Tens 1000 s - Massage device Promed - Free user manual and instructions

USER MANUAL Tens 1000 s Promed

Voll's Investors Inc.

1月，No.16.1204

Largers Bond Funds Class

New Taipei City,

2041.13

图4-1

169501

Via Fucil 7,20121

Name:

(3) 2017年1月1日

ROHS COMPLIANT CE 0126

promed

MGA-2019, 1130 (8/17)

Transcanning District New Service (NCN)

Special of Electrochemical Structure (TNS)

Approachos per lekmotrolarone rencon par va hortacama [TPN]

Product catalog image showing medical devices, battery pack, and accessories with labeled parts

Labeled diagram of a handheld device with numbered parts and internal components shown in views

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Promed GmbH Komatische Dresignisse Underweg 11, B 82490 Forchort, Cemare Tel. [phone], Fax [phone]

Über dieses Gerät:

Modulation: O B O N O M

Line drawings of a human body in front and back views, showing no text or symbols

Line drawings of a human figure in four sequential views, showing standing and back angles (no text or symbols)

INFORMATIONEN ZU BATTERIE- UND AKKUBETRIEB

promed Promed GmbH, D-82490 Farchant, Germany Tens 1000 s Well-Life Healthcare Inc. 1 Fl., No.16, Lane 454, Jungjeng Road, Yunghe District New Taipei City, 23455, Taiwan SN 2012-08 CE 0120

Please keep the instructions in a safe place!

Please read the user manual thoroughly before using the device for the first time.

Thank you for purchasing the Promed tens 1000 s. You have purchased a high-quality product designed for personal hygiene and wellbeing purposes. Promed is a leading company with decades of experience in personal hygiene, wellness and health areas.

The TENS unit has been designed and manufactured in accordance with the Medical Device Directives 93/42/EEC to guarantee quality during use. The device may be used once this user manual has been read.

We, as the manufacturer, cannot be made liable in any way for injury or damages to people or objects that arise from failure to comply with this user manual. We wish you a lot of enjoyment with your new Promed tens 1000 s. We would like to familiarize

you with the TENS unit in the following sections. Please read the user manual thoroughly before using the device for the first time. You can receive professional advice wherever Promed products are sold or get in touch with us if you have any questions. We can provide you with the name of the representative responsible for you.

Further informations can be found on our homepage: www.promed.de

DESCRIPTION OF THE UNIT

About this unit:

Your tens 1000 s is a battery-powered device with two adjustable output channels. The TENS unit generates electrical impulses. You can use the unit's controls to set and vary the amplitude, duration and modulation of these impulses. The TENS unit's controls are very straightforward to use, while the safety cover stops your settings being modified unintentionally.

1 Sockets for the electrode leads (left and right channel)
2 Intensity regulators (left and right channel)
3 Status LEDs
4 Pulse width regulator
5 Mode selector
6 Pulse frequency regulator
7 Timer

8 Battery
9 Battery compartment
10 Battery strap
11 Cover
12 Electrode plugs
13 Lead plug (the same for both channels)

PACKAGE CONTENTS

System components

Your tens 1000 s - package contains the following equipment:

1 Unit
2 Carrying case
3 Leads
4 Cloth electrodes, 40 x 40 mm
5 Operating instructions
6 Instructions for cloth electrodes
7 9 Volt battery

Not included in the package / available separately:

8 Rechargeable battery
9 Battery charger

INTRODUCTION

What is pain?

Pain is the body's own early warning system. Feeling pain is important, as it indicates an abnormal condition within the body and serves as a warning to us before any further damage or injury occurs. However, long-term, persistent pains – often known as chronic pain – serve no obvious useful purpose once a diagnosis has been made. TENS was developed to soothe or eliminate certain types of chronic and acute pain.

How does TENS work?

TENS is a non-invasive and drug-free method of treating pain. The TENS unit transmits soothing electrical pulses through the skin that stimulate the nerve (or nerves) in the area being treated. In most cases, this stimulation greatly reduces or even completely eliminates the sensation of pain, as it blocks the original pain signals to the brain.

It is also reported that TENS stimulation promotes the release of endorphins into the bloodstream, leading to a further reduction in pain.

The benefits of TENS devices in pain management have been clinically proven in the case of many patients. To get the most out of your TENS unit, read these instructions carefully and follow your doctor's recommendations for treatment.

INDICATIONS / CONTRAINDICATIONS

Please read these instructions before using the TENS unit.

