Zimmer re User manual

Instructions for Use
reIModel
EN

Contents
Page
1
Introduction
1.1 Overview
1.2 Intended use
1.2.1 About the device
1.2.2 Device application specifications
1.3 Applications
1.3.1 Side effects
1.4 System description
1.4.1 Classifications
1.5 Specifications and requirements
1.5.1 Specifications of the high-frequency therapy device
1.5.2 Electrical specifications
1.5.3 Environmental requirements
1.5.4. Display, safety and reference symbols
1
3
4
4
5
2
Safety
(warnings!)
2.1 Electrical hazards (hazards due to radiofrequencies)
2.2 Hazards during assembly
2.3 Risk of fire
2.4 Hazards due to laser radiation
2.5 Hazards induced by cleaning
2.6 Compliance with regulations
2.7 Contraindications
2.8 Caution during start-up
2.9 Caution during operation
2.10 Caution after use
2
2.10 Caution after use
9
12
12
12
13
13
14
14
14
14
3
Description
3.1 Structure
3.2 Operating principle
3.3 Components
3.4 Device accessories
15
16
17
16

Contents
4
Use
4.1 Site preparation
4.1.1 About site preparation
4.1.2 Assembly of the main body and handpiece connection
4.1.3 Assembly of the handpiece and tip
4.1.4 Disassembly of the main body and handpiece connection
4.1.5 Disassembly of the handpiece and tip
4.1.6 Switching on/off
4.2 Operation
4.2.1 About operation
4.2.2 Instructions for use
4.2.3 System start-up
4.2.4 Screen
4.2.5 Main device
4.2.6 Handpiece
4.3 Error messages
4.3.1 Handpiece error
4.3.2 Tip error
4.3.3 Program error
19
22
29
5
Maintenance
5.1 Cleaning
5.2 Technical customer service
5.3 Cleaning procedure
5.4 Environmental requirements
30
31
31
31
6
Labelling and packaging
6.1 Labelling data
6.2 Packaging label
32
30
7
Disposal
34
8
Electromagnetic compatibility
35
9
Legal notice
37

Contents
These instructions for use are an integral part of the device. They must be stored with the device and kept accessible at
all times for anyone authorised to operate this device.
The instructions for use are valid as of September 2022.
If the instructions for use have become illegible, damaged, or are not accessible for other reasons to the person
appointed to operate the device, a replacement is to be requested from the manufacturer for the safe use of the reModel*
device and made available to the user. This also includes the information on the labels on the device.
The instructions for use can also be downloaded from our website at www.zimmer-aesthetics.de.
We reserve the right to revise this document at any time or change product specifications described. There is no
obligation to provide information about the changes to the customer.
*Registered product name Powershape2

Introduction
1.1 Overview
1
Page 1
Description, natural
course and after-
effects of diseases
High-frequency therapy is used in musculoskeletal disorders (MSD). These are
injuries to or pain in the human musculoskeletal system, including the joints,
ligaments, muscles, nerves, tendons, and structures that support the extremities,
neck, and back. MSD can develop due to sudden exertion (e.g. lifting a heavy object),
or by repeating the same movements, including repeated stress. They can also
develop due to vibrations, the repeated application of force, or improper posture.
Injuries to or pain in the musculoskeletal system caused by acute traumatic events,
such as a car accident or a fall, are not considered musculoskeletal diseases,
however. MSD can affect many different parts of the body, including the upper and
lower back, the neck, and the shoulders and extremities (arms, legs, feet and hands).
Examples of MSD are carpal tunnel syndrome, epicondylitis, tendinitis, back pain,
tension neck syndrome, and hand-arm vibration syndrome.
Clinical form, stages,
and degrees of severity
Workers remain in the same position over long workdays and often for several years;
even natural body postures such as standing can lead to MSD such as back pain.
Rather unnatural postures in particular, such as twisting or strain in the upper body,
contribute to the development of MSD through their unnatural biomechanical stress.
There are indications that poor posture contributes above all to MSD of the neck,
shoulder, and back. Repeated movement is another risk factor for occupational MSD:
when workers have to make the same movements repeatedly over a long period of
time, this can wear out joints and muscles involved (for example, typing can lead to
carpal tunnel syndrome). Even repeated movements at a fast pace of work with little
recovery time increase the risk of MSD, and workers with no or little control over the
timing of the movements (such as on assembly lines) are more prone to MSD. Regular
movements with a high degree of exertion also increase the risk of MSD since the
muscles tire faster which can lead to injuries and/or pain. In addition, the effects of
vibrations (such as in the case of truck drivers or construction work) and extremely hot
or cold temperatures can promote the development of MSD. The vibration exposure is
also associated with hand-arm vibration syndrome which presents symptoms due to a
lack of blood circulation of the fingers, such as nerve compression, tingling, or
numbness.
Incidence in the
general population
General information
Musculoskeletal diseases are a growing health problem worldwide and are the second
most common cause of disability. In the USA, for example, more than 16 million cases
of strains and sprains were treated in 2004 and the total costs for the treatment of
MSD are estimated to be more than 125 billion dollars per year. In 2006, approx.
14.3% of the Canadian population lived with a disability, nearly half of whom suffered
from MSD. Neck pain is among the most common complaints. Every year, about one
fifth of adults worldwide report pain in this area.
Workplace
Most MSD episodes at the workplace concern several parts of the body. MSD are the
most common complaints of workers in Europe, the USA, and in the Asia-Pacific
region, and the third most common reason for disability and early retirement in the
USA. In 2014, the incidence rate of MSD among the working population was 31.9
newly diagnosed MSD per 10,000 full-time staff. In the same year, the average
number of sick days due to MSD was 13; in addition, there were 10.4 MSD cases per
10,000 full-time staff in whom an MSD led to 31 or more days of absence. The MSDs
are just as widespread in professions with high biomechanical stress such as
construction and factory work as in occupations with little stress, such as office work.
The transport and storage industries, with an incidence rate of 89.9 cases per 10,000

