カタログ資料等
- How to Respond to FDA 483 Warning Letters (pdf, 564KB)
- Comment remplir (et éviter) un formulaire 483 de la FDA (pdf, 534KB)
- Wie-reagiere-ich-auf-und-vermeide-Formblatt-483-der-FDA? (pdf, 566KB)
- ヴァイサラライフサイエンス 環境モニタリングシステム参入 (pdf, 1335KB)
- 如何应对（和避免）美国食品药品监督管理局 （FDA）的483检查表 (pdf, 793KB)
- Vaisala Veriteq Continuous Monitoring System Brochure (pdf, 1449KB)
- Vaisala Veriteq CMS Service and Support Plans - North America (pdf, 190KB)
- Measure Monitor and Validate in Life Science Environments (pdf, 456KB)
- Dienstleistungs- & Supportangebote für Vaisala Veriteq Überwachungs- und Validierungssysteme (pdf, 431KB)
- Mesurer, assurerle monitoring & valider dans les environnements des sciences de la vie (pdf, 509KB)
- Vaisala Veriteq Datalogger 10 Minute Installation Guide (pdf, 555KB)
- Vaisala Veriteq Continuous Monitoring System IT FAQ (pdf, 153KB)
- viewLinc_3-6_Quick_Start_Guide (pdf, 3659KB)
- 配有网络设备的 viewLinc 3.6快速入门指南 (pdf, 3462KB)
- Guide de démarrage rapide pour viewLinc 3.6 avec des périphériques en réseau (pdf, 1111KB)
- ネットワークデバイスを活用する際のviewLinc3.6クイック スタート ガイド (pdf, 3606KB)
- viewLinc 4.0 Quick Start (pdf, 3233KB)
- Digi Software and Drivers (zip, 2929KB)
- Success Story: Medical Surgical Supply Company Increases Compliance (pdf, 2447KB)
- Lagerüberwachung: Unternehmen für medizinischchirurgisches chirurgisches (pdf, 347KB)
- viewLinc-3-6-IQOQ-sample (pdf, 348KB)
- viewLinc-3.6-ReleaseNotes (txt, 49KB)
- viewLinc-3.6.0.398-Errata (pdf, 96KB)
- Vaisala Veriteq kontinuierliches Überwachungssystem – Konfigurationsmöglichkeiten (pdf, 999KB)
- CMS-Common-Configurations-EN (pdf, 972KB)
- Configurations habituelles du Système de surveillance en continu (pdf, 1000KB)
- Setting up Digi Connect Wi-SP or ConnectPort TS W Devices with viewLinc (pdf, 109KB)
- Installing viewLinc with Digi Devices across Subnets (pdf, 29KB)
- viewLinc 3.6 Admin Guide (pdf, 3143KB)
- viewLinc 3.6 User Guide (pdf, 1339KB)
- 管理员指南-viewLinc-3.6 (pdf, 1290KB)
- 用户指南-viewLinc-3.6 (pdf, 460KB)
- Guide de L'Adminisrateur viewLinc 3.6 (pdf, 1551KB)
- GUIDE DE L'UTILISATEUR viewLinc 3.6 (pdf, 1032KB)
- 管理者ガイドviewlinc-3.6 (pdf, 1273KB)
- ユーザーガイドヴァイサラveriteq viewLinc 3.6 ソフトウェア (pdf, 398KB)
- viewLinc 4.0 Admin Guide (pdf, 2323KB)
- viewLinc 4.0 User Guide (pdf, 668KB)
- Vaisala Veriteq Validation system 21 CFR Part 11 compliance (pdf, 267KB)
- Switching From Chart Recorders to Data Loggers (pdf, 131KB)
- Vaisala Veriteq Monitoring System 21 CFR Part 11 Compliance White Paper (pdf, 242KB)
- LSH Independent Monitoring White Paper (pdf, 179KB)
- Monitoring-Systems-Sorting-Out-Wireless (pdf, 6129KB)
- 9 Things you need to know about Continuous Monitoring Systems in FDA-Regulated Environments (pdf, 1363KB)
- Systèmes de monitoring: démystifier le sans fil (pdf, 2210KB)
- Überwachungssysteme: Drahtlos vernetzt (pdf, 1276KB)
