Focus Shockwave Operating Manual Rev C Oct 2018

Table of Contents

Table of Contents

2

1

General Safety Information

7

1.1

Instructions for safe use

7

1.1.1

Intended use and operational safety

1.1.2

Safety during treatment of the patient... 9

1.2

Warning against damage to equipment and the device

9

1.3

Manufacturer‘s responsibility

11

1.4

Owner‘s responsibility

11

2

Principles

12

2.1

Physical principles

12

2.1.1

Indications... 12

2.1.2

Contraindications

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2.1.3

Side effects .

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2.2

Preconditions for operation

2.2.1

Operating personnel... 15

2.2.2

Training of the operator

3

System Description

16

3.1

Control and functional elements

16

3.2

F-SW handpiece and optional C-ACTOR handpiece

17

3.3

Use of stand-off devices

18

4

Installation Instruction

20

4.1

Scope of supply

20

4.2

Unpacking

20

4.3

Correct positioning of the device

20

4.4

Handpiece holder installation

21

4.4.1

Installing the F-SW holding arm (optionally)... 21

4.4.2

Connecting power supply cables

4.4.3

Handpiece connection... 22

4.4.4

Connecting the optional foot switch .

4.4.5

Potential equalisation (optional)... 23

4.4.6

USB connection... 23

4.5

Transport

24

4.6

Compatibility

24

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5

Operation

25

5.1

User interface

25

5.2

Overview of menu functions

29

5.3

Starting the instrument

32

5.4

Setting the treatment parameters

34

5.5

F-SW Energy display task

36

5.6

Storing the treatment parameters

37

5.7

Loading treatment parameters

39

5.7.1

Pre-programmed indications from the manufacturer... 39

5.7.2

In-house applications .

5.8

Patient record

42

5.9

Visual analogue scale (VAS)

44

5.10

Data transfer

45

5.11

Software updates

48

5.11.1

Loading the software onto the USB stick

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5.11.1.1 Extracting the software using Windows .

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5.11.2

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Extracting the software with WinZip .

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5.11.3 Updating the software on the instrument... 50 5.12

Resetting the treatment shock counter

50

5.13

“Autofrequency” function

51

5.14

Start-up

52

5.15

Functional checks

54

5.16

Standard settings

54

5.17

Treatment

55

5.18

Switching off the device

55

6

Cleaning, Maintenance and Overhaul

56

6.1

Cleaning the device

56

6.2

Cleaning the handpiece

57

6.2.1

Changing the stand-off device... 57

6.2.2

Reprocessing of the handpiece and the stand-off devices

6.2.2.1

Cleaning... 58

6.2.2.2

Disinfection

6.3

Cleaning the optional foot switch

59

6.4

Water renewal

60

6.4.1

Draining the water circuit... 60

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Table of Contents

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Table of Contents

4

6.4.2

Filling the water circuit

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6.4.3

Bleeding the water circuit... 64

6.4.4

Resetting the water renewal time... 64

6.5

Fuse replacement

65

6.6 Maintenance and safety checks

65

6.7

Disposal

66

6.8

Repair

66

6.9

Service life

66

7

Status messages and trouble-shooting

67

7.1

Status messages

67

7.2

Trouble-shooting

69

8

Accessories

70

9

Technical Specifications

71

9.1

Technical Specifications

71

9.2

Type plate Chattanooga Intelect F-SW

75

9.3

Conformity with directives

75

9.4

Conformity with standards

75

9.5

Certificates

80

9.6

Symbols and labels

81

10

Warranty and Service

84

10.1

Warranty for the control device

84

10.2

Warranty for the F-SW handpiece and the C-ACTOR Handpiece

85

10.3

Service

85

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Preface Warning notes This manual contains warnings, safety instructions and specific operating instructions in accordance with liability regulations. DANGER refers to a situation of acute danger which, if not avoided, could lead to serious or fatal injury.

DANGER! The source of the danger is stated here. These are the possible consequences! • The instructions for avoiding the danger are given here. WARNING refers to a situation of potential danger which, if not avoided, could lead to serious injury.