In the USA, the sale of this device is restricted by law to doctors, or subject to a doctor's prescription.

Indications

Transcutaneous Electrical Nerve Stimulation (TENS) can be prescribed by doctors for the symptomatic reduction and treatment of chronic (long-term) pain and to treat postoperative or post-traumatic pains.

Contraindications

Be sure to consult a doctor before using the unit!

• Patients with implanted electronic devices (e.g. a pacemaker) or metal implants should only undertake TENS treatment after consulting a doctor.
• Any positioning of the electrodes that transmits electrical impulses to the carotid sinus nerve (neck).
• Any positioning of the electrodes that transmits electrical impulses transcerebrally (through the head).
• The use of TENS before symptoms of pain have been diagnosed and the cause has been determined.

WARNINGS / PRECAUTIONARY MEASURES

Warnings

• TENS devices must be kept out of the reach of children.
- The safety of using TENS devices during pregnancy or delivery has not been proven.
- TENS is not effective in treating pain of the central nervous system (headaches).
- Should TENS treatment fail to work or cause discomfort, stimulation should be discontinued until a doctor has reassessed the situation.
- Do not attempt to adjust the settings of the unit while driving a vehicle or operating machinery.
- Always switch the TENS unit off before attaching or removing the electrodes.
- TENS can interfere with electronic monitoring equipment (ECG monitors/alarms).

• Never position the electrodes over the eyes, in the mouth or within the body.
  • TENS devices do not possess any healing properties.
• TENS is a method for treating symptoms and as such only suppresses the perception of pains that would otherwise serve as a defence and warning mechanism for the body.

Precautionary measures / Negative reactions

• Long-term use can occasionally lead to skin irritation in the area where the electrodes were placed.
• The effectiveness of the treatment depends greatly upon the patient being treated by someone who is qualified in dealing with patients suffering from pain.
• Potential negative reactions include skin irritation and burns caused by the electrodes.

OPERATING THE UNIT

Safety cover: The controls for pulse width, pulse frequency, mode selection and modulation selection are protected by a safety cover. To open cover 11, grip the upper end by the sides and lift open the cover.

Intensity: The intensity regulators 2 are to be found on the upper side of the unit and are used to set the intensity of stimulation. They are also used to switch the unit on and off.

Mode: The mode selector 5 is used to set the type of treatment. The three available modes are: burst stimulation [Burst] (B), continuous stimulation [Continuous] (C) and modulated stimulation [Modulated] (M).

Pulse width ( s): The control knob 4 regulates the pulse width (= the duration of individual impulses) for both channels.

Pulse frequency (Hz): The pulse frequency knob 6 regulates the number of pulses per second for both channels.

Timer: With the aid of the timer control 7, you can set the duration

of TENS treatment. There are three possible settings: 15, 30 minutes and C (continuous). Use the switch to select the desired setting.

Resetting the timer: To restart treatment or reset the timer, simply switch the intensity regulator 2 into the OFF position, then back to the ON position.

Mode functions: Burst mode (B) triggers two individual bursts per second. In this mode, the pulse frequency is set at 100Hz per second, while the pulse width is adjustable. In continuous stimulation mode (C), impulses are transmitted continuously at the selected settings for intensity, pulse frequency and pulse width. In modulation mode (M), the pulse width set by the user is reduced by 60%. This lower pulse width is maintained for 2 seconds before returning to the original user setting, which is then maintained for 3.5 seconds. The cycle is then repeated. Intensity and pulse frequency are adjustable by the user.

CONNECTING THE ELECTRODE LEADS

The leads supplied with the TENS unit are to be connected to the sockets on the upper side of the unit 1. Hold the plug by the insulated part and push the end of the plug into one of the sockets. You may use one or two sets of leads. After you have connected the leads to the stimulator unit, connect an electrode to each lead 2. The leads supplied with the TENS unit conform to the FDA Compliance Standards.

Please note:

Take care when connecting and removing leads. If you pull on the lead rather than holding the insulated part of the connector, the lead may be damaged.

Caution:

Never plug the lead into an AC (alternating current) outlet.

Sockets for the electrode leads left channel and right channel 1 Lead plugs (the same for both channels) 2 Electrode plugs

SELECTION, CARE AND USE OF ELECTRODES

Your doctor should decide which type of electrode is best suited to your treatment. To achieve optimum stimulation results and avoid skin irritation, follow the procedures described in the instructions supplied with the electrodes. The electrode package will include tips and information on care and maintenance and the correct storage of your electrodes.