Introduction
1.1 Overview
1
Page 2
full-time staff, have the highest incidence rate of musculoskeletal diseases. In the
health, processing, agriculture, wholesale, retail and leisure industries, the incidence
rates are over 35 per 10,000 full-time staff. For example, a national survey of US
nurses revealed that 38% suffered an MSD in the previous year, primarily injuries to
the lower back. In workers, the neck and back are affected most frequently, followed
by the upper and lower extremities. The Office of Labour Statistics reports that 31.8
new cases of MSD per 10,000 full-time staff can be attributed annually to overexertion
or repeated movements.

Introduction
1.2 Intended use,
device specifications
1
Page 3
1.2 Intended use
The high-frequency therapy device is intended for an effect which offers relief of
musculoskeletal pain.
1.2.1 About the device
The reModel system was developed in accordance with international safety and
performance standards. The staff operating the system must have acquired a basic
understanding of the proper operation of the device. This manual was created to help
medical and technical staff understand and operate the system. Please read it
carefully before using the device. If part of this manual is not clear, please contact your
local Eunsung Global representative for further clarification.
The reModel high-frequency therapy device is equipped with three different
technologies: for the therapy, you can select between the various handpieces for high
frequency, low-level laser, or vacuum. The handpiece with high frequency and laser,
consisting of three different sizes for different parts of the body, is primarily used to
relieve musculoskeletal pain.
In reModel, the functions in the high-frequency, low-level laser and vacuum modes
must be adjusted via the LCD display of the device.
This device consists of the main body, handpiece 1, handpiece 2, handpiece 3, and
power cable.
Specifications: Vacuum: MAX. 280 mm Hg ± 20%, HF: Max. 83 W ± 20%;
50 Ohm, laser: < 5 mW, safety: In the event of overload, the power supply is
automatically disconnected by each fuse attached to the power line. To prevent the
device from being accidentally switched on by third parties, this function is still
operated via a key switch. The key switch must be operated to be able to turn on the
device.
1.2.2 Device application specifications
Target patient group
1. Suitable for all adults with the exception of pregnant women.
2. Weight: not relevant.
3. State of health: All patients, with the exception of the patient groups listed
under “Side effects”.
4. Nationality: all.
5. The treatment should not be performed on patients who tend to develop
nervousness and agitation.
Preconditions for
operation
1. Training:
Physicians or clinical professionals.
2. Knowledge:
Can read and understand basic terms in English (screens).
Can read and understand German.
Sufficient knowledge in medicine specialising in the reduction of
subcutaneous fat.
3. Language comprehension:
English –Basic terms (screens)
German

