Alarms Resetting Alarms The alarm pause time is two minutes. When the pause time expires, the alarm paused status is automatically deactivated. You can also cancel the alarm paused status by tapping [Alarm Pause] in the quick keys area. NOTE • 6.9 When the TM80/TM70 is connected to the CMS and the function of remotely pausing alarms is enabled at the CMS, alarms can be paused either at the TM80/TM70 or at the CMS.
Latching Alarms Alarms ■ A √ mark appears before the alarm message, indicating that the alarm is acknowledged. ■ The color of the parameter numeric background corresponds with the alarm priority, but the parameter numeric does not flash. 6.9.2 Resetting Technical Alarms After the alarm system is reset, technical alarms give the following alarm indicators: ■ The ■ Some technical alarms are cleared and no alarm indications are given. ■ Some technical alarms are changed to prompt messages.
7 Monitoring ECG Introduction...............................................................................................................7-2 Safety............................................................................................................................7-2 Preparation for Monitoring ECG .........................................................................7-3 Changing the ECG Settings ..................................................................................
Introduction 7.1 Monitoring ECG Introduction The electrocardiogram (ECG) measures the electrical activity of the heart and displays it on the monitor as a waveform and a numeric. ECG monitoring provides 3-, 5-, and 6-lead ECG monitoring, ST-segment analysis, arrhythmia analysis, and QT/QTc measurements. Operations such as configuring QRS threshold, adjusting ST point/ISO point/J point, setting ST template/QT template are performed at the CentralStation.
Monitoring ECG Preparation for Monitoring ECG NOTE • After defibrillation, the waveform recovers within 10 seconds applied in accordance with the manufacturer’s instructions for use. 7.3 Preparation for Monitoring ECG 7.3.1 Preparing the Patient’s Skin Proper skin preparation is essential in obtaining an accurate ECG reading. Electrode sites should be clean and dry and should provide a smooth flat surface.
Preparation for Monitoring ECG Monitoring ECG NOTE • 1. Using a Transcutaneous Electrical Nerve Stimulator (TENS): Since a TENS unit transmits electrical impulses, avoid placing ECG electrode near the TENS electrodes. ECG electrodes may need to be repositioned and the ECG lead viewed may need to be adjusted until the optimum ECG tracing is obtained. Peel the backing off of the electrode. Visually inspect the contact gel medium for moistness.
Monitoring ECG Preparation for Monitoring ECG NOTE • It is recommended that the electrodes be changed at least every 24 to 36 hours to maintain proper contact with the skin, although some patients may require more frequent changing. Do not reapply disposable electrode. Try to avoid reusing the exact same electrode site during reapplication. If an electrode becomes wet with fluid, change the electrode. 7.3.3 Setting ECG Lead Labeling 7.3.3.
Preparation for Monitoring ECG 7.3.4.1 Monitoring ECG Standard 3-Leadwire Electrode Placement A 3-wire lead set can monitor one of three ECG vectors (I, II, or III). The recommended 3wire lead placement is as follows: LA RA L R LL F 3-wire lead placement (IEC) 3-wire lead placement (AHA) ■ Place the RA (white) electrode under the patient’s right clavicle, at the midclavicular line within the rib cage frame.
Monitoring ECG Preparation for Monitoring ECG ■ Place the RA (white) electrode under the patient’s right clavicle, at the midclavicular line within the rib cage frame. ■ Place the R (red) electrode under the patient’s right clavicle, at the midclavicular line within the rib cage frame. ■ Place the LA (black) electrode under the patient’s left clavicle, at the mid-clavicular line within the rib cage frame.
Preparation for Monitoring ECG 7.3.4.4 Monitoring ECG AHA IEC Electrode Placement LA (black) L (yellow) Under the patient’s left clavicle, at the mid-clavicular line within the rib cage frame LL (red) F (green) On the patient’s lower left abdomen within the rib cage frame. RL (green) N (black) On the patient’s lower right abdomen within the rib cage frame. Va (brown) Ca (white) The Va (Ca) electrode is placed in any one of the position from V1 (C1) to V6 (C6).
Monitoring ECG Preparation for Monitoring ECG Pacer RA R Pacer L LA F LL 3-wire lead placement for a pacemaker patient (AHA) 3-wire Lead Placement for a Pacemaker Patient (IEC) Pacer RA LA V RL Pacer R C F N LL 5-wire Lead Placement for a Pacemaker Patient (AHA) L 5-wire Lead Placement for a Pacemaker Patient (IEC) Pacemaker RA (R) LA (L) V6 (C6) V5 (C5) V1 (C1) V4 (C4) LL (F) RL (N) V2 (C2) V3 (C3) 6-wire Lead Placement for a Pacemaker Patient (AHA)/(IEC) TM80/TM70 Telemetry Mo
Preparation for Monitoring ECG Monitoring ECG A pacemaker patient usually requires a different electrode patch placement configuration than a non-pacemaker patient. Do not place an ECG electrode directly over the pacemaker generator. Place the electrode patches 3 to 5 inches away from the pacemaker generator area. For example, if the pacemaker generator is located in the right subclavian area, relocate the Right Arm electrode closer in towards the center of the chest. 7.3.
Monitoring ECG Preparation for Monitoring ECG When any of the leads are off, the indications are as follows: ■ The lead off message displays on the information bar. The background color of the information bar corresponds to the alarm level. ■ A flashing circle indicates the disconnected lead. The color of the flashing circle is based on the alarm level. 7.3.6 Checking the Paced Status It is important to correctly set the patient’s paced status before you start monitoring ECG.
Changing the ECG Settings Monitoring ECG WARNING • • • • • • For paced patients, you must set [Paced] to [Yes]. If it is incorrectly set to [No], the CMS could mistake a pace pulse for a QRS and fail to alarm when the ECG signal is too weak. Do not rely entirely on rate meter alarms when monitoring patients with pacemakers. Always keep these patients under close surveillance.
Monitoring ECG 7.4.1 Changing the ECG Settings Configuring the ECG Setup Enter the ECG menu in either of the following ways: ■ On the main screen, tap the HR digital area or ECG waveform area to enter the [ECG] menu. ■ In the main menu, tap [Parameter Setup] → [ECG] to enter the [ECG] menu. 1. In the [Setup] section of the [ECG] menu, select the options described in the following table. Options Description Settings* Lead Placement Enters the [Lead Placement] window.
Changing the ECG Settings 7.4.2 Monitoring ECG ECG Leadwire Types ECG leadwire type has three options as follows: ■ [Auto]: the device automatically sets the leadwire type according to the leads connected. ■ [3 Lead]: the leadwire type is set to 3-lead. If the leadwire type is set to 3-lead, the [Smart Lead] option becomes [Monitored Lead]. You can select the desired lead from the [Monitored Lead] option to set the first ECG waveform displayed on the main screen.
Monitoring ECG 7.4.4 Changing the ECG Settings Configuring the Pacer 1. In the [Pacer] section of the [ECG] menu, tap the options described in the following table. Options Description Settings* Paced Selects the paced status. Unspecified, No, Yes [Unspecified] is only available for the first time you set the paced status. Refer to "Checking the Paced Status" on page 7 - 11 for details. Markers Selects the pacer indicator.
Configuring the HR Alarm Source 7.4.6 Monitoring ECG Configuring ECG Alarm Settings 1. In the [Alarms] section of the [ECG] menu, tap [ECG Alarm Setup].The [Alarm Limits] menu is displayed. 2. Configure the option described in the following table. Options Description Settings* HR/PR Configures whether to trigger the HR or PR alarm. On, Off Alarm limit range: 15 bpm to 300 bpm The default alarm upper limit is 120 bpm for adult and is 160 bpm for pediatric.
Monitoring ECG Understanding the ECG Display ◆ [Auto]: the TM80/TM70 will use the heart rate from the ECG measurements as the alarm source whenever a valid heart rate is available. If the heart rate becomes unavailable, for example the ECG module becomes disconnected, the TM80/TM70 will automatically switch to PR as the alarm source. ◆ [Both]: both HR and PR are used as the alarm source for HR/PR. NOTE • When [Alm Source] is set to [HR], systole beep comes from heart beat.
ST Monitoring 7.6.3 Monitoring ECG ECG Waveform Area The ECG waveform area displays: 1. ECG Lead 2. ECG scale bar 3. ECG waveform 4. ECG filter setting 5. ECG scale 2 1 3 5 4 7.6.4 7.7 About the ECG Waveform Area ■ The ECG waveform, scale indicator, lead, and filter settings display in the configured ECG color. ■ The ECG waveform area provides scrolling, real-time waveform data and an erase bar to provide a time indicator of oldest and new data.
Monitoring ECG 7.7.1 ST Monitoring ST Safety Information WARNING • • • • 7.7.2 ST values may be affected by such factors as some drugs or metabolic and conduction disturbances. ST deviation is often calculated at a fixed offset from the J point. Changes in heart rate may affect ST. The ST deviation measurement algorithm has been tested for accuracy. The significance of ST segment changes needs to be determined by a physician. The TM80/TM70 provides ST deviation level change information.
ST Monitoring 7.7.3 Monitoring ECG Displaying ST Numerics When [ST Analysis] is switched on, ST digital area is displayed on the screen. The location of the ST digital area is dependent on the display configurations. For how to set the location of the ST digital area, refer to "Configuring the Display" on page 4 - 2. Numerics displayed in the ST digital area are different according to the lead type: ■ When the 3-lead ECG leadwires are used, the ST digital area is not displayed.
Monitoring ECG 4. QT/QTc Interval Monitoring In the [Alarms] section, configure the options described in the following table. Options Description Settings* ST-I, ST-II, ST-III, ST-aVR, ST-aVF, ST-V, ST-Va, ST-Vb These options are displayed when [ST Alarm Mode] is set to [Absolute]. The lead label behind ST is consistent with the ECG cable type selected. On, Off Upper alarm limit range: 0.2 mV to 2.0 mV; the default is 0.2mV; the step is 0.01mV Lower alarm limit range: -2.
