ri-vital Operating Manual Rev O

Table of Contents Important Information to Consider before Operating Proper Use Warnings and Precautions Overview of Functions Operating Controls Power Supply Basic Settings Pulsoximetry Blood Pressure Measurement Instructions for Care Body Temperature Technical Specifications Scope of Delivery / Accessories Technical Measurement Check Manufacturer's Data regarding EMC EMS Standards

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21 21 21 23 26 27 27 28 28 30 31 31 32 33 34 36

Important Information to Consider before Operating You have purchased a high-quality RIESTER product, which was manufactured in accordance with Directive 93/42 EWG and is continuously subject to strict quality control. Please read this manual carefully before operating the device keep it in a safe place. We will be glad to assist you should you have any questions. You will find our address in this manual. We will provide you the address of our partner upon request. Please note that all of the devices described in this manual are intended solely for use by appropriately trained personnel. Please also note that correct and safe functioning of this device is only guaranteed when used with the original Riester accessories.

Proper Use ri-vital® is a medical device for measuring arterial blood pressure by means of the oscillometric method and arterial oxygen saturation. The pulsoximeter was calibrated to display the functional oxygen saturation, which is determined from the length of the pulse wave using two, highly precise light-emitting diodes (LEDs). The device is suitable for measurements in adults, children and infants. It can be used to measure and display the described values in hospitals, clinics, doctor's offices and similar facilities. Other use is not intended.

Warnings and Precautions Explanation: WARNING: Indicates things that could harm the patient or user. CAUTION: Indicates things that could damage the device. COMMENT:Indicates other important information.

WARNINGS: • • • •

•

• •

Do not use this device together with flammable anaesthetic. Do not use this device in environments where there is danger of explosion. Do not use this device in the vicinity of magnetic resonance imaging (MR) scanners. MR scanners can generate currents that lead to burns. This device's readings must be linked to clinical symptoms and signs. The device is only intended as a tool for diagnosis. If your affix certain sensors with plaster or adhesive tape, do not apply it too tightly in order not to interrupt the patient's blood circulation at the measurement site. If you connect this device to another device, check that this combination if functioning correctly and ensure that no danger is posed to the patient or the user by this combination. Each person who creates such a combination is configuring a medical system and is therefore responsible for complying with the provisions of Standard 60601-1-1. SpO2 sensor that were incorrectly placed can yield incorrect readings. Please heed the operating manual of the sensors. Using defective sensors can result in incorrect displays, which could harm the patient in the worst case scenario. Therefore, you should not use defective sensors. 21

Using sensors with damaged cables can also yield incorrect readings.You should therefore check each cable before use. • This device can display incorrect readings when near strong electromagnetic fields. These fields are generated by high-frequency surgical equipment or mobile phones, for example. • This device can display incorrect readings when near computer tomography (CT) scanners. • Only use this device with the included accessories and with Riester cuffs and sensors. • To ensure precise and safe blood pressure measurement, a cuff of suitable size must be used. The cuff's marking must be within the markers after it has been placed. • Do not apply any pressure on the tube or the cuff while taking the measurement. This could result in incorrect measurements or to the measurement being aborted. • Reading errors can occur during blood pressure measurement in patients who suffer from moderate to severe cardiac arrhythmias. • If continued blood pressure measurements are to be taken from the same patient, then the cuff must be removed between the measurements in order to check the skin underneath the cuff for possible ischemia, discolouration and/or neuropathy. • Only use this device together with the included GlobTek GTM 41060-2512 line adapter. • To prevent measurement errors, the patient must remain still while the measurement is being taken.

Caution: •

• • • •

The device and the sensor should be cleaned with a soft, clean cloth. Please use ethyl alcohol or isopropyl alcohol for deep cleaning. Other agents, in particular substances that contain acetone, will damage the housing or the display. Do not press down on the buttons using hard or sharp objects. Only Riester accessories may be used to operate the device. A function tester cannot be used to test the measuring accuracy of the pulsoximeter or its sensors. This device is only intended for use by medically trained personnel in accordance with this manual.