Introduction
1.3 Applications
1.4 System description
1
Page 4
Use
•The device is intended for use by physicians or medical professionals.
•Use the device in a clean treatment room.
•Position the device on a flat, straight floor surface.
•Frequency of use: Can be used daily.
•Mobility: There are four wheels on the underside of the device for transport.
Applications
1.3 Applications
High-frequency therapy is a method of electrotherapy for the reliable relief of
musculoskeletal pain. It generates deep heat (diathermy) in the body using high-
frequency alternating current. The high-frequency therapy with the reModel device is
indicated in a variety of indications, for example, in painful diseases of the
musculoskeletal system or in chronic inflammation. (Source: pschyrembel.de, keyword
“high-frequency therapy”)
The many preset, indication-based treatment programs make the treatment easy and
safe.
Side effects
1.3.1 Possible side effects
Swelling, burns, erythema
System description
1.4 System description
1.4.1 Classifications
In accordance with the directive for medical devices, the high-frequency therapy
device corresponds to class IIa in accordance with appendix IX rule 9.
In accordance with EN60601-1 (2007) the following classifications are used:
Protection against electric shock Class I ME device.
Applied part of type BF
Sterilisation method: not applicable.

Introduction
1.5 Specifications and requirements
1
Page 5
Specifications of the
high-frequency therapy
device
Applicator
Roll handpiece
1 variant
Multipolar handpiece
1. large, 2. medium,
3. small
Thermal handpiece
1. large, 2. small
Vacuum
MAX. 280 mm Hg ± 20%
HR
Max. 83 W ± 20%; at 50 Ohm
Laser
< 5 mW
Input power
230 V~, 50 Hz (max. 500 VA)
Display
10.2" LCD touch screen
Dimensions
(WxDxH) mm
414 × 523 × 1230 mm
Weight
Approx. 60 kg
HF outlet
Watt
Handpiece
Load (Ω)
Level
10
50
200
500
1000
Roll
5
101.1
50.2
30.0
14.2
6.1
10
166.5
82.9
49.5
23.3
9.9
Multipolar
- large
5
16.4
21.3
18.9
9.9
5.5
10
25.3
35.4
31.4
16.3
8.9
Multipolar
- medium
5
13.2
15.6
13.0
6.7
3.2
10
23.7
29.3
24.6
12.8
5.9
Multipolar
- small
5
6.7
8.0
6.6
3.4
1.7
10
11.4
13.4
10.7
5.5
2.7
Thermal
- Section 1
5
8.7
9.2
6.7
3.3
1.7
10
17.4
16.7
12.1
6.1
3.0
Thermal
- Section 2
5
10.6
11.0
8.0
4.0
1.9
10
21.0
19.5
14.1
7.1
3.4
Thermal
- Section 3
5
8.9
9.4
6.9
3.4
1.7
10
17.7
16.7
12.0
6.1
3.0

Introduction
1.5 Specifications and requirements
1
Page 6
* HF outlet in the case of a nominal load, 50 Ω
Handpiece
Level
Veff
Watt
Handpiece
Level
Veff
Watt
Roll
1
38.4
29.5
Multipolar
- large
1
25.6
13.1
2
41.2
33.9
2
27.3
14.9
3
44.2
39.1
3
29.1
16.9
4
47.1
44.4
4
30.8
19.0
5
50.1
50.2
5
32.6
21.3
6
53
56.2
6
34.5
23.8
7
55.9
62.5
7
36.4
26.5
8
58.8
69.1
8
38.3
29.3
9
61.6
75.9
9
40.2
32.3
10
64.4
82.9
10
42.1
35.4
Handpiece
Level
Veff
Watt
Handpiece
Level
Veff
Watt
Multipolar
- medium
1
19.3
7.4
Multipolar
- small
1
15.3
4.7
2
21.7
9.4
2
16.5
5.4
3
24
11.5
3
17.6
6.2
4
25.9
13.4
4
18.9
7.1
5
27.9
15.6
5
20
8.0
6
30
18.0
6
21.3
9.1
7
32
20.5
7
22.3
9.9
8
33.9
23.0
8
23.7
11.2
9
36.1
26.1
9
24.7
12.2
10
38.3
29.3
10
25.9
13.4
Thermal
- Section 1
1
15.3
4.7
Thermal
- Section 2
1
16.4
5.4
2
16.7
5.6
2
18.1
6.6
3
18.4
6.8
3
19.8
7.8
4
19.9
7.9
4
21.6
9.3
5
21.4
9.2
5
23.4
11.0
6
23.1
10.7
6
24.8
12.3
7
24.6
12.1
7
26.5
14.0
8
26
13.5
8
28.1
15.8
9
27.6
15.2
9
29.7
17.6
10
28.9
16.7
10
31.2
19.5