WARNING! The source of the danger is stated here. These are the possible consequences! • The instructions for avoiding the danger are given here.

CAUTION indicates that incorrect operation could lead to minor injuries.

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CAUTION! The source of the danger is stated here. These are the possible consequences! • The instructions for avoiding the danger are given here. ATTENTION indicates that incorrect operation could lead to damage to the device.

ATTENTION! The source of the danger is stated here. These are the possible consequences! • The instructions for avoiding the danger are given here. Other instructions

Additional information concerning specific features or operating instructions is preceded by the term 'NOTE'.

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Preface

NOTE

Safety signs and other symbols used in this manual Symbol

Name General warning sign

Electrical warning sign

Wear hearing protection!

WEEE (waste electrical and electronic equipment)

Device serial number

CE mark

Electromagnetic interference may occur in the vicinity of instruments marked with this symbol. Table 1-1

Preface

6

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1

General Safety Information

1.1

Instructions for safe use The following chapter contains all safety information that has to be followed when working with the Chattanooga Intelect F-SW.

WARNING! Incorrect handling of the device. Possibility of injuries to the patient and the operating personnel! • Read this chapter carefully before you start using the Chattanooga Intelect F-SW. • Read the separate operating manuals for all devices associated with the Chattanooga Intelect F-SW.

1.1.1

Intended use and operational safety To use this device in accordance with its intended use, the user must possess the necessary technical proficiency, and knowledge of the operating manual. The Chattanooga Intelect F-SW is intended exclusively for use by healthcare professionals who have been trained to use the device (see also chapter 2.2 Preconditions for operation). The device is only allowed to be used for the applications described in Chapter 2.1.1 Indications.

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Only perform treatments approved by the manufacturer! Furthermore, the device is only allowed to be operated by trained personnel who comply with the Preconditions for operation in Chapter 2.2. All status and error messages signaled during treatment must always be attended to without delay.

Checks and inspections prior to treatment Before using the device, the user must make sure it is functioning safely and that it is in proper condition. • It is essential to perform the functional checks after switching on the Chattanooga Intelect F-SW before starting treatment. Read about this in Chapter 5.15 Functional checks. • Have the maintenance procedures recommended by the manufacturer carried out by authorised personnel (see also Chapter 6.6 Maintenance and safety checks). No treatment ist permitted if a display on the control device or a touch screen fails.

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General Safety Information

While applying focused shockwaves at maximum adjustment, do not use more than 6.000 subsequent shocks and stick to a consecutive break of 5 minutes.

Protection against electrical hazard Sources of voltage can give rise to currents as a result of body resistance which not only flow through the patient but can also impair or even endanger the physician and the nursing staff. • Therefore, always connect the potential equalisation connector of the Chattanooga Intelect F-SW in accordance with national guidelines. • Devices which are not medical products in accordance with EN 60601 must be set up outside the vicinity of the patient. • Do not touch electrical connectors while you are touching the patient. • Disconnect the connected handpieces from the device before carrying out cleaning and maintenance work. Do not reconnect them until they have been completely reassembled! • Do not try to open the instrument! Risk of electric shocks! Protection against high voltage Very high voltages are generated when operating the device. High-voltage components are identified as follows:



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DANGER! Contact with high-voltage parts

General Safety Information

Severe or fatal injury! • Only operate the device if the housing is intact and closed. • Work in the area of high voltage is only allowed to be performed by personnel suitably authorised by the manufacturer. Protection against noise The noise level during administration of shock waves is within the safe area. Nevertheless, we recommend wearing suitable ear protection during treatment in order to minimise exposure to noise. Protection against explosion Do not use the Chattanooga Intelect F-SW in potentially explosive environments, i.e. in the presence of a flammable anaesthetic mixture with air or with oxygen or nitrous oxide. The optional foot switch must not be used in potentially explosive atmospheres according to classification AP as per IEC 60601.

