Zimmer enPulsPro Instructions For Use Manual

Instructions for Use

enPulsPro

EN

Illustrations

Front of the device

Fig. 1

Selection and

operating elements

1 Control unit

2 Pulse energy controller

3 Display

4 Frequency controller

5 Slot for SD card

6 Power switch

Handpiece

7 Handpiece

8 Vent, front

9 Vent with fan, rear

10 Holder for hand piece

Footswitch

11 Footswitch

Optional

accessories

12 Rotatable swivel foot

2

5

7

8

4

3

10

11

1

9

12

6

Illustrations

Rear of the device

Fig. 2

Switches/sockets

13 Socket for mains cable

14 Mains fuse

15 Socket for handpiece channel I

16 Socket for handpiece channel II

17 Socket for footswitch

18 Identification plate

16

15

17

13

18

14

Illustrations

Screens / Displays

Fig. 3

Display/

treatment screen

19 On-screen buttons

20 Status bar

21 Navigation bar

22 VAS- Pre scale

23 VAS- Post scale

Fig. 4

Navigation bar

Description of the

functions

(A) Back

Takes you back one step

(B) Therapy

Switches to the therapy screen

(C) History

(D) Protocols

Switches to the VAS evaluation

Switches to protocols

(E) Programs

Switches to the program list

(F) Favorites

Switches to the favorites area

20

21

19

F

E

D

C

B

A

22

23

Illustrations

Applicator heads and accessories

Fig. 5

Applicator heads

24 Applicator head, 25 mm

25 Applicator head, 15 mm

26 Applicator head, 6 mm

Accessories

27 Silicone protection cap

24

25

26

27

Explanation of Symbols

In the instructions for use, this symbol indicates danger.

Caution

!

In the instructions for use, this symbol indicates a "Caution" with regard to

possible damage of the device.

Socket for handpiece

Socket for footswitch

Instructions for use

Follow instructions for use

Serial number

Article number

Manufacturer

Date of manufacture

Applied part type BF

Value of accessible fuses

Interval operation - Follow instructions for use

Contents

Illustrations

Front of the device

Rear of the device

Screens / Displays

Applicator heads and accessories

Explanation of Symbols

Page

1

Indications / Contraindications 1

2

Side Effects 2

3

Application Information 3

4

Warnings 4

5

enPulsPro – in brief 5

6

Device Set-Up 6

7

Settings 7

8

Operating Instructions

8.1 Device Description

8.2 Notes on Operation

8.3 Performing the Treatment

8.4 Display and Buttons

8.5 SD Card

8.6 Protocols

8.7 Favourites List – Retrieving Programs and Editing Lists

8.8 VAS – Visual Analogue Scale

9

11

12

13

15

16

18

21

9

Technical Information

9.1 Info-Chart Duration of Treatment 25

27

10

Cleaning / Disinfection 28

Contents

11

CE mark 31

12

Scope of Delivery and Accessories 32

13

Device Combinations 33

14

Safety and Maintenance

14.1 Safety

14.2 Maintenance

34

35

15

Functional test 36

16

Safety Check / Metrological Control 37

17

Error Messages / Troubleshooting/ Disposal 38

18

Manufacturer’s EMC Declaration 41

Valid for the device enPulsPro (NG).

These instructions for use is an integral part of the device. They must be stored

with the device and be accessible at all times to anyone authorised to operate

the device.

The instructions for use is valid as of February 2016.

Indications / Contraindications

1

Page 1

Indications

• Radial and ulnar epicondylitis

• Calcifying tendonitis/shoulder problems

• Condition post blunt muscle injuries

• Chronic patellar tendon syndrome

• Patellar tendinitis

• Chronic tendinopathy of the Achilles tendon

• Plantar fasciitis

• Heel spurs

• Myofascial trigger point treatment, e.g. in the neck

• Myofascial trigger point treatment, e.g. the back in the case of muscular back

pain

• Trochanteric bursitis

• Periostitis/Tartan syndrome (condition post overloading)

Contraindications

• vascular diseases in or in the vicinity of the treatment area

• open wounds in or in the vicinity of the treatment area

• local infections in the treatment area

• Application in the area of malignant/benign tumours

• Application directly to cartilage surfaces or in the area of the

• small facet joints of the spine

• Application directly via implanted electronic devices, e.g. pacemakers or pain

pumps

• In areas where mechanical energy in the form of vibrations leads to damage

of the tissue, e.g. metal supply

• After fracture, in the case of torn muscle fibres or muscle tears

In general, treatments are not recommended

• For bleeding disorders or treatments that result in a change in blood

coagulation

• During pregnancy

• In diseases involving a disorder of the vasomotor system in the treatment

area

• Via air-filled spaces (e.g. treatment of the thoracic spine)

• Generalized pain syndromes, e.g. fibromyalgia

• In children, especially in the area of the epiphyseal plates

Care is required for patients

• with impaired sensibility

• with severe autonomic disorders

• under the influence of drugs and/or alcohol

as circulatory stresses and inadequate treatment responses cannot be

excluded.

