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HUM sat 805 Manual

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HUM Gesellschaft für Homecare
und Medizintechnik mbH
Zum Pier 79
44536 Lünen
Germany
Tel.: +49 (0) 231 / 88 08 85 - 0
Fax: +49 (0) 231 / 88 08 85 - 58
E-Mail: sales@hum-online.de
Internet: www.hum-online.de
ID 3701405 Rev. 1.0 | 21.01.2019

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  • Page 1 HUM Gesellschaft für Homecare und Medizintechnik mbH Zum Pier 79 44536 Lünen Germany Tel.: +49 (0) 231 / 88 08 85 - 0 Fax: +49 (0) 231 / 88 08 85 - 58 E-Mail: sales@hum-online.de Internet: www.hum-online.de ID 3701405 Rev. 1.0 | 21.01.2019...

  • Page 2: Table Of Contents

    805 Pulse Oximeter 1 General ............................... 7 1.1 Information on Operating Instructions ....................7 1.2 Symbol Designation ..........................7 1.3 Liability and Warranty ..........................8 1.4 Copyright Protection ..........................9 1.5 Removal and Disposal ..........................9 2 Safety ............................... 11 2.1 Intended Use ............................
  • Page 3 805 Pulse Oximeter 4.5.3 USB2.0 Interface ..........................25 4.6 Identification Nameplate ........................26 5 Shipping, Packaging and Storage ......................27 5.1 Shipping Inspection ..........................27 5.2 Scope of Delivery ........................... 27 5.3 Packaging ............................... 28 5.4 Storage ..............................28 6 Operation ............................
  • Page 4 805 Pulse Oximeter 7.1 General ..............................43 7.2 Menu Operation............................. 43 7.2.1 Using the Trim Knob ........................43 7.2.2 Calling the Main Menu ........................44 7.2.3 Menu Structure ..........................44 7.3 Switching on the Unit ..........................45 7.4 Turning the Unit off ..........................47 7.5 Alarm Limits (Alarm limits) ......................
  • Page 5 805 Pulse Oximeter 7.7.5 External Alarm (Nurse Call) ...................... 65 7.7.6 Device Information (Product Info)..................65 7.7.7 Analogue Interface (Analogue out) ..................66 7.8 Alarm lists (Alarm lists) ....................... 67 7.8.1 Vital Alarm List (Vital alarm list) ..................68 7.8.2 Total Alarm List (Total alarm list) ..................
  • Page 6 805 Pulse Oximeter 10 Disinfecting, Cleaning and Maintenance ................... 89 10.1 Cleaning Plan ............................89 10.2 Disinfection ............................90 10.2.1 Disinfecting the Unit ........................90 10.2.2 Disinfecting the Masimo sensors ....................90 10.2.3 Disinfecting the patient cable ....................... 91 10.3 Cleaning..............................

  • Page 7: General

    805 Pulse Oximeter General 1 General 1.1 Information on Operating Instructions These operating instructions describe the safe and appropriate handling of the unit. Adherence to specific safety notices and instructions as well as to the applicable on-site accident prevention regulations and general safety regulations is an imperative requirement.

  • Page 8: Liability And Warranty

    We reserve the right to make technical changes on the product within the context of improving and advancing performance characteristics. We warrant our sat 805 to be free from manufacturing defects in materials and workmanship for two years starting from the date of delivery.

  • Page 9: Copyright Protection

    • The product in question is either software, or an expendable item, such as a fuse, battery, etc. This warranty is limited to the repair and/or replacement, at HUM Gesellschaft für Homecare und Medizintechnik mbH sole discretion, of the defective product during its warranty period. HUM Gesellschaft für Homecare und Medizintechnik mbH will replace any product found to be defective within the first three...
  • Page 10 805 Pulse Oximeter – The disposal of infectious supplies (e.g. Masimo sensor with an infection from the user) has to be accomplished by a certified disposal company. You can request its address from city council. – The unit contains batteries, which are not allowed to be discarded into the domestic refuse.

  • Page 11: Safety

    Proper adherence to these operating conditions, as well as the data and the instructions are considered to be proper use. The unit may not be opened or modified. Parts other than those pertaining to the supply scope may be used only after release by the company, HUM Gesellschaft für Homecare und Medizintechnik mbH.