QT/QTc Interval Monitoring Monitoring ECG QT/QTc interval monitoring is intended for adult and pediatric patients. 7.8.
Monitoring ECG 7.8.3 QT/QTc Interval Monitoring Displaying QT/QTc Numerics and Segments After [QT Analysis] is switched on, QT digital area is displayed on the screen. The location of the QT digital area is dependent on the display configurations. For how to set the location of the QT digital area, refer to "Configuring the Display" on page 4 - 2. 2 1 3 4 5 6 1. Parameter label 2. QTc value 3. Measurement unit 4. Alarm activation state off icon 5.
Monitoring ECG Arrhythmia Monitoring Options Description Settings* Delta QTc Configures whether to trigger the Delta QTc alarm. On, Off Upper alarm limit range: 30ms to 200 ms; the step is 1ms The default is 60 ms. Alarm priority: Low, Med, High * 4. 7.9 The factory default settings are in bold. Tap to return to the previous menu. Arrhythmia Monitoring Arrhythmia monitoring is intended for adult and pediatric patients. 7.9.
Monitoring ECG Arrhythmia Monitoring CAUTION • • • 7.9.2 Since the arrhythmia detection algorithm sensitivity and specificity are less than 100%, sometimes there may be some false arrhythmias detected and also some true arrhythmia events may not be detected. This is especially true when the signal is noisy. The ECG size and minimum QRS detection threshold settings affect arrhythmia detection and heart rate calculation sensitivity.
Monitoring ECG Arrhythmia Monitoring 7.9.2.2 7 - 26 Nonlethal Arrhythmia Events Arrhythmia message Description Vent Brady The number of consecutive PVCs is greater than or equal to V brady PVC limit and the ventricular rate is less than the V brady rate limit. Extreme Tachy The heart rate is greater than the extreme tachycardia limit. Extreme Brady The heart rate is less than the extreme bradycardia limit. R on T R on T PVC is detected.
Monitoring ECG Arrhythmia Monitoring Afib P wave is absent and normal beat RR intervals are irregular. PVCs/min PVCs/min exceeds high limit. Pauses/min Pauses/min exceeds high limit. Irr. Rhythm End Irregular rhythm no longer detected for the irregular rhythm end delay time. Afib End Atrial fibrillation no longer detected for the Afib end delay time. Note: N: normal beat; V: ventricular beat 7.9.3 Changing Arrhythmia Settings 7.9.3.1 Changing Arrhythmia Alarm Settings 1.
Monitoring ECG Arrhythmia Monitoring Options Description Settings* Asystole Configures arrhythmia alarms. On, Off Asystole Delay: 3 seconds to 10 seconds The default is 5 Seconds. Alarm priority: High V-Fib/V-Tach On, Off Alarm priority: High V-Tach On, Off V-Tach PVCs: 3 beats to 99 beats; the default is 6 beats. V-Tach Rate:100 bpm~200 bpm; the default is 130 bpm. Alarm priority: High * 7 - 28 The factory default settings are in bold.
Monitoring ECG Arrhythmia Monitoring Options Description Settings* Vent Brady Configures arrhythmia alarms. On, Off V Brady PVCs:3 beats to 99 beats; the default is 5 beats. V Brady Rate: 15 bpm to 60 bpm; the default is 40 BPM. Alarm priority: High Extreme Tachy On, Off Extreme Tachy: 61 bpm to 300 bpm; the default is 160 bpm for adult and 180 bpm for pediatric. Alarm priority: High Extreme Brady On, Off Extreme Brady: 15 bpm to 119 bpm; the default is 35 bpm for adult and 50 bpm for pediatric.
Monitoring ECG Arrhythmia Monitoring Options Description Settings* Bigeminy Configures arrhythmia alarms. On, Off Alarm priority: Prompt, Low, Med, High Trigeminy On, Off Alarm priority: Prompt, Low, Med, High Tachy On, Off Tachy: 60 bpm to 299 bpm; the default Tachy threshold is consistent with the HR upper alarm limit. Alarm priority: Med, High Brady On, Off Brady: 16 bpm to 120 bpm; the default Brady threshold is consistent with the HR lower alarm limit.
Monitoring ECG Arrhythmia Monitoring Options Description Settings* Irr Rhythm Configures arrhythmia alarms. On, Off AF/Irr Rhy End Time: 0, 1 min, 2 min, 3 min, 4 min, 5 min, 10 min, 15 min, 30 min; th default is 2 Minutes. Alarm priority: Prompt, Low A-Fib On, Off AF/Irr Rhy End Time: 0, 1 min, 2 min, 3 min, 4 min, 5 min, 10 min, 15 min, 30 min; th default is 2 Minutes. Alarm priority: Prompt, Low, Med, High PVCs/min On, Off PVCs High: 1 to 100; the default is 10.
Monitoring ECG Arrhythmia Monitoring NOTE • • • • The priority of lethal arrhythmia alarms is always high. When the TM80/TM70 is connected to the CMS, any changes made either at the TM80/TM70 or the CMS will be communicated to the other side. But when lethal arrhythmia alarms are switched off at the CMS, you can change lethal arrhythmia alarms settings at the CMS only. icon is displayed on the lethal arrhythmia alarms at the TM80/TM70.
Monitoring ECG Arrhythmia Monitoring High priority chain (presented as soon as detected) Priority (High to medium) PVC Alarm Chain Nonsus VTach/Vent Rhythm Asystole V-Fib/V-Tach V-Tach/Vent Brady Extreme Tachy/Extreme Brady Beat Detection Alarm Chain Rate Alarm Chain A-Fib Alarm Chain Pauses/min Tachy/Brady A-Fib Pause HR High /HR Low Irr Rhythm Run PVCs Couplet R on T Bigeminy Trigeminy Medium Priority chain Pacer not Capture/Pacer not Pacing /Missed Beats PVCs/min Multiform PVC PVC 7.9.
Relearning 7.9.4 Monitoring ECG Understanding the Arrhythmia Display The arrhythmia l area displays: 1. Parameter label 2. PVCs per minute label 3. PVCs per minute value 4. Pauses per minute label 5. Pauses per minute value 1 2 4 5 3 7.10 Relearning Changes in ECG template could result in incorrect arrhythmia alarms and/or inaccurate heart rate. ECG relearning allows the TM80/TM70 to learn new ECG template so as to correct arrhythmia alarms and HR value.
Monitoring ECG 7.10.2 Relearning Manually Initiating an ECG Relearning 1. Tap the QT digital area to enter the [QT/QTc] menu. 2. Tap [Relearn]. OR 1. On the main screen, tap the HR digital area or ECG waveform area to enter the [ECG] menu. 2. In the [ECGParameter Setup] section, tap [Arrhythmia]. 3. Tap [Relearn]. CAUTION • Initiate ECG relearning only during periods of normal rhythm and when the ECG signal is relatively noise-free.
Relearning 7 - 36 Monitoring ECG TM80/TM70 Telemetry Monitor Operator’s Manual
8 Monitoring SpO2 (Optional) Introduction...............................................................................................................8-2 Measurement Limitations.....................................................................................8-2 Safety............................................................................................................................8-3 Connecting the SpO2 Module ............................................................................
Introduction 8.1 Monitoring SpO2 (Optional) Introduction The chapter describes the SpO2 monitoring function, including connecting the SpO2 module, configuring the SpO2, and monitoring the SpO2. For details about the SpO2 parameter setup at the Central Monitoring System, refer to Chapter 12 Monitoring with the TM80/TM70 at the CMS. SpO2 monitoring is a non-invasive technique used to measure the amount of oxygenated hemoglobin and pulse rate by measuring the absorption of selected wavelengths of light.
Monitoring SpO2 (Optional) 8.3 Safety ■ Dysfunctional hemoglobin, methemoglobin (MetHb) ■ Presence of certain dyes, such as methylene and indigo carmine ■ Inappropriate positioning of the SpO2 sensor, or use of incorrect SpO2 sensor ■ Drop of arterial blood flow to immeaurable level caused by shock, anemia, low temperature or vasoconstrictor. such as carboxyhemoglobin (COHb) and Safety WARNING • • • • • • • Only use SpO2 sensors specified in this manual.
Connecting the SpO2 Module 8.4 Monitoring SpO2 (Optional) Connecting the SpO2 Module Connect the SpO2 module to the TM80/TM70. The TM80/TM70 can auto detect the SpO2 module type when the SpO2 module is connected.
Monitoring SpO2 (Optional) Connecting the SpO2 Module SpO2 module SpO2 sensor connector SpO2 sensor Connecting the Nonin SpO2 module TM80/TM70 Telemetry Monitor Operator’s Manual 8-5
Changing the SpO2 Settings Monitoring SpO2 (Optional) SpO2 module SpO2 sensor connector NE CO LL R SpO2 sensor Connecting the Nellcor SpO2 module 8.5 Changing the SpO2 Settings You can change the SpO2 settings from the [SpO2] menu. 8.5.1 Configuring the SpO2 Setup Enter the [SpO2] menu in either of the following ways: 8-6 ■ On the main screen, tap the SpO2 digital area or SpO2 waveform area to enter the [SpO2] menu. ■ In the main menu, tap [Parameter Setup] → [SpO2] to enter the [SpO2] menu.
Monitoring SpO2 (Optional) Changing the SpO2 Settings Options Description Settings* Display PI (Masimo only) Configures whether or not to show the perfusion index (PI) value in the digital area. The perfusion index allows clinicians to assess the pulse strength at the monitoring site for optimal sensor placement. PI gives the numerical value for the pulsatile portion of the measured signal caused by arterial pulsation. PI is an indicator of the pulsatile strength.
Changing the SpO2 Settings Monitoring SpO2 (Optional) Options Description Settings* Averaging (Masimo only) The user-selectable averaging feature allows the clinician to select the desired level of visibility to subtle variations in the measured value. Depending on the patient acuity and area of care, shorter averaging times are sometimes preferred (sleep testing) over longer averaging times (telemetry) and vice-versa.
