ri-vital Operating Manual Rev C Oct 2017

WARNINGS: • Not suitable for use near flammable anaesthetic gas mixtures of air, oxygen or nitrous oxide. • 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. • The device‘s readings must be linked with 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 is functioning correctly and ensure that no danger is posed to the patient or the user by this combination. Anyone who combines devices configures a medical system and is therefore responsible for complying with the provisions standard 60601-1-1. • Incorrectly placed SpO2 sensors can yield incorrect readings. Please heed the operating manual of the sensors. • The use of defective sensors can lead to incorrect displays that could harm the patient in the worst case. Therefore, you should not use defective sensors. • 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. • The 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.

ri-vital WARNINGS

47

• Always ensure that the cuff hose is not bent, as this can lead to an impairment of circulation due to the continuous cuff pressure on the limbs, which could lead to serious injury to the patient. Always ensure that the cuff is not applied over a wound as this can lead to further damage to the patient. Always ensure that the cuff is not applied to any limb where intravascular access or intravascular therapy or an arteriovenous (AV) shunt is present, as a temporary interruption of the blood flow can lead to injury and damage to the patient. Always make sure the cuff is not placed on the same side where breast amputation has taken place. Ensure that the cuff is not applied to the same limb when another ME device is already connected for monitoring. This could lead to malfunctions of the ME devices. • 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 operate this device with the GlobTek mains adapter of type GTM21089- 1512-T3, as supplied.

• If continued SpO2 measurements are to be taken from the same patient, then the measurement position must be changed regularly. Please check the measuring position against skin irritations, sufficient perfusion and correct position of the sensor. Please change the position of the sensor at least every 4 hours. • To avoid measurement errors, the patient must remain still while the measurement is being taken. • This predictive thermometer must NOT be used without a newly placed probe covers from Riester. • Only use original Riester probe covers with this device. The use of other probe covers leads to erroneous temperature readings • The predictive thermometer and the probe covers are NON-STERILE. Do not use on grazed tissue.

ri-vital WARNINGS AND PRECAOUTIONS

48

• In order to avoid cross-contamination, only use BLUE thermometer probes to measure ORAL or AXILLARY temperature.

• Only use RED thermometer probes for measuring RECTAL temperature. • Do not open ri-vital and/or the predictive thermometer. The device does not contain any parts that can be maintained by customers. Opening the device can impair the calibration and will invalidate the warranty.

• Disposal of used probe covers must comply with current medical practices and the local regulations concerning disposal in medical facilities.

• Further information on disposal of the lithium batteries is available in the respective community or from the environmental advisory board responsible.

• Used electrical and electronic devices should not be disposed of with normal household waste, but should be disposed of separately according to national or EU guidelines.

• This device is only intended for use by trained medical persons.

CAUTION: • The device and the finger sensor should be cleaned with a soft, clean cloth. Please use white spirit or isopropyl alcohol to remove heavy soiling. Other agents, especially acetone-based substances, damage the housing or the display.

• Do not press the key with hard or sharp objects. • Only accessories intended by Riester may be used to operate the device. • A function tester cannot be used to test the measurement accuracy of the pulse oximeter or its sensors.

ri-vital WARNINGS AND PRECAOUTIONS

49

REMARKS: • 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. • If a repair to this device is necessary, please contact Riester directly or the dealer from whom you purchased the device. • We accept back devices that have been delivered by us and will dispose of them in a environmentally friendly manner. Please send the device to our company address (carriage paid by receiver). • The device sticker can display the following symbols:

0124

CEmark Do not use in the presence of flammable anaesthetic Patient connection type BF Serial number Used electrical and electronic devices should not be disposed of with normal household waste, but should be disposed of separately according to national or EU guidelines. Device of protection class II No alarm function Date of manufacture Oral or axillar measuring point Rectal measuring point

ri-vital WARNINGS AND PRECAOUTIONS

50

Observe the Operating Manual Sensor not connected to the patient (displayed in the SpO2 window) Sensor not connected to the device (displayed in the SpO2 window) Attach probe cover Not sterile Latex free Single use DEHP free