  • Page 12: Possible Misapplications

    805 Pulse Oximeter Safety 2.1.1 Possible Misapplications WARNING! Fire Hazard! The pulse oximeter may not be used during nuclear magnetic resonance imaging tests. The electrical current induced there can cause burns. This may affect the MRI image and the MRI device may affect the accuracy of the Pulse Oximetry parameters and measurements.

  • Page 13: User Responsibility

    805 Pulse Oximeter Safety – The presence of carboxyl (HbCO)-, methaemoglobin, (Hbmet) or diluted dyes or substances containing dyes in the blood stream can influence the measurements and can lead incorrectly to higher values. – When using the pulse oximeter near equipment, which emits strong electromagnetic signals, (e.g.

  • Page 14: Possible Dangers From The Equipment

    805 Pulse Oximeter Safety 2.3 Possible Dangers from the Equipment The unit has undergone endangerment analysis. The construction and execution of the unit is expanded upon and is equivalent to the current state of technology. And yet risks remain! WARNING! Health Risk! Particular supervision is necessary if the unit is used near children or bedridden individuals.

  • Page 15: Users

    2.5 Customer Service If assistance in commissioning, in operation or maintenance is needed, or you would like to report an unexpected operation or incident with sat 805, you can contact HUM Gesellschaft für Homecare und Medizintechnik mbH as follows: Monday - Thursday 8.00 a.m. - 4.30 p.m. | Friday 8.00 a.m. - 3.45 p.m.

  • Page 16: Technical Data

    805 Pulse Oximeter Technical Data 3 Technical Data 3.1 Unit Data Feature Value Unit dimensions (L x W x H) 92 x 240 x 104 mm Weight, 900 g including batteries 100-240 V ~50/60 Hz Power pack 9.3 V DC +/-1 %...

  • Page 17: Masimo Pulse Oximetry

    805 Pulse Oximeter Technical Data 3.2 Masimo Pulse Oximetry Characteristic Data Pulse Display range 1-100 % 25-240 1/min Accuracy – without Movement, Adults, 25-240 1/min+/- 3 digits Children and Newborns Accuracy – with Movement, Adults, Children 25-240 1/min+/- 5 digits...
  • Page 18 805 Pulse Oximeter Technical Data NOTICE! A functional tester cannot be used to assess the accuracy of a pulse oximeter probe or a pulse oximeter. NOTICE! If there is independent demonstration that a particular calibration curve is accurate for the combination of a pulse oximeter and a pulse oximeter probe, then a functional tester can measure the contribution of a monitor to the total error of a monitor/probe system.

  • Page 19: Factory Default Settings

    805 Pulse Oximeter Technical Data 3.3 Factory Default Settings Setting Value Alarm tone volume Pulse tone volume Alarm tone mute time 60 sec Contrast Averaging Time 8 sec Perfusion sensitivity normal Nurse Call N(ormally) O(pen) Alarm limit SpO high...

  • Page 20: Assembly

    805 Pulse Oximeter Assembly 4 Assembly 4.1 Displays and Controls Green mains LEDs (behind the ON/OFF- button) ON-/OFF button LC Display Trim knob incl. yellow/red alarm LEDs Connector for patient cable Fig. 1: Display and Controls 4.2 Connections Connections in the rear panel:...

  • Page 21: Lc Display

    805 Pulse Oximeter Assembly 4.3 LC Display Fig. 4: LC Display Perfusion index, graphical and numerical display in % IQ bar, displays graphically the Signal IQ in normal operation. The Signal IQ is an indicator for signal insufficiency. Remaining memory in % Status line: Alarm messages, time and date, memory status and other parameters are displayed.

  • Page 22: Pictograms On The Device

    805 Pulse Oximeter Assembly What is signal IQ™? Signal-IQ™ is a measurement for Signal-Identification and Signal-Quality. Masimo developed this indicator to give the user information when a measurement is questionable. Signal-IQ™ is a visual reliability indicator for the oxygen saturation and pulse frequency measurements.
  • Page 23 805 Pulse Oximeter Assembly Symbol Meaning The device and its components are not allowed to be discarded into normal household waste Manufacturer and year of manufacture Notified Body TÜV Rheinland LGA Products GmbH Legitimate air pressure range for storage...