Comments: •

• •

If the blood pressure cuff is not at heart level, a hydrostatic error of about 0.75 mmHg per centimetre will be produced. If the cuff is lower than heart level, about 0.75 mmHg per centimetre must be subtracted from the displayed value. If the cuff is higher than heart level, about 0.75 mmHg per centimetre must be added. Should this device need to be repaired, please contact Riester directly or contact the dealer from whom you purchased the device. The device sticker can display the following symbols:

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!

Heed the operating manual 0124

CE mark Do not use in the presence of flammable anaesthetic Patient connector, type BF, defibrillation-proof

SN

Serial number Used electrical and electronic devices should not be thrown away with the regular trash but rather should be disposed of separately in accordance with national and/or EU guidelines. Safety class II device No alarm function

Overview of Functions Introduction ri-vital® allows you to measure the oxygen saturation of arterial blood and permits non-invasive measuring of a patient's blood pressure. The illuminated LC display shows the functional oxygen saturation (SpO2) of the arterial blood, the pulse and the mean (MAP), systolic (SYS) and diastolic (DIA) levels of the arterial blood pressure. The sensor used for the SpO2 measurement can be inserted into the front of the device for safekeeping. The device has a carrying handle which simultaneously serves as a storage place for the blood pressure cuffs. The device can be optionally equipped with a holder for the ri-thermo® N thermometer. Pulse Signal A detected pulse beat is indicated with an acoustic signal at the moment of systole; the signal's pitch changes with the value of the oxygen saturation. This allows you to acoustically track the pulse rate and the course of the oxygen saturation without continuously having to keep an eye of the device's display. The pulse signal can be deactivated by pressing the <<Mode>> button.

Built-in Li-Ion Battery The device's battery permits mobile, battery-supplied operation. The frequency of the blood pressure measurements affects the operating time without a power connection. With blood pressure measurements taken at 10-minute intervals, the ri-vital® will work up to 40 hours in battery-operated mode. A symbol on the display indicates the battery's remaining charge. Connect the device to a power outlet with the included mains adaptor to charge it. It takes about 8 hours to recharge a fully empty battery.You can operate the device without problem while it is charging. No memory effect occurs due to the use of Li-ion technology. 23

Device Front

A Carrying handle B Coiler for sensor cable C Sensor holder D LC display with illumination E On/Off button F Charge indicator G Operating buttons H Thermometer holder (optional)

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Left side view

Right side view

I J K L

SpO2 sensor connector Mains adapter connector NIBP cuff tube connector NIBP cuff storage place

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Operating Controls

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16

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SpO2 indicator Pulse indicator Pulse bar indicator Systolic blood pressure Diastolic blood pressure Mean arterial blood pressure (MAP) Current cuff pressure as a bar graph Pulsoximeter information Battery charge status NIBP error message Active NIBP mode (adult or neonate) On/Off button NIBP measurement start/stop Charge indicator (is turned off when the battery is fully charged) Turn pulse signal on/off Switch NIBP mode (adult or neonate)

Power Supply The device can be operated through mains operation or off line with the built-in Li-ion battery. For mains operation, the mains adapter must be connected to a power outlet and be inserted into the left side of the device (J) using the cable. Then the battery is also charged. The yellow charge indicator (F) on the front of the device is illuminated while the device is being charged. If it is not illuminated, the battery is fully charged. For the measurement, the device must additionally be turned on on the front of the device using button (E). As long as the On button is pressed, all segments of the display are activated. Thanks to this, segments that have failed can be clearly identified. If no SpO2 measurement is taken and no blood pressure measurement is started either, then the LCD illumination turns itself off in about 10 minutes. After another 5 minutes, the entire devices turns itself off. This prevents accidental depletion of the battery. In battery operation, the device shows the remaining charge with a symbol (9) in the lower part of the display. This display has a large tolerance because various parameters, such as environmental temperature, also affect the battery.

Basic Settings The settings described below are continuously saved, even if the device is not used for a longer period of time. The settings are done in a special mode. If button (16) is also pressed when turning the device on, then you are taken to the named menu. The following presettings are possible here: The inflation pressure of the device is set by pressing button (13). Then current inflation pressure is shown on the display. Independent of this setting, the device will automatically inflate more if necessary. The pulse signal can be turned on and off by pressing button (15). The current setting can be seed on the signal display (8): the pulse signal is activated when the "Signal" symbol is visible. Press button (16) to switch the operating mode of the blood pressure measurement between adult and neonate mode. The current setting is displayed at (11). The "NEO" setting may only be used for neonates and infants wtube arm measures less than 13 cm in circumference. The pulse signal and the mode setting of the blood pressure setting can also be set later with the corresponding buttons while the device is being used. The permanent presetting is only used for lighter operation in certain surroundings, e.g. the inflation pressure for patients who are hypertonic can be set higher from the outset.

