Zimmer PremoPortFour Instructions For Use Manual
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Zimmer PremoPortFour Instructions For Use Manual

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Instructions for Use
PremoPortFour
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Summary of Contents for Zimmer PremoPortFour

  • Page 1 Instructions for Use PremoPortFour...
  • Page 2 Figure Views / Operating elements Views Front Back with accessories Operating elements Front Back LCD display Identification plate Start/Stop button Battery compartment Event button Day/Night button Side Accessories Fibre optic cable connection Fibre optic cable Cuff connection Cuff with bayonet connection USB fibre optic converter...
  • Page 3 Schematic illustration Accessories Accessories* Image Art. no. * Number Description 56,200,21 Blood pressure cuff, regular 56,200,31 Blood pressure cuff, large Fibre optic cable 2-core, 56,200,270** 56,200,260** USB fibre optic converter Device pouch with shoulder and hip 56,200,410 strap 87,921,001 Battery 1.2 V type AA 56,310,955** Battery charging device (*Subject to technical changes)
  • Page 4 Brief start-up instructions Brief start-up instructions Hold down the Start/Stop button for at least 5 sec. The device is switched on Switch on PremoPort when the time appears on the LCD display. (e.g. 13:21) Four Hold down the Start/Stop button for at least 5 sec. but less than 10 sec. While Check voltage the button is held down, the voltage is displayed (e.g.
  • Page 5 Symbols Explanation of symbols In the instructions for use this symbol indicates “Danger”. Observe the warnings. In the instructions for use this symbol indicates “Caution” with regard to Caution possible damage of the device. CE mark according to MDD (93/42/EEC) 0123 Applied part type CF according to EN 60601-1 Note instructions for use...

  • Page 6: Table Of Contents

    Table of contents Page PremoPort Four Figure (Views / Operating elements / Accessories) Brief start-up instructions Symbols Background medical information Indications / Contraindications / Side effects Application information Warnings General description Range of services / Intended use Start-up Interfaces / Power supply Operation instructions Displays / Buttons / Blood pressure cuffs / Monitoring rules Technical information...
  • Page 7 Table of contents Functional test Legal notice Error messages, troubleshooting, disposal Manufacturer's EMC declaration Index Valid for PremoPort Four. These instructions for use are an integral part of the device. They must be stored with the device and kept accessible at all times for anyone authorised to operate this device.

  • Page 8: Background Medical Information Indications / Contraindications / Side Effects

    Background medical information Indications / Contraindications / Side effects Background medical information Ambulatory blood pressure measurement (ABPM) over a 24-hour period is an Clinical preconditions important instrument nowadays for the diagnosis and treatment of hypertension. As a result of the relatively high measurement density of about 70 measurements over 24 hours, the reliability of the evaluation of the true blood pressure level increases significantly in comparison to individual measurements.
  • Page 9 Background medical information Indications / Contraindications / Side effects Uncooperative patients, unconscious patients or patients with other Contraindications limitations. Patients who require urgent or emergency cardiac treatment. Patients with coagulation disorders (for ambulatory blood pressure monitoring). Patients with severe impairment of mobility or other functions without monitoring.

  • Page 10: Application Information

    Inspect the device before use. If there is any damage, it must not be used. Caution Only accessories provided by Zimmer MedizinSysteme GmbH may be used. Caution Operation of this device in the vicinity of strong electromagnetic fields (e.g.

  • Page 11: Warnings

    Warnings Warnings Users of the device must be trained in how to use the system properly and have the appropriate skills. Use in wet areas is not permitted and may in case of non-compliance lead to considerable damage and endanger both the patient and the user. Dispose of the packaging material properly.
  • Page 12 Zimmer MedizinSysteme may be used. The use of components which are not included in the scope of delivery or not approved by Zimmer MedizinSysteme for PremoPort Four may lead to measurement errors and malfunctions. The device should never be connected to a PC or other devices while it is Hazards to persons still placed on the patient.
  • Page 13 Zimmer MedizinSysteme recommends a safety distance of at least 2 meters between the patient and PC while PremoPort Four is connected to the PC. PremoPort Four communicates with an optical plastic cable whose 4 m standard length allows the required safety distance.

  • Page 14: General Description

    General description Range of services General description Range of services PremoPort Four, in combination with the DiagnostikSuite analysis software, is What is PremoPort Four an ambulatory blood pressure measuring system (ambulatory blood pressure) used for? for long-term monitoring of patients. The PremoPort Four blood pressure monitor oscillometrically measures blood pressure in adjustable time intervals, saves the values determined and, after the measurement is completed, transfers them for further evaluation to the PC.
  • Page 15 General description Intended use Intended use PremoPort Four, in combination with the DiagnostikSuite analysis software, is an ambulatory blood pressure measuring system for long-term monitoring of patients. PremoPort Four should not be used for monitoring vital signs. Not suitable for infants and small children. Page 9...