Monitoring SpO2 (Optional) 8.5.2 Changing the SpO2 Settings Configuring the SpO2 Waveform 1. In the [Waveform] section of the [SpO2] menu, select the options described in the following table. Options Description Settings* Speed Selects the SpO2 pleth waveform speed. 6.25 mm/s, 12.5 mm/s, 25 mm/s Display SIQ (Masimo only) Selects whether or nor to show the Signal Index Quality (SIQ) in the SpO2 waveform area.
Changing the SpO2 Settings Monitoring SpO2 (Optional) Options Description Settings* SpO2 Alarm Setup Configures whether to switch on SpO2 and SpO2 Desat alarms. [SpO2 ] and [Desat] default to be switched on. After tapping [SpO2] or [Desat] you can configure alarm limits and alarm priority. For SpO2: Alarm switch: On, Off Alarm limit range: 0% to 100%; The default alarm upper limit is 100%. The default alarm low limit is 90%.
Monitoring SpO2 (Optional) 8.6 SpO2 Measurement 8.6.1 Identifying SpO2 Modules SpO2 Measurement To identify which SpO2 module you are using, see the company logo on the SpO2 module. 8.6.2 ■ Masimo SpO2 module: purple, with a logo of Masimo SET. ■ Nonin SpO2 module: blue, with a logo of Nonin. ■ Nellcor SpO2 module: grey, with a logo of Nellcor. Applying the Sensor 1. Select an appropriate sensor according to the module type, patient size, and weight. 2.
Understanding the SpO2 Display Monitoring SpO2 (Optional) CAUTION • Many patients suffer from poor peripheral perfusion due to hypothermia, hypovolemia, severe vasoconstriction, reduced cardiac output, etc. These symptoms may cause a loss in vital sign readings. 8.7 Understanding the SpO2 Display 8.7.1 SpO2 Digital Area The SpO2 digital area displays: 1. Parameter name 2. SpO2 value 3. Perfusion indicator 4. Perfusion index (PI) label 5. Perfusion index value 6. SpO2 unit of measure 7.
Monitoring SpO2 (Optional) Understanding the SpO2 Display Nonin SpO2 digital area Nellcor SpO2 digital area 8.7.2 8.7.3 About the SpO2 Digital Area ■ The SpO2 digital area displays in units of % with a resolution of 1%. ■ The SpO2 PR value displays in units of bpm with a resolution of 1 bpm. ■ Displays Masimo PI resolution as 0.01 when the PI value is smaller than 10%. ■ Displays Masimo PI resolution as 0.1 when the PI value is greater than or equal to 10%.
Masimo Information Monitoring SpO2 (Optional) Nonin SpO2 and Nellcor SpO2 waveform area 8.7.4 8.8 About the SpO2 Waveform Area ■ Displays in the configured SpO2 color. ■ Provides scrolling, real-time waveform data. ■ Scrolls the waveform in the configured sweep speed. ■ Automatically scales the SpO2 waveform data area to maximize the vertical height of the Pleth waveform for the data range. ■ If using Masimo SpO2, the Signal Quality Index (SIQ) will display below the waveform if enabled.
Monitoring SpO2 (Optional) 8.9 Nellcor Information Nellcor Information Nellcor Patents This posting serves as notice under 35 U.S.C.§287(a) for Covidien patents: http:// www.covidien.com/patents. No Implied License Possession or purchase of this device does not convey any express or implied license to use the device with unauthorized replacement parts which would, alone, or in combination with this device, fall within the scope of one or more of the patents relating to this device.
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9 Monitoring Resp (Optional) Introduction...............................................................................................................9-2 Resp Safety Information ........................................................................................9-2 Preparing for Resp Monitoring ...........................................................................9-3 Changing Resp Settings ........................................................................................
Introduction 9.1 Monitoring Resp (Optional) Introduction Impedance respiration is measured across the thorax. When the patient is breathing or ventilated, the volume of air changes in the lungs, resulting in impedance changes between the electrodes. Respiration rate (RR) is calculated from these impedance changes, and a respiration waveform appears on the screen. Resp monitoring is intended for adult and pediatric patients. 9.
Monitoring Resp (Optional) 9.3 Preparing for Resp Monitoring 9.3.1 Preparing the Patient Preparing for Resp Monitoring Proper skin preparation is essential in obtaining an accurate ECG reading. Electrode sites should be clean and dry and should provide a smooth flat surface. Incidental electrical activity and inaccurate readings may arise from incorrect skin preparation. The following procedure is recommended for secure electrode application: 9.3.2 1.
Changing Resp Settings Monitoring Resp (Optional) NOTE • • 9.4 Store the electrodes at room temperature. Open the electrode package immediately prior to use. Check that the electrode packages are intact and not expired. Make sure the electrode gel is moist. Changing Resp Settings You can change the Resp settings from the [Resp] menu. 9.4.
Monitoring Resp (Optional) 9.4.2 Changing Resp Settings Configuring the Resp Waveform 1. In the [Waveform] section of the [Resp] menu, select the options described in the following table. Options Description Settings* Gain Selects the Resp waveform size. ×0.25, ×0.5, ×1, ×2, ×3, ×4, ×5 Speed Selects the Resp waveform speed. 3 mm/s, 6.25 mm/s, 12.5 mm/s, 25 mm/s * The factory default settings are in bold. 2. 9.4.3 Press to return to the main screen. Configuring the Resp Alarm Settings 1.
Understanding the Resp Display Monitoring Resp (Optional) 9.5 Understanding the Resp Display 9.5.1 Resp Digital Area The Resp digital area displays: 1. Parameter name 2. Measurement unit 3. Respiration rate (RR) value 4. Alarm high limit and low limit.When RR alarm is switched off, the activation state off icon 9-6 instead of alarm limits is displayed. 1 2 4 3 ■ The Resp area displays respiration rate in the unit of rpm with a resolution of 1 rpm.
Monitoring Resp (Optional) 9.5.2 Understanding the Resp Display Resp Waveform Area The waveform area displays: 1. Parameter name 2. Resp waveform 3. Resp waveform gain 4.
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10 Monitoring NIBP (Optional) Introduction...............................................................................................................10-2 Pairing the TM80/TM70 with the BP10.............................................................10-2 Unpairing the TM80/TM70 with the BP10 ......................................................10-4 Screen Display after Pairing a TM80/TM70 with a BP10 ............................10-5 Interactions after Pairing a TM80/TM70 with a BP10..................
Introduction 10.1 Monitoring NIBP (Optional) Introduction NIBP (non-invasive blood pressure) data is measured by BP10 using the oscillometric method. This measurement can be used for adult and pediatric patients. NIBP data is transferred from the BP10 to the TM80/TM70. You can pair and unpair a TM80/TM70 with a BP10 via the Mindray Patient Area Network (MPAN) functionality.
Monitoring NIBP (Optional) Pairing the TM80/TM70 with the BP10 T. WARNING • Do not pair a TM80/TM70 with an undesired BP10. If a TM80/TM70 is paired with an undesired BP10, the patient category may be not applicable for the patient and the measured NIBP data may be incorrect. NOTE • Make sure that you have selected the correct BP10 to pair it with the TM80/TM70. • 10.2.
Unpairing the TM80/TM70 with the BP10 Monitoring NIBP (Optional) case, follow steps in Pairing the TM80/TM70 with the BP10 on Page 10-2 to pair the TM80/TM70 with the BP10 again. 10.3 ■ When NIBP measurement mode is set to [Manual], [Auto], or [Sequence] and the BP10 is paired successfully with the TM80/TM70, the wireless setup confirmation message “Select Yes to continue Patient in BP10. Select No to continue Patient in Telemetry.” will not be displayed.
Monitoring NIBP (Optional) 10.3.2 Unpairing the TM80/TM70 with the BP10 Unpairing via BP10 1. Press the MPAN key on the BP10. 2. Select [Yes] when the prompt message “Are you sure you want to close MPAN and unpair BP10?” appears. CAUTION • • 10.3.3 Before moving a TM80/TM70 or BP10 to another area, unpair them first. Before admitting a new patient at a BP10, you need to unpair it with a TM80/TM70 first.
Screen Display after Pairing a TM80/TM70 with a BP10 10.4 Monitoring NIBP (Optional) Screen Display after Pairing a TM80/TM70 with a BP10 When a TM80/TM70 is paired with a BP10 successfully, measured NIBP values will be displayed on the main screen of the TM80/TM70 as shown in the following figure. 2 3 4 5 6 7 8 1 11 9 10 10 - 6 1. Systolic pressure alarm limits 2. Systolic pressure 3. Diastolic pressure 4. Diastolic pressure low limit 5. Diastolic pressure high limit 6.
Monitoring NIBP (Optional) Interactions after Pairing a TM80/TM70 with a BP10 10.5 Interactions after Pairing a TM80/TM70 with a BP10 10.5.1 Overview of Interactions Once a TM80/TM70 is paired successfully with a BP10, the interactions proceed as shown below. 10.5.
Interactions after Pairing a TM80/TM70 with a BP10 10.5.3 Monitoring NIBP (Optional) NIBP Operations at the TM80/TM70 In the [Setup] section of the [NIBP] menu at the TM80/TM70, you can: ■ Tap [Mode] to set NIBP measurement mode to one of the following: Manual, Auto, Seq. ABPM. ■ Tap [ABPM] to configure ABPM-related settings: Day, Night, Start, Interval. ■ Tap[ Auto] to set NIBP measurement interval to one of the following: 1 min, 2 min, 2.5 min, 3 min, 5 min, 10 min, 15 min,20 min, 30 min, 1h, 1.
Monitoring NIBP (Optional) Interactions after Pairing a TM80/TM70 with a BP10 Options Description Settings* DIA Configures whether to trigger the NIBP diastolic pressure alarm.
Interactions after Pairing a TM80/TM70 with a BP10 Monitoring NIBP (Optional) Options Description Settings* DIA Extreme Configures whether to trigger the extreme NIBP diastolic pressure alarm.
11 Review Introduction...............................................................................................................11-2 Entering the List Trends Menu ............................................................................11-2 Example List Trends.................................................................................................11-2 Changing the Resolution of Trend Data ..........................................................11-4 Searching Trend Data ..................
