PinPrick Stimulator Set User manual
Contents
1. INNOVATIVE TREATMENT SOLUTIONS PinPrick Stimulator Set Tactile stimulators for quantitative sensoric testing QST MR compatible version User manual 1 Intended use The PinPrick or punctate needle stimulators enable the application of reproducible tactile mechanical stimuli on the human skin They are manually applied on different areas of the body The stimulation is solely based on the force of freely movable weights inside the guiding tubes The different weights result in different stimulus intensities One set includes seven PinPrick stimulators with logarithmically staggered weights The tips of the PinPrick stimulators have a uniform geometry In addition three different stimulators for light and stroking tactile stimuli are provided By means of the different standardized stimulators a quantitative sensoric testing QST of the individual tactile mechanical sensitivity of pain gets possible The uniform needle geometry and the defined weights guarantee the comparability of test results with different persons and by different operators This user manual describes the parts and the application of the PinPrick stimulators and the accessories 2 Safety instructions e The main risk of the PinPrick stimulator application is the unintended penetration of the needle through the patient s or subject s skin The stimulators are designed in that way that a penetration of the skin should not occur even with the bigg2. movement onto the respective area of the skin Swinging placement can affect the effective force impact Do not use more than 256 mN if you apply the PinPrick stimulators in the face Do not use more than 128 mN during wind up measurements in the face Do not push the PinPrick stimulators onto the skin Instead let them act by means of the weight alone Otherwise you could unintentionally penetrate the skin especially if you apply the biggest weight Please take care not to touch the skin with the guiding tubes If you observe any resistance or unusual noise during the application of the PinPrick stimulators the sliding surface of the weight inside the guiding tube could be contaminated or damaged In that case another effective weight as desired will act on the skin Therefore you should once again check the respective stimulator If you can not restore the original behaviour by repeated reciprocating the stimulator you should contact the manufacturer Steam sterilisation can change the sliding characteristics of the mechanical parts and therefore the effective weight The friction force can even increase in that extent that the weights do not move freely anymore Please consider the notes regarding disinfection and sterilisation in this user manual Therefore please check the sliding characteristics of the stimulators after each sterilisation before you apply them to the skin In any case please consider the notes and instructions in this u
3. Bunte StraBe 10 D 69123 Heidelberg Germany Phone 49 6221 13803 00 Fax 49 6221 13803 01 E mail info mrc systems de MRC Systems GmbH version 3 25 07 2013 page 11 of 13 9 Summary of Warning Notes MRC Systems GmbH The PinPrick stimulators should be disinfected before each application Do not touch any injured or morbid skin with the stimulators The needles of the PinPrick stimulators are delicate mechanical components that can be easily deformed by incorrect handling and or tilted application of a force Please do not press them transversely onto hard objects Please do not let them fall down If a needle is anyhow deformed please contact the manufacturer before your next application The needle should already be in the outward position before the PinPrick stimulators are applied onto the skin Therefore move the PinPrick stimulators in the upright position before the application Move them in your hand so that the weight slides up and down in order to release any resistance Otherwise if the needle slides out of the guiding tube in an uncontrolled manner you can cause lesions of the patient or subject a deformation of the needle and or damage of the needle s tip Always place the needle onto the skin in upright orientation Otherwise you will apply another effective weight or another tip geometry as desired In that case the comparability of the measurements will be affected Place the PinPrick stimulators in a smooth
4. d as a clock during wind up measurements Korg MA 1 box user manual with test certificate Please do not place any objects into this compartment y metronome pinprick stimulators This area is intentionally left stimulators free to make for light sure that moved tactile out needles are stimuli not deformed l i 1 j Figure 1 Complete PinPrick stimulator set MRC Systems GmbH version 3 25 07 2013 page 3 of 13 INNOVATIVE TREATMENT SOLUTIONS 4 Instructions for use 4 1 Before the first use Before you use the PinPrick stimulators for the first time you should familiarize yourself with their behaviour For this purpose carefully take the 64 mN stimulator out of the box by handling it approximately in the middle of the guiding tube First keep it in a preferably horizontal position Then move it slowly into the vertical and experience how the needle slowly slides out of the guiding tube by means of the weight In the maximum position the needle protrudes about 25 mm out of the tube before it is blocked by an internal stop By swaying the stimulator between the vertical and the horizontal orientation you can slide the needle in and out of the tube Repeat this procedure with all PinPrick stimulators first to experience the sliding characteristics of each stimulator second to check if all needles are moving smoothly The needles of the PinPrick stimulators are delicate mechanical components
