STORZ MEDICAL AG
D-ACTOR 200 Operating Manual Jan 2017
Operating Manual
74 Pages
Preview
Page 1
Operating Manual
D-ACTOR® 200
BS.#### Part No. 19700.01xx Published: January 2017 Original language: German
Publisher: STORZ MEDICAL AG Lohstampfestr. 8 CH-8274 Tägerwilen Switzerland 27789
Table of Contents
Table of Contents
2
1
General Safety Information
6
1.1
Instructions for safe use
6
1.1.1
Designated use and operational safety... 6
1.1.2
Safety during treatment of the patient... 7
1.2 Warning against damage to equipment and the device
7
2
Principles
9
2.1
Physical principles
9
2.1.1
Indications... 9
2.1.2
Contraindications
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2.1.3
Side effects .
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10
2.2
Preconditions for operation
2.2.1
Operating personnel... 10
2.2.2
Training of the operator
3
System Description
12
3.1
Control and functional elements
12
3.2
Scope of supply
13
3.3
Unpacking
13
3.4
Transport
14
3.5
Installation Instructions
14
3.5.1
Mounting the handpiece holders .
3.5.1.1
Handpiece holder
3.5.1.2
Suction cup holder... 15
3.5.2
Connecting the electrical power supply
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3.5.3
Connecting the potential equalisation
... 16
3.5.4
Connecting handpiece... 16
3.5.5
Connecting Tablet (optional)... 16
3.5.6
Connecting VACU-ACTOR .
3.5.7
Connecting the foot switch
3.6
Compatibility
18
3.7
Symbols
19
4
Operation
20
4.1
Switching on and off
20
4.2
Operation
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4.3
Operation of the handpiece
21
4.4
Operation of the Touch Screen of the Tablet PC
22
4.4.1
Module selection... 23
4.4.2
Parameter selection and counter display... 24
4.4.3
Contact intensity and Skin Touch display
4.4.4
Treatment menu bar... 28
4.4.5
Device info and settings menu bar .
4.5
Touch screen operation
4.5.1
Configuration and reset... 30
4.5.2
Password protection... 31
4.5.3
Setting brightness and volume... 33
4.5.4
Selecting the operating mode .
4.5.5
Selecting treatment parameters... 34
4.5.6
Loading indications... 34
4.5.7
Saving indications .
4.5.8
Copying indications .
4.5.9
Deleting an indication... 40
4.5.10
Editing indications
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4.5.10.1 Storing treatment notes... 41 4.5.10.2 Loading images and/or videos .
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4.5.10.3 Creating, deleting or editing treatment steps... 42 4.5.11
Patient treatment report .
4.5.11.1 Loading patient data
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4.5.11.2 Editing patient data .
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4.5.11.3 Load treatment parameters
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Software updates
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4.5.16
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Resetting the treatment pulse counter... 47 .
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Deleting patient datasets... 47 .
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Exporting treatment data... 47
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Creating new patient data .
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4.5.16.1 Software Update Tablet PC... 48 4.5.16.2 Software Update D-ACTOR®200... 48 4.5.17
Changing software settings .
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4.5.18
Visible Body - Anatomy Atlas... 49
4.5.18.1 Starting Visible Body... 50 4.5.18.3 Exiting Visible Body... 52 4.6
Setting treatment parameters
52
4.7
Start-up
53
4.8
Functional checks
53
4.9
Standard settings
54
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Table of Contents
4.5.18.2 Marking treatment regions... 51
Table of Contents
4
4.10
Treatment with D-ACTOR or V-ACTOR handpiece
4.10.1
Setting parameters... 56
4.10.2
Coupling the handpiece
4.10.3
Triggering pulses... 56
4.10.4
Functions overview of the handpiece D-ACTOR
4.11
Treatment with VACU-ACTOR
4.11.1
Using the foot switch
4.11.2
Using the Tablet PC (optional)... 58
5
Cleaning, Maintenance, Overhaul
59
5.1
Cleaning
59
5.1.1
Cleaning the tablet... 59
5.1.2
Cleaning the handpieces
5.1.3
Reconditioning the VACU-ACTOR
5.1.3.1
Preparation of cleaning .
