Zimmer enPulsPro Instructions For Use Manual

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Page 1

Instructions for Use

enPulsPro

Page 2

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

11 1 9

Page 3

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

Page 4

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

Switches to the VAS evaluation Switches to protocols

(E) Programs

Switches to the program list

(F) Favorites

Switches to the favorites area

E D C

Page 5

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

Page 6

Explanation of Symbols

In the instructions for us e, this symbol indicates danger.

Caution!

In the instructions for us e, 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

Page 7

Contents

Illustrations

Front of the device Rear of the device Screens / Displays

Applicator heads and accessories

Explanation of Symbols

Page

Indications / Contraindications 1

Side Effects 2

Application Information 3

Warnings 4

enPulsPro – in brief 5

Device Set-Up 6

Settings 7

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

Technical Information

9.1 Info-Chart Duration of Treatment

25 27

Cleaning / Disinfection 28

Page 8

Contents

CE mark 31

Scope of Delivery and Accessories 32

Device Combinations 33

Safety and Maintenance

14.1 Safety

14.2 Maintenance

34 35

Functional test 36

Safety Check / Metrological Control 37

Error Messages / Troubleshooting/ Disposal 38

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.

Page 9

Indications / Contraindications

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 sensibilit y

• with severe autonomic disorders

• under the influence of drugs and/or alcohol

as circulatory stresses and inadequate treatment responses cannot be excluded.

Page 10

Side Effects

Page 2

Side Effects

Treatments with the enPulsPro may occasionally cause irritation, petechiae, haematoma, swelling, or pain.

Page 11

Application Information

Page 3

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

the operating instructions and individual treatment methods to be us ed 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).

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Warnings

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 a nd 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.

Page 13

enPulsPro – in brief

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.

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Device Set-Up

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.

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Settings

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 t he 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 set t ings are pre-programmed as shown on the screen.

2 4 5 6 7

2 8 1

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Settings

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.

Page 17

Operating Instructions

8.1 Device Description

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 hand pi ece 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.

Page 18

Operating Instructions

8.1 Device Description

Page 10

Handpiece

temperature monitoring / regulation

The generation of mechanic al impac t ener gy ge ner ates 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 m oni tor ing, the enPul s Pro 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, hol d 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.

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Operating Instructions

8.2 Notes on Operation

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.

Page 20

Operating Instructions

8.3 Performing the Treatment

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 tr ea t m ent poi n t/ar e a. 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 pr e-s et, onl y th e asc en di ng counting direction is

active.

Start of treatment

The treatment starts once t he foots wi tc h 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.

Page 21

Operating Instructions

8.4 Display and Buttons

Page 13

Description of the

display elements and buttons

(1) Pulse energy

Displays the set pulse energy. In the case of active treatment, the bar graph is

filled in. The pulse energy can be set before and during the emission of pulses.

The pulse energy can be adjusted from 60 to 185 mJ in 10 mJ increments.

(2) Selection of

handpiece

Connecting one handpiece:

If only one handpiece is connected, the channel of the connected handpiece is shown in the selection window. The handpiece is activated automatically regardless of the connected channel.

Connection of two handpieces: If two handpieces are connected, the handpiece on Channel I is initially activated.

The desired handpiece can be activated by directly selecting the handpiece in

the selection window. The activated handpiece is highlighted.

(3) VAS Pre

Activating the VAS Pre window opens the screen to measure the subjective sensation of pain prior to the treatment.

(4) VAS Post

Activating the VAS Post window opens the screen to measure the subjective sensation of pain following the treatment.

The precise procedure for this measurement is described in detail in Chapter

8.8.

2 3 4 5 6 7 10 8 12

Page 22

Operating Instructions

8.4 Display and Buttons

Page 14

(5) Mode

Displays the selected mode. Upon activation of the window, the selection menu

with the operating modes is displayed: Series Pulse, Burst 4 Pulse, Burst 8 Pulse, Burst 12 Pulse.

The desired mode of operation is selected directly on the corresponding line.

(6) Frequency

Displays the set frequency.

Frequency range: 1–22 Hz, adjustable via the actuator on the right. The

maximum selectable frequency is dependent on the set power level.

(7) Saving

Pressing the key opens the field to enter the individual name of a program. The program is automatically stored in the favourites list.

(8) Counting

direction

Pressing the key sets the counting direction (ascending or descending) of the number of pulses emitted.

