• • ! Do not place the NIBP cuff over a wound, as this can cause further injury. Do not place the NIBP cuff on the same or adjacent arm to a mastectomy, or where the lymph nodes were removed, or if a shunt is on that arm. This can lead to bruising, inaccurate readings, or negatively impact the drainage of fluids because of temporary interference to blood flow. CAUTION • Only use recommended MRI NIBP cuffs and tubing identified in section 9.2.
6.4.3. NIBP Patient Application When positioning the patient, routine NIBP measurements (including for the condition hypertension) require the patient to remain silent, still and relaxed, with legs uncrossed and arms supported. Note that during MRI procedures, patients are typically lying down with their legs uncrossed and arms supported as needed for the MRI scan. A five minute waiting period is recommended before starting readings. Ensure that the cuff is at the level of the right atrium of the heart. 1.
• • • • • • • 6.4.4. There are no holes or cracks in the cuff bladder or cuff tube. All residual air is squeezed out of the cuff before wrapping it around the arm. The symbol indicating the center of the bladder is over the artery. The cuff is not loose. The cuff is at heart level. The cuff tubes or NIBP tube are not kinked or squeezed together. Non-invasive blood pressure is selected to be displayed through Monitor Setup patient parameters menu. Changing Frequently Used NIBP Settings 6.4.4.1.
6.4.6.
1. 2. 3. 4. 6.5.3. Measurement Unit Current Vital Sigh Alarm Limits OVR/UND for Temp extended range <30.0 °C or >44.0 °C(<86.0°F or >111.2°F ), accuracy ± 0.4 °C Temperature Patient Application 6.5.3.1. Surface Temperature Application Perform the following procedure to apply the fiber-optic temperature sensor to a patient: 1. Carefully uncoil the sensor, avoid knotting or kinking the fiber optic cable 2. Inspect sensor for damage, including tears or deformations 3.
.5.5. Temperature Alarm Limits, Celsius Adult Temp Pediatric Temp Neonatal Temp 6.5.6. Default Low 36 36 36 Default High 39 39 39 High Limit Range 25-40, Off 25-40, Off 25-40, Off Temperature Messaging Message Temp Inop Temp Probe Fail OVR / UND 6.5.7. Low Limit Range Off, 25-40 Off, 25-40 Off, 25-40 Trigger Condition Hardware or software failure detected Broken sensor detected or a sensor is not attached properly Indicating Temp extended range < 30.0 °C or > 44 C°(<86.0°F or >111.
. Using the Recorder The optional 3885-B Base Station recorder provides hard copies of up to two waveforms and trend information. NOTE • The 3880 MRI Patient monitor does not have an internal recorder. Printing can only be done if the system is communicating with the optional 3885-B Base Station. The Base station unit houses and drives the strip chart recorder in response to Record or Print requests from the 3880 Monitor or 3885-T Remote Tablet hard (Record) and soft (Print) keys. 7.1.
3. Select “Trace Delay” 4. Select desired delay 5. Touch Back button to close the menu 7.2.4. Auto Strip Auto strip allows the automatic report feature of the recorder to be switched ON and OFF. The auto strip will automatically print when a clinical alarm is detected. To enable the Auto Strip follow these steps: 1. Press the SETTINGS button 2. Select “Recorder Setup” 3. Toggle “Auto Strip” ON and OFF 4. Touch Back button to close the menu 7.2.5.
The term “Printing” is used herein to refer to using the strip chart recorder as a printer of text and numeric information, such as the Tabular Trend table. Strip “Recording” is a specialized print out of waveform data as described in 7.2.7 and 7.2.8 above. See section 5.5 for instruction to print Trends.
8. Pre-Use Operator Verification, Troubleshooting and User Maintenance 8.1. Overview Check the following items prior to monitoring to ensure completion of all essential preparations. Items that are broken, missing, plainly worn, distorted, or contaminated must be replaced immediately. The 3880 system must not be repaired other than in accordance with written instructions provided by IRadimed. The device shall not be altered without written approval of IRadimed.
