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Schiller BR-102 PLUS User Manual Download Page 11

 Page 11

A

rt.

 no.

: 2.

511

076 Rev.:

 g

Safety Notes

1

User Guide

Safety Symbols and Pictograms

1.11

BR-102 plus / BR-102 plus PWA

1.11 Safety Symbols and Pictograms

1.11.1

Symbols used in this Document

The safety level is classified according ANSI Z535.4. The following
overview shows the safety symbols and pictograms used in this
manual.

 

1.11.2

Symbols on the Device, Batteries, and Accessories

For general symbols, 

see Appendix - Symbols, page 73

For a direct danger which could lead to severe personal injury or to
death.

For a possibly dangerous situation, which could lead to serious bodily
injury or to death.

For a possibly dangerous situation which could lead to personal injury.
This symbol is also used to indicate possible damage to property.

For general safety notes as listed in this chapter.

Note

 For possibly dangerous situations, which could lead to damages

to property or system failure. 

Important

 or helpful user information.

Reference to other guidelines.

Type BF equipment, safe for external applications.

Symbol for the recognition of electrical and electronic equipment.

Recycle the recorder and batteries separately from other waste.
Equipment/components and accessories no longer required must be
disposed of in a municipally approved collection point or recycling
centre. Alternatively, you can return the equipment to your supplier or
SCHILLER AG for disposal. Improper disposal can harm the
environment and human health.

Summary of Contents for BR-102 PLUS

Page 1: ...User Guide Art no 2 511076 Rev g 2 511076 24 48 Hour Ambulatory Blood Pressure Recorder BR 102 PLUS BR 102 PLUS PWA ...

Page 2: ...rovided on our internet site www schiller ch Sales information can also be obtained from sales schiller ch BR 102 plus BR 102 plus PWA bears the CE 0123 mark Notified Body TÜV SÜD Produkte Ser vice GmbH Ridlerstr 65 80339 Munich Germany indicating its compliance with the essential re quirements of the Annex I of the Medical Device Directive 93 42 EE regarding safety functionality and labelling The...

Page 3: ...WA 14 2 2 The medilog DARWIN2 Program 15 2 3 Inserting Changing the Batteries 15 2 4 Connecting the Pressure Hose and Microphone 16 2 5 Main Components of the Device 17 2 5 1 Operating and Display Elements 18 2 5 2 Switching on 18 2 5 3 Switching Off 19 2 5 4 Battery Status for NiMH Rechargeable Batteries 20 2 5 5 Battery Display for Energizer Ultimate Lithium Battery 21 2 5 6 Time Display 21 2 6 ...

Page 4: ...5 1 3 Cleaning the Device 45 5 1 4 Cleaning the Pressure Hose Microphone Cable Assembly 45 5 2 Cleaning the Cuff and Pouch 46 5 2 1 Cleaning the Cuff 46 5 2 2 Cuff Preparation 47 5 2 3 Cleaning the Pouch as well as the Shoulder and Waist strap 50 5 2 4 Disinfection 51 5 2 5 Admissible Disinfectants for the Casing 52 5 2 6 Non admissible disinfectants 52 5 2 7 Sterilisation 52 6 Maintenance 53 6 1 ...

Page 5: ...lus PWA 8 2 General Accessories 63 8 3 Cuff and Cuff Accessories 64 9 BR 102 plus PWA 65 9 1 Overview 65 9 2 Measurements 65 9 3 Display of Pulse Wave Analysis 65 9 4 Method 66 10 Patient Diary 67 10 1 Patient Diary Example 67 11 Index 71 12 Appendix Symbols 73 ...

Page 6: ...Page 6 Art no 2 511076 Rev g BR 102 plus BR 102 plus PWA ...

Page 7: ...ometric signals or purely oscillometric signals to measure the blood pressure of human beings Systolic diastolic mean arterial pressure and heart rate are measured The BR 102 plus BR 102 plus PWA is intended as an aid to diagnosis and treatment when it is necessary to measure an adult or adolescent patient s blood pressure over an extended period of time up to 24 48 hours Further with each measure...

Page 8: ...nderstood these operating instructions In particular this section safety notes must be read and understood Damaged or missing components must be replaced immediately The operator is responsible for compliance with all applicable accident prevention regulations and safety regulations The safety reliability and performance of the unit can only be guaranteed when the maintenance intervals as stated i...