Introduction 11.1 Review Introduction Trends are patient data collected over time and displayed in a tabular form to give you a picture of how your patient's condition is developing. You can review the trend data in the [List Trends] menu. 11.2 11.3 Entering the List Trends Menu 1. Press the 2. Tap [Review]. key to enter the main menu. 3. Tap [List Trends]. Example List Trends The latest trend data is displayed in the right most column.
Review Example List Trends 1. Current system date and trend data time. The interval of the trend data time is dependent on the option selected for [Interval]. 2. Event type indicator: different color blocks indicate differnt types of events: ◆ Red: high priority alarm event ◆ Yellow: medium priority alarm event ◆ Cyan: low priority alarm event ◆ Green: manual event ◆ White: operation-related event 3. Highlighted column: indicates the trend data currently selected. 4.
Changing the Resolution of Trend Data ■ Review Example List trends data search screen. This screen is displayed after you tap the button in the List Trends menu. 1 2 11.4 1. Slider: indicates the position of current window time in the entire time length. Dragging the slider left or right enables you to locate the trend data at a specific time and also refreshes trend data in current window accordingly. 2.
Review Searching Trend Data ◆ 11.5 [1 min], [5 min], [10 min], [15 min], [30 min], [1 h], [2 h], [3 h]: select to view up to 48 hours of list trends at selected interval. Searching Trend Data 1. Enter the [List Trends] menu by following steps in "Entering the List Trends Menu" on page 11 - 2. 2. Tap the 3. Drag the button. button to locate the trend data at the desired time length.
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12 Monitoring with the TM80/TM70 at the CMS Introduction...............................................................................................................12-2 Safety............................................................................................................................12-2 Physiological Alarms...............................................................................................12-3 Factory Default Parameter Alarm Settings ..........................................
Introduction 12.1 Monitoring with the TM80/TM70 at the CMS Introduction The chapter describes detailed configurations and data displayed on the BeneVision CMS once the TM80/TM70 are connected to the CMS. When the TM80/TM70 is successfully connected to the CMS, the TM80/TM70 provides the following functions. 12.2 ■ The TM80/TM70 can transmits parameter values, waveforms, alarm settings, and events to the CMS. From the CMS, you can check the patient’s monitoring data and alarms.
Monitoring with the TM80/TM70 at the CMS 12.3 Physiological Alarms Physiological Alarms At the CMS, you can view and change the physiological alarm limits and alarm levels in the [Alarm Setup] menu. For details on how enter the [Alarm Setup] menu, see BeneVision Central Monitoring System Operator’s Manual (P/N 046-007960-00). WARNING • • • • • • 12.4 Be aware that the devices in your care area may each have different alarm settings to suit different patients.
Factory Default Parameter Alarm Settings Parameters Activati on State Monitoring with the TM80/TM70 at the CMS Alarm High Limit Alarm Low Limit Alarm Priority HR/PR Unit of measure: bpm Invalid data: “--” On, Off For adult: (Low limit + 2) to 300 Default: 120 For pediatric: (Low limit + 2) to 350) Default: 160 For adult: 15 to (high limit - 2) Default: 50 For pediatric: 15 to (high limit - 2) Default: 75 High, Med ST Single Unit of measure: mV Invalid data: “--” On, Off For adult and pediatric
Monitoring with the TM80/TM70 at the CMS Parameters Activati on State SpO2 On, Off Factory Default Parameter Alarm Settings Alarm High Limit Alarm Low Limit Alarm Priority For adult and pediatric: (Low limit + 2) to 100 Default: 100 For adult and pediatric: 0 to (high limit - 2) Default: 90 High, Med For adult and pediatric: None For adult and pediatric: 0 to 100 Default: 80 High NIBP-S Unit of measure: mmHg Invalid data: “---” For adult: (Low limit + 5) to 270 Default: 160 For adult: 40 to
Factory Default Arrhythmia Alarm Settings 12.
Monitoring with the TM80/TM70 at the CMS Factory Default Arrhythmia Alarm Settings Name Activation State Alarm Priority Alarm Outputs Missed Beats On, Off High, Med, Low, Prompt On, Off Multiform PVC High, Med, Low, Prompt Nonsus V-Tac Pause High, Med, Low, Prompt A-Fib High, Med, Low, Prompt Irr Rhythm Low, Prompt Pauses/min High, Med, Low, Message Notes The factory default settings are in bold.
Arrhythmia Threshold Settings 12.6 Monitoring with the TM80/TM70 at the CMS Arrhythmia Threshold Settings When an arrhythmia violates its threshold, an alarm is triggered. When HR is less than 30 bpm, it is recommended to set asystole delay to 10 s. Arrh.
Monitoring with the TM80/TM70 at the CMS 12.7.1 ECG Monitoring Changing ECG Alarm Properties 1. From the [ECG] tab, select the [Alarm] section. 2. Set the desired alarm properties. For the default alarm properties, See "Factory Default Parameter Alarm Settings" on page 12 - 3. 12.7.2 Changing ECG Wave Settings 1. From the [ECG] tab, select the [Setup] section. 2. Set the desired items.
ECG Monitoring 12.7.3 Monitoring with the TM80/TM70 at the CMS Changing Pacer Settings 1. From the [ECG] tab, select the [Pacer] section. 2. Set the desired items. Options or Buttons Description Default Setting Paced The option is not configurable at the CMS. The paced status can be set at the TM80/ TM70 only. See "Checking the Paced Status" on page 7 - 11 for details. None Pacer Reject Configures whether or not to reject the pace pulses.
Monitoring with the TM80/TM70 at the CMS 12.7.5 ECG Monitoring ECG Display ECG Digital Area The ECG digital area displays: 1. HR unit 2. Parameter label 3. HR value 4. Low HR alarm limit 5. High HR alarm limit 2 1 3 5 4 ECG digital area NOTE • If an alarm for a parameter is disabled, the symbol is displayed on the right of this parameter. ECG Waveform Area The ECG waveform area displays: 1. ECG Lead 2. ECG waveform size 3. ECG filter setting 4. Notch filter setting 5.
QT Monitoring Monitoring with the TM80/TM70 at the CMS 1 3 2 4 5 6 12.8 QT Monitoring A normal ECG waveform (as shown in the following figure) typically includes a sharp and well defined QRS complexes with consistent spacing between R waves, and an ECG baseline that is free of noise and artifact.
Monitoring with the TM80/TM70 at the CMS 12.8.2 QT Monitoring Entering the QT Tab To enter the [QT] tab, follow this procedure: 12.8.3 1. Select the ECG digital area or waveform area to enter the [ECG] menu on the ViewBed screen of the CMS. 2. Select the [QT] tab. Changing QT Alarm Properties To set QT alarm properties, follow this procedure: 1. From the [QT] tab, select the [Alarm] section. 2. Set the desired alarm properties.
QT Monitoring Monitoring with the TM80/TM70 at the CMS ■ The template waveform and parameter values display in white. ■ The Q and T points are marked with a vertical line. ■ The ΔQTc value is equal to the current QTc value minus the template QTc value. ■ In some conditions, no QT measurement can be calculated. Then the cause of failed QT measurement is shown at the bottom of the QT digital area and the message “Cannot Analyze QT” is shown in the technical alarm area.
Monitoring with the TM80/TM70 at the CMS 12.8.6 ST Monitoring QT Display When [QT Analysis] is enabled, the QT digital area displays: 1. Parameter label 2. QTc value 3. ΔQTc value 4. QT value 5. QTc alarm limit (if QTc alarm is off, the alarm off symbol is displayed) 3 2 1 5 4 NOTE • 12.9 The display of the QT digital area differs as related settings change.
ST Monitoring Monitoring with the TM80/TM70 at the CMS The ST segment of an ECG waveform (as shown in the above figure) represents the period from the end of ventricular de-polarization, to the beginning of ventricular repolarization, or the end of the QRS complex (the J point) and the beginning of the Twave. ST Segment analysis is used to monitor the oxygen supply and the viability of the heart muscle.
Monitoring with the TM80/TM70 at the CMS 12.9.2 12.9.3 ST Monitoring Entering the ST Tab 1. Select the ECG digital area or waveform area to enter the [ECG] menu on the ViewBed screen of the CMS. 2. Select the [ST] tab. Changing ST Alarm Properties 1. From the [ST] tab, select the [Alarm] section. 2. Set the desired alarm properties. For the default alarm properties, See "Factory Default Parameter Alarm Settings" on page 12 - 3. 12.9.4 Changing ST Settings 1.
ST Monitoring 12.9.5 Monitoring with the TM80/TM70 at the CMS Adjusting ST Measurement Points The ISO and ST points need to be adjusted when you start monitoring and if the patient’s heart rate or ECG morphology changes significantly. Exceptional QRS complexes are not considered for ST-segment analysis. WARNING • Always make sure that the ST measurement points are appropriate for your patient. To adjust ST measurement points, follow this procedure. 1. 12.9.
Monitoring with the TM80/TM70 at the CMS ST Monitoring The height of grey bar indicates the baseline ST value and the green bar (cyan, yellow or red if an alarm occurs) indicates ΔST. 12.9.7 Entering the ST View The ST View shows a complete QRS segment for each ST lead. The color of current ST segments and ST values is consistent with the color of ECG waveforms, normally green. The color of baseline ST segments and ST values is white. To enter the ST View, follow this procedure: 1.
ST Monitoring 4. Monitoring with the TM80/TM70 at the CMS Set the desired items. Buttons Description Settings* Set Baseline Set an ST baseline when ST values become stable. None The QT template updated time displays at the bottom of the screen. Display/Hide Baseline Displays or hides the reference baseline. Display/Hide Marker Displays or hides the position of ISO point, J point and ST point. 12.9.8 None ST Display When [ST Analysis] is enabled, the ST digital area displays: 1.
