HUM sat 805 User manual

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: [email protected]
Internet: www.hum-online.de
ID 3701405 Rev. 1.0 | 21.01.2019

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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.......................................................................................................................................... 11
2.1.1 Possible Misapplications ................................................................................................................. 12
2.2 User Responsibility................................................................................................................................. 13
2.3 Possible Dangers from the Equipment .................................................................................................. 14
2.4 Users ...................................................................................................................................................... 15
2.5 Customer Service ................................................................................................................................... 15
3 Technical Data................................................................................................................................... 16
3.1 Unit Data ................................................................................................................................................ 16
3.2 Masimo Pulse Oximetry......................................................................................................................... 17
3.3 Factory Default Settings......................................................................................................................... 19
3.4 Life Times ............................................................................................................................................... 19
4 Assembly .......................................................................................................................................... 20
4.1 Displays and Controls............................................................................................................................. 20
4.2 Connections ........................................................................................................................................... 20
4.3 LC Display ............................................................................................................................................... 21
4.4 Pictograms on the Device ...................................................................................................................... 22
4.5 Interfaces ............................................................................................................................................... 24
4.5.1 Analogue Interface.......................................................................................................................... 24
4.5.2 Nurse Call Alarm.............................................................................................................................. 25

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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 ......................................................................................................................................... 29
6.1 Environmental Conditions ..................................................................................................................... 29
6.2 Prior to Initial Use .................................................................................................................................. 29
6.3 Mains operation / Charging the Batteries ............................................................................................. 29
6.3.1 Mains Power Failure Alarm ............................................................................................................. 31
6.4 Connections ........................................................................................................................................... 32
6.4.1 Connecting the Patient Cable and Sensor....................................................................................... 32
6.4.2 Disconnecting the Sensor................................................................................................................ 33
6.4.3 Disconnecting the Patient Cable from the Unit .............................................................................. 34
6.5 Installing the Unit................................................................................................................................... 34
6.6 Using Masimo-Sensors........................................................................................................................... 35
6.6.1 Selecting the (correct) Sensor ......................................................................................................... 36
6.6.1.1 Adhesive Sensors...................................................................................................................... 36
6.6.1.2 Reusable Sensors...................................................................................................................... 37
6.6.1.3 Patient Cable............................................................................................................................. 38
6.6.2 Expected lifetimes of patient cables and sensors........................................................................... 38
6.6.2.1 90%-Lifetime or „Near expiration“-message............................................................................ 39
6.6.2.2 Life time exceeded.................................................................................................................... 40
6.7 Using the Interfaces ............................................................................................................................... 42
7 Control.............................................................................................................................................. 43

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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) ........................................................................................................... 48
7.5.1 Setting the Alarm Limits.................................................................................................................. 49
7.5.2 Setting the Alarm Filter ................................................................................................................... 50
7.6 Plethysmogram Display (Pleth-display) ....................................................................................... 52
7.7 Configuration (Configuration)....................................................................................................... 53
7.7.1 Screen options (Screen)............................................................................................................... 53
7.7.1.1 Contrast (Contrast).............................................................................................................. 53
7.7.1.2 Backlight (Backlight)........................................................................................................... 54
7.7.1.3 Menu Language (Language).................................................................................................. 54
7.7.1.4 Access Permissions (Home Mode) .......................................................................................... 55
7.7.2 Acoustical Alarms (Acoust. Alarms) ....................................................................................... 57
7.7.2.1 Pulse Tone Volume (Volume Pulse) ................................................................................... 57
7.7.2.2 Alarm Tone Volume (Volume Alarm).................................................................................. 58
7.7.2.3 Alarm Silence Time (Silence Time) ................................................................................... 59
7.7.3 Masimo Signal Processing (Signalprocessing)...................................................................... 60
7.7.3.1 Averaging Time (Averaging time) .................................................................................... 60
7.7.3.1 Perfusion Sensitivity (Algorithm mode)............................................................................. 61
7.7.3.3 SmartTone (SmartTone)........................................................................................................ 63
7.7.3.4 Artifact Filter (Artifact-Filter)...................................................................................... 63
7.7.4 System Time (Clock)..................................................................................................................... 64

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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)..................................................................................... 68
7.8.3 Alarm Details ................................................................................................................................... 69
7.9 Trend Display (Trend) .......................................................................................................................... 70
7.9.1 Trend Display................................................................................................................................... 70
7.10 Exporting the Data ............................................................................................................................... 71
8 Alarms .............................................................................................................................................. 73
8.1 General................................................................................................................................................... 73
8.2 Alarm Categories.................................................................................................................................... 74
8.2.1 High Priority Alarms ........................................................................................................................ 74
8.2.1.1 SpO2 Alarm ............................................................................................................................... 75
8.2.1.2 Pulse Rate Alarm....................................................................................................................... 75
8.2.1.3 Sensor Alarms........................................................................................................................... 76
8.2.1.4 System Alarms .......................................................................................................................... 77
8.2.2 Medium Priority Alarms .................................................................................................................. 79
8.2.3 Low Priority Alarms ......................................................................................................................... 80
8.3 Status message ...................................................................................................................................... 81
8.4 Battery Alarms ....................................................................................................................................... 82
8.4.1 Battery Alarm (low priority) ............................................................................................................ 83
8.4.2 Battery Alarm (medium priority)..................................................................................................... 83
8.4.3 Battery Alarm (high priority) ........................................................................................................... 83
8.5 Combination of Alarms of Different Priorities ....................................................................................... 83
9 Malfunctions and Troubleshooting .................................................................................................... 84

