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Guidance and Manufacturer’s Declaration – Electromagnetic Immunity

ARTROMOT® ACTIVE-K

is intended for use in the electromagnetic environment specified below. It

is the responsibility of the customer or user to ensure that the

ARTROMOT® ACTIVE-K

unit is used in

such an environment.

Immunity test

IEC 60601 test level Compliance level Electromagnetic environ-

ment - guidance

Portable and mobile RF com-

munications equipment should

be used no closer to any part

of the ARTROMOT® ACTIVE-K

unit, including cables, than

the recommended separation

distance calculated from the

equation applicable to the

frequency of the transmitter.
Recommended separation

distance:

Conducted RF to

IEC 61000-4-6

3 V

rms

150 kHz to 80 MHz

3 V

rms

d = 1.2 √P
d = 1.2 √P at 80 MHz to 800 MHz
d = 2.3 √P at 800 MHz to 2.5 GHz
where P is the maximum out-

put power rating of the trans-

mitter in watts (W) according

to the transmitter manufacturer

and d is the recommended

separation distance in meters

(m).

Radiated RF to

IEC 61000-4-3

3 V/m

80 MHz to 2.5 GHz

3 V/m

Field strengths from fixed RF

transmitters, as determined

by an electromagnetic site

survey

, should be less than

the compliance level in each

frequency range

Interference may occur in the

vicinity of equipment

marked with the following

symbol

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

NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by

absorption and reflection from structures, objects, and people.

a) Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and

land mobile radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with

accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic

site survey should be considered. If the measured field strength in the location in which the

ARTRO-

MOT® ACTIVE-K

exceeds the applicable

ARTROMOT® ACTIVE-K

unit should be observed to verify

normal operation. If abnormal performance is observed, additional measures may be necessary, such as

reorienting or relocating the

ARTROMOT® ACTIVE-K

unit.

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

Supplied by EME Services Ltd

Содержание Artromot Active-K

Страница 1: ...ARTROMOT ACTIVE K CPM CAM Coordination US GB Operating Instructions SW2 X Oper ating Instructions Supplied by EME Services Ltd ...

Страница 2: ...otplate 18 5 Setting the treatment values 20 5 1 General information on programming ARTROMOT ACTIVE K 20 5 2 Therapy parameter details 22 5 3 Other functions settings 30 6 Operating mode details 46 6 1 Passive operating mode CPM 46 6 2 Active operating mode CAM 48 6 3 Coordination mode 51 7 Care Maintenance Transport 63 7 1 Care 63 7 2 Maintenance fuse replacement 63 7 3 Transport 64 8 Environment...

Страница 3: ...early stage and thus improve coordination following joint surgery Other objectives of therapy include improvement of joint metabolism prevention of joint stiffness promotion of the regeneration and healing of cartilage and damaged ligaments faster hematoma fluid resorption improved lymph and blood circulation thrombosis and embolism prophylaxis bridging the gap between passive motion and active tr...

Страница 4: ...the physiotherapy unit comes with special protocols to enhance proprioception i e coordination and functional stability at an early stage These are some of the ARTROMOT ACTIVE K features anatomically correct setup physiological movements control pendant for precise adjustment of patient specific therapy values symbols for easy operation of the control pendant chip card for storage of the programme...

Страница 5: ...ot to the footplate 12 Footplate 13 Locking screw for adjustment of the foot plate height 14 Clamping lever to adjust the footplate rotation 15 Sensor for measurement of the exerted force 16 Connection for ARTROSTIM FOCUSplus control cable 17 Connection for control pendant 18 Connection for power cord 19 Instrument fuse 20 Power switch ON OFF 21 Rating plate 22 Control pendant 23 Patient chip card...

Страница 6: ... field for selection of a function down decreases values during setup deactivates functions OK button confirms a selection confirms a setting STOP button stops a treatment and saves the values MENU button displays the menu for setting the therapy parameters in each operating mode Arrow up moves the focus blue field for selection of a function up increases values during setup activates functions Ar...

