS (Styrene Ethylene Butadiene)

8 Luer channel entry

The Luer entry fits a Luer entry connector and can be moved from side to side

SB (Styrene Butadiene)

- Luer channel

Can be used only for topical anaesthesia or for airflow using the supplied connector

PU (Polyurethane)

9 Flow connector

Allows for connection to an airsource via the Luer connector

ABS (Acrylonitrile Butadiene Styrene)

10 Camera protection foam

Protects the optical section of the Ambu aScope 2. Must be removed before use

EVA (Ethylene-vinyl Acetate)

Turns the Ambu aScope 2 on and off

PET (Poly Ethylene Phthalate)

On/off button

12 Bending control lever Moves the distal tip up or down

MABS (Methyl Acrylonitrile Butadiene Styrene)

- Protection pipe

Protects the insertion cord during transport and storage

PP (Polypropylene)

Sterile barrier

Cardboard, tyvek

Packaging

Table 4 – Functions and materials

7.2 Ambu aScope Monitor The monitor displays the video image from the Ambu aScope 2. If the Ambu aScope Monitor battery icon on the screen changes from fully charged to battery low within 30 minutes, it is recommended that the Ambu aScope Monitor is replaced. The Ambu aScope Monitor can be used for at least 150 intubations if it is stored, used and cleaned as described in this instruction for use.

2 12 7 8 6 5

9 10

Figure 2 - The Ambu aScope Monitor

Number Part Function Material 1 Monitor frame 2 Monitor screen Shows the picture from the camera 3 Bracket Secures the monitor to e.g. an IV pole 4 Power supply Powers the system 5 On/off button Push button for power ON before intubation and power OFF after intubation 6 Connection for Power supply and data connection for the Ambu aScope 2 7 Brightness This button controls and adjusts the brightness 8 Contrast This button controls and adjusts the contrast 9 Power Power inlet for charging the monitor 10 Video out The monitor provides a buffered video output of the video input from the Ambu aScope 2. This output is electrically isolated from the medical device by the monitor. The signal is a composite video NTSC signal 11 Video out cable The image can be viewed and/or recorded via a video output on an external monitor and/or video recorder 12 Pouch hook The Ambu aScope 2 pouch has a hole in the top corner. This hole allows the pouch to be hung on a hook for easier storage of the Ambu aScope 2 before or during use. The pouch can also be hung beside the Ambu aScope Monitor if placed on the bracket. The hook supplied with the Ambu aScope Monitor slides through the three holes on the bracket until it snaps into place. The pouch can now be hung on the hook 13 Hexagonal key To tighten the bolt on the bracket - Packaging For transportation purposes

PC (Polycarbonate) / ABS (Acrylonitrile Butadiene) Glass POM -GF25 (Polyoxymethylene with 25% glass filler) + aluminium PC (Polycarbonate) PC (Polycarbonate) PC (Polycarbonate) /ABS (Acrylonitrile Butadiene) Silicone Silicone -

PVC (Polyvinyl Chloride)

PA-GF40 (Polyamid with 40% glass filler)

CrV (Chrome Vanadium) Cardboard

Table 5 - Functions and materials

7.2.1 Assembling of the power supply Before charging the monitor the power supply must be assembled with the correct national adaptor: 1. Remove the protecting insert from the power supply before inserting the national adaptors

2. Insert the blade of the national adaptor:

Step 1a

Step 1b

Step 2

Step 3

Step 4

Step 5

Insert the tip of the adaptor into the power supply at a 30-60 degree angle (step 2). The top edge of the adaptor is flat and the bottom edge is U shaped. The power supply has the corresponding shapes. 3. Push the adaptor into the power supply in a downward motion (step 3) 4. Push the adaptor down until it locks in place. A clicking sound will occur (step 4). 5. Check for correct positioning by holding the power supply in one hand while using the other hand to pull up the adaptor (step 5).

7.2.2 Removal of adaptor 1.Use your thumb or finger to slide the locking pin downward. It is marked with an arrow. 2. Hold the locking pin down while pulling up and removing the adaptor.