Side Effects

2

Page 2

Side Effects

Treatments with the enPulsPro may occasionally cause irritation, petechiae,

haematoma, swelling, or pain.

Application Information

3

Page 3

Before using the device on patients, users should familiarise themselves with

the operating instructions and individual treatment methods to be used as well

as the indications/contraindications and warnings/instructions for use.

Additional sources of information about the treatment should also be observed.

Caution

!

Before use, ensure that the device is operated via a properly grounded socket

(electrical installation in accordance with DIN VDE 0100 Part 710). The device

may only be operated with the supplied power cable. The power cable must be

protected against mechanical stress.

Caution

!

The operation of devices with strong electromagnetic fields (e.g. tomography,

X-ray, or diathermy equipment) may interfere with the operation of the device.

Please maintain a safe distance of several metres.

The enPulsPro is not suitable for use in explosive, flammable, or combustive

environments.

During use, the device must be located in a position that allows direct access to

the mains power supply so that this can be disconnected at any time.

To prevent the risk of electric shock, the plug must be disconnected from the

power supply before performing any maintenance or cleaning activities.

Inspect the device before use. If there is any damage, do not use the device.

Caution

!

Only use accessories from Zimmer MedizinSysteme GmbH.

Caution

!

The handpiece of the device is not designed for continuous operation. After a

max. 6,000 strokes, a treatment pause of 15 min is required.

Caution

!

If the enPulsPro is not mounted on a designated wagon, ensure that the

enPulsPro is placed on a stable surface.

Caution

!

To avoid heat accumulation in the handpiece, ensure that the vents on the top

and especially the bottom of the handpiece are not blocked (i.e. by the hand or

otherwise).

Warnings

4

Page 4

In the extreme case, the maximum treatment time is limited to 4 min followed

by a break of at least 15 min.

If the treatment time is exceeded, the handpiece may overheat.

Users of the enPulsPro shockwave treatment device must be instructed in the

proper use of the system and have the appropriate knowledge.

Treatment instructions pertaining to the location, duration and intensity of

treatment require medical knowledge and may only be given by licensed

physicians, therapists and members of the medical auxiliary professions .

These instructions must be followed without fail.

The patient must not be left unattended during treatment.

Persons undergoing simultaneous treatment with reduction and/or alteration of

blood clotting or a prolongation of clotting time (e.g. acetylsalicylic acid) should

consult a health care professional about a possible discontinuation of this

treatment as the use of radial shock waves can readily lead to increased

bleeding and bruising.

Shock waves are strongly scattered in air-filled areas and produce reflections

that can have negative effects.

Direct treatments should therefore not be performed above the lungs

(intercostal space) and gastrointestinal area.

Use in wet areas is not permitted; this may result in considerable damage and

endanger both the patient and the user.

Under certain circumstances, the treatment time is limited to 4 min and a 5

minute break. If this cycle is exceeded, the handpiece can overheat.

enPulsPro – in brief

5

Page 5

What is enPulsPro?

An ultra-modern, innovative shockwave treatment device.

Shockwave treatment

Radial, ballistic shock wave treatment is a versatile method. From superficial

orthopaedic problems to myofascial trigger point treatment.

What does

enPulsProdo?

It generates shock waves by means of an ergonomic handpiece and emits

shock waves through special applicators.

With the enPulsPro, a maximum penetration depth of approx. 35 mm can be

achieved in human tissue.

How are shock waves

generated with

enPulsProdo?

Using a coil, an electromagnetic field is generated in the back end of the

handpiece.

A projectile is accelerated through the field. This crashes against the

applicator head at the front of the handpiece and generates shock waves that

spread radially in the tissues.

What are the

advantages of

enPulsPro?

The innovative technology allows for a compact design without a

compressor.

The clearly understandable colour display shows all parameters relative to

the treatment. The modern touch-screen controls and the simultaneous

connectivity of two handpieces facilitate treatment.

Individual programme start settings as well as clear and simple menu

navigation provide the user with the maximal comfort.

Different, continuously adjustable frequencies allow a treatment that is

individually suited to the particular condition of the patient.

Are there any other

advantages to using

enPulsPro?

An integrated VAS gives an

overview of the time course and outcome of the treatment.