- 监测系统 - 无线方案甄选 (pdf, 2340KB)
- モニタリングシステム/ワイヤレスの選定 (pdf, 2733KB)
- 对于FDA监管环境中的连续监测系统，您需要了解的九件事 (pdf, 1107KB)
DigiによるviewLincのインストール
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このページでは、viewLincシステムの設定プロセスを順序立てて説明しています。表示される手順に従ってインストールを行ってください。
- クイックスタートガイド（Quick Start Guide）をダウンロードしてください。
このクイックスタートの文書には、Digi One SP向けのインストラクションが記されています。すでにDigi One SPをお持ちの場合には、クイックスタートガイドがあれば、DigiソフトウェアとviewLincのインストールができます。
もしDigi One SP以外のDigiをお持ちの場合には、後述する他のDigiモデル向けのインストラクションに従ってください。
クイックスタートガイドの各手順は、インストールしようとする各Digiデバイスで繰り返し行う必要があります。viewLincをインストールする前に、すべてのDigiデバイスをインストールすることをお勧めします。
もし、下記のいずれかに相当する場合には、追加的なインストラクションが必要になります。クイックスタートガイドに従う前にこちらのインストラクションを読んでください。追加的なインストラクションはすべて、クイックスタートの各ステップを参照しているのでクイックスタートガイドも手元に準備してください。
Lost your Digi Configuration CD - see FAQ tab.
You Must Use DHCP (can't assign static IP for Digi Device) - see FAQ tab.
Using Digi PortServer TS 1, 2, 4, 8 or 16 - see FAQ tab.
Installing Digi on Different Subnet
上記の内の適切なインストラクションを読み、さらに（あるいは）これらの追加的条件が当てはまらない場合には、以下のインストラクションに従ってください。
Digiデバイスのネットワーク接続
クイックスタートガイドの手順1を実行してください。
Digiデバイスの設定とDigi Driverのインストール
クイックスタートガイドの手順2のパートA～Cを実行してください。 もし、何らかの理由で、クイックスタートガイド（手順2のパートC）が推奨するように「このコンピュータにDigi RealPortをインストールする（Install Digi RealPort on this computer）」のチェックボックスが選択されない場合には、Digi RealPort Driverをインストールする手順を経る必要があります。 Digi RealPort Driverをインストールする方法（パートDの一部と考えてください）： - 「Digi Device Servers」の画面を開いて、「SOFTWARE」をクリックしてください。
- Real Port Driverをインストールしてください。
- Digi Real Portセットアップウィザードの「Welcome」画面を開いて、「NEXT」をクリックしてください。
- 使用するデバイスを選択して、「NEXT」をクリックしてください。
- Digi Real Portセットアップウィザードを開いて、Digiとの対話に使用するコンピュータのCOMポートを選択してください。その際にCOMポートの対立を回避するため、COM 10またはそれ以上を使用してください。このCOMポート名を書き留めておいてください。
- 「NEXT」をクリックし、さらに「FINISH」をクリックしてください。
Veriteqソフトウェアのインストール
クイックスタートガイドの手順3以降を実行してください。
ご不明な点は、ヴァイサラサポートまでお問い合わせください。 |
FAQ
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How do I uninstall a Vaisala Veriteq USB Logger Cable? » To uninstall the Vaisala Veriteq USB Logger Cable, please go to Add or Remove Programs in Windows, find FTDI USB Serial Converter Drivers and click the Change/Remove button. Follow the uninstall wizard as prompted to complete the uninstallation.
Notice for Windows XP users:
If you are experiencing problems uninstalling the cable on Windows XP, this may be due to changes made by a Microsoft Update (KB923191). To correct this problem, please follow the directions below:
- Navigate to C:\Windows\system32
- Locate the ftdiunin.exe file
- Right-click the file and select Properties
- Select the Compatibility tab
- In the Compatibility mode section, place a check in the Run this program in compatibility mode for: box
- Select Windows 2000 from the drop-down list
- Click OK
- Go back to Add or Remove Programs and attempt to uninstall again
If you are still unsuccessful, please contact Technical Support.