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Pulsoximetry Sensor Connector The sensor connector (I) is located on the left side of the device. The sensor is recessed to prevent damaging the sensor cable, so that the device housing protects the connector. It is recommended that you leave the sensor on the device and use the coiler (B) and the sensor holder (C) for storage. In order to correctly apply the SpO2 sensor to the patient, please read the corresponding operating manual for this accessory part. SpO2 Measurement After the sensor has been affixed to the patient, the segments of the bar indicator (3) will start to pulsate. After a short time the readings (1) (2) will appear on the display. The readings are updated once per second. The message "Signal" will appear in the status display (8) if the sensor or patient is not connected. "Perf" will be displayed if the device detects weak perfusion. Should it then still be possible to take a measurement, readings will continue to be displayed. Please note: no alarm function Pulse Signal When the pulse signal is activated, a brief acoustic signal is emitted for each detected pulse. The pitch depends on the saturation. This signal can also be turned off using the corresponding button (15). Please note: no alarm function Pulse Display If the patient is connected to the pulsoximeter, the pulse reading that is obtained in this manner is always indicated. If no SpO2 measurement takes place, then after a successful blood pressure measurement the device shows the oscillometrically determined pulse. Optionally, the ri-vital® can be ordered with Pearl pulsoxymeter technology (a process for pulse amplification and artefact suppression).

Blood Pressure Measurement Placing the Cuff Slide the cuff over the left upper arm so that the tube is pointing in the direction of the forearm. Make sure that the underside of the cuff is situated about 2 to 3 cm higher than the elbow and the rubber tube is sticking our from the cuff on the inside of the arm. The marking must be directly over the artery that runs on the inside of the arm. Blood Pressure Measurement After turning on the device, press button (13) to start the blood pressure measurement. The device will inflate and determine the systolic, diastolic and mean arterial blood pressure with the next discharge. If necessary, the device will automatically inflate more to be able to measure higher pressures as well. 28

Please note: Pay attention to the NIBP mode (11) setting. Please note: no alarm function Should you need to cancel the measurement, then pressing button (13) once more will result in immediate cancellation of the measurement. Measurement Reading After a successful measurement, the three blood pressures are shown on the display. If no pulsoximetric measurement is taken, then the device also shows the pulse determined during the blood pressure measurement. Any errors are documented with an error number in the field of the systolic reading. Please see Appendix B for the meaning of the error numbers. Instructions for Taking Correct Blood Pressure Measurements Arterial blood pressure is a vital parameter that changes exceptionally fast as soon as there is the slightest physical exertion. Therefore, please heed the following instructions for determining a correct and reproducible result. Avoid eating, smoking as well as any exertion immediately before the measurement. All these factors affect the measurement result. The patient should relax in a calm atmosphere for 5 minutes before the blood pressure measurement. If the patient is wearing clothing that is tight against his/her upper arm, this item of clothing should be removed. Every attempt of the patient to support his/her arm can increase the blood pressure. You should therefore ensure the patient has a relaxed posture. Cuffs that are too narrow or too short yield incorrect readings. Selecting the right cuff is exceptionally important. The cuff size depends on the circumference of the upper arm (measured in the middle). The permissible range is printed on the cuff. A loose cuff or an air chamber that protrudes from the side yields incorrect readings. There may be no gap between the arm and the cuff because otherwise the measurement result will be affected. Items of clothing that have been raised upwards on the arm may not constrict the arm. Otherwise, these items of clothing (e.g., a pullover) must be removed. Make sure that the cuff is at heart level. Also ensure that none of the tube connections are kinked. The patient should not speak during the measurement.