Page 9: ...recommended by SCHILLER Unsuitable agents can damage the device Clean and disinfect the device in accordance with the instructions given in this book Make sure that the staff have read and understood the operating instructions particularly this Safety Notes section Immediately report any changes that impair safety including operating behaviour to the person responsible Only use accessories and oth...

Page 10: ...ryone who connects additional equipment to the signal input part or signal output part configures a medical system and is therefore responsible that the system complies with the requirements of the valid version of the system standard IEC EN 60601 1 If in doubt consult the technical service department or your local representative The BR 102 plus BR 102 plus PWA is safe during defibrillation Howeve...

Page 11: ...ibly dangerous situation which could lead to personal injury This symbol is also used to indicate possible damage to property For general safety notes as listed in this chapter Note For possibly dangerous situations which could lead to damages to property or system failure Important or helpful user information Reference to other guidelines Type BF equipment safe for external applications Symbol fo...

Page 12: ...ge always remove the batteries from the device when not used for prolonged periods with carrying pouch According DIN VDE 0470 PART 1 EN 60529 IEC 529 Protection against deposits of dust and protection against spray water The first digit indicates the protection of the equipment against ingress of solid foreign bodies and dust and the second digit indicates the degree of protection of the equipment...

Page 13: ...th individual time and interval settings for each program This enables long term blood pressure measurements to be taken at pre set intervals for different patients and conditions Standard BR 102 plus Ambulatory Blood Pressure recorder Standard or BR 102 plus PWA Pulse Wave Analysis Four rechargeable AA NiMH batteries Battery charger unit Cuff size M medium adult and pressure hose with microphone ...

Page 14: ...oys the oscillometric method only Note that with this recorder no microphone is provided with the cuff 2 1 2 BR 102 plus PWA The BR 102 plus PWA Pulse Wave Analysis is identified by the white front casing and takes measurements using the auscultatory Riva Rocci Korotkoff method with oscillometric as back up The setup and settings of the BR 102 plus PWA measurement interval cuff application and sta...

Page 15: ...tery removal ribbon is positioned under the batteries so that the batteries can be removed from the recorder when depleted Ensure that the batteries are inserted with the correct polarity as shown 4 Position the battery cover in the cover slides and slide back in place until it clicks to secure Use NiMH rechargeable batteries supplied or recommended by SCHILLER Full capacity of new NIMH batteries ...

Page 16: ...ery charger part numbers are detailed at the end of this book see Accessories page 63 The hose microphone assembly can only be inserted in one direction Take care when positioning the assembly not to damage any connectors Do not pull directly on the hose or microphone cable Position the pressure hose connector a and attach to the BR 102 plus BR 102 plus PWA by gently pressing until the connector c...

Page 17: ...nnector f Battery recess battery cover removed g Battery removal ribbon h Micro SD card recess under battery removal ribbon i Calibration label j Programming function key k Microphone for recording patient identification l Programming function key and ON OFF key NEW RECORD LAST RECORD SINGLE MEAS SYSTEM NEXT OK 05 16PM SCHILLER BR 102plus c b a l j k d e g f i h The micro SD memory card is for ser...

Page 18: ...isplayed If an unformatted micro SD card is installed you are prompted to format the card when the recorder is switched on and again when a recording is started NEW RECORD LAST RECORD SINGLE MEAS SYSTEM NEXT OK 05 16PM SCHILLER BR 102plus Right Blue Key Functions OK confirm menu selection Change toggle through options Yes confirm selection Meas initiate a measurement during the recording Start Sta...

Page 19: ... recording is running first stop the recording by holding the Green control button for 4 seconds and confirming that the recording will be stopped see Stopping the Recording page 39 Then enter the main menu and switch off as described above Any recorded data is saved when the recorder is switched off SCHILLER 15 12 2013 SCHILLER BR 102plus exit NEW RECORD LAST RECORD SINGLE MEAS SYSTEM NEXT OK 05 ...

Page 20: ...e batteries are not changed during this period a warning message is given that the batteries must be changed If the batteries are still not changed an error message is displayed before the recorder switches off see next page Full 80 Half full Low capacity 20 Empty Battery low Change battery immediately NO YES WARNING Battery low Change battery immediately OK ERROR An audible and visual indication ...