5. est weight if the instructions in this manual are considered especially with respect to handling and cleaning Do not touch any injured or morbid skin with the stimulators Do not use more than 256 mN if you apply the PinPrick stimulators in the face Do not use more than 128 mN during wind up measurements in the face Do not push the PinPrick stimulators onto the skin Instead let them act by means of the weight alone Otherwise you could unintentionally penetrate the skin especially if you apply the biggest weight Please take care not to touch the skin with the guiding tubes MR compatible version The stimulators are made of materials that can be used inside the bore of MRI scanners during imaging However they include metallic parts and can experience forces due to the magnetic and electric fields in the scanner Therefore the stimulators should not be let loose whenever they are close to the patient or subject e The needles are made of titanium which is a less firm material compared to stainless steel Thus please take care not to bend the needles or damage the tip MRC Systems GmbH version 3 25 07 2013 page 2 of 13 INNOVATIVE TREATMENT SOLUTIONS 3 Set components 7 different PinPrick stimulators for different standardized stimuli set for light tactile stimuli e brush SenseLab Brush 05 cotton bud B ttger 09 143 9105 e piece of cotton wool Q tip attached to an elastic plastic strip metronome use
6. he skin MRC Systems GmbH version 3 25 07 2013 page 4 of 13 INNOVATIVE TREATMENT SOLUTIONS 1 500 1 000 Zz E 500 2 LL 0 500 0 2 5 5 0 75 10 0 Time s 1 500 1 000 Z E 500 2 fe LL 0 500 0 2 5 5 0 7 5 10 0 Time s Figure 2 Diagram of forces resulting from different movement velocities of the PinPrick stimulators single stimulus application In the upper recording the stimulators of 64 mN and 256 mN have been applied correctly In the lower recording the 256 mN stimulator generated an unintended impulse since it was applied with too much power MRC Systems GmbH version 3 25 07 2013 page 5 of 13 INNOVATIVE TREATMENT SOLUTIONS 1 500 1 000 Zz amp 500 eb 2 O LL 0 500 I 0 2 5 5 0 75 10 0 12 5 15 0 17 5 20 0 Time s 1 500 1 000 Zz E 500 eb 2 O LL 0 500 0 2 5 5 0 75 10 0 12 5 15 0 17 5 200 Time s Figure 3 Diagram of wind up measurements with correct top and too swinging bottom power MRC Systems GmbH version 3 25 07 2013 page 6 of 13 INNOVATIVE TREATMENT SOLUTIONS e The needle should already be in the outward position before the PinPrick stimulators are applied onto the skin Therefore move the PinPrick stimulators in the upright position before the application Move them in your hand so that the weight slides up and down in order to release any resistance Otherwise if the needle slides out of the guiding tube in an uncon
7. ia or a hypoalgesia or a mechanical allodynia The stimulators for light tactile stimuli are moved in a single stroking movement over the skin 1 2 cm in length Please apply the cotton wool in that way that the plastic strip is slightly bent The elastic force of the plastic strip was designed in that way that the resulting pressure will then be in a range of 100 mN The B ttger cotton tab was selected to enable a smooth force of about 3 mN in stroking application The stimulation intensity of the Brush 05 is in the range of 200 400 mN The patients or subjects shall verbally rate the stimulus intensity with a number 0 100 Here 0 stands for no pain which is not the same as not noticed If a stimulus is not recognized at all it should be marked as 100 corresponds to the maximum pain which can be imagined by the MRC Systems GmbH version 3 25 07 2013 page 7 of 13 INNOVATIVE TREATMENT SOLUTIONS person d as 100 corresponds to the maximum pain which can be imagined by the person Literature 1 LaMotte et al 1991 2 Ziegler et al 1999 c Wind up In this test a single stimulus is applied by means of the 256 mN PinPrick stimulator Then after a period of 10 seconds a series of ten identical punctate stimuli with a frequency of 1 Hz is applied in the same skin area The size of this area should be about 1 cm Immediately after the single stimulus and again after the subsequent
8. on Tests have shown that it is also possible to use heat sterilisation in the autoclave However in this case the last step of the process has to be a drying step Otherwise the sliding characteristics of the PinPrick stimulators can be affected MRC Systems GmbH version 3 25 07 2013 page 8 of 13 INNOVATIVE TREATMENT SOLUTIONS 5 2 Maintenance Please take care for a generally clean status of the stimulators Keep them in the box included in delivery Contaminated stimulators should be cleaned with a dry cloth Please pay attention that 1 no liquid is entering into the guiding tubes since this can affect the sliding characteristics 2 the needles are not deformed MRC Systems GmbH version 3 25 07 2013 page 9 of 13 6 Technical data INNOVATIVE TREATMENT SOLUTIONS stimulus intensity PinPrick stimulators 8 16 32 64 128 256 512 mN brush SenseLab Brush 05 200 400 mN cotton bud B ttger 09 143 9105 3mN cotton wool Q Tip on plastic strip 100 mN All weights have been checked before delivery by means of force sensors needle tip geometry flat contact area diameter 0 25 mm radius of curvature 5 0 5 um length of needle 19 5 mm material titanium support PEEK MR compatible version guiding tube diameter 11 mm MR compatible version material titantum MR compatible version weight set with 7 PinPrick stimulators 960 g metronome Korg MA 1 see
9. ser manual version 3 25 07 2013 page 12 of 13 MRC Systems GmbH version 3 25 07 2013 page 13 of 13
