The instructions for use must be read carefully before use. The product may only be used in accordance with the intended purpose. The manufacturer accepts no liability or warranty for damages caused by improper use or failure to observe the instructions for use. The product may only be used if the sterile packaging is intact prior to first opening. The product must be transported and stored in a dry place. The following temperatures must be maintained in order to avoid influencing the product properties: ■ Storage temperature: Room temperature ■ Ambient temperature for application: Room temperature...

Technical data The stated values reflect nominal values and may differ. 1 probe 3PN 1 butterfly suture clamp 1 instruction manual Double packed EO sterilised For single use only HDM29.1 ICP monitor with battery (230 V and 115 V) The ICP probe should only be positioned by a neurosurgeon. Further handling can be done by persons, who have completed medical training and have experience in dealing with neurological trauma (intensive care nurses). The products are intended exclusively for use in professional healthcare facilities. The ICP probe is used for parenchymal measurement of intracranial pressure...

Contraindications The ICP probe must not be used for purposes other than those specified. Components that have come into contact with infected tissue should not be used further. Use is always contraindicated in cases of scalp infections, patients receiving anticoagulant therapy and increased bleeding tendency. It is also contraindicated when continuous monitoring by trained personnel cannot be guaranteed. Warnings Possible complications when using the ICP probe include dislocation, bleeding and infection. Care and caution should be exercised when handling the ICP probe. Do not pull on or jerk...

MRI safety information Non-clinical testing has shown that the “Intracranial Pressure and Catheter System” is “MR conditional”. A patient with this product can be safely scanned in an MRI system meeting the following conditions: • static magnetic field of 1.5 - 3 Tesla with • maximum spatial field gradient of 2,300 G/cm (23 T/m) • maximum force product of 38,000,000 G2/cm (38 T2/m) • theoretically estimated whole body averaged (WBA) specific absorption rate (SAR) < 2 W/kg (Normal Operating Mode). Under the scanning conditions defined above, the “Intracranial Pressure and Catheter System” is expected...

• Make sure that all components of the EVD set used with the ICP probe are "MR Safe” or "MR Conditional” at 1.5 or 3 Tesla. • Spiegelberg ICP monitors must never be brought into rooms marked as MRI environments. The ICP probe should be checked for completeness prior to use. NOTE! If the printed depth markings (2) are not clearly legible, another ICP probe must be used. NOTE! The appropriate insertion site and technique must be selected by the surgeon. 1. Perform aseptic preparation of the surgical area and put up surgical drapes. 3. Place the drill hole (minimum diameter: 2.6 mm). Clean the drill...

10 NOTE! The resulting loop should be covered with a bandage to prevent it from becoming caught on the tube and the ICP probe being pulled out. Connection to the ICP monitor WARNING! The HDM connector (4) must not be disinfected or moistened, otherwise the filter inside the connector will clog. WARNING! The HDM connector (4) must be kept dry. Otherwise the ICP probe may lose function or the ICP monitor may be damaged. NOTE! If any liquid gets into the HDM connector (4), do not connect it to the ICP monitor. 1. Connect the HDM connector (4) on the ICP probe to the probe connector on the ICP monitor....

NOTE! The ICP probe must not be pulled over sharp or uneven edges during removal to avoid damaging the tube and possibly tearing the ICP probe. 1. Disconnect the ICP probe from the ICP monitor. 2. Loosen the fixings attaching the ICP probe to the patient. 4. Check that the ICP probe has been removed completely and that the tissue has not been damaged. 5. Observe the condition of the patient. NOTE! No components of the ICP probe (e.g. the air chamber, 1) may be left in the patient. After use, the product should be disposed of in accordance with the regulations for infectious waste and/or in accordance...

Spiegelberg GmbH & Co. KG Tempowerkring 4 21079 Hamburg Germany E-mail: [email protected] http://www.spiegelberg.de Subject to technical changes. Version: 13 / 2022-06-29