Instruction Manual
32 Pages
Preview
Page 1
INSTRUCTION MANUAL Ver. LT01 SW rev 1.x.x.x
The manual contains instructions for use, maintenance and handling of the device, as well as safety precautions and warnings. Read through carefully before using the device, to ensure safety and efficiency for you. Keep for future reference.
TABLE OF CONTENTS 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17.
SAFETY 4 APPLICATION SPECIFICATION 6 PACKAGE CONTENTS 7 PARTS OF THE LYMPHATOUCH 7 CONNECTORS 8 SYMBOLS AND PRODUCT MARKINGS 8 INSTALLATION 9 USING THE LYMPHATOUCH® DEVICE 12 TREATMENT SETTINGS 15 MAINTENANCE, CLEANING AND STORING THE DEVICE20 TROUBLESHOOTING 21 SERVICE 22 SOFTWARE UPGRADE 23 DISPOSAL 23 TECHNICAL DATA 25 EMC 26 TRAINING 29
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Copyright© © LymphaTouch Inc. Helsinki, Finland. All material included in this manual is intended solely for use related to the use of the LymphaTouch® device. LymphaTouch® is a trademark of LymphaTouch Inc. FDA device Class I, 510 (k) exempt, Quality 13485:2016 The information in this document is subject to change without prior notice. In a conflict situation the English version prevails.
0537 LymphaTouch Inc. Valimotie 13 A, FI-00380 Helsinki, Finland web: lymphatouch.com email: [email protected] Safety and EMC certificate LymphaTouch is CLASS 1 LASER PRODUCT INVISIBLE LASER RADIATION LymphaTouch® LT01 conforms with: Medical Device Directive 93/42/EEC RoHS Directive 2011/65/EU Copyright © 2019 LymphaTouch Oy, Made in Finland
1.
SAFETY
In this User Manual, safety precautions and warnings are indicated with the following signal words. Make sure to read and understand all safety precautions and warnings before starting to use the device. Caution – potentially hazardous situation which, if not avoided, may cause minor to moderate injuries, or damage to the device. Warning – potentially hazardous situation which can cause injuries or damage the device, if instructions are not followed. Danger – potentially hazardous situation which can result in serious injury or death, if instructions are not followed.
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1.1
SAFETY INSTRUCTIONS AND SAFETY PRECAUTIONS
USER RELATED WARNINGS AND PRECAUTIONS Warning - Do not use the device while doing maintenance. Warning - Choking resulting from child swallowing a filter. Warning - Strangulation resulting from baby or child becoming entangled by the cable • • • • • •
Never use the unit for purposes other than those recommended by LymphaTouch Inc. LymphaTouch Inc. will not be liable for any inappropriate use of the equipment. Do not leave the device in proximity of pets, pests or children. Avoid situations where the cable can be wrap around the neck. Do not use the device without having had device specific training. Be careful with negative pressure values when treating with medication (corticosteroids, anticoagulants, NSAIDS, blood thinners) in order to avoid bruising and other tissue damages. Do not pull the device from the cable between the main unit and Treatment Handle.
TREATMENT RELATED WARNINGS AND PRECAUTIONS Warning - Skin irritation due to prolonged exposure to Treatment cups. Warning - Do not treat directly over skin with open wounds. / Do not treat over open wounds or fistulas. Warning - Make sure the filter in the treatment cup is in place before attaching it to the Treatment Handle, to avoid dust and debris from being sucked into the device. Warning - Be careful when applying/treating on fragile skin and around the neck and throat area. Warning - Wipe the treatment cups carefully using a mild disinfectant or mild detergent after each use to prevent transfer of bacteria or other impurities from one patient to another. When cleaning the treatment cup, be careful not to touch the filter, as the detergent may also cause clogging of the filter. See chapter 10 for more information. • • •
Clean the device and accessories regularly following the instructions and the regulations of your institution, to ensure safe and hygienic use. Use treatment cups and treatment settings that are best suited to the anatomy and skin type you are treating. Change filters after every treatment to ensure better hygiene.