Page 21: ...4 hour or 12 hour display am pm displayed this setting is defined in System setup see DATE TIME page 25 If Energizer Ultimate Lithium batteries are used the battery status display is shown blue and always full This is because the voltage hysteresis curve for these types of battery is not linear and the device cannot accurately determine battery capacity When battery capacity is very limited the ch...

Page 22: ... with the blue key NEW RECORD LAST RECORD SINGLE MEAS SYSTEM NEXT OK 05 16PM RECORD SETUP PROGRAM PATIENT ID START BACK NEXT OK NEW RECORD PatGrp ADULT RecDur 24 hr DefSpd 5 mmHg s DispResult ON BACK NEXT OK RECORD SETUP In all displays the top line is colour coded to give an indication of the type of message that is displayed as follows ERROR WARNING 05 16PM RECORD SETUP Grey Main Menu Light Blue...

Page 23: ...f to prevent patient concern dur ing the recording PROGRAM Defines the program parameters Select program A B C D Select one of four individual recording programs A B C D The programs are defined in Program Setup below PRO GRAM SETUP A B C D Four individual BP measurement pro grams A B C and D can be de fined Each indi vidual program has up to 8 cycles with separate start time BP measure ment inter...

Page 24: ...ng the recording BACK Return to main menu LAST RE CORD RECORD DATA Date and time pa tient group record duration deflation speed number of measurements OK Press OK again to return to the previous menu PATIENT DATA Play voice ID Note If started from a PC the pa tient data is also displayed Stop Stops voice MEASURE MENTS Displays results of stored recording Back Next Press back next to go back to las...

Page 25: ...rrent date in the format defined Time Format 12 24 hour Set time Set current time in the format defined SYSTEM INFO Serial number Hardware and pneumatic index software version control date that the next test MTK is due SD card capacity if inserted SERVICE AREA Service informa tion and check screens Test Calibra tion In this menu option the BP measurement can be checked against a calibrated manomet...

Page 26: ...t medical supervision In some patients petechiae haemorrhages or subcutaneous haematomas may occur All patients must be told when putting on the cuff that if they experience pain during the recording they should switch off the equipment and inform the doctor The cuff must not be attached to a limb that is already used for interventions such as infusions SpO2 measurement loss of data can occur duri...

Page 27: ...signs of ischaemia purpuras and or neuropathy To prevent incorrect measurement results ensure that the tube is not pinched or compressed A cuff that is applied to a patient in the recumbent or sitting position is normally located at the same level as the heart i e middle of the cuff at the level of the right atrium of the heart However if the cuff is located at a level higher than the heart for in...

Page 28: ...e placed on the right arm if required 4 Locate the brachial artery above the elbow bend inside the upper arm 5 Position the microphone marked Micro over the brachial artery and secure cuff Wrap the cuff around the upper arm in such a way that the patient can still bend arm the bottom edge of the cuff should be 2 cm away from the elbow bend Tighten the cuff and secure with the velcro strip The cuff...

Page 29: ...cure the tubing to the body if required 9 When the cuff and device are comfortably positioned the patient can replace upper clothing The oscillometric version does not contain a microphone however the cuff is placed in the same manner It is recommended that the patient wears a t shirt over the tubing to help hold the tubing in place This can be covered with for example a loose fitting shirt To hel...

Page 30: ...ize Midpoint arm circumference cm Cuff designation 18 26 S Small adult Child 25 35 M Adult 35 45 L Large adult Note A cuff that is too small for the patient may give over measurements Similarly a cuff that is too large for the patient may give under measurements To fit arm size Midpoint Arm Circumference cm Cuff Designation 14 20 XS Child Osc only 18 24 S Small Adult Child 25 35 M Adult 30 36 L La...

Page 31: ...e Hose and Removing the Microphone and Bladder page 47 2 Remove the foam rubber microphone insert from the adhesive pad and place the microphone in the pad metallic patient side outwards and press to secure with the adhesive 3 Using an alcohol solution standard surgical strength thoroughly clean the patient s arm around the brachial artery area 4 Wrap the cuff around the uncovered upper arm in suc...

