Technical Service Bulletin · Tel: 1-800-535-6663 Fax: 1-315-685-3361 Date: 2014-05-27 SAP DIR #: 20013764 THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION It can be distributed or

THIS INFORMATION IS THE PROPERTY OF WELCH ALLYN, INC. AND AS SUCH SHALL NOT BE REPRODUCED, COPIED, OR USED AS A BASIS FOR THE MANUFACTURE OR SALE OF EQUIPMENT OR DEVICES WITHOUT THE EXPRESS WRITTEN PERMISSION OF WELCH

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20013764C TSB-CVSM 2.20.00 RELEASE MPD FCD-1482 Rev 6 Page 1 of 13

Technical Service Bulletin

PATIENT MONITORS

Welch Allyn, Inc.®

4341 State Street Road

Skaneateles Falls, New York 13153-0220 USA

Bulletin Type: INFORMATION ONLY

Manufacturer: Welch Allyn

Tel: 1-800-535-6663 Fax: 1-315-685-3361 www.WelchAllyn.com

Date: 2014-05-27 SAP DIR #: 20013764

THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION

It can be distributed or made available to only those individuals, companies, and organizations which have current Welch Allyn Confidentiality Agreements, and have a need to know.

Subject: TSB-CVSM 2.20.00 RELEASE

Distribution Scope:

Welch Allyn Global Technical Support, Product, Field & Customer Service teams and WA ASP's

Product(s) Referenced:

CVSM – Connex Vital Signs Monitor

SW Version: 2.20.00

Serial No. / Lot Code:

Production will run concurrently with 1.71.03 devices, both versions of the device will have similar serial numbers requiring reference to the device’s equipment record to determine the software version it was built with.

Summary: CVSM 2.20.00 is a scheduled maintenance release, to address anomalies from prior releases and add feature enhancements including; new bed exit alarm melody, customer-defined custom scores and information messages, remote configuration upgrade, EarlySense* modular solution, and patient rest mode. CVSM 2.20.00 is being released concurrently with Connex CS 1.6, service monitor 1.2, and Service Dashboard 2.0 as some of the new functionality is interdependent.

*EarlySense is only available in the US, Canada, Australia, and New Zealand

Issue: CVSM 2.20.00 offers improvements to existing functionality while adding new features and resolving minor anomalies from earlier releases. The DFU and Service Manual have been updated to document the new features and functionality. A new CVSM model with the EarlySense modular solution (ES-Safety), which offers only the patient motion parameter is introduced. An additional license will be required to allow ES-Safety customers to enable pulse and respiration to be measured by the EarlySense module.

A brief summary of feature enhancements, new features, and resolved anomalies is provided below, along with a list of remaining known issues.


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Feature Enhancements:

• CR 49173 - Moved profile naming to Advanced Settings, which will prevent users from inadvertently changing profile names. Profile names may now be changed in Advanced Settings>General>Device tab.

• CR 50256 - Location and asset ID tag are now part of the permanent configuration settings to prevent them from being replaced when loading a configuration file using remote configuration delivery.

• CR 49707 - Added logging of EtCO2 & IPI alarms to be consistent with logging of parameter alarms for BP, Temp, SPO2.

• CR 52041 - Changed method for converting integers to floats to improve resolution associated with entries for custom modifiers using decimals out to the hundredths place.

• CR 37577 - When entering the passwords, characters are displayed momentarily before turning to asterisks to better aid correct entry.

• CR 39617 - Added NRS IP address field to all options.

• CR 49360 - Log flood message suppression is turned off for the HP-RadTCP (radio host-proxy), NRMGR (nw rendezvous manager), and CONMGR (connectivity manager) subsystems to aide in troubleshooting.

• CR 49384 - Revert the CVSM 2.0 change to auto save on alarm feature in the Intervals Monitoring profile to its pre CVSM 2.0 behavior. The auto save on alarm will only occur when timed intervals are running.

• CR 49772 – Added support for HIS Ids in list types and free text types when using custom data.

• CR 50176 – The pause dialog now allows the clinician to extend the duration of the Pause timer to the needs of the patient or activity for which they would like to pause the continuous monitoring.

