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7.1

  To avoid the theoretical risk of pressure trauma to the posterior pharyngeal 

wall, the combined weight of the video laryngoscope should be supported 

through the Handle. Take care not to allow the weight of the Video Viewer 

to displace the other components.

7.2

  The video laryngoscope is unsuitable for use in intense magnetic fields, 

e.g. magnetic resonance imaging (MRI). Do not keep or use close to sensitive 

electronic equipment.

7.3

  Do not reuse single use devices, this may cause cross-infection, reduce 

product reliability and functionality.

AAM Healthcare warrants the hardware products to be free from defects in material 

and workmanship under normal use and service. AAM Healthcare’s obligation 

under this warranty is limited to correcting the defect in the product or any part 

thereof which is defective in material or workmanship during the warranty period.

Replacement shall be determined by AAM Healthcare wherein such supplies fail to 

meet applicable specifications and were purchased directly from AAM Healthcare 

or an AAM Healthcare authorised party, for use with APA

 products, and provided 

the Buyer or Customer has complied with the handling, storage and shelf life 

requirements as specified by AAM Healthcare. Any attempts to modify or open 

up the device will void its warranty automatically. AAM Healthcare shall have no 

responsibility whatsoever for consumable supplies purchased from any other source.

THE ABOVE WARRANTIES ARE EXCLUSIVE OF, AND IN LIEU OF, ALL OTHER 

WARRANTIES, WRITTEN OR ORAL, EXPRESS OR IMPLIED, STATUTORY OR 

OTHERWISE. NO IMPLIED STATUTORY WARRANTIES OF MERCHANTABILITY OR 

FITNESS FOR A PARTICULAR PURPOSE SHALL APPLY. AAM HEALTHCARE SHALL 

NOT BE LIABLE FOR ANY DAMAGES SUSTAINED BY BUYER ARISING FROM DELAY 

IN THE REPLACEMENT OR REPAIR OF PRODUCTS UNDER THE ABOVE WARRANTY.

Terms and conditions may change without prior notice. Different charges may apply 

for APA

 product after the 1 year warranty period unless otherwise specified.

The following symbols appear on the device and packaging materials. 

Consult Instructions for Use (IFU):

 www.AAMHealthcare.com/IFU

Do not re-use (APA

 blades and IP Shield)

Non-sterile

Caution: Federal (USA) law restricts this device to sale by or on the 

order of a physician. (APA Oxy Blade

 and Stylet)

Not made with natural rubber latex

Does not contain phthalates

Type B: Provides a basic degree of protection against electric shock 

as specified in the standard IEC60601-1. The applied part typically 

has direct earth connection.

Direct current

Protection of equipment against ingress of solid foreign objects 

 2.5 mm diameter. Protection against access to hazardous parts 

with a tool, thick wire, etc. Protection against water falling as a spray 

at any angle up to 60° from the vertical shall have no harmful effect.

Protection of equipment against ingress of dust is not entirely 

prevented, but it must not enter in sufficient quantity to interfere 

with the satisfactory operation of the equipment; complete protection 

against contact. Protection against vertically falling water drops 

when equipment is tilted up to 15°.

7. 

WARNINGS AND PRECAUTIONS

9. 

Symbols used on labelling

8. Warranty

Summary of Contents for APA Video Laryngoscope

Page 1: ...it ISTRUZIONI PER L USO ja 使用説明書 ko 사용설명서 nl GEBRUIKSAANWIJZING no BRUKSANVISNING pl INSTRUKCJA UŻYCIA pt INSTRUÇÕES DE UTILIZAÇÃO sv BRUKSANVISNING tr KULLANMA TALİMATI zh 使用说明 Venner Medical Singapore Pte Ltd 35 Joo Koon Circle Singapore 629110 www vennermedical com Advena Ltd Tower Business Centre 2nd Flr Tower Street Swatar BKR 4013 Malta www advenamedical com ...

Page 2: ...lade 15 2 6 5 APA Stylet 16 2 7 Removing the blade after use 16 3 Battery and charging information 17 3 1 Charging instructions for the Video Viewer 17 3 2 Video Viewer LED light indicators 18 3 3 Battery replacement in the Handle 19 4 Decontamination 20 4 1 Preparation 20 4 2 Cleaning 20 4 3 Disinfection 21 4 4 Sterilisation 21 4 4 1 Low temperature 21 4 4 2 Steam sterilisation 21 4 5 APA IP Shie...