Page 32: ...trength thoroughly clean the patient s upper arm in the area where the pad will be at tached 2 Remove the plastic adhesive protector of the velcro securing pad 3 Place the pad on the patient s upper arm and apply gentle pressure to secure the exact location will depend on the size of the patients arm and the size of the cuff used 4 Position the cuff so that the velcro securing flap on the cuff mat...

Page 33: ...nformation Date and time of the measurement Recording method used KOR Auscultatoric Korotkoff Riva Rocci OSC Oscillometric Measurement SYS Systolic Pressure mmHg DIA Diastolic Pressure mmHg MAP Mean Arterial Pressure MAP in mmHg Pulse Pulse rate bpm beats per minute NEW RECORD LAST RECORD SINGLE MEAS SYSTEM NEXT OK 05 16PM SCHILLER Right Blue Key Left Green Key When auto setting is defined the def...

Page 34: ...asurement intervals can be defined A long term recording can also be started and the recording times defined from the medilogDARWIN2 program See the user guide for details NEW RECORD LAST RECORD SINGLE MEAS SYSTEM NEXT OK 05 16PM SCHILLER Right Blue Key Left Green Key NEW RECORD LAST RECORD SINGLE MEAS SYSTEM NEXT OK 05 16PM NEXT CHANGE PROGRAM SETUP Program B A 06 30 15 B 08 00 20 C 09 00 10 D 22...

Page 35: ...mes sleep times and duration for the four programs Highlight the recording program to be set and set the start time and measurement duration for each entry Up to 8 separate start times can be defined with the BP measurement interval defined for each start time 1 Define the start time by pressing change The time counts up in 10 minute intervals 2 When the desired start time is shown press next The ...

Page 36: ...2 program Select Start Recording and speak the patient data into the de vice Speak clearly into the microphone Hold the unit approximately 15 20 cm distant To ensure recording clarity do not hold the unit too far away Select Stop Recording when the Patient ID has been stated The recording time allowed for Patient ID is up to 30 seconds 7 Select Start c to start the recording You are prompted to co...

Page 37: ...lus page 39 Initial Measurement Check After the first measurement on the resting patient it is recommended that the following is checked to help ensure that the recording is successful Ensure that a BP reading has been obtained and is displayed on the BR 102 plus BR 102 plus PWA Check that the measurement has been taken using the auscultatory method KOR displayed next to the measurement below the ...

Page 38: ... xx Changing batteries when following audible and mes sages are displayed The batteries must be changed when an audible indication is given and the message Battery LOW change battery is displayed Proceed as follows 1 Confirm Change battery with the blue button 2 Remove the batteries and replace with the fully charged batteries supplied Observe correct polarity see Inserting Changing the Batteries ...

Page 39: ...d giving Date and time Measurement method KOR Auscultatoric Korotkoff Riva Rocci OSC Oscillometric Systolic Pressure in mmHg Diastolic Pressure in mmHg Mean Arterial Pressure MAP in mmHg Pulse rate PULS in beats minute bpm 4 Next continues to the following measurement and Back returns to the previous measurement 5 To return to the main menu press Back for approximately 4 seconds The recorder also ...

Page 40: ...ogDARWIN2 The recording can be reviewed analysed and a report created with the medilogDARWIN2 program Details of uploading a BP recording to the medilogDARWIN2 program is described in the medilogDARWIN2 user guide Connect BR 102 plus BR 102 plus PWA to PC Use medilogDARWIN2 to retrieve data analyse and edit Print report or save as PDF file ...

Page 41: ...ap nor the air tube ever become wrapped around the neck The air tube must be positioned under a T shirt or outer clothing that must continue to be worn at night over the tubing to help keep it secure Tell the patient that if any numbness in the arm chafing pain or discomfort is experienced the cuff must be removed and to contact the surgery Tell the patient not to get the unit wet the unit is not ...

Page 42: ...here possible the patient relaxes during the meas urement process and does not speak Entries must be made in the patient diary during the long term measurement The pressure tube and cuff must not be kinked stretched or sub jected to compression or restriction The air tube may kink when in flated Explain to the patient that particularly when sleeping the equipment needs be positioned in such a way ...