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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................................................................................................................................................ 92
10.3.1 Cleaning the Unit........................................................................................................................... 92
10.3.2 Cleaning of Masimo-Sensors......................................................................................................... 92
10.3.3 Cleaning of Patient Cables............................................................................................................. 93
10.4 Maintenance........................................................................................................................................ 93
10.4.1 Regular Check................................................................................................................................ 94
10.4.2 User Check of Alarm Function....................................................................................................... 94
11 Accessories and Replacement Parts ................................................................................................. 96
11.1 Accessories........................................................................................................................................... 96
12 Advanced Information..................................................................................................................... 97
12.1 Averaging Time .................................................................................................................................... 97
12.2 Alarm Signal Generation Delay ............................................................................................................ 98
13 Index............................................................................................................................................... 99

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1General
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.
Before beginning all work on the unit, read the operating instructions completely; in particular the chapter
regarding safety and the respective safety notices. The reading must have been understood.
The manual is a component of the unit. It is to be kept accessible at all times in direct proximity of the unit.
The operating instructions must always be passed on with the unit to third parties.
1.2 Symbol Designation
Important technical safety notices in these operating instructions are designated by symbols.
These specified notices on industrial safety must be strictly complied with and adhered to. Behave
cautiously in these cases especially in order to avoid accidents, damages to unit and people.
WARNING! Injury or Mortal Danger!
This symbol marks notices that, if not observed, can lead to health impairments, injuries, lasting
bodily injury or to death.
CAUTION! Electric Shock Hazard!
This symbol draws attention to dangerous situations from electric current. The danger of severe
injury or death exists from not observing the safety notices. Required work may be performed
only by a qualified electrician.
ATTENTION! Risk of Unit Damage!
This symbol designates notices that, if not observed, can lead to damages, malfunctions, and/or
loss of the equipment.
NOTICE!
This symbol designates tips and information that are to be considered for efficient and trouble-free
handling of the unit.

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INFORMATION!
This symbol marks notices to clarify specific specialized terms.
1.3 Liability and Warranty
All data and notices in this operating manual were arranged in consideration of valid regulations, the
current state of the art, as well as our many years of knowledge and experience.
This operating manual must be read carefully before beginning all work on and with the unit! The
manufacturer does not accept liability for damages and malfunctions that result from not observing the
operating instructions.
The German version of these operating instructions is applicable. Translations of the operating instructions
also have been provided to the best of our knowledge. However, we cannot accept liability for translation
errors.
The text and graphic representations do not correspond necessarily to the supply scope. The designs and
diagrams do not correspond to the scale 1:1.
The current supply scope can vary from the presently described data and notices, as well as the graphic
representations due to the use of additional order options with special unit or based on the newest
technical changes. If you have question, please contact the manufacturer.
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.
Product warranties remain valid provided the product was properly installed and used.
Defects, malfunctions, or failures of the warranted product caused by damage resulting from Acts of God
(such as floods, fire, etc.), environmental and atmospheric disturbances other external forces such as
power line disturbances, host computer malfunction, misconnections, and damage caused by misuse,
abuse, and unauthorized alteration or repair, are not warranted.
A product will not be warranted in the following situations:
• The product has been found to be defective after the warranty period has expired.
• The product has been subjected to misuse, abuse, or unauthorized repair, whether by accident or other
cause. Such conditions will be determined by HUM Gesellschaft für Homecare und Medizintechnik mbH at
its sole and unfettered discretion.
• The product is damaged beyond repair due to natural disasters, such as by lightning, flood, earthquake,
etc.

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• 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
months of purchase provided said product was properly installed and used.
For Masimo cables and sensors, the warranty terms of manufacturer Masimo Corp. apply.
1.4 Copyright Protection
The instruction manual is to be kept confidential. It is exclusively intended for active personnel that work
on and with the unit.
All textual data, texts, drawings, illustrations, and other representations are predicted by copyright laws
and are entitled additionally to commercial patent rights. Each abusive use is subject to prosecution.
Transfer to third parties, duplication in any shape or form (also in part), as well as the utilization and/or
reporting of the contents are not permitted without written permission from the manufacturer. Offences
are subject to compensation. Additional rights remain reserved.
We reserve the right to exercise all rights relating to conditional patent rights.
This device is covered by one or more of the following U.S. Patents:
RE38,492, RE38,476, 7,221,971, 7,215,986, 7,215,984, 6,850,787, 6,826,419, 6,822,564, 6,816,741,
6,745,060, 6,699,194, 6,684,090, 6,654,624, 6,650,917, 6,643,53, 6,606,511, 6,501,975, 6,463,311,
6,430,525, 6,360,114, 6,263,222, 6,236,872, 6,229,856, 6,157,850, 6,067,462, 6,011,986, 6,002,952,
5,919,134, 5,769,785, 5,758,644, 5,685,299, 5,632,272, 5,490,505, 5,482,036 and their international
equivalent patents. Other US and international patents are pending.
Possession or purchase of this device does not convey any express or implied license to use the device with
unauthorized sensors or cables, which would, alone, or in combination with this device, fall into the scope
of one or more of the patents relating to this device.
1.5 Removal and Disposal
–Keep the packaging in order to ship the unit intact in case service is required.
Nonetheless, if the packing material should nevertheless be disposed of, the disposal
regulations valid in the respective country are to be followed.

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–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. Therefore, rather than throw the batteries into the domestic refuse, dispose
of them instead at an appropriate collection site.
–If the unit's end of usage stage has been reached, it is to be disposed of according to
the laws. Alternatively, the unit can be returned to the dealer, who then takes over
the professional disposal.