Страница 7: ...3 Control pendant in parameter programming mode Selected operating mode here passive CPM and operating mode reference number here 1 1 Selected parameter here setting for passive extension Status of the selected function here exten sion angle Symbol for selected parameter here setting for passive extension Additional information Appears only when needed here current ROM limits blue adjustable value...

Страница 8: ...function Arrow down deactivates the function OK saves the setting Symbol for selected parameter here warm up protocol Status of the selected function here warm up protocol inactive When the function is activated the square is solid green and displays a check mark 2 2 4 Control pendant in programming mode for functions that can be activated Supplied by EME Services Ltd ...

Страница 9: ...tive Free training Therapy protocols Cruciate ligament ACL PCL Cartilage Total knee hip replacement TEP Level selection Demo Adjustable parameters Passive exten sion stretching adjustment Passive flex ion bending adjustment Active adjustment range of motion ROM Timer therapy timer Speed Warm up protocol passive Extension pause Flexion pause Muscle stimulation Load reversal Extension force Flexion ...

Страница 10: ...herapy documentation Settings Language selection Brightness Volume Time date Transport Total unit run time Service menu Lock out function Lock out function disabled Lock out function enabled Level 1 Lock out function enabled Level 2 Lock out function enabled Level 3 Lock out function enabled Level 4 Supplied by EME Services Ltd ...

Страница 11: ...switch OFF power switch ON The number next to this factory symbol is the year of manufacture The name next to this factory symbol is the manufacturer The number next to this symbol is the article reference number Device complies with Council Directive 93 42 EEC about medical devices tested and approved by DQS Medizinprodukte GmbH The number next to this symbol is the serial number m Caution Observ...

Страница 12: ... finger Protection against foreign object protected against solid foreign object diameter of 12 5 mm and greater 1 indicates the degree of protection against water The digit 1 means protection against vertically falling water drops 3V type CR2032 Not user replaceable Contact Technical Service Warning symbol pinch point hazard Warning Depending on the device settings the moving parts of the device ...

Страница 13: ...ned Stop therapy immediately when you have doubts about the device settings and or the therapy protocol It is important that the patient s position is anatomically correct Therefore carefully verify the following settings positions 1 femur length 2 knee joint axis 3 tibia length and leg rotation 4 leg support assemblies Movements must not cause pain or irritation Patients must be fully conscious w...

Страница 14: ...vice is mandatory for their safety Never leave the device unattended when it is switched on Switch the device off and disconnect the power line from the wall outlet After use store the device in a safe place Ensure device stability also during storage This device is not a toy m Warning Shock hazard Strictly observe the following warnings Failure to do so endangers the lives of the patient the user...

Страница 15: ...re parts by authorized staff m Caution Preventing chafing and pressure sores When your patient is adipose very tall or very short be sure to prevent chafing and pressure sores Place the leg concerned in a moderate abductive position if deemed appropriate m Caution Equipment damage Check that the voltage and frequency ratings of your local power line are those indicated on the rating plate The leg ...

Страница 16: ...on of the operating mode Using the arrow buttons move the focus blue field for selection of a function field displayed with a blue frame to highlight the New Patient function Select the function with then acti vate the function by pressing the arrow up button Confirm the selection with The ini tial screen for setting the unit to the home position will be displayed Press The unit automatically ente...

Страница 17: ... to lock 3 Turn on the ARTROMOT ACTIVE K first then turn on the muscle stimulator Note For information on connecting and pro gramming the muscle stimulator refer to the operation manual that comes with the ARTROSTIM FOCUS plus The EMS control function is only available in the passive operating mode The ARTROMOT ACTIVE K only synchro nizes motion therapy and electrotherapy the therapy parameters mu...

Страница 18: ... to the patient Figs D and E Fig D Fig E To adjust the height of the support as semblies for calf 6 and thigh 1 loosen clamping levers 2 and 7 Figs F and G Fig F Fig G 2 Place the patient s leg on the carriage and repeat the steps outlined under 1 above to adjust the unit to the patient m Caution Equipment damage Cover the leg support assemblies with disposable tissues when us ing ARTROMOT ACTIVE ...