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1.1.2

Safety during treatment of the patient General note: Organs with gas inclusions, in particular parts of the lung, are NOT allowed to be exposed to shock waves. As it passes through tissue, the shock wave’s energy is slightly reduced; this reduction is significantly weakened by the bone structure. Shock waves can give rise to undesirable heart reactions. The patient must be continuously observed during the treatment. • While applying focused shockwaves at maximum adjustment, do not use more than 6.000 subsequent shocks and stick to a consecutive break of 5 minutes. • Only perform treatments approved by the manufacturer! The user is responsible for correctly positioning the handpieces and correctly selecting the treatment zone. Air bubbles reduce the effectiveness of shock waves. Therefore, air bubbles must always be removed from the shock wave path.

1.2

Warning against damage to equipment and the device Any damage to the device resulting from incorrect operation is not covered by the manufacturer’s warranty.

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Electromagnetic compatibility This device complies with the requirements of the applicable standard on electromagnetic compatibility. Nevertheless, portable and mobile HF communications equipment (e.g. mobile phones) can interfere with medical electrical equipment.

The use of accessories or cables that are not authorised by the manufacturer can result in increased interference emissions or reduced resistance to interference emissions by the device. The Chattanooga Intelect F-SW is not allowed to be positioned immediately next to or jointly with other devices. If the operation near or jointly with other devices is required, the Chattanooga Intelect F-SW must be tested in that particular environment to ensure operation according to technical specification. If the Chattanooga Intelect F-SW is connected to a 240 V mains supply with a mains frequency of 60 Hz, the mains supply must be balanced The system must only be connected to properly earthed and correctly installed shockproof sockets!

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General Safety Information

This device is subjected to special precautions regarding EMC and needs to be installed according the EMC guidelines in chapter 9.4 Conformity with standards.

Set-up and operation • Check that the installation surfaces have sufficient carrying capacity to avoid equipment damage! There are ventilation slits on the left side of the device which must not be covered by other objects. • Check that the system is in perfect working order before each use. Read about this in Chapter 5.15 Functional checks. • Never cover the device when in use! • Make absolutely sure that no liquid can seep into the system housing or handpiece. Storage and transport Incorrect storage and transport can result in damage to the device and device failure. • Make sure that no cables are crushed or sheared. Disposal • Comply with national disposal regulations when disposing of the Chattanooga Intelect F-SW or individual components. • Comply with the relevant information in the operating manuals for the additional devices.

General Safety Information

10

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1.3

Manufacturer‘s responsibility WARNING! No modifications are to be made to this device without the permission of the manufacturer. STORZ MEDICAL AG as the manufacturer of the Chattanooga Intelect F-SW is only responsible for effects on the safety, reliability and performance of its product if: –– Maintenance of the device is performed at the intervals specified by the manufacturer –– Installation, expansions, conversions, new installations, modifications or repairs are performed by people authorised by the manufacturer –– The electrical installation in the rooms in question corresponds to the requirements of DIN/IEC –– The device is used in compliance with the operating manual The periodic maintenance measures specified by the manufacturer must be performed on schedule by authorised personnel. The manufacturer‘s liability shall be rendered null and void if non-genuine parts are used.

1.4

Owner‘s responsibility

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The owner is responsible for complying with the relevant national statutory provisions governing setting up and operating technical medical equipment. (For Germany, the Medical Products Act.)

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General Safety Information

It is expressly stated that the use of unauthorised accessories and/or unauthorised equipment combinations shall render the product liability null and void. The device is exclusively allowed to be used with accessories, wearing parts and disposable articles that have been checked by the testing body responsible for testing the device to ensure that they function without risk.

2

Principles

2.1

Physical principles The Chattanooga Intelect F-SW is a universal, compact shock wave unit that can be used for treatment involving medium- to high-energy electromagnetically generated shock waves - focused shock waves – referred to below as F-SW. F-SW waves have a short pulse length and are concentrated on areas a few millimetres in diameter, allowing pulse waves to be applied to a tightly localised area, even in deeper tissue layers.

