Human Med Body-Jet Evo User manual

User Manual
„In this world, there is nothing softer and thinner than water.
But to compel the hard and unyielding it has no equal.“
(Laozi)

Human Med AG
User manual body-jet
®
evo
Doc-No.: 900054
Rev./Date: 0/29.08.2012
ISO 13485
User manual for body-jet
®
evo
Item no.
: 500000
-
7
All rights to these operating instructions are reserved, in particular the rights of reproduction, distribution and translation.
No part of these operating instructions may be reproduced in any form whatsoever (photocopy, microfilm or any other process), or
processed, reproduced or distributed using electronic systems without the prior written permission of Human Med.
The information included in these operating instructions may be amended or supplemented without prior notification and does not
represent any obligation on the part of Human Med.
Printed by Human Med AG
Printed in Germany
Copyright © Human Med AG; Wilhelm-Hennemann-Straße 9, 19061 Schwerin, Germany; 2012

Doc-No.: 900054
Rev./Date: 0/29.08.2012
Human Med AG
User manual body-jet
®
evo

Table of contents
Human Med AG
User manual body-jet
®
evo
Doc-No.: 900054
Rev./Date: 1/03.12.2012
Page 1
Table of contents
1. General description of the body-jet
®
evo 1-2
1.1. Medical indications 1-2
1.2. Contraindications 1-2
2. Safety precautions and safety features 2-2
2.1. Significance of the safety symbols 2-2
2.2. Adherence to the safety instructions 2-2
2.3. Safety of equipment and instruments 2-2
2.4. Safe practice by medical staff 2-3
2.5. Significance of the user manual and training if medical staff 2-3
2.6. Electrical safety and electromagnetic compatibility 2-4
2.7. Prevention of electrical shock 2-4
2.8. Particular safety instructions for use of the body-jet
®
evo 2-5
3. Description of the body-jet
®
evo 3-2
3.1. Functions and operating elements of the body-jet
®
evo 3-2
3.1.1. Functional elements 3-2
3.1.2. Control panel for device operation 3-4
3.1.3. Functional elements of the suction unit 3-7
3.1.4. Device label, meaning of device label symbols and other symbols 3-9
3.2. Description of the WAL applicator and WAL cannulae 3-11
3.2.1. Elements of the sterile singe-use WAL applicator 3-11

Table of contents
Page 2 Doc-No.: 900054
Rev./Date: 1/03.12.2012
Human Med AG
User manual body-jet
®
evo
3.2.2. Instructions for the use of the WAL cannulae 3-12
4. Preparatory activities 4-2
4.1. Installation of the body-jet
®
evo 4-2
4.1.1. Ambient conditions 4-2
4.1.2. Installation of the body-jet
®
evo 4-3
4.1.3. Components / device combination 4-4
4.1.4. Preparations for use 4-5
4.1.4.1. Visual check 4-5
4.1.4.2. How to bring the rack into working position 4-5
4.1.4.3. How to bring the rack into transport position 4-7
4.1.4.4. Attachment of the fluid bags 4-8
4.1.4.5. Connection of the body-jet
®
evo 4-8
4.2. Device settings 4-10
4.3. OP preparations 4-11
4.3.1. Switch-on of the body-jet
®
evo 4-11
4.3.2. Selection of the OP mode 4-11
4.3.3. OP preparation in OP mode „WAL“ 4-12
4.3.3.1. Preparation of the suction unit 4-12
4.3.3.2. Connection of the WAL applicator 4-16
4.3.3.3. Fixation of the tubing 4-21
4.3.3.4. Connection of the suction tube 4-22
4.3.3.5. Venting of the infiltration pump 4-23