(9) Pulse count

Display of the preselected number of pulses and the currently emitted pulses

as well as the total number of pulses emitted in the case of non pre-set pulse number. Ascending or descending display the counting direction. Activating the pulse number window opens the entry menu for entering

a pre-selected number of pulses. The pre-set is done in increments of 100.

(10) Reset

For ascending counting direction, this resets to 0; for descending counting direction, this resets to the pre-set number of pulses.

(11) Information

Pressing the key returns to the treatment and treatment information.

(12) Status line

Displays the name of the currently selected program.

Page 23

Operating Instructions

8.5 SD card

Page 15

SD card

User-defined settings and the list of indications are saved on the SD card.

If the SD card is not inserted, the following message appears after pressing

the "Favourites" and "VAS" k eys : “SD card was not found”. The use of "Favourites" and "VAS" requires an SD card.

Insert the card and confirm with "OK".

Note:

Disable the message as described in Chapter 17

Page 24

Operating Instructions

8.6 Protocols

Page 16

The “Protocols” menu helps users to select the appropriate treatment.

Protocols

Pressing the (1) key opens the menu with the "treatment recommendations".

Note:

In the "Protocols" menu there are two ways to choose the desired treatment:

- via the body region

- via the list

Treatment selection

via body region

The body region is selected by clicking the black square.

Select body region

After selecting the desired body region (in this case the elbow), the window for

treatment recommendations in the elbow area opens.

The disease is selected directly on the corresponding line.

Note:

Regardless of whether the indication is selected via body region or list, the

program steps from here up to the treatment screen are analogous and are

therefore only described once below.

Page 25

Operating Instructions

8.6 Protocols

Page 17

Select differentiated

state of the disease

The differentiated state of the disease is selected directly on the

corresponding line (here: acute).

Treatment information

After selecting the differentiated disease, another window with detailed

treatment and treatment information opens. Pressing the (2) key opens additional treatment and treatment information. Key (3) switches back to the previous information.

Select treatment program

Pressing the (1) key opens the screen with the corresponding treatment program.

1 2 3

Page 26

Operating Instructions

8.7 Favourites List – Retrieving Programs and Editing Lists

Page 18

The parameters of the pre-defined programs can be individually modified and saved.

Saving and naming

the program

Pressing the "Save" button opens the field for entering the program name.

The program name is entered via the keyboard.

Note:

There are 120 memory locations available for each.

Saving to the

Favourites list

Pressing the (1) key opens the favourites list and automatically saves the

program to the list. The program is always saved to the first available space of the list.

Pressing the (2) key cancels the saving process.

Note:

If the (1) key is pushed without entering a program name, the following

message will appear: “Please enter a name!” Confirm the message, enter the program name, and repeat the saving

process.

Page 27

Operating Instructions

8.7 Favourites List – Retrieving Programs and Editing Lists

Page 19

The individually saved programs are listed in the favourites list.

These can be

1. retrieved for treatment

2. edited (shifted in the sequence and deleted).

Select favourites list

Pressing the “Favourites” button opens the favourites list.

Retrieve program

The desired program is selected directly in the corresponding row.

Edit favourites list

Pressing the (1) key opens the “Edit favourites” screen.

Page 28

Operating Instructions

8.7 Favourites List – Retrieving Programs and Editing Lists

Page 20

Edit favourites

Pressing the (1) key returns you to the program. Pressing the (2) key moves the program upward. Pressing the (3) key moves the program downward. Pressing the (4) key deletes the program.

Pressing the (5) key confirms the editing.

Note:

Pressing the (4) key triggers a security query:

“Are you sure you want to delete this program?” Pressing the “Yes” key deletes the program.

Pressing the “No” key cancels the operation.

Page 29

Operating Instructions

8.8 VAS – Visual Analogue Scale

Page 21

Information on VAS

The enPulsPro features a visual analogue scale, or pain scale. The pain scale

is often used when treating pain. The pain scale is used to measure the subjective pain intensity of the patient.

The patients rate the current pain on a scale of 0–10, whereby 0 = "no pain" and 10 = "worst pain imaginable".

The measurement is carried out before and after each treatment. With repeated documentation, this method gives a preliminary overview of the

temporal progress and success of a treatment.