8.1.2. Checking a Battery The user replaceable battery packs utilized in the 3880 patient monitor can be checked outside of the monitor. This feature allows facilities with multiple batteries to proactively select a battery that has a desired charge level prior to inserting it into the system. To check a batteries charge follows these steps: 1. Locate the button on the rear corner of the battery (1) 2. Depress the button and the LED indicators will momentarily show the charge status. (2) 8.2.
• Occlude the sampling line and check that the message “Occlusion” appears within 30 seconds NIBP • Check that the pressure values are displayed for all cuff sizes Temperature • Check that the temperature value is displayed when the cable is connected Recorder • Check that the strip chart recorder is functional Alarms • Turn the monitoring system on and check that the Red, Amber and blue Tri-Color TriColor Alarm Dome Light are lit momentarily • Check that the speaker gives and audible tones at the desired
8.4. Care and Cleaning 8.4.1. Introduction For safe and reliable function and operation of the monitor, regular care has to be carried out in accordance with manufactures guidelines. Use only manufactures approved substances and methods to clean and disinfect your equipment. The warranty does not cover damage caused by unapproved substances or methods. IRadimed makes no claims regarding the efficacy of the listed chemicals or methods as a means for controlling infection.
8.4.3. Cleaning & Disinfecting The 3880 system should be cleaned on a regular basis. If there is heavy pollution and/or lots of dust and sand at/in your facility, the 3880 monitor should be cleaned more frequently. Recommended cleaning agents are: • Mild Soap (diluted) • Ammonia (diluted) • Isopropanol (70%) • Chloramine (5%) • Glutaraldehyde (2%) • Ethyl Alcohol Based (60-95%) • Chlorine/Bleach Based (4-6%) • Iodine Based (0.5-5%) • Phenols (0.
8.5. User Maintenance 8.5.1. Overview Before every use, a thorough inspection should be performed. Follow these guidelines when inspecting the 3880 monitor: • Make sure that the environment and power supply meet the requirements. • Inspect the 3880 system and its accessories for mechanical damage. • Inspect all power cords for damage, and make sure that their insulation is in good condition. • Make sure that only specified accessories are applied. • Inspect if the alarm system functions correctly.
Problem Possible Cause Blown Fuse(s). AC power source has incorrect voltage. Screen Damaged. 2 3885-T will not turn on. Power ON [ I] key not pressed. Battery depleted. Solution 1) Replace the fuse in the power supply box (P/N 1120). Refer to the service manual for proper fuse type and procedure. 1) Switch AC power cord to a power receptacle with sufficient voltage. Refer to the service manual for voltage requirements.
3 Problem 3885-B will not turn on. Possible Cause Power ON key not pressed. Blown Fuse(s). No AC power AC power source has incorrect voltage. 4 3886 will not turn on. Power ON key not pressed. Blown Fuse(s). No AC power Solution 1) Toggle the power switch to the ON position. Listen and feel for the tactile feedback to confirm the button has been properly pressed. 1) Replace the fuse in the rear of the 3885T Refer to the service manual for proper fuse type and procedure.
Problem 5 ePOD or oPOD will not turn on Possible Cause AC power source has incorrect voltage. Power ON key not pressed. Insufficient battery life Solution 1) Switch AC power cord to a power receptacle with sufficient voltage. Refer to the service manual for voltage requirements. 1) Toggle the power switch to the ON position. 1) 2) 3) 4) 6 3880 will not operate on battery. Battery not properly charged.
Problem Possible Cause Aged battery won't hold charge. Battery is in sleep mode. 7 Short battery run time. Battery not charged long enough. Solution 1) Plug AC Adapter power cord into an AC outlet immediately. 2) Plug AC Adapter into the circular power receptacle on the rear of the device. 3) Wait until battery is fully charged. 4) Press the button on the exterior of the battery pack. If no LED’s illuminate replace the battery pack before use.
Problem 8 Battery is hard to remove. 8.6.2. 1 Possible Cause Aged battery will not hold charge. Swollen Battery Cells. Troubleshooting Alarm Related Problems Problem No Audible alarm tone heard. Possible Cause Alarm volume set too low for the use environment. Faulty alarm speaker. 2 Solution 1) Plug AC Adapter power cord into an AC outlet immediately. 2) Plug AC Adapter into the circular power receptacle on the rear of the device. 3) For 1133 batteries only.