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DEVICE RELATED WARNINGS AND PRECAUTIONS Warning - Unauthorized modification of the equipment is strictly prohibited. Warning - LymphaTouch LT01 is not intended for field repair. Opening the device without authorization from LymphaTouch Inc. will void the Responsibility of the Manufacturer. Only trained service personel is allowed to change the lithium ion battery. Warning - Comply device usage, transport and storage environmental specifications Chapter 15. Device may otherwise malfunction. • • •
• • • • • •
• • • • • • •
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Don’t use the device near moist conditions for example nebuliser, steam kettle. Don’t use the device near heated surfaces for example fireplace, radiant heater. Use, store and transport the system only under the conditions described in this manual. Not following the conditions of use, storage and transport may adversely affect the performance of the system, cause electronics to malfunction or the accessories to degrade. Handle the device with care and follow the maintenance instructions. Use only accessories and mounting provided by or approved by LymphaTouch Inc. Avoid situations where the unit might fall or collide with a heavy object. Inspect the device for visible damage or malfunctions and inspect the related accessories for cracks or other signs of overuse, and replace accessories as required. Keep dry. The device contains electronic components that, if subjected to liquids, may malfunction and cause incorrect device output. Keep out of direct sunlight. Prolonged exposure to direct sunlight may cause high temperatures that damage the system. Ensure that storage conditions shown in section 15 are met. Do not use the device in the bag. When the device is taken from minimum or maximum storage temperatures, let it rest two hours in normal room temperature before usage This device needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in Chapter 16 Use original packaging when transporting the device via postal services. Store the device in its original packaging when not in use. Don’t interconnect the device with other devices. If you experience performance degradation and troubleshoot Chapter 11 doesn’t help, contact your local dealer.
2.
APPLICATION SPECIFICATION
Intended use: LymphaTouch is a negative pressure-based therapy device for health care professionals and for at-home users. It is intended to be used by persons who are knowledgeable about the treatment method and e.g. read the user manual or under supervision of those persons. The device is designed to be used as an assisting tool for manual therapy. The device helps to move excess fluid from an impaired body part to healthy regions of the body, where fluid can be absorbed and processed naturally by your body. Intended conditions of use: The environment, where this device is typically used are; physiotherapy setting including hospitals, physiotherapy centres and home use. Contraindications: ABSOLUTE • Acute deep vein thrombosis • Acute infection • Congestive heart failure • Cardiac Edema • Kidney dysfunction • Conditions in which increased venous and lymphatic return is undesirable RELATIVE • Active cancer, seek advice from home healthcare in advance • Pregnancy, seek advice from home healthcare in advance In addition, all contraindication for manual lymphatic drainage and physiotherapy apply. If you are uncertain of the suitability of the device for treatment, seek advice from healthcare professional prior to starting the treatment. As this list is not exhaustive, always seek advice from healthcare professional in the event of doubt. Intended medical indication: Improvement of lymphatic circulation in the treated area, improvement of secondary lymphedema and reduction of secondary lymphedema of the Arm (SLA) Post Mastectomy. Device is used on any one deemed to be appropriate for a physical treatment. The person using the device should be aged enough and knowledged enough to be able to understand and follow the instructions for the treatment and understand the operation of the device. Patient weight is not limited as an own indicator for LymphaTouch treatment. If you are uncertain of the suitability of the treatment consult your healthcare provider to find out the underlying issue for your weight problem before starting the treatment. Patient is the intended operator.
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Operating principle The mechanism of action is based on the effects of negative pressure in tissues. Negative pressure created by the treatment device stretches the skin and the tissue underneath, pulling on anchoring filaments to dilate the endothelial openings of lymph vessels. Vertical stretching of the fascial (connective tissue) structures is accomplished at the same time, expanding the space for circulation of blood and lymph. Lymph and the metabolic waste products that impede the healing process can then flow more easily from the interstitial space into lymph vessels, and excess fluid is carried away by the body’s own lymph transport mechanisms to re-join the venous circulation.
3. • • • • •
4. 1. 2. 3. 4. 5. 6. 7. 8.
PACKAGE CONTENTS LT-1001 Model LT01 LymphaTouch device LT-0035,LT-0050, LT-0060 and LT-0080 treatment cups LT-1601 LymphaTouch Bag LT-1315, 100pcs Filters for treatment cups Instructions for use
PARTS OF THE LYMPHATOUCH Main unit On / Off switch Touch screen Treatment Handle Different sizes of treatment cups for the Treatment Handle Soft covers for the treatment cup (detachable on 60mm treatment cup) Treatment cup filter DC-power, country adapter included. Caution: Power supply is specified as a part of the equipment.
The whole device is considered as applied part excluding the DC-power supply.
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5.
CONNECTORS
1. 2. 3. 4.
Device’s serial number Mains power USB Power ON / OFF
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2 1 Use max. 32GB USB flash drives. These should be formatted to FAT32. Warning – Do not use USB connectors while treatment is in progress. Warning – Do not connect other connectable USB devices to the port.
6.