Using electrodes

Please make sure that the tens 1000 s is switched off when connecting or removing electrodes.

Positioning the electrodes

Please refer to the operating instructions for the tens 1000 s electrodes included with the package. To ensure that TENS therapy remains effective for a long time, you should replace the TENS electrodes regularly. The skin to be treated should be clean and free of grease.

Handling electrodes

After use, the electrodes must be put back on the protective foil to ensure that they continue to function effectively. If the adhesive properties of the electrode start to deteriorate after being used many times, you may use a contact gel, which you can remove with a cloth after use. It is necessary to replace the electrodes after a maximum of 30 uses.

For hygienic reasons, each patient should use their own set of electrodes.

CONNECTING THE TENS UNIT

1. Preparing the skin

Prepare the skin as described above and in the instructions that came with the electrodes. Position the electrodes in the area recommended by your doctor.

2. Connecting the leads to the electrodes

Connect the leads to the electrodes before attaching the electrodes to the skin.

Caution: Make sure that the intensity regulators 2 for both channels 1 and 2 are in the "OFF" position.

3. Attaching the electrodes to the skin

Attach the electrodes to your skin in the manner recommended by your doctor.

4. Connecting the leads to the TENS unit

Plug the lead into the appropriate channel socket, pushing the plug as far as possible into the socket (see "Connecting the electrode leads").

5. Selecting the settings for treatment

Make sure that the settings selected on the unit are those recommended by your doctor.

6. Setting channel intensity

The intensity regulator 2 is to be found on the upper side of the unit. Turn the control knob for channel 1 or 2 in a clockwise direction. The power LED will light up when the unit is switched on. Slowly turn the control knob in a clockwise direction until you reach the intensity setting recommended by your doctor. If both channels are being used, repeat the same procedure for the other channel.

Effective skin care is especially important in order to ensure comfortable use of your tens 1000 s unit.

• Always wash the areas of skin where the electrodes are to be placed using mild soap and water. Thoroughly wash off any soap remains and carefully dry the skin before using an electrode.
• To ensure effective contact between the skin and the electrode, excess hair should be cut but not shaved off prior to treatment.

• You may prepare the skin with a skin care product recommended by your doctor. After applying it, let it dry before attaching the electrodes as described. This will reduce the likelihood of skin irritation and prolong the life of your electrodes.

• Avoid excessive pulling of the skin when attaching the electrodes. The best way to achieve this is to place the electrode on the skin and carefully smooth it out from the centre outwards.

• When removing the electrodes, always pull them off in the direction of hair growth.
• It may be helpful to apply a skin cream to the area being treated while the electrodes are not being worn.

CARE AND MAINTENANCE

• Switch the unit off when it is not in use.
• Before putting the tens 1000 s into storage for a longer period of time, remove the batteries from the compartment. Keep the unit and its accessories in a cool, dry place in the case provided.

• You can clean your tens 1000 s by wiping it over carefully with a cloth moistened with mild soapy water. Never immerse the unit in water or other liquids. You may also use isopropyl alcohol or a soap solution. Household detergents and cleaning products are not suitable.

• Handle the electrodes by their edges when removing them. To avoid damaging them, never pull at the electrode leads themselves.

• If the electrode leads get dirty, wipe them off with a damp cloth as described above.
• The unit must be returned to your dealer or the manufacturer every two years for inspection and recalibration.

POSITIONING ELECTRODES

Hand-shoulder syndrome Lumbar vertebrae syndrome Joint pains Joint pains Hand-shoulder syndrome "Tennis elbow" and joint pains DE US FR IT ES