Table of contents
Human Med AG
User manual body-jet
®
evo
Doc-No.: 900054
Rev./Date: 1/03.12.2012
Page 3
5. Working with the body-jet
®
evo 5-2
5.1. Working with the body-jet
®
evo in the OP mode „WAL“ 5-2
5.1.1. Description of the OP screen in the OP mode „WAL“ 5-2
5.1.1.1. Infiltration 5-2
5.1.1.2. Aspiration 5-4
5.1.1.3. LipoCollection 5-5
5.1.1.4. Fluid 5-6
5.1.2. Attachment of a WAL cannula and weater jet test 5-8
5.1.3. Operation 5-11
5.1.4. End of operation 5-14
5.1.4.1. Display of the fluid consumption 5-15
5.1.4.2. Removal of the infiltration pump 5-16
5.1.4.3. Post-processing of the device 5-20
5.2. Working with the body-jet
®
evo in the OP mode „SUCTION ONLY“ 5-21
6. Troubleshooting 6-2
6.1. Faults of suctioning and infiltration flow 6-2
6.2. Applicator coding 6-5
6.3. Error messages 6-6
6.4. Detection of an infiltration pump in the socket 6-9
7. Cleaning, disinfection, transport and storage after OP 7-2
7.1. Cleaning and disinfection after OP 7-2

Table of contents
Page 4 Doc-No.: 900054
Rev./Date: 1/03.12.2012
Human Med AG
User manual body-jet
®
evo
7.1.1. Before cleaning and disinfection 7-2
7.1.2. Cleaning and disinfection 7-2
7.1.3. After cleaning and disinfection 7-4
7.2. Storage and transport 7-5
7.2.1. Storage and transport inside the medical clinic / practice 7-5
7.2.2. Storage and transport outside the medical clinic / practice 7-6
8. Technical data 8-2
9. Maintenance, warranty, disposal and customer service 9-2
9.1. Maintenance 9-2
9.1.1. Authorized persons 9-2
9.1.2. Safety inspections 9-2
9.1.3. Modifications and replacement of components 9-3
9.1.4. Periodic maintenance 9-3
9.2. Warranty 9-3
9.3. Disposal 9-4
9.4. Customer service 9-4

Chapter 1 - General description of the body-jet
®
evo
Human Med AG
User manual body-jet
®
evo
Doc-No.: 900054
Rev./Date: 0/29.08.2012
Page 1-1
Contents
1. General description of the body-jet
®
evo ...................................................................................................................................... 2
1.1. Medical indications ........................................................................................................................................................................ 2
1.2. Contraindications........................................................................................................................................................................... 2

Chapter 1 - General description of the body-jet
®
evo
Page 1-2 Doc-No.: 900054
Rev./Date: 0/29.08.2012
Human Med AG
User manual body-jet
®
evo
1.
General descrip
tion of the body
-
jet
®
evo
The body-jet® evo was specifically designed for the aesthetic plastic surgery, and in particular, for water-jet-assisted liposuction
(WAL). The body-jet
®
evo is a newly designed version from the body-jet
®
series and incorporates many technical innovations with
improved ease of operation.
The body-jet
®
evo generates a pulsed water jet, for which there are three different water pulse options (PULSATIONS). In
addition, there are four RANGE options. The infiltration flow and pressure can be adjusted by combination of both.
The body-jet
®
evo is operated via a touch screen, in which all settings and current values are clearly legible. The intuitive menu
navigation with integrated help function ensures easy operation of the device.
The body-jet
®
evo is equipped with an error menu navigation giving support in troubleshooting in case of operating or system
errors.
As protection for the patient, the body-jet
®
evo also features a system function precluding the reuse of WAL applicators and the
use of WAL applicator copies.
1.1. Medical indications
In addition to applications in liposuction for body shaping and treatment of lipoedema the body-jet
®
evo from Human Med can also
be used for recovery of natural body fat for autologous adipose tissue transfer.
1.2. Contraindications
The body-jet
®
evo and the instruments to be connected are not approved for intra-cardiac application.
The body-jet
®
evo must not be used in patients with severe coagulation disorders.