Monitoring with the TM80/TM70 at the CMS 4. Baseline ST value 5. ST unit 1 2 5 Arrhythmia Monitoring 3 4 5-lead ST segments 12.10 Arrhythmia Monitoring 12.10.1 Entering the Arrhythmia Tab To enter the [Arrhythmia] tab, follow this procedure: 1. Select the ECG digital area or waveform area to enter the [ECG] menu on the ViewBed screen of the CMS. 2. Select the [Arrhythmia] tab. 12.10.
Arrhythmia Monitoring Monitoring with the TM80/TM70 at the CMS 12.10.3 Understanding the Arrhythmia Events For description about arrhythmia events, see "Arrhythmia Events" on page 7 - 25. 12.10.4 Setting Arrhythmia Alarm Properties 1. From the [Arrhythmia] tab, select the [Alarm] section. 2. Set the desired alarm properties. For the default alarm properties, See "Factory Default Parameter Alarm Settings" on page 12 - 3. 12.10.
Monitoring with the TM80/TM70 at the CMS Arrhythmia Monitoring If both V-Tach PVCs and V-Tach Rate are greater than or equal to the limits, a V-Tach alarm is generated. ■ If consecutive PVCs is lower than the V-Tach PVCs limit (6) but greater than 2, and the Vent rate is greater or equal to the V-Tach Rate limit (130), a Nonsus V-Tach alarm is generated.
Resp Monitoring Monitoring with the TM80/TM70 at the CMS 12.10.8 Arrhythmia Display When [Arrhythmia] is selected to display in the [Tile Layout], the arrhythmia digital area displays: 1. Parameter label 2. Measurement unit 3. Arrhythmia alarm off symbol 4. PVCs per minute label 5. Pauses per minute label 6. PVCs per minute value 7. Pauses per minute value 1 2 7 3 4 6 5 12.10.9 Relearning For details about relearning, see "Relearning" on page 7 - 34. 12.
Monitoring with the TM80/TM70 at the CMS Resp Monitoring 12.11.1 Changing Resp Alarm Properties 1. In the [Resp] menu, select the [Alarm] tab and [PR Alarm] tab respectively. 2. Set the desired alarm properties. For the default alarm properties, See "Factory Default Parameter Alarm Settings" on page 12 - 3 . 12.11.2 Changing Resp Settings 1. In the [Resp] menu, select the [Setup] tab. 2. Set the desired items. Options Description Default Setting Gain Configures the Resp waveform size.
SpO2 Monitoring Monitoring with the TM80/TM70 at the CMS 1 2 6 5 4 3 Resp Waveform Area The Resp waveform area displays: 1. Parameter label 2. Resp size 3. Resp waveform 4. Resp lead 1 2 3 4 12.12 SpO2 Monitoring At the CMS, you can view and change the SpO2 settings in the [SpO2] menu. Select the SpO2 digital area or waveform area on the ViewBed screen of the CMS to enter the [SpO2] menu. 12.12.1 Measurement Limitations See "Measurement Limitations" on page 8 - 2 for details.
Monitoring with the TM80/TM70 at the CMS SpO2 Monitoring 12.12.2 Changing SpO2 Alarm Properties To change ECG alarm properties, follow this procedure: 1. In the [SpO2] menu, select the [Alarm] tab and [PR Alarm] tab respectively. 2. Set the desired alarm properties. For the default alarm properties, See."Factory Default Parameter Alarm Settings" on page 12 - 3. 12.12.3 Changing SpO2 Settings 1. In the [SpO2] menu, select the [SpO2 Setup] tab. 2. Set the desired items.
SpO2 Monitoring Monitoring with the TM80/TM70 at the CMS 10. Low SpO2 alarm limit 11. SpO2 value 3 2 1 4 8 7 5 6 Masimo SpO2 digital area Nonin Spo2 digital area Nellcor SpO2 digital area 12.12.5 SpO2 Waveform Area The SpO2 waveform area displays: 1. Parameter label 2.
Monitoring with the TM80/TM70 at the CMS NIBP Monitoring 12.13 NIBP Monitoring At the CMS, you can view and change NIBP settings in the [NIBP] menu. Select the NIBP digital area on the ViewBed screen of the CMS to enter the [NIBP] menu. 12.13.1 Measurement Limitations See BP10 NIBP Module Operator’s Manual (P/N 046-011008-00) for details. 12.13.2 Changing NIBP Alarm Properties 1. In the [NIBP] menu, select the [Alarm] tab. 2. Set the desired alarm properties.
Locating the TM80/TM70 Monitoring with the TM80/TM70 at the CMS 2 3 4 1 5 6 10 9 8 7 12.13.5 NIBP List When[NIBP List] is selected to display in the [Tile Layout], the NIBP list area displays multiple sets of most recent NIBP measurements. The displayed PR is derived from NIBP. NOTE • NIBP List cannot be displayed on some screens such as the big numerics screen. 12.
Monitoring with the TM80/TM70 at the CMS Locating the TM80/TM70 NOTE • Find Device requires that the TM80/TM70 has sufficient battery power and is within the coverage area.
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13 Configuring the TM80/TM70 Introduction...............................................................................................................13-2 Maintenance Menu .................................................................................................
Introduction 13.1 Configuring the TM80/TM70 Introduction The [Maintenance] menu provides access to the system settings such as location, device name, alarm settings, quick keys, screen lock, and password updates. Entering this menu requires a passcode. 13.2 Maintenance Menu The [Maintenance] menu contains the following submenus: 13.2.1 13.2.
Configuring the TM80/TM70 Maintenance Menu Options Description Settings* Display Auto Off Configures the time for display auto off. 1 min, 2 min, 5 min, 15 min 30 min, Off Language Configures the system language. ENGLISH, FRENCH Device Location Changes the hospital ,department name, room number, and bed number. Refer to "Configuring Device Location" on page 13 - 4 for details. N/A Notch Filter Configures the ECG Notch filter.
Maintenance Menu 13.2.2.1 Configuring the TM80/TM70 Configuring Device Location You can change the hospital name and set whether to allow modifying a department name, room number, and bed number in the [Patient Info] menu. To do so, follow this procedure: 1. In the [Maintenance] menu, tap [General]. 2. Tap [Device Location]. 3. Tap [Facility]. 4. Enter the desired name. 5. Tap [Department ]. 6. Select the desired option. ◆ [Fixed]: you cannot modify [Department] in the [Patient Info] menu.
Configuring the TM80/TM70 Section & Options Maintenance Menu Description Settings* Style Allows an authorized user to set the alarm tone pattern. ISO, Mode 1, Mode 2 Minimum Alarm Volume Allows an authorized user to configure the minimum alarm volume. The minimum alarm volume defines the minimum value you can set for the alarm volume.
Maintenance Menu Configuring the TM80/TM70 WARNING • • When [Minimum Alarm Volume] is set to [Off] and [Sounds] is set to 0, alarm sound is turned off, the TM80/TM70 will not enunciate alarms when they occur. Be careful when turning off the alarm sound. Do not rely exclusively on the audible alarm system for monitoring. Adjustment of alarm volume to a low level may result in a hazard to the patient. Always keep the patient under close surveillance. 13.2.4 Quick Keys Menu 13.2.4.
Configuring the TM80/TM70 Maintenance Menu A list of options 13.2.4.2 3. Tap the desired option from the list of options to configure the selected quick key. 4. Repeat steps 2 to 3 to configure other quick keys, if needed. 5. Tap to exit the [Quick Keys] menu. Deleting a Quick Key 1. From the quick keys area at the bottom of the [Quick Keys] menu, press and hold the desired quick key for two seconds, and then release it. The quick key background turns to red and displays [Delete]. 2.
Maintenance Menu Configuring the TM80/TM70 Options Action Description Applicable model IP Address Setup Select to access the IP Setting menu. Refer to "Configuring IP Settings" on page 13 - 8 for details. TM80 WLAN Setup Select to access the WLAN Setting menu. Refer to "Configuring WLAN Settings" on page 13 - 9 for details. TM80 Connect CMS Select to access the Connect CMS menu. TM80&TM70 Wireless Setup Select the desired wireless band.
Configuring the TM80/TM70 Maintenance Menu Options Description Settings* DHCP Allows an authorized user to select the way to get the IP address. When enabled, the IP address is automatically assigned. On, Off The following three options are only enabled when [DHCP] is set to Off. IP Address Select to input the IP address. Range: 1 to 255 Factory default: 192.168.0.100 Subnet Mask Select to input the subnet mask. Range: 1 to 255 Factory default: 255.255.255.
Maintenance Menu 3. Configuring the TM80/TM70 Tap [Confirm] to apply the settings and exit the [WLAN Setup] menu. NOTE • • 13.2.5.3 We recommend that the latest WPA2-PSK security encryption mode be used when the TM80 is in use. It provides a strong method of security when used with rotating strong passwords. Besides, it can provide optimal mobility and connectivity performance. WPA/WPA2 EAP may be used but should be carefully considered, because it may TM80 roam more slowly.
Configuring the TM80/TM70 Maintenance Menu 1. In the [Network] menu, tap [Connect CMS]. 2. Tap [Connection Mode] . 3. Select [Unicast]. 4. Configure the desired options. . Options Description Settings* Edit CMS Configure the name and IP of the CMS you want to connect. / Select CMS Select the CMS you want to connect. / QOS Configure the quality of service mode for the wireless network. High, Normal * The factory default settings are in bold. 5. 13.2.5.
Maintenance Menu 13.2.5.6 Configuring the TM80/TM70 EAP Certificate Management You can import up to 10 certificates from a USB drive or delete certificates from the TM80. Importing Certificates 1. Insert a USB drive to the USB port of your computer. 2. Create the folder named “Cert” in the USB drive. 3. Copy the desired certificates to the “Cert” folder. 4. Remove the battery for the TM80’s battery compartment and find the MicroUSB socket inside the battery compartment. 5.
Configuring the TM80/TM70 Maintenance Menu Options Description Export Device Settings Copies the current settings to the external device. Import Device Settings Copies the settings from the external device to the TM80/TM70 unit. Refer to "Transferring a Configuration" on page 13 - 13 for details. Restore Factory Defaults Allows an authorized user to reestablish the original database power up settings to factory default values. * The factory default settings are in bold. 3. 13.2.
