WO2004093665A1 - Procede et dispositif d'enregistrement des incidents de fonctionnement des appareils medicaux - Google Patents
Procede et dispositif d'enregistrement des incidents de fonctionnement des appareils medicaux Download PDFInfo
- Publication number
- WO2004093665A1 WO2004093665A1 PCT/FR2004/000854 FR2004000854W WO2004093665A1 WO 2004093665 A1 WO2004093665 A1 WO 2004093665A1 FR 2004000854 W FR2004000854 W FR 2004000854W WO 2004093665 A1 WO2004093665 A1 WO 2004093665A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- medical device
- incident
- operating
- recording
- parameters
- Prior art date
Links
Classifications
-
- G—PHYSICS
- G07—CHECKING-DEVICES
- G07C—TIME OR ATTENDANCE REGISTERS; REGISTERING OR INDICATING THE WORKING OF MACHINES; GENERATING RANDOM NUMBERS; VOTING OR LOTTERY APPARATUS; ARRANGEMENTS, SYSTEMS OR APPARATUS FOR CHECKING NOT PROVIDED FOR ELSEWHERE
- G07C3/00—Registering or indicating the condition or the working of machines or other apparatus, other than vehicles
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M13/00—Insufflators for therapeutic or disinfectant purposes, i.e. devices for blowing a gas, powder or vapour into the body
- A61M13/003—Blowing gases other than for carrying powders, e.g. for inflating, dilating or rinsing
-
- G—PHYSICS
- G07—CHECKING-DEVICES
- G07C—TIME OR ATTENDANCE REGISTERS; REGISTERING OR INDICATING THE WORKING OF MACHINES; GENERATING RANDOM NUMBERS; VOTING OR LOTTERY APPARATUS; ARRANGEMENTS, SYSTEMS OR APPARATUS FOR CHECKING NOT PROVIDED FOR ELSEWHERE
- G07C3/00—Registering or indicating the condition or the working of machines or other apparatus, other than vehicles
- G07C3/08—Registering or indicating the production of the machine either with or without registering working or idle time
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
- A61B1/012—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor characterised by internal passages or accessories therefor
- A61B1/015—Control of fluid supply or evacuation
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M13/00—Insufflators for therapeutic or disinfectant purposes, i.e. devices for blowing a gas, powder or vapour into the body
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
- A61M16/0051—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes with alarm devices
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
- A61M16/021—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes operated by electrical means
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/142—Pressure infusion, e.g. using pumps
Definitions
- the present invention relates to a method, and a device for implementing this method, for recording operating incidents of medical devices.
- EP 1 010 391 also discloses an interactive monitoring device between two microprocessors for controlling a medical device; this document does not have the direct purpose of recording the incidents of operation of a medical device.
- the present invention aims to provide such a system, to overcome the difficulties currently encountered, and exposed above.
- the invention firstly relates to a method for recording the operating incidents of a medical device, constituted by a medical insufflator, this method essentially consisting of measuring, monitoring and permanently recording operating parameters of the device.
- the medical device concerned in particular the dynamic or static pressure, by storing the measured parameters over a predetermined number of the last operating cycles of the apparatus or over a "sliding" period of operation of a predefined duration of this apparatus, and case of detection of an operating incident, to keep in memory the data recorded at the time of the occurrence of this incident, and, in case of detection of an operating incident, to keep in memory the data recorded at the time of the occurrence of this incident, the recorded data for a period extending before and after the occurrence of the incident, the method also comprising, during the commissioning of the medical device concerned, a detection of possible malfunctions of components of this device, and the recording of detected failures of components. Depending on the type of component malfunction detected, it can be reported to the user and / or order a temporary or permanent prohibition of the medical device
- the method of recording operating incidents of medical devices makes it possible to put under surveillance two types of events, namely:
- the user may possibly be opposed to the fact that he has not made any corrective action, whereas a component failure has been reported, especially if the memorized date of this failure and its report is much earlier than the date, also stored, of the incident detected and reported to the AFSSAPS.
- the recordings of failures and incidents made may " provide for each medical device or category of medical devices concerned, analysis and knowledge necessary for the evolution of these devices and their software, in the sense of an improvement in their operation and reliability.