VAS list

Activating the "VAS-Pre" / "VAS-Post" field in the therapy screen opens the

"VAS" screen. In the VAS list,

1. New patients are entered for measurements

2. Already existing patients are called up for further measurement

3. Data is edited (the sequence altered or entries deleted)

Pressing button (1) opens the field for entering the patient's nam e.

Pressing button (2) interrupts the procedure and returns to the therapy screen.

Page 30

Operating Instructions

8.8 VAS – Visual Analogue Scale

Page 22

Editing the VAS list

Pressing button (3) as well as button (4) and selecting the program to be edited directly in the corresponding row opens the screen for editing the data. Pressing the "Delet e" but t o n del etes the pr ogr am . Pressing the "Scroll" arrow keys moves the program one place up or down. Pressing buttons (5) and (6) scrolls forwards and backwards through the pages

of the VAS list.

Enter new patient

Activating the "VAS Pre" field in the treatment screen opens the VAS screen.

The "New" button opens the field for entering the patient's name.

Enter the name of the patient. By pressing the (1) key, the data is accepted, and the screen with the pain scale opens automatically.

The button(2) cancels the operation.

Performing

VAS Pre

The patient marks his current pain sensation on the scale from 0 – 10 before therapy. This is accepted and shown on the scale by a blue arrow and is saved

automatically. Pressing the button (1) switches back to the therapy screen.

Page 31

Operating Instructions

8.8 VAS – Visual Analogue Scale

Page 23

Perform VAS Post

The pain sensation after treatment is establishes by activating the "VAS Post" field.

Note:

"VAS Post“ is identical to "VAS Pre“ and is therefore not described again.

Repeating

measurement

Existing patients are activated in the VAS list directly on the corresponding line.

After activating the line, the screen with the pain scale automatically opens for

a new measurement.

Note:

Up to 40 measurements can be saved per patient.

Once this number has been reached, the following message appears:

"The maximum number of measurements that can be saved per patient

has been reached. A maximum of 40 measurements can be stored". To be able to perform more measurements on this patient, t he pati e nt must be

entered again.

Pressing the "OK" key closes the information window with the message.

Evaluation of VAS

By pressing the "Evaluation" button in the navigation bar, the treatment of the

individual patient can be accessed in the VAS list. The patient is selected directly on the corresponding line. After activating the

line, the screen with the progression curve of the treatment opens automatically.

Page 32

Operating Instructions

8.8 VAS – Visual Analogue Scale

Page 24

Table

Pressing button (1) also displays the therapy progress in tabular form.

Page 33

Technical Information

Page 25

Basic unit

Power supply

100 – 240 V/ 50/60 Hz; 220 V/60 Hz

Fuse

2 × T3A15L, 250 V

Power consumption

250 VA

Protection class

Application class

Application part

Applicator head

Silicone protection cap

Frequency range

1 – 22 Hz, adjustable in 1 Hz increments

3 burst modes with 4, 8 or 12 pulses

Pulse energy levels

60 – 185 mJ (at the applicator), freely adjustable in 10 mJ increments

at 22 Hz max. 90 mJ at 16 Hz max. 120 mJ

at 10 Hz max. 185 mJ

Operating mode

Interval operation

Accuracy

± 20%

Dimensions

enPulsPro with SysCart

H 138 cm × W 53 cm × L 52 cm

enPulsPro

H 30 cm × W 35 cm × L 20 cm

SysCart

H 109 cm × W 53 cm × L 52 cm

Weight of

enPulsPro with SysCart

19.3 kg

enPulsPro

3.8 kg

SysCart

15.5 kg

IP class

IPX0 Device

IPX5 Footswitch

IPX0 Handpiece

Operation

10 – 25°C, 20 – 80% relative humidity, non-condensing at 700–1060 hPa

Storage/ Transport

-10 – 50°C, 10 – 90% relative humidity, non-condensing at 700 – 1060 hPa

Page 34

Technical Information

Page 26

Handpiece enPuls (Version 2.2)

Dimensions

230 mm long, 50 mm diameter

Weight

850 g

Lifetime

2,000,000 shocks (shockwave generator)

Applicator heads

6/15/25 mm Diameter can be changed without tools 150,000 shocks guaranteed

Handpiece ZWave (version 2.2)

Dimensions

230 mm long, 50 mm diameter

Weight

850 g

Lifetime

2,000,000 shocks (shockwave generator)

Applicator heads

39 mm Diameter; can be ch anged without tools 150,000 shocks guaranteed

Note:

Storage and transport only in original packaging.