  • Page 24: Interfaces

    805 Pulse Oximeter Assembly 4.5 Interfaces The unit features following interfaces: – Interface connectors in the rear panel of the unit (from left to right): – Nurse call – Analogue interface (right) Fig. 5: Interface Connector – DC input –...

  • Page 25: Nurse Call Alarm

    805 Pulse Oximeter Assembly 4.5.2 Nurse Call Alarm The nurse call alarm interface can be configured for connection to a nurse call system or a remote alarm device. NOTICE! Even if the acoustic alarm has been silenced on the device, the acoustic alarms still always sound on the external alarm interface.

  • Page 26: Identification Nameplate

    805 Pulse Oximeter Assembly 4.6 Identification Nameplate The nameplate is located on the bottom side of the unit. The following information can be found there: – Manufacturer – Unit description – Production year – Serial number – Fig. 7: Identification Nameplate Power supply –...

  • Page 27: Shipping, Packaging And Storage

    805 Pulse Oximeter Shipping, Packaging and Storage 5 Shipping, Packaging and Storage 5.1 Shipping Inspection Examine the delivery immediately upon receipt for completeness and possible shipping damage. With visible external shipping damage do not accept delivery or only with reservation.

  • Page 28: Packaging

    805 Pulse Oximeter Shipping, Packaging and Storage 5.3 Packaging To minimize damage always transport or send the unit in its original packaging. We recommend you to save the packaging. WARNING! Risk of Suffocation! Packaging materials are not intended for children. The danger of suffocation exists.

  • Page 29: Operation

    805 Pulse Oximeter Operation 6 Operation 6.1 Environmental Conditions The unit uses high frequency energy exclusively for its internal functions. That is why its high frequency emission is very low and it is improbable that electronic units in close vicinity can be disturbed.
  • Page 30 805 Pulse Oximeter Operation ATTENTION! Never use multiple electric socket strips to supply the unit. Never connect the unit to a switched network socket. Only use the power pack plug supplied with the unit. Install the unit in a way that the unit can be easily disconnected from the power supply.

  • Page 31: Mains Power Failure Alarm

    805 Pulse Oximeter Operation 6.3.1 Mains Power Failure Alarm In case of a mains power failure, an alarm is triggered respectively. At the same time, the unit automatically switches from mains to battery supply without any interruption. Approx. 5 sec. After mains failure, an alarm (medium priority is triggered).

  • Page 32: Connections

    805 Pulse Oximeter Operation 6.4 Connections 6.4.1 Connecting the Patient Cable and Sensor Connect the patient cable connector into the unit socket. The plug only fits in one direction and audibly snaps in. Fig. 13: Connect Patient Cable Select the required Masimo-Sensor, see chapter 6.6.

  • Page 33: Disconnecting The Sensor

    805 Pulse Oximeter Operation 6.4.2 Disconnecting the Sensor LNOP Sensors Press the two disconnect buttons (1) together. The locking mechanism unlocks the sensor plug. Remove the plug from the coupling (2). Fig. 17: LNOP Sensor Coupling LNCS Sensors Lift the protective cover (1).

  • Page 34: Disconnecting The Patient Cable From The Unit

    805 Pulse Oximeter Operation 6.4.3 Disconnecting the Patient Cable from the Unit Press the two disconnect buttons (1) at the patient cable socket together. The locking mechanism unlocks the patient cable. Remove the connector. ATTENTION! Fig. 20: Patient Plug Coupling Do not apply pressure when removing the plug.

  • Page 35: Using Masimo-Sensors

    805 Pulse Oximeter Operation WARNING! Connectors can disconnect during Movement! When moving the unit during monitoring, absolutely ensure the correct position of the patient connector. Should the connector accidentally become disconnected an alarm sounds. 6.6 Using Masimo-Sensors CAUTION! Danger from not Observing User Instructions! These sensors were developed only for usage of pulse oximeters with MasimoSET-technology.

  • Page 36: Selecting The (Correct) Sensor

    Select the sensor based on the patient’s age and weight and its re-usability. The Table is a guide. The correct sensor has to be matched individually to the patient. NOTICE! The latest list of all sensors is directly available from HUM Gesellschaft für Homecare und Medizintechnik mbH. 6.6.1.1 Adhesive Sensors...