7.2.3 Connecting the system The connection between the Ambu aScope 2 and the Ambu aScope Monitor is illustrated below. aScope

Monitor Power Supply

1. C onnect the monitor power supply to the wall socket and insert the power plug into the power inlet of the Ambu aScope Monitor. The system can be used without external power supply when the battery is fully charged. 2. Gently pull out the green rubber cap from the socket and insert the aScope 2 plug into the socket. After use remember to reinsert the green rubber cap to protect the socket.

aScope

Monitor

3. P ush the ON/OFF button on the Ambu aScope Monitor to start up the system. After about 10 seconds the Ambu aScope Monitor is ready to display the view.

4. Push the ON/OFF button on the Ambu aScope 2

7.2.4 Charging the monitor Connect the monitor power supply to the wall socket and insert the power plug into the power inlet of the Ambu aScope Monitor.

aScope

Monitor Power Supply

If the monitor is on during charging the battery icons will change as shown here: The monitor is not fully charged until the green plug icon changes to green battery icon Red plug

Orange plug

Green plug

Green battery icon fully charged

7.2.5 Advisory screen symbols on the Ambu aScope Monitor Battery symbol indicator on the Ambu aScope Monitor Ambu aScope Monitor battery icons Fully charged or above half battery capacity (green)

Start-up picture

Half battery capacity (orange) Low battery capacity (red)

Please wait...

Battery error (the power plug is connected but the battery is not charging)

Plug icons Ambu aScope 2 icon aScope 2 is connected

Plug is connected and the monitor battery is above half charged (green). Note: Monitor battery is not fully charged until green plug icon changes to green battery icon Plug is connected and the monitor battery is half charged (orange) Plug is connected and the monitor battery power is low (red)

Recharge the Ambu aScope Monitor when the green battery symbol changes to orange

7.2.6 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 takes approximately 2-3 hours. The battery should be charged at temperatures between 10 - 40°C.

7.2.7 Monitor placement on the bracket The Ambu aScope Monitor can be placed on a flat surface. But to secure the Ambu aScope Monitor it is recommended to use the bracket supplied. The bracket is mounted on a pole by tightening the wing nut and the Ambu aScope Monitor can then be placed on the bracket. To adjust the position of the Ambu aScope Monitor horizontally, loosen the wing nut and the bracket can be repositioned. To adjust the position of the Ambu aScope Monitor vertically, the monitor 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 Ambu aScope Monitor. The maximum allowed weight on the bracket must not exceed the weight of the one Ambu aScope Monitor and one Ambu aScope 2

7.2.8 Connecting to an external monitor/video recorder The design of the Ambu aScope Monitor enables it to be connected to an external monitor or video recorder if required for viewing and/or recording the session. The Ambu aScope Monitor is connected to an external monitor as shown in figure 4.

Only use the video out cable supplied with the Ambu aScope Monitor. Before the image can be seen on the external monitor/video recorder the Ambu aScope 2 must be turned on. To be able to view the image remember to select the appropriate source input on the external monitor. Note that only monitors and video recorders that accept a composite video NTSC signal can be used with the Ambu aScope Monitor. Also note that the quality of the image on the external monitor/video recorder can vary due to variations in the external equipment.

External monitor/ video recorder

Figure 4 - Connecting the Ambu aScope Monitor & the Ambu aScope 2 to an external monitor/video recorder

Be carefull when connecting the video out plug into the monitor. Make sure to use the correct socket marked with the symbol for video out. Note that the battery icon will only appear on the aScope Monitor and not on the external monitor.

8. Clinical Application

The flexible Ambu aScope 2 is designed so that it can adjust to anatomic variations. This is crucial in the management of difficult airways. In case of massive bleeding in the airway do not use Ambu aScope 2. If needed remove secretion or blood from the airway before and during the procedure. Appropriate suction device can be used for this purpose. Only to be used by skilled personnel trained in intubation and percutaneous tracheostomy procedures. Please be aware that these instructions do not explain or discuss clinical airway management procedures. They describe only the basic operation and precautions related to the operation of this Ambu aScope system. Before initial use of the Ambu aScope system, it is essential that the operator is familiar with the warnings, cautions, notes, indications and contraindications found in these user instructions. The Ambu aScope system must be handled in accordance with the recognised medical rules and procedures for endotracheal intubation and percutaneous tracheostomy procedures using an endoscope.