Subject to technical changes.

Page 35

Technical Information

9.1 Info-Chart Duration of Treatment

Page 27

Maximum shocks per treatment

Frequency (Hz)

Shocks

Page 36

Cleaning

Desinfection

Page 28

- Before starting any maintenance and cleaning measures the device must

always be switched off at the main switch and the mains cable unplugged.

- Make sure that when cleaning and disinfecting the labels of the device (such as warnings, labels of control devices, identification plate) are not damaged.

- Make sure that during cleaning and disinfection no liquids penetrate the device. Do not use sprays.

- If during cleaning or disinfecting liquid penetrates the device, please put the unit out of service, protect it from being used again and contact your service representative.

- In order to minimize the risk of infections do always wear protective gloves for cleaning and disinfection.

- The device and its applied part are not considered critical in relation to hygiene when used on non-injured and healthy skin (see for example RKI-

Guideline).

Housing /

Foot switch

Cleaning (only manually)

Tools:

 Disposable wipes (cellulose, paper)  Alcohol-free plastic cleaner (e.g. cleaner for medical devices)

In case of visible contaminations the housing, foot switch and the tubing can be cleaned with commercially available alcohol-free plasti c cleaners. Wipe the surface until the contamination is removed, using a soft cloth soaked according to the specifications of the manuf acturer of the cleaning agent but not dripping wet.

Disinfection (only manually):

Tools:

 Disposable wipes (cellulose, paper)  Commercially available alcohol-free disinfectant for metal and plastic, with

bactericidal, virucidal and fungicidal properties or wipes. Observe the application instructions of the manufacturer.

We recommend that disinfection is to be carried out at least once a week, as well as if there is any indication of contamination. Consult with your hygiene specialist when doing so. Always perform cleaning prior to disinfection.

Housing and foot switch can be disinfected by wiping. Use a commercially available alcohol-free disinfectant for metal and plastic, with bactericidal, virucidal and fungicidal properties. Observe the applica ti on instr uc t ions of the manufacturer. Wipe all surfaces using a cloth soaked according to the specifications of the manufacturer of the disinfectant, but not dripping, or with cloth pre-impregnated with disinfectant (wipes).

If applicable, also observe requirements for drying or post-cleaning.

Page 37

Cleaning

Desinfection

Page 29

Applicator head /

handpiece

Cleaning (only manually)

Tools:

 Disposable wipes (cellulose, paper)  Alcohol-free plastic cleaner (e.g. cleaner for medical devices)

Remove the silicon protective cap from the applicator head before cleaning. Then proceed as indicated under “housing / foot switch”.

Disinfection (only manually):

Tools:

 Disposable wipes (cellulose, paper)  Commercially available alcohol-free disinfectant for metal and plastic, with

bactericidal, virucidal and fungicidal properties or wipes.

Then proceed as indicated under “housing / foot switch”.

Silicon protective

cap

Cleaning (only manually)

Tools:

 Drinking water, lukewarm  Vessel, e.g. kidney dish  Brush, e.g. tooth brush medium hard  Alcohol-free plastic cleaner (e.g. cleaner for medical devices)

Remove the silicon protective cap from the applicator head before cleaning. Prepare a solution of the cleaning agent following the instructions of the manufacturer. Put the silicon protective cap into the solution. Clean the inner and outer surfaces of the protective cap by using the brush. Rinse off the protection cap under running water.

Disinfection, manually:

Tools:

 Vessel, e.g. kidney dish  Commercially available alcohol-free disinfectant for metal and plastic, with

bactericidal, virucidal and fungicidal properties or wipes.

Prepare a solution of the disinfection agent following the instructions of the

manufacturer. Put the silicon protective cap into the solution. Make sure that

Page 38

Cleaning

Desinfection

Page 30

the inner and outer surfaces of the protective are wetted. Leave the protective

cape in the solution as long as defined by the manufacturer of the disinfection agent. Rinse off the protection cap under running water.

Cleaning / Disinfection, by machine: Preparation:

Visible contaminations must be removed by manually before performing cleaning / disinfection. Proceed as described above.