Страница 19: ... are fitted at the end of the carriage The supports can be folded out to secure the carriage at the end of a therapy couch or bed For this purpose fold the supports down If used in a bed the supports are best placed between the mattress and the bed frame so as to optimally absorb movements of pulling and pushing m Caution Patient hazard The sole purpose of the supports is to secure the unit in the...

Страница 20: ...tom line of symbols The focus highlights the passive operating mode You shift the focus by pressing the appropriate arrow button Select one of the fields and activate the corre sponding setup menu with the MENU button The display will show the available therapy parameters or sub functions and the current selections below the corresponding symbol You select a treatment parameter or function by pres...

Страница 21: ...l automatically change the direction of movement Chip cards The explanations given for the initial adjustment with a new patient are based on the chip card Special With this chip card all available operating modes and functions can be selected To simplify the use of the device the display and choice of operating modes and functions can be limited This is done by inserting dif ferent pre programmed...

Страница 22: ...ynamic Find angle passive Find angle active Free training Passive exten sion stretching adjustment Passive flexion bend ing adjustment Timer therapy timer Speed Warm up protocol passive Extension pause Flexion pause Active adjustment ROM range of motion Muscle stimulation Load reversal Extension force Flexion force Active zone Extension force range Flexion force range Supplied by EME Services Ltd ...

Страница 23: ...ating mode passive or active Default 50 Therapy timer The default setting for the carriage is continuous operation min A clock symbol in the upper right hand corner of the display header identifies the continuous mode of operation The clock indicates the elapsed therapy time In the continuous mode the device must be stopped with the STOP button However you can also select therapy durations of 1 to...

Страница 24: ...es can be set to any value between 0 and 59 seconds in steps of 1 second and to values between 1 and 59 minutes in steps of 1 minute Default no pause Load reversal reverse on load feature for patient safety spasm protection The device automatically starts moving in the opposite direction of the last movement when the patient s resistance load exceeds the set force Load reversal is automatically ac...

Страница 25: ... pulse to the ARTROSTIM FOCUS plus device For the dura tion of the stimulation period pause set at the carriage default 20 seconds the muscle stimulation protocol that you programmed at the ARTROSTIM FOCUS plus unit will be completed with the selected intensity for program ming of the EMS device see ARTROSTIM FOCUS plus operation manual After the pause the ARTROMOT ACTIVE K will turn off the EMS d...

Страница 26: ... be adjusted between 30 kg and 30 kg in steps of 1 kg Adjustable forces 0 kg passive mode extension 1 to 30 kg force that the patient is required to exert actively in the direction of motion push so as to move the carriage in the extension direction 1 to 30 kg force that the patient is required to exert actively in the opposite direction of motion pull so as to move the carriage in the extension d...

Страница 27: ...ection of the force will be indicated by an arrow in the field of the corresponding function and in addition to the indication Active zone The active zone determines the extension and flexion range in which the patient can exercise in the active mode During operation this range is always at least 5 less than the current extension and flexion ROMs These 5 in extension and flexion are executed in th...

Страница 28: ...ts of the force range from which a random resistance is selected that the patient is required to overcome actively in the direction of motion push so as to move the carriage in the extension direction 1 to 30 kg limits of the force range from which a random resistance is selected that the patient is required to overcome actively opposite to the direction of motion pull so as to move the carriage i...

Страница 29: ... of the force range from which a random resistance is selected that the patient is required to overcome actively opposite to the direction of motion push so as to move the carriage in the flexion direction 1 to 30 kg limits of the force range from which a random resistance is selected that the patient is required to overcome ac tively in the direction of motion pull so as to move the carriage in t...

Страница 30: ...physician can define how often patients should repeat a level each day sessions day and whether they should exercise at different levels The default therapy duration at each level is 20 minutes minimum setting The maximum duration is 2 hours The duration of the individual steps adapts automatically The duration of the passive warm up step however is fixed as indicated in the table The patient is i...

Страница 31: ... quick rundown of each level of the therapy protocol so that patients learn quickly what the therapy session involves Default disabled To use the function 1 Set the range of motion 2 Select the level 3 Activate the demo function 4 Press the START button Subsequently the following sequences of the respective levels are represented in tabular form Initiate the demo mode with START During the demo mo...