New Features:

• CR 39990 - New Bed Exit Alarm Tone. The bed exit alarm tone has been changed to support easier identification of this alarm condition against the other physiological alarm melody.

• CR 32257 - Custom Calculations (Custom Scoring). When configured to the facility’s protocol, the device is capable of supporting single parameter or aggregate parameter scoring systems used for providing decision support information on early signs of patient deterioration. Logging has been updated to log the UI press of the “OK” button in the custom calculations summary window where user is presented with any custom scoring and custom messages generated. Custom scoring requires the creation of a custom data file to add the customers scoring system to the device. For CVSM 2.20.00 all custom data files must use schema 2.0. Custom data created using schema 1.0 will not load on CVSM 2.20.00. The Welch Allyn Project Manager is tasked with creating the custom data files using the custom data tool. See DIR 20013600 appendix B. See new models and new material sections below for material numbers.

• CR 50438 - EarlySense Modular Safety Solution Support. Through licensing control, customers can buy the full set of EarlySense features, or only the feature


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set associated with movement, falls, and pressure ulcer management. Note: When a CVSM 2.10.00 device with Early Sense is upgraded to CVSM 2.20.00 Modular Safety Support Solution, the pulse and respiration parameters will no longer be available from the patient motion module until a motion, pulse, and respiration license is installed. The motion, pulse, and respiration license is material number 105870. An authorization code for the license may be generated using SAP. See DIR 70022116 MPS: Platform License Code Generation.

• CR 50439 - Active Directory Support. Allows the facility to use an Active Directory list to authenticate users located within their IT system instead of the Connex users list (for Central Station or Central Station Server deployments only Requires CS 1.6).

• CR 55712 - Patient Rest Mode. Allows devices in the continuous profile connected to a Central Station to go into a mode where the bedside alarms are off while the alarm audio at Central Station remains on. Device alarms still go out the gateway system, and if the device becomes disconnected from CS, all alarms will become audible again with the exception of connectivity alarms. Configuration controls to allow users or the host system to enable/disable patient rest mode are located in the advanced settings>alarms>Audio tab. The user control to enable patient rest mode is located on the Alarms tab. Requires CS 1.6.

• CR 50256 - Remote Configuration Delivery. Devices connected to the customer’s network can download a new configuration over the network and install at next power cycle. Allows user to opt out of installation. Push of new configuration is controlled by facility Biomed at Service Dashboard by device serial number. Requires service Monitor version 1.2 and Service Dashboard 2.0.

• CR 50902 - Added configuration setting to allow the user to enable/disable low perfusion alarms behind Advanced Setting.

Resolved anomalies:

• 35992 - When manual RR selected as an option in advanced settings when in episodic profile, only three manual parameters are available as options in continuous profile.

• 36889 - Patient ID and Location Not Confirmed message remains on screen even though the patient is no longer monitored.

• 37573 - Updates to Error log are not showing up on the CVSM service>error logs window. This was limited to the viewable logs on the device.

• 38421 - SpHbv line prints on report with ES module present in Chinese; it should not. This was not an issue for English (and other non-Chinese languages).

• 38923 - Patient ID clipped on Standby Message when patient is created with maximum characters and continuous monitoring is paused for this patient.

• 49182 - Network name (SSID) is truncated when using more than 16 characters.

• 49450 - CVSM device is unable to send the test to CS when there are special characters ('&' or '<') in the values of the custom modifiers. This is fixed by converting the entire custom data object Value field to XML before sending to the host.

• 50712 Alarm pause does not work properly with manual override. Entering an NIBP value higher than an NIBP value triggering an alarm that was


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subsequently silenced, did not trigger a new alarm. Entering an alarming NIBP value as above while another parameters alarm timer is counting down causes the timer to jump to zero. This was addressed by firing a new physiologic alarm when a new discontinuous reading is alarming.

• 50830 - Call home causes patient records to fail to send.

• 57400 - Scale height and weight are not cleared on the home screen when the value is cleared through keypad. This anomaly appears when taking the weight with a connected scale, if the weight is cleared in the manual tab, it remains on the home screen, and will repopulate the manual tab.