Page 3: ...ryngoscopy in routine and difficult airway intubations It may be used to facilitate endotracheal intubation as part of general anaesthesia or CPR cardiopulmonary resuscitation during cardiac arrest It is suitable for use in pre hospital hospital and extended care facilities The video laryngoscope is reusable DEHP free and latex free It is fully detachable into three components APA Video Viewer APA...

Page 4: ...ble To record video the video cable may be connected to a suitable recording device The Video Viewer cannot be autoclaved and must be cleaned and disinfected between first use and each patient use refer to Section 4 The Handle incorporates and is powered by a single replaceable alkaline or lithium AA 1 5V battery and the Camera Module incorporates a high intensity light source and a miniature came...

Page 5: ...n a non sterile reusable state It will be necessary to clean it before use refer to Section 4 Check the battery of the laryngoscope Before using the device as a standard laryngoscope ensure that the Camera Module illuminates when the device locks in the ON position CAUTION The AA 1 5V battery MUST be changed regularly Inadequate battery level may cause the laryngoscope to fail suddenly without war...

Page 6: ...place until the limit of travel is reached Figure 3 3 To confirm correct attachment rotate the Camera Module into the ON position the Video Viewer screen should then turn on If using as a video laryngoscope the Video Viewer should be attached to the laryngoscope before using on a patient CAUTION If an image cannot be seen on the Video Viewer check that it is correctly attached to the Handle Avoid ...

Page 7: ... the epiglottis is elevated by lifting the Handle of the laryngoscope exposing the laryngeal inlet With direct visualisation of the laryngeal inlet a correctly sized ETT EndoTracheal Tube can be introduced into the trachea Ensure that the ETT is adequately lubricated prior to use An introducer stylet may be used to assist the introduction Correct placement of the ETT should be both visual and by t...

Page 8: ...t With direct visualisation of the laryngeal inlet a correctly sized ETT EndoTracheal Tube can be introduced into the trachea Ensure that the ETT is adequately lubricated prior to use An introducer stylet may be used to assist the introduction Correct placement of the ETT should be both visual and by the use of capnography Figure 3 7 Introducing the device with MIL Blade Figure 3 8 Connecting the ...

Page 9: ... fitted with the charger indefinitely if desired To begin charging attach the appropriate plug adapter to the charger Figure 4b and connect to the mains power supply Once connected align the convex point of the Video Viewer connector with the concave point of the Video Viewer Charger connector to confirm correct charging direction Figure 4c Attachment is made easy by the magnetic pins in the conne...

Page 10: ...the battery level is sufficient If the LED light indicator starts to flash during a procedure it means that there is limited battery The procedure may continue at the clinician s discretion The Camera Module is supplied with an alkaline AA 1 5V battery When used as a standard laryngoscope the Camera Module illuminates when the device locks in the ON position The battery should be replaced regularl...

Page 11: ...sed bag for transportation to the sterile processing unit for sterilisation CAUTION Only the Handle and Camera Modules may be sent for reprocessing Prepare or dilute a suitable disinfectant in accordance with the manufacturer s instructions Visit the U S Environmental Protection Agency EPA website for a list of registered disinfectants Spray or wipe the components with a suitable disinfectant i e ...

Page 12: ...battery If the illumination still does not work contact the local distributor for servicing refer to Section 5 5 Service and maintenance 6 Troubleshooting 6 1 As a video laryngoscope 6 2 As a laryngoscope The video laryngoscope should be inspected at regular intervals for Visible signs of external damage Scratches or defects on the Camera Module lens Build up of material on connection pin area of ...

Page 13: ...IN LIEU OF ALL OTHER WARRANTIES WRITTEN OR ORAL EXPRESS OR IMPLIED STATUTORY OR OTHERWISE NO IMPLIED STATUTORY WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE SHALL APPLY AAM HEALTHCARE SHALL NOT BE LIABLE FOR ANY DAMAGES SUSTAINED BY BUYER ARISING FROM DELAY IN THE REPLACEMENT OR REPAIR OF PRODUCTS UNDER THE ABOVE WARRANTY Terms and conditions may change without prior notice Dif...

Page 14: ...g instructions for this product Residents outside the European Union must dispose or recycle this product in accordance with local laws or regulations that apply Device should be stored and used between 4ºC and 40ºC Keep dry Keep away from sunlight Date of manufacture Legal manufacturer EU and Manufactured for US Authorised representative in the European Community European Conformity mark Class 1 ...

Page 15: ...thcare All rights reserved AAM Healthcare APA and Venner are trademarks of the Venner Group of Companies This product is covered by patents and patent applications of the Venner Group of Companies in the US and other territories Visit www AAMHealthcare com intellectual property 2266 H January 2019 ...

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