Страница 32: ...t parameters Level 1 5 PASSIVE WARM UP 15 PASSIVE Level 2 5 PASSIVE WARM UP Speed 75 5 ACTIVE ACTIVE ZONE 0 10 60 Extension Push 5 kg Flexion Passive 3 PASSIVE Speed 75 5 ACTIVE See above 2 PASSIVE COOL DOWN Level 3 3 PASSIVE WARM UP Speed 75 5 ACTIVE ACTIVE ZONE 0 0 60 Extension Push 7 kg Flexion Pull 7 kg 5 PASSIVE Speed 75 5 MAINTAIN FORCE STATIC Extension Push 5 kg to 8 kg Flexion Pull 5 kg to...

Страница 33: ...ension Push 3 kg Flexion Pull 3 kg 5 ACTIVE Speed 75 Extension Push 10 kg Flexion Push 8 kg 3 MAINTAIN FORCE STATIC Extension Push 10 kg to 14 kg Flexion Pull 10 kg to 14 kg 5 ACTIVE See above 2 FIND ANGLE ACTIVE Extension Push 3 kg Flexion Pull 3 kg 3 PASSIVE COOL DOWN Level 6 5 FREE TRAINING Extension Push 8 kg Flexion Pull 5 kg 3 PASSIVE 5 FREE TRAINING Extension Push 12 kg Flexion Pull 8 kg 2 ...

Страница 34: ...ength the times may vary Normally the range of motion is set by means of the extension and flexion settings outside the therapy plans If a session starts with the free training function the final extension and flexion values of this phase automatically become the ROM for the rest of the session The operating modes and functions are described in detail in chapter 6 The response threshold of the loa...

Страница 35: ...parameters Level 1 5 PASSIVE WARM UP 15 PASSIVE Level 2 5 PASSIVE WARM UP 5 ACTIVE ACTIVE ZONE limited 0 10 60 Extension Push 5 kg Flexion passive 3 PASSIVE 5 ACTIVE ACTIVE ZONE limited 0 10 60 Extension passive Flexion Pull 5 kg 2 PASSIVE COOL DOWN Level 3 3 PASSIVE WARM UP 5 ACTIVE Extension Push 5 kg Flexion Pull 4 kg 5 PASSIVE 5 ACTIVE Extension Push 8 kg Flexion Pull 4 kg 2 PASSIVE COOL DOWN ...

Страница 36: ...E COOL DOWN Level 5 3 PASSIVE WARM UP 5 ACTIVE Extension Push 7 kg Flexion Pull 7 kg 5 MAINTAIN FORCE STATIC Extension Push 7 to 10 kg Flexion Pull 7 to 10 kg 5 ACTIVE Extension Push 10 kg Flexion Pull 10 kg 2 PASSIVE COOL DOWN Level 6 3 FREE TRAINING Extension Push 3 kg Flexion Pull 3 kg 2 FIND ANGLE ACTIVE Extension Push 5 kg Flexion Pull 5 kg 5 ACTIVE Extension Push 10 kg Flexion Pull 10 kg 3 P...

Страница 37: ...ength the times may vary Normally the range of motion is set by means of the extension and flexion settings outside the therapy plans If a session starts with the free training function the final extension and flexion values of this phase automatically become the ROM for the rest of the session The operating modes and functions are described in detail in chapter 6 The response threshold of the loa...

Страница 38: ...Duration in minutens Function sequence Default parameters Level 1 5 PASSIVE WARM UP 15 PASSIVE Level 2 5 PASSIVE WARM UP 5 ACTIVE Extension Push 4 kg Flexion Pull 4 kg 3 PASSIVE 5 ACTIVE See above 2 PASSIVE COOL DOWN Level 3 3 PASSIVE WARM UP 5 ACTIVE Extension Push 6 kg Flexion Pull 6 kg 5 MAINTAIN FORCE STATIC Extension Push 4 to 7 kg Flexion PASSIVE 5 ACTIVE See above 2 PASSIVE COOL DOWN Suppli...

