Zimmer PremoPortFour Instructions For Use Manual Download Page 36 | Manualshive

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Zimmer PremoPortFour Instructions For Use Manual Download Page 36

Legal notice

14

Page 30

14.

Legal notice

The device is not listed in attachment 1 but it is listed in attachment 2 of the
Medical Device Operator Ordinance (MPBetreibV). According to section 14
MPBetreibV, the device must undergo a metrological control (MTK) every two
years. The result must be documented in the medical device book and identified
by a test seal on the device indicating the year during which the next control is
due. 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.

Note:

This information applies to the operation of the unit in Germany. Please
consider divergent national regulations in your country, if applicable.

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Summary of Contents for PremoPortFour

Page 1: ...Instructions for Use PremoPortFour EN ...

Page 2: ...nt 1 LCD display 2 Start Stop button 3 Event button 4 Day Night button Back 5 Identification plate 6 Battery compartment Side 7 Fibre optic cable connection 8 Cuff connection Accessories 9 Fibre optic cable 10 Cuff with bayonet connection 11 USB fibre optic converter 6 7 5 8 9 10 1 2 3 4 11 ...

Page 3: ...56 200 31 1 Blood pressure cuff large 56 200 270 1 Fibre optic cable 2 core 56 200 260 1 USB fibre optic converter 56 200 410 1 Device pouch with shoulder and hip strap 87 921 001 4 Battery 1 2 V type AA 56 310 955 1 Battery charging device Subject to technical changes Optional accessories depending on version and design ...

Page 4: ...t the interface configuration in DiagnostikSuite if necessary Select patient Select the entry Open in the navigation area Double click to select the desired patient Prepare examination In the navigation area open the New tab and for a new ambulatory blood pressure measurement select Prepare measurement Transfer the patient data and the measurement plan to the PremoPort Four Record data Disconnect ...

Page 5: ...s symbol indicates Caution with regard to possible damage of the device 0123 CE mark according to MDD 93 42 EEC Applied part type CF according to EN 60601 1 Note instructions for use Serial number Item number Manufacturer Date of manufacture Start Stop button Event button Day Night button Fibre optics Fibre optic cable connection Cuff Cuff connection ...

Page 6: ...lication information 4 3 Warnings 5 4 General description Range of services Intended use 8 5 Start up Interfaces Power supply 10 6 Operation instructions Displays Buttons Blood pressure cuffs Monitoring rules 13 7 Technical information Technical data Storage and transport 20 8 Cleaning and disinfection 22 9 CE mark 24 10 Scope of delivery accessories 25 11 Device combinations 27 12 Safety and main...

Page 7: ...r 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 Last updated May 2017 We reserve the right to revise this document at any time or change product specifications described herein without any obligation to provide information externally in this regard ...

Page 8: ...ivalent to that performed by a trained and experienced person with a cuff and stethoscope using the auscultatory method according to Korotkoff phase V within the limit defined in the national American standard for electronic and automated sphygmomanometers The algorithm also meets the requirements of the protocol for automated blood pressure monitors of the British Hypertension Society The algorit...

Page 9: ... proven reliable in patients with atrial fibrillation or other common rhythm disturbances the oscillometric blood pressure measurement is generally recommended only with particular caution in patients with rhythm disorders Parkinson s disease or other diseases which are accompanied by tremors 1 2 Side effects Side effects Just as in the case of office blood pressure measurements there can be petec...

Page 10: ...the operation of equipment in the vicinity by electromagnetic effects It may be necessary to take appropriate remedial action such as realignment re arrangement of the device or install electromagnetic shielding Occurrence of discomfort during the recording Inform your patient that any measurement can be immediately interrupted by pressing any button The interruption causes an immediate decrease i...

Page 11: ...man Medical Devices Act and the Medical Device Operator Ordinance apply According to the Medical Device Operator Ordinance medical devices may be set up operated and used only by persons who have the necessary training or knowledge and experience to do so Safety information for setup and installation Prior to putting the device into operation the connection cables should be checked for damage Dama...

Page 12: ...ure monitoring Information about blood pressure measurement Prior to each use of the PremoPort Four the user must ascertain its functional safety and proper operating condition Ensure that air circulation in the cuff and in the tube are not obstructed since this can lead to circulation problems with serious injury to the patient The pressure tube should never be knotted compressed or pulled apart ...

Page 13: ... 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 The optical plastic cable ensures optimal galvanic separation and reduces the effects of external electronic interferences It does not conduct any electricity Hazardous substances Used batterie...

Page 14: ...al dysfunction For monitoring antihypertensive therapy Please also take note of the corresponding medical literature What does PremoPort Four do PremoPort Four achieves excellent measurement quality and is favoured because of its fast and safe handling as well as high reliability What are the other benefits of PremoPort Four Compact dimensions and lightweight for more than 24 hours of wear comfort...

