Multistim Vario Instruction Booklet April 2010

XS190055G Multistim_CE0124 12.05.10 09:59 Seite 12

GB/US

1 Pre-operational check According to MDD (Medical Device Directive) the MultiStim appliances are classified as IIa products and are intended for identification of peripheral nerves in conduction anaesthesia.In addition, the VARIO device can be used for percutaneous stimulation in neuromuscular monitoring in general anaesthesia. Such devices may only be operated if the supplier 1. has performed a functional test of the device at the place of operation, and 2. has familiarized the person responsible for the operation of the device with the usage of this apparatus by referring to the operating instructions. Please go through the following checking procedure before putting the device into service: 1. Press the ON-button to start the device. The device will then automatically conduct a self-test. Hereby all the segments of the LCD are switched on for visual control. After successful completion of the self-test the device immediately moves on to the normal operational mode. The LCD display will inform you about the current settings. In case the display should not be visible after switching on, change the battery immediately. (Observe section 6 The battery). If the self-test should identify a faulty function, the corresponding error code will be indicated on the

Fig. 1

Fig. 2

LCD. After this occurrence the device is not operational any more! (Observe section 5 Error messages). 2. Check the electrode cable by visual inspection. Damaged cables may not be used. Attach the electrode cable at the top end of the MultiStim device as follows: turn the grooved ring on the plug of the electrode cable so that the two white markings on the plug are aligned. In this position, insert the plug into the connect-ing jack on the device so that the white marking on the device socket is aligned to the white markings on the plug of the electrode cable (see figure 1). The plug can be plugged in only in this position; it may not be inserted in any case by using force! Now turn the grooved ring on the inserted plug of the electrode cable clockwise till you can feel the stop (see figure 2). Hereby the connection issecured, removing the electrode cable unintentionally is prevented. To release the electrode cable, this latching device must be turned counterclockwise till you can feel 12

the stop. Otherwise the electrode cable cannot be removed, or the device or the electrode cable may be damaged! The LCD display exhibits the adjusted setting of the nominal stimulating current. Only for VARIO: the available adjustment range (maximum value) can vary depending on the type of the attached stimulating current cable (6.0 mA or 60.0 mA). 3. Connect the socket of the stimulating electrode to the stimulating electrode clamp with the aid of the supplied red short-circuit plug as illustrated in figure 3 (= short circuit). Select the mode 1 Hz/2 Hz. Then increase the nominal stimulating current by pressing the “+” button to at least 1.0 mA and check the “=” symbol on the display. A few moments after the last depression of the “+” button the display must exhibit an “=”. Analogous behaviour is to be observed when pressing the “–” button. Fig. 3

If the display should permanently show a dissimilar function (“≠” symbol), there must be a fault in the patient stimulating electrical circuit. The enclosed MuliStim-nerve stimulator is equipped with a stimulating-electrode plug, which is protected against accidental contact. In order to conduct the short-circuit-test as described in the Operating Instructions under chapter 1 “Pre-operational check“, please employ the red short-circuit plug supplied with the device as described below. 4. Disconnect the electrical connection to the stimulating cable between the short-circuit plug, which is inserted into the socket of the stimulating electrode, and the stimulating electrode clamp. A “≠” symbol may now be seen on the LCD. This indicates, that the selected nominal stimulating current is dissimilar to the actual stimulating current. If the behaviour is different from the one described in 3 and 4, a faulty stimulating cable could be the cause (short-circuit/interruption). Check the function once more with a second stimulating cable. Finally, remove the red short-circuit plug from the socket of the stimulating electrode. 5. Turn off the MultiStim by pressing the ON/OFF button (observe section 3.1 Switching on and off).

You should turn the device off after use to spare the battery. If you don’t use the device for a longer period of time, you should remove the battery to avoid leakage. 6. Observe section 9. References to hazards before you use the device on a patient. Please observe: Equipment with divergent characteristics may not be taken into operation. Contact the customer service, please. Electromedical pieces of equipment may only be repaired by the manufacturer or an expressly authorized institution. The set stimulation mode remains stored after turning the device off. When the device is switched on again, this setting is reloaded and the stimulation amplitude set to 0.00 mA. The stimulation pulse width for VARIO is preset to the following values after the device is switched on: Mode:

0 – 6 mA 0 – 60 mA

0.1 ms 0.3 ms

Before application on another patient, the device settings have to be checked and altered if necessary.