Страница 39: ... 2 FREE TRAINING Extension Push 3 kg Flexion Pull 3 kg 5 ACTIVE Speed 75 Extension Push 10 kg Flexion Pull 8 kg 5 MAINTAIN FORCE STATIC Extension Push 6 10 kg Flexion Pull 6 10 kg 5 ACTIVE See above 3 PASSIVE COOL DOWN Level 6 5 FREE TRAINING Extension Push 5 kg Flexion Pull 5 kg 5 ACTIVE Speed 75 Extension Push 10 kg Flexion Pull 8 kg 2 FIND ANGLE ACTIVE Extension Push 5 kg Flexion Pull 5 kg 5 AC...

Страница 40: ...ength the times may vary Normally the range of motion is set by means of the extension and flexion settings outside the therapy plans If a session starts with the free training function the final extension and flexion values of this phase automatically become the ROM for the rest of the session The operating modes and functions are described in detail in chapter 6 The response threshold of the loa...

Страница 41: ...n press the START button the carriage enters the home position and existing therapy parameters will be deleted Next you will see the main menu where you can select the operating mode The new patient function home position selects the following settings extension flexion speed extension pause flexion pause timer reverse on load active zone extension force flexion force extension force range flexion...

Страница 42: ... ACTIVE K which allows the entire therapy documentation to be reviewed on the display The recorded data are the carriage run times the range of motion of the sessions the selected mode of operation as well as the forces set at the therapy unit The collected data of the ROM trend are presented graphi cally in a coordinate system X axis range of motion Y axis time where the upper curve illustrates t...

Страница 43: ...ss Default 100 Volume Adjustment of the volume of audio signals 0 no audio signal Default 100 Time date Adjustment of the carriage s internal clock Adjustable parameters time in hh mm date in dd mm yy Transport setting With this function the carriage will automatically move to a position optimally suited for packing the therapy unit Press the OK button to select the function press the arrow up but...

Страница 44: ... Deleting the stored therapy time Select the function with the OK button the stored period of time will be displayed with large digits To delete the value press the arrow down button and confirm with OK The total unit run time cannot be deleted with the New Patient function Service menu For service purposes only refer to Service Manual Supplied by EME Services Ltd ...

Страница 45: ...ted and modified 2 Level 2 of the lock out feature is enabled Same as lock out level 1 Additionally it is not possible to switch between the different proto cols of the coordination and therapy protocol modes such as between ACL and Cartilage or between Find angle active and Find angle passive However all parameters of the operat ing mode protocol can be selected and modified 3 Level 3 of the lock...

Страница 46: ...ynamic find angle passive find angle active free training 6 1 Passive operating mode CPM The passive operating mode is intended for early mobilization of the knee and hip joints by CPM therapy Continuous Passive Motion This is the symbol for the CPM mode 6 1 1 Adjustable CPM parameters Passive extension stretching adjustment Passive flexion bending adjustment Therapy timer Speed Warm up protocol p...

Страница 47: ...0 0 120 set extension angle here 5 current position of the carriage in relation to the overall ROM here 23 set flexion angle here 80 elapsed therapy time OR if the timer is activated remaining therapy time dialog field indication current position of the carriage here 23 current direc tion of the carriage here extension Supplied by EME Services Ltd ...

Страница 48: ...l always be performed in the passive mode Example of a range of motion smaller than the preset active zone Set range of motion 0 10 60 Set active zone 0 0 90 maximum setting True active zone 0 15 55 Extension force 10 kg Flexion force 5 kg This is what the settings mean Although the active zone is larger than the current range of motion the patient will only be able to actively exercise within the...

Страница 49: ...can be adjusted Passive extension stretching adjustment Passive flexion bending adjustment Therapy timer Speed Warm up protocol passive Extension pause Flexion pause Active adjustment ROM range of motion Extension force Flexion force Active zone Load reversal passive Supplied by EME Services Ltd ...

Страница 50: ...n to the overall ROM here 41 set flexion angle here 80 elapsed therapy time OR if the timer is activated remaining therapy time dialog field indication of the direction in which the requested force indication of the overall available ROM 10 0 120 current direc tion of the carriage here extension Note In addition to the data on the display the force exerted in the active mode is indicated by an LED...