How do the FDA CFR 21 Part 11 requirements relate to the VL Data Logger system? » The CFR 21 Part 11 regulations apply to any electronic records that are used as a part of GMP documentation, including the ones produced by the Vaisala VL-series data logging system.
CFR 21 Part 11 Requirement |
Reference |
VL-Series Features |
| All records shall be prepared, dated and signed (full signature, handwritten) by one person and independently checked, dated and signed by a second person. |
GMP 211.186 |
Password-protected system outputs paper-based records with appropriate form for review and approval sign-offs. |
| Electronic records may be considered trustworthy and reliable and be used in lieu of paper records provided that the electronic records have proper security controls |
CFR 21 Part 11; Subpart A-Sec 11.1 Scope |
Software produces secure and encrypted electronic records that are used to produce printed documentation. Software recognizes invalid or altered data logger files and renders them unusable |
| Ensure the authenticity and integrity of the electronic records such that the person responsible for the electronic record cannot readily repudiate the record as not genuine |
CFR 21 Part 11; Subpart B-Sec. 11.10 |
Tamper-proof data logger (no switches or buttons). Password-protected calibration record verifies integrity of recorded data. Password protection ensures that person who created electronic record is the same person who outputs a paper record |
| Ensure that the system can discern invalid or altered electronic records |
CFR 21 Part 11; Subpart B; Sec. 11.10 (a) |
Software recognizes invalid or altered data logger files and renders them unusable |
| Ensure that complete and accurate records in both human readable and electronic form are available for review and inspection by the FDA |
CFR 21 Part 11; Subpart B; Sec. 11.10 (b) |
Original raw electronic record is never modified and can be printed for review and inspection |
How does the Continuous Monitoring System and VL data loggers produce GMP-compliant records? » The VL-series data logging system is a set of monitoring tools that have been designed for use within the framework of a company's GMP-compliant record-keeping and documentation system. The system produces paper-based data logging records that, after signed review and approval by responsible parties, can be used in a GMP-compliant documentation package. As a part of this process, the VL-series system creates and uses secure and unalterable electronic records consistent with GMP requirements for authenticity and accuracy.
How long can Vaisala Veriteq data loggers record for? »
The length of time Vaisala data loggers can record for is determined by the number of input channels enabled on the logger, the recording frequency (sampling interval), and the size of the memory (32K or optional 105K).
Vaisala data loggers can, for example, record data continuously for 10 years (at a typical sampling rate of once per minute) without any need for a battery replacement. For a typical two-channel data logger that's over 10 million non-stop readings.
For a general guide, refer to the Sample Interval & Duration Chart or refer to the specifications page for the specific data logger model you are interested in.
How do I run an External Digital Relay I/O device as part of my viewLinc alarm system? » In addition to email alarms and pop up windows, you can also run commands on the viewLinc Server machine (which in turn can trigger external devices) when an alarm threshold is exceeded.
To configure these:
In the Advanced area of the Edit Thresholds Settings screen, enter a DOS command in the appropriate box. There are different boxes to accept different commands for when an alarm is triggered, notification is repeated, alarm acknowledged, or alarm condition is no longer true.
You may be using a B+B Electronics External Digital Relay I/O Device. This device allows you to turn on two different devices (or both at the same time) if these devices are correctly wired to both power and the Digital Relay Device itself.
You must also attach the Digital Relay I/O Device to a COM port on the viewLinc Server.
The specific DOS command to enter in the viewLinc Edit Threshold Settings screen in viewLinc 3.0 when using the B+B External Digital Relay I/O device and the python SwitchBbRelay script (installed automatically as part of viewLinc 3.0) is:
python SwitchBbRelay.pyc <COM port to which the relay device is attached> <Option> where Option is one of:
1 – turn on Device 1
2 – turn on Device 2
3 – turn on both Device 1 and 2
0 – turn off both Devices. How do I stop communication alarms? » 1. Ensure your loggers are plugged in.
2. Ensure your Digi is connected to a power supply and the power supply is plugged in. The light on the front of the Digi should be solid red.