9. Preparation for Use Perform a brief functional check as described in this chapter before using the system. Failure to pass any of the tests indicate that the device should not be used. A physician who is familiar with this device can perform the preparation for use in a time range of 1-4 minutes. The tests should be conducted in a manner consistent with accepted medical practice to avoid contamination of the Ambu aScope 2 prior to insertion. Remember to remove the protective cover and protective foam from the scope before inserting it into the patient. Do not use the Ambu aScope system if it is damaged in any way. Before use, the outer surface of the Ambu aScope 2 insertion cord should be checked to ensure there are no rough surfaces, sharp edges or protrusions which may cause a safety hazard. 16

Visual inspection – Ambu aScope 2 1. Check that the pouch seal is not broken resulting in a non-sterile product 2. Check that there are no impurities on the product 3. Check that there are no missing items 4. Check that there is no evidence of shipping damage 5. Check that there are no cuts, holes, sharp edges, sagging, swelling or other irregularities on the bending section, lens, insertion cord 6. Check for any damage to the Ambu aScope 2 cable Do not use the Ambu aScope 2 if the product sterilisation barrier or its packaging is damaged. Visual inspection – Ambu aScope Monitor 1. Check for any damage to the Ambu aScope 2 cable and power supply (free from wear and tear) 2. Closely examine the monitor for any damage Functional test – Ambu aScope 2 1. Ensure that the tube slides over the insertion cord without resistance 2. Carefully slide the bending control lever forward and backwards in each direction until it stops. Confirm that the bending section functions smoothly and correctly. 3. Slide the bending lever slowly to its neutral position. Confirm that the bending section returns smoothly to an approximately straight position. 4. Connect the Ambu aScope 2 to the Ambu aScope Monitor to check picture signal Inspection of the image – Ambu aScope Monitor 1. Turn on the Ambu aScope. 2. Adjust the brightness and contrast level as appropriate. 3. If the object cannot be seen clearly, wipe the lens using a clean cloth. 4. Ensure the power supply is present and working. 5. When the Ambu aScope system is used without external power supply check the battery indicator on the monitor. Charge the monitor if the time remaining is not sufficient for the planned procedure. 6. It is recommended to locate nearest wall socket before start of procedure. 7.

It is recommended to have a power supply readily available before start of procedure.

Testing of the Luer channel – Ambu aScope 2 1. Ensure the channel is open by injecting 2ml of air through the channel using a syringe. 2. Using a syringe insert 2ml of sterile water into the channel. Depress the plunger, and ensure there are no leaks at the Luer entry, and that water is emitted from the distal end.

10. Use of the Ambu aScope system

Operating the Ambu aScope 2 The handle of the Ambu aScope 2 is designed to be held by either the left or right hand. The recommended hand position is shown. When the control lever is moved out of its neutral position, the physician will feel slightly more resistance as the control lever reaches its outermost limits. It is recommended to test the device prior to use, to get familiar with the resistance. When the control lever is moved to a position and released, the distal tip will return to a neutral position. When the control lever is pressed downwards the distal tip moves up. When moving the control lever upwards, the distal tip moves down.

Do not try to operate the bending section lever while the bending section is inside the endotracheal tube. Adjustment is not possible inside the tube and control wires may break if the lever is operated forcibly. The temperature of the distal end of the endoscope may exceed 45C (113F) due to heating of the LEDs. Long, sustained contact with the mucosal membrane may cause mucosal injury. Avoid long periods of contact between the tip of the device and the mucosal membrane. Attaching the endotracheal tube to the Ambu aScope 2 The endotracheal tube may be placed on the Ambu aScope 2 either with or without the ISO connection on the green ‘parking’ area. Important: When the endotracheal tube is railroaded onto the insertion cord, the internal diameter of the endotracheal tube has to be 6.0mm or more. Check that the endotracheal tube with the ISO connection slides without any resistance. 17