Страница 51: ...an that the patient is required to pull to overcome the set resis tance irrespective of the current direction of motion Positive values resistances between 1 kg and 30 kg mean that the patient is required to push to overcome the set resistance irrespective of the set direction of motion If no resistance is set the carriage will operate in the passive mode moving in the direction of extension or fl...

Страница 52: ... Contrary to the Maintain force static function however the patient will continue to move the carriage actively dynamic A progress bar in the dialog window indicates the elapsed time The progress bar fills only as long as the patient exerts the required force When the progress bar is filled after a total of 4 seconds of exerted force the passive move ment of the joint is continued in the current d...

Страница 53: ...ve of the set direction of motion If no resistance is set the carriage will operate in the passive mode moving in the direction of extension or flexion When you adjust the force range the minimum value is shown on the left of the display and the maximum value is shown on the right The random values are selected from this range only It is not possible to define a range that spans the value of 0 kg ...

Страница 54: ...e The display is essentially the same as in the active mode In addition a progress indicator is shown in the dialog window below the arrow indicating the direction of the requested force progress bar completely filled out 4 seconds Supplied by EME Services Ltd ...

Страница 55: ...o the angle wanted If the deviation is within the tolerance of 10 the attempt was successful and a positive feedback icon is displayed If the deviation is outside the tolerance of 10 the attempt failed and a negative feedback icon is displayed The number of successful and failed attempts is permanently displayed for reference At the end of the session the patient can assess his success and compare...

Страница 56: ...eatment parameters can be adjusted in the Find angle passive coordina tion protocols Passive extension stretching adjustment Passive flexion bending adjustment Therapy timer Speed Warm up protocol passive Active adjustment ROM range of motion Load reversal passive Supplied by EME Services Ltd ...

Страница 57: ...ng adjustment of the maximum extension and flexion angles the angles to attain within the ROM are marked yellow on the ROM bar indicator indication of the angles to find within the current ROM during adjustment of the extension angle here 15 30 45 60 with an increasing ROM further angles will be displayed as soon as they come to lie within the range Supplied by EME Services Ltd ...

Страница 58: ...he current angle to find prompt to find angles and to press OK when done indication blinking indication of the currently set ROM while the patient is trying to find the angle the current position will not be indicated elapsed therapy time OR if the timer is activated remaining therapy time symbol indicat ing the angle to find Supplied by EME Services Ltd ...

Страница 59: ...s and deviation here 60 requested stopped at 50 deviation 10 prompt to press OK to continue the treatment indication blinking rating sum of successful failed attempts indication of the deviation angle wanted angle attained in graphic form here 60 requested stopped at 50 deviation 10 marked red Supplied by EME Services Ltd ...

Страница 60: ...stance can be set and the car riage requests an angle with each movement With this protocol the active zone is the entire range of motion Further limitations do not apply 6 3 3 1 Adjustable parameters in the Find angle active protocol The following treatment parameters can be adjusted in the Find angle active coordination protocols Passive extension stretching adjustment Passive flexion bending ad...

Страница 61: ...rompted to actively bend and extend the knee The maximum extension and flexion angles at tained will be displayed The purpose of the exercises is to expand the range of motion In addition a resistance can be set which the patient must overcome The resistance is effec tive in the direction of motion flexion pull extension push This is the symbol for the free training protocol 6 3 4 1 Adjustable par...

Страница 62: ... dialog field with prompt to bend and stretch actively indication of the maximum flexion angle attained shown graphically and as a numeric value here 80 indication of the maximum extension angle attained shown graphically and as a numeric value here 5 positive feedback when the angle reached is greater than in the previ ous attempt current position of the carriage shown graphi cally and as a numer...

Страница 63: ... not expose the therapy unit to strong ultraviolet radiation sunlight and fire 7 2 Maintenance fuse replacement Check before each use Visually inspect the device for signs of me chanical damage before each use If you detect damage or malfunctions that may impair the safety of the patient or of the operator have the device repaired before using it Technical inspections For safety the devices requir...

Страница 64: ...iththe arrow up but ton and confirming the selection with OK 3 The initial screen will automatically be dis played allowing the carriage to be moved to the transport position Press START and the carriage will automatically move to the transport setting 4 Turn off the ARTROMOT ACTIVE K power switch 20 5 Disconnect the power cord and the control pendant 6 Remove the footplate by fully opening and un...