OVERVIEW OF FUNCTIONS 4.1 Introduction ri-vital allows you to measure the patient‘s oxygen saturation of arterial blood and non-invasive measuring of blood pressure, as well as optional measurement of oral, axillary and rectal body temperature. The TFT colour display shows the functional oxygen saturation (SpO2) of the arterial blood, the pulse, the mean (MAP), systolic (SYS) and diastolic (DIA) levels of the arterial blood pressure, as well as the temperature of the selected region of the body. The sensor used for the SpO2 measurement can be inserted into the front of the device for safekeeping. The optional predictive thermometer is equipped with a removable/replaceable insertion device for the thermometer probe, as well as a storage compartment for the probe cover box. 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 ear thermometer.

ri-vital OVERVIEW OF FUNCTIONS

51

4.2 Information about body temperature It is a common misconception that 37 °C is the „normal body temperature“. It is actually the case that 37 °C is the average body temperature. The normal body temperature is in a range that varies with age, gender and measuring point. Furthermore, the body temperature fluctuates over the course of the day. It is usually lower in the morning, higher in the afternoon and goes down a little again in the evening. Other factors that affect body temperature may be: the patient‘s particular activity, metabolic rate or medications taken. The normal body temperature also tends to drop with increasing age. The normal temperatures are listed in the following table according to the age of the patient and measuring point. Temperatures measured at different parts of the body, even if they are measured at the same time, must not be directly compared with one another, as body temperature differs between measuring points.

Temperature measuring points

Normal body temperatures according to patient age 0-2 years

3-10 years

11-65 years

›65 years

Ear

97,5° - 100,4°F 36,4° - 38,0°C

97,0° - 100,0°F 36,1° - 37,8°C

96,6° - 99,7°F 35,9° - 37,6°C

96,4° - 99,5°F 35,8° - 37,5°C

Mouth

-

95,9° - 99,5°F 35,5° - 37,5°C

97,6° - 99,6°F 36,4° - 37,6°C

96,4° - 98,5°F 35,8° - 36,9°C

Heart

97,5° - 100,0°F 36,4° - 37,8°C

97,5° - 100,0°F 36,4° - 37,8°C

98,2° - 100,2°F 36,8° - 37,9°C

96,6° - 98,8°F 35,9° - 37,1°C

Rectum

97,9° - 100,4°F 36,6° - 38,0°C

97,9° - 100,4°F 36,6° - 38,0°C

98,6° - 100,6°F 37,0° - 38,1°C

97,1° - 99,2°F 36,2° - 37,3°C

Armpit

94,5° - 99,1°F 34,7° - 37,3°C

96,6° - 98,0°F 35,9° - 36,7°C

95,3° - 98,4°F 35,2° - 36,9°C

96,0° - 97,4°F 35,6° - 36,3°C

References: Chamberlain, J, Terndrup, T., et al. (1995) Determination of Normal Ear Temperature with an Infrared Emission Detection Thermometer. Annals of Emergency Medicine, Volume 25, Issue 1, Pages 15-20 Braim. S., Preston, P., and Smith, R. (1988) Getting a better read on thermometry. RN. 1998 Mar; 61(3):57-60 Munk, P, Woods, S, Leduc, D., et al Canadian Paediatric Society Statement; Temperature Measurement in Paediatrics; Paediatric Child Health Vol 5 No 5: July/ August, 2000 Brunner, L. and Suddarth, Dl, et.al. (1982) The Lippincott Manual of Nursing Practice, Third Edition; J. B. Lippincott Company, Philadelphia, PA; 1982; p.1145 Houdas, Y. and Ring, E. F. J.. Human Body Temperature, Its Measurement and Regulation; Plenum Press, NY, 1982; p.81-87.

ri-vital OVERVIEW OF FUNCTIONS

52

4.3 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 in the Settings menu (Setup button), see section 6.2.

4.4 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, with the optional predictive thermometer approx. 20 hours. A symbol on the display indicates the battery‘s remaining charge. Connect the device to a mains socket 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.