frequency and a continuously adjustable stimulation current. The adjustment range of the impulse current varies: MultiStim VARIO: for use with stimulation cannulas 0.0 – 6.0 mA in steps of 0.01 mA, percutaneous application 0.0 – 60.0 mA in steps of 0.1 mA; i.e. the adjustment range depends on the type of the attached stimulation cable. MultiStim PLEX: for use with stimulation cannulas 0.0 – 6.0 mA in steps of 0.01 mA. The respective available adjustment range is shown on the display. All set parameters remain stored after turning the device off. For visual and acoustic control the symbol shown here appears synchronous to a short acoustic signal in the stimulating rhythm. The yellow LED-illuminated display above the »+«button signalizes a stimulating current flowing through the stimulation electrodes. In this case the acoustic signal is presented more intensively. On account of a high stimulating tension/voltage of up to 65 V (peak-to-peak), an exceptionally wide adjustment range is available with extremely small stimulating electrodes. When using immoveable body electrodes, ensure that only CE-labeled adhesive stimulation electrodes are used together with contact gel, in order to keep transition resistance as low as possible.

2 Technical description The MultiStim is conceived for the reliable localisation of peripheral nerves for local anaesthesia purposes. This stimulating current device generates reproducible rectangular pulses with an adjustable

2.1 Technical data Type:

MultiStim VARIO

MultiStim PLEX

Type of device: Battery: Permanent current consumption: Stimulating current:

BF 9V 3.3 mA max. 60 mA (peak to peak)/ 0 Ω – 12 kΩ max. 65 V (peak to peak) 1 Hz/2 Hz/50 Hz/100 Hz

BF 9V 3.3 mA max. 6.0 mA (peak to peak)/ 0 Ω – 12 kΩ max. 65 V (peak to peak) 1 Hz/2 Hz

CC 0123

CC 0123

Stimulating tension/voltage: Stimulating frequency:

13

GB/US

XS190055G Multistim_CE0124 12.05.10 09:59 Seite 13

GB/US

XS190055G Multistim_CE0124 12.05.10 09:59 Seite 14

3 Operation of the nerve stimulator

3.4 1 Hz/2 Hz mode

3.1 Switching on and off

When the 1 Hz-/2 Hz button is pressed, MultiStim will generate a continuous sequence of stimulating impulses with a constant frequency. The selected 1 Hz function is displayed on the LCD upon initial activation. Renewed pressing of the 1-Hz-/2-Hzbutton will double the pulse repetition rate to 2 Hz. The nerve stimulator will then continuously generate two impulses per second.

The MultiStim devices can easily be switched on and off by pressing the ON/OFF button. After switching on, the device will first perform an automatic self-test. All segments of the LCD are activated for visual control. Upon the successful completion of the self-test, the device will immediately change to the normal operating state. For the protection of the battery the device will automatically switch itself off with a previous acoustic warning after 20 minutes have elapsed since the last pressing of a button. 3.1.1 VARIO Pressing the ON/OFF/PAUSE button is sufficient to turn the MultiStim VARIO on. The device is turned off by pressing the ON/OFF/PAUSE button for at least two seconds while the device is turned on.

3.5. 50 Hz/100 Hz mode – only VARIO When the 50 Hz-/100 Hz button is pressed, MultiStim VARIO will generate a continuous sequence of stimulating currents with a constant frequency. The selected 50 Hz function is displayed on the LCD upon initial activation. Renewed press-ing of the 50 Hz-/100 Hz button will double the pulse repetition rate to 100 Hz. For safety reasons, this function is only available for the 60 mA range, i.e. when a percutaneous stimulation cable is connected to the device.

3.1.2 PLEX Pressing the ON/OFF button is sufficient to turn the MultiStim PLEX on. The device is turned off by pressing the ON/OFF button briefly while the device is turned on. 3.2 PAUSE function – only VARIO While the device is turned on, a short depression of the ON/OFF/PAUSE button will activate the Pause mode of the MultiStim VARIO. Stimulation is stopped in this condition. To indicate that the device is in the Pause mode, the “=/≠” symbol will disappear and the value of current intensity as well as the symboI for mA will begin to flash up. Important: All stimulation parameters can be changed during the PAUSE mode without emitting stimulation impulses to the patient. Renewed short pressing of the ON/OFF/PAUSE button will end the PAUSE mode, and the normal stimulation mode is resumed. 3.3 Choice of mode The stimulation frequency patterns you require may be activated comfortably by pressing the mode buttons 1 Hz/2 Hz – for VARIO and PLEX 50 Hz/100 Hz · TOF · DBS – for VARIO