3 Problem The unit is in Alarm mode with lights flashing but no audible alarms can be heard. Possible Cause The 2 minute Alarm Silence button is activated. Audible volume set too low to be heard. 8.6.3. 1 Problem Buttons will not function. Possible Cause Key not pressed firmly. Programmed settings are restored to default on power up. 3880 turned off for longer than 30 seconds between uses. Volatile memory may not store due to internal Coin cell battery problem.
4 Problem 3885-T Remote will not communicate to a selected 3880 or drops out. Possible Cause 3880 is not turned ON. 3880 is not within wireless range. 1) 1) 2) Software incompatibility. 1) Incorrect Channel. 1) 2) 3) 4) Multiple system components on the same wireless network channel. 1) Loose or damaged antenna. 1) 1) Local radio interference prevents communication. 1) Solution Ensure the 3880 is turned on and is operational.
Problem Possible Cause MRI Room Attenuation. 1) 2) 3) 4) 5 ePOD or oPOD will not communicate with a 3880 3880 is not turned ON. 1) 3880 is not within wireless range. 1) 2) Incorrect Channel. 1) 2) 3) 4) 6 Printer will not print Multiple system components on the same wireless network channel.
Problem 8.6.4. 8.6.5. 1 Solution 1) Review section 7 of the operators manual Troubleshooting MRI Related Problems Problem Artifact on MR images. 1 Possible Cause Printer out of paper or paper jam Possible Cause Loose connection to cord when running on AC power. Solution Tighten AC cord connection to Monitor and power supply. Faulty Hardware. 1) Switch to battery power. 2) Disconnect the power cable from the 3880 monitor. 3) Disconnect AC power cord from the AC outlet in the MRI room.
Problem Possible Cause Incompatible lead view for the MRI scan and/or electrode placement Poor skin preparation Poor electrode placement Poor electrode quality Weak radio link QRS amplitude is less than 10 mm/mv Faulty ECG ePOD Incorrect ECG Mode selected Patient motion ECG lead not properly inserted into the ePOD Damaged ECG lead Solution Change the ECG lead view to select the best performing view for the sequence. Re-prep the patient according the application procedure found in section 6.
Problem 2 SpO2 not functioning Possible Cause All other issues SpO2 sensor is not attached to the patient. Poor SpO2 sensor placement Weak radio link Faulty SpO2 oPOD SPO2 readings are unstable or poor Sensor positioning Averaging time Patients specific anatomy Cool temperature is affecting patients perfusion Solution 1) Ensure the ePOD is on the same wireless network channel as the 3880. 2) Ensure the ECG parameter is enabled. 3) Inspect all ECG components for damage and replace as necessary.
Problem Possible Cause interference from NIBP cuff or arterial catheter.
4 Problem EtCO2 Vital Signs are not performing as expected Possible Cause All other issues NIBP values seem unstable Compromised hose or cuff Monitor has an internal leak Patients Arm Position Cuff comes off patient limb Inappropriate sized cuff Cuff applied inside out NIBP not functioning NIBP Vital Signs are not performing as expected NIBP hose or cuff is disconnected Monitor has an internal failure All other issues Solution 1) Ensure the EtCO2 parameter is enabled.
5 Problem Temperature error or intermittent function Temperature Vital Signs are not performing as expected 6 Respiration and Gases from 3886 are not performing as expected Possible Cause Temperature sensor is not securely attached to the patient. Poor Temperature sensor placement Faulty Temperature sensor All other issues Solution Re-attach Temperature sensor. Reposition/replace Temperature sensor. Replace Temperature sensor, or refer to qualified technical service representative.
8.7. Repair 8.7.1. Overview All repairs on components under warranty must be performed by authorized IRadimed service personnel. If the 3880 system fails to function properly or requires maintenance, contact your IRadimed representative. ! CAUTION • Decontaminate all equipment prior to performing any repair or before sending to IRadimed. • No repair should ever be attempted by anyone not having a thorough knowledge of the 3880 system.