- a particularly advantageous aspect of the method which is the subject of the invention is that it ensures, after the start of the medical device concerned, a permanent storage of the only information concerning anomalies of certain parameters, in particular the information which precedes and immediately follows all incident, and which correspond to a duration of a few seconds or a few tens of seconds, which makes it possible to limit the size of the memories while benefiting from a maximum of useful information, the information considered as "normal" not being kept in memory.
- the subject of the invention is also a device for implementing the method for recording medical device operating incidents previously defined, which essentially comprises electronic means for measuring the operating parameters of the medical device concerned, in particular relationship with a storage unit provided for, on the one hand, "sliding" the parameters measured over a predetermined number of last cycles or on a predefined operating time of the medical device and, on the other hand, memorizing permanently the data acquired at the time of the occurrence of an incident, the device further comprising means for testing the components of the medical device concerned, in connection with means for signaling component failures, and with the unit memory, also provided for recording the failures of the components.
- This storage unit can be of any known type: so-called "EPROM” memory, hard disk, magnetic tape, etc.
- the device stores the operating parameters measured over the last operating cycles of the medical device concerned, for example over three to ten cycles, which represents a permanent monitoring over a "sliding" period of at least 10 to 30 hours. seconds.
- operating cycle is meant a series of phases of physical measurement of output data of the medical device, such as dynamic pressure, static pressure, pressure drop, flow rate, speed, voltage, intensity, etc., and calculation of control parameters of the medical device in order to reach the set values of the different outputs, followed by the application of the new calculated parameters.
- the stored data will be all the measurement and parameterization information of the medical device concerned.
- the values representative of the parameterization of the medical device and the physical output values of the same medical device are fixed in a part of the storage unit which is only accessible to the manufacturer or to accredited inspection bodies, to be noted preferably in the context of contradictory expertise.
- the normal functioning of the medical device can only be controlled after the preliminary tests of the components have been carried out, and in the event of a malfunction of an essential component, the device can not be operated in principle. However, in order to take account of certain random or fugitive failures, the medical device may restart after switching off and on again, provided of course that, during repeated tests during this power-up, no component failure is found. . However, such a situation will remain stored in the device, which will thus keep track.
- the storage unit then intervenes to record any operating incidents, that is to say to store the data present just before and just after the moment of occurrence of an operating incident, which also triggers a problem. alarm and / or causes the shutdown of the medical device, with or without counter-effect.
- the data recorded and analyzed here are variable values associated with each parameterization of the device of control of the medical device / values established during sequences which generally represent times equal to or less than one second.
- an analysis period of at least 10 seconds is in practice necessary. period extending before and after the occurrence of the incident. This involves, for example, recording the parameters of the five cycles that precede the appearance of an alarm, and also the parameters of the five cycles that follow the appearance of the alarm. This recording must also be dated, with appropriate precision, of the order of one second.
- the storage unit of the device of the invention must be able to manage a minimum number of recordings of dated incidents, which may occur successively, for example ten recordings, in order to keep track of these incidents, even if the practitioner deems it essential and safe to continue his intervention, without interrupting the operation of the medical device.
- the device stores in particular, in association with the temporal data (date):
- the number of cycles recorded before and after each incident can be modified and adapted to each application case, in order to offer a better analysis relevance.
- insufflator for diagnostic and surgical endoscopy, which includes a circuit for insufflating a neutral gas such as carbon dioxide in an operating cavity, a controlled proportional flow rate controlled pneumatic valve being provided on this circuit, this valve being electrically powered.
- Means for measuring the insufflation pressure are provided at the head of the insufflation circuit, and the intracavitary pressure is calculated from the measured insufflation pressure, by means of an evaluation of the pressure loss of the circuit.
- FIG. 1 is a diagram of the pressures as a function of time
- the operation of this insufflator comprises an alternation of insufflation time, with measurement of dynamic pressure, and rest time, with measurement of a static or intracavitary pressure, to be compared with the set pressure.
- the insufflation time itself is subdivided into a succession of partial times, with increasing flow rates, until a dynamic pressure value equal to the setpoint pressure increased by an amount " ⁇ p" is reached.