Introduction
1.5 Specifications and requirements
1
Page 7
Handpiece
Level
Veff
Watt
Handpiece
Level
Veff
Watt
Thermal
- Section 3
1
15.6
4.9
2
17
5.8
3
18.4
6.8
4
20.1
8.1
5
21.7
9.4
6
23.1
10.7
7
24.6
12.1
8
26.2
13.7
9
27.5
15.1
10
28.9
16.7

Introduction
1.5 Specifications and requirements
1
Page 8
Electrical specifications
1.5.2 Electrical specifications
The customer must have a suitable plug and an appropriate socket. The power
outlet must be within two metres from the site intended for the high-frequency
therapy device and must be grounded. The safety ground wire of the power
system (green strip or green-yellow strip) is an acceptable grounding for the high-
frequency therapy device, provided that it is connected only to a ground spike or a
special grounding grid. Incorrect grounding can impair the operation of the high-
frequency therapy device.
WARNING
WARNING!
Do not touch the power cable with wet hands.
The input voltage line should be free of voltage peaks (voltage peaks, voltage
drops and overvoltages).
A dedicated branch circuit is recommended.
The operation of the device at a power line that does not meet the specification
can damage the system and invalidate the warranty.
Environmental
requirements
1.5.3 Environmental requirements
Before assembling the high-frequency therapy device, the intended site must be
prepared as described in this section. The correct electrical configuration and the
correct power outlets must be provided and the additional environmental
specifications indicated in the following paragraphs must be met.
Ensure that the atmosphere is not corrosive and that there are no salts or acids in
the air.
Acids, corrosive substances, and volatile materials can impair electrical
connections and the surfaces of optical components.
The high-frequency therapy device was tested and meets the limit values for
medical devices according to EN 60601-1-2:2015. These limit values should
ensure appropriate protection from damaging interference in a typical hospital
environment.

Introduction
1.5 Specifications and requirements
1
Page 9
Safety and reference
symbols
1.5.4. Display, safety and reference symbols
Manufacturer
Importer
Model name or reference number
Authorised representative established in the European Community
Serial number
Follow the disposal procedures in this manual
Date of manufacture
See user manual
Alternating current
Applied part type BF
“ON” (current)
“OFF” (current)
Protective earth (ground)
Warning
Do not push
Temperature limit
WARNING: Laser beam
Protect from moisture!
Fragile, handle with care
Package direction

Introduction
1.5 Specifications and requirements
1
Page 10
Humidity limitation

Safety (warnings!)
2.1 Electrical hazards (hazards due to
radiofrequencies)
2
Page 11
WARNING!
Please read this manual carefully before use to ensure that you are familiar
with the features and functions.
This manual contains important information on assembly, safety notices, and on
the use and care of your device. Please be sure to read all safety information and
operation instructions before use.
WARNING!
Do not use any inflammatory anaesthetics.
WARNING!
Changes to the components are not permitted.
WARNING!
To avoid the risk of electrical shock, this device may be connected only to a
mains supply with protective ground.
Electrical hazards
(hazards due to
radiofrequencies)
2.1 Electrical hazards (hazards due to radiofrequencies)
•Pull the plug out of the socket immediately after each use.
•Do not place or store the device such that it could fall over or get into a tub or
sink.
•Do not allow the device to be immersed in or fall into water or other liquids.
•Do not reach for a device which has fallen into water. Immediately pull the plug
out of the socket.
•Never operate this device
- with a damaged mains cable or plug,
- if it is not working properly,
- if it has been dropped or damaged, or
- if it has fallen into water.
•Even in the case of minor problems or damage, send the device to your
healthcare provider to be checked and repaired.
•Keep the power cable away from hot surfaces.
•Patients should not come into contact with grounded metal parts or parts with
noteworthy ground capacitance.
•First start with a low output power and increase this gradually in order to avoid
negative treatment effects.

Safety
2.2 Hazards during assembly, 2.3 Risk of fire, 2.4
Hazards due to laser radiation
2
Page 12
Hazards during
assembly
2.2 Hazards during assembly
•Do not expose this device to direct sunlight. Assemble the device in well
ventilated interior rooms.
•Place the device only on a flat, straight surface.
•Protect the device from impacts. Impacts can lead to damage of the device.
•No changes which were not authorised by the manufacturer in advance should
be made to the device.
Risk of fire
2.3 Risk of fire
•reModel should not be used in the vicinity of flammable substances in order to
avoid fire and the risk of explosion.
•Flammable materials such as fabric or coverings should not be used or should
be kept at a safe distance from the device.
Hazards due to laser
radiation
2.4 Hazards due to laser radiation
•Visible laser radiation: Avoid contact of direct or scatter radiation with the eyes
or skin.
•Never look directly into the handpiece, the fibres, or the fibre opening, even
when you are wearing protective goggles.
•Mark the treatment rooms with laser warning signs to prevent unnecessary
personnel from being in the room during the treatment.
•Cover reflective surfaces such as jewellery or mirrors which could direct the
laser beam into an area other than the intended treatment area.
Laser warning signs
On the back of the device
On the back of the device
On the roll handpiece, and
On the multipolar handpieces (large, medium-sized)
WARNING
Changes and the use of procedures other than those described here can lead to
hazardous radiation exposure.