8.8. Warranty IRadimed Corporation warrants the major components of the 3880 system (e.g. 3880, 3885-T Remote Tablet and 3885-B Base Station) to be free from defects in materials and workmanship for a period of twelve (12) months from the date of original delivery to the buyer or to buyer's order, provided that same is properly operated under conditions of normal use, and that periodic maintenance and service is performed. A ninety (90) day warranty applies to limited-life parts and accessories (e.g.
9. Accessories The packaging of the accessories is color coded to help identify which accessories are most likely appropriate for your particular patient. • Gray – All patient sizes • Neonatal (Birth to one month of age) – Purple • Infant (One month to two years of age) – Orange • Child (Two to Twelve years of age) – Green • Adult (Above twelve years of age) – Blue NOTE • All materials that come in contact with patients and users comply with ISO 10993-1.
Part Number Description Image Use Type 1832P Pediatric Reusable Cuff (14-21.5cm) 1832I Reusable Non-Invasive blood pressure cuff are constructed of an extremely soft, easy to clean material to provide a long usable life and support multiple patient use. Infant Reusable Cuff (9-15cm) 1833N4-10 Reusable Non-Invasive blood pressure cuff are constructed of an extremely soft, easy to clean material to provide a long usable life and support multiple patient use.
9.4. CO2/Respiration Monitoring Part Number 1842A-25 Description Image Single Use Single use standard nasal cannula 1842P-25 Pediatric Nasal Cannula (Pack of 25) Single Use Single use standard nasal cannula 1842I-25 Infant Nasal Cannula (Pack of 25) Single Use Single use standard nasal cannula 1841-25 Use Type Adult Nasal Cannula (Pack of 25) Coextruded Sample Line (Pack of 25) Single Use Sample line for use with capnography and anesthetic agent gas monitoring. For use with P/N 1849. 9.5.
9.7. Gating Part Number 1881 Description Image Use Type Universal Gating Interface Multiple Use Non-Magnetic gating interface cable for use with MRI Systems equipped with cardiac gating leads 9.8.
10. Exhibits A. Specifications 10.1.
10.1.1.2. User Interface 10.1.1.2.1. Technical Parameters Power: Feature Hard Keys: Setup Hard Keys: Soft Keys: Technical Detail Rotary On, Off Trends, Print, NIBP Start/Stop and Alarm Silence Setup and Standby Touchscreen 10.1.1.2.2. Technical Parameters Power: Feature Hard Keys: Setup Hard Keys: Soft Keys: 10.1.1.3. PODS Technical Detail Push Button On, Off Channel Selection 10.1.1.2.4.
10.1.1.4. Technical Parameters IEC: Med Device Directive: Defibrillator Protection: Defibrillator Recovery Time: 10.1.1.5. Safety Standards Technical Detail 60601-1, 60601-1-2, 60601-1-8, 60601-2-27, 60601-2-49, 80601-2-30, 80601-2-55, 80601-2-56, 80601-2-61 93/42/EEC, 2007/47/EEC Up to 5 KV During a defibrillation procedure, the ECG waveform will saturate then recover in less than 5 seconds Physical Specifications 10.1.1.5.1.
10.1.1.6. Technical Parameters Voltage Range: (All 3880 system components) Frequency Range: Max Consumption: 3880 Monitor 3885-B Base Station 3886 Multi-Gas Unit 3880 Monitor: 3885-T Remote Tablet: 3881/3882 W ireless PODS: 3880 Monitor: Power Requirements Battery Capacity Battery Operation Time Battery Charge Time Power On 3885-T Remote Tablet: 3881/3882 Wireless PODS: 3880 Monitor: 3885-T Remote Tablet: 3881/3882 Wireless PODS: Boot Time: 10.1.1.7.