Performance:

Perform a cleaning and disinfection by machine using the following parameters:

 Cleaning agent: neodisher® MediClean forte (manufacturer: Dr. Weigert)  Cleaning: 10 minutes at 55°C

 Disinfection: 5 minutes at 93°C

Caution: If flammable solutions are used for cleaning and disinfecting,

sufficient time must be allowed for the solution to evaporation before using the

device. Otherwise, it may lead to inflammation.

Suitable Disinfection

agents

For manual disinfection, the following agents are suitable:

 mikrozid® sensitiv wipes  Antifect FF  Gigasept FF  Quartamon Med

Observe the application information of the corresponding manufacturer.

Note:

Only use the device in a completely hygienic environment.

Caution!

When using lubricants, the silicone protection cap must be placed over the

applicator head in order to avoid contamination. If the device is used without the cap, lubricant may enter the interior of the applicator head and the handpiece, which can lead to permanent

contamination and malfunction.

Note:

In this case, the warranty is null and void.

Page 39

CE mark

Page 31

The product bears the CE mark

in accordance with EC directive 93/42/EEC concerning medical devices.

Page 40

Scope of delivery

Accessories

Page 32

Scope of delivery in combination with SysCart

ItemNo.

5430

1 enPulsPro controller unit

9160

1 SysCart with tray mount

5413

1 Handpiece (version 2.2)

93133521

1 Applicator head, 6 mm

93133511

1 Applicator head, 15 mm

93133502

1 Applicator head, 25 mm

65135110

10 Silicone protection caps

50500038

1 enPulse lotion

94130411

1 Footswitch

65410410

1 Storage tray for accessories

117

1 Mains cable

10102382

1 Instructions for use

63061010

1 Template

Scope of delivery Table device

ItemNo.

5430

1 enPulsPro controller unit

5413

1 Handpiece (version 2.2)

93133521

1 6 mm applicator head

93133511

1 15 mm applicator head

93133502

1 25 mm applicator head

65135110

10 Protective silicone caps

50500038

1 enPulse lotion

94130411

1 Footswitch

65410410

1 Storage tray for accessories

117

1 Mains cable

65410110

1 Holder for handpiece

63061010

1 Template

10102382

1 Instructions for use

Accessories

ItemNo.

5413

Handpiece enPuls (version 2.2)

5411

Handpiece ZWave (version 2.2)

93130312

Holder for handpiece enPuls

93130411

Holder for handpiece ZWave

93133521

Applicator head, 6 mm

93133511

Applicator head, 15 mm

93133502

Applicator head, 25 mm

93133530

Applicator head, 39 mm for ZWavePro

65135110

Silicone protection cap

50500038

enPuls lotion

94130411

Footswitch

93410210

Holder for footswitch

65410410

Storage tray accessory

67250131

Mains cable

Page 41

Device Combinations

Page 33

For enPulsPro no combinations devices are provided by the manufacturer.

Anyone who, acting contrary to this specification, combines devices and thus operates a medical system does so at their own risk.

Page 42

Safety and Maintenance

14.1 Safety

Page 34

The enPulsPro is manufactured in accordance with the DIN EN 60601-1 safety

regulations. Zimmer MedizinSysteme GmbH shall only be held responsible for the safety

and reliability of the device if

• the device is operated using a proper power outlet with earth contact and the electrical installation complies with DIN VDE 0100 part 710,

• the device is operated in accordance with the operatinginstructions,

• extensions, readjustments, or modifications are only performed by persons

authorised by Zimmer MedizinSysteme GmbH,

• the user has been instructed in the functional safety, proper operating condition, and the mechanical integrity of the device and handpiece prior to use,

• the device is only operated by properly trained personnel,

• the device is not operated in hazardous areas and/or a combustive

atmosphere,

• the device is immediately disconnected from the power supply upon the penetration of liquid.

The device contains no parts that can be maintained or repaired by the

operator.

Modification of this device is not permitted.

Service and replacement of components may only be performed by certified

service technicians from Zimmer MedizinSysteme GmbH.

Page 43

Safety and Maintenance

14.2 Maintenance

Page 35

Before commencing cleaning and maintenance, the machine must always be switched off at the main switch and the mains socket.

Checking the impact

dome

During the course of normal use, a deformation / shortening of the rear impact

dome on the applicator heads may occur. As long as the changes are small, functionality is not affected.

In cases of more extensive deformation of the impact dome or considerable shortening, the applicator head must be replaced.