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Blood Pressure Measurement Error Messages E06

E09

E10

E11

E12

E14

Inflation time too long. Causes: No cuff is connected. The cuff is too loose on the arm. The cuff is not tight. Solution: Place the cuff again and start a new measurement. Incorrect cuff Causes: Adult cuff in neonate mode. Neonate cuff in adult mode. Solution: Use the correct cuff. Arrhythmia Causes: The device determined implausible readings during the last measurement. Solution: Take another measurement. Artefact Cause: The device has detected too many motion artefacts. Solution: Take another measurement. Excessive pressure in the cuff or measurement time too long Cause: Pressure was applied on the cuff during the measurement. Solution: Do not touch the cuff and tube during the measurement. Leak in the cuff or in the connector cable Cause: The device recorded an unexpected decrease in pressure during the measurement. Solution: Use a different cuff and check the cable to the device.

Comment: Errors E10 and E11 cannot always be clearly classified; for some arrhythmias an E11 may be displayed. Instructions for Care Device: The device and the sensor should be cleaned with a soft, clean cloth.. Please use ethyl alcohol or isopropyl alcohol for deep cleaning. Other agents, in particular substances that contain acetone, will damage the housing or the display. Cuffs Cleaning: After removing the pad, the nylon Velcro covers can be wiped with a moist cloth or, just like all other cuffs, be washed with soap and cold water. Should you opt for the latter, rinse the cuff with clean water and air dry it. Wipe the pad and the tube with a moist cloth. Disinfection: After removing the pad, the cuff covers can be washed with a disinfectant in cold water and then air dried. The pad and tube can be wiped with a bit of ethanol and a cotton cloth. ATTENTION! Nylon Velcro cuffs may not be ironed! Never subject the cuffs to intense solar radiation! 30

Do not touch the cuff cover nor the pad with a pointy object as this could cause damage!

Body Temperature Measurement The device can be optionally equipped with a holder for the ri-thermo® N thermometer. This holder enables easy storage of the thermometer and provides the required protective cover for the measuring head. For more information about using the device and important instructions regarding measuring precision, please refer to the operating manual for the ri-thermo® N.

Technical Specifications General Mains operation: Mains adapter: Capacity: Protection class: Moisture proofing: Patient module: Battery: Operating time: Charging: Display: Temperatures: Humidity: Mechanical stability: Dimensions:

Weight: Housing:

220/230 V, 50 Hz, through mains adapter 12V, 4 W max. II IPX1 BF for SpO2 Li-ion battery, 7.4 Volt 450 mAh about 500 measurements About 8 hours High-contrast LCD with illumination Storage: -5 to 60° C Operation: 10 to 40 ° C 0...95 % relative humidity, non-condensing Vibration test pursuant to EN ISO 9919:2005 Drop test pursuant to EN ISO 9919:2005 246 mm x 167 mm x 232 mm with handle + ri-thermo® N 203 mm x 167 mm x 232 mm with handle (L x W x H) 1.650g with ri-thermo® N 1.500g without ri-thermo® N Break-proof, easy-to-clean PC + ABS plastic

Note for clinicians: Information regarding the range of the top wavelengths and maximum optical capacity of the light emitted by the pulsoximeter can be useful to clinicians who are applying photodynamic therapy. Pulsoximeter Sensors: Measurement range: Wavelength for the measurement:

All PEARL sensors SpO2 0 - 100 % Pulse 30 - 249 1/min 660 nm/880 nm 31

Intensity: Tolerances:

Display:

Calibration: Blood pressure (NIBP) Cuffs: Measurement range:

Measurement range for neonates:

Measurement precision: Leakage: Overpressure limit: Overpressure limit (2nd level): Time per measurement:

3.8 mW maximum SpO2 +/- 2 % for 70 - 100 % (below this unspecified) Pulse +/- 1% or +/- 1 position Oxygen saturation (Updating of the readings once per second), pulse as well as a bar graph for pulsation (display is not proportional to the strength of the pulse wave.) Functional saturation

All cuffs from the Riester portfolio Systole 25 - 280 mmHg Diastole 10 - 200 mmHg MAP 15 - 260 mmHg Systole Diastole MAP

20 - 155 mmHg 5 - 110 mmHg 10 - 130 mmHg

Mean value difference < +/-5mmHg Standard deviation < 8mmHg < 3 mmHg / minute 300 mmHg in "Adult" mode 150 mmHg in "Neo" mode (neonates) 330 mmHg in "Adult" mode 165 mmHg in "Neo" mode (neonates) approx. 25s on average "Adult" mode max. 170 s "Neo" mode max. 80s