  • Page 37: Reusable Sensors

    805 Pulse Oximeter Operation WARNING! Allergy Risk! The use of Masimo and RD SET disposable SpO -sensors is contraindicated on patients who develop allergic reactions to the tape. The sensors must be re-positioned every 8 hours - and as soon as lack of blood circulation or skin surface injury is displayed - remove them again and attach them in another area.

  • Page 38: Patient Cable

    805 Pulse Oximeter Operation WARNING! Danger with Long-Term Application! The use of reusable Masimo and RD SET- sensors is contraindicated with long term application. These sensors are not suitable for long-term monitoring. They must be attached every four hours - and as soon as lack of blood circulation or skin surface injury is displayed - remove them and attach them in another area.

  • Page 39: 90%-Lifetime Or „Near Expiration"-Message

    805 Pulse Oximeter Operation The lifetimes are defined as follows: Duration if Duration if Duration if Active Patient Sensor / Cable Monitoring 24 Monitoring 12 Monitoring 8 Monitoring Limit Hours Per Day Hours Per Day Hours Per Day Single-patient-use...

  • Page 40: Life Time Exceeded

    805 Pulse Oximeter Operation The following technical messages are output when 90 % of the specified service life of the patient cable or sensor is reached. Technical message: „Cable near expiration“ Fig. 21: Cable near expiration Technical message: „Sensor near expiration“...
  • Page 41 805 Pulse Oximeter Operation Technical message: „ X-CAL: Sensor expired“ Fig. 25: X-CAL: Sensor expired Technical message: „ X-CAL: Adh. sensor expired“ Fig. 26: X-CAL: Adh. sensor expired In contrast to sensors, a patient cable is never switched off after its service life has been reached.

  • Page 42: Using The Interfaces

    805 Pulse Oximeter After the cause of the alarm has been eliminated, this alarm is downgraded again to the technical message "Sensor expired". If, on the other hand 1. the sensor-pulse oximeter connection is disconnected or 2. longer than 2 hours the sensor would not have been on the patient or 3.

  • Page 43: Control

    805 Pulse Oximeter Control 7 Control 7.1 General Control of the unit takes place on the LCD-display in combination with the trim knob. In the directional text of this user manual, the texts, appearing in the display, are highlighted to assist in understanding.

  • Page 44: Calling The Main Menu

    805 Pulse Oximeter Control 7.2.2 Calling the Main Menu Press the trim knob. The main menu is displayed in the LC display. Fig. 32: Main Menu 7.2.3 Menu Structure After selecting a menu item further menu items can be selected subsequently. Therefore in some cases it is necessary to select several menu items one after the other before the final setting can be made.

  • Page 45: Switching On The Unit

    805 Pulse Oximeter Control 7.3 Switching on the Unit Level 1 Level 2 Level 3 Remark Configuration Acoust. Alarms Volume pulse Configuration of the Volume alarm acoustical alarms Silence Time Signal process Algorithm mode Setting of pulse oximetry parameters...
  • Page 46 805 Pulse Oximeter Control Press ON/OFF button (1). A signal sound activates. An optical, audio, and internal self examination is completed: – The LEDs are activated. – A dark and bright test picture appears briefly on the LC display.

  • Page 47: Turning The Unit Off

    805 Pulse Oximeter Control NOTICE! In case the Masimo sensor is not connected or not correctly on the Fig. 35: Sensor off Patient! patient, a corresponding error message is displayed, e.g. "Sensor off Patient!". In addition an alarm sound is heard.

  • Page 48: Alarm Limits (Alarm Limits)

    805 Pulse Oximeter Control NOTICE! Should the ON/OFF process be interrupted the last readings before the ON/OFF process appear for approx. 5 seconds. The monitoring remains intact for the entire time. The unit is now being turned off. 7.5 Alarm Limits (Alarm limits)

  • Page 49: Setting The Alarm Limits

    805 Pulse Oximeter Control 7.5.1 Setting the Alarm Limits Starting from the normal display, call:  Alarm limits Select SpO2 hi, for setting the upper alarm limits, Fig. 39: Alarm Limits select SpO2 lo, for setting the lower alarm limit...