10.1.1.9. Technical Parameters Technique: Data Type: Paper Speed: Recorder Technical Detail Thermal line recorder at 3885-B Base Station Single or Dual Waveform; Tabular 12.5 or 25mm/sec continuous 10.1.1.10. Technical Parameters Technique: Digital Pulses: Gating Technical Detail Cardiac or Peripheral 3.3 p-p signal with a pulse duration of 10ms ± 3ms 10.1.1.11. Vital Signs 10.1.1.11.1.
10.1.1.11.2. Technical Parameters Technique: Saturation Range: Saturation Accuracy: Saturation Resolution: Pulse Rate Range: Pulse Rate Accuracy: Pulse Rate Resolution: Wavelength Range: Emitted Light Energy Calibration Range: Minimum sensor Bend Radius SpO2 averaging time: SpO2 Technical Detail ® Masimo SET 1% - 100% ± 2.
10.1.1.11.4. Technical Parameters Technique: Range: Accuracy: Resolution: Warmup Time: Response Time: Flow Rate: Calibration: CO2 Only, Internal System Technical Detail Sidestream, Non-dispersive infrared absorption technique 0-15% CO2, or partial pressures at STP: 0-115 mmHg, or 0 - 16 kPa, ± 0.43 Vol% +8%, or ± 3.75 mmHg +8%, or ±0.5kPa +8% 1 mmHg, 0.1%, 0.1 kPa < 10 seconds (concentrations reported and full accuracy) < 5 seconds for sample, 150mS waveform response 80 ± 20 ml/min Automatic 10.1.1.11.5.
Desflurane Ethanol Isopropanol +12 % of reading @ 15 vol% No effect at 0.3 vol% No effect at 0.5 vol% Acetone / Metabolic Ketones Methane No effect at 1 vol% No effect at 3 vol% Carbon Monoxide Nitrogen Monoxide No effect at 1 vol% No effect at 0.02 vol% Oxygen No effect at 100 vol% 10.1.1.11.7. Resolution Range Accuracy 0 to 59% Accuracy 60 to 100% O2 (Part of 3886) 1% 0 to 100 % +/- 3% +/- 5% 10.1.1.11.8.
Gas System Inop Gas System Warmup LAN Conn Error Low ECG Batt Low Mon Batt Low SpO2 Batt Low Sig IQ Low Tab Batt Low Perfusion Mag Field High Multi Agent MAC Mixed Agents NIBP Cal Error NIBP Delayed NIBP Inop NIBP Leak NIBP Occlusion NIBP Over Press NIBP Time Out No Sample Line Out of Paper POST Fail Recorder Inop Recorder Off Line Radio Inop SEE MESSAGES! Sp02 Batt Crit SpO2 Noisy SpO2 Hi Light SpO2 Bad Probe SpO2 Inop SpO2 No Probe SpO2 Probe Off SpO2 Searching SW Mismatch Temp Inop Temp Probe Fail Wrong
Watch Dog Fail Safe timeout indicated by continuous audio alarm tone and flashing red alarm dome. C. Repair All repairs on products under warranty must be performed by Iradimed Corporation personnel, or an authorized Iradimed Corporation Service and Repair Center. Unauthorized repairs will void the warranty. If a device fails to function properly or requires maintenance, contact Iradimed Corporation Technical Service at 1-407-677-8022 within the U.S., +001-407-677- 8022 from outside the U.S.
D. Masimo SETTM Technology D.1. Masimo SET Principles of Operation The Masimo SET® MS pulse oximeter is based on three principles: 1. Oxyhemoglobin and deoxyhemoglobin differ in their absorption of red and infrared light (spectrophotometry). 2. The volume of arterial blood in tissue and the light absorbed by the blood changes during the pulse (plethysmography). 3. Arterio-venous shunting is highly variable and that fluctuating absorbance by venous blood is a major component of noise during the pulse.
through an adaptive correlation canceler (ACC) which yields an output power for each possible value of R (i.e., each possible SpO2 from 1% to 100%). The result is a Discrete Saturation Transform (DST™) plot of relative output power versus possibleSpO2 value as shown in the following figure where R corresponds to SpO2 = 97%: MEASURED ARMS VALUES Range ARMS 90-100 % 1.30 % 80-90 % 1.78 % 70-80 % 2.80 % Range ARMS 70-100 % ± 2.