• 59801 – Manually entering a SpO2 saturation value that triggers an alarm may not allow the alarm to be silenced by disabling the saturation alarm.

• 60036 - Manual temperature does not update correctly on devices without SureTemp. Once a value is manually entered for temperature, any further changes are not registered.

• 60104 - Values for SpO2 & PR reappear 3 min after clearing using Manual Override. The issue is due to a timing difference between Nellcor and CVSM, it does not occur with Masimo. This can cause the initial value to reappear after being manually overridden.

• 60366 - Alarm limits are changed to default values when the location of a patient is changed from device. This anomaly only happens if the user changes patient type first.

• 51187 - Updated source code to remove unused strings and to correct the font mapping for Chinese font files. This corrects a deficiency for the ‘Bed exit’ string that was incorrectly mapped, resulting in the string being displayed as question marks on the CVSM UI in Chinese.

Known Issues

Known issues which customers may encounter are listed below. For an aggregate listing of unresolved anomalies encountered in the CVSM 2.20.00 software program, see the Unresolved Anomalies Report, DIR 60043357 Ver. L

• 60320 - Device’s using custom modifiers or custom scores may need to be returned to factory settings to remove the custom data file before using the service tool (version 1.7.0.0) to view device information, perform upgrades, verify and calibrate or configure device settings.

• 55833 - Interval programs will revert to factory defaults when upgrading devices from version 1.71.03.

New Models Models 6700 and 6800 will be offered with 3 new configurations.

Early Sense will be offered with only the feature set associated with movement, falls and pressure ulcer management (no respiration and pulse). These models will carry the F designation in the model number for ES Safety.

Models with custom scoring will have a ‘Y’ or ‘W’ designation in the model number. A ‘W’ will indicate custom scoring without printer, and a ‘Y’ will indicate custom scoring with a printer.

Note: The custom data file is created by the project manager based on the customers’ requirements for customer scoring. The file is not loaded at the time of


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manufacture. The custom scoring models exists as a means to charge for adding the custom data.

Key to model names

Model Parameter

67 = Standard N = Nellcor C = CO2 T = SureTemp P = Printer

68 = Wireless M = Masimo R = RRA E = Braun W=Custom Scoring

H=Hemoglobin/Masimo

S = ES X = None Y=Custom Scoring +Printer

F = ES Safety

X = None

X = None

Examples: 67MFEW-B, 68NFTY-B

New Materials 105870 Motion Pulse and Respiration License – This license will be required for all devices with the EarlySense module to enable the host CVSM to display pulse and respiration from the module. The license is not required to display pulse and respiration from other sources. CVSM (F models) with EarlySense safety will not be provisioned with this license. The license may be purchased as an upgrade for those models. Customer upgrades to add EarlySense will require the license if pulse and respiration were included.

1001050 Connex Custom Scoring Upgrade – Customers purchasing this upgrade will work with a project manager to have their scoring system coded to a custom data file. The file is loaded directly to the device from a flash drive. See new features CR 32257 above for more information.

Action: Customer Care: Reference the current service manual and DFU and current versions of service documentation when providing support for CVSM 2.20.00.

Upgrading CVSM 1.X to 2.20.00 Customer Care is authorized to provide the CVSM 2.20.00 upgrade to the Welch Allyn field sales team and other Welch Allyn employees or contractors on an as requested basis via PartnerConnect. Note: All CVSM must first be upgraded to 1.71.03 and meet minimum HW/SW requirements for a 1.x to 2.x upgrade per 20012631 CVSM/CIWS Min HW/SW Levels. LMR sites using CS 1.2 may not be upgraded to CVSM 2.20.00 until they upgrade to CS 1.6. Contact Kristin Alisanski or Robert Wilmington in Marketing for approval before upgrading these customers.

Required Qualifications before upgrading Customer–owned CVSMs:

Note: Any upgrades not meeting these qualifications may not be upgraded without


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approval by Marketing. Contact Kristin Alisanski or Robert Wilmington in Marketing for approval before upgrading these customers.

Customer owned CVSMs must meet at least one of the following requirements to qualify for a 1.71.03 to 2.20.00 upgrade and meet all compatibility requirements.