  • Page 50: Setting The Alarm Filter

    805 Pulse Oximeter Control 7.5.2 Setting the Alarm Filter WARNING! Incorrectly set alarm limits endanger risk of non-alerting! Activating or changing the alarm filter settings is a serious intervention in the device functions and may never be done without consulting the doctor in charge of the treatment! For canceling short and therefore irrelevant alarm conditions, an alarm filter can be set.
  • Page 51 805 Pulse Oximeter Control Select the alarm filter to be changed by pressing the trim knob. Set the new period (in seconds) value by turning the trim knob. Fig. 43: Modifying the Alarm Filter Confirm the new value by pressing the trim knob.

  • Page 52: Plethysmogram Display (Pleth-Display)

    805 Pulse Oximeter Control 7.6 Plethysmogram Display (Pleth-display) In this menu, the display is configured. Following modes are available: Stretched, normalized plethysmogram Fig. 46: Plethysmogram, stretched Compressed, normalized plethysmogram Fig. 47: Plethysmogram, compressed Big numbers only – without plethysmogram Fig.

  • Page 53: Configuration (Configuration)

    805 Pulse Oximeter Control 7.7 Configuration (Configuration) 7.7.1 Screen options (Screen) Starting from the main menu, call:  Configuration  Screen Select Backlight, Contrast, Home Fig. 50: Screen mode or Language Confirm the selection by pressing the trim knob.

  • Page 54: Backlight (Backlight)

    805 Pulse Oximeter Control 7.7.1.2 Backlight (Backlight) This function activates the LCD backlight; settings are “ON” and “OFF”. Starting from the main menu, call:  Configuration  Screen  Backlight Adjust the setting ON/OFF by turning Fig. 52: Backlight the trim knob.

  • Page 55: Access Permissions (Home Mode)

    805 Pulse Oximeter Control 7.7.1.4 Access Permissions (Home Mode) Starting from the main menu, call:  Configuration  Home Mode Following access permissions may be set: – HomeCare Mode ON (Home Mode ON) – HomeCare Mode OFF (Home Fig. 54: Access Permissions Mode OFF) –...
  • Page 56 805 Pulse Oximeter Control Access Permissions HomeCare ON HomeCare OFF Algorithm Mode Averaging Time SmartTone Artifact-Filter Backlight Contrast Home Mode (Access permission) Language Nurse Call Analog out Clock Product Info - = not allowed + = allowed Setting the Access Permission: Starting from the main menu, call: ...

  • Page 57: Acoustical Alarms (Acoust. Alarms)

    805 Pulse Oximeter Control Set the correct number. Repeat steps 3 and 4 until the complete code is entered. Confirm the code by selecting Accept. NOTICE! An invalid access code is answered by the error message: "Incorrect Fig. 56: Invalid Access Code access code! “...

  • Page 58: Alarm Tone Volume (Volume Alarm)

    805 Pulse Oximeter Control NOTICE! Every incremental change emits the actual volume strength once. Confirm this setting by pressing the trim knob. NOTICE! This de-activation of the pulse signal tone is not shown on the display. 7.7.2.2 Alarm Tone Volume (Volume Alarm) Starting from the main menu, call: ...

  • Page 59: Alarm Silence Time (Silence Time)

    805 Pulse Oximeter Control NOTICE! If you select a setting of less than 5, a warning message is displayed during the next power-on cycle reminding the operator at a possibly too silent setting. NOTICE! An alarm volume of <1 is not stored permanently.

  • Page 60: Masimo Signal Processing (Signalprocessing)

    805 Pulse Oximeter Control NOTICE! During the alarm silence time, the alarm silence symbol appears to indicate that the option is active (the number below shows the remaining time in seconds). WARNING! New alarms cannot be detected! If a new alarm condition occurs during the alarm tone mute duration, the new alarm will be displayed after completion of the mute duration.

  • Page 61: Perfusion Sensitivity (Algorithm Mode)

    805 Pulse Oximeter Control The longer the length of time, in which measured values are collected, the lower the display value varies. WARNING! Variations in oxygen saturation cannot be recognized! Rapid changes in oxygen saturation are not recognized with the selection of a long averaging time! Starting from the main menu, call: ...
  • Page 62 If low perfusion combined with movement inhibits the Masimo SET monitor from reading, switch from APOD to Normal or Max sensitivity. Three sensitivity levels enable the clinician to tailor the response of the sat 805 to the needs of the particular patient situation - a truly unique and powerful capability.