14

3.6. Double Burst Stimulation mode (DBS) – only VARIO Pressing the DBS/TOF button is sufficient to activate the Double Burst Stimulation (DBS). After doing so, the MultiStim VARIO will immediately generate a group of stimulating impulses consisting of two short impulse groups. This »double pulse group« (DBS) is continuously repeated every ten seconds. For safety reasons, this function is only available for the 60 mA range, i.e. when a percutaneous stimulation cable is connected to the device. 3.7 Train-Of-Four mode (TOF) – only VARIO To switch into the Train-Of-Four mode, press the DBS/TOF button twice. After doing so, your MultiStim VARIO will generate a group of 4 stimulation impulses with a frequency of 1 Hz. This group of stimulation pulses is repeated continuously in cycles of ten seconds. For safety reasons, this function is only available for the 60 mA range, i.e. when a percutaneous stimulation cable is connected to the device. 3.8. Amplitude selection (Setting of the nominal stimulating current) The stimulation amplitude may be varied by the two buttons “+” and “–”. A short depression of these buttons will alter the amplitude by the smallest possible adjustment step. A continuous change of the adjusted value is achieved by keeping the button depressed. The speed of modification is

XS190055G Multistim_CE0124 12.05.10 09:59 Seite 15

3.9 Display modes for stimulation amplitude Pressing the PRESET/ACTUAL-current intensity button will activate the indication mode for the intensity of the stimulating current. A single click will indicate the actual intensity of the stimulation current flowing through the patient, a double click will indicate the preset intensity of the stimulation current. During the indication of the actually flowing current, a symbol resembling a human being is displayed on the LCD on the right hand side of the current intensity. After activation, the device is in the mode “Indication of the preset stimulation current intensity”. The device remains in the chosen mode until the button is pressed again. If you have adjusted the intensity of the stimulation current to > 0.05 mA during operation, and the indication mode “Indication of the actual intensity of the stimulation current flowing through the patient” shows a stimulation current of 0.0 mA, the following causes may be the reason for the fault: – there is no patient line attached to the device, or it may be faulty – the electrodes are not attached correctly, or they are not attached at all – the electrical resistance of the tissue is too high.

3.10 Indication of the battery condition and volume control The MultiStim offers a battery test function that allows to show the condition of the internal 9 V battery. The battery condition of your MultiStim is indicated as the percentage [%] of the remaining capacity. A battery capacity indication of 100 % (~ 9.2 V) corresponds with a “full” battery, 0 % (~ 7.0 V) corresponds with a battery discharged to a degree at which safe operation is no longer ensured over a longer period of time. At a battery capacity lower than 0 % the BAT. indication will start to flash. Then the battery should be replaced soon, or a substitute battery should be kept at hand. Always turn the MultiStim off for battery replacement. All settings will remain saved for unlimited time, even after the battery has been removed. 3.10.1 VARIO The battery testing function is activated by pressing the BAT./VOL./PULSE button once. 3.10.2. PLEX The battery testing function is activated by pressing the BAT./VOL. button once. 3.11 Volume control The MultiStim devices offer a program option which allows you to control the volume of the monitoring sound. Your display will show a number (0 – 10) appearing next to the VOL. indication. This number corresponds to a certain predefined volume. This volume may be increased or reduced with the help of the “+”- and the “–” button. For visual control of the nominal volume you will consequently receive the corresponding confirmation on the display. 3.11.1 VARIO The volume control function is activated by double click on the BAT./VOL./PULSE button. 3.11.2 PLEX The volume control function is activated by double click on the BAT./VOL. button.

15

GB/US

increased during the whole time period during which the button is depressed. The present nominal stimulating current is shown on the LCD. This nominal value will only correspond to the stimulation current actually emitted, if the electrical stimulation circuit is duly closed over the patient. In this case, the selected stimulation current (set point), which is shown on the display, cor-responds exactly to the stimulation current actually flowing through the electrical circuit of the patient. This correct function is indicated by the “=” symbol. As soon as the stimulation current differs from the selected stimulation current actually flowing, the “≠” symbol will ap-pear on the display. Please note, that in this case the current actually flowing through the patient might be lower than the desired stimulation current which you have previously selected. An increase of the selected stimulation current therefore might not effect the stimulation current actually flowing through the patient. If this happens, it is absolutely necessary to reduce the nominal stimulation current, and to discover the cause of the inadequate or missing patient connections. Do not increase the nominal stimulation current under any circumstances before the reason for the faulty current flowing through the patient has been identified clearly and has been remedied.