  • Page 16: Start-Up

    USB fibre optic converter (11). The PC must have a free USB fibre optic converter connection. To guarantee the reliable function of the ambulatory blood pressure system, Caution only additional devices and connection cables approved by Zimmer MedizinSysteme may be used. Page 10...
  • Page 17 Start-up Power supply Power supply PremoPort Four blood pressure monitor works with two 1.5 V AA disposable General batteries or two 1.2 V AA rechargeable batteries. Use only commercially available, long-life (alkaline) batteries or standard NiCd or NiMH rechargeable batteries in the correct size. Do not use lithium batteries. Do not mix different types of batteries and do not mix old and new batteries under any circumstances.
  • Page 18 Start-up Power supply Take the PremoPort Four out of the pouch and remove the battery Insert batteries compartment lid on the back of the device. Insert two charged high-capacity rechargeable batteries or two new long-life disposable batteries in the battery compartment in accordance with the indicated polarity and close the battery compartment.

  • Page 19: Operation Instructions

    Operation instructions Displays Operation instructions Displays The device has an integrated LCD display (1) on which the measurement LCD display results and various information is displayed. The most important information is listed below. Two lines indicate that LCD test: All seg the recorder is ments are shown switched off...
  • Page 20 Operation instructions Buttons Buttons The Start/Stop button is located nearest the LCD display and combines these Start/Stop button functions: Manual blood pressure measurement If it appears necessary, the patient can start an additional manual blood - pressure measurement by briefly pressing the Start/Stop button. The result is marked as a manual measurement and is saved in the device.
  • Page 21 Operation instructions Buttons Event button Mark an event By briefly pushing the Event button, the patient can mark any event without a blood pressure measurement being necessary. Typical reasons for this are: Waking up, going to bed, taking medications, feelings of dizziness, palpitations, pain, athletic activities.
  • Page 22 Operation instructions Blood pressure cuffs Blood pressure cuffs PremoPort Four detects and supports three different cuff sizes: Cuff sizes Type Bladder size Cuff size circumference* Regular adult 12.5 x 22.5 cm 15 x 52 cm 24 – 32 cm Small adult (child) 6 x 28.5 cm 9 x 41 cm <...
  • Page 23 Operation instructions Blood pressure cuffs The cuff must be positioned such that the pressure tube is not kinked Important anywhere. The tube connection to the cuff should therefore be aimed upward. The pressure tube should be positioned so as to ensure free movement of the upper arm.
  • Page 24 Operation instructions Monitoring rules Monitoring rules The recorder is programmed by the DiagnostikSuite installed on the PC. After the pre-programmed start time has been reached, the recorder will automatically begin the measurement program and perform the blood pressure measurements based on the measurement plan. To obtain reliable blood pressure values, certain rules must be observed.
  • Page 25 Operation instructions Monitoring rules Patients can start manual additional blood pressure measurements with the Start/Stop button on the PremoPort Four. They should use the Event button to mark special events such as the administration of medication. Waking up or going to sleep are saved using the “DAY/NIGHT” button. They can interrupt any individual measurement, as needed, by pressing any button.

  • Page 26: Technical Information

    Technical information Technical data / Storage and transport Technical information Technical data Power supply 2 x 1.5 V AA alkaline batteries or Energy supply 2 x 1.2 V AA NiCd or NiMH rechargeable batteries. Measurement cycles with fully 250 – 300 individual measurements in 24 to charged high-capacity 48 hours rechargeable batteries...
  • Page 27 Technical information Technical data / Storage and transport Dimensions 105 x 73 x 37 mm Mechanical data Width x height x depth Weight 248 g including batteries 200 g without batteries Static accuracy ± 3 mmHg or ± 2% of the measured value Accuracy (Stability: 2 years) Accuracy of the blood pressure...

  • Page 28: Cleaning And Disinfection

    If liquid penetrated the device, remove the rechargeable/disposable batteries from the device and contact Zimmer customer service. Do not expose the device to heavy rain or water vapour and do not bring it into a wet environment, such as under a shower, in the bath or in swimming pools.
  • Page 29 Clean the cuff with a damp cloth, having been previously moistened with a mild Cuff soap solution or a suitable disinfectant fliud (e.g. ethanol 70%, isopropyl alcohol 70%, mikrozid sensitiv). For disinfection Zimmer MedizinSysteme recommends applying mikrozid sensitiv. Note: Please note that the bladder cannot be removed from the cuff. Bladder and cuff are one part.

  • Page 30: Ce Mark

    CE mark CE mark The device has the CE mark 0123 in accordance with the EC directive on medical devices 93/42/EEC. Page 24...

  • Page 31: Scope Of Delivery, Accessories

    Scope of delivery, accessories Scope of delivery 10. Scope of delivery, accessories 10.1 Scope of delivery Scope of delivery Art. no. * Number Description Blood pressure monitor PremoPort Four 56,200,021 Blood pressure cuff, regular 56,200,270** Fibre optic cable 2-core, Opto fibre optic cable (depends on delivery) 56,200,260** Converter, Opto / USB, for fibre optic cable...
  • Page 32 Scope of delivery, accessories Accessories 10.2 Accessories To ensure reliable function of the ambulatory blood pressure system, only original accessories from Zimmer MedizinSysteme may be used. List of accessories Art. no. * Description 56,200,021 Blood pressure cuff, regular 56,200,031 Blood pressure cuff, large...