5.1.3.2
Cleaning... 61
5.1.3.3
Disinfection
5.1.4
Fuse replacement
5.2
Maintenance and safety checks
62
5.3
Disposal
63
5.4
Repair
63
5.5
Service life
63
6
Accessories
64
7
Technical Specifications
65
7.1
Technical Specifications
65
7.2
Type plate D-ACTOR®200
66
7.3
Conformity with directives
66
7.4
Conformity with standards
67
7.4.1
EMC guidelines and manufacturer’s declaration .
7.5
Certificates
71
7.6
Symbols and labels
72
8
Warranty and Service
73
8.1
Warranty for the control device
73
8.2
Warranty for the handpiece
73
8.3
Warranty for the VACU-ACTOR
73
8.4
Service
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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.
5 CAUTION indicates that incorrect operation could lead to minor injuries. 
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'. 19 620 02 0117
Preface
NOTE
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 D-ACTOR® 200.
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 D-ACTOR® 200. • Read the separate operating manuals for all devices associated with the D-ACTOR® 200.
1.1.1
Designated use and operational safety In order for the user to use this device in accordance with its designated use, the user must possess the necessary technical proficiency, and knowledge of the operating manual. The device is only allowed to be used for the applications described in Chapter 2.1.1 Indications. • Only perform treatments approved by STORZ MEDICAL AG!
6
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.
General Safety Information
• It is essential to perform the functional checks after switching on the D-ACTOR® 200 before starting treatment. Read about this in Chapter 4.8 Functional checks. • Have the maintenance procedures recommended by the manufacturer carried out by authorised personnel (see also Chapter 5.2 Maintenance and safety checks). 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 D-ACTOR® 200 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.
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• Disconnect the D-ACTOR® 200 from the mains before starting any cleaning or maintenance work! • Disconnect the connected handpieces from the device before carrying out cleaning and maintenance work. Do not reconnect them until they have been completely reassembled! • The optional KARL STORZ foot switch must not be used in potentially explosive atmospheres according to classification AP as per IEC 60601. Protection against noise The noise level during administration of pulses is within the safe area. Nevertheless, we recommend wearing suitable ear protection during treatment in order to minimise exposure to noise.
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 pulses. As it passes through tissue, the pulse energy is slightly reduced; this reduction is significantly weakened by the bone structure. Pulses can give rise to undesirable heart reactions. The patient must be continuously observed during the treatment. Only perform treatments approved by STORZ MEDICAL AG! The user is responsible for correctly positioning the handpieces and correctly selecting the treatment zone.
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No more than 6,000 pulses are allowed to be administered without interruption. Treatment with the suction cup must be limited to 30 minutes.
arning against damage to equipment and W the device Any damage to the device resulting from incorrect operation is not covered by the manufacturer’s warranty. 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. This device is subjected to special precautions regarding EMC and needs to be installed according the EMC guidelines in chapter 7.4.1 EMC guidelines and manufacturer’s declaration.
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General Safety Information
1.2
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 D-ACTOR® 200 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 D-ACTOR® 200 must be tested in that particular environment to ensure operation according to technical specification. The system must only be connected to properly earthed and correctly installed shockproof sockets! Set-up and operation 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 4.8 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.
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Disposal • Comply with national disposal regulations when disposing of the D-ACTOR® 200 or individual components.
General Safety Information
• Comply with the relevant information in the operating manuals for the additional devices.
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2
Principles
2.1
Physical principles The D-ACTOR® 200 is a compressed air–operated ballistic pulse generator. The pulses in the D-ACTOR® 200 are generated with a precision ballistic mechanism in the handpiece. A projectile is accelerated by compressed air. The motion and weight of the projectile produce kinetic energy. When the projectile impacts against an immovable surface, the transmitter, this kinetic energy is converted into sound energy. This acoustic pulse is transmitted into the tissue to be treated either directly or via an acoustic impedance adapter with the help of a gel. The D-ACTOR®200 in combination with VACU-ACTOR is a supplement to the treatment with D-ACTOR and V-ACTOR. Thereby tissue will be treated by means of a suction cup in pulsating vibrations. Either it will be changed between vacuum (feel stretching of the tissue) and pressure (expansion pressure) or between vacuum (feel stretching of the tissue) and a short vent (athmospheric pressure). This function is realized by a high-performance compressor.
2.1.1
Indications The D-ACTOR 200 is designed for pulse activation treatment (PAT) intended to relieve minor muscle aches and pains.