Scope of delivery / accessories Scope of delivery ri-vital® Mains adapter Fingerclip sensor Blood pressure connector tube Blood pressure cuff, size depending on order number Operating manual Accessories Finger sensor adults Finger sensor children Sleeve sensor neonates Velcro cuff neonates Velcro cuff infants 32

(article number 12661) patient weight > 20 Kg (article number 12662) patient weight > 20 Kg (article number 12663) patient weight > 1 Kg (article number LF134) (article number LF132)

Velcro cuff children Velcro cuff adults, thin arms Velcro cuff adults Velcro cuff adults, large arms

(article number LF129) (article number LF120) (article number LF107) (article number LF122)

Mobile stand with basket

(article number 12660)

ri-thermo® N Package with 100 disposable probe covers Package with 1000 disposable probe covers

(article number 12704) (article number 12705)

Technical Measurement Check Germany: Pursuant to the Ordinance on Operating Medical Devices (Medizinprodukte-Betreiberverordung, MPBetreibV), a technical check must be conducted in two-year intervals. The check can only be conducted by the manufacturer, the appropriate authorities or persons who comply with the requirements of MPBetreibV §6. European Union outside of Germany: The respective legal provisions apply for all EU countries outside of Germany. 1. Procedure for Checking Compliance with the Error Threshold of the Reading Display of the Cuff Pressure 1.1 Test equipment a) Solid metal container with a capacity of 500 ml +/- 5%. b) Calibrated control manometer with a maximum permissible error of measurement of 1.0 mmHg (0.1 kPa). c) Pressure generator, e.g. pump ball with discharge valve. d) T pieces and tubes. 1.2 Procedure a) Replace the device's cuff with the metal container (see 1.1a). Connect the calibrated control manometer (see 1.1b) with the cuff connector (see Fig. 1) by means of a T piece and tube (see 1.1d) with the cuff connector (see Fig. 1). Connect the additional pump ball (see 1.1c) to the pneumatic system with the help of another T piece. In order to get to the calibration mode, turn the device off and press the E, F and G buttons simultaneously until "100" appears on the display; when you let go of the buttons, "E01" will be displayed and the device will be in calibration mode. b) Conduct the test in pressure ranges of at most 50 mmHg between 0 mmHg and the highest value of the display range. Exceeding of the overpressure can take place at any desired level. The test can be continued after decreasing the overpressure to the desired value.

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1. Control manometer (see 1.1b) 2. Blood pressure device to be tested 3. Metal container (see 1.1a) 4. Pump ball with discharge valve (see 1.1c) Fig. 1: Test equipment to determine the error thresholds of the reading display of the cuff pressure

Manufacturer's Data regarding EMC Electromagnetic emissions: The device is suitable for use in the electromagnetic environment indicated below. The user must ensure that the device is used in such an environment. Test

Result/Complied with

Comment

HF emission

Group 1

The device must radiate electromagnetic energy in order to fulfil its function. The functioning of surrounding devices can be affected by this. IEC 61000-4-2

HF emission

Class B

The device is suitable for use in all facilities. IEC 61000-4-4

Harmonic emissions

Yes

IEC 61000-3-2

Flicker emission

Yes

IEC 61000-3-3

Voltage fluctuations

Yes

IEC 61000-3-3

Electromagnetic stability (immunity): The device is suitable for use in the electromagnetic environment indicated below. The user must ensure that the device is used in such an environment. Test

Test step

Classification

Comment

Electrostatic discharge

+/-8 kV air +/-6 kV contact

+/-8 kV air +/-6 kV contact

The floor should be made of a non-conductive material. The relative humidity should be at least 30%. IEC 61000-4-2

Voltage peaks

+/-2 kV mains +/-1 kV input output

+/-2 kV mains +/-1 kV input output

The mains power should correspond to the power in a typical business environment. IEC 61000-4-4

Current surge

+/- 1kV difference +/- 2kV common mode IEC 61000-4-5

+/-1kV difference The mains power should correspond to the power in a typical hos+/- 2kV common pital or business environment. mode

Voltage drops

<5% Un(> 95% drop in Ut)

See test step

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The mains power should correspond to the power in a typical hospital environment. If uninterrupted operation must absolutely be guaranteed, then an uninterrupted power supply must be used.