3. Ensure the Digi is connected to and communicating with the network. Try to ping the Digi by typing the following at a command prompt: ping <IP address of the Digi>.
4. If there is communication between the Digi and the network, check that the Verieq-supplied cable connecting the logger to the Digi is functioning properly. When the cable is functioning properly, the light should be mostly off with an occasional flicker. If the light on the cable is solid red, there is a problem with the logger cable or logger. See step 6.
5. If the light on the cable is working correctly but you are still getting communication alarms, go into Device Manager on the viewLinc Host computer and ensure the Digi is still installed. Under the Ports category in Device Manager, you should see an entry for Digi SP One. If you don’t see this, reinstall the Digi by following steps 2 B and C from the Quick Start Guide for viewLinc with Digi Devices.
6. If the light on the cable is not working properly, open a graphing application (vLog or Spectrum) and determine if the logger can communicate with the graphing application. If there is a problem with the logger communicating with the graphing application, it is likely the logger or logger cable is not functioning properly. Try connecting a new logger – or a logger that is known to be working – and see if you can connect to it in vLog or Spectrum.
Which COM ports is my Digi device using? » There are two easy ways you can check to see which COM ports are associated with which Digi Device. Both include accessing the Device Manager in Windows.
Open Device Manager (From Start, choose Settings, Control Panel, Administrative Tools, Computer Management. Device Manager is on the left hand side).
Once Device Manager is open, click on Ports (COM & LPT) to see which COM ports are connected to which devices. (The Digi Devices should be named Digi xxxxx (where X is the model of the Digi).
The next option (for more detail), is to go to Device Manager (Start, Settings, Control Panel, Administrative Tools, Computer Management, Device Manager is located on the left hand side), and, under Multiport serial adapters, right-click the device in question. Choose Properties, select the Advanced tab, click on the properties button. On the left will be a list of the COM ports used for this device.
What if I cannot communicate with the logger(s) connected to my Digi device? » If you cannot communicate with loggers attached to a Digi device using Vaisala Veriteq software, there may be a problem with the way the Digi is configured.
Please check the folowing, retesting communication after each step:
- The Digi device is plugged in to your network and powered on;
- A logger is attached to the Digi device;
- The RealPort driver has been installed. There should be a listing for a Multiport Serial Adaptor with the IP address of your device in Device Manager. There should be a listing for one or more Digi RealPorts under the Ports (COM & LPT) heading in Device Manager. If the driver has not been installed, perform step 5 on the Digi Setup Page (see instructions for viewLinc)
Make sure the Veriteq software is configured to communicate with the correct COM port (see the Ports (COM & LPT) section in Device Manager). In Spectrum or vLog go to Tools>Options and select the correct COM port from the drop-down menu.
If things still don't work, reconfigure the Digi device using the instructions below:
1.Enter the IP address of the device into a web browser
2.Enter the username and password at the login screen (the defaults are root and dbps).
3.Once you are logged in, click on the Setup Wizards link
4.Click on the RealPort link
5.Follow the wizard, enabling RealPort and NOT enabling Altpin
6.Click on the Admin link
7.Click on the Reboot link and follow the wizard to reboot
If you still cannot communicate with the logger, it may be due to a problem with the RealPort driver installation. During the installation there is a step that asks you to enter the number of serial ports. This refers to the number of physical ports on the Digi device, not the COM port number that you want to allocate to the device (eg. for a Digi One RealPort you would enter 1, for a Digi PortServer TS4 you would enter 4). If the incorrect number is entered here, it is quite likely that you will not be able to communicate with a logger attached to the device.
To fix this problem, uninstall the drivers by right-clicking the listing for Multiport Serial Adaptor in Device Manager and selecting Uninstall. One the uninstall is complete, reinstall the driver ensuring that you specify the correct number of ports. What if the Digi Setup Wizard cannot save settings to the Digi device? » When going through the Digi Setup Wizard, if the you get a message stating that it cannot save the settings to the device even though the device is visible in the discovery portion of setup (and also responds to a ping), then it might be a problem with proxy settings on the your internet connection. This might also prevent you from logging in to the device's web interface.