4.5 Device front ri-vital optionally with Predictive Thermometer or ri-thermo® Infrared thermometer

A

B K

C

I

E D L

F G

H J

ri-vital OVERVIEW OF FUNCTIONS

53

A B C D E F G H I J K L

Carrying handle Coiler for sensor cable Sensor holder with sensor TFT display with illumination On/Off button Charge indicator Operating buttons Predictive thermometer extension module (optional) Probe cover box (optional) Infrared thermometer extension module (optional) Mains adapter connector Charge indicator

5. POWER SUPPLY The device can be mains operated 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 (K) 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). If no SpO2 measurement is taken and no blood pressure measurement is started either, then the entire device turns itself off in about 10 minutes. This prevents accidental depletion of the battery. In battery operation, the device shows the remaining charge with a symbol (L) in the lower part of the display. This display has a large tolerance because various parameters, such as ambient temperature, also affect the battery.

ri-vital POWER SUPPLY

54

P N

K M

Left side view M N K O P

Right side view

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

6.OPERATING CONTROLS / BASIC SETTINGS 6.1 Basic settings menu After pressing the On/Off button the Riester logo appears on the screen,the Print button must be pressed within 5 seconds to arrive in the Basic settings menu. Set language Set time Set date Delete memory Leakage test Manometer mode Temperature unit Time format

Only for technical service personnel! Only for technical service personnel!

The settings can be highlighted yellow with the  menu buttons and changed with the Setup button. To exit the menu, press the  menu button until the End-Back setting is reached and confirm the basic settings with the Setup button.

ri-vital OPERATING CONTROLS / BASIC SETTINGS

55

6.2 Settings menu

I After pressing the On/Off button the main screen appears after 5 seconds, you arrive in the Settings menu by pressing the Setup button. Pulse signal Activate NIBP mode Cuff pressure Exit

(adult oder neonate)

The „NEO“ setting must only be used for neonates and infants with an arm circumference of less than 13 cm. Risks with incorrect settings for infants measurement: If a blood pressure measurement is carried out on a newborn infant with the wrong setting (adult), the ri-vital recognizes the wrong setting by the connected neonatal cuff and immediately stops the measurement or inflating. There are no risks arising from incorrect adjustment. The permanent presetting is only used for easier operation in certain surroundings, e.g. the inflation pressure for patients who are mostly hypertonic can be set higher from the outset. The settings can be highlighted yellow with the  menu buttons and changed with the Setup button. To exit the menu, press the  menu button until the End-Back setting is reached and confirm the settings with the Setup button.

ri-vital OPERATING CONTROLS / BASIC SETTINGS

56

6.3 Main screen

C A G

J

B F H

D E

A) Sensor pulsoximeter Status display Sensor crossed out or sensor with arrow / SpO2 reading Pulse bar display B) Pulse and perfusion index display C) Systolic blood pressure NIBP error message D) Mean arterial blood pressure (MAP) Active NIBP mode (only neonate display) E) Diastolic blood pressure F) Body temperature display (Only with optional predictive thermometer G) Pulsoximeter plethysmogram H) Battery charge status I)

Charge indicator (is turned off when the battery is fully charged)

J)

Error display (only appears with error message)

ri-vital OPERATING CONTROLS / BASIC SETTINGS

57

7. PULSOXIMETRY 7.1 Sensor connector The sensor connector (N) 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. 7.2 SpO2 measurement After the sensor has been affixed to the patient, the segments of the bar indicator (A) will start to pulsate. After a short time the readings (A) (B) will appear on the display. The readings are updated once per second. A symbol with crossed-through sensor appears in the status display (A) if the sensor is not connected. The sensor symbol with arrow appears if the patient is not connected.