SYMBOLS AND PRODUCT MARKINGS
In addition to the connector markers described above, you may find the following symbols and markings in the device or the package: Symbol 0537
Description The product is CE marked and the number indicates the notified body. Read the User Manual before using the device. The device is classified as Type BF Applied part, according to the standard IEC 60601. Special instructions are needed to dispose device properly. Lithium-ion battery must be disposed properly. The carton package of the device can be recycled. This side up. Manufacturer.
IP21
Enclosure is protected from touch by fingers and objects greater than 12 millimetres. Protected from dripping water. Serial number of the device. FCC declaration of conformity. Device includes BlueTooth and WLAN module.
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Symbol
Description Do not use sharp instrument to open the package Fragile. Handle with care. Humidity limitation. See more from the table page 25. Keep dry. Temperature limitation. See more from the table page 25. Atmospheric limitation. See more from the table page 25.
Rx only
A healthcare professional will provide the instructions on how to use the device. Device is tested by TÜV and fulfils NRTL.
7.
Installation
7.1 Unpacking Carefully unpack all parts of the device and confirm that all parts are included and intact. Caution - We recommend you to keep the box in case you need to return the device or send the device for service – the safest way to transport the device is to use the box it was originally shipping in. 7.2 Internal Battery LymphaTouch® has an internal battery that should be fully charged before first use. When battery is recharging, the power button light turns orange. When battery is fully charged power button light turns to green and is constant. When device is used via battery and the device is on, the light is green. 7.3 Connecting a treatment cup to the Treatment Handle Select the appropriate treatment cup for the body area in question. Please refer to the Chapter 8.5 ”Selecting a treatment cup”. Connect the treatment cup to the Treatment Handle as indicated in the figure. Caution - Make sure that the treatment cup is connected in right orientation, as indicated by the guiding rail. 11
7.4
Using filters in the treatment cup
Attach the filter to the treatment cup as indicated in the figure below. Filters are changed for every treatment for ensuring better hygiene. 7.5
Connecting removable soft part to the treatment cup
60mm treatment cups has separate soft parts. Connect the treatment cup soft part to treatment cup as indicated in the figure. 7.6
Using equipment
Place the device on a flat surface, such as a table. Make sure the cable is not pressed against anything or twisted from anywhere and it hangs relaxed from the device. User can use the device in any position. Press the treatment cup attached to the treatment handle to the skin. The device automatically starts suction when getting close to the skin. To terminate the operation quickly Press On / Off button for one second or back button when in treatment screen. It is safe to stop treatment at anytime. Lay operator and operator can use every function of the device. 7.7
Power supply with country adapters
Choose proper country adapter suitable for your mains system from the LymphaTouch package. Connecting country adapter to power supply Image 1: See that the plug and power adapter are aligned. See from the plug information which way to connect the plug to the power adapter. Image 2: Insert the plug to the power adapter. Turn clockwise and hear the click. Image 3. After connecting the plug, the final result should look like this.
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Image 2
Image 3
Disconnecting country adapter from the power supply Image1: Move the release switch in to the direction of the arrow Image2: While holding the switch, turn the adapter anti-clockwise.
Image 1 Image 2 For safety purposes do not position the device that the access AC/DC power adapter is blocked. To disconnect the device from mains, disconnect the DC-plug from the device and disconnect the power supply from the mains. 7.8
Fully assembled device
Device comes fully assembled. The only actions needed are to attach filters to treatment cups (Chapter 7.4) and to connect country adapter to the power adapter.
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8.
USING THE LYMPHATOUCH® DEVICE
8.1
Turning the device on and off
Turn the device on by pressing the on/off switch on the left side of the device. Device starts in 10 seconds. To turn off the device, press the on/off switch and hold it two seconds. The device will also shut down automatically after an 20 minutes of inactivity, while on battery power.
8.2
Screen saver
The display will shut down and the device will enter a power saving mode when the device has not been used for 10 minutes. Reactivate the unit by touching the screen.
8.3
Treatment preparation
LymphaTouch®–treatment does not require special preparation for the treatment. The treatment is applied to bare skin. Moderate application of oil or massage cream may allow the treatment cup to glide more smoothly on the skin. Avoid excessive use of oil or massage cream. If the treated skin is very dry and producing dandruff, the filter in the treatment cup may get clogged faster than normal. This will result in difficulty achieving the set pressure. Replace the filter in order to continue an efficient treatment. Do not use talcum powder or other powdery top agents on the skin.
8.4
Treatment Handle lens and sensors
LymphaTouch®–treatment handle has a lens inside. Avoid scratching the lens and keep the lens clean for the best performance. If the lens gets scratchy this may cause sensors performance to degrade.