Page 43: ...astic bag to help prevent a short circuit of the battery The patient should return the spent batteries in the same container If the patient is old or in any way confused consider asking the patient to return to the surgery for battery replacement 4 5 BR 102 plus PWA Unit Measurements The BP measure interval cuff application and the start and stop procedure are identical to the standard unit Howeve...

Page 44: ... and send it to SCHILLER for testing Never use a wet or dripping cloth and never spray the equipment with detergent Otherwise the detergent may seep under the edges of the keyboard or penetrate the device and destroy the electronics Use of cleaning solutions which have a high acid content or are oth erwise inappropriate can cause damage to the equipment including cracking and deterioration of the ...

Page 45: ...ution Do not let the cleaning solution run into or accumulate in connector openings latches or crevices If liquid gets into connectors dry the area with warm air and then check the equipment to confirm that it operates properly 5 1 4 Cleaning the Pressure Hose Microphone Cable As sembly 1 Before cleaning inspect the hose cable for damage Gently bend and flex all parts of the assembly Inspect for s...

Page 46: ...aning bag Dry Clean Prepare the cuff in the same way as for washing Disinfection Disinfect by gently wiping the cuff with an approved hospital grade disinfectant see Sterilisation page 52 Do not use bleach Do not iron Do not tumble dry Do not spin dry Observe the following when washing Program setting of 40 C 104 F Select gentle or delicate cycle Use a mild washing powder Do not use biological pow...

Page 47: ...e microphone and the bladder must be removed from the cuff and the pressure hose disconnected 1 Disconnect the pressure hose from the cuff inflation bladder con nector by twisting the connector a quarter turn 2 Gently remove the microphone from the microphone pouch by pushing on the outside of the cuff to move the microphone along the pouch channel until it can be removed from the cuff 3 Remove th...

Page 48: ...s when inserting in the cuff the metallic side faces the pa tient Ensure that the microphone is correctly inserted in the cuff It must fully reach the bottom of the pouch 2 Replace the bladder in the cuff ensure that the bladder is flat and not twisted in the cuff 3 Connect and secure the pressure hose to the cuff bladder connector with a quarter turn For cuffs with D ring only When re inserting t...

Page 49: ...der hose and connector Gently push the microphone out of the cuff and disconnect the pressure hose from the bladder connector quarter twist After washing re insert the bladder in the cuff Reconnect the pressure hose to the cuff bladder Remove the bladder from the cuff Push the microphone until home in the micro pouch ...

Page 50: ... washing machine at 30 C using a mild washing powder do not spin Do not use fabric softeners or other aids e g disinfectant rinses These solutions may leave residues and damage the material The Pouch is not suitable for drying in a tumble dryer Do not use bleach Do not iron Do not tumble dry Do not expose neoprene pouch to direct sun light Wash the pouch at a temperature of 30 C with a normal wash...

Page 51: ...isinfecting the cuff wipe with a damp cloth SCHILLER has tested and recommends the following solutions Terralin Liquid manufacturer Schuelke Mayr Promanum N manufacturer B Braun Additionally the cuff can be disinfected with the following Cidex Sporicidin Mikrozid Isopropyl alcohol 70 Ethanol 70 Buraton fluid It is vital to observe the manufacturer s instructions for the use of these products Alway...

Page 52: ... detergent Abrasive cleaning agents 100 alcohol Virex Sani Master Sani Cloth Ascepti or Clorox wipes HB Quat Conventional cleaner e g Fantastic Tilex etc Conductive solution Solutions or products containing the following ingredients Ketone for ex acetone Ammonium chloride Betadine Chlorine wax or wax compound Sodium salt 5 2 7 Sterilisation The cuff can be sterilised with Ethylene oxide gas Prepar...

Page 53: ...he cuff and velcro fastening All maintenance work must be carried out by a qualified technician authorised by SCHILLER AG Only maintenance procedures given in this book may be carried out by the user The following table indicates the maintenance intervals the maintenance requirement and the person authorised to carry out the procedure Interval Maintenance Responsible Every 6 months Visual inspecti...

Page 54: ...lly charged see battery charger operating instructions 6 2 2 Battery Disposal Full capacity of new NIMH batteries are only reached after three charge discharge cycles Totally discharged batteries require approximately three hours to be fully charged with two batteries in charger or six hours with four batteries in charger Charged batteries lose their charge when removed from the charg er unit Ther...