  • Page 33: Device Combinations

    Device combinations 11. Device combinations PremoPort Four can be combined with the DiagnostikSuite evaluation software. Anyone who combines devices and thus creates a medical system does so under his/her own responsibility. When combining devices, observe the specifications of standard DIN EN 60601-1. In doing so, please note the information in chapter 3 “Warnings”.

  • Page 34: Safety And Maintenance

    Safety and maintenance Safety / Maintenance 12. Safety and maintenance 12.1 Safety As the manufacturer, Zimmer MedizinSysteme can only consider itself to be responsible for safety and reliability if PremoPort Four is only operated in accordance with the instructions for use.

  • Page 35: Functional Test

    Disconnect the examination device(s) and remove the disposable or rechargeable batteries. Note: In the event of malfunction or visible damage, do not use the ambulatory blood pressure measurement system. Contact the service department of Zimmer MedizinSysteme. Page 29...

  • Page 36: Legal Notice

    The metrological control may only be performed by an approved testing facility. Contact Zimmer MedizinSysteme in this regard. In Germany, the regulation regarding electrical systems and equipment (German Social Accident Insurance (DGUV) Regulation 3), as amended, must additionally be observed.

  • Page 37: Error Messages, Troubleshooting, Disposal

    Telephone +49 731 / 9761 - 115 +49 731 / 9761 - 4443 You can also receive support via email: support@zimmer.de Visit us online at: http://www.zimmer.de You will help us solve the problem if you have the following information at...
  • Page 38 Error messages, troubleshooting, disposal Error messages / Troubleshooting The PremoPort Four has various error codes which quickly provide information Error codes about the cause of the error. The error is displayed on the device, saved, and transferred with the measurement data to DiagnostikSuite. Error - Description Possible cause...
  • Page 39 Error messages, troubleshooting, disposal Error messages / Troubleshooting Malfunction Possible cause Remedy Wrong time set Check time on the display of No blood pressure PremoPort Four and the PC. Correct measurements available time on PC. (When transferring the measurement plan, the time on the PC is transmitted to PremoPort Four).
  • Page 40 Error messages, troubleshooting, disposal Error messages / Troubleshooting Malfunction Possible cause Remedy PremoPort Four is not switched Switch on PremoPort Four PremoPort Four is not communicating with the PC, no “PC” display during data transfer Fibre optic cable is not correctly Check whether the connection cable connected on the PC and PremoPort Four is...
  • Page 41 NiCd batteries are to be considered hazardous waste in any case. Disposable and rechargeable batteries are to be disposed of in accordance with the German Battery Act. Note In foreign (European) countries, disposal is handled by dealers authorised by Zimmer MedizinSysteme. Page 35...

  • Page 42: Manufacturer's Emc Declaration

    Manufacturer's EMC declaration 16. Manufacturer's EMC declaration Medical electrical devices, such as PremoPort Four, are subject to special precautionary measures with regard to EMC (electromagnetic compatibility) and must be installed and put into operation according to the EMC information in the instructions for use or accompanying documentation.
  • Page 43 Manufacturer's EMC declaration Guidelines and manufacturer's declaration – Electromagnetic immunity The PremoPort Four device is intended to be operated in an electromagnetic - environment as indicated below. The customer or user of the PremoPort Four should ensure that it is used in such an environment. Immunity tests IEC 60601- test Compliance...
  • Page 44 Manufacturer's EMC declaration Guidelines and manufacturer's declaration – Electromagnetic immunity The PremoPort Four device is intended to be operated in an electromagnetic environment as indicated below. The customer or user of the PremoPort Four should ensure that it is used in such an environment. Immunity tests IEC 60601- Compliance...
  • Page 45 Manufacturer's EMC declaration The field strength of stationary transmitters, such as base stations for radio telephones and land mobile radios, amateur radio stations, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment with regard to the stationary transmitters, an electromagnetic site survey is to be recommended.

  • Page 46: Index

    Index 17. Index Installation .............. 5 Interfaces ............10 Accessories ............26 Instruct patient ............1 Air circulation ............6 Intended use ............9 Interface configuration ..........1 Interfaces .............. 10 Background ............4 Background medical information ......4 Blood pressure cuffs ..........16 LCD displays ............
  • Page 47 Index Start/Stop button........... 14 Mechanical data ..........21 Switch on PremoPort Four ........1 Signal transmission .......... 20 Storage and transport ........21 Typical sources of error ........31 Technical information Accuracy ............21 Blood pressure measurement ......20 Views ..............1 Display ..............
  • Page 48 PremoPortFour Instructions for Use Zimmer MedizinSysteme GmbH Junkersstraße 9 89231 Neu-Ulm, Germany Tel. 07 31. 97 61-291 Fax 07 31. 97 61-299 export@zimmer.de www.zimmer.de...

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