Do not touch the distal tip of the insertion cord or allow it to strike other objects. The lens surface of the distal tip is fragile and visual distortion may occur. Attaching the Flow connector to the Ambu aScope 2 Take out the flow connector from the small pouch and connect it to the Luer connector on the handle of the Ambu aScope 2 by twisting it clockwise into locked position. To detach it from the Luer connector twist the flow connector anti-clockwise. Insertion of or viewing with the Ambu aScope 2 The Ambu aScope 2 can be inserted through a tube placed to maintain an upper airway or through mouth or nose directly. When the Ambu aScope 2 is inserted, slightly advance it with the distal tip in a neutral position. View the image continuously on the Ambu aScope Monitor when passing the distal end of the Ambu aScope 2 through the upper airway anatomical structures. It is important to recognize these structures and avoid damage to the mucosal wall. Excessive force should never be used. lf resistance is encountered when inserting the Ambu aScope 2, do not attempt to use force. When the Ambu aScope 2 is inserted through the mouth it is recommended to place a mouth piece to protect the Ambu aScope 2 from being damaged. If the camera image of the Ambu aScope 2 becomes unclear the tip can be cleaned on the mucosal wall or with a piece of sterile gauze or a hospital disinfection wipe. Continue this procedure until a satisfactory image is obtained.

10.1 Injection and flow through the Luer channel The Ambu aScope 2 has a Luer channel where it is possible to inject topical anaesthesia or apply an airflow. The Luer is compatible with all syringes with ISO connection. It is recommended that the Luer channel is closed when it is not in use. Insert a syringe of topical anaesthetic into the Luer channel and press the plunger. To ensure that all the topical anaesthetic has left the channel, flush the channel with 2 ml of air. To apply a flow through the channel attach the flow connector to the Luer connector and attach a tube. Flow connector is compatible with tubes with an inner diameter of 4 to 10 mm. An intermittent airflow of 1-2 seconds tested at 2,2 l/min at a 5 bar backpressure can be used for directing secretion away from the tip of the Ambu aScope 2. The flow rate must not exceed 2,2 l/min. Use of flow through the Luer channel shall not exceed 2.2 L/min and may only be used when paying special attention to the risk of increased pressure generated potentially causing e.g. barotrauma to the lungs. The Luer channel is only to be used for topical anaesthesia or airflow using the supplied flow connector. Do not insert instruments, brushes etc. through the Luer channel as this may cause injury to the patient or damage the Ambu aScope 2. Do not use the Luer channel for suction.

10.2 Removal procedure Slowly withdraw the Ambu aScope 2 while observing the image on the Ambu aScope Monitor. The distal tip must be in a neutral and non-deflected position. Otherwise there is a risk that the Ambu aScope 2 can be damaged and/ or the patient may be injured. Disconnect the Ambu aScope 2 from the Ambu aScope Monitor and dispose of the Ambu aScope 2 in accordance with local guidelines for collection of infected medical devices with electronic components. If the Ambu aScope 2 is used more than once on the same patient during the same procedure, place it on a sterile surface in between sessions.

10.3 Post-check guide After the system has been used, refer to the Ambu aScope 2 post-check instructions before placing in a waste container. If any test fails, take corrective action in order to reduce trauma to the patient. Visual test – Ambu aScope 2 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 radiopaque 18

10.4 Cleaning of the Ambu aScope Monitor: The Ambu aScope Monitor must be cleaned and disinfected according to the instructions before first use. 1. Prepare a cleaning solution using a standard enzymatic detergent (Enzol or equivalent) prepared per manufactures recommendations. Recommended detergent: enzymatic, mild pH: 7-9, low foaming. Contact Ambu A/S for further information on recommended detergents. 2. Soak a sterile gauze in the enzymatic solution and then wring out to ensure that the gauze is not dripping. 3. Thoroughly clean the buttons, screen and external casing of the monitor with the damp 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 buttons until all evidence of soil is removed. 5. Wait for 10 minutes to (or the time recommended by the manufacturer of the detergent) allow the enzymes to activate. 6. Rinse the device using sterile gauze that has been dampened with RO/DI water. Ensure all evidence of the detergent is removed. 7. Repeat steps 1 to 6.

