Amiea Med EXCEED - Default Chapter; Table of Contents

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Exceed

TABLE OF CONTENTS

1 GENERAL INFORMATION ................................................................................................ 3

1.1 Instruction for Use .....................................................................................................3

1.2 Warning symbols and statements used in this Instruction for Use ..................3

1.3 Limitation of liability ...................................................................................................4

1.4 Technological advances ............................................................................................4

2 PURPOSE – INDICATIONS FOR USE ............................................................................ 4

2.1 Required qualiﬁcations (user requirements) .........................................................4

2.2 Intended use – requirements for safe use ............................................................5

3 DEVICE DESCRIPTION ..................................................................................................... 6

4 CONTRAINDICATIONS ...................................................................................................... 9

4.1 Risks and beneﬁts .....................................................................................................9

5 WARNINGS AND PRECAUTIONS ................................................................................10

5.1 Operating precautions ............................................................................................10

5.2 Operating conditions .............................................................................................12

5.3 Clinical precautions ................................................................................................12

5.4 To reduce the risk of sharps injury or electrical shock .....................................13

6 UPON RECEIPT OF YOUR EXCEED MICRONEEDLING SYSTEM .......................14

6.1 Initial setup ............................................................................................................... 14

6.2 Switching the device to OPERATING or STANDBY MODE ........................ 17

6.3 Conﬁgure control unit (menu) ..............................................................................18

6.4 Switching handpiece ON and OFF ..................................................................... 19

6.5 Controlling the device with the footswitch ........................................................20

6.6 Changing the puncture frequency ....................................................................... 20

7 SAFETY NEEDLE CARTRIDGE AND BARRIER SLEEVE ........................................21

7.1 Safe use of the safety needle cartridge ............................................................. 21

7.2 Fitting the handpiece cover ..................................................................................21

7.3 Attaching the safety needle cartridge to the handpiece ................................. 22

7.4 Removing the safety needle cartridge and the barrier sleeve from the

handpiece .................................................................................................................23

7.5 Setting the needle protrusion depth ................................................................... 25

8 TREATMENT INSTRUCTIONS .......................................................................................27