Perfusion index: Measurement of the perfusion index (PI), this PI allows evaluation of the peripheral perfusion of the tissue measured, from which conclusions can be drawn about the quality of the measurement and the blood circulation. Level 1 Level 2 Level 3 Level 4 Level 5 Level 6 Level 7

ri-vital PULSOXIMETRY

58

< 0.25 % 0.25 % - 0.5 % 0.5 % - 1.0 % 1.0 % - 2.0 % 2.0 % - 4.0 % 4.0 % - 8.0 % > 8.0 %

Pulse oximeters Sensors:

all PEARL sensors from the Riester program Wavelengths: 660 nm (red) 890 nm (infrared) Intensity: 3.8 mWmax. Calibration: functional saturation Measuring range: SpO2 0-100% (display range: 0 - 99%) Pulse 30-250 min-1 Accuracy: SpO2 Normal perfusion, no artefacts 1) 2) +/- 2% between 70 - 100%, not specified Reduced perfusion 1) 3) +/- 3% between 70 - 100%, not specified Movement 1) 4) +/- 3% between 70 - 100%, not specified Accuracy: Pulse normal perfusion, no artefacts 5) +/- 3 beats Movement 4) +/- 3 beats Reduced perfusion 5) +/- 3 beats Display: Oxygen saturation (updated values are displayed every second), pulse rate, plethysmogram (amplitude is not proportional to the perfusion at the measuring site), bar display, Perfusion display, Trend Graphic: Plethysmogram with normalized amplitude, the amplitude is not an indicator of perfusion of patients (see perfusion chart). 7.3 Pulse signal With the pulse signal switched on, each detected pulse beat is indicated with a brief acoustic signal. The signal‘s pitch changes with the value of the oxygen saturation. This pulse signal can also be deactivated in the Settings menu. Please note: no alarm function PLEASE NOTE: no alarm function

ri-vital PULSOXIMETRY

59

7.4 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).

8. BODY TEMPERATURE MEASUREMENT WITH THE PREDICTIVE THERMOMETER 8.1 Probe covers – application and removal A) Open the probe cover box by lifting and pulling the tab on the upper corner. B) Insert the box with the probe covers from above into the slot. (In order to avoid infections, never interchange or use opened boxes that have been used with blue or red thermometer probes). C) Remove the thermometer probe from the slide compartment. This automatically switches on the thermometer. D) As a reminder to apply or remove the probe cover, a probe symbol with flashing probe cover is displayed before applying or removing the probe cover. . E) Insert the probe tip of the thermometer probe into a probe cover in the box. Press the grip of the thermometer probe until the probe cover noticeably clicks into place. F) Take the relevant temperature reading (oral, axillar or rectal temperature).Please use the respective thermometer probe for the purpose. The measurement is concluded once the final temperature value is displayed G) Press the upper button on the thermometer probe to eject the used probe cover into a waste container. H) Remove, dispose of and replace the empty box.

ri-vital PREDICTIVE THERMOMETER

60

8.2 Replacing the thermometer probes / inserts A) To protect against infection for measurement of ORAL and AXILLAR temperature, only use BLUE thermometer probes. The RED thermometer probes must only be used for measurement of RECTAL temperature. (In order to avoid infections, never interchange or use opened boxes that have been used with blue or red thermometer probes). B) To remove or replace the thermometer probes, hold the insert on both sides with thumb and forefinger of one hand whereby the forefinger is placed on the pushbutton on the back of the insert. C) Press the press-button inwards until the lock is released, then push the insert upwards and pull it off the housing.

l k th D) N Now unlock the BLUE or RE RED connection piece of the thermometer probe by lifting the tab (1), the connection piece (2) can be removed from the insert.

E) Before the conne connection piece of a thermometer probe is reused, the insert should be thoroughly cleaned/disinfected as described and also the thermometer probe. F) The connection piece of the thermometer probe, as well as the previously removed connection piece, is attached aligned straight and is pushed into the insert until it noticeably locks in place.

ri-vital PREDICTIVE THERMOMETER

61

G) Aligned as shown in the picture on the right with the tip of the slot ahead, the insert is now pushed into the housing until the press-button has noticeably locked into place. H) The predictive thermometer is ready for use again.

8.3 Oral and axillary measurement: A) For measurements of the ORAL temperature, insert the probe tip into the pocket under the tongue on either side of the tongue frenulum (the vertical tissue fold in the middle of the tongue) and push it towards the back. B) Remove the thermometer probe and attach a probe cover. The thermometer switches on automatically. C) The symbol indicating the ORAL and AXILLARY mode appears on the display. The symbol for the RECTAL mode cannot be displayed if a BLUE thermometer probe is connected.