Cerner customer, wants CVSM 2.20.00 features; manual entry and/or custom modifiers

Connex VM v. 2.0.1 customer wants CVSM 2.20.00 feature; manual entry, (Connex VM does not support custom modifiers).

CVSM will be connected to Connex CS Customer is purchasing CVSM 2.20.00 devices and wants to standardize

on 2.20.00 Customer requires bug fixes in 2.20.00

CVSM devices in the following categories shall not be updated to 2.20.00 at this time.

Office Profile license installed Device only used in ambulatory setting Devices used with Connex VM other than version 2.0.1 Devices used with Connex VM 2.0.1 customer wants CVSM 2.20 feature;

customer modifiers and/or custom scores CVSM does not meet minimum HW/SW requirements

See the procedure section below to push the package from PartnerConnect.

The upgrade package is built on the WA Service Tool model. Using this model allows WA to push out a generic upgrade package that can be used to upgrade the customer’s fleet. The downside to this strategy is the customer can upgrade any CVSM without regard to the rules listed in this document and 20012631 CVSM/CIWS Min HWSW Levels.

Note: Before deploying the upgrade package to the customer site explain the limitations and rules for upgrading devices to the customer. Customers that do not adhere to these rules risk voiding the devices warranty. For customers upgrading from CVSM 1.71.03 advise them to install the Chinese fonts to avoid seeing a technical alarm for missing fonts every time the device is started. The Chinese fonts appear in the service tool upgrade tab, but are not installed when the Upgrade All button is clicked. Select the Chinese Fonts and IME tables in the right hand pane and click either Add all or Add selected buttons to install.

When updating CVSM version 2.10.00 with EarlySense the Motion Pulse and Respiration license must be installed. Authorization codes to generate the license file may be created in SAP using material number 105870. See DIR 70022116. Follow the standard licensing procedure to install the license. See DIR 80016783.

Customers that have purchased CVSM with EarlySense Safety (F models), may purchase the license to add pulse and respiration. Material number 105870 is an authorization code printed on the

Product service and service centers: When servicing, repairing or upgrading CVSM 2.x devices use the service manual and DFU listed above and the most current versions of service documentation for the CVSM.

Do not update any 1.x devices returned for repair to 2.x unless an upgrade material was purchased or the upgrade was approved by marketing. See contacts above. When upgrading from 1.x to 2.x enclose the CD with DFU and service manual


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material number 105853 with the serviced device.

When upgrading a CVSM to add EarlySense with pulse and respiration the Motion Pulse and Respiration license must be installed. Authorization codes to generate the license file may be created in SAP using material number 105870. See DIR 70022116. Follow the standard licensing procedure to install the license. See DIR 80016783.

Reference to Standards:

21 CFR Part 820, ISO 13485, MPD SOP-0002

Reference documents

Service Manual Welch Allyn Connex® Vital Signs Monitor 6000 Series™ (REF 105901(printed copy) Material number 721495 DIR 80019117 or REF 105853 (CD) DIR 80019117)

Directions for Use Welch Allyn Connex® Vital Signs Monitor 6000 Series™, (REF 721953 (printed copy) Material number 721953, DIR 80019042 or REF 105853 (CD) DIR 80019042)

20012631 CVSM/CIWS Min HW/SW Level Requirements

20013788 CVSM 2.20.00 Release Notes for CVSM (Customer facing)

60062368 Software Release Notes (SRN), CVSM, 2.20.00, RELEASE NOTES

60027700 CVSM Repair and Service Plan

DIR 70022116 MPS: Platform License Code Generation.

DIR 20013600 Deploying Custom Data – WI

DIR 50011359 SWF Custom XML Utility 1.0

20013381 TSB - WAST 1.7 Release

80018295 Welch Allyn Connex Network Installation, Best Practices Overview

20013432 TSB-Flexnet Radio DNS 3.00.02 CVSM/CIWS

Updates: Technical Manual

DFU

Procedures

Repair Tool

Internet/Intranet

Service Strategy:

Only software upgrades from 1.71.03 or 2.10.00 to version 2.20.00 are currently supported; all lesser versions must be upgraded to the appropriate base version first. Software-only upgrades will be delivered by Customer Care on an as requested basis through PartnerConnect. The upgrade package may be pushed to the field sales team or other Welch Allyn users. However, all external customers must meet the required qualifications specified in the action section above or be approved by Marketing or Service Engineering. Customers using the device on ambulatory patients in conjunction with SDK, VM, or Office profile are currently excluded from receiving this upgrade. Limited market release (LMR) customers using Central Station (CS) 1.2 will not be upgraded to CVSM 2.20.00 until they can upgrade to CS 1.6. CVSM 2.20.00 compatibility has some limitations with CS 1.5 and is not compatible with CS 1.2.

