Related Manuals for Ambu aScope Gastro
Summary of Contents for Ambu aScope Gastro
- Page 1 INSTRUCTIONS FOR USE Abridged version Ambu Gastroscope ® For use by trained healthcare professionals. For use in professional healthcare facilities. For use with Ambu aBox ® ™ aScope Gastro ™ aScope Gastro Large ™...
- Page 2 QUICK GUIDE Ambu aBox™ 2 pMax CO pMax H O : 500 kPa / 72.5 psi 80 kPa / 12 psi pMax VAC: -76 kPa / -11 psi...
- Page 3 CONTENTS PAGE English (Instructions for use) ��������������������������������������������������������������������������������������������������������������������������������4-19...
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Page 4: Intended Use
1. Important information – Read before use Read the Instructions for Use (IFU) carefully before using the Ambu® aScope™ Gastro or Ambu® aScope™ Gastro Large� These instructions describe the function, setup and precautions related to operating the Ambu® aScope™ Gastro or Ambu® aScope™ Gastro Large� Please be aware that these instructions do not describe clinical procedures�... - Page 5 4� Patient leakage currents may be additive, when using energised endotherapy accessories� Do not use energised endotherapy accessories which are not classified as "type CF" or "type BF" applied parts according to IEC 60601-1, as that could lead to too high patient leakage current�...
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Page 6: Device Description
2. Device description The endoscope is to be connected to an Ambu displaying unit� For information about Ambu displaying units, please refer to the Ambu displaying unit’s Instructions for Use� 2.1. Device Parts... - Page 7 Figure 1: Schematic representation of the endoscope with references to relevant components. Part Function Control section The user holds the endoscope at the control section with the left hand� The control wheels and remote switches/programmable buttons may be manipulated with the left and/or right hand�...
- Page 8 No. on Fig.1 Part Function Remote switches/ The user activates functions on the displaying unit� programmable The functions of the remote switches/programmable buttons buttons are pre-configured from factory and can be re-configured according to the user’s preference� Each button can be programmed to be sensitive on both short and long press�...
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Page 9: Device Compatibility
“self-sealing”, “shut-off-filter” or similar� • Gastrointestinal endotherapy accessories specified to be compatible with a working channel with an inner diameter (ID) of 2�8 mm/8�4 Fr or less for aScope Gastro and with an ID of 4�2 mm/12�6 Fr or less for aScope Gastro Large� •... -
Page 10: Use Of The Device
Should any irregularity be observed after inspection, follow the instructions as described in section 6 "Troubleshooting"� If the endoscope malfunctions, do not use it� Contact your Ambu sales representative for further assistance�... -
Page 11: Inspection Of The Endoscopic System
(ID) of 2�8 mm/8�4 Fr or less for aScope Gastro and with an inner diameter (ID) of 4�2 mm/12�6 Fr or less for aScope Gastro Large are compatible� There is no guarantee that endotherapy accessories selected using only this minimum working channel size will be compatible with the endoscope�... -
Page 12: Operating The Device
Checking the remote switches/programmable buttons • All remote switches/programmable buttons should be checked to work normally even if they are not expected to be used� • Press every remote switch/programmable button and confirm that the specified function works as expected� •... -
Page 13: After Use
Accessories should be compatible if they are designed for working channels with an inner diameter (ID) of 2�8 mm/8�4 Fr or less for aScope Gastro and with an ID of 4�2 mm/12�6 Fr or less for aScope Gastro Large, and/or for a distal tip with an outer diameter (OD) of 9�9 mm for aScope Gastro and an OD of 11�5 mm for aScope Gastro Large�... -
Page 14: Device Specifications
– ISO 8600-1 Endoscopes – Medical endoscopes and endotherapy devices – Part 1: General requirements� 4.2. Technical device specifications Product specification Insertion section dimensions aScope Gastro aScope Gastro Large 1�1 Bending angle 210° 210° Down: 90°... -
Page 15: Troubleshooting
The following tables show the possible causes of and countermeasures against challenges that may occur due to equipment setting errors or damage to the endoscope� Make sure to contact your local Ambu representative for detailed information if indicated� Prior to use please do the pre-check as described in section 3�... - Page 16 Possible problem Possible cause Recommended action Insufflation not possible The water bottle is empty� Replace the water bottle with or insufficient� a new one� CO₂ regulator is not working Refer to the CO₂ regulator IFU� or not switched on� Sterile water source setup Confirm that water source is suboptimal�...
- Page 17 Endoscope is defective� Withdraw the endoscope and connect a new endoscope� Displaying unit is defective� Contact your Ambu representative� Image suddenly Camera or illumination failure� Switch ON LEDs as described in darkens� displaying unit IFU� Withdraw the endoscope and connect a new endoscope�...
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Page 18: Explanation Of Symbols Used
Picture is frozen� Endoscope is defective� Withdraw the endoscope and connect a new endoscope� Unusual image Displaying unit is defective� Contact your Ambu contrast levels� representative� Advanced Red Contrast (ARC) See displaying unit IFU� mode unintentionally ON/OFF� Improper image/ARC settings�... - Page 19 Indicates that a Consult instruction product is compliant for use with European legislation for medical devices and that it has Do not re-use been verified by a notified body A full list of symbol explanations can be found on ambu�com/symbol-explanation�...
- Page 20 Ambu Ltd Ambu A/S First Floor, Incubator 2 Baltorpbakken 13 Alconbury Weald Enterprise Campus 2750 Ballerup Alconbury Weald Denmark Huntingdon PE28 4XA T +45 72 25 20 00 United Kingdom ambu�com ambu�co�uk Ambu® and other trademarks are trademarks of Ambu A/S�...
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