  • Page 63: Smarttone (Smarttone)

    805 Pulse Oximeter Control 7.7.3.3 SmartTone (SmartTone) The SmartTone is a feature that affects pulse beep and Signal IQ waveforms and can be selected as “ON” or “OFF”. When the SmartTone is ON, the Masimo SET algorithms will continue to provide pulse beep and Signal IQ waveforms even when the pleth is noisy due to motion or low signal conditions.

  • Page 64: System Time (Clock)

    805 Pulse Oximeter Control 7.7.4 System Time (Clock) The function sets the date and time of the unit. For a precise analysis of the stored monitoring data, it is necessary to set the device time always correctly. ATTENTION! The user will need to adjust the time from summer to winter and vice versa manually! Starting from the main menu, call: ...

  • Page 65: External Alarm (Nurse Call)

    805 Pulse Oximeter Control 7.7.5 External Alarm (Nurse Call) WARNING! Danger by incorrect Configuration! This setting is only allowed to be modified by experienced and training personal. A wrong setting might de-activate the external alarm. If the unit shall be connected via the external alarm interface, this interface can be set in accordance to the respective system.

  • Page 66: Analogue Interface (Analogue Out)

    805 Pulse Oximeter Control – Perfusion sensitivity setting – Signal averaging time setting NOTICE! The displayed information is read-only. Starting from the main menu, call:  Product Info Leave that window by confirming Return. Fig. 67: Device Information 7.7.7 Analogue Interface (Analogue out) If required a calibration signal can be output at the analog interface.

  • Page 67: Alarm Lists (Alarm Lists)

    Control 7.8 Alarm lists (Alarm lists) The sat 805 continuously stores monitoring data. SpO , pulse and IQ values are continuously logged on a second-by-second basis. In addition, data related to monitoring, such as alarms and device settings, are also stored.

  • Page 68: Vital Alarm List (Vital Alarm List)

    805 Pulse Oximeter Control 7.8.1 Vital Alarm List (Vital alarm list) Starting from the main menu, call:  Data  Vital alarm list The list of vital alarms is displayed. From left to right, this shows: Fig. 70: Vital Alarm List –...

  • Page 69: Alarm Details

    805 Pulse Oximeter Control occurred (e.g. 23.10.06, 10:48h) – The duration (e.g. 5 minutes 40 seconds) – And the extreme value or type of alarm event (e.g. Sensor failure) Turn the encoder clockwise to browse through the list. Turn the encoder clockwise to show a more recent alarm (i.e.

  • Page 70: Trend Display (Trend)

    IQ values are recorded every second. In addition, it also stores monitoring-related data such as alarms and device settings. The basic sat 805 model stores up to 160 hours of continuous monitoring with a maximum of 4,000 alarm list entries.

  • Page 71: Exporting The Data

    805 Pulse Oximeter Control NOTICE! When the marker reaches the left or right hand edge of the display, the area shown is moved by half a screen to one side. The screen marker cannot move beyond the start or the end of the data.
  • Page 72 805 Pulse Oximeter Control Switch on the device. It automatically detects the SD card and goes into data transmission mode. After a short while the data transfer is complete – for the complete file about Fig. 76: Transmitting Data 20 seconds are needed.

  • Page 73: Alarms

    805 Pulse Oximeter Alarms 8 Alarms 8.1 General As a monitoring system, the sat 805 pulse oximeter is equipped with acoustic and visual signals for many alarm situations. It alerts the user: – When deviations from pre-set alarm limits occur –...

  • Page 74: Alarm Categories

    805 Pulse Oximeter Alarms – Attaching the sensor to a limb at the same time as a blood pressure cuff, an arterial catheter or an intravascular line. Loss of pulse signal might occur under the following conditions: – The sensor is attached too tightly.

  • Page 75: Spo 2 Alarm

    805 Pulse Oximeter Alarms With high priority alarms – the high-priority alarm tone sounds, – the red alarm-LEDs (1) flash and – a status line message appears. These signals remain active for as long as the condition causing the alarm persists.