Test

Test step

Classification

Comment

Voltage drops

40% Un (60% drop in Ut) with five full changes

See test step

The mains power should correspond to the power in a typical hospital environment. If uninterrupted operation must absolutely be guaranteed, then an uninterrupted power supply must be used.

Voltage drops

70% Un (30% drop in Ut) with 25 full changes

See test step

Voltage drops

<5% Un (60% drop in Ut) in five second

See test step

Power frequency 50/60 Hz

3A/m

3A/m

The mains power should correspond to the power in a typical hospital environment. If uninterrupted operation must absolutely be guaranteed, then an uninterrupted power supply must be used. The mains power should correspond to the power in a typical hospital environment. If uninterrupted operation must absolutely be guaranteed, then an uninterrupted power supply must be used. IEC 61000-4-11

In the event of operating problems, the device must be placed at a greater distance to the source of the magnetic fields. IEC 61000-4-8

Note: Un is the mains voltage for the test device. Electromagnetic stability (immunity), portable RF devices The distance between mobile communication devices and all parts of the device including all cables should not fall below the distance calculated with the corresponding equation for the frequency of the communication device. Test

IEC 60601-1-2

Class

Distance

Emitted energy

3V/m

3V/m

Distance = 1.2*square root(power) for 80.. 800 MHz

3V/m

3V/m

Distance = 2.3*square root(power) for 800 MHz to 2.5 GHz. IEC 61000-4-3

3 VRMS

3 VRMS

Distance = 1.2*square root(power) for 150kHz to 80MHz. IEC 61000-4-6

Grid-bound energy

The field strengths of stationary senders, such as base stations for cellular phones, of land mobile radio, amateur radio, AM and FM radio transmissions and TV broadcasts cannot be predicted. A site survey should be conducted for assessing the electromagnetic environment of stationary RF transmitters. If the sender's measured field strength at the device's usage site exceeds the above-mentioned values, then the device's function should be monitored. If monitoring shows that the device is not functioning properly, corresponding measures must be taken. For example, the device must be realigned or placed at a different location. Recommended distances The following minimum distances are recommended between the device and portable HF communication equipment (e.g., mobile phones): HF frequency

26Mhz - 80MHz

80MHz - 800 MHz

800MHz - 2.5 GHz

Equation d=1.2*square root(P) Nominal power (w) Distance (m)

d=1.2*square root(P) d=2.3*square root(P) Distance (m) Distance (m)

0.1 1 10 50

0.40 1.20 3.80 8.50

0.40 1.20 3.80 8.50

0.80 1.20 7.30 16.30

P is the nominal power of the transmitter in watts, d is the distance in metres. Example At a transmission frequency of 700 MHz and power of 10 watts, a distance of d = 1.2*root(10) = 3.79 m is recommended.

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EMS standards: Harmonic emissions

IEC 61000-3-2

Flicker emissions

IEC 61000-3-3

Immunity from table electrostatic devices discharge

IEC 61000-4-2, level 3,

IEC 61000-4-3 at 3V/m Immunity from electromagnetic fields caused by high-frequency radiation Immunity from sudden voltage peaks / surges

IEC 61000-4-5, level 3

Current surge immunity

IEC 61000-4-5, level 3

Electromagnetic compatibility caused by conduction

IEC 61000-4-6 at 3V/m

Power frequency magnetic fields

IEC 61000-4-8 at 3 V/m

Operation during mains voltage fluctuations

IEC 61000-4-11, table 7

Warning: Using accessories other than ttube specified can lead to increased emissions and/or decreased stability of the device. This device complies with the following standards, among others: EN1060-1:1995 Non-invasive sphygmomanometers - Part 1: General requirements appendix EN 1060-1:1995/A1:2002 EN1060-3:1997 Non-invasive sphygmomanometers - Part 3: Supplemental requirements for electromechanical sphygmomanometers EN1060-4:2004 Non-invasive sphygmomanometers - Part 4: Test procedures to determine the overall system accuracy of automated non-invasive sphygmomanometers

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Serving the Health C a r e I n d u s t r y T F E W

1800 67 5432 1800 67 5433 enquiries@ec o m e d . c o m . a u ecomed.com.a u

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