To check the proper condition of the applicator head, a test template is supplied with the device in order to test whether the wear limit has been reached.

The test should be performed at least once a month, regardless of the frequency of use.

To do so, the applicator head is removed and measured using the test

template supplied.

Test template

Air gap  Applicator OK

Template sits flush or there is an air gap at the top  Wear limit reached

Page 44

Functional Test

Page 36

enPulsPro performs a self-test when switched on checking all the internal

components. In the event of a fault, an error message ap pears . In addition, a further function test can be performed as described below.

This test should be performed monthly or in case of doubt about the proper function of the device.

Note:

Before performing the function test, check that the handpiece and footswitch

are properly connected to the device. Check that the mains cable is properly connected to the device and that it is

connected to the mains.

Function test

Switch the device on.

Briefly activate the footswitch - the fans and generator should start immediately, whereby the radial pulse generator must operate at the frequency

shown on the display (5 Hz is the default value).

Note:

After completing the function tests, switch off the enPulsPro.

If a therapy is to be carried out directly afterwards, set the desired treatment

parameters and proceed as described in Chapter 8.

Page 45

Safety Check

Metrological Control

Page 37

Neither a safety check (STK) nor a metrological control (MTK) is required for

the device enPulsPro in Germany. In Germany, the MPBetreibV (Medical Devices Operator Ordinance) and the

DGUV (Regulation 3 – Electrical systems and equipment) apply in their current

versions.

Note:

These requirements apply to the operation of the device in Germany. Please observe the national regulations in your country.

Page 46

Error Messages

Troubleshooting

Disposal

Page 38

Loss of function

handpiece

In the status bar the message "Ready" appears and no pulse is triggered in

spite of activating the footswitch

Possible cause 1

Handpiece/footswitch not properly connected or defective. Remedy for cause 1: Make sure that the footswitch and handpiece are correctly connected. The plugs must be fully inserted. Check the cable of the footswitch for damage or kinks. In the case of visible damage, replace the footswitch. Check whether the dome of the footswitch can be moved or is blocked. Remedy the blockage if possible.

Possible cause 2

Program settings incorrect. Remedy for cause 2

Check whether the pulse energy is set, and if not, set it.

Handpiece

malfunction

Irregular emission of the shockwaves / excessive heating of the handpiece

Possible cause 1

Wear to the applicator head / restricted movement due to wear. Remedy for cause 1: The applicator heads are wear parts and must be replaced after a certain number of pulses.

Removal of wear parts: Remove the applicator head from the handpiece and thoroughly clean the rear dome. Then hold the handpiece without applicator head with the opening facing downwards. With the frequency set to 2 or 5 Hz at the lowest energy level, trigger a small number of shocks (maximum 10). Then attach the applicator head again. If the malfunction still occurs, the applicator head must be replaced.

Possible cause 2:

Wear of shock wave generator

Remedy for cause 2:

The shockwave generator is a wear part and should be replaced after two million shocks. Check the total number of pulses of the device in the configuration menu. If the total number of pulses of two million has been reached or exceeded, the shock wave generator must be replaced. To replace the shockwave generator, please contact your sales representative or the headquarters in Neu-Ulm.

Page 47

Error Messages

Troubleshooting

Disposal

Page 39

Applicator not found

In the status line, the message "No applicator found" appears.

Possible cause

Handpiece not or improperly connected.

Remedy for cause

Make sure that the handpiece is properly connected. The plug must be fully

inserted.

Device malfunction

No response to the main switch / display remains dark.

Possible cause 1

Mains power connection

Remedy for cause 1:

Check whether the mains cable is properly plugged into the electrical outlet and that the device connector is firmly inserted into the socket of the device. Check the mains cable for damage. Replace it in the event of visible damage. Check the power supply and mains socket.

Possible cause 2:

Fuse

Remedy for cause 2:

In the power supply socket of the device, there are micro-fuses that disconnect the power supply in the event of an elect ri c al pr obl em . Open the cover and

check the fuses. If necessary, replace the faulty fuse.

Only replace the fuse with a replacement that has the same name / is an exact

equivalent. Perform a complete check of the power supply for possible faults beforehand.

If the fault persists, contact the service representative / customer service

immediately.

Page 48

Error Messages

Troubleshooting

Disposal

Page 40

Error message

SD card

If the SD card is not inserted, the following message appears after pressing the

"Favourites" and "VAS" keys: “SD card was not found”.