8.4 Oral measurement: A) For measurements of the ORAL temperature, insert the probe tip into the pocket under the tongue on either side of the tongue frenulum (the vertical tissue fold in the middle of the tongue) and push it towards the back.

NOTE: Accurate readings can only be obtained as shown in one of these two heat pockets. Temperature measurements in other areas of the mouth can lead to inaccurate readings.

ri-vital PREDICTIVE THERMOMETER

62

B) The patient‘s mouth must be CLOSED. C) Hold the thermometer probe firmly at the respective site until the temperature is displayed. Moving the probe during a measurement can impair the capacity of the thermometer to measure the temperature at the site and increase the duration before a reading is obtained. Press the upper button on the thermometer probe to eject the used probe cover into a waste container.

8.5 Axillary measurement: A) To measure the axillary temperature, request the patient to raise their arms and then place the tip of the thermometer probe with probe cover directly on the patient‘s skin. Press gently to ensure good contact. In order to achieve a highly accurate measurement result, place the tip of the thermometer probe with the probe cover directly on the patient‘s skin. B) Request the patient to lower their arms and to lie still. Keep the thermometer probe almost parallel to the arm.

ri-vital PREDICTIVE THERMOMETER

63

C) The measurement is concluded once the final temperature value is displayed. D) Press the upper button on the thermometer probe to eject the used probe cover into a waste container.

8.6 Measuring the rectal temperature: A) Make sure that the RED thermometer probe is properly inserted. B) Remove the thermometer probe and attach a probe cover. The thermometer switches on automatically. C) A symbol for the RECTAL mode is displayed if a RED thermometer probe is connected. D) Use a medically safe lubricant, as required. E) Insert the thermometer probe in the patient‘s rectum. In order to ensure good tissue contact, angle the thermometer probe slightly after insertion. Moving the probe during a measurement can impair the capacity of the thermometer to measure the temperature at the site and increase the duration before a reading is obtained. F) The recommended insertion depth 12-19 mm (0.5-0.75 inch) for adults and 6-13 mm (0.25-0.5 inch) for children. G) If two short acoustic signals may be heard, this means that the device has been switched to the DIRECT mode (the slow mode) for this temperature measurement. H) The measurement is concluded once the final temperature value is displayed. I) Press the upper button on the thermometer probe to eject the used probe cover into a waste container.

ri-vital PREDICTIVE THERMOMETER

64

8.7 Oral, rectal and axillary measurement: A) If a „D“ appears on the main screen in the temperature display area, this means that the device has been switched to the direct mode (the slow mode) for this temperature measurement. The predictive thermometer normally works in the predicting mode in order to deliver fast and accurate temperature measurements. However, if no measuring point is recognised or the temperature does not stabilise, the thermometer automatically switches to the direct mode and then works as a temperature monitor The predictive thermometer also switches automatically into the direct mode if the ambient temperature is over 35 °C (95 °F). B) After inserting the thermometer probe in the slide compartment, the measured temperature is shown on the main screen until the thermometer probe is removed again or the ri-vital is switched off.

9. Blood pressure measurement: 9.1 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 out 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. The cuff must be placed at the height of the right atrium. Take care that the patient is sitting comfortably, not having his legs crossed, his feet flat on the floor, his back and arms must be supported by a suitable chair. The position of the operator must be in the immediate vicinity of the patient, the ME device with the control panel and the cuff. Should an unexpected measured value occur, the operator can act immediately, i.e. he should check the correct position of the cuff, the cuff hose and the setting of the ME device and, if necessary, start a new measurement. Details of the environmental and operational factors that may affect the performance of the ME device and / or the blood pressure measurement are e.g. (arteriosclerosis), low blood flow, diabetes, age, pregnancy, preeclampsia (pregnancy hypertension), renal insufficiency, patient movement, tremors, chills). Since this ME device is used exclusively in hospitals and medical practices, these possible causes are known to trained personnel, doctors and operators.

ri-vital BLOOD PRESSURE MEASUREMENT

65