2.1.2
Contraindications 9
CAUTION! No claims are made regarding the completeness or unlimited validity of this list of contraindications. Treatment with the STORZ MEDICAL D-ACTOR®200 is not permitted in the following cases: –– Coagulation disorders (haemophilia) –– Use of anticoagulants, especially Marcumar –– Thrombosis –– Pregnancy –– Cortisone therapy up to 6 weeks before first treatment
CAUTION!
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Principles
Pulses 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 Treatment with the D-ACTOR® 200 may cause the following side effects: –– Swelling, reddening, haematomas –– Petechiae –– Pain –– Skin lesions after previous cortisone therapy These side effects generally abate after 5 to 10 days.
2.2
Preconditions for operation
2.2.1
Operating personnel The D-ACTOR® 200 is intended exclusively for use by health care professional and may only be used by suitably qualified and trained medical personnel. 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 10
Training of the operator Operators of the D-ACTOR® 200 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 STORZ MEDICAL 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 designated use of the device with practical exercises –– Mechanism of action and function of the device and the energies delivered by it –– All component settings –– Indications for use of the device –– Contraindications and side effects of the therapy waves –– Explanation of the warnings in all operating modes
Principles
–– Instruction in how to perform the functional checks
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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 STORZ MEDICAL dealer. However, you can also contact the following address directly: STORZ MEDICAL AG Lohstampfestrasse 8 Postfach CH-8274 Tägerwilen Switzerland
Telephone: +41 (0) 71 677 45 45 Fax: +41 (0) 71 677 45 05
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Principles
11
3
System Description
3.1
Control and functional elements The D-ACTOR® 200 is exclusively controlled using the operating and display elements on the handpiece.
1
1
Handpiece connector V-ACTOR
2
Handpiece connector D-ACTOR
3
Handpiece connector D-ACTOR
4
Connector VACU-ACTOR
2 4
3
Fig. 3-1 Front and right side of D-ACTOR®200 1 2
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6 5
1 2 3
3 4 5 6
4
A/B Switch Mains connector with mains switch USB-B 1.1 Device interface Potential equalisation Footswitch connector USB-A 1.1 Host interface
Fig. 3-2 Rear side D-ACTOR®200
NOTE The USB-B1.1 connection (Fig. 3-2/3) is generally used for service purposes. In addition it is possible to connect a Tablet PC.
System Description
The USB-A1.1 connection (Fig. 3-2/5) is only used for connecting a USB memory stick for software update which supports the USB V1.1 protocol or higher.
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1
1 2
Opening for the nebulizer Openings for handpiece holder
2
Fig. 3-3 Bottom side D-ACTOR®200
3.2
Scope of supply The standard scope of supply of the D-ACTOR® 200 includes the following items: –– D-ACTOR® 200 control device –– Mains cable (EU / USA) –– Gel bottle –– User manual (operating manual, systembook and training records) –– D-ACTOR handpiece set –– Handpiece holder, complete
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–– VACU-ACTOR start kit (4 suction cups different sizes, depositing shelf, holder for the suction cup, transport case)
3.3
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.
• Retain the original packaging. It may prove useful for any later equipment transport.
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System Description
• Contact your supplier or the manufacturer immediately if any items are missing or damaged.
3.4
Transport It requires two persons to transport the device after unpacking riskless and safe to the treatment place. NOTE Make sure that your hands are dry and free of grease. • Dismount the handpiece holder before transporting the device. • Grip on the front and on the rear side with both hands on the bottom of the device as shown in in Fig. 3-4 and lift it carefully.
Fig. 3-4 Transporting the device • Set the device slantly down in order to avoid squeezing the fingers.
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3.5
Installation Instructions
3.5.1
Mounting the handpiece holders There are openings for 6 handpiece holders and /or suction cup holder - 3 on the right side and 3 on the left side of the D-ACTOR 200 in each case in the front, in the middle and rear section.
3.5.1.1
Handpiece holder There are two different handpiece holder: –– for handpieces D-ACTOR
System Description
–– for handpieces V-ACTOR.
1
Openings for insertion of the handpiece and suction cup holder
1 Fig. 3-5 Mounting the handpiece holder 19 620 02 0117
The mounting of the handpiece holder is equal for both types. • Push the holder into the provided openings at the D-ACTOR®200.
3.5.1.2
Suction cup holder
1
Openings for insertion of the handpiece and suction cup holder
1 Fig. 3-6 Mounting the suction cup holder • Push the holder into the provided openings at the D-ACTOR®200.
3.5.2
Connecting the electrical power supply • Connect the supplied mains cable to the mains connector on the rear side of the device.