Page 55: ...t must be returned to a SCHILLER approved centre for calibration at the interval defined by local regulations or at least every two years A reminder message is displayed 30 days before calibration is due and counts down the subsequent days every time the unit is switched on The message is displayed for approximately 60 seconds before the main BR 102 plus BR 102 plus PWA menu is displayed Select OK...

Page 56: ... BR 102 plus BR 102 plus PWA against the calibrated pressure gauge The two measurements should be within 3 mmHg After 120 seconds the BR 102 plus BR 102 plus PWA releases the pressure The setup shown is an example connection only Dependent on the type of manometer and hose connector used the cuff connector can be removed from the BR 102 plus BR 102 plus PWA and connected directly to the manometer ...

Page 57: ...dly deflates at 320 mmHg 10 mmHg Paediatric 1 Set the record setup to Child This can be done for single meas urement or new record 2 Setup and enter the calibration screen as detailed on the previous page 3 Pump to 200 mmHg Slowly continue to pump and check that the overpressure valve activates a pressure hiss is heard and the cuff rapidly deflates at 225 mmHg 5 mmHg NEW RECORD LAST RECORD SINGLE ...

Page 58: ...t cuff is completely decompressed before commencing a measurement 123 No cuff No pressure 3 mmHg 10 sec after inflation leak in the cuff or hose Connect cuff check hose connections 124 Measur break Measurement stopped manu ally 126 Measurement time Measurement time too long hose cuff or pump is defec tive Check hose connections Check hose and bladder for defects Contact service department 127 Cuff...

Page 59: ... few pulse beats detected OSC Repeat measurement check cuff 210 No pulse No pulse detected KOR Connect microphone Check position of microphone Ensure that the microphone is correctly orientated metallic yellow side towards arm 211 Pulse max Too many pulse beats detect ed KOR Perform measurement in quiet environment avoid moving the arm during measurement 212 Pulse min Too few pulse beats detected ...

Page 60: ...f voice recording Additionally Storage micro SD card Interfaces USB 2 0 interface for data transfer Programming Menu guidance 2 buttons Recording Protocols Four programmable interval groups each group has 8 measurements Measurements Methods of measurement Measurement duration Measuring range Blood pressure Heart rate Deflation rate Measurement intervals BR 102plus Auscultatory Korotkoff Riva Rocci...

Page 61: ...BR 102 plus BR 102 plus PWA is clinically validated to all internationally recognised organisations BHS in progress ESH 2002 AAMI SP10 2002 Environmental conditions Operation Operating temperature Relative humidity Pressure during operation 0 C to 40 C 32 F to 104 F 15 to 95 non condensing 540 hPa to 1060 hPa Environmental Conditions storage and transport Transport temperature Storage temperature ...

Page 62: ...er fre quency MHz Testing fre quency MHz Max Power P W Distanced m Various radio services TETRA 400 380 390 385 1 8 0 3 Walkie talkies FRS Rescue service police fire brigade servicing GMRS 430 470 450 2 0 3 LTE band 13 17 704 707 710 745 780 0 2 0 3 GSM800 900 LTE band 5 Radio telephone microcellular CT1 CT2 CT3 800 960 810 870 930 2 0 3 GSM1800 1900 DECT radio telephone LTE Band 1 3 4 25 UMTS 170...

Page 63: ... 2 511045 medilogDARWIN2 User Guide FR 2 511064 medilogDARWIN2 User Guide ES 2 511065 medilogDARWIN2 User Guide SV 2 511066 medilogDARWIN2 User Guide RU 2 511067 medilogDARWIN2 User Guide ZH S 2 540045 BR 102 plus BR 102 plus PWA Recurrent test and service handbook Part Number Description 2 156077 Premium reusable pouch red BR 102 plus BR 102 plus PWA 2 156079 Premium accessories case red includin...

Page 64: ...plus for oscillometric measurement only 2 120064 BP velcro cuff 2014 size S BR 102 plus BP 200 plus 2 120065 BP velcro cuff 2014 size M BR 102 plus BP 200 plus 2 120066 BP velcro cuff 2014 size L BR 102 plus BP 200 plus 2 120067 BP velcro cuff 2014 size XL BR 102 plus BP 200 plus 2 120068 Comfort fleece size XS package of 10 for BP cuff 2 120063 2 120069 Comfort fleece size S package of 10 for BP ...