10.5 Disinfection of the Ambu aScope Monitor The Ambu aScope Monitor must be cleaned and disinfected according to the instructions before first use. Immediately after use, remove any soiling from the exterior of the Ambu aScope Monitor. 1. Wipe the surfaces of the Ambu aScope Monitor during approximately 15 minutes using a piece of sterile gauze dampened with the alcohol mixture indicated below (approximately once every 2 minutes). Follow safety procedures for handling isopropyl. The gauze should not be dripping since liquid can affect the electronics inside the Ambu aScope Monitor. Pay close attention to buttons, screen, external casing, slots and gaps on the Ambu aScope Monitor. Use a sterile cotton swab to reach these areas. Solution

Concentration

Isopropyl (alcohol) 95%

70-80% 80cc of 95% Isopropyl (alcohol) added to 20cc of purified water (PURW)*

Preparation

*Alternatively, use EPA-registered hospital desinfection wipes containing at least 70% isopropyl. Safety precautions and use directions of the manufacturer shall be followed. 2. After cleaning and disinfection, the Ambu aScope Monitor must be submitted to the pre-check procedure in section 9. 3. The Ambu aScope Monitor must be stored between procedures in accordance with local guidelines

10.6 Disposal The Ambu aScope 2 is a Single use device. The Ambu aScope 2 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. Do not attempt to clean and reuse the Ambu aScope 2 on another patient as it is a Single use device. The Ambu aScope Monitor is a reusable device. At the end of its product life, the Ambu aScope Monitor and power supply must be disposed of in accordance with local regulations and collection schemes for disposal of electronic and electrical devices. The battery inside the Ambu aScope Monitor is to be removed only at the end of the product lifetime. The battery must be disposed of in accordance with local regulations and collection schemes for disposal of batteries. In order to remove the battery, use a Torx screwdriver to remove the battery lid.

11. Trouble-shooting guide

If problems occur with the system, please use this trouble-shooting guide to identify the cause and correct the error. No Picture Cause Action Ambu aScope 2 not connected to Ambu aScope Monitor Connect an Ambu aScope 2 Ambu aScope Monitor not turned on Turn on the monitor. Allow about 10 seconds start-up time. Brightness and contrast settings are wrong Adjust contrast and brightness using the designated buttons on the monitor Ambu aScope 2 not turned on Turn on the Ambu aScope 2 No power on Ambu aScope Monitor Charge Ambu aScope Monitor or connect the Ambu aScope Monitor to the power supply. This can be done during the procedure Low picture quality Cause Action Light reflecting on the monitor screen Move the monitor to a position where no direct light influences the screen Dirty/damp screen Wipe the screen with a clean cloth Brightness and contrast settings not optimal Adjust the contrast and brightness using the designated buttons on the monitor Blood, saliva etc. on the lens (distal tip) Wipe the lens with a clean cloth 19

12. Warranty and replacement program

The warranty period for the Ambu aScope Monitor is one year from delivery to the customer. We agree to replace an Ambu aScope Monitor free of charge if proof can be provided of faulty materials or faulty workmanship. In doing so we cannot accept the cost of transportation or risk of shipment. There is no warranty on the Ambu aScope 2. A defective Ambu aScope Monitor must be handled exclusively by persons authorised by Ambu A/S. During our inspection of the Ambu aScope Monitor you will receive an identical replacement of the Ambu aScope Monitor. To prevent infection, it is strictly forbidden to ship contaminated medical devices. The medical device (Ambu aScope Monitor or Ambu aScope 2) must be decontaminated on site before shipment to Ambu. The cleaning and disinfection procedures explained in 10.4 and 10.5 shall be followed. Ambu reserve the right to return contaminated medical devices to the sender.

Appendix 1. Electromagnetic Compatibility Like other electrical medical equipment the aScope system requires special precautions to ensure electromagnetic compatibility with other electrical medical devices. To ensure electromagnetic compatibility (EMC) the aScope system must be installed and operated according to the EMC information provided in this manual. The aScope system has been designed and tested to comply with IEC 60601-1-2 requirements for EMC with other devices. Portable equipment may affect the normal function of the aScope system o not use cables or accessories other than those provided with the aScope system, as this may result in increased electromagnetic emission D or decreased immunity against such emission. If the aScope system is used adjacent to or stacked with other equipment, observe and verify normal operation of the aScope system prior to using it. Consult the tables below for guidance in placing the aScope system. Guidance and Manufacturer’s Declaration: Electromagnetic Emissions aScope system is intended for use in the electromagnetic environment specified below. The customer or the user of aScope system should ensure that it is used in such environment Emissions Test RF emissions CISPR 11 EN 55011 Harmonic emissions IEC/EN 61000-3-2 Voltage Fluctuations/Flicker emissions IEC/EN 61000-3-3