  • Page 76: Sensor Alarms

    805 Pulse Oximeter Alarms 8.2.1.3 Sensor Alarms NOTICE! X-CAL or lifetime related alarms (*) might not be present in all devices. To confirm, please check in the product info menu (see chapter 7.7.6): only devices with DSP version 5.X.X.X will support the X-CAL related alarms and messages.

  • Page 77: System Alarms

    805 Pulse Oximeter Alarms Status Line Message Description Solution „Incompatible The device has detected a sensor that is not Only connect approved sensor!“ (*) approved for this system. Masimo sensors to the unit. „Incompatible The device has detected a sensor that is not Only connect approved adh.
  • Page 78 An unexpected device restart has occurred. The internal non-volatile memory has reported an SYST ALARM: NVRAM error! error. The integrated circuit that monitors the sat 805 has SYST ALARM: WDT error! reported an error. SYST ALARM: Reset monitor The integrated circuit that monitors the sat 805 has...

  • Page 79: Medium Priority Alarms

    805 Pulse Oximeter Alarms Message Source reported an error. An error has occurred in the software stack SYST ALARM: Stack overfl. processing. SYST ALARM: ROM-CRC! A data security error has occurred. 8.2.2 Medium Priority Alarms WARNING! Insufficient Monitoring at Medium Priority Alarms.

  • Page 80: Low Priority Alarms

    805 Pulse Oximeter Alarms Medium Priority Alarms: Status Line Description Solution Message MS-Comm. lost Data transfer error. The device has No user intervention data! registered this fact and has required. automatically restored communication.  Clean the sensor No data!

  • Page 81: Status Message

    DC power supply is also the DC power pack. Is the green interrupted/defect. LED glowing? Loudspeaker defective! The sat 805 has detected a A defective loudspeaker can only be defective alarm replaced by qualified personnel. Notify loudspeaker and has your medical technology dealer.

  • Page 82: Battery Alarms

    805 Pulse Oximeter Alarms Status Line Message Description Solution The unit has determined a scattered or foreign light source. Do not expose the sensor to a This can occur with particularly Ambient Light! direct light source, or shade from strong lighting from the outside the outside.

  • Page 83: Battery Alarm (Low Priority)

    805 Pulse Oximeter Alarms 8.4.1 Battery Alarm (low priority) Status Line Message Description Solution Battery low! Remaining operation time of Recharge battery. one hour or less. A flashing battery icon will be displayed. 8.4.2 Battery Alarm (medium priority) Status Line Message...

  • Page 84: Malfunctions And Troubleshooting

    805 Pulse Oximeter Malfunctions and Troubleshooting 9 Malfunctions and Troubleshooting WARNING! Insufficient Monitoring by Malfunctions! With the occurrence of function failure the patient cannot be correctly monitored in certain cases. The cause of the function failure must be removed as soon as possible.
  • Page 85 805 Pulse Oximeter Malfunctions and Troubleshooting Message Cause Solution Error message after self-test run Internal failure. Turn the unit ON and OFF. and after unit is turned on. Inform medical device supplier. No function of the alarm loud Defective alarm loudspeaker.
  • Page 86 805 Pulse Oximeter Malfunctions and Troubleshooting Message Cause Solution Status Line Message: With too low perfusion or whilst If the unit remains in this the initialisation the unit tries to situation after turning on or if the “Pulse search! “...
  • Page 87 805 Pulse Oximeter Malfunctions and Troubleshooting Message Cause Solution Status Line Message: The adhesive sensor has reached Have a new sensor ready. 90% of its specified life time. "Adh. Sensor near expiration!" Status Line Message: The patient cable has reached Replace patient cable.
  • Page 88 805 Pulse Oximeter Malfunctions and Troubleshooting Message Cause Solution Status Line Message: The unit has discovered a sensor Use approved Masimo not approved for this system. accessories only. “Unrecognized adh. sensor!“ The unit has discovered a sensor Use approved Masimo...

  • Page 89: Disinfecting, Cleaning And Maintenance

    (outside of the hospital) Dispose of disposable sensors Every 4 Weeks (outside of the hospital) Clean and disinfect sat 805 included carrying bag, AC adapter, At change of patient patient cable and reusable sensors Dispose of disposable sensors At change of patient...