Страница 65: ...rance 15 to 10 Current consumption standby ON operation maximum 100V 240V 5VA 5VA 85VA 90VA 850mA 370mA Fuses serial number 2 000 2x T1A L250Vac interrupting rating 35A according to IEC 60127 2 3 UL 248 14 CSA C22 2 no 248 14 serial number 2 000 2x T2A L250Vac interrupting rating 35A according to IEC 60127 2 3 UL 248 14 CSA C22 2 no 248 14 Battery type CR2032 3V 230 mAh cannot be replaced by the u...

Страница 66: ...1 1 2005 S 2 000 IEC 60601 1 6 2006 IEC 60601 1 9 2007 IEC 60601 1 11 2010 S 2 000 IEC 62366 2007 IEC 62304 2006 EN ISO 14971 2007 ANSI AAMI ES 60601 1 1st Edition CAN CSA 22 2 No 60601 1 08 EMC electromagnetic compatibility EN 60601 1 2 2007 Manufactured in compliance with EN ISO 13485 2003 AC 2009 Ambient conditions storage transport temperature relative humidity atmospheric pressure 25 C to 70 ...

Страница 67: ...l system the programming unit incl the coiled cable and the connector The product designation ARTROMOT ACTIVE K used in the text below includes all product variants 10 IEC 60601 1 2 2007 and IEC 60601 1 11 2010 10 1 Electromagnetic emissions Guidance and Manufacturer s Declaration Electromagnetic Emissions ARTROMOT ACTIVE K is intended for use in the electromagnetic environment specified below It ...

Страница 68: ... to line voltage 2 kV line to earth voltage 1 kV line to line voltage 2 kV line to earth voltage Mains power should be that of a typical com mercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines to IEC 61 000 4 11 5 UT 95 dip in UT for cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in UT for 5 s 5 UT ...

Страница 69: ...d strengths from fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected...

Страница 70: ... 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the trans mitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 2 5 GHz the higher...

Страница 71: ...y GU2 8XG United Kingdom Phone 44 0 1483 459659 Fax 44 0 1483 459470 e mail info DJOglobal eu Web www DJOglobal eu DJO Global Headquarters DJO LLC 1430 Decision Street 92081 Vista California USA Phone 1 760 727 1280 Fax 1 800 936 6569 e mail webmaster DJOglobal com Web www DJOglobal com Manufacturer Headquarters Germany DJO Global ORMED GmbH Merzhauser Strasse 112 79100 Freiburg Germany Phone 49 0...

Страница 72: ...e original shipping box These boxes can be obtained from DJO Global Before packing the therapy unit set it to the transport position see chapter 7 12 3 Spare parts Refer to the Service Manual for the most recent list of spare parts When ordering spare parts always specify Item Description Part number Qty Serial number of the device Note Refer repairs to authorized specially trained staff ORMED Gmb...

Страница 73: ... green CAM functions only 0 0040 211 Protocol orange therapy plans only 0 0040 212 Special red free programming 0 0040 213 2 Marker pen for patient chip card 0 0031 006 3 Connection cable for muscle stimulator 2 0037 024 4 Strap fixation set 0 0040 100 13 Accessories and Parts for Use with the Device Supplied by EME Services Ltd ...

Страница 74: ...th reference to Rule 9 of the Directive 93 42 EEC the product is a device of risk class IIa Notified body DQS Medizinprodukte GmbH August Schanz Str 21 60433 Frankfurt am Main Germany 0297 Freiburg 31 January 2013 QA Management Representative Bernhard Krohne This certificate is valid until expiry of the certificate referred to the certificate can be downloaded from https de dqs ul com kunden kunde...

Страница 75: ... 03 03 2013 DIN EN 13485 ORMED Nr 018 829 01 Manufacturer ORMED GmbH Merzhauser Str 112 79100 Freiburg Germany Tel 49 761 4566 01 Fax 49 761 4566 5501 medizintechnik DJOglobal com www DJOglobal de Supplied by EME Services Ltd ...

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