Safety
2.5 Cleaning-induced hazards
2.6 Compliance with regulations
2
Page 13
Hazards induced by
cleaning
2.5 Hazards induced by cleaning
•Neither the main body nor the handpiece may be immersed in liquid.
Please switch off the AC power switch before cleaning the device.
•Use a soft cloth for cleaning and disinfection. Always keep the device and
handpiece clean in order to achieve optimum performance.
•It is recommended to use non-flammable agents for cleaning and
disinfecting, where applicable.
•After cleaning/disinfecting the device, ensure that no solvent residues
remain on the device before you start the therapy.
•Ensure that patients do not come into contact with solvents.
•Before treatment with the device, ensure that no flammable liquids are on
the skin or in body depressions or cavities.
Compliance with
regulations
2.6 Compliance with regulations
•Use only original accessories. Otherwise there can be device failures and
damage to the device and the entitlement to service expires.
•Never attempt to repair the device yourself. This device should be repaired
or maintained only by qualified maintenance staff. Please contact the
service centre for maintenance, repair, or adjustment.
•If the device is soiled, clean it with a soft cloth.

Safety
2.7 Contraindications, 2.8 Caution during start-up,
2.9 Caution during operation, 2.10 Caution after use
2
Page 14
Contraindications
2.7 Contraindications
Please do not use the device
•on children, infants, and pregnant women
•in the case of diseases such as cardiovascular diseases, liver diseases,
kidney diseases, cancer, diabetes
•if there is an infection of the treatment area
•on patients with keloids
•on patients with pacemakers
•if anti-inflammatory drugs are taken regularly, and
•on patients with sensitive problem skin,
•for patients with pacemakers or other active implants, there is a possible
hazard due to a disruption in the function of the pacemaker which could
become damaged. In case of doubt, qualified advice should be sought.
Caution during start-up
2.8 Caution during start-up
•Check the power cable.
•Do not use the device in places with water or fire.
•Ensure that the device location is free of damaging influences through
temperature, humidity, agents/solvents containing salt, and ionic
components.
Caution during
operation
2.9 Caution during operation
•The device may not be used by unauthorised persons.
•Do not use the device if there are any malfunctions.
•Avoid jerky movements when using this device.
•Please be aware that the output of the vacuum pump can be changed
during operation with an external mains voltage source.
Caution after
use
2.10 Caution after use
•Please note that you may start cleaning and maintenance only after the
device has been switched off.
•Protect the device from direct contact with water.
•If the device is soiled, clean it with a soft cloth.

Description
3.1 Structure
3
Page 15
Structure
Service life of the
device
The service life of the reModel device is 10 years (depending on the vacuum pump).
Reuse
The reModel device must be cleaned and prepared after each treatment. Please
contact the manufacturer or your distributor if there is a problem.
Software version:
V1.36
Handpiece holder
Air filter
Drawer
LCD monitor
Handpieces

Description
3.2 Operating principle
3
Page 16
Operating principle
3.2 Operating principle
The reModel high-frequency therapy device is equipped with three different
technologies: with a high-frequency function, with a low-level laser, and with the
function for vacuum massage. The handpiece for high-frequency and laser treatment
comprises three different sizes for different parts of the body and is primarily used to
relieve musculoskeletal pain.
The energy emission is controlled by pressing the button on the handpiece.
When the vacuum is switched on, air is aspirated through the solenoid valves
through underpressure in the handpiece.
oHigh-frequency section: the HF circuit board generates a pulse with 2 MHz
and transmits this to the amplifier. The pulse is emitted via the high-voltage
transformer.
oLaser function: This function is operated with charging capacity. The sealed
laser tubes generate the laser beam with a wavelength of 660 nm by
charging the high voltage into the sealed laser tubes, then the laser beam is
applied to the painful area.
oVacuum function: The air is aspirated to the lower section of the handpiece.
The air aspirated into the vacuum motor flows through the air filter and the
solenoid valve.