Intended Use

enPulsPro is a treatment system for the electromagnetic generation and

application of radial shockwaves in orthopaedics and physiotherapy.

Note:

The device may only be used by healthcare professionals (e.g. physicians,

therapists, and trained medical assistants).

enPulsPro is designed and intended solely for the treatment of superficial

orthopaedic problems in humans.

Device Set-Up

6

Page 6

Note:

If the enPulsPro not mounted on the intended wagon,

ensure that the enPulsPro is placed on a stable surface.

Note:

Make sure that the power switch on the device is set to "0" .

Connect mains cable

Connect the mains cable to the corresponding socket (13) on the device and

connect the cable to the power.

Note:

The device may only be connected to earthed sockets.

Connect handpiece

Connect the handpiece to one of the sockets provided

Channel I (15) or Channel II (16) and set it down.

Note:

Make sure that an applicator head is used in the handpiece and that this is

correctly and completely screwed on.

Connect the

footswitch

Connect the footswitch to the designated socket (17), and place it on the floor.

Switching the device

on

Switch on the device with the power switch (6).

Switching the device

off

The device is switched off using the power switch (6).

In order to completely disconnect the device (all-phase) from the mains,

remove the mains cable.

Caution

!

All cables must be protected against jamming or other mechanical damage.

Settings

7

Page 7

Note:

Changes to the default settings are only possible from the start-up screen.

Start-up screen

Once the device has been switched on and the self-test performed, the home

start – up screen opens.

Note:

Pressing the "Therapy" button (1) immediately switches to the therapy screen.

Configuration menu

In the configuration menu, the factory default settings can be individually

changed and adjusted.

Selecting

Configuration

Pressing the “Settings” button (2) opens the “Settings” screen.

The setting options are described below.

By default, the factory settings are pre-programmed as shown on the screen.

1

2

4

5

6

7

2

8

1

10

11

3

9

Settings

7

Page 8

(1) Start settings

1. Start menu:

Individual options for the start settings.

The selection is made directly on the corresponding line.

(2) Language

Selection of the language.

The selection is made directly on the corresponding line.

(3) Welcome

Pressing the "Welcome" field opens a window with an alphabetic keyboard to

enter a welcome message for the start-up screen.

Pressing the “OK” key saves the text that has been entered.

Pressing the “X” key returns you to the configuration menu.

(4) OK

Pressing the key switches to the start-up screen.

(5) Version

Pressing the “Version” key opens a window with information about the current

software version.

(6) Load default

Pressing the “Load default” key restores the default factory settings.

(7) Colour scheme

Pressing the key switches between the two display settings. A bright or dark

screen can be selected.

(8) Brightness

The brightness is adjusted via the two arrow keys.

(9) Volume

The volume is adjusted via the two arrow keys.

(10) Handpiece

counter status

In this display panel, the meter reading of any connected handpiece(s) is

shown.

(11) Maintenance

After pressing the (1) key in the maintenance menu, the maintenance

message, which appears after 1.8 and 2 million collisions, can be turned off.

Deactivation results in a one-time maintenance message after 1.8 and 2

million shocks.

The maintenance message can only be deactivated by customer service.

The following points are not relevant for the user. They are used only by

customer service.

1

Operating Instructions

8.1 Device Description

8

Page 9

Handpiece

The handpiece (7) contains the shock wave generator, a fan for heat

dissipation, and the sockets for the different applicator heads. It is connected

to the control device (1).

Note:

The shockwave generator in the handpiece is a wear part and must be

replaced after a certain service life because its functionality decreases with

time.

Zimmer MedicalSysteme GmbH guarantees the unrestricted use of at least

two million shocks per shockwave generator.

Depending on power and frequency, the generator can produce far in excess

of 2 million radial pulses.

More information on the need to replace the shockwave generator is given in

Chapter 17.

To work with the handpiece on the patient, one of the applicator heads must

be screwed firmly and completely into the handpiece.

Interval operation

The handpiece is not suitable for continuous operation. As a result of the

frictional heat, the temperature of the applicator increases with increasing

duration of treatment to the extent that thermal damage to the patient cannot

be excluded.

Please refer to the chart in Chapter 9.1 for the maximum values for treatment.

After reaching the specified values, the treatment must be interrupted; it can

be resumed only after the applicator has cooled to room temperature.

Note:

Please note that the temperature control of the handpiece (described on

page 11) is only a technical shutdown to protect the mechanical parts inside

the handpiece. It does not provide information about the temperature of the

applicator head.

Recommendation:

To avoid interruption in treatments with more than 6000 shocks, the

connection of a second handpiece is recommended.

During the cooling phases, the unit can be switched to the second handpiece,

and treatment can be continued without delay.