One way to check if you connect to the Internet through a proxy server:
1.In Internet Explorer, go to Tools>Internet Oprtions
2.Click on the Connections tab
3.Click on the LAN Settings button
4.See if there is a check mark in Proxy Server box
If you are using a Proxy Server, you may have to add exceptions for the IPs that the Digi devices are using. Here's how to do that:
1.Click on the Advanced button in the Proxy Server section of the window opened above
2.Enter the IP addresses of the Digi devices in the Exceptions box
3.Click OK on all of the windows until you get back to the browser
Once this is done, try to log into the Digi's web configuration utility (by entering the IP address into a browser).
If you are able to log in (the default username / password is root / dbps), then configuration can be done through this interface as below:
1.Click on the Setup Wizards link
2.Click on the RealPort link
3.Follow the wizard, enabling RealPort and NOT enabling Altpin
4.Click on the Admin link
5.Click on the Reboot link and follow the wizard to reboot
The Digi device is now configured. The RealPort driver has not been installed yet, so do not forget this step. To install the RealPort Driver, perform step 5 on the Digi Setup Page (see Vaisala Veriteq CMS Installation Quick Start Guide). These steps must be repeated for each Digi device.
What if the Digi Setup Wizard does not see my Digi devices? » The Windows XP firewall will often block IP addresses that it does not recognize. When installing a Digi device, if the Setup Wizard fails to find a device that is known to be attached to the network, it is possible that the firewall of the local computer is blocking access to this IP address. To test if this is the problem, simply disable the firewall by following these steps:
1.Right-click My Network Places and select Properties
2.Right-click Local Area Connection and select Properties
3.On the Advanced tab, click the Windows firewall button
4.Disable the firewall and click OK
Once the firewall has been disabled, try to run the Setup Wizard again. If it discovers your device then the XP firewall was the problem. Complete the rest of the wizard to finish installing your device. The firewall can be re-enabled after the Digi device has been installed. How does viewLinc know which Digi devices (with attached loggers) are assigned to it? » It doesn't. Digi devices aren't 'assigned' to viewLinc; rather, viewLinc monitors the network for loggers attached to COM ports. As mentioned, viewLinc software communicates via COM ports. Installing a Digi device using the Quick Start Guide creates virtual COM ports which are monitored by viewLinc.
To see which COM ports are assigned to specific Digi devices, use Device Manager:
Open Device Manager (From Start, choose Settings, Control Panel, Administrative Tools, Computer Management. Device Manager is on the left hand side).
Once Device Manager is open, click on Ports (COM & LPT) to see which COM ports are connected to which devices. (The Digi Devices should be named Digi xxxxx (where X is the model of the Digi).
For more detail, in Device Manager, under Multiport serial adapters, right-click the device in question. Choose Properties, select the Advanced tab, and click on the properties button. On the left will be a list of the COM ports used for this device.
To see which loggers are being controlled by viewLinc, see the System tab. How do you add IP addresses for Vaisala Veriteq data loggers? » You don't. But, you do assign IP addresses to Digi devices. Because viewLinc communicates using COM ports, attaching data loggers to the network using Ethernet/IP addresses requires the use of a Digi networking device.
Digi devices create virtual COM ports that allow data loggers to communicate with viewLinc using Ethernet. Digi devices should be configured with static IP addresses, which should be obtained from your IT department prior to installing the Digis and viewLinc.
IP addresses are assigned to Digi devices during Digi driver installation.
Refer to the Vaisala Veriteq viewLinc Quick Start Guide for Digi devices for installation instructions. For more about Digis, see www.digi.com. How do I move my Digi from one location to another (same subnet)? » If you've used a static IP address for your Digi (as recommended) and are moving your Digi to from one location to another within the same subnet, here are the steps to follow:
1. Shut down all Vaisala Veriteq software, if desired. (You may experience communication alarms while performing these steps if you don’t shut down viewLinc).
NOTE: You do NOT need to uninstall the Digi software from the viewLinc Server. In fact, doing so will potentially cause problems when you reattach the Digi to the network.
2. Move the Digi to another location.
3. Plug the Digi into the network again.
4. Restart Veriteq software. viewLinc should be connecting to the Digi and see the loggers.
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