2.1.1

Indications The Chattanooga Intelect F-SW is designed in order to treat the indications specified below: Orthopaedics / Pain Therapy –– Plantar fasciitis / heel spur / heel pain / calcaneal spur

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–– Trigger Point Therapy –– Treatment of deep muscle trigger points –– Treatment of superficial muscle trigger points –– Myofascial pain syndrome / Myofascial trigger points* / Acupuncture points –– e.g. chronic back pain (cervical and lumbar parts of vertebral column), trapezius, pelvic floor muscle trigger points –– Tendinopathy / Tendinitis / Tendonitis / Tendinosis / Tendon Pain –– Insertion tendonitis in general –– Superficial insertion tendonitis (paratendinary area) –– Shoulder pain with or without calcifications / tendinopathy of the shoulder, the supraspinatus, or / and the rotator cuff (with or without calcifications) –– (Radial/ulnar humeral) epicondylitis / tennis elbow / golfer’s elbow / elbow tendinopathy –– Greater trochanteric pain syndrome (GTPS) / Trochanteric tendonitis / Trochanteric bursitis –– Hamstring tendinopathy –– Patellar tip syndrome/ proximal iliotibial band (friction) syndrome / Patellar tendonitis / Jumper’s knee –– Tibial edge syndrome / tibial stress syndrome / tibial tendonitis –– Achillodynia / Achilles tendinitis

Principles

–– Pseudarthrosis / non-unions / delayed unions

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Dermatology –– Wound healing –– Ulceration –– Arterial ulcers –– Venous ulcers –– Diabetic foot ulcers –– Pressure sore / Decubital ulcer –– Burns –– Acute and chronic lesions –– Traumatic and post-traumatic skin lesions –– Wounds with disturbed healing –– Postsurgical wounds –– Cellulitis / lipo- / lymphedema Urology –– CPPS / prostatitis –– IPP / Peyronie’s disease –– Vascular / vasculogenic / organic erectile dysfunction Neurology –– Spastic muscle paralyses (caused by infantile cerebral palsy or stroke for example)

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Principles

* A sound knowledge of trigger point therapy and trigger point shock wave therapy (TrST) is required for therapeutic application of the Chattanooga Intelect F-SW in the field of trigger point shock wave therapy.

2.1.2

Contraindications CAUTION ! The contraindications listed here are examples. No claims are made regarding the completeness or unlimited validity of this list of contraindications.

No patient treatment is allowed under the following circumstances: –– Air-filled tissue (in particular lung tissue) in the treatment area –– Brain or spine in the treatment area –– Untreated coagulopathies (hemophilia) –– Malignant tumor in the treatment area –– Epiphyseal plate areas in children –– Pregnancy –– Use of anticoagulants, especially Marcumar –– Thrombosis in the treatment area –– Cortisone therapy up to 6 weeks before first treatment

CAUTION! 14

Shock waves must not be applied to target areas located above air filled tissue (lungs), nor to any regions near large nerves, vessels, the spinal column or head (apart from the face).

2.1.3

Side effects –– Swelling, reddening, hematoma –– Petechiae –– Pain

Principles

These side effects normally disappear after 5-10 days.

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2.2

Preconditions for operation

2.2.1

Operating personnel The Chattanooga Intelect F-SW is intended exclusively for use by healthcare professionals who have been trained to use the device. Such a specialist is expected to have practical knowledge of medical procedures and applications as well as of the terminology, and should be experienced in treating the indications stated in Chapter 2.1.1 Indications. Users must have basic physical and cognitive abilities such as vision, hearing and literacy, and have basic functional use of their upper extremities. The device is designed for a demographic target group between 18 and 65 years.

2.2.2

Training of the operator Operators of the Chattanooga Intelect F-SW must have been adequately trained in using this system safely and efficiently before they operate the device described in this handbook. An introduction to the principles of operation will be provided by your dealer with reference to this operating manual and will be documented in the system logbook. The operator must be instructed in the following points: –– Instruction in the operation and intended use of the device with practical exercises –– Mechanism of action and function of the device and the energies delivered by it –– All component settings