  • Page 90: Disinfection

    805 Pulse Oximeter Disinfecting, Cleaning and Maintenance 10.2 Disinfection It has been proven, wipe disinfection is more thorough and comprehensive than spray disinfection. We recommend to use Meliseptol rapid (manufacturer B.Braun) in the same manner like for the above outlined cleaning procedure.

  • Page 91: Disinfecting The Patient Cable

    805 Pulse Oximeter Disinfecting, Cleaning and Maintenance Disinfect the reusable Masimo sensors as follows: Disconnect the connection from both the patient and the patient cable. For disinfection, use a 1:10 bleach /water solution. Saturate a cloth or gauze pad with the cleaning solution und wipe all surfaces of the sensor and cable.

  • Page 92: Cleaning

    805 Pulse Oximeter Disinfecting, Cleaning and Maintenance 10.3 Cleaning 10.3.1 Cleaning the Unit ATTENTION! Danger to the Unit! Do NOT use strong cleaning agents with petroleum base or acetone solution. Proceed particularly cautiously in the LCD display area to avoid scratching the surface.

  • Page 93: Cleaning Of Patient Cables

    Never correct defects on the unit, repair it or perform maintenance yourself! Corrections of defects, repairs or any maintenance should be done exclusively by HUM Gesellschaft für Homecare und Medizintechnik mbH or by a HUM Gesellschaft für Homecare und Medizintechnik mbH...

  • Page 94: Regular Check

    805 Pulse Oximeter Disinfecting, Cleaning and Maintenance 10.4.1 Regular Check The unit should be checked by the manufacturer or an authorized dealer once every 36 months. Contact the medical device supplier for the correct information. 10.4.2 User Check of Alarm Function If difficulties occur with the unit or it is suspected the unit no longer functions properly, the following function test can be performed.
  • Page 95 805 Pulse Oximeter Disinfecting, Cleaning and Maintenance The new alarm value for the upper pulse frequency will be accepted. The alarm will activate. The red LED blinks and the alarm will sound. Reset the upper alarm limit to a value of 10 1/min above the indicated pulse frequency value.

  • Page 96: Accessories And Replacement Parts

    805 Pulse Oximeter Accessories and Replacement Parts 11 Accessories and Replacement Parts ATTENTION! Wrong or defective accessory or replacement parts as well as parts from secondary manufacturers can lead to severe damage to the unit. All guarantees and service agreements are void without prior notice by the use of unapproved accessories or replacement parts.

  • Page 97: Advanced Information

    805 Pulse Oximeter Advanced Information 12 Advanced Information 12.1 Averaging Time This figure represents a faster desaturation slope and a more realistic, noisier saturation signal curve 1). Curves 3 and 4 underestimate the depth of the fall in saturation. Curve 2, faster averaging, can cross a low saturation alarm limit sooner than curve 3, normal averaging, or curve 4, slower averaging, which might not cause an alarm condition at all.

  • Page 98: Alarm Signal Generation Delay

    805 Pulse Oximeter Advanced Information 12.2 Alarm Signal Generation Delay Graphic Representation of Components of Alarm System Delay The delay due to the pulse oximeter equipment processing and averaging is t , the alarm condition delay. The interval t , the alarm signal generation delay, is attributed to the alarm system strategy and the communication time to the alarm signal generation device or distributed alarm system (e.g.

  • Page 99: Index

    805 Pulse Oximeter Index 13 Index Battery Alarm..........82 Access permissions ........55 Accessories ............ 96 Charging the batteries ........29 Acoustical alarms .......... 57 Cleaning ............89 Advanced information ........97 Clinic ............. 55 Alarm categories ........... 74 Clock .............
  • Page 100 805 Pulse Oximeter Index Disposal ............28 Mains operation ..........29 Environmental Conditions ......29 Mains power failure alarm ......31 External Alarm ..........65 Maintenance ..........93 Malfunctions ..........84 FastSat™ ............61 Masimo Signal Processing ......60 Masimo-Sensors ...........
  • Page 101 805 Pulse Oximeter Index Replacement Parts ........96 Total .............. 70 Total alarm list ..........68 Safety ............. 11 Transport ............27 Scope of delivery ........... 27 Trend display ..........70 Screen ............53 Turning off ............ 47 SD Card ............71 Sensor Alarms ..........

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