Compliance

Result

Group 1, Class B

Pass

N/A

Complies

Pass

Electromagnetic Environment - Guidance

aScope system is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Guidance and Manufacturer’s Declaration: Electromagnetic Immunity aScope system is intended for use in the electromagnetic environment specified below. The customer or the user of aScope system shall ensure that it is used in such an environment Immunity Test

IEC 60601 Test Level

Compliance Level

Electromagnetic Environment Guidance

Electrostatic Discharge (ESD) IEC/EN 61000-4-2

+/-6kV contact +/-8kV air

2; 4; 6kV contact 2; 4; 8kV air

If floors are covered with synthetic material the relative humidity shall be at least 30%

Electrical Fast Transient/Burst AC Power port: +/-2kV – EFT Signal cable greater than 3 metres IEC/EN 61000-4-4 +/- 1kV

Surge Immunity Test IEC/EN 61000-4-5

+/- 1kV differential mode +/- 2kV common mode

+/- 2kV Power line No signal cable greater than 3 metres. Open circuit Voltage: 1.2/50µs Short circuit current: 8/20µs AC power Port line to line: 1kV Line to earth (ground) 2kV

Mains power quality should be that of a typical commercial or hospital environment

Voltage Dips, short interruptions and voltage variations on power supply input lines IEC/EN 61000-4-11

<5% Ut (95% dip in Ut) for 0.5 cycle

100% reduction 0.5 period

40% Ut (60% dip in Ut) for 5 cycles

40% reduction for 5 periods

70% Ut (30% dip in Ut) for 25 cycles

30% reduction for 25 periods

<5% Ut (95% dip in Ut) for 5 sec.

100% reduction for 5 sec.

Power frequency (50/60Hz) magnetic field IEC/EN 61000-4-8

3 A/m

Conducted Radio Frequency Disturbance Test – CS. IEC/EN 61000-4-6

3Vrms 150kHz to 80MHz

0.15 – 80MHz, 3Vrms, 80% AM, 2Hz

3V/m; 80Hz to 2.5GHz

80-2500 MHz, 3V/m, 80% AM(2Hz)

Radio Frequency Electromagnetic Field Susceptibility Test – RS IEC/EN 61000-4-3

Mains power quality should be that of a typical commercial or hospital environment If the use of aScope system requires continued operation during power mains interruptions the aScope system can be powered by the built in rechargeable battery. Mains power quality should be that of a typical commercial or hospital environment

Portable and mobile RF communications equipment should be used no closer to any part of the aScope system, including its cables, than the recommended separation distance calculated from the equipment of the frequency of the transmitter. Recommended Seperation Distance D = 1.17√P

Note 1: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a)

Field strengths from fixed transmitters, such as base stations for radio (celluar/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast, and TV broadcast, cannot be predicted theoretically with accuracy. To assess the electromagnetic environment from fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the aScope system is used exceeds the applicable RF compliance level above, the aScope system should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the aScope system unit. Over the frequency range 150kHz to 80MHz, field strengths should be less than 3V/m

Recommended Separation Distances Between Portable and Mobile RF Communication Equipment and aScope system. The aScope system is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The user of the aScope system can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters and the aScope system as recommended below, according to the maximum output power of the communication equipment. Separation distance (m) according to frequency of transmitter Rated maximum output power (W) of transmitter 0.01 0.1 1 10 100

150kHZ to 80MHz D = 1.17√P

80MHz to 800MHZ D = 1.17√P

800MHz to 2.5GHz D = 2.33√P

0.12m 0.37m 1.17m 3.70m 11.70m

0.23m 0.74m 2.33m 7.37m 23.30m

For transmitters rated at a maximum output power not listed above, the recommended separation distance (D) in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. Note 1: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

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