Maintenance Menu Configuring the TM80/TM70 menu. On the TM80/TM70, the status for the external device will display the “Complete” message. ■ On the external device if the import fails, the external device will display the “Import attempt failed.” message. On the TM80/TM70, the status for the failed external device will display the “Failure” message and remain in the list. The user has two options when a failure occurs: ◆ To stop the import from the external device, tap the [Import Device Settings].
Configuring the TM80/TM70 13.2.8.2 Maintenance Menu Setting the Screen Lock The initial enabling of screen lock mode requires a passcode to be entered immediately as follows: 1. In the [Maintenance] menu, tap [Screen Lock] to select a screen lock mode. 2. Enter a new passcode for the screen lock. After the passcode is entered, the screen exits the passcode setup menu. The selected lock mode displays to the right of [Screen Lock]. 13.2.8.3 13.2.9 Changing the Current Screen Lock Passcode 1.
Setting CMS Disconnect Alarm 13.3 Configuring the TM80/TM70 Setting CMS Disconnect Alarm In the [Maintenance] menu, you can set whether to enable [CMS Disconnect Alarm] This option is enabled by default. ■ When it is enabled, after the TM80/TM70 is disconnected from the CMS: ■ ◆ The TM80/TM70’s display is turned on automatically. ◆ The TM80/TM70 issues a low-pitched beep, its alarm light indicator flashes in cyan, and the “No CMS” message is displayed in the prompt message area of the TM80/TM70.
Configuring the TM80/TM70 Configuring WMTS Setting Options Description Settings* AP Code Select the AP Code of the AP TM70 connects to. AP Code is the unique attribute of an AP. 0,1,2,3,4,5,6,7 WMTS AP Band Select the WMTS AP band TM70 works on. Auto,1.4G Wide, 608M, 1.4G Narrow * The factory default settings are in bold.
Configuring WMTS Setting 13 - 18 Configuring the TM80/TM70 TM80/TM70 Telemetry Monitor Operator’s Manual
14 Battery Introduction...............................................................................................................14-2 Safety............................................................................................................................14-2 Installing the Battery ..............................................................................................14-3 Checking the Battery Charge Status .................................................................
Introduction 14.1 Battery Introduction The TM80/TM70 can be powered by a lithium-ion rechargeable battery or AA batteries. This chapter provides instructions on how to use, maintain, and dispose of the batteries. 14.2 Safety SE WARNING • • • • • • • • • 14 - 2 Keep the batteries out of children’s reach. Keep the batteries in their original package until you are ready to use them. Do install the lithium-ion battery pack or the AA battery frame to close the battery compartment during defibrillation.
Battery Installing the Battery WARNING • • • • • The rechargeable lithium-ion batteries should be charged in the specified central charger. If a battery shows signs of damage or signs of leakage, replace it immediately. Use caution in removing the battery. Avoid contact with skin. Refer to qualified service personnel. Some failure conditions, such as short circuits, can cause a battery to overheat during using. High temperature can cause burns to the patient or user.
Checking the Battery Charge Status 14.4 Battery Checking the Battery Charge Status The battery symbol displaying on the top of main screen indicates the battery charge status. The white part ( ) indicates the remaining battery charge. NOTE • 14.5 If the “Low Battery” or “Critically Low Battery” alarm occurs, the TM80/ TM70 turns off the audio, the screen display the “Local Audio Off” message, and the screen brightness turns dimmer.
Battery Charging the Rechargeable Lithium-ion Battery 2. 14.6 Remove the lithium-ion battery pack or AA battery tray from the TM80/TM70. Charging the Rechargeable Lithium-ion Battery WARNING • • • • • • Only use the specified central charger to charge to the lithium-ion batteries designated by Mindray. Only use the approved power cord with the grounded mains plug to firmly connect the central charger to a grounded AC mains socket. Never refit the mains plug to fit an ungrounded AC mains socket.
Storing the Batteries Battery 14.7 Storing the Batteries 14.7.1 Storing Rechargeable Lithium-ion Battery When storing batteries, make sure that the battery terminals do not come into contact with metallic objects. If you need to store the batteries for an extended period of time, place the batteries in a cool, dry place (ideally at 15°C or 60°F) with a partial charge of about 50% capacity (two LEDs illuminated). Storing batteries in a cool place can slow the aging process.
Battery Maintaining the Rechargeable Lithium-ion Battery NOTE • 14.8 Replace the AA battery frame on the battery compartment after removing the AA batteries. Maintaining the Rechargeable Lithium-ion Battery Take care of the rechargeable lithium-ion battery once you receive a new battery for use. The following table describes the battery maintenance activities and recommended frequency. Activity Recommended Frequency Visual inspection Before installing a battery in the TM80/TM70.
Disposing of the Batteries Battery NOTE • The battery capacity degrades as using time and number of recharge cycles.Toward the end of its useful life, the battery capacity may be reduced by 20% to 25%. If the reduced battery life is unacceptable for your device, Mindray recommends the battery be replaced. 14.9 Disposing of the Batteries 14.9.1 Disposing of the Rechargeable Lithium-ion Battery Discard the lithium-ion battery in the following situations: ■ The battery has visual signs of damage.
15 Troubleshooting General Problems ....................................................................................................15-2 Physiological Alarm Messages at the TM80/TM70.......................................15-2 Technical Alarm Messages at the TM80/TM70 ..............................................
General Problems 15.1 Troubleshooting General Problems The following table lists the problems that are likely to occur. If the problem persists after corrective actions have been taken, contact your service personnel. Symptom Possible cause Solution ECG Signal Saturated The TM80/TM70 detected ECG signal saturation or overload. Check the ECG leadwires. Check if the electrodes are in good contact with the skin. 15.
Troubleshooting Physiological Alarm Messages at the TM80/TM70 Measurement Alarm message Alarm level Possible cause Solution ECG Asystole High The patient is in arrhythmia. Check the patient’s condition and the ECG connections. The pacer appears abnormal. Check the pacer. V-Fib/V-Tac V-Tac Vent Brady Extreme Tachy Extreme Brady R on T Med* Run PVCs Low* Couplet Message* Multif.
Physiological Alarm Messages at the TM80/TM70 Troubleshooting Measurement Alarm message Alarm level Possible cause Solution Resp RR Too High Medium* RR value has risen above the high alarm limit or fallen below the low alarm limit. Check the patient’s condition and make sure that the patient category and alarm limit settings are correct. High The respiration signal was so weak that the monitor cannot perform respiration analysis. Check the patient’s condition, module and patient connections.
Troubleshooting Technical Alarm Messages at the TM80/TM70 Measurement Alarm message Alarm level Possible cause Solution NIBP NIBP-Sys Extremely High High The NIBP systolic pressure has risen above the SYS Desat alarm high limit or fallen below the SYS Desat alarm low limit. Check the patient’s condition and check if the alarm limit settings are correct. NIBP-Sys Extremely Low NIBP-Mean Extremely High NIBP-Mean Extremely Low NIBP-Dia Extremely High NIBP-Dia Extremely Low * 15.
Technical Alarm Messages at the TM80/TM70 Measurement ECG Alarm message Alarm level Alarm Indication ECG Lead Off Low* B ECG XX** Lead Off Low* B ECG Module Error High A Troubleshooting Possible cause Solution The electrode has become detached from the patient or the lead wire has become disconnected from the adapter cable. Check the connections of the electrodes and leadwires. An error occurred to the ECG module. Restart the TM80/ TM70.
Troubleshooting Measurement SpO2 NIBP Technical Alarm Messages at the TM80/TM70 Alarm message Alarm level Alarm Indication SpO2 Sensor Off Low* B SpO2 Sensor Fault Low C SpO2 No Sensor Low B SpO2 Module Error High A SpO2 Too Much Light Low A There is too much light on the SpO2 sensor. Move the sensor to a place with lower level of ambient light or cover the sensor to minimize the ambient light. SpO2 No Pulse Low A SpO2 sensor failed to obtain pulse signal.
Technical Alarm Messages at the TM80/TM70 Measurement NIBP Alarm message Alarm level Alarm Indication Possible cause Solution NIBP Error High A ■ An error occurred to the NIBP module. Restart the BP10. ■ There is a problem w i t h co mm u n i c at i o n between the TM80/TM70 and BP10. ■ The NIBP cuff is not properly connected. ■ There is a leak in the airway. NIBP Cuff Loose Low C 1. Check the patient's condition and verify patient category. 2.
Troubleshooting Measurement NIBP Technical Alarm Messages at the TM80/TM70 Alarm message Alarm level Alarm Indication NIBP Cuff or Airway Leak Low C NIBP Timeout Low C Possible cause Solution The NIBP airway may leak air. 1. Verify that the cuff is properly connected. 2. 2. Verify that the airway does not leak air. 1. Check the patient’s condition and NIBP connections. 2. Replace the cuff. 1. Check the patient’s category. 2. Replace the cuff. ■ Time is out.
Technical Alarm Messages at the TM80/TM70 Measurement Power System Troubleshooting Alarm message Alarm level Alarm Indication Possible cause Solution Low Battery Medium A The battery charge is low. Replace with new batteries. Critically Low Battery High A The battery charge is almost depleted. Battery Maintenance Required Medium A The lithium-ion battery is aging. Battery Error Medium A The lithium-ion battery communication is error.
16 Cleaning and Disinfecting Introduction...............................................................................................................16-2 Safety Information...................................................................................................16-2 Cleaning the TM80/TM70......................................................................................16-3 Cleaning the Reusable ECG Leadwires, SpO2 Modules and Sensors ....16-4 Cleaning the Battery and Battery Compartment ..
Introduction 16.1 Cleaning and Disinfecting Introduction Only use the substances approved by Mindray and methods listed in this chapter to clean or disinfect your device. Our warranty does not cover damage caused by unapproved substances or methods. Mindray makes no claims regarding the efficacy of the listed chemicals or methods as a means for controlling infection. For the method to control infection, consult your hospital’s Infection Control Officer or Epidemiologist. 16.