Page 65: ...opagating wave that is subsequently reflected from the peripheral site The time point at which these forward and backward propagating waves merge and the amplitude of the reflected backward wave affect the level of central BP 9 2 Measurements After every BP measurement the cuff is again inflated to the diastolic pressure and held for 10 seconds while PWA data is obtained see BR 102 plus PWA Unit M...

Page 66: ...een analysed in a representative cross section of the population see reference 2 and an age dependent estimate for the Alx 75 plus the respective confidence interval have been assessed These relevant analyses have also shown that there is a significant difference for the average Alx 75 between men and women 30 40 50 60 70 20 10 0 10 20 30 40 50 60 20 Age Alx 75 Male mean 90 CI 90 CI 30 40 50 60 70...

Page 67: ...lse Pressure Amplification and Arterial Stiffness American Journal of Hyperten sion 2002 15 24 30 2 Fantin F et al Is augmentation index a good measure of vascular stiffness in the elderly Age and Ageing 2007 36 43 48 3 The Task Force for the Management of Arterial Hypertension of the European Society of Hypertension ESH and the European Society of Cardiology ESC 2007 Guidelines for the management...

Page 68: ...taken If an invalid measurement is made a second measurement will be initiated immediately The unit must continue to be worn during the night time period Wear a T shirt or continue to wear normal outer clothing over the tubing at night to help keep it secure If you have a PWA monitor a second phase is initiated after every measurement the cuff is again re inflated and remains inflated for approxim...

Page 69: ...larity 3 Press the green button to switch the unit on The following message is displayed BP recording Next meas xx xx 4 Make an entry in the patient diary Do not dispose of the old batteries return to the surgery Cuff placement The cuff should be placed on the left upper arm approximately 2cm above the elbow so that the forearm can move Position the MICRO symbol if present on the inside of the arm...

Page 70: ...SCHILLER BR 102 plus BR 102 PWA Patient Diary Time Event Comment Time Event Comment Time Event Comment Time Event Comment Time Event Comment Time Event Comment ...

Page 71: ...rement during the recording 43 L Lithium Batteries 21 Long Term Recording 34 M Main Components 17 Maintenance 44 Medilog Darwin2 Program 15 Menu Structure 22 O Operating and Display Elements 18 P Patient Diary 65 Patient Information 41 Pressure Hose and Microphone Connection 16 Pulse Wave Analysis 65 R RECORD SETUP 35 Recording 26 S Safety Notes 7 Safety Symbols 11 13 SD memory card 17 Settings 25...

Page 72: ......

Page 73: ...ticle number Identification of the manufacturer Identification of the manufacturing date Identification of the distributor Identification of the importer Medical device Serial number Reference number Batch code Global Trade Item Number Catalogue number Quantity UDI unique device identification as QR code machine readable and human readable as number e g Number of pieces in the packaging Authorised...

Page 74: ...deral law USA restricts this device to sale by or on the order of a physician Non ionising electromagnetic radiation To indicate that the device contains a Radio Frequency RF transmitter to transmit data e g Bluetooth or WiFi Contains a Bluetooth module Do not reuse Latex free Use by date expiry date of battery electrodes or other consuma bles Temperature range for storage or transport respectivel...

Page 75: ...rom sunlight protect from direct sunlight Fragile handle with care Transport upwards this way up Do not use hooks EIP electronic information product dos not contain any toxic and hazardous substances or elements above the maximum concentra tion values product can be recycled and re used ...

Page 76: ...1010 Beograd Phone 381 11 39 79 508 Fax 381 11 39 79 518 info schiller rs www schiller rs Slovenia SCHILLER d o o 2310 Slovenska Bistrica Phone 386 2 843 00 56 Fax 386 2 843 00 57 info schiller si www schiller si Spain SCHILLER ESPAÑA S A ES 28232 Las Rozas Madrid Phone 34 91 713 01 76 Fax 34 91 355 79 33 schiller schiller es www schiller es Switzerland SCHILLER Reomed AG CH 8912 Obfelden Phone 41...

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