The use of "Favourites" and "VAS" requires an SD card.

Insert the card and confirm with "OK".

Over temperature

warning

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

is indicated in the display by the following m ess ag e: "Over temperature in the applicator. Please allow the applicator to cool down." When this message appears, pulse input is no longer possible. After confirming the message with "OK", the therapy screen moves to the

foreground with the message in the status bar when the handpiece returns to

operating temperature.

In the case of other malfunctions, switch the device off and then on again after

a 5-second delay. If the error is still present, please inform customer service via

the headquarters in Neu-Ulm.

Headquarter

Zimmer MedizinSysteme GmbH

Junkersstraße 9 D-89231 Neu-Ulm Tel: 0731. 9761-0 Fax: +49 731. 9761-118

www.zimmer.de

Disposal

The device may only be returned to the factory in its original packaging. It must

only be disposed of via the factory in Neu-Ulm. In foreign (European) countries please refer to national regulations for disposal.

Contact your distributor if necessary.

Page 49

Manufacturer’s EMC Declaration

Page 41

Medical devices such as the enPulsProare subject to special precautions with respect to electromagnetic compatibility (EMC) and must be installed and operated according to the user manual or the EMC instructions included with the device.

Portable and mobile RF communications equipment (such as mobile telephones) can affect electrical medical devices. The enPulsPro may only be used with the original parts specified in the delivery list.

The operation of the device with another power cord may result in increased emissions or decreased resistance of the device!

Guidelines and manufacturer’s declaration – electromagnetic interference emissions

The enPulsPro is intended for use in one of the electromagnetic environments specified below. The customer or the user of the enPulsPro should ensure that it is only used in such an environment.

Interference emission measurements

Accordance

Electromagnetic environment – guidelines

RF emissions in accordance with CISPR 11

Group 1

The enPulsPro uses RF energy for its internal

function only. The RF emissions are therefore extremely low and are not likely to cause any

interference in nearby electronic equipment.

RF emissions in accordance with CISPR 11

Class B

The enPulsPro is suitable for use in all

establishments including those in residential areas and those directly connected to the public supply network that supplies residential buildings.

Emissions of harmonic oscillations in accordance with IEC 61000-3-2

Class A

Emissions of voltage fluctuations/flickers in accordance with IEC 61000-3-3

Conforms with

The device must not be used immediately next to or stacked directly on top of other devices. If it must be used in the vicinity of or stacked directly on top of other devices, the device should be monitored to verify that it is operating properly in this configuration.

Page 50

Manufacturer’s EMC Declaration

Page 42

Guidelines and manufacturer’s declaration – electromagnetic interference resistance

The enPulsPro is intended for use in one of the electromagnetic environments specified below. The customer or user of the enPulsPro should ensure that it is only used in such an environment.

Interference checks

IEC 60601 – test level

Compliance level

Electromagnetic environment – guidelines

Electrostatic discharge

(ESD) in accordance with IEC 61000-4-2

±6 kV contact discharge

±8 kV air discharge

±6 kV contact discharge

±8 kV air discharge

Floors should be made of wood,

concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity

should be at least 30%.

Fast transient electrical

disturbances/bursts in accordance with IEC 61000-4-4

± 2kV for power supply

lines ±1 kV for input and output

lines

± 2kV for power supply

lines Not applicable for input

and output lines

The quality of the supply voltage

should correspond to that of a typical commercial or hospital environment.

Impulse voltages (surges)

in accordance with IEC 6100-4-5

± 1 kV Normal mode

voltage ± 2 kV Common mode

voltage

± 1 kV Normal mode

voltage ± 2 kV Common mode

voltage

The quality of the supply voltage

should correspond to that of a typical commercial or hospital environment.

Voltage dips, short

interruptions, and voltage variations in accordance with IEC 61000-4-11

< 5% UT

(> 95% dip in UT for ½ period)

40% U

(60% dip in U

for 5

periods) 70% U

(30% dip in U

for 25

periods) < 5% U

(> 95% dip in U

for 5

seconds)

< 5% UT

(> 95% dip in UT for ½ period)

40% U

(60% dip in U

for 5

periods) 70% U

(30% dip in U

for 25

periods) < 5% U

(> 95% dip in U

for 5

seconds)

The quality of the power supply

should correspond to that of a typical commercial or hospital environment. If the user of the enPulsPro wishes to continue operation even after the energy supply is interrupted, it is recommended that the enPulsPro be connected to an uninterruptible power supply (UPS) or battery.