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E. Internal CO2 Only, and Masimo Multi-Gas Systems Detail Operation The 3880 MRI Patient monitoring system has two options for gas measurement. There being a ‘built in’ CO2/Respiration only option and an externally packaged Multi-Gas option with full automatic anesthetic agent identification as well as ‘fast’ parametric O2, known as P/N 3886. The ‘built in’ CO2 only option is housed within the 3880 monitor unit and operable to the full magnetic limits of the 3880 monitor unit, 30,000 Gauss.
OR Operating Room rise time Time required to achieve a rise from 1O % to 90 % of final value when a step function change in concentration occurs at the sampling site sampling line config A sampling line configuration consists of a Nomoline Family sampling line connected to either a patient breathing circuit or spontaneous breathing patient STP Standard Temperature and Pressure: 101.
E.2. Theory and design, 3886 Multi-Gas System E.2.1. Gas measurements and identification The measurement of CO2, N2O and anesthetic agents is based on the fact that different gases absorb infrared light at specific wavelengths. The analysis of respiratory gases by the ISA gas analyzers are therefore performed by continuously measuring the infrared light absorption in the gas flow through an infrared spectrometer.
measurement accuracy. In addition to the measurement filters, two optical filters appropriately located within the 4 to 10 µm range are used as references. E.2.2. Oxygen measurement, Paramagnetic Oxygen does not absorb infrared light to the same extent as other breathing gases and is therefore measured using alternative methods. The ISA OR+ analyzer is fitted with a paramagnetic oxygen sensor.
E.2.3. Sampling A sidestream gas analyzer continuously removes a gas sample flow from the respiratory circuit, for example a nasal cannula, a respiratory mask or the Y-piece of an intubated patient. The gas sample is fed through a sampling line to the gas analyzer. The sampled gas is usually warm and humid, and cools down in contact with the wall of the sampling line. Water therefore condenses in form of droplets on the inner wall of the sampling line.
be sure to use a Masimo T-adapter that samples the gas from the center of the T-adapter (see below). See section 12 for ordering details. Flow control During normal operation, a sidestream gas analyzer is continuously fed with a small sample gas flow. To pull the gas through the sampling line and maintain a steady flo w, a high-precision flow control system is required. In !SA sidestream gas analyzers, the flow control system consists of an integrated micro pump, a zero valve and a flow controller.
in Masimo Gas Master. 4. Wait about 1O seconds until the "Atm press - cuvette press [kPa]"value as shown by the Masimo Gas Master is stable. Note the value. 5. Wait additional 10 seconds. 6. Check that the "Atm press - cuvette press [kPa]"value has not changed more than 3 kPa in 10 seconds. 7. If the "Atm press - cuvette press [kPa}" value changes more than 3kPa in 10 seconds, check tubing and fittings for leakage. If the problem persists, return the analyzer to Masimo Sweden (see section 9).
7. Verify the gas readings Notes: If the calibration process fails, the flag SPAN_ERR is set, and will stay active until the next successful calibration is passed. As long as no sampling line is connected, an ISA gas analyzer stays in a low-power, sleep mode. Once the sampling line is connected, the ISA gas analyzer switches to measuring mode and starts delivering gas data. E.2.4.
E.2.6. Gas data considerations Gas measurement units Effects of humidity The partial pressure and the volume percentage of CO2 , N2O , O2 and anesthetic agents depend on the amount of water vapor in the measured gas. The O2 measurement will be calibrated to show 20.8 vol% at actual ambient temperature and humidity level, instead of showing actual partial pressure. 20.8 vol% O2 corresponds to the actual O2 concentration in room air with 0.
Oxygen, O2: ISA OR+ sidestream units automatically compensates for spectral broadening caused by oxygen Below is the typical effect if using the default value (21 vol% 02) when measuring on gas mixtures with different O2 concentrations: O2 concentration in gas mix Effect on gas reading 21 vol% 0 % relative 5.0 vol% 50 vol% -2.76 % relative 4.9 vol% 70 vol% -4.67 % relative 4.8 vol% 95 vol% -7.05 % relative 4.7 vol% Displayed value if true concentration is 5.0 vol% CO2 E.3. Specifications E.