XS190055G Multistim_CE0124 12.05.10 09:59 Seite 16

GB/US

3.12 Adjusting the bandwidth of the stimulation impulse – VARIO only A triple click of the BAT./VOL./PULSE button will activate a program option which allows you to adjust the bandwidth of the stimulation impulses. The current intensity value and the mA indication will disappear from the display. The bandwidth of the stimulation impulses shown in the upper right corner of the display can now be increased or decreased with the aid of the “+/–” button in a range of 0.1 ms (= 100 µs) 0.3 ms (= 300 µs) 0.5 ms (= 500 µs) V mA 1.0 ms (= 1000µs). Double Burst Train Of Four 60mA BAT

ms 2nd F

100Hz 2Hz

Two seconds after the last activation of the button, or the pressing of another function key, the control mode is exited and the selected value is stored. Please observe: The stimulation is not interrupted during the adjustment. The bandwidth of the current stimulation impulse changes when exiting the control mode. It is recommended, to adjust the bandwidth of the stimulation impulses before connecting to the patient, or to conduct the adjustment in the PAUSE mode. For security reasons: on account of the high emission of energy, the maximum bandwidth of the stimulation impulses in percutaneous stimulation is limited to 0.5 ms (= 500 µs) in the 50 Hz mode, and to 0.3 ms (= 300 µs) when applying the 100 Hz mode. In addition, you should take into account that battery life is shortened considerably when using large impulse bandwidths. Attention: If you attempt to increase the aforementioned maximum impulse bandwidths when using the 50 Hz/100 Hz mode in percutaneous stimulation, or if you switch to the 50 Hz/ 100 Hz mode from other V stimulation functions which mA use greater impulse bandwidths than the aforementioned maximum impulse bandwidths, “no” will ap-pear on the LCD, since this impulse bandwidth is not available for this stimulation function. In addition, the device emits three acoustic warning signals, and the impulse bandwidth is automatically reduced to the longest possible pulse duration of 0.5 ms at 50 Hz, and 0.3 ms at 100 Hz. Double Burst Train Of Four VOL 60mA BAT 50Hz 1Hz 100Hz 2Hz

ms 2nd F

4 Display elements The LCD of the MultiStim permanently shows the operational settings.

16

Double Burst Train Of Four VOL 60mA BAT 50Hz 1Hz 100Hz 2Hz

ms 2nd F

All display elements of MultiStim VARIO.

V mA

The impulse indication: a pulse symbol at the left rim of the display indicates the emission of pulses. BAT. indication: by the appearance of the BAT. symbol the MultiStim is signaling that the battery charge is too low.

5 Error messages After switching the MultiStim on, the device automatically carries out a self-test. If the self-test recognizes a faulty function, the corre-sponding error code is indicated on the LCD. After that, the device is not operational anymore and may not be used further. The MultiStim has to be sent to the manufacturer for repair. You should indicate the error code in the repair order. The following error codes are possible: E 0 Wrong cable type or defective cable E 1 Program memories faulty E 2 Version changed E 3 Defective iRAM E 4 Switching between the 6 mA and the 60 mA setting is faulty E 5 The switching threshold for equal and dissimilar is not correct E 6 No pulse tension is available, or the pulse tension supply is too low E 7 Faulty device alignment The alignment has changed E 8 The EEPROM (permanent memory) has undergone an uncontrolled change. The manufacturer’s settings and the alignment values are not correct any more E 9 The central processor exhibits faulty functions

6 The battery The proper charge of the battery must be examined regularly. Proceed as described in section 3.10 Indication of battery condition. The present battery capacity will be displayed on the LCD. A battery capacity of less than 0 % will cause the BAT. indication to start flashing, and the battery should be replaced. If the battery capacity drops to a value which will impair the functionality, the device will, one (1) minute after the last activation of a button and while the BAT indication is flashing, emit sequences of acoustic warning signals (sound groups with approx. 5 Hz) for one (1) further minute. If no button is pressed within this minute, the device will switch itself off. If the MultiStim is not used for a longer period of time, the battery should be removed to avoid leakage.