Magnetic field of the supply

frequency (50/60 Hz) in accordance with IEC

61000-4-8

3 A/m

Magnetic fields at the power

frequency should correspond to the typical values of a commercial

or hospital environment.

Note: UT is the AC power voltage prior to application of the test level.

Page 51

Manufacturer’s EMC Declaration

Page 43

The main features of the enPulsPro are: the trouble-free delivery of shockwaves and operation of all functions. Uninterrupted operation is not required for the intended application.

Guidelines and manufacturer’s declaration – electromagnetic interference resistance

The enPulsPro is intended for use in one of the electromagnetic environments specified below. The customer or user of the enPulsPro should ensure that it is only used in such an environment.

Interference tests

IEC 60601 test level

Conformity level

Electromagnetic environment – guidelines

Conducted

RF interference in accordance with IEC 61000-4-6

Radiated RF disturbance according to IEC 610004-3

3 V

RMS

150 KHz to 80 MHz

3 V/m 80 MHz to 2.5 GHz

3 V

RMS

150 KHz to 80 MHz

3 V/m 80 MHz to 2.5 GHz

Portable and mobile RF communications

equipment (including cables) should be used no closer to the

enPulsPro than the recommended separation distance, which is calculated according to the equation for the transmission frequency.

Recommended separation distance:

d = 1.2 √P d = 0.35 √P for 80–800 MHz d = 0.7 √P for 800 MHz to 2.5 GHz where P is the nominal rating of the transmitter in

watts (W) in accordance with the manufacturer of the transmitter and d is the recommended separation distance in metres (m).

In accordance with an on-site investigation

, for all frequencies, the field strength of a stationary radio transmitter should be less than the coincidence level

In the vicinity of devices marked with the following symbol, errors may occur:

NOTE 1: At 80 and 800 MHz, the higher frequency range applies.

NOTE 2: These guidelines may not apply in all cases. The spread of electromagnetic variables is affected by the absorption

and reflection of structures, objects, and people.

Page 52

Manufacturer’s EMC Declaration

Page 44

The field strengths of fixed transmitters e.g. base stations of mobile telephones and mobile radio devices, amateur

radio, AM and FM radio broadcasting, and TV broadcasting cannot be accurately predicted. To assess the electromagnetic environment with respect to fixed RF transmitters, an electromagnetic survey of the site should be considered. If the measured field strength in the location in which the enPulsPro is used exceeds the applicable RF compliance level, the enPulsPro should be observed in order to verify normal operation. If abnormal output is observed, additional measures may be necessary (e.g. reorienting or relocating the enPulsPro).

In the frequency range of 150 kHz to 80 MHz, the field strengths should be less than 3 V/m.

Recommended separation distances between portable and mobile RF communications equipment and the enPulsPro

The enPulsPro is intended for use in one of the electromagnetic environments specified below. The customer or the user of

the enPulsPro can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the enPulsPro – depending on the output power of the

communications equipment as specified below.

Nominal capacity of the transmitter

Protective distance dependent on the transmission frequency

150 KHz to 80 MHz

d = 1.2 √P

80–800 MHz

d = 0.35 √P

800 MHz to 2.5 GHz

d = 0.7 √P

0.01

0.12

0.035

0.07

0.1

0.38

0.11

0.22 1 1.2

0.35

0.70

3.8

1.1

2.2

100

3.5

For transmitters for which the maximum nominal output is not specified in the above table, the recommended separation distance d in

meters (m) can be determined using the equation given for the corresponding column, where P is the maximum rated power of the transmitter in watts (W) in accordance with the manufacturer of the transmitter. NOTE 1: At 80 and 800 MHz, the higher frequency range applies. NOTE 2: These guidelines may not apply in all cases. The spread of electromagnetic variables is affected by the absorption and reflection

of structures, objects, and people.

Page 53

EN 10 102 382 UR 0716 I Version 3.1 I Modications reserved

enPulsPro

Zimmer MedizinSysteme GmbH Junkersstraße 9 89231 Neu-Ulm, Germany Tel. +49 7 31. 97 61-291 Fax +49 7 31. 97 61-299 export@zimmer.de www.zimmer.de

Instructions for Use