- k which is a numerical control factor of the electric voltage applied to the proportional pneumatic valve of the insufflator, this coefficient being determined at points 1, 2 and 3 (it is zero at points A, B and C) ;
- the instantaneous pressure P and flow D, measured at each parameterization of the coefficient k, are kept in "sliding" memory for the last three parameterizations of this coefficient k.
- the closing of the valve after de-airing causes the storage "frozen" of the characterizing values and the operating parameters for the three last cycles before stopping the insufflation, as well as values of the instantaneous pressures after stopping the insufflation, when opening the valve and closing it.
- FIG. 2 illustrates the general operating loop of the insufflator.
- the flowchart of FIG. 3 illustrates the test and calibration loop carried out before commissioning the insufflator. This involves testing all the functions, and acquiring various data, such as the voltage values (or the value of the aforementioned coefficient k) at the opening of the valve and at the closing of this valve, as well as the values of the operating hysteresis curve of said valve. It is also a question of calibrating the measuring points of the pressure P and of the flow D.
- This flow diagram indicates how, in the initialization phase, the observation of failures of essential components causes the non-starting of the insufflator, and the memorization of the malfunctions, accompanied by an error message.
- the flowchart of FIG. 4 illustrates the regulator phase of the insufflator, in its normal operating cycle.
- Smoothed refers to the smoothed value of six pressure measurements taken at intervals of 0.15 seconds (in this example - see also Figure 1).
- FIG. 5 illustrates the phase of measurement and storage of the operating incidents, for one of the parameters monitored, "measurement 1" denoting here the instantaneous pressure (measured at the six points 1, 2, 3, A, B, C, as indicated above).
- delta 1 means the permissible overpressure before alarm, variable for example from 5 to 10 mm Hg;
Landscapes
- Health & Medical Sciences (AREA)
- General Physics & Mathematics (AREA)
- Physics & Mathematics (AREA)
- Heart & Thoracic Surgery (AREA)
- Biomedical Technology (AREA)
- Hematology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Anesthesiology (AREA)
- Engineering & Computer Science (AREA)
- Measuring And Recording Apparatus For Diagnosis (AREA)
- Medical Treatment And Welfare Office Work (AREA)
- Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
Abstract
Description
Claims
Priority Applications (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US10/553,409 US20070073493A1 (en) | 2003-04-16 | 2004-04-06 | Method and device for recording operating incidents of medical instruments |
JP2006505782A JP2006523483A (ja) | 2003-04-16 | 2004-04-06 | 医療機器の操作上の問題を記録するための方法とその装置 |
EP04742444A EP1624789A1 (fr) | 2003-04-16 | 2004-04-06 | Procede et dispositif d'enregistrement des incidents de fonctionnement des appareils medicaux |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
FR0304765A FR2853980B1 (fr) | 2003-04-16 | 2003-04-16 | Procede et dispositif d'enregistrement des incidents de fonctionnement des appareils medicaux |
FR03/04765 | 2003-04-16 |
Publications (1)
Publication Number | Publication Date |
---|---|
WO2004093665A1 true WO2004093665A1 (fr) | 2004-11-04 |
Family
ID=33041912
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/FR2004/000854 WO2004093665A1 (fr) | 2003-04-16 | 2004-04-06 | Procede et dispositif d'enregistrement des incidents de fonctionnement des appareils medicaux |
Country Status (6)
Country | Link |
---|---|
US (1) | US20070073493A1 (fr) |
EP (1) | EP1624789A1 (fr) |
JP (1) | JP2006523483A (fr) |