Page 15: ...remoPort 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 16: ... connected to the PC via a fibre optic cable 9 with directly connected USB fibre optic converter 11 The PC must have a free USB connection Caution To guarantee the reliable function of the ambulatory blood pressure system only additional devices and connection cables approved by Zimmer MedizinSysteme may be used 7 9 11 ...

Page 17: ... It is strongly recommended to use newly charged rechargeable batteries or new disposable batteries for each patient so that there is enough battery capacity for the complete monitoring especially in the case of very high blood pressure values and or longer periods of ambulatory measurements After inserting the batteries in PremoPort Four it is advised to check their voltage prior to programming D...

Page 18: ...acity rechargeable batteries or two new long life disposable batteries in the battery compartment in accordance with the indicated polarity and close the battery compartment If you decide to use alkaline batteries select batteries with a high capacity and long life to enable reliable operation A narrow struck through battery symbol on the LCD display indicates a low battery voltage ...

Page 19: ...blood pressure measurement Heart symbol blinking at heart rate Active measurement Systolic value of the measurement which has just ended mmHg Diastolic value of the measurement which has just ended mmHg Pulse rate of the measurement which has just ended beats per minute Blood pressure measurement discontinued by pressing a button Battery voltage display 2 37 V Error display Event marking with butt...

Page 20: ... displayed the recorder returns to normal operation This function helps reduce the chance of inadvertently switching the device off While the recorder is switched off no other functions are available The recorder can only be manually switched on Switch device on PremoPort Four is switched on by pressing the Start Stop button and holding it down for at least 3 seconds If the device is switched off ...

Page 21: ... an event block Day Night button Record going to bed and getting up With the Day Night button the patient records when he she goes to bed and when he she gets up in the morning Discontinuing a blood pressure measurement The patient may discontinue a blood pressure measurement at any time by pressing any button while the cuff is under pressure Immediately after doing so the cuff will be quickly def...

Page 22: ...ouch can be secured to the body with the shoulder strap and hip strap When placing the cuff it is recommended to wear a thin shirt or blouse under the cuff This does not affect the accuracy of the measurement but it prevents possible problems which can occur after the cuff is worn for a long time such as itching sweating Place the cuff on the upper arm such that the plastic tube points upwards The...

Page 23: ...children use the small cuff for adults with a normal arm circumference use the standard cuff regular and for adults with adipose arms use the large cuff Important Please ensure that the cuff is secured tightly but is still comfortable for the patient to wear A cuff which is applied too loosely causes a longer measurement time because the pump first inflates the cuff and only then can the pressure ...

Page 24: ...is worn for a long period of time sweat itching pain etc The cuff must be correctly placed and connected Patients should avoid excessive movements during the blood pressure measurement Opening and closing the hand should be avoided during the measurement as should moving the fingers Patients should keep their arm loose and somewhat away from their upper body When standing Allow arm to hang loosely...

Page 25: ...sive phase The device can be put down for short periods for example when showering To do so the ambulatory blood pressure recorder must be switched off the cuff is slid off the upper arm without opening it After showering the cuff is slid back on It is very important to explain to the patient about the proper positioning of the cuff He she should not forget to switch the ambulatory blood pressure ...

Page 26: ...nal transmission Measurement data memory Internal read only memory Data transmission Optical PC interface Fibre optic adapter with a USB connector Blood pressure measurement Blood pressure measurement method Oscillometric Storage capacity 600 individual measurements Pressure system 0 300 mmHg Blood pressure measurement range 30 260 mmHg Heart rate range 40 200 bpm Pressure sensor Piezo resistive P...

Page 27: ... blood pressure measurement algorithm was validated by the British Hypertension Society and AAMI Environmental conditions Transport and storage 20 C to 50 C 10 to 95 relative humidity without condensation Operating conditions 10 C to 45 C device 10 C to 40 C cuff 10 to 95 relative humidity without condensation 700 hPa to 1060 hPa air pressure Subject to technical changes 7 2 Storage and transport ...

Page 28: ...hower in the bath or in swimming pools Do not expose the recorder to extreme heat or radiation nor to any long periods of direct sunlight Cleaning Housing care Water and soap or commercially available solvent free plastic cleaning agents can be used for cleaning Wipe the surface of the PremoPort Four until the dirt is removed using a soft cloth soaked according to the specifications of the manufac...

Page 29: ...d 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 Note Ensure that no water gets into the tube opening of the cuff during cleaning and disinfection Close the sleeve with a cap or a clip Note The cuff is not suitable for sterilisation in a steriliser Note Do not use ...

Page 30: ...CE mark 9 Page 24 9 CE mark The device has the CE mark 0123 in accordance with the EC directive on medical devices 93 42 EEC ...

Page 31: ...Blood pressure cuff regular 56 200 270 1 Fibre optic cable 2 core Opto fibre optic cable depends on delivery 56 200 260 1 Converter Opto USB for fibre optic cable depends on delivery 56 200 410 1 Device pouch with shoulder and hip strap 87 921 001 4 Battery 1 2 V type AA 56 310 955 1 Battery charging device 1 Instructions for use Subject to technical changes Optional accessories dependent on versi...