POSITIONING ELECTRODES

APPLICATION EXAMPLES

Mode Intensity (mA) (μSec)	Pulse width (μSec)	Pulse rate Frequency (Hz)	Cycle time (Sec)	Possible areas of use
Continuous	adjustable	adjustable	not available		To ease muscle parts and to stimulate circulation. To ease stabbing and intense pain as well as dull and throbbing pain. To warm, loosen up and relax the limbs (legs, arms) and the back. For use with urge incontinence. To combat headaches. Acts to improve concentration. Counteracts you from getting used to the stimulus. To ease pain and tension. To combat pain in the neck and shoulders and symptoms in the knees.
	0-80 mA	30-260 μSec	2-150 Hz
Burst	adjustable	adjustable	100 Hz fixed not available		To ease muscle parts and to stimulate circulation. To ease stabbing and intense pain as well as dull and throbbing pain. To warm, loosen up and relax the limbs (legs, arms) and the back. For use with urge incontinence. To combat headaches. Acts to improve concentration. Counteracts you from getting used to the stimulus. To ease pain and tension. To combat pain in the neck and shoulders.
	0-80 mA	30-260 μSec	2 bursts per sec.
Modulation	adjustable	modulated	adjustable	5,5 Sec	To ease muscle parts and to stimulate circulation. To ease stabbing and intense pain as well as dull and throbbing pain. To warm, loosen up and relax the limbs (legs, arms) and the back. For use with urge incontinence. To combat headaches. Acts to improve concentration. Counteracts you from getting used to the stimulus. To ease pain and tension. To combat pain in the neck and shoulders and symptoms in the knees.
	0-80 mA down	by 60% compared to the original set pulse width level, then returns to original level	2-150 Hz Total time

CLINICAL RECOMMENDATIONS

Clinical recommendations for setting up the tens 1000 s

Settings: ....

Pulse frequency (Hz): ....

Pulse width ( s): ....

Modulation: O B O N O M

Duration of treatment: ...... minutes

Number of sessions per day: ____

Intensity: ....

To be filled out by your doctor!

Line drawings of a human body in front and back views, showing anatomical differences (no text or labels)

CLINICAL RECOMMENDATIONS

Positioning the electrodes To be filled out by your doctor!

Line drawings of a human figure in four different views, showing standing and back angles (no text or symbols)

INFORMATION ON BATTERY AND RECHARGEABLE BATTERY USE

Changing the battery / rechargeable battery

1. Remove the used battery from the unit.
2. Insert a new battery into the compartment. Make sure that the polarity of the battery matches that shown in the compartment.

The unit is designed to be used with a 9 Volt battery. It is also possible to use a rechargeable battery. Please remember that alkaline batteries have a higher capacity and longer life than the rechargeable equivalents. You must never use damaged batteries.

A rechargeable battery must be charged before the first use. To ensure a long life, the battery should always be stored in a fully charged state. A rechargeable battery should not be allowed to run down too far, as this can cause damage to the battery.

When charging, follow the instructions supplied by the battery or charger manufacturer. (Rechargeable batteries and charger are available separately in specialist stores.)

DISPOSAL

Power tools, accessories, and packaging should be recycled in an environmentally suitable manner.

Only for EU countries:

Do not dispose of power tools with the domestic waste! In accordance with the European Directive No. 2002/96/EEC on waste electrical and electronic equipment and its implementation into national law, nonfunctioning power tools must be collected separately and recycled in an environmentally suitable manner.

Rechargeable batteries/batteries:

According to the Directive 91/157/EEC, defect or used rechargeable batteries/batteries must be recycled. Waste rechargeable batteries/batteries can be directly handed to:

Promed GmbH, Lindenweg 11, D-82490 Farchant.

SAFETY INSTRUCTIONS

Pay attention to the following before first time operation:

• Only for home use.
• Scrupulous supervision is required when the device is being used in the vicinity of children.
• Never place or use the unit in a wet or moist environment.
  • Do not use the unit under water, e.g., under the shower.
• Never place the unit in direct contact with fire, gas or oxygen, or hot objects such as hot plates.
  • Take every precaution possible to ensure that the unit does not fall down or get damaged in any other way.
• If problems do arise with the unit, take it immediately to get it repaired.
• Do not lubricate or wash the unit.

Danger!

• Do not place the unit in direct contact with water or other fluids.
• It is not permitted to use the unit outdoors.
• Never touch the unit with wet hands.
• Do not store the unit near a wash basin or bath tub as there is the danger that the unit may fall or be pulled into the wash basin or the bath tub.

Warning!

• Never leave the unit unattended when children or inexperienced persons are in the vicinity of the unit.
  • Make sure that children do not play with the device.
• Only use the unit for the applications described in this manual.
• This unit is not designed for use by people (including children) who have limited physical, sensory, or intellectual abilities or

SAFETY INSTRUCTIONS

who do not have sufficient experience and/or sufficient knowledge. This does not apply if these people are supervised by a person responsible for their safety or receive instructions from them on how to use the unit.

• Do not use the unit underneath blankets or cushions as excessive heat may cause fire, injury or an electrical shock.
• Do not carry the unit by its cable and do not use the cable as a handle.

• It is not permitted to use the unit outdoors.

• When you have finished treatment, place the intensity controllers 2 in the "OFF" position.