Note:

When switching from one handpiece to another during ongoing therapy, the

pulse frequency and the number of shocks remain unchanged. The pulse

energy returns to 0 and must be reset.

Operating Instructions

8.1 Device Description

8

Page 10

Handpiece

temperature

monitoring /

regulation

The generation of mechanical impact energy generates considerable heat

within the handpiece. A temperature switch has been integrated to prevent a

reduction in the life of the handpiece. In the case of overheating, this forces

the cooling of the handpiece through an internal shutdown.

In addition to temperature monitoring, the enPulsPro regulates the

temperature using a sensor in the handpiece. The fan in the handpiece is

started when activated by the footswitch and automatically stops when it

reaches a certain temperature.

When the temperature reaches a critical limit, a cooling phase is initiated. This

is indicated in the display by the following message:

"Overheating of the applicator. Please allow the applicator to cool down. "

An output pulse is no longer possible.

After confirming the message with "OK", the treatment screen comes to the

foreground. In the selection window of the handpiece, the handpiece is shown

a deactivated. The time required for the applicator to cool down is displayed.

Applicator heads

Three different applicator heads are available for the treatment.

Changing the

applicator heads

To change the applicator head, hold the handpiece with one hand and turn the

applicator head anti-clockwise with the other hand. Turn the desired head

clockwise until it stops.

Note:

The applicator heads are wear parts and must be replaced after a certain

operating life (see Chapter 14.2 Maintenance).

Footswitch

Place the footswitch in such a way that it can be easily reached during the

treatment. The operating element of the switch is independent of direction; a

precise alignment of the footswitch is therefore unnecessary.

To avoid damage, ensure that only slight pressure is exerted on the switch.

The operation is done with the forefoot and not the heel.

The switch does not have any lock i.e. the activation remains only as long as

pressure is applied to the switch.

Operating Instructions

8.2 Notes on Operation

8

Page 11

Treatment

Please hold the handpiece as shown in the picture below.

The enPulsPro uses mechanical energy, which is transferred to the patient via

a handpiece.

In order to achieve this, the handpiece with the applicator head is placed

perpendicular to the treatment area or the point of treatment.

While applying shockwaves, it is possible to work either with the handpiece

stationary on one point, or dynamically, across a whole area.

In order to reduce friction on the skin, the use of the enPuls lotion provided is

recommended.

Due to the weight of the handpiece, it is usually not normally necessary to

press down firmly on the treatment area / point.

The handpiece is applied and held in position with the hand in a relaxed

posture.

If required, pressure can also be applied in the direction of the tissue and the

angle of use can be varied.

Caution

!

When using the enPuls Lotion or other lubricant, the applicator must be

covered with the protective silicone cap.

Note:

Despite high internal attenuation through the weight and construction of the

handpiece, the hand of the user can be strained through vibrations.

Recommended precautions:

- Limitation of the exposure time

- Passive support

Note:

During treatment, the patient should be carefully monitored.

Operating Instructions

8.3 Performing the Treatment

8

Page 12

Note:

All buttons, menus, and sub-menus can be activated directly on the screen by

finger pressure.

Program start-up

Pressing the "Therapy" button on the start screen opens the therapy screen.

Select applicator

Select an applicator to suit your desired treatment and screw it correctly into

the handpiece.

Attach

handpiece/applicator

Place the handpiece on the selected treatment point/area. To prevent friction

on the skin, the enPulse Lotion can be applied to the treatment area before

treatment.

Caution

!

When using lubricants, the applicator must be covered with the protective

silicone cap.

Set pulse energy

Set the pulse energy using the left controller.

Note:

The enPulsPro offers two methods of pulse emission.

Pulse emission with pre-set number of pulses

For pulse emission with pre-set number of pulses, the treatment is terminated

by the device after the pre-set number of pulses has been emitted.

The footswitch is deactivated and the emission of pulses is no longer possible.

Treatment can be continued by resetting the current pulse rate or by adjusting

the pre-set.

Pulse emission without pre-setting the number of pulses

With pulse output without pre-setting the number of pulses, the treatment is not

terminated by the device. Pulses are emitted as long as the footswitch is

activated.

For pulse emission without pre-set, only the ascending counting direction is

active.

Start of treatment

The treatment starts once the footswitch has been activated.

Note:

The shockwave should be activated via the footswitch only after placing the

handpiece on the patient.

End of treatment

By de-activating the footswitch, the treatment is interrupted or terminated.

Note:

During the treatment, the patient must be monitored carefully. If any issues

arise, the treatment should be adjusted or terminated.

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Zimmer enPulsPro Instructions For Use Manual

Zimmer enPulsPro Instructions For Use Manual

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