E.3.2. Gas Analyzer Sensor head 2 to 9 channel NDIR type gas analyzer measuring at 4 to 10 µm. Data acquisition rate 10 kHz(sample rate 20 Hz/channel) Compensations ISA OR+: Calibration No span calibration is required for the IR bench. An automatic Zeroing is performed typically 1 to 3 times per day. Warm-up time ISA OR+: Automatic compensation for pressure and temperature.
E.3.4. Accuracy - all conditions The following accuracy specifications are valid for all specified environmental conditions except for interference specified in section E3.5 (effects from water vapor partial pressure on gas readings) and section E3.6 (interfering gas effects). Gas Accuracy CO2 ±(0.5 kPA + 8% of reading) ±(3.75 mmHg + 8% of reading) N2O ±(2 kPA + 5% of reading) ±(15 mmHg + 5% of reading) Agents2 ±(0.2 kPA + 10% of reading) ±(1.
Note 1: Note 2: Note 3: Note 4: Note 5: Note 6: Negligible interference, effect included in the specification “Accuracy, all conditions” above. Negligible interference with N2O / O2 concentrations correctly set, effect included in the specification “Accuracy, all conditions” above. Interference at indicated gas level. For example, 50 vol% Helium typically decreases the CO2 readings by 6%. This means that if measuring on a mixture containing 5.
F. Symbol Conventions and meanings Symbol Used for or Symbol Used For Manufacturer CE Mark Manufacturer/ Date of Manufacture Do Not Reuse Use by date; do not use after the year (YYYY), month (MM) Federal Communications Commission radio certification Consult Instructions for Use Authorized EU Representative Non sterile or MR Safe: Completely safe for use with no potential for interaction with the MR field.
Shock – Radio Source Not for General Waste Gas Inlet Gas Outlet Power On Power Off Battery, negative contact + Direct Current Universal Serial Bus (USB) Battery, positive contact Alternating Current IPX1 Protected against harmful effects of dripping water per IEC 60529 Alarm sound system is capable of audio sound triggered by alarms/alerts Audio Alarms Off; ALARM conditions can visually indicate, if ALARM not OFF Audible Alarms Paused (includes 120 second countdown timer adjacent to symbol
RECORD button: Starts strip chart recorder for hard copy printout at recorder in the optional 3885-B Base Station NIBP START/STOP button: Initiates a NIBP measurement when one is not in progress, or stops an NIBP in progress. Holding START/STOP button for 3 seconds initiates STAT readings.
G. Manufactures Technical Declaration EMC Information Tables as required by EN 60601-1-2:2007 Clause 5 In accordance with EN 60601-1-2:2007 Medical Electrical Equipment – Part 1-2: General requirements for safety – Collateral standard: Electromagnetic Compatibility – Requirements and tests 1. “Medical Electrical Equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in the Accompanying Documents” (the following tables). 2.
3880 System Table 202—Guidance and manufacturer’s declaration— electromagnetic immunity—for all EQUIPMENT and SYSTEMS Guidance and manufacturer’s declaration—electromagnetic immunity The 3880 System is intended for use in the electromagnetic environment customer or the user of the 3880 System should assure that it is used in such an environment. Immunity test IEC 60601 test level ±6 kV contact ±6 kV contact ±8 kV air ±8 kV air Floors should be wood, concrete, or ceramic tile.
Table 203—Guidance and manufacturer’s declaration— electromagnetic immunity—for LIFE-SUPPORTING EQUIPMENT and SYSTEMS Guidance and manufacturer’s declaration—electromagnetic immunity The 3880 System is intended for use in the electromagnetic environment customer or the user of the 3880 System should assure that it is used in such an environment.
3880 System Table 205—Recommended separation distances between portable and mobile RF communications equipment and the EQUIPMENT or SYSTEM— for LIFE-SUPPORTING EQUIPMENT and SYSTEMS Recommended separation distances between portable and mobile RF communications equipment and the 3880 System The 3880 System is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
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