Page 32: ...200 021 Blood pressure cuff regular 56 200 031 Blood pressure cuff large 56 200 270 Fibre optic cable 2 core Opto fibre optic cable 56 200 260 Converter Opto USB for fibre optic cable 56 200 410 Device pouch with shoulder and hip strap 87 921 001 Battery 1 2 V type AA 56 310 955 Battery charging device Subject to technical changes Additional accessories for the ambulatory blood pressure measuremen...

Page 33: ...nes 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 Note The installation start up and operation of the connected devices are described in the respective instructions for use ...

Page 34: ...rsons authorised by Zimmer MedizinSysteme Only accessories provided by Zimmer MedizinSysteme GmbH are used The user has ascertained the functional safety the proper operating condition and the mechanical integrity of the device before use The device is operated only by properly trained personnel The device is not operated in hazardous areas and or a combustive atmosphere The device is immediately ...

Page 35: ...the display and blood pressure measurement unit place the blood pressure cuff on the upper arm and connect the cuff to PremoPort Four Briefly push the Start Stop button All segments of the LCD display can be seen for approx 3 seconds Then the pump process begins The increasing numerical values on the display and an increase in pressure in the cuff can be seen After a successful measurement the sys...

Page 36: ... identified by a test seal on the device indicating the year during which the next control is due 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 Note This informa...

Page 37: ... www zimmer de You will help us solve the problem if you have the following information at hand Accurate description of the problem Version number of the DiagnostikSuite Serial number of PremoPort Four Computer configuration Typical sources of error The following causes may be responsible for inaccurate measurements or non evaluable results Use of the device outside of the areas of application des...

Page 38: ...e to discontinue the measurement 03 Batteries dead The batteries died during the measurement The remaining charge was not sufficient to continue the measurement 04 Batteries replaced The batteries were replaced during the ambulatory measurement 09 External interference External electrical interferences or static discharges caused an interruption of the measurement 31 Cuff not connected The cuff wa...

Page 39: ...easurement plan the time on the PC is transmitted to PremoPort Four Wrong cuff type Make sure that the cuff type used is identical to the one set in the measurement plan Leaky or defective cuff Check the cuff and if necessary use a new cuff Air circulation problems Start a manual measurement and check its progression Use Receive and display in DiagnostikSuite together with the measurement values t...

Page 40: ...r the patient data and the measurement plan When the connection is correct a red light briefly blinks at the end of the fibre optic cable Then reconnect the fibre optic cable to PremoPort Four Interface problem of the operating system Check in the Windows device manager whether there is a general problem with the interface If necessary use another interface Check the functionality of the desired i...

Page 41: ...ctory in Neu Ulm Disposable and rechargeable batteries should not be discarded in household waste under any circumstances 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 42: ...turer s declaration Electromagnetic emissions 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 operated in such an environment Interference emission measurements Compliance Electromagnetic environment Guideline HF emissions according to CISPR 11 Group 1 The PremoPort Four de...

Page 43: ... 5 1 kV voltage external conductor external conductor 2 kV voltage external conductor ground Not applicable The quality of the supply voltage should correspond to that of a typical business or hospital environment Voltage dips brief interruptions and fluctuations in the supply voltage according to EN 61000 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 c...

Page 44: ...e cables that is less than the recommended safety distance which is calculated according to the equation applicable to the transmission frequency Recommended safety distance d 3 5 V1 P d 1 17 P for 80 MHz to 800 MHz d 2 33 P for 800 MHz to 2 5 GHz with P as the rated output of the transmitter in watts w according to the information of the manufacturer of the transmitter and d as the recommended sa...

Page 45: ...ironment in which the HF disturbances are controlled The customer or user of the PremoPort Four device can help avoid electromagnetic interference by maintaining a minimum distance between portable and mobile HF telecommunication devices transmitters and the PremoPort Four device depending on the output power of the communication device as indicated below Rated output of the transmitter W Safety d...

Page 46: ...n about blood pressure measurement 6 Insert batteries 12 Installation 5 Interfaces 10 Instruct patient 1 Intended use 9 Interface configuration 1 Interfaces 10 L LCD displays 13 Legal notice 30 M Maintenance 28 Malfunction No blood pressure measurement available 33 No communication 34 Not working correctly 34 Malfunctions and corrections 4 31 Manufacturer s EMC declaration 36 Monitoring rules 18 M...

Page 47: ...echnical information Accuracy 21 Blood pressure measurement 20 Display 20 Disposal 35 Electrical safety 20 Energy supply 20 Environmental conditions 21 Mechanical data 21 Signal transmission 20 Storage and transport 21 Typical sources of error 31 V Views 1 W Warnings 5 ...

Page 48: ...HOe 0517 I Version 2 I Modifications reserved PremoPortFour 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 Instructions for Use ...

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