Service centers will only provide the software upgrade as part of hardware or parameter upgrade. No CVSMs returned for service with 1.x software will be upgraded to 2.x without a sales order unless approved by Marketing (see contacts


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above).

Any devices returned to service for an issue will be made available to engineering.

The CVSM/CIWS Minimum HW/SW requirements document 20012631 has been revised to provide service and upgrade requirements for CVSM 2.20.00. Only the 1.x devices that meet the upgrade requirements described in 20012631 will qualify for a 1.x to 2.20.00 upgrade.

Loaners will be made available from Product Service.

Software updates distributed to customers via PartnerConnect will be packaged with the most current FSS software updates to provide a complete set of compatible software. Since the release of Welch Allyn Service Tool version 1.6.0.0, the customer no longer has the ability to update the FSS and host software independently. The only option is to perform a complete update of all the software contained in the update package.

Required Tools: Welch Allyn Service tool version 1.7.0.0. DIR 50011232

Required Materials:

105870 Motion Pulse and Respiration License (for CVSM with Early Sense only)

The software is available in SAP: 50011362 SWF, CVSM, 2.20.00

Download CVSM 2.20 Package from PartnerConnect

Package includes:

PMP 2.20.00 140514.PIM

EarlySense 01.06.007.pim

MerlionCore_1.00.03.pim (Braun dock)

ModPG.pim (version 2.05)

pSPO2 2.0.9.pim (Masimo)

PSpO2 1.00.14.pim (Nellcor)

PSTP 2.02.pim (SureTemp)

MicroMediCO2 BL 1.24 + CO2 1.10.02.pim

ChineseFiles.zip (Chinese font file)*

cplt.wsf (Script too create continuous monitoring license, See procedure section)

20013788 A CVSM 2.20.00 Release Notes.pdf

CVSM2.20Upgrade_WAST.wsf (Script auto runs to create upgrade XML files)**

The package is down loaded to:

Windows XP: C:\Program Files \Welch Allyn\RSDS\DefaultProject\WA ServiceTool\Downloads\PMP 2.20.00

Windows 7: C:\Program Files (x86)\Welch Allyn\RSDS\DefaultProject\WA ServiceTool\Downloads\PMP 2.20.00

*Chinese fonts are required to enable landscape printing for trending with continuous monitoring. The Chinese fonts are installed on all CVSMs originally provisioned with version 2.x, some devices upgraded from 1.x will require the Chinese fonts.


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NOTE: If the Chinese fonts are not installed a technical alarm will warn the user every time the device is started. To avoid customer questions regarding the technical alarm insure the Chinese fonts are installed when updating the software.

**Downloaded to the Scripts folder at the same level as the Downloads folder

Quality Process for failed units or components:

All failed parts will be retained by Product Service for further analysis if requested by engineering.

Procedure: Procedure to push a device model package to the PC connected to or managing the device Download CVSM 2.20.00 Package (manual push only)

1. Log on to PartnerConnect: https://welchallynsolutions.com

2. Go to Assets. This may be done by clicking the Assets button in the header.

3. In the Asset field enter the registered computer name of the PC running WAST that will be used to upgrade the CVSM, followed by “_WAST”. If you do not the complete registered name use “*” as a wildcard for characters you are unsure of.

4. Select the instance of WAST by clicking on the asset Name in the list, to open the WAST dashboard screen.

5. Open the list of available packages by clicking the upgrade this asset icon on the right side of the dashboard, select “CVSM 2.20 upgrade”.


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6. Confirm the package appears in the recent actions pane (center screen). The initial status will be; waiting to deliver. After a minute the status will change to: Delivered to agent Package Deployed [CVSM 2.20 upgrade].