6.1 Battery replacement

Attention: In case of battery leakage, the device should not be operated anymore for security reasons. If acid leaks into the inside of the device, essential functional assemblies may be damaged or impaired. The device must be returned to the manufacturer for inspection.

equipment in accordance with MPG is required to keep a device roster book. b) The following entries are to be made into the device roster book: 1. Date and time of the functionality test before the first operational use of the device. 2. Date and time of the familiarization, as well as the names of the persons familiarized with the operation of the device. 3. Date and time of the execution of the prescribed technical safety checks, and of maintenance measures, as well as the name of the person or the company which has carried out the measures. 4. Date, time, type and consequences of malfunctions and repeated operating errors of the same type. c) A copy of the CE conformity certificate in accordance with MPG is printed in the device roster book and is to be kept.

7 Cleaning and disinfection of the device

9 References to hazards

Only use soft, moistened cloths to clean and disinfect the device and the electrode cables. Water, soapsuds or denaturated alcohol are particularly suitable for this purpose. Take care that no water or humidity enters the device. Alcohol, or commercially available alcohol based disinfectants containing no methyl alcohol may be used for disinfection.

The MultiStim should not be used with patients carrying implanted electrical devices (cardiac pacemakers) without previously having ob-tained corresponding medical advice from a specialist. Possible disturbances of the implanted electrical devices by the stimulating current may constitute a hazard for the patient. The adhesive electrodes may not be attached in the area of injuries. The MultiStim may not be used in the proximity of equipment which produces electromagnetic fields, e.g., HF-surgical apparatus, therapeutical appliances generating short waves and micro waves or wireless telephones. Possible induction of currents with high frequencies on the stimulating electrode may result in damage done to the nerves. The MultiStim may not be used in explosive surroundings. The patient current should not fall below the following values:

The battery compartment is located on the bottom side of the MultiStim. Open the compartment by unscrewing the screw situated on the back side of the device with a suitable tool. Replace the battery. Check for correct polarity. Exclusively use 9 V alkali-manganese batteries (e.g., VARTA 4022, DURACELL MN 1604). With these batteries you will obtain a prolonged duration of functionality, thereby substantially achieving a more reliable operation.

Attention: The following agents may not be employed for cleaning purposes: trichlorethylene, acetone, butanone (methyl ethyl ketone), benzene, methyl alcohol or cellulose thinner (Cellosolve, etc.).

8 Maintenance and technical safety checks Check proper condition of the device and the accessories before use. A faulty device may not be operated. Electromedical pieces of equipment may only be repaired by the manufacturer or an expressly authorized institution. A detailed description of the fault is to be included in the repair order. 8.1 Technical safety checks Technical safety checks are not required, since a failure of the device does not have any endangering consequence to the persons involved. The functioning of the device is to be checked according to the details given in the operating instructions before every application. 8.2 Device roster book in accordance with MPG a) The operator of class IIa technical medical

MultiStim Vario: MultiStim Plex:

0.15 mA in invasive and 0.60 mA in percutaneous application 0.15 mA.

Operate the MultiStim only using genuine PAJUNK accessories displaying the CE label. All accessories must be subjected to a visual inspection at regular intervals. The isolation of the patient lines may not show any damage. In case of battery leakage, the device should not be operated anymore for security reasons. The device must be returned to the manufacturer for proper cleaning. The same procedure is to be followed if water has entered the device! The device may not be operated anymore if the acoustic warning signals (sound groups with approx. 5 Hz) are audible. The device must be returned to the manufacturer for proper repair. 17

GB/US

XS190055G Multistim_CE0124 12.05.10 09:59 Seite 17

XS190055G Multistim_CE0124 12.05.10 09:59 Seite 18

When discarding the MultiStim and the listed accessories, the users must comply with the respective current regulations for the disposal of waste.

GB/US

10 Instruments and accessories The medicine product law (MPG) stipulates that a device may be operated only with accessories and instruments which have been tested and have been declared technically safe. Check proper condition of the device and the accessories before every use, and observe the enclosed instructions for care and disinfection.

11 Accessories and spare parts list for MultiStim The following PAJUNK products may be used as genuine accessories for the MultiStim devices. They are available in a wide variety of measurements: ✚

All stimulation cannulas for one-time/single use nerve blocking anaesthesia. ✚ All stimulation cannulas for continuous nerve blocking anaesthesia. ✚ Stimulating catheters for continuous peripheral nerve blockades.