• Never let children play with the packaging material; there is a risk of suffocation.

TROUBLESHOOTING

SERVICE AND MAINTENANCE

If your TENS unit is not functioning correctly

1. Make sure that the battery is correctly inserted or replace the battery. When inserting a battery, make sure that the polarity is correct.
2. If the ON/OFF LED is flashing and there is no stimulation, check that the leads are attached correctly and that the electrodes are correctly positioned. If the unit seems to be functioning, yet you still feel no stimulation, it is possible that the electrodes or the leads need replacing.
3. If the battery is charged but the unit is not working, turn both intensity controls 2 to the OFF position (counterclockwise) and then slowly back to the ON position.

Service and maintenance

If you should experience other problems, consult your dealer, returning the unit if necessary. Never attempt to repair a fault yourself.
For repair or maintenance, send the tens 1000 s via your dealer to:

This unit has been manufactured with the utmost of care and has been examined in detail before leaving the factory. We therefore provide a warranty of 24 months after the date of purchase when presented with the warranty card issued with this appliance and in accordance with the following conditions:

• Within the warranty period, we will replace all defect parts of the unit free of charge, including labor costs for repairs under warranty, in cases of verifiable faults in material or manufacture that have occurred with correct usage and have been identified during the warranty period.
• This warranty is void when the unit has been improperly used (e.g., connection to unsuitable sources of electricity, breakage), the unit has been tampered with (e.g., opening the units casing), and when spare parts have been used that have not been approved of by Promed. Parts subject to wear are exempt

from the warranty. Appliance motors and mobile parts are not included in the warranty.

• The warranty period begins on the date of purchase. Warranty claims do not affect the warranty duration. Warranty claims must be lodged within the warranty period. Claims arising after cessation of the warranty period cannot be considered.
• The warranty only comes into effect within the scope of these warranty conditions when the date of purchase has been confirmed by the stamp/ signature of the dealer on the warranty card.
• In cases of warranty or repair claims, please post the entire unit with the completed warranty card to the customer service point responsible for you.
• We reserve the right to make technical and optical changes as well as changes to the equipment!

TRANSPORT/STORAGE/OPERATING CONDITIONS

SPECIFICATIONS

Only transport in the original packaging.

Transport and storage temperature: +5°C - +50°C (+41°F to +122°F)

Operating temperature: +10°C - +40°C (+50°F to +104°F)

Relative humidity: 30% to 75% non-condensing

Atmospheric pressure: 700 to 1.060 hPa

An abrupt change in temperature is to be avoided as condensation may arise in the unit. Only operate the unit after the temperature has been equalized.

Technical Specifications

Channel Twin-channel, insulated between channels

Modes of operation Continuous, Burst, Modulation

Pulse intensity Adjustable 0-80mA, peak level at 500 Ω load for each channel, constant current

Pulse frequency 2Hz - 150Hz (adjustable)

Pulse width 30μs - 260μs (adjustable)

Timer Continuous, 15 Min., 30 Min.

Burst mode The burst consists of 2 bursts at 100 Hz

Wave form Asymmetrical bi-phase square pulse

Voltage 0-100 Volts (open circuit)

Power supply 9 Volt battery (alkaline battery or rechargeable Nickel-Cadmium battery)

Current consumption 30 mA max.

Dimensions 95 (H) × 65 (W) × 24 (D) mm

Weight 115 grammes (including battery)

SPECIFICATIONS

V	V	o
mA Milliamps
mW Milliwatts
Hz Hertz
μs Micro second
Kilo-Ohms
P Output rating
==	Direct Current

Certification:

promed Promed GmbH, D-82490 Farchant, Germany Tens 1000 s Well-Life Healthcare Inc. 1 Fl., No.16, Lane 454, Jungjeng Road, Yunghe District New Taipei City, 23455, Taiwan

Classification label: - 0020

ACCESSORIES

The tens 1000 s package includes a pack of self-adhesive cloth electrodes of the size 40 x 40 mm ①. For the various areas of application, we offer a range of optional electrode sizes that

can be purchased at specialist stores in accordance with your doctor's recommendations.

Self-adhesive cloth electrodes

Tens contact gel

1 Pack (40 x 40 mm)

included with

the unit!