Cleaning and Disinfecting Cleaning the TM80/TM70 CAUTION • • • 16.3 If liquid has accidentally entered the equipment or its parts, shut down the equipment and have the device serviced by authorized service personnel. Remove the equipment from use if liquid is spilled on the equipment or accessories. Contact your service personnel. When cleaning, avoid the ECG leadwire connector and other connectors. Cleaning the TM80/TM70 CAUTION • Only use the following approved cleaning solutions.
Cleaning the Reusable ECG Leadwires, SpO2 Modules and Sensors Cleaning and Disinfecting To clean your TM80/TM70, follow this procedure: 16.4 1. Shut down the equipment. 2. Dilute the mild soap in water to make a cleaning solution. 3. Soak a clean and soft cloth in the solution and wring out excess solution. 4. Thoroughly wipe the display screen and the exterior surface of the equipment with the damp cloth, avoiding the connectors. 5.
Cleaning and Disinfecting Cleaning the Battery and Battery Compartment CAUTION • • • Clean the cables carefully to avoid breaking internal wires by excessive bending, strain, or flexing. Do not autoclave, radiation or steam sterilize the cables and sensors. Extended exposure to Ethylene Oxide gas may shorten life of the cables, leading to poor signal quality. NOTE • 16.5 Refer to the individual instruction sheets that are packaged with the accessories for additional information.
Disinfection 16.6 Cleaning and Disinfecting Disinfection Disinfect the TM80/TM70 and accessories as required in your hospital’s servicing schedule. Cleaning before disinfection is recommended. Refer to the instructions for use delivered with the accessory to disinfect reusable ECG leadwires and SpO2 sensors. The following table lists recommended disinfectants for disinfecting the TM80/TM70.
Cleaning and Disinfecting Disinfection Product Name Product Type Active Ingredients Alpet® D2 Surface Sanitizing Wipes Wipes Isopropyl Alcohol 58.6000%? Octyl Decyl Dimethyl Ammonium chloride 0.0075%, Dioctyl Dimethyl Ammonium Chloride 0.0030% Clorox Dispatch® Hospital Cleaner Disinfectant Towels with Bleach Sodium Hypochlorite 0.65% Clorox Healthcare® Bleach Germicidal Wipes Sodium Hypochlorite 0.55% Clorox Healthcare® Hydrogen Peroxide Cleaner Disinfectant Wipes Hydrogen Peroxide 1.
Sterilization 16.7 Cleaning and Disinfecting Sterilization Sterilization is not recommended for this equipment, related products, accessories or supplies unless otherwise indicated in the Operating Instructions that accompany the accessories or supplies.
17 Maintenance Introduction...............................................................................................................17-2 Safety............................................................................................................................17-2 Regular Check ...........................................................................................................17-3 Maintenance and Testing Schedule ..................................................................
Introduction 17.1 Maintenance Introduction The chapter outlines the routine maintenance guidelines. The TM80/TM70 is designed for stable operation over long periods of time. Under normal circumstances, the devices should not require technical maintenance beyond that described in this chapter. However, routine maintenance, calibration and safety checks are recommended at least once a year or more often as required by local statutory or hospital administration practice. 17.
Maintenance 17.3 Regular Check Regular Check Perform a visual inspection before the equipment is first used every day. Verify that the equipment meets the following requirements: ■ The housing and display screen are free from cracks or other damages. ■ All keys funtion properly. ■ Connectors are not loose, cracked, or bent and cables have no cuts, nicks, or fraying. ■ ECG leadwires are securely connected with the equipment ■ Battery pack is installed and has sufficient charge.
Maintenance and Testing Schedule 17.4 Maintenance Maintenance and Testing Schedule The following maintenance and tests, except for visual inspection, power on test, and battery check, shall be carried out by the service personnel only. Contact your service personnel if any maintenance is required. Make sure to clean and disinfect the equipment before any test and maintenance. Check/Maintenance Item Recommended Frequency Visual inspection When first installed or reinstalled.
Maintenance 17.6 Verifying the ECG Verifying the ECG The ECG signal may be inaccurate due to hardware or software problems. As a result, the ECG wave amplitude becomes greater or smaller. To verify the ECG waveform amplitude: 1. In the main menu, tap [Maintenance]. 2. Input the maintenance passcode. 3. Tap [Accept]. 4. In the [Maintenance] menu, tap [General]. 5. Enable [Calibrate ECG]. A square wave appears on the screen and the message [ECG Calibrating] is displayed. 17.6.1 6.
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18 Accessories ECG Accessories........................................................................................................18-2 SpO2 Accessories .....................................................................................................18-4 Miscellaneous............................................................................................................18-6 NIBP Accessories ......................................................................................................
ECG Accessories Accessories The accessories listed in this chapter comply with the requirements of IEC 60601-1-2 when in use with the device. The accessory material that contacts the patients has undertaken the bio-compatibility test and is verified to be in compliance with ISO 10993-1. For details about the accessories, refer to the instructions for use provided with the accessory. WARNING • • • • • Use accessories specified in this chapter.
Accessories 18.1.
SpO2 Accessories 18.2 Accessories SpO2 Accessories The SpO2 sensor material that contacts patients or other staff has undertaken the biocompatibility test and is verified to be in compliance with ISO 10993-1. 18.2.1 Masimo SpO2 Module PN Description Applicable property Applicable patient 009-004936-00 Masimo SpO2 module (SET uSpO2) Reusable Adult, Pediatric Applicable property Applicable patient Disposable Adult 18.2.
Accessories 18.2.3 SpO2 Accessories Nonin SpO2 Module PN Description Applicable property Applicable patient 009-004935-00 Nonin SpO2 module (XPOD 3012LP) Reusable Adult, Pediatric 18.2.4 Nonin SpO2 Sensor PN Description Applicable property Applicable patient 0600-00-0139-24 Sensor, SpO2 (Nonin), Disp (24) Disposable Adult 100-000077-00 Nonin 8000AA Reusable SpO2 Sensor Reusable 100-000134-00 standard pediatric clip sensor Reusable 100-000135-00 pediatric disp.
Miscellaneous 18.3 Accessories Miscellaneous PN Description 022-000196-00 Li-ion battery 3.8V 3800mAh 0000-10-10902 Alkaline 1.5 V AA battery 0146-00-0077-10 L91 AA battery 045-001699-00 TP-3AA battery frame 048-005247-00 Disposable pouch 048-005246-00 Reusable pouch DA8K-10-14452 US power cord 009-005409-00 USB upgrade cable 115-026852-00 Main unit of the charger 18.4 NIBP Accessories Refer to BP10 NIBP Module Operator’s Manual (P/N 046-008269-00) for accessories for BP10 modules.
A Product Specifications Classifications............................................................................................................A-2 Environmental Specifications..............................................................................A-2 Power Supply Specifications................................................................................A-3 Physical Specifications ...........................................................................................
Classifications Product Specifications This chapter provides specifications of the TM80, TM70, AP70, SYNC70and central charger, For specifications of BP10, refer to BP10 NIBP Module Operator’s Manual (P/N 046008269-00). A.1 Classifications The device is classified as follows according to IEC60601-1: Type of protection against electrical shock TM80/TM70: Class I, energized from an internal electrical power source. Central Charger: Class I. AP70: Class II. SYNC70: Class I.
Product Specifications Power Supply Specifications Item Operating conditions Storage conditions Temperature 0 °C to 40 °C -20 °C to 60 °C Relative humidity (noncondensing) 15% to 95% 10% to 95% Barometric 427.5 mmHg to 805.5 mmHg, or 57.0 kPa to 107.4 kPa 120 mmHg to 805.5 mmHg, or 16.0 kPa to 107.4 kPa A.3 Power Supply Specifications A.3.1 TM80/TM70 The TM80/TM70 is powered by batteries.
Physical Specifications A.3.2 Product Specifications Central Charger The central charger is powered by external AC power. Input voltage 100 VAC to 240 VAC (± 10%) Frequency 50 Hz/60 Hz (±3 Hz) Input current 1.5 A to 0.75 A Charge time At the room temperature: ≤ 5 hours to 90% charge Overcharge protection function The charger automatically stops charging when the lithium-ion battery charge is full. A.
Product Specifications Display Activation (Power On/Off) key Hardware Specifications The switch time is less than or equal to two seconds. LED 1 (three colors: red, yellow, and cyan) Alarm lamp Audio Indicator Speaker 1 Sound Pressure Range 45 dBA to 85 dBA Keys Nurse call 1 Power On/Off 1 Main menu 1 External Connectors ECG connector 1 SpO2 connector 1 A.5.
Hardware Specifications Product Specifications 1micro USB port, USB2.0 standard USB port Button Reset button A.5.3 1 AC70 System requirements for computers running AC70 management software: Hardware ≥1T Network port 1 Network adapter ≥1GB CPU ≥2.1GHz,; ≥6 cores Memory ≥ 12GB Operating system windows 10 or windows server 2016 A.5.
Product Specifications AC power input port Wireless Specification 1,supporting voltage input:100~240VAC(±10%),frequency input: 50Hz(±3Hz) or 60Hz(±3Hz) Button Reset button A.5.5 1 Central Charger Charger slot 10 LED 10, which indicates the battery charge status. AC power indicator 1 Installation mode Place on the desktop, or mount on GCX® wall channel. A.6 Wireless Specification A.6.1 TM80 wifi specification A.6.1.1 Technical Specifications Protocol IEEE 802.
Wireless Specification Product Specifications IEEE 802.11b: 1~11M Mbps IEEE 802.11a/g: 6~54M Mbps IEEE 802.11n: MCS0~7 IEEE 802.11ac: MCS0~8 Wireless baud rate Output power < 20 dBm (CE requirement: detection mode – RMS); < 30 dBm (FCC requirement: detection mode – peak power) Operating mode Infrastructure Standard: WPA/ WPA2 PSK, WPA/WPA2 EAP, WPA/WPA2 CCKM Data security EAP method:LEAP,TTLS,TLS,FAST,PEAP-MsChapV2,PEAP-GTC, PEAP-TLS; Encryption : TKIP and AES QoS setting supported QoS A.6.1.