15 1 2
1
Mains connector Connector for potential equalisation
2
Fig. 3-7 Connecting the electrical power supply • Insert the mains cable into the socket. ATTENTION !
The instrument must only be connected to properly earthed and correctly installed shockproof sockets! The device must be positioned in a way so that disconnection from the mains is easy to do.
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System Description
When setting up the instrument, make sure that the air outlets on the housing of the D-ACTOR® 200 are not blocked.
3.5.3
Connecting the potential equalisation At the rear side of the device a connection of a potential equalisation (Fig. 3-7/2) is available if due to national regulations or room class a connection is required. • Connect the cable for the potential equalisation to the PE connector of the D-ACTOR 200 (Fig. 3-7/2) and connect it to your PE connector.
3.5.4
Connecting handpiece • Insert the plug of the handpiece into the corresponding handpiece connector on the left rear side of the device. 1
Handpiece connector V-ACTOR
2 and 3 Handpiece connector D-ACTOR 4
1
Connector VACU-ACTOR
2 3 4 Fig. 3-8 Connectors of the Handpieces and VACU-ACTOR • Make sure that the red dot on the socket is aligned with the red dot on the handpiece connector.
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• Place the handpiece into the handpiece holder. NOTE Please also refer to the separate operating manual for your handpiece.
3.5.5
Connecting Tablet (optional) 1 2
USB connector to D-ACTOR 200 Main switch of the Tablet
1
System Description
2
Fig. 3-9 Tablet with charching device and USB cable
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1 2
USB connector for connecting Tablet PC Footswitch connector
2 1
Fig. 3-10 Connection of tablet and footswitch - D-ACTOR 200 rear side • Connect the USB connector of the tablet into the USB connector on the rear side of the D-ACTOR 200.
3.5.6
Connecting VACU-ACTOR 2
1 2 3
3
1
4 5
4
Coupling silicone hose Hose Coupling for connection the suction cup Suction cup Bacteria filter
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5
Grössenverhälnisse sind nicht real
Fig. 3-11 Connection VACU-ACTOR
NOTE
• Insert the transparent suction cup into the coupling at the end of the longer hose part. –– There are suction cups in 4 different sizes to choose from. • Insert the coupling of the shorter hose part into the connection clutch on the right side of the D-ACTOR 200 (Fig. 3-8 / 4).
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System Description
Immediately after the device output a one-sterile filter is used to avoid contamination of the device and to protect the following patients against comtamination.
NOTE The silicone air hose including the bacteria filter is a disposable part. It must be disposed after each treatment to protect the patient and the system against cross-contamination.
Fig. 3-12 available suction cups
3.5.7
Connecting the foot switch The connector for an optional foot switch (article no. 10103) is located on the rear side of the D-ACTOR 200 (Fig. 3-10). • Plug the plug of the foot switch into the connector on the rear side of the D-ACTOR 200. Treatment with the VACU-ACTOR can be activated and deactivated with the aid of the foot switch.
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Fig. 3-13 Optional Karl Storz foot switch
System Description
3.6
Compatibility The STORZ MEDICAL D-ACTOR 200 is allowed to be operated with the following handpieces: –– handpiece D-ACTOR
part.no. 21700.xxxx
–– handpiece D-ACTOR LT
part.no. 23213.xxxx
–– handpiece V-ACTOR
part.no. 19365.0001
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3.7
Symbols You must read the operating manual Application unit of type B Potential equalisation Connector D-ACTOR handpiece Connector V-ACTOR handpiece Connector VACU-ACTOR USB-connector CE mark (in accordance with the Medical Device Directive (MDD) 93/42/EEC) CSA test mark WEEE label
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19
System Description
wearing ear protection
4
Operation
4.1
Switching on and off • Switch on the device using the main switch on the rear side of the device.
1
main switch
1
Fig. 4-1 Main switch
4.2
Operation The following options for operating the D-ACTOR 200 are available: –– D-ACTOR 200 with D-ACTOR handpiece –– via the display of the handpiece –– via the tablet touch screen
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–– D-ACTOR 200 with V-ACTOR handpiece –– via the tablet touch screen
Operation
–– D-ACTOR 200 with VACU-ACTOR –– via the foot switch –– via the tablet touch screen
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