	1	2	3	4	5
Size:	40 x 40 mm	45 x 35 mm	ø 32 mm	45 x 80 mm	45 x 45 mm	50 g tube
Material:	2838-SE	2838-SE	2838-SE	2838-SE	2838-SE
No. of units/pack:	4	4	4	4	4
Article-No.:	359170	359172	359177	359178	359171	359910

INDICATIONS / CONTRE-INDICATIONS

RECOMMANDATIONS DU MÉDECI

Modulation: O B O N O M

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Line drawings of a human figure in four different views: front, back, side, and lateral (no text or symbols)

INFORMATIONS CONCERNANT LE FONCTIONNEMENT SUR PILE ET PILE RECHARGEABLE

Remplacer la pile / pile rechargeable

promed Promed GmbH, D-82490 Farchant, Germany Tens 1000 s Well-Life Healthcare Inc. 1 Fl., No.16, Lane 454, Jungjeng Road, Yunghe District New Taipei City, 23455, Taiwan

SCELTA, MANUTENZIONE E USO DEGLI ELETTRODI

Line drawings of a human body in front and back views, showing no text or symbols

CONSIGLI MEDICI

Line drawings of a human body in four sequential views, showing front, back, and side views (no text or symbols)

Dimensioni 95 (A) × 65 (L) × 24 (P) mm

promed Promed GmbH, D-82490 Farchant, Germany Tens 1000 s Well-Life Healthcare Inc. 1 Fl., No.16, Lane 454, Jungjeng Road, Yunghe District New Taipei City, 23455, Taiwan SN 2012-08 CE 0120

Line drawings of a human body in front and back views, showing no text or symbols

Line drawings of a human figure in four different views, showing standing and back angles (no text or symbols)

promed Promed GmbH, D-82490 Farchant, Germany Tens 1000 s Well-Life Healthcare Inc. 1 Fl., No.16, Lane 454, Jungjeng Road, Yunghe District New Taipei City, 23455, Taiwan SN 2012-08 CE 0120

Certificado: - QE20

ACCESSORIOS

Symbol for WARNING! Indicates sections of the user manual that are safety-relevant!

The symbol corresponds to symbol 14, table D1, annex D of the EN 60601-1:1990 Standard. Instructions for a unit, system or accessories contain important safety-relevant information for the consumer.

Symbol for Type BF (body floating) units

The symbol corresponds to symbol 2, table D2, annex D of the EN 60601-1:1990 Standard. Appliances that comply with the requirements of this norm offer a higher level of protection against electric shocks, especially when taking into account the permissible patient leakage currents and safety of the user.

Please note the symbol for instruction manual:

The symbol corresponds to the symbol of safety 01 the standard IEC 60878 as well as symbol 10, Table D2, Annexe D the standard IEC 60601-1:2005. The instruction manual must be followed effectively.

EXPLICATION DES SYMBOLES

Symbol for Manufacturer and manufacturing Factory

The symbol corresponds to symbol 5.12 of the EN 980:2008 Standard. It shows the name and the address of the manufacturer and the manufacturing factory.

Symbol for date of manufacture

The symbol corresponds to symbol 5.6 of the EN 980:2008 Standard. It shows the date of manufactur.

Symbol for Notified Body

This Symbol Complies with the European Medical Device Directive 93/42/EEC and amended by directive 2007/47/EC requirements. Notified body TUV South (0120).

Symbol for Authorized representative in the European Community

The symbol corresponds to symbol 5.13 of the EN 980:2008 Standard. It shows the Name of Authorized representative in the European Community.

EXPLICATION DES SYMBOLES

Symbole Notified Body

The unit is equipped with radio interference suppression in accordance with the EC Directive 87/308/EC.
CE in accordance with EC Directive
93/42/EEC, 2009/125/EC,
87/308/EC, 2006/95/EC,
2004/108/EC, 2002/95/EC,
1907/2006/EC and 2005/69/EC.
The requirements of the EC Directive
93/42/EEC for class II medical
products has been fulfilled.
Appliance classification: Class IIa Standards applied:
EN 55011:1998 +A1:1999 +A2:2002
EN 60601-1:2002
EN 61000-3-2:2000 +A2:2005
EN 61000-3-3:1995 A1:2001
IEC 61000-4-2 Edition 1.2:2001-04
IEC 61000-4-3:2002 +A1:2002
IEC 61000-4-4:2002
IEC 61000-4-5 Edition 1.1:2001-04
IEC 61000-4-6 Edition 2.1:2004-11
IEC 61000-4-8 Edition 1.1:2001-03
IEC 61000-4-11
Second Edition:2004-03
09-2 03/2007 MDS-Hi
DIN EN ISO 9001
DIN EN ISO 13485