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8.5
Selecting a treatment cup
Select the proper size treatment cup for each treatment situation. Please refer to the table below for general guidance, while using your own clinical judgment as to what is an appropriate size for each situation. Treatment cup
Size
Removable rubber ring
10 mm
Body areas • • • •
Local scars Small joints Face Head and neck
• • • •
Local scars Small joints Face Head and neck
• • • • •
Local scars Joint areas Face Head and neck Palm area
•
Whole body
• •
Torso Upper and lower limbs
LT-0010
35 mm LT-0035
50 mm LT-0050
60 mm
X
LT-0060
80 mm LT-0080
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8.6
Accessories
Code
Accessory
LT-1901
Roll Stand
LT-1020-10 LT-1004-10
Treatment cup 10mm, 20pcs Treatment cup 10mm, 4pcs
LT-1020-35 LT-1004-35
Treatment cup 35mm, 20pcs Treatment cup 35mm, 4pcs
LT-1020-50 LT-1004-50
Treatment cup 50mm, 20pcs Treatment cup 50mm, 4pcs
LT-1020-60 LT-1004-60
Treatment cup 60mm, 20pcs Treatment cup 60mm, 4pcs
LT-1020-80 LT-1004-80
Treatment cup 80mm, 20pcs Treatment cup 80mm, 4pcs
LT-1601
LymphaTouch® carrying bag
Use these codes to order accessories from the nearest distributor.
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9.
TREATMENT SETTINGS
Turn on the device. LymphaTouch® main screen will appear (see picture). The default setting is 80 mmHg with 2 s. pulsations. The unit will start operation automatically when the treatment cup is put close to the treated target.
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1. The setting is indicated on the main screen on the top left, as well as graphically in the form of a wedge. During treatment a blue wedge appears which indicates the current vacuum in the treatment cup. 2. The negative pressure is adjusted with the touch screen by moving the slider at the desired location. 3. The image on the right hand side of the screen indicates when the device has good suction. 4. During treatment, it is possible to choose either pulsating or continuous treatment. By pressing this button pulse can be set on / off. 5. To modify the pulsation setting, touch the pulse button on the main screen, and the pulsation setting screen will appear If the desired negative pressure is not achieved make sure that the treatment cup selected is suitable to the affected area of the body. If necessary replace the treatment cup with a more appropriate size, or reposition the treatment cup on the skin carefully. Also, the body hair may cause air leakage from the treatment cup. Refer to the section ”Troubleshooting.”
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9.1
Pulsation screen 4
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9.2
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Set work/rest ratio by sliding the slider at the top of the screen between 30 – 90%. Set pulse length by sliding the lower slider. Quick settings Return to previous screen Save settings and return to previous screen.
Start screen 5 1
2
4 3 1. 2. 3. 4. 5.
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Go to Settings Instructions how to use device Pre-programmed treatment programs Quick start to free mode The battery icon indicates the battery charge level. When the device is connected to the mains, battery is charging which is indicated by a flash icon.
9.3
Settings screen 1 3
2
1. Go to previous screen 2. Set screen rightness, language and use numeric keypad to input codes 3. Guidance for the software upgrade
1 2 3 4 5
1. 2. 3. 4. 5.
Go to previous screen Adjust screen rightness Adjust Treatment Handle LEDs Change language Enter numeric keypad screen.
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9.5
Numpad screen 1 2
1. Go to previous screen 2. Code is shown here 3. Numeric keypad for entering code
9.4
Vibration setting screen
1
1. Set vibration value
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3
9.6
Programs screen 1
2
1. Go to previous screen 2. Select a suitable program for you with a healthcare professional and make sure you understand the contraindications before the treatment.
1
2
1. Go to previous screen 2. Select correct program
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5
6
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1. 2. 3. 4. 5. 6. 7. 8.
Go to previous screen Dropdown list from which instructions for treated part are shown. Arrows for jumping forward or backward in treatment program Adjust pressure Adjust vibration Start treatment Adjust pulse settings Treatment area
10.
Maintenance, cleaning and storing the device
Check the device for visible damage or malfunctions regularly, and replace accessories if required.
10.1
Treatment cup maintenance and cleaning
Wipe the treatment cups carefully using for example Oxivir after each use. Disconnect the soft covers from the 60 mm treatment cup during the cleaning process. The treatment cups are not autoclavable. On the closed end of the treatment cup there is a small opening for filters. Filters prevents dust and debris from entering the device. Manufacturer recommends that treatment cups are replaced with new ones regularly or latest when there is visible wear and tear. Filters are changed for every treatment for ensuring better hygiene.
10.2
Cleaning main unit and other parts
Clean the LymphaTouch® main unit, cable and Treatment Handle by wiping them with a cloth containing mild detergent, for example Oxivir. Do not autoclave any parts of the device. 22