Product Specifications Wireless Specification Priority All communication data types shall have the same priority. Transmission distance Distinct vision distance between the TM80 and the AP is no less than 50 m. Roaming The network switchover is automatically implemented when the TM80 moves from the coverage area of AP1 to the coverage area of AP2, no network interruption alarm event will occur.
Wireless Specification Product Specifications A.6.2 TM70 and AP70 WMTS Specifications A.6.2.1 Technical Specification Specifications 608M Modulation mode GFSK Operating frequency 608MHz(608~614MHz) 1.4GHz(1395~1400MHz and 1427~1432MHz) Channel spacing 600kHz 800kHz or 600kHz Wireless baud rate (data rate) Max 400kbps Max 433kbps for 800kHz channel spacing; Max 400kbps for 600kHz channel spacing. Max.
Product Specifications Wireless Specification Specifications 608M 1.4G Data integrity The time percentage when a TM70 fails to transmit data to the central station shall not exceed 0.1% over a 24-hour period. Data latency Total delay of data transmitted from the TM70 to the central station: ≤ 3 s. Transmission distance Distinct vision distance from the TM70 to the AP shall be no less than 50 m for LOS.
Bluetooth Specification Wireless networking stability Product Specifications The ratio of the communication data lost on the center station from the TM70 is less than 0.1% in 24 hours under the following circumstances: Each of the TM70 roams 30 times and at least 3 TM80s roam simultaneously. A.7 Bluetooth Specification A.7.1 Technical Specification Protocol standard Bluetooth low energy 4.
Product Specifications Measurement Specifications Priority All communication data type shall have the same priority. Transmission distance ■ Distinct vision distance between the TM80s or between the TM70s is no less than 3 m. ■ Distinct vision distance between TM80 and BP10 or between TM70 and BP10 is no less than 3 m. ■ One TM80 can synchronously transport the device configuration to at least other five TM80s in a 10 m2 space.
Measurement Specifications Product Specifications Display Sensitivity 1.25 mm/mV (×0.125), 2.5 mm/mV (×0.25), 5 mm/mV (×0.5), 10 mm/ mV (×1), 20 mm/mV (×2), 40 mm/mV (×4) Accuracy: ± 5% Input signal range ±8 mV (peak-to-peak value) Calibration signal 1 mV (peak-to-peak value) Accuracy: ± 5% Differential input impedance ≥ 5 MΩ Bandwidth (-3dB) Monitor mode: 0.5 Hz to 40 Hz ST mode: 0.
Product Specifications Pace pulse rejection Measurement Specifications When tested in accordance with the IEC60601-2-27: 201.12.1.101.13, the heart rate meter rejects all pulses meeting the following conditions. Amplitude: ±2 mV to ±700 mV Width: 0.1 ms to 2 ms Rise time: 10 μs to 100 μs No overshoot About 50% pulse of ANSI/AAMI EC13 (5d) can trigger the pulse detector, the least changing rate is 20 V/s RTI.
Measurement Specifications Time to alarm for tachycardia Product Specifications Meets the requirements of IEC60601-2-27: Clause 201.7.9.2.9.101 b) 6). Waveform B1h - range: < 11 s B1- range: < 11 s B1d - range: < 11 s B2h - range: < 11 s B2- range: < 11 s B2d- range: < 11 s ST Segment Analysis Measurement range -2.0 mV to +2.0 mV RTI Resolution 0.01 mV Accuracy -0.8 mV to +0.8 mV: ± 0.
Product Specifications Measurement Specifications NOTE • A.8.2.1 A functional tester or SpO2 simulator can be used to determine the pulse rate accuracy. Nonin SpO2 Module SpO2 Measurement range 0% to 100% Resolution 1% Accuracy 70-100%: ±3 digits 0-69%: Not specified Data update rate ≤2s *Studies were performed to validate the accuracy of Pulse Oximeter with Nonin SpO2 sensors by contrast with a CO-Oximeter.
Measurement Specifications Product Specifications Response Time ■ ≤ 25 s (PR 75 bpm, average time 4 heart beats, no disturbance, SpO2 value rises from 70% to 100%) ■ ≤ 35 s (SpO2 value 98%, average time 4 heart beats, no disturbance, PR value rises from 60 bpm to 150 bpm) A.8.2.2 Fitting Curve for Nonin SpO2 Sensors 7000A, 7000P, 8000AA, 8000AP SpO2 = 1.01 × SaO2 – 2.
Product Specifications Measurement Specifications Bland-Altman Plots of the Bias versus the Mean A.8.2.3 Masimo SpO2 Module SpO2 Measurement range 1% to 100% Resolution 1% Accuracy* 70-100%: ±2.0% (measured without motion) 70-100%: ±3.0% (measured with motion) 1-69%: Not specified Low Perfusion Conditions Pulse amplitude: > 0.
Measurement Specifications Product Specifications Measured Arms Values SaO2 range LNCS Adtx, LNCS Pdtx LNCS DCI, LNCS DCIP 70% to 100% ± 2% 2% 70% to 80% 1.55% 0.60% 80% to 90% 1.07% 0.54% 90% to 100% 1.64% 0.60% PR Measurement range 25 bpm to 240 bpm Resolution 1 bpm Accuracy ±3.0 bpm(measured without motion) ±5.0 bpm (measured with motion) PI Measurement range 0.02% to 20% Least resolution 0.
Product Specifications Measurement Specifications DCI/DCIP A.8.2.
Measurement Specifications Accuracy Product Specifications 70% to 100%: ±2% ABS 60-80%: ±3 ABS 0-59%: Not specified PR A - 22 Measurement range 20 bpm to 300 pm Accuracy 20 bpm to 250 bpm: ±3 bpm 251 bpm to 300 bpm: Not specified TM80/TM70 Telemetry Monitor Operator’s Manual
Product Specifications A.8.2.6 Measurement Specifications Fitting Curve for Nellcor SpO2 Sensors ■ The accuracy of Nellcor SpO2 Sensors Sensor Motion # of Data Points ARMS (%) SpO2 Acceptance Criteria 70% - 100% (%) Pass/ Fail DS-100A (PN:9000-10-05161 ) No 411 2.16 ≤3.0 Pass D-YS (PN: 0010-1012476), OXI-P/I (PN: 9000-1007308) No 458 1.96 ≤3.5 Pass ■ Modified Bland-Altman for SpO2 - DS-100A Sensor (No Motion): SaO2 vs. (SpO2 - SaO2) 1. SpO2 - SaO2 (%) 2. SaO2 (%) 3.
Measurement Specifications ■ Modified Bland-Altman for SpO2 - D-YS, OXI-P/I Sensors (No Motion): SaO2 vs. (SpO2 - SaO2) 1. SpO2 - SaO2 (%) A.8.3 Product Specifications 2. SaO2 (%) 3. Upper 95% LoA 4. Mean Bias 5.
B EMC and Radio Regulatory Compliance TM80/TM70 Telemetry Monitor Operator’s Manual B-1
EMC B.1 EMC and Radio Regulatory Compliance EMC The device meets the requirements of IEC 60601-1-2: 2014. WARNING • • • • • Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this device could result in increased electromagnetic emissions or decreased electromagnetic immunity of this device and result in improper operation. Use of this device adjacent to or stacked with other device should be avoided because it could result in improper operation.
EMC and Radio Regulatory Compliance EMC RF emissions CISPR 11 Class B* Only TM80/TM70 Telemetry Monitor and BP10 (subpart) compliance. The devices are suitable for use in all establishments, including domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes.
EMC EMC and Radio Regulatory Compliance ■ Accuracy ■ Function ■ Accessories identification ■ Data stored ■ Alarm ■ Detect for connection Guidance and Declaration - Electromagnetic Immunity The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment.
EMC and Radio Regulatory Compliance EMC Guidance and Declaration - Electromagnetic Immunity The device is intended for use in the specified electromagnetic environment. The customer or the user of the device should assure that it is used in such an environment as described below. IEC 60601 Test level Compliance level 3 Vrms 150 kHz to 80 MHz 3 Vrms 6 Vrms in ISM bands and amateur radio bands between 0,15 MHz and 80 MHz 6 Vrms Radiated RF EM fields IEC61000-4-3 10V/m 80 MHz to 2.
EMC EMC and Radio Regulatory Compliance a The ISM (industrial, scientific, and medical) bands between 150 kHz and 80 MHz are 6.765 MHz to 6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz.
EMC and Radio Regulatory Compliance B.2 Radio Regulatory Compliance Radio Regulatory Compliance The TM80/TM70 telemetry monitor complies with the requirements of FCC Part 95: Radio frequency Radiation Exposure Information For body worn operation, this equipment has been tested and meets the FCC and CE RF exposure guidelines when used with the accessories supplied or those approved for use with this product.
Radio Regulatory Compliance EMC and Radio Regulatory Compliance RF parameter (Wi-Fi Module) for TM80 Protocol IEEE 802.
C Symbols and Abbreviations Units..............................................................................................................................C-2 Symbols .......................................................................................................................C-3 Abbreviations ............................................................................................................
Units C.1 Symbols and Abbreviations Units A C-2 ampere Ah ampere hour bpm beats per minute °C centigrade cc cubic centimeter cm centimeter dB decibel DS dyne.
Symbols and Abbreviations C.2 C.
Abbreviations C-4 Symbols and Abbreviations ECG electrocardiograph EMC electromagnetic compatibility err error ES electrosurgical ESU electrosurgical unit HR heart rate HT height IEC International Electrotechnical Commission ISO International organization for standardization MRI magnetic resonance imaging LA(L) left arm LAP left atria pressure LED light emitting diode LL(F) left leg Loop loop read-write test fail M, MEAN mean pressure O2 oxygen P power PR pulse rate
Caution: This device complies with Part 15 of the FCC rules and Industry Canada license‐exempt RSS standard(s). Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. The manufacturer is not responsible for any radio or TV interference caused by unauthorized modifications or change to this equipment.