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–– Indications for use of the device –– Contraindications and side effects of the therapy waves –– Explanation of the warnings in all operating modes –– Instruction in how to perform the functional checks Further training requirements vary from country to country. It is the operator’s responsibility to ensure that the training meets the requirements of all applicable local laws and regulations. Further information about training in the operation of this system can be obtained from your dealer. However, you can also contact the following address directly: DJO France 3 Rue de Bethar Centre Européen de Frêt 64990 Mouguerre France

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Principles

T: +33 (0)5 57 52 86 90 F: +33 (0)5 57 52 86 91 E: [email protected]

3

System Description

3.1

Control and functional elements

2

1

3

4

1

Monitor

3

Connection for foot switch

2

Power indicator

4

F-SW handpiece connection

Fig. 3-1 Front view of Chattanooga Intelect F-SW

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System Description

9 1 2 3 4 5 6

Potential equalisation connection not used Mains connection Mains fuse holder Mains switch USB connection for USB stick, USB mouse, USB keyboard

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2

3

5

6

7 7 8 9

4

Water supply connection not used Type plate

Fig. 3-2 Rear view of Chattanooga Intelect F-SW 13 610 02 1018

NOTE The following instruments can be connected to the USB connection: –– USB memory stick which supports the USB V1.1 protocol –– USB mouse –– USB keyboard The connected instruments must be approved as medical products in accordance with EN IEC 60601.

3.2

F-SW handpiece and optional C-ACTOR handpiece Focused shock waves with a short wavelength that are concentrated on a focal zone outside the handpiece are administered over the F-SW handpiece or the C-ACTOR handpiece into the body at the treatment zone that has been established by diagnosis. NOTE Optical difference between F-SW handpiece and C-ACTOR handpiece: The F-SW handpiece has a blue ring around the coupling diaphragm and the C-ACTOR handpiece has a red ring around the coupling diaphragm.

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1 2

3

1

Trigger button

2

Clamping ring

3

Fixing screws

4

Coupling diaphragm

Fig. 3-3 F-SW handpiece or C-ACTOR handpiece The coupling diaphragm is fixed by a clamping ring and 3 fixing screws. It can only be opened from authorised personnel with special tools. The penetration depth of the shock wave can be varied by stand-off devices.

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System Description

4

3.3

Use of stand-off devices The penetration depth of the shock wave can be adjuted by using different stand-off devices.

without stand-off device

with stand-off device I

with stand-off device II

Fig. 3-4 F-SW handpiece or C-ACTOR handpiece

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Depth of focal zone

Therapeutically effective penetration depth 5 MPa 50 mm

35 - 65 mm

0 - 125 mm

0 - 105 mm

30 mm

15 - 45 mm

15 mm

0 - 90 mm

0 - 30 mm

System Description

Fig. 3-5 Depth of therapeutical effect of F-SW handpiece

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Depth of focal zone

Therapeutically effective penetration depth 5 MPa 30 mm

20 - 40 mm

0 - 65 mm

0 - 50 mm

15 mm

5 - 25 mm

0 mm

0 - 35 mm

0 - 10 mm

Fig. 3-6 Depth of therapeutical effect of C-ACTOR handpiece

• Perform changing of the stand-off devices as described in Chapter 6.2.1 Changing the stand-off device.

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19

System Description

NOTE The stand-off has a limited service life. It should be replaced if there are visible changes in the material (discolouration, tarnishing, streaks, gas bubbles), deformation of the surface in the coupling area or leaks. The stand-off should be replaced at least every 12 months.

4

Installation Instruction

4.1

Scope of supply The standard scope of supply of the Chattanooga Intelect F-SW: –– Chattanooga Intelect F-SW –– F-SW SEPIA LT handpiece –– Handpiece holder –– Mains cables –– Gel bottle –– Silicone oil bottle –– Water bag –– User manual

4.2

Unpacking • Carefully remove the instrument and accessories from the packaging container. • Check that all items are included in the packaging container and that they are not damaged.

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• Contact your supplier or the manufacturer immediately if any items are missing or damaged. • Retain the original packaging. It may prove useful for any later equipment transport.

4.3

Correct positioning of the device

Installation Instruction

Make sure that the device is positioned at a distance from the wall so that the mains plug can be pulled without restriction.

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