If successful the audit log will confirm the scripts were downloaded and the CVSM2.20Upgrade Script ran. The script will create the upgrade XML files in the service tool Inbox and place a shortcut for the license script on the desktop. The “cplt.wsf” is initiated by the user to create the continuous license XML. See Installing the Continuous Monitoring license below.

The package will be downloaded to:

Windows XP: C:\Program Files \Welch Allyn\RSDS\DefaultProject\WA ServiceTool\Downloads\PMP 2.20.00

Windows 7: C:\Program Files (x86)\Welch Allyn\RSDS\DefaultProject\WA ServiceTool\Downloads\PMP 2.20.00

Installing the Continuous Monitoring license

The package contains a script to generate the license XML file for the continuous monitoring license for the customer’s convenience. The licensing application within the service tool may still be used to add licenses but an authorization code would need to be generated using SAP. The script only requires the device serial number.

Icon for WAST dashboard


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The device does not need to connected to the WAST when the license XML is created. The license will automatically install the next time the device is connected.

1. Locate the Continuous Profile License Tool shortcut on the desktop.

2. Double click on the icon to launch, if the security dialog appears click the Open button.

3. Enter the serial number of the device you want to license. The serial number must have 12 digits from 0 thru 9.

4. Click OK. 5. Launch the service tool. 6. If the simple user interface screen appears click Service. 7. Log on as ADMIN with no Password if no biomed account has been created,

otherwise the biomed account may be used. 8. If the device is not connected the license file will be saved to the work list and

install when the device is connected. If the device is connected the license will process immediately, provided the device tab is not open.

9. Connect the CVSM to the PC running the service tool with a USB cable. 10. Power on the CVSM. A message box will inform you the license is being

installed.

11. When the licensing completes the message changes to inform you the license

was installed.


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12. Reboot the CVSM for the license to take effect. 13. Go the Work List tab, select the licensing action for the device, and click the

Work done button to remove the item from the work list. 14. Close any open dialog boxes, and disconnect the CVSM. Troubleshooting tips:

a. If the error installing new license message appears, restart the CVSM and the service tool.

If the license does not automatically install after restarting the service tool and the CVSM, clear the work list and use the license tool to create a new license. b. Verify the correct serial number was entered. If the license lost dialog

appears. It will be necessary to create a new license.

c. Verify the device tab in the service tool is not open. d. Verify the PC has an internet connection. e. If a firewall is present verify port 5093/5094 is open for TCP/IP traffic.

Quality Documents:

All service centers using SAP to record service transactions: For each product serviced, record the service activity in SAP.

All other service centers and Field Service: For each product serviced, complete and file a service report and attach to the service DHR.

Notes:

1. Contact Welch Allyn regarding any questions or concerns from this or other issues. 2. Drawings, illustrations, and part numbers in this document are for reference purposes only and subject to

change.

End of Bulletin

Revision History

Version Description Change # Init Release Date Appr

A Initial release D* GCS D* D*

B

P. 2 CR 32257 change reference in last sentence to DIR 20013600 appendix B

P.7 Correct DIR from 60058360 to 20013600

P.7 Add DIR 50011359 SWF Custom XML

P. 8 Add cplt.wsf (Script too create continuous monitoring license, See procedure section)

D* GCS D* D*


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CVSM2.20Upgrade_WAST.wsf (Script auto runs to create upgrade XML files)** to required materials

P.8 Added **Downloaded to the Scripts folder at the same level as the Downloads folder

C

Update revision history

Update footer to show Rev C

P.1 Change Patient Monitors and Systems to Patient Monitors

P.3 Reference new models and materials in CR 32257

P. 4 Update New models section to include ‘W’ and ‘Y’ models.

P.5 Add table “Key to model names”

P.5 Add 1001050 to new materials section

P.6 Add requirement for upgrades “…and meet all compatibility requirements”. P.6 Add 5th bullet point “• Customer requires bug fixes in 2.20.00”

D* GCS D* D*

D* SEE SAP DIR FOR CHANGE NUMBER, APPROVER NAME AND DATE OF APPROVAL