✚

Patient main cable for the connection of stimulation cannulas and commercially available, CE-labeled adhesive stimulating electrodes to the MultiStim. ✚ Percutaneous patient cable with 2 pushbutton connectors for the connection of commercially available, CE-labeled adhesive stimulating electrodes to the MultiStim. ✚ Various extensions and adapter lines.

12 Signal courses/gradients patterns and power characteristics curve The stimulation is carried out at all signal courses by means of monophase negative square pulses. Electric energy is emitted only for the duration of the stimulation impulse. Therefore, please note, that the measurement and the comparison of the nominal/effective current (indicated by »=« or »≠«) is exclusively carried out during the period of the negative stimulation impulse. This status is saved and displayed during the interpulse period until the next impulse is emitted. This means, that a short-term wrong indication may occur during the 10 seconds break when using DBF and TOF if the current intensity is changed during the interpulse period, which, however, is immediately updated at the next stimulation impulse.

Signal patterns

TWITCH Key:

1 Hz/2 Hz

1.0 secondss = 1 Hz 0.5 seconds = 2 Hz

TETANUS Key:

DOUBLE-BURST Key:

50 Hz: 20 milliseconds 100 Hz: 10 milliseconds

50 Hz/100 Hz*

20 ms

20 ms

TOF*

* VARIO only

Burst 2: 60 ms repeating every 10 s

TRAIN-OF-FOUR

18

repeating every 10 s

750 ms

DBS* Burst 1: 60 ms

Key:

20 ms

500 ms

XS190055G Multistim_CE0124 12.05.10 09:59 Seite 19

Power Curves

7

70

6

60

5

50

4 3 Operation range 2 1 0 0

5

10

15

20

Resistance (kΩ)

13 Limitation of Warranty/Disclaimer PAJUNK® GmbH Medizintechnologie guarantees to manufacture its products with greatest possible care. THIS IS THE ONLY VALID GUARANTEE, AND IT SHALL REPLACE ALL OTHER WARRANTIES GIVEN AND REPRESENTATIONS MADE. It shall be observed, that due to the biological differences of the persons to be treated, no product is always absolutely effective under all environmental conditions and circumstances. Components of the sets manufactured by PAJUNK® GmbH Medizintechnologie, as well as their individual components are compatible with each other. Before the use of individual products/sets of PAJUNK® GmbH Medizintechnologie in connection with products from other companies, the user must ensure the application-specifical compatibility of the individual products. PAJUNK® GmbH Medizintechnologie has no influence on the application of the product, on the diagnosis of the patient and on the handling of the product outside of the company. PAJUNK® GmbH Medizintechnologie can neither guarantee a beneficial nor a complication-free application of the product. PAJUNK® GmbH Medizintechnologie therefore assumes no liability for damages and costs. PAJUNK® GmbH Medizintechnologie will replace products showing a deficiency, which is to be rep-

GB/US

0–60 mA/percutaneous – VARIO only

Stimulation current (mA)

Stimulation current (mA)

0 – 6 mA/invasive

40 30 20 10 Operation range 0 0

5

10

15

20

Resistance (kΩ) resented by PAJUNK® GmbH Medizintechnologie. Employees of PAJUNK® GmbH Medizintechnologie shall not be authorised to amend the aforementioned conditions, to extend liability, or to accept or consent to additional product-related obligations. General Notes In accordance with U.S. law, this product may only be sold by a physician or upon his prescription. All rights to change or modification of the product shall remain reserved. Products are free of latex. Made in Germany – manufactured by PAJUNK® GmbH Medizintechnologie

19

XS190055G Multistim_CE0124 12.05.10 09:59 Seite 48

Storage conditions 65

30°C

GB/US

10°C

20

Symbol for: Keep away from sunlight Keep away from rain Temperature limitation Humidity limitation Consult instructions for use Do not use if package is damaged Do not resterilize Sterilized using ethylene oxide Do not re-use Manufactured and monitored acc. to European Legislation for Medical Devices Manufactured acc. to European Legislation for Medical Devices PHT

Does not contain Phthalates (acc. to sec. 7.5 of Annex I 93/42/EWG)

PHT

Does contain Phthalates as identified Does not contain latex Contains latex Non-pyrogenic Pieces Catalog number, Unique identifier Batch-Identification „Use-by“-date Date of manufacture

48