10. series of stimuli a summarizing rating is performed by means of a numerical scale From the recorded rating of the stimulus intensity the ratio between the rating for the single stimulus and the series of stimuli is calculated This is usually done in five repetitions The geometrical average of all ratios is the wind up value Literature 1 Price et al 1977 2 Magerl et al 1998 More information about QST applications can be found on the website www neuro med tu muenchen de dfns patienten QST html 5 Dinsinfection and maintenance instructions 5 1 Disinfection sterilisation The application of the PinPrick stimulators is a non invasive procedure We have already indicated in the safety instructions that there is an improbable residual risk of penetration through the skin Therefore as an additional safety measure for minimizing the risk of infection you should clean the needles before each application Please use an appropriate disinfection spray The PinPrick stimulators should be disinfected before each application The needles of the PinPrick stimulators are delicate mechanical components that can be easily deformed by incorrect handling and or tilted application of a force Please do not press them transversely onto hard objects Please do not let them fall down If a needle is anyhow deformed please contact the manufacturer before your next application For sterilisation we recommend to use chemical sterilisati
11. that can be easily deformed by incorrect handling and or tilted application of a force Please do not press them transversely onto hard objects Please do not let them fall down If a needle is anyhow deformed please contact the manufacturer before your next application 4 2 Correct application of the PinPrick stimulators The significance of the pain threshold determination with PinPrick stimulators critically depends on their reproducible application The following aspects are of special importance in this context 1 a comparable contact area between tip and skin 2 a consistent effective weight 3 a comparable movement of the needle onto the skin The first two aspects are intuitively clear since they have a direct influence on the person s sensitivity The reproducibility is achieved by the uniform tip geometry and the calibrated weights However in order to actually apply the identical tip geometry and the correct weight you have to apply the stimulators in upright orientation and orthogonal direction to the skin The third aspect shall be further explained by figures 2 and 3 The figures show the forces which have been measured by a force sensor when the PinPrick stimulators have been applied with different velocities and in differently swinging movements It gets obvious that the effective force strongly varies with the movement characteristics Therefore please take care for a smooth and uninterrupted movement of the stimulators onto t
12. the user manual in the metronome packing 500 400 300 200 100 0 Figure 4 Recording of forces from left to right cotton bud B ttger 09 143 9105 Q Tip on plastic strip and MRC Systems GmbH SenseLab Brush 05 version 3 25 07 2013 page 10 of 13 INNOVATIVE TREATMENT SOLUTIONS 7 Safety The PinPrick stimulator set has left our firm in a faultless state In order to maintain this state you should always store the stimulators in the delivered box in dry environments has been tested according to the requirements of our certified quality management in The product is a class 1 product in terms of the medical device directive MDD It C compliance with the standard EN ISO 13485 7 1 Marking Each PinPrick stimulator is marked with the lettering The PIN PRICK the characterizing weight a serial number and the CE mark The marking is engraved into the guiding tube serial number CE mark Figure 5 Marking of a PinPrick stimulator 7 2 Service The sliding characteristics of the internal weights can change due to changes of the surface quality mechanical distortion or dirt Therefore we recommend to check the PinPrick stimulators in periodic intervals of at least two years better one year Please contact the manufacturer who can perform these calibration measurements We have appropriate measurement devices available and can issue a test certificate 8 Contact MRC Systems GmbH Hans
13. trolled manner you can cause lesions of the patient or subject a deformation of the needle and or damage of the needle s tip Always place the needle onto the skin in upright orientation Otherwise you will apply another effective weight or another tip geometry as desired In that case the comparability of the measurements will be affected e Place the PinPrick stimulators in a smooth movement onto the respective area of the skin Swinging placement can affect the effective force impact 4 3 QST applications The stimulators are used for different quantitative sensoric testing QST procedures as recommended by e g the German Research Network on Neurophathic Pain DFNS or other European collaborations a Determination of the mechanical pain threshold The standardized PinPrick needles enable the determination of the mechanical pain threshold by means of a modified method of limits For this purpose the geometrical average of the mechanical pain threshold is calculated from usually five series of ascending and descending stimulus intensities Literature 1 Chan et al 1992 2 Greenspan and McGillis 1994 3 Hampf et al 1990 4 Ziegler et al 1999 b Determination of the mechanical pain sensitivity of the skin and the mechanical allodynia with moving stimuli Here the stimuli are applied in a balanced series After determination of the stimulus response function you can find out whether or not there is a hyperalges
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