CN (1) | CN1816302A (fr) |
FR (1) | FR2853980B1 (fr) |
WO (1) | WO2004093665A1 (fr) |
Families Citing this family (9)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP4708368B2 (ja) * | 2005-01-19 | 2011-06-22 | オリンパス株式会社 | 手術データ管理装置 |
US20080221590A1 (en) * | 2007-03-05 | 2008-09-11 | Intuitive Surgical, Inc. | Apparatus for positioning and holding in place a manually manipulated medical device during the performance of a robotically assisted medical procedure |
US8560124B2 (en) * | 2007-07-13 | 2013-10-15 | Cummins Inc. | Idle control system and method for adaptive temperature control |
US8717181B2 (en) | 2010-07-29 | 2014-05-06 | Hill-Rom Services, Inc. | Bed exit alert silence with automatic re-enable |
WO2012095764A1 (fr) * | 2011-01-14 | 2012-07-19 | Koninklijke Philips Electronics N.V. | Mesure de la continuité d'une thérapie associée à un dispositif de traitement respiratoire |
US8840077B2 (en) | 2011-08-24 | 2014-09-23 | Coopersurgical, Inc. | Table-mounted surgical instrument stabilizers |
CN103295275A (zh) * | 2012-03-05 | 2013-09-11 | 联想(北京)有限公司 | 一种工作参数记录方法及装置 |
CN105306666A (zh) * | 2014-12-26 | 2016-02-03 | 维沃移动通信有限公司 | 移动终端的控制方法及移动终端 |
KR102437404B1 (ko) | 2016-07-14 | 2022-08-30 | 인튜어티브 서지컬 오퍼레이션즈 인코포레이티드 | 수술 기구를 제어하는 시스템 및 방법 |
Citations (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US5438510A (en) * | 1993-03-03 | 1995-08-01 | Deka Products Limited Partnership | User interface and monitoring functions for automated peritoneal dialysis systems |
DE19518621A1 (de) * | 1995-05-24 | 1996-11-28 | Dantschke Medizintechnik | Einrichtung zur Überwachung der Betriebszustände von Endoskopen |
US5629871A (en) * | 1995-06-07 | 1997-05-13 | Cobe Laboratories, Inc. | Wear trend analysis technique for components of a dialysis machine |
WO1999046593A1 (fr) * | 1998-03-10 | 1999-09-16 | Baxter International Inc. | Systemes et procedes pour surveiller et analyser le fonctionnement de dispositifs medicaux de traitement |
Family Cites Families (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
KR100287267B1 (ko) * | 1993-01-07 | 2001-12-28 | 이데이 노부유끼 | 자기디스크 |
US5678568A (en) * | 1993-07-27 | 1997-10-21 | Olympus Optical Co., Ltd. | System control apparatus, medical system control apparatus and image-plane display method of medical system control apparatus |
-
2003
- 2003-04-16 FR FR0304765A patent/FR2853980B1/fr not_active Expired - Lifetime
-
2004
- 2004-04-06 JP JP2006505782A patent/JP2006523483A/ja active Pending
- 2004-04-06 WO PCT/FR2004/000854 patent/WO2004093665A1/fr not_active Application Discontinuation
- 2004-04-06 CN CNA2004800100767A patent/CN1816302A/zh active Pending
- 2004-04-06 EP EP04742444A patent/EP1624789A1/fr not_active Withdrawn
- 2004-04-06 US US10/553,409 patent/US20070073493A1/en not_active Abandoned
Patent Citations (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US5438510A (en) * | 1993-03-03 | 1995-08-01 | Deka Products Limited Partnership | User interface and monitoring functions for automated peritoneal dialysis systems |
DE19518621A1 (de) * | 1995-05-24 | 1996-11-28 | Dantschke Medizintechnik | Einrichtung zur Überwachung der Betriebszustände von Endoskopen |
US5629871A (en) * | 1995-06-07 | 1997-05-13 | Cobe Laboratories, Inc. | Wear trend analysis technique for components of a dialysis machine |
WO1999046593A1 (fr) * | 1998-03-10 | 1999-09-16 | Baxter International Inc. | Systemes et procedes pour surveiller et analyser le fonctionnement de dispositifs medicaux de traitement |
Also Published As
Publication number | Publication date |
---|---|
EP1624789A1 (fr) | 2006-02-15 |
JP2006523483A (ja) | 2006-10-19 |
FR2853980A1 (fr) | 2004-10-22 |
CN1816302A (zh) | 2006-08-09 |
US20070073493A1 (en) | 2007-03-29 |